40 C.F.R. PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES
Title 40 - Protection of Environment
Authority: 42 U.S.C. 7414, 7524, 7545 and 7601.
Source: 40 FR 52011, Nov. 7, 1975, unless otherwise noted.
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). 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 included in the chemical formula or identified in the breakdown by element in the chemical composition of such additive. (k) Oxygenate compound means an oxygen-containing, ashless organic compound, such as an alcohol or ether, which may be used as a fuel or fuel additive. [40 FR 52011, Nov. 7, 1975, as amended at 59 FR 33092, June 27, 1994; 62 FR 12571, Mar. 17, 1997] 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. [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 designated additive that is either (i) in a research, development, or test status or (ii) sold to petroleum, automobile, engine, or component manufacturers for research, development, or test purposes, and in either case is not offered for commercial sale to the public, shall be exempt from registration. (3) Process chemicals used by refineries during the refinery process are exempted from the requirement for registration. (4) If an additive manufacturer prepares for sale only to fuel manufacturers (i) a blend or mixture of two or more registered additives or (ii) a blend or mixture of one or more registered additives with one or more substances containing only carbon and/or hydrogen, he will not be required to register such blend or mixture provided he will, upon request, furnish the Administrator with the names and percentages by weight of all components of such blend or mixture. [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33092, June 27, 1994] (a) Fuel manufacturers. (1) For each calendar quarter (January through March, April through June, July through September, October through December) commencing after the date prescribed for a particular fuel in subpart D, fuel manufacturers shall submit to the Administrator a report for each registered fuel showing (i) the range of concentration of each additive reported under §79.11(a) and (ii) the volume of such fuel produced in the quarter. Reports shall be submitted within 45 days after the close of the reporting period on forms supplied by the Administrator upon request. (2) Fuel manufacturers shall submit to the Administrator a report annually for each registered fuel providing additional data and information as specified in §79.31(c) and (d) in the designation of the fuel in subpart D. Reports shall be submitted on or before 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 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 paragraphs (c) and (d) in the designation of the additive in subpart D. Additive manufacturers shall also report annually the volume of each additive produced. Reports shall be submitted on or before 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 or the later registration of an additive is between October 1 and December 31, no report will be required for the period to the end of that year. These periodic reports shall not, however, be required for any additive that is: (1) An additive registered under another name, (2) A blend or mixture of two or more registered additives, or (3) A blend or mixture of one or more registered additives with one or more substances containing only carbon and/or hydrogen. Provisions regarding testing that is required for registration of a designated fuel or fuel additive are contained in subpart F of this part. [59 FR 33092, June 27, 1994] 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. 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. [58 FR 65554, Dec. 15, 1993] 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. [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 substantially similar to any fuel utilized in the certification of any 1975 or subsequent model year vehicle or engine, or that the manufacturer has obtained a waiver under 42 U.S.C. 7545(f)(4); and (j) The manufacturer shall submit, or shall reference prior submissions, including all of the test data and other information required prior to registration of the fuel by the provisions of subpart F of this part. [40 FR 52011, Nov. 7, 1975, as amended at 59 FR 33092, 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. [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 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33093, June 27, 1994] Registration may be terminated by the Administrator if the fuel manufacturer requests such termination in writing. 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. [59 FR 33093, June 27, 1994] 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), and (d) of this section will be provided to the Administrator in writing within 30 days of such change; and (2) paragraph (e) of this section as provided in §79.5(b). (g) Assurances that the additive 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 additive constitutes endorsement, certification, or approval by any agency of the United States. (h) The manufacturer of any fuel additive which will be sold, offered for sale, or introduced into commerce for use in any type of fuel intended for use in motor vehicles manufactured after model year 1974 shall demonstrate that the fuel additive, when used at the recommended range of concentration, is substantially similar to any fuel additive included in a fuel utilized in the certification of any 1975 or subsequent model year vehicle or engine, or that the manufacturer has obtained a waiver under 42 U.S.C. 7545(f)(4). (i) The manufacturer shall submit, or shall reference prior submissions, including all of the test data and other information required prior to registration of the fuel additive by the provisions of subpart F of this part. [40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 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. [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 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33093, June 27, 1994] Registration may be terminated by the Administrator if the additive manufacturer requests such termination in writing. 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. (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. (Secs. 211, 301(a), Clean Air Act as amended (40 U.S.C. 7545, 7601(a))) [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) 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) In accordance with §§79.5(a)(2) and 79.11(f), and to the extent such information is known to the fuel manufacturer as a result of testing conducted for reasons other than fuel registration or reporting purposes, the fuel manufacturer shall furnish the data listed below. The highest, lowest, and average values of the listed characteristics/properties are to be reported. For initial registration, data shall be given for any 3-month or longer period prior to the date of submission. For annual reports thereafter, data shall be for the calendar year, except that if the first required annual report covers a period of less than a year, the data may be for such shorter period. (1) Hydrocarbon composition (aromatic content, olefin content, saturate content), with the methods of analysis identified; (2) Polynuclear organic material content, sulfur content, and trace element content, with the methods of analysis identified; (3) Reid vapor pressure; (4) Distillation temperatures (10 percent point, end point); (5) Research octane number and motor octane number. (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 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976] (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) In accordance with §§79.5(a)(2) and 79.11(f), and to the extent such information is known to the fuel manufacturer as a result of testing conducted for reasons other than fuel registration or reporting purposes, the fuel manufacturer shall furnish the data listed below. The highest, lowest, and average values of the listed characteristics/properties are to be reported. For initial registration, data shall be given for any 3-month or longer period prior to the date of submission. For annual reports thereafter, data shall be for the calendar year, except that if the first required annual report covers a period of less than a year, the data may be for such shorter period. (1) Hydrocarbon composition (aromatic content, olefin content, saturate content), with the methods of analysis identified; (2) Polynuclear organic material content, sulfur content, and trace element content, with the methods of analysis identified; (3) Distillation temperatures (90 percent point, end point); (4) Cetane number or cetane index; (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. Source: 59 FR 33093, June 27, 1994, unless otherwise noted.
