section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 21:21:7.0.1.1.1.1.1.1,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,A,Subpart A—General Provisions,,§ 600.2 Mailing addresses.,FDA,,,"[70 FR 14981, Mar. 24, 2005, as amended at 74 FR 13114, Mar. 26, 2009; 78 FR 19585, Apr. 2, 2013; 80 FR 18091, Apr. 3, 2015; 79 FR 33090, June 10, 2014]","(a) Licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). Unless otherwise stated in paragraph (c) of this section, or as otherwise prescribed by FDA regulation, all submissions to CBER referenced in parts 600 through 680 of this chapter, as applicable, must be sent to: Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. Examples of such submissions include: Biologics license applications (BLAs) and their amendments and supplements, biological product deviation reports, fatality reports, and other correspondence. Biological products samples must not be sent to this address but must be sent to the address in paragraph (c) of this section. (b) Licensed biological products regulated by the Center for Drug Evaluation and Research (CDER). Unless otherwise stated in paragraphs (b)(1), (b)(2), or (c) of this section, or as otherwise prescribed by FDA regulation, all submissions to CDER referenced in parts 600, 601, and 610 of this chapter, as applicable, must be sent to: CDER Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901B Ammendale Rd., Beltsville, MD 20705. Examples of such submissions include: BLAs and their amendments and supplements, and other correspondence. (1) Biological Product Deviation Reporting (CDER). All biological product deviation reports required under § 600.14 must be sent to: Division of Compliance Risk Management and Surveillance, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. (2) Advertising and Promotional Labeling (CDER). All advertising and promotional labeling supplements required under § 601.12(f) of this chapter must be sent to: Division of Drug Marketing, Advertising and Communication, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. (c) Samples and Protocols for licensed biological products regulated by CBER or CDER. (1) Biological product samples and/or protocols, other than radioactive biological product samples and protocols, required under §§ 600.13, 600.22, 601.15, 610.2, 660.6, 660.36, or 660.46 of this chapter must be sent by courier service to: Food and Drug Administration, Center for Biologics Evaluation and Research, ATTN: Sample Custodian, 10903 New Hampshire Ave., Bldg. 75, Rm. G707, Silver Spring, MD 20993-0002. The protocol(s) may be placed in the box used to ship the samples to CBER. A cover letter should not be included when submitting the protocol with the sample unless it contains pertinent information affecting the release of the lot. (2) Radioactive biological products required under § 610.2 of this chapter must be sent by courier service to: Food and Drug Administration, Center for Biologics Evaluation and Research, ATTN: Sample Custodian, c/o White Oak Radiation Safety Program, 10903 New Hampshire Ave., Bldg. 52-72, Rm. G406A, Silver Spring, MD 20993-0002. (d) Address information for submissions to CBER and CDER other than those listed in parts 600 through 680 of this chapter are included directly in the applicable regulations. (e) Obtain updated mailing address information for biological products regulated by CBER at http://www.fda.gov/BiologicsBloodVaccines/default.htm , or for biological products regulated by CDER at http://www.fda.gov/Drugs/default.htm." 21:21:7.0.1.1.1.1.1.2,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,A,Subpart A—General Provisions,,§ 600.3 Definitions.,FDA,,,"[38 FR 32048, Nov. 20, 1973, as amended at 40 FR 31313, July 25, 1975; 55 FR 11014, Mar. 26, 1990; 61 FR 24232, May 14, 1996; 62 FR 39901, July 24, 1997; 64 FR 56449, Oct. 20, 1999; 65 FR 66634, Nov. 7, 2000; 69 FR 18766, Apr. 8, 2004; 70 FR 14982, Mar. 24, 2005; 73 FR 39610, July 10, 2008; 77 FR 26174, May 3, 2012; 85 FR 10063, Feb. 21, 2020]","As used in this subchapter: (a) Act means the Public Health Service Act (58 Stat. 682), approved July 1, 1944. (b) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated. (c) Commissioner of Food and Drugs means the Commissioner of the Food and Drug Administration. (d) Center for Biologics Evaluation and Research means Center for Biologics Evaluation and Research of the Food and Drug Administration. (e) State means a State or the District of Columbia, Puerto Rico, or the Virgin Islands. (f) Possession includes among other possessions, Puerto Rico and the Virgin Islands. (g) Products includes biological products and trivalent organic arsenicals. (h) Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. (1) A virus is interpreted to be a product containing the minute living cause of an infectious disease and includes but is not limited to filterable viruses, bacteria, rickettsia, fungi, and protozoa. (2) A therapeutic serum is a product obtained from blood by removing the clot or clot components and the blood cells. (3) A toxin is a product containing a soluble substance poisonous to laboratory animals or to man in doses of 1 milliliter or less (or equivalent in weight) of the product, and having the property, following the injection of non-fatal doses into an animal, of causing to be produced therein another soluble substance which specifically neutralizes the poisonous substance and which is demonstrable in the serum of the animal thus immunized. (4) An antitoxin is a product containing the soluble substance in serum or other body fluid of an immunized animal which specifically neutralizes the toxin against which the animal is immune. (5) A product is analogous: (i) To a virus if prepared from or with a virus or agent actually or potentially infectious, without regard to the degree of virulence or toxicogenicity of the specific strain used. (ii) To a therapeutic serum, if composed of whole blood or plasma or containing some organic constituent or product other than a hormone or an amino acid, derived from whole blood, plasma, or serum. (iii) To a toxin or antitoxin, if intended, irrespective of its source of origin, to be applicable to the prevention, treatment, or cure of disease or injuries of man through a specific immune process. (6) A protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. When two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer for purposes of this paragraph (h)(6) will be based on the total number of amino acids in those chains, and will not be limited to the number of amino acids in a contiguous sequence. (i) Trivalent organic arsenicals means arsphenamine and its derivatives (or any other trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of diseases or injuries of man. (j) A product is deemed applicable to the prevention, treatment, or cure of diseases or injuries of man irrespective of the mode of administration or application recommended, including use when intended through administration or application to a person as an aid in diagnosis, or in evaluating the degree of susceptibility or immunity possessed by a person, and including also any other use for purposes of diagnosis if the diagnostic substance so used is prepared from or with the aid of a biological product. (k) Proper name, as applied to a product, means the name designated in the license for use upon each package of the product. (l) Dating period means the period beyond which the product cannot be expected beyond reasonable doubt to yield its specific results. (m) Expiration date means the calendar month and year, and where applicable, the day and hour, that the dating period ends. (n) The word standards means specifications and procedures applicable to an establishment or to the manufacture or release of products, which are prescribed in this subchapter or established in the biologics license application designed to insure the continued safety, purity, and potency of such products. (o) The word continued as applied to the safety, purity and potency of products is interpreted to apply to the dating period. (p) The word safety means the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time. (q) The word sterility is interpreted to mean freedom from viable contaminating microorganisms, as determined by the tests conducted under § 610.12 of this chapter. (r) Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances. (s) The word potency is interpreted to mean the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result. (t) Manufacturer means any legal person or entity engaged in the manufacture of a product subject to license under the act; “Manufacturer” also includes any legal person or entity who is an applicant for a license where the applicant assumes responsibility for compliance with the applicable product and establishment standards. (u) Manufacture means all steps in propagation or manufacture and preparation of products and includes but is not limited to filling, testing, labeling, packaging, and storage by the manufacturer. (v) Location includes all buildings, appurtenances, equipment and animals used, and personnel engaged by a manufacturer within a particular area designated by an address adequate for identification. (w) Establishment has the same meaning as “facility” in section 351 of the Public Health Service Act and includes all locations. (x) Lot means that quantity of uniform material identified by the manufacturer as having been thoroughly mixed in a single vessel. (y) A filling refers to a group of final containers identical in all respects, which have been filled with the same product from the same bulk lot without any change that will affect the integrity of the filling assembly. (z) Process refers to a manufacturing step that is performed on the product itself which may affect its safety, purity or potency, in contrast to such manufacturing steps which do not affect intrinsically the safety, purity or potency of the product. (aa) Selling agent or distributor means any person engaged in the unrestricted distribution, other than by sale at retail, of products subject to license. (bb) Container (referred to also as “final container”) is the immediate unit, bottle, vial, ampule, tube, or other receptacle containing the product as distributed for sale, barter, or exchange. (cc) Package means the immediate carton, receptacle, or wrapper, including all labeling matter therein and thereon, and the contents of the one or more enclosed containers. If no package, as defined in the preceding sentence, is used, the container shall be deemed to be the package. (dd) Label means any written, printed, or graphic matter on the container or package or any such matter clearly visible through the immediate carton, receptacle, or wrapper. (ee) Radioactive biological product means a biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide. (ff) Amendment is the submission of information to a pending license application or supplement, to revise or modify the application as originally submitted. (gg) Supplement is a request to approve a change in an approved license application. (hh) Distributed means the biological product has left the control of the licensed manufacturer. (ii) Control means having responsibility for maintaining the continued safety, purity, and potency of the product and for compliance with applicable product and establishment standards, and for compliance with current good manufacturing practices. (jj) Assess the effects of the change , as used in § 601.12 of this chapter, means to evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a product as these factors may relate to the safety or effectiveness of the product. (kk) Specification , as used in § 601.12 of this chapter, means the quality standard (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of products, intermediates, raw materials, reagents, components, in-process materials, container closure systems, and other materials used in the production of a product. For the purpose of this definition, acceptance criteria means numerical limits, ranges, or other criteria for the tests described. (ll) Complete response letter means a written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in a biologics license application or supplement that must be satisfactorily addressed before it can be approved. (mm) Resubmission means a submission by the biologics license applicant or supplement applicant of all materials needed to fully address all deficiencies identified in the complete response letter. A biologics license application or supplement for which FDA issued a complete response letter, but which was withdrawn before approval and later submitted again, is not a resubmission." 21:21:7.0.1.1.1.2.1.1,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,B,Subpart B—Establishment Standards,,§ 600.10 Personnel.,FDA,,,"[38 FR 32048, Nov. 20, 1973, as amended at 49 FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997; 68 FR 75119, Dec. 30, 2003]","(a) [Reserved] (b) Personnel. Personnel shall have capabilities commensurate with their assigned functions, a thorough understanding of the manufacturing operations which they perform, the necessary training and experience relating to individual products, and adequate information concerning the application of the pertinent provisions of this subchapter to their respective functions. Personnel shall include such professionally trained persons as are necessary to insure the competent performance of all manufacturing processes. (c) Restrictions on personnel —(1) Specific duties. Persons whose presence can affect adversely the safety and purity of a product shall be excluded from the room where the manufacture of a product is in progress. (2) Sterile operations. Personnel performing sterile operations shall wear clean or sterilized protective clothing and devices to the extent necessary to protect the product from contamination. (3) Pathogenic viruses and spore-forming organisms. Persons working with viruses pathogenic for man or with spore-forming microorganisms, and persons engaged in the care of animals or animal quarters, shall be excluded from areas where other products are manufactured, or such persons shall change outer clothing, including shoes, or wear protective covering prior to entering such areas. (4) Live vaccine work areas. Persons may not enter a live vaccine processing area after having worked with other infectious agents in any other laboratory during the same working day. Only persons actually concerned with propagation of the culture, production of the vaccine, and unit maintenance, shall be allowed in live vaccine processing areas when active work is in progress. Casual visitors shall be excluded from such units at all times and all others having business in such areas shall be admitted only under supervision. Street clothing, including shoes, shall be replaced or covered by suitable laboratory clothing before entering a live vaccine processing unit. Persons caring for animals used in the manufacture of live vaccines shall be excluded from other animal quarters and from contact with other animals during the same working day." 21:21:7.0.1.1.1.2.1.2,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,B,Subpart B—Establishment Standards,,"§ 600.11 Physical establishment, equipment, animals, and care.",FDA,,,"[38 FR 32048, Nov. 20, 1973, as amended at 41 FR 10428, Mar. 11, 1976; 49 FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 68 FR 75119, Dec. 30, 2003; 70 FR 14982, Mar. 24, 2005; 72 FR 59003, Oct. 18, 2007; 80 FR 18092, Apr. 3, 2015]","(a) Work areas. All rooms and work areas where products are manufactured or stored shall be kept orderly, clean, and free of dirt, dust, vermin and objects not required for manufacturing. Precautions shall be taken to avoid clogging and back-siphonage of drainage systems. Precautions shall be taken to exclude extraneous infectious agents from manufacturing areas. Work rooms shall be well lighted and ventilated. The ventilation system shall be arranged so as to prevent the dissemination of microorganisms from one manufacturing area to another and to avoid other conditions unfavorable to the safety of the product. Filling rooms, and other rooms where open, sterile operations are conducted, shall be adequate to meet manufacturing needs and such rooms shall be constructed and equipped to permit thorough cleaning and to keep air-borne contaminants at a minimum. If such rooms are used for other purposes, they shall be cleaned and prepared prior to use for sterile operations. Refrigerators, incubators and warm rooms shall be maintained at temperatures within applicable ranges and shall be free of extraneous material which might affect the safety of the product. (b) Equipment. Apparatus for sterilizing equipment and the method of operation shall be such as to insure the destruction of contaminating microorganisms. The effectiveness of the sterilization procedure shall be no less than that achieved by an attained temperature of 121.5 °C maintained for 20 minutes by saturated steam or by an attained temperature of 170 °C maintained for 2 hours with dry heat. Processing and storage containers, filters, filling apparatus, and other pieces of apparatus and accessory equipment, including pipes and tubing, shall be designed and constructed to permit thorough cleaning and, where possible, inspection for cleanliness. All surfaces that come in contact with products shall be clean and free of surface solids, leachable contaminants, and other materials that will hasten the deterioration of the product or otherwise render it less suitable for the intended use. For products for which sterility is a factor, equipment shall be sterile, unless sterility of the product is assured by subsequent procedures. (c) Laboratory and bleeding rooms. Rooms used for the processing of products, including bleeding rooms, shall be effectively fly-proofed and kept free of flies and vermin. Such rooms shall be so constructed as to insure freedom from dust, smoke and other deleterious substances and to permit thorough cleaning and disinfection. Rooms for animal injection and bleeding, and rooms for smallpox vaccine animals, shall be disinfected and be provided with the necessary water, electrical and other services. (d) Animal quarters and stables. Animal quarters, stables and food storage areas shall be of appropriate construction, fly-proofed, adequately lighted and ventilated, and maintained in a clean, vermin-free and sanitary condition. No manure or refuse shall be stored as to permit the breeding of flies on the premises, nor shall the establishment be located in close proximity to off-property manure or refuse storage capable of engendering fly breeding. (e) Restrictions on building and equipment use —(1) Work of a diagnostic nature. Laboratory procedures of a clinical diagnostic nature involving materials that may be contaminated, shall not be performed in space used for the manufacture of products except that manufacturing space which is used only occasionally may be used for diagnostic work provided spore-forming pathogenic microorganisms are not involved and provided the space is thoroughly cleaned and disinfected before the manufacture of products is resumed. (2) Spore-forming organisms for supplemental sterilization procedure control test. Spore-forming organisms used as an additional control in sterilization procedures may be introduced into areas used for the manufacture of products, only for the purposes of the test and only immediately before use for such purposes: Provided, That (i) the organism is not pathogenic for man or animals and does not produce pyrogens or toxins, (ii) the culture is demonstrated to be pure, (iii) transfer of test cultures to culture media shall be limited to the sterility test area or areas designated for work with spore-forming organisms, (iv) each culture be labeled with the name of the microorganism and the statement “Caution: microbial spores. See directions for storage, use and disposition.”, and (v) the container of each culture is designed to withstand handling without breaking. (3) Work with spore-forming microorganisms. (i) Manufacturing processes using spore-forming microorganisms conducted in a multiproduct manufacturing site must be performed under appropriate controls to prevent contamination of other products and areas within the site. Prevention of spore contamination can be achieved by using a separate dedicated building or by using process containment if manufacturing is conducted in a multiproduct manufacturing building. All product and personnel movement between the area where the spore-forming microorganisms are manufactured and other manufacturing areas must be conducted under conditions that will prevent the introduction of spores into other areas of the facility. (ii) If process containment is employed in a multiproduct manufacturing area, procedures must be in place to demonstrate adequate removal of the spore-forming microorganism(s) from the manufacturing area for subsequent manufacture of other products. These procedures must provide for adequate removal or decontamination of the spore-forming microorganisms on and within manufacturing equipment, facilities, and ancillary room items as well as the removal of disposable or product dedicated items from the manufacturing area. Environmental monitoring specific for the spore-forming microorganism(s) must be conducted in adjacent areas during manufacturing operations and in the manufacturing area after completion of cleaning and decontamination. (4) Live vaccine processing. Live vaccine processing must be performed under appropriate controls to prevent cross contamination of other products and other manufacturing areas within the building. Appropriate controls must include, at a minimum: (i)(A) Using a dedicated manufacturing area that is either in a separate building, in a separate wing of a building, or in quarters at the blind end of a corridor and includes adequate space and equipment for all processing steps up to, but not including, filling into final containers; and (B) Not conducting test procedures that potentially involve the presence of microorganisms other than the vaccine strains or the use of tissue culture cell lines other than primary cultures in space used for processing live vaccine; or (ii) If manufacturing is conducted in a multiproduct manufacturing building or area, using procedural controls, and where necessary, process containment. Process containment is deemed to be necessary unless procedural controls are sufficient to prevent cross contamination of other products and other manufacturing areas within the building. Process containment is a system designed to mechanically isolate equipment or an area that involves manufacturing using live vaccine organisms. All product, equipment, and personnel movement between distinct live vaccine processing areas and between live vaccine processing areas and other manufacturing areas, up to, but not including, filling in final containers, must be conducted under conditions that will prevent cross contamination of other products and manufacturing areas within the building, including the introduction of live vaccine organisms into other areas. In addition, written procedures and effective processes must be in place to adequately remove or decontaminate live vaccine organisms from the manufacturing area and equipment for subsequent manufacture of other products. Written procedures must be in place for verification that processes to remove or decontaminate live vaccine organisms have been followed. (5) Equipment and supplies—contamination. Equipment and supplies used in work on or otherwise exposed to any pathogenic or potentially pathogenic agent shall be kept separated from equipment and supplies used in the manufacture of products to the extent necessary to prevent cross-contamination. (f) Animals used in manufacture —(1) Care of animals used in manufacturing. Caretakers and attendants for animals used for the manufacture of products shall be sufficient in number and have adequate experience to insure adequate care. Animal quarters and cages shall be kept in sanitary condition. Animals on production shall be inspected daily to observe response to production procedures. Animals that become ill for reasons not related to production shall be isolated from other animals and shall not be used for production until recovery is complete. Competent veterinary care shall be provided as needed. (2) Quarantine of animals —(i) General. No animal shall be used in processing unless kept under competent daily inspection and preliminary quarantine for a period of at least 7 days before use, or as otherwise provided in this subchapter. Only healthy animals free from detectable communicable diseases shall be used. Animals must remain in overt good health throughout the quarantine periods and particular care shall be taken during the quarantine periods to reject animals of the equine genus which may be infected with glanders and animals which may be infected with tuberculosis. (ii) Quarantine of monkeys. In addition to observing the pertinent general quarantine requirements, monkeys used as a source of tissue in the manufacture of vaccine shall be maintained in quarantine for at least 6 weeks prior to use, except when otherwise provided in this part. Only monkeys that have reacted negatively to tuberculin at the start of the quarantine period and again within 2 weeks prior to use shall be used in the manufacture of vaccine. Due precaution shall be taken to prevent cross-infection from any infected or potentially infected monkeys on the premises. Monkeys to be used in the manufacture of a live vaccine shall be maintained throughout the quarantine period in cages closed on all sides with solid materials except the front which shall be screened, with no more than two monkeys housed in one cage. Cage mates shall not be interchanged. (3) Immunization against tetanus. Horses and other animals susceptible to tetanus, that are used in the processing steps of the manufacture of biological products, shall be treated adequately to maintain immunity to tetanus. (4) Immunization and bleeding of animals used as a source of products. Toxins or other nonviable antigens administered in the immunization of animals used in the manufacture of products shall be sterile. Viable antigens, when so used, shall be free of contaminants, as determined by appropriate tests prior to use. Injections shall not be made into horses within 6 inches of bleeding site. Horses shall not be bled for manufacturing purposes while showing persistent general reaction or local reaction near the site of bleeding. Blood shall not be used if it was drawn within 5 days of injecting the animals with viable microorganisms. Animals shall not be bled for manufacturing purposes when they have an intercurrent disease. Blood intended for use as a source of a biological product shall be collected in clean, sterile vessels. When the product is intended for use by injection, such vessels shall also be pyrogen-free. (5) [Reserved] (6) Reporting of certain diseases. In cases of actual or suspected infection with foot and mouth disease, glanders, tetanus, anthrax, gas gangrene, equine infectious anemia; equine encephalomyelitis, or any of the pock diseases among animals intended for use or used in the manufacture of products, the manufacturer shall immediately notify the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(a) or (b)). (7) Monkeys used previously for experimental or test purposes. Monkeys that have been used previously for experimental or test purposes with live microbiological agents shall not be used as a source of kidney tissue for the manufacture of vaccine. Except as provided otherwise in this subchapter, monkeys that have been used previously for other experimental or test purposes may be used as a source of kidney tissue upon their return to a normal condition, provided all quarantine requirements have been met. (8) Necropsy examination of monkeys. Each monkey used in the manufacture of vaccine shall be examined at necropsy under the direction of a qualified pathologist, physician, or veterinarian having experience with diseases of monkeys, for evidence of ill health, particularly for (i) evidence of tuberculosis, (ii) presence of herpes-like lesions, including eruptions or plaques on or around the lips, in the buccal cavity or on the gums, and (iii) signs of conjunctivitis. If there are any such signs or other significant gross pathological lesions, the tissue shall not be used in the manufacture of vaccine. (g) Filling procedures. Filling procedures shall be such as will not affect adversely the safety, purity or potency of the product. (h) Containers and closures. All final containers and closures shall be made of material that will not hasten the deterioration of the product or otherwise render it less suitable for the intended use. All final containers and closures shall be clean and free of surface solids, leachable contaminants and other materials that will hasten the deterioration of the product or otherwise render it less suitable for the intended use. After filling, sealing shall be performed in a manner that will maintain the integrity of the product during the dating period. In addition, final containers and closures for products intended for use by injection shall be sterile and free from pyrogens. Except as otherwise provided in the regulations of this subchapter, final containers for products intended for use by injection shall be colorless and sufficiently transparent to permit visual examination of the contents under normal light. As soon as possible after filling final containers shall be labeled as prescribed in § 610.60 et seq. of this chapter, except that final containers may be stored without such prescribed labeling provided they are stored in a sealed receptacle labeled both inside and outside with at least the name of the product, the lot number, and the filling identification." 21:21:7.0.1.1.1.2.1.3,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,B,Subpart B—Establishment Standards,,§ 600.12 Records.,FDA,,,"[38 FR 32048, Nov. 20, 1973, as amended at 49 FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 70 FR 14982, Mar. 24, 2005]","(a) Maintenance of records. Records shall be made, concurrently with the performance, of each step in the manufacture and distribution of products, in such a manner that at any time successive steps in the manufacture and distribution of any lot may be traced by an inspector. Such records shall be legible and indelible, shall identify the person immediately responsible, shall include dates of the various steps, and be as detailed as necessary for clear understanding of each step by one experienced in the manufacture of products. (b) Records retention —(1) General. Records shall be retained for such interval beyond the expiration date as is necessary for the individual product, to permit the return of any clinical report of unfavorable reactions. The retention period shall be no less than five years after the records of manufacture have been completed or six months after the latest expiration date for the individual product, whichever represents a later date. (2) Records of recall. Complete records shall be maintained pertaining to the recall from distribution of any product upon notification by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research, to recall for failure to conform with the standards prescribed in the regulations of this subchapter, because of deterioration of the product or for any other factor by reason of which the distribution of the product would constitute a danger to health. (3) Suspension of requirement for retention. The Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research, may authorize the suspension of the requirement to retain records of a specific manufacturing step upon a showing that such records no longer have significance for the purposes for which they were made: Provided, That a summary of such records shall be retained. (c) Records of sterilization of equipment and supplies. Records relating to the mode of sterilization, date, duration, temperature and other conditions relating to each sterilization of equipment and supplies used in the processing of products shall be made by means of automatic recording devices or by means of a system of recording which gives equivalent assurance of the accuracy and reliability of the record. Such records shall be maintained in a manner that permits an identification of the product with the particular manufacturing process to which the sterilization relates. (d) Animal necropsy records. A necropsy record shall be kept on each animal from which a biological product has been obtained and which dies or is sacrificed while being so used. (e) Records in case of divided manufacturing responsibility. If two or more establishments participate in the manufacture of a product, the records of each such establishment must show plainly the degree of its responsibility. In addition, each participating manufacturer shall furnish to the manufacturer who prepares the product in final form for sale, barter or exchange, a copy of all records relating to the manufacturing operations performed by such participating manufacturer insofar as they concern the safety, purity and potency of the lots of the product involved, and the manufacturer who prepares the product in final form shall retain a complete record of all the manufacturing operations relating to the product." 21:21:7.0.1.1.1.2.1.4,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,B,Subpart B—Establishment Standards,,§ 600.13 Retention samples.,FDA,,,"[41 FR 10428, Mar. 11, 1976, as amended at 49 FR 23833, June 8, 1984; 50 FR 4133, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 70 FR 14982, Mar. 24, 2005]","Manufacturers shall retain for a period of at least 6 months after the expiration date, unless a different time period is specified in additional standards, a quantity of representative material of each lot of each product, sufficient for examination and testing for safety and potency, except Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood Cells, Plasma, and Source Plasma and Allergenic Products prepared to a physician's prescription. Samples so retained shall be selected at random from either final container material, or from bulk and final containers, provided they include at least one final container as a final package, or package-equivalent of such filling of each lot of the product as intended for distribution. Such sample material shall be stored at temperatures and under conditions which will maintain the identity and integrity of the product. Samples retained as required in this section shall be in addition to samples of specific products required to be submitted to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research (see mailing addresses in § 600.2). Exceptions may be authorized by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research, when the lot yields relatively few final containers and when such lots are prepared by the same method in large number and in close succession." 21:21:7.0.1.1.1.2.1.5,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,B,Subpart B—Establishment Standards,,§ 600.14 Reporting of biological product deviations by licensed manufacturers.,FDA,,,"[65 FR 66634, Nov. 7, 2000, as amended at 70 FR 14982, Mar. 24, 2005; 80 FR 18092, Apr. 3, 2015]","(a) Who must report under this section? (1) You, the manufacturer who holds the biological product license and who had control over the product when the deviation occurred, must report under this section. If you arrange for another person to perform a manufacturing, holding, or distribution step, while the product is in your control, that step is performed under your control. You must establish, maintain, and follow a procedure for receiving information from that person on all deviations, complaints, and adverse events concerning the affected product. (2) Exceptions: (i) Persons who manufacture only in vitro diagnostic products that are not subject to licensing under section 351 of the Public Health Service Act do not report biological product deviations for those products under this section but must report in accordance with part 803 of this chapter; (ii) Persons who manufacture blood and blood components, including licensed manufacturers, unlicensed registered blood establishments, and transfusion services, do not report biological product deviations for those products under this section but must report under § 606.171 of this chapter; (iii) Persons who manufacture Source Plasma or any other blood component and use that Source Plasma or any other blood component in the further manufacture of another licensed biological product must report: (A) Under § 606.171 of this chapter, if a biological product deviation occurs during the manufacture of that Source Plasma or any other blood component; or (B) Under this section, if a biological product deviation occurs after the manufacture of that Source Plasma or any other blood component, and during manufacture of the licensed biological product. (b) What do I report under this section? You must report any event, and information relevant to the event, associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of a licensed biological product, if that event meets all the following criteria: (1) Either: (i) Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or (ii) Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and (2) Occurs in your facility or another facility under contract with you; and (3) Involves a distributed biological product. (c) When do I report under this section? You should report a biological product deviation as soon as possible but you must report at a date not to exceed 45-calendar days from the date you, your agent, or another person who performs a manufacturing, holding, or distribution step under your control, acquire information reasonably suggesting that a reportable event has occurred. (d) How do I report under this section You must report on Form FDA-3486. (e) Where do I report under this section? (1) For biological products regulated by the Center for Biologics Evaluation and Research (CBER), send the completed Form FDA 3486 to the CBER Document Control Center (see mailing address in § 600.2(a)), or submit electronically using CBER's electronic Web-based application. (2) For biological products regulated by the Center for Drug Evaluation and Research (CDER), send the completed Form FDA-3486 to the Division of Compliance Risk Management and Surveillance (HFD-330) (see mailing addresses in § 600.2). CDER does not currently accept electronic filings. (3) If you make a paper filing, you should identify on the envelope that a biological product deviation report (BPDR) is enclosed. (f) How does this regulation affect other FDA regulations? This part supplements and does not supersede other provisions of the regulations in this chapter. All biological product deviations, whether or not they are required to be reported under this section, should be investigated in accordance with the applicable provisions of parts 211 and 820 of this chapter." 21:21:7.0.1.1.1.2.1.6,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,B,Subpart B—Establishment Standards,,§ 600.15 Temperatures during shipment.,FDA,,,"[39 FR 39872, Nov. 12, 1974, as amended at 49 FR 23833, June 8, 1984; 50 FR 4133, Jan. 29, 1985; 50 FR 9000, Mar. 6, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR 56449, Oct. 20, 1999]","The following products shall be maintained during shipment at the specified temperatures: (a) Products. (b) Exemptions. Exemptions or modifications shall be made only upon written approval, in the form of a supplement to the biologics license application, approved by the Director, Center for Biologics Evaluation and Research." 21:21:7.0.1.1.1.3.1.1,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,C,Subpart C—Establishment Inspection,,§ 600.20 Inspectors.,FDA,,,"[38 FR 32048, Nov. 20, 1973]","Inspections shall be made by an officer of the Food and Drug Administration having special knowledge of the methods used in the manufacture and control of products and designated for such purposes by the Commissioner of Food and Drugs, or by any officer, agent, or employee of the Department of Health and Human Services specifically designated for such purpose by the Secretary." 21:21:7.0.1.1.1.3.1.2,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,C,Subpart C—Establishment Inspection,,§ 600.21 Time of inspection.,FDA,,,"[38 FR 32048, Nov. 20, 1973, as amended at 48 FR 26314, June 7, 1983; 64 FR 56449, Oct. 20, 1999; 84 FR 12508, Apr. 2, 2019]",The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired. 21:21:7.0.1.1.1.3.1.3,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,C,Subpart C—Establishment Inspection,,§ 600.22 [Reserved],FDA,,,, 21:21:7.0.1.1.1.4.1.1,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,D,Subpart D—Reporting of Adverse Experiences,,§ 600.80 Postmarketing reporting of adverse experiences.,FDA,,,"[59 FR 54042, Oct. 27, 1994, as amended at 62 FR 34168, June 25, 1997; 62 FR 52252, Oct. 7, 1997; 63 FR 14612, Mar. 26, 1998; 64 FR 56449, Oct. 20, 1999; 70 FR 14982, Mar. 24, 2005; 79 FR 33090, June 10, 2014]","(a) Definitions. The following definitions of terms apply to this section: Adverse experience. Any adverse event associated with the use of a biological product in humans, whether or not considered product related, including the following: An adverse event occurring in the course of the use of a biological product in professional practice; an adverse event occurring from overdose of the product whether accidental or intentional; an adverse event occurring from abuse of the product; an adverse event occurring from withdrawal of the product; and any failure of expected pharmacological action. Blood Component. As defined in § 606.3(c) of this chapter. Disability. A substantial disruption of a person's ability to conduct normal life functions. Individual case safety report (ICSR). A description of an adverse experience related to an individual patient or subject. ICSR attachments. Documents related to the adverse experience described in an ICSR, such as medical records, hospital discharge summaries, or other documentation. Life-threatening adverse experience. Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse experience that, had it occurred in a more severe form, might have caused death. Serious adverse experience. Any adverse experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. Unexpected adverse experience : Any adverse experience that is not listed in the current labeling for the biological product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater severity or specificity. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents. “Unexpected,” as used in this definition, refers to an adverse experience that has not been previously observed (i.e., included in the labeling) rather than from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product. (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this chapter must promptly review all adverse experience information pertaining to its product obtained or otherwise received by the applicant from any source, foreign or domestic, including information derived from commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers. Applicants are not required to resubmit to FDA adverse product experience reports forwarded to the applicant by FDA; applicants, however, must submit all followup information on such reports to FDA. Any person subject to the reporting requirements under paragraph (c) of this section must also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse experiences to FDA. (c) Reporting requirements. The applicant must submit to FDA postmarketing 15-day Alert reports and periodic safety reports pertaining to its biological product as described in this section. These reports must be submitted to the Agency in electronic format as described in paragraph (h)(1) of this section, except as provided in paragraph (h)(2) of this section. (1)(i) Postmarketing 15-day “Alert reports”. The applicant must report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but no later than 15 calendar days from initial receipt of the information by the applicant. (ii) Postmarketing 15-day “Alert reports”—followup. The applicant must promptly investigate all adverse experiences that are the subject of these postmarketing 15-day Alert reports and must submit followup reports within 15 calendar days of receipt of new information or as requested by FDA. If additional information is not obtainable, records should be maintained of the unsuccessful steps taken to seek additional information. (iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of postmarketing 15-day Alert reports, also apply to any person whose name appears on the label of a licensed biological product as a manufacturer, packer, distributor, shared manufacturer, joint manufacturer, or any other participant involved in divided manufacturing. To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of persons other than the applicant of the final biological product may be met by submission of all reports of serious adverse experiences to the applicant of the final product. If a person elects to submit adverse experience reports to the applicant rather than to FDA, the person must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the person, and the applicant must then comply with the requirements of this section. Under this circumstance, a person who elects to submit reports to the applicant of the final product shall maintain a record of this action which must include: (A) A copy of all adverse biological product experience reports submitted to the applicant of the final product; (B) The date the report was received by the person; (C) The date the report was submitted to the applicant of the final product; and— (D) The name and address of the applicant of the final product. (2) Periodic adverse experience reports. (i) The applicant must report each adverse experience not reported under paragraph (c)(1)(i) of this section at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The applicant must submit each quarterly report within 30 days of the close of the quarter (the first quarter beginning on the date of issuance of the biologics license) and each annual report within 60 days of the anniversary date of the issuance of the biologics license. Upon written notice, FDA may extend or reestablish the requirement that an applicant submit quarterly reports, or require that the applicant submit reports under this section at different times than those stated. Followup information to adverse experiences submitted in a periodic report may be submitted in the next periodic report. (ii) Each periodic report is required to contain: (A) Descriptive information. ( 1 ) A narrative summary and analysis of the information in the report; ( 2 ) An analysis of the 15-day Alert reports submitted during the reporting interval (all 15-day Alert reports being appropriately referenced by the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports, adverse reaction term(s), and date of submission to FDA); ( 3 ) A history of actions taken since the last report because of adverse experiences (for example, labeling changes or studies initiated); ( 4 ) An index consisting of a line listing of the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports and adverse reaction term(s) for ICSRs submitted under paragraph (c)(2)(ii)(B) of this section; and (B) ICSRs for serious, expected and, nonserious adverse experiences. An ICSR for each adverse experience not reported under paragraph (c)(1)(i) of this section (all serious, expected and nonserious adverse experiences). All such ICSRs must be submitted to FDA (either individually or in one or more batches) within the timeframe specified in paragraph (c)(2)(i) of this section. ICSRs must only be submitted to FDA once. (iii) Periodic reporting, except for information regarding 15-day Alert reports, does not apply to adverse experience information obtained from postmarketing studies (whether or not conducted under an investigational new drug application), from reports in the scientific literature, and from foreign marketing experience. (d) Scientific literature. A 15-day Alert report based on information in the scientific literature must be accompanied by a copy of the published article. The 15-day Alert reporting requirements in paragraph (c)(1)(i) of this section (i.e., serious, unexpected adverse experiences) apply only to reports found in scientific and medical journals either as case reports or as the result of a formal clinical trial. (e) Postmarketing studies. Applicants are not required to submit a 15-day Alert report under paragraph (c) of this section for an adverse experience obtained from a postmarketing clinical study (whether or not conducted under a biological investigational new drug application) unless the applicant concludes that there is a reasonable possibility that the product caused the adverse experience. (f) Information reported on ICSRs for nonvaccine biological products. ICSRs for nonvaccine biological products include the following information: (1) Patient information. (i) Patient identification code; (ii) Patient age at the time of adverse experience, or date of birth; (iii) Patient gender; and (iv) Patient weight. (2) Adverse experience. (i) Outcome attributed to adverse experience; (ii) Date of adverse experience; (iii) Date of report; (iv) Description of adverse experience (including a concise medical narrative); (v) Adverse experience term(s); (vi) Description of relevant tests, including dates and laboratory data; and (vii) Other relevant patient history, including preexisting medical conditions. (3) Suspect medical product(s). (i) Name; (ii) Dose, frequency, and route of administration used; (iii) Therapy dates; (iv) Diagnosis for use (indication); (v) Whether the product is a combination product as defined in § 3.2(e) of this chapter; (vi) Whether the product is a prescription or nonprescription product; (vii) Whether adverse experience abated after product use stopped or dose reduced; (viii) Whether adverse experience reappeared after reintroduction of the product; (ix) Lot number; (x) Expiration date; (xi) National Drug Code (NDC) number, or other unique identifier; and (xii) Concomitant medical products and therapy dates. (4) Initial reporter information. (i) Name, address, and telephone number; (ii) Whether the initial reporter is a health care professional; and (iii) Occupation, if a health care professional. (5) Applicant information. (i) Applicant name and contact office address; (ii) Telephone number; (iii) Report source, such as spontaneous, literature, or study; (iv) Date the report was received by applicant; (v) Application number and type; (vi) Whether the ICSR is a 15-day “Alert report”; (vii) Whether the ICSR is an initial report or followup report; and (viii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s). (g) Information reported on ICSRs for vaccine products. ICSRs for vaccine products include the following information: (1) Patient information. (i) Patient name, address, telephone number; (ii) Patient age at the time of vaccination, or date of birth; (iii) Patient gender; and (iv) Patient birth weight for children under age 5. (2) Adverse experience. (i) Outcome attributed to adverse experience; (ii) Date and time of adverse experience; (iii) Date of report; (iv) Description of adverse experience (including a concise medical narrative); (v) Adverse experience term(s); (vi) Illness at the time of vaccination; (vii) Description of relevant tests, including dates and laboratory data; and (viii) Other relevant patient history, including preexisting medical conditions. (3) Suspect medical product(s), including vaccines administered on the same date. (i) Name; (ii) Dose, frequency, and route or site of administration used; (iii) Number of previous vaccine doses; (iv) Vaccination date(s) and time(s); (v) Diagnosis for use (indication); (vi) Whether the product is a combination product (as defined in § 3.2(e) of this chapter); (vii) Whether the adverse experience abated after product use stopped or dose reduced; (viii) Whether the adverse experience reappeared after reintroduction of the product; (ix) Lot number; (x) Expiration date; (xi) National Drug Code (NDC) number, or other unique identifier; and (xii) Concomitant medical products and therapy dates. (4) Vaccine(s) administered in the 4 weeks prior to the vaccination date. (i) Name of vaccine; (ii) Manufacturer; (iii) Lot number; (iv) Route or site of administration; (v) Date given; and (vi) Number of previous doses. (5) Initial reporter information. (i) Name, address, and telephone number; (ii) Whether the initial reporter is a health care professional; and (iii) Occupation, if a health care professional. (6) Facility and personnel where vaccine was administered. (i) Name of person who administered vaccine; (ii) Name of responsible physician at facility where vaccine was administered; and (iii) Name, address (including city, county, and state), and telephone number of facility where vaccine was administered. (7) Applicant information. (i) Applicant name and contact office address; (ii) Telephone number; (iii) Report source, such as spontaneous, literature, or study; (iv) Date received by applicant; (v) Application number and type; (vi) Whether the ICSR is a 15-day “Alert report”; (vii) Whether the ICSR is an initial report or followup report; and (viii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s). (h) Electronic format for submissions. (1) Safety report submissions, including ICSRs, ICSR attachments, and the descriptive information in periodic reports, must be in an electronic format that FDA can process, review, and archive. FDA will issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files). (2) Persons subject to the requirements of paragraph (c) of this section may request, in writing, a temporary waiver of the requirements in paragraph (h)(1) of this section. These waivers will be granted on a limited basis for good cause shown. FDA will issue guidance on requesting a waiver of the requirements in paragraph (h)(1) of this section. Requests for waivers must be submitted in accordance with § 600.90. (i) Multiple reports. An applicant should not include in reports under this section any adverse experience that occurred in clinical trials if they were previously submitted as part of the biologics license application. If a report refers to more than one biological product marketed by an applicant, the applicant should submit the report to the biologics license application for the product listed first in the report. (j) Patient privacy. For nonvaccine biological products, an applicant should not include in reports under this section the names and addresses of individual patients; instead, the applicant should assign a unique code for identification of the patient. The applicant should include the name of the reporter from whom the information was received as part of the initial reporter information, even when the reporter is the patient. The names of patients, health care professionals, hospitals, and geographical identifiers in adverse experience reports are not releasable to the public under FDA's public information regulations in part 20 of this chapter. For vaccine adverse experience reports, these data will become part of the CDC Privacy Act System 09-20-0136, “Epidemiologic Studies and Surveillance of Disease Problems.” Information identifying the person who received the vaccine or that person's legal representative will not be made available to the public, but may be available to the vaccinee or legal representative. (k) Recordkeeping. The applicant must maintain for a period of 10 years records of all adverse experiences known to the applicant, including raw data and any correspondence relating to the adverse experiences. (l) Revocation of biologics license. If an applicant fails to establish and maintain records and make reports required under this section with respect to a licensed biological product, FDA may revoke the biologics license for such a product in accordance with the procedures of § 601.5 of this chapter. (m) Exemptions. Manufacturers of the following listed products are not required to submit adverse experience reports under this section: (1) Whole blood or components of whole blood. (2) In vitro diagnostic products, including assay systems for the detection of antibodies or antigens to retroviruses. These products are subject to the reporting requirements for devices. (n) Disclaimer. A report or information submitted by an applicant under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the applicant or FDA that the report or information constitutes an admission that the biological product caused or contributed to an adverse effect. An applicant need not admit, and may deny, that the report or information submitted under this section constitutes an admission that the biological product caused or contributed to an adverse effect. For purposes of this provision, this paragraph also includes any person reporting under paragraph (c)(1)(iii) of this section." 21:21:7.0.1.1.1.4.1.2,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,D,Subpart D—Reporting of Adverse Experiences,,§ 600.81 Distribution reports.,FDA,,,"[59 FR 54042, Oct. 27, 1994, as amended at 64 FR 56449, Oct. 20, 1999; 70 FR 14983, Mar. 24, 2005; 79 FR 33091, June 10, 2014]","(a) Reporting requirements. The applicant must submit to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. The interval between distribution reports must be 6 months. Upon written notice, FDA may require that the applicant submit distribution reports under this section at times other than every 6 months. The distribution report must consist of the bulk lot number (from which the final container was filled), the fill lot numbers for the total number of dosage units of each strength or potency distributed (e.g., fifty thousand per 10-milliliter vials), the label lot number (if different from fill lot number), labeled date of expiration, number of doses in fill lot/label lot, date of release of fill lot/label lot for distribution at that time. If any significant amount of a fill lot/label lot is returned, include this information. Disclosure of financial or pricing data is not required. As needed, FDA may require submission of more detailed product distribution information. Upon written notice, FDA may require that the applicant submit reports under this section at times other than those stated. Requests by an applicant to submit reports at times other than those stated should be made as a request for a waiver under § 600.90. (b)(1) Electronic format. Except as provided for in paragraph (b)(2) of this section, the distribution reports required under paragraph (a) of this section must be submitted to the Agency in an electronic format that FDA can process, review, and archive. FDA will issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files). (2) Waivers. An applicant may request, in writing, a temporary waiver of the requirements in paragraph (b)(1) of this section. These waivers will be granted on a limited basis for good cause shown. FDA will issue guidance on requesting a waiver of the requirements in paragraph (b)(1) of this section. Requests for waivers must be submitted in accordance with § 600.90." 21:21:7.0.1.1.1.4.1.3,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,D,Subpart D—Reporting of Adverse Experiences,,§ 600.82 Notification of a permanent discontinuance or an interruption in manufacturing.,FDA,,,"[80 FR 38939, July 8, 2015]","(a) Notification of a permanent discontinuance or an interruption in manufacturing. (1) An applicant of a biological product, other than blood or blood components for transfusion, which is licensed under section 351 of the Public Health Service Act, and which may be dispensed only under prescription under section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), must notify FDA in writing of a permanent discontinuance of manufacture of the biological product or an interruption in manufacturing of the biological product that is likely to lead to a meaningful disruption in supply of that biological product in the United States if: (i) The biological product is life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such biological product used in emergency medical care or during surgery; and (ii) The biological product is not a radiopharmaceutical biological product. (2) An applicant of blood or blood components for transfusion, which is licensed under section 351 of the Public Health Service Act, and which may be dispensed only under prescription under section 503(b) of the Federal Food, Drug, and Cosmetic Act, must notify FDA in writing of a permanent discontinuance of manufacture of any product listed in its license or an interruption in manufacturing of any such product that is likely to lead to a significant disruption in supply of that product in the United States if: (i) The product is life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such product used in emergency medical care or during surgery; and (ii) The applicant is a manufacturer of a significant percentage of the U.S. blood supply. (b) Submission and timing of notification. Notifications required by paragraph (a) of this section must be submitted to FDA electronically in a format that FDA can process, review, and archive: (1) At least 6 months prior to the date of the permanent discontinuance or interruption in manufacturing; or (2) If 6 months' advance notice is not possible because the permanent discontinuance or interruption in manufacturing was not reasonably anticipated 6 months in advance, as soon as practicable thereafter, but in no case later than 5 business days after such a permanent discontinuance or interruption in manufacturing occurs. (c) Information included in notification. Notifications required by paragraph (a) of this section must include the following information: (1) The name of the biological product subject to the notification, including the National Drug Code for such biological product, or an alternative standard for identification and labeling that has been recognized as acceptable by the Center Director; (2) The name of the applicant of the biological product; (3) Whether the notification relates to a permanent discontinuance of the biological product or an interruption in manufacturing of the biological product; (4) A description of the reason for the permanent discontinuance or interruption in manufacturing; and (5) The estimated duration of the interruption in manufacturing. (d)(1) Public list of biological product shortages. FDA will maintain a publicly available list of biological products that are determined by FDA to be in shortage. This biological product shortages list will include the following information: (i) The names and National Drug Codes for such biological products, or the alternative standards for identification and labeling that have been recognized as acceptable by the Center Director; (ii) The name of each applicant for such biological products; (iii) The reason for the shortage, as determined by FDA, selecting from the following categories: Requirements related to complying with good manufacturing practices; regulatory delay; shortage of an active ingredient; shortage of an inactive ingredient component; discontinuation of the manufacture of the biological product; delay in shipping of the biological product; demand increase for the biological product; or other reason; and (iv) The estimated duration of the shortage. (2) Confidentiality. FDA may choose not to make information collected to implement this paragraph available on the biological product shortages list or available under section 506C(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(c)) if FDA determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the biological product to patients). FDA will also not provide information on the public shortages list or under section 506C(c) of the Federal Food, Drug, and Cosmetic Act that is protected by 18 U.S.C. 1905 or 5 U.S.C. 552(b)(4), including trade secrets and commercial or financial information that is considered confidential or privileged under § 20.61 of this chapter. (e) Noncompliance letters. If an applicant fails to submit a notification as required under paragraph (a) of this section and in accordance with paragraph (b) of this section, FDA will issue a letter to the applicant informing it of such failure. (1) Not later than 30 calendar days after the issuance of such a letter, the applicant must submit to FDA a written response setting forth the basis for noncompliance and providing the required notification under paragraph (a) of this section and including the information required under paragraph (c) of this section; and (2) Not later than 45 calendar days after the issuance of a letter under this paragraph, FDA will make the letter and the applicant's response to the letter public, unless, after review of the applicant's response, FDA determines that the applicant had a reasonable basis for not notifying FDA as required under paragraph (a) of this section. (f) Definitions. The following definitions of terms apply to this section: Biological product shortage or shortage means a period of time when the demand or projected demand for the biological product within the United States exceeds the supply of the biological product. Intended for use in the prevention or treatment of a debilitating disease or condition means a biological product intended for use in the prevention or treatment of a disease or condition associated with mortality or morbidity that has a substantial impact on day-to-day functioning. Life supporting or life sustaining means a biological product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life. Meaningful disruption means a change in production that is reasonably likely to lead to a reduction in the supply of a biological product by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product, and does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. Significant disruption means a change in production that is reasonably likely to lead to a reduction in the supply of blood or blood components by a manufacturer that substantially affects the ability of the manufacturer to fill orders or meet expected demand for its product, and does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time." 21:21:7.0.1.1.1.4.1.4,21,Food and Drugs,I,F,600,PART 600—BIOLOGICAL PRODUCTS: GENERAL,D,Subpart D—Reporting of Adverse Experiences,,§ 600.90 Waivers.,FDA,,,"[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]","(a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following: (1) An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved, (2) A description of an alternative submission that satisfies the purpose of the requirement, or (3) Other information justifying a waiver. (b) FDA may grant a waiver if it finds one of the following: (1) The applicant's compliance with the requirement is unnecessary or cannot be achieved, (2) The applicant's alternative submission satisfies the requirement, or (3) The applicant's submission otherwise justifies a waiver." 28:28:2.0.4.5.1.0.127.1,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.1 Grounds for appointing a Special Counsel.,,,,,"The Attorney General, or in cases in which the Attorney General is recused, the Acting Attorney General, will appoint a Special Counsel when he or she determines that criminal investigation of a person or matter is warranted and— (a) That investigation or prosecution of that person or matter by a United States Attorney's Office or litigating Division of the Department of Justice would present a conflict of interest for the Department or other extraordinary circumstances; and (b) That under the circumstances, it would be in the public interest to appoint an outside Special Counsel to assume responsibility for the matter." 28:28:2.0.4.5.1.0.127.10,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.10 No creation of rights.,,,,,"The regulations in this part are not intended to, do not, and may not be relied upon to create any rights, substantive or procedural, enforceable at law or equity, by any person or entity, in any matter, civil, criminal, or administrative." 28:28:2.0.4.5.1.0.127.2,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.2 Alternatives available to the Attorney General.,,,,,"When matters are brought to the attention of the Attorney General that might warrant consideration of appointment of a Special Counsel, the Attorney General may: (a) Appoint a Special Counsel; (b) Direct that an initial investigation, consisting of such factual inquiry or legal research as the Attorney General deems appropriate, be conducted in order to better inform the decision; or (c) Conclude that under the circumstances of the matter, the public interest would not be served by removing the investigation from the normal processes of the Department, and that the appropriate component of the Department should handle the matter. If the Attorney General reaches this conclusion, he or she may direct that appropriate steps be taken to mitigate any conflicts of interest, such as recusal of particular officials." 28:28:2.0.4.5.1.0.127.3,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.3 Qualifications of the Special Counsel.,,,,,"(a) An individual named as Special Counsel shall be a lawyer with a reputation for integrity and impartial decisionmaking, and with appropriate experience to ensure both that the investigation will be conducted ably, expeditiously and thoroughly, and that investigative and prosecutorial decisions will be supported by an informed understanding of the criminal law and Department of Justice policies. The Special Counsel shall be selected from outside the United States Government. Special Counsels shall agree that their responsibilities as Special Counsel shall take first precedence in their professional lives, and that it may be necessary to devote their full time to the investigation, depending on its complexity and the stage of the investigation. (b) The Attorney General shall consult with the Assistant Attorney General for Administration to ensure an appropriate method of appointment, and to ensure that a Special Counsel undergoes an appropriate background investigation and a detailed review of ethics and conflicts of interest issues. A Special Counsel shall be appointed as a “confidential employee” as defined in 5 U.S.C. 7511(b)(2)(C)." 28:28:2.0.4.5.1.0.127.4,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.4 Jurisdiction.,,,,,"(a) Original jurisdiction. The jurisdiction of a Special Counsel shall be established by the Attorney General. The Special Counsel will be provided with a specific factual statement of the matter to be investigated. The jurisdiction of a Special Counsel shall also include the authority to investigate and prosecute federal crimes committed in the course of, and with intent to interfere with, the Special Counsel's investigation, such as perjury, obstruction of justice, destruction of evidence, and intimidation of witnesses; and to conduct appeals arising out of the matter being investigated and/or prosecuted. (b) Additional jurisdiction. If in the course of his or her investigation the Special Counsel concludes that additional jurisdiction beyond that specified in his or her original jurisdiction is necessary in order to fully investigate and resolve the matters assigned, or to investigate new matters that come to light in the course of his or her investigation, he or she shall consult with the Attorney General, who will determine whether to include the additional matters within the Special Counsel's jurisdiction or assign them elsewhere. (c) Civil and administrative jurisdiction. If in the course of his or her investigation the Special Counsel determines that administrative remedies, civil sanctions or other governmental action outside the criminal justice system might be appropriate, he or she shall consult with the Attorney General with respect to the appropriate component to take any necessary action. A Special Counsel shall not have civil or administrative authority unless specifically granted such jurisdiction by the Attorney General." 28:28:2.0.4.5.1.0.127.5,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.5 Staff.,,,,,"A Special Counsel may request the assignment of appropriate Department employees to assist the Special Counsel. The Department shall gather and provide the Special Counsel with the names and resumes of appropriate personnel available for detail. The Special Counsel may also request the detail of specific employees, and the office for which the designated employee works shall make reasonable efforts to accommodate the request. The Special Counsel shall assign the duties and supervise the work of such employees while they are assigned to the Special Counsel. If necessary, the Special Counsel may request that additional personnel be hired or assigned from outside the Department. All personnel in the Department shall cooperate to the fullest extent possible with the Special Counsel." 28:28:2.0.4.5.1.0.127.6,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.6 Powers and authority.,,,,,"Subject to the limitations in the following paragraphs, the Special Counsel shall exercise, within the scope of his or her jurisdiction, the full power and independent authority to exercise all investigative and prosecutorial functions of any United States Attorney. Except as provided in this part, the Special Counsel shall determine whether and to what extent to inform or consult with the Attorney General or others within the Department about the conduct of his or her duties and responsibilities." 28:28:2.0.4.5.1.0.127.7,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.7 Conduct and accountability.,,,,,"(a) A Special Counsel shall comply with the rules, regulations, procedures, practices and policies of the Department of Justice. He or she shall consult with appropriate offices within the Department for guidance with respect to established practices, policies and procedures of the Department, including ethics and security regulations and procedures. Should the Special Counsel conclude that the extraordinary circumstances of any particular decision would render compliance with required review and approval procedures by the designated Departmental component inappropriate, he or she may consult directly with the Attorney General. (b) The Special Counsel shall not be subject to the day-to-day supervision of any official of the Department. However, the Attorney General may request that the Special Counsel provide an explanation for any investigative or prosecutorial step, and may after review conclude that the action is so inappropriate or unwarranted under established Departmental practices that it should not be pursued. In conducting that review, the Attorney General will give great weight to the views of the Special Counsel. If the Attorney General concludes that a proposed action by a Special Counsel should not be pursued, the Attorney General shall notify Congress as specified in § 600.9(a)(3). (c) The Special Counsel and staff shall be subject to disciplinary action for misconduct and breach of ethical duties under the same standards and to the same extent as are other employees of the Department of Justice. Inquiries into such matters shall be handled through the appropriate office of the Department upon the approval of the Attorney General. (d) The Special Counsel may be disciplined or removed from office only by the personal action of the Attorney General. The Attorney General may remove a Special Counsel for misconduct, dereliction of duty, incapacity, conflict of interest, or for other good cause, including violation of Departmental policies. The Attorney General shall inform the Special Counsel in writing of the specific reason for his or her removal." 