[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]
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ENVIRONMENTAL PROTECTION AGENCY
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.
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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.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director,
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].
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 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
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 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
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 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)-
rel-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-3-
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
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 hexythiazox including exposure
resulting from the tolerances established by this action. A summary of
EPA's assessment of exposures and risks associated with hexythiazox
follows.
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:
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. 180.448 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
follows:
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,
2020.
* * * * *
[FR Doc. 2020-14394 Filed 7-17-20; 8:45 am]
BILLING CODE 6560-50-P