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 transient engine speed versus torque time sequence commonly used in heavy-duty engine evaluation. The EDS for heavy-duty diesel engines is specified in 40 CFR part 86, appendix I(f)(2). Evaporative Emission Generator (EEG) means a fuel tank or vessel to which heat is applied to cause a portion of the fuel to evaporate at a desired rate. Evaporative emissions means chemical compounds emitted into the atmosphere by vaporization of contents of a fuel or additive/fuel mixture. Evaporative fuel means a fuel which has a Reid Vapor Pressure (RVP, pursuant to 40 CFR part 80, appendix “E”) of 2.0 pounds per square inch or greater and is not supplied to motor vehicle engines by way of sealed containment and delivery systems. Evaporative fuel additive means a fuel additive which, when mixed with its specified base fuel, causes an increase in the RVP of the base fuel by 0.4 psi or more relative to the RVP of the base fuel alone and results in an additive/base fuel mixture whose RVP is 2.0 psi, or greater. Excluded from this definition are fuel additives used with fuels which are supplied to motor vehicle engines by way of sealed containment and delivery systems. Federal Test Procedure (FTP) means the body of exhaust and evaporative emissions test procedures described in 40 CFR 86 for the certification of new motor vehicles to Federal motor vehicle emissions standards. Fuel family means a set of fuels and fuel additives which share basic chemical and physical formulation characteristics and can be used in the same engine or vehicle. Manufacturer means a person who is a fuel manufacturer or additive manufacturer as defined in §79.2 (d) and (f). Nitrated polycyclic aromatic hydrocarbons (NPAH) means the class of compounds whose molecular structure includes two or more aromatic rings and contains one or more nitrogen substitutions. Non-catalyzed emissions means exhaust emissions not subject to an effective aftertreatment device such as a functional catalyst or particulate trap. Oxygenate compound means an oxygen-containing, ashless organic compound, such as an alcohol or ether, which may be used as a fuel or fuel additive. Polycyclic aromatic hydrocarbons (PAH) means the class of hydrocarbon compounds whose molecular structure includes two or more aromatic rings. Relabeled additive means a fuel additive which is registered by its original manufacturer with EPA and is also registered and sold, unchanged in composition, under a different label and/or by a different entity. Semi-volatile organic compounds means that fraction of gaseous combustion emissions which consists of compounds with greater than twelve carbon atoms and can be trapped in sorbent polymer resins. Urban Dynamometer Driving Schedule (UDDS) means the 1372 second transient speed driving sequence used by EPA to simulate typical urban driving. The UDDS for light-duty vehicles is described in 40 CFR part 86, appendix I(a). Vapor phase means the gaseous fraction of combustion emissions. Vehicle classes/subclasses means the divisions of vehicle groups within a vehicle type, including light-duty vehicles, light-duty trucks, and heavy-duty vehicles as specified in 40 CFR part 86. Vehicle type means the divisions of motor vehicles according to combustion cycle and intended fuel class, including, but not necessarily limited to, Otto cycle gasoline-fueled vehicles, Otto cycle methanol-fueled vehicles, diesel cycle diesel-fueled vehicles, and diesel cycle methanol-fueled vehicles. Whole emissions means all components of unfiltered combustion emissions or evaporative emissions. (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 units (as specified in §79.60). (b) Group Applications. Subject to the provisions of §79.56 (a) through (c), EPA will consider any testing requirements of this subpart to have been met for any fuel or fuel additive when a fuel or fuel additive which meets the criteria for inclusion in the same group as the subject fuel or fuel additive has met that testing requirement, provided that all fuels and additives must be individually registered as described in §79.59(b). For purposes of this subpart, a determination of which group contains a particular fuel or additive will be made pursuant to the provisions of §79.56 (d) and (e). Nothing in this subsection (b) shall be deemed to require a manufacturer to rely on another manufacturer's testing. (c) Application Procedures and Dates. Each application submitted in compliance with this subpart shall be signed by the manufacturer of the designated fuel or additive, or by the manufacturer's agent, and shall be submitted to the address and in the format prescribed in §79.59. A manufacturer who chooses to comply as part of a group pursuant to §79.56 shall be covered by the group's joint application. Subject to any modifications pursuant to the special provisions in §§79.51(f) or 79.58, the schedule for compliance with the requirements of this subpart is as follows: (1) Fuels and fuel additives with existing registrations. (i) The manufacturer of a fuel or fuel additive product which, pursuant to subpart B or C of this part, is registered as of May 27, 1994 must submit the additional basic registration data specified in §79.59(b) before November 28, 1994. (ii) Except as provided in paragraphs (c)(1)(vi) and (vii) of this section, the manufacturer of such products must also satisfy the requirements and time schedules in either of the following paragraphs (c)(1)(ii) (A) or (B) of this section: (A) No later than May 27, 1997, all applicable Tier 1 and Tier 2 requirements must be submitted to EPA, pursuant to §§79.52, 79.53, and 79.59; or (B) No later than May 27, 1997, all applicable Tier 1 requirements (pursuant to §§79.52 and 79.59), plus evidence of a contract with a qualified laboratory (or other suitable arrangement) for completion of all applicable Tier 2 requirements, must be submitted to EPA. For this purpose, a qualified laboratory is one which can demonstrate the capabilities and credentials specified in §79.53(c)(1). In addition, by May 26, 2000, all applicable Tier 2 requirements (pursuant to §§79.53 and 79.59) must be submitted to EPA. (iii) In the case of such fuels and fuel additives which, pursuant to applicable special provisions in §79.58, are not subject to Tier 2 requirements, all other requirements (except Tier 3) must be submitted to EPA before May 27, 1997. (iv) In the event that Tier 3 testing is also required (under §79.54), EPA shall determine an appropriate timeline for completion of the additional requirements and shall communicate this schedule to the manufacturer according to the provisions of §79.54(b). (v) The manufacturer may at any time modify an existing fuel registration by submitting a request to EPA to add or delete a bulk additive to the existing registration information for such fuel product, provided that any additional additive must be registered by EPA for use in the specific fuel family to which the fuel product belongs. However, the addition or deletion of a bulk additive to a fuel registration may effect the grouping of such registered fuel under the criteria of §79.56, and thus may effect the testing responsibilities of the fuel manufacturer under this subpart. (vi) In regard to atypical fuels or additives in the gasoline and diesel fuel families (pursuant to the specifications in §79.56(e)(4)(iii)(A) (1) and (2)): (A) All applicable Tier 1 requirements, pursuant to §§79.52 and 79.59, must be submitted to EPA by May 27, 1997. (B) Tier 2 requirements, pursuant to §§79.53 and 79.59, must be satisfied according to the deadlines in either of the following paragraphs (c)(1)(vi)(B) (1) or (2) of this section: (1) All applicable Tier 2 requirements shall be submitted to EPA by November 27, 1998; or (2) Evidence of a contract with a qualified laboratory (or other suitable arrangement) for completion of all applicable Tier 2 requirements shall be submitted to EPA by November 27, 1998. For this purpose, a qualified laboratory is one which can demonstrate the capabilities and credentials specified in §79.53(c)(1). In addition, all applicable Tier 2 requirements must be submitted to EPA by November 27, 2001. (vii) In regard to nonbaseline diesel products formulated with mixed alkyl esters of plant and/or animal origin (i.e., “biodiesel” fuels, pursuant to §79.56(e)(4)(ii)(B)(2)): (A) All applicable Tier 1 requirements, pursuant to §§79.52 and 79.59, must be submitted to EPA by March 17, 1998. (B) Tier 2 requirements, pursuant to §§79.53 and 79.59, must be satisfied according to the deadlines in either of the following paragraphs (c)(1)(vii)(B) (1) or (2) of this section: (1) All applicable Tier 2 requirements shall be submitted to EPA by March 17, 1998; or (2) Evidence of a contract with a qualified laboratory (or other suitable arrangement) for completion of all applicable Tier 2 requirements shall be submitted to EPA by March 17, 1998. For this purpose, a qualified laboratory is one which can demonstrate the capabilities and credentials specified in §79.53(c)(1). In addition, all applicable Tier 2 requirements must be submitted to EPA by May 27, 2000. (2) Registrable fuels and fuel additives. (i) A fuel product which is not registered pursuant to subpart B of this part as of May 27, 1994 shall be considered registrable if, under the criteria established by §79.56, the fuel can be enrolled in the same fuel/additive group with one or more currently registered fuels. A fuel additive product which is not registered for a specific type of fuel pursuant to subpart C of this part as of May 27, 1994 shall be considered registrable for that type of fuel if, under the criteria established by §79.56, the fuel/additive mixture resulting from use of the additive product in the specific type of fuel can be enrolled in the same fuel/additive group with one or more currently registered fuels or bulk fuel additives. For the purpose of this determination, currently registered fuels and bulk additives are those with existing registrations as of the date on which EPA receives the basic registration data (pursuant to §79.59(b)) for the product in question. (ii) A manufacturer seeking to register under subpart B of this part a fuel product which is deemed registrable under this section, or to register under subpart C of this part a fuel additive product for a specific type of fuel for