28:28:2.0.4.5.1.0.127.8,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.8 Notification and reports by the Special Counsel.,,,,,"(a) Budget. (1) A Special Counsel shall be provided all appropriate resources by the Department of Justice. Within the first 60 days of his or her appointment, the Special Counsel shall develop a proposed budget for the current fiscal year with the assistance of the Justice Management Division for the Attorney General's review and approval. Based on the proposal, the Attorney General shall establish a budget for the operations of the Special Counsel. The budget shall include a request for assignment of personnel, with a description of the qualifications needed. (2) Thereafter, 90 days before the beginning of each fiscal year, the Special Counsel shall report to the Attorney General the status of the investigation, and provide a budget request for the following year. The Attorney General shall determine whether the investigation should continue and, if so, establish the budget for the next year. (b) Notification of significant events. The Special Counsel shall notify the Attorney General of events in the course of his or her investigation in conformity with the Departmental guidelines with respect to Urgent Reports. (c) Closing documentation. At the conclusion of the Special Counsel's work, he or she shall provide the Attorney General with a confidential report explaining the prosecution or declination decisions reached by the Special Counsel." 28:28:2.0.4.5.1.0.127.9,28,Judicial Administration,VI,,600,PART 600—GENERAL POWERS OF SPECIAL COUNSEL,,,,§ 600.9 Notification and reports by the Attorney General.,,,,,"(a) The Attorney General will notify the Chairman and Ranking Minority Member of the Judiciary Committees of each House of Congress, with an explanation for each action— (1) Upon appointing a Special Counsel; (2) Upon removing any Special Counsel; and (3) Upon conclusion of the Special Counsels investigation, including, to the extent consistent with applicable law, a description and explanation of instances (if any) in which the Attorney General concluded that a proposed action by a Special Counsel was so inappropriate or unwarranted under established Departmental practices that it should not be pursued. (b) The notification requirement in paragraph (a)(1) of this section may be tolled by the Attorney General upon a finding that legitimate investigative or privacy concerns require confidentiality. At such time as confidentiality is no longer needed, the notification will be provided. (c) The Attorney General may determine that public release of these reports would be in the public interest, to the extent that release would comply with applicable legal restrictions. All other releases of information by any Department of Justice employee, including the Special Counsel and staff, concerning matters handled by Special Counsels shall be governed by the generally applicable Departmental guidelines concerning public comment with respect to any criminal investigation, and relevant law." 34:34:3.1.3.1.1.1.1.1,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.1 Scope.,ED,,,,"This part establishes the rules and procedures that the Secretary uses to determine whether an educational institution qualifies in whole or in part as an eligible institution of higher education under the Higher Education Act of 1965, as amended (HEA). An eligible institution of higher education may apply to participate in programs authorized by the HEA (HEA programs)." 34:34:3.1.3.1.1.1.1.10,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,"§ 600.10 Date, extent, duration, and consequence of eligibility.",ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 59 FR 47801, Sept. 19, 1994; 65 FR 65671, Nov. 1, 2000; 71 FR 45692, Aug. 9, 2006; 75 FR 66676, Oct. 29, 2010; 79 FR 65006, Oct. 31, 2014; 84 FR 31452, July 1, 2019; 85 FR 54810, Sept. 2, 2020; 87 FR 63691, Oct. 20, 2022; 87 FR 65487, Oct. 28, 2022; 88 FR 70185, Oct. 10, 2023]","(a) Date of eligibility. (1) If the Secretary determines that an applicant institution satisfies all the statutory and regulatory eligibility requirements, the Secretary considers the institution to be an eligible institution as of the date— (i) The Secretary signs the institution's program participation agreement described in 34 CFR part 668, subpart B, for purposes of participating in any title IV, HEA program; and (ii) The Secretary receives all the information necessary to make that determination for purposes other than participating in any title IV, HEA program. (2) [Reserved] (b) Extent of eligibility. (1) If the Secretary determines that the entire applicant institution, including all its locations and all its educational programs, satisfies the applicable requirements of this part, the Secretary extends eligibility to all educational programs and locations identified on the institution's application for eligibility. (2) If the Secretary determines that only certain educational programs or certain locations of an applicant institution satisfy the applicable requirements of this part, the Secretary extends eligibility only to those educational programs and locations that meet those requirements and identifies the eligible educational programs and locations in the eligibility notice sent to the institution under § 600.21. (3) Eligibility does not extend to any location that an institution establishes after it receives its eligibility designation if the institution provides at least 50 percent of an educational program at that location, unless— (i) The Secretary approves that location under § 600.20(e)(4); or (ii) The location is licensed and accredited, the institution does not have to apply to the Secretary for approval of that location under § 600.20(c), and the institution has reported to the Secretary that location under § 600.21. (c) Educational programs. (1) An eligible institution that seeks to establish the eligibility of an educational program must obtain the Secretary's approval— (i) Pursuant to a requirement regarding additional programs included in the institution's Program Participation Agreement (PPA) under 34 CFR 668.14; (ii) For the first direct assessment program under 34 CFR 668.10, the first direct assessment program offered at each credential level, and for a comprehensive transition and postsecondary program under 34 CFR 668.232; (iii) For an undergraduate program that is at least 300 clock hours but less than 600 clock hours and does not admit as regular students only persons who have completed the equivalent of an associate degree under 34 CFR 668.8(d)(3); and (iv) For the first eligible prison education program under subpart P of 34 CFR part 668 offered at the first two additional locations as defined under § 600.2 at a Federal, State, or local penitentiary, prison, jail, reformatory, work farm, juvenile justice facility, or other similar correctional institution. (2) Except as provided under § 600.20(c), an eligible institution does not have to obtain the Secretary's approval to establish the eligibility of any program that is not described in paragraph (c)(1) of this section. (3) For a gainful employment program under 34 CFR part 668, subpart S, subject to any restrictions in 34 CFR 668.603 on establishing or reestablishing the eligibility of the program, an eligible institution must update its application under § 600.21. (4) An institution must repay to the Secretary all HEA program funds received by the institution for an educational program, and all the title IV, HEA program funds received by or on behalf of students who enrolled in that program if the institution— (i) Fails to comply with the requirements in paragraph (c)(1) of this section; or (ii) Incorrectly determines that an educational program that is not subject to approval under paragraph (c)(1) of this section is an eligible program for title IV, HEA program purposes. (d) Duration of eligibility. (1) If an institution participates in the title IV, HEA programs, the Secretary's designation of the institution as an eligible institution under the title IV, HEA programs expires when the institution's program participation agreement, as described in 34 CFR part 668, subpart B, expires. (2) If an institution participates in an HEA program other than a title IV, HEA program, the Secretary's designation of the institution as an eligible institution, for purposes of that non-title IV, HEA program, does not expire as long as the institution continues to satisfy the statutory and regulatory requirements governing its eligibility. (e) Consequence of eligibility. (1) If, as a part of its institutional eligibility application, an institution indicates that it wishes to participate in a title IV, HEA program and the Secretary determines that the institution satisfies the applicable statutory and regulatory requirements governing institutional eligibility, the Secretary will determine whether the institution satisfies the standards of administrative capability and financial responsibility contained in 34 CFR part 668, subpart B. (2) If, as part of its institutional eligibility application, an institution indicates that it does not wish to participate in any title IV, HEA program and the Secretary determines that the institution satisfies the applicable statutory and regulatory requirements governing institutional eligibility, the institution is eligible to apply to participate in any HEA program listed by the Secretary in the eligibility notice it receives under § 600.21. However, the institution is not eligible to participate in those programs, or receive funds under those programs, merely by virtue of its designation as an eligible institution under this part." 34:34:3.1.3.1.1.1.1.11,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.11 Special rules regarding institutional accreditation or preaccreditation.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 85 FR 58916, Nov.1, 2019]","(a) Change of accrediting agencies. (1) For purposes of §§ 600.4(a)(5)(i), 600.5(a)(6), and 600.6(a)(5)(i), the Secretary does not recognize the accreditation or preaccreditation of an otherwise eligible institution if that institution is in the process of changing its accrediting agency, unless the institution provides the following to the Secretary and receives approval: (i) All materials related to its prior accreditation or preaccreditation. (ii) Materials demonstrating reasonable cause for changing its accrediting agency. The Secretary will not determine such cause to be reasonable if the institution— (A) Has had its accreditation withdrawn, revoked, or otherwise terminated for cause during the preceding 24 months, unless such withdrawal, revocation, or termination has been rescinded by the same accrediting agency; or (B) Has been subject to a probation or equivalent, show cause order, or suspension order during the preceding 24 months. (2) Notwithstanding paragraph (a)(1)(ii) of this section, the Secretary may determine the institution's cause for changing its accrediting agency to be reasonable if the agency did not provide the institution its due process rights as defined in § 602.25, the agency applied its standards and criteria inconsistently, or if the adverse action or show cause or suspension order was the result of an agency's failure to respect an institution's stated mission, including religious mission. (b) Multiple accreditation. The Secretary does not recognize the accreditation or preaccreditation of an otherwise eligible institution if that institution is accredited or preaccredited as an institution by more than one accrediting agency, unless the institution— (1) Provides to each such accrediting agency and the Secretary the reasons for that multiple accreditation or preaccreditation; (2) Demonstrates to the Secretary reasonable cause for that multiple accreditation or preaccreditation. (i) The Secretary determines the institution's cause for multiple accreditation to be reasonable unless the institution— (A) Has had its accreditation withdrawn, revoked, or otherwise terminated for cause during the preceding 24 months, unless such withdrawal, revocation, or termination has been rescinded by the same accrediting agency; or (B) Has been subject to a probation or equivalent, show cause order, or suspension order during the preceding 24 months. (ii) Notwithstanding paragraphs (b)(2)(i)(A) and (B) of this section, the Secretary may determine the institution's cause for seeking multiple accreditation or preaccreditation to be reasonable if the institution's primary interest in seeking multiple accreditation is based on that agency's geographic area, program-area focus, or mission; and (3) Designates to the Secretary which agency's accreditation or preaccreditation the institution uses to establish its eligibility under this part. (c) Loss of accreditation or preaccreditation. (1) An institution may not be considered eligible for 24 months after it has had its accreditation or preaccreditation withdrawn, revoked, or otherwise terminated for cause, unless the accrediting agency that took that action rescinds that action. (2) An institution may not be considered eligible for 24 months after it has withdrawn voluntarily from its accreditation or preaccreditation status under a show-cause or suspension order issued by an accrediting agency, unless that agency rescinds its order. (d) Religious exception. (1) If an otherwise eligible institution loses its accreditation or preaccreditation, the Secretary considers the institution to be accredited or preaccredited for purposes of complying with the provisions of §§ 600.4, 600.5, and 600.6 if the Secretary determines that its loss of accreditation or preaccreditation— (i) Is related to the religious mission or affiliation of the institution; and (ii) Is not related to its failure to satisfy the accrediting agency's standards. (2) If the Secretary considers an unaccredited institution to be accredited or preaccredited under the provisions of paragraph (d)(1) of this section, the Secretary will consider that unaccredited institution to be accredited or preaccredited for a period sufficient to allow the institution to obtain alternative accreditation or preaccreditation, except that period may not exceed 18 months." 34:34:3.1.3.1.1.1.1.12,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.12 Severability.,ED,,,"[84 FR 58916, Nov. 1, 2019]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:3.1.3.1.1.1.1.2,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.2 Definitions.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 63 FR 40622, July 29, 1998; 64 FR 58615, Oct. 29, 1999; 71 FR 45692, Aug. 9, 2006; 74 FR 55425, Oct. 27, 2009; 74 FR 55932, Oct. 29, 2009; 75 FR 66946, Oct. 29, 2010, 75 FR 67192, Nov. 1, 2010; 79 FR 65006, Oct. 31, 2014; 81 FR 92262, Dec. 19, 2016; 84 FR 58914, Nov. 1, 2019' 85 FR 54808, Sept. 2, 2020; 87 FR 65485, Oct. 28, 2022]","The following definitions apply to terms used in this part: Academic engagement: Active participation by a student in an instructional activity related to the student's course of study that— (1) Is defined by the institution in accordance with any applicable requirements of its State or accrediting agency; (2) Includes, but is not limited to— (i) Attending a synchronous class, lecture, recitation, or field or laboratory activity, physically or online, where there is an opportunity for interaction between the instructor and students; (ii) Submitting an academic assignment; (iii) Taking an assessment or an exam; (iv) Participating in an interactive tutorial, webinar, or other interactive computer-assisted instruction; (v) Participating in a study group, group project, or an online discussion that is assigned by the institution; or (vi) Interacting with an instructor about academic matters; and (3) Does not include, for example— (i) Living in institutional housing; (ii) Participating in the institution's meal plan; (iii) Logging into an online class or tutorial without any further participation; or (iv) Participating in academic counseling or advisement. Accredited: The status of public recognition that a nationally recognized accrediting agency grants to an institution or educational program that meets the agency's established requirements. Additional location: (1) A physical facility that is geographically separate from the main campus of the institution and within the same ownership structure of the institution, at which the institution offers at least 50 percent of an educational program. An additional location participates in the title IV, HEA programs only through the certification of the main campus. (2) A Federal, State, or local penitentiary, prison, jail, reformatory, work farm, juvenile justice facility, or other similar correctional institution is considered to be an additional location even if a student receives instruction primarily through distance education or correspondence courses at that location. Award year: The period of time from July 1 of one year through June 30 of the following year. Branch campus: A physical facility that is geographically separate from the main campus of the institution and within the same ownership structure of the institution, and that also— (1) Is approved by the Secretary as a branch campus; and (2) Is independent from the main campus, meaning the location— (i) Is permanent in nature; (ii) Offers courses in educational programs leading to a degree, certificate, or other recognized education credential; (iii) Has its own faculty and administrative or supervisory organization; and (iv) Has its own budgetary and hiring authority. Clock hour: (1) A period of time consisting of— (i) A 50- to 60-minute class, lecture, or recitation in a 60-minute period; (ii) A 50- to 60-minute faculty-supervised laboratory, shop training, or internship in a 60-minute period; (iii) Sixty minutes of preparation in a correspondence course; or (iv) In distance education, 50 to 60 minutes in a 60-minute period of attendance in— (A) A synchronous or asynchronous class, lecture, or recitation where there is opportunity for direct interaction between the instructor and students; or (B) An asynchronous learning activity involving academic engagement in which the student interacts with technology that can monitor and document the amount of time that the student participates in the activity. (2) A clock hour in a distance education program does not meet the requirements of this definition if it does not meet all accrediting agency and State requirements or if it exceeds an agency's or State's restrictions on the number of clock hours in a program that may be offered through distance education. (3) An institution must be capable of monitoring a student's attendance in 50 out of 60 minutes for each clock hour under this definition. Confined or incarcerated individual: An individual who is serving a criminal sentence in a Federal, State, or local penitentiary, prison, jail, reformatory, work farm, juvenile justice facility, or other similar correctional institution. An individual is not considered incarcerated if that individual is subject to or serving an involuntary civil commitment, in a half-way house or home detention, or is sentenced to serve only weekends. Correspondence course: (1) A course provided by an institution under which the institution provides instructional materials, by mail or electronic transmission, including examinations on the materials, to students who are separated from the instructors. Interaction between instructors and students in a correspondence course is limited, is not regular and substantive, and is primarily initiated by the student. (2) If a course is part correspondence and part residential training, the Secretary considers the course to be a correspondence course. (3) A correspondence course is not distance education. Credit hour: Except as provided in 34 CFR 668.8(k) and (l), a credit hour is an amount of student work defined by an institution, as approved by the institution's accrediting agency or State approval agency, that is consistent with commonly accepted practice in postsecondary education and that— (1) Reasonably approximates not less than— (i) One hour of classroom or direct faculty instruction and a minimum of two hours of out-of-class student work each week for approximately fifteen weeks for one semester or trimester hour of credit, or ten to twelve weeks for one quarter hour of credit, or the equivalent amount of work over a different period of time; or (ii) At least an equivalent amount of work as required in paragraph (1)(i) of this definition for other academic activities as established by the institution, including laboratory work, internships, practica, studio work, and other academic work leading to the award of credit hours; and (2) Permits an institution, in determining the amount of work associated with a credit hour, to take into account a variety of delivery methods, measurements of student work, academic calendars, disciplines, and degree levels. Distance education: (1) Education that uses one or more of the technologies listed in paragraphs (2)(i) through (iv) of this definition to deliver instruction to students who are separated from the instructor or instructors and to support regular and substantive interaction between the students and the instructor or instructors, either synchronously or asynchronously. (2) The technologies that may be used to offer distance education include— (i) The internet; (ii) One-way and two-way transmissions through open broadcast, closed circuit, cable, microwave, broadband lines, fiber optics, satellite, or wireless communications devices; (iii) Audio conference; or (iv) Other media used in a course in conjunction with any of the technologies listed in paragraphs (2)(i) through (iii) of this definition. (3) For purposes of this definition, an instructor is an individual responsible for delivering course content and who meets the qualifications for instruction established by an institution's accrediting agency. (4) For purposes of this definition, substantive interaction is engaging students in teaching, learning, and assessment, consistent with the content under discussion, and also includes at least two of the following— (i) Providing direct instruction; (ii) Assessing or providing feedback on a student's coursework; (iii) Providing information or responding to questions about the content of a course or competency; (iv) Facilitating a group discussion regarding the content of a course or competency; or (v) Other instructional activities approved by the institution's or program's accrediting agency. (5) An institution ensures regular interaction between a student and an instructor or instructors by, prior to the student's completion of a course or competency— (i) Providing the opportunity for substantive interactions with the student on a predictable and scheduled basis commensurate with the length of time and the amount of content in the course or competency; and (ii) Monitoring the student's academic engagement and success and ensuring that an instructor is responsible for promptly and proactively engaging in substantive interaction with the student when needed on the basis of such monitoring, or upon request by the student. Educational program: (1) A legally authorized postsecondary program of organized instruction or study that: (i) Leads to an academic, professional, or vocational degree, or certificate, or other recognized educational credential, or is a comprehensive transition and postsecondary program, as described in 34 CFR part 668, subpart O; and (ii) May, in lieu of credit hours or clock hours as a measure of student learning, utilize direct assessment of student learning, or recognize the direct assessment of student learning by others, if such assessment is consistent with the accreditation of the institution or program utilizing the results of the assessment and with the provisions of § 668.10. (2) The Secretary does not consider that an institution provides an educational program if the institution does not provide instruction itself (including a course of independent study) but merely gives credit for one or more of the following: Instruction provided by other institutions or schools; examinations or direct assessments provided by agencies or organizations; or other accomplishments such as “life experience.” Eligible institution: An institution that— (1) Qualifies as— (i) An institution of higher education, as defined in § 600.4; (ii) A proprietary institution of higher education, as defined in § 600.5; or (iii) A postsecondary vocational institution, as defined in § 600.6; and (2) Meets all the other applicable provisions of this part. Federal Family Education Loan (FFEL) Programs: The loan programs (formerly called the Guaranteed Student Loan (GSL) programs) authorized by title IV-B of the HEA, including the Federal Stafford Loan, Federal PLUS, Federal Supplemental Loans for Students (Federal SLS), and Federal Consolidation Loan programs, in which lenders use their own funds to make loans to enable students or their parents to pay the costs of the students' attendance at eligible institutions. The Federal Stafford Loan, Federal PLUS, Federal SLS, and Federal Consolidation Loan programs are defined in 34 CFR part 668. Juvenile justice facility: A public or private residential facility that is operated primarily for the care and rehabilitation of youth who, under State juvenile justice laws— (1) Are accused of committing a delinquent act; (2) Have been adjudicated delinquent; or (3) Are determined to be in need of supervision. Main campus: The primary physical facility at which the institution offers eligible programs, within the same ownership structure of the institution, and certified as the main campus by the Department and the institution's accrediting agency. Nationally recognized accrediting agency: An agency or association that the Secretary recognizes as a reliable authority to determine the quality of education or training offered by an institution or a program offered by an institution. The Secretary recognizes these agencies and associations under the provisions of 34 CFR part 602 and publishes a list of the recognized agencies in the Federal Register. Nonprofit institution: (1) A nonprofit institution is a domestic public or private institution or foreign institution as to which the Secretary determines that no part of the net earnings of the institution benefits any private entity or natural person and that meets the requirements of paragraphs (2) through (4) of this definition, as applicable. (2) When making the determination under paragraph (1) of this definition, the Secretary considers the entirety of the relationship between the institution, the entities in its ownership structure, and other parties. For example, a nonprofit institution is generally not an institution that— (i) Is an obligor (either directly or through any entity in its ownership chain) on a debt owed to a former owner of the institution or a natural person or entity related to or affiliated with the former owner of the institution; (ii) Either directly or through any entity in its ownership chain, enters into or maintains a revenue-sharing agreement, unless the Secretary determines that the payments and the terms under the revenue-sharing agreement are reasonable, based on the market price and terms for such services or materials, and the price bears a reasonable relationship to the cost of the services or materials provided, with— (A) A former owner or current or former employee of the institution or member of its board; or (B) A natural person or entity related to or affiliated with the former owner or current or former employee of the institution or member of its board; (iii) Is a party (either directly or indirectly) to any other agreements (including lease agreements) under which the institution is obligated to make any payments, unless the Secretary determines that the payments and terms under the agreement are comparable to payments in an arm's-length transaction at fair market value, with— (A) A former owner or current or former employee of the institution or member of its board; or (B) A natural person or entity related to or affiliated with the former owner or current or former employee of the institution or member of its board; or (iv) Engages in an excess benefit transaction with any natural person or entity. (3) A private institution is a “nonprofit institution” only if it meets the requirements in paragraph (1) of this definition and is— (i) Owned and operated by one or more nonprofit corporations or associations; (ii) Legally authorized to operate as a nonprofit organization by each State in which it is physically located; and (iii) Determined by the U.S. Internal Revenue Service to be an organization described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)). (4) A foreign institution is a “nonprofit institution” only if it meets the requirements in paragraph (1) of this definition and is— (i) An institution that is owned and operated only by one or more nonprofit corporations or associations; and (ii)(A) If a recognized tax authority of the institution's home country is recognized by the Secretary for purposes of making determinations of an institution's nonprofit status for title IV purposes, is determined by that tax authority to be a nonprofit educational institution; or (B) If no recognized tax authority of the institution's home country is recognized by the Secretary for purposes of making determinations of an institution's nonprofit status for title IV purposes, the foreign institution demonstrates to the satisfaction of the Secretary that it is a nonprofit educational institution. One-academic-year training program: An educational program that is at least one academic year as defined under 34 CFR 668.2. Preaccreditation: The status of accreditation and public recognition that a nationally recognized accrediting agency grants to an institution or program for a limited period of time that signifies the agency has determined that the institution or program is progressing toward full accreditation and is likely to attain full accreditation before the expiration of that limited period of time (sometimes referred to as “candidacy”). Recognized equivalent of a high school diploma: The following are the equivalent of a high school diploma— (1) A General Education Development Certificate (GED); (2) A State certificate received by a student after the student has passed a State-authorized examination that the State recognizes as the equivalent of a high school diploma; (3) An academic transcript of a student who has successfully completed at least a two-year program that is acceptable for full credit toward a bachelor's degree; or (4) For a person who is seeking enrollment in an educational program that leads to at least an associate degree or its equivalent and who has not completed high school but who excelled academically in high school, documentation that the student excelled academically in high school and has met the formalized, written policies of the institution for admitting such students. Recognized occupation: An occupation that is— (1) Identified by a Standard Occupational Classification (SOC) code established by the Office of Management and Budget (OMB) or an Occupational Information Network O*Net-SOC code established by the Department of Labor, which is available at www.onetonline.org or its successor site; or (2) Determined by the Secretary in consultation with the Secretary of Labor to be a recognized occupation. Regular student: A person who is enrolled or accepted for enrollment at an institution for the purpose of obtaining a degree, certificate, or other recognized educational credential offered by that institution. Religious mission: A published institutional mission that is approved by the governing body of an institution of postsecondary education and that includes, refers to, or is predicated upon religious tenets, beliefs, or teachings. Secretary: The Secretary of the Department of Education or an official or employee of the Department of Education acting for the Secretary under a delegation of authority. State: A State of the Union, American Samoa, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau. The latter three are also known as the Freely Associated States. State authorization reciprocity agreement: An agreement between two or more States that authorizes an institution located and legally authorized in a State covered by the agreement to provide postsecondary education through distance education or correspondence courses to students located in other States covered by the agreement and cannot prohibit any member State of the agreement from enforcing its own general-purpose State laws and regulations outside of the State authorization of distance education. Teach-out: A process during which a program, institution, or institutional location that provides 100 percent of at least one program engages in an orderly closure or when, following the closure of an institution or campus, another institution provides an opportunity for the students of the closed school to complete their program, regardless of their academic progress at the time of closure. Teach-out agreement: A written agreement between institutions that provides for the equitable treatment of students and a reasonable opportunity for students to complete their program of study if an institution, or an institutional location that provides 100 percent of at least one program offered, ceases to operate or plans to cease operations before all enrolled students have completed their program of study. Teach-out plan: A written plan developed by an institution that provides for the equitable treatment of students if an institution, or an institutional location that provides 100 percent of at least one program, ceases to operate or plans to cease operations before all enrolled students have completed their program of study. Title IV, HEA program: Any of the student financial assistance programs listed in 34 CFR 668.1(c)." 34:34:3.1.3.1.1.1.1.3,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.3 [Reserved],ED,,,, 34:34:3.1.3.1.1.1.1.4,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.4 Institution of higher education.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 64 FR 58615, Oct. 29, 1999; 74 FR 55932, Oct. 29, 2009; 75 FR 66946, Oct. 29, 2010; 84 FR 58915, Nov. 1, 2019; 87 FR 65486, Oct. 28, 2022]","(a) An institution of higher education is a public or other nonprofit educational institution that— (1) Is in a State, or for purposes of the Federal Pell Grant, Federal Supplemental Educational Opportunity Grant, Federal Work-Study, and Federal TRIO programs may also be located in the Federated States of Micronesia or the Marshall Islands; (2) Admits as regular students only persons who— (i) Have a high school diploma; (ii) Have the recognized equivalent of a high school diploma; or (iii) Are beyond the age of compulsory school attendance in the State in which the institution is physically located; (3) Is legally authorized to provide an educational program beyond secondary education in the State in which the institution is physically located in accordance with § 600.9; (4)(i) Provides an educational program— (A) For which it awards an associate, baccalaureate, graduate, or professional degree; (B) That is at least a two-academic-year program acceptable for full credit toward a baccalaureate degree; or (C) That is at least a one academic year training program that leads to a certificate, or other nondegree recognized credential, and prepares students for gainful employment in a recognized occupation; and (ii) May provide a comprehensive transition and postsecondary program, as described in 34 CFR part 668, subpart O; and (5) Is— (i) Accredited or preaccredited; or (ii) Approved by a State agency listed in the Federal Register in accordance with 34 CFR part 603, if the institution is a public postsecondary vocational educational institution that seeks to participate only in Federal student assistance programs. (b) An institution is physically located in a State if it has a campus or other instructional site in that State. (c) The Secretary does not recognize the accreditation or preaccreditation of an institution unless the institution agrees to submit any dispute involving an adverse action, such as the final denial, withdrawal, or termination of accreditation, to arbitration before initiating any other legal action." 34:34:3.1.3.1.1.1.1.5,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.5 Proprietary institution of higher education.,ED,,,"[59 FR 22336, Apr. 29, 1994; 59 FR 32082, June 22, 1994, as amended at 59 FR 47801, Sept. 19, 1994; 59 FR 61177, Nov. 29, 1994; 61 FR 29901, June 12, 1996; 61 FR 60569, Nov. 29, 1996; 64 FR 58615, Oct. 29, 1999; 74 FR 55932, Oct. 29, 2009; 76 FR 66946, Oct. 29, 2010; 84 FR 58915, Nov. 1, 2019]","(a) A proprietary institution of higher education is an educational institution that— (1) Is not a public or private nonprofit educational institution; (2) Is in a State; (3) Admits as regular students only persons who— (i) Have a high school diploma; (ii) Have the recognized equivalent of a high school diploma; or (iii) Are beyond the age of compulsory school attendance in the State in which the institution is physically located; (4) Is legally authorized to provide an educational program beyond secondary education in the State in which the institution is physically located in accordance with § 600.9; (5)(i)(A) Provides an eligible program of training, as defined in 34 CFR 668.8, to prepare students for gainful employment in a recognized occupation; or (B)( 1 ) Has provided a program leading to a baccalaureate degree in liberal arts, as defined in paragraph (e) of this section, continuously since January 1, 2009; and ( 2 ) Is accredited by a recognized regional accrediting agency or association, and has continuously held such accreditation since October 1, 2007, or earlier; and (ii) May provide a comprehensive transition and postsecondary program for students with intellectual disabilities, as provided in 34 CFR part 668, subpart O; (6) Is accredited; and (7) Has been in existence for at least two years. (b)(1) The Secretary considers an institution to have been in existence for two years only if— (i) The institution has been legally authorized to provide, and has provided, a continuous educational program to prepare students for gainful employment in a recognized occupation during the 24 months preceding the date of its eligibility application; and (ii) The educational program that the institution provides on the date of its eligibility application is substantially the same in length and subject matter as the program that the institution provided during the 24 months preceding the date of its eligibility application. (2)(i) The Secretary considers an institution to have provided a continuous educational program during the 24 months preceding the date of its eligibility application even if the institution did not provide that program during normal vacation periods, or periods when the institution temporarily closed due to a natural disaster that directly affected the institution or the institution's students. (ii) The Secretary considers an institution to have satisfied the provisions of paragraph (b)(1)(ii) of this section if the institution substantially changed the subject matter of the educational program it provided during that 24-month period because of new technology or the requirements of other Federal agencies. (3) In determining whether an applicant institution satisfies the requirement contained in paragraph (b)(1) of this section, the Secretary— (i) Counts any period during which the applicant institution has been certified as a branch campus; and (ii) Except as provided in paragraph (b)(3)(i) of this section, does not count any period during which the applicant institution was a part of another eligible proprietary institution of higher education, postsecondary vocational institution, or vocational school. (c) An institution is physically located in a State if it has a campus or other instructional site in that State. (d) The Secretary does not recognize the accreditation of an institution unless the institution agrees to submit any dispute involving an adverse action, such as the final denial, withdrawal, or termination of accreditation, to arbitration before initiating any other legal action. (e) For purposes of this section, a “program leading to a baccalaureate degree in liberal arts” is a program that is a general instructional program falling within one or more of the following generally accepted instructional categories comprising such programs, but including only instruction in regular programs, and excluding independently designed programs, individualized programs, and unstructured studies: (1) A program that is a structured combination of the arts, biological and physical sciences, social sciences, and humanities, emphasizing breadth of study. (2) An undifferentiated program that includes instruction in the general arts or general science. (3) A program that focuses on combined studies and research in humanities subjects as distinguished from the social and physical sciences, emphasizing languages, literature, art, music, philosophy, and religion. (4) Any single instructional program in liberal arts and sciences, general studies, and humanities not listed in paragraphs (e)(1) through (3) of this section." 34:34:3.1.3.1.1.1.1.6,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.6 Postsecondary vocational institution.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 64 FR 58616, Oct. 29, 1999; 74 FR 55933, Oct. 29, 2009; 75 FR 66946, Oct. 29, 2010; 84 FR 58915, Nov. 1, 2019]","(a) A postsecondary vocational institution is a public or private nonprofit educational institution that— (1) Is in a State; (2) Admits as regular students only persons who— (i) Have a high school diploma; (ii) Have the recognized equivalent of a high school diploma; or (iii) Are beyond the age of compulsory school attendance in the State in which the institution is physically located; (3) Is legally authorized to provide an educational program beyond secondary education in the State in which the institution is physically located in accordance with § 600.9; (4)(i) Provides an eligible program of training, as defined in 34 CFR 668.8, to prepare students for gainful employment in a recognized occupation; and (ii) May provide a comprehensive transition and postsecondary program for students with intellectual disabilities, as provided in 34 CFR part 668, subpart O; (5) Is— (i) Accredited or preaccredited; or (ii) Approved by a State agency listed in the Federal Register in accordance with 34 CFR part 603, if the institution is a public postsecondary vocational educational institution that seeks to participate only in Federal assistance programs; and (6) Has been in existence for at least two years. (b)(1) The Secretary considers an institution to have been in existence for two years only if— (i) The institution has been legally authorized to provide, and has provided, a continuous education or training program to prepare students for gainful employment in a recognized occupation during the 24 months preceding the date of its eligibility application; and (ii) The education or training program it provides on the date of its eligibility application is substantially the same in length and subject matter as the program it provided during the 24 months preceding the date of its eligibility application. (2)(i) The Secretary considers an institution to have provided a continuous education or training program during the 24 months preceding the date of its eligibility application even if the institution did not provide that program during normal vacation periods, or periods when the institution temporarily closed due to a natural disaster that affected the institution or the institution's students. (ii) The Secretary considers an institution to have satisfied the provisions of paragraph (b)(1)(ii) of this section if the institution substantially changed the subject matter of the educational program it provided during that 24-month period because of new technology or the requirements of other Federal agencies. (3) In determining whether an applicant institution satisfies the requirement contained in paragraph (b)(1) of this section, the Secretary— (i) Counts any period during which the applicant institution qualified as an eligible institution of higher education; (ii) Counts any period during which the applicant institution was part of another eligible institution of higher education, provided that the applicant institution continues to be part of an eligible institution of higher education; (iii) Counts any period during which the applicant institution has been certified as a branch campus; and (iv) Except as provided in paragraph (b)(3)(iii) of this section, does not count any period during which the applicant institution was a part of another eligible proprietary institution of higher education or postsecondary vocational institution. (c) An institution is physically located in a State or other instructional site if it has a campus or instructional site in that State. (d) The Secretary does not recognize the accreditation or preaccreditation of an institution unless the institution agrees to submit any dispute involving an adverse action, such as the final denial, withdrawal, or termination of accreditation, to arbitration before initiating any other legal action." 34:34:3.1.3.1.1.1.1.7,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.7 Conditions of institutional ineligibility.,ED,,,"[59 FR 22336, Apr. 29, 1994; 59 FR 32082, June 22, 1994, as amended at 59 FR 47801, Sept. 19, 1994; 60 FR 34430, June 30, 1995; 64 FR 58616, Oct. 29, 1999; 71 FR 45692, Aug. 9, 2006; 85 FR 54810, Sept. 2, 2020; 87 FR 65486, Oct. 28, 2022]","(a) General rule. For purposes of title IV of the HEA, an educational institution that otherwise satisfies the requirements contained in §§ 600.4, 600.5, or 600.6 nevertheless does not qualify as an eligible institution under this part if— (1) For its latest complete award year— (i) More than 50 percent of the institution's courses were correspondence courses as calculated under paragraph (b) of this section; (ii) Fifty percent or more of the institution's regular enrolled students were enrolled in correspondence courses; (iii) More than twenty-five percent of the institution's regular enrolled students were incarcerated; (iv) More than fifty percent of its regular enrolled students had neither a high school diploma nor the recognized equivalent of a high school diploma, and the institution does not provide a four-year or two-year educational program for which it awards a bachelor's degree or an associate degree, respectively; (2) The institution, or an affiliate of the institution that has the power, by contract or ownership interest, to direct or cause the direction of the management of policies of the institution— (A) Files for relief in bankruptcy, or (B) Has entered against it an order for relief in bankruptcy; or (3) The institution, its owner, or its chief executive officer— (i) Has pled guilty to, has pled nolo contendere to, or is found guilty of, a crime involving the acquisition, use, or expenditure of title IV, HEA program funds; or (ii) Has been judicially determined to have committed fraud involving title IV, HEA program funds. (b) Special provisions regarding correspondence courses and students —(1) Calculating the number of correspondence courses. For purposes of paragraphs (a)(1) (i) and (ii) of this section— (i) A correspondence course may be a complete educational program offered by correspondence, or one course provided by correspondence in an on-campus (residential) educational program; (ii) A course must be considered as being offered once during an award year regardless of the number of times it is offered during that year; and (iii) A course that is offered both on campus and by correspondence must be considered two courses for the purpose of determining the total number of courses the institution provided during an award year. (2) Calculating the number of correspondence students. For purposes of paragraph (a)(1)(ii) of this section, a student is considered “enrolled in correspondence courses” if the student's enrollment in correspondence courses constituted more than 50 percent of the courses in which the student enrolled during an award year. (3) Exceptions. (i) The provisions contained in paragraphs (a)(1) (i) and (ii) of this section do not apply to an institution that qualifies as a “technical institute or vocational school used exclusively or principally for the provision of vocational education to individuals who have completed or left high school and who are available for study in preparation for entering the labor market” under section 3(3)(C) of the Carl D. Perkins Vocational and Applied Technology Education Act of 1995. (ii) The Secretary waives the limitation contained in paragraph (a)(1)(ii) of this section for an institution that offers a 2-year associate-degree or a 4-year bachelor's-degree program if the students enrolled in the institution's correspondence courses receive no more than 5 percent of the title IV, HEA program funds received by students at that institution. (c) Special provisions regarding confined or incarcerated individuals. (1)(i) The Secretary may waive the prohibition contained in paragraph (a)(1)(iii) of this section, upon the application of an institution, if the institution is a nonprofit institution that provides four-year or two-year educational programs for which it awards a bachelor's degree, an associate degree, or a postsecondary diploma and has continuously provided an eligible prison education program approved by the Department under subpart P of 34 CFR part 668 for at least two years. (ii) The Secretary does not grant the waiver of the prohibition contained in paragraph (a)(1)(iii) of this section if— (A) For a program described under paragraph (c)(3)(ii) of this section, the program does not maintain a completion rate of 50 percent or greater; or (B) For an institution described under paragraph (c)(2) or (3) of this section— ( 1 ) The institution provides one or more eligible prison education programs that is not compliant with the requirements of 34 CFR part 668, subpart P; or ( 2 ) The institution is not administratively capable under 34 CFR 668.16 or financially responsible under 34 CFR part 668, subpart L. (2) If the nonprofit institution that applies for a waiver consists solely of four-year or two-year educational programs for which it awards a bachelor's degree, an associate degree, or a postsecondary diploma, the Secretary may waive the prohibition contained in paragraph (a)(1)(iii) of this section for the entire institution. (3) If the nonprofit institution that applies for a waiver does not consist solely of four-year or two-year educational programs for which it awards a bachelor's degree, an associate degree, or a postsecondary diploma, the Secretary may waive the prohibition contained in paragraph (a)(1)(iii) of this section on a program-by-program basis— (i) For the four-year and two-year programs for which the institution awards a bachelor's degree, an associate degree, or a postsecondary diploma; and (ii) For the other programs the institution provides, if the confined or incarcerated individuals who are regular students enrolled in those other programs have a completion rate of 50 percent or greater. (4)(i)(A) For five years after the Secretary grants the waiver, no more than 50 percent of the institution's regular enrolled students may be confined or incarcerated individuals; and (B) Following the period described in paragraph (c)(4)(i)(A) of this section, no more than 75 percent of the institution's regular enrolled students may be confined or incarcerated individuals. (ii) The limitations in paragraph (c)(4)(i) of this section do not apply if the institution is a public institution chartered for the explicit purpose of educating confined or incarcerated individuals, as determined by the Secretary, and all students enrolled in the institution's prison education program are located in the State where the institution is chartered. (5) The Secretary limits or terminates the waiver described in this section if the Secretary determines the institution no longer meets the requirements established under paragraph (c)(1) of this section. (6) If the Secretary limits or terminates an institution's waiver under paragraph (c) of this section, the institution ceases to be eligible for the title IV, HEA programs at the end of the award year that begins after the Secretary's action unless the institution, by that time— (i) Demonstrates to the satisfaction of the Secretary that it meets the requirements under paragraph (c)(1) of this section; and (ii) The institution does not enroll any additional confined or incarcerated individuals upon the limitation or termination of the waiver and reduces its enrollment of confined or incarcerated individuals to no more than 25 percent of its regular enrolled students. (d) Special provision for a nonprofit institution if more than 50 percent of its enrollment consists of students who do not have a high school diploma or its equivalent. (1) Subject to the provisions contained in paragraphs (d)(2) and (d)(3) of this section, the Secretary waives the limitation contained in paragraph (a)(1)(iv) of this section for a nonprofit institution if that institution demonstrates to the Secretary's satisfaction that it exceeds that limitation because it serves, through contracts with Federal, State, or local government agencies, significant numbers of students who do not have a high school diploma or its recognized equivalent. (2) Number of critical students. The Secretary grants a waiver under paragraph (d)(1) of this section only if no more than 40 percent of the institution's enrollment of regular students consists of students who— (i) Do not have a high school diploma or its equivalent; and (ii) Are not served through contracts described in paragraph (d)(3) of this section. (3) Contracts with Federal, State, or local government agencies. For purposes of granting a waiver under paragraph (d)(1) of this section, the contracts referred to must be with Federal, State, or local government agencies for the purpose of providing job training to low-income individuals who are in need of that training. An example of such a contract is a job training contract under the Job Training Partnership Act (JPTA). (e) Special provisions. (1) For purposes of paragraph (a)(1)of this section, when counting regular students, the institution shall— (i) Count each regular student without regard to the full-time or part-time nature of the student's attendance (i.e., “head count” rather than “full-time equivalent”); (ii) Count a regular student once regardless of the number of times the student enrolls during an award year; and (iii) Determine the number of regular students who enrolled in the institution during the relevant award year by— (A) Calculating the number of regular students who enrolled during that award year; and (B) Excluding from the number of students in paragraph (e)(1)(iii)(A) of this section, the number of regular students who enrolled but subsequently withdrew or were expelled from the institution and were entitled to receive a 100 percent refund of their tuition and fees less any administrative fee that the institution is permitted to keep under its fair and equitable refund policy. (2) For the purpose of calculating a completion rate under paragraph (c)(3)(ii) of this section, the institution shall— (i) Determine the number of regular incarcerated students who enrolled in the other programs during the last completed award year; (ii) Exclude from the number of regular incarcerated students determined in paragraph (e)(2)(i) of this section, the number of those students who enrolled but subsequently withdrew or were expelled from the institution and were entitled to receive a 100 percent refund of their tuition and fees, less any administrative fee the institution is permitted to keep under the institution's fair and equitable refund policy; (iii) Exclude from the total obtained in paragraph (e)(2)(ii) of this section, the number of those regular incarcerated students who remained enrolled in the programs at the end of the applicable award year; (iv) From the total obtained in paragraph (e)(2)(iii) of this section, determine the number of regular incarcerated students who received a degree, certificate, or other recognized educational credential awarded for successfully completing the program during the applicable award year; and (v) Divide the total obtained in paragraph (e)(2)(iv) of this section by the total obtained in paragraph (e)(2)(iii) of this section and multiply by 100. (f)(1) If the Secretary grants a waiver to an institution under this section, the waiver extends indefinitely provided that the institution satisfies the waiver requirements in each award year. (2) If an institution fails to satisfy the waiver requirements for an award year, the institution becomes ineligible on June 30 of that award year. (g)(1) For purposes of paragraph (a)(1) of this section, and any applicable waiver or exception under this section, the institution shall substantiate the required calculations by having the certified public accountant who prepares its audited financial statement under 34 CFR 668.15 or its title IV, HEA program compliance audit under 34 CFR 668.23 report on the accuracy of those determinations. (2) The certified public accountant's report must be based on performing an “attestation engagement” in accordance with the American Institute of Certified Public Accountants (AICPA's) Statement on Standards for Attestation Engagements. The certified public accountant shall include that attestation report with or as part of the audit report referenced in paragraph (g)(1) of this section. (3) The certified public accountant's attestation report must indicate whether the institution's determinations regarding paragraph (a)(1) of this section and any relevant waiver or exception under paragraphs (b), (c), and (d) of this section are accurate; i.e., fairly presented in all material respects. (h) Notice to the Secretary. An institution shall notify the Secretary— (1) By July 31 following the end of an award year if it falls within one of the prohibitions contained in paragraph (a)(1)of this section, or fails to continue to satisfy a waiver or exception granted under this section; or (2) Within 10 days if it falls within one of the prohibitions contained in paragraphs (a)(2) or (a)(3) of this section. (i) Regaining eligibility. (1) If an institution loses its eligibility because of one of the prohibitions contained in paragraph (a)(1) of this section, to regain its eligibility, it must demonstrate— (i) Compliance with all eligibility requirements; (ii) That it did not fall within any of the prohibitions contained in paragraph (a)(1) of this section for at least one award year; and (iii) That it changed its administrative policies and practices to ensure that it will not fall within any of the prohibitions contained in paragraph (a)(1) of this section. (2) If an institution loses its eligibility because of one of the prohibitions contained in paragraphs (a)(2) and (a)(3) of this section, this loss is permanent. The institution's eligibility cannot be reinstated." 34:34:3.1.3.1.1.1.1.8,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.8 Treatment of a branch campus.,ED,,,"[64 FR 58616, Oct. 29, 1999, as amended at 67 FR 67070, Nov. 1, 2002]",A branch campus of an eligible proprietary institution of higher education or a postsecondary vocational institution must be in existence for at least two years as a branch campus after the branch is certified as a branch campus before seeking to be designated as a main campus or a free-standing institution. 34:34:3.1.3.1.1.1.1.9,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",A,Subpart A—General,,§ 600.9 State authorization.,ED,,,"[75 FR 66946, Oct. 29, 2010, as amended at 81 FR 92262, Dec. 19, 2016; 81 FR 92261, Dec. 19, 2016; 85 FR 58915, Nov. 1, 2019]","(a)(1) An institution described under §§ 600.4, 600.5, and 600.6 is legally authorized by a State if the State has a process to review and appropriately act on complaints concerning the institution including enforcing applicable State laws, and the institution meets the provisions of paragraphs (a)(1)(i), (a)(1)(ii), or (b) of this section. (i)(A) The institution is established by name as an educational institution by a State through a charter, statute, constitutional provision, or other action issued by an appropriate State agency or State entity and is authorized to operate educational programs beyond secondary education, including programs leading to a degree or certificate. (B) The institution complies with any applicable State approval or licensure requirements, except that the State may exempt the institution from any State approval or licensure requirements based on the institution's accreditation by one or more accrediting agencies recognized by the Secretary or based upon the institution being in operation for at least 20 years. (ii) If an institution is established by a State on the basis of an authorization to conduct business in the State or to operate as a nonprofit charitable organization, but not established by name as an educational institution under paragraph (a)(1)(i) of this section, the institution— (A) By name, must be approved or licensed by the State to offer programs beyond secondary education, including programs leading to a degree or certificate; and (B) May not be exempt from the State's approval or licensure requirements based on accreditation, years in operation, or other comparable exemption. (2) The Secretary considers an institution to meet the provisions of paragraph (a)(1) of this section if the institution is authorized by name to offer educational programs beyond secondary education by— (i) The Federal Government; or (ii) As defined in 25 U.S.C. 1802(2), an Indian tribe, provided that the institution is located on tribal lands and the tribal government has a process to review and appropriately act on complaints concerning an institution and enforces applicable tribal requirements or laws. (b) An institution is considered to be legally authorized to operate educational programs beyond secondary education if it is exempt as a religious institution from State authorization under the State constitution or by State law. (c)(1)(i) If an institution that meets the requirements under paragraph (a)(1) or (b) of this section offers postsecondary education through distance education or correspondence courses to students located in a State in which the institution is not physically located or in which the institution is otherwise subject to that State's jurisdiction as determined by that State, except as provided in paragraph (c)(1)(ii) of this section, the institution must meet any of that State's requirements for it to be legally offering postsecondary distance education or correspondence courses in that State. The institution must, upon request, document the State's approval to the Secretary; or (ii) If an institution that meets the requirements under paragraph (a)(1) or (b) of this section offers postsecondary education through distance education or correspondence courses in a State that participates in a State authorization reciprocity agreement, and the institution is covered by such agreement, the institution is considered to meet State requirements for it to be legally offering postsecondary distance education or correspondence courses in that State, subject to any limitations in that agreement and to any additional requirements of that State not relating to State authorization of distance education. The institution must, upon request, document its coverage under such an agreement to the Secretary. (2)(i) For purposes of this section, an institution must make a determination, in accordance with the institution's policies or procedures, regarding the State in which a student is located, which must be applied consistently to all students. (ii) The institution must, upon request, provide the Secretary with written documentation of its determination of a student's location, including the basis for such determination. (iii) An institution must make a determination regarding the State in which a student is located at the time of the student's initial enrollment in an educational program and, if applicable, upon formal receipt of information from the student, in accordance with the institution's procedures, that the student's location has changed to another State. (d) An additional location or branch campus of an institution that meets the requirements under paragraph (a)(1) of this section and that is located in a foreign country, i.e., not in a State, must comply with §§ 600.8, 600.10, 600.20, and 600.32, and the following requirements: (1) For any additional location at which 50 percent or more of an educational program (as defined in § 600.2) is offered, or will be offered, or at a branch campus— (i) The additional location or branch campus must be legally authorized by an appropriate government authority to operate in the country where the additional location or branch campus is physically located, unless the additional location or branch campus is physically located on a U.S. military base, facility, or area that the foreign country has granted the U.S. military to use and the institution can demonstrate that it is exempt from obtaining such authorization from the foreign country; (ii) The institution must provide to the Secretary, upon request, documentation of such legal authorization to operate in the foreign country, demonstrating that the foreign governmental authority is aware that the additional location or branch campus provides postsecondary education and that the government authority does not object to those activities; (iii) The additional location or branch campus must be approved by the institution's recognized accrediting agency in accordance with § 602.22(a)(2)(ix) and (c). (iv) The additional location or branch campus must meet any additional requirements for legal authorization in that foreign country as the foreign country may establish; (v) The institution must report to the State in which the main campus of the institution is located at least annually, or more frequently if required by the State, the establishment or operation of each foreign additional location or branch campus; and (vi) The institution must comply with any limitations the State places on the establishment or operation of the foreign additional location or branch campus. (2) An additional location at which less than 50 percent of an educational program (as defined in § 600.2) is offered or will be offered must meet the requirements for legal authorization in that foreign country as the foreign country may establish. (3) In accordance with the requirements of 34 CFR 668.41, the institution must disclose to enrolled and prospective students at foreign additional locations and foreign branch campuses the information regarding the student complaint process described in 34 CFR 668.43(b), of the State in which the main campus of the institution is located. (4) If the State in which the main campus of the institution is located limits the authorization of the institution to exclude the foreign additional location or branch campus, the foreign additional location or branch campus is not considered to be legally authorized by the State." 