[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 [www.gpo.gov]
[FR Doc No: 2023-12720]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
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 the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

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: 
[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

[[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:
     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-2021-0853 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:
     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 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, https://www.regulations.gov. 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

[[Page 39782]]

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)
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
 
                                * * * * *
Coffee, green bean \1\....................  0.3
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of June 20, 2023.

    (b) [Reserved]
* * * * *

[FR Doc. 2023-12720 Filed 6-16-23; 8:45 am]
BILLING CODE 6560-50-P


