[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Rules and Regulations]
[Pages 36071-36074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12880]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0453; FRL-9816-01-OCSPP]


Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
thiamethoxam in or on pineapples. Syngenta Crop Protection, LLC 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective June 15, 2022. Objections and 
requests for hearings must be received on or before August 15, 2022, 
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-2021-0453, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and for the OPP Docket is (202) 566-1744. Please review 
the visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting 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: 
[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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2021-0453 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 15, 2022. 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-2021-0453, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 24, 2021 (86 FR 47275) (FRL-8792-
02-

[[Page 36072]]

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 
1E8908) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested to establish a tolerance in 40 
CFR part 180.565 for residues of the insecticide, Thiamethoxam {3-[(2-
chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine{time}  and its metabolite [N-(2-chloro-thiazol-5-
ylmethyl)-N'-methyl-N'-nitro-guanidine], in or on pineapple at 0.03 
parts per million (ppm) and 0.05 ppm for pineapple, process residue. 
That document referenced a summary of the petition prepared by 
Syngenta, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received 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 the tolerances at different levels than requested. The 
reason for these changes is explained in 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. . . 
.''
    Tolerances for residues of thiamethoxam are listed in 40 CFR 
180.565 and are expressed in terms of the combined residues of the 
insecticide thiamethoxam and its metabolite CGA-322704. Metabolite CGA-
322704 is also the registered active ingredient clothianidin (tolerance 
listings in 40 CFR 180.586). Clothianidin (hereinafter referred to as 
CGA-322704) has a complete toxicological database and appears to have 
effects in mammals that are different from those of thiamethoxam. A 
separate risk assessment that addresses risks from CGA-322704 residues 
resulting from the direct application of CGA-322704 (clothianidin), as 
well as risks from residues of CGA-322704 coming from thiamethoxam uses 
has been conducted, and there are no risk estimates of concern as a 
result of the proposed tolerance for thiamethoxam residues in imported 
pineapple. This document entitled, ``Clothianidin. Human Health Risk 
Assessment to Address Exposure Associated with a New Tolerance for 
Thiamethoxam'' can be found at https://www.regulations.gov in docket ID 
number EPA-HQ-OPP-2021-0453.
    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 thiamethoxam including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with thiamethoxam 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 of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking, 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 
thiamethoxam, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to thiamethoxam and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from that rulemaking as described further 
in this rulemaking, as they remain unchanged.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of thiamethoxam, see 
Unit III.A. of the thiamethoxam tolerance rulemaking published in the 
Federal Register of February 15, 2017 (82 FR 10712) (FRL-9957-00).

B. Toxicological Points of Departure/Levels of Concern

    For a summary of the Toxicological Points of Departure/Levels of 
Concern for thiamethoxam used for human risk assessment, see Unit 
III.B. of the February 15, 2017, thiamethoxam tolerance rulemaking.

C. Exposure Assessment

    Much of the exposure assessment remains the same although updates 
have occurred to accommodate exposures from the petitioned-for 
tolerances. These updates are discussed in this section; for a 
description of the rest of the EPA approach to and assumptions for the 
exposure assessment, please reference Unit III.C. of the February 15, 
2017, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new use of thiamethoxam on imported 
pineapple. The acute assessment is based on tolerance-level residues 
and assumes 100 percent crop treated (PCT); the acute assessment is 
unrefined. The chronic assessment is based on average residues from 
crop field trials (except for tolerance-level residues in pineapple 
commodities) and assumes 100 PCT; the chronic assessment is partially 
refined. The assessments were conducted using the Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID) Version 4.02. EPA with 2005-2010 food consumption 
information from the United States Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA).
    Anticipated residue and PCT 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 exposure. EPA has revised the thiamethoxam drinking 
water assessment since the February 15,

[[Page 36073]]

