Section 79.21 - Information and assurances to be provided by the additive manufacturerEach 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:(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 .40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59 FR 33093, June 27, 1994; 85 FR 78463, Dec. 4, 2020