[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Rules and Regulations]
[Pages 72190-72193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27551]



40 CFR Part 180

[EPA-HQ-OPP-2020-0022; FRL-9123-01-OCSPP]

Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
spinetoram in or on multiple commodities which are identified and 
discussed later in this document. Clarke Mosquito Control Products, 
Inc., requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 21, 2021. Objections and 
requests for hearings must be received on or before February 22, 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-2020-0022, 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 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, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].


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:

[[Page 72191]]

     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-2020-0022 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 
February 22, 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-2020-0022, 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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    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 3, 2020 (85 FR 12454) (FRL-10005-
58), 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 
9F8804) by Clarke Mosquito Control Products, Inc., 675 Sidwell Court, 
St. Charles, IL 60174. The petition requested that 40 CFR 180.635 be 
amended by establishing tolerances for residues of the insecticide 
spinetoram, expressed as a combination of XDE-175-J: 1-H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-
di-O-methyl-mannopyranosyl) oxy]-13-[[(2R,5S,6R)-5-
(2R,3aR, 5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1-H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6deoxy-3-O-ethyl-2,4-di-O-methyl-
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J: 
[alpha]-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
3-yl(methyl)formamide, in or on fish at 4.0 parts per million (ppm); 
fish-shellfish, crustacean at 4.0 ppm; fish-shellfish, mollusc at 4.0 
ppm; grass, forage, fodder and hay, group 17, forage at 10.0 ppm; 
grass, forage, fodder and hay, group 17, hay at 5.0 ppm; animal feed, 
nongrass, group 18, forage at 35.0 ppm; and animal feed, nongrass, 
group 18, hay at 30.0 ppm to account for incidental residues from the 
proposed use of spinetoram as a mosquito larvicide in aquatic areas and 
standing water within agricultural sites. That document referenced a 
summary of the petition prepared by Clarke Mosquito Control Products, 
Inc., the petitioner, which is available in the docket, https://www.regulations.gov. Two non-substantive comments were received on the 
notice of filing and the notice of receipt and did not result in 
changes to EPA's decision. Based upon review of the data supporting the 
petition, EPA has removed the trailing zeros on the requested tolerance 
values and revised certain commodity terms. 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. . . 
    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 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 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.

[[Page 72192]]

    EPA has previously published 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. While these tolerances are being established for spinetoram 
use as a larvicide, the previous spinetoram tolerance rulemaking was 
based on the databases for both spinetoram and spinosad.
    Toxicological profile. Spinetoram and spinosad are considered by 
EPA to be toxicologically identical for human health risk assessment 
based on their very similar chemical structures and similarity of the 
toxicological databases for currently available studies. Therefore, the 
Agency has assessed and summarized the toxicological profile for both 
together. For a discussion of the Toxicological Profile of spinetoram 
and spinosad, see Unit III.A. of the previous spinetoram tolerance 
rulemaking published in the Federal Register of August 8, 2018 (83 FR 
38976) (FRL-9978-83).
    Toxicological points of departure/Levels of concern. Spinetoram and 
spinosad should be considered toxicologically identical in the same 
manner that metabolites are generally considered toxicologically 
identical to the parent. As a result, studies from both toxicological 
databases were considered for endpoint selection. For a summary of the 
Toxicological Points of Departure/Levels of Concern used for the safety 
assessment, see Unit III.B. of the August 8, 2018 rulemaking.
    Exposure assessment. In evaluating dietary exposure to spinetoram 
and spinosad, EPA considered exposure under the petitioned-for 
spinetoram tolerances as well as all existing spinetoram and spinosad 
tolerances. Spinosad is currently registered for use as a mosquito 
larvicide in aquatic areas and standing water within agricultural 
sites, and there are existing tolerances for incidental residues of 
spinosad in or on the same commodities identified in this action. 
Because application rates for the proposed mosquito larvicide use of 
spinetoram are lower than spinosad, incidental residues of spinetoram 
in or on these commodities will not exceed the existing spinosad 
tolerances. Moreover, because spinetoram and spinosad are used to 
control similar pests and are not likely to be used in combination with 
each other, EPA has concluded it would overstate exposure to assume 
that residues of both spinetoram and spinosad would appear on the same 
commodities. Therefore, much of the dietary exposure assessment remains 
unchanged from the August 8, 2018 rulemaking, which included the 
existing spinosad tolerances.
    The currently registered maximum application rate for spinosad was 
used to assess residential exposure, as this rate is higher than the 
proposed application rate for spinetoram. The residential assessment 
for spinosad is protective for spinetoram for the reasons described 
    For a description of the rest of the EPA approach to and 
assumptions for the exposure assessment, including with respect to 
dietary exposure, residential exposure, and cumulative effects, see 
Unit III.C. of the August 8, 2018 rulemaking.
    Safety factor for infants and children. EPA continues to conclude 
that there is reliable data showing that the safety of infants and 
children is adequately protected if the Food Quality Protection Act 
safety factor is reduced from 10X to 1X. The reasons for that 
determination are articulated in Unit III.D. of the August 8, 2018 
    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 population adjusted dose (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.
    An acute dietary exposure assessment was not conducted as 
toxicological effects attributable to a single dose were not 
identified. Chronic dietary risks are below the Agency's level of 
concern of 100% of the cPAD: Children 1 to 2 years old are the 
population subgroup with the highest exposure estimate at 72% of the 
cPAD. The short-term aggregate MOE (food, water, and residential) is 
200 for children 1 to less than 2 years old and 840 for adults. These 
MOEs do not exceed the level of concern, which are MOEs of 100 or 
below. The short-term aggregate risk assessment is protective of 
intermediate-term exposure as the short-term and intermediate-term PODs 
are identical. EPA has also concluded that spinetoram is not expected 
to pose a cancer risk to humans based on the lack of evidence of 
carcinogenicity in the database.
    Determination of safety. 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 document titled ``Spinetoram: Human 
Health Risk Assessment in Support of Proposed New Granular Sand 
Formulation for Use as a Mosquito/Larvicide and Proposed Tolerance for 
Residues of Spinetoram on Fish; Fish-shellfish, Crustacean; Fish-
Shellfish, Mollusc; Grass, Forage, Fodder and Hay, Group 17, Forage; 
Grass, Forage, Fodder and Hay, Group 17, Hay; Animal Feed, Nongrass, 
Group 18, Forage; and Animal Feed, Nongrass, Group 18, Hay'' in docket 
ID number EPA-HQ-OPP-2020-0022.