34:34:3.1.3.1.1.2.1.1,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",B,Subpart B—Procedures for Establishing Eligibility,,"§ 600.20 Notice and application procedures for establishing, reestablishing, maintaining, or expanding institutional eligibility and certification.",ED,,,"[85 FR 54810, Sept. 2, 2020, as amended at 86 FR 49479, Sept. 3, 2021; 87 FR 65487, Oct. 28, 2022]","(a) Initial eligibility application. (1) An institution that wishes to establish its eligibility to participate in any HEA program must submit an application to the Secretary for a determination that it qualifies as an eligible institution under this part. The Secretary must ensure prompt action is taken by the Department on any materially complete application required under this section. (2) If the institution also wishes to be certified to participate in the title IV, HEA programs, it must indicate that intent on the application, and submit all the documentation indicated on the application to enable the Secretary to determine that it satisfies the relevant certification requirements contained in 34 CFR part 668, subparts B and L. (3) A freestanding foreign graduate medical school, or a foreign institution that includes a foreign graduate medical school, must include in its application to participate— (i)(A) A list of all medical school educational sites and where they are located, including all sites at which its students receive clinical training, except those clinical training sites that are not used regularly, but instead are chosen by individual students who take no more than two electives at the location for no more than a total of eight weeks; and (B) The type of clinical training (core, required clinical rotation, not required clinical rotation) offered at each site listed on the application in accordance with paragraph (a)(3)(i)(A) of this section; and (ii) Whether the school offers— (A) Only post-baccalaureate/equivalent medical programs, as defined in § 600.52; (B) Other types of programs that lead to employment as a doctor of osteopathic medicine or doctor of medicine; or (C) Both; and (iii) Copies of the formal affiliation agreements with hospitals or clinics providing all or a portion of a clinical training program required under § 600.55(e)(1). (b) Reapplication. (1) A currently designated eligible institution that is not participating in the title IV, HEA programs must apply to the Secretary for a determination that the institution continues to meet the requirements in this part if the Secretary requests the institution to reapply. If the institution chooses to be certified to participate in the title IV, HEA programs, it must submit an application to the Secretary and must submit all the supporting documentation indicated on the application to enable the Secretary to determine that it satisfies the relevant certification requirements contained in subparts B and L of 34 CFR part 668. (2)(i) A currently designated eligible institution that participates in the title IV, HEA programs must apply to the Secretary for a determination that the institution continues to meet the requirements in this part and in 34 CFR part 668 if the institution chooses to— (A) Continue to participate in the title IV, HEA programs beyond the scheduled expiration of the institution's current eligibility and certification designation; (B) Reestablish eligibility and certification as a private nonprofit, private for-profit, or public institution following a change in ownership that results in a change in control as described in § 600.31; or (C) Reestablish eligibility and certification after the institution changes its status as a proprietary, nonprofit, or public institution. (ii) The Secretary must ensure prompt action is taken by the Department on any materially complete application required under paragraph (a)(2)(i) of this section. (3) A freestanding foreign graduate medical school, or a foreign institution that includes a foreign graduate medical school, must include in its reapplication to participate— (i)(A) A list of all of the foreign graduate medical school's educational sites and where they are located, including all sites at which its students receive clinical training, except those clinical training sites that are not used regularly, but instead are chosen by individual students who take no more than two electives at the location for no more than a total of eight weeks; and (B) The type of clinical training (core, required clinical rotation, not required clinical rotation) offered at each site listed on the application in accordance with paragraph (b)(3)(i)(A) of this section; and (ii) Whether the school offers— (A) Only post-baccalaureate/equivalent medical programs, as defined in § 600.52; (B) Other types of programs that lead to employment as a doctor of osteopathic medicine or doctor of medicine; or (C) Both; and (iii) Copies of the formal affiliation agreements with hospitals or clinics providing all or a portion of a clinical training program required under § 600.55(e)(1). (c) Application to expand eligibility. A currently designated eligible institution that wishes to expand the scope of its eligibility and certification and disburse title IV, HEA Program funds to students enrolled in that expanded scope must apply to the Secretary and wait for approval to— (1) Add an educational program or a location at which the institution offers or will offer 50 percent or more of an educational program if one of the following conditions applies, otherwise it must report to the Secretary under § 600.21: (i) The institution participates in the title IV, HEA programs under a provisional certification, as provided in 34 CFR 668.13. (ii) The institution receives title IV, HEA program funds under the reimbursement or cash monitoring payment method, as provided in 34 CFR part 668, subpart K. (iii) The institution acquires the assets of another institution that provided educational programs at that location during the preceding year and participated in the title IV, HEA programs during that year. (iv) The institution would be subject to a loss of eligibility under 34 CFR 668.188 if it adds that location. (v) The Secretary notifies, or has notified, the institution that it must apply for approval of an additional educational program or a location under § 600.10(c). (2) Increase its level of program offering ( e.g., adding graduate degree programs when it previously offered only baccalaureate degree programs); (3) Add an educational program if the institution is required to apply to the Secretary for approval under § 600.10(c); (4) Add a branch campus at a location that is not currently included in the institution's eligibility and certification designation; (5) For a freestanding foreign graduate medical school, or a foreign institution that includes a foreign graduate medical school, add a location that offers all or a portion of the foreign graduate medical school's core clinical training or required clinical rotations, except for those locations that are included in the accreditation of a medical program accredited by the Liaison Committee on Medical Education (LCME) or the American Osteopathic Association (AOA); or (6) Convert an eligible location to a branch campus. (d) Notice and application —(1) Notice and application procedures. (i) To satisfy the requirements of paragraphs (a), (b), and (c) of this section, an institution must notify the Secretary of its intent to offer an additional educational program, or provide an application to expand its eligibility, in a format prescribed by the Secretary and provide all the information and documentation requested by the Secretary to make a determination of its eligibility and certification. (ii)(A) An institution that notifies the Secretary of its intent to offer an educational program under paragraph (c)(3) of this section must ensure that the Secretary receives the notice described in paragraph (d)(2) of this section at least 90 days before the first day of class of the educational program. (B) If an institution does not provide timely notice in accordance with paragraph (d)(1)(ii)(A) of this section, the institution must obtain approval of the additional educational program from the Secretary for title IV, HEA program purposes. (C) If an additional educational program is required to be approved by the Secretary for title IV, HEA program purposes under paragraph (d)(1)(ii)(B) of this section, the Secretary may grant approval, or request further information prior to making a determination of whether to approve or deny the additional educational program. (D) When reviewing an application under paragraph (d)(1)(ii)(C) of this section, the Secretary will take into consideration the following: ( 1 ) The institution's demonstrated financial responsibility and administrative capability in operating its existing programs. ( 2 ) Whether the additional educational program is one of several new programs that will replace similar programs currently provided by the institution, as opposed to supplementing or expanding the current programs provided by the institution. ( 3 ) Whether the number of additional educational programs being added is inconsistent with the institution's historic program offerings, growth, and operations. ( 4 ) Whether the process and determination by the institution to offer an additional educational program that leads to gainful employment in a recognized occupation is sufficient. (E)( 1 ) If the Secretary denies an application from an institution to offer an additional educational program, the denial will be based on the factors described in paragraphs (d)(1)(ii)(D)( 2 ) and ( 3 ) of this section, and the Secretary will explain in the denial how the institution failed to demonstrate that the program is likely to lead to gainful employment in a recognized occupation. ( 2 ) If the Secretary denies the institution's application to add an additional educational program, the Secretary will permit the institution to respond to the reasons for the denial and request reconsideration of the denial. (2) Notice format. An institution that notifies the Secretary of its intent to offer an additional educational program under paragraph (c)(3) of this section must at a minimum— (i) Describe in the notice how the institution determined the need for the program and how the program was designed to meet local market needs, or for an online program, regional or national market needs. This description must contain any wage analysis the institution may have performed, including any consideration of Bureau of Labor Statistics data related to the program; (ii) Describe in the notice how the program was reviewed or approved by, or developed in conjunction with, business advisory committees, program integrity boards, public or private oversight or regulatory agencies, and businesses that would likely employ graduates of the program; (iii) Submit documentation that the program has been approved by its accrediting agency or is otherwise included in the institution's accreditation by its accrediting agency, or comparable documentation if the institution is a public postsecondary vocational institution approved by a recognized State agency for the approval of public postsecondary vocational education in lieu of accreditation; and (iv) Provide the date of the first day of class of the new program. (e) Secretary's response to applications. (1) If the Secretary receives an application under paragraph (a) or (b)(1) of this section, the Secretary notifies the institution— (i) Whether the applicant institution qualifies in whole or in part as an eligible institution under the appropriate provisions in §§ 600.4 through 600.7; and (ii) Of the locations and educational programs that qualify as the eligible institution if only a portion of the applicant qualifies as an eligible institution. (2) If the Secretary receives an application under paragraph (a) or (b) of this section and that institution applies to participate in the title IV, HEA programs, the Secretary notifies the institution— (i) Whether the institution is certified to participate in those programs; (ii) Of the title IV, HEA programs in which it is eligible to participate; (iii) Of the title IV, HEA programs in which it is eligible to apply for funds; (iv) Of the effective date of its eligibility to participate in those programs; and (v) Of the conditions under which it may participate in those programs. (3) If the Secretary receives an application under paragraph (b)(2) of this section, the Secretary notifies the institution whether it continues to be certified, or whether it reestablished its eligibility and certification to participate in the title IV, HEA programs and the scope of such approval. (4) If the Secretary receives an application under paragraph (c)(1) of this section for an additional location, the Secretary notifies the institution whether the location is eligible or ineligible to participate in the title IV, HEA programs, and the date of eligibility if the location is determined eligible. (5) If the Secretary receives an application under paragraph (c)(2) of this section for an increase in the level of program offering, or for an additional educational program under paragraph (c)(3) of this section, the Secretary notifies the institution whether the program qualifies as an eligible program, and if the program qualifies, the date of eligibility. (6) If the Secretary receives an application under paragraph (c)(4) or (5) of this section to have a branch campus certified to participate in the title IV, HEA programs as a branch campus, the Secretary notifies the institution whether that branch campus is certified to participate and the date that the branch campus is eligible to begin participation. (f) Disbursement rules related to applications. (1)(i) Except as provided under paragraph (f)(1)(ii) of this section and 34 CFR 668.26, if an institution submits an application under paragraph (b)(2)(i) of this section because its participation period is scheduled to expire, after that expiration date the institution may not disburse title IV, HEA program funds to students attending that institution until the institution receives the Secretary's notification that the institution is again eligible to participate in those programs. (ii) An institution described in paragraph (f)(1)(i) of this section may disburse title IV, HEA program funds to its students if the institution submits to the Secretary a materially complete renewal application in accordance with the provisions of 34 CFR 668.13(b)(2), and has not received a final decision from the Department on that application. (2)(i) Except as provided under paragraph (f)(2)(ii) of this section and 34 CFR 668.26, if a private nonprofit, private for-profit, or public institution submits an application under paragraph (b)(2)(ii) or (iii) of this section because it has undergone or will undergo a change in ownership that results in a change of control or a change in status, the institution may not disburse title IV, HEA program funds to students attending that institution after the change of ownership or status until the institution receives the Secretary's notification that the institution is eligible to participate in those programs. (ii) An institution described in paragraph (f)(2)(i) of this section may disburse title IV, HEA program funds to its students if the Secretary issues a provisional extension of certification under paragraph (g) of this section. (3) If an institution must apply to the Secretary under paragraphs (c)(1) through (4) of this section, the institution may not disburse title IV, HEA program funds to students attending the subject location, program, or branch until the institution receives the Secretary's notification that the location, program, or branch is eligible to participate in the title IV, HEA programs. (4) If an institution applies to the Secretary under paragraph (c)(5) of this section to convert an eligible location to a branch campus, the institution may continue to disburse title IV, HEA program funds to students attending that eligible location. (5) If an institution does not apply to the Secretary to obtain the Secretary's approval of a new location, program, increased level of program offering, or branch, and the location, program, or branch does not qualify as an eligible location, program, or branch of that institution under this part and 34 CFR part 668, the institution is liable for all title IV, HEA program funds it disburses to students enrolled at that location or branch or in that program. (g) Application for provisional extension of certification. (1) If a private nonprofit institution, a private for-profit institution, or a public institution participating in the title IV, HEA programs undergoes a change in ownership that results in a change of control as described in § 600.31, the Secretary may continue the institution's participation in those programs on a provisional basis if— (i) No later than 90 days prior to the change in ownership, the institution provides the Secretary notice of the proposed change on a fully completed form designated by the Secretary and supported by the State authorization and accrediting documents identified in paragraphs (g)(3)(i) and (ii) of this section, and supported by copies of the financial statements identified in paragraphs (g)(3)(iii) and (iv) of this section; (ii) The institution promptly reports to the Secretary any changes to the proposed ownership structure identified under paragraph (g)(1)(i) of this section, provided that the change in ownership cannot occur earlier than 90 days following the date the change is reported to the Secretary; and (iii) The institution under the new ownership submits a “materially complete application” that is received by the Secretary no later than 10 business days after the day the change occurs. (2) Notwithstanding the submission of the items under paragraph (g)(1) of this section, the Secretary may determine that the participation of the institution should not be continued following the change in ownership. (3) For purposes of this section, a private nonprofit institution, a private for-profit institution, or a public institution submits a materially complete application if it submits a fully completed application form designated by the Secretary supported by— (i) A copy of the institution's State license or equivalent document that authorized or will authorize the institution to provide a program of postsecondary education in the State in which it is physically located, supplemented with documentation that, as of the day before the change in ownership, the State license remained in effect; (ii) A copy of the document from the institution's accrediting agency that granted or will grant the institution accreditation status, including approval of any non-degree programs it offers, supplemented with documentation that, as of the day before the change in ownership, the accreditation remained in effect; (iii) Audited financial statements for the institution's two most recently completed fiscal years that are prepared and audited in accordance with the requirements of 34 CFR 668.23; (iv)(A) Audited financial statements for the institution's new owner's two most recently completed fiscal years that are prepared and audited in accordance with the requirements of 34 CFR 668.23, or equivalent financial statements for that owner that are acceptable to the Secretary; or (B) If such financial statements are not available, financial protection in the amount of— ( 1 ) At least 25 percent of the institution's prior year volume of title IV aid if the institution's new owner does not have two years of acceptable audited financial statements; or ( 2 ) At least 10 percent of the institution's prior year volume of title IV aid if the institution's new owner has only one year of acceptable audited financial statements; and (v) If deemed necessary by the Secretary, financial protection in the amount of an additional 10 percent of the institution's prior year volume of title IV aid, or a larger amount as determined by the Secretary. If any entity in the new ownership structure holds a 50 percent or greater direct or indirect voting or equity interest in another institution or institutions, the financial protection may also include the prior year volume of title IV aid, or a larger amount as determined by the Secretary, for all institutions under such common ownership. (4) The institution must notify enrolled and prospective students of the proposed change in ownership, and submit evidence that such disclosure was made, no later than 90 days prior to the change. (h) Terms of the extension. (1) If the Secretary approves the institution's materially complete application, the Secretary provides the institution with a temporary provisional Program Participation Agreement (TPPPA). (2) The TPPPA expires on the earlier of— (i) The last day of the month following the month in which the change of ownership occurred, unless the provisions of paragraph (h)(3) of this section apply; (ii) The date on which the Secretary notifies the institution that its application is denied; or (iii) The date on which the Secretary co-signs a new provisional program participation agreement (PPPA). (3) If the TPPPA will expire under the provisions of paragraph (h)(2)(i) of this section, the Secretary extends the provisional TPPPA on a month-to-month basis after the expiration date described in paragraph (h)(2)(i) of this section if, prior to that expiration date, the institution provides the Secretary with— (i) An audited “same-day” balance sheet for a proprietary institution or an audited statement of financial position for a nonprofit institution; (ii) If not already provided, approval of the change of ownership from each State in which the institution is physically located or for an institution that offers only distance education, from the agency that authorizes the institution to legally provide postsecondary education in that State; (iii) If not already provided, approval of the change of ownership from the institution's accrediting agency; and (iv) A default management plan unless the institution is exempt from providing that plan under 34 CFR 668.14(b)(15)." 34:34:3.1.3.1.1.2.1.2,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",B,Subpart B—Procedures for Establishing Eligibility,,§ 600.21 Updating application information.,ED,,,"[65 FR 65673, Nov. 1, 2000, as amended at 67 FR 67070, Nov. 1, 2002; 71 FR 45692, Aug. 9, 2006; 75 FR 67193, Nov. 1, 2010; 79 FR 65006, Oct. 31, 2014; 84 FR 31452, July 1, 2019; 85 FR 54812, Sept. 2, 2020; 87 FR 65488, Oct. 28, 2022; 88 FR 70185, Oct. 10, 2023]","(a) Reporting requirements. Except as provided in paragraph (b) of this section, an eligible institution must report to the Secretary, in a manner prescribed by the Secretary and no later than 10 days after the change occurs, any change in the following: (1) Its name, the name of a branch, or the name of a previously reported location. (2) Its address, the address of a branch, or the address of a previously reported location. (3) Its establishment of an accredited and licensed additional location at which it offers or will offer 50 percent or more of an educational program if the institution wants to disburse title IV, HEA program funds to students enrolled at that location, under the provisions in paragraph (d) of this section. (4) Except as provided in 34 CFR 668.10, the way it measures program length ( e.g., from clock hours to credit hours, or from semester hours to quarter hours). (5) A decrease in the level of program offering ( e.g. the institution drops its graduate programs). (6)(i) Changes in ownership. (A) Any change in the ownership of the institution, whereby a natural person or entity acquires at least a 5 percent ownership interest (direct or indirect) of the institution but that does not result in a change of control as described in § 600.31. (B) Changes representing at least 5 percent but under 25 percent (either on a single or combined basis) must be reported quarterly (instead of within 10 days) based on the institution's fiscal year. However, when an institution plans to undergo a change in ownership, all unreported ownership changes of 5 percent or more in the existing ownership must be reported prior to submission of the 90-day notice required by § 600.20. Thereafter, any changes of 5 percent or more in the existing ownership must be reported within the 10-day deadline, up through the date of the change in ownership. (ii) Changes in control. A natural person or legal entity's ability to affect substantially the actions of the institution if that natural person or legal entity did not previously have this ability. The Secretary considers a natural person or legal entity to have this ability if— (A) The natural person acquires, alone or together with another member or members of their family, at least a 25 percent ownership interest (as defined in § 600.31(b)) in the institution; (B) The entity acquires, alone or together with an affiliated natural person or entity, at least a 25 percent ownership interest (as defined in § 600.31(b)) in the institution; (C) The natural person or entity acquires, alone or together with another natural person or entity, under a voting trust, power of attorney, proxy, or similar agreement, at least a 25 percent ownership interest (as defined in § 600.31(b)) in the institution; (D) The natural person becomes a general partner, managing member, chief executive officer, trustee or co-trustee of a trust, chief financial officer, director, or other officer of the institution or of an entity that has at least a 25 percent ownership interest (as defined in § 600.31(b)) in the institution; or (E) The entity becomes a general partner or managing member of an entity that has at least a 25 percent ownership interest (as defined in § 600.31(b)) in the institution. (7) The individual the institution designates under 34 CFR 668.16(b)(1) as its title IV, HEA Program administrator. (8) The closure of a branch campus or additional location that the institution was required to report to the Secretary. (9) The governance of a public institution. (10) For a freestanding foreign graduate medical school, or a foreign institution that includes a foreign graduate medical school, the school adds a location that offers all or a portion of the school's clinical rotations that are not required, except for those that are included in the accreditation of a medical program accredited by the Liaison Committee on Medical Education (LCME) or the American Osteopathic Association (AOA), or that are not used regularly, but instead are chosen by individual students who take no more than two electives at the location for no more than a total of eight weeks. (11) For any program that is required to provide training that prepares a student for gainful employment in a recognized occupation— (i) Establishing the eligibility or reestablishing the eligibility of the program; (ii) Discontinuing the program's eligibility; (iii) Ceasing to provide the program for at least 12 consecutive months; (iv) Losing program eligibility under § 600.40; (v) Changing the program's name, classification of instructional program (CIP) code, or credential level; or (vi) Updating the certification pursuant to 34 CFR 668.604(b). (12) Its addition of a second or subsequent direct assessment program. (13) Its establishment of a written arrangement for an ineligible institution or organization to provide more than 25 percent of a program pursuant to 34 CFR 668.5(c). (14) Its establishment or addition of an eligible prison education program at an additional location as defined under § 600.2 at a Federal, State, or local penitentiary, prison, jail, reformatory, work farm, juvenile justice facility, or other similar correctional institution that was not previously included in the institution's application for approval as described under § 600.10. (15) Any change in the ownership of the institution that does not result in a change of control as described in § 600.31 and is not addressed under paragraph (a)(6) of this section, including the addition or elimination of any entities in the ownership structure, a change of entity from one type of business structure to another, and any excluded transactions under § 600.31(e). (b) Additional reporting from institutions owned by publicly traded corporations. An institution that is owned by a publicly traded corporation must report to the Secretary any change in the information described in paragraph (a)(6) or (15) of this section when it notifies its accrediting agency, but no later than 10 days after the institution learns of the change. (c) Secretary's response to reporting. The Secretary notifies an institution if any reported changes affects the institution's eligibility, and the effective date of that change. (d) Disbursement rules related to additional locations. When an institution must report to the Secretary about an additional location under paragraph (a)(3) of this section, the institution may not disburse title IV, HEA funds to students at that location before it reports to the Secretary about that location. Unless it is an institution that must apply to the Secretary under § 600.20(c)(1), once it reports to the Secretary about that location, the institution may disburse those funds to those students if that location is licensed and accredited. (e) Consequence of failure to report. An institution's failure to inform the Secretary of a change described in paragraph (a) of this section within the time period stated in that paragraph may result in adverse action against the institution. (f) Definition. A family member includes a person's— (1) Parent or stepparent, sibling or step-sibling, spouse, child or stepchild, or grandchild or step-grandchild; (2) Spouse's parent or stepparent, sibling or step-sibling, child or stepchild, or grandchild or step-grandchild; (3) Child's spouse; and (4) Sibling's spouse." 34:34:3.1.3.1.1.2.1.3,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",B,Subpart B—Procedures for Establishing Eligibility,,§ 600.22 Severability.,ED,,,"[87 FR 65488, Oct. 28, 2022]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice will not be affected thereby." 34:34:3.1.3.1.1.3.1.1,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",C,Subpart C—Maintaining Eligibility,,§ 600.30 [Reserved],ED,,,, 34:34:3.1.3.1.1.3.1.2,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",C,Subpart C—Maintaining Eligibility,,"§ 600.31 Change in ownership resulting in a change in control for private nonprofit, private for-profit and public institutions.",ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 59 FR 47801, Sept. 19, 1994; 60 FR 33430, June 30, 1995; 64 FR 58616, Oct. 29, 1999; 65 FR 65673, Nov. 1, 2000; 67 FR 67070, Nov. 1, 2002; 84 FR 58916, Nov. 1, 2019; 87 FR 65488, Oct. 28, 2022]","(a)(1) Except as provided in paragraph (a)(2) of this section, a private nonprofit, private for-profit, or public institution that undergoes a change in ownership that results in a change in control ceases to qualify as an eligible institution upon the change in ownership and control. A change of ownership that results in a change in control includes any change by which a person who has or thereby acquires an ownership interest in the entity that owns the institution or the parent of that entity, acquires or loses the ability to control the institution. (2) If a private nonprofit, private for-profit, or public institution has undergone a change in ownership that results in a change in control, the Secretary may, under the provisions of § 600.20(g) and (h), continue the institution's participation in the title IV, HEA programs on a provisional basis, provided that the institution submits, under the provisions of § 600.20(g), a materially complete application— (i) No later than 10 business days after the change occurs; or (ii) For an institution owned by a publicly-traded corporation, no later than 10 business days after the institution knew, or should have known of the change based upon SEC filings, that the change occurred. (3) In order to reestablish eligibility and to resume participation in the title IV, HEA programs, the institution must demonstrate to the Secretary that after the change in ownership and control— (i) The institution satisfies all the applicable requirements contained in §§ 600.4, 600.5, and 600.6, except that if the institution is a proprietary institution of higher education or postsecondary vocational institution, it need not have been in existence for two years before seeking eligibility; and (ii) The institution qualifies to be certified to participate under 34 CFR part 668, subpart B. (b) Definitions. The following definitions apply to terms used in this section: Closely-held corporation. Closely-held corporation (including the term “close corporation”) means— (i) A corporation that qualifies under the law of the State of its incorporation or organization as a statutory close corporation; or (ii) If the State of incorporation or organization has no statutory close corporation provision, a corporation the stock of which— (A) Is held by no more than 30 persons; and (B) Has not been and is not planned to be publicly offered. Control. Control (including the terms controlling, controlled by and under common control with) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, or otherwise. Ownership or ownership interest. (i) Ownership or ownership interest means a direct or indirect legal or beneficial interest in an institution or legal entity, which may include a voting interest or a right to share in profits. (ii) For the purpose of determining whether a change in ownership has occurred, changes in the ownership of the following are not included: (A) A mutual fund that is regularly and publicly traded. (B) A U.S. institutional investor, as defined in 17 CFR 240.15a-6(b)(7). (C) A profit-sharing plan of the institution or its corporate parent, provided that all full-time permanent employees of the institution or its corporate parent are included in the plan. (D) An employee stock ownership plan (ESOP). Parent. The legal entity that controls the institution or a legal entity directly or indirectly through one or more intermediate entities. Person. Person includes a natural person or a legal entity, including a trust. Wholly-owned subsidiary. A wholly-owned subsidiary is one substantially all of whose outstanding voting securities are owned by its parent together with the parent's other wholly-owned subsidiaries. (c) Standards for identifying changes of ownership and control —(1) Closely-held corporation. A change in ownership and control occurs when— (i) A person acquires more than 50 percent of the total outstanding voting stock of the corporation; (ii) A person who holds an ownership interest in the corporation acquires control of more than 50 percent of the outstanding voting stock of the corporation; or (iii) A person who holds or controls 50 percent or more of the total outstanding stock of the corporation ceases to hold or control that proportion of the stock of the corporation. (2) Publicly traded corporations required to be registered with the Securities and Exchange Commission (SEC). A change in ownership and control occurs when— (i) A person acquires such ownership and control of the corporation so that the corporation is required to file a Form 8K with the SEC notifying that agency of the change in control; or (ii) (A) A person who is a controlling shareholder of the corporation ceases to be a controlling shareholder. A controlling shareholder is a shareholder who holds or controls through agreement both 25 percent or more of the total outstanding voting stock of the corporation and more shares of voting stock than any other shareholder. A controlling shareholder for this purpose does not include a shareholder whose sole stock ownership is held as a U.S. institutional investor, as defined in 17 CFR 240.15a-6(b)(7), held in mutual funds, held through a profit-sharing plan, or held in an Employee Stock Ownership Plan (ESOP). (B) When a change of ownership occurs as a result of paragraph (c)(2)(ii)(A) of this section, the institution may submit its most recent quarterly financial statement as filed with the SEC, along with copies of all other SEC filings made after the close of the fiscal year for which a compliance audit has been submitted to the Department of Education, instead of the “same day” balance sheet. (C) If a publicly-traded institution is provisionally certified due to a change in ownership under paragraph (c)(2)(ii) of this section, and that institution experiences another change of ownership under paragraph (c)(2)(ii) of this section, an approval of the subsequent change in ownership does not extend the original expiration date for the provisional certification provided that any current controlling shareholder was listed on the change of ownership application for which the original provisional approval was granted. (3) Other entities. (i) The term “other entities” means any entity that is not closely held nor required to be registered with the SEC, and includes limited liability companies, limited liability partnerships, limited partnerships, and similar types of legal entities. (ii) The Secretary deems the following changes to constitute a change in ownership resulting in a change of control of such an entity: (A) A person (or combination of persons) acquires at least 50 percent of the total outstanding voting interests in the entity, or otherwise acquires 50 percent control. (B) A person (or combination of persons) who holds less than a 50 percent voting interest in an entity acquires at least 50 percent of the outstanding voting interests in the entity, or otherwise acquires 50 percent control. (C) A person (or combination of persons) who holds at least 50 percent of the voting interests in the entity ceases to hold at least 50 percent voting interest in the entity, or otherwise ceases to hold 50 percent control. (D) A partner in a general partnership acquires or ceases to own at least 50 percent of the voting interests in the general partnership, or otherwise acquires or ceases to hold 50 percent control. (E) Any change of a general partner of a limited partnership (or similar entity) if that general partner also holds an equity interest. (F) Any change in a managing member of a limited liability company (or similar entity) if that managing member also holds an equity interest. (G) Notwithstanding its voting interests, a person becomes the sole member or shareholder of a limited liability company or other entity that has a 100 percent or equivalent direct or indirect interest in the institution. (H) An entity that has a member or members ceases to have any members. (I) An entity that has no members becomes an entity with a member or members. (J) A person is replaced as the sole member or shareholder of a limited liability company or other entity that has a 100 percent or equivalent direct or indirect interest in the institution. (K) The addition or removal of any entity that provides or will provide the audited financial statements to meet any of the requirements in § 600.20(g) or (h) or 34 CFR part 668, subpart L. (L) Except as provided in paragraph (e) of this section, the transfer by an owner of 50 percent or more of the voting interests in the institution or an entity to an irrevocable trust. (M) Except as provided in paragraph (e) of this section, upon the death of an owner who previously transferred 50 percent or more of the voting interests in an institution or an entity to a revocable trust. (iii) The Secretary deems the following interests to satisfy the 50 percent thresholds described in paragraph (c)(3)(ii) of this section: (A) A combination of persons, each of whom holds less than 50 percent ownership interest in an entity, holds a combined ownership interest of at least 50 percent as a result of proxy agreements, voting agreements, or other agreements (whether or not the agreement is set forth in a written document), or by operation of State law. (B) A combination of persons, each of whom holds less than 50 percent ownership interest in an entity, holds a combined ownership interest of at least 50 percent as a result of common ownership, management, or control of that entity, either directly or indirectly. (C) A combination of individuals who are family members as defined in § 600.21, each of whom holds less than 50 percent ownership interest in an entity, holds a combined ownership interest of at least 50 percent. (iv) Notwithstanding paragraphs (c)(3)(ii) and (iii) of this section— (A) If a person who alone or in combination with other persons holds less than a 50 percent ownership interest in an entity, the Secretary may determine that the person, either alone or in combination with other persons, has actual control over that entity and is subject to the requirements of this section; and (B) Any person who alone or in combination with other persons has the right to appoint a majority of any class of board members of an entity or an institution is deemed to have control. (4) Wholly owned subsidiary. An entity that is a wholly owned subsidiary changes ownership and control when its parent entity changes ownership and control as described in this section. (5) Nonprofit institution. A nonprofit institution changes ownership and control when a change takes place that is described in paragraphs (c)(3) and (d) of this section. (6) Public institution. The Secretary does not consider that a public institution undergoes a change in ownership that results in a change of control if there is a change in governance and the institution after the change remains a public institution, provided— (i) The new governing authority is in the same State as included in the institution's program participation agreement; and (ii) The new governing authority has acknowledged the public institution's continued responsibilities under its program participation agreement. (d) Covered transactions. For the purposes of this section, a change in ownership of an institution that results in a change of control may include, but is not limited to— (1) The sale of the institution; (2) The transfer of the controlling interest of stock of the institution or its parent corporation; (3) The merger of two or more eligible institutions; (4) The division of one institution into two or more institutions; (5) The transfer of the liabilities of an institution to its parent corporation; (6) A transfer of assets that comprise a substantial portion of the educational business of the institution, except where the transfer consists exclusively in the granting of a security interest in those assets; (7) A change whereby the institution's ownership changes from an entity that is for-profit, nonprofit, or public to another one of those statuses. However, when an institution's ownership changes from a for-profit entity to a nonprofit entity or becomes affiliated with a public system, the institution remains a proprietary institution until the Department approves the change of status for the institution; or (8) The acquisition of an institution to become an additional location of another institution unless the acquired institution closed or ceased to provide educational instruction. (e) Excluded transactions. A change in ownership and control timely reported under § 600.21 and otherwise subject to this section does not include a transfer of ownership and control of all or part of an owner's equity or partnership interest in an institution, the institution's parent corporation, or other legal entity that has signed the institution's PPA— (1) From an owner to a “family member” of that owner as defined in § 600.21(f); (2) As a result of a transfer of an owner's interest in the institution or an entity to an irrevocable trust, so long as the trustees only include the owner and/or a family member as defined in § 600.21(f). Upon the appointment of any non-family member as trustee for an irrevocable trust (or successor trust), the transaction is no longer excluded and is subject to the requirements of § 600.20(g) and (h); (3) Upon the death of a former owner who previously transferred an interest in the institution or an entity to a revocable trust, so long as the trustees include only family members (as defined in § 600.21(f)) of that former owner. Upon the appointment of any non-family member as trustee for the trust (or a successor trust) following the death of the former owner, the transaction is no longer excluded and is subject to the requirements of § 600.20(g) and (h); or (4) A transfer to an individual owner with a direct or indirect ownership interest in the institution who has been involved in the management of the institution for at least two years preceding the transfer and who has established and retained the ownership interest for at least two years prior to the transfer, either upon the death of another owner or by transfer from another individual owner who has been involved in the management of the institution for at least two years preceding the transfer and who has established and retained the ownership interest for at least two years prior to the transfer, upon the resignation of that owner from the management of the institution." 34:34:3.1.3.1.1.3.1.3,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",C,Subpart C—Maintaining Eligibility,,§ 600.32 Eligibility of additional locations.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 74 FR 55933, Oct. 29, 2009; 84 FR 58916, Nov. 1, 2019]","(a) Except as provided in paragraphs (b), (c), and (d) of this section, to qualify as an eligible location, an additional location of an eligible institution must satisfy the applicable requirements of this section and §§ 600.4, 600.5, 600.6, 600.8, and 600.10. (b) To qualify as an eligible location, an additional location is not required to satisfy the two-year requirement of §§ 600.5(a)(7) or 600.6(a)(6), unless— (1) The location was a facility of another institution that has closed or ceased to provide educational programs for a reason other than a normal vacation period or a natural disaster that directly affects the institution or the institution's students; (2) The applicant institution acquired, either directly from the institution that closed or ceased to provide educational programs, or through an intermediary, the assets at the location; and (3) The institution from which the applicant institution acquired the assets of the location— (i) Owes a liability for a violation of an HEA program requirement; and (ii) Is not making payments in accordance with an agreement to repay that liability. (c) Notwithstanding paragraph (b) of this section, an additional location is not required to satisfy the two-year requirement of § 600.5(a)(7) or § 600.6(a)(6) if the applicant institution and the original institution are not related parties and there is no commonality of ownership, control, or management between the institutions, as described in 34 CFR 668.188(b) and 34 CFR 668.207(b) and the applicant institution agrees— (1) To be liable for all improperly expended or unspent title IV, HEA program funds received during the current academic year and up to one academic year prior by the institution that has closed or ceased to provide educational programs; (2) To be liable for all unpaid refunds owed to students who received title IV, HEA program funds during the current academic year and up to one academic year prior; and (3) To abide by the policy of the institution that has closed or ceased to provide educational programs regarding refunds of institutional charges to students in effect before the date of the acquisition of the assets of the additional location for the students who were enrolled before that date. (d)(1) An institution that conducts a teach-out at a site of a closed institution or an institution engaged in a teach-out plan approved by the institution's agency may apply to have that site approved as an additional location if— (i) The closed institution ceased operations, or the closing institution is engaged in an orderly teach-out plan and the Secretary has evaluated and approved that plan; and (ii) The teach-out plan required under 34 CFR 668.14(b)(31) is approved by the closed or closing institution's accrediting agency. (2)(i) An institution that conducts a teach-out and is approved to add an additional location described in paragraph (d)(1) of this section— (A) Does not have to meet the requirement of § 600.5(a)(7) or § 600.6(a)(6) for the additional location described in paragraph (d)(1) of this section; (B) Is not responsible for any liabilities of the closed or closing institution as provided under paragraph (c)(1) and (c)(2) of this section if the institutions are not related parties and there is no commonality of ownership or management between the institutions, as described in 34 CFR 668.188(b) and 34 CFR 668.207(b); and (C) Will not have the default rate of the closed institution included in the calculation of its default rate, as would otherwise be required under 34 CFR 668.184 and 34 CFR 668.203, if the institutions are not related parties and there is no commonality of ownership or management between the institutions, as described in 34 CFR 668.188(b) and 34 CFR 668.207(b). (ii) As a condition for approving an additional location under paragraph (d)(1) of this section, the Secretary may require that payments from the institution conducting the teach-out to the owners or related parties of the closed institution, are used to satisfy any liabilities owed by the closed institution. (e) For purposes of this section, an “additional location” is a location of an institution that was not designated as an eligible location in the eligibility notification provided to an institution under § 600.21." 34:34:3.1.3.1.1.3.1.4,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",C,Subpart C—Maintaining Eligibility,,§ 600.33 Severability.,ED,,,"[84 FR 58917, Nov. 1, 2019]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:3.1.3.1.1.4.1.1,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",D,Subpart D—Loss of Eligibility,,§ 600.40 Loss of eligibility.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 63 FR 40622, July 29, 1998]","(a)(1) Except as provided in paragraphs (a) (2) and (3) of this section, an institution, or a location or educational program of an institution, loses its eligibility on the date that— (i) The institution, location, or educational program fails to meet any of the eligibility requirements of this part; (ii) The institution or location permanently closes; (iii) The institution or location ceases to provide educational programs for a reason other than a normal vacation period or a natural disaster that directly affects the institution, particular location, or the students of the institution or location; or (iv) For purposes of the title IV, HEA programs— (A) The institution's period of participation as specified under 34 CFR 668.13 expires; or (B) The institution's provisional certification is revoked under 34 CFR 668.13. (2) If an institution loses its eligibility because it violated the requirements of § 600.5(a)(8), as evidenced by the determination under provisions contained in § 600.5(d), it loses its eligibility on the last day of the fiscal year used in § 600.5(d), except that if an institution's latest fiscal year was described in § 600.7(h)(1), it loses its eligibility as of June 30, 1994. (3) If an institution loses its eligibility under the provisions of § 600.7(a)(1), it loses its eligibility on the last day of the award year being evaluated under that provision. (b) If the Secretary undertakes to terminate the eligibility of an institution because it violated the provisions of § 600.5(a)(8) or § 600.7(a), and the institution requests a hearing, the presiding official must terminate the institution's eligibility if it violated those provisions, notwithstanding its status at the time of the hearing. (c)(1) If the Secretary designates an institution or any of its educational programs or locations as eligible on the basis of inaccurate information or documentation, the Secretary's designation is void from the date the Secretary made the designation, and the institution or program or location, as applicable, never qualified as eligible. (2) If an institution closes its main campus or stops providing any educational programs on its main campus, it loses its eligibility as an institution, and that loss of eligibility includes all its locations and all its programs. Its loss of eligibility is effective on the date it closes that campus or stops providing any educational program at that campus. (d) Except as otherwise provided in this part, if an institution ceases to satisfy any of the requirements for eligibility under this part— (1) It must notify the Secretary within 30 days of the date that it ceases to satisfy that requirement; and (2) It becomes ineligible to continue to participate in any HEA program as of the date it ceases to satisfy any of the requirements." 34:34:3.1.3.1.1.4.1.2,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",D,Subpart D—Loss of Eligibility,,§ 600.41 Termination and emergency action proceedings.,ED,,,"[59 FR 22336, Apr. 29, 1994, as amended at 63 FR 40623, July 29, 1998; 75 FR 67193, Nov. 1, 2010; 84 FR 58917, Nov. 1, 2019; 87 FR 66039, Nov. 1, 2022]","(a) If the Secretary believes that a previously designated eligible institution as a whole, or at one or more of its locations, does not satisfy the statutory or regulatory requirements that define that institution as an eligible institution, the Secretary may— (1) Terminate the institution's eligibility designation in whole or as to a particular location— (i) Under the procedural provisions applicable to terminations contained in 34 CFR 668.81, 668.83, 668.86, 668.88, 668.89, 668.90(a)(1) and (4) and (c) through (f), and 668.91; or (ii) Under a show-cause hearing, if the institution's loss of eligibility results from— (A) Its previously qualifying as an eligible vocational school; (B) Its loss of accreditation or preaccreditation; (C) Its loss of legal authority to provide postsecondary education in the State in which it is physically located; (D) Its violations of the provisions contained in § 600.5(a)(8) or § 600.7(a); (E) Its permanently closing; or (F) Its ceasing to provide educational programs for a reason other than a normal vacation period or a natural disaster that directly affects the institution, a particular location, or the students of the institution or location; (2) Limit, under the provisions of 34 CFR 668.86, the authority of the institution to disburse, deliver, or cause the disbursement or delivery of funds under one or more title IV, HEA programs as otherwise provided under 34 CFR 668.26 for the benefit of students enrolled at the ineligible institution or location prior to the loss of eligibility of that institution or location; and (3) Initiate an emergency action under the provisions contained in 34 CFR 668.83 with regard to the institution's participation in one or more title IV, HEA programs. (b) If the Secretary believes that an educational program offered by an institution that was previously designated by the Secretary as an eligible institution under the HEA does not satisfy relevant statutory or regulatory requirements that define that educational program as part of an eligible institution, the Secretary may in accordance with the procedural provisions described in paragraph (a) of this section— (1) Undertake to terminate that educational program's eligibility under one or more of the title IV, HEA programs under the procedural provisions applicable to terminations described in paragraph (a) of this section; (2) Limit the institution's authority to deliver, disburse, or cause the delivery or disbursement of funds provided under that title IV, HEA program to students enrolled in that educational program, as otherwise provided in 34 CFR 668.26; and (3) Initiate an emergency action under the provisions contained in 34 CFR 668.83 with regard to the institution's participation in one or more title IV, HEA programs with respect to students enrolled in that educational program. (c)(1) An action to terminate and limit the eligibility of an institution as a whole or as to any of its locations or educational programs is initiated in accordance with 34 CFR 668.86(b) and becomes final 20 days after the Secretary notifies the institution of the proposed action, unless the designated department official receives by that date a request for a hearing or written material that demonstrates that the termination and limitation should not take place. (2) Once a termination under this section becomes final, the termination is effective with respect to any commitment, delivery, or disbursement of funds provided under an applicable title IV, HEA program by the institution— (i) Made to students enrolled in the ineligible institution, location, or educational program; and (ii) Made on or after the date of the act or omission that caused the loss of eligibility as to the institution, location, or educational program. (3) Once a limitation under this section becomes final, the limitation is effective with regard to any commitment, delivery, or disbursement of funds under the applicable title IV, HEA program by the institution— (i) Made after the date on which the limitation became final; and (ii) Made to students enrolled in the ineligible institution, location, or educational program. (d) After a termination under this section of the eligibility of an institution as a whole or as to a location or educational program becomes final, the institution may not originate applications for, make awards of or commitments for, deliver, or disburse funds under the applicable title IV, HEA program, except— (1) In accordance with the requirements of 34 CFR 668.26(c) with respect to students enrolled in the ineligible institution, location, or educational program; and (2) After satisfaction of any additional requirements, imposed pursuant to a limitation under paragraph (a)(2) of this section, which may include the following: (i) Completion of the actions required by 34 CFR 668.26(a) and (b). (ii) Demonstration that the institution has made satisfactory arrangements for the completion of actions required by 34 CFR 668.26(a) and (b). (iii) Securing the confirmation of a third party selected by the Secretary that the proposed disbursements or delivery of title IV, HEA program funds meet the requirements of the applicable program. (iv) Using institutional funds to make disbursements permitted under this paragraph and seeking reimbursement from the Secretary for those disbursements. (e) If the Secretary undertakes to terminate the eligibility of an institution, location, or program under paragraphs (a) and (b) of this section: (1) If the basis for the loss of eligibility is the loss of accreditation or preaccreditation, the sole issue is whether the institution, location, or program has the requisite accreditation or preaccreditation. The presiding official has no authority to consider challenges to the action of the accrediting agency. (2) If the basis for the loss of eligibility is the loss of legal authorization, the sole issue is whether the institution, location, or program has the requisite legal authorization. The presiding official has no authority to consider challenges to the action of a State agency in removing the legal authorization. (3) If the basis for the loss of eligibility of a foreign graduate medical school is one or more annual pass rates on the U.S. Medical Licensing Examination below the threshold required in § 600.55(f)(1)(ii), the sole issue is whether one or more of the foreign medical school's pass rate or rates for the preceding calendar year fell below that threshold. For a foreign graduate medical school that opted to have the Educational Commission for Foreign Medical Graduates (ECFMG) calculate and provide the pass rates directly to the Secretary for the preceding calendar year as permitted under § 600.55(d)(2) in lieu of the foreign graduate medical school providing pass rate data to the Secretary under § 600.55(d)(1)(iii), the ECFMG's calculations of the school's rates are conclusive; and the presiding official has no authority to consider challenges to the computation of the rate or rates by the ECFMG." 34:34:3.1.3.1.1.4.1.3,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",D,Subpart D—Loss of Eligibility,,§ 600.42 Severability.,ED,,,"[84 FR 58917, Nov. 1, 2019]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:3.1.3.1.1.5.1.1,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.51 Purpose and scope.,ED,,,"[59 FR 22063, Apr. 28, 1994, as amended at 71 FR 45692, Aug. 9, 2006; 75 FR 67193, Nov. 1, 2010]","(a) A foreign institution is eligible to apply to participate in the Federal Family Education Loan (FFEL) programs if it is comparable to an eligible institution of higher education located in the United States and has been approved by the Secretary in accordance with the provisions of this subpart. (b) This subpart E contains the procedures and criteria under which a foreign institution may be deemed eligible to apply to participate in the FFEL programs. (c) Applicability of other title IV, HEA program regulations. (1) A foreign institution must comply with all requirements for eligible and participating institutions except when made inapplicable by the HEA or when the Secretary, through publication in the Federal Register, identifies specific provisions as inapplicable to foreign institutions. (2)(i) A public or nonprofit foreign institution that meets the requirements of this subpart, and that also meets the requirements of this part except as provided in §§ 600.51(c)(1) and 600.54(a), is considered an “institution of higher education” for purposes of the title IV, HEA program regulations; and (ii) A for-profit foreign institution that meets the requirements of this subpart, and that also meets the requirements of this Part, except as provided in §§ 600.51(c)(1) and 600.54(a), is considered a “proprietary institution” for purposes of title IV, HEA program regulations. (d)(1) A program offered by a foreign school through any use of a telecommunications course, correspondence course, or direct assessment program is not an eligible program; (2) Correspondence course has the meaning given in § 600.2; (3) Direct assessment program has the meaning given in § 668.10(a)(1) of this chapter; (4) Telecommunications course is a course offered through any one or a combination of the technologies listed in the definition of telecommunications course in § 600.2, except that telecommunications technologies may be used to supplement and support instruction that is offered in a classroom located in the foreign country where the students and instructor are physically present." 34:34:3.1.3.1.1.5.1.2,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.52 Definitions.,ED,,,"[59 FR 22063, Apr. 28, 1994, as amended at 75 FR 67193, Nov. 1, 2010; 85 FR 54812, Sept. 2, 2020]","The following definitions apply to this subpart E: Associate degree school of nursing: A school that provides primarily or exclusively a two-year program of postsecondary education in professional nursing leading to a degree equivalent to an associate degree in the United States. Clinical training: The portion of a graduate medical education program that counts as a clinical clerkship for purposes of medical licensure comprising core, required clinical rotation, and not required clinical rotation. Collegiate school of nursing: A school that provides primarily or exclusively a minimum of a two-year program of postsecondary education in professional nursing leading to a degree equivalent to a bachelor of arts, bachelor of science, or bachelor of nursing in the United States, or to a degree equivalent to a graduate degree in nursing in the United States, and including advanced training related to the program of education provided by the school. Diploma school of nursing: A school affiliated with a hospital or university, or an independent school, which provides primarily or exclusively a two-year program of postsecondary education in professional nursing leading to the equivalent of a diploma in the United States or to equivalent indicia that the program has been satisfactorily completed. Foreign graduate medical school: A foreign institution (or, for a foreign institution that is a university, a component of that foreign institution) having as its sole mission providing an educational program that leads to a degree of medical doctor, doctor of osteopathic medicine, or the equivalent. A reference in these regulations to a foreign graduate medical school as “freestanding” pertains solely to those schools that qualify by themselves as foreign institutions and not to schools that are components of universities that qualify as foreign institutions. Foreign institution: (1) For the purposes of students who receive title IV aid, an institution that— (i) Is not located in the United States; (ii) Except as provided with respect to clinical training offered under § 600.55(h)(1), § 600.56(b), or § 600.57(a)(2)— (A) Has no U.S. location; (B) Has no written arrangements, within the meaning of 34 CFR 668.5, with institutions or organizations located in the United States for those institutions or organizations to provide a portion of an eligible program, as defined under 34 CFR 668.8, except for written arrangements for no more than 25 percent of the courses required by the program to be provided by eligible institutions located in the United States; and (C) Does not permit students to complete an eligible program by enrolling in courses offered in the United States, except that it may permit students to complete up to 25 percent of the program by— ( 1 ) Enrolling in the coursework, research, work, or special studies offered by an eligible institution in the United States; or ( 2 ) Participating in an internship or externship provided by an ineligible organization as described in 34 CFR 668.5(h)(2); (iii) Is legally authorized by the education ministry, council, or equivalent agency of the country in which the institution is located to provide an educational program beyond the secondary education level; and (iv) Awards degrees, certificates, or other recognized educational credentials in accordance with § 600.54(e) that are officially recognized by the country in which the institution is located. (2) Notwithstanding paragraph (1)(ii)(C) of this definition, independent research done by an individual student in the United States for not more than one academic year is permitted, if it is conducted during the dissertation phase of a doctoral program under the guidance of faculty, and the research is performed only in a facility in the United States. (3) If the educational enterprise enrolls students both within the United States and outside the United States, and the number of students who would be eligible to receive title IV, HEA program funds attending locations outside the United States is at least twice the number of students enrolled within the United States, the locations outside the United States must apply to participate as one or more foreign institutions and must meet all requirements of paragraph (1) of this definition, and the other requirements of this part. For the purposes of this paragraph (3), an educational enterprise consists of two or more locations offering all or part of an educational program that are directly or indirectly under common ownership. Foreign nursing school: A foreign institution (or, for a foreign institution that is a university, a component of that foreign institution) that is an associate degree school of nursing, a collegiate school of nursing, or a diploma school of nursing. A reference in these regulations to a foreign nursing school as “freestanding” pertains solely to those schools that qualify by themselves as foreign institutions and not to schools that are components of universities that qualify as foreign institutions. Foreign veterinary school: A foreign institution (or, for a foreign institution that is a university, a component of that foreign institution) having as its sole mission providing an educational program that leads to the degree of doctor of veterinary medicine, or the equivalent. A reference in these regulations to a foreign veterinary school as “freestanding” pertains solely to those schools that qualify by themselves as foreign institutions and not to schools that are components of universities that qualify as foreign institutions. National Committee on Foreign Medical Education and Accreditation (NCFMEA): The operational committee of medical experts established by the Secretary to determine whether the medical school accrediting standards used in other countries are comparable to those applied to medical schools in the United States, for purposes of evaluating the eligibility of accredited foreign graduate medical schools to participate in the title IV, HEA programs. Passing score: The minimum passing score as defined by the Educational Commission for Foreign Medical Graduates (ECFMG), or on the National Council Licensure Examination for Registered Nurses (NCLEX-RN), as applicable. Post-baccalaureate/equivalent medical program: A program offered by a foreign graduate medical school that requires, as a condition of admission, that its students have already completed their non-medical undergraduate studies and that consists solely of courses and training leading to employment as a doctor of medicine or doctor of osteopathic medicine. Secondary school: A school that provides secondary education as determined under the laws of the country in which the school is located." 34:34:3.1.3.1.1.5.1.3,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.53 Requesting an eligibility determination.,ED,,,,"(a) To be designated as eligible to apply to participate in the FFEL programs or to continue to be eligible beyond the scheduled expiration of the institution's current period of eligibility, a foreign institution must— (1) Apply on the form prescribed by the Secretary; and (2) Provide all the information and documentation requested by the Secretary to make a determination of that eligibility. (b) If a foreign institution fails to provide, release, or authorize release to the Secretary of information that is required in this subpart E, the institution is ineligible to apply to participate in the FFEL programs." 34:34:3.1.3.1.1.5.1.4,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.54 Criteria for determining whether a foreign institution is eligible to apply to participate in the Direct Loan Program.,ED,,,"[75 FR 67194, Nov. 1, 2010, as amended at 85 FR 54812, Sept. 2, 2020]","The Secretary considers a foreign institution to be comparable to an eligible institution of higher education in the United States and eligible to apply to participate in the Direct Loan Program if the foreign institution meets the following requirements: (a)(1) Except for a freestanding foreign graduate medical school, foreign veterinary school, or foreign nursing school, the foreign institution is a public or private nonprofit educational institution. (2) For a public or private nonprofit foreign institution, the institution meets the requirements of § 600.4, except § 600.4(a)(1), (a)(2), (a)(3), (a)(4)(ii), (a)(5), (b), (c), and any requirements the HEA or the Secretary has designated as inapplicable in accordance with § 600.51(c)(1). (3) For a for-profit foreign medical, veterinary, or nursing school, the school meets the requirements of § 600.5, except § 600.5(a)(2), (a)(3), (a)(4), (a)(5)(i)(B), (a)(5)(ii), (a)(6), (c), (d), (e) and any requirements the HEA or the Secretary has designated as inapplicable in accordance with § 600.51(c)(1). (b) The foreign institution admits as regular students only persons who— (1) Have a secondary school completion credential; or (2) Have the recognized equivalent of a secondary school completion credential. (c)(1) Notwithstanding 34 CFR 668.5, written arrangements between an eligible foreign institution and an ineligible entity are limited to those under which— (i) The ineligible entity is an institution that meets the requirements in paragraphs (1)(iii) and (iv) of the definition of “foreign institution” in § 600.52; and (ii) The ineligible foreign institution provides 25 percent or less of the educational program. (2) For the purpose of this paragraph (c), written arrangements do not include affiliation agreements for the provision of clinical training for foreign medical, veterinary, and nursing schools. (d) An additional location of a foreign institution must separately meet the definition of a foreign institution in § 600.52 if the additional location is— (1) Located outside of the country in which the main campus is located, except as provided in § 600.55(h)(1), § 600.56(b), § 600.57(a)(2), § 600.55(h)(3), and the definition of foreign institution found in § 600.52; or (2) Located within the same country as the main campus, but is not covered by the legal authorization of the main campus. (e) The foreign institution provides an eligible education program— (1) For which the institution is legally authorized to award a degree that is equivalent to an associate, baccalaureate, graduate, or professional degree awarded in the United States; (2) That is at least a two-academic-year program acceptable for full credit toward the equivalent of a baccalaureate degree awarded in the United States; or (3)(i) That is equivalent to at least a one-academic-year training program in the United States that leads to a certificate, degree, or other recognized educational credential and prepares students for gainful employment in a recognized occupation within the meaning of the gainful employment provisions. (ii) An institution must demonstrate to the satisfaction of the Secretary that the amount of academic work required by a program in paragraph (e)(3)(i) of this section is equivalent to at least the definition of an academic year in § 668.3. (f) For a for-profit foreign medical, veterinary, or nursing school— (1) No portion of an eligible medical or veterinary program offered may be at what would be an undergraduate level in the United States; and (2) The title IV, HEA program eligibility does not extend to any joint degree program. (g) Proof that a foreign institution meets the requirements of paragraph (1)(iii) of the definition of a foreign institution in § 600.52 may be provided to the Secretary by a legal authorization from the appropriate education ministry, council, or equivalent agency— (1) For all eligible foreign institutions in the country; (2) For all eligible foreign institutions in a jurisdiction within the country; or (3) For each separate eligible foreign institution in the country." 34:34:3.1.3.1.1.5.1.5,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.55 Additional criteria for determining whether a foreign graduate medical school is eligible to apply to participate in the Direct Loan Program.,ED,,,"[75 FR 67195, Nov. 1, 2010]","(a) General. (1) The Secretary considers a foreign graduate medical school to be eligible to apply to participate in the title IV, HEA programs if, in addition to satisfying the criteria of this part (except the criterion in § 600.54 that the institution be public or private nonprofit), the school satisfies the criteria of this section. (2) A foreign graduate medical school must provide, and in the normal course require its students to complete, a program of clinical training and classroom medical instruction of not less than 32 months in length, that is supervised closely by members of the school's faculty and that— (i) Is provided in facilities adequately equipped and staffed to afford students comprehensive clinical training and classroom medical instruction; (ii) Is approved by all medical licensing boards and evaluating bodies whose views are considered relevant by the Secretary; and (iii) As part of its clinical training, does not offer more than two electives consisting of no more than eight weeks per student at a site located in a foreign country other than the country in which the main campus is located or in the United States, unless that location is included in the accreditation of a medical program accredited by the Liaison Committee on Medical Education (LCME) or the American Osteopathic Association (AOA). (3) A foreign graduate medical school must appoint for the program described in paragraph (a)(2) of this section only those faculty members whose academic credentials are the equivalent of credentials required of faculty members teaching the same or similar courses at medical schools in the United States. (4) A foreign graduate medical school must have graduated classes during each of the two twelve-month periods immediately preceding the date the Secretary receives the school's request for an eligibility determination. (b) Accreditation. A foreign graduate medical school must— (1) Be approved by an accrediting body— (i) That is legally authorized to evaluate the quality of graduate medical school educational programs and facilities in the country where the school is located; and (ii) Whose standards of accreditation of graduate medical schools have been evaluated by the NCFMEA or its successor committee of medical experts and have been determined to be comparable to standards of accreditation applied to medical schools in the United States; or (2) Be a public or private nonprofit educational institution that satisfies the requirements in § 600.4(a)(5)(i). (c) Admission criteria. (1) A foreign graduate medical school having a post-baccalaureate/equivalent medical program must require students accepted for admission who are U.S. citizens, nationals, or permanent residents to have taken the Medical College Admission Test (MCAT) and to have reported their scores to the foreign graduate medical school; and (2) A foreign graduate medical school must determine the consent requirements for, and require the necessary consents of, all students accepted for admission for whom the school must report to enable the school to comply with the collection and submission requirements of paragraph (d) of this section. (d) Collection and submission of data. (1) A foreign graduate medical school must obtain, at its own expense, and submit, by the date required by paragraph (d)(3) of this section— (i) To its accrediting authority and, on request, to the Secretary, the scores on the MCAT or successor examination, of all students admitted during the preceding calendar year who are U.S. citizens, nationals, or eligible permanent residents, together with a statement of the number of times each student took the examination; (ii) To its accrediting authority and, on request, to the Secretary, the percentage of students graduating during the preceding calendar year (including at least all graduates who are U.S. citizens, nationals, or eligible permanent residents) who obtain placement in an accredited U.S. medical residency program; (iii) To the Secretary, except as provided for in paragraph (d)(2) of this section, all scores, disaggregated by step/test—i.e., Step 1, Step 2—Clinical Skills (Step 2-CS), and Step 2—Clinical Knowledge (Step 2-CK), or the successor examinations—and attempt, earned during the preceding calendar year by each student and graduate, on Step 1, Step 2-CS, and Step 2-CK, or the successor examinations, of the U.S. Medical Licensing Examination (USMLE), together with the dates the student has taken each test, including any failed tests; (iv) To the Secretary, a statement of its citizenship rate for the preceding calendar year for a school that is subject to paragraph (f)(1)(i)(A) of this section, together with a description of the methodology used in deriving the rate that is acceptable to the Secretary. (2) In lieu of submitting the information required in paragraph (d)(1)(iii) of this section to the Secretary, a foreign graduate medical school that is not subject to paragraph (f)(4) of this section may agree to allow the Educational Commission for Foreign Medical Graduates (ECFMG) or other responsible third party to calculate the rate described in paragraph (f)(1)(ii) and (f)(3) of this section for the preceding calendar year and provide the rate directly to the Secretary on the school's behalf with a copy to the foreign graduate medical school, provided— (i) The foreign graduate medical school has provided by April 30 to the Secretary written consent acceptable to the Secretary to reliance by the Secretary on the pass rate as calculated by the ECFMG or other responsible third party for purposes of determining compliance with paragraph (f)(1)(ii) and (f)(3) of this section for the preceding calendar year; and (ii) The foreign graduate medical school agrees in its written consent that for the preceding calendar year the rate as calculated by the ECFMG or other designated third party will be conclusive for purposes of determining compliance with paragraph (f)(1)(ii) and (f)(3) of this section. (3) A foreign graduate medical school must submit the data it collects in accordance with paragraph (d)(1) of this section no later than April 30 of each year, unless the Secretary specifies a different date through a notice in the Federal Register . (e) Requirements for clinical training. (1)(i) A foreign graduate medical school must have— (A) A formal affiliation agreement with any hospital or clinic at which all or a portion of the school's core clinical training or required clinical rotations are provided; and (B) Either a formal affiliation agreement or other written arrangements with any hospital or clinic at which all or a portion of its clinical rotations that are not required are provided, except for those locations that are not used regularly, but instead are chosen by individual students who take no more than two electives at the location for no more than a total of eight weeks. (ii) The agreements described in paragraph (e)(1)(i) of this section must state how the following will be addressed at each site— (A) Maintenance of the school's standards; (B) Appointment of faculty to the medical school staff; (C) Design of the curriculum; (D) Supervision of students; (E) Evaluation of student performance; and (F) Provision of liability insurance. (2) A foreign graduate medical school must notify its accrediting body within one year of any material changes in— (i) The educational programs, including changes in clinical training programs; and (ii) The overseeing bodies and in the formal affiliation agreements with hospitals and clinics described in paragraph (e)(1)(i) of this section. (f) Citizenship and USMLE pass rate percentages. (1)(i)(A) During the calendar year preceding the year for which any of the school's students seeks an title IV, HEA program loan, at least 60 percent of those enrolled as full-time regular students in the school and at least 60 percent of the school's most recent graduating class must have been persons who did not meet the citizenship and residency criteria contained in section 484(a)(5) of the HEA, 20 U.S.C. 1091(a)(5); or (B) The school must have had a clinical training program approved by a State prior to January 1, 2008, and must continue to operate a clinical training program in at least one State that approves the program; and (ii) Except as provided in paragraph (f)(4) of this section, for a foreign graduate medical school outside of Canada, for Step 1, Step 2-CS, and Step 2-CK, or the successor examinations, of the USMLE administered by the ECFMG, at least 75 percent of the school's students and graduates who took that step/test of the examination in the year preceding the year for which any of the school's students seeks a title IV, HEA program loan must have received a passing score on that step/test and are taking the step/test for the first time; or (2)(i) The school must have had a clinical training program approved by a State as of January 1, 1992; and (ii) The school must continue to operate a clinical training program in at least one State that approves the program. (3) In performing the calculation required in paragraph (f)(1)(ii) of this section, a foreign graduate medical school shall— (i) Include as a graduate each student who graduated from the school during the three years preceding the year for which the calculation is performed and who took that step/test for the first time in that year; and (ii) Include students and graduates who take more than one step/test of the USMLE examination for the first time in the same year in the denominator for each of those steps/tests; (4)(i) If the calculation described in paragraph (f)(1)(ii) of this section would result in any step/test pass rate based on fewer than eight students, a single pass rate for the school is determined instead based on the performance of the school's students and graduates on Step 1, Step 2-CS, and Step 2-CK combined; (ii) If combining the results on all three step/tests as permitted in paragraph (f)(4)(i) of this section would result in a pass rate based on fewer than eight step/test results, the school is deemed to have no pass rate for that year and the results for the year are combined with each subsequent year until a pass rate based on at least eight step/test results is derived. (g) Other criteria. (1) As part of establishing, publishing, and applying reasonable satisfactory academic progress standards, a foreign graduate medical school must include as a quantitative component a maximum timeframe in which a student must complete his or her educational program that must— (i) Be no longer than 150 percent of the published length of the educational program measured in academic years, terms, credit hours attempted, clock hours completed, etc., as appropriate; and (ii) Meet the requirements of § 668.16(e)(2)(ii)(B), (C) and (D). (2) A foreign graduate medical school must document the educational remediation it provides to assist students in making satisfactory academic progress. (3) A foreign graduate medical school must publish all the languages in which instruction is offered. (h) Location of a program. (1) Except as provided in paragraph (h)(3)(ii) of this section, all portions of a graduate medical education program offered to U.S. students must be located in a country whose medical school accrediting standards are comparable to standards used in the United States, as determined by the NCFMEA, except for clinical training sites located in the United States. (2) No portion of the graduate medical educational program offered to U.S. students, other than the clinical training portion of the program, may be located outside of the country in which the main campus of the foreign graduate medical school is located. (3)(i) Except as provided in paragraph (h)(3)(ii) of this section, for any part of the clinical training portion of the educational program located in a foreign country other than the country in which the main campus is located or in the United States, in order for students attending the site to be eligible to borrow title IV, HEA program funds— (A) The site must be located in an NCFMEA approved comparable foreign country; (B) The institution's medical accrediting agency must have conducted an on-site evaluation and specifically approved the clinical training site; and (C) Clinical instruction must be offered in conjunction with medical educational programs offered to students enrolled in accredited medical schools located in that approved foreign country. (ii) A clinical training site located in a foreign country other than the country in which the main campus is located or in the United States is not required to meet the requirements of paragraph (h)(3)(i) of this section in order for students attending that site to be eligible to borrow title IV, HEA program funds if— (A) The location is included in the accreditation of a medical program accredited by the Liaison Committee on Medical Education (LCME) or the American Osteopathic Association (AOA); or (B) No individual student takes more than two electives at the location and the combined length of the electives does not exceed eight weeks." 