Title 40—Protection of Environment--Volume 1
PART 79—REGISTRATION OF FUELS AND FUEL ADDITIVES
§ 79.1   Applicability.
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).
§ 79.2   Definitions.
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.
§ 79.3   Availability of information.
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.
§ 79.4   Requirement of registration.
(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.
§ 79.5   Periodic reporting requirements.
(a) Fuel manufacturers. (1) For each calendar year (January 1 through December 31) commencing after the date prescribed for any fuel in subpart D of this part, fuel manufacturers must submit to the Administrator a report for each registered fuel showing the range of concentration of each additive reported under § 79.11(a) and the volume of such fuel produced in the year. Reports must be submitted by March 31 for the preceding year, or part thereof, on forms supplied by the Administrator. If the date prescribed for a particular fuel in subpart D of this part, or the later registration of a fuel is between October 1 and December 31, no report will be required for the period to the end of that year.
Table 1 to § 79.5—Quarterly Reporting Deadlines
(2) Fuel manufacturers shall submit to the Administrator a report annually for each registered fuel providing additional data and information as specified in §§ 79.32(c) and (d) and 79.33(c) and (d) in the designation of the fuel in subpart D of this part. Reports shall be submitted by March 31 for the preceding year, or part thereof, on forms supplied by the Administrator upon request. If the date prescribed for a particular fuel in subpart D of this part, or the later registration of a fuel is between October 1 and December 31, no report will be required for the period to the end of that year.
(b) Additive manufacturers. Additive manufacturers shall submit to the Administrator a report annually for each registered additive providing additional data and information as specified in § 79.31(c) and (d) in the designation of the additive in subpart D of this part. Additive manufacturers shall also report annually the volume of each additive produced. Reports shall be submitted by March 31 for the preceding year, or part thereof, on forms supplied by the Administrator upon request. If the date prescribed for a particular additive in subpart D of this part, or the later registration of an additive is between October 1 and December 31, no report will be required for the 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.
§ 79.6   Requirement for testing.
Provisions regarding testing that is required for registration of a designated fuel or fuel additive are contained in subpart F of this part.
§ 79.7   Samples for test purposes.
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.
§ 79.8   Penalties.
Any person who violates section 211(a) of the Act or who fails to furnish any information or conduct any tests required under this part shall be liable to the United States for a civil penalty of not more than the sum of $25,000 for every day of such violation and the amount of economic benefit or savings resulting from the violation. Civil penalties shall be assessed in accordance with paragraphs (b) and (c) of section 205 of the Act. The civil monetary penalty amount listed in this section may not reflect recent inflation adjustments EPA is required to make. The current maximum and minimum statutory civil penalty amounts are located in § 19.4.
§ 79.10   Application for registration by fuel manufacturer.
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.
§ 79.11   Information and assurances to be provided by the fuel manufacturer.
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.
§ 79.12   Determination of noncompliance.
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.
§ 79.13   Registration.
(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.
§ 79.14   Termination of registration of fuels.
Registration may be terminated by the Administrator if the fuel manufacturer requests such termination in writing.
§ 79.20   Application for registration by additive manufacturer.
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.
§ 79.21   Information and assurances to be provided by the additive manufacturer.
Each application for registration submitted by the manufacturer of a designated fuel additive shall include the following:
(a) The chemical composition of the additive with the methods of analysis identified, except that
(1) If the chemical composition is not known, full disclosure of the chemical process of manufacture will be accepted in lieu thereof;
(2) In the case of an additive for engine oil, only the name, percentage by weight, and method of analysis of each element in the additive are required provided, however, that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided unless the breakdown into percentages for these individual elements is already known to the registrant.
(3) In the case of a purchased component, only the name, manufacturer, and percent by weight of such purchased component are required if the manufacturer of the component will, upon request, furnish the Administrator with the chemical composition thereof.
(b) The chemical structure of each compound in the additive if such structure is known and is not adequately specified by the name given under “chemical composition.” Nominal identification is adequate if mixed isomers are present.
(c) The description (or identification, in the case of a generally accepted method) of a suitable analytical technique (if one is known) that can be used to detect the presence of the additive in any fuel named in the designation and/or to measure its concentration therein.
(d) The specific types of fuels designated under § 79.32 for which the fuel additive will be sold, offered for sale, or introduced into commerce, and the fuel additive manufacturer's recommended range of concentration and purpose-in-use for each such type of fuel.
(e) Such other data and information as are specified in the designation of the additive in subpart D.
(f) Assurances that any change in information submitted pursuant to:
(1) Paragraphs (a), (b), (c), (d), and (j) of this section will be provided to the Administrator in writing within 30 days of such change; and
(2) Paragraph (e) of this section as provided in § 79.5(b).
(g)(1) 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, except as specified in paragraph (g)(2) of this section.
(2) In the case of an additive that has its purpose-in-use identified as a deposit control additive for use in gasoline pursuant to the requirements of paragraph (d) of this section, the additive manufacturer may publicly represent that the additive meets the EPA's gasoline deposit control requirements, provided that the additive manufacturer is in compliance with the requirements of 40 CFR 1090.260.
(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.
(j) If the purpose-in-use of the additive identified pursuant to the requirements of paragraph (d) of this section is a deposit control additive for use in gasoline, the manufacturer must submit the following in addition to the other information specified in this section:
(1) The lowest additive concentration (LAC) that is compliant with the gasoline deposit control requirements of 40 CFR 1090.260.
(2) The deposit control test method in 40 CFR 1090.1395 that the additive is compliant with.
(3) A complete listing of the additive's components and the weight or volume percent (as applicable) of each component.
(i) Nomenclature. When possible, standard chemical nomenclature must be used or the chemical structure of the component must be given. Polymeric components may be reported as the product of other chemical reactants, provided that the supporting data specified in paragraph (j)(3) of this section is also reported.
(ii) Designation. Each detergent-active component of the package must be classified into one of the following designations:
(A) Polyalkyl amine.
(B) Polyether amine.
(C) Polyalkylsuccinimide.
(D) Polyalkylaminophenol.
(E) Detergent-active petroleum-based carrier oil.
(F) Detergent-active synthetic carrier oil.
(G) Other detergent-active component (identify category, if feasible).
(iii) Composition variability. (A) The composition of a detergent additive reported in a single additive registration (and the detergent additive product sold under a single additive registration) may not include the following:
( 1 ) Detergent-active components that differ in identity from those contained in the detergent additive package at the time of deposit control testing.
( 2 ) A range of concentrations for any detergent-active component such that, if the component were present in the detergent additive package at the lower bound of the reported range, the deposit control effectiveness of the additive package would be reduced as compared with the level of effectiveness demonstrated pursuant to the requirements of 40 CFR 1090.260. Subject to the foregoing constraint, a gasoline detergent additive sold under a particular additive registration may contain a higher concentration of the detergent-active component(s) than the concentration(s) of such component(s) reported in the registration for the additive.
(B) The identity or concentration of non-detergent-active components of the detergent additive package may vary under a single registration provided that such variability does not reduce the deposit control effectiveness of the additive package as compared with the level of effectiveness demonstrated pursuant to the requirements of 40 CFR 1090.260.
(C) Unless the additive manufacturer provides EPA with data to substantiate that a carrier oil does not act to enhance the detergent additive's ability to control deposits, any carrier oil contained in the detergent additive, whether petroleum-based or synthetic, must be treated as a detergent-active component in accordance with the requirements in paragraph (j)(3)(ii) of this section.
(D) Except as provided in paragraph (j)(3)(iii)(E) of this section, detergent additive packages that do not satisfy the requirements in paragraphs (j)(3)(iii)(A) through (C) must be separately registered. EPA may disqualify an additive for use in satisfying the requirements of this subpart if EPA determines that the variability included within a given detergent additive registration may reduce the deposit control effectiveness of the detergent package such that it may invalidate the lowest additive concentration reported in accordance with the requirements of paragraph (j)(1) of this section and 40 CFR 1090.260.
(E) A change in minimum concentration requirements resulting from a modification of detergent additive composition does not require a new detergent additive registration or a change in existing registration if the modification is affected by a detergent blender pursuant to the requirements of 40 CFR 1090.1240.
(4) For detergent-active polymers and detergent-active carrier oils that are reported as the product of other chemical reactants:
(i) Identification of the reactant materials and the manufacturer's acceptance criteria for determining that these materials are suitable for use in synthesizing detergent components. The manufacturer must maintain documentation, and submit it to EPA upon request, demonstrating that the acceptance criteria reported to EPA are the same criteria which the manufacturer specifies to the suppliers of the reactant materials.
(ii) A Gel Permeation Chromatograph (GPC), providing the molecular weight distribution of the polymer or detergent-active carrier oil components and the concentration of each chromatographic peak representing more than one percent of the total mass. For these results to be acceptable, the GPC test procedure must include equipment calibration with a polystyrene standard or other readily attainable and generally accepted calibration standard. The identity of the calibration standard must be provided, together with the GPC characterization of the standard.
(5) For non-detergent-active carrier oils, the following parameters:
(i) T10, T50, and T90 distillation points, and end boiling point, measured according to applicable test procedures cited in 40 CFR 1090.1350.
(ii) API gravity and viscosity.
(iii) Concentration of oxygen, sulfur, and nitrogen, if greater than or equal to 0.5 percent (by weight) of the carrier oil.
(6) Description of an FTIR-based method appropriate for identifying the detergent additive package and its detergent-active components (polymers, carrier oils, and others) both qualitatively and quantitatively, together with the actual infrared spectra of the detergent additive package and each detergent-active component obtained by this test method. The FTIR infrared spectra submitted in connection with the registration of a detergent additive package must reflect the results of a test conducted on a sample of the additive containing the detergent-active component(s) at a concentration no lower than the concentration(s) (or the lower bound of a range of concentration) reported in the registration pursuant to paragraph (j)(1) of this section.
(7) Specific physical parameters must be identified which the manufacturer considers adequate and appropriate, in combination with other information in this section, for identifying the detergent additive package and monitoring its production quality control.
(i) Such parameters must include (but need not be limited to) viscosity, density, and basic nitrogen content, unless the additive manufacturer specifically requests, and EPA approves, the substitution of other parameter(s) which the manufacturer considers to be more appropriate for a particular additive package. The request must be made in writing and must include an explanation of how the requested physical parameter(s) are helpful as indicator(s) of detergent production quality control. EPA will respond to such requests in writing; the additional parameters are not approved until the manufacturer receives EPA's written approval.