which it is deemed registrable under this section, shall submit the basic registration data (pursuant to §79.59(b)) for that product as part of the application for registration. If the Administrator determines that the product is registrable under this section, then the Administrator shall promptly register the product, provided that the applicant has satisfied all of the other requirements for registration under subpart B or subpart C of this part, and contingent upon satisfactory submission of required information under paragraph (c)(2)(iii) of this section. (iii) Registration of a registrable fuel or additive shall be subject to the same requirements and compliance schedule as specified in paragraph (c)(1) of this section for existing fuels and fuel additives. Accordingly, manufacturers of registrable fuels or additives may be granted and may retain registration for such products only if any applicable and due Tier 1, 2, and 3 requirements have also been satisfied by either the manufacturer of the product or the fuel/additive group to which the product belongs. (3) New fuels and fuel additives. A fuel product shall be considered new if it is not registered pursuant to subpart B of this part as of May 27, 1994 and if, under the criteria established by §79.56, it cannot be enrolled in the same fuel/additive group with one or more currently registered fuels. A fuel additive product shall be considered new with respect to a specific type of fuel if it is not expressly registered for that type of fuel pursuant to subpart C of this part as of May 27, 1994 and if, under the criteria established by §79.56, the fuel/additive mixture resulting from use of the additive product in the specific type of fuel cannot be enrolled in the same fuel/additive group with one or more currently registered fuels or bulk fuel additives. For the purpose of this determination, currently registered fuels and bulk additives are those with existing registrations as of the date on which EPA receives the basic registration data (pursuant to §79.59(b)) for the product in question. For such new product, the manufacturer must satisfactorily complete all applicable Tier 1 and Tier 2 requirements, followed by any Tier 3 testing which the Administrator may require, before registration will be granted. (d) Notifications. Upon receipt of a manufacturer's (or group's) submittal in compliance with the requirements of this subpart, EPA will notify such manufacturer (or group) that the application has been received and what, if any, information, testing, or retesting is necessary to bring the application into compliance with the requirements of this subpart. EPA intends to provide such notification of receipt in a timely manner for each such application. (1) Registered fuel and fuel additive notification. (i) The manufacturer of a registered fuel or fuel additive product who is notified that the submittal for such product contains adequate information pursuant to the Tier 1 and Tier 2 testing and reporting requirements (§§79.52, 79.53, and 79.59 (a) through (c)) may continue to sell, offer for sale, or introduce into commerce the registered product as permitted by the existing registration for the product under §79.4. (ii) If the manufacturer of a registered fuel or fuel additive product is notified that testing or retesting is necessary to bring the Tier 1 and/or Tier 2 submittal into compliance, the continued sale or importation of the product shall be conditional upon satisfactorily completing the requirements within the time frame specified in paragraph (c)(1) of this section. (iii) EPA intends to notify the manufacturer of the adequacy of the submitted data within two years of EPA's receipt of such data. However, EPA retains the right to require that adequate data be submitted to EPA if, upon subsequent review, EPA finds that the original Tier 1 and/or Tier 2 submittal is not consistent with the requirements of this subpart. If EPA does not notify the manufacturer of the adequacy of the Tier 1 and/or Tier 2 data within two years, EPA will not hold the manufacturer liable for penalties for violating this rule for the period beginning when the data was due until the time EPA notifies the manufacturer of the violation. (iv) If the manufacturer of a registered fuel or fuel additive product is notified (pursuant to §79.54(b)) that Tier 3 testing is required for its product, then the manufacturer may continue to sell, offer for sale, introduce into commerce the registered product as permitted by the existing registration for the product under §79.4. However, if the manufacturer fails to complete the specified Tier 3 requirements within the specified time, the registration of the product will be subject to cancellation under §79.51(f)(6). (v) EPA retains the right to require additional Tier 3 testing pursuant to the procedures in §79.54. (2) New fuel and fuel additive notification. (i) Within six months following its receipt of the Tier 1 and Tier 2 submittal for a new product (as defined in paragraph (c)(3) of this section), EPA shall notify the manufacturer of the adequacy of such submittal in compliance with the requirements of §§79.52, 79.53, and 79.59 (a) through (c). (A) If EPA notifies the manufacturer that testing, retesting, or additional information is necessary to bring the Tier 1 and Tier 2 submittal into compliance, the manufacturer shall remedy all inadequacies and provide Tier 3 data, if required, before EPA shall consider the requirements for registration to have been met for the product in question. (B) If EPA does not notify the manufacturer of the adequacy of the Tier 1 and Tier 2 submittal within six months following the submittal, the manufacturer shall be deemed to have satisfactorily completed Tiers 1 and 2. (ii) Within six months of the date on which EPA notifies the manufacturer of satisfactory completion of Tiers 1 and 2 for a new product, or within one year of the submittal of the Tier 1 and Tier 2 data (whichever is earlier), EPA shall determine whether additional testing is currently needed under the provisions of Tier 3 and, pursuant to §79.54(b), shall notify the manufacturer of its determination. (A) If the manufacturer of a new fuel or fuel additive product is notified that Tier 3 testing is required for such product, then EPA shall have the authority to withhold registration until the specified Tier 3 requirements have been satisfactorily completed. EPA shall determine whether the Tier 3 requirements have been met, and shall notify the manufacturer of this determination, within one year of receiving the manufacturer's Tier 3 submittal. (B) If EPA does not notify the manufacturer of potential Tier 3 requirements within the prescribed timeframe, then additional testing at the Tier 3 level is deemed currently unnecessary and the manufacturer shall be considered to have complied with all current registration requirements for the new fuel or additive product. (iii) Upon completion of all current Tier 1, Tier 2, and Tier 3 requirements, and submission of an application for registration which includes all of the information and assurances required by §79.11 or §79.21, the registration of the new fuel or additive shall be granted, and the registrant may then sell, offer for sale, or introduce into commerce the registered product as permitted by §79.4. (iv) Once the new product becomes registered, EPA reserves the right to require additional Tier 3 testing pursuant to the procedures specified in §79.54. (e) Inspection of a testing facility. (1) A testing facility, whether engaged in emissions analysis or health and/or welfare effects testing under the regulations in this subpart, shall permit an authorized employee or duly designated representative of EPA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this subpart applies. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except the EPA may seek production of these records in litigation or informal hearings. (2) EPA will not consider reliable for purposes of showing that a test substance does or does not present a risk of injury to health or the environment any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this section. The determination that a study will not be considered reliable does not, however, relieve the sponsor of a required test of any obligation under any applicable statute or regulation to submit the results of the study to EPA. (3) Effects of non-compliance. Pursuant to sections 114, 208, and 211(d) of the CAA, it shall be a violation of this section and a violation of 40 CFR part 79, subpart F to deny entry to an authorized employee or duly designated representative of EPA for the purpose of auditing a testing facility or test data. (f) Penalties and Injunctive Relief. (1) Any person who violates these regulations shall be subject to a civil penalty of up to $25,000 for each and every day of the continuance of the violation and the economic benefit or savings resulting from the violation. Action to collect such civil penalties shall be commenced in accordance with paragraph (b) of section 205 of the Clean Air Act or assessed in accordance with paragraph (c) of section 205 of the Clean Air Act, 42 U.S.C. 7524 (b) and (c). (2) Under section 205(b) of the CAA, the Administrator may commence a civil action for violation of this subpart in the district court of the United States for the district in which the violation is alleged to have occurred or in which the defendant resides or has a principal place of business. (3) Under section 205(c) of the CAA, the Administrator may assess a civil penalty of $25,000 for each and every day of the continuance of the violation and the economic benefit or savings resulting from the violation, except that the maximum penalty assessment shall not exceed $200,000, unless the Administrator and the Attorney General jointly determine that a matter involving a larger penalty amount is appropriate for administrative penalty assessment. Any such determination by the Administrator and the Attorney General shall not be subject to judicial review. (4) The Administrator may, upon application by the person against whom any such penalty has been assessed, remit or mitigate, with or without conditions, any such penalty. (5) The district courts of the United States shall have jurisdiction to compel the furnishing of information and the conduct of tests required by the