section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 14:14:2.0.1.3.15.1.9.1,14,Aeronautics and Space,I,F,97,PART 97—STANDARD INSTRUMENT PROCEDURES,A,Subpart A—General,,§ 97.1 Applicability.,FAA,,,"[Docket FAA-2002-14002, 72 FR 31679, June 7, 2007, as amended by FAA-2023-1275, Amdt. 97-1340, 89 FR 92486, Nov. 21, 2024]","(a) This part prescribes standard instrument approach procedures to civil airports in the United States and the weather minimums that apply to landings under IFR at those airports. (b) This part also prescribes obstacle departure procedures (ODPs) for certain civil airports in the United States and the weather minimums that apply to takeoffs under IFR at civil airports in the United States. (c) Additional applicability of copter procedures for powered-lift is set forth in part 194 of this chapter." 14:14:2.0.1.3.15.1.9.2,14,Aeronautics and Space,I,F,97,PART 97—STANDARD INSTRUMENT PROCEDURES,A,Subpart A—General,,§ 97.3 Symbols and terms used in procedures.,FAA,,,"[Docket FAA-2002-14002, 72 FR 31679, June 7, 2007]","As used in the standard instrument procedures prescribed in this part— Aircraft approach category means a grouping of aircraft based on a speed of VREF, if specified, or if VREF is not specified, 1.3 V so at the maximum certificated landing weight. VREF, V so , and the maximum certificated landing weight are those values as established for the aircraft by the certification authority of the country of registry. The categories are as follows— (1) Category A: Speed less than 91 knots. (2) Category B: Speed 91 knots or more but less than 121 knots. (3) Category C: Speed 121 knots or more but less than 141 knots. (4) Category D: Speed 141 knots or more but less than 166 knots. (5) Category E: Speed 166 knots or more. Approach procedure segments for which altitudes (minimum altitudes, unless otherwise specified) and paths are prescribed in procedures, are as follows— (1) Initial approach is the segment between the initial approach fix and the intermediate fix or the point where the aircraft is established on the intermediate course or final approach course. (2) Initial approach altitude is the altitude (or altitudes, in high altitude procedure) prescribed for the initial approach segment of an instrument approach. (3) Intermediate approach is the segment between the intermediate fix or point and the final approach fix. (4) Final approach is the segment between the final approach fix or point and the runway, airport, or missed approach point. (5) Missed approach is the segment between the missed approach point, or point of arrival at decision altitude or decision height (DA/DH), and the missed approach fix at the prescribed altitude. Ceiling means the minimum ceiling, expressed in feet above the airport elevation, required for takeoff or required for designating an airport as an alternate airport. Copter procedures means helicopter procedures, with applicable minimums as prescribed in § 97.35. Helicopters may also use other procedures prescribed in subpart C of this part and may use the Category A minimum descent altitude (MDA), or decision altitude or decision height (DA/DH). For other than “copter-only” approaches, the required visibility minimum for Category I approaches may be reduced to one-half the published visibility minimum for Category A aircraft, but in no case may it be reduced to less than one-quarter mile prevailing visibility, or, if reported, 1,200 feet RVR. Reduction of visibility minima on Category II instrument approach procedures is prohibited. FAF means final approach fix. HAA means height above airport and is expressed in feet. HAL means height above landing and is the height of the DA/MDA above a designated helicopter landing area elevation used for helicopter instrument approach procedures and is expressed in feet. HAS means height above the surface and is the height of the DA/MDA above the highest terrain/surface within a 5,200-foot radius of the missed approach point used in helicopter instrument approach procedures and is expressed in feet above ground level (AGL). HAT means height above touchdown. HCH means helipoint crossing height and is the computed height of the vertical guidance path above the helipoint elevation at the helipoint expressed in feet. Helipoint means the aiming point for the final approach course. It is normally the center point of the touchdown and lift-off area (TLOF). Hold in lieu of PT means a holding pattern established under applicable FAA criteria, and used in lieu of a procedure turn to execute a course reversal. MAP means missed approach point. More than 65 knots means an aircraft that has a stalling speed of more than 65 knots (as established in an approved flight manual) at maximum certificated landing weight with full flaps, landing gear extended, and power off. MSA means minimum safe altitude, expressed in feet above mean sea level, depicted on an approach chart that provides at least 1,000 feet of obstacle clearance for emergency use within a certain distance from the specified navigation facility or fix. NA means not authorized. NOPT means no procedure turn required. Altitude prescribed applies only if procedure turn is not executed. Procedure turn means the maneuver prescribed when it is necessary to reverse direction to establish the aircraft on an intermediate or final approach course. The outbound course, direction of turn, distance within which the turn must be completed, and minimum altitude are specified in the procedure. However, the point at which the turn may be begun, and the type and rate of turn, is left to the discretion of the pilot. RA means radio altimeter setting height. RVV means runway visibility value. SIAP means standard instrument approach procedure. 65 knots or less means an aircraft that has a stalling speed of 65 knots or less (as established in an approved flight manual) at maximum certificated landing weight with full flaps, landing gear extended, and power off. T means nonstandard takeoff minimums or specified departure routes/procedures or both. TDZ means touchdown zone. Visibility minimum means the minimum visibility specified for approach, landing, or takeoff, expressed in statute miles, or in feet where RVR is reported." 14:14:2.0.1.3.15.1.9.3,14,Aeronautics and Space,I,F,97,PART 97—STANDARD INSTRUMENT PROCEDURES,A,Subpart A—General,,"§ 97.5 Bearings, courses, tracks, headings, radials, miles.",FAA,,,"[Docket 561, 32 FR 13912, Oct. 6, 1967, as amended by Amdt. 97-1336, 72 FR 31680, June 7, 2007]","(a) All bearings, courses, tracks, headings, and radials in this part are magnetic, unless otherwise designated. (b) RVR values are stated in feet. Other visibility values are stated in statute miles. All other mileages are stated in nautical miles." 14:14:2.0.1.3.15.2.9.1,14,Aeronautics and Space,I,F,97,PART 97—STANDARD INSTRUMENT PROCEDURES,B,Subpart B—Procedures,,§ 97.10 [Reserved],FAA,,,, 14:14:2.0.1.3.15.3.9.1,14,Aeronautics and Space,I,F,97,PART 97—STANDARD INSTRUMENT PROCEDURES,C,Subpart C—TERPS Procedures,,§ 97.20 General.,FAA,,,"[Docket FAA-2002-14002, 72 FR 31680, June 7, 2007, as amended by Docket FAA-2018-0119, Amdt. 97-1338, 83 FR 9172, Mar. 5, 2018; Docket FAA-2022-1355, Amdt. 97-1339, 87 FR 75846, Dec. 9, 2022]","(a) This subpart prescribes standard instrument approach procedures and takeoff minimums and obstacle departure procedures (ODPs) based on the criteria contained in FAA Order 8260.3, U.S. Standard for Terminal Instrument Procedures (TERPs), and other related Orders in the 8260 series that also address instrument procedure design criteria. (b) Standard instrument approach procedures and associated supporting data adopted by the FAA are documented on FAA Forms 8260-3, 8260-4, 8260-5. Takeoff minimums and obstacle departure procedures (ODPs) are documented on FAA Form 8260-15A. These forms are incorporated by reference. The Director of the Federal Register approved this incorporation by reference pursuant to 5 U.S.C. 552(a) and 1 CFR part 51. The standard instrument approach procedures and takeoff minimums and obstacle departure procedures (ODPs) are available for examination at the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590, and at Aeronautical Information Services, 1305 East-West Highway, Silver Spring, MD 20910, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: fedreg.legal@nara.gov , or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) Standard instrument approach procedures and takeoff minimums and obstacle departure procedures (ODPs) are depicted on aeronautical charts published by the FAA. These charts are available from the FAA at https://www.faa.gov/air_traffic/flight_info/aeronav/digital_products/." 28:28:2.0.1.1.41.0.31.1,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.1 Purpose.,DOJ,,,,"This part implements the provisions of The Interstate Transportation of Dangerous Criminals Act of 2000, Public Law 106-560, 114 Stat. 2784 (42 U.S.C. 13726b) (enacted December 21, 2000) (“the Act”), to provide minimum security and safety standards for private companies that transport violent prisoners on behalf of State and local jurisdictions." 28:28:2.0.1.1.41.0.31.10,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.18 Notification of local law enforcement prior to scheduled stops.,DOJ,,,,"When transporting violent prisoners, private prisoner transport companies are required to notify local law enforcement officials 24 hours in advance of any scheduled stops in their jurisdiction. For the purposes of this part, a scheduled stop is defined as a predetermined stop at a State, local, or private correctional facility for the purpose of loading or unloading prisoners or using such facilities for overnight, meal, or restroom breaks. Scheduled stops do not include routine fuel stops or emergency stops." 28:28:2.0.1.1.41.0.31.11,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.19 Immediate notification of local law enforcement in the event of an escape.,DOJ,,,,"Private prisoner transport companies must be sufficiently equipped to provide immediate notification to law enforcement in the event of a prisoner escape. Law enforcement officials must receive notification no later than 15 minutes after an escape is detected unless the company can demonstrate that extenuating circumstances necessitated a longer delay. In the event of the escape of a violent prisoner, a private prisoner transport company must: (a) Ensure the safety and security of the remaining prisoners; (b) Provide notification within 15 minutes to the appropriate State and local law enforcement officials; (c) Provide notification as soon as practicable to the governmental entity or the privately run incarceration facility that contracted with the transport company; and (d) Provide complete descriptions of the escapee and the circumstances surrounding the escape to State and local law enforcement officials if needed." 28:28:2.0.1.1.41.0.31.12,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.20 Standards to ensure the safety of violent prisoners during transport.,DOJ,,,,"Companies covered under this section must comply with applicable State and federal laws that govern the safety of violent prisoners during transport. In addition, companies covered under this section are to ensure that: (a) Protective measures are in place to ensure that all vehicles are safe and well-maintained; (b) Vehicles are equipped with efficient communications systems that are capable of immediately notifying State and local law enforcement officials in the event of a prisoner escape; (c) Policies, practices, and procedures are in effect to ensure the health and physical safety of the prisoners during transport, including a first-aid kit and employees who are qualified to dispense medications and administer CPR and emergency first-aid; (d) Policies, practices, and procedures are in effect to prohibit the mistreatment of prisoners, including prohibitions against covering a prisoner's mouth with tape, the use of excessive force, and sexual misconduct; (e) Policies, practices, and procedures are in effect to ensure that juvenile prisoners are separated from adult prisoners during transportation, where practicable; (f) Policies, practices, and procedures are in effect to ensure that female prisoners are separated from male prisoners during transportation, where practicable; (g) Policies, practices, and procedures are in effect to ensure that female guards are on duty to supervise the transportation of female violent prisoners, where practicable; (h) Staff are well trained in the handling and restraint of prisoners, including the proper use of firearms and other restraint devices, and have received specialized training in the area of sexual harassment; and (i) Private transport companies are responsible for taking reasonable measures to insure the well being of the prisoners in their custody including, but not limited to, necessary stops for restroom use and meals, proper heating and ventilation of the transport vehicle, climate-appropriate uniforms, and prohibitions on the use of tobacco, in any form, in the transport vehicle." 28:28:2.0.1.1.41.0.31.13,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,"§ 97.22 No pre-emption of federal, State, or local laws or regulations.",DOJ,,,,"The regulations in this part implement the Act and do not pre-empt any applicable federal, State, or local law that may impose additional obligations on private prisoner transport companies or otherwise regulate the transportation of violent prisoners. All federal laws and regulations governing interstate commerce will continue to apply to private prisoner transport companies including, but not limited to: federal laws regulating the possession of weapons, Federal Aviation Administration or Transportation Security Administration rules and regulations governing travel on commercial aircraft, and all applicable federal, State, or local motor carrier regulations. The regulations in this part in no way pre-empt, displace, or affect the authority of States, local governments, or other federal agencies to address these issues." 28:28:2.0.1.1.41.0.31.14,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.24 No civil defense created.,DOJ,,,,"The regulations in this part on private prisoner transport companies are not intended to create a defense to any civil action, whether initiated by a unit of government or any other party. Compliance with the regulations in this part is not intended to and does not establish a defense against an allegation of negligence or breach of contract. Regardless of whether a contractual agreement establishes minimum precautions, the companies affected by the regulations in this part will remain subject to the standards of care that are imposed by constitutional, statutory, and common law upon their activities (or other activities of a similarly hazardous nature)." 28:28:2.0.1.1.41.0.31.15,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.30 Enforcement.,DOJ,,,,"Any person who is found in violation of the regulations in this part will: (a) Be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each violation; (b) Be liable to the United States for the costs of prosecution; and (c) Make restitution to any entity of the United States, of a State, or of an inferior political subdivision of a State, that expends funds for the purpose of apprehending any violent prisoner who escapes from a prisoner transport company as the result, in whole or in part, of a violation of the regulations in this part promulgated pursuant to the Act." 28:28:2.0.1.1.41.0.31.2,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.2 Definitions.,DOJ,,,,"(a) Crime of violence. The term “crime of violence” has the same meaning as in section 924(c)(3) of title 18, United States Code. Section 924(c)(3) states that the term crime of violence means an offense that is a felony and has as an element the use, attempted use, or threatened use of physical force against the person or property of another, or that by its nature, involves a substantial risk that physical force against the person or property of another may be used in the course of committing the offense. (b) Private prisoner transport company. The term “private prisoner transport company” (“company”) means any entity, other than the United States, a State, or an inferior political subdivision of a State, that engages in the business of transporting for compensation individuals committed to the custody of any State or of an inferior political subdivision of a State, or any attempt thereof. (c) Violent prisoner. The term “violent prisoner” means any individual in the custody of a State or an inferior political subdivision of a State who has previously been convicted of or is currently charged with a crime of violence or any similar statute of a State or the inferior political subdivisions of a State, or any attempt thereof." 28:28:2.0.1.1.41.0.31.3,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.11 Pre-employment screening.,DOJ,,,,"Private prisoner transport companies must adopt pre-employment screening measures for all potential employees. The pre-employment screening measures must include a background check and a test for use of controlled substances. The failure of a potential employee to pass either screening measure will act as a bar to employment. (a) Background checks must include: (1) A fingerprint-based criminal background check that disqualifies persons with either a prior felony conviction or a State or Federal conviction for a misdemeanor crime of domestic violence as defined in 18 U.S.C. 921; (2) A Credit Report check; (3) A physical examination; and (4) A personal interview. (b) Testing for controlled substances. (1) Pre-employment testing for controlled substances must be in accordance with applicable State law. (2) In the event that there is no applicable State law, pre-employment testing for controlled substances must be in accordance with the provisions of Department of Transportation regulations at 49 CFR 382.301 which will apply regardless of whether a private prisoner transport company is covered by Department of Transportation regulations. (c) The criminal background check references in paragraph (a)(1) of this section may not be submitted directly to the FBI or any other Federal agency. The private prisoner transport companies must arrange the procedures for accomplishing the criminal background checks with their contracting governmental agencies. In the event that the private prisoner transport company is contracting with a privately run incarceration facility, and not directly with a governmental entity, the private prisoner transport company will have to make arrangements through the private incarceration facility to have the checks completed by the governmental entity ultimately requesting the transport." 28:28:2.0.1.1.41.0.31.4,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.12 Employee training.,DOJ,,,,"Private prisoner transport companies must require the completion of a minimum of 100 hours of employee training before an employee may transport violent prisoners. Training must include instruction in each of these six areas: (a) Use of restraints; (b) Searches of prisoners; (c) Use of force, including use of appropriate weapons and firearms; (d) Cardiopulmonary resuscitation (CPR); (e) Map reading; and (f) Defensive driving." 28:28:2.0.1.1.41.0.31.5,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.13 Maximum driving time.,DOJ,,,,"Companies covered under this part must adhere to the maximum driving time provisions applicable to commercial motor vehicle operators, as set forth in Department of Transportation regulations at 49 CFR 395.3 which will apply regardless of whether a private prisoner transport company is covered by Department of Transportation regulations." 28:28:2.0.1.1.41.0.31.6,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.14 Guard-to-prisoner ratio.,DOJ,,,,Companies covered under this part must adhere to certain minimum standards with respect to the number of employees required to monitor violent prisoners during transportation. Private prisoner transport companies must ensure that at least one guard be on duty for every six violent prisoners transported. This requirement does not preclude a contracting entity from establishing more stringent guard-to-prisoner ratios. 28:28:2.0.1.1.41.0.31.7,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.15 Employee uniforms and identification.,DOJ,,,,"(a) Employee uniforms. Uniforms used by private prisoner transport companies must meet the following requirements: (1) Uniforms must be readily distinguishable in style and color from official uniforms worn by United States Department of Justice employees who transport violent offenders; (2) Uniforms must prominently feature a badge or insignia that identifies the employee as a prisoner transportation employee; and (3) Uniforms must be worn at all times while the employee is engaged in the transportation of violent prisoners. (b) Employee identification. Identification utilized by private prisoner transport companies must meet the following requirements: (1) The identification credentials must clearly identify the employee as a transportation employee. The credentials must have a photograph of the employee that is at least one inch square, a printed personal description of the employee including the employee's name, the signature of the employee, and date of issuance; and (2) The employee must display proper identification credentials on his or her uniform and ensure that the identification is visible at all times during the transportation of violent prisoners." 28:28:2.0.1.1.41.0.31.8,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.16 Clothing requirements for transported violent prisoners.,DOJ,,,,"Companies covered under this part must ensure that all violent prisoners they transport are clothed in brightly colored clothing that clearly identifies them as violent prisoners, unless security or other specific considerations make such a requirement inappropriate." 28:28:2.0.1.1.41.0.31.9,28,Judicial Administration,I,,97,PART 97—STANDARDS FOR PRIVATE ENTITIES PROVIDING PRISONER OR DETAINEE SERVICES,,,,§ 97.17 Mandatory restraints to be used while transporting violent prisoners.,DOJ,,,,"Companies covered under this part must, at a minimum, require that violent prisoners be transported wearing handcuffs, leg irons, and waist chains unless the use of all three restraints would create a serious health risk to the prisoner, or extenuating circumstances (such as pregnancy or physical disability) make the use of all three restraints impracticable." 33:33:1.0.1.6.48.1.26.1,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.100 Applicability—Electronic documentation.,USCG,,,,"(a) This subpart applies to— (1) A self-propelled cargo vessel of 500 gross tons or more, on an international voyage, that must comply with Chapter VI/5.6 or Chapter VII/5 of the International Convention for the Safety of Life at Sea, 1974 as amended (SOLAS), that does not solely carry liquid or solid cargoes in bulk, and that is either a U.S.-flagged self-propelled cargo vessel, or a foreign-flagged self-propelled cargo vessel that is operating in waters subject to the jurisdiction of the United States; (2) A U.S.-flagged self-propelled cargo vessel that chooses to have this subpart applied to it by submitting a cargo securing manual for approval in accordance with § 97.200(a)(3); (3) A foreign-flagged self-propelled cargo vessel of 500 gross tons or more on an international voyage from a country that is not a signatory to SOLAS, that would otherwise be required to comply with Chapter VI/5.6 or Chapter VII/5 of SOLAS, that does not solely carry liquid or solid cargoes in bulk, and that is operating in waters subject to the jurisdiction of the United States; and (4) Any organization applying to be selected as a cargo securing manual approval authority. (b) This subpart does not apply to a vessel owned by the Maritime Administration that is part of the Ready Reserve Force or the title of which is vested in the United States and which is used for public purposes only. (c) Any manual, letter, request, appeal, or ruling required by this subpart may be provided or submitted in electronic form or in printed form." 33:33:1.0.1.6.48.1.26.10,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§§ 97.211-97.299 [Reserved],USCG,,,, 33:33:1.0.1.6.48.1.26.11,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.300 Authorized cargo securing manual (CSM) approval authorities.,USCG,,,,"The following organizations are authorized to act on behalf of the United States for the review and approval of CSMs: (a) Any recognized classification society to which the Coast Guard has delegated issuance of a Cargo Ship Safety Equipment Certificate in accordance with 46 CFR 8.320(b)(4). A list of these organizations can be found at www.uscg.mil/hq/cg5/cg522/cg5222 in the “Summary of Authorizations” link. (b) The National Cargo Bureau, Inc., 17 Battery Place, Suite 1232, New York, NY 10004-1110, 212-785-8300, http://www.natcargo.org." 33:33:1.0.1.6.48.1.26.12,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.305 Requests for authorization to act as cargo securing manual (CSM) approval authority.,USCG,,,,"An organization seeking authorization as a CSM approval authority must make a request to the Commandant for authorization. The request must include, in writing, the items listed in this section or as otherwise specified by the Commandant. (a) A certified copy of the organization's certificate of incorporation or partnership on file with a U.S. State, including the name and address of the organization, with written statements or documents which show that— (1) The organization's owners, managers, and employees are free from influence or control by vessel shipbuilders, owners, operators, lessors, or other related commercial interests as evidenced by past and present business practices; (2) The organization has demonstrated, through other related work, the capability to competently evaluate CSMs for completeness and sufficiency according to the requirements of SOLAS and this part; (3) The organization has an acceptable degree of financial security, based on recent audits by certified public accountants over the last 5 years; and (4) The organization maintains a corporate office in the United States that has adequate resources and staff to support all aspects of CSM review, approval, and recordkeeping. (b) A listing of the names of the organization's principal executives, with titles, telephone, and telefax numbers. (c) A written general description of the organization, covering the ownership, managerial structure, and organization components, including any directly affiliated organizations, and their functions utilized for supporting technical services. (d) A written list of technical services the organization offers. (e) A written general description of the geographical area the organization serves. (f) A written general description of the clients the organization is serving, or intends to serve. (g) A written general description of similar work performed by the organization in the past, noting the amount and extent of such work performed within the previous 3 years. (h) A written listing of the names of full-time professional staff employed by the organization and available for technical review and approval of CSMs including— (1) Naval architects and naval engineers, with copies of their professional credentials, college degrees, and specialized training certificates; (2) Merchant mariners with Coast Guard-issued credentials, with a summary of their working experience on board cargo vessels (including vessel tonnage and types of cargo); and (3) Written proof of staff competence to perform CSM review and approval, evidenced by detailed summaries of each individual's experience (measured in months) during the past 5 years of evaluating maritime cargo securing systems. Experience summaries must be documented on company letterhead and endorsed by a company executive who has had direct observation of the individual and quality of his or her work product. (j) A complete description of the organization's internal quality control processes, including written standards used by the organization to ensure consistency in CSM review and approval procedures by qualified professionals. (k) A description of the organization's training program for assuring continued competency of professional employees performing CSM review and approval who are identified in the application. (l) Evidence of financial stability over the past 5-year period, such as financial reports completed independently by certified public accountants. (m) A list of five or more business references, including names, addresses, and telephone numbers of principal executives, who can attest to the organization's competence within the past 2 years. (n) A statement to the Coast Guard that gives its officials permission to inspect the organization's facilities and records of CSM review and approval on behalf of the United States at any time with reasonable advance notice. (o) Any additional information the organization deems to be pertinent." 