34:34:3.1.3.1.1.5.1.6,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.56 Additional criteria for determining whether a foreign veterinary school is eligible to apply to participate in the Direct Loan Program.,ED,,,"[75 FR 67197, Nov. 1, 2010]","(a) The Secretary considers a foreign veterinary school to be eligible to apply to participate in the Direct Loan Program if, in addition to satisfying the criteria in this part (except the criterion in § 600.54 that the institution be public or private nonprofit), the school satisfies all of the following criteria: (1) The school provides, and in the normal course requires its students to complete, a program of clinical and classroom veterinary instruction that is supervised closely by members of the school's faculty, and that is provided in facilities adequately equipped and staffed to afford students comprehensive clinical and classroom veterinary instruction through a training program for foreign veterinary students that has been approved by all veterinary licensing boards and evaluating bodies whose views are considered relevant by the Secretary. (2) The school has graduated classes during each of the two twelve-month periods immediately preceding the date the Secretary receives the school's request for an eligibility determination. (3) The school employs for the program described in paragraph (a)(1) of this section only those faculty members whose academic credentials are the equivalent of credentials required of faculty members teaching the same or similar courses at veterinary schools in the United States. (4) Effective July 1, 2015, the school is accredited or provisionally accredited by an organization acceptable to the Secretary for the purpose of evaluating veterinary programs. (b)(1) No portion of the foreign veterinary educational program offered to U.S. students, other than the clinical training portion of the program as provided for in paragraph (b)(2) of this section, may be located outside of the country in which the main campus of the foreign veterinary school is located; (2)(i) For a veterinary school that is neither public nor private nonprofit, the school's students must complete their clinical training at an approved veterinary school located in the United States; (ii) For a veterinary school that is public or private nonprofit, the school's students may complete their clinical training at an approved veterinary school located— (A) In the United States; (B) In the home country; or (C) Outside of the United States or the home country, if— ( 1 ) The location is included in the accreditation of a veterinary program accredited by the American Veterinary Medical Association (AVMA); or ( 2 ) No individual student takes more than two electives at the location and the combined length of the elective does not exceed eight weeks." 34:34:3.1.3.1.1.5.1.7,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.57 Additional criteria for determining whether a foreign nursing school is eligible to apply to participate in the Direct Loan Program.,ED,,,"[75 FR 67197, Nov. 1, 2010]","(a) Effective July 1, 2012 for a foreign nursing school that was participating in any title IV, HEA program on August 13, 2008, and effective July 1, 2011 for all other foreign nursing schools, the Secretary considers the foreign nursing school to be eligible to apply to participate in the Direct Loan Program if, in addition to satisfying the criteria in this part (except the criterion in § 600.54 that the institution be public or private nonprofit), the nursing school satisfies all of the following criteria: (1) The nursing school is an associate degree school of nursing, a collegiate school of nursing, or a diploma school of nursing. (2) The nursing school has an agreement with a hospital located in the United States or an accredited school of nursing located in the United States that requires students of the nursing school to complete the student's clinical training at the hospital or accredited school of nursing. (3) The nursing school has an agreement with an accredited school of nursing located in the United States providing that students graduating from the nursing school located outside of the United States also receive a degree from the accredited school of nursing located in the United States. (4) The nursing school certifies only Federal Stafford Loan program loans or Federal PLUS program loans, as those terms are defined in § 668.2, for students attending the nursing school. (5) The nursing school reimburses the Secretary for the cost of any loan defaults for current and former students included in the calculation of the institution's cohort default rate during the previous fiscal year. (6)(i) The nursing school determines the consent requirements for and requires the necessary consents of all students accepted for admission who are U.S. citizens, nationals, or eligible permanent residents to enable the school to comply with the collection and submission requirements of paragraph (a)(6)(ii) of this section. (ii) The nursing school annually either— (A) Obtains, at its own expense, all results achieved by students and graduates who are U.S. citizens, nationals, or eligible permanent residents on the National Council Licensure Examination for Registered Nurses (NCLEX-RN), together with the dates the student has taken the examination, including any failed examinations, and provides such results to the Secretary; or (B) Obtains a report or reports from the National Council of State Boards of Nursing (NCSB), or an NCSB affiliate or NCSB contractor, reflecting the percentage of the school's students and graduates taking the NCLEX-RN in the preceding year who passed the examination, or the data from which the percentage could be derived, and provides the report to the Secretary. (7) Not less than 75 percent of the school's students and graduates who are U.S. citizens, nationals, or eligible permanent residents who took the NCLEX-RN in the year preceding the year for which the institution is certifying a Federal Stafford Loan or a Federal Plus Loan, passed the examination. (8) The school provides, including under the agreements described in paragraphs (a)(2) and (a)(3) of this section, and in the normal course requires its students to complete, a program of clinical and classroom nursing instruction that is supervised closely by members of the school's faculty that is provided in facilities adequately equipped and staffed to afford students comprehensive clinical and classroom nursing instruction, through a training program for foreign nursing students that has been approved by all nurse licensing boards and evaluating bodies whose views are considered relevant by the Secretary. (9) The school has graduated classes during each of the two twelve-month periods immediately preceding the date the Secretary receives the school's request for an eligibility determination. (10) The school employs only those faculty members whose academic credentials are the equivalent of credentials required of faculty members teaching the same or similar courses at nursing schools in the United States. (b) For purposes of paragraph (a)(5) of this section, the cost of a loan default is the estimated future cost of collections on the defaulted loan. (c) The Department continues to collect on the Direct Loan after a school reimburses the Secretary for the amount specified in paragraph (b) of this section until the loan is paid in full or otherwise satisfied, or the loan account is closed out. (d) No portion of the foreign nursing program offered to U.S. students may be located outside of the country in which the main campus of the foreign nursing school is located, except for clinical sites located in the United States." 34:34:3.1.3.1.1.5.1.8,34,Education,VI,,600,"PART 600—INSTITUTIONAL ELIGIBILITY UNDER THE HIGHER EDUCATION ACT OF 1965, AS AMENDED",E,Subpart E—Eligibility of Foreign Institutions To Apply To Participate in the Federal Family Education Loan (FFEL) Programs,,§ 600.58 Duration of eligibility determination.,ED,,,"[59 FR 22063, Apr. 28, 1994. Redesignated at 64 FR 58616, Oct. 29, 1999, as amended at 69 FR 12275, Mar. 16, 2004. Redesignated at 75 FR 67197, Nov. 1, 2010]","(a) The eligibility of a foreign institution under this subpart expires six years after the date of the Secretary's determination that the institution is eligible to apply for participation, except that the Secretary may specify a shorter period of eligibility. In the case of a foreign graduate medical school, continued eligibility is dependent upon annual submission of the data and information required under § 600.55(a)(5)(i), subject to the terms described in § 600.53(b). (b) A foreign institution that has been determined eligible loses its eligibility on the date that the institution no longer meets any of the criteria in this subpart E. (c) Notwithstanding the provisions of 34 CFR 668.26, if a foreign institution loses its eligibility under this subpart E, an otherwise eligible student, continuously enrolled at the institution before the loss of eligibility, may receive an FFEL program loan for attendance at that institution for the academic year succeeding the academic year in which that institution lost its eligibility, if the student actually received an FFEL program loan for attendance at the institution for a period during which the institution was eligible under this subpart E." 40:40:32.0.1.4.44.1.13.1,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.001 General applicability.,EPA,,,"[76 FR 39524, July 6, 2011, as amended at 79 FR 23746, Apr. 28, 2014; 81 FR 74000, Oct. 25, 2016; 88 FR 4480, Jan. 24, 2023; 89 FR 28200, Apr. 18, 2024]","(a) The provisions of this part apply to 2008 and later model year automobiles that are not medium duty passenger vehicles (MDPV FE ), and to 2011 and later model year automobiles including MDPV FE . The test procedures in subpart B of this part also apply to 2014 and later heavy-duty vehicles subject to standards under 40 CFR part 86, subpart S. (b) The provisions of subparts A, D, and F of this part are optional through the 2011 model year in the following cases: (1) Manufacturers that produce only electric vehicles are exempt from the requirements of this subpart, except with regard to the requirements in those sections pertaining specifically to electric vehicles. (2) Manufacturers with worldwide production (excluding electric vehicle production) of less than 10,000 gasoline-fueled and/or diesel powered passenger automobiles and light trucks may optionally comply with the electric vehicle requirements in this subpart. (c) Unless stated otherwise, references to fuel economy or fuel economy data in this part shall also be interpreted to mean the related exhaust emissions of CO 2 , HC, and CO, and where applicable for alternative fuel vehicles, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC and CH 4 . References to average fuel economy shall be interpreted to also mean average carbon-related exhaust emissions and average CO 2 emissions. References to fuel economy data vehicles shall also be meant to refer to vehicles tested for carbon-related exhaust emissions for the purpose of demonstrating compliance with fleet average CO 2 standards in § 86.1818 of this chapter. (d) The model year of initial applicability for sections in this part is indicated by the section number. The two digits following the hyphen designate the first model year for which a section is applicable. An individual section continues to apply for later model years until it is replaced by a different section that applies starting in a later model year. Sections that have no two-digit suffix apply for all 2008 and later model year vehicles, except as noted in those sections. If a section has a two-digit suffix but the regulation references that section without including the two-digit suffix, this refers to the section applicable for the appropriate model year. This also applies for references to part 86 of this chapter. As an example, § 600.113-08 applies to the 2008 and subsequent model years until § 600.113-12 is applicable beginning with the 2012 model year. Section 600.111-08 would then apply only for 2008 through 2011 model year vehicles. (e) The term “you” in this part refers to manufacturers subject to the requirements of this part. (f) Unless we specify otherwise, send all reports and requests for approval to the Designated Compliance Officer (see § 600.002)." 40:40:32.0.1.4.44.1.13.10,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.011 Incorporation by reference.,EPA,,,"[76 FR 39530, July 6, 2011, as amended at 76 FR 57379, Sept. 15, 2011; 79 FR 23746, Apr. 28, 2014; 88 FR 4480, Jan. 24, 2023; 89 FR 28201, Apr. 18, 2024]","Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, EPA must publish a document in the Federal Register and the material must be available to the public. All approved incorporation by reference (IBR) material is available for inspection at EPA and at the National Archives and Records Administration (NARA). Contact EPA at: U.S. EPA, Air and Radiation Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004; www.epa.gov/dockets ; (202) 202-1744. For information on inspecting this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations.html or email fr.inspection@nara.gov . The material may be obtained from the following sources: (a) ASTM International (ASTM). ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; (610) 832-9585; www.astm.org . (1) ASTM D86-23, Standard Test Method for Distillation of Petroleum Products and Liquid Fuels at Atmospheric Pressure; Approved March 1, 2023; IBR approved for § 600.113-12(f). (2) ASTM D975-13a, Standard Specification for Diesel Fuel Oils, Approved December 1, 2013; IBR approved for § 600.107-08(b). (3) ASTM D1298-12b, Standard Test Method for Density, Relative Density, or API Gravity of Crude Petroleum and Liquid Petroleum Products by Hydrometer Method, Approved June 1, 2012; IBR approved for §§ 600.113-12(f); 600.510-12(g). (4) ASTM D1319-20a, Standard Test Method for Hydrocarbon Types in Liquid Petroleum Products by Fluorescent Indicator Adsorption, Approved August 1, 2020; IBR approved for § 600.113-12(f). (5) ASTM D1945-03 (Reapproved 2010), Standard Test Method for Analysis of Natural Gas By Gas Chromatography, Approved January 1, 2010; IBR approved for § 600.113-12(f) and (k). (6) ASTM D3338/D3338M-20a, Standard Test Method for Estimation of Net Heat of Combustion of Aviation Fuels, Approved December 1, 2020; IBR approved for § 600.113-12(f). (7) ASTM D3343-22, Standard Test Method for Estimation of Hydrogen Content of Aviation Fuels, Approved November 1, 2022; IBR approved for § 600.113-12(f). (8) ASTM D4052-22, Standard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter, Approved May 1, 2022; IBR approved for § 600.113-12(f). (9) ASTM D4815-22, Standard Test Method for Determination of MTBE, ETBE, TAME, DIPE, tertiary-Amyl Alcohol and C 1 to C 4 Alcohols in Gasoline by Gas Chromatography, Approved April 1, 2022; IBR approved for § 600.113-12(f). (10) ASTM D5599-22, Standard Test Method for Determination of Oxygenates in Gasoline by Gas Chromatography and Oxygen Selective Flame Ionization Detection, Approved April 1, 2022; IBR approved for § 600.113-12(f). (11) ASTM D5769-22, Standard Test Method for Determination of Benzene, Toluene, and Total Aromatics in Finished Gasolines by Gas Chromatography/Mass Spectrometry, Approved July 1, 2022; IBR approved for § 600.113-12(f). (b) International Organization for Standardization (ISO). International Organization for Standardization, Case Postale 56, CH-1211 Geneva 20, Switzerland; (41) 22749 0111; central@iso.org ; www.iso.org . (1) ISO/IEC 18004:2006(E), Information technology—Automatic identification and data capture techniques—QR Code 2005 bar code symbology specification, Second Edition, September 1, 2006; IBR approved for § 600.302-12(b). (2) [Reserved] (c) SAE International (SAE). SAE International, 400 Commonwealth Dr., Warrendale, PA 15096-0001; (877) 606-7323 (U.S. and Canada) or (724) 776-4970 (outside the U.S. and Canada); www.sae.org . (1) Motor Vehicle Dimensions—Recommended Practice SAE 1100a (Report of Human Factors Engineering Committee, Society of Automotive Engineers, approved September 1973 as revised September 1975); IBR approved for § 600.315-08(c). (2) SAE J1634 JUL2017, Battery Electric Vehicle Energy Consumption and Range Test Procedure, Revised July 2017; IBR approved for §§ 600.116-12(a); 600.210-12(d); 600.311-12(j) and (k). (3) SAE J1711 FEB2023, Recommended Practice for Measuring the Exhaust Emissions and Fuel Economy of Hybrid-Electric Vehicles, Including Plug-In Hybrid Vehicles; Revised February 2023; IBR approved for §§ 600.114-12(c) and (f); 600.116-12(b) and (c); 600.311-12(c), (j), and (k)." 40:40:32.0.1.4.44.1.13.2,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.002 Definitions.,EPA,,,"[76 FR 39524, July 6, 2011, as amended at 77 FR 63178, Oct. 15, 2012; 79 FR 23746, Apr. 28, 2014; 81 FR 74000, Oct. 25, 2016; 88 FR 4480, Jan. 24, 2023; 89 FR 28200, Apr. 18, 2024]","The following definitions apply throughout this part: 3-bag FTP means the Federal Test Procedure specified in part 86 of this chapter, with three sampling portions consisting of the cold-start transient (“Bag 1”), stabilized (“Bag 2”), and hot-start transient phases (“Bag 3”). 4-bag FTP means the 3-bag FTP, with the addition of a sampling portion for the hot-start stabilized phase (“Bag 4”). 5-cycle means the FTP, HFET, US06, SC03 and cold temperature FTP tests as described in subparts B and C of this part. Administrator means the Administrator of the Environmental Protection Agency or his authorized representative. Alcohol means a mixture containing 85 percent or more by volume methanol, denatured ethanol, or other alcohols, in any combination. Alcohol-fueled automobile means an automobile designed to operate on alcohol, but not on gasoline. Alcohol dual fuel automobile means an automobile: (1) Which is designed to operate on alcohol and on gasoline or diesel fuel; and (2) Which provides equal or greater energy efficiency as calculated in accordance with § 600.510-08(g)(1) or § 600.510-12(g)(1) while operating on alcohol as it does while operating on gasoline or diesel fuel; and (3) Which, in the case of passenger automobiles, meets or exceeds the minimum driving range established by the Department of Transportation in 49 CFR part 538. Alternative fuel means any of the following: (1) Methanol. (2) Denatured ethanol. (3) Other alcohols. (4) A mixture containing at least 85 percent (or an alternative percentage as specified by the Secretary of Transportation under 49 U.S.C. 32901(b)) of methanol, denatured ethanol, and other alcohols by volume with gasoline or other fuels. (5) Natural gas. (6) Liquefied petroleum gas. (7) Hydrogen. (8) Coal derived liquid fuels. (9) Fuels (except alcohol) derived from biological materials. (10) Electricity (including electricity from solar energy). (11) Any other fuel the Secretary of Transportation prescribes by regulation under 49 U.S.C. 32901(a)(1)(K). Automobile has the meaning given by the Department of Transportation at 49 CFR 523.3. This includes “passenger automobiles” and “non-passenger automobiles” (or “light trucks”). Auxiliary emission control device (AECD) means an element of design as defined in § 86.1803 of this chapter. Average fuel economy means the unique fuel economy value as computed under § 600.510 for a specific class of automobiles produced by a manufacturer that is subject to average fuel economy standards. Axle ratio means the number of times the input shaft to the differential (or equivalent) turns for each turn of the drive wheels. Base level means a unique combination of basic engine, inertia weight class and transmission class. Base tire means the tire size specified as standard equipment by the manufacturer on each unique combination of a vehicle's footprint and model type. Standard equipment is defined in 40 CFR 86.1803-01. Base vehicle means the lowest priced version of each body style that makes up a car line. Basic engine means a unique combination of manufacturer, engine displacement, number of cylinders, fuel system (e.g., type of fuel injection), catalyst usage, and other engine and emission control system characteristics specified by the Administrator. For electric vehicles, basic engine means a unique combination of manufacturer and electric traction motor, motor controller, battery configuration, electrical charging system, energy storage device, and other components as specified by the Administrator. Battery configuration means the electrochemical type, voltage, capacity (in Watt-hours at the c/3 rate), and physical characteristics of the battery used as the tractive energy device. Body style means a level of commonality in vehicle construction as defined by number of doors and roof treatment (e.g., sedan, convertible, fastback, hatchback) and number of seats ( i.e., front, second, or third seat) requiring seat belts pursuant to National Highway Traffic Safety Administration safety regulations in 49 CFR part 571. Station wagons and light trucks are identified as car lines. Calibration means the set of specifications, including tolerances, unique to a particular design, version of application of a component, or component assembly capable of functionally describing its operation over its working range. Carbon-related exhaust emissions (CREE ) means the summation of the carbon-containing constituents of the exhaust emissions, with each constituent adjusted by a coefficient representing the carbon weight fraction of each constituent relative to the CO 2 carbon weight fraction, as specified in § 600.113. For example, carbon-related exhaust emissions (weighted 55 percent city and 45 percent highway) are used to demonstrate compliance with fleet average CO 2 emission standards outlined in § 86.1818 of this chapter. Car line means a name denoting a group of vehicles within a make or car division which has a degree of commonality in construction (e.g., body, chassis). Car line does not consider any level of decor or opulence and is not generally distinguished by characteristics as roof line, number of doors, seats, or windows, except for station wagons or light-duty trucks. Station wagons and light-duty trucks are considered to be different car lines than passenger cars. Certification vehicle means a vehicle which is selected under § 86.1828 of this chapter and used to determine compliance under § 86.1848 of this chapter for issuance of an original certificate of conformity. City fuel economy means the city fuel economy determined by operating a vehicle (or vehicles) over the driving schedule in the Federal emission test procedure, or determined according to the vehicle-specific 5-cycle or derived 5-cycle procedures. Cold temperature FTP means the test performed under the provisions of subpart C of part 86 of this chapter. Combined fuel economy means: (1) The fuel economy value determined for a vehicle (or vehicles) by harmonically averaging the city and highway fuel economy values, weighted 0.55 and 0.45, respectively. (2) For electric vehicles, for the purpose of calculating average fuel economy pursuant to the provisions of part 600, subpart F, the term means the equivalent petroleum-based fuel economy value as determined by the calculation procedure promulgated by the Secretary of Energy. For the purpose of labeling pursuant to the provisions of part 600, subpart D, the term means the fuel economy value as determined by the procedures specified in § 600.116-12. Dealer means a person who resides or is located in the United States, any territory of the United States, or the District of Columbia and who is engaged in the sale or distribution of new automobiles to the ultimate purchaser. Derived 5-cycle fuel economy means the 5-cycle fuel economy derived from the FTP-based city and HFET-based highway fuel economy by means of the equation provided in § 600.210. Derived 5-cycle CO 2 means the 5-cycle CO 2 derived from the FTP-based city and HFET-based highway fuel economy by means of the equation provided in § 600.210. Designated Compliance Officer means the Director, Light-Duty Vehicle Center, U.S. Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; complianceinfo@epa.gov; www.epa.gov/ve-certification . Diesel gallon equivalent means an amount of electricity or fuel with the energy equivalence of one gallon of diesel fuel. For purposes of this part, one gallon of diesel fuel is equivalent to 36.7 kilowatt-hours of electricity. Drive system is determined by the number and location of drive axles (e.g., front wheel drive, rear wheel drive, four wheel drive) and any other feature of the drive system if the Administrator determines that such other features may result in a fuel economy difference. Dual fueled automobile means an automobile: (1) Which is designed to operate on an alternative fuel and on gasoline or diesel fuel; and (2) Which provides equal or greater energy efficiency as calculated in accordance with § 600.510-08(g)(1) or § 600.510-12(g)(1) while operating on the alternative fuel as it does while operating on gasoline or diesel fuel; and (3) Which, in the case of passenger automobiles, meets or exceeds the minimum driving range established by the Department of Transportation in 49 CFR part 538. Electrical charging system means a device to convert 60 Hz alternating electric current, as commonly available in residential electric service in the United States, to a proper form for recharging the energy storage device. Electric traction motor means an electrically powered motor which provides tractive energy to the wheels of a vehicle. Electric vehicle has the meaning given in § 86.1803 of this chapter. Emergency vehicle means a motor vehicle manufactured primarily for use as an ambulance or combination ambulance-hearse or for use by the United States Government or a State or local government for law enforcement. Energy storage device means a rechargeable means of storing tractive energy on board a vehicle such as storage batteries or a flywheel. Engine code means one of the following: (1) For LDV, LDT, and MDPV FE , engine code means a unique combination, within a test group (as defined in § 86.1803 of this chapter), of displacement, fuel injection (or carburetion or other fuel delivery system), calibration, distributor calibration, choke calibration, auxiliary emission control devices, and other engine and emission control system components specified by the Administrator. For electric vehicles, engine code means a unique combination of manufacturer, electric traction motor, motor configuration, motor controller, and energy storage device. (2) For HDV, engine code has the meaning given in § 86.1819-14(d)(12) of this chapter. Federal emission test procedure (FTP) refers to the dynamometer driving schedule, dynamometer procedure, and sampling and analytical procedures described in part 86 of this chapter for the respective model year, which are used to derive city fuel economy data. Footprint has the meaning given in § 86.1803 of this chapter. FTP-based city fuel economy means the fuel economy determined in § 600.113 of this part, on the basis of FTP testing. Fuel means: (1) Gasoline and diesel fuel for gasoline- or diesel-powered automobiles; or (2) Electrical energy for electrically powered automobiles; or (3) Alcohol for alcohol-powered automobiles; or (4) Natural gas for natural gas-powered automobiles; or (5) Liquid Petroleum Gas (LPG), commonly referred to as “propane,” for LPG-powered automobiles; or (6) Hydrogen for hydrogen fuel cell automobiles and for automobiles equipped with hydrogen internal combustion engines. Fuel cell has the meaning given in § 86.1803 of this chapter. Fuel cell vehicle has the meaning given in § 86.1803 of this chapter. Fuel economy means: (1) The average number of miles traveled by an automobile or group of automobiles per volume of fuel consumed as calculated in this part; or (2) For the purpose of calculating average fuel economy pursuant to the provisions of part 600, subpart F, fuel economy for electrically powered automobiles means the equivalent petroleum-based fuel economy as determined by the Secretary of Energy in accordance with the provisions of 10 CFR 474. For the purpose of labeling pursuant to the provisions of part 600, subpart D, the term means the fuel economy value as determined by the procedures specified in § 600.116-12. Fuel economy data vehicle means a vehicle used for the purpose of determining fuel economy which is not a certification vehicle. Gasoline gallon equivalent means an amount of electricity or fuel with the energy equivalence of one gallon of gasoline. For purposes of this part, one gallon of gasoline is equivalent to 33.705 kilowatt-hours of electricity or 121.5 standard cubic feet of natural gas. Good engineering judgment has the meaning given in § 1068.30 of this chapter. See § 1068.5 of this chapter for the administrative process we use to evaluate good engineering judgment. Gross vehicle weight rating means the manufacturer's gross weight rating for the individual vehicle. Hatchback means a passenger automobile where the conventional luggage compartment, i.e., trunk, is replaced by a cargo area which is open to the passenger compartment and accessed vertically by a rear door which encompasses the rear window. Highway fuel economy means the highway fuel economy determined either by operating a vehicle (or vehicles) over the driving schedule in the Federal highway fuel economy test procedure, or determined according to either the vehicle-specific 5-cycle equation or the derived 5-cycle equation for highway fuel economy. Highway fuel economy test procedure (HFET) refers to the dynamometer driving schedule, dynamometer procedure, and sampling and analytical procedures described in subpart B of this part and which are used to derive highway fuel economy data. HFET-based fuel economy means the highway fuel economy determined in § 600.113 of this part, on the basis of HFET testing. Hybrid electric vehicle (HEV) has the meaning given in § 86.1803 of this chapter. Independent Commercial Importer has the meaning given in § 85.1502 of this chapter. Inertia weight class means the class, which is a group of test weights, into which a vehicle is grouped based on its loaded vehicle weight in accordance with the provisions of part 86 of this chapter. Label means a sticker that contains fuel economy information and is affixed to new automobiles in accordance with subpart D of this part. Light truck means an automobile that is not a passenger automobile, as defined by the Secretary of Transportation at 49 CFR 523.5. This term is interchangeable with “non-passenger automobile.” The term “light truck” includes medium-duty passenger vehicles (MDPV FE ) manufactured during 2011 and later model years. Medium-duty passenger vehicle (MDPV FE ) means a vehicle that would satisfy the criteria for light trucks as defined by the Secretary of Transportation at 49 CFR 523.5 but for its gross vehicle weight rating or its curb weight, is rated at more than 8,500 lbs GVWR or has a vehicle curb weight of more than 6,000 pounds or has a basic vehicle frontal area in excess of 45 square feet, and is designed primarily to transport passengers, but does not include a vehicle that— (1) Is an “incomplete truck” as defined in 40 CFR 86.1803-01; or (2) Has a seating capacity of more than 12 persons; or (3) Is designed for more than 9 persons in seating rearward of the driver's seat; or (4) Is equipped with an open cargo area (for example, a pick-up truck box or bed) of 72.0 inches in interior length or more. A covered box not readily accessible from the passenger compartment will be considered an open cargo area for purposes of this definition. Minivan means a light truck which is designed primarily to carry no more than eight passengers, having an integral enclosure fully enclosing the driver, passenger, and load-carrying compartments, and rear seats readily removed, folded, stowed, or pivoted to facilitate cargo carrying. A minivan typically includes one or more sliding doors and a rear liftgate. Minivans typically have less total interior volume or overall height than full sized vans and are commonly advertised and marketed as “minivans.” Model type means a unique combination of car line, basic engine, and transmission class. Model year means the manufacturer's annual production period (as determined by the Administrator) which includes January 1 of such calendar year. If a manufacturer has no annual production period, the term “model year” means the calendar year. Motor controller means an electronic or electro-mechanical device to convert energy stored in an energy storage device into a form suitable to power the traction motor. Natural gas-fueled automobile means an automobile designed to operate exclusively on natural gas. Natural gas dual fuel automobile means an automobile: (1) Which is designed to operate on natural gas and on gasoline or diesel fuel; (2) Which provides equal or greater energy efficiency as calculated in § 600.510-08(g)(1) while operating on natural gas as it does while operating on gasoline or diesel fuel; and (3) Which, in the case of passenger automobiles, meets or exceeds the minimum driving range established by the Department of Transportation in 49 CFR part 538. Non-passenger automobile has the meaning given by the Department of Transportation at 49 CFR 523.5. This term is synonymous with “light truck.” Passenger automobile has the meaning given by the Department of Transportation at 49 CFR 523.4. Pickup truck means a nonpassenger automobile which has a passenger compartment and an open cargo bed. Plug-in hybrid electric vehicle (PHEV) has the meaning given in § 86.1803 of this chapter. Production volume means, for a domestic manufacturer, the number of vehicle units domestically produced in a particular model year but not exported, and for a foreign manufacturer, means the number of vehicle units of a particular model imported into the United States. QR Code means Quick Response Code, which is a registered trademark of Denso Wave, Incorporated. Round has the meaning given in § 1065.1001 of this chapter, unless specified otherwise. SC03 means the test procedure specified in 40 CFR 1066.801(c)(2). Secretary of Energy means the Secretary of Energy or his authorized representative. Secretary of Transportation means the Secretary of Transportation or his authorized representative. Sport utility vehicle (SUV) means a light truck with an extended roof line to increase cargo or passenger capacity, cargo compartment open to the passenger compartment, and one or more rear seats readily removed or folded to facilitate cargo carrying. Station wagon means a passenger automobile with an extended roof line to increase cargo or passenger capacity, cargo compartment open to the passenger compartment, a tailgate, and one or more rear seats readily removed or folded to facilitate cargo carrying. Subconfiguration means one of the following: (1) For LDV, LDT, and MDPV FE , subconfiguration means a unique combination within a vehicle configuration of equivalent test weight, road-load horsepower, and any other operational characteristics or parameters which the Administrator determines may significantly affect fuel economy or CO 2 emissions within a vehicle configuration. (2) For HDV, subconfiguration has the meaning given in § 86.1819-14(d)(12) of this chapter. Test weight means the weight within an inertia weight class which is used in the dynamometer testing of a vehicle, and which is based on its loaded vehicle weight in accordance with the provisions of part 86 of this chapter. Track width has the meaning given in § 86.1803 of this chapter. Transmission class means a group of transmissions having the following common features: Basic transmission type ( e.g., automatic, manual, automated manual, semi-automatic, or continuously variable); number of forward gears used in fuel economy testing ( e.g., manual four-speed, three-speed automatic, two-speed semi-automatic); drive system ( e.g., front wheel drive, rear wheel drive; four wheel drive), type of overdrive, if applicable ( e.g., final gear ratio less than 1.00, separate overdrive unit); torque converter type, if applicable ( e.g., non-lockup, lockup, variable ratio); and other transmission characteristics that may be determined to be significant by the Administrator. Transmission configuration means the Administrator may further subdivide within a transmission class if the Administrator determines that sufficient fuel economy differences exist. Features such as gear ratios, torque converter multiplication ratio, stall speed, shift calibration, or shift speed may be used to further distinguish characteristics within a transmission class. Ultimate consumer means the first person who purchases an automobile for purposes other than resale or who leases an automobile. US06 means the test procedure as described in 40 CFR 1066.801(c)(2). US06-City means the combined periods of the US06 test that occur before and after the US06-Highway period. US06-Highway means the period of the US06 test that begins at the end of the deceleration which is scheduled to occur at 130 seconds of the driving schedule and terminates at the end of the deceleration which is scheduled to occur at 495 seconds of the driving schedule. Usable fuel storage capacity means the amount of fuel that is available to a vehicle starting from a complete refueling event until the vehicle stops (or until driveability deteriorates to the point that further driving is unlikely or impractical). For liquid fuels, the usable fuel storage capacity represents the difference between the total fuel volume after a complete refueling event and the fuel volume that remains in the fuel tank after the vehicle runs out of fuel. For other fuels, use good engineering judgment to determine the full and empty conditions consistent with typical consumer behavior. For example, for natural gas vehicles, the full condition would be the point at which a typical operator would stop refueling based on the increasing system pressures, which are determined by temperature effects related to the refueling process; this does not necessarily represent the maximum amount of fuel the tank can hold under equilibrium conditions. The empty condition would be the point at which fuel pressure drops enough that the engine is unable to maintain stable air-fuel ratios for acceptable continued operation. Van means any light truck having an integral enclosure fully enclosing the driver compartment and load carrying compartment. The distance from the leading edge of the windshield to the foremost body section of vans is typically shorter than that of pickup trucks and SUVs. Vehicle configuration means one of the following: (1) For LDV, LDT, and MDPV FE , vehicle configuration means a unique combination of basic engine, engine code, inertia weight class, transmission configuration, and axle ratio within a base level. (2) For HDV, vehicle configuration has the meaning given for “configuration” in § 86.1819-14(d)(12) of this chapter. Vehicle-specific 5-cycle CO 2 means the CO 2 calculated according to the procedures in § 600.114. Vehicle-specific 5-cycle fuel economy means the fuel economy calculated according to the procedures in § 600.114. We (us, our) means the Administrator of the Environmental Protection Agency and any authorized representatives. Wheelbase has the meaning given in § 86.1803 of this chapter." 40:40:32.0.1.4.44.1.13.3,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.003 Abbreviations.,EPA,,,"[76 FR 39527, July 6, 2011]","The abbreviations and acronyms used in this part have the same meaning as those in part 86 of this chapter, with the addition of the following: (a) “MPG” or “mpg” means miles per gallon. This may be used to generally describe fuel economy as a quantity, or it may be used as the units associated with a particular value. (b) MPGe means miles per gallon equivalent. This is generally used to quantify a fuel economy value for vehicles that use a fuel other than gasoline. The value represents miles the vehicle can drive with the energy equivalent of one gallon of gasoline. (c) SCF means standard cubic feet. (d) SUV means sport utility vehicle. (e) CREE means carbon-related exhaust emissions." 40:40:32.0.1.4.44.1.13.4,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.005 Maintenance of records and rights of entry.,EPA,,,"[45 FR 49259, July 24, 1980, as amended at 64 FR 23973, May 4, 1999. Redesignated and amended at 76 FR 39524, 39527, July 6, 2011]","The provisions of this section are applicable to all fuel economy data vehicles. Certification vehicles are required to meet the provisions of § 86.1844 of this chapter. (a) The manufacturer of any new motor vehicle subject to any of the standards or procedures prescribed in this part shall establish, maintain, and retain the following adequately organized and indexed records: (1) General records. (i) Identification and description of all vehicles for which data are submitted to meet the requirements of this part. (ii) A description of all procedures used to test each vehicle. (iii) A copy of the information required to be submitted under § 600.006 fulfills the requirements of paragraph (a)(1)(i) of this section. (2) Individual records. A brief history of each vehicle for which data are submitted to meet the requirements of this part, in the form of a separate booklet or other document for each separate vehicle, in which must be recorded: (i) The steps taken to ensure that the vehicle with respect to its engine, drive train, fuel system, emission control system components, exhaust after treatment device, vehicle weight, or any other device or component, as applicable, will be representative of production vehicles. In the case of electric vehicles, the manufacturer should describe the steps taken to ensure that the vehicle with respect to its electric traction motor, motor controller, battery configuration, or any other device or component, as applicable, will be representative of production vehicles. (ii) A complete record of all emission tests performed under part 86 of this chapter, all fuel economy tests performed under this part 600 (except tests actually performed by EPA personnel), and all electric vehicle tests performed according to procedures promulgated by DOE, including all individual worksheets and other documentation relating to each such test or exact copies thereof; the date, time, purpose, and location of each test; the number of miles accumulated on the vehicle when the tests began and ended; and the names of supervisory personnel responsible for the conduct of the tests. (iii) A description of mileage accumulated since selection of buildup of such vehicles including the date and time of each mileage accumulation listing both the mileage accumulated and the name of each driver, or each operator of the automatic mileage accumulation device, if applicable. Additionally, a description of mileage accumulated prior to selection or buildup of such vehicle must be maintained in such detail as is available. (iv) If used, the record of any devices employed to record the speed or mileage, or both, of the test vehicle in relationship to time. (v) A record and description of all maintenance and other servicing performed, within 2,000 miles prior to fuel economy testing under this part, giving the date and time of the maintenance or service, the reason for it, the person authorizing it, and the names of supervisory personnel responsible for the conduct of the maintenance or service. A copy of the maintenance information to be submitted under § 600.006 fulfills the requirements of this paragraph (a)(2)(v). (vi) A brief description of any significant events affecting the vehicle during any of the period covered by the history not described in an entry under one of the previous headings including such extraordinary events as vehicle accidents or driver speeding citations or warnings. (3) Keeping records. The manufacturer shall retain all records required under this part for five years after the end of the model year to which they relate. Records may be retained as hard copy or some alternative storage medium, provided that in every case all the information contained in hard copy shall be retained. (b)(1) Any manufacturer who has supplied fuel economy data to meet the requirements of this part shall admit any EPA Enforcement Officer during operating hours upon presentation of credentials at any of the following: (i) Any facility where any fuel economy tests from which data are submitted or any procedures or activities connected with these tests are performed. (ii) Any facility where any new motor vehicle which is being, was, or is to be tested is present. (iii) Any facility where any construction process used in the modification or buildup of a vehicle into a fuel economy data vehicle is taking place or has taken place. (iv) Any facility where any record or other document relating to any of the above is located. (2) Upon admission to any facility referred to in paragraph (b)(1) of this section, the manufacturer shall allow any EPA Enforcement Officer: (i) To inspect and monitor any part or aspect of procedures, activities, and testing facilities, including, but not limited to, monitoring vehicle preconditioning; emission and fuel economy tests and mileage accumulation; maintenance; vehicle soak and storage procedures; and to verify correlation of calibration of test equipment; (ii) To inspect and make copies of any required records, designs, or other documents; and (iii) To inspect and photograph any part or aspect of any fuel economy vehicle and any components to be used in the construction thereof. (3) Any EPA Enforcement Officer will be furnished, by those in charge of facility being inspected, with such reasonable assistance as may be required to help discharge any function listed in this paragraph (b). Each manufacturer is required to have those in charge of the facility furnish such reasonable assistance without charge to EPA whether or not the manufacturer controls the facility. (4) The duty to admit any EPA Enforcement Officer shall be applicable whether or not the manufacturer owns or controls the facility in question and is applicable to both domestic and foreign manufacturers and facilities. An EPA Enforcement Officer will not attempt to make any inspections which the officer has been informed are in contravention of any law. However, if local law makes it impossible for the EPA Enforcement Officer to verify or to ensure the accuracy of data generated at a facility such that no informed judgment can properly be made as to the accuracy or reliability of data generated by or obtained for the facility, then a vehicle or data from that vehicle shall not be accepted for use in subpart C or F of this part (unless the Administrator is otherwise convinced of the accuracy and reliability of such data). (5) For purposes of this paragraph (b): (i) “Presentation of credentials” means display of the document designating a person as an EPA Enforcement Officer. (ii) Where vehicle, component, or engine storage areas or facilities are concerned, “operating hours” shall mean all times during which personnel other than custodial personnel are at work in the vicinity of the area or facility and have access to it. (iii) For facilities or areas other than those covered by paragraph (b)(5)(ii) of this section, the term, “operating hours” will mean all times during which an assembly line is in operation or all times during which testing, maintenance, mileage accumulation, production or compilation of records, or any other procedure or activity related to fuel economy testing, or to vehicle manufacturer or assembly, is being carried out in a facility. (iv) “Reasonable assistance” means providing timely and unobstructed access to and opportunity for the copying of any record, book, paper, or document required to be maintained under this section and providing timely and unobstructed access to any motor vehicle, testing facility, or testing equipment. (v) Any entry without 24 hours prior written or oral notification to the affected manufacturer shall be authorized in writing by the Assistant Administrator for Enforcement." 40:40:32.0.1.4.44.1.13.5,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.006 Data and information requirements for fuel economy data vehicles.,EPA,,,"[71 FR 77929, Dec. 27, 2006, as amended at 75 FR 25702, May 7, 2010. Redesignated and amended at 76 FR 39524, 39528, July 6, 2011]","(a) For certification vehicles with less than 10,000 miles, the requirements of this section are considered to have been met except as noted in paragraph (c) of this section. (b)(1) The manufacturer shall submit the following information for each fuel economy data vehicle: (i) A description of the vehicle, exhaust emission test results, applicable deterioration factors, adjusted exhaust emission levels, and test fuel property values as specified in § 600.113-08. (ii) A statement of the origin of the vehicle including total mileage accumulation, and modification (if any) form the vehicle configuration in which the mileage was accumulated. (For modifications requiring advance approval by the Administrator, the name of the Administrator's representative approving the modification and date of approval are required.) If the vehicle was previously used for testing for compliance with part 86 of this chapter or previously accepted by the Administrator as a fuel economy data vehicle in a different configuration, the requirements of this paragraph may be satisfied by reference to the vehicle number and previous configuration. (iii) A statement that the fuel economy data vehicle for which data are submitted: (A) Has been tested in accordance with applicable test procedures; (B) Is, to the best of the manufacturer's knowledge, representative of the vehicle configuration listed; and (C) Is in compliance with applicable exhaust emission standards. (2) The manufacturer shall retain the following information for each fuel economy data vehicle, and make it available to the Administrator upon request: (i) A description of all maintenance to engine, emission control system, or fuel system, or fuel system components performed within 2,000 miles prior to fuel economy testing. (ii) In the case of electric vehicles, plug-in hybrid electric vehicles, and hybrid electric vehicles, a description of all maintenance to electric motor, motor controller, battery configuration, or other components performed within 2,000 miles prior to fuel economy testing. (iii) A copy of calibrations for engine, fuel system, and emission control devices, showing the calibration of the actual components on the test vehicle as well as the design tolerances. (iv) In the case of electric vehicles, plug-in hybrid electric vehicles, and hybrid electric vehicles, a copy of calibrations for the electric motor, motor controller, battery configuration, or other components on the test vehicle as well as the design tolerances. (v) If calibrations for components specified in paragraph (b)(2) (iii) or (iv) of this section were submitted previously as part of the description of another vehicle or configuration, the original submittal may be referenced. (c) The manufacturer shall submit the following fuel economy data: (1) For vehicles tested to meet the requirements of part 86 of this chapter (other than those chosen in accordance with the provisions related to durability demonstration in § 86.1829 of this chapter or in-use verification testing in § 86.1845 of this chapter), the FTP, highway, US06, SC03 and cold temperature FTP fuel economy results, as applicable, from all tests on that vehicle, and the test results adjusted in accordance with paragraph (g) of this section. (2) For each fuel economy data vehicle, all individual test results (excluding results of invalid and zero mile tests) and these test results adjusted in accordance with paragraph (g) of this section. (3) For diesel vehicles tested to meet the requirements of part 86 of this chapter, data from a cold temperature FTP, performed in accordance with § 600.111-08(e), using the fuel specified in § 600.107-08(c). (4) For all vehicles tested in paragraph (c)(1) through (3) of this section, the individual fuel economy results measured on a per-phase basis, that is, the individual phase results for all sample phases of the FTP, cold temperature FTP and US06 tests. (5) Starting with the 2012 model year, the data submitted according to paragraphs (c)(1) through (4) of this section shall include total HC, CO, CO 2 , and, where applicable for alternative fuel vehicles, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC and CH 4 . Manufacturers incorporating N 2 O and CH 4 emissions in their fleet average carbon-related exhaust emissions as allowed under § 86.1818 of this chapter shall also submit N 2 O and CH 4 emission data where applicable. The fuel economy, carbon-related exhaust emissions, and CO 2 emission test results shall be adjusted in accordance with paragraph (g) of this section. (d) The manufacturer shall submit an indication of the intended purpose of the data (e.g., data required by the general labeling program or voluntarily submitted for specific labeling). (e) In lieu of submitting actual data from a test vehicle, a manufacturer may provide fuel economy, CO 2 emissions, and carbon-related exhaust emission values derived from a previously tested vehicle, where the fuel economy, CO 2 emissions, and carbon-related exhaust emissions are expected to be equivalent (or less fuel-efficient and with higher CO 2 emissions and carbon-related exhaust emissions). Additionally, in lieu of submitting actual data from a test vehicle, a manufacturer may provide fuel economy, CO 2 emissions, and carbon-related exhaust emission values derived from an analytical expression, e.g., regression analysis. In order for fuel economy, CO 2 emissions, and carbon-related exhaust emission values derived from analytical methods to be accepted, the expression (form and coefficients) must have been approved by the Administrator. (f) If, in conducting tests required or authorized by this part, the manufacturer utilizes procedures, equipment, or facilities not described in the Application for Certification required in § 86.1844-01 of this chapter, the manufacturer shall submit to the Administrator a description of such procedures, equipment, and facilities. (g)(1) The manufacturer shall adjust all test data used for fuel economy label calculations in subpart D and average fuel economy calculations in subpart F for the classes of automobiles within the categories identified in paragraphs of § 600.510(a)(1) through (4). The test data shall be adjusted in accordance with paragraph (g)(3) or (4) of this section as applicable. (2) [Reserved] (3)(i) The manufacturer shall adjust all fuel economy test data generated by vehicles with engine-drive system combinations with more than 6,200 miles by using the following equation: FE 4,000mi = FE T [0.979 + 5.25 × 10 −6 (mi)] −1 Where: FE 4,000mi = Fuel economy data adjusted to 4,000-mile test point rounded to the nearest 0.1 mpg. FE T = Tested fuel economy value rounded to the nearest 0.1 mpg. mi = System miles accumulated at the start of the test rounded to the nearest whole mile. Where: FE 4,000mi = Fuel economy data adjusted to 4,000-mile test point rounded to the nearest 0.1 mpg. FE T = Tested fuel economy value rounded to the nearest 0.1 mpg. mi = System miles accumulated at the start of the test rounded to the nearest whole mile. (ii)(A) The manufacturer shall adjust all carbon-related exhaust emission (CREE) and all CO 2 test data generated by vehicles with engine-drive system combinations with more than 6,200 miles by using the following equation: ADJ 4,000mi = TEST[0.979 + 5.25 · 10 −6 · (mi)] Where: ADJ 4,000mi = CREE or CO 2 emission data adjusted to 4,000-mile test point. TEST = Tested emissions value of CREE or CO 2 in grams per mile. mi = System miles accumulated at the start of the test rounded to the nearest whole mile. Where: ADJ 4,000mi = CREE or CO 2 emission data adjusted to 4,000-mile test point. TEST = Tested emissions value of CREE or CO 2 in grams per mile. mi = System miles accumulated at the start of the test rounded to the nearest whole mile. (B) Emissions test values and results used and determined in the calculations in this paragraph (g)(3)(ii) shall be rounded in accordance with § 86.1837 of this chapter as applicable. CO 2 and CREE values shall be rounded to the nearest gram per mile. (C) Note that the CREE test results are determined using the unadjusted CO 2 value; i.e., CO 2 is not adjusted twice when determining the 4,000 mile CREE value. (4) For vehicles with 6,200 miles or less accumulated, the manufacturer is not required to adjust the data. (5) The Administrator may specify a different adjustment calculation for electric vehicles, plug-in hybrid electric vehicles, and fuel cell vehicles to allow for properly characterizing the fuel economy and emissions of these vehicles." 40:40:32.0.1.4.44.1.13.6,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.007 Vehicle acceptability.,EPA,,,"[71 FR 77930, Dec. 27, 2006, as amended at 75 FR 25703, May 7, 2010. Redesignated and amended at 76 FR 39524, 39529, July 6, 2011; 89 FR 28201, Apr. 18, 2024]","(a) All certification vehicles and other vehicles tested to meet the requirements of part 86 of this chapter (other than those chosen under the durability-demonstration provisions in § 86.1829 of this chapter), are considered to have met the requirements of this section. (b) Any vehicle not meeting the provisions of paragraph (a) of this section must be judged acceptable by the Administrator under this section in order for the test results to be reviewed for use in subpart C or F of this part. The Administrator will judge the acceptability of a fuel economy data vehicle on the basis of the information supplied by the manufacturer under § 600.006(b). The criteria to be met are: (1) A fuel economy data vehicle may have accumulated not more than 10,000 miles. A vehicle will be considered to have met this requirement if the engine and drivetrain have accumulated 10,000 or fewer miles. The Administrator may specify a different maximum value for electric vehicles, plug-in hybrid electric vehicles, and fuel cell vehicles that allows for the necessary operation for properly evaluating and characterizing those vehicles under this part. The components installed for a fuel economy test are not required to be the ones with which the mileage was accumulated, e.g., axles, transmission types, and tire sizes may be changed. The Administrator will determine if vehicle/engine component changes are acceptable. (2) A vehicle may be tested in different vehicle configurations by change of vehicle components, as specified in paragraph (b)(1) of this section, or by testing in different inertia weight classes. Also, a single vehicle may be tested under different test conditions, i.e., test weight and/or road load horsepower, to generate fuel economy data representing various situations within a vehicle configuration. For purposes of this part, data generated by a single vehicle tested in various test conditions will be treated as if the data were generated by the testing of multiple vehicles. (3) The mileage on a fuel economy data vehicle must be, to the extent possible, accumulated according to § 86.1831 of this chapter. (4) Each fuel economy data vehicle must meet the same exhaust emission standards as certification vehicles of the respective engine-system combination during the test in which the fuel economy test results are generated. This may be demonstrated using one of the following methods: (i) The deterioration factors established for the respective engine-system combination per § 86.1841 of this chapter as applicable will be used; or (ii) The fuel economy data vehicle will be equipped with aged emission control components according to the provisions of § 86.1823 of this chapter. (5) The calibration information submitted under § 600.006(b) must be representative of the vehicle configuration for which the fuel economy, CO 2 emissions, and carbon-related exhaust emissions data were submitted. (6) Any vehicle tested for fuel economy, CO 2 emissions, or carbon-related exhaust emissions purposes must be representative of a vehicle which the manufacturer intends to produce under the provisions of a certificate of conformity. (7) For vehicles imported under § 85.1509 or § 85.1511(b)(2), (b)(4), (c)(1), (c)(2) or (d) of this chapter (when applicable), only the following requirements must be met: (i) For vehicles imported under § 85.1509 of this chapter, a highway fuel economy value must be generated contemporaneously with the emission tests used for purposes of demonstrating compliance with § 85.1509 of this chapter. No modifications or adjustments should be made to the vehicles between the highway fuel economy, FTP, US06, SC03 and Cold temperature FTP tests. (ii) For vehicles imported under § 85.1509 or § 85.1511(b)(2), (b)(4), (c)(1), or (c)(2) of this chapter (when applicable) with over 10,000 miles, the equation in § 600.006(g)(3) shall be used as though only 10,000 miles had been accumulated. (iii) Any required fuel economy testing must take place after any safety modifications are completed for each vehicle as required by regulations of the Department of Transportation. (iv) Every vehicle imported under § 85.1509 or § 85.1511(b)(2), (b)(4), (c)(1), or (c)(2) of this chapter (when applicable) must be considered a separate type for the purposes of calculating a fuel economy label for a manufacturer's average fuel economy. (c) If, based on review of the information submitted under § 600.006(b), the Administrator determines that a fuel economy data vehicle meets the requirements of this section, the fuel economy data vehicle will be judged to be acceptable and fuel economy and carbon-related exhaust emissions data from that fuel economy data vehicle will be reviewed pursuant to § 600.008. (d) If, based on the review of the information submitted under § 600.006(b), the Administrator determines that a fuel economy data vehicle does not meet the requirements of this section, the Administrator will reject that fuel economy data vehicle and inform the manufacturer of the rejection in writing. (e) If, based on a review of the emission data for a fuel economy data vehicle, submitted under § 600.006(b), or emission data generated by a vehicle tested under § 600.008(e), the Administrator finds an indication of non-compliance with section 202 of the Clean Air Act, 42 U.S.C. 1857 et seq. of the regulation thereunder, he may take such investigative actions as are appropriate to determine to what extent emission non-compliance actually exists. (1) The Administrator may, under the provisions of § 86.1830 of this chapter, request the manufacturer to submit production vehicles of the configuration(s) specified by the Administrator for testing to determine to what extent emission noncompliance of a production vehicle configuration or of a group of production vehicle configurations may actually exist. (2) If the Administrator determines, as a result of his investigation, that substantial emission non-compliance is exhibited by a production vehicle configuration or group of production vehicle configurations, he may proceed with respect to the vehicle configuration(s) as provided under section 206 or 207, as applicable, of the Clean Air Act, 42 U.S.C. 1857 et seq. (f) All vehicles used to generate fuel economy and carbon-related exhaust emissions data, and for which emission standards apply, must be covered by a certificate of conformity under part 86 of this chapter before: (1) The data may be used in the calculation of any approved general or specific label value, or (2) The data will be used in any calculations under subpart F, except that vehicles imported under §§ 85.1509 and 85.1511 of this chapter need not be covered by a certificate of conformity." 40:40:32.0.1.4.44.1.13.7,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,"§ 600.008 Review of fuel economy, CO",EPA,,,"[71 FR 77931, Dec. 27, 2006, as amended at 75 FR 25703, May 7, 2010. Redesignated and amended at 76 FR 39524, 39529, July 6, 2011; 89 FR 28201, Apr. 18, 2024]","(a) Testing by the Administrator. (1)(i) The Administrator may require that any one or more of the test vehicles be submitted to the Agency, at such place or places as the Agency may designate, for the purposes of conducting fuel economy tests. The Administrator may specify that such testing be conducted at the manufacturer's facility, in which case instrumentation and equipment specified by the Administrator shall be made available by the manufacturer for test operations. The tests to be performed may comprise the FTP, highway fuel economy test, US06, SC03, or Cold temperature FTP or any combination of those tests. Any testing conducted at a manufacturer's facility pursuant to this paragraph shall be scheduled by the manufacturer as promptly as possible. (ii) Starting with the 2012 model year for carbon-related exhaust emissions and with the 2013 model year for CO 2 emissions, the evaluations, testing, and test data described in this section pertaining to fuel economy shall also be performed for CO 2 emissions and carbon-related exhaust emissions, except that CO 2 emissions and carbon-related exhaust emissions shall be arithmetically averaged instead of harmonically averaged, and in cases where the manufacturer selects the lowest of several fuel economy results to represent the vehicle, the manufacturer shall select the CO 2 emissions and carbon-related exhaust emissions value from the test results associated with the lowest selected fuel economy results. (2) Retesting and official data determination. For any vehicles selected for confirmatory testing under the provisions of paragraph (a)(1) of this section, the Administrator will follow this procedure: (i) The manufacturer's fuel economy data (or harmonically averaged data if more than one test was conducted) will be compared with the results of the Administrator's test. (ii) If, in the Administrator's judgment, the comparison in paragraph (a)(2)(i) of this section indicates a disparity in the data, the Administrator will repeat the test or tests as applicable. (A) The manufacturer's average test results and the results of the Administrator's first test will be compared with the results of the Administrator's second test as in paragraph (a)(2)(i) of this section. (B) If, in the Administrator's judgment, both comparisons in paragraph (a)(2)(i)(A) of this section, indicate a disparity in the data, the Administrator will repeat the applicable test or tests until: ( 1 ) In the Administrator's judgment no disparity in the data is indicated by comparison of two tests by the Administrator or by comparison of the manufacturer's average test results and a test by the Administrator; or ( 2 ) Four tests of a single test type are conducted by the Administrator in which a disparity in the data is indicated when compared as in paragraph (a)(2)(ii) of this section. (iii) If there is, in the Administrator's judgment, no disparity indicated by comparison of manufacturer's average test results with a test by the Administrator, the test values generated by the Administrator will be used to represent the vehicle. (iv) If there is, in the Administrator's judgment, no disparity indicated by comparison of two tests by the Administrator, the harmonic averages of the fuel economy results from those tests will be used to represent the vehicle. (v) If the situation in paragraph (a)(2)(ii)(B)( 2 ) of this section occurs, the Administrator will notify the manufacturer, in writing, that the Administrator rejects that fuel economy data vehicle. (b) Manufacturer-conducted confirmatory testing. (1) If the Administrator determines not to conduct a confirmatory test under the provisions of paragraph (a) of this section, manufacturers will conduct a confirmatory test at their facility after submitting the original test data to the Administrator whenever any of the following conditions exist: (i) The vehicle configuration has previously failed an emission standard; (ii) The test exhibits high emission levels determined by exceeding a percentage of the standards specified by the Administrator for that model year; (2) If the Administrator selects the vehicle for confirmatory testing based on the manufacturer's original test results, the testing shall be conducted as ordered by the Administrator. In this case, the manufacturer-conducted confirmatory testing specified under paragraph (b)(1) of this section would not be required. (3) The manufacturer shall conduct a retest of the FTP or highway test if the difference between the fuel economy of the confirmatory test and the original manufacturer's test equals or exceeds three percent (or such lower percentage to be applied consistently to all manufacturer-conducted confirmatory testing as requested by the manufacturer and approved by the Administrator). (i) The manufacturer may, in lieu of conducting a retest, accept the lower of the original and confirmatory test fuel economy results for use in subpart C or F of this part. (ii) The manufacturer shall conduct a second retest of the FTP or highway test if the fuel economy difference between the second confirmatory test and the original manufacturer test equals or exceeds three percent (or such lower percentage as requested by the manufacturer and approved by the Administrator) and the fuel economy difference between the second confirmatory test and the first confirmatory test equals or exceeds three percent (or such lower percentage as requested by the manufacturer and approved by the Administrator). The manufacturer may, in lieu of conducting a second retest, accept the lowest of the original test, the first confirmatory test, and the second confirmatory test fuel economy results for use in subpart C or F of this part. (4) The Administrator may request the manufacturer to conduct a retest of the US06, SC03 or Cold Temperature FTP on the basis of fuel economy that is higher than expected as specified in criteria provided by the Administrator. Such retests shall not be required before the 2011 model year. (c) Review of fuel economy data. (1) Fuel economy data must be judged reasonable and representative by the Administrator in order for the test results to be used for the purposes of subpart C or F of this part. In making this determination, the Administrator will, when possible, compare the results of a test vehicle to those of other similar test vehicles. (2) If testing was conducted by the Administrator under the provisions of paragraph (a) of this section, the data from this testing, together with all other fuel economy data submitted for that vehicle under § 600.006(c) or (e) will be evaluated by the Administrator for reasonableness and representativeness per paragraph (c)(1) of this section. (i) The fuel economy data which are determined to best meet the criteria of paragraph (c)(1) of this section will be accepted for use in subpart C or F of this part. (ii) City, HFET, US06, SC03 and Cold temperature FTP test data will be considered separately. (iii) If more than one test was conducted, the Administrator may select an individual test result or the harmonic average of selected test results to satisfy the requirements of paragraph (c)(2)(i) of this section. (3) If confirmatory testing was conducted by the manufacturer under the provisions of paragraph (b) of this section, the data from this testing will be evaluated by the Administrator for reasonableness and representativeness per paragraph (c)(1) of this section. (i) The fuel economy data which are determined to best meet the criteria of paragraph (c)(1) of this section will be accepted for use in subpart C or F of this part. (ii) City, HFET, US06, SC03 and Cold temperature FTP test data will be considered separately. (iii) If more than one test was conducted, the Administrator may select an individual test result or the harmonic average of selected test results to satisfy the requirements of paragraph (c)(2)(i) of this section. (4) If no confirmatory testing was conducted by either the Administrator or the manufacturer under the provisions of paragraph (a) and (b) of this section, respectively, then the data submitted under the provisions of § 600.006(c) or (e) shall be accepted for use in subpart C or F of this part. (i) City, HFET, US06, SC03 and Cold temperature FTP test data will be considered separately. (ii) If more than one test was conducted, the harmonic average of the test results shall be accepted for use in subpart C or F of this part. (d) If, based on a review of the fuel economy data generated by testing under paragraph (a) of this section, the Administrator determines that an unacceptable level of correlation exists between fuel economy data generated by a manufacturer and fuel economy data generated by the Administrator, he/she may reject all fuel economy data submitted by the manufacturer until the cause of the discrepancy is determined and the validity of the data is established by the manufacturer. (e)(1) If, based on the results of an inspection conducted under § 600.005(b) or any other information, the Administrator has reason to believe that the manufacturer has not followed proper testing procedures or that the testing equipment is faulty or improperly calibrated, or if records do not exist that will enable him to make a finding of proper testing, the Administrator may notify the manufacturer in writing of his finding and require the manufacturer to: (i) Submit the test vehicle(s) upon which the data are based or additional test vehicle(s) at a place he may designate for the purpose of fuel economy testing. (ii) Conduct such additional fuel economy testing as may be required to demonstrate that prior fuel economy test data are reasonable and representative. (2) Previous acceptance by the Administrator of any fuel economy test data submitted by the manufacturer shall not limit the Administrator's right to require additional testing under paragraph (e)(1) of this section. (3) If, based on tests required under paragraph (e)(1) of this section, the Administrator determines that any fuel economy data submitted by the manufacturer and used to calculate the manufacturer's fuel economy average was unrepresentative, the Administrator may recalculate the manufacturer's fuel economy average based on fuel economy data that he/she deems representative. (4) A manufacturer may request a hearing as provided in § 600.009 if the Administrator decides to recalculate the manufacturer's average pursuant to determinations made relative to this section." 