§79.59. Reporting requirements. — 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.

(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.

(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).

(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.

(vii) A manufacturer seeking registration for formulation(s) which do not fit the criteria for inclusion in any of the fuel families described in this section shall contact EPA at the address in § 79.59(a)(1) for further guidance in classifying and testing such formulation(s).

(B) When the test formulation does contain atypical elements, then the manufacturer may choose to accumulate the required mileage using a vehicle/engine equipped with either an intact aftertreatment device or with a non-functional aftertreatment device (e.g., a blank catalyst without its catalytic wash coat). In either case, sampling and analysis of emissions for measurement of the mass of the atypical element(s) (as described in § 79.57(c)(3)) must be done on emissions generated with a non-functional (blank) aftertreatment device.

(1) If the manufacturer chooses to accumulate mileage without a functional aftertreatment device, and if the manufacturer wishes to do this outside of a laboratory/test track setting, then a memorandum of exemption for product testing must be obtained by applying to the Director of the Field Operations and Support Division (see § 79.59(a)(1)).

(2) [Reserved]

(b) 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.

(f) The literature search shall cover a time period beginning at least thirty years prior to the date of submission of the reports specified in §§ 79.59(b) through (c) and ending no earlier than six months prior to the date on which testing is commenced or reports are submitted in compliance with this subpart.

(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.

(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).

(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.

(1) For purposes of these provisions, when subsidiary, divisional, or other complex business arrangements exist, manufacturer is defined as the business entity with ultimate ownership of all related parents, subsidiaries, divisions, branches, or other operating units. Total annual sales means the average of the manufacturer's total sales revenue, excluding any revenue which represents the collection of Federal, State, or local excise taxes or sales taxes, in each of the three years prior to such manufacturer's submittal to EPA of the basic registration information pursuant to § 79.59(b)(2) through (b)(5).

(1) For purposes of these provisions, when subsidiary, divisional, or other complex business arrangements exist, manufacturer is defined as the business entity with ultimate ownership of all related parents, subsidiaries, divisions, branches, or other operating units. Total annual sales means the average of the manufacturer's total sales revenue, excluding any revenue which represents the collection of Federal, State, or local excise taxes or sales taxes, in each of the three years prior to such manufacturer's submittal to EPA of the basic registration information pursuant to § 79.59(b)(2) through (b)(5).

(1) For purposes of these provisions, when subsidiary, divisional, or other complex business arrangements exist, manufacturer is defined as the business entity with ultimate ownership of all related parents, subsidiaries, divisions, branches, or other operating units. Total annual sales means the average of the manufacturer's total sales revenue, excluding any revenue which represents the collection of Federal, State, or local excise taxes or sales taxes, in each of the three years prior to such manufacturer's submittal to EPA of the basic registration information pursuant to § 79.59(b)(2) through (b)(5).

(c) In complying with the registration requirements for a given fuel or fuel additive, notwithstanding the enrollment of such fuel or additive in a group, a manufacturer may make use of available information for any product which conforms to the same grouping criteria as the given product. If, for this purpose, a manufacturer wishes to rely upon the information previously submitted by another manufacturer (or group of manufacturers) for registration of a similar product (or group of products), then the previous submitter is entitled to reimbursement by the manufacturer for an appropriate portion of the applicable costs incurred to obtain and report such information. Such entitlement shall remain in effect for a period of fifteen years following the date on which the original information was submitted. Pursuant to § 79.59(b)(4)(ii), the manufacturer who relies on previously-submitted registration data shall certify to EPA that the original submitter has been notified and that appropriate reimbursement arrangements have been made.

(1) When private efforts have failed to resolve a dispute about a fair amount or method of cost-sharing or reimbursement for testing costs incurred under this subpart, then any party involved in that dispute may initiate a hearing by filing two signed copies of a request for a hearing with a regional office of the American Arbitration Association and mailing a copy of the request to EPA. A copy must also be sent to each person from whom the filing party seeks reimbursement or who seeks reimbursement from that party. The information and fees to be included in the request for hearing are specified in 40 CFR 791.20(b) and (c).

(2) Additional procedures and requirements governing the hearing process are those specified in 40 CFR 791.22 through 791.50, 791.60, 791.85, and 791.105, excluding 40 CFR 791.39(a)(3) and 791.48(d).

(1) For purposes of these provisions, when subsidiary, divisional, or other complex business arrangements exist, manufacturer is defined as the business entity with ultimate ownership of all related parents, subsidiaries, divisions, branches, or other operating units. Total annual sales means the average of the manufacturer's total sales revenue, excluding any revenue which represents the collection of Federal, State, or local excise taxes or sales taxes, in each of the three years prior to such manufacturer's submittal to EPA of the basic registration information pursuant to § 79.59(b)(2) through (b)(5).

(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.

(f) The literature search shall cover a time period beginning at least thirty years prior to the date of submission of the reports specified in §§ 79.59(b) through (c) and ending no earlier than six months prior to the date on which testing is commenced or reports are submitted in compliance with this subpart.

(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.

(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).

(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).

(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).