[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2024 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 40
Protection of Environment
________________________
Parts 79 to 80
Revised as of July 1, 2024
Containing a codification of documents of general
applicability and future effect
As of July 1, 2024
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
As of July 1, 2024
Title 40, Part 80
Revised as of July 1, 2023
Is Replaced by
Title 40, Parts 79 to 80
[[Page v]]
Table of Contents
Page
Explanation................................................. vii
Title 40:
Chapter I--Environmental Protection Agency
(Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 269
Alphabetical List of Agencies Appearing in the CFR...... 289
List of CFR Sections Affected........................... 299
[[Page vi]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 40 CFR 79.1 refers
to title 40, part 79,
section 1.
----------------------------
[[Page vii]]
EXPLANATION
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[[Page viii]]
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[[Page ix]]
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Oliver A. Potts,
Director,
Office of the Federal Register
July 1, 2024
[[Page xi]]
THIS TITLE
Title 40--Protection of Environment is composed of thirty-seven
volumes. The parts in these volumes are arranged in the following order:
Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-
52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-
60.499), part 60 (60.500-end of part 60, sections), part 60
(Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-
63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63
(63.6580-63.8830), part 63 (63.8980-end of part 63), parts 64-71, parts
72-78, parts 79-80, part 81, parts 82-84, parts 85-96, parts 97-99,
parts 100-135, parts 136-149, parts 150-189, parts 190-259, parts 260-
265, parts 266-299, parts 300-399, parts 400-424, parts 425-699, parts
700-722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to
end. The contents of these volumes represent all current regulations
codified under this title of the CFR as of July 1, 2024.
Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. OMB control numbers for title 40 appear in Sec. 9.1 of
this chapter.
Chapters IV-IX--Regulations issued by the Environmental Protection
Agency and Department of Justice, Council on Environmental Quality,
Chemical Safety and Hazard Investigation Board, Environmental Protection
Agency and Department of Defense; Uniform National Discharge Standards
for Vessels of the Armed Forces, Gulf Coast Ecosystem Restoration
Council, and the Federal Permitting Improvement Steering Council appear
in volume thirty-seven.
For this volume, Gabrielle E. Burns was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 40--PROTECTION OF ENVIRONMENT
(This book contains parts 79 to 80)
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Part
chapter i--Environmental Protection Agency (Continued)...... 79
[[Page 3]]
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
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Editorial Note: Nomenclature changes to chapter I appear at 65 FR
47324, 47325, Aug. 2, 2000; 66 FR 34375, 34376, June 28, 2001; and 69 FR
18803, Apr. 9, 2004.
SUBCHAPTER C--AIR PROGRAMS (CONTINUED)
Part Page
79 Registration of fuels and fuel additives.... 5
80 Regulation of fuels and fuel additives...... 102
[[Page 5]]
SUBCHAPTER C_AIR PROGRAMS (CONTINUED)
PART 79_REGISTRATION OF FUELS AND FUEL ADDITIVES--Table of Contents
Subpart A_General Provisions
Sec.
79.1 Applicability.
79.2 Definitions.
79.3 Availability of information.
79.4 Requirement of registration.
79.5 Periodic reporting requirements.
79.6 Requirement for testing.
79.7 Samples for test purposes.
79.8 Penalties.
Subpart B_Fuel Registration Procedures
79.10 Application for registration by fuel manufacturer.
79.11 Information and assurances to be provided by the fuel
manufacturer.
79.12 Determination of noncompliance.
79.13 Registration.
79.14 Termination of registration of fuels.
Subpart C_Additive Registration Procedures
79.20 Application for registration by additive manufacturer.
79.21 Information and assurances to be provided by the additive
manufacturer.
79.22 Determination of noncompliance.
79.23 Registration.
79.24 Termination of registration of additives.
Subpart D_Designation of Fuels and Additives
79.30 Scope.
79.31 Additives.
79.32 Motor vehicle gasoline.
79.33 Motor vehicle diesel fuel.
Subpart E [Reserved]
Subpart F_Testing Requirements for Registration
79.50 Definitions.
79.51 General requirements and provisions.
79.52 Tier 1.
79.53 Tier 2.
79.54 Tier 3.
79.55 Base fuel specifications.
79.56 Fuel and fuel additive grouping system.
79.57 Emission generation.
79.58 Special provisions.
79.59 Reporting requirements.
79.60 Good laboratory practices (GLP) standards for inhalation exposure
health effects testing.
79.61 Vehicle emissions inhalation exposure guideline.
79.62 Subchronic toxicity study with specific health effect assessments.
79.63 Fertility assessment/teratology.
79.64 In vivo micronucleus assay.
79.65 In vivo sister chromatid exchange assay.
79.66 Neuropathology assessment.
79.67 Glial fibrillary acidic protein assay.
79.68 Salmonella typhimurium reverse mutation assay.
Authority: 42 U.S.C. 7414, 7524, 7545 and 7601.
Source: 40 FR 52011, Nov. 7, 1975, unless otherwise noted.
Subpart A_General Provisions
Sec. 79.1 Applicability.
The regulations of this part apply to the registration of fuels and
fuel additives designated by the Administrator, pursuant to section 211
of the Clean Air Act (42 U.S.C. 1857f-6c, as amended by section 9, Pub.
L. 91-604).
Sec. 79.2 Definitions.
As used in this part, all terms not defined herein shall have the
meaning given them in the Act:
(a) Act means the Clean Air Act (42 U.S.C. 1857 et seq., as amended
by Pub. L. 91-604).
(b) Administrator means the Administrator of the Environmental
Protection Agency.
(c) Fuel means any material which is capable of releasing energy or
power by combustion or other chemical or physical reaction.
(d) Fuel manufacturer means any person who, for sale or introduction
into commerce, produces, manufactures, or imports a fuel or causes or
directs the alteration of the chemical composition of a bulk fuel, or
the mixture of chemical compounds in a bulk fuel, by adding to it an
additive, except:
(1) A party (other than a fuel refiner or importer) who adds a
quantity of additive(s) amounting to less than 1.0
[[Page 6]]
percent by volume of the resultant additive(s)/fuel mixture is not
thereby considered a fuel manufacturer.
(2) A party (other than a fuel refiner or importer) who adds an
oxygenate compound to fuel in any otherwise allowable amount is not
thereby considered a fuel manufacturer.
(e) Additive means any substance, other than one composed solely of
carbon and/or hydrogen, that is intentionally added to a fuel named in
the designation (including any added to a motor vehicle's fuel system)
and that is not intentionally removed prior to sale or use.
(f) Additive manufacturer means any person who produces,
manufactures, or imports an additive for use as an additive and/or sells
or imports for sale such additive under the person's own name.
(g) Range of concentration means the highest concentration, the
lowest concentration, and the average concentration of an additive in a
fuel.
(h) Chemical composition means the name and percentage by weight of
each compound in an additive and the name and percentage by weight of
each element in an additive.
(i) Chemical structure means the molecular structure of a compound
in an additive.
(j) Impurity means any chemical element present in an additive that
is not included in the chemical formula or identified in the breakdown
by element in the chemical composition of such additive.
(k) Oxygenate compound means an oxygen-containing, ashless organic
compound, such as an alcohol or ether, which may be used as a fuel or
fuel additive.
[40 FR 52011, Nov. 7, 1975, as amended at 59 FR 33092, June 27, 1994; 62
FR 12571, Mar. 17, 1997]
Sec. 79.3 Availability of information.
The availability to the public of information provided to, or
otherwise obtained by, the Administrator under this part shall be
governed by part 2 of this chapter except as expressly noted in subpart
F of this part.
[59 FR 33092, June 27, 1994]
Sec. 79.4 Requirement of registration.
(a) Fuels. (1) No manufacturer of any fuel designated under this
part shall, after the date prescribed for such fuel in this part, sell,
offer for sale, or introduce into commerce such fuel unless the
Administrator has registered such fuel.
(2) No manufacturer of a registered fuel shall add or direct the
addition to it of an additive which he has not previously reported
unless he has notified the Administrator of such intended use, including
the expected or estimated range of concentration. If necessary to meet
an unforeseen production problem, however, a fuel manufacturer may use
an additive that he has not previously reported provided that (i) the
additive is on the current list of registered additives and (ii) the
fuel manufacturer notifies the Administrator within 30 days regarding
such unforeseen use and his plans regarding continued use, including the
expected or estimated range of concentration.
(3) Any designated fuel that is (i) in a research, development, or
test status; (ii) sold to automobile, engine, or component manufacturers
for research, development, or test purposes; or (iii) sold to automobile
manufacturers for factory fill, and is not in any case offered for
commercial sale to the public, shall be exempt from registration.
(4) A domestic fuel manufacturer may purchase and offer for
commercial sale foreign-produced fuel containing unidentified additives
provided that within 30 days of his offer for sale he notifies the
Administrator of the purchase, the source of purchase, the quantity
purchased, and summarized results of any tests performed to determine
the acceptability of the purchased fuel to the fuel manufacturer.
(b) Additives. (1) No manufacturer of any fuel additive designated
under this part shall, after the date by which the additive must be
registered under this part, sell, offer for sale, or introduce into
commerce such additive for use in any type of fuel designated under this
part unless the Administrator has registered that additive for use in
that type of fuel.
(2) Any designated additive that is either (i) in a research,
development, or test status or (ii) sold to petroleum,
[[Page 7]]
automobile, engine, or component manufacturers for research,
development, or test purposes, and in either case is not offered for
commercial sale to the public, shall be exempt from registration.
(3) Process chemicals used by refineries during the refinery process
are exempted from the requirement for registration.
(4) If an additive manufacturer prepares for sale only to fuel
manufacturers (i) a blend or mixture of two or more registered additives
or (ii) a blend or mixture of one or more registered additives with one
or more substances containing only carbon and/or hydrogen, he will not
be required to register such blend or mixture provided he will, upon
request, furnish the Administrator with the names and percentages by
weight of all components of such blend or mixture.
[40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59
FR 33092, June 27, 1994]
Sec. 79.5 Periodic reporting requirements.
(a) Fuel manufacturers. (1) For each calendar year (January 1
through December 31) commencing after the date prescribed for any fuel
in subpart D of this part, fuel manufacturers must submit to the
Administrator a report for each registered fuel showing the range of
concentration of each additive reported under Sec. 79.11(a) and the
volume of such fuel produced in the year. Reports must be submitted by
March 31 for the preceding year, or part thereof, on forms supplied by
the Administrator. If the date prescribed for a particular fuel in
subpart D of this part, or the later registration of a fuel is between
October 1 and December 31, no report will be required for the period to
the end of that year.
Table 1 to Sec. 79.5--Quarterly Reporting Deadlines
----------------------------------------------------------------------------------------------------------------
Calendar quarter Time period covered Quartely report deadline
----------------------------------------------------------------------------------------------------------------
Quarter 1........................... January 1-March 31.............. June 1.
Quarter 2........................... April 1-June 30................. September 1.
Quarter 3........................... July 1-September 30............. December 1.
Quarter 4........................... October 1-December 31........... March 31.
----------------------------------------------------------------------------------------------------------------
(2) Fuel manufacturers shall submit to the Administrator a report
annually for each registered fuel providing additional data and
information as specified in Sec. Sec. 79.32(c) and (d) and 79.33(c) and
(d) in the designation of the fuel in subpart D of this part. Reports
shall be submitted by March 31 for the preceding year, or part thereof,
on forms supplied by the Administrator upon request. If the date
prescribed for a particular fuel in subpart D of this part, or the later
registration of a fuel is between October 1 and December 31, no report
will be required for the period to the end of that year.
(b) Additive manufacturers. Additive manufacturers shall submit to
the Administrator a report annually for each registered additive
providing additional data and information as specified in Sec. 79.31(c)
and (d) in the designation of the additive in subpart D of this part.
Additive manufacturers shall also report annually the volume of each
additive produced. Reports shall be submitted by March 31 for the
preceding year, or part thereof, on forms supplied by the Administrator
upon request. If the date prescribed for a particular additive in
subpart D of this part, or the later registration of an additive is
between October 1 and December 31, no report will be required for the
period to the end of that year. These periodic reports shall not,
however, be required for any additive that is:
(1) An additive registered under another name,
(2) A blend or mixture of two or more registered additives, or
(3) A blend or mixture of one or more registered additives with one
or more
[[Page 8]]
substances containing only carbon and/or hydrogen.
[40 FR 52011, Nov. 7, 1975, as amended at 79 FR 23630, Apr. 28, 2014; 85
FR 78463, Dec. 4, 2020]
Sec. 79.6 Requirement for testing.
Provisions regarding testing that is required for registration of a
designated fuel or fuel additive are contained in subpart F of this
part.
[59 FR 33092, June 27, 1994]
Sec. 79.7 Samples for test purposes.
When the Administrator requires for test purposes a fuel or additive
which is not readily available in the open market, he may request the
manufacturer of such fuel or additive to furnish a sample in a
reasonable quantity. The fuel or additive manufacturer shall comply with
such request within 30 days.
Sec. 79.8 Penalties.
Any person who violates section 211(a) of the Act or who fails to
furnish any information or conduct any tests required under this part
shall be liable to the United States for a civil penalty of not more
than the sum of $25,000 for every day of such violation and the amount
of economic benefit or savings resulting from the violation. Civil
penalties shall be assessed in accordance with paragraphs (b) and (c) of
section 205 of the Act.
[58 FR 65554, Dec. 15, 1993]
Subpart B_Fuel Registration Procedures
Sec. 79.10 Application for registration by fuel manufacturer.
Any manufacturer of a designated fuel who wishes to register that
fuel shall submit an application for registration including all of the
information set forth in Sec. 79.11. If the manufacturer produces more
than one grade or brand of a designated fuel, a manufacturer may include
more than one grade or brand in a single application, provided that the
application includes all information required for registration of each
such grade or brand by this part. Each application shall be signed by
the fuel manufacturer and shall be submitted on such forms as the
Administrator will supply on request.
[59 FR 33092, June 27, 1994]
Sec. 79.11 Information and assurances to be provided by the fuel
manufacturer.
Each application for registration submitted by the manufacturer of a
designated fuel shall include the following:
(a) The commercial identifying name of each additive that will or
may be used in a designated fuel subsequent to the date prescribed for
such fuel in subpart D;
(b) The name of the additive manufacturer of each additive named;
(c) The range of concentration of each additive named, as follows:
(1) In the case of an additive which has been or is being used in
the designated fuel, the range during any 3-month or longer period prior
to the date of submission;
(2) In the case of an additive which has not been used in the
designated fuel, the expected or estimated range;
(d) The purpose-in-use of each additive named;
(e) The description (or identification, in the case of a generally
accepted method) of a suitable analytical technique (if one is known)
that can be used to detect the presence of each named additive in the
designated fuel and/or to measure its concentration therein;
(f) Such other data and information as are specified in the
designation of the fuel in subpart D;
(g) Assurances that the fuel manufacturer will notify the
Administrator in writing and within a reasonable time of any change in:
(1) The name of any additive previously reported;
(2) The name of the manufacturer of any additive being used;
(3) The purpose-in-use of any additive;
(4) Information submitted pursuant to paragraph (e) of this section;
(h) Assurances that the fuel manufacturer will not represent,
directly or indirectly, in any notice, circular, letter, or other
written communication, or any written, oral, or pictorial notice or
[[Page 9]]
other announcement in any publication or by radio or television, that
registration of the fuel constitutes endorsement, certification, or
approval by any agency of the United States;
(i) The manufacturer of any fuel which will be sold, offered for
sale, or introduced into commerce for use in motor vehicles manufactured
after model year 1974 shall demonstrate that the fuel is substantially
similar to any fuel utilized in the certification of any 1975 or
subsequent model year vehicle or engine, or that the manufacturer has
obtained a waiver under 42 U.S.C. 7545(f)(4); and
(j) The manufacturer shall submit, or shall reference prior
submissions, including all of the test data and other information
required prior to registration of the fuel by the provisions of subpart
F of this part.
[40 FR 52011, Nov. 7, 1975, as amended at 59 FR 33092, June 27, 1994]
Sec. 79.12 Determination of noncompliance.
If the Administrator determines that an applicant for registration
of a designated fuel has failed to submit all of the information
required by Sec. 79.11, or determines within the applicable period
provided for Agency review that the applicant has not satisfactorily
completed any testing which is required prior to registration of the
fuel by any provision of subpart F of this part, he shall return the
application to the manufacturer, along with an explanation of all
deficiencies in the required information.
[59 FR 33093, June 27, 1994]
Sec. 79.13 Registration.
(a) If the Administrator determines that a manufacturer has
submitted an application for registration of a designated fuel which
includes all of the information and assurances required by Sec. 79.11
and has satisfactorily completed all of the testing required by subpart
F of this part, the Administrator shall promptly register the fuel and
notify the fuel manufacturer of such registration.
(b) The Administrator shall maintain a list of registered fuels,
which shall be available to the public upon request.
[40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59
FR 33093, June 27, 1994]
Sec. 79.14 Termination of registration of fuels.
Registration may be terminated by the Administrator if the fuel
manufacturer requests such termination in writing.
Subpart C_Additive Registration Procedures
Sec. 79.20 Application for registration by additive manufacturer.
Any manufacturer of a designated fuel additive who wishes to
register that additive shall submit an application for registration
including all of the information set forth in Sec. 79.21. Each
application shall be signed by the fuel additive manufacturer and shall
be submitted on such forms as the Administrator will supply on request.
[59 FR 33093, June 27, 1994]
Sec. 79.21 Information and assurances to be provided by the additive
manufacturer.
Each application for registration submitted by the manufacturer of a
designated fuel additive shall include the following:
(a) The chemical composition of the additive with the methods of
analysis identified, except that
(1) If the chemical composition is not known, full disclosure of the
chemical process of manufacture will be accepted in lieu thereof;
(2) In the case of an additive for engine oil, only the name,
percentage by weight, and method of analysis of each element in the
additive are required provided, however, that a percentage figure
combining the percentages of carbon, hydrogen, and/or oxygen may be
provided unless the breakdown into percentages for these individual
elements is already known to the registrant.
(3) In the case of a purchased component, only the name,
manufacturer,
[[Page 10]]
and percent by weight of such purchased component are required if the
manufacturer of the component will, upon request, furnish the
Administrator with the chemical composition thereof.
(b) The chemical structure of each compound in the additive if such
structure is known and is not adequately specified by the name given
under ``chemical composition.'' Nominal identification is adequate if
mixed isomers are present.
(c) The description (or identification, in the case of a generally
accepted method) of a suitable analytical technique (if one is known)
that can be used to detect the presence of the additive in any fuel
named in the designation and/or to measure its concentration therein.
(d) The specific types of fuels designated under Sec. 79.32 for
which the fuel additive will be sold, offered for sale, or introduced
into commerce, and the fuel additive manufacturer's recommended range of
concentration and purpose-in-use for each such type of fuel.
(e) Such other data and information as are specified in the
designation of the additive in subpart D.
(f) Assurances that any change in information submitted pursuant to:
(1) Paragraphs (a), (b), (c), (d), and (j) of this section will be
provided to the Administrator in writing within 30 days of such change;
and
(2) Paragraph (e) of this section as provided in Sec. 79.5(b).
(g)(1) Assurances that the additive manufacturer will not represent,
directly or indirectly, in any notice, circular, letter, or other
written communication or any written, oral, or pictorial notice or other
announcement in any publication or by radio or television, that
registration of the additive constitutes endorsement, certification, or
approval by any agency of the United States, except as specified in
paragraph (g)(2) of this section.
(2) In the case of an additive that has its purpose-in-use
identified as a deposit control additive for use in gasoline pursuant to
the requirements of paragraph (d) of this section, the additive
manufacturer may publicly represent that the additive meets the EPA's
gasoline deposit control requirements, provided that the additive
manufacturer is in compliance with the requirements of 40 CFR 1090.260.
(h) The manufacturer of any fuel additive which will be sold,
offered for sale, or introduced into commerce for use in any type of
fuel intended for use in motor vehicles manufactured after model year
1974 shall demonstrate that the fuel additive, when used at the
recommended range of concentration, is substantially similar to any fuel
additive included in a fuel utilized in the certification of any 1975 or
subsequent model year vehicle or engine, or that the manufacturer has
obtained a waiver under 42 U.S.C. 7545(f)(4).
(i) The manufacturer shall submit, or shall reference prior
submissions, including all of the test data and other information
required prior to registration of the fuel additive by the provisions of
subpart F of this part.
(j) If the purpose-in-use of the additive identified pursuant to the
requirements of paragraph (d) of this section is a deposit control
additive for use in gasoline, the manufacturer must submit the following
in addition to the other information specified in this section:
(1) The lowest additive concentration (LAC) that is compliant with
the gasoline deposit control requirements of 40 CFR 1090.260.
(2) The deposit control test method in 40 CFR 1090.1395 that the
additive is compliant with.
(3) A complete listing of the additive's components and the weight
or volume percent (as applicable) of each component.
(i) Nomenclature. When possible, standard chemical nomenclature must
be used or the chemical structure of the component must be given.
Polymeric components may be reported as the product of other chemical
reactants, provided that the supporting data specified in paragraph
(j)(3) of this section is also reported.
(ii) Designation. Each detergent-active component of the package
must be classified into one of the following designations:
(A) Polyalkyl amine.
(B) Polyether amine.
(C) Polyalkylsuccinimide.
(D) Polyalkylaminophenol.
[[Page 11]]
(E) Detergent-active petroleum-based carrier oil.
(F) Detergent-active synthetic carrier oil.
(G) Other detergent-active component (identify category, if
feasible).
(iii) Composition variability. (A) The composition of a detergent
additive reported in a single additive registration (and the detergent
additive product sold under a single additive registration) may not
include the following:
(1) Detergent-active components that differ in identity from those
contained in the detergent additive package at the time of deposit
control testing.
(2) A range of concentrations for any detergent-active component
such that, if the component were present in the detergent additive
package at the lower bound of the reported range, the deposit control
effectiveness of the additive package would be reduced as compared with
the level of effectiveness demonstrated pursuant to the requirements of
40 CFR 1090.260. Subject to the foregoing constraint, a gasoline
detergent additive sold under a particular additive registration may
contain a higher concentration of the detergent-active component(s) than
the concentration(s) of such component(s) reported in the registration
for the additive.
(B) The identity or concentration of non-detergent-active components
of the detergent additive package may vary under a single registration
provided that such variability does not reduce the deposit control
effectiveness of the additive package as compared with the level of
effectiveness demonstrated pursuant to the requirements of 40 CFR
1090.260.
(C) Unless the additive manufacturer provides EPA with data to
substantiate that a carrier oil does not act to enhance the detergent
additive's ability to control deposits, any carrier oil contained in the
detergent additive, whether petroleum-based or synthetic, must be
treated as a detergent-active component in accordance with the
requirements in paragraph (j)(3)(ii) of this section.
(D) Except as provided in paragraph (j)(3)(iii)(E) of this section,
detergent additive packages that do not satisfy the requirements in
paragraphs (j)(3)(iii)(A) through (C) must be separately registered. EPA
may disqualify an additive for use in satisfying the requirements of
this subpart if EPA determines that the variability included within a
given detergent additive registration may reduce the deposit control
effectiveness of the detergent package such that it may invalidate the
lowest additive concentration reported in accordance with the
requirements of paragraph (j)(1) of this section and 40 CFR 1090.260.
(E) A change in minimum concentration requirements resulting from a
modification of detergent additive composition does not require a new
detergent additive registration or a change in existing registration if
the modification is affected by a detergent blender pursuant to the
requirements of 40 CFR 1090.1240.
(4) For detergent-active polymers and detergent-active carrier oils
that are reported as the product of other chemical reactants:
(i) Identification of the reactant materials and the manufacturer's
acceptance criteria for determining that these materials are suitable
for use in synthesizing detergent components. The manufacturer must
maintain documentation, and submit it to EPA upon request, demonstrating
that the acceptance criteria reported to EPA are the same criteria which
the manufacturer specifies to the suppliers of the reactant materials.
(ii) A Gel Permeation Chromatograph (GPC), providing the molecular
weight distribution of the polymer or detergent-active carrier oil
components and the concentration of each chromatographic peak
representing more than one percent of the total mass. For these results
to be acceptable, the GPC test procedure must include equipment
calibration with a polystyrene standard or other readily attainable and
generally accepted calibration standard. The identity of the calibration
standard must be provided, together with the GPC characterization of the
standard.
(5) For non-detergent-active carrier oils, the following parameters:
(i) T10, T50, and T90 distillation points, and end boiling point,
measured
[[Page 12]]
according to applicable test procedures cited in 40 CFR 1090.1350.
(ii) API gravity and viscosity.
(iii) Concentration of oxygen, sulfur, and nitrogen, if greater than
or equal to 0.5 percent (by weight) of the carrier oil.
(6) Description of an FTIR-based method appropriate for identifying
the detergent additive package and its detergent-active components
(polymers, carrier oils, and others) both qualitatively and
quantitatively, together with the actual infrared spectra of the
detergent additive package and each detergent-active component obtained
by this test method. The FTIR infrared spectra submitted in connection
with the registration of a detergent additive package must reflect the
results of a test conducted on a sample of the additive containing the
detergent-active component(s) at a concentration no lower than the
concentration(s) (or the lower bound of a range of concentration)
reported in the registration pursuant to paragraph (j)(1) of this
section.
(7) Specific physical parameters must be identified which the
manufacturer considers adequate and appropriate, in combination with
other information in this section, for identifying the detergent
additive package and monitoring its production quality control.
(i) Such parameters must include (but need not be limited to)
viscosity, density, and basic nitrogen content, unless the additive
manufacturer specifically requests, and EPA approves, the substitution
of other parameter(s) which the manufacturer considers to be more
appropriate for a particular additive package. The request must be made
in writing and must include an explanation of how the requested physical
parameter(s) are helpful as indicator(s) of detergent production quality
control. EPA will respond to such requests in writing; the additional
parameters are not approved until the manufacturer receives EPA's
written approval.
(ii) The manufacturer must identify a standardized measurement
method, consistent with the chemical and physical nature of the
detergent product, which will be used to measure each parameter. The
documented ASTM repeatability for the method must also be cited. The
manufacturer's target value for each parameter in the additive, and the
expected range of production values for each parameter, must be
specified.
(iii) The expected range of variability must differ from the target
value by an amount no greater than five times the standard repeatability
of the test procedure, or by no more than 10 percent of the target
value, whichever is less. However, in the case of nitrogen analysis or
other procedures for measuring concentrations of specific chemical
compounds or elements, when the target value is less than 10 parts per
million, a range of variability up to 50 percent of the target value
will be considered acceptable.
(iv) If a manufacturer wishes to rely on measurement methods or
production variability ranges which do not conform to the above
limitations, then the manufacturer must receive prior written approval
from EPA. A request for such allowance must be made in writing. It must
fully justify the adequacy of the test procedure, explain why a broader
range of variability is required, and provide evidence that the
production detergent will perform adequately throughout the requested
range of variability pursuant to the requirements of 40 CFR 1090.1395.
[40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59
FR 33093, June 27, 1994; 85 FR 78463, Dec. 4, 2020]
Sec. 79.22 Determination of noncompliance.
If the Administrator determines that an applicant for registration
of a designated fuel additive has failed to submit all of the
information required by Sec. 79.21, or determines within the applicable
period provided for Agency review that the applicant has not
satisfactorily completed any testing which is required prior to
registration of the fuel additive by any provision of subpart F of this
part, he shall return the application to the manufacturer, along with an
explanation of all deficiencies in the required information.
[59 FR 33093, June 27, 1994]
[[Page 13]]
Sec. 79.23 Registration.
(a) If the Administrator determines that a manufacturer has
submitted an application for registration of a designated fuel additive
which includes all of the information and assurances required by Sec.
79.21 and has satisfactorily completed all of the testing required by
subpart F of this part, the Administrator shall promptly register the
fuel additive and notify the fuel manufacturer of such registration.
(b) The Administrator shall maintain a list of registered additives,
which shall be available to the public upon request.
[40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 59
FR 33093, June 27, 1994]
Sec. 79.24 Termination of registration of additives.
(a) Registration may be terminated by the Administrator if the
additive manufacturer requests such termination in writing.
(b) Registration for an additive that has its purpose-in-use
identified as a deposit control additive for use in gasoline pursuant to
the requirements of Sec. 79.21(d) may be terminated by the
Administrator if the EPA determines that the detergent additive is not
compliant with the gasoline deposit control requirements of 40 CFR
1090.260.
[85 FR 78465, Dec. 4, 2020]
Subpart D_Designation of Fuels and Additives
Sec. 79.30 Scope.
Fuels and additives designated and dates prescribed by the
Administrator for the registration of such fuels and additives, pursuant
to section 211 of the Act, are listed in this subpart. In addition,
specific informational requirements under Sec. Sec. 79.11(f) and
79.21(e) are set forth for each designated fuel or additive. Additional
fuels and/or additives may be designated and pertinent dates and
additional specific informational requirements prescribed as the
Administrator deems advisable.
Sec. 79.31 Additives.
(a) All additives produced or sold for use in motor vehicle gasoline
and/or motor vehicle diesel fuel are hereby designated. The Act defines
the term ``motor vehicle'' to mean any self-propelled vehicle designed
for transporting persons or property on a street or highway. For
purposes of this registration, however, additives specifically
manufactured and marketed for use in motorcycle fuels are excluded.
(b) All designated additives must be registered by July 7, 1976.
(c) In accordance with Sec. Sec. 79.5(b) and 79.21(e), and to the
extent such information is known to the additive manufacturer as a
result of testing conducted for reasons other than additive registration
or reporting purposes, the additive manufacturer shall furnish the
highest, lowest, and average values of the impurities in each designated
additive, if greater than 0.1 percent by weight. The methods of analysis
in making the determinations shall also be given.
(d) In accordance with Sec. Sec. 79.5(b) and 79.21(e), and to the
extent such information is known to the additive manufacturer, he shall
furnish summaries of any information developed by or specifically for
him concerning the following items:
(1) Mechanisms of action of the additive;
(2) Reactions between the additive and the fuels listed in paragraph
(a) of this section;
(3) Identification and measurement of the emission products of the
additive when used in the fuels listed in paragraph (a) of this section;
(4) Effects of the additive on all emissions;
(5) Toxicity and any other public health or welfare effects of the
emission products of the additive;
(6) Effects of the emission products of the additive on the
performance of emission control devices/systems. Such submissions shall
be accompanied by a description of the test procedures used in obtaining
the information. Information will be considered to be known to the
additive manufacturer if a report
[[Page 14]]
thereon has been prepared and circulated or distributed outside the
research department or division.
(Secs. 211, 301(a), Clean Air Act as amended (40 U.S.C. 7545, 7601(a)))
[40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 43
FR 28490, June 30, 1978; 59 FR 33093, June 27, 1994]
Sec. 79.32 Motor vehicle gasoline.
(a) The following fuels commonly or commercially known or sold as
motor vehicle gasoline are hereby individually designated:
(1) Motor vehicle gasoline, unleaded--motor vehicle gasoline that
contains no more than 0.05 gram of lead per gallon;
(2) Motor vehicle gasoline, leaded, premium--motor vehicle gasoline
that contains more than 0.05 gram of lead per gallon and is sold as
``premium;''
(3) Motor vehicle gasoline, leaded, non-premium--motor vehicle
gasoline that contains more than 0.05 gram of lead per gallon but is not
sold as ``premium.''
The Act defines the term ``motor vehicle'' to mean any self-propelled
vehicle designed for transporting persons or property on a street or
highway. For purposes of this registration, however, gasoline
specifically blended and marketed for motorcycles is excluded.
(b) All designated motor vehicle gasolines must be registered by
September 7, 1976.
(c) Fuel manufacturers must submit the reports specified in 40 CFR
part 1090, subpart J.
(d) In accordance with Sec. Sec. 79.5(a)(2) and 79.11(f), and to
the extent such information is known to the fuel manufacturer, he shall
furnish summaries of any information developed by or specifically for
him concerning the following items:
(1) Mechanisms of action of each additive he reports;
(2) Reactions between such additives and motor vehicle gasoline;
(3) Identification and measurement of the emission products of such
additives when used in motor vehicle gasoline;
(4) Effects of such additives on all emissions;
(5) Toxicity and any other public health or welfare effects of the
emission products of such additives;
(6) Effects of the emission products of such additives on the
performance of emission control devices/systems. Such submissions shall
be accompanied by a description of the test procedures used in obtaining
the information. Information will be considered to be known to the fuel
manufacturer if a report thereon has been prepared and circulated or
distributed outside the research department or division.
[40 FR 52011, Nov. 7, 1975, as amended at 41 FR 21324, May 25, 1976; 85
FR 78465, Dec. 4, 2020]
Sec. 79.33 Motor vehicle diesel fuel.
(a) The following fuels commonly or commercially known or sold as
motor vehicle diesel fuel are hereby individually designated:
(1) Motor vehicle diesel fuel, grade 1-D;
(2) Motor vehicle diesel fuel, grade 2-D.
The Act defines the term ``motor vehicle'' to mean any self-propelled
vehicle designed for transporting persons or property on a street or
highway.
(b) All designated motor vehicle diesel fuels must be registered
within 12 months after promulgation of this part.
(c) Fuel manufacturers must submit the reports specified in 40 CFR
part 1090, subpart J.
(d) In accordance with Sec. Sec. 79.5(a)(2) and 79.11(f), and to
the extent such information is known to the fuel manufacturer, he shall
furnish summaries of any information developed by or specifically for
him concerning the following items:
(1) Mechanisms of action of each additive he reports;
(2) Reactions between such additives and motor vehicle diesel fuel;
(3) Identification and measurement of the emission products of such
additives when used in motor vehicle diesel fuel;
(4) Effects of such additives on all emissions;
(5) Toxicity and any other public health or welfare effects of the
emission products of such additives.
[[Page 15]]
Such submission shall be accompanied by a description of the test
procedures used in obtaining the information. Information will be
considered to be known to the fuel manufacturer if a report thereon has
been prepared and circulated or distributed outside the research
department or division.
[40 FR 52011, Nov. 7, 1975, as amended at 85 FR 78465, Dec. 4, 2020]
Subpart E [Reserved]
Subpart F_Testing Requirements for Registration
Source: 59 FR 33093, June 27, 1994, unless otherwise noted.
Sec. 79.50 Definitions.
The definitions listed in this section apply only to subpart F of
this part.
Additive/base fuel mixture means the mixture resulting when a fuel
additive is added in specified proportion to the base fuel of the fuel
family to which the additive belongs.
Aerosol additive means a chemical mixture in aerosol form generally
used as a motor vehicle engine starting aid or carburetor cleaner and
not recommended to be placed in the fuel tank.
Aftermarket fuel additive means a product which is added by the end-
user directly to fuel in a motor vehicle or engine to modify the
performance or other characteristics of the fuel, the engine, or its
emissions.
Atypical element means any chemical element found in a fuel or
additive product which is not allowed in the baseline category of the
associated fuel family, and an ``atypical fuel or fuel additive'' is a
product which contains such an atypical element.
Base fuel means a generic fuel formulated from a set of
specifications to be representative of a particular fuel family.
Basic emissions means the total hydrocarbons, carbon monoxide,
oxides of nitrogen, and particulates occurring in motor vehicle or
engine emissions.
Bulk fuel additive means a product which is added to fuel at the
refinery as part of the original blending stream or after the fuel is
transported from the refinery but before the fuel is purchased for
introduction into the fuel tank of a motor vehicle.
Emission characterization means the determination of the chemical
composition of emissions.
Emission generation means the operation of a vehicle or engine or
the vaporization of a fuel or additive/fuel mixture under controlled
conditions for the purpose of creating emissions to be used for testing
purposes.
Emission sampling means the removal of a fraction of collected
emissions for testing purposes.
Emission speciation means the analysis of vehicle or engine
emissions to determine the individual chemical compounds which comprise
those emissions.
Engine Dynamometer Schedule (EDS) means the transient engine speed
versus torque time sequence commonly used in heavy-duty engine
evaluation. The EDS for heavy-duty diesel engines is specified in 40 CFR
part 86, appendix I(f)(2).
Evaporative Emission Generator (EEG) means a fuel tank or vessel to
which heat is applied to cause a portion of the fuel to evaporate at a
desired rate.
Evaporative emissions means chemical compounds emitted into the
atmosphere by vaporization of contents of a fuel or additive/fuel
mixture.
Evaporative fuel means a fuel which has a Reid Vapor Pressure (RVP,
pursuant to 40 CFR part 80, appendix ``E'') of 2.0 pounds per square
inch or greater and is not supplied to motor vehicle engines by way of
sealed containment and delivery systems.
Evaporative fuel additive means a fuel additive which, when mixed
with its specified base fuel, causes an increase in the RVP of the base
fuel by 0.4 psi or more relative to the RVP of the base fuel alone and
results in an additive/base fuel mixture whose RVP is 2.0 psi, or
greater. Excluded from this definition are fuel additives used with
fuels which are supplied to motor vehicle engines by way of sealed
containment and delivery systems.
Federal Test Procedure (FTP) means the body of exhaust and
evaporative emissions test procedures described in 40 CFR 86 for the
certification of new
[[Page 16]]
motor vehicles to Federal motor vehicle emissions standards.
Fuel family means a set of fuels and fuel additives which share
basic chemical and physical formulation characteristics and can be used
in the same engine or vehicle.
Manufacturer means a person who is a fuel manufacturer or additive
manufacturer as defined in Sec. 79.2 (d) and (f).
Nitrated polycyclic aromatic hydrocarbons (NPAH) means the class of
compounds whose molecular structure includes two or more aromatic rings
and contains one or more nitrogen substitutions.
Non-catalyzed emissions means exhaust emissions not subject to an
effective aftertreatment device such as a functional catalyst or
particulate trap.
Oxygenate compound means an oxygen-containing, ashless organic
compound, such as an alcohol or ether, which may be used as a fuel or
fuel additive.
Polycyclic aromatic hydrocarbons (PAH) means the class of
hydrocarbon compounds whose molecular structure includes two or more
aromatic rings.
Relabeled additive means a fuel additive which is registered by its
original manufacturer with EPA and is also registered and sold,
unchanged in composition, under a different label and/or by a different
entity.
Semi-volatile organic compounds means that fraction of gaseous
combustion emissions which consists of compounds with greater than
twelve carbon atoms and can be trapped in sorbent polymer resins.
Urban Dynamometer Driving Schedule (UDDS) means the 1372 second
transient speed driving sequence used by EPA to simulate typical urban
driving. The UDDS for light-duty vehicles is described in 40 CFR part
86, appendix I(a).
Vapor phase means the gaseous fraction of combustion emissions.
Vehicle classes/subclasses means the divisions of vehicle groups
within a vehicle type, including light-duty vehicles, light-duty trucks,
and heavy-duty vehicles as specified in 40 CFR part 86.
Vehicle type means the divisions of motor vehicles according to
combustion cycle and intended fuel class, including, but not necessarily
limited to, Otto cycle gasoline-fueled vehicles, Otto cycle methanol-
fueled vehicles, diesel cycle diesel-fueled vehicles, and diesel cycle
methanol-fueled vehicles.
Whole emissions means all components of unfiltered combustion
emissions or evaporative emissions.
Sec. 79.51 General requirements and provisions.
(a) Overview of requirements. (1) All manufacturers of fuels and
fuel additives that are designated for registration under this part are
required to comply with the requirements of subpart F of this part
either on an individual basis or as a participant in a group of
manufacturers of the same or similar fuels and fuel additives, as
defined in Sec. 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 Sec. 79.51(b) and the special
provisions in Sec. 79.58, shall submit all Tier 1 and Tier 2
information required by Sec. Sec. 79.52, 79.53 and 79.59 for each fuel
or additive, except that the Tier 1 emission characterization
requirements in Sec. 79.52(b) and/or the Tier 2 testing requirements in
Sec. 79.53 may be satisfied by adequate existing information pursuant
to the Tier 1 literature search requirements in Sec. 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 Sec. Sec. 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 (Sec. 79.54) shall apply.
(2) Laboratory facilities shall perform testing in compliance with
Good
[[Page 17]]
Laboratory Practice (GLP) requirements as those requirements apply to
inhalation toxicology studies. All studies shall be monitored by the
facilities' Quality Assurance units (as specified in Sec. 79.60).
(b) Group Applications. Subject to the provisions of Sec. 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 Sec. 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 Sec. 79.56 (d) and (e). Nothing
in this subsection (b) shall be deemed to require a manufacturer to rely
on another manufacturer's testing.
(c) Application Procedures and Dates. Each application submitted in
compliance with this subpart shall be signed by the manufacturer of the
designated fuel or additive, or by the manufacturer's agent, and shall
be submitted to the address and in the format prescribed in Sec. 79.59.
A manufacturer who chooses to comply as part of a group pursuant to
Sec. 79.56 shall be covered by the group's joint application. Subject
to any modifications pursuant to the special provisions in Sec. Sec.
79.51(f) or 79.58, the schedule for compliance with the requirements of
this subpart is as follows:
(1) Fuels and fuel additives with existing registrations. (i) The
manufacturer of a fuel or fuel additive product which, pursuant to
subpart B or C of this part, is registered as of May 27, 1994 must
submit the additional basic registration data specified in Sec.
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 Sec. Sec. 79.52,
79.53, and 79.59; or
(B) No later than May 27, 1997, all applicable Tier 1 requirements
(pursuant to Sec. Sec. 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 Sec.
79.53(c)(1). In addition, by May 26, 2000, all applicable Tier 2
requirements (pursuant to Sec. Sec. 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 Sec. 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 Sec.
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 Sec. 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 Sec.
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 Sec.
79.56(e)(4)(iii)(A) (1) and (2)):
(A) All applicable Tier 1 requirements, pursuant to Sec. Sec. 79.52
and 79.59, must be submitted to EPA by May 27, 1997.
(B) Tier 2 requirements, pursuant to Sec. Sec. 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:
[[Page 18]]
(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 Sec. 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 Sec. 79.56(e)(4)(ii)(B)(2)):
(A) All applicable Tier 1 requirements, pursuant to Sec. Sec. 79.52
and 79.59, must be submitted to EPA by March 17, 1998.
(B) Tier 2 requirements, pursuant to Sec. Sec. 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 Sec. 79.53(c)(1). In
addition, all applicable Tier 2 requirements must be submitted to EPA by
May 27, 2000.
(2) Registrable fuels and fuel additives. (i) A fuel product which
is not registered pursuant to subpart B of this part as of May 27, 1994
shall be considered registrable if, under the criteria established by
Sec. 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 Sec. 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 Sec. 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 Sec.
79.59(b)) for that product as part of the application for registration.
If the Administrator determines that the product is registrable under
this section, then the Administrator shall promptly register the
product, provided that the applicant has satisfied all of the other
requirements for registration under subpart B or subpart C of this part,
and contingent upon satisfactory submission of required information
under paragraph (c)(2)(iii) of this section.
(iii) Registration of a registrable fuel or additive shall be
subject to the same requirements and compliance schedule as specified in
paragraph (c)(1) of this section for existing fuels and fuel additives.
Accordingly, manufacturers of registrable fuels or additives may be
granted and may retain registration for such products only if any
applicable and due Tier 1, 2, and 3 requirements have also been
satisfied by either the manufacturer of the product or the fuel/additive
group to which the product belongs.
(3) New fuels and fuel additives. A fuel product shall be considered
new if it is not registered pursuant to subpart B of this part as of May
27, 1994 and if, under the criteria established by Sec. 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 Sec. 79.56,
the fuel/
[[Page 19]]
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 Sec. 79.59(b))
for the product in question. For such new product, the manufacturer must
satisfactorily complete all applicable Tier 1 and Tier 2 requirements,
followed by any Tier 3 testing which the Administrator may require,
before registration will be granted.
(d) Notifications. Upon receipt of a manufacturer's (or group's)
submittal in compliance with the requirements of this subpart, EPA will
notify such manufacturer (or group) that the application has been
received and what, if any, information, testing, or retesting is
necessary to bring the application into compliance with the requirements
of this subpart. EPA intends to provide such notification of receipt in
a timely manner for each such application.
(1) Registered fuel and fuel additive notification. (i) The
manufacturer of a registered fuel or fuel additive product who is
notified that the submittal for such product contains adequate
information pursuant to the Tier 1 and Tier 2 testing and reporting
requirements (Sec. Sec. 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 Sec. 79.4.
(ii) If the manufacturer of a registered fuel or fuel additive
product is notified that testing or retesting is necessary to bring the
Tier 1 and/or Tier 2 submittal into compliance, the continued sale or
importation of the product shall be conditional upon satisfactorily
completing the requirements within the time frame specified in paragraph
(c)(1) of this section.
(iii) EPA intends to notify the manufacturer of the adequacy of the
submitted data within two years of EPA's receipt of such data. However,
EPA retains the right to require that adequate data be submitted to EPA
if, upon subsequent review, EPA finds that the original Tier 1 and/or
Tier 2 submittal is not consistent with the requirements of this
subpart. If EPA does not notify the manufacturer of the adequacy of the
Tier 1 and/or Tier 2 data within two years, EPA will not hold the
manufacturer liable for penalties for violating this rule for the period
beginning when the data was due until the time EPA notifies the
manufacturer of the violation.
(iv) If the manufacturer of a registered fuel or fuel additive
product is notified (pursuant to Sec. 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 Sec. 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 Sec. 79.51(f)(6).
(v) EPA retains the right to require additional Tier 3 testing
pursuant to the procedures in Sec. 79.54.
(2) New fuel and fuel additive notification. (i) Within six months
following its receipt of the Tier 1 and Tier 2 submittal for a new
product (as defined in paragraph (c)(3) of this section), EPA shall
notify the manufacturer of the adequacy of such submittal in compliance
with the requirements of Sec. Sec. 79.52, 79.53, and 79.59 (a) through
(c).
(A) If EPA notifies the manufacturer that testing, retesting, or
additional information is necessary to bring the Tier 1 and Tier 2
submittal into compliance, the manufacturer shall remedy all
inadequacies and provide Tier 3 data, if required, before EPA shall
consider the requirements for registration to have been met for the
product in question.
(B) If EPA does not notify the manufacturer of the adequacy of the
Tier 1 and Tier 2 submittal within six months following the submittal,
the manufacturer shall be deemed to have satisfactorily completed Tiers
1 and 2.
(ii) Within six months of the date on which EPA notifies the
manufacturer of satisfactory completion of Tiers 1 and 2 for a new
product, or within one year of the submittal of the Tier 1 and
[[Page 20]]
Tier 2 data (whichever is earlier), EPA shall determine whether
additional testing is currently needed under the provisions of Tier 3
and, pursuant to Sec. 79.54(b), shall notify the manufacturer of its
determination.
(A) If the manufacturer of a new fuel or fuel additive product is
notified that Tier 3 testing is required for such product, then EPA
shall have the authority to withhold registration until the specified
Tier 3 requirements have been satisfactorily completed. EPA shall
determine whether the Tier 3 requirements have been met, and shall
notify the manufacturer of this determination, within one year of
receiving the manufacturer's Tier 3 submittal.
(B) If EPA does not notify the manufacturer of potential Tier 3
requirements within the prescribed timeframe, then additional testing at
the Tier 3 level is deemed currently unnecessary and the manufacturer
shall be considered to have complied with all current registration
requirements for the new fuel or additive product.
(iii) Upon completion of all current Tier 1, Tier 2, and Tier 3
requirements, and submission of an application for registration which
includes all of the information and assurances required by Sec. 79.11
or Sec. 79.21, the registration of the new fuel or additive shall be
granted, and the registrant may then sell, offer for sale, or introduce
into commerce the registered product as permitted by Sec. 79.4.
(iv) Once the new product becomes registered, EPA reserves the right
to require additional Tier 3 testing pursuant to the procedures
specified in Sec. 79.54.
(e) Inspection of a testing facility. (1) A testing facility,
whether engaged in emissions analysis or health and/or welfare effects
testing under the regulations in this subpart, shall permit an
authorized employee or duly designated representative of EPA, at
reasonable times and in a reasonable manner, to inspect the facility and
to inspect (and in the case of records also to copy) all records and
specimens required to be maintained regarding studies to which this
subpart applies. The records inspection and copying requirements shall
not apply to quality assurance unit records of findings and problems, or
to actions recommended and taken, except the EPA may seek production of
these records in litigation or informal hearings.
(2) EPA will not consider reliable for purposes of showing that a
test substance does or does not present a risk of injury to health or
the environment any data developed by a testing facility or sponsor that
refuses to permit inspection in accordance with this section. The
determination that a study will not be considered reliable does not,
however, relieve the sponsor of a required test of any obligation under
any applicable statute or regulation to submit the results of the study
to EPA.
(3) Effects of non-compliance. Pursuant to sections 114, 208, and
211(d) of the CAA, it shall be a violation of this section and a
violation of 40 CFR part 79, subpart F to deny entry to an authorized
employee or duly designated representative of EPA for the purpose of
auditing a testing facility or test data.
(f) Penalties and Injunctive Relief. (1) Any person who violates
these regulations shall be subject to a civil penalty of up to $25,000
for each and every day of the continuance of the violation and the
economic benefit or savings resulting from the violation. Action to
collect such civil penalties shall be commenced in accordance with
paragraph (b) of section 205 of the Clean Air Act or assessed in
accordance with paragraph (c) of section 205 of the Clean Air Act, 42
U.S.C. 7524 (b) and (c).
(2) Under section 205(b) of the CAA, the Administrator may commence
a civil action for violation of this subpart in the district court of
the United States for the district in which the violation is alleged to
have occurred or in which the defendant resides or has a principal place
of business.
(3) Under section 205(c) of the CAA, the Administrator may assess a
civil penalty of $25,000 for each and every day of the continuance of
the violation and the economic benefit or savings resulting from the
violation, except that the maximum penalty assessment shall not exceed
$200,000, unless the Administrator and the Attorney General jointly
determine that a matter involving a larger penalty amount is appropriate
for administrative penalty assessment.
[[Page 21]]
Any such determination by the Administrator and the Attorney General
shall not be subject to judicial review.
(4) The Administrator may, upon application by the person against
whom any such penalty has been assessed, remit or mitigate, with or
without conditions, any such penalty.
(5) The district courts of the United States shall have jurisdiction
to compel the furnishing of information and the conduct of tests
required by the Administrator under these regulations and to award other
appropriate relief. Actions to compel such actions shall be brought by
and in the name of the United States. In any such action, subpoenas for
witnesses who are required to attend a district court in any district
may run into any other district.
(6) Cancellation. (i) The Administrator of EPA may issue a notice of
intent to cancel a fuel or fuel additive registration if the
Administrator determines that the registrant has failed to submit in a
timely manner any data required to maintain registration under this part
or under section 211(b) or 211(e) of the Clean Air Act.
(ii) Upon issuance of a notice of intent to cancel, EPA will forward
a copy of the notice to the registrant by certified mail, return receipt
requested, at the address of record given in the registration, along
with an explanation of the reasons for the proposed cancellation.
(iii) The registrant will be afforded 60 days from the date of
receipt of the notice of intent to cancel to submit written comments
concerning the notice, and to demonstrate or achieve compliance with the
specific data requirements which provide the basis for the proposed
cancellation. If the registrant does not respond in writing within 60
days from the date of receipt of the notice of intent to cancel, the
cancellation of the registration shall become final by operation of law
and the Administrator shall notify the registrant of such cancellation.
If the registrant responds in writing within 60 days from the date of
receipt of the notice of intent to cancel, the Administrator shall
review and consider all comments submitted by the registrant before
taking final action concerning the proposed cancellation. The
registrants' communications should be sent to the following address:
Attn: Fuel/Additives Registration, U.S. Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Mail Code 6405A, Washington, DC 20460.
(iv) As part of a written response to a notice of intent to cancel,
a registrant may request an informal hearing concerning the notice. Any
such request shall state with specificity the information the registrant
wishes to present at such a hearing. If an informal hearing is
requested, EPA shall schedule such a hearing within 60 days from the
date of receipt of the request. If an informal hearing is held, the
subject matter of the hearing shall be confined solely to whether or not
the registrant has complied with the specific data requirements which
provide the basis for the proposed cancellation. If an informal hearing
is held, the designated presiding officer may be any EPA employee, the
hearing procedures shall be informal, and the hearing shall not be
subject to or governed by 40 CFR part 22 or by 5 U.S.C. 554, 556, or
557. A verbatim transcript of each informal hearing shall be kept and
the Administrator shall consider all relevant evidence and arguments
presented at the hearing in making a final decision concerning a
proposed cancellation.
(v) If a registrant who has received a notice of intent to cancel
submits a timely written response, and the Administrator decides after
reviewing the response and the transcript of any informal hearing to
cancel the registration, the Administrator shall issue a final
cancellation order, forward a copy of the cancellation order to the
registrant by certified mail, and promptly publish the cancellation
order in the Federal Register. Any cancellation order issued after
receipt of a timely written response by the registrant shall become
legally effective five days after it is published in the Federal
Register.
(g) Modification of Regulation. (1) In special circumstances, a
manufacturer subject to the registration requirements of this rule may
petition the Administrator to modify the mandatory testing requirements
in the test standard for any test required by this rule
[[Page 22]]
by application to Director, Field Operations and Support Division, at
the address in paragraph (f)(6)(iii) of this section.
(i) Such request shall be made as soon as the test sponsor is aware
that the modification is necessary, but in no event shall the request be
made after 30 days following the event which precipitated the request.
(ii) Upon such request, the Administrator may, in circumstances
which are outside the control of the manufacturer(s) or his/their agent
and which could not have been reasonably foreseen or avoided, modify the
mandatory testing requirements in the rule if such requirements are
infeasible.
(iii) If the Administrator determines that such modifications would
not significantly alter the scope of the test, EPA will not ask for
public comment before approving the modification. The Administrator will
notify the test sponsor by certified mail of the response to the
request. EPA will place copies of each application and EPA response in
the public docket. EPA will publish a notice in the Federal Register
annually describing such changes which have occurred during the previous
year. Until such Federal Register notice is published, any modification
approved by EPA shall apply only to the person or group who requested
the modification; EPA shall state the applicability of each modification
in such notice.
(iv) Where, in EPA's judgment, the requested modification of a test
standard would significantly change the scope of the test, EPA will
publish a notice in the Federal Register requesting comment on the
request and proposed modification. However, EPA may approve a requested
modification of a test standard without first seeking public comment if
necessary to preserve the validity of an ongoing test undertaken in good
faith.
(2) [Reserved]
(h) Special Requirements for Additives. When an additive is the test
subject, the following rules apply:
(1) All required emission characterization and health effects
testing procedures shall be performed on the mixture which results when
the additive is combined with the base fuel for the appropriate fuel
family (as specified in Sec. 79.55) at the maximum concentration
recommended by the additive manufacturer pursuant to Sec. 79.21(d).
This combination shall be known as the additive/base fuel mixture.
(i) The appropriate fuel family to be utilized for the additive/base
fuel mixture is the fuel family which contains the specific type(s) of
fuel for which the additive is presently registered or for which the
manufacturer of the additive is seeking registration.
(ii) Additives belonging to more than one fuel family.
(A) If an additive product is registered in two or more fuel
families as of May 27, 1994, then the manufacturer of that additive is
responsible for testing (or participating in group testing of) the
respective additive/base fuel mixtures in compliance with the
requirements of this subpart for each fuel family in which the
manufacturer wishes to maintain a registration for its additive.
(B) If a manufacturer is seeking to register such additive in two or
more fuel families then, for testing and registration purposes, the
additive shall be considered to be a member of each fuel family in which
the manufacturer is seeking registration. The manufacturer is
responsible for testing (or participating in group testing of) the
respective additive/base fuel mixture in compliance with the
requirements of this subpart for each fuel family in which the
manufacturer wishes to obtain a product registration for its additive.
(iii) In the case of the methanol fuel family, which contains two
base fuels (M100 and M85 base fuels, pursuant to Sec. 79.55(d)), the
applicable base fuel is the one which represents the fuel/additive group
(specified in Sec. 79.56(e)(4)(i)(C)) containing fuels of which the
most gallons are sold annually.
(iv) Aftermarket additives which are intended by the manufacturer to
be added to the fuel tank only at infrequent intervals shall be applied
according to the manufacturer's specifications during mileage
accumulation, pursuant to Sec. 79.57(c). However, during emission
generation and testing, each tankful of fuel used must contain the
[[Page 23]]
fuel additive at its maximum recommended level. If the additive
manufacturer believes that this maximum treatment rate will cause
adverse effects to the test engine and/or that the engine's emissions
may be subject to artifacts due to overuse of the additive, then the
manufacturer may submit a request to EPA for modification of this
requirement and related test procedures. Such request must include
objective evidence that the modification(s) are needed, along with data
demonstrating the maximum concentration of the additive which may
actually reach the fuel tanks of vehicles in use.
(v) Additives produced exclusively for use in 1 diesel fuel shall
be tested in the diesel base fuel specified in Sec. 79.55(c), even
though that base fuel is formulated with 2 diesel fuel. If a
manufacturer is concerned that emissions generated from this combination
of fuel and additive are subject to artifacts due to this blending, then
that manufacturer may submit a request for a modification in test
procedure requirements to the EPA. Any such request must include
supporting test results and suggested test modifications.
(vi) Bulk additives which are used intermittently for the direct
purpose of conditioning or treating a fuel during storage or transport,
or for treating or maintaining the storage, pipeline, and/or other
components of the fuel distribution system itself and not the vehicle/
engine for which the fuel is ultimately intended, shall, for purposes of
this program, be added to the base fuel at the maximum concentration
recommended by the additive manufacturer for treatment of the fuel or
distribution system component. However, if the additive manufacturer
believes that this treatment rate will cause adverse effects to the test
engine and/or that the engine's emissions may be subject to artifacts
due to overuse of the additive, then the manufacturer may submit a
request to EPA for modification of this requirement and related test
procedures. Such request must include objective evidence that the
modification(s) are needed, along with data demonstrating the maximum
concentration of the additive which may actually reach the fuel tanks of
vehicles in use.
(2) EPA shall use emissions speciation and health effects data
generated in the analysis of the applicable base fuel as control data
for comparison with data generated for the additive/base fuel mixture.
(i) The base fuel control data may be:
(A) Generated internally as an experimental control in conjunction
with testing done in compliance with registration requirements for a
specific additive; or
(B) Generated externally in the course of testing different
additive(s) belonging to the same fuel family, or in the testing of a
base fuel serving as representative of the baseline group for the
respective fuel family pursuant to Sec. 79.56(e)(4)(i).
(ii) Control data generated using test equipment (including vehicle
model and/or engine, or Evaporative Emissions Generator specifications,
as appropriate) and protocols identical or nearly identical to those
used in emissions and health effects testing of the subject additive/
base fuel mixture would be most relevant for comparison purposes.
(iii) If an additive manufacturer chooses the same vehicle/engine to
independently test the base fuel as an experimental control prior to
testing the additive/base fuel mixture, then the test vehicle/engine
shall undergo two mileage accumulation periods, pursuant to Sec.
79.57(c). The initial mileage accumulation period shall be performed
using the base fuel alone. After base fuel testing, and prior to testing
of the additive/base fuel mixture, a second mileage accumulation period
shall be performed using the additive/base fuel mixture. The procedures
outlined in this paragraph shall not preclude a manufacturer from
testing a base fuel and the manufacturer's additive/base fuel mixture
separately in identical, or nearly identical, vehicles/engines.
(i) Multiple Test Potential for Non-Baseline Products. (1) When the
composition information reported in the registration application or
basic registration data for a gasoline or diesel product meets criteria
for classification as a non-baseline product (pursuant to Sec.
79.56(e)(3)(i)(B) or
[[Page 24]]
Sec. 79.56(e)(3)(ii)(B)), then the manufacturer is responsible for
testing (or participating in group testing) of a separate formulation
for each reported oxygenating compound, specified class of oxygenating
compounds, or other substance which defines a separate non-baseline
fuel/additive group pursuant to Sec. 79.56(e)(4)(ii)(A) or (B). For
each such substance, testing shall be performed on a mixture of the
relevant substance in the appropriate base fuel, formulated according to
the specifications for the corresponding group representatives in Sec.
79.56(e)(4)(ii).
(2) When the composition information reported in the registration
application or basic registration data for a non- baseline gasoline
product contains a range of total oxygenate concentration-in-use which
encompasses gasoline formulations with less than 1.5 weight percent
oxygen as well as gasoline formulations with 1.5 weight percent oxygen
or more, then the manufacturer is required to test (or participate in
applicable group testing of) a baseline gasoline formulation as well as
one or more non-baseline gasoline formulations as described in paragraph
(h)(1) of this section.
(3) When the composition information reported in the registration
application or basic registration data for a non- baseline diesel
product contains a range of total oxygenate concentration-in-use which
encompasses diesel formulations with less than 1.0 weight percent oxygen
as well as diesel formulations with 1.0 weight percent oxygen or more,
then the manufacturer is required to test (or participate in applicable
group testing) of a baseline diesel formulation as well as one or more
non-baseline diesel formulations as described in paragraph (h)(1) of
this section.
(4) The presence in a particular oxygenating additive of small
amounts of other unintended oxygenate compounds as byproducts of the
manufacturing process of the given oxygenating additive does not affect
the grouping of that additive and does not create multiple testing
responsibilities for manufacturers who blend that additive into fuel.
(j) Multiple Test Potential for Atypical Fuel Formulations. When the
composition information reported in the registration application or
basic registration data for a fuel product includes more than one
atypical bulk additive product (pursuant to Sec. 79.56(e)(2)(iii)), and
when these additives belong to different fuel/additive groups (pursuant
to Sec. 79.56(e)(4)(iii)), then:
(1) When such disparate additive products are for the same purpose-
in-use and are not ordinarily used in the fuel simultaneously, the fuel
manufacturer shall be responsible for testing (or participating in the
group testing of) a separate formulation for each such additive product.
Testing related to each additive product shall be performed on a mixture
of the additive in the applicable base fuel, as described in paragraph
(g)(1) of this section, or by participation in the costs of testing the
designated representative of the fuel/additive group to which each
separate atypical additive product belongs.
(2) When the disparate additive products are not for the same
purpose-in-use, the fuel manufacturer shall nevertheless be responsible
for testing a separate formulation for each such additive product, as
described in paragraph (g)(1) of this section, if these additives are
not ordinarily blended together in the same commercial formulation of
the fuel.
(3) When the disparate additive products are ordinarily blended
together in the same commercial formulation of the fuel, then the fuel
manufacturer shall be responsible for the testing of a single test
formulation containing all such simultaneously used atypical additive
products. Alternatively, this responsibility can be satisfied by
enrolling such fuel product in a group which includes other fuel or
additive products with the same total combination of atypical elements
as that occurring in the fuel product in question. If the basic
registration data for the subject fuel includes any alternative
additives which contain atypical elements not represented in the test
formulation, then the fuel manufacturer is also responsible for testing
a separate formulation for each such additional disparate additive
product.
[[Page 25]]
(k) Emission Control System Testing. If any information submitted in
accordance with this subpart or any other information available to EPA
shows that a fuel or fuel additive may have a deleterious effect on the
performance of any emission control system or device currently in use or
which has been developed to a point where in a reasonable time it would
be in general use were such effect avoided, EPA may, in its judgment,
require testing to determine whether such effects in fact exist. Such
testing will be required in accordance with such protocols and schedules
as the Administrator shall reasonably require and shall be paid for by
the fuel or fuel additive manufacturer.
[59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996;
62 FR 12575, Mar. 17, 1997; 85 FR 7069, Feb. 6, 2020]
Sec. 79.52 Tier 1.
(a) General Specifications. Tier 1 requires manufacturers of
designated fuels or fuel additives (or groups of manufacturers pursuant
to Sec. 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 Sec. 79.59 and in
conformance with the reporting requirements thereof, manufacturers shall
provide, pursuant to the timing provisions of Sec. 79.51(c), the
following information.
(b) Emissions Characterization. Manufacturers must provide a
characterization of the emission products which are generated by
evaporation (if required pursuant to Sec. 79.58(b)) and by combustion
of the fuel or additive/base fuel mixture in a motor vehicle. For this
purpose, manufacturers may perform the characterization procedures
described in this section or may rely on existing emission
characterization data. To be considered adequate in lieu of performing
new emission characterization procedures, the data must be the result of
tests using the product in question or using a fuel or additive/base
fuel mixture meeting the same grouping criteria as the product in
question. In addition, the emissions must be generated in a manner
reasonably similar to those described in Sec. 79.57, and the
characterization procedures must be adequately performed and documented
and must give results reasonably comparable to those which would be
obtained by performing the procedures described herein. Reports of
previous tests must be sufficiently detailed to allow EPA to judge the
adequacy of protocols, techniques, and conclusions. After the
manufacturer's submittal of such data, 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.
(1) General Provisions. (i) The emissions to be characterized shall
be generated, collected, and stored according to the processes described
in Sec. 79.57. Characterization of combustion and evaporative emissions
shall be performed separately on each emission sample collected during
the applicable emission generation procedure.
(ii) As provided in Sec. 79.57(d), if the emission generation
vehicle/engine is ordinarily equipped with an emission aftertreatment
device, then all requirements in this section for the characterization
of combustion emissions must be completed both with and without the
aftertreatment device in a functional state. The emissions shall be
generated three times (on three different days) without a functional
aftertreatment device and, if applicable, three times (on three
different days) with a functional aftertreatment device, and each such
time shall be analyzed according to the remaining provisions in this
paragraph (b) of this section.
(iii) Measurement of background emissions: It is required that
ambient/dilution air be analyzed for levels of background chemical
species present at the time of emissions sampling (for both combustion
and evaporative emissions) and that sample values be corrected by
substracting the concentrations contributed by the ambient/dilution air.
Background chemical species measurement/analysis during the FTP is
specified in Sec. Sec. 86.109-94(c)(5) and 86.135-94 of this chapter.
[[Page 26]]
(iv) Concentrations of emission products shall be reported either in
units of grams per mile (g/mi) or grams per brake-horsepower/hour (g/
bhp-hr) (for chassis dynamometer and engine dynamometer test
configurations, respectively), as well as in units of weight percent of
measured total hydrocarbons.
(v) Laboratory practice must be of high quality and must be
consistent with state-of-the-art methods as presented in current
environmental and analytical chemistry literature. Examples of
analytical procedures which may be used in conducting the emission
characterization/speciation requirements of this section can be found
among the references in paragraph (b)(5) of this section.
(2) Characterization of the combustion emissions shall include, for
products in all fuel families (except when expressly noted in this
section):
(i) Determination of the concentration of the basic emissions as
follows: total hydrocarbons, carbon monoxide, oxides of nitrogen, and
particulates. Manufacturers are referred to the vehicle certification
procedures in 40 CFR part 86, subparts B and D (Sec. Sec. 86.101
through 86.145 and Sec. Sec. 86.301 through 86.348) for guidance on the
measurement of the basic emissions of interest to this subpart.
(ii) Characterization of the vapor phase of combustion emissions, as
follows:
(A) Determination of the identity and concentration of individual
species of hydrocarbon compounds containing 12 or fewer carbon atoms.
Such characterization shall begin within 30 minutes after emission
collection is completed.
(B) Determination of the identity and concentration of individual
species of aldehyde and ketone compounds containing eight or fewer
carbon atoms. Characterization of these emissions captured in cartridges
shall be performed within two weeks if the cartridge is stored at room
temperature, and one month if the cartridge is stored at 0 [deg]C or
less. If the emissions are sampled using the impinger method, the sample
must be stored in a capped sample vial at 0 [deg]C or less and
characterized within one week.
(C) Determination of the identity and concentration of individual
species of alcohol and ether compounds containing six or fewer carbon
atoms, for those fuels and additive/base fuel mixtures which contain
alcohol and/or ether compounds containing from one to six carbon atoms
in the uncombusted state. For fuel and additive formulations containing
alcohols or ethers with more than six carbon atoms in the uncombusted
state, alcohol and ether species with that higher number of carbon atoms
or less must be identified and measured in the emissions. Such
characterization shall begin within four hours after emission collection
is completed.
(iii) Characterization of the semi-volatile and particulate phases
of combustion emissions to identify and measure polycyclic aromatic
compounds, as follows:
(A) Analysis for polycyclic aromatic compounds shall not be
conducted at or soon after the start of a recommended engine lubricant
change interval.
(B) Analysis for polycyclic aromatic hydrocarbons (PAHs) and
nitrated polycyclic aromatic hydrocarbons (NPAHs), specified in
paragraph (b)(2)(iii)(D) of this section, need not be done for any fuels
and additives in the methane or propane fuel families, nor for fuels and
additives in the atypical categories of any other fuel families,
pursuant to the definitions of such families and categories in Sec.
79.56.
(C) Analysis for poly-chlorinated dibenzodioxins and dibenzofurans
(PCDD/PCDFs), specified in paragraph (b)(2)(iii)(E) of this section, is
required only for fuels and additives which contain chlorine as an
atypical element, pursuant to paragraph (b)(2)(iv) of this section,
which requires all individual emission products containing atypical
elements to be determined for atypical fuels and additives. However,
manufacturers of baseline and nonbaseline fuels and fuel additives in
all fuel families, except those in the methane and propane fuel
families, are strongly encouraged to conduct these analyses on a
voluntary basis.
(D) The analytical method used to measure species of PAHs and NPAHs
should be capable of detecting at least 1 ppm (equivalent to 0.001
microgram
[[Page 27]]
([micro]g) of compound per milligram of organic extract) of these
compounds in the extractable organic matter. The concentration of each
individual PAH or NPAH compound identified shall be reported in units of
microgram per mile or nanograms per brake-horsepower/hour (for chassis
dynamometer and engine dynamometer test configurations, respectively).
Each compound which is present at 0.001 [micro]g per mile (0.5 nanograms
per brake-horsepower/hour) or more must be identified, measured, and
reported. The following individual species shall be measured:
(1) PAHs:
(i) Benzo(a)anthracene;
(ii) Benzo[b]fluoranthene;
(iii) Benzo[k]fluoranthene;
(iv) Benzo(a)pyrene;
(v) Chrysene;
(vi) Dibenzo[a,h]anthracene; and
(vii) Indeno[1,2,3-c,d]pyrene.
(2) NPAHs:
(i) 7-Nitrobenzo[a]anthracene;
(ii) 6-Nitrobenzo[a]pyrene;
(iii) 6-Nitrochrysene;
(iv) 2-Nitrofluorene; and
(v) 1-Nitropyrene.
(E) The analytical method used to measure species and classes of
PCDD/PCDFs should be capable of detecting at least 1 part per trillion
(ppt) (equivalent to 0.001 picogram (pg) of compound per milligram of
organic extract) of these compounds in the extractable organic matter.
The concentration of each individual PCDD/PCDF compound identified shall
be reported in units of picograms (pg) per mile or picograms per brake-
horsepower/hour (for chassis dynamometer and engine dynamometer test
configurations, respectively). Each compound which is present at 0.5 pg/
mile (0.3 pg/bhp-hr) or more must be identified, measured, and reported.
(1) With respect to measurement of PCDD/PCDFs only, the liquid
extracts from the particulate and semi-volatile emissions fractions may
be combined into one sample for analysis.
(2) The manufacturer is referred to 40 CFR part 60, appendix A,
Method 23 for a protocol which may be used to identify and measure any
potential PCDD/PCDFs which might be present in exhaust emissions from a
fuel or additive/base fuel mixture.
(3) The following individual compounds and classes of compounds of
PCDD/PCDFs shall be identified and measured:
(i) Individual tetra-chloro-substituted dibenzodioxins (tetra-CDDs);
(ii) Individual tetra-chloro-substituted dibenzofurans (tetra-CDFs);
(iii) Penta-CDDs and penta-CDFs, as one class;
(iv) Hexa-CDDs and hexa-CDFs, as one class;
(v) Hepta-CDDs and hepta-CDFs as one class; and
(vi) Octo-CDDs and octo-CDFs as one class.
(iv) With respect to all phases (vapor, semi-volatile, and
particulate) of combustion emissions generated from those fuels and
additive/base fuel mixtures classified in the atypical categories
(pursuant to Sec. 79.56), the identity and concentration of individual
emission products containing such atypical elements shall also be
determined.
(3) For evaporative fuels and evaporative fuel additives,
characterization of the evaporative emissions shall include:
(i) Determination of the concentration of total hydrocarbons for the
applicable vehicle type and class in 40 CFR part 86, subpart B
(Sec. Sec. 86.101 through 86.145).
(ii) Determination of the identity and concentration of individual
species of hydrocarbon compounds containing 12 or fewer carbon atoms.
Such characterization shall begin within 30 minutes after emission
collection is completed.
(iii) In the case of those fuels and additive/base fuel mixtures
which contain alcohol and/or ether compounds in the uncombusted state,
determination of the identity and concentration of individual species of
alcohol and ether compounds containing six or fewer carbon atoms. For
fuel and additive formulations containing alcohols or ethers with more
than six carbon atoms in the uncombusted state, alcohol and ether
species with that higher number of carbon atoms or less must be
identified and measured in the emissions. Such characterization shall
begin within four hours after emission collection is completed.
(iv) In the case of those fuels and additive/base fuel mixtures
which contain
[[Page 28]]
atypical elements, determination of the identity and concentration of
individual emission products containing such atypical elements.
(4) Laboratory quality control. (i) At a minimum, laboratories
performing the procedures specified in this section shall conduct
calibration testing of their emissions characterization equipment before
each new fuel/additive product test start-up. Known samples
representative of the compounds potentially to be found in emissions
from the product to be characterized shall be used to calibrate such
equipment.
(ii) Laboratories performing the procedures specified in this
section shall agree to permit quality control inspections by EPA, and
for this purpose shall admit any EPA Enforcement Officer, upon proper
presentation of credentials, to any facility where vehicles are
conditioned or where emissions are generated, collected, stored,
sampled, or characterized in meeting the requirements of this section.
Such laboratory audits may include EPA distribution of ``blind'' samples
for analysis by participating laboratories.
(5) References. For additional background information on the
emission characterization procedures outlined in this paragraph, the
following references may be consulted:
(i) ``Advanced Emission Speciation Methodologies for the Auto/Oil
Air Quality Improvement Program--I. Hydrocarbons and Ethers,'' Auto Oil
Air Quality Improvement Research Program, SP-920, 920320, SAE, February
1992.
(ii) ``Advanced Speciation Methodologies for the Auto/Oil Air
Quality Improvement Research Program--II. Aldehydes, Ketones, and
Alcohols,'' Auto Oil Air Quality Improvement Research Program, SP-920,
920321, SAE, February 1992.
(iii) ASTM D 5197-91, ``Standard Test Method for Determination of
Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler
Methodology).''
(iv) Johnson J. H., Bagley, S. T., Gratz, L. D., and Leddy, D. G.,
``A Review of Diesel Particulate Control Technology and Emissions
Effects--1992 Horning Memorial Award Lecture,'' SAE Technical Paper
Series, SAE 940233, 1994.
(v) Keith et al., ACS Committee on Environmental Improvement,
``Principles of Environmental Analysis,'' The Journal of Analytical
Chemistry, Volume 55, pp. 2210-2218, 1983.
(vi) Perez, J.M., Jabs, R.E., Leddy, D.G., eds. ``Chemical Methods
for the Measurement of Unregulated Diesel Emissions (CRC-APRAC Project
No. CAPI-1-64), Coordinating Research Council, CRC Report No. 551,
August, 1987.
(vii) Schuetzle, D., ``Analysis of Nitrated Polycyclic Aromatic
Hydrocarbons in Diesel Particulates,'' Analytical Chemistry, Volume 54,
pp. 265-271, 1982.
(viii) Siegl, W.O., et al., ``Improved Emissions Speciation
Methodology for Phase II of the Auto/Oil Air Quality Improvement
Research Program--Hydrocarbons and Oxygenates'', SAE Technical Paper
Series, SAE 930142, 1993.
(ix) Tejada, S. B. et al., ``Analysis of Nitroaromatics in Diesel
and Gasoline Car Emissions,'' SAE Paper No. 820775, 1982.
(x) Tejada, S. B. et al., ``Fluorescence Detection and
Identification of Nitro Derivatives of Polynuclear Aromatic Hydrocarbons
by On-Column Catalytic Reduction to Aromatic Amines,'' Analytical
Chemistry, Volume 58, pp. 1827-1834, July 1986.
(xi) ``Test Method for Determination of C1-C4 Alcohols and MTBE in
Gasoline by Gas Chromatography,'' 40 CFR part 80, appendix F.
(c) [Reserved]
(d) Literature Search. (1) Manufacturers of fuels and fuel additives
shall conduct a literature search and compilation of information on the
potential toxicologic, environmental, and other public welfare effects
of the emissions of such fuels and additives. The literature search
shall include all available relevant information from in-house,
industry, government, and public sources pertaining to the emissions of
the subject fuel or fuel additive or the emissions of similar fuels or
additives, with such similarity determined according to the provisions
of Sec. 79.56.
(2) The literature search shall address the potential adverse
effects of
[[Page 29]]
whole combustion emissions, evaporative emissions, relevant emission
fractions, and individual emission products of the subject fuel or fuel
additive except as specified in the following paragraph. The individual
emission products to be included are those identified pursuant to the
emission characterization procedures specified in paragraph (b) of this
section, other than carbon monoxide, carbon dioxide, nitrogen oxides,
benzene, 1,3-butadiene, acetaldehyde, and formaldehyde.
(3) In the case of the individual emission products of non-baseline
or atypical fuels and additives (pursuant to Sec. 79.56(e)(2)), the
literature data need not be submitted for those emission products which
are the same as the combustion emission products of the respective base
fuel for the product's fuel family (pursuant to Sec. 79.55). For this
purpose, data on the base fuel emission products for the product's fuel
family:
(i) May be found in the literature of previously-conducted, adequate
emission speciation studies for the base fuel, or for a fuel or
additive/fuel mixture capable of grouping with the base fuel (see, for
example, the references in paragraph (b)(5) of this section).
(ii) May be compiled while gathering internal control data during
emissions characterization studies on the manufacturer's non-baseline or
atypical product; or
(iii) May be obtained from various manufacturers in the course of
their testing different additive(s) belonging to the same fuel family,
or in the testing of a base fuel serving as representative of the
baseline group for the respective fuel family.
(e) Data bases. The literature search must include the results of
searching appropriate commercially available chemical, toxicologic, and
environmental databases. The databases shall be searched using, at a
minimum, CAS numbers (when applicable), chemical names, and common
synonyms.
(f) Search period. The literature search shall cover a time period
beginning at least thirty years prior to the date of submission of the
reports specified in Sec. Sec. 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.
(g) References. 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:
(1) Auto/Oil Air Quality Improvement Research Program, Technical
Bulletin 1, December 1990.
(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.
[59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996;
62 FR 12571, Mar. 17, 1997]
Sec. 79.53 Tier 2.
(a) Generally. Subject to the provisions of Sec. 79.53(b) through
(d), the combustion emissions of each fuel or fuel additive subject to
testing under this subpart must be tested in accordance with each of the
testing guidelines in Sec. Sec. 79.60 through 79.68, except that fuels
and additives in the methane and propane fuel families (pursuant to
Sec. 79.56(e)(1)(v) and (vi)) need not undergo the Salmonella
mutagenicity assay in Sec. 79.68). Similarly, subject to the provisions
of Sec. 79.53(b) through (d), the evaporative emissions of each
designated evaporative fuel and each designated evaporative fuel
additive subject to testing under this subpart must be tested according
to each of the testing guidelines in Sec. Sec. 79.60 through 79.67
(excluding Sec. 79.68, Salmonella typhimurium Reverse Mutation Assay).
(b) Manufacturer Determination. Manufacturers shall determine
whether the information gathered pursuant to the literature search in
Sec. 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
Sec. Sec. 79.62 through 79.68 regarding the carcinogenicity,
mutagenicity, neurotoxicity,
[[Page 30]]
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 Sec. 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.
(c) Testing. (1) All testing required pursuant to this section must
be done in accordance with the procedures, equipment, and facility
requirements described in Sec. Sec. 79.57, 79.60, and 79.61 regarding
emissions generation, good laboratory practices, and inhalation exposure
testing, respectively, as well as any other requirements described in
this subpart. The laboratory conducting the animal studies shall be
registered and in good standing with the United States Department of
Agriculture and regularly inspected by United States Department of
Agriculture veterinarians. In addition, the facility must be accredited
by a generally recognized independent organization which sets laboratory
animal care standards. Use of inadequate test protocols or substandard
laboratory techniques in performing any testing required by this subpart
may result in cancellation of all affected registrations.
(2) Carcinogenic or mutagenic effects in animals from emissions
exposures shall be determined pursuant to Sec. 79.64 In vivo
Micronucleus Assay, Sec. 79.65 In vivo Sister Chromatid Exchange Assay,
and Sec. 79.68 Salmonella typhimurium Reverse Mutation Assay.
Teratogenic effects and reproductive toxicity shall be examined pursuant
to Sec. 79.63 Fertility Assessment/Teratology. General toxicity and
pulmonary effects shall be determined pursuant to Sec. 79.62 Subchronic
Toxicity Study with Specific Health Effect Assessments. Neurotoxic
effects shall be determined pursuant to Sec. 79.66 Neuropathology
Assessment and Sec. 79.67 Glial Fibrillary Acidic Protein Assay.
(d) EPA Determination. (1) After submission of all information and
testing, EPA in its judgment shall determine whether previously
conducted tests relied upon in the registration submission are
adequately performed and documented and provide information reasonably
comparable to that which would be provided by the tests described
herein. Manufacturers' submissions shall be sufficiently detailed to
allow EPA to judge the adequacy of protocols, techniques, experimental
design, statistical analyses, and conclusions. Studies shall be
performed using generally accepted scientific principles, good
laboratory techniques, and the testing guidelines specified in these
regulations.
(2) EPA shall give appropriate weight when making this determination
to the following factors:
(i) The age of the data;
(ii) The adequacy of documentation of procedures, findings, and
conclusions;
(iii) The extent to which the testing conforms to generally accepted
scientific principles and practices;
(iv) The type and number of test subjects;
(v) The number and adequacy of exposure concentrations, i.e.,
emission dilutions;
(vi) The degree to which the tested emissions were generated by
procedures and under conditions reasonably comparable to those set forth
in Sec. 79.57; and
(vii) The degree to which the test procedures conform to the testing
guidelines set forth in Sec. Sec. 79.60 through 79.68 and/or furnish
information comparable to that provided by such testing.
(3) The test animals shall be rodents, preferably a strain of rat,
and testing shall include all of the endpoints covered in Sec. Sec.
79.62 through 79.68. All studies shall be properly executed, with
appropriate documentation, and in accord with the individual health
testing guidelines (Sec. Sec. 79.60 through 79.68) of this part, e.g.,
90-day, 6-hour per day exposure, minimum.
[[Page 31]]
(4) In general, the data in a manufacturer's registration submittal
shall be adequate if the duration of a test's exposure period is at
least as long, in days and hours, as the inhalation exposure specified
in the related health test guideline(s). Data from tests with shorter
exposure durations than those specified in the guidelines may be
acceptable if the test results are positive (i.e., exhibit adverse
effects) and/or include a demonstrable concentration-response
relationship.
(5) Data in support of a manufacturer's registration submittal shall
directly address the effects of inhalation exposure to the whole
evaporative and exhaust emissions of the respective fuel or additive or
to the whole evaporative and exhaust emissions of other fuels or
additives which satisfy the criteria in Sec. 79.56 for classification
into the same group as the subject fuel or fuel additive. Data obtained
in the testing of a raw liquid fuel or additive/base fuel mixture or a
raw, aerosolized fuel or additive/base fuel mixture shall not be
adequate to support a manufacturer's registration submittal. Data from
testing of evaporative emissions cannot substitute for test data on
combustion emissions. Data from testing of combustion emissions cannot
substitute for test data on evaporative emissions.
Sec. 79.54 Tier 3.
(a) General Criteria for Requiring Tier 3 Testing. (1) Tier 3
testing shall be required of a manufacturer or group of manufacturers at
EPA's discretion when remaining uncertainties as to the significance of
observed health effects, welfare effects, and/or emissions exposures
from a fuel or fuel/additive mixture interfere with EPA's ability to
make reasonable estimates of the potential risks posed by emissions from
the fuel or additive products. Tier 3 testing may be conducted either on
an individual basis or a group basis. If performed on a group basis, EPA
may require either the same representative to be used in Tier 3 testing
as was used in Tier 2 testing or may select a different member or
members of the group to represent the group in the Tier 3 tests.
(2) In addition to the criteria specific to particular tests as
summarized and detailed in the testing guidelines (Sec. Sec. 79.62
through 79.68), EPA may consider a number of factors (including, but not
limited to):
(i) The number of positive and negative outcomes related to each
endpoint;
(ii) The identification of concentration-effect relationships;
(iii) The statistical sensitivity and significance of such studies;
(iv) The severity of the observed effects (e.g., whether the effects
would be likely to lead to incapacitating or irreversible conditions);
(v) The type and number of species included in the reported tests;
(vi) The consistency and clarity of apparent mechanisms, target
organs, and outcomes;
(vii) The presence or absence of effective health test control data
for base-fuel-only versus additive/base fuel mixture comparisons;
(viii) The nature and amount of known toxic agents in the emissions
stream; and
(ix) The observation of lesions which specifically implicate
inhalation as an important exposure route.
(3) Consideration of exposure. EPA retains discretion to consider,
in addition to available toxicity data, any Tier 1 data on potential
exposures to emissions from a particular fuel or fuel additive (or group
of fuels and/or fuel additives) in determining whether to require Tier 3
testing. EPA may consider, but is not limited to, the following factors:
(i) Types and emission rates of speciated emission components;
(ii) Types and emission rates of combinations of compounds or
elements of concern;
(iii) Historical and/or projected production volumes and market
distributions; and
(iv) Estimated population and/or environmental exposures obtained
through extrapolation, modeling, or literature search findings on
ambient, occupational, or epidemiological exposures.
(b) Notice. (1) EPA will determine whether Tier 3 testing is
necessary upon receipt of a manufacturer's (or group's) submittal as
prescribed under Sec. 79.51(d). If EPA determines on the
[[Page 32]]
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.
(2) EPA will issue a notice in the Federal Register of its intent to
require testing under Tier 3 for a particular fuel or additive
manufacturer and that a copy of the letter to the manufacturer outlining
the Tier 3 testing for that manufacturer is available in the public
record for review and comment. The public shall have a minimum of thirty
(30) days after the publication of this notice to comment on the
proposed Tier 3 testing.
(3) EPA will include in the public record a copy of any timely
comments concerning the proposed Tier 3 testing requirements received
from the affected manufacturer or group or from the public, and the
responses of EPA to such comments. After reviewing all such comments
received, EPA will adopt final Tier 3 requirements by sending a
certified letter describing such final requirements to the manufacturer
or group. EPA will also issue a notice in the Federal Register
announcing that it has adopted such final Tier 3 requirements and that a
copy of the letter adopting the requirements has been included in the
public record.
(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
Sec. 79.51(f).
(c) Carcinogenicity and Mutagenicity Testing. (1) A potential need
for Tier 3 carcinogenicity and/or mutagenicity testing may be indicated
if the results of the In vivo Micronucleus Assay, required under Sec.
79.64, the In vivo Sister Chromatid Exchange Assay, required under Sec.
79.65, the Salmonella mutagenicity assay required under Sec. 79.68, or
relevant pathologic findings under Sec. 79.62 demonstrate a
statistically significant dose-related positive response as compared
with appropriate controls. Alternatively, Tier 3 carcinogenicity testing
and/or mutagenicity testing may be required if there are positive
outcomes for at least one concentration in two or more of the tests
required under Sec. Sec. 79.64, 79.65, and 79.68.
(2) The testing for carcinogenicity required under this paragraph
may, at EPA's discretion, be conducted in accordance with 40 CFR
798.3300 or 798.3320, or their equivalents (see suggested references
following each health effects testing guideline). The testing for
mutagenicity required under this paragraph may likewise be conducted in
accordance with 40 CFR 798.5195, 798.5500, 798.5955, 798.7100, and/or
other suitable equivalent testing (see suggested references following
each health effects testing guideline). EPA may supplement or modify
guidelines as required to ensure that the prescribed testing addresses
the identified areas of concern.
(d) Reproductive and Teratological Effects Testing. (1) A potential
need for Tier 3 testing may be indicated if the results of the Fertility
Assessment/Teratology study required under Sec. 79.63 or relevant
findings under Sec. 79.62 demonstrate, in comparison with appropriate
controls, a statistically significant dose-related positive response in
one or more of the possible test outcomes. Similarly, Tier 3 testing may
be indicated if statistically significant positive results are confined
to either sex, or to the fetus as opposed to the pregnant adult.
(2) The testing for reproductive and teratological effects required
under this paragraph may, at EPA's discretion, be conducted in
accordance with
[[Page 33]]
40 CFR 798.4700 and/or by performance of a reproductive assay by
continuous breeding. These guidelines may be modified or supplemented by
EPA as required to ensure that the prescribed testing addresses the
identified areas of concern.
(e) Neurotoxicity Testing. (1) A potential need for Tier 3
neurotoxicity testing may be indicated if either the results of the
Neuropathology Assessment required under Sec. 79.67 shows
concentration-related effects in exposed animals or the Glial Fibrillary
Acidic Protein Assay required under Sec. 79.66 demonstrates a
statistically significant concentration-related positive response as
compared with appropriate controls. Similarly, Tier 3 neurotoxicity
testing may be indicated if relevant results under Sec. 79.62
demonstrate a statistically significant positive response in comparison
to appropriate controls.
(2) The testing for neurotoxicity required under this paragraph may,
at EPA's discretion, be conducted in accordance with 40 CFR 798.3260 and
40 CFR part 798 subpart G. These guidelines may be modified or
supplemented by EPA as required to ensure that the prescribed testing
addresses the identified areas of concern.
(f) General and Pulmonary Toxicity Testing. (1) A potential need for
Tier 3 general and/or pulmonary toxicity testing may be indicated if, in
comparison with appropriate controls, the results of the Subchronic
Toxicity Study, pursuant to Sec. 79.62, demonstrate abnormal gross
analysis or histopathological findings (especially as relates to lung
pathology from whole-body preserved test animals) or persistence or
delayed occurrence of toxic effects beyond the exposure period.
(2) A potential need for Tier 3 testing with respect to other organ
systems or endpoints not addressed by specific Tier 2 tests, e.g.,
hepatic, renal, or endocrine toxicity, may be demonstrated by findings
in the Tier 2 Subchronic Toxicity Study (pursuant to Sec. 79.62) or by
findings in the Tier 1 literature search of adverse functional,
physiologic, metabolic, or histopathologic effects of fuel or additive
emissions to such other organ systems or any other information available
to EPA. In addition, findings in the Tier 1 emission characterization of
significant levels of a known toxicant to such other organ systems and
endpoints may also indicate a need for relevant health effects testing.
The testing required under this paragraph may include tests conducted in
accordance with 40 CFR 798.3260 or 798.3320. These guidelines may be
modified or supplemented by EPA as necessary to ensure that the
prescribed testing addresses the identified areas of concern.
(3) The testing for general/pulmonary toxicity required under this
paragraph may, at EPA's discretion, be conducted in accordance with 40
CFR 798.2450 or 798.3260. These guidelines may be modified or
supplemented by EPA as necessary to ensure that the prescribed testing
addresses the identified areas of concern. Pulmonary function
measurements, host defense assays, immunotoxicity tests, cell
morphology/morphometry, and/or enzyme assays of lung lavage cells and
fluids may be specifically required.
(g) Other Tier 3 Testing. (1) A manufacturer or group may be
required to use up-to-date modeling, sampling, monitoring, and/or
analytic approaches at the Tier 3 level to provide:
(i) Estimates of exposures to the emission products of a fuel or
fuel additive or group of products;
(ii) The expected atmospheric transformation products of such
emissions; and
(iii) The environmental partitioning of such emissions to the air,
soil, water, and biota.
(2) Additional emission characterization may be required if
uncertainty over the identity of chemical species or rate of their
emission interferes with reasonable judgments as to the presence and/or
concentration of potentially toxic substances in the emissions of a fuel
or fuel additive. The required tests may include characterization of
additional classes of emissions, the characterization of emissions
generated by additional vehicles/engines of various technology mixes
(e.g., catalyzed versus non-catalyzed emissions), and/or other more
precise analytic procedures for identification or quantification of
emissions compounds. Additional emissions testing may also be
[[Page 34]]
required to evaluate concerns which may arise regarding the potential
effects of a fuel or fuel additive on the performance of emission
control equipment.
(3) A manufacturer or group may be required to conduct biological
and/or exposure studies at the Tier 3 level to evaluate directly the
potential public welfare or environmental effects of the emissions of a
fuel or additive, if significant concerns about such effects arise as a
result of EPA's review of the literature search or emission
characterization findings in Tier 1 or the results of the toxicological
tests in Tier 2.
(4) With regard to group submittals, Tier 3 studies on a fuel or
additive product(s) other than the originally specified group
representative may be required if specific differences in the product's
composition indicate that its emissions may have different toxicologic
properties from those of the original group representative.
(5) Additional emission characterization and/or toxicologic tests
may be required to evaluate the impact of different vehicle, engine, or
emission control technologies on the observed composition or health or
welfare effects of the emissions of a fuel or additive.
(6) Toxicological tests on individual emission products may be
required.
(7) Upon review of information submitted for an aerosol product
under Sec. 79.58(e), emissions characterization, exposure, and/or
toxicologic testing at a Tier 3 level may be required.
(8) A manufacturer which qualifies for and has elected to use the
special provisions for the products of small businesses (pursuant to
Sec. 79.58(d)) may be required to conduct emission characterization,
exposure, and/or toxicologic studies at the Tier 3 level for such
products, as specified in Sec. 79.58(d)(4).
(9) The examples of potential Tier 3 tests described in this section
do not in any way limit EPA's broad discretion and authority under Tier
3.
Sec. 79.55 Base fuel specifications.
(a) General Characteristics. (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 Sec. 79.56. Also, as specified
in Sec. 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.
(2) Base fuels shall contain a limited complement of the additives
which are essential for the fuel's production or distribution and/or for
the successful operation of the test vehicle/engine throughout the
mileage accumulation and emission generation periods. Such additives
shall be used at the minimum effective concentration-in-use for the base
fuel in question.
(3) Unless otherwise restricted, the presence of trace contaminants
does not preclude the use of a fuel or fuel additive as a component of a
base fuel formulation.
(4) When an additive is the test subject, any additive normally
contained in the base fuel which serves the same function as the subject
additive shall be removed from the base fuel formulation. For example,
if a corrosion inhibitor were the subject of testing and if this
additive were to be tested in a base fuel which normally contained a
corrosion inhibitor, this test additive would replace the corrosion
inhibitor normally included as a component of the base fuel.
(5) Additive components of the methanol, ethanol, methane, and
propane base fuels in addition to any such additives included below
shall be limited to those recommended by the manufacturers of the
vehicles and/or engines used in testing such fuels. For this purpose,
EPA will review requests from manufacturers (or their agents) to modify
the additive specifications for the alternative fuels and, if necessary,
EPA shall change these specifications based on consistency of those
changes with the associated vehicle manufacturer's recommendations for
the operation of the vehicle. EPA shall publish notice of any such
changes to a base fuel and/or its base additive package specifications
in the Federal Register.
(b) Gasoline Base Fuel. (1) The gasoline base fuel is patterned
after the reformulated gasoline summer baseline fuel as specified in CAA
section
[[Page 35]]
211(k)(10)(B)(i). The specifications and blending tolerances for the
gasoline base fuel are listed in table F94-1. The additive types which
shall be required and/or permissible in the gasoline base fuel are
listed in table 1 as well.
Table F94-1--Gasoline Base Fuel Properties
------------------------------------------------------------------------
------------------------------------------------------------------------
API Gravity.................................. 57.40.3
Sulfur, ppm.................................. 33925
Benzene, vol%................................ 1.530.3
RVP, psi..................................... 8.70.3
Octane, (R + M)/2............................ 87.30.5
Distillation Parameters:
10%, [deg]F................................ 1285
50%, [deg]F................................ 2185
90%, [deg]F................................ 3305
Aromatics, vol%.............................. 32.02.7
Olefins, vol%................................ 9.22.5
Saturates, vol%.............................. 58.82.0
Additive Types:
Required................................... Deposit Control
Corrosion Inhibitor
Demulsifier
Anti-oxidant
Metal Deactivator
Permissible................................ Anti-static
------------------------------------------------------------------------
(2) The additive components of the gasoline base fuel shall contain
compounds comprised of no elements other than carbon, hydrogen, oxygen,
nitrogen, and sulfur. Additives shall be used at the minimum
concentration needed to perform effectively in the gasoline base fuel.
In no case shall their concentration in the base fuel exceed the maximum
concentration recommended by the additive manufacturer. The increment of
sulfur contributed to the formulation by any additive shall not exceed
15 parts per million sulfur by weight and shall not cause the gasoline
base fuel to exceed the sulfur specifications in table F94-1 of this
section.
(c) Diesel Base Fuel. (1) The diesel base fuel shall be a 2 diesel
fuel having the properties and blending tolerances shown in table F94-2
of this section. The additive types which shall be permissible in diesel
base fuel are presented in table F94-2 as well.
Table F94-2--Diesel Base Fuel Properties
------------------------------------------------------------------------
------------------------------------------------------------------------
API Gravity.................................. 331
Sulfur, wt%.................................. 0.050.0025
Cetane Number................................ 45.22
Cetane Index................................. 45.72
Distillation Parameters:
10%, [deg]F................................ 4335
50%, [deg]F................................ 5165
90%, [deg]F................................ 6065
Aromatics, vol%.............................. 38.42.7
Olefins, vol%................................ 1.50.4
Saturates, vol%.............................. 60.12.0
Additive Types:
Required................................... Corrosion Inhibitor
Demulsifier
Anti-oxidant
Metal Deactivator
Permitted.................................. Anti-static
Flow Improver
Not Permitted.............................. Deposit Control
------------------------------------------------------------------------
(2) The additive components of the diesel base fuel shall contain
compounds comprised of no elements other than carbon, hydrogen, oxygen,
nitrogen, and sulfur. Additives shall be used at the minimum
concentration needed to perform effectively in the diesel base fuel. In
no case shall their concentration in the base fuel exceed the maximum
concentration recommended by the additive manufacturer. The increment of
sulfur contributed to the base fuel by additives shall not cause the
diesel base fuel to exceed the sulfur specifications in table F94-2 of
this section.
(d) Methanol Base Fuels. (1) The methanol base fuels shall contain
no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur, and
chlorine.
(2) The M100 base fuel shall consist of 100 percent by volume
chemical grade methanol.
(3) The M85 base fuel is to contain 85 percent by volume chemical
grade methanol, blended with 15 percent by volume gasoline base fuel
meeting the gasoline base fuel specifications outlined in paragraph
(b)(1) of this section. Manufacturers shall ensure the methanol
compatibility of lubricating oils as well as fuel additives used in the
gasoline portion of the M85 base fuel.
(4) The methanol base fuels shall meet the specifications listed in
table F94-3.
Table F94-3--Methanol Base Fuel Properties
------------------------------------------------------------------------
------------------------------------------------------------------------
M100:
Chemical Grade MeOH, vol%.................................. 100
Chlorine (as chlorides), wt%, max.......................... 0.0001
Water, wt%, max............................................ 0.5
Sulfur, wt%, max........................................... 0.002
M85
Chemical Grade MeOH, vol%,................................. 85
Gasoline Base Fuel, vol%................................... 15
Chlorine (as chlorides), wt%, max.......................... 0.0001
Water, wt%, max............................................ 0.5
[[Page 36]]
Sulfur, wt%, max........................................... 0.004
------------------------------------------------------------------------
(e) Ethanol Base Fuel. (1) The ethanol base fuel, E85, shall contain
no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur,
chlorine, and copper.
(2) The ethanol base fuel shall contain 85 percent by volume
chemical grade ethanol, blended with 15 percent by volume gasoline base
fuel that meets the specifications listed in paragraph (b)(1) of this
section. Additives used in the gasoline component of E85 shall be
ethanol-compatible.
(3) The ethanol base fuel shall meet the specifications listed in
table F94-4.
Table F94-4--Ethanol Base Fuel Properties
------------------------------------------------------------------------
------------------------------------------------------------------------
E85:
Chemical Grade EtOH, vol%, min............................. 85
Gasoline Base Fuel, vol%................................... 15
Chlorine (as chloride), wt%, max........................... 0.0004
Copper, mg/L, max.......................................... 0.07
Water, wt%, max............................................ 0.5
Sulfur, wt%, max........................................... 0.004
------------------------------------------------------------------------
(f) Methane Base Fuel. (1) The methane base fuel is a gaseous motor
vehicle fuel marketed commercially as compressed natural gas (CNG),
whose primary constituent is methane.
(2) The methane base fuel shall contain no elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur. The fuel shall contain
an odorant additive for leak detection purposes. The added odorant shall
be used at a level such that, at ambient conditions, the fuel must have
a distinctive odor potent enough for its presence to be detected down to
a concentration in air of not over \1/5\ (one-fifth) of the lower limit
of flammability. After addition of the odorant, the methane base fuel
shall contain no more than 16 ppm sulfur by volume.
(3) The methane base fuel shall meet the specifications listed in
table F94-5.
Table F94-5--Methane Base Fuel Specifications
------------------------------------------------------------------------
------------------------------------------------------------------------
Methane, mole%, min............................................. 89.0
Ethane, mole%, max.............................................. 4.5
Propane and higher HC, mole%, max............................... 2.3
C6 and higher HC, mole%, max.................................... 0.2
Oxygen, mole%, max.............................................. 0.6
Sulfur (including odorant additive) ppmv, max................... 16
Inert gases:
Sum of CO2 and N2, mole%, max................................. 4.0
------------------------------------------------------------------------
(g) Propane Base Fuel. (1) The propane base fuel is a gaseous motor
vehicle fuel, marketed commercially as liquified petroleum gas (LPG),
whose primary constituent is propane.
(2) The propane base fuel may contain no elements other than carbon,
hydrogen, oxygen, nitrogen, and sulfur. The fuel shall contain an
odorant additive for leak detection purposes. The added odorant shall be
used at a level such that at ambient conditions the fuel must have a
distinctive odor potent enough for its presence to be detected down to a
concentration in air of not over \1/5\ (one-fifth) of the lower limit of
flammability. After addition of the odorant, the propane base fuel shall
contain no more than 120 ppm sulfur by weight.
(3) The propane base fuel shall meet the specifications listed in
table F94-6.
Table F94-6--Propane Base Fuel Specifications
------------------------------------------------------------------------
------------------------------------------------------------------------
Vapor pressure at 100-F, psig, max.............................. 208
Evaporative temperature, 95%, [deg]F, max....................... -37
Propane, vol%, min.............................................. 92.5
Propylene, vol%, max............................................ 5.0
Butane and heavier, vol%, max................................... 2.5
Residue-evaporation of 100mL, max, mL........................... 0.05
Sulfur (including odorant additive) ppmw, max................... 123
------------------------------------------------------------------------
Sec. 79.56 Fuel and fuel additive grouping system.
(a) Manufacturers of fuels and fuel additives are allowed to satisfy
the testing requirements in Sec. Sec. 79.52, 79.53, and 79.54 and the
associated reporting requirements in Sec. 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 Sec. 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.
[[Page 37]]
(1) The use of the grouping provision to comply with Tier 1 and Tier
2 testing requirements is voluntary. 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.
(2) The only groups permitted are those established in this section.
(b) Each manufacturer who chooses to enroll a fuel or fuel additive
in a group of similar fuels and fuel additives as designated in this
section may satisfy the registration requirements through a group
submission of jointly-sponsored testing and analysis conducted on a
product which is representative of all products in that group, provided
that the group representative is chosen according to the specifications
in this section.
(1) The health effects information submitted by a group shall be
considered applicable to all fuels and fuel additives in the group. A
fuel or fuel additive manufacturer who has chosen to participate in a
group may subsequently choose to perform testing of such fuel or fuel
additive on an individual basis; however, until such independent
registration information has been received and reviewed by EPA, the
information initially submitted by the group on behalf of the
manufacturer's fuel or fuel additive shall be considered applicable and
valid for that fuel or fuel additive. It could therefore be used to
support requirements for further testing under the provisions of Tier 3
or to support regulatory decisions affecting that fuel or fuel additive.
(2) Manufacturers are responsible for determining the appropriate
groups for their products according to the criteria in this section and
for enrolling their products into those groups under industry-sponsored
or other independent brokering arrangements.
(3) Manufacturers who enroll a fuel or fuel additive into a group
shall share the applicable costs according to appropriate arrangements
established by the group. The organization and administration of group
functions and the development of cost-sharing arrangements are the
responsibility of the participating manufacturers. If manufacturers are
unable to agree on fair and equitable cost sharing arrangements and if
such dispute is referred by one or more manufacturers to EPA for
resolution, then the provisions in Sec. 79.56(c) (1) and (2) shall
apply.
(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 Sec. 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).
[[Page 38]]
(d) Basis for classification. (1) Rather than segregating fuels and
fuel additives into separate groups, the grouping system applies the
same grouping criteria and creates a single set of groups applicable
both to fuels and fuel additives.
(2) Fuels shall be classified pursuant to Sec. 79.56(e) into
categories and groups of similar fuels and fuel additives according to
the components and characteristics of such fuels in their uncombusted
state. The classification of a fuel product must take into account the
components of all bulk fuel additives which are listed in the
registration application or basic registration data submitted for the
fuel product.
(3) Fuel additives shall be classified pursuant to Sec. 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 Sec. 79.51(h)(1).
(4) In determining the category and group to which a fuel or fuel
additive belongs, impurities present in trace amounts shall be ignored
unless otherwise noted. Impurities are those substances which are
present through contamination or which remain in the fuel or additive
naturally after processing is completed.
(5) Reference standards. (i) American Society for Testing and
Materials (ASTM) standard D 4814-93a, ``Standard Specification for
Automotive Spark-Ignition Engine Fuel'', used to define the general
characteristics of gasoline fuels (paragraph (e)(3)(i)(A)(3) of this
section) and ASTM standard D 975-93, ``Standard Specification for Diesel
Fuel Oils'', used to define the general characteristics of diesel fuels
(paragraph (e)(3)(ii)(A)(3) of this section) have been incorporated by
reference.
(ii) This incorporation by reference was approved by the Director of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Copies may be obtained from the American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103. Copies may
be inspected at U.S. EPA, OAR, 401 M Street SW., Washington, DC 20460 or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(e) Grouping criteria. The grouping system is represented by a
matrix of three fuel/additive categories within six specified fuel
families (see table F94-7, Grouping System for Fuels and Fuel
Additives). Each category may include one or more groups. Within each
group, a representative may be designated based on the criteria in this
section and joint registration information may be developed and
submitted for member fuels and fuel additives.
[[Page 39]]
Table F94-7--Grouping System for Fuels and Fuel Additives
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conventional Fuel Families Alternative Fuel Families
-----------------------------------------------------------------------------------------------------------------------
Category Methane (CNG, LNG)
Gasoline (A) Diesel (B) Methanol (C) Ethanol (D) (E) Propane (LPG) (F)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline........................ One group One group Two groups: (1) One group One group One group
represented by represented by M100 group (includes ethanol- (includes both represented by
gasoline base diesel base fuel. (includes gasoline CNG and LNG), LPG base fuel.
fuel. methanol-gasoline formulations with represented by
formulations with at least 50% CNG base fuel.
at least 96% ethanol)
methanol) represented by
represented by E85 base fuel.
M100 base fuel
(2) M85 (includes
methanol-gasoline
formulations with
50-95% methanol)
represented by
M85 base fuel.
Non-baseline.................... One group for each One group for each One group for each One group for each One group to One group to
gasoline- oxygen- individual non- individual non- include methane include propane
oxygenate blend contributing methanol, non- ethanol, non- formulations formulations
or each gasoline- compound or class gasoline gasoline exceeding the exceeding the
methanol/co- of compounds; one component and one component and one specified limit specified limit
solvent blend; group for each group for each group for each for non-methane for butane and
one group for synthetic crude- unique unique hydrocarbons. higher
each synthetic derived fuel. combination of combination of hydrocarbons.
crude-derived such components. such components.
fuel.
Atypical........................ One group for each One group for each One group for each One group for each One group for each One group for each
atypical element/ atypical element/ atypical element/ atypical element/ atypical element/ atypical element/
characteristic, characteristic, characteristic, characteristic, characteristic, characteristic,
or unique or unique or unique or unique or unique or unique
combination of combination of combination of combination of combination of combination of
atypical elements/ atypical elements/ atypical elements/ atypical elements/ atypical elements/ atypical elements/
characteristics. characteristics. characteristics. characteristics. characteristics. characteristics.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Fuel families. Each of the following six fuel families (Table
F94-7, columns A-F) includes fuels of the type referenced in the name of
the family as well as bulk and aftermarket additives which are intended
for use in those fuels. When applied to fuel additives, the criteria in
these descriptions refer to the associated additive/base fuel mixture,
pursuant to Sec. 79.51(h)(1). One or more base fuel formulations are
specified for each fuel family pursuant to Sec. 79.55.
(i) The Gasoline Family includes fuels composed of more than 50
percent gasoline by volume and their associated fuel additives. The base
fuel for this family is specified in Sec. 79.55(b).
(ii) The Diesel Family includes fuels composed of more than 50
percent diesel fuel by volume and their associated fuel additives. The
Diesel fuel family includes both Diesel 1 and Diesel 2 formulations.
The base fuel for this family is specified in Sec. 79.55(c).
(iii) The Methanol Family includes fuels composed of at least 50
percent methanol by volume and their associated fuel additives. The M100
and M85 base fuels are specified in Sec. 79.55(d).
(iv) The Ethanol Family includes fuels composed of at least 50
percent ethanol by volume and their associated fuel additives. The base
fuel for this family is E85 as specified in Sec. 79.55(e).
(v) The Methane Family includes compressed natural gas (CNG) and
liquefied natural gas (LNG) fuels containing at least 50 mole percent
methane and their associated fuel additives. The base fuel for the
family is a CNG formulation specified in Sec. 79.55(f).
[[Page 40]]
(vi) The Propane Family includes propane fuels containing at least
50 percent propane by volume and their associated fuel additives. The
base fuel for this family is a liquefied petroleum gas (LPG) as
specified in Sec. 79.55(g).
(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 Sec.
79.59(a)(1) for further guidance in classifying and testing such
formulation(s).
(2) Fuel/additive categories. Fuel/additive categories (Table F94-7,
rows 1-3) are subdivisions of fuel families which represent the degree
to which fuels and fuel additives in the family resemble the base
fuel(s) designated for the family. Three general category types are
defined in this section. When applied to fuel additives, the criteria in
these descriptions refer to the associated additive/base fuel mixture,
pursuant to Sec. 79.51(h)(1).
(i) Baseline categories consist of fuels and fuel additives which
contain no elements other than those permitted in the base fuel for the
respective fuel family and conform to specified limitations on the
amounts of certain components or characteristics applicable to that fuel
family.
(ii) Non-Baseline Categories consist of fuels and fuel additives
which contain no elements other than those permitted in the base fuel
for the respective fuel family, but which exceed one or more of the
limitations for certain specified components or characteristics
applicable to baseline formulations in that fuel family.
(iii) Atypical Categories consist of fuels and fuel additives which
contain elements or classes of compounds other than those permitted in
the base fuel for the respective fuel family or which otherwise do not
meet the criteria for either baseline or non-baseline formulations in
that fuel family. A fuel or fuel additive product having both non-
baseline and atypical characteristics pursuant to Sec. 79.56(e)(3),
shall be considered to be an atypical product.
(3) This section defines the specific categories applicable to each
fuel family. When applied to fuel additives, the criteria in these
descriptions refer to the associated additive/base fuel mixture,
pursuant to Sec. 79.51(h)(1).
(i) Gasoline Categories. (A) The Baseline Gasoline category contains
gasoline fuels and associated additives which satisfy all of the
following criteria:
(1) Contain no elements other than carbon, hydrogen, oxygen,
nitrogen, and/or sulfur.
(2) Contain less than 1.5 percent oxygen by weight.
(3) Sulfur concentration is limited to 1000 ppm per the
specifications cited in the following paragraph.
(4) Possess the physical and chemical characteristics of unleaded
gasoline as specified by ASTM standard D 4814-93a (incorporated by
reference, pursuant to paragraph (d)(5) of this section), in at least
one Seasonal and Geographical Volatility Class.
(5) Derived only from conventional petroleum, heavy oil deposits,
coal, tar sands, and/or oil sands.
(B) The Non-Baseline Gasoline category is comprised of gasoline
fuels and associated additives which conform to the specifications in
paragraph (e)(3)(i)(A) of this section for the Baseline Gasoline
category except that they contain 1.5 percent or more oxygen by weight
and/or may be derived from sources other than those listed in paragraph
(e)(3)(i)(A)(5) of this section.
(C) The Atypical Gasoline category is comprised of gasoline fuels
and associated additives which contain one or more elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur.
(ii) Diesel Categories. (A) The Baseline Diesel category is
comprised of diesel fuels and associated additives which satisfy all of
the following criteria:
(1) Contain no elements other than carbon, hydrogen, oxygen,
nitrogen, and/or sulfur. Pursuant to 40 CFR 80.29, highway diesel sold
after October 1, 1993 shall contain 0.05 percent or less sulfur by
weight;
(2) Contain less than 1.0 percent oxygen by weight;
(3) Diesel formulations containing more than 0.05 percent sulfur by
weight are precluded by 40 CFR 80.29;
(4) Possess the characteristics of diesel fuel as specified by ASTM
standard D 975-93 (incorporated by reference,
[[Page 41]]
pursuant to paragraph (d)(5) of this section); and
(5) Derived only from conventional petroleum, heavy oil deposits,
coal, tar sands, and/or oil sands.
(B) The Non-Baseline Diesel category is comprised of diesel fuels
and associated additives which conform to the specifications in
paragraph (e)(3)(ii)(A) of this section for the Baseline Diesel category
except that they contain 1.0 percent or more oxygen by weight and/or may
be derived from sources other than those listed in paragraph
(e)(3)(ii)(A)(5) of this section.
(C) The Atypical Diesel category is comprised of diesel fuels and
associated additives which contain one or more elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur.
(iii) Methanol categories. (A) The Baseline Methanol category is
comprised of methanol fuels and associated additives which contain at
least 50 percent methanol by volume, no more than 4.0 percent by volume
of substances other than methanol and gasoline, and no elements other
than carbon, hydrogen, oxygen, nitrogen, sulfur, and/or chlorine.
Baseline methanol shall contain no more than 0.004 percent by weight of
sulfur or 0.0001 percent by weight of chlorine.
(B) The Non-Baseline Methanol category is comprised of fuel blends
which contain at least 50 percent methanol by volume, more than 4.0
percent by volume of a substance(s) other than methanol and gasoline,
and meet the baseline limitations on elemental composition in paragraph
(e)(3)(iii)(A) of this section.
(C) The Atypical Methanol category consists of methanol fuels and
associated additives which do not meet the criteria for either the
Baseline or the Non-Baseline Methanol category.
(iv) Ethanol categories. (A) The Baseline Ethanol category is
comprised of ethanol fuels and associated additives which contain at
least 50 percent ethanol by volume, no more than five (5) percent by
volume of substances other than ethanol and gasoline, and no elements
other than carbon, hydrogen, oxygen, nitrogen, sulfur, chlorine, and
copper. Baseline ethanol formulations shall contain no more than 0.004
percent by weight of sulfur, 0.0004 percent by weight of chlorine, and/
or 0.07 mg/L of copper.
(B) The Non-Baseline Ethanol category is comprised of fuel blends
which contain at least 50 percent ethanol by volume, more than five (5)
percent by volume of a substance(s) other than ethanol and gasoline, and
meet the baseline limitations on elemental composition in paragraph
(e)(3)(iv)(A) of this section.
(C) The Atypical Ethanol category consists of ethanol fuels and
associated additives which do not meet the criteria for either the
Baseline or the Non-Baseline Ethanol categories.
(v) Methane categories. (A) The Baseline Methane category is
comprised of methane fuels and associated additives (including at least
an odorant additive) which contain no elements other than carbon,
hydrogen, oxygen, nitrogen, and/or sulfur, and contain no more than 20
mole percent non-methane hydrocarbons. Baseline methane formulations
shall not contain more than 16 ppm by volume of sulfur, including any
sulfur which may be contributed by the odorant additive.
(B) The Non-Baseline Methane category consists of methane fuels and
associated additives which conform to the specifications in paragraph
(e)(3)(v)(A) of this section for the Baseline Methane category except
that they exceed 20 mole percent non-methane hydrocarbons.
(C) The Atypical Methane category consists of methane fuels and
associated additives which contain one or more elements other than
carbon, hydrogen, oxygen, nitrogen, and/or sulfur, or exceed 16 ppm by
volume of sulfur.
(vi) Propane categories. (A) The Baseline Propane category is
comprised of propane fuels and associated additives (including at least
an odorant additive) which contain no elements other than carbon,
hydrogen, oxygen, nitrogen, and/or sulfur, and contain no more than 20
percent by volume non-propane hydrocarbons. Baseline Propane
formulations shall not contain more than 123 ppm by weight of sulfur,
including any sulfur which may be contributed by the odorant additive.
(B) The Non-Baseline Propane category consists of propane fuels and
associated additives which conform to
[[Page 42]]
the specifications in paragraph (e)(3)(vi)(A) of this section for the
Baseline Propane category, except that they exceed the 20 percent by
volume limit for butane and higher hydrocarbons.
(C) The Atypical Propane category consists of propane fuels and
associated additives which contain elements other than carbon, hydrogen,
oxygen, nitrogen, and/or sulfur, or exceed 123 ppm by weight of sulfur.
(4) Fuel/additive groups. Fuel/additive groups are subdivisions of
the fuel/additive categories. One or more group(s) are defined within
each category in each fuel family according to the presence of differing
characteristics in the fuel or additive/base fuel mixture. For each
group, one formulation (either a base fuel or a member fuel or additive
product) is chosen to represent all the member products in the group in
any tests required under this subpart. The section which follows
describes the fuel/additive groups.
(i) Baseline groups. (A) The Baseline Gasoline category comprises a
single group. The gasoline base fuel specified in Sec. 79.55(b) shall
serve as the representative of this group.
(B) The Baseline Diesel category comprises a single group. The
diesel base fuel specified in Sec. 79.55(c) shall serve as the
representative of this group.
(C) The Baseline Methanol category includes two groups: M100 and
M85. The M100 group consists of methanol-gasoline formulations
containing at least 96 percent methanol by volume. These formulations
must contain odorants and bitterants (limited in elemental composition
to carbon, hydrogen, oxygen, nitrogen, sulfur, and chlorine) for
prevention of purposeful or inadvertent consumption. The M100 base fuel
specified in Sec. 79.55(d) shall serve as the representative for this
group. The M85 group consists of methanol-gasoline formulations
containing at least 50 percent by volume but less than 96 percent by
volume methanol. The M85 base fuel specified in Sec. 79.55(d) shall
serve as the representative of this group.
