[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Rules and Regulations]
[Pages 17907-17910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07186]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0526; FRL-10020-24]


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 that are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 7, 2021. Objections and 
requests for hearings must be received on or before June 7, 2021 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-2019-0526, is available at http://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:

[[Page 17908]]

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 Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2019-0526 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 
June 7, 2021. 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-2019-0526, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), 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 
9E8778) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the insecticide 
spinetoram, including its metabolites and degradates in or on the raw 
agricultural commodities dragon fruit at 1.5 ppm; vegetable, Brassica, 
head and stem, group 5-16 at 2.0 ppm; kohlrabi at 2.0 ppm; Brassica, 
leafy greens, subgroup 4-16B at 10 ppm; leafy greens subgroup 4-16A at 
8.0 ppm; leaf petiole vegetable subgroup 22B at 8.0 ppm; celtuce at 8.0 
ppm; fennel, Florence, fresh leaves and stalk at 8.0 ppm; and berry, 
low growing, except strawberry, subgroup 13-07H at 0.04 ppm. The 
petition also requested to amend 40 CFR 180.635 by removing the 
following spinetoram tolerances: Brassica, head and stem, subgroup 5A 
at 2.0 ppm; Brassica, leafy greens, subgroup 5B at 10 ppm; vegetable, 
leafy, except Brassica, group 4 at 8 ppm; and cranberry at 0.04 ppm. 
That document referenced a summary of the petition prepared by Dow 
AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing several tolerances at different levels than requested. The 
reasons for these changes are 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 in FFDCA section 408(b)(2)(D), 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 republishing the same sections is 
unnecessary. 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 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 that 
remain unchanged from

[[Page 17909]]

those rulemakings as described further in this rulemaking.
    Toxicological Profile. For a discussion of the Toxicological 
Profile of spinetoram, see Unit III.A. of the August 8, 2018 rulemaking 
(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, see Unit III.B. of the August 8, 2018 rulemaking.
    Exposure Assessment. Much of the exposure assessment remains 
unchanged from the previous rulemaking, although the new exposure 
assessment incorporates the additional dietary exposure from the 
petitioned-for tolerances. The residue levels, percent crop treated, 
and estimated drinking water concentrations used in the exposure 
assessment remain the same and are discussed in Unit III.C. of the 
August 8, 2018 rulemaking. Moreover, there have been no changes to 
residential exposures, so the Agency's approach for assessing 
residential (non-occupational, non-dietary exposures) is also discussed 
in that same Unit. Finally, the Agency's conclusions about cumulative 
effects remain the same as in that Unit.
    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 FQPA SF were reduced from 
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 
aggregate exposure estimates to the acute population adjusted dose 
(aPAD) and chronic PAD (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 analysis 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 780 for adults. These MOEs do not exceed the target level 
of concern of 100. 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 
http://www.regulations.gov in the document titled ``Spinosad/
Spinetoram. Human Health Risk Assessment in Support of Proposed 
Spinetoram Tolerance for Residues in/on Imported Tea'' dated January 
16, 2018 in docket ID EPA-HQ-OPP-2017-0352 and the document titled 
``Spinosad and Spinetoram. Human Health Risk Assessment for Proposed 
Use on Dragon Fruit (Pitaya); Crop Group Expansion for Berry, Low 
Growing, Except Strawberry, Subgroup 13-07H; and Crop Group Conversions 
for Vegetable, Brassica, Head and Stem, Group 5-16; Brassica, Leafy 
Greens, Subgroup 4-16B; Leaf Petiole Vegetable Subgroup 22B; Leafy 
Greens Subgroup 4-16A; Celtuce; Fennel, Florence, Fresh Leaves and 
Stalk; and Kohlrabi.'' dated February 12, 2021 in docket ID number EPA-
HQ-OPP-2019-0526.

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). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. 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.
    There are no Codex MRLs established for dragon fruit; berry, low 
growing, except strawberry, subgroup 13-07H; Brassica, leafy greens, 
subgroup 4-16B; celtuce; and fennel, Florence, fresh leaves and stalk.
    The U.S. tolerances for kohlrabi and leafy greens subgroup 4-16A 
are harmonized with the Codex MRLs.
    For two crop groups, the Codex MRL is lower than the U.S. 
tolerance: Leaf petiole vegetable subgroup 22B at 6 ppm instead of 8 
ppm and for vegetable, Brassica, head and stem, group 5-16 at 0.3 ppm 
rather than 2 ppm. Harmonization of these tolerances is not possible 
because decreasing the U.S. tolerances to harmonize with the Codex MRL 
would put U.S. growers at risk of having violative residues despite 
legal use of the pesticide according to the label.

C. Revisions to Tolerances

    Based upon review of the data supporting the petition, EPA is 
establishing tolerance levels consistent with Organization for Economic 
Cooperation and Development (OECD) Rounding Class Practice.
    The petitioner requested separate subgroup tolerances for the 
Brassica, leafy greens, subgroup 4-16B at 10 ppm and leafy greens 
subgroup 4-16A at 8.0 ppm. EPA has decided to establish a single group 
tolerance for the vegetable, leafy, group 4-16 at 10 ppm to harmonize 
with Codex.

V. Conclusion

    Therefore, tolerances are established for residues of spinetoram in 
or on berry, low growing, except strawberry, subgroup 13-07H at 0.04 
ppm; celtuce at 8 ppm; dragon fruit at 1.5 ppm; fennel, Florence, fresh 
leaves and stalk at 8 ppm; kohlrabi at 2 ppm; leaf petiole vegetable 
subgroup 22B at 8 ppm; vegetable, Brassica, head and stem, group 5-16 
at 2 ppm; and vegetable, leafy, group 4-16 at 10 ppm.
    Additionally, the following tolerances are removed as unnecessary 
due to the establishment of the above tolerances: Brassica, head and 
stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; cranberry; and 
vegetable, leafy, except Brassica, group 4.

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

[[Page 17910]]

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), nor is 
it considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). 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 and 
modifications 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: March 5, 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 the table in paragraph (a) as follows:
0
i. Add a table heading;
0
ii. Add alphabetically an entry for ``Berry, low growing, except 
strawberry, subgroup 13-07H'';
0
iii. Remove the entries for ``Brassica, head and stem, subgroup 5A''; 
and ``Brassica, leafy greens, subgroup 5B'';
0
iv. Add alphabetically an entry for ``Celtuce'';
0
v. Remove the entry for ``Cranberry'';
0
vi. Add alphabetically entries for ``Dragon fruit''; ``Fennel, 
Florence, fresh leaves and stalk''; ``Kohlrabi''; ``Leaf petiole 
vegetable subgroup 22B''; ``Vegetable, Brassica, head and stem, group 
5-16''; and ``Vegetable, leafy, except Brassica, group 4''; and
0
vii. Remove the entry for ``Vegetable, leafy, group 4-16''.
    The additions read as follows:


Sec.  180.635   Spinetoram; tolerances for residue.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H......        0.04
 
                                * * * * *
Celtuce.....................................................           8
 
                                * * * * *
Dragon fruit................................................         1.5
 
                                * * * * *
Fennel, Florence, fresh leaves and stalk....................           8
 
                                * * * * *
Kohlrabi....................................................           2
Leaf petiole vegetable subgroup 22B.........................           8
 
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............           2
Vegetable, leafy, group 4-16................................          10
 
                                * * * * *
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[FR Doc. 2021-07186 Filed 4-6-21; 8:45 am]
BILLING CODE 6560-50-P