(ii) The manufacturer must identify a standardized measurement method, consistent with the chemical and physical nature of the detergent product, which will be used to measure each parameter. The documented ASTM repeatability for the method must also be cited. The manufacturer's target value for each parameter in the additive, and the expected range of production values for each parameter, must be specified.
(iii) The expected range of variability must differ from the target value by an amount no greater than five times the standard repeatability of the test procedure, or by no more than 10 percent of the target value, whichever is less. However, in the case of nitrogen analysis or other procedures for measuring concentrations of specific chemical compounds or elements, when the target value is less than 10 parts per million, a range of variability up to 50 percent of the target value will be considered acceptable.
(iv) If a manufacturer wishes to rely on measurement methods or production variability ranges which do not conform to the above limitations, then the manufacturer must receive prior written approval from EPA. A request for such allowance must be made in writing. It must fully justify the adequacy of the test procedure, explain why a broader range of variability is required, and provide evidence that the production detergent will perform adequately throughout the requested range of variability pursuant to the requirements of 40 CFR 1090.1395.
§ 79.22   Determination of noncompliance.
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.
§ 79.23   Registration.
(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.
§ 79.24   Termination of registration of additives.
(a) Registration may be terminated by the Administrator if the additive manufacturer requests such termination in writing.
(b) Registration for an additive that has its purpose-in-use identified as a deposit control additive for use in gasoline pursuant to the requirements of § 79.21(d) may be terminated by the Administrator if the EPA determines that the detergent additive is not compliant with the gasoline deposit control requirements of 40 CFR 1090.260.
§ 79.30   Scope.
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.
§ 79.31   Additives.
(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.
§ 79.32   Motor vehicle gasoline.
(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.”
(b) All designated motor vehicle gasolines must be registered by September 7, 1976.
(c) Fuel manufacturers must submit the reports specified in 40 CFR part 1090, subpart J.
(d) In accordance with §§ 79.5(a)(2) and 79.11(f), and to the extent such information is known to the fuel manufacturer, he shall furnish summaries of any information developed by or specifically for him concerning the following items:
(1) Mechanisms of action of each additive he reports;
(2) Reactions between such additives and motor vehicle gasoline;
(3) Identification and measurement of the emission products of such additives when used in motor vehicle gasoline;
(4) Effects of such additives on all emissions;
(5) Toxicity and any other public health or welfare effects of the emission products of such additives;
(6) Effects of the emission products of such additives on the performance of emission control devices/systems. Such submissions shall be accompanied by a description of the test procedures used in obtaining the information. Information will be considered to be known to the fuel manufacturer if a report thereon has been prepared and circulated or distributed outside the research department or division.
§ 79.33   Motor vehicle diesel fuel.
(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.
(b) All designated motor vehicle diesel fuels must be registered within 12 months after promulgation of this part.
(c) Fuel manufacturers must submit the reports specified in 40 CFR part 1090, subpart J.
(d) In accordance with §§ 79.5(a)(2) and 79.11(f), and to the extent such information is known to the fuel manufacturer, he shall furnish summaries of any information developed by or specifically for him concerning the following items:
(1) Mechanisms of action of each additive he reports;
(2) Reactions between such additives and motor vehicle diesel fuel;
(3) Identification and measurement of the emission products of such additives when used in motor vehicle diesel fuel;
(4) Effects of such additives on all emissions;
(5) Toxicity and any other public health or welfare effects of the emission products of such additives.
§ 79.50   Definitions.
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.
§ 79.51   General requirements and provisions.
(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: Attn: Fuel/Additives Registration, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Mail Code 6405A, 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 Federal Register. Any cancellation order issued after receipt of a timely written response by the registrant shall become legally effective five days after it is published in the Federal Register.
(7) The civil monetary penalty amounts listed in this section may not reflect recent inflation adjustments EPA is required to make. The current maximum and minimum statutory civil penalty amounts are located in § 19.4.
(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 Federal Register annually describing such changes which have occurred during the previous year. Until such Federal Register notice is published, any modification approved by EPA shall apply only to the person or group who requested the modification; EPA shall state the applicability of each modification in such notice.
(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 Federal Register requesting comment on the request and proposed modification. However, EPA may approve a requested modification of a test standard without first seeking public comment if necessary to preserve the validity of an ongoing test undertaken in good faith.
(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.
§ 79.52   Tier 1.
(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.
§ 79.53   Tier 2.
(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.
§ 79.54   Tier 3.
(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 Federal Register of its intent to require testing under Tier 3 for a particular fuel or additive manufacturer and that a copy of the letter to the manufacturer outlining the Tier 3 testing for that manufacturer is available in the public record for review and comment. The public shall have a minimum of thirty (30) days after the publication of this notice to comment on the proposed Tier 3 testing.
(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 Federal Register announcing that it has adopted such final Tier 3 requirements and that a copy of the letter adopting the requirements has been included in the public record.
(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.
§ 79.55   Base fuel specifications.
(a) General Characteristics. (1) The base fuel(s) in each fuel family shall serve as the group representative(s) for the baseline group(s) in each fuel family pursuant to § 79.56. Also, as specified in § 79.51(h)(1), for fuel additives undergoing testing, the designated base fuel for the respective fuel family shall serve as the substrate in which the additive shall be mixed prior to the generation of emissions.
(2) Base fuels shall contain a limited complement of the additives which are essential for the fuel's production or distribution and/or for the successful operation of the test vehicle/engine throughout the mileage accumulation and emission generation periods. Such additives shall be used at the minimum effective concentration-in-use for the base fuel in question.
(3) Unless otherwise restricted, the presence of trace contaminants does not preclude the use of a fuel or fuel additive as a component of a base fuel formulation.
(4) When an additive is the test subject, any additive normally contained in the base fuel which serves the same function as the subject additive shall be removed from the base fuel formulation. For example, if a corrosion inhibitor were the subject of testing and if this additive were to be tested in a base fuel which normally contained a corrosion inhibitor, this test additive would replace the corrosion inhibitor normally included as a component of the base fuel.
(5) Additive components of the methanol, ethanol, methane, and propane base fuels in addition to any such additives included below shall be limited to those recommended by the manufacturers of the vehicles and/or engines used in testing such fuels. For this purpose, EPA will review requests from manufacturers (or their agents) to modify the additive specifications for the alternative fuels and, if necessary, EPA shall change these specifications based on consistency of those changes with the associated vehicle manufacturer's recommendations for the operation of the vehicle. EPA shall publish notice of any such changes to a base fuel and/or its base additive package specifications in the Federal Register.
(b) Gasoline Base Fuel. (1) The gasoline base fuel is patterned after the reformulated gasoline summer baseline fuel as specified in CAA section 211(k)(10)(B)(i). The specifications and blending tolerances for the gasoline base fuel are listed in table F94-1. The additive types which shall be required and/or permissible in the gasoline base fuel are listed in table 1 as well.
Table F94-1—Gasoline Base Fuel Properties
(2) The additive components of the gasoline base fuel shall contain compounds comprised of no elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur. Additives shall be used at the minimum concentration needed to perform effectively in the gasoline base fuel. In no case shall their concentration in the base fuel exceed the maximum concentration recommended by the additive manufacturer. The increment of sulfur contributed to the formulation by any additive shall not exceed 15 parts per million sulfur by weight and shall not cause the gasoline base fuel to exceed the sulfur specifications in table F94-1 of this section.
(c) Diesel Base Fuel. (1) The diesel base fuel shall be a #2 diesel fuel having the properties and blending tolerances shown in table F94-2 of this section. The additive types which shall be permissible in diesel base fuel are presented in table F94-2 as well.
Table F94-2—Diesel Base Fuel Properties
(2) The additive components of the diesel base fuel shall contain compounds comprised of no elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur. Additives shall be used at the minimum concentration needed to perform effectively in the diesel base fuel. In no case shall their concentration in the base fuel exceed the maximum concentration recommended by the additive manufacturer. The increment of sulfur contributed to the base fuel by additives shall not cause the diesel base fuel to exceed the sulfur specifications in table F94-2 of this section.
(d) Methanol Base Fuels. (1) The methanol base fuels shall contain no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur, and chlorine.
(2) The M100 base fuel shall consist of 100 percent by volume chemical grade methanol.
(3) The M85 base fuel is to contain 85 percent by volume chemical grade methanol, blended with 15 percent by volume gasoline base fuel meeting the gasoline base fuel specifications outlined in paragraph (b)(1) of this section. Manufacturers shall ensure the methanol compatibility of lubricating oils as well as fuel additives used in the gasoline portion of the M85 base fuel.
(4) The methanol base fuels shall meet the specifications listed in table F94-3.
Table F94-3—Methanol Base Fuel Properties
(e) Ethanol Base Fuel. (1) The ethanol base fuel, E85, shall contain no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur, chlorine, and copper.
(2) The ethanol base fuel shall contain 85 percent by volume chemical grade ethanol, blended with 15 percent by volume gasoline base fuel that meets the specifications listed in paragraph (b)(1) of this section. Additives used in the gasoline component of E85 shall be ethanol-compatible.
(3) The ethanol base fuel shall meet the specifications listed in table F94-4.
Table F94-4—Ethanol Base Fuel Properties
(f) Methane Base Fuel. (1) The methane base fuel is a gaseous motor vehicle fuel marketed commercially as compressed natural gas (CNG), whose primary constituent is methane.
(2) The methane base fuel shall contain no elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur. The fuel shall contain an odorant additive for leak detection purposes. The added odorant shall be used at a level such that, at ambient conditions, the fuel must have a distinctive odor potent enough for its presence to be detected down to a concentration in air of not over 1/5 (one-fifth) of the lower limit of flammability. After addition of the odorant, the methane base fuel shall contain no more than 16 ppm sulfur by volume.
(3) The methane base fuel shall meet the specifications listed in table F94-5.
Table F94-5—Methane Base Fuel Specifications
(g) Propane Base Fuel. (1) The propane base fuel is a gaseous motor vehicle fuel, marketed commercially as liquified petroleum gas (LPG), whose primary constituent is propane.
(2) The propane base fuel may contain no elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur. The fuel shall contain an odorant additive for leak detection purposes. The added odorant shall be used at a level such that at ambient conditions the fuel must have a distinctive odor potent enough for its presence to be detected down to a concentration in air of not over 1/5 (one-fifth) of the lower limit of flammability. After addition of the odorant, the propane base fuel shall contain no more than 120 ppm sulfur by weight.