33:33:1.0.1.6.48.1.26.13,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.310 Criteria for authorization.,USCG,,,,"(a) The Commandant will evaluate the organization's request for authorization and supporting written materials, looking for evidence of— (1) The organization's clear assignment of management duties; (2) Ethical standards for managers and cargo securing manual (CSM) reviewers; (3) Procedures for personnel training, qualification, certification, and re-qualification that are consistent with recognized industry standards; (4) Acceptable standards available for the organization's internal auditing and management review; (5) Recordkeeping standards for CSM review and approval; (6) Methods used to review and certify CSMs; (7) Experience and knowledge demonstrating competency to evaluate CSMs for completeness and sufficiency according to the requirements of SOLAS; (8) Methods for handling appeals; and (9) Overall procedures consistent with Res.A.739(18), (incorporated by reference, see § 97.110). (b) After a favorable evaluation of the organization's request, the Commandant may arrange to visit the organization's corporate and port offices for an on-site evaluation of operations. (c) When a request is approved, the organization and the Coast Guard will enter into the written agreement provided for by 33 CFR 97.315. If the request is not approved, the Commandant will give the organization a written explanation, and the organization may resubmit its request if it corrects any noted deficiencies." 33:33:1.0.1.6.48.1.26.14,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.315 Requirements for authorized approval organizations.,USCG,,,,"Approved organizations will enter into a written agreement with the Coast Guard that specifies— (a) The period the authorization is valid; (b) Which duties and responsibilities the organization may perform and what approval letters it may issue on behalf of the U.S.; (c) Reports and information the organization must send to the Commandant; (d) Actions the organization must take to renew the agreement when it expires; and (e) Actions the organization must take if the Commandant revokes authorization pursuant to 33 CFR 97.320." 33:33:1.0.1.6.48.1.26.15,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.320 Revocation of authorization.,USCG,,,,"The Commandant may revoke a cargo securing manual (CSM) approval authority's authorization and remove it from the list of CSM approval authorities if it fails to maintain acceptable standards. For the purposes of 46 CFR subpart 1.03, such a revocation would be treated as involving the recognition of a classification society and could be appealed pursuant to 46 CFR 1.03-15(h)(4). Upon revocation, the former approval authority must send written notice to each vessel owner whose CSM it approved. The notice must include the current list of CSM approval authorities and state— (a) That its authorization as a CSM approval authority has been revoked; (b) The Coast Guard's explanation for the revocation; and (c) That the vessel's CSM remains valid as long as amendments have not been completed which require it to be re-approved pursuant to 33 CFR 97.200 or 97.205." 33:33:1.0.1.6.48.1.26.2,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.105 Definitions.,USCG,,,,"As used in this subpart— Approval authority means a CSM approval authority, as that term is defined in this section. Cargo means the goods or merchandise conveyed in a vessel, and includes, but is not limited to, cargo that can be measured as a “cargo unit” as that term is used in the International Maritime Organization's Code of Safe Practice for Cargo Stowage and Securing, 2003 edition: “a vehicle, container, flat, pallet, portable tank, packaged unit, or any other entity, etc., and loading equipment, or any part thereof, which belongs to the ship but is not fixed to the ship . . .”; but it does not include other vessel equipment or the incidental personal possessions of persons on board the vessel. Cargo safe access plan (CSAP) means a plan included in the cargo securing manual that provides detailed information on safe access for persons engaged in work connected with cargo stowage and securing on ships that are specifically designed and fitted for the purpose of carrying containers. Cargo securing manual (CSM) means an electronic or printed manual developed to meet the requirements of SOLAS and this subpart and that is used by the master of a vessel to properly stow and secure cargoes on the vessel for which it is developed. Cargo securing manual approval authority or CSM approval authority means an organization that meets the requirements of this subpart, and that the Commandant has authorized to conduct certain actions and issue electronic or printed approval letters on behalf of the United States. Captain of the Port (COTP) means the U.S. Coast Guard officer as described in 33 CFR 6.01-3. Commandant, except as otherwise specified, means the Chief, Office of Operating and Environmental Standards, whose address is Commandant (CG-OES), 2703 Martin Luther King, Jr. Avenue SE., Stop 7509, Washington, DC 20593-7509 and whose telephone number is 202-372-1404. Container means an article of transport equipment described in 49 CFR 450.3. Container vessel means a vessel specifically designed and fitted for the purpose of carrying containers. International voyage means a voyage between a port or place in one country (or its possessions) and a port or place in another country." 33:33:1.0.1.6.48.1.26.3,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.110 Incorporation by reference.,USCG,,,"[USCG-2000-7080, 81 FR 28014, May 9, 2016, as amended by USCG-2024-1103, 90 FR 52876, Nov. 24, 2025]","(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection by contacting Mr. Douglas Lincoln, of the Coast Guard's Vessel and Facility Operating Standards Division, Commandant (CG-OES-2); telephone 571-613-1069, email Douglas.R.Lincoln3@uscg.mil, and is available from the sources listed below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: fr.inspection@nara.gov, or go to: www.archives.gov/federal-register/cfr/ibr-locations. (b) International Maritime Organization (IMO), Publications Section, 4 Albert Embankment, London, SE1 7SR, United Kingdom, +44(0)20 7735 7611, http://www.imo.org. (1) MSC.1/Circ.1352, Amendments to the Code of Safe Practice for Cargo Stowage and Securing (CSS Code), June 30, 2010 (Maritime Safety Committee Circular), IBR approved for § 97.120(b). (2) MSC.1/Circ. 1353/Rev.1, Revised Guidelines for the Preparation of the Cargo Securing Manual, December 15, 2014 (Maritime Safety Committee Circular), IBR approved for § 97.120(a). (3) Resolution A.739(18) (Res.A.739(18)), Guidelines for the Authorization of Organizations Acting on Behalf of the Administration, November 22, 1993 (Assembly Resolution), IBR approved for § 97.310(a)." 33:33:1.0.1.6.48.1.26.4,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.115 Reporting lost or jettisoned cargo.,USCG,,,"[USCG-2000-7080, 81 FR 28014, May 9, 2016; 81 FR 59136, Aug. 29, 2016]","(a) In the event a vessel loses or jettisons at sea any cargo described in paragraph (b) of this section, it must comply with the immediate notification requirements of 33 CFR 160.216, and if the cargo contains hazardous material as defined in paragraph (c) of this section, the vessel must also report it as soon as possible in accordance with 49 CFR 176.48. (b) The cargo to which this section applies includes any container and any other cargo the loss or jettisoning of which could adversely affect the safety of any vessel, bridge, structure, or shore area or the environmental quality of any port, harbor, or navigable waterway of the United States. (c) As used in this section, “hazardous material” means a substance or material designated by the Secretary of Transportation as capable of posing an unreasonable risk to health, safety, and property when transported in commerce. The term includes hazardous substances, hazardous wastes, marine pollutants, and elevated temperature materials as defined in 49 CFR 171.8, materials designated as hazardous under the provisions of 49 CFR 172.101, and materials that meet the defining criteria for hazard classes and divisions in 49 CFR part 173." 33:33:1.0.1.6.48.1.26.5,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.120 Cargo securing manuals.,USCG,,,,"(a) Any vessel to which this subpart applies must have a cargo securing manual (CSM) on board that has been approved by the government of the country whose flag the vessel is entitled to fly; and a CSM approved after June 30, 2010, must, at a minimum, meet the guidelines in MSC.1/Circ. 1353/Rev.1, (incorporated by reference, see 33 CFR 97.110). (b) A container vessel with a keel laid on or after January 1, 2015, must include a cargo safe access plan that, at a minimum, meets the guidelines in MSC.1/Circ.1352, Annex 14, Guidance on Providing Safe Working Conditions for Securing of Containers on Deck (incorporated by reference, see 33 CFR 97.110). (c) While operating in waters under the jurisdiction of the United States, the Coast Guard may board any vessel to which this subpart applies to determine that the vessel has the document(s) required by paragraph (a) of this section on board. Any foreign-flagged vessel found not to be in compliance with paragraph (a) of this section may be detained by order of the Captain of the Port at the port or terminal where the noncompliance is found until the COTP determines that the vessel can go to sea without presenting an unreasonable threat of harm to the port, the marine environment, the vessel, or its crew." 33:33:1.0.1.6.48.1.26.6,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§§ 97.121-97.199 [Reserved],USCG,,,, 33:33:1.0.1.6.48.1.26.7,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.200 Cargo securing manual (CSM) approval for U.S.-flagged vessels on international voyages.,USCG,,,,"(a) Owners of U.S.-flagged vessels on international voyages must have Cargo Securing Manuals (CSMs) approved in accordance with this part. (1) An applicant for CSM approval may be the owner or operator of the vessel, or a person acting on the owner or operator's behalf. (2) The Commandant is responsible for overseeing and managing the review and approval of CSM approval authority applications and providing an up-to-date list of organizations authorized to act under this subpart, which is available at http://www.uscg.mil/hq/cg5/cg522/cg5222, or by requesting it in writing from the Commandant and enclosing a self-addressed, stamped envelope. (3) The applicant must submit two dated copies of a CSM that meets the requirements of this subpart to a CSM approval authority for review and approval. If any amendments are submitted, they must be dated. The CSM must include a “change page” document to ensure continuous documentation of amendments made and the dates they were completed. (4) The approval authority will retain one copy of the CSM for its records. (b) If the approval authority completes the review process and approves the CSM, the approval authority will provide a CSM approval letter on its letterhead, containing— (1) Date of CSM approval; (2) A subject line reading: “APPROVAL OF CARGO SECURING MANUAL (AMENDMENT—if applicable) FOR THE M/V ____, OFFICIAL NUMBER ____”; (3) The following statement: “This is to certify that the Cargo Securing Manual (Amendment—if applicable) dated ____ for the M/V ____, Official Number ____, has been approved on behalf of the United States. The Cargo Securing Manual (Amendment—if applicable) was reviewed for compliance with Maritime Safety Committee Circular 1353 (MSC.1/Circ. 1353/Rev.1) for content, and correctness of the calculations on which the approval is based. This approval letter is to be kept with the Cargo Securing Manual, as proof of compliance with regulations VI/5.6 and VII5 of the 2004 amendments to the International Convention for the Safety of Life at Sea (SOLAS) 1974.”; (4) Signature of the approval authority official responsible for review and approval of the CSM; and (5) The approval authority's seal or stamp. (c) If the approval authority completes the review process and disapproves the CSM, the approval authority will provide a letter on its letterhead, containing— (1) Date of CSM disapproval; and (2) Explanation of why the CSM was disapproved and what the submitter must do to correct deficiencies. (d) The submitter of a disapproved CSM may resubmit the CSM with amendments for further review, either to correct deficiencies noted by the approval authority or to expand the CSM to fully meet the requirements of this part. (e) The original copy of the CSM approval letter must be kept with the approved CSM and its amendments, together with supporting documents and calculations used in granting the approval, on board the vessel for review by Coast Guard personnel upon request." 33:33:1.0.1.6.48.1.26.8,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.205 Requirements for amending an approved cargo securing manual (CSM).,USCG,,,,"Resubmission and re-approval by a CSM approval authority are required after any of the following events occurs: (a) Reconfiguration of a vessel from one type of cargo carriage to another ( e.g., a general break-bulk cargo vessel reconfigured to a container or a roll-on/roll-off vessel). (b) Reconfiguration or replacement of 15 percent or more of the vessel's fixed cargo securing or tie-down systems with different types of devices or systems. (c) Replacement of 15 percent or more of the vessel's portable cargo securing devices, with different types of devices for securing the cargo not already used aboard the vessel ( e.g., wire lashings replaced with turnbuckles or chains)." 33:33:1.0.1.6.48.1.26.9,33,Navigation and Navigable Waters,I,F,97,"PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES",A,Subpart A—Cargo Securing Manuals,,§ 97.210 Appeals.,USCG,,,,"(a) A vessel owner or operator, or person acting on their behalf, who disagrees with a decision of a CSM approval authority may submit a written appeal to the approval authority requesting reconsideration of information in dispute. Within 30 days of receiving the appeal, the approval authority must provide the submitter with a final written ruling on the request, with a copy to the Commandant. (b) A submitter who is dissatisfied with the approval authority's final written ruling may appeal directly to the Commandant. The appeal must be made in writing and include the documentation and supporting evidence the submitter wants to be considered, and may ask the Commandant to stay the effect of the appealed decision while it is under review by the Commandant. (c) The Commandant will make a decision on the appeal and send a formal response to the submitter and a copy to the approval authority. The Commandant's decision will constitute final agency action on the appeal request." 34:34:1.1.1.1.30.1.113.1,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.101 To what does this policy apply?,ED,,,"[82 FR 7272, Jan. 19, 2017, as amended at 83 FR 28516, June 19, 2018]","(a) Except as detailed in § 97.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy. (b) [Reserved] (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report. 62 62 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report. Washington, DC: U.S. Department of Health and Human Services. 1979. (d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy comply with some or all of the requirements of this policy. (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects. (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. (g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that provide additional protections to human subjects of research. (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in department or agency procedures. (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy, provided the alternative procedures to be followed are consistent with the principles of the Belmont Report. 63 Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office, or to the equivalent office within the appropriate Federal department or agency, and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures. The waiver notice must include a statement that identifies the conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles of the Belmont Report. 63 Id. (j) Federal guidance on the requirements of this policy shall be issued only after consultation, for the purpose of harmonization (to the extent appropriate), with other Federal departments and agencies that have adopted this policy, unless such consultation is not feasible. (k) [Reserved] (l) Pre-2018 Requirements. Compliance dates and transition provisions: (1) For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations. (2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for § 97.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to § 97.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under § 97.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section determines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: ( 1 ) Section 97.102(l) of the 2018 Requirements (definition of research) (instead of § 97.102(d) of the pre-2018 Requirements); ( 2 ) Section 97.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of § 97.103(f) of the pre-2018 Requirements); and ( 3 ) Section 97.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of § 97.103(b), as related to the requirement for continuing review, and in addition to § 97.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019; (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. (m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other dissimilar circumstances." 34:34:1.1.1.1.30.1.113.10,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.111 Criteria for IRB approval of research.,ED,,,,"(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research ( e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, § 97.116. (5) Informed consent will be appropriately documented or appropriately waived in accordance with § 97.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data. (ii) [Reserved] (8) For purposes of conducting the limited IRB review required by § 97.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of § 97.116(a)(1)-(4), (a)(6), and (d); (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with § 97.117; and (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects." 34:34:1.1.1.1.30.1.113.11,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.112 Review by Institution,ED,,,,"Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB." 34:34:1.1.1.1.30.1.113.12,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.113 Suspension or Termination of IRB Approval of Research.,ED,,,,"An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head." 34:34:1.1.1.1.30.1.113.13,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.114 Cooperative Research.,ED,,,,"(a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. (2) The following research is not subject to this provision: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort." 34:34:1.1.1.1.30.1.113.14,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.115 IRB Records.,ED,,,,"(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in § 97.109(f)(1). (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described in § 97.108(a)(2). (6) Written procedures for the IRB in the same detail as described in § 97.108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as required by § 97.116(c)(5). (8) The rationale for an expedited reviewer's determination under § 97.110(b)(1)(i) that research appearing on the expedited review list described in § 97.110(a) is more than minimal risk. (9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in § 97.103(e). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at reasonable times and in a reasonable manner." 34:34:1.1.1.1.30.1.113.15,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.116 General Requirements for Informed Consent.,ED,,,,"(a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is described in paragraph (f) of this section. Except as provided elsewhere in this policy: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative. (2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence. (3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. (4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. (5) Except for broad consent obtained in accordance with paragraph (d) of this section: (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. (ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. (6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others that may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and (9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or (ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. (c) Additional elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject; (6) The approximate number of subjects involved in the study; (7) A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; (8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and (9) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing ( i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). (d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in paragraphs (b) and (c) of this section. If the subject or the legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject's legally authorized representative: (1) The information required in paragraphs (b)(2), (b)(3), (b)(5), and (b)(8) and, when appropriate, (c)(7) and (9) of this section; (2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted; (3) A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens; (4) A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite); (5) Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies; (6) Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and (7) An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm. (e) Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials —(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (e)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section. (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: (i) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (A) Public benefit or service programs; (B) Procedures for obtaining benefits or services under those programs; (C) Possible changes in or alternatives to those programs or procedures; or (D) Possible changes in methods or levels of payment for benefits or services under those programs; and (ii) The research could not practicably be carried out without the waiver or alteration. (f) General waiver or alteration of consent —(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section. (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: (i) The research involves no more than minimal risk to the subjects; (ii) The research could not practicably be carried out without the requested waiver or alteration; (iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; (iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and (v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. (g) Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met: (1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or (2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens. (h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms. (2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site ( e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. (i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be legally effective. (j) Emergency medical care. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe)." 34:34:1.1.1.1.30.1.113.16,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.117 Documentation of informed consent.,ED,,,,"(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. A written copy shall be given to the person signing the informed consent form. (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following: (1) A written informed consent form that meets the requirements of § 97.116. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative. (2) A short form written informed consent form stating that the elements of informed consent required by § 97.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by § 97.