[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]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0022; FRL-9123-01-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 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].
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:
[[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
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/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-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-,
(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-
[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-
5(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl];oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13[[(2S,5S,6R)-
6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-2-yl-6-deoxy-3-O-ethyl-2,4-di-O-methyl-
[alpha]-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-[alpha]-L-mannopyranosyl)oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
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
above.
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
rulemaking.
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:
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 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)
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Parts per
Commodity million
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* * * * *
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
* * * * *
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[FR Doc. 2021-27551 Filed 12-20-21; 8:45 am]
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