Administrator under these regulations and to award other appropriate relief. Actions to compel such actions shall be brought by and in the name of the United States. In any such action, subpoenas for witnesses who are required to attend a district court in any district may run into any other district. (6) Cancellation. (i) The Administrator of EPA may issue a notice of intent to cancel a fuel or fuel additive registration if the Administrator determines that the registrant has failed to submit in a timely manner any data required to maintain registration under this part or under section 211(b) or 211(e) of the Clean Air Act. (ii) Upon issuance of a notice of intent to cancel, EPA will forward a copy of the notice to the registrant by certified mail, return receipt requested, at the address of record given in the registration, along with an explanation of the reasons for the proposed cancellation. (iii) The registrant will be afforded 60 days from the date of receipt of the notice of intent to cancel to submit written comments concerning the notice, and to demonstrate or achieve compliance with the specific data requirements which provide the basis for the proposed cancellation. If the registrant does not respond in writing within 60 days from the date of receipt of the notice of intent to cancel, the cancellation of the registration shall become final by operation of law and the Administrator shall notify the registrant of such cancellation. If the registrant responds in writing within 60 days from the date of receipt of the notice of intent to cancel, the Administrator shall review and consider all comments submitted by the registrant before taking final action concerning the proposed cancellation. The registrants' communications should be sent to the following address: Director, Field Operations and Support Division, 6406J—Fuel/Additives Registration, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460. (iv) As part of a written response to a notice of intent to cancel, a registrant may request an informal hearing concerning the notice. Any such request shall state with specificity the information the registrant wishes to present at such a hearing. If an informal hearing is requested, EPA shall schedule such a hearing within 60 days from the date of receipt of the request. If an informal hearing is held, the subject matter of the hearing shall be confined solely to whether or not the registrant has complied with the specific data requirements which provide the basis for the proposed cancellation. If an informal hearing is held, the designated presiding officer may be any EPA employee, the hearing procedures shall be informal, and the hearing shall not be subject to or governed by 40 CFR part 22 or by 5 U.S.C. 554, 556, or 557. A verbatim transcript of each informal hearing shall be kept and the Administrator shall consider all relevant evidence and arguments presented at the hearing in making a final decision concerning a proposed cancellation. (v) If a registrant who has received a notice of intent to cancel submits a timely written response, and the Administrator decides after reviewing the response and the transcript of any informal hearing to cancel the registration, the Administrator shall issue a final cancellation order, forward a copy of the cancellation order to the registrant by certified mail, and promptly publish the cancellation order in the (g) Modification of Regulation. (1) In special circumstances, a manufacturer subject to the registration requirements of this rule may petition the Administrator to modify the mandatory testing requirements in the test standard for any test required by this rule by application to Director, Field Operations and Support Division, at the address in paragraph (f)(6)(iii) of this section. (i) Such request shall be made as soon as the test sponsor is aware that the modification is necessary, but in no event shall the request be made after 30 days following the event which precipitated the request. (ii) Upon such request, the Administrator may, in circumstances which are outside the control of the manufacturer(s) or his/their agent and which could not have been reasonably foreseen or avoided, modify the mandatory testing requirements in the rule if such requirements are infeasible. (iii) If the Administrator determines that such modifications would not significantly alter the scope of the test, EPA will not ask for public comment before approving the modification. The Administrator will notify the test sponsor by certified mail of the response to the request. EPA will place copies of each application and EPA response in the public docket. EPA will publish a notice in the (iv) Where, in EPA's judgment, the requested modification of a test standard would significantly change the scope of the test, EPA will publish a notice in the (2) [Reserved] (h) Special Requirements for Additives. When an additive is the test subject, the following rules apply: (1) All required emission characterization and health effects testing procedures shall be performed on the mixture which results when the additive is combined with the base fuel for the appropriate fuel family (as specified in §79.55) at the maximum concentration recommended by the additive manufacturer pursuant to §79.21(d). This combination shall be known as the additive/base fuel mixture. (i) The appropriate fuel family to be utilized for the additive/base fuel mixture is the fuel family which contains the specific type(s) of fuel for which the additive is presently registered or for which the manufacturer of the additive is seeking registration. (ii) Additives belonging to more than one fuel family. (A) If an additive product is registered in two or more fuel families as of May 27, 1994, then the manufacturer of that additive is responsible for testing (or participating in group testing of) the respective additive/base fuel mixtures in compliance with the requirements of this subpart for each fuel family in which the manufacturer wishes to maintain a registration for its additive. (B) If a manufacturer is seeking to register such additive in two or more fuel families then, for testing and registration purposes, the additive shall be considered to be a member of each fuel family in which the manufacturer is seeking registration. The manufacturer is responsible for testing (or participating in group testing of) the respective additive/base fuel mixture in compliance with the requirements of this subpart for each fuel family in which the manufacturer wishes to obtain a product registration for its additive. (iii) In the case of the methanol fuel family, which contains two base fuels (M100 and M85 base fuels, pursuant to §79.55(d)), the applicable base fuel is the one which represents the fuel/additive group (specified in §79.56(e)(4)(i)(C)) containing fuels of which the most gallons are sold annually. (iv) Aftermarket additives which are intended by the manufacturer to be added to the fuel tank only at infrequent intervals shall be applied according to the manufacturer's specifications during mileage accumulation, pursuant to §79.57(c). However, during emission generation and testing, each tankful of fuel used must contain the fuel additive at its maximum recommended level. If the additive manufacturer believes that this maximum treatment rate will cause adverse effects to the test engine and/or that the engine's emissions may be subject to artifacts due to overuse of the additive, then the manufacturer may submit a request to EPA for modification of this requirement and related test procedures. Such request must include objective evidence that the modification(s) are needed, along with data demonstrating the maximum concentration of the additive which may actually reach the fuel tanks of vehicles in use. (v) Additives produced exclusively for use in #1 diesel fuel shall be tested in the diesel base fuel specified in §79.55(c), even though that base fuel is formulated with #2 diesel fuel. If a manufacturer is concerned that emissions generated from this combination of fuel and additive are subject to artifacts due to this blending, then that manufacturer may submit a request for a modification in test procedure requirements to the EPA. Any such request must include supporting test results and suggested test modifications. (vi) Bulk additives which are used intermittently for the direct purpose of conditioning or treating a fuel during storage or transport, or for treating or maintaining the storage, pipeline, and/or other components of the fuel distribution system itself and not the vehicle/engine for which the fuel is ultimately intended, shall, for purposes of this program, be added to the base fuel at the maximum concentration recommended by the additive manufacturer for treatment of the fuel or distribution system component. However, if the additive manufacturer believes that this treatment rate will cause adverse effects to the test engine and/or that the engine's emissions may be subject to artifacts due to overuse of the additive, then the manufacturer may submit a request to EPA for modification of this requirement and related test procedures. Such request must include objective evidence that the modification(s) are needed, along with data demonstrating the maximum concentration of the additive which may actually reach the fuel tanks of vehicles in use. (2) EPA shall use emissions speciation and health effects data generated in the analysis of the applicable base fuel as control data for comparison with data generated for the additive/base fuel mixture. (i) The base fuel control data may be: (A) Generated internally as an experimental control in conjunction with testing done in compliance with registration requirements for a specific additive; or (B) Generated externally in the course of testing different additive(s) belonging to the same fuel family, or in the testing of a base fuel serving as representative of the baseline group for the respective fuel family pursuant to §79.56(e)(4)(i). (ii) Control data generated using test equipment (including vehicle model and/or engine, or Evaporative Emissions Generator specifications, as appropriate) and protocols identical or nearly identical to those used in emissions and health effects testing of the subject additive/base fuel mixture would be most relevant for comparison purposes. (iii) If an additive