[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

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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.

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

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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