40:40:32.0.1.4.44.1.13.8,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.009 Hearing on acceptance of test data.,EPA,,,"[76 FR 39530, July 6, 2011]","(a) The manufacturer may request a hearing on the Administrator's decision if the Administrator rejects any of the following: (1) The use of a manufacturer's fuel economy data vehicle, in accordance with § 600.008(e) or (g), or (2) The use of fuel economy data, in accordance with § 600.008(c), or (f), or (3) The determination of a vehicle configuration, in accordance with § 600.206(a), or (4) The identification of a car line, in accordance with § 600.002, or (5) The fuel economy label values determined by the manufacturer under § 600.312-08(a), then: (b) The request for a hearing must be filed in writing within 30 days after being notified of the Administrator's decision. The request must be signed by an authorized representative of the manufacturer and include a statement specifying the manufacturer's objections to the Administrator's determinations, with data in support of such objection. (c) If, after the review of the request and supporting data, the Administrator finds that the request raises one or more substantial factual issues, the Administrator shall provide the manufacturer with a hearing in accordance with the provisions of 40 CFR part 1068, subpart G. (d) A manufacturer's use of any fuel economy data which the manufacturer challenges pursuant to this section shall not constitute final acceptance by the manufacturer nor prejudice the manufacturer in the exercise of any appeal pursuant to this section challenging such fuel economy data." 40:40:32.0.1.4.44.1.13.9,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,A,Subpart A—General Provisions,,§ 600.010 Vehicle test requirements and minimum data requirements.,EPA,,,"[71 FR 77932, Dec. 27, 2006, as amended at 74 FR 61549, Nov. 25, 2009; 75 FR 25703, May 7, 2010. Redesignated and amended at 76 FR 39524, 39530, July 6, 2011]","(a) Unless otherwise exempted from specific emission compliance requirements, for each certification vehicle defined in this part, and for each vehicle tested according to the emission test procedures in part 86 of this chapter for addition of a model after certification or approval of a running change (§ 86.1842 of this chapter, as applicable): (1) The manufacturer shall generate FTP fuel economy data by testing according to the applicable procedures. (2) The manufacturer shall generate highway fuel economy data by: (i) Testing according to applicable procedures, or (ii) Using an analytical technique, as described in § 600.006(e). (3) The manufacturer shall generate US06 fuel economy data by testing according to the applicable procedures. Alternate fueled vehicles or dual fueled vehicles operating on alternate fuel may optionally generate this data using the alternate fuel. (4) The manufacturer shall generate SC03 fuel economy data by testing according to the applicable procedures. Alternate fueled vehicles or dual fueled vehicles operating on alternate fuel may optionally generate this data using the alternate fuel. (5) The manufacturer shall generate cold temperature FTP fuel economy data by testing according to the applicable procedures. Alternate fueled vehicles or dual fueled vehicles operating on alternate fuel may optionally generate this data using the alternate fuel. (6) The data generated in paragraphs (a)(1) through (5) of this section, shall be submitted to the Administrator in combination with other data for the vehicle required to be submitted in part 86 of this chapter. (b) For each fuel economy data vehicle: (1) The manufacturer shall generate FTP and HFET fuel economy data by: (i) Testing according to applicable procedures, or (ii) Use of an analytical technique as described in § 600.006(e), in addition to testing (e.g., city fuel economy data by testing, highway fuel economy data by analytical technique). (2) The data generated shall be submitted to the Administrator according to the procedures in § 600.006. (c) Minimum data requirements for labeling. (1) In order to establish fuel economy label values under § 600.301, the manufacturer shall use only test data accepted in accordance with § 600.008 meeting the minimum coverage of: (i) Data required for emission certification under §§ 86.1828 and 86.1842 of this chapter. (ii)(A) FTP and HFET data from the highest projected model year sales subconfiguration within the highest projected model year sales configuration for each base level, and (B) If required under § 600.115, for 2011 and later model year vehicles, US06, SC03 and cold temperature FTP data from the highest projected model year sales subconfiguration within the highest projected model year sales configuration for each base level. Manufacturers may optionally generate this data for any 2008 through 2010 model years, and, 2011 and later model year vehicles, if not otherwise required. (iii) For additional model types established under § 600.208-08(a)(2), § 600.208-12(a)(2) § 600.209-08(a)(2), or § 600.209-12(a)(2) FTP and HFET data, and if required under § 600.115, US06, SC03 and Cold temperature FTP data from each subconfiguration included within the model type. (2) For the purpose of recalculating fuel economy label values as required under § 600.314-08(b), the manufacturer shall submit data required under § 600.507. (d) Minimum data requirements for the manufacturer's average fuel economy and average carbon-related exhaust emissions. For the purpose of calculating the manufacturer's average fuel economy and average carbon-related exhaust emissions under § 600.510, the manufacturer shall submit FTP (city) and HFET (highway) test data representing at least 90 percent of the manufacturer's actual model year production, by configuration, for each category identified for calculation under § 600.510-08(a) or § 600.510-12(a)(1)." 40:40:32.0.1.4.44.2.13.1,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.101 Testing overview.,EPA,,,"[89 FR 28201, Apr. 18, 2024]","Perform testing under this part as described in § 600.111. This involves the following specific requirements: (a) Perform the following tests and calculations for LDV, LDT, and MDPV FE : (1) Testing to demonstrate compliance with Corporate Average Fuel Economy standards and greenhouse gas emission standards generally involves a combination of two cycles—the Federal Test Procedure and the Highway Fuel Economy Test (see 40 CFR 1066.801). Testing to determine values for fuel economy labeling under subpart D of this part generally involves testing with three additional test cycles; § 600.210 describes circumstances in which testing with these additional test cycles does not apply for labeling purposes. (2) Calculate fuel economy and CREE values for vehicle subconfigurations, configurations, base levels, and model types as described in §§ 600.206 and 600.208. Calculate fleet average values for fuel economy and CREE as described in § 600.510. (3) Determine fuel economy values for labeling as described in § 600.210 using either the vehicle-specific 5-cycle method or the derived 5-cycle method as described in § 600.115. (i) For vehicle-specific 5-cycle labels, the test vehicle (subconfiguration) data are adjusted to better represent in-use fuel economy and CO 2 emissions based on the vehicle-specific equations in § 600.114. Sections 600.207 and 600.209 describe how to use the “adjusted” city and highway subconfiguration values to calculate adjusted values for the vehicle configuration, base level, and the model type. These “adjusted” city, highway, and combined fuel economy estimates and the combined CO 2 emissions for the model type are shown on fuel economy labels. (ii) For derived 5-cycle labels, calculate “unadjusted” fuel economy and CO 2 values for vehicle subconfigurations, configurations, base levels, and model types as described in §§ 600.206 and 600.208. Section 600.210 describes how to use the unadjusted model type values to calculate “adjusted” model type values for city, highway, and combined fuel economy and CO 2 emissions using the derived 5-cycle equations for the fuel economy label. (4) Diesel-fueled Tier 3 vehicles are not subject to cold temperature emission standards; however, you must test at least one vehicle in each test group over the cold temperature FTP to comply with requirements of this part. This paragraph (a)(4) does not apply for Tier 4 vehicles. (b) Perform the following tests and calculations for all chassis-tested vehicles other than LDV, LDT, and MDPV FE that are subject to standards under 40 CFR part 86, subpart S: (1) Test vehicles as described in 40 CFR 86.1811, 86.1816, and 86.1819. Testing to demonstrate compliance with CO 2 emission standards generally involves a combination of two cycles for each test group—the Federal Test Procedure and the Highway Fuel Economy Test (see 40 CFR 1066.801). Fuel economy labeling requirements do not apply for vehicles above 8,500 pounds GVWR, except for MDPV FE . (2) Determine fleet average CO 2 emissions as described in 40 CFR 86.1819-14(d)(9). These CO 2 emission results are used to calculate corresponding fuel consumption values to demonstrate compliance with fleet average fuel consumption standards under 49 CFR part 535. (c) Manufacturers must use E10 gasoline test fuel as specified in 40 CFR 1065.710(b) for new testing to demonstrate compliance with all emission standards and to determine fuel economy values. This requirement starts in model year 2027. Interim provisions related to test fuel apply as described in § 600.117." 40:40:32.0.1.4.44.2.13.2,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.107-08 Fuel specifications.,EPA,,,"[76 FR 39531, July 6, 2011]","(a) The test fuel specifications for gasoline, diesel, methanol, and methanol-petroleum fuel mixtures are given in § 86.113 of this chapter, except for cold temperature FTP fuel requirements for diesel and alternative fuel vehicles, which are given in paragraph (b) of this section. (b)(1) Diesel test fuel used for cold temperature FTP testing must comprise a winter-grade diesel fuel as specified in ASTM D975 (incorporated by reference in § 600.011). Alternatively, EPA may approve the use of a different diesel fuel, provided that the level of kerosene added shall not exceed 20 percent. (2) The manufacturer may request EPA approval of the use of an alternative fuel for cold temperature FTP testing. (c) Test fuels representing fuel types for which there are no specifications provided in § 86.113 of this chapter may be used if approved in advance by the Administrator." 40:40:32.0.1.4.44.2.13.3,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.111-08 Test procedures.,EPA,,,"[79 FR 23746, Apr. 28, 2014, as amended at 88 FR 4481, Jan. 24, 2023]","This section describes test procedures for the FTP, highway fuel economy test (HFET), US06, SC03, and the cold temperature FTP tests. See 40 CFR 1066.801(c) for an overview of these procedures. Perform testing according to test procedures and other requirements contained in this part 600 and in 40 CFR part 1066. This testing includes specifications and procedures for equipment, calibrations, and exhaust sampling. Manufacturers may use data collected according to previously published test procedures for model years through 2021. In addition, we may approve the use of previously published test procedures for later model years as an alternative procedure under 40 CFR 1066.10(c). Manufacturers must comply with regulatory requirements during the transition as described in 40 CFR 86.101 and 86.201. (a) FTP testing procedures. Conduct FTP testing as described in 40 CFR 1066.810 through 1066.820. You may omit evaporative emission measurements for testing under this part 600 unless we specifically require it. (b) Highway fuel economy testing procedures. Conduct HFET testing as described in 40 CFR 1066.840. (c) US06 testing procedures. Conduct US06 testing as described in 40 CFR 1066.830 and 1066.831. (d) SC03 testing procedures. Conduct SC03 testing as described in 40 CFR 1066.830 and 835. (e) Cold temperature FTP procedures. Conduct cold temperature FTP testing as described in 40 CFR part 1066, subpart H. (f) Testing with alternative fuels. For vehicles designed to operate on an alternative fuel in addition to gasoline or diesel fuel, perform FTP and HFET testing as described in paragraphs (a) and (b) of this section for each type of fuel on which the vehicle is designed to operate. No US06, SC03, or cold temperature FTP testing is required on the alternative fuel. (g) Testing for vehicles with rechargeable energy storage systems. Test electric vehicles and hybrid electric vehicles as described in § 600.116. (h) Special test procedures. We may allow or require you to use procedures other than those specified in this section as described in 40 CFR 1066.10(c). For example, special test procedures may be used for advanced technology vehicles, including, but not limited to fuel cell vehicles, hybrid electric vehicles using hydraulic energy storage, and vehicles equipped with hydrogen internal combustion engines. Additionally, we may conduct fuel economy and carbon-related exhaust emission testing using the special test procedures approved for a specific vehicle." 40:40:32.0.1.4.44.2.13.4,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,"§ 600.113-12 Fuel economy, CO",EPA,,,"[76 FR 39533, July 6, 2011, as amended at 77 FR 63179, Oct. 15, 2012; 81 FR 74000, Oct. 25, 2016; 85 FR 25271, Apr. 30, 2020; 88 FR 4481, Jan. 24, 2023; 89 FR 28202, Apr. 18, 2024]","The Administrator will use the calculation procedure set forth in this section for all official EPA testing of vehicles fueled with gasoline, diesel, alcohol-based or natural gas fuel. The calculations of the weighted fuel economy and carbon-related exhaust emission values require input of the weighted grams/mile values for total hydrocarbons (HC), carbon monoxide (CO), and carbon dioxide (CO 2 ); and, additionally for methanol-fueled automobiles, methanol (CH 3 OH) and formaldehyde (HCHO); and, additionally for ethanol-fueled automobiles, methanol (CH 3 OH), ethanol (C 2 H 5 OH), acetaldehyde (C 2 H 4 O), and formaldehyde (HCHO); and additionally for natural gas-fueled vehicles, non-methane hydrocarbons (NMHC) and methane (CH 4 ). For manufacturers selecting the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter the calculations of the carbon-related exhaust emissions require the input of grams/mile values for nitrous oxide (N 2 O) and methane (CH 4 ). Emissions shall be determined for the FTP, HFET, US06, SC03, and cold temperature FTP tests. Additionally, the specific gravity, carbon weight fraction and net heating value of the test fuel must be determined. The FTP, HFET, US06, SC03, and cold temperature FTP fuel economy and carbon-related exhaust emission values shall be calculated as specified in this section. An example fuel economy calculation appears in appendix II to this part. (a) Calculate the FTP fuel economy as follows: (1) Calculate the weighted grams/mile values for the FTP test for CO 2 , HC, and CO, and where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 as specified in 40 CFR 1066.605. Measure and record the test fuel's properties as specified in paragraph (f) of this section. (2) Calculate separately the grams/mile values for the cold transient phase, stabilized phase and hot transient phase of the FTP test. For vehicles with more than one source of propulsion energy, one of which is a rechargeable energy storage system, or vehicles with special features that the Administrator determines may have a rechargeable energy source, whose charge can vary during the test, calculate separately the grams/mile values for the cold transient phase, stabilized phase, hot transient phase and hot stabilized phase of the FTP test. (b) Calculate the HFET fuel economy as follows: (1) Calculate the mass values for the highway fuel economy test for HC, CO, and CO 2 , and where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 as specified in 40 CFR 1066.605. Measure and record the test fuel's properties as specified in paragraph (f) of this section. (2) Calculate the grams/mile values for the highway fuel economy test for HC, CO, and CO 2 , and where applicable CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 by dividing the mass values obtained in paragraph (b)(1) of this section, by the actual driving distance, measured in miles, as specified in 40 CFR 1066.840. (c) Calculate the cold temperature FTP fuel economy as follows: (1) Calculate the weighted grams/mile values for the cold temperature FTP test for HC, CO, and CO 2 , and where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 as specified in 40 CFR 1066.605. (2) Calculate separately the grams/mile values for the cold transient phase, stabilized phase and hot transient phase of the cold temperature FTP test as specified in 40 CFR 1066.605. (3) Measure and record the test fuel's properties as specified in paragraph (f) of this section. (d) Calculate the US06 fuel economy as follows: (1) Calculate the total grams/mile values for the US06 test for HC, CO, and CO 2 , and where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 as specified in 40 CFR 1066.605. (2) Calculate separately the grams/mile values for HC, CO, and CO 2 , and where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 , for both the US06 City phase and the US06 Highway phase of the US06 test as specified in 40 CFR 1066.605 and 1066.831. In lieu of directly measuring the emissions of the separate city and highway phases of the US06 test according to the provisions of 40 CFR 1066.831, the manufacturer may optionally, with the advance approval of the Administrator and using good engineering judgment, analytically determine the grams/mile values for the city and highway phases of the US06 test. To analytically determine US06 City and US06 Highway phase emission results, the manufacturer shall multiply the US06 total grams/mile values determined in paragraph (d)(1) of this section by the estimated proportion of fuel use for the city and highway phases relative to the total US06 fuel use. The manufacturer may estimate the proportion of fuel use for the US06 City and US06 Highway phases by using modal CO 2 , HC, and CO emissions data, or by using appropriate OBD data ( e.g., fuel flow rate in grams of fuel per second), or another method approved by the Administrator. (3) Measure and record the test fuel's properties as specified in paragraph (f) of this section. (e) Calculate the SC03 fuel economy as follows: (1) Calculate the grams/mile values for the SC03 test for HC, CO, and CO 2 , and where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 as specified in 40 CFR 1066.605. (2) Measure and record the test fuel's properties as specified in paragraph (f) of this section. (f) Analyze and determine fuel properties as follows: (1) Gasoline test fuel properties shall be determined by analysis of a fuel sample taken from the fuel supply. A sample shall be taken after each addition of fresh fuel to the fuel supply. Additionally, the fuel shall be resampled once a month to account for any fuel property changes during storage. Less frequent resampling may be permitted if EPA concludes, on the basis of manufacturer-supplied data, that the properties of test fuel in the manufacturer's storage facility will remain stable for a period longer than one month. The fuel samples shall be analyzed to determine fuel properties as follows for neat gasoline (E0) and for a low-level ethanol-gasoline blend (E10): (i) Specific gravity. Determine specific gravity using ASTM D4052 (incorporated by reference, see § 600.011). Note that ASTM D4052 refers to specific gravity as relative density. (ii) Carbon mass fraction. (A) For E0, determine hydrogen mass percent using ASTM D3343 (incorporated by reference, see § 600.011), then determine carbon mass fraction as CMF = 1−0.01 × hydrogen mass percent. (B) For E10, determine carbon mass fraction of test fuel, CMF f , using the following equation, rounded to three decimal places: Where: VF e = volume fraction of ethanol in the test fuel as determined from ASTM D4815 or ASTM D5599 (both incorporated by reference, see § 600.011). Calculate the volume fraction by dividing the volume percent of ethanol by 100. SG e = specific gravity of pure ethanol. Use SG e = 0.7939. SG f = specific gravity of the test fuel as determined by ASTM D1298 or ASTM D4052 (both incorporated by reference, see § 600.011). CMF e = carbon mass fraction of pure ethanol. Use CMF e = 0.5214. CMF h = carbon mass fraction of the hydrocarbon fraction of the test fuel as determined using ASTM D3343 (incorporated by reference, see § 600.011) with the following inputs, using V Tier3 or V LEVIII as appropriate: Where: VF e = volume fraction of ethanol in the test fuel as determined from ASTM D4815 or ASTM D5599 (both incorporated by reference, see § 600.011). Calculate the volume fraction by dividing the volume percent of ethanol by 100. SG e = specific gravity of pure ethanol. Use SG e = 0.7939. SG f = specific gravity of the test fuel as determined by ASTM D1298 or ASTM D4052 (both incorporated by reference, see § 600.011). CMF e = carbon mass fraction of pure ethanol. Use CMF e = 0.5214. CMF h = carbon mass fraction of the hydrocarbon fraction of the test fuel as determined using ASTM D3343 (incorporated by reference, see § 600.011) with the following inputs, using V Tier3 or V LEVIII as appropriate: Where: VP aro,f = volume percent aromatics in the test fuel as determined by ASTM D1319 (incorporated by reference, see § 600.011). An acceptable alternative method is ASTM D5769 (incorporated by reference, see § 600.011), as long as the result is bias-corrected as described in ASTM D1319. Where: VP aro,f = volume percent aromatics in the test fuel as determined by ASTM D1319 (incorporated by reference, see § 600.011). An acceptable alternative method is ASTM D5769 (incorporated by reference, see § 600.011), as long as the result is bias-corrected as described in ASTM D1319. T 10 , T 50 , T 90 = the 10, 50, and 90 percent distillation temperatures of the test fuel, respectively, in degrees Fahrenheit, as determined by ASTM D86 (incorporated by reference, see § 600.011). (iii) Net heat of combustion. (A) For E0, determine net heat of combustion in MJ/kg using ASTM D3338/D3338M (incorporated by reference, see § 600.011). (B) For E10, determine net heat of combustion, NHC f , in MJ/kg using the following equation, rounding the result to the nearest whole number: Where: NHC e = net heat of combustion of pure ethanol. Use NHC e = 11,530 Btu/lb. NHC h = net heat of combustion of the hydrocarbon fraction of the test fuel as determined using ASTM D3338 (incorporated by reference, see § 600.011) using input values as specified in paragraph (f)(1)(ii) of this section. Where: NHC e = net heat of combustion of pure ethanol. Use NHC e = 11,530 Btu/lb. NHC h = net heat of combustion of the hydrocarbon fraction of the test fuel as determined using ASTM D3338 (incorporated by reference, see § 600.011) using input values as specified in paragraph (f)(1)(ii) of this section. (2) Methanol test fuel shall be analyzed to determine the following fuel properties: (i) Specific gravity using ASTM D 1298 (incorporated by reference in § 600.011). You may determine specific gravity for the blend, or you may determine specific gravity for the gasoline and methanol fuel components separately before combining the results using the following equation: SG = SGg × volume fraction gasoline + SGm × volume fraction methanol. (ii)(A) Carbon weight fraction using the following equation: CWF = CWFg × MFg + 0.375 × MFm Where: CWFg = Carbon weight fraction of gasoline portion of blend measured using ASTM D 3343 (incorporated by reference in § 600.011). MFg = Mass fraction gasoline = (G × SGg)/(G × SGg + M × SGm) MFm = Mass fraction methanol = (M × SGm)/(G × SGg + M × SGm) Where: CWFg = Carbon weight fraction of gasoline portion of blend measured using ASTM D 3343 (incorporated by reference in § 600.011). MFg = Mass fraction gasoline = (G × SGg)/(G × SGg + M × SGm) MFm = Mass fraction methanol = (M × SGm)/(G × SGg + M × SGm) Where: G = Volume fraction gasoline. M = Volume fraction methanol. SGg = Specific gravity of gasoline as measured using ASTM D 1298 (incorporated by reference in § 600.011). SGm = Specific gravity of methanol as measured using ASTM D 1298 (incorporated by reference in § 600.011). Where: G = Volume fraction gasoline. M = Volume fraction methanol. SGg = Specific gravity of gasoline as measured using ASTM D 1298 (incorporated by reference in § 600.011). SGm = Specific gravity of methanol as measured using ASTM D 1298 (incorporated by reference in § 600.011). (B) Upon the approval of the Administrator, other procedures to measure the carbon weight fraction of the fuel blend may be used if the manufacturer can show that the procedures are superior to or equally as accurate as those specified in this paragraph (f)(2)(ii). (3) Natural gas test fuel shall be analyzed to determine the following fuel properties: (i) Fuel composition measured using ASTM D 1945 (incorporated by reference in § 600.011). (ii) Specific gravity measured as based on fuel composition per ASTM D 1945 (incorporated by reference in § 600.011). (iii) Carbon weight fraction, based on the carbon contained only in the hydrocarbon constituents of the fuel. This equals the weight of carbon in the hydrocarbon constituents divided by the total weight of fuel. (iv) Carbon weight fraction of the fuel, which equals the total weight of carbon in the fuel ( i.e., includes carbon contained in hydrocarbons and in CO 2 ) divided by the total weight of fuel. (4) Ethanol test fuel shall be analyzed to determine the following fuel properties: (i) Specific gravity using ASTM D 1298 (incorporated by reference in § 600.011). You may determine specific gravity for the blend, or you may determine specific gravity for the gasoline and methanol fuel components separately before combining the results using the following equation: SG = SGg × volume fraction gasoline + SGe × volume fraction ethanol. (ii)(A) Carbon weight fraction using the following equation: CWF = CWFg × MFg + 0.521 × MFe Where: CWFg = Carbon weight fraction of gasoline portion of blend measured using ASTM D 3343 (incorporated by reference in § 600.011). MFg = Mass fraction gasoline = (G × SGg)/(G × SGg + E × SGe) MFe = Mass fraction ethanol = (E × SGe)/(G × SGg + E × SGe) Where: CWFg = Carbon weight fraction of gasoline portion of blend measured using ASTM D 3343 (incorporated by reference in § 600.011). MFg = Mass fraction gasoline = (G × SGg)/(G × SGg + E × SGe) MFe = Mass fraction ethanol = (E × SGe)/(G × SGg + E × SGe) Where: G = Volume fraction gasoline. E = Volume fraction ethanol. SGg = Specific gravity of gasoline as measured using ASTM D 1298 (incorporated by reference in § 600.011). SGe = Specific gravity of ethanol as measured using ASTM D 1298 (incorporated by reference in § 600.011). Where: G = Volume fraction gasoline. E = Volume fraction ethanol. SGg = Specific gravity of gasoline as measured using ASTM D 1298 (incorporated by reference in § 600.011). SGe = Specific gravity of ethanol as measured using ASTM D 1298 (incorporated by reference in § 600.011). (B) Upon the approval of the Administrator, other procedures to measure the carbon weight fraction of the fuel blend may be used if the manufacturer can show that the procedures are superior to or equally as accurate as those specified in this paragraph (f)(4)(ii). (g) Calculate separate FTP, highway, US06, SC03 and Cold temperature FTP fuel economy and carbon-related exhaust emissions from the grams/mile values for total HC, CO, CO 2 and, where applicable, CH 3 OH, C 2 H 5 OH, C 2 H 4 O, HCHO, NMHC, N 2 O, and CH 4 , and the test fuel's specific gravity, carbon weight fraction, net heating value, and additionally for natural gas, the test fuel's composition. (1) Emission values for fuel economy calculations. The emission values (obtained per paragraph (a) through (e) of this section, as applicable) used in the calculations of fuel economy in this section shall be rounded in accordance with § 86.1837 of this chapter. The CO 2 values (obtained per this section, as applicable) used in each calculation of fuel economy in this section shall be rounded to the nearest gram/mile. (2) Emission values for carbon-related exhaust emission calculations. (i) If the emission values (obtained per paragraph (a) through (e) of this section, as applicable) were obtained from testing with aged exhaust emission control components as allowed under § 86.1823 of this chapter, then these test values shall be used in the calculations of carbon-related exhaust emissions in this section. (ii) If the emission values (obtained per paragraph (a) through (e) of this section, as applicable) were not obtained from testing with aged exhaust emission control components as allowed under § 86.1823 of this chapter, then these test values shall be adjusted by the appropriate deterioration factor determined according to § 86.1823 of this chapter before being used in the calculations of carbon-related exhaust emissions in this section. For vehicles within a test group, the appropriate NMOG deterioration factor may be used in lieu of the deterioration factors for CH 3 OH, C 2 H 5 OH, and/or C 2 H 4 O emissions. (iii) The emission values determined in paragraph (g)(2)(i) or (ii) of this section shall be rounded in accordance with § 86.1837 of this chapter. The CO 2 values (obtained per this section, as applicable) used in each calculation of carbon-related exhaust emissions in this section shall be rounded to the nearest gram/mile. (iv) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, N 2 O and CH 4 emission values for use in the calculation of carbon-related exhaust emissions in this section shall be the values determined according to paragraph (g)(2)(iv)(A), (B), or (C) of this section. (A) The FTP and HFET test values as determined for the emission data vehicle according to the provisions of § 86.1835 of this chapter. These values shall apply to all vehicles tested under this section that are included in the test group represented by the emission data vehicle and shall be adjusted by the appropriate deterioration factor determined according to § 86.1823 of this chapter before being used in the calculations of carbon-related exhaust emissions in this section, except that in-use test data shall not be adjusted by a deterioration factor. (B) The FTP and HFET test values as determined according to testing conducted under the provisions of this subpart. These values shall be adjusted by the appropriate deterioration factor determined according to § 86.1823 of this chapter before being used in the calculations of carbon-related exhaust emissions in this section, except that in-use test data shall not be adjusted by a deterioration factor. (C) For the 2012 through 2016 model years only, manufacturers may use an assigned value of 0.010 g/mi for N 2 O FTP and HFET test values. This value is not required to be adjusted by a deterioration factor. (3) The specific gravity and the carbon weight fraction (obtained per paragraph (f) of this section) shall be recorded using three places to the right of the decimal point. The net heating value (obtained per paragraph (f) of this section) shall be recorded to the nearest whole Btu/lb. (4) For the purpose of determining the applicable in-use CO 2 exhaust emission standard under § 86.1818 of this chapter, the combined city/highway carbon-related exhaust emission value for a vehicle subconfiguration is calculated by arithmetically averaging the FTP-based city and HFET-based highway carbon-related exhaust emission values, as determined in paragraphs (h) through (n) of this section for the subconfiguration, weighted 0.55 and 0.45 respectively, and rounded to the nearest tenth of a gram per mile. (h)(1) For gasoline-fueled automobiles tested on a test fuel specified in § 86.113 of this chapter, the fuel economy in miles per gallon is to be calculated using the following equation and rounded to the nearest 0.1 miles per gallon: mpg = (5174 × 10 4 × CWF × SG)/[((CWF × HC) + (0.429 × CO) + (0.273 × CO 2 )) × ((0.6 × SG × NHV) + 5471)] Where: HC = Grams/mile HC as obtained in paragraph (g)(1) of this section. CO = Grams/mile CO as obtained in paragraph (g)(1) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(1) of this section. CWF = Carbon weight fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. NHV = Net heating value by mass of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. SG = Specific gravity of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. Where: HC = Grams/mile HC as obtained in paragraph (g)(1) of this section. CO = Grams/mile CO as obtained in paragraph (g)(1) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(1) of this section. CWF = Carbon weight fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. NHV = Net heating value by mass of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. SG = Specific gravity of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. (2)(i) For 2012 and later model year gasoline-fueled automobiles tested on a test fuel specified in § 86.113 of this chapter, the carbon-related exhaust emissions in grams per mile is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = (CWF/0.273 × HC) + (1.571 × CO) + CO 2 Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CWF = Carbon weight fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CWF = Carbon weight fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, the carbon-related exhaust emissions in grams per mile for 2012 and later model year gasoline-fueled automobiles tested on a test fuel specified in § 86.113 of this chapter is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = [(CWF/0.273) × NMHC] + (1.571 × CO) + CO 2 + (298 × N 2 O) + (25 × CH 4 ) Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. CWF = Carbon weight fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. CWF = Carbon weight fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. (i)(1) For diesel-fueled automobiles, calculate the fuel economy in miles per gallon of diesel fuel by dividing 2778 by the sum of three terms and rounding the quotient to the nearest 0.1 mile per gallon: (i)(A) 0.866 multiplied by HC (in grams/miles as obtained in paragraph (g)(1) of this section), or (B) Zero, in the case of cold FTP diesel tests for which HC was not collected, as permitted in § 600.113-08(c); (ii) 0.429 multiplied by CO (in grams/mile as obtained in paragraph (g)(1) of this section); and (iii) 0.273 multiplied by CO 2 (in grams/mile as obtained in paragraph (g)(1) of this section). (2)(i) For 2012 and later model year diesel-fueled automobiles, the carbon-related exhaust emissions in grams per mile is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = (3.172 × HC) + (1.571 × CO) + CO 2 Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, the carbon-related exhaust emissions in grams per mile for 2012 and later model year diesel-fueled automobiles is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = (3.172 × NMHC) + (1.571 × CO) + CO 2 + (298 × N 2 O) + (25 × CH 4 ) Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emissions as defined in § 600.002. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. (j)(1) For methanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and methanol, the fuel economy in miles per gallon of methanol is to be calculated using the following equation: mpg = (CWF × SG × 3781.8)/((CWF exHC × HC) + (0.429 × CO) + (0.273 × CO 2 ) + (0.375 × CH 3 OH) + (0.400 × HCHO)) Where: CWF = Carbon weight fraction of the fuel as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section. SG = Specific gravity of the fuel as determined in paragraph (f)(2)(i) of this section and rounded according to paragraph (g)(3) of this section. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section (for M100 fuel, CWF exHC = 0.866). HC = Grams/mile HC as obtained in paragraph (g)(1) of this section. CO = Grams/mile CO as obtained in paragraph (g)(1) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(1) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(1) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(1) of this section. Where: CWF = Carbon weight fraction of the fuel as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section. SG = Specific gravity of the fuel as determined in paragraph (f)(2)(i) of this section and rounded according to paragraph (g)(3) of this section. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section (for M100 fuel, CWF exHC = 0.866). HC = Grams/mile HC as obtained in paragraph (g)(1) of this section. CO = Grams/mile CO as obtained in paragraph (g)(1) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(1) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(1) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(1) of this section. (2)(i) For 2012 and later model year methanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and methanol, the carbon-related exhaust emissions in grams per mile while operating on methanol is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = (CWF exHC /0.273 × HC) + (1.571 × CO) + (1.374 × CH 3 OH) + (1.466 × HCHO) + CO 2 Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section (for M100 fuel, CWF exHC = 0.866). HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section (for M100 fuel, CWF exHC = 0.866). HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, the carbon-related exhaust emissions in grams per mile for 2012 and later model year methanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and methanol while operating on methanol is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = [(CWF exHC /0.273) × NMHC] + (1.571 × CO) + (1.374 × CH 3 OH) + (1.466 × HCHO) + CO 2 + (298 × N 2 O) + (25 × CH 4 ) Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section (for M100 fuel, CWF exHC = 0.866). NMHC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(2)(ii) of this section and rounded according to paragraph (g)(3) of this section (for M100 fuel, CWF exHC = 0.866). NMHC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. (k)(1) For automobiles fueled with natural gas and automobiles designed to operate on gasoline and natural gas, the fuel economy in miles per gallon of natural gas is to be calculated using the following equation: Where: mpg e = miles per gasoline gallon equivalent of natural gas. CWF HC/NG = carbon weight fraction based on the hydrocarbon constituents in the natural gas fuel as obtained in paragraph (f)(3) of this section and rounded according to paragraph (g)(3) of this section. D NG = density of the natural gas fuel [grams/ft 3 at 68 °F (20 °C) and 760 mm Hg (101.3 kPa)] pressure as obtained in paragraph (g)(3) of this section. CH 4 , NMHC, CO, and CO 2 = weighted mass exhaust emissions [grams/mile] for methane, non-methane HC, carbon monoxide, and carbon dioxide as obtained in paragraph (g)(2) of this section. CWF NMHC = carbon weight fraction of the non-methane HC constituents in the fuel as determined from the speciated fuel composition per paragraph (f)(3) of this section and rounded according to paragraph (g)(3) of this section. CO 2NG = grams of carbon dioxide in the natural gas fuel consumed per mile of travel. CO 2NG = FC NG × D NG × WF CO2 Where: = cubic feet of natural gas fuel consumed per mile Where: mpg e = miles per gasoline gallon equivalent of natural gas. CWF HC/NG = carbon weight fraction based on the hydrocarbon constituents in the natural gas fuel as obtained in paragraph (f)(3) of this section and rounded according to paragraph (g)(3) of this section. D NG = density of the natural gas fuel [grams/ft 3 at 68 °F (20 °C) and 760 mm Hg (101.3 kPa)] pressure as obtained in paragraph (g)(3) of this section. CH 4 , NMHC, CO, and CO 2 = weighted mass exhaust emissions [grams/mile] for methane, non-methane HC, carbon monoxide, and carbon dioxide as obtained in paragraph (g)(2) of this section. CWF NMHC = carbon weight fraction of the non-methane HC constituents in the fuel as determined from the speciated fuel composition per paragraph (f)(3) of this section and rounded according to paragraph (g)(3) of this section. CO 2NG = grams of carbon dioxide in the natural gas fuel consumed per mile of travel. CO 2NG = FC NG × D NG × WF CO2 Where: = cubic feet of natural gas fuel consumed per mile Where: CWF NG = the carbon weight fraction of the natural gas fuel as calculated in paragraph (f)(3) of this section. WF CO2 = weight fraction carbon dioxide of the natural gas fuel calculated using the mole fractions and molecular weights of the natural gas fuel constituents per ASTM D 1945 (incorporated by reference in § 600.011). Where: CWF NG = the carbon weight fraction of the natural gas fuel as calculated in paragraph (f)(3) of this section. WF CO2 = weight fraction carbon dioxide of the natural gas fuel calculated using the mole fractions and molecular weights of the natural gas fuel constituents per ASTM D 1945 (incorporated by reference in § 600.011). (2)(i) For automobiles fueled with natural gas and automobiles designed to operate on gasoline and natural gas, the carbon-related exhaust emissions in grams per mile while operating on natural gas is to be calculated for 2012 and later model year vehicles using the following equation and rounded to the nearest 1 gram per mile: CREE = 2.743 × CH 4 + CWF NMHC /0.273 × NMHC + 1.571 × CO + CO 2 Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CWF NMHC = carbon weight fraction of the non-methane HC constituents in the fuel as determined from the speciated fuel composition per paragraph (f)(3) of this section and rounded according to paragraph (f)(3) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CWF NMHC = carbon weight fraction of the non-methane HC constituents in the fuel as determined from the speciated fuel composition per paragraph (f)(3) of this section and rounded according to paragraph (f)(3) of this section. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, the carbon-related exhaust emissions in grams per mile for 2012 and later model year automobiles fueled with natural gas and automobiles designed to operate on gasoline and natural gas while operating on natural gas is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = (25 × CH 4 ) + [(CWF NMHC /0.273) × NMHC] + (1.571 × CO) + CO 2 + (298 × N 2 O) Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CWF NMHC = carbon weight fraction of the non-methane HC constituents in the fuel as determined from the speciated fuel composition per paragraph (f)(3) of this section and rounded according to paragraph (f)(3) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. NMHC = Grams/mile NMHC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CWF NMHC = carbon weight fraction of the non-methane HC constituents in the fuel as determined from the speciated fuel composition per paragraph (f)(3) of this section and rounded according to paragraph (f)(3) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. (l)(1) For ethanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and ethanol, the fuel economy in miles per gallon of ethanol is to be calculated using the following equation: mpg = (CWF × SG × 3781.8)/((CWF exHC × HC) + (0.429 × CO) + (0.273 × CO 2 ) + (0.375 × CH 3 OH) + (0.400 × HCHO) + (0.521 × C 2 H 5 OH) + (0.545 × C 2 H 4 O)) Where: CWF = Carbon weight fraction of the fuel as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. SG = Specific gravity of the fuel as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(1) of this section. CO = Grams/mile CO as obtained in paragraph (g)(1) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(1) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(1) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(1) of this section. C 2 H 5 OH = Grams/mile C 2 H 5 OH (ethanol) as obtained in paragraph (g)(1) of this section. C 2 H 4 O = Grams/mile C 2 H 4 O (acetaldehyde) as obtained in paragraph (g)(1) of this section. Where: CWF = Carbon weight fraction of the fuel as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. SG = Specific gravity of the fuel as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(1) of this section. CO = Grams/mile CO as obtained in paragraph (g)(1) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(1) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(1) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(1) of this section. C 2 H 5 OH = Grams/mile C 2 H 5 OH (ethanol) as obtained in paragraph (g)(1) of this section. C 2 H 4 O = Grams/mile C 2 H 4 O (acetaldehyde) as obtained in paragraph (g)(1) of this section. (2)(i) For 2012 and later model year ethanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and ethanol, the carbon-related exhaust emissions in grams per mile while operating on ethanol is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = (CWF exHC /0.273 × HC) + (1.571 × CO) + (1.374 × CH 3 OH) + (1.466 × HCHO) + (1.911 × C 2 H 5 OH) + (1.998 × C 2 H 4 O) + CO 2 Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. C 2 H 5 OH = Grams/mile C 2 H 5 OH (ethanol) as obtained in paragraph (g)(2) of this section. C 2 H 4 O = Grams/mile C 2 H 4 O (acetaldehyde) as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. C 2 H 5 OH = Grams/mile C 2 H 5 OH (ethanol) as obtained in paragraph (g)(2) of this section. C 2 H 4 O = Grams/mile C 2 H 4 O (acetaldehyde) as obtained in paragraph (g)(2) of this section. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, the carbon-related exhaust emissions in grams per mile for 2012 and later model year ethanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and ethanol while operating on ethanol is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = [(CWF exHC /0.273) × NMHC] + (1.571 × CO) + (1.374 × CH 3 OH) + (1.466 × HCHO) + (1.911 × C 2 H 5 OH) + (1.998 × C 2 H 4 O) + CO 2 + (298 × N 2 O) + (25 × CH 4 ) Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. NMHC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. C 2 H 5 OH = Grams/mile C 2 H 5 OH (ethanol) as obtained in paragraph (g)(2) of this section. C 2 H 4 O = Grams/mile C 2 H 4 O (acetaldehyde) as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF exHC = Carbon weight fraction of exhaust hydrocarbons = CWF as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. NMHC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. CH 3 OH = Grams/mile CH 3 OH (methanol) as obtained in paragraph (g)(2) of this section. HCHO = Grams/mile HCHO (formaldehyde) as obtained in paragraph (g)(2) of this section. C 2 H 5 OH = Grams/mile C 2 H 5 OH (ethanol) as obtained in paragraph (g)(2) of this section. C 2 H 4 O = Grams/mile C 2 H 4 O (acetaldehyde) as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. (m)(1) For automobiles fueled with liquefied petroleum gas and automobiles designed to operate on gasoline and liquefied petroleum gas, the fuel economy in miles per gallon of liquefied petroleum gas is to be calculated using the following equation: Where: mpg e = miles per gasoline gallon equivalent of liquefied petroleum gas. CWF fuel = carbon weight fraction based on the hydrocarbon constituents in the liquefied petroleum gas fuel as obtained in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. SG = Specific gravity of the fuel as determined in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. 3781.8 = Grams of H 2 O per gallon conversion factor. CWF HC = Carbon weight fraction of exhaust hydrocarbon = CWF fuel as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. Where: mpg e = miles per gasoline gallon equivalent of liquefied petroleum gas. CWF fuel = carbon weight fraction based on the hydrocarbon constituents in the liquefied petroleum gas fuel as obtained in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. SG = Specific gravity of the fuel as determined in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. 3781.8 = Grams of H 2 O per gallon conversion factor. CWF HC = Carbon weight fraction of exhaust hydrocarbon = CWF fuel as determined in paragraph (f)(4) of this section and rounded according to paragraph (f)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. (2)(i) For automobiles fueled with liquefied petroleum gas and automobiles designed to operate on gasoline and liquefied petroleum gas, the carbon-related exhaust emissions in grams per mile while operating on liquefied petroleum gas is to be calculated for 2012 and later model year vehicles using the following equation and rounded to the nearest 1 gram per mile: CREE = (CWF HC /0.273 × HC) + (1.571 × CO) + CO 2 Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF HC = Carbon weight fraction of exhaust hydrocarbon = CWF fuel as determined in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF HC = Carbon weight fraction of exhaust hydrocarbon = CWF fuel as determined in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. HC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter, the carbon-related exhaust emissions in grams per mile for 2012 and later model year automobiles fueled with liquefied petroleum gas and automobiles designed to operate on mixtures of gasoline and liquefied petroleum gas while operating on liquefied petroleum gas is to be calculated using the following equation and rounded to the nearest 1 gram per mile: CREE = [(CWF exHC /0.273) × NMHC] + (1.571 × CO) + CO 2 + (298 × N 2 O) + (25 × CH 4 ) Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF HC = Carbon weight fraction of exhaust hydrocarbon = CWF fuel as determined in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. NMHC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. Where: CREE means the carbon-related exhaust emission value as defined in § 600.002. CWF HC = Carbon weight fraction of exhaust hydrocarbon = CWF fuel as determined in paragraph (f)(5) of this section and rounded according to paragraph (g)(3) of this section. NMHC = Grams/mile HC as obtained in paragraph (g)(2) of this section. CO = Grams/mile CO as obtained in paragraph (g)(2) of this section. CO 2 = Grams/mile CO 2 as obtained in paragraph (g)(2) of this section. N 2 O = Grams/mile N 2 O as obtained in paragraph (g)(2) of this section. CH 4 = Grams/mile CH 4 as obtained in paragraph (g)(2) of this section. (n) Manufacturers may use a value of 0 grams CO 2 and CREE per mile to represent the emissions of electric vehicles and the electric operation of plug-in hybrid electric vehicles derived from electricity generated from sources that are not onboard the vehicle. (o)(1) For testing with E10, calculate fuel economy using the following equation, rounded to the nearest 0.1 miles per gallon: Where: CMF testfuel = carbon mass fraction of the test fuel, expressed to three decimal places. SG testfuel = the specific gravity of the test fuel as obtained in paragraph (f)(1) of this section, expressed to three decimal places. r H2O = the density of pure water at 60 °F. Use r H2O = 3781.69 g/gal. SG basefuel = the specific gravity of the 1975 base fuel. Use SG basefuel = 0.7394. NHC basefuel = net heat of combustion of the 1975 base fuel. Use NHC basefuel = 43.047 MJ/kg. NMOG = NMOG emission rate over the test interval or duty cycle in grams/mile. CH 4 = CH 4 emission rate over the test interval or duty cycle in grams/mile. CO = CO emission rate over the test interval or duty cycle in grams/mile. CO 2 = measured tailpipe CO 2 emission rate over the test interval or duty cycle in grams/mile. R a = sensitivity factor that represents the response of a typical vehicle's fuel economy to changes in fuel properties, such as volumetric energy content. Use R a = 0.81. NHC testfuel = net heat of combustion by mass of test fuel as obtained in paragraph (f)(1) of this section, expressed to three decimal places. Where: CMF testfuel = carbon mass fraction of the test fuel, expressed to three decimal places. SG testfuel = the specific gravity of the test fuel as obtained in paragraph (f)(1) of this section, expressed to three decimal places. r H2O = the density of pure water at 60 °F. Use r H2O = 3781.69 g/gal. SG basefuel = the specific gravity of the 1975 base fuel. Use SG basefuel = 0.7394. NHC basefuel = net heat of combustion of the 1975 base fuel. Use NHC basefuel = 43.047 MJ/kg. NMOG = NMOG emission rate over the test interval or duty cycle in grams/mile. CH 4 = CH 4 emission rate over the test interval or duty cycle in grams/mile. CO = CO emission rate over the test interval or duty cycle in grams/mile. CO 2 = measured tailpipe CO 2 emission rate over the test interval or duty cycle in grams/mile. R a = sensitivity factor that represents the response of a typical vehicle's fuel economy to changes in fuel properties, such as volumetric energy content. Use R a = 0.81. NHC testfuel = net heat of combustion by mass of test fuel as obtained in paragraph (f)(1) of this section, expressed to three decimal places. (2) Use one of the following methods to calculate the carbon-related exhaust emissions for testing model year 2027 and later vehicles with the E10 test fuel specified in 40 CFR 1065.710(b): (i) For manufacturers not complying with the fleet averaging option for N 2 O and CH 4 as allowed under 40 CFR 86.1818-12(f)(2), calculate CREE using the following equation, rounded to the nearest whole gram per mile: CREE = ( CMF /0.273 · NMOG ) + (1.571 · CO ) + CO 2 + (0.749 · CH 4 ) Where: CREE = carbon-related exhaust emissions. CMF = carbon mass fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. NMOG = NMOG emission rate obtained in 40 CFR 1066.635 in grams/mile. CO = CO emission rate obtained in paragraph (g)(2) of this section in grams/mile. CO 2 = measured tailpipe CO 2 emission rate obtained in paragraph (g)(2) of this section in grams/mile. CH 4 = CH 4 emission rate obtained in paragraph (g)(2) of this section in grams/mile. Where: CREE = carbon-related exhaust emissions. CMF = carbon mass fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. NMOG = NMOG emission rate obtained in 40 CFR 1066.635 in grams/mile. CO = CO emission rate obtained in paragraph (g)(2) of this section in grams/mile. CO 2 = measured tailpipe CO 2 emission rate obtained in paragraph (g)(2) of this section in grams/mile. CH 4 = CH 4 emission rate obtained in paragraph (g)(2) of this section in grams/mile. (ii) For manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under 40 CFR 86.1818-12(f)(2), calculate CREE using the following equation, rounded to the nearest whole gram per mile: CREE = [( CMF /0.273) · NMOG ] + (1.571 · CO ) + CO 2 + (298 · N 2 O ) + (25 · CH 4 ) Where: CREE = the carbon-related exhaust emissions as defined in § 600.002. NMOG = NMOG emission rate obtained in 40 CFR 1066.635 in grams/mile. CO = CO emission rate obtained in paragraph (g)(2) of this section in grams/mile. CO 2 = measured tailpipe CO 2 emission rate obtained in paragraph (g)(2) of this section in grams/mile. N 2 O = N 2 O emission rate obtained in paragraph (g)(2) of this section in grams/mile. CH 4 = CH 4 emission rate obtained in paragraph (g)(2) of this section in grams/mile. CMF = carbon mass fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. Where: CREE = the carbon-related exhaust emissions as defined in § 600.002. NMOG = NMOG emission rate obtained in 40 CFR 1066.635 in grams/mile. CO = CO emission rate obtained in paragraph (g)(2) of this section in grams/mile. CO 2 = measured tailpipe CO 2 emission rate obtained in paragraph (g)(2) of this section in grams/mile. N 2 O = N 2 O emission rate obtained in paragraph (g)(2) of this section in grams/mile. CH 4 = CH 4 emission rate obtained in paragraph (g)(2) of this section in grams/mile. CMF = carbon mass fraction of test fuel as obtained in paragraph (f)(1) of this section and rounded according to paragraph (g)(3) of this section. (p) Equations for fuels other than those specified in this section may be used with advance EPA approval. Alternate calculation methods for fuel economy and carbon-related exhaust emissions may be used in lieu of the methods described in this section if shown to yield equivalent or superior results and if approved in advance by the Administrator." 40:40:32.0.1.4.44.2.13.5,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.114-12 Vehicle-specific 5-cycle fuel economy and carbon-related exhaust emission calculations.,EPA,,,"[76 FR 39538, July 6, 2011, as amended at 76 FR 57379, Sept. 15, 2011; 89 FR 28204, Apr. 18, 2024]","Paragraphs (a) through (f) of this section apply to data used for fuel economy labeling under subpart D of this part. Paragraphs (d) through (f) of this section are used to calculate 5-cycle carbon-related exhaust emission values for the purpose of determining optional credits for CO 2 -reducing technologies under § 86.1866 of this chapter and to calculate 5-cycle CO 2 values for the purpose of fuel economy labeling under subpart D of this part. (a) City fuel economy. For each vehicle tested under § 600.010-08(a), (b), or (c), as applicable, determine the 5-cycle city fuel economy using the following equation: (2) Terms used in the equations in this paragraph (a) are defined as follows: Bag Y FE X = the fuel economy in miles per gallon of fuel during bag Y of the FTP test conducted at an ambient temperature X of 75 °F or 20 °F. SC03 FE = fuel economy in mile per gallon over the SC03 test. US06 City FE = fuel economy in miles per gallon over the “city” portion of the US06 test. (b) Highway fuel economy. (1) For each vehicle tested under § 600.010-08(a), (b), or (c), as applicable, determine the 5-cycle highway fuel economy using the following equation: (2) If the condition specified in § 600.115-08(b)(2)(iii)(B) is met, in lieu of using the calculation in paragraph (b)(1) of this section, the manufacturer may optionally determine the highway fuel economy using the following modified 5-cycle equation which utilizes data from FTP, HFET, and US06 tests, and applies mathematic adjustments for Cold FTP and SC03 conditions: (i) Perform a US06 test in addition to the FTP and HFET tests. (ii) Determine the 5-cycle highway fuel economy according to the following formula: (3) Terms used in the equations in this paragraph (b) are defined as follows: Bag Y FE X = the fuel economy in miles per gallon of fuel during bag Y of the FTP test conducted at an ambient temperature X of 75 °F or 20 °F. HFET FE = fuel economy in miles per gallon over the HFET test. SC03 FE = fuel economy in mile per gallon over the SC03 test. US06 Highway FE = fuel economy in miles per gallon over the highway portion of the US06 test. US06 FE = fuel economy in miles per gallon over US06 test. (c) Fuel economy calculations for hybrid electric vehicles. Test hybrid electric vehicles as described in SAE J1711 (incorporated by reference in § 600.011). For FTP testing, this generally involves emission sampling over four phases (bags) of the UDDS (cold-start, transient, warm-start, transient); however, these four phases may be combined into two phases (phases 1 + 2 and phases 3 + 4). Calculations for these sampling methods follow: (1) Four-bag FTP equations. If the 4-bag sampling method is used, manufacturers may use the equations in paragraphs (a) and (b) of this section to determine city and highway fuel economy estimates. If this method is chosen, it must be used to determine both city and highway fuel economy. Optionally, the following calculations may be used, provided that they are used to determine both city and highway fuel economy: (i) City fuel economy. (ii) Highway fuel economy. (2) Two-bag FTP equations. If the 2-bag sampling method is used for the 75 °F FTP test, it must be used to determine both city and highway fuel economy. The following calculations must be used to determine both city and highway fuel economy: (i) City fuel economy. (ii) Highway fuel economy. (3) For hybrid electric vehicles using the modified 5-cycle highway calculation in paragraph (b)(2) of this section, the equation in paragraph (b)(2)(ii)(A) of this section applies except that the equation for Start Fuel 75 will be replaced with one of the following: (i) The equation for Start Fuel 75 for hybrids tested according to the 4-bag FTP is: (ii) The equation for Start Fuel 75 for hybrids tested according to the 2-bag FTP is: (4) Terms used in the equations in this paragraph (b) are defined as follows: Bag X/Y FE 75 = fuel economy in miles per gallon of fuel during combined phases X and Y of the FTP test conducted at an ambient temperature of 75 °F. Bag Y FE X = the fuel economy in miles per gallon of fuel during bag Y of the FTP test conducted at an ambient temperature X of 75 °F or 20 °F. HFET FE = fuel economy in miles per gallon over the HFET test. SC03 FE = fuel economy in mile per gallon over the SC03 test. US06 City FE = fuel economy in miles per gallon over the city portion of the US06 test. US06 Highway FE = fuel economy in miles per gallon over the highway portion of the US06 test. (d) City CO 2 emissions and carbon-related exhaust emissions. For each vehicle tested, determine the 5-cycle city CO 2 emissions and carbon-related exhaust emissions using the following equation: (2) To determine City CO 2 emissions, use the appropriate CO 2 gram/mile values expressed to the nearest 0.1 gram/mile instead of CREE values in the equations in this paragraph (d). The appropriate CO 2 values for fuel economy labels based on testing with E10 test fuel are the measured tailpipe CO 2 emissions for the test cycle multiplied by 1.0166. (3) Terms used in the equations in this paragraph (d) are defined as follows: Bag Y CREE X = the carbon-related exhaust emissions in grams per mile during bag Y of the FTP test conducted at an ambient temperature X of 75 °F or 20 °F. US06 City CREE = carbon-related exhaust emissions in grams per mile over the city portion of the US06 test. SC03 CREE = carbon-related exhaust emissions in grams per mile over the SC03 test. (e) Highway CO 2 emissions and carbon-related exhaust emissions. (1) For each vehicle tested, determine the 5-cycle highway carbon-related exhaust emissions using the following equation: (2) If the condition specified in § 600.115-08(b)(2)(iii)(B) is met, in lieu of using the calculation in paragraph (e)(1) of this section, the manufacturer may optionally determine the highway carbon-related exhaust emissions using the following modified 5-cycle equation which utilizes data from FTP, HFET, and US06 tests, and applies mathematic adjustments for Cold FTP and SC03 conditions: (i) Perform a US06 test in addition to the FTP and HFET tests. (ii) Determine the 5-cycle highway carbon-related exhaust emissions according to the following formula: Where: Start CREE 75 = 3.6 × (Bag 1CREE 75 − Bag 3CREE 75 ) Running CREE = 1.007 × [(0.79 × US06 Highway CREE) + (0.21 × HFET CREE)] + [0.377 × 0.133 × ((0.00540 × A) + (0.1357 × US06 CREE))] Where: Start CREE 75 = 3.6 × (Bag 1CREE 75 − Bag 3CREE 75 ) Running CREE = 1.007 × [(0.79 × US06 Highway CREE) + (0.21 × HFET CREE)] + [0.377 × 0.133 × ((0.00540 × A) + (0.1357 × US06 CREE))] (3) To determine Highway CO 2 emissions, use the appropriate CO 2 gram/mile values expressed to the nearest 0.1 gram/mile instead of CREE values in the equations in this paragraph (e) The appropriate CO 2 values for fuel economy labeling based on testing with E10 test fuel are the measured tailpipe CO 2 emissions for the test cycle multiplied by 1.0166. (4) Terms used in the equations in this paragraph (e) are defined as follows: A = 8,887 for gasoline-fueled vehicles, 10,180 for diesel-fueled vehicles, or an appropriate value specified by the Administrator for other fuels. Bag Y CREE X = the carbon-related exhaust emissions in grams per mile during bag Y of the FTP test conducted at an ambient temperature X of 75 °F or 20 °F. US06 Highway CREE = carbon-related exhaust emissions in grams per mile over the highway portion of the US06 test. US06 CREE = carbon-related exhaust emissions in grams per mile over the US06 test. HFET CREE = carbon-related exhaust emissions in grams per mile over the HFET test. SC03 CREE = carbon-related exhaust emissions in grams per mile over the SC03 test. (f) CO 2 and carbon-related exhaust emissions calculations for hybrid electric vehicles. Test hybrid electric vehicles as described in SAE J1711 (incorporated by reference in § 600.011). For FTP testing, this generally involves emission sampling over four phases (bags) of the UDDS (cold-start, transient, warm-start, transient); however, these four phases may be combined into two phases (phases 1 + 2 and phases 3 + 4). Calculations for these sampling methods follow: (1) If the 4-bag sampling method is used, manufacturers may use the equations in paragraphs (a) and (b) of this section to determine city and highway CO 2 and carbon-related exhaust emissions values. The appropriate CO 2 emission input values for fuel economy labeling based on testing with E10 test fuel are the measured tailpipe CO 2 emissions for the test cycle multiplied by 1.0166. If this method is chosen, it must be used to determine both city and highway CO 2 emissions and carbon-related exhaust emissions. Optionally, the following calculations may be used, provided that they are used to determine both city and highway CO 2 and carbon-related exhaust emissions values: (i) City CO 2 emissions and carbon-related exhaust emissions. (ii) Highway CO 2 emissions and carbon-related exhaust emissions. (2) If the 2-bag sampling method is used for the 75 °F FTP test, it must be used to determine both city and highway CO 2 emissions and carbon-related exhaust emissions. The appropriate CO 2 emission input values for fuel economy labeling based on testing with E10 test fuel are the measured tailpipe CO 2 emissions for the test cycle multiplied by 1.0166. The following calculations must be used to determine both city and highway CO 2 emissions and carbon-related exhaust emissions: (i) City CO 2 emissions and carbon-related exhaust emissions. (ii) Highway CO 2 emissions and carbon-related exhaust emissions. (3) For hybrid electric vehicles using the modified 5-cycle highway calculation in paragraph (e)(2) of this section, the equation in paragraph (e)(2)(ii)(A) of this section applies except that the equation for Start CREE 75 will be replaced with one of the following: (i) The equation for Start CREE 75 for hybrids tested according to the 4-bag FTP is: Start CREE 75 = 3.6 × (Bag 1 CREE 75 − Bag 3 CREE 75 + 3.9 × (Bag 2 CREE 75 − Bag 4 CREE 75 ) (ii) The equation for Start CREE 75 for hybrids tested according to the 2-bag FTP is: Start CREE 75 = 7.5 × (Bag 1/2 CREE 75 − Bag 3/4 CREE 75 ) (4) To determine City and Highway CO 2 emissions, use the appropriate CO 2 gram/mile values expressed to the nearest 0.1 gram/mile instead of CREE values in the equations in paragraphs (f)(1) through (3) of this section. (5) Terms used in the equations in this paragraph (e) are defined as follows: Bag Y CREE X = the carbon-related exhaust emissions in grams per mile during bag Y of the FTP test conducted at an ambient temperature X of 75 °F or 20 °F.US06 City CREE = carbon-related exhaust emissions in grams per mile over the City portion of the US06 test. SC03 CREE = carbon-related exhaust emissions in grams per mile over the SC03 test. US06 Highway CREE = carbon-related exhaust emissions in grams per mile over the Highway portion of the US06 test. HFET CREE = carbon-related exhaust emissions in grams per mile over the HFET test. Bag X/Y CREE 75 = carbon-related exhaust emissions in grams per mile of fuel during combined phases X and Y of the FTP test conducted at an ambient temperature of 75 °F." 40:40:32.0.1.4.44.2.13.6,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.115-11 Criteria for determining the fuel economy label calculation method.,EPA,,,"[76 FR 39547, July 6, 2011, as amended at 76 FR 57380, Sept. 15, 2011; 88 FR 4481, Jan. 24, 2023; 89 FR 28204, Apr. 18, 2024]","This section provides the criteria to determine if the derived 5-cycle method for determining fuel economy label values, as specified in § 600.210-08(a)(2) or (b)(2) or § 600.210-12(a)(2) or (b)(2), as applicable, may be used to determine label values. Separate criteria apply to city and highway fuel economy for each test group. The provisions of this section are optional. If this option is not chosen, or if the criteria provided in this section are not met, fuel economy label values must be determined according to the vehicle-specific 5-cycle method specified in § 600.210-08(a)(1) or (b)(1) or § 600.210-12(a)(1) or (b)(1), as applicable. However, dedicated alternative-fuel vehicles (other than battery electric vehicles and fuel cell vehicles), dual fuel vehicles when operating on the alternative fuel, MDPV FE , and vehicles imported by Independent Commercial Importers may use the derived 5-cycle method for determining fuel economy label values whether or not the criteria provided in this section are met. Manufacturers may alternatively account for this effect for battery electric vehicles, fuel cell vehicles, and plug-in hybrid electric vehicles (when operating in the charge-depleting mode) by multiplying 2-cycle fuel economy values by 0.7 and dividing 2-cycle CO 2 emission values by 0.7. (a) City fuel economy criterion. (1) For each test group certified for emission compliance under § 86.1848 of this chapter, the FTP, HFET, US06, SC03 and Cold FTP tests determined to be official under § 86.1835 of this chapter are used to calculate the vehicle-specific 5-cycle city fuel economy which is then compared to the derived 5-cycle city fuel economy, as follows: (i) The vehicle-specific 5-cycle city fuel economy from the official FTP, HFET, US06, SC03 and Cold FTP tests for the test group is determined according to the provisions of § 600.114-08(a) or (c) or § 600.114-12(a) or (c) and rounded to the nearest one tenth of a mile per gallon. (ii) Using the same FTP data as used in paragraph (a)(1)(i) of this section, the corresponding derived 5-cycle city fuel economy is calculated according to the following equation: Where: City Intercept = Intercept determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(iii). City Slope = Slope determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(ii). FTP FE = the FTP-based city fuel economy from the official test used for certification compliance, determined under § 600.113-08(a), rounded to the nearest tenth. Where: City Intercept = Intercept determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(iii). City Slope = Slope determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(ii). FTP FE = the FTP-based city fuel economy from the official test used for certification compliance, determined under § 600.113-08(a), rounded to the nearest tenth. (2) The derived 5-cycle fuel economy value determined in paragraph (a)(1)(ii) of this section is multiplied by 0.96 and rounded to the nearest one tenth of a mile per gallon. (3) If the vehicle-specific 5-cycle city fuel economy determined in paragraph (a)(1)(i) of this section is greater than or equal to the value determined in paragraph (a)(2) of this section, then the manufacturer may base the city fuel economy estimates for the model types covered by the test group on the derived 5-cycle method specified in § 600.210-08(a)(2) or (b)(2) or § 600.210-12(a)(2) or (b)(2), as applicable. (b) Highway fuel economy criterion. The determination for highway fuel economy depends upon the outcome of the determination for city fuel economy in paragraph (a)(3) of this section for each test group. (1) If the city determination for a test group made in paragraph (a)(3) of this section does not allow the use of the derived 5-cycle method, then the highway fuel economy values for all model types represented by the test group are likewise not allowed to be determined using the derived 5-cycle method, and must be determined according to the vehicle-specific 5-cycle method specified in § 600.210-08(a)(1) or (b)(1) or § 600.210-12(a)(1) or (b)(1), as applicable. (2) If the city determination made in paragraph (a)(3) of this section allows the use of the derived 5-cycle method, a separate determination is made for the highway fuel economy labeling method as follows: (i) For each test group certified for emission compliance under § 86.1848 of this chapter, the FTP, HFET, US06, SC03 and Cold FTP tests determined to be official under § 86.1835 of this chapter are used to calculate the vehicle-specific 5-cycle highway fuel economy, which is then compared to the derived 5-cycle highway fuel economy, as follows: (A) The vehicle-specific 5-cycle highway fuel economy from the official FTP, HFET, US06, SC03 and Cold FTP tests for the test group is determined according to the provisions of § 600.114-08(b)(1) or § 600.114-12(b)(1) and rounded to the nearest one tenth of a mile per gallon. (B) Using the same HFET data as used in paragraph (b)(2)(i)(A) of this section, the corresponding derived 5-cycle highway fuel economy is calculated using the following equation: Where: Highway Intercept = Intercept determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(iii). Highway Slope = Slope determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(iii). HFET FE = the HFET-based highway fuel economy determined under § 600.113-08(b), rounded to the nearest tenth. Where: Highway Intercept = Intercept determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(iii). Highway Slope = Slope determined by the Administrator. See § 600.210-08(a)(2)(iii) or § 600.210-12(a)(2)(iii). HFET FE = the HFET-based highway fuel economy determined under § 600.113-08(b), rounded to the nearest tenth. (ii) The derived 5-cycle highway fuel economy calculated in paragraph (b)(2)(i)(B) of this section is multiplied by 0.95 and rounded to the nearest one tenth of a mile per gallon. (iii) (A) If the vehicle-specific 5-cycle highway fuel economy of the vehicle tested in paragraph (b)(2)(i)(A) of this section is greater than or equal to the value determined in paragraph (b)(2)(ii) of this section, then the manufacturer may base the highway fuel economy estimates for the model types covered by the test group on the derived 5-cycle method specified in § 600.210-08(a)(2) or (b)(2) or § 600.210-12(a)(2) or (b)(2), as applicable. (B) If the vehicle-specific 5-cycle highway fuel economy determined in paragraph (b)(2)(i)(A) of this section is less than the value determined in paragraph (b)(2)(ii) of this section, the manufacturer may determine the highway fuel economy for the model types covered by the test group on the modified 5-cycle equation specified in § 600.114-08(b)(2) or § 600.114-12(b)(2). (c) The manufacturer will apply the criteria in paragraph (a) and (b) of this section to every test group for each model year. (d) The tests used to make the evaluations in paragraphs (a) and (b) of this section will be the procedures for official test determinations under § 86.1835. Adjustments and/or substitutions to the official test data may be made with advance approval of the Administrator." 