§79.51. General requirements and provisions. — Inbound Citations

(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.

(a) 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.

(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.

(2) The information specified in paragraph (c) of this section shall be submitted to the address in paragraph (a)(1) of this section at the conclusion of activities performed in compliance with Tiers 1 and 2 under the provisions of §§ 79.52 and 79.53, according to the time constraints specified in § 79.51 (c) through (d).

(i) For existing products (pursuant to § 79.51(c)(1)), manufacturers shall submit the basic registration data as specified in § 79.59(b) to EPA by November 28, 1994.

(c) If the results of Tiers 1 and 2 are reported to EPA at the same time, then the report shall include the following documents in paragraphs (c)(1) through (7) of this section. If Tier 1 and Tier 2 results are submitted to EPA separately, then the separate Tier 1 report shall include only documents in paragraphs (c) (1) through (4), (c)(6), and associated appendices in paragraphs (c)(7) of this section, and the separate Tier 2 report shall include only documents in paragraphs (c)(1) through (3), (c)(5), (c)(6), and associated appendices in paragrpah (c)(7) of this section. In addition, manufacturers complying with Tier 2 requirements according to one of the time schedules specified in § 79.51(c)(1)(ii)(B), § 79.51(c)(1)(vi)(B)(2), or § 79.51(c)(1)(vii)(B)(2) must submit evidence of a suitable arrangement for completion of Tier 2 (e.g., a copy of a signed contract with a qualified laboratory for applicable Tier 2 services) by the date specified in the applicable time schedule.

(i) Identification of test substance,

(ii) Name and address of the manufacturer of the test substance,

(iii) Name and phone number of a designated contact person,

(A) Group name or grouping criteria,

(B) Name and address of responsible organization or entity reporting for the group,

(2) Text overview of the significant results and conclusions obtained as a result of completing the requirements of Tier 1 and/or Tier 2, including references if used to support such results and conclusions.

(3) Test substance description, including, as applicable,

(i) Base fuel parameter values (including types and concentrations of base fuel additives) or test fuel composition (if a fuel other than the base fuel is used in testing). These values must be provided for each of the fuel parameters specified in § 79.55 for the applicable fuel family.

(ii) Test additive composition and concentration

(i) Pursuant to § 79.52(d), the literature search shall include a text summary of the methods and results of the literature search, including the following:

(A) Identification of person(s) performing the literature search,

(B) Description of data sources accessed, search strategy used, search period, and terms included in literature search,

(C) Documentation of all unpublished in-house and other privately-conducted studies,

(D) Tables summarizing the protocols and results of all cited studies,

(E) Summary of significant results and conclusions with respect to the effects of the emissions of the subject fuel or fuel additive on the public health and welfare, including references if used to support such results and conclusions.

(F) Statement of the extent to which the literature search has produced adequate information comparable to that which would otherwise be obtained through the performance of applicable emission characterization requirements under § 79.52(b) and/or health effects testing requirements under § 79.53, including justifications and specific references.

(ii) Pursuant to § 79.52(b), the emission characterization shall include:

(A) Name, address, and telephone number of the laboratory performing the characterization,

(5) For each health effects test performed pursuant to the provisions of § 79.53, the Tier 2 summary shall contain the following information:

(i) Name, address, and telephone number of the testing facility,

(ii) Summary of procedures (including quality assurance, quality control and compliance with Good Laboratory Practice Standards as specified in § 79.60), findings, and conclusions, including references if used to support such results and conclusions,

(6) The conclusions shall identify the need for further testing, if that need exists, or justify that current testing and/or available information is adequate for the tier(s) included in the report.

(7) The appendices shall contain detailed documentation related to the summary information described in this section, including, at a minimum, the following five appendices:

(i) Literature search appendices shall contain:

(A) Copies of literature source outputs, including reference lists and associated abstracts from database searches, printed or on 3 1/2 inch IBM-compatible computer diskettes;

(B) Summary tables organized by health or welfare endpoint and type of emission (e.g., combustion, evaporation, individual emission product), presenting in tabular form the following information at a minimum: number and species of test subjects, exposure concentrations/duration, positive (i.e., abnormal) findings including numbers of test subjects involved, and bibliographic references;

(C) Complete documentation and/or reprints of articles for any previous study relied upon for satisfying emission characterization and/or Tier 2 test requirements; and

(ii) Emissions characterization appendices shall contain:

(A) Complete laboratory reports, including documentation of calibration and verification procedures;

(B) Documentation of the emissions generation procedures used; and

(iii) [Reserved]

(iv) Tier 2 appendices shall contain, for each test performed:

(A) Complete protocol used;

(B) Documentation of emission generation procedures; and

(C) Complete laboratory report in compliance with the reporting standards in § 79.60, including detailed test results and conclusions, and descriptions of any problems encountered and their resolution.

(v) Laboratory certification/accreditation information, personnel credentials, and statements of compliance with the Good Laboratory Practices Standards specified in § 79.60 and the requirements in § 79.53(c)(1).

