Rule2023-12720
Sulfoxaflor; Pesticide Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 20, 2023
Effective
June 20, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of sulfoxaflor in or on coffee, green bean. Corteva Agriscience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 117 (Tuesday, June 20, 2023)</title>
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[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Rules and Regulations]
[Pages 39780-39783]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12720]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0853; FRL-10967-01-OCSPP]
Sulfoxaflor; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
sulfoxaflor in or on coffee, green bean. Corteva Agriscience requested
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 20, 2023. Objections and
requests for hearings must be received on or before August 21, 2023,
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-2021-0853, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#3b697f7d6975544f52585e487b5e4b5a155c544d"><span class="__cf_email__" data-cfemail="05574143574b6a716c666076456075642b626a73">[email protected]</span></a>.
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
[[Page 39781]]
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0853 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
August 21, 2023. 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-2021-0853, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of March 24, 2023 (88 FR 17778) (FRL-10579-
02-OCSPP), 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
1E8945) by Corteva Agriscience, 9330 Zionsville Rd., Indianapolis, IN
46268. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the insecticide sulfoxaflor in
or on the raw agricultural commodity coffee, green bean at 0.3 parts
per million (ppm) and in or on coffee, instant at 0.5 ppm. That
document referenced a summary of the petition, which is available in
the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments
submitted in response to the notice of filing. This notice supersedes
the previous notice of August 30, 2022 (87 FR 52868) (FRL-9410-04-
OCSPP). One comment was received but was unrelated to pesticides.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is not establishing the tolerance for coffee, instant as proposed
because it is covered by the tolerance being established on coffee,
green bean. For details, see Unit IV.C.
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 therein, 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 sulfoxaflor including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with sulfoxaflor follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for sulfoxaflor
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to sulfoxaflor and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of sulfoxaflor, see Unit III.A. of the sulfoxaflor tolerance
rulemaking published in the Federal Register of May 17, 2013 (78 FR
29041) (FRL-9371-4).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
sulfoxaflor used for human health risk assessment, see Unit III.B. of
the sulfoxaflor tolerance rulemaking published in the Federal Register
of July 24, 2019 (84 FR 35546) (FRL-9995-63).
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional
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exposure from the requested tolerance for residues of sulfoxaflor in or
on coffee, green bean and were conducted with Dietary Exposure
Evaluation Model software using the Food Commodity Intake Database
(DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption
data from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). Both the acute and the chronic dietary
assessments relied primarily on residue data from supervised crop field
trials. For the acute assessment, the Agency used maximum field trial
residue values. For the chronic assessment, EPA used mean field trial
residue values. Several residue estimates were based on tolerance
levels. The acute and chronic assessments used empirical processing
factors, where available, and EPA's default processing factors in all
other cases. Empirical processing factors were translated to similar
commodities per standard Agency practice. Tolerance-level residue
estimates were used for livestock commodities and the Agency assumed
100 percent crop treated (PCT) for the acute and chronic assessments.
Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
Drinking water and non-occupational exposures. Because the
requested tolerance for residues of sulfoxaflor in or on coffee, green
bean does not include registrations for use on coffee in the U.S., the
estimated drinking water concentrations have not changed. For a
detailed summary of the drinking water analysis for sulfoxaflor used
for the human health risk assessment, see Unit III.C.2. of the July 24,
2019, rulemaking.
No residential uses and no commercial/professional uses at
residential sites are registered or proposed for sulfoxaflor;
therefore, no residential risk assessments are needed. Sulfoxaflor is
not proposed or registered for any specific use patterns that would
result in residential exposure.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to sulfoxaflor and any other substances and
sulfoxaflor does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that sulfoxaflor has a common mechanism of toxicity with
other substances.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the July 24, 2019, rulemaking for a discussion of the
Agency's rationale for that determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary (food and drinking water) exposure estimates to the acute
population-adjusted dose (aPAD) and chronic population-adjusted dose
(cPAD). Short- and intermediate-term risks are evaluated by comparing
the estimated total food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 27% of the aPAD for females 13 to 49 years old
and 25% of the aPAD for children 1 to 2 years old, the groups with the
highest exposure. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD; they are 38% of the cPAD for children 1 to
2 years old, the group with the highest exposure.