40:40:32.0.1.4.44.2.13.7,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.116-12 Special procedures related to electric vehicles and hybrid electric vehicles.,EPA,,,"[76 FR 39548, July 6, 2011, as amended at 76 FR 57380, Sept. 15, 2011; 77 FR 63182, Oct. 15, 2012; 79 FR 23747, Apr. 28, 2014; 80 FR 9111, Feb. 19, 2015; 81 FR 74001, Oct. 25, 2016; 88 FR 4481, Jan. 24, 2023; 89 FR 28204, Apr. 18, 2024]","(a) Determine fuel economy values for electric vehicles as specified in §§ 600.210 and 600.311 using the procedures of SAE J1634 (incorporated by reference in § 600.011). Use the procedures of SAE J1634, Section 8, with the following clarifications and modifications for using this and other sections of SAE J1634: (1) Vehicles that cannot complete the Multi-Cycle Range and Energy Consumption Test (MCT) because they are unable travel the distance required to complete the test with a fully charged battery, or they are unable to achieve the maximum speed on either the UDDS or HFEDS (Highway Fuel Economy Drive Cycle also known as the HFET) cycle should seek Administrator approval to use the procedures outlined in SAE J1634 Section 7 Single Cycle Range and Energy Consumption Test (SCT). (2) The MCT includes the following key-on soak times and key-off soak periods: (i) As noted in SAE J1634 Section 8.3.4, a 15 second key-on pause is required between UDDS 1 and HFEDS 1 , and UDDS 3 and HFEDS 2 . (ii) As noted in SAE J1634 Section 8.3.4, a 10-minute key-off soak period is required between HFEDS 1 and UDDS 2 , and HFEDS 2 and UDDS 4 . (iii) A key-off soak period up to 30 minutes may be inserted between UDDS 2 and the first phase of the mid-test constant speed cycle, between UDDS 4 and the first phase of the end-of-test constant speed cycle, and between the end of the mid-test constant speed cycle and UDDS 3 . Start the next test segment immediately if there is no key-off soak between test segments. (iv) If multiple phases are required during either the mid-test constant speed cycle or the end-of-test constant speed cycle there must be a 5-minute to 30-minute key-off soak period between each constant speed phase as noted in SAE J1634 Section 6.6. (3) As noted in SAE J1634 Section 8.3.4, during all `key-off' soak periods, the key or power switch must be in the “off” position, the hood must be closed, the test cell fan(s) must be off, and the brake pedal not depressed. For vehicles which do not have a key or power switch the vehicle must be placed in the `mode' the manufacturer recommends when the vehicle is to be parked and the occupants exit the vehicle. (4) Manufacturers may determine the mid-test constant speed cycle distance (d M ) using their own methodology and good engineering judgment. Otherwise, either Method 1 or Method 2 described in Appendix A of SAE J1634 may be used to estimate the mid-test constant speed cycle distance (d M ). The mid-test constant speed cycle distance calculation needs to be performed prior to beginning the test and should not use data from the test being performed. If Method 2 is used, multiply the result determined by the Method 2 equation by 0.8 to determine the mid-test constant speed cycle distance (d M ). (5) Divide the mid-test constant speed cycle distance (d M ) by 65 mph to determine the total time required for the mid-test constant speed cycle. If the time required is one hour or less, the mid-test constant speed cycle can be performed with no key-off soak periods. If the time required is greater than one hour, the mid-test constant speed cycle must be separated into phases such that no phase exceeds more than one hour. At the conclusion of each mid-test constant speed phase, except at the conclusion of the mid-test constant speed cycle, perform a 5-minute to 30-minute key-off soak. A key-off soak period up to 30 minutes may be inserted between the end of the mid-test constant speed cycle and UDDS 3 . (6) Using good engineering judgment determine the end-of-test constant speed cycle distance so that it does not exceed 20% of the total distance driven during the MCT as described in SAE J1634 Section 8.3.3. (7) Divide the end-of-test constant speed cycle distance (d E ) by 65 mph to determine the total time required for the end-of-test constant speed cycle. If the time required is one-hour or less the end-of-test constant speed cycle can be performed with no key-off soak periods. If the time required is greater than one-hour the end-of-test constant speed cycle must be separated into phases such that no phase exceeds more than one-hour. At the conclusion of each end-of-test constant speed phase, perform a 5-minute to 30-minute key-off soak. (8) SAE J1634 Section 3.13 defines useable battery energy (UBE) as the total DC discharge energy (Edc total ), measured in DC watt-hours for a full discharge test. The total DC discharge energy is the sum of all measured phases of a test inclusive of all drive cycle types. As key-off soak periods are not considered part of the test phase, the discharge energy that occurs during the key-off soak periods is not included in the useable battery energy. (9) Recharging the vehicle's battery must start within three hours after the end of testing. (10) At the request of a manufacturer, the Administrator may approve the use of an earlier version of SAE J1634 when a manufacturer is carrying over data for vehicles tested using a prior version of SAE J1634. (11) All label values related to fuel economy, energy consumption, and range must be based on 5-cycle testing or on values adjusted to be equivalent to 5-cycle results. Prior to performing testing to generate a 5-cycle adjustment factor, manufacturers must request Administrator approval to use SAE J1634 Appendices B and C for determining a 5-cycle adjustment factor with the following modifications, clarifications, and attestations: (i) Before model year 2025, prior to performing the 20 °F charge-depleting UDDS, the vehicle must soak for a minimum of 12 hours and a maximum of 36 hours at a temperature of 20 °F. Prior to beginning the 12 to 36 hour cold soak at 20 °F the vehicle must be fully charged, the charging can take place at test laboratory ambient temperatures (68 to 86 °F) or at 20 °F. During the 12 to 36 hour cold soak period the vehicle may not be connected to a charger nor is the vehicle cabin or battery to be preconditioned during the 20 °F soak period. (ii) Beginning with model year 2025, the 20 °F UDDS charge-depleting UDDS test will be replaced with a 20 °F UDDS test consisting of two UDDS cycles performed with a 10-minute key-off soak between the two UDDS cycles. The data from the two UDDS cycles will be used to calculate the five-cycle adjustment factor, instead of using the results from the entire charge-depleting data set. Manufacturers that have submitted and used the average data from 20 °F charge-depleting UDDS data sets will be required to revise their 5-cycle adjustment factor calculation and re-label vehicles using the data from the first two UDDS cycles only. Manufacturers, at their discretion, would also be allowed to re-run the 20 °F UDDS test with the battery charged to a state-of-charge (SoC) determined by the manufacturer. The battery does not need to be at 100% SoC before the 20 °F cold soak. (iii) Manufacturers must submit a written attestation to the Administrator at the completion of testing with the following information: (A) A statement noting the SoC level of the rechargeable energy storage system (RESS) prior to beginning the 20 °F cold soak for testing performed beginning with model year 2025. (B) A statement confirming the vehicle was not charged or preconditioned during the 12 to 36 hour 20 °F soak period before starting the 20 °F UDDS cycle. (C) A summary of all the 5-cycle test results and the calculations used to generate the 5-cycle adjustment factor, including all the 20 °F UDDS cycles, the distance travelled during each UDDS and the measured DC discharge energy during each UDDS phase. Beginning in model year 2025, the 20 °F UDDS test results will consist of only two UDDS cycles. (D) Beginning in model year 2025, calculate City Fuel Economy using the following equation for RunningFC instead of the equation on Page 30 in Appendix C of SAE J1634: (E) A description of each test group and configuration which will use the 5-cycle adjustment factor, including the battery capacity of the vehicle used to generate the 5-cycle adjustment factor and the battery capacity of all the configurations to which it will be applied. (iv) At the conclusion of the manufacturers testing and after receiving the attestations from the manufacturer regarding the performance of the 20 °F UDDS test processes, the 5-cycle test results, and the summary of vehicles to which the manufacturer proposes applying the 5-cycle adjustment factor, the Administrator will review the submittals and inform the manufacturer in writing if the Administrator concurs with the manufacturer's proposal. If not, the Administrator will describe the rationale to the manufacturer for not approving their request. (b) Determine performance values for hybrid electric vehicles that have no plug-in capability as specified in §§ 600.210 and 600.311 using the procedures for charge-sustaining operation from SAE J1711 (incorporated by reference in § 600.011). We may approve alternate measurement procedures with respect to these vehicles if that is necessary or appropriate for meeting the objectives of this part. For example, we may approve alternate Net Energy Change/Fuel Ratio tolerances for charge-sustaining operation as described in paragraph (c)(5) of this section. (c) Determine performance values for hybrid electric vehicles that have plug-in capability as specified in §§ 600.210 and 600.311 using the procedures of SAE J1711 (incorporated by reference in § 600.011), with the following clarifications and modifications: (1) To determine CREE values to demonstrate compliance with GHG standards, calculate composite values representing combined operation during charge-depleting and charge-sustaining operation using the following utility factors, except as otherwise specified in this paragraph (c): Table 1 to Paragraph (c)(1) —Fleet Utility Factors for Urban “City” Driving Table 2 to paragraph (c)(1) —Fleet Utility Factors for Highway Driving (2) Determine fuel economy values to demonstrate compliance with CAFE standards as follows: (i) For vehicles that are not dual fueled automobiles, determine fuel economy using the utility factors specified in paragraph (c)(1) of this section for model year 2030 and earlier vehicles. Do not use the petroleum-equivalence factors described in 10 CFR 474.3. (ii) Except as described in paragraph (c)(2)(iii) of this section, determine fuel economy for dual fueled automobiles from the following equation, separately for city and highway driving: Where: MPG gas = The miles per gallon measured while operating on gasoline during charge-sustaining operation as determined using the procedures of SAE J1711. MPGe elec = The miles per gallon equivalent measured while operating on electricity. Calculate this value by dividing the equivalent all-electric range determined from the equation in § 86.1866-12(b)(2)(ii) by the corresponding measured Watt-hours of energy consumed; apply the appropriate petroleum-equivalence factor from 10 CFR 474.3 to convert Watt-hours to gallons equivalent. Note that if vehicles use no gasoline during charge-depleting operation, MPGe elec is the same as the charge-depleting fuel economy specified in SAE J1711. Where: MPG gas = The miles per gallon measured while operating on gasoline during charge-sustaining operation as determined using the procedures of SAE J1711. MPGe elec = The miles per gallon equivalent measured while operating on electricity. Calculate this value by dividing the equivalent all-electric range determined from the equation in § 86.1866-12(b)(2)(ii) by the corresponding measured Watt-hours of energy consumed; apply the appropriate petroleum-equivalence factor from 10 CFR 474.3 to convert Watt-hours to gallons equivalent. Note that if vehicles use no gasoline during charge-depleting operation, MPGe elec is the same as the charge-depleting fuel economy specified in SAE J1711. (iii) For 2016 and later model year dual fueled automobiles, you may determine fuel economy based on the following equation, separately for city and highway driving: Where: UF = The appropriate utility factor for city or highway driving specified in paragraph (c)(1) of this section for model year 2030 and earlier vehicles. Where: UF = The appropriate utility factor for city or highway driving specified in paragraph (c)(1) of this section for model year 2030 and earlier vehicles. (3) To determine fuel economy and CO 2 emission values for labeling purposes, calculate composite values representing combined operation during charge-depleting and charge-sustaining operation using the following utility factors except as specified in this paragraph (c): Table 3 of § 600.116-12—Multi-Day Individual Utility Factors for Urban “City” Driving Table 4 of § 600.116-12—Multi-Day Individual Utility Factors for Highway Driving (4) You may calculate performance values under paragraphs (c)(1) through (3) of this section by combining phases during FTP testing. For example, you may treat the first 7.45 miles as a single phase by adding the individual utility factors for that portion of driving and assigning emission levels to the combined phase. Do this consistently throughout a test run. (5) Instead of the utility factors specified in paragraphs (c)(1) through (3) of this section, calculate utility factors using the following equation for vehicles whose maximum speed is less than the maximum speed specified in the driving schedule, where the vehicle's maximum speed is determined, to the nearest 0.1 mph, from observing the highest speed over the first duty cycle (FTP, HFET, etc.): Where: UF i = the utility factor for phase i. Let UF 0 = 0. j = a counter to identify the appropriate term in the summation (with terms numbered consecutively). k = the number of terms in the equation (see Table 5 of this section). d i = the distance driven in phase i. ND = the normalized distance. Use 399 for both FTP and HFET operation for CAFE and GHG fleet values, except that ND = 583 for both FTP and HFET operation for GHG fleet values starting in model year 2031. Use 399 for both FTP and HFET operation for multi-day individual values for labeling. C j = the coefficient for term j from the following table: Where: UF i = the utility factor for phase i. Let UF 0 = 0. j = a counter to identify the appropriate term in the summation (with terms numbered consecutively). k = the number of terms in the equation (see Table 5 of this section). d i = the distance driven in phase i. ND = the normalized distance. Use 399 for both FTP and HFET operation for CAFE and GHG fleet values, except that ND = 583 for both FTP and HFET operation for GHG fleet values starting in model year 2031. Use 399 for both FTP and HFET operation for multi-day individual values for labeling. C j = the coefficient for term j from the following table: Table 5 to Paragraph (c)(5) —City/Highway Specific Utility Factor Coefficients n = the number of test phases (or bag measurements) before the vehicle reaches the end-of-test criterion. n = the number of test phases (or bag measurements) before the vehicle reaches the end-of-test criterion. (6) Determine End-of-Test as follows: (i) Base End-of-Test on a 2 percent State of Charge as specified in Section 3.5.1 of SAE J1711. (ii) Base End-of-Test on a 1 percent Net Energy Change/Fuel Ratio as specified in Section 3.5.2 of SAE J1711. (iii) For charge-sustaining tests, we may approve alternate Net Energy Change/Fuel Ratio tolerances as specified in Appendix C of SAE J1711 to correct final fuel economy values, CO 2 emissions, and carbon-related exhaust emissions. For charge-sustaining tests, do not use alternate Net Energy Change/Fuel Ratio tolerances to correct emissions of criteria pollutants. Additionally, if we approve an alternate End-of-Test criterion or Net Energy Change/Fuel Ratio tolerances for a specific vehicle, we may use the alternate criterion or tolerances for any testing we conduct on that vehicle. (7) Use the vehicle's Actual Charge-Depleting Range, Rcda, as specified in Section 7.1.4 of SAE J1711 for evaluating the end-of-test criterion. (8) Measure and record AC watt-hours throughout the recharging procedure. Position the measurement appropriately to account for any losses in the charging system. (9) We may approve alternate measurement procedures with respect to plug-in hybrid electric vehicles if they are necessary or appropriate for meeting the objectives of this part. (10) The utility factors described in this paragraph (c) and in § 600.510 are derived from equations in SAE J2841. You may alternatively calculate utility factors from the corresponding equations in SAE J2841 as follows: (i) Calculate utility factors for labeling directly from the equation in SAE J2841 Section 6.2 using the Table 2 MDIUF Fit Coefficients (C1 through C10) and a normalized distance (norm_dist) of 399 miles. (ii) Calculate utility factors for fuel economy standards from the equation in SAE J2841 Section 6.2 using the Table 5 Fit Coefficients for city/Hwy Specific FUF curves weighted 55 percent city, 45 percent highway and a normalized distance (norm_dist) of 399 miles. (iii) Starting in model year 2031, calculate utility factors for GHG compliance with emission standards from the equation in SAE J2841 Section 6.2 using the Table 2 FUF Fit Coefficients (C1 through C6) and a normalized distance (norm_dist) of 583 miles. For model year 2026 and earlier, calculate utility factors for compliance with GHG emission standards as described in paragraph (c)(10)(ii) of this section. (11) The following methodology is used to determine the usable battery energy (UBE) for a PHEV using data obtained during either the UDDS Full Charge Test (FCT) or the HFET FCT as described in SAE J1711: (i) Perform the measurements described in SAE J1711 Section 5.1.3.d. Record initial and final SOC of the RESS for each cycle in the FCT. (ii) Perform the measurements described in SAE J1711 Section 5.1.3.c. Continuously measure the voltage of the RESS throughout the entire cycle, or record initial and final voltage measurements of the RESS for each test cycle. (iii) Determine average voltage of the RESS during each FCT cycle by averaging the results of the continuous voltage measurement or by determining the average of the initial and final voltage measurement. (iv) Determine the DC discharge energy for each cycle of the FCT by multiplying the change in SOC of each cycle by the average voltage for the cycle. (v) Instead of independently measuring current and voltage and calculating the resulting DC discharge energy, you may use a DC wideband Watt-hour meter (power analyzer) to directly measure the DC discharge energy of the RESS during each cycle of the FCT. The meter used for this measurement must meet the requirements in SAE J1711 Section 4.4. (vi) After completing the FCT, determine the cycles comprising the Charge-Depleting Cycle Range (Rcdc) as described in SAE J1711 Section 3.1.14. Charge-sustaining cycles are not included in the Rcdc. Rcdc includes any number of transitional cycles where the vehicle may have operated in both charge-depleting and charge-sustaining modes. (vii) Determine the UBE of the PHEV by summing the measured DC discharge energy for each cycle comprising Rcdc. Following the charge-depleting cycles and during the transition to charge-sustaining operation, one or more of the transition cycles may result in negative DC discharge energy measurements that result from the vehicle charging and not discharging the RESS. Include these negative discharge results in the summation. (d) Determining the proportion of recovered energy for hybrid electric vehicles. Testing of hybrid electric vehicles under this part may include a determination of the proportion of energy recovered over the FTP relative to the total available braking energy required over the FTP. This determination is required for pickup trucks accruing credits for implementation of hybrid technology under § 86.1870-12, and requires the measurement of electrical current (in amps) flowing into the hybrid system battery for the duration of the test. Hybrid electric vehicles are tested for fuel economy and GHG emissions using the 4-bag FTP as required by § 600.114(c). Alternative measurement and calculation methods may be used with prior EPA approval. (1) Calculate the theoretical maximum amount of energy that could be recovered by a hybrid electric vehicle over the FTP test cycle, where the test cycle time and velocity points are expressed at 10 Hz, and the velocity (miles/hour) is expressed to the nearest 0.01 miles/hour, as follows: (i) For each time point in the 10 Hz test cycle ( i.e. , at each 0.1 seconds): (A) Determine the road load power in kilowatts using the following equation: Where: P roadload is the road load power in kilowatts, where road load is negative because it always represents a deceleration ( i.e. , resistive) force on the vehicle; A, B, and C are the vehicle-specific dynamometer road load coefficients in lb-force, lb-force/mph, and lb-force/mph 2 , respectively; V mph = velocity in miles/hour, expressed to the nearest 0.01 miles/hour; 0.44704 converts speed from miles/hour to meters/second; 4.448 converts pound force to Newtons; and 1,000 converts power from Watts to kilowatts. Where: P roadload is the road load power in kilowatts, where road load is negative because it always represents a deceleration ( i.e. , resistive) force on the vehicle; A, B, and C are the vehicle-specific dynamometer road load coefficients in lb-force, lb-force/mph, and lb-force/mph 2 , respectively; V mph = velocity in miles/hour, expressed to the nearest 0.01 miles/hour; 0.44704 converts speed from miles/hour to meters/second; 4.448 converts pound force to Newtons; and 1,000 converts power from Watts to kilowatts. (B) Determine the applied deceleration power at each sampling point in time, t, in kilowatts, using the following equation. Positive values indicate acceleration and negative values indicate deceleration. Where: ETW = the vehicle Equivalent Test Weight (lbs); V t = velocity in miles/hour, rounded to the nearest 0.01 miles/hour, at each sampling point; V t-1 = the velocity in miles/hour at the previous time point in the 10 Hz speed vs. time table, rounded to the nearest 0.01 miles/hour; 0.1 represents the time in seconds between each successive velocity data point; 0.44704 converts speed from miles/hour to meters/second; 2.205 converts weight from pounds to kilograms; and 1,000 converts power from Watts to kilowatts. Where: ETW = the vehicle Equivalent Test Weight (lbs); V t = velocity in miles/hour, rounded to the nearest 0.01 miles/hour, at each sampling point; V t-1 = the velocity in miles/hour at the previous time point in the 10 Hz speed vs. time table, rounded to the nearest 0.01 miles/hour; 0.1 represents the time in seconds between each successive velocity data point; 0.44704 converts speed from miles/hour to meters/second; 2.205 converts weight from pounds to kilograms; and 1,000 converts power from Watts to kilowatts. (C) Determine braking power in kilowatts using the following equation. Note that during braking events, P brake , P accel , and P roadload will all be negative ( i.e., resistive) forces on the vehicle. P brake = P accel − P roadload Where: P accel = the value determined in paragraph (d)(1)(i)(B) of this section; P roadload = the value determined in paragraph (d)(1)(i)(A) of this section; and P brake = 0 if P accel is greater than or equal to P roadload . Where: P accel = the value determined in paragraph (d)(1)(i)(B) of this section; P roadload = the value determined in paragraph (d)(1)(i)(A) of this section; and P brake = 0 if P accel is greater than or equal to P roadload . (ii) The total maximum braking energy ( E brake ) that could theoretically be recovered is equal to the absolute value of the sum of all the values of P brake determined in paragraph (d)(1)(i)(C) of this section, divided by 36000 (to convert 10 Hz data to hours) and rounded to the nearest 0.01 kilowatt-hours. (ii) The total maximum braking energy (E brake ) that could theoretically be recovered is equal to the absolute value of the sum of all the values of P brake determined in paragraph (c)(1)(i)(C) of this section, divided by 36000 (to convert 10 Hz data to hours) and rounded to the nearest 0.01 kilowatt hours. (2) Calculate the actual amount of energy recovered (E rec ) by a hybrid electric vehicle when tested on the FTP according to the provisions of this part, as follows: (i) Measure the electrical current in Amps to and from the hybrid electric vehicle battery during the FTP. Measurements should be made directly upstream of the battery at a 10 Hz sampling rate. (ii) At each sampling point where current is flowing into the battery, calculate the energy flowing into the battery, in Watt-hours, as follows: Where: E t = the energy flowing into the battery, in Watt-hours, at time t in the test; I t = the electrical current, in Amps, at time t in the test; and V nominal = the nominal voltage of the hybrid battery system determined according to paragraph (d)(4) of this section. Where: E t = the energy flowing into the battery, in Watt-hours, at time t in the test; I t = the electrical current, in Amps, at time t in the test; and V nominal = the nominal voltage of the hybrid battery system determined according to paragraph (d)(4) of this section. (iii) The total energy recovered (E rec ) is the absolute value of the sum of all values of E t that represent current flowing into the battery, divided by 1000 (to convert Watt-hours to kilowatt-hours). (3) The percent of braking energy recovered by a hybrid system relative to the total available energy is determined by the following equation, rounded to the nearest one percent: Where: E rec = The actual total energy recovered, in kilowatt-hours, as determined in paragraph (d)(2) of this section; and E brake = The theoretical maximum amount of energy, in kilowatt-hours, that could be recovered by a hybrid electric vehicle over the FTP test cycle, as determined in paragraph (d)(1) of this section. Where: E rec = The actual total energy recovered, in kilowatt-hours, as determined in paragraph (d)(2) of this section; and E brake = The theoretical maximum amount of energy, in kilowatt-hours, that could be recovered by a hybrid electric vehicle over the FTP test cycle, as determined in paragraph (d)(1) of this section. (4)(i) Determination nominal voltage (V nominal ) using the following equation: Where: V S is the battery voltage measured at the start of the FTP test, where the measurement is made after the key-on event but not later than 10 seconds after the key-on event; and V F is the battery voltage measured at the conclusion of the FTP test, where the measurement is made before the key-off event but not earlier than 10 seconds prior to the key-off event. Where: V S is the battery voltage measured at the start of the FTP test, where the measurement is made after the key-on event but not later than 10 seconds after the key-on event; and V F is the battery voltage measured at the conclusion of the FTP test, where the measurement is made before the key-off event but not earlier than 10 seconds prior to the key-off event. (ii) If the absolute value of the measured current to and from the battery during the measurement of either V S or V F exceeds three percent of the maximum absolute value of the current measured over the FTP, then that V S or V F value is not valid. If no valid voltage measurement can be made using this method, the manufacturer must develop an alternative method of determining nominal voltage. The alternative must be developed using good engineering judgment and is subject to EPA approval." 40:40:32.0.1.4.44.2.13.8,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,B,Subpart B—Fuel Economy and Carbon-Related Exhaust Emission Test Procedures,,§ 600.117 Interim provisions.,EPA,,,"[89 FR 28207, Apr. 18, 2024]","(a) The following provisions apply instead of other provisions specified in this part through model year 2026: (1) Except as specified in paragraphs (a)(5) and (6) of this section, manufacturers must demonstrate compliance with greenhouse gas emission standards and determine fuel economy values using E0 gasoline test fuel as specified in 40 CFR 86.113-04(a)(1), regardless of any testing with E10 test fuel specified in 40 CFR 1065.710(b) under paragraph (a)(2) of this section. (2) Manufacturers may demonstrate that vehicles comply with emission standards for criteria pollutants as specified in 40 CFR part 86, subpart S, during fuel economy measurements using the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1), as long as this test fuel is used in fuel economy testing for all applicable duty cycles specified in 40 CFR part 86, subpart S. If a vehicle fails to meet an emission standard for a criteria pollutant using the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1), the manufacturer must retest the vehicle using the E10 test fuel specified in 40 CFR 1065.710(b) (or the equivalent LEV III test fuel for California) to demonstrate compliance with all applicable emission standards over that test cycle. (3) If a manufacturer demonstrates compliance with emission standards for criteria pollutants over all five test cycles using the E10 test fuel specified in 40 CFR 1065.710(b) (or the equivalent LEV III test fuel for California), the manufacturer may use test data with the same test fuel to determine whether a test group meets the criteria described in § 600.115 for derived 5-cycle testing for fuel economy labeling. Such vehicles may be tested over the FTP and HFET cycles with the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1) under this paragraph (a)(3); the vehicles must meet the emission standards for criteria pollutants over those test cycles as described in paragraph (a)(2) of this section. (4) Manufacturers may perform testing with the appropriate gasoline test fuels specified in 40 CFR 86.113-04(a)(1), 40 CFR 86.213(a)(2), and in 40 CFR 1065.710(b) to evaluate whether their vehicles meet the criteria for derived 5-cycle testing under § 600.115. All five tests must use test fuel with the same nominal ethanol concentration. (5) For IUVP testing under 40 CFR 86.1845, manufacturers may demonstrate compliance with greenhouse gas emission standards using a test fuel meeting specifications for demonstrating compliance with emission standards for criteria pollutants. (6) Manufacturers may alternatively demonstrate compliance with greenhouse gas emission standards and determine fuel economy values using E10 gasoline test fuel as specified in 40 CFR 1065.710(b). However, manufacturers must then multiply measured CO 2 results by 1.0166 and round to the nearest 0.01 g/mile and calculate fuel economy using the equations appropriate equation for testing with E10 test fuel. (7) If a vehicle uses an E10 test fuel for evaporative emission testing and E0 is the applicable test fuel for exhaust emission testing, exhaust measurement and reporting requirements apply over the course of the evaporative emission test, but the vehicle need not meet the exhaust emission standards during the evaporative emission test run. (b) Manufacturers may certify model year 2027 through 2029 vehicles to greenhouse gas emission standards using data with E0 test fuel from testing for earlier model years, subject to the carryover provisions of 40 CFR 86.1839. In the case of the fleet average CO 2 standard, manufacturers must divide the measured CO 2 results by 1.0166 and round to the nearest 0.01 g/mile. (c) Manufacturers may perform testing under § 600.115-11 using E0 gasoline test fuel as specified in 40 CFR 86.113-04(a)(1) or E10 test fuel as specified in 40 CFR 1065.710(b) until EPA publishes guidance under § 600.210-12(a)(2)(iv) describing when and how to apply 5-cycle adjustment factors based on testing with the E10 test fuel." 40:40:32.0.1.4.44.3.13.1,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,C,Subpart C—Procedures for Calculating Fuel Economy and Carbon-Related Exhaust Emission Values,,"§ 600.206-12 Calculation and use of FTP-based and HFET-based fuel economy, CO",EPA,,,"[76 FR 39551, July 6, 2011, as amended at 89 FR 28207, Apr. 18, 2024]","(a) Fuel economy, CO 2 emissions, and carbon-related exhaust emissions values determined for each vehicle under § 600.113-08(a) and (b) and as approved in § 600.008(c), are used to determine FTP-based city, HFET-based highway, and combined FTP/Highway-based fuel economy, CO 2 emissions, and carbon-related exhaust emission values for each vehicle configuration for which data are available. Note that fuel economy for some alternative fuel vehicles may mean miles per gasoline gallon equivalent and/or miles per unit of fuel consumed. For example, electric vehicles will determine miles per kilowatt-hour in addition to miles per gasoline gallon equivalent, and fuel cell vehicles will determine miles per kilogram of hydrogen. (1) If only one set of FTP-based city and HFET-based highway fuel economy values is accepted for a subconfiguration at which a vehicle configuration was tested, these values, rounded to the nearest tenth of a mile per gallon, comprise the city and highway fuel economy values for that subconfiguration. If only one set of FTP-based city and HFET-based highway CO 2 emissions and carbon-related exhaust emission values is accepted for a subconfiguration at which a vehicle configuration was tested, these values, rounded to the nearest gram per mile, comprise the city and highway CO 2 emissions and carbon-related exhaust emission values for that subconfiguration. The appropriate CO 2 values for fuel economy labels based on testing with E10 test fuel are the measured tailpipe CO 2 emissions for the test cycle multiplied by 1.0166. (2) If more than one set of FTP-based city and HFET-based highway fuel economy and/or carbon-related exhaust emission values are accepted for a vehicle configuration: (i) All data shall be grouped according to the subconfiguration for which the data were generated using sales projections supplied in accordance with § 600.208-12(a)(3). (ii) Within each group of data, all fuel economy values are harmonically averaged and rounded to the nearest 0.0001 of a mile per gallon and all CO 2 emissions and carbon-related exhaust emission values are arithmetically averaged and rounded to the nearest tenth of a gram per mile in order to determine FTP-based city and HFET-based highway fuel economy, CO 2 emissions, and carbon-related exhaust emission values for each subconfiguration at which the vehicle configuration was tested. The appropriate CO 2 values for fuel economy labels based on testing with E10 test fuel are the measured tailpipe CO 2 emissions for the test cycle multiplied by 1.0166. (iii) All FTP-based city fuel economy, CO 2 emissions, and carbon-related exhaust emission values and all HFET-based highway fuel economy and carbon-related exhaust emission values calculated in paragraph (a)(2)(ii) of this section are (separately for city and highway) averaged in proportion to the sales fraction (rounded to the nearest 0.0001) within the vehicle configuration (as provided to the Administrator by the manufacturer) of vehicles of each tested subconfiguration. Fuel economy values shall be harmonically averaged, and CO 2 emissions and carbon-related exhaust emission values shall be arithmetically averaged. The resultant fuel economy values, rounded to the nearest 0.0001 mile per gallon, are the FTP-based city and HFET-based highway fuel economy values for the vehicle configuration. The resultant CO 2 emissions and carbon-related exhaust emission values, rounded to the nearest tenth of a gram per mile, are the FTP-based city and HFET-based highway CO 2 emissions and carbon-related exhaust emission values for the vehicle configuration. Note that the appropriate vehicle subconfiguration CO 2 values for fuel economy labels based on testing with E10 test fuel are adjusted as described in paragraph (a)(1) or (a)(2)(ii) of this section. (3)(i) For the purpose of determining average fuel economy under § 600.510, the combined fuel economy value for a vehicle configuration is calculated by harmonically averaging the FTP-based city and HFET-based highway fuel economy values, as determined in paragraph (a)(1) or (2) of this section, weighted 0.55 and 0.45 respectively, and rounded to the nearest 0.0001 mile per gallon. A sample of this calculation appears in appendix II to this part. (ii) For the purpose of determining average carbon-related exhaust emissions under § 600.510, the combined carbon-related exhaust emission value for a vehicle configuration is calculated by arithmetically averaging the FTP-based city and HFET-based highway carbon-related exhaust emission values, as determined in paragraph (a)(1) or (2) of this section, weighted 0.55 and 0.45 respectively, and rounded to the nearest tenth of gram per mile. (4) For alcohol dual fuel automobiles and natural gas dual fuel automobiles the procedures of paragraphs (a)(1) or (2) of this section, as applicable, shall be used to calculate two separate sets of FTP-based city, HFET-based highway, and combined values for fuel economy, CO 2 emissions, and carbon-related exhaust emissions for each configuration. (i) Calculate the city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emission values from the tests performed using gasoline or diesel test fuel. (ii) Calculate the city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emission values from the tests performed using alcohol or natural gas test fuel. (b) If only one equivalent petroleum-based fuel economy value exists for an electric vehicle configuration, that value, rounded to the nearest tenth of a mile per gallon, will comprise the petroleum-based fuel economy for that configuration. (c) If more than one equivalent petroleum-based fuel economy value exists for an electric vehicle configuration, all values for that vehicle configuration are harmonically averaged and rounded to the nearest 0.0001 mile per gallon for that configuration." 40:40:32.0.1.4.44.3.13.2,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,C,Subpart C—Procedures for Calculating Fuel Economy and Carbon-Related Exhaust Emission Values,,§ 600.207-12 Calculation and use of vehicle-specific 5-cycle-based fuel economy and CO,EPA,,,"[76 FR 39551, July 6, 2011, as amended at 89 FR 28208, Apr. 18, 2024]","(a) Fuel economy and CO 2 emission values determined for each vehicle under § 600.114 and as approved in § 600.008(c), are used to determine vehicle-specific 5-cycle city and highway fuel economy and CO 2 emission values for each vehicle configuration for which data are available. (1) If only one set of 5-cycle city and highway fuel economy and CO 2 emission values is accepted for a vehicle configuration, these values, where fuel economy is rounded to the nearest 0.0001 of a mile per gallon and the CO 2 emission value in grams per mile is rounded to the nearest tenth of a gram per mile, comprise the city and highway fuel economy and CO 2 emission values for that configuration. Note that the appropriate vehicle-specific CO 2 values for fuel economy labels based on 5-cycle testing with E10 test fuel are adjusted as described in § 600.114-12. (2) If more than one set of 5-cycle city and highway fuel economy and CO 2 emission values are accepted for a vehicle configuration: (i) All data shall be grouped according to the subconfiguration for which the data were generated using sales projections supplied in accordance with § 600.209-12(a)(3). (ii) Within each subconfiguration of data, all fuel economy values are harmonically averaged and rounded to the nearest 0.0001 of a mile per gallon in order to determine 5-cycle city and highway fuel economy values for each subconfiguration at which the vehicle configuration was tested, and all CO 2 emissions values are arithmetically averaged and rounded to the nearest tenth of gram per mile to determine 5-cycle city and highway CO 2 emission values for each subconfiguration at which the vehicle configuration was tested. Note that the appropriate vehicle-specific CO 2 values for fuel economy labels based on 5-cycle testing with E10 test fuel are adjusted as described in § 600.114-12. (iii) All 5-cycle city fuel economy values and all 5-cycle highway fuel economy values calculated in paragraph (a)(2)(ii) of this section are (separately for city and highway) averaged in proportion to the sales fraction (rounded to the nearest 0.0001) within the vehicle configuration (as provided to the Administrator by the manufacturer) of vehicles of each tested subconfiguration. The resultant values, rounded to the nearest 0.0001 mile per gallon, are the 5-cycle city and 5-cycle highway fuel economy values for the vehicle configuration. (iv) All 5-cycle city CO 2 emission values and all 5-cycle highway CO 2 emission values calculated in paragraph (a)(2)(ii) of this section are (separately for city and highway) averaged in proportion to the sales fraction (rounded to the nearest 0.0001) within the vehicle configuration (as provided to the Administrator by the manufacturer) of vehicles of each tested subconfiguration. The resultant values, rounded to the nearest 0.1 grams per mile, are the 5-cycle city and 5-cycle highway CO 2 emission values for the vehicle configuration. (3) [Reserved] (4) For alcohol dual fuel automobiles and natural gas dual fuel automobiles, the procedures of paragraphs (a)(1) and (2) of this section shall be used to calculate two separate sets of 5-cycle city and highway fuel economy and CO 2 emission values for each configuration. (i) Calculate the 5-cycle city and highway fuel economy and CO 2 emission values from the tests performed using gasoline or diesel test fuel. (ii) Calculate the 5-cycle city and highway fuel economy and CO 2 emission values from the tests performed using alcohol or natural gas test fuel, if 5-cycle testing has been performed. Otherwise, the procedure in § 600.210-12(a)(3) or (b)(3) applies. (b) If only one equivalent petroleum-based fuel economy value exists for an electric configuration, that value, rounded to the nearest tenth of a mile per gallon, will comprise the petroleum-based 5-cycle fuel economy for that configuration. (c) If more than one equivalent petroleum-based 5-cycle fuel economy value exists for an electric vehicle configuration, all values for that vehicle configuration are harmonically averaged and rounded to the nearest 0.0001 mile per gallon for that configuration." 40:40:32.0.1.4.44.3.13.3,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,C,Subpart C—Procedures for Calculating Fuel Economy and Carbon-Related Exhaust Emission Values,,"§ 600.208-12 Calculation of FTP-based and HFET-based fuel economy, CO",EPA,,,"[76 FR 39552, July 6, 2011, as amended at 81 FR 74002, Oct. 25, 2016; 89 FR 28208, Apr. 18, 2024]","(a) Fuel economy, CO 2 emissions, and carbon-related exhaust emissions for a base level are calculated from vehicle configuration fuel economy, CO 2 emissions, and carbon-related exhaust emissions as determined in § 600.206-12(a), (b), or (c) as applicable, for low-altitude tests. (1) If the Administrator determines that automobiles intended for sale in the State of California and in section 177 states are likely to exhibit significant differences in fuel economy, CO 2 emissions, and carbon-related exhaust emissions from those intended for sale in other states, she will calculate fuel economy, CO 2 emissions, and carbon-related exhaust emissions for each base level for vehicles intended for sale in California and in section 177 states and for each base level for vehicles intended for sale in the rest of the states. (2) In order to highlight the fuel efficiency, CO 2 emissions, and carbon-related exhaust emissions of certain designs otherwise included within a model type, a manufacturer may wish to subdivide a model type into one or more additional model types. This is accomplished by separating subconfigurations from an existing base level and placing them into a new base level. The new base level is identical to the existing base level except that it shall be considered, for the purposes of this paragraph, as containing a new basic engine. The manufacturer will be permitted to designate such new basic engines and base level(s) if: (i) Each additional model type resulting from division of another model type has a unique car line name and that name appears on the label and on the vehicle bearing that label; (ii) The subconfigurations included in the new base levels are not included in any other base level which differs only by basic engine ( i.e., they are not included in the calculation of the original base level fuel economy values); and (iii) All subconfigurations within the new base level are represented by test data in accordance with § 600.010(c)(1)(iii). (3) The manufacturer shall supply total model year sales projections for each car line/vehicle subconfiguration combination. (i) Sales projections must be supplied separately for each car line-vehicle subconfiguration intended for sale in California and each car line/vehicle subconfiguration intended for sale in the rest of the states if required by the Administrator under paragraph (a)(1) of this section. (ii) Manufacturers shall update sales projections at the time any model type value is calculated for a label value. (iii) The provisions of paragraph (a)(3) of this section may be satisfied by providing an amended application for certification, as described in § 86.1844 of this chapter. (4) Vehicle configuration fuel economy, CO 2 emissions, and carbon-related exhaust emissions, as determined in § 600.206-12(a), (b) or (c), as applicable, are grouped according to base level. (i) If only one vehicle configuration within a base level has been tested, the fuel economy, CO 2 emissions, and carbon-related exhaust emissions from that vehicle configuration will constitute the fuel economy, CO 2 emissions, and carbon-related exhaust emissions for that base level. Note that the appropriate vehicle subconfiguration CO 2 values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.206-12(a)(2)(iii); those values are used to calculate the base level CO 2 values in this paragraph (a)(4)(i). (ii) If more than one vehicle configuration within a base level has been tested, the vehicle configuration fuel economy values are harmonically averaged in proportion to the respective sales fraction (rounded to the nearest 0.0001) of each vehicle configuration and the resultant fuel economy value rounded to the nearest 0.0001 mile per gallon; and the vehicle configuration CO 2 emissions and carbon-related exhaust emissions are arithmetically averaged in proportion to the respective sales fraction (rounded to the nearest 0.0001) of each vehicle configuration and the resultant carbon-related exhaust emission value rounded to the nearest tenth of a gram per mile. Note that the appropriate vehicle subconfiguration CO 2 values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.206-12(a)(2)(iii); those values are used to calculate the base level CO 2 values in this paragraph (a)(4)(ii). (5) The procedure specified in paragraph (a)(1) through (4) of this section will be repeated for each base level, thus establishing city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emissions for each base level. (6) [Reserved] (7) For alcohol dual fuel automobiles and natural gas dual fuel automobiles, the procedures of paragraphs (a)(1) through (6) of this section shall be used to calculate two separate sets of city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emissions for each base level. (i) Calculate the city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emissions from the tests performed using gasoline or diesel test fuel. (ii) Calculate the city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emissions from the tests performed using alcohol or natural gas test fuel. (b) For each model type, as determined by the Administrator, a city, highway, and combined fuel economy value, CO 2 emission value, and a carbon-related exhaust emission value will be calculated by using the projected sales and values for fuel economy, CO 2 emissions, and carbon-related exhaust emissions for each base level within the model type. Separate model type calculations will be done based on the vehicle configuration fuel economy, CO 2 emissions, and carbon-related exhaust emissions as determined in § 600.206-12(a), (b) or (c), as applicable. (1) If the Administrator determines that automobiles intended for sale in the State of California and in section 177 states are likely to exhibit significant differences in fuel economy, CO 2 emissions, and carbon-related exhaust emissions from those intended for sale in other states, he or she will calculate values for fuel economy, CO 2 emissions, and carbon-related exhaust emissions for each model type for vehicles intended for sale in California and in section 177 states and for each model type for vehicles intended for sale in the rest of the states. (2) The sales fraction for each base level is calculated by dividing the projected sales of the base level within the model type by the projected sales of the model type and rounding the quotient to the nearest 0.0001. (3)(i) The FTP-based city fuel economy values of the model type (calculated to the nearest 0.0001 mpg) are determined by dividing one by a sum of terms, each of which corresponds to a base level and which is a fraction determined by dividing: (A) The sales fraction of a base level; by (B) The FTP-based city fuel economy value for the respective base level. (ii) The FTP-based city carbon-related exhaust emission value of the model type (calculated to the nearest gram per mile) are determined by a sum of terms, each of which corresponds to a base level and which is a product determined by multiplying: (A) The sales fraction of a base level; by (B) The FTP-based city carbon-related exhaust emission value for the respective base level. (iii) The FTP-based city CO 2 emissions of the model type (calculated to the nearest gram per mile) are determined by a sum of terms, each of which corresponds to a base level and which is a product determined by multiplying: (A) The sales fraction of a base level; by (B) The FTP-based city CO 2 emissions for the respective base level. (C) Note that the appropriate base level CO 2 values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in paragraph (a)(4)(i) and (ii) of this section; those values are used to calculate the model type FTP-based city CO 2 values in this paragraph (b)(3)(iii). (4) The procedure specified in paragraph (b)(3) of this section is repeated in an analogous manner to determine the highway and combined fuel economy, CO 2 emissions, and carbon-related exhaust emissions for the model type. (5) For alcohol dual fuel automobiles and natural gas dual fuel automobiles, the procedures of paragraphs (b)(1) through (4) of this section shall be used to calculate two separate sets of city, highway, and combined fuel economy values and two separate sets of city, highway, and combined CO 2 and carbon-related exhaust emission values for each model type. (i) Calculate the city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emission values from the tests performed using gasoline or diesel test fuel. (ii) Calculate the city, highway, and combined fuel economy, CO 2 emissions, and carbon-related exhaust emission values from the tests performed using alcohol or natural gas test fuel." 40:40:32.0.1.4.44.3.13.4,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,C,Subpart C—Procedures for Calculating Fuel Economy and Carbon-Related Exhaust Emission Values,,§ 600.209-12 Calculation of vehicle-specific 5-cycle fuel economy and CO,EPA,,,"[76 FR 39553, July 6, 2011, as amended at 89 FR 28209, Apr. 18, 2024]","(a) Base level. 5-cycle fuel economy and CO 2 emission values for a base level are calculated from vehicle configuration 5-cycle fuel economy and CO 2 emission values as determined in § 600.207 for low-altitude tests. Note that the appropriate vehicle-specific CO 2 values for fuel economy labels based on 5-cycle testing with E10 test fuel are adjusted as described in § 600.114-12. (1) If the Administrator determines that automobiles intended for sale in the State of California are likely to exhibit significant differences in fuel economy and CO 2 emissions from those intended for sale in other states, he will calculate fuel economy and CO 2 emission values for each base level for vehicles intended for sale in California and for each base level for vehicles intended for sale in the rest of the states. (2) In order to highlight the fuel efficiency and CO 2 emissions of certain designs otherwise included within a model type, a manufacturer may wish to subdivide a model type into one or more additional model types. This is accomplished by separating subconfigurations from an existing base level and placing them into a new base level. The new base level is identical to the existing base level except that it shall be considered, for the purposes of this paragraph, as containing a new basic engine. The manufacturer will be permitted to designate such new basic engines and base level(s) if: (i) Each additional model type resulting from division of another model type has a unique car line name and that name appears on the label and on the vehicle bearing that label; (ii) The subconfigurations included in the new base levels are not included in any other base level which differs only by basic engine ( i.e., they are not included in the calculation of the original base level fuel economy values); and (iii) All subconfigurations within the new base level are represented by test data in accordance with § 600.010(c)(i)(ii). (3) The manufacturer shall supply total model year sales projections for each car line/vehicle subconfiguration combination. (i) Sales projections must be supplied separately for each car line-vehicle subconfiguration intended for sale in California and each car line/vehicle subconfiguration intended for sale in the rest of the states if required by the Administrator under paragraph (a)(1) of this section. (ii) Manufacturers shall update sales projections at the time any model type value is calculated for a label value. (iii) The provisions of this paragraph (a)(3) may be satisfied by providing an amended application for certification, as described in § 86.1844 of this chapter. (4) 5-cycle vehicle configuration fuel economy and CO 2 emission values, as determined in § 600.207-12(a), (b), or (c), as applicable, are grouped according to base level. (i) If only one vehicle configuration within a base level has been tested, the fuel economy and CO 2 emission values from that vehicle configuration constitute the fuel economy and CO 2 emission values for that base level. (ii) If more than one vehicle configuration within a base level has been tested, the vehicle configuration fuel economy values are harmonically averaged in proportion to the respective sales fraction (rounded to the nearest 0.0001) of each vehicle configuration and the resultant fuel economy value rounded to the nearest 0.0001 mile per gallon. (iii) If more than one vehicle configuration within a base level has been tested, the vehicle configuration CO 2 emission values are arithmetically averaged in proportion to the respective sales fraction (rounded to the nearest 0.0001) of each vehicle configuration and the resultant CO 2 emission value rounded to the nearest 0.1 gram per mile. (5) The procedure specified in § 600.209-12(a) will be repeated for each base level, thus establishing city and highway fuel economy and CO 2 emission values for each base level. (6) [Reserved] (7) For alcohol dual fuel automobiles and natural gas dual fuel automobiles, the procedures of paragraphs (a)(1) through (6) of this section shall be used to calculate two separate sets of city, highway, and combined fuel economy and CO 2 emission values for each base level. (i) Calculate the city and highway fuel economy and CO 2 emission values from the tests performed using gasoline or diesel test fuel. (ii) If 5-cycle testing was performed on the alcohol or natural gas test fuel, calculate the city and highway fuel economy and CO 2 emission values from the tests performed using alcohol or natural gas test fuel. (b) Model type. For each model type, as determined by the Administrator, city and highway fuel economy and CO 2 emissions values will be calculated by using the projected sales and fuel economy and CO 2 emission values for each base level within the model type. Separate model type calculations will be done based on the vehicle configuration fuel economy and CO 2 emission values as determined in § 600.207-12, as applicable. Note that the appropriate vehicle-specific CO 2 values for fuel economy labels based on 5-cycle testing with E10 test fuel are adjusted as described in § 600.114-12. (1) If the Administrator determines that automobiles intended for sale in the State of California are likely to exhibit significant differences in fuel economy and CO 2 emissions from those intended for sale in other states, he will calculate fuel economy and CO 2 emission values for each model type for vehicles intended for sale in California and for each model type for vehicles intended for sale in the rest of the states. (2) The sales fraction for each base level is calculated by dividing the projected sales of the base level within the model type by the projected sales of the model type and rounding the quotient to the nearest 0.0001. (3)(i) The 5-cycle city fuel economy values of the model type (calculated to the nearest 0.0001 mpg) are determined by dividing one by a sum of terms, each of which corresponds to a base level and which is a fraction determined by dividing: (A) The sales fraction of a base level; by (B) The 5-cycle city fuel economy value for the respective base level. (ii) The 5-cycle city CO 2 emissions of the model type (calculated to the nearest tenth of a gram per mile) are determined by a sum of terms, each of which corresponds to a base level and which is a product determined by multiplying: (A) The sales fraction of a base level; by (B) The 5-cycle city CO 2 emissions for the respective base level. (4) The procedure specified in paragraph (b)(3) of this section is repeated in an analogous manner to determine the highway and combined fuel economy and CO 2 emission values for the model type. (5) For alcohol dual fuel automobiles and natural gas dual fuel automobiles the procedures of paragraphs (b)(1) through (4) of this section shall be used to calculate two separate sets of city and highway fuel economy and CO 2 emission values for each model type. (i) Calculate the city and highway fuel economy and CO 2 emission values from the tests performed using gasoline or diesel test fuel. (ii) Calculate the city, highway, and combined fuel economy and CO 2 emission values from the tests performed using alcohol or natural gas test fuel, if 5-cycle testing was performed on the alcohol or natural gas test fuel. Otherwise, the procedure in § 600.210-12(a)(3) or (b)(3) applies." 40:40:32.0.1.4.44.3.13.5,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,C,Subpart C—Procedures for Calculating Fuel Economy and Carbon-Related Exhaust Emission Values,,§ 600.210-12 Calculation of fuel economy and CO,EPA,,,"[76 FR 39554, July 6, 2011, as amended at 76 FR 57380, Sept. 15, 2011; 77 FR 63183, Oct. 15, 2012; 81 FR 74002, Oct. 25, 2016; 88 FR 4483, Jan. 24, 2023; 89 FR 28209, Apr. 18, 2024]","(a) General labels. Except as specified in paragraphs (d) and (e) of this section, fuel economy and CO 2 emissions for general labels may be determined by one of two methods. The first is based on vehicle-specific model-type 5-cycle data as determined in § 600.209-12(b). This method is available for all vehicles and is required for vehicles that do not qualify for the second method as described in § 600.115 (other than electric vehicles). The second method, the derived 5-cycle method, determines fuel economy and CO 2 emissions values from the FTP and HFET tests using equations that are derived from vehicle-specific 5-cycle model type data, as determined in paragraph (a)(2) of this section. Manufacturers may voluntarily lower fuel economy (MPG) values and raise CO 2 values if they determine that the label values from any method are not representative of the in-use fuel economy and CO 2 emissions for that model type, but only if the manufacturer changes both the MPG values and the CO 2 value and revises any other affected label value accordingly for a model type (including but not limited to the fuel economy 1-10 rating, greenhouse gas 1-10 rating, annual fuel cost, 5-year fuel cost information). Similarly, for any electric vehicles and plug-in hybrid electric vehicles, manufacturers may voluntarily lower the fuel economy (MPGe) and raise the energy consumption (kW-hr/100 mile) values if they determine that the label values are not representative of the in-use fuel economy, energy consumption, and CO 2 emissions for that model type, but only if the manufacturer changes both the MPGe and the energy consumption value and revises any other affected label value accordingly for a model type. Manufacturers may voluntarily lower the value for electric driving range if they determine that the label values are not representative of the in-use electric driving range. (1) Vehicle-specific 5-cycle labels. The city and highway model type fuel economy determined in § 600.209-12(b), rounded to the nearest mpg, and the city and highway model type CO 2 emissions determined in § 600.209-12(b), rounded to the nearest gram per mile, comprise the fuel economy and CO 2 emission values for general fuel economy labels, or, alternatively; (2) Derived 5-cycle labels. Derived 5-cycle city and highway label values are determined according to the following method: (i)(A) For each model type, determine the derived five-cycle city fuel economy using the following equation and coefficients determined by the Administrator: Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. MT FTP FE = the model type FTP-based city fuel economy determined under § 600.208-12(b), rounded to the nearest 0.0001 mpg. Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. MT FTP FE = the model type FTP-based city fuel economy determined under § 600.208-12(b), rounded to the nearest 0.0001 mpg. (B) For each model type, determine the derived five-cycle city CO 2 emissions using the following equation and coefficients determined by the Administrator: Derived 5-cycle City CO 2 = City Intercept · A + City Slope · MT FTP CO 2 Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. A = 8,887 for gasoline-fueled vehicles, 10,180 for diesel-fueled vehicles, or an appropriate value specified by the Administrator for other fuels. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. MT FTP CO 2 = the model type FTP-based city CO 2 emissions determined under § 600.208-12(b), rounded to the nearest 0.1 grams per mile. Note that the appropriate MT FTP CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.208-12(b)(3)(iii). Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. A = 8,887 for gasoline-fueled vehicles, 10,180 for diesel-fueled vehicles, or an appropriate value specified by the Administrator for other fuels. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. MT FTP CO 2 = the model type FTP-based city CO 2 emissions determined under § 600.208-12(b), rounded to the nearest 0.1 grams per mile. Note that the appropriate MT FTP CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.208-12(b)(3)(iii). (ii)(A) For each model type, determine the derived five-cycle highway fuel economy using the equation below and coefficients determined by the Administrator: Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. MT HFET FE = the model type highway fuel economy determined under § 600.208-12(b), rounded to the nearest 0.0001 mpg. Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. MT HFET FE = the model type highway fuel economy determined under § 600.208-12(b), rounded to the nearest 0.0001 mpg. (B) For each model type, determine the derived five-cycle highway CO 2 emissions using the equation below and coefficients determined by the Administrator: Derived 5-cycle Highway CO 2 = Highway Intercept · A + Highway Slope · MT HFET CO 2 Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. A = 8,887 for gasoline-fueled vehicles, 10,180 for diesel-fueled vehicles, or an appropriate value specified by the Administrator for other fuels. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. MT HFET CO 2 = the model type highway CO 2 emissions determined under § 600.208-12(b), rounded to the nearest 0.1 grams per mile. Note that the appropriate the MT HFET CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.208-12(b)(3)(iii) and (b)(4). Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. A = 8,887 for gasoline-fueled vehicles, 10,180 for diesel-fueled vehicles, or an appropriate value specified by the Administrator for other fuels. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. MT HFET CO 2 = the model type highway CO 2 emissions determined under § 600.208-12(b), rounded to the nearest 0.1 grams per mile. Note that the appropriate the MT HFET CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.208-12(b)(3)(iii) and (b)(4). (iii) Unless and until superseded by written guidance from the Administrator, the following intercepts and slopes shall be used in the equations in paragraphs (a)(2)(i) and (ii) of this section: City Intercept = 0.004091. City Slope = 1.1601. Highway Intercept = 0.003191. Highway Slope = 1.2945. (iv) The Administrator will periodically update the slopes and intercepts through guidance and will determine the model year that the new coefficients must take effect. The Administrator will issue guidance no later than six months prior to the earliest starting date of the effective model year (e.g., for 2011 models, the earliest start of the model year is January 2, 2010, so guidance would be issued by July 1, 2009.) Until otherwise instructed by written guidance from the Administrator, manufacturers must use the coefficients that are currently in effect. (3) General alternate fuel economy and CO 2 emissions label values for dual fuel vehicles. (i)(A) City and Highway fuel economy label values for dual fuel alcohol-based and natural gas vehicles when using the alternate fuel are separately determined by the following calculation: Where: FE alt = The unrounded FTP-based model-type city or HFET-based model-type highway fuel economy from the alternate fuel, as determined in § 600.208-12(b)(5)(ii). 5cycle FE gas = The unrounded vehicle-specific or derived 5-cycle model-type city or highway fuel economy, as determined in paragraph (a)(1) or (2) of this section. FE gas = The unrounded FTP-based city or HFET-based model type highway fuel economy from gasoline (or diesel), as determined in § 600.208-12(b)(5)(i). Where: FE alt = The unrounded FTP-based model-type city or HFET-based model-type highway fuel economy from the alternate fuel, as determined in § 600.208-12(b)(5)(ii). 5cycle FE gas = The unrounded vehicle-specific or derived 5-cycle model-type city or highway fuel economy, as determined in paragraph (a)(1) or (2) of this section. FE gas = The unrounded FTP-based city or HFET-based model type highway fuel economy from gasoline (or diesel), as determined in § 600.208-12(b)(5)(i). The result, rounded to the nearest whole number, is the alternate fuel label value for dual fuel vehicles. (B) City and Highway CO 2 label values for dual fuel alcohol-based and natural gas vehicles when using the alternate fuel are separately determined by the following calculation: Where: CO2 alt = The unrounded FTP-based model-type city or HFET-based model-type CO 2 emissions value from the alternate fuel, as determined in § 600.208-12(b)(5)(ii). 5cycle CO2 gas = The unrounded vehicle-specific or derived 5-cycle model-type city or highway CO 2 emissions value, as determined in paragraph (a)(1) or (2) of this section. CO2 gas = The unrounded FTP-based city or HFET-based model type highway CO 2 emissions value from gasoline (or diesel), as determined in § 600.208-12(b)(5)(i). The result, rounded to the nearest whole number, is the alternate fuel CO 2 emissions label value for dual fuel vehicles. Where: CO2 alt = The unrounded FTP-based model-type city or HFET-based model-type CO 2 emissions value from the alternate fuel, as determined in § 600.208-12(b)(5)(ii). 5cycle CO2 gas = The unrounded vehicle-specific or derived 5-cycle model-type city or highway CO 2 emissions value, as determined in paragraph (a)(1) or (2) of this section. CO2 gas = The unrounded FTP-based city or HFET-based model type highway CO 2 emissions value from gasoline (or diesel), as determined in § 600.208-12(b)(5)(i). The result, rounded to the nearest whole number, is the alternate fuel CO 2 emissions label value for dual fuel vehicles. (ii) Optionally, if complete 5-cycle testing has been performed using the alternate fuel, the manufacturer may choose to use the alternate fuel label city or highway fuel economy and CO 2 emission values determined in § 600.209-12(b)(5)(ii), rounded to the nearest whole number. (4) General alternate fuel economy and CO 2 emissions label values for electric vehicles. Determine FTP-based city and HFET-based highway fuel economy label values for electric vehicles as described in § 600.116. Convert W-hour/mile results to miles per kW-hr and miles per gasoline gallon equivalent. CO 2 label information is based on tailpipe emissions only, so CO 2 emissions from electric vehicles are assumed to be zero. (5) General alternate fuel economy and CO 2 emissions label values for fuel cell vehicles. Determine FTP-based city and HFET-based highway fuel economy label values for fuel cell vehicles using procedures specified by the Administrator. Convert kilograms of hydrogen/mile results to miles per kilogram of hydrogen and miles per gasoline gallon equivalent. CO 2 label information is based on tailpipe emissions only, so CO 2 emissions from fuel cell vehicles are assumed to be zero. (b) Specific labels. Except as specified in paragraphs (d) and (e) of this section, fuel economy and CO 2 emissions for specific labels may be determined by one of two methods. The first is based on vehicle-specific configuration 5-cycle data as determined in § 600.207. This method is available for all vehicles and is required for vehicles that do not qualify for the second method as described in § 600.115 (other than electric vehicles). The second method, the derived 5-cycle method, determines fuel economy and CO 2 emissions values from the FTP and HFET tests using equations that are derived from vehicle-specific 5-cycle configuration data, as determined in paragraph (b)(2) of this section. Manufacturers may voluntarily lower fuel economy values and raise CO 2 values if they determine that the label values from either method are not representative of the fuel economy or CO 2 emissions for that model type. (1) Vehicle-specific 5-cycle labels. The city and highway configuration fuel economy determined in § 600.207, rounded to the nearest mpg, and the city and highway configuration CO 2 emissions determined in § 600.207, rounded to the nearest gram per mile, comprise the fuel economy and CO 2 emission values for specific fuel economy labels, or, alternatively; (2) Derived 5-cycle labels. Specific city and highway label values from derived 5-cycle are determined according to the following method: (i)(A) Determine the derived five-cycle city fuel economy of the configuration using the equation below and coefficients determined by the Administrator: Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. Config FTP FE = the configuration FTP-based city fuel economy determined under § 600.206, rounded to the nearest 0.0001 mpg. Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. Config FTP FE = the configuration FTP-based city fuel economy determined under § 600.206, rounded to the nearest 0.0001 mpg. (B) Determine the derived five-cycle city CO 2 emissions of the configuration using the equation below and coefficients determined by the Administrator: Derived 5-cycle City CO 2 = City Intercept + City Slope ·Config FTP CO 2 Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. Config FTP CO 2 = the configuration FTP-based city CO 2 emissions determined under § 600.206, rounded to the nearest 0.1 grams per mile. Note that the appropriate Config FTP CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.206-12(a)(2)(iii). Where: City Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. City Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle city fuel economy data. Config FTP CO 2 = the configuration FTP-based city CO 2 emissions determined under § 600.206, rounded to the nearest 0.1 grams per mile. Note that the appropriate Config FTP CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.206-12(a)(2)(iii). (ii)(A) Determine the derived five-cycle highway fuel economy of the configuration using the equation below and coefficients determined by the Administrator: Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Config HFET FE = the configuration highway fuel economy determined under § 600.206, rounded to the nearest tenth. Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Config HFET FE = the configuration highway fuel economy determined under § 600.206, rounded to the nearest tenth. (B) Determine the derived five-cycle highway CO 2 emissions of the configuration using the equation below and coefficients determined by the Administrator: Derived 5-cycle city Highway CO 2 = Highway Intercept + Highway Slope · Config HFET CO 2 Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Config HFET CO 2 = the configuration highway fuel economy determined under § 600.206, rounded to the nearest tenth. Note that the appropriate Config HFET CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.206-12(a)(2)(iii). Where: Highway Intercept = Intercept determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Highway Slope = Slope determined by the Administrator based on historic vehicle-specific 5-cycle highway fuel economy data. Config HFET CO 2 = the configuration highway fuel economy determined under § 600.206, rounded to the nearest tenth. Note that the appropriate Config HFET CO 2 input values for fuel economy labels based on testing with E10 test fuel are adjusted as referenced in § 600.206-12(a)(2)(iii). (iii) The slopes and intercepts of paragraph (a)(2)(iii) of this section apply. (3) Specific alternate fuel economy and CO 2 emissions label values for dual fuel vehicles. (i)(A) Specific city and highway fuel economy label values for dual fuel alcohol-based and natural gas vehicles when using the alternate fuel are separately determined by the following calculation: Where: FE alt = The unrounded FTP-based configuration city or HFET-based configuration highway fuel economy from the alternate fuel, as determined in § 600.206. 5cycle FE gas = The unrounded vehicle-specific or derived 5-cycle configuration city or highway fuel economy as determined in paragraph (b)(1) or (2) of this section. FE gas = The unrounded FTP-based city or HFET-based configuration highway fuel economy from gasoline, as determined in § 600.206. The result, rounded to the nearest whole number, is the alternate fuel label value for dual fuel vehicles. Where: FE alt = The unrounded FTP-based configuration city or HFET-based configuration highway fuel economy from the alternate fuel, as determined in § 600.206. 5cycle FE gas = The unrounded vehicle-specific or derived 5-cycle configuration city or highway fuel economy as determined in paragraph (b)(1) or (2) of this section. FE gas = The unrounded FTP-based city or HFET-based configuration highway fuel economy from gasoline, as determined in § 600.206. The result, rounded to the nearest whole number, is the alternate fuel label value for dual fuel vehicles. (B) Specific city and highway CO 2 emission label values for dual fuel alcohol-based and natural gas vehicles when using the alternate fuel are separately determined by the following calculation: Where: CO2 alt = The unrounded FTP-based configuration city or HFET-based configuration highway CO 2 emissions value from the alternate fuel, as determined in § 600.206. 5cycle CO2 gas = The unrounded vehicle-specific or derived 5-cycle configuration city or highway CO 2 emissions value as determined in paragraph (b)(1) or (b)(2) of this section. CO2 gas = The unrounded FTP-based city or HFET-based configuration highway CO 2 emissions value from gasoline, as determined in § 600.206. The result, rounded to the nearest whole number, is the alternate fuel CO 2 emissions label value for dual fuel vehicles. Where: CO2 alt = The unrounded FTP-based configuration city or HFET-based configuration highway CO 2 emissions value from the alternate fuel, as determined in § 600.206. 5cycle CO2 gas = The unrounded vehicle-specific or derived 5-cycle configuration city or highway CO 2 emissions value as determined in paragraph (b)(1) or (b)(2) of this section. CO2 gas = The unrounded FTP-based city or HFET-based configuration highway CO 2 emissions value from gasoline, as determined in § 600.206. The result, rounded to the nearest whole number, is the alternate fuel CO 2 emissions label value for dual fuel vehicles. (ii) Optionally, if complete 5-cycle testing has been performed using the alternate fuel, the manufacturer may choose to use the alternate fuel label city or highway fuel economy and CO 2 emission values determined in § 600.207-12(a)(4)(ii), rounded to the nearest whole number. (4) Specific alternate fuel economy and CO 2 emissions label values for electric vehicles. Determine FTP-based city and HFET-based highway fuel economy label values for electric vehicles as described in § 600.116. Determine these values by running the appropriate repeat test cycles. Convert W-hour/mile results to miles per kW-hr and miles per gasoline gallon equivalent. CO 2 label information is based on tailpipe emissions only, so CO 2 emissions from electric vehicles are assumed to be zero. (5) Specific alternate fuel economy and CO 2 emissions label values for fuel cell vehicles. Determine FTP-based city and HFET-based highway fuel economy label values for fuel cell vehicles using procedures specified by the Administrator. Convert kilograms of hydrogen/mile results to miles per kilogram of hydrogen and miles per gasoline gallon equivalent. CO 2 label information is based on tailpipe emissions only, so CO 2 emissions from fuel cell vehicles are assumed to be zero. (c) Calculating combined fuel economy. (1) For the purposes of calculating the combined fuel economy for a model type, to be used in displaying on the label and for determining annual fuel costs under subpart D of this part, the manufacturer shall use one of the following procedures: (i) For gasoline-fueled, diesel-fueled, alcohol-fueled, and natural gas-fueled automobiles, and for dual fuel automobiles that can operate on gasoline or diesel fuel, harmonically average the unrounded city and highway fuel economy values, determined in paragraphs (a)(1) or (2) of this section and (b)(1) or (2) of this section, weighted 0.55 and 0.45 respectively. Round the result to the nearest whole mpg. (An example of this calculation procedure appears in Appendix II of this part). (ii) For alcohol dual fuel and natural gas dual fuel automobiles operated on the alternate fuel, harmonically average the unrounded city and highway values from the tests performed using the alternative fuel as determined in paragraphs (a)(3) and (b)(3) of this section, weighted 0.55 and 0.45 respectively. Round the result to the nearest whole mpg. (iii) For electric vehicles, calculate the combined fuel economy, in miles per kW-hr and miles per gasoline gallon equivalent, by harmonically averaging the unrounded city and highway values, weighted 0.55 and 0.45 respectively. Round miles per kW-hr to the nearest 0.001 and round miles per gasoline gallon equivalent to the nearest whole number. (iv) For plug-in hybrid electric vehicles, calculate a combined fuel economy value, in miles per gasoline gallon equivalent as follows: (A) Determine city and highway fuel economy values for vehicle operation after the battery has been fully discharged (“gas only operation” or “charge-sustaining mode”) as described in paragraphs (a) and (b) of this section. (B) Determine city and highway fuel economy values for vehicle operation starting with a full battery charge (“all-electric operation” or “gas plus electric operation”, as appropriate, or “charge-depleting mode”) as described in § 600.116. For battery energy, convert W-hour/mile results to miles per gasoline gallon equivalent or miles per diesel gallon equivalent, as applicable. Note that you must also express battery-based fuel economy values in miles per kW-hr for calculating annual fuel cost as described in § 600.311. (C) Calculate a composite city fuel economy value and a composite highway fuel economy value by combining the separate results for battery and engine operation using the procedures described in § 600.116). Apply the derived 5-cycle adjustment to these composite values. Use these values to calculate the vehicle's combined fuel economy as described in paragraph (c)(1)(i) of this section. (v) For fuel cell vehicles, calculate the combined fuel economy, in miles per kilogram and miles per gasoline gallon equivalent, by harmonically averaging the unrounded city and highway values, weighted 0.55 and 0.45 respectively. Round miles per kilogram to the nearest whole number and round miles per gasoline gallon equivalent to the nearest whole number. (2) For the purposes of calculating the combined CO 2 emissions value for a model type, to be used in displaying on the label under subpart D of this part, the manufacturer shall: (i) For gasoline-fueled, diesel-fueled, alcohol-fueled, and natural gas-fueled automobiles, and for dual fuel automobiles that can operate on gasoline or diesel fuel, arithmetically average the unrounded city and highway values, determined in paragraphs (a)(1) or (2) of this section and (b)(1) or (2) of this section, weighted 0.55 and 0.45 respectively, and round to the nearest whole gram per mile; or (ii) For alcohol dual fuel and natural gas dual fuel automobiles operated on the alternate fuel, arithmetically average the unrounded city and highway CO 2 emission values from the tests performed using the alternative fuel as determined in paragraphs (a)(3) and (b)(3) of this section, weighted 0.55 and 0.45 respectively, and round to the nearest whole gram per mile. (iii) CO 2 label information is based on tailpipe emissions only, so CO 2 emissions from electric vehicles and fuel cell vehicles are assumed to be zero. (iv) For plug-in hybrid electric vehicles, calculate combined CO 2 emissions as follows: (A) Determine city and highway CO 2 emission rates for vehicle operation after the battery has been fully discharged (“gas only operation” or “charge-sustaining mode”) as described in paragraphs (a) and (b) of this section. (B) Determine city and highway CO 2 emission rates for vehicle operation starting with a full battery charge (“all-electric operation” or “gas plus electric operation”, as appropriate, or “charge-depleting mode”) as described in § 600.116. Note that CO 2 label information is based on tailpipe emissions only, so CO 2 emissions from electricity are assumed to be zero. (C) Calculate a composite city CO 2 emission rate and a composite highway CO 2 emission rate by combining the separate results for battery and engine operation using the procedures described in § 600.116. Use these values to calculate the vehicle's combined CO 2 emissions as described in paragraph (c)(2)(i) of this section. (d) Calculating combined fuel economy, CO 2 emissions, and driving range. (1) If the criteria in § 600.115-11(a) are met for a model type, both the city and highway fuel economy and CO 2 emissions values must be determined using the vehicle-specific 5-cycle method. If the criteria in § 600.115-11(b) are met for a model type, the city fuel economy and CO 2 emissions values may be determined using either method, but the highway fuel economy and CO 2 emissions values must be determined using the vehicle-specific 5-cycle method (or modified 5-cycle method as allowed under § 600.114-12(b)(2)). (2) If the criteria in § 600.115 are not met for a model type, the city and highway fuel economy and CO 2 emission label values must be determined by using the same method, either the derived 5-cycle or vehicle-specific 5-cycle. (3) Manufacturers may use one of the following methods to determine 5-cycle values for fuel economy, CO 2 emissions, and driving range for electric vehicles: (i) Generate 5-cycle data as described in paragraph (a)(1) of this section using the procedures of SAE J1634 (incorporated by reference in § 600.011) with amendments and revisions as described in § 600.116-12(a). (ii) Multiply 2-cycle fuel economy values and driving range by 0.7 and divide 2-cycle CO 2 emission values by 0.7. (iii) Manufacturers may ask the Administrator to approve adjustment factors for deriving 5-cycle fuel economy results from 2-cycle test data based on operating data from their in-use vehicles. Such data should be collected from multiple vehicles with different drivers over a range of representative driving routes and conditions. The Administrator may approve such an adjustment factor for any of the manufacturer's vehicle models that are properly represented by the collected data. (e) Fuel economy values and other information for advanced technology vehicles. (1) The Administrator may prescribe an alternative method of determining the city and highway model type fuel economy and CO 2 emission values for general, unique or specific fuel economy labels other than those set forth in this subpart C for advanced technology vehicles including, but not limited to fuel cell vehicles, hybrid electric vehicles using hydraulic energy storage, and vehicles equipped with hydrogen internal combustion engines. (2) For advanced technology vehicles, the Administrator may prescribe special methods for determining information other than fuel economy that is required to be displayed on fuel economy labels as specified in § 600.302-12(e). (f) Sample calculations. An example of the calculation required in this subpart is in Appendix III of this part." 40:40:32.0.1.4.44.4.13.1,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.301 Labeling requirements.,EPA,,,"[76 FR 39558, July 6, 2011]","(a) Prior to being offered for sale, each manufacturer shall affix or cause to be affixed and each dealer shall maintain or cause to be maintained on each automobile: (1) A general fuel economy label (initial, or updated as required in § 600.314) as described in § 600.302 or: (2) A specific label, for those automobiles manufactured or imported before the date that occurs 15 days after general labels have been determined by the manufacturer, as described in § 600.210-08(b) or § 600.210-12(b). (i) If the manufacturer elects to use a specific label within a model type (as defined in § 600.002, he shall also affix specific labels on all automobiles within this model type, except on those automobiles manufactured or imported before the date that labels are required to bear range values as required by paragraph (b) of this section, or determined by the Administrator, or as permitted under § 600.310. (ii) If a manufacturer elects to change from general to specific labels or vice versa within a model type, the manufacturer shall, within five calendar days, initiate or discontinue as applicable, the use of specific labels on all vehicles within a model type at all facilities where labels are affixed. (3) For any vehicle for which a specific label is requested which has a combined FTP/HFET-based fuel economy value, as determined in § 600.513, at or below the minimum tax-free value, the following statement must appear on the specific label: “[Manufacturer's name] may have to pay IRS a Gas Guzzler Tax on this vehicle because of the low fuel economy.” (4)(i) At the time a general fuel economy value is determined for a model type, a manufacturer shall, except as provided in paragraph (a)(4)(ii) of this section, relabel, or cause to be relabeled, vehicles which: (A) Have not been delivered to the ultimate purchaser, and (B) Have a combined FTP/HFET-based model type fuel economy value (as determined in § 600.208-08(b) or § 600.208-12(b) of 0.1 mpg or more below the lowest fuel economy value at which a Gas Guzzler Tax of $0 is to be assessed. (ii) The manufacturer has the option of re-labeling vehicles during the first five working days after the general label value is known. (iii) For those vehicle model types which have been issued a specific label and are subsequently found to have tax liability, the manufacturer is responsible for the tax liability regardless of whether the vehicle has been sold or not or whether the vehicle has been relabeled or not. (b) The manufacturer shall include the current range of fuel economy of comparable automobiles (as described in §§ 600.311 and 600.314) in the label of each vehicle manufactured or imported more than 15 calendar days after the current range is made available by the Administrator. (1) Automobiles manufactured or imported before a date 16 or more calendar days after the initial label range is made available under § 600.311 shall include the range from the previous model year. (2) Automobiles manufactured or imported more than 15 calendar days after the label range is made available under § 600.311 shall be labeled with the current range of fuel economy of comparable automobiles as approved for that label. (c) The fuel economy label must be readily visible from the exterior of the automobile and remain affixed until the time the automobile is delivered to the ultimate consumer. (1) It is preferable that the fuel economy label information be incorporated into the Automobile Information Disclosure Act label, provided that the prominence and legibility of the fuel economy label is maintained. For this purpose, all fuel economy label information must be placed on a separate section in the Automobile Information Disclosure Act label and may not be intermixed with that label information, except for vehicle descriptions as noted in § 600.303-08(d)(1). (2) The fuel economy label must be located on a side window. If the window is not large enough to contain both the Automobile Information Disclosure Act label and the fuel economy label, the manufacturer shall have the fuel economy label affixed on another window and as close as possible to the Automobile Information Disclosure Act label. (3) The manufacturer shall have the fuel economy label affixed in such a manner that appearance and legibility are maintained until after the vehicle is delivered to the ultimate consumer. (d) The labeling requirements specified in this subpart for 2008 model year vehicles continue to apply through the 2011 model year. In the 2012 model year, manufacturers may label their vehicles as specified in this subpart for either 2008 or 2012 model years. The labeling requirements specified in this subpart for 2012 model year vehicles are mandatory for 2013 and later model years." 40:40:32.0.1.4.44.4.13.10,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.313-08 Timetable for data and information submittal and review.,EPA,,,"[64 FR 23975, May 4, 1999. Redesignated at 76 FR 39558, July 6, 2011]","(a) A manufacturer shall submit to the Administrator fuel economy label values and sufficient information to determine fuel economy label values within the following time constraints (except for manufacturers designated under § 600.312(a)(4) who shall submit the information no later than thirty calendar days prior to the date the model type [vehicle] is initially offered for sale. (1) For initial general label values, no later than five working days before the date that the model type is initially offered for sale; (2) For specific label values, no later than five working days before any vehicles are offered for sale; (3) For model types having label values updated because of running changes (as required under § 600.314(b)), the submission must be made at least five working days before the date of implementation of the running change. (b) A manufacturer may not proceed with any label calculation until the data from each vehicle used in such calculation satisfies the requirements of § 600.008, except as allowed under the provisions of § 600.314-01(e) and approved by the Administrator. (c) If the Administrator has waived any testing in paragraph (b) of this section and subsequently finds that the decision to waive testing was based on an incorrect data submission or that a fuel economy offset exists (based on subsequent testing of that manufacturer's product line), the Administrator may require confirmation of the data generated by any such waived vehicle." 40:40:32.0.1.4.44.4.13.11,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,"§ 600.314-08 Updating label values, annual fuel cost, Gas Guzzler Tax, and range of fuel economy for comparable automobiles.",EPA,,,"[76 FR 39565, July 6, 2011]","(a) The label values established in § 600.312 shall remain in effect for the model year unless updated in accordance with paragraph (b) of this section. (b)(1) The manufacturer shall recalculate the model type fuel economy values for any model type containing base levels affected by running changes specified in § 600.507. (2) For separate model types created in § 600.209-08(a)(2) or § 600.209-12(a)(2), the manufacturer shall recalculate the model type values for any additions or deletions of subconfigurations to the model type. Minimum data requirements specified in § 600.010(c) shall be met prior to recalculation. (3) Label value recalculations shall be performed as follows: (i) The manufacturer shall use updated total model year projected sales for label value recalculations. (ii) All model year data approved by the Administrator at the time of the recalculation for that model type shall be included in the recalculation. (iii) Using the additional data under this paragraph (b), the manufacturer shall calculate new model type city and highway values in accordance with § 600.210 except that the values shall be rounded to the nearest 0.1 mpg. (iv) The existing label values, calculated in accordance with § 600.210, shall be rounded to the nearest 0.1 mpg. (4)(i) If the recalculated city or highway fuel economy value in paragraph (b)(3)(iii) of this section is less than the respective city or highway value in paragraph (b)(3)(iv) of this section by 1.0 mpg or more, the manufacturer shall affix labels with the recalculated model type values (rounded to the nearest whole mpg) to all new vehicles of that model type beginning on the day of implementation of the running change. (ii) If the recalculated city or highway fuel economy value in paragraph (b)(3)(iii) of this section is higher than the respective city or highway value in paragraph (b)(3)(iv) of this section by 1.0 mpg or more, then the manufacturer has the option to use the recalculated values for labeling the entire model type beginning on the day of implementation of the running change. (c) For fuel economy labels updated using recalculated fuel economy values determined in accordance with paragraph (b) of this section, the manufacturer shall concurrently update all other label information (e.g., the annual fuel cost, range of comparable vehicles and the applicability of the Gas Guzzler Tax as needed). (d) The Administrator shall periodically update the range of fuel economies of comparable automobiles based upon all label data supplied to the Administrator. (e) The manufacturer may request permission from the Administrator to calculate and use label values based on test data from vehicles which have not completed the Administrator-ordered confirmatory testing required under the provisions of § 600.008-08(b). If the Administrator approves such a calculation the following procedures shall be used to determine if relabeling is required after the confirmatory testing is completed. (1) The Administrator-ordered confirmatory testing shall be completed as quickly as possible. (2) Using the additional data under paragraph (e)(1) of this section, the manufacturer shall calculate new model type city and highway values in accordance with §§ 600.207 and 600.210 except that the values shall be rounded to the nearest 0.1 mpg. (3) The existing label values, calculated in accordance with § 600.210, shall be rounded to the nearest 0.1 mpg. (4) The manufacturer may need to revise fuel economy labels as follows: (i) If the recalculated city or highway fuel economy value in paragraph (b)(3)(iii) of this section is less than the respective city or highway value in paragraph (b)(3)(iv) of this section by 0.5 mpg or more, the manufacturer shall affix labels with the recalculated model type MPG values (rounded to the nearest whole number) to all new vehicles of that model type beginning 15 days after the completion of the confirmatory test. (ii) If both the recalculated city or highway fuel economy value in paragraph (b)(3)(iii) of this section is less than the respective city or highway value in paragraph (b)(3)(iv) of this section by 0.1 mpg or more and the recalculated gas guzzler tax rate determined under the provisions of § 600.513-08 is larger, the manufacturer shall affix labels with the recalculated model type values and gas guzzler tax statement and rates to all new vehicles of that model type beginning 15 days after the completion of the confirmatory test. (5) For fuel economy labels updated using recalculated fuel economy values determined in accordance with paragraph (e)(4) of this section, the manufacturer shall concurrently update all other label information (e.g., the annual fuel cost, range of comparable vehicles and the applicability of the Gas Guzzler Tax if required by Department of Treasury regulations)." 40:40:32.0.1.4.44.4.13.12,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.315-08 Classes of comparable automobiles.,EPA,,,"[71 FR 77952, Dec. 27, 2006; 72 FR 7921, Feb. 21, 2007, as amended at 74 FR 61552, Nov. 25, 2009; 76 FR 39566, July 6, 2011]","(a) The Secretary will classify automobiles as passenger automobiles or light trucks (nonpassenger automobiles) in accordance with 49 CFR part 523. (1) The Administrator will classify passenger automobiles by car line into one of the following classes based on interior volume index or seating capacity except for those passenger automobiles which the Administrator determines are most appropriately placed in a different classification or classed as special purpose vehicles as provided in paragraph (a)(3) of this section. (i) Two seaters. A car line shall be classed as “Two Seater” if the majority of the vehicles in that car line have no more than two designated seating positions as such term is defined in the regulations of the National Highway Traffic Safety Administration, Department of Transportation (DOT), 49 CFR 571.3. (ii) Minicompact cars. Interior volume index less than 85 cubic feet. (iii) Subcompact cars. Interior volume index greater than or equal to 85 cubic feet but less than 100 cubic feet. (iv) Compact cars. Interior volume index greater than or equal to 100 cubic feet but less than 110 cubic feet. (v) Midsize cars. Interior volume index greater than or equal to 110 cubic feet but less than 120 cubic feet. (vi) Large cars. Interior volume index greater than or equal to 120 cubic feet. (vii) Small station wagons. Station wagons with interior volume index less than 130 cubic feet. (viii) Midsize station wagons. Station wagons with interior volume index greater than or equal to 130 cubic feet but less than 160 cubic feet. (ix) Large station wagons. Station wagons with interior volume index greater than or equal to 160 cubic feet. (2) The Administrator will classify light trucks (nonpassenger automobiles) into the following classes: Small pickup trucks, standard pickup trucks, vans, minivans, and SUVs. Starting in the 2013 model year, SUVs will be divided between small sport utility vehicles and standard sport utility vehicles. Pickup trucks and SUVs are separated by car line on the basis of gross vehicle weight rating (GVWR). For a product line with more than one GVWR, establish the characteristic GVWR value for the product line by calculating the arithmetic average of all distinct GVWR values less than or equal to 8,500 pounds available for that product line. The Administrator may determine that specific light trucks should be most appropriately placed in a different class or in the special purpose vehicle class as provided in paragraphs (a)(3)(i) and (ii) of this section, based on the features and characteristics of the specific vehicle, consumer information provided by the manufacturer, and other information available to consumers. (i) Small pickup trucks. Pickup trucks with a GVWR below 6,000 pounds. (ii) Standard pickup trucks. Pickup trucks with a GVWR at or above 6,000 pounds and at or below 8,500 pounds. (iii) Vans. (iv) Minivans. (v) Small sport utility vehicles. Sport utility vehicles with a GVWR below 6,000 pounds. (vi) Standard sport utility vehicles. Sport utility vehicles with a GVWR at or above 6,000 pounds and at or below 10,000 pounds. (3)(i) Special purpose vehicles. All automobiles with GVWR less than or equal to 8,500 pounds and all medium-duty passenger vehicles which possess special features and which the Administrator determines are more appropriately classified separately from typical automobiles or which do not meet the requirements of paragraphs (a)(1) and (2) of this section will be classified as special purpose vehicles. For example, the Administrator may determine that advanced technology vehicles (such as battery electric vehicles, fuel cell vehicles, plug-in hybrid electric vehicles and vehicles equipped with hydrogen internal combustion engines) should be appropriately classified as a type of “special purpose vehicle.” The Administrator may determine appropriate names for such types of special purpose vehicles, different from the name “special purpose vehicle.” (ii) All automobiles which possess features that could apply to two classes will be classified by the Administrator based on the Administrator's judgment on which class of vehicles consumers are more likely to make comparisons. (4) Once a certain car line is classified by the Administrator, the classification will remain in effect for the model year. (b) Interior volume index—passenger automobiles. (1) The interior volume index shall be calculated for each car line which is not a “two seater” car line, in cubic feet rounded to the nearest 0.1 cubic foot. For car lines with more than one body style, the interior volume index for the car line is the arithmetic average of the interior volume indexes of each body style in the car line. (2) For all body styles except station wagons and hatchbacks with more than one seat (e.g., with a second or third seat) equipped with seatbelts as required by DOT safety regulations, interior volume index is the sum, rounded to the nearest 0.1 cubic feet, of the front seat volume, the rear seat volume(s), if applicable, and the luggage capacity. (3) For all station wagons and hatchbacks with more than one seat (e.g., with a second or third seat) equipped with seatbelts as required by DOT safety regulations, interior volume index is the sum, rounded to the nearest 0.1 cubic feet, of the front seat volume, the rear seat volume, and the cargo volume index. (c) All interior and cargo dimensions are measured in inches to the nearest 0.1 inch. All dimensions and volumes shall be determined from the base vehicles of each body style in each car line, and do not include optional equipment. The dimensions H61, W3, W5, L34, H63, W4, W6, L51, H201, L205, L210, L211, H198, W201, and volume V1 are to be determined in accordance with the procedures outlined in Motor Vehicle Dimensions SAE 1100a (incorporated by reference in § 600.011), except as follows: (1) SAE J1100a(2.3)—Cargo dimensions. All dimensions are measured with the front seat positioned the same as for the interior dimensions and the second seat, for the station wagons and hatchbacks, in the upright position. All head restraints shall be in the stowed position and considered part of the seat. (2) SAE J1100a(8)—Luggage capacity. Total of columns of individual pieces of standard luggage set plus H boxes stowed in the luggage compartment in accordance with the procedure described in 8.2. For passenger automobiles with no rear seat or with two rear seats with no rear seatbelts, the luggage compartment shall include the area to the rear of the front seat, with the rear seat (if applicable) folded, to the height of a horizontal plane tangent to the top of the front seatback. (3) SAE J1100a(7)—Cargo dimensions. (i) L210-Cargo length at second seatback height-hatchback. The minimum horizontal dimension from the “X” plane tangent to the rearmost surface of the second seatback to the inside limiting interference of the hatchback door on the zero “Y” plane. (ii) L211—Cargo length at floor-second-hatchback. The minimum horizontal dimensions at floor level from the rear of the second seatback to the normal limiting interference of the hatchback door on the vehicle zero “Y” plane. (iii) H198—Second seatback to load floor height. The dimension measured vertically from the horizontal tangent to the top of the second seatback to the undepressed floor covering. (d) The front seat volume is calculated in cubic feet by dividing 1,728 into the product of three terms listed below and rounding the quotient to the nearest 0.001 cubic feet: (1) H61—Effective head room-front. (In inches, obtained according to paragraph (c) of this section), (2)(i) (W3 + W5 + 5)/2-Average of shoulder and hip room-front, if hip room is more than 5 inches less than shoulder room. (In inches, W3 and W5 are obtained according to paragraph (c) of this section), or (ii) W3-Shoulder room-front, if hip room is not more than 5 inches less than shoulder room. (In inches, W3 is obtained according to paragraph (c) of this section), and (3) L34—Maximum effective leg room-accelerator. (In inches, obtained according to paragraph (c) of this section.) Round the quotient to the nearest 0.001 cubic feet. (e) The rear seat volume is calculated in cubic feet, for vehicles with a rear seat equipped with rear seat belts (as required by DOT), by dividing 1,728 into the product of three terms listed below and rounding the quotient to the nearest 0.001 cubic feet: (1) H63—Effective head room-second. (Inches obtained according to paragraph (c) of this section), (2)(i) (W4 + W6 + 5)/2-Average of shoulder and hip room-second, if hip room is more than 5 inches less than shoulder room. (In inches, W4 and W6 are obtained according to paragraph (c) of this section), or (ii) W4—Shoulder room-second, if hip room is not more than 5 inches less than shoulder room. (In inches, W4 is obtained according to paragraph (c) of this section), and (3) L51—Minimum effective leg room-second. (In inches obtained according to paragraph (c) of this section.) (f) The luggage capacity is V1, the usable luggage capacity obtained according to paragraph (c) of this section. For passenger automobiles with no rear seat or with a rear seat but no rear seat belts, the area to the rear of the front seat shall be included in the determination of V1, usable luggage capacity, as outlined in paragraph (c) of this section. (g) Cargo volume index. (1) For station wagons the cargo volume index V10 is calculated, in cubic feet, by dividing 1,728 into the product of three terms and rounding the quotient to the nearest 0.001 cubic feet: (i) Average cargo width, which is the arithmetic average of: (A) W4—Shoulder room-second (in inches obtained according to paragraph (c) of this section); and (B) W201—Cargo width-wheelhouse (in inches obtained according to paragraph (c) of this section). (ii) H201-Cargo height. (In inches obtained according to paragraph (c) of this section.) (iii) L205-Cargo length at belt-second. (In inches obtained according to paragraph (c) of this section.) (2) For hatchbacks, the cargo volume index V11 is calculated, in cubic feet, by dividing 1,728 into the product of three terms and rounding the quotient to the nearest 0.001 cubic foot: (i) Average cargo length, which is the arithmetic average of: (A) L210-Cargo length at second seatback height-hatchback. (In inches obtained according to paragraph (c) of this section); (B) L211-Cargo length at floor-second-hatchback. (In inches obtained according to paragraph (c) of this section); (ii) W4-Shoulder room-second. (In inches obtained according to paragraph (c) of this section); (iii) H198—Second seatback to load floor height. (In inches obtained according to paragraph (c) of this section.) (h) The following data must be submitted to the Administrator no later than the time of a general label request. Data shall be included for each body style in the car line covered by that general label. (1) For all passenger automobiles: (i) Dimensions H61, W3, L34 determined in accordance with paragraph (c) of this section. (ii) Front seat volume determined in accordance with paragraph (d) of this section. (iii) Dimensions H63, W4, L51 (if applicable) determined in accordance with paragraph (c) of this section. (iv) Rear seat volume (if applicable) determined in accordance with paragraph (e) of this section. (v) The interior volume index determined in accordance with paragraph (b) of this section for: (A) Each body style, and (B) The car line. (vi) The class of the car line as determined in paragraph (a) of this section. (2) For all passenger automobiles except station wagons and hatchbacks with more than one seat (e.g., with a second or third seat) equipped with seat belts as required by DOT safety regulations: (i) The quantity and letter designation of the pieces of the standard luggage set installed in the vehicle in the determination of usable luggage capacity V1, and (ii) The usable luggage capacity V1, determined in accordance with paragraph (f) of this section. (3) For station wagons with more than one seat (e.g., with a second or third seat) equipped with seat belts as required by DOT safety regulations: (i) The dimensions H201, L205, and W201 determined in accordance with paragraph (c) of this section, and (ii) The cargo volume index V10 determined in accordance with paragraph (g)(1) of this section. (4) For hatchbacks with more than one seat (e.g., with a second or third seat) equipped with seat belts as required by DOT safety regulations: (i) The dimensions L210, L211, and H198 determined in accordance with paragraph (c) of this section. (ii) The cargo volume index V11 determined in accordance with paragraph (g)(2) of this section. (5) For pickup trucks: (i) All GVWR's of less than or equal to 8,500 pounds available in the car line. (ii) The arithmetic average GVWR for the car line." 40:40:32.0.1.4.44.4.13.13,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.316-08 Multistage manufacture.,EPA,,,"[76 FR 39566, July 6, 2011]","Where more than one person is the manufacturer of a vehicle, the final stage manufacturer (as defined in 49 CFR 529.3) is treated as the vehicle manufacturer for purposes of compliance with this subpart." 40:40:32.0.1.4.44.4.13.2,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.302-12 Fuel economy label—general provisions.,EPA,,,"[76 FR 39559, July 6, 2011, as amended at 76 FR 57380, Sept. 15, 2011]","This section describes labeling requirements and specifications that apply to all vehicles. The requirements and specifications in this section and those in §§ 600.304 through 600.310 are illustrated in Appendix VI of this part. (a) Basic format. Fuel economy labels must be rectangular in shape with a minimum width of 174 mm and a minimum height of 114 mm. The required label can be divided into three fields separated and outlined by a continuous border, as described in paragraphs (b) through (e) of this section. (b) Border. Create a continuous black border to outline the label and separate the three information fields. Include the following information in the top and bottom portions of the border: (1) In the left portion of the upper border, include “EPA” and “DOT” with a horizontal line in between (“EPA divided by DOT”). (2) Immediately to the right of the Agency names, include the heading “Fuel Economy and Environment”. (3) Identify the vehicle's fuel type on the right-most portion of the upper border in a blue-colored field as follows: (i) For vehicles designed to operate on a single fuel, identify the appropriate fuel. For example, identify the vehicle as “Gasoline Vehicle”, “Diesel Vehicle”, “Compressed Natural Gas Vehicle”, “Hydrogen Fuel Cell Vehicle”, etc. This includes hybrid electric vehicles that do not have plug-in capability. Include a logo corresponding to the fuel to the left of this designation as follows: (A) For gasoline, include a fuel pump logo. (B) For diesel fuel, include a fuel pump logo with a “D” inscribed in the base of the fuel pump. (C) For natural gas, include the established CNG logo. (D) For hydrogen fuel cells, include the expression “H 2 ”. (ii) Identify flexible-fuel vehicles and dual-fuel vehicles as “Flexible-Fuel Vehicle Gasoline-Ethanol (E85)”, “Flexible-Fuel Vehicle Diesel-Natural Gas”, etc. Include a fuel pump logo or a combination of logos to the left of this designation as appropriate. For example, for vehicles that operate on gasoline or ethanol, include a fuel pump logo and the designation “E85”. (iii) Identify plug-in hybrid electric vehicles as “Plug-In Hybrid Vehicle Electricity-Gasoline” or “Plug-In Hybrid Vehicle Electricity-Diesel”. Include a fuel pump logo as specified in paragraph (b)(3)(i) of this section and an electric plug logo to the left of this designation. (iv) Identify electric vehicles as “Electric Vehicle”. Include an electric plug logo to the left of this designation. (4) Include the following statement in the upper left portion of the lower border: “Actual results will vary for many reasons, including driving conditions and how you drive and maintain your vehicle. The average new vehicle gets a MPG and costs $ b to fuel over 5 years. Cost estimates are based on c miles per year at $ d per gallon. MPGe is miles per gasoline gallon equivalent. Vehicle emissions are a significant cause of climate change and smog.” For a, b, c, and d, insert the appropriate values established by EPA, including consideration of the type of fuel that is required for the vehicle. See §§ 600.303 through 600.310 for alternate statements that apply for vehicles that use a fuel other than gasoline or diesel fuel. (5) In the lower left portion of the lower border, include the Web site reference, “fueleconomy.gov”, and the following statement: “Calculate personalized estimates and compare vehicles”. (6) Include a field in the right-most portion of the lower border to allow for accessing interactive information with mobile electronic devices. To do this, include an image of a QR code that will direct mobile electronic devices to an EPA-specified Web site with fuel economy information. Generate the QR code as specified in ISO/IEC 18004 (incorporated by reference in § 600.011). To the left of the QR code, include the vertically oriented caption “Smartphone QR Code TM ”. (7) Along the lower edge of the lower border, to the left of the field with the QR Code, include the logos for EPA, the Department of Transportation, and the Department of Energy. (c) Fuel economy and cost values. Include the following elements in the field at the top of the label: (1) The elements specified in this paragraph (c)(1) for vehicles that run on gasoline or diesel fuel with no plug-in capability. See §§ 600.304 through 600.310 for specifications that apply for other vehicles. (i) The heading “Fuel Economy” near the top left corner of the field. (ii) The combined fuel economy value as determined in § 600.311 below the heading. Include the expression “combined city/hwy” below this number. (iii) The fuel pump logo to the left of the combined fuel economy value. For diesel fuel, include a fuel pump logo with a “D” inscribed in the base of the fuel pump. (iv) The units identifier and specific fuel economy values to the right of the combined fuel economy rating as follows: (A) Include the term “MPG” in the upper portion of the designated space. (B) Include the city fuel economy value determined in § 600.311 in the lower left portion of the designated space. Include the expression “city” below this number. (C) Include the highway fuel economy value determined in § 600.311 in the lower right portion of the designated space. Include the expression “highway” below this number. (v) The fuel consumption rate determined in § 600.311, below the combined fuel economy value, followed by the expression “gallons per 100 miles”. (2) In the upper middle portion of the field, include the following statement: “___ range from x to y MPG. The best vehicle rates z MPGe.” Fill in the blank with the appropriate vehicle class (such as Small SUVs). For x, y, and z, insert the appropriate values established by EPA. (3) Include one of the following statements in the right side of the field: (i) For vehicles with calculated fuel costs higher than the average vehicle as specified in § 600.311: “You spend $ x more in fuel costs over 5 years compared to the average new vehicle.” Complete the statement by including the calculated increase in fuel costs as specified in § 600.311. (ii) For all other vehicles: “You save $ x in fuel costs over 5 years compared to the average new vehicle.” Complete the statement by including the calculated fuel savings as specified in § 600.311. Note that this includes fuel savings of $0. (d) Annual fuel cost. Include the following statement in the field in the lower left portion of the label: “Annual fuel cost $ x”. Complete this statement using the value for annual fuel cost determined in § 600.311. (e) Performance ratings. Include the following information in the field in the lower left portion of the label: (1) The heading, “Fuel Economy and Greenhouse Gas Rating (tailpipe only)” in the top left corner of the field. (2) A slider bar below the heading in the left portion of the field to characterize the vehicle's fuel economy and greenhouse gas ratings, as determined in § 600.311. Position a box with a downward-pointing wedge above the slider bar positioned to show where that vehicle's fuel economy rating falls relative to the total range; include the vehicle's fuel economy rating inside the box. If the greenhouse gas rating from § 600.311 is different than the fuel economy rating, position a second box with an upward-pointing wedge below the slider bar positioned to show where that vehicle's greenhouse gas rating falls relative to the total range; include the vehicle's greenhouse gas rating inside the box. Include the expression “CO 2 ” to the left of the box with the greenhouse gas rating and add the expression MPG to the left of the box with the fuel economy rating. Include the number 1 inside the border at the left end of the slider bar. Include the number 10 inside the border at the right end of the slider bar and add the term “Best” below the slider bar, directly under the number. EPA will periodically calculate and publish updated rating values as described in § 600.311. Add color to the slider bar such that it is blue at the left end of the range, white at the right end of the range, and shaded continuously across the range. (3) The heading, “Smog Rating (tailpipe only)” in the top right corner of the field. (4) Insert a slider bar in the right portion of the field to characterize the vehicle's level of emission control for ozone-related air pollutants relative to that of all vehicles. Position a box with a downward-pointing wedge above the slider bar positioned to show where that vehicle's emission rating falls relative to the total range. Include the vehicle's emission rating (as described in § 600.311) inside the box. Include the number 1 in the border at the left end of the slider bar; include the number 10 in the border at the right end of the slider bar and add the term “Best” below the slider bar, directly under the number. EPA will periodically calculate and publish updated range values as described in § 600.311. Add color to the slider bar such that it is blue at the left end of the range, white at the right end of the range, and shaded continuously across the range. (5) The following statements below the slider bars: “This vehicle emits x grams CO 2 per mile. The best emits 0 grams per mile (tailpipe only). Producing and distributing fuel also create emissions; learn more at fueleconomy.gov.” For x, insert the vehicle's composite CO 2 emission rate as described in § 600.311. See §§ 600.308 and 600.310 for specifications that apply for vehicles powered by electricity. (f) Vehicle description. Where the fuel economy label is physically incorporated with the Motor Vehicle Information and Cost Savings Act label, no further vehicle description is needed. If the fuel economy label is separate from the Automobile Information Disclosure Act label, describe the vehicle in a location on the label that does not interfere with the other required information. In cases where the vehicle description may not easily fit on the label, the manufacturer may request Administrator approval of modifications to the label format to accommodate this information. Include the following items in the vehicle description, if applicable: (1) Model year. (2) Vehicle car line. (3) Engine displacement, in cubic inches, cubic centimeters, or liters whichever is consistent with the customary description of that engine. (4) Transmission class. (5) Other descriptive information, as necessary, such as number of engine cylinders, to distinguish otherwise identical model types or, in the case of specific labels, vehicle configurations, as approved by the Administrator. (g) [Reserved] (h) Gas guzzler provisions. For vehicles requiring a tax statement under § 600.513, add the phrase “$ x gas guzzler tax”, where $ x is the value of the tax. The tax value required by this paragraph (h) is based on the combined fuel economy value for the model type calculated according to § 600.513 and rounded to the nearest 0.1 mpg. (i) Alternative label provisions for special cases. The Administrator may approve modifications to the style guidelines if space is limited. The Administrator may also prescribe special label format and information requirements for vehicles that are not specifically described in this subpart, such as hydrogen-fueled internal combustion engines or hybrid electric vehicles that have engines operating on fuels other than gasoline or diesel fuel. The Administrator may also approve alternate wording of statements on the label if that is necessary or appropriate for a given fuel or combination of fuels. The revised labeling specifications will conform to the principles established in this subpart, with any appropriate modifications or additions to reflect the vehicle's unique characteristics. See 49 U.S.C. 32908(b)(1)(F). (j) Rounding. Unless the regulation specifies otherwise, do not round intermediate values, but round final calculated values identified in this subpart to the nearest whole number. (k) Updating information. EPA will periodically publish updated information that is needed to comply with the labeling requirements in this subpart. This includes the annual mileage rates and fuel-cost information, the “best and worst” values needed for calculating relative ratings for individual vehicles, and the various rating criteria as specified in § 600.311." 40:40:32.0.1.4.44.4.13.3,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.303-12 Fuel economy label—special requirements for flexible-fuel vehicles.,EPA,,,"[76 FR 39561, July 6, 2011, as amended at 77 FR 63183, Oct. 15, 2012]","Fuel economy labels for flexible-fuel vehicles must meet the specifications described in § 600.302, with the modifications described in this section. This section describes how to label flexible-fuel vehicles equipped with gasoline engines. If the vehicle has a diesel engine, all the references to “gas” or “gasoline” in this section are understood to refer to “diesel” or “diesel fuel”, respectively. All values described in this section are based on gasoline operation, unless otherwise specifically noted. (a) For qualifying vehicles, include the following additional sentence in the statement identified in § 600.302-12(b)(4): “This is a dual fueled automobile.” See the definition of “dual fueled automobile” in § 600.002. (b) Include the following elements instead of the information identified in § 600.302-12(c)(1): (1) The heading “Fuel Economy” near the top left corner of the field. (2) The combined fuel economy value as determined in § 600.311 below the heading. Include the expression “combined city/hwy” below this number. (3) The fuel pump logo and other logos as specified in § 600.302-12(b)(3)(ii) to the left of the combined fuel economy value. (4) The units identifier and specific fuel economy values to the right of the combined fuel economy value as follows: (i) Include the term “MPG” in the upper portion of the designated space. (ii) Include the city fuel economy value determined in § 600.311 in the lower left portion of the designated space. Include the expression “city” below this number. (iii) Include the highway fuel economy value determined in § 600.311 in the lower right portion of the designated space. Include the expression “highway” below this number. (5) The fuel consumption rate determined in § 600.311, to the right of the fuel economy information. Include the expression “gallons per 100 miles” below the numerical value. (6) Add the following statement after the statements described in § 600.302-12(c)(2): “Values are based on gasoline and do not reflect performance and ratings based on E85.” Adjust this statement as appropriate for vehicles designed to operate on different fuels. (c) You may include the sub-heading “Driving Range” below the combined fuel economy value, with range bars below this sub-heading as follows: (1) Insert a horizontal range bar nominally 80 mm long to show how far the vehicle can drive from a full tank of gasoline. Include a vehicle logo at the right end of the range bar. Include the following left-justified expression inside the range bar: “Gasoline: x miles”. Complete the expression by identifying the appropriate value for total driving range from § 600.311. (2) Insert a second horizontal range bar as described in paragraph ( c )( 1 ) of this section that shows how far the vehicle can drive from a full tank with the second fuel. Establish the length of the line based on the proportion of driving ranges for the different fuels. Identify the appropriate fuel in the range bar." 40:40:32.0.1.4.44.4.13.4,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.304-12 Fuel economy label—special requirements for hydrogen fuel cell vehicles.,EPA,,,"[76 FR 39561, July 6, 2011]","Fuel economy labels for hydrogen fuel cell vehicles must meet the specifications described in § 600.302, with the following modifications: (a) Include the following statement instead of the statement specified in § 600.302-12(b)(4): “Actual results will vary for many reasons, including driving conditions and how you drive and maintain your vehicle. The average new vehicle gets a MPG and costs $ b to fuel over 5 years. Cost estimates are based on c miles per year at $ d per kilogram of hydrogen. Vehicle emissions are a significant cause of global warming and smog.” For a, b, c, and d, insert the appropriate values established by EPA. (b) Include the following elements instead of the information identified in § 600.302-12(c)(1): (1) The heading “Fuel Economy” near the top left corner of the field. (2) The combined fuel economy value as determined in § 600.311 below the heading. Include the expression “combined city/hwy” below this number. (3) The logo specified in § 600.302-12(b)(3)(ii) to the left of the combined fuel economy value. (4) The units identifier and specific fuel economy values to the right of the combined fuel economy value as follows: (i) Include the term “MPGe” in the upper portion of the designated space. (ii) Include the city fuel economy value determined in § 600.311 in the lower left portion of the designated space. Include the expression “city” below this number. (iii) Include the highway fuel economy value determined in § 600.311 in the lower right portion of the designated space. Include the expression “highway” below this number. (5) The fuel consumption rate determined in § 600.311, to the right of the fuel economy information. Include the expression “kg H 2 per 100 miles” below the numerical value. (6) The sub-heading “Driving Range” below the combined fuel economy value. Below this sub-heading, insert a horizontal range bar nominally 80 mm long to show how far the vehicle can drive when fully fueled. Include a vehicle logo at the right end of the range bar. Include the following left-justified expression inside the range bar: “When fully fueled, vehicle can travel about * * *”. Below the right end of the range bar, include the expression “ x miles”; complete the expression by identifying the appropriate value for total driving range from § 600.311. Include numbers below the bar showing the scale, with numbers starting at 0 and increasing in equal increments. Use good engineering judgment to divide the range bar into four, five, or six increments." 40:40:32.0.1.4.44.4.13.5,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.306-12 Fuel economy label—special requirements for compressed natural gas vehicles.,EPA,,,"[76 FR 39562, July 6, 2011]","Fuel economy labels for dedicated natural gas vehicles must meet the specifications described in § 600.302, with the following modifications: (a) Include the following statement instead of the statement specified in § 600.302-12(b)(4): “Actual results will vary for many reasons, including driving conditions and how you drive and maintain your vehicle. The average new vehicle gets a MPG and costs $ b to fuel over 5 years. Cost estimates are based on c miles per year at $ d per gasoline gallon equivalent. Vehicle emissions are a significant cause of global warming and smog.” For a, b, c, and d, insert the appropriate values established by EPA. (b) Include the following elements instead of the information identified in § 600.302-12(c)(1): (1) The heading “Fuel Economy” near the top left corner of the field. (2) The combined fuel economy value as determined in § 600.311 below the heading. Include the expression “combined city/hwy” below this number. (3) The logo specified in § 600.302-12(b)(3)(ii) to the left of the combined fuel economy value. (4) The units identifier and specific fuel economy ratings to the right of the combined fuel economy value as follows: (i) Include the term “MPGe” in the upper portion of the designated space. (ii) Include the city fuel economy value determined in § 600.311 in the lower left portion of the designated space. Include the expression “city” below this number. (iii) Include the highway fuel economy value determined in § 600.311 in the lower right portion of the designated space. Include the expression “highway” below this number. (5) The fuel consumption rate determined in § 600.311, to the right of the fuel economy information. Include the expression “equivalent gallons per 100 miles” below the numerical value. (6) The sub-heading “Driving Range” below the combined fuel economy value. Below this sub-heading, insert a horizontal range bar nominally 80 mm long to show how far the vehicle can drive when fully fueled. Include a vehicle logo at the right end of the range bar. Include the following left-justified expression inside the range bar: “When fully fueled, vehicle can travel about * * *””. Below the right end of the range bar, include the expression “ x miles”; complete the expression by identifying the appropriate value for total driving range from § 600.311. Include numbers below the bar showing the scale, with numbers starting at 0 and increasing in equal increments. Use good engineering judgment to divide the range bar into four, five, or six increments." 40:40:32.0.1.4.44.4.13.6,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.308-12 Fuel economy label format requirements—plug-in hybrid electric vehicles.,EPA,,,"[76 FR 39562, July 6, 2011]","Fuel economy labels for plug-in hybrid electric vehicles must meet the specifications described in § 600.302, with the exceptions and additional specifications described in this section. This section describes how to label vehicles equipped with gasoline engines. If the vehicle has a diesel engine, all the references to “gas” or “gasoline” in this section are understood to refer to “diesel” or “diesel fuel”, respectively. (a) Include the following statement instead of the statement specified in § 600.302-12(b)(4): “Actual results will vary for many reasons, including driving conditions and how you drive and maintain your vehicle. The average new vehicle gets a MPG and costs $ b to fuel over 5 years. Cost estimates are based on c miles per year at $ d per gallon and $ e per kW-hr. Vehicle emissions are a significant cause of global warming and smog.” For a, b, c, d, and e, insert the appropriate values established by EPA. For qualifying vehicles, include the following additional sentence: “This is a dual fueled automobile.” See the definition of “dual fueled automobile in § 600.002. (b) Include the following elements instead of the information identified in § 600.302-12(c)(1): (1) The heading “Fuel Economy” near the top left corner of the field. Include the statement specified in § 600.312-12(c)(2) to the right of the heading. (2) An outlined box below the heading with the following information: (i) The sub-heading “Electricity” if the vehicle's engine starts only after the battery is fully discharged, or “Electricity + Gasoline” if the vehicle uses combined power from the battery and the engine before the battery is fully discharged. (ii) The expression “Charge Time: x hours (240V)” below the sub-heading, where x is the time to charge the battery as specified in § 600.311. Change the specified voltage if appropriate as specified in § 600.311. (iii) The combined fuel economy value for the charge-depleting mode of operation as determined in § 600.311 below the charge time. Include the expression “combined city/highway” below this number. (iv) An electric plug logo to the left of the combined fuel economy value. For vehicles that use combined power from the battery and the engine before the battery is fully discharged, also include the fuel pump logo. (v) The units identifier and consumption ratings to the right of the combined fuel economy value as follows: (A) Include the term “MPGe” in the upper portion of the designated space. (B) If the vehicle's engine starts only after the battery is fully discharged, identify the vehicle's electricity consumption rate as specified in § 600.311. Below the number, include the expression: “kW-hrs per 100 miles”. (C) If the vehicle uses combined power from the battery and the engine before the battery is fully discharged, identify the vehicle's gasoline consumption rate as specified in § 600.311; to the right of this number, include the expression: “gallons per 100 miles”. Below the gasoline consumption rate, identify the vehicle's electricity consumption rate as specified in § 600.311; to the right of this number, include the expression: “kW-hrs per 100 miles”. (3) A second outlined box to the right of the box described in paragraph (b)(2) of this section with the following information: (i) The sub-heading “Gasoline Only”. (ii) The combined fuel economy value for operation after the battery is fully discharged as determined in § 600.311 below the sub-heading. Include the expression “combined city/highway” below this number. (iii) A fuel pump logo to the left of the combined fuel economy value. (iv) The units identifier and consumption rating to the right of the combined fuel economy value as follows: (A) Include the term “MPG” in the upper portion of the designated space. (B) Identify the vehicle's gasoline consumption rate as specified in § 600.311. Below this number, include the expression: “gallons per 100 miles”. (4) Insert a horizontal range bar below the boxes specified in paragraphs (b)(2) and (3) of this section that shows how far the vehicle can drive before the battery is fully discharged, and also how far the vehicle can drive before running out of fuel, as described in § 600.311. Scale the range bar such that the driving range at the point of fully discharging the battery is directly between the two boxes. Identify the driving range up to fully discharging the battery underneath that point on the range bar (e.g., “50 miles”). Use solid black for the gasoline-only portion of the range bar. Include the left-justified expression “Gasoline only” in the gasoline-only portion of the range bar. Similarly, in the electric portion of the range bar, include the left-justified expression “All electric range” if the vehicle's engine starts only after the battery is fully discharged, or “Electricity + Gasoline” if the vehicle uses combined power from the battery and the engine before the battery is fully discharged. Include a vehicle logo at the right end of the range bar. Extend an arrow from the battery portion of the range bar up to the right side of the box described in paragraph (b)(2) of this section. Similarly, extend an arrow from the gasoline-only portion of the range bar up to the left side of the box described in paragraph (b)(3) of this section. Include numbers below the bar showing the scale, with at least three evenly spaced increments to cover operation before the battery is fully discharged. Include one more increment using that same scale into the gasoline-only portion of the range bar. Indicate a broken line toward the right end of the range bar, followed by the vehicle's total driving distance before running out of fuel, as described in § 600.311. Adjust the scale and length of the range bar if the specifications in this paragraph (a)(5) do not work for your vehicle. Include a left-justified heading above the range bar with the expression: “Driving Range”. For vehicles that use combined power from the battery and the engine before the battery is fully discharged, add the following statement below the range bar described in this paragraph (b)(4): “All electric range = x miles”; complete the expression by identifying the appropriate value for driving range starting from a full battery before the engine starts as described in § 600.311. (c) Include the following statement instead of the one identified in § 600.302-12(c)(5): “This vehicle emits x grams CO 2 per mile. The best emits 0 grams per mile (tailpipe only). Producing and distributing fuel and electricity also create emissions; learn more at fueleconomy.gov.” For x, insert the vehicle's composite CO 2 emission rate as described in § 600.311." 40:40:32.0.1.4.44.4.13.7,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.310-12 Fuel economy label format requirements—electric vehicles.,EPA,,,"[76 FR 39563, July 6, 2011, as amended at 77 FR 63184, Oct. 15, 2012]","Fuel economy labels for electric vehicles must meet the specifications described in § 600.302, with the following modifications: (a) Include the following statement instead of the statement specified in § 600.302-12(b)(4): “Actual results will vary for many reasons, including driving conditions and how you drive and maintain your vehicle. The average new vehicle gets a MPG and costs $ b to fuel over 5 years. Cost estimates are based on c miles per year at $ d per kW-hr. MPGe is miles per gasoline gallon equivalent. Vehicle emissions are a significant cause of climate change and smog.” For a, b, c, and d, insert the appropriate values established by EPA. (b) Include the following elements instead of the information identified in § 600.302-12(c)(1): (1) The heading “Fuel Economy” near the top left corner of the field. (2) The combined fuel economy value as determined in § 600.311 below the heading. Include the expression “combined city/hwy” below this number. (3) An electric plug logo to the left of the combined fuel economy value. (4) The units identifier and specific fuel economy values to the right of the combined fuel economy value as follows: (i) Include the term “MPGe” in the upper portion of the designated space. (ii) Include the city fuel economy value determined in § 600.311 in the lower left portion of the designated space. Include the expression “city” below this number. (iii) Include the highway fuel economy value determined in § 600.311 in the lower right portion of the designated space. Include the expression “highway” below this number. (5) The fuel consumption rate determined in § 600.311, to the right of the fuel economy information. Include the expression “kW-hrs per 100 miles” below the numerical value. (6) The sub-heading “Driving Range” below the combined fuel economy value. Below this sub-heading, insert a horizontal range bar nominally 80 mm long to show how far the vehicle can drive when fully fueled. Include a vehicle logo at the right end of the range bar. Include the following left-justified expression inside the range bar: “When fully charged, vehicle can travel about * * *”. Below the right end of the range bar, include the expression “ x miles”; complete the expression by identifying the appropriate value for total driving range from § 600.311. Include numbers below the bar showing the scale, with numbers starting at 0 and increasing in equal increments. Use good engineering judgment to divide the range bar into four, five, or six increments. (7) Below the driving range information, the expression “Charge Time: x hours (240V)”, where x is the time to charge the battery as specified in § 600.311. Change the specified voltage if appropriate as specified in § 600.311. (c) Include the following statement instead of the one identified in § 600.302-12(c)(5): “This vehicle emits x grams CO 2 per mile. The best emits 0 grams per mile (tailpipe only). Does not include emissions from generating electricity; learn more at fueleconomy.gov.” For x, insert the vehicle's composite CO 2 emission rate as described in § 600.311." 