cfr_sections
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41 rows where part_number = 79 and title_number = 40 sorted by section_id
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| 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 |
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| 40:40:19.0.1.1.1.1.1.1 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.1 Applicability. | EPA | The regulations of this part apply to the registration of fuels and fuel additives designated by the Administrator, pursuant to section 211 of the Clean Air Act (42 U.S.C. 1857f-6c, as amended by section 9, Pub. L. 91-604). | ||||
| 40:40:19.0.1.1.1.1.1.2 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.2 Definitions. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 59 FR 33092, June 27, 1994; 62 FR 12571, Mar. 17, 1997] | As used in this part, all terms not defined herein shall have the meaning given them in the Act: (a) Act means the Clean Air Act (42 U.S.C. 1857 et seq., as amended by Pub. L. 91-604). (b) Administrator means the Administrator of the Environmental Protection Agency. (c) Fuel means any material which is capable of releasing energy or power by combustion or other chemical or physical reaction. (d) Fuel manufacturer means any person who, for sale or introduction into commerce, produces, manufactures, or imports a fuel or causes or directs the alteration of the chemical composition of a bulk fuel, or the mixture of chemical compounds in a bulk fuel, by adding to it an additive, except: (1) A party (other than a fuel refiner or importer) who adds a quantity of additive(s) amounting to less than 1.0 percent by volume of the resultant additive(s)/fuel mixture is not thereby considered a fuel manufacturer. (2) A party (other than a fuel refiner or importer) who adds an oxygenate compound to fuel in any otherwise allowable amount is not thereby considered a fuel manufacturer. (e) Additive means any substance, other than one composed solely of carbon and/or hydrogen, that is intentionally added to a fuel named in the designation (including any added to a motor vehicle's fuel system) and that is not intentionally removed prior to sale or use. (f) Additive manufacturer means any person who produces, manufactures, or imports an additive for use as an additive and/or sells or imports for sale such additive under the person's own name. (g) Range of concentration means the highest concentration, the lowest concentration, and the average concentration of an additive in a fuel. (h) Chemical composition means the name and percentage by weight of each compound in an additive and the name and percentage by weight of each element in an additive. (i) Chemical structure means the molecular structure of a compound in an additive. (j) Impurity means any chemical element present in an additive that is not … | |||
| 40:40:19.0.1.1.1.1.1.3 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.3 Availability of information. | EPA | [59 FR 33092, June 27, 1994] | The availability to the public of information provided to, or otherwise obtained by, the Administrator under this part shall be governed by part 2 of this chapter except as expressly noted in subpart F of this part. | |||
| 40:40:19.0.1.1.1.1.1.4 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.4 Requirement of registration. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33092, June 27, 1994] | (a) Fuels. (1) No manufacturer of any fuel designated under this part shall, after the date prescribed for such fuel in this part, sell, offer for sale, or introduce into commerce such fuel unless the Administrator has registered such fuel. (2) No manufacturer of a registered fuel shall add or direct the addition to it of an additive which he has not previously reported unless he has notified the Administrator of such intended use, including the expected or estimated range of concentration. If necessary to meet an unforeseen production problem, however, a fuel manufacturer may use an additive that he has not previously reported provided that (i) the additive is on the current list of registered additives and (ii) the fuel manufacturer notifies the Administrator within 30 days regarding such unforeseen use and his plans regarding continued use, including the expected or estimated range of concentration. (3) Any designated fuel that is (i) in a research, development, or test status; (ii) sold to automobile, engine, or component manufacturers for research, development, or test purposes; or (iii) sold to automobile manufacturers for factory fill, and is not in any case offered for commercial sale to the public, shall be exempt from registration. (4) A domestic fuel manufacturer may purchase and offer for commercial sale foreign-produced fuel containing unidentified additives provided that within 30 days of his offer for sale he notifies the Administrator of the purchase, the source of purchase, the quantity purchased, and summarized results of any tests performed to determine the acceptability of the purchased fuel to the fuel manufacturer. (b) Additives. (1) No manufacturer of any fuel additive designated under this part shall, after the date by which the additive must be registered under this part, sell, offer for sale, or introduce into commerce such additive for use in any type of fuel designated under this part unless the Administrator has registered that additive for use in that type of fuel. (2) Any d… | |||
| 40:40:19.0.1.1.1.1.1.5 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.5 Periodic reporting requirements. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 79 FR 23630, Apr. 28, 2014; 85 FR 78463, Dec. 4, 2020] | (a) Fuel manufacturers. (1) For each calendar year (January 1 through December 31) commencing after the date prescribed for any fuel in subpart D of this part, fuel manufacturers must submit to the Administrator a report for each registered fuel showing the range of concentration of each additive reported under § 79.11(a) and the volume of such fuel produced in the year. Reports must be submitted by March 31 for the preceding year, or part thereof, on forms supplied by the Administrator. If the date prescribed for a particular fuel in subpart D of this part, or the later registration of a fuel is between October 1 and December 31, no report will be required for the period to the end of that year. Table 1 to § 79.5—Quarterly Reporting Deadlines (2) Fuel manufacturers shall submit to the Administrator a report annually for each registered fuel providing additional data and information as specified in §§ 79.32(c) and (d) and 79.33(c) and (d) in the designation of the fuel in subpart D of this part. Reports shall be submitted by March 31 for the preceding year, or part thereof, on forms supplied by the Administrator upon request. If the date prescribed for a particular fuel in subpart D of this part, or the later registration of a fuel is between October 1 and December 31, no report will be required for the period to the end of that year. (b) Additive manufacturers. Additive manufacturers shall submit to the Administrator a report annually for each registered additive providing additional data and information as specified in § 79.31(c) and (d) in the designation of the additive in subpart D of this part. Additive manufacturers shall also report annually the volume of each additive produced. Reports shall be submitted by March 31 for the preceding year, or part thereof, on forms supplied by the Administrator upon request. If the date prescribed for a particular additive in subpart D of this part, or the later registration of an additive is between October 1 and December 31, no report will be required for the pe… | |||
| 40:40:19.0.1.1.1.1.1.6 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.6 Requirement for testing. | EPA | [59 FR 33092, June 27, 1994] | Provisions regarding testing that is required for registration of a designated fuel or fuel additive are contained in subpart F of this part. | |||
| 40:40:19.0.1.1.1.1.1.7 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.7 Samples for test purposes. | EPA | When the Administrator requires for test purposes a fuel or additive which is not readily available in the open market, he may request the manufacturer of such fuel or additive to furnish a sample in a reasonable quantity. The fuel or additive manufacturer shall comply with such request within 30 days. | ||||
