[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Rules and Regulations]
[Pages 40118-40122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12126]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0128; FRL-10009-93]
Oxathiapiprolin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
oxathiapiprolin in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) and the registrant, Syngenta Crop Protection requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 6, 2020. Objections and
requests for hearings must be received on or before September 4, 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 docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0128, 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
[[Page 40119]]
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 Goodis, 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-2019-0128 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 4, 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 number EPA-HQ-OPP-2019-0128, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. 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
9E8755) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.685 be amended by establishing tolerances for
residues of the fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-
difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-
2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on the
following commodities: Berry, low growing, subgroup 13-07G, except
cranberry at 0.4 parts per million (ppm); Hop, dried cones at 5 ppm;
Tropical and subtropical, medium to large fruit, smooth, inedible peel,
subgroup 24B at 0.1 ppm; individual crops of proposed crop subgroup 6-
18B: Edible podded pea legume vegetable subgroup including: Chickpea,
edible podded at 1 ppm; Dwarf pea, edible podded at 1 ppm; Edible
podded pea at 1 ppm; Grass-pea, edible podded at 1 ppm; Green pea,
edible podded at 1 ppm; Lentil, edible podded at 1 ppm; Pigeon pea,
edible podded at 1 ppm; Snap pea, edible podded at 1 ppm; Snow pea,
edible podded at 1 ppm; and Sugar snap pea, edible podded at 1 ppm; and
individual crops of proposed crop subgroup 6-18D: Succulent shelled pea
subgroup including: Chickpea, succulent shelled at 0.05 ppm; English
pea, succulent shelled at 0.05 ppm; Garden pea, succulent shelled at
0.05 ppm; Green pea, succulent shelled at 0.05 ppm; Lentil, succulent
shelled at 0.05 ppm; and Pigeon pea, succulent shelled at 0.05 ppm. In
addition, IR-4 requested removal of the following existing tolerances
upon establishment of the above tolerances for residues of the
fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-
3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on Pea, edible-
podded at 1.0 ppm and Pea, succulent shelled at 0.05 ppm.
In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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
9F8736) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419, that requested to establish tolerances in 40 CFR part 180.685
for residues of the fungicide oxathiapiprolin (1-[4-[4-[5-(2,6-
difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-
2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone), in or on
bushberry crop subgroup 13-07B, except lowbush blueberry, at 0.5 ppm;
tree nuts, crop group 14-12 at 0.01 ppm; and almond hulls at 0.05 ppm.
These documents referenced a summary of the petition prepared by
Syngenta Crop Protection, LLC, the registrant, which is available in
the docket, http://www.regulations.gov. One comment was received on the
notice of filings. EPA's response to this comment is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA is
correcting many of the commodity definitions. The reasons for these
changes are explained in Unit IV.D.
[[Page 40120]]
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 oxathiapiprolin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with oxathiapiprolin
follows.
As indicated in the Federal Register for previous tolerances
established for residues of oxathiapiprolin (see 81 FR 87463, FRL-9954-
69, December 6, 2016), the toxicity database for oxathiapiprolin
supports a decision to conduct a qualitative risk assessment, due to
the lack of treatment-related effects and limited toxicity. While
dietary exposure to oxathiapiprolin may occur through food and drinking
water, no risks of concern are anticipated due to the lack of toxicity
at anticipated human exposure levels. While residential post-
application exposures may occur through the registered uses on turf and
ornamentals, no risks of concern are anticipated due to the lack of
toxicity at anticipated human exposure levels. While dietary and
residential exposures may occur through the registered and proposed
uses for oxathiapiprolin, no aggregate risks of concern are anticipated
due to the lack of toxicity at anticipated human exposure levels.