40:40:32.0.1.4.44.4.13.8,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,§ 600.311-12 Determination of values for fuel economy labels.,EPA,,,"[76 FR 39563, July 6, 2011, as amended at 76 FR 57380, Sept. 15, 2011; 77 FR 63184, Oct. 15, 2012; 79 FR 23747, Apr. 28, 2014; 81 FR 74002, Oct. 25, 2016; 88 FR 4483, Jan. 24, 2023; 89 FR 28210, Apr. 18, 2024]","(a) Fuel economy. Determine city and highway fuel economy values as described in § 600.210-12(a) and (b). Determine combined fuel economy values as described in § 600.210-12(c). Note that the label for plug-in hybrid electric vehicles requires separate values for combined fuel economy for vehicle operation before and after the vehicle's battery is fully discharged; we generally refer to these modes as “Blended Electric + Gas” (or “Electric Only”, as applicable) and “Gas only”. (b) CO 2 emission rate . Determine the engine-related CO 2 emission rate as described in § 600.210-12(d). (c) Fuel consumption rate. Calculate the fuel consumption rate as follows: (1) For vehicles with engines that are not plug-in hybrid electric vehicles, calculate the fuel consumption rate in gallons per 100 miles (or gasoline gallon equivalent per 100 miles for fuels other than gasoline or diesel fuel) with the following formula, rounded to the first decimal place: Fuel Consumption Rate = 100/MPG Where: MPG = The value for combined fuel economy from § 600.210-12(c), rounded to the nearest whole mpg. Where: MPG = The value for combined fuel economy from § 600.210-12(c), rounded to the nearest whole mpg. (2) For plug-in hybrid electric vehicles, calculate two separate fuel consumption rates as follows: (i) Calculate the fuel consumption rate based on engine operation after the battery is fully discharged as described in paragraph (c)(1) of this section. (ii) Calculate the fuel consumption rate during operation before the battery is fully discharged in kW-hours per 100 miles as described in SAE J1711 (incorporated by reference in § 600.011), as described in § 600.116. (3) For electric vehicles, calculate the fuel consumption rate in kW-hours per 100 miles with the following formula, rounded to the nearest whole number: Fuel Consumption Rate = 100/MPG Where: MPG = The combined fuel economy value from paragraph (a) of this section, in miles per kW-hour. Where: MPG = The combined fuel economy value from paragraph (a) of this section, in miles per kW-hour. (4) For hydrogen fuel cell vehicles, calculate the fuel consumption rate in kilograms of hydrogen per 100 miles with the following formula, rounded to the nearest whole number: Fuel Consumption Rate = 100/MPG Where: MPG = The combined fuel economy value from paragraph (a) of this section, in miles per kilogram of hydrogen. Where: MPG = The combined fuel economy value from paragraph (a) of this section, in miles per kilogram of hydrogen. (d) Fuel economy and greenhouse gas ratings. Determine a vehicle's fuel economy and greenhouse gas ratings as follows: (1) For gasoline-fueled vehicles that are not plug-in hybrid electric vehicles (including flexible fuel vehicles that operate on gasoline), establish a single rating based only on the vehicle's combined fuel economy from paragraph (a) of this section. For all other vehicles, establish a fuel economy rating based on the vehicle's combined fuel economy and establish a separate greenhouse gas rating based on combined CO 2 emission rates from paragraph (b) of this section. (2) We will establish the fuel economy rating based on fuel consumption values specified in paragraph (c) of this section. We will establish the value dividing the 5 and 6 ratings based on the fuel consumption corresponding to the projected achieved Corporate Average Fuel Economy level for the applicable model year. This is intended to prevent below-average vehicles from getting an above-average fuel economy rating for the label. We will establish the remaining cutpoints based on a statistical evaluation of available information from the certification database for all model types. Specifically, the mean value plus two standard deviations will define the point between the 1 and 2 ratings. The mean value minus two standard deviations will define the point between the 9 and 10 ratings. The 1 rating will apply for any vehicle with higher fuel consumption rates than the 2 rating; similarly, the 10 rating will apply for any vehicle with lower fuel consumption rates than the 9 rating. We will calculate range values for the remaining intermediate ratings by dividing the range into equal intervals. We will convert the resulting range intervals to equivalent miles-per-gallon values. We will define the greenhouse gas ratings by converting the values from the fuel economy rating intervals to equivalent CO 2 emission rates using the conventional conversion factor for gasoline (8887 g CO 2 per gallon of consumed fuel). (e) Annual fuel cost. Calculate annual fuel costs as follows: (1) Except as specified in paragraph (e)(3) of this section, calculate the total annual fuel cost with the following formula, rounded to nearest $50: Annual Fuel Cost = Fuel Price/MPG × Average Annual Miles Where: Fuel Price = The estimated fuel price provided by EPA for the type of fuel required for the vehicle. The units are dollars per gallon for gasoline and diesel fuel, dollars per gasoline gallon equivalent for natural gas, dollars per kW-hr for plug-in electricity, and dollars per kilogram of hydrogen for hydrogen fuel cell vehicles. MPG = The combined fuel economy value from paragraph (a) of this section. The units are miles per gallon for gasoline and diesel fuel, miles per gasoline gallon equivalent for natural gas, miles per kW-hr for plug-in electricity, and miles per kilogram of hydrogen for hydrogen fuel cell vehicles. Average Annual Miles = The estimated annual mileage figure provided by EPA, in miles. Where: Fuel Price = The estimated fuel price provided by EPA for the type of fuel required for the vehicle. The units are dollars per gallon for gasoline and diesel fuel, dollars per gasoline gallon equivalent for natural gas, dollars per kW-hr for plug-in electricity, and dollars per kilogram of hydrogen for hydrogen fuel cell vehicles. MPG = The combined fuel economy value from paragraph (a) of this section. The units are miles per gallon for gasoline and diesel fuel, miles per gasoline gallon equivalent for natural gas, miles per kW-hr for plug-in electricity, and miles per kilogram of hydrogen for hydrogen fuel cell vehicles. Average Annual Miles = The estimated annual mileage figure provided by EPA, in miles. (2) For dual fuel vehicles and flexible fuel vehicles, disregard operation on the alternative fuel. (3) For plug-in hybrid electric vehicles, calculate annual fuel cost as described in this paragraph (e)(3). This description applies for vehicles whose engine starts only after the battery is fully discharged. Use good engineering judgment to extrapolate this for calculating annual fuel cost for vehicles that use combined power from the battery and the engine before the battery is fully discharged. Calculate annual fuel cost as follows: (i) Determine the charge-depleting ranges for city and highway operation as described in paragraph (j)(4)(i) of this section. Adjust each of these values for 5-cycle operation. (ii) Calculate multi-day individual utility factors (UF) as described in § 600.116 corresponding to the driving ranges from paragraph (e)(3)(i) of this section. (iii) Calculate values for the vehicle's average fuel economy over the charge-depleting range (in miles per kW-hr) for city and highway operation as described in § 600.210. Adjust each of these values for 5-cycle operation. Convert these to $/mile values by dividing the appropriate fuel price from paragraph (e)(1) of this section by the average fuel economy determined in this paragraph (e)(3)(iii). (iv) Calculate values for the vehicle's average fuel economy over the charge-sustaining range (in miles per gallon) for city and highway operation as described in § 600.210-12. Adjust each of these values for 5-cycle operation. Convert these to $/mile values by dividing the appropriate fuel price from paragraph (e)(1) of this section by the average fuel economy determined in this paragraph (e)(3)(iv). (v) Calculate a composite $/mile value for city driving using the following equation: $/mile = $/mile CD × UF + $/mile CS × (1-UF) (vi) Repeat the calculation in paragraph (e)(3)(v) of this section for highway driving. (vii) Calculate the annual fuel cost based on the combined values for city and highway driving using the following equation: Annual fuel cost = ($/milecity × 0.55 + $/milehwy × 0.45) × Average Annual Miles (4) Round the annual fuel cost to the nearest $50 by dividing the unrounded annual fuel cost by 50, then rounding the result to the nearest whole number, then multiplying this rounded result by 50 to determine the annual fuel cost to be used for purposes of labeling. (f) Fuel savings. Calculate an estimated five-year cost increment relative to an average vehicle by multiplying the annual fuel cost from paragraph (e) of this section by 5 and subtracting this value from the average five-year fuel cost. We will calculate the average five-year fuel cost from the annual fuel cost equation in paragraph (e) of this section based on a gasoline-fueled vehicle with a mean fuel economy value, consistent with the value dividing the 5 and 6 ratings under paragraph (d) of this section. The average five-year fuel cost for model year 2012 is $12,600 for a 22-mpg vehicle that drives 15,000 miles per year with gasoline priced at $3.70 per gallon. We may periodically update this five year reference fuel cost for later model years to better characterize the fuel economy for an average vehicle. Round the calculated five-year cost increment to the nearest $50. Negative values represent a cost increase compared to the average vehicle. (g) Smog rating. Establish a rating for exhaust emissions other than CO 2 based on the applicable emission standards for the appropriate model year as shown in tables 1 through 3 to this paragraph (g). Unless specified otherwise, use the California emission standards to select the smog rating only for vehicles not certified to any EPA standards. For Independent Commercial Importers that import vehicles not subject to the identified emission standards, the vehicle's smog rating is 1. Similarly, if a manufacturer certifies vehicles to emission standards that are less stringent than all the identified standards for any reason, the vehicle's smog rating is 1. If EPA or California emission standards change in the future, we may revise the emission levels corresponding to each rating for future model years as appropriate to reflect the changed standards. If this occurs, we would publish the revised ratings as described in § 600.302-12(k), allowing sufficient lead time to make the changes; we would also expect to initiate a rulemaking to update the smog rating in the regulation. Table 1 to Paragraph (g) —Criteria for Establishing Smog Rating for Model Year 2030 and Later Table 2 to Paragraph (g) —Criteria for Establishing Smog Rating for Model Years 2025 Through 2029 Table 3 to Paragraph (g) —Criteria for Establishing Smog Rating for Model Years 2018 Through 2024 (h) Ranges of fuel economy and CO 2 emission values . We will determine the range of combined fuel economy and CO 2 emission values for each vehicle class identified in § 600.315. We will generally update these range values before the start of each model year based on the lowest and highest values within each vehicle class. We will also use this same information to establish a range of fuel economy values for all vehicles. Continue to use the most recently published numbers until we update them, even if you start a new model year before we publish the range values for the new model year. (i) [Reserved] (j) Driving range. Determine the driving range for certain vehicles as follows: (1) For vehicles operating on nonpressurized liquid fuels, determine the vehicle's driving range in miles by multiplying the combined fuel economy described in paragraph (a) of this section by the vehicle's usable fuel storage capacity, rounded to the nearest whole number. (2) For electric vehicles, determine the vehicle's overall driving range as described in Section 8 of SAE J1634 (incorporated by reference in § 600.011), with amendments and revisions as described in § 600.116. Determine separate range values for FTP-based city and HFET-based highway driving. Adjust these values to represent 5-cycle values as described in § 600.210-12(d)(3), then combine them arithmetically by averaging the two values, weighted 0.55 and 0.45, respectively, and rounding to the nearest whole number. (3) For natural gas vehicles, determine the vehicle's driving range in miles by multiplying the combined fuel economy described in paragraph (a) of this section by the vehicle's usable fuel storage capacity (expressed in gasoline gallon equivalents), rounded to the nearest whole number. (4) For plug-in hybrid electric vehicles, determine the adjusted charge-depleting (Rcda) driving range, the adjusted all electric driving range (if applicable), and overall adjusted driving range as described in SAE J1711 (incorporated by reference in § 600.011), as described in § 600.116, as follows: (i) Determine the vehicle's Actual Charge-Depleting Range, R cda , separately for FTP-based city and HFET-based highway driving. Adjust these values to represent 5-cycle values as described in 600.115-11, then combine them arithmetically by averaging the two values, weighted 0.55 and 0.45, respectively, and rounding to the nearest whole number. Precondition the vehicle as needed to minimize engine operation for consuming stored fuel vapors in evaporative canisters; for example, you may purge the evaporative canister or time a refueling event to avoid engine starting related to purging the canister. For vehicles that use combined power from the battery and the engine before the battery is fully discharged, also use this procedure to establish an all electric range by determining the distance the vehicle drives before the engine starts, rounded to the nearest mile. You may represent this as a range of values. We may approve adjustments to these procedures if they are necessary to properly characterize a vehicle's all electric range. (ii) Use good engineering judgment to calculate the vehicle's operating distance before the fuel tank is empty when starting with a full fuel tank and a fully charged battery, consistent with the procedure and calculation specified in this paragraph (j), rounded to the nearest 10 miles. (5) For hydrogen fuel cell vehicles, determine the vehicle's driving range in miles by multiplying the combined fuel economy described in paragraph (a) of this section by the vehicle's usable fuel storage capacity (expressed in kilograms of hydrogen), rounded to the nearest whole number. (k) Charge time. For electric vehicles, determine the time it takes to fully charge the battery from a 240 volt power source to the point that the battery meets the manufacturer's end-of-charge criteria, consistent with the procedures specified in SAE J1634 (incorporated by reference in § 600.011) for electric vehicles and in SAE J1711 (incorporated by reference in § 600.011) for plug-in hybrid electric vehicles, as described in § 600.116. This value may be more or less than the 12-hour minimum charging time specified for testing. You must alternatively specify the charge time based on a standard 120 volt power source if the vehicle cannot be charged at the higher voltage. (l) California-specific values. If the Administrator determines that automobiles intended for sale in California are likely to exhibit significant differences in fuel economy or other label values from those intended for sale in other states, the Administrator will compute separate values for each class of automobiles for California and for the other states." 40:40:32.0.1.4.44.4.13.9,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,D,Subpart D—Fuel Economy Labeling,,"§ 600.312-08 Labeling, reporting, and recordkeeping; Administrator reviews.",EPA,,,"[49 FR 13852, Apr. 6, 1984. Redesignated at 76 FR 39558, July 6, 2011]","(a)(1) The manufacturer shall determine label values (general and specific) using the procedures specified in subparts C and D of this part and submit the label values, and the data sufficient to calculate the label values, to the Administrator according to the timetable specified in § 600.313. (2) Except under paragraph (a)(4) of this section, the manufacturer is not required to obtain Administrator approval of label values prior to the introduction of vehicles for sale. (3) The label values that the manufacturer calculates and submits under paragraph (a)(1) of this section shall constitute the EPA fuel economy estimates unless the Administrator determines that they are not calculated according to the procedures specified in subparts C and D of this part. (4) If required by the Administrator, the manufacturer shall obtain Administrator approval of label values prior to affixing labels to vehicles. (5)(i) If at any time during the model year, any label values are determined not to be calculated according to the procedures specified in subparts C and D of this part, the Administrator shall notify the manufacturer in writing. (ii) If the Administrator has sufficient information to enable calculation of the correct label values, this notification shall specify the correct label values which constitute the EPA Fuel Economy Estimates. (iii) If additional information is required, the Administrator shall request such additional information and a recalculation of the label value by the manufacturer. (6) If the Administrator determines revised label values under paragraph (a)(5) of this section are lower than the label values calculated by the manufacturer, the manufacturer shall affix the revised labels to all affected new vehicles which are unsold beginning no later than 15 calendar days after the date of notification by the Administrator. (b)(1) The manufacturer is responsible for affixing vehicle labels that meet the format and content requirements of this subpart. (2) The manufacturer shall retain for examination, at the Administrator's discretion, typical label formats representing all information required on the manufacturer's fuel economy labels. The information shall include the text of all required and voluntary information as well as the size and color of print and paper, spacing, and location of all printed information. Where the fuel economy label is incorporated with the Automobile Information Disclosure Act label, the above requirements pertain to those sections of the label concerning fuel economy labeling information. (3) If the Administrator determines upon examination of record that the label format or content do not meet the requirements of this subpart, the Administrator may: (i) Require the manufacturer to make specific changes in subsequent labels, and (ii) Require such changes to be implemented on a reasonable timetable, but no sooner than 15 days from the date of notification to the manufacturer." 40:40:32.0.1.4.44.5.13.1,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,E,Subpart E—Dealer Availability of Fuel Economy Information,,§ 600.405-08 Dealer requirements.,EPA,,,"[71 FR 77954, Dec. 27, 2006]","(a) Each dealer shall prominently display at each location where new automobiles are offered for sale a copy of the annual Fuel Economy Guide containing the information specified in § 600.407. The Fuel Economy Guide may be made available either in hard copy or electronically via an on-site computer available for prospective purchasers to view and print as desired. The dealer shall provide this information without charge. The dealer will be expected to make this information available as soon as it is received by the dealer, but in no case later than 15 working days after notification is given of its availability. The Department of Energy will annually notify dealers of the availability of the information with instructions on how to obtain it either electronically or in hard copy. (b) The dealer shall display the Fuel Economy Guide, or a notice of where the customer can electronically access the Fuel Economy Guide, in the same manner and in each location used to display brochures describing the automobiles offered for sale by the dealer. The notice shall include a link to the official Web site where this information is contained ( http://www.fueleconomy.gov. ) (c) The dealer shall display the booklet applicable to each model year automobile offered for sale at the location." 40:40:32.0.1.4.44.5.13.2,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,E,Subpart E—Dealer Availability of Fuel Economy Information,,§ 600.407-08 Booklets displayed by dealers.,EPA,,,"[71 FR 77954, Dec. 27, 2006]","(a) Booklets displayed by dealers in order to fulfill the obligations of § 600.405 may be either (1) The printed copy of the annual Fuel Economy Guide published by the Department of Energy, or; (2) Optionally, dealers may display the Fuel Economy Guide on a computer that is linked to the electronic version of the Fuel Economy Guide (available at http://www.fueleconomy.gov ), or; (3) A booklet approved by the Administrator of EPA containing the same information, format, and order as the Fuel Economy Guide published by the Department of Energy. Such a booklet may highlight the dealer's product line by contrasting color of ink or boldface type and may include other supplemental information regarding the dealer's product line subject to approval by the Administrator. (b) A manufacturer's name and logo or a dealer's name and address or both may appear on the back cover of the hard copies of the Fuel Economy Guide." 40:40:32.0.1.4.44.6.13.1,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.502 Definitions.,EPA,,,"[76 FR 39567, July 6, 2011]","The following definitions apply to this subpart in addition to those in § 600.002: (a) The Declared value of imported components shall be: (1) The value at which components are declared by the importer to the U.S. Customs Service at the date of entry into the customs territory of the United States; or (2) With respect to imports into Canada, the declared value of such components as if they were declared as imports into the United States at the date of entry into Canada; or (3) With respect to imports into Mexico, the declared value of such components as if they were declared as imports into the United States at the date of entry into Mexico. (b) Cost of production of a car line shall mean the aggregate of the products of: (1) The average U.S. dealer wholesale price for such car line as computed from each official dealer price list effective during the course of a model year, and (2) The number of automobiles within the car line produced during the part of the model year that the price list was in effect. (c) Equivalent petroleum-based fuel economy value means a number representing the average number of miles traveled by an electric vehicle per gallon of gasoline." 40:40:32.0.1.4.44.6.13.2,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.507-12 Running change data requirements.,EPA,,,"[75 FR 25713, May 7, 2010, as amended at 76 FR 39567, July 6, 2011]","(a) Except as specified in paragraph (d) of this section, the manufacturer shall submit additional running change fuel economy and carbon-related exhaust emissions data as specified in paragraph (b) of this section for any running change approved or implemented under § 86.1842 of this chapter, which: (1) Creates a new base level or, (2) Affects an existing base level by: (i) Adding an axle ratio which is at least 10 percent larger (or, optionally, 10 percent smaller) than the largest axle ratio tested. (ii) Increasing (or, optionally, decreasing) the road-load horsepower for a subconfiguration by 10 percent or more for the individual running change or, when considered cumulatively, since original certification (for each cumulative 10 percent increase using the originally certified road-load horsepower as a base). (iii) Adding a new subconfiguration by increasing (or, optionally, decreasing) the equivalent test weight for any previously tested subconfiguration in the base level. (iv) Revising the calibration of an electric vehicle, fuel cell vehicle, hybrid electric vehicle, plug-in hybrid electric vehicle or other advanced technology vehicle in such a way that the city or highway fuel economy of the vehicle (or the energy consumption of the vehicle, as may be applicable) is expected to become less fuel efficient (or optionally, more fuel efficient) by 4.0 percent or more as compared to the original fuel economy label values for fuel economy and/or energy consumption, as applicable. (b)(1) The additional running change fuel economy and carbon-related exhaust emissions data requirement in paragraph (a) of this section will be determined based on the sales of the vehicle configurations in the created or affected base level(s) as updated at the time of running change approval. (2) Within each newly created base level as specified in paragraph (a)(1) of this section, the manufacturer shall submit data from the highest projected total model year sales subconfiguration within the highest projected total model year sales configuration in the base level. (3) Within each base level affected by a running change as specified in paragraph (a)(2) of this section, fuel economy and carbon-related exhaust emissions data shall be submitted for the vehicle configuration created or affected by the running change which has the highest total model year projected sales. The test vehicle shall be of the subconfiguration created by the running change which has the highest projected total model year sales within the applicable vehicle configuration. (c) The manufacturer shall submit the fuel economy data required by this section to the Administrator in accordance with § 600.314. (d) For those model types created under § 600.208-12(a)(2), the manufacturer shall submit fuel economy and carbon-related exhaust emissions data for each subconfiguration added by a running change." 40:40:32.0.1.4.44.6.13.3,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.509-12 Voluntary submission of additional data.,EPA,,,"[75 FR 25713, May 7, 2010]","(a) The manufacturer may optionally submit data in addition to the data required by the Administrator. (b) Additional fuel economy and carbon-related exhaust emissions data may be submitted by the manufacturer for any vehicle configuration which is to be tested as required in § 600.507 or for which fuel economy and carbon-related exhaust emissions data were previously submitted under paragraph (c) of this section. (c) Within a base level, additional fuel economy and carbon-related exhaust emissions data may be submitted by the manufacturer for any vehicle configuration which is not required to be tested by § 600.507." 40:40:32.0.1.4.44.6.13.4,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.510-12 Calculation of average fuel economy and average carbon-related exhaust emissions.,EPA,,,"[75 FR 25714, May 7, 2010, as amended at 76 FR 39567, July 6, 2011; 77 FR 63184, Oct. 15, 2012; 81 FR 74003, Dec. 27, 2016; 85 FR 25272, Apr. 30, 2020; 85 FR 53679, Aug. 31, 2020; 86 FR 74526, Dec. 30, 2021; 88 FR 4484, Jan. 24, 2023]","(a)(1) Average fuel economy will be calculated to the nearest 0.1 mpg for the categories of automobiles identified in this section, and the results of such calculations will be reported to the Secretary of Transportation for use in determining compliance with the applicable fuel economy standards. (i) An average fuel economy calculation will be made for the category of passenger automobiles as determined by the Secretary of Transportation. For example, categories may include, but are not limited to domestically manufactured and/or non-domestically manufactured passenger automobiles as determined by the Secretary of Transportation. (ii) [Reserved] (iii) An average fuel economy calculation will be made for the category of trucks as determined by the Secretary of Transportation. For example, categories may include, but are not limited to domestically manufactured trucks, non-domestically manufactured trucks, light-duty trucks, medium-duty passenger vehicles, and/or heavy-duty trucks as determined by the Secretary of Transportation. (iv) [Reserved] (2) Average carbon-related exhaust emissions will be calculated to the nearest one gram per mile for the categories of automobiles identified in this section, and the results of such calculations will be reported to the Administrator for use in determining compliance with the applicable CO 2 emission standards. (i) An average carbon-related exhaust emissions calculation will be made for passenger automobiles. (ii) An average carbon-related exhaust emissions calculation will be made for light trucks. (b) For the purpose of calculating average fuel economy under paragraph (c) of this section and for the purpose of calculating average carbon-related exhaust emissions under paragraph (j) of this section: (1) All fuel economy and carbon-related exhaust emissions data submitted in accordance with § 600.006(e) or § 600.512(c) shall be used. (2) The combined city/highway fuel economy and carbon-related exhaust emission values will be calculated for each model type in accordance with § 600.208 except that: (i) Separate fuel economy values will be calculated for model types and base levels associated with car lines for each category of passenger automobiles and light trucks as determined by the Secretary of Transportation pursuant to paragraph (a)(1) of this section. (ii) Total model year production data, as required by this subpart, will be used instead of sales projections; (iii) [Reserved] (iv) The fuel economy value will be rounded to the nearest 0.1 mpg; (v) The carbon-related exhaust emission value will be rounded to the nearest gram per mile; and (vi) At the manufacturer's option, those vehicle configurations that are self-compensating to altitude changes may be separated by sales into high-altitude sales categories and low-altitude sales categories. These separate sales categories may then be treated (only for the purpose of this section) as separate configurations in accordance with the procedure of § 600.208-12(a)(4)(ii). (3) The fuel economy and carbon-related exhaust emission values for each vehicle configuration are the combined fuel economy and carbon-related exhaust emissions calculated according to § 600.206-12(a)(3) except that: (i) Separate fuel economy values will be calculated for vehicle configurations associated with car lines for each category of passenger automobiles and light trucks as determined by the Secretary of Transportation pursuant to paragraph (a)(1) of this section. (ii) Total model year production data, as required by this subpart will be used instead of sales projections; and (iii) [Reserved] (4) Emergency vehicles may be excluded from the fleet average carbon-related exhaust emission calculations described in paragraph (j) of this section. The manufacturer should notify the Administrator that they are making such an election in the model year reports required under § 600.512 of this chapter. Such vehicles should be excluded from both the calculation of the fleet average standard for a manufacturer under 40 CFR 86.1818-12(c)(4) and from the calculation of the fleet average carbon-related exhaust emissions in paragraph (j) of this section. (c)(1) Average fuel economy shall be calculated as follows: (i) Except as allowed in paragraph (d) of this section, the average fuel economy for the model years before 2017 will be calculated individually for each category identified in paragraph (a)(1) of this according to the provisions of paragraph (c)(2) of this section. (ii) Except as permitted in paragraph (d) of this section, the average fuel economy for the 2017 and later model years will be calculated individually for each category identified in paragraph (a)(1) of this section using the following equation: Where: Average MPG = the fleet average fuel economy for a category of vehicles; MPG = the average fuel economy for a category of vehicles determined according to paragraph (h) of this section; FCIV AC = Air conditioning fuel economy credits for a category of vehicles, in gallons per mile, determined according to paragraph (c)(3)(i) of this section; FCIV OC = Off-cycle technology fuel economy credits for a category of vehicles, in gallons per mile, determined according to paragraph (c)(3)(ii) of this section; and FCIV PU = Pickup truck fuel economy credits for the light truck category, in gallons per mile, determined according to paragraph (c)(3)(iii) of this section. Where: Average MPG = the fleet average fuel economy for a category of vehicles; MPG = the average fuel economy for a category of vehicles determined according to paragraph (h) of this section; FCIV AC = Air conditioning fuel economy credits for a category of vehicles, in gallons per mile, determined according to paragraph (c)(3)(i) of this section; FCIV OC = Off-cycle technology fuel economy credits for a category of vehicles, in gallons per mile, determined according to paragraph (c)(3)(ii) of this section; and FCIV PU = Pickup truck fuel economy credits for the light truck category, in gallons per mile, determined according to paragraph (c)(3)(iii) of this section. (2) Divide the total production volume of that category of automobiles by a sum of terms, each of which corresponds to a model type within that category of automobiles and is a fraction determined by dividing the number of automobiles of that model type produced by the manufacturer in the model year by: (i) For gasoline-fueled and diesel-fueled model types, the fuel economy calculated for that model type in accordance with paragraph (b)(2) of this section; or (ii) For alcohol-fueled model types, the fuel economy value calculated for that model type in accordance with paragraph (b)(2) of this section divided by 0.15 and rounded to the nearest 0.1 mpg; or (iii) For natural gas-fueled model types, the fuel economy value calculated for that model type in accordance with paragraph (b)(2) of this section divided by 0.15 and rounded to the nearest 0.1 mpg; or (iv) For alcohol dual fuel model types, for model years 1993 through 2019, the harmonic average of the following two terms; the result rounded to the nearest 0.1 mpg: (A) The combined model type fuel economy value for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i); and (B) The combined model type fuel economy value for operation on alcohol fuel as determined in § 600.208-12(b)(5)(ii) divided by 0.15 provided the requirements of paragraph (g) of this section are met; or (v) For alcohol dual fuel model types, for model years after 2019, the combined model type fuel economy determined according to the following equation and rounded to the nearest 0.1 mpg: Where: F = 0.00 unless otherwise approved by the Administrator according to the provisions of paragraph (k) of this section; MPG A = The combined model type fuel economy for operation on alcohol fuel as determined in § 600.208-12(b)(5)(ii) divided by 0.15 provided the requirements of paragraph (g) of this section are met; and MPG G = The combined model type fuel economy for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). Where: F = 0.00 unless otherwise approved by the Administrator according to the provisions of paragraph (k) of this section; MPG A = The combined model type fuel economy for operation on alcohol fuel as determined in § 600.208-12(b)(5)(ii) divided by 0.15 provided the requirements of paragraph (g) of this section are met; and MPG G = The combined model type fuel economy for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). (vi) For natural gas dual fuel model types, for model years 1993 through 2016, and optionally for 2021 and later model years, the harmonic average of the following two terms; the result rounded to the nearest 0.1 mpg: (A) The combined model type fuel economy value for operation on gasoline or diesel as determined in § 600.208-12(b)(5)(i); and (B) The combined model type fuel economy value for operation on natural gas as determined in § 600.208-12(b)(5)(ii) divided by 0.15 provided the requirements of paragraph (g) of this section are met; or (vii) This paragraph (c)(2)(vii) applies to model year 2017 through 2020 natural gas dual fuel model types. Model year 2021 and later natural gas dual fuel model types may use the provisions of paragraph (c)(2)(vi) of this section or this paragraph (c)(2)(vii). (A) For natural gas dual fuel model types, for model years after 2016, the combined model type fuel economy determined according to the following formula and rounded to the nearest 0.1 mpg: Where: MPG CNG = The combined model type fuel economy for operation on natural gas as determined in § 600.208-12(b)(5)(ii) divided by 0.15 provided the requirements of paragraph (g) of this section are met; and MPG G = The combined model type fuel economy for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). UF = A Utility Factor (UF) value selected from the following table based on the driving range of the vehicle while operating on natural gas, except for natural gas dual fuel vehicles that do not meet the criteria in paragraph (c)(2)(vii)(B) the Utility Factor shall be 0.5. Determine the vehicle's driving range in miles by multiplying the combined fuel economy as determined in § 600.208-12(b)(5)(ii) by the vehicle's usable fuel storage capacity (as defined at § 600.002 and expressed in gasoline gallon equivalents), and rounding to the nearest 10 miles. Where: MPG CNG = The combined model type fuel economy for operation on natural gas as determined in § 600.208-12(b)(5)(ii) divided by 0.15 provided the requirements of paragraph (g) of this section are met; and MPG G = The combined model type fuel economy for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). UF = A Utility Factor (UF) value selected from the following table based on the driving range of the vehicle while operating on natural gas, except for natural gas dual fuel vehicles that do not meet the criteria in paragraph (c)(2)(vii)(B) the Utility Factor shall be 0.5. Determine the vehicle's driving range in miles by multiplying the combined fuel economy as determined in § 600.208-12(b)(5)(ii) by the vehicle's usable fuel storage capacity (as defined at § 600.002 and expressed in gasoline gallon equivalents), and rounding to the nearest 10 miles. (B) Model year 2017 through 2020 natural gas dual fuel model types must meet the following criteria to qualify for use of a Utility Factor greater than 0.5: ( 1 ) The driving range using natural gas must be at least two times the driving range using gasoline. ( 2 ) The natural gas dual fuel vehicle must be designed such that gasoline is used only when the natural gas tank is effectively empty, except for limited use of gasoline that may be required to initiate combustion. (3) Fuel consumption improvement. Calculate the separate air conditioning, off-cycle, and pickup truck fuel consumption improvement as follows: (i) Air conditioning fuel consumption improvement values are calculated separately for each category identified in paragraph (a)(1) of this section using the following equation: Where: FCIV AC = the fleet production-weighted total value of air conditioning efficiency credits (fuel consumption improvement value) for all air conditioning systems in the applicable fleet, expressed in gallons per mile; ACCredit = the total of all air conditioning efficiency credits for the applicable vehicle category, in megagrams, from 40 CFR 86.1868-12(c), and rounded to the nearest whole number; VLM = vehicle lifetime miles, which for passenger automobiles shall be 195,264 and for light trucks shall be 225,865; and Production = the total production volume for the applicable category of vehicles. Where: FCIV AC = the fleet production-weighted total value of air conditioning efficiency credits (fuel consumption improvement value) for all air conditioning systems in the applicable fleet, expressed in gallons per mile; ACCredit = the total of all air conditioning efficiency credits for the applicable vehicle category, in megagrams, from 40 CFR 86.1868-12(c), and rounded to the nearest whole number; VLM = vehicle lifetime miles, which for passenger automobiles shall be 195,264 and for light trucks shall be 225,865; and Production = the total production volume for the applicable category of vehicles. (ii) Off-cycle technology fuel consumption improvement values are calculated separately for each category identified in paragraph (a)(1) of this section using the following equation: Where: FCIV OC = the fleet production-weighted total value of off-cycle technology credits (fuel consumption improvement value) for all off-cycle technologies in the applicable fleet, expressed in gallons per mile; OCCredit = the total of all off-cycle technology credits for the applicable vehicle category, in megagrams, from 40 CFR 86.1869-12(e), and rounded to the nearest whole number; VLM = vehicle lifetime miles, which for passenger automobiles shall be 195,264 and for light trucks shall be 225,865; and Production = the total production volume for the applicable category of vehicles. Where: FCIV OC = the fleet production-weighted total value of off-cycle technology credits (fuel consumption improvement value) for all off-cycle technologies in the applicable fleet, expressed in gallons per mile; OCCredit = the total of all off-cycle technology credits for the applicable vehicle category, in megagrams, from 40 CFR 86.1869-12(e), and rounded to the nearest whole number; VLM = vehicle lifetime miles, which for passenger automobiles shall be 195,264 and for light trucks shall be 225,865; and Production = the total production volume for the applicable category of vehicles. (iii) Full size pickup truck fuel consumption improvement values are calculated for the light truck category identified in paragraph (a)(1) of this section using the following equation: Where: FCIV PU = the fleet production-weighted total value of full size pickup truck credits (fuel consumption improvement value) for the light truck fleet, expressed in gallons per mile; PUCredit = the total of all full size pickup truck credits, in megagrams, from 40 CFR 86.1870-12(c), and rounded to the nearest whole number; and Production = the total production volume for the light truck category. Where: FCIV PU = the fleet production-weighted total value of full size pickup truck credits (fuel consumption improvement value) for the light truck fleet, expressed in gallons per mile; PUCredit = the total of all full size pickup truck credits, in megagrams, from 40 CFR 86.1870-12(c), and rounded to the nearest whole number; and Production = the total production volume for the light truck category. (d) The Administrator may approve alternative calculation methods if they are part of an approved credit plan under the provisions of 15 U.S.C. 2003. (e) For passenger automobile categories identified in paragraph (a)(1) of this section, the average fuel economy calculated in accordance with paragraph (c) of this section shall be adjusted using the following equation: AFE adj = AFE[((0.55 × a × c) + (0.45 × c) + (0.5556 × a) + 0.4487)/((0.55 × a) + 0.45)] + IW Where: AFE = Average combined fuel economy as calculated in paragraph (c)(2) of this section, rounded to the nearest 0.0001 mpg; AFE = Average combined fuel economy as calculated in paragraph (c) of this section, rounded to the nearest 0.0001 mpg; a = Sales-weight average (rounded to the nearest 0.0001 mpg) of all model type highway fuel economy values (rounded to the nearest 0.1 mpg) divided by the sales-weighted average (rounded to the nearest 0.0001 mpg) of all model type city fuel economy values (rounded to the nearest 0.1 mpg). The quotient shall be rounded to 4 decimal places. These average fuel economies shall be determined using the methodology of paragraph (c) of this section. c = 0.0014; IW = (9.2917 × 10 −3 × SF 3IWC × FE 3IWC ) − (3.5123 × 10 −3 × SF 4ETW × FE 4IWC ). Note: Any calculated value of IW less than zero shall be set equal to zero. SF 3IWC = The 3000 lb. inertia weight class sales divided by total sales. The quotient shall be rounded to 4 decimal places. SF 4ETW = The 4000 lb. equivalent test weight category sales divided by total sales. The quotient shall be rounded to 4 decimal places. FE 4IWC = The sales-weighted average combined fuel economy of all 3000 lb. inertia weight class base levels in the compliance category. Round the result to the nearest 0.0001 mpg. FE 4IWC = The sales-weighted average combined fuel economy of all 4000 lb. inertia weight class base levels in the compliance category. Round the result to the nearest 0.0001 mpg. Where: AFE = Average combined fuel economy as calculated in paragraph (c)(2) of this section, rounded to the nearest 0.0001 mpg; AFE = Average combined fuel economy as calculated in paragraph (c) of this section, rounded to the nearest 0.0001 mpg; a = Sales-weight average (rounded to the nearest 0.0001 mpg) of all model type highway fuel economy values (rounded to the nearest 0.1 mpg) divided by the sales-weighted average (rounded to the nearest 0.0001 mpg) of all model type city fuel economy values (rounded to the nearest 0.1 mpg). The quotient shall be rounded to 4 decimal places. These average fuel economies shall be determined using the methodology of paragraph (c) of this section. c = 0.0014; IW = (9.2917 × 10 −3 × SF 3IWC × FE 3IWC ) − (3.5123 × 10 −3 × SF 4ETW × FE 4IWC ). Any calculated value of IW less than zero shall be set equal to zero. SF 3IWC = The 3000 lb. inertia weight class sales divided by total sales. The quotient shall be rounded to 4 decimal places. SF 4ETW = The 4000 lb. equivalent test weight category sales divided by total sales. The quotient shall be rounded to 4 decimal places. FE 4IWC = The sales-weighted average combined fuel economy of all 3000 lb. inertia weight class base levels in the compliance category. Round the result to the nearest 0.0001 mpg. FE 4IWC = The sales-weighted average combined fuel economy of all 4000 lb. inertia weight class base levels in the compliance category. Round the result to the nearest 0.0001 mpg. (f) The Administrator shall calculate and apply additional average fuel economy adjustments if, after notice and opportunity for comment, the Administrator determines that, as a result of test procedure changes not previously considered, such correction is necessary to yield fuel economy test results that are comparable to those obtained under the 1975 test procedures. In making such determinations, the Administrator must find that: (1) A directional change in measured fuel economy of an average vehicle can be predicted from a revision to the test procedures; (2) The magnitude of the change in measured fuel economy for any vehicle or fleet of vehicles caused by a revision to the test procedures is quantifiable from theoretical calculations or best available test data; (3) The impact of a change on average fuel economy is not due to eliminating the ability of manufacturers to take advantage of flexibility within the existing test procedures to gain measured improvements in fuel economy which are not the result of actual improvements in the fuel economy of production vehicles; (4) The impact of a change on average fuel economy is not solely due to a greater ability of manufacturers to reflect in average fuel economy those design changes expected to have comparable effects on in-use fuel economy; (5) The test procedure change is required by EPA or is a change initiated by EPA in its laboratory and is not a change implemented solely by a manufacturer in its own laboratory. (g)(1) Dual fuel automobiles must provide equal or greater energy efficiency while operating on the alternative fuel as while operating on gasoline or diesel fuel to obtain the CAFE credit determined in paragraphs (c)(2)(iv) and (v) of this section or to obtain the carbon-related exhaust emissions credit determined in paragraphs (j)(2)(ii) and (iii) of this section. The following equation must hold true: E alt /E pet ≥ 1 Where: E alt = [FE alt /(NHV alt × D alt )] × 10 6 = energy efficiency while operating on alternative fuel rounded to the nearest 0.01 miles/million BTU. E pet = [FE pet /(NHV pet × D pet )] × 10 6 = energy efficiency while operating on gasoline or diesel (petroleum) fuel rounded to the nearest 0.01 miles/million BTU. FE alt is the fuel economy [miles/gallon for liquid fuels or miles/100 standard cubic feet for gaseous fuels] while operated on the alternative fuel as determined in § 600.113-12(a) and (b). FE pet is the fuel economy [miles/gallon] while operated on petroleum fuel (gasoline or diesel) as determined in § 600.113-12(a) and (b). NHV alt is the net (lower) heating value [BTU/lb] of the alternative fuel. NHV pet is the net (lower) heating value [BTU/lb] of the petroleum fuel. D alt is the density [lb/gallon for liquid fuels or lb/100 standard cubic feet for gaseous fuels] of the alternative fuel. D pet is the density [lb/gallon] of the petroleum fuel. Where: E alt = [FE alt /(NHV alt × D alt )] × 10 6 = energy efficiency while operating on alternative fuel rounded to the nearest 0.01 miles/million BTU. E pet = [FE pet /(NHV pet × D pet )] × 10 6 = energy efficiency while operating on gasoline or diesel (petroleum) fuel rounded to the nearest 0.01 miles/million BTU. FE alt is the fuel economy [miles/gallon for liquid fuels or miles/100 standard cubic feet for gaseous fuels] while operated on the alternative fuel as determined in § 600.113-12(a) and (b). FE pet is the fuel economy [miles/gallon] while operated on petroleum fuel (gasoline or diesel) as determined in § 600.113-12(a) and (b). NHV alt is the net (lower) heating value [BTU/lb] of the alternative fuel. NHV pet is the net (lower) heating value [BTU/lb] of the petroleum fuel. D alt is the density [lb/gallon for liquid fuels or lb/100 standard cubic feet for gaseous fuels] of the alternative fuel. D pet is the density [lb/gallon] of the petroleum fuel. (i) The equation must hold true for both the FTP city and HFET highway fuel economy values for each test of each test vehicle. (ii)(A) The net heating value for alcohol fuels shall be premeasured using a test method which has been approved in advance by the Administrator. (B) The density for alcohol fuels shall be premeasured using ASTM D 1298 (incorporated by reference at § 600.011). (iii) The net heating value and density of gasoline are to be determined by the manufacturer in accordance with § 600.113. (2) [Reserved] (3) Dual fuel passenger automobiles manufactured during model years 1993 through 2019 must meet the minimum driving range requirements established by the Secretary of Transportation (49 CFR part 538) to obtain the CAFE credit determined in paragraphs (c)(2)(iv) and (v) of this section. (h) The increase in average fuel economy determined in paragraph (c) of this section attributable to dual fueled automobiles is subject to a maximum value through model year 2019 that applies separately to each category of automobile specified in paragraph (a)(1) of this section. The increase in average fuel economy attributable to vehicles fueled by electricity or, for model years 2016 and later, by compressed natural gas, is not subject to a maximum value. The increase in average fuel economy attributable to alcohol dual fuel model types calculated under paragraph (c)(2)(v) of this section is also not subject to a maximum value. The following maximum values apply under this paragraph (h): (1) The Administrator shall calculate the increase in average fuel economy to determine if the maximum increase provided in this paragraph (h) has been reached. The Administrator shall calculate the increase in average fuel economy for each category of automobiles specified in paragraph (a)(1) of this section by subtracting the average fuel economy values calculated in accordance with this section, assuming all alcohol dual fueled automobiles subject to the provisions of paragraph (c)(2)(iv) of this section are operated exclusively on gasoline (or diesel fuel), from the average fuel economy values determined in paragraph (c) of this section. The difference is limited to the maximum increase specified in this paragraph (h). (2) [Reserved] (i) For model years 2012 through 2015, and for each category of automobile identified in paragraph (a)(1) of this section, the maximum decrease in average carbon-related exhaust emissions determined in paragraph (j) of this section attributable to alcohol dual fuel automobiles and natural gas dual fuel automobiles shall be calculated using the following formula, and rounded to the nearest tenth of a gram per mile: Where: FltAvg = The fleet average CREE value in grams per mile, rounded to the nearest whole number, for passenger automobiles or light trucks determined for the applicable model year according to paragraph (j) of this section, except by assuming all alcohol dual fuel and natural gas dual fuel automobiles are operated exclusively on gasoline (or diesel) fuel. For the purposes of these calculations, the values for natural gas dual fuel automobiles using the optional Utility Factor approach in paragraph (j)(2)(vii) of this section shall not be the gasoline CREE values, but the CREE values determined in paragraph (j)(2)(vii) of this section. MPG MAX = The maximum increase in miles per gallon determined for the appropriate model year in paragraph (h) of this section. Where: FltAvg = The fleet average CREE value in grams per mile, rounded to the nearest whole number, for passenger automobiles or light trucks determined for the applicable model year according to paragraph (j) of this section, except by assuming all alcohol dual fuel and natural gas dual fuel automobiles are operated exclusively on gasoline (or diesel) fuel. For the purposes of these calculations, the values for natural gas dual fuel automobiles using the optional Utility Factor approach in paragraph (j)(2)(vii) of this section shall not be the gasoline CREE values, but the CREE values determined in paragraph (j)(2)(vii) of this section. MPG MAX = The maximum increase in miles per gallon determined for the appropriate model year in paragraph (h) of this section. (1) The Administrator shall calculate the decrease in average carbon-related exhaust emissions to determine if the maximum decrease provided in this paragraph (i) has been reached. The Administrator shall calculate the average carbon-related exhaust emissions for each category of automobiles specified in paragraph (a) of this section by subtracting the average carbon-related exhaust emission values determined in paragraph (j) of this section from the average carbon-related exhaust emission values calculated in accordance with this section by assuming all alcohol dual fuel and natural gas dual fuel automobiles are operated exclusively on gasoline (or diesel) fuel. For the purposes of these calculations, the values for natural gas dual fuel automobiles using the optional Utility Factor approach in paragraph (j)(2)(vii) of this section shall not be the gasoline CREE values, but the CREE values determined in paragraph (j)(2)(vii) of this section. The difference is limited to the maximum decrease specified in paragraph (i) of this section. (2) [Reserved] (j) The average carbon-related exhaust emissions will be calculated individually for each category identified in paragraph (a)(1) of this section as follows: (1) Divide the total production volume of that category of automobiles into: (2) A sum of terms, each of which corresponds to a model type within that category of automobiles and is a product determined by multiplying the number of automobiles of that model type produced by the manufacturer in the model year by: (i) For gasoline-fueled and diesel-fueled model types, the carbon-related exhaust emissions value calculated for that model type in accordance with paragraph (b)(2) of this section; or (ii)(A) For alcohol-fueled model types, for model years 2012 through 2015, the carbon-related exhaust emissions value calculated for that model type in accordance with paragraph (b)(2) of this section multiplied by 0.15 and rounded to the nearest gram per mile, except that manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter must perform this calculation such that N 2 O and CH 4 values are not multiplied by 0.15; or (B) For alcohol-fueled model types, for model years 2016 and later, the carbon-related exhaust emissions value calculated for that model type in accordance with paragraph (b)(2) of this section; or (iii)(A) For natural gas-fueled model types, for model years 2012 through 2015, the carbon-related exhaust emissions value calculated for that model type in accordance with paragraph (b)(2) of this section multiplied by 0.15 and rounded to the nearest gram per mile, except that manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter must perform this calculation such that N 2 O and CH 4 values are not multiplied by 0.15; or (B) For natural gas-fueled model types, for model years 2016 and later, the carbon-related exhaust emissions value calculated for that model type in accordance with paragraph (b)(2) of this section; or (iv) For alcohol dual fuel model types, for model years 2012 through 2015, the arithmetic average of the following two terms, the result rounded to the nearest gram per mile: (A) The combined model type carbon-related exhaust emissions value for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i); and (B) The combined model type carbon-related exhaust emissions value for operation on alcohol fuel as determined in § 600.208-12(b)(5)(ii) multiplied by 0.15 provided the requirements of paragraph (g) of this section are met, except that manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter must perform this calculation such that N 2 O and CH 4 values are not multiplied by 0.15; or (v) For natural gas dual fuel model types, for model years 2012 through 2015, the arithmetic average of the following two terms; the result rounded to the nearest gram per mile: (A) The combined model type carbon-related exhaust emissions value for operation on gasoline or diesel as determined in § 600.208-12(b)(5)(i); and (B) The combined model type carbon-related exhaust emissions value for operation on natural gas as determined in § 600.208-12(b)(5)(ii) multiplied by 0.15 provided the requirements of paragraph (g) of this section are met, except that manufacturers complying with the fleet averaging option for N 2 O and CH 4 as allowed under § 86.1818 of this chapter must perform this calculation such that N 2 O and CH 4 values are not multiplied by 0.15. (vi) For alcohol dual fuel model types, for model years 2016 and later, the combined model type carbon-related exhaust emissions value determined according to the following formula and rounded to the nearest gram per mile: CREE = (F × CREE alt ) + ((1 − F) × CREE gas ) Where: F = 0.00 unless otherwise approved by the Administrator according to the provisions of paragraph (k) of this section; CREE alt = The combined model type carbon-related exhaust emissions value for operation on alcohol fuel as determined in § 600.208-12(b)(5)(ii); and CREE gas = The combined model type carbon-related exhaust emissions value for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). Where: F = 0.00 unless otherwise approved by the Administrator according to the provisions of paragraph (k) of this section; CREE alt = The combined model type carbon-related exhaust emissions value for operation on alcohol fuel as determined in § 600.208-12(b)(5)(ii); and CREE gas = The combined model type carbon-related exhaust emissions value for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). (vii)(A) This paragraph (j)(2)(vii) applies to model year 2016 and later natural gas dual fuel model types. Model year 2021 and later natural gas dual fuel model types may use a utility factor of 0.5 or the utility factor prescribed in this paragraph (j)(2)(vii). Where: CREE CNG = The combined model type carbon-related exhaust emissions value for operation on natural gas as determined in § 600.208-12(b)(5)(ii); and CREE GAS = The combined model type carbon-related exhaust emissions value for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). UF = A Utility Factor (UF) value selected from the following table based on the driving range of the vehicle while operating on natural gas, except for natural gas dual fuel vehicles that do not meet the criteria in paragraph (j)(2)(vii)(B) the Utility Factor shall be 0.5. Determine the vehicle's driving range in miles by multiplying the combined fuel economy as determined in § 600.208-12(b)(5)(ii) by the vehicle's usable fuel storage capacity (as defined at § 600.002 and expressed in gasoline gallon equivalents), and rounding to the nearest 10 miles. Where: CREE CNG = The combined model type carbon-related exhaust emissions value for operation on natural gas as determined in § 600.208-12(b)(5)(ii); and CREE GAS = The combined model type carbon-related exhaust emissions value for operation on gasoline or diesel fuel as determined in § 600.208-12(b)(5)(i). UF = A Utility Factor (UF) value selected from the following table based on the driving range of the vehicle while operating on natural gas, except for natural gas dual fuel vehicles that do not meet the criteria in paragraph (j)(2)(vii)(B) the Utility Factor shall be 0.5. Determine the vehicle's driving range in miles by multiplying the combined fuel economy as determined in § 600.208-12(b)(5)(ii) by the vehicle's usable fuel storage capacity (as defined at § 600.002 and expressed in gasoline gallon equivalents), and rounding to the nearest 10 miles. (B) Model year 2016 through 2020 natural gas dual fuel model types must meet the following criteria to qualify for use of a Utility Factor greater than 0.5: ( 1 ) The driving range using natural gas must be at least two times the driving range using gasoline. ( 2 ) The natural gas dual fuel vehicle must be designed such that gasoline is used only when the natural gas tank is effectively empty, except for limited use of gasoline that may be required to initiate combustion. (k) Alternative in-use weighting factors for dual fuel model types. Using one of the methods in either paragraph (k)(1) or (2) of this section, manufacturers may request the use of alternative values for the weighting factor F in the equations in paragraphs (j)(2)(vi) and (vii) of this section. Unless otherwise approved by the Administrator, the manufacturer must use the value of F that is in effect in paragraphs (j)(2)(vi) and (vii) of this section. (1) Upon written request from a manufacturer, the Administrator will determine and publish by written guidance an appropriate value of F for each requested alternative fuel based on the Administrator's assessment of real-world use of the alternative fuel. Such published values would be available for any manufacturer to use. The Administrator will periodically update these values upon written request from a manufacturer. (2) The manufacturer may optionally submit to the Administrator its own demonstration regarding the real-world use of the alternative fuel in their vehicles and its own estimate of the appropriate value of F in the equations in paragraphs (j)(2)(vi) and (vii) of this section. Depending on the nature of the analytical approach, the manufacturer could provide estimates of F that are model type specific or that are generally applicable to the manufacturer's dual fuel fleet. The manufacturer's analysis could include use of data gathered from on-board sensors and computers, from dual fuel vehicles in fleets that are centrally fueled, or from other sources. The analysis must be based on sound statistical methodology and must account for analytical uncertainty. Any approval by the Administrator will pertain to the use of values of F for the model types specified by the manufacturer." 40:40:32.0.1.4.44.6.13.5,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.511-08 Determination of domestic production.,EPA,,,"[42 FR 45662, Sept. 12, 1977, as amended at 43 FR 39376, Sept. 5, 1978; 59 FR 679, Jan. 6, 1994; 59 FR 33914, July 1, 1994; 74 FR 61554, Nov. 25, 2009. Redesignated at 76 FR 39569, July 6, 2011]","(a) Except with advance approval of the Administrator, an automobile shall be considered domestically produced in any model year if it is included within a domestically produced car line (car line includes station wagons for purposes of this paragraph), unless the assembly of such automobile is completed in Canada or Mexico and such automobile is not imported into the United States prior to the expiration of 30 days following the end of the model year. For purposes of this paragraph a car line will be considered domestically produced if the following ratio is less than 0.25: (1) The sum of the declared value, as defined in § 600.502, of all of the imported components installed or included on automobiles produced within such a car line within a given model year plus the cost of transportation and insuring such components to the United States port of entry, the Mexican port of entry (when paragraph (b)(3) of this section applies), or the Canadian port of entry but exclusive of any customs duty, divided by (2) The cost of production, as defined in § 600.502, of automobiles within such car line. (b) For the purposes of calculations under this subpart with respect to automobiles manufactured during any model year, (1) An average exchange rate for the country of origin of each imported component shall be used that is calculated by taking the mean of the exchange rates in effect at the end of each quarter set by the Federal Reserve Bank of New York for twelve calendar quarters prior to and including the calendar quarter ending one year prior to the date that the manufacturer submits the calculation of the preliminary average for such model year. Such rate, once calculated, shall be in effect for the duration of the model year. Upon petition of a manufacturer, the Administrator may permit the use of a different exchange rate where appropriate and necessary. (2) For automobiles for which paragraph (b)(3) of this section does not apply pursuant to the schedule in paragraph (b)(4), components shall be considered imported unless they are either: (i) Wholly the growth, product, or manufacture of the United States and/or Canada, or (ii) Substantially transformed in the United States or Canada into a new and different article of commerce. (3) For automobiles for which this paragraph applies pursuant to the schedule in paragraph (b)(4) of this section, components shall be considered imported unless they are either: (i) Wholly the growth, product, or manufacture of the United States and/or Canada and/or Mexico, or (ii) Substantially transformed in the United States and/or Canada and/or Mexico into a new and different article of commerce. (4) Paragraphs (b)(4) (i) through (v) of this section set forth the schedule according to which paragraph (b)(3) of this section applies for all automobiles manufactured by a manufacturer and sold in the United States, wherever assembled. (i) With respect to a manufacturer that initiated the assembly of automobiles in Mexico before model year 1992, the manufacturer may elect, at any time between January 1, 1997, and January 1, 2004, to have paragraph (b)(3) of this section apply to all automobiles it manufactures, beginning with the model year commencing after the date of such election. (ii) With respect to a manufacturer initiating the assembly of automobiles in Mexico after model year 1991, paragraph (b)(3) of this section shall apply to all automobiles it manufactures, beginning with the model year commencing after January 1, 1994, or the model year commencing after the date that the manufacturer initiates the assembly of automobiles in Mexico, whichever is later. (iii) With respect to a manufacturer not described by paragraph (b)(4) (i) or (ii) of this section assembling automobiles in the United States or Canada but not in Mexico, the manufacturer may elect, at any time between January 1, 1997, and January 1, 2004, to have paragraph (b)(3) of this section apply to all automobiles it manufactures, beginning with the model year commencing after the date of such election, except that if such manufacturer initiates the assembly of automobiles in Mexico before making such election, this paragraph shall not apply, and the manufacturer shall be subject to paragraph (b)(4)(ii) of this section. (iv) With respect to a manufacturer not assembling automobiles in the United States, Canada, or Mexico, paragraph (b)(3) of this section shall apply to all automobiles it manufactures, beginning with the model year commencing after January 1, 1994. (v) With respect to a manufacturer authorized to make an election under paragraph (b)(4) (i) or (iii) of this section which has not made that election within the specified period, paragraph (b)(3) of this section shall apply to all automobiles it manufactures, beginning with the model year commencing after January 1, 2004. (5) All elections under paragraph (b)(4) of this section shall be made in accordance with the procedures established by the Secretary of Transportation pursuant to 49 U.S.C. 32904(b)(3)(C). (c) If it is determined by the Administrator at some date later than the date of entry that the declared value of such imported components did not represent fair market value at the date of entry, through U.S. Bureau of Customs appraisals, the Administrator may review the determination made pursuant to paragraph (a) of this section as to whether the pertinent car lines which utilize such components were correctly included within the manufaturer's domestically-produced or foreign-produced fleets. If such a determination was in error due to misrepresentation of the valuation of imported components at the date of entry, the Administrator may recalculate the manufacturer's average for the affected model year, according to § 600.510, to reflect the correct valuation of such imported components in each affected car line. (d)-(e) [Reserved]" 40:40:32.0.1.4.44.6.13.6,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.512-12 Model year report.,EPA,,,"[75 FR 25717, May 7, 2010, as amended at 76 FR 39569, July 6, 2011; 88 FR 4484, Jan. 24, 2023]","(a) For each model year, the manufacturer shall submit to the Administrator a report, known as the model year report, containing all information necessary for the calculation of the manufacturer's average fuel economy and all information necessary for the calculation of the manufacturer's average carbon-related exhaust emissions. (1) The results of the manufacturer calculations and summary information of model type fuel economy values which are contained in the average fuel economy calculation shall also be submitted to the Secretary of the Department of Transportation, National Highway and Traffic Safety Administration. (2) The results of the manufacturer calculations and summary information of model type carbon-related exhaust emission values which are contained in the average calculation shall be submitted to the Administrator. (3) Separate reports shall be submitted for passenger automobiles and light trucks (as identified in § 600.510-12). (b) The model year report shall be in writing, signed by the authorized representative of the manufacturer and shall be submitted no later than May 1 following the end of the model year. A manufacturer may request an extension for submitting the model year report if that is needed to provide all additional required data as determined in § 600.507-12. The request must clearly indicate the circumstances necessitating the extension. (c) The model year report must include the following information: (1)(i) All fuel economy data used in the FTP/HFET-based model type calculations under § 600.208, and subsequently required by the Administrator in accordance with § 600.507; (ii) All carbon-related exhaust emission data used in the FTP/HFET-based model type calculations under § 600.208, and subsequently required by the Administrator in accordance with § 600.507; (2) (i) All fuel economy data for certification vehicles and for vehicles tested for running changes approved under § 86.1842 of this chapter; (ii) All carbon-related exhaust emission data for certification vehicles and for vehicles tested for running changes approved under § 86.1842 of this chapter; (3) Any additional fuel economy and carbon-related exhaust emission data submitted by the manufacturer under § 600.509; (4)(i) A fuel economy value for each model type of the manufacturer's product line calculated according to § 600.510-12(b)(2); (ii) A carbon-related exhaust emission value for each model type of the manufacturer's product line calculated according to § 600.510-12(b)(2); (5)(i) The manufacturer's average fuel economy value calculated according to § 600.510-12(c); (ii) The manufacturer's average carbon-related exhaust emission value calculated according to § 600.510-12(j); (6) A listing of both domestically and nondomestically produced car lines as determined in § 600.511 and the cost information upon which the determination was made; and (7) The authenticity and accuracy of production data must be attested to by the corporation, and shall bear the signature of an officer (a corporate executive of at least the rank of vice-president) designated by the corporation. Such attestation shall constitute a representation by the manufacturer that the manufacturer has established reasonable, prudent procedures to ascertain and provide production data that are accurate and authentic in all material respects and that these procedures have been followed by employees of the manufacturer involved in the reporting process. The signature of the designated officer shall constitute a representation by the required attestation. (8) [Reserved] (9) The “required fuel economy level” pursuant to 49 CFR parts 531 or 533, as applicable. Model year reports shall include information in sufficient detail to verify the accuracy of the calculated required fuel economy level, including but is not limited to, production information for each unique footprint within each model type contained in the model year report and the formula used to calculate the required fuel economy level. Model year reports shall include a statement that the method of measuring vehicle track width, measuring vehicle wheelbase and calculating vehicle footprint is accurate and complies with applicable Department of Transportation requirements. (10) The “required fuel economy level” pursuant to 49 CFR parts 531 or 533 as applicable, and the applicable fleet average CO 2 emission standards. Model year reports shall include information in sufficient detail to verify the accuracy of the calculated required fuel economy level and fleet average CO 2 emission standards, including but is not limited to, production information for each unique footprint within each model type contained in the model year report and the formula used to calculate the required fuel economy level and fleet average CO 2 emission standards. Model year reports shall include a statement that the method of measuring vehicle track width, measuring vehicle wheelbase and calculating vehicle footprint is accurate and complies with applicable Department of Transportation and EPA requirements. (11) A detailed (but easy to understand) list of vehicle models and the applicable in-use CREE emission standard. The list of models shall include the applicable carline/subconfiguration parameters (including carline, equivalent test weight, road-load horsepower, axle ratio, engine code, transmission class, transmission configuration and basic engine); the test parameters (ETW and a, b, c, dynamometer coefficients) and the associated CREE emission standard. The manufacturer shall provide the method of identifying EPA engine code for applicable in-use vehicles." 40:40:32.0.1.4.44.6.13.7,40,Protection of Environment,I,Q,600,PART 600—FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES,F,Subpart F—Procedures for Determining Manufacturer's Average Fuel Economy and Manufacturer's Average Carbon-Related Exhaust Emissions,,§ 600.513-08 Gas Guzzler Tax.,EPA,,,"[76 FR 39569, July 6, 2011]","(a) This section applies only to passenger automobiles sold after December 27, 1991, regardless of the model year of those vehicles. For alcohol dual fuel and natural gas dual fuel automobiles, the fuel economy while such automobiles are operated on gasoline will be used for Gas Guzzler Tax assessments. (1) The provisions of this section do not apply to passenger automobiles exempted for Gas Guzzler Tax assessments by applicable Federal law and regulations. However, the manufacturer of an exempted passenger automobile may, in its discretion, label such vehicles in accordance with the provisions of this section. (2) For 1991 and later model year passenger automobiles, the combined FTP/HFET-based model type fuel economy value determined in § 600.208 used for Gas Guzzler Tax assessments shall be calculated in accordance with the following equation, rounded to the nearest 0.1 mpg: FE adj = FE[((0.55 × a g × c) + (0.45 × c) + (0.5556 × a g ) + 0.4487)/((0.55 × a g ) + 0.45)] + IW g Where: FE adj = Fuel economy value to be used for determination of gas guzzler tax assessment rounded to the nearest 0.1 mpg. FE = Combined model type fuel economy calculated in accordance with § 600.208, rounded to the nearest 0.0001 mpg. a g = Model type highway fuel economy, calculated in accordance with § 600.208, rounded to the nearest 0.0001 mpg divided by the model type city fuel economy calculated in accordance with § 600.208, rounded to the nearest 0.0001 mpg. The quotient shall be rounded to 4 decimal places. c = gas guzzler adjustment factor = 1.300 × 10 −3 for the 1986 and later model years. IW g = (9.2917 × 10 −3 × SF 3IWCG FE 3IWCG ) − (3.5123 × 10 −3 × SF 4ETWG × FE 4IWCG ). Note: Any calculated value of IW less than zero shall be set equal to zero. SF 3IWCG = The 3000 lb. inertia weight class sales in the model type divided by the total model type sales; the quotient shall be rounded to 4 decimal places. SF 4ETWG = The 4000 lb. equivalent test weight sales in the model type divided by the total model type sales, the quotient shall be rounded to 4 decimal places. FE 3IWCG = The 3000 lb. inertial weight class base level combined fuel economy used to calculate the model type fuel economy rounded to the nearest 0.0001 mpg. FE 4IWCG = The 4000 lb. inertial weight class base level combined fuel economy used to calculate the model type fuel economy rounded to the nearest 0.001 mpg. Where: FE adj = Fuel economy value to be used for determination of gas guzzler tax assessment rounded to the nearest 0.1 mpg. FE = Combined model type fuel economy calculated in accordance with § 600.208, rounded to the nearest 0.0001 mpg. a g = Model type highway fuel economy, calculated in accordance with § 600.208, rounded to the nearest 0.0001 mpg divided by the model type city fuel economy calculated in accordance with § 600.208, rounded to the nearest 0.0001 mpg. The quotient shall be rounded to 4 decimal places. c = gas guzzler adjustment factor = 1.300 × 10 −3 for the 1986 and later model years. IW g = (9.2917 × 10 −3 × SF 3IWCG FE 3IWCG ) − (3.5123 × 10 −3 × SF 4ETWG × FE 4IWCG ). Any calculated value of IW less than zero shall be set equal to zero. SF 3IWCG = The 3000 lb. inertia weight class sales in the model type divided by the total model type sales; the quotient shall be rounded to 4 decimal places. SF 4ETWG = The 4000 lb. equivalent test weight sales in the model type divided by the total model type sales, the quotient shall be rounded to 4 decimal places. FE 3IWCG = The 3000 lb. inertial weight class base level combined fuel economy used to calculate the model type fuel economy rounded to the nearest 0.0001 mpg. FE 4IWCG = The 4000 lb. inertial weight class base level combined fuel economy used to calculate the model type fuel economy rounded to the nearest 0.001 mpg. (b)(1) For passenger automobiles sold after December 31, 1990, with a combined FTP/HFET-based model type fuel economy value of less than 22.5 mpg (as determined in § 600.208), calculated in accordance with paragraph (a)(2) of this section and rounded to the nearest 0.1 mpg, each vehicle fuel economy label shall include a Gas Guzzler Tax statement pursuant to 49 U.S.C. 32908(b)(1)(E). The tax amount stated shall be as specified in paragraph (b)(2) of this section. (2) For passenger automobiles with a combined general label model type fuel economy value of:"