(3) The propane base fuel shall meet the specifications listed in table F94-6.
Table F94-6—Propane Base Fuel Specifications
§ 79.56   Fuel and fuel additive grouping system.
(a) Manufacturers of fuels and fuel additives are allowed to satisfy the testing requirements in §§ 79.52, 79.53, and 79.54 and the associated reporting requirements in § 79.59 on an individual or group basis, provided that such products meet the criteria in this section for enrollment in the same fuel/additive group. However, each manufacturer of a fuel or fuel additive must individually comply with the notification requirements of § 79.59(b). Further, if a manufacturer elects to comply by participation in a group, each manufacturer continues to be individually subject to the information requirements of this subpart.
(1) The use of the grouping provision to comply with Tier 1 and Tier 2 testing requirements is voluntary. No manufacturer is prohibited from testing and submitting its own data for its own product registration, despite its qualification for membership in a particular group.
(2) The only groups permitted are those established in this section.
(b) Each manufacturer who chooses to enroll a fuel or fuel additive in a group of similar fuels and fuel additives as designated in this section may satisfy the registration requirements through a group submission of jointly-sponsored testing and analysis conducted on a product which is representative of all products in that group, provided that the group representative is chosen according to the specifications in this section.
(1) The health effects information submitted by a group shall be considered applicable to all fuels and fuel additives in the group. A fuel or fuel additive manufacturer who has chosen to participate in a group may subsequently choose to perform testing of such fuel or fuel additive on an individual basis; however, until such independent registration information has been received and reviewed by EPA, the information initially submitted by the group on behalf of the manufacturer's fuel or fuel additive shall be considered applicable and valid for that fuel or fuel additive. It could therefore be used to support requirements for further testing under the provisions of Tier 3 or to support regulatory decisions affecting that fuel or fuel additive.
(2) Manufacturers are responsible for determining the appropriate groups for their products according to the criteria in this section and for enrolling their products into those groups under industry-sponsored or other independent brokering arrangements.
(3) Manufacturers who enroll a fuel or fuel additive into a group shall share the applicable costs according to appropriate arrangements established by the group. The organization and administration of group functions and the development of cost-sharing arrangements are the responsibility of the participating manufacturers. If manufacturers are unable to agree on fair and equitable cost sharing arrangements and if such dispute is referred by one or more manufacturers to EPA for resolution, then the provisions in § 79.56(c) (1) and (2) shall apply.
(c) In complying with the registration requirements for a given fuel or fuel additive, notwithstanding the enrollment of such fuel or additive in a group, a manufacturer may make use of available information for any product which conforms to the same grouping criteria as the given product. If, for this purpose, a manufacturer wishes to rely upon the information previously submitted by another manufacturer (or group of manufacturers) for registration of a similar product (or group of products), then the previous submitter is entitled to reimbursement by the manufacturer for an appropriate portion of the applicable costs incurred to obtain and report such information. Such entitlement shall remain in effect for a period of fifteen years following the date on which the original information was submitted. Pursuant to § 79.59(b)(4)(ii), the manufacturer who relies on previously-submitted registration data shall certify to EPA that the original submitter has been notified and that appropriate reimbursement arrangements have been made.
(1) When private efforts have failed to resolve a dispute about a fair amount or method of cost-sharing or reimbursement for testing costs incurred under this subpart, then any party involved in that dispute may initiate a hearing by filing two signed copies of a request for a hearing with a regional office of the American Arbitration Association and mailing a copy of the request to EPA. A copy must also be sent to each person from whom the filing party seeks reimbursement or who seeks reimbursement from that party. The information and fees to be included in the request for hearing are specified in 40 CFR 791.20(b) and (c).
(2) Additional procedures and requirements governing the hearing process are those specified in 40 CFR 791.22 through 791.50, 791.60, 791.85, and 791.105, excluding 40 CFR 791.39(a)(3) and 791.48(d).
(d) Basis for classification. (1) Rather than segregating fuels and fuel additives into separate groups, the grouping system applies the same grouping criteria and creates a single set of groups applicable both to fuels and fuel additives.
(2) Fuels shall be classified pursuant to § 79.56(e) into categories and groups of similar fuels and fuel additives according to the components and characteristics of such fuels in their uncombusted state. The classification of a fuel product must take into account the components of all bulk fuel additives which are listed in the registration application or basic registration data submitted for the fuel product.
(3) Fuel additives shall be classified pursuant to § 79.56(e) into categories and groups of similar fuels and fuel additives according to the components and characteristics of the respective uncombusted additive/base fuel mixture pursuant to § 79.51(h)(1).
(4) In determining the category and group to which a fuel or fuel additive belongs, impurities present in trace amounts shall be ignored unless otherwise noted. Impurities are those substances which are present through contamination or which remain in the fuel or additive naturally after processing is completed.
(5) Reference standards. (i) American Society for Testing and Materials (ASTM) standard D 4814-93a, “Standard Specification for Automotive Spark-Ignition Engine Fuel”, used to define the general characteristics of gasoline fuels (paragraph (e)(3)(i)(A)(3) of this section) and ASTM standard D 975-93, “Standard Specification for Diesel Fuel Oils”, used to define the general characteristics of diesel fuels (paragraph (e)(3)(ii)(A)(3) of this section) have been incorporated by reference.
(ii) This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103. Copies may be inspected at U.S. EPA, OAR, 401 M Street SW., Washington, DC 20460 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(e) Grouping criteria. The grouping system is represented by a matrix of three fuel/additive categories within six specified fuel families (see table F94-7, Grouping System for Fuels and Fuel Additives). Each category may include one or more groups. Within each group, a representative may be designated based on the criteria in this section and joint registration information may be developed and submitted for member fuels and fuel additives.
Table F94-7—Grouping System for Fuels and Fuel Additives
(1) Fuel families. Each of the following six fuel families (Table F94-7, columns A-F) includes fuels of the type referenced in the name of the family as well as bulk and aftermarket additives which are intended for use in those fuels. When applied to fuel additives, the criteria in these descriptions refer to the associated additive/base fuel mixture, pursuant to § 79.51(h)(1). One or more base fuel formulations are specified for each fuel family pursuant to § 79.55.
(i) The Gasoline Family includes fuels composed of more than 50 percent gasoline by volume and their associated fuel additives. The base fuel for this family is specified in § 79.55(b).
(ii) The Diesel Family includes fuels composed of more than 50 percent diesel fuel by volume and their associated fuel additives. The Diesel fuel family includes both Diesel #1 and Diesel #2 formulations. The base fuel for this family is specified in § 79.55(c).
(iii) The Methanol Family includes fuels composed of at least 50 percent methanol by volume and their associated fuel additives. The M100 and M85 base fuels are specified in § 79.55(d).
(iv) The Ethanol Family includes fuels composed of at least 50 percent ethanol by volume and their associated fuel additives. The base fuel for this family is E85 as specified in § 79.55(e).
(v) The Methane Family includes compressed natural gas (CNG) and liquefied natural gas (LNG) fuels containing at least 50 mole percent methane and their associated fuel additives. The base fuel for the family is a CNG formulation specified in § 79.55(f).
(vi) The Propane Family includes propane fuels containing at least 50 percent propane by volume and their associated fuel additives. The base fuel for this family is a liquefied petroleum gas (LPG) as specified in § 79.55(g).
(vii) A manufacturer seeking registration for formulation(s) which do not fit the criteria for inclusion in any of the fuel families described in this section shall contact EPA at the address in § 79.59(a)(1) for further guidance in classifying and testing such formulation(s).
(2) Fuel/additive categories. Fuel/additive categories (Table F94-7, rows 1-3) are subdivisions of fuel families which represent the degree to which fuels and fuel additives in the family resemble the base fuel(s) designated for the family. Three general category types are defined in this section. When applied to fuel additives, the criteria in these descriptions refer to the associated additive/base fuel mixture, pursuant to § 79.51(h)(1).
(i) Baseline categories consist of fuels and fuel additives which contain no elements other than those permitted in the base fuel for the respective fuel family and conform to specified limitations on the amounts of certain components or characteristics applicable to that fuel family.
(ii) Non-Baseline Categories consist of fuels and fuel additives which contain no elements other than those permitted in the base fuel for the respective fuel family, but which exceed one or more of the limitations for certain specified components or characteristics applicable to baseline formulations in that fuel family.
(iii) Atypical Categories consist of fuels and fuel additives which contain elements or classes of compounds other than those permitted in the base fuel for the respective fuel family or which otherwise do not meet the criteria for either baseline or non-baseline formulations in that fuel family. A fuel or fuel additive product having both non-baseline and atypical characteristics pursuant to § 79.56(e)(3), shall be considered to be an atypical product.
(3) This section defines the specific categories applicable to each fuel family. When applied to fuel additives, the criteria in these descriptions refer to the associated additive/base fuel mixture, pursuant to § 79.51(h)(1).
(i) Gasoline Categories. (A) The Baseline Gasoline category contains gasoline fuels and associated additives which satisfy all of the following criteria:
( 1 ) Contain no elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur.
( 2 ) Contain less than 1.5 percent oxygen by weight.
( 3 ) Sulfur concentration is limited to 1000 ppm per the specifications cited in the following paragraph.
( 4 ) Possess the physical and chemical characteristics of unleaded gasoline as specified by ASTM standard D 4814-93a (incorporated by reference, pursuant to paragraph (d)(5) of this section), in at least one Seasonal and Geographical Volatility Class.
( 5 ) Derived only from conventional petroleum, heavy oil deposits, coal, tar sands, and/or oil sands.
(B) The Non-Baseline Gasoline category is comprised of gasoline fuels and associated additives which conform to the specifications in paragraph (e)(3)(i)(A) of this section for the Baseline Gasoline category except that they contain 1.5 percent or more oxygen by weight and/or may be derived from sources other than those listed in paragraph (e)(3)(i)(A)( 5 ) of this section.
(C) The Atypical Gasoline category is comprised of gasoline fuels and associated additives which contain one or more elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur.
(ii) Diesel Categories. (A) The Baseline Diesel category is comprised of diesel fuels and associated additives which satisfy all of the following criteria:
( 1 ) Contain no elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur. Pursuant to 40 CFR 80.29, highway diesel sold after October 1, 1993 shall contain 0.05 percent or less sulfur by weight;
( 2 ) Contain less than 1.0 percent oxygen by weight;
( 3 ) Diesel formulations containing more than 0.05 percent sulfur by weight are precluded by 40 CFR 80.29;
( 4 ) Possess the characteristics of diesel fuel as specified by ASTM standard D 975-93 (incorporated by reference, pursuant to paragraph (d)(5) of this section); and
( 5 ) Derived only from conventional petroleum, heavy oil deposits, coal, tar sands, and/or oil sands.