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form. (c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following: (i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; (ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or (iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. (2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research." 34:34:1.1.1.1.30.1.113.17,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.118 Applications and proposals lacking definite plans for involvement of human subjects.,ED,,,,"Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 97.101(i) or exempted under § 97.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research." 34:34:1.1.1.1.30.1.113.18,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.119 Research undertaken without the intention of involving human subjects.,ED,,,,"Except for research waived under § 97.101(i) or exempted under § 97.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component." 34:34:1.1.1.1.30.1.113.19,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.,ED,,,,"(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one." 34:34:1.1.1.1.30.1.113.2,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.102 Definitions for purposes of this policy.,ED,,,,"(a) Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (c) Department or agency head means the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated. (d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates ( e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. (3) Interaction includes communication or interpersonal contact between investigator and subject. (4) Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public ( e.g., a medical record). (5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. (6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. (7) Federal departments or agencies implementing this policy shall: (i) Upon consultation with appropriate experts (including experts in data matching and re-identification), reexamine the meaning of “identifiable private information,” as defined in paragraph (e)(5) of this section, and “identifiable biospecimen,” as defined in paragraph (e)(6) of this section. This reexamination shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. If appropriate and permitted by law, such Federal departments and agencies may alter the interpretation of these terms, including through the use of guidance. (ii) Upon consultation with appropriate experts, assess whether there are analytic technologies or techniques that should be considered by investigators to generate “identifiable private information,” as defined in paragraph (e)(5) of this section, or an “identifiable biospecimen,” as defined in paragraph (e)(6) of this section. This assessment shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. Any such technologies or techniques will be included on a list of technologies or techniques that produce identifiable private information or identifiable biospecimens. This list will be published in the Federal Register after notice and an opportunity for public comment. The Secretary, HHS, shall maintain the list on a publicly accessible Web site. (f) Institution means any public or private entity, or department or agency (including federal, state, and other agencies). (g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy. (h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. (i) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research. (j) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (k) Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. (l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research: (1) Scholarly and journalistic activities ( e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. (2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium ( e.g., paper) or in an electronic format." 34:34:1.1.1.1.30.1.113.20,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.121 [Reserved],ED,,,, 34:34:1.1.1.1.30.1.113.21,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.122 Use of Federal funds.,ED,,,,Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. 34:34:1.1.1.1.30.1.113.22,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.123 Early termination of research support: Evaluation of applications and proposals.,ED,,,,"(a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation)." 34:34:1.1.1.1.30.1.113.23,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.124 Conditions.,ED,,,,With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects. 34:34:1.1.1.1.30.1.113.3,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.,ED,,,,"(a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under § 97.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification is required by § 97.103(d)). (b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes. (c) The department or agency head may limit the period during which any assurance shall remain effective or otherwise condition or restrict the assurance. (d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under § 97.101(i) or exempted under § 97.104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB. (e) For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to § 97.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy ( e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol)." 34:34:1.1.1.1.30.1.113.4,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.104 Exempt research.,ED,,,,"(a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category. (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners. (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D. (c) [Reserved] (d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 97.111(a)(7). (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 97.111(a)(7). (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. (4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. (5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. (ii) [Reserved] (6) Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § 97.111(a)(8). (8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with § 97.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § 97.117; (iii) An IRB conducts a limited IRB review and makes the determination required by § 97.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results." 34:34:1.1.1.1.30.1.113.5,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§§ 97-97.106 [Reserved],ED,,,, 34:34:1.1.1.1.30.1.113.6,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.107 IRB membership.,ED,,,,"(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB." 34:34:1.1.1.1.30.1.113.7,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.108 IRB functions and operations.,ED,,,,"(a) In order to fulfill the requirements of this policy each IRB shall: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties; (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant; (3) Establish and follow written procedures for: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. (4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval. (b) Except when an expedited review procedure is used (as described in § 97.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting." 34:34:1.1.1.1.30.1.113.8,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,§ 97.109 IRB review of research.,ED,,,,"(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 97.104 for which limited IRB review is a condition of exemption (under § 97.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)). (b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with § 97.116. The IRB may require that information, in addition to that specifically mentioned in § 97.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 97.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in § 97.109(f). (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: (i) Research eligible for expedited review in accordance with § 97.110; (ii) Research reviewed by the IRB in accordance with the limited IRB review described in § 97.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8); (iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. (2) [Reserved] (g) An IRB shall have authority to observe or have a third party observe the consent process and the research." 34:34:1.1.1.1.30.1.113.9,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,A,Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects),,"§ 97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.",ED,,,,"(a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal departments and agencies and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited review procedure to review the following: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk; (ii) Minor changes in previously approved research during the period for which approval is authorized; or (iii) Research for which limited IRB review is a condition of exemption under § 97.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). (2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in § 97.108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure." 34:34:1.1.1.1.30.3.113.1,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.401 To what do these regulations apply?,ED,,,,"(a) This subpart applies to all research involving children as subjects conducted or supported by the Department of Education. (1) This subpart applies to research conducted by Department employees. (2) This subpart applies to research conducted or supported by the Department of Education outside the United States, but in appropriate circumstances the Secretary may, under § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this subpart for that research. (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption in § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator or investigators do not participate in the activities being observed. (c) The exceptions, additions, and provisions for waiver as they appear in § 97.101(c) through (i) are applicable to this subpart." 34:34:1.1.1.1.30.3.113.2,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.402 Definitions.,ED,,,,"The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this subpart: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. (d) Parent means a child's biological or adoptive parent. (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care." 34:34:1.1.1.1.30.3.113.3,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.403 IRB duties.,ED,,,,"In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research that satisfies the conditions of all applicable sections of this subpart." 34:34:1.1.1.1.30.3.113.4,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.404 Research not involving greater than minimal risk.,ED,,,,"ED conducts or funds research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in § 97.408." 34:34:1.1.1.1.30.3.113.5,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.,ED,,,,"ED conducts or funds research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that— (a) The risk is justified by the anticipated benefit to the subjects; (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 97.408." 34:34:1.1.1.1.30.3.113.6,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,"§ 97.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.",ED,,,,"ED conducts or funds research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that— (a) The risk represents a minor increase over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in § 97.408." 34:34:1.1.1.1.30.3.113.7,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,"§ 97.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.",ED,,,,"ED conducts or funds research that the IRB does not believe meets the requirements of § 97.404, § 97.405, or § 97.406 only if— (a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either that— (1) The research in fact satisfies the conditions of § 97.404, § 97.405, or § 97.406, as applicable; or (2)(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; (ii) The research will be conducted in accordance with sound ethical principles; and (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 97.408." 34:34:1.1.1.1.30.3.113.8,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.408 Requirements for permission by parents or guardians and for assent by children.,ED,,,,"(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, if in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even if the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with § 97.116. (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by § 97.116, that adequate provisions are made for soliciting the permission of each child's parent(s) or guardian(s). If parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under § 97.404 or § 97.405. If research is covered by §§ 97.406 and 97.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the child. (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition. (d) Permission by parents or guardians must be documented in accordance with and to the extent required by § 97.117. (e) If the IRB determines that assent is required, it shall also determine whether and how assent must be documented." 34:34:1.1.1.1.30.3.113.9,34,Education,,,97,PART 97—PROTECTION OF HUMAN SUBJECTS,D,Subpart D—Additional ED Protections for Children Who Are Subjects in Research,,§ 97.409 Wards.,ED,,,,"(a) Children who are wards of the State or any other agency, institution, or entity may be included in research approved under § 97.406 or § 97.407 only if that research is— (1) Related to their status as wards; or (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator or investigators, or the guardian organization." 40:40:23.0.1.1.1.1.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,§ 97.1 Purpose.,EPA,,,,"This part establishes general provisions and the applicability, permitting, allowance, excess emissions, monitoring, and opt-in provisions for the federal NO X Budget Trading Program, under section 126 of the CAA and § 52.34 of this chapter, as a means of mitigating the interstate transport of ozone and nitrogen oxides, an ozone precursor." 40:40:23.0.1.1.1.1.1.2,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,§ 97.2 Definitions.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 69 FR 21645, Apr. 21, 2004]","The terms used in this part shall have the meanings set forth in this section as follows: Account number means the identification number given by the Administrator to each NO X Allowance Tracking System account. Acid Rain emissions limitation means, as defined in § 72.2 of this chapter, a limitation on emissions of sulfur dioxide or nitrogen oxides under the Acid Rain Program under title IV of the Clean Air Act. Administrator means the Administrator of the United States Environmental Protection Agency or the Administrator's duly authorized representative. Allocate or allocation means, with regard to NO X allowances, the determination by the Administrator of the number of NO X allowances to be initially credited to a NO X Budget unit or an allocation set-aside. Automated data acquisition and handling system or DAHS means that component of the CEMS, or other emissions monitoring system approved for use under subpart H of this part, designed to interpret and convert individual output signals from pollutant concentration monitors, flow monitors, diluent gas monitors, and other component parts of the monitoring system to produce a continuous record of the measured parameters in the measurement units required by subpart H of this part. Boiler means an enclosed fossil or other fuel-fired combustion device used to produce heat and to transfer heat to recirculating water, steam, or other medium. Clean Air Act means the Clean Air Act, 42 U.S.C. 7401 et seq. Combined cycle system means a system comprised of one or more combustion turbines, heat recovery steam generators, and steam turbines configured to improve overall efficiency of electricity generation or steam production. Combustion turbine means an enclosed fossil or other fuel-fired device that is comprised of a compressor, a combustor, and a turbine, and in which the flue gas resulting from the combustion of fuel in the combustor passes through the turbine, rotating the turbine. Commence commercial operation means, with regard to a unit that serves a generator, to have begun to produce steam, gas, or other heated medium used to generate electricity for sale or use, including test generation. Except as provided in § 97.4(b), § 97.5, or subpart I of this part, for a unit that is a NO X Budget unit under § 97.4(a) on the date the unit commences commercial operation, such date shall remain the unit's date of commencement of commercial operation even if the unit is subsequently modified, reconstructed, or repowered. Except as provided in § 97.4(b), § 97.5, or subpart I of this part, for a unit that is not a NO X Budget unit under § 97.4(a) on the date the unit commences commercial operation, the date the unit becomes a NO X Budget unit under § 97.4(a) shall be the unit's date of commencement of commercial operation. Commence operation means to have begun any mechanical, chemical, or electronic process, including, with regard to a unit, start-up of a unit's combustion chamber. Except as provided in § 97.4(b), § 97.5, or subpart I of this part for a unit that is a NO X Budget unit under § 97.4(a) on the date of commencement of operation, such date shall remain the unit's date of commencement of operation even if the unit is subsequently modified, reconstructed, or repowered. Except as provided in § 97.4(b), § 97.5, or subpart I of this part, for a unit that is not a NO X Budget unit under § 97.4(a) on the date of commencement of operation, the date the unit becomes a NO X Budget unit under § 97.4(a) shall be the unit's date of commencement of operation. Common stack means a single flue through which emissions from two or more units are exhausted. Compliance account means a NO X Allowance Tracking System account, established by the Administrator for a NO X Budget unit under subpart F of this part, in which the NO X allowance allocations for the unit are initially recorded and in which are held NO X allowances available for use by the unit for a control period for the purpose of meeting the unit's NO X Budget emissions limitation. Continuous emission monitoring system or CEMS means the equipment required under subpart H of this part to sample, analyze, measure, and provide, by means of readings taken at least once every 15 minutes (using an automated data acquisition and handling system (DAHS)), a permanent record of nitrogen oxides (NO X ) emissions, stack gas volumetric flow rate or stack gas moisture content (as applicable), in a manner consistent with part 75 of this chapter. The following are the principal types of continuous emission monitoring systems required under subpart H of this part: (1) A flow monitoring system, consisting of a stack flow rate monitor and an automated DAHS. A flow monitoring system provides a permanent, continuous record of stack gas volumetric flow rate, in units of standard cubic feet per hour (scfh); (2) A nitrogen oxides concentration monitoring system, consisting of a NO X pollutant concentration monitor and an automated DAHS. A NO X concentration monitoring system provides a permanent, continuous record of NO X emissions in units of parts per million (ppm); (3) A nitrogen oxides emission rate (or NO X -diluent) monitoring system, consisting of a NO X pollutant concentration monitor, a diluent gas (CO 2 or O 2 ) monitor, and an automated DAHS. A NO X concentration monitoring system provides a permanent, continuous record of: NO X concentration in units of parts per million (ppm), diluent gas concentration in units of percent O 2 or CO 2 (percent O 2 or CO 2 ), and NO X emission rate in units of pounds per million British thermal units (lb/mmBtu); and (4) A moisture monitoring system, as defined in § 75.11(b)(2) of this chapter. A moisture monitoring system provides a permanent, continuous record of the stack gas moisture content, in units of percent H 2 O (percent H 2 O). Control period means the period beginning May 1 of a year and ending on September 30 of the same year, inclusive. Electricity for sale under firm contract to the grid means electricity for sale where the capacity involved is intended to be available at all times during the period covered by a guaranteed commitment to deliver, even under adverse conditions. Emissions means air pollutants exhausted from a unit or source into the atmosphere, as measured, recorded, and reported to the Administrator by the NO X authorized account representative and as determined by the Administrator in accordance with subpart H of this part. Energy Information Administration means the Energy Information Administration of the United States Department of Energy. Excess emissions means any tonnage of nitrogen oxides emitted by a NO X Budget unit during a control period that exceeds the NO X Budget emissions limitation for the unit. Fossil fuel means natural gas, petroleum, coal, or any form of solid, liquid, or gaseous fuel derived from such material. Fossil fuel fired means, with regard to a unit: (1) For units that commenced operation before January 1, 1996, the combustion of fossil fuel, alone or in combination with any other fuel, where fossil fuel actually combusted comprises more than 50 percent of the annual heat input on a Btu basis during 1995, or, if a unit had no heat input in 1995, during the last year of operation of the unit prior to 1995; (2) For units that commenced operation on or after January 1, 1996 and before January 1, 1997, the combustion of fossil fuel, alone or in combination with any other fuel, where fossil fuel actually combusted comprises more than 50 percent of the annual heat input on a Btu basis during 1996; or (3) For units that commence operation on or after January 1, 1997: (i) The combination of fossil fuel, alone or in combustion with any other fuel, where fossil fuel actually combusted comprises more than 50 percent of the annual heat input on a Btu basis during any year; or (ii) The combination of fossil fuel, alone or in combination with any other fuel, where fossil fuel is projected to comprise more than 50 percent of the annual heat input on a Btu basis during any year, provided that the unit shall be “fossil fuel-fired” as of the date, during such year, on which the unit begins combusting fossil fuel. General account means a NO X Allowance Tracking System account, established under subpart F of this part, that is not a compliance account or an overdraft account. Generator means a device that produces electricity. Heat input means, with regard to a specified period to time, the product (in mmBtu/time) of the gross calorific value of the fuel (in Btu/lb) divided by 1,000,000 Btu/mmBtu and multiplied by the fuel feed rate into a combustion device (in lb of fuel/time), as measured, recorded, and reported to the Administrator by the NO X authorized account representative and as determined by the Administrator in accordance with subpart H of this part. Heat input does not include the heat derived from preheated combustion air, recirculated flue gases, or exhaust from other sources. Heat input rate means the amount of heat input (in mmBtu) divided by unit operating time (in hr) or, with regard to a specific fuel, the amount of heat input attributed to the fuel (in mmBtu) divided by the unit operating time (in hr) during which the unit combusts the fuel. Life-of-the-unit, firm power contractual arrangement means a unit participation power sales agreement under which a utility or industrial customer reserves, or is entitled to receive, a specified amount or percentage of nameplate capacity and associated energy from any specified unit and pays its proportional amount of such unit's total costs, pursuant to a contract: (1) For the life of the unit; (2) For a cumulative term of no less than 30 years, including contracts that permit an election for early termination; or (3) For a period equal to or greater than 25 years or 70 percent of the economic useful life of the unit determined as of the time the unit is built, with option rights to purchase or release some portion of the nameplate capacity and associated energy generated by the unit at the end of the period. Maximum design heat input means the ability of a unit to combust a stated maximum amount of fuel per hour (in mmBtu/hr) on a steady state basis, as determined by the physical design and physical characteristics of the unit. Maximum potential hourly heat input means an hourly heat input (in mmBtu/hr) used for reporting purposes when a unit lacks certified monitors to report heat input. If the unit intends to use appendix D of part 75 of this chapter to report heat input, this value should be calculated, in accordance with part 75 of this chapter, using the maximum fuel flow rate and the maximum gross calorific value. If the unit intends to use a flow monitor and a diluent gas monitor, this value should be reported, in accordance with part 75 of this chapter, using the maximum potential flowrate and either the maximum carbon dioxide concentration (in percent CO 2 ) or the minimum oxygen concentration (in percent O2). Maximum potential NO X emission rate means the emission rate of nitrogen oxides (in lb/mmBtu) calculated in accordance with section 3 of appendix F of part 75 of this chapter, using the maximum potential concentration of NO X under section 2 of appendix A of part 75 of this chapter, and either the maximum oxygen concentration (in percent O2) or the minimum carbon dioxide concentration (in percent CO 2 ), under all operating conditions of the unit except for unit start up, shutdown, and upsets. Maximum rated hourly heat input means a unit specific maximum hourly heat input (in mmBtu/hr) which is the higher of the manufacturer's maximum rated hourly heat input or the highest observed hourly heat input. Monitoring system means any monitoring system that meets the requirements of subpart H of this part, including a continuous emissions monitoring system, an excepted monitoring system, or an alternative monitoring system. Most stringent State or Federal NO X emissions limitation means the lowest NO X emissions limitation (in lb/mmBtu) that is applicable to the unit under State or Federal law, regardless of the averaging period to which the emissions limitation applies. Nameplate capacity means the maximum electrical generating output (in MWe) that a generator can sustain over a specified period of time when not restricted by seasonal or other deratings as measured in accordance with the United States Department of Energy standards. Non-title V permit means a federally enforceable permit administered by the permitting authority pursuant to the Clean Air Act and regulatory authority under the Clean Air Act, other than title V of the Clean Air Act and part 70 or 71 of this