[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Rules and Regulations]
[Pages 43697-43699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14394]



40 CFR Part 180

[EPA-HQ-OPP-2017-0155 and EPA-HQ-OPP-2019-0383; FRL-10008-84]

Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation amends the existing tolerances for residues of 
the ovicide/miticide hexythiazox in or on Caneberry, Subgroup 13-07A, 
by increasing the current tolerance from 1 part per million (ppm) to 3 
ppm; and on Date, dried, by increasing the current tolerance from 1.0 
ppm to 3 ppm. This regulation also establishes a tolerance for residues 
of the ovicide/miticide hexythiazox in or on Tea, dried at 15 ppm. 
Gowan Company and the Tea Association of the USA, Inc. requested these 
tolerances and tolerance revisions under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a.

DATES: This regulation is effective July 20, 2020. Objections and 
requests for hearings must be received on or before September 18, 2020, 
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 dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2017-0155 and EPA-HQ-OPP-2019-
0383, are 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.
    Please note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].


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 numbers EPA-HQ-OPP-2017-0155 and EPA-HQ-OPP-2019-0383 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 September 18, 2020. Addresses for mail and 
hand delivery of objections and hearing requests are provided in 40 CFR 
    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 numbers EPA-HQ-OPP-2017-0155 and EPA-
HQ-OPP-2019-0383, 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 
     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 February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a

[[Page 43698]]

pesticide petition (PP 9F8737) by Gowan Company, P.O. Box 5569, Yuma, 
AZ 85366-5569. The petition requested that 40 CFR 180.448 be amended by 
increasing the existing tolerances for residues of the ovicide/miticide 
hexythiazox, (4R,5R)-rel-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-
oxo-3-thiazolidinecarboxamide, in or on caneberry, subgroup 13-07A to 
3.0 parts per million (ppm) and date, dried to 3.0 ppm.
    In addition, in the Federal Register of August 30, 2019 (84 FR 
45702) (FRL-9998-15), EPA issued another document pursuant to FFDCA 
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a 
pesticide petition (PP 9E8756) by the Tea Association of the USA, Inc., 
362 5th Avenue, Suite 1002, New York, NY 10001-2251. This petition 
requested that 40 CFR part 180.448 be amended by establishing 
tolerances for residues of the ovicide/miticide hexythiazox, (4R,5R)-
thiazolidinecarboxamide, in or on tea, dried at 15.0 ppm.
    These documents referenced summaries of the petitions prepared by 
the Gowan Company and the Tea Association of the USA, Inc., which are 
available in the referenced dockets, http://www.regulations.gov. There 
were no substantive comments received in response to either notice of 

