MCPA; Pesticide Tolerances, 71152-71155 [2021-27134]
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Federal Register / Vol. 86, No. 238 / Wednesday, December 15, 2021 / Rules and Regulations
National Environmental Policy Act
This rulemaking does not constitute a
major Federal action significantly
affecting the quality of the human
environment. A detailed statement
under the National Environmental
Policy Act of 1969 (NEPA) is not
required because the rulemaking is
covered by a categorical exclusion. The
NPS has determined the rule is
categorically excluded under 43 CFR
46.210(i). The environmental effects of
removing 36 CFR 7.1(a) are too broad,
speculative, or conjectural to lend
themselves to meaningful analysis.
Decisions to construct and designate
launching and retrieval sites will later
be subject to the NEPA process, either
collectively or case-by-case. The nature
of the proposal to remove 36 CFR 7.1(b)
is administrative, financial and legal.
The NPS has determined the rulemaking
does not involve any of the
extraordinary circumstances listed in 43
CFR 46.215 that would require further
analysis under NEPA.
Effects on the Energy Supply (Executive
Order 13211)
This rulemaking is not a significant
energy action under the definition in
Executive Order 13211. The rule is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy, and the rule has not otherwise
been designated by the Administrator of
OIRA as a significant energy action. A
Statement of Energy Effects in not
required.
List of Subjects in 36 CFR Part 7
District of Columbia, National parks,
Reporting and Recordkeeping
requirements.
In consideration of the foregoing, the
National Park Service amends 36 CFR
part 7 as set forth below:
PART 7—SPECIAL REGULATIONS,
AREAS OF THE NATIONAL PARK
SYSTEM
1. The authority citation for part 7
continues to read as follows:
■
Authority: 54 U.S.C. 100101, 100751,
320102; Sec. 7.96 also issued under D.C.
Code 10–137 and D.C. Code 50–2201.07.
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§ 7.1
■
2. Remove and reserve § 7.1.
Shannon A. Estenoz,
Assistant Secretary for Fish and Wildlife and
Parks.
16:21 Dec 14, 2021
[EPA–HQ–OPP–2020–0691; FRL–9273–01–
OCSPP]
MCPA; Pesticide Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
This regulation modifies
existing tolerances for residues of MCPA
in or on clover, forage and clover, hay.
The Interregional Research Project
Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
SUMMARY:
This regulation is effective
December 15, 2021. Objections and
requests for hearings must be received
on or before February 14, 2022 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0691, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Due to the public health emergency,
the EPA Docket Center (EPA/DC) and
Reading Room is closed to visitors with
limited exceptions. The staff continues
to provide customer service via email,
phone, and webform. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
ADDRESSES:
Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4312–52–P
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40 CFR Part 180
FOR FURTHER INFORMATION CONTACT:
[Removed and Reserved]
[FR Doc. 2021–27138 Filed 12–14–21; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2020–0691 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 14, 2022. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2020–0691, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
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comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of June 28,
2021 (86 FR 33922) (FRL–10025–08)
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 0E8864) by IR–4,
North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210,
Raleigh, NC 27606. The petition
requested that 40 CFR 180.339 be
amended by revising tolerances for
residues of the herbicide MCPA ((4chloro-2-methylphenoxy)acetic acid),
both free and conjugated, resulting from
the direct application of MCPA or its
sodium, dimethylamine salts or its 2ethylhexyl ester in or on the raw
agricultural commodities clover, forage
at 0.1 parts per million (ppm), and
clover, hay at 0.1 ppm. The petitionedfor tolerances are lower than the
existing tolerances for these
commodities due to the results from
clover residue data that were generated
by IR–4 which indicated that lower
tolerances were appropriate for clover,
forage and clover, hay. Previously, no
clover-specific data had been generated.
That document referenced a summary of
the petition, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA is
establishing the tolerances at different
levels than petitioned for. Additionally,
the tolerance expression is being
modified to be consistent with Agency
policy. A discussion of these
modifications can be found in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
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residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified
therein, EPA has reviewed the available
scientific data and other relevant
information in support of this action.
