[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Rules and Regulations]
[Pages 72968-72971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23420]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0384; FRL-10012-78]


Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of the 
insecticide indoxacarb in or on Almond, hulls at 8 parts per million 
(ppm) and Nut, tree, group 14-12 at 0.08 ppm. FMC Corporation requested 
tolerances for these commodities under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 16, 2020. Objections and 
requests for hearings must be received on or before January 15, 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-2019-0384, 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, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: RDFRNotices@epa.gov.

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 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(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-2019-0384 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 
January 15, 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-2019-0384, 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.

[[Page 72969]]

    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 
9F8774) by FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104. 
The petition requested that 40 CFR 180.564 be amended by establishing 
tolerances for residues of the insecticide indoxacarb, [(S)-methyl 7-
chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-
phenyl]amino]carbonyl]indeno[1,2e][1,3,4]oxadiazine-4a(3H)-
carboxylate], and its R-enantiomer [(R)-methyl 7 chloro-2,5-dihydro-
2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl]indeno 
[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate], in or on Almond, hulls at 
9 parts per million (ppm) and Nut, tree, group 14-12 at 0.07 ppm. That 
document referenced a summary of the petition prepared by FMC 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. No public comments were received in response to 
the notice of filing.
    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 establishing tolerances that vary from what the petitioners sought. 
The reasons for these changes are explained in detail in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the 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 indoxacarb in or on almond, hulls and nut, tree, 
group 14-12.
    In the Federal Register on December 8, 2017 (82 FR 57860) (FRL-
9970-39), EPA published a final rule establishing a tolerance for 
residues of the insecticide indoxacarb in or on corn, field, forage; 
corn, field, grain; and corn, field, stover based on the Agency's 
determination that aggregate exposure to indoxacarb is safe for the 
U.S. general population, including infants and children. Because 
certain elements of EPA's assessment of exposures and risks associated 
with indoxacarb have not changed since the 2017 rule was published, EPA 
is incorporating the following portions of the 2017 rule as part of 
this rulemaking: the toxicological profile and points of departure/
levels of concern.

A. Exposure Assessment

    EPA has updated the exposure assessments of indoxacarb to estimate 
exposures that will result from the current and proposed new uses of 
indoxacarb in or on almond, hulls and nut, tree, group 14-12, as 
described below. Based on the current and proposed uses of indoxacarb, 
exposures can occur both from dietary sources (food + water) and in 
residential settings. An updated 2020 drinking water assessment 
utilized a total residue modeling approach to account for the 
environmental fate and transport of indoxacarb plus its degradation 
products of concern. Notwithstanding the updated 2020 drinking water 
assessment, the exposure estimates generated in the 2017 drinking water 
assessment are protective of the estimates generated from the proposed 
use of indoxacarb on tree nuts. Surface water estimated drinking water 
concentrations (EDWCs) were lower than the corresponding ground water 
EDWCs (acute EDWC of 131 parts per billion (ppb) and a chronic EDWC of 
123 ppb), which were used in the partially refined acute probabilistic 
and chronic dietary exposure assessments of indoxacarb, respectively. 
In addition, for food commodities, residue distribution files were 
constructed from field trial residues for the probabilistic acute 
dietary exposure assessment as appropriate, and average residues were 
computed for blended commodities and for the chronic dietary exposure 
assessment.
    An updated occupational and residential exposure assessment found 
no residential handler risk estimates of concern and there are no 
proposed changes to the use pattern which will impact the residential 
exposure or aggregate assessments for indoxacarb. For the currently 
registered products of indoxacarb: (1) Residential handler inhalation 
MOEs are >=92 (LOC = 30) and are not of concern; and (2) there is 
potential for residential post-application exposure for individuals 
entering an environment previously treated with indoxacarb and/or 
contact with treated pets; however, residential post-application MOEs 
are >=170 (LOC = 100) and are not of concern.

B. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an 
additional tenfold (10x) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA Safety Factor (SF). In 
applying this provision, EPA either retains the default value of 10 
times, or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    EPA determined reliable data show the safety of infants and 
children would be adequately protected if the FQPA SF were reduced to 
1x because: (1) The hazard and exposure databases are complete; (2) 
there is no susceptibility in fetuses or offspring in any of the in 
utero or postnatal toxicity studies; (3) there are no residual 
uncertainties with regard to pre- and/or postnatal toxicity; (4) the 
acute neurotoxicity, subchronic neurotoxicity, and developmental 
neurotoxicity studies are available and all endpoints used in this risk 
assessment are protective of neurotoxic effects; and (5) exposure 
estimates will not underestimate actual exposures.