chapter. NO X allowance means a limited authorization by the Administrator under the NO X Budget Trading Program to emit up to one ton of nitrogen oxides during the control period of the specified year or of any year thereafter, except as provided under § 97.54(f). No provision of the NO X Budget Trading Program, the NO X Budget permit application, the NO X Budget permit, or an exemption under § 97.4(b) or § 97.5 and no provision of law shall be construed to limit the authority of the United States to terminate or limit such authorization, which does not constitute a property right. For purposes of all sections of this part except § 97.40, § 97.41, § 97.42, § 97.43, or § 97.88, “NO X allowance” also includes an authorization to emit up to one ton of nitrogen oxides during the control period of the specified year or of any year thereafter by the permitting authority or the Administrator in accordance with a State NO X Budget Trading Program established, and approved and administered by the Administrator, pursuant to § 51.121 of this chapter. NO X allowance deduction or deduct NO X allowances means the permanent withdrawal of NO X allowances by the Administrator from a NO X Allowance Tracking System compliance account or overdraft account to account for the number of tons of NO X emissions from a NO X Budget unit for a control period, determined in accordance with subparts H and F of this part, or for any other NO X allowance withdrawal requirement under this part. NO X Allowance Tracking System means the system by which the Administrator records allocations, deductions, and transfers of NO X allowances under the NO X Budget Trading Program. NO X Allowance Tracking System account means an account in the NO X Allowance Tracking System established by the Administrator for purposes of recording the allocation, holding, transferring, or deducting of NO X allowances. NO X allowance transfer deadline means midnight of November 30 or, if November 30 is not a business day, midnight of the first business day thereafter and is the deadline by which NO X allowances must be submitted for recordation in a NO X Budget unit's compliance account, or the overdraft account of the source where the unit is located, in order to meet the unit's NO X Budget emissions limitation for the control period immediately preceding such deadline. NO X allowances held or hold NO X allowances means the NO X allowances recorded by the Administrator, or submitted to the Administrator for recordation, in accordance with subparts F and G of this part, in a NO X Allowance Tracking System account. NO X authorized account representative means, for a NO X Budget source or NO X Budget unit at the source, the natural person who is authorized by the owners and operators of the source and all NO X Budget units at the source, in accordance with subpart B of this part, to represent and legally bind each owner and operator in matters pertaining to the NO X Budget Trading Program or, for a general account, the natural person who is authorized, in accordance with subpart F of this part, to transfer or otherwise dispose of NO X allowances held in the general account. NO X Budget emissions limitation means, for a NO X Budget unit, the tonnage equivalent of the NO X allowances available for compliance deduction for the unit under § 97.54(a), (b), (e), and (f) in a control period adjusted by deductions of such NO X allowances to account for actual heat input under § 97.42(e) for the control period or to account for excess emissions for a prior control period under § 97.54(d) or to account for withdrawal from the NO X Budget Trading Program, or for a change in regulatory status, of a NO X Budget opt-in unit under § 97.86 or § 97.87. NO X Budget opt-in permit means a NO X Budget permit covering a NO X Budget opt-in unit. NO X Budget opt-in unit means a unit that has been elected to become a NO X Budget unit under the NO X Budget Trading Program and whose NO X Budget opt-in permit has been issued and is in effect under subpart I of this part. NO X Budget permit means the legally binding and federally enforceable written document, or portion of such document, issued by the permitting authority under this part, including any permit revisions, specifying the NO X Budget Trading Program requirements applicable to a NO X Budget source, to each NO X Budget unit at the NO X Budget source, and to the owners and operators and the NO X authorized account representative of the NO X Budget source and each NO X Budget unit. NO X Budget source means a source that includes one or more NO X Budget units. NO X Budget Trading Program means a multistate nitrogen oxides air pollution control and emission reduction program established by the Administrator in accordance with this part and pursuant to § 52.34 of this chapter, as a means of mitigating the interstate transport of ozone and nitrogen oxides, an ozone precursor. NO X Budget unit means a unit that is subject to the NO X Budget emissions limitation under § 97.4(a) or § 97.80. Operating means, with regard to a unit under §§ 97.22(d)(2) and 97.80, having documented heat input for more than 876 hours in the 6 months immediately preceding the submission of an application for an initial NO X Budget permit under § 97.83(a). The unit's documented heat input will be determined in accordance with part 75 of this chapter if the unit was otherwise subject to the requirements of part 75 of this chapter during that 6-month period or will be based on the best available data reported to the Administrator for the unit if the unit was not otherwise subject to the requirements of part 75 of this chapter during that 6-month period. Operator means any person who operates, controls, or supervises a NO X Budget unit, a NO X Budget source, or a unit for which an application for a NO X Budget opt-in permit under § 97.83 is submitted and not denied or withdrawn and shall include, but not be limited to, any holding company, utility system, or plant manager of such a unit or source. Opt-in means to be elected to become a NO X Budget unit under the NO X Budget Trading Program through a final, effective NO X Budget opt-in permit under subpart I of this part. Overdraft account means the NO X Allowance Tracking System account, established by the Administrator under subpart F of this part, for each NO X Budget source where there are two or more NO X Budget units. Owner means any of the following persons: (1) Any holder of any portion of the legal or equitable title in a NO X Budget unit or in a unit for which an application for a NO X Budget opt-in permit under § 97.83 is submitted and not denied or withdrawn; or (2) Any holder of a leasehold interest in a NO X Budget unit or in a unit for which an application for a NO X Budget opt-in permit under § 97.83 is submitted and not denied or withdrawn; or (3) Any purchaser of power from a NO X Budget unit or from a unit for which an application for a NO X Budget opt-in permit under § 97.83 is submitted and not denied or withdrawn under a life-of-the-unit, firm power contractual arrangement. However, unless expressly provided for in a leasehold agreement, owner shall not include a passive lessor, or a person who has an equitable interest through such lessor, whose rental payments are not based, either directly or indirectly, upon the revenues or income from the NO X Budget unit or the unit for which an application for a NO X Budget opt-in permit under § 97.83 is submitted and not denied or withdrawn; or (4) With respect to any general account, any person who has an ownership interest with respect to the NO X allowances held in the general account and who is subject to the binding agreement for the NO X authorized account representative to represent that person's ownership interest with respect to the NO X allowances. Percent monitor data availability means, for purposes of § 97.43 (a)(1) and § 97.84(b), total unit operating hours for which quality-assured data were recorded under subpart H of this part in a control period, divided by the total number of unit operating hours in the control period, and multiplied by 100 percent. Permitting authority means the State air pollution control agency, local agency, other State agency, or other agency authorized by the Administrator to issue or revise permits to meet the requirements of the NO X Budget Trading Program in accordance with subpart C of this part. Potential electrical output capacity means 33 percent of a unit's maximum design heat input. Receive or receipt of means, when referring to the permitting authority or the Administrator, to come into possession of a document, information, or correspondence (whether sent in writing or by authorized electronic transmission), as indicated in an official correspondence log, or by a notation made on the document, information, or correspondence, by the permitting authority or the Administrator in the regular course of business. Recordation, record, or recorded means, with regard to NO X allowances, the movement of NO X allowances by the Administrator from one NO X Allowance Tracking System account to another, for purposes of allocation, transfer, or deduction. Reference method means any direct test method of sampling and analyzing for an air pollutant as specified in appendix A of part 60 of this chapter. Serial number means, when referring to NO X allowances, the unique identification number assigned to each NO X allowance by the Administrator, under § 97.53(c). Source means any governmental, institutional, commercial, or industrial structure, installation, plant, building, or facility that emits or has the potential to emit any regulated air pollutant under the Clean Air Act. For purposes of section 502(c) of the Clean Air Act, a “source,” including a “source” with multiple units, shall be considered a single “facility.” State means one of the 48 contiguous States or a portion thereof or the District of Columbia that is specified in § 52.34 of this chapter and in which are located units for which the Administrator makes an effective finding under § 52.34 of this chapter. Submit or serve means to send or transmit a document, information, or correspondence to the person specified in accordance with the applicable regulation: (1) In person; (2) By United States Postal Service; or (3) By other means of dispatch or transmission and delivery. Compliance with any “submission,” “service,” or “mailing” deadline shall be determined by the date of dispatch, transmission, or mailing and not the date of receipt. Title V operating permit means a permit issued under title V of the Clean Air Act and part 70 or part 71 of this chapter. Title V operating permit regulations means the regulations that the Administrator has approved or issued as meeting the requirements of title V of the Clean Air Act and part 70 or 71 of this chapter. Ton or tonnage means any “short ton” (i.e., 2,000 pounds). For the purpose of determining compliance with the NO X Budget emissions limitation, total tons for a control period shall be calculated as the sum of all recorded hourly emissions (or the tonnage equivalent of the recorded hourly emissions rates) in accordance with subpart H of this part, with any remaining fraction of a ton equal to or greater than 0.50 ton deemed to equal one ton and any fraction of a ton less than 0.50 ton deemed to equal zero tons. Unit means a fossil fuel-fired stationary boiler, combustion turbine, or combined cycle system. Unit operating day means a calendar day in which a unit combusts any fuel. Unit operating hour or hour of unit operation means any hour (or fraction of an hour) during which a unit combusts any fuel." 40:40:23.0.1.1.1.1.1.3,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,"§ 97.3 Measurements, abbreviations, and acronyms.",EPA,,,,"Measurements, abbreviations, and acronyms used in this part are defined as follows: Btu-British thermal unit. CO 2 -carbon dioxide. hr-hour. kW-kilowatt electrical. kWh-kilowatt hour. lb-pounds. mmBtu-million Btu. MWe-megawatt electrical. NO X -nitrogen oxides. O 2 -oxygen. ton-2000 pounds. Btu-British thermal unit. CO 2 -carbon dioxide. hr-hour. kW-kilowatt electrical. kWh-kilowatt hour. lb-pounds. mmBtu-million Btu. MWe-megawatt electrical. NO X -nitrogen oxides. O 2 -oxygen. ton-2000 pounds." 40:40:23.0.1.1.1.1.1.4,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,§ 97.4 Applicability.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 67 FR 21529, Apr. 30, 2002; 69 FR 21645, Apr. 21, 2004]","(a) The following units in a State shall be a NO X Budget unit, and any source that includes one or more such units shall be a NO X Budget source, subject to the requirements of this part: (1)(i) For units other than cogeneration units— (A) For units commencing operation before January 1, 1997, a unit serving during 1995 or 1996 a generator— ( 1 ) With a nameplate capacity greater than 25 MWe and ( 2 ) Producing electricity for sale under a firm contract to the electric grid. (B) For units commencing operation in 1997 or 1998, a unit serving during 1997 or 1998 a generator— ( 1 ) With a nameplate capacity greater than 25 MWe and ( 2 ) Producing electricity for sale under a firm contract to the electric grid. (C) For units commencing operation on or after January 1, 1999, a unit serving at any time a generator— ( 1 ) With a nameplate capacity greater than 25 MWe and ( 2 ) Producing electricity for sale. (ii) For cogeneration units— (A) For units commencing operation before January 1, 1997, a unit serving during 1995 or 1996 a generator with a nameplate capacity greater than 25 MWe and failing to qualify as an unaffected unit under § 72.6(b)(4) of this chapter for 1995 or 1996 under the Acid Rain Program. (B) For units commencing operation in 1997 or 1998, a unit serving during 1997 or 1998 a generator with a nameplate capacity grater than 25 MWe and failing to qualify as an unaffected unit under § 72.6(b)(4) of this chapter for 1997 or 1998 under the Acid Rain Program. (C) For units commencing operation on or after January 1, 1999, a unit serving at any time a generator with a nameplate capacity greater than 25 MWe and failing to qualify as an unaffected unit under § 72.6(b)(4) of this chapter under the Acid Rain Program for any year. (2)(i) For units other than cogeneration units— (A) For units commencing operation before January 1, 1997, a unit— ( 1 ) With a maximum design heat input greater than 250 mmBtu/hr and ( 2 ) Not serving during 1995 or 1996 a generator producing electricity for sale under a firm contract to the electric grid. (B) For units commencing operation in 1997 or 1998, a unit— ( 1 ) With a maximum design heat input greater than 250 mmBtu/hr and ( 2 ) Not serving during 1997 or 1998 a generator producing electricity for sale under a firm contract to the electric grid. (C) For units commencing on or after January 1, 1999, a unit with a maximum design heat input greater than 250 mmBtu/hr: ( 1 ) At no time serving a generator producing electricity for sale; or ( 2 ) At any time serving a generator with a nameplate capacity of 25 MWe or less producing electricity for sale and with the potential to use no more than 50 percent of the potential electrical output capacity of the unit. (ii) For cogeneration units— (A) For units commencing operation before January 1, 1997, a unit with a maximum design heat input greater than 250 mmBtu/hr and qualifying as an unaffected unit under § 72.6(b)(4) of this chapter under the Acid Rain Program for 1995 and 1996. (B) For units commencing operation in 1997 or 1998, a unit with a maximum design heat input greater than 250 mmBtu/hr and qualifying as an unaffected unit under § 72.6(b)(4) under the Acid Rain Program for 1997 and 1998. (C) For units commencing on or after January 1, 1999, a unit with a maximum design heat input greater than 250 mmBtu/hr and qualifying as an unaffected unit under § 72.6(b)(4) of this chapter under the Acid Rain Program for each year. (b)(1) Notwithstanding paragraph (a) of this section, a unit under paragraph (a)(1) or (a)(2) of this section that has a federally enforceable permit that restricts the unit to combusting only natural gas or fuel oil (as defined in § 75.2 of this chapter) during a control period includes a NO X emission limitation restricting NO X emissions during a control period to 25 tons or less, and includes the special provisions in paragraph (b)(4) of this section shall be exempt from the requirements of the NO X Budget Trading Program, except for the provisions of this paragraph (b), § 97.2, § 97.3, § 97.4(a), § 97.7, and subparts E, F, and G of this part. The NO X emission limitation under this paragraph (b)(1) shall restrict NO X emissions during the control period by limiting unit operating hours. The restriction on unit operating hours shall be calculated by dividing 25 tons by the unit's maximum potential hourly NO X mass emissions, which shall equal the unit's maximum rated hourly heat input multiplied by the highest default NO X emission rate otherwise applicable to the unit under § 75.19 of this chapter. (2) The exemption under paragraph (b)(1) of this section shall become effective as follows: (i) The exemption shall become effective on the date on which the NO X emission limitation and the special provisions in the permit under paragraph (b)(1) of this section become final; or (ii) If the NO X emission limitation and the special provisions in the permit under paragraph (b)(1) of this section become final during a control period and after the first date on which the unit operates during such control period, then the exemption shall become effective on May 1 of such control period, provided that such NO X emission limitation and the special provisions apply to the unit as of such first date of operation. If such NO X emission limitation and special provisions do not apply to the unit as of such first date of operation, then the exemption under paragraph (b)(1) of this section shall become effective on October 1 of the year during which such NO X emission limitation and the special provisions become final. (3) The permitting authority that issues a federally enforceable permit under paragraph (b)(1) of this section for a unit under paragraph (a)(1) or (a)(2) of this section will provide the Administrator written notice of the issuance of such permit and, upon request, a copy of the permit. (4) Special provisions. (i) A unit exempt under paragraph (b)(1) of this section shall comply with the restriction on fuel use and unit operating hours described in paragraph (b)(1) of this section during the control period in each year. (ii) The Administrator will allocate NO X allowances to the unit under §§ 97.41(a) through (c) and 97.42(a) through (c). For each control period for which the unit is allocated NO X allowances under §§ 97.41(a) through (c) and 97.42(a) through (c): (A) The owners and operators of the unit must specify a general account, in which the Administrator will record the NO X allowances; and (B) After the Administrator records a NO X allowance allocations under §§ 97.41(a) through (c) and 97.42(a) through (c), the Administrator will deduct, from the general account under paragraph (b)(4)(ii)(A) of this section, NO X allowances that are allocated for the same or a prior control period as the NO X allowances allocated to the unit under §§ 97.41(a) through (c) and 97.42(a) through (c) and that equal the NO X emission limitation (in tons of NO X ) on which the unit's exemption under paragraph (b)(1) of this section is based. The NO X authorized account representative shall ensure that such general account contains the NO X allowances necessary for completion of such deduction. (iii) A unit exempt under this paragraph (b) shall report hours of unit operation during the control period in each year to the permitting authority by November 1 of that year. (iv) For a period of 5 years from the date the records are created, the owners and operators of a unit exempt under paragraph (b)(1) of this section shall retain, at the source that includes the unit, records demonstrating that the conditions of the federally enforceable permit under paragraph (b)(1) of this section were met, including the restriction on fuel use or unit operating hours. The 5-year period for keeping records may be extended for cause, at any time prior to the end of the period, in writing by the permitting authority or the Administrator. The owners and operators bear the burden of proof that the unit met the restriction on fuel use or unit operating hours. (v) The owners and operators and, to the extent applicable, the NO X authorized account representative of a unit exempt under paragraph (b)(1) of this section shall comply with the requirements of the NO X Budget Trading Program concerning all periods for which the exemption is not in effect, even if such requirements arise, or must be complied with, after the exemption takes effect. (vi) On the earlier of the following dates, a unit exempt under paragraph (b)(1) of this section shall lose its exemption: (A) The date on which the restriction on fuel use or unit operating hours described in paragraph (b)(1) of this section is removed from the unit's federally enforceable permit or otherwise becomes no longer applicable to any control period starting in 2004; or (B) The first date on which the unit fails to comply, or with regard to which the owners and operators fail to meet their burden of proving that the unit is complying, with the restriction on fuel use or unit operating hours described in paragraph (b)(1) of this section during any control period starting in 2004. (vii) A unit that loses its exemption in accordance with paragraph (b)(4)(vi) of this section shall be subject to the requirements of this part. For the purpose of applying permitting requirements under subpart C of this part, allocating allowances under subpart E of this part, and applying monitoring requirements under subpart H of this part, the unit shall be treated as commencing operation and, if the unit is covered by paragraph (a)(1) of this section, commencing commercial operation on the date the unit loses its exemption. (viii) A unit that is exempt under paragraph (b)(1) of this section is not eligible to be a NO X Budget opt-in unit under subpart I of this part." 40:40:23.0.1.1.1.1.1.5,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,§ 97.5 Retired unit exemption.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 67 FR 21529, Apr. 30, 2002; 69 FR 21646, Apr. 21, 2004]","(a) This section applies to any NO X Budget unit, other than a NO X Budget opt-in unit, that is permanently retired. (b)(1) Any NO X Budget unit, other than a NO X Budget opt-in unit, that is permanently retired shall be exempt from the NO X Budget Trading Program, except for the provisions of this section, § 97.2, § 97.3, § 97.4, § 97.7, and subparts E, F, and G of this part. (2) The exemption under paragraph (b)(1) of this section shall become effective the day on which the unit is permanently retired. Within 30 days of permanent retirement, the NO X authorized account representative (authorized in accordance with subpart B of this part) shall submit a statement to the permitting authority otherwise responsible for administering any NO X Budget permit for the unit. The NO X authorized account representative shall submit a copy of the statement to the Administrator. The statement shall state, in a format prescribed by the permitting authority, that the unit is permanently retired and will comply with the requirements of paragraph (c) of this section. (3) After receipt of the notice under paragraph (b)(2) of this section, the permitting authority will amend any permit covering the source at which the unit is located to add the provisions and requirements of the exemption under paragraphs (b)(1) and (c) of this section. (c) Special provisions. (1) A unit exempt under this section shall not emit any nitrogen oxides, starting on the date that the exemption takes effect. (2) The Administrator will allocate NO X allowances under subpart E of this part to a unit exempt under this section. For each control period for which the unit is allocated one or more NO X allowances, the owners and operators of the unit shall specify a general account, in which the Administrator will record such NO X allowances. (3) For a period of 5 years from the date the records are created, the owners and operators of a unit exempt under this section shall retain at the source that includes the unit, records demonstrating that the unit is permanently retired. The 5-year period for keeping records may be extended for cause, at any time prior to the end of the period, in writing by the permitting authority or the Administrator. The owners and operators bear the burden of proof that the unit is permanently retired. (4) The owners and operators and, to the extent applicable, the NO X authorized account representative of a unit exempt under this section shall comply with the requirements of the NO X Budget Trading Program concerning all periods for which the exemption is not in effect, even if such requirements arise, or must be complied with, after the exemption takes effect. (5)(i) A unit exempt under this section and located at a source that is required, or but for this exemption would be required, to have a title V operating permit shall not resume operation unless the NO X authorized account representative of the source submits a complete NO X Budget permit application under § 97.22 for the unit not less than 18 months (or such lesser time provided by the permitting authority) before the later of May 31, 2004 or the date on which the unit resumes operation. (ii) A unit exempt under this section and located at a source that is required, or but for this exemption would be required, to have a non-title V permit shall not resume operation unless the NO X authorized account representative of the source submits a complete NO X Budget permit application under § 97.22 for the unit not less than 18 months (or such lesser time provided by the permitting authority) before the later of May 31, 2004 or the date on which the unit is to first resume operation. (6) On the earlier of the following dates, a unit exempt under paragraph (b) of this section shall lose its exemption: (i) The date on which the NO X authorized account representative submits a NO X Budget permit application under paragraph (c)(5) of this section; (ii) The date on which the NO X authorized account representative is required under paragraph (c)(5) of this section to submit a NO X Budget permit application; or (iii) The date on which the unit resumes operation, if the unit is not required to submit a NO X permit application. (7) For the purpose of applying monitoring requirements under subpart H of this part, a unit that loses its exemption under this section shall be treated as a unit that commences operation or commercial operation on the first date on which the unit resumes operation. (8) A unit that is exempt under this section is not eligible to be a NO X Budget opt-in unit under subpart I of this part." 40:40:23.0.1.1.1.1.1.6,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,§ 97.6 Standard requirements.