[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Rules and Regulations]
[Pages 56653-56656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22104]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2020-0511; FRL-8667-01-OCSPP]
Clothianidin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of the
insecticide clothianidin in or on food and feed commodities (other than
those covered by a higher tolerance) in food/feed handling
establishments. McLaughlin Gormley King Company D/B/A MGK requested
tolerances for these commodities under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective October 12, 2021. Objections and
requests for hearings must be received on or before December 13, 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-2020-0511, 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. 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.
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, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; 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(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-2020-0511 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
December 13, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b), although at this
time, EPA strongly encourages those interested in submitting objections
or a hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal deliver,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
Although EPA's regulations require submission via U.S. Mail or hand
deliver, EPA intends to treat submissions filed via electronic means as
properly filed submissions during this time that the Agency continues
to maximize telework due to the pandemic; therefore, EPA believes the
preference for submission via electronic means will not be prejudicial.
If it is impossible for a person to submit documents electronically or
receive service electronically, e.g., the person does not have any
access to a computer, the person shall so advise OALJ by contacting the
Hearing Clerk at (202) 564-6281. If a person is without access to a
computer and must file documents by U.S. Mail, the person shall notify
the Hearing Clerk every time it files a document in such a manner. The
address for mailing documents is U.S. Environmental Protection Agency,
Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
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-
[[Page 56654]]
2020-0511, 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.
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 October 27, 2020 (85 FR 68030) (FRL-
10015-86), 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
0F8869) by McLaughlin Gormley King Company D/B/A MGK, 7325 Aspen Lane
N, Minneapolis, MN 55428. The petition requested that 40 CFR
180.586(a)(1) be amended by establishing tolerances for residues of the
insecticide clothianidin, (E)-N-[(2-Chloro-5-thiazolyl)methyl]-N'-
methyl-N''-nitroguanidine, in or on all food items in food handling
establishments where food and food products are held, processed,
prepared, and/or served at 0.01 parts per million (ppm). That document
referenced a summary of the petition prepared by McLaughlin Gormley
King Company D/B/A MGK, the registrant, which is available in the
docket, http://www.regulations.gov. There was one, non-substantive
comment received on November 8, 2020, in response to the notice of
filing.
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 establishing tolerances that vary from what the petitioners sought.
The reasons for these changes are explained in detail 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 the 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 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 clothianidin in or on food and feed commodities
(other than those covered by a higher tolerance).
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 of 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 republishing the same sections is
unnecessary; 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 recently published a tolerance rulemaking for clothianidin,
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to clothianidin and established tolerances for residues of
that chemical. EPA is incorporating previously published sections from
those rulemakings as described further in this rulemaking, as they
remain unchanged.
Toxicological Profile. For a discussion of the Toxicological
Profile of clothianidin, see Unit III.A. of the November 25, 2019
rulemaking (84 FR 64772) (FRL-10000-64).
Toxicological Points of Departure/Levels of Concern. A summary of
the toxicological effects of clothianidin, including the specific
information on the studies received, the nature of the adverse effects
caused by clothianidin, the no observed adverse effects level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov in the document
entitled ``Clothianidin: Draft Human Health Risk Assessment in Support
of Registration Review,'' dated September 7, 2017. This document can be
found in docket ID number EPA-HQ-OPP-2011-0865.
Exposure Assessment. EPA has updated the exposure assessments of
clothianidin to include the petitioned-for tolerances in addition to
exposures associated with existing tolerances for clothianidin in 40
CFR 180.586. The acute and chronic dietary exposure assessments for
clothianidin were conducted using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database DEEM-
FCIDTM, Version 3.16, which incorporates consumption data
from USDA's National Health and Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA). This dietary survey was conducted from
2003 to 2008.
The acute dietary exposure assessment is based on tolerance-level
residues for all commodities since EPA typically does not include FHE
uses in acute dietary assessments. In addition, the acute dietary
exposure assessment assumes 100% crop treated (PCT) and incorporates
the modeled EDWCs. Therefore, the resulting exposure and risk estimates
are conservative.
The partially refined chronic dietary exposure assessment is based
on average field trial residues and assumes 100 PCT. Average residues
from representative commodities were extrapolated to similar
commodities. Because thiamethoxam, which also breaks down into
clothianidin residues, is also registered for FHE use, EPA accounts for
clothianidin residues from both thiamethoxam and clothianidin FHE uses
in the chronic assessment. For these analyses, a residue input value
for FHE use was entered for all other commodities in DEEM-
FCIDTM not registered for direct use. Default processing
factors were used, except where empirical factors derived from
processing studies were available.
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
[[Page 56655]]
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.
EPA also used the same estimates for potential drinking water
exposures as reflected in the November 25, 2019, rulemaking. Since the
proposed use is for indoor applications, a new drinking water
assessment was not needed.