| 40:40:19.0.1.1.1.1.1.8 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | A | Subpart A—General Provisions | § 79.8 Penalties. | EPA | [58 FR 65554, Dec. 15, 1993, as amended at 89 FR 88655, Nov. 8, 2024] | Any person who violates section 211(a) of the Act or who fails to furnish any information or conduct any tests required under this part shall be liable to the United States for a civil penalty of not more than the sum of $25,000 for every day of such violation and the amount of economic benefit or savings resulting from the violation. Civil penalties shall be assessed in accordance with paragraphs (b) and (c) of section 205 of the Act. The civil monetary penalty amount listed in this section may not reflect recent inflation adjustments EPA is required to make. The current maximum and minimum statutory civil penalty amounts are located in § 19.4. | |||
| 40:40:19.0.1.1.1.2.1.1 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | B | Subpart B—Fuel Registration Procedures | § 79.10 Application for registration by fuel manufacturer. | EPA | [59 FR 33092, June 27, 1994] | Any manufacturer of a designated fuel who wishes to register that fuel shall submit an application for registration including all of the information set forth in § 79.11. If the manufacturer produces more than one grade or brand of a designated fuel, a manufacturer may include more than one grade or brand in a single application, provided that the application includes all information required for registration of each such grade or brand by this part. Each application shall be signed by the fuel manufacturer and shall be submitted on such forms as the Administrator will supply on request. | |||
| 40:40:19.0.1.1.1.2.1.2 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | B | Subpart B—Fuel Registration Procedures | § 79.11 Information and assurances to be provided by the fuel manufacturer. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 59 FR 33092, June 27, 1994] | Each application for registration submitted by the manufacturer of a designated fuel shall include the following: (a) The commercial identifying name of each additive that will or may be used in a designated fuel subsequent to the date prescribed for such fuel in subpart D; (b) The name of the additive manufacturer of each additive named; (c) The range of concentration of each additive named, as follows: (1) In the case of an additive which has been or is being used in the designated fuel, the range during any 3-month or longer period prior to the date of submission; (2) In the case of an additive which has not been used in the designated fuel, the expected or estimated range; (d) The purpose-in-use of each additive named; (e) The description (or identification, in the case of a generally accepted method) of a suitable analytical technique (if one is known) that can be used to detect the presence of each named additive in the designated fuel and/or to measure its concentration therein; (f) Such other data and information as are specified in the designation of the fuel in subpart D; (g) Assurances that the fuel manufacturer will notify the Administrator in writing and within a reasonable time of any change in: (1) The name of any additive previously reported; (2) The name of the manufacturer of any additive being used; (3) The purpose-in-use of any additive; (4) Information submitted pursuant to paragraph (e) of this section; (h) Assurances that the fuel manufacturer will not represent, directly or indirectly, in any notice, circular, letter, or other written communication, or any written, oral, or pictorial notice or other announcement in any publication or by radio or television, that registration of the fuel constitutes endorsement, certification, or approval by any agency of the United States; (i) The manufacturer of any fuel which will be sold, offered for sale, or introduced into commerce for use in motor vehicles manufactured after model year 1974 shall demonstrate that the fuel is substantia… | |||
| 40:40:19.0.1.1.1.2.1.3 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | B | Subpart B—Fuel Registration Procedures | § 79.12 Determination of noncompliance. | EPA | [59 FR 33093, June 27, 1994] | If the Administrator determines that an applicant for registration of a designated fuel has failed to submit all of the information required by § 79.11, or determines within the applicable period provided for Agency review that the applicant has not satisfactorily completed any testing which is required prior to registration of the fuel by any provision of subpart F of this part, he shall return the application to the manufacturer, along with an explanation of all deficiencies in the required information. | |||
| 40:40:19.0.1.1.1.2.1.4 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | B | Subpart B—Fuel Registration Procedures | § 79.13 Registration. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33093, June 27, 1994] | (a) If the Administrator determines that a manufacturer has submitted an application for registration of a designated fuel which includes all of the information and assurances required by § 79.11 and has satisfactorily completed all of the testing required by subpart F of this part, the Administrator shall promptly register the fuel and notify the fuel manufacturer of such registration. (b) The Administrator shall maintain a list of registered fuels, which shall be available to the public upon request. | |||
| 40:40:19.0.1.1.1.2.1.5 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | B | Subpart B—Fuel Registration Procedures | § 79.14 Termination of registration of fuels. | EPA | Registration may be terminated by the Administrator if the fuel manufacturer requests such termination in writing. | ||||
| 40:40:19.0.1.1.1.3.1.1 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | C | Subpart C—Additive Registration Procedures | § 79.20 Application for registration by additive manufacturer. | EPA | [59 FR 33093, June 27, 1994] | Any manufacturer of a designated fuel additive who wishes to register that additive shall submit an application for registration including all of the information set forth in § 79.21. Each application shall be signed by the fuel additive manufacturer and shall be submitted on such forms as the Administrator will supply on request. | |||
| 40:40:19.0.1.1.1.3.1.2 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | C | Subpart C—Additive Registration Procedures | § 79.21 Information and assurances to be provided by the additive manufacturer. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33093, June 27, 1994; 85 FR 78463, Dec. 4, 2020] | Each application for registration submitted by the manufacturer of a designated fuel additive shall include the following: (a) The chemical composition of the additive with the methods of analysis identified, except that (1) If the chemical composition is not known, full disclosure of the chemical process of manufacture will be accepted in lieu thereof; (2) In the case of an additive for engine oil, only the name, percentage by weight, and method of analysis of each element in the additive are required provided, however, that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided unless the breakdown into percentages for these individual elements is already known to the registrant. (3) In the case of a purchased component, only the name, manufacturer, and percent by weight of such purchased component are required if the manufacturer of the component will, upon request, furnish the Administrator with the chemical composition thereof. (b) The chemical structure of each compound in the additive if such structure is known and is not adequately specified by the name given under “chemical composition.” Nominal identification is adequate if mixed isomers are present. (c) The description (or identification, in the case of a generally accepted method) of a suitable analytical technique (if one is known) that can be used to detect the presence of the additive in any fuel named in the designation and/or to measure its concentration therein. (d) The specific types of fuels designated under § 79.32 for which the fuel additive will be sold, offered for sale, or introduced into commerce, and the fuel additive manufacturer's recommended range of concentration and purpose-in-use for each such type of fuel. (e) Such other data and information as are specified in the designation of the additive in subpart D. (f) Assurances that any change in information submitted pursuant to: (1) Paragraphs (a), (b), (c), (d), and (j) of this section will be provided to the Administrator in writin… | |||