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 67 FR 21529, Apr. 30, 2002]","(a) Permit requirements. (1) The NO X authorized account representative of each NO X Budget source required to have a federally enforceable permit and each NO X Budget unit required to have a federally enforceable permit at the source shall: (i) Submit to the permitting authority a complete NO X Budget permit application under § 97.22 in accordance with the deadlines specified in § 97.21(b) and (c); (ii) Submit in a timely manner any supplemental information that the permitting authority determines is necessary in order to review a NO X Budget permit application and issue or deny a NO X Budget permit. (2) The owners and operators of each NO X Budget source required to have a federally enforceable permit and each NO X Budget unit required to have a federally enforceable permit at the source shall have a NO X Budget permit issued by the permitting authority and operate the unit in compliance with such NO X Budget permit. (3) The owners and operators of a NO X Budget source that is not otherwise required to have a federally enforceable permit are not required to submit a NO X Budget permit application, and to have a NO X Budget permit, under subpart C of this part for such NO X Budget source. (b) Monitoring requirements. (1) The owners and operators and, to the extent applicable, the NO X authorized account representative of each NO X Budget source and each NO X Budget unit at the source shall comply with the monitoring requirements of subpart H of this part. (2) The emissions measurements recorded and reported in accordance with subpart H of this part shall be used to determine compliance by the unit with the NO X Budget emissions limitation under paragraph (c) of this section. (c) Nitrogen oxides requirements. (1) The owners and operators of each NO X Budget source and each NO X Budget unit at the source shall hold NO X allowances available for compliance deductions under § 97.54(a), (b), (e), or (f) as of the NO X allowance transfer deadline, in the unit's compliance account and the source's overdraft account in an amount not less than the total NO X emissions for the control period from the unit, as determined in accordance with subpart H of this part, plus any amount necessary to account for actual heat input under § 97.42(e) for the control period or to account for excess emissions for a prior control period under § 97.54(d) or to account for withdrawal from the NO X Budget Trading Program, or a change in regulatory status, of a NO X Budget opt-in unit under § 97.86 or § 97.87. (2) Each ton of nitrogen oxides emitted in excess of the NO X Budget emissions limitation shall constitute a separate violation of this part, the Clean Air Act, and applicable State law. (3) A NO X Budget unit shall be subject to the requirements under paragraph (c)(1) of this section starting on the later of May 31, 2004 or the date on which the unit commences operation. (4) NO X allowances shall be held in, deducted from, or transferred among NO X Allowance Tracking System accounts in accordance with subparts E, F, G, and I of this part. (5) A NO X allowance shall not be deducted, in order to comply with the requirements under paragraph (c)(1) of this section, for a control period in a year prior to the year for which the NO X allowance was allocated. (6) A NO X allowance allocated by the Administrator under the NO X Budget Trading Program is a limited authorization to emit one ton of nitrogen oxides in accordance with the NO X Budget Trading Program. No provision of the NO X Budget Trading Program, the NO X Budget permit application, the NO X Budget permit, or an exemption under § 97.4(b) or § 97.5 and no provision of law shall be construed to limit the authority of the United States to terminate or limit such authorization. (7) A NO X allowance allocated by the Administrator under the NO X Budget Trading Program does not constitute a property right. (8) Upon recordation by the Administrator under subpart F or G of this part, every allocation, transfer, or deduction of a NO X allowance to or from a NO X Budget unit's compliance account or the overdraft account of the source where the unit is located is incorporated automatically in any NO X Budget permit of the NO X Budget unit. (d) Excess emissions requirements. (1) The owners and operators of a NO X Budget unit that has excess emissions in any control period shall: (i) Surrender the NO X allowances required for deduction under § 97.54(d)(1); and (ii) Pay any fine, penalty, or assessment or comply with any other remedy imposed under § 97.54(d)(3). (e) Recordkeeping and reporting requirements. (1) Unless otherwise provided, the owners and operators of the NO X Budget source and each NO X Budget unit at the source shall keep on site at the source each of the following documents for a period of 5 years from the date the document is created. This period may be extended for cause, at any time prior to the end of 5 years, in writing by the permitting authority or the Administrator. (i) The account certificate of representation under § 97.13 for the NO X authorized account representative for the source and each NO X Budget unit at the source and all documents that demonstrate the truth of the statements in the account certificate of representation; provided that the certificate and documents shall be retained on site at the source beyond such 5-year period until such documents are superseded because of the submission of a new account certificate of representation under § 97.13 changing the NO X authorized account representative. (ii) All emissions monitoring information, in accordance with subpart H of this part; provided that to the extent that subpart H of this part provides for a 3-year period for recordkeeping, the 3-year period shall apply. (iii) Copies of all reports, compliance certifications, and other submissions and all records made or required under the NO X Budget Trading Program. (iv) Copies of all documents used to complete a NO X Budget permit application and any other submission under the NO X Budget Trading Program or to demonstrate compliance with the requirements of the NO X Budget Trading Program. (2) The NO X authorized account representative of a NO X Budget source and each NO X Budget unit at the source shall submit the reports and compliance certifications required under the NO X Budget Trading Program, including those under subpart D, H, or I of this part. (f) Liability. (1) Any person who knowingly violates any requirement or prohibition of the NO X Budget Trading Program, a NO X Budget permit, or an exemption under § 97.4(b) or § 97.5 shall be subject to enforcement pursuant to applicable State or Federal law. (2) Any person who knowingly makes a false material statement in any record, submission, or report under the NO X Budget Trading Program shall be subject to criminal enforcement pursuant to the applicable State or Federal law. (3) No permit revision shall excuse any violation of the requirements of the NO X Budget Trading Program that occurs prior to the date that the revision takes effect. (4) Each NO X Budget source and each NO X Budget unit shall meet the requirements of the NO X Budget Trading Program. (5) Any provision of the NO X Budget Trading Program that applies to a NO X Budget source or the NO X authorized account representative of a NO X Budget source shall also apply to the owners and operators of such source and of the NO X Budget units at the source. (6) Any provision of the NO X Budget Trading Program that applies to a NO X Budget unit or the NO X authorized account representative of a NO X budget unit shall also apply to the owners and operators of such unit. Except with regard to the requirements applicable to units with a common stack under subpart H of this part, the owners and operators and the NO X authorized account representative of one NO X Budget unit shall not be liable for any violation by any other NO X Budget unit of which they are not owners or operators or the NO X authorized account representative and that is located at a source of which they are not owners or operators or the NO X authorized account representative. (g) Effect on other authorities. No provision of the NO X Budget Trading Program, a NO X Budget permit application, a NO X Budget permit, or an exemption under § 97.4(b) or § 97.5 shall be construed as exempting or excluding the owners and operators and, to the extent applicable, the NO X authorized account representative of a NO X Budget source or NO X Budget unit from compliance with any other provision of the applicable, approved State implementation plan, a federally enforceable permit, or the Clean Air Act." 40:40:23.0.1.1.1.1.1.7,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",A,Subpart A—NO,,§ 97.7 Computation of time.,EPA,,,,"(a) Unless otherwise stated, any time period scheduled, under the NO X Budget Trading Program, to begin on the occurrence of an act or event shall begin on the day the act or event occurs. (b) Unless otherwise stated, any time period scheduled, under the NO X Budget Trading Program, to begin before the occurrence of an act or event shall be computed so that the period ends the day before the act or event occurs. (c) Unless otherwise stated, if the final day of any time period, under the NO X Budget Trading Program, falls on a weekend or a State or Federal holiday, the time period shall be extended to the next business day." 40:40:23.0.1.1.1.10.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",J,Subpart J—Appeal Procedures,,§ 97.90 Appeal procedures.,EPA,,,"[69 FR 21648, Apr. 21, 2004]",The appeal procedures for the NO X Budget Trading Program are set forth in part 78 of this chapter. 40:40:23.0.1.1.1.11.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.101 Purpose.,EPA,,,,"This subpart and subparts BB through II set forth the general provisions and the designated representative, permitting, allowance, monitoring, and opt-in provisions for the Federal Clean Air Interstate Rule (CAIR) NO X Annual Trading Program, under section 110 of the Clean Air Act and § 52.35 of this chapter, as a means of mitigating interstate transport of fine particulates and nitrogen oxides." 40:40:23.0.1.1.1.11.1.2,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.102 Definitions.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 71 FR 74795, Dec. 13, 2006; 72 FR 59206, Oct. 19, 2007]","The terms used in this subpart and subparts BB through II shall have the meanings set forth in this section as follows: Account number means the identification number given by the Administrator to each CAIR NO X Allowance Tracking System account. Acid Rain emissions limitation means a limitation on emissions of sulfur dioxide or nitrogen oxides under the Acid Rain Program. Acid Rain Program means a multi-state sulfur dioxide and nitrogen oxides air pollution control and emission reduction program established by the Administrator under title IV of the CAA and parts 72 through 78 of this chapter. Actual weighted average NO X emission rate means, for a NO X averaging plan under § 76.11 of this chapter and for a year: (1) The sum of the products of the actual annual average NO X emission rate and actual annual heat input (as determined in accordance with part 75 of this chapter) for all units in the NO X averaging plan for the year; divided by (2) The sum of the actual annual heat input (as determined in accordance with part 75 of this chapter) for all units in the NO X averaging plan for the year. Administrator means the Administrator of the United States Environmental Protection Agency or the Administrator's duly authorized representative. Allocate or allocation means, with regard to CAIR NO X allowances, the determination by a permitting authority or the Administrator of the amount of such CAIR NO X allowances to be initially credited to a CAIR NO X unit, a new unit set-aside, or other entity. Allowance transfer deadline means, for a control period, midnight of March 1 (if it is a business day), or midnight of the first business day thereafter (if March 1 is not a business day), immediately following the control period and is the deadline by which a CAIR NO X allowance transfer must be submitted for recordation in a CAIR NO X source's compliance account in order to be used to meet the source's CAIR NO X emissions limitation for such control period in accordance with § 97.154. Alternate CAIR designated representative means, for a CAIR NO X source and each CAIR NO X unit at the source, the natural person who is authorized by the owners and operators of the source and all such units at the source, in accordance with subparts BB and II of this part, to act on behalf of the CAIR designated representative in matters pertaining to the CAIR NO X Annual Trading Program. If the CAIR NO X source is also a CAIR SO 2 source, then this natural person shall be the same person as the alternate CAIR designated representative under the CAIR SO 2 Trading Program. If the CAIR NO X source is also a CAIR NO X Ozone Season source, then this natural person shall be the same person as the alternate CAIR designated representative under the CAIR NO X Ozone Season Trading Program. If the CAIR NO X source is also subject to the Acid Rain Program, then this natural person shall be the same person as the alternate designated representative under the Acid Rain Program. If the CAIR NO X source is also subject to the Hg Budget Trading Program, then this natural person shall be the same person as the alternate Hg designated representative under the Hg Budget Trading Program. Automated data acquisition and handling system or DAHS means that component of the continuous emission monitoring system, or other emissions monitoring system approved for use under subpart HH of this part, designed to interpret and convert individual output signals from pollutant concentration monitors, flow monitors, diluent gas monitors, and other component parts of the monitoring system to produce a continuous record of the measured parameters in the measurement units required by subpart HH of this part. Biomass means— (1) Any organic material grown for the purpose of being converted to energy; (2) Any organic byproduct of agriculture that can be converted into energy; or (3) Any material that can be converted into energy and is nonmerchantable for other purposes, that is segregated from other nonmerchantable material, and that is; (i) A forest-related organic resource, including mill residues, precommercial thinnings, slash, brush, or byproduct from conversion of trees to merchantable material; or (ii) A wood material, including pallets, crates, dunnage, manufacturing and construction materials (other than pressure-treated, chemically-treated, or painted wood products), and landscape or right-of-way tree trimmings. Boiler means an enclosed fossil- or other-fuel-fired combustion device used to produce heat and to transfer heat to recirculating water, steam, or other medium. Bottoming-cycle cogeneration unit means a cogeneration unit in which the energy input to the unit is first used to produce useful thermal energy and at least some of the reject heat from the useful thermal energy application or process is then used for electricity production. CAIR authorized account representative means, with regard to a general account, a responsible natural person who is authorized, in accordance with subparts BB, FF, and II of this part, to transfer and otherwise dispose of CAIR NO X allowances held in the general account and, with regard to a compliance account, the CAIR designated representative of the source. CAIR designated representative means, for a CAIR NO X source and each CAIR NO X unit at the source, the natural person who is authorized by the owners and operators of the source and all such units at the source, in accordance with subparts BB and II of this part, to represent and legally bind each owner and operator in matters pertaining to the CAIR NO X Annual Trading Program. If the CAIR NO X source is also a CAIR SO 2 source, then this natural person shall be the same person as the CAIR designated representative under the CAIR SO 2 Trading Program. If the CAIR NO X source is also a CAIR NO X Ozone Season source, then this natural person shall be the same person as the CAIR designated representative under the CAIR NO X Ozone Season Trading Program. If the CAIR NO X source is also subject to the Acid Rain Program, then this natural person shall be the same person as the designated representative under the Acid Rain Program. If the CAIR NO X source is also subject to the Hg Budget Trading Program, then this natural person shall be the same person as the Hg designated representative under the Hg Budget Trading Program. CAIR NO X allowance means a limited authorization issued by a permitting authority or the Administrator under subpart EE of this part or § 97.188, or under provisions of a State implementation plan that are approved under § 51.123(o)(1) or (2) or (p) of this chapter, to emit one ton of nitrogen oxides during a control period of the specified calendar year for which the authorization is allocated or of any calendar year thereafter under the CAIR NO X Program. An authorization to emit nitrogen oxides that is not issued under subpart EE of this part, § 97.188, or provisions of a State implementation plan that are approved under § 51.123(o)(1) or (2) or (p) of this chapter shall not be a CAIR NO X allowance. CAIR NO X allowance deduction or deduct CAIR NO X allowances means the permanent withdrawal of CAIR NO X allowances by the Administrator from a compliance account, e.g., in order to account for a specified number of tons of total nitrogen oxides emissions from all CAIR NO X units at a CAIR NO X source for a control period, determined in accordance with subpart HH of this part, or to account for excess emissions. CAIR NO X Allowance Tracking System means the system by which the Administrator records allocations, deductions, and transfers of CAIR NO X allowances under the CAIR NO X Annual Trading Program. Such allowances will be allocated, held, deducted, or transferred only as whole allowances. CAIR NO X Allowance Tracking System account means an account in the CAIR NO X Allowance Tracking System established by the Administrator for purposes of recording the allocation, holding, transferring, or deducting of CAIR NO X allowances. CAIR NO X allowances held or hold CAIR NO X allowances means the CAIR NO X allowances recorded by the Administrator, or submitted to the Administrator for recordation, in accordance with subparts FF, GG, and II of this part, in a CAIR NO X Allowance Tracking System account. CAIR NO X Annual Trading Program means a multi-state nitrogen oxides air pollution control and emission reduction program established by the Administrator in accordance with subparts AA through II of this part and §§ 51.123(p) and 52.35 of this chapter or approved and administered by the Administrator in accordance with subparts AA through II of part 96 of this chapter and § 51.123(o)(1) or (2) of this chapter, as a means of mitigating interstate transport of fine particulates and nitrogen oxides. CAIR NO X emissions limitation means, for a CAIR NO X source, the tonnage equivalent, in NO X emissions in a control period, of the CAIR NO X allowances available for deduction for the source under § 97.154 (a) and (b) for the control period. CAIR NO X Ozone Season source means a source that is subject to the CAIR NO X Ozone Season Trading Program. CAIR NO X Ozone Season Trading Program means a multi-state nitrogen oxides air pollution control and emission reduction program established by the Administrator in accordance with subparts AAAA through IIII of this part and §§ 51.123(ee) and 52.35 of this chapter or approved and administered by the Administrator in accordance with subparts AAAA through IIII of part 96 and § 51.123(aa)(1) or (2) (and (bb)(1)), (bb)(2), or (dd) of this chapter, as a means of mitigating interstate transport of ozone and nitrogen oxides. CAIR NO X source means a source that includes one or more CAIR NO X units. CAIR NO X unit means a unit that is subject to the CAIR NO X Annual Trading Program under § 97.104 and, except for purposes of § 97.105 and subpart EE of this part, a CAIR NO X opt-in unit under subpart II of this part. CAIR permit means the legally binding and federally enforceable written document, or portion of such document, issued by the permitting authority under subpart CC of this part, including any permit revisions, specifying the CAIR NO X Annual Trading Program requirements applicable to a CAIR NO X source, to each CAIR NO X unit at the source, and to the owners and operators and the CAIR designated representative of the source and each such unit. CAIR SO 2 source means a source that is subject to the CAIR SO 2 Trading Program. CAIR SO 2 Trading Program means a multi-state sulfur dioxide air pollution control and emission reduction program established by the Administrator in accordance with subparts AAA through III of this part and §§ 51.124(r) and 52.36 of this chapter or approved and administered by the Administrator in accordance with subparts AAA through III of part 96 of this chapter and § 51.124(o)(1) or (2) of this chapter, as a means of mitigating interstate transport of fine particulates and sulfur dioxide. Certifying official means: (1) For a corporation, a president, secretary, treasurer, or vice-president or the corporation in charge of a principal business function or any other person who performs similar policy or decision-making functions for the corporation; (2) For a partnership or sole proprietorship, a general partner or the proprietor respectively; or (3) For a local government entity or State, Federal, or other public agency, a principal executive officer or ranking elected official. Clean Air Act or CAA means the Clean Air Act, 42 U.S.C. 7401, et seq. Coal means any solid fuel classified as anthracite, bituminous, subbituminous, or lignite. Coal-derived fuel means any fuel (whether in a solid, liquid, or gaseous state) produced by the mechanical, thermal, or chemical processing of coal. Coal-fired means: (1) Except for purposes of subpart EE of this part, combusting any amount of coal or coal-derived fuel, alone or in combination with any amount of any other fuel, during any year; or (2) For purposes of subpart EE of this part, combusting any amount of coal or coal-derived fuel, alone or in combination with any amount of any other fuel, during a specified year. Cogeneration unit means a stationary, fossil-fuel-fired boiler or stationary, fossil-fuel-fired combustion turbine: (1) Having equipment used to produce electricity and useful thermal energy for industrial, commercial, heating, or cooling purposes through the sequential use of energy; and (2) Producing during the 12-month period starting on the date the unit first produces electricity and during any calendar year after the calendar year in which the unit first produces electricity— (i) For a topping-cycle cogeneration unit, (A) Useful thermal energy not less than 5 percent of total energy output; and (B) Useful power that, when added to one-half of useful thermal energy produced, is not less then 42.5 percent of total energy input, if useful thermal energy produced is 15 percent or more of total energy output, or not less than 45 percent of total energy input, if useful thermal energy produced is less than 15 percent of total energy output. (ii) For a bottoming-cycle cogeneration unit, useful power not less than 45 percent of total energy input; (3) Provided that the total energy input under paragraphs (2)(i)(B) and (2)(ii) of this definition shall equal the unit's total energy input from all fuel except biomass if the unit is a boiler. Combustion turbine means: (1) An enclosed device comprising a compressor, a combustor, and a turbine and in which the flue gas resulting from the combustion of fuel in the combustor passes through the turbine, rotating the turbine; and (2) If the enclosed device under paragraph (1) of this definition is combined cycle, any associated duct burner, heat recovery steam generator, and steam turbine. Commence commercial operation means, with regard to a unit: (1) To have begun to produce steam, gas, or other heated medium used to generate electricity for sale or use, including test generation, except as provided in § 97.105 and § 97.184(h). (i) For a unit that is a CAIR NO X unit under § 97.104 on the later of November 15, 1990 or the date the unit commences commercial operation as defined in paragraph (1) of this definition and that subsequently undergoes a physical change (other than replacement of the unit by a unit at the same source), such date shall remain the date of commencement of commercial operation of the unit, which shall continue to be treated as the same unit. (ii) For a unit that is a CAIR NO X unit under § 97.104 on the later of November 15, 1990 or the date the unit commences commercial operation as defined in paragraph (1) of this definition and that is subsequently replaced by a unit at the same source ( e.g., repowered), such date shall remain the replaced unit's date of commencement of commercial operation, and the replacement unit shall be treated as a separate unit with a separate date for commencement of commercial operation as defined in paragraph (1) or (2) of this definition as appropriate. (2) Notwithstanding paragraph (1) of this definition and except as provided in § 97.105, for a unit that is not a CAIR NO X unit under § 97.104 on the later of November 15, 1990 or the date the unit commences commercial operation as defined in paragraph (1) of this definition, the unit's date for commencement of commercial operation shall be the date on which the unit becomes a CAIR NO X unit under § 97.104. (i) For a unit with a date for commencement of commercial operation as defined in paragraph (2) of this definition and that subsequently undergoes a physical change (other than replacement of the unit by a unit at the same source), such date shall remain the date of commencement of commercial operation of the unit, which shall continue to be treated as the same unit. (ii) For a unit with a date for commencement of commercial operation as defined in paragraph (2) of