(B) The Non-Baseline Diesel category is comprised of diesel fuels and associated additives which conform to the specifications in paragraph (e)(3)(ii)(A) of this section for the Baseline Diesel category except that they contain 1.0 percent or more oxygen by weight and/or may be derived from sources other than those listed in paragraph (e)(3)(ii)(A)( 5 ) of this section.
(C) The Atypical Diesel category is comprised of diesel fuels and associated additives which contain one or more elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur.
(iii) Methanol categories. (A) The Baseline Methanol category is comprised of methanol fuels and associated additives which contain at least 50 percent methanol by volume, no more than 4.0 percent by volume of substances other than methanol and gasoline, and no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur, and/or chlorine. Baseline methanol shall contain no more than 0.004 percent by weight of sulfur or 0.0001 percent by weight of chlorine.
(B) The Non-Baseline Methanol category is comprised of fuel blends which contain at least 50 percent methanol by volume, more than 4.0 percent by volume of a substance(s) other than methanol and gasoline, and meet the baseline limitations on elemental composition in paragraph (e)(3)(iii)(A) of this section.
(C) The Atypical Methanol category consists of methanol fuels and associated additives which do not meet the criteria for either the Baseline or the Non-Baseline Methanol category.
(iv) Ethanol categories. (A) The Baseline Ethanol category is comprised of ethanol fuels and associated additives which contain at least 50 percent ethanol by volume, no more than five (5) percent by volume of substances other than ethanol and gasoline, and no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur, chlorine, and copper. Baseline ethanol formulations shall contain no more than 0.004 percent by weight of sulfur, 0.0004 percent by weight of chlorine, and/or 0.07 mg/L of copper.
(B) The Non-Baseline Ethanol category is comprised of fuel blends which contain at least 50 percent ethanol by volume, more than five (5) percent by volume of a substance(s) other than ethanol and gasoline, and meet the baseline limitations on elemental composition in paragraph (e)(3)(iv)(A) of this section.
(C) The Atypical Ethanol category consists of ethanol fuels and associated additives which do not meet the criteria for either the Baseline or the Non-Baseline Ethanol categories.
(v) Methane categories. (A) The Baseline Methane category is comprised of methane fuels and associated additives (including at least an odorant additive) which contain no elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur, and contain no more than 20 mole percent non-methane hydrocarbons. Baseline methane formulations shall not contain more than 16 ppm by volume of sulfur, including any sulfur which may be contributed by the odorant additive.
(B) The Non-Baseline Methane category consists of methane fuels and associated additives which conform to the specifications in paragraph (e)(3)(v)(A) of this section for the Baseline Methane category except that they exceed 20 mole percent non-methane hydrocarbons.
(C) The Atypical Methane category consists of methane fuels and associated additives which contain one or more elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur, or exceed 16 ppm by volume of sulfur.
(vi) Propane categories. (A) The Baseline Propane category is comprised of propane fuels and associated additives (including at least an odorant additive) which contain no elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur, and contain no more than 20 percent by volume non-propane hydrocarbons. Baseline Propane formulations shall not contain more than 123 ppm by weight of sulfur, including any sulfur which may be contributed by the odorant additive.
(B) The Non-Baseline Propane category consists of propane fuels and associated additives which conform to the specifications in paragraph (e)(3)(vi)(A) of this section for the Baseline Propane category, except that they exceed the 20 percent by volume limit for butane and higher hydrocarbons.
(C) The Atypical Propane category consists of propane fuels and associated additives which contain elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur, or exceed 123 ppm by weight of sulfur.
(4) Fuel/additive groups. Fuel/additive groups are subdivisions of the fuel/additive categories. One or more group(s) are defined within each category in each fuel family according to the presence of differing characteristics in the fuel or additive/base fuel mixture. For each group, one formulation (either a base fuel or a member fuel or additive product) is chosen to represent all the member products in the group in any tests required under this subpart. The section which follows describes the fuel/additive groups.
(i) Baseline groups. (A) The Baseline Gasoline category comprises a single group. The gasoline base fuel specified in § 79.55(b) shall serve as the representative of this group.
(B) The Baseline Diesel category comprises a single group. The diesel base fuel specified in § 79.55(c) shall serve as the representative of this group.
(C) The Baseline Methanol category includes two groups: M100 and M85. The M100 group consists of methanol-gasoline formulations containing at least 96 percent methanol by volume. These formulations must contain odorants and bitterants (limited in elemental composition to carbon, hydrogen, oxygen, nitrogen, sulfur, and chlorine) for prevention of purposeful or inadvertent consumption. The M100 base fuel specified in § 79.55(d) shall serve as the representative for this group. The M85 group consists of methanol-gasoline formulations containing at least 50 percent by volume but less than 96 percent by volume methanol. The M85 base fuel specified in § 79.55(d) shall serve as the representative of this group.
(D) The Baseline Ethanol category comprises a single group. The E85 base fuel specified in § 79.55(e) shall serve as the representative of this group.
(E) The Baseline Methane category comprises a single group. The CNG base fuel specified in § 79.55(f) shall serve as the representative of this group.
(F) The Baseline Propane category comprises a single group. The LPG base fuel specified in § 79.55(g) shall serve as the representative of this group.
(ii) Non-baseline groups —(A) Non-Baseline Gasoline. The Non-Baseline gasoline fuels and associated additives shall sort into groups according to the following criteria:
( 1 ) For gasoline fuel and additive products which contain 1.5 percent oxygen by weight or more, a separate non-baseline gasoline group shall be defined by each oxygenate compound or methanol/co-solvent blend listed as a component in the registration application or basic registration data of any such fuel or additive.
( i ) Examples of oxygenates occurring in non-baseline gasoline formulations include ethanol, methyl tertiary butyl ether (MTBE), ethyl tertiary butyl ether (ETBE), tertiary amyl methyl ether (TAME), diisopropyl ether (DIPE), dimethyl ether (DME), tertiary amyl ethyl ether (TAEE), and any other compound(s) which increase the oxygen content of the gasoline formulation. A separate non-baseline gasoline group is defined for each such oxygenating compound.
( ii ) Each unique methanol and co-solvent combination (whether one, two, or more additional oxygenate compounds) used in a non-baseline fuel shall also define a separate group. An oxygenate compound used as a co-solvent for methanol in a non-baseline gasoline formulation must be identified as such in its registration. If the oxygenate is not identified as a methanol co-solvent, then the compound shall be regarded by EPA as defining a separate non-baseline gasoline group. Examples of methanol/co-solvent combinations occurring in non-baseline gasoline formulations include methanol/isopropyl alcohol, methanol/butanol, and methanol with alcohols up to C8/octanol (Octamix).
( iii ) For each such group, the representative to be used in testing shall be a formulation consisting of the gasoline base fuel blended with the relevant oxygenate compound (or methanol/co-solvent combination) in an amount equivalent to the highest actual or recommended concentration-in-use of the oxygenate (or methanol/co-solvent combination) recorded in the basic registration data of any member fuel or additive product. In the event that two or more products in the same group contain the same and highest amount of the oxygenate or methanol/co-solvent blend, then the representative shall be chosen at random for such candidate products.
( 2 ) An oxygenate compound or methanol/co-solvent combination to be blended with the gasoline base fuel for testing purposes shall be chemical-grade quality, at a minimum, and shall not contain a significant amount of other contaminating oxygenate compounds.
( 3 ) Separate non-baseline gasoline groups shall also be defined for gasoline formulations derived from each particular petroleum source not listed in paragraph (e)(3)(i)(A)( 5 ) of this section.
( i ) Such groups may include, but are not limited to, those derived from shale, used oil, waste plastics, and other recycled chemical/petrochemical products.
( 4 ) Pursuant to § 79.51(i), non-baseline gasoline products may belong to more than one fuel/additive group.
(B) Non-Baseline Diesel. The Non-Baseline diesel fuels and associated additives shall sort into groups according to the following criteria:
( 1 ) For diesel fuel and additive products which contain 1.0 percent or more oxygen by weight in the form of alcohol(s) and/or ether(s):
( i ) A separate non-baseline diesel group shall be defined by each individual alcohol or ether listed as a component in the registration application or basic registration data of any such fuel or additive.
( ii ) For each such group, the representative to be used in testing shall be a formulation consisting of the diesel base fuel blended with the relevant alcohol or ether in an amount equivalent to the highest actual or recommended concentration-in-use of the alcohol or ether recorded in the basic registration data of any member fuel or additive product.
( 2 ) A separate non-baseline diesel group is also defined for each of the following classes of oxygenating compounds: mixed nitroso-compounds; mixed nitro-compounds; mixed alkyl nitrates; mixed alkyl nitrites; peroxides; furans; mixed alkyl esters of plant and/or animal origin (biodiesel). For each such group, the representative to be used in testing shall be formulated as follows:
( i ) From the class of compounds which defines the group, a particular oxygenate compound shall be chosen from among all such compounds recorded in the registration application or basic registration data of any fuel or additive in the group.
( ii ) The selected compound shall be the one recorded in any member product's registration application with the highest actual or recommended maximum concentration-in-use.
( iii ) In the event that two or more oxygenate compounds in the relevant class have the highest recorded concentration-in-use, then the oxygenate compound to be used in the group representative shall be chosen at random from the qualifying candidate compounds.
( iv ) The compound thus selected shall be the group representative, and shall be used in testing at the following concentration:
( A ) For biodiesel groups, the representative shall be 100 percent biodiesel fuel.
( B ) Otherwise, the group representative shall be the selected compound mixed into diesel base fuel at the maximum recommended concentration-in-use.
( 3 ) Separate non-baseline diesel groups shall also be defined for diesel formulations derived from each particular petroleum source not listed in paragraph (e)(3)(i)(A)( 5 ) of this section.
( i ) Such groups may include, but are not limited to, those derived from shale, used oil, waste plastics, and other recycled chemical/petrochemical products.
( ii ) In any such group, the first product to be registered or to apply for EPA registration shall be the representative of that group. If two or more products are registered or apply for first registration simultaneously, then the representative shall be chosen by a random method from among such candidate products.
( 4 ) Pursuant to § 79.51(i), non-baseline diesel products may belong to more than one fuel/additive group.
