§79.52. Tier 1. — 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) Manufacturers of fuels and fuel additives are allowed to satisfy the testing requirements in §§ 79.52, 79.53, and 79.54 and the associated reporting requirements in § 79.59 on an individual or group basis, provided that such products meet the criteria in this section for enrollment in the same fuel/additive group. However, each manufacturer of a fuel or fuel additive must individually comply with the notification requirements of § 79.59(b). Further, if a manufacturer elects to comply by participation in a group, each manufacturer continues to be individually subject to the information requirements of this subpart.

(1) No manufacturer is prohibited from testing and submitting its own data for its own product registration, despite its qualification for membership in a particular group.

(ii) For Tier 1 (§ 79.52), the total set of requirements for the characterization of combustion emissions (§ 79.52(b)) must be completed two times, once using emissions generated with the aftertreatment device intact and a second time with the aftertreatment device rendered nonfunctional or replaced with a non-functional aftertreatment device as described in paragraph (d)(2)(i)(B) of this section.

(a) Sellers of relabeled additives (pursuant to § 79.50) are not required to comply with the provisions of § 79.52, 79.53 or 79.59, except that such sellers are required to comply with § 79.59(b).

(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).

(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.

This section specifies the equipment and procedures that must be used in generating the emissions which are to be subjected to the characterization procedures and/or the biological tests specified in §§ 79.52(b) and 79.53 of these regulations. When applicable, they may also be required in conjunction with testing under §§ 79.54 and 79.58(c). Additional requirements concerning emission generation, delivery, dilution, quality control, and safety practices are outlined in § 79.61.

(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)(1)(i) and § 79.57(d)(2)(ii), emission generation and characterization must be repeated three times when the selected vehicle/engine is normally operated without an emissions aftertreatment device and six times when the selected vehicle/engine is normally operated with an emissions aftertreatment device. In the latter case, the emission generation and characterization process shall be repeated three times with the intact aftertreatment device in place and three times with a non-functioning (blank) aftertreatment device in place.

(A) Vapor phase emissions shall be collected and stored in Tedlar bags for subsequent chemical analysis. Storage conditions are specified in § 79.52(b)(2).

(ii) If unscheduled maintenance becomes necessary, the vehicle or engine must be repaired to OEM specifications, using OEM or OEM-approved parts. In addition, the tester is required to measure the basic emissions pursuant to § 79.52(b)(2)(i) after the unscheduled maintenance and before resuming testing to ensure that the post-maintenance emissions shall be within 20 percent of pre-maintenance emissions levels. If the basic emissions cannot be brought within 20 percent of their previous levels, then the manufacturer shall restart the emissions characterization and health testing of its products combustion emissions using a new vehicle/engine.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(g) Information on base fuel emission inventories may be found in references in paragraphs (b)(5)(i) through (xi) of this section, as well as in the following:

(2) Keith et al., ACS Committee on Environmental Improvement, “Principles of Environmental Analysis,” The Journal of Analytical Chemistry, Volume 55, pp. 2210-2218, 1983.

(3) “The Composition of Gasoline Engine Hydrocarbon Emissions—An Evaluation of Catalyst and Fuel Effects”—SAE 902074 and “Speciated Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model Fuels”—SAE 930373.

(1) All health and safety test data and other information concerning health and welfare effects which is submitted by any manufacturer or group pursuant to §§ 79.52(c), 79.53, or 79.54, shall be considered to be public information and shall be made available to the public by EPA upon request. A reasonable fee may be charged by EPA for copying such materials. Any manufacturer or group who claims that any information concerning the composition of a fuel or fuel additive product, or any other information, submitted under this subpart is confidential business information must state this claim in writing at the time of the submittal.

(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.

(b) Manufacturers shall determine whether the information gathered pursuant to the literature search in § 79.52(d) contains the results of adequately performed and adequately documented previous testing which provides information reasonably comparable to that supplied by the health tests described in §§ 79.62 through 79.68 regarding the carcinogenicity, mutagenicity, neurotoxicity, teratogenicity, reproductive/fertility measures, and general toxicity effects of the emissions of the fuel or additive. When manufacturers make an affirmative determination, they need submit only the information gathered pursuant to § 79.52(d) for such tests. EPA maintains final authority in judging whether the information is an adequate substitution in lieu of conducting the associated tests. EPA's determination of the adequacy of existing information shall be guided by the considerations described in paragraph (d) of this section. If EPA finds that the manufacturer has relied upon inadequate test data, then the manufacturer will not be considered to be in compliance until the corresponding tests have been conducted and the results submitted to EPA.

(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.