[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Rules and Regulations]
[Pages 31386-31389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10483]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0384; FRL-9995-89]


Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of the 
insecticide indoxacarb in or on corn, pop, grain at 0.02 parts per 
million (ppm) and corn, pop, stover at 15 ppm. FMC Corporation 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective May 26, 2020. Objections and 
requests for hearings must be received on or before July 27, 2020, 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. 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. Please review the visitor instructions and additional 
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, 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).

[[Page 31387]]

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-2019-0384 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 
July 27, 2020. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b). 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.
    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 25, 2020 (85 FR 10642) (FRL-
10000-85), EPA issued a document pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a revised pesticide 
petition (PP 8F8708) 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 corn, pop, grain at 0.02 parts per million (ppm) and corn, pop, 
stover at 15 ppm. That document referenced a corrected summary of the 
petition prepared by FMC Corporation, the registrant, which is 
available in the docket, http://www.regulations.gov.
    EPA published this document in response to a comment received from 
FMC Corporation in response to a previously published notice of filing 
of August 2, 2019. In a comment submitted in response to that August 2, 
2019 document, FMC Corporation noted that the August 2, 2019 notice 
indicated that E.I. du Pont de Nemours had filed the petition and that 
the incorrect petition summary was contained in the docket. EPA also 
noticed that the originally submitted petition did not actually request 
tolerances for residues of indoxacarb in or on popcorn commodities, 
despite the intent to do so. As a result, FMC Corporation submitted a 
revised petition, including a corrected summary of the petition, to 
correct the original notice error. One public comment was received in 
response to the corrected notice of filing. EPA's response to this 
comment is discussed in Unit IV.C.
    Based upon review of the data supporting the referenced petition, 
EPA is establishing a tolerance for residues of indoxacarb in or on 
corn, pop, grain and corn, pop, stover.

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 indoxacarb in or on corn, pop, 
grain and corn, pop, stover.
    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 the 
toxicity profile for indoxacarb has not changed since that last rule 
was published, EPA is incorporating the discussion of that profile 
(Unit III.A.) and the identified toxicological endpoints (Unit III.B.) 
as part of this rulemaking.
    EPA's 2017 exposure assessment remains current in providing an up-
to-date assessment of indoxacarb, as that assessment included exposures 
to indoxacarb in or on popcorn commodities as reflected in this 
document. Based on the current and newly proposed uses of indoxacarb in 
or on corn, pop, grain and corn, pop, stover, exposures can occur both 
from dietary sources (food + water) and in residential settings. For 
aggregate risk assessment, risk estimates resulting from food, drinking 
water, and residential uses are combined. Acute, short-and 
intermediate-term, and long-term (chronic) aggregate assessments were 
performed for indoxacarb. Further information about EPA's risk 
assessment and determination of safety supporting the tolerances 
established in the

[[Page 31388]]

December 8, 2017 Federal Register action, as well as the new indoxacarb 
tolerances can be found at http://www.regulations.gov in the documents 
entitled ``Indoxacarb: Human Health Risk Assessment for Indoxacarb to 
Support the Proposed New Uses on Corn (Field, Pop, and Grown for 
Seed),'' dated October 24, 2017 (docket ID EPA-HQ-OPP-2017-0095), and 
``Indoxacarb. Section 3 Registration for the New Use of Indoxacarb on 
Popcorn. Abbreviated Residue Chemistry Review,'' dated September 16, 
2019 (docket ID EPA-HQ-OPP-2019-0384), respectively.
    The acute dietary risk estimates determined for indoxacarb (food + 
water) were found not to be of concern at the 99.9th exposure 
percentile for the U.S. general population and all population subgroups 
and are below the Agency's LOC (<100% of the acute population adjusted 
dose (aPAD)). In addition, the chronic dietary risk estimates 
determined for indoxacarb (food + water) were found not to be of 
concern for the U.S. general population and all population subgroups 
and are below the Agency's LOC (<100% of the chronic population 
adjusted dose (cPAD)). As indicated in the supporting documents, the 
acute and chronic dietary risks are below the Agency's level of 
concern: 56% of the aPAD for children 1-2 years old, the group with the 
highest exposure level; 35% of the cPAD for all infants (less than 1 
year old), the group with the highest exposure level.
    The acute aggregate assessment is based on food + drinking water 
exposures only, because there are no acute residential exposures 
expected. For the short-, intermediate- and long-term (chronic) 
aggregates, the highest non-dietary exposure scenarios were selected as 
being protective of all other potential exposure scenarios--these were 
from spot treatments to carpets [coarse and pin stream] for short-term 
exposures, and from spot-on treatments of dogs for intermediate- and 
long-term exposures. There are no acute, short-term, intermediate-term, 
or long-term (chronic) aggregate risk estimates of concern for adult or 
child aggregate exposure to indoxacarb as a result of the current and 
proposed uses (short-term aggregate margin of exposure (MOE) = 120; 
intermediate-/long-term aggregate MOE = 260) because EPA considers MOEs 
of less than 100 to be of concern for aggregate 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 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 corn, pop, grain 
and corn, pop, stover can be found at http://www.regulations.gov in the 
document entitled ``Indoxacarb. Section 3 Registration for the New Use 
of Indoxacarb on Popcorn. Abbreviated Residue Chemistry Review.'' This 
document can be found in docket ID number EPA-HQ-OPP-2019-0384.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For the enforcement of tolerances established on crops, two High 
Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV) 
methods, DuPont protocols AMR 2712-93 and DuPont-11978, 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 procedure, 
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.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., 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). 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. The Codex has not 
established MRLs in corn, pop, grain and corn, pop, stover for 
indoxacarb.

C. Response to Comments

    EPA received one public comment in response to the corrected notice 
of filing, generally opposed to any indoxacarb residues in or on corn, 
pop, grain and corn, pop, stover. Although the Agency recognizes that 
some individuals believe that pesticides should be banned on 
agricultural crops, the existing legal framework provided by section 
408 of the FFDCA states that tolerances may be set when persons seeking 
such tolerances or exemptions have demonstrated that the pesticide 
meets the safety standard imposed by that statute. This comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the comment provides no information relevant to the Agency's 
safety determination.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide indoxacarb in or on corn, pop, grain at 0.02 parts per 
million (ppm) and corn, pop, stover at 15 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 
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

[[Page 31389]]

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: May 7, 2020.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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, add alphabetically the entries ``Corn, pop, 
grain'' and ``Corn, pop, stover'' to the table in paragraph (a) to read 
as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, pop, grain........................................            0.02
Corn, pop, stover.......................................              15
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2020-10483 Filed 5-22-20; 8:45 am]
BILLING CODE 6560-50-P