this definition and that is subsequently replaced by a unit at the same source ( e.g., repowered), such date shall remain the replaced unit's date of commencement of commercial operation, and the replacement unit shall be treated as a separate unit with a separate date for commencement of commercial operation as defined in paragraph (1) or (2) of this definition as appropriate. Commence operation means: (1) To have begun any mechanical, chemical, or electronic process, including, with regard to a unit, start-up of a unit's combustion chamber, except as provided in § 97.184(h). (2) For a unit that undergoes a physical change (other than replacement of the unit by a unit at the same source) after the date the unit commences operation as defined in paragraph (1) of this definition, such date shall remain the date of commencement of operation of the unit, which shall continue to be treated as the same unit. (3) For a unit that is replaced by a unit at the same source ( e.g., repowered) after the date the unit commences operation as defined in paragraph (1) of this definition, such date shall remain the replaced unit's date of commencement of operation, and the replacement unit shall be treated as a separate unit with a separate date for commencement of operation as defined in paragraph (1), (2), or (3) of this definition as appropriate, except as provided in § 97.184(h). Common stack means a single flue through which emissions from 2 or more units are exhausted. Compliance account means a CAIR NO X Allowance Tracking System account, established by the Administrator for a CAIR NO X source under subpart FF or II of this part, in which any CAIR NO X allowance allocations for the CAIR NO X units at the source are initially recorded and in which are held any CAIR NO X allowances available for use for a control period in order to meet the source's CAIR NO X emissions limitation in accordance with § 97.154. Continuous emission monitoring system or CEMS means the equipment required under subpart HH of this part to sample, analyze, measure, and provide, by means of readings recorded at least once every 15 minutes (using an automated data acquisition and handling system (DAHS)), a permanent record of nitrogen oxides emissions, stack gas volumetric flow rate, stack gas moisture content, and oxygen or carbon dioxide concentration (as applicable), in a manner consistent with part 75 of this chapter. The following systems are the principal types of continuous emission monitoring systems required under subpart HH of this part: (1) A flow monitoring system, consisting of a stack flow rate monitor and an automated data acquisition and handling system and providing a permanent, continuous record of stack gas volumetric flow rate, in standard cubic feet per hour (scfh); (2) A nitrogen oxides concentration monitoring system, consisting of a NO X pollutant concentration monitor and an automated data acquisition and handling system and providing a permanent, continuous record of NO X emissions, in parts per million (ppm); (3) A nitrogen oxides emission rate (or NO X -diluent) monitoring system, consisting of a NO X pollutant concentration monitor, a diluent gas (CO 2 or O 2 ) monitor, and an automated data acquisition and handling system and providing a permanent, continuous record of NO X concentration, in parts per million (ppm), diluent gas concentration, in percent CO 2 or O 2 , and NO X emission rate, in pounds per million British thermal units (lb/mmBtu); (4) A moisture monitoring system, as defined in § 75.11(b)(2) of this chapter and providing a permanent, continuous record of the stack gas moisture content, in percent H 2 O; (5) A carbon dioxide monitoring system, consisting of a CO 2 pollutant concentration monitor (or an oxygen monitor plus suitable mathematical equations from which the CO 2 concentration is derived) and an automated data acquisition and handling system and providing a permanent, continuous record of CO 2 emissions, in percent CO 2 ; and (6) An oxygen monitoring system, consisting of an O 2 concentration monitor and an automated data acquisition and handling system and providing a permanent, continuous record of O 2 , in percent O 2 . Control period means the period beginning January 1 of a calendar year, except as provided in § 97.106(c)(2), and ending on December 31 of the same year, inclusive. Emissions means air pollutants exhausted from a unit or source into the atmosphere, as measured, recorded, and reported to the Administrator by the CAIR designated representative and as determined by the Administrator in accordance with subpart HH of this part. Excess emissions means any ton of nitrogen oxides emitted by the CAIR NO X units at a CAIR NO X source during a control period that exceeds the CAIR NO X emissions limitation for the source. Fossil fuel means natural gas, petroleum, coal, or any form of solid, liquid, or gaseous fuel derived from such material. Fossil-fuel-fired means, with regard to a unit, combusting any amount of fossil fuel in any calendar year. Fuel oil means any petroleum-based fuel (including diesel fuel or petroleum derivatives such as oil tar) and any recycled or blended petroleum products or petroleum by-products used as a fuel whether in a liquid, solid, or gaseous state. General account means a CAIR NO X Allowance Tracking System account, established under subpart FF of this part, that is not a compliance account. Generator means a device that produces electricity. Gross electrical output means, with regard to a cogeneration unit, electricity made available for use, including any such electricity used in the power production process (which process includes, but is not limited to, any on-site processing or treatment of fuel combusted at the unit and any on-site emission controls). Heat input means, with regard to a specified period of time, the product (in mmBtu/time) of the gross calorific value of the fuel (in Btu/lb) divided by 1,000,000 Btu/mmBtu and multiplied by the fuel feed rate into a combustion device (in lb of fuel/time), as measured, recorded, and reported to the Administrator by the CAIR designated representative and determined by the Administrator in accordance with subpart HH of this part and excluding the heat derived from preheated combustion air, recirculated flue gases, or exhaust from other sources. Heat input rate means the amount of heat input (in mmBtu) divided by unit operating time (in hr) or, with regard to a specific fuel, the amount of heat input attributed to the fuel (in mmBtu) divided by the unit operating time (in hr) during which the unit combusts the fuel. Hg Budget Trading Program means a multi-state Hg air pollution control and emission reduction program approved and administered by the Administrator in accordance subpart HHHH of part 60 of this chapter and § 60.24(h)(6), or established by the Administrator under section 111 of the Clean Air Act, as a means of reducing national Hg emissions. Life-of-the-unit, firm power contractual arrangement means a unit participation power sales agreement under which a utility or industrial customer reserves, or is entitled to receive, a specified amount or percentage of nameplate capacity and associated energy generated by any specified unit and pays its proportional amount of such unit's total costs, pursuant to a contract: (1) For the life of the unit; (2) For a cumulative term of no less than 30 years, including contracts that permit an election for early termination; or (3) For a period no less than 25 years or 70 percent of the economic useful life of the unit determined as of the time the unit is built, with option rights to purchase or release some portion of the nameplate capacity and associated energy generated by the unit at the end of the period. Maximum design heat input means the maximum amount of fuel per hour (in Btu/hr) that a unit is capable of combusting on a steady state basis as of the initial installation of the unit as specified by the manufacturer of the unit. Monitoring system means any monitoring system that meets the requirements of subpart HH of this part, including a continuous emissions monitoring system, an alternative monitoring system, or an excepted monitoring system under part 75 of this chapter. Most stringent State or Federal NO X emissions limitation means, with regard to a unit, the lowest NO X emissions limitation (in terms of lb/mmBtu) that is applicable to the unit under State or Federal law, regardless of the averaging period to which the emissions limitation applies. Nameplate capacity means, starting from the initial installation of a generator, the maximum electrical generating output (in MWe) that the generator is capable of producing on a steady state basis and during continuous operation (when not restricted by seasonal or other deratings) as of such installation as specified by the manufacturer of the generator or, starting from the completion of any subsequent physical change in the generator resulting in an increase in the maximum electrical generating output (in MWe) that the generator is capable of producing on a steady state basis and during continuous operation (when not restricted by seasonal or other deratings), such increased maximum amount as of such completion as specified by the person conducting the physical change. Oil-fired means, for purposes of subpart EE of this part, combusting fuel oil for more than 15.0 percent of the annual heat input in a specified year and not qualifying as coal-fired. Operator means any person who operates, controls, or supervises a CAIR NO X unit or a CAIR NO X source and shall include, but not be limited to, any holding company, utility system, or plant manager of such a unit or source. Owner means any of the following persons: (1) With regard to a CAIR NO X source or a CAIR NO X unit at a source, respectively: (i) Any holder of any portion of the legal or equitable title in a CAIR NO X unit at the source or the CAIR NO X unit; (ii) Any holder of a leasehold interest in a CAIR NO X unit at the source or the CAIR NO X unit; or (iii) Any purchaser of power from a CAIR NO X unit at the source or the CAIR NO X unit under a life-of-the-unit, firm power contractual arrangement; provided that, unless expressly provided for in a leasehold agreement, owner shall not include a passive lessor, or a person who has an equitable interest through such lessor, whose rental payments are not based (either directly or indirectly) on the revenues or income from such CAIR NO X unit; or (2) With regard to any general account, any person who has an ownership interest with respect to the CAIR NO X allowances held in the general account and who is subject to the binding agreement for the CAIR authorized account representative to represent the person's ownership interest with respect to CAIR NO X allowances. Permitting authority means the State air pollution control agency, local agency, other State agency, or other agency authorized by the Administrator to issue or revise permits to meet the requirements of the CAIR NO X Annual Trading Program or, if no such agency has been so authorized, the Administrator. Potential electrical output capacity means 33 percent of a unit's maximum design heat input, divided by 3,413 Btu/kWh, divided by 1,000 kWh/MWh, and multiplied by 8,760 hr/yr. Receive or receipt of means, when referring to the permitting authority or the Administrator, to come into possession of a document, information, or correspondence (whether sent in hard copy or by authorized electronic transmission), as indicated in an official log, or by a notation made on the document, information, or correspondence, by the permitting authority or the Administrator in the regular course of business. Recordation, record, or recorded means, with regard to CAIR NO X allowances, the movement of CAIR NO X allowances by the Administrator into or between CAIR NO X Allowance Tracking System accounts, for purposes of allocation, transfer, or deduction. Reference method means any direct test method of sampling and analyzing for an air pollutant as specified in § 75.22 of this chapter. Replacement, replace, or replaced means, with regard to a unit, the demolishing of a unit, or the permanent shutdown and permanent disabling of a unit, and the construction of another unit (the replacement unit) to be used instead of the demolished or shutdown unit (the replaced unit). Repowered means, with regard to a unit, replacement of a coal-fired boiler with one of the following coal-fired technologies at the same source as the coal-fired boiler: (1) Atmospheric or pressurized fluidized bed combustion; (2) Integrated gasification combined cycle; (3) Magnetohydrodynamics; (4) Direct and indirect coal-fired turbines; (5) Integrated gasification fuel cells; or (6) As determined by the Administrator in consultation with the Secretary of Energy, a derivative of one or more of the technologies under paragraphs (1) through (5) of this definition and any other coal-fired technology capable of controlling multiple combustion emissions simultaneously with improved boiler or generation efficiency and with significantly greater waste reduction relative to the performance of technology in widespread commercial use as of January 1, 2005. Sequential use of energy means: (1) For a topping-cycle cogeneration unit, the use of reject heat from electricity production in a useful thermal energy application or process; or (2) For a bottoming-cycle cogeneration unit, the use of reject heat from useful thermal energy application or process in electricity production. Serial number means, for a CAIR NO X allowance, the unique identification number assigned to each CAIR NO X allowance by the Administrator. Solid waste incineration unit means a stationary, fossil-fuel-fired boiler or stationary, fossil-fuel-fired combustion turbine that is a “solid waste incineration unit” as defined in section 129(g)(1) of the Clean Air Act. Source means all buildings, structures, or installations located in one or more contiguous or adjacent properties under common control of the same person or persons. For purposes of section 502(c) of the Clean Air Act, a “source,” including a “source” with multiple units, shall be considered a single “facility.” State means one of the States or the District of Columbia that is subject to the CAIR NO X Annual Trading Program pursuant to § 52.35 of this chapter. Submit or serve means to send or transmit a document, information, or correspondence to the person specified in accordance with the applicable regulation: (1) In person; (2) By United States Postal Service; or (3) By other means of dispatch or transmission and delivery. Compliance with any “submission” or “service” deadline shall be determined by the date of dispatch, transmission, or mailing and not the date of receipt. Title V operating permit means a permit issued under title V of the Clean Air Act and part 70 or part 71 of this chapter. Title V operating permit regulations means the regulations that the Administrator has approved or issued as meeting the requirements of title V of the Clean Air Act and part 70 or 71 of this chapter. Ton means 2,000 pounds. For the purpose of determining compliance with the CAIR NO X emissions limitation, total tons of nitrogen oxides emissions for a control period shall be calculated as the sum of all recorded hourly emissions (or the mass equivalent of the recorded hourly emission rates) in accordance with subpart HH of this part, but with any remaining fraction of a ton equal to or greater than 0.50 tons deemed to equal one ton and any remaining fraction of a ton less than 0.50 tons deemed to equal zero tons. Topping-cycle cogeneration unit means a cogeneration unit in which the energy input to the unit is first used to produce useful power, including electricity, and at least some of the reject heat from the electricity production is then used to provide useful thermal energy. Total energy input means, with regard to a cogeneration unit, total energy of all forms supplied to the cogeneration unit, excluding energy produced by the cogeneration unit itself. Each form of energy supplied shall be measured by the lower heating value of that form of energy calculated as follows: LHV = HHV − 10.55(W + 9H) Where: LHV = lower heating value of fuel in Btu/lb, HHV = higher heating value of fuel in Btu/lb, W = Weight % of moisture in fuel, and H = Weight % of hydrogen in fuel. Where: LHV = lower heating value of fuel in Btu/lb, HHV = higher heating value of fuel in Btu/lb, W = Weight % of moisture in fuel, and H = Weight % of hydrogen in fuel. Total energy output means, with regard to a cogeneration unit, the sum of useful power and useful thermal energy produced by the cogeneration unit. Unit means a stationary, fossil-fuel-fired boiler or combustion turbine or other stationary, fossil-fuel-fired combustion device. Unit operating day means a calendar day in which a unit combusts any fuel. Unit operating hour or hour of unit operation means an hour in which a unit combusts any fuel. Useful power means, with regard to a cogeneration unit, electricity or mechanical energy made available for use, excluding any such energy used in the power production process (which process includes, but is not limited to, any on-site processing or treatment of fuel combusted at the unit and any on-site emission controls). Useful thermal energy means, with regard to a cogeneration unit, thermal energy that is: (1) Made available to an industrial or commercial process (not a power production process), excluding any heat contained in condensate return or makeup water; (2) Used in a heating application ( e.g., space heating or domestic hot water heating); or (3) Used in a space cooling application ( i.e., thermal energy used by an absorption chiller). Utility power distribution system means the portion of an electricity grid owned or operated by a utility and dedicated to delivering electricity to customers." 40:40:23.0.1.1.1.11.1.3,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,"§ 97.103 Measurements, abbreviations, and acronyms.",EPA,,,,"Measurements, abbreviations, and acronyms used in this subpart and subparts BB through II are defined as follows: Btu—British thermal unit CO 2 —carbon dioxide H 2 O—water Hg—mercury hr—hour kW—kilowatt electrical kWh—kilowatt hour lb—pound mmBtu—million Btu MWe—megawatt electrical MWh—megawatt hour NO X —nitrogen oxides O 2 —oxygen ppm—parts per million scfh—standard cubic feet per hour SO 2 —sulfur dioxide yr—year" 40:40:23.0.1.1.1.11.1.4,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.104 Applicability.,EPA,,,,"(a) Except as provided in paragraph (b) of this section: (1) The following units in a State shall be CAIR NO X units, and any source that includes one or more such units shall be a CAIR NO X source, subject to the requirements of this subpart and subparts BB through HH of this part: any stationary, fossil-fuel-fired boiler or stationary, fossil-fuel-fired combustion turbine serving at any time, since the later of November 15, 1990 or the start-up of the unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe producing electricity for sale. (2) If a stationary boiler or stationary combustion turbine that, under paragraph (a)(1) of this section, is not a CAIR NO X unit begins to combust fossil fuel or to serve a generator with nameplate capacity of more than 25 MWe producing electricity for sale, the unit shall become a CAIR NO X unit as provided in paragraph (a)(1) of this section on the first date on which it both combusts fossil fuel and serves such generator. (b) The units in a State that meet the requirements set forth in paragraph (b)(1)(i), (b)(2)(i), or (b)(2)(ii) of this section shall not be CAIR NO X units: (1)(i) Any unit that is a CAIR NO X unit under paragraph (a)(1) or (2) of this section: (A) Qualifying as a cogeneration unit during the 12-month period starting on the date the unit first produces electricity and continuing to qualify as a cogeneration unit; and (B) Not serving at any time, since the later of November 15, 1990 or the start-up of the unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe supplying in any calendar year more than one-third of the unit's potential electric output capacity or 219,000 MWh, whichever is greater, to any utility power distribution system for sale. (ii) If a unit qualifies as a cogeneration unit during the 12-month period starting on the date the unit first produces electricity and meets the requirements of paragraphs (b)(1)(i) of this section for at least one calendar year, but subsequently no longer meets all such requirements, the unit shall become a CAIR NO X unit starting on the earlier of January 1 after the first calendar year during which the unit first no longer qualifies as a cogeneration unit or January 1 after the first calendar year during which the unit no longer meets the requirements of paragraph (b)(1)(i)(B) of this section. (2)(i) Any unit that is a CAIR NO X unit under paragraph (a)(1) or (2) of this section commencing operation before January 1, 1985: (A) Qualifying as a solid waste incineration unit; and (B) With an average annual fuel consumption of non-fossil fuel for 1985-1987 exceeding 80 percent (on a Btu basis) and an average annual fuel consumption of non-fossil fuel for any 3 consecutive calendar years after 1990 exceeding 80 percent (on a Btu basis). (ii) Any unit that is a CAIR NO X unit under paragraph (a)(1) or (2) of this section commencing operation on or after January 1, 1985: (A) Qualifying as a solid waste incineration unit; and (B) With an average annual fuel consumption of non-fossil fuel for the first 3 calendar years of operation exceeding 80 percent (on a Btu basis) and an average annual fuel consumption of non-fossil fuel for any 3 consecutive calendar years after 1990 exceeding 80 percent (on a Btu basis). (iii) If a unit qualifies as a solid waste incineration unit and meets the requirements of paragraph (b)(2)(i) or (ii) of this section for at least 3 consecutive calendar years, but subsequently no longer meets all such requirements, the unit shall become a CAIR NO X unit starting on the earlier of January 1 after the first calendar year during which the unit first no longer qualifies as a solid waste incineration unit or January 1 after the first 3 consecutive calendar years after 1990 for which the unit has an average annual fuel consumption of fossil fuel of 20 percent or more. (c) A certifying official of an owner or operator of any unit may petition the Administrator at any time for a determination concerning the applicability, under paragraphs (a) and (b) of this section, of the CAIR NO X Annual Trading Program to the unit. (1) Petition content. The petition shall be in writing and include the identification of the unit and the relevant facts about the unit. The petition and any other documents provided to the Administrator in connection with the petition shall include the following certification statement, signed by the certifying official: “I am authorized to make this submission on behalf of the owners and operators of the unit for which the submission is made. I certify under penalty of law that I have personally examined, and am familiar with, the statements and information submitted in this document and all its attachments. Based on my inquiry of those individuals with primary responsibility for obtaining the information, I certify that the statements and information are to the best of my knowledge and belief true, accurate, and complete. I am aware that there are significant penalties for submitting false statements and information or omitting required statements and information, including the possibility of fine or imprisonment.” (2) Submission. The petition and any other documents provided in connection with the petition shall be submitted to the Director of the Clean Air Markets Division (or its successor), U.S. Environmental Protection Agency, who will act on the petition as the Administrator's duly authorized representative. (3) Response. The Administrator will issue a written response to the petition and may request supplemental information relevant to such petition. The Administrator's determination concerning the applicability, under paragraphs (a) and (b) of this section, of the CAIR NO X Annual Trading Program to the unit shall be binding on the permitting authority unless the petition or other information or documents provided in connection with the petition are found to have contained significant, relevant errors or omissions." 40:40:23.0.1.1.1.11.1.5,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.105 Retired unit exemption.,EPA,,,,"(a)(1) Any CAIR NO X unit that is permanently retired and is not a CAIR NO X opt-in unit under subpart II of this part shall be exempt from the CAIR NO X Annual Trading Program, except for the provisions of this section, §§ 97.102, 97.103, 97.104, 97.106(c)(4) through (7), 97.107, 97.108, and subparts BB and EE through GG of this part. (2) The exemption under paragraph (a)(1) of this section shall become effective the day on which the CAIR NO X unit is permanently retired. Within 30 days of the unit's permanent retirement, the CAIR designated representative shall submit a statement to the permitting authority otherwise responsible for administering any CAIR permit for the unit and shall submit a copy of the statement to the Administrator. The statement shall state, in a format prescribed by the permitting authority, that the unit was permanently retired on a specific date and will comply with the requirements of paragraph (b) of this section. (3) After receipt of the statement under paragraph (a)(2) of this section, the permitting authority will amend any permit under subpart CC of this part covering the source at which the unit is located to add the provisions and requirements of the exemption under paragraphs (a)(1) and (b) of this section. (b) Special provisions. (1) A unit exempt under paragraph (a) of this section shall not emit any nitrogen oxides, starting on the date that the exemption takes effect. (2) The Administrator or the permitting authority will allocate CAIR NO X allowances under subpart EE of this part to a unit exempt under paragraph (a) of this section. (3) For a period of 5 years from the date the records are created, the owners and operators of a unit exempt under paragraph (a) of this section shall retain, at the source that includes the unit, records demonstrating that the unit is permanently retired. The 5-year period for keeping records may be extended for cause, at any time before the end of the period, in writing by the permitting authority or the Administrator. The owners and operators bear the burden of proof that the unit is permanently retired. (4) The owners and operators and, to the extent applicable, the CAIR designated representative of a unit exempt under paragraph (a) of this section shall comply with the requirements of the CAIR NO X Annual Trading Program concerning all periods for which the exemption is not in effect, even if such requirements arise, or must be complied with, after the exemption takes effect. (5) A unit exempt under paragraph (a) of this section and located at a source that is required, or but for this exemption would be required, to have a title V operating permit shall not resume operation unless the CAIR designated representative of the source submits a complete CAIR permit application under § 97.122 for the unit not less than 18 months (or such lesser time provided by the permitting authority) before the later of January 1, 2009 or the date on which the unit resumes operation. (6) On the earlier of the following dates, a unit exempt under paragraph (a) of this section shall lose its exemption: (i) The date on which the CAIR designated representative submits a CAIR permit application for the unit under paragraph (b)(5) of this section; (ii) The date on which the CAIR designated representative is required under paragraph (b)(5) of this section to submit a CAIR permit application for the unit; or (iii) The date on which the unit resumes operation, if the CAIR designated representative is not required to submit a CAIR permit application for the unit. (7) For the purpose of applying monitoring, reporting, and recordkeeping requirements under subpart HH of this part, a unit that loses its exemption under paragraph (a) of this section shall be treated as a unit that commences commercial operation on the first date on which the unit resumes operation." 