EPA has sufficient data to assess the
hazards of and to make a determination
on aggregate exposure for MCPA
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with MCPA follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections that
repeat what has been previously
published for tolerance rulemaking of
the same pesticide chemical. Where
scientific information concerning a
particular chemical remains unchanged,
the content of those sections would not
vary between tolerance rulemaking, and
EPA considers referral back to those
sections as sufficient to provide an
explanation of the information EPA
considered in making its safety
determination for the new rulemaking.
EPA has previously published a
tolerance rulemaking for MCPA in
which EPA concluded, based on the
available information, that there is a
reasonable certainty that no harm would
result from aggregate exposure to MCPA
and established tolerances for residues
of that chemical. EPA is incorporating
previously published sections from that
rulemaking as described further in this
rulemaking, as they remain unchanged.
Toxicological profile. For a discussion
of the Toxicological Profile of MCPA,
see Unit III.A. of the MCPA tolerance
rulemaking published in the Federal
Register of April 13, 2021 (86 FR 19145)
(FRL–10020–79).
Toxicological points of departure/
Levels of concern. For a summary of the
Toxicological Points of Departure/
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Levels of Concern for MCPA used for
human risk assessment, please reference
Unit III.B. of the April 13, 2021
rulemaking.
Exposure assessment. The new use on
clover does not impact the dietary
assessment, because the clover use does
not result in a significant increase in
dietary exposure. For a description of
the approach to and assumptions for the
exposure assessment, including with
respect to estimated drinking water
concentrations, non-occupational
exposure, and cumulative exposure,
please reference Unit III.C. of the April
13, 2021 rulemaking.
Safety factor for infants and children.
EPA continues to conclude that there
are reliable data to support the
reduction of the Food Quality Protection
Act (FQPA) safety factor from 10X to
1X, except for acute dietary (general
population, including infants and
children) and inhalation scenarios
where a 10X safety factor is retained as
a lowest-observed-adverse-effect-level
(LOAEL) to no-observed-adverse-effectlevel (NOAEL) extrapolation factor. See
Unit III.D. of the April 13, 2021
rulemaking for a discussion of the
Agency’s rationale for that
determination.
Aggregate risks and determination of
safety. EPA determines whether acute
and chronic dietary pesticide exposures
are safe by comparing aggregate
exposure estimates to the acute
population adjusted dose (aPAD) and
chronic population adjusted dose
(cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by
comparing the estimated aggregate food,
water, and residential exposure to the
appropriate points of departure to
ensure that an adequate margin of
exposure (MOE) exists. For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure.
Acute dietary risks are below the
Agency’s level of concern of 100% of
the aPAD; they are 29% of the aPAD for
all infants less than 1 year old, the
group with the highest exposure.
Chronic dietary risks are below the
Agency’s level of concern of 100% of
the cPAD; they are 28% of the cPAD for
all infants less than 1 year old, the
group with the highest exposure. EPA
has concluded the combined short-term
food, water, and residential exposures
result in aggregate margins of exposure
at or above the level of concern of 100
for all scenarios assessed and are not of
concern. An intermediate-term adverse
effect was identified; however, MCPA is
not registered for any use patterns that
would result in intermediate-term
residential exposure. EPA relies on the
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chronic dietary risk assessment for
evaluating intermediate-term risk for
MCPA, which is below the Agency’s
level of concern. MCPA is classified as
‘‘Not Likely to Be Carcinogenic to
Humans’’; therefore, EPA does not
expect MCPA exposures to pose an
aggregate cancer risk.
Therefore, based on the risk
assessments and information described
above, EPA concludes there is a
reasonable certainty that no harm will
result to the general population, or to
infants and children, from aggregate
exposure to MCPA residues. More
detailed information on this action can
be found in the document titled
‘‘MCPA. Human Health Risk
Assessment in Support of a Section 3
Registration for Use of MCPA on
Clover’’ in docket ID EPA–HQ–OPP–
2020–0691.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the April 13, 2021 rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
Currently, there are no Codex MRLs
for residues of MCPA in or on clover.
Therefore, harmonization is not an
issue.
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C. Revisions to Petitioned-For
Tolerances
All residues at or below the limit of
quantitation (LOQ) equate to a
recommended LOQ tolerance level of
0.05 ppm for both clover, forage and
clover, hay, as opposed to the tolerances
that were proposed (0.1 ppm for both
clover, forage and clover, hay). The
tolerances include residues of parent
(MCPA) and metabolite 2-HMCPA [(4chloro-2-hydroxymethylphenoxy)acetic
acid]. However, MCPA is the only
residue of concern for tolerance
enforcement purposes. In addition, EPA
is modifying the tolerance expression to
use the Chemical Abstracts Service
(CAS) name for consistency with other
tolerance expressions.