manufacturer chooses the same vehicle/engine to independently test the base fuel as an experimental control prior to testing the additive/base fuel mixture, then the test vehicle/engine shall undergo two mileage accumulation periods, pursuant to §79.57(c). The initial mileage accumulation period shall be performed using the base fuel alone. After base fuel testing, and prior to testing of the additive/base fuel mixture, a second mileage accumulation period shall be performed using the additive/base fuel mixture. The procedures outlined in this paragraph shall not preclude a manufacturer from testing a base fuel and the manufacturer's additive/base fuel mixture separately in identical, or nearly identical, vehicles/engines. (i) Multiple Test Potential for Non-Baseline Products. (1) When the composition information reported in the registration application or basic registration data for a gasoline or diesel product meets criteria for classification as a non-baseline product (pursuant to §79.56(e)(3)(i)(B) or §79.56(e)(3)(ii)(B)), then the manufacturer is responsible for testing (or participating in group testing) of a separate formulation for each reported oxygenating compound, specified class of oxygenating compounds, or other substance which defines a separate non-baseline fuel/additive group pursuant to §79.56(e)(4)(ii)(A) or (B). For each such substance, testing shall be performed on a mixture of the relevant substance in the appropriate base fuel, formulated according to the specifications for the corresponding group representatives in §79.56(e)(4)(ii). (2) When the composition information reported in the registration application or basic registration data for a non- baseline gasoline product contains a range of total oxygenate concentration-in-use which encompasses gasoline formulations with less than 1.5 weight percent oxygen as well as gasoline formulations with 1.5 weight percent oxygen or more, then the manufacturer is required to test (or participate in applicable group testing of) a baseline gasoline formulation as well as one or more non-baseline gasoline formulations as described in paragraph (h)(1) of this section. (3) When the composition information reported in the registration application or basic registration data for a non- baseline diesel product contains a range of total oxygenate concentration-in-use which encompasses diesel formulations with less than 1.0 weight percent oxygen as well as diesel formulations with 1.0 weight percent oxygen or more, then the manufacturer is required to test (or participate in applicable group testing) of a baseline diesel formulation as well as one or more non-baseline diesel formulations as described in paragraph (h)(1) of this section. (4) The presence in a particular oxygenating additive of small amounts of other unintended oxygenate compounds as byproducts of the manufacturing process of the given oxygenating additive does not affect the grouping of that additive and does not create multiple testing responsibilities for manufacturers who blend that additive into fuel. (j) Multiple Test Potential for Atypical Fuel Formulations. When the composition information reported in the registration application or basic registration data for a fuel product includes more than one atypical bulk additive product (pursuant to §79.56(e)(2)(iii)), and when these additives belong to different fuel/additive groups (pursuant to §79.56(e)(4)(iii)), then: (1) When such disparate additive products are for the same purpose-in-use and are not ordinarily used in the fuel simultaneously, the fuel manufacturer shall be responsible for testing (or participating in the group testing of) a separate formulation for each such additive product. Testing related to each additive product shall be performed on a mixture of the additive in the applicable base fuel, as described in paragraph (g)(1) of this section, or by participation in the costs of testing the designated representative of the fuel/additive group to which each separate atypical additive product belongs. (2) When the disparate additive products are not for the same purpose-in-use, the fuel manufacturer shall nevertheless be responsible for testing a separate formulation for each such additive product, as described in paragraph (g)(1) of this section, if these additives are not ordinarily blended together in the same commercial formulation of the fuel. (3) When the disparate additive products are ordinarily blended together in the same commercial formulation of the fuel, then the fuel manufacturer shall be responsible for the testing of a single test formulation containing all such simultaneously used atypical additive products. Alternatively, this responsibility can be satisfied by enrolling such fuel product in a group which includes other fuel or additive products with the same total combination of atypical elements as that occurring in the fuel product in question. If the basic registration data for the subject fuel includes any alternative additives which contain atypical elements not represented in the test formulation, then the fuel manufacturer is also responsible for testing a separate formulation for each such additional disparate additive product. (k) Emission Control System Testing. If any information submitted in accordance with this subpart or any other information available to EPA shows that a fuel or fuel additive may have a deleterious effect on the performance of any emission control system or device currently in use or which has been developed to a point where in a reasonable time it would be in general use were such effect avoided, EPA may, in its judgment, require testing to determine whether such effects in fact exist. Such testing will be required in accordance with such protocols and schedules as the Administrator shall reasonably require and shall be paid for by the fuel or fuel additive manufacturer. [59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996; 62 FR 12575, 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) The emissions to be characterized shall be generated, collected, and stored according to the processes described in §79.57. Characterization of combustion and evaporative emissions shall be performed separately on each emission sample collected during the applicable emission generation procedure. (ii) As provided in §79.57(d), if the emission generation vehicle/engine is ordinarily equipped with an emission aftertreatment device, then all requirements in this section for the characterization of combustion emissions must be completed both with and without the aftertreatment device in a functional state. The emissions shall be generated three times (on three different days) without a functional aftertreatment device and, if applicable, three times (on three different days) with a functional aftertreatment device, and each such time shall be analyzed according to the remaining provisions in this paragraph (b) of this section. (iii) Measurement of background emissions: It is required that ambient/dilution air be analyzed for levels of background chemical species present at the time of emissions sampling (for both combustion and evaporative emissions) and that sample values be corrected by substracting the concentrations contributed by the ambient/dilution air. Background chemical species measurement/analysis during the FTP is specified in §§86.109–94(c)(5) and 86.135–94 of this chapter. (iv) Concentrations of emission products shall be reported either in units of grams per mile (g/mi) or grams per brake-horsepower/hour (g/bhp-hr) (for chassis dynamometer and engine dynamometer test configurations, respectively), as well as in units of weight percent of measured total hydrocarbons. (v) Laboratory practice must be of high quality and must be consistent with state-of-the-art methods as presented in current environmental and analytical chemistry literature. Examples of analytical procedures which may be used in conducting the emission characterization/speciation requirements of this section can be found among the references in paragraph (b)(5) of this section. (2) Characterization of the combustion emissions shall include, for products in all fuel families (except when expressly noted in this section): (i) Determination of the concentration of the basic emissions as follows: total hydrocarbons, carbon monoxide, oxides of nitrogen, and particulates. Manufacturers are referred to the vehicle certification procedures in 40 CFR part 86, subparts B and D (§§86.101 through 86.145 and §§86.301 through 86.348) for guidance on the measurement of the basic emissions of interest to this subpart. (ii) Characterization of the vapor phase of combustion emissions, as follows: (A) Determination of the identity and concentration of individual species of hydrocarbon compounds containing 12 or fewer carbon atoms. Such characterization shall begin within 30 minutes after emission collection is completed. (B) Determination of the identity and concentration of individual species of aldehyde and ketone compounds containing eight or fewer carbon atoms. Characterization of these emissions captured in cartridges shall be performed within two weeks if the cartridge is stored at room temperature, and one month if the cartridge is stored at 0 °C or less. If the emissions are sampled using the impinger method, the sample must be stored in a capped sample vial at 0 °C or less and characterized within one week. (C) Determination of the identity and concentration of individual species of alcohol and ether compounds containing six or fewer carbon atoms, for those fuels and additive/base fuel mixtures which contain alcohol and/or ether compounds containing from one to six carbon atoms in the uncombusted state. For fuel and additive formulations containing alcohols or ethers with more than six carbon atoms in the uncombusted state, alcohol and ether species with that higher number of carbon atoms or less must be identified and measured in the emissions. Such characterization shall begin within four hours after emission collection is completed. (iii) Characterization of the semi-volatile and particulate phases of combustion emissions to identify and measure polycyclic aromatic compounds, as follows: (A) Analysis for polycyclic aromatic compounds shall not be conducted at or soon after the start of a recommended engine lubricant change interval. (B) Analysis for