§79.21. Information and assurances to be provided by the additive manufacturer. — Inbound Citations

(A) Regulation Title 6 of the New York Codes, Rules and Regulations (NYCRR), Part 217, “Motor Vehicle Enhanced Inspection and Maintenance Program Requirements,” specifically, Subpart 217-1, “Motor Vehicle Enhanced Inspection and Maintenance Program Requirements” and Subpart 217-4, “Inspection and Maintenance Program Audits,” effective on October 30, 2002, and the New York State Department of Motor Vehicles regulation Title 15 NYCRR Part 79 “Motor Vehicle Inspection Regulations,” specifically, Sections 79.1-79.15, 79.17, 79.20, 79.21, 79.24, and 79.25, effective on May 4, 2005.

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.

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.

(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.

(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.

(1) The information specified in § 79.11 or § 79.21. If such information has already been submitted to EPA in compliance with subpart B or C of this part, and if such previous information is accurate and up-to-date, the manufacturer need not resubmit this information.

(2) The gasoline detergent manufacturer must cease selling a detergent immediately upon being notified by CARB that the CARB certification for this detergent has been invalidated and must notify EPA under 40 CFR 79.21.

(i) A gasoline detergent manufacturer must register gasoline detergent(s) under 40 CFR 79.21 at a concentration that is greater than or equal to the LAC reported by the gasoline detergent manufacturer under 40 CFR 79.21(j). Note: EPA provides a list on EPA's website of detergents that have been certified by the gasoline detergent manufacturer as meeting the deposit control requirement (Search for “List of Certified Detergent Additives”).

(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.

(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.

(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.

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.

(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.

(i) A gasoline detergent manufacturer must register gasoline detergent(s) under 40 CFR 79.21 at a concentration that is greater than or equal to the LAC reported by the gasoline detergent manufacturer under 40 CFR 79.21(j). Note: EPA provides a list on EPA's website of detergents that have been certified by the gasoline detergent manufacturer as meeting the deposit control requirement (Search for “List of Certified Detergent Additives”).

(3) A gasoline detergent manufacturer must produce detergents consistent with their detergent certifications for detergents certified prior to January 1, 2021, and with the specific composition information submitted as part of the registration of detergents under 40 CFR 79.21(j) thereafter.

(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.

(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.

(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.