Finally, EPA has revised the tolerance
expression to clarify (1) that, as
provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
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degradates of MCPA not specifically
mentioned; and (2) that compliance
with the specified tolerance levels is to
be determined by measuring only the
specific compound mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are modified for
residues of MCPA in or on Clover,
forage from 0.5 ppm to 0.05 ppm, and
Clover, hay from 2.0 ppm to 0.05 ppm
and the tolerance expression is updated.
VI. Statutory and Executive Order
Reviews
This action modifies tolerances under
FFDCA section 408(d) in response to a
petition submitted to the Agency. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001), or to
Executive Order 13045, entitled
‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997).
This action does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994). Since tolerances and exemptions
that are established on the basis of a
petition under FFDCA section 408(d),
such as the tolerances in this final rule,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
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various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et
seq.), EPA will submit a report
containing this rule and other required
information to the U.S. Senate, the U.S.
House of Representatives, and the
Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides,
and pests, Reporting and recordkeeping
requirements.
Dated: December 9, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter 1 as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.339, to read as
follows:
■
§ 180.339
MCPA; tolerances for residues.
(a) General. Tolerances are
established for residues of the herbicide
MCPA, including its metabolites and
degradates, in or on the commodities in
table 1 to this paragraph (a). Compliance
with the tolerance levels specified in
Table 1 to this paragraph (a) is to be
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determined by measuring only MCPA,
2-(4-chloro-2-methylphenoxy)acetic
acid, in or on the commodity.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
TABLE 1 TO PARAGRAPH (a)
Parts per
million
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Commodity
Alfalfa, forage .............................
Alfalfa, hay ..................................
Barley, grain ...............................
Barley, hay ..................................
Barley, straw ...............................
Cattle, fat ....................................
Cattle, meat ................................
Cattle, meat byproducts .............
Clover, forage .............................
Clover, hay .................................
Flax, seed ...................................
Goat, fat ......................................
Goat, meat ..................................
Goat, meat byproducts ...............
Grain, aspirated fractions ...........
Grass, forage ..............................
Grass, hay ..................................
Hog, fat .......................................
Hog, meat ...................................
Hog, meat byproducts ................
Horse, fat ....................................
Horse, meat ................................
Horse, meat byproducts .............
Lespedeza, forage ......................
Lespedeza, hay ..........................
Milk .............................................
Oat, forage ..................................
Oat, grain ....................................
Oat, hay ......................................
Oat, straw ...................................
Pea, dry ......................................
Pea, field, hay .............................
Pea, field, vines ..........................
Pea, succulent ............................
Rye, forage .................................
Rye, grain ...................................
Rye, straw ...................................
Sheep meat ................................
Sheep meat byproducts .............
Sheep, fat ...................................
Tea, dried ...................................
Trefoil, forage .............................
Trefoil, hay ..................................
Vetch, forage ..............................
Vetch, hay ...................................
Wheat, forage .............................
Wheat, grain ...............................
Wheat, hay .................................
Wheat, straw ...............................
Wheatgrass, intermediate, forage ..........................................
Wheatgrass, intermediate, grain
Wheatgrass, intermediate, hay ...
Wheatgrass, intermediate, straw
(b)–(d) [Reserved]
[FR Doc. 2021–27134 Filed 12–14–21; 8:45 am]
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0.5
2.0
1.0
40
25
0.1
0.1
0.1
0.05
0.05
0.1
0.1
0.1
0.1
3.0
300
20
0.1
0.1
0.1
0.1
0.1
0.1
0.5
2.0
0.1
20
1.0
115
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0.1
0.1
0.1
0.1
20
1.0
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1.0
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25
[EPA–HQ–OPP–2020–0538; FRL–9194–01–
OSCPP]
Mefentrifluconazole; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
This regulation establishes
tolerances for residues of
mefentrifluconazole in or on banana and
coffee, green bean. BASF Corporation
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
December 15, 2021. Objections and
requests for hearings must be received
on or before February 14, 2022 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0538, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Due to the public health concerns
relating to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide customer service via email,
phone, and webform. For the latest
status information on EPA/DC services,
docket access, visit https://
50 www.epa.gov/dockets.
