
[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Rules and Regulations]
[Pages 60594-60597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19012]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0384; FRL-11035-01-OCSPP]


Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spinetoram in or on Spice group 26, and Stalk and stem vegetable 
subgroup 22A. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective September 5, 2023. Objections and 
requests for hearings must be received on or before November 6, 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-2022-0384, 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 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-2022-0384 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 
November 6, 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

[[Page 60595]]

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-2022-0384, 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 January 3, 2023 (88 FR 38) (FRL-9410-08-
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 
2E8994) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to 
amend 40 CFR part 180 by establishing tolerances for residues of 
spinetoram in or on the raw agricultural commodities Stalk and stem 
vegetable subgroup 22A at 0.4 parts per million (ppm), and Spice group 
26 at 1.7 ppm.
    The petition also requested to remove established tolerances for 
residues of spinetoram in or on the following: Asparagus, and Spice 
subgroup 19B, except black pepper.
    That document referenced a summary of the petition, which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice.

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 spinetoram including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with spinetoram 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 rulemaking 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 several tolerance rulemakings for 
spinetoram, in which EPA concluded, based on the available information, 
that there is a reasonable certainty that no harm would result from 
aggregate exposure to spinetoram and established tolerances for 
residues of that chemical. EPA is incorporating previously published 
sections of those rulemakings that remain unchanged, as described 
further in this rulemaking. Specific information on the risk assessment 
conducted in support of this action, including on the studies received 
and the nature of the adverse effects caused by spinetoram, can be 
found in the document titled ``Spinosad and Spinetoram: Human Health 
Risk Assessment in Support of Proposed Uses on Stalk and Stem 
Vegetables (22A) and Greenhouse-Grown Cucumbers, Lettuce, Pepper, and 
Tomato; and Crop Group Conversion for Spice Group 26'' (hereinafter 
``Spinosad and Spinetoram Human Health Risk Assessment'') which is 
available in the docket for this action at https://www.regulations.gov.
    Toxicological profile. For a discussion of the Toxicological 
Profile of spinetoram, see Unit III.A. of the rulemaking published in 
the Federal Register of August 8, 2018 (83 FR 38976) (FRL-9978-83).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern used for the 
safety assessment of spinetoram, see Unit III.B. of the August 8, 2018, 
rulemaking.
    Exposure assessment. Much of the exposure assessment remains 
unchanged from the August 8, 2018, rulemaking, although the new 
exposure assessment incorporates the additional dietary exposure from 
the petitioned-for tolerances. Other changes are described below.
    A chronic dietary exposure assessment was conducted using DEEM-FCID 
Version 4.02. This software uses 2005-2010 food consumption data from 
the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
Acute and cancer analyses were not conducted as toxicological effects 
attributable to a single dose were not identified, and spinetoram is 
classified as not likely to be carcinogenic. The chronic dietary 
analysis assumed 100 percent crop treated (PCT), average field-trial 
residues or tolerance-level residues for crop commodities, average 
residues from the livestock feeding studies, experimental processing 
factors when available, and modeled drinking water estimates.
    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. The estimated 
drinking water concentrations (EDWCs) of spinetoram have been updated 
since the

[[Page 60596]]

last assessment. Based on the Tier I Rice Model and Pesticide Root Zone 
Model Ground Water (PRZM GW), the EDWCs of spinetoram for chronic 
exposures are estimated to be 38 parts per billion (ppb) for surface 
water and below the levels of detection for ground water.
    Modeled estimates of drinking water concentration were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration value of 38 ppb was used to assess 
the contribution to drinking water.
    There have been no changes to residential exposures since the 
August 8, 2018, rulemaking. For calculation of aggregate short-term 
exposure, residential exposure to adults (residential handler exposure 
from applying spinetoram to turf/ornamentals/home garden), children 3 
to less than 6 years old (combined post-application inhalation and 
ingestion of water exposure during recreational swimming), and children 
1 to less than 2 years old (post-application exposure resulting from 
the application of spinetoram to turf/ornamentals/home gardens) yield 
the highest residential short-term exposure and were therefore used in 
calculation of aggregate 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 spinetoram and any other substances and 
spinetoram does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this action, therefore, EPA has 
not assumed that spinetoram has a common mechanism of toxicity with 
other substances.
    Safety factor for infants and children. EPA continues to conclude 
that there is reliable data showing that the safety of infants and 
children would be adequately protected if the Food Quality Protection 
Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for 
that decision are articulated in Unit III.D. of the August 8, 2018, 
rulemaking.
    Aggregate risks and determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
dietary exposure estimates to the acute population-adjusted dose (aPAD) 
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and 
chronic-term aggregate 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.
    An acute assessment was not conducted because toxicological effects 
attributable to a single dose were not identified. Chronic dietary 
(food and drinking water) 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, which is the population subgroup with the highest exposure 
estimate.
    The short-term aggregate risks combine chronic dietary (food and 
drinking water) and residential exposures. The short-term aggregate 
risk for adults is an aggregate MOE of 740; for children aged 3 to less 
than 6, the aggregate MOE is 330; and for children 1 to less than 2 
years old, the aggregate MOE is 200. MOEs below 100 are of concern; 
these MOEs are above 100 and therefore are not of concern. Short-term 
aggregate risk calculations are protective of the intermediate-term 
duration of exposure.
    Because spinetoram is classified as ``not likely to be carcinogenic 
to humans'', EPA has concluded that aggregate exposure to spinetoram is 
not likely to pose a 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 spinetoram residues. More detailed information 
about the Agency's analysis can be found at https://www.regulations.gov 
in the Spinosad and Spinetoram Human Health Risk Assessment in docket 
ID EPA-HQ-OPP-2022-0384.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the August 8, 2018, 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).
    There are currently no established Codex MRLs for residues of 
spinetoram in or on Stalk and stem vegetable subgroup 22A or Spice 
Group 26.

V. Conclusion

    Therefore, tolerances are established for residues of spinetoram in 
or on Spice group 26 at 1.7 ppm, and the Stalk and stem vegetable 
subgroup 22A at 0.4 ppm.
    Additionally, the established tolerances on Asparagus, and Spice, 
subgroup 19B, except black pepper, are removed as unnecessary.

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 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

[[Page 60597]]

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: August 24, 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.  180.635, amend the table 1 to paragraph (a) by:
0
a. Removing the commodity ``Asparagus'';
0
b. Adding in alphabetical order the commodity ``Spice group 26''
0
c. Removing the commodity ``Spice, subgroup 19B, except black pepper''; 
and
0
d. Adding in alphabetical order the commodity ``Stalk and stem 
vegetable subgroup 22A''.
    The additions read as follows:


Sec.  180.635  Spinetoram; tolerances for residues.

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                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Spice group 26..............................................         1.7
Stalk and stem vegetable subgroup 22A.......................         0.4
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2023-19012 Filed 9-1-23; 8:45 am]
BILLING CODE 6560-50-P