Sulfoxaflor is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Therefore, the aggregate risk estimates are equivalent to the dietary
risk estimates and are not of concern.
Sulfoxaflor is classified as ``Suggestive Evidence of Carcinogenic
Potential.'' Quantification of risk using a non-linear approach (i.e.,
reference dose (RfD)) adequately accounts for all chronic toxicity,
including carcinogenicity, that could result from exposure to
sulfoxaflor. As the chronic dietary endpoint and dose are protective of
potential cancer effects, sulfoxaflor is not expected to pose an
aggregate cancer risk.
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 sulfoxaflor residues. More detailed information
on this action can be found in the document titled ``Sulfoxaflor. Human
Health Risk Assessment for the Proposed Tolerance Without a U.S.
Registration on Coffee'' in docket ID EPA-HQ-OPP-2021-0853.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 24, 2019, rulemaking.
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).
Codex is in the process of establishing an MRL for sulfoxaflor in/
on coffee at a level of 0.3 mg/kg. The proposed U.S. tolerance for
sulfoxaflor in/on coffee green bean will be harmonized with Codex's
MRL.
C. Revisions to Petitioned-For Tolerance
EPA is not establishing the tolerance for coffee, instant as
requested because instant coffee is covered by the tolerance being
established on coffee, green bean. EPA considers instant coffee to be a
blended commodity; therefore, the average raw agricultural commodity
(RAC) value is used to calculate residues in processed commodities.
When the mean concentration for the RAC (0.047 ppm) is multiplied by
the average processing factor for instant coffee (2.4x), the
anticipated residue is 0.11 ppm, which is covered by the tolerance for
coffee, green bean.
As a housekeeping measure, EPA is removing tolerances that have
expired. Specifically, EPA is removing the general tolerances for
residues of sulfoxaflor in or on arugula at 6 ppm; cress, garden at 6
ppm; and cress,
[[Page 39783]]
upland at 6 ppm from paragraph (a) of 40 CFR 180.668 because they
expired on January 24, 2020. Additionally, EPA is removing the time-
limited tolerances for residues of sulfoxaflor in or on sorghum, forage
at 0.4 ppm; sorghum, grain at 0.3 ppm; and sorghum, stover at 0.9 ppm
from paragraph (b) of 40 CFR 180.668 because they expired on December
31, 2020.
V. Conclusion
Therefore, a tolerance is established for residues of sulfoxaflor
in or on coffee, green bean at 0.3 ppm. In addition, EPA is removing
the expired general tolerances for residues of sulfoxaflor in or on
arugula at 6 ppm; cress, garden at 6 ppm; and cress, upland at 6 ppm
and the expired time-limited tolerances for residues of sulfoxaflor in
or on sorghum, forage at 0.4 ppm; sorghum, grain at 0.3 ppm; and
sorghum, stover at 0.9 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 to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). 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 9, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. 180.668:
0
a. Amend the table in paragraph (a) by:
0
i. Adding a heading for the table.
0
ii. Removing the entry for ``Arugula \1\''.
0
iii. Adding alphabetically the commodity ``Coffee, green bean''.
0
iv. Removing the entries for ``Cress, garden \1\'' and ``Cress, upland
\1\''.
0
v. Revising footnote 1.
0
b. Remove and reserve paragraph (b).
The additions read as follows:
Sec. 180.668 Sulfoxaflor; tolerances for residues.
* * * * *
Table 1 to Paragraph (a)
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Commodity Parts per million
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* * * * *
Coffee, green bean \1\.................... 0.3
* * * * *
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\1\ There are no U.S. registrations as of June 20, 2023.
(b) [Reserved]
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[FR Doc. 2023-12720 Filed 6-16-23; 8:45 am]
BILLING CODE 6560-50-P
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