[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Rules and Regulations]
[Pages 9859-9862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03172]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0641; FRL-10017-26]


Clopyralid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
clopyralid in or on the caneberry subgroup 13-07A, the bulb onion 
subgroup 3-07A, and intermediate wheatgrass bran, forage, germ, grain, 
middling, shorts, and straw. Interregional Research Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 17, 2021. Objections and 
requests for hearings must be received on or before April 19, 2021, 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-2019-0641, is available at http://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 related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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

[[Page 9860]]

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 Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2019-0641 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 
April 19, 2021. 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-2019-0641, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting 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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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 
9E8794) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested that EPA establish tolerances in 40 
CFR 180.431 for residues of the herbicide clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) in or on the raw agricultural commodities 
Onion, bulb, subgroup 3-07A at 0.4 parts per million (ppm); Caneberry 
subgroup 13-07A at 0.1 ppm; Wheatgrass, intermediate, bran at 12 ppm; 
Wheatgrass, intermediate, forage at 9 ppm; Wheatgrass, intermediate, 
germ at 12 ppm; Wheatgrass, intermediate, grain at 3 ppm; Wheatgrass, 
intermediate, middling at 12 ppm; Wheatgrass, intermediate, shorts at 
12 ppm; Wheatgrass, intermediate, straw at 9 ppm. That document 
referenced a summary of the petition prepared by Corteva, the 
registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the 
notice of filing.

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 in FFDCA section 408(b)(2)(D), 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 clopyralid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with clopyralid 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 rulemakings of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings and republishing the same sections is 
unnecessary; 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 number of tolerance rulemakings for 
clopyralid, in which EPA concluded, based on the available information, 
that there is a reasonable certainty that no harm would result from 
aggregate exposure to clopyralid and established tolerances for 
residues of that chemical. EPA is incorporating previously published 
sections from those rulemakings as described further in this 
rulemaking, as they remain unchanged.
    Toxicological Profile. For a discussion of the Toxicological 
Profile of clopyralid, see Unit III.A. of the May 23, 2018 rulemaking 
(83 FR 23819) (FRL-9977-13).
    Toxicological Points of Departure/Levels of Concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern used for the 
safety assessment, see Unit III.B. of the May 23, 2018 rulemaking.
    Exposure Assessment. Much of the exposure assessment remains the 
same, although updates have occurred to accommodate exposures from the 
petitioned-for tolerances. The updates are discussed in this section; 
the remaining discussion of EPA's assumptions for exposure remain 
unchanged since the 2018 rulemaking. For a description of the rest of 
the EPA approach to and assumptions for the exposure assessment, see 
Unit III.C. of the May 23, 2018 rulemaking.

[[Page 9861]]

    Safety Factor for Infants and Children. EPA continues to conclude 
that there is reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the May 
23, 2018 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 PAD (cPAD). Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs 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.
    No acute effects were identified in the toxicological studies for 
clopyralid; therefore, acute risk is not expected. Chronic dietary 
risks are below the Agency's level of concern of 100% of the cPAD: They 
are 30% of the cPAD for children 1 to 2 years old, the population 
subgroup with the highest exposure estimate. The short-term MOE is 
greater than the Agency's level of concern of 100: It is 1,400 for 
children 1 to less than 2 years old, the population group of concern. 
Intermediate-term or long-term residential exposures are not expected.
    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 clopyralid residues. More detailed information 
about the Agency's analysis can be found at http://www.regulations.gov 
in the document titled ``Clopyralid. Human Health Risk Assessment for a 
Proposed Use on Bulb Onion Subgroup (3-07B), Caneberry Subgroup (13-
07A), Wheatgrass, and a Label Amendment for Strawberry'' in docket ID 
number EPA-HQ-OPP-2019-0641.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual Volume II (PAM II) lists a method 
utilizing gas chromatography with electron capture detection (GC/ECD) 
for determination of clopyralid residues in plant commodities (Method I 
or Method ACR 75.6).

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). No Codex MRLs have been established for clopyralid.

V. Conclusion

    Therefore, tolerances are established for residues of clopyralid in 
or on the Caneberry subgroup 13-07A at 0.1 ppm; Onion, bulb, subgroup 
3-07A at 0.4 ppm; Wheatgrass, intermediate, bran at 12 ppm; Wheatgrass, 
intermediate, forage at 9 ppm; Wheatgrass, intermediate, germ at 12 
ppm; Wheatgrass, intermediate, grain at 3 ppm; Wheatgrass, 
intermediate, middling at 12 ppm; Wheatgrass, intermediate, shorts at 
12 ppm; and Wheatgrass, intermediate, straw at 9 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes 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 Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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 and 
modifications 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

    Pursuant to the Congressional Review Act (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.


[[Page 9862]]


    Dated: February 3, 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 I 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. In Sec.  180.431, amend paragraph (a) by designating the table and 
adding in alphabetical order in newly designated Table 1 to paragraph 
(a) the entries ``Caneberry subgroup 13-07A''; ``Onion, bulb, subgroup 
3-07A''; ``Wheatgrass, intermediate, bran''; ``Wheatgrass, 
intermediate, forage''; ``Wheatgrass, intermediate, germ''; 
``Wheatgrass, intermediate, grain''; ``Wheatgrass, intermediate, 
middling''; ``Wheatgrass, intermediate, shorts''; and ``Wheatgrass, 
intermediate, straw'' to read as follows:


Sec.  180.431  Clopyralid; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Caneberry subgroup 13-07A...................................         0.1
 
                                * * * * *
Onion, bulb, subgroup 3-07A.................................         0.4
 
                                * * * * *
Wheatgrass, intermediate, bran..............................          12
 
                                * * * * *
Wheatgrass, intermediate, forage............................           9
 
                                * * * * *
Wheatgrass, intermediate, germ..............................          12
 
                                * * * * *
Wheatgrass, intermediate, grain.............................           3
 
                                * * * * *
Wheatgrass, intermediate, middling..........................          12
 
                                * * * * *
Wheatgrass, intermediate, shorts............................          12
 
                                * * * * *
Wheatgrass, intermediate, straw.............................           9
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[FR Doc. 2021-03172 Filed 2-16-21; 8:45 am]
BILLING CODE 6560-50-P