(D) The Baseline Ethanol category comprises a single group. The E85
base fuel specified in Sec. 79.55(e) shall serve as the representative
of this group.
(E) The Baseline Methane category comprises a single group. The CNG
base fuel specified in Sec. 79.55(f) shall serve as the representative
of this group.
(F) The Baseline Propane category comprises a single group. The LPG
base fuel specified in Sec. 79.55(g) shall serve as the representative
of this group.
(ii) Non-baseline groups--(A) Non-Baseline Gasoline. 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
[[Page 43]]
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 Sec. 79.51(i), non-baseline gasoline products may
belong to more than one fuel/additive group.
(B) Non-Baseline Diesel. The Non-Baseline diesel fuels and
associated additives shall sort into groups according to the following
criteria:
(1) For diesel fuel and additive products which contain 1.0 percent
or more oxygen by weight in the form of alcohol(s) and/or ether(s):
(i) A separate non-baseline diesel group shall be defined by each
individual alcohol or ether listed as a component in the registration
application or basic registration data of any such fuel or additive.
(ii) For each such group, the representative to be used in testing
shall be a formulation consisting of the diesel base fuel blended with
the relevant alcohol or ether in an amount equivalent to the highest
actual or recommended concentration-in-use of the alcohol or ether
recorded in the basic registration data of any member fuel or additive
product.
(2) A separate non-baseline diesel group is also defined for each of
the following classes of oxygenating compounds: mixed nitroso-compounds;
mixed nitro-compounds; mixed alkyl nitrates; mixed alkyl nitrites;
peroxides; furans; mixed alkyl esters of plant and/or animal origin
(biodiesel). For each such group, the representative to be used in
testing shall be formulated as follows:
(i) From the class of compounds which defines the group, a
particular oxygenate compound shall be chosen from among all such
compounds recorded in the registration application or basic registration
data of any fuel or additive in the group.
(ii) The selected compound shall be the one recorded in any member
product's registration application with the highest actual or
recommended maximum concentration-in-use.
(iii) In the event that two or more oxygenate compounds in the
relevant class have the highest recorded concentration-in-use, then the
oxygenate compound to be used in the group representative shall be
chosen at random from the qualifying candidate compounds.
(iv) The compound thus selected shall be the group representative,
and shall be used in testing at the following concentration:
(A) For biodiesel groups, the representative shall be 100 percent
biodiesel fuel.
(B) Otherwise, the group representative shall be the selected
compound mixed into diesel base fuel at the maximum recommended
concentration-in-use.
(3) Separate non-baseline diesel groups shall also be defined for
diesel 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.
(ii) In any such group, the first product to be registered or to
apply for
[[Page 44]]
EPA registration shall be the representative of that group. If two or
more products are registered or apply for first registration
simultaneously, then the representative shall be chosen by a random
method from among such candidate products.
(4) Pursuant to Sec. 79.51(i), non-baseline diesel products may
belong to more than one fuel/additive group.
(C) Non-baseline methanol. The Non-Baseline methanol formulations
are sorted into groups based on the non-methanol, non-gasoline
component(s) of the blended fuel. Each such component occurring
separately and each unique combination of such components shall define a
separate group.
(1) The representative of each such non-baseline methanol group
shall be the group member with the highest percent by volume of non-
methanol, non-gasoline component(s).
(2) In case two or more such members have the same and highest
concentration of non-methanol, non-gasoline component(s), the
representative of the group shall be chosen at random from among such
equivalent member products.
(D) Non-Baseline Ethanol. The Non-Baseline ethanol formulations are
sorted into groups based on the non-ethanol, non-gasoline component(s)
of the blended fuel. Each such component occurring separately and each
unique combination of such components shall define a separate group.
(1) The representative of each such non-baseline ethanol group shall
be the group member with the highest percent by volume of non-ethanol,
non-gasoline component(s).
(2) In case two or more such members have the same and highest
concentration of non-ethanol, non-gasoline component(s), the
representative of the group shall be chosen at random from among such
equivalent member products.
(E) Non-Baseline Methane. The Non-Baseline methane category consists
of one group. The group representative shall be the member fuel or fuel/
additive formulation containing the highest concentration-in-use of non-
methane hydrocarbons. If two or more member products have the same and
the highest concentration-in-use, then the representative shall be
chosen at random from such products.
(F) Non-baseline propane. The Non-Baseline propane category consists
of one group. The group representative shall be the member fuel or fuel/
additive formulation containing the highest concentration-in-use of
butane and higher hydrocarbons. If two or more products have the same
and the highest concentration-in-use, then the representative shall be
chosen at random from such products.
(iii) Atypical groups. (A) As defined for each individual fuel
family in Sec. 79.56(e)(3), fuels and additives meeting any one of the
following criteria are considered atypical.
(1) Gasoline Atypical fuels and additives contain one or more
elements in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur.
(2) Diesel Atypical fuels and additives contain one or more element
in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur.
(3) Methanol Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, sulfur, and chlorine, and/or
(ii) sulfur in excess of 0.004 percent by weight, and/or
(iii) chlorine in excess of 0.0001 percent by weight.
(4) Ethanol Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, sulfur, chlorine, and copper, and/or
(ii) sulfur in excess of 0.004 percent by weight, and/or
(iii) contain chlorine (as chloride) in excess of 0.0004 percent by
weight, and/or
(iv) contain copper in excess of 0.07 mg/L.
(5) Methane Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, and sulfur, and/or
(ii) sulfur in excess of 16 ppm by volume.
(6) Propane Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, and sulfur, and/or
[[Page 45]]
(ii) sulfur in excess of 123 ppm by weight.
(B) General rules for sorting these atypical fuels and additives
into separate groups are as follows:
(1) Pursuant to Sec. 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.
(C) Specific rules for sorting each family's atypical fuels and
additives into separate groups, and for choosing each such group's
representative for testing, are as follows:
(1) A separate group is created for each atypical element (or other
atypical characteristic) occurring separately, i.e., in the absence of
any other atypical element or characteristic, in one or more fuels and/
or additives within a given fuel family.
(i) Consistent with the basic grouping guidelines provided in Sec.
79.56(d), a fuel product which is classified as atypical because its
basic registration data or application lists a bulk additive containing
an atypical characteristic, may be grouped with that additive and/or
with other fuels and additives containing the same atypical
characteristic.
(ii) Within a group of products containing only one atypical element
or characteristic, the fuel or additive/base fuel mixture with the
highest concentration-in-use or recommended concentration-in-use of the
atypical element or characteristic shall be the designated
representative of that group. In the event that two or more fuels or
additive/base fuel mixtures within the group contain the same and
highest concentration of the single atypical element or characteristic,
then the group representative shall be selected by a random method from
among such candidate products.
(2) A separate group is also created for each unique combination of
atypical elements (and/or other specified atypical characteristics)
occurring together in one or more fuels and/or additives within a given
fuel family.
(i) Consistent with the basic grouping guidelines provided in Sec.
79.56(d), a fuel which is classified as atypical because its basic
registration data lists one bulk additive containing two or more
atypical characteristics, may be grouped with that additive and/or with
other fuels and/or additives containing the same combination of atypical
characteristics. Grouping of fuels containing more than one atypical
additive shall be guided by provisions of Sec. 79.51(j).
(ii) Within a group of such products containing a unique combination
of two or more atypical elements or characteristics, the designated
representative shall be the product within the group which contains the
highest total concentration of the atypical elements or characteristics.
(iii) In the event that two or more products within a given atypical
group contain the same and highest concentration of the same atypical
elements or characteristics then, among such candidate products, the
designated representative shall be the product which, first, has the
highest total concentration of metals, followed in order by highest
total concentration of halogens, highest total concentration of other
atypical elements (including sulfur concentration, as applicable),
highest total concentration of polymers containing atypical elements,
and, lastly, highest total concentration of oxygen.
(iv) If two or more products have the same and highest concentration
of the variable identified in the preceding paragraph, then, among such
products, the one with the greatest concentration of the next highest
variable on the list shall be the group representative.
(v) This decision-making process shall continue until a single
product is determined to be the representative. If two or more products
remain tied at
[[Page 46]]
the end of this process, then the representative shall be chosen by a
random method from among such remaining products.
[59 FR 33093, June 27, 1994, as amended at 62 FR 12571, Mar. 17, 1997]
Sec. 79.57 Emission generation.
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
Sec. Sec. 79.52(b) and 79.53 of these regulations. When applicable,
they may also be required in conjunction with testing under Sec. Sec.
79.54 and 79.58(c). Additional requirements concerning emission
generation, delivery, dilution, quality control, and safety practices
are outlined in Sec. 79.61.
(a) Vehicle and engine selection criteria. (1) All vehicles and
engines used to generate emissions for testing a fuel or additive/fuel
mixture must be new (i.e., never before titled) and placed into the
program with less than 500 miles on the odometer or 12 hours on the
engine chronometer. The vehicles and engines shall be unaltered from the
specifications of the original equipment manufacturer.
(2) The vehicle/engine type, vehicle/engine class, and vehicle/
engine subclass designated to generate emissions for a given fuel or
additive shall be the same type, class, and subclass which, over the
previous three years, has consumed the most gallons of fuel in the fuel
family applicable to the given fuel or additive. No distinction shall be
made between light-duty vehicles and light-duty trucks for purposes of
this classification.
(3) Within this vehicle/engine type, class, and subclass, the
specific vehicles and engines acceptable for emission generation are
those that represent the most common fuel metering system and the most
common of the most important emission control system devices or
characteristics with respect to emission reduction performance for the
model year in which testing begins. These vehicles will be determined
through a survey of the previous model year's vehicle/engine sales
within the given subclass. These characteristics shall include, but need
not be limited to, aftertreatment device(s), fuel aspiration, air
injection, exhaust gas recirculation, and feedback type.
(4) Within the applicable subclass, the five highest selling
vehicle/engine models that contain the most common such equipment and
characteristics shall be determined. Any of these five models of the
current model year (at the time testing begins) may be selected for
emission generation.
(i) If one or more of the five models is not available for the
current model year, the choice of model for emission generation shall be
limited to those remaining among the five.
(ii) If fewer than five models of the given vehicle/engine type are
available for the current model year, all such models shall be eligible.
(5) When the fuel or fuel additive undergoing testing is not
commonly used or intended to be used in the vehicle/engine types
prescribed by this selection procedure, or when rebuilding or alteration
is required to obtain a suitable vehicle/engine for emission generation,
the manufacturer may submit a request to EPA for a modification in test
procedure requirements. Any such request must include objective test
results which support the claim that a more appropriate vehicle/engine
type is needed as well as a suggested substitute vehicle/engine type.
The vehicle/engine selection in this case shall be approved by EPA prior
to the start of testing.
(6) Once a particular model has been chosen on which to test a fuel
or additive product, all mileage accumulation and generation of
emissions for characterization and biological testing of such product
shall be conducted on that same model.
(i) If the initial test vehicle/engine fails or must be replaced for
any reason, emission generation shall continue with a second vehicle/
engine which is identical to, or resembles to the greatest extent
possible, the initial test vehicle/engine. If more than one replacement
vehicle/engine is necessary, all such vehicles/engines shall be
identical, or resemble to the greatest extent possible, the initial test
vehicle/engine.
(ii) Manufacturers are encouraged to obtain, at the start of a test
program,
[[Page 47]]
more than one emission generation vehicle/engine of the identical model,
to ensure the availability of back-up emission generator(s). All backup
vehicles/engines must be conditioned and must have their emissions fully
characterized, as done for the initial test vehicle/engine, prior to
their use as emission generators for biological testing. Alternating
between such vehicles/engines regularly during the course of testing is
permissible and advisable, particularly to allow regular maintenance on
such vehicles/engines during prolonged health effects testing.
(b) Vehicle/engine operation and maintenance. (1) For the purpose of
generating combustion emissions from a fuel or additive/base fuel
mixture for which the relevant class is light duty, either a light-duty
vehicle shall be operated on a chassis dynamometer or a light-duty
engine shall be operated on an engine dynamometer. When the relevant
class is heavy duty, the emissions shall be generated on a heavy-duty
engine operated on an engine dynamometer. In both cases, the vehicle or
engine model shall be selected as described in paragraph (a) of this
section and shall have all applicable fuel and emission control systems
intact.
(2) Except as provided in Sec. 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 Sec.
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 Sec.
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 [deg]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 [deg]F shall be
performed repeatedly as necessary to achieve canister breakthrough. The
fuel tank must be drained and filled prior to each heat build.
(3) Scheduled and unscheduled vehicle/engine maintenance. (i) During
emission generation, vehicles and engines must be maintained in good
condition by following the recommendations of the original equipment
manufacturer (OEM) for scheduled service and parts replacement, with
repairs performed only as necessary. Modifications, adjustments, and
maintenance procedures contrary to procedures found in 40 CFR part 86
for the maintenance of test vehicles/engines or performed solely for the
purpose of emissions improvement are not allowed.
(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
[[Page 48]]
pursuant to Sec. 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.
(c) Mileage accumulation. (1) A vehicle/engine break-in period is
required prior to generating emissions for characterization and/or
biological testing under this subpart. The required mileage accumulation
may be accomplished on a test track, on the street, on a dynamometer, or
using any other conventionally accepted method.
(2) Vehicles to be used in the evaluation of baseline and non-
baseline fuels and fuel additives shall accumulate 4,000 miles prior to
emission testing. Engines to be used in the evaluation of baseline and
non-baseline fuels and fuel additives shall accumulate 125 hours of
operation on an engine dynamometer prior to emission testing.
(3) When the test formulation is classified as an atypical fuel or
fuel additive formulation (pursuant to definitions in Sec.
79.56(e)(4)(iii)), the following additional mileage accumulation
requirements apply:
(i) The test vehicle/engine must be operated for a minimum of 4,000
vehicle miles or 125 hours of engine operation.
(ii) Thereafter, at intervals determined by the tester, all emission
fractions (i.e., vapor, semi-volatile, and particulate) shall be sampled
and analyzed for the presence and amount of the atypical element(s) and/
or other atypical constituents. Pursuant to paragraph (d) of this
section, the sampled emissions must be generated in the absence of an
intact aftertreatment device. Immediately before the samples are taken,
a brief warmup period (at least ten miles or the engine equivalent) is
required.
(iii) Mileage accumulation shall continue until either 50 percent or
more of the mass of each atypical element (or other atypical
constituent) entering the engine can be measured in the exhaust
emissions (all fractions combined), or the vehicle/engine has
accumulated mileage (or hours) equivalent to 40 percent of the average
useful life of the applicable vehicle/engine class (pursuant to
regulations in 40 CFR part 86). For example, the maximum mileage
required for light-duty vehicles is 40 percent of 100,000 miles (i.e.,
40,000 miles), while the maximum time of operation for heavy-duty
engines is the equivalent of 40 percent of 290,000 miles (i.e., the
equivalent in engine hours of 116,000 miles).
(iv) When either condition in paragraph (c)(3)(iii) of this section
has been reached, additional emission characterization and biological
testing of the emissions may begin.
(d) Use of exhaust aftertreatment devices. (1) If the selected test
vehicle/engine, as certified by EPA, does not come equipped with an
emissions aftertreatment device (such as a catalyst or particulate
trap), such device shall not be used in the context of this program.
(2) Except as provided in paragraph (d)(3) of this section for
certain specialized additives, the following provisions apply when the
test vehicle/engine, as certified by EPA, comes equipped with an
emissions aftertreatment device.
(i) For mileage accumulation:
(A) When the test formulation does not contain any atypical elements
(pursuant to definitions in Sec. 79.56(e)(4)(iii)), an intact
aftertreatment device must be used during mileage accumulation.
(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 Sec. 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
[[Page 49]]
memorandum of exemption for product testing must be obtained by applying
to the Director of the Field Operations and Support Division (see Sec.
79.59(a)(1)).
(2) [Reserved]
(ii) For Tier 1 (Sec. 79.52), the total set of requirements for the
characterization of combustion emissions (Sec. 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.
(iii) For Tier 2 (Sec. 79.53), the standard requirements for
biological testing of combustion emissions shall be conducted using
emissions generated with a non-functioning aftertreatment device as
described in paragraph (d)(2)(i)(B) of this section.
(iv) For alternative Tier 2 requirements (Sec. 79.58(c)) or Tier 3
requirements (Sec. 79.54) which may be prescribed by EPA, the use of
functional or nonfunctional aftertreatment devices shall be specified by
EPA as part of the test guidelines.
(v) In the case where an intact aftertreatment device is not in
place, all other manufacturer-specified combustion characteristics
(e.g., back pressure, residence time, and mixing characteristics) of the
altered vehicle/engine shall be retained to the greatest extent
possible.
(3) Notwithstanding paragraphs (d)(1) and (d)(2) of this section,
when the subject of testing is a fuel additive specifically intended to
enhance the effectiveness of exhaust aftertreatment devices, the related
aftertreatment device may be used on the emission generation vehicle/
engine during all mileage accumulation and testing.
(e) Generation of combustion emissions--(1) Generating combustion
emissions for emission characterization. (i) Combustion emissions shall
be generated according to the exhaust emission portion of the Federal
Test Procedure (FTP) for the certification of new motor vehicles, found
in 40 CFR part 86, subpart B for light-duty vehicles/engines, and
subparts D, M and N for heavy-duty vehicles/engines. The Urban
Dynamometer Driving Schedule (UDDS), pursuant to 40 CFR part 86,
appendix I(a), shall apply to light-duty vehicles/engines and the Engine
Dynamometer Driving Schedule (EDS), pursuant to 40 CFR part 86, appendix
I(f)(2), shall apply to heavy-duty vehicles/engines. The motoring
portion of the heavy-duty test cycle may be eliminated, at the
manufacturer's option, for the generation of emissions.
(A) For light-duty engines operated on an engine dynamometer, the
tester shall determine the speed-torque equivalencies (``trace'') for
its test engine from valid FTP testing performed on a chassis
dynamometer, using a test vehicle with an engine identical to that being
tested. The test engine must then be operated under these speed and
torque specifications to simulate the FTP cycle.
(B) Special procedures not included in the FTP may be necessary in
order to characterize emissions from fuels and fuel additives containing
atypical elements or to collect some types of emissions (e.g.,
particulate emissions from light-duty vehicles/engines, semi-volatile
emissions from both light-duty and heavy-duty vehicles/engines). Such
alterations to the FTP are acceptable.
(C) For Tier 2 testing, the engines shall operate on repeated bags 2
and 3 of the UDDS or back to back repeats of the heavy-duty transient
cycle of the EDS.
(ii) Pursuant to Sec. 79.52(b)(1)(i) and Sec. 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.
(iii) From both light-duty and heavy-duty vehicles/engines, samples
of vapor phase, semi-volatile phase, and particulate phase emissions
shall be collected, except that semi-volatile phase, and particulate
emissions need not be sampled for fuels and additives in the
[[Page 50]]
methane and propane families (pursuant to Sec. 79.56(e)(1)(v) and
(vi)). The number and type of samples to be collected and separately
analyzed during one emission generation/characterization process are as
follows:
(A) In the case of combustion emissions generated from light-duty
vehicles/engines, the samples consist of three bags of vapor emissions
(one from each segment of the light-duty exhaust emission cycle) plus
one sample of particulate-phase emissions and one sample of semi-
volatile-phase emissions (collected over all segments of the exhaust
emission cycle). If the mass of particulate emissions or semi-volatile
emissions obtained during one driving cycle is not sufficient for
characterization, up to three driving cycles may be performed and the
extracted fractions combined prior to chemical analysis. Particulate-
phase emissions shall not be combined with semi-volatile-phase
emissions. The test laboratory should focus on the characterization of
the limit of detection for particulates and semi-volatile emissions.
(B) In the case of combustion emissions generated from heavy-duty
engines, the samples consist of one sample of each emission phase
(vapor, particulate, and semi-volatile) collected over the entire cold-
start cycle and a second sample of each such phase collected over the
entire hot-start cycle (see 40 CFR 86.334 through 86.342).
(iv) Emission collection and storage. (A) Vapor phase emissions
shall be collected and stored in Tedlar bags for subsequent chemical
analysis. Storage conditions are specified in Sec. 79.52(b)(2).
(B) Particulate phase emissions shall be collected on a particulate
filter (or more than one, if required) using methods described in 40 CFR
86.1301 through 86.1344. These methods, ordinarily applied only to
heavy-duty emissions, are to be adapted and used for collection of
particulates from light-duty vehicles/engines, as well. The particulate
matter may be stored on the filter in a sealed container, or the soluble
organic fraction may be extracted and stored in a separate sealed
container. Both the particulate and the extract shall be shielded from
ultraviolet light and stored at -20 [deg]C or less. Particulate
emissions shall be tested no later than six months from the date they
were generated.
(C) Semi-volatile emissions shall be collected immediately
downstream from the particulate collection filters using porous polymer
resin beds, or their equivalent, designed for their capture. The soluble
organic fraction of semi-volatile emissions shall be extracted
immediately and tested within six months of being generated. The extract
shall be stored in a sealed container which is shielded from ultraviolet
light and stored at -20 [deg]C or less.
(D) Particulate and semi-volatile phase emission collection,
handling and extraction methods shall not alter the composition of the
collected material, to the extent possible.
(v) Additional requirements for combustion emission sampling,
storage, and characterization are specified in Sec. 79.52(b).
(2) Generating whole combustion emissions for biological testing.
(i) Biological tests requiring whole combustion emissions shall be
conducted using emissions generated from the test vehicle or engine
operated in accordance with general FTP requirements.
(ii) Light-duty test vehicles/engines shall be repeatedly operated
over the Urban Dynamometer Driving Schedule (UDDS) (or equivalent engine
dynamometer trace, per paragraph (e)(1)(i)(A) of this section) and
heavy-duty test engines shall be repeatedly operated over the Engine
Dynamometer Schedule (EDS) (see 40 CFR part 86, appendix I).
(A) The tolerances of the driving cycle shall be two times those of
the Federal Test Procedure and must be met 95 percent of the time.
(B) The UDDS or EDS shall be repeated as many times as required for
the biological test session.
(C) Light-duty dynamometers shall be calibrated prior to the start
of a biological test (40 CFR 86.118-78), verified weekly (40 CFR 86.118-
78), and recalibrated as required. Heavy-duty dynamometers shall be
calibrated and checked prior to the start of a biological test (40 CFR
86.1318-84), recalibrated every two weeks (40 CFR 86.1318-84(a)) and
checked as stated in 40 CFR 86.1318-84(b) and (c).
[[Page 51]]
(D) The fuel reservoir for the test vehicle/engine shall be large
enough to operate the test vehicle/engine throughout the daily
biological exposure period, avoiding the need for refueling during
testing.
(iii) An apparatus to integrate the large concentration swings
typical of transient-cycle exhaust is to be used between the source of
emissions and the exposure chamber containing the animal test cages(s).
The purpose of such apparatus is to decrease the variability of the
biological exposure atmosphere and achieve the necessary concentration
of CO or NOX, whichever is limiting.
(A) A large mixing chamber is suggested for this purpose. The mixing
chamber would be charged from the CVS at a constant rate determined by
the exposure chamber purge rate. Flow to the exposure chamber would
begin at the conclusion of the initial transient cycle with the
associated mixing chamber charge.
(B) A potential alternative apparatus is a mini-diluter (see, for
example, AIGER/CRADA, February, 1994 in Sec. 79.57(g)).
(C) [Reserved]
(iv) Emission dilution. (A) Dilution air can be pre-dried to lower
the relative humidity, thus permitting a lower dilution rate and a
higher concentration of hydrocarbons to be achieved without condensation
of water vapor.
(B) These procedures include requirements that the mean exposure
concentration in the inhalation test chamber on 90 percent or more of
the exposure days shall be controlled as follows:
(1) If the species being controlled is hydrocarbon or particulate,
the mean exposure concentration must be within 15 percent of the target
concentration for the single species being controlled.
(2) For other species, the mean exposure concentration must be
within 10 percent of the target concentration for the single species
being controlled.
(3) For all species, daily monitoring of CO, CO2,
NOX, SOX, and total hydrocarbons in the exposure
chamber shall be required. Analysis of the particle size distribution
shall also be performed to establish the stability and consistency of
particle size distribution in the test exposure.
(C) After the initial exhaust dilution to preserve the character of
the exhaust, the exhaust stream can be further diluted in the mixing
chamber (and/or after leaving the chamber) to achieve the desired
biological exposure concentrations.
(v) Verification procedures. (A) The entire system used to dilute
and transport whole combustion emissions (i.e., from exhaust pipe to
outlet in the biological testing chamber) shall be verified before any
animal exposures begin, and verified at least weekly during testing.
(See procedures at 40 CFR 86.119-90 for light-duty vehicles and Sec.
86.1319-90 for heavy-duty engines.) Verification testing shall be
accomplished by introducing a known sample at the end of the vehicle/
engine exhaust pipe into the dilution system and measuring the amount
exiting the system. For example, an injected hydrocarbon sample could be
detected with a gas chromatograph (GC) and flame ionization detector
(FID) to determine the recovery factor.
(B) [Reserved]
(vi) Emission exposure quality control. (A) The tester shall
incorporate the additional quality assurance and safety procedures
outlined in Sec. 79.61(d) to control variability of emissions during
the generation of exposure emissions during health effect testing.
(B) These procedures include requirements that the mean exposure
concentration in the inhalation test chamber on 90 percent or more of
the exposure days shall be controlled as follows:
(1) If the species being controlled is hydrocarbon or particulate,
the mean exposure concentration must be within 15 percent of the target
concentration for the single species being controlled.
(2) For other species, the mean exposure concentration must be
within 10 percent of the target concentration for the single species
being controlled.
(3) For all species, daily monitoring of CO, CO2,
NOX, SOX, and total hydrocarbons in the exposure
chamber shall be required. Analysis of the particle size distribution
shall also be performed to establish the stability and consistency of
particle size distribution in the test exposure.
[[Page 52]]
(C) The testing facility shall allow an audit of its premises, the
qualifications, e.g., curriculum vitae, of its staff assigned to
testing, and the specimens and records of the testing for registration
purposes (as specified in Sec. 79.60).
(vii) To allow for customary laboratory scheduling and unforeseen
problems affecting the combustion emission generation or dilution
equipment, biological exposures may be interrupted on limited occasions,
as specified in Sec. 79.61(d)(5). Interruptions exceeding these
limitations shall cause the affected test(s) to be void. Testers shall
be aware of concerns for backup vehicles/engines cited in paragraph
(a)(7)(ii) of this section.
(3) Generating particulate and semi-volatile emissions for
biological testing. (i) Salmonella mutagenicity testing, pursuant to
Sec. 79.68, shall be conducted on extracts of the particulate and semi-
volatile emission phases separately. These emissions shall be generated
by operating the test vehicle/engine over the appropriate FTP driving
schedule (see paragraph (e)(2)(ii) of this section) and collected and
analyzed according to methods described in 40 CFR 86.1301 through 1344
(further information on this subject may be found in Perez, et al. CRC
Report No. 551, 1987 listed in Sec. 79.57(g)).
(A) Particulate emissions shall be collected on particulate filters
and extracted from the collection equipment for use in biological tests.
The number of repetitions of the applicable driving schedule required to
collect sufficient quantities of the particulate emissions will vary,
depending on the characteristics of the engine, the test fuel, and the
requirements of the biological test protocol. The particulate sample may
be collected on one or more filters, as necessary.
(B) Semi-volatile emissions shall be collected immediately
downstream from the particulate collection filters using porous polymer
resin beds, or their equivalent, designed for their capture. Semi-
volatile phase emissions shall be collected on one apparatus. The time
spent collecting sufficient quantities of the test substances in
emissions samples will vary, depending on the emission characteristics
of the engine and fuel or additive/base fuel mixture and on the
requirements of the biological test protocol.
(ii) The extraction method shall be determined by the specifications
of the biological test for which the emissions are used.
(iii) Particulate and semi-volatile emission storage requirements
are as specified in Sec. 79.57(e)(1)(iv).
(iv) Particulate and semi-volatile phase emission collection,
handling and extraction methods shall not alter the composition of the
collected material, to the extent possible.
(v) Particulate emissions shall not be combined with semi-volatile
phase emissions.
(f) Generation of evaporative emissions for characterization and
biological testing. (1) Except as provided in paragraph (f)(5) of this
section, an evaporative emissions generator shall be used to volatilize
samples of a fuel or additive/base fuel mixture for evaporative
emissions characterization and biological testing. Emissions shall be
collected and sampled using equipment and methods appropriate for use
with the compounds being characterized and the requirements of the
emission characterization analysis. In the case of potentially explosive
test substance concentrations, care must be taken to avoid generating
explosive atmospheres. The tester is referred to Sec. 79.61(d)(8) for
considerations involving explosivity.
(2) Evaporative Emissions Generator (EEG) Description. An EEG is a
fuel tank or vessel to which heat is applied causing a portion of the
fuel to evaporate at a desired rate. The manufacturer has flexibility in
designing an EEG for testing a particular fuel or fuel additive. The
sample used to generate emissions in the EEG shall be renewed at least
daily.
(i) The evaporation chamber shall be made from materials compatible
with the fuels and additives being tested and shall be equipped with a
drain.
(ii) The chamber shall be filled to 40 5
percent of its interior volume with the fuel or additive/base fuel
mixture being tested, with the remainder of the volume containing air.
(iii) The concentration of the evaporated fuel or additive/base fuel
mixture in the vapor space of the evaporation
[[Page 53]]
chamber during the time emissions are being withdrawn for testing shall
not vary by more than 10 percent from the equilibrium concentration in
the vapor space of emissions generated from the fresh fuel or additive/
base fuel mixture in the chamber.
(A) During the course of a day's emission generation period, the
level of fuel in the EEG shall be maintained to within 7 percent of its
height at the start of the daily exposure period.
(B) The fuel used in the EEG shall be drained at the end of each
daily exposure. The EEG shall be refilled with a fresh supply of the
test formulation before the start of each daily exposure.
(C) The vapor space of the evaporation chamber shall be well mixed
throughout the time emissions are being withdrawn for testing.
(iv) The size of the evaporation chamber shall be determined by the
rate at which evaporative emissions shall be needed in the test animal
exposure chambers and the rate at which the fuel or the additive/base
fuel mixture evaporates. The rate of evaporative emissions may be
adjusted by altering the size of the EEG or by using one or more
additional EEG(s). Emission rate modifications shall not be adjusted by
temperature control or pressure control.
(v) The temperature of the fuel or additive/base fuel mixture in the
evaporation chamber shall be 130 [deg]F 5 [deg]F.
The vapors shall maintain this temperature up to the point in the system
where the vapors are diluted.
(vi) The pressure in the vapor space of the evaporation chamber and
the dilution and sampling apparatus shall stay within 10 percent of
ambient atmospheric pressure.
(vii) There shall be no controls or equipment on the evaporation
chamber system that change the concentration or composition of the
vapors generated for testing.
(viii) Manufacturers shall perform verification testing of
evaporative emissions in a manner analogous to the verification testing
performed for combustion emissions.
(3) For biological testing, vapor shall be withdrawn from the EEG at
a constant rate, diluted with air as required for the particular study,
and conducted immediately to the biological testing chamber(s) in a
manner similar to the method used in Sec. 79.57(e), excluding the
mixing chamber therein. The rate of emission generation shall be high
enough to supply the biological exposure chamber with sufficient
emissions to allow for a minimum of fifteen air changes per exposure
chamber per hour. To allow for customary laboratory scheduling and for
unforeseen problems with the evaporative emission generation or dilution
equipment, biological exposures may be interrupted on limited occasions,
as specified in Sec. 79.61(d)(5). Interruptions exceeding these
limitations shall cause the affected test(s) to be void.
(4) For characterization of evaporative emissions, samples of
equilibrated emissions to the vapor space of the EEG shall be withdrawn
into Tedlar bags, then stored and analyzed as specified in Sec.
79.52(b).
(5) A manufacturer (or group of manufacturers) may submit to EPA a
request for approval of an alternative method of generating evaporative
emissions for use in emission characterization and biological tests
required under this subpart.
(i) To be approved by EPA, the request must fully explain the
rationale for the proposed method as well as the technical procedures,
quality control, and safety precautions to be used, and must demonstrate
that the proposed method will meet the following criteria:
(A) The emission mixture generated by the proposed procedures must
be reasonably similar to the equilibrium composition of the vapor which
occurs in the vehicle fuel tank head space when the subject fuel or
additive/base fuel mixture is in use and near-maximum in-use
temperatures are encountered.
(B) The emissions mixture generated by the proposed method must be
sufficiently concentrated to provide adequate exposure levels in the
context of the required toxicologic tests.
(C) The proposed method must include procedures to ensure that the
emissions delivered to the biologic exposure chambers will provide a
reasonably constant exposure atmosphere over time.
[[Page 54]]
(ii) If EPA approves the request, EPA will place in the public
record a copy of the request, together with all supporting procedural
descriptions and justifications, and will notify the public of its
availability by publishing a notice in the Federal Register.
(g) References. For additional background information on the
emission generation procedures outlined in this paragraph (g), the
following references may be consulted. Additional references can be
found in Sec. 79.61(f).
(1) AIGER/CRADA (American Industry/Government Emissions Research
Cooperative Research and Development Agreement, ``Specifications for
Advanced Emissions Test Instrumentation'' AIGER PD-94-1, Revision 5.0,
February, 1994
(2) Black, F. and R. Snow, ``Constant Volume Sampling System Water
Condensation'' SAE 940970 in ``Testing and Instrumentation'' SP-1039,
Society of Automotive Engineers, Feb. 28-Mar. 3, 1994.
(3) Perez, J.M., Jass, R.E., Leddy, D.G., eds. ``Chemical Methods
for the Measurement of Unregulated Diesel Emissions (CRC-APRAC Project
No. CAPI-1-64), Coordinating Research Council, CRC Report No. 551,
August, 1987.
(4) Phalen, R.F., ``Inhalation Studies: Foundations and
Techniques'', CRC Press, Inc., Boca Raton, Florida, 1984.
[59 FR 33093, June 27, 1994, as amended at 61 FR 36511, July 11, 1996;
63 FR 63792, Nov. 17, 1998]
Sec. 79.58 Special provisions.
(a) Relabeled Additives. Sellers of relabeled additives (pursuant to
Sec. 79.50) are not required to comply with the provisions of Sec.
79.52, 79.53 or 79.59, except that such sellers are required to comply
with Sec. 79.59(b).
(b) Low Vapor Pressure Fuels and Additives. Fuels which are not
designated as ``evaporative fuels'' and fuel additives which are not
designated as ``evaporative fuel additives'' pursuant to the definitions
in Sec. 79.50 need not undergo the emission characterization or health
effects testing specified in Sec. Sec. 79.52 and 79.53 for evaporative
emissions. At EPA's discretion, the evaporative emissions of such fuels
and additives may be required to undergo Tier 3 testing, pursuant to
Sec. 79.54.
(c) Alternative Tier 2 Provisions. At EPA's discretion, EPA may
modify the standard Tier 2 health effects testing requirements for a
fuel or fuel additive (or group). Such modification may encompass
substitution, addition, or deletion of Tier 2 studies or study
specifications, and/or changes in underlying engine or equipment
requirements, except that a Tier 2 endpoint will not be deleted in the
absence of existing information deemed adequate by EPA or alternative
testing requirements for such endpoint. If warranted by the particular
requirements, EPA will allow additional time for completion of the
alternative Tier 2 testing program.
(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 Sec. 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
[[Page 55]]
standard Tier 2 data and report (pursuant to Sec. 79.59(c)) within one
year of the date on which the toxicology testing began.
(2) EPA will issue a notice in the Federal Register announcing its
intent to require special testing in lieu of or in addition to the
standard Tier 2 testing for a particular fuel or additive manufacturer
or group, and that a copy of the letter to the manufacturer or group
describing the proposed alternative Tier 2 testing for that manufacturer
or group is available in the public record for review and comment. The
public shall have a minimum of 30 days after the publication of this
notice to comment on the proposed alternative Tier 2 testing.
(3) EPA will include in the public record a copy of any timely
comments concerning the proposed alternative Tier 2 testing requirements
received from the affected manufacturer or group or from the public, and
the responses of EPA to such comments. After reviewing all such comments
received, EPA may adopt final alternative Tier 2 requirements by sending
a certified letter describing such final requirements to the
manufacturer or group. In that event, EPA will also issue a notice in
the Federal Register announcing that it has adopted final alternative
Tier 2 requirements and that a copy of the letter adopting the
requirements has been included in the public record.
(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 Sec. 79.51 (c) and (d) for routine Tier 1 and Tier 2
submittals.
(d) Small Business Provisions. (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 Sec.
79.59(b)(2) through (b)(5).
(2) Provisions Applicable to Baseline and Non-baseline Products. A
manufacturer with total annual sales less than $50 million is not
required to meet the requirements of Tier 1 and Tier 2 (specified in
Sec. Sec. 79.52 and 79.53) with regard to such manufacturer's fuel and/
or additive products which meet the criteria for inclusion in a Baseline
or Non-baseline group pursuant to Sec. 79.56. Upon such manufacturer's
satisfactory completion and submittal to EPA of basic registration data
specified in Sec. 79.59(b), the manufacturer may request and EPA shall
issue a registration for such product, subject to Sec. 79.51(c) and
paragraphs (d)(4) and (d)(5) of this section.
(3) Provisions Applicable to Atypical Products. A manufacturer with
total annual sales less than $10 million is not required to meet the
requirements of Tier 2 (specified in Sec. 79.53) in regard to such
manufacturer's fuel and/or additive products which meet the criteria for
inclusion in an Atypical group pursuant to Sec. 79.56. Upon such
manufacturer's satisfactory completion and submittal to EPA of basic
registration data specified in Sec. 79.59(b) and Tier 1 information
specified in Sec. 79.52 for an Atypical fuel or additive, the
manufacturer may request and EPA shall issue a registration for such
product, subject to Sec. 79.51(c) and paragraphs (d)(4) and (d)(5) of
this section. Compliance with Tier 1 requirements under this paragraph
may be accomplished by the individual manufacturer or as a part of a
group pursuant to Sec. 79.56.
(4) Any registration granted by EPA under the provisions of this
section are conditional upon satisfactory completion of any Tier 3
requirements which EPA may subsequently impose pursuant to Sec. 79.54.
In such circumstances, the Tier 3 requirements might include (but would
not necessarily be limited to) information which would otherwise have
been required under the provisions of Tier 1 and/or Tier 2.
(5) The provisions in paragraphs (d)(2) and (d)(3) of this section
are voluntary
[[Page 56]]
on the part of qualifying small manufacturers. Such manufacturers may
choose to fulfill the standard requirements for their fuels and
additives, individually or as a part of a group, rather than satisfying
only the requirements specified in paragraphs (d)(2) and/or (d)(3) of
this section. If a qualifying small manufacturer elects these special
provisions rather than the standard requirements for a product, then EPA
will generally assume that any additional information submitted by other
manufacturers, for fuels and additives meeting the same grouping
criteria (under Sec. 79.56) as that of the small manufacturer's
product, is pertinent to further testing and/or regulatory decisions
that may affect the small manufacturer's product.
(6) In the case of an additive for which the manufacturer is not
required to meet the requirements of Tier 2 pursuant to paragraph (d)(3)
of this section:
(i) A fuel manufacturer which blends such an additive into fuel
shall not be required to meet the requirements of Tier 2 with respect to
such additive/fuel mixture.
(ii) An additive manufacturer which blends such an additive with one
or more other registered additive products and/or with substances
containing only carbon and/or hydrogen shall not be required to meet the
requirements of Tier 2 with respect to such additive or additive blend.
(e) Aftermarket Aerosol Additives. (1) To obtain registration for an
aftermarket aerosol fuel additive, the manufacturer shall provide
existing information in the form of a literature search, a discussion of
the potential exposure(s) to such product, and the basic registration
data specified in Sec. 79.59(b).
(2) The literature search shall include existing data on potential
health and welfare effects due to exposure to the aerosol product itself
and its raw (uncombusted) components. The analysis for potential
exposures shall be based on the actual or anticipated production volume
and market distribution of the particular aerosol product, and its
estimated frequency of use. Other Tier 1 and Tier 2 requirements are not
routinely required for aerosol products. EPA will review the submitted
information and, at EPA's discretion, may require from the manufacturer
further information and/or testing under Tier 3 on a case-by-case basis.
[59 FR 33093, June 27, 1994, as amended at 62 FR 12571, Mar. 17, 1997]
Sec. 79.59 Reporting requirements.
(a) Timing. (1) The manufacturer of each designated fuel or fuel
additive shall submit to EPA the basic registration data detailed in
paragraph (b) of this section. Forms for submitting this data may be
obtained from EPA at the following address: Attn: Fuel/Additives
Registration, U.S. Environmental Protection Agency, 1200 Pennsylvania
Ave., NW, Mail Code 6405A, Washington, DC 20460.
(i) For existing products (pursuant to Sec. 79.51(c)(1)),
manufacturers shall submit the basic registration data as specified in
Sec. 79.59(b) to EPA by November 28, 1994.
(ii) For registrable products (pursuant to Sec. 79.51(c)(2)),
manufacturers shall submit the basic registration data as specified in
Sec. 79.59(b) to apply for registration for such product.
(iii) For new products (pursuant to Sec. 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 Sec. 79.59(b) prior to starting Tiers 1 and 2.
(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 Sec. Sec. 79.52 and 79.53, according to the
time constraints specified in Sec. 79.51 (c) through (d).
(3) The information specified in paragraph (d) of this section shall
be submitted to EPA at the address in paragraph (a)(1) of this section
at the conclusion of activities performed in compliance with Tier 3
under the provisions of Sec. 79.54.
(b) Basic Registration Data. Each manufacturer of a designated fuel
or fuel additive shall submit the following data in regard to such fuel
or fuel additive:
[[Page 57]]
(1) The information specified in Sec. 79.11 or Sec. 79.21. If such
information has already been submitted to EPA in compliance with subpart
B or C of this part, and if such previous information is accurate and
up-to-date, the manufacturer need not resubmit this information.
(2) Annual production volume of the fuel or fuel additive product,
in units of gallons per year if most commonly sold in liquid form or
kilograms per year if most commonly sold in solid form. For fuels and
fuel additives already in production, the most recent annual production
volume and the volume projected to be produced in the third subsequent
year shall be provided. For products not yet in production, the best
estimate of expected annual volume during the third year of production
shall be provided.
(3) Market distribution of the product. For fuels and bulk
additives, this information shall be presented as the percent of total
annual sales volume marketed in each Petroleum Administration for
Defense District (PADD). The States comprising each PADD are listed in
the following section. For aftermarket additives, the distribution data
shall be presented as the percent of total annual sales volume marketed
in each State. For a product not yet in production, the manufacturer
shall present the distribution (by PADD or State, as applicable)
projected to occur during the third year of production.
(i) The following States and jurisdictions are included in PADD I:
Connecticut
Delaware
District of Columbia
Florida
Georgia
Maine
Maryland
Massachusetts
New Hampshire
New Jersey
New York
North Carolina
Pennsylvania
Rhode Island
South Carolina
Vermont
Virginia
West Virginia
(ii) The following States are included in PADD II:
Illinois
Indiana
Iowa
Kansas
Kentucky
Michigan
Minnesota
Missouri
Nebraska
North Dakota
Ohio
Oklahoma
South Dakota
Tennessee
Wisconsin
(iii) The following States are included in PADD III:
Alabama
Arkansas
Louisiana
Mississippi
New Mexico
Texas
(iv) The following States are included in PADD IV:
Colorado
Idaho
Montana
Utah
Wyoming
(v) The following States are included in PADD V:
Alaska
Arizona
California
Hawaii
Nevada
Oregon
Washington
(4) Any applicable information pursuant to the grouping provisions
in Sec. 79.56, as follows:
(i) If the manufacturer has enrolled or intends to enroll the
product in a fuel/additive group, the relevant group and the person(s)
or entity expected to submit information on behalf of the group must be
identified.
(ii) If the manufacturer intends to rely on registration information
previously submitted by another manufacturer (or group) for registration
of other product(s) in the same fuel/additive group, then the original
submitter and its product (or product group) shall be identified. In
such cases, the manufacturer shall provide evidence that the original
submitter has been notified of the use of its registration data and that
the manufacturer has complied or intends to comply with the proportional
reimbursement required under Sec. 79.56(c) of this rule.
(5) Any applicable information pursuant to the special provisions in
Sec. 79.58, as follows:
(i) If the manufacturer claims applicability of the special
provisions for relabeled additives, pursuant to Sec. 79.58(a), then the
manufacturer and brand name of the original product shall be given.
(ii) If the manufacturer claims applicability of any small business
provisions pursuant to Sec. 79.58(d), the average of the manufacturer's
total annual sales revenue for the previous three years shall be given.
(iii) If the manufacturer claims applicability of the special
provisions for aerosol products, pursuant to Sec. 79.58(e),
[[Page 58]]
then the purpose and recommended frequency of use shall be given.
(c) Tier 1 and Tier 2 Reports. 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 Sec. 79.51(c)(1)(ii)(B), Sec.
79.51(c)(1)(vi)(B)(2), or Sec. 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.
(1) Cover page. (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,
(iv) Group information, if applicable, including:
(A) Group name or grouping criteria,
(B) Name and address of responsible organization or entity reporting
for the group,
(C) Product trade name and manufacturer of each member fuel and
additive to which the report pertains.
(2) Executive Summary. 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 Information. 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 Sec. 79.55 for the applicable
fuel family.
(ii) Test additive composition and concentration
(4) Summary of Tier 1. (i) Literature Search. Pursuant to Sec.
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 Sec. 79.52(b) and/or health effects
testing requirements under Sec. 79.53, including justifications and
specific references.
(ii) Emission Characterization. Pursuant to Sec. 79.52(b), the
emission characterization shall include:
(A) Name, address, and telephone number of the laboratory performing
the characterization,
(B) Name and description of analytic methods used for
characterization.
(5) Summary of Tier 2. For each health effects test performed
pursuant to the provisions of Sec. 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
[[Page 59]]
Sec. 79.60), findings, and conclusions, including references if used to
support such results and conclusions,
(iii) Description of any problems and their resolution.
(6) Conclusions. 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) Appendices. 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
(D) Full reports for unpublished/in-house studies.
(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
(C) Lists of speciated emission products and their emission rates
reported in units of grams/mile.
(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 Sec. 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 Sec. 79.60 and the requirements in
Sec. 79.53(c)(1).
(d) Tier 3 Report. Subject to applicability as specified in Sec.
79.54, each manufacturer of a designated fuel or fuel additive, or each
group of such manufacturers pursuant to the provisions of Sec. 79.56,
shall submit the following information with respect to each Tier 3 test
conducted for such fuels or fuel additives:
(1) The test objectives, including a summary of the reason(s) why
such additional testing, beyond Tiers 1 and 2, was required;
(2) Name, address, and telephone number of each testing facility;
(3) Summary of test procedures, results and conclusions;
(4) Complete documentation of test protocols and emission generation
procedures, complete laboratory reports in compliance with the reporting
standards of Sec. 79.60, detailed test results and conclusions,
including references if used to support such results and conclusions,
and descriptions of any problems encountered and their resolution; and
(5) Laboratory certification information, personnel credentials, and
statements of compliance with the Good Laboratory Practices Standards
specified in Sec. 79.60.
(e) Availability of Information. (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 Sec. Sec. 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
[[Page 60]]
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.
(2) To assert a business confidentiality claim concerning any
information submitted under this subpart, the submitter must:
(i) Clearly mark the information as confidential at each location it
appears in the submission; and
(ii) Submit with the information claimed as confidential a separate
document setting forth the claim and listing each location at which the
information appears in the submission.
(3) If any person subsequently requests access to information
submitted under this subpart (other than health and safety test data and
other information concerning health and welfare effects), and such
information is subject to a claim of business confidentiality, the
request and any subsequent disclosure shall be governed by the
provisions of 40 CFR part 2.
[59 FR 33093, June 27, 1994, as amended at 62 FR 12572, 12576, Mar. 17,
1997; 85 FR 7069, Feb. 6, 2020]
Sec. 79.60 Good laboratory practices (GLP) standards for inhalation
exposure health effects testing.
(a) General Provisions--(1) Scope. (i) This section prescribes good
laboratory practices (GLPs) for conducting inhalation exposure studies
relating to motor vehicle emissions health effects testing under this
part. These directions are intended to ensure the quality and integrity
of health effects data submitted pursuant to registration regulations
issued under sections 211(b) or 211(e) of the Clean Air Act (CAA) (42
U.S.C. 7545).
(ii) This section applies to any study described by paragraph
(a)(1)(i) of this section which any person conducts, initiates, or
supports on or after May 27, 1994.
(iii) It is EPA's policy that all health effects data developed
under sections 211(b) and (e) of CAA be in accordance with provisions of
this section. If data are not developed in accordance with the
provisions of this section, EPA may consider such data insufficient to
evaluate the health effects of a motor vehicle's fuel or fuel additive
emissions, unless the submitter provides additional information
demonstrating that the data are reliable and adequate and EPA determines
that the data are sufficient.
(2) Definitions. As used in this section, the following terms shall
have the meanings specified:
Batch means a specific quantity or lot of a test fuel, additive/base
fuel mixture, or reference substance that has been characterized
according to Sec. 79.60(f)(1)(i).
CAA means the Clean Air Act.
Carrier means any material which is combined with engine/motor
vehicle emissions or a reference substance for administration to a test
system. ``Carrier'' includes, but is not limited to, clean, filtered
air, water, feed, and nutrient media.
Control atmosphere means clean, filtered air which is administered
to the test system in the course of a study for the purpose of
establishing a basis for comparison with the test atmosphere for
chemical or biological measurements.
Experimental start date means the first date the test atmosphere is
applied to the test system.
Experimental termination date means the last date on which data are
collected directly from the study.
Person includes an individual, partnership, corporation,
association, scientific or academic establishment, government agency, or
organizational unit thereof, and any other legal entity.
Quality assurance unit means any person or organizational element,
except the study director, designated by testing facility management to
perform the duties relating to quality assurance of the studies.
Raw data means any laboratory worksheets, records, memoranda, notes,
or exact copies thereof, that are the result of original observations
and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original
source as
[[Page 61]]
raw data. ``Raw data'' may include photographs, videotape, microfilm or
microfiche copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated instruments.
Reference substance means any chemical substance or mixture,
analytical standard, or material other than engine/motor vehicle
emissions and/or its carrier, that is administered to or used in
analyzing the test system in the course of a study. A ``reference
substance'' is used to establish a basis for comparison with the test
atmosphere for known chemical or biological measurements, i.e., positive
or negative control substance.
Specimen means any material derived from a test system for
examination or analysis.
Sponsor means person who initiates and supports, by provision of
financial or other resources, a study or a person who submits a study to
EPA in response to the CAA Section 211(b) or 211(e) Fuels and Fuel
Additives Registration Rule or a testing facility, if it both initiates
and actually conducts the study.
Study means any experiment, at one or more test sites, in which a
test system is exposed to a test atmosphere under laboratory conditions
to determine or help predict the health effects of that exposure in
humans, other living organisms, or media.
Study completion date means the date the final report is signed by
the study director.
Study director means the individual responsible for the overall
conduct of a study.
Study initiation date means the date the protocol is signed by the
study director.
Test substance means a vapor and/or aerosol mixture composed of
engine/motor vehicle emissions and clean, filtered air which is
administered directly, or indirectly, by the inhalation route to a test
system in a study which develops data to meet the registration
requirements of CAA section 211(b) or (e).
Test system means any animal, microorganism, chemical or physical
matrix, to which the test, control, or reference substance is
administered or added for study. This definition also includes
appropriate groups or components of the system not treated with the
test, control, or reference substance.
Testing facility means a person who actually conducts a study, i.e.,
actually uses the test substance in a test system. ``Testing facility''
encompasses only those operational units that are being or have been
used to conduct studies.
TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et
seq.).
(3) Applicability to studies performed under grants and contracts.
When a sponsor or other person utilizes the services of a consulting
laboratory, contractor, or grantee to perform all or a part of a study
to which this section applies, it shall notify the consulting
laboratory, contractor, or grantee that the service is, or is part of, a
study that must be conducted in compliance with the provisions of this
section.
(4) Statement of compliance or non-compliance. Any person who
submits to EPA a test in compliance with registration regulations issued
under CAA section 211(b) or section 211(e) shall include in the
submission a true and correct statement, signed by the sponsor and the
study director, of one of the following types:
(i) A statement that the study was conducted in accordance with this
section; or
(ii) A statement describing in detail all differences between the
practices used in the study and those required by this section; or
(iii) A statement that the person was not a sponsor of the study,
did not conduct the study, and does not know whether the study was
conducted in accordance with this section.
(5) Inspection of a testing facility. (i) A testing facility shall
permit an authorized employee or duly designated representative of EPA,
at reasonable times and in a reasonable manner, to inspect the facility
and to inspect (and in the case of records also to copy) all records and
specimens required to be maintained regarding studies to which this
section applies. The records inspection and copying requirements shall
not apply to quality assurance unit records of findings and problems, or
to actions recommended and taken,
[[Page 62]]
except the EPA may seek production of these records in litigation or
formal adjudicatory hearings.
(ii) EPA will not consider reliable for purposes of showing that a
test substance does or does not present a risk of injury to health or
the environment any data developed by a testing facility or sponsor that
refuses to permit inspection in accordance with this section. The
determination that a study will not be considered reliable does not,
however, relieve the sponsor of a required test of any obligation under
any applicable statute or regulation to submit the results of the study
to EPA.
(6) Effects of non-compliance. (i) Pursuant to sections 114, 208,
and 211(d) of the CAA, it shall be a violation of this section and a
violation of this rule (40 CFR part 79, subpart F) if:
(A) The test is not being or was not conducted in accordance with
any requirement of this part; or
(B) Data or information submitted to EPA under part 79, including
the statement required by Sec. 79.60(a)(4), include information or data
that are false or misleading, contain significant omissions, or
otherwise do not fulfill the requirements of this part; or
(C) Entry in accordance with Sec. 79.60(a)(5) for the purpose of
auditing test data is denied.
(ii) EPA, at its discretion, may not consider reliable for purposes
of showing that a chemical substance or mixture does not present a risk
of injury to health any study which was not conducted in accordance with
this part. EPA, at its discretion, may rely upon such studies for
purposes of showing adverse effects. The determination that a study will
not be considered reliable does not, however, relieve the sponsor of a
required test of the obligation under any applicable statute or
regulation to submit the results of the study to EPA.
(iii) If data submitted in compliance with registration regulations
issued under CAA section 211(b) or section 211(e) are not developed in
accordance with this section, EPA may determine that the sponsor has not
fulfilled its obligations under 40 CFR part 79 and may require the
sponsor to develop data in accordance with the requirements of this
section in order to satisfy such obligations.
(b) Organization and Personnel--(1) Personnel. (i) Each individual
engaged in the conduct of or responsible for the supervision of a study
shall have education, training, and experience, or combination thereof,
to enable that individual to perform the assigned functions.
(ii) Each testing facility shall maintain a current summary of
training and experience and job description for each individual engaged
in or supervising the conduct of a study.
(iii) There shall be a sufficient number of personnel for the timely
and proper conduct of the study according to the protocol.
(iv) Personnel shall take necessary personal sanitation and health
precautions designed to avoid contamination of test fuel and additive/
base fuel mixtures, test and reference substances, and test systems.
(v) Personnel engaged in a study shall wear clothing appropriate for
the duties they perform. Such clothing shall be changed as often as
necessary to prevent microbiological, radiological, or chemical
contamination of test systems and test, control, and reference
substances.
(vi) Any individual found at any time to have an illness that may
adversely affect the quality and integrity of the study shall be
excluded from direct contact with test systems, fuel and fuel/additive
mixtures, test and reference substances and any other operation or
function that may adversely affect the study until the condition is
corrected. All personnel shall be instructed to report to their
immediate supervisors any health or medical conditions that may
reasonably be considered to have an adverse effect on a study.
(2) Testing facility management. For each study, testing facility
management shall:
(i) Designate a study director as described in Sec. 79.60(b)(3)
before the study is initiated.
(ii) Replace the study director promptly if it becomes necessary to
do so during the conduct of a study.
[[Page 63]]
(iii) Assure that there is a quality assurance unit as described in
Sec. 79.60(b)(4).
(iv) Assure that test fuels and fuel/additive mixtures and test and
reference substances have been identified as to content, strength,
purity, stability, and uniformity, as applicable.
(v) Assure that personnel, resources, facilities, equipment,
materials and methodologies are available as scheduled.
(vi) Assure that personnel clearly understand the functions they are
to perform.
(vii) Assure that any deviations from these regulations reported by
the quality assurance unit are communicated to the study director and
corrective actions are taken and documented.
(3) Study director. For each study, a scientist or other
professional person with a doctorate degree or equivalent in toxicology
or other appropriate discipline shall be identified as the study
director. The study director has overall responsibility for the
technical conduct of the study, as well as for the interpretation,
analysis, documentation, and reporting of results, and represents the
single point of study control. The study director shall assure that:
(i) The protocol, including any changes, is approved as provided by
Sec. 79.60(g)(1)(i) and is followed;
(ii) All experimental data, including observations of unanticipated
responses of the test system are accurately recorded and verified;
(iii) Unforeseen circumstances that may affect the quality and
integrity of the study are noted when they occur, and corrective action
is taken and documented;
(iv) Test systems are as specified in the protocol;
(v) All applicable good laboratory practice regulations are
followed; and
(vi) All raw data, documentation, protocols, specimens, and final
reports are archived properly during or at the close of the study.
(4) Quality assurance unit. A testing facility shall have a quality
assurance unit which shall be responsible for monitoring each study to
assure management that the facilities, equipment, personnel, methods,
practices, records, and controls are in conformance with the regulations
in this section. For any given study, the quality assurance unit shall
be entirely separate from and independent of the personnel engaged in
the direction and conduct of that study. The quality assurance unit
shall conduct inspections and maintain records appropriate to the study.
(i) Quality assurance unit duties. (A) Maintain a copy of a master
schedule sheet of all studies conducted at the testing facility indexed
by test substance and containing the test system, nature of study, date
study was initiated, current status of each study, identity of the
sponsor, and name of the study director.
(B) Maintain copies of all protocols pertaining to all studies for
which the unit is responsible.
(C) Inspect each study at intervals adequate to ensure the integrity
of the study and maintain written and properly signed records of each
periodic inspection showing the date of the inspection, the study
inspected, the phase or segment of the study inspected, the person
performing the inspection, findings and problems, action recommended and
taken to resolve existing problems, and any scheduled date for re-
inspection. Any problems which are likely to affect study integrity
found during the course of an inspection shall be brought to the
attention of the study director and management immediately.
(D) Periodically submit to management and the study director written
status reports on each study, noting any problems and the corrective
actions taken.
(E) Determine that no deviations from approved protocols or standard
operating procedures were made without proper authorization and
documentation.
(F) Review the final study report to assure that such report
accurately describes the methods and standard operating procedures, and
that the reported results accurately reflect the raw data of the study.
(G) Prepare and sign a statement to be included with the final study
report which shall specify the dates inspections were made and findings
reported to management and to the study director.
[[Page 64]]
(ii) The responsibilities and procedures applicable to the quality
assurance unit, the records maintained by the quality assurance unit,
and the method of indexing such records shall be in writing and shall be
maintained. These items including inspection dates, the study inspected,
the phase or segment of the study inspected, and the name of the
individual performing the inspection shall be made available for
inspection to authorized employees or duly designated representatives of
EPA.
(iii) An authorized employee or a duly designated representative of
EPA shall have access to the written procedures established for the
inspection and may request test facility management to certify that
inspections are being implemented, performed, documented, and followed
up in accordance with this paragraph.
(c) Facilities--(1) General. Each testing facility shall be of
suitable size and construction to facilitate the proper conduct of
studies. Testing facilities which are not completely located within an
indoor controlled environment shall be of suitable location/proximity to
facilitate the proper conduct of studies. Testing facilities shall be
designed so that there is a degree of separation that will prevent any
function or activity from having an adverse effect on the study.
(2) Test system care facilities. (i) A testing facility shall have a
sufficient number of animal rooms or other test system areas, as needed,
to ensure proper separation of species or test systems, quarantine or
isolation of animals or other test systems, and routine or specialized
housing of animals or other test systems.
(ii) A testing facility shall have a number of animal rooms or other
test system areas separate from those described in paragraph (a) of this
section to ensure isolation of studies being done with test systems or
test, control, and reference substances known to be biohazardous,
including volatile atmospheres and aerosols, radioactive materials, and
infectious agents. The animal handling facility must operate under the
supervision of a veterinarian.
(iii) Separate areas shall be provided, as appropriate, for the
diagnosis, treatment, and control of laboratory test system diseases.
These areas shall provide effective isolation for the housing of test
systems either known or suspected of being diseased, or of being
carriers of disease, from other test systems.
(iv) Facilities shall have proper provisions for collection and
disposal of contaminated air, water, or other spent materials. When
animals are housed, facilities shall exist for the collection and
disposal of all animal waste and refuse or for safe sanitary storage of
waste before removal from the testing facility. Disposal facilities
shall be so provided and operated as to minimize vermin infestation,
odors, disease hazards, and environmental contamination.
(v) Facilities shall have provisions to regulate environmental
conditions (e.g., temperature, humidity, day length, etc.) as specified
in the protocol.
(3) Test system supply/operation areas. (i) There shall be storage
areas, as needed, for feed, bedding, supplies, and equipment. Storage
areas for feed and bedding shall be separated from areas where the test
systems are located and shall be protected against infestation or
contamination. Perishable supplies shall be preserved by appropriate
means.
(ii) Separate laboratory space and other space shall be provided, as
needed, for the performance of the routine and specialized procedures
required by studies.
(4) Facilities for handling test fuels and fuel/additive mixtures
and reference substances. (i) As necessary to prevent contamination or
mixups, there shall be separate areas for:
(A) Receipt and storage of the test fuels and fuel/additive mixtures
and reference substances;
(B) Mixing of the test fuels, fuel/additive mixtures, and reference
substances with a carrier, i.e., liquid hydrocarbon; and
(C) Storage of the test fuels, fuel/additive mixtures, and reference
substance/carrier mixtures.
(ii) Storage areas for test fuels and fuel/additive mixtures and
reference substances and for reference mixtures shall be separate from
areas housing
[[Page 65]]
the test systems and shall be adequate to preserve the identity,
strength, purity, and stability of the substances and mixtures.
(5) Specimen and data storage facilities. Space shall be secured for
archives for the storage and retrieval of all raw data and specimens
from completed studies.
(d) Equipment--(1) Equipment design. Equipment used in the
generation, measurement, or assessment of data and equipment used for
facility environmental control shall be of appropriate design and
adequate capacity to function according to the protocol and shall be
suitably located for operation, inspection, cleaning, and maintenance.
(2) Maintenance and calibration of equipment. (i) Equipment shall be
adequately inspected, cleaned, and maintained. Equipment used for the
generation, measurement, or assessment of data shall be adequately
tested, calibrated, and/or standardized.
(ii) The written standard operating procedures required under Sec.
79.60(e)(1)(ii)(K) shall set forth in sufficient detail the methods,
materials, and schedules to be used in the routine inspection, cleaning,
maintenance, testing, calibration, and/or standardization of equipment,
and shall specify, when appropriate, remedial action to be taken in the
event of failure or malfunction of equipment. The written standard
operating procedures shall designate the person responsible for the
performance of each operation.
(iii) Written records shall be maintained of all inspection,
maintenance, testing, calibrating, and/or standardizing operations.
These records, containing the date of the operation, shall describe
whether the maintenance operations were routine and followed the written
standard operating procedures. Written records shall be kept of non-
routine repairs performed on equipment as a result of failure and
malfunction. Such records shall document the nature of the defect, how
and when the defect was discovered, and any remedial action taken in
response to the defect.
(e) Testing Facilities Operation--(1) Standard operating procedures.
(i) A testing facility shall have standard operating procedures in
writing, setting forth study methods that management is satisfied are
adequate to insure the quality and integrity of the data generated in
the course of a study. All deviations in a study from standard operating
procedures shall be authorized by the study director and shall be
documented in the raw data. Significant changes in established standard
operating procedures shall be properly authorized in writing by
management.
(ii) Standard operating procedures shall be established for, but not
limited to, the following:
(A) Test system room preparation;
(B) Test system care;
(C) Receipt, identification, storage, handling, mixing, and method
of sampling of test fuels and fuel/additive mixtures and reference
substances;
(D) Test system observations;
(E) Laboratory or other tests;
(F) Handling of test animals found moribund or dead during study;
(G) Necropsy or postmortem examination of test animals;
(H) Collection and identification of specimens;
(I) Histopathology
(J) Data handling, storage and retrieval.
(K) Maintenance and calibration of equipment.
(L) Transfer, proper placement, and identification of test systems.
(iii) Each laboratory or other study area shall have immediately
available manuals and standard operating procedures relative to the
laboratory procedures being performed. Published literature may be used
as a supplement to standard operating procedures.
(iv) A historical file of standard operating procedures, and all
revisions thereof, including the dates of such revisions, shall be
maintained.
(2) Reagents and solutions. All reagents and solutions in the
laboratory areas shall be labeled to indicate identity, titer or
concentration, storage requirements, and expiration date. Deteriorated
or outdated reagents and solutions shall not be used.
(3) Animal and other test system care. (i) There shall be standard
operating procedures for the housing, feeding, handling, and care of
animals and other test systems.
[[Page 66]]
(ii) All newly received test systems from outside sources shall be
isolated and their health status or appropriateness for the study shall
be evaluated. This evaluation shall be in accordance with acceptable
veterinary medical practice or scientific methods.
(iii) At the initiation of a study, test systems shall be free of
any disease or condition that might interfere with the purpose or
conduct of the study. If during the course of the study, the test
systems contract such a disease or condition, the diseased test systems
shall be isolated, if necessary. These test systems may be treated for
disease or signs of disease provided that such treatment does not
interfere with the study. The diagnosis, authorization of treatment,
description of treatment, and each date of treatment shall be documented
and shall be retained.
(iv) When laboratory procedures require test animals to be
manipulated and observed over an extended period of time or when studies
require test animals to be removed from and returned to their housing
units for any reason (e.g., cage cleaning, treatment, etc.), these test
systems shall receive appropriate identification (e.g., tattoo, color
code, etc.). Test system identification shall conform with current
laboratory animal handling practice. All information needed to
specifically identify each test system within the test system-housing
unit shall appear on the outside of that unit. Suckling animals are
excluded from the requirement of individual identification unless
otherwise specified in the protocol.
(v) Except as specified in paragraph (e)(3)(v)(A) of this section,
test animals of different species shall be housed in separate rooms when
necessary. Test animals of the same species, but used in different
studies, shall not ordinarily be housed in the same room when
inadvertent exposure to the test or reference substances or test system
mixup could affect the outcome of either study. If such mixed housing is
necessary, adequate differentiation by space and identification shall be
made.
(A) Test systems that may be used in multispecies tests need not be
housed in separate rooms, provided that they are adequately segregated
to avoid mixup and cross-contamination.
(B) [Reserved]
(vi) Cages, racks, pens, enclosures, and other holding, rearing, and
breeding areas, and accessory equipment, shall be cleaned and sanitized
at appropriate intervals.
(vii) Feed and water used for the test animals shall be analyzed
periodically to ensure that contaminants known to be capable of
interfering with the study and reasonably expected to be present in such
feed or water are not present at greater than trace levels.
Documentation of such analyses shall be maintained as raw data.
(viii) Bedding used in animal cages or pens shall not interfere with
the purpose or conduct of the study and shall be changed as often as
necessary to keep the animals dry and clean.
(ix) If any pest control materials are used, the use shall be
documented. Cleaning and pest control materials that interfere with the
study shall not be used.
(x) All test systems shall be acclimatized to the environmental
conditions of the test, prior to their use in a study.
(f) Test fuels, additive/base fuel mixtures, and reference
substances--(1) Test fuel, fuel/additive mixture, and reference
substance identity. (i) The product brand name/service mark, strength,
purity, content, or other characteristics which appropriately define the
test fuel, fuel/additive mixture, or reference substance shall be
reported for each batch and shall be documented before its use in a
study. Methods of synthesis, fabrication, or derivation, as appropriate,
of the test fuel, fuel/additive mixture, or reference substance shall be
documented by the sponsor or the testing facility, and such location of
documentation shall be specified.
(ii) The stability of test fuel, fuel/additive mixture, and
reference substances under storage conditions at the test site shall be
known for all studies.
(2) Test fuel, additive/base fuel mixture, and reference substance
handling. Procedures shall be established for a system for the handling
of the test fuel, fuel/additive mixture, and reference substance(s) to
ensure that:
(i) There is proper storage.
(ii) Distribution is made in a manner designed to preclude the
possibility of
[[Page 67]]
contamination, deterioration, or damage.
(iii) Proper identification is maintained throughout the
distribution process.
(iv) The receipt and distribution of each batch is documented. Such
documentation shall include the date and quantity of each batch
distributed or returned.
(3) Mixtures of test emissions or reference solutions with carriers.
(i) For test emissions or each reference substance mixed with a
carrier, tests by appropriate analytical methods shall be conducted:
(A) To determine the uniformity of the test substance and to
determine, periodically, the concentration of the test emissions or
reference substance in the mixture;
(B) When relevant to the conduct of the experiment, to determine the
solubility of each reference substance in the carrier mixture before the
experimental start date; and
(C) To determine the stability of test emissions or a reference
solution in the test substance before the experimental start date or
concomitantly according to written standard operating procedures, which
provide for periodic analysis of each batch.
(ii) Where any of the components of the reference substance/carrier
mixture has an expiration date, that date shall be clearly shown on the
container. If more than one component has an expiration date, the
earliest date shall be shown.
(iii) If a chemical or physical agent is used to facilitate the
mixing of a test substance with a carrier, assurance shall be provided
that the agent does not interfere with the integrity of the test.
(g) Protocol for and conduct of a study--(1) Protocol. (i) Each
study shall have a written protocol that clearly indicates the
objectives and all methods for the conduct of the study. The protocol
shall contain but shall not be limited to the following information:
(A) A descriptive title and statement of the purpose of the study.
(B) Identification of the test fuel, fuel/additive mixture, and
reference substance by name, chemical abstracts service (CAS) number or
code number, as applicable.
(C) The name and address of the sponsor and the name and address of
the testing facility at which the study is being conducted.
(D) The proposed experimental start and termination dates.
(E) Justification for selection of the test system, as necessary.
(F) Where applicable, the number, body weight, sex, source of
supply, species, strain, substrain, and age of the test system.
(G) The procedure for identification of the test system.
(H) A description of the experimental design, including methods for
the control of bias.
(I) Where applicable, a description and/or identification of the
diet used in the study. The description shall include specifications for
acceptable levels of contaminants that are reasonably expected to be
present in the dietary materials and are known to be capable of
interfering with the purpose or conduct of the study if present at
levels greater than established by the specifications.
(J) Each concentration level, expressed in milligrams per cubic
meter of air or other appropriate units, of the test or reference
substance to be administered and the frequency of administration.
(K) The type and frequency of tests, analyses, and measurements to
be made.
(L) The records to be maintained.
(M) The date of approval of the protocol by the sponsor and the
dated signature of the study director.
(N) A statement of the proposed statistical method.
(ii) All changes in or revisions of an approved protocol and the
reasons therefor shall be documented, signed by the study director,
dated, and maintained with the protocol.
(2) Conduct of a study. (i) The study shall be conducted in
accordance with the protocol.
(ii) The test systems shall be monitored in conformity with the
protocol.
(iii) Specimens shall be identified by test system, study, nature,
and date of collection. This information shall be located on the
specimen container or
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shall accompany the specimen in a manner that precludes error in the
recording and storage of data.
(iv) In animal studies where histopathology is required, records of
gross findings for a specimen from postmortem observations shall be
available to a pathologist when examining that specimen
histopathologically.
(v) All data generated during the conduct of a study, except those
that are generated by automated data collection systems, shall be
recorded directly, promptly, and legibly in ink. All data entries shall
be dated on the day of entry and signed or initialed by the person
entering the data. Any change in entries shall be made so as not to
obscure the original entry, shall indicate the reason for such change,
and shall be dated and signed or identified at the time of the change.
In automated data collection systems, the individual responsible for
direct data input shall be identified at the time of data input. Any
change in automated data entries shall be made so as not to obscure the
original entry, shall indicate the reason for change, shall be dated,
and the responsible individual shall be identified.
(h) Records and Reports--(1) Reporting of study results. (i) A final
report shall be prepared for each study and shall include, but not
necessarily be limited to, the following:
(A) Name and address of the facility performing the study and the
dates on which the study was initiated and was completed, terminated, or
discontinued.
(B) Objectives and procedures stated in the approved protocol,
including any changes in the original protocol.
(C) Statistical methods employed for analyzing the data.
(D) The test fuel, additive/base fuel mixture, and test and
reference substances identified by name, chemical abstracts service
(CAS) number or code number, strength, purity, content, or other
appropriate characteristics.
(E) Stability, and when relevant to the conduct of the study, the
solubility of the test emissions and reference substances under the
conditions of administration.
(F) A description of the methods used.
(G) A description of the test system used. Where applicable, the
final report shall include the number of animals or other test organisms
used, sex, body weight range, source of supply, species, strain and
substrain, age, and procedure used for identification.
(H) A description of the concentration regimen as daily exposure
period, i.e., number of hours, and exposure duration, i.e., number of
days.
(I) A description of all circumstances that may have affected the
quality or integrity of the data.
(J) The name of the study director, the names of other scientists or
professionals and the names of all supervisory personnel, involved in
the study.
(K) A description of the transformations, calculations, or
operations performed on the data, a summary and analysis of the data,
and a statement of the conclusions drawn from the analysis.
(L) The signed and dated reports of each of the individual
scientists or other professionals involved in the study, including each
person who, at the request or direction of the testing facility or
sponsor, conducted an analysis or evaluation of data or specimens from
the study after data generation was completed.
(M) The locations where all specimens, raw data, and the final
report are to be kept or stored.
(N) The statement, prepared and signed by the quality assurance
unit, as described in Sec. 79.60(b)(4)(i)(G).
(ii) The final report shall be signed and dated by the study
director.
(iii) Corrections or additions to a final report shall be in the
form of an amendment by the study director. The amendment shall clearly
identify that part of the final report that is being added to or
corrected and the reasons for the correction or addition, and shall be
signed and dated by the person responsible. Modification of a final
report to comply with the submission requirements of EPA does not
constitute a correction, addition, or amendment to a final report.
[[Page 69]]
(iv) A copy of the final report and of any amendment to it shall be
maintained by the sponsor and the test facility.
(2) Storage and retrieval of records and data. (i) All raw data,
documentation, records, protocols, specimens, and final reports
generated as a result of a study shall be retained. Specimens obtained
from mutagenicity tests, wet specimens of blood, urine, feces, and
biological fluids, do not need to be retained after quality assurance
verification. Correspondence and other documents relating to
interpretation and evaluation of data, other than those documents
contained in the final report, also shall be retained.
(ii) All raw data, documentation, protocols, specimens, and interim
and final reports shall be archived for orderly storage and expedient
retrieval. Conditions of storage shall minimize deterioration of the
documents or specimens in accordance with the requirements for the time
period of their retention and the nature of the documents of specimens.
A testing facility may contract with commercial archives to provide a
repository for all material to be retained. Raw data and specimens may
be retained elsewhere provided that the archives have specific reference
to those other locations.
(iii) An individual shall be identified as responsible for the
archiving of records.
(iv) Access to archived material shall require authorization and
documentation.
(v) Archived material shall be indexed to permit expedient
retrieval.
(3) Retention of records. (i) Record retention requirements set
forth in this section do not supersede the record retention requirements
of any other regulations in this subchapter.
(ii) Except as provided in paragraph (h)(3)(iii) of this section,
documentation records, raw data, and specimens pertaining to a study and
required to be retained by this part shall be archived for a period of
at least ten years following the completion of the study.
(iii) Wet specimens, samples of test fuel, additive/base fuel
mixtures, or reference substances, and specially prepared material which
are relatively fragile and differ markedly in stability and quality
during storage, shall be retained only as long as the quality of the
preparation affords evaluation. Specimens obtained from mutagenicity
tests, wet specimens of blood, urine, feces, biological fluids, do not
need to be retained after quality assurance verification. In no case
shall retention be required for a longer period than that set forth in
paragraph (h)(3)(ii) of this section.
(iv) The master schedule sheet, copies of protocols, and records of
quality assurance inspections, as required by Sec. 79.60(b)(4)(iii)
shall be maintained by the quality assurance unit as an easily
accessible system of records for the period of time specified in
paragraph (h)(3)(ii) of this section.
(v) Summaries of training and experience and job descriptions
required to be maintained by Sec. 79.60(b)(1)(ii) may be retained along
with all other testing facility employment records for the length of
time specified in paragraph (h)(3)(ii) of this section.
(vi) Records and reports of the maintenance and calibration and
inspection of equipment, as required by Sec. 79.60(d)(2) (ii) and
(iii), shall be retained for the length of time specified in paragraph
(h)(3)(ii) of this section.
(vii) If a facility conducting testing or an archive contracting
facility goes out of business, all raw data, documentation, and other
material specified in this section shall be transferred to the sponsor
of the study for archival.
(viii) Records required by this section may be retained either as
original records or as true copies such as photocopies, microfilm,
microfiche, or other accurate reproductions of the original records.
Sec. 79.61 Vehicle emissions inhalation exposure guideline.
(a) Purpose. This guideline provides additional information on
methodologies required to conduct health effects tests involving
inhalation exposures to vehicle combustion emissions from fuels or fuel/
additive mixtures. Where this guideline and the other health effects
testing guidelines in 40 CFR 79.62 through 79.68 specify differing
values
[[Page 70]]
for the same test parameter, the specifications in the individual health
test guideline shall prevail for that health effect endpoint.
(b) Definitions. For the purposes of this section the following
definitions apply.
Acute inhalation study means a short-term toxicity test
characterized by a single exposure by inhalation over a short period of
time (at least 4 hours and less than 24 hours), followed by at least 14
days of observation.
Aerodynamic diameter means the diameter of a sphere of unit density
that has the same settling velocity as the particle of the test
substance. It is used to compare particles of different sizes, densities
and shapes, and to predict where in the respiratory tract such particles
may be deposited. It applies to the size of aerosol particles.
Chronic inhalation study means a prolonged and repeated exposure by
inhalation for the life span of the test animal; technically, two years
in the rat.
Concentration means an exposure level. Exposure is expressed as
weight or volume of test aerosol/substance per volume of air, usually
mg/m\3\ or as parts per million (ppm) over a given time period.
Micrograms per cubic meter ([micro]g/m\3\) or parts per billion may be
appropriate, as well.
Cumulative toxicity means the adverse effects of repeated exposures
occurring as a result of prolonged action or increased concentration of
the administered test substance or its metabolites in the susceptible
tissues.
Inhalable diameter means that aerodynamic diameter of a particle
which is considered to be inhalable for the organism. It is used to
refer to particles which are capable of being inhaled and may be
deposited anywhere within the respiratory tract from the trachea to the
alveoli.
Mass median aerodynamic diameter (MMAD) means the calculated
aerodynamic diameter, which divides the particles of an aerosol in half
based on the mass of the particles. Fifty percent of the particles in
mass will be larger than the median diameter, and fifty percent will be
smaller than the median diameter. MMAD describes the particle
distribution of any aerosol based on the weight and size of the
particles. MMAD and the geometric standard deviation describe the
particle-size distribution.
Material safety data sheet (MSDS) means documentation or information
on the physical, chemical, and hazardous characteristics of a given
chemical, usually provided by the product's manufacturer.
Reynolds number means a dimensionless number that is proportional to
the ratio of inertial forces to frictional forces acting on a fluid. It
quantitatively provides a measure of whether flow is laminar or
turbulent. A fluid traveling through a pipe is fully developed into a
laminar flow for a Reynolds number less than 2000, and fully developed
into a turbulent flow for a Reynolds number greater than 4000.
Subacute inhalation toxicity means the adverse effects occurring as
a result of the repeated daily exposure of experimental animals to a
chemical by inhalation for part (less than 10 percent) of a lifespan;
generally, less than 90 days.
Subchronic inhalation study means a repeated exposure by inhalation
for part (approximately 10 percent) of a life span of the exposed test
animal.
Toxic effect means an adverse change in the structure or function of
an experimental animal as a result of exposure to a chemical substance.
(c) Principles and design criteria of inhalation exposure systems.
Proper conduct of inhalation toxicity studies of the emissions of fuels
and additive/fuel mixtures requires that the exposure system be designed
to ensure the controlled generation of the exposure atmosphere, the
adequate dilution of the test emissions, delivery of the diluted
exposure atmosphere to the test animals, and use of appropriate exposure
chamber systems selected to meet criteria for a given exposure study.
(1) Emissions generation. Emissions shall be generated according to
the specifications in 40 CFR 79.57.
(2) Dilution and delivery systems. (i) The delivery system is the
means used to transport the emissions from the generation system to the
exposure system. The dilution system is generally a component of the
delivery system.
(ii) Dilution provides control of the emissions concentration
delivered to
[[Page 71]]
the exposure system, serving the function of diluting the associated
combustion gases, such as carbon monoxide, carbon dioxide, nitrogen
oxides, sulfur dioxide and other noxious gases and vapors, to levels
that will ensure that there are no significant or measurable responses
in the test animals as a result of exposure to the combustion gases. The
formation of particle species is strongly dependent on the dilution
rate, as well.
(iii) The engine exhaust system shall connect to the first-stage-
dilution section at 90[deg] to the axis of the dilution section. This is
then connected to a right angle elbow on the center line of the dilution
section. Engine emissions are injected through the elbow so that exhaust
flow is concurrent to dilution flow.
(iv) Materials. In designing the dilution and delivery systems, the
use of plastic, e.g., PVC and similar materials, copper, brass, and
aluminum pipe and tubing shall be avoided if there exists a possibility
of chemical reaction occurring between emissions and tubing. Stainless
steel pipe and tubing is recommended as the best choice for most
emission dilution and delivery applications, although glass and teflon
may be appropriate, as well.
(v) Flow requirements. (A) Conduit for dilute raw emissions shall be
of such dimensions as to provide residence times for the emissions on
the order of less than one second to several seconds before the
emissions are further diluted and introduced to the test chambers. With
the high flow rates in the dilute raw emissions conduit, it will be
necessary to sample various portions of the dilute emissions for
delivering differing concentrations to the test chambers. The unused
portions of the emissions stream are normally exhausted to the
atmosphere outside of the exposure facility.
(B) Dimensions of the dilute raw exhaust conduit shall be such that,
at a minimum, the flow Reynolds number is 70,000 or greater (see Mokler,
et al., 1984 in paragraph (f)(13) of this section). This will maintain
highly turbulent flow conditions so that there is more complete mixing
of the exhaust emissions.
(C) Wall losses. The delivery system shall be designed to minimize
wall losses. This can be done by sizing the tubing or pipe to maintain
laminar flow of the diluted emissions to the exposure chamber. A flow
Reynolds number of 1000-3000 will ensure minimal wall losses. Also, the
length of and number and degree of bends in the delivery lines to the
exposure chamber system shall be minimized.
(D) Whole-body exposure vs. nose-only exposure delivery systems.
Flow rates through whole-body chamber systems are of the order of 100
liters per minute to 500 liters per minute. Nose-only systems are on the
order of less than 50 liters per minute. To maintain laminar flow
conditions, the principles described in paragraph (c)(2)(v)(C) of this
section apply to both systems.
(vi) Dilution requirements. (A) To maintain the water vapor, and
dissolved organic compounds, in the raw exhaust emissions stream, a
manufacturer/tester will initially dilute one part emissions with a
minimum of five parts clean, filtered air (see Hinners, et al., 1979 in
paragraph (f)(11) of this section). Depending on the water vapor content
of a particular fuel/additive mixture's combustion emissions and the
humidity of the dilution air, initial exhaust dilutions as high as 1:15
or 1:20 may be necessary to maintain the general character of the
exhaust as it cools, e.g., M100. At this point, it is expected that the
exhaust stream would be further diluted to more appropriate levels for
rodent health effects testing.
(B) A maximum concentration (minimum dilution) of the raw exhaust
going into the test animal cages is anticipated to lie in the range
between 1:5 and 1:50 exhaust emissions to clean, filtered air. The
minimum concentration (maximum dilution) of raw exhaust for health
effects testing is anticipated to be in range between 1:100 and 1:150.
Individual manufacturers will treat these ranges as approximations only
and will determine the optimum range of emission concentrations to
elicit effects in Tier 2 health testing for their particular fuel/fuel
additive mixture.
(3) Exposure chamber systems--(i) Referenced Guidelines. (A) The
U.S. Department of Health and Human Services
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``Guide for the Care and Use of Laboratory Animals'' (Guide), 1985 cited
in paragraph (c)(3)(ii)(A)(4), and in paragraphs (d)(2)(i), (d)(2)(ii),
(d)(2)(iii), (d)(4)(ii), and (d)(4)(iii) of this section, has been
incorporated by reference.
(B) This incorporation by reference was approved by the Director of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Copies may be purchased from the Superintendent of Documents, U.S.
Government Printing Office, Washington, DC 20402. Copies may be
inspected at U.S. EPA, OAR, 401 M Street SW, Washington, DC 20460 or at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(ii) Exposure chambers. There are two basic types of dynamic
inhalation exposure chambers, whole-body chambers and nose-/head-only
exposure chambers (see Cheng and Moss, 1989 in paragraph (f)(8) of this
section).
(A) Whole-body chambers. (1) The flow rate through a chamber shall
be maintained at 15 air changes per hour.
(2) The chambers are usually maintained at a slightly negative
pressure (0.5 to 1.5 inch of water) to prevent leakage of test substance
into the exposure room.
(3) The exposure chamber shall be designed in such a way as to
provide uniform distribution of exposure concentrations in all
compartments (see Cheng et al., 1989 in paragraph (f)(7) of this
section).
(4) Animals are housed in separate compartments inside the chamber,
where the whole surface area of an animal is exposed to the test
material. The spaces required for different animal species shall follow
the Guide. In general, the volume of animal bodies occupy less than 5
percent of the chamber volume.
(B) Head/nose-only exposure chambers. (1) In head/nose-only exposure
chambers, only the head (oronasal) portion of the animal is exposed to
the test material.
(2) The chamber volume and flow rates are much less than in the
whole-body exposure chambers because the subjects are usually restrained
in a tube holder where the animal's breathing can be easily monitored.
The head/nose-only exposure chamber is suitable for short-term exposures
or when use of a small amount of test material is required.
(iii) Since whole-body exposure appears to be the least stressful
mode of exposure, it is the preferred method. In general, head/nose only
exposure, which is sometimes used to avoid concurrent exposure by the
dermal or oral routes, i.e., grooming, is not recommended because of the
stress accompanying the restraining of the animals. However, there may
be specific instances where it may be more appropriate than whole-body
exposure. The tester shall provide justification for its selection.
(d) Inhalation exposure procedures--(1) Animal selection. (i) The
rat is the preferred species for vehicle emission inhalation health
effects testing. Commonly used laboratory strains shall be used. Any
rodent species may be used, but the tester shall provide justification
for the choice of that species.
(ii) Young adult animals, approximately ten weeks of age for the
rat, shall be used. At the commencement of the study, the weight
variation of animals used shall not exceed 20
percent of the mean weight for each sex. Animals shall be randomly
assigned to treatment and control groups according to their weight.
(iii) An equal number of male and female rodents shall be used at
each concentration level. Situations may arise where use of a single sex
may be appropriate. Females, in general, shall be nulliparous and
nonpregnant.
(iv) The number of animals used at each concentration level and in
the control group(s) depends on the type of study, number of biological
end points used in the toxicity evaluation, the pre-determined
sensitivity of detection and power of significance of the study, and the
animal species. For an acute study, at least five animals of each sex
shall be used in each test group. For both the subacute and subchronic
studies, at least 10 rodents of each sex shall be used in each test
group. For a chronic study, at least 20 male and 20 female
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rodents shall be used in each test group.
(A) If interim sacrifices are planned, the number of animals shall
be increased by the number of animals scheduled to be sacrificed during
the course of the study.
(B) For a chronic study, the number of animals at the termination of
the study must be adequate for a meaningful and valid statistical
evaluation of chronic effects.
(v) A concurrent control group is required. This group shall be
exposed to clean, filtered air under conditions identical to those used
for the group exposed to the test atmosphere.
(vi) The same species/strain shall be used to make comparisons
between fuel-only and fuel/additive mixture studies. If another species/
strain is used, the tester shall provide justification for its
selection.
(2) Animal handling and care. (i) A key element in the conduct of
inhalation exposure studies is the proper handling and care of the test
animal population. Therefore, the exposure conditions must conform
strictly with the conditions for housing and animal care and use set
forth in the Guide.
(ii) In whole-body exposure chambers, animals shall be housed in
individual caging. The minimum cage size per animal will be in
accordance with instructions set forth in the Guide.
(iii) Chambers shall be cleaned and maintained in accordance with
recommendations and schedules set forth in the Guide.
(A) Observations shall be made daily with appropriate actions taken
to minimize loss of animals to the study (e.g., necropsy or
refrigeration of animals found dead and isolation or sacrifice of weak
or moribund animals). Exposure systems using head/nose-only exposure
chambers require no special daily chamber maintenance. Chambers shall be
inspected to ensure that they are clean, and that there are no
obstructions in the chamber which would restrict air flow to the
animals. Whole-body exposure chambers will be inspected on a minimum of
twice daily, once before exposures and once after exposures.
(B) Signs of toxicity shall be recorded as they are observed,
including the time of onset, degree, and duration.
(C) Cage-side observations shall include, but are not limited to:
changes in skin, fur, eye and mucous membranes, respiratory, autonomic,
and central nervous systems, somatomotor activity, and behavioral
patterns. Particular attention shall be directed to observation of
tremors, convulsions, salivation, diarrhea, lethargy, sleep, and coma.
(iv) Food and water will be withheld from animals for head/nose-only
exposure systems. For whole-body-exposure systems, water only may be
provided. When the exposure generation system is not operating, food
will be available ad libitum. During operation of the generation system,
food will be withheld to avoid possible contamination by emissions.
(v) At the end of the study period, all survivors in the main study
population shall be sacrificed. Moribund animals shall be removed and
sacrificed when observed.
(3) Concentration levels and selection. (i) In acute and subacute
toxicity tests, at least three exposure concentrations and a control
group shall be used and spaced appropriately to produce test groups with
a range of toxic effects and mortality rates. The data shall be
sufficient to produce a concentration-response curve and permit an
acceptable estimation of the median lethal concentration.
(ii) In subchronic and chronic toxicity tests, testers shall use at
least three different concentration levels, with a control exposure
group, to determine a concentration-response relationship.
Concentrations shall be spaced appropriately to produce test groups with
a range of toxic effects. The concentration-response data may also be
sufficient to determine a NOAEL, unless the result of a limit test
precludes such findings. The criteria for selecting concentration levels
has been published (40 CFR 798.2450 and 798.3260).
(A) The highest concentration shall result in toxic effects but not
produce an incidence of fatalities which would prevent a meaningful
evaluation of the study.
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(B) The lowest concentration shall not produce toxic effects which
are directly attributable to the test exposure. Where there is a useful
estimation of human exposure, the lowest concentration shall exceed
this.
(C) The intermediate concentration level(s) shall produce minimal
observable toxic effects. If more than one intermediate concentration
level is used, the concentrations shall be spaced to produce a gradation
of toxic effects.
(D) In the low, intermediate, and control exposure groups, the
incidence of fatalities shall be low to absent, so as not to preclude a
meaningful evaluation of the results.
(4) Exposure chamber environmental conditions. The following
environmental conditions in the exposure chamber are critical to the
maintenance of the test animals: flow; temperature; relative humidity;
lighting; and noise.
(i) Filtered and conditioned air shall be used during exposure, to
dilute the exhaust emissions, and during non- exposure periods to
maintain environmental conditions that are free of trace gases, dusts,
and microorganisms on the test animals. Twelve to fifteen air changes
per hour will be provided at all times to whole-body-exposure chambers.
The minimum air flow rate for head/nose-only exposure chambers will be a
function of the number of animals and the average minute volume of the
animals:
Qminimum(L/min) = 2 x number of animals x average minute
volume
(see Cheng and Moss, 1989 in paragraph (f)(8) of this section).
(ii) Recommended ranges of temperature for various species are given
in the Guide. The recommended temperature ranges will be used for
establishing temperature conditions of whole-body- exposure chambers.
For rodents in whole-body-exposure chambers, the recommended temperature
is 22 [deg]C 2 [deg]C and for rabbits, it is 20
[deg]C 3 [deg]C. Temperature ranges have not been
established for head/nose-only tubes; however, recommended maximum
temperature limits have been established at the Inhalation Toxicology
Research Institute (see Barr, 1988 in paragraph (f)(1) of this section).
Maximum temperature for rats and mice in head/nose-only tubes is 23
[deg]C.
(iii) Relative humidity. The relative humidity in the chamber air is
important for heat balance and shall be maintained between 40 percent
and 60 percent, but in certain instances, this may not be practicable.
Testers shall follow Guide recommends for a 30 percent to 70 percent
relative humidity range for rodents in exposure chambers.
(iv) Lighting. Light intensity of 30 foot candles at 3 ft. from the
floor of the exposure facility is recommended (see Rao, 1986 in
paragraph (f)(16) of this section).
(5) Exposure conditions. Unless precluded by the requirements of a
particular test protocol, animal subjects shall be exposed to the test
atmosphere based on a nominal 5-day-per-week regimen, subject to the
following rules:
(i) Each daily exposure must be at least 6 hours plus the time
necessary to build the chamber atmosphere to 90 percent of the target
exposure atmosphere. Interruptions of daily exposures caused by
technical difficulties, if infrequent in occurrence and limited in
duration, may be made up the same day by adding equivalent exposure time
after the technical problem has been corrected and the exposure
atmosphere restored to the required level.
(ii) Normally, no more than two non-exposure days may occur
consecutively during the test period. However, if a third consecutive
non-exposure day should occur due to circumstances beyond the tester's
control, it may be remedied by adding a supplementary exposure day.
Federal and other holidays do not constitute such circumstances.
Whenever possible, a make-up day should be taken at the first
opportunity, i.e., on the next day which would otherwise have been an
intentional non-exposure day. If a compensatory day must be scheduled at
the end of the standard test period, then it may occur either:
(A) Immediately following the last standard exposure day, with no
intervening non-exposure days; or
(B) With up to two intervening non-exposure days, provided that no
fewer than two consecutive compensatory exposure days are completed
before the
[[Page 75]]
test is terminated and the animals sacrificed.
(iii) Except as allowed in paragraph (d)(5)(ii)(B) of this section,
in no case shall there be fewer than four exposure days per week at any
time during the test period.
(iv) A nominal 90-day (13-week) subchronic test period shall include
no fewer than 63 total exposure days.
(6) Exposure atmosphere. (i) The exposure atmosphere shall be held
as constant as is practicable and must be monitored continuously or
intermittently, depending on the method of analysis, to ensure that
exposure levels are at the target values or within stated limits during
the exposure period. Sampling methodology will be determined based on
the type of generation system and the type of exposure chamber system
specified for the exposure study.
(A) Integrated samples of test atmosphere aerosol shall be taken
daily during the exposure period from a single representative sample
port in the chamber near the breathing zone of the animals. Gas samples
shall be taken daily to determine concentrations (ppm) of the major
vapor components of the test atmosphere including CO, CO2,
NOX, SO2, and total hydrocarbons.
(B) To ensure that animals in different locations of the chamber
receive a similar exposure atmosphere, distribution of an aerosol or
vapor concentration in exposure chambers can be determined without
animals during the developmental phase of the study, or it can be
determined with animals early in the study. For head/nose-only exposure
chambers, it may not be possible to monitor the chamber distribution
during the exposure, because the exposure port contains the animal.
(C) During the development of the emissions generation system,
particle size analysis shall be performed to establish the stability of
an aerosol concentration with respect to particle size. Over the course
of the exposure, analysis shall be conducted as often as is necessary to
determine the consistency of particle size distribution.
(D) Chamber rise and fall times. The rise time required for the
exposure concentration to reach 90 percent of the stable concentration
after the generator is turned on, and the fall time when the chamber
concentration decreases to 10 percent of the stable concentration after
the generation system is stopped shall be determined in the
developmental phase of the study. Time-integrated samples collected for
calculating exposure concentrations shall be taken after the rise time.
The daily exposure time is exclusive of the rise or the fall time.
(ii) Instrumentation used for a given study will be determined based
on the type of generation system and the type of exposure chamber system
specified for the exposure study.
(A) For exhaust studies, combustion gases shall be sampled by
collecting exposure air in bags and then analyzing the collected air
sample to determine major components of the combustion gas using gas
analyzers. Exposure chambers can also be connected to gas analyzers
directly by using sampling lines and switching valves. Samples can be
taken more frequently using the latter method. Aerosol instruments, such
as photometers, or time-integrated gravimetric determination may be used
to determine the stability of any aerosol concentration in the chamber.
(B) For evaporative emission studies, concentration of fuel vapors
can usually be determined by using a gas chromatograph (GC) and/or
infrared (IR) spectrometry. Grab samples for intermittent sampling can
be taken from the chamber by using bubble samplers with the appropriate
solvent to collect the vapors, or by collecting a small volume of air in
a syringe. Intermediate or continuous monitoring of the chamber
concentration is also possible by connecting the chamber with a GC or IR
detector.
(7) Monitoring chamber environmental conditions may be performed by
a computer system or by exposure system operating personnel.
(i) The flow-metering device used for the exposure chambers must be
a continuous monitoring device, and actual flow measurements must be
recorded at least every 30 minutes. Accuracy must be 5 percent of full scale range. Measurement of air flow
through the
[[Page 76]]
exposure chamber may be accomplished using any device that has
sufficient range to accurately measure the air flow for the given
chamber. Types of flow metering devices include rotameters, orifice
meters, venturi meters, critical orifices, and turbinemeters (see
Benedict, 1984 in paragraph (f)(4) and Spitzer, 1984 in paragraph
(f)(17) of this section).
(ii) Pressure. Pressure measurement may be accomplished using
manometers, electronic pressure transducers, magnehelics, or similar
devices (see Gillum, 1982 in paragraph (f)(10) of this section).
Accuracy of the pressure device must be 5 percent
of full scale range. Pressure measurements must be continuous and
recorded at least every 30 minutes.
(iii) Temperature. The temperature of exposure chambers must be
monitored continuously and recorded at least every 30 minutes.
Temperature may be measured using thermometers, RTD's, thermocouples,
thermistors, or other devices (see Benedict, 1984 in paragraph (f)(4) of
this section). It is necessary to incorporate an alarm system into the
temperature monitoring system. The exposure operators must be notified
by the alarm system when the chamber temperature exceeds 26.7 [deg]C (80
[deg]F). The exposure must be discontinued and emergency procedures
enacted to immediately reduce temperatures or remove test animals from
high temperature environment when chamber temperatures exceed 29 [deg]C.
Accuracy of the temperature monitoring device will be 1 [deg]C for the temperature range of 20-30 [deg]C.
(iv) Relative humidity. The relative humidity of exposure chambers
must be monitored continuously and recorded at least every 30 minutes.
Relative humidity may be measured using various devices (see Chaddock,
1985 in paragraph (f)(6) of this section).
(v) Lighting shall be measured quarterly, or once at the beginning,
middle, and end of the study for shorter studies.
(vi) Noise level in the exposure chamber(s) shall be measured
quarterly, or once at the beginning, middle, and end of the study for
shorter studies.
(vii) Oxygen content is critical, especially in nose-only chamber
systems, and shall be greater than or equal to 19 percent in the test
cages. An oxygen sensor shall be located at a single position in the
test chamber and a lower alarm limit of 18 percent shall be used to
activate an alarm system.
(8) Safety procedures and requirements. In the case of potentially
explosive test substance concentrations, care shall be taken to avoid
generating explosive atmospheres.
(i) It is mandatory that the upper explosive limit (UEL) and lower
explosive limit (LEL) for the fuel and/or fuel additive(s) that are
being tested be determined. These limits can be found in the material
safety data sheets (MSDS) for each substance and in various reference
texts. The air concentration of the fuel or additive-base fuel mixture
in the generation system, dilution/delivery system, and the exposure
chamber system shall be calculated to ensure that explosive limits are
not present.
(ii) Storage, handling, and use of fuels or fuel/additive mixtures
shall follow guidelines given in 29 CFR 1910.106.
(iii) Monitoring for carbon monoxide (CO) levels is mandatory for
combustion systems. CO shall be continuously monitored in the immediate
area of the engine/vehicle system and in the exposure chamber(s).
(iv) Air samples shall be taken quarterly in the immediate area of
the vapor generation system and the exposure chamber system, or once at
the beginning, middle, and end of the study for shorter studies. These
samples shall be analyzed by methods described in paragraph
(d)(6)(ii)(B) of this section.
(v) With the presence of fuels and/or fuel additives, all electrical
and electronic equipment must be grounded. Also, the dilution/delivery
system and chamber exposure system must be grounded. Guidelines for
grounding are given in 29 CFR 1910.304.
(9) Quality control and quality assurance procedures--(i) Standard
operating procedures (SOPs). SOPs for exposure operations, sampling
instruments, animal handling, and analytical methods shall be written
during the developmental phase of the study.
[[Page 77]]
(ii) Technicians/operators shall be trained in exposure operation,
maintenance, and documentation, as appropriate, and their training shall
be documented.
(iii) Flow meters, sampling instruments, and balances used in the
inhalation experiments shall be calibrated with standards during the
developmental phase to determine their sensitivity, detection limits,
and linearity. During the exposure period, instruments shall be checked
for calibration and documented to ensure that each instrument still
functions properly.
(iv) The mean exposure concentration shall be within 10 percent of
the target concentration on 90 percent or more of exposure days. The
coefficient of variation shall be within 25 percent of target on 90
percent or more of exposure days. For example, a manufacturer might
determine a mean exposure concentration of its product's exposure
emissions by identifying ``marker'' compound(s) typical of the emissions
of the fuel or fuel/additive mixture under study as a surrogate for the
total of individual compounds in those exposure emissions. The
manufacturer would note any concentration changes in the level of the
``marker'' compound(s) in the sample's daily emissions for biological
testing.
(v) The spatial variation of the chamber concentration shall be 10
percent, or less. If a higher spatial variation is observed during the
developmental phase, then air mixing in the chamber shall be increased.
In any case, animals shall be rotated among the various cages in the
exposure chamber(s) to insure each animal's uniform exposure during the
study.
(e) Data and reporting. Data shall be summarized in tabular form,
showing for each group the number of animals at the start of the test,
the number of animals showing lesions, the types of lesions, and the
percentage of animals displaying each type of lesion.
(1) Treatment of results. All observed results, quantitative and
incidental, shall be evaluated by an appropriate statistical method. Any
generally accepted statistical method may be used; the statistical
methods shall be selected during the design of the study.
(2) Evaluation of results. The findings of an inhalation toxicity
study should be evaluated in conjunction with the findings of preceding
studies and considered in terms of the observed toxic effects and the
necropsy and histopathological findings. The evaluation will include the
relationship between the concentration of the test atmosphere and the
duration of exposure, and the severity of abnormalities, gross lesions,
identified target organs, body weight changes, effects on mortality and
any other general or specific toxic effects.
(3) Test conditions. (i) The exposure apparatus shall be described,
including:
(A) The vehicle/engine design and type, the dynamometer, the cooling
system, if any, the computer control system, and the dilution system for
exhaust emission generation;
(B) The evaporative emissions generator model, type, or design and
its dilution system; and
(C) Other test conditions, such as the source and quality of mixing
air, fuel or fuel/additive mixture used, treatment of exhaust air,
design of exposure chamber and the method of housing animals in a test
chamber shall be described.
(ii) The equipment for measuring temperature, humidity, particulate
aerosol concentrations and size distribution, gas analyzers, fuel vapor
concentrations, chamber distribution, and rise and fall time shall be
described.
(iii) Daily exposure results. The daily record shall document the
date, the start and stop times of the exposure, number of samples taken
during the day, daily concentrations determined, calibration of
instruments, and problems encountered during the exposure. The daily
exposure data shall be signed by the exposure operator and reviewed and
signed by the exposure supervisor responsible for the study.
(4) Exposure data shall be tabulated and presented with mean values
and a measure of variability (e.g., standard deviation), and shall
include:
(i) Airflow rates through the inhalation equipment;
(ii) Temperature and humidity of air;
(iii) Chamber concentrations in the chamber breathing zone;
[[Page 78]]
(iv) Concentration of combustion exhaust gases in the chamber
breathing zone;
(v) Particle size distribution (e.g., mass median aerodynamic
diameter and geometric standard deviation from the mean);
(vi) Rise and fall time;
(vii) Chamber concentrations during the non-exposure period; and
(viii) Distribution of test substance in the chamber.
(5) Animal data. Tabulation of toxic response data by species,
strain, sex and exposure level for:
(i) Number of animals exposed;
(ii) Number of animals showing signs of toxicity; and
(iii) Number of animals dying.
(f) References. For additional background information on this
exposure guideline, the following references should be consulted.
(1) Barr, E.B. (1988) Operational Limits for Temperature and Percent
Oxygen During HM Nose-Only Exposures--Emergency Procedures [interoffice
memorandum]. Albuquerque, NM: Lovelace Inhalation Toxicology Research
Institute; May 13.
(2) Barr, E.B.; Cheng, Y.S.; Mauderly, J.L. (1990) Determination of
Oxygen Depletion in a Nose-Only Exposure Chamber. Presented at: 1990
American Association for Aerosol Research; June; Philadelphia, PA:
American Association for Aerosol Research; abstract no. P2e1.
(3) Barrow, C.S. (1989) Generation and Characterization of Gases and
Vapors. In: McClellan, R.O., Henderson, R.F. ed. Concepts in Inhalation
Toxicology. New York, NY: Hemisphere Publishing Corp., 63-84.
(4) Benedict, R.P. (1984) Fundamentals of Temperature, Pressure, and
Flow Measurements. 3rd ed. New York, NY: John Wiley and Sons.
(5) Cannon, W.C.; Blanton, E.F.; McDonald, K.E. The Flow-Past
Chamber. (1983) An Improved Nose-Only Exposure System for Rodents. Am.
Ind. Hyg. Assoc. J. 44: 923-928.
(6) Chaddock, J.B. ed. (1985) Moisture and humidity. Measurement and
Control in Science and Industry: Proceedings of the 1985 International
Symposium on Moisture and Humidity; April 1985; Washington, D.C.
Research Triangle Park, NC: Instrument Society of America.
(7) Cheng, Y.S.; Barr, E.B.; Carpenter, R.L.; Benson, J.M.; Hobbs,
C.H. (1989) Improvement of Aerosol Distribution in Whole-Body Inhalation
Exposure Chambers. Inhal. Toxicol. 1: 153-166.
(8) Cheng,Y.S.; Moss, O.R. (1989) Inhalation Exposure Systems. In:
McClellan, R.O.; Henderson, R.F. ed. Concepts in Inhalation Toxicology.
New York, NY: Hemisphere Publishing Corp., 19-62.
(9) Cheng, Y.S.; Yeh, H.C.; Mauderly, J.L.; Mokler, B.V. (1984)
Characterization of Diesel Exhaust in a Chronic Inhalation Study. Am.
Ind. Hyg. Assoc. J. 45: 547-555.
(10) Gillum, D.R. (1982) Industrial Pressure Measurement. Research
Triangle Park, NC: Instrument Society of America.
(11) Hinners, R.G.; Burkart, J.K.; Malanchuk, M. (1979) Animal
Exposure Facility for Diesel Exhaust Studies.
(12) Kittelson, D.B.; Dolan, D.F. (1979) Diesel exhaust aerosols. In
Willeke, K. ed. Generation of Aerosols and Facilities for Exposure
Experiments. Ann Arbor, MI: Ann Arbor Science Publishers Inc., 337-360.
(13) Mokler, B.V.; Archibeque, F.A.; Beethe, R.L.; Kelly, C.P.J.;
Lopez, J.A.; Mauderly, J.L.; Stafford, D.L. (1984) Diesel Exhaust
Exposure System for Animal Studies. Fundamental and Applied Toxicology
4: 270-277.
(14) Moore, W.; et al. (1978) Preliminary finding on the Deposition
and Retention of Automotive Diesel Particulate in Rat Lungs. Proc. of
Annual Meeting of the Air Pollution Control Assn, 3, paper 78-33.7.
(15) Raabe, O.G., Bennick, J.E., Light, M.E., Hobbs, C.H., Thomas,
R.L., Tillery, M.I. (1973) An Improved Apparatus for Acute Inhalation
Exposure of Rodents to Radioactive Aerosols. Toxicol & Applied
Pharmaco.; 1973; 26: 264-273.
(16) Rao, G.N. (1986) Significance of Environmental Factors on the
Test System. In: Hoover, B.K.; Baldwin, J.K.; Uelner, A.F.; Whitmire,
C.E.; Davies, C.L.; Bristol, D.W. ed. Managing conduct and data quality
of toxicology studies. Raleigh, NC: Princeton Scientific Publishing Co.,
Inc.: 173-185.
[[Page 79]]
(17) Spitzer, D.W. (1984) Industrial Flow Measurement. Research
Triangle Park, NC: Instrument Society of America.
(18) 40 CFR part 798, Health effects testing guidelines.
(19) 29 CFR part 1910, Occupational safety and health standards for
general industry.
(20) Federal Register, 42 FR 26748, May 25, 1977.
[59 FR 33093, June 27, 1994, as amended at 61 FR 58746, Nov. 18, 1996;
61 FR 36512, July 11, 1996]
Sec. 79.62 Subchronic toxicity study with specific health effect
assessments.
(a) Purpose--(1) General toxicity. This subchronic inhalation study
is designed to determine a concentration-response relationship for
potential toxic effects in rats resulting from continuous or repeated
inhalation exposure to vehicle/engine emissions over a period of 90
days. A subgroup of perfusion-fixed animals is required, in addition to
the main study population, for more exacting organ and tissue histology.
This test will provide screening information on target organ toxicities
and on concentration levels useful for running chronic studies and
establishing exposure criteria. Initial information on effective
concentrations/exposures of the test atmosphere may be determined from
the literature of previous studies or through concentration range-
finding trials prior to starting this study. This health effects
screening test is not capable of directly determining those effects
which have a long latency period for development (e.g., carcinogenicity
and life-shortening), though it may permit the detremination of a no-
observed-adverse-effect level, or NOAEL.
(2) Specific health effects assessments (HEAs). These supplemental
studies are designed to determine the potential for reproductive/
teratologic, carcinogenic, mutagenic, and neurotoxic health effect
outcomes from vehicle/engine emission exposures. They are done in
combination with the subchronic toxicity study and paragraph (c) of this
section or may be done separately as outlined by the appropriate test
guideline.
(i) Fertility assessment/teratology. The fertility assessment is an
in vivo study designed to provide information on potential health
hazards to the fetus arising from the mother's repeated exposure to
vehicle/engine emissions before and during her pregnancy. By including a
mating of test animals, the study provides preliminary data on the
effects of repeated vehicle/engine emissions exposure on gonadal
function, conception, and fertility. The fertility assessment/teratology
guideline is found in Sec. 79.63.
(ii) Micronucleus (MN) Assay. The MN assay is an in vivo cytogenetic
test which gives information on potential carcinogenic and/or mutagenic
effects of exposure to vehicle/engine emissions. The MN assay detects
damage to the chromosomes or mitotic apparatus of cells in the tissues
of a test subject exposed repeatedly to vehicle/engine emissions. The
assay is based on an increase in the frequency of micronucleated
erythrocytes found in bone marrow from treated animals compared to that
of control animals. The guideline for the MN assay is found in Sec.
79.64.
(iii) Sister Chromatid Exchange (SCE) Assay. The SCE assay is an in
vivo analysis which gives information on potential mutagenic and/or
carcinogenic effects of exposure to vehicle/engine emissions. The assay
detects the ability of a chemical to enhance the exchange of DNA between
two sister chromatids of a duplicating chromosome. This assay uses
peripheral blood lymphocytes isolated from an exposed rodent test
species and grown to confluence in cell culture. The guideline for the
SCE assay is found in Sec. 79.65.
(iv) Neurotoxicity (NTX) measures. NTX measures include (A)
histopathology of specified central and peripheral nervous system
tissues taken from emission-exposed rodents, and (B) an assay of brain
tissue levels of glial fibrillary acidic protein (GFAP), a major
filament protein of astrocytes, from emission-exposed rodents. The
guidelines for the neurohistopathology and GFAP studies are found in
Sec. 79.66 and Sec. 79.67, respectively.
(b) Definitions. For the purposes of this section, the following
definitions apply:
[[Page 80]]
No-observed-adverse-effect-level (NOAEL) means the maximum
concentration used in a test which produces no observed adverse effects.
A NOAEL is expressed in terms of weight or volume of test substance
given daily per unit volume of air ([micro]g/L or ppm).
Subchronic inhalation toxicity means the adverse effects occurring
as a result of the continuous or repeated daily exposure of experimental
animals to a chemical by inhalation for part (approximately 10 percent)
of a life span.
(c) Principle of the test method. As long as none of the
requirements of any study are violated by the combination, one or more
HEAs may be combined with the general toxicity study through concurrent
exposures of their study populations and/or by sharing the analysis of
the same animal subjects. Requirements duplicated in combined studies
need not be repeated. Guidelines for combining HEAs with the general
toxicity study are as follows.
(1) Fertility assessment. (i) The number of study animals in the
test population is increased when the fertility assessment is run
concurrently with the 90-day toxicity study. A minimum of 40 females per
test group shall undergo vaginal lavage daily for two weeks before the
start of the exposure period. The resulting wet smears are examined to
cull those animals which are acyclic. Twenty-five females shall be
randomly assigned to a for-breeding group with the balance of females
assigned to a group for histopathologic examination.
(ii) All test groups are exposed over a period of 90 days to various
concentrations of the test atmosphere for a minimum of six hours per
day. After seven weeks of exposures, analysis of vaginal cell smears
shall resume on a daily basis for the 25 for-breeding females and shall
continue for a period of four weeks or until each female in the group is
confirmed pregnant. Following the ninth week of exposures, each for-
breeding female is housed overnight with a single study male. Matings
shall continue for as long as two weeks, or until pregnancy is confirmed
(pregnancy day 0). Pregnant females are only exposed through day 15 of
their pregnancy while daily exposures continue throughout the course of
the study for non-pregnant females and study males.
(iii) On pregnancy day 20, pregnant females are sacrificed and their
uteri are examined. Pregnancy status and fetal effects are recorded as
described in Sec. 79.63. At the end of the exposure period, all males
and non-pregnant females are sacrificed and necropsied. Testes and
epididymal tissue samples are taken from five perfusion-fixed test
subjects and histopathological examinations are carried out on the
remainder of the non-pregnant females and study males.
(2) Carcinogenicity/mutagenicity(C/M) assessment. When combined with
the subchronic toxicity study, the main study population is used to
perform both the in vivo MN and SCE assays. Because of the constant
turnover of the cells to be analyzed in these assays, a separate study
population may be used for this assessment. A study population needs
only to be exposed a minimum of four weeks. At exposure's end, ten
animals per exposure and control groups are anaesthetized and heart
punctures are performed on all members. After separating blood
components, individual lymphocyte cell cultures are set up for SCE
analysis. One femur from each study subject is also removed and the
marrow extracted. The marrow is smeared onto a glass slide, and stained
for analysis of micronuclei in erythrocytes.
(3) Neurotoxicity (NTX) measures. (i) When combined with this
subchronic toxicity study, test animals designated for whole-body
perfusion fixation/lung histology and exposed as part of the main animal
population are used to perform the neurohistology portion of these
measures. After the last exposure period, a minimum of ten animals from
each exposure group shall be preserved in situ with fixative. Sections
of brain, spinal cord, and proximal sciatic or tibial nerve are then
cut, processed further in formalin, and mounted for viewing under a
light microscope. Fibers from the sciatic or tibial nerve sample are
teased apart for further analysis under the microscope.
(ii) GFAP assay. After the last exposure period, a minimum of ten
rodents
[[Page 81]]
from each exposure group shall be sacrificed, and their brains excised
and divided into regions. The tissue samples are then applied to filter
paper, washed with anti-GFAP antibody, and visualized with a radio-
labelled Protein A. The filters are quantified for degree of
immunoreactivity between the antibody and GFAP in the tissue samples. A
non-radioactive ELISA format is also referenced in the GFAP guideline
cited in paragraph (a)(2)(iv) of this section. Note: Because the GFAP
assay requires fresh, i.e., non-preserved, brain tissue, the number of
test animals may need to be increased to provide an adequate number of
test subjects to complete the histopathology requirements of both the
GFAP and the general toxicity portion of the 90-day inhalation study.
(iii) The start of the exposure period for the NTX measures study
population may be staggered from that of the main study group to more
evenly distribute the analytical work required in both study
populations. The exposures would remain the same in all other respects.
(d) Test procedures--(1) Animal selection--(i) Species and sex. The
rat is the recommended species. If another rodent species is used, the
tester shall provide justification for its selection. Both sexes shall
be used in any assessment unless it is demonstrated that one sex is
refractory to the effects of exposure.
(ii) Age and number. Rats shall be at least ten weeks of age at the
beginning of the study exposure. The number of animals necessary for
individual health effect outcomes is as follows:
(A) Thirty rodents per concentration level/group, fifteen of each
sex, shall be used to satisfy the reporting requirements of the 90-day
toxicity study. Ten animals per concentration level/group shall be
designated for whole body perfusion with fixative (by gravity) for lung
studies, and neurohistology and testes studies, as appropriate.
(B) Thirty-five rodents, 25 females and ten males, shall be added
for each test concentration or control group when combining a 90-day
toxicity study with a fertility assessment.
(C) The tester shall provide a group of 10 animals (five animals per
sex per experimental/control groups) in addition to the main test
population when performing the GFAP neurotoxicity HEA.
(2) Recovery group. The manufacturer shall include a group of 20
animals (10 animals per sex) in the test population, exposing them to
the highest concentration level for the entire length of the study's
exposure period. This group shall then be observed for reversibility,
persistence, or delayed occurrence of toxic effects during a post-
exposure period of not less than 28 days.
(3) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(4) Observation of animals. (i) All toxicological (e.g., weight
loss) and neurological signs (e.g., motor disturbance) shall be recorded
frequently enough to observe any abnormality, and not less than weekly
for all study animals. Animals shall be weighed weekly.
(ii) The following is a minimal list of measures that shall be
noted:
(A) Body weight;
(B) Subject's reactivity to general stimuli such as removal from the
cage or handling;
(C) Description, incidence, and severity of any convulsions,
tremors, or abnormal motor movements in the home cage;
(D) Descriptions and incidence of posture and gait abnormalities
observed in the home cage;
(E) Description and incidence of any unusual or abnormal behaviors,
excessive or repetitive actions (stereotypies), emaciation, dehydration,
hypotonia or hypertonia, altered fur appearance, red or crusty deposits
around the eyes, nose, or mouth, and any other observations that may
facilitate interpretation of the data.