0.2 FOR FURTHER INFORMATION CONTACT:
50 Marietta Echeverria, Registration
50 Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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71155
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2020–0538 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 14, 2022. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2020–0538, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
E:\FR\FM\15DER1.SGM
15DER1
]]>Agencies
[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71152-71155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27134]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0691; FRL-9273-01-OCSPP]
MCPA; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation modifies existing tolerances for residues of
MCPA in or on clover, forage and clover, hay. The Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 15, 2021. Objections and
requests for hearings must be received on or before February 14, 2022
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0691, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide customer service via email, phone, and
webform. For the latest status information on EPA/DC services, docket
access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0691 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 14, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0691, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting
[[Page 71153]]
comments. Do not submit electronically any information you consider to
be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08) EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0E8864) by IR-4, North Carolina State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that
40 CFR 180.339 be amended by revising tolerances for residues of the
herbicide MCPA ((4-chloro-2-methylphenoxy)acetic acid), both free and
conjugated, resulting from the direct application of MCPA or its
sodium, dimethylamine salts or its 2-ethylhexyl ester in or on the raw
agricultural commodities clover, forage at 0.1 parts per million (ppm),
and clover, hay at 0.1 ppm. The petitioned-for tolerances are lower
than the existing tolerances for these commodities due to the results
from clover residue data that were generated by IR-4 which indicated
that lower tolerances were appropriate for clover, forage and clover,
hay. Previously, no clover-specific data had been generated. That
document referenced a summary of the petition, which is available in
the docket, https://www.regulations.gov. There were no comments
received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing the tolerances at different levels than petitioned for.
Additionally, the tolerance expression is being modified to be
consistent with Agency policy. A discussion of these modifications can
be found in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for MCPA including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with MCPA follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published a tolerance rulemaking for MCPA in
which EPA concluded, based on the available information, that there is
a reasonable certainty that no harm would result from aggregate
exposure to MCPA and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from that
rulemaking as described further in this rulemaking, as they remain
unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of MCPA, see Unit III.A. of the MCPA tolerance rulemaking
published in the Federal Register of April 13, 2021 (86 FR 19145) (FRL-
10020-79).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for MCPA
used for human risk assessment, please reference Unit III.B. of the
April 13, 2021 rulemaking.
Exposure assessment. The new use on clover does not impact the
dietary assessment, because the clover use does not result in a
significant increase in dietary exposure. For a description of the
approach to and assumptions for the exposure assessment, including with
respect to estimated drinking water concentrations, non-occupational
exposure, and cumulative exposure, please reference Unit III.C. of the
April 13, 2021 rulemaking.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X, except for
acute dietary (general population, including infants and children) and
inhalation scenarios where a 10X safety factor is retained as a lowest-
observed-adverse-effect-level (LOAEL) to no-observed-adverse-effect-
level (NOAEL) extrapolation factor. See Unit III.D. of the April 13,
2021 rulemaking for a discussion of the Agency's rationale for that
determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic population adjusted dose (cPAD). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 29% of the aPAD for all infants less than 1 year
old, the group with the highest exposure. Chronic dietary risks are
below the Agency's level of concern of 100% of the cPAD; they are 28%
of the cPAD for all infants less than 1 year old, the group with the
highest exposure. EPA has concluded the combined short-term food,
water, and residential exposures result in aggregate margins of
exposure at or above the level of concern of 100 for all scenarios
assessed and are not of concern. An intermediate-term adverse effect
was identified; however, MCPA is not registered for any use patterns
that would result in intermediate-term residential exposure. EPA relies
on the
[[Page 71154]]
chronic dietary risk assessment for evaluating intermediate-term risk
for MCPA, which is below the Agency's level of concern. MCPA is
classified as ``Not Likely to Be Carcinogenic to Humans''; therefore,
EPA does not expect MCPA exposures to pose an aggregate cancer risk.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to MCPA residues. More detailed information on this
action can be found in the document titled ``MCPA. Human Health Risk
Assessment in Support of a Section 3 Registration for Use of MCPA on
Clover'' in docket ID EPA-HQ-OPP-2020-0691.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the April 13, 2021 rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
Currently, there are no Codex MRLs for residues of MCPA in or on
clover. Therefore, harmonization is not an issue.
