Title 40
SECTION 79.51
79.51 General requirements and provisions.
§ 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.
(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.
[59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996; 62 FR 12575, Mar. 17, 1997; 85 FR 7069, Feb. 6, 2020]