(iii) Any animal which dies during the test is necropsied as soon as
possible after discovery.
(5) Clinical examinations. (i) The following examinations shall be
performed on the twenty animals designated as the 90-day study
population, exclusive of pregnant dams and those
[[Page 82]]
study animals targeted for perfusion by gravity:
(A) The following hematology determinations shall be carried out at
least two times during the test period (after 30 days of exposure and
just prior to terminal sacrifice at the end of the exposure period):
hematocrit, hemoglobin concentration, erythrocyte count, total and
differential leukocyte count, and a measure of clotting potential such
as prothrombin time, thromboplastin time, or platelet count.
(B) Clinical biochemistry determinations on blood shall be carried
out at least two times during the test period, after 30 days of exposure
and just prior to terminal sacrifice at the end of the exposure period,
on all groups of animals including concurrent controls. Clinical
biochemical testing shall include assessment of electrolyte balance,
carbohydrate metabolism, and liver and kidney function. The selection of
specific tests will be influenced by observations on the mode of action
of the substance. In the absence of more specific tests, the following
determinations may be made: calcium, phosphorus, chloride, sodium,
potassium, fasting glucose (with period of fasting appropriate to the
species), serum alanine aminotransferase, serum aspartate
aminotransferase, sorbitol dehydrogenase, gamma glutamyl transpeptidase,
urea nitrogen, albumen, blood creatinine, methemoglobin, bile acids,
total bilirubin, and total serum protein measurements. Additional
clinical biochemistry shall be employed, where necessary, to extend the
investigation of observed effects, e.g., analyses of lipids, hormones,
acid/base balance, and cholinesterase activity.
(ii) The following examinations shall initially be performed on the
high concentration and control groups only:
(A) Ophthalmological examination, using an ophthalmoscope or
equivalent suitable equipment, shall be made prior to exposure to the
test substance and at the termination of the study. If changes in the
eyes are detected, all animals shall be examined.
(B) Urinalysis is not required on a routine basis, but shall be done
when there is an indication based on expected and/or observed toxicity.
(iii) Preservation by whole-body perfusion of fixative into the
anaesthetized animal for lung histology of ten animals from the 90-day
study population for each experimental and control group.
(6) Gross pathology. With the exception of the whole body perfusion-
fixed test animals cited in paragraph (d)(1)(ii)(A) of this section, all
rodents shall be subjected to a full gross necropsy which includes
examination of the external surface of the body, all orifices and the
cranial, thoracic, and abdominal cavities and their contents. Gross
pathology shall be performed on the following organs and tissues:
(i) The liver, kidneys, lungs, adrenals, brain, and gonads,
including uterus, ovaries, testes, epididymides, seminal vesicles (with
coagulating glands), and prostate, constitute the group of target organs
for histology and shall be weighed as soon as possible after dissection
to avoid drying. In addition, for other than rodent test species, the
thyroid with parathyroids, when present, shall also be weighed as soon
as possible after dissection to avoid drying.
(ii) The following organs and tissues, or representative samples
thereof, shall be preserved in a suitable medium for possible future
histopathological examination: All gross lesions; lungs--which shall be
removed intact, weighed, and treated with a suitable fixative to ensure
that lung structure is maintained (perfusion with the fixative is
considered to be an effective procedure); nasopharyngeal tissues;
brain--including sections of medulla/pons, cerebellar cortex, and
cerebral cortex; pituitary; thyroid/parathyroid; thymus; trachea; heart;
sternum with bone marrow; salivary glands; liver; spleen; kidneys;
adrenals; pancreas; reproductive organs: uterus; cervix; ovaries;
vagina; testes; epididymides; prostate; and, if present, seminal
vesicles; aorta; (skin); gall bladder (if present); esophagus; stomach;
duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder;
representative lymph node; (mammary gland); (thigh musculature);
peripheral nerve/tissue; (eyes); (femur--including articular surface);
(spinal cord at three
[[Page 83]]
levels--cervical, midthoracic, and lumbar); and (zymbal and exorbital
lachrymal glands).
(7) Histopathology. Histopathology shall be performed on the
following organs and tissues from all rodents:
(i) All gross lesions.
(ii) Respiratory tract and other organs and tissues, listed in
paragraph (d)(6)(ii) of this section (except organs/tissues in
parentheses), of all animals in the control and high dose groups.
(iii) The tissues mentioned in parentheses, listed in paragraph
(d)(6)(ii) of this section, if indicated by signs of toxicity or target
organ involvement.
(iv) Lungs of animals in the low and intermediate dose groups shall
also be subjected to histopathological examination, primarily for
evidence of infection since this provides a convenient assessment of the
state of health of the animals.
(v) Lungs and trachea of the whole-body perfusion-fixed test animals
cited in paragraph (d)(1)(ii)(A) of this section are examined for
inhaled particle distribution.
(e) Interpretation of results. All observed results, quantitative
and incidental, shall be evaluated by an appropriate statistical method.
The specific methods, including consideration of statistical power,
shall be selected during the design of the study.
(f) Test report. In addition to the reporting requirements as
specified under Sec. Sec. 79.60 and 79.61(e), the following individual
animal data information shall be reported:
(1) Date of death during the study or whether animals survived to
termination.
(2) Date of observation of each abnormal sign and its subsequent
course.
(3) Individual body weight data, and group average body weight data
vs. time.
(4) Feed consumption data, when collected.
(5) Hematological tests employed and all results.
(6) Clinical biochemistry tests employed and all results.
(7) Necropsy findings.
(8) Type of stain/fixative and procedures used in preparing tissue
samples.
(9) Detailed description of all histopathological findings.
(10) Statistical treatment of the study results, where appropriate.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.2450, Inhalation toxicity.
(2) 40 CFR 798.2675, Oral Toxicity with Satellite Reproduction and
Fertility Study.
(3) General Statement of Work for the Conduct of Toxicity and
Carcinogenicity Studies in Laboratory Animals (revised April, 1987/
modifications through January, 1990) appendix G, National Toxicology
Program--U.S. Dept. of Health and Human Services (Public Health
Service), P.O. Box 12233, Research Triangle Park, NC 27709.
[59 FR 33093, June 27, 1994, as amended at 63 FR 63793, Nov. 17, 1998]
Sec. 79.63 Fertility assessment/teratology.
(a) Purpose. Fertility assessment/teratology is an in vivo study
designed to provide information on potential health hazards to the fetus
arising from the mother's repeated inhalation exposure to vehicle/engine
emissions before and during her pregnancy. By including a mating of test
animals, the study provides preliminary data on the effects of repeated
vehicle/engine emissions exposure on gonadal function, conception, and
fertility. Since this is a one-generation test that ends with
examination of full-term fetuses, but not of live pups, it is not
capable of determining effects on reproductive development which would
only be detected in viable offspring of treated parents.
(b) Definitions. For the purposes of this section, the following
definitions apply:
Developmental toxicity means the ability of an agent to induce in
utero death, structural or functional abnormalities, or growth
retardation after contact with the pregnant animal.
Estrous cycle means the periodic recurrence of the biological phases
of the female reproductive system which prepare the animal for
conception and the development of offspring. The phases of the estrous
cycle for a particular animal can be characterized by the general
condition of the cells present in
[[Page 84]]
the vagina and the presence or absence of various cell types.
Vaginal cytology evaluation means the use of wet vaginal cell smears
to determine the phase of a test animal's estrous cycle and the
potential for adverse exposure effects on the regularity of the animal's
cycle. In the rat, common cell types found in the smears correlate well
with the various stages of the estrous cycle and to changes occurring in
the reproductive tract.
(c) Principle of the test method. (1) For a two week period before
exposures start, daily vaginal cell smears are examined from a surplus
of female test animals to identify and cull those females which are
acyclic. After culling, testers shall randomly assign at each exposure
concentration (including unexposed) a minimum of twenty-five females for
breeding and fifteen non-bred females for later histologic evaluation.
Test animals shall be exposed by inhalation to graduated concentrations
of the test atmosphere for a minimum of six hours per day over the next
13 weeks. Males and females in both test and control groups are mated
after nine weeks of exposure. Exposures for pregnant females continue
through gestation day 15, while exposures for males and all non-pregnant
females shall continue for the full exposure period.
(2) Beginning two weeks before the start of the mating period, daily
vaginal smears resume for all to-be-bred females to characterize their
estrous cycles. This will continue for four weeks or until a rat's
pregnancy is confirmed, i.e., day 0, by the presence of sperm in the
cell smear. On pregnancy day 20, shortly before the expected date of
delivery, each pregnant female is sacrificed, her uterus removed, and
the contents examined for embryonic or fetal deaths, and live fetuses.
At the end of the exposure period, males and all non-pregnant females
shall be weighed, and various organs and tissues, as appropriate, shall
be removed and weighed, fixed with stain, and sectioned for viewing
under a light microscope.
(3) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions in Sec. 79.62.
(d) Limit test. If a test at one dose level of the highest
concentration that can be achieved while maintaining a particle size
distribution with a mass median aerodynamic diameter (MMAD) of 4
micrometers ([micro]m) or less, using the procedures described in
section 79.60 of this part produces no observable toxic effects and if
toxicity would not be expected based upon data of structurally related
compounds, then a full study using three dose levels might not be
necessary. Expected human exposure though may indicate the need for a
higher dose level.
(e) Test procedures--(1) Animal selection--(i) Species and strain.
The rat is the preferred species. Strains with low fecundity shall not
be used and the candidate species shall be characterized for its
sensitivity to developmental toxins. If another rodent species is used,
the tester shall provide justification for its selection.
(ii) Animals shall be a minimum of 10 weeks old at the start of the
exposure period.
(iii) Number and sex. Each test and control group shall have a
minimum of 25 males and 40 females. In order to ensure that sufficient
pups are produced to permit meaningful evaluation of the potential
developmental toxicity of the test substance, twenty pregnant test
animals are required for each exposure and control level.
(2) Observation period. The observation period shall be 13 weeks, at
a minimum.
(3) Concentration levels and concentration selection. (i) To select
the appropriate concentration levels, a pilot or trial study may be
advisable. Since pregnant animals have an increased minute ventilation
as compared to non-pregnant animals, it is recommended that the trial
study be conducted in pregnant animals. Similarly, since presumably the
minute ventilation will vary with progression of pregnancy, the animals
should be exposed during the same period of gestation as in the main
study. It is not always necessary, though, to carry out a trial study in
pregnant animals. Comparisons between the results of a trial study in
non-pregnant animals, and the main study in pregnant animals will
demonstrate whether or not the test
[[Page 85]]
substance is more toxic in pregnant animals. In the trial study, the
concentration producing embryonic or fetal lethalities or maternal
toxicity should be determined.
(ii) The highest concentration level shall induce some overt
maternal toxicity such as reduced body weight or body weight gain, but
not more than 10 percent maternal deaths.
(iii) The lowest concentration level shall not produce any grossly
observable evidence of either maternal or developmental toxicity.
(4) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(iii) Pregnant females shall be exposed to the test atmosphere on
each and every day between (and including) the first and fifteenth day
of gestation.
(f) Test performance--(1) Study conduct. Directions specific to this
study are:
(i) The duration of exposure shall be at least six hours daily,
allowing appropriate additional time for chamber equilibrium.
(ii) Where an exposure chamber is used, its design shall minimize
crowding of the test animals. This is best accomplished by individual
caging.
(iii) Pregnant animals shall not be subjected to beyond the minimum
amount of stress. Since whole-body exposure appears to be the least
stressful mode of exposure, it is the preferred method. In general
oronasal or head-only exposure, which is sometimes used to avoid
concurrent exposure by the dermal or oral routes, is not recommended
because of the associated stress accompanying the restraining of the
animals. However, there may be specific instances where it may be more
appropriate than whole-body exposure. The tester shall provide
justification/reasoning for its selection.
(iv) Measurements shall be made at least every other day of food
consumption for all animals in the study. Males and females shall be
weighed on the first day of exposure and 2-3 times per week thereafter,
except for pregnant dams.
(v) The test animal housing, mating, and exposure chambers shall be
operated on a twenty-four hour lighting schedule, with twelve hours of
light and twelve hours of darkness. Test animal exposure shall only
occur during the light portion of the cycle.
(vi) Signs of toxicity shall be recorded as they are observed
including the time of onset, degree, and duration.
(vii) Females showing signs of abortion or premature delivery shall
be sacrificed and subjected to a thorough macroscopic examination.
(viii) Animals that die or are euthanized because of morbidity will
be necropsied promptly.
(2) Vaginal cytology. (i) For a two week period before the mating
period starts, each female in the to-be-bred population shall undergo a
daily saline vaginal lavage. Two wet cell smears from this lavage shall
be examined daily for each subject to determine a baseline pattern of
estrus. Testers shall avoid excessive handling and roughness in
obtaining the vaginal cell samples, as this may induce a condition of
pseudo-pregnancy in the test animals.
(ii) This will continue for four weeks or until day 0 of a rat's
pregnancy is confirmed by the presence of sperm in the cell smear.
(3) Mating and fertility assessment. (i) Beginning nine weeks after
the start of exposure, each exposed and control group female (exclusive
of the histology group females) shall be paired during non-exposure
hours with a male from the same exposure concentration group. Matings
shall continue for a period of two weeks, or until all mated females are
determined to be pregnant. Mating pairs shall be clearly identified.
(ii) Each morning, including weekends, cages shall be examined for
the presence of a sperm plug. When found, this shall mark gestation day
0 and pregnancy shall be confirmed by the presence of sperm in the day's
wet vaginal cell smears.
(iii) Two weeks after mating is begun, or as females are determined
to be pregnant, bred animals are returned to pre-mating housing. Daily
exposures continues through gestation day 15 for all pregnant females or
through the
[[Page 86]]
balance of the exposure period for non-pregnant females and all males.
(iv) Those pairs which fail to mate shall be evaluated in the course
of the study to determine the cause of the apparent infertility. This
may involve such procedures as additional opportunities to mate with a
proven fertile partner, histological examination of the reproductive
organs, and, in males, examination of the spermatogenic cycles. The
stage of estrus for each non-pregnant female in the breeding group will
be determined at the end of the exposure period.
(4) All animals in the histology group shall be subject to
histopathologic examination at the end of the study's exposure period.
(g) Treatment of results. (1) All observed results, quantitative and
incidental, shall be evaluated by an appropriate statistical method. The
specific methods, including consideration of statistical power, shall be
selected during the design of the study.
(2) Data and reporting. In addition to the reporting requirements
specified under Sec. Sec. 79.60 and 79.61, the final test report must
include the following information:
(i) Gross necropsy. (A) All animals shall be subjected to a full
necropsy which includes examination of the external surface of the body,
all orifices, and the cranial, thoracic, and abdominal cavities and
their contents. Special attention shall be directed to the organs of the
reproductive system.
(B) The liver, kidneys, adrenals, pituitary, uterus, vagina,
ovaries, testes, epididymides and seminal vesicles (with coagulating
glands), and prostate shall be weighed wet, as soon as possible after
dissection, to avoid drying.
(i) At the time of sacrifice on gestation day 20 or at death during
the study, each dam shall be examined macroscopically for any structural
abnormalities or pathological changes which may have influenced the
pregnancy.
(ii) The contents of the uterus shall be examined for embryonic or
fetal deaths and the number of viable fetuses. Gravid uterine weights
need not be obtained from dead animals where decomposition has occurred.
The degree of resorption shall be described in order to help estimate
the relative time of death.
(iii) The number of corpora lutea shall be determined in each
pregnant dam.
(iv) Each fetus shall be weighed, all weights recorded, and mean
fetal weights determined.
(v) Each fetus shall be examined externally and the sex determined.
(vi) One-half of the rat fetuses in each litter shall be examined
for skeletal anomalies, and the remaining half shall be examined for
soft tissue anomalies, using appropriate methods.
(ii) Histopathology. (A) Histopathology on vagina, uterus, ovaries,
testes, epididymides, seminal vesicles, and prostate as appropriate for
all males and histology group females in the control and high
concentration groups and for all animals that died or were euthanized
during the study. If abnormalities or equivocal results are seen in any
of these organs/tissues, the same organ/tissue from test animals in
lower concentration groups shall be examined.
Note: Testes, seminal vesicles, epididymides, and ovaries, at a
minimum, shall be examined in perfusion-fixed (pressure or gravity
method) test subjects, when available.
(B) All gross lesions in all study animals shall be examined.
(C) As noted under mating procedures, reproductive organs of animals
suspected of infertility shall be subject to microscopic examination.
(D) The following organs and tissues, or representative samples
thereof, shall be preserved in a suitable medium for future
histopathological examination: all gross lesions; vagina; uterus;
ovaries; testes; epididymides; seminal vesicles; prostate; liver; and
kidneys/adrenals.
(3) Evaluation of results. (i) The findings of a developmental
toxicity study shall be evaluated in terms of the observed effects and
the exposure levels producing effects. It is necessary to consider the
historical developmental toxicity data on the species/strain tested.
[[Page 87]]
(ii) There are several criteria for determining a positive result
for reproductive/teratologic effects; a statistically significant dose-
related decrease in the weight of the testes for treated subjects over
control subjects, a decrease in neonatal viability, a significant change
in the presence of soft tissue or skeletal abnormalities, or an
increased rate of embryonic or fetal resorption or death. Other
criteria, e.g., lengthening of the estrous cycle or the time spent in
any one stage of estrus, changes in the proportion of viable male vs
female fetuses or offspring, the number and type of cells in vaginal
smears, or pathologic changes found during gross or microscopic
examination of male or female reproductive organs may be based upon
detection of a reproducible and statistically significant positive
response for that evaluation parameter. A positive result indicates
that, under the test conditions, the test substance does induce
reproductive organ or fetal toxicity in the test species.
(iii) A test substance which does not produce either a statistically
significant dose-related change in the reproductive organs or cycle or a
statistically significant and reproducible positive response at any one
of the test points may not induce reproductive organ toxicity in this
test species, but further investigation , e.g., to establish absorption
and bioavailability of the test substance, should be considered.
(h) Test report. In addition to the reporting requirements as
specified under 40 CFR 79.60 and the vehicle emissions inhalation
toxicity guideline as published in 40 CFR 79.61, the following specific
information shall be reported:
(1) Individual animal data. (i) Time of death during the study or
whether animals survived to termination.
(ii) Date of onset and duration of each abnormal sign and its
subsequent course.
(iii) Feed and body weight data.
(iv) Necropsy findings.
(v) Male test subjects.
(A) Testicle weight, and body weight: testicle weight ratio.
(B) Detailed description of all histopathological findings,
especially for the testes and the epididymides.
(vi) Female test subjects.
(A) Uterine weight data.
(B) Beginning and ending collection dates for vaginal cell smears.
(C) Estrous cycle length compared within and between groups
including mean cycle length for groups.
(D) Percentage of time spent in each stage of cycle.
(E) Stage of estrus at time of mating/sacrifice and proportion of
females in estrus between concentration groups.
(F) Detailed description of all histopathological findings,
especially for uterine/ovary samples.
(vii) Pregnancy and litter data. Toxic response data by exposure
level, including but not limited to, indices of fertility and time-to-
mating, including the number of days until mating and the number of full
or partial estrous cycles until mating.
(A) Number of pregnant animals,
(B) Number and percentage of live fetuses, resorptions.
(viii) Fetal data. (A) Numbers of each sex.
(B) Number of fetuses with any soft tissue or skeletal
abnormalities.
(2) Type of stain/fixative and procedures used in preparing tissue
samples.
(3) Statistical treatment of the study results.
(i) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.2675, Oral Toxicity with Satellite Reproduction and
Fertility Study.
(2) 40 CFR 798.4350, Inhalation Developmental Toxicity Study.
(3) Chapin, R.E. and J.J. Heindel (1993) Methods in Toxicology, Vol.
3, Parts A and B: Reproductive Toxicology, Academic Press, Orlando, FL.
(4) Gray, L.E., et al. (1989) ``A Dose-Response Analysis of
Methoxychlor-Induced Alterations of Reproductive Development and
Function in the Rat'' Fund. App. Tox. 12, 92-108.
(5) Leblond, C.P. and Y. Clermont (1952) ``Definition of the Stages
of the Cycle of the Seminiferous Epithelium of the Rat.'' Ann. N. Y.
Acad. Sci. 55:548-73.
(6) Morrissey, R.E., et al. (1988) ``Evaluation of Rodent Sperm,
Vaginal Cytology, and Reproductive Organ Weight Data from National
Toxicology
[[Page 88]]
Program 13-week Studies.'' Fundam. Appl. Toxicol. 11:343-358.
(7) Russell, L.D., Ettlin, R.A., Sinhattikim, A.P., and Clegg, E.D
(1990) Histological and Histopathological Evaluation of the Testes,
Cache River Press, Clearwater, FL.
[59 FR 33093, June 27, 1994, as amended at 61 FR 36513, July 11, 1996]
Sec. 79.64 In vivo micronucleus assay.
(a) Purpose. The micronucleus assay is an in vivo cytogenetic test
which uses erythrocytes in the bone marrow of rodents to detect chemical
damage to the chromosomes or mitotic apparatus of mammalian cells. As
the erythroblast develops into an erythrocyte (red blood cell), its main
nucleus is extruded and may leave a micronucleus in the cell body; a few
micronuclei form under normal conditions in blood elements. This assay
is based on an increase in the frequency of micronucleated erythrocytes
found in bone marrow from treated animals compared to that of control
animals. The visualization of micronuclei is facilitated in these cells
because they lack a main nucleus.
(b) Definitions. For the purposes of this section the following
definitions apply:
Micronuclei mean small particles consisting of acentric fragments of
chromosomes or entire chromosomes, which lag behind at anaphase of cell
division. After telophase, these fragments may not be included in the
nuclei of daughter cells and form single or multiple micronuclei in the
cytoplasm.
Polychromatic erythrocyte (PCE) means an immature red blood cell
that, because it contains RNA, can be differentiated by appropriate
staining techniques from a normochromatic erythrocyte (NCE), which lacks
RNA. In one to two days, a PCE matures into a NCE.
(c) Test method--(1) Principle of the test method. (i) Groups of
rodents are exposed by the inhalation route for a minimum of 6 hours/day
over a period of not less than 28 days to three or more concentrations
of a test substance in air. Groups of animals are sacrificed at the end
of the exposure period and femoral bone marrow is extracted. The bone
marrow is then smeared onto glass slides, stained, and PCEs are scored
for micronuclei. Researchers may need to run a trial at the highest
tolerated concentration of the test atmosphere to optimize the sample
collection time for micronucleated cells.
(ii) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions in Sec. 79.62.
(2) Species and strain. (i) The rat is the recommended test animal.
Other rodent species may be used in this assay, but use of that species
will be justified by the tester.
(ii) If a strain of mouse is used in this assay, the tester shall
sample peripheral blood from an appropriate site on the test animal,
e.g., the tail vein, as a source of normochromatic erythrocytes. Results
shall be reported as outlined later in this guideline with
``normochromatic'' interchanged for ``polychromatic'', where specified.
(3) Animal number and sex. At least five female and five male
animals per experimental/sample and control group shall be used. The use
of a single sex or a smaller number of animals shall be justified.
(4) Positive control group. A single concentration of a compound
known to produce micronuclei in vivo is adequate as a positive control
if it shows a significant response at any one time point; additional
concentration levels may be used. To select an appropriate concentration
level, a pilot or trial study may be advisable. Initially, one
concentration of the test substance may be used, the maximum tolerated
dose or that producing some indication of toxicity, e.g., a drop in the
ratio of polychromatic to normochromatic erythrocytes. Intraperitoneal
injection of 1,2-dimethyl-benz-anthracene or benzene are examples of
positive control exposures. A concentration of 50-80 percent of an LD50
may be a suitable guide.
(d) Test performance--(1) Inhalation exposure. (i) All data
developed within this study shall be in accordance with good laboratory
practice provisions under Sec. 79.60.
[[Page 89]]
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(2) Preparation of slides and sampling times. Within twenty-four
hours of the last exposure, test animals will be sacrificed. One femur
from each test animal will be removed and placed in fetal bovine serum.
The bone marrow is removed, cells processed, and two bone marrow smears
are made for each animal on glass microscope slides. The slides are
stained with acridine- orange (AO) or another appropriate stain (Giemsa
+ Wright's, etc.) and examined under a microscope.
(3) Analysis. Slides shall be coded for study before microscopic
analysis. At least 1,000 first-division erythrocytes per animal shall be
scored for the incidence of micronuclei. Sexes will be analyzed
separately.
(e) Data and report--(1) Treatment of results. In addition to the
reporting requirements specified under Sec. Sec. 79.60 and 79.61, the
final test report must include the criteria for scoring micronuclei.
Individual data shall be presented in a tabular form including both
positive and negative controls and experimental groups. The number of
polychromatic erythrocytes scored, the number of micronucleated
erythrocytes, the percentage of micronucleated cells, and, where
applicable, the percentage of micronucleated erythrocytes shall be
listed separately for each experimental and control animal. Absolute
numbers shall be included if percentages are reported.
(2) Interpretation of data. (i) There are several criteria for
determining a positive response, one of which is a statistically
significant dose-related increase in the number of micronucleated
polychromatic erythrocytes. Another criterion may be based upon
detection of a reproducible and statistically significant positive
response for at least one of the test substance concentrations.
(ii) A test substance which does not produce either a statistically
significant dose-related increase in the number of micronucleated
polychromatic erythrocytes or a statistically significant and
reproducible positive response at any one of the test points is
considered nonmutagenic in this system.
(3) Test evaluation. (i) Positive results in the micronucleus test
provide information on the ability of a chemical to induce micronuclei
in erythrocytes of the test species under the conditions of the test.
This damage may have been the result of chromosomal damage or damage to
the mitotic apparatus.
(ii) Negative results indicate that under the test conditions the
test substance does not produce micronuclei in the bone marrow of the
test species.
(f) Test report. In addition to the reporting recommendations as
specified under Sec. 79.60, the following specific information shall be
reported:
(1) Test atmosphere concentration(s) used and rationale for
concentration selection.
(2) Rationale for and description of treatment and sampling
schedules, toxicity data, negative and positive controls.
(3) Historical control data (negative and positive), if available.
(4) Details of the protocol used for slide preparation.
(5) Criteria for identifying micronucleated erythrocytes.
(6) Micronucleus analysis by animal and by group for each
concentration (sexes analyzed separately).
(i) Ratio of polychromatic to normochromatic erythrocytes.
(ii) Number of polychromatic erythrocytes with micronuclei.
(iii) Number of polychromatic erythrocytes scored.
(7) Statistical methodology chosen for test analysis.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.5395, In Vivo, Mammalian Bone Marrow Cytogenetics
Tests: Micronucleus Assay.
(2) Cihak, R. ``Evaluation of Benzidine by the Micronucleus Test.''
Mutation Research, 67: 383-384 (1979).
(3) Evans, H.J. ``Cytological Methods for Detecting Chemical
Mutagens.'' Chemical Mutagens: Principles and Methods for Their
Detection, Vol. 4. Ed. A. Hollaender (New York and London: Plenum Press,
1976) pp. 1-29.
[[Page 90]]
(4) Heddle, J.A., et al. ``The Induction of Micronuclei as a Measure
of Genotoxicity. A Report of the U.S. Environmental Protection Agency
Gene-Tox Program.'' Mutation Research, 123:61-118 (1983).
(5) Preston, J.R. et al. ``Mammalian In Vivo and In Vitro
Cytogenetics Assays: Report of the Gene-Tox Program.'' Mutation
Research, 87:143-188 (1981).
(6) Schmid, W. ``The micronucleus test for cytogenetic analysis'',
Chemical Mutagens, Principles and Methods for their Detection. Vol. 4
Hollaender A, (Ed. A ed. (New York and London: Plenum Press, (1976) pp.
31-53.
(7) Tice, R.E., and Al Pellom ``User's guide: Micronucleus assay
data management and analysis system'', NTIS Order no. PB-90-212-598AS.
Sec. 79.65 In vivo sister chromatid exchange assay.
(a) Purpose. The in vivo sister chromatid exchange (SCE) assay
detects the ability of a chemical to enhance the exchange of DNA between
two sister chromatids of a duplicating chromosome. The most commonly
used assays employ mammalian bone marrow cells or peripheral blood
lymphocytes, often from rodent species.
(b) Definitions. For the purposes of this section, the following
definitions apply:
C-metaphase means a state of arrested cell growth typically seen
after treatment with a spindle inhibitor, i.e., colchicine.
Sister chromatid exchange means a reciprocal interchange of the two
chromatid arms within a single chromosome. This exchange is visualized
during the metaphase portion of the cell cycle and presumably requires
the enzymatic incision, translocation and ligation of at least two DNA
helices.
(c) Test method--(1) Principle of the test method. (i) Groups of
rodents are exposed by the inhalation route for a minimum of 6 hours/day
over a period of not less than 28 days to three or more concentrations
of a test substance in air. Groups of animals are sacrificed at the end
of the exposure period and blood lymphocyte cell cultures are prepared
from study animals. Cell growth is suspended after a time and cells are
harvested, fixed and stained before scoring for SCEs. Researchers may
need to run a trial at the highest tolerated concentration of the test
atmosphere to optimize the sample collection time for second division
metaphase cells.
(ii) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions in Sec. 79.62.
(2) Description. (i) The method described here employs peripheral
blood lymphocytes (PBL) of laboratory rodents exposed to the test
atmosphere.
(ii) Within twenty-four hours of the last exposure, test animal
lymphocytes are obtained by heart puncture and duplicate cell cultures
are started for each animal. Cultures are grown in bromo-deoxyuridine
(BrdU), and then a spindle inhibitor (e.g., colchicine) is added to
arrest cell growth. Cells are harvested, fixed, and stained and their
chromosomes are scored for SCEs.
(3) Species and strain. The rat is the recommended test animal.
Other rodent species may be used in this assay, but use of that species
will be justified by the tester.
(4) Animal number and sex. At least five female and five male
animals per experimental and control group shall be used. The use of a
single sex or different number of animals shall be justified.
(5) Positive control group. A single concentration of a compound
known to produce SCEs in vivo is adequate as a positive control if it
shows a significant response at any one time point; additional
concentration levels may be used. To select an appropriate concentration
level, a pilot or trial study may be advisable. Initially, one
concentration of the test substance may be used, the maximum tolerated
dose or that producing some indication of toxicity as evidenced by
animal morbidity (including death) or target cell toxicity.
Intraperitoneal injection of 1,2-dimethyl-benz-anthracene or benzene are
examples of positive control exposures. A concentration of 50-80 percent
of an LD50 would also be a suitable guide.
(6) Inhalation exposure. (i) All data developed within this study
shall be in
[[Page 91]]
accordance with good laboratory practice provisions under Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(d) Test performance--(1) Treatment. At the conclusion of the
exposure period, all test animals are anaesthetized and heart punctures
are performed. Lymphocytes are isolated over a Ficoll gradient and
replicate cell cultures are started for each animal. After some 21
hours, the cells are treated with BrdU and returned to incubation. The
following day, a spindle inhibitor (e.g., colchicine) is added to arrest
cell growth in c-metaphase. Cells are harvested 4 hours later and
second-division metaphase cells are washed and fixed in methanol:acetic
acid, stained, and chromosome preparations are scored for SCEs.
(2) Staining method. Staining of slides to reveal SCEs can be
performed according to any of several protocols. However, the
fluorescence plus Giemsa method is recommended.
(3) Number of cells scored. (i) A minimum of 25 well-stained,
second-division metaphase cells shall be scored for each animal for each
cell type.
(ii) At least 100 consecutive metaphase cells shall be scored for
the number of first, second, and third division metaphases for each
animal for each cell type.
(iii) At least 1000 consecutive PBL's shall be scored for the number
of metaphase cells present.
(iv) The number of cells to be analyzed per animal shall be based
upon the number of animals used, the negative control frequency, the
pre-determined sensitivity and the power chosen for the test. Slides
shall be coded before microscopic analysis.
(e) Data and report--(1) Treatment of results. In addition to the
reporting requirements specified under Sec. Sec. 79.60 and 61, data
shall be presented in tabular form, providing scores for both the number
of SCE for each metaphase. Differences among animals within each group
shall be considered before making comparisons between treated and
control groups.
(2) Statistical evaluation. Data shall be evaluated by appropriate
statistical methods.
(3) Interpretation of results. (i) There are several criteria for
determining a positive result, one of which is a statistically
significant dose-related increase in the number of SCE. Another
criterion may be based upon detection of a reproducible and
statistically significant positive response for at least one of the test
concentrations.
(ii) A test substance which does not produce either a statistically
significant dose-related increase in the number of SCE or a
statistically significant and reproducible positive response at any one
of the test concentrations is considered not to induce rearrangements of
DNA segments in this system.
(iii) Both biological and statistical significance shall be
considered together in the evaluation.
(4) Test evaluation. (i) A positive result in the in vivo SCE assay
for either, or both, the lung or lymphocyte cultures indicates that
under the test conditions the test substance induces reciprocal
interchanges of DNA in duplicating chromosomes from lung or lymphocyte
cells of the test species.
(ii) Negative results indicate that under the test conditions the
test substance does not induce reciprocal interchanges in lung or
lymphocyte cells of the test species.
(5) Test report. In addition to the reporting recommendations as
specified under Sec. Sec. 79.60 and 79.61, the following specific
information shall be reported:
(i) Test concentrations used, rationale for concentration selection,
negative and positive controls;
(ii) Toxic response data by concentration;
(iii) Schedule of administration of test atmosphere, BrdU, and
spindle inhibitor;
(iv) Time of harvest after administration of BrdU;
(v) Identity of spindle inhibitor, its concentration and timing of
treatment;
(vi) Details of the protocol used for cell culture and slide
preparation;
(vii) Criteria for scoring SCE;
(viii) Replicative index, i.e., [percent 1st division + (2 x percent
2nd division) + (3 x percent 3rd division) metaphases]/100; and
[[Page 92]]
(ix) Mitotic activity, i.e., of metaphases/1000 cells.
(f) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.5915, In vivo Sister Chromatid Exchange Assay.
(2) Kato, H. ``Spontaneous Sister Chromatid Exchanges Detected by a
BudR-Labeling Method.'' Nature, 251:70-72 (1974).
(4) Kligerman, A. D., et al. ``Sister Chromatid Exchange Analysis in
Lung and Peripheral Blood Lymphocytes of Mice Exposed to Methyl
Isocyanate by Inhalation.'' Environmental Mutagenesis 9:29-36 (1987).
(5) Kligerman, A.D., et al., ``Cytogenetic Studies of Rodents
Exposed to Styrene by Inhalation'', IARC Monographs no. 127 ``Butadiene
and Styrene: Assesment of Health Hazards'' (Sorsa, et al., eds), pp 217-
224, 1993.
(6) Kligerman, A., et al., ``Cytogenetic Studies of Mice Exposed to
Styrene by Inhalation.'', Mutation Research, 280:35-43, 1992.
(7) Wolff, S., and P. Perry. ``Differential Giemsa Staining of
Sister Chromatids and the Study of Sister Chromatid Exchanges Without
Autoradiography.'' Chromosoma 48: 341-53 (1974).
Sec. 79.66 Neuropathology assessment.
(a) Purpose. (1) The histopathological and biochemical techniques in
this guideline are designed to develop data in animals on morphologic
changes in the nervous system associated with repeated inhalation
exposures to motor vehicle emissions. These tests are not intended to
provide a detailed evaluation of neurotoxicity. Neuropathological
evaluation should be complemented by other neurotoxicity studies, e.g.
behavioral and neurophysiological studies and/or general toxicity
testing, to more completely assess the neurotoxic potential of an
exposure.
(2) [Reserved]
(b) Definition. Neurotoxicity (NTX) or a neurotoxic effect is an
adverse change in the structure or function of the nervous system
following exposure to a chemical substance.
(c) Principle of the test method. (1) Laboratory rodents are exposed
to one of several concentration levels of a test atmosphere for at least
six hours daily over a period of 90 days. At the end of the exposure
period, the animals are anaesthetized, perfused in situ with fixative,
and tissues in the nervous system are examined grossly and prepared for
microscopic examination. Starting with the highest dosage level, tissues
are examined under the light microscope for morphologic changes, until a
no-observed-adverse-effect level is determined. In cases where light
microscopy has revealed neuropathology, the NOAEL may be confirmed by
electron microscopy.
(2) The tests described herein may be combined with any other
toxicity study, as long as none of the requirements of either are
violated by the combination. Specifically, this assay may be combined
with a subchronic toxicity study, pursuant to provisions in Sec. 79.62.
(d) Limit test. If a test at one dose level of the highest
concentration that can be achieved while maintaining a particle size
distribution with a mass median aerodynamic diameter (MMAD) of 4
micrometers ([micro]m) or less, using the procedures described in
paragraph (a) of this section, produces no observable toxic effects and
if toxicity would not be expected based upon data of structurally
related compounds, then a full study using three dose levels might not
be necessary. Expected human exposure though may indicate the need for a
higher dose level.
(e) Test procedures--(1) Animal selection--(i) Species and strain.
Testing shall be performed in the species being used in other NTX tests.
A standard strain of laboratory rat is recommended. The choice of
species shall take into consideration such factors as the comparative
metabolism of the chemical and species sensitivity to the toxic effects
of the test substance, as evidenced by the results of other studies, the
potential for combined studies, and the availability of other toxicity
data for the species.
(ii) Age. Animals shall be at least ten weeks of age at the start of
exposure.
[[Page 93]]
(iii) Sex. Both sexes shall be used unless it is demonstrated that
one sex is refractory to the effects of exposure.
(2) Number of Animals. A minimum of ten animals per group shall be
used. The tissues from each animal shall be examined separately.
(3) Control Groups. (i) A concurrent control group, exposed to
clean, filtered air only, is required.
(ii) The laboratory performing the testing shall provide positive
control data, e.g., results from repeated acrylamide exposure, as
evidence of the ability of their histology procedures to detect
neurotoxic endpoints. Positive control data shall be collected at the
time of the test study unless the laboratory can demonstrate the
adequacy of historical data for the planned study.
(iii) A satellite group of 10 female and 10 male test subjects shall
be treated with the highest concentration level for the duration of the
exposure and observed thereafter for reversibility, persistence, or
delayed occurrence of toxic effects during a post-treatment period of
not less than 28 days.
(4) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(5) Study conduct--(i) Observation of animals. All toxicological
(e.g., weight loss) and neurological signs (e.g., motor disturbance)
shall be recorded frequently enough to observe any abnormality, and not
less than weekly.
(ii) The following is a minimal list of measures that shall be
noted:
(A) Body weight;
(B) Subject's reactivity to general stimuli such as removal from the
cage or handling;
(C) Description, incidence, and severity of any convulsions,
tremors, or abnormal motor movements in the home cage;
(D) Descriptions and incidence of posture and gait abnormalities
observed in the home cage; and
(E) Description and incidence of any unusual or abnormal behaviors,
excessive or repetitive actions (stereotypies), emaciation, dehydration,
hypotonia or hypertonia, altered fur appearance, red or crusty deposits
around the eyes, nose, or mouth, and any other observations that may
facilitate interpretation of the data.
(iii) Sacrifice of animals--(A) General. The goal of the techniques
outlined for sacrifice of animals and preparation of tissues is
preservation of tissue morphology to simulate the living state of the
cell.
(B) Perfusion technique. Animals shall be perfused in situ by a
generally recognized technique. For fixation suitable for light or
electronic microscopy, saline solution followed by buffered 2.5 percent
glutaraldehyde or buffered 4.0 percent paraformaldehyde, is recommended.
While some minor modifications or variations in procedures are used in
different laboratories, a detailed and standard procedure for vascular
perfusion may be found in the text by Zeman and Innes (1963), Hayat
(1970), and Spencer and Schaumburg (1980) under paragraph (g) of this
section. A more sophisticated technique is described by Palay and Chan-
Palay (1974) under paragraph (g) of this section. In addition, the lungs
shall be instilled with fixative via the trachea during the fixation
process in order to preserve the lungs and achieve whole-body fixation.
(C) Removal of brain and cord. After perfusion, the bony structure
(cranium and vertebral column) shall be exposed. Animals shall then be
stored in fixative-filled bags at 4 [deg]C for 8-12 hours. The cranium
and vertebral column shall be removed carefully by trained technicians
without physical damage of the brain and cord. Detailed dissection
procedures may be found in the text by Palay and Chan-Palay (1974) under
paragraph (g) of this section. After removal, simple measurement of the
size (length and width) and weight of the whole brain (cerebrum,
cerebellum, pons-medulla) shall be made. Any abnormal coloration or
discoloration of the brain and cord shall also be noted and recorded.
(D) Sampling. Cross-sections of the following areas shall be
examined: The forebrain, the center of the cerebrum, the midbrain, the
cerebellum, and the medulla oblongata; the spinal cord at
[[Page 94]]
the cervical swelling (C3-C6), and proximal
sciatic nerve (mid-thigh and sciatic notch) or tibial nerve (at knee).
Other sites and tissue elements (e.g., gastrocnemius muscle) shall be
examined if deemed necessary. Any observable gross changes shall be
recorded.
(iv) Specimen storage. Tissue samples from both the central and
peripheral nervous system shall be further immersion fixed and stored in
appropriate fixative (e.g., 10 percent buffered formalin for light
microscopy; 2.5 percent buffered gluteraldehyde or 4.0 percent buffered
paraformaldehyde for electron microscopy) for future examination. The
volume of fixative versus the volume of tissues in a specimen jar shall
be no less than 25:1. All stored tissues shall be washed with buffer for
at least 2 hours prior to further tissue processing.
(v) Histopathology examination--(A) Fixation. Tissue specimens
stored in 10 percent buffered formalin may be used for this purpose. All
tissues must be immersion fixed in fixative for at least 48 hours prior
to further tissue processing.
(B) Dehydration. All tissue specimens shall be washed for at least 1
hour with water or buffer, prior to dehydration. (A longer washing time
is needed if the specimens have been stored in fixative for a prolonged
period of time.) Dehydration can be performed with increasing
concentration of graded ethanols up to absolute alcohol.
(C) Clearing and embedding. After dehydration, tissue specimens
shall be cleared with xylene and embedded in paraffin or paraplast.
Multiple tissue specimens (e.g. brain, cord, ganglia) may be embedded
together in one single block for sectioning. All tissue blocks shall be
labelled showing at least the experiment number, animal number, and
specimens embedded.
(D) Sectioning. Tissue sections, 5 to 6 microns in thickness, shall
be prepared from the tissue blocks and mounted on standard glass slides.
It is recommended that several additional sections be made from each
block at this time for possible future needs for special stainings. All
tissue blocks and slides shall be filed and stored in properly labeled
files or boxes.
(E) Histopathological techniques. The following general testing
sequence is proposed for gathering histopathological data:
(1) General staining. A general staining procedure shall be
performed on all tissue specimens in the highest treatment group.
Hematoxylin and eosin (H&E) shall be used for this purpose. The staining
shall be differentiated properly to achieve bluish nuclei with pinkish
background.
(2) Peripheral nerve teasing. Peripheral nerve fiber teasing shall
be used. Detailed staining methodology is available in standard
histotechnological manuals such as AFIP (1968), Ralis et al. (1973), and
Chang (1979) under paragraph (g) of this section. The nerve fiber
teasing technique is discussed in Spencer and Schaumberg (1980) under
paragraph (g) of this section. A section of normal tissue shall be
included in each staining to assure that adequate staining has occurred.
Any changes shall be noted and representative photographs shall be
taken. If a lesion(s) is observed, the special techniques shall be
repeated in the next lower treatment group until no further lesion is
detectable.
(F) Examination. All stained microscopic slides shall be examined
with a standard research microscope. Examples of cellular alterations
(e.g., neuronal vacuolation, degeneration, and necrosis) and tissue
changes (e.g., gliosis, leukocytic infiltration, and cystic formation)
shall be recorded and photographed.
(f) Data collection, reporting, and evaluation. In addition to
information meeting the requirements stated under 40 CFR 79.60 and
79.61, the following specific information shall be reported:
(1) Description of test system and test methods. (i) A description
of the general design of the experiment shall be provided. This shall
include a short justification explaining any decisions where
professional judgment is involved such as fixation technique and choice
of stains; and
(ii) Positive control data from the laboratory performing the test
that demonstrate the sensitivity of the procedures being used.
Historical data may be used if all essential aspects of
[[Page 95]]
the experimental protocol are the same.
(2) Results. All observations shall be recorded and arranged by test
groups. This data may be presented in the following recommended format:
(i) Description of signs and lesions for each animal. For each
animal, data must be submitted showing its identification (animal
number, treatment, dose, duration), neurologic signs, location(s) nature
of, frequency, and severity of lesion(s). A commonly-used scale such as
1 + , 2 + , 3 + , and 4 + for degree of severity ranging from very
slight to extensive may be used. Any diagnoses derived from neurologic
signs and lesions including naturally occurring diseases or conditions,
shall also be recorded;
(ii) Counts and incidence of lesions, by test group. Data shall be
tabulated to show:
(A) The number of animals used in each group, the number of animals
displaying specific neurologic signs, and the number of animals in which
any lesion was found; and
(B) The number of animals affected by each different type of lesion,
the average grade of each type of lesion, and the frequency of each
different type and/or location of lesion.
(iii) Evaluation of data. (A) An evaluation of the data based on
gross necropsy findings and microscopic pathology observations shall be
made and supplied. The evaluation shall include the relationship, if
any, between the animal's exposure to the test atmosphere and the
frequency and severity of any lesions observed; and
(B) The evaluation of dose-response, if existent, for various groups
shall be given, and a description of statistical method must be
presented. The evaluation of neuropathology data shall include, where
applicable, an assessment in conjunction with any other neurotoxicity
studies, electrophysiological, behavioral, or neurochemical, which may
be relevant to this study.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.6400, Neuropathology.
(2) AFIP Manual of Histologic Staining Methods. (New York: McGraw-
Hill (1968).
(3) Chang, L.W. A Color Atlas and Manual for Applied Histochemistry.
(Springfield, IL: Charles C. Thomas, 1979).
(4) Dunnick, J.K., et.al. Thirteen-week Toxicity Study of N-Hexane
in B6C3F1 Mice After Inhalation Exposure (1989) Toxicology, 57, 163-172.
(5) Hayat, M.A. ``Vol. 1. Biological applications,'' Principles and
techniques of electron microscopy. (New York: Van Nostrand Reinhold,
1970).
(6) Palay S.L., Chan-Palay, V. Cerebellar Cortex: Cytology and
Organization. (New York: Springer-Verlag, 1974).
(7) Ralis, H.M., Beesley, R.A., Ralis, Z.A. Techniques in
Neurohistology. (London: Butterworths, 1973).
(8) Sette, W. ``Pesticide Assessment Guidelines, Subdivision F,
Neurotoxicity Test Guidelines.'' Report No. 540/09-91-123 U.S.
Environmental Protection Agency 1991 (NTIS PB91-154617).
(9) Spencer, P.S., Schaumburg, H.H. (eds). Experimental and Clinical
Neurotoxicology. (Baltimore: Williams and Wilkins, 1980).
(10) Zeman, W., Innes, J.R.M. Craigie's Neuroanatomy of the Rat.
(New York: Academic, 1963).
[59 FR 33093, June 27, 1994, as amended at 63 FR 63793, Nov. 17, 1999]
Sec. 79.67 Glial fibrillary acidic protein assay.
(a) Purpose. Chemical-induced injury of the nervous system, i.e.,
the brain, is associated with astrocytic hypertrophy at the site of
damage (see O'Callaghan, 1988 in paragraph (e)(3) in this section).
Assays of glial fibrillary acidic protein (GFAP), the major intermediate
filament protein of astrocytes, can be used to document this response.
To date, a diverse variety of chemical insults known to be injurious to
the central nervous system have been shown to increase GFAP. Moreover,
increases in GFAP can be seen at concentrations below those necessary to
produce cytopathology as determined by routine Nissl stains (standard
neuropathology). Thus it appears that assays of GFAP represent a
sensitive
[[Page 96]]
approach for documenting the existence and location of chemical-induced
injury of the central nervous system. Additional functional,
histopathological, and biochemical tests are necessary to assess
completely the neurotoxic potential of any chemical. This biochemical
test is intended to be used in conjunction with neurohistopathological
studies.
(b) Principle of the test method. (1) This guideline describes the
conduct of a radioimmunoassay for measurement of the amount of GFAP in
the brain of vehicle emission-exposed and unexposed control animals. It
is based on modifications (O'Callaghan & Miller 1985 in paragraph
(e)(5), O'Callaghan 1987 in paragraph (e)(1) of this section) of the
dot-immunobinding procedure described by Jahn et al. (1984) in paragraph
(e)(2) of this section. Briefly, brain tissue samples from study animals
are assayed for total protein, diluted in dot-immunobinding buffer, and
applied to nitrocellulose sheets. The spotted sheets are then fixed,
blocked, washed and incubated in anti-GFAP antibody and [I\125\] Protein
A. Bound protein A is then quantified by gamma spectrometry. In lieu of
purified protein standards, standard curves are constructed from
dilution of a single control sample. By comparing the immunoreactivity
of individual samples (both control and exposed groups) with that of the
sample used to generate the standard curve, the relative
immunoreactivity of each sample is obtained. The immunoreactivity of the
control groups is normalized to 100 percent and all data are expressed
as a percentage of control. A variation on this radioimmunoassay
procedure has been proposed (O'Callaghan 1991 in paragraph (e)(4) of
this section) which uses a ``sandwich'' of GFAP, anti-GFAP, and a
chromophore in a microtiter plate format enzyme-link immunosorbent assay
(ELISA). The use of this variation shall be justified.
(2) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions of Sec. 79.62.
(c) Test procedure--(1) Animal selection--(i) Species and strain.
Test shall be performed on the species being used in concurrent testing
for neurotoxic or other health effect endpoints. This will generally be
a species of laboratory rat. The use of other rodent or non-rodent
species shall be justified.
(ii) Age. Based on other concurrent testing, young adult rats shall
be used. Study rodents shall not be older than ten weeks at the start of
exposures.
(iii) Number of animals. A minimum of ten animals per group shall be
used. The tissues from each animal shall be examined separately.
(iv) Sex. Both sexes shall be used unless it is demonstrated that
one sex is refractory to the effects.
(2) Materials. The materials necessary to perform this study are
[I\125\] Protein A (2-10 [micro]Ci/[micro]g), Anti-sera to GFAP,
nitrocellulose paper (0.1 or 0.2 [micro]m pore size), sample application
template (optional; e.g., ``Minifold II'', Schleicher & Schuell, Keene,
NH), plastic sheet incubation trays.
(3) Study conduct. (i) All data developed within this study shall be
in accordance with good laboratory practice provisions under Sec.
79.60.
(ii) Tissue Preparation. Animals are euthanized 24 hours after the
last exposure and the brain is excised from the skull. On a cold
dissecting platform, the following six regions are dissected freehand:
cerebellum; cerebral cortex; hippocampus; striatum; thalamus/
hypothalamus; and the rest of the brain. Each region is then weighed and
homogenized in 10 volumes of hot (70-90 [deg]C) 1 percent (w/v) sodium
dodecyl sulfate (SDS). Homogenization is best achieved through sonic
disruption. A motor driven pestle inserted into a tissue grinding vessel
is a suitable alternative. The homogenized samples can then be stored
frozen at -70 [deg]C for at least 4 years without loss of GFAP content.
(iii) Total Protein Assay. Aliquots of the tissue samples are
assayed for total protein using the method of Smith et al. (1985) in
paragraph (e)(7) of this section. This assay may be purchased in kit
form (e.g., Pierce Chemical Company, Rockford, IL).
(iv) Sample Preparation. Dilute tissue samples in sample buffer (120
mM KCl, 20 mM NaCl, 2 mM MgCl2), 5 mM Hepes, pH 7.4, 0.7
percent Triton X-100) to a final concentration of 0.25 mg total protein
per ml (5 [micro]g/20 [micro]l).
[[Page 97]]
(v) Preparation of Standard Curve. Dilute a single control sample in
sample buffer to give at least five standards, between 1 and 10 [micro]g
total protein per 20 [micro]l. The suggested values of total protein per
20 [micro]l sample buffer are 1.25, 2.50, 3.25, 5.0, 6.25, 7.5, 8.75,
and 10.0 [micro]g.
(vi) Preparation of Nitrocellulose Sheets. Nitrocellulose sheets of
0.1 or 0.2 micron pore size are rinsed by immersion in distilled water
for 5 minutes and then air dried.
(vii) Sample Application. Samples can be spotted onto the
nitrocellulose sheets free-hand or with the aid of a template. For free-
hand application, draw a grid of squares approximately 2 centimeters by
2 centimeters (cm) on the nitrocellulose sheets using a soft pencil.
Spot 5-10 [micro]l portions to the center of each square for a total
sample volume of 20 [micro]l. For template aided sample application a
washerless microliter capacity sample application manifold is used.
Position the nitrocellulose sheet in the sample application device as
recommended by the manufacturer and spot a 20 [micro]l sample in one
application. Do not wet the nitrocellulose or any support elements prior
to sample application. Do not apply vacuum during or after sample
application. After spotting samples (using either method), let the
sheets air dry. The sheets can be stored at room temperature for several
days after sample application.
(viii) Standard Incubation Conditions. These conditions have been
described by Jahn et al. (1984) in paragraph (e)(2) of this section. All
steps are carried out at room temperature on a flat shaking platform
(one complete excursion every 2-3 seconds). For best results, do not use
rocking or orbital shakers. Perform the following steps in enough
solution to cover the nitrocellulose sheets to a depth of 1 cm.
(A) Incubate 20 minutes in fixer (25 percent (v/v) isopropanol, 10
percent (v/v) acetic acid).
(B) Discard fixer, wash several times in deionized water to
eliminate the fixer, and then incubate for 5 minutes in Tris-buffered
saline (TBS): 200 mM NaCL, 60 mM Tris-HCl to pH 7.4.
(C) Discard TBS and incubate 1 hour in blocking solution (0.5
percent gelatin (w/v)) in TBS.
(D) Discard blocking solution and incubate for 2 hours in antibody
solution (anti-GFAP antiserum diluted to the desired dilution in
blocking solution containing 0.1 percent Triton X-100). Serum anti-
bovine GFAP, which cross reacts with GFAP from rodents and humans, can
be obtained commercially (e.g., Dako Corp.) and used at a dilution of
1:500.
(E) Discard antibody solution, and wash in 4 changes of TBS for 5
minutes each time. Then wash in TBS for 10 minutes.
(F) Discard TBS and incubate in blocking solution for 30 minutes.
(G) Discard blocking solution and incubate for 1 hour in Protein A
solution ([I\125\]-labeled Protein A diluted in blocking solution
containing 0.1 percent Triton X-100, sufficient to produce 2000 counts
per minute (cpm) per 10 [micro]l of Protein A solution).
(H) Remove Protein A solution (it may be reused once). Wash in 0.1
percent Triton X-100 in TBS (TBSTX) for 5 minutes, 4 times. Then wash in
TBSTX for 2-3 hours for 4 additional times. An overnight wash in a
larger volume can be used to replace the last 4 washes.
(I) Hang sheets to air-dry. Cut out squares or spots and count
radioactivity in a gamma counter.
(ix) Expression of data. Compare radioactivity counts for samples
obtained from control and treated animals with counts obtained from the
standard curve. By comparing the immunoreactivity (counts) of each
sample with that of the standard curve, the relative amount of GFAP in
each sample can be determined and expressed as a percent of control.
(d) Data Reporting and Evaluation--(1) Test Report. In addition to
information meeting the requirements stated under 40 CFR 79.60, the
following specific information shall be reported:
(i) Body weight and brain region weights at time of sacrifice for
each subject tested;
(ii) Indication of whether each subject survived to sacrifice or
time of death;
(iii) Data from control animals and blank samples; and
(iv) Statistical evaluation of results;
[[Page 98]]
(2) Evaluation of Results. (i) Results shall be evaluated in terms
of the extent of change in the amount of GFAP as a function of treatment
and dose. GFAP assays (of any brain region) from a minimum of 6 samples
typically will result in a standard error of the mean of 5 percent. In this case, a chemically-induced increase
in GFAP of 115 percent of control is likely to be statistically
significant.
(ii) The results of this assay shall be compared to and evaluated
with any relevant behavioral and histopathological data.
(e) References. For additional background information on this test
guideline the following references should be consulted.
(1) Brock, T.O and O'Callaghan, J.P. 1987. Quantitative changes in
the synaptic vesicle proteins, synapsin I and p38 and the astrocyte
specific protein, glial fibrillary acidic protein, are associated with
chemical-induced injury to the rat central nervous system, J. Neurosci.
7:931-942.
(2) Jahn, R., Schiebler, W. Greengard, P. 1984. A quantitative dot-
immunobinding assay for protein using nitrocellulose membrane filters.
Proc. Natl. Acad. Sci. U.S.A. 81:1684-1687.
(3) O'Callaghan, J.P. 1988. Neurotypic and gliotypic protein as
biochemical markers of neurotoxicity. Neurotoxicol. Teratol. 10:445-452.
(4) O'Callaghan, J.P. 1991. Quantification of glial fibrillary
acidic protein: comparison of slot-immunobinding assays with a novel
sandwich ELISA. Neurotoxicol. Teratol. 13:275-281.
(5) O'Callaghan, J.P. and Miller, D.B. 1985. Cerebellar hypoplasia
in the Gunn rat is associated with quantitative changes in neurotypic
and gliotypic proteins. J. Pharmacol. Exp. Ther. 234:522-532.
(6) Sette, W.F. ``Pesticide Assessment Guidelines, Subdivision `F',
Hazard Evaluation: Human and Domestic Animals, Addendum 10,
Neurotoxicity, Series 81, 82, and 83'' US-EPA, Office of Pesticide
Programs, EPA-540/09-91-123, March 1991.
(7) Smith, P.K., Krohn, R.I., Hermanson, G.T., Mallia, A.K.,
Gartner, F.H., Provenzano, M.D., Fujimoto, E.K., Goeke, N.M., Olson,
B.J., Klenk, D.C. 1985. Measurement of protein using bicinchoninic acid.
Annal. Biochem. 150:76-85.
Sec. 79.68 Salmonella typhimurium reverse mutation assay.
(a) Purpose. The Salmonella typhimurium histidine (his) reversion
system is a microbial assay which measures his- [rarr] his\ +
\ reversion induced by chemicals which cause base changes or frameshift
mutations in the genome of the microorganism Salmonella typhimurium.
(b) Definitions. For the purposes of this section, the following
definitions apply:
Base pair mutagen means an agent which causes a base change in DNA.
In a reversion assay, this change may occur at the site of the original
mutation or at a second site in the chromosome.
Frameshift mutagen is an agent which causes the addition or deletion
of single or multiple base pairs in the DNA molecule.
Salmonella typhimurium reverse mutation assay detects mutation in a
gene of a histidine-requiring strain to produce a histidine independent
strain of this organism.
(c) Reference substances. These may include, but need not be limited
to, sodium azide, 2-nitrofluorene, 9-aminoacridine, 2-aminoanthracene,
congo red, benzopurpurin 4B, trypan blue or direct blue 1.
(d) Test method--(1) Principle. Motor vehicle combustion emissions
from fuel or additive/base fuel mixtures are, first, filtered to trap
particulate matter and, then, passed through a sorbent resin to trap
semi-volatile gases. Bacteria are separately exposed to the extract from
both the filtered particulates and the resin-trapped organics. Assays
are conducted using both test mixtures with and without a metabolic
activation system and exposed cells are plated onto minimal medium.
After a suitable period of incubation, revertant colonies are counted in
test cultures and compared to the number of spontaneous revertants in
unexposed control cultures.
(2) Description. Several methods for performing the test have been
described. The procedures described here are for the direct plate
incorporation
[[Page 99]]
method and the azo-reduction method. Among those used are:
(i) Direct plate incorporation method;
(ii) Preincubation method;
(iii) Azo-reduction method;
(iv) Microsuspension method; and
(v) Spiral assay.
(3) Strain selection--(i) Designation. Five tester strains shall be
used in the assay. At the present time, TA1535, TA1537, TA98, and TA100
are designated as tester strains. The fifth strain will be chosen from
the pool of Salmonella strains commonly used to determine the degree to
which nitrated organic compounds, i.e., nitroarenes, contribute to the
overall mutagenic activity of a test substance. TA98/1,8-DNP6
or other suitable Rosenkranz nitro-reductase resistant strains will be
considered acceptable. The choice of the particular strain is left to
the discretion of the researcher. However, the researcher shall justify
the use of the selected bacterial tester strains.
(ii) Preparation and storage of bacterial tester strains. Recognized
methods of stock culture preparation and storage shall be used. The
requirement of histidine for growth shall be demonstrated for each
strain. Other phenotypic characteristics shall be checked using such
methods as crystal violet sensitivity and resistance to ampicillin.
Spontaneous reversion frequency shall be in the range expected as
reported in the literature and as established in the laboratory by
historical control values.
(iii) Bacterial growth. Fresh cultures of bacteria shall be grown up
to the late exponential or early stationary phase of growth
(approximately 108-109 cells per ml).
(4) Exogenous metabolic activation. Bacteria shall be exposed to the
test substance both in the presence and absence of an appropriate
exogenous metabolic activation system. For the direct plate
incorporation method, the most commonly used system is a cofactor-
supplemented postmitochondrial fraction prepared from the livers of
rodents treated with enzyme-inducing agents, such as Aroclor 1254. For
the azo-reduction method, a cofactor- supplemented postmitochondrial
fraction (S-9) prepared from the livers of untreated hamsters is
preferred. For this method, the cofactor supplement shall contain flavin
mononucleotide, exogenous glucose 6-phosphate dehydrogenase, NADH and
excess of glucose-6-phosphate.
(5) Control groups--(i) Concurrent controls. Concurrent positive and
negative (untreated) controls shall be included in each experiment.
Positive controls shall ensure both strain responsiveness and efficacy
of the metabolic activation system.
(ii) Strain specific positive controls shall be included in the
assay. Examples of strain specific positive controls are as follows:
(A) Strain TA1535, TA100: sodium azide;
(B) TA98: 2-nitrofluorene (without activation), 2-anthramine (with
activation);
(C) TA1537: 9-aminoacridine; and
(D) TA98/1,8-DNP6: benzo(a)pyrene (with activation).
The papers by Claxton et al., 1991 and 1992 in paragraph (g) in this
section will provide helpful information for the selection of positive
controls.
(iii) Positive controls to ensure the efficacy of the activation
system. The positive control reference substances for tests including a
metabolic activation system shall be selected on the basis of the type
of activation system used in the test. 2-Aminoanthracene is an example
of a positive control compound in plate-incorporation tests using
postmitochondrial fractions from the livers of rodents treated with
enzyme-inducing agents such as Aroclor-1254. Congo red is an example of
a positive control compound in the azo-reduction method. Other positive
control reference substances may be used.
(iv) Class-specific positive controls. The azo-reduction method
shall include positive controls from the same class of compounds as the
test agent wherever possible.
(6) Sampling the test atmosphere. (i) Extracts of test emissions are
collected on Teflon [supreg]-coated glass fiber filters using an exhaust
dilution setup. The particulates are extracted with dichloromethane
(DCM) using Soxhlet extraction techniques. Extracts in DCM can be stored
at dry ice temperatures until use.
[[Page 100]]
(ii) Gaseous hydrocarbons passing through the filter are trapped by
a porous, polymer resin, like XAD-2/styrene-divinylbenzene, or an
equivalent product. Methylene chloride is used to extract the resin and
the sample is evaporated to dryness before storage or use.
(iii) Samples taken from this material are then used to expose the
cells in this assay. Final concentration of extracts in solvent/vehicle,
or after solvent exchange, shall not interfere with cell viability or
growth rate. The paper by Stump (1982) in paragraph (g) of this section
is useful for preparing extracts of particulate and semi-volatile
organic compounds from diesel and gasoline exhaust stream.
(iv) Exposure concentrations. (A) The test should initially be
performed over a broad range of concentrations. Among the criteria to be
taken into consideration for determining the upper limits of test
substance concentration are cytotoxicity and solubility. Cytotoxicity of
the test chemical may be altered in the presence of metabolic activation
systems. Toxicity may be evidenced by a reduction in the number of
spontaneous revertants, a clearing of the background lawn or by the
degree of survival of treated cultures. Relatively insoluble samples
shall be tested up to the limits of solubility. The upper test chemical
concentration shall be determined on a case by case basis.
(B) Generally, a maximum of 5 mg/plate for pure substances is
considered acceptable. At least 5 different concentrations of test
substance shall be used with adequate intervals between test points.
(C) When appropriate, a single positive response shall be confirmed
by testing over a narrow range of concentrations.
(e) Test performance. All data developed within this study shall be
in accordance with good laboratory practice provisions under Sec.
79.60.
(1) Direct plate incorporation method. When testing with metabolic
activation, test solution, bacteria, and 0.5 ml of activation mixture
containing an adequate amount of postmitochondrial fraction shall be
added to the liquid overlay agar and mixed. This mixture is poured over
the surface of a selective agar plate. Overlay agar shall be allowed to
solidify before incubation. At the end of the incubation period,
revertant colonies per plate shall be counted. When testing without
metabolic activation, the test sample and 0.1 ml of a fresh bacterial
culture shall be added to 2.0 ml of overlay agar.
(2) Azo-reduction method. When testing with metabolic activation,
0.5 ml of activation mixture containing 150 [micro]l of
postmitochondrial fraction and 0.1 ml of bacterial culture shall be
added to a test tube kept on ice. 0.1 ml of test solution shall be
added, and the tubes shall be incubated with shaking at 30 [deg]C for 30
minutes. At the end of the incubation period, 2.0 ml of agar shall be
added to each tube, the contents mixed and poured over the surface of a
selective agar plate. Overlay agar shall be allowed to solidify before
incubation. At the end of the incubation period, revertant colonies per
plate shall be counted. For tests without metabolic activation, 0.5 ml
of buffer shall be used in place of the 0.5 ml of activation mixture.
All other procedures shall be the same as those used for the test with
metabolic activation.
(3) Other methods/modifications may also be appropriate.
(4) Media. An appropriate selective medium with an adequate overlay
agar shall be used.
(5) Incubation conditions. All plates within a given experiment
shall be incubated for the same time period. This incubation period
shall be for 48-72 hours at 37 [deg]C.
(6) Number of cultures. All plating shall be done at least in
triplicate.
(f) Data and report--(1) Treatment of results. Data shall be
presented as number of revertant colonies per plate, revertants per
kilogram (or liter) of fuel, and as revertants per kilometer (or mile,
or brake-horsepower/hour, as appropriate) for each replicate and dose.
These same measures shall be recorded on both the negative and positive
control plates. The mean number of revertant colonies per plate,
revertants per kilogram (or liter) of fuel, and revertants per kilometer
(or mile, or brake-horsepower/hour), as well as individual plate counts
and standard deviations shall be presented
[[Page 101]]
for the test substance, positive control, and negative control plates.
(2) Statistical evaluation. Data shall be evaluated by appropriate
statistical methods. Those methods shall include, at a minimum, means
and standard deviations of the reversion data.
(3) Interpretation of results. (i) There are several criteria for
determining a positive result, one of which is a statistically
significant dose-related increase in the number of revertants. Another
criterion may be based upon detection of a reproducible and
statistically significant positive response for at least one of the test
substance concentrations.
(ii) A test substance which does not produce either a statistically
significant dose-related increase in the number of revertants or a
statistically significant and reproducible positive response at any one
of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance shall be
considered together in the evaluation.
(4) Test evaluation. (i) Positive results from the Salmonella
typhimurium reverse mutation assay indicate that, under the test
conditions, the test substance induces point mutations by base changes
or frameshifts in the genome of this organism.
(ii) Negative results indicate that under the test conditions the
test substance is not mutagenic in Salmonella typhimurium.
(5) Test report. In addition to the reporting recommendations as
specified under 40 CFR 79.60, the following specific information shall
be reported:
(i) Sampling method(s) used and manner in which cells are exposed to
sample solution;
(ii) Bacterial strains used;
(iii) Metabolic activation system used (source, amount and
cofactor); details of preparation of postmitochondrial fraction;
(iv) Concentration levels and rationale for selection of
concentration range;
(v) Description of positive and negative controls, and
concentrations used, if appropriate;
(vi) Individual plate counts, mean number of revertant colonies per
plate, number of revertants per kilometer (or mile, or brake-horsepower/
hour), and standard deviation; and
(vii) Dose-response relationship, if applicable.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.5265, The Salmonella typhimurium reverse mutation
asay.
(2) Ames, B.N., McCann, J., Yamasaki, E. ``Methods for detecting
carcinogens and mutagens with the Salmonella/mammalian microsome
mutagenicity test,'' Mutation Research 31:347-364 (1975).
(3) Huisingh, J.L., et al.,``Mutagenic and Carcinogenic Potency of
Extracts of Diesel and Related Environmental Emissions: Study Design,
Sample Generation, Collection, and Preparation''. In: Health Effects of
Diesel Engine Emissions, Vol. II, W.E. Pepelko, R., M., Danner and N. A.
Clarke (Eds.), US EPA, Cincinnati, EPA-600/9-80-057b, pp. 788-800
(1980).
(4) [Reserved]
(5) Claxton, L.D., Allen, J., Auletta, A., Mortelmans, K., Nestmann,
E., Zeiger, E. ``Guide for the Salmonella typhimurium/mammalian
microsome tests for bacterial mutagenicity'' Mutation Research
189(2):83-91 (1987).
(6) Claxton, L., Houk, V.S., Allison, J.C., Creason, J.,
``Evaluating the relationship of metabolic activation system
concentrations and chemical dose concentrations for the Salmonella
Spiral and Plate Assays'' Mutation Research 253:127-136 (1991).
(7) Claxton, L., Houk, V.S., Monteith, L.G., Myers, L.E., Hughes,
T.J., ``Assessing the use of known mutagens to calibrate the Salmonella
typhimurium mutagenicity assay: I. Without exogenous activation.''
Mutation Research 253:137-147 (1991).
(8) Claxton, L., Houk, V.S., Warner, J.R., Myers, L.E., Hughes,
T.J., ``Assessing the use of known mutagens to calibrate the Salmonella
typhimurium mutagenicity assay: II. With exogenous activation.''
Mutation Research 253:149-159 (1991).
(9) Claxton, L., Creason, J., Lares, B., Augurell, E., Bagley, S.,
Bryant, D.W., Courtois, Y.A., Douglas, G., Clare, C.B., Goto, S.,
Quillardet, P., Jagannath,
[[Page 102]]
D.R., Mohn, G., Neilsen, P.A., Ohnishi, Y., Ong, T., Pederson, T.C.,
Shimizu, H., Nylund, L., Tokiwa, H., Vink, I.G.R., Wang, Y., Warshawsky,
D., ``Results of the IPCS Collaborative Study on Complex Mixtures''
Mutation Research 276:23-32 (1992).
(10) Claxton, L., Douglas, G., Krewski, D., Lewtas, J., Matsushita,
H., Rosenkranz, H., ``Overview, conclusions, and recommendations of the
IPCS Collaborative Study on Complex Mixtures'' Mutation Research 276:61-
80 (1992).
(11) Houk, V.S., Schalkowsky, S., and Claxton, L.D., ``Development
and Validation of the Spiral Salmonella Assay: An Automated Approach to
Bacterial Mutagenicity Testing'' Mutation Research 223:49-64 (1989).
(12) Jones, E., Richold, M., May, J.H., and Saje, A. ``The
Assessment of the Mutagenic Potential of Vehicle Engine Exhaust in the
Ames Salmonella Assay Using a Direct Exposure Method'' Mutation Research
97:35-40 (1985).
(13) Maron, D., and Ames, B. N., Revised methods for the Salmonella
mutagenicity test, Mutation Research, 113:173-212 (1983).
(14) Prival, M.J., and Mitchell, V.D. ``Analysis of a method for
testing azo dyes for mutagenic activity in Salmonella typhimurium in the
presence of flavin mononucleotide and hamster liver S-9,'' Mutation
Research 97:103-116 (1982).
(15) Rosenkranz, H.S., et.al. ``Nitropyrenes: Isolation,
identification, and reduction of mutagenic impurities in carbon black
and toners'' Science 209:1039-43 (1980).
(16) Stump, F., Snow, R., et.al., ``Trapping gaseous hydrocarbons
for mutagenic testing'' SAE Technical Paper Series, No. 820776 (1982).
(17) Vogel, H.J., Bonner, D.M. ``Acetylornithinase of E. coli:
partial purification and some properties,'' Journal of Biological
Chemistry. 218:97-106 (1956).
[59 FR 33093, June 27, 1994, as amended at 61 FR 36513, July 11, 1996]
PART 80_REGULATION OF FUELS AND FUEL ADDITIVES--Table of Contents
Subpart A_General Provisions
Sec.
80.1 Scope.
80.2 Definitions.
80.3 Acronyms and abbreviations.
80.4 Right of entry; tests and inspections.
80.5 Penalties.
80.7 Requests for information.
80.8 Sampling methods for gasoline, diesel fuel, fuel additives, and
renewable fuels.
80.9 Rounding.
80.10 Addresses.
80.11 Confidentiality of information.
80.12 Incorporation by reference.
Subpart B [Reserved]
Subpart C_Oxygenated Gasoline
80.35 Labeling of retail gasoline pumps; oxygenated gasoline.
80.36-80.39 [Reserved]
Subpart D [Reserved]
Subpart E_Biogas-Derived Renewable Fuel
80.100 Scope and application.
80.105 Biogas producers.
80.110 RNG producers, RNG importers, and biogas closed distribution
system RIN generators.
80.115 RNG RIN separators.
80.120 Parties that use biogas as a biointermediate or RNG as a
feedstock or as process heat or energy.
80.125 RINs for RNG.
80.130 RINs for renewable CNG/LNG from a biogas closed distribution
system.
80.135 Registration.
80.140 Reporting.
80.145 Recordkeeping.
80.150 Product transfer documents.
80.155 Sampling, testing, and measurement.
80.160 RNG importers, foreign biogas producers, and foreign RNG
producers.
80.165 Attest engagements.
80.170 Quality assurance plan.
80.175 Prohibited acts and liability provisions.
80.180 Affirmative defense provisions.
80.185 Potentially invalid RINs.
Subparts F-L [Reserved]
Subpart M_Renewable Fuel Standard
80.1400 Applicability.
80.1401 Definitions.
80.1402 Availability of information; confidentiality of information.
[[Page 103]]
80.1403 Which fuels are not subject to the 20% GHG thresholds?
80.1404 [Reserved]
80.1405 What are the Renewable Fuel Standards?
80.1406 Obligated party responsibilities.
80.1407 How are the Renewable Volume Obligations calculated?
80.1408 What are the requirements for parties that own and redesignate
certified NTDF as MVNRLM diesel fuel?
80.1409-80.1414 [Reserved]
80.1415 How are equivalence values assigned to renewable fuel?
80.1416 Petition process for evaluation of new renewable fuels pathways.
80.1417-80.1424 [Reserved]
80.1425 Renewable Identification Numbers (RINs).
80.1426 How are RINs generated and assigned to batches of renewable
fuel?
80.1427 How are RINs used to demonstrate compliance?
80.1428 General requirements for RIN distribution.
80.1429 Requirements for separating RINs from volumes of renewable fuel
or RNG.
80.1430 Requirements for exporters of renewable fuels.
80.1431 Treatment of invalid RINs.
80.1432 Reported spillage or disposal of renewable fuel.
80.1433 [Reserved]
80.1434 RIN retirement.
80.1435 How are RIN holdings and RIN holding thresholds calculated?
80.1436-80.1439 [Reserved]
80.1440 What are the provisions for blenders who handle and blend less
than 250,000 gallons of renewable fuel per year or who handle
renewable fuel blended for fuels under a national security
exemption?
80.1441 Small refinery exemption.
80.1442 What are the provisions for small refiners under the RFS
program?
80.1443 What are the opt-in provisions for noncontiguous states and
territories?
80.1444 Alternative RIN retirement schedule for small refineries.
80.1445-80.1448 [Reserved]
80.1449 What are the Production Outlook Report requirements?
80.1450 What are the registration requirements under the RFS program?
80.1451 What are the reporting requirements under the RFS program?
80.1452 What are the requirements related to the EPA Moderated
Transaction System (EMTS)?
80.1453 What are the product transfer document (PTD) requirements for
the RFS program?
80.1454 What are the recordkeeping requirements under the RFS program?
80.1455 [Reserved]
80.1456 What are the provisions for cellulosic biofuel waiver credits?
80.1457 Petition process for aggregate compliance approach for foreign
countries.
80.1458 Storage of renewable fuel, RNG, or biointermediate prior to
registration.
80.1459 [Reserved]
80.1460 What acts are prohibited under the RFS program?
80.1461 Who is liable for violations under the RFS program?
80.1462 [Reserved]
80.1463 What penalties apply under the RFS program?
80.1464 What are the attest engagement requirements under the RFS
program?
80.1465 [Reserved]
80.1466 What are the additional requirements under this subpart for
foreign renewable fuel producers and importers of renewable
fuels?
80.1467 What are the additional requirements under this subpart for a
foreign RIN owner?
80.1468 [Reserved]
80.1469 Requirements for Quality Assurance Plans.
80.1470 RIN replacement mechanisms for Option A independent third party
auditors.
80.1471 Requirements for QAP auditors.
80.1472 Requirements for quality assurance audits.
80.1473 Affirmative defenses.
80.1474 Replacement requirements for invalidly generated RINs.
80.1475 What are the additional attest engagement requirements for
parties that redesignate certified NTDF as MVNRLM diesel fuel?
80.1476 Requirements for biointermediate producers.
80.1477 Requirements for QAPs for biointermediate producers.
80.1478 Requirements for foreign biointermediate producers and
importers.
80.1479 Alternative recordkeeping requirements for separated yard waste,
separated food waste, separated MSW, and biogenic waste oils/
fats/greases.
Subparts N-O [Reserved]
Appendixes A-G to Part 80 [Reserved]
Authority: 42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).
Source: 38 FR 1255, Jan. 10, 1973, unless otherwise noted.
Subpart A_General Provisions
Sec. 80.1 Scope.
(a) This part prescribes regulations for the renewable fuel program
under the Clean Air Act section 211(o) (42 U.S.C. 7545(o)).
[[Page 104]]
(b) This part also prescribes regulations for the labeling of fuel
dispensing systems for oxygenated gasoline at retail under the Clean Air
Act section 211(m)(4) (42 U.S.C. 7545(m)(4)).
(c) Nothing in this part is intended to preempt the ability of state
or local governments to control or prohibit any fuel or fuel additive
for use in motor vehicles and motor vehicle engines which is not
explicitly regulated by this part.
[85 FR 78465, Dec. 4, 2020]
Sec. 80.2 Definitions.
The definitions of this section apply in this part unless otherwise
specified. Note that many terms defined here are common terms that have
specific meanings under this part.
Actual peak capacity means 105% of the maximum annual volume of
renewable fuels produced from a specific renewable fuel production
facility on a calendar year basis.
(1) For facilities that commenced construction prior to December 19,
2007, the actual peak capacity is based on the last five calendar years
prior to 2008, unless no such production exists, in which case actual
peak capacity is based on any calendar year after startup during the
first three years of operation.
(2) For facilities that commenced construction after December 19,
2007 and before January 1, 2010, that are fired with natural gas,
biomass, or a combination thereof, the actual peak capacity is based on
any calendar year after startup during the first three years of
operation.
(3) For all other facilities not included above, the actual peak
capacity is based on the last five calendar years prior to the year in
which the owner or operator registers the facility under the provisions
of Sec. 80.1450, unless no such production exists, in which case actual
peak capacity is based on any calendar year after startup during the
first three years of operation.
Adjusted cellulosic content means the percent of organic material
that is cellulose, hemicellulose, and lignin.
Advanced biofuel means renewable fuel, other than ethanol derived
from cornstarch, that has lifecycle greenhouse gas emissions that are at
least 50 percent less than baseline lifecycle greenhouse gas emissions.
Agricultural digester means an anaerobic digester that processes
only animal manure, crop residues, or separated yard waste with an
adjusted cellulosic content of at least 75%. Each and every material
processed in an agricultural digester must have an adjusted cellulosic
content of at least 75%.
Algae grown photosynthetically are algae that are grown such that
their energy and carbon are predominantly derived from photosynthesis.
Annual cover crop means an annual crop, planted as a rotation
between primary planted crops, or between trees and vines in orchards
and vineyards, typically to protect soil from erosion and to improve the
soil between periods of regular crops. An annual cover crop has no
existing market to which it can be sold except for its use as feedstock
for the production of renewable fuel.
Approved pathway means a pathway listed in table 1 to Sec. 80.1426
or in a petition approved under Sec. 80.1416 that is eligible to
generate RINs of a particular D code.
Areas at risk of wildfire are those areas in the ``wildland-urban
interface'', where humans and their development meet or intermix with
wildland fuel. Note that, for guidance, the SILVIS laboratory at the
University of Wisconsin maintains a website that provides a detailed map
of areas meeting this criteria at: www.silvis.forest.wisc.edu/projects/
US_WUI_2000.asp. The SILVIS laboratory is located at 1630 Linden Drive,
Madison, Wisconsin 53706 and can be contacted at (608) 263-4349.
A-RIN means a RIN verified during the interim period by a registered
independent third-party auditor using a QAP that has been approved under
Sec. 80.1469(a) following the audit process specified in Sec. 80.1472.
Assigned RIN means a RIN assigned to a volume of renewable fuel or
RNG pursuant to Sec. 80.1426(e) or Sec. 80.125(c), respectively, with
a K code of 1.
Audited facility means any facility audited under an approved
quality assurance plan under this part.
[[Page 105]]
Audited party means a party that pays for or receives services from
an independent third party under this part.
Baseline lifecycle greenhouse gas emissions means the average
lifecycle greenhouse gas emissions for gasoline or diesel (whichever is
being replaced by the renewable fuel) sold or distributed as
transportation fuel in 2005.
Baseline volume means the permitted capacity or, if permitted
capacity cannot be determined, the actual peak capacity or nameplate
capacity as applicable pursuant to Sec. 80.1450(b)(1)(v)(A) through
(C), of a specific renewable fuel production facility on a calendar year
basis.
Batch pathway means each combination of approved pathway,
equivalence value as determined under Sec. 80.1415, and verification
status for which a facility is registered.
Biocrude means a liquid biointermediate that meets all the following
requirements:
(1) It is produced at a biointermediate production facility using
one or more of the following processes:
(i) A process identified in row M under table 1 to Sec. 80.1426.
(ii) A process identified in a pathway listed in a petition approved
under Sec. 80.1416 for the production of renewable fuel produced from
biocrude.
(2) It is to be used to produce renewable fuel at a refinery as
defined in 40 CFR 1090.80.
Biodiesel means a mono-alkyl ester that meets ASTM D6751
(incorporated by reference, see Sec. 80.12).
Biodiesel distillation bottoms means the heavier product from
distillation at a biodiesel production facility that does not meet the
definition of biodiesel.
Biogas means a mixture of biomethane, inert gases, and impurities
that meets all the following requirements:
(1) It is produced through the anaerobic digestion of renewable
biomass under an approved pathway.
(2) Non-renewable components have not been added.
(3) It requires removal of additional components to be suitable for
its designated use (e.g., as a biointermediate, to produce RNG, or to
produce biogas-derived renewable fuel).
Biogas closed distribution system means the infrastructure contained
between when biogas is produced and when biogas or treated biogas is
used to produce biogas-derived renewable fuel within a discrete location
or series of locations that does not include placement of biogas,
treated biogas, or RNG on a natural gas commercial pipeline system.
Biogas closed distribution system RIN generator means any party that
generates RINs for renewable CNG/LNG in a biogas closed distribution
system.
Biogas-derived renewable fuel means renewable CNG/LNG or any other
renewable fuel that is produced from biogas or RNG, including from
biogas used as a biointermediate.
Biogas producer means any person who owns, leases, operates,
controls, or supervises a biogas production facility.
Biogas production facility means any facility where biogas is
produced from renewable biomass under an approved pathway.
Biogas used as a biointermediate means biogas or treated biogas that
a renewable fuel producer uses to produce renewable fuel other than
renewable CNG/LNG at a separate facility from where the biogas is
produced.
Biointermediate means any feedstock material that is intended for
use to produce renewable fuel and meets all the following requirements:
(1) It is produced from renewable biomass.
(2) It has not previously had RINs generated for it.
(3) It is produced at a facility registered with EPA that is
different than the facility at which it is used as feedstock material to
produce renewable fuel.
(4) It is produced from the feedstock material identified in an
approved pathway, will be used to produce the renewable fuel listed in
that approved pathway, and is produced and processed in accordance with
the process(es) listed in that approved pathway.
(5) Is one of the following types of biointermediate:
(i) Biocrude.
(ii) Biodiesel distillate bottoms.
(iii) Biomass-based sugars.
(iv) Digestate.
(v) Free fatty acid (FFA) feedstock.
[[Page 106]]
(vi) Glycerin.
(vii) Soapstock.
(viii) Undenatured ethanol.
(ix) Biogas used to make a renewable fuel other than renewable CNG/
LNG.
(6) It is not a feedstock material identified in an approved pathway
that is used to produce the renewable fuel specified in that approved
pathway.
Biointermediate import facility means any facility as defined in 40
CFR 1090.80 where a biointermediate is imported from outside the covered
location into the covered location.
Biointermediate importer means any person who owns, leases,
operates, controls, or supervises a biointermediate import facility.
Biointermediate producer means any person who owns, leases,
operates, controls, or supervises a biointermediate production facility.
Biointermediate production facility means all of the activities and
equipment associated with the production of a biointermediate starting
from the point of delivery of feedstock material to the point of final
storage of the end biointermediate product, which are located on one
property, and are under the control of the same person (or persons under
common control).
Biomass-based diesel means a renewable fuel that has lifecycle
greenhouse gas emissions that are at least 50 percent less than baseline
lifecycle greenhouse gas emissions and meets all of the requirements of
paragraph (1) of this definition:
(1)(i) Is a transportation fuel, transportation fuel additive,
heating oil, or jet fuel.
(ii) Meets the definition of either biodiesel or non-ester renewable
diesel.
(iii) Is registered as a motor vehicle fuel or fuel additive under
40 CFR part 79, if the fuel or fuel additive is intended for use in a
motor vehicle.
(2) Renewable fuel produced from renewable biomass that is co-
processed with petroleum is not biomass-based diesel.
Biomass-based sugars means sugars (e.g., dextrose, sucrose, etc.)
extracted from renewable biomass under an approved pathway, other than
through a form change specified in Sec. 80.1460(k)(2).
Biomethane means methane produced from renewable biomass.
B-RIN means a RIN verified during the interim period by a registered
independent third-party auditor using a QAP that has been approved under
Sec. 80.1469(b) following the audit process specified in Sec. 80.1472.
Business day has the meaning given in 40 CFR 1090.80.
Canola/Rapeseed oil means either of the following:
(1) Canola oil is oil from the plants Brassica napus, Brassica rapa,
Brassica juncea, Sinapis alba, or Sinapis arvensis, and which typically
contains less than 2 percent erucic acid in the component fatty acids
obtained.
(2) Rapeseed oil is the oil obtained from the plants Brassica napus,
Brassica rapa, or Brassica juncea.
Carrier means any distributor who transports or stores or causes the
transportation or storage of gasoline or diesel fuel without taking
title to or otherwise having any ownership of the gasoline or diesel
fuel, and without altering either the quality or quantity of the
gasoline or diesel fuel.
Category 3 (C3) marine vessels, for the purposes of this part 80,
are vessels that are propelled by engines meeting the definition of
``Category 3'' in 40 CFR 1042.901.
CBOB means gasoline blendstock that could become conventional
gasoline solely upon the addition of oxygenate.
Cellulosic biofuel means renewable fuel derived from any cellulose,
hemi-cellulose, or lignin that has lifecycle greenhouse gas emissions
that are at least 60 percent less than the baseline lifecycle greenhouse
gas emissions.
Cellulosic biogas feedstock means an individual feedstock used to
produce biogas that contains at least 75% average adjusted cellulosic
content and whose batch pathway has been assigned a D code of 3 or 7.
Cellulosic diesel is any renewable fuel which meets both the
definitions of cellulosic biofuel and biomass-based diesel. Cellulosic
diesel includes heating oil and jet fuel produced from cellulosic
feedstocks.
Certified non-transportation 15 ppm distillate fuel or certified
NTDF means distillate fuel that meets all the following:
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(1) The fuel has been certified under 40 CFR 1090.1000 as meeting
the ULSD standards in 40 CFR 1090.305.
(2) The fuel has been designated under 40 CFR 1090.1015 as certified
NTDF.
(3) The fuel has also been designated under 40 CFR 1090.1015 as 15
ppm heating oil, 15 ppm ECA marine fuel, or other non-transportation
fuel (e.g., jet fuel, kerosene, or distillate global marine fuel).
(4) The fuel has not been designated under 40 CFR 1090.1015 as ULSD
or 15 ppm MVNRLM diesel fuel.
(5) The PTD for the fuel meets the requirements in Sec. 80.1453(e).
Combined heat and power (CHP), also known as cogeneration, refers to
industrial processes in which waste heat from the production of
electricity is used for process energy in a biointermediate or renewable
fuel production facility.
Continuous measurement means the automated measurement of specified
parameters of biogas, treated biogas, or natural gas as follows:
(1) For in-line GC meters, automated measurement must occur and be
recorded no less frequent than once every 15 minutes.
(2) For flow meters, automated measurement must occur no less
frequent than once every 6 seconds, and weighted totals of such
measurement must be recorded at no more than 1 minute intervals.
(3) For all other meters, automated measurement and recording must
occur at a frequency specified at registration.
Contractual affiliate means one of the following:
(1) Two parties are contractual affiliates if they have an explicit
or implicit agreement in place for one to purchase or hold RINs on
behalf of the other or to deliver RINs to the other. This other party
may or may not be registered under the RFS program.
(2) Two parties are contractual affiliates if one RIN-owning party
purchases or holds RINs on behalf of the other. This other party may or
may not be registered under the RFS program.
Control area means a geographic area in which only oxygenated
gasoline under the oxygenated gasoline program may be sold or dispensed,
with boundaries determined by Clean Air Act section 211(m) (42 U.S.C.
7545(m)).
Control period means the period during which oxygenated gasoline
must be sold or dispensed in any control area, pursuant to Clean Air Act
section 211(m)(2) (42 U.S.C. 7545(m)(2)).
Conventional gasoline (CG) means any gasoline that has been
certified under 40 CFR 1090.1000(b) and is not RFG.
Co-processed means that renewable biomass or a biointermediate was
simultaneously processed with fossil fuels or other non-renewable
feedstock in the same unit or units to produce a fuel that is partially
derived from renewable biomass or a biointermediate.
Co-processed cellulosic diesel is any renewable fuel that meets the
definition of cellulosic biofuel and meets all the requirements of
paragraph (1) of this definition:
(1)(i) Is a transportation fuel, transportation fuel additive,
heating oil, or jet fuel.
(ii) Meets the definition of either biodiesel or non-ester renewable
diesel.
(iii) Is registered as a motor vehicle fuel or fuel additive under
40 CFR part 79, if the fuel or fuel additive is intended for use in a
motor vehicle.
(2) Co-processed cellulosic diesel includes all the following:
(i) Heating oil and jet fuel produced from cellulosic feedstocks.
(ii) Cellulosic biofuel produced from cellulosic feedstocks co-
processed with petroleum.
Corn oil extraction means the recovery of corn oil from the thin
stillage and/or the distillers grains and solubles produced by a dry
mill corn ethanol plant, most often by mechanical separation.
Corn oil fractionation means a process whereby seeds are divided in
various components and oils are removed prior to fermentation for the
production of ethanol.
Corporate affiliate means one of the following:
(1) Two RIN-holding parties are corporate affiliates if one owns or
controls ownership of more than 20 percent of the other.
(2) Two RIN-holding parties are corporate affiliates if one parent
company owns or controls ownership of more than 20 percent of both.
[[Page 108]]
Corporate affiliate group means a group of parties in which each
party is a corporate affiliate to at least one other party in the group.
Covered location means the contiguous 48 states, Hawaii, and any
state or territory that has received an approval from EPA to opt-in to
the RFS program under Sec. 80.1443.
Crop residue means biomass left over from the harvesting or
processing of planted crops from existing agricultural land and any
biomass removed from existing agricultural land that facilitates crop
management (including biomass removed from such lands in relation to
invasive species control or fire management), whether or not the biomass
includes any portion of a crop or crop plant. Biomass is considered crop
residue only if the use of that biomass for the production of renewable
fuel has no significant impact on demand for the feedstock crop,
products produced from that feedstock crop, and all substitutes for the
crop and its products, nor any other impact that would result in a
significant increase in direct or indirect GHG emissions.
Cropland is land used for production of crops for harvest and
includes cultivated cropland, such as for row crops or close-grown
crops, and non-cultivated cropland, such as for horticultural or aquatic
crops.
Diesel fuel means any of the following:
(1) Any fuel sold in any State or Territory of the United States and
suitable for use in diesel engines, and that is one of the following:
(i) A distillate fuel commonly or commercially known or sold as No.
1 diesel fuel or No. 2 diesel fuel.
(ii) A non-distillate fuel other than residual fuel with comparable
physical and chemical properties (e.g., biodiesel fuel).
(iii) A mixture of fuels meeting the criteria of paragraphs (1)(i)
and (ii) of this definition.
(2) For purposes of subpart M of this part, any and all of the
products specified at Sec. 80.1407(e).
Digestate means the material that remains following the anaerobic
digestion of renewable biomass in an anaerobic digester. Digestate must
only contain the leftovers that were unable to be completely converted
to biogas in an anaerobic digestor that is part of an EPA-accepted
registration under Sec. 80.1450.
Distillate fuel means diesel fuel and other petroleum fuels that can
be used in engines that are designed for diesel fuel. For example, jet
fuel, heating oil, kerosene, No. 4 fuel, DMX, DMA, DMB, and DMC are
distillate fuels; and natural gas, LPG, gasoline, and residual fuel are
not distillate fuels. Blends containing residual fuel may be distillate
fuels.
Distillers corn oil means corn oil recovered at any point downstream
of when a dry mill ethanol or butanol plant grinds the corn, provided
that the corn starch is converted to ethanol or butanol, the recovered
oil is unfit for human food use without further refining, and the
distillers grains remaining after the dry mill and oil recovery
processes are marketable as animal feed.
Distillers sorghum oil means grain sorghum oil recovered at any
point downstream of when a dry mill ethanol or butanol plant grinds the
grain sorghum, provided that the grain sorghum is converted to ethanol
or butanol, the recovered oil is unfit for human food use without
further refining, and the distillers grains remaining after the dry mill
and oil recovery processes are marketable as animal feed.
Distributor means any person who transports or stores or causes the
transportation or storage of gasoline or diesel fuel at any point
between any gasoline or diesel fuel refinery or importer's facility and
any retail outlet or wholesale purchaser-consumer's facility.
DX RIN means a RIN with a D code of X, where X is the D code of the
renewable fuel as identified under Sec. 80.1425(g), generated under
Sec. 80.1426, and submitted under Sec. 80.1452. For example, a D6 RIN
is a RIN with a D code of 6.
ECA marine fuel is diesel, distillate, or residual fuel that meets
the criteria of paragraph (1) of this definition, but not the criteria
of paragraph (2) of this definition.
(1) All diesel, distillate, or residual fuel used, intended for use,
or made available for use in Category 3 marine vessels while the vessels
are operating
[[Page 109]]
within an Emission Control Area (ECA), or an ECA associated area, is ECA
marine fuel, unless it meets the criteria of paragraph (2) of this
definition.
(2) ECA marine fuel does not include any of the following fuel:
(i) Fuel used by exempted or excluded vessels (such as exempted
steamships), or fuel used by vessels allowed by the U.S. government
pursuant to MARPOL Annex VI Regulation 3 or Regulation 4 to exceed the
fuel sulfur limits while operating in an ECA or an ECA associated area
(see 33 U.S.C. 1903).
(ii) Fuel that conforms fully to the requirements of this part for
MVNRLM diesel fuel (including being designated as MVNRLM).
(iii) Fuel used, or made available for use, in any diesel engines
not installed on a Category 3 marine vessel.
Ecologically sensitive forestland means forestland that meets either
of the following criteria:
(1) An ecological community with a global or state ranking of
critically imperiled, imperiled or rare pursuant to a State Natural
Heritage Program. For examples of such ecological communities, see
``Listing of Forest Ecological Communities Pursuant to 40 CFR 80.1401;
S1-S3 communities,'' which is number EPA-HQ-OAR-2005-0161-1034.1 in the
public docket, and ``Listing of Forest Ecological Communities Pursuant
to 40 CFR 80.1401; G1-G2 communities,'' which is number EPA-HQ-OAR-2005-
0161-2906.1 in the public docket. This material is available for
inspection at the EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW, Washington, DC. The telephone number for the Air
Docket is (202) 566-1742.
(2) Old growth or late successional, characterized by trees at least
200 years in age.
End of day means 7 a.m. Coordinated Universal Time (UTC).
Energy cane means a complex hybrid in the Saccharum genus that has
been bred to maximize cellulosic rather than sugar content. For the
purposes of this part:
(1) Energy cane excludes the species Saccharum spontaneum, but may
include hybrids derived from S. spontaneum that have been developed and
publicly released by USDA; and
(2) Energy cane only includes cultivars that have, on average, at
least 75% adjusted cellulosic content on a dry mass basis.
EPA Moderated Transaction System (EMTS) means a closed, EPA
moderated system that provides a mechanism for screening and tracking
RINs under Sec. 80.1452.
Existing agricultural land is cropland, pastureland, and land
enrolled in the Conservation Reserve Program (administered by the U.S.
Department of Agriculture's Farm Service Agency) that was cleared or
cultivated prior to December 19, 2007, and that, on December 19, 2007,
was:
(1) Nonforested; and
(2) Actively managed as agricultural land or fallow, as evidenced by
records which must be traceable to the land in question, which must
include one of the following:
(i) Records of sales of planted crops, crop residue, or livestock,
or records of purchases for land treatments such as fertilizer, weed
control, or seeding.
(ii) A written management plan for agricultural purposes.
(iii) Documented participation in an agricultural management program
administered by a Federal, state, or local government agency.
(iv) Documented management in accordance with a certification
program for agricultural products.
Exporter of renewable fuel means all buyers, sellers, and owners of
the renewable fuel in any transaction that results in renewable fuel
being transferred from a covered location to a destination outside of
the covered locations.
Facility means all of the activities and equipment associated with
the production of renewable fuel, biogas, treated biogas, RNG, or a
biointermediate--starting from the point of delivery of feedstock
material to the point of final storage of the end product--that are
located on one property and are under the control of the same person (or
persons under common control).
Fallow means cropland, pastureland, or land enrolled in the
Conservation Reserve Program (administered by the
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U.S. Department of Agriculture's Farm Service Agency) that is
intentionally left idle to regenerate for future agricultural purposes
with no seeding or planting, harvesting, mowing, or treatment during the
fallow period.
Feedstock aggregator means any person who collects feedstock from
feedstock suppliers or other feedstock aggregators and distributes such
feedstock to a renewable fuel producer, biointermediate producer, or
other feedstock aggregator.
Feedstock supplier means any person who generates and supplies
feedstock to a feedstock aggregator, renewable fuel producer, biogas
producer, or biointermediate producer.
Foreign biogas producer means any person who owns, leases, operates,
controls, or supervises a biogas production facility outside of the
United States.
Foreign ethanol producer means a foreign renewable fuel producer who
produces ethanol for use in transportation fuel, heating oil, or jet
fuel but who does not add ethanol denaturant to their product as
specified in paragraph (2) of the definition of ``renewable fuel'' in
this section.
Foreign renewable fuel producer means a person from a foreign
country or from an area outside the covered location who produces
renewable fuel for use in transportation fuel, heating oil, or jet fuel
for export to the covered location. Foreign ethanol producers are
considered foreign renewable fuel producers.
Foreign RNG producer means any person who owns, leases, operates,
controls, or supervises an RNG production facility outside of the United
States.
Forestland is generally undeveloped land covering a minimum area of
1 acre upon which the primary vegetative species are trees, including
land that formerly had such tree cover and that will be regenerated and
tree plantations. Tree-covered areas in intensive agricultural crop
production settings, such as fruit orchards, or tree-covered areas in
urban settings, such as city parks, are not considered forestland.
Free fatty acid (FFA) feedstock means a biointermediate that is
composed of at least 50 percent free fatty acids. FFA feedstock must not
include any free fatty acids from the refining of crude palm oil.
Fuel for use in an ocean-going vessel means, for this part only:
(1) Any marine residual fuel (whether burned in ocean waters, Great
Lakes, or other internal waters);
(2) Emission Control Area (ECA) marine fuel, pursuant to Sec. 80.2
and 40 CFR 1090.80 (whether burned in ocean waters, Great Lakes, or
other internal waters); and
(3) Any other fuel intended for use only in ocean-going vessels.
Gasoline means any of the following:
(1) Any fuel sold in the United States for use in motor vehicles and
motor vehicle engines, and commonly or commercially known or sold as
gasoline.
(2) For purposes of subpart M of this part, any and all of the
products specified at Sec. 80.1407(c).
Gasoline blendstock or component means any liquid compound that is
blended with other liquid compounds to produce gasoline.
Gasoline blendstock for oxygenate blending (BOB) has the meaning
given in 40 CFR 1090.80.
Gasoline treated as blendstock (GTAB) means imported gasoline that
is excluded from an import facility's compliance calculations, but is
treated as blendstock in a related refinery that includes the GTAB in
its refinery compliance calculations.
Glycerin means a coproduct from the production of biodiesel that
primarily contains glycerol.
Heating oil means any of the following:
(1) Any No. 1, No. 2, or non-petroleum diesel blend that is sold for
use in furnaces, boilers, and similar applications and which is commonly
or commercially known or sold as heating oil, fuel oil, and similar
trade names, and that is not jet fuel, kerosene, or MVNRLM diesel fuel.
(2) Any fuel oil that is used to heat or cool interior spaces of
homes or buildings to control ambient climate for human comfort. The
fuel oil must be liquid at STP and contain no more than 2.5% mass
solids.
Importer means any person who imports transportation fuel or
renewable fuel into the covered location from an area outside of the
covered location.
[[Page 111]]
Independent third-party auditor means a party meeting the
requirements of Sec. 80.1471(b) that conducts QAP audits and verifies
RINs, biointermediates, or biogas.
Interim period means the period between February 21, 2013, and
December 31, 2014.
Jet fuel means any distillate fuel used, intended for use, or made
available for use in aircraft.
Kerosene means any No.1 distillate fuel commonly or commercially
sold as kerosene.
Liquefied petroleum gas (LPG) means a liquid hydrocarbon fuel that
is stored under pressure and is composed primarily of species that are
gases at atmospheric conditions (temperature = 25 [deg]C and pressure =
1 atm), excluding natural gas.
Locomotive engine means an engine used in a locomotive as defined
under 40 CFR 92.2.
Marine engine has the meaning given in 40 CFR 1042.901.
Membrane separation means the process of dehydrating ethanol to fuel
grade (99.5% purity) using a hydrophilic membrane.
Mixed digester means an anaerobic digester that has received
feedstocks under both an approved pathway with D code 3 or 7 and an
approved pathway with D code 5 during the current calendar month or the
previous two calendar months.
Motor vehicle has the meaning given in Section 216(2) of the Clean
Air Act (42 U.S.C. 7550(2)).
Municipal wastewater treatment facility digester means an anaerobic
digester that processes only municipal wastewater treatment plant sludge
with an adjusted cellulosic content of at least 75%.
MVNRLM diesel fuel means any diesel fuel or other distillate fuel
that is used, intended for use, or made available for use in motor
vehicles or motor vehicle engines, or as a fuel in any nonroad diesel
engines, including locomotive and marine diesel engines, except the
following: Distillate fuel with a T90 at or above 700 [deg]F that is
used only in Category 2 and 3 marine engines is not MVNRLM diesel fuel,
and ECA marine fuel is not MVNRLM diesel fuel (note that fuel that
conforms to the requirements of MVNRLM diesel fuel is excluded from the
definition of ``ECA marine fuel'' in this section without regard to its
actual use). Use the distillation test method specified in 40 CFR
1065.1010 to determine the T90 of the fuel.
(1) Any diesel fuel that is sold for use in stationary engines that
are required to meet the requirements of 40 CFR 1090.300, when such
provisions are applicable to nonroad engines, is considered MVNRLM
diesel fuel.
(2) [Reserved]
Nameplate capacity means the peak design capacity of a facility for
the purposes of registration of a facility under this part.
Naphtha means a blendstock or fuel blending component falling within
the boiling range of gasoline, which is composed of only hydrocarbons,
is commonly or commercially known as naphtha, and is used to produce
gasoline or E85 (as defined in 40 CFR 1090.80) through blending.
Natural gas means a fuel whose primary constituent is methane.
Natural gas includes RNG.
Natural gas commercial pipeline system means one or more connected
pipelines that transport natural gas that meets all the following:
(1) The natural gas originates from multiple parties.
(2) The natural gas meets specifications set by the pipeline owner
or operator.
(3) The natural gas is delivered to multiple parties in the covered
location.
Neat renewable fuel is a renewable fuel to which 1% or less of
gasoline (as defined in this section) or diesel fuel has been added.
Non-ester renewable diesel or renewable diesel means renewable fuel
that is not a mono-alkyl ester and that is either:
(1) A fuel or fuel additive that meets the Grade No. 1-D or No. 2-D
specification in ASTM D975 (incorporated by reference, see Sec. 80.12)
and can be used in an engine designed to operate on conventional diesel
fuel; or
(2) A fuel or fuel additive that is registered under 40 CFR part 79
and can be used in an engine designed to operate using conventional
diesel fuel.
[[Page 112]]
Nonforested land means land that is not forestland.
Non-petroleum diesel means a diesel fuel that contains at least 80
percent mono-alkyl esters of long chain fatty acids derived from
vegetable oils or animal fats.
Non-qualifying fuel use means a use of renewable fuel in an
application other than transportation fuel, heating oil, or jet fuel.
Non-renewable component means any material (or any portion thereof)
blended into biogas or RNG that does not meet the definition of
renewable biomass.
Non-renewable feedstock means a feedstock (or any portion thereof)
that does not meet the definition of renewable biomass or
biointermediate.
Non-RIN-generating foreign producer means a foreign renewable fuel
producer that has been registered by EPA to produce renewable fuel for
which RINs have not been generated.
Nonroad diesel engine means an engine that is designed to operate
with diesel fuel that meets the definition of nonroad engine in 40 CFR
1068.30, including locomotive and marine diesel engines.
Nonroad vehicle has the meaning given in Section 216(11) of the
Clean Air Act (42 U.S.C. 7550(11)).
Obligated party means any refiner that produces gasoline or diesel
fuel within the covered location, or any importer that imports gasoline
or diesel fuel into the covered location, during a compliance period. A
party that simply blends renewable fuel into gasoline or diesel fuel, as
specified in Sec. 80.1407(c) or (e), is not an obligated party.
Ocean-going vessel means vessels that are equipped with engines
meeting the definition of ``Category 3'' in 40 CFR 1042.901.
Oxygenate means any substance which, when added to gasoline,
increases the oxygen content of that gasoline. Lawful use of any of the
substances or any combination of these substances requires that they be
``substantially similar'' under section 211(f)(1) of the Clean Air Act
(42 U.S.C. 7545(f)(1)), or be permitted under a waiver granted by EPA
under the authority of section 211(f)(4) of the Clean Air Act (42 U.S.C.
7545(f)(4)).
Oxygenated gasoline means gasoline which contains a measurable
amount of oxygenate.
Pastureland is land managed for the production of select indigenous
or introduced forage plants for livestock grazing or hay production, and
to prevent succession to other plant types.
Permitted capacity means 105% of the maximum permissible volume
output of renewable fuel that is allowed under operating conditions
specified in the most restrictive of all applicable preconstruction,
construction and operating permits issued by regulatory authorities
(including local, regional, state or a foreign equivalent of a state,
and federal permits, or permits issued by foreign governmental agencies)
that govern the construction and/or operation of the renewable fuel
facility, based on an annual volume output on a calendar year basis. If
the permit specifies maximum rated volume output on an hourly basis,
then annual volume output is determined by multiplying the hourly output
by 8,322 hours per year.
(1) For facilities that commenced construction prior to December 19,
2007, the permitted capacity is based on permits issued or revised no
later than December 19, 2007.
(2) For facilities that commenced construction after December 19,
2007 and before January 1, 2010 that are fired with natural gas,
biomass, or a combination thereof, the permitted capacity is based on
permits issued or revised no later than December 31, 2009.
(3) For facilities other than those specified in paragraphs (1) and
(2) of this definition, permitted capacity is based on the most recent
applicable permits.
Pipeline interconnect means the physical injection or withdrawal
point where RNG is injected or withdrawn into or from the natural gas
commercial pipeline system.
Planted crops are all annual or perennial agricultural crops from
existing agricultural land that may be used as feedstocks for renewable
fuel, such as grains, oilseeds, sugarcane, switchgrass, prairie grass,
duckweed, and other species (but not including
[[Page 113]]
algae species or planted trees), providing that they were intentionally
applied by humans to the ground, a growth medium, a pond or tank, either
by direct application as seed or plant, or through intentional natural
seeding or vegetative propagation by mature plants introduced or left
undisturbed for that purpose.
Planted trees are trees harvested from a tree plantation.
Pre-commercial thinnings are trees, including unhealthy or diseased
trees, removed to reduce stocking to concentrate growth on more
desirable, healthy trees, or other vegetative material that is removed
to promote tree growth.
Professional liability insurance means insurance coverage for
liability arising out of the performance of professional or business
duties related to a specific occupation, with coverage being tailored to
the needs of the specific occupation. Examples include abstracters,
accountants, insurance adjusters, architects, engineers, insurance
agents and brokers, lawyers, real estate agents, stockbrokers, and
veterinarians. For purposes of this definition, professional liability
insurance does not include directors and officers liability insurance.
Q-RIN means a RIN verified by a registered independent third-party
auditor using a QAP that has been approved under Sec. 80.1469(c)
following the audit process specified in Sec. 80.1472.
Quality assurance audit means an audit of a renewable fuel
production facility or biointermediate production facility conducted by
an independent third-party auditor in accordance with a QAP that meets
the requirements of Sec. Sec. 80.1469, 80.1472, and 80.1477.
Quality assurance plan (QAP) means the list of elements that an
independent third-party auditor will check to verify that the RINs
generated by a renewable fuel producer or importer are valid or to
verify the appropriate production of a biointermediate. A QAP includes
both general and pathway specific elements.
Raw starch hydrolysis means the process of hydrolyzing corn starch
into simple sugars at low temperatures, generally not exceeding 100
[deg]F (38 [deg]C), using enzymes designed to be effective under these
conditions.
Refiner means any person who owns, leases, operates, controls, or
supervises a refinery.
Refinery means any facility, including but not limited to, a plant,
tanker truck, or vessel where gasoline or diesel fuel is produced,
including any facility at which blendstocks are combined to produce
gasoline or diesel fuel, or at which blendstock is added to gasoline or
diesel fuel.
Reformulated gasoline (RFG) means any gasoline whose formulation has
been certified under 40 CFR 1090.1000(b), and which meets each of the
standards and requirements prescribed under 40 CFR 1090.220.
Reformulated gasoline blendstock for oxygenate blending (RBOB) means
a petroleum product that, when blended with a specified type and
percentage of oxygenate, meets the definition of reformulated gasoline,
and to which the specified type and percentage of oxygenate is added
other than by the refiner or importer of the RBOB at the refinery or
import facility where the RBOB is produced or imported.
Renewable biomass means each of the following (including any
incidental, de minimis contaminants that are impractical to remove and
are related to customary feedstock production and transport):
(1) Planted crops and crop residue harvested from existing
agricultural land cleared or cultivated prior to December 19, 2007 and
that was nonforested and either actively managed or fallow on December
19, 2007.
(2) Planted trees and tree residue from a tree plantation located on
non-federal land (including land belonging to an Indian tribe or an
Indian individual that is held in trust by the U.S. or subject to a
restriction against alienation imposed by the U.S.) that was cleared at
any time prior to December 19, 2007 and actively managed on December 19,
2007.
(3) Animal waste material and animal byproducts.
(4) Slash and pre-commercial thinnings from non-federal forestland
(including forestland belonging to an Indian tribe or an Indian
individual, that are held in trust by the United
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States or subject to a restriction against alienation imposed by the
United States) that is not ecologically sensitive forestland.
(5) Biomass (organic matter that is available on a renewable or
recurring basis) obtained from within 200 feet of buildings and other
areas regularly occupied by people, or of public infrastructure, in an
area at risk of wildfire.
(6) Algae.
(7) Separated yard waste or food waste, including recycled cooking
and trap grease.
Renewable compressed natural gas or renewable CNG means biogas,
treated biogas, or RNG that is compressed for use as transportation fuel
and meets the definition of renewable fuel.
Renewable electricity means electricity that meets the definition of
renewable fuel.
Renewable fuel means a fuel that meets all the following
requirements:
(1)(i) Fuel that is produced either from renewable biomass or from a
biointermediate produced from renewable biomass.
(ii) Fuel that is used in the covered location to replace or reduce
the quantity of fossil fuel present in a transportation fuel, heating
oil, or jet fuel.
(iii) Has lifecycle greenhouse gas emissions that are at least 20
percent less than baseline lifecycle greenhouse gas emissions, unless
the fuel is exempt from this requirement pursuant to Sec. 80.1403.
(2) Ethanol covered by this definition must be denatured using an
ethanol denaturant as required in 27 CFR parts 19 through 21. Any volume
of ethanol denaturant added to the undenatured ethanol by a producer or
importer in excess of 2 volume percent must not be included in the
volume of ethanol for purposes of determining compliance with the
requirements of this part.
Renewable gasoline means renewable fuel produced from renewable
biomass that is composed of only hydrocarbons and that meets the
definition of gasoline.
Renewable gasoline blendstock means a blendstock produced from
renewable biomass that is composed of only hydrocarbons and which meets
the definition of gasoline blendstock in Sec. 80.2.
Renewable Identification Number (RIN) is a unique number generated
to represent a volume of renewable fuel pursuant to Sec. Sec. 80.1425
and 80.1426.
(1) Gallon-RIN is a RIN that represents an individual gallon of
renewable fuel used for compliance purposes pursuant to Sec. 80.1427 to
satisfy a renewable volume obligation.
(2) Batch-RIN is a RIN that represents multiple gallon-RINs.
Renewable liquefied natural gas or renewable LNG means biogas,
treated biogas, or RNG that is liquified (i.e., it is cooled below its
boiling point) for use as transportation fuel and meets the definition
of renewable fuel.
Renewable natural gas (RNG) means a product that meets all the
following requirements:
(1) It is produced from biogas.
(2) It does not require removal of additional components to be
suitable for injection into the natural gas commercial pipeline system.
(3) It is used to produce renewable fuel.
Residual fuel means a petroleum fuel that can only be used in diesel
engines if it is preheated before injection. For example, No. 5 fuels,
No. 6 fuels, and RM grade marine fuels are residual fuels. Note:
Residual fuels do not necessarily require heating for storage or
pumping.
Responsible corporate officer (RCO) has the meaning given in 40 CFR
1090.80.
Retail outlet means any establishment at which gasoline, diesel
fuel, natural gas or liquefied petroleum gas is sold or offered for sale
for use in motor vehicles or nonroad engines, including locomotive or
marine engines.
Retailer means any person who owns, leases, operates, controls, or
supervises a retail outlet.
RIN-generating foreign producer means a foreign renewable fuel
producer that has been registered by EPA to generate RINs for renewable
fuel it produces.
RIN generator means any party allowed to generate RINs under this
part.
RIN-less RNG means RNG produced by a foreign RNG producer and for
which RINs were not generated by the foreign RNG producer.
RNG importer means any person who imports RNG into the covered
location
[[Page 115]]
and generates RINs for the RNG as specified in Sec. 80.125.
RNG producer means any person who owns, leases, operates, controls,
or supervises an RNG production facility.
RNG production facility means a facility where biogas is upgraded to
RNG under an approved pathway.
RNG RIN separator means any person registered to separate RINs for
RNG under Sec. 80.125(d).
RNG used as a feedstock or RNG as a feedstock means any RNG used to
produce renewable fuel under Sec. 80.125.
Separated food waste means a feedstock stream consisting of food
waste kept separate since generation from other waste materials, and
which includes food and beverage production waste and post-consumer food
and beverage waste.
Separated municipal solid waste or separated MSW means material
remaining after separation actions have been taken to remove recyclable
paper, cardboard, plastics, rubber, textiles, metals, and glass from
municipal solid waste, and which is composed of both cellulosic and non-
cellulosic materials.
Separated RIN means a RIN with a K code of 2 that has been separated
from a volume of renewable fuel or RNG pursuant to Sec. 80.1429.
Separated yard waste means a feedstock stream consisting of yard
waste kept separate since generation from other waste materials.
Slash is the residue, including treetops, branches, and bark, left
on the ground after logging or accumulating as a result of a storm,
fire, delimbing, or other similar disturbance.
Small refinery means a refinery for which the average aggregate
daily crude oil throughput (as determined by dividing the aggregate
throughput for the calendar year by the number of days in the calendar
year) does not exceed 75,000 barrels.
Soapstock means an emulsion, or the oil obtained from separation of
that emulsion, produced by washing oils listed as a feedstock in an
approved pathway with water.
Standard temperature and pressure (STP) means 60 degrees Fahrenheit
and 1 atmosphere of pressure.
Transportation fuel means fuel for use in motor vehicles, motor
vehicle engines, nonroad vehicles, or nonroad engines (except fuel for
use in ocean-going vessels).
Treated biogas means a product that meets all the following
requirements:
(1) It is produced from biogas.
(2) It does not require removal of additional components to be
suitable for its designated use (e.g., as a biointermediate or to
produce biogas-derived renewable fuel).
(3) It is used in a biogas closed distribution system as a
biointermediate or to produce biogas-derived renewable fuel.
Tree plantation is a stand of no less than 1 acre composed primarily
of trees established by hand- or machine-planting of a seed or sapling,
or by coppice growth from the stump or root of a tree that was hand- or
machine-planted. Tree plantations must have been cleared prior to
December 19, 2007 and must have been actively managed on December 19,
2007, as evidenced by records which must be traceable to the land in
question, which must include:
(1) Sales records for planted trees or tree residue together with
other written documentation connecting the land in question to these
purchases;
(2) Purchasing records for seeds, seedlings, or other nursery stock
together with other written documentation connecting the land in
question to these purchases;
(3) A written management plan for silvicultural purposes;
(4) Documentation of participation in a silvicultural program
sponsored by a Federal, state, or local government agency;
(5) Documentation of land management in accordance with an
agricultural or silvicultural product certification program;
(6) An agreement for land management consultation with a
professional forester that identifies the land in question; or
(7) Evidence of the existence and ongoing maintenance of a road
system or other physical infrastructure designed and maintained for
logging use, together with one of the above-mentioned documents.