(c) If the results of Tiers 1 and 2 are reported to EPA at the same time, then the report shall include the following documents in paragraphs (c)(1) through (7) of this section. If Tier 1 and Tier 2 results are submitted to EPA separately, then the separate Tier 1 report shall include only documents in paragraphs (c) (1) through (4), (c)(6), and associated appendices in paragraphs (c)(7) of this section, and the separate Tier 2 report shall include only documents in paragraphs (c)(1) through (3), (c)(5), (c)(6), and associated appendices in paragrpah (c)(7) of this section. In addition, manufacturers complying with Tier 2 requirements according to one of the time schedules specified in § 79.51(c)(1)(ii)(B), § 79.51(c)(1)(vi)(B)(2), or § 79.51(c)(1)(vii)(B)(2) must submit evidence of a suitable arrangement for completion of Tier 2 (e.g., a copy of a signed contract with a qualified laboratory for applicable Tier 2 services) by the date specified in the applicable time schedule.

(i) Identification of test substance,

(ii) Name and address of the manufacturer of the test substance,

(iii) Name and phone number of a designated contact person,

(A) Group name or grouping criteria,

(B) Name and address of responsible organization or entity reporting for the group,

(2) Text overview of the significant results and conclusions obtained as a result of completing the requirements of Tier 1 and/or Tier 2, including references if used to support such results and conclusions.

(3) Test substance description, including, as applicable,

(i) Base fuel parameter values (including types and concentrations of base fuel additives) or test fuel composition (if a fuel other than the base fuel is used in testing). These values must be provided for each of the fuel parameters specified in § 79.55 for the applicable fuel family.

(ii) Test additive composition and concentration

(i) Pursuant to § 79.52(d), the literature search shall include a text summary of the methods and results of the literature search, including the following:

(A) Identification of person(s) performing the literature search,

(B) Description of data sources accessed, search strategy used, search period, and terms included in literature search,

(C) Documentation of all unpublished in-house and other privately-conducted studies,

(D) Tables summarizing the protocols and results of all cited studies,

(E) Summary of significant results and conclusions with respect to the effects of the emissions of the subject fuel or fuel additive on the public health and welfare, including references if used to support such results and conclusions.

(F) Statement of the extent to which the literature search has produced adequate information comparable to that which would otherwise be obtained through the performance of applicable emission characterization requirements under § 79.52(b) and/or health effects testing requirements under § 79.53, including justifications and specific references.

(ii) Pursuant to § 79.52(b), the emission characterization shall include:

(A) Name, address, and telephone number of the laboratory performing the characterization,

(5) For each health effects test performed pursuant to the provisions of § 79.53, the Tier 2 summary shall contain the following information:

(i) Name, address, and telephone number of the testing facility,

(ii) Summary of procedures (including quality assurance, quality control and compliance with Good Laboratory Practice Standards as specified in § 79.60), findings, and conclusions, including references if used to support such results and conclusions,

(6) The conclusions shall identify the need for further testing, if that need exists, or justify that current testing and/or available information is adequate for the tier(s) included in the report.

(7) The appendices shall contain detailed documentation related to the summary information described in this section, including, at a minimum, the following five appendices:

(i) Literature search appendices shall contain:

(A) Copies of literature source outputs, including reference lists and associated abstracts from database searches, printed or on 3 1/2 inch IBM-compatible computer diskettes;

(B) Summary tables organized by health or welfare endpoint and type of emission (e.g., combustion, evaporation, individual emission product), presenting in tabular form the following information at a minimum: number and species of test subjects, exposure concentrations/duration, positive (i.e., abnormal) findings including numbers of test subjects involved, and bibliographic references;

(C) Complete documentation and/or reprints of articles for any previous study relied upon for satisfying emission characterization and/or Tier 2 test requirements; and

(ii) Emissions characterization appendices shall contain:

(A) Complete laboratory reports, including documentation of calibration and verification procedures;

(B) Documentation of the emissions generation procedures used; and

(iii) [Reserved]

(iv) Tier 2 appendices shall contain, for each test performed:

(A) Complete protocol used;

(B) Documentation of emission generation procedures; and

(C) Complete laboratory report in compliance with the reporting standards in § 79.60, including detailed test results and conclusions, and descriptions of any problems encountered and their resolution.

(v) Laboratory certification/accreditation information, personnel credentials, and statements of compliance with the Good Laboratory Practices Standards specified in § 79.60 and the requirements in § 79.53(c)(1).