C. Aggregate Risks and Determination of Safety

    For aggregate risk assessment, risk estimates resulting from food, 
drinking water, and residential uses are combined. Acute, short- and

[[Page 72970]]

intermediate-term, and long-term (chronic) aggregate assessments were 
performed for indoxacarb. Partially refined acute probabilistic and 
chronic dietary exposure assessments were conducted for all current and 
proposed new uses of indoxacarb and were found to not be of concern at 
the 99.9th percentile for the U.S. general population and all 
population subgroups: 54% of the acute population adjusted dose (aPAD) 
for children 1 to 2 years old, the group with the highest exposure 
level; and 35% of the chronic population adjusted dose (cPAD) for all 
infants, the group with the highest exposure level. Moreover, there are 
no acute, short-, intermediate- or long-term (chronic) aggregate risk 
estimates of concern for adult or child aggregate exposures to 
indoxacarb as a result of the current and proposed new uses of 
indoxacarb. For children 1 to 2 years old, the group expected to be the 
most highly exposed, the short-term aggregate margin of exposure (MOE) 
is 120 and the intermediate-/long-term aggregate MOE is 260. Because 
EPA's LOC for indoxacarb is an MOE of 100 or below, these MOEs are not 
of concern.
    Indoxacarb is classified as not likely to be carcinogenic to 
humans. Therefore, cancer risk is not a concern and cancer risks are 
not quantified.
    Based on the risk assessments and information described above, EPA 
concludes there is a reasonable certainty that no harm will result to 
the U.S. general population, or to infants and children, from aggregate 
exposure to indoxacarb residues. More detailed information on the 
subject action to establish tolerances in or on almond, hulls and nut, 
tree, group 14-12 can be found at http://www.regulations.gov in the 
document entitled ``Indoxacarb. Human Health Risk Assessment for 
Indoxacarb to Support the Proposed New Use on Almond Hulls and Tree Nut 
Group 14-12,'' dated August 20, 2020. This document can be found in 
docket ID number EPA-HQ-OPP-2019-0384.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Several adequate methods are available for enforcing indoxacarb 
tolerances on both plant and livestock commodities. Because these 
methods do not distinguish the indoxacarb enantiomers, they give a 
total measure of indoxacarb concentration. For the enforcement of 
tolerances established on crops, two high-performance liquid 
chromatograph/ultraviolet detection (HPLC/UV) methods are available for 
use. The limits of quantitation (LOQs) for these methods range from 
0.01 to 0.05 ppm for a variety of plant commodities. A third gas 
chromatograph/mass-selective detection (GC/MSD), DuPont method AMR 
3493-95 Supplement No. 4, is also available for the confirmation of 
residues in plants. In addition, a liquid chromatograph/mass 
spectrometer/mass spectrometer (LC/MS/MS) method has been developed and 
is considered an improvement to the previously approved enforcement 
method, Method DuPont-AMR-2712-93. Method DuPont-36189 has been 
determined to be adequate for enforcing tolerances established on crops 
and is reported to provide an LOQ of 0.01 ppm.
    These methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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 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. 
Although EPA may establish a tolerance that is different from a Codex 
MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for 
departing from the Codex level.
    The Codex has not established MRLs for residues of indoxacarb in or 
on almond hulls or tree nuts.

C. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance levels are different from those being 
established by EPA. These differences are attributable to the 
petitioned-for levels not being consistent with Organization for 
Economic Cooperation and Development (OECD) rounding class practice. 
The almond, hulls tolerance level is somewhat lower than the 
petitioned-for level due to the level calculated with the OECD MRL 
calculation procedures. As a result, EPA is establishing a lower 
tolerance for almond hulls at 8 ppm based on the FMC data, rather than 
the tolerance level of 9 ppm proposed by FMC Corporation.
    A tolerance level of 0.07 ppm was proposed by FMC Corporation for 
the tree nut group. EPA is establishing a tolerance level for the tree 
nut group at 0.08 ppm based on the MRL calculated for pistachios. The 
submitted field trial data for the representative tree nut crops of 
almond and pecan also included a full dataset for pistachios, which 
yielded the highest MRL in comparison to the almond and pecan 
representative crop data. In this instance, EPA considers the pistachio 
data acceptable for setting the recommended crop group tolerance on 
tree nuts because pistachios are analogous to almonds and share the 
same weed and pest pressures, are grown in the same geographic regions 
as almonds, and are a leading tree nut production crop based on total 
acreage as reported in the 2017 USDA Census of Agriculture report.

V. Conclusion

    Tolerances are established for residues of the insecticide 
indoxacarb in or on Almond, hulls at 8 parts per million (ppm) and Nut, 
tree group 14-12 at 0.08 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), 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

[[Page 72971]]

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: October 16, 2020.
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.  180.564 amend paragraph (a)(1) by designating the table as 
Table 1 paragraph (a)(1) and adding in alphabetical order to newly 
designated Table 1 to paragraph (a)(1) the entries ``Almond, hulls'' 
and ``Nut, tree, group 14-12'' to read as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

    (a) * * * (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Almond, hulls..............................................            8
 
                                * * * * *
Nut, tree, group 14-12.....................................         0.08
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-23420 Filed 11-13-20; 8:45 am]
BILLING CODE 6560-50-P