(C) Non-baseline methanol. The Non-Baseline methanol formulations are sorted into groups based on the non-methanol, non-gasoline component(s) of the blended fuel. Each such component occurring separately and each unique combination of such components shall define a separate group.
( 1 ) The representative of each such non-baseline methanol group shall be the group member with the highest percent by volume of non-methanol, non-gasoline component(s).
( 2 ) In case two or more such members have the same and highest concentration of non-methanol, non-gasoline component(s), the representative of the group shall be chosen at random from among such equivalent member products.
(D) Non-Baseline Ethanol. The Non-Baseline ethanol formulations are sorted into groups based on the non-ethanol, non-gasoline component(s) of the blended fuel. Each such component occurring separately and each unique combination of such components shall define a separate group.
( 1 ) The representative of each such non-baseline ethanol group shall be the group member with the highest percent by volume of non-ethanol, non-gasoline component(s).
( 2 ) In case two or more such members have the same and highest concentration of non-ethanol, non-gasoline component(s), the representative of the group shall be chosen at random from among such equivalent member products.
(E) Non-Baseline Methane. The Non-Baseline methane category consists of one group. The group representative shall be the member fuel or fuel/additive formulation containing the highest concentration-in-use of non-methane hydrocarbons. If two or more member products have the same and the highest concentration-in-use, then the representative shall be chosen at random from such products.
(F) Non-baseline propane. The Non-Baseline propane category consists of one group. The group representative shall be the member fuel or fuel/additive formulation containing the highest concentration-in-use of butane and higher hydrocarbons. If two or more products have the same and the highest concentration-in-use, then the representative shall be chosen at random from such products.
(iii) Atypical groups. (A) As defined for each individual fuel family in § 79.56(e)(3), fuels and additives meeting any one of the following criteria are considered atypical.
( 1 ) Gasoline Atypical fuels and additives contain one or more elements in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur.
( 2 ) Diesel Atypical fuels and additives contain one or more element in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur.
( 3 ) Methanol Atypical fuels and additives contain:
( i ) one or more element in addition to carbon, hydrogen, oxygen, nitrogen, sulfur, and chlorine, and/or
( ii ) sulfur in excess of 0.004 percent by weight, and/or
( iii ) chlorine in excess of 0.0001 percent by weight.
( 4 ) Ethanol Atypical fuels and additives contain:
( i ) one or more element in addition to carbon, hydrogen, oxygen, nitrogen, sulfur, chlorine, and copper, and/or
( ii ) sulfur in excess of 0.004 percent by weight, and/or
( iii ) contain chlorine (as chloride) in excess of 0.0004 percent by weight, and/or
( iv ) contain copper in excess of 0.07 mg/L.
( 5 ) Methane Atypical fuels and additives contain:
( i ) one or more element in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur, and/or
( ii ) sulfur in excess of 16 ppm by volume.
( 6 ) Propane Atypical fuels and additives contain:
( i ) one or more element in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur, and/or
( ii ) sulfur in excess of 123 ppm by weight.
(B) General rules for sorting these atypical fuels and additives into separate groups are as follows:
( 1 ) Pursuant to § 79.51(j), a given atypical product may belong to more than one atypical group.
( 2 ) Fuels and additives in different fuel families may not be grouped together, even if they contain the same atypical element(s) or other atypical characteristic(s).
( 3 ) A fuel or additive containing one or more atypical elements attached to a polymer compound must be sorted into a separate group from atypical fuels or fuel additives containing the same atypical element(s) in non-polymer form. However, the occurrence of a polymer compound which does not contain an atypical element does not affect the grouping of a fuel or additive.
(C) Specific rules for sorting each family's atypical fuels and additives into separate groups, and for choosing each such group's representative for testing, are as follows:
( 1 ) A separate group is created for each atypical element (or other atypical characteristic) occurring separately, i.e., in the absence of any other atypical element or characteristic, in one or more fuels and/or additives within a given fuel family.
( i ) Consistent with the basic grouping guidelines provided in § 79.56(d), a fuel product which is classified as atypical because its basic registration data or application lists a bulk additive containing an atypical characteristic, may be grouped with that additive and/or with other fuels and additives containing the same atypical characteristic.
( ii ) Within a group of products containing only one atypical element or characteristic, the fuel or additive/base fuel mixture with the highest concentration-in-use or recommended concentration-in-use of the atypical element or characteristic shall be the designated representative of that group. In the event that two or more fuels or additive/base fuel mixtures within the group contain the same and highest concentration of the single atypical element or characteristic, then the group representative shall be selected by a random method from among such candidate products.
( 2 ) A separate group is also created for each unique combination of atypical elements (and/or other specified atypical characteristics) occurring together in one or more fuels and/or additives within a given fuel family.
( i ) Consistent with the basic grouping guidelines provided in § 79.56(d), a fuel which is classified as atypical because its basic registration data lists one bulk additive containing two or more atypical characteristics, may be grouped with that additive and/or with other fuels and/or additives containing the same combination of atypical characteristics. Grouping of fuels containing more than one atypical additive shall be guided by provisions of § 79.51(j).
( ii ) Within a group of such products containing a unique combination of two or more atypical elements or characteristics, the designated representative shall be the product within the group which contains the highest total concentration of the atypical elements or characteristics.
( iii ) In the event that two or more products within a given atypical group contain the same and highest concentration of the same atypical elements or characteristics then, among such candidate products, the designated representative shall be the product which, first, has the highest total concentration of metals, followed in order by highest total concentration of halogens, highest total concentration of other atypical elements (including sulfur concentration, as applicable), highest total concentration of polymers containing atypical elements, and, lastly, highest total concentration of oxygen.
( iv ) If two or more products have the same and highest concentration of the variable identified in the preceding paragraph, then, among such products, the one with the greatest concentration of the next highest variable on the list shall be the group representative.
( v ) This decision-making process shall continue until a single product is determined to be the representative. If two or more products remain tied at the end of this process, then the representative shall be chosen by a random method from among such remaining products.
§ 79.57   Emission generation.
This section specifies the equipment and procedures that must be used in generating the emissions which are to be subjected to the characterization procedures and/or the biological tests specified in §§ 79.52(b) and 79.53 of these regulations. When applicable, they may also be required in conjunction with testing under §§ 79.54 and 79.58(c). Additional requirements concerning emission generation, delivery, dilution, quality control, and safety practices are outlined in § 79.61.
(a) Vehicle and engine selection criteria. (1) All vehicles and engines used to generate emissions for testing a fuel or additive/fuel mixture must be new (i.e., never before titled) and placed into the program with less than 500 miles on the odometer or 12 hours on the engine chronometer. The vehicles and engines shall be unaltered from the specifications of the original equipment manufacturer.
(2) The vehicle/engine type, vehicle/engine class, and vehicle/engine subclass designated to generate emissions for a given fuel or additive shall be the same type, class, and subclass which, over the previous three years, has consumed the most gallons of fuel in the fuel family applicable to the given fuel or additive. No distinction shall be made between light-duty vehicles and light-duty trucks for purposes of this classification.
(3) Within this vehicle/engine type, class, and subclass, the specific vehicles and engines acceptable for emission generation are those that represent the most common fuel metering system and the most common of the most important emission control system devices or characteristics with respect to emission reduction performance for the model year in which testing begins. These vehicles will be determined through a survey of the previous model year's vehicle/engine sales within the given subclass. These characteristics shall include, but need not be limited to, aftertreatment device(s), fuel aspiration, air injection, exhaust gas recirculation, and feedback type.
(4) Within the applicable subclass, the five highest selling vehicle/engine models that contain the most common such equipment and characteristics shall be determined. Any of these five models of the current model year (at the time testing begins) may be selected for emission generation.
(i) If one or more of the five models is not available for the current model year, the choice of model for emission generation shall be limited to those remaining among the five.
(ii) If fewer than five models of the given vehicle/engine type are available for the current model year, all such models shall be eligible.
(5) When the fuel or fuel additive undergoing testing is not commonly used or intended to be used in the vehicle/engine types prescribed by this selection procedure, or when rebuilding or alteration is required to obtain a suitable vehicle/engine for emission generation, the manufacturer may submit a request to EPA for a modification in test procedure requirements. Any such request must include objective test results which support the claim that a more appropriate vehicle/engine type is needed as well as a suggested substitute vehicle/engine type. The vehicle/engine selection in this case shall be approved by EPA prior to the start of testing.
(6) Once a particular model has been chosen on which to test a fuel or additive product, all mileage accumulation and generation of emissions for characterization and biological testing of such product shall be conducted on that same model.
(i) If the initial test vehicle/engine fails or must be replaced for any reason, emission generation shall continue with a second vehicle/engine which is identical to, or resembles to the greatest extent possible, the initial test vehicle/engine. If more than one replacement vehicle/engine is necessary, all such vehicles/engines shall be identical, or resemble to the greatest extent possible, the initial test vehicle/engine.
(ii) Manufacturers are encouraged to obtain, at the start of a test program, more than one emission generation vehicle/engine of the identical model, to ensure the availability of back-up emission generator(s). All backup vehicles/engines must be conditioned and must have their emissions fully characterized, as done for the initial test vehicle/engine, prior to their use as emission generators for biological testing. Alternating between such vehicles/engines regularly during the course of testing is permissible and advisable, particularly to allow regular maintenance on such vehicles/engines during prolonged health effects testing.
(b) Vehicle/engine operation and maintenance. (1) For the purpose of generating combustion emissions from a fuel or additive/base fuel mixture for which the relevant class is light duty, either a light-duty vehicle shall be operated on a chassis dynamometer or a light-duty engine shall be operated on an engine dynamometer. When the relevant class is heavy duty, the emissions shall be generated on a heavy-duty engine operated on an engine dynamometer. In both cases, the vehicle or engine model shall be selected as described in paragraph (a) of this section and shall have all applicable fuel and emission control systems intact.
(2) Except as provided in § 79.51(h)(2)(iii), the fuel or additive/base fuel mixture being tested shall be used at all times during operation of the test vehicle or engine. No other fuels or additives shall be used in the test vehicle or engine once mileage accumulation has begun until emission generation for emission characterization and biological testing purposes is completed.
(i) A vehicle or engine may be used to generate emissions for the testing of more than one fuel or additive, provided that all such fuels and additives belong to the same fuel family pursuant to § 79.56(e)(i), and that, once a vehicle or engine has been used to generate emissions for an atypical fuel or additive (pursuant to § 79.56(e)(2)(iii)), it shall not be used in the testing of any other fuel or additive. Paragraphs (a) (2) and (3) of this section shall apply only to the first fuel or additive tested.