| 40:40:19.0.1.1.1.3.1.3 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | C | Subpart C—Additive Registration Procedures | § 79.22 Determination of noncompliance. | EPA | [59 FR 33093, June 27, 1994] | If the Administrator determines that an applicant for registration of a designated fuel additive has failed to submit all of the information required by § 79.21, or determines within the applicable period provided for Agency review that the applicant has not satisfactorily completed any testing which is required prior to registration of the fuel additive by any provision of subpart F of this part, he shall return the application to the manufacturer, along with an explanation of all deficiencies in the required information. | |||
| 40:40:19.0.1.1.1.3.1.4 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | C | Subpart C—Additive Registration Procedures | § 79.23 Registration. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33093, June 27, 1994] | (a) If the Administrator determines that a manufacturer has submitted an application for registration of a designated fuel additive which includes all of the information and assurances required by § 79.21 and has satisfactorily completed all of the testing required by subpart F of this part, the Administrator shall promptly register the fuel additive and notify the fuel manufacturer of such registration. (b) The Administrator shall maintain a list of registered additives, which shall be available to the public upon request. | |||
| 40:40:19.0.1.1.1.3.1.5 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | C | Subpart C—Additive Registration Procedures | § 79.24 Termination of registration of additives. | EPA | [85 FR 78465, Dec. 4, 2020] | (a) Registration may be terminated by the Administrator if the additive manufacturer requests such termination in writing. (b) Registration for an additive that has its purpose-in-use identified as a deposit control additive for use in gasoline pursuant to the requirements of § 79.21(d) may be terminated by the Administrator if the EPA determines that the detergent additive is not compliant with the gasoline deposit control requirements of 40 CFR 1090.260. | |||
| 40:40:19.0.1.1.1.4.1.1 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | D | Subpart D—Designation of Fuels and Additives | § 79.30 Scope. | EPA | Fuels and additives designated and dates prescribed by the Administrator for the registration of such fuels and additives, pursuant to section 211 of the Act, are listed in this subpart. In addition, specific informational requirements under §§ 79.11(f) and 79.21(e) are set forth for each designated fuel or additive. Additional fuels and/or additives may be designated and pertinent dates and additional specific informational requirements prescribed as the Administrator deems advisable. | ||||
| 40:40:19.0.1.1.1.4.1.2 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | D | Subpart D—Designation of Fuels and Additives | § 79.31 Additives. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 43 FR 28490, June 30, 1978; 59 FR 33093, June 27, 1994] | (a) All additives produced or sold for use in motor vehicle gasoline and/or motor vehicle diesel fuel are hereby designated. The Act defines the term “motor vehicle” to mean any self-propelled vehicle designed for transporting persons or property on a street or highway. For purposes of this registration, however, additives specifically manufactured and marketed for use in motorcycle fuels are excluded. (b) All designated additives must be registered by July 7, 1976. (c) In accordance with §§ 79.5(b) and 79.21(e), and to the extent such information is known to the additive manufacturer as a result of testing conducted for reasons other than additive registration or reporting purposes, the additive manufacturer shall furnish the highest, lowest, and average values of the impurities in each designated additive, if greater than 0.1 percent by weight. The methods of analysis in making the determinations shall also be given. (d) In accordance with §§ 79.5(b) and 79.21(e), and to the extent such information is known to the additive manufacturer, he shall furnish summaries of any information developed by or specifically for him concerning the following items: (1) Mechanisms of action of the additive; (2) Reactions between the additive and the fuels listed in paragraph (a) of this section; (3) Identification and measurement of the emission products of the additive when used in the fuels listed in paragraph (a) of this section; (4) Effects of the additive on all emissions; (5) Toxicity and any other public health or welfare effects of the emission products of the additive; (6) Effects of the emission products of the additive on the performance of emission control devices/systems. Such submissions shall be accompanied by a description of the test procedures used in obtaining the information. Information will be considered to be known to the additive manufacturer if a report thereon has been prepared and circulated or distributed outside the research department or division. | |||
| 40:40:19.0.1.1.1.4.1.3 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | D | Subpart D—Designation of Fuels and Additives | § 79.32 Motor vehicle gasoline. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 85 FR 78465, Dec. 4, 2020] | (a) The following fuels commonly or commercially known or sold as motor vehicle gasoline are hereby individually designated: (1) Motor vehicle gasoline, unleaded—motor vehicle gasoline that contains no more than 0.05 gram of lead per gallon; (2) Motor vehicle gasoline, leaded, premium—motor vehicle gasoline that contains more than 0.05 gram of lead per gallon and is sold as “premium;” (3) Motor vehicle gasoline, leaded, non-premium—motor vehicle gasoline that contains more than 0.05 gram of lead per gallon but is not sold as “premium.” The Act defines the term “motor vehicle” to mean any self-propelled vehicle designed for transporting persons or property on a street or highway. For purposes of this registration, however, gasoline specifically blended and marketed for motorcycles is excluded. (b) All designated motor vehicle gasolines must be registered by September 7, 1976. (c) Fuel manufacturers must submit the reports specified in 40 CFR part 1090, subpart J. (d) In accordance with §§ 79.5(a)(2) and 79.11(f), and to the extent such information is known to the fuel manufacturer, he shall furnish summaries of any information developed by or specifically for him concerning the following items: (1) Mechanisms of action of each additive he reports; (2) Reactions between such additives and motor vehicle gasoline; (3) Identification and measurement of the emission products of such additives when used in motor vehicle gasoline; (4) Effects of such additives on all emissions; (5) Toxicity and any other public health or welfare effects of the emission products of such additives; (6) Effects of the emission products of such additives on the performance of emission control devices/systems. Such submissions shall be accompanied by a description of the test procedures used in obtaining the information. Information will be considered to be known to the fuel manufacturer if a report thereon has been prepared and circulated or distributed outside the research department or division. | |||
| 40:40:19.0.1.1.1.4.1.4 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | D | Subpart D—Designation of Fuels and Additives | § 79.33 Motor vehicle diesel fuel. | EPA | [40 FR 52011, Nov. 7, 1975, as amended at 85 FR 78465, Dec. 4, 2020] | (a) The following fuels commonly or commercially known or sold as motor vehicle diesel fuel are hereby individually designated: (1) Motor vehicle diesel fuel, grade 1-D; (2) Motor vehicle diesel fuel, grade 2-D. The Act defines the term “motor vehicle” to mean any self-propelled vehicle designed for transporting persons or property on a street or highway. (b) All designated motor vehicle diesel fuels must be registered within 12 months after promulgation of this part. (c) Fuel manufacturers must submit the reports specified in 40 CFR part 1090, subpart J. (d) In accordance with §§ 79.5(a)(2) and 79.11(f), and to the extent such information is known to the fuel manufacturer, he shall furnish summaries of any information developed by or specifically for him concerning the following items: (1) Mechanisms of action of each additive he reports; (2) Reactions between such additives and motor vehicle diesel fuel; (3) Identification and measurement of the emission products of such additives when used in motor vehicle diesel fuel; (4) Effects of such additives on all emissions; (5) Toxicity and any other public health or welfare effects of the emission products of such additives. Such submission shall be accompanied by a description of the test procedures used in obtaining the information. Information will be considered to be known to the fuel manufacturer if a report thereon has been prepared and circulated or distributed outside the research department or division. | |||