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 hexythiazox including exposure 
resulting from the tolerances established by this action. A summary of 
EPA's assessment of exposures and risks associated with hexythiazox 
    In the Federal Register on October 30, 2017 (82 FR 50084) (FRL-
9968-12), EPA published a final rule amending an existing tolerance for 
residues of the ovicide/miticide hexythiazox in or on Hop, dried cone 
based on the Agency's determination that aggregate exposure to 
hexythiazox is safe for the U.S. general population and all population 
subgroups, including infants and children. That document contains a 
summary of the toxicological profile and points of departure (PODs), 
assumptions for exposure assessment, and the EPA's determination 
regarding the children's safety factor which have not changed.
    The toxicological endpoints table included in the last rule 
included inhalation exposure scenarios because EPA had concluded that 
there was a potential for residential handler inhalation exposure from 
uses on the label. EPA now assumes that products requiring personal 
protective equipment (PPE) on the label are not intended for homeowner 
use and there is no residential exposure associated with hexythiazox. 
Therefore, the aggregate exposure assessment no longer includes 
residential handler exposures, and the inhalation point of departure is 
no longer relevant for the FFDCA safety determination of hexythiazox. 
More detailed information on the risk assessment supporting the October 
30, 2017 Federal Register can be found in the document entitled, 
``Hexythiazox: Human Health Risk Assessment for Amended Use on Hops'' 
by going to http://www.regulations.gov. The referenced document is 
available in docket ID number EPA-HQ-OPP-2017-0155.
    An acute dietary risk assessment is not required since no endpoint 
attributable to a single oral exposure was identified from the 
available toxicity database. Thus, there are no acute dietary risk 
estimates of concern for the U.S. general population or any population 
subgroup, including infants and children. EPA conducted an updated 
chronic dietary exposure assessment, taking into consideration 
exposures from already established tolerances as well as the new and 
modified tolerances in this action. Chronic risks are below the 
Agency's level of concern: 97% of the chronic population adjusted dose 
(cPAD) for children 1-2 years old, the population group with the 
highest exposure. Hexythiazox is classified as ``Likely to be 
Carcinogenic to Humans.'' Based on the results of the chronic 
assessment, which is protective of potential carcinogenicity, EPA does 
not expect exposure to hexythiazox to pose a cancer risk. Using the 
exposure assumptions described for short-term exposures, EPA has 
concluded the combined short-term food, water, and residential 
exposures result in aggregate margins of exposures above the level of 
concern of 100 for all scenarios assessed and are 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 U.S. general population, or to infants and children, from 
aggregate exposure to hexythiazox residues. More detailed information 
on the subject action to amend the existing tolerances in or on 
Caneberry, Subgroup 13-07A and on Date, dried, and to establish a 
tolerance in or on Tea, dried can be found in the document entitled, 
``Hexythiazox: Human Health Risk Assessment for Amended Tolerances on 
Caneberry Subgroup 13-07A and Dates, Dried and Establishment of a 
Tolerance Without U.S. Registration for Residues in Tea'' by going to 
http://www.regulations.gov. The referenced document is available in the 
dockets established by this action, which are described under 
ADDRESSES. Locate and click on the hyperlinks for docket ID numbers 
EPA-HQ-OPP-2017-0155 and EPA-HQ-OPP-2019-0383.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate High-Performance Liquid Chromatograph/Ultraviolet 
Detection (HPLC/UV) analytical method is available for the enforcement 
of tolerances for residues of hexythiazox and its metabolites 
containing the PT-1-3 moiety in crop and livestock commodities. This 
method is listed in the U.S. EPA Index of Residue Analytical Methods 
under hexythiazox as method AMR-985-87. Hexythiazox has been tested FDA 
Multiresidue protocols C through E and the findings have been forwarded 
to the FDA. Hexythiazox metabolites were not recovered through 
protocols C through E.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 
20755-5350; telephone number: (410) 305-

[[Page 43699]]

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 Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established an MRL on tea at 15 ppm, which harmonizes 
with the U.S. tolerance on tea. Codex has also established an MRL for 
date at 2 ppm. The U.S. tolerance is not harmonized with this MRL 
because the U.S. method for measuring residues includes the 
metabolites, whereas the Codex MRL only includes measurement of the 
parent compound. The Codex has not established an MRL for residues of 
hexythiazox on raspberry, a representative commodity for caneberry 
subgroup 13-07A.

V. Conclusion

    Therefore, tolerances are amended for residues of the ovicide/
miticide hexythiazox, (4R,5R)-rel-5-(4-chlorophenyl)-N-cyclohexyl-4-
methyl-2-oxo-3-thiazolidinecarboxamide, in or on Caneberry, subgroup 
13-07A at 3 parts per million (ppm) and Date, dried at 3 ppm; and a new 
tolerance is being established in or on Tea, dried at 15 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes and 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 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 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: June 24, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.448 amend the table in paragraph (a) by revising the 
entries for ``Caneberry subgroup 13-07A'' and ``Date, dried fruit'' and 
adding in alphabetical order an entry for ``Tea, dried'' to read as 

Sec.  180.448  Hexythiazox; tolerances for residues.

    (a) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Caneberry, Subgroup 13-07A.................................            3
                                * * * * *
Date, dried................................................            3
                                * * * * *
Tea, dried \1\.............................................           15
                                * * * * *
\1\ There are no U.S. registrations for this commodity as of July 20,

* * * * *
[FR Doc. 2020-14394 Filed 7-17-20; 8:45 am]