[[Page 116]]
Tree residue is slash and any woody residue generated during the
processing of planted trees from tree plantations for use in lumber,
paper, furniture, or other applications, provided that such woody
residue is not mixed with similar residue from trees that do not
originate in tree plantations.
Undenatured ethanol means a liquid that meets one of the definitions
in paragraph (1) of this definition:
(1)(i) Ethanol that has not been denatured as required in 27 CFR
parts 19 through 21.
(ii) Specially denatured alcohol as defined in 27 CFR 21.11.
(2) Undenatured ethanol is not renewable fuel.
United States has the meaning given in 40 CFR 1090.80.
Verification status means a description of whether biogas, treated
biogas, RNG, or a RIN has been verified under an EPA-approved quality
assurance plan.
Verified RIN means a RIN generated by a renewable fuel producer that
was subject to a QAP audit executed by an independent third-party
auditor, and determined by the independent third-party auditor to be
valid. Verified RINs includes A-RINs, B-RINs, and Q-RINs.
Wholesale purchaser-consumer means any person that is an ultimate
consumer of gasoline, diesel fuel, natural gas, or liquefied petroleum
gas and which purchases or obtains gasoline, diesel fuel, natural gas or
liquefied petroleum gas from a supplier for use in motor vehicles or
nonroad engines, including locomotive or marine engines and, in the case
of gasoline, diesel fuel, or liquefied petroleum gas, receives delivery
of that product into a storage tank of at least 550-gallon capacity
substantially under the control of that person.
[88 FR 44555, July 12, 2023]
Sec. 80.3 Acronyms and abbreviations.
------------------------------------------------------------------------
------------------------------------------------------------------------
AB................................ Advanced biofuel.
APHA.............................. American Public Health Association.
API............................... American Petroleum Institute.
ASTM.............................. ASTM International.
BBD............................... Biomass-based diesel.
BMP............................... Best management practices.
BOB............................... Gasoline before oxygenate blending.
CAA............................... Clean Air Act.
CB................................ Cellulosic biofuel.
CBOB.............................. Conventional gasoline before
oxygenate blending.
CF................................ Converted fraction.
CG................................ Conventional gasoline.
CHP............................... Combined heat and power.
CNG............................... Compressed natural gas.
CPI-U............................. Consumer Price Index for All Urban
Consumers.
ECA............................... Emission Control Area.
EDRR.............................. Early detection and rapid response.
EIA............................... Energy Information Administration.
EMTS.............................. EPA Moderated Transaction System.
EPA............................... Environmental Protection Agency.
EqV............................... Equivalence value.
ERVO.............................. Exporter renewable volume
obligation.
FE................................ Feedstock energy.
FFA............................... Free-fatty acid.
GC................................ Gas chromatography.
GHG............................... Greenhouse gas.
GTAB.............................. Gasoline treated as blendstock.
HACCP............................. Hazard Analysis Critical Control
Point.
HHV............................... Higher heating value.
IBR............................... Incorporation by reference.
ID................................ Identification.
kWh............................... Kilowatt-hour.
LE................................ Limited exemption.
LHV............................... Lower heating value.
LNG............................... Liquified natural gas.
MSW............................... Municipal solid waste.
MVNRLM............................ Motor vehicle, nonroad, locomotive,
or marine.
NARA.............................. National Archives and Records
Administration.
NTDF.............................. Non-transportation 15 ppm distillate
fuel.
PIR............................... Potentially invalid RIN.
PM10.............................. Particulate matter generally 10
micrometers or smaller.
PM2.5............................. Particulate matter generally 2.5
micrometers or smaller.
PTD............................... Product transfer document.
QAP............................... Quality assurance plan.
RBOB.............................. Reformulated gasoline before
oxygenate blending.
RCO............................... Responsible corporate officer.
RF................................ Renewable fuel.
RFS............................... Renewable Fuel Standard.
RFS-FRRF.......................... RFS foreign refiner renewable fuel.
RIN............................... Renewable identification number.
RNG............................... Renewable natural gas.
RVO............................... Renewable volume obligation.
STP............................... Standard temperature and pressure.
U.S............................... United States.
ULSD.............................. Ultra-low-sulfur diesel fuel.
USDA.............................. United States Department of
Agriculture.
UTC............................... Coordinated Universal Time.
VCSB.............................. Voluntary consensus standards body.
------------------------------------------------------------------------
[88 FR 44562, July 12, 2023]
Sec. 80.4 Right of entry; tests and inspections.
EPA, upon presentation of appropriate credentials, shall have a
right to enter upon or through any refinery, retail outlet, wholesale
purchaser-consumer facility, or detergent manufacturer facility; or the
premises or property of any gasoline or detergent distributor, carrier,
or importer; or any
[[Page 117]]
place where gasoline or detergent is stored; and shall have the right to
make inspections, take samples, obtain information and records, and
conduct tests to determine compliance with the requirements of this
part.
[61 FR 35356, July 5, 1996, as amended at 88 FR 44562, July 12, 2023]
Sec. 80.5 Penalties.
Any person who violates these regulations shall be liable to the
United States for a civil penalty of not more than the sum of $25,000
for every day of such violation and the amount of economic benefit or
savings resulting from the violation. Any violation with respect to a
regulation proscribed under section 211(c), (k), (l) or (m) of the Act
which establishes a regulatory standard based upon a multi-day averaging
period shall constitute a separate day of violation for each and every
day in the averaging period. Civil penalties shall be assessed in
accordance with section 205(b) and (c) of the Act.
[58 FR 65554, Dec. 15, 1993]
Sec. 80.7 Requests for information.
(a) When EPA has reason to believe that a violation of section
211(c) or section 211(n) of the Clean Air Act and the regulations
thereunder has occurred, EPA may require any refiner, distributor,
wholesale purchaser-consumer, or retailer to report the following
information regarding receipt, transfer, delivery, or sale of gasoline
represented to be unleaded gasoline and to allow the reproduction of
such information at all reasonable times.
(1) For any bulk shipment of gasoline represented to be unleaded
gasoline which is transferred, sold, or delivered within the previous 6
months by a refiner or a distributor to a distributor, wholesale
purchaser-consumer or a retail outlet, the refiner or distributor shall
maintain and provide the following information as applicable:
(i) Business or corporate name and address of distributors,
wholesale purchaser-consumers or retail outlets to which the gasoline
has been transferred, sold, or delivered.
(ii) Quantity of gasoline involved.
(iii) Date of delivery.
(iv) Storage location of gasoline prior to transit via delivery
vessel (e.g., location of a bulk terminal).
(v) Business or corporate name and address of the person who
delivered the gasoline.
(vi) Identification of delivery vessel (e.g., truck number). This
information shall be supplied by the person in paragraph (a)(1)(v) of
this section who performed the delivery, e.g., common or contract
carrier.
(2) For any bulk shipment of gasoline represented to be unleaded
gasoline received by a retail outlet or a wholesale-purchaser-consumer
facility within the previous 6 months, whether by purchase or otherwise,
the retailer or wholesale purchaser-consumer shall maintain
accessibility to and provide the following information:
(i) Business or corporate name and address of the distributor.
(ii) Quantity of gasoline received.
(iii) Date of receipt.
(b) Upon request by EPA, any retailer shall provide documentation of
his annual total sales volume in gallons of gasoline for each retail
outlet for each calendar year beginning with 1971.
(c) Any refiner, distributor, wholesale purchaser-consumer,
retailer, or importer must provide such other information as EPA may
reasonably require to enable the Agency to determine whether such
refiner, distributor, wholesale purchaser-consumer, retailer, or
importer has acted or is acting in compliance with sections 211(c) and
211(n) of the Clean Air Act and the regulations thereunder and must,
upon request of EPA, produce and allow reproduction of any relevant
records at all reasonable times. Such information may include but is not
limited to records of unleaded gasoline inventory at a wholesale
purchaser-consumer facility or a retail outlet, unleaded pump meter
readings at a wholesale purchaser-consumer facility or a retail outlet,
and receipts providing the date of acquisition of signs, labels, and
nozzles required by 40 CFR 1090.1550. No
[[Page 118]]
person shall be required to furnish information requested under this
paragraph if he can establish that such information is not maintained in
the normal course of his business.
(Secs. 211, 301, Clean Air Act, as amended (42 U.S.C. 1857f-6c, 1857g))
[40 FR 36336, Aug. 20, 1975, as amended at 42 FR 45307, Sept. 9, 1977;
47 FR 49332, Oct. 29, 1982; 61 FR 3837, Feb. 2, 1996; 85 FR 78467, Dec.
4, 2020; 88 FR 44562, July 12, 2023]
Sec. 80.8 Sampling methods for gasoline, diesel fuel, fuel additives,
and renewable fuels.
(a) Manual sampling. Manual sampling of tanks and pipelines shall be
performed according to the applicable procedures specified in ASTM D4057
(incorporated by reference, see Sec. 80.12).
(b) Automatic sampling. Automatic sampling of petroleum products in
pipelines shall be performed according to the applicable procedures
specified in ASTM D4177 (incorporated by reference, see Sec. 80.12).
(c) Sampling and sample handling for volatility measurement. Samples
to be analyzed for Reid Vapor Pressure (RVP) shall be collected and
handled according to the applicable procedures specified in ASTM D5842
(incorporated by reference, see Sec. 80.12).
(d) Sample compositing. Composite samples shall be prepared using
the applicable procedures specified in ASTM D5854 (incorporated by
reference, see Sec. 80.12).
[88 FR 44563, July 12, 2023]
Sec. 80.9 Rounding.
(a) Test results and calculated values reported to EPA under this
part must be rounded according to 40 CFR 1090.50(a) through (d).
(b) Calculated values under this part may only be rounded when
reported to EPA.
(c) Reported values under this part must be submitted using forms
and procedures specified by EPA.
[88 FR 44563, July 12, 2023]
Sec. 80.10 Addresses.
(a) For submitting notifications, applications, petitions, or other
communications with EPA, use one of the following addresses for mailing:
(1) For U.S. Mail: Attn: [TITLE AS DIRECTED], U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Mail Code 6405A,
Washington, DC 20460.
(2) For commercial service: Attn: [TITLE AS DIRECTED], U.S.
Environmental Protection Agency, William Jefferson Clinton Building
North, Mail Code 6405A, Room 6520V, 1200 Pennsylvania Ave. NW,
Washington, DC 20004; Phone: 1-800-385-6164.
(b) [Reserved]
[85 FR 7070, Feb. 6, 2020]
Sec. 80.11 Confidentiality of information.
(a) Except as specified in paragraph (b) of this section,
information obtained by the Administrator or his representatives
pursuant to this part shall be treated, in so far as its confidentiality
is concerned, in accordance with the provisions of 40 CFR part 2,
subpart B.
(b) Information contained in EPA notices of violation, settlement
agreements, administrative complaints, civil complaints, criminal
information, and criminal indictments is not entitled to confidential
treatment and therefore EPA may publicly disclose such information. Such
information includes the company name and EPA-issued company
identification number, the facility name and EPA-issued facility
identification number, the total quantity of fuel and parameter, the
time or time period when the violation occurred, information relating to
the generation, transfer, or use of credits, and any other information
relevant to describing the violation.
[87 FR 39659, July 1, 2022]
Sec. 80.12 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register under 5 U.S.C.
552(a) and 1 CFR part 51. All approved incorporation by reference (IBR)
material is available for inspection at U.S. EPA and at the National
Archives and Records Administration (NARA). Contact U.S. EPA at: U.S.
EPA, Air and Radiation Docket and Information Center, WJC West Building,
Room 3334,
[[Page 119]]
1301 Constitution Ave. NW, Washington, DC 20460; (202) 566-1742. For
information on the availability of this material at NARA, visit:
www.archives.gov/federal-register/cfr/ibr-locations.html or email
[email protected]. The material may be obtained from the following
sources:
(a) American Petroleum Institute (API), 200 Massachusetts Avenue NW,
Suite 1100, Washington, DC 20001-5571; (202) 682-8000; www.api.org.
(1) API MPMS 14.1-2016, Manual of Petroleum Measurement Standards
Chapter 14--Natural Gas Fluids Measurement Section 1--Collecting and
Handling of Natural Gas Samples for Custody Transfer, 7th Edition, May
2016 (``API MPMS 14.1''); IBR approved for Sec. 80.155(b).
(2) API MPMS 14.3.1-2012, Manual of Petroleum Measurement Standards
Chapter 14.3.1--Orifice Metering of Natural Gas and Other Related
Hydrocarbon Fluids--Concentric, Square-edged Orifice Meters Part 1:
General Equations and Uncertainty Guidelines, 4th Edition, including
Errata July 2013, Reaffirmed, July 2022 (``API MPMS 14.3.1''); IBR
approved for Sec. 80.155(a).
(3) API MPMS 14.3.2-2016, Manual of Petroleum Measurement Standards
Chapter 14.3.2--Orifice Metering of Natural Gas and Other Related
Hydrocarbon Fluids--Concentric, Square-edged Orifice Meters Part 2:
Specification and Installation Requirements, 5th Edition, March 2016
(``API MPMS 14.3.2''); IBR approved for Sec. 80.155(a).
(4) API MPMS 14.3.3-2013, Manual of Petroleum Measurement Standards
Chapter 14.3.3--Orifice Metering of Natural Gas and Other Related
Hydrocarbon Fluids--Concentric, Square-edged Orifice Meters Part 3:
Natural Gas Applications, 4th Edition, Reaffirmed, June 2021 (``API MPMS
14.3.3''); IBR approved for Sec. 80.155(a).
(5) API MPMS 14.3.4-2019, Manual of Petroleum Measurement Standards
Chapter 14.3.4--Orifice Metering of Natural Gas and Other Related
Hydrocarbon Fluids--Concentric, Square-edged Orifice Meters Part 4--
Background, Development, Implementation Procedure, and Example
Calculations, 4th Edition, October 2019 (``API MPMS 14.3.4''); IBR
approved for Sec. 80.155(a).
(6) API MPMS 14.12-2017, Manual of Petroleum Measurement Standards
Chapter 14--Natural Gas Fluid Measurement Section 12--Measurement of Gas
by Vortex Meters, 1st Edition, March 2017 (``API MPMS 14.12''); IBR
approved for Sec. 80.155(a).
Note 1 to paragraph (a):
API MPMS 14.3.1, 14.3.2, 14.3.3, and 141.3.4, are co-published as
AGA Report 3, Parts 1, 2, 3, and 4, respectively.
(b) American Public Health Association (APHA), 1015 15th Street NW,
Washington, DC 20005; (202) 777-2742; www.standardmethods.org.
(1) SM 2540, revised June 10, 2020; IBR approved for Sec.
80.155(c).
(2) [Reserved]
(c) ASTM International (ASTM), 100 Barr Harbor Dr., P.O. Box C700,
West Conshohocken, PA 19428-2959; (877) 909-2786; www.astm.org.
(1) ASTM D975-21, Standard Specification for Diesel Fuel, approved
August 1, 2021 (``ASTM D975''); IBR approved for Sec. Sec. 80.2;
80.1426(f); 80.1450(b); 80.1451(b); 80.1454(l).
(2) ASTM D1250-19e1, Standard Guide for the Use of the Joint API and
ASTM Adjunct for Temperature and Pressure Volume Correction Factors for
Generalized Crude Oils, Refined Products, and Lubricating Oils: API MPMS
Chapter 11.1, approved May 1, 2019 (``ASTM D1250''); IBR approved for
Sec. 80.1426(f).
(3) ASTM D3588-98 (Reapproved 2017)e1, Standard Practice for
Calculating Heat Value, Compressibility Factor, and Relative Density of
Gaseous Fuels, approved April 1, 2017 (``ASTM D3588''); IBR approved for
Sec. 80.155(b) and (f).
(4) ASTM D4057-12, Standard Practice for Manual Sampling of
Petroleum and Petroleum Products, approved December 1, 2012 (``ASTM
D4057''); IBR approved for Sec. 80.8(a).
(5) ASTM D4177-95 (Reapproved 2010), Standard Practice for Automatic
Sampling of Petroleum and Petroleum Products, approved May 1, 2010
(``ASTM D4177''); IBR approved for Sec. 80.8(b).
(6) ASTM D4442-20, Standard Test Methods for Direct Moisture Content
Measurement of Wood and Wood-Based Materials, approved March 1, 2020
(``ASTM D4442''); IBR approved for Sec. 80.1426(f).
[[Page 120]]
(7) ASTM D4444-13 (Reapproved 2018), Standard Test Method for
Laboratory Standardization and Calibration of Hand-Held Moisture Meters,
reapproved July 1, 2018 (``ASTM D4444''); IBR approved for Sec.
80.1426(f).
(8) ASTM D4888-20, Standard Test Method for Water Vapor in Natural
Gas Using Length-of-Stain Detector Tubes, approved December 15, 2020
(``ASTM D4888''); IBR approved for Sec. 80.155(b).
(9) ASTM D5504-20, Standard Test Method for Determination of Sulfur
Compounds in Natural Gas and Gaseous Fuels by Gas Chromatography and
Chemiluminescence, approved November 1, 2020 (``ASTM D5504''); IBR
approved for Sec. 80.155(b).
(10) ASTM D5842-14, Standard Practice for Sampling and Handling of
Fuels for Volatility Measurement, approved January 15, 2014 (``ASTM
D5842''); IBR approved for Sec. 80.8(c).
(11) ASTM D5854-96 (Reapproved 2010), Standard Practice for Mixing
and Handling of Liquid Samples of Petroleum and Petroleum Products,
approved May 1, 2010 (``ASTM D5854''); IBR approved for Sec. 80.8(d).
(12) ASTM D6751-20a, Standard Specification for Biodiesel Fuel Blend
Stock (B100) for Middle Distillate Fuels, approved August 1, 2020
(``ASTM D6751''); IBR approved for Sec. 80.2.
(13) ASTM D6866-22, Standard Test Methods for Determining the
Biobased Content of Solid, Liquid, and Gaseous Samples Using Radiocarbon
Analysis, approved March 15, 2022 (``ASTM D6866''); IBR approved for
Sec. Sec. 80.155(b); 80.1426(f); 80.1430(e).
(14) ASTM D7164-21, Standard Practice for On-line/At-line Heating
Value Determination of Gaseous Fuels by Gas Chromatography, approved
April 1, 2021 (``ASTM D7164''); IBR approved for Sec. 80.155(a).
(15) ASTM D8230-19, Standard Test Method for Measurement of Volatile
Silicon-Containing Compounds in a Gaseous Fuel Sample Using Gas
Chromatography with Spectroscopic Detection, approved June 1, 2019
(``ASTM D8230''); IBR approved for Sec. 80.155(b).
(16) ASTM E711-87 (Reapproved 2004), Standard Test Method for Gross
Calorific Value of Refuse-Derived Fuel by the Bomb Calorimeter,
reapproved 2004 (``ASTM E711''); IBR approved for Sec. 80.1426(f).
(17) ASTM E870-82 (Reapproved 2019), Standard Test Methods for
Analysis of Wood Fuels, reapproved April 1, 2019 (``ASTM E870''); IBR
approved for Sec. 80.1426(f).
(d) European Committee for Standardization (CEN), Rue de la Science
23, B-1040 Brussels, Belgium; + 32 2 550 08 11; www.cencenelec.eu.
(1) EN 17526:2021(E), Gas meter--Thermal-mass flow-meter based gas
meter, approved July 11, 2021 (``EN 17526''); IBR approved for Sec.
80.155(a).
(2) [Reserved]
[88 FR 44563, July 12, 2023]
Subpart B [Reserved]
Subpart C_Oxygenated Gasoline
Sec. 80.35 Labeling of retail gasoline pumps; oxygenated gasoline.
(a) For oxygenated gasoline programs with a minimum oxygen content
per gallon or minimum oxygen content requirement in conjunction with a
credit program, the following shall apply:
(1) Each gasoline pump stand from which oxygenated gasoline is
dispensed at a retail outlet in the control area shall be affixed during
the control period with a legible and conspicuous label which contains
the following statement:
The gasoline dispensed from this pump is oxygenated and will reduce
carbon monoxide pollution from motor vehicles.
(2) The posting of the above statement shall be in block letters of
no less than 20-point bold type; in a color contrasting with the
intended background. The label shall be placed on the vertical surface
of the pump on each side with gallonage and price meters and shall be on
the upper two-thirds of the pump, clearly readable to the public.
(3) The retailer shall be responsible for compliance with the
labeling requirements of this section.
(b) For oxygenated gasoline programs with a credit program and no
minimum oxygen content requirement, the following shall apply:
(1) Each gasoline pump stand from which oxygenated gasoline is
dispensed
[[Page 121]]
at a retail outlet in the control area shall be affixed during the
control period with a legible and conspicuous label which contains the
following statement:
The fuel dispensed from this pump meets the requirements of the Clean
Air Act as part of a program to reduce carbon monoxide pollution from
motor vehicles.
(2) The posting of the above statement shall be in block letters of
no less than 20-point bold type; in a color contrasting with the
intended background. The label shall be placed on the vertical surface
of the pump on each side with gallonage and price meters and shall be on
the upper two-thirds of the pump, clearly readable to the public.
(3) The retailer shall be responsible for compliance with the
labeling requirements of this section.
[57 FR 47771, Oct. 20, 1992]
Sec. Sec. 80.36-80.39 [Reserved]
Subpart D [Reserved]
Subpart E_Biogas-Derived Renewable Fuel
Source: 88 FR 44564, July 12, 2023, unless otherwise noted.
Sec. 80.100 Scope and application.
(a) Applicability. (1) The provisions of this subpart E apply to all
the following:
(i) Biogas.
(ii) Treated biogas.
(iii) Biogas-derived renewable fuel.
(iv) RNG used to produce a biogas-derived renewable fuel.
(v) RINs generated for RNG or a biogas-derived renewable fuel.
(2) This subpart also specifies requirements for specified parties
that engage in activities associated with the production, distribution,
transfer, or use of biogas, treated biogas, biogas-derived renewable
fuel, RNG used to produce a biogas-derived renewable fuel, and RINs
generated for a biogas-derived renewable fuel under the RFS program.
(b) Relationship to other fuels regulations. (1) The provisions of
subpart M of this part also apply to the parties and products regulated
under this subpart E.
(2) The provisions of 40 CFR part 1090 include provisions that may
apply to the parties and products regulated under this subpart E.
(3) Parties and products subject to this subpart E may need to
register a fuel or fuel additive under 40 CFR part 79.
(c) Geographic scope. RINs must only be generated for biogas-derived
renewable fuel used in the covered location.
(d) Implementation dates--(1) General. The provisions of this
subpart E apply beginning July 1, 2024, unless otherwise specified.
(2) Registration. (i) Parties not registered to generate RINs under
Sec. 80.1426(f)(10)(ii) or (11)(ii) prior to July 1, 2024, must
register with EPA under Sec. 80.135. EPA will not accept registration
submissions for the generation of RINs under Sec. 80.1426(f)(10)(ii)
and (11)(ii) on or after July 1, 2024.
(ii) Parties registered to generate RINs under Sec.
80.1426(f)(10)(ii) or (11)(ii) must submit updated registration
information under Sec. 80.135 no later than October 1, 2024.
(iii) Independent third-party engineers may conduct engineering
reviews for parties required to register under Sec. 80.135 prior to
July 1, 2024, as long as the engineering review satisfies all applicable
requirements under Sec. Sec. 80.135 and 80.1450.
(3) Generation of RINs for RNG. RNG producers may only generate RINs
for RNG produced on or after July 1, 2024, as specified in Sec. 80.125.
(4) Generation of RINs for renewable CNG/LNG for previously
registered facilities. (i)(A) Prior to January 1, 2025, RIN generators
may generate RINs as specified in Sec. 80.1426(f)(10)(ii) or (11)(ii)
for renewable CNG/LNG produced from a facility covered by a registration
accepted by EPA under Sec. 80.1450(b) prior to July 1, 2024.
(B) Biogas or RNG produced under a registration accepted by EPA
under Sec. 80.1450(b) for the generation of RINs as specified in Sec.
80.1426(f)(10)(ii) or (11)(ii) prior to July 1, 2024, may only be used
to generate RINs for renewable CNG/LNG.
[[Page 122]]
(ii) For biogas produced on or after January 1, 2025, biogas closed
distribution system RIN generators must generate RINs for renewable CNG/
LNG as specified in Sec. 80.130.
(5) Generation of RINs for renewable fuel produced from biogas used
as a biointermediate. Renewable fuel producers must only generate RINs
for renewable fuel produced from biogas used as a biointermediate
produced on or after July 1, 2024.
Sec. 80.105 Biogas producers.
(a) General requirements. (1) Any biogas producer that produces
biogas for use to produce RNG or a biogas-derived renewable fuel, or
that produces biogas used as a biointermediate, must comply with the
requirements of this section.
(2) The biogas producer must also comply with all other applicable
requirements of this part and 40 CFR part 1090.
(3) If the biogas producer meets the definition of more than one
type of regulated party under this part or 40 CFR part 1090, the biogas
producer must comply with the requirements applicable to each of those
types of regulated parties.
(4) The biogas producer must comply with all applicable requirements
of this part, regardless of whether the requirements are identified in
this section.
(b) Registration. The biogas producer must register with EPA under
Sec. Sec. 80.135, 80.1450, and 40 CFR part 1090, subpart I, as
applicable.
(c) Reporting. The biogas producer must submit reports to EPA under
Sec. Sec. 80.140 and 80.1451, as applicable.
(d) Recordkeeping. The biogas producer must create and maintain
records under Sec. Sec. 80.145 and 80.1454.
(e) PTDs. On each occasion when the biogas producer transfers title
of any biogas, the transferor must provide to the transferee PTDs under
Sec. 80.150.
(f) Sampling, testing, and measurement. (1) All sampling, testing,
and measurements must be done in accordance with Sec. 80.155.
(2)(i) A biogas producer must measure the volume of biogas, in Btu
HHV, prior to converting biogas to any of the following:
(A) RNG.
(B) Treated biogas.
(C) Biointermediate.
(D) Biogas-derived renewable fuel.
(E) Process heat or energy under Sec. 80.1426(f)(12) or (13).
(ii) Except for biogas produced from a mixed digester, a biogas
producer must measure the volume of biogas, in Btu HHV, for each batch
pathway prior to mixing with biogas produced under a different batch
pathway or with non-qualifying gas.
(iii) For biogas produced from a mixed digester, a biogas producer
must do all the following for each mixed digester:
(A) Measure the volume of biogas, in Btu HHV, prior to mixing with
any other gas.
(B) Measure the daily mass of the cellulosic biogas feedstock, in
pounds, added to the mixed digester.
(C) Collect a daily representative sample of each cellulosic biogas
feedstock and test for total solids and volatile solids as specified in
Sec. 80.155(c).
(D) Measure and calculate the digester operating conditions as
specified in Sec. 80.155(d).
(iv) A biogas producer must measure each volume of gas containing
biogas, in Btu HHV, that leaves the facility.
(g) Foreign biogas producer requirements. A foreign biogas producer
must meet all the requirements that apply to a biogas producer under
this part, as well as the additional requirements for foreign biogas
producers specified in Sec. 80.160.
(h) Attest engagements. The biogas producer must submit annual
attest engagement reports to EPA under Sec. Sec. 80.165 and 80.1464
using procedures specified in 40 CFR 1090.1800 and 1090.1805.
(i) QAP. Prior to the generation of Q-RINs for a biogas-derived
renewable fuel, the biogas producer must meet all applicable
requirements specified in Sec. 80.170.
(j) Batches. (1) Except for biogas produced from a mixed digester,
the batch volume of biogas is the volume of biogas measured under
paragraph (f) of this section for a single batch pathway at a single
facility for a calendar month, in Btu HHV.
[[Page 123]]
(2) For biogas produced from a mixed digester, the batch volume of
biogas must be calculated as follows:
(i) The batch volume of biogas produced under an approved pathway
with a D code of 5 must be calculated as follows:
VBG,D5 = VBG-VBG,D3/7
Where:
VBG,D5 = The batch volume of biogas for an approved
pathway with a D code of 5 for the calendar month, in Btu HHV. If the
result of this equation is negative, then VBG,D5,p equals 0.
VBG = The total volume of biogas produced by the mixed
digester for the calendar month, in Btu HHV, as measured under
paragraph (f)(2)(iii)(A) of this section.
VBG,D3/7 = The total batch volume of biogas produced under
approved pathways with a D code of 3 or 7 for the calendar
month, in Btu HHV, per paragraph (j)(2)(ii) of this section.
(ii) The batch volume of biogas produced under an approved pathway
with a D code of 3 or 7 must be calculated as follows:
VBG,D3/7,p = BED3/7,i
VBG,D3/7,p = The batch volume of biogas for batch pathway p
with a D code of 3 or 7 for the calendar month, in Btu HHV.
BED3/7,i = The total energy from cellulosic biogas feedstock
i that forms energy in the biogas and whose batch pathway has
been assigned a D code of 3 or 7 for the calendar month, in
Btu HHV, per paragraph (j)(2)(iii) of this section.
(iii) The biogas energy value for each cellulosic biogas feedstock
must be calculated as follows:
BED3/7,i,j = Mi,j * TSi,j *
VSi,j * CFi,j
Where:
BED3/7,i,j = The amount of energy from cellulosic biogas
feedstock i that forms energy in the biogas and whose batch
pathway has been assigned a D code of 3 or 7 on day j, in Btu
HHV.
Mi,j = Mass of cellulosic biogas feedstock i, in pounds,
measured on day j, per paragraph (f)(2)(iii)(B) of this
section.
TSi,j = Total solids of cellulosic biogas feedstock i, as a
mass fraction, in pounds total solids per pound feedstock, for
the sample obtained on day j, per paragraph (f)(2)(iii)(C) of
this section. If sample results are not available, then
TSi,j equals 0.
VSi,j = Volatile solids of cellulosic biogas feedstock i, as
a mass fraction, in pounds volatile solids per pound total
solids, for the sample obtained on day j, per paragraph
(f)(2)(iii)(C) of this section. If sample results are not
available, then VSi,j equals 0.
CFi,j = Converted fraction in annual average Btu HHV/lb,
representing the portion of cellulosic biogas feedstock i that
is converted to biomethane by the producer on day j, per
paragraph (j)(2)(iv) of this section. If data for digester
operating conditions required under paragraph (f)(2)(iii)(D)
of this section are outside the range of operating conditions
specified in paragraph (j)(2)(v) of this section or such data
to determine the operating conditions does not meet the
requirements in Sec. 80.155(d), then CFi,j equals
0.
(iv) Biogas producers must use one of the following cellulosic
conversion factors, as applicable:
(A) Swine manure: 1,936 Btu HHV/lb.
(B) Bovine manure: 2,077 Btu HHV/lb.
(C) Chicken manure: 3,001 Btu HHV/lb.
(D) Municipal wastewater treatment sludge: 3,479 Btu HHV/lb.
(E) A cellulosic conversion factor accepted at registration under
Sec. 80.135(c)(10)(vi).
(v) Applicable operating conditions for the cellulosic converted
fractions specified in paragraph (j)(2)(iv) of this section are the
following:
(A) For the cellulosic converted fraction values specified in
paragraphs (j)(2)(iv)(A) through (D) of this section, the mixed digester
must continuously operate above 95 degrees Fahrenheit with hydraulic and
solids mean residence times greater than 20 days.
(B) For the cellulosic converted fraction value specified in
paragraph (j)(2)(iv)(E) of this section, the mixed digester must operate
according to the conditions accepted at registration under Sec.
80.135(c)(10)(vi)(A)(4).
(3) The biogas producer must assign a number (the ``batch number'')
to each batch of biogas consisting of their EPA-issued company
registration number, the EPA-issued facility registration number, the
last two digits of the calendar year in which the batch was produced,
and a unique number for the batch, beginning with the number one for the
first batch produced each calendar year and each subsequent batch during
the calendar year being assigned the next sequential number (e.g., 4321-
54321-23-000001, 4321-54321-23-000002, etc.).
[[Page 124]]
(k) Limitations. (1) For each biogas production facility, the biogas
producer must only supply biogas for only one of the following uses:
(i) Production of renewable CNG/LNG via a biogas closed distribution
system.
(ii) As a biointermediate via a biogas closed distribution system.
(iii) Production of RNG.
(2) For each biogas production facility producing biogas for use as
a biointermediate in a biogas closed distribution system, the biogas
producer must only supply biogas or treated biogas to a single renewable
fuel production facility.
(3) If the biogas producer operates a municipal wastewater treatment
facility digester, the biogas producer must not introduce any feedstocks
into that digester that do not contain at least 75% average adjusted
cellulosic content.
(4) The transfer and batch segregation limits specified in Sec.
80.1476(g) do not apply.
Sec. 80.110 RNG producers, RNG importers, and biogas closed distribution
system RIN generators.
(a) General requirements. (1) Any RNG producer, RNG importer, or
biogas closed distribution system RIN generator that generates RINs must
comply with the requirements of this section.
(2) The RNG producer, RNG importer, or biogas closed distribution
system RIN generator must also comply with all other applicable
requirements of this part and 40 CFR part 1090.
(3) If the RNG producer, RNG importer, or biogas closed distribution
system RIN generator meets the definition of more than one type of
regulated party under this part or 40 CFR 1090, the RNG producer, RNG
importer, or biogas closed distribution system RIN generator must comply
with the requirements applicable to each of those types of regulated
parties.
(4) The RNG producer, RNG importer, or biogas closed distribution
system RIN generator must comply with all applicable requirements of
this part, regardless of whether the requirements are identified in this
section.
(5) The transfer and batch segregation limits specified in Sec.
80.1476(g) do not apply.
(b) Registration. The RNG producer, RNG importer, or biogas closed
distribution system RIN generator must register with EPA under
Sec. Sec. 80.135, 80.1450, and 40 CFR part 1090, subpart I, as
applicable.
(c) Reporting. The RNG producer, RNG importer, or biogas closed
distribution system RIN generator must submit reports to EPA under
Sec. Sec. 80.140, 80.1451, and 80.1452, as applicable.
(d) Recordkeeping. The RNG producer, RNG importer, or biogas closed
distribution system RIN generator must create and maintain records under
Sec. Sec. 80.145 and 80.1454.
(e) PTDs. On each occasion when the RNG producer, RNG importer, or
biogas closed distribution system RIN generator transfers RNG, renewable
fuel, or RINs to another party, the transferor must provide to the
transferee PTDs under Sec. Sec. 80.150 and 80.1453, as applicable.
(f) Sampling, testing, and measurement. (1) All sampling, testing,
and measurements must be done in accordance with Sec. 80.155.
(2)(i) An RNG producer must measure the volume of RNG, in Btu LHV,
prior to injection of RNG from the RNG production facility into a
natural gas commercial pipeline system.
(ii) An RNG producer that trucks RNG from the RNG production
facility to a pipeline interconnect must measure the volume of RNG, in
Btu LHV, upon loading and unloading of each truck.
(iii) An RNG producer that injects RNG from an RNG production
facility into a natural gas commercial pipeline system must sample and
test a representative sample of all the following at least once per
calendar year, as applicable:
(A) Biogas used to produce RNG.
(B) RNG before blending with non-renewable components.
(C) RNG after blending with non-renewable components.
(iv) A party that upgrades biogas to treated biogas must separately
measure all the following, as applicable:
(A) The volume of biogas, in Btu HHV, used to produce treated
biogas, a biogas-derived renewable fuel, or as a biointermediate.
[[Page 125]]
(B) The volume of treated biogas, in Btu HHV, prior to addition of
any non-renewable components.
(C) The volume of biointermediate or biogas-derived renewable fuel
produced from the biogas or treated biogas. If the biogas-derived
renewable fuel is renewable CNG/LNG, then this volume must be measured
in both Btu HHV and Btu LHV.
(3) A biogas closed distribution RIN generator must measure
renewable CNG/LNG in Btu LHV.
(g) Foreign RNG producer, RNG importer, and foreign biogas closed
distribution system RIN generator requirements. (1)(i) A foreign RNG
producer must meet all the requirements that apply to an RNG producer
under this part, as well as the additional requirements for foreign RNG
producers specified in Sec. 80.160.
(ii) A foreign RNG producer must either generate RINs under Sec.
80.125 or enter into a contract with an RNG importer as specified in
Sec. 80.160(e).
(2) An RNG importer must meet all the requirements specified in
Sec. 80.160(h).
(3) A foreign biogas closed distribution system RIN generator must
meet all the requirements that apply to a biogas closed distribution
system RIN generator under this part, as well as the additional
requirements for foreign biogas closed distribution system RIN
generators specified in Sec. 80.160 and for RIN-generating foreign
renewable fuel producers specified in Sec. 80.1466.
(h) Attest engagements. The RNG producer, RNG importer, or biogas
closed distribution system RIN generator must submit annual attest
engagement reports to EPA under Sec. Sec. 80.165 and 80.1464 using
procedures specified in 40 CFR 1090.1800 and 1090.1805.
(i) QAP. Prior to the generation of a Q-RIN for RNG or biogas-
derived renewable fuel, the RNG producer, RNG importer, or biogas closed
distribution system RIN generator must meet all applicable requirements
specified in Sec. 80.170.
(j) Batches. (1) A batch of RNG is the total volume of RNG produced
at an RNG production facility under a single batch pathway for the
calendar month, in Btu LHV, as determined under paragraph (j)(4) of this
section.
(2) A batch of biogas-derived renewable fuel must comply with the
requirements specified in Sec. 80.1426(d).
(3) The RNG producer, RNG importer, or biogas closed distribution
system RIN generator must assign a number (the ``batch number'') to each
batch of RNG or biogas-derived renewable fuel consisting of their EPA-
issued company registration number, the EPA-issued facility registration
number, the last two digits of the calendar year in which the batch was
produced, and a unique number for the batch, beginning with the number
one for the first batch produced each calendar year and each subsequent
batch during the calendar year being assigned the next sequential number
(e.g., 4321-54321-23-000001, 4321-54321-23-000002, etc.).
(4) The batch volume of RNG must be calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR12JY23.006
Where:
VRNG,p = The batch volume of RNG for batch pathway p, in Btu
LHV.
VNG = The total volume of natural gas produced at the RNG
production facility for the calendar month, in Btu LHV, as
measured under Sec. 80.155.
VBG,p = The total volume of biogas used to produce RNG under
batch pathway p for the calendar month, in Btu HHV, per Sec.
80.105(j).
VBG,total = The total volume of biogas used to produce RNG
under all batch pathways for the calendar month, in Btu HHV,
per Sec. 80.105(j).
R = The renewable fraction of the natural gas produced at the RNG
production facility for the calendar month. For natural gas
produced only from renewable feedstocks, R is equal to 1. For
natural gas produced from both renewable and non-renewable
feedstocks, R must be
[[Page 126]]
measured by a carbon-14 dating test method, per Sec.
80.1426(f)(9).
Sec. 80.115 RNG RIN separators.
(a) General requirements. (1) Any RNG RIN separator must comply with
the requirements of this section.
(2) The RNG RIN separator must also comply with all other applicable
requirements of this part and 40 CFR part 1090.
(3) If the RNG RIN separator meets the definition of more than one
type of regulated party under this part or 40 CFR 1090, the RNG RIN
separator must comply with the requirements applicable to each of those
types of regulated parties.
(4) The RNG RIN separator must comply with all applicable
requirements of this part, regardless of whether the requirements are
identified in this section.
(b) Registration. (1) The RNG RIN separator must register with EPA
under Sec. Sec. 80.135, 80.1450, and 40 CFR part 1090, subpart I, as
applicable.
(2) A dispensing location may only be included in one RNG RIN
separator's registration at a time.
(c) Reporting. The RNG RIN separator must submit reports to EPA
under Sec. Sec. 80.140, 80.1451, and 80.1452, as applicable.
(d) Recordkeeping. The RNG RIN separator must create and maintain
records under Sec. Sec. 80.145 and 80.1454.
(e) PTDs. On each occasion when the RNG RIN separator transfers
title of renewable fuel and RINs to another party, the transferor must
provide to the transferee PTDs under Sec. 80.1453.
(f) Measurement. (1) All measurements must be done in accordance
with Sec. 80.155.
(2) An RNG RIN separator must measure the volume of natural gas, in
Btu LHV, withdrawn from the natural gas commercial pipeline system.
(g) Attest engagements. The RNG RIN separator must submit annual
attest engagement reports to EPA under Sec. Sec. 80.165 and 80.1464
using procedures specified in 40 CFR 1090.1800 and 1090.1805.
Sec. 80.120 Parties that use biogas as a biointermediate or RNG as a
feedstock or as process heat or energy.
(a) General requirements. (1) Any renewable fuel producer that uses
biogas as a biointermediate or RNG as a feedstock or as process heat or
energy under Sec. 80.1426(f)(12) or (13) must comply with the
requirements of this section.
(2) The renewable fuel producer must also comply with all other
applicable requirements of this part and 40 CFR part 1090.
(3) If the renewable fuel producer meets the definition of more than
one type of regulated party under this part or 40 CFR 1090, the
renewable fuel producer must comply with the requirements applicable to
each of those types of regulated parties.
(4) The renewable fuel producer must comply with all applicable
requirements of this part, regardless of whether they are identified in
this section.
(5) The transfer and batch segregation limits specified in Sec.
80.1476(g) do not apply.
(b) Registration. The renewable fuel producer must register with EPA
under Sec. Sec. 80.135, 80.1450, and 40 CFR part 1090, subpart I, as
applicable.
(c) Reporting. The renewable fuel producer must submit reports to
EPA under Sec. Sec. 80.140, 80.1451, and 80.1452, as applicable.
(d) Recordkeeping. The renewable fuel producer must create and
maintain records under Sec. Sec. 80.145 and 80.1454.
(e) PTDs. On each occasion when the renewable fuel producer
transfers title of biogas-derived renewable fuel and RINs to another
party, the transferor must provide to the transferee PTDs under
Sec. Sec. 80.150 and 80.1453.
(f) Measurement. (1) All measurements must be done in accordance
with Sec. 80.155.
(2) A renewable fuel producer must measure the volume of natural
gas, in Btu LHV, withdrawn from the natural gas commercial pipeline
system.
(g) Attest engagements. The renewable fuel producer must submit
annual attest engagement reports to EPA under Sec. Sec. 80.165 and
80.1464 using procedures specified in 40 CFR 1090.1800 and 1090.1805.
[[Page 127]]
(h) QAP. Prior to the generation of a Q-RIN for biogas-derived
renewable fuel produced from biogas used as a biointermediate or RNG
used as a feedstock, the renewable fuel producer must meet all
applicable requirements specified in Sec. 80.170.
Sec. 80.125 RINs for RNG.
(a) General requirements. (1) Any party that generates, assigns,
transfers, receives, separates, or retires RINs for RNG must comply with
the requirements of this section.
(2) Any party that transacts RINs for RNG under this section must
transact the RINs as specified in Sec. 80.1452.
(b) RIN generation. (1) Only RNG producers may generate RINs for RNG
injected into a natural gas commercial pipeline system.
(2) RNG producers must generate RINs for only the biomethane content
of biogas supplied by a biogas producer registered under Sec. 80.135.
(3) RNG producers must generate RINs using the applicable
requirements for RIN generation in Sec. 80.1426.
(4) If non-renewable components are blended into RNG, the RNG
producer must generate RINs for only the biomethane content of the RNG
prior to blending.
(5) RNG producers must use the measurement procedures specified in
Sec. 80.155 to determine the heating value of RNG for the generation of
RINs.
(6) The number of RINs generated for a batch volume of RNG under
each batch pathway must be calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR12JY23.007
Where:
RINRNG,p = The number of RINs generated for a batch of RNG
under batch pathway p, in gallon-RINs.
VRNG,p = The batch volume of RNG for batch pathway p, in Btu
LHV, per Sec. 80.110(j)(4).
EqVRNG = The equivalence value for RNG, in Btu LHV per RIN,
per Sec. 80.1415(b)(5).
(7) When RNG is injected from multiple RNG production facilities at
a pipeline interconnect, the total number of RINs generated must not be
greater than the total number of RINs eligible to be generated under
Sec. 80.1415(b)(5) for the total volume of RNG injected by all RNG
production facilities at that pipeline interconnect.
(8) For RNG that is trucked prior to injection into a natural gas
commercial pipeline system, the total volume of RNG injected for the
calendar month, in Btu LHV, must not be greater than the lesser of the
total loading or unloading volume measurement for the month, in Btu LHV,
as required under Sec. 80.110(f)(2)(ii).
(9) Renewable fuel producers that retire RINs for RNG used as a
feedstock under paragraph (e) of this section may only generate RINs for
the renewable fuel produced from RNG if all applicable requirements
under this part are met.
(c) RIN assignment and transfer. (1) RNG producers must assign the
RINs generated for a batch of RNG to the specific volume of RNG injected
into the natural gas commercial pipeline system.
(2) Except as specified in paragraph (c)(1) of this section, no
party may assign a RIN to a volume of RNG.
(3) Each party that transfers title of a volume of RNG to another
party must transfer title of any assigned RINs for the volume of RNG to
the transferee.
(d) RIN separation. (1) Only the following parties may separate a
RIN from RNG:
(i) The party that withdrew the RNG from the natural gas commercial
pipeline system.
(ii) The party that produced or oversaw the production of the
renewable CNG/LNG from the RNG.
(iii) The party that used or dispensed for use the renewable CNG/LNG
as transportation fuel.
[[Page 128]]
(2) An RNG RIN separator must only separate a RIN from RNG if all
the following requirements are met:
(i) The RNG used to produce the renewable CNG/LNG was measured using
the procedures specified in Sec. 80.155.
(ii) The RNG RIN separator has the following documentation
demonstrating that the volume of renewable CNG/LNG was used as
transportation fuel:
(A) If the RNG RIN separator sold or used the renewable CNG/LNG,
records demonstrating the date, location, and volume of renewable CNG/
LNG sold or used as transportation fuel.
(B) If the RNG RIN separator is relying on documentation from
another party, all the following as applicable:
(1) A written contract with the other party for the sale or use of
the renewable CNG/LNG as transportation fuel.
(2) Records from the other party demonstrating the date, location,
and volume of renewable CNG/LNG sold or used as transportation fuel.
(3) An affidavit from each other party confirming all the following:
(i) That the volume of renewable CNG/LNG was used as transportation
fuel and for no other purpose.
(ii) That the party will not separate RINs for this volume of RNG.
(iii) That the party has not provided affidavits to any other party
for the purpose of complying with the requirements of this paragraph
(d)(2)(ii).
(iii) The volume of RNG was only used to produce renewable CNG/LNG
that is used as transportation fuel and for no other purpose.
(iv) No other party used the measurement information under paragraph
(d)(2)(i) of this section or the information required under paragraph
(d)(2)(ii) of this section to separate RINs for the RNG.
(v) No other party has separated RINs for the RNG using the same
dispensing location during the calendar month.
(vi) The RNG RIN separator follows the applicable provisions under
Sec. 80.1429(a), (b)(10), and (c) through (e).
(3) An obligated party must not separate RINs for RNG under Sec.
80.1429(b)(1) unless the obligated party meets the requirements in
paragraph (d)(1) of this section.
(4) A party must only separate a number of RINs equal to the total
volume of RNG (where the Btu LHV are converted to gallon-RINs using the
conversion specified in Sec. 80.1415(b)(5)) that the party demonstrates
is used as renewable CNG/LNG under paragraph (d)(2) of this section.
(e) RIN retirement. (1) A party must retire RINs generated for RNG
if any of the conditions specified in Sec. 80.1434(a) apply and must
comply with Sec. 80.1434(b).
(2)(i) A party must retire all assigned RINs for a volume of RNG if
the RINs are not separated under paragraph (d) of this section by the
date the assigned RINs expire under Sec. 80.1428(c).
(ii) A party must retire any expired RINs under paragraph (e)(2)(i)
of this section by March 31 of the subsequent year. For example, if an
RNG producer assigns RINs for RNG in 2025, the RINs expire if they are
not separated under paragraph (d) of this section by December 31, 2026,
and must be retired by March 31, 2027.
(3) A party that uses RNG for a purpose other than to produce
renewable CNG/LNG (e.g., as a feedstock, as process heat under Sec.
80.1426(f)(12), or as process energy under Sec. 80.1426(f)(13)) must
retire any assigned RINs for the volume of RNG within 5 business days of
such use of the RNG.
Sec. 80.130 RINs for renewable CNG/LNG from a biogas closed distribution
system.
(a) General requirements. (1) Any party that generates, assigns,
separates, or retires RINs for renewable CNG/LNG from a biogas closed
distribution system must comply with the requirements of this section.
(2) Parties must report all RIN transactions to EMTS as specified in
Sec. 80.1452.
(b) RIN generation. (1) Biogas closed distribution system RIN
generators must generate RINs using the applicable requirements for RIN
generation in under this part.
(2) RINs for renewable CNG/LNG from a biogas closed distribution
system may be generated if all the following requirements are met:
(i) The renewable CNG/LNG is produced from renewable biomass and
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qualifies to generate RINs under an approved pathway.
(ii) The biogas closed distribution system RIN generator has entered
into a written contract for the sale or use of a specific quantity of
renewable CNG/LNG for use as transportation fuel, and has obtained
affidavits from all parties selling or using the renewable CNG/LNG
certifying that the renewable CNG/LNG was used as transportation fuel.
(iii) The renewable CNG/LNG is used as transportation fuel and for
no other purpose.
(c) RIN separation. A biogas closed distribution system RIN
generator must separate RINs generated for renewable CNG/LNG under Sec.
80.1429(b)(5)(ii).
(d) RIN retirement. A party must retire RINs generated for renewable
CNG/LNG from a biogas closed distribution if any of the conditions
specified in Sec. 80.1434(a) apply and must comply with Sec.
80.1434(b).
Sec. 80.135 Registration.
(a) Applicability. The following parties must register using the
procedures specified in this section, Sec. 80.1450 and 40 CFR 1090.800:
(1) Biogas producers.
(2) RNG producers.
(3) RNG importers.
(4) Biogas closed distribution system RIN generators.
(5) RNG RIN separators.
(6) Renewable fuel producers using biogas as a biointermediate or
RNG as a feedstock.
(b) General registration requirements. Parties must submit
applicable information for companies and facilities as specified in 40
CFR 1090.805.
(1) New registrants. (i) Parties required to register under this
subpart must have an EPA-accepted registration prior to engaging in
regulated activities under this subpart.
(ii) Registration information must be submitted at least 60 days
prior to engaging in regulated activities under this subpart.
(iii) Parties may engage in regulated activities under this subpart
once EPA has accepted their registration and they have met all other
applicable requirements under this subpart.
(2) Existing renewable CNG/LNG registrations. (i) Parties listed in
paragraph (a) of this section must submit updated registration
information that complies with the applicable requirements of this
section for any company or facility covered by a registration accepted
under Sec. 80.1450(b) for the generation of RINs under Sec.
80.1426(f)(10)(ii) or (11)(ii) no later than October 1, 2024.
(ii) A biogas closed distribution system RIN generator or biogas
producer does not need to submit an updated engineering review for any
facility in the biogas closed distribution system as specified in Sec.
80.1450(d)(1) before the next three-year engineering review update is
due as specified in Sec. 80.1450(d)(3).
(3) Engineering reviews. (i) Any party required to register a
facility under this section must undergo all the following:
(A) A third-party engineering review as specified in Sec.
80.1450(b)(2).
(B) Three-year engineering review updates as specified in Sec.
80.1450(d)(3).
(ii) Third-party engineering reviews and three-year engineering
review updates required under paragraph (b)(3)(i) of this section must
evaluate all applicable registration information submitted under this
section as well as all applicable requirements in Sec. 80.1450(b).
(iii) A party may arrange for an independent third-party engineer to
conduct a single site visit and submit a single engineering review
report for a facility that performs multiple activities (e.g., a
facility that both produces biogas and upgrades it to RNG) under this
subpart as long as the site visit and engineering review report includes
all the requirements for each activity performed.
(4) Registration updates. (i) Parties registered under this section
must submit updated registration information to EPA within 30 days when
any of the following occur:
(A) The registration information previously supplied becomes
incomplete or inaccurate.
(B) Facility information is updated under Sec. 80.1450(d)(1), as
applicable.
(C) A change of ownership is submitted under 40 CFR 1090.820.
(ii) Parties registered under this section must submit updated
registration information to EPA within 7 days when
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any facility information is updated under Sec. 80.1450(d)(2).
(iii) Parties that register a facility under this section must
update their registration information and undergo a three-year
engineering review update as specified in Sec. 80.1450(d)(3).
(5) Registration deactivations. EPA may deactivate the registration
of a party registered under this section as specified in Sec.
80.1450(h), 40 CFR 1090.810, or 40 CFR 1090.815, as applicable.
(c) Biogas producer. In addition to the information required under
paragraph (b) of this section, a biogas producer must submit all the
following information for each biogas production facility:
(1) Information describing the biogas production capacity for the
biogas production facility, in Btu HHV, including the following:
(i) Information regarding the permitted capacity in the most recent
applicable air permits issued by EPA, a state, a local air pollution
control agency, or a foreign governmental agency that governs the biogas
production facility, if available.
(ii) Documents demonstrating the biogas production facility's
nameplate capacity.
(iii) Information describing the biogas production facility's biogas
production for each of the last three calendar years prior to the
registration submission, if available.
(2) Whether the biogas will be used to produce RNG, renewable CNG/
LNG, or biointermediate and information identifying the facility that
will be supplied.
(3) The following information related to biogas measurement:
(i) A description of how biogas will be measured under Sec.
80.155(a), including the specific standards under which the meters are
operated.
(ii) A description of the biogas production process, including a
process flow diagram that includes metering type(s) and location(s).
(iii) For an alternative measurement protocol under Sec.
80.155(a)(3), all the following:
(A) A description of why the biogas producer is unable to use meters
that comply with the requirements specified in Sec. 80.155(a)(1) and
(2), as applicable.
(B) A description of how measurement is conducted.
(C) Any standards or specifications that apply.
(D) A description of all routine maintenance and the frequency that
such maintenance will be conducted.
(E) A description of the frequency of all measurements and how often
such measurements will be recorded under the alternative measurement
protocol.
(F) A comparison between the accuracy, precision, and reliability of
the alternative measurement protocol and the requirements specified in
Sec. 80.155(a)(1) and (2), as applicable, including any supporting
data.
(4) For biogas used to produce renewable CNG/LNG in a biogas closed
distribution system, all the following additional information:
(i) A process flow diagram of each step of the physical process from
feedstock entry to the point where the renewable CNG/LNG is dispensed as
transportation fuel. This includes all the following:
(A) Feedstock processing.
(B) Biogas production.
(C) Biogas processing.
(D) Renewable CNG/LNG production.
(E) Points where non-renewable natural gas may be added.
(F) Dispensing stations.
(G) Measurement locations and equipment.
(H) Major equipment (e.g., tanks, pipelines, flares, separation
equipment, compressors, and dispensing infrastructure).
(I) Any other process-related information as requested by EPA.
(ii) A description of losses of heating content going from biogas to
renewable CNG/LNG and an explanation of how such losses would be
accounted for.
(iii) A description of the physical process from biogas production
to dispensing of renewable CNG/LNG as transportation fuel, including the
biogas closed distribution system.
(iv) A description of the vehicle fleet and dispensing stations that
are expected to use and distribute the renewable CNG/LNG as
transportation fuel.
(5) For biogas used as a biointermediate, all the information
specified in Sec. 80.1450(b)(1)(ii)(B).
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(6) For biogas used to produce RNG, all the following additional
information:
(i) The RNG producer that will upgrade the biogas.
(ii) A process flow diagram of the physical process from biogas
production to entering the RNG production facility, including major
equipment (e.g., tanks, pipelines, flares, separation equipment).
(iii) A description of the physical process from biogas production
to entering the RNG production facility, including an explanation of how
the biogas reaches the RNG production facility.
(7) For biogas produced in an agricultural digester, all the
following information:
(i) A separated yard waste plan specified in Sec.
80.1450(b)(1)(vii)(A), as applicable.
(ii) Crop residue information specified in Sec. 80.1450(b)(1)(xv),
as applicable.
(iii) A process flow diagram of the physical process from feedstock
entry to biogas production, including major equipment (e.g., feedstock
preprocessing equipment, tanks, digesters, pipelines, flares).
(8) For biogas produced in a municipal wastewater treatment facility
digester, a process flow diagram of the physical process from feedstock
entry to biogas production, including major equipment (e.g., feedstock
preprocessing equipment, tanks, digesters, pipelines, flares).
(9) For biogas produced in a separated MSW digester, all the
following information:
(i) Separated MSW plan specified in Sec. 80.1450(b)(1)(viii).
(ii) A process flow diagram of the physical process from feedstock
entry to biogas production, including major equipment (e.g., feedstock
preprocessing equipment, tanks, digesters, pipelines, flares).
(10) For biogas produced in other waste digesters, all the following
information, as applicable:
(i) A separated MSW plan specified in Sec. 80.1450(b)(1)(viii).
(ii) A separated yard waste plan specified in Sec.
80.1450(b)(1)(vii)(A).
(iii) Crop residues information specified in Sec.
80.1450(b)(1)(xv).
(iv) A separated food waste plan or biogenic waste oils/fats/greases
plan specified in Sec. 80.1450(b)(1)(vii)(B).
(v) A process flow diagram of each step of the physical process from
feedstock entry to the point where the biogas either leaves the facility
or is used to produce RNG, biointermediate, or biogas-derived renewable
fuel. This includes all the following:
(A) Feedstock processing.
(B) Biogas production.
(C) Biogas processing.
(D) Major equipment (e.g., feedstock preprocessing equipment, tanks,
digesters, pipelines, flares).
(E) Measurement locations and equipment.
(F) Any other process-related information as requested by EPA.
(vi) For biogas produced in a mixed digester, all the following:
(A) For biogas producers using a value under Sec.
80.105(j)(2)(iv)(E), all the following:
(1) The cellulosic converted fraction (CF) for each cellulosic
biogas feedstock that will be used in Sec. 80.105(j)(2)(iii), in Btu
HHV/lb feedstock, rounded to the nearest whole number.
(2) Data supporting the cellulosic CF from each cellulosic biogas
feedstock. Data must be derived from processing of cellulosic biogas
feedstock(s) in anaerobic digesters without simultaneous conversion
under similar conditions as will be run in the simultaneously converted
process. Data must be either from the facility when it was processing
solely the feedstock that does have a minimum 75% adjusted cellulosic
content or from a representative sample of other representative
facilities processing the feedstock that does have a minimum 75%
adjusted cellulosic content.
(3) A description of how the cellulosic CF was determined, including
any calculations demonstrating how the data were used.
(4) A list of ranges of processing conditions, including
temperature, solids mean residence time, and hydraulic mean residence
time, for which the cellulosic CF is accurate and a description of how
such processing conditions will be measured by the facility.
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(5) A demonstration that no biogas generated from non-cellulosic
biogas feedstocks could be used to generate RINs for a batch of
renewable fuel with a D code of 3 or 7. EPA may reject this
demonstration if it is not sufficiently protective.
(B) A description of the meters used to determine the mass of
cellulosic biogas feedstock.
(C) The location of feedstock sampling, additive (e.g., water)
addition, and mass measurement for use in Sec. 80.105(j)(2)(iii)
included in the process flow diagram required under paragraph (c)(10)(v)
of this section.
(D) For facilities using composite sampling under Sec.
80.155(c)(3), a composite sampling plan, including all the following:
(1) A description of when and where the samples will be collected.
(2) A description of how the samples will be stored prior to
testing.
(3) A description of how daily representative samples will be mixed,
including how the ratio of each sample will be determined.
(4) A description of how often testing will occur.
(5) A description of how the plan complies with Sec. 80.155(c)(2).
(d) RNG producer. In addition to the information required under
paragraph (b) of this section, an RNG producer must submit all the
following information for each RNG production facility:
(1) All applicable information in Sec. 80.1450(b)(1)(ii).
(2) Information to establish the RNG production capacity for the RNG
production facility, in Btu LHV, including all the following, as
applicable:
(i) Information regarding the permitted capacity in the most recent
applicable air permits issued by EPA, a state, a local air pollution
control agency, or a foreign governmental agency that governs the RNG
production facility, if available.
(ii) Documents demonstrating the RNG production facility's nameplate
capacity.
(iii) Information describing the RNG production facility's RNG
production for each of the last three calendar years prior to the
registration submission, if available.
(3) The following information related to RNG measurement:
(i) A description of how RNG will be measured under Sec. 80.155(a),
including the specific standards under which the meters are operated.
(ii) A description of the RNG production process, including a
process flow diagram that includes metering type(s) and location(s).
(iii) For an alternative measurement protocol under Sec.
80.155(a)(3), all the following:
(A) A description of why the RNG producer is unable to use meters
that comply with the requirements specified in Sec. 80.155(a)(1) and
(2), as applicable.
(B) A description of how measurement is conducted.
(C) Any standards or specifications that apply.
(D) A description of all routine maintenance and the frequency that
such maintenance will be conducted.
(E) A description of the frequency of all measurements and how often
such measurements will be recorded under the alternative measurement
protocol.
(F) A comparison between the accuracy, precision, and reliability of
the alternative measurement protocol and the requirements specified in
Sec. 80.155(a)(1) and (2), as applicable, including any supporting
data.
(4) The natural gas commercial pipeline system name and pipeline
interconnect location into which the RNG will be injected.
(5) A description of the natural gas specifications for the natural
gas commercial pipeline system into which the RNG will be injected,
including information on all parameters regulated by the pipeline (e.g.,
hydrogen sulfide, total sulfur, carbon dioxide, oxygen, nitrogen,
heating content, moisture, siloxanes, and any other available data
related to the gas components).
(6) For three-year registration updates, information related to RNG
quality, including all the following:
(i) A certificate of analysis--including the major and minor gas
components--from an independent laboratory for a representative sample
of the biogas produced at the biogas production facility as specified in
Sec. 80.155(b).
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(ii) A certificate of analysis--including the major and minor gas
components--from an independent laboratory for a representative sample
of the RNG prior to addition of non-renewable components as specified in
Sec. 80.155(b).
(iii) If the RNG is blended with non-renewable components prior to
injection into a natural gas commercial pipeline system, a certificate
of analysis from an independent laboratory for a representative sample
of the RNG after blending with non-renewable components as specified in
Sec. 80.155(b).
(iv) A summary table with the results of the certificates of
analysis required under paragraphs (d)(6)(i) through (iii) of this
section and the natural gas specifications required under paragraph
(d)(5) of this section converted to the same units.
(v) EPA may approve an RNG producer's request of an alternative
analysis in lieu of the certificates of analysis and summary table
required under paragraphs (d)(6)(i) through (iv) of this section if the
RNG producer demonstrates that the alternative analysis provides
information that is equivalent to that provided in the certificates of
analysis and that the RNG will meet all natural gas specifications
required under paragraph (d)(5) of this section.
(7) A RIN generation protocol that includes all the following
information:
(i) The procedure for allocating RNG injected into the natural gas
commercial pipeline system to each RNG production facility and each
biogas production facility, including how discrepancies in meter values
will be handled.
(ii) A diagram showing the locations of flow meters, gas analyzers,
and in-line GC meters used in the allocation procedure.
(iii) A description of when RINs will be generated (e.g., receipt of
monthly pipeline statement, etc).
(8) For an RNG production facility that injects RNG at a pipeline
interconnect that also has RNG injected from other sources, a
description of how the RNG producers will allocate RINs to ensure that
all facilities comply with the requirements specified in Sec.
80.125(b)(7).
(9) For a foreign RNG producer, all the following additional
information:
(i) The applicable information specified in Sec. 80.160.
(ii) Whether the foreign RNG producer will generate RINs for their
RNG.
(iii) For non-RIN generating foreign RNG producers, the name and
EPA-issued company and facility IDs of the contracted importer under
Sec. 80.160(e).
(e) RNG importer. In addition to the information required under
paragraph (b) of this section, an RNG importer must submit all the
following information:
(1) The name and EPA-issued company and facility IDs of the
contracted non-RIN generating foreign RNG producer under Sec.
80.160(e).
(2) The name and contact information for the independent third party
specified in Sec. 80.160(h).
(f) RNG RIN separator. In addition to the information required under
paragraph (b) of this section, an RNG RIN separator must submit a list
of locations of any dispensing stations where the RNG RIN separator
supplies or intends to supply renewable CNG/LNG for use as
transportation fuel.
(g) Renewable fuel producer using biogas as a biointermediate. In
addition to the information required under paragraph (b) of this
section, a renewable fuel producer using biogas as a biointermediate
must submit all the following:
(1) All applicable information in Sec. 80.1450(b).
(2) Documentation demonstrating a direct connection between the
biogas production facility and the renewable fuel production facility.
Sec. 80.140 Reporting.
(a) General provisions--(1) Applicability. Parties must submit
reports to EPA according to the schedule and containing all applicable
information specified in this section.
(2) Forms and procedures for report submission. All reports required
under this section must be submitted using forms and procedures
specified by EPA.
(3) Additional reporting elements. In addition to any applicable
reporting requirement under this section, parties must submit any
additional information EPA requires to administer the reporting
requirements of this section.
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(4) English language reports. All reported information submitted to
EPA under this section must be submitted in English, or must include an
English translation.
(5) Signature of reports. Reports required under this section must
be signed and certified as meeting all the applicable requirements of
this subpart by the RCO or their delegate identified in the company
registration under 40 CFR 1090.805(a)(1)(iv).
(6) Report submission deadlines. Reports required under this section
must be submitted by the following deadlines:
(i) Monthly reports must be submitted by the applicable monthly
deadline in Sec. 80.1451(f)(4).
(ii) Quarterly reports must be submitted by the applicable quarterly
deadline in Sec. 80.1451(f)(2).
(iii) Annual reports must be submitted by the applicable annual
deadline in Sec. 80.1451(f)(1).
(7) Volume standardization. (i) All volumes reported to EPA in scf
under this section must be standardized to STP.
(ii) All volumes reported to EPA in Btu under this section must be
converted according to Sec. 80.155(f), if applicable.
(iii) All other volumes reported to EPA under this section must be
standardized according to Sec. 80.1426(f)(8).
(b) Biogas producers. A biogas producer must submit monthly reports
to EPA containing all the following information for each batch of
biogas:
(1) Batch number.
(2) Production date (end date of the calendar month).
(3) Verification status of the batch.
(4) The batch volume of biogas supplied to the downstream party, in
Btu HHV and scf, as measured under Sec. 80.155.
(5) The associated pathway information, including D code, designated
use of the biogas (e.g., biointermediate, renewable CNG/LNG, or RNG),
and feedstock information.
(6) The EPA-issued company and facility IDs for the RNG producer,
biogas closed distribution system RIN generator, or renewable fuel
producer that received the batch of the biogas.
(c) RNG producers. (1) An RNG producer must submit quarterly reports
to EPA containing all the following information:
(i) The total volume of RNG, in Btu LHV and scf, produced and
injected into the natural gas commercial pipeline system as measured
under Sec. 80.155.
(ii) The total volume of non-renewable components, in Btu LHV, added
to RNG prior to injection into the natural gas commercial pipeline
system.
(2) A non-RIN generating foreign RNG producer must submit monthly
reports to EPA containing all the following information for each batch
of RNG:
(i) Batch number.
(ii) Production date (end date of the calendar month).
(iii) Verification status of the batch.
(iv) The associated pathway information, including D code,
production process, and feedstock information.
(v) The EPA-issued company and facility IDs for the RNG importer
that will generate RINs for the batch.
(d) Biogas closed distribution system RIN generators. A biogas
closed distribution system RIN generator must submit monthly reports to
EPA containing all the following information:
(1)(i) For fuels that are gaseous at STP, the type and volume of
biogas-derived renewable fuel, in Btu LHV.
(ii) For all other fuels, the type and volume of biogas-derived
renewable fuel, in gallons.
(2) Each of the following, as applicable, as measured under Sec.
80.155:
(i) The volume of biogas, in Btu HHV, used to produce the treated
biogas that is used to produce the biogas-derived renewable fuel.
(ii) The volume of biogas, in Btu HHV, used to produce the biogas-
derived renewable fuel.
(iii) The volume of treated biogas, in Btu HHV, used to produce the
biogas-derived renewable fuel.
(3) The name(s) and location(s) of where the biogas-derived
renewable fuel is used or sold for use as transportation fuel.
(4)(i) For fuels that are gaseous at STP, the volume of biogas-
derived renewable fuel, in Btu LHV, used at each location where the
biogas-derived renewable fuel is used or sold for use as transportation
fuel.
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(ii) For all other fuels, the volume of biogas-derived renewable
fuel, in gallons, used at each location where the biogas-derived
renewable fuel is used or sold for use as transportation fuel.
(5) All applicable information in Sec. 80.1451(b).
(e) RNG RIN separators. (1) An RNG RIN separator must submit
quarterly reports to EPA containing all the following information:
(i) Name and location of each point where RNG was withdrawn from the
natural gas commercial pipeline system.
(ii) Volume of RNG, in Btu LHV, withdrawn from the natural gas
commercial pipeline system during the reporting period by withdrawal
location.
(iii) Volume of renewable CNG/LNG, in Btu LHV, dispensed during the
reporting period by withdrawal location.
(2) An RNG RIN separator must submit monthly reports to EPA
containing all the following information for each batch of biogas:
(i) The location where renewable CNG/LNG was dispensed as
transportation fuel.
(ii) The volume of renewable CNG/LNG, in Btu LHV, dispensed as
transportation fuel at the location.
(f) Retirement of RINs for RNG used as a feedstock or process heat.
A party that retires RINs for RNG used as a feedstock or as process heat
or energy under Sec. 80.1426(f)(12) or (13) must submit quarterly
reports to EPA containing all the following information:
(1) The name(s) and location(s) of the natural gas commercial
pipeline where the RNG was withdrawn.
(2) Volume of RNG, in Btu LHV, withdrawn from the natural gas
commercial pipeline during the reporting period by location.
(3) The EPA-issued company and facility IDs for the facility that
used the withdrawn RNG as a feedstock or as process heat.
(4) For each facility, the following information, as applicable:
(i) For fuels that are gaseous at STP, the volume of biogas-derived
renewable fuel, in Btu LHV, produced using the withdrawn RNG.
(ii) For all other fuels, the volume of biogas-derived renewable
fuel, in gallons, produced using the withdrawn RNG.
(5) The number of RINs for RNG retired during the reporting period
by D code and verification status.
[88 FR 44564, July 12, 2023; 88 FR 51239, Aug. 3, 2023]
Sec. 80.145 Recordkeeping.
(a) General requirements--(1) Records to be kept. All parties
subject to the requirements of this subpart must keep the following
records:
(i) Compliance report records. Records related to compliance reports
submitted to EPA under this part as follows:
(A) Copies of all reports submitted to EPA.
(B) Copies of any confirmation received from the submission of such
reports to EPA.
(C) Copies of all underlying information and documentation used to
prepare and submit the reports.
(D) Copies of all calculations required under this subpart.
(ii) Registration records. Records related to registration under
this part and 40 CFR part 1090, subpart I, as follows:
(A) Copies of all registration information and documentation
submitted to EPA.
(B) Copies of all underlying information and documentation used to
prepare and submit the registration request.
(iii) PTD records. Copies of all PTDs required under this part.
(iv) Subpart M records. Any applicable record required under 40 CFR
part 80, subpart M.
(v) QAP records. Information and documentation related to
participation in any QAP program, including contracts between the entity
and the QAP provider, records related to verification activities under
the QAP, and copies of any QAP-related submissions.
(vi) Sampling, testing, and measurement records. Documents
supporting the sampling, storage, testing, and measurement results
relied upon under Sec. 80.155, including all results, maintenance
records, and calibration records.
(vii) Other records. Any other records relied upon by the party to
demonstrate compliance with this subpart.
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(viii) Potentially invalid RINs. Any records and copies of
notifications related to potentially inaccurate or non-qualifying biogas
volumes or potentially invalid RINs under Sec. 80.185.
(ix) RNG importers and foreign parties. Any records related to RNG
importers and foreign parties under Sec. Sec. 80.160, 80.1466, and
80.1467, as applicable.
(2) Length of time records must be kept. The records required under
this subpart must be kept for five years from the date they were
created, except that records related to transactions involving RINs must
be kept for five years from the date of the RIN transaction.
(3) Make records available to EPA. Any party required to keep
records under this section must make records available to EPA upon
request by EPA. For records that are electronically generated or
maintained, the party must make available any equipment and software
necessary to read the records or, upon approval by EPA, convert the
electronic records to paper documents.
(4) English language records. Any record requested by EPA under this
section must be submitted in English, or include an English translation.
(b) Biogas producers. In addition to the records required under
paragraph (a) of this section, a biogas producer must keep all the
following records:
(1) Copies of all contracts, PTDs, affidavits required under this
part, and all other commercial documents with any RNG producer,
biointermediate producer, or renewable fuel producer.
(2) Documents supporting the volume of biogas, in Btu HHV and scf,
produced for each batch.
(3) Documents supporting the composition and cleanup of biogas
produced for each batch (e.g., meter readings of composition, records of
adsorbent replacement, records showing equipment operation including
maintenance and energy usage, and records of component streams separated
from the biomethane-enriched stream).
(4) Information and documentation related to participation in any
QAP program, including contracts between the biogas producer and the QAP
provider, records related to verification activities under the QAP, and
copies of any QAP-related submissions.
(5) Records related to measurement, including types of equipment
used, metering process, maintenance and calibration records, documents
supporting adjustments related to error correction, and measurement
data.
(6) Documents supporting the use of each process heat source and
supporting the amount of each source used in the production process for
each batch.
(7) All the applicable recordkeeping requirements for digester
feedstocks under Sec. 80.1454.
(8) The following information and documents showing that the biogas
came from renewable biomass:
(i) For all anaerobic digesters, documentation showing the mass of
each feedstock type input into the digester for each batch of biogas.
(ii) For agricultural digesters, a quarterly affidavit signed by the
RCO or their delegate that only animal manure, crop residue, or
separated yard waste that had an adjusted cellulosic content of at least
75% were used to produce biogas during the quarter.
(iii) For municipal wastewater treatment facility digesters and
separated MSW digesters, a quarterly affidavit signed by the RCO or
their delegate that only feedstocks that had an adjusted cellulosic
content of at least 75% were used to produce biogas during the quarter.
(iv) For biogas produced from separated yard waste, separated food
waste, or biogenic waste oils/fats/greases, documents required under
Sec. 80.1454(j)(1).
(v) For biogas produced from separated MSW, documents required under
Sec. 80.1454(j)(2).
(9) For biogas produced in a mixed digester, all the following:
(i) Documents for each delivery of feedstock to the biogas
production facility, demonstrating all the following for each unique
combination of feedstock supplier and type of feedstock:
(A) The name of the feedstock supplier.
(B) The type of feedstock.
(C) The mass of that feedstock delivered from that supplier.
(ii) Data, documents, and calculations related to digester operating
conditions required under Sec. 80.105(f)(2)(iii)(D).
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(iii) Documents for each batch showing how measurement data for
volatile solids, total solids, and mass were used to calculate batch
volume under Sec. 80.105(j)(2).
(iv) Documents showing the amounts of additives (e.g., water),
timing of additive addition, and location of additive addition for all
additives added to the feedstock.
(v) For samples tested for volatile solids and total solids,
documents showing the time and location that each sample was obtained
and tested.
(c) RNG producers. In addition to the records required under
paragraph (a) of this section, an RNG producer must keep all the
following records:
(1) Records related to the generation and assignment of RINs,
including all the following information:
(i) Batch volume.
(ii) Batch number.
(iii) Production date when RINs were assigned to RNG.
(iv) Injection point into the natural gas commercial pipeline
system.
(v) Volume of biogas, in Btu HHV and scf, respectively, received at
each RNG production facility.
(vi) Volume of RNG, in Btu LHV, Btu HHV, and scf, produced at each
RNG production facility.
(vii) Pipeline injection statements describing the energy and volume
of natural gas for each pipeline interconnect.
(2) Records related to each RIN transaction, separately for each
transaction, including all the following information:
(i) A list of the RINs generated, owned, purchased, sold, separated,
retired, or reinstated.
(ii) The parties involved in each transaction including the
transferor, transferee, and any broker or agent.
(iii) The date of the transfer of the RINs.
(iv) Additional information related to details of the transaction
and its terms.
(3) Documentation recording the transfer and sale of RNG, from the
point of biogas production to the facility that sells or uses the fuel
for transportation purposes.
(4) A copy of the RNG producer's Compliance Certification required
under Title V of the Clean Air Act.
(5) Results of any laboratory analysis of chemical composition or
physical properties.
(6) Documents supporting the composition of biogas and RNG and
cleanup of biogas for each batch (e.g., meter readings of composition,
records of adsorbent replacement, records showing equipment operation
including maintenance and energy usage, and records of component streams
separated from the biomethane-enriched stream).
(7) Documents supporting the use of each process heat source and
supporting the amount of each source used in the production process for
each batch.
(8) Records related to measurement, including types of equipment
used, metering process, maintenance and calibration records, documents
supporting adjustments related to error correction, and measurement
data.
(9) Information and documentation related to participation in any
QAP program, including contracts between the RNG producer and the QAP
provider, records related to verification activities under the QAP, and
copies of any QAP-related submissions.
(10) For an RNG production facility that injects RNG at a pipeline
interconnect that also has RNG injected from other sources, documents
showing that RINs generated for the facility comply with the
requirements specified in Sec. 80.125(b)(7).
(11) Documentation of any waiver provided by the natural gas
commercial pipeline system for any parameter of the RNG that does not
meet the natural gas specifications submitted under Sec. 80.135(d)(5).
(d) Biogas closed distribution system RIN generators. In addition to
the records required under paragraph (a) of this section, a biogas
closed distribution system RIN generator must keep all the following
records:
(1) Documentation demonstrating that the renewable CNG/LNG was
produced from renewable biomass and qualifies to generate RINs under an
approved pathway.
(2) Copies of any written contract for the sale or use of renewable
CNG/LNG
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as transportation fuel, and copies of any affidavit from a party that
sold or used the renewable CNG/LNG as transportation fuel.
(e) RNG RIN separators. In addition to the records required under
paragraph (a) of this section, an RNG RIN separator must keep all the
following records:
(1) Documentation indicating the volume of RNG, in Btu LHV,
withdrawn from each interconnect of the natural gas commercial pipeline
system.
(2) Documentation demonstrating the volume of RNG, in Btu LHV,
withdrawn from the natural gas commercial pipeline system that was used
to produce renewable CNG/LNG.
(3) Documentation indicating the volume of renewable CNG/LNG, in Btu
LHV, dispensed as transportation fuel from each dispensing location.
(4) Copies of all documentation required under Sec.
80.125(d)(2)(ii), as applicable.
(5) Documentation showing how the number of RINs separated was
determined using the information specified in paragraphs (e)(1) through
(4) of this section and the applicable RIN separation reports.
(f) Renewable fuel producers that use biogas as a biointermediate or
RNG as a feedstock. In addition to the records required under paragraph
(a) of this section, a renewable fuel producer that uses biogas as a
biointermediate or RNG as a feedstock must keep all the following
records:
(1) Documentation supporting the volume of renewable fuel produced
from biogas used as a biointermediate or RNG that was used as a
feedstock.
(2) For biogas, all the following additional information:
(i) For each facility, documentation supporting the volume of
biogas, in Btu HHV and scf, that was used as a biointermediate.
(ii) Copies of all applicable contracts over the past 5 years with
each biointermediate producer.
(3) For RNG, all the following additional information:
(i) Documentation supporting the volume of RNG, in Btu LHV,
withdrawn from the natural gas commercial pipeline system.
(ii) Documentation supporting the retirement of RINs for RNG used as
a feedstock (e.g., contracts, purchase orders, invoices).
Sec. 80.150 Product transfer documents.
(a) General requirements--(1) PTD contents. On each occasion when
any person transfers title of any biogas or imported RNG without
assigned RINs, the transferor must provide the transferee PTDs that
include all the following information:
(i) The name, EPA-issued company and facility IDs, and address of
the transferor.
(ii) The name, EPA-issued company and facility IDs, and address of
the transferee.
(iii) The volume (in Btu HHV for biogas or Btu LHV for RNG) of the
product being transferred by D code and verification status.
(iv) The location of the product at the time of the transfer.
(v) The date of the transfer.
(vi) Period of production.
(2) Other PTD requirements. A party must also include any applicable
PTD information required under Sec. 80.1453 or 40 CFR part 1090,
subpart L.
(b) Additional PTD requirements for transfers of biogas. In addition
to the information required in paragraph (a) of this section, on each
occasion when any person transfers title of biogas, the transferor must
provide the transferee PTDs that include all the following information:
(1) An accurate and clear statement of the applicable designation of
the biogas.
(2) If the biogas is designated as a biointermediate, any applicable
requirement specified in Sec. 80.1453(f).
(3) One of the following statements, as applicable:
(i) For biogas designated for use to produce renewable CNG/LNG,
``This volume of biogas is designated and intended for use to produce
renewable CNG/LNG.''
(ii) For biogas designated for use to produce RNG, ``This volume of
biogas is designated and intended for use to produce renewable natural
gas.''
(iii) For biogas designated for use as a biointermediate, the
language found at Sec. 80.1453(f)(1)(vi).
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(iv) For biogas designated for use as process heat or energy under
Sec. 80.1426(f)(12) or (13), ``This volume of biogas is designated and
intended for use as process heat or energy.''
(c) PTD requirements for custodial transfers of RNG. On each
occasion when custody of RNG is transferred prior to injection into a
pipeline interconnect (e.g., via truck), the transferor must provide the
transferee PTDs that include all the following information:
(1) The applicable information listed in paragraph (a) of this
section.
(2) The following statement, ``This volume of RNG is designated and
intended for transportation use and may not be used for any other
purpose.''
(d) PTD requirements for imported RIN-less RNG. On each occasion
when title of RIN-less RNG is transferred and ultimately imported into
the covered location, the transferor must provide the transferee PTDs
that include all the following information:
(1) The applicable information listed in paragraph (a) of this
section.
(2) The following statement, ``This volume of RNG is designated and
intended for transportation use in the contiguous United States and may
not be used for any other purpose.''
(3) The name, EPA-issued company and facility IDs, and address of
the contracted RNG importer under Sec. 80.160(e).
(4) The name, EPA-issued company and facility IDs, and address of
the transferee.
Sec. 80.155 Sampling, testing, and measurement.
(a) Biogas and RNG continuous measurement. Any party required to
measure the volume of biogas, RNG, or renewable CNG/LNG under this
subpart must continuously measure using meters that comply with the
requirements in paragraphs (a)(1) and (2) of this section, or have an
accepted alternative measurement protocol as specified in paragraph
(a)(3) of this section:
(1) In-line GC meters compliant with ASTM D7164 (incorporated by
reference, see Sec. 80.12), including sections 9.2, 9.3, 9.4, 9.5, 9.7,
9.8, and 9.11 of ASTM D7164.
(2) Flow meters compliant with one of the following:
(i) API MPMS 14.3.1, API MPMS 14.3.2, API MPMS 14.3.3, and API MPMS
14.3.4 (incorporated by reference, see Sec. 80.12).
(ii) API MPMS 14.12 (incorporated by reference, see Sec. 80.12).
(iii) EN 17526 (incorporated by reference, see Sec. 80.12)
compatible with gas type H.
(3) EPA may accept an alternative measurement protocol if all the
following conditions are met:
(i) The party demonstrates that they are unable to continuously
measure using meters that comply with the requirements in paragraphs
(a)(1) and (2) of this section, as applicable.
(ii) The party demonstrates that the alternative measurement
protocol is at least as accurate and precise as the methods specified in
paragraphs (a)(1) and (2) of this section, as applicable.
(b) Biogas and RNG sampling and testing. Any party required to
sample and test biogas or RNG under this subpart must do so as follows:
(1) Collect representative samples of biogas or RNG using API MPMS
14.1 (incorporated by reference, see Sec. 80.12).
(2) Perform all the following measurements on each representative
sample:
(i) Methane, carbon dioxide, nitrogen, and oxygen using EPA Method
3C (see Appendix A-2 to 40 CFR part 60).
(ii) Hydrogen sulfide and total sulfur using ASTM D5504
(incorporated by reference, see Sec. 80.12).
(iii) Siloxanes using ASTM D8230 (incorporated by reference, see
Sec. 80.12).
(iv) Moisture using ASTM D4888 (incorporated by reference, see Sec.
80.12).
(v) Hydrocarbon analysis using EPA Method 18 (see Appendix A-6 to 40
CFR part 60).
(vi) Heating value and relative density using ASTM D3588
(incorporated by reference, see Sec. 80.12).
(vii) Additional components specified in the natural gas
specifications submitted under Sec. 80.135(d)(5) or specified by EPA as
a condition of registration under this part.
(viii) Carbon-14 analysis using ASTM D6866 (incorporated by
reference, see Sec. 80.12).
[[Page 140]]
(c) Digester feedstock. Any party required to test for total solids
and volatile solids of a digester feedstock under this subpart must do
so as follows:
(1) Samples must be tested in accordance with Part G of SM 2540
(incorporated by reference, see Sec. 80.12).
(2) Samples must be obtained, stored, and tested in accordance with
Part A of SM 2540, including Sections 2, 3, and 5 (Sources of Error and
Variability, Sample Handling and Preservation, and Quality Control).
(3) Parties must test each daily representative sample under
paragraphs (c)(1) and (2) of this section unless the party has a
composite sampling plan submitted to EPA under Sec.
80.135(c)(10)(vi)(D). Parties with a composite sampling plan must either
test each daily representative sample or test samples in accordance with
Part A of SM 2540 and as specified in the facility's composite sampling
plan.
(d) Digester operations. Any biogas producer required to measure or
calculate digester operating conditions under this subpart must
determine digester operating conditions for each mixed digester that
meet all the following requirements:
(1) Digester temperature readings must be recorded no less frequent
than every 30 minutes and represent the average temperature in the tank.
(2) Digester hydraulic and solids mean residence times must be
calculated no less frequent than once a day using measurements of
inflows, outflows, and tank levels, as applicable.
(3) Other parameters must be measured and calculated as specified in
the facility's registration under Sec. 80.135(c)(10)(vi)(A)(4).
(e) Third parties. Samples required to be obtained under this
subpart may be collected and analyzed by third parties.
(f) Unit conversions. A party converting between Btu HHV and Btu LHV
for biogas, treated biogas, natural gas, or CNG/LNG must use the ratio
of HHV and LHV of methane as specified in ASTM D3588 (incorporated by
reference, see Sec. 80.12).
(g) Liquid measurement and standardization. Any substance that is
liquid at STP must be measured in gallons and standardized according to
Sec. 80.1426(f)(8).
Sec. 80.160 RNG importers, foreign biogas producers, and foreign
RNG producers.
(a) Applicability. The provisions of this section apply to any RNG
importer or any foreign party subject to requirements of this subpart
outside the United States.
(b) General requirements. Any foreign party must meet all the
following requirements:
(1) Letter from RCO. The foreign party must provide a letter signed
by the RCO that commits the foreign party to the applicable provisions
specified in paragraphs (b)(4) and (c) of this section as part of their
registration under Sec. 80.135.
(2) Bond posting. A foreign party that generates RINs must meet the
bond requirements of Sec. 80.1466(h).
(3) Foreign RIN owners. A foreign party that owns RINs must meet the
requirements of Sec. 80.1467, including any foreign party that
separates or retires RINs under Sec. 80.125.
(4) Foreign party commitments. Any foreign party must commit to the
following provisions as a condition of being registered as a foreign
party under this subpart:
(i) Any EPA inspector or auditor must be given full, complete, and
immediate access to conduct inspections and audits of all facilities
subject to this subpart.
(A) Inspections and audits may be either announced in advance by
EPA, or unannounced.
(B) Access will be provided to any location where:
(1) Biogas, RNG, biointermediate, or biogas-derived renewable fuel
is produced.
(2) Documents related to the foreign party operations are kept.
(3) Any product subject to this subpart (e.g., biogas, RNG,
biointermediates, or biogas-derived renewable fuel) that is stored or
transported outside the United States between the foreign party's
facility and the point of importation into the United States, including
storage tanks, vessels, and pipelines.
(C) EPA inspectors and auditors may be EPA employees or contractors
to EPA.
[[Page 141]]
(D) Any documents requested that are related to matters covered by
inspections and audits must be provided to an EPA inspector or auditor
on request.
(E) Inspections and audits may include review and copying of any
documents related to the following:
(1) The volume or properties of any product subject to this subpart
produced or delivered to a renewable fuel production facility.
(2) Transfers of title or custody to the any product subject to this
subpart.
(3) Work performed and reports prepared by independent third parties
and by independent auditors under the requirements of this subpart,
including work papers.
(4) Records required under Sec. 80.145.
(5) Any records related to claims made during registration.
(F) Inspections and audits by EPA may include interviewing
employees.
(G) Any employee of the foreign party must be made available for
interview by the EPA inspector or auditor, on request, within a
reasonable time period.
(H) English language translations of any documents must be provided
to an EPA inspector or auditor, on request, within 10 business days.
(I) English language interpreters must be provided to accompany EPA
inspectors and auditors, on request.
(ii) An agent for service of process located in the District of
Columbia will be named, and service on this agent constitutes service on
the foreign party or any employee of the party for any action by EPA or
otherwise by the United States related to the requirements of this
subpart.
(iii) The forum for any civil or criminal enforcement action related
to the provisions of this subpart for violations of the Clean Air Act or
regulations promulgated thereunder are governed by the Clean Air Act,
including the EPA administrative forum where allowed under the Clean Air
Act.
(iv) United States substantive and procedural laws apply to any
civil or criminal enforcement action against the foreign party or any
employee of the foreign party related to the provisions of this subpart.
(v) Applying to be an approved foreign party under this subpart, or
producing or exporting any product subject to this subpart under such
approval, and all other actions to comply with the requirements of this
subpart relating to such approval constitute actions or activities
covered by and within the meaning of the provisions of 28 U.S.C.
1605(a)(2), but solely with respect to actions instituted against the
foreign party, its agents and employees in any court or other tribunal
in the United States for conduct that violates the requirements
applicable to the foreign party under this subpart, including conduct
that violates the False Statements Accountability Act of 1996 (18 U.S.C.
1001) and section 113(c)(2) of the Clean Air Act (42 U.S.C. 7413).
(vi) The foreign party, or its agents or employees, will not seek to
detain or to impose civil or criminal remedies against EPA inspectors or
auditors for actions performed within the scope of EPA employment or
contract related to the provisions of this subpart.
(vii) In any case where a product produced at a foreign facility is
stored or transported by another company between the foreign facility
and the point of importation to the United States, the foreign party
must obtain from each such other company a commitment that meets the
requirements specified in paragraphs (b)(4)(i) through (vi) of this
section before the product is transported to the United States, and
these commitments must be included in the foreign party's application to
be a registered foreign party under this subpart.
(c) Sovereign immunity. By submitting an application to be a
registered foreign party under this subpart, or by producing or
exporting any product subject to this subpart to the United States under
such registration, the foreign party, and its agents and employees,
without exception, become subject to the full operation of the
administrative and judicial enforcement powers and provisions of the
United States without limitation based on sovereign immunity, with
respect to actions instituted against the party, its agents and
employees in any court or other
[[Page 142]]
tribunal in the United States for conduct that violates the requirements
applicable to the foreign party under this subpart, including conduct
that violates the False Statements Accountability Act of 1996 (18 U.S.C.
1001) and section 113(c)(2) of the Clean Air Act (42 U.S.C. 7413).
(d) English language reports. Any document submitted to EPA by a
foreign party must be in English, or must include an English language
translation.
(e) Foreign RNG producer contractual relationship. A non-RIN
generating foreign RNG producer must establish a contractual
relationship with an RNG importer, prior to the sale of RIN-less RNG.
(f) Withdrawal or suspension of registration. EPA may withdraw or
suspend a foreign party's registration where any of the following occur:
(1) The foreign party fails to meet any requirement of this subpart.
(2) The foreign government fails to allow EPA inspections or audits
as provided in paragraph (b)(4)(i) of this section.
(3) The foreign party asserts a claim of, or a right to claim,
sovereign immunity in an action to enforce the requirements in this
subpart.
(4) The foreign party fails to pay a civil or criminal penalty that
is not satisfied using the bond required under paragraph (b)(2) of this
section.
(g) Additional requirements for applications, reports, and
certificates. Any application for registration as a foreign party, or
any report, certification, or other submission required under this
subpart by the foreign party, must be:
(1) Submitted using formats and procedures specified by EPA.
(2) Signed by the RCO of the foreign party's company.
(3) Contain the following declarations:
(i) Certification.
``I hereby certify:
That I have actual authority to sign on behalf of and to bind [NAME
OF FOREIGN PARTY] with regard to all statements contained herein.
That I am aware that the information contained herein is being
Certified, or submitted to the United States Environmental Protection
Agency, under the requirements of 40 CFR part 80, subparts E and M, and
that the information is material for determining compliance under these
regulations.
That I have read and understand the information being Certified or
submitted, and this information is true, complete, and correct to the
best of my knowledge and belief after I have taken reasonable and
appropriate steps to verify the accuracy thereof.''
(ii) Affirmation.
``I affirm that I have read and understand the provisions of 40 CFR
part 80, subparts E and M, including 40 CFR 80.160, 80.1466, and 80.1467
apply to [NAME OF FOREIGN PARTY]. Pursuant to Clean Air Act section
113(c) and 18 U.S.C. 1001, the penalty for furnishing false, incomplete,
or misleading information in this certification or submission is a fine
of up to $10,000 U.S., and/or imprisonment for up to five years.''
(h) Requirements for RNG importers. An RNG importer must meet all
the following requirements:
(1) For each imported batch of RNG, the RNG importer must have an
independent third party that meets the requirements of Sec.
80.1450(b)(2)(i) and (ii) do all the following:
(i) Determine the volume of RNG, in Btu LHV, injected into the
natural gas commercial pipeline system as specified in Sec. 80.155.
(ii) Determine the name and EPA-assigned company and facility
identification numbers of the foreign non-RIN generating RNG producer
that produced the RNG.
(2) The independent third party must submit reports to the foreign
non-RIN generating RNG producer and the RNG importer within 30 days
following the date the RNG was injected into a natural gas commercial
pipeline system for import into the United States containing all the
following:
(i) The statements specified in paragraph (g) of this section.
(ii) The name of the foreign non-RIN generating RNG producer,
containing the information specified in paragraph (g) of this section,
and including the identification of the natural gas commercial pipeline
system terminal at which the product was offloaded.
[[Page 143]]
(iii) PTDs showing the volume of RNG, in Btu LHV, transferred from
the foreign non-RIN generating RNG producer to the RNG importer.
(3) The RNG importer and the independent third party must keep
records of the audits and reports required under paragraphs (h)(1) and
(2) of this section for five years from the date of creation.
Sec. 80.165 Attest engagements.
(a) General provisions. (1) The following parties must arrange for
annual attestation engagement using agreed-upon procedures:
(i) Biogas producers.
(ii) RNG producers.
(iii) RNG importers.
(iv) Biogas closed distribution system RIN generators.
(v) RNG RIN separators.
(vi) Renewable fuel producers that use RNG as a feedstock.
(2) The auditor performing attestation engagements required under
this subpart must meet the requirements in 40 CFR 1090.1800(b).
(3) The auditor must perform attestation engagements separately for
each biogas production facility, RNG production facility, and renewable
fuel production facility, as applicable.
(4) Except as otherwise specified in this section, attest auditors
may use the representative sampling procedures specified in 40 CFR
1090.1805.
(5) Except as otherwise specified in this section, attest auditors
must prepare and submit the annual attestation engagement following the
procedures specified in 40 CFR 1090.1800(d).
(b) General procedures for biogas producers. An attest auditor must
conduct annual attestation audits for biogas producers using the
following procedures:
(1) Registration and EPA reports. The auditor must review
registration and EPA reports as follows:
(i) Obtain copies of all the following:
(A) The biogas producer's registration information submitted under
Sec. Sec. 80.135 and 80.1450.
(B) All reports submitted under Sec. Sec. 80.140 and 80.1451.
(ii) For each biogas production facility, confirm that the
facility's registration is accurate based on the activities reported
during the compliance period and confirm any related updates were
completed prior to conducting regulated activities at the facility and
report as a finding any exceptions.
(iii)(A) Report the date of the last engineering review conducted
under Sec. Sec. 80.135(b)(3) and 80.1450(b), as applicable.
(B) Report as a finding if the last engineering review is outside of
the schedule specified in Sec. 80.1450(d)(3)(ii).
(iv) Confirm that the biogas producer submitted all reports required
under Sec. Sec. 80.140 and 80.1451 for activities performed during the
compliance period and report as a finding any exceptions.
(2) Measurement method review. The auditor must review measurement
methods for each meter as follows:
(i) Obtain records related to measurement under Sec.
80.145(a)(1)(vi).
(ii)(A) Identify and report the name of the method(s) used for
measuring the volume of biogas, in Btu HHV and scf.
(B) Report as a finding any method that is not specified in Sec.
80.155 or the biogas producer's registration.
(iii)(A) Identify whether maintenance and calibration records were
kept for each meter and report the last date of calibration.
(B) Report as a finding if no records were obtained.
(3) Listing of batches. The auditor must review listings of batches
as follows:
(i) Obtain the batch reports submitted under Sec. 80.140.
(ii) Compare the reported volume for each batch to the measured
volume and report as a finding any exceptions.
(4) Testing of biogas transfers. The auditor must review biogas
transfers as follows:
(i) Obtain the associated PTD for each batch of biogas produced
during the compliance period.
(ii) Using the batch number, confirm that the correct PTD is
obtained for each batch and compare the volume, in Btu HHV and scf, on
each batch report to the associated PTD and report as a finding any
exceptions.
(iii) Confirm that the PTD associated with each batch contains all
applicable language requirements under Sec. 80.150 and report as a
finding any exceptions.
[[Page 144]]
(c) General procedures for RNG producers and importers. An attest
auditor must conduct annual attestation audits for RNG producers and
importers using the following procedures, as applicable:
(1) Registration and EPA reports. The auditor must review
registration and EPA reports as follows:
(i) Obtain copies of all the following:
(A) The RNG producer or importer's registration information
submitted under Sec. Sec. 80.135 and 80.1450.
(B) All reports submitted under Sec. Sec. 80.140 and 80.1451.
(ii) For each RNG production facility, confirm that the facility's
registration is accurate based on the activities reported during the
compliance period and confirm any related updates were completed prior
to conducting regulated activities at the facility and report as a
finding any exceptions.
(iii)(A) Report the date of the last engineering review conducted
under Sec. Sec. 80.135(b)(3) and 80.1450(b), as applicable.
(B) Report as a finding if the last engineering review is outside of
the schedule specified in Sec. 80.1450(d)(3)(ii).
(iv) Confirm that the RNG producer or importer submitted all reports
required under Sec. Sec. 80.140 and 80.1451 for activities performed
during the compliance period and report as a finding any exceptions.
(2) Feedstock received. The auditor must perform an inventory of
biogas received as follows:
(i) Obtain copies of all the following:
(A) Records documenting the source and volume of biogas, in Btu and
scf, received by the RNG producer.
(B) Records showing the volume of biogas used to produce RNG, in Btu
HHV and scf, and the volume of RNG produced, in Btu HHV and scf.
(C) Records showing whether non-renewable components were blended
into RNG.
(ii) Report the number of parties the RNG producer received biogas
from and the total volume received separately from each party.
(iii)(A) Report the total volume of biogas used to produce RNG, in
Btu HHV and scf, and the total volume of RNG produced, in Btu HHV and
scf.
(B) Report as a finding if the volume of RNG produced is greater
than the volume of biogas used to produce RNG, in Btu HHV.
(iv) Report as a finding if any RINs were generated for the non-
renewable components of the blended batch.
(3) Measurement method review. The auditor must review measurement
methods for each meter as follows:
(i) Obtain records related to measurement under Sec.
80.145(a)(1)(vi).
(ii)(A) Identify and report the name of the method(s) used for
measuring the volume of RNG, in Btu and in scf.
(B) Report as a finding any method that is not specified in Sec.
80.155 or the RNG producer's registration.
(iii) Identify whether maintenance and calibration records were kept
and report as a finding if no records were obtained.
(4) Listing of batches. The auditor must review listings of batches
as follows:
(i) Obtain the batch reports submitted under Sec. 80.140.
(ii) Compare the reported volume for each batch to the measured
volume and report as a finding any exceptions.
(iii) Report as a finding any batches with reported values that did
not meet the natural gas specifications submitted under Sec.
80.135(d)(5).
(5) Testing of RNG transfers. The auditor must review RNG transfers
as follows:
(i) Obtain the associated PTD for each batch of RNG produced or
imported during the compliance period.
(ii) Using the batch number, confirm that the correct PTD is
obtained for each batch and compare the volume, in Btu and scf, on each
batch report to the associated PTD and report as a finding any
exceptions.
(iii) Confirm that the PTD associated with each batch contains all
applicable language requirements under Sec. 80.150 and report as a
finding any exceptions.
(6) RNG RIN generation. The auditor must perform the following
procedures for monthly RIN generation:
(i) Obtain the RIN generation reports submitted under Sec. 80.1451.
(ii) Compare the number of RINs generated for each batch to the
batch report and report as a finding any exceptions.
[[Page 145]]
(iii)(A) Compare the number of RINs generated multiplied by 77,000
Btu to the amount of RNG injected into the natural gas commercial
pipeline system.
(B) Report as a finding if the volume of RNG injected is less than
the number of RINs generated multiplied by 77,000 Btu.
(d) General procedures for biogas closed distribution system RIN
generators. An attest auditor must conduct annual attestation audits for
biogas closed distribution system RIN generators using the following
procedures:
(1) Registration and EPA reports. The auditor must review
registration and EPA reports as follows:
(i) Obtain copies of all the following:
(A) The biogas closed distribution system RIN generator's
registration information submitted under Sec. 80.135.
(B) All reports submitted under Sec. 80.140.
(ii) Confirm that the biogas closed distribution system RIN
generator's registration is accurate based on the activities reported
during the compliance period and that any required updates were
completed prior to conducting regulated activities and report as a
finding any exceptions.
(iii) Confirm that the biogas closed distribution system RIN
generator submitted all reports required under Sec. Sec. 80.140 and
80.1451 for activities performed during the compliance period and report
as a finding any exceptions.
(2) RIN generation. The auditor must complete all applicable
requirements specified in Sec. 80.1464.
(e) General procedures for RNG RIN separators. An attest auditor
must conduct annual attestation audits for RNG RIN separators using the
following procedures:
(1) Registration and EPA reports. The auditor must review
registration and EPA reports as follows:
(i) Obtain copies of all the following:
(A) The RNG RIN separator's registration information submitted under
Sec. Sec. 80.135 and 80.1450.
(B) All reports submitted under Sec. Sec. 80.140 and 80.1451.
(ii) Confirm that the RNG RIN separator's registration is accurate
based on the activities reported during the compliance period and that
any required updates were completed prior to conducting regulated
activities and report as a finding any exceptions.
(iii) Confirm that the RNG RIN separator submitted all reports
required under Sec. Sec. 80.140 and 80.1451 for activities performed
during the compliance period and report as a finding any exceptions.
(2) RIN separation events. The auditor must review records
supporting RIN separation events as follows:
(i) Obtain copies of all the following:
(A) RIN separation reports submitted under Sec. Sec. 80.140(e) and
80.1452.
(B) RNG withdrawal records required under Sec. 80.145(e).
(ii)(A) Compare the volume of RNG, in Btu LHV, withdrawn from the
natural gas commercial pipeline system to the reported number of
separated RINs multiplied by 77,000 Btu used to produce the renewable
CNG/LNG.
(B) Report as a finding if the volume of RNG, in Btu LHV, is less
than the number of separated RINs multiplied by 77,000 Btu.
(iii)(A) Compare the volume of renewable CNG/LNG, in Btu LHV, to the
reported number of separated RINs multiplied by 77,000 Btu.
(B) Report as a finding if the volume of renewable CNG/LNG, in Btu
LHV, is less than the number of separated RINs multiplied by 77,000 Btu.
(3) RIN owner. The auditor must complete all the requirements
specified in Sec. 80.1464(c).
(f) General procedures for renewable fuel producers that use RNG as
a feedstock. An attest auditor must conduct annual attestation audits
for renewable fuel producers that use RNG as a feedstock using the
following procedures:
(1) Registration and EPA reports. The auditor must review
registration and EPA reports as follows:
(i) Obtain copies of all the following:
(A) The renewable fuel producer's registration information submitted
under Sec. 80.135.
(B) All reports submitted under Sec. 80.140.
(ii) Confirm that the renewable fuel producer's registration is
accurate based on the activities reported during the compliance period
and that any required updates were completed prior to
[[Page 146]]
conducting regulated activities and report as a finding any exceptions.
(iii) Confirm that the renewable fuel producers submitted all
reports required under Sec. Sec. 80.140 and 80.1451 for activities
performed during the compliance period and report as a finding any
exceptions.
(2) RIN retirements. The attest auditor must review RIN retirements
as follows:
(i) Obtain copies of all the following:
(A) RIN retirement reports submitted under Sec. Sec. 80.140(f) and
80.1452.
(B) Records related to measurement under Sec. 80.145(a)(1)(vi).
(ii) Compare the measured volume of RNG used as a feedstock to the
reported number of RINs retired for RNG.
(iii) Report as a finding if the measured volume of RNG used as a
feedstock does not match the number of RINs retired for RNG.
Sec. 80.170 Quality assurance plan.
(a) General requirements. This section specifies the requirements
for QAPs related to the verification of RINs generated for RNG and
biogas-derived renewable fuel.
(1) For the generation of Q-RINs for RNG or biogas-derived renewable
fuel, the same independent third-party auditor must verify each party as
follows:
(i) For RNG, all the RNG production facilities that inject into the
same pipeline interconnect and all the biogas production facilities that
provide feedstock to those RNG production facilities.
(ii) For renewable CNG/LNG produced from RNG, the biogas producer
and the RNG producer.
(iii) For renewable CNG/LNG produced from biogas in a biogas closed
distribution system, the biogas producer, the biogas closed distribution
system RIN generator, and any party deemed necessary by EPA to ensure
that the renewable CNG/LNG was used as transportation fuel.
(iv) For biogas-derived renewable fuel produced from biogas used as
a biointermediate, the biogas producer, the producer of the biogas-
derived renewable fuel, and any other party deemed necessary by EPA to
ensure that the biogas-derived renewable fuel was produced under an
approved pathway and used as transportation fuel.
(v) For biogas-derived renewable fuel produced from RNG used as a
feedstock, the producer of the biogas-derived renewable fuel and any
other party deemed necessary by EPA to ensure that the biogas-derived
renewable fuel was produced under an approved pathway and used as
transportation fuel.
(2) Independent third-party auditors that verify RINs generated
under this subpart must meet the requirements in Sec. 80.1471(a)
through (c), (g), and (h).
(3)(i) QAPs approved by EPA to verify RINs generated under this
subpart must meet the applicable requirements in Sec. 80.1469.
(ii) EPA may revoke or void a QAP as specified in Sec.
80.1469(e)(4) or (5).
(4) Independent third-party auditors must conduct quality assurance
audits at biogas production facilities, RNG production facilities,
renewable fuel production facilities, and any facility or location
deemed necessary by EPA to ensure that the biogas-derived renewable fuel
was produced under an approved pathway and used as transportation fuel,
heating oil, or jet fuel as specified in Sec. 80.1472.
(5) Independent third-party auditors must ensure that mass and
energy balances performed under Sec. 80.1469(c)(2) are consistent
between facilities that are audited as part of the same chain.
(b) Requirements for biogas production facilities. In addition to
the applicable elements verified under Sec. 80.1469, the independent
third-party auditor must do all the following for each biogas production
facility:
(1) Verify that the biogas was measured as required under Sec.
80.155.
(2) Verify that the PTDs for biogas transfers meet the applicable
PTD requirements in Sec. Sec. 80.150 and 80.1453.
(c) Requirements for RNG production facilities. In addition to the
applicable elements verified under Sec. 80.1469, the independent third-
party auditor must do all the following for each RNG production
facility:
(1) Verify that the RNG was sampled, tested, and measured as
required under Sec. 80.155.
(2) Verify that RINs were assigned, separated, and retired as
required
[[Page 147]]
under Sec. 80.125(c), (d), and (e), respectively.
(3) Verify that the RNG was injected into a natural gas commercial
pipeline system.
(4) Verify that RINs were not generated on non-renewable components
added to RNG prior to injection into a natural gas commercial pipeline
system.
(d) Requirements for renewable fuel production facilities using
biogas as a biointermediate. The independent third-party auditor must
meet all the requirements specified in paragraph (b) of this section and
Sec. 80.1477 for each renewable fuel production facility using biogas
as a biointermediate.
(e) Responsibility for replacement of invalid verified RINs. The
generator of RINs for RNG or a biogas-derived renewable fuel, and the
obligated party that owns the Q-RINs, are required to replace invalidly
generated Q-RINs with valid RINs as specified in Sec. 80.1431(b).
Sec. 80.175 Prohibited acts and liability provisions.
(a) Prohibited acts. (1) It is a prohibited act for any person to
act in violation of this subpart or fail to meet a requirement that
applies to that person under this subpart.
(2) No person may cause another person to commit an act in violation
of this subpart.
(b) Liability provisions--(1) General. (i) Any person who commits
any prohibited act or requirement in this subpart is liable for the
violation.
(ii) Any person who causes another person to commit a prohibited act
under this subpart is liable for that violation.
(iii) Any parent corporation is liable for any violation committed
by any of its wholly-owned subsidiaries.
(iv) Each partner to a joint venture, or each owner of a facility
owned by two or more owners, is jointly and severally liable for any
violation of this subpart that occurs at the joint venture facility or
facility owned by the joint owners, or any violation of this subpart
that is committed by the joint venture operation or any of the joint
owners of the facility.
(v) Any person listed in paragraphs (b)(2) through (4) of this
section is liable for any violation of a prohibition specified in
paragraph (a) of this section or failure to meet a requirement of any
provision of this subpart regardless of whether the person violated or
caused the violation unless the person establishes an affirmative
defense under Sec. 80.180.
(vi) The liability provisions of Sec. 80.1461 also apply to any
person subject to the provisions of this subpart.
(2) Biogas liability. When biogas is found in violation of a
prohibition specified in paragraph (a) of this section or Sec. 80.1460,
the following persons are deemed in violation:
(i) The biogas producer that produced the biogas.
(ii) Any RNG producer that used the biogas to produce RNG.
(iii) Any biointermediate producer that used the biogas to produce a
biointermediate.
(iv) Any person that used the biogas, RNG produced from the biogas,
or biointermediate produced from the biogas to produce a biogas-derived
renewable fuel.
(v) Any person that generated a RIN from a biogas-derived renewable
fuel produced from the biogas, RNG produced from the biogas, or
biointermediate produced from the biogas.
(vi) Any person that used the biogas or RNG produced from the biogas
as process heat or energy under Sec. 80.1426(f)(12) or (13).
(3) RNG liability. When RNG is found in violation of a prohibition
specified in paragraph (a) of this section or Sec. 80.1460, the
following persons are deemed in violation:
(i) The biogas producer that produced the biogas used to produce the
RNG.
(ii) The RNG producer that produced the RNG.
(iii) Any person that used the RNG as a feedstock.
(iv) Any person that used the RNG as process heat or energy under
Sec. 80.1426(f)(12) or (13).
(v) Any person that generated a RIN from a biogas-derived renewable
fuel produced from the RNG or biointermediate produced from the RNG.
[[Page 148]]
(4) Third-party liability. Any party allowed under this subpart to
act on behalf of a regulated party and does so to demonstrate compliance
with the requirements of this subpart must meet those requirements in
the same way that the regulated party must meet those requirements. The
regulated party and the third party are both liable for any violations
arising from the third party's failure to meet the requirements of this
subpart.
Sec. 80.180 Affirmative defense provisions.
(a) Applicability. A person may establish an affirmative defense to
a violation that person is liable for under Sec. 80.175(b) if that
person satisfies all applicable elements of an affirmative defense in
this section.
(1) No person that generates a RIN for biogas-derived renewable fuel
may establish an affirmative defense under this section.
(2) A person that is a biogas producer may not establish an
affirmative defense under this section for a violation that the biogas
producer is liable for under Sec. 80.175(b)(1) and (2).
(3) A person that is an RNG producer may not establish an
affirmative defense under this section for a violation that the RNG
producer is liable for under Sec. 80.175(b)(1) and (3).
(b) General elements. A person may only establish an affirmative
defense under this section if the person meets all the following
requirements:
(1) The person, or any of the person's employees or agents, did not
cause the violation.
(2) The person did not know or have reason to know that the biogas,
treated biogas, RNG, biogas-derived renewable fuel, or RIN was in
violation of a prohibition or requirement under this subpart.
(3) The person must have had no financial interest in the company
that caused the violation.
(4) If the person self-identified the violation, the person notified
EPA within five business days of discovering the violation.
(5) The person must submit a written report to the EPA including all
pertinent supporting documentation, demonstrating that the applicable
elements of this section were met within 30 days of the person
discovering the invalidity.
(c) Biogas producer elements. In addition to the elements specified
in paragraph (b) of this section, a biogas producer must also meet all
the following requirements to establish an affirmative defense:
(1) The biogas producer conducted or arranged to be conducted a
quality assurance program that includes, at a minimum, a periodic
sampling, testing, and measurement program adequately designed to ensure
their biogas meets the applicable requirements to produce biogas under
this part.
(2) The biogas producer had all affected biogas verified by a third-
party auditor under an approved QAP under Sec. Sec. 80.170 and 80.1469.
(3) The PTDs for the biogas indicate that the biogas was in
compliance with the applicable requirements while in the biogas
producer's control.
(d) RNG producer elements. In addition to the elements specified in
paragraph (b) of this section, an RNG producer must also meet all the
following requirements to establish an affirmative defense:
(1) The RNG producer conducted or arranged to be conducted a quality
assurance program that includes, at a minimum, a periodic sampling,
testing, and measurement program adequately designed to ensure that the
biogas used to produce their RNG meets the applicable requirements to
produce biogas under this part and that their RNG meets the applicable
requirements to produce RNG under this part.
(2) The RNG producer had all affected biogas and RNG verified by a
third-party auditor under an approved QAP under Sec. Sec. 80.170 and
80.1469.
(3) The PTDs for the biogas used to produce their RNG and for their
RNG indicate that the biogas and RNG were in compliance with the
applicable requirements while in the RNG producer's control.
Sec. 80.185 Potentially invalid RINs.
(a) Identification and treatment of potentially invalid RINs (PIRs).
(1) Any RIN can be identified as a PIR by the biogas producer, the RIN
generator,
[[Page 149]]
the independent third-party auditor that verified the RIN, or EPA.
(2) Any party listed in paragraph (a)(1) of this section must use
the procedures specified in Sec. 80.1474(b) for identification and
treatment of PIRs and retire any PIRs under Sec. 80.1434(a).
(b) Potentially inaccurate or non-qualifying volumes of biogas-
derived renewable fuel. (1) Any party that becomes aware of a volume of
biogas-derived renewable fuel that does not meet the applicable
requirements for such fuel under this part must notify the next party in
the production chain within 5 business days.
(i) Biointermediate producers must notify the renewable fuel
producer receiving the biointermediate within 5 business days.
(ii) If the volume of biogas-derived renewable fuel was audited
under Sec. 80.170, the party must notify the independent third-party
auditor within 5 business days.
(iii) Non-RIN generating foreign RNG producers must comply with the
requirements of this section and notify the importer generating RINs and
other parties in the production chain, as applicable.
(iv) Each notified party must notify EPA within 5 business days.
(2) Any party that is notified of a volume of biogas-derived
renewable fuel that does not meet the applicable requirements for such
fuel under this part must correct affected volumes of biogas-derived
renewable fuel under paragraph (a)(2) of this section, as applicable.
(c) Potential double counting. (1)(i) When any party becomes aware
of any of the following, they must notify EPA and the RIN generator, if
known, within 5 business days of initial discovery:
(A) More than one RIN being generated for renewable fuel produced
from the same volume of biogas, treated biogas, or RNG.
(B) More than one RIN being generated for the same volume of biogas-
derived renewable fuel or RNG.
(C) A party taking credit for biogas, treated biogas, or RNG under a
non-transportation program (e.g., a stationary-source renewable
electricity program) and also generating RINs for renewable fuel
produced from that same volume of biogas, treated biogas, or RNG.
(D) A party taking credit for biogas-derived renewable fuel or RNG
under a non-transportation program (e.g., a stationary-source renewable
electricity program) and also generating RINs for that same volume of
biogas-derived renewable fuel or RNG.
(E) A party taking credit for biogas, treated biogas, or RNG used
outside the covered location and also generating RINs for renewable fuel
produced from that same volume of biogas, treated biogas, or RNG.
(F) A party taking credit for biogas-derived renewable fuel or RNG
used outside the covered location and also generating RINs for that same
volume of biogas-derived renewable fuel or RNG.
(ii) When any party becomes aware of another party separating or
retiring a RIN from the same volume of RNG, they must notify EPA and the
RIN generator, if known, within 5 business days of initial discovery.
(2) EPA will notify the RIN generator of the potential double
counting if the party that identified the potential double counting does
not know the party that generated the potentially affected RINs.
(3) Upon notification, the RIN generator must then calculate any
impacts to the number of RINs generated for the volume of impacted RNG
or renewable fuel. The RIN generator must then notify EPA and the
independent third-party auditor, if any, of the impacted RINs within 5
business days of initial notification.
(4) For any number of RINs over-generated due to the double counting
of volumes of biogas or RNG, the RIN generator must follow the
applicable procedures for invalid RINs specified in Sec. 80.1431.
(d) Failure to take corrective action. Any person who fails to meet
a requirement under paragraph (b) or (c) of this section is liable for
full performance of such requirement, and each day of non-compliance is
deemed a separate violation pursuant to Sec. 80.1460(f). The
administrative process for replacement of invalid RINs does not, in any
way, limit the ability of the United States to exercise any other
authority to bring an
[[Page 150]]
enforcement action under section 211 of the Clean Air Act, the fuels
regulations under this part, 40 CFR part 1090, or any other applicable
law.
(e) Replacing PIRs or invalid RINs. The following specifications
apply when retiring valid RINs to replace PIRs or invalid RINs:
(1) When a RIN is retired to replace a PIR or invalid RIN, the D
code of the retired RIN must be eligible to be used towards meeting all
the renewable volume obligations as the PIR or invalid RIN it is
replacing, as specified in Sec. 80.1427(a)(2).
(2) The number of RINs retired must be equal to the number of PIRs
or invalid RINs being replaced.
(f) Forms and procedures. (1) All parties that retire RINs under
this section must use forms and procedures specified by EPA.
(2) All parties that must notify EPA under this section must submit
those notifications to EPA as specified in 40 CFR 1090.10.
Subparts F-L [Reserved]
Subpart M_Renewable Fuel Standard
Source: 75 FR 14863, Mar. 26, 2010, unless otherwise noted.
