[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8454-8457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02238]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0694; FRL-10004-23]


Cyantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
cyantraniliprole in or on strawberry. The Interregional Research 
Project No. 4 (IR-4) requested this tolerance under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 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-2017-0694, 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. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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: 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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select ``Test Methods and Guidelines.''

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-2017-0694 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 
April 14, 2020. 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

[[Page 8455]]

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-2017-0694, 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/where-send-comments-epa-dockets.
    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 August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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 
9E8739) by The Interregional Research Project No. 4 (IR-4), Rutgers, 
The State University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.672 be 
amended by establishing a tolerance for residues of the insecticide, 
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on 
strawberry at 1.5 parts per million (ppm). Upon the establishment of 
the above tolerance, IR-4 proposed to remove the existing tolerance in 
40 CFR 180.672 in or on strawberry at 1.0 ppm. That document referenced 
a summary of the petition prepared by DuPont Crop Protection, the 
registrant, which is available in the docket, https://www.regulations.gov. No comments were received on the notice of filing.

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 cyantraniliprole including 
exposure resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with cyantraniliprole 
follows.

A. Toxicological Profile and Points of Departure/Levels of Concern

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    A summary of the toxicological profile for cyantraniliprole is 
discussed in Unit III.A. of the final rule published in the Federal 
Register of November 13, 2018 (84 FR 56262) (FRL-9985-32). A summary of 
the toxicological endpoints for cyantraniliprole used for human risk 
assessment is discussed in Unit III.B of the final rule published in 
the Federal Register of February 5, 2014 (79 FR 6826) (FRL-9388-7).
    Specific information on the studies received and the nature of the 
adverse effects caused by cyantraniliprole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Cyantraniliprole. Human Health Risk 
Assessment for Proposed Uses and Tolerance Requests on Coffee; 
Caneberry Subgroup 13-07A; Low Growing Berry Subgroup 13-07H, Except 
Strawberry, Lowbush Blueberry and Lingonberry; Brassica Leafy Greens 
Subgroup 4-16A; Leafy Greens Subgroup 4-16B; Brassica Head and Stem 
Vegetable Group 5-16; Leaf Petiole Vegetable Subgroup 22B; Celtuce; 
Florence Fennel; Kohlrabi; Rice; Soybean; and Aspirated Grain 
Fractions'' on pages 36-45 in docket ID number EPA-HQ-OPP-2017-0694.

B. Exposure Assessment

    A summary of EPA's consideration of dietary exposure under the 
petitioned-for tolerance as well as existing cyantraniliprole 
tolerances, as well as non-dietary exposure and exposure to substances 
with a common mechanism of toxicity is discussed in Unit III.C. of the 
November 13, 2018 final rule published in the Federal Register.

C. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of 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 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    EPA has determined that reliable data show the safety of infants 
and children would be adequately protected if the FQPA SF were reduced 
to 1X. That decision is based on the findings summarized in Unit III.D. 
of the November 13, 2018 final rule.

D. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking

[[Page 8456]]

water. No adverse effect resulting from a single oral exposure was 
identified and no acute dietary endpoint was selected. Therefore, 
cyantraniliprole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions cited in this unit 
for chronic exposure, EPA has concluded that chronic exposure to 
cyantraniliprole from food and water will utilize 99% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation cited in Unit III.B., regarding 
residential use patterns, chronic residential exposure to residues of 
cyantraniliprole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). 
Cyantraniliprole is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to cyantraniliprole.
    Using the exposure assumptions cited in this unit for short-term 
exposures, EPA has concluded the combined short-term food, water, and 
residential exposures result in an aggregate MOE of 149 for children 1 
to 2 years old. For adults, the oral