| 40:40:19.0.1.1.1.6.1.1 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.50 Definitions. | EPA | The definitions listed in this section apply only to subpart F of this part. Additive/base fuel mixture means the mixture resulting when a fuel additive is added in specified proportion to the base fuel of the fuel family to which the additive belongs. Aerosol additive means a chemical mixture in aerosol form generally used as a motor vehicle engine starting aid or carburetor cleaner and not recommended to be placed in the fuel tank. Aftermarket fuel additive means a product which is added by the end-user directly to fuel in a motor vehicle or engine to modify the performance or other characteristics of the fuel, the engine, or its emissions. Atypical element means any chemical element found in a fuel or additive product which is not allowed in the baseline category of the associated fuel family, and an “atypical fuel or fuel additive” is a product which contains such an atypical element. Base fuel means a generic fuel formulated from a set of specifications to be representative of a particular fuel family. Basic emissions means the total hydrocarbons, carbon monoxide, oxides of nitrogen, and particulates occurring in motor vehicle or engine emissions. Bulk fuel additive means a product which is added to fuel at the refinery as part of the original blending stream or after the fuel is transported from the refinery but before the fuel is purchased for introduction into the fuel tank of a motor vehicle. Emission characterization means the determination of the chemical composition of emissions. Emission generation means the operation of a vehicle or engine or the vaporization of a fuel or additive/fuel mixture under controlled conditions for the purpose of creating emissions to be used for testing purposes. Emission sampling means the removal of a fraction of collected emissions for testing purposes. Emission speciation means the analysis of vehicle or engine emissions to determine the individual chemical compounds which comprise those emissions. Engine Dynamometer Schedule (EDS) means the tr… | ||||
| 40:40:19.0.1.1.1.6.1.10 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.59 Reporting requirements. | EPA | [59 FR 33093, June 27, 1994, as amended at 62 FR 12572, 12576, Mar. 17, 1997; 85 FR 7069, Feb. 6, 2020] | (a) Timing. (1) The manufacturer of each designated fuel or fuel additive shall submit to EPA the basic registration data detailed in paragraph (b) of this section. Forms for submitting this data may be obtained from EPA at the following address: Attn: Fuel/Additives Registration, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Mail Code 6405A, Washington, DC 20460. (i) For existing products (pursuant to § 79.51(c)(1)), manufacturers shall submit the basic registration data as specified in § 79.59(b) to EPA by November 28, 1994. (ii) For registrable products (pursuant to § 79.51(c)(2)), manufacturers shall submit the basic registration data as specified in § 79.59(b) to apply for registration for such product. (iii) For new products (pursuant to § 79.51(c)(3)), manufacturers are strongly encouraged to notify EPA of an intent to obtain product registration by submitting the basic registration data as specified in § 79.59(b) prior to starting Tiers 1 and 2. (2) The information specified in paragraph (c) of this section shall be submitted to the address in paragraph (a)(1) of this section at the conclusion of activities performed in compliance with Tiers 1 and 2 under the provisions of §§ 79.52 and 79.53, according to the time constraints specified in § 79.51 (c) through (d). (3) The information specified in paragraph (d) of this section shall be submitted to EPA at the address in paragraph (a)(1) of this section at the conclusion of activities performed in compliance with Tier 3 under the provisions of § 79.54. (b) Basic Registration Data. Each manufacturer of a designated fuel or fuel additive shall submit the following data in regard to such fuel or fuel additive: (1) The information specified in § 79.11 or § 79.21. If such information has already been submitted to EPA in compliance with subpart B or C of this part, and if such previous information is accurate and up-to-date, the manufacturer need not resubmit this information. (2) Annual production volume of the fuel or fuel additiv… | |||
| 40:40:19.0.1.1.1.6.1.11 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.60 Good laboratory practices (GLP) standards for inhalation exposure health effects testing. | EPA | (a) General Provisions —(1) Scope. (i) This section prescribes good laboratory practices (GLPs) for conducting inhalation exposure studies relating to motor vehicle emissions health effects testing under this part. These directions are intended to ensure the quality and integrity of health effects data submitted pursuant to registration regulations issued under sections 211(b) or 211(e) of the Clean Air Act (CAA) (42 U.S.C. 7545). (ii) This section applies to any study described by paragraph (a)(1)(i) of this section which any person conducts, initiates, or supports on or after May 27, 1994. (iii) It is EPA's policy that all health effects data developed under sections 211(b) and (e) of CAA be in accordance with provisions of this section. If data are not developed in accordance with the provisions of this section, EPA may consider such data insufficient to evaluate the health effects of a motor vehicle's fuel or fuel additive emissions, unless the submitter provides additional information demonstrating that the data are reliable and adequate and EPA determines that the data are sufficient. (2) Definitions. As used in this section, the following terms shall have the meanings specified: Batch means a specific quantity or lot of a test fuel, additive/base fuel mixture, or reference substance that has been characterized according to § 79.60(f)(1)(i). CAA means the Clean Air Act. Carrier means any material which is combined with engine/motor vehicle emissions or a reference substance for administration to a test system. “Carrier” includes, but is not limited to, clean, filtered air, water, feed, and nutrient media. Control atmosphere means clean, filtered air which is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test atmosphere for chemical or biological measurements. Experimental start date means the first date the test atmosphere is applied to the test system. Experimental termination date means the last date on which da… | ||||
| 40:40:19.0.1.1.1.6.1.12 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.61 Vehicle emissions inhalation exposure guideline. | EPA | [59 FR 33093, June 27, 1994, as amended at 61 FR 58746, Nov. 18, 1996; 61 FR 36512, July 11, 1996] | (a) Purpose. This guideline provides additional information on methodologies required to conduct health effects tests involving inhalation exposures to vehicle combustion emissions from fuels or fuel/additive mixtures. Where this guideline and the other health effects testing guidelines in 40 CFR 79.62 through 79.68 specify differing values for the same test parameter, the specifications in the individual health test guideline shall prevail for that health effect endpoint. (b) Definitions. For the purposes of this section the following definitions apply. Acute inhalation study means a short-term toxicity test characterized by a single exposure by inhalation over a short period of time (at least 4 hours and less than 24 hours), followed by at least 14 days of observation. Aerodynamic diameter means the diameter of a sphere of unit density that has the same settling velocity as the particle of the test substance. It is used to compare particles of different sizes, densities and shapes, and to predict where in the respiratory tract such particles may be deposited. It applies to the size of aerosol particles. Chronic inhalation study means a prolonged and repeated exposure by inhalation for the life span of the test animal; technically, two years in the rat. Concentration means an exposure level. Exposure is expressed as weight or volume of test aerosol/substance per volume of air, usually mg/m 3 or as parts per million (ppm) over a given time period. Micrograms per cubic meter (µg/m 3 ) or parts per billion may be appropriate, as well. Cumulative toxicity means the adverse effects of repeated exposures occurring as a result of prolonged action or increased concentration of the administered test substance or its metabolites in the susceptible tissues. Inhalable diameter means that aerodynamic diameter of a particle which is considered to be inhalable for the organism. It is used to refer to particles which are capable of being inhaled and may be deposited anywhere within the respiratory tract from… | |||