(ii) Prior to being used to generate emissions for testing an additional fuel or additive, a vehicle or engine which has previously been used for testing a different fuel or additive shall undergo an effective intermediate preconditioning cycle to remove the previously used fuel and its emissions from the vehicle's fuel and exhaust systems and from the combustion emission and evaporative emission control systems, if any.
(iii) Such preconditioning shall include, at a minimum, the following steps:
(A) The canister (if any) shall be removed from the vehicle and purged with 300 °F nitrogen at 20 liters per minute until the incremental weight loss of the canister is less than 1 gram in 30 minutes. This typically takes 3-4 hours and removes 100 to 120 grams of adsorbed gasoline vapors.
(B) The fuel tank shall be drained and filled to capacity with the new test fuel or additive/fuel mixture.
(C) The vehicle or engine shall be operated until at least 95% of the fuel tank capacity is consumed.
(D) The purged canister shall be returned to the vehicle.
(E) The fuel tank shall be drained and filled to 40% capacity with test fuel.
(F) Two-hour fuel tank heat builds from 72-120 °F shall be performed repeatedly as necessary to achieve canister breakthrough. The fuel tank must be drained and filled prior to each heat build.
(3) Scheduled and unscheduled vehicle/engine maintenance. (i) During emission generation, vehicles and engines must be maintained in good condition by following the recommendations of the original equipment manufacturer (OEM) for scheduled service and parts replacement, with repairs performed only as necessary. Modifications, adjustments, and maintenance procedures contrary to procedures found in 40 CFR part 86 for the maintenance of test vehicles/engines or performed solely for the purpose of emissions improvement are not allowed.
(ii) If unscheduled maintenance becomes necessary, the vehicle or engine must be repaired to OEM specifications, using OEM or OEM-approved parts. In addition, the tester is required to measure the basic emissions pursuant to § 79.52(b)(2)(i) after the unscheduled maintenance and before resuming testing to ensure that the post-maintenance emissions shall be within 20 percent of pre-maintenance emissions levels. If the basic emissions cannot be brought within 20 percent of their previous levels, then the manufacturer shall restart the emissions characterization and health testing of its products combustion emissions using a new vehicle/engine.
(c) Mileage accumulation. (1) A vehicle/engine break-in period is required prior to generating emissions for characterization and/or biological testing under this subpart. The required mileage accumulation may be accomplished on a test track, on the street, on a dynamometer, or using any other conventionally accepted method.
(2) Vehicles to be used in the evaluation of baseline and non-baseline fuels and fuel additives shall accumulate 4,000 miles prior to emission testing. Engines to be used in the evaluation of baseline and non-baseline fuels and fuel additives shall accumulate 125 hours of operation on an engine dynamometer prior to emission testing.
(3) When the test formulation is classified as an atypical fuel or fuel additive formulation (pursuant to definitions in § 79.56(e)(4)(iii)), the following additional mileage accumulation requirements apply:
(i) The test vehicle/engine must be operated for a minimum of 4,000 vehicle miles or 125 hours of engine operation.
(ii) Thereafter, at intervals determined by the tester, all emission fractions ( i.e., vapor, semi-volatile, and particulate) shall be sampled and analyzed for the presence and amount of the atypical element(s) and/or other atypical constituents. Pursuant to paragraph (d) of this section, the sampled emissions must be generated in the absence of an intact aftertreatment device. Immediately before the samples are taken, a brief warmup period (at least ten miles or the engine equivalent) is required.
(iii) Mileage accumulation shall continue until either 50 percent or more of the mass of each atypical element (or other atypical constituent) entering the engine can be measured in the exhaust emissions (all fractions combined), or the vehicle/engine has accumulated mileage (or hours) equivalent to 40 percent of the average useful life of the applicable vehicle/engine class (pursuant to regulations in 40 CFR part 86). For example, the maximum mileage required for light-duty vehicles is 40 percent of 100,000 miles ( i.e., 40,000 miles), while the maximum time of operation for heavy-duty engines is the equivalent of 40 percent of 290,000 miles ( i.e., the equivalent in engine hours of 116,000 miles).
(iv) When either condition in paragraph (c)(3)(iii) of this section has been reached, additional emission characterization and biological testing of the emissions may begin.
(d) Use of exhaust aftertreatment devices. (1) If the selected test vehicle/engine, as certified by EPA, does not come equipped with an emissions aftertreatment device (such as a catalyst or particulate trap), such device shall not be used in the context of this program.
(2) Except as provided in paragraph (d)(3) of this section for certain specialized additives, the following provisions apply when the test vehicle/engine, as certified by EPA, comes equipped with an emissions aftertreatment device.
(i) For mileage accumulation:
(A) When the test formulation does not contain any atypical elements (pursuant to definitions in § 79.56(e)(4)(iii)), an intact aftertreatment device must be used during mileage accumulation.
(B) When the test formulation does contain atypical elements, then the manufacturer may choose to accumulate the required mileage using a vehicle/engine equipped with either an intact aftertreatment device or with a non-functional aftertreatment device (e.g., a blank catalyst without its catalytic wash coat). In either case, sampling and analysis of emissions for measurement of the mass of the atypical element(s) (as described in § 79.57(c)(3)) must be done on emissions generated with a non-functional (blank) aftertreatment device.
( 1 ) If the manufacturer chooses to accumulate mileage without a functional aftertreatment device, and if the manufacturer wishes to do this outside of a laboratory/test track setting, then a memorandum of exemption for product testing must be obtained by applying to the Director of the Field Operations and Support Division (see § 79.59(a)(1)).
( 2 ) [Reserved]
(ii) For Tier 1 (§ 79.52), the total set of requirements for the characterization of combustion emissions (§ 79.52(b)) must be completed two times, once using emissions generated with the aftertreatment device intact and a second time with the aftertreatment device rendered nonfunctional or replaced with a non-functional aftertreatment device as described in paragraph (d)(2)(i)(B) of this section.
(iii) For Tier 2 (§ 79.53), the standard requirements for biological testing of combustion emissions shall be conducted using emissions generated with a non-functioning aftertreatment device as described in paragraph (d)(2)(i)(B) of this section.
(iv) For alternative Tier 2 requirements (§ 79.58(c)) or Tier 3 requirements (§ 79.54) which may be prescribed by EPA, the use of functional or nonfunctional aftertreatment devices shall be specified by EPA as part of the test guidelines.
(v) In the case where an intact aftertreatment device is not in place, all other manufacturer-specified combustion characteristics (e.g., back pressure, residence time, and mixing characteristics) of the altered vehicle/engine shall be retained to the greatest extent possible.
(3) Notwithstanding paragraphs (d)(1) and (d)(2) of this section, when the subject of testing is a fuel additive specifically intended to enhance the effectiveness of exhaust aftertreatment devices, the related aftertreatment device may be used on the emission generation vehicle/engine during all mileage accumulation and testing.
(e) Generation of combustion emissions —(1) Generating combustion emissions for emission characterization. (i) Combustion emissions shall be generated according to the exhaust emission portion of the Federal Test Procedure (FTP) for the certification of new motor vehicles, found in 40 CFR part 86, subpart B for light-duty vehicles/engines, and subparts D, M and N for heavy-duty vehicles/engines. The Urban Dynamometer Driving Schedule (UDDS), pursuant to 40 CFR part 86, appendix I(a), shall apply to light-duty vehicles/engines and the Engine Dynamometer Driving Schedule (EDS), pursuant to 40 CFR part 86, appendix I(f)(2), shall apply to heavy-duty vehicles/engines. The motoring portion of the heavy-duty test cycle may be eliminated, at the manufacturer's option, for the generation of emissions.
(A) For light-duty engines operated on an engine dynamometer, the tester shall determine the speed-torque equivalencies (“trace”) for its test engine from valid FTP testing performed on a chassis dynamometer, using a test vehicle with an engine identical to that being tested. The test engine must then be operated under these speed and torque specifications to simulate the FTP cycle.
(B) Special procedures not included in the FTP may be necessary in order to characterize emissions from fuels and fuel additives containing atypical elements or to collect some types of emissions (e.g., particulate emissions from light-duty vehicles/engines, semi-volatile emissions from both light-duty and heavy-duty vehicles/engines). Such alterations to the FTP are acceptable.
(C) For Tier 2 testing, the engines shall operate on repeated bags 2 and 3 of the UDDS or back to back repeats of the heavy-duty transient cycle of the EDS.
(ii) Pursuant to § 79.52(b)(1)(i) and § 79.57(d)(2)(ii), emission generation and characterization must be repeated three times when the selected vehicle/engine is normally operated without an emissions aftertreatment device and six times when the selected vehicle/engine is normally operated with an emissions aftertreatment device. In the latter case, the emission generation and characterization process shall be repeated three times with the intact aftertreatment device in place and three times with a non-functioning (blank) aftertreatment device in place.
(iii) From both light-duty and heavy-duty vehicles/engines, samples of vapor phase, semi-volatile phase, and particulate phase emissions shall be collected, except that semi-volatile phase, and particulate emissions need not be sampled for fuels and additives in the methane and propane families (pursuant to § 79.56(e)(1)(v) and (vi)). The number and type of samples to be collected and separately analyzed during one emission generation/characterization process are as follows:
(A) In the case of combustion emissions generated from light-duty vehicles/engines, the samples consist of three bags of vapor emissions (one from each segment of the light-duty exhaust emission cycle) plus one sample of particulate-phase emissions and one sample of semi-volatile-phase emissions (collected over all segments of the exhaust emission cycle). If the mass of particulate emissions or semi-volatile emissions obtained during one driving cycle is not sufficient for characterization, up to three driving cycles may be performed and the extracted fractions combined prior to chemical analysis. Particulate-phase emissions shall not be combined with semi-volatile-phase emissions. The test laboratory should focus on the characterization of the limit of detection for particulates and semi-volatile emissions.
(B) In the case of combustion emissions generated from heavy-duty engines, the samples consist of one sample of each emission phase (vapor, particulate, and semi-volatile) collected over the entire cold-start cycle and a second sample of each such phase collected over the entire hot-start cycle (see 40 CFR 86.334 through 86.342).
(iv) Emission collection and storage. (A) Vapor phase emissions shall be collected and stored in Tedlar bags for subsequent chemical analysis. Storage conditions are specified in § 79.52(b)(2).