Sec. 80.1400 Applicability.
The provisions of this Subpart M shall apply for all renewable fuel
produced on or after July 1, 2010, for all RINs generated on or after
July 1, 2010, and for all renewable volume obligations and compliance
periods starting with January 1, 2010.
[75 FR 14863, Mar. 26, 2010, as amended at 85 FR 78467, Dec. 4, 2020]
Sec. 80.1401 Definitions.
The definitions of Sec. 80.2 apply for the purposes of this subpart
M.
[88 FR 44580, July 12, 2023]
Sec. 80.1402 Availability of information; confidentiality of information.
(a) Beginning January 1, 2020, no claim of business confidentiality
may be asserted by any person with respect to information submitted to
EPA under Sec. 80.1451(c)(2)(ii)(E), whether submitted electronically
or in paper format.
(b) The following information contained in EPA determinations that
RINs are invalid under Sec. 80.1474(b)(4)(i)(C)(2) and
(b)(4)(ii)(C)(2), notices of violation, settlement agreements,
administrative complaints, civil complaints, criminal information, and
criminal indictments arising under this subpart is not entitled to
confidential treatment and the provisions of 40 CFR 2.201 through 2.215
and 2.301 do not apply:
(1) The company name.
(2) The name and location of the facility at which the fuel
associated with the RINs in question was allegedly produced or imported.
(3) The EPA-issued company or facility identification number of the
party that produced the fuel or generated the RINs in question.
(4) The total quantity of fuel and RINs in question.
(5) The time period when the fuel was allegedly produced.
(6) The time period when the RINs in question were generated.
(7) The batch number(s) and the D code(s) of the RINs in question.
(8) Information relating to the generation, transfer, or use of
RINs.
(9) The shortfall in RINs related to an obligated party's failure to
meet its renewable volume obligation.
(10) Any other information relevant to describing the violation.
(c) The following information contained in submissions under this
subpart is not entitled to confidential treatment and the provisions of
40 CFR 2.201 through 2.215 and 2.301 do not apply:
(1) Submitter's name.
(2) The name and location of the facility, if applicable.
(3) The date the submission was transmitted to EPA.
(4) Any EPA-issued company or facility identification numbers
associated with the submission.
(5) The purpose of the submission.
(6) The relevant time period for the submission, if applicable.
(d) The following information incorporated into EPA determinations
on submissions under this subpart is not entitled to confidential
treatment and
[[Page 151]]
the provisions of 40 CFR 2.201 through 2.215 and 2.301 do not apply:
(1) Submitter's name.
(2) The name and location of the facility, if applicable.
(3) The date the submission was transmitted to EPA.
(4) Any EPA-issued company or facility identification numbers
associated with the submission.
(5) The purpose of the submission.
(6) The relevant time period of the submission, if applicable.
(7) The extent to which EPA granted or denied the request and any
relevant terms and conditions.
(e) Except as otherwise specified in this section, any information
submitted under this part claimed as confidential remains subject to
evaluation by EPA under 40 CFR part 2, subpart B.
(f) EPA may disclose the information specified in paragraphs (a)
through (d) of this section on its website, or otherwise make it
available to interested parties, without additional notice or process,
regardless of any claims that the information is entitled to
confidential treatment under 40 CFR part 2, subpart B.
[87 FR 39661, July 1, 2022, as amended at 88 FR 44580, July 12, 2023]
Sec. 80.1403 Which fuels are not subject to the 20% GHG thresholds?
(a) For purposes of this section, the following definitions apply:
(1) Commence construction, as applied to facilities that produce
renewable fuel, means that:
(i) The owner or operator has all necessary preconstruction
approvals or permits (as defined at 40 CFR 52.21(b)(10)), and has
satisfied either of the following:
(A) Begun, or caused to begin, a continuous program of actual
construction on-site (as defined in 40 CFR 52.21(b)(11)).
(B) Entered into binding agreements or contractual obligations,
which cannot be cancelled or modified without substantial loss to the
owner or operator, to undertake a program of actual construction of the
facility.
(ii) For multi-phased projects, the commencement of construction of
one phase does not constitute commencement of construction of any later
phase, unless each phase is mutually dependent for physical and chemical
reasons only.
(2) [Reserved]
(b) The lifecycle greenhouse gas emissions from renewable fuels must
be at least 20 percent less than baseline lifecycle greenhouse gas
emissions, with the exception of the baseline volumes of renewable fuel
produced from facilities described in paragraphs (c) and (d) of this
section.
(c) The baseline volume of renewable fuel that is produced from
facilities and any expansions, all of which commenced construction on or
before December 19, 2007, shall not be subject to the requirement that
lifecycle greenhouse gas emissions be at least 20 percent less than
baseline lifecycle greenhouse gas emissions if the owner or operator:
(1) Did not discontinue construction for a period of 18 months after
commencement of construction; and
(2) Completed construction by December 19, 2010.
(d) The baseline volume of ethanol that is produced from facilities
and any expansions all of which commenced construction after December
19, 2007 and on or before December 31, 2009, shall not be subject to the
requirement that lifecycle greenhouse gas emissions be at least 20
percent less than baseline lifecycle greenhouse gas emissions if such
facilities are fired with natural gas, biomass, or a combination thereof
at all times the facility operated between December 19, 2007 and
December 31, 2009 and if:
(1) The owner or operator did not discontinue construction for a
period of 18 months after commencement of construction;
(2) The owner or operator completed construction within 36 months of
commencement of construction; and
(3) The baseline volume continues to be produced through processes
fired with natural gas, biomass, or any combination thereof.
(e) The annual volume of renewable fuel during a calendar year from
facilities described in paragraphs (c) and (d) of this section that
exceeds the baseline volume shall be subject to the requirement that
lifecycle greenhouse gas emissions be at least 20 percent less
[[Page 152]]
than baseline lifecycle greenhouse gas emissions.
(f) If there are any changes in the mix of renewable fuels produced
by those facilities described in paragraph (d) of this section, only the
ethanol volume (to the extent it is less than or equal to baseline
volume) will not be subject to the requirement that lifecycle greenhouse
gas emissions be at least 20 percent less than baseline lifecycle
greenhouse gas emissions. Any party that changes the fuel mix must
update their registration as specified in Sec. 80.1450(d).
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26036, May 10, 2010; 75
FR 37733, June 30, 2010; 75 FR 79976, Dec. 21, 2010]
Sec. 80.1404 [Reserved]
Sec. 80.1405 What are the Renewable Fuel Standards?
(a) The values of the renewable fuel standards are as follows:
Table 1 to Paragraph (a)--Annual Renewable Fuel Standards
----------------------------------------------------------------------------------------------------------------
Supplemental
Cellulosic Biomass-based Advanced Renewable fuel total
Year biofuel diesel biofuel standard (%) renewable fuel
standard (%) standard (%) standard (%) standard (%)
----------------------------------------------------------------------------------------------------------------
2010............................ 0.004 1.10 0.61 8.25 n/a
2011............................ n/a 0.69 0.78 8.01 n/a
2012............................ n/a 0.91 1.21 9.23 n/a
2013............................ 0.0005 1.13 1.62 9.74 n/a
2014............................ 0.019 1.41 1.51 9.19 n/a
2015............................ 0.069 1.49 1.62 9.52 n/a
2016............................ 0.128 1.59 2.01 10.10 n/a
2017............................ 0.173 1.67 2.38 10.70 n/a
2018............................ 0.159 1.74 2.37 10.67 n/a
2019............................ 0.230 1.73 2.71 10.97 n/a
2020............................ 0.32 2.30 2.93 10.82 n/a
2021............................ 0.33 2.16 3.00 11.19 n/a
2022............................ 0.35 2.33 3.16 11.59 0.14
2023............................ 0.48 2.58 3.39 11.96 0.14
2024............................ 0.63 2.82 3.79 12.50 n/a
2025............................ 0.81 3.15 4.31 13.13 n/a
----------------------------------------------------------------------------------------------------------------
(b) EPA will calculate the value of the annual standards and publish
these values in the Federal Register by November 30 of the year
preceding the compliance period.
(c) EPA will calculate the annual renewable fuel percentage
standards using the following equations:
[GRAPHIC] [TIFF OMITTED] TR12JY23.008
[GRAPHIC] [TIFF OMITTED] TR12JY23.009
[GRAPHIC] [TIFF OMITTED] TR12JY23.010
[GRAPHIC] [TIFF OMITTED] TR12JY23.011
Where:
StdCB,i = The cellulosic biofuel standard for year i, in
percent.
StdBBD,i = The biomass-based diesel standard for year i, in
percent.
[[Page 153]]
StdAB,i = The advanced biofuel standard for year i, in
percent.
StdRF,i = The renewable fuel standard for year i, in percent.
RFVCB,i = Annual volume of cellulosic biofuel required by 42
U.S.C. 7545(o)(2)(B) for year i, or volume as adjusted
pursuant to 42 U.S.C. 7545(o)(7)(D), in gallons.
RFVBBD,i = Annual volume of biomass-based diesel required by
42 U.S.C. 7545 (o)(2)(B) for year i, in gallons.
RFVAB,i = Annual volume of advanced biofuel required by 42
U.S.C. 7545(o)(2)(B) for year i, in gallons.
RFVRF,i = Annual volume of renewable fuel required by 42
U.S.C. 7545(o)(2)(B) for year i, in gallons.
Gi = Amount of gasoline projected to be used in the covered
location, in year i, in gallons.
Di = Amount of diesel projected to be used in the covered
location, in year i, in gallons.
RGi = Amount of renewable fuel blended into gasoline that is
projected to be consumed in the covered location, in year i,
in gallons.
RDi = Amount of renewable fuel blended into diesel that is
projected to be consumed in the covered location, in year i,
in gallons.
GSi = Amount of gasoline projected to be used in Alaska or a
U.S. territory, in year i, if the state or territory has
opted-in or opts-in, in gallons.
RGSi = Amount of renewable fuel blended into gasoline that is
projected to be consumed in Alaska or a U.S. territory, in
year i, if the state or territory opts-in, in gallons.
DSi = Amount of diesel projected to be used in Alaska or a
U.S. territory, in year i, if the state or territory has
opted-in or opts-in, in gallons.
RDSi = Amount of renewable fuel blended into diesel that is
projected to be consumed in Alaska or a U.S. territory, in
year i, if the state or territory opts-in, in gallons.
GEi = The total amount of gasoline projected to be exempt in
year i, in gallons, per Sec. Sec. 80.1441 and 80.1442.
DEi = The total amount of diesel fuel projected to be exempt
in year i, in gallons, per Sec. Sec. 80.1441 and 80.1442.
(d) The price for cellulosic biofuel waiver credits will be
calculated in accordance with Sec. 80.1456(d) and published on EPA's
Web site.
[77 FR 1354, Jan. 9, 2012, as amended at 78 FR 49830, Aug. 15, 2013; 79
FR 25031, May 2, 2014; 80 FR 18140, Apr. 3, 2015; 80 FR 77517, Dec. 14,
2015; 81 FR 89804, Dec. 12, 2016; 82 FR 58527, Dec. 12, 2017; 83 FR
63744, Dec. 11, 2018; 85 FR 7074, Feb. 6, 2020; 87 FR 39661, July 1,
2022; 88 FR 44580, July 12, 2023]
Sec. 80.1406 Obligated party responsibilities.
(a) [Reserved]
(b) For each compliance period starting with 2010, an obligated
party is required to demonstrate, pursuant to Sec. 80.1427, that it has
satisfied the Renewable Volume Obligations for that compliance period,
as specified in Sec. 80.1407(a).
(c) Aggregation of facilities--(1) Except as provided in paragraphs
(c)(2), (d) and (e) of this section, an obligated party may comply with
the requirements of paragraph (b) of this section in the aggregate for
all of the refineries that it operates, or for each refinery
individually.
(2) An obligated party that carries a deficit into year i + 1 must
use the same approach to aggregation of facilities in year i + 1 as it
did in year i.
(d) An obligated party must comply with the requirements of
paragraph (b) of this section for all of its imported gasoline or diesel
fuel in the aggregate.
(e) An obligated party that is both a refiner and importer must
comply with the requirements of paragraph (b) of this section for its
imported gasoline or diesel fuel separately from gasoline or diesel fuel
produced by its domestic refinery or refineries.
(f) Where a refinery or import facility is jointly owned by two or
more parties, the requirements of paragraph (b) of this section may be
met by one of the joint owners for all of the gasoline or diesel fuel
produced/imported at the facility, or each party may meet the
requirements of paragraph (b) of this section for the portion of the
gasoline or diesel fuel that it produces or imports, as long as all of
the gasoline or diesel fuel produced/imported at the facility is
accounted for in determining the Renewable Volume Obligations under
Sec. 80.1407. In either case, all joint
[[Page 154]]
owners are subject to the liability provisions of Sec. 80.1461(d).
(g) The requirements in paragraph (b) of this section apply to the
following compliance periods: Beginning in 2010, and every year
thereafter, the compliance period is January 1 through December 31.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26037, May 10, 2010; 88
FR 44581, July 12, 2023]
Sec. 80.1407 How are the Renewable Volume Obligations calculated?
(a) The Renewable Volume Obligations for an obligated party are
determined according to the following formulas:
(1) Cellulosic biofuel.
RVOCB,i = (RFStdCB,i * (GVi +
DVi)) + DCB,i-1
Where:
RVOCB,i = The Renewable Volume Obligation for cellulosic
biofuel for an obligated party for calendar year i, in
gallons.
RFStdCB,i = The standard for cellulosic biofuel for calendar
year i, determined by EPA pursuant to Sec. 80.1405, in
percent.
GVi = The non-renewable gasoline volume, determined in
accordance with paragraphs (b), (c), and (f) of this section,
which is produced in or imported into the covered location by
an obligated party in calendar year i, in gallons.
DVi = The non-renewable diesel volume, determined in
accordance with paragraphs (d), (e), and (f) of this section,
produced in or imported into the covered location by an
obligated party in calendar year i, in gallons.
DCB,i-1 = Deficit carryover from the previous year for
cellulosic biofuel, in gallons.
(2) Biomass-based diesel.
RVOBBD,i = (RFStdBBD,i * (GVi +
DVi)) + DBBD,i-1
Where:
RVOBBD,i = The Renewable Volume Obligation for biomass-based
diesel for an obligated party for calendar year i, in gallons.
RFStdBBD,i = The standard for biomass-based diesel for
calendar year i, determined by EPA pursuant to Sec. 80.1405,
in percent.
GVi = The non-renewable gasoline volume, determined in
accordance with paragraphs (b), (c), and (f) of this section,
which is produced in or imported into the covered location by
an obligated party in calendar year i, in gallons.
DVi = The non-renewable diesel volume, determined in
accordance with paragraphs (d), (e), and (f) of this section,
produced in or imported into the covered location by an
obligated party in calendar year i, in gallons.
DBBD,i-1 = Deficit carryover from the previous year for
biomass-based diesel, in gallons.
(3) Advanced biofuel.
RVOAB,i = (RFStdAB,i * (GVi +
DVi)) + DAB,i-1
Where:
RVOAB,i = The Renewable Volume Obligation for advanced
biofuel for an obligated party for calendar year i, in
gallons.
RFStdAB,i = The standard for advanced biofuel for calendar
year i, determined by EPA pursuant to Sec. 80.1405, in
percent.
GVi = The non-renewable gasoline volume, determined in
accordance with paragraphs (b), (c), and (f) of this section,
which is produced in or imported into the covered location by
an obligated party in calendar year i, in gallons.
DVi = The non-renewable diesel volume, determined in
accordance with paragraphs (d), (e), and (f) of this section,
produced in or imported into the covered location by an
obligated party in calendar year i, in gallons.
DAB,i-1 = Deficit carryover from the previous year for
advanced biofuel, in gallons.
(4) Renewable fuel.
RVORF,i = (RFStdRF,i * (GVi +
DVi)) + DRF,i-1
Where:
RVORF,i = The Renewable Volume Obligation for renewable fuel
for an obligated party for calendar year i, in gallons.
RFStdRF,i = The standard for renewable fuel for calendar year
i, determined by EPA pursuant to Sec. 80.1405, in percent.
GVi = The non-renewable gasoline volume, determined in
accordance with paragraphs (b), (c), and (f) of this section,
which is produced in or imported into the covered location by
an obligated party in calendar year i, in gallons.
DVi = The non-renewable diesel volume, determined in
accordance with paragraphs (d), (e), and (f) of this section,
produced in or imported into the covered location by an
obligated party in calendar year i, in gallons.
DRF,i-1 = Deficit carryover from the previous year for
renewable fuel, in gallons.
(b) The non-renewable gasoline volume, GVi, for an
obligated party for a given year as specified in paragraph (a) of this
section is calculated as follows:
[[Page 155]]
[GRAPHIC] [TIFF OMITTED] TR26MR10.430
Where:
x = Individual batch of gasoline produced or imported in calendar year
i.
n = Total number of batches of gasoline produced or imported in calendar
year i.
GX = Volume of batch x of gasoline produced or imported, per
paragraph (c) of this section, in gallons.
y = Individual batch of renewable fuel blended into gasoline in calendar
year i.
m = Total number of batches of renewable fuel blended into gasoline in
calendar year i.
RBGy = Volume of batch y of renewable fuel blended into
gasoline, in gallons.
(c) Except as specified in paragraph (f) of this section, all of the
following products that are produced or imported during a compliance
period, collectively called ``gasoline'' for the purposes of this
section (unless otherwise specified), are to be included (but not
double-counted) in the volume used to calculate a party's Renewable
Volume Obligations under paragraph (a) of this section, except as
provided in paragraph (f) of this section:
(1) Reformulated gasoline, whether or not renewable fuel is later
added to it.
(2) Conventional gasoline, whether or not renewable fuel is later
added to it.
(3) Reformulated gasoline blendstock that becomes finished
reformulated gasoline upon the addition of oxygenate (RBOB).
(4) Conventional gasoline blendstock that becomes finished
conventional gasoline upon the addition of oxygenate (CBOB).
(5) Blendstock (including butane, pentane, and gasoline treated as
blendstock (GTAB)) that has been combined with other blendstock and/or
finished gasoline to produce gasoline.
(6) Any gasoline, or any unfinished gasoline that becomes finished
gasoline upon the addition of oxygenate, that is produced or imported to
comply with a state or local fuels program.
(d) The diesel non-renewable volume, DVi, for an
obligated party for a given year as specified in paragraph (a) of this
section is calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR26MR10.431
Where:
x = Individual batch of diesel produced or imported in calendar year i.
n = Total number of batches of diesel produced or imported in calendar
year i.
DX = Volume of batch x of diesel produced or imported, per
paragraph (e) of this section, in gallons.
y = Individual batch of renewable fuel blended into diesel in calendar
year i.
m = Total number of batches of renewable fuel blended into diesel in
calendar year i.
RBDy = Volume of batch y of renewable fuel blended into
diesel, in gallons.
(e) Except as specified in paragraph (f) of this section, all
products meeting the definition of MVNRLM diesel fuel that are produced
or imported during a compliance period, collectively called ``diesel
fuel'' for the purposes of this section (unless otherwise specified),
are to be included (but not double-counted) in the volume used to
calculate a party's Renewable Volume Obligations under paragraph (a) of
this section.
(f) The following products are not included in the volume of
gasoline or diesel fuel produced or imported used to calculate a party's
Renewable Volume Obligations according to paragraph (a) of this section:
(1) Any renewable fuel. Renewable fuel for which a RIN is invalidly
generated under Sec. 80.1431 may not be excluded from a party's
renewable volume obligations.
(2) Blendstock that has not been combined with other blendstock,
finished gasoline, or diesel to produce gasoline or diesel.
(3) Gasoline or diesel fuel produced or imported for use in Alaska,
the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American
Samoa, and the Commonwealth of the Northern Marianas, unless the area
has opted into the RFS program under Sec. 80.1443.
[[Page 156]]
(4) Gasoline or diesel fuel produced by a small refinery that has an
exemption under Sec. 80.1441 or an approved small refiner that has an
exemption under Sec. 80.1442.
(5) Gasoline or diesel fuel exported for use outside the covered
location, and gasoline or diesel fuel exported for use outside Alaska,
the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American
Samoa, and the Commonwealth of the Northern Marianas, if the area has
opted into the RFS program under Sec. 80.1443.
(6) For blenders, the volume of finished gasoline, finished diesel
fuel, RBOB, or CBOB to which a blender adds blendstocks.
(7) Transmix gasoline product (as defined in 40 CFR 1090.80) and
transmix distillate product (as defined in 40 CFR 1090.80) produced by a
transmix processor, and transmix blended into gasoline or diesel fuel by
a transmix blender under 40 CFR 1090.500.
(8) Any gasoline or diesel fuel that is not transportation fuel.
(9) Distillate fuel with a sulfur content greater than 15 ppm that
is clearly designated for a use other than transportation fuel, such as
heating oil or ECA marine fuel.
(10) Distillate fuel that meets a 15 ppm sulfur standard, is
designated for non-transportation use, and that remains completely
segregated from MVNRLM diesel fuel from the point of production through
to the point of use for a non-transportation purpose, such as heating
oil or ECA marine fuel.
(11) Certified NTDF, if the refiner or importer has a reasonable
expectation that the fuel will be used for non-transportation purposes.
To establish a reasonable expectation that the fuel will be used for
non-transportation purposes, a refiner or importer must, at a minimum,
be able to demonstrate that they supply areas that use heating oil, ECA
marine fuel, or 15 ppm distillate fuel for non-transportation purposes
in quantities that are consistent with past practices or changed
circumstances. EPA may consider any other relevant information,
including the price of the fuel, in assessing whether a refiner or
importer has a reasonable expectation that the fuel will be used for
non-transportation purposes.
[75 FR 14863, Mar. 26, 2010, as amended at 79 FR 23655, Apr. 28, 2014;
85 FR 7074, Feb. 6, 2020; 85 FR 78467, Dec. 4, 2020; 87 FR 39661, July
1, 2022; 88 FR 44581, July 12, 2023]
Sec. 80.1408 What are the requirements for parties that own and
redesignate certified NTDF as MVNRLM diesel fuel?
(a) Beginning January 1, 2021, a party that owns certified NTDF, and
only a party that owns certified NTDF, may redesignate NTDF as MVNRLM
diesel fuel if they meet all of the following requirements:
(1) Register as a refiner and register each facility where
redesignation occurs as a refinery under Sec. 80.76. NTDF may only be
redesignated as MVNRLM diesel fuel at a facility registered as a
refinery.
(2) At each facility, calculate a balance of MVNRLM diesel fuel
during each annual compliance period according to the following
equation:
MVNRLMBAL = MVNRLMO + MVNRLMINVCHG-
MVNRLMI
Where:
MVNRLMBAL = the balance for MVNRLM diesel fuel for the
compliance period.
MVNRLMI = the total volume of all batches of fuel designated
as MVNRLM diesel fuel owned when the fuel was received at the
facility and acquired at the facility during the compliance
period. Any MVNRLM diesel fuel produced (apart from
redesignation of NTDF to MVNRLM diesel fuel) or imported into
the facility must also be included in this volume.
MVNRLMO = the total volume of all batches of fuel designated
as MVNRLM diesel fuel owned and sold or transferred to other
parties at the facility during the compliance period.
MVNRLMINVCHG = the volume of MVNRLM diesel fuel owned at the
end of the compliance period minus the volume of MVNRLM diesel
fuel owned at the beginning of the compliance period,
including accounting for any corrections in inventory due to
volume swell or shrinkage, difference in measurement
calibration between receiving and delivering meters, and
similar matters, where corrections that increase inventory are
defined as positive.
[[Page 157]]
(i) If MVNRLMBAL is greater than 0, an RVO is incurred by
the redesignating party for the volume of diesel fuel equal to MVNRLM.
The redesignating party must also comply with all of the following:
(A) The reporting requirements of Sec. 80.1451(a)(1)(xix).
(B) The recordkeeping requirements of Sec. 80.1454(o).
(C) The attest engagement requirements of Sec. Sec. 80.1464 and
80.1475, as applicable.
(ii) If MVNRLMBAL is less than or equal to 0, no RVO is
incurred by the redesignating party for any redesignated certified NTDF.
These parties must comply with all of the following:
(A) The reporting requirements of Sec. 80.1451(i).
(B) The recordkeeping requirements of Sec. 80.1454(o).
(b) Parties that incur an RVO under paragraph (a)(2)(i) of this
section must comply with all applicable requirements for obligated
parties under this subpart.
(c) The provisions of this section do not apply to gasoline or
diesel fuel that is designated for export.
[85 FR 7074, Feb. 6, 2020, as amended at 87 FR 39661, July 1, 2022]
Sec. Sec. 80.1409-80.1414 [Reserved]
Sec. 80.1415 How are equivalence values assigned to renewable fuel?
(a)(1) Each gallon of a renewable fuel, or gallon equivalent
pursuant to paragraph (b)(5) or (b)(6) of this section, shall be
assigned an equivalence value by the producer or importer pursuant to
paragraph (b) or (c) of this section.
(2) The equivalence value is a number that is used to determine how
many gallon-RINs can be generated for a gallon of renewable fuel
according to Sec. 80.1426.
(b) Equivalence values shall be assigned for certain renewable fuels
as follows:
(1) Ethanol which is denatured shall have an equivalence value of
1.0.
(2) Biodiesel shall have an equivalence value of 1.5.
(3) Butanol shall have an equivalence value of 1.3.
(4) Non-ester renewable diesel with a lower heating value of at
least 123,500 Btu/gal shall have an equivalence value of 1.7.
(5) 77,000 Btu LHV of renewable CNG/LNG or RNG shall represent one
gallon of renewable fuel with an equivalence value of 1.0.
(6) 22.6 kWh of electricity shall represent one gallon of renewable
fuel with an equivalence value of 1.0.
(7) For all other renewable fuels, a producer or importer must
submit an application to EPA for an equivalence value following the
provisions of paragraph (c) of this section. A producer or importer may
also submit an application for an alternative equivalence value pursuant
to paragraph (c) of this section if the renewable fuel is listed in this
paragraph (b), but the producer or importer has reason to believe that a
different equivalence value than that listed in this paragraph (b) is
warranted.
(c) Calculation of new equivalence values. (1) The equivalence value
for renewable fuels described in paragraph (b)(7) of this section shall
be calculated using the following formula:
EqV = (R/0.972) * (EC/77,000)
Where:
EqV = Equivalence Value for the renewable fuel, rounded to the nearest
tenth.
R = Renewable content of the renewable fuel. This is a measure of the
portion of a renewable fuel that came from renewable biomass,
expressed as a fraction, on an energy basis.
EC = Energy content of the renewable fuel, in Btu per gallon (lower
heating value).
(2) The application for an equivalence value shall include a
technical justification that includes all the following:
(i) A calculation for the requested equivalence value according to
the equation in paragraph (c)(1) of this section, including supporting
documentation for the value of EC used in the calculation such as a
certificate of analysis from a laboratory that verifies the lower
heating value in Btu per gallon of the renewable fuel produced.
(ii) For each feedstock, biointermediate, component, or additive
that is used to make the renewable fuel, provide a description, the
percent input, and identify whether or not it is renewable biomass or is
produced from renewable biomass.
[[Page 158]]
(iii) For each feedstock or biointermediate that also qualifies as a
renewable fuel, state whether or not RINs have been previously generated
for such feedstock.
(iv) A description of the renewable fuel and the production process,
including a block diagram that shows all inputs and outputs at each step
of the production process with a sample quantity of all inputs and
outputs for one batch of renewable fuel produced.
(3) The Agency will review the technical justification and assign an
appropriate equivalence value to the renewable fuel based on the
procedure in this paragraph (c).
(4) Applications for equivalence values must be sent to the
attention of ``RFS2 Program (Equivalence Value Application)'' to the
address in Sec. 80.10(a).
(5) All applications required under this section shall be submitted
on forms and following procedures prescribed by EPA.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26037, May 10, 2010; 77
FR 1355, Jan. 9, 2012; 79 FR 42159, July 18, 2014; 85 FR 7075, Feb. 6,
2020; 87 FR 39661, July 1, 2022; 88 FR 44581, July 12, 2023]
Sec. 80.1416 Petition process for evaluation of new renewable fuels
pathways.
(a) Pursuant to this section, a party may petition EPA to assign a D
code for their renewable fuel if any of the following apply:
(1) The renewable fuel pathway has not been evaluated by EPA to
determine if it qualifies for a D code pursuant to Sec. 80.1426(f).
(2) The renewable fuel pathway has been determined by EPA not to
qualify for a D code pursuant to Sec. 80.1426(f) and the party can
document significant differences between their fuel production processes
and the fuel production processes already considered by EPA.
(3) The renewable fuel pathway has been determined to qualify for a
certain D code pursuant to Sec. 80.1426(f) and the party can document
significant differences between their fuel production processes and the
fuel production processes already considered by EPA that may qualify
their fuel pathway for a different D code.
(b)(1) Any petition under paragraph (a) of this section shall
include all the following:
(i) The information specified under 40 CFR 1090.805.
(ii) A technical justification that includes a description of the
renewable fuel, feedstock(s), and biointermediate(s) used to make it,
and the production process. The justification must include process
modeling flow charts.
(iii) A mass balance for the pathway, including feedstocks and
biointermediates, fuels produced, co-products, and waste materials
production.
(iv) Information on co-products, including their expected use and
market value.
(v) An energy balance for the pathway, including a list of any
energy and process heat inputs and outputs used in the pathway,
including such sources produced off site or by another entity.
(vi) Any other relevant information, including information
pertaining to energy saving technologies or other process improvements.
(vii) EPA may ask for additional information to complete the
lifecycle greenhouse gas assessment of the new fuel or pathway.
(2) For those companies who use a feedstock not previously evaluated
by EPA under this subpart, the petition must include all the following
in addition to the requirements in paragraph (b)(1) of this section:
(i) Type of feedstock and description of how it meets the definition
of renewable biomass.
(ii) Market value of the feedstock.
(iii) List of other uses for the feedstock.
(iv) List of chemical inputs needed to produce the renewable biomass
source of the feedstock and prepare the renewable biomass for processing
into feedstock.
(v) Identify energy needed to obtain the feedstock and deliver it to
the facility. If applicable, identify energy needed to plant and harvest
the renewable biomass source of the feedstock and modify the source to
create the feedstock.
(vi) Current and projected quantities of the feedstock that will be
used to
[[Page 159]]
produce the fuel, including information on current and projected yields
for feedstocks that are harvested or collected.
(vii) EPA may ask for additional information to complete the
lifecycle Greenhouse Gas assessment of the new fuel or pathway.
(c)(1) A company may only submit one petition per pathway. If EPA
determines the petition to be incomplete, then the company may resubmit.
(2) The petition must be signed and certified as meeting all the
applicable requirements of this subpart by the responsible corporate
officer of the applicant company.
(3) If EPA determines that the petition is incomplete then EPA will
notify the applicant in writing that the petition is incomplete and will
not be reviewed further. However, an amended petition that corrects the
omission may be re-submitted for EPA review.
(4) If the fuel or pathway described in the petition does not meet
the definition of renewable fuel, advanced biofuel, cellulosic biofuel,
or biomass-based diesel, then EPA will notify the applicant in writing
that the petition is denied and will not be reviewed further.
(d) A D code must be approved prior to the generation of RINs for
the fuel in question. During petition review EPA will evaluate whether a
feedstock meets the 75% cellulosic content threshold allowing cellulosic
RINs to be generated for the entire fuel volume produced. EPA may ask
for additional information to complete this evaluation.
(e) The petition under this section shall be submitted on forms and
following procedures as prescribed by EPA.
[75 FR 26037, May 10, 2010, as amended at 79 FR 42160, July 18, 2014; 85
FR 78467, Dec. 4, 2020; 87 FR 39662, July 1, 2022; 88 FR 44582, July 12,
2023]
Sec. Sec. 80.1417-80.1424 [Reserved]
Sec. 80.1425 Renewable Identification Numbers (RINs).
RINs generated on or after July 1, 2010 shall not be generated as a
38-digit code, but shall be identified by the information specified in
paragraphs (a) through (i) of this section and introduced into EMTS as
data elements during the generation of RINs pursuant to Sec.
80.1452(b). For RINs generated prior to July 1, 2010, each RIN is a 38-
digit code of the following form:
KYYYYCCCCFFFFFBBBBBRRD
SSSSSSSSEEEEEEEE
(a) K is a number identifying the type of RIN as follows:
(1) K has the value of 1 when the RIN is assigned to a volume of
renewable fuel pursuant to Sec. 80.1426(e) and Sec. 80.1428(a).
(2) K has the value of 2 when the RIN has been separated from a
volume of renewable fuel pursuant to Sec. 80.1429.
(b) YYYY is the calendar year in which the RIN was generated.
(c) CCCC is the registration number assigned, according to Sec.
80.1450, to the producer or importer of the batch of renewable fuel.
(d) FFFFF is the registration number assigned, according to Sec.
80.1450, to the facility at which the batch of renewable fuel was
produced or imported.
(e) BBBBB is a serial number assigned to the batch which is chosen
by the producer or importer of the batch such that no two batches have
the same value in a given calendar year.
(f) RR is a number representing 10 times the equivalence value of
the renewable fuel as specified in Sec. 80.1415.
(g) D is a number determined according to Sec. 80.1426(f) and
identifying the type of renewable fuel, as follows:
(1) D has the value of 3 to denote fuel categorized as cellulosic
biofuel.
(2) D has the value of 4 to denote fuel categorized as biomass-based
diesel.
(3) D has the value of 5 to denote fuel categorized as advanced
biofuel.
(4) D has the value of 6 to denote fuel categorized as renewable
fuel.
(5) D has the value of 7 to denote fuel categorized as cellulosic
diesel.
(h) SSSSSSSS is a number representing the first gallon-RIN
associated with a batch of renewable fuel.
(i) EEEEEEEE is a number representing the last gallon-RIN associated
with a volume of renewable fuel.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 79977, Dec. 21, 2010]
[[Page 160]]
Sec. 80.1426 How are RINs generated and assigned to batches of renewable
fuel?
(a) General requirements. (1) Renewable fuel producers, importers of
renewable fuel, and other parties allowed to generate RINs under this
part may only generate RINs to represent renewable fuel if they meet the
requirements of paragraphs (b) and (c) of this section and if all the
following occur:
(i) The fuel qualifies for a D code pursuant to Sec. 80.1426(f), or
the EPA has approved a petition for use of a D code pursuant to Sec.
80.1416.
(ii) The fuel is demonstrated to be produced from renewable biomass
pursuant to the reporting requirements of Sec. 80.1451 and the
recordkeeping requirements of Sec. 80.1454.
(A) Feedstocks meeting the requirements of renewable biomass through
the aggregate compliance provision at Sec. 80.1454(g) are deemed to be
renewable biomass.
(B) [Reserved]
(iii) The fuel was produced in compliance with the registration
requirements of Sec. 80.1450, the reporting requirements of Sec.
80.1451, the recordkeeping requirements of Sec. 80.1454, all conditions
set forth in an approval document for a pathway petition submitted under
Sec. 80.1416, and all other applicable regulations of this subpart M.
(iv) The fuel is designated on a product transfer document (PTD) for
use as transportation fuel, heating oil, or jet fuel in accordance with
Sec. 80.1453(a)(12).
(2) To generate RINs for imported renewable fuel, including any
renewable fuel contained in imported transportation fuel, heating oil,
or jet fuel, importers must obtain information from a non-RIN-generating
foreign renewable fuel producer that is registered pursuant to Sec.
80.1450 sufficient to make the appropriate determination regarding the
applicable D code and compliance with the renewable biomass definition
for each imported batch for which RINs are generated.
(3) A party generating a RIN shall specify the appropriate numerical
values for each component of the RIN in accordance with the provisions
of Sec. 80.1425(a) and paragraph (f) of this section.
(4) Where a feedstock or biointermediate is used to produce
renewable fuel and is not entirely renewable biomass, RINs may only be
generated for the portion of fuel that is derived from renewable
biomass, as calculated under paragraph (f)(4) of this section.
(b) Regional applicability. (1) Except as provided in paragraph (c)
of this section, a RIN may only be generated by a renewable fuel
producer or importer for a batch of renewable fuel that satisfies the
requirements of paragraph (a)(1) of this section if it is produced or
imported for use as transportation fuel, heating oil, or jet fuel in the
covered location.
(2) If the Administrator approves a petition of Alaska or a United
States territory to opt-in to the renewable fuel program under the
provisions in Sec. 80.1443, then the requirements of paragraph (b)(1)
of this section shall also apply to renewable fuel produced or imported
for use as transportation fuel, heating oil, or jet fuel in that state
or territory beginning in the next calendar year.
(c) Cases in which RINs are not generated. (1) No person may
generate RINs for fuel that does not satisfy the requirements of
paragraph (a)(1) of this section.
(2) A party must not generate RINs for renewable fuel that is not
produced for use in the covered location.
(3) [Reserved]
(4) Importers shall not generate RINs for renewable fuel imported
from a non-RIN-generating foreign renewable fuel producer unless the
foreign renewable fuel producer is registered with EPA as required in
Sec. 80.1450.
(5) Importers shall not generate RINs for renewable fuel that has
already been assigned RINs by a RIN-generating foreign renewable fuel
producer.
(6) A party is prohibited from generating RINs for a volume of fuel
that it produces if the fuel has been produced by a process that uses a
renewable fuel as a feedstock, and the renewable fuel that is used as a
feedstock was produced by another party, except that RINs may be
generated for such fuel if allowed by the EPA in response to a petition
submitted pursuant to Sec. 80.1416 and the petition approval specifies
a mechanism to prevent double counting
[[Page 161]]
of RINs or where RINs are generated for RNG.
(7) For renewable fuel oil that is heating oil as defined in
paragraph (2) of the definition of heating oil in Sec. 80.2, renewable
fuel producers and importers shall not generate RINs unless they have
received affidavits from the final end user or users of the fuel oil as
specified in Sec. 80.1451(b)(1)(ii)(T)(2).
(8) RINs must not be generated for a biointermediate.
(d)(1) Definition of batch. For the purposes of this section and
Sec. 80.1425, a ``batch of renewable fuel'' is a volume of renewable
fuel that has been assigned a unique identifier within a calendar year
by the producer or importer of the renewable fuel in accordance with the
provisions of this section and Sec. 80.1425. Biogas producers and RNG
producers must use the definitions of batch for biogas and RNG in
Sec. Sec. 80.105(j) and 80.110(j), respectively.
(i) The number of gallon-RINs generated for a batch of renewable
fuel may not exceed 99,999,999.
(ii) A batch of renewable fuel cannot represent renewable fuel
produced or imported in excess of one calendar month.
(2) Multiple gallon-RINs generated to represent a given volume of
renewable fuel can be represented by a single batch-RIN through the
appropriate designation of the RIN volume codes SSSSSSSS and EEEEEEEE.
(i) The value of SSSSSSSS in the batch-RIN shall be 00000001 to
represent the first gallon-RIN associated with the volume of renewable
fuel.
(ii) The value of EEEEEEEE in the batch-RIN shall represent the last
gallon-RIN associated with the volume of renewable fuel, based on the
RIN volume VRIN determined pursuant to paragraph (f) of this
section.
(iii) Under Sec. 80.1452, RIN volumes will be managed by EMTS. RIN
codes SSSSSSSS and EEEEEEEE do not have a role in EMTS.
(e) Assignment of RINs to batches. (1) Except as provided in
paragraph (g) of this section for delayed RINs, the producer or importer
of renewable fuel must assign all RINs generated from a specific batch
of renewable fuel to that batch of renewable fuel.
(2) A RIN is assigned to a volume of renewable fuel when ownership
of the RIN is transferred along with the transfer of ownership of the
volume of renewable fuel, pursuant to Sec. 80.1428(a).
(3) All assigned RINs shall have a K code value of 1.
(f) Generation of RINs--(1) Applicable pathways. (i) D codes must be
used in RINs generated by producers or importers of renewable fuel
according to approved pathways or as specified in paragraph (f)(6) of
this section.
(ii) In choosing an appropriate D code, producers and importers may
disregard any incidental, de minimis feedstock contaminants that are
impractical to remove and are related to customary feedstock production
and transport.
(iii) Tables 1 and 2 to this section do not apply to, and impose no
requirements with respect to, volumes of fuel for which RINs are
generated pursuant to paragraph (f)(6) of this section.
(iv) Pathways in Table 1 to this section and advanced technologies
in Table 2 to this section also apply in cases where the renewable fuel
producer is using a biointermediate.
(v) For the purposes of identifying the appropriate pathway in Table
1 to this section, biointermediates used for the production of renewable
fuel are considered to be equivalent to the renewable biomass from which
they were derived, with the following exceptions:
(A) Oil that is physically separated from any woody or herbaceous
biomass and used to produce renewable fuel shall not generate D-code 3
or 7 RINs.
(B) Sugar or starch that is physically separated from cellulosic
biomass and used to produce renewable fuel shall not generate D-code 3
or 7 RINs.
(vi) If a renewable fuel producer uses a biointermediate for the
production of renewable fuel, additional requirements apply to both the
renewable fuel producer and the biointermediate producer as described in
Sec. 80.1476.
(2) Renewable fuel that can be described by a single pathway. (i)
The number of gallon-RINs that shall be generated for a batch of
renewable fuel by a producer or importer for renewable fuel that can be
described by a single pathway shall be equal to a volume calculated
according to the following formula:
[[Page 162]]
VRIN = EqV * Vs
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
Vs = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
(ii) The D code that shall be used in the RINs generated shall be
the D code specified in the approved pathway that corresponds to the
pathway that describes the producer's operations.
(3) Renewable fuel that can be described by two or more pathways.
(i) The D codes that shall be used in the RINs generated by a producer
or importer whose renewable fuel can be described by two or more
pathways shall be the D codes specified in the approved pathways that
correspond to the pathways that describe the renewable fuel throughout
that calendar year.
(ii) If all the pathways describing the producer's operations have
the same D code and each batch is of a single fuel type, then that D
code shall be used in all the RINs generated and the number of gallon-
RINs that shall be generated for a batch of renewable fuel shall be
equal to a volume calculated according to the following formula:
VRIN = EqV * Vs
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
Vs = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
(iii) If all the pathways describing the producer's operations have
the same D code but individual batches are comprised of a mixture of
fuel types with different equivalence values, then that D code shall be
used in all the RINs generated and the number of gallon-RINs that shall
be generated for a batch of renewable fuel shall be equal to a volume
calculated according to the following formula:
VRIN = [Sigma](EqVi * Vs,i)
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for the batch.
EqVi = Equivalence value for fuel type i in the batch of
renewable fuel per Sec. 80.1415.
Vs,i = Standardized volume of fuel type i in the batch of
renewable fuel at 60 [deg]F, in gallons, calculated in accordance with
paragraph (f)(8) of this section.
(iv) If the pathway applicable to a producer changes on a specific
date, such that one pathway applies before the date and another pathway
applies on and after the date, and each batch is of a single fuel type,
then the applicable D code and batch identifier used in generating RINs
must change on the date that the change in pathway occurs and the number
of gallon-RINs that shall be generated for a batch of renewable fuel
shall be equal to a volume calculated according to the following
formula:
VRIN = EqV * Vs
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for a batch with
a single applicable D code.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
Vs = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
(v) If a producer produces batches that are comprised of a mixture
of fuel types with different equivalence values and different applicable
D codes, then separate values for VRIN must be calculated for
each category of renewable fuel according to the following formula. All
batch-RINs thus generated must be assigned to unique batch identifiers
for each portion of the batch with a different D code.
VRIN,DX = EqVDX * VS,DX
Where:
VRIN,DX = RIN volume, in gallons, for use in determining the
number of gallon-RINs that must be generated for the portion
of the batch with a D code of X.
EqVDX = Equivalence value for the portion of the batch with a
D code of X, per Sec. 80.1415.
VS,DX = Standardized volume at 60 [deg]F of the portion of
the batch that must be assigned a D code of X, in gallons, per
paragraph (f)(8) of this section.
[[Page 163]]
(vi)(A) If a producer produces a single type of renewable fuel using
two or more different feedstocks that are processed simultaneously, and
each batch is comprised of a single type of fuel, then the number of
gallon-RINs that must be generated for a batch of renewable fuel and
assigned a particular D code must be calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR12JY23.012
Where:
VRIN,DX = RIN volume, in gallons, for use in determining the
number of gallon-RINs that must be generated for a batch of
renewable fuel with a D code of X.
EqV = Equivalence value for the renewable fuel per Sec. 80.1415.
VS = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, per paragraph (f)(8) of this section.
FEDX = The total feedstock energy from all feedstocks whose
pathways have been assigned a D code of X, in Btu HHV, per
paragraphs (f)(3)(vi)(B) and (C) of this section.
FEtotal = The total feedstock energy from all feedstocks, in
Btu HHV, per paragraphs (f)(3)(vi)(B) and (C) of this section.
(B) Except for biogas produced from anaerobic digestion, the
feedstock energy value of each feedstock must be calculated as follows:
FEDX,i = Mi * (1-mi) * CFi
Where:
FEDX,i = The amount of energy from feedstock i that forms
energy in the renewable fuel and whose pathway has been
assigned a D code of X, in Btu HHV.
Mi = Mass of feedstock i, in pounds, measured on a daily or
per-batch basis.
mi = Average moisture content of feedstock i, as a mass
fraction.
CFi = Converted fraction in annual average Btu HHV/lb, except
as otherwise provided by Sec. 80.1451(b)(1)(ii)(U),
representing that portion of feedstock i that is converted to
fuel by the producer.
(C) For biogas produced from anaerobic digestion, the volume of
biogas must be measured under Sec. 80.105(f) and the feedstock energy
value of each feedstock must be calculated as specified in Sec.
80.105(j) by substituting ``feedstock energy'' for ``batch volume of
biogas'' in all cases.
(4) Renewable fuel that is produced by co-processing renewable
biomass (including a biointermediate) and non-renewable feedstocks
simultaneously to produce a fuel that is partially renewable. (i) The
number of gallon-RINs that shall be generated for a batch of partially
renewable fuel shall be equal to a volume VRIN calculated
according to Method A or Method B.
(A) Method A. (1) VRIN shall be calculated according to
the following formula:
VRIN = EqV * Vs * FER/(FER +
FENR)
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415, subject to qualification in paragraph (f)(4)(iii) of
this section.
Vs = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
FER = Feedstock energy from renewable biomass (including the
renewable portion of a biointermediate) used to make the
transportation fuel, in Btu.
FENR = Feedstock energy from non-renewable feedstocks
(including the non-renewable portion of a biointermediate)
used to make the transportation fuel, heating oil, or jet
fuel, in Btu.
(2) The value of FE for use in paragraph (f)(4)(i)(A)(1) of this
section shall be calculated from the following formula:
FE = M * (1 - m) * CF * E
Where:
FE = Feedstock energy, in Btu.
M = Mass of feedstock, in pounds, measured on a daily or per-batch
basis.
m = Average moisture content of the feedstock, in mass percent.
CF = Converted Fraction in annual average mass percent, except as
otherwise provided by Sec. 80.1451(b)(1)(ii)(U), representing
[[Page 164]]
that portion of the feedstock that is converted into
transportation fuel, heating oil, or jet fuel by the producer.
E = Energy content of the components of the feedstock that are converted
to fuel, in annual average Btu/lb, determined according to
paragraph (f)(7) of this section.
(B) Method B. VRIN shall be calculated according to the
following formula:
VRIN = EqV * Vs * R
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415, subject to qualification in paragraph (f)(4)(iii) of
this section.
Vs = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
R = The renewable fraction of the fuel as measured by a carbon-14 dating
test method as provided in paragraph (f)(9) of this section.
(ii) The D code that shall be used in the RINs generated to
represent partially renewable transportation fuel, heating oil, or jet
fuel shall be the D code specified in the approved pathway that
corresponds to the pathway that describes a producer's operations. In
determining the appropriate pathway, the contribution of non-renewable
feedstocks to the production of partially renewable fuel shall be
ignored.
(iii) In determining the RIN volume VRIN according to
paragraph (f)(4)(i)(A) or (f)(4)(i)(B) of this section, the equivalence
value used to determine VRIN which is calculated according to
Sec. 80.1415 shall use a value of 1.0 to represent R, the renewable
content of the renewable fuel.
(iv) RIN-generating parties must calculate RIN volume
VRIN for co-processed fuels produced from a biointermediate
as described in paragraph (f)(4)(i)(B) of this section and calculate the
renewable fraction of a fuel R using one of the following:
(A) Method B of ASTM D6866 (incorporated by reference, see Sec.
80.12) as described in paragraph (f)(9)(ii) of this section.
(B) If the renewable content of the co-processed fuel is 10 percent
or greater, Method C of ASTM D6866 as described in paragraph (f)(9)(ii)
of this section.
(C) Any other EPA-approved method under paragraph (f)(9)(ii) of this
section.
(5) Renewable fuel produced from separated yard waste, separated
food waste, and separated MSW. (i)(A) Separated yard waste is deemed to
be composed entirely of cellulosic materials.
(B) Separated food waste is deemed to be composed entirely of non-
cellulosic materials, unless a party demonstrates that a portion of the
feedstock is cellulosic through approval of their facility registration.
(ii)(A) A feedstock qualifies as separated yard waste or separated
food waste only if it is collected according to a plan submitted to and
accepted by EPA under the registration procedures specified in Sec.
80.1450(b)(1)(vii).
(B) A feedstock qualifies as separated MSW only if it is collected
according to a plan submitted to and approved by EPA.
(iii) Separation and recycling actions for separated MSW are
considered to occur if:
(A) Recyclable paper, cardboard, plastics, rubber, textiles, metals,
and glass that can be recycled are separated and removed from the
municipal solid waste stream to the extent reasonably practicable
according to a plan submitted to and approved by U.S. EPA under the
registration procedures specified in Sec. 80.1450(b)(1)(viii); and
(B) The fuel producer has evidence of all contracts relating to the
disposition of paper, cardboard, plastics, rubber, textiles, metals, and
glass that are recycled.
(iv)(A) The number of gallon-RINs that shall be generated for a
batch of renewable fuel derived from separated yard waste shall be equal
to a volume VRIN and is calculated according to the following
formula:
VRIN = EqV * VS
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of cellulosic biofuel gallon-RINs that shall be
generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
[[Page 165]]
Vs = Standardized volume of the batch of renewable fuel at 60 [deg]F, in
gallons, calculated in accordance with paragraph (f)(8) of
this section.
(B) The number of gallon-RINs that shall be generated for a batch of
renewable fuel derived from separated food waste shall be equal to a
volume VRIN and is calculated according to the following
formula:
VRIN = EqV * VS
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of cellulosic or advanced biofuel gallon-RINs that
shall be generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
VS = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
(v) The number of cellulosic biofuel gallon-RINs that shall be
generated for the cellulosic portion of a batch of renewable fuel
derived from separated MSW shall be determined according to the
following formula:
VRIN = EqV * VS * R
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of cellulosic biofuel gallon-RINs that shall be
generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
VS = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
R = The calculated non-fossil fraction of the fuel as measured by a
carbon-14 dating test method as provided in paragraph (f)(9)
of this section, except that for biogas-derived renewable fuel
made from separated MSW, no testing is required and R = 1.
(6) Renewable fuel not covered by an approved pathway. If no
approved pathway applies to a producer's operations, the party may
generate RINs if the fuel from its facility is produced from renewable
biomass and qualifies for an exemption under Sec. 80.1403 from the
requirement that renewable fuel achieve at least a 20 percent reduction
in lifecycle greenhouse gas emissions compared to baseline lifecycle
greenhouse gas emissions.
(i) The number of gallon-RINs that shall be generated for a batch of
renewable fuel that qualifies for an exemption from the 20 percent GHG
reduction requirements under Sec. 80.1403 shall be equal to a volume
calculated according to the following formula:
VRIN = EqV * Vs
Where:
VRIN = RIN volume, in gallons, for use in determining the
number of gallon-RINs that shall be generated for the batch.
EqV = Equivalence value for the batch of renewable fuel per Sec.
80.1415.
Vs = Standardized volume of the batch of renewable fuel at 60
[deg]F, in gallons, calculated in accordance with paragraph
(f)(8) of this section.
(ii) A D code of 6 shall be used in the RINs generated under this
paragraph (f)(6).
(7) Determination of feedstock energy content factors.(i) For
purposes of paragraphs (f)(3)(vi) and (f)(4)(i)(A)(2) of this section,
producers must specify the value for E, the energy content of the
components of the feedstock that are converted to renewable fuel, used
in the calculation of the feedstock energy value FE.
(ii) The value for E shall represent the higher or gross calorific
heating value for a feedstock on a zero moisture basis.
(iii) Producers must specify the value for E for each type of
feedstock at least once per calendar year.
(iv) A producer must use default values for E as provided in
paragraph (f)(7)(vi) of this section, or must determine alternative
values for its own feedstocks according to paragraph (f)(7)(v) of this
section.
(v) Producers that do not use a default value for E must use the
following test methods, or alternative test methods as approved by EPA,
to determine the value of E. The value of E shall be based upon the test
results of a sample of feedstock that, based upon good engineering
judgment, is representative of the feedstocks used to produce renewable
fuel:
(A) ASTM E870 or ASTM E711 for gross calorific value (both
incorporated by reference, see Sec. 80.12).
(B) ASTM D4442 or ASTM D4444 for moisture content (both incorporated
by reference, see Sec. 80.12).
[[Page 166]]
(vi) Default values for E.
(A) Starch: 7,600 Btu/lb.
(B) Sugar: 7,300 Btu/lb.
(C) Vegetable oil: 17,000 Btu/lb.
(D) Waste cooking oil or trap grease: 16,600 Btu/lb.
(E) Tallow or fat: 16,200 Btu/lb.
(F) Manure: 6,900 Btu/lb.
(G) Woody biomass: 8,400 Btu/lb.
(H) Herbaceous biomass: 7,300 Btu/lb.
(I) Yard wastes: 2,900 Btu/lb.
(J) Biogas: 11,000 Btu/lb.
(K) Food waste: 2,000 Btu/lb.
(L) Paper: 7,200 Btu/lb.
(M) Crude oil: 19,100 Btu/lb.
(N) Coal--bituminous: 12,200 Btu/lb.
(O) Coal--anthracite: 13,300 Btu/lb.
(P) Coal--lignite or sub-bituminous: 7,900 Btu/lb.
(Q) Natural gas: 19,700 Btu/lb.
(R) Tires or rubber: 16,000 Btu/lb.
(S) Plastic: 19,000 Btu/lb.
(8) Standardization of volumes. In determining the standardized
volume of a batch of renewable fuel for purposes of generating RINs
under this paragraph (f), the batch volumes shall be adjusted to a
standard temperature of 60 [deg]F.
(i) For ethanol, the following formula shall be used:
Vs,e = Va,e * (-0.0006301 * T + 1.0378)
Where:
Vs,e = Standardized volume of ethanol at 60 [deg]F, in
gallons.
Va,e = Actual volume of ethanol, in gallons.
T = Actual temperature of the batch, in [deg]F.
(ii) For biodiesel, one of the following two methods for biodiesel
temperature standardization to 60 [deg]Fahrenheit ([deg]F) shall be used
(A) Vs,b = Va.b * (-0.00045767 * T + 1.02746025)
Where
Vs,b = Standardized volume of biodiesel at 60 [deg]F, in
gallons.
Va,b = Actual volume of biodiesel, in gallons.
T = Actual temperature of the batch, in [deg]F.
(B) The standardized volume of biodiesel at 60 [deg]F, in gallons,
as calculated from the use of the American Petroleum Institute Refined
Products Table 6B, as referenced in ASTM D1250 (incorporated by
reference, see Sec. 80.12).
(iii) For other renewable fuels, an appropriate formula commonly
accepted by the industry shall be used to standardize the actual volume
to 60 [deg]F. Formulas used must be reported to EPA, and may be
determined to be inappropriate.
(9) Use of radiocarbon dating test methods.(i) Parties may use a
radiocarbon dating test method for determination of the renewable
fraction of a fuel R used to determine VRIN as provided in
paragraphs (f)(4) and (f)(5) of this section.
(ii) Parties must use Method B or Method C of ASTM D6866
(incorporated by reference, see Sec. 80.12), or an alternative test
method as approved by EPA.
(iii) For each batch of fuel, the value of R must be based on:
(A) A radiocarbon dating test of the batch of fuel produced; or
(B) A radiocarbon dating test of a composite sample of previously
produced fuel, if all of the following conditions are met:
(1) Based upon good engineering judgment, the renewable fraction of
the composite sample must be representative of the batch of fuel
produced.
(2) The composite sample is comprised of a volume weighted
combination of samples from every batch of partially renewable
transportation fuel produced by the party over a period not to exceed
one calendar month, or more frequently if necessary to ensure that the
test results are representative of the renewable fraction of the
partially renewable fuel.
(3) The composite sample must be well mixed prior to testing.
(4) A volume of each composite sample must be retained for a minimum
of two years, and be of sufficient volume to permit two additional tests
to be conducted.
(iv) If the party is using the composite sampling approach according
to paragraph (f)(9)(iii)(B) of this section, the party may estimate the
value of R for use in generating RINs in the first month if all of the
following conditions are met:
(A) The estimate of R for the first month is based on information on
the composition of the feedstock;
(B) The party calculates R in the second month based on the
application of a radiocarbon dating test on a composite sample pursuant
to (f)(9)(iii)(B) of this section; and
[[Page 167]]
(C) The party adjusts the value of R used to generate RINs in the
second month using the following formula
Ri + 1,adj = 2 x Ri + 1,calc-Ri,est
Where
Ri + 1,adj = Adjusted value of R for use in generating RINs
in month the second month i + 1.
Ri + 1,calc = Calculated value of R in second month i + 1 by
applying a radiocarbon dating test method to a composite
sample of fuel.
Ri,est = Estimate of R for the first month i.
(10)(i) For purposes of this section, electricity that is only
distributed via a closed, private, non-commercial system is considered
renewable fuel and RINs may be generated if all of the following apply:
(A) The electricity is produced from renewable biomass and qualifies
for a D code in Table 1 to this section or has received approval for use
of a D code by EPA.
(B) The RIN generator has documentation for the sale, if applicable,
and use of a specific quantity of renewable electricity as
transportation fuel, or has obtained affidavits from all parties selling
or using the electricity as transportation fuel.
(C) The electricity is used as a transportation fuel and for no
other purposes.
(ii) RIN generators may only generate RINs for renewable CNG/LNG
produced from biogas that is distributed via a closed, private, non-
commercial system if all the following requirements are met:
(A) The renewable CNG/LNG was produced from renewable biomass under
an approved pathway.
(B) The RIN generator has entered into a written contract for the
sale or use of a specific quantity of renewable CNG/LNG for use as
transportation fuel, or has obtained affidavits from all parties selling
or using the renewable CNG/LNG as transportation fuel.
(C) The renewable CNG/LNG was used as transportation fuel and for no
other purpose.
(D) The biogas was introduced into the closed, private, non-
commercial system no later and the renewable CNG/LNG produced from the
biogas was used as transportation fuel no later than December 31, 2024.
(E) RINs may only be generated on biomethane content of the
renewable CNG/LNG used as transportation fuel.
(iii) A producer of electricity that is generated by co-firing a
combination of renewable biomass and fossil fuel may generate RINs only
for the portion attributable to the renewable biomass, using the
procedure described in paragraph (f)(4) of this section.
(11)(i) For purposes of this section, electricity that is introduced
into a commercial distribution system (transmission grid) is considered
renewable fuel for which RINs may be generated if all of the following
apply:
(A) The electricity is produced from renewable biomass and qualifies
for a D code in Table 1 of this section or has received approval for use
of a D code by EPA.
(B) The RIN generator has documentation for the sale and use of a
specific quantity of renewable electricity as transportation fuel, or
has obtained affidavits from all parties selling or using the
electricity as transportation fuel.
(C) The quantity of electricity for which RINs were generated was
sold for use as transportation fuel and for no other purpose.
(D) The renewable electricity was loaded onto and withdrawn from a
physically connected transmission grid.
(E) The amount of electricity sold for use as transportation fuel
corresponds to the amount of electricity derived from biogas that was
placed into the commercial distribution system.
(F) No other party relied upon the renewable electricity for the
creation of RINs.
(ii) RINs for renewable CNG/LNG produced from RNG that is introduced
into a commercial distribution system may only be generated if all the
following requirements are met:
(A) The renewable CNG/LNG was produced from renewable biomass and
qualifies for a D code in an approved pathway.
(B) The RIN generator has entered into a written contract for the
sale or use of a specific quantity of RNG, taken from a commercial
distribution system (e.g., physically connected pipeline, barge, truck,
rail), for use as
[[Page 168]]
transportation fuel, or has obtained affidavits from all parties selling
or using the RNG taken from a commercial distribution system as
transportation fuel.
(C) The renewable CNG/LNG produced from the RNG was sold for use as
transportation fuel and for no other purpose.
(D) The RNG was injected into and withdrawn from the same commercial
distribution system.
(E) The RNG was withdrawn from the commercial distribution system in
a manner and at a time consistent with the transport of the RNG between
the injection and withdrawal points.
(F) The volume of RNG injected into the commercial distribution
system and the volume of RNG withdrawn are measured by continuous
metering.
(G) The volume of renewable CNG/LNG sold for use as transportation
fuel corresponds to the volume of RNG that was injected into and
withdrawn from the commercial distribution system.
(H) No other party relied upon the volume of biogas, RNG, or
renewable CNG/LNG for the generation of RINs.
(I) The RNG was introduced into the commercial distribution system
no later than December 31, 2024, and the renewable CNG/LNG was used as
transportation fuel no later than December 31, 2024.
(J) RINs may only be generated on biomethane content of the biogas,
treated biogas, RNG, or renewable CNG/LNG.
(K)(1) On or after January 1, 2025, RINs may only be generated for
RNG injected into a natural gas commercial pipeline system for use as
transportation fuel as specified in subpart E of this part.
(2) RINs may be generated for RNG as specified in subpart E of this
part prior to January 1, 2025, if all applicable requirements under this
part are met.
(iii) For renewable electricity that is generated by co-firing a
combination of renewable biomass and fossil fuel, the producer may
generate RINs only for the portion attributable to the renewable
biomass, using the procedure described in paragraph (f)(4) of this
section.
(12) Process heat produced from combustion of biogas or RNG at a
renewable fuel production facility is considered ``derived from
biomass'' under an approved pathway if all the following requirements
are met, as applicable:
(i) For biogas transported to the renewable fuel production facility
via a biogas closed distribution system:
(A) The renewable fuel producer has entered into a written contract
for the procurement of a specific volume of biogas with a specific heat
content.
(B) The volume of biogas was sold to the renewable fuel production
facility, and to no other facility.
(C) The volume of biogas injected into the biogas closed
distribution system and the volume of biogas used as process heat were
measured under Sec. 80.155.
(ii) For RNG injected into a natural gas commercial pipeline system
prior to July 1, 2024:
(A) The producer has entered into a written contract for the
procurement of a specific volume of RNG with a specific heat content.
(B) The volume of RNG was sold to the renewable fuel production
facility, and to no other facility.
(C) The volume of RNG was withdrawn from the natural gas commercial
pipeline system in a manner and at a time consistent with the transport
of RNG between the injection and withdrawal points.
(D) The volume of RNG injected into the natural gas commercial
pipeline system and the volume of RNG withdrawn were measured under
Sec. 80.155.
(E) The natural gas commercial pipeline system into which the RNG
was injected ultimately serves the renewable fuel production facility.
(iii) Process heat produced from combustion of biogas or RNG is not
considered produced from renewable biomass if any other party relied
upon the volume of biogas or RNG for the generation of RINs.
(iv) For RNG used as process heat on or after July 1, 2024, the
renewable fuel producer must retire RINs for RNG as specified in Sec.
80.125(e).
(13) In order for a renewable fuel production facility to satisfy
the requirements of the advanced biofuel grain
[[Page 169]]
sorghum pathway, all the following requirements must be met:
(i) The quantity of electricity used at the site that is purchased
from the grid must be measured and recorded by continuous metering.
(ii) All electricity used on-site that is not purchased from the
grid must be produced on-site from biogas from landfills, waste
treatment plants, and/or waste digesters.
(iii) For biogas transported to the renewable fuel production
facility via a biogas closed distribution system and used as process
energy, the requirements in paragraph (f)(12)(i) of this section must be
met.
(iv)(A) For RNG injected into a commercial distribution system prior
to July 1, 2024, and used as process energy, the requirements in
paragraph (f)(12)(ii) of this section must be met.
(B) For RNG injected into a natural gas commercial pipeline system
on or after July 1, 2024, and used as process energy, the renewable fuel
producer must retire RINs for RNG as specified in Sec. 80.125(e).
(v) The biogas or RNG used as process energy at the renewable fuel
production facility is not considered ``produced from renewable
biomass'' under an approved pathway if any other party relied upon the
volume of biogas or RNG for the generation of RINs.
(14) A producer or importer of renewable fuel using giant reed
(Arundo donax) or napier grass (Pennisetum purpureum) as a feedstock may
generate RINs for that renewable fuel if:
(i) The feedstock is produced, managed, transported, collected,
monitored, and processed according to a Risk Mitigation Plan approved by
EPA under the registration procedures specified in Sec.
80.1450(b)(1)(x)(A); or,
(ii) EPA has determined that there is not a significant likelihood
of spread beyond the planting area of the feedstock used for production
of the renewable fuel. Any determination that Arundo donax or Pennisetum
purpureum does not present a significant likelihood of spread beyond the
planting area must be based upon clear and compelling evidence,
including information and supporting data submitted by the producer.
Such a determination must be made by EPA as specified in Sec.
80.1450(b)(1)(x)(B).
(15) Application of formulas in paragraph (f)(3)(vi) of this section
to certain producers generating D3 or D7 RINs. If a producer seeking to
generate D code 3 or 7 RINs produces a single type of renewable fuel
using two or more feedstocks or biointermediates converted
simultaneously, and at least one of the feedstocks or biointermediates
does not have a minimum 75% average adjusted cellulosic content, one of
the following additional requirements apply:
(i) If the producer is using a thermochemical process to convert
cellulosic biomass into cellulosic biofuel, the producer is subject to
additional registration requirements under Sec. 80.1450(b)(1)(xiii)(A).
(ii) If the producer is using any process other than a
thermochemical process, or is using a combination of processes, the
producer is subject to additional registration requirements under Sec.
80.1450(b)(1)(xiii)(B) or (C), and reporting requirements under Sec.
80.1451(b)(1)(ii)(U), as applicable.
(16) Renewable fuel produced from crop residue. Producers generating
RINs for qualifying renewable fuel utilizing crop residue as feedstock
under Pathway K or Pathway L must meet all of the following conditions
(in addition to any other applicable requirements):
(i) Registration requirements under Sec. 80.1450(b)(1)(xv).
(ii) Reporting requirements under Sec. 80.1451(b)(1)(ii)(V).
(iii) Recordkeeping requirements under Sec. 80.1454(n).
(17) Qualifying use demonstration for certain renewable fuels. For
purposes of this section, any renewable fuel other than ethanol,
biodiesel, renewable gasoline, or renewable diesel that meets the Grade
No. 1-D or No. 2-D specification in ASTM D975 (incorporated by
reference, see Sec. 80.12) is considered renewable fuel and the
producer or importer may generate RINs for such fuel only if all the
following apply:
(i) The fuel is produced from renewable biomass and qualifies to
generate RINs under an approved pathway.
(ii) The fuel producer or importer maintains records demonstrating
that the fuel was produced for use as a
[[Page 170]]
transportation fuel, heating oil or jet fuel by any of the following:
(A) Blending the renewable fuel into gasoline or distillate fuel to
produce a transportation fuel, heating oil, or jet fuel that meets all
applicable standards under this part and 40 CFR part 1090.
(B) Entering into a written contract for the sale of the renewable
fuel, which specifies the purchasing party must blend the fuel into
gasoline or distillate fuel to produce a transportation fuel, heating
oil, or jet fuel that meets all applicable standards under this part and
40 CFR part 1090.
(C) Entering into a written contract for the sale of the renewable
fuel, which specifies that the fuel must be used in its neat form as a
transportation fuel, heating oil or jet fuel that meets all applicable
standards.
(ii) The fuel was sold for use in or as a transportation fuel,
heating oil, or jet fuel, and for no other purpose.
(g) Delayed RIN generation. (1) Parties who produce or import
renewable fuel may elect to generate delayed RINs to represent renewable
fuel volumes that have already been transferred to another party if
those renewable fuel volumes meet all of the following requirements.
(i) The renewable fuel volumes can be described by a new approved
pathway that was added after July 1, 2010.
(A) For new pathways that EPA approves in response to petitions
submitted pursuant to Sec. 80.1416, complete petitions must be received
by EPA by January 31, 2011.
(B) [Reserved]
(ii) The renewable fuel volumes can be described by a pathway that:
(A) Is biodiesel that is made from canola oil through
transesterification using natural gas or biomass for process energy; or
(B) EPA has determined was in use as of July 1, 2010, for the
primary purpose of producing transportation fuel, heating oil, or jet
fuel for commercial sale.
(iii) The renewable fuel volumes were not designated or intended for
export from the covered location by the renewable fuel producer or
importer, and the producer or importer of the renewable fuel volumes
does not know or have reason to know that the volumes were exported from
the covered location.
(2) When a new approved pathway is added, EPA will specify in its
approval action the effective date on which the new pathway becomes
valid for the generation of RINs and whether the fuel in question meets
the requirements of paragraph (g)(1)(ii) of this section.
(i) The effective date for the pathway describing biodiesel that is
made from canola oil through transesterification using natural gas or
biomass for process energy is September 28, 2010.
(ii) [Reserved]
(3) Delayed RINs can only be generated to represent renewable fuel
volumes produced in the covered location or imported into the covered
location between July 1, 2010, and the earlier of either of the
following dates:
(i) The effective date (identified pursuant to paragraph (g)(2) of
this section) of the new pathway through which the fuel in question was
produced; or
(ii) December 31, 2011.
(4) Delayed RINs must be generated no later than 60 days after the
effective date (identified pursuant to paragraph (g)(2) of this section)
of the pathway by which the fuel in question was produced.
(5) A party authorized pursuant to paragraph (g)(1) of this section
to generate delayed RINs, and electing to do so, who generated RINs
pursuant to 80.1426(f)(6) for fuel produced through a pathway described
in paragraph (g)(1) of this section, and transferred those RINs with
renewable fuel volumes between July 1, 2010 and the effective date
(identified pursuant to paragraph (g)(2) of this section) of that
pathway, must retire a number of gallon-RINs prior to generating delayed
RINs.
(i) The number of gallon-RINs retired by a party pursuant to this
paragraph must not exceed the number of gallon-RINs originally generated
by the party to represent fuel described in paragraph (g)(1) of this
section that was produced in the covered location or imported into the
covered location, and transferred to another party, between July 1, 2010
and the earlier of either of the following dates:
[[Page 171]]
(A) The effective date (identified pursuant to paragraph (g)(2) of
this section) of the new pathway through which the fuel in question was
produced; or
(B) December 31, 2011.
(ii) Retired RINs must have a D code of 6.
(iii) Retired RINs must have a K code of 2.
(iv) Retired RINs must have been generated in the same year as the
gallon-RINs originally generated by the party to represent fuel
described in paragraph (g)(1) of this section.
(A) For gallon-RINs originally generated in 2010 to represent fuel
described in paragraph (g)(1) of this section, the generation year of
retired RINs shall be 2010.
(B) For gallon-RINs originally generated in 2011 to represent fuel
described in paragraph (g)(1) of this section, the generation year of
retired RINs shall be 2011.
(6) For parties that retire RINs pursuant to paragraph (g)(5) of
this section, the number of delayed gallon-RINs generated shall be equal
to the number of gallon-RINs retired in accordance with paragraph (g)(5)
of this section.
(7) A party authorized pursuant to paragraph (g)(1) of this section
to generate delayed RINs, and electing to do so, who did not generate
RINs pursuant to Sec. 80.1426(f)(6) for renewable fuel produced in the
covered location or imported into the covered location between July 1,
2010 and the effective date (identified pursuant to paragraph (g)(2) of
this section) of a new pathway for the fuel in question, may generate a
number of delayed gallon-RINs for that renewable fuel in accordance with
paragraph (f) of this section.
(i) The standardized volume of fuel (Vs) used by a party
to determine the RIN volume (VRIN) under paragraph (f) of
this section shall be the standardized volume of the fuel described in
paragraph (g)(1)(i) of this section that was produced in the covered
location or imported into the covered location by the party, and
transferred to another party, between July 1, 2010 and the earlier of
either of the following dates:
(A) The effective date (identified pursuant to paragraph (g)(2) of
this section) of the new pathway through which the fuel in question was
produced; or
(B) December 31, 2011.
(ii) [Reserved]
(8) The renewable fuel for which delayed RINs are generated must be
described by a pathway that satisfies the requirements of paragraph
(g)(1) of this section.
(9) All delayed RINs generated by a renewable fuel producer or
importer must be generated within EMTS on the same date.
(10) The generation year of delayed RINs as designated in EMTS shall
be the year that the renewable fuel volumes they represent were either
produced or imported into the covered location.
(i) For renewable fuel volumes produced or imported in 2010, the
generation year of delayed RINs shall be 2010 and the production date
specified in EMTS shall be 07/01/2010.
(ii) For renewable fuel volumes produced or imported in 2011, the
generation year of delayed RINs shall be 2011 and the production date
specified in EMTS shall be 01/01/2011.
(11) Delayed RINs shall be generated as assigned RINs in EMTS with a
batch number that begins with ``DRN'', and then immediately separated by
the RIN generator.
(12) The D code that shall be used in delayed RINs shall be the D
code which corresponds to the new pathway.
(13) Except as provided in this paragraph (g), all other provisions
in this Subpart M that pertain to the identification of fuels for which
RINs may be generated, the generation and use of RINs, and recordkeeping
and reporting, are also applicable to delayed RINs.
[[Page 172]]
Table 1 to Sec. 80.1426--Applicable D Codes for Each Fuel Pathway for Use in Generating RINs
----------------------------------------------------------------------------------------------------------------
Production process
Fuel type Feedstock requirements D-Code
----------------------------------------------------------------------------------------------------------------
A Ethanol................... Corn starch.................... All of the following: Dry mill 6
process, using natural gas,
biomass, or biogas for
process energy and at least
two advanced technologies
from Table 2 to this section.
B Ethanol................... Corn starch.................... All of the following: Dry mill 6
process, using natural gas,
biomass, or biogas for
process energy and at least
one of the advanced
technologies from Table 2 to
this section plus drying no
more than 65% of the
distillers grains with
solubles it markets annually.
C Ethanol................... Corn starch.................... All of the following: Dry mill 6
process, using natural gas,
biomass, or biogas for
process energy and drying no
more than 50% of the
distillers grains with
solubles it markets annually.
D Ethanol................... Corn starch.................... Wet mill process using biomass 6
or biogas for process energy.
E Ethanol................... Starches from crop residue and Fermentation using natural 6
annual covercrops. gas, biomass, or biogas for
process energy.
F Biodiesel, renewable Soy bean oil; Oil from annual One of the following: 4
diesel, jet fuel and covercrops; Oil from algae Transesterification with or
heating oil. grown photosynthetically; without esterification pre-
Biogenic waste oils/fats/ treatment, Esterification, or
greases; Camelina sativa oil; Hydrotreating; excludes
Distillers corn oil; processes that co-process
Distillers sorghum oil; renewable biomass and
Commingled distillers corn oil petroleum.
and sorghum oil.
G Biodiesel, renewable Canola/Rapeseed oil............ One of the following: 4
diesel, jet fuel, and Transesterification using
heating oil. natural gas or biomass for
process energy, or
Hydrotreating; excludes
processes that co-process
renewable biomass and
petroleum.
H Biodiesel, renewable Soy bean oil; Oil from annual One of the following: 5
diesel, jet fuel, and covercrops; Oil from algae Transesterification with or
heating oil. grown photosynthetically; without esterification pre-
Biogenic waste oils/fats/ treatment, Esterification, or
greases; Camelina sativa oil; Hydrotreating; includes only
Distillers corn oil; processes that co-process
Distillers sorghum oil; renewable biomass and
Commingled distillers corn oil petroleum.
and sorghum oil; Canola/
Rapeseed oil.
I Naphtha, LPG.............. Camelina sativa oil; Distillers Hydrotreating................. 5
sorghum oil; Distillers corn
oil; Commingled distillers
corn oil and distillers
sorghum oil; Canola/Rapeseed
oil.
J Ethanol................... Sugarcane...................... Fermentation.................. 5
K Ethanol................... Crop residue, slash, pre- Any process that converts 3
commercial thinnings and tree cellulosic biomass to fuel.
residue, switchgrass,
miscanthus, energy cane,
Arundo donax, Pennisetum
purpureum, and separated yard
waste; biogenic components of
separated MSW; cellulosic
components of separated food
waste; and cellulosic
components of annual cover
crops.
L Cellulosic diesel, jet Crop residue, slash, pre- Any process that converts 7
fuel and heating oil. commercial thinnings and tree cellulosic biomass to fuel.
residue, switchgrass,
miscanthus, energy cane,
Arundo donax, Pennisetum
purpureum, and separated yard
waste; biogenic components of
separated MSW; cellulosic
components of separated food
waste; and cellulosic
components of annual cover
crops.
[[Page 173]]
M Renewable Gasoline and Crop residue, slash, pre- Catalytic Pyrolysis and 3
Renewable Gasoline commercial thinnings, tree Upgrading, Gasification and
Blendstock; Co-Processed residue, and separated yard Upgrading, Thermo-Catalytic
Cellulosic Diesel, Jet waste; biogenic components of Hydrodeoxygenation and
Fuel, and Heating Oil. separated MSW; cellulosic Upgrading, Direct Biological
components of separated food Conversion, Biological
waste; and cellulosic Conversion and Upgrading
components of annual cover utilizing natural gas,
crops. biogas, and/or biomass as the
only process energy sources
providing that process used
converts cellulosic biomass
to fuel; any process
utilizing biogas and/or
biomass as the only process
energy sources which converts
cellulosic biomass to fuel.
N Naphtha................... Switchgrass, miscanthus, energy Gasification and upgrading 3
cane, Arundo donax, and processes that converts
Pennisetum purpureum. cellulosic biomass to fuel.
O Butanol................... Corn starch.................... Fermentation; dry mill using 6
natural gas, biomass, or
biogas for process energy.
P Ethanol, renewable diesel, The non-cellulosic portions of Any........................... 5
jet fuel, heating oil, separated food waste and non-
and naphtha. cellulosic components of
annual cover crops.
Q Renewable Compressed Biogas from landfills, Any........................... 3
Natural Gas, Renewable municipal wastewater treatment
Liquefied Natural Gas, facility digesters,
Renewable Electricity. agricultural digesters, and
separated MSW digesters; and
biogas from the cellulosic
components of biomass
processed in other waste
digesters.
R Ethanol................... Grain Sorghum.................. Dry mill process using biogas 6
from landfills, waste
treatment plants, and/or
waste digesters, and/or
natural gas, for process
energy.
S Ethanol................... Grain Sorghum.................. Dry mill process, using only 5
biogas from landfills, waste
treatment plants, and/or
waste digesters for process
energy and for on-site
production of all electricity
used at the site other than
up to 0.15 kWh of electricity
from the grid per gallon of
ethanol produced, calculated
on a per batch basis.
T Renewable Compressed Biogas from waste digesters.... Any........................... 5
Natural Gas, Renewable
Liquefied Natural Gas,
and Renewable Electricity.
----------------------------------------------------------------------------------------------------------------
Table 2 to Sec. 80.1426--Advanced Technologies
------------------------------------------------------------------------
-------------------------------------------------------------------------
Corn oil fractionation that is applied to at least 90% of the corn used
to produce ethanol on a calendar year basis.
Corn oil extraction that is applied to the whole stillage and/or
derivatives of whole stillage and results in recovery of corn oil at an
annual average rate equal to or greater than 1.33 pounds oil per bushel
of corn processed into ethanol.
Membrane separation in which at least 90% of ethanol dehydration is
carried out using a hydrophilic membrane on a calendar year basis.
Raw starch hydrolysis that is used for at least 90% of starch hydrolysis
used to produce ethanol instead of hydrolysis using a traditional high
heat cooking process, calculated on a calendar year basis.
[[Page 174]]
Combined heat and power such that, on a calendar year basis, at least
90% of the thermal energy associated with ethanol production (including
thermal energy produced at the facility and that which is derived from
an off-site waste heat supplier), exclusive of any thermal energy used
for the drying of distillers grains and solubles, is used to produce
electricity prior to being used to meet the process heat requirements
of the facility.
------------------------------------------------------------------------
[75 FR 14863, Mar. 26, 2010]
Editorial Note: For Federal Register citations affecting Sec.
80.1426, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.govinfo.gov.
Sec. 80.1427 How are RINs used to demonstrate compliance?
(a) Obligated party renewable volume obligations. (1) Except as
specified in paragraph (b) of this section or Sec. 80.1456, each party
that is an obligated party and is obligated to meet the Renewable Volume
Obligations under Sec. 80.1407 must demonstrate pursuant to Sec.
80.1451(a)(1) that it has retired for compliance purposes a sufficient
number of RINs to satisfy the following equations:
(i) Cellulosic biofuel.
([sum]RINNUM)CB,i + ([sum]RINNUM)CB,i-1 =
RVOCB,i
Where:
([sum]RINNUM)CB,i = Sum of all owned gallon-RINs that are
valid for use in complying with the cellulosic biofuel RVO,
were generated in year i, and are being applied towards the
RVOCB,i, in gallons.
([sum]RINNUM)CB,i-1 = Sum of all owned gallon-RINs that are
valid for use in complying with the cellulosic biofuel RVO,
were generated in year i-1, and are being applied towards the
RVOCB,i, in gallons.
RVOCB,i = The Renewable Volume Obligation for cellulosic
biofuel for the obligated party for calendar year i, in
gallons, pursuant to Sec. 80.1407.
(ii) Biomass-based diesel. Except as provided in paragraph (a)(7) of
this section,
([sum]RINNUM)BBD,i + ([sum]RINNUM)BBD,i-1 =
RVOBBD,i
Where:
([sum]RINNUM)BBD,i = Sum of all owned gallon-RINs that are
valid for use in complying with the biomass-based diesel RVO,
were generated in year i, and are being applied towards the
RVOBBD,i, in gallons.
([sum]RINNUM)BBD,i-1 = Sum of all owned gallon-RINs that are
valid for use in complying with the biomass-based diesel RVO,
were generated in year i-1, and are being applied towards the
RVOBBD,i, in gallons.
RVOBBD,i = The Renewable Volume Obligation for biomass-based
diesel for the obligated party for calendar year i after 2010,
in gallons, pursuant to Sec. 80.1407.
(iii) Advanced biofuel.
([sum]RINNUM)AB,i + ([sum]RINNUM)AB,i-1 =
RVOAB,i
Where:
([sum]RINNUM)AB,i = Sum of all owned gallon-RINs that are
valid for use in complying with the advanced biofuel RVO, were
generated in year i, and are being applied towards the
RVOAB,i, in gallons.
([sum]RINNUM)AB,i-1 = Sum of all owned gallon-RINs that are
valid for use in complying with the advanced biofuel RVO, were
generated in year i-1, and are being applied towards the
RVOAB,i, in gallons.
RVOAB,i = The Renewable Volume Obligation for advanced
biofuel for the obligated party for calendar year i, in
gallons, pursuant to Sec. 80.1407.
(iv) Renewable fuel.
([sum]RINNUM)RF,i + ([sum]RINNUM)RF,i-1 =
RVORF,i
Where:
([sum]RINNUM)RF,i = Sum of all owned gallon-RINs that are
valid for use in complying with the renewable fuel RVO, were
generated in year i, and are being applied towards the
RVORF,i, in gallons.
([sum]RINNUM)RF,i-1 = Sum of all owned gallon-RINs that are
valid for use in complying with the renewable fuel RVO, were
generated in year i-1, and are being applied towards the
RVORF,i, in gallons.
RVORF,i = The Renewable Volume Obligation for renewable fuel
for the obligated party for calendar year i, in gallons,
pursuant to Sec. 80.1407.
(2) RINs that are valid for use in complying with each Renewable
Volume Obligation are determined by their D codes.
(i) RINs with a D code of 3 or 7 are valid for compliance with the
cellulosic biofuel RVO.
(ii) RINs with a D code of 4 or 7 are valid for compliance with the
biomass-based diesel RVO.
[[Page 175]]
(iii) RINs with a D code of 3, 4, 5, or 7 are valid for compliance
with the advanced biofuel RVO.
(iv) RINs with a D code of 3, 4, 5, 6, or 7 are valid for compliance
with the renewable fuel RVO.
(3)(i) Except as provided in paragraph (a)(3)(ii) of this section, a
party may use the same RIN to demonstrate compliance with more than one
RVO so long as it is valid for compliance with all RVOs to which it is
applied.
(ii) A cellulosic diesel RIN with a D code of 7 cannot be used to
demonstrate compliance with both a cellulosic biofuel RVO and a biomass-
based diesel RVO.
(4) [Reserved]
(5) The value of ([Sigma]RINNUM)i-1 may not exceed values
determined by the following inequalities except as provided in paragraph
(a)(7)(iii) of this section and Sec. 80.1442(d)
([Sigma]RINNUM)CB,i-1 <=0.20 * RVOCB,i
([Sigma]RINNUM)BBD,i-1 <=0.20 * RVOBBD,i
([Sigma]RINNUM)AB,i-1 <=0.20 * RVOAB,i
([Sigma]RINNUM)RF,i-1 <=0.20 * RVORF,i
(6) Except as provided in paragraph (a)(7) of this section:
(i) RINs may only be used to demonstrate compliance with the RVOs
for the calendar year in which they were generated or the following
calendar year.
(ii) RINs used to demonstrate compliance in one year cannot be used
to demonstrate compliance in any other year.
(7) Biomass-based diesel in 2010.
(i) Prior to determining compliance with the 2010 biomass-based
diesel RVO, obligated parties may reduce the value of
RVOBBD,2010 by an amount equal to the sum of all 2008 and
2009 RINs that they used for compliance purposes for calendar year 2009
which have a D code of 2 and an RR code of 15, 16, or 17.
(ii) For calendar year 2010 only, the following equation shall be
used to determine compliance with the biomass-based diesel RVO instead
of the equation in paragraph (a)(1)(ii) of this section
([Sigma]RINNUM)BBD,2010 + ([Sigma]RINNUM)BBD,2009
+ ([Sigma]RINNUM)BBD,2008 = RVOBBD,2010
Where
([Sigma]RINNUM)BBD,2010 = Sum of all owned gallon-RINs that
are valid for use in complying with the biomass-based diesel
RVO, were generated in year 2010, and are being applied
towards the RVOBBD,2010, in gallons.
([Sigma]RINNUM)BBD,2009 = Sum of all owned gallon-RINs that
are valid for use in complying with the biomass-based diesel
RVO, were generated in year 2009, have not previously been
used for compliance purposes, and are being applied towards
the RVOBBD,2010, in gallons.
([Sigma]RINNUM)BBD,2008 = Sum of all owned gallon-RINs that
are valid for use in complying with the biomass-based diesel
RVO, were generated in year 2008, have not previously been
used for compliance purposes, and are being applied towards
the RVOBBD,2010, in gallons.
RVOBBD,2010 = The Renewable Volume Obligation for biomass-
based diesel for the obligated party for calendar year 2010,
in gallons, pursuant to Sec. 80.1407 or Sec. 80.1430, as
adjusted by paragraph (a)(7)(i) of this section.
(iii) The values of ([Sigma]RINNUM)2008 and
([Sigma]RINNUM)2009 may not exceed values determined by both
of the following inequalities
([Sigma]RINNUM)BBD,2008 <=0.087 * RVOBBD,2010
([Sigma]RINNUM)BBD,2008 + ([Sigma]RINNUM)BBD,2009
<=0.20 * RVOBBD,2010
(8) A party may only use a RIN for purposes of meeting the
requirements of paragraph (a)(1) or (a)(7) of this section if that RIN
is a separated RIN with a K code of 2 obtained in accordance with
Sec. Sec. 80.1428 and 80.1429.
(9) The number of gallon-RINs associated with a given batch-RIN that
can be used for compliance with the RVOs shall be calculated from the
following formula:
RINNUM = EEEEEEEE - SSSSSSSS + 1
Where:
RINNUM = Number of gallon-RINs associated with a batch-RIN, where each
gallon-RIN represents one gallon of renewable fuel for
compliance purposes.
EEEEEEEE = Batch-RIN component identifying the last gallon-RIN
associated with the batch-RIN.
SSSSSSSS = Batch-RIN component identifying the first gallon-RIN
associated with the batch-RIN.
(b) Deficit carryovers. (1) An obligated party that fails to meet
the requirements of paragraph (a)(1) or (a)(7) of
[[Page 176]]
this section for calendar year i is permitted to carry a deficit into
year i + 1 under the following conditions:
(i) The party did not carry a deficit into calendar year i from
calendar year i-1 for the same RVO.
(ii) The party subsequently meets the requirements of paragraph
(a)(1) of this section for calendar year i + 1 and carries no deficit
into year i + 2 for the same RVO.
(iii) For compliance with the biomass-based diesel RVO in calendar
year 2011, the deficit which is carried over from 2010 is no larger than
57% of the party's 2010 biomass-based diesel RVO as determined prior to
any adjustment applied pursuant to paragraph (a)(7)(i) of this section.
(iv) The party uses the same compliance approach in year i + 1 as it
did in year i, as provided in Sec. 80.1406(c)(2).
(2) A deficit is calculated according to the following formula:
Di = RVOi - [([Sigma]RINNUM)i +
([Sigma]RINNUM)i-1]
Where:
Di = The deficit, in gallons, generated in calendar year i
that must be carried over to year i + 1 if allowed pursuant to
paragraph (b)(1) of this section.
RVOi = The Renewable Volume Obligation for the obligated
party or exporter of renewable fuel for calendar year i, in
gallons.
([Sigma]RINNUM)i = Sum of all acquired gallon-RINs that were
generated in year i and are being applied towards the
RVOi, in gallons.
([Sigma]RINNUM)i-1 = Sum of all acquired gallon-RINs that
were generated in year i-1 and are being applied towards the
RVOi, in gallons.
(c) Exporter Renewable Volume Obligations (ERVOs). (1) Each exporter
of renewable fuel that is obligated to meet Exporter Renewable Volume
Obligations under Sec. 80.1430 must demonstrate pursuant to Sec.
80.1451(a)(1) that is has retired for compliance purposes a sufficient
number of RINs to meet its ERVOs by the deadline specified in Sec.
80.1430(f).
(2) In fulfillment of its ERVOs, each exporter of renewable fuel is
subject to the provisions of paragraphs (a)(2), (3), (6), and (8) of
this section.
(3) No more than 20 percent of the ERVO calculated according to a
formula at Sec. 80.1430(b) may be fulfilled using RINs generated in the
year prior to the year in which the RVO was incurred.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26042, May 10, 2010; 79
FR 42114, July 18, 2014; 85 FR 7076, Feb. 6, 2020; 85 FR 78467, Dec. 4,
2020; 88 FR 44584, July 12, 2023]
Sec. 80.1428 General requirements for RIN distribution.
(a) RINs assigned to volumes of renewable fuel or RNG. (1) Except as
provided in Sec. Sec. 80.1429 and 80.125(d), no person can separate a
RIN that has been assigned to a volume of renewable fuel or RNG pursuant
to Sec. 80.1426(e).
(2) An assigned RIN cannot be transferred to another person without
simultaneously transferring a volume of renewable fuel or RNG to that
same person.
(3) Assigned gallon-RINs with a K code of 1 can be transferred to
another person based on the following:
(i) Except for RNG, no more than 2.5 assigned gallon-RINs with a K
code of 1 can be transferred to another person with every gallon of
renewable fuel transferred to that same person.
(ii) For RNG, the transferor of assigned RINs for RNG must transfer
RINs under Sec. 80.125(c).
(4)(i) Except for RNG, on each of the dates listed in paragraph
(a)(4)(ii) of this section in any calendar year, the following equation
must be satisfied for assigned RINs and volumes of renewable fuel owned
by a person:
RINd <= Vd * 2.5
Where:
RINd = Total number of assigned gallon-RINs with a K code of
1 that are owned on date d.
Vd = Standardized total volume of renewable fuel owned on
date d, in gallons, per Sec. 80.1426(f)(8).
(ii) The applicable dates are March 31, June 30, September 30, and
December 31.
(5) Any transfer of ownership of assigned RINs must be documented on
product transfer documents generated pursuant to Sec. 80.1453.
(i) The RIN must be recorded on the product transfer document used
to transfer ownership of the volume of renewable fuel or RNG to another
person; or
[[Page 177]]
(ii) The RIN must be recorded on a separate product transfer
document transferred to the same person on the same day as the product
transfer document used to transfer ownership of the volume of renewable
fuel or RNG.
(b) RINs separated from volumes of renewable fuel or RNG.
(1) Unless otherwise specified, any person that has registered
pursuant to Sec. 80.1450 can own a separated RIN.
(2) Separated RINs can be transferred any number of times.
(c) RIN expiration. Except as provided in Sec. 80.1427(a)(7), a RIN
is valid for compliance during the calendar year in which it was
generated, or the following calendar year. Any RIN that is not used for
compliance purposes for the calendar year in which it was generated, or
for the following calendar year, will be considered an expired RIN.
Pursuant to Sec. 80.1431(a), an expired RIN will be considered an
invalid RIN and cannot be used for compliance purposes.
(d) Any batch-RIN can be divided into multiple batch-RINs, each
representing a smaller number of gallon-RINs, if all of the following
conditions are met:
(1) All RIN components other than SSSSSSSS and EEEEEEEE are
identical for the original parent and newly formed daughter RINs.
(2) The sum of the gallon-RINs associated with the multiple daughter
batch-RINs is equal to the gallon-RINs associated with the parent batch-
RIN.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26042, May 10, 2010; 87
FR 39664, July 1, 2022; 88 FR 44584, July 12, 2023]
Sec. 80.1429 Requirements for separating RINs from volumes of renewable
fuel or RNG.
(a)(1) Separation of a RIN from a volume of renewable fuel or RNG
means termination of the assignment of the RIN to a volume of renewable
fuel or RNG.
(2) RINs that have been separated from volumes of renewable fuel or
RNG become separated RINs subject to the provisions of Sec. 80.1428(b).
(b) A RIN that is assigned to a volume of renewable fuel or RNG can
be separated from that volume only under one of the following
conditions:
(1) Except as provided in paragraphs (b)(7) and (9) of this section
and Sec. 80.125(d)(3), an obligated party must separate any RINs that
have been assigned to a volume of renewable fuel if that party owns that
volume.
(2) Except as provided in paragraph (b)(6) of this section, any
party that owns a volume of renewable fuel must separate any RINs that
have been assigned to that volume once the volume is blended with
gasoline or fossil-based diesel to produce a transportation fuel,
heating oil, or jet fuel. A party may separate up to 2.5 RINs per gallon
of blended renewable fuel.
(3) Any exporter of renewable fuel must separate any RINs that have
been assigned to the exported renewable fuel volume. An exporter of
renewable fuel may separate up to 2.5 RINs per gallon of exported
renewable fuel.
(4) Any party that produces, imports, owns, sells, or uses a volume
of neat renewable fuel, or a blend of renewable fuel and diesel fuel,
must separate any RINs that have been assigned to that volume of neat
renewable fuel or that blend if:
(i) The party designates the neat renewable fuel or blend as
transportation fuel, heating oil, or jet fuel; and
(ii) The neat renewable fuel or blend is used without further
blending, in the designated form, as transportation fuel, heating oil,
or jet fuel.
(5)(i) Any party that produces, imports, owns, sells, or uses a
volume of electricity or biogas for which RINs have been generated in
accordance with Sec. 80.1426(f) must separate any RINs that have been
assigned to that volume of renewable electricity or biogas if:
(A) The party designates the electricity or biogas as transportation
fuel; and
(B) The electricity or biogas is used as transportation fuel.
(ii)(A) Any biogas closed distribution system RIN generator that
generates RINs for a batch of renewable CNG/LNG under Sec. 80.130(b)
may only separate RINs that have been assigned to that batch after the
party demonstrates that the renewable CNG/LNG was used as transportation
fuel.
(B) Only an RNG RIN separator may only separate the RINs that have
been assigned to a volume of RNG after
[[Page 178]]
meeting all applicable requirements in Sec. 80.125(d)(2).
(6) RINs assigned to a volume of biodiesel can only be separated
from that volume pursuant to paragraph (b)(2) of this section if such
biodiesel is blended into diesel fuel at a concentration of 80 volume
percent biodiesel or less.
(i) This paragraph (b)(6) shall not apply to biodiesel owned by
obligated parties or to exported volumes of biodiesel.
(ii) This paragraph (b)(6) shall not apply to parties meeting the
requirements of paragraph (b)(4) of this section.
(7) For RINs that an obligated party generates for renewable fuel
that has not been blended into gasoline or diesel to produce a
transportation fuel, heating oil, or jet fuel, the obligated party can
only separate such RINs from volumes of renewable fuel if the number of
gallon-RINs separated in a calendar year are less than or equal to a
limit set as follows:
(i) For RINs with a D code of 3, the limit shall be equal to
RVOCB.
(ii) For RINs with a D code of 4, the limit shall be equal to
RVOBBD.
(iii) For RINs with a D code of 7, the limit shall be equal to the
larger of RVOBBD or RVOCB.
(iv) For RINs with a D code of 5, the limit shall be equal to
RVOAB-RVOCB-RVOBBD.
(v) For RINs with a D code of 6, the limit shall be equal to
RVORF-RVOAB.
(8) Small refiners and small refineries may only separate RINs that
have been assigned to volumes of renewable fuel that the party blends
into gasoline or diesel to produce transportation fuel, heating oil, or
jet fuel, or that the party used as transportation fuel, heating oil, or
jet fuel. This paragraph (b)(8) shall apply only under the following
conditions:
(i) During the calendar year in which the party has received a small
refinery exemption under Sec. 80.1441 or a small refiner exemption
under Sec. 80.1442; and
(ii) The party is not otherwise an obligated party during the period
of time that the small refinery or small refiner exemption is in effect.
(9) Except as provided in paragraphs (b)(2) through (5) and (8) of
this section, parties whose non-export renewable volume obligations are
solely related to the importation of products listed in Sec. 80.1407(c)
or (e), the addition of blendstocks into a volume of finished gasoline,
finished diesel fuel, or BOB, or that incur a renewable volume
obligation (RVO) under Sec. 80.1408, can only separate RINs from
volumes of renewable fuel if the number of gallon-RINs separated in a
calendar year is less than or equal to a limit set as follows:
(i) For RINs with a D code of 3, the limit shall be equal to
RVOCB.
(ii) For RINs with a D code of 4, the limit shall be equal to
RVOBBD.
(iii) For RINs with a D code of 7, the limit shall be equal to the
larger of RVOBBD or RVOCB.
(iv) For RINs with a D code of 5, the limit shall be equal to
RVOAB-RVOCB-RVOBBD.
(v) For RINs with a D code of 6, the limit shall be equal to
RVORF-RVOAB.
(10) Any party that produces a volume of renewable fuel or RNG may
separate any RINs that have been generated to represent that volume of
renewable fuel or RNG if that party retires the separated RINs to
replace invalid RINs according to Sec. 80.1474.
(c) The party responsible for separating a RIN from a volume of
renewable fuel or RNG shall change the K code in the RIN from a value of
1 to a value of 2 prior to transferring the RIN to any other party.
(d) Upon and after separation of a RIN from its associated volume of
renewable fuel or RNG, the separated RIN must be accompanied by a PTD
pursuant to Sec. 80.1453 when transferred to another party.
(e) Upon and after separation of a RIN from its associated volume of
renewable fuel or RNG, product transfer documents used to transfer
ownership of the volume must meet the requirements of Sec. 80.1453.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26042, May 10, 2010; 77
FR 1355, Jan. 9, 2012; 79 FR 42115, July 18, 2014; 85 FR 7076, Feb. 6,
2020; 85 FR 78467, Dec. 4, 2020; 87 FR 39664, July 1, 2022; 88 FR 44585,
July 12, 2023]
Sec. 80.1430 Requirements for exporters of renewable fuels.
(a) Any exporter of renewable fuel, whether in its neat form or
blended shall acquire sufficient RINs to comply
[[Page 179]]
with all applicable Renewable Volume Obligations under paragraphs (b)
through (e) of this section representing the exported renewable fuel. No
provision of this section applies to renewable fuel purchased directly
from the renewable fuel producer and for which the exporter of renewable
fuel can demonstrate that no RINs were generated through the
recordkeeping requirements of Sec. 80.1454(a)(6).
(b) Exporter Renewable Volume Obligations (ERVOs). An exporter of
renewable fuel shall determine its Exporter Renewable Volume Obligations
from the volumes of the renewable fuel exported.
(1) Cellulosic biofuel.
ERVOCB,k = VOLk* EVk
Where:
ERVOCB,k = The Exporter Renewable Volume Obligation for
cellulosic biofuel for discrete volume k in gallons.
k = A discrete volume of renewable fuel that the exporter of renewable
fuel knows or has reason to know is cellulosic biofuel that is
exported in a single shipment.
VOLk = The standardized volume of discrete volume k, in
gallons, calculated in accordance with Sec. 80.1426(f)(8).
EVk = The equivalence value associated with discrete volume
k.
(2) Biomass-based diesel.
ERVOBBD,k = VOLk* EVk
Where:
ERVOBBDI,k = The Exporter Renewable Volume Obligation for
biomass-based diesel for discrete volume k, in gallons.
k = A discrete volume of renewable fuel that is biodiesel or renewable
diesel and is exported in a single shipment.
VOLk = The standardized volume of discrete volume k
calculated in accordance with Sec. 80.1426(f)(8).
EVk = The equivalence value associated with discrete volume
k.
(3) Advanced biofuel.
ERVOAB,k = VOLk* EVk
Where:
ERVOAB,k = The Exporter Renewable Volume Obligation for
advanced biofuel for discrete volume k, in gallons.
k = A discrete volume of renewable fuel that is advanced biofuel
(including biomass-based diesel, renewable diesel, cellulosic
biofuel and other advanced biofuel) and is exported in a
single shipment.
VOLk = The standardized volume of discrete volume k, in
gallons, calculated in accordance with Sec. 80.1426(f)(8).
EVk = The equivalence value associated with discrete volume
k.
(4) Renewable fuel.
ERVORF,i = VOLk* EVk
Where:
ERVORF,i = The Renewable Volume Obligation for renewable fuel
for discrete volume k, in gallons.
k = A discrete volume of exported renewable fuel that is exported in a
single shipment.
VOLk = The standardized volume of discrete volume k, in
gallons, calculated in accordance with Sec. 80.1426(f)(8).
EVk = The equivalence value associated with discrete volume
k.
(c) If the exporter of renewable fuel knows or has reason to know
that a volume of exported renewable fuel is cellulosic diesel, the
exporter of renewable fuel must treat the exported volume as either
cellulosic biofuel or biomass-based diesel when determining his
Renewable Volume Obligations pursuant to paragraph (b) of this section.
(d) For the purposes of calculating the Renewable Volume
Obligations:
(1) If the equivalence value for a volume of exported renewable fuel
can be determined pursuant to Sec. 80.1415 based on its composition,
then the appropriate equivalence value shall be used in the calculation
of the exporter of renewable fuel's Renewable Volume Obligations under
paragraph (b) of this section.
(2) If the category of the exported renewable fuel is known to be
biomass-based diesel but the composition is unknown, the value of
EVk shall be 1.5.
(3) If neither the category nor composition of a volume of exported
renewable fuel can be determined, the value of EVk shall be
1.0.
(e) For renewable fuels that are in the form of a blend at the time
of export, the exporter of renewable fuel shall determine the volume of
exported renewable fuel based on one of the following:
(1) Information from the supplier of the blend of the concentration
of renewable fuel in the blend.
(2) Determination of the renewable portion of the blend using Method
B or Method C of ASTM D6866 (incorporated
[[Page 180]]
by reference, see Sec. 80.12), or an alternative test method as
approved by the EPA.
(3) Assuming the maximum concentration of the renewable fuel in the
blend as allowed by law and/or regulation.
(f) Each exporter of renewable fuel must fulfill its ERVO for each
discrete volume of exported renewable fuel within thirty days of export,
and must demonstrate compliance with its ERVOs pursuant to Sec.
80.1427(c).
(g) Each exporter of renewable fuel must fulfill any 2014 ERVOs
existing as of September 16, 2014 for which RINs have not yet been
retired by the compliance demonstration deadline for the 2013 compliance
period, and must demonstrate compliance with such ERVOs pursuant to
Sec. 80.1427(c).
(h) Each person meeting the definition of exporter of renewable fuel
for a particular export transaction is jointly and severally liable for
completion of the requirements of this section and all associated RIN
retirement demonstration, registration, reporting, and attest engagement
obligations under this subpart. However, these requirements for
exporters of renewable fuel must be met only once for any export
transaction.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26042, May 10, 2010; 79
FR 42115, July 18, 2014; 85 FR 7076, Feb. 6, 2020; 87 FR 39665, July 1,
2022; 88 FR 44585, July 12, 2023]
Sec. 80.1431 Treatment of invalid RINs.
(a) Invalid RINs. (1) An invalid RIN is a RIN that is any of the
following:
(i) A duplicate of a valid RIN.
(ii) Was based on incorrect volumes or volumes that have not been
standardized to 60 [deg]F.
(iii) Has expired, as provided in Sec. 80.1428(c).
(iv) Was based on an incorrect equivalence value.
(v) Deemed invalid under Sec. 80.1467(g).
(vi) Does not represent renewable fuel or RNG.
(vii) Was assigned an incorrect ``D'' code value under Sec.
80.1426(f) for the associated volume of fuel.
(viii) Was generated for fuel that was not used in the covered
location.
(ix) Was otherwise improperly generated.
(x) Was inappropriately separated under Sec. 80.125(d).
(2) In the event that the same RIN is transferred to two or more
parties, all such RINs are deemed invalid, unless EPA in its sole
discretion determines that some portion of these RINs is valid.
(3) If any RIN generated for a batch of renewable fuel produced
using a biointermediate is invalid, then all RINs generated for that
batch of renewable fuel are deemed invalid, unless EPA in its sole
discretion determines that some portion of those RINs are valid.
(4) If any RIN generated for a batch of renewable fuel that had RINs
apportioned through Sec. 80.1426(f)(3) is invalid, then all RINs
generated for that batch of renewable fuel are deemed invalid, unless
EPA in its sole discretion determines that some portion of those RINs
are valid.
(b) Except as provided in paragraph (c) of this section and Sec.
80.1473, the following provisions apply in the case of RINs that are
invalid:
(1) Upon determination by any party that RINs owned are invalid, the
party must keep copies and adjust its records, reports, and compliance
calculations in which the invalid RINs were used. The party must retire
the invalid RINs in the applicable RIN transaction reports under Sec.
80.1451(c)(2) for the quarter in which the RINs were determined to be
invalid.
(2) Invalid RINs cannot be used to achieve compliance with the
Renewable Volume Obligations of an obligated party or exporter of
renewable fuel, regardless of the party's good faith belief that the
RINs were valid at the time they were acquired.
(3) Any valid RINs remaining after invalid RINs are retired must
first be applied to correct the transfer of invalid RINs to another
party before applying the valid RINs to meet the party's Renewable
Volume Obligations at the end of the compliance year.
(c) Improperly generated RINs may be used for compliance provided
that all the following conditions and requirements are satisfied and the
RIN generator demonstrates that the conditions and requirements are
satisfied
[[Page 181]]
through the reporting and recordkeeping requirements set forth below,
that:
(1) The number of RINs generated for a batch exceeds the number of
RINs that should have been properly generated.
(2) The RINs were improperly generated as a result of a broken
meter, an inadvertent temperature correction error, or an inadvertent
administrative error.
(3) The renewable fuel producer or importer had in place at the time
the RINs were improperly generated a quality assurance/quality control
plan designed to ensure that process measuring equipment such as meters
and temperature probes are properly maintained and to prevent
inadvertent administrative errors.
(4) The renewable fuel producer or importer has taken any
appropriate additional steps to prevent similar violations from
occurring in the future.
(5) The improperly generated RINs have been transferred to another
party.
(6) The renewable fuel producer or importer has not improperly
generated RINs for the reasons described in paragraph (c)(2) of this
section on more than five batches during any calendar year.
(7) All of the following remedial actions have been implemented
within 30 days of the EMTS submission date of the improper RIN
generation:
(i) The renewable fuel producer or importer retires an equal number
of valid RINs with the same D Code and RIN year as the properly
generated RINs, using an EMTS retire code of 110.
(ii) The renewable fuel producer or importer reports all the
following information to EPA via EMTS, which EPA may make publicly
available:
(A) Company name.
(B) Company ID.
(C) Facility name.
(D) Facility ID.
(E) The date the renewable fuel was produced.
(F) The date the RINs were originally generated.
(G) The number of RINs generated.
(H) The number of RINs improperly generated.
(I) RIN year.
(J) D codes of generated RINs.
(K) Batch numbers.
(L) EMTS Transaction ID of the original generation.
(M) An explanation of how the violation occurred, and why the
improperly generated RINs meet the criteria in paragraph (c)(2) of this
section.
(N) Steps taken to prevent similar violations from occurring in the
future.
(O) Information under paragraphs (c)(3), (c)(4), and (c)(5) of this
section.
(P) Any additional information that EPA may require.
(8) The renewable fuel producer or importer maintains all records
relating to the improper RIN generation and the associated remedial
actions taken, including but not limited to any of the following:
(i) All information regarding the generation of invalid RINs,
including information that is sufficient to demonstrate that the
improperly generated RINs meet the criteria in paragraph (c)(2) of this
section.
(ii) Documents demonstrating that the renewable fuel producer or
importer has implemented the quality control/quality assurance plan
required in paragraph (c)(3) of this section, and has taken all
appropriate additional steps to prevent similar violations from
occurring in the future.
(iii) All correspondence with EPA.
(iv) All EMTS transactions (Generation, Buy, Sell and Retire).
(v) All Product Transfer Documents (PTDs).
(d) If EPA determines that a renewable fuel producer improperly
generated RINs but did not meet the requirements set forth in paragraph
(c) of this section, then the requirements of paragraph (b) of this
section apply from the moment that the invalid RINs were generated in
EMTS. Once the RIN generator has identified improperly generated RINs to
EPA, then EPA may remove these improperly generated RINs from EMTS.
[75 FR 14863, Mar. 26, 2010, as amended at 77 FR 1355, Jan. 9, 2012; 79
FR 42115, July 18, 2014; 85 FR 7076, Feb. 6, 2020; 87 FR 39665, July 1,
2022; 88 FR 44585, July 12, 2023]
Sec. 80.1432 Reported spillage or disposal of renewable fuel.
(a) A reported spillage or disposal under this subpart means a
spillage or
[[Page 182]]
disposal of renewable fuel associated with a requirement by a federal,
state, or local authority to report the spillage or disposal.
(b) Except as provided in paragraph (c) of this section, in the
event of a reported spillage or disposal of any volume of renewable
fuel, the owner of the renewable fuel must retire a number of RINs
corresponding to the volume of spilled or disposed of renewable fuel
multiplied by its equivalence value.
(1) If the equivalence value for the spilled or disposed of volume
may be determined pursuant to Sec. 80.1415 based on its composition,
then the appropriate equivalence value shall be used.
(2) If the equivalence value for a spilled or disposed of volume of
renewable fuel cannot be determined, the equivalence value shall be 1.0.
(c) If the owner of a volume of renewable fuel that is spilled or
disposed of and reported establishes that no RINs were generated to
represent the volume, then no RINs shall be retired.
(d) A RIN that is retired under paragraph (b) of this section:
(1) Must be reported as a retired RIN in the applicable reports
under Sec. 80.1451.
(2) May not be transferred to another person or used by any
obligated party to demonstrate compliance with the party's Renewable
Volume Obligations.
Sec. 80.1433 [Reserved]
Sec. 80.1434 RIN retirement.
(a) A RIN must be retired in any of the following cases:
(1) Demonstrate annual compliance. Except as specified in paragraph
(b) of this section or Sec. 80.1456, an obligated party required to
meet the RVO under Sec. 80.1407 must retire a sufficient number of RINs
to demonstrate compliance with an applicable RVO.
(2) Exported renewable fuel. Any exporter of renewable fuel that
incurs an ERVO as described in Sec. 80.1430(a) shall retire RINs
pursuant to Sec. Sec. 80.1430(b) through (g) and 80.1427(c).
(3) Volume error correction. A RIN must be retired when it was based
on incorrect volumes or volumes that have not been standardized to 60
[deg]F as described in Sec. 80.1426(f)(8).
(4) Import volume correction. Where the port of entry volume is the
lesser of the two volumes in Sec. 80.1466(e)(1)(i), the importer shall
calculate the difference between the number of RINs originally assigned
by the foreign producer and the number of RINs calculated under Sec.
80.1426 for the volume of renewable fuel as measured at the port of
entry, and retire that amount of RINs in accordance with Sec.
80.1466(k)(4).
(5) Spillage, leakage, or disposal of renewable fuels. Except as
provided in Sec. 80.1432(c), in the event that a reported spillage,
leakage, or disposal of any volume of renewable fuel, the owner of the
renewable fuel must notify any holder or holders of the attached RINs
and retire a number of gallon-RINs corresponding to the volume of
spilled or disposed of renewable fuel multiplied by its equivalence
value in accordance with Sec. 80.1432(b).
(6) Contaminated or spoiled fuel. In the event that contamination or
spoliation of any volume of renewable fuel is reported, the owner of the
renewable fuel must notify any holder or holders of the attached RINs
and retire a number of gallon-RINs corresponding to the volume of
contaminated or spoiled renewable fuel multiplied by its equivalence
value.
(i) If the equivalence value for the contaminated or spoiled volume
may be determined pursuant to Sec. 80.1415 based on its composition,
then the appropriate equivalence value shall be used.
(ii) If the equivalence value for a contaminated or spoiled volume
of renewable fuel cannot be determined, the equivalence value shall be
1.0.
(iii) If the owner of a volume of renewable fuel that is
contaminated or spoiled and reported establishes that no RINs were
generated to represent the volume, then no gallon-RINs shall be retired.
(7) Delayed RIN generation. In the event that a party generated a
delayed RIN as described in Sec. 80.1426(g)(1) through (4), parties
must retire RINs as described in accordance with Sec. 80.1426(g)(5) and
(6).
(8) Invalid RIN. In the case that a RIN is invalid as described in
Sec. 80.1431(a), the RIN will be considered invalid and must be retired
as described in Sec. 80.1431(b).
[[Page 183]]
(9) Potentially invalid RINs. In the case that a RIN is identified
as a PIR under Sec. 80.1474(b)(1), the PIRs or replacement RINs must be
retired as described in Sec. 80.1474(b)(2) through (5).
(10) Replacement. As required by Sec. 80.1431(b) or Sec. 80.1474,
any party that must replace an invalid RIN or PIR that was used for
compliance must retire valid RINs to replace the invalid RINs originally
used for any RVO.
(11) Used to produce other renewable fuel. Any party that uses
renewable fuel or RNG to produce other renewable fuel must retire any
assigned RINs for the volume of the renewable fuel or RNG.
(12) Expired RINs for RNG. Any party owning RINs assigned to RNG as
specified in Sec. 80.125(e) must retire the assigned RIN.
(13) Other. Any other instance identified by EPA.
(b) In the case that retirement of a RIN is necessary, the following
provisions apply:
(1) Any party affected by such retirement must keep copies and
adjust its records, reports, and compliance calculations in which the
retired RIN was used.
(2) The retired RIN must be reported in the applicable reports under
Sec. 80.1451.
(3) The retired RIN must be reported in the EPA Moderated
Transaction System pursuant to Sec. 80.1452(c).
(4) Where the importer of renewable fuel is required to retire RINs
under paragraph (a)(5) of this section, the importer must report the
retired RINs in the applicable reports under Sec. Sec. 80.1451,
80.1466(k), and 80.1466(m).
[85 FR 7076, Feb. 6, 2020, as amended at 88 FR 44585, July 12, 2023]
Sec. 80.1435 How are RIN holdings and RIN holding thresholds calculated?
Beginning January 1, 2020, any party that holds RINs must comply
with the requirements of this section.
(a) RIN holdings calculation. (1) Each party must calculate daily
end-of-day separated D6 RIN holdings by aggregating its end-of-day
separated D6 RIN holdings with the end-of-day separated D6 RIN holdings
of all corporate affiliates in a corporate affiliate group and use the
end-of-day separated D6 RIN holdings as specified in paragraph (b) of
this section.
(2) Each party must calculate, as applicable, the holdings-to-market
percentage under paragraph (b)(1) of this section and the holdings-to-
obligation percentage under paragraph (b)(2) of this section quarterly
in accordance with the schedule specified in Table 1 to Sec. 80.1451.
(3) For a corporate affiliate group containing at least one
obligated party that has a holdings-to-market percentage greater than
3.00 percent for any calendar day in a compliance period, as determined
under paragraph (b)(1) of this section, each party must calculate the
corporate affiliate group's holdings-to-obligation percentage as
specified in paragraph (b)(2) of this section.
(4) Each party must individually keep copies of all calculations and
supporting information for separated D6 RIN holding threshold
calculations required under this section as specified in Sec.
80.1454(p).
(b) RIN holding thresholds calculations--(1) Primary test
calculations. For each day in a compliance period, each party that owns
RINs must calculate the holdings-to-market percentage for their
corporate affiliate group using the method specified in paragraph
(b)(1)(i) or (b)(1)(ii) of this section, as applicable.
(i) For each day beginning January 1 through March 31, calculate the
holdings-to-market percentage for a corporate affiliate group as
follows:
HTMPd = [([Sigma]D6RINd)a/
(CNV_VOLTOT,i * 1.25)] * 100
Where:
HTMPd = The holdings-to-market percentage is the percentage
of separated D6 RINs a corporate affiliate group holds on
calendar day d relative to the total expected number of
separated D6 RINs in the market in compliance period i, in
percent.
d = A given calendar day.
i = The compliance period, typically expressed as a calendar year.
a = Individual corporate affiliate in a corporate affiliate group.
([Sigma]D6RINd)a = Sum of the number of separated
D6 RINs each individual corporate affiliate a holds at the end
of calendar day d, in gallon-RINs.
CNV_VOLTOT,i = The total expected annual volume of
conventional renewable fuels for the compliance period i, in
gallons.
[[Page 184]]
Unless otherwise specified, this number is 15 billion gallons.
(ii) For each day beginning April 1 through December 31, calculate
the holdings-to-market percentage for a corporate affiliate group as
follows:
HTMPd = [([Sigma]D6RINd)a/
(CNV_VOLTOT,i)] * 100
Where:
HTMPd = The holdings-to-market percentage is the percentage
of separated D6 RINs a corporate affiliate group holds on
calendar day d relative to the total expected number of
separated D6 RINs in the market in compliance period i, in
percent.
d = A given calendar day.
i = The compliance period, typically expressed as a calendar year.
a = Individual corporate affiliate in a corporate affiliate group.