C. Revisions to Petitioned-For Tolerances
All residues at or below the limit of quantitation (LOQ) equate to
a recommended LOQ tolerance level of 0.05 ppm for both clover, forage
and clover, hay, as opposed to the tolerances that were proposed (0.1
ppm for both clover, forage and clover, hay). The tolerances include
residues of parent (MCPA) and metabolite 2-HMCPA [(4-chloro-2-
hydroxymethylphenoxy)acetic acid]. However, MCPA is the only residue of
concern for tolerance enforcement purposes. In addition, EPA is
modifying the tolerance expression to use the Chemical Abstracts
Service (CAS) name for consistency with other tolerance expressions.
Finally, EPA has revised the tolerance expression to clarify (1)
that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of MCPA not specifically mentioned; and (2)
that compliance with the specified tolerance levels is to be determined
by measuring only the specific compound mentioned in the tolerance
expression.
V. Conclusion
Therefore, tolerances are modified for residues of MCPA in or on
Clover, forage from 0.5 ppm to 0.05 ppm, and Clover, hay from 2.0 ppm
to 0.05 ppm and the tolerance expression is updated.
VI. Statutory and Executive Order Reviews
This action modifies tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994). Since tolerances and exemptions that are established on the
basis of a petition under FFDCA section 408(d), such as the tolerances
in this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides, and pests, Reporting and
recordkeeping requirements.
Dated: December 9, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Revise Sec. 180.339, to read as follows:
Sec. 180.339 MCPA; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide MCPA, including its metabolites and degradates, in or on the
commodities in table 1 to this paragraph (a). Compliance with the
tolerance levels specified in Table 1 to this paragraph (a) is to be
[[Page 71155]]
determined by measuring only MCPA, 2-(4-chloro-2-methylphenoxy)acetic
acid, in or on the commodity.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................. 0.5
Alfalfa, hay................................................ 2.0
Barley, grain............................................... 1.0
Barley, hay................................................. 40
Barley, straw............................................... 25
Cattle, fat................................................. 0.1
Cattle, meat................................................ 0.1
Cattle, meat byproducts..................................... 0.1
Clover, forage.............................................. 0.05
Clover, hay................................................. 0.05
Flax, seed.................................................. 0.1
Goat, fat................................................... 0.1
Goat, meat.................................................. 0.1
Goat, meat byproducts....................................... 0.1
Grain, aspirated fractions.................................. 3.0
Grass, forage............................................... 300
Grass, hay.................................................. 20
Hog, fat.................................................... 0.1
Hog, meat................................................... 0.1
Hog, meat byproducts........................................ 0.1
Horse, fat.................................................. 0.1
Horse, meat................................................. 0.1
Horse, meat byproducts...................................... 0.1
Lespedeza, forage........................................... 0.5
Lespedeza, hay.............................................. 2.0
Milk........................................................ 0.1
Oat, forage................................................. 20
Oat, grain.................................................. 1.0
Oat, hay.................................................... 115
Oat, straw.................................................. 25
Pea, dry.................................................... 0.1
Pea, field, hay............................................. 0.1
Pea, field, vines........................................... 0.1
Pea, succulent.............................................. 0.1
Rye, forage................................................. 20
Rye, grain.................................................. 1.0
Rye, straw.................................................. 25
Sheep meat.................................................. 0.1
Sheep meat byproducts....................................... 0.1
Sheep, fat.................................................. 0.1
Tea, dried.................................................. 0.3
Trefoil, forage............................................. 0.5
Trefoil, hay................................................ 2.0
Vetch, forage............................................... 0.5
Vetch, hay.................................................. 2.0
Wheat, forage............................................... 20
Wheat, grain................................................ 1.0
Wheat, hay.................................................. 115
Wheat, straw................................................ 25
Wheatgrass, intermediate, forage............................ 50
Wheatgrass, intermediate, grain............................. 0.2
Wheatgrass, intermediate, hay............................... 50
Wheatgrass, intermediate, straw............................. 50
------------------------------------------------------------------------
(b)-(d) [Reserved]
[FR Doc. 2021-27134 Filed 12-14-21; 8:45 am]
BILLING CODE 6560-50-P