| 40:40:19.0.1.1.1.6.1.13 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.62 Subchronic toxicity study with specific health effect assessments. | EPA | [59 FR 33093, June 27, 1994, as amended at 63 FR 63793, Nov. 17, 1998] | (a) Purpose —(1) General toxicity. This subchronic inhalation study is designed to determine a concentration-response relationship for potential toxic effects in rats resulting from continuous or repeated inhalation exposure to vehicle/engine emissions over a period of 90 days. A subgroup of perfusion-fixed animals is required, in addition to the main study population, for more exacting organ and tissue histology. This test will provide screening information on target organ toxicities and on concentration levels useful for running chronic studies and establishing exposure criteria. Initial information on effective concentrations/exposures of the test atmosphere may be determined from the literature of previous studies or through concentration range-finding trials prior to starting this study. This health effects screening test is not capable of directly determining those effects which have a long latency period for development (e.g., carcinogenicity and life-shortening), though it may permit the detremination of a no-observed-adverse-effect level, or NOAEL. (2) Specific health effects assessments (HEAs). These supplemental studies are designed to determine the potential for reproductive/teratologic, carcinogenic, mutagenic, and neurotoxic health effect outcomes from vehicle/engine emission exposures. They are done in combination with the subchronic toxicity study and paragraph (c) of this section or may be done separately as outlined by the appropriate test guideline. (i) Fertility assessment/teratology. The fertility assessment is an in vivo study designed to provide information on potential health hazards to the fetus arising from the mother's repeated exposure to vehicle/engine emissions before and during her pregnancy. By including a mating of test animals, the study provides preliminary data on the effects of repeated vehicle/engine emissions exposure on gonadal function, conception, and fertility. The fertility assessment/teratology guideline is found in § 79.63. (ii) Micronucleus (MN) Assay. … | |||
| 40:40:19.0.1.1.1.6.1.14 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.63 Fertility assessment/teratology. | EPA | [59 FR 33093, June 27, 1994, as amended at 61 FR 36513, July 11, 1996] | (a) Purpose. Fertility assessment/teratology is an in vivo study designed to provide information on potential health hazards to the fetus arising from the mother's repeated inhalation exposure to vehicle/engine emissions before and during her pregnancy. By including a mating of test animals, the study provides preliminary data on the effects of repeated vehicle/engine emissions exposure on gonadal function, conception, and fertility. Since this is a one-generation test that ends with examination of full-term fetuses, but not of live pups, it is not capable of determining effects on reproductive development which would only be detected in viable offspring of treated parents. (b) Definitions. For the purposes of this section, the following definitions apply: Developmental toxicity means the ability of an agent to induce in utero death, structural or functional abnormalities, or growth retardation after contact with the pregnant animal. Estrous cycle means the periodic recurrence of the biological phases of the female reproductive system which prepare the animal for conception and the development of offspring. The phases of the estrous cycle for a particular animal can be characterized by the general condition of the cells present in the vagina and the presence or absence of various cell types. Vaginal cytology evaluation means the use of wet vaginal cell smears to determine the phase of a test animal's estrous cycle and the potential for adverse exposure effects on the regularity of the animal's cycle. In the rat, common cell types found in the smears correlate well with the various stages of the estrous cycle and to changes occurring in the reproductive tract. (c) Principle of the test method. (1) For a two week period before exposures start, daily vaginal cell smears are examined from a surplus of female test animals to identify and cull those females which are acyclic. After culling, testers shall randomly assign at each exposure concentration (including unexposed) a minimum of twenty-five fema… | |||
| 40:40:19.0.1.1.1.6.1.15 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.64 | EPA | (a) Purpose. The micronucleus assay is an in vivo cytogenetic test which uses erythrocytes in the bone marrow of rodents to detect chemical damage to the chromosomes or mitotic apparatus of mammalian cells. As the erythroblast develops into an erythrocyte (red blood cell), its main nucleus is extruded and may leave a micronucleus in the cell body; a few micronuclei form under normal conditions in blood elements. This assay is based on an increase in the frequency of micronucleated erythrocytes found in bone marrow from treated animals compared to that of control animals. The visualization of micronuclei is facilitated in these cells because they lack a main nucleus. (b) Definitions. For the purposes of this section the following definitions apply: Micronuclei mean small particles consisting of acentric fragments of chromosomes or entire chromosomes, which lag behind at anaphase of cell division. After telophase, these fragments may not be included in the nuclei of daughter cells and form single or multiple micronuclei in the cytoplasm. Polychromatic erythrocyte (PCE) means an immature red blood cell that, because it contains RNA, can be differentiated by appropriate staining techniques from a normochromatic erythrocyte (NCE), which lacks RNA. In one to two days, a PCE matures into a NCE. (c) Test method —(1) Principle of the test method. (i) Groups of rodents are exposed by the inhalation route for a minimum of 6 hours/day over a period of not less than 28 days to three or more concentrations of a test substance in air. Groups of animals are sacrificed at the end of the exposure period and femoral bone marrow is extracted. The bone marrow is then smeared onto glass slides, stained, and PCEs are scored for micronuclei. Researchers may need to run a trial at the highest tolerated concentration of the test atmosphere to optimize the sample collection time for micronucleated cells. (ii) This assay may be done separately or in combination with the subchronic toxicity study, pursuant to the provisions i… | ||||