Therefore, based on the lack of toxicity at anticipated human
exposure levels, 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 oxathiapiprolin residues. More detailed
information on the subject action to establish tolerances in or on the
range of commodities can be found in the document entitled,
``Oxathiapiprolin. Human Health Risk Assessment to Support the
Registration for Use on Bushberry Crop Subgroup 13-07B (Except Lowbush
Blueberry), Hops, Low Growing Berry Crop Subgroup 13-07G (Except
Cranberry), Tree Nut Crop Group 14-12, and Tropical and Subtropical
Medium to Large Fruit with Smooth Inedible Peel Crop Subgroup 24B, as
well as Tolerance Translations'' dated May 15, 2020 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-2019-0128.
IV. Other Considerations
A. Analytical Enforcement Methodology
Analytical method DuPont-30422, Supplement 1 is a high performance
liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method
available for the quantitation of oxathiapiprolin residues in plant
matrices. Analytical method DuPont-31138 is an HPLC-MS/MS method
available for the analytical enforcement of oxathiapiprolin residues in
livestock commodities.
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 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 MRLs for oxathiapiprolin in/on peas (pods
and succulent-immature seeds) at 1 ppm and in/on peas, shelled
(succulent seeds) at 0.05 ppm. The U.S. tolerances for the
corresponding commodities are harmonized with these Codex MRLs. The
Codex has not established MRLs for oxathiapiprolin on any of the other
requested crops or crop groups.
C. Response to Comments
One relevant comment was received from a private citizen who
opposed approval of this active ingredient due to combination with
other chemicals and not testing toxic pollutants. The existing legal
framework provided by section 408 of the FFDCA states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This comment appears to be directed at the underlying
statute and not EPA's implementation of it; the comments provide no
information relevant the Agency's safety determination.
D. Revisions to Petitioned-For Tolerances
The Agency corrected the commodity definitions for: Almond, hulls;
Bushberry subgroup 13-07B, except lowbush blueberry; Nut, tree, group
14-12; Pea, dwarf, edible podded; Pea, edible podded; Pea, English,
succulent shelled; Pea, garden, succulent shelled; Pea, grass, edible
podded; Pea, green, edible podded; Pea, green, succulent shelled; Pea,
pigeon, edible podded; Pea, pigeon, succulent shelled; Pea, snap,
edible podded; Pea, snow, edible podded; and Pea, sugar snap, edible
podded.
V. Conclusion
Therefore, tolerances are established for residues of
oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on Almond, hulls at
0.05 ppm; Berry, low growing, subgroup 13-07G, except cranberry at 0.4
ppm; Bushberry subgroup 13-07B, except lowbush blueberry at 0.5 ppm;
Chickpea, edible podded at 1 ppm; Chickpea, succulent shelled at 0.05
ppm; Hop, dried cones at 5 ppm; Lentil, edible podded at 1 ppm; Lentil,
succulent shelled at 0.05 ppm; Nut, tree, group 14-12 at 0.01
[[Page 40121]]
ppm; Pea, dwarf, edible podded at 1 ppm; Pea, edible podded at 1 ppm;
Pea, English, succulent shelled at 0.05 ppm; Pea, garden, succulent
shelled at 0.05 ppm; Pea, grass, edible podded at 1 ppm; Pea, green,
edible podded at 1 ppm; Pea, green, succulent shelled at 0.05 ppm; Pea,
pigeon, edible podded at 1 ppm; Pea, pigeon, succulent shelled at 0.05
ppm; Pea, snap, edible podded at 1 ppm; Pea, snow, edible podded at 1
ppm; Pea, sugar snap, edible podded at 1 ppm; Tropical and subtropical,
medium to large fruit, smooth inedible peel, subgroup 24B at 0.1 ppm.
Upon the establishment of the above tolerances, the following
tolerances will be removed: Pea, edible-podded at 1.0 ppm and Pea,
succulent shelled at 0.05 ppm.
