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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 A…
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 an…
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 use…
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 les…
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, temp…
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 crite…
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 s…
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…
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 …
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 writ…
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…
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 reasona…
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 cours…
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 …
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 ed…
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 n…
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…
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 …
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…
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…
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 corporati…
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 educa…
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 a…
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 e…
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 …
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 pro…
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— …
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 me…
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 veterina…
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 a…
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, ex…
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, Approve…
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)…
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…
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 …
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 …
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 a…
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 t…
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 e…
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 thos…
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 vehicl…
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 SC…
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,…
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 powe…
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…
40:40:32.0.1.4.44.3.13.1 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 …
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…
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 m…
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/ve…
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 …
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…
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 …
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…
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…
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 …
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…
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 t…
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 expres…
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 …
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 …
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 examin…
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 ye…
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 ac…
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 import…
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…
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 b…

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