| 40:40:19.0.1.1.1.6.1.16 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.65 | EPA | (a) Purpose. The in vivo sister chromatid exchange (SCE) assay detects the ability of a chemical to enhance the exchange of DNA between two sister chromatids of a duplicating chromosome. The most commonly used assays employ mammalian bone marrow cells or peripheral blood lymphocytes, often from rodent species. (b) Definitions. For the purposes of this section, the following definitions apply: C-metaphase means a state of arrested cell growth typically seen after treatment with a spindle inhibitor, i.e., colchicine. Sister chromatid exchange means a reciprocal interchange of the two chromatid arms within a single chromosome. This exchange is visualized during the metaphase portion of the cell cycle and presumably requires the enzymatic incision, translocation and ligation of at least two DNA helices. (c) Test method —(1) Principle of the test method. (i) Groups of rodents are exposed by the inhalation route for a minimum of 6 hours/day over a period of not less than 28 days to three or more concentrations of a test substance in air. Groups of animals are sacrificed at the end of the exposure period and blood lymphocyte cell cultures are prepared from study animals. Cell growth is suspended after a time and cells are harvested, fixed and stained before scoring for SCEs. Researchers may need to run a trial at the highest tolerated concentration of the test atmosphere to optimize the sample collection time for second division metaphase cells. (ii) This assay may be done separately or in combination with the subchronic toxicity study, pursuant to the provisions in § 79.62. (2) Description. (i) The method described here employs peripheral blood lymphocytes (PBL) of laboratory rodents exposed to the test atmosphere. (ii) Within twenty-four hours of the last exposure, test animal lymphocytes are obtained by heart puncture and duplicate cell cultures are started for each animal. Cultures are grown in bromo-deoxyuridine (BrdU), and then a spindle inhibitor (e.g., colchicine) is added to arrest cell gr… | ||||
| 40:40:19.0.1.1.1.6.1.17 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.66 Neuropathology assessment. | EPA | [59 FR 33093, June 27, 1994, as amended at 63 FR 63793, Nov. 17, 1999] | (a) Purpose. (1) The histopathological and biochemical techniques in this guideline are designed to develop data in animals on morphologic changes in the nervous system associated with repeated inhalation exposures to motor vehicle emissions. These tests are not intended to provide a detailed evaluation of neurotoxicity. Neuropathological evaluation should be complemented by other neurotoxicity studies, e.g. behavioral and neurophysiological studies and/or general toxicity testing, to more completely assess the neurotoxic potential of an exposure. (2) [Reserved] (b) Definition. Neurotoxicity (NTX) or a neurotoxic effect is an adverse change in the structure or function of the nervous system following exposure to a chemical substance. (c) Principle of the test method. (1) Laboratory rodents are exposed to one of several concentration levels of a test atmosphere for at least six hours daily over a period of 90 days. At the end of the exposure period, the animals are anaesthetized, perfused in situ with fixative, and tissues in the nervous system are examined grossly and prepared for microscopic examination. Starting with the highest dosage level, tissues are examined under the light microscope for morphologic changes, until a no-observed-adverse-effect level is determined. In cases where light microscopy has revealed neuropathology, the NOAEL may be confirmed by electron microscopy. (2) The tests described herein may be combined with any other toxicity study, as long as none of the requirements of either are violated by the combination. Specifically, this assay may be combined with a subchronic toxicity study, pursuant to provisions in § 79.62. (d) Limit test. If a test at one dose level of the highest concentration that can be achieved while maintaining a particle size distribution with a mass median aerodynamic diameter (MMAD) of 4 micrometers (µm) or less, using the procedures described in paragraph (a) of this section, produces no observable toxic effects and if toxicity would not be expected bas… | |||
| 40:40:19.0.1.1.1.6.1.18 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.67 Glial fibrillary acidic protein assay. | EPA | (a) Purpose. Chemical-induced injury of the nervous system, i.e., the brain, is associated with astrocytic hypertrophy at the site of damage (see O'Callaghan, 1988 in paragraph (e)(3) in this section). Assays of glial fibrillary acidic protein (GFAP), the major intermediate filament protein of astrocytes, can be used to document this response. To date, a diverse variety of chemical insults known to be injurious to the central nervous system have been shown to increase GFAP. Moreover, increases in GFAP can be seen at concentrations below those necessary to produce cytopathology as determined by routine Nissl stains (standard neuropathology). Thus it appears that assays of GFAP represent a sensitive approach for documenting the existence and location of chemical-induced injury of the central nervous system. Additional functional, histopathological, and biochemical tests are necessary to assess completely the neurotoxic potential of any chemical. This biochemical test is intended to be used in conjunction with neurohistopathological studies. (b) Principle of the test method. (1) This guideline describes the conduct of a radioimmunoassay for measurement of the amount of GFAP in the brain of vehicle emission-exposed and unexposed control animals. It is based on modifications (O'Callaghan & Miller 1985 in paragraph (e)(5), O'Callaghan 1987 in paragraph (e)(1) of this section) of the dot-immunobinding procedure described by Jahn et al. (1984) in paragraph (e)(2) of this section. Briefly, brain tissue samples from study animals are assayed for total protein, diluted in dot-immunobinding buffer, and applied to nitrocellulose sheets. The spotted sheets are then fixed, blocked, washed and incubated in anti-GFAP antibody and [I 125 ] Protein A. Bound protein A is then quantified by gamma spectrometry. In lieu of purified protein standards, standard curves are constructed from dilution of a single control sample. By comparing the immunoreactivity of individual samples (both control and exposed groups) with that of t… | ||||
| 40:40:19.0.1.1.1.6.1.19 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.68 | EPA | [59 FR 33093, June 27, 1994, as amended at 61 FR 36513, July 11, 1996] | (a) Purpose. The Salmonella typhimurium histidine (his) reversion system is a microbial assay which measures his − → his + reversion induced by chemicals which cause base changes or frameshift mutations in the genome of the microorganism Salmonella typhimurium. (b) Definitions. For the purposes of this section, the following definitions apply: Base pair mutagen means an agent which causes a base change in DNA. In a reversion assay, this change may occur at the site of the original mutation or at a second site in the chromosome. Frameshift mutagen is an agent which causes the addition or deletion of single or multiple base pairs in the DNA molecule. Salmonella typhimurium reverse mutation assay detects mutation in a gene of a histidine-requiring strain to produce a histidine independent strain of this organism. (c) Reference substances. These may include, but need not be limited to, sodium azide, 2-nitrofluorene, 9-aminoacridine, 2-aminoanthracene, congo red, benzopurpurin 4B, trypan blue or direct blue 1. (d) Test method —(1) Principle. Motor vehicle combustion emissions from fuel or additive/base fuel mixtures are, first, filtered to trap particulate matter and, then, passed through a sorbent resin to trap semi-volatile gases. Bacteria are separately exposed to the extract from both the filtered particulates and the resin-trapped organics. Assays are conducted using both test mixtures with and without a metabolic activation system and exposed cells are plated onto minimal medium. After a suitable period of incubation, revertant colonies are counted in test cultures and compared to the number of spontaneous revertants in unexposed control cultures. (2) Description. Several methods for performing the test have been described. The procedures described here are for the direct plate incorporation method and the azo-reduction method. Among those used are: (i) Direct plate incorporation method; (ii) Preincubation method; (iii) Azo-reduction method; (iv) Microsuspension method; and (v) … | |||