40:40:23.0.1.1.1.11.1.6,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.106 Standard requirements.,EPA,,,,"(a) Permit requirements. (1) The CAIR designated representative of each CAIR NO X source required to have a title V operating permit and each CAIR NO X unit required to have a title V operating permit at the source shall: (i) Submit to the permitting authority a complete CAIR permit application under § 97.122 in accordance with the deadlines specified in § 97.121; and (ii) Submit in a timely manner any supplemental information that the permitting authority determines is necessary in order to review a CAIR permit application and issue or deny a CAIR permit. (2) The owners and operators of each CAIR NO X source required to have a title V operating permit and each CAIR NO X unit required to have a title V operating permit at the source shall have a CAIR permit issued by the permitting authority under subpart CC of this part for the source and operate the source and the unit in compliance with such CAIR permit. (3) Except as provided in subpart II of this part, the owners and operators of a CAIR NO X source that is not otherwise required to have a title V operating permit and each CAIR NO X unit that is not otherwise required to have a title V operating permit are not required to submit a CAIR permit application, and to have a CAIR permit, under subpart CC of this part for such CAIR NO X source and such CAIR NO X unit. (b) Monitoring, reporting, and recordkeeping requirements. (1) The owners and operators, and the CAIR designated representative, of each CAIR NO X source and each CAIR NO X unit at the source shall comply with the monitoring, reporting, and recordkeeping requirements of subpart HH of this part. (2) The emissions measurements recorded and reported in accordance with subpart HH of this part shall be used to determine compliance by each CAIR NO X source with the CAIR NO X emissions limitation under paragraph (c) of this section. (c) Nitrogen oxides emission requirements. (1) As of the allowance transfer deadline for a control period, the owners and operators of each CAIR NO X source and each CAIR NO X unit at the source shall hold, in the source's compliance account, CAIR NO X allowances available for compliance deductions for the control period under § 97.154(a) in an amount not less than the tons of total nitrogen oxides emissions for the control period from all CAIR NO X units at the source, as determined in accordance with subpart HH of this part. (2) A CAIR NO X unit shall be subject to the requirements under paragraph (c)(1) of this section for the control period starting on the later of January 1, 2009 or the deadline for meeting the unit's monitor certification requirements under § 97.170(b)(1), (2), or (5) and for each control period thereafter. (3) A CAIR NO X allowance shall not be deducted, for compliance with the requirements under paragraph (c)(1) of this section, for a control period in a calendar year before the year for which the CAIR NO X allowance was allocated. (4) CAIR NO X allowances shall be held in, deducted from, or transferred into or among CAIR NO X Allowance Tracking System accounts in accordance with subparts EE, FF, GG, and II of this part. (5) A CAIR NO X allowance is a limited authorization to emit one ton of nitrogen oxides in accordance with the CAIR NO X Annual Trading Program. No provision of the CAIR NO X Annual Trading Program, the CAIR permit application, the CAIR permit, or an exemption under § 97.105 and no provision of law shall be construed to limit the authority of the United States to terminate or limit such authorization. (6) A CAIR NO X allowance does not constitute a property right. (7) Upon recordation by the Administrator under subpart EE, FF, GG, or II of this part, every allocation, transfer, or deduction of a CAIR NO X allowance to or from a CAIR NO X source's compliance account is incorporated automatically in any CAIR permit of the source. (d) Excess emissions requirements. If a CAIR NO X source emits nitrogen oxides during any control period in excess of the CAIR NO X emissions limitation, then: (1) The owners and operators of the source and each CAIR NO X unit at the source shall surrender the CAIR NO X allowances required for deduction under § 97.154(d)(1) and pay any fine, penalty, or assessment or comply with any other remedy imposed, for the same violations, under the Clean Air Act or applicable State law; and (2) Each ton of such excess emissions and each day of such control period shall constitute a separate violation of this subpart, the Clean Air Act, and applicable State law. (e) Recordkeeping and reporting requirements. (1) Unless otherwise provided, the owners and operators of the CAIR NO X source and each CAIR NO X unit at the source shall keep on site at the source each of the following documents for a period of 5 years from the date the document is created. This period may be extended for cause, at any time before the end of 5 years, in writing by the permitting authority or the Administrator. (i) The certificate of representation under § 97.113 for the CAIR designated representative for the source and each CAIR NO X unit at the source and all documents that demonstrate the truth of the statements in the certificate of representation; provided that the certificate and documents shall be retained on site at the source beyond such 5-year period until such documents are superseded because of the submission of a new certificate of representation under § 97.113 changing the CAIR designated representative. (ii) All emissions monitoring information, in accordance with subpart HH of this part, provided that to the extent that subpart HH of this part provides for a 3-year period for recordkeeping, the 3-year period shall apply. (iii) Copies of all reports, compliance certifications, and other submissions and all records made or required under the CAIR NO X Annual Trading Program. (iv) Copies of all documents used to complete a CAIR permit application and any other submission under the CAIR NO X Annual Trading Program or to demonstrate compliance with the requirements of the CAIR NO X Annual Trading Program. (2) The CAIR designated representative of a CAIR NO X source and each CAIR NO X unit at the source shall submit the reports required under the CAIR NO X Annual Trading Program, including those under subpart HH of this part. (f) Liability. (1) Each CAIR NO X source and each CAIR NO X unit shall meet the requirements of the CAIR NO X Annual Trading Program. (2) Any provision of the CAIR NO X Annual Trading Program that applies to a CAIR NO X source or the CAIR designated representative of a CAIR NO X source shall also apply to the owners and operators of such source and of the CAIR NO X units at the source. (3) Any provision of the CAIR NO X Annual Trading Program that applies to a CAIR NO X unit or the CAIR designated representative of a CAIR NO X unit shall also apply to the owners and operators of such unit. (g) Effect on other authorities. No provision of the CAIR NO X Annual Trading Program, a CAIR permit application, a CAIR permit, or an exemption under § 97.105 shall be construed as exempting or excluding the owners and operators, and the CAIR designated representative, of a CAIR NO X source or CAIR NO X unit from compliance with any other provision of the applicable, approved State implementation plan, a federally enforceable permit, or the Clean Air Act." 40:40:23.0.1.1.1.11.1.7,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.107 Computation of time.,EPA,,,,"(a) Unless otherwise stated, any time period scheduled, under the CAIR NO X Annual Trading Program, to begin on the occurrence of an act or event shall begin on the day the act or event occurs. (b) Unless otherwise stated, any time period scheduled, under the CAIR NO X Annual Trading Program, to begin before the occurrence of an act or event shall be computed so that the period ends the day before the act or event occurs. (c) Unless otherwise stated, if the final day of any time period, under the CAIR NO X Annual Trading Program, falls on a weekend or a State or Federal holiday, the time period shall be extended to the next business day." 40:40:23.0.1.1.1.11.1.8,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",AA,Subpart AA—CAIR NO,,§ 97.108 Appeal procedures.,EPA,,,,The appeal procedures for decisions of the Administrator under the CAIR NO X Annual Trading Program are set forth in part 78 of this chapter. 40:40:23.0.1.1.1.12.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",BB,Subpart BB—CAIR Designated Representative for CAIR NO,,§ 97.110 Authorization and responsibilities of CAIR designated representative.,EPA,,,,"(a) Except as provided under § 97.111, each CAIR NO X source, including all CAIR NO X units at the source, shall have one and only one CAIR designated representative, with regard to all matters under the CAIR NO X Annual Trading Program concerning the source or any CAIR NO X unit at the source. (b) The CAIR designated representative of the CAIR NO X source shall be selected by an agreement binding on the owners and operators of the source and all CAIR NO X units at the source and shall act in accordance with the certification statement in § 97.113(a)(4)(iv). (c) Upon receipt by the Administrator of a complete certificate of representation under § 97.113, the CAIR designated representative of the source shall represent and, by his or her representations, actions, inactions, or submissions, legally bind each owner and operator of the CAIR NO X source represented and each CAIR NO X unit at the source in all matters pertaining to the CAIR NO X Annual Trading Program, notwithstanding any agreement between the CAIR designated representative and such owners and operators. The owners and operators shall be bound by any decision or order issued to the CAIR designated representative by the permitting authority, the Administrator, or a court regarding the source or unit. (d) No CAIR permit will be issued, no emissions data reports will be accepted, and no CAIR NO X Allowance Tracking System account will be established for a CAIR NO X unit at a source, until the Administrator has received a complete certificate of representation under § 97.113 for a CAIR designated representative of the source and the CAIR NO X units at the source. (e)(1) Each submission under the CAIR NO X Annual Trading Program shall be submitted, signed, and certified by the CAIR designated representative for each CAIR NO X source on behalf of which the submission is made. Each such submission shall include the following certification statement by the CAIR designated representative: “I am authorized to make this submission on behalf of the owners and operators of the source or units for which the submission is made. I certify under penalty of law that I have personally examined, and am familiar with, the statements and information submitted in this document and all its attachments. Based on my inquiry of those individuals with primary responsibility for obtaining the information, I certify that the statements and information are to the best of my knowledge and belief true, accurate, and complete. I am aware that there are significant penalties for submitting false statements and information or omitting required statements and information, including the possibility of fine or imprisonment.” (2) The permitting authority and the Administrator will accept or act on a submission made on behalf of owner or operators of a CAIR NO X source or a CAIR NO X unit only if the submission has been made, signed, and certified in accordance with paragraph (e)(1) of this section." 40:40:23.0.1.1.1.12.1.2,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",BB,Subpart BB—CAIR Designated Representative for CAIR NO,,§ 97.111 Alternate CAIR designated representative.,EPA,,,,"(a) A certificate of representation under § 97.113 may designate one and only one alternate CAIR designated representative, who may act on behalf of the CAIR designated representative. The agreement by which the alternate CAIR designated representative is selected shall include a procedure for authorizing the alternate CAIR designated representative to act in lieu of the CAIR designated representative. (b) Upon receipt by the Administrator of a complete certificate of representation under § 97.113, any representation, action, inaction, or submission by the alternate CAIR designated representative shall be deemed to be a representation, action, inaction, or submission by the CAIR designated representative. (c) Except in this section and §§ 97.102, 97.110(a) and (d), 97.112, 97.113, 97.115, 97.151 and 97.182, whenever the term “CAIR designated representative” is used in subparts AA through II of this part, the term shall be construed to include the CAIR designated representative or any alternate CAIR designated representative." 40:40:23.0.1.1.1.12.1.3,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",BB,Subpart BB—CAIR Designated Representative for CAIR NO,,§ 97.112 Changing CAIR designated representative and alternate CAIR designated representative; changes in owners and operators.,EPA,,,,"(a) Changing CAIR designated representative. The CAIR designated representative may be changed at any time upon receipt by the Administrator of a superseding complete certificate of representation under § 97.113. Notwithstanding any such change, all representations, actions, inactions, and submissions by the previous CAIR designated representative before the time and date when the Administrator receives the superseding certificate of representation shall be binding on the new CAIR designated representative and the owners and operators of the CAIR NO X source and the CAIR NO X units at the source. (b) Changing alternate CAIR designated representative. The alternate CAIR designated representative may be changed at any time upon receipt by the Administrator of a superseding complete certificate of representation under § 97.113. Notwithstanding any such change, all representations, actions, inactions, and submissions by the previous alternate CAIR designated representative before the time and date when the Administrator receives the superseding certificate of representation shall be binding on the new alternate CAIR designated representative and the owners and operators of the CAIR NO X source and the CAIR NO X units at the source. (c) Changes in owners and operators. (1) In the event an owner or operator of a CAIR NO X source or a CAIR NO X unit is not included in the list of owners and operators in the certificate of representation under § 97.113, such owner or operator shall be deemed to be subject to and bound by the certificate of representation, the representations, actions, inactions, and submissions of the CAIR designated representative and any alternate CAIR designated representative of the source or unit, and the decisions and orders of the permitting authority, the Administrator, or a court, as if the owner or operator were included in such list. (2) Within 30 days following any change in the owners and operators of a CAIR NO X source or a CAIR NO X unit, including the addition of a new owner or operator, the CAIR designated representative or any alternate CAIR designated representative shall submit a revision to the certificate of representation under § 97.113 amending the list of owners and operators to include the change." 40:40:23.0.1.1.1.12.1.4,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",BB,Subpart BB—CAIR Designated Representative for CAIR NO,,§ 97.113 Certificate of representation.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 71 FR 74795, Dec. 13, 2006]","(a) A complete certificate of representation for a CAIR designated representative or an alternate CAIR designated representative shall include the following elements in a format prescribed by the Administrator: (1) Identification of the CAIR NO X source, and each CAIR NO X unit at the source, for which the certificate of representation is submitted, including identification and nameplate capacity of each generator served by each such unit. (2) The name, address, e-mail address (if any), telephone number, and facsimile transmission number (if any) of the CAIR designated representative and any alternate CAIR designated representative. (3) A list of the owners and operators of the CAIR NO X source and of each CAIR NO X unit at the source. (4) The following certification statements by the CAIR designated representative and any alternate CAIR designated representative— (i) “I certify that I was selected as the CAIR designated representative or alternate CAIR designated representative, as applicable, by an agreement binding on the owners and operators of the source and each CAIR NO X unit at the source.” (ii) “I certify that I have all the necessary authority to carry out my duties and responsibilities under the CAIR NO X Annual Trading Program on behalf of the owners and operators of the source and of each CAIR NO X unit at the source and that each such owner and operator shall be fully bound by my representations, actions, inactions, or submissions.” (iii) “I certify that the owners and operators of the source and of each CAIR NO X unit at the source shall be bound by any order issued to me by the Administrator, the permitting authority, or a court regarding the source or unit.” (iv) Where there are multiple holders of a legal or equitable title to, or a leasehold interest in, a CAIR NO X unit, or where a utility or industrial customer purchases power from a CAIR NO X unit under a life-of-the-unit, firm power contractual arrangement, I certify that: I have given a written notice of my selection as the ‘CAIR designated representative’ or ‘alternate CAIR designated representative’, as applicable, and of the agreement by which I was selected to each owner and operator of the source and of each CAIR NO X unit at the source; and CAIR NO X allowances and proceeds of transactions involving CAIR NO X allowances will be deemed to be held or distributed in proportion to each holder's legal, equitable, leasehold, or contractual reservation or entitlement, except that, if such multiple holders have expressly provided for a different distribution of CAIR NO X allowances by contract, CAIR NO X allowances and proceeds of transactions involving CAIR NO X allowances will be deemed to be held or distributed in accordance with the contract.” (5) The signature of the CAIR designated representative and any alternate CAIR designated representative and the dates signed. (b) Unless otherwise required by the permitting authority or the Administrator, documents of agreement referred to in the certificate of representation shall not be submitted to the permitting authority or the Administrator. Neither the permitting authority nor the Administrator shall be under any obligation to review or evaluate the sufficiency of such documents, if submitted." 40:40:23.0.1.1.1.12.1.5,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",BB,Subpart BB—CAIR Designated Representative for CAIR NO,,§ 97.114 Objections concerning CAIR designated representative.,EPA,,,,"(a) Once a complete certificate of representation under § 97.113 has been submitted and received, the permitting authority and the Administrator will rely on the certificate of representation unless and until a superseding complete certificate of representation under § 97.113 is received by the Administrator. (b) Except as provided in § 97.112(a) or (b), no objection or other communication submitted to the permitting authority or the Administrator concerning the authorization, or any representation, action, inaction, or submission, of the CAIR designated representative shall affect any representation, action, inaction, or submission of the CAIR designated representative or the finality of any decision or order by the permitting authority or the Administrator under the CAIR NO X Annual Trading Program. (c) Neither the permitting authority nor the Administrator will adjudicate any private legal dispute concerning the authorization or any representation, action, inaction, or submission of any CAIR designated representative, including private legal disputes concerning the proceeds of CAIR NO X allowance transfers." 40:40:23.0.1.1.1.12.1.6,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",BB,Subpart BB—CAIR Designated Representative for CAIR NO,,§ 97.115 Delegation by CAIR designated representative and alternate CAIR designated representative.,EPA,,,,"(a) A CAIR designated representative may delegate, to one or more natural persons, his or her authority to make an electronic submission to the Administrator provided for or required under this part. (b) An alternate CAIR designated representative may delegate, to one or more natural persons, his or her authority to make an electronic submission to the Administrator provided for or required under this part. (c) In order to delegate authority to make an electronic submission to the Administrator in accordance with paragraph (a) or (b) of this section, the CAIR designated representative or alternate CAIR designated representative, as appropriate, must submit to the Administrator a notice of delegation, in a format prescribed by the Administrator, that includes the following elements: (1) The name, address, e-mail address, telephone number, and facsimile transmission number (if any) of such CAIR designated representative or alternate CAIR designated representative; (2) The name, address, e-mail address, telephone number, and facsimile transmission number (if any) of each such natural person (referred to as an “agent”); (3) For each such natural person, a list of the type or types of electronic submissions under paragraph (a) or (b) of this section for which authority is delegated to him or her; and (4) The following certification statements by such CAIR designated representative or alternate CAIR designated representative: (i) “I agree that any electronic submission to the Administrator that is by an agent identified in this notice of delegation and of a type listed for such agent in this notice of delegation and that is made when I am a CAIR designated representative or alternate CAIR designated representative, as appropriate, and before this notice of delegation is superseded by another notice of delegation under 40 CFR 97.115(d) shall be deemed to be an electronic submission by me.” (ii) “Until this notice of delegation is superseded by another notice of delegation under 40 CFR 97.115(d), I agree to maintain an e-mail account and to notify the Administrator immediately of any change in my e-mail address unless all delegation of authority by me under 40 CFR 97.115 is terminated.”. (d) A notice of delegation submitted under paragraph (c) of this section shall be effective, with regard to the CAIR designated representative or alternate CAIR designated representative identified in such notice, upon receipt of such notice by the Administrator and until receipt by the Administrator of a superseding notice of delegation submitted by such CAIR designated representative or alternate CAIR designated representative, as appropriate. The superseding notice of delegation may replace any previously identified agent, add a new agent, or eliminate entirely any delegation of authority. (e) Any electronic submission covered by the certification in paragraph (c)(4)(i) of this section and made in accordance with a notice of delegation effective under paragraph (d) of this section shall be deemed to be an electronic submission by the CAIR designated representative or alternate CAIR designated representative submitting such notice of delegation." 40:40:23.0.1.1.1.13.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",CC,Subpart CC—Permits,,§ 97.120 General CAIR NO,EPA,,,,"(a) For each CAIR NO X source required to have a title V operating permit or required, under subpart II of this part, to have a title V operating permit or other federally enforceable permit, such permit shall include a CAIR permit administered by the permitting authority for the title V operating permit or the federally enforceable permit as applicable. The CAIR portion of the title V permit or other federally enforceable permit as applicable shall be administered in accordance with the permitting authority's title V operating permits regulations promulgated under part 70 or 71 of this chapter or the permitting authority's regulations for other federally enforceable permits as applicable, except as provided otherwise by § 97.105, this subpart, and subpart II of this part. (b) Each CAIR permit shall contain, with regard to the CAIR NO X source and the CAIR NO X units at the source covered by the CAIR permit, all applicable CAIR NO X Annual Trading Program, CAIR NO X Ozone Season Trading Program, and CAIR SO 2 Trading Program requirements and shall be a complete and separable portion of the title V operating permit or other federally enforceable permit under paragraph (a) of this section." 