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). EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for spinetoram on the 
commodities identified in this action.

C. Revisions to Petitioned-For Tolerances

    EPA has removed the trailing zeros on the requested tolerance 
values to be consistent with Organization for Economic Co-operation and 
Development (OECD) Rounding Class Practice. EPA has also revised the 
commodity terms for fish, freshwater, finfish; fish, shellfish, 
crustacean; and fish, shellfish, mollusc to be consistent with the 
Agency's preferred vocabulary terms for these commodities; see the 
document titled ``Preferred Vocabulary for Establishing Pesticide 
Tolerances'' dated September 27, 2017 in docket ID

[[Page 72193]]

number EPA-HQ-OPP-2020-0022 at https://www.regulations.gov.

V. Conclusion

    Therefore, tolerances are established for residues of spinetoram, 
in or on fish, freshwater, finfish at 4 ppm; fish, shellfish, 
crustacean at 4 ppm; fish, shellfish, mollusc at 4 ppm; grass, forage, 
fodder and hay, group 17, forage at 10 ppm; grass, forage, fodder and 
hay, group 17, hay at 5 ppm; animal feed, nongrass, group 18, forage at 
35 ppm; and animal feed, nongrass, group 18, hay at 30 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 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: December 10, 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:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.635, amend table 1 to paragraph (a) by adding in 
alphabetical order the entries ``Animal feed, nongrass, group 18, 
forage''; ``Animal feed, nongrass, group 18, hay''; ``Fish, freshwater, 
finfish''; ``Fish, shellfish, crustacean''; ``Fish, shellfish, 
mollusc''; ``Grass, forage, fodder and hay, group 17, forage'' and 
``Grass, forage, fodder and hay, group 17, hay'' to read as follows:

Sec.  180.635  Spinetoram; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
                                                             Parts per
                        Commodity                             million
                                * * * * *
Animal feed, nongrass, group 18, forage.................              35
Animal feed, nongrass, group 18, hay....................              30
                                * * * * *
Fish, freshwater, finfish...............................               4
Fish, shellfish, crustacean.............................               4
Fish, shellfish, mollusk................................               4
                                * * * * *
Grass, forage, fodder and hay, group 17, forage.........              10
Grass, forage, fodder and hay, group 17, hay............               5
                                * * * * *

* * * * *
[FR Doc. 2021-27551 Filed 12-20-21; 8:45 am]