| 40:40:19.0.1.1.1.6.1.2 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.51 General requirements and provisions. | EPA | [59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996; 62 FR 12575, Mar. 17, 1997; 85 FR 7069, Feb. 6, 2020; 89 FR 88655, Nov. 8, 2024] | (a) Overview of requirements. (1) All manufacturers of fuels and fuel additives that are designated for registration under this part are required to comply with the requirements of subpart F of this part either on an individual basis or as a participant in a group of manufacturers of the same or similar fuels and fuel additives, as defined in § 79.56. If manufacturers elect to comply by participation in a group, each manufacturer continues to be individually subject to the requirements of subpart F of this part, and responsible for testing under this subpart. Each manufacturer, subject to the provisions for group applications in § 79.51(b) and the special provisions in § 79.58, shall submit all Tier 1 and Tier 2 information required by §§ 79.52, 79.53 and 79.59 for each fuel or additive, except that the Tier 1 emission characterization requirements in § 79.52(b) and/or the Tier 2 testing requirements in § 79.53 may be satisfied by adequate existing information pursuant to the Tier 1 literature search requirements in § 79.52(d). The adequacy of existing information to serve in compliance with specific Tier 1 and/or Tier 2 requirements shall be determined according to the criteria and procedures specified in §§ 79.52(b) and 79.53 (c) and (d). In all cases, EPA reserves the right to require, based upon the information contained in the application or any other information available to the Agency, that manufacturers conduct additional testing of any fuel or additive (or fuel/additive group) if EPA determines that there is inadequate information upon which to base regulatory decisions for such product(s). In any case where EPA determines that the requirements of Tiers 1 and 2 have been satisfied but that further testing is required, the provisions of Tier 3 (§ 79.54) shall apply. (2) Laboratory facilities shall perform testing in compliance with Good Laboratory Practice (GLP) requirements as those requirements apply to inhalation toxicology studies. All studies shall be monitored by the facilities' Quality Assurance… | |||
| 40:40:19.0.1.1.1.6.1.3 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.52 Tier 1. | EPA | [59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996; 62 FR 12571, Mar. 17, 1997] | (a) General Specifications. Tier 1 requires manufacturers of designated fuels or fuel additives (or groups of manufacturers pursuant to § 79.56) to supply to the Administrator the identity and concentration of certain emission products of such fuels or additives and any available information regarding the health and welfare effects of the whole and speciated emissions of such fuels or additives. In addition to any information required under § 79.59 and in conformance with the reporting requirements thereof, manufacturers shall provide, pursuant to the timing provisions of § 79.51(c), the following information. (b) Emissions Characterization. Manufacturers must provide a characterization of the emission products which are generated by evaporation (if required pursuant to § 79.58(b)) and by combustion of the fuel or additive/base fuel mixture in a motor vehicle. For this purpose, manufacturers may perform the characterization procedures described in this section or may rely on existing emission characterization data. To be considered adequate in lieu of performing new emission characterization procedures, the data must be the result of tests using the product in question or using a fuel or additive/base fuel mixture meeting the same grouping criteria as the product in question. In addition, the emissions must be generated in a manner reasonably similar to those described in § 79.57, and the characterization procedures must be adequately performed and documented and must give results reasonably comparable to those which would be obtained by performing the procedures described herein. Reports of previous tests must be sufficiently detailed to allow EPA to judge the adequacy of protocols, techniques, and conclusions. After the manufacturer's submittal of such data, if EPA finds that the manufacturer has relied upon inadequate test data, then the manufacturer will not be considered to be in compliance until the corresponding tests have been conducted and the results submitted to EPA. (1) General Provisions. (i)… | |||
| 40:40:19.0.1.1.1.6.1.4 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.53 Tier 2. | EPA | (a) Generally. Subject to the provisions of § 79.53(b) through (d), the combustion emissions of each fuel or fuel additive subject to testing under this subpart must be tested in accordance with each of the testing guidelines in §§ 79.60 through 79.68, except that fuels and additives in the methane and propane fuel families (pursuant to § 79.56(e)(1)(v) and (vi)) need not undergo the Salmonella mutagenicity assay in § 79.68). Similarly, subject to the provisions of § 79.53(b) through (d), the evaporative emissions of each designated evaporative fuel and each designated evaporative fuel additive subject to testing under this subpart must be tested according to each of the testing guidelines in §§ 79.60 through 79.67 (excluding § 79.68, Salmonella typhimurium Reverse Mutation Assay). (b) Manufacturer Determination. Manufacturers shall determine whether the information gathered pursuant to the literature search in § 79.52(d) contains the results of adequately performed and adequately documented previous testing which provides information reasonably comparable to that supplied by the health tests described in §§ 79.62 through 79.68 regarding the carcinogenicity, mutagenicity, neurotoxicity, teratogenicity, reproductive/fertility measures, and general toxicity effects of the emissions of the fuel or additive. When manufacturers make an affirmative determination, they need submit only the information gathered pursuant to § 79.52(d) for such tests. EPA maintains final authority in judging whether the information is an adequate substitution in lieu of conducting the associated tests. EPA's determination of the adequacy of existing information shall be guided by the considerations described in paragraph (d) of this section. If EPA finds that the manufacturer has relied upon inadequate test data, then the manufacturer will not be considered to be in compliance until the corresponding tests have been conducted and the results submitted to EPA. (c) Testing. (1) All testing required pursuant to this section must be … | ||||
| 40:40:19.0.1.1.1.6.1.5 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.54 Tier 3. | EPA | (a) General Criteria for Requiring Tier 3 Testing. (1) Tier 3 testing shall be required of a manufacturer or group of manufacturers at EPA's discretion when remaining uncertainties as to the significance of observed health effects, welfare effects, and/or emissions exposures from a fuel or fuel/additive mixture interfere with EPA's ability to make reasonable estimates of the potential risks posed by emissions from the fuel or additive products. Tier 3 testing may be conducted either on an individual basis or a group basis. If performed on a group basis, EPA may require either the same representative to be used in Tier 3 testing as was used in Tier 2 testing or may select a different member or members of the group to represent the group in the Tier 3 tests. (2) In addition to the criteria specific to particular tests as summarized and detailed in the testing guidelines (§§ 79.62 through 79.68), EPA may consider a number of factors (including, but not limited to): (i) The number of positive and negative outcomes related to each endpoint; (ii) The identification of concentration-effect relationships; (iii) The statistical sensitivity and significance of such studies; (iv) The severity of the observed effects (e.g., whether the effects would be likely to lead to incapacitating or irreversible conditions); (v) The type and number of species included in the reported tests; (vi) The consistency and clarity of apparent mechanisms, target organs, and outcomes; (vii) The presence or absence of effective health test control data for base-fuel-only versus additive/base fuel mixture comparisons; (viii) The nature and amount of known toxic agents in the emissions stream; and (ix) The observation of lesions which specifically implicate inhalation as an important exposure route. (3) Consideration of exposure. EPA retains discretion to consider, in addition to available toxicity data, any Tier 1 data on potential exposures to emissions from a particular fuel or fuel additive (or group of fuels and/or fuel additives… | ||||