(B) Particulate phase emissions shall be collected on a particulate filter (or more than one, if required) using methods described in 40 CFR 86.1301 through 86.1344. These methods, ordinarily applied only to heavy-duty emissions, are to be adapted and used for collection of particulates from light-duty vehicles/engines, as well. The particulate matter may be stored on the filter in a sealed container, or the soluble organic fraction may be extracted and stored in a separate sealed container. Both the particulate and the extract shall be shielded from ultraviolet light and stored at −20 °C or less. Particulate emissions shall be tested no later than six months from the date they were generated.
(C) Semi-volatile emissions shall be collected immediately downstream from the particulate collection filters using porous polymer resin beds, or their equivalent, designed for their capture. The soluble organic fraction of semi-volatile emissions shall be extracted immediately and tested within six months of being generated. The extract shall be stored in a sealed container which is shielded from ultraviolet light and stored at −20 °C or less.
(D) Particulate and semi-volatile phase emission collection, handling and extraction methods shall not alter the composition of the collected material, to the extent possible.
(v) Additional requirements for combustion emission sampling, storage, and characterization are specified in § 79.52(b).
(2) Generating whole combustion emissions for biological testing. (i) Biological tests requiring whole combustion emissions shall be conducted using emissions generated from the test vehicle or engine operated in accordance with general FTP requirements.
(ii) Light-duty test vehicles/engines shall be repeatedly operated over the Urban Dynamometer Driving Schedule (UDDS) (or equivalent engine dynamometer trace, per paragraph (e)(1)(i)(A) of this section) and heavy-duty test engines shall be repeatedly operated over the Engine Dynamometer Schedule (EDS) (see 40 CFR part 86, appendix I).
(A) The tolerances of the driving cycle shall be two times those of the Federal Test Procedure and must be met 95 percent of the time.
(B) The UDDS or EDS shall be repeated as many times as required for the biological test session.
(C) Light-duty dynamometers shall be calibrated prior to the start of a biological test (40 CFR 86.118-78), verified weekly (40 CFR 86.118-78), and recalibrated as required. Heavy-duty dynamometers shall be calibrated and checked prior to the start of a biological test (40 CFR 86.1318-84), recalibrated every two weeks (40 CFR 86.1318-84(a)) and checked as stated in 40 CFR 86.1318-84(b) and (c).
(D) The fuel reservoir for the test vehicle/engine shall be large enough to operate the test vehicle/engine throughout the daily biological exposure period, avoiding the need for refueling during testing.
(iii) An apparatus to integrate the large concentration swings typical of transient-cycle exhaust is to be used between the source of emissions and the exposure chamber containing the animal test cages(s). The purpose of such apparatus is to decrease the variability of the biological exposure atmosphere and achieve the necessary concentration of CO or NO X , whichever is limiting.
(A) A large mixing chamber is suggested for this purpose. The mixing chamber would be charged from the CVS at a constant rate determined by the exposure chamber purge rate. Flow to the exposure chamber would begin at the conclusion of the initial transient cycle with the associated mixing chamber charge.
(B) A potential alternative apparatus is a mini-diluter (see, for example, AIGER/CRADA, February, 1994 in § 79.57(g)).
(C) [Reserved]
(iv) Emission dilution. (A) Dilution air can be pre-dried to lower the relative humidity, thus permitting a lower dilution rate and a higher concentration of hydrocarbons to be achieved without condensation of water vapor.
(B) These procedures include requirements that the mean exposure concentration in the inhalation test chamber on 90 percent or more of the exposure days shall be controlled as follows:
( 1 ) If the species being controlled is hydrocarbon or particulate, the mean exposure concentration must be within 15 percent of the target concentration for the single species being controlled.
( 2 ) For other species, the mean exposure concentration must be within 10 percent of the target concentration for the single species being controlled.
( 3 ) For all species, daily monitoring of CO, CO 2 , NO X , SO X , and total hydrocarbons in the exposure chamber shall be required. Analysis of the particle size distribution shall also be performed to establish the stability and consistency of particle size distribution in the test exposure.
(C) After the initial exhaust dilution to preserve the character of the exhaust, the exhaust stream can be further diluted in the mixing chamber (and/or after leaving the chamber) to achieve the desired biological exposure concentrations.
(v) Verification procedures. (A) The entire system used to dilute and transport whole combustion emissions ( i.e., from exhaust pipe to outlet in the biological testing chamber) shall be verified before any animal exposures begin, and verified at least weekly during testing. (See procedures at 40 CFR 86.119-90 for light-duty vehicles and § 86.1319-90 for heavy-duty engines.) Verification testing shall be accomplished by introducing a known sample at the end of the vehicle/engine exhaust pipe into the dilution system and measuring the amount exiting the system. For example, an injected hydrocarbon sample could be detected with a gas chromatograph (GC) and flame ionization detector (FID) to determine the recovery factor.
(B) [Reserved]
(vi) Emission exposure quality control. (A) The tester shall incorporate the additional quality assurance and safety procedures outlined in § 79.61(d) to control variability of emissions during the generation of exposure emissions during health effect testing.
(B) These procedures include requirements that the mean exposure concentration in the inhalation test chamber on 90 percent or more of the exposure days shall be controlled as follows:
( 1 ) If the species being controlled is hydrocarbon or particulate, the mean exposure concentration must be within 15 percent of the target concentration for the single species being controlled.
( 2 ) For other species, the mean exposure concentration must be within 10 percent of the target concentration for the single species being controlled.
( 3 ) For all species, daily monitoring of CO, CO 2 , NO X , SO X , and total hydrocarbons in the exposure chamber shall be required. Analysis of the particle size distribution shall also be performed to establish the stability and consistency of particle size distribution in the test exposure.
(C) The testing facility shall allow an audit of its premises, the qualifications, e.g., curriculum vitae, of its staff assigned to testing, and the specimens and records of the testing for registration purposes (as specified in § 79.60).
(vii) To allow for customary laboratory scheduling and unforeseen problems affecting the combustion emission generation or dilution equipment, biological exposures may be interrupted on limited occasions, as specified in § 79.61(d)(5). Interruptions exceeding these limitations shall cause the affected test(s) to be void. Testers shall be aware of concerns for backup vehicles/engines cited in paragraph (a)(7)(ii) of this section.
(3) Generating particulate and semi-volatile emissions for biological testing. (i) Salmonella mutagenicity testing, pursuant to § 79.68, shall be conducted on extracts of the particulate and semi-volatile emission phases separately. These emissions shall be generated by operating the test vehicle/engine over the appropriate FTP driving schedule (see paragraph (e)(2)(ii) of this section) and collected and analyzed according to methods described in 40 CFR 86.1301 through 1344 (further information on this subject may be found in Perez, et al. CRC Report No. 551, 1987 listed in § 79.57(g)).
(A) Particulate emissions shall be collected on particulate filters and extracted from the collection equipment for use in biological tests. The number of repetitions of the applicable driving schedule required to collect sufficient quantities of the particulate emissions will vary, depending on the characteristics of the engine, the test fuel, and the requirements of the biological test protocol. The particulate sample may be collected on one or more filters, as necessary.
(B) Semi-volatile emissions shall be collected immediately downstream from the particulate collection filters using porous polymer resin beds, or their equivalent, designed for their capture. Semi-volatile phase emissions shall be collected on one apparatus. The time spent collecting sufficient quantities of the test substances in emissions samples will vary, depending on the emission characteristics of the engine and fuel or additive/base fuel mixture and on the requirements of the biological test protocol.
(ii) The extraction method shall be determined by the specifications of the biological test for which the emissions are used.
(iii) Particulate and semi-volatile emission storage requirements are as specified in § 79.57(e)(1)(iv).
(iv) Particulate and semi-volatile phase emission collection, handling and extraction methods shall not alter the composition of the collected material, to the extent possible.
(v) Particulate emissions shall not be combined with semi-volatile phase emissions.
(f) Generation of evaporative emissions for characterization and biological testing. (1) Except as provided in paragraph (f)(5) of this section, an evaporative emissions generator shall be used to volatilize samples of a fuel or additive/base fuel mixture for evaporative emissions characterization and biological testing. Emissions shall be collected and sampled using equipment and methods appropriate for use with the compounds being characterized and the requirements of the emission characterization analysis. In the case of potentially explosive test substance concentrations, care must be taken to avoid generating explosive atmospheres. The tester is referred to § 79.61(d)(8) for considerations involving explosivity.
(2) Evaporative Emissions Generator (EEG) Description. An EEG is a fuel tank or vessel to which heat is applied causing a portion of the fuel to evaporate at a desired rate. The manufacturer has flexibility in designing an EEG for testing a particular fuel or fuel additive. The sample used to generate emissions in the EEG shall be renewed at least daily.
(i) The evaporation chamber shall be made from materials compatible with the fuels and additives being tested and shall be equipped with a drain.
(ii) The chamber shall be filled to 40 ±5 percent of its interior volume with the fuel or additive/base fuel mixture being tested, with the remainder of the volume containing air.
(iii) The concentration of the evaporated fuel or additive/base fuel mixture in the vapor space of the evaporation chamber during the time emissions are being withdrawn for testing shall not vary by more than 10 percent from the equilibrium concentration in the vapor space of emissions generated from the fresh fuel or additive/base fuel mixture in the chamber.
(A) During the course of a day's emission generation period, the level of fuel in the EEG shall be maintained to within 7 percent of its height at the start of the daily exposure period.
(B) The fuel used in the EEG shall be drained at the end of each daily exposure. The EEG shall be refilled with a fresh supply of the test formulation before the start of each daily exposure.
(C) The vapor space of the evaporation chamber shall be well mixed throughout the time emissions are being withdrawn for testing.
(iv) The size of the evaporation chamber shall be determined by the rate at which evaporative emissions shall be needed in the test animal exposure chambers and the rate at which the fuel or the additive/base fuel mixture evaporates. The rate of evaporative emissions may be adjusted by altering the size of the EEG or by using one or more additional EEG(s). Emission rate modifications shall not be adjusted by temperature control or pressure control.
(v) The temperature of the fuel or additive/base fuel mixture in the evaporation chamber shall be 130 °F ±5 °F. The vapors shall maintain this temperature up to the point in the system where the vapors are diluted.
(vi) The pressure in the vapor space of the evaporation chamber and the dilution and sampling apparatus shall stay within 10 percent of ambient atmospheric pressure.
