[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Rules and Regulations]
[Pages 8710-8713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02574]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0230; FRL-10018-73]


Ethaboxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
ethaboxam in or on beet, sugar, roots. Valent U.S.A. LLC., requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective February 9, 2021. Objections and 
requests for hearings must be received on or before April 12, 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-2019-0230, 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,

[[Page 8711]]

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).
     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-2019-0230 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 12, 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-2019-0230, 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 August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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 
9F8747) by Valent U.S.A. LLC, P.O. Box 8025, Walnut Creek, CA 94596-
8025. The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of the fungicide, ethaboxam, (N-
(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-thiazolecarboxamide), 
in or on beet, sugar, root at 0.01 parts per million (ppm). That 
document referenced a summary of the petition prepared by Valent U.S.A. 
LLC, the registrant, which is available in the docket, http://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 has modified the commodity definitions, tolerance levels, 
and tolerances being established. The reasons for these changes are 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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 does not include occupational exposure. 
Section 408(b)(2)(C) of the 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 ethaboxam including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with ethaboxam follows.
    On August 8, 2017, EPA published in the Federal Register a final 
rule establishing tolerances for residues of ethaboxam in or on several 
commodities based on the Agency's conclusion that aggregate exposure to 
ethaboxam is safe for the general population, including infants and 
children. See (82 FR 36086) (FRL-9961-69). EPA is incorporating the 
following portions of that document by reference here, as they have not 
changed in the Agency's current assessment of ethaboxam tolerances: The 
toxicological profile and points of departure; description of the 
assumptions for assessing exposure from residues in or on food, in 
drinking water, and residential exposures; cancer assessment and 
conclusion that a nonlinear reference dose (Rfd) approach is 
appropriate for assessing cancer risk; conclusions about cumulative 
risk; Agency's determination regarding the children's safety factor; 
and tolerance expression, which have not changed. EPA's risk 
assessment, titled

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``Ethaboxam. Human Health Risk Assessment for Non-food Seed 
Treatment,'' supports the tolerances established in March 9, 2012, and 
can be found at http://www.regulations.gov at docket ID EPA-HQ-OPP-
2011-0908-0003. Although the Agency incorporated the assumptions for 
exposure assessment from the March 9, 2012, final rule and risk 
assessment, the Agency conducted a revised risk assessment to 
incorporate exposure to residues of ethaboxam from use as a seed 
treatment on sugar beets. The updated risk assessment, titled 
``Ethaboxam. Human Health Risk Assessment Supporting the Proposed New 
Use on Sugar Beet Seeds,'' is in docket ID number EPA-HQ-OPP-2019-0230.
    EPA's exposure assessments have been updated to include the 
additional exposure from use of ethaboxam on sugar beet, relied on 
tolerance-level residues, an assumption of 100 percent crop treated 
(PCT), and 2018 default processing factors for all processed 
commodities, except for potato, grape, and sugar beet proceeded 
commodities, for which the processing studies demonstrated no 
concentration. EPA's aggregate exposure assessment incorporated this 
additional dietary exposure, which includes exposure through drinking 
water. However, drinking water exposures are not impacted by the new 
use on sugar beet, and thus have not changed since the last assessment. 
Additionally, although sugar beet molasses and dried pulp are 
considered significant livestock feed items, the requested new use on 
sugar beets will not result in the need to establish ethaboxam 
tolerances in livestock commodities.
    An acute dietary risk assessment was not conducted since effects 
attributable to a single exposure were not identified. Chronic dietary 
risks are below the Agency's level of concern: 36% of the chronic 
population adjusted dose (cPAD) for children 1 to 2 years old, the 
group with the highest exposure. Due to no existing registered or 
proposed residential uses associated with ethaboxam, there is not 
expected to be any residential handler exposure or post-application 
dermal exposures. Residential post-application oral and inhalation 
exposures are not expected. Since there are no residential uses, the 
aggregate exposure is equal to the dietary exposure and thus is not of 
concern.
    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 ethaboxam residues. More detailed information on 
the subject action to establish tolerances in or on beet, sugar, roots 
can be found in the document entitled, ``Ethaboxam. Human Health Risk 
Assessment Supporting the Proposed New Use on Sugar Beet Seeds'' by 
going to http://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES. Locate and click on the hyperlink for docket ID number 
EPA-HQ-OPP-2019-0230.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate residue analytical methods for enforcing 
tolerances for ethaboxam residues of concern in/on the registered plant 
commodities. The methods include high-performance liquid chromatography 
with tandem mass-spectrometric detection (LC-MS/MS) for determining 
residues in/on sugar beets.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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).
    The Codex has not established MRLs for ethaboxam in or on beet, 
sugar, roots; however, Canada's Pest Management Regulatory Agency 
(PMRA) is simultaneously evaluating the proposed use for ethaboxam on 
sugar beet seeds. EPA is establishing the same tolerance level for 
beet, sugar, roots as PMRA's proposed MRL of 0.03 ppm. Therefore, there 
are no harmonization issues.

C. Revisions to Petitioned-For Tolerances

    The requested tolerance in ``beet, sugar, root'' was modified to 
read ``beet, sugar, roots'' to be consistent with Agency naming 
practices. The petitioned-for tolerance level of 0.01 ppm in beet, 
sugar, roots has been modified to 0.03 ppm based on the per-trial 
average residue corrected for all field trial dissipation. This is 
consistent with the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedure when all residues 
are corrected for apparent storage stability decline.

V. Conclusion

    Therefore, tolerances are established for residues of ethaboxam in 
or on beet, sugar, roots at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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 tolerance 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

[[Page 8713]]

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.

    Dated: January 15, 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.  180.622, amend paragraph (a) by designating the table and 
adding in alphabetical order in newly designated table 1 to paragraph 
(a) an entry for ``Beet, sugar, roots'' to read as follows:


Sec.  180.622   Ethaboxam; tolerances for residues.

* * * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, roots.........................................         0.03
 
                                * * * * *
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[FR Doc. 2021-02574 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P