([Sigma]D6RINd)a = Sum of the number of separated
D6 RINs each individual corporate affiliate a holds at the end
of calendar day d, in gallon-RINs.
CNV_VOLTOT,i = The total expected annual volume of
conventional renewable fuels for compliance period i, in
gallons. Unless otherwise specified, this number is 15 billion
gallons.
(2) Secondary threshold calculations. For each day in a compliance
period where a corporate affiliate group is required to calculate with
the secondary threshold requirement under paragraph (a)(3) of this
section, each party must calculate the holdings-to-obligation percentage
for their corporate affiliate group using the methods at paragraph
(b)(2)(i) or (b)(2)(ii) of this section, as applicable.
(i) For each day beginning January 1 through March 31, calculate the
holdings-to-obligation percentage as follows:
HTOPd = [([Sigma]D6RINd)a/
{[([Sigma]CNV_RVOi-1)a +
([Sigma]CNV_DEFi-1)a +
([Sigma]CNV_DEFi-2)a] * 1.25{time} ] * 100
Where:
HTOPd = The holdings-to-obligation percentage is the
percentage of separated D6 RINs a corporate affiliate group
holds on calendar day d relative to their expected separated
D6 RIN holdings based on the corporate affiliate group's
conventional RVO for compliance period i-1, in percent.
d = A given calendar day.
i = The compliance period, typically expressed as a calendar year.
a = Individual corporate affiliate in a corporate affiliate group.
([Sigma]D6RINd)a = Sum of the number of separated
D6 RINs each individual corporate affiliate a holds on
calendar day d, in gallon-RINs.
([Sigma]CNV_RVOi-1)a = Sum of the conventional
RVOs for each individual corporate affiliate a for compliance
period i-1 as calculated in paragraph (b)(2)(iii) of this
section, in gallon-RINs.
([Sigma]CNV_DEFi-1)a = Sum of the conventional
deficits for each individual corporate affiliate a as
calculated in paragraph (b)(2)(iv) of this section for
compliance period i-1, in gallon-RINs.
([Sigma]CNV_DEFi-2)a = Sum of the conventional
deficits for each individual corporate affiliate a as
calculated in paragraph (b)(2)(iv) of this section for
compliance period i-2, in gallon-RINs.
(ii) For each day beginning April 1 through December 31, calculate
the holdings-to-obligation percentage as follows:
HTOPd = {([Sigma]D6RINd)a/
[([Sigma]CNV_RVOi-1)a +
([Sigma]CNV_DEFi-1)a]{time} * 100
Where:
HTOPd = The holdings-to-obligation percentage is the
percentage of separated D6 RINs a corporate affiliate group
holds on calendar day d relative to their expected separated
D6 RIN holdings based on the corporate affiliate group's
conventional RVO for compliance period i-1, in percent.
d = A given calendar day.
i = The compliance period, typically expressed as a calendar year.
a = Individual corporate affiliate in a corporate affiliate group.
([Sigma]D6RINd)a = Sum of the number of separated
D6 RINs each individual corporate affiliate a holds on
calendar day d, in RIN gallons.
([Sigma]CNV_RVOi-1)a = Sum of the conventional
RVOs for each individual corporate affiliate a for compliance
period i-1 as calculated in paragraph (b)(2)(iii) of this
section, in gallon-RINs.
([Sigma]CNV_DEFi-1)a = Sum of the conventional
deficits for each individual corporate affiliate a as
calculated in paragraph (b)(2)(iv) of this section for
compliance period i-1, in gallon-RINs.
(iii) As needed to calculate the holdings-to-obligation percentage
in paragraphs (b)(2)(i) and (b)(2)(ii) of this section, calculate the
conventional RVO for an individual corporate affiliate as follows:
CNV_RVOi = {[RFStdRF,i * (GVi +
DVi)]--[RFStdAB,i * (GVi +
DVi)]{time} + ERVORF,i
[[Page 185]]
Where:
CNV_RVOi = The conventional RVO for an individual corporate
affiliate for compliance period i without deficits, in gallon-
RINs.
i = The compliance period, typically expressed as a calendar year.
RFStdRF,i = The standard for renewable fuel for compliance
period i determined by EPA pursuant to Sec. 80.1405, in
percent.
RFStdAB,i = The standard for advanced biofuel for compliance
period i determined by EPA pursuant to Sec. 80.1405, in
percent.
GVi = The non-renewable gasoline volume, determined in
accordance with Sec. 80.1407(b), (c), and (f), which is
produced in or imported into the covered location by an
obligated party for compliance period i, in gallons.
DVi = The non-renewable diesel volume, determined in
accordance with Sec. 80.1407(b), (c), and (f), which is
produced in or imported into the covered location by an
obligated party for compliance period i, in gallons.
ERVORF,i = The sum of all renewable volume obligations from
exporting renewable fuels, as calculated under Sec. 80.1430,
by an obligated party for compliance period i, in gallon-RINs.
(iv) As needed to calculate the holdings-to-obligation percentage in
paragraphs (b)(2)(i) and (b)(2)(ii) of this section, calculate the
conventional deficit for an individual corporate affiliate as follows:
CNV_DEFi = DRF,i--DAB,i
Where:
CNV_DEFi = The conventional deficit for an individual
corporate affiliate for compliance period i, in gallon-RINs.
If a conventional deficit is less than zero, use zero for
conventional deficits in paragraphs (b)(2)(i) and (b)(2)(ii)
of this section.
i = The compliance period, typically expressed as a calendar year.
DRF,i = Deficit carryover from compliance period i for
renewable fuel, in gallon-RINs.
DAB,i = Deficit carryover from compliance period i for
advanced biofuel, in gallon-RINs.
(c) Exceeding the D6 RIN holding thresholds--(1) Primary threshold
test. A non-obligated party or corporate affiliate group that does not
contain an obligated party and that has a holdings-to-market percentage
greater than 3.00 percent for any calendar day in a compliance period,
as determined under paragraph (b)(1) of this section, has exceeded the
primary threshold.
(2) Secondary threshold test. Any party or corporate affiliate group
required to calculate a holdings-to-obligation percentage under
paragraph (a)(3) of this section and that has a holdings-to-obligation
percentage greater than 130.00 percent for any calendar day in a
compliance period, as determined under paragraph (b)(2) of this section,
has exceeded the secondary threshold.
(d) Alternative gasoline and diesel production volume allowance.
Parties that must calculate the secondary threshold under paragraph
(b)(2) of this section may use alternative gasoline and diesel
production volumes if all the following requirements are met:
(1) The party must have a reasonable basis for using the alternative
production numbers (e.g., selling or acquiring a refinery or a shutdown
of a refinery).
(2) When substituting the alternative production volume for the
conventional RVO volume, the party must use actual production numbers
for any completed quarter in the compliance period and extrapolated
production numbers for any future quarters.
(3) The party must meet the applicable recordkeeping requirements of
Sec. 80.1454.
(4) The party must retain documentation of the reasonable basis and
the calculations used and must provide these to the auditor conducting
the attest engagement under Sec. 80.1464.
(e) Exemption from aggregation requirements. (1) A party may claim
exemption from the requirement to aggregate D6 RIN holdings for any
affiliate where one or more of the following apply:
(i) There is an absence of common trading-level control and
information sharing with the affiliate.
(ii) The sharing of information regarding aggregation with the
affiliate could lead either party to violate state or Federal law, or
the law of a foreign jurisdiction.
(iii) The affiliate is exempt from the regulations regarding
commodities and securities exchanges under 17 CFR 150.4(b)(7).
(2) A party must retain detailed, explanatory documentation
supporting its exemption and must provide this documentation to the
attest auditor
[[Page 186]]
under Sec. 80.1464, and to EPA upon request. Such records include, but
are not limited to, the following:
(i) Documents that reflect that the parties do not have knowledge of
the trading decisions of the other.
(ii) Documents that demonstrate that there are developed and
independent trading systems in place.
(iii) Documents that demonstrate that the parties have and enforce
written procedures to preclude each from having knowledge of, gaining
access to, or receiving data about, trades of the other.
(iv) Documents reflective of the risk management and other systems
in place.
(v) Documents that support an exemption under 17 CFR 150.4(b)(7).
(vi) Any other documents that support the applicability of the
exemption.
[84 FR 27022, June 10, 2019, as amended at 87 FR 39665, July 1, 2022; 88
FR 44586, July 12, 2023]
Sec. Sec. 80.1436-80.1439 [Reserved]
Sec. 80.1440 What are the provisions for blenders who handle and blend
less than 250,000 gallons of renewable fuel per year or who handle
renewable fuel blended for fuels under a national security exemption?
(a)(1) Renewable fuel blenders who handle and blend less than
250,000 gallons of renewable fuel per year, and who do not have one or
more reported or unreported Renewable Volume Obligations, are permitted
to delegate their RIN-related responsibilities to the party directly
upstream of them who supplied the renewable fuel for blending.
(2) Renewable fuel blenders who handle and blend renewable fuel for
parties that have a national security exemption under paragraph (f) of
this section, or a national security exemption under 40 CFR 1090.605,
and who do not have one or more reported or unreported Renewable Volume
Obligations, are permitted to delegate their RIN-related
responsibilities to the party directly upstream of them who supplied the
renewable fuel for blending.
(b) The RIN-related responsibilities that may be delegated directly
upstream include all of the following:
(1) The RIN separation requirements of Sec. 80.1429.
(2) The reporting requirements of Sec. 80.1451.
(3) The recordkeeping requirements of Sec. 80.1454.
(4) The attest engagement requirements of Sec. 80.1464.
(c) For upstream delegation of RIN-related responsibilities, both
parties must agree on the delegation, and a quarterly written statement
signed by both parties must be included with the reporting party's
reports under Sec. 80.1451.
(1) Both parties must keep copies of the signed quarterly written
statement agreeing to the upward delegation for 5 years.
(2) Parties delegating their RIN responsibilities upward shall keep
copies of their registration forms as submitted to EPA.
(3) A renewable fuel blender who delegates its RIN-related
responsibilities under this section will remain liable for any violation
of this subpart M associated with its renewable fuel blending
activities.
(d) Renewable fuel blenders who handle and blend less than 250,000
gallons of renewable fuel per year and delegate their RIN-related
responsibilities under paragraph (b) of this section must register
pursuant to Sec. 80.1450(e), and may not own RINs.
(e) Renewable fuel blenders who handle and blend less than 250,000
gallons of renewable fuel per year and who do not opt to delegate their
RIN-related responsibilities, or own RINs, will be subject to all
requirements stated in paragraph (b) of this section, and all other
applicable requirements of this subpart M.
(f) The requirements described in paragraph (b) of this section may
be delegated directly upstream for renewable fuel (neat or blended) that
is produced, imported, sold, offered for sale, supplied, offered for
supply, stored, dispensed, or transported for use in any of the
following:
(1) Tactical military vehicles, engines, or equipment having an EPA
national security exemption from emission standards under 40 CFR
85.1708, 89.908, 92.908, 94.908, 1042.635, or 1068.225.
[[Page 187]]
(2) Tactical military vehicles, engines, or equipment that are not
subject to a national security exemption from vehicle or engine
emissions standards as described in paragraph (f)(1) of this section
but, for national security purposes (for purposes of readiness for
deployment overseas), need to be fueled on the same transportation fuel,
heating oil, or jet fuel as the vehicles, engines, or equipment for
which EPA has granted such a national security exemption.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26042, May 10, 2010; 79
FR 42162, July 18, 2014; 85 FR 7077, Feb. 6, 2020; 85 FR 78467, Dec. 4,
2020]
Sec. 80.1441 Small refinery exemption.
(a)(1) Transportation fuel produced at a refinery by a refiner is
exempt from January 1, 2010, through December 31, 2010, from the
renewable fuel standards of Sec. 80.1405, and the owner or operator of
the refinery is exempt from the requirements that apply to obligated
parties under this subpart M for fuel produced at the refinery if the
refinery meets the definition of ``small refinery'' in Sec. 80.2 for
calendar year 2006.
(2) The exemption of paragraph (a)(1) of this section shall apply
unless a refiner chooses to waive this exemption (as described in
paragraph (f) of this section), or the exemption is extended (as
described in paragraph (e) of this section).
(3) [Reserved]
(4) This exemption shall only apply to refineries that process crude
oil through refinery processing units.
(5) The small refinery exemption is effective immediately, except as
specified in paragraph (b)(3) of this section.
(b)(1) A refiner owning a small refinery must submit a verification
letter to EPA containing all of the following information:
(i) The annual average aggregate daily crude oil throughput for the
period January 1, 2006 through December 31, 2006 (as determined by
dividing the aggregate throughput for the calendar year by the number
365).
(ii) A letter signed by the president, chief operating or chief
executive officer of the company, or his/her designee, stating that the
information contained in the letter is true to the best of his/her
knowledge, and that the refinery was small as of December 31, 2006.
(iii) Name, address, phone number, facsimile number, and e-mail
address of a corporate contact person.
(2) Verification letters must be submitted by July 1, 2010 to one of
the addresses listed in paragraph (h) of this section.
(c) If EPA finds that a refiner provided false or inaccurate
information regarding a refinery's crude throughput (pursuant to
paragraph (b)(1)(i) of this section) in its small refinery verification
letter, the exemption will be void as of the effective date of these
regulations.
(d) If a refiner is complying on an aggregate basis for multiple
refineries, any such refiner may exclude from the calculation of its
Renewable Volume Obligations (under Sec. 80.1407) transportation fuel
from any refinery receiving the small refinery exemption under paragraph
(a) of this section.
(e)(1) The exemption period in paragraph (a) of this section shall
be extended by EPA for a period of not less than two additional years if
a study by the Secretary of Energy determines that compliance with the
requirements of this subpart would impose a disproportionate economic
hardship on a small refinery.
(2) A refiner may petition EPA for an extension of its small
refinery exemption, based on disproportionate economic hardship, at any
time.
(i) A petition for an extension of the small refinery exemption must
specify the factors that demonstrate a disproportionate economic
hardship and must provide a detailed discussion regarding the hardship
the refinery would face in producing transportation fuel meeting the
requirements of Sec. 80.1405 and the date the refiner anticipates that
compliance with the requirements can reasonably be achieved at the small
refinery.
(ii) EPA shall act on such a petition not later than 90 days after
the date of receipt of the petition.
(iii) In order to qualify for an extension of its small refinery
exemption, a refinery must meet the definition of ``small refinery'' in
Sec. 80.2 for the most recent full calendar year prior to seeking an
extension and must be projected
[[Page 188]]
to meet the definition of ``small refinery'' in Sec. 80.2 for the year
or years for which an exemption is sought. Failure to meet the
definition of small refinery for any calendar year for which an
exemption was granted would invalidate the exemption for that calendar
year.
(f) At any time, a refiner with a small refinery exemption under
paragraph (a) of this section may waive that exemption upon notification
to EPA.
(1) A refiner's notice to EPA that it intends to waive its small
refinery exemption must be received by November 1 to be effective in the
next compliance year.
(2) The waiver will be effective beginning on January 1 of the
following calendar year, at which point the transportation fuel produced
at that refinery will be subject to the renewable fuels standard of
Sec. 80.1405 and the owner or operator of the refinery shall be subject
to all other requirements that apply to obligated parties under this
Subpart M.
(3) The waiver notice must be sent to EPA at one of the addresses
listed in paragraph (h) of this section.
(g) A refiner that acquires a refinery from either an approved small
refiner (as specified in Sec. 80.1442(a)) or another refiner with an
approved small refinery exemption under paragraph (a) of this section
shall notify EPA in writing no later than 20 days following the
acquisition.
(h) Verification letters under paragraph (b) of this section,
petitions for small refinery hardship extensions under paragraph (e) of
this section, and small refinery exemption waiver notices under
paragraph (f) of this section shall be sent to the attention of ``RFS
Program'' to the address in Sec. 80.10(a).
[75 FR 14863, Mar. 26, 2010, as amended at 79 FR 42163, July 18, 2014;
85 FR 7077, Feb. 6, 2020; 85 FR 78467, Dec. 4, 2020; 88 FR 44586, July
12, 2023]
Sec. 80.1442 What are the provisions for small refiners under the
RFS program?
(a)(1) To qualify as a small refiner under this section, a refiner
must meet all of the following criteria:
(i) The refiner produced transportation fuel at its refineries by
processing crude oil through refinery processing units from January 1,
2006 through December 31, 2006.
(ii) The refiner employed an average of no more than 1,500 people,
based on the average number of employees for all pay periods for
calendar year 2006 for all subsidiary companies, all parent companies,
all subsidiaries of the parent companies, and all joint venture
partners.
(iii) The refiner had a corporate-average crude oil capacity less
than or equal to 155,000 barrels per calendar day (bpcd) for 2006.
(2) [Reserved]
(b)(1) The small refiner exemption in paragraph (c) of this section
is effective immediately, except as provided in paragraph (b)(5) of this
section, provided that all requirements of this section are satisfied.
(2) Refiners who qualify for the small refiner exemption under
paragraph (a) of this section must submit a verification letter (and any
other relevant information) to EPA by July 1, 2010. The small refiner
verification letter must include all of the following information for
the refiner and for all subsidiary companies, all parent companies, all
subsidiaries of the parent companies, and all joint venture partners:
(i) A listing of the name and address of each company location where
any employee worked for the period January 1, 2006 through December 31,
2006.
(ii) The average number of employees at each location based on the
number of employees for each pay period for the period January 1, 2006
through December 31, 2006.
(iii) The type of business activities carried out at each location.
(iv) For joint ventures, the total number of employees includes the
combined employee count of all corporate entities in the venture.
(v) For government-owned refiners, the total employee count includes
all government employees.
(vi) The total corporate crude oil capacity of each refinery as
reported to the Energy Information Administration (EIA) of the U.S.
Department of Energy (DOE), for the period January 1, 2006 through
December 31, 2006. The
[[Page 189]]
information submitted to EIA is presumed to be correct. In cases where a
company disagrees with this information, the company may petition EPA
with appropriate data to correct the record when the company submits its
application.
(vii) The verification letter must be signed by the president, chief
operating or chief executive officer of the company, or his/her
designee, stating that the information is true to the best of his/her
knowledge, and that the company owned the refinery as of December 31,
2006.
(viii) Name, address, phone number, facsimile number, and e-mail
address of a corporate contact person.
(3) In the case of a refiner who acquires or reactivates a refinery
that was shutdown or non-operational between January 1, 2005 and January
1, 2006, the information required in paragraph (b)(2) of this section
must be provided for the time period since the refiner acquired or
reactivated the refinery.
(c) Small refiner temporary exemption. (1) Transportation fuel
produced by a small refiner pursuant to paragraph (b)(1) of this section
is exempt from January 1, 2010, through December 31, 2010, from the
renewable fuel standards of Sec. 80.1405 and the requirements that
apply to obligated parties under this subpart if the refiner meets all
the criteria of paragraph (a)(1) of this section.
(2) The small refiner exemption shall apply to a small refiner
pursuant to paragraph (b)(1) of this section or an approved foreign
small refiner unless that refiner chooses to waive this exemption (as
described in paragraph (d) of this section).
(d)(1) A refiner may, at any time, waive the small refiner exemption
under paragraph (c) of this section upon notification to EPA.
(2) A refiner's notice to EPA that it intends to waive the small
refiner exemption must be received by November 1 of a given year in
order for the waiver to be effective for the following calendar year.
The waiver will be effective beginning on January 1 of the following
calendar year, at which point the refiner will be subject to the
renewable fuel standards of Sec. 80.1405 and the requirements that
apply to obligated parties under this subpart.
(3) The waiver must be sent to EPA at one of the addresses listed in
paragraph (i) of this section.
(e) Refiners who qualify as small refiners under this section and
subsequently fail to meet all of the qualifying criteria as set out in
paragraph (a) of this section are disqualified as small refiners of
January 1 of the next calendar year, except as provided under paragraphs
(d) and (e)(2) of this section.
(1) In the event such disqualification occurs, the refiner shall
notify EPA in writing no later than 20 days following the disqualifying
event.
(2) Disqualification under this paragraph (e) shall not apply in the
case of a merger between two approved small refiners.
(f) If EPA finds that a refiner provided false or inaccurate
information in its small refiner status verification letter under this
subpart M, the refiner will be disqualified as a small refiner as of the
effective date of this subpart.
(g) Any refiner that acquires a refinery from another refiner with
approved small refiner status under paragraph (a) of this section shall
notify EPA in writing no later than 20 days following the acquisition.
(h) Extensions of the small refiner temporary exemption. (1) A small
refiner may apply for an extension of the temporary exemption of
paragraph (c)(1) of this section based on a showing of all the
following:
(i) Circumstances exist that impose disproportionate economic
hardship on the refiner and significantly affects the refiner's ability
to comply with the RFS standards.
(ii) The refiner has made best efforts to comply with the
requirements of this subpart.
(2) A refiner must apply, and be approved, for small refiner status
under this section.
(3) A small refiner's hardship application must include all the
following information:
(i) A plan demonstrating how the refiner will comply with the
requirements of Sec. 80.1405 (and all other requirements of this
subpart applicable to obligated parties), as expeditiously as possible.
[[Page 190]]
(ii) A detailed description of the refinery configuration and
operations including, at a minimum, all the following information:
(A) The refinery's total crude capacity.
(B) Total crude capacity of any other refineries owned by the same
entity.
(C) Total volume of gasoline and diesel produced at the refinery.
(D) Detailed descriptions of efforts to comply.
(E) Bond rating of the entity that owns the refinery.
(F) Estimated investment needed to comply with the requirements of
this subpart M.
(4) A small refiner shall notify EPA in writing of any changes to
its situation between approval of the extension application and the end
of its approved extension period.
(5) EPA may impose reasonable conditions on extensions of the
temporary exemption, including reducing the length of such an extension,
if conditions or situations change between approval of the application
and the end of the approved extension period.
(i) Small refiner status verification letters, small refiner
exemption waivers, or applications for extensions of the small refiner
temporary exemption under this section must be sent to the attention of
``RFS Program'' to the address in Sec. 80.10(a).
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26042, May 10, 2010; 85
FR 7077, Feb. 6, 2020; 85 FR 78467, Dec. 4, 2020; 88 FR 44586, July 12,
2023]
Sec. 80.1443 What are the opt-in provisions for noncontiguous states
and territories?
(a) Alaska or a United States territory may petition EPA to opt-in
to the program requirements of this subpart.
(b) EPA will approve the petition if it meets the provisions of
paragraphs (c) and (d) of this section.
(c) The petition must be signed by the Governor of the state or his
authorized representative (or the equivalent official of the territory).
(d)(1) A petition submitted under this section must be received by
EPA by November 1 for the state or territory to be included in the RFS
program in the next calendar year.
(2) A petition submitted under this section should be sent to the
attention of ``RFS Program'' to the address in Sec. 80.10(a).
(e) Upon approval of the petition by EPA:
(1) EPA shall calculate the standards for the following year,
including the total gasoline and diesel fuel volume for the state or
territory in question.
(2) Beginning on January 1 of the next calendar year, all gasoline
and diesel fuel refiners and importers in the state or territory for
which a petition has been approved shall be obligated parties.
(3) Beginning on January 1 of the next calendar year, all renewable
fuel producers in the state or territory for which a petition has been
approved shall, pursuant to Sec. 80.1426(a)(2), be required to generate
RINs and comply with other requirements of this subpart M that are
applicable to producers of renewable fuel.
[75 FR 14863, Mar. 26, 2010, as amended at 85 FR 7077, Feb. 6, 2020; 88
FR 44586, July 12, 2023]
Sec. 80.1444 Alternative RIN retirement schedule for small refineries.
(a) Applicability. The provisions of this section apply to the
following compliance years:
(1) 2020.
(2) [Reserved]
(b) Eligibility. Any obligated party that has a refinery that meets
the definition of small refinery in Sec. 80.1401 for the applicable
compliance year in paragraph (a) of this section (hereinafter the
``applicable compliance year'') is eligible to use the provisions of
this section for each small refinery it operates (hereinafter the
``small refinery'').
(c) Treatment of RVOs. (1) In lieu of retiring sufficient RINs under
Sec. 80.1427(a) to demonstrate compliance with the small refinery's
RVOs for the applicable compliance year by the applicable compliance
deadline, the obligated party must meet all the requirements of this
section and all other applicable requirements of this subpart.
(2) If the obligated party does not meet all of the requirements in
this section, the obligated party is subject to the requirements of
Sec. 80.1427(a).
[[Page 191]]
(d) Individual facility compliance. (1) If the obligated party
carries a deficit into the applicable compliance year from the previous
compliance year, the obligated party must comply with its RVOs for each
refinery it operates on an individual basis (as specified in Sec.
80.1406(c)) for both the previous compliance year and the applicable
compliance year.
(2) If the obligated party does not carry a deficit into the
applicable compliance year from the previous compliance year, the
obligated party must comply with its RVOs for each refinery it operates
on an individual basis (as specified in Sec. 80.1406(c)) for the
applicable compliance year.
(e) Compliance report submission and notification. The obligated
party must do all the following by the annual compliance reporting
deadline specified in Sec. 80.1451(f)(1)(i) for the applicable
compliance year (hereinafter the ``applicable compliance deadline''):
(1) Submit an annual compliance report for the small refinery for
the applicable compliance year.
(2) Notify EPA in a letter signed by the responsible corporate
officer (RCO) or RCO delegate, as specified at 40 CFR 1090.800(d), of
its intent to use the provisions of this section for the small refinery.
(f) Alternative RIN retirement schedule. The obligated party must
retire sufficient RINs to satisfy the minimum percentages of each and
every RVO for the applicable compliance year (as determined under Sec.
80.1407(a)) according to the following RIN retirement schedule:
(1) For the 2020 compliance year:
Table 1 to Paragraph (f)(1)--2020 Compliance Year RIN Retirement
Schedule
------------------------------------------------------------------------
Minimum 2020 RVOs percentage RIN
retirement Deadline
------------------------------------------------------------------------
20................................... February 1, 2023.
40................................... May 1, 2023.
60................................... August 1, 2023.
80................................... November 1, 2023.
100.................................. February 1, 2024.
------------------------------------------------------------------------
(2) [Reserved]
(g) RIN vintages and retirements. (1) The obligated party may retire
for compliance any valid RINs at the time of retirement towards the
small refinery's RVOs for the applicable compliance year and is exempt
from the requirements in Sec. 80.1427(a)(6)(i).
(2) The obligated party must not retire for compliance any prior-
year RINs for the small refinery's RVOs after the applicable compliance
deadline.
(h) Deficit carry-forward for subsequent compliance years. The
obligated party may not carry forward any deficit under Sec. 80.1427(b)
for the small refinery for compliance years after the applicable
compliance year until it has retired sufficient RINs to satisfy each and
every RVO for the applicable compliance year in its entirety.
(i) Forms and procedures. The obligated party must submit annual
compliance reports and retire RINs under this section using forms and
procedures specified by EPA under Sec. Sec. 80.1451(j) and 80.1452(d).
[87 FR 54166, Sept. 2, 2022]
Sec. Sec. 80.1445-80.1448 [Reserved]
Sec. 80.1449 What are the Production Outlook Report requirements?
(a) By June 1 of each year (September 1 for the report due in 2010),
a registered renewable fuel producer or importer must submit and an
unregistered renewable fuel producer may submit all of the following
information for each of its facilities, as applicable, to EPA:
(1) The type, or types, of renewable fuel expected to be produced or
imported at each facility owned by the renewable fuel producer or
importer.
(2) The volume of each type of renewable fuel expected to be
produced or imported at each facility.
(3) The number of RINs expected to be generated by the renewable
fuel producer or importer for each type of renewable fuel.
(4) Information about all the following:
(i) Existing and planned production capacity.
(ii) Long-range plans for expansion of production capacity at
existing facilities or construction of new facilities.
(iii) Feedstocks, biointermediates, and production processes to be
used at each production facility.
[[Page 192]]
(iv) Changes to the facility that would raise or lower emissions of
any greenhouse gases from the facility.
(5) For expanded production capacity that is planned or underway at
each existing facility, or new production facilities that are planned or
underway, information on all the following, as available:
(i) Strategic planning.
(ii) Planning and front-end engineering.
(iii) Detailed engineering and permitting.
(iv) Procurement and construction.
(v) Commissioning and startup.
(6) Whether capital commitments have been made or are projected to
be made.
(b) The information listed in paragraph (a) of this section shall
include the reporting party's best estimates for the five following
calendar years.
(c) Production outlook reports must provide an update of the
progress in each of the areas listed in paragraph (a) of this section in
comparison to information provided in previous year production outlook
reports.
(d) Production outlook reports shall be sent to the attention of
``RFS Program (Production Output Reports)'' to the address in Sec.
80.10(a).
(e) All production outlook reports required under this section shall
be submitted on forms and following procedures prescribed by EPA.
[75 FR 14863, Mar. 26, 2010, as amended at 77 FR 1356, Jan. 9, 2012; 85
FR 7077, Feb. 6, 2020; 87 FR 39665, July 1, 2022; 88 FR 44586, July 12,
2023]
Sec. 80.1450 What are the registration requirements under the RFS
program?
(a) Obligated parties and exporters. Any obligated party or any
exporter of renewable fuel must provide EPA with the information
specified for registration under 40 CFR 1090.805, if such information
has not already been provided under the provisions of this part. An
obligated party or an exporter of renewable fuel must receive EPA-issued
identification numbers prior to engaging in any transaction involving
RINs. Registration information may be submitted to EPA at any time after
publication of this rule in the Federal Register, but must be submitted
and accepted by EPA by July 1, 2010, or 60 days prior to RIN ownership,
whichever date comes later.
(b) Producers. Any RIN-generating foreign producer, any non-RIN-
generating foreign producer, any domestic renewable fuel producer that
generates RINs, or any biointermediate producer that transfers any
biointermediate for the production of a renewable fuel for RIN
generation, must provide EPA the information specified under 40 CFR
1090.805 if such information has not already been provided under the
provisions of this part, and must receive EPA-issued company and
facility identification numbers prior to the generation of any RINs for
their fuel or for fuel made with their ethanol, or prior to the transfer
of any biointermediate to be used in the production of a renewable fuel
for which RINs may be generated. Unless otherwise specifically
indicated, all the following registration information must be submitted
to EPA at least 60 days prior to the intended generation of RINs or the
intended transfer of any biointermediate to be used in the production of
a renewable fuel for which RINs may be generated. Renewable fuel
producers may generate RINs for a renewable fuel under this part after
EPA has accepted their registration and they have met all other
applicable requirements under this part.
(1) A description of the types of renewable fuels, RNG, ethanol, or
biointermediates that the producer intends to produce at the facility
and that the facility is capable of producing without significant
modifications to the existing facility. For each type of renewable fuel,
RNG, ethanol, or biointermediate the renewable fuel producer or foreign
ethanol producer must also provide all the following:
(i)(A) A list of all the feedstocks and biointermediates the
facility intends to utilize without significant modification to the
existing facility.
(B) A description of the type(s) of renewable biomass that will be
used as feedstock material to produce the biointermediate, if
applicable.
(C) A list of the EPA-issued company and facility registration
numbers of all
[[Page 193]]
biointermediate producers and biointermediate production facilities that
will supply biointermediates for renewable fuel production.
(ii) A description of the facility's renewable fuel, RNG, ethanol,
or biointermediate production processes, including:
(A) For registrations indicating production of cellulosic biofuel (D
codes 3 or 7) from feedstocks other than biogas (including through
pathways in rows K, L, M, and N of Table 1 to Sec. 80.1426), the
producer must demonstrate the ability to convert cellulosic components
of feedstock into fuel by providing all of the following:
(1) A process diagram with all relevant unit processes labeled and a
designation of which unit process is capable of performing cellulosic
treatment, including required inputs and outputs at each step.
(2) A description of the cellulosic biomass treatment process,
including required inputs and outputs used at each step.
(3) A description of the mechanical, chemical and biochemical
mechanisms by which cellulosic materials can be converted to biofuel
products.
(B) For registrations indicating the production of any
biointermediate, the biointermediate producer must provide all of the
following:
(1) For each biointermediate production facility, the company name,
EPA company registration number, and EPA facility registration number of
the renewable fuel producer and renewable fuel production facility at
which the biointermediate produced from the biointermediate production
facility will be transferred and used.
(2) Copies of documents and corresponding calculations demonstrating
production capacity of each biointermediate produced at the
biointermediate production facility.
(3) For each type of feedstock that the biointermediate producer
intends to process the biointermediate producer must provide all the
following:
(i) A list of all the feedstocks the facility intends to utilize
without significant modification to the existing facility.
(ii) A description of the type(s) of renewable biomass that will be
used as feedstock material to produce the biointermediate.
(4) The approved pathway(s) that the biointermediate could be used
in to produce renewable fuel.
(iii) The type(s) of co-products produced with each type of
renewable fuel, ethanol, or biointermediate.
(iv) A process heat fuel supply plan that includes all of the
following:
(A) For all process heat fuel, provide all the following
information:
(1) Each type of process heat fuel used at the facility to produce
the renewable fuel, ethanol, or biointermediate.
(2) The name and address of the company supplying each process heat
fuel to the renewable fuel facility, foreign ethanol facility, or
biointermediate production facility.
(B) For biogas used for process heat, provide all the following
information:
(1) Locations from which the biogas was produced or extracted.
(2) Name of suppliers of all biogas the producer purchases for use
for process heat in the facility.
(3) An affidavit from the biogas supplier stating its intent to
supply biogas to the renewable fuel producer, foreign ethanol producer,
or biointermediate producer, and the quantity and energy content of the
biogas that it intends to provide to the renewable fuel producer or
foreign ethanol producer.
(v) The following records that support the facility's baseline
volume or, for foreign ethanol facilities, their production volume:
(A) For all facilities except those described in paragraph
(b)(1)(v)(B) of this section, copies of the most recent applicable air
permits issued by the U.S. Environmental Protection Agency, state, local
air pollution control agencies, or foreign governmental agencies and
that govern the construction and/or operation of the renewable fuel or
foreign ethanol facility.
(B) For facilities claiming the exemption described in Sec.
80.1403(c) or (d):
(1) Applicable air permits issued by EPA, state, local air pollution
control agencies, or foreign governmental agencies that govern the
construction and/or operation of the renewable fuel facility that were:
[[Page 194]]
(i) Issued or revised no later than December 19, 2007, for
facilities described in Sec. 80.1403(c); or
(ii) Issued or revised no later than December 31, 2009, for
facilities described in Sec. 80.1403(d).
(2) If the air permits specified in paragraph (b)(1)(v)(B)(1) of
this section do not specify the maximum rated annual volume output of
renewable fuel, copies of documents demonstrating the facility's actual
peak capacity.
(C) For facilities not claiming the exemption described in Sec.
80.1403(c) or (d) and that are exempt from air permit requirements or
for which the maximum rated annual volume output of renewable fuel is
not specified in their air permits, appropriate documentation
demonstrating the facility's actual peak capacity or nameplate capacity.
(D) For all facilities producing renewable electricity or other
renewable fuel from biogas, submit all relevant information in Sec.
80.1426(f)(10) or (11), including:
(1) Copies of all contracts or affidavits, as applicable, that
follow the track of the biogas/CNG/LNG or renewable electricity from its
original source, to the producer that processes it into renewable fuel,
and finally to the end user that will actually use the renewable
electricity or the renewable CNG/LNG for transportation purposes.
(2) Specific quantity, heat content, and percent efficiency of
transfer, as applicable, and any conversion factors, for the renewable
fuel derived from biogas.
(E)(1) For parties registered to generate RINs for renewable CNG/LNG
prior to July 1, 2024, the registration requirements under paragraph
(b)(1)(v)(D) under this section apply until December 31, 2024.
(2) For biogas producers, RNG producers, and biogas closed
distribution system RIN generators not registered prior to July 1, 2024,
the registration requirements under Sec. 80.135 apply.
(F) Any other records as requested by EPA.
(vi) For facilities claiming the exemption described in Sec.
80.1403(c) or (d), evidence demonstrating the date that construction
commenced (as specified in Sec. 80.1403(a)(1)) including all of the
following:
(A) Contracts with construction and other companies.
(B) Applicable air permits issued by the U.S. Environmental
Protection Agency, state, local air pollution control agencies, or
foreign governmental agencies that governed the construction and/or
operation of the renewable fuel facility during construction and when
first operated.
(vii)(A) For a renewable fuel producer, foreign ethanol producer, or
biointermediate producer using separated yard waste:
(1) The location of any establishment from which the waste stream
consisting solely of separated yard waste is collected.
(2) A plan documenting how the waste will be collected and how the
renewable fuel producer or foreign ethanol producer will conduct ongoing
verification that such waste consists only of yard waste (and incidental
other components such as paper and plastics) that is kept separate since
generation from other waste materials.
(B) For a renewable fuel producer, foreign ethanol producer, or
biointermediate producer using separated food waste:
(1) A plan documenting the type(s) of separated food waste or
biogenic waste oils/fats/greases, the type(s) of establishment from
which the waste is collected, how the waste will be collected, a
description of ongoing verification measures that demonstrate such waste
consists only of food waste (and an incidental amount of other
components such as paper and plastics) or biogenic waste oils/fats/
greases that is kept separate from other waste materials, and if
applicable, how the cellulosic and non-cellulosic portions of the waste
will be quantified.
(2) [Reserved]
(viii) For a renewable fuel producer, foreign ethanol producer, or
biointermediate producer using separated municipal solid waste:
(A) The location of the municipal waste establishment(s) from which
the separated municipal solid waste is collected or from which material
is collected that will be processed to produce separated municipal solid
waste.
[[Page 195]]
(B) A plan providing ongoing verification that there is separation
of recyclable paper, cardboard, plastics, rubber, textiles, metals, and
glass wastes to the extent reasonably practicable and which documents
the following:
(1) Extent and nature of recycling that occurred prior to receipt of
the waste material by the renewable fuel producer, foreign ethanol
producer, or biointermediate producer;
(2) Identification of available recycling technology and practices
that are appropriate for removing recycling materials from the waste
stream by the fuel producer, foreign ethanol producer, or
biointermediate producer; and
(3) Identification of the technology or practices selected for
implementation by the fuel producer, foreign ethanol producer, or
biointermediate producer including an explanation for such selection,
and reasons why other technologies or practices were not.
(C) Contracts relevant to materials recycled from municipal waste
streams as described in Sec. 80.1426(f)(5)(iii).
(D) Certification by the producer that recycling is conducted in a
manner consistent with goals and requirements of applicable State and
local laws relating to recycling and waste management.
(E) The independent third-party engineer must visit all material
recovery facilities as part of the engineering review site visit under
Sec. 80.1450(b)(2) and (d)(3), as applicable.
(ix)(A) For a producer of ethanol from grain sorghum or a foreign
ethanol producer making product from grain sorghum and seeking to have
it sold as renewable fuel after addition of ethanol denaturant, provide
a plan that has been submitted and accepted by U.S. EPA that includes
the following information:
(1) Locations from which the biogas used at the facility was
produced or extracted.
(2) Name of suppliers of all biogas used at the facility.
(3) An affidavit from each biogas supplier stating its intent to
supply biogas to the renewable fuel producer or foreign ethanol
producer, the quantity and energy content of the biogas that it intends
to provide to the renewable fuel producer or foreign ethanol producer,
and that the biogas will be derived solely from landfills, waste
treatment plants, and/or waste digesters.
(4) If the producer intends to generate advanced biofuel RINs,
estimates of the total amount of electricity used from the grid, the
total amount of ethanol produced, and a calculation of the amount of
electricity used from the grid per gallon of ethanol produced.
(5) If the producer intends to generate advanced biofuel RINs, a
description of how the facility intends to demonstrate and document that
not more than 0.15 kWh of grid electricity is used per gallon of ethanol
produced, calculated on a per batch basis, at the time of RIN
generation.
(B) [Reserved]
(x)(A) For a producer of renewable fuel made from Arundo donax or
Pennisetum purpureum per Sec. 80.1426(f)(14)(i):
(1) A Risk Mitigation Plan (Plan) that demonstrates the growth of
Arundo donax or Pennisetum purpureum will not pose a significant
likelihood of spread beyond the planting area of the feedstock used for
production of the renewable fuel. The Plan must identify and incorporate
best management practices (BMPs) into the production, management,
transport, collection, monitoring, and processing of the feedstock. To
the extent practicable, the Risk Mitigation Plan should utilize a Hazard
Analysis Critical Control Point (HACCP) approach to examine each phase
of the pathway to identify spread reduction steps. BMPs should include
the development of mitigation strategies and plans to minimize escape
and other impacts (e.g., minimize soil disturbance), incorporate
desirable traits (e.g., sterility or reduced seed production), develop
and implement dispersal mitigation protocols prior to cultivation,
develop multiple year eradication controls. Eradication controls should
follow an approach of early detection and rapid response (EDRR) to
unintended spread. EDRR efforts should demonstrate the likelihood that
invasions will be halted while still localized and identify and employ
cooperative networks, communication forums, and consultation processes
with federal,
[[Page 196]]
state, and local agencies. The Risk Mitigation Plan must provide for the
following:
(i) Monitoring and reporting data for a period prior to planting
that is sufficient to establish a baseline, through crop production, and
extending beyond crop production for a sufficient period after the field
is no longer used for feedstock production to ensure no remnants of
giant reed or napier grass survive or spread.
(ii) Monitoring must include the area encompassing the feedstock
growing areas, the transportation corridor between the growing areas and
the renewable fuel production facility, and the renewable fuel
production facility, extending to the distance of potential propagation
of the feedstock species, or further if necessary.
(iii) Monitoring must reflect the likelihood of spread specific to
the feedstock.
(iv) A closure plan providing for the destruction and removal of
feedstock from the growing area upon abandonment by the feedstock grower
or end of production.
(v) A plan providing for an independent third party who will audit
the monitoring and reporting conducted in accordance with the Plan on an
annual basis, subject to approval of a different frequency by EPA.
(2) A letter from the United States Department of Agriculture
(``USDA'') to the renewable fuel producer stating USDA's conclusions and
the bases therefore regarding whether the Arundo donax or Pennisetum
purpureum does or does not present a significant likelihood of spread
beyond the planting area of the feedstock used for production of the
renewable fuel as proposed by the producer. This letter shall also
include USDA's recommendation of whether it is appropriate to require
the use of a financial mechanism to ensure the availability of financial
resources sufficient to cover reasonable potential remediation costs
associated with the invasive spread of giant reed or napier grass beyond
the intended planting areas. In coordination with USDA, EPA shall
identify for the producer the appropriate USDA office from which the
letter should originate.
(3) Identification of all federal, state, regional, and local
requirements related to invasive species that are applicable for the
feedstock at the growing site and at all points between the growing site
and the fuel production site.
(4) A copy of all state and local growing permits held by the
feedstock grower.
(5) A communication plan for notifying EPA's Office of
Transportation and Air Quality, USDA, adjacent federal land management
agencies, and any relevant state, tribal, regional, and local
authorities as soon as possible after identification of the issue if the
feedstock is detected outside planted area.
(6) A copy of the agreement between the feedstock grower and fuel
producer establishing all rights and duties of the parties related to
the Risk Mitigation Plan and any other activities and liability
associated with the prevention of the spread of Arundo donax and/or
Pennisetum purpureum outside of the intended planting area.
(7) A copy of the agreement between the fuel producer and an
independent third party describing how the third party will audit the
monitoring and reporting conducted in accordance with the Risk
Mitigation Plan on an annual basis, subject to approval of a different
timeframe by EPA.
(8) Information on the financial resources or other financial
mechanism (such as a state-administered fund, bond, or certificate of
deposit) that would be available to finance reasonable remediation
activities associated with the potential spread of giant reed or napier
grass beyond the intended planting areas, and information on whether it
is necessary to have any further such resources or mechanism. EPA may
require a demonstration that there is an adequate financial mechanism
(such as a state-administered fund, bond, or certificate of deposit) to
ensure the availability of financial resources sufficient to cover
reasonable potential remediation costs associated with the spread of
giant reed or napier grass beyond the intended planting areas.
(9) EPA may require additional information as appropriate.
[[Page 197]]
(B) For a producer of renewable fuel made from Arundo donax or
Pennisetum purpureum per Sec. 80.1426(f)(14)(ii):
(1) Clear and compelling evidence, including information and
supporting data, demonstrating that Arundo donax or Pennisetum purpureum
does not present a significant likelihood of spread beyond the planting
area of the feedstock used for production of the renewable fuel.
Evidence must include data collected from similar environments (soils,
temperatures, precipitation, USDA Hardiness Zones) as the proposed
feedstock production project site and accepted by the scientific
community. Such a demonstration should include consideration of the
elements of a Risk Mitigation Plan set forth in paragraph (b)(1)(x)(A)
of this section, fully disclose the potential invasiveness of the
feedstock, provide a closure plan for the destruction and removal of
feedstock from the growing area upon abandonment by the feedstock grower
or end of production, and explain why a Risk Mitigation Plan is not
needed to make the required determination.
(2) A letter from the United States Department of Agriculture
(``USDA'') to the renewable fuel producer stating USDA's conclusions and
the bases therefore regarding whether the Arundo donax or Pennisetum
purpureum does or does not present a significant likelihood of spread
beyond the planting area of the feedstock used for production of the
renewable fuel as proposed by the producer or importer. In coordination
with USDA, EPA shall identify for the producer the appropriate USDA
office from which the letter should originate.
(C) EPA may suspend a producer's registration for purposes of
generating RINs for renewable fuel using Arundo donax or Pennisetum
purpureum as a feedstock if such feedstock has spread beyond the
intended planting area.
(xi) For a producer of fuel oil meeting paragraph (2) of the
definition of heating oil in Sec. 80.2:
(A) An affidavit from the producer of the fuel oil meeting paragraph
(2) of the definition of ``heating oil'' in Sec. 80.2 stating that the
fuel oil for which RINs have been generated will be sold for the
purposes of heating or cooling interior spaces of homes or buildings to
control ambient climate for human comfort, and no other purpose.
(B) Affidavits from the final end user or users of the fuel oil
stating that the fuel oil meeting paragraph (2) of the definition of
``heating oil'' in Sec. 80.2 is being used or will be used for purposes
of heating or cooling interior spaces of homes or buildings to control
ambient climate for human comfort, and no other purpose, and
acknowledging that any other use of the fuel oil would violate EPA
regulations and subject the user to civil and/or criminal penalties
under the Clean Air Act.
(xii) For a producer or importer of any renewable fuel other than
ethanol, biodiesel, renewable gasoline, renewable diesel that meets the
Grade No. 1-D or No. 2-D specification in ASTM D975 (incorporated by
reference, see Sec. 80.12), biogas, or renewable electricity, all the
following:
(A) A description of the renewable fuel and how it will be blended
to into gasoline or diesel fuel to produce a transportation fuel,
heating oil or jet fuel that meets all applicable standards.
(B) A statement regarding whether the renewable fuel producer or
importer will blend the renewable fuel into gasoline or diesel fuel or
enter into a written contract for the sale and use of a specific
quantity of the renewable fuel with a party who blends the fuel into
gasoline or distillate fuel to produce a transportation fuel, heating
oil, or jet fuel that meets all applicable standards under this part and
40 CFR part 1090.
(C) If the renewable fuel producer or importer enters into a written
contract for the sale and use of a specific quantity of the renewable
fuel with a party who blends the fuel into gasoline or distillate fuel
to produce a transportation fuel, heating oil, or jet fuel, provide all
the following:
(1) The name, location and contact information for the party that
will blend the renewable fuel.
(2) A copy of the contract that requires the party to blend the
renewable fuel into gasoline or diesel fuel to produce a transportation
fuel, heating oil or jet fuel that meets all applicable standards.
[[Page 198]]
(xiii)(A) A renewable fuel producer seeking to generate D code 3 or
D code 7 RINs, a foreign ethanol producer seeking to have its product
sold as cellulosic biofuel after it is denatured, or a biointermediate
producer seeking to have its biointermediate made into cellulosic
biofuel, who intends to produce a single type of fuel using two or more
feedstocks converted simultaneously, where at least one of the
feedstocks does not have a minimum 75% average adjusted cellulosic
content, and who uses only a thermochemical process to convert feedstock
into renewable fuel, must provide all the following:
(1) Data showing the average adjusted cellulosic content of the
feedstock(s) to be used to produce fuel or biointermediate, based on the
average of at least three representative samples. Cellulosic content
data must come from an analytical method certified by a voluntary
consensus standards body or using a method that would produce reasonably
accurate results as demonstrated through peer reviewed references
provided to the third party engineer performing the engineering review
at registration. Samples must be of representative feedstock from the
primary feedstock supplier that will provide the renewable fuel or
biointermediate producer with feedstock subsequent to registration.
(2) For renewable fuel and biointermediate producers who want to use
a new feedstock(s) after initial registration, updates to their
registration under paragraph (d) of this section indicating the average
adjusted cellulosic content of the new feedstock.
(3) For renewable fuel producers already registered as of August 18,
2014, to produce a single type of fuel that qualifies for D code 3 or D
code 7 RINs (or would do so after denaturing) using two or more
feedstocks converted simultaneously using only a thermochemical process,
the information specified in this paragraph (b)(1)(xiii)(A) shall be
provided at the next required registration update under paragraph (d) of
this section.
(B) A renewable fuel producer seeking to generate D code 3 or D code
7 RINs, a foreign ethanol producer seeking to have its product sold as
cellulosic biofuel after it is denatured, or a biointermediate producer
seeking to have its biointermediate made into cellulosic biofuel, who
intends to produce a single type of fuel using two or more feedstocks
converted simultaneously, where at least one of the feedstocks does not
have a minimum 75% adjusted cellulosic content, and who uses a process
other than a thermochemical process, excluding anerobic digestion, or a
combination of processes to convert feedstock into renewable fuel or
biointermediate, must provide all the following:
(1) The expected overall fuel or biointermediate yield, calculated
as the total volume of fuel produced per batch (e.g., cellulosic biofuel
plus all other fuel) divided by the total feedstock mass per batch on a
dry weight basis (e.g., cellulosic feedstock plus all other feedstocks).
(2) The cellulosic Converted Fraction (CF) that will be used for
generating RINs under Sec. 80.1426(f)(3)(vi).
(3) Chemical analysis data supporting the calculated cellulosic
Converted Fraction and a discussion of the possible variability that
could be expected between reporting periods per Sec.
80.1451(b)(1)(ii)(U)(1). Data used to calculate the cellulosic CF must
be representative and obtained using an analytical method certified by a
voluntary consensus standards body, or using a method that would produce
reasonably accurate results as demonstrated through peer reviewed
references provided to the third party engineer performing the
engineering review at registration.
(4) A description and calculations showing how the data were used to
determine the cellulosic Converted Fraction.
(5) For renewable fuel producers already registered as of August 18,
2014, to produce a single type of fuel that qualifies for D code 3 or D
code 7 RINs (or would do so after denaturing) using two or more
feedstocks converted simultaneously using a combination of processes or
a process other than a thermochemical process, the information specified
in this paragraph (b)(1)(xiii)(B) shall be provided at the next required
registration update under paragraph (d) of this section.
[[Page 199]]
(C) A renewable fuel producer seeking to generate D code 3 or D code
7 RINs or a biointermediate producer seeking to have its biointermediate
made into cellulosic biofuel, who intends to produce biogas using two or
more feedstocks converted simultaneously in an anaerobic digester, where
at least one of the feedstocks does not have a minimum 75% adjusted
cellulosic content, must supply the information specified in Sec.
80.135(c)(10).
(xiv) For a producer of cellulosic biofuel made from energy cane, or
a foreign renewable fuel producer making ethanol from energy cane and
seeking to have it sold after denaturing as cellulosic biofuel, provide
all of the following:
(A) Data showing that the average adjusted cellulosic content of
each cane cultivar they intend to use is at least 75%, based on the
average of at least three representative samples of each cultivar.
Cultivars must be grown under normal growing conditions and consistent
with acceptable farming practices. Samples must be of feedstock from a
feedstock supplier that the fuel producer intends to use to supply
feedstock for their production process and must represent the feedstock
supplier's range of growing conditions and locations. Cellulosic content
data must come from an analytical method certified by a voluntary
consensus standards body or using a method that would produce reasonably
accurate results as demonstrated through peer reviewed references
provided to the third party engineer performing the engineering review
at registration.
(B) Producers that want to change or add new cultivar(s) after
initial registration must update their registration and provide EPA with
data in accordance with paragraph (d) of this section demonstrating that
the average adjusted cellulosic content for any new cultivar is at least
75%. Cultivars that do not meet this requirement are considered
sugarcane for purposes of Table 1 to Sec. 80.1426.
(xv) For a producer of cellulosic biofuel made from crop residue, a
foreign ethanol producer making ethanol from crop residue and seeking to
have it sold after denaturing as cellulosic biofuel, or a
biointermediate producer producing a biointermediate for use in the
production of a cellulosic biofuel made from crop residue, provide all
the following information:
(A) A list of all feedstocks the producer intends to utilize as crop
residue.
(B) A written justification which explains why each feedstock a
producer lists according to paragraph (b)(1)(xv)(A) of this section
meets the definition of crop residue.
(C) For producers already registered as of August 18, 2014 to
produce a renewable fuel using crop residue, the information specified
in this paragraph (b)(1)(xv) shall be provided at the next required
registration update under paragraph (d) of this section.
(xvi) For FFA feedstock, the biointermediate producer must provide a
description of how the biointermediate producer will determine FFA
concentration.
(2) An independent third-party engineering review and written report
and verification of the information provided pursuant to paragraph
(b)(1) of this section and Sec. 80.135, as applicable. The report and
verification shall be based upon a site visit and review of relevant
documents and shall separately identify each item required by paragraph
(b)(1) of this section, describe how the independent third-party
evaluated the accuracy of the information provided, state whether the
independent third-party agrees with the information provided, and
identify any exceptions between the independent third-party's findings
and the information provided.
(i) The verifications required under this section must be conducted
by a professional engineer, as specified in paragraphs (b)(2)(i)(A) and
(b)(2)(i)(B) of this section, who is an independent third-party. The
verifying engineer must be:
(A) For a domestic renewable fuel production facility, a foreign
ethanol production facility, or a biointermediate production facility, a
professional engineer who is licensed by an appropriate state agency in
the United States, with professional work experience in the chemical
engineering field or related to renewable fuel production.
[[Page 200]]
(B) For a foreign renewable fuel or foreign biointermediate
production facility, an engineer who is a foreign equivalent to a
professional engineer licensed in the United States with professional
work experience in the chemical engineering field or related to
renewable fuel production.
(ii) The independent third-party engineer and its contractors and
subcontractors must meet the independence requirements specified in
Sec. 80.1471(b)(1), (2), (4), (5), and (7) through (12).
(iii) The independent third-party shall retain all records
pertaining to the verification required under this section for a period
of five years from the date of creation and shall deliver such records
to EPA upon request.
(iv) The renewable fuel producer, foreign ethanol producer, or
biointermediate producer must retain records of the review and
verification, as required in Sec. 80.1454(b)(6) or (i)(4), as
applicable.
(v) The third-party must provide to EPA documentation of his or her
qualifications as part of the engineering review, including proof of
appropriate professional license or foreign equivalent.
(vi) Owners and operators of facilities described in Sec.
80.1403(c) and (d) must submit the engineering review no later than
December 31, 2010.
(vii) Reports required under this paragraph (b)(2) must be
electronically submitted directly to EPA by an independent third-party
engineer using forms and procedures established by EPA.
(viii) The independent third-party engineer must conduct engineering
reviews as follows:
(A)(1) To verify the accuracy of the information provided in
paragraph (b)(1)(ii) of this section, the independent third-party
engineer must conduct independent calculations of the throughput rate-
limiting step in the production process, take digital photographs of all
process units depicted in the process flow diagram during the site
visit, and certify that all process unit connections are in place and
functioning based on the site visit.
(2) Digital photographs of a process unit are not required if the
third-party engineer submits documentation demonstrating why they were
unable to access certain locations due to access issues or safety
concerns. EPA may not accept a registration if EPA is unable to
determine whether the facility is capable of producing the requested
renewable fuel, biointermediate, biogas, or RNG, as applicable, due to
the lack of sufficient digital photographs of process units for the
facility.
(B) To verify the accuracy of the information in paragraph
(b)(1)(iii) of this section, the independent third-party engineer must
obtain independent documentation from parties in contracts with the
producer for any co-product sales or disposals. The independent third-
party engineer may use representative sampling as specified in 40 CFR
1090.1805 to verify co-product sales or disposals.
(C) To verify the accuracy of the information provided in paragraph
(b)(1)(iv) of this section, the independent third-party engineer must
obtain independent documentation from all process heat fuel suppliers of
the process heat fuel supplied to the facility. The independent third-
party engineer may use representative sampling as specified in 40 CFR
1090.1805 to verify fuel suppliers.
(D) To verify the accuracy of the information provided in paragraph
(b)(1)(v) of this section, the independent third-party engineer must
conduct independent calculations of the Converted Fraction that will be
used to generate RINs.
(ix) The independent third-party engineer must provide to EPA
documentation demonstrating that a site visit, as specified in paragraph
(b)(2) of this section, occurred. Such documentation must include
digital photographs with date and geographic coordinates taken during
the site visit and a description of what is depicted in the photographs.
(x) The independent third-party engineer must sign, date, and submit
to EPA with the written report the following conflict of interest
statement:
``I certify that the engineering review and written report required
and submitted under 40 CFR 80.1450(b)(2) was conducted and prepared by
me, or under my direction or supervision, in
[[Page 201]]
accordance with a system designed to assure that qualified personnel
properly gather and evaluate the information upon which the engineering
review was conducted and the written report is based. I further certify
that the engineering review was conducted and this written report was
prepared pursuant to the requirements of 40 CFR part 80 and all other
applicable auditing, competency, independence, impartiality, and
conflict of interest standards and protocols. Based on my personal
knowledge and experience, and inquiry of personnel involved, the
information submitted herein is true, accurate, and complete. I am aware
that there are significant penalties for submitting false information,
including the possibility of fines and imprisonment for knowing
violations.''
(c) Importers. Importers of renewable fuel must provide EPA the
information specified under 40 CFR 1090.805, if such information has not
already been provided under the provisions of this part and must receive
an EPA-issued company identification number prior to generating or
owning RINs. Registration information must be submitted and accepted by
EPA by July 1, 2010, or 60 days prior to an importer importing any
renewable fuel with assigned RINs or generating any RINs for renewable
fuel, whichever dates comes later.
(d) Registration updates. (1)(i)(A) Any renewable fuel producer or
any foreign ethanol producer that makes changes to their facility that
will allow them to produce renewable fuel or use a biointermediate that
is not reflected in the producer's registration information on file with
EPA must update their registration information and submit a copy of an
updated independent third-party engineering review on file with EPA at
least 60 days prior to producing the new type of renewable fuel.
(B) Any biointermediate producer who makes changes to their
biointermediate production facility that will allow them to produce a
biointermediate for use in the production of a renewable fuel that is
not reflected in the biointermediate producer's registration information
on file with EPA must update their registration information and submit a
copy of an updated independent third-party engineering review on file
with EPA at least 60 days prior to producing the new biointermediate for
use in the production of the renewable fuel.
(ii) The renewable fuel producer, foreign ethanol producer, or
biointermediate producer may also submit an addendum to the independent
third-party engineering review on file with EPA provided the addendum
meets all the requirements in paragraph (b)(2) of this section and
verifies for EPA the most up-to-date information at the producer's
existing facility.
(2)(i) Any renewable fuel producer or any foreign ethanol producer
that makes any other changes to a facility that will affect the
producer's registration information but will not affect the renewable
fuel category for which the producer is registered per paragraph (b) of
this section must update their registration information 7 days prior to
the change.
(ii)(A) Any biointermediate producer that makes any other changes to
a biointermediate production facility that will affect the
biointermediate producer's registration must update their registration
information 7 days prior to the change.
(B)(1) Any biointermediate producer that intends to change the
designated renewable fuel production facility under paragraph
(b)(1)(ii)(B)(1) of this section for one of its biointermediate
production facilities must update their registration information with
EPA at least 30 days prior to transferring the biointermediate to the
newly designated renewable fuel production facility.
(2) A biointermediate producer may only change the designated
renewable fuel production facility under paragraph (b)(1)(ii)(B)(1) of
this section for each biointermediate production facility one time per
calendar year unless EPA, in its sole discretion, allows the
biointermediate producer to change the designated renewable fuel
production facility more frequently.
(3) All renewable fuel producers, foreign ethanol producers, and
biointermediate producers must update registration information and
submit an updated independent third-party engineering review as follows:
[[Page 202]]
(i) For all renewable fuel producers and foreign ethanol producers
registered in calendar year 2010, the updated registration information
and independent third-party engineering review must be submitted to EPA
by January 31, 2013, and by January 31 of no less frequent than every
third calendar year thereafter.
(ii) For all renewable fuel producers, foreign ethanol producers,
and biointermediate producers registered in any calendar year after
2010, the updated registration information and independent third-party
engineering review must be submitted to EPA by January 31 of no less
frequent than every third calendar year after the date of the first
independent third-party engineering review site visit conducted under
paragraph (b)(2) of this section. For example, if a renewable fuel
producer arranged for a third-party engineer to conduct the first site
visit on December 15, 2023, the three-year independent third-party
engineer review must be submitted by January 31, 2027.
(iii) For all renewable fuel producers, the updated independent
third-party engineering review must include all the following:
(A) The engineering review and written report and verification
required by paragraph (b)(2) of this section.
(B) A detailed review of the renewable fuel producer's calculations
and assumptions used to determine VRIN of a representative
sample of batches of each type of renewable fuel produced since the last
registration. This representative sampling must adhere to all the
following, as applicable:
(1) The representative sample must be selected in accordance with
the sample size guidelines set forth at 40 CFR 1090.1805.
(2) For updated independent third-party engineering reviews
submitted after January 31, 2024, the representative sample must be
selected from batches of renewable fuel produced through at least the
second quarter of the calendar year prior to the applicable January 31
deadline.
(iv) For biointermediate producers, in addition to conducting the
engineering review and written report and verification required by
paragraph (b)(2) of this section, the updated independent third-party
engineering review must include a detailed review of the biointermediate
producer's calculations used to determine the renewable biomass and
cellulosic renewable biomass proportions, as required to be reported to
EPA under Sec. 80.1451(j), of a representative sample of batches of
each type of biointermediate produced since the last registration. The
representative sample must be selected in accordance with the sample
size guidelines set forth at 40 CFR 1090.1805.
(v) For updated independent third-party engineering reviews
submitted after January 31, 2024, independent third-party engineers must
conduct site visits required under this paragraph (d) no sooner than
July 1 of the calendar year prior to the applicable January 31 deadline.
(vi) For updated independent third-party engineering reviews
submitted after January 31, 2024, the site visits required under this
paragraph (d) must occur when the renewable fuel production facility is
producing renewable fuel or when the biointermediate production facility
is producing biointermediates.
(vii) If a renewable fuel producer, foreign ethanol producer, or
biointermediate producer updates their registration information and
independent third-party engineering review prior to the next applicable
January 31 deadline, and the registration information and independent
third-party engineering review meet all applicable requirements under
paragraphs (b)(2) and (d)(3)(iii) of this section, the next required
registration information and independent third-party engineering review
update is due by January 31 of every third calendar year after the date
of the updated independent third-party engineering review site visit.
(e) Any party who owns RINs, intends to own RINs, or intends to
allow another party to separate RINs as per Sec. 80.1440, but who is
not covered by paragraph (a), (b), or (c) of this section, must provide
EPA the information specified under 40 CFR 1090.805, if such information
has not already been provided under the provisions of this part and must
receive an EPA-issued company identification number prior to
[[Page 203]]
owning any RINs. Registration information must be submitted at least 30
days prior to RIN ownership.
(f) Registration for any facility claiming an exemption under Sec.
80.1403(c) or (d), must be submitted by July 1, 2013. EPA may in its
sole discretion waive this requirement if it determines that the
information submitted in any later registration can be verified by EPA
in the same manner as would have been possible with a timely submission.
(g) Independent third-party auditors. Any independent third-party
auditor described in Sec. 80.1471 must register with the EPA as an
independent third-party auditor and receive an EPA issued company
identification number prior to conducting quality assurance audits
pursuant to Sec. 80.1472. Registration information must be submitted at
least 30 days prior to conducting audits of renewable fuel production or
biointermediate production facilities. The independent third-party
auditor must provide to the EPA all the following:
(1) The information specified under 40 CFR 1090.805, if such
information has not already been provided under the provisions of this
part.
(2) Documentation of professional qualifications as follows:
(i) For a professional engineer as described in Sec.
80.1450(b)(2)(i)(A) and (b)(2)(i)(B).
(ii) For a domestic independent third-party auditor or a foreign
independent third-party auditor, a certified public accountant who is
licensed by an appropriate state agency in the United States.
(iii) For a foreign independent third-party auditor, an accountant
who is a foreign equivalent to a certified public accountant licensed in
the United States.
(3) Documentation of professional liability insurance as described
in Sec. 80.1471(c).
(4) Any quality assurance plans as described in Sec. 80.1469.
(5) List of audited producers. Name, address, and company and
facility identification numbers of all renewable fuel production or
biointermediate production facilities that the independent third-party
auditor intends to audit under Sec. 80.1472.
(6) Audited producer associations. An affidavit, or electronic
consent, from each renewable fuel producer, foreign renewable fuel
producer, or biointermediate producer stating its intent to have the
independent third-party auditor conduct a quality assurance audit of any
of the renewable fuel producer's or foreign renewable fuel producer's
facilities.
(7) Independence affidavits. An affidavit stating that an
independent third-party auditor and its contractors and subcontractors
are independent, as described in Sec. 80.1471(b), of any renewable fuel
producer, foreign renewable fuel producer, or biointermediate producer.
(8) The name and contact information for each person employed (or
under contract or subcontract) by the independent third-party auditor to
conduct audits or verify RINs, as well as the name and contact
information for any professional engineer and certified public
accountant performing the review.
(9) Registration updates. (i) Any independent third-party auditor
who makes changes to its quality assurance plan(s) that will allow it to
audit new renewable fuel production or biointermediate production
facilities that is not reflected in the independent third-party
auditor's registration information on file with EPA must update its
registration information and submit a copy of an updated QAP on file
with EPA at least 60 days prior to auditing new renewable fuel
production or biointermediate production facilities.
(ii) Any independent third-party auditor who makes any changes other
than those specified in paragraphs (g)(9)(i), (iii), and (iv) of this
section that will affect the third-party auditor's registration
information must update its registration information 7 days prior to the
change.
(iii) Independent third-party auditors must update their QAPs at
least 60 days prior to verifying RINs generated or biointermediate
produced by a renewable fuel or biointermediate production facility,
respectively, for a pathway not covered in the independent third-party
auditor's QAPs.
(iv) Independent third-party auditors must update their QAPs at
least 60
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days prior to verifying RINs generated or biointermediate produced by
any renewable fuel or biointermediate production facility not identified
in the independent third-party auditor's existing registration.
(10) Registration renewal. Registrations for independent third-party
auditors expire December 31 of each calendar year. Previously approved
registrations will renew automatically if all the following conditions
are met:
(i) The independent third-party auditor resubmits all information,
updated as necessary, described in Sec. 80.1450(g)(1) through (g)(7) no
later than October 31 before the next calendar year.
(ii) The independent third-party auditor submits an affidavit
affirming that they have only verified RINs and biointermediates using a
QAP approved under Sec. 80.1469 and notified all appropriate parties of
all potentially invalid RINs as described in Sec. 80.1471(d).
(iii) The auditor has not received a notice of deficiency from the
EPA regarding its registration renewal materials.
(11) Revocation of registration. (i) EPA may issue a notice of
intent to revoke the registration of a third-party auditor if EPA
determines that the auditor has failed to fulfill any requirement of
this subpart. The notice of intent shall include an explanation of the
reasons for the proposed revocation.
(ii) Within 60 days of receipt of the notice of intent to revoke,
the independent third-party auditor may submit written comments
concerning the notice, including but not limited to a demonstration of
compliance with the requirements which provide the basis for the
proposed revocation. Communications should be sent to the EMTS support
line ([email protected]). EPA shall review and consider any
such submission before taking final action concerning the proposed
revocation.
(iii) If the auditor fails to respond in writing within 60 days to
the notice of intent to revoke, the revocation shall become final by
operation of law and EPA shall notify the independent third-party
auditor of such revocation.
(h) Deactivation of registration. (1) EPA may deactivate the
registration of any party required to register under this section Sec.
80.1450, using the process in paragraph (h)(2) of this section, if any
of the following criteria are met:
(i) Unless the party is a biointermediate producer, the party has
reported no activity in EMTS for twenty-four consecutive months.
(ii) The party has failed to comply with the registration
requirements of this section.
(iii) The party has failed to submit any required notification or
report within 30 days of the required submission date under Sec.
80.1451.
(iv) The attest engagement required under Sec. 80.1464 has not been
received within 30 days of the required submission date.
(v) The party fails to pay a penalty or to perform any requirements
under the terms of a court order, administrative order, consent decree,
or administrative settlement between the party and EPA.
(vi) The party submits false or incomplete information.
(vii) The party denies EPA access or prevents EPA from completing
authorized activities under sections 114 or 208 of the Clean Air Act
despite presenting a warrant or court order. This includes a failure to
provide reasonable assistance.
(viii) The party fails to keep or provide the records required by
this subpart.
(ix) The party otherwise circumvents the intent of the Clean Air Act
or of this subpart.
(2) Except as provided in paragraph (h)(3) of this section, EPA will
use the following process whenever it decides to deactivate the
registration of a party:
(i) EPA will provide written notification to the responsible
corporate officer identifying the reasons or deficiencies for which EPA
intends to deactivate the party's registration. The party will have 30
calendar days from the date of the notification to correct the
deficiencies identified or explain why there is no need for corrective
action.
(ii) If the basis for EPA's notice of intent to deactivate
registration is the absence of EMTS activity under paragraph (h)(1)(i)
of this section, a stated intent to engage in activity reported
[[Page 205]]
through EMTS will be sufficient to avoid deactivation of registration.
(iii) If the party does not correct identified deficiencies under
paragraphs (h)(1)(ii) through (ix) of this section, or does not provide
an adequate explanation regarding why such correction is not necessary
within the time allotted for response, EPA may deactivate the party's
registration without further notice to the party.
(3) In instances of willfulness or those in which public health,
interest, or safety requires otherwise, EPA may deactivate the
registration of the party without any notice to the party. EPA will
provide written notification to the responsible corporate officer
identifying the reasons EPA deactivated the registration of the party.
(4) Impact of registration deactivation:
(i) A party whose registration is deactivated shall still be liable
for violation of any requirements of this subpart.
(ii) A party whose registration is deactivated will not be listed on
any public list of actively registered parties that is maintained by
EPA.
(iii) A party whose registration is deactivated will not have access
to any of the electronic reporting systems associated with the renewable
fuel standard program, including the EPA Moderated Transaction System
(EMTS).
(iv) A party whose registration is deactivated must submit any
corrections of deficiencies to EPA on forms, and following policies,
established by EPA.
(v) If a party whose registration has been deactivated wishes to re-
register, they may seek to do so by submitting a new registration
pursuant to the requirements in paragraphs (a) through (c), (e), and (g)
of this section, as applicable.
(i) Registration procedures. (1) Registration shall be on forms, and
following policies, established by EPA.
(2) English language registrations--Any document submitted to EPA
under this section must be submitted in English, or shall include an
English translation.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26043, May 10, 2010; 77
FR 1356, Jan. 9, 2012; 77 FR 74606, Dec. 17, 2012; 78 FR 41714, July 11,
2013; 78 FR 62471, Oct. 22, 2013; 79 FR 42163, July 18, 2014; 79 FR
42115, July 18, 2014; 85 FR 7077, Feb. 6, 2020; 85 FR 78467, Dec. 4,
2020; 87 FR 39665, July 1, 2022; 88 FR 44586, July 12, 2023; 88 FR
51239, Aug. 3, 2023; 88 FR 44587, July 12, 2023]
Sec. 80.1451 What are the reporting requirements under the RFS program?
(a) Obligated parties and exporters. Any obligated party or exporter
of renewable fuel must submit to EPA reports according to the schedule,
and containing all the information, that is set forth in this paragraph
(a).
(1) Annual compliance reports must include all the following
information:
(i) The obligated party's or exporter of renewable fuel's name.
(ii) The EPA company registration number.
(iii) Whether the refiner is complying on a corporate (aggregate) or
facility-by-facility basis.
(iv) The EPA facility registration number, if complying on a
facility-by-facility basis.
(v)(A) For the 2010 through 2019 compliance periods, the production
volume and import volume of all of the products listed in Sec.
80.1407(c) and (e) for the compliance period.
(B) For the 2020 compliance period, separately, the production
volume and import volume of all of the gasoline products listed in Sec.
80.1407(c), the production volume and import volume of all of the MVNRLM
diesel fuel products listed in Sec. 80.1407(e), and the combined volume
of all gasoline products and MVNRLM diesel fuel listed in Sec.
80.1407(c) and (e) for the compliance period.
(C) Beginning with the 2021 compliance period, separately, the
production volume and import volume for the compliance period of all of
the following:
(1) All of the gasoline products listed in Sec. 80.1407(c).
(2) All of the MVNRLM diesel fuel products listed in Sec.
80.1407(e).
[[Page 206]]
(3) The combined production volume of all gasoline products and
MVNRLM diesel fuel.
(4) Distillate fuel that is not transportation fuel.
(5) Distillate fuel that is certified NTDF.
(vi) The RVOs, as specified in Sec. 80.1427(a) for obligated
parties and Sec. 80.1430(b) for exporters of renewable fuel, for the
reporting year.
(vii) Any deficit RVOs carried over from the previous year.
(viii) The total current-year RINs by category of renewable fuel
(i.e., cellulosic biofuel, biomass-based diesel, advanced biofuel,
renewable fuel, and cellulosic diesel), retired for compliance.
(ix) The total prior-year RINs by renewable fuel category retired
for compliance.
(x) The total cellulosic biofuel waiver credits used to meet the
party's cellulosic biofuel RVO.
(xi) A list of all RINs generated prior to July 1, 2010 that were
retired for compliance in the reporting period.
(xii) Any deficit RVO(s) carried into the subsequent year.
(xiii) Any additional information that EPA may require.
(xiv)-(xv) [Reserved]
(xvi) The total current-year RINs by category of renewable fuel
(i.e., cellulosic biofuel, biomass-based diesel, advanced biofuel,
renewable fuel, and cellulosic diesel), retired for compliance that are
invalid as specified in Sec. 80.1431(a).
(xvii) The total prior-year RINs by renewable fuel category retired
for compliance that are invalid as specified in Sec. 80.1431(a).
(xviii) A list of all RINs that were retired for compliance in the
reporting period and are invalid as specified in Sec. 80.1431(a).
(xix) For parties that redesignate certified NTDF as MVNRLM diesel
fuel under Sec. 80.1408 at any time during the compliance period, the
volumes MVNRLMBAL, MVNRLMO,
MVNRLMINVCHG, and MVNRLMI as calculated in Sec.
80.1408(a)(2).
(2) The RIN transaction reports required under paragraph (c)(1) of
this section.
(3) The quarterly RIN activity reports required under paragraph
(c)(2) of this section.
(4) Reports required under this paragraph (a) must be signed and
certified as meeting all the applicable requirements of this subpart by
the owner or a responsible corporate officer of the obligated party or
exporter of renewable fuel.
(b) Renewable fuel producers (domestic and foreign) and importers.
Any domestic producer or importer of renewable fuel who generates RINs,
or any RIN-generating foreign producer must submit to EPA reports
according to the schedule, and containing all of the following
information:
(1)(i) For RINs generated beginning on July 1, 2010, RIN generation
reports for each facility owned by the renewable fuel producer or
importer shall be submitted according to the schedule specified in
paragraph (f)(2) of this section.
(ii) The RIN generation reports shall include all the following
information for each batch of renewable fuel produced or imported, where
``batch'' means a discrete quantity of renewable fuel produced or
imported and assigned a unique batch-RIN per Sec. 80.1426(d):
(A) The RIN generator's name.
(B) The RIN generator's EPA company registration number.
(C) The renewable fuel producer EPA facility registration number.
(D) The importer EPA facility registration number and foreign
renewable fuel producer company registration number, if applicable.
(E) The applicable reporting period.
(F) The quantity of RINs generated for each batch according to Sec.
80.1426.
(G) The production date of each batch.
(H) The fuel type of each batch.
(I) The volume of ethanol denaturant and applicable equivalence
value of each batch.
(J) The volume of each batch produced.
(K) The types and quantities of feedstocks and biointermediates
used.
(L) The process(es), feedstock(s), and biointermediate(s) used and
proportion of renewable volume attributable to each process, feedstock,
and biointermediate.
[[Page 207]]
(M) The type of co-products produced with each batch.
(N) The quantity of co-products produced in each quarter.
(O) A list of the RINs generated and an affirmation that the
feedstock(s) used for each batch meets the definition of renewable
biomass.
(P) Producers of renewable electricity and producers or importers of
biogas used for transportation as described in Sec. 80.1426(f)(10) and
(11), shall report all of the following:
(1) The total energy produced and supplied for use as a
transportation fuel, in units of energy (for example, MMBtu or MW) based
on metering of gas volume or electricity.
(2) The name and location of where the fuel is sold for use as a
transportation fuel.
(Q) Producers or importers of renewable fuel produced at facilities
that use biogas for process heat as described in Sec. 80.1426(f)(12),
shall report the total energy supplied to the renewable fuel facility,
in MMBtu based on metering of gas volume.
(R) Producers or importers of renewable fuel made from separated
municipal solid waste must report the amount of paper, cardboard,
plastics, rubber, textiles, metals, and glass separated from municipal
solid waste for recycling. Reporting shall be in units of weight (in
tons).
(S) Producers of advanced biofuel using grain sorghum shall report
all of the following:
(1) The total amount of electricity that is purchased from the grid
and used at the site, based on metering, in kWh.
(2) Total amount of ethanol produced.
(3) Calculation of the amount of grid electricity used at the site
per gallon of ethanol produced in each batch.
(4) Each batch number as specified in Sec. 80.1452(b).
(5) Reference ID for documents required by Sec. 80.1454(k)(2)(D).
(T) Producers or importers of any renewable fuel other than ethanol,
biodiesel, renewable gasoline, renewable diesel that meets the Grade No.
1-D or No. 2-D specification in ASTM D975 (incorporated by reference,
see Sec. 80.12), biogas or renewable electricity, must report, on a
quarterly basis, all the following for each volume of fuel:
(1) Total volume of renewable fuel produced or imported, total
volume of renewable fuel blended into gasoline and distillate fuel by
the producer or importer, and the percentage of renewable fuel in each
batch of finished fuel.
(2) If the producer or importer generates RINs under Sec.
80.1426(f)(17)(i)(B)(2), report the name, location, and contract
information for each party that purchased the renewable fuel.
(U) Producers generating D code 3 or 7 RINs for cellulosic biofuel
other than RNG or biogas-derived renewable fuel, and that was produced
from two or more feedstocks converted simultaneously, at least one of
which has less than 75% average adjusted cellulosic content, and using a
combination of processes or a process other than a thermochemical
process or a combination of processes, must report all the following:
(1) The cellulosic converted fraction as determined by collecting
new representative process data and performing the same chemical
analysis method accepted at registration. Producers shall calculate this
information on an annual basis or within 10 business days of generating
every 500,000 gallons of cellulosic biofuel, whichever is more frequent,
and report quarterly. Reports shall include all values used to calculate
feedstock energy according to Sec. 80.1426(f)(3)(vi). If new data shows
that the cellulosic Converted Fraction is different than previously
calculated, the formula used to generate RINs under Sec. 80.1426(f)(3)
must be updated as soon as practical but no later than 5 business days
after the producer receives the updated data. If new testing data
results in a change to the cellulosic Converted Fraction, only RINs
generated after the new testing data were received, subject to the 5-day
allowance, would be affected.
(2) If the cellulosic Converted Fraction deviates from the
previously calculated cellulosic Converted Fraction by 10% or more then
the producer must notify EPA within 5 business days of receiving the new
data and must adjust the formula used to generate RINs
[[Page 208]]
under Sec. 80.1426(f)(3) for all fuel generated as soon as practical
but no later than 5 business days after the producer receives the new
data. If new testing data results in a change to the cellulosic
Converted Fraction, only RINs generated after the new testing data were
received, subject to the 5-day allowance, would be affected.
(V) Producers of renewable fuel using crop residue as a feedstock
shall report all of the following according to the schedule specified in
paragraph (f)(2) of this section:
(1) The specific feedstock(s) utilized to produce renewable fuel
under a pathway allowing the use of crop residue as feedstock.
(2) The total quantity of each specific feedstock used to produce
renewable fuel.
(3) The total amount of qualifying renewable fuel produced under the
crop residue pathway(s) in that quarter.
(W) Any additional information EPA may require.
(2) The RIN transaction reports required under paragraph (c)(1) of
this section.
(3) The RIN activity reports required under paragraph (c)(2) of this
section.
(4) Reports required under this paragraph (b) must be signed and
certified as meeting all the applicable requirements of this subpart by
the owner or a responsible corporate officer of the renewable fuel
producer or importer.
(c) All RIN-owning parties. Any party, including any party specified
in paragraphs (a) and (b) of this section, that owns RINs during a
reporting period, must submit reports to EPA according to the schedule,
and containing all the information, that is set forth in this paragraph
(c).
(1)(i) For RIN transactions beginning on July 1, 2010, RIN
transaction reports listing each RIN transaction shall be submitted
according to the schedule in paragraph (f)(2) of this section.
(ii) As per Sec. 80.1452, RIN transaction information listing each
RIN transaction shall be submitted to the EMTS.
(iii) Each report required by paragraph (c)(1)(i) of this section
shall include all of the following information:
(A) The submitting party's name.
(B) The submitting party's EPA company registration number.
(C) The applicable reporting period.
(D) Transaction type (i.e., RIN buy, RIN sell, RIN separation, RIN
retire, reinstated 2009 or 2010 RINs).
(E) Transaction date.
(F) For a RIN purchase or sale, the trading partner's name.
(G) For a RIN purchase or sale, the trading partner's EPA company
registration number. For all other transactions, the submitting party's
EPA company registration number.
(H) RIN subject to the transaction.
(I) For a RIN purchase or sale, the per gallon RIN price and/or the
per gallon price of renewable fuel price with RINs included.
(J) The reason code for retiring RINs, separating RINs, buying RINs,
or selling RINs.
(K) Any additional information that EPA may require.
(2) RIN activity reports must be submitted to EPA according to the
schedule specified in paragraph (f)(2) of this section. Each report must
summarize RIN activities for the reporting period, separately for RINs
separated from a renewable fuel volume and RINs assigned to a renewable
fuel volume.
(i) For compliance periods ending on or before December 31, 2019,
each report must include all of the following information:
(A) The submitting party's name.
(B) The submitting party's EPA company registration number.
(C) The number of current-year RINs owned at the start of the
quarter.
(D) The number of prior-year RINs owned at the start of the quarter.
(E) The total current-year RINs purchased.
(F) The total prior-year RINs purchased.
(G) The total current-year RINs sold.
(H) The total prior-year RINs sold.
(I) The total current-year RINs retired.
(J) The total current-year RINs retired that are invalid under Sec.
80.1431(a).
(K) The total prior-year RINs retired.
(L) The total prior-year RINs retired that are invalid under Sec.
80.1431(a).
(M) The number of current-year RINs owned at the end of the quarter.
(N) The number of prior-year RINs owned at the end of the quarter.
(O) The number of RINs generated.
[[Page 209]]
(P) The volume of renewable fuel (in gallons) owned at the end of
the quarter.
(Q) The total 2009 and 2010 retired RINs reinstated.
(R) Any additional information that EPA may require.
(ii) For compliance periods starting on or after January 1, 2020,
each report must include all of the following information:
(A) The submitting party's name.
(B) The submitting party's EPA-issued company identification number.
(C) Primary registration designation or compliance level for
compliance year (e.g., ``Aggregated Refiner,'' ``Exporter,'' ``Renewable
Fuel Producer,'' ``RIN Owner Only,'' etc.).
(D) All of the following information:
(1) The number of current-year RINs owned at the start of the
quarter.
(2) The number of prior-year RINs owned at the start of the quarter.
(3) The total current-year RINs purchased.
(4) The total prior-year RINs purchased.
(5) The total current-year RINs sold.
(6) The total prior-year RINs sold.
(7) The total current-year RINs retired.
(8) The total current-year RINs retired that are invalid under Sec.
80.1431(a).
(9) The total prior-year RINs retired.
(10) The total prior-year RINs retired that are invalid under Sec.
80.1431(a).
(11) The number of current-year RINs owned at the end of the
quarter.
(12) The number of prior-year RINs owned at the end of the quarter.
(13) The number of RINs generated.
(14) The volume of renewable fuel (in gallons) owned at the end of
the quarter.
(E)(1) Indicate if the submitting party or the submitting party's
corporate affiliate group exceeded the primary threshold for any day in
the quarter under Sec. 80.1435(c)(1). If the submitting party is in an
affiliate group that does not contain an obligated party, and the
affiliate group has exceeded the primary threshold, then EPA may publish
the name and EPA-issued company identification number of the submitting
party.
(2) Indicate if the submitting party or the submitting party's
corporate affiliate group exceeded the secondary threshold for any day
in the quarter under Sec. 80.1435(c)(2). If the submitting party is an
obligated party and has exceeded the secondary threshold or is in a
corporate affiliate group containing an obligated party that has
exceeded the secondary threshold, then EPA may publish the name and EPA-
issued company identification number of the submitting party.
(F) A list of all corporate and contractual affiliates during the
reporting period. For each affiliate, include the identification
information (including the EPA company ID number, if registered) and the
affiliate type.
(G) The RVO used to calculate D6 RIN threshold, if alternative
gasoline and diesel production volumes were used under Sec. 80.1435(d).
(H) A list of contractual affiliates that had a contract with the
party that did not result in transfer of RINs to the party during the
reporting period.
(I) Any additional information that EPA may require.
(3) All reports required under this paragraph (c) must be signed and
certified as meeting all the applicable requirements of this subpart by
the RIN owner or a responsible corporate officer of the RIN owner.
(d) Except for those producers using feedstocks subject to the
aggregate compliance approach described in Sec. 80.1454(g), producers
and RIN-generating importers of renewable fuel made from feedstocks that
are planted crops and crop residue from existing foreign agricultural
land, planted trees or tree residue from actively managed tree
plantations, slash and pre-commercial thinnings from forestlands or
biomass obtained from areas at risk of wildfire must submit quarterly
reports according to the schedule in paragraph (f)(2) of this section
that include all of the following:
(1) A summary of the types and quantities of feedstocks used in that
quarter.
(2) Electronic data identifying the land by coordinates of the
points defining the boundaries from which each type of feedstock listed
per paragraph (d)(1) of this section was harvested.
[[Page 210]]
(3) If electronic data identifying a plot of land have been
submitted previously, producers and RIN-generating importers may submit
a cross-reference to that electronic data.
(e) If EPA finds that the 2007 baseline amount of agricultural land
has been exceeded in any year beginning in 2010, beginning on the first
day of July of the following calendar year any producers or importers of
renewable fuel that use planted crops and/or crop residue from existing
U.S. agricultural lands as feedstock must submit quarterly reports
according to the schedule in paragraph (f)(2) of this section that
include all of the following:
(1) A summary of the types and quantities of feedstocks used in that
quarter.
(2) Electronic data identifying the land by coordinates of the
points defining the boundaries from which each type of feedstock listed
per paragraph (d)(1) of this section was harvested.
(3) If electronic data identifying a plot of land have been
submitted previously, producers and RIN-generating importers may submit
a cross-reference to that electronic data.
(f) Report submission deadlines. The submission deadlines for annual
and quarterly reports are as follows:
(1) Annual compliance reports--(i) Obligated parties. (A) Except as
specified in paragraph (f)(1)(i)(B) of this section, for obligated
parties, annual compliance reports must be submitted by whichever of the
following dates is latest:
(1) March 31 of the subsequent calendar year.
(2) The next quarterly reporting deadline under paragraph (f)(2) of
this section after the date the subsequent compliance year's renewable
fuel standards become effective in Sec. 80.1405(a).
(3) The next quarterly reporting deadline under paragraph (f)(2) of
this section after the annual compliance reporting deadline for the
prior compliance year.
(B)(1) For obligated parties that meet the requirements for a small
refinery under Sec. 80.1441(e)(2)(iii), for the 2019 compliance year,
annual compliance reports must be submitted no later than the next
quarterly reporting deadline under paragraph (f)(2) of this section
after the date the 2021 renewable fuel standards become effective in
Sec. 80.1405(a).
(2) For the 2020 compliance year, annual compliance reports must be
submitted no later than the next quarterly reporting deadline in
paragraph (f)(2) of this section after the deadline in paragraph
(f)(1)(i)(B)(1) of this section.
(3) For the 2021 compliance year, annual compliance reports must be
submitted no later than the next quarterly reporting deadline in
paragraph (f)(2) of this section after the deadline in paragraph
(f)(1)(i)(B)(2) of this section.
(4) For the 2022 compliance year, annual compliance reports must be
submitted by whichever of the following dates is latest:
(i) The next quarterly reporting deadline under paragraph (f)(2) of
this section after the date the 2023 renewable fuel standards become
effective in Sec. 80.1405(a).
(ii) The next quarterly reporting deadline in paragraph (f)(2) of
this section after the deadline in paragraph (f)(1)(i)(B)(3) of this
section.
(ii) All other parties. For all parties other than obligated
parties, annual compliance reports must be submitted by March 31 of the
subsequent year.
(iii) Deadline publication. The annual compliance reporting deadline
will be calculated in accordance with paragraph (f)(1)(i) of this
section and published on EPA's website.
(2) Quarterly compliance reports. Quarterly reports shall be
submitted by the required deadline as shown in Table 1 of this section.
Any reports generated by EMTS must be reviewed, supplemented, and/or
corrected if not complete and accurate, and verified by the owner or
responsible corporate officer prior to submittal. Table 1 follows:
Table 1 to Sec. 80.1451--Quarterly Reporting Deadlines
----------------------------------------------------------------------------------------------------------------
Calendar quarter Time period covered Quarterly report deadline
----------------------------------------------------------------------------------------------------------------
Quarter 1............................... January 1-March 31................... June 1.
[[Page 211]]
Quarter 2............................... April 1-June 30...................... September 1.
Quarter 3............................... July 1-September 30.................. December 1.
Quarter 4............................... October 1-December 31................ March 31.
----------------------------------------------------------------------------------------------------------------
(3) Report certification. Reports required must be signed and
certified as meeting all the applicable requirements of this subpart by
the owner or a responsible corporate officer of the submitter.
(4) Monthly reporting schedule. Any party required to submit
information or reports on a monthly basis must submit such information
or reports by the end of the subsequent calendar month.
(g) Independent third-party auditors. Any independent third-party
auditor must submit quarterly reports as follows:
(1) The following information for each verified batch, as
applicable:
(i) The audited party's name.
(ii) The audited party's EPA company registration number.
(iii) The audited party's EPA facility registration number.
(iv)(A) The renewable fuel importer's EPA facility registration
number and foreign renewable fuel producer's company registration
number.
(B) The RNG importer's EPA facility registration number and foreign
RNG producer's company registration number.
(v) The applicable reporting period.
(vi) The quantity of RINs generated for each verified batch
according to Sec. Sec. 80.125, 80.130, and 80.1426.
(vii) The production date of each verified batch.
(viii) The D-code of each verified batch.
(ix) The volume of ethanol denaturant and applicable equivalence
value of each verified batch.
(x) The volume of each verified batch produced.
(xi) The volume and type of each feedstock and biointermediate used
to produce the verified batch.
(xii) Whether the feedstocks and biointermediates used to produce
each verified batch met the definition of renewable biomass.
(xiii) Whether appropriate RIN generation and verified batch volume
calculations under this part were followed for each verified batch.
(xiv) The quantity and type of co-products produced.
(xv) Invoice document identification numbers associated with each
verified batch.
(xvi) Laboratory sample identification numbers for each verified
batch associated with the generation of any certificates of analysis
used to verify fuel type and quality.
(xvii) Any additional information that EPA may require.
(2) The following aggregate verification information, as applicable:
(i) The submitting party's name.
(ii) The submitting party's EPA company registration number.
(iii) The number of current-year RINs verified at the start of the
quarter.
(iv) The number of prior-year RINs verified at the start of the
quarter.
(v) The total current-year RINs verified.
(vi) The number of current-year RINs verified at the end of the
quarter.
(vii) A list of all audited facilities, including the EPA's company
and facility registration numbers, along with the date the independent
third-party auditor conducted the on-site visit and audit.
(viii) Mass and energy balances calculated for each audited
facility.
(ix) A list of all RINs that were identified as Potentially Invalid
RINs (PIRs) pursuant to Sec. Sec. 80.185 and 80.1474, along with a
narrative description of why the RINs were not verified or were
identified as PIRs.
(x) A list of all biointermediates that were identified as
potentially improperly produced biointermediates under Sec. 80.1477(d).
(xi) A list of all biogas that was identified as potentially
inaccurate or non-qualifying under Sec. 80.185(b).
[[Page 212]]
(xii) Any additional information that EPA may require.
(3) All reports required under this paragraph (g) must be signed and
certified as meeting all the applicable requirements of this subpart by
the independent third-party auditor or a responsible corporate officer
of the independent third-party auditor.
(h) Producers or importers of renewable fuel made from Arundo donax
or Pennisetum purpureum per Sec. 80.1426(f)(14) must report all the
following:
(1) Any detected growth of Arundo donax or Pennisetum purpureum
outside the intended planting areas, both surrounding the field of
production and feedstock storage sites, along the transportation route,
and around the biofuel production facility, within 5 business days after
detection and in accordance with the Risk Mitigation Plan, if
applicable.
(2) As available, any updated information related to the Risk
Mitigation Plan, as applicable. An updated Risk Mitigation Plan must be
approved by EPA in consultation with USDA and as appropriate other
federal agencies prior to its implementation.
(3) On an annual basis, a description of and maps or electronic data
showing the average and total size and prior use of lands planted with
Arundo donax or Pennisetum purpureum, the average and total size and
prior use of lands set aside to control the invasive spread of these
crops, and a description and explanation of any change in land use from
the previous year.
(4) On an annual basis, the report from an independent third party
auditor evaluating monitoring and reporting activities conducted in
accordance with the Risk Mitigation Plan, as applicable subject to
approval of a different frequency by the EPA.
(5) Information submitted pursuant to paragraphs (h)(3) and (h)(4)
of this section must be submitted as part of the producer or importer's
fourth quarterly report, which covers the reporting period October-
December, according to the schedule in paragraph (f)(2) of this section.
(i) Parties that redesignate certified NTDF as MVNRLM diesel fuel
under Sec. 80.1408 at any time during the compliance period, but do not
incur an RVO under Sec. 80.1408(a)(2)(i), must submit a report to EPA
stating that they redesignated certified NTDF to MVNRLM diesel fuel
during the compliance period, but that their net redesignated volume was
less than or equal to zero, and they therefore did not incur an RVO for
the compliance period.
(j) Biointermediate producers. For each biointermediate production
facility, any biointermediate producer must submit quarterly reports for
biointermediate batch production to EPA containing all of the
information in this paragraph (j).
(1) Include all the following information for each batch of
biointermediate produced:
(i) The biointermediate producer's name.
(ii) The biointermediate producer's EPA company registration number.
(iii) The biointermediate producer's EPA facility registration
number.
(iv) The applicable compliance period.
(v) The production date.
(vi) The batch number.
(vii) For batches of biointermediates intended for use to produce
cellulosic biofuels, the adjusted cellulosic content of each batch and
certification that the cellulosic content of each batch was derived from
cellulose, hemicellulose, or lignin that was derived from renewable
biomass.
(viii) The volume of each batch produced.
(ix) The types and quantities of feedstocks used.
(x) The renewable fuel type(s) each batch of biointermediate was
designated to be used as a feedstock material for.
(xi) The EPA company registration number and EPA facility
registration number for each renewable fuel producer or foreign
renewable fuel producer that received each batch.
(xii) The percentage of each batch of biointermediate that met the
definition of renewable biomass and certification that this portion of
the batch of biointermediate was derived from renewable biomass.
(xiii) The process(es) and feedstock(s) used and proportion of
biointermediate volume attributable to each process and feedstock.
[[Page 213]]
(xiv) The type of co-products produced with each batch.
(xv) The quantity of co-products produced in each quarter.
(xvi) Any additional information EPA may require.
(2) Quarterly reports under this paragraph (j) must be submitted
according to the schedule in paragraph (f)(2) of this section.
(k) All reports required under this section shall be submitted on
forms and following procedures prescribed by EPA.
(l) English language reports. Any document submitted to EPA under
this section must be submitted in English, or shall include an English
translation.
[75 FR 14863, Mar. 26, 2010]
Editorial Note: For Federal Register citations affecting Sec.
80.1451, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.govinfo.gov.
Sec. 80.1452 What are the requirements related to the EPA Moderated
Transaction System (EMTS)?
(a) Each party required to submit information under this section
must establish an account with the EPA Moderated Transaction System
(EMTS) at least 60 days prior to engaging in any RIN transactions, or
July 1, 2010, whichever is later.
(b) Starting July 1, 2010, each time a domestic or foreign producer
or importer of renewable fuel assigns RINs to a batch of renewable fuel
pursuant to Sec. 80.1426(e), all the following information must be
submitted to EPA via the submitting party's EMTS account within five (5)
business days of the date of RIN assignment.
(1) The name of the renewable fuel producer or importer.
(2) The EPA company registration number of the renewable fuel
producer or foreign ethanol producer, as applicable.
(3) The importer's EPA company registration number if applicable.
(4) The EPA facility registration number of the facility at which
the renewable fuel producer or foreign ethanol producer produced the
batch, as applicable.
(5) The EPA facility registration number of the importer that
imported the batch, if applicable.
(6) The D code of RINs generated for the batch.
(7) The production process(es) used for the batch.
(8) The production date of the batch.
(9) The fuel type of the batch.
(10) The volume of the batch.
(11) The volume of ethanol denaturant and applicable equivalence
value of each batch.
(12) Quantity of RINs generated for the batch.
(13) The type and quantity of feedstock(s) used for the batch.
(14) An affirmation that the feedstock(s) used for each batch meets
the definition of renewable biomass.
(15) The type and quantity of co-products produced with the batch of
renewable fuel.
(16) The type and quantity of each biointermediate used for the
batch, if applicable.
(17) The EPA facility registration number of each biointermediate
production facility at which a biointermediate used for the batch was
produced, if applicable.
(18) Any additional information that EPA may require.
(c) Starting July 1, 2010, each time any party sells, separates, or
retires RINs generated on or after July 1, 2010, all the following
information must be submitted to EPA via the submitting party's EMTS
account within five (5) business days of the reportable event. Starting
July 1, 2010, each time any party purchases RINs generated on or after
July 1, 2010, all the following information must be submitted to EPA via
the submitting party's EMTS account within ten (10) business days of the
reportable event. The reportable event for a RIN purchase or sale occurs
on the date of transfer per Sec. 80.1453(a)(4). The reportable event
for a RIN separation or retirement occurs on the date of separation or
retirement as described in Sec. 80.1429 or Sec. 80.1434.
(1) The submitting party's name.
(2) The submitting party's EPA company registration number.
(3) The generation year of the RINs.
(4) The RIN status (Assigned or Separated).
[[Page 214]]
(5) The D code of the RINs.
(6) Transaction type (i.e., RIN buy, RIN sell, RIN separation, RIN
retire).
(7) The date of transfer per Sec. 80.1453(a)(4), if applicable.
(8) For a RIN purchase or sale, the trading partner's name.
(9) For a RIN purchase or sale, the trading partner's EPA company
registration number.
(10) For an assigned RIN purchase or sale, the renewable fuel volume
associated with the sale.
(11) Quantity of RINs involved in a transaction.
(12)(i) For transactions through December 31, 2019, the per gallon
RIN price or the per-gallon price of renewable fuel with RINs included.
(ii) For transactions on or after January 1, 2020:
(A) For RIN buy or sell transaction types including assigned RINs,
the per-gallon RIN price or the per-gallon price of renewable fuel with
RINs included.
(B) For RIN buy or sell transaction types including separated RINs,
the per-gallon RIN price.
(13) The reason for retiring RINs, separating RINs, buying RINs, or
selling RINs.
(14) Any additional information that EPA may require.
(15) For buy or sell transactions of separated RINs on or after
January 1, 2020, the mechanism used to purchase the RINs (e.g., spot
market or fulfilling a term contract).
(d) All information required under this section shall be submitted
on forms and following procedures prescribed by EPA.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 79978, Dec. 21, 2010;
77 FR 1357, Jan. 9, 2012; 84 FR 27024, June 10, 2019; 85 FR 7079, Feb.
6, 2020; 87 FR 39669, July 1, 2022; 88 FR 44589, July 12, 2023]
Sec. 80.1453 What are the product transfer document (PTD) requirements
for the RFS program?
(a) On each occasion when any party transfers ownership of neat or
blended renewable fuels or RNG, except when such fuel is dispensed into
motor vehicles or nonroad vehicles, engines, or equipment, or separated
RINs subject to this subpart, the transferor must provide to the
transferee documents that include all the following information, as
applicable:
(1) The name and address of the transferor and transferee.
(2) The transferor's and transferee's EPA company registration
numbers.
(3) The volume of renewable fuel that is being transferred, if any.
(4) The date of the transfer.
(5) [Reserved]
(6) The quantity of RINs being traded.
(7) The D code of the RINs.
(8) The RIN status (Assigned or Separated).
(9) The RIN generation year.
(10) The associated reason for the sell or buy transaction (e.g.,
standard trade or remedial action).
(11) Additional RIN-related information, as follows:
(i) If assigned RINs are being transferred on the same PTD used to
transfer ownership of the renewable fuel, then the assigned RIN
information shall be identified on the PTD.
(A) The identifying information for a RIN that is transferred in
EMTS generically is the information specified in paragraphs (a)(1)
through (a)(10) of this section.
(B) The identifying information for a RIN that is transferred in
EMTS uniquely is the information specified in paragraphs (a)(1) through
(a)(10) of this section, the RIN generator company ID, the RIN generator
facility ID, and the batch number.
(C) The identifying information for a RIN that is generated prior to
July 1, 2010, is the 38-digit code pursuant to Sec. 80.1425, in its
entirety.
(ii) If assigned RINs are being transferred on a separate PTD from
that which is used to transfer ownership of the renewable fuel, then the
PTD which is used to transfer ownership of the renewable fuel shall
include all the following:
(A) The number of gallon-RINs being transferred.
(B) A unique reference to the PTD which is transferring the assigned
RINs.
(C) The information specified in paragraphs (a)(11)(i)(A) through
(a)(11)(i)(C) of this section, as appropriate.
(iii) If no assigned RINs are being transferred with the renewable
fuel,
[[Page 215]]
the PTD which is used to transfer ownership of the renewable fuel shall
state ``No assigned RINs transferred.''.
(iv) If RINs have been separated from the renewable fuel or fuel
blend pursuant to Sec. 80.1429(b)(4), then all PTDs which are at any
time used to transfer ownership of the renewable fuel or fuel blend
shall state ``This volume of fuel must be used in the designated form,
without further blending.''.
(12) For the transfer of renewable fuel or RNG for which RINs were
generated, an accurate and clear statement on the product transfer
document of the fuel type from the approved pathway, and designation of
the fuel use(s) intended by the transferor, as follows:
(i) Ethanol. ``This volume of neat or blended ethanol is designated
and intended for use as transportation fuel or jet fuel in the 48 U.S.
contiguous states and Hawaii. Any person exporting this fuel is subject
to the requirements of 40 CFR 80.1430.''.
(ii) Biodiesel. ``This volume of neat or blended biodiesel is
designated and intended for use as transportation fuel, heating oil or
jet fuel in the 48 U.S. contiguous states and Hawaii. Any person
exporting this fuel is subject to the requirements of 40 CFR 80.1430.''.
(iii) Renewable heating oil. ``This volume of heating oil is
designated and intended for use as heating oil in the 48 U.S. contiguous
states and Hawaii. Any person exporting this fuel is subject to the
requirements of 40 CFR 80.1430.''.
(iv) Renewable diesel. ``This volume of neat or blended renewable
diesel is designated and intended for use as transportation fuel,
heating oil or jet fuel in the 48 U.S. contiguous states and Hawaii. Any
person exporting this fuel is subject to the requirements of 40 CFR
80.1430.''.
(v) Naphtha. ``This volume of neat or blended naphtha is designated
and intended for use as transportation fuel or jet fuel in the 48 U.S.
contiguous states and Hawaii. This naphtha may only be used as a
gasoline blendstock, E85 blendstock, or jet fuel. Any person exporting
this fuel is subject to the requirements of 40 CFR 80.1430.''.
(vi) Butanol. ``This volume of neat or blended butanol is designated
and intended for use as transportation fuel or jet fuel in the 48 U.S.
contiguous states and Hawaii. This butanol may only be used as a
gasoline blendstock or jet fuel. Any person exporting this fuel is
subject to the requirements of 40 CFR 80.1430.''.
(vii) Renewable fuels other than ethanol, biodiesel, heating oil,
renewable diesel, naptha or butanol. ``This volume of neat or blended
renewable fuel is designated and intended to be used as transportation
fuel, heating oil, or jet fuel in the 48 U.S. contiguous states and
Hawaii. Any person exporting this fuel is subject to the requirements of
40 CFR 80.1430.''.
(viii) RNG. ``This volume of RNG is designated and intended for
transportation use in the 48 U.S. contiguous states and Hawaii or as a
feedstock to produce a renewable fuel and may not be used for any other
purpose. Any person exporting this fuel is subject to the requirements
of 40 CFR 80.1430. Assigned RINs to this volume of RNG must not be
separated unless the RNG is used as transportation fuel in the 48 U.S.
contiguous states and Hawaii.''
(b) Except for transfers to truck carriers, retailers, or wholesale
purchaser-consumers, product codes may be used to convey the information
required under paragraphs (a)(1) through (11) and (e) of this section if
such codes are clearly understood by each transferee.
(c) For renewable fuel, other than ethanol, that is not registered
as motor vehicle fuel under 40 CFR Part 79, the PTD which is used to
transfer ownership of the renewable fuel shall state ``This volume of
renewable fuel may not be used as a motor vehicle fuel.''
(d) For fuel oil meeting paragraph (2) of the definition of
``heating oil'' in Sec. 80.2, the PTD of the fuel oil shall state:
``This volume of renewable fuel oil is designated and intended to be
used to heat or cool interior spaces of homes or buildings to control
ambient climate for human comfort. Do NOT use for process heat or
cooling or any other purpose, as these uses are prohibited pursuant to
40 CFR 80.1460(g).''.
(e) Beginning January 1, 2021, on each occasion when any party
transfers custody or ownership of certified NTDF, except when such fuel
is dispensed into motor vehicles or nonroad vehicles, engines, or
equipment, the transferor
[[Page 216]]
must provide to the transferee documents that include all the following
information, as applicable:
(1) The transferor of certified NTDF must list all applicable
required information as specified at 40 CFR 1090.1115 and, if the
distillate fuel contains renewable fuel, all applicable required
information in paragraphs (a), (b), and (d) of this section.
(2) The transferor must include the following statement on the PTD:
``15 ppm sulfur (maximum) certified NTDF--This fuel is designated for
non-transportation use.''
(f)(1) On each occasion when any party transfers title or custody of
a biointermediate, the transferor must provide to the transferee
documents that include all of the following information:
(i) The name and address of the transferor and transferee.
(ii) The transferor's and transferee's EPA company registration and
applicable facility registration numbers.
(iii) The volume of biointermediate that is being transferred.
(iv) The date of the transfer.
(v) The location of the biointermediate at the time of the transfer.
(vi) The following statement designating the volume of
biointermediate as feedstock for the production of a renewable fuel:
``This volume is designated and intended for use as biointermediate in
the production of renewable fuel as defined in Sec. 80.2. Parties may
not generate RINs on this feedstock material and it must remain
segregated from all products until received by a designated renewable
fuel production facility.''
(vii) For biogas designated for use as a biointermediate, any
applicable PTD requirements under Sec. 80.150.
(2) In addition to the information specified in paragraph (f)(1) of
this section, on each occasion when any party transfers title of a
biointermediate or when any party transfers a biointermediate to a
renewable fuel production facility, the transferor must provide to the
transferee documents that include all of the following information:
(i) The renewable fuel type the biointermediate was designated to be
used as a feedstock material for by the biointermediate producer under
Sec. 80.1476(i).
(ii) The composition of the biointermediate being transferred,
including:
(A) The type and quantity of each feedstock that was used to make
the biointermediate.
(B) The percentage of each feedstock that is renewable biomass,
rounded to two decimal places.
(C) For a biointermediate that contains both renewable and non-
renewable feedstocks:
(1) The percentage of each feedstock that is not renewable biomass,
rounded to two decimal places.
(2) The feedstock energy from the renewable biomass used to make the
biointermediate, in Btu.
(3) The feedstock energy from the non-renewable biomass used to make
the biointermediate, in Btu.
(4) The total percentage of the biointermediate that may generate
RINs, rounded to two decimal places.
(5) The total percentage of the biointermediate that may not
generate RINs, rounded to two decimal places.
(D) For a biointermediate that contains cellulosic material:
(1) The percentage of each feedstock that is cellulosic, rounded to
two decimal places.
(2) The percentage of each feedstock that is non-cellulosic, rounded
to two decimal places, if applicable.
(3) If the biointermediate is intended for use in the production of
a cellulosic biofuel, the total percentage of the biointermediate that
may generate cellulosic RINs, rounded to two decimal places.
(4) For separated municipal solid waste, the cellulosic portion of
the biointermediate is equivalent to the biogenic portion.
(5) For separated food waste, the non-cellulosic percentage is
assumed to be zero percent unless it is demonstrated to be partially
cellulosic.
(6) For separated yard waste, 100% of separated yard waste is deemed
to be cellulosic.
(7) The following statement: ``I certify that the cellulosic content
of this feedstock was derived from cellulose, hemicellulose, or lignin
that was derived from renewable biomass.''
[[Page 217]]
(iii) Copies of records specified in Sec. 80.1454(i)(3), (5), and
(6) for the volume being transferred, as applicable.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26045, May 10, 2010; 78
FR 62471, Oct. 22, 2013; 79 FR 42118, July 18, 2014; 81 FR 23645, Apr.
22, 2016; 85 FR 7079, Feb. 6, 2020; 85 FR 78467, Dec. 4, 2020; 87 FR
39669, July 1, 2022; 88 FR 44589, July 12, 2023]
Sec. 80.1454 What are the recordkeeping requirements under the RFS
program?
(a) Requirements for obligated parties and exporters of renewable
fuel. Beginning July 1, 2010, any obligated partyor exporter of
renewable fuel must keep all of the following records:
(1) Product transfer documents consistent with Sec. 80.1453 and
associated with the obligated party's or exporter of renewable fuel's
activity, if any, as transferor or transferee of renewable fuel or
separated RINs.
(2) Copies of all reports submitted to EPA under Sec. 80.1451(a),
as applicable.
(3) Records related to each RIN transaction, including all of the
following:
(i) A list of the RINs owned, purchased, sold, separated, retired,
or reinstated.
(ii) The parties involved in each RIN transaction including the
transferor, transferee, and any broker or agent.
(iii) The date of the transfer of the RIN(s).
(iv) Additional information, including contracts, correspondence,
and invoices, related to details of the RIN transaction and its terms.
(4) Records related to the use of RINs (by facility, if applicable)
for compliance, including all of the following:
(i) Methods and variables used to calculate the Renewable Volume
Obligations pursuant to Sec. 80.1407 or Sec. 80.1430.
(ii) List of RINs used to demonstrate compliance.
(iii) Additional information related to details of RIN use for
compliance.
(5) Records related to the separation of assigned RINs from
renewable fuel volume.
(6) For exported renewable fuel, invoices, bills of lading and other
documents describing the exported renewable fuel.
(i) For exporters of renewable fuel for which no RINs were
generated, an affidavit signed by the producer of the exported renewable
fuel affirming that no RINs were generated for that volume of renewable
fuel.
(ii) [Reserved]
(7) Any obligated party that uses the provisions of Sec. 80.1444
for a small refinery must keep the following records:
(i) Copies of any notifications submitted to EPA under Sec.
80.1444(e)(2).
(ii) Copies of the methods and variables used to calculate the
number of RINs retired for the alternative RIN retirement schedule under
Sec. 80.1444(f).
(b) Requirements for all producers of renewable fuel. Beginning July
1, 2010, any domestic or RIN-generating foreign producer of a renewable
fuel must keep all of the following records in addition to those
required under paragraphs (c) or (d) of this section:
(1) Product transfer documents consistent with Sec. 80.1453 and
associated with the renewable fuel producer's activity, if any, as
transferor or transferee of renewable fuel or separated RINs.
(2) Copies of all reports submitted to EPA under Sec. Sec. 80.1449
and 80.1451(b).
(3) Records related to the generation and assignment of RINs for
each facility, including all of the following:
(i) Batch volume in gallons.
(ii) Batch number.
(iii) RIN as assigned under Sec. 80.1426, if applicable.
(iv) Identification of batches by renewable category.
(v) Type and quantity of co-products produced.
(vi) Type and quantity of feedstocks used.
(vii) Type and quantity of biointermediates used.
(viii) Type and quantity of fuel used for process heat.
(ix) All facility-determined values used in the calculations under
Sec. 80.1426(f)(4) and the data used to obtain those values.
(x) Date of production.
(xi) Results of any laboratory analysis of batch chemical
composition or physical properties.
(xii) For RINs generated for ethanol produced from corn starch at a
facility using an approved pathway that requires the use of one or more
of the advanced technologies listed in Table 2 to
[[Page 218]]
Sec. 80.1426, documentation to demonstrate that employment of the
required advanced technology or technologies was conducted in accordance
with the specifications in the approved pathway and Table 2 to Sec.
80.1426, including any requirement for application to 90% of the
production on a calendar year basis.
(xiii) All commercial documents and additional information related
to details of RIN generation.
(4) Records related to each RIN transaction, separately for each
transaction, including all of the following:
(i) A list of the RINs owned, purchased, sold, separated, retired,
or reinstated.
(ii) The parties involved in each transaction including the
transferor, transferee, and any broker or agent.
(iii) The date of the transfer of the RIN(s).
(iv) Additional information related to details of the transaction
and its terms.
(5) Records related to the production, importation, ownership, sale
or use of any volume of renewable fuel for which RINs were generated or
blend of renewable fuel for which RINs were generated and gasoline or
diesel fuel that any party designates for use as transportation fuel,
jet fuel, or heating oil and the use of the fuel or blend as
transportation fuel, jet fuel, or heating oil without further blending,
in the designated form.
(6) Copies of registration documents required under Sec. 80.1450,
including information on fuels and products, feedstocks,
biointermediates, facility production processes, process changes, and
capacity, energy sources, and a copy of the independent third party
engineering review report submitted to EPA per Sec. 80.1450(b)(2).
(7) For any producer of renewable fuel made from Arundo donax or
Pennisetum purpureum per Sec. 80.1426(f)(14), all the following:
(i) Records related to all requirements and duties set forth in the
registration documents described in Sec. 80.1450(b)(1)(x)(A), including
but not limited to the Risk Mitigation Plan, monitoring records and
reports, and adherence to state, local and federal invasive species
requirements and permits.
(ii) Records associated with feedstock purchases and transfers that
identify where the feedstocks were produced and are sufficient to verify
that feedstocks used were produced and transported in accordance with an
EPA approved Risk Mitigation Plan or were produced on land that the EPA
determined does not present a significant likelihood of invasive spread
beyond the planting area of the feedstock used for production of the
renewable fuel, including all the following:
(A) Maps or electronic data identifying the boundaries of the land
where each type of feedstock was produced.
(B) Bills of lading, product transfer documents, or other commercial
documents showing the quantity of feedstock purchased from each area
identified above, and showing each transfer of custody of the feedstock
from the location where it was produced to the renewable fuel production
facility.
(8) A producer of fuel oil meeting paragraph (2) of the definition
of heating oil in Sec. 80.2 shall keep copies of all contracts which
describe the fuel oil under contract with each end user.
(9) Records, including contracts, related to the implementation of a
QAP under Sec. 80.1469.
(10) Records related to any volume of renewable fuel where RINs were
not generated by the renewable fuel producer or importer pursuant to
Sec. 80.1426(c).
(c) Additional requirements for imports of renewable fuel. (1)
Beginning July 1, 2010, any RIN-generating foreign producer of a
renewable fuel or RIN-generating importer must keep records of feedstock
purchases and transfers associated with renewable fuel for which RINs
are generated, sufficient to verify that feedstocks used are renewable
biomass.
(i) RIN-generating foreign producers and importers of renewable fuel
made from feedstocks that are planted crops or crop residue from
existing foreign agricultural land, planted trees or tree residue from
actively managed tree plantations, slash and pre-commercial thinnings
from forestlands or biomass obtained from wildland-urban interface must
maintain all the following
[[Page 219]]
records to verify the location where these feedstocks were produced:
(A) Maps or electronic data identifying the boundaries of the land
where each type of feedstock was produced.
(B) Bills of lading, product transfer documents, or other commercial
documents showing the quantity of feedstock purchased from each area
identified in paragraph (c)(1)(i)(A) of this section, and showing each
transfer of custody of the feedstock from the location where it was
produced to the renewable fuel production facility.
(ii)(A) RIN-generating foreign producers and importers of renewable
fuel made from planted crops or crop residue from existing foreign
agricultural land must keep records that serve as evidence that the land
from which the feedstock was obtained was cleared or cultivated prior to
December 19, 2007 and actively managed or fallow, and nonforested on
December 19, 2007. RIN-generating foreign producers or importers of
renewable fuel made from planted trees or tree residue from actively
managed tree plantations must keep records that serve as evidence that
the land from which the feedstock was obtained was cleared prior to
December 19, 2007 and actively managed on December 19, 2007.
(B) The records must be provided by the feedstock producer,
traceable to the land in question, and consist of at least one of the
following documents:
(1) Sales records for planted crops or trees, crop or tree residue,
or livestock; purchasing records for fertilizer, weed control, or
reseeding, including seeds, seedlings, or other nursery stock.
(2) A written management plan for agricultural or silvicultural
purposes; documentation of participation in an agricultural or
silvicultural program sponsored by a Federal, state, or local government
agency.
(3) Documentation of land management in accordance with an
agricultural or silvicultural product certification program, an
agreement for land management consultation with a professional forester
that identifies the land in question.
(4) Evidence of the existence and ongoing maintenance of a road
system or other physical infrastructure designed and maintained for
logging use, together with one of the aforementioned documents in this
paragraph (c)(1)(ii)(B).