(vii) There shall be no controls or equipment on the evaporation chamber system that change the concentration or composition of the vapors generated for testing.
(viii) Manufacturers shall perform verification testing of evaporative emissions in a manner analogous to the verification testing performed for combustion emissions.
(3) For biological testing, vapor shall be withdrawn from the EEG at a constant rate, diluted with air as required for the particular study, and conducted immediately to the biological testing chamber(s) in a manner similar to the method used in § 79.57(e), excluding the mixing chamber therein. The rate of emission generation shall be high enough to supply the biological exposure chamber with sufficient emissions to allow for a minimum of fifteen air changes per exposure chamber per hour. To allow for customary laboratory scheduling and for unforeseen problems with the evaporative emission generation or dilution equipment, biological exposures may be interrupted on limited occasions, as specified in § 79.61(d)(5). Interruptions exceeding these limitations shall cause the affected test(s) to be void.
(4) For characterization of evaporative emissions, samples of equilibrated emissions to the vapor space of the EEG shall be withdrawn into Tedlar bags, then stored and analyzed as specified in § 79.52(b).
(5) A manufacturer (or group of manufacturers) may submit to EPA a request for approval of an alternative method of generating evaporative emissions for use in emission characterization and biological tests required under this subpart.
(i) To be approved by EPA, the request must fully explain the rationale for the proposed method as well as the technical procedures, quality control, and safety precautions to be used, and must demonstrate that the proposed method will meet the following criteria:
(A) The emission mixture generated by the proposed procedures must be reasonably similar to the equilibrium composition of the vapor which occurs in the vehicle fuel tank head space when the subject fuel or additive/base fuel mixture is in use and near-maximum in-use temperatures are encountered.
(B) The emissions mixture generated by the proposed method must be sufficiently concentrated to provide adequate exposure levels in the context of the required toxicologic tests.
(C) The proposed method must include procedures to ensure that the emissions delivered to the biologic exposure chambers will provide a reasonably constant exposure atmosphere over time.
(ii) If EPA approves the request, EPA will place in the public record a copy of the request, together with all supporting procedural descriptions and justifications, and will notify the public of its availability by publishing a notice in the Federal Register.
(g) References. For additional background information on the emission generation procedures outlined in this paragraph (g), the following references may be consulted. Additional references can be found in § 79.61(f).
(1) AIGER/CRADA (American Industry/Government Emissions Research Cooperative Research and Development Agreement, “Specifications for Advanced Emissions Test Instrumentation” AIGER PD-94-1, Revision 5.0, February, 1994
(2) Black, F. and R. Snow, “Constant Volume Sampling System Water Condensation” SAE #940970 in “Testing and Instrumentation” SP-1039, Society of Automotive Engineers, Feb. 28-Mar. 3, 1994.
(3) Perez, J.M., Jass, 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.
(4) Phalen, R.F., “Inhalation Studies: Foundations and Techniques”, CRC Press, Inc., Boca Raton, Florida, 1984.
§ 79.58   Special provisions.
(a) Relabeled Additives. Sellers of relabeled additives (pursuant to § 79.50) are not required to comply with the provisions of § 79.52, 79.53 or 79.59, except that such sellers are required to comply with § 79.59(b).
(b) Low Vapor Pressure Fuels and Additives. Fuels which are not designated as “evaporative fuels” and fuel additives which are not designated as “evaporative fuel additives” pursuant to the definitions in § 79.50 need not undergo the emission characterization or health effects testing specified in §§ 79.52 and 79.53 for evaporative emissions. At EPA's discretion, the evaporative emissions of such fuels and additives may be required to undergo Tier 3 testing, pursuant to § 79.54.
(c) Alternative Tier 2 Provisions. At EPA's discretion, EPA may modify the standard Tier 2 health effects testing requirements for a fuel or fuel additive (or group). Such modification may encompass substitution, addition, or deletion of Tier 2 studies or study specifications, and/or changes in underlying engine or equipment requirements, except that a Tier 2 endpoint will not be deleted in the absence of existing information deemed adequate by EPA or alternative testing requirements for such endpoint. If warranted by the particular requirements, EPA will allow additional time for completion of the alternative Tier 2 testing program.
(1) When EPA intends to require testing in lieu of or in addition to standard Tier 2 health testing, EPA will notify the responsible manufacturer (or group) by certified letter of the specific tests which EPA is proposing to require in lieu of or in addition to Tier 2, and the proposed schedule for completion and submission of such tests. A copy of the letter will be placed in the public record. EPA intends to send the notification prior to November 27, 1995, or in the case of new fuels and additives (as defined in § 79.51(c)(3)), within 18 months of EPA's receipt of an intent to register such product. However, EPA's notification to the manufacturer (or group) may occur at any time up to EPA's receipt of Tier 2 data for the product(s) in question. EPA will provide the manufacturer with 60 days from the date of receipt of the notice to comment on the tests which EPA is proposing to require and on the proposed schedule. If the manufacturer believes that undue costs or hardships will occur as a result of EPA's delay in providing notification of alternative Tier 2 requirements, then the manufacturer's comments should describe and include evidence of such hardship. In particular, if the standard Tier 2 toxicology testing for the fuel or additive in question has already begun at the time the manufacturer receives EPA's notification of proposed alternative Tier 2 requirements, then EPA shall refrain from requiring alternative Tier 2 tests provided that EPA receives the standard Tier 2 data and report (pursuant to § 79.59(c)) within one year of the date on which the toxicology testing began.
(2) EPA will issue a notice in the Federal Register announcing its intent to require special testing in lieu of or in addition to the standard Tier 2 testing for a particular fuel or additive manufacturer or group, and that a copy of the letter to the manufacturer or group describing the proposed alternative Tier 2 testing for that manufacturer or group is available in the public record for review and comment. The public shall have a minimum of 30 days after the publication of this notice to comment on the proposed alternative Tier 2 testing.
(3) EPA will include in the public record a copy of any timely comments concerning the proposed alternative Tier 2 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 may adopt final alternative Tier 2 requirements by sending a certified letter describing such final requirements to the manufacturer or group. In that event, EPA will also issue a notice in the Federal Register announcing that it has adopted final alternative Tier 2 requirements and that a copy of the letter adopting the requirements has been included in the public record.
(4) After EPA's receipt of a manufacturer's (or group's) submittals, EPA will notify the responsible manufacturer (or group) regarding the adequacy of the submittal and potential Tier 3 testing requirements according to the same relative time intervals and by the same procedures as specified in § 79.51 (c) and (d) for routine Tier 1 and Tier 2 submittals.
(d) Small Business Provisions. (1) For purposes of these provisions, when subsidiary, divisional, or other complex business arrangements exist, manufacturer is defined as the business entity with ultimate ownership of all related parents, subsidiaries, divisions, branches, or other operating units. Total annual sales means the average of the manufacturer's total sales revenue, excluding any revenue which represents the collection of Federal, State, or local excise taxes or sales taxes, in each of the three years prior to such manufacturer's submittal to EPA of the basic registration information pursuant to § 79.59(b)(2) through (b)(5).
(2) Provisions Applicable to Baseline and Non-baseline Products. A manufacturer with total annual sales less than $50 million is not required to meet the requirements of Tier 1 and Tier 2 (specified in §§ 79.52 and 79.53) with regard to such manufacturer's fuel and/or additive products which meet the criteria for inclusion in a Baseline or Non-baseline group pursuant to § 79.56. Upon such manufacturer's satisfactory completion and submittal to EPA of basic registration data specified in § 79.59(b), the manufacturer may request and EPA shall issue a registration for such product, subject to § 79.51(c) and paragraphs (d)(4) and (d)(5) of this section.
(3) Provisions Applicable to Atypical Products. A manufacturer with total annual sales less than $10 million is not required to meet the requirements of Tier 2 (specified in § 79.53) in regard to such manufacturer's fuel and/or additive products which meet the criteria for inclusion in an Atypical group pursuant to § 79.56. Upon such manufacturer's satisfactory completion and submittal to EPA of basic registration data specified in § 79.59(b) and Tier 1 information specified in § 79.52 for an Atypical fuel or additive, the manufacturer may request and EPA shall issue a registration for such product, subject to § 79.51(c) and paragraphs (d)(4) and (d)(5) of this section. Compliance with Tier 1 requirements under this paragraph may be accomplished by the individual manufacturer or as a part of a group pursuant to § 79.56.
(4) Any registration granted by EPA under the provisions of this section are conditional upon satisfactory completion of any Tier 3 requirements which EPA may subsequently impose pursuant to § 79.54. In such circumstances, the Tier 3 requirements might include (but would not necessarily be limited to) information which would otherwise have been required under the provisions of Tier 1 and/or Tier 2.
(5) The provisions in paragraphs (d)(2) and (d)(3) of this section are voluntary on the part of qualifying small manufacturers. Such manufacturers may choose to fulfill the standard requirements for their fuels and additives, individually or as a part of a group, rather than satisfying only the requirements specified in paragraphs (d)(2) and/or (d)(3) of this section. If a qualifying small manufacturer elects these special provisions rather than the standard requirements for a product, then EPA will generally assume that any additional information submitted by other manufacturers, for fuels and additives meeting the same grouping criteria (under § 79.56) as that of the small manufacturer's product, is pertinent to further testing and/or regulatory decisions that may affect the small manufacturer's product.
(6) In the case of an additive for which the manufacturer is not required to meet the requirements of Tier 2 pursuant to paragraph (d)(3) of this section:
(i) A fuel manufacturer which blends such an additive into fuel shall not be required to meet the requirements of Tier 2 with respect to such additive/fuel mixture.
(ii) An additive manufacturer which blends such an additive with one or more other registered additive products and/or with substances containing only carbon and/or hydrogen shall not be required to meet the requirements of Tier 2 with respect to such additive or additive blend.
(e) Aftermarket Aerosol Additives. (1) To obtain registration for an aftermarket aerosol fuel additive, the manufacturer shall provide existing information in the form of a literature search, a discussion of the potential exposure(s) to such product, and the basic registration data specified in § 79.59(b).
(2) The literature search shall include existing data on potential health and welfare effects due to exposure to the aerosol product itself and its raw (uncombusted) components. The analysis for potential exposures shall be based on the actual or anticipated production volume and market distribution of the particular aerosol product, and its estimated frequency of use. Other Tier 1 and Tier 2 requirements are not routinely required for aerosol products. EPA will review the submitted information and, at EPA's discretion, may require from the manufacturer further information and/or testing under Tier 3 on a case-by-case basis.