Clothianidin is registered for uses that may result in residential
(non-occupational) exposures. EPA has assessed the potential for short-
term post-application exposure; other exposures are not expected. No
residential risks of concern were identified. For aggregate risk
assessment, EPA used the risk estimates from the combined dermal and
inhalation exposures for adults from indoor aerosol can usage and from
the combined dermal, inhalation, and incidental oral exposures for
children 1 to less than 2 years old from treated indoor surfaces.
Safety Factor for Infants and Children. Section 408(b)(2)(C) of the
FFDCA provides that EPA shall apply an additional tenfold (10x) margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure unless EPA determines based on
reliable data that a different margin of safety will be safe for
infants and children. This additional margin of safety is commonly
referred to as the FQPA Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10 times, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
EPA determined reliable data show the safety of infants and
children would be adequately protected if the FQPA SF were reduced to
1x because: (1) The toxicology data base is complete and includes
developmental neurotoxicity (DNT), adult immunotoxicity and
developmental immunotoxicity studies; (2) EPA characterized the degree
of concern for the quantitative susceptibility observed in the
clothianidin 2-generation reproduction and DNT studies as low based on
the clear NOAELs for the offspring effects and the selection of
regulatory doses that are protective of those effects; (3) the rat is
the most sensitive species tested, and the NOAEL and LOAEL selected
from the two-generation reproduction study in rats are protective of
effects observed in the toxicology database, including the DNT and
developmental immunotoxicity studies; (4) there are no residual
uncertainties for pre- and/or post-natal toxicity; (5) EPA is
regulating the use of clothianidin based upon the most sensitive
offspring effects observed in the reproduction toxicity study, and
therefore the risk assessment is protective of these and other effects
that occurred at higher doses; (6) the exposure databases (e.g.,
dietary food, drinking water, and residential) are complete; and (7)
the risk assessment for each potential exposure scenario does not
underestimate potential exposure and risk for infants or children.
Aggregate Risks and Determination of Safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate points of departure (PODs)
to ensure that an adequate margin of exposure (MOE) exists. For linear
cancer risks, EPA calculates the lifetime probability of acquiring
cancer given the estimated aggregate exposure.
The acute dietary risk estimates for clothianidin are 9.5% of the
aPAD for the U.S. general population, and 29% of the aPAD for children
1 to 2 years old (the most highly exposed population subgroup). The
chronic dietary risk estimates are 3.9% of the cPAD for the U.S.
general population, and 9.4% of the cPAD for infants less than 1-year
old (the most highly exposed population subgroup). Because both are
below the 100% of the relevant PAD, these risk estimates are not of
concern.
The short-term aggregate risk assessments resulted in MOEs of 150
to 490. For clothianidin, the LOC for short-term risk is an MOE of 100.
As the resulting aggregate MOEs exceed the LOC of 100, short-term
aggregate risk estimates are not of concern. Intermediate-term and
long-term residential exposures are not expected.
Clothianidin is classified as ``Not Likely to be Carcinogenic to
Humans;'' therefore, cancer risk is not a concern and cancer risks are
not quantified.
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 clothianidin residues. More detailed information on the
subject action to establish a tolerance in or on food and feed
commodities (other than those covered by a higher tolerance) can be
found at http://www.regulations.gov in the document entitled
``Clothianidin. Petition for the Establishment of Permanent Tolerances
and Registration for Use in Food Handling Establishment,'' dated July
15, 2021. This document can be found in docket ID number EPA-HQ-OPP-
2020-0511.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate Liquid Chromatograph/Mass Spectrometer/Mass Spectrometer
(LC/MS/MS) methods are available for enforcing tolerances of
clothianidin residues in/on crop (Morse Method #Meth-164--modified, RM-
39C-1, or Bayer Method 00552) and livestock (Bayer Method 00624)
matrices.
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Road, 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). Codex 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.
Although EPA may establish a tolerance that is different from a Codex
MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for
departing from the Codex level.
Codex has not established MRLs for food commodities based on the
petitioned-for use in food handling establishments.
C. Revisions to Petitioned-For Tolerances
The petition described the use of clothianidin in or on ``all food
items in food handling establishments where food and food products are
held, processed, prepared and/or served.''
[[Page 56656]]
EPA has revised this language for the requested tolerance to read
``Food and feed commodities (other than those covered by a higher
tolerance) in food/feed handling establishments.''
V. Conclusion
Tolerances are established for residues of the insecticide
clothianidin in or on food and feed commodities (other than those
covered by a higher tolerance) at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes 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). 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: October 5, 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. 180.586, amend paragraph (a)(1) by
0
a. Designating the table as table 1; and
0
b. In newly redesignated table 1, adding in alphabetical order an entry
for ``Food and feed commodities (other than those covered by a higher
tolerance) in food/feed handling establishments''.
The additions read as follows:
Sec. 180.586 Clothianidin; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
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Parts per
Commodity million
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* * * * * * *
Food and feed commodities (other than those covered by a 0.01
higher tolerance) in food/feed handling establishments....
* * * * * * *
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* * * * *
[FR Doc. 2021-22104 Filed 10-8-21; 8:45 am]
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