40:40:23.0.1.1.1.13.1.2,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",CC,Subpart CC—Permits,,§ 97.121 Submission of CAIR permit applications.,EPA,,,,"(a) Duty to apply. The CAIR designated representative of any CAIR NO X source required to have a title V operating permit shall submit to the permitting authority a complete CAIR permit application under § 97.122 for the source covering each CAIR NO X unit at the source at least 18 months (or such lesser time provided by the permitting authority) before the later of January 1, 2009 or the date on which the CAIR NO X unit commences commercial operation, except as provided in § 97.183(a). (b) Duty to reapply. For a CAIR NO X source required to have a title V operating permit, the CAIR designated representative shall submit a complete CAIR permit application under § 97.122 for the source covering each CAIR NO X unit at the source to renew the CAIR permit in accordance with the permitting authority's title V operating permits regulations addressing permit renewal, except as provided in § 97.183(b)." 40:40:23.0.1.1.1.13.1.3,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",CC,Subpart CC—Permits,,§ 97.122 Information requirements for CAIR permit applications.,EPA,,,,"A complete CAIR permit application shall include the following elements concerning the CAIR NO X source for which the application is submitted, in a format prescribed by the permitting authority: (a) Identification of the CAIR NO X source; (b) Identification of each CAIR NO X unit at the CAIR NO X source; and (c) The standard requirements under § 97.106." 40:40:23.0.1.1.1.13.1.4,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",CC,Subpart CC—Permits,,§ 97.123 CAIR permit contents and term.,EPA,,,,"(a) Each CAIR permit will contain, in a format prescribed by the permitting authority, all elements required for a complete CAIR permit application under § 97.122. (b) Each CAIR permit is deemed to incorporate automatically the definitions of terms under § 97.102 and, upon recordation by the Administrator under subpart EE, FF, GG, or II of this part, every allocation, transfer, or deduction of a CAIR NO X allowance to or from the compliance account of the CAIR NO X source covered by the permit. (c) The term of the CAIR permit will be set by the permitting authority, as necessary to facilitate coordination of the renewal of the CAIR permit with issuance, revision, or renewal of the CAIR NO X source's title V operating permit or other federally enforceable permit as applicable." 40:40:23.0.1.1.1.13.1.5,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",CC,Subpart CC—Permits,,§ 97.124 CAIR permit revisions.,EPA,,,,"Except as provided in § 97.123(b), the permitting authority will revise the CAIR permit, as necessary, in accordance with the permitting authority's title V operating permits regulations or the permitting authority's regulations for other federally enforceable permits as applicable addressing permit revisions." 40:40:23.0.1.1.1.15.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",EE,Subpart EE—CAIR NO,,§ 97.140 State trading budgets.,EPA,,,,The State trading budgets for annual allocations of CAIR NO X allowances for the control periods in 2009 through 2014 and in 2015 and thereafter are respectively as follows: 40:40:23.0.1.1.1.15.1.2,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",EE,Subpart EE—CAIR NO,,§ 97.141 Timing requirements for CAIR NO,EPA,,,,"(a) The Administrator will determine by order the CAIR NO X allowance allocations, in accordance with § 97.142(a) and (b), for the control periods in 2009, 2010, 2011, 2012, 2013, and 2014. (b) By July 31, 2011 and July 31 of each year thereafter, the Administrator will determine by order the CAIR NO X allowance allocations, in accordance with § 97.142(a) and (b), for the control period in the fourth year after the year of the applicable deadline for determination under this paragraph. (c) By July 31, 2009 and July 31 of each year thereafter, the Administrator will determine by order the CAIR NO X allowance allocations, in accordance with § 97.142(a),(c), and (d), for the control period in the year of the applicable deadline for determination under this paragraph. (d) The Administrator will make available to the public each determination of CAIR NO X allowances under paragraph (a), (b), or (c) of this section and will provide an opportunity for submission of objections to the determination. Objections shall be limited to addressing whether the determination is in accordance with § 97.142. Based on any such objections, the Administrator will adjust each determination to the extent necessary to ensure that it is in accordance with § 97.142." 40:40:23.0.1.1.1.15.1.3,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",EE,Subpart EE—CAIR NO,,§ 97.142 CAIR NO,EPA,,,,"(a)(1) The baseline heat input (in mmBtu) used with respect to CAIR NO X allowance allocations under paragraph (b) of this section for each CAIR NO X unit will be: (i) For units commencing operation before January 1, 2001 the average of the 3 highest amounts of the unit's adjusted control period heat input for 2000 through 2004, with the adjusted control period heat input for each year calculated as follows: (A) If the unit is coal-fired during the year, the unit's control period heat input for such year is multiplied by 100 percent; (B) If the unit is oil-fired during the year, the unit's control period heat input for such year is multiplied by 60 percent; and (C) If the unit is not subject to paragraph (a)(1)(i)(A) or (B) of this section, the unit's control period heat input for such year is multiplied by 40 percent. (ii) For units commencing operation on or after January 1, 2001 and operating each calendar year during a period of 5 or more consecutive calendar years, the average of the 3 highest amounts of the unit's total converted control period heat input over the first such 5 years. (2)(i) A unit's control period heat input, and a unit's status as coal-fired or oil-fired, for a calendar year under paragraph (a)(1)(i) of this section, and a unit's total tons of NO X emissions during a calendar year under paragraph (c)(3) of this section, will be determined in accordance with part 75 of this chapter, to the extent the unit was otherwise subject to the requirements of part 75 of this chapter for the year, or will be based on the best available data reported to the Administrator for the unit (in a format prescribed by the Administrator), to the extent the unit was not otherwise subject to the requirements of part 75 of this chapter for the year. (ii) A unit's converted control period heat input for a calendar year specified under paragraph (a)(1)(ii) of this section equals: (A) Except as provided in paragraph (a)(2)(ii)(B) or (C) of this section, the control period gross electrical output of the generator or generators served by the unit multiplied by 7,900 Btu/kWh, if the unit is coal-fired for the year, or 6,675 Btu/kWh, if the unit is not coal-fired for the year, and divided by 1,000,000 Btu/mmBtu, provided that if a generator is served by 2 or more units, then the gross electrical output of the generator will be attributed to each unit in proportion to the unit's share of the total control period heat input of such units for the year; (B) For a unit that is a boiler and has equipment used to produce electricity and useful thermal energy for industrial, commercial, heating, or cooling purposes through the sequential use of energy, the total heat energy (in Btu) of the steam produced by the boiler during the control period, divided by 0.8 and by 1,000,000 Btu/mmBtu; or (C) For a unit that is a combustion turbine and has equipment used to produce electricity and useful thermal energy for industrial, commercial, heating, or cooling purposes through the sequential use of energy, the control period gross electrical output of the enclosed device comprising the compressor, combustor, and turbine multiplied by 3,413 Btu/kWh, plus the total heat energy (in Btu) of the steam produced by any associated heat recovery steam generator during the control period divided by 0.8, and with the sum divided by 1,000,000 Btu/mmBtu. (iii) Gross electrical output and total heat energy under paragraph (a)(2)(ii) of this section will be determined based on the best available data reported to the Administrator for the unit (in a format prescribed by the Administrator). (3) The Administrator will determine what data are the best available data under paragraph (a)(2) of this section by weighing the likelihood that data are accurate and reliable and giving greater weight to data submitted to a governmental entity in compliance with legal requirements or substantiated by an independent entity. (b)(1) For each control period in 2009 and thereafter, the Administrator will allocate to all CAIR NO X units in a State that have a baseline heat input (as determined under paragraph (a) of this section) a total amount of CAIR NO X allowances equal to 95 percent for a control period during 2009 through 2014, and 97 percent for a control period during 2015 and thereafter, of the tons of NO X emissions in the applicable State trading budget under § 97.140 (except as provided in paragraphs (d) and (e) of this section). (2) The Administrator will allocate CAIR NO X allowances to each CAIR NO X unit under paragraph (b)(1) of this section in an amount determined by multiplying the total amount of CAIR NO X allowances allocated under paragraph (b)(1) of this section by the ratio of the baseline heat input of such CAIR NO X unit to the total amount of baseline heat input of all such CAIR NO X units in the State and rounding to the nearest whole allowance as appropriate. (c) For each control period in 2009 and thereafter, the Administrator will allocate CAIR NO X allowances to CAIR NO X units in a State that are not allocated CAIR NO X allowances under paragraph (b) of this section because the units do not yet have a baseline heat input under paragraph (a) of this section or because the units have a baseline heat input but all CAIR NO X allowances available under paragraph (b) of this section for the control period are already allocated, in accordance with the following procedures: (1) The Administrator will establish a separate new unit set-aside for each control period. Each new unit set-aside will be allocated CAIR NO X allowances equal to 5 percent for a control period in 2009 through 2014, and 3 percent for a control period in 2015 and thereafter, of the amount of tons of NO X emissions in the applicable State trading budget under § 97.140. (2) The CAIR designated representative of such a CAIR NO X unit may submit to the Administrator a request, in a format specified by the Administrator, to be allocated CAIR NO X allowances, starting with the later of the control period in 2009 or the first control period after the control period in which the CAIR NO X unit commences commercial operation and until the first control period for which the unit is allocated CAIR NO X allowances under paragraph (b) of this section. A separate CAIR NO X allowance allocation request for each control period for which CAIR NO X allowances are sought must be submitted on or before May 1 of such control period and after the date on which the CAIR NO X unit commences commercial operation. (3) In a CAIR NO X allowance allocation request under paragraph (c)(2) of this section, the CAIR designated representative may request for a control period CAIR NO X allowances in an amount not exceeding the CAIR NO X unit's total tons of NO X emissions during the calendar year immediately before such control period. (4) The Administrator will review each CAIR NO X allowance allocation request under paragraph (c)(2) of this section and will allocate CAIR NO X allowances for each control period pursuant to such request as follows: (i) The Administrator will accept an allowance allocation request only if the request meets, or is adjusted by the Administrator as necessary to meet, the requirements of paragraphs (c)(2) and (3) of this section. (ii) On or after May 1 of the control period, the Administrator will determine the sum of the CAIR NO X allowances requested (as adjusted under paragraph (c)(4)(i) of this section) in all allowance allocation requests accepted under paragraph (c)(4)(i) of this section for the control period. (iii) If the amount of CAIR NO X allowances in the new unit set-aside for the control period is greater than or equal to the sum under paragraph (c)(4)(ii) of this section, then the Administrator will allocate the amount of CAIR NO X allowances requested (as adjusted under paragraph (c)(4)(i) of this section) to each CAIR NO X unit covered by an allowance allocation request accepted under paragraph (c)(4)(i) of this section. (iv) If the amount of CAIR NO X allowances in the new unit set-aside for the control period is less than the sum under paragraph (c)(4)(ii) of this section, then the Administrator will allocate to each CAIR NO X unit covered by an allowance allocation request accepted under paragraph (c)(4)(i) of this section the amount of the CAIR NO X allowances requested (as adjusted under paragraph (c)(4)(i) of this section), multiplied by the amount of CAIR NO X allowances in the new unit set-aside for the control period, divided by the sum determined under paragraph (c)(4)(ii) of this section, and rounded to the nearest whole allowance as appropriate. (v) The Administrator will notify each CAIR designated representative that submitted an allowance allocation request of the amount of CAIR NO X allowances (if any) allocated for the control period to the CAIR NO X unit covered by the request. (d) If, after completion of the procedures under paragraph (c)(4) of this section for a control period, any unallocated CAIR NO X allowances remain in the new unit set-aside under paragraph (c) of this section for a State for the control period, the Administrator will allocate to each CAIR NO X unit that was allocated CAIR NO X allowances under paragraph (b) of this section in the State an amount of CAIR NO X allowances equal to the total amount of such remaining unallocated CAIR NO X allowances, multiplied by the unit's allocation under paragraph (b) of this section, divided by 95 percent for a control period during 2009 through 2014, and 97 percent for a control period during 2015 and thereafter, of the amount of tons of NO X emissions in the applicable State trading budget under § 97.140, and rounded to the nearest whole allowance as appropriate. (e) If the Administrator determines that CAIR NO X allowances were allocated under paragraphs (a) and (b) of this section, paragraphs (a) and (c) of this section, or paragraph (d) of this section for a control period and that the recipient of the allocation is not actually a CAIR NO X unit under § 97.104 in such control period, then the Administrator will notify the CAIR designated representative and will act in accordance with the following procedures: (1) Except as provided in paragraph (e)(2) or (3) of this section, the Administrator will not record such CAIR NO X allowances under § 97.153. (2) If the Administrator already recorded such CAIR NO X allowances under § 97.153 and if the Administrator makes such determination before making deductions for the source that includes such recipient under § 97.154(b) for the control period, then the Administrator will deduct from the account in which such CAIR NO X allowances were recorded under § 97.153 an amount of CAIR NO X allowances allocated for the same or a prior control period equal to the amount of such already recorded CAIR NO X allowances. The CAIR designated representative shall ensure that there are sufficient CAIR NO X allowances in such account for completion of the deduction. (3) If the Administrator already recorded such CAIR NO X allowances under § 97.153 and if the Administrator makes such determination after making deductions for the source that includes such recipient under § 97.154(b) for the control period, then the Administrator will apply paragraph (e)(1) or (2) of this section, as appropriate, to any subsequent control period for which CAIR NO X allowances were allocated to such recipient. (4) The Administrator will transfer the CAIR NO X allowances that are not recorded, or that are deducted, in accordance with paragraphs (e)(1), (2), and (3) of this section to a new unit set-aside for the State in which such recipient is located." 40:40:23.0.1.1.1.15.1.4,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",EE,Subpart EE—CAIR NO,,§ 97.143 Compliance supplement pool.,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 71 FR 74795, Dec. 13, 2006]","(a) In addition to the CAIR NO X allowances allocated under § 97.142, the Administrator may allocate for the control period in 2009 up to the following amount of CAIR NO X allowances to CAIR NO X units in the respective State: (b) For any CAIR NO X unit in a State, if the unit's average annual NO X emission rate for 2007 or 2008 is less than 0.25 lb/mmBtu and, where such unit is included in a NO X averaging plan under § 76.11 of this chapter under the Acid Rain Program for such year, the unit's NO X averaging plan has an actual weighted average NO X emission rate for such year equal to or less than the actual weighted average NO X emission rate for the year before such year and if the unit achieves NO X emission reductions in 2007 and 2008, the CAIR designated representative of the unit may request early reduction credits, and allocation of CAIR NO X allowances from the compliance supplement pool under paragraph (a) of this section for such early reduction credits, in accordance with the following: (1) The owners and operators of such CAIR NO X unit shall monitor and report the NO X emissions rate and the heat input of the unit in accordance with subpart HH of this part in each control period for which early reduction credit is requested. (2) The CAIR designated representative of such CAIR NO X unit shall submit to the Administrator by May 1, 2009 a request, in a format specified by the Administrator, for allocation of an amount of CAIR NO X allowances from the compliance supplement pool not exceeding the sum of the unit's heat input for the control period in 2007 multiplied by the difference (if any greater than zero) between 0.25 lb/mmBtu and the unit's NO X emission rate for the control period in 2007 plus the unit's heat input for the control period in 2008 multiplied by the difference (if any greater than zero) between 0.25 lb/mmBtu and the unit's NO X emission rate for the control period in 2008, determined in accordance with subpart HH of this part and with the sum divided by 2,000 lb/ton and rounded to the nearest whole number of tons as appropriate. (c) For any CAIR NO X unit in a State whose compliance with the CAIR NO X emissions limitation for the control period in 2009 would create an undue risk to the reliability of electricity supply during such control period, the CAIR designated representative of the unit may request the allocation of CAIR NO X allowances from the compliance supplement pool under paragraph (a) of this section, in accordance with the following: (1) The CAIR designated representative of such CAIR NO X unit shall submit to the Administrator by May 1, 2009 a request, in a format specified by the Administrator, for allocation of an amount of CAIR NO X allowances from the compliance supplement pool not exceeding the minimum amount of CAIR NO X allowances necessary to remove such undue risk to the reliability of electricity supply. (2) In the request under paragraph (c)(1) of this section, the CAIR designated representative of such CAIR NO X unit shall demonstrate that, in the absence of allocation to the unit of the amount of CAIR NO X allowances requested, the unit's compliance with the CAIR NO X emissions limitation for the control period in 2009 would create an undue risk to the reliability of electricity supply during such control period. This demonstration must include a showing that it would not be feasible for the owners and operators of the unit to: (i) Obtain a sufficient amount of electricity from other electricity generation facilities, during the installation of control technology at the unit for compliance with the CAIR NO X emissions limitation, to prevent such undue risk; or (ii) Obtain under paragraphs (b) and (d) of this section, or otherwise obtain, a sufficient amount of CAIR NO X allowances to prevent such undue risk. (d) The Administrator will review each request under paragraph (b) or (c) of this section submitted by May 1, 2009 and will allocate CAIR NO X allowances for the control period in 2009 to CAIR NO X units in a State and covered by such request as follows: (1) Upon receipt of each such request, the Administrator will make any necessary adjustments to the request to ensure that the amount of the CAIR NO X allowances requested meets the requirements of paragraph (b) or (c) of this section. (2) If the State's compliance supplement pool under paragraph (a) of this section has an amount of CAIR NO X allowances not less than the total amount of CAIR NO X allowances in all such requests (as adjusted under paragraph (d)(1) of this section), the Administrator will allocate to each CAIR NO X unit covered by such requests the amount of CAIR NO X allowances requested (as adjusted under paragraph (d)(1) of this section). (3) If the State's compliance supplement pool under paragraph (a) of this section has a smaller amount of CAIR NO X allowances than the total amount of CAIR NO X allowances in all such requests (as adjusted under paragraph (d)(1) of this section), the Administrator will allocate CAIR NO X allowances to each CAIR NO X unit covered by such requests according to the following formula and rounding to the nearest whole allowance as appropriate: Unit's allocation = Unit's adjusted allocation × (State's compliance supplement pool ÷ Total adjusted allocations for all units) Where: “Unit's allocation” is the amount of CAIR NO X allowances allocated to the unit from the State's compliance supplement pool. “Unit's adjusted allocation” is the amount of CAIR NO X allowances requested for the unit under paragraph (b) or (c) of this section, as adjusted under paragraph (d)(1) of this section. “State's compliance supplement pool” is the amount of CAIR NO X allowances in the State's compliance supplement pool. “Total adjusted allocations for all units” is the sum of the amounts of allocations requested for all units under paragraph (b) or (c) of this section, as adjusted under paragraph (d)(1) of this section. Where: “Unit's allocation” is the amount of CAIR NO X allowances allocated to the unit from the State's compliance supplement pool. “Unit's adjusted allocation” is the amount of CAIR NO X allowances requested for the unit under paragraph (b) or (c) of this section, as adjusted under paragraph (d)(1) of this section. “State's compliance supplement pool” is the amount of CAIR NO X allowances in the State's compliance supplement pool. “Total adjusted allocations for all units” is the sum of the amounts of allocations requested for all units under paragraph (b) or (c) of this section, as adjusted under paragraph (d)(1) of this section. (4) By July 31, 2009, the Administrator will determine by order the allocations under paragraph (d)(2) or (3) of this section. The Administrator will make available to the public each determination of CAIR NO X allowances under such paragraph and will provide an opportunity for submission of objections to the determination. Objections shall be limited to addressing whether the determination is in accordance with paragraph (b) or (c) of this section and paragraph (d)(2) or (3) of this section, as appropriate. Based on any such objections, the Administrator will adjust each determination to the extent necessary to ensure that it is in accordance with such paragraphs. (5) By January 1, 2010, the Administrator will record the allocations under paragraph (d)(4) of this section." 40:40:23.0.1.1.1.15.1.5,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",EE,Subpart EE—CAIR NO,,§ 97.144 Alternative of allocation of CAIR NO,EPA,,,"[65 FR 2727, Jan. 18, 2000, as amended at 71 FR 74795, Dec. 13, 2006]","(a) Notwithstanding §§ 97.141, 97.142, and 97.153 if a State submits, and the Administrator approves, a State implementation plan revision in accordance with § 51.123(p)(1) of this chapter providing for allocation of CAIR NO X allowances by the permitting authority, then the permitting authority shall make such allocations in accordance with such approved State implementation plan revision, the Administrator will not make allocations under §§ 97.141 and 97.142 for the CAIR NO X units in the State, and under § 97.153, the Administrator will record the allocations made under such approved State implementation plan revision instead of allocations made under §§ 97.141 and 97.142. (b) Notwithstanding § 97.143, if a State submits, and the Administrator approves, a State implementation plan revision in accordance with § 51.123(p)(2) of this chapter providing for allocation of the State's compliance supplement pool by the permitting authority, then the permitting authority shall make such allocations in accordance with such approved State implementation plan revision, the Administrator will not make allocations under § 97.143(d)(4) for the CAIR NO X units in the State, and under § 97.143(d)(5), the Administrator will record the allocations of the State's compliance supplement pool made under such approved State implementation plan revision instead of allocations made under § 97.143(d)(4). (c)(1) In implementing paragraph (a) of this section and §§ 97.141, 97.142, and 97.153, the Administrator will ensure that the total amount of CAIR NO X allowances allocated, under such provisions and under a State's State implementation plan revision approved in accordance with § 51.123(p)(1) of this chapter, for a control period for CAIR NO X sources in the State or for other entities specified by the permitting authority will not exceed the State's State trading budget for the year of the control period. (2) In implementing paragraph (b) of this section and § 97.143, the Administrator will ensure that the total amount of CAIR NO X allowances allocated, under such provisions and under a State's State implementation plan revision approved in accordance with § 51.123(p)(2), for CAIR NO X sources in the State will not exceed the State's compliance supplement pool." 40:40:23.0.1.1.1.16.1.1,40,Protection of Environment,I,C,97,"PART 97—FEDERAL NOX BUDGET TRADING PROGRAM, CAIR NOX AND SO2 TRADING PROGRAMS, CSAPR NOX AND SO2 TRADING PROGRAMS, AND TEXAS SO2 TRADING PROGRAM",FF,Subpart FF—CAIR NO,,§ 97.150 [Reserved],EPA,,,,