The removal of the ``pea, edible-podded'' and ``pea, succulent
shelled'' tolerances as part of this rulemaking will not result in any
adulterated pea commodities. The individual pea tolerances being
established in this rulemaking cover all the edible-podded and
succulent-shelled versions of pea as defined in 40 CFR 180.1, which
includes ``Cajanus cajan (includes pigeon pea); Cicer spp. (includes
chickpea and garbanzo bean); Lens culinaris (lentil); Pisum spp.
(includes dwarf pea, garden pea, green pea, English pea, field pea, and
edible pod pea).'' To avoid confusion about the coverage of residues in
or on pea commodities as a result of this rulemaking, EPA is clarifying
the status of two commodities listed in section 180.1 for which an
individual tolerance is not being established in this rulemaking:
Garbanzo bean and field pea. Garbanzo bean is the same commodity as
chickpea, so residues on garbanzo bean are covered by chickpea
tolerances. Field pea is not sold as an edible-podded or succulent
shelled pea and thus is not covered by the existing tolerances for
``pea, edible-podded'' and pea, succulent shelled''; removing those
tolerances does not change the status of tolerance coverage for field
pea and an individual tolerance is not necessary.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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 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: May 26, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA amends 40
CFR chapter I as follows:
PART 180--[AMENDED]
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. 180.685, amend the table in paragraph (a) by
0
i. Adding in alphabetical order entries for ``Almond, hulls''; ``Berry,
low growing, subgroup 13-07G, except cranberry''; ``Bushberry subgroup
13-07B, except lowbush blueberry''; ``Chickpea, edible podded'';
``Chickpea, succulent shelled''; ``Hop, dried cones''; ``Lentil, edible
podded''; ``Lentil, succulent shelled''; ``Nut, tree, group 14-12'';
``Pea, dwarf, edible podded''; ``Pea, edible podded''; ``Pea, English,
succulent shelled''; ``Pea, garden, succulent shelled''; ``Pea, grass,
edible podded''; ``Pea, green, edible podded''; ``Pea, green, succulent
shelled''; ``Pea, pigeon, edible podded''; ``Pea, pigeon, succulent
shelled''; ``Pea, snap, edible podded''; ``Pea, snow, edible podded'';
``Pea, sugar snap, edible podded''; and ``Tropical and subtropical,
medium to large fruit, smooth inedible peel, subgroup 24B''; and
0
ii. Removing the entries for: ``Pea, edible-podded''; and ``Pea,
succulent shelled''.
The additions read as follows:
Sec. 180.685 Oxathiapiprolin; tolerances for residues.
(a) * * *
[[Page 40122]]
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Parts per
Commodity million
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Almond, hulls........................................... 0.05
* * * * * * *
Berry, low growing, subgroup 13-07G, except cranberry... 0.4
* * * * * * *
Bushberry subgroup 13-07B, except lowbush blueberry..... 0.5
* * * * * * *
Chickpea, edible podded................................. 1
Chickpea, succulent shelled............................. 0.05
* * * * * * *
Hop, dried cones........................................ 5
* * * * * * *
Lentil, edible podded................................... 1
Lentil, succulent shelled............................... 0.05
Nut, tree, group 14-12.................................. 0.01
* * * * * * *
Pea, dwarf, edible podded............................... 1
Pea, edible podded...................................... 1
Pea, English, succulent shelled......................... 0.05
Pea, garden, succulent shelled.......................... 0.05
Pea, grass, edible podded............................... 1
Pea, green, edible podded............................... 1
Pea, green, succulent shelled........................... 0.05
Pea, pigeon, edible podded.............................. 1
Pea, pigeon, succulent shelled.......................... 0.05
Pea, snap, edible podded................................ 1
Pea, snow, edible podded................................ 1
Pea, sugar snap, edible podded.......................... 1
* * * * * * *
Tropical and subtropical, medium to large fruit, smooth, 0.1
inedible peel, subgroup 24B............................
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-12126 Filed 7-2-20; 8:45 am]
BILLING CODE 6560-50-P