(c) If the results of Tiers 1 and 2 are reported to EPA at the same time, then the report shall include the following documents in paragraphs (c)(1) through (7) of this section. If Tier 1 and Tier 2 results are submitted to EPA separately, then the separate Tier 1 report shall include only documents in paragraphs (c) (1) through (4), (c)(6), and associated appendices in paragraphs (c)(7) of this section, and the separate Tier 2 report shall include only documents in paragraphs (c)(1) through (3), (c)(5), (c)(6), and associated appendices in paragrpah (c)(7) of this section. In addition, manufacturers complying with Tier 2 requirements according to one of the time schedules specified in § 79.51(c)(1)(ii)(B), § 79.51(c)(1)(vi)(B)(2), or § 79.51(c)(1)(vii)(B)(2) must submit evidence of a suitable arrangement for completion of Tier 2 (e.g., a copy of a signed contract with a qualified laboratory for applicable Tier 2 services) by the date specified in the applicable time schedule.

(i) Identification of test substance,

(ii) Name and address of the manufacturer of the test substance,

(iii) Name and phone number of a designated contact person,

(A) Group name or grouping criteria,

(B) Name and address of responsible organization or entity reporting for the group,

(2) Text overview of the significant results and conclusions obtained as a result of completing the requirements of Tier 1 and/or Tier 2, including references if used to support such results and conclusions.

(3) Test substance description, including, as applicable,

(i) Base fuel parameter values (including types and concentrations of base fuel additives) or test fuel composition (if a fuel other than the base fuel is used in testing). These values must be provided for each of the fuel parameters specified in § 79.55 for the applicable fuel family.

(ii) Test additive composition and concentration

(i) Pursuant to § 79.52(d), the literature search shall include a text summary of the methods and results of the literature search, including the following:

(A) Identification of person(s) performing the literature search,

(B) Description of data sources accessed, search strategy used, search period, and terms included in literature search,

(C) Documentation of all unpublished in-house and other privately-conducted studies,

(D) Tables summarizing the protocols and results of all cited studies,

(E) Summary of significant results and conclusions with respect to the effects of the emissions of the subject fuel or fuel additive on the public health and welfare, including references if used to support such results and conclusions.

(F) Statement of the extent to which the literature search has produced adequate information comparable to that which would otherwise be obtained through the performance of applicable emission characterization requirements under § 79.52(b) and/or health effects testing requirements under § 79.53, including justifications and specific references.

(ii) Pursuant to § 79.52(b), the emission characterization shall include:

(A) Name, address, and telephone number of the laboratory performing the characterization,

(5) For each health effects test performed pursuant to the provisions of § 79.53, the Tier 2 summary shall contain the following information:

(i) Name, address, and telephone number of the testing facility,

(ii) Summary of procedures (including quality assurance, quality control and compliance with Good Laboratory Practice Standards as specified in § 79.60), findings, and conclusions, including references if used to support such results and conclusions,

(6) The conclusions shall identify the need for further testing, if that need exists, or justify that current testing and/or available information is adequate for the tier(s) included in the report.

(7) The appendices shall contain detailed documentation related to the summary information described in this section, including, at a minimum, the following five appendices:

(i) Literature search appendices shall contain:

(A) Copies of literature source outputs, including reference lists and associated abstracts from database searches, printed or on 3 1/2 inch IBM-compatible computer diskettes;

(B) Summary tables organized by health or welfare endpoint and type of emission (e.g., combustion, evaporation, individual emission product), presenting in tabular form the following information at a minimum: number and species of test subjects, exposure concentrations/duration, positive (i.e., abnormal) findings including numbers of test subjects involved, and bibliographic references;

(C) Complete documentation and/or reprints of articles for any previous study relied upon for satisfying emission characterization and/or Tier 2 test requirements; and

(ii) Emissions characterization appendices shall contain:

(A) Complete laboratory reports, including documentation of calibration and verification procedures;

(B) Documentation of the emissions generation procedures used; and

(iii) [Reserved]

(iv) Tier 2 appendices shall contain, for each test performed:

(A) Complete protocol used;

(B) Documentation of emission generation procedures; and

(C) Complete laboratory report in compliance with the reporting standards in § 79.60, including detailed test results and conclusions, and descriptions of any problems encountered and their resolution.

(v) Laboratory certification/accreditation information, personnel credentials, and statements of compliance with the Good Laboratory Practices Standards specified in § 79.60 and the requirements in § 79.53(c)(1).

(ii) For registrable products (pursuant to § 79.51(c)(2)), manufacturers shall submit the basic registration data as specified in § 79.59(b) to apply for registration for such product.

(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.

(iii) For new products (pursuant to § 79.51(c)(3)), manufacturers are strongly encouraged to notify EPA of an intent to obtain product registration by submitting the basic registration data as specified in § 79.59(b) prior to starting Tiers 1 and 2.

(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.

(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.

(2) The information specified in paragraph (c) of this section shall be submitted to the address in paragraph (a)(1) of this section at the conclusion of activities performed in compliance with Tiers 1 and 2 under the provisions of §§ 79.52 and 79.53, according to the time constraints specified in § 79.51 (c) through (d).

(c) 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:

(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.

(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) 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.

(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).

(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).

(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.

(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).

(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.

(A) 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) (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.