Document ID: EPA-HQ-OPP-2020-0511-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Clothianidin
Posted Date: 2021-10-12T04:00Z

[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)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Food and feed commodities (other than those covered by a            0.01
 higher tolerance) in food/feed handling establishments....
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-22104 Filed 10-8-21; 8:45 am]
BILLING CODE 6560-50-P