polycyclic aromatic hydrocarbons (PAHs) and nitrated polycyclic aromatic hydrocarbons (NPAHs), specified in paragraph (b)(2)(iii)(D) of this section, need not be done for any fuels and additives in the methane or propane fuel families, nor for fuels and additives in the atypical categories of any other fuel families, pursuant to the definitions of such families and categories in §79.56. (C) Analysis for poly-chlorinated dibenzodioxins and dibenzofurans (PCDD/PCDFs), specified in paragraph (b)(2)(iii)(E) of this section, is required only for fuels and additives which contain chlorine as an atypical element, pursuant to paragraph (b)(2)(iv) of this section, which requires all individual emission products containing atypical elements to be determined for atypical fuels and additives. However, manufacturers of baseline and nonbaseline fuels and fuel additives in all fuel families, except those in the methane and propane fuel families, are strongly encouraged to conduct these analyses on a voluntary basis. (D) The analytical method used to measure species of PAHs and NPAHs should be capable of detecting at least 1 ppm (equivalent to 0.001 microgram (µg) of compound per milligram of organic extract) of these compounds in the extractable organic matter. The concentration of each individual PAH or NPAH compound identified shall be reported in units of microgram per mile or nanograms per brake-horsepower/hour (for chassis dynamometer and engine dynamometer test configurations, respectively). Each compound which is present at 0.001 µg per mile (0.5 nanograms per brake-horsepower/hour) or more must be identified, measured, and reported. The following individual species shall be measured: (1) PAHs: (i) Benzo(a)anthracene; (ii) Benzo[b]fluoranthene; (iii) Benzo[k]fluoranthene; (iv) Benzo(a)pyrene; (v) Chrysene; (vi) Dibenzo[a,h]anthracene; and (vii) Indeno[1,2,3-c,d]pyrene. (2) NPAHs: (i) 7-Nitrobenzo[a]anthracene; (ii) 6-Nitrobenzo[a]pyrene; (iii) 6-Nitrochrysene; (iv) 2-Nitrofluorene; and (v) 1-Nitropyrene. (E) The analytical method used to measure species and classes of PCDD/PCDFs should be capable of detecting at least 1 part per trillion (ppt) (equivalent to 0.001 picogram (pg) of compound per milligram of organic extract) of these compounds in the extractable organic matter. The concentration of each individual PCDD/PCDF compound identified shall be reported in units of picograms (pg) per mile or picograms per brake-horsepower/hour (for chassis dynamometer and engine dynamometer test configurations, respectively). Each compound which is present at 0.5 pg/mile (0.3 pg/bhp-hr) or more must be identified, measured, and reported. (1) With respect to measurement of PCDD/PCDFs only, the liquid extracts from the particulate and semi-volatile emissions fractions may be combined into one sample for analysis. (2) The manufacturer is referred to 40 CFR part 60, appendix A, Method 23 for a protocol which may be used to identify and measure any potential PCDD/PCDFs which might be present in exhaust emissions from a fuel or additive/base fuel mixture. (3) The following individual compounds and classes of compounds of PCDD/PCDFs shall be identified and measured: (i) Individual tetra-chloro-substituted dibenzodioxins (tetra-CDDs); (ii) Individual tetra-chloro-substituted dibenzofurans (tetra-CDFs); (iii) Penta-CDDs and penta-CDFs, as one class; (iv) Hexa-CDDs and hexa-CDFs, as one class; (v) Hepta-CDDs and hepta-CDFs as one class; and (vi) Octo-CDDs and octo-CDFs as one class. (iv) With respect to all phases (vapor, semi-volatile, and particulate) of combustion emissions generated from those fuels and additive/base fuel mixtures classified in the atypical categories (pursuant to §79.56), the identity and concentration of individual emission products containing such atypical elements shall also be determined. (3) For evaporative fuels and evaporative fuel additives, characterization of the evaporative emissions shall include: (i) Determination of the concentration of total hydrocarbons for the applicable vehicle type and class in 40 CFR part 86, subpart B (§§86.101 through 86.145). (ii) Determination of the identity and concentration of individual species of hydrocarbon compounds containing 12 or fewer carbon atoms. Such characterization shall begin within 30 minutes after emission collection is completed. (iii) In the case of those fuels and additive/base fuel mixtures which contain alcohol and/or ether compounds in the uncombusted state, determination of the identity and concentration of individual species of alcohol and ether compounds containing six or fewer carbon atoms. For fuel and additive formulations containing alcohols or ethers with more than six carbon atoms in the uncombusted state, alcohol and ether species with that higher number of carbon atoms or less must be identified and measured in the emissions. Such characterization shall begin within four hours after emission collection is completed. (iv) In the case of those fuels and additive/base fuel mixtures which contain atypical elements, determination of the identity and concentration of individual emission products containing such atypical elements. (4) Laboratory quality control. (i) At a minimum, laboratories performing the procedures specified in this section shall conduct calibration testing of their emissions characterization equipment before each new fuel/additive product test start-up. Known samples representative of the compounds potentially to be found in emissions from the product to be characterized shall be used to calibrate such equipment. (ii) Laboratories performing the procedures specified in this section shall agree to permit quality control inspections by EPA, and for this purpose shall admit any EPA Enforcement Officer, upon proper presentation of credentials, to any facility where vehicles are conditioned or where emissions are generated, collected, stored, sampled, or characterized in meeting the requirements of this section. Such laboratory audits may include EPA distribution of “blind” samples for analysis by participating laboratories. (5) References. For additional background information on the emission characterization procedures outlined in this paragraph, the following references may be consulted: (i) “Advanced Emission Speciation Methodologies for the Auto/Oil Air Quality Improvement Program—I. Hydrocarbons and Ethers,” Auto Oil Air Quality Improvement Research Program, SP–920, 920320, SAE, February 1992. (ii) “Advanced Speciation Methodologies for the Auto/Oil Air Quality Improvement Research Program—II. Aldehydes, Ketones, and Alcohols,” Auto Oil Air Quality Improvement Research Program, SP–920, 920321, SAE, February 1992. (iii) ASTM D 5197–91, “Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology).” (iv) Johnson J. H., Bagley, S. T., Gratz, L. D., and Leddy, D. G., “A Review of Diesel Particulate Control Technology and Emissions Effects—1992 Horning Memorial Award Lecture,” SAE Technical Paper Series, SAE 940233, 1994. (v) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210–2218, 1983. (vi) Perez, J.M., Jabs, R.E., Leddy, D.G., eds. “Chemical Methods for the Measurement of Unregulated Diesel Emissions (CRC-APRAC Project No. CAPI–1–64), Coordinating Research Council, CRC Report No. 551, August, 1987. (vii) Schuetzle, D., “Analysis of Nitrated Polycyclic Aromatic Hydrocarbons in Diesel Particulates,” Analytical Chemistry, Volume 54, pp. 265–271, 1982. (viii) Siegl, W.O., et al., “Improved Emissions Speciation Methodology for Phase II of the Auto/Oil Air Quality Improvement Research Program—Hydrocarbons and Oxygenates”, SAE Technical Paper Series, SAE 930142, 1993. (ix) Tejada, S. B. et al., “Analysis of Nitroaromatics in Diesel and Gasoline Car Emissions,” SAE Paper No. 820775, 1982. (x) Tejada, S. B. et al., “Fluorescence Detection and Identification of Nitro Derivatives of Polynuclear Aromatic Hydrocarbons by On-Column Catalytic Reduction to Aromatic Amines,” Analytical Chemistry, Volume 58, pp. 1827–1834, July 1986. (xi) “Test Method for Determination of C1–C4 Alcohols and MTBE in Gasoline by Gas Chromatography,” 40 CFR part 80, appendix F. (c) [Reserved] (d) Literature Search. (1) Manufacturers of fuels and fuel additives shall conduct a literature search and compilation of information on the potential toxicologic, environmental, and other public welfare effects of the emissions of such fuels and additives. The literature search shall include all available relevant information from in-house, industry, government, and public sources pertaining to the emissions of the subject fuel or fuel additive or the emissions of similar fuels or additives, with such similarity determined according to the provisions of §79.56. (2) The literature search shall address the potential adverse effects of whole combustion emissions, evaporative emissions, relevant emission fractions, and individual emission products of the subject fuel or fuel additive except as specified in the following paragraph. The individual emission products to be included are those identified pursuant to the emission characterization procedures specified in paragraph (b) of this section, other than carbon monoxide, carbon dioxide, nitrogen oxides, benzene, 1,3-butadiene, acetaldehyde, and formaldehyde. (3) In the case of the individual emission products of non-baseline or atypical fuels and additives (pursuant to §79.56(e)(2)), the literature data need not be submitted for those emission products which are the same as the combustion emission products of the respective base fuel for the product's fuel family (pursuant to §79.55). For this purpose, data on the base fuel emission products for the product's fuel family: (i) May be found in the literature of previously-conducted, adequate emission speciation studies for the base fuel, or for a fuel or additive/fuel mixture capable of grouping with the base fuel (see, for example, the references in paragraph (b)(5) of this section). (ii) May be compiled while gathering internal control data during emissions characterization studies on the manufacturer's non-baseline or atypical product; or (iii) May be obtained from various manufacturers in the course of their testing different additive(s) belonging to the same fuel family, or in the testing of a base fuel serving as representative of the baseline group for the respective fuel family. (e) Data bases. The literature search must include the results of searching appropriate commercially available chemical, toxicologic, and environmental databases. The databases shall be searched using, at a minimum, CAS numbers (when applicable), chemical names, and common synonyms. (f) Search period. The literature search shall cover a time period beginning at least thirty years prior to the date of submission of the reports specified in §§79.59(b) through (c) and ending no earlier than six months prior to the date on which testing is commenced or reports are submitted in compliance with this subpart. (g) References. Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following: (1) Auto/Oil Air Quality Improvement Research Program, Technical Bulletin #1, December 1990. (2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210–2218, 1983. (3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373. [59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996; 62 FR 12571, Mar. 17, 1997] (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 done in accordance with the procedures, equipment, and facility requirements described in §§79.57, 79.60, and 79.61 regarding emissions generation, good laboratory practices, and inhalation exposure testing, respectively, as well as any other requirements described in this subpart. The laboratory conducting the animal studies shall be registered and in good standing with the United States Department of Agriculture and regularly inspected by United States Department of Agriculture veterinarians. In addition, the facility must be accredited by a generally recognized independent organization which sets laboratory animal care standards. Use of inadequate test protocols or substandard laboratory techniques in performing any testing required by this subpart may result in cancellation of all affected registrations. (2) Carcinogenic or mutagenic effects in animals from emissions exposures shall be determined pursuant to §79.64 In vivo Micronucleus Assay, §79.65 In vivo Sister Chromatid Exchange Assay, and §79.68 Salmonella typhimurium Reverse Mutation Assay. Teratogenic effects and reproductive toxicity shall be examined pursuant to §79.63 Fertility Assessment/Teratology. General toxicity and pulmonary effects shall be determined pursuant to §79.62 Subchronic Toxicity Study with Specific Health Effect Assessments. Neurotoxic effects shall be determined pursuant to §79.66 Neuropathology Assessment and §79.67 Glial Fibrillary Acidic Protein Assay. (d) EPA Determination. (1) After submission of all information and testing, EPA in its judgment shall determine whether previously conducted tests relied upon in the registration submission are adequately performed and documented and provide information reasonably comparable to that which would be provided by the tests described herein. Manufacturers' submissions shall be sufficiently detailed to allow EPA to judge the adequacy of protocols, techniques, experimental design, statistical analyses, and conclusions. Studies shall be performed using generally accepted scientific principles, good laboratory techniques, and the testing guidelines specified in these regulations. (2) EPA shall give appropriate weight when making this determination to the following factors: (i) The age of the data; (ii) The adequacy of documentation of procedures, findings, and conclusions; (iii) The extent to which the testing conforms to generally accepted scientific principles and practices; (iv) The type and number of test subjects; (v) The number and adequacy of exposure concentrations, i.e., emission dilutions; (vi) The degree to which the tested emissions were generated by procedures and under conditions reasonably comparable to those set forth in §79.57; and (vii) The degree to which the test procedures conform to the testing guidelines set forth in §§79.60 through 79.68 and/or furnish information comparable to that provided by such testing. (3) The test animals shall be rodents, preferably a strain of rat, and testing shall include all of the endpoints covered in §§79.62 through 79.68. All studies shall be properly executed, with appropriate documentation, and in accord with the individual health testing guidelines (§§79.60 through 79.68) of this part, e.g., 90-day, 6-hour per day exposure, minimum. (4) In general, the data in a manufacturer's registration submittal shall be adequate if the duration of a test's exposure period is at least as long, in days and hours, as the inhalation exposure specified in the related health test guideline(s). Data from tests with shorter exposure durations than those specified in the guidelines may be acceptable if the test results are positive (i.e., exhibit adverse effects) and/or include a demonstrable concentration-response relationship. (5) Data in support of a manufacturer's registration submittal shall directly address the effects of inhalation exposure to the whole evaporative and exhaust emissions of the respective fuel or additive or to the whole evaporative and exhaust emissions of other fuels or additives which satisfy the criteria in §79.56 for classification into the same group as the subject fuel or fuel additive. Data obtained in the testing of a raw liquid fuel or additive/base fuel mixture or a raw, aerosolized fuel or additive/base fuel mixture shall not be adequate to support a manufacturer's registration submittal. Data from testing of evaporative emissions cannot substitute for test data on combustion emissions. Data from testing of combustion emissions cannot substitute for test data on evaporative emissions. (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) in determining whether to require Tier 3 testing. EPA may consider, but is not limited to, the following factors: (i) Types and emission rates of speciated emission components; (ii) Types and emission rates of combinations of compounds or elements of concern; (iii) Historical and/or projected production volumes and market distributions; and (iv) Estimated population and/or environmental exposures obtained through extrapolation, modeling, or literature search findings on ambient, occupational, or epidemiological exposures. (b) Notice. (1) EPA will determine whether Tier 3 testing is necessary upon receipt of a manufacturer's (or group's) submittal as prescribed under §79.51(d). If EPA determines on the basis of the Tier 1 and 2 data submission and any other available information that further testing is necessary, EPA will require the responsible manufacturer(s) to conduct testing as described elsewhere in this section. EPA will notify the manufacturer (or group) by certified letter of the purpose and nature of any proposed testing and of the proposed deadline for completing the testing. A copy of the letter will be placed in the public record. EPA will provide the manufacturer a 60-day comment period after the manufacturer's receipt of such notice. EPA may extend the comment period if it appears from the nature of the issues raised that further discussion is warranted. In the event that no comment is received by EPA from the manufacturer (or group) within the comment period, the manufacturer (or group) shall be deemed to have consented to the adoption by EPA of the proposed Tier 3 requirements. (2) EPA will issue a notice in the (3) EPA will include in the public record a copy of any timely comments concerning the proposed Tier 3 testing requirements received from the affected manufacturer or group or from the public, and the responses of EPA to such comments. After reviewing all such comments received, EPA will adopt final Tier 3 requirements by sending a certified letter describing such final requirements to the manufacturer or group. EPA will also issue a notice in the (4) Prior to beginning any required Tier 3 testing, the manufacturer shall submit detailed test protocols to EPA for approval. Once EPA has determined the Tier 3 testing requirements and approves the test protocols, any modification to the requirements shall be governed by §79.51(f). (c) Carcinogenicity and Mutagenicity Testing. (1) A potential need for Tier 3 carcinogenicity and/or mutagenicity testing may be indicated if the results of the In vivo Micronucleus Assay, required under §79.64, the In vivo Sister Chromatid Exchange Assay, required under §79.65, the Salmonella mutagenicity assay required under §79.68, or relevant pathologic findings under §79.62 demonstrate a statistically significant dose-related positive response as compared with appropriate controls. Alternatively, Tier 3 carcinogenicity testing and/or mutagenicity testing may be required if there are positive outcomes for at least one concentration in two or more of the tests required under §§79.64, 79.65, and 79.68. (2) The testing for carcinogenicity required under this paragraph may, at EPA's discretion, be conducted in accordance with 40 CFR 798.3300 or 798.3320, or their equivalents (see suggested references following each health effects testing guideline). The testing for mutagenicity required under this paragraph may likewise be conducted in accordance with 40 CFR 798.5195, 798.5500, 798.5955, 798.7100, and/or other suitable equivalent testing (see suggested references following each health effects testing guideline). EPA may supplement or modify guidelines as required to ensure that the prescribed testing addresses the identified areas of concern. (d) Reproductive and Teratological Effects Testing. (1) A potential need for Tier 3 testing may be indicated if the results of the Fertility Assessment/Teratology study required under §79.63 or relevant findings under §79.62 demonstrate, in comparison with appropriate controls, a statistically significant dose-related positive response in one or more of the possible test outcomes. Similarly, Tier 3 testing may be indicated if statistically significant positive results are confined to either sex, or to the fetus as opposed to the pregnant adult. (2) The testing for reproductive and teratological effects required under this paragraph may, at EPA's discretion, be conducted in accordance with 40 CFR 798.4700 and/or by performance of a reproductive assay by continuous breeding. These guidelines may be modified or supplemented by EPA as required to ensure that the prescribed testing addresses the identified areas of concern. (e) Neurotoxicity Testing. (1) A potential need for Tier 3 neurotoxicity testing may be indicated if either