2017, final rule. Based on the Pesticide in Water Calculator's (PWC) 
version 1.52, the estimated drinking water concentrations (EDWCs) of 
thiamethoxam in groundwater are 65 parts per billion (ppb) for acute 
exposures and 58 ppm for chronic exposures. Groundwater EDWCs were used 
in the dietary assessment for all sources of drinking water.
    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.'' In 2016, EPA's 
Office of Pesticide Programs released a guidance document entitled 
``Pesticide Cumulative Risk Assessment: Framework for Screening 
Analysis.'' The Agency has utilized this framework for thiamethoxam and 
determined that thiamethoxam along with clothianidin, acetamiprid, 
dinotefuran, imidacloprid, nithiazine and thiacloprid form a candidate 
common mechanism group (CMG). This group of pesticides, referred to as 
neonicotinoids, is considered a candidate CMG because they share 
characteristics to support a testable hypothesis for a common mechanism 
of action for neonicotinoids.
    Following this determination, the Agency conducted a screening-
level cumulative risk assessment consistent with the 2016 guidance 
document. The current screening assessment indicates that cumulative 
risk estimates for neonicotinoids are below the Agency's levels of 
concern. A detailed description of the cumulative screening assessment 
can be found in the Neonicotinoid Cumulative Screening Risk Assessment 
Memo (M. Perron et al., DP460743, 3/01/2021). No further cumulative 
evaluation is necessary for thiamethoxam.

D. 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. 
See Unit III.D. of the February 15, 2017, rulemaking for a discussion 
of the Agency's rationale for that determination.

E. 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 pop- ulation adjusted 
dose (cPAD). Short-, intermediate-, and chronic risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate points of departure 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.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 12% of the aPAD for children 1 to 2 years old, 
the population subgroup with the highest exposure. Chronic dietary 
risks are below the Agency's level of concern of 100% of the cPAD; they 
are 73% of the cPAD for children 1 to 2 years old, the population 
subgroup with the highest exposure.
    EPA has concluded the combined short-term food, water, and 
residential exposures result in aggregate MOEs of 130 for adults, 160 
for children older than 6 years old, and 340 for children less than 6 
years old. Because EPA's level of concern for thiamethoxam is an MOE of 
100 or below, short-term aggregate risks are not of concern. Because 
there is no intermediate-term expected residential exposure, the 
intermediate-term risk has not been assessed. Dietary exposure is the 
only relevant route of exposure for chronic durations; therefore, the 
chronic dietary risk is the same as the overall aggregate risk for 
thiamethoxam and is not of concern. Thiamethoxam is classified as ``Not 
likely to be carcinogenic to humans''; therefore, EPA does not expect 
thiamethoxam exposures 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 thiamethoxam residues. More detailed information 
on this action can be found in the document entitled, ``Thiamethoxam. 
Human Health Risk Assessment for Use on Imported Pineapple'' in the 
docket ID number, EPA-HQ-OPP-2021-0453.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the February 15, 2017, 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 has established an MRL for thiamethoxam in pineapple at 0.01 
mg/kg which is different than the U.S. tolerance. At this time, the 
Codex and EPA residue definitions are different (Codex's MRL is for the 
parent compound, thiamethoxam only, while EPA's is thiamethoxam plus 
metabolite CGA-322704); therefore, it is not possible to harmonize with 
the Codex MRL.

C. Revisions to Petitioned-For Tolerances

    The tolerance on pineapple is being set at 0.04 ppm and pineapple, 
process residue at 0.06 ppm instead of the proposed levels of 0.03 and 
0.05, respectively. The petitioner used only thiamethoxam residues as 
inputs for the Organization for Economic Cooperation and Development 
(OECD) tolerance calculation procedure. Using both thiamethoxam and its 
metabolite CGA-322704 for the input data set results in recommended 
tolerances of 0.04 ppm for pineapple and 0.06 ppm for pineapple, 
process residue.

V. Conclusion

    Therefore, a tolerance is established for residues of thiamethoxam, 
including its metabolites and degradates, in or on pineapple at 0.04 
ppm and in or on pineapple, process residue at 0.06 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 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

[[Page 36074]]

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: June 9, 2022.
Marietta Echeverria,
Acting 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.  180.565, amend paragraph (a) by designating the table as 
``Table 1 to Paragraph (a)'' and adding in alphabetical order the 
entries ``Pineapple \1\'' and ``Pineapple, process residue \1\'' to 
read as follows:


Sec.  180.565   Thiamethoxam; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pineapple \1\...............................................        0.04
 
                                * * * * *
Pineapple, process residue \1\..............................        0.06
 
                                * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities as of June 15,
  2022.

* * * * *
[FR Doc. 2022-12880 Filed 6-14-22; 8:45 am]
BILLING CODE 6560-50-P