(iii) RIN-generating foreign producers and importers of renewable
fuel made from any other type of renewable biomass must have documents
from their feedstock supplier certifying that the feedstock qualifies as
renewable biomass, describing the feedstock and identifying the process
that was used to generate the feedstock.
(2) Beginning July 1, 2010, any RIN-generating importer of renewable
fuel must keep all of the following records:
(i) Product transfer documents consistent with Sec. 80.1453 and
associated with the renewable fuel importer's activity, if any, as
transferor or transferee of renewable fuel.
(ii) Copies of all reports submitted to EPA under Sec. Sec. 80.1449
and 80.1451(b).
(iii) Records related to the generation and assignment of RINs for
each facility, including all of the following:
(A) Batch volume in gallons.
(B) Batch number.
(C) RIN as assigned under Sec. 80.1426.
(D) Identification of batches by renewable category.
(E) Type and quantity of feedstocks used.
(F) Type and quantity of fuel used for process heat.
(G) Date of import.
(H) Results of any laboratory analysis of batch chemical composition
or physical properties.
(I) The EPA registration number of the foreign renewable fuel
producers producing the fuel.
(J) Additional information related to details of RIN generation.
(iv) Records related to each RIN transaction, including all of the
following:
(A) A list of the RINs owned, purchased, sold, separated, retired,
or reinstated.
(B) The parties involved in each transaction including the
transferor, transferee, and any broker or agent.
(C) The date of the transfer of the RIN(s).
(D) Additional information related to details of the transaction and
its terms.
(v) Copies of registration documents required under Sec. 80.1450.
[[Page 220]]
(vi) Records related to the import of any volume of renewable fuel
that the importer designates for use as transportation fuel, jet fuel,
or heating oil.
(vii) For renewable fuel or biointermediate produced from a type of
renewable biomass not specified in paragraphs (c)(1)(i) through (vi) of
this section, documents from their feedstock suppliers and feedstock
aggregators, as applicable, certifying that the feedstock qualifies as
renewable biomass, describing the feedstock.
(3) Producers of renewable fuel or biointermediate produced from
separated yard and food waste, biogenic oils/fats/greases, or separated
MSW must comply with either the recordkeeping requirements in paragraph
(j) of this section or the alternative recordkeeping requirements in
Sec. 80.1479.
(d) Additional requirements for domestic producers of renewable
fuel. (1) Except as provided in paragraphs (g) and (h) of this section,
any domestic producer of renewable fuel that generates RINs for such
fuel must keep documents associated with feedstock purchases and
transfers that identify where the feedstocks were produced and are
sufficient to verify that feedstocks used are renewable biomass if RINs
are generated.
(2) Domestic producers of renewable fuel made from feedstocks that
are planted trees or tree residue from actively managed tree
plantations, slash and pre-commercial thinnings from forestlands or
biomass obtained from areas at risk of wildfire must maintain all the
following records to verify the location where these feedstocks were
produced:
(i) Maps or electronic data identifying the boundaries of the land
where each type of feedstock was produced.
(ii) Bills of lading, product transfer documents or other commercial
documents showing the quantity of feedstock purchased from each area
identified in paragraph (d)(2)(i) of this section, and showing each
transfer of custody of the feedstock from the location where it was
produced to the renewable fuel production facility.
(3) Domestic producers of renewable fuel made from planted trees or
tree residue from actively managed tree plantations must keep records
that serve as evidence that the land from which the feedstock was
obtained was cleared prior to December 19, 2007 and actively managed on
December 19, 2007. The records must be provided by the feedstock
producer and must include at least one of the following documents, which
must be traceable to the land in question:
(i) Sales records for planted trees or tree residue.
(ii) Purchasing records for fertilizer, weed control, or reseeding,
including seeds, seedlings, or other nursery stock.
(iii) A written management plan for silvicultural purposes.
(iv) Documentation of participation in a silvicultural program
sponsored by a Federal, state, or local government agency.
(v) Documentation of land management in accordance with a
silvicultural product certification program, an agreement for land
management consultation with a professional forester.
(vi) Evidence of the existence and ongoing maintenance of a road
system or other physical infrastructure designed and maintained for
logging use, together with one of the aforementioned documents.
(4) Domestic producers of renewable fuel made from planted crops or
crop residue from existing foreign agricultural land must keep all the
following records:
(i) Records that serve as evidence that the land from which the
feedstock was obtained was cleared or cultivated prior to December 19,
2007 and actively managed or fallow, and nonforested on December 19,
2007. The records must be provided by the feedstock producer and must
include at least one of the following documents, which must be traceable
to the land in question:
(A) Sales records for planted crops, crop residue, or livestock.
(B) Purchasing records for fertilizer, weed control, seeds,
seedlings, or other nursery stock.
(C) A written management plan for agricultural purposes.
(D) Documentation of participation in an agricultural program
sponsored by a Federal, State, or local government agency.
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(E) Documentation of land management in accordance with an
agricultural product certification program.
(ii) Records to verify the location where the feedstocks were
produced:
(A) Maps or electronic data identifying the boundaries of the land
where each type of feedstock was produced; and
(B) Bills of lading, product transfer documents or other commercial
documents showing the quantity of feedstock purchased from each area
identified in paragraph (d)(4)(ii)(A) of this section, and showing each
transfer of custody of the feedstock from the location where it was
produced to the renewable fuel facility.
(5) Domestic producers of renewable fuel or biointermediates
produced from a type of renewable biomass not specified in paragraphs
(d)(2) through (4) of this section must have documents from their
feedstock suppliers and feedstock aggregators, as applicable, certifying
that the feedstock qualifies as renewable biomass, describing the
feedstock.
(6) Producers of renewable fuel or biointermediate produced from
separated yard and food waste, biogenic oils/fats/greases, or separated
MSW must comply with either the recordkeeping requirements in paragraph
(j) of this section or the alternative recordkeeping requirements in
Sec. 80.1479.
(e) Additional requirements for producers of fuel exempt from the
20% GHG reduction requirement. Beginning July 1, 2010, any production
facility with a baseline volume of fuel that is not subject to the 20%
GHG threshold, pursuant to Sec. 80.1403(c) and (d), must keep all of
the following:
(1) Detailed engineering plans for the facility.
(2) Federal, State, and local (or foreign governmental)
preconstruction approvals and permitting.
(3) Procurement and construction contracts and agreements.
(f) Requirements for other parties that own RINs. Beginning July 1,
2010, any party, other than those parties covered in paragraphs (a) and
(b) of this section, that owns RINs must keep all of the following
records:
(1) Product transfer documents consistent with Sec. 80.1453 and
associated with the party's activity, if any, as transferor or
transferee of renewable fuel or separated RINs.
(2) Copies of all reports submitted to EPA under Sec. 80.1451(c).
(3) Records related to each RIN transaction by renewable fuel
category, including all of the following:
(i) A list of the RINs owned, purchased, sold, separated, retired,
or reinstated.
(ii) The parties involved in each RIN transaction including the
transferor, transferee, and any broker or agent.
(iii) The date of the transfer of the RIN(s).
(iv) Additional information related to details of the transaction
and its terms.
(4) Records related to any volume of renewable fuel that the party
designated for use as transportation fuel, jet fuel, or heating oil and
from which RINs were separated pursuant to Sec. 80.1429(b)(4).
(g) Aggregate compliance with renewable biomass requirement. Any
producer or RIN-generating importer of renewable fuel made from planted
crops or crop residue from existing U.S. agricultural land as defined in
Sec. 80.1401, or from planted crops or crop residue from existing
agricultural land in a country covered by a petition approved pursuant
to Sec. 80.1457, is covered by the aggregate compliance approach and is
not subject to the recordkeeping requirements for planted crops and crop
residue at Sec. 80.1454(g)(2) unless EPA publishes a finding that the
2007 baseline amount of agricultural land in the U.S. has been exceeded
or, for the aggregate compliance approach in a foreign country, that the
withdrawal of EPA approval of the aggregate compliance approach is
warranted pursuant to Sec. 80.1457(e).
(1) EPA will make findings concerning whether the 2007 baseline
amount of agricultural land in the U.S. or other country covered by a
petition approved pursuant to Sec. 80.1457 has been exceeded and will
publish these findings in the Federal Register by November 30 of the
year preceding the compliance period.
(2) If EPA finds that the 2007 baseline amount of agricultural land
in the U.S. or other country covered by a petition approved pursuant to
Sec. 80.1457 has been
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exceeded, beginning on the first day of July of the compliance period in
question any producer or RIN-generating importer of renewable fuel made
from planted crops or crop residue in the country for which such a
finding is made must keep all the following records:
(i) Records that serve as evidence that the land from which the
feedstock was obtained was cleared or cultivated prior to December 19,
2007 and actively managed or fallow, and nonforested on December 19,
2007. The records must be provided by the feedstock producer and must
include at least one of the following documents, which must be traceable
to the land in question:
(A) Sales records for planted crops, crop residue or livestock.
(B) Purchasing records for fertilizer, weed control, seeds,
seedlings, or other nursery stock.
(C) A written management plan for agricultural purposes.
(D) Documentation of participation in an agricultural program
sponsored by a Federal, state, or local government agency.
(E) Documentation of land management in accordance with an
agricultural product certification program.
(ii) Records to verify the location where the feedstocks were
produced:
(A) Maps or electronic data identifying the boundaries of the land
where each type of feedstock was produced; and
(B) Bills of lading, product transfer documents or other commercial
documents showing the quantity of feedstock purchased from each area
identified in paragraph (g)(2)(ii)(A) of this section, and showing each
transfer of custody of the feedstock from the location where it was
produced to the renewable fuel facility.
(h) Alternative renewable biomass tracking requirement. Any foreign
or domestic renewable fuel producer or RIN-generating importer may
comply with the following alternative renewable biomass tracking
requirement instead of the recordkeeping requirements in paragraphs
(c)(1), (d), and (g) of this section:
(1) To comply with the alternative renewable biomass tracking
requirement under this paragraph (h), a renewable fuel producer or
importer must either arrange to have an independent third party conduct
a comprehensive program of annual compliance surveys, or participate in
the funding of an organization which arranged to have an independent
third party conduct a comprehensive program of annual compliance
surveys, to be carried out in accordance with a survey plan which has
been approved by EPA.
(2) The annual compliance surveys under this paragraph (h) must be
all the following:
(i) Planned and conducted by an independent surveyor that meets the
requirements in 40 CFR 1090.55.
(ii) Conducted at renewable fuel production and import facilities
and their feedstock suppliers.
(iii) Representative of all renewable fuel producers and importers
in the survey area and representative of their feedstock suppliers.
(iv) Designed to achieve at least the same level of quality
assurance required in paragraphs (c)(1), (d) and (g) of this section.
(3) The compliance survey program shall require the independent
surveyor conducting the surveys to do all the following:
(i) Conduct feedstock audits of renewable fuel production and import
facilities in accordance with the survey plan approved under this
paragraph (h), or immediately notify EPA of any refusal of these
facilities to allow an audit to be conducted.
(ii) Obtain the records and product transfer documents associated
with the feedstocks being audited.
(iii) Determine the feedstock supplier(s) that supplied the
feedstocks to the renewable fuel producer.
(iv) Confirm that feedstocks used to produce RIN-generating
renewable fuels meet the definition of renewable biomass.
(v) Immediately notify EPA of any case where the feedstocks do not
meet the definition of renewable biomass.
(vi) Immediately notify EPA of any instances where a renewable fuel
producer, importer or feedstock supplier subject to review under the
approved plan fails to cooperate in the manner described in this
section.
[[Page 223]]
(vii) Submit to EPA a report of each survey, within thirty days
following the completion of each survey, such report to include all the
following information:
(A) The identification of the person who conducted the survey.
(B) An attestation by the officer of the surveyor company that the
survey was conducted in accordance with the survey plan and the survey
results are accurate.
(C) Identification of the parties for whom the survey was conducted.
(D) Identification of the covered area surveyed.
(E) The dates on which the survey was conducted.
(F) The address of each facility at which the survey audit was
conducted and the date of the audit.
(G) A description of the methodology used to select the locations
for survey audits and the number of audits conducted.
(viii) Maintain all records relating to the survey audits conducted
under this section (h) for a period of at least 5 years.
(ix) At any time permit any representative of EPA to monitor the
conduct of the surveys, including observing audits, reviewing records,
and analysis of the audit results.
(4) A survey plan under this paragraph (h) must include all the
following:
(i) Identification of the parties for whom the survey is to be
conducted.
(ii) Identification of the independent surveyor.
(iii) A methodology for determining all the following:
(A) When the audits will be conducted.
(B) The audit locations.
(C) The number of audits to be conducted during the annual
compliance period.
(iv) Any other elements determined by EPA to be necessary to achieve
the level of quality assurance required under paragraphs (c)(1), (d),
and (g) of this section.
(5)(i) Each renewable fuel producer and importer who participates in
the alternative renewable biomass tracking under this paragraph (h) must
take all reasonable steps to ensure that each feedstock producer,
aggregator, distributor, or supplier cooperates with this program by
allowing the independent surveyor to audit their facility and by
providing to the independent surveyor and/or EPA, upon request, copies
of management plans, product transfer documents, and other records or
information regarding the source of any feedstocks received.
(ii) Reasonable steps under paragraph (h)(5)(i) of this section must
include, but typically should not be limited to: Contractual agreements
with feedstock producers, aggregators, distributors, and suppliers,
which require them to cooperate with the independent surveyor and/or EPA
in the manner described in paragraph (h)(5)(i) of this section.
(6) The procedure for obtaining EPA approval of a survey plan under
this paragraph (h), and for revocation of any such approval, are as
follows:
(i) A detailed survey plan which complies with the requirements of
this paragraph (h) must be submitted to EPA, no later than September 1
of the year preceding the calendar year in which the surveys will be
conducted.
(ii) The survey plan must be signed by a responsible corporate
officer of the renewable fuel producer or importer, or responsible
officer of the organization which arranges to have an independent
surveyor conduct a program of renewable biomass compliance surveys, as
applicable.
(iii) The survey plan must be sent to the attention of ``RFS
Program'' to the address in Sec. 80.10(a).
(iv) EPA will send a letter to the party submitting a survey plan
under this section, either approving or disapproving the survey plan.
(v) EPA may revoke any approval of a survey plan under this section
for cause, including an EPA determination that the approved survey plan
had proved inadequate in practice or that it was not fully implemented.
(7)(i) No later than December 1 of the year preceding the year in
which the surveys will be conducted, the contract with the independent
surveyor shall be in effect, and an amount of money necessary to carry
out the entire survey plan shall be paid to the independent
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surveyor or placed into an escrow account with instructions to the
escrow agent to pay the money to the independent surveyor during the
course of the conduct of the survey plan.
(ii) No later than December 15 of the year preceding the year in
which the surveys will be conducted, EPA must receive a copy of the
contract with the independent surveyor, proof that the money necessary
to carry out the survey plan has either been paid to the independent
surveyor or placed into an escrow account, and, if placed into an escrow
account, a copy of the escrow agreement, to be sent to the official
designated in paragraph (h)(6)(iii) of this section.
(8) A failure of any renewable fuel producers or importer to fulfill
or cause to be fulfilled any of the requirements of this paragraph (h)
will cause the option for such party to use the alternative quality
assurance requirements under this paragraph (h) to be void ab initio.
(i) Requirements for biointermediate producers. In addition to any
other applicable records a biointermediate producer must maintain under
this section, any biointermediate producer producing a biointermediate
must keep all of the following records:
(1) Product transfer documents consistent with Sec. 80.1453(f) and
associated with the biointermediate producer's activities, if any, as
transferor or transferee of biointermediates.
(2) Copies of all reports submitted to EPA under Sec. 80.1451(i).
(3) Records related to the production of biointermediates for each
biointermediate production facility, including all of the following:
(i) Batch volume.
(ii) Batch number.
(iii) Type and quantity of co-products produced.
(iv) Type and quantity of feedstocks used.
(v) Type and quantity of fuel used for process heat.
(vi) Calculations per Sec. 80.1426(f), as applicable.
(vii) Date of production.
(viii) Results of any laboratory analysis of batch chemical
composition or physical properties.
(4) Copies of registration documents required under Sec. 80.1450,
including information on products, feedstocks, facility production
processes, process changes, and capacity, energy sources, and a copy of
the independent third party engineering review submitted to EPA per
Sec. 80.1450(b)(2)(i).
(5) Records demonstrating that feedstocks are renewable biomass, as
required under paragraphs (d), (g), (h), and (j) of this section, as
applicable.
(6) For any biointermediate made from Arundo donax or Pennisetum
purpureum per Sec. 80.1426(f)(14), all applicable records described in
paragraph (b)(7) of this section.
(7) Records, including contracts, related to the implementation of a
QAP under Sec. Sec. 80.1469 and 80.1477.
(j) Additional requirements for producers that use separated yard
waste, separate food waste, separated MSW, or biogenic waste oils/fats/
greases. Except for parties complying with the alternative recordkeeping
requirements in Sec. 80.1479, a renewable fuel or biointermediate
producer that produces fuel or biointermediate from separated yard
waste, separated food waste, separated MSW, or biogenic waste oils/fats/
greases must keep all the following additional records:
(1) For separated yard waste, separated food waste, and biogenic
waste oils/fats/greases:
(i) Documents demonstrating the amounts, by weight, purchased of
separated yard waste, separated food waste, or biogenic waste oils/fats/
greases for use as a feedstock in producing renewable fuel.
(ii) Documents demonstrating the location of any establishment(s)
from which the waste stream consisting solely of separated yard waste,
separated food waste, or biogenic waste oils/fats/greases is collected.
(iii) Such other records as may be requested by EPA.
(2) For separated municipal solid waste:
(i) Contracts and documents memorializing the sale of paper,
cardboard, plastics, rubber, textiles, metals, and glass separated from
municipal solid waste for recycling.
(ii) Documents demonstrating the amounts by weight purchased of
post-
[[Page 225]]
recycled separated yard and food waste for use as a feedstock in
producing renewable fuel.
(iii) Documents demonstrating the fuel sampling methods used
pursuant to Sec. 80.1426(f)(9) and the results of all fuel analyses to
determine the non-fossil fraction of fuel made from separated municipal
solid waste.
(iv) Such other records as may be requested by EPA.
(k) Additional requirements for producers of renewable fuel using
biogas. (1) Biogas/CNG/LNG and electricity in pathways involving
feedstocks other than grain sorghum. A renewable fuel producer that
generates RINs for renewable CNG, renewable LNG or renewable electricity
pursuant to Sec. 80.1426(f)(10) or (11), or that uses process heat from
biogas to produce renewable fuel pursuant to Sec. 80.1426(f)(12) shall
keep all of the following additional records:
(i) Documentation recording the sale of renewable CNG, renewable LNG
or renewable electricity for use as transportation fuel relied upon in
Sec. 80.1426(f)(10), Sec. 80.1426(f)(11), or for use of biogas for
process heat to make renewable fuel as relied upon in Sec.
80.1426(f)(12) and the transfer of title of the biogas/CNG/LNG or
renewable electricity from the point of biogas production to the
facility which sells or uses the fuel for transportation purposes.
(ii) Documents demonstrating the volume and energy content of
biogas/CNG/LNG, or kilowatts of renewable electricity, relied upon under
Sec. 80.1426(f)(10) that was delivered to the facility which sells or
uses the fuel for transportation purposes.
(iii) Documents demonstrating the volume and energy content of
biogas/CNG/LNG, or kilowatts of renewable electricity, relied upon under
Sec. 80.1426(f)(11), or biogas relied upon under Sec. 80.1426(f)(12)
that was placed into the commercial distribution.
(iv) Documents demonstrating the volume and energy content of biogas
relied upon under Sec. 80.1426(f)(12) at the point of distribution.
(v) Affidavits, EPA-approved documentation, or data from a real-time
electronic monitoring system, confirming that the amount of the biogas/
CNG/LNG or renewable electricity relied upon under Sec. 80.1426(f)(10)
and (11) was used for transportation purposes only, and for no other
purpose. The RIN generator shall obtain affidavits, or monitoring system
data under this paragraph (k), at least once per calendar quarter.
(vi) The biogas or renewable electricity producer's Compliance
Certification required under Title V of the Clean Air Act.
(vii) Any other records as requested by EPA.
(2) Biogas and electricity in pathways involving grain sorghum as
feedstock. A renewable fuel producer that produces fuel pursuant to a
pathway that uses grain sorghum as a feedstock must keep all the
following additional records, as appropriate:
(i) Contracts and documents memorializing the purchase and sale of
biogas and the transfer of biogas from the point of generation to the
ethanol production facility.
(ii) If the advanced biofuel pathway is used, documents
demonstrating the total kilowatt-hours (kWh) of electricity used from
the grid, and the total kWh of grid electricity used on a per gallon of
ethanol basis, pursuant to Sec. 80.1426(f)(13).
(iii) Affidavits from the biogas producer used at the facility, and
all parties that held title to the biogas, confirming that title and
environmental attributes of the biogas relied upon under Sec.
80.1426(f)(13) were used for producing ethanol at the renewable fuel
production facility and for no other purpose. The renewable fuel
producer must obtain these affidavits for each quarter.
(iv) The biogas producer's Compliance Certification required under
Title V of the Clean Air Act.
(v) Such other records as may be requested by EPA.
(l) Additional requirements for producers or importers of any
renewable fuel other than ethanol, biodiesel, renewable gasoline,
renewable diesel, biogas-derived renewable fuel, or renewable
electricity. A renewable fuel producer that generates RINs for any
renewable fuel other than ethanol, biodiesel, renewable gasoline,
renewable diesel that meets the Grade No. 1-D or No. 2-D specification
in
[[Page 226]]
ASTM D975 (incorporated by reference, see Sec. 80.12), biogas-derived
renewable fuel or renewable electricity must keep all the following
additional records:
(1) Documents demonstrating the total volume of renewable fuel
produced, total volume of renewable fuel blended into gasoline and
distillate fuel, and the percentage of renewable fuel in each batch of
finished fuel.
(2) Contracts and documents memorializing the sale of renewable fuel
to parties who blend the fuel into gasoline or diesel fuel to produce a
transportation fuel, heating oil or jet fuel, or who use the renewable
fuel in its neat form for a qualifying fuel use.
(3) For each batch of renewable fuel that generated RINs under Sec.
80.1426(f)(17)(i)(B)(2), one or more affidavits from the party that
blended or used the renewable fuel that includes all the following
information:
(i) Quantity of renewable fuel received from the producer or
importer.
(ii) Date the renewable fuel was received from producer.
(iii) A description of the fuel that the renewable fuel was blended
into and the blend ratios for each batch, if applicable.
(iv) A description of the finished fuel, and a statement that the
fuel meets all applicable standards and was sold for use as a
transportation fuel, heating oil or jet fuel.
(v) Quantity of assigned RINs received with the renewable fuel, if
applicable.
(vi) Quantity of assigned RINs that the end user separated from the
renewable fuel, if applicable.
(4) Such other records as may be requested by EPA.
(m) Requirements for independent third-party auditors. Any
independent third-party auditor (as described at Sec. 80.1471) must
keep all of the following records for a period of at least five years:
(1) Copies of all reports submitted to the EPA under Sec.
80.1451(g), as applicable.
(2) Records related to the implementation of a QAP under Sec.
80.1469 for each facility including records from facility audits and
ongoing and quarterly monitoring activities.
(3) Records related to the verification of RINs under Sec.
80.1471(e).
(4) Copies of communications sent to and received from renewable
fuel producers or foreign renewable fuel producers, feedstock suppliers,
purchasers of RINs, and obligated parties.
(5) Copies of all notes relating to the implementation of a QAP
under Sec. 80.1469.
(6) List of RINs reported to the EPA and renewable fuel producers or
foreign renewable fuel producers as potentially invalidly generated
under Sec. 80.1474 compliance.
(7) Records related to the professional liability insurance
requirement under Sec. 80.1471(c).
(8) Copies of all records related to any financial assurance
instrument as required under Sec. 80.1470 under a quality assurance
plan implemented under Sec. 80.1469(a) during the interim period.
(9) Copies of all records and notifications related to the
identification of a potentially invalid RIN under Sec. 80.1474(b).
(10) Copies of all reports required under Sec. 80.1464.
(11) Such other records as may be requested by EPA.
(n) Additional requirements for producers of renewable fuel using
crop residue. Producers of renewable fuel using crop residue must keep
records of all of the following:
(1) The specific crop residue feedstock(s) utilized to produce
renewable fuel for each batch of renewable fuel produced.
(2) The total quantity of each specific crop residue feedstock used
for each batch.
(3) Total amount of fuel produced under the crop residue pathway for
each batch.
(o) Requirements for parties that redesignate certified NTDF as
MVNRLM diesel fuel. Parties that redesignate certified NTDF as MVNRLM
diesel fuel under Sec. 80.1408 must keep all of the following
additional records:
(1) Records related to all transactions in which certified NTDF is
redesignated as MVNRLM diesel fuel.
(2) Records related to all transactions in which MVNRLM diesel fuel
is redesignated to a non-transportation use.
[[Page 227]]
(3) Records related to the volume of MVNRLM diesel fuel received.
(4) Records related to the volume of MVNRLM diesel fuel delivered.
(5) Records related to the volume of certified NTDF received.
(6) Records related to the volume of certified NTDF delivered.
(p) Requirements for recordkeeping of RIN holdings for all parties
transacting or owning RINs. (1) Starting January 1, 2020, parties must
retain records related to end-of-day separated D6 RIN holdings, and any
associated calculations recorded in order to meet the RIN holdings
requirements described in Sec. 80.1435 for a period of at least five
years. Such records must include information related to any corporate
affiliates, contractual affiliates, and their RIN holdings and
calculations.
(2) Parties must retain records related to their reports to EPA
regarding threshold compliance under Sec. Sec. 80.1435 and 80.1451 for
a period of at least five years.
(q) Requirements for recordkeeping of contractual and corporate
affiliates. (1) Parties must retain records including, but not limited
to, the name, address, business location, contact information, and
description of relationship, for each RIN-holding corporate affiliate
for a period of at least five years. For the corporate affiliate group,
a relational diagram.
(2) Parties must retain records including, but not limited to, the
name, address, business location, contact information, and contract or
other agreement for each contractual affiliate for a period of at least
five years.
(3) If a party claims an exemption from aggregation under Sec.
80.1435(e), the party must retain all records in support of the
exemption for a period of at least five years and must provide these
records to the attest auditor under Sec. 80.1464, and to EPA upon
request.
(r) Transaction requirement. Beginning July 1, 2010, all parties
must keep transaction information sent to EMTS in addition to other
records required under this section.
(1) For buy or sell transactions of separated RINs, parties must
retain records substantiating the price reported to EPA under Sec.
80.1452.
(2) For buy or sell transactions of separated RINs on or after
January 1, 2020, parties must retain records demonstrating the
transaction mechanism (e.g., spot market or fulfilling a term contract).
(s) Record retention requirement. (1) The records required under
paragraphs (a) through (d), (f) through (l), (n), and (r) of this
section and under Sec. 80.1453 must be kept for five years from the
date they were created, except that records related to transactions
involving RINs must be kept for five years from the date of the RIN
transaction.
(2) The records required under paragraph (e) of this section must be
kept through calendar year 2022.
(t) Record availability requirement. On request by the EPA, the
records required under this section and under Sec. 80.1453 must be made
available to EPA. For records that are electronically generated or
maintained, the equipment or software necessary to read the records
shall be made available; or, if requested by the EPA, electronic records
shall be converted to paper documents.
(u) Record transfer requirement. The records required in paragraphs
(b)(3) and (c)(1) of this section must be transferred with any renewable
fuel sent to the importer of that renewable fuel by any non-RIN-
generating foreign producer.
(v) English language records. Any document requested by EPA under
this section must be submitted in English or must include an English
translation.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26046, May 10, 2010; 75
FR 76829, Dec. 9, 2010; 75 FR 79978, Dec. 21, 2010; 77 FR 74606, Dec.
17, 2012; 78 FR 22789, Apr. 17, 2013; 78 FR 41715, July 11, 2013; 78 FR
62471, Oct. 22, 2013; 79 FR 42118, 42165, July 18, 2014; 84 FR 27024,
June 10, 2019; 85 FR 7080, Feb. 6, 2020; 85 FR 78467, Dec. 4, 2020; 87
FR 39670, July 1, 2022; 87 FR 54166, Sept. 2, 2022; 88 FR 44589, July
12, 2023]
Sec. 80.1455 [Reserved]
Sec. 80.1456 What are the provisions for cellulosic biofuel waiver
credits?
(a) If EPA reduces the applicable volume of cellulosic biofuel
pursuant to section 211(o)(7)(D)(i) of the Clean Air Act (42 U.S.C.
7545(o)(7)(D)(i)) for any given compliance year, then EPA will
[[Page 228]]
provide cellulosic biofuel waiver credits for purchase for that
compliance year.
(1) The price of these cellulosic biofuel waiver credits will be set
by EPA on an annual basis in accordance with paragraph (d) of this
section.
(2) The total cellulosic biofuel waiver credits available will be
equal to the reduced cellulosic biofuel volume established by EPA for
the compliance year.
(b) Use of cellulosic biofuel waiver credits. (1) Cellulosic biofuel
waiver credits are only valid for use in the compliance year that they
are made available.
(2) Cellulosic biofuel waiver credits are nonrefundable.
(3) Cellulosic biofuel waiver credits are nontransferable.
(4) Cellulosic biofuel waiver credits may only be used for an
obligated party's current year cellulosic biofuel RVO and not towards
any prior year deficit cellulosic biofuel volume obligations.
(c) Purchase of cellulosic biofuel waiver credits. (1) Only parties
with an RVO for cellulosic biofuel may purchase cellulosic biofuel
waiver credits.
(2) Cellulosic biofuel waiver credits shall be purchased from EPA at
the time that a party submits its annual compliance report to EPA
pursuant to Sec. 80.1451(a)(1).
(3) Parties may not purchase more cellulosic biofuel waiver credits
than their current year cellulosic biofuel RVO minus cellulosic biofuel
RINs with a D code of 3 that they own.
(4) Cellulosic biofuel waiver credits may only be used to meet an
obligated party's cellulosic biofuel RVO.
(d) Setting the price of cellulosic biofuel waiver credits. (1) The
price for cellulosic biofuel waiver credits shall be set equal to the
greater of:
(i) $0.25 per cellulosic biofuel waiver credit, adjusted for
inflation in comparison to calendar year 2008; or
(ii) $3.00 less the wholesale price of gasoline per cellulosic
biofuel waiver credit, adjusted for inflation in comparison to calendar
year 2008.
(2) The wholesale price of gasoline will be calculated by averaging
the most recent twelve monthly values for U.S. Total Gasoline Bulk Sales
(Price) by Refiners as provided by the Energy Information Administration
that are available as of September 30 of the year preceding the
compliance period.
(3) The inflation adjustment will be calculated by comparing the
Consumer Price Index for All Urban Consumers (CPI-U): U.S. City Average,
Unadjusted Index for All Items expenditure category as provided by the
Bureau of Labor Statistics for June of the year preceding the compliance
period to the comparable value reported for January 2009.
(e) Cellulosic biofuel waiver credits under this section will only
be able to be purchased on forms and following procedures prescribed by
EPA.
[75 FR 14863, Mar. 26, 2010, as amended at 80 FR 18141, Apr. 3, 2015]
Sec. 80.1457 Petition process for aggregate compliance approach for
foreign countries.
(a) EPA may approve a petition for application of the aggregate
compliance approach to planted crops and crop residue from existing
agricultural land in a foreign country if EPA determines that an
aggregate compliance approach will provide reasonable assurance that
planted crops and crop residue from the country in question meet the
definition of renewable biomass and will continue to meet the definition
of renewable biomass, based on the submission of credible, reliable, and
verifiable data.
(1) As part of its evaluation, EPA will consider all of the
following:
(i) Whether there has been a reasonable identification of the ``2007
baseline area of land,'' defined as the total amount of cropland,
pastureland, and land that is equivalent to U.S. Conservation Reserve
Program land in the country in question that was actively managed or
fallow and nonforested on December 19, 2007.
(ii) Whether information on the total amount of cropland,
pastureland, and land that is equivalent to U.S. Conservation Reserve
Program land in the country in question for years preceding and
following calendar year 2007 shows that the 2007 baseline area of land
identified in paragraph (a)(1)(i) of this section is not likely to be
exceeded in the future.
[[Page 229]]
(iii) Whether economic considerations, legal constraints, historical
land use and agricultural practices and other factors show that it is
likely that producers of planted crops and crop residue will continue to
use agricultural land within the 2007 baseline area of land identified
in paragraph (a)(1)(i) of this section into the future, as opposed to
clearing and cultivating land not included in the 2007 baseline area of
land.
(iv) Whether there is a reliable method to evaluate on an annual
basis whether the 2007 baseline area of land identified in paragraph
(a)(1)(i) of this section is being or has been exceeded.
(v) Whether a credible and reliable entity has been identified to
conduct data gathering and analysis, including annual identification of
the aggregate amount of cropland, pastureland, and land that is
equivalent to U.S. Conservation Reserve Program land, needed for the
annual EPA evaluation specified in Sec. 80.1454(g)(1), and whether the
data, analyses, and methodologies are publicly available.
(2) [Reserved]
(b) Any petition and all supporting materials submitted under
paragraph (a) of this section must be submitted both in English and its
original language (if other than English), and must include all of the
following or an explanation of why it is not needed for EPA to consider
the petition:
(1) Maps or electronic data identifying the boundaries of the land
for which the petitioner seeks approval of an aggregate compliance
approach.
(2) The total amount of land that is cropland, pastureland, or land
equivalent to U.S. Conservation Reserve Program land within the
geographic boundaries specified in paragraph (b)(1) of this section that
was cleared or cultivated prior to December 19, 2007 and that was
actively managed or fallow and nonforested on that date, and
(3) Land use data that demonstrates that the land identified in
paragraph (b)(1) of this section is cropland, pastureland or land
equivalent to U.S. Conservation Reserve Program land that was cleared or
cultivated prior to December 19, 2007, and that was actively managed or
fallow and nonforested on that date, which may include any of the
following:
(i) Satellite imagery or data.
(ii) Aerial photography.
(iii) Census data.
(iv) Agricultural survey data.
(v) Agricultural economic modeling data.
(4) Historical land use data for the land within the geographic
boundaries specified in paragraph (b)(1) of this section to the current
year, which may include any of the following:
(i) Satellite imagery or data.
(ii) Aerial photography.
(iii) Census data.
(iv) Agricultural surveys.
(v) Agricultural economic modeling data.
(5) A description of any applicable laws, agricultural practices,
economic considerations, or other relevant factors that had or may have
an effect on the use of agricultural land within the geographic
boundaries specified in paragraph (b)(1) of this section, including
information regarding the efficacy and enforcement of relevant laws and
regulations.
(6) A plan describing how the petitioner will identify a credible
and reliable entity who will, on a continuing basis, conduct data
gathering, analysis, and submittal to assist EPA in making an annual
determination of whether the criteria specified in paragraph (a) of this
section remains satisfied.
(7) A letter, signed by a national government representative at the
ministerial level or equivalent, confirming that the petition and all
supporting data have been reviewed and verified by the ministry (or
ministries) or department(s) of the national government with primary
expertise in agricultural land use patterns, practices, data, and
statistics, that the data support a finding that planted crops and crop
residue from the specified country meet the definition of renewable
biomass and will continue to meet the definition of renewable biomass,
and that the responsible national government ministry (or ministries) or
department(s) will review and verify the data submitted on an annual
basis to facilitate EPA's annual evaluation of the 2007 baseline area of
land specified in
[[Page 230]]
Sec. 80.1454(g)(1) for the country in question.
(8) Any additional information that EPA may require.
(c) EPA will issue a Federal Register notice informing the public of
receipt of any petition submitted pursuant to this section and will
provide a 60-day period for public comment. If EPA approves a petition
it will issue a Federal Register notice announcing its decision and
specifying an effective date for the application of the aggregate
compliance approach to planted crops and crop residue from the country.
Thereafter, the planted crops and crop residue from the country will be
covered by the aggregate compliance approach set forth in Sec.
80.1454(g), or as otherwise specified pursuant to paragraph (d) of this
section.
(d) If EPA grants a petition to establish an aggregate compliance
approach for planted crops and crop residue from a foreign country, it
may include any conditions that EPA considers appropriate in light of
the conditions and circumstances involved.
(e)(1) EPA may withdraw its approval of the aggregate compliance
approach for the planted crops and crop residue from the country in
question if:
(i) EPA determines that the data submitted pursuant to the plan
described in paragraph (b)(6) of this section does not demonstrate that
the amount of cropland, pastureland and land equivalent to U.S.
Conservation Reserve Program land within the geographic boundaries
covered by the approved petition does not exceed the 2007 baseline area
of land;
(ii) EPA determines based on other information that the criteria
specified in paragraph (a) of this section is no longer satisfied; or
(iii) EPA determines that the data needed for its annual evaluation
has not been collected and submitted in a timely and appropriate manner.
(2) If EPA withdraws its approval for a given country, then
producers using planted crops or crop residue from that country will be
subject to the individual recordkeeping and reporting requirements of
Sec. 80.1454(b) through (d) in accordance with the schedule specified
in Sec. 80.1454(g).
[75 FR 76829, Dec. 9, 2010, as amended at 88 FR 44590, July 12, 2023]
Sec. 80.1458 Storage of renewable fuel, RNG, or biointermediate prior
to registration.
(a) Applicability. (1) A renewable fuel producer may store renewable
fuel for the generation of RINs prior to EPA acceptance of their
registration under Sec. 80.1450(b) if all the requirements of this
section are met.
(2) An RNG producer may store RNG prior to EPA acceptance of their
registration under Sec. 80.135 if all the requirements of this section
are met.
(3) A biointermediate producer may store biointermediate (including
biogas used to produce a biogas-derived renewable fuel) prior to EPA
acceptance of their registration under Sec. 80.1450(b) if all the
requirements of this section are met.
(b) Storage requirements. In order for a renewable fuel, RNG, or
biointermediate producer to store renewable fuel, RNG, or
biointermediate under this section, the producer must do the following:
(1) Produce the stored renewable fuel, RNG, or biointermediate after
an independent third-party engineer has conducted an engineering review
for the renewable fuel, RNG, or biointermediate production facility
under Sec. 80.1450(b)(2).
(2) Produce the stored renewable fuel, RNG, or biointermediate in
accordance with all applicable requirements under this part.
(3) Make no change to the facility after the independent third-party
engineer completed the engineering review.
(4) Store the renewable fuel, RNG, or biointermediate at the
facility that produced the renewable fuel, RNG, or biointermediate.
(5) Maintain custody and title to the stored renewable fuel, RNG, or
biointermediate until EPA accepts the producer's registration under
Sec. 80.1450(b).
(c) RIN generation. (1) A RIN generator may only generate RINs for
stored
[[Page 231]]
renewable fuel, stored RNG, or renewable fuel produced from stored
biointermediate if the RIN generator generates the RINs under Sec. Sec.
80.125, 80.1426, and 80.1452, as applicable, after EPA accepts their
registration under Sec. 80.1450(b) and meets all other applicable
requirements under this part for RIN generation.
(2) The RIN year of any RINs generated for stored renewable fuel,
stored RNG, or renewable fuel produced from stored biointermediate is
the year that the renewable fuel or RNG was produced.
(d) Limitations. RNG injected into a natural gas commercial pipeline
system prior to EPA acceptance of a renewable fuel producer's
registration under Sec. 80.135 does not meet the requirements of this
section and may not be stored.
[88 FR 44590, July 12, 2023]
Sec. 80.1459 [Reserved]
Sec. 80.1460 What acts are prohibited under the RFS program?
(a) Renewable fuels producer or importer violation. No person shall
produce or import a renewable fuel without complying with the
requirements of Sec. 80.1426 regarding the generation and assignment of
RINs.
(b) RIN generation and transfer violations. No person shall do any
of the following:
(1) Generate a RIN for a fuel that is not a renewable fuel, or for
which the applicable renewable fuel volume was not produced.
(2) Create or transfer to any person a RIN that is invalid under
Sec. 80.1431.
(3) Transfer to any person a RIN that is not properly identified as
required under Sec. 80.1425.
(4) Transfer to any person a RIN with a K code of 1 without
transferring an appropriate volume of renewable fuel to the same person
on the same day.
(5) Introduce into commerce any renewable fuel produced from a
feedstock, biointermediate, or through a process that is not described
in the person's registration information.
(6) Generate a RIN for fuel for which RINs have previously been
generated unless the RINs were generated under Sec. 80.1426(c)(6).
(7) Generate a RIN for fuel that fails to meet all the conditions
set forth in an approval document for a pathway petition submitted under
Sec. 80.1416.
(8) Generate a RIN for fuel that was produced from a biointermediate
for which the fuel and biointermediate were not audited under an EPA-
approved quality assurance plan.
(c) RIN use violations. No person shall do any of the following:
(1) Fail to acquire sufficient RINs, or use invalid RINs, to meet
the person's RVOs under Sec. 80.1427.
(2) Use a validly generated RIN to meet the person's RVOs under
Sec. 80.1427, or separate and transfer a validly generated RIN, where
the person using the RIN ultimately uses the renewable fuel volume
associated with the RIN in an application other than for use as
transportation fuel, jet fuel, or heating oil.
(3) Use a validly generated RIN to meet the person's RVOs under
Sec. 80.1427, or separate and transfer a validly generated RIN, where
the person ultimately uses the renewable fuel volume associated with the
RIN in an application other than for use as transportation fuel, jet
fuel, or heating oil.
(d) RIN retention violation. No person shall retain RINs in
violation of the requirements in Sec. 80.1428(a)(4).
(e) Causing a violation. No person shall cause another person to
commit an act in violation of any prohibited act under this section.
(f) Failure to meet a requirement. No person shall fail to meet any
requirement that applies to that person under this subpart.
(g) Failing to use a renewable fuel oil for its intended use. No
person shall use fuel oil that meets paragraph (2) of the definition of
``heating oil'' in Sec. 80.2 and for which RINs have been generated in
an application other than to heat or cool interior spaces of homes or
buildings to control ambient climate for human comfort.
(h) RIN separation violations. No person shall do any of the
following:
(1) Identify separated RINs in EMTS with the wrong separation reason
code.
(2) Identify separated RINs in EMTS without having a qualifying
separation event pursuant to Sec. 80.1429.
(3) Separate more than 2.5 RINs per gallon of renewable fuel that
has a
[[Page 232]]
valid qualifying separation event pursuant to Sec. 80.1429.
(4) Separate RINs outside of the requirements in Sec. 80.1452(c).
(5) Improperly separate RINs in any other way not listed in
paragraphs (h)(1)-(4) of this section.
(i) Independent third-party auditor violations. No person shall do
any of the following:
(1) Fail to fully implement a QAP approved under Sec. 80.1469.
(2) Fail to fully, accurately, and timely notify all appropriate
parties of potentially invalid RINs under Sec. 80.1474(b).
(3) Verify a RIN under Sec. 80.1471(e) without verifying every
applicable requirement in Sec. 80.1469 and verifying each element in an
approved QAP.
(j) Redesignation violations. No person may exceed the balance
requirements at Sec. 80.1408(a)(2)(i) without incurring an RVO.
(k) Biointermediate-related violations. No person may do any of the
following:
(1) Introduce into commerce for use in the production of a renewable
fuel any biointermediate produced from a feedstock or through a process
that is not described in the person's registration information.
(2) Produce a renewable fuel at more than one facility unless the
person uses a biointermediate or the renewable biomass is not
substantially altered. Form changes of renewable biomass such as
bleaching through adsorption, rendering fats, chopping, crushing,
grinding, pelletizing, filtering, compacting/compression, centrifuging,
degumming, dewatering/drying, melting, triglycerides resulting from
deodorizing, or the addition of water to produce a slurry do not
constitute substantial alteration.
(3) Transfer a biointermediate from a biointermediate production
facility to a facility other than the renewable fuel production facility
specified in the biointermediate producer's registration under Sec.
80.1450(b)(1)(ii)(B)(1).
(4) Isolate or concentrate non-characteristic components of the
feedstock to yield a biointermediate not identified in a registration
accepted by EPA.
(5) No person may transfer a biointermediate without complying with
the PTD requirements in Sec. 80.1453(f).
(l) Independent third-party engineer violations. No person shall do
any of the following:
(1) Fail to identify any incorrect information submitted by any
party as specified in Sec. 80.1450(b)(2).
(2) Fail to meet any requirement related to engineering reviews as
specified in Sec. 80.1450(b)(2).
(3) Fail to disclose to EPA any financial, professional, business,
or other interests with parties for whom the independent third-party
engineer provides services under Sec. 80.1450.
(4) Fail to meet any requirement related to the independent third-
party engineering review requirements in Sec. 80.1450(b)(2) or (d)(1).
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26047, May 10, 2010; 77
FR 1357, Jan. 9, 2012; 78 FR 62471, Oct. 22, 2013; 79 FR 42119, July 18,
2014; 85 FR 7080, Feb. 6, 2020; 87 FR 39671, July 1, 2022; 88 FR 44591,
July 12, 2023]
Sec. 80.1461 Who is liable for violations under the RFS program?
(a) Liability for violations of prohibited acts. (1) Any person who
violates a prohibition under Sec. 80.1460(a) through (d) or (g) through
(k) is liable for the violation of that prohibition.
(2) Any person who causes another person to violate a prohibition
under Sec. 80.1460(a) through (d) or (g) through (k) is liable for a
violation of Sec. 80.1460(e).
(b) Liability for failure to meet other provisions of this subpart.
(1) Any person who fails to meet a requirement of any provision of this
subpart is liable for a violation of that provision.
(2) Any person who causes another person to fail to meet a
requirement of any provision of this subpart is liable for causing a
violation of that provision.
(c) Parent corporation liability. Any parent corporation is liable
for any violation of this subpart that is committed by any of its
subsidiaries.
(d) Joint venture liability. Each partner to a joint venture is
jointly and severally liable for any violation of this subpart that is
committed by the joint venture operation.
(e) Biointermediate liability. When a biointermediate contained in
any storage tank at any facility owned, leased, operated, controlled, or
supervised by
[[Page 233]]
any biointermediate producer, biointermediate importer, renewable fuel
producer, or foreign ethanol producer is found in violation of a
prohibition described in Sec. 80.1460(k)(1) and (3), the following
persons shall be deemed in violation:
(1) Each biointermediate producer, biointermediate importer,
renewable fuel producer, renewable fuel importer, or foreign ethanol
producer who owns, leases, operates, controls, or supervises the
facility where the violation is found.
(2) Each biointermediate producer, biointermediate importer,
renewable fuel producer, renewable fuel importer, or foreign ethanol
producer who manufactured, imported, sold, offered for sale, dispensed,
offered for supply, stored, transported, or caused the transportation of
any biointermediate that is in the storage tank containing the
biointermediate found to be in violation.
(3) Each carrier who dispensed, supplied, stored, or transported any
biointermediate that was in the storage tank containing the
biointermediate found to be in violation, provided that EPA
demonstrates, by reasonably specific showings using direct or
circumstantial evidence, that the carrier caused the violation.
(f) Third-party liability. Any party allowed under this subpart to
conduct sampling and testing on behalf of a regulated party and does so
to demonstrate compliance with the requirements of this subpart must
meet those requirements in the same way that the regulated party must
meet those requirements. The regulated party and the third party are
both liable for any violations arising from the third party's failure to
meet the requirements of this subpart.
[75 FR 14863, Mar. 26, 2010, as amended at 79 FR 42119, July 18, 2014;
85 FR 7080, Feb. 6, 2020; 87 FR 39671, July 1, 2022; 88 FR 44591, July
12, 2023]
Sec. 80.1462 [Reserved]
Sec. 80.1463 What penalties apply under the RFS program?
(a) Any person who is liable for a violation under Sec. 80.1461 is
subject to a civil penalty as specified in sections 205 and 211(d) of
the Clean Air Act, for every day of each such violation and the amount
of economic benefit or savings resulting from each violation.
(b) Any person liable under Sec. 80.1461(a) for a violation of
Sec. 80.1460(c) for failure to meet its RVOs, or Sec. 80.1460(e) for
causing another person to fail to meet their RVOs during any compliance
period, is subject to a separate day of violation for each day in the
compliance period.
(c) Any person liable under Sec. 80.1461(b) for failure to meet, or
causing a failure to meet, a requirement of any provision of this
subpart is liable for a separate day of violation for each day such a
requirement remains unfulfilled.
(d) Any person liable under Sec. 80.1461(a) for a violation of
Sec. 80.1460(b)(1) through (4) or (6) through (8) is subject to a
separate day of violation for each day that an invalid RIN remains
available for an obligated party or exporter of renewable fuel to
demonstrate compliance with the RFS program.
[75 FR 14863, Mar. 26, 2010, as amended at 75 FR 26047, May 10, 2010; 79
FR 42165, July 18, 2014; 85 FR 7080, Feb. 6, 2020; 87 FR 39671, July 1,
2022]
Sec. 80.1464 What are the attest engagement requirements under the RFS
program?
The requirements regarding annual attest engagements in 40 CFR
1090.1800, also apply to any attest engagement procedures required under
this subpart M. In addition to any other applicable attest engagement
procedures, such as the requirements in Sec. 80.1466, the following
annual attest engagement procedures are required under this subpart.
(a) Obligated parties and exporters of renewable fuel. The following
attest procedures shall be completed for any obligated party or exporter
of renewable fuel:
(1) Annual compliance demonstration report. (i) Obtain and read a
copy of the annual compliance demonstration report required under Sec.
80.1451(a)(1) which contains information regarding all the following:
(A) The obligated party's volume of all products listed in Sec.
80.1407(c) and (e),
[[Page 234]]
or the exporter of renewable fuel's volume of each category of exported
renewable fuel identified in Sec. 80.1430(b)(1) through (b)(4).
(B) RVOs.
(C) RINs used for compliance.
(ii) Obtain documentation of any volumes of renewable fuel used in
products listed in Sec. 80.1407(c) and (e) at the refinery or import
facility or exported during the reporting year; compute and report as a
finding the total volumes of renewable fuel represented in these
documents.
(iii) For obligated parties, compare the volumes of products listed
in Sec. 80.1407(c), (e), and (f) reported to EPA in the report required
under Sec. 80.1451(a)(1) with the volumes, excluding any renewable fuel
volumes, contained in the inventory reconciliation analysis under 40 CFR
1090.1810 and the volume of non-renewable diesel produced or imported.
Verify that the volumes reported to EPA agree with the volumes in the
inventory reconciliation analysis and the volumes of non-renewable
diesel produced or imported, and report as a finding any exception.
(iv) For exporters of renewable fuel, perform all of the following:
(A) Obtain the database, spreadsheet, or other documentation that
the exporter of renewable fuel maintains for all exported renewable
fuel.
(B) Compare the volume of products identified in these documents
with the volumes reported to EPA.
(C) Verify that the volumes reported to EPA agree with the volumes
identified in the database, spreadsheet, or other documentation, and
report as a finding any exception.
(D) Select sample batches in accordance with the guidelines in 40
CFR 1090.1805 from each separate category of renewable fuel exported and
identified in Sec. 80.1451(a); obtain invoices, bills of lading and
other documentation for the representative samples; state whether any of
these documents refer to the exported fuel as advanced biofuel or
cellulosic biofuel; and report as a finding whether or not the exporter
of renewable fuel calculated an advanced biofuel or cellulosic biofuel
RVO for these fuels pursuant to Sec. 80.1430(b)(1) or (3).
(v) Compute and report as a finding the RVOs for the obligated party
or exporter of renewable fuel, and any deficit RVOs carried over from
the previous year or carried into the subsequent year, and verify that
the values agree with the values reported to EPA.
(vi) Obtain the database, spreadsheet, or other documentation for
all RINs by type of renewable fuel used for compliance during the year
being reviewed; calculate the total number of RINs associated with each
type of renewable fuel used for compliance by year of generation
represented in these documents; state whether this information agrees
with the report to EPA and report as a finding any exceptions.
(vii) For obligated parties that redesignate certified NTDF as
MVNRLM diesel fuel under Sec. 80.1408, perform the additional attest
engagement procedures described at Sec. 80.1475 and report any findings
in the report described in paragraph (d) of this section. Parties that
do not incur an RVO under Sec. 80.1408(a)(2)(i) and do not otherwise
need to complete an attest engagement under this paragraph (a) do not
need to arrange for the additional attest engagement procedures under
Sec. 80.1475 to be performed.
(2) RIN transaction reports and product transfer documents. (i)
Obtain and read copies of a representative sample, selected in
accordance with the guidelines in 40 CFR 1090.1805, of each RIN
transaction type (RINs purchased, RINs sold, RINs retired, RINs
separated, RINs reinstated) included in the RIN transaction reports
required under Sec. 80.1451(a)(2) for the compliance year.
(ii) Obtain contracts, invoices, or other documentation for the
representative samples of RIN transactions; compute the transaction
types, transaction dates, and RINs traded; state whether the information
agrees with the party's reports to EPA and report as a finding any
exceptions.
(iii) Verify that the product transfer documents for the
representative samples under paragraph (a)(2)(i) of this section of RINs
sold and the RINs purchased contain the applicable information required
under Sec. 80.1453 and report as a finding any product transfer
document that does not contain the required information.
[[Page 235]]
(iv) Verify the accuracy of the information contained in the product
transfer documents reviewed pursuant to paragraph (a)(2)(iii) of this
section and report as a finding any exceptions.
(3) RIN activity reports. (i) Obtain and read copies of all
quarterly RIN activity reports required under Sec. 80.1451(a)(3) for
the compliance year.
(ii) Obtain the database, spreadsheet, or other documentation used
to generate the information in the RIN activity reports; compare the RIN
transaction samples reviewed under paragraph (a)(2) of this section with
the corresponding entries in the database or spreadsheet and report as a
finding any discrepancies; compute the total number of current-year and
prior-year RINs owned at the start and end of each quarter, and for
parties that reported RIN activity for RINs assigned to a volume of
renewable fuel, the volume and type of renewable fuel owned at the end
of each quarter, as represented in these documents; and state whether
this information agrees with the party's reports to EPA.
(4) RIN holdings. (i) Obtain and read copies of the RIN holdings
calculations performed under Sec. 80.1435 for the party and any
corporate affiliates and the applicable database, spreadsheet, or other
documentation the party maintains.
(ii) Select sample calculations in accordance with the guidelines in
40 CFR 1090.1805; compute and report as a finding the results of these
calculations and verify that the results agree with the values reported
to EPA.
(iii) Identify any date(s) where the aggregated calculation exceeded
the RIN holding threshold(s) specified in Sec. 80.1435. Compute and
state as a finding whether this information agrees with the party's
reports (notification of threshold exceedance) to EPA.
(5) Affiliates. Review reports and records related to corporate and
contractual affiliates and state whether this information agrees with
the party's reports to EPA, and report as a finding any exceptions.
(6) Exemption. Review and confirm the existence of records
supporting an exemption from aggregation claimed by the party under
Sec. 80.1435(e), and report as a finding any exceptions.
(7) Compliance reports. Compare the list of compliance reports
submitted to EPA during the compliance period to the reporting
requirements for the entity in Sec. 80.1451. Report as a finding any
reporting requirements that were not completed.
(b) Renewable fuel producers and RIN-generating importers. The
following attest procedures shall be completed for any RIN-generating
renewable fuel producer or importer:
(1) RIN generation reports. (i) Obtain and read copies of the
reports required under Sec. 80.1451(b)(1), (e), and (d) for the
compliance year.
(ii) Obtain production data for each renewable fuel batch by type of
renewable fuel that was produced or imported during the year being
reviewed; compute the RIN numbers, production dates, types, volumes of
ethanol denaturant and applicable equivalence values, and production
volumes for each batch; report the total RINs generated during the year
being reviewed; and state whether this information agrees with the
party's reports to EPA. Report as a finding any exceptions.
(iii) Verify that the proper number of RINs were generated and
assigned pursuant to the requirements of Sec. 80.1426 for each batch of
renewable fuel produced or imported. For RINs generated for ethanol
produced from corn starch at a facility using an approved pathway that
requires the use of one or more of the advanced technologies listed in
Table 2 to Sec. 80.1426, verify that the required advanced technology
or technologies were employed in accordance with the specifications in
Tables 1 and 2 to Sec. 80.1426, including any requirement for
application to 90% of the production on a calendar year basis.
(iv) Obtain product transfer documents for a representative sample,
selected in accordance with the guidelines in 40 CFR 1090.1805, of
renewable fuel batches produced or imported during the year being
reviewed; verify that the product transfer documents contain the
applicable information required under Sec. 80.1453; verify the accuracy
of the information contained in the product transfer documents; report
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as a finding any product transfer document that does not contain the
applicable information required under Sec. 80.1453.
(v)(A) Obtain documentation, as required under Sec. 80.1451(b),
(d), and (e), associated with feedstock and biointermediate purchases
for a representative sample of feedstocks and biointermediates
separately, selected in accordance with the guidelines in 40 CFR
1090.1805, of renewable fuel batches produced or imported during the
year being reviewed.
(B) Verify that feedstocks were properly identified in the reports
and met the definition of renewable biomass.
(C) Verify that biointermediates were properly identified in the
reports, as applicable.
(2) RIN transaction reports and product transfer documents. (i)
Obtain and read copies of a representative sample, selected in
accordance with the guidelines in 40 CFR 1090.1805, of each transaction
type (RINs purchased, RINs sold, RINs retired, RINs separated, RINs
reinstated) included in the RIN transaction reports required under Sec.
80.1451(b)(2) for the compliance year.
(ii) Obtain contracts, invoices, or other documentation for the
representative samples of RIN transactions; compute the transaction
types, transaction dates, and the RINs traded; state whether this
information agrees with the party's reports to EPA and report as a
finding any exceptions.
(iii) Verify that the product transfer documents for the
representative samples under paragraph (b)(2)(i) of this section of RINs
sold and the RINs purchased contain the applicable information required
under Sec. 80.1453 and report as a finding any product transfer
document that does not contain the required information.
(iv) Verify the accuracy of the information contained in the product
transfer documents reviewed pursuant to paragraph (b)(2)(iii) of this
section and report as a finding any exceptions.
(3) RIN activity reports. (i) Obtain and read copies of the
quarterly RIN activity reports required under Sec. 80.1451(b)(3) for
the compliance year.
(ii) Obtain the database, spreadsheet, or other documentation used
to generate the information in the RIN activity reports; compare the RIN
transaction samples reviewed under paragraph (b)(2) of this section with
the corresponding entries in the database or spreadsheet and report as a
finding any discrepancies; report the total number of each RIN generated
during each quarter and compute and report the total number of current-
year and prior-year RINs owned at the start and end of each quarter, and
for parties that reported RIN activity for RINs assigned to a volume of
renewable fuel, the volume of renewable fuel owned at the end of each
quarter, as represented in these documents; and state whether this
information agrees with the party's reports to EPA.
(4) Independent Third Party Engineering Review. (i) Obtain
documentation of independent third-party engineering reviews required
under Sec. 80.1450(b)(2). Such documentation must include the date of
the last engineering review along with date of the actual site visit by
the professional engineer.
(ii) Review and verify the written verification and records
generated as part of the independent third party engineering review.
(iii) Verify that independent third-party engineering reviews
conducted under Sec. 80.1450(d)(3) occurred within the three-year
cycle. Report as a finding if the engineering review was not updated as
part of the three-year cycle under Sec. 80.1450(d)(3).
(5) RIN holdings. (i) Obtain and read copies of the RIN holdings
calculations performed under Sec. 80.1435 for the party and any
corporate affiliates and the applicable database, spreadsheet, or other
documentation the party maintains.
(ii) Select sample calculations in accordance with the guidelines in
40 CFR 1090.1805; compute and report as a finding the results of these
calculations and verify that the results agree with the values reported
to EPA.
(iii) Identify any date(s) where the aggregated calculation exceeded
the RIN holding threshold(s) specified in Sec. 80.1435. Compute and
state as a finding whether this information agrees with the party's
reports (notification of threshold exceedance) to EPA.
(6) Affiliates. Review reports and records related to corporate and
contractual affiliates and state whether
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this information agrees with the party's reports to EPA, and report as a
finding any exceptions.
(7) Exemption. Review and confirm the existence of records
supporting an exemption from aggregation claimed by the party under
Sec. 80.1435(e), and report as a finding any exceptions.
(8) Compliance reports. Compare the list of compliance reports
submitted to EPA during the compliance period to the reporting
requirements for the entity in Sec. 80.1451. Report as a finding any
reporting requirements that were not completed.
(c) Other parties owning RINs. Except as specified in paragraph
(c)(6) of this section, the following attest procedures must be
completed for any party other than an obligated party or renewable fuel
producer or importer that owns any RINs during a calendar year:
(1) RIN transaction reports and product transfer documents.
(i) Obtain and read copies of a representative sample, selected in
accordance with the guidelines in 40 CFR 1090.1805, of each RIN
transaction type (RINs purchased, RINs sold, RINs retired, RINs
separated, RINs reinstated) included in the RIN transaction reports
required under Sec. 80.1451(c)(1) for the compliance year.
(ii) Obtain contracts, invoices, or other documentation for the
representative samples of RIN transactions; compute the transaction
types, transaction dates, and the RINs traded; state whether this
information agrees with the party's reports to EPA and report as a
finding any exceptions.
(iii) Verify that the product transfer documents for the
representative samples under paragraph (c)(1)(i) of this section of RINs
sold and RINs purchased contain the applicable information required
under Sec. 80.1453 and report as a finding any product transfer
document that does not contain the required information.
(iv) Verify the accuracy of the information contained in the product
transfer documents reviewed pursuant to paragraph (c)(1)(iii) of this
section and report as a finding any exceptions.
(2) RIN activity reports.
(i) Obtain and read copies of the quarterly RIN activity reports
required under Sec. 80.1451(c)(2) for the compliance year.
(ii) Obtain the database, spreadsheet, or other documentation used
to generate the information in the RIN activity reports; compare the RIN
transaction samples reviewed under paragraph (c)(1) of this section with
the corresponding entries in the database or spreadsheet and report as a
finding any discrepancies; compute the total number of current-year and
prior-year RINs owned at the start and end of each quarter, and for
parties that reported RIN activity for RINs assigned to a volume of
renewable fuel, the volume of renewable fuel owned at the end of each
quarter, as represented in these documents; and state whether this
information agrees with the party's reports to EPA.
(3) RIN holdings. (i) Obtain and read copies of the RIN holdings
calculations performed under Sec. 80.1435 for the party and any
corporate affiliates and the applicable database, spreadsheet, or other
documentation the party maintains.
(ii) Select sample calculations in accordance with the guidelines in
40 CFR 1090.1805; compute and report as a finding the results of these
calculations and verify that the results agree with the values reported
to EPA.
(iii) Identify any date(s) where the aggregated calculation exceeded
the RIN holding threshold(s) specified in Sec. 80.1435. Compute and
state as a finding whether this information agrees with the party's
reports (notification of threshold exceedance) to EPA.
(4) Affiliates. Review reports and records related to corporate and
contractual affiliates and state whether this information agrees with
the party's reports to EPA, and report as a finding any exceptions.
(5) Exemption. Review and confirm the existence of records
supporting an exemption from aggregation claimed by the party under
Sec. 80.1435(e), and report as a finding any exceptions.
(6) Low-volume RIN owner exemption. Any party who meets all the
following criteria in a given compliance period is not required to
submit an attest engagement for that compliance period:
(i) The party must be solely registered as a party owning RINs
(i.e., a ``RIN Owner Only'') and must not also
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be registered in any other role under Sec. 80.1450 (e.g., the party
must not also be an obligated party, exporter of renewable fuel,
renewable fuel producer, RIN generating importer, etc.).
(ii) The party must have transacted (e.g., generated, bought, sold,
separated, or retired) 10,000 or fewer RINs in the given compliance
period.
(iii) The party has not exceeded the RIN holding threshold(s)
specified in Sec. 80.1435.
(7) Compliance reports. Compare the list of compliance reports
submitted to EPA during the compliance period to the reporting
requirements for the entity in Sec. 80.1451. Report as a finding any
reporting requirements that were not completed.
(d) Report submission deadlines--(1) Obligated parties. (i) Except
as specified in paragraph (d)(1)(ii) of this section, for obligated
parties, annual attest engagement reports must be submitted to EPA by
whichever of the following dates is latest:
(A) June 1 of the subsequent calendar year.
(B) The next June 1 annual attest engagement reporting deadline
after the annual compliance reporting deadline under Sec.
80.1451(f)(1)(i)(A).
(ii)(A) For obligated parties that meet the requirements for a small
refinery under Sec. 80.1441(e)(2)(iii), for the 2019 compliance year,
annual attest engagement reports must be submitted to EPA no later than
the next June 1 annual attest engagement reporting deadline after the
annual compliance reporting deadline under Sec. 80.1451(f)(1)(i)(B)(1).
(B) For obligated parties, for the 2020 compliance year, annual
attest engagement reports must be submitted to EPA no later than the
next June 1 annual attest engagement reporting deadline after the annual
compliance reporting deadline under Sec. 80.1451(f)(1)(i)(B)(2).
(C) For obligated parties, for the 2021 compliance year, annual
attest engagement reports must be submitted to EPA no later than the
next June 1 annual attest engagement reporting deadline after the annual
compliance reporting deadline under Sec. 80.1451(f)(1)(i)(B)(3).
(D) For obligated parties, for the 2022 compliance year, annual
attest engagement reports must be submitted to EPA no later than the
next June 1 annual attest engagement reporting deadline after the annual
compliance reporting deadline under Sec. 80.1451(f)(1)(i)(B)(4).
(2) All other parties. All parties other than obligated parties must
submit annual attest engagement reports to EPA by June 1 of the
subsequent calendar year.
(3) Deadline publication. The annual attest engagement reporting
deadline will be calculated in accordance with paragraph (d)(1) of this
section and published on EPA's website.
(e) The party conducting the procedures under this section shall
obtain a written representation from a company representative that the
copies of the reports required under this section are complete and
accurate copies of the reports filed with EPA.
(f) The party conducting the procedures under this section shall
identify and report as a finding the commercial computer program used by
the party to track the data required by the regulations in this subpart,
if any.
(g) [Reserved]
(h) Biointermediate producers. The following attest reports must be
completed for any biointermediate producer that produces a
biointermediate in a compliance year:
(1) Biointermediate production reports. (i) Obtain and read copies
of the quarterly biointermediate production reports required under Sec.
80.1451(i); compare the reported information to the requirements under
Sec. 80.1451(i); and report as a finding any missing or incomplete
information in the reports.
(ii) Obtain any database, spreadsheet, or other documentation used
to generate the information in the biointermediate production reports;
compare the corresponding entries in the database or spreadsheet and
report as a finding any discrepancies.
(iii) For a representative sample of biointermediate batches,
selected in accordance with the guidelines in 40 CFR 1090.1805, obtain
records required under Sec. 80.1454(i); compare these records to the
corresponding batch entries in the reports procured in paragraph
[[Page 239]]
(h)(1)(i) of this section and report as a finding any discrepancies.
(iv) Obtain the list of designated renewable fuel production
facilities under Sec. 80.1450(b)(1)(ii)(B)(1); compare the list of
registered designated renewable fuel production facilities to those
identified in the biointermediate production report; and report as a
finding any discrepancies.
(v) Provide the list of renewable fuel producers receiving any
transfer of biointermediate batches and calculate the total volume from
the batches received.
(2) Independent third-party engineering review. (i) Obtain
documentation of independent third-party engineering reviews required
under Sec. 80.1450(b)(2).
(ii) Review and verify the written verification and records
generated as part of the independent third-party engineering review.
(iii) Provide the date of the submission of the last engineering
review along with the date of the actual site visit by the professional
engineer. Report as a finding if the engineering review was not updated
as part of the three-year cycle under Sec. 80.1450(d)(3).
(iv) Compare and provide the total volume of produced
biointermediate during the compliance year as compared to the production
capacity stated in the engineering review and report as a finding if the
volume of produced biointermediate is greater than the stated production
capacity.
(3) Product transfer documents. (i) Obtain contracts, invoices, or
other documentation for each batch in the representative sample under
paragraph (h)(1)(iii) of this section and the corresponding copies of
product transfer documents required under Sec. 80.1453; compare the
product transfer documents with the contracts and invoices and report as
a finding any discrepancies.
(ii) Verify that the product transfer documents obtained in
paragraph (h)(3)(i) of this section contain the applicable information
required under Sec. 80.1453 and report as a finding any product
transfer document that does not contain the required information.
(iii) Verify the accuracy of the information contained in the
product transfer documents reviewed pursuant to paragraph (h)(3)(ii) of
this section with the records obtained and reviewed under paragraph
(h)(1)(iii) of this section and report as a finding any exceptions.
(i) Independent third-party auditors. The following attest
procedures shall be completed for any independent third-party auditor
that implements a quality assurance plan in a calendar year:
(1)Comparing verification reports with approved QAPs. (i) Obtain and
read copies of reports required under Sec. 80.1451(g)(1). Compare the
list of compliance reports submitted to EPA during the compliance period
to the reporting requirements for the entity in Sec. 80.1451. Report as
a finding any reporting requirements that were not completed.
(ii) Obtain and read copies of any quality assurance plans approved
under Sec. 80.1469.
(iii) Confirm that the independent third-party auditor only verified
RINs and biointermediates covered by approved QAPs under Sec. 80.1469.
Identify as a finding any discrepancies.
(2) Checking third-party auditor's verification. (i) Obtain and read
copies of reports required under Sec. 80.1451(g)(2). Compare the list
of compliance reports submitted to EPA during the compliance period to
the reporting requirements for the entity in Sec. 80.1451. Report as a
finding any reporting requirements that were not completed.
(ii) Obtain all notifications of potentially invalid RINs and
potentially improperly produced biointermediate submitted to the EPA
under Sec. Sec. 80.1474(b)(3) and 80.1477(d)(2) respectively.
(iii)(A) Obtain the database, spreadsheet, or other documentation
used to generate the information in the RIN verification reports;
(B) Obtain all underlying documents that the QAP provider relied
upon to verify the RINs;
(C) Review the documents that the QAP auditor relied on to prepare
the reports obtained in paragraph (d)(2)(i) of this section, verify that
the underlying documents appropriately reflect the information reported
to the EPA,
[[Page 240]]
and identify as a finding any discrepancies between the underlying
documents and the information in the RIN verification reports;
(D) Compute the total number of current-year RINs and current-year
potentially invalid RINs verified at the start and end of each quarter,
as represented in these documents; and state whether this information
agrees with the party's reports to the EPA; and
(E) Verify that all parties were appropriately notified under Sec.
80.1474(b)(3) and report any missing notifications as a finding.
[75 FR 14863, Mar. 26, 2010]
Editorial Note: For Federal Register citations affecting Sec.
80.1464, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.govinfo.gov.
Sec. 80.1465 [Reserved]
Sec. 80.1466 What are the additional requirements under this subpart
for foreign renewable fuel producers and importers of renewable fuels?
(a) Applicability. This section only applies to foreign renewable
fuel producers that are located outside the United States, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern Mariana Islands (collectively
referred to in this section as ``the United States'').
(b) General requirements. A registered foreign renewable fuel
producer under this section must meet all requirements that apply to
renewable fuel producers under this subpart.
(c) Designation, RIN-generating foreign producer certification, and
product transfer documents. (1) Any registered foreign renewable fuel
producer must designate each batch of such renewable fuel as ``RFS-
FRRF'' at the time the renewable fuel is produced.
(2) On each occasion when RFS-FRRF is transferred for transport to a
vessel or loaded onto a vessel or other transportation mode for
transport to the United States, the RIN-generating foreign producer
shall prepare a certification for each batch of RFS-FRRF; the
certification shall include the report of the independent third party
under paragraph (d) of this section, and all the following additional
information:
(i) The name and EPA registration number of the company that
produced the RFS-FRRF.
(ii) The identification of the renewable fuel as RFS-FRRF.
(iii) The identification of the renewable fuel by type, D code, and
number of RINs generated.
(iv) The volume of RFS-FRRF, standardized per Sec. 80.1426(f)(8),
being transported, in gallons.
(3) On each occasion when any person transfers custody or title to
any RFS-FRRF prior to its being imported into the United States, it must
include all the following information as part of the product transfer
document information:
(i) Designation of the renewable fuel as RFS-FRRF.
(ii) The certification required under paragraph (c)(2) of this
section.
(d) Load port independent testing and producer identification. (1)
On each occasion that RFS-FRRF is loaded onto a vessel for transport to
the United States the RIN-generating foreign producer shall have an
independent third party do all the following:
(i) Inspect the vessel prior to loading and determine the volume of
any tank bottoms.
(ii) Determine the volume of RFS-FRRF, standardized per Sec.
80.1426(f)(8), loaded onto the vessel (exclusive of any tank bottoms
before loading).
(iii) Obtain the EPA-assigned registration number of the foreign
renewable fuel producer.
(iv) Determine the name and country of registration of the vessel
used to transport the RFS-FRRF to the United States.
(v) Determine the date and time the vessel departs the port serving
the RIN-generating foreign producer.
(vi) Review original documents that reflect movement and storage of
the RFS-FRRF from the RIN-generating foreign producer to the load port,
and from this review determine all the following:
(A) The facility at which the RFS-FRRF was produced.
(B) That the RFS-FRRF remained segregated from Non-RFS-FRRF and
[[Page 241]]
other RFS-FRRF produced by a different foreign producer.
(2) The independent third party shall submit a report to the
following:
(i) The RIN-generating foreign producer, containing the information
required under paragraph (d)(1) of this section, to accompany the
product transfer documents for the vessel.
(ii) EPA, containing the information required under paragraph (d)(1)
of this section, within thirty days following the date of the
independent third party's inspection. This report shall include a
description of the method used to determine the identity of the foreign
producer facility at which the renewable fuel was produced, assurance
that the renewable fuel remained segregated as specified in paragraph
(j)(1) of this section, and a description of the renewable fuel's
movement and storage between production at the source facility and
vessel loading.
(3) The independent third party must:
(i) Be approved in advance by EPA, based on a demonstration of
ability to perform the procedures required in this paragraph (d);
(ii) Be independent under the criteria specified in 40 CFR
1090.1805; and
(iii) Sign a commitment that contains the provisions specified in
paragraph (f) of this section with regard to activities, facilities and
documents relevant to compliance with the requirements of this paragraph
(d).
(e) Comparison of load port and port of entry testing. (1)(i) Any
RIN-generating foreign producer and any United States importer of RFS-
FRRF shall compare the results from the load port testing under
paragraph (d) of this section, with the port of entry testing as
reported under paragraph (k) of this section, for the volume of
renewable fuel, standardized per Sec. 80.1426(f)(8), except as
specified in paragraph (e)(1)(ii) of this section.
(ii) Where a vessel transporting RFS-FRRF offloads the renewable
fuel at more than one United States port of entry, the requirements of
paragraph (e)(1)(i) of this section do not apply at subsequent ports of
entry if the United States importer obtains a certification from the
vessel owner that the requirements of paragraph (e)(1)(i) of this
section were met and that the vessel has not loaded any renewable fuel
between the first United States port of entry and the subsequent ports
of entry.
(2)(i) If the temperature-corrected volumes, after accounting for
tank bottoms, determined at the port of entry and at the load port
differ by more than one percent, the number of RINs associated with the
renewable fuel shall be calculated based on the lesser of the two
volumes in paragraph (e)(1)(i) of this section.
(ii) Where the port of entry volume is the lesser of the two volumes
in paragraph (e)(1)(i) of this section, the importer shall calculate the
difference between the number of RINs originally assigned by the RIN-
generating foreign producer and the number of RINs calculated under
Sec. 80.1426 for the volume of renewable fuel as measured at the port
of entry, and acquire and retire that amount of RINs in accordance with
paragraph (k)(3) of this section.
(f) Foreign producer commitments. Any foreign renewable fuel
producer shall commit to and comply with the following provisions as a
condition to being registered as a foreign renewable fuel producer under
this subpart:
(1) Any EPA inspector or auditor must be given full, complete, and
immediate access to conduct inspections and audits of the foreign
renewable fuel producer facility.
(i) Inspections and audits may be either announced in advance by
EPA, or unannounced.
(ii) Access will be provided to any location where:
(A) Renewable fuel is produced;
(B) Documents related to renewable fuel producer operations are
kept; and
(C) Renewable fuel is stored or transported between the foreign
renewable fuel producer and the United States, including storage tanks,
vessels and pipelines.
(iii) EPA inspectors and auditors may be EPA employees or
contractors to EPA.
(iv) Any documents requested that are related to matters covered by
inspections and audits must be provided to an EPA inspector or auditor
on request.
(v) Inspections and audits may include review and copying of any
documents related to the following:
[[Page 242]]
(A) The volume of renewable fuel.
(B) The proper classification of renewable fuel as being RFS-FRRF.
(C) Transfers of title or custody to renewable fuel.
(D) Work performed and reports prepared by independent third parties
and by independent auditors under the requirements of this section,
including work papers.
(vi) Inspections and audits by EPA may include interviewing
employees.
(vii) Any employee of the foreign renewable fuel producer must be
made available for interview by the EPA inspector or auditor, on
request, within a reasonable time period.
(viii) English language translations of any documents must be
provided to an EPA inspector or auditor, on request, within 10 business
days.
(ix) English language interpreters must be provided to accompany EPA
inspectors and auditors, on request.
(2) An agent for service of process located in the District of
Columbia shall be named, and service on this agent constitutes service
on the foreign renewable fuel producer or any employee of the foreign
renewable fuel producer for any action by EPA or otherwise by the United
States related to the requirements of this subpart.
(3) The forum for any civil or criminal enforcement action related
to the provisions of this section for violations of the Clean Air Act or
regulations promulgated thereunder shall be governed by the Clean Air
Act, including the EPA administrative forum where allowed under the
Clean Air Act.
(4) United States substantive and procedural laws shall apply to any
civil or criminal enforcement action against the foreign renewable fuel
producer or any employee of the foreign renewable fuel producer related
to the provisions of this section.
(5) Applying to be an approved foreign renewable fuel producer under
this section, or producing or exporting renewable fuel under such
approval, and all other actions to comply with the requirements of this
subpart relating to such approval constitute actions or activities
covered by and within the meaning of the provisions of 28 U.S.C.
1605(a)(2), but solely with respect to actions instituted against the
foreign renewable fuel producer, its agents and employees in any court
or other tribunal in the United States for conduct that violates the
requirements applicable to the foreign renewable fuel producer under
this subpart, including conduct that violates the False Statements
Accountability Act of 1996 (18 U.S.C. 1001) and section 113(c)(2) of the
Clean Air Act (42 U.S.C. 7413).
(6) The foreign renewable fuel producer, or its agents or employees,
will not seek to detain or to impose civil or criminal remedies against
EPA inspectors or auditors for actions performed within the scope of EPA
employment or contract related to the provisions of this section.
(7) The commitment required by this paragraph shall be signed by the
owner or president of the foreign renewable fuel producer company.
(8) In any case where renewable fuel produced at a foreign renewable
fuel production facility is stored or transported by another company
between the production facility and the vessel that transports the
renewable fuel to the United States, the foreign renewable fuel producer
shall obtain from each such other company a commitment that meets the
requirements specified in paragraphs (f)(1) through (7) of this section,
and these commitments shall be included in the foreign renewable fuel
producer's application to be an approved foreign renewable fuel producer
under this subpart.
(g) Sovereign immunity. By submitting an application to be an
approved foreign renewable fuel producer under this subpart, or by
producing and exporting renewable fuel to the United States under such
approval, the foreign renewable fuel producer, and its agents and
employees, without exception, become subject to the full operation of
the administrative and judicial enforcement powers and provisions of the
United States without limitation based on sovereign immunity, with
respect to actions instituted against the foreign renewable fuel
producer, its agents and employees in any court or other tribunal in the
United States for conduct that violates the requirements applicable to
the foreign renewable fuel producer under this subpart, including
[[Page 243]]
conduct that violates the False Statements Accountability Act of 1996
(18 U.S.C. 1001) and section 113(c)(2) of the Clean Air Act (42 U.S.C.
7413).
(h) Bond posting. Any RIN-generating foreign producer shall meet the
following requirements as a condition to approval as a RIN-generating
foreign producer under this subpart:
(1) The RIN-generating foreign producer must post a bond of the
amount calculated using the following equation.
Bond = G * $0.22
Where:
Bond = Amount of the bond in U.S. dollars.
G = The greater of: (1) The largest volume of renewable fuel produced by
the RIN-generating foreign producer and exported to the United
States, in gallons, during a single calendar year among the
five preceding calendar years; or (2) The largest volume of
renewable fuel that the RIN-generating foreign producers
expects to export to the United States during any calendar
year identified in the Production Outlook Report required by
Sec. 80.1449. If the volume of renewable fuel exported to the
United States increases above the largest volume identified in
the Production Outlook Report during any calendar year, the
RIN-generating foreign producer must increase the bond to
cover the shortfall within 90 days.
(2) Bonds must be obtained in the proper amount from a third-party
surety agent that is payable to satisfy United States administrative or
judicial judgments against the foreign producer, provided EPA agrees in
advance as to the third party and the nature of the surety agreement.
(3) Bonds posted under this paragraph (h) shall:
(i) Be used to satisfy any judicial judgment that results from an
administrative or judicial enforcement action for conduct in violation
of this subpart, including where such conduct violates the False
Statements Accountability Act of 1996 (18 U.S.C. 1001) and section
113(c)(2) of the Clean Air Act (42 U.S.C. 7413);
(ii) Be provided by a corporate surety that is listed in the United
States Department of Treasury Circular 570 ``Companies Holding
Certificates of Authority as Acceptable Sureties on Federal Bonds''; and
(iii) Include a commitment that the bond will remain in effect for
at least five years following the end of latest annual reporting period
that the RIN-generating foreign producer produces renewable fuel
pursuant to the requirements of this subpart.
(4) On any occasion a RIN-generating foreign producer bond is used
to satisfy any judgment, the RIN-generating foreign producer shall
increase the bond to cover the amount used within 90 days of the date
the bond is used.
(i) English language reports. Any document submitted to EPA by a
foreign renewable fuel producer shall be in English, or shall include an
English language translation.
(j) Prohibitions. (1) No person may combine RFS-FRRF with any Non-
RFS-FRRF, and no person may combine RFS-FRRF with any RFS-FRRF produced
at a different production facility, until the importer has met all the
requirements of paragraph (k) of this section.
(2) No foreign renewable fuel producer or other person may cause
another person to commit an action prohibited in paragraph (j)(1) of
this section, or that otherwise violates the requirements of this
section.
(3) No foreign renewable fuel producer or importer may generate RINs
for the same volume of renewable fuel.
(4) A foreign renewable fuel producer is prohibited from generating
RINs in excess of the number for which the bond requirements of this
section have been satisfied.
(k) Requirements for United States importers of RFS-FRRF. Any United
States importers of RFS-FRRF shall meet all the following requirements:
(1) Renewable fuel shall be classified as RFS-FRRF according to the
designation by the RIN-generating foreign producer if this designation
is supported by product transfer documents prepared by the foreign
producer as required in paragraph (c) of this section.
(2) For each renewable fuel batch classified as RFS-FRRF, any United
States importer shall have an independent third party do all the
following:
(i) Determine the volume of renewable fuel, standardized per Sec.
80.1426(f)(8), in the vessel.
[[Page 244]]
(ii) Use the RIN-generating foreign producer's RFS-FRRF
certification to determine the name and EPA-assigned registration number
of the RIN-generating foreign producer that produced the RFS-FRRF.
(iii) Determine the name and country of registration of the vessel
used to transport the RFS-FRRF to the United States.
(iv) Determine the date and time the vessel arrives at the United
States port of entry.
(3) Where the importer is required to retire RINs under paragraph
(e)(2) of this section, the importer must report the retired RINs in the
applicable reports under Sec. 80.1451.
(4) Any importer shall submit reports within 30 days following the
date any vessel transporting RFS-FRRF arrives at the United States port
of entry to all the following:
(i) EPA, containing the information determined under paragraph
(k)(2) of this section.
(ii) The RIN-generating foreign producer, containing the information
determined under paragraph (k)(2)(i) of this section, and including
identification of the port at which the product was offloaded, and any
RINs retired under paragraph (e)(2) of this section.
(5) Any United States importer shall meet all other requirements of
this subpart for any imported renewable fuel that is not classified as
RFS-FRRF under paragraph (k)(1) of this section.
(l) Truck imports of RFS-FRRF produced by a RIN-generating foreign
producer. (1) Any RIN-generating foreign producer whose RFS-FRRF is
transported into the United States by truck may petition EPA to use
alternative procedures to meet all the following requirements:
(i) Certification under paragraph (c)(2) of this section.
(ii) Load port and port of entry testing under paragraphs (d) and
(e) of this section.
(iii) Importer testing under paragraph (k)(2) of this section.
(2) These alternative procedures must ensure RFS-FRRF remains
segregated from Non-RFS-FRRF until it is imported into the United
States. The petition will be evaluated based on whether it adequately
addresses all of the following:
(i) Contracts with any facilities that receive and/or transport RFS-
FRRF that prohibit the commingling of RFS-FRRF with Non-RFS-FRRF or RFS-
FRRF from other foreign renewable fuel producers.
(ii) Attest procedures to be conducted annually by an independent
third party that review loading records and import documents based on
volume reconciliation to confirm that all RFS-FRRF remains segregated.
(3) The petition described in this section must be submitted to EPA
along with the application for approval as a RIN-generating foreign
producer under this subpart.
(m) Additional attest requirements for producers of RFS-FRRF. The
following additional procedures shall be carried out by any producer of
RFS-FRRF as part of the attest engagement required for renewable fuel
producers under this subpart M.
(1) Obtain listings of all tenders of RFS-FRRF. Agree the total
volume of tenders from the listings to the volumes determined by the
third party under paragraph (d) of this section.
(2) For each tender under paragraph (m)(1) of this section, where
the renewable fuel is loaded onto a marine vessel, report as a finding
the name and country of registration of each vessel, and the volumes of
RFS-FRRF loaded onto each vessel.
(3) Select a sample from the list of vessels identified in paragraph
(m)(2) of this section used to transport RFS-FRRF, in accordance with
the guidelines in 40 CFR 1090.1805, and for each vessel selected perform
all the following:
(i) Obtain the report of the independent third party, under
paragraph (d) of this section, and of the United States importer under
paragraph (k) of this section.
(A) Agree the information in these reports with regard to vessel
identification and renewable fuel volume.
(B) Identify, and report as a finding, each occasion the load port
and port of entry volume results differ by more than the amount allowed
in paragraph (e) of this section, and determine
[[Page 245]]
whether the importer retired the appropriate amount of RINs as required
under paragraph (e)(2) of this section, and submitted the applicable
reports under Sec. 80.1451 in accordance with paragraph (k)(4) of this
section.
(ii) Obtain the documents used by the independent third party to
determine transportation and storage of the RFS-FRRF from the RIN-
generating foreign producer's facility to the load port, under paragraph
(d) of this section. Obtain tank activity records for any storage tank
where the RFS-FRRF is stored, and activity records for any mode of
transportation used to transport the RFS-FRRF prior to being loaded onto
the vessel. Use these records to determine whether the RFS-FRRF was
produced at the RIN-generating foreign producer's facility that is the
subject of the attest engagement, and whether the RFS-FRRF was mixed
with any Non-RFS-FRRF or any RFS-FRRF produced at a different facility.
(4) Select a sample from the list of vessels identified in paragraph
(m)(2) of this section used to transport RFS-FRRF, in accordance with
the guidelines in 40 CFR 1090.1805, and for each vessel selected perform
the following:
(i) Obtain a commercial document of general circulation that lists
vessel arrivals and departures, and that includes the port and date of
departure of the vessel, and the port of entry and date of arrival of
the vessel.
(ii) Agree the vessel's departure and arrival locations and dates
from the independent third party and United States importer reports to
the information contained in the commercial document.
(5) Obtain a separate listing of the tenders under this paragraph
(m)(5) where the RFS-FRRF is loaded onto a marine vessel. Select a
sample from this listing in accordance with the guidelines in 40 CFR
1090.1805, and obtain a commercial document of general circulation that
lists vessel arrivals and departures, and that includes the port and
date of departure and the ports and dates where the renewable fuel was
offloaded for the selected vessels. Determine and report as a finding
the country where the renewable fuel was offloaded for each vessel
selected.
(6) In order to complete the requirements of this paragraph (m) an
auditor shall:
(i) Be independent of the RIN-generating foreign producer;
(ii) Be licensed as a Certified Public Accountant in the United
States and a citizen of the United States, or be approved in advance by
EPA based on a demonstration of ability to perform the procedures
required in 40 CFR 1090.1800, Sec. 80.1464, and this paragraph (m); and
(iii) Sign a commitment that contains the provisions specified in
paragraph (f) of this section with regard to activities and documents
relevant to compliance with the requirements of 40 CFR 1090.1800, Sec.
80.1464, and this paragraph (m).
(n) Withdrawal or suspension of foreign renewable fuel producer
approval. EPA may withdraw or suspend a foreign renewable fuel
producer's approval where any of the following occur:
(1) A foreign renewable fuel producer fails to meet any requirement
of this section.
(2) A foreign government fails to allow EPA inspections or audits as
provided in paragraph (f)(1) of this section.
(3) A foreign renewable fuel producer asserts a claim of, or a right
to claim, sovereign immunity in an action to enforce the requirements in
this subpart.
(4) A foreign renewable fuel producer fails to pay a civil or
criminal penalty that is not satisfied using the foreign renewable fuel
producer bond specified in paragraph (h) of this section.
(o) Additional requirements for applications, reports, and
certificates. Any application for approval as a foreign renewable fuel
producer, alternative procedures under paragraph (l) of this section,
any report, certification, or other submission required under this
section shall be:
(1) Submitted in accordance with procedures specified by EPA,
including use of any forms that may be specified by EPA.
(2) Signed by the president or owner of the foreign renewable fuel
producer company, or by that person's immediate designee, and shall
contain the following declarations:
(i) ``I hereby certify:
[[Page 246]]
(A) That I have actual authority to sign on behalf of and to bind
[NAME OF FOREIGN RENEWABLE FUEL PRODUCER] with regard to all statements
contained herein;
(B) That I am aware that the information contained herein is being
Certified, or submitted to the United States Environmental Protection
Agency, under the requirements of 40 CFR part 80, subpart M, and that
the information is material for determining compliance under these
regulations; and
(C) That I have read and understand the information being Certified
or submitted, and this information is true, complete and correct to the
best of my knowledge and belief after I have taken reasonable and
appropriate steps to verify the accuracy thereof.''
(ii) ``I affirm that I have read and understand the provisions of 40
CFR part 80, subpart M, including 40 CFR 80.1466 apply to [NAME OF
FOREIGN RENEWABLE FUEL PRODUCER]. Pursuant to Clean Air Act section
113(c) and 18 U.S.C. 1001, the penalty for furnishing false, incomplete
or misleading information in this certification or submission is a fine
of up to $10,000 U.S., and/or imprisonment for up to five years.''.
(p) Requirements for non-RIN-generating foreign producer. Any non-
RIN-generating foreign producer must comply with the requirements of
this section beginning on the effective date of the final rule or prior
to EPA acceptance, whichever is later.
[75 FR 14863, Mar. 26, 2010, as amended at 77 FR 1357, Jan. 9, 2012; 85
FR 7081, Feb. 6, 2020; 85 FR 78467, Dec. 4, 2020; 88 FR 44591, July 12,
2023]
Sec. 80.1467 What are the additional requirements under this subpart
for a foreign RIN owner?
(a) Foreign RIN owner. For purposes of this subpart, a foreign RIN
owner is a person located outside the United States, the Commonwealth of
Puerto Rico, the Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands (collectively referred to
in this section as ``the United States'') that has been approved by EPA
to own RINs.
(b) General requirement. An approved foreign RIN owner must meet all
requirements that apply to parties who own RINs under this subpart.
(c) Foreign RIN owner commitments. Any person shall commit to and
comply with the provisions contained in this paragraph (c) as a
condition to being approved as a foreign RIN owner under this subpart.
(1) Any United States Environmental Protection Agency inspector or
auditor must be given full, complete, and immediate access to conduct
inspections and audits of the foreign RIN owner's place of business.
(i) Inspections and audits may be either announced in advance by
EPA, or unannounced.
(ii) Access will be provided to any location where documents related
to RINs the foreign RIN owner has obtained, sold, transferred or held
are kept.
(iii) Inspections and audits may be by EPA employees or contractors
to EPA.
(iv) Any documents requested that are related to matters covered by
inspections and audits must be provided to an EPA inspector or auditor
on request.
(v) Inspections and audits by EPA may include review and copying of
any documents related to the following:
(A) Transfers of title to RINs.
(B) Work performed and reports prepared by independent auditors
under the requirements of this section, including work papers.
(vi) Inspections and audits by EPA may include interviewing
employees.
(vii) Any employee of the foreign RIN owner must be made available
for interview by the EPA inspector or auditor, on request, within a
reasonable time period.
(viii) English language translations of any documents must be
provided to an EPA inspector or auditor, on request, within 10 business
days.
(ix) English language interpreters must be provided to accompany EPA
inspectors and auditors, on request.
(2) An agent for service of process located in the District of
Columbia shall be named, and service on this agent constitutes service
on the foreign RIN owner or any employee of the foreign RIN owner for
any action by EPA or
[[Page 247]]
otherwise by the United States related to the requirements of this
subpart.
(3) The forum for any civil or criminal enforcement action related
to the provisions of this section for violations of the Clean Air Act or
regulations promulgated thereunder shall be governed by the Clean Air
Act, including the EPA administrative forum where allowed under the
Clean Air Act.
(4) United States substantive and procedural laws shall apply to any
civil or criminal enforcement action against the foreign RIN owner or
any employee of the foreign RIN owner related to the provisions of this
section.
(5) Submitting an application to be a foreign RIN owner, and all
other actions to comply with the requirements of this subpart constitute
actions or activities covered by and within the meaning of the
provisions of 28 U.S.C. 1605(a)(2), but solely with respect to actions
instituted against the foreign RIN owner, its agents and employees in
any court or other tribunal in the United States for conduct that
violates the requirements applicable to the foreign RIN owner under this
subpart, including conduct that violates the False Statements
Accountability Act of 1996 (18 U.S.C. 1001) and section 113(c)(2) of the
Clean Air Act (42 U.S.C. 7413).
(6) The foreign RIN owner, or its agents or employees, will not seek
to detain or to impose civil or criminal remedies against EPA inspectors
or auditors, whether EPA employees or EPA contractors, for actions
performed within the scope of EPA employment related to the provisions
of this section.
(7) The commitment required by this paragraph (c) shall be signed by
the owner or president of the foreign RIN owner business.
(d) Sovereign immunity. By submitting an application to be a foreign
RIN owner under this subpart, the foreign entity, and its agents and
employees, without exception, become subject to the full operation of
the administrative and judicial enforcement powers and provisions of the
United States without limitation based on sovereign immunity, with
respect to actions instituted against the foreign RIN owner, its agents
and employees in any court or other tribunal in the United States for
conduct that violates the requirements applicable to the foreign RIN
owner under this subpart, including conduct that violates the False
Statements Accountability Act of 1996 (18 U.S.C. 1001) and section
113(c)(2) of the Clean Air Act (42 U.S.C. 7413).
(e) Bond posting. Any foreign entity shall meet the requirements of
this paragraph (e) as a condition to approval as a foreign RIN owner
under this subpart.
(1) The foreign entity must post a bond of the amount calculated
using the following equation:
Bond = G * $ 0.22
Where:
Bond = Amount of the bond in U.S. dollars.
G = The total of the number of gallon-RINs the foreign entity expects to
obtain, sell, transfer, or hold during the first calendar year
that the foreign entity is a RIN owner, plus the number of
gallon-RINs the foreign entity expects to obtain, sell,
transfer, or hold during the next four calendar years. After
the first calendar year, the bond amount must be based on the
actual number of gallon-RINs obtained, sold, or transferred so
far during the current calendar year plus the number of
gallon-RINs obtained, sold, or transferred during the four
calendar years immediately preceding the current calendar
year. For any year for which there were fewer than four
preceding years in which the foreign entity obtained, sold, or
transferred RINs, the bond must be based on the total of the
number of gallon-RINs sold or transferred so far during the
current calendar year plus the number of gallon-RINs obtained,
sold, or transferred during any immediately preceding calendar
years in which the foreign entity owned RINs, plus the number
of gallon-RINs the foreign entity expects to obtain, sell or
transfer during subsequent calendar years, the total number of
years not to exceed four calendar years in addition to the
current calendar year.
(2) Bonds must be obtained in the proper amount from a third-party
surety agent that is payable to satisfy United States administrative or
judicial judgments against the foreign RIN owner, provided EPA agrees in
advance as to the third party and the nature of the surety agreement.
(3) All the following shall apply to bonds posted under this
paragraph (e); bonds shall:
[[Page 248]]
(i) Be used to satisfy any judicial judgment that results from an
administrative or judicial enforcement action for conduct in violation
of this subpart, including where such conduct violates the False
Statements Accountability Act of 1996 (18 U.S.C. 1001) and section
113(c)(2) of the Clean Air Act (42 U.S.C. 7413).
(ii) Be provided by a corporate surety that is listed in the United
States Department of Treasury Circular 570 ``Companies Holding
Certificates of Authority as Acceptable Sureties on Federal Bonds''.
(iii) Include a commitment that the bond will remain in effect for
at least five years following the end of latest reporting period in
which the foreign RIN owner obtains, sells, transfers, or holds RINs.
(4) On any occasion a foreign RIN owner bond is used to satisfy any
judgment, the foreign RIN owner shall increase the bond to cover the
amount used within 90 days of the date the bond is used.
(f) English language reports. Any document submitted to EPA by a
foreign RIN owner shall be in English, or shall include an English
language translation.
(g) Prohibitions. (1) A foreign RIN owner is prohibited from
obtaining, selling, transferring, or holding any RIN that is in excess
of the number for which the bond requirements of this section have been
satisfied.
(2) Any RIN that is obtained, sold, transferred, or held that is in
excess of the number for which the bond requirements of this section
have been satisfied is an invalid RIN under Sec. 80.1431.
(3) Any RIN that is obtained from a person located outside the
United States that is not an approved foreign RIN owner under this
section is an invalid RIN under Sec. 80.1431.
(4) No foreign RIN owner or other person may cause another person to
commit an action prohibited in this paragraph (g), or that otherwise
violates the requirements of this section.
(h) Additional attest requirements for foreign RIN owners. The
following additional requirements apply to any foreign RIN owner as part
of the attest engagement required for RIN owners under this subpart M.
(1) The attest auditor must be independent of the foreign RIN owner.
(2) The attest auditor must be licensed as a Certified Public
Accountant in the United States and a citizen of the United States, or
be approved in advance by EPA based on a demonstration of ability to
perform the procedures required in 40 CFR 1090.1800 and Sec. 80.1464.
(3) The attest auditor must sign a commitment that contains the
provisions specified in paragraph (c) of this section with regard to
activities and documents relevant to compliance with the requirements of
40 CFR 1090.1800 and Sec. 80.1464.
(i) Withdrawal or suspension of foreign RIN owner status. EPA may
withdraw or suspend its approval of a foreign RIN owner where any of the
following occur:
(1) A foreign RIN owner fails to meet any requirement of this
section, including, but not limited to, the bond requirements.
(2) A foreign government fails to allow EPA inspections as provided
in paragraph (c)(1) of this section.
(3) A foreign RIN owner asserts a claim of, or a right to claim,
sovereign immunity in an action to enforce the requirements in this
subpart.
(4) A foreign RIN owner fails to pay a civil or criminal penalty
that is not satisfied using the foreign RIN owner bond specified in
paragraph (e) of this section.
(j) Additional requirements for applications, reports and
certificates. Any application for approval as a foreign RIN owner, any
report, certification, or other submission required under this section
shall be:
(1) Submitted in accordance with procedures specified by EPA,
including use of any forms that may be specified by EPA.
(2) Signed by the president or owner of the foreign RIN owner
company, or by that person's immediate designee, and shall contain the
following declaration:
I hereby certify: (1) That I have actual authority to sign on behalf
of and to bind [INSERT NAME OF FOREIGN RIN OWNER] with regard to all
statements contained herein; (2) that I am aware that the information
contained herein is being Certified, or
[[Page 249]]
submitted to the United States Environmental Protection Agency, under
the requirements of 40 CFR part 80, subpart M, and that the information
is material for determining compliance under these regulations; and (3)
that I have read and understand the information being Certified or
submitted, and this information is true, complete and correct to the
best of my knowledge and belief after I have taken reasonable and
appropriate steps to verify the accuracy thereof. I affirm that I have
read and understand the provisions of 40 CFR part 80, subpart M,
including 40 CFR 80.1467 apply to [INSERT NAME OF FOREIGN RIN OWNER].
Pursuant to Clean Air Act section 113(c) and 18 U.S.C. 1001, the penalty
for furnishing false, incomplete or misleading information in this
certification or submission is a fine of up to $10,000 U.S., and/or
imprisonment for up to five years.
[75 FR 14863, Mar. 26, 2010, as amended at 77 FR 1358, Jan. 9, 2012; 85
FR 78467, Dec. 4, 2020; 88 FR 44591, July 12, 2023]
Sec. 80.1468 [Reserved]
Sec. 80.1469 Requirements for Quality Assurance Plans.
This section specifies the requirements for Quality Assurance Plans
(QAPs) for renewable fuels and biointermediates.
(a) Option A QAP Requirements, for Option A QAPs that were performed
during the interim period.
(1) Feedstock-related components. (i) Components requiring ongoing
monitoring:
(A) Feedstocks are renewable biomass.
(B) Feedstocks are being separated according to a separation plan,
if applicable under Sec. 80.1426(f)(5)(ii).
(C) Crop and crop residue feedstocks meet land use restrictions, or
alternatively the aggregate compliance provisions of Sec. 80.1454(g).
(D) If applicable, verify that feedstocks with additional
recordkeeping requirements meet requirements of Sec. 80.1454(d).
(E) Feedstocks are valid for the D code being used, and are
consistent with information recorded in EMTS.
(F) Feedstock is consistent with production process and D code being
used from the approved pathway.
(G) Feedstock is not renewable fuel for which RINs were previously
generated.
(ii) Components requiring quarterly monitoring:
(A) Separated food waste or separated yard waste plan is accepted
and up to date, if applicable under Sec. 80.1426(f)(5)(ii).
(B) Separated municipal solid waste plan is approved and up to date,
if applicable under Sec. 80.1426(f)(5)(ii).
(C) Contracts or agreements for feedstock acquisition are sufficient
for facility production.
(D) Feedstock processing and storage equipment are sufficient and
are consistent with the most recent engineering review under Sec.
80.1450(b)(2).
(E) If applicable, accuracy of feedstock energy FE calculation
factors related to feedstocks, including average moisture content m and
feedstock energy content E.
(2) Production process-related components. (i) Components requiring
ongoing monitoring:
(A) Production process is consistent with that reported in EMTS.
(B) Production process is consistent with D code being used from the
approved pathway.
(C) Certificates of analysis verifying fuel type and quality, as
applicable.
(ii) Components requiring quarterly monitoring:
(A) Mass and energy balances are appropriate for type and size of
facility.
(B) Workforce size is appropriate for type and size of facility, and
sufficient workers are on site for facility operations.
(C) If applicable, process-related factors used in feedstock energy
FE calculation are accurate, in particular the converted fraction CF.
(D) Verify existence of quality process controls designed to ensure
that fuel continues to meet applicable property and quality
specifications.
(E) Volume production is consistent with that reported to the EPA
and EIA, as well as other federal or state reporting.
(F) Volume production is consistent with storage and distribution
capacity.
(G) Volume production capacity is consistent with RFS registration.
(3) RIN generation-related components. (i) Components requiring
ongoing monitoring:
[[Page 250]]
(A) Standardization of volumes pursuant to Sec. 80.1426(f)(8) are
accurate.
(B) Renewable fuel type matches the D code being used.
(C) RIN generation is consistent with wet gallons produced or
imported.
(D) Fuel shipments are consistent with production volumes.
(E) If applicable, renewable content R is accurate pursuant to Sec.
80.1426(f)(9).
(F) Equivalence value EqV is accurate and appropriate.
(G) Renewable fuel was intended and sold for qualifying uses as
transportation fuel, heating oil, or jet fuel.
(H) Verify that appropriate RIN generation calculations are being
followed under Sec. 80.1426(f)(3), (f)(4), or (f)(5), as applicable.
(ii) Components requiring quarterly monitoring:
(A) Registration, reporting and recordkeeping components.
(B) [Reserved]
(4) RIN separation-related components. (i) Components requiring
ongoing monitoring:
(A) If applicable, verify that RIN separation is appropriate under
Sec. 80.1429(b)(4).
(B) If applicable, verify that RINs were retired for any fuel that
the producer produced and exported.
(ii) Components requiring quarterly monitoring:
(A) Verify that annual attestation report is accurate.
(B) [Reserved]
(b) Option B QAP Requirements, for Option B QAPs that were performed
during the interim period. All components specified in this paragraph
(b) require quarterly monitoring, except for paragraph (b)(4)(iii) of
this section, which must be done annually.
(1) Feedstock-related components. (i) Feedstocks are renewable
biomass.
(ii) If applicable, separated food waste or separated yard waste
plan under Sec. 80.1426(f)(5)(ii) is accepted and up to date.
(iii) If applicable, separated municipal solid waste plan under
Sec. 80.1426(f)(5)(ii) is approved and current.
(iv) Feedstocks are being separated according to a separation plan,
if applicable under Sec. 80.1426(f)(5)(ii).
(v) Crop and crop residue feedstocks meet land use restrictions, or
alternatively the aggregate compliance provisions of Sec. 80.1454(g).
(vi) Feedstock is consistent with production process and D code
being used from the approved pathway, and is consistent with information
recorded in EMTS.
(vii) Feedstock is not renewable fuel for which RINs were previously
generated.
(viii) If applicable, accuracy of feedstock energy FE calculation
factors related to feedstocks, including average moisture content m and
feedstock energy content E.
(2) Production process-related components. (i) Production process is
consistent with that reported in EMTS.
(ii) Production process is consistent with D code being used from
the approved pathway.
(iii) Mass and energy balances are appropriate for type and size of
facility.
(iv) If applicable, process-related factors used in feedstock energy
FE calculation are accurate, in particular the converted fraction CF.
(3) RIN generation-related components. (i) Renewable fuel was
intended and sold for qualifying uses as transportation fuel, heating
oil, or jet fuel.
(ii) Certificates of analysis verifying fuel type and quality, as
applicable.
(iii) Renewable fuel type matches the D code being used.
(iv) If applicable, renewable content R is accurate pursuant to
Sec. 80.1426(f)(9).
(v) Equivalence value EqV is accurate and appropriate.
(vi) Volume production capacity is consistent with RFS registration.
(vii) Verify that appropriate RIN generation calculations are being
followed under Sec. 80.1426(f)(3), (f)(4), or (f)(5), as applicable.
(4) RIN separation-related components. (i) If applicable, verify
that RIN separation is appropriate under Sec. 80.1429(b)(4).
(ii) Verify that fuel that is exported was not used to generate
RINs, or alternatively that were generated but retired.
(iii) Verify that annual attestation report is accurate.
(c) QAP Requirements. All components specified in this paragraph (c)
require
[[Page 251]]
quarterly monitoring, except for paragraph (c)(4)(iii) of this section
which must be done annually.
(1) Feedstock-related components. (i) Feedstocks are renewable
biomass.
(ii) If applicable, plans under Sec. 80.1426(f)(5)(ii) are accepted
and up to date.
(iii) If applicable, separated municipal solid waste plan under
Sec. 80.1426(f)(5) is approved and current.
(iv) Feedstocks are being separated according to a separation plan,
if applicable under Sec. 80.1426(f)(5).
(v) Crop and crop residue feedstocks meet land use restrictions, or
alternatively the aggregate compliance provisions of Sec. 80.1454(g).
(vi) Feedstock(s) and biointermediate(s) are consistent with
production process and D code being used as permitted under the approved
pathway and is consistent with information recorded in EMTS.
(vii) Feedstock(s) and biointermediate(s) are not renewable fuel for
which RINs were previously generated unless the RINs were generated
under Sec. 80.1426(c)(6). For renewable fuels that have RINs generated
under Sec. 80.1426(c)(6), verify that renewable fuels used as a
feedstock meet all applicable requirements of this paragraph (c)(1).
(viii) If applicable, accuracy of feedstock energy FE calculation
factors related to feedstocks, including average moisture content m and
feedstock energy content E.
(2) Production process-related components. (i) Production process is
consistent with the renewable fuel producer or biointermediate
producer's registration under Sec. 80.1450(b).
(ii) Mass and energy balances are appropriate for type and size of
facility.
(iii) If applicable, process-related factors used in feedstock
energy FE calculation are accurate, in particular the converted fraction
CF, pursuant to Sec. 80.1426(f)(3).
(3) RIN generation-related components. (i) If applicable, renewable
fuel was designated for qualifying uses as transportation fuel, heating
oil, or jet fuel in the covered location pursuant to Sec. 80.1453.
(ii) Certificates of analysis verifying fuel type and quality, as
applicable.
(iii) Renewable fuel type matches the D code being used.
(iv) If applicable, renewable content R is accurate pursuant to
Sec. 80.1426(f)(9).
(v) Equivalence value EqV is accurate and appropriate.
(vi) Volume production capacity is consistent with RFS registration.
(vii) Verify that appropriate RIN generation calculations are being
followed under Sec. 80.1426(f)(3), (f)(4), or (f)(5), as applicable.
(viii) RIN generation is consistent with wet gallons produced or
imported.
(4) Other RIN-related components. (i) If applicable, verify that RIN
separation is appropriate under Sec. 80.1429(b).
(ii) Verify that fuel that is exported was not used to generate
RINs, or alternatively that were generated but retired pursuant to Sec.
80.1430.
(iii) Verify that annual attestation report is accurate.
(5) Representative sampling. Independent third-party auditors may
use a representative sample of batches of renewable fuel or
biointermediate in accordance with the procedures described in 40 CFR
1090.1805 for all components of this paragraph (c) except for paragraphs
(c)(1)(ii) and (iii), (c)(2)(ii), (c)(3)(vi), and (c)(4)(ii) and (iii)
of this section. If a facility produces both a renewable fuel and a
biointermediate, the independent third-party auditor must select
separate representative samples for the renewable fuel and
biointermediate.
(6) Documentation. Independent third-party auditors must review all
relevant registration information under Sec. 80.1450, reporting
information under Sec. 80.1451, and recordkeeping information under
Sec. 80.1454, as well as any other relevant information and
documentation required under this part, to verify elements in a QAP
approved by EPA under this section.
(d) In addition to a general QAP encompassing elements common to all
pathways, for each QAP there must be at least one pathway-specific plan
for an approved pathway, which must contain elements specific to
particular feedstocks, production processes, and fuel types, as
applicable.
(e) Submission and approval of a QAP. (1) Each independent third-
party auditor shall annually submit a general and
[[Page 252]]
at least one pathway-specific QAP to the EPA which demonstrates
adherence to the requirements of paragraphs (a) and (d), (b) and (d), or
(c) and (d) of this section, as applicable, and request approval on
forms and using procedures specified by EPA.
(2) No third-party independent auditor may present a QAP as approved
by the EPA without having received written approval from the EPA.
(3) A QAP is approved on the date that the EPA notifies the third-
party independent auditor of such approval.
(4) The EPA may revoke its approval of a QAP for cause, including,
but not limited to, an EPA determination that the approved QAP has
proven to be inadequate in practice.
(5) The EPA may void ab initio its approval of a QAP upon the EPA's
determination that the approval was based on false information,
misleading information, or incomplete information, or if there was a
failure to fulfill, or cause to be fulfilled, any of the requirements of
the QAP.
(f) Conditions for revisions of a QAP. (1) A new QAP must be
submitted to EPA according to paragraph (e) of this section and the
independent third-party auditor must update their registration according
to Sec. 80.1450(g)(9) whenever any of the following changes occur at a
renewable fuel or biointermediate production facility audited by an
independent third-party auditor and the auditor does not possess an
appropriate pathway-specific QAP that encompasses the change:
(i) Change in feedstock or biointermediates.
(ii) Change in type of fuel or biointermediate produced.
(iii) Change in facility operations or equipment that may impact the
capability of the QAP to verify that RINs are validly generated or
biointermediates are properly produced.
(2) A QAP ceases to be valid as the basis for verifying RINs or a
biointermediate under a new pathway until a new pathway-specific QAP,
submitted to the EPA under this paragraph (f), is approved pursuant to
paragraph (e) of this section.
[79 FR 42119, July 18, 2014, as amended at 85 FR 7083, Feb. 6, 2020; 85
FR 78467, Dec. 4, 2020; 87 FR 39673, July 1, 2022; 88 FR 44592, July 12,
2023]
Sec. 80.1470 RIN replacement mechanisms for Option A independent
third party auditors.
(a) Applicability. This section applies to independent third-party
auditors using a QAP approved under Option A pursuant to Sec.
80.1469(a) and (d) during the interim period.
(b) Requirements. An independent third party auditor must establish
or participate in the establishment of a RIN replacement mechanism. The
RIN replacement mechanism must fulfill, at a minimum, all the following
conditions:
(1) The RIN replacement mechanism must be capable of fulfilling the
independent third party auditor's RIN replacement responsibility, as
described in Sec. 80.1474(b)(5)(i).
(2) The independent third party auditor is responsible for
calculating and maintaining the minimum coverage afforded by the RIN
replacement mechanism at all times.
(3) RINs held by the RIN replacement mechanism (if any) must be
identified in a unique EMTS account designated for the exclusive use of
the replacement mechanism.
(4) Distribution and removal of RINs from the replacement mechanism
may not be under the sole operational control of the third-party
auditor.
(5) An originally signed duplicate of the agreement or contract
establishing the RIN replacement mechanism must be submitted to the EPA
by the independent third party auditor in accordance with Sec.
80.1450(g)(7).
(6) Any substantive change to the agreement establishing the RIN
replacement mechanism must be submitted to the EPA within 30 days of the
change.
(c) Cap on RIN replacement for independent third party auditors of
A-RINs. (1) If required to replace invalid A-RINs pursuant to paragraph
(b) of this section, the independent third party auditor shall be
required to replace no more than the percentage specified in
[[Page 253]]
paragraph (c)(2) of this section of each D code of A-RINs verified by
the auditor in the current calendar year and four previous calendar
years.
(2) The cap on RIN replacement for auditors of A-RINs shall be two
percent for A-RINs generated in the interim period.
(3) The auditor's potential replacement responsibility for a given
RIN will expire at the end of the fourth calendar year after the
calendar year in which the RIN was verified.
(d) Applicability of the RIN replacement cap. The cap on RIN
replacement does not apply when invalid verified RINs are a result of
auditor error, omission, negligence, fraud, collusion with the renewable
fuel producer, or a failure to implement the QAP properly or fully.
[79 FR 42121, July 18, 2014]
Sec. 80.1471 Requirements for QAP auditors.
(a) QAP audits conducted pursuant to Sec. 80.1472 must be conducted
by an independent third-party auditor.
(b) To be considered an independent third-party auditor under
paragraph (a) of this section, all the following conditions must be met:
(1) The independent third-party auditor and its contractors and
subcontractors must not be owned or operated by the audited party or any
subsidiary or employee of the audited party.
(2) The independent third-party auditor and its contractors and
subcontractors shall not be owned or operated by an obligated party or
any subsidiary or employee of an obligated party.
(3) The independent third-party auditor shall not own, buy, sell, or
otherwise trade RINs unless required to maintain a financial assurance
mechanism for a QAP implemented under QAP Option A pursuant to Sec.
80.1469(a) during the interim period or to replace an invalid RIN
pursuant to Sec. 80.1474.
(4) The independent third-party auditor and its contractors and
subcontractors must be free from any interest or the appearance of any
interest in the audited party's business.
(5) The audited party must be free from any interest or the
appearance of any interest in the third-party auditor's business and the
businesses of third-party auditor's contractors and subcontractors.
(6) The independent third-party auditor and its contractors and
subcontractors must not have performed an attest engagement under Sec.
80.1464(b) for the audited party for the same compliance period as a QAP
audit conducted pursuant to Sec. 80.1472.
(7) The independent third-party auditor and its contractors and
subcontractors must not be debarred, suspended, or proposed for
debarment pursuant to the Government-wide Debarment and Suspension
regulations, 40 CFR part 32, or the Debarment, Suspension and
Ineligibility provisions of the Federal Acquisition Regulations, 48 CFR
part 9, subpart 9.4.
(8) The independent third-party auditor and its contractors and
subcontractors must act impartially when performing all activities under
this section.
(9) The independent third-party auditor and its contractors and
subcontractors must be free from any interest in the audited party's
business and receive no financial benefit from the outcome of auditing
service, apart from payment for the auditing services.
(10) The independent third-party auditor and its contractors and
subcontractors must not have been involved in the design or construction
of the audited facility.
(11) The independent third-party auditor and its contractors and
subcontractors must ensure that all personnel involved in the third-
party audit (including the verification activities) under this section
are not negotiating for future employment with the owner or operator of
the audited party. At a minimum, prior to conducting the audit, the
independent third-party auditor must obtain an attestation (or similar
document) from each person involved in the audit stating that they are
not negotiating for future employment with the owner or operator of the
audited party.
(12) The independent third-party auditor and its contractors and
subcontractors must have written policies and procedures to ensure that
the independent third-party auditor and all personnel under the
independent third-party auditor's direction or supervision
[[Page 254]]
comply with the competency, independence, and impartiality requirements
of this section.
(c) Independent third-party auditors must maintain professional
liability insurance. Independent third-party auditors must use insurance
providers that possess a financial strength rating in the top four
categories from Standard & Poor's or Moody's (i.e., AAA, AA, A, or BBB
for Standard & Poor's and Aaa, Aa, A, or Baa for Moody's), or a
comparable rating acceptable to EPA. Independent third-party auditors
must disclose the level of professional liability insurance they possess
when entering into contracts to provide RIN verification services.
(d)(1) In the event that an independent third-party auditor
identifies a RIN that may have been invalidly generated, the independent
third-party auditor shall, within five business days, send notification
of the potentially invalidly generated RIN to the EPA and the renewable
fuel producer that generated the RIN.
(2) The independent third-party auditor shall provide the
notification required under paragraph (d)(1) of this section in writing
(which includes email or facsimile) and, if requested by the party being
notified of a potentially invalidly generated RIN, by telephone.
(e) The independent third-party auditor shall identify RINs
generated from a renewable fuel producer or foreign renewable fuel
producer as having been verified under a QAP.
(1) For RINs verified under QAP Option A pursuant to Sec.
80.1469(a) during the interim period, RINs shall be designated as A-
RINs.
(2) For RINs verified under QAP Option B pursuant to Sec.
80.1469(b), during the interim period, RINs shall be designated as B-
RINs.