the results of the Neuropathology Assessment required under §79.67 shows concentration-related effects in exposed animals or the Glial Fibrillary Acidic Protein Assay required under §79.66 demonstrates a statistically significant concentration-related positive response as compared with appropriate controls. Similarly, Tier 3 neurotoxicity testing may be indicated if relevant results under §79.62 demonstrate a statistically significant positive response in comparison to appropriate controls. (2) The testing for neurotoxicity required under this paragraph may, at EPA's discretion, be conducted in accordance with 40 CFR 798.3260 and 40 CFR part 798 subpart G. These guidelines may be modified or supplemented by EPA as required to ensure that the prescribed testing addresses the identified areas of concern. (f) General and Pulmonary Toxicity Testing. (1) A potential need for Tier 3 general and/or pulmonary toxicity testing may be indicated if, in comparison with appropriate controls, the results of the Subchronic Toxicity Study, pursuant to §79.62, demonstrate abnormal gross analysis or histopathological findings (especially as relates to lung pathology from whole-body preserved test animals) or persistence or delayed occurrence of toxic effects beyond the exposure period. (2) A potential need for Tier 3 testing with respect to other organ systems or endpoints not addressed by specific Tier 2 tests, e.g., hepatic, renal, or endocrine toxicity, may be demonstrated by findings in the Tier 2 Subchronic Toxicity Study (pursuant to §79.62) or by findings in the Tier 1 literature search of adverse functional, physiologic, metabolic, or histopathologic effects of fuel or additive emissions to such other organ systems or any other information available to EPA. In addition, findings in the Tier 1 emission characterization of significant levels of a known toxicant to such other organ systems and endpoints may also indicate a need for relevant health effects testing. The testing required under this paragraph may include tests conducted in accordance with 40 CFR 798.3260 or 798.3320. These guidelines may be modified or supplemented by EPA as necessary to ensure that the prescribed testing addresses the identified areas of concern. (3) The testing for general/pulmonary toxicity required under this paragraph may, at EPA's discretion, be conducted in accordance with 40 CFR 798.2450 or 798.3260. These guidelines may be modified or supplemented by EPA as necessary to ensure that the prescribed testing addresses the identified areas of concern. Pulmonary function measurements, host defense assays, immunotoxicity tests, cell morphology/morphometry, and/or enzyme assays of lung lavage cells and fluids may be specifically required. (g) Other Tier 3 Testing. (1) A manufacturer or group may be required to use up-to-date modeling, sampling, monitoring, and/or analytic approaches at the Tier 3 level to provide: (i) Estimates of exposures to the emission products of a fuel or fuel additive or group of products; (ii) The expected atmospheric transformation products of such emissions; and (iii) The environmental partitioning of such emissions to the air, soil, water, and biota. (2) Additional emission characterization may be required if uncertainty over the identity of chemical species or rate of their emission interferes with reasonable judgments as to the presence and/or concentration of potentially toxic substances in the emissions of a fuel or fuel additive. The required tests may include characterization of additional classes of emissions, the characterization of emissions generated by additional vehicles/engines of various technology mixes (e.g., catalyzed versus non-catalyzed emissions), and/or other more precise analytic procedures for identification or quantification of emissions compounds. Additional emissions testing may also be required to evaluate concerns which may arise regarding the potential effects of a fuel or fuel additive on the performance of emission control equipment. (3) A manufacturer or group may be required to conduct biological and/or exposure studies at the Tier 3 level to evaluate directly the potential public welfare or environmental effects of the emissions of a fuel or additive, if significant concerns about such effects arise as a result of EPA's review of the literature search or emission characterization findings in Tier 1 or the results of the toxicological tests in Tier 2. (4) With regard to group submittals, Tier 3 studies on a fuel or additive product(s) other than the originally specified group representative may be required if specific differences in the product's composition indicate that its emissions may have different toxicologic properties from those of the original group representative. (5) Additional emission characterization and/or toxicologic tests may be required to evaluate the impact of different vehicle, engine, or emission control technologies on the observed composition or health or welfare effects of the emissions of a fuel or additive. (6) Toxicological tests on individual emission products may be required. (7) Upon review of information submitted for an aerosol product under §79.58(e), emissions characterization, exposure, and/or toxicologic testing at a Tier 3 level may be required. (8) A manufacturer which qualifies for and has elected to use the special provisions for the products of small businesses (pursuant to §79.58(d)) may be required to conduct emission characterization, exposure, and/or toxicologic studies at the Tier 3 level for such products, as specified in §79.58(d)(4). (9) The examples of potential Tier 3 tests described in this section do not in any way limit EPA's broad discretion and authority under Tier 3. (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 respe
Title 40: Protection of Environment
PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES
Section Contents
§ 79.1 Applicability.
§ 79.2 Definitions.
§ 79.3 Availability of information.
§ 79.4 Requirement of registration.
§ 79.5 Periodic reporting requirements.
§ 79.6 Requirement for testing.
§ 79.7 Samples for test purposes.
§ 79.8 Penalties.
§ 79.10 Application for registration by fuel manufacturer.
§ 79.11 Information and assurances to be provided by the fuel manufacturer.
§ 79.12 Determination of noncompliance.
§ 79.13 Registration.
§ 79.14 Termination of registration of fuels.
§ 79.20 Application for registration by additive manufacturer.
§ 79.21 Information and assurances to be provided by the additive manufacturer.
§ 79.22 Determination of noncompliance.
§ 79.23 Registration.
§ 79.24 Termination of registration of additives.
§ 79.30 Scope.
§ 79.31 Additives.
§ 79.32 Motor vehicle gasoline.
§ 79.33 Motor vehicle diesel fuel.
§ 79.50 Definitions.
§ 79.51 General requirements and provisions.
§ 79.52 Tier 1.
§ 79.53 Tier 2.
§ 79.54 Tier 3.
§ 79.55 Base fuel specifications.
§ 79.56 Fuel and fuel additive grouping system.
§ 79.57 Emission generation.
§ 79.58 Special provisions.
§ 79.59 Reporting requirements.
§ 79.60 Good laboratory practices (GLP) standards for inhalation exposure health effects testing.
§ 79.61 Vehicle emissions inhalation exposure guideline.
§ 79.62 Subchronic toxicity study with specific health effect assessments.
§ 79.63 Fertility assessment/teratology.
§ 79.64
§ 79.65
§ 79.66 Neuropathology assessment.
§ 79.67 Glial fibrillary acidic protein assay.
§ 79.68
Subpart A—General Provisions
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§ 79.1 Applicability.
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§ 79.2 Definitions.
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§ 79.3 Availability of information.
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§ 79.4 Requirement of registration.
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§ 79.5 Periodic reporting requirements.
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§ 79.6 Requirement for testing.
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§ 79.7 Samples for test purposes.
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§ 79.8 Penalties.
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Subpart B—Fuel Registration Procedures
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§ 79.10 Application for registration by fuel manufacturer.
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§ 79.11 Information and assurances to be provided by the fuel manufacturer.
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§ 79.12 Determination of noncompliance.
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§ 79.13 Registration.
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§ 79.14 Termination of registration of fuels.
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Subpart C—Additive Registration Procedures
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§ 79.20 Application for registration by additive manufacturer.
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§ 79.21 Information and assurances to be provided by the additive manufacturer.
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§ 79.22 Determination of noncompliance.
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§ 79.23 Registration.
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§ 79.24 Termination of registration of additives.
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Subpart D—Designation of Fuels and Additives
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§ 79.30 Scope.
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§ 79.31 Additives.
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§ 79.32 Motor vehicle gasoline.
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§ 79.33 Motor vehicle diesel fuel.
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Subpart E [Reserved]
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Subpart F—Testing Requirements for Registration
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§ 79.50 Definitions.
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§ 79.51 General requirements and provisions.
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§ 79.52 Tier 1.
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§ 79.53 Tier 2.
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§ 79.54 Tier 3.
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§ 79.55 Base fuel specifications.
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