[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Rules and Regulations]
[Pages 77999-78002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26014]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0461; FRL-10016-23]


Sethoxydim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
sethoxydim in or on basil, dried leaves and basil, fresh leaves. 
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 3, 2020. Objections and 
requests for hearings must be received on or before February 1, 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-2019-0461, 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 applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).

[[Page 78000]]

     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-2019-0461 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 1, 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-2019-0461, 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 October 3, 2019 (84 FR 52850) (FRL-9999-
89), 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 
9E8769) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.412 be 
amended by establishing tolerances for residues of the herbicide 
sethoxydim, including its metabolites and degradates, determined by 
measuring only the sum of sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-
2) and its metabolites containing the 2-cyclohexen-1-one moiety, 
calculated as the stoichiometric equivalent of sethoxydim, in or on 
basil, dried leaves at 20 parts per million (ppm) and basil, fresh 
leaves at 8 ppm. That document referenced a summary of the petition 
prepared by IR-4, the petitioner, which is available in the docket for 
this action, docket ID number EPA-HQ-OPP-2019-0461, at http://www.regulations.gov. No relevant comments were received in response to 
the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

A. Statutory Background

    Section 408(b)(2)(A)(i) of the 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 it 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), 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 
sethoxydim and to make a determination on aggregate exposure for 
sethoxydim, including exposure resulting from the tolerances 
established by this action. EPA's assessment of exposures and risks 
associated with sethoxydim follows.

B. Sethoxydim Aggregate Risk Assessment

    On June 15, 2015, EPA published in the Federal Register a final 
rule establishing tolerances for residues of sethoxydim in or on 
multiple commodities based on the Agency's conclusion that aggregate 
exposure to sethoxydim is safe for the general population, including 
infants and children. See 80 FR 34070 (FRL-9928-20) (Docket ID EPA-HQ-
OPP-2014-0161). In an effort to streamline Federal Register 
publications, EPA is not reprinting here summaries of its analysis that 
have previously appeared in the Federal Register in tolerance 
rulemakings for the same pesticide. To that end, this rulemaking refers 
the reader to the following sections from the June 15, 2015 tolerance 
rulemaking for sethoxydim that remain unchanged for an understanding of 
the Agency's rationale in support of this rulemaking: Units III.A 
(Toxicological Profile); III.B. (Toxicological Points of Departure/
Levels of Concern); III.C. (Exposure Assessment), except as explained 
in the next paragraphs; III.D. (Safety Factor for Infants and 
Children); and IV.A (Analytical Enforcement Method).
    1. Updates to exposure assessment. EPA's dietary (food and drinking 
water) exposure assessments have been updated to include the additional 
exposure from the new use of sethoxydim on basil. In addition, the 
acute dietary exposure assessment was revised to: (1) Assume 100% crop 
treated, instead of using percent crop treated as described in the 2015 
rule; and (2) incorporate empirical and/or EPA's 2018 default 
processing factors. The assumption of tolerance-level residues for both 
the acute and chronic dietary analyses has not changed. For the chronic 
dietary exposure assessment, EPA incorporated updated average crop 
treated estimates for select commodities and EPA's 2018 processing 
factors.
    The new use on basil does not impact drinking water exposures; 
therefore, the Agency relied on the same values for drinking water 
exposures as expressed in the June 2015 rulemaking.
    While EPA has updated the human equivalent doses for assessing

[[Page 78001]]

inhalation risk to residential handlers, this revision does not impact 
the approach of the aggregate assessment. The scenario and life stage 
resulting in the highest residential exposures for use in the aggregate 
assessment and which is considered protective of other exposure 
scenarios continues to be the post-application incidental oral hand-to-
mouth exposure of children (1 to less than 2 years old) on treated 
turf. The new use on basil does not result in any additional 
residential exposures.
    2. Assessment of aggregate risks. EPA determines whether acute and 
chronic dietary pesticide exposures are safe by comparing aggregate 
exposure estimates to the acute population adjusted dose and chronic 
population adjusted dose. 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 (food and drinking water) risks are below the 
Agency's level of concern of 100% of the acute population adjusted dose 
(aPAD): They are less than 12% of the aPAD for children 1 to 2 years 
old, the population subgroup with the highest exposure estimate. 
Chronic dietary risks are below the Agency's level of concern of 100% 
of the chronic population adjusted dose (cPAD): They are 24% of the 
cPAD for children 1 to 2 years old, the population subgroup with the 
highest exposure estimate.
    For the aggregate risk assessment, exposures to sethoxydim in food 
and drinking water are combined with residential exposures for the 
relevant exposure duration period. Aggregate acute and chronic risk are 
equivalent to the dietary risks, which are below EPA's level of 
concern, because neither acute nor long-term residential exposures are 
expected.
    The short-term aggregate risk assessment considers only residential 
incidental oral exposures and combines chronic (background) exposures 
with the expected short-term post-application exposures to children 1 
to 2 years old. This yields an MOE of 4,400, which is not of concern 
because it exceeds EPA's level of concern (MOEs less than or equal to 
100). Intermediate-term residential exposures are not expected.
    Finally, as stated in the June 2015 rulemaking, sethoxydim is not 
expected to pose a cancer risk to humans.

C. Determination of Safety

    Therefore, based on the risk assessments and information described 
and referenced above, EPA concludes that there is a reasonable 
certainty that no harm will result to the general population, or to 
infants and children, from aggregate exposure to sethoxydim residues. 
More detailed information about the Agency's analysis can be found in 
``Sethoxydim: Human Health Risk Assessment to Support the Section 3 Use 
on Basil and a Label Amendment to Reduce the Pre-harvest Interval for 
Caneberry Subgroup 13-07A'' dated October 21, 2020 in docket ID number 
EPA-HQ-OPP-2019-0461.

IV. 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).
    The Codex has not established a MRL for sethoxydim.

V. Conclusion

    Therefore, tolerances are established for residues of sethoxydim, 
including its metabolites and degradates, determined by measuring only 
the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-
2) and its metabolites containing the 2-cyclohexen-1-one moiety, 
calculated as the stoichiometric equivalent of sethoxydim, in or on 
basil, dried leaves at 20 ppm and basil, fresh leaves at 8 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 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

[[Page 78002]]

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: November 5, 2020.
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.  180.412, amend paragraph (a) by designating the table and 
adding in alphabetical order in newly designated Table 1 to paragraph 
(a) the entries ``Basil, dried leaves'' and ``Basil, fresh leaves'' to 
read as follows:


Sec.  180.412  Sethoxydim; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Basil, dried leaves.........................................          20
Basil, fresh leaves.........................................           8
 
                                * * * * *
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* * * * *
[FR Doc. 2020-26014 Filed 12-2-20; 8:45 am]
BILLING CODE 6560-50-P