(3) For RINs verified under a QAP pursuant to Sec. 80.1469(c), RINs
shall be designated as Q-RINs and shall be identified as having been
verified under a QAP in EMTS.
(4) The independent third-party auditor shall not identify RINs
generated from a renewable fuel producer or foreign renewable fuel
producer as having been verified under a QAP if a revised QAP must be
submitted to and approved by the EPA under Sec. 80.1469(f).
(5) The independent third-party auditor must not identify RINs
generated for renewable fuel produced using a biointermediate as having
been verified under a QAP unless the biointermediate used to produce the
renewable fuel was verified under an approved QAP pursuant to Sec.
80.1477.
(f)(1) Except as specified in paragraph (f)(2) of this section,
auditors may only verify RINs that have been generated after the audit
required under Sec. 80.1472 has been completed. Auditors may only
verify biointermediates that were produced after the audit required
under Sec. 80.1472 has been completed. Auditors must only verify RINs
generated from renewable fuels produced from biointermediates after the
audit required under Sec. 80.1472 has been completed for both the
biointermediate production facility and the renewable fuel production
facility.
(i) For A-RINs, ongoing monitoring must have been initiated.
(ii) Verification of RINs or biointermediates may continue for no
more than 200 days following an on-site visit or 380 days after an on-
site visit if a previously the EPA-approved remote monitoring system is
in place at the renewable fuel production facility.
(2) Auditors may verify RINs that were generated before the audit
required under Sec. 80.1472 has been completed, under the following
conditions:
(i) The RINs in question were generated during the interim period.
(ii) The audit is completed during the interim period.
(iii) The audit is performed in accordance with the elements
specified in a QAP that has been approved by the EPA per Sec.
80.1469(e).
(iv) The audit requirements of Sec. 80.1472 are met for every batch
of renewable fuel for which RINs were generated and are being verified.
(v) The auditor may not perform more than one audit under this
subparagraph for any single RIN generator.
(g) The independent third-party auditor must permit any
representative of the EPA to monitor at any time the implementation of
QAPs and renewable
[[Page 255]]
fuel and biointermediate production facility audits.
(h) Any person who fails to meet a requirement under of this section
shall be subject to a separate violation pursuant to Sec. 80.1460(f).
[79 FR 42122, July 18, 2014, as amended at 80 FR 9098, Feb. 19, 2015; 87
FR 39674, July 1, 2022; 88 FR 44592, July 12, 2023]
Sec. 80.1472 Requirements for quality assurance audits.
(a) General requirements. (1) An audit shall be performed by an
auditor who meets the requirements of Sec. 80.1471.
(2) An audit shall be based on either an Option A QAP per Sec.
80.1469(a) during the interim period, an Option B QAP per Sec.
80.1469(b) during the interim period, or a QAP per Sec. 80.1469(c).
(3) Each audit shall verify every element contained in an applicable
and approved QAP.
(4) Each audit shall include a review of documents generated by the
renewable fuel producer or biointermediate producer.
(b) On-site visits--(1) Option A QAP during the interim period. (i)
The auditor shall conduct an on-site visit at the renewable fuel
production facility at least 4 times per calendar year.
(ii) The on-site visits specified in paragraph (b)(1)(i) of this
section shall occur at least 60 days apart. The 60-day period shall
start the day after the previous on-site ends.
(iii) The on-site visit shall include verification of all QAP
elements that require inspection or evaluation of the physical
attributes of the renewable fuel production facility, except for any
physical attribute that is verified through remote monitoring equipment
per the applicable QAP.
(2) Option B QAP during the interim period. (i) The auditor shall
conduct an on-site visit at the renewable fuel production facility at
least 4 times per calendar year.
(ii) The on-site visits specified in paragraph (b)(2)(i) of this
section shall occur at least 60 days apart. The 60-day period shall
start the day after the previous on-site ends.
(iii) The on-site visit shall include verification of all QAP
elements that require inspection or evaluation of the physical
attributes of the renewable fuel production facility.
(3) QAP. (i) As applicable, the independent third-party auditor
shall conduct an on-site visit at the renewable fuel production
facility, foreign ethanol production facility, or biointermediate
production facility:
(A) At least two times per calendar year; or
(B) In the event an auditor uses a remote monitoring system approved
by the EPA, at least one time per calendar year.
(ii) An on-site visit specified in paragraph (b)(3)(i) of this
section shall occur no more than:
(A) 200 days after the previous on-site visit. The 200-day period
shall start the day after the previous on-site visit ends; or
(B) 380 days after the previous on-site visit if a previously
approved (by EPA) remote monitoring system is in place at the renewable
fuel production facility, foreign ethanol production facility, or
biointermediate production facility, as applicable. The 380-day period
shall start the day after the previous on-site visit ends.
(iii) An on-site visit shall include verification of all QAP
elements that require inspection or evaluation of the physical
attributes of the renewable fuel production facility, foreign ethanol
production facility, or biointermediate production facility, as
applicable.
(iv) The on-site visit shall be overseen by a professional engineer,
as specified in Sec. 80.1450(b)(2)(i)(A) and (b)(2)(i)(B).
[79 FR 42122, July 18, 2014, as amended at 85 FR 7083, Feb. 6, 2020; 87
FR 39674, July 1, 2022]
Sec. 80.1473 Affirmative defenses.
(a) Criteria. Any person who engages in actions that would be a
violation of the provisions of either Sec. 80.1460(b)(2) or (c)(1),
other than the generator of an invalid RIN, will not be deemed in
violation if the person demonstrates that the criteria under paragraphs
(c), (d), or (e) of this section are met.
(b) Applicability of affirmative defenses. The following provisions
apply to affirmative defenses asserted under paragraph (a) of this
section:
[[Page 256]]
(1) Affirmative defenses only apply to RINs that were invalidly
generated and verified through a quality assurance audit using an EPA-
approved QAP.
(2) Affirmative defenses only apply in situations where an invalidly
generated verified RIN is either transferred to another person
(violation of Sec. 80.1460(b)(2)) or used for compliance for an
obligated party's RVO (use violation of Sec. 80.1460(c)(1)).
(3) Affirmative defenses do not apply to the generator of an invalid
RIN.
(c) Asserting an affirmative defense for invalid A-RINs verified
during the interim period. To establish an affirmative defense to a
violation of Sec. 80.1460(b)(2) or (c)(1) involving invalid A-RINs, the
person must meet the notification requirements of paragraph (f) of this
section and prove by a preponderance of evidence all of the following:
(1) The RIN in question was verified through a quality assurance
audit pursuant to Sec. 80.1472 using an approved Option A QAP as
specified in Sec. 80.1469(a).
(2) The person did not know or have reason to know that the RINs
were invalidly generated prior to being verified by the independent
third-party auditor.
(3) If the person self-identified the RIN as having been invalidly
generated, the person notified the EPA within five business days of
discovering the invalidity.
(4) The person did not cause the invalidity.
(5) The person did not have a financial interest in the company that
generated the invalid RIN.
(d) Asserting an affirmative defense for invalid B-RINs verified
during the interim period. To establish an affirmative defense to a
violation of Sec. 80.1460(b)(2) or (c)(1) involving invalid B-RINs, the
person must meet the notification requirements of paragraph (f) of this
section and prove by a preponderance of evidence all of the following:
(1) The RIN in question was verified through a quality assurance
audit pursuant to Sec. 80.1472 using an approved Option B QAP as
specified in Sec. 80.1469(b).
(2) The person did not know or have reason to know that the RINs
were invalidly generated at the time of transfer or use for compliance,
unless the RIN generator replaced the RIN pursuant to Sec. 80.1474.
(3) If the person self-identified the RIN as having been invalidly
generated, the person notified the EPA within five business days of
discovering the invalidity.
(4) The person did not cause the invalidity.
(5) The person did not have a financial interest in the company that
generated the invalid RIN.
(6) If the person used the invalid B-RIN for compliance, the person
adjusted its records, reports, and compliance calculations in which the
invalid B-RIN was used as required by Sec. 80.1431, unless the RIN
generator replaced the RIN pursuant to Sec. 80.1474.
(e) Asserting an affirmative defense for invalid Q-RINs. To
establish an affirmative defense to a violation of Sec. 80.1460(b)(2)
or (c)(1) involving invalid Q-RINs, the person must meet the
notification requirements of paragraph (f) of this section and prove by
a preponderance of evidence all of the following:
(1) The RIN in question was verified through a quality assurance
audit pursuant to Sec. 80.1472 using an approved QAP as specified in
Sec. 80.1469(c).
(2) The person did not know or have reason to know that the RINs
were invalidly generated at the time of transfer or use for compliance,
unless the RIN generator replaced the RIN pursuant to Sec. 80.1474.
(3) If the person self-identified the RIN as having been invalidly
generated, the person notified the EPA within five business days of
discovering the invalidity.
(4) The person did not cause the invalidity.
(5) The person did not have a financial interest in the company that
generated the invalid RIN.
(6) If the person used the invalid Q-RIN for compliance, the person
adjusted its records, reports, and compliance calculations in which the
invalid Q-RIN was used as required by Sec. 80.1431, unless the RIN
generator replaced the RIN pursuant to Sec. 80.1474.
(f) Notification requirements. A person asserting an affirmative
defense to a
[[Page 257]]
violation of Sec. 80.1460(b)(2) or (c)(1), arising from the transfer or
use of an invalid A-RIN, B-RIN, or Q-RIN must submit a written report to
the EPA via the EMTS support line ([email protected]),
including all pertinent supporting documentation, demonstrating that the
requirements of paragraphs (c), (d), or (e) of this section were met.
The written report must be submitted within 30 days of the person
discovering the invalidity.
[79 FR 42123, July 18, 2014, as amended at 87 FR 39674, July 1, 2022; 88
FR 44592, July 12, 2023]
Sec. 80.1474 Replacement requirements for invalidly generated RINs.
(a) Responsibility for replacement of invalid verified RINs. (1) The
generator of the A-RIN and the independent third-party auditor that
verified the A-RIN are required to replace invalidly generated A-RINs
with valid RINs pursuant to the procedures specified in paragraph (b) of
this section.
(2) The generator of the B-RIN and the obligated party that owns the
B-RIN are required to replace invalidly generated B-RINs with valid RINs
pursuant to the procedures specified in paragraph (b) of this section.
(3) The generator of the Q-RIN and the obligated party that owns the
Q-RIN are required to replace invalidly generated Q-RINs with valid RINs
pursuant to the procedures specified in paragraph (b) of this section.
(4) The generator of an unverified RIN and the obligated party that
owns an unverified RIN are required to replace invalidly generated and
unverified RINs pursuant to the procedures specified in paragraph (b) of
this section.
(b) Identification and treatment of potentially invalid RINs (PIRs).
(1) Any RIN can be identified as a PIR by the RIN generator, an
independent third-party auditor that verified the RIN, or the EPA.
(2) For PIRs identified by the RIN generator, the generator is
required to notify the EPA via the EMTS support line
([email protected]) within five business days of the
identification, including an initial explanation of why the RIN is
believed to be invalid, and is required to take any of the following
corrective actions within 30 days:
(i) Retire the PIR.
(ii) Retire a valid RIN meeting the requirements of paragraph (d) of
this section.
(3) For PIRs identified by the independent third-party auditor that
verified the RIN, the independent third-party auditor is required to
notify the EPA via the EMTS support line ([email protected])
and the RIN generator in writing within five business days of the
identification, including an initial explanation of why the RIN is
believed to be invalid.
(4) Within 30 days of being notified by the EPA or the independent
third-party auditor that verified the RIN that a RIN is a PIR, the RIN
generator is required to take one of the following actions:
(i) In the event that the EPA identifies a RIN as a PIR, do one of
the following:
(A) Retire the PIR.
(B) Retire a valid RIN following the requirements of paragraph (d)
of this section.
(C) Submit a demonstration in writing to the EPA via the EMTS
support line ([email protected]) that the PIR is valid.
(1) If the EPA determines that the demonstration is satisfactory,
the RIN will no longer be considered a PIR.
(2) If the EPA determines that the demonstration is not
satisfactory, the PIR will be deemed invalid and the PIR generator must
retire the PIR or a valid RIN following the requirements of paragraph
(d) of this section within 30 days of notification by the EPA.
(ii) In the event that the independent third-party auditor
identifies a RIN as a PIR, do one of the following:
(A) Retire the PIR.
(B) Retire a valid RIN following the requirements of paragraph (d)
of this section.
(C) Submit a demonstration in writing to the independent third-party
auditor and the EPA via the EMTS support line
([email protected]) that the PIR is valid.
[[Page 258]]
(1) If the independent third-party auditor determines that the
demonstration is satisfactory, the PIR will be deemed to be a valid RIN;
however, the EPA reserves the right to make a determination regarding
the validity of the RIN.
(2) If the independent third-party auditor determines that the
demonstration is not satisfactory, the EPA will then make a
determination whether the demonstration is not satisfactory, and if so,
the PIR will be deemed invalid and the PIR generator must retire the PIR
or a valid RIN following the requirements of paragraph (d) of this
section within 30 days of notification by the EPA.
(5) Within 60 days of receiving a notification from the EPA that a
PIR generator has failed to perform a corrective action required
pursuant to this section:
(i) For A-RINs, the independent third-party auditor that verified
the PIR is required to retire valid RINs meeting the requirements of
paragraph (d) of this section.
(ii) For Q-RINs, B-RINs, and unverified RINs, the party that owns
the invalid RIN is required to do one of the following:
(A) Retire the invalid RIN.
(B) If the invalid RIN has already been used for compliance with an
obligated party's RVO, correct the RVO to subtract the invalid RIN.
(c) Failure to take corrective action. Any person who fails to meet
a requirement under paragraph (b)(4) or (b)(5) of this section shall be
liable for full performance of such requirement, and each day of non-
compliance shall be deemed a separate violation pursuant to Sec.
80.1460(f). The administrative process for replacement of invalid RINs
does not, in any way, limit the ability of the United States to exercise
any other authority to bring an enforcement action under section 211 of
the Clean Air Act, the fuels regulations at 40 CFR part 80, or any other
applicable law.
(d) The following specifications apply when retiring valid RINs to
replace PIRs or invalid RINs:
(1) When a RIN is retired to replace a PIR or invalid RIN, the D
code of the retired RIN must be eligible to be used towards meeting all
the renewable volume obligations as the PIR or invalid RIN it is
replacing, as specified in Sec. 80.1427(a)(2).
(2) The number of RINs retired must be equal to the number of PIRs
or invalid RINs being replaced, subject to paragraph (e) or (f) of this
section if applicable, and Sec. 80.1470(c).
(e) Limited exemption for invalid B-RINs verified during the interim
period. (1) In the event that an obligated party is required to retire
or replace an invalid RIN that is a B-RIN pursuant to paragraph (b) of
this section, the obligated party will be afforded a ``limited
exemption'' (LE) equal to two percent of its annual Renewable Volume
Obligation (RVO) for calendar years 2013 and 2014 during the interim
period.
(2) Limited exemptions are calculated as follows:
LECB,i = 0.02 x RVOCB,i
LEBBD,i = 0.02 x RVOBBD,i
LEAB,i = 0.02 x RVOAB,i
LERF,i = 0.02 x RVORF,i
Where:
LECB,i = Limited exemption for cellulosic biofuel for year i.
LEBBD,i = Limited exemption for biomass-based diesel for year
i.
LEAB,i = Limited exemption for advanced biofuel for year i.
LERF,i = Limited exemption for renewable for year i.
RVOCB,i = The Renewable Volume Obligation for cellulosic
biofuel for the obligated party for calendar year i, in
gallons, pursuant to Sec. 80.1407.
RVOBBD,i = The Renewable Volume Obligation for biomass-based
diesel for the obligated party for calendar year i after 2010,
in gallons, pursuant to Sec. 80.1407.
RVOAB,i = The Renewable Volume Obligation for advanced
biofuel for the obligated party for calendar year i, in
gallons, pursuant to Sec. 80.1407.
RVORF,i = The Renewable Volume Obligation for renewable fuel
for the obligated party for calendar year i, in gallons,
pursuant to Sec. 80.1407.
(3) If the number of invalidly generated B-RINs required to be
retired or replaced in a calendar year is less than or equal to LE as
calculated in paragraph (d)(2) of this section, the entire RIN
retirement obligation is excused.
(4) If the number of invalidly generated B-RINs required to be
retired or replaced in a calendar year is greater than LE as calculated
in paragraph
[[Page 259]]
(d)(2) of this section, the retirement of a number of B-RINs equal to
two percent of the obligated party's RVO is excused.
(5) The limited exemption for B-RINs applies only in calendar years
2013 and 2014 during the interim period.
(f) Limited exemption for invalid Q-RINs. (1) In the event that an
obligated party is required to retire or replace an invalid RIN that is
a Q-RIN pursuant to paragraph (b) of this section, the obligated party
will be afforded a ``limited exemption'' (LE) equal to two percent of
its annual Renewable Volume Obligation (RVO) for calendar years 2014,
2015, and 2016.
(2) Limited exemptions are calculated as follows:
LECB,i = 0.02 x RVOCB,i
LEBBD,i = 0.02 x RVOBBD,i
LEAB,i = 0.02 x RVOAB,i
LERF,i = 0.02 x RVORF,i
Where:
LECB,i = Limited exemption for cellulosic biofuel for year i.
LEBBD,i = Limited exemption for biomass-based diesel for year
i.
LEAB,i = Limited exemption for advanced biofuel for year i.
LERF,i = Limited exemption for renewable for year i.
RVOCB,i = The Renewable Volume Obligation for cellulosic
biofuel for the obligated party for calendar year i, in
gallons, pursuant to Sec. 80.1407.
RVOBBD,i = The Renewable Volume Obligation for biomass-based
diesel for the obligated party for calendar year i after 2010,
in gallons, pursuant to Sec. 80.1407.
RVOAB,i = The Renewable Volume Obligation for advanced
biofuel for the obligated party for calendar year i, in
gallons, pursuant to Sec. 80.1407.
RVORF,i = The Renewable Volume Obligation for renewable fuel
for the obligated party for calendar year i, in gallons,
pursuant to Sec. 80.1407.
(3) If the number of invalidly generated Q-RINs required to be
retired or replaced in a calendar year is less than or equal to LE as
calculated in paragraph (d)(2) of this section, the entire RIN
retirement obligation is excused.
(4) If the number of invalidly generated Q-RINs required to be
retired or replaced in a calendar year is greater than LE as calculated
in paragraph (d)(2) of this section, the retirement of a number of Q-
RINs equal to two percent of the obligated party's RVO is excused.
(5) The limited exemption for Q-RINs applies only in calendar years
2014, 2015, and 2016.
(g) All parties who retire RINs under this section shall use the
forms and follow the procedures prescribed by EPA.
[79 FR 42123, July 18, 2014, as amended at 87 FR 39674, July 1, 2022; 88
FR 44592, July 12, 2023]
Sec. 80.1475 What are the additional attest engagement requirements
for parties that redesignate certified NTDF as MVNRLM diesel fuel?
(a) General requirements. (1) In addition to the attest engagement
requirements under Sec. 80.1464, all obligated parties required to
arrange for additional attest engagement procedures under Sec.
80.1464(a)(1)(vii) must have an annual attest engagement conducted by an
auditor using the minimum attest procedures specified in this section.
(2) All applicable requirements and procedures outlined in 40 CFR
1090.1800 through 1090.1850 apply to the auditors and attest engagement
procedures specified in this section.
(3) Obligated parties must include any additional information
required under this section in the attest engagement report under Sec.
80.1464(d).
(4) Report as a finding if the party failed to either incur or
satisfy an RVO if required.
(b) EPA reports. Auditors must perform the following:
(1) Obtain and read a copy of the obligated party's reports filed
with EPA as required by Sec. 80.1451(a)(1)(xix) for the reporting
period.
(2) In the case of an obligated party's report to EPA that
represents aggregate calculations for more than one facility, obtain the
facility-specific volume and property information that was used by the
refiner to prepare the aggregate report. Foot and crossfoot the
facility-specific totals and agree to the values in the aggregate
report. The procedures in paragraphs (b) and (c) of this section are
then performed separately for each facility.
(3) Obtain a written representation from a company representative
that
[[Page 260]]
the report copies are complete and accurate copies of the reports filed
with EPA.
(4) Identify, and report as a finding, the name of the commercial
computer program used by the refiner or importer to track the data
required by the regulations in this part, if any.
(c) Inventory reconciliation analysis. Auditors must perform the
following:
(1) Obtain an inventory reconciliation analysis for the facility for
the reporting period for each of the following and perform the
procedures at paragraphs (c)(2) through (4) of this section separately
for each of the following products:
(i) The volume of certified NTDF that was redesignated as MVNRLM
diesel fuel.
(ii) The volume of MVNRLM diesel fuel that was redesignated to a
non-transportation use.
(iii) The volume of MVNRLM diesel fuel owned when the fuel was
received at the facility and acquired at the facility during the
compliance period.
(iv) The volume of MVNRLM diesel fuel owned and sold or transferred
to other parties at the facility during the compliance period.
(v) The volume of certified NTDF received.
(vi) The volume of certified NTDF delivered.
(2) Foot and crossfoot the volume totals reflected in the analysis.
(3) Agree the beginning and ending inventory amounts in the analysis
to the facility's inventory records.
(4) If the obligated party delivered more MVNRLM diesel fuel than
received, agree the annual balance with the reports obtained at Sec.
80.1475(b)(1) and verify whether the obligated party incurred and
satisfied its RVO under Sec. 80.1408(a)(2)(i).
(5) Report as a finding each of the volume totals along with any
discrepancies.
(d) Listing of tenders. Auditors must perform the following:
(1) For each of the volumes listed in paragraphs (c)(1)(iii) through
(vi) of this section, obtain a separate listing of all tenders from the
refiner or importer for the reporting period. Each listing should
provide for each tender the volume shipped and other information as
needed to distinguish tenders.
(2) Foot to the volume totals per the listings.
(3) Agree the volume totals on the listing to the tender volume
total in the inventory reconciliation analysis obtained in paragraph (c)
of this section.
(4) For each of the listings select a representative sample of the
tenders in accordance with the guidelines in 40 CFR 1090.1805, and for
each tender selected perform the following:
(i) Obtain product transfer documents associated with the tender and
agree the volume on the tender listing to the volume on the product
transfer documents.
(ii) Note whether the product transfer documents include the
information required by 40 CFR 1090.1115 and, for tenders involving the
transfer of certified NTDF, the information required by Sec.
80.1453(e).
(5) Report as a finding any discrepancies.
[85 FR 7083, Feb. 6, 2020, as amended at 85 FR 78468, Dec. 4, 2020; 87
FR 39674, July 1, 2022]
Sec. 80.1476 Requirements for biointermediate producers.
Biointermediate producers must comply with the following
requirements:
(a) Registration. No later than 60 days prior to the transfer of any
biointermediate to be used in the production of a renewable fuel for
which RINs may be generated, biointermediate producers must register
with EPA pursuant to the requirements of Sec. 80.1450(b).
(b) Reporting. Biointermediate producers must comply with the
reporting requirements in Sec. 80.1451(j).
(c) Recordkeeping. Biointermediate producers must comply with the
recordkeeping requirements in Sec. 80.1454(i).
(d) PTDs. Biointermediate producers must comply with the PTD
requirements in Sec. 80.1453(f).
(e) Quality Assurance Plans. Prior to the transfer of any
biointermediate to be used in the production of a renewable fuel for
which RINs may be generated, biointermediate producers must have an
approved quality assurance plan pursuant to Sec. 80.1477(b) and the
independent third-party auditor
[[Page 261]]
must have conducted a site visit of the biointermediate production
facility under Sec. 80.1472.
(f) Attest engagements. Biointermediate producers must comply with
the annual attest engagement requirements in Sec. 80.1464(h).
(g) Limitations on biointermediate transfers and production. (1) A
biointermediate producer must transfer all biointermediates produced
from a single biointermediate facility to a single renewable fuel
production facility as designated under Sec. 80.1450(b)(1)(ii)(B)(1).
(2)(i) Except as specified in paragraph (g)(2)(ii) of this section,
a batch of biointermediate must be segregated from other batches of
biointermediate (even if it is the same type of biointermediate), other
feedstocks, foreign ethanol, and renewable fuels from the point that the
batch of biointermediate is produced to the point where the batch of
biointermediate is received at the renewable fuel production facility
designated under Sec. 80.1450(b)(1)(ii)(B)(1).
(ii)(A) Batches of biointermediate may be commingled between the
biointermediate production facility and the designated renewable fuel
production facility as long as each batch is produced at the same
biointermediate production facility, is the same type of
biointermediate, and no other feedstocks, biointermediates, foreign
ethanol, or renewable fuels are comingled.
(B) A renewable fuel producer may commingle batches of
biointermediate at an off-site storage tank if all the following
conditions are met:
(1) Only batches of the same type of biointermediate are commingled
and no other feedstocks, biointermediates, foreign ethanol, or renewable
fuels are comingled in the off-site storage tank.
(2) The renewable fuel producer owns or is the sole position holder
in the off-site storage tank.
(3) Renewable fuel producers that receive biointermediate at a
renewable fuel production facility may not be a biointermediate
producer.
(4) A biointermediate must not be used to make another
biointermediate.
(5) A foreign biointermediate producer must not transfer
biointermediate to a non-RIN-generating foreign producer.
(h) Batch numbers and volumes. (1) Each batch of biointermediate
produced at a biointermediate production facility must be assigned a
number (the ``batch number''), consisting of the EPA-assigned company
registration number, the EPA-assigned facility registration number, the
last two digits of the year in which the batch was produced, and a
unique number for the batch, beginning with the number one for the first
batch produced each calendar year and each subsequent batch during the
calendar year being assigned the next sequential number (e.g., 4321-
54321-95-000001, 4321-54321-95-000002, etc.).
(2) For biointermediates measured on a volume basis, the volume of
each batch of biointermediate must be adjusted to a standard temperature
of 60 [deg]F as specified in Sec. 80.1426(f)(8).
(i) Designation. Each batch of biointermediate produced at a
biointermediate production facility must be designated for use in the
production of a renewable fuel in accordance with the biointermediate
producer's registration under Sec. 80.1450. The designation for the
batch of biointermediate must be clearly indicated on PTDs for the
biointermediate as described in Sec. 80.1453(f)(1)(vi). The same batch
or a portion of a batch may not be designated as both a biointermediate
and a renewable fuel.
[87 FR 39675, July 1, 2022]
Sec. 80.1477 Requirements for QAPs for biointermediate producers.
(a) Independent third-party auditors that verify biointermediate
production must meet the requirements of Sec. 80.1471(a) through (c)
and (f) through (h), as applicable.
(b) QAPs approved by EPA to verify biointermediate production must
meet the requirements in Sec. 80.1469(c) through (f), as applicable.
(c) Quality assurance audits, when performed, must be conducted in
accordance with the requirements in Sec. 80.1472(a) and (b)(3).
(d)(1) If an independent third-party auditor identifies a
potentially improperly produced biointermediate, the independent third-
party auditor must notify EPA, the biointermediate producer, and the
renewable fuel producer
[[Page 262]]
that may have been transferred the biointermediate within five business
days of the identification, including an initial explanation of why the
biointermediate may have been improperly produced.
(2) If RINs were generated from the potentially improperly produced
biointermediate, the RIN generator must follow the applicable
identification and treatment of PIRs as specified in Sec. 80.1474.
(e) For the generation of Q-RINs for renewable fuels that were
produced from a biointermediate, the biointermediate must be verified
under an approved QAP as described in paragraph (b) of this section and
the RIN generating facility must be verified under an approved QAP as
described in Sec. 80.1469.
[87 FR 39675, July 1, 2022]
Sec. 80.1478 Requirements for foreign biointermediate producers and
importers.
(a) Foreign biointermediate producer. For purposes of this subpart,
a foreign biointermediate producer is a person located outside the
United States, the Commonwealth of Puerto Rico, the Virgin Islands,
Guam, American Samoa, and the Commonwealth of the Northern Mariana
Islands (collectively referred to in this section as ``the United
States'') that has been approved by EPA to produce biointermediate for
use in the production of renewable fuel by a RIN-generating renewable
fuel producer.
(b) Foreign biointermediate producer requirements. Any foreign
biointermediate producer must meet all requirements that apply to
biointermediate producers under this subpart as a condition of being
approved as a foreign biointermediate producer under this subpart.
(c) Foreign biointermediate producer commitments. Any foreign
biointermediate producer must commit to the following provisions as a
condition of being registered as a foreign biointermediate producer
under this subpart:
(1) Any EPA inspector or auditor must be given full, complete, and
immediate access to conduct inspections and audits of the foreign
biointermediate producer facility.
(i) Inspections and audits may be either announced in advance by
EPA, or unannounced.
(ii) Access will be provided to any location where:
(A) Biointermediate is produced.
(B) Documents related to foreign biointermediate producer operations
are kept.
(C) Biointermediate is stored or transported between the foreign
biointermediate producer and the renewable fuel producer, including
storage tanks, vessels, and pipelines.
(iii) EPA inspectors and auditors may be EPA employees or
contractors to EPA.
(iv) Any documents requested that are related to matters covered by
inspections and audits must be provided to an EPA inspector or auditor
on request.
(v) Inspections and audits may include review and copying of any
documents related to the following:
(A) The volume of biointermediate produced or delivered to renewable
fuel production facilities.
(B) Transfers of title or custody to the biointermediate.
(C) Work performed and reports prepared by independent third parties
and by independent auditors under the requirements of this section,
including work papers.
(vi) Inspections and audits by EPA may include interviewing
employees.
(vii) Any employee of the foreign biointermediate producer must be
made available for interview by the EPA inspector or auditor, on
request, within a reasonable time period.
(viii) English language translations of any documents must be
provided to an EPA inspector or auditor, on request, within 10 business
days.
(ix) English language interpreters must be provided to accompany EPA
inspectors and auditors, on request.
(2) An agent for service of process located in the District of
Columbia must be named, and service on this agent constitutes service on
the foreign biointermediate producer or any employee of the foreign
biointermediate producer for any action by EPA or otherwise by the
United States related to the requirements of this subpart.
[[Page 263]]
(3) The forum for any civil or criminal enforcement action related
to the provisions of this section for violations of the Clean Air Act or
regulations in this title promulgated thereunder must be governed by the
Clean Air Act, including the EPA administrative forum where allowed
under the Clean Air Act.
(4) United States substantive and procedural laws apply to any civil
or criminal enforcement action against the foreign biointermediate
producer or any employee of the foreign biointermediate producer related
to the provisions of this section.
(5) Applying to be an approved foreign biointermediate producer
under this section, or producing or exporting biointermediate under such
approval, and all other actions to comply with the requirements of this
subpart relating to such approval constitute actions or activities
covered by and within the meaning of the provisions of 28 U.S.C.
1605(a)(2), but solely with respect to actions instituted against the
foreign biointermediate producer, its agents and employees in any court
or other tribunal in the United States for conduct that violates the
requirements applicable to the foreign biointermediate producer under
this subpart, including conduct that violates the False Statements
Accountability Act of 1996 (18 U.S.C. 1001) and section 113(c)(2) of the
Clean Air Act (42 U.S.C. 7413).
(6) The foreign biointermediate producer, or its agents or
employees, will not seek to detain or to impose civil or criminal
remedies against EPA inspectors or auditors for actions performed within
the scope of EPA employment or contract related to the provisions of
this section.
(7) The commitment required by this paragraph (c) must be signed by
the owner or president of the foreign biointermediate producer company.
(8) In any case where the biointermediate produced at a foreign
biointermediate production facility is stored or transported by another
company between the production facility and the vessel that transports
the biointermediate to the United States, the foreign biointermediate
producer must obtain from each such other company a commitment that
meets the requirements specified in paragraphs (c)(1) through (7) of
this section, and these commitments must be included in the foreign
biointermediate producer's application to be an approved foreign
biointermediate producer under this subpart.
(d) Sovereign immunity. By submitting an application to be an
approved foreign biointermediate producer under this subpart, or by
producing and exporting biointermediate fuel to the United States under
such approval, the foreign biointermediate producer, and its agents and
employees, without exception, become subject to the full operation of
the administrative and judicial enforcement powers and provisions of the
United States without limitation based on sovereign immunity, with
respect to actions instituted against the foreign biointermediate
producer, its agents and employees in any court or other tribunal in the
United States for conduct that violates the requirements applicable to
the foreign biointermediate producer under this subpart, including
conduct that violates the False Statements Accountability Act of 1996
(18 U.S.C. 1001) and section 113(c)(2) of the Clean Air Act (42 U.S.C.
7413).
(e) English language reports. Any document submitted to EPA by a
foreign biointermediate producer must be in English or must include an
English language translation.
(f) Withdrawal or suspension of foreign biointermediate producer
approval. EPA may withdraw or suspend a foreign biointermediate
producer's approval where any of the following occur:
(1) A foreign biointermediate producer fails to meet any requirement
of this section.
(2) A foreign government fails to allow EPA inspections or audits as
provided in paragraph (c)(1) of this section.
(3) A foreign biointermediate producer asserts a claim of, or a
right to claim, sovereign immunity in an action to enforce the
requirements in this subpart.
(g) Additional requirements for applications, reports, and
certificates. Any application for approval as a foreign biointermediate
producer, any report, certification, or other submission required under
this section shall be:
[[Page 264]]
(1) Submitted in accordance with procedures specified by EPA,
including use of any forms that may be specified by EPA.
(2) Signed by the president or owner of the foreign biointermediate
producer company, or by that person's immediate designee, and must
contain the following declarations:
(i) Certification.
``I hereby certify:
That I have actual authority to sign on behalf of and to bind [NAME
OF FOREIGN BIOINTERMEDIATE PRODUCER] with regard to all statements
contained herein;
That I am aware that the information contained herein is being
Certified, or submitted to the United States Environmental Protection
Agency, under the requirements of 40 CFR part 80, subpart M, and that
the information is material for determining compliance under these
regulations; and
That I have read and understand the information being Certified or
submitted, and this information is true, complete and correct to the
best of my knowledge and belief after I have taken reasonable and
appropriate steps to verify the accuracy thereof.''
(ii) Affirmation.
``I affirm that I have read and understand the provisions of 40 CFR
part 80, subpart M, including 40 CFR 80.1478 apply to [NAME OF FOREIGN
BIOINTERMEDIATE PRODUCER]. Pursuant to Clean Air Act section 113(c) and
18 U.S.C. 1001, the penalty for furnishing false, incomplete or
misleading information in this certification or submission is a fine of
up to $10,000 U.S., and/or imprisonment for up to five years.''
(h) Requirements for biointermediate importers. Any biointermediate
importer must meet all the following requirements:
(1) For each biointermediate batch, any biointermediate importer
must have an independent third party do all the following:
(i) Determine the volume of biointermediate in the truck, railcar,
vessel, or other shipping container.
(ii) Determine the name and EPA-assigned registration number of the
foreign biointermediate producer that produced the biointermediate.
(iii) Determine the name and country of registration of the truck,
railcar, vessel, or other shipping container used to transport the
biointermediate to the United States.
(iv) Determine the date and time the truck, railcar, vessel, or
other shipping container arrives at the United States port of entry.
(2) Any biointermediate importer must submit documentation of the
information determined under paragraph (h)(1) of this section within 30
days following the date any truck, railcar, vessel, or other shipping
container transporting biointermediate arrives at the United States port
of entry to all the following:
(i) The foreign biointermediate producer.
(ii) The renewable fuel producer.
(3) The biointermediate importer and the independent third party
must keep records of the audits and reports required under paragraphs
(h)(1) and (2) of this section for five years from the date of creation.
[87 FR 39675, July 1, 2022, as amended at 88 FR 44592, July 12, 2023]
Sec. 80.1479 Alternative recordkeeping requirements for separated yard
waste, separated food waste, separated MSW, and biogenic
waste oils/fats/greases.
(a) Alternative recordkeeping. In lieu of complying with the
recordkeeping requirements in Sec. 80.1454(j), a renewable fuel
producer or biointermediate producer that produces renewable fuel or
biointermediate from separated yard waste, separated food waste,
separated MSW, or biogenic waste oils/fats/greases and uses a feedstock
aggregator to supply these feedstocks may comply with the alternative
recordkeeping requirements of this section.
(b) Registration of the feedstock aggregator. The feedstock
aggregator must register under 40 CFR 1090.805.
(c) QAP participation. (1) The renewable fuel or biointermediate
producer must have their RINs or biointermediate, as applicable,
verified by an independent third-party auditor under an approved QAP
that includes a description of how the independent third-party auditor
will audit each feedstock aggregator.
(2) The independent third-party auditor must conduct a site visit of
each feedstock aggregator's establishment as specified in Sec.
80.1471(f). Instead of verifying RINs with a site visit of the feedstock
aggregator's establishment
[[Page 265]]
every 200 days as specified in Sec. 80.1471(f)(1)(ii), the independent
third-party auditor may verify RINs with a site visit every 380 days.
(d) PTDs. PTDs must accompany transfers of separated yard waste,
separated food waste, separated MSW, and biogenic waste oils/fats/
greases from the point where the feedstock leaves the feedstock
aggregator's establishment to the point the feedstock is delivered to
the renewable fuel production facility, as specified in Sec.
80.1453(f)(1)(i) through (v).
(e) Recordkeeping. The feedstock aggregator must keep all applicable
records for the collection of separated yard waste, separated food
waste, separated MSW, and biogenic waste oils/fats/greases as specified
in Sec. 80.1454(j).
(f) Liability. The feedstock aggregator and renewable fuel producer
are liable for violations as specified in Sec. 80.1461(e).
[88 FR 44592, July 12, 2023]
Subparts N-O [Reserved]
Sec. Appendixes A-G to Part 80 [Reserved]
[[Page 267]]
FINDING AIDS
--------------------------------------------------------------------
A list of CFR titles, subtitles, chapters, subchapters and parts and
an alphabetical list of agencies publishing in the CFR are included in
the CFR Index and Finding Aids volume to the Code of Federal Regulations
which is published separately and revised annually.
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
[[Page 269]]
Table of CFR Titles and Chapters
(Revised as of July 1, 2024)
Title 1--General Provisions
I Administrative Committee of the Federal Register
(Parts 1--49)
II Office of the Federal Register (Parts 50--299)
III Administrative Conference of the United States (Parts
300--399)
IV Miscellaneous Agencies (Parts 400--599)
VI National Capital Planning Commission (Parts 600--699)
Title 2--Grants and Agreements
Subtitle A--Office of Management and Budget Guidance
for Grants and Agreements
I Office of Management and Budget Governmentwide
Guidance for Grants and Agreements (Parts 2--199)
II Office of Management and Budget Guidance (Parts 200--
299)
Subtitle B--Federal Agency Regulations for Grants and
Agreements
III Department of Health and Human Services (Parts 300--
399)
IV Department of Agriculture (Parts 400--499)
VI Department of State (Parts 600--699)
VII Agency for International Development (Parts 700--799)
VIII Department of Veterans Affairs (Parts 800--899)
IX Department of Energy (Parts 900--999)
X Department of the Treasury (Parts 1000--1099)
XI Department of Defense (Parts 1100--1199)
XII Department of Transportation (Parts 1200--1299)
XIII Department of Commerce (Parts 1300--1399)
XIV Department of the Interior (Parts 1400--1499)
XV Environmental Protection Agency (Parts 1500--1599)
XVI U.S. International Development Finance Corporation
(Parts 1600--1699)
XVIII National Aeronautics and Space Administration (Parts
1800--1899)
XX United States Nuclear Regulatory Commission (Parts
2000--2099)
XXII Corporation for National and Community Service (Parts
2200--2299)
XXIII Social Security Administration (Parts 2300--2399)
XXIV Department of Housing and Urban Development (Parts
2400--2499)
[[Page 270]]
XXV National Science Foundation (Parts 2500--2599)
XXVI National Archives and Records Administration (Parts
2600--2699)
XXVII Small Business Administration (Parts 2700--2799)
XXVIII Department of Justice (Parts 2800--2899)
XXIX Department of Labor (Parts 2900--2999)
XXX Department of Homeland Security (Parts 3000--3099)
XXXI Institute of Museum and Library Services (Parts 3100--
3199)
XXXII National Endowment for the Arts (Parts 3200--3299)
XXXIII National Endowment for the Humanities (Parts 3300--
3399)
XXXIV Department of Education (Parts 3400--3499)
XXXV Export-Import Bank of the United States (Parts 3500--
3599)
XXXVI Office of National Drug Control Policy, Executive
Office of the President (Parts 3600--3699)
XXXVII Peace Corps (Parts 3700--3799)
LVIII Election Assistance Commission (Parts 5800--5899)
LIX Gulf Coast Ecosystem Restoration Council (Parts 5900--
5999)
LX Federal Communications Commission (Parts 6000--6099)
Title 3--The President
I Executive Office of the President (Parts 100--199)
Title 4--Accounts
I Government Accountability Office (Parts 1--199)
Title 5--Administrative Personnel
I Office of Personnel Management (Parts 1--1199)
II Merit Systems Protection Board (Parts 1200--1299)
III Office of Management and Budget (Parts 1300--1399)
IV Office of Personnel Management and Office of the
Director of National Intelligence (Parts 1400--
1499)
V The International Organizations Employees Loyalty
Board (Parts 1500--1599)
VI Federal Retirement Thrift Investment Board (Parts
1600--1699)
VIII Office of Special Counsel (Parts 1800--1899)
IX Appalachian Regional Commission (Parts 1900--1999)
XI Armed Forces Retirement Home (Parts 2100--2199)
XIV Federal Labor Relations Authority, General Counsel of
the Federal Labor Relations Authority and Federal
Service Impasses Panel (Parts 2400--2499)
XVI Office of Government Ethics (Parts 2600--2699)
XXI Department of the Treasury (Parts 3100--3199)
XXII Federal Deposit Insurance Corporation (Parts 3200--
3299)
XXIII Department of Energy (Parts 3300--3399)
[[Page 271]]
XXIV Federal Energy Regulatory Commission (Parts 3400--
3499)
XXV Department of the Interior (Parts 3500--3599)
XXVI Department of Defense (Parts 3600--3699)
XXVIII Department of Justice (Parts 3800--3899)
XXIX Federal Communications Commission (Parts 3900--3999)
XXX Farm Credit System Insurance Corporation (Parts 4000--
4099)
XXXI Farm Credit Administration (Parts 4100--4199)
XXXIII U.S. International Development Finance Corporation
(Parts 4300--4399)
XXXIV Securities and Exchange Commission (Parts 4400--4499)
XXXV Office of Personnel Management (Parts 4500--4599)
XXXVI Department of Homeland Security (Parts 4600--4699)
XXXVII Federal Election Commission (Parts 4700--4799)
XL Interstate Commerce Commission (Parts 5000--5099)
XLI Commodity Futures Trading Commission (Parts 5100--
5199)
XLII Department of Labor (Parts 5200--5299)
XLIII National Science Foundation (Parts 5300--5399)
XLV Department of Health and Human Services (Parts 5500--
5599)
XLVI Postal Rate Commission (Parts 5600--5699)
XLVII Federal Trade Commission (Parts 5700--5799)
XLVIII Nuclear Regulatory Commission (Parts 5800--5899)
XLIX Federal Labor Relations Authority (Parts 5900--5999)
L Department of Transportation (Parts 6000--6099)
LII Export-Import Bank of the United States (Parts 6200--
6299)
LIII Department of Education (Parts 6300--6399)
LIV Environmental Protection Agency (Parts 6400--6499)
LV National Endowment for the Arts (Parts 6500--6599)
LVI National Endowment for the Humanities (Parts 6600--
6699)
LVII General Services Administration (Parts 6700--6799)
LVIII Board of Governors of the Federal Reserve System
(Parts 6800--6899)
LIX National Aeronautics and Space Administration (Parts
6900--6999)
LX United States Postal Service (Parts 7000--7099)
LXI National Labor Relations Board (Parts 7100--7199)
LXII Equal Employment Opportunity Commission (Parts 7200--
7299)
LXIII Inter-American Foundation (Parts 7300--7399)
LXIV Merit Systems Protection Board (Parts 7400--7499)
LXV Department of Housing and Urban Development (Parts
7500--7599)
LXVI National Archives and Records Administration (Parts
7600--7699)
LXVII Institute of Museum and Library Services (Parts 7700--
7799)
LXVIII Commission on Civil Rights (Parts 7800--7899)
LXIX Tennessee Valley Authority (Parts 7900--7999)
[[Page 272]]
LXX Court Services and Offender Supervision Agency for the
District of Columbia (Parts 8000--8099)
LXXI Consumer Product Safety Commission (Parts 8100--8199)
LXXIII Department of Agriculture (Parts 8300--8399)
LXXIV Federal Mine Safety and Health Review Commission
(Parts 8400--8499)
LXXVI Federal Retirement Thrift Investment Board (Parts
8600--8699)
LXXVII Office of Management and Budget (Parts 8700--8799)
LXXX Federal Housing Finance Agency (Parts 9000--9099)
LXXXIII Special Inspector General for Afghanistan
Reconstruction (Parts 9300--9399)
LXXXIV Bureau of Consumer Financial Protection (Parts 9400--
9499)
LXXXVI National Credit Union Administration (Parts 9600--
9699)
XCVII Department of Homeland Security Human Resources
Management System (Department of Homeland
Security--Office of Personnel Management) (Parts
9700--9799)
XCVIII Council of the Inspectors General on Integrity and
Efficiency (Parts 9800--9899)
XCIX Military Compensation and Retirement Modernization
Commission (Parts 9900--9999)
C National Council on Disability (Parts 10000--10049)
CI National Mediation Board (Parts 10100--10199)
CII U.S. Office of Special Counsel (Parts 10200--10299)
CIII U.S. Office of Federal Mediation and Conciliation
Service (Parts 10300--10399)
CIV Office of the Intellectual Property Enforcement
Coordinator (Part 10400--10499)
Title 6--Domestic Security
I Department of Homeland Security, Office of the
Secretary (Parts 1--199)
X Privacy and Civil Liberties Oversight Board (Parts
1000--1099)
Title 7--Agriculture
Subtitle A--Office of the Secretary of Agriculture
(Parts 0--26)
Subtitle B--Regulations of the Department of
Agriculture
I Agricultural Marketing Service (Standards,
Inspections, Marketing Practices), Department of
Agriculture (Parts 27--209)
II Food and Nutrition Service, Department of Agriculture
(Parts 210--299)
III Animal and Plant Health Inspection Service, Department
of Agriculture (Parts 300--399)
IV Federal Crop Insurance Corporation, Department of
Agriculture (Parts 400--499)
V Agricultural Research Service, Department of
Agriculture (Parts 500--599)
[[Page 273]]
VI Natural Resources Conservation Service, Department of
Agriculture (Parts 600--699)
VII Farm Service Agency, Department of Agriculture (Parts
700--799)
VIII Agricultural Marketing Service (Federal Grain
Inspection Service, Fair Trade Practices Program),
Department of Agriculture (Parts 800--899)
IX Agricultural Marketing Service (Marketing Agreements
and Orders; Fruits, Vegetables, Nuts), Department
of Agriculture (Parts 900--999)
X Agricultural Marketing Service (Marketing Agreements
and Orders; Milk), Department of Agriculture
(Parts 1000--1199)
XI Agricultural Marketing Service (Marketing Agreements
and Orders; Miscellaneous Commodities), Department
of Agriculture (Parts 1200--1299)
XIV Commodity Credit Corporation, Department of
Agriculture (Parts 1400--1499)
XV Foreign Agricultural Service, Department of
Agriculture (Parts 1500--1599)
XVI [Reserved]
XVII Rural Utilities Service, Department of Agriculture
(Parts 1700--1799)
XVIII Rural Housing Service, Rural Business-Cooperative
Service, Rural Utilities Service, and Farm Service
Agency, Department of Agriculture (Parts 1800--
2099)
XX [Reserved]
XXV Office of Advocacy and Outreach, Department of
Agriculture (Parts 2500--2599)
XXVI Office of Inspector General, Department of Agriculture
(Parts 2600--2699)
XXVII Office of Information Resources Management, Department
of Agriculture (Parts 2700--2799)
XXVIII Office of Operations, Department of Agriculture (Parts
2800--2899)
XXIX Office of Energy Policy and New Uses, Department of
Agriculture (Parts 2900--2999)
XXX Office of the Chief Financial Officer, Department of
Agriculture (Parts 3000--3099)
XXXI Office of Environmental Quality, Department of
Agriculture (Parts 3100--3199)
XXXII Office of Procurement and Property Management,
Department of Agriculture (Parts 3200--3299)
XXXIII Office of Transportation, Department of Agriculture
(Parts 3300--3399)
XXXIV National Institute of Food and Agriculture (Parts
3400--3499)
XXXV Rural Housing Service, Department of Agriculture
(Parts 3500--3599)
XXXVI National Agricultural Statistics Service, Department
of Agriculture (Parts 3600--3699)
[[Page 274]]
XXXVII Economic Research Service, Department of Agriculture
(Parts 3700--3799)
XXXVIII World Agricultural Outlook Board, Department of
Agriculture (Parts 3800--3899)
XLI [Reserved]
XLII Rural Business-Cooperative Service, Department of
Agriculture (Parts 4200--4299)
L Rural Business-Cooperative Service, Rural Housing
Service, and Rural Utilities Service, Department
of Agriculture (Parts 5000--5099)
Title 8--Aliens and Nationality
I Department of Homeland Security (Parts 1--499)
V Executive Office for Immigration Review, Department of
Justice (Parts 1000--1399)
Title 9--Animals and Animal Products
I Animal and Plant Health Inspection Service, Department
of Agriculture (Parts 1--199)
II Agricultural Marketing Service (Fair Trade Practices
Program), Department of Agriculture (Parts 200--
299)
III Food Safety and Inspection Service, Department of
Agriculture (Parts 300--599)
Title 10--Energy
I Nuclear Regulatory Commission (Parts 0--199)
II Department of Energy (Parts 200--699)
III Department of Energy (Parts 700--999)
X Department of Energy (General Provisions) (Parts
1000--1099)
XIII Nuclear Waste Technical Review Board (Parts 1300--
1399)
XVII Defense Nuclear Facilities Safety Board (Parts 1700--
1799)
XVIII Northeast Interstate Low-Level Radioactive Waste
Commission (Parts 1800--1899)
Title 11--Federal Elections
I Federal Election Commission (Parts 1--9099)
II Election Assistance Commission (Parts 9400--9499)
Title 12--Banks and Banking
I Comptroller of the Currency, Department of the
Treasury (Parts 1--199)
II Federal Reserve System (Parts 200--299)
III Federal Deposit Insurance Corporation (Parts 300--399)
[[Page 275]]
IV Export-Import Bank of the United States (Parts 400--
499)
V (Parts 500--599) [Reserved]
VI Farm Credit Administration (Parts 600--699)
VII National Credit Union Administration (Parts 700--799)
VIII Federal Financing Bank (Parts 800--899)
IX (Parts 900--999)[Reserved]
X Consumer Financial Protection Bureau (Parts 1000--
1099)
XI Federal Financial Institutions Examination Council
(Parts 1100--1199)
XII Federal Housing Finance Agency (Parts 1200--1299)
XIII Financial Stability Oversight Council (Parts 1300--
1399)
XIV Farm Credit System Insurance Corporation (Parts 1400--
1499)
XV Department of the Treasury (Parts 1500--1599)
XVI Office of Financial Research, Department of the
Treasury (Parts 1600--1699)
XVII Office of Federal Housing Enterprise Oversight,
Department of Housing and Urban Development (Parts
1700--1799)
XVIII Community Development Financial Institutions Fund,
Department of the Treasury (Parts 1800--1899)
Title 13--Business Credit and Assistance
I Small Business Administration (Parts 1--199)
III Economic Development Administration, Department of
Commerce (Parts 300--399)
IV Emergency Steel Guarantee Loan Board (Parts 400--499)
V Emergency Oil and Gas Guaranteed Loan Board (Parts
500--599)
Title 14--Aeronautics and Space
I Federal Aviation Administration, Department of
Transportation (Parts 1--199)
II Office of the Secretary, Department of Transportation
(Aviation Proceedings) (Parts 200--399)
III Commercial Space Transportation, Federal Aviation
Administration, Department of Transportation
(Parts 400--1199)
V National Aeronautics and Space Administration (Parts
1200--1299)
VI Air Transportation System Stabilization (Parts 1300--
1399)
Title 15--Commerce and Foreign Trade
Subtitle A--Office of the Secretary of Commerce (Parts
0--29)
Subtitle B--Regulations Relating to Commerce and
Foreign Trade
I Bureau of the Census, Department of Commerce (Parts
30--199)
[[Page 276]]
II National Institute of Standards and Technology,
Department of Commerce (Parts 200--299)
III International Trade Administration, Department of
Commerce (Parts 300--399)
IV Foreign-Trade Zones Board, Department of Commerce
(Parts 400--499)
VII Bureau of Industry and Security, Department of
Commerce (Parts 700--799)
VIII Bureau of Economic Analysis, Department of Commerce
(Parts 800--899)
IX National Oceanic and Atmospheric Administration,
Department of Commerce (Parts 900--999)
XI National Technical Information Service, Department of
Commerce (Parts 1100--1199)
XIII East-West Foreign Trade Board (Parts 1300--1399)
XIV Minority Business Development Agency (Parts 1400--
1499)
XV Office of the Under-Secretary for Economic Affairs,
Department of Commerce (Parts 1500--1599)
Subtitle C--Regulations Relating to Foreign Trade
Agreements
XX Office of the United States Trade Representative
(Parts 2000--2099)
Subtitle D--Regulations Relating to Telecommunications
and Information
XXIII National Telecommunications and Information
Administration, Department of Commerce (Parts
2300--2399) [Reserved]
Title 16--Commercial Practices
I Federal Trade Commission (Parts 0--999)
II Consumer Product Safety Commission (Parts 1000--1799)
Title 17--Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1--199)
II Securities and Exchange Commission (Parts 200--399)
IV Department of the Treasury (Parts 400--499)
Title 18--Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of
Energy (Parts 1--399)
III Delaware River Basin Commission (Parts 400--499)
VI Water Resources Council (Parts 700--799)
VIII Susquehanna River Basin Commission (Parts 800--899)
XIII Tennessee Valley Authority (Parts 1300--1399)
[[Page 277]]
Title 19--Customs Duties
I U.S. Customs and Border Protection, Department of
Homeland Security; Department of the Treasury
(Parts 0--199)
II United States International Trade Commission (Parts
200--299)
III International Trade Administration, Department of
Commerce (Parts 300--399)
IV U.S. Immigration and Customs Enforcement, Department
of Homeland Security (Parts 400--599) [Reserved]
Title 20--Employees' Benefits
I Office of Workers' Compensation Programs, Department
of Labor (Parts 1--199)
II Railroad Retirement Board (Parts 200--399)
III Social Security Administration (Parts 400--499)
IV Employees' Compensation Appeals Board, Department of
Labor (Parts 500--599)
V Employment and Training Administration, Department of
Labor (Parts 600--699)
VI Office of Workers' Compensation Programs, Department
of Labor (Parts 700--799)
VII Benefits Review Board, Department of Labor (Parts
800--899)
VIII Joint Board for the Enrollment of Actuaries (Parts
900--999)
IX Office of the Assistant Secretary for Veterans'
Employment and Training Service, Department of
Labor (Parts 1000--1099)
Title 21--Food and Drugs
I Food and Drug Administration, Department of Health and
Human Services (Parts 1--1299)
II Drug Enforcement Administration, Department of Justice
(Parts 1300--1399)
III Office of National Drug Control Policy (Parts 1400--
1499)
Title 22--Foreign Relations
I Department of State (Parts 1--199)
II Agency for International Development (Parts 200--299)
III Peace Corps (Parts 300--399)
IV International Joint Commission, United States and
Canada (Parts 400--499)
V United States Agency for Global Media (Parts 500--599)
VII U.S. International Development Finance Corporation
(Parts 700--799)
IX Foreign Service Grievance Board (Parts 900--999)
X Inter-American Foundation (Parts 1000--1099)
XI International Boundary and Water Commission, United
States and Mexico, United States Section (Parts
1100--1199)
[[Page 278]]
XII United States International Development Cooperation
Agency (Parts 1200--1299)
XIII Millennium Challenge Corporation (Parts 1300--1399)
XIV Foreign Service Labor Relations Board; Federal Labor
Relations Authority; General Counsel of the
Federal Labor Relations Authority; and the Foreign
Service Impasse Disputes Panel (Parts 1400--1499)
XV African Development Foundation (Parts 1500--1599)
XVI Japan-United States Friendship Commission (Parts
1600--1699)
XVII United States Institute of Peace (Parts 1700--1799)
Title 23--Highways
I Federal Highway Administration, Department of
Transportation (Parts 1--999)
II National Highway Traffic Safety Administration and
Federal Highway Administration, Department of
Transportation (Parts 1200--1299)
III National Highway Traffic Safety Administration,
Department of Transportation (Parts 1300--1399)
Title 24--Housing and Urban Development
Subtitle A--Office of the Secretary, Department of
Housing and Urban Development (Parts 0--99)
Subtitle B--Regulations Relating to Housing and Urban
Development
I Office of Assistant Secretary for Equal Opportunity,
Department of Housing and Urban Development (Parts
100--199)
II Office of Assistant Secretary for Housing-Federal
Housing Commissioner, Department of Housing and
Urban Development (Parts 200--299)
III Government National Mortgage Association, Department
of Housing and Urban Development (Parts 300--399)
IV Office of Housing and Office of Multifamily Housing
Assistance Restructuring, Department of Housing
and Urban Development (Parts 400--499)
V Office of Assistant Secretary for Community Planning
and Development, Department of Housing and Urban
Development (Parts 500--599)
VI Office of Assistant Secretary for Community Planning
and Development, Department of Housing and Urban
Development (Parts 600--699) [Reserved]
VII Office of the Secretary, Department of Housing and
Urban Development (Housing Assistance Programs and
Public and Indian Housing Programs) (Parts 700--
799)
[[Page 279]]
VIII Office of the Assistant Secretary for Housing--Federal
Housing Commissioner, Department of Housing and
Urban Development (Section 8 Housing Assistance
Programs, Section 202 Direct Loan Program, Section
202 Supportive Housing for the Elderly Program and
Section 811 Supportive Housing for Persons With
Disabilities Program) (Parts 800--899)
IX Office of Assistant Secretary for Public and Indian
Housing, Department of Housing and Urban
Development (Parts 900--1699)
X Office of Assistant Secretary for Housing--Federal
Housing Commissioner, Department of Housing and
Urban Development (Interstate Land Sales
Registration Program) (Parts 1700--1799)
[Reserved]
XII Office of Inspector General, Department of Housing and
Urban Development (Parts 2000--2099)
XV Emergency Mortgage Insurance and Loan Programs,
Department of Housing and Urban Development (Parts
2700--2799) [Reserved]
XX Office of Assistant Secretary for Housing--Federal
Housing Commissioner, Department of Housing and
Urban Development (Parts 3200--3899)
XXIV Board of Directors of the HOPE for Homeowners Program
(Parts 4000--4099) [Reserved]
XXV Neighborhood Reinvestment Corporation (Parts 4100--
4199)
Title 25--Indians
I Bureau of Indian Affairs, Department of the Interior
(Parts 1--299)
II Indian Arts and Crafts Board, Department of the
Interior (Parts 300--399)
III National Indian Gaming Commission, Department of the
Interior (Parts 500--599)
IV Office of Navajo and Hopi Indian Relocation (Parts
700--899)
V Bureau of Indian Affairs, Department of the Interior,
and Indian Health Service, Department of Health
and Human Services (Part 900--999)
VI Office of the Assistant Secretary, Indian Affairs,
Department of the Interior (Parts 1000--1199)
VII Office of the Special Trustee for American Indians,
Department of the Interior (Parts 1200--1299)
Title 26--Internal Revenue
I Internal Revenue Service, Department of the Treasury
(Parts 1--End)
Title 27--Alcohol, Tobacco Products and Firearms
I Alcohol and Tobacco Tax and Trade Bureau, Department
of the Treasury (Parts 1--399)
[[Page 280]]
II Bureau of Alcohol, Tobacco, Firearms, and Explosives,
Department of Justice (Parts 400--799)
Title 28--Judicial Administration
I Department of Justice (Parts 0--299)
III Federal Prison Industries, Inc., Department of Justice
(Parts 300--399)
V Bureau of Prisons, Department of Justice (Parts 500--
599)
VI Offices of Independent Counsel, Department of Justice
(Parts 600--699)
VII Office of Independent Counsel (Parts 700--799)
VIII Court Services and Offender Supervision Agency for the
District of Columbia (Parts 800--899)
IX National Crime Prevention and Privacy Compact Council
(Parts 900--999)
XI Department of Justice and Department of State (Parts
1100--1199)
Title 29--Labor
Subtitle A--Office of the Secretary of Labor (Parts
0--99)
Subtitle B--Regulations Relating to Labor
I National Labor Relations Board (Parts 100--199)
II Office of Labor-Management Standards, Department of
Labor (Parts 200--299)
III National Railroad Adjustment Board (Parts 300--399)
IV Office of Labor-Management Standards, Department of
Labor (Parts 400--499)
V Wage and Hour Division, Department of Labor (Parts
500--899)
IX Construction Industry Collective Bargaining Commission
(Parts 900--999)
X National Mediation Board (Parts 1200--1299)
XII Federal Mediation and Conciliation Service (Parts
1400--1499)
XIV Equal Employment Opportunity Commission (Parts 1600--
1699)
XVII Occupational Safety and Health Administration,
Department of Labor (Parts 1900--1999)
XX Occupational Safety and Health Review Commission
(Parts 2200--2499)
XXV Employee Benefits Security Administration, Department
of Labor (Parts 2500--2599)
XXVII Federal Mine Safety and Health Review Commission
(Parts 2700--2799)
XL Pension Benefit Guaranty Corporation (Parts 4000--
4999)
[[Page 281]]
Title 30--Mineral Resources
I Mine Safety and Health Administration, Department of
Labor (Parts 1--199)
II Bureau of Safety and Environmental Enforcement,
Department of the Interior (Parts 200--299)
IV Geological Survey, Department of the Interior (Parts
400--499)
V Bureau of Ocean Energy Management, Department of the
Interior (Parts 500--599)
VII Office of Surface Mining Reclamation and Enforcement,
Department of the Interior (Parts 700--999)
XII Office of Natural Resources Revenue, Department of the
Interior (Parts 1200--1299)
Title 31--Money and Finance: Treasury
Subtitle A--Office of the Secretary of the Treasury
(Parts 0--50)
Subtitle B--Regulations Relating to Money and Finance
I Monetary Offices, Department of the Treasury (Parts
51--199)
II Fiscal Service, Department of the Treasury (Parts
200--399)
IV Secret Service, Department of the Treasury (Parts
400--499)
V Office of Foreign Assets Control, Department of the
Treasury (Parts 500--599)
VI Bureau of Engraving and Printing, Department of the
Treasury (Parts 600--699)
VII Federal Law Enforcement Training Center, Department of
the Treasury (Parts 700--799)
VIII Office of Investment Security, Department of the
Treasury (Parts 800--899)
IX Federal Claims Collection Standards (Department of the
Treasury--Department of Justice) (Parts 900--999)
X Financial Crimes Enforcement Network, Department of
the Treasury (Parts 1000--1099)
Title 32--National Defense
Subtitle A--Department of Defense
I Office of the Secretary of Defense (Parts 1--399)
V Department of the Army (Parts 400--699)
VI Department of the Navy (Parts 700--799)
VII Department of the Air Force (Parts 800--1099)
Subtitle B--Other Regulations Relating to National
Defense
XII Department of Defense, Defense Logistics Agency (Parts
1200--1299)
XVI Selective Service System (Parts 1600--1699)
XVII Office of the Director of National Intelligence (Parts
1700--1799)
XVIII National Counterintelligence Center (Parts 1800--1899)
XIX Central Intelligence Agency (Parts 1900--1999)
[[Page 282]]
XX Information Security Oversight Office, National
Archives and Records Administration (Parts 2000--
2099)
XXI National Security Council (Parts 2100--2199)
XXIV Office of Science and Technology Policy (Parts 2400--
2499)
XXVII Office for Micronesian Status Negotiations (Parts
2700--2799)
XXVIII Office of the Vice President of the United States
(Parts 2800--2899)
Title 33--Navigation and Navigable Waters
I Coast Guard, Department of Homeland Security (Parts
1--199)
II Corps of Engineers, Department of the Army, Department
of Defense (Parts 200--399)
IV Great Lakes St. Lawrence Seaway Development
Corporation, Department of Transportation (Parts
400--499)
Title 34--Education
Subtitle A--Office of the Secretary, Department of
Education (Parts 1--99)
Subtitle B--Regulations of the Offices of the
Department of Education
I Office for Civil Rights, Department of Education
(Parts 100--199)
II Office of Elementary and Secondary Education,
Department of Education (Parts 200--299)
III Office of Special Education and Rehabilitative
Services, Department of Education (Parts 300--399)
IV Office of Career, Technical, and Adult Education,
Department of Education (Parts 400--499)
V Office of Bilingual Education and Minority [Reserved]
VI Office of Postsecondary Education, Department of
Education (Parts 600--699)
VII Office of Educational Research and Improvement,
Department of Education (Parts 700--799)
[Reserved]
Subtitle C--Regulations Relating to Education
XI [Reserved]
XII National Council on Disability (Parts 1200--1299)
Title 35 [Reserved]
Title 36--Parks, Forests, and Public Property
I National Park Service, Department of the Interior
(Parts 1--199)
II Forest Service, Department of Agriculture (Parts 200--
299)
III Corps of Engineers, Department of the Army (Parts
300--399)
IV American Battle Monuments Commission (Parts 400--499)
V Smithsonian Institution (Parts 500--599)
VI [Reserved]
[[Page 283]]
VII Library of Congress (Parts 700--799)
VIII Advisory Council on Historic Preservation (Parts 800--
899)
IX Pennsylvania Avenue Development Corporation (Parts
900--999)
X Presidio Trust (Parts 1000--1099)
XI Architectural and Transportation Barriers Compliance
Board (Parts 1100--1199)
XII National Archives and Records Administration (Parts
1200--1299)
XV Oklahoma City National Memorial Trust (Parts 1500--
1599)
XVI Morris K. Udall Scholarship and Excellence in National
Environmental Policy Foundation (Parts 1600--1699)
Title 37--Patents, Trademarks, and Copyrights
I United States Patent and Trademark Office, Department
of Commerce (Parts 1--199)
II U.S. Copyright Office, Library of Congress (Parts
200--299)
III Copyright Royalty Board, Library of Congress (Parts
300--399)
IV National Institute of Standards and Technology,
Department of Commerce (Parts 400--599)
Title 38--Pensions, Bonuses, and Veterans' Relief
I Department of Veterans Affairs (Parts 0--199)
II Armed Forces Retirement Home (Parts 200--299)
Title 39--Postal Service
I United States Postal Service (Parts 1--999)
III Postal Regulatory Commission (Parts 3000--3099)
Title 40--Protection of Environment
I Environmental Protection Agency (Parts 1--1099)
IV Environmental Protection Agency and Department of
Justice (Parts 1400--1499)
V Council on Environmental Quality (Parts 1500--1599)
VI Chemical Safety and Hazard Investigation Board (Parts
1600--1699)
VII Environmental Protection Agency and Department of
Defense; Uniform National Discharge Standards for
Vessels of the Armed Forces (Parts 1700--1799)
VIII Gulf Coast Ecosystem Restoration Council (Parts 1800--
1899)
IX Federal Permitting Improvement Steering Council (Part
1900)
Title 41--Public Contracts and Property Management
Subtitle A--Federal Procurement Regulations System
[Note]
[[Page 284]]
Subtitle B--Other Provisions Relating to Public
Contracts
50 Public Contracts, Department of Labor (Parts 50-1--50-
999)
51 Committee for Purchase From People Who Are Blind or
Severely Disabled (Parts 51-1--51-99)
60 Office of Federal Contract Compliance Programs, Equal
Employment Opportunity, Department of Labor (Parts
60-1--60-999)
61 Office of the Assistant Secretary for Veterans'
Employment and Training Service, Department of
Labor (Parts 61-1--61-999)
62--100 [Reserved]
Subtitle C--Federal Property Management Regulations
System
101 Federal Property Management Regulations (Parts 101-1--
101-99)
102 Federal Management Regulation (Parts 102-1--102-299)
103--104 [Reserved]
105 General Services Administration (Parts 105-1--105-999)
109 Department of Energy Property Management Regulations
(Parts 109-1--109-99)
114 Department of the Interior (Parts 114-1--114-99)
115 Environmental Protection Agency (Parts 115-1--115-99)
128 Department of Justice (Parts 128-1--128-99)
129--200 [Reserved]
Subtitle D--Federal Acquisition Supply Chain Security
201 Federal Acquisition Security Council (Parts 201-1--
201-99)
Subtitle E [Reserved]
Subtitle F--Federal Travel Regulation System
300 General (Parts 300-1--300-99)
301 Temporary Duty (TDY) Travel Allowances (Parts 301-1--
301-99)
302 Relocation Allowances (Parts 302-1--302-99)
303 Payment of Expenses Connected with the Death of
Certain Employees (Part 303-1--303-99)
304 Payment of Travel Expenses from a Non-Federal Source
(Parts 304-1--304-99)
Title 42--Public Health
I Public Health Service, Department of Health and Human
Services (Parts 1--199)
II--III [Reserved]
IV Centers for Medicare & Medicaid Services, Department
of Health and Human Services (Parts 400--699)
V Office of Inspector General-Health Care, Department of
Health and Human Services (Parts 1000--1099)
Title 43--Public Lands: Interior
Subtitle A--Office of the Secretary of the Interior
(Parts 1--199)
[[Page 285]]
Subtitle B--Regulations Relating to Public Lands
I Bureau of Reclamation, Department of the Interior
(Parts 400--999)
II Bureau of Land Management, Department of the Interior
(Parts 1000--9999)
III Utah Reclamation Mitigation and Conservation
Commission (Parts 10000--10099)
Title 44--Emergency Management and Assistance
I Federal Emergency Management Agency, Department of
Homeland Security (Parts 0--399)
IV Department of Commerce and Department of
Transportation (Parts 400--499)
Title 45--Public Welfare
Subtitle A--Department of Health and Human Services
(Parts 1--199)
Subtitle B--Regulations Relating to Public Welfare
II Office of Family Assistance (Assistance Programs),
Administration for Children and Families,
Department of Health and Human Services (Parts
200--299)
III Office of Child Support Services, Administration of
Families and Services, Department of Health and
Human Services (Parts 300--399)
IV Office of Refugee Resettlement, Administration for
Children and Families, Department of Health and
Human Services (Parts 400--499)
V Foreign Claims Settlement Commission of the United
States, Department of Justice (Parts 500--599)
VI National Science Foundation (Parts 600--699)
VII Commission on Civil Rights (Parts 700--799)
VIII Office of Personnel Management (Parts 800--899)
IX Denali Commission (Parts 900--999)
X Office of Community Services, Administration for
Children and Families, Department of Health and
Human Services (Parts 1000--1099)
XI National Foundation on the Arts and the Humanities
(Parts 1100--1199)
XII Corporation for National and Community Service (Parts
1200--1299)
XIII Administration for Children and Families, Department
of Health and Human Services (Parts 1300--1399)
XVI Legal Services Corporation (Parts 1600--1699)
XVII National Commission on Libraries and Information
Science (Parts 1700--1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800--
1899)
XXI Commission of Fine Arts (Parts 2100--2199)
[[Page 286]]
XXIII Arctic Research Commission (Parts 2300--2399)
XXIV James Madison Memorial Fellowship Foundation (Parts
2400--2499)
XXV Corporation for National and Community Service (Parts
2500--2599)
Title 46--Shipping
I Coast Guard, Department of Homeland Security (Parts
1--199)
II Maritime Administration, Department of Transportation
(Parts 200--399)
III Coast Guard (Great Lakes Pilotage), Department of
Homeland Security (Parts 400--499)
IV Federal Maritime Commission (Parts 500--599)
Title 47--Telecommunication
I Federal Communications Commission (Parts 0--199)
II Office of Science and Technology Policy and National
Security Council (Parts 200--299)
III National Telecommunications and Information
Administration, Department of Commerce (Parts
300--399)
IV National Telecommunications and Information
Administration, Department of Commerce, and
National Highway Traffic Safety Administration,
Department of Transportation (Parts 400--499)
V The First Responder Network Authority (Parts 500--599)
Title 48--Federal Acquisition Regulations System
1 Federal Acquisition Regulation (Parts 1--99)
2 Defense Acquisition Regulations System, Department of
Defense (Parts 200--299)
3 Health and Human Services (Parts 300--399)
4 Department of Agriculture (Parts 400--499)
5 General Services Administration (Parts 500--599)
6 Department of State (Parts 600--699)
7 Agency for International Development (Parts 700--799)
8 Department of Veterans Affairs (Parts 800--899)
9 Department of Energy (Parts 900--999)
10 Department of the Treasury (Parts 1000--1099)
12 Department of Transportation (Parts 1200--1299)
13 Department of Commerce (Parts 1300--1399)
14 Department of the Interior (Parts 1400--1499)
15 Environmental Protection Agency (Parts 1500--1599)
16 Office of Personnel Management, Federal Employees
Health Benefits Acquisition Regulation (Parts
1600--1699)
17 Office of Personnel Management (Parts 1700--1799)
[[Page 287]]
18 National Aeronautics and Space Administration (Parts
1800--1899)
19 Broadcasting Board of Governors (Parts 1900--1999)
20 Nuclear Regulatory Commission (Parts 2000--2099)
21 Office of Personnel Management, Federal Employees
Group Life Insurance Federal Acquisition
Regulation (Parts 2100--2199)
23 Social Security Administration (Parts 2300--2399)
24 Department of Housing and Urban Development (Parts
2400--2499)
25 National Science Foundation (Parts 2500--2599)
28 Department of Justice (Parts 2800--2899)
29 Department of Labor (Parts 2900--2999)
30 Department of Homeland Security, Homeland Security
Acquisition Regulation (HSAR) (Parts 3000--3099)
34 Department of Education Acquisition Regulation (Parts
3400--3499)
51 Department of the Army Acquisition Regulations (Parts
5100--5199) [Reserved]
52 Department of the Navy Acquisition Regulations (Parts
5200--5299)
53 Department of the Air Force Federal Acquisition
Regulation Supplement (Parts 5300--5399)
[Reserved]
54 Defense Logistics Agency, Department of Defense (Parts
5400--5499)
57 African Development Foundation (Parts 5700--5799)
61 Civilian Board of Contract Appeals, General Services
Administration (Parts 6100--6199)
99 Cost Accounting Standards Board, Office of Federal
Procurement Policy, Office of Management and
Budget (Parts 9900--9999)
Title 49--Transportation
Subtitle A--Office of the Secretary of Transportation
(Parts 1--99)
Subtitle B--Other Regulations Relating to
Transportation
I Pipeline and Hazardous Materials Safety
Administration, Department of Transportation
(Parts 100--199)
II Federal Railroad Administration, Department of
Transportation (Parts 200--299)
III Federal Motor Carrier Safety Administration,
Department of Transportation (Parts 300--399)
IV Coast Guard, Department of Homeland Security (Parts
400--499)
V National Highway Traffic Safety Administration,
Department of Transportation (Parts 500--599)
VI Federal Transit Administration, Department of
Transportation (Parts 600--699)
VII National Railroad Passenger Corporation (AMTRAK)
(Parts 700--799)
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VIII National Transportation Safety Board (Parts 800--999)
X Surface Transportation Board (Parts 1000--1399)
XI Research and Innovative Technology Administration,
Department of Transportation (Parts 1400--1499)
[Reserved]
XII Transportation Security Administration, Department of
Homeland Security (Parts 1500--1699)
Title 50--Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of
the Interior (Parts 1--199)
II National Marine Fisheries Service, National Oceanic
and Atmospheric Administration, Department of
Commerce (Parts 200--299)
III International Fishing and Related Activities (Parts
300--399)
IV Joint Regulations (United States Fish and Wildlife
Service, Department of the Interior and National
Marine Fisheries Service, National Oceanic and
Atmospheric Administration, Department of
Commerce); Endangered Species Committee
Regulations (Parts 400--499)
V Marine Mammal Commission (Parts 500--599)
VI Fishery Conservation and Management, National Oceanic
and Atmospheric Administration, Department of
Commerce (Parts 600--699)
[[Page 289]]
Alphabetical List of Agencies Appearing in the CFR
(Revised as of July 1, 2024)
CFR Title, Subtitle or
Agency Chapter
Administrative Conference of the United States 1, III
Advisory Council on Historic Preservation 36, VIII
Advocacy and Outreach, Office of 7, XXV
Afghanistan Reconstruction, Special Inspector 5, LXXXIII
General for
African Development Foundation 22, XV
Federal Acquisition Regulation 48, 57
Agency for International Development 2, VII; 22, II
Federal Acquisition Regulation 48, 7
Agricultural Marketing Service 7, I, VIII, IX, X, XI; 9,
II
Agricultural Research Service 7, V
Agriculture, Department of 2, IV; 5, LXXIII
Advocacy and Outreach, Office of 7, XXV
Agricultural Marketing Service 7, I, VIII, IX, X, XI; 9,
II
Agricultural Research Service 7, V
Animal and Plant Health Inspection Service 7, III; 9, I
Chief Financial Officer, Office of 7, XXX
Commodity Credit Corporation 7, XIV
Economic Research Service 7, XXXVII
Energy Policy and New Uses, Office of 2, IX; 7, XXIX
Environmental Quality, Office of 7, XXXI
Farm Service Agency 7, VII, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Forest Service 36, II
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Institute of Food and Agriculture 7, XXXIV
Natural Resources Conservation Service 7, VI
Operations, Office of 7, XXVIII
Procurement and Property Management, Office of 7, XXXII
Rural Business-Cooperative Service 7, XVIII, XLII
Rural Development Administration 7, XLII
Rural Housing Service 7, XVIII, XXXV
Rural Utilities Service 7, XVII, XVIII, XLII
Secretary of Agriculture, Office of 7, Subtitle A
Transportation, Office of 7, XXXIII
World Agricultural Outlook Board 7, XXXVIII
Air Force, Department of 32, VII
Federal Acquisition Regulation Supplement 48, 53
Air Transportation Stabilization Board 14, VI
Alcohol and Tobacco Tax and Trade Bureau 27, I
Alcohol, Tobacco, Firearms, and Explosives, 27, II
Bureau of
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
American Indians, Office of the Special Trustee 25, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers 36, XI
Compliance Board
[[Page 290]]
Arctic Research Commission 45, XXIII
Armed Forces Retirement Home 5, XI; 38, II
Army, Department of 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Benefits Review Board 20, VII
Bilingual Education and Minority Languages 34, V
Affairs, Office of
Blind or Severely Disabled, Committee for 41, 51
Purchase from People Who Are
Federal Acquisition Regulation 48, 19
Career, Technical, and Adult Education, Office 34, IV
of
Census Bureau 15, I
Centers for Medicare & Medicaid Services 42, IV
Central Intelligence Agency 32, XIX
Chemical Safety and Hazard Investigation Board 40, VI
Chief Financial Officer, Office of 7, XXX
Child Support Services, Office of 45, III
Children and Families, Administration for 45, II, IV, X, XIII
Civil Rights, Commission on 5, LXVIII; 45, VII
Civil Rights, Office for 34, I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Commerce, Department of 2, XIII; 44, IV; 50, VI
Census Bureau 15, I
Economic Affairs, Office of the Under- 15, XV
Secretary for
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Emergency Management and Assistance 44, IV
Federal Acquisition Regulation 48, 13
Foreign-Trade Zones Board 15, IV
Industry and Security, Bureau of 15, VII
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II; 37, IV
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric 15, IX; 50, II, III, IV,
Administration VI
National Technical Information Service 15, XI
National Telecommunications and Information 15, XXIII; 47, III, IV
Administration
National Weather Service 15, IX
Patent and Trademark Office, United States 37, I
Secretary of Commerce, Office of 15, Subtitle A
Commercial Space Transportation 14, III
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 5, XLI; 17, I
Community Planning and Development, Office of 24, V, VI
Assistant Secretary for
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining 29, IX
Commission
Consumer Financial Protection Bureau 5, LXXXIV; 12, X
Consumer Product Safety Commission 5, LXXI; 16, II
Copyright Royalty Board 37, III
Corporation for National and Community Service 2, XXII; 45, XII, XXV
Cost Accounting Standards Board 48, 99
Council on Environmental Quality 40, V
Council of the Inspectors General on Integrity 5, XCVIII
and Efficiency
Court Services and Offender Supervision Agency 5, LXX; 28, VIII
for the District of Columbia
Customs and Border Protection 19, I
Defense, Department of 2, XI; 5, XXVI; 32,
Subtitle A; 40, VII
Advanced Research Projects Agency 32, I
Air Force Department 32, VII
Army Department 32, V; 33, II; 36, III;
48, 51
Defense Acquisition Regulations System 48, 2
Defense Intelligence Agency 32, I
[[Page 291]]
Defense Logistics Agency 32, I, XII; 48, 54
Engineers, Corps of 33, II; 36, III
National Imagery and Mapping Agency 32, I
Navy, Department of 32, VI; 48, 52
Secretary of Defense, Office of 2, XI; 32, I
Defense Contract Audit Agency 32, I
Defense Intelligence Agency 32, I
Defense Logistics Agency 32, XII; 48, 54
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Denali Commission 45, IX
Disability, National Council on 5, C; 34, XII
District of Columbia, Court Services and 5, LXX; 28, VIII
Offender Supervision Agency for the
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Office of the Under-Secretary 15, XV
for
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Economic Research Service 7, XXXVII
Education, Department of 2, XXXIV; 5, LIII
Bilingual Education and Minority Languages 34, V
Affairs, Office of
Career, Technical, and Adult Education, Office 34, IV
of
Civil Rights, Office for 34, I
Educational Research and Improvement, Office 34, VII
of
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, 34, III
Office of
Educational Research and Improvement, Office of 34, VII
Election Assistance Commission 2, LVIII; 11, II
Elementary and Secondary Education, Office of 34, II
Emergency Oil and Gas Guaranteed Loan Board 13, V
Emergency Steel Guarantee Loan Board 13, IV
Employee Benefits Security Administration 29, XXV
Employees' Compensation Appeals Board 20, IV
Employees Loyalty Board 5, V
Employment and Training Administration 20, V
Employment Policy, National Commission for 1, IV
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 2, IX; 5, XXIII; 10, II,
III, X
Federal Acquisition Regulation 48, 9
Federal Energy Regulatory Commission 5, XXIV; 18, I
Property Management Regulations 41, 109
Energy, Office of 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 2, XV; 5, LIV; 40, I, IV,
VII
Federal Acquisition Regulation 48, 15
Property Management Regulations 41, 115
Environmental Quality, Office of 7, XXXI
Equal Employment Opportunity Commission 5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary 24, I
for
Executive Office of the President 3, I
Environmental Quality, Council on 40, V
Management and Budget, Office of 2, Subtitle A; 5, III,
LXXVII; 14, VI; 48, 99
National Drug Control Policy, Office of 2, XXXVI; 21, III
National Security Council 32, XXI; 47, II
Presidential Documents 3
Science and Technology Policy, Office of 32, XXIV; 47, II
Trade Representative, Office of the United 15, XX
States
[[Page 292]]
Export-Import Bank of the United States 2, XXXV; 5, LII; 12, IV
Families and Services, Administration of 45, III
Family Assistance, Office of 45, II
Farm Credit Administration 5, XXXI; 12, VI
Farm Credit System Insurance Corporation 5, XXX; 12, XIV
Farm Service Agency 7, VII, XVIII
Federal Acquisition Regulation 48, 1
Federal Acquisition Security Council 41, 201
Federal Aviation Administration 14, I
Commercial Space Transportation 14, III
Federal Claims Collection Standards 31, IX
Federal Communications Commission 2, LX; 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 5, XXII; 12, III
Federal Election Commission 5, XXXVII; 11, I
Federal Emergency Management Agency 44, I
Federal Employees Group Life Insurance Federal 48, 21
Acquisition Regulation
Federal Employees Health Benefits Acquisition 48, 16
Regulation
Federal Energy Regulatory Commission 5, XXIV; 18, I
Federal Financial Institutions Examination 12, XI
Council
Federal Financing Bank 12, VIII
Federal Highway Administration 23, I, II
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Enterprise Oversight Office 12, XVII
Federal Housing Finance Agency 5, LXXX; 12, XII
Federal Labor Relations Authority 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Management Regulation 41, 102
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 5, CIII; 29, XII
Federal Mine Safety and Health Review Commission 5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration 49, III
Federal Permitting Improvement Steering Council 40, IX
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Board of Governors 5, LVIII
Federal Retirement Thrift Investment Board 5, VI, LXXVI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 5, XLVII; 16, I
Federal Transit Administration 49, VI
Federal Travel Regulation System 41, Subtitle F
Financial Crimes Enforcement Network 31, X
Financial Research Office 12, XVI
Financial Stability Oversight Council 12, XIII
Fine Arts, Commission of 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of the 45, V
United States
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Services Administration 5, LVII; 41, 105
Contract Appeals, Board of 48, 61
[[Page 293]]
Federal Acquisition Regulation 48, 5
Federal Management Regulation 41, 102
Federal Property Management Regulations 41, 101
Federal Travel Regulation System 41, Subtitle F
General 41, 300
Payment From a Non-Federal Source for Travel 41, 304
Expenses
Payment of Expenses Connected With the Death 41, 303
of Certain Employees
Relocation Allowances 41, 302
Temporary Duty (TDY) Travel Allowances 41, 301
Geological Survey 30, IV
Government Accountability Office 4, I
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grain Inspection, Packers and Stockyards 7, VIII; 9, II
Administration
Great Lakes St. Lawrence Seaway Development 33, IV
Corporation
Gulf Coast Ecosystem Restoration Council 2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 2, III; 5, XLV; 45,
Subtitle A
Centers for Medicare & Medicaid Services 42, IV
Child Support Services, Office of 45, III
Children and Families, Administration for 45, II, IV, X, XIII
Community Services, Office of 45, X
Families and Services, Administration of 45, III
Family Assistance, Office of 45, II
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Indian Health Service 25, V
Inspector General (Health Care), Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Homeland Security, Department of 2, XXX; 5, XXXVI; 6, I; 8,
I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Customs and Border Protection 19, I
Federal Emergency Management Agency 44, I
Human Resources Management and Labor Relations 5, XCVII
Systems
Immigration and Customs Enforcement Bureau 19, IV
Transportation Security Administration 49, XII
HOPE for Homeowners Program, Board of Directors 24, XXIV
of
Housing and Urban Development, Department of 2, XXIV; 5, LXV; 24,
Subtitle B
Community Planning and Development, Office of 24, V, VI
Assistant Secretary for
Equal Opportunity, Office of Assistant 24, I
Secretary for
Federal Acquisition Regulation 48, 24
Federal Housing Enterprise Oversight, Office 12, XVII
of
Government National Mortgage Association 24, III
Housing--Federal Housing Commissioner, Office 24, II, VIII, X, XX
of Assistant Secretary for
Housing, Office of, and Multifamily Housing 24, IV
Assistance Restructuring, Office of
Inspector General, Office of 24, XII
Public and Indian Housing, Office of Assistant 24, IX
Secretary for
Secretary, Office of 24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of 24, II, VIII, X, XX
Assistant Secretary for
Housing, Office of, and Multifamily Housing 24, IV
Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau 19, IV
Immigration Review, Executive Office for 8, V
Independent Counsel, Office of 28, VII
Independent Counsel, Offices of 28, VI
Indian Affairs, Bureau of 25, I, V
[[Page 294]]
Indian Affairs, Office of the Assistant 25, VI
Secretary
Indian Arts and Crafts Board 25, II
Indian Health Service 25, V
Industry and Security, Bureau of 15, VII
Information Resources Management, Office of 7, XXVII
Information Security Oversight Office, National 32, XX
Archives and Records Administration
Inspector General
Agriculture Department 7, XXVI
Health and Human Services Department 42, V
Housing and Urban Development Department 24, XII, XV
Institute of Peace, United States 22, XVII
Intellectual Property Enforcement Coordinator, 5, CIV
Office of
Inter-American Foundation 5, LXIII; 22, X
Interior, Department of 2, XIV
American Indians, Office of the Special 25, VII
Trustee
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I, V
Indian Affairs, Office of the Assistant 25, VI
Secretary
Indian Arts and Crafts Board 25, II
Land Management, Bureau of 43, II
National Indian Gaming Commission 25, III
National Park Service 36, I
Natural Resource Revenue, Office of 30, XII
Ocean Energy Management, Bureau of 30, V
Reclamation, Bureau of 43, I
Safety and Environmental Enforcement, Bureau 30, II
of
Secretary of the Interior, Office of 2, XIV; 43, Subtitle A
Surface Mining Reclamation and Enforcement, 30, VII
Office of
Internal Revenue Service 26, I
International Boundary and Water Commission, 22, XI
United States and Mexico, United States
Section
International Development, United States Agency 22, II
for
Federal Acquisition Regulation 48, 7
International Development Cooperation Agency, 22, XII
United States
International Development Finance Corporation, 2, XVI; 5, XXXIII; 22, VII
U.S.
International Joint Commission, United States 22, IV
and Canada
International Organizations Employees Loyalty 5, V
Board
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 5, XL
Investment Security, Office of 31, VIII
James Madison Memorial Fellowship Foundation 45, XXIV
Japan-United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice, Department of 2, XXVIII; 5, XXVIII; 28,
I, XI; 40, IV
Alcohol, Tobacco, Firearms, and Explosives, 27, II
Bureau of
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 31, IX
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the 45, V
United States
Immigration Review, Executive Office for 8, V
Independent Counsel, Offices of 28, VI
Prisons, Bureau of 28, V
Property Management Regulations 41, 128
Labor, Department of 2, XXIX; 5, XLII
Benefits Review Board 20, VII
Employee Benefits Security Administration 29, XXV
[[Page 295]]
Employees' Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office 41, 60
of
Federal Procurement Regulations System 41, 50
Labor-Management Standards, Office of 29, II, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans' Employment and Training Service, 41, 61; 20, IX
Office of the Assistant Secretary for
Wage and Hour Division 29, V
Workers' Compensation Programs, Office of 20, I, VI
Labor-Management Standards, Office of 29, II, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Libraries and Information Science, National 45, XVII
Commission on
Library of Congress 36, VII
Copyright Royalty Board 37, III
U.S. Copyright Office 37, II
Management and Budget, Office of 5, III, LXXVII; 14, VI;
48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II, LXIV
Micronesian Status Negotiations, Office for 32, XXVII
Military Compensation and Retirement 5, XCIX
Modernization Commission
Millennium Challenge Corporation 22, XIII
Mine Safety and Health Administration 30, I
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Morris K. Udall Scholarship and Excellence in 36, XVI
National Environmental Policy Foundation
Museum and Library Services, Institute of 2, XXXI
National Aeronautics and Space Administration 2, XVIII; 5, LIX; 14, V
Federal Acquisition Regulation 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National and Community Service, Corporation for 2, XXII; 45, XII, XXV
National Archives and Records Administration 2, XXVI; 5, LXVI; 36, XII
Information Security Oversight Office 32, XX
National Capital Planning Commission 1, IV, VI
National Counterintelligence Center 32, XVIII
National Credit Union Administration 5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact 28, IX
Council
National Drug Control Policy, Office of 2, XXXVI; 21, III
National Endowment for the Arts 2, XXXII
National Endowment for the Humanities 2, XXXIII
National Foundation on the Arts and the 45, XI
Humanities
National Geospatial-Intelligence Agency 32, I
National Highway Traffic Safety Administration 23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency 32, I
National Indian Gaming Commission 25, III
National Institute of Food and Agriculture 7, XXXIV
National Institute of Standards and Technology 15, II; 37, IV
National Intelligence, Office of Director of 5, IV; 32, XVII
National Labor Relations Board 5, LXI; 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 5, CI; 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV,
VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
[[Page 296]]
National Science Foundation 2, XXV; 5, XLIII; 45, VI
Federal Acquisition Regulation 48, 25
National Security Council 32, XXI; 47, II
National Technical Information Service 15, XI
National Telecommunications and Information 15, XXIII; 47, III, IV, V
Administration
National Transportation Safety Board 49, VIII
Natural Resource Revenue, Office of 30, XII
Natural Resources Conservation Service 7, VI
Navajo and Hopi Indian Relocation, Office of 25, IV
Navy, Department of 32, VI
Federal Acquisition Regulation 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Northeast Interstate Low-Level Radioactive Waste 10, XVIII
Commission
Nuclear Regulatory Commission 2, XX; 5, XLVIII; 10, I
Federal Acquisition Regulation 48, 20
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Ocean Energy Management, Bureau of 30, V
Oklahoma City National Memorial Trust 36, XV
Operations Office 7, XXVIII
Patent and Trademark Office, United States 37, I
Payment From a Non-Federal Source for Travel 41, 304
Expenses
Payment of Expenses Connected With the Death of 41, 303
Certain Employees
Peace Corps 2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension Benefit Guaranty Corporation 29, XL
Personnel Management, Office of 5, I, IV, XXXV; 45, VIII
Federal Acquisition Regulation 48, 17
Federal Employees Group Life Insurance Federal 48, 21
Acquisition Regulation
Federal Employees Health Benefits Acquisition 48, 16
Regulation
Human Resources Management and Labor Relations 5, XCVII
Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety 49, I
Administration
Postal Regulatory Commission 5, XLVI; 39, III
Postal Service, United States 5, LX; 39, I
Postsecondary Education, Office of 34, VI
President's Commission on White House 1, IV
Fellowships
Presidential Documents 3
Presidio Trust 36, X
Prisons, Bureau of 28, V
Privacy and Civil Liberties Oversight Board 6, X
Procurement and Property Management, Office of 7, XXXII
Public and Indian Housing, Office of Assistant 24, IX
Secretary for
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation, Bureau of 43, I
Refugee Resettlement, Office of 45, IV
Relocation Allowances 41, 302
Research and Innovative Technology 49, XI
Administration
Rural Business-Cooperative Service 7, XVIII, XLII, L
Rural Housing Service 7, XVIII, XXXV, L
Rural Utilities Service 7, XVII, XVIII, XLII, L
Safety and Environmental Enforcement, Bureau of 30, II
Science and Technology Policy, Office of 32, XXIV; 47, II
Secret Service 31, IV
Securities and Exchange Commission 5, XXXIV; 17, II
Selective Service System 32, XVI
Small Business Administration 2, XXVII; 13, I
Smithsonian Institution 36, V
Social Security Administration 2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States 5, XI
Special Counsel, Office of 5, VIII
[[Page 297]]
Special Education and Rehabilitative Services, 34, III
Office of
State, Department of 2, VI; 22, I; 28, XI
Federal Acquisition Regulation 48, 6
Surface Mining Reclamation and Enforcement, 30, VII
Office of
Surface Transportation Board 49, X
Susquehanna River Basin Commission 18, VIII
Tennessee Valley Authority 5, LXIX; 18, XIII
Trade Representative, United States, Office of 15, XX
Transportation, Department of 2, XII; 5, L
Commercial Space Transportation 14, III
Emergency Management and Assistance 44, IV
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II
Federal Motor Carrier Safety Administration 49, III
Federal Railroad Administration 49, II
Federal Transit Administration 49, VI
Great Lakes St. Lawrence Seaway Development 33, IV
Corporation
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 47, IV; 49, V
Pipeline and Hazardous Materials Safety 49, I
Administration
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Transportation Statistics Bureau 49, XI
Transportation, Office of 7, XXXIII
Transportation Security Administration 49, XII
Transportation Statistics Bureau 49, XI
Travel Allowances, Temporary Duty (TDY) 41, 301
Treasury, Department of the 2, X; 5, XXI; 12, XV; 17,
IV; 31, IX
Alcohol and Tobacco Tax and Trade Bureau 27, I
Community Development Financial Institutions 12, XVIII
Fund
Comptroller of the Currency 12, I
Customs and Border Protection 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Claims Collection Standards 31, IX
Federal Law Enforcement Training Center 31, VII
Financial Crimes Enforcement Network 31, X
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Investment Security, Office of 31, VIII
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Truman, Harry S. Scholarship Foundation 45, XVIII
United States Agency for Global Media 22, V
United States and Canada, International Joint 22, IV
Commission
United States and Mexico, International Boundary 22, XI
and Water Commission, United States Section
U.S. Copyright Office 37, II
U.S. Office of Special Counsel 5, CII
Utah Reclamation Mitigation and Conservation 43, III
Commission
Veterans Affairs, Department of 2, VIII; 38, I
Federal Acquisition Regulation 48, 8
Veterans' Employment and Training Service, 41, 61; 20, IX
Office of the Assistant Secretary for
Vice President of the United States, Office of 32, XXVIII
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers' Compensation Programs, Office of 20, I, VI
World Agricultural Outlook Board 7, XXXVIII
[[Page 299]]
List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations (CFR) that
were made by documents published in the Federal Register since January
1, 2019 are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to Federal Register
pages. The user should consult the entries for chapters, parts and
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the
annual edition of the monthly List of CFR Sections Affected (LSA). The
LSA is available at www.govinfo.gov. For changes to this volume of the
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963,
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes.
The ``List of CFR Sections Affected 1986-2000'' is available at
www.govinfo.gov.
2019
40 CFR
84 FR
Page
Chapter I
80.2 (aa) added....................................................69340
80.27 (d)(2) revised...............................................27021
80.27 (a)(2)(ii) table amended.....................................49474
80.28 (g)(6)(iii), (8) introductory text, and (ii) revised.........27021
80.70 (j)(3) revised................................................2456
80.501 (a)(6) and (7) redesignated as (a)(7) and (8); new (a)(6)
added; (b) revised.........................................69340
80.590 Heading and (a) introductory text revised; (a)(7)(viii)
added......................................................69341
80.598 (a)(2)(i)(G) and (b)(8)(iii) revised........................69341
80.602 Heading, (a), and (b)(4)(i) revised.........................69341
80.605 Added.......................................................69341
80.1401 Amended; eff. 7-10-19......................................27021
80.1402 Added; eff. 7-10-19........................................27022
80.1435 Added; eff. 7-10-19........................................27022
80.1451 (c)(2) introductory text revised; (c)(2)(i) through
(xviii) redesignated as (c)(2)(i)(A) through (R); new
(c)(2)(i) introductory text and new (ii) added; eff. 7-10-
19.........................................................27023
80.1452 (c)(12) revised; (c)(15) added; eff. 7-10-19...............27024
80.1454 (i)(1), (2), (u), and (v) added; eff. 7-10-19..............27024
80.1464 (a)(4), (5), (6), (b)(5), (6), (7), (c)(3), (4), and (5)
added; eff. 7-10-19........................................27024
80.1503 (a)(1)(vi)(C), (b)(1)(vi)(C), (D), and (E) removed;
(a)(1)(vi)(B) and (b)(1)(vi)(B) revised....................27025
80.1504 (f) and (g) removed........................................27025
2020
40 CFR
85 FR
Page
Chapter I
80.1 Revised.......................................................78465
80.2 Revised.......................................................78465
80.3 Removed; eff. 1-1-22..........................................78467
80.7 (c) amended...................................................78467
80.10 Added.........................................................7070
80.22 Removed; eff. 1-1-22.........................................78467
80.23 Removed; eff. 1-1-22.........................................78467
80.26 Removed; eff. 1-1-22.........................................78467
80.27 (b) and (e)(1)(i) revised.....................................7070
80.27 Removed; eff. 1-1-22.........................................78467
80.28 Removed; eff. 1-1-22.........................................78467
80.29 Removed; eff. 1-1-22.........................................78467
80.30 Removed; eff. 1-1-22.........................................78467
80.32 Removed; eff. 1-1-22.........................................78467
80.33 Removed; eff. 1-1-22.........................................78467
80.46 (a), (b), and (d) through (g) revised; (h)(1)(iv), (v),
(vii), (viii), (x), (xiii), (xv), and (xvi) removed.........7070
[[Page 300]]
80.47 (b), (c)(2)(i), (ii), (3), (d)(2), (e)(2), (f)(2), (g)(2),
(h)(2), (i)(2), (j)(2), (l)(2)(i), (4), (n)(1), (2)(i),
(o)(1), (2)(i), (p)(1), (2)(i), and (3)(i) revised..........7070
80.69 (a)(11)(viii)(C) revised......................................7072
80.40--80.89 (Subpart D) Removed; eff. 1-1-22......................78467
80.93 (d)(4) revised................................................7072
80.90--80.124 (Subpart E) Removed; eff. 1-1-22.....................78467
80.125--80.135 (Subpart F) Removed; eff. 1-1-22....................78467
80.174 (b) and (c) revised..........................................7072
80.140--80.177 (Subpart G) Removed; eff. 1-1-22....................78467
80.235 (b) revised..................................................7073
80.290 (b) revised..................................................7073
80.180--80.415 (Subpart H) Removed; eff. 1-1-22....................78467
80.533 (b) revised..................................................7073
80.574 (b) revised..................................................7073
80.585 (d)(1) and (2) amended; (d)(4) revised.......................7073
80.595 (b) revised..................................................7073
80.607 (a) revised..................................................7073
80.500--80.620 (Subpart I) Removed; eff. 1-1-22....................78467
80.855 (c)(2) revised...............................................7073
80.800--80.1045 (Subpart J) Removed; eff. 1-1-22...................78467
80.1100--80.1167 (Subpart K) Removed; eff. 1-1-22..................78467
80.1240 (a)(1)(i) amended...........................................7073
80.1285 (b) revised.................................................7073
80.1340 (b) revised.................................................7073
80.1200--80.1363 (Subpart L) Removed; eff. 1-1-22..................78467
80.1400 Introductory text amended..................................78467
80.1401 Amended..............................................7073, 78467
80.1405 (a)(11) added; (c) amended..................................7074
80.1407 (f)(9), (10), and (11) added................................7074
80.1407 (e) amended; (f)(7) revised................................78467
80.1408 Added.......................................................7074
80.1415 (c)(4) revised..............................................7075
80.1416 (b)(1)(i) amended..........................................78467
80.1426 Heading, (a)(1)(iii), (2), (c)(4), and (5) revised; (f)(1)
Table 1 amended.............................................7075
80.1427 (b)(2) amended; (c)(2) revised..............................7076
80.1427 (a)(2) introductory text amended; (a)(4) removed...........78467
80.1429 (b)(3) revised..............................................7076
80.1429 (b)(9) introductory text amended; (f) and (g) removed......78467
80.1430 (a), (b)(1), (c), (d)(1), and (e) introductory text
amended; (h) added..........................................7076
80.1431 (b)(2) revised..............................................7076
80.1434 Added.......................................................7076
80.1440 Heading and (a) revised; (f) added..........................7077
80.1440 (a)(2) amended.............................................78467
80.1441 (h) revised.................................................7077
80.1441 (a)(6) and (b)(4) removed..................................78467
80.1442 (i) revised.................................................7077
80.1442 (a)(3) and (b)(6) removed..................................78467
80.1443 (d)(2) revised..............................................7077
80.1449 (d) revised.................................................7077
80.1450 (b) introductory text, (1)(vii)(A)(1), (B), (viii)(A),
(ix)(A) introductory text, (xi)(A), (B), (g)(9), and (h)
revised; (d)(1) amended.....................................7077
80.1450 (a), (b), introductory text, (c), (d)(3)(iii), (e), and
(g)(1) amended.............................................78467
80.1451 (a)(1)(i), (v), (4), (b) introductory text, (1)(ii)(D),
(I), (g)(1)(ii)(D), and (I) revised; (i) and (j)
redesignated as (j) and (k); (a)(1)(xix) and new (i) added
7079
80.1452 (b)(11) revised; (c) introductory text amended..............7079
80.1453 (b) and (d) revised; (e) added..............................7079
80.1453 (e)(1) amended.............................................78467
80.1454 (a) introductory text, (1), (d)(4), (h)(6)(iii), (j)
introductory text, (1), (2) introductory text, (n), and
(q) revised; (t) redesignated as (w); new (t) added.........7080
80.1454 (h)(2)(i) amended..........................................78467
80.1460 (b)(7) and (j) added; (g) revised...........................7080
80.1461 (a)(1) and (2) revised......................................7080
80.1463 (d) revised.................................................7080
[[Page 301]]
80.1464 (a) introductory text, (1)(i)(A), (iii), (iv) introductory
text, (A), (D), and (v) revised; (a)(1)(vii) added;
(b)(1)(ii) amended..........................................7080
80.1464 Introductory text, (a)(1)(iii), (iv)(D), (2)(i),
(b)(1)(iv), (v)(A), (2)(i), and (c)(1)(i) amended..........78467
80.1465 Removed....................................................78467
80.1466 Heading, (a), (b), (c) heading, (1), (d)(1)(iii), (v),
(vi)(B), (3)(ii), (e)(2)(ii), (f) introductory text, (1)
introductory text, (ii)(C), (v)(A), (C), (vii), (2), (4)
through (8), (g), (h) introductory text, (3)(iii), (4),
(i), (j)(2), (3), (4), (k)(1), (2)(ii), (4)(ii), (l)
heading, (1) introductory text, (2)(i), (3), (m)(3)(ii),
(6)(i), (n) introductory text, (1), (3), (4), (o)
introductory text, and (2) revised; (h)(1) amended; (p)
added.......................................................7081
80.1466 (d)(3)(ii), (m)(3) introductory text, (4) introductory
text, (5), (6)(ii), and (iii) amended......................78467
80.1467 (h)(2) and (3) amended.....................................78467
80.1469 (c)(1)(ii) and (f)(1) introductory text revised.............7083
80.1469 (c)(5) amended.............................................78467
80.1472 (b)(3)(i) introductory text, (ii)(B), and (iii) revised.....7083
80.1475 Added.......................................................7083
80.1475 (d)(4)(ii) amended.........................................78468
80.1501 Heading, (b)(3)(i), and (5)(i) revised; (b)(5)(ii) removed
7084
80.1500--80.1509 (Subpart N) Removed; eff. 1-1-22..................78467
80.1600 Amended.....................................................7084
80.1603 (d)(1) revised; (d)(2) redesignated as (d)(3); new (d)(2)
added; (f)(1) amended.......................................7084
80.1609 (a) amended.................................................7084
80.1616 (c)(3) revised..............................................7085
80.1622 (g) revised.................................................7085
80.1625 (c)(2) revised..............................................7085
80.1650 (b)(3), (e)(1)(iii)(A), and (g)(1)(iii)(A) revised..........7085
80.1652 (a)(7) introductory text revised; (a)(7)(v) and (vi) added
7085
80.1656 (h) revised.................................................7085
80.1600--80.1667 (Subpart O) Removed; eff. 1-1-22..................78467
80 Appendixes A and B removed; eff. 1-1-22.........................78467
2021
40 CFR
86 FR
Page
Chapter I
80 Determination....................................................3827
80 Notification....................................................37681
80.1451 (a)(1)(xiv)(E) and (F) added...............................17077
80.1464 (g)(7), (8), and (9) added.................................17078
2022
40 CFR
87 FR
Page
Chapter I
Chapter I Actions on petitions.....................................25412
80.11 Added; eff. 8-30-22..........................................39659
80.1401 Amended; eff. 8-30-22......................................39659
80.1401 Amended....................................................73964
80.1402 Revised; eff. 8-30-22......................................39661
80.1405 (a)(11) revised; (a)(12) and (13) added; eff. 8-30-22......39661
80.1407 (f)(1) revised; eff. 8-30-22...............................39661
80.1408 (a)(2)(i)(B) and (ii)(B) amended; eff. 8-30-22.............39661
80.1415 (c)(2)(ii) and (iii) revised; eff. 8-30-22.................39661
80.1416 (b)(1)(ii) and (iii) revised; eff. 8-30-22.................39662
80.1426 (a)(4), (c)(8), (f)(4)(iv), (17) heading added; (c)(2)
heading and (3) heading removed; (f)(1), (3)(vi), (4)
heading, (5), (7)(v)(A), (B), (8)(ii)(B), (9)(ii), (15)(i)
introductory text, (16)(iii), (17)(i) introductory text,
(B)(1), and (2) revised; table 1, (f)(4)(i)(A)(1) amended;
eff. 8-30-22...............................................39662
80.1426 Table 1 amended............................................73965
80.1428 (b)(2) revised; eff. 8-30-22...............................39664
80.1429 (b)(9) introductory text revised; eff. 8-30-22.............39664
80.1430 (e)(2) revised; eff. 8-30-22...............................39665
80.1431 (a)(3) added; eff. 8-30-22.................................39665
80.1435 (a)(4) amended; eff. 8-30-22...............................39665
80.1444 Added......................................................54166
[[Page 302]]
80.1449 (a)(4)(iii) revised; eff. 8-30-22..........................39665
80.1450 (b) introductory text, (1) introductory text, (i), (ii)
introductory text, (iii), (iv)(A)(1), (2), (B)(3), (v)(B),
(C), (vii)(A) introductory text, (vii)(B) introductory
text, (viii) introductory text, (B)(1), (2), (3), (xii)
introductory text, (B), (C) introductory text, (xiii)(A),
(B) introductory text, (1), (5), (xv) introductory text,
(2)(i)(A), (B), (ii)(A), (B), (C), (iv), (d), (g)(5), (6),
(7), (9), (10)(ii), and (h)(1)(i) revised; (b)(1)(ii)(B),
(xvi), and (g) heading added; (g) introductory text,
(11)(ii), and (h)(2)(i) amended; eff. 8-30-22..............39665
80.1451 (a)(1) introductory text and (f) introductory text
revised; (a)(1)(xiv) removed; (f)(1), (2) heading, and (3)
heading added...............................................5702
80.1451 (b)(1)(ii)(K), (L), (T), (U) introductory text, (g)(1)(i),
(ii) introductory text, (A), (B), (C), (K), (L), (2)(vii)
and (viii) revised; (b)(1)(ii)(R) amended; (g)(2)(x), (j)
and (k) redesignated as (g)(2)(xi), (k) and (l); new
(g)(2)(x), new (j) added; eff. 8-30-22.....................39668
80.1452 (b)(16) redesignated as (b)(18); new (b)(16) and (17)
added; eff. 8-30-22........................................39669
80.1453 (f) added; eff. 8-30-22....................................39669
80.1454 (n) through (q) and (w) removed; (b)(3)(vii) through
(xii), (l)(3), (m)(10), and (s) through (v) redesignated
as (b)(3)(viii) through (xiii), (l)(4), (m)(11) and new
(n) through (q); new (b)(3)(vii), (k) heading, new (l)(3),
new (m)(10), new (s) through (v) added; (b)(6), (i), (j)
introductory text, (l) introductory text, (l)(1), new (n)
introductory text, (r) revised; (d)(4), (m) introductory
text amended; eff. 8-30-22.................................39670
80.1454 (a)(7) added...............................................54166
80.1460 (b)(5) and (6) revised; (b)(8), (k) added; eff. 8-30-22....39671
80.1461 (a)(1) and (2) revised; (e) added; eff. 8-30-22............39671
80.1463 (d) revised; eff. 8-30-22..................................39671
80.1464 (d) revised; (g) and (i) removed............................5702
80.1464 Amended; (a)(3)(ii), (b)(1)(v)(A), (3)(ii), (4)(i), (c)
introductory text, (2)(ii), (i)(1) heading, (i)(1)(i) and
(iii), (i)(2) heading, (i)(2)(i) and (ii) revised; (a)(7),
(b)(1)(v)(C), (4)(iii), (8), (c)(6), (7) and (h) added;
eff. 8-30-22...............................................39671
80.1468 Revised; eff. 8-30-22......................................39673
80.1469 Introductory text, (c)(1)(vi), (vii), (2)(i), (3)(i), (5),
(f)(1) and (2) revised; eff. 8-30-22.......................39673
80.1471 (b)(1), (4), (5), (6), (c), (f)(1) introductory text,
(ii), (g) revised; (e)(5) added; eff. 8-30-22..............39674
80.1472 (a)(4), (b)(3)(i) introductory text, (ii)(B),
(iii)revised; eff. 8-30-22.................................39674
80.1473 (f) amended; eff. 8-30-22..................................39674
80.1474 (b) amended; eff. 8-30-22..................................39674
80.1475 (a)(2), (d)(1), (4) amended; (d)(3) revised eff. 8-30-22
39674
80.1476 Added; eff. 8-30-22........................................39675
80.1477 Added; eff. 8-30-22........................................39675
80.1478 Added; eff. 8-30-22........................................39675
2023
40 CFR
88 FR
Page
Chapter I
80.2 Revised.......................................................44555
80.3 Added.........................................................44562
80.4 Amended.......................................................44562
80.7 (a) introductory text revised; (b) and (c) amended............44562
80.8 Revised.......................................................44563
80.9 Revised.......................................................44563
80.12 Added........................................................44563
80.100--80.185 (Subpart E) Added...................................44564
80.140 Correction: (a) amended.....................................51239
80.1401 Revised....................................................44580
80.1402 (f) amended................................................44580
80.1405 (a) and (c) revised........................................44580
80.1406 Heading revised; (a) removed...............................44581
80.1407 (a)(1) through (4), (b), (d), (e), and (f)(5) amended......44581
[[Page 303]]
80.1415 (b)(2), (6), (c)(1), (2)(ii), and (5) amended; (b)(5) and
(7) revised................................................44581
80.1416 (b)(1)(vii), (2)(vii), (c)(4), and (d) amended.............44582
80.1426 (a)(1) introductory text, (b)(1), (c)(1), (2), (6),
(e)(1), (f)(1)(i), (3)(v), (vi), and (6) introductory text
revised; (a)(1)(iv), (c)(7), (d)(1) introductory text,
(f)(2)(i), (ii), (3)(i) through (iv), (4)(i)(A)(1), (B),
(iv), (5)(iv)(A), (B), (v), (vi), and (6)(i) amended;
Table 1 and Table 2 moved to end of section; (c)(3), Table
3 following (f)(3)(v), and Table 4 following (f)(3)(vi)(A)
removed....................................................44582
80.1426 Correction: (f)(3)(i) and (4)(ii) amended..................51239
80.1427 (a)(1) introductory text amended...........................44584
80.1428 (a) and (b) revised........................................44584
80.1429 Heading, (b)(1), and (10) revised; (a)(1), (2), (b)
introductory text, (6) introductory text, and (c) through
(e) amended; (b)(5) redesignated as (b)(5)(i); (b)(5)(ii)
added......................................................44585
80.1429 Correction: (b)(5) introductory text, (i), and (ii)
redesignated as (b)(5)(i), (i)(A), and (B).................51239
80.1430 (e)(2) amended.............................................44585
80.1431 (a)(1)(vi), (b) introductory text, and (c) introductory
text revised; (a)(1)(viii), (x), and (4) added;
(c)(7)(ii)(P) amended......................................44585
80.1434 (a)(1) and (5) revised; (a)(11) redesignated as (a)(13);
new (a)(11) and (12) added.................................44585
80.1435 (b)(1)(i), (ii), (2)(i) through (iv), and (iii) amended....44586
80.1441 (a)(1) revised; (a)(3) and (b)(3) removed; (e)(1), (2)
introductory text, (ii), (iii), and (g) amended............44586
80.1442 (a)(2), (b)(4), and (5) removed; (c)(1) revised............44586
80.1443 (a), (b), (e) introductory text, and (2) amended...........44586
80.1443 Correction: (a), (b), and (e) introductory text amended....51239
80.1449 (e) amended................................................44586
80.1450 (a), (b)(1)(v) introductory text, (E), (vi), (xi)
introductory text, (A), (B), (xii) introductory text, (2)
introductory text, (iii), (g)(11)(i) through (iii), and
(i)(1) amended; (b)(1) introductory text, (ii), (v)(E),
(xiii)(B) introductory text, (xv)(B), (d)(3), and
(g)(10)(ii) revised; (b)(1)(v)(F), (viii)(E), (xiii)(C),
and (2)(vii) added.........................................44586
80.1450 (b)(2)(ii) revised; (b)(2)(viii) through (x) added.........44587
80.1450 Correction: (b)(1) introductory text, (ii) introductory
text, (g)(11)(i) through (iii), and (i)(1) amended.........51239
80.1451 (a) introductory text, (1)(vi), (xiii), (b), (1)(ii)(O),
(T), (W), (c)(1)(iii)(K), (2)(i)(J), (L), (R),
(2)(ii)(D)(8), (10), (I), (e) introductory text, (h)(2),
(j)(1)(xvi), and (k) amended; (a)(1)(iii), (viii), (ix),
(xvi) through (xviii), (b)(1)(ii)(U) introductory text,
(g) introductory text, (1), (2) introductory text, and
(vii) through (xi) revised; (f)(4) and (g)(2)(xii) added
44588
80.1452 (b)(14), (18), (c)(14), and (d) amended....................44589
80.1453 (a) introductory text, (12) introductory text, and (v)
revised; (a)(12)(viii) and (f)(1)(vii) added; (d) and
(f)(1)(vi) amended.........................................44589
80.1453 Correction: (d) and (f)(1)(vi) amended.....................51240
80.1454 (d) introductory text removed; (d)(1) through (4)
redesignated as (d)(2) through (5); (c)(2)(vii), (3), new
(d)(1), and new (6) added; (a) introductory text, (b)
introductory text, (b)(8), (c)(1) introductory text,
(iii), (2) introductory text, new (d)(2)(ii), new
(4)(ii)(B), (h)(3)(iv), (v), (j)(1)(iii), (2)(iv),
(k)(1)(vii), (l)(4), (m)(11), (t), and (v) amended;
(b)(3)(ix), (xii), new (d)(5), (j) introductory text,
(k)(2), and (l) introductory text revised; (h)(6)(vi) and
(viii) removed.............................................44589
[[Page 304]]
80.1454 Correction: (d) introductory text revised..................51240
80.1455 Removed....................................................44590
80.1457 (b)(8) amended.............................................44590
80.1460 (a), (c)(2), (3), (d), and (g) amended; (l) added..........44591
80.1461 (f) added..................................................44591
80.1464 Introductory text, (a) introductory text, (b)(1)(iii),
(v)(B), (i)(1), and (2) amended............................44591
80.1466 (d)(2)(ii), (f)(1)(viii), (k)(4)(i). (o)(1), and (2)(ii)
amended; (h)(1) and (2) revised............................44591
80.1467 (c)(1)(viii) and (j)(1) amended; (e)(1) and (2) revised....44591
80.1468 Removed....................................................44592
80.1469 (a)(1)(i)(A), (F), (2)(B), (3)(i)(F), (b)(1)(i), (vi),
(2)(ii), (3)(v), (c)(1)(i), (3)(v), (4)(i), and (e)(1)
amended; (c)(4) heading and (d) revised; (c)(6) added......44592
80.1471 (b) introductory text, (1), and (4) through (6) revised;
(b)(2) amended.............................................44592
80.1473 (c)(1), (d)(1), and (e)(1) amended.........................44592
80.1474 (g) amended................................................44592
80.1478 (g)(1) amended.............................................44592
80.1479 Added......................................................44592
2024
(No regulations published from January 1, 2024, through July 1, 2024)
[all]