| 40:40:19.0.1.1.1.6.1.6 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.55 Base fuel specifications. | EPA | (a) General Characteristics. (1) The base fuel(s) in each fuel family shall serve as the group representative(s) for the baseline group(s) in each fuel family pursuant to § 79.56. Also, as specified in § 79.51(h)(1), for fuel additives undergoing testing, the designated base fuel for the respective fuel family shall serve as the substrate in which the additive shall be mixed prior to the generation of emissions. (2) Base fuels shall contain a limited complement of the additives which are essential for the fuel's production or distribution and/or for the successful operation of the test vehicle/engine throughout the mileage accumulation and emission generation periods. Such additives shall be used at the minimum effective concentration-in-use for the base fuel in question. (3) Unless otherwise restricted, the presence of trace contaminants does not preclude the use of a fuel or fuel additive as a component of a base fuel formulation. (4) When an additive is the test subject, any additive normally contained in the base fuel which serves the same function as the subject additive shall be removed from the base fuel formulation. For example, if a corrosion inhibitor were the subject of testing and if this additive were to be tested in a base fuel which normally contained a corrosion inhibitor, this test additive would replace the corrosion inhibitor normally included as a component of the base fuel. (5) Additive components of the methanol, ethanol, methane, and propane base fuels in addition to any such additives included below shall be limited to those recommended by the manufacturers of the vehicles and/or engines used in testing such fuels. For this purpose, EPA will review requests from manufacturers (or their agents) to modify the additive specifications for the alternative fuels and, if necessary, EPA shall change these specifications based on consistency of those changes with the associated vehicle manufacturer's recommendations for the operation of the vehicle. EPA shall publish notice of any such change… | ||||
| 40:40:19.0.1.1.1.6.1.7 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.56 Fuel and fuel additive grouping system. | EPA | [59 FR 33093, June 27, 1994, as amended at 62 FR 12571, Mar. 17, 1997] | (a) Manufacturers of fuels and fuel additives are allowed to satisfy the testing requirements in §§ 79.52, 79.53, and 79.54 and the associated reporting requirements in § 79.59 on an individual or group basis, provided that such products meet the criteria in this section for enrollment in the same fuel/additive group. However, each manufacturer of a fuel or fuel additive must individually comply with the notification requirements of § 79.59(b). Further, if a manufacturer elects to comply by participation in a group, each manufacturer continues to be individually subject to the information requirements of this subpart. (1) The use of the grouping provision to comply with Tier 1 and Tier 2 testing requirements is voluntary. No manufacturer is prohibited from testing and submitting its own data for its own product registration, despite its qualification for membership in a particular group. (2) The only groups permitted are those established in this section. (b) Each manufacturer who chooses to enroll a fuel or fuel additive in a group of similar fuels and fuel additives as designated in this section may satisfy the registration requirements through a group submission of jointly-sponsored testing and analysis conducted on a product which is representative of all products in that group, provided that the group representative is chosen according to the specifications in this section. (1) The health effects information submitted by a group shall be considered applicable to all fuels and fuel additives in the group. A fuel or fuel additive manufacturer who has chosen to participate in a group may subsequently choose to perform testing of such fuel or fuel additive on an individual basis; however, until such independent registration information has been received and reviewed by EPA, the information initially submitted by the group on behalf of the manufacturer's fuel or fuel additive shall be considered applicable and valid for that fuel or fuel additive. It could therefore be used to support requirements for further… | |||
| 40:40:19.0.1.1.1.6.1.8 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.57 Emission generation. | EPA | [59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996; 63 FR 63792, Nov. 17, 1998] | This section specifies the equipment and procedures that must be used in generating the emissions which are to be subjected to the characterization procedures and/or the biological tests specified in §§ 79.52(b) and 79.53 of these regulations. When applicable, they may also be required in conjunction with testing under §§ 79.54 and 79.58(c). Additional requirements concerning emission generation, delivery, dilution, quality control, and safety practices are outlined in § 79.61. (a) Vehicle and engine selection criteria. (1) All vehicles and engines used to generate emissions for testing a fuel or additive/fuel mixture must be new (i.e., never before titled) and placed into the program with less than 500 miles on the odometer or 12 hours on the engine chronometer. The vehicles and engines shall be unaltered from the specifications of the original equipment manufacturer. (2) The vehicle/engine type, vehicle/engine class, and vehicle/engine subclass designated to generate emissions for a given fuel or additive shall be the same type, class, and subclass which, over the previous three years, has consumed the most gallons of fuel in the fuel family applicable to the given fuel or additive. No distinction shall be made between light-duty vehicles and light-duty trucks for purposes of this classification. (3) Within this vehicle/engine type, class, and subclass, the specific vehicles and engines acceptable for emission generation are those that represent the most common fuel metering system and the most common of the most important emission control system devices or characteristics with respect to emission reduction performance for the model year in which testing begins. These vehicles will be determined through a survey of the previous model year's vehicle/engine sales within the given subclass. These characteristics shall include, but need not be limited to, aftertreatment device(s), fuel aspiration, air injection, exhaust gas recirculation, and feedback type. (4) Within the applicable subclass, the five highest… | |||
| 40:40:19.0.1.1.1.6.1.9 | 40 | Protection of Environment | I | C | 79 | PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES | F | Subpart F—Testing Requirements for Registration | § 79.58 Special provisions. | EPA | [59 FR 33093, June 27, 1994, as amended at 62 FR 12571, Mar. 17, 1997] | (a) Relabeled Additives. Sellers of relabeled additives (pursuant to § 79.50) are not required to comply with the provisions of § 79.52, 79.53 or 79.59, except that such sellers are required to comply with § 79.59(b). (b) Low Vapor Pressure Fuels and Additives. Fuels which are not designated as “evaporative fuels” and fuel additives which are not designated as “evaporative fuel additives” pursuant to the definitions in § 79.50 need not undergo the emission characterization or health effects testing specified in §§ 79.52 and 79.53 for evaporative emissions. At EPA's discretion, the evaporative emissions of such fuels and additives may be required to undergo Tier 3 testing, pursuant to § 79.54. (c) Alternative Tier 2 Provisions. At EPA's discretion, EPA may modify the standard Tier 2 health effects testing requirements for a fuel or fuel additive (or group). Such modification may encompass substitution, addition, or deletion of Tier 2 studies or study specifications, and/or changes in underlying engine or equipment requirements, except that a Tier 2 endpoint will not be deleted in the absence of existing information deemed adequate by EPA or alternative testing requirements for such endpoint. If warranted by the particular requirements, EPA will allow additional time for completion of the alternative Tier 2 testing program. (1) When EPA intends to require testing in lieu of or in addition to standard Tier 2 health testing, EPA will notify the responsible manufacturer (or group) by certified letter of the specific tests which EPA is proposing to require in lieu of or in addition to Tier 2, and the proposed schedule for completion and submission of such tests. A copy of the letter will be placed in the public record. EPA intends to send the notification prior to November 27, 1995, or in the case of new fuels and additives (as defined in § 79.51(c)(3)), within 18 months of EPA's receipt of an intent to register such product. However, EPA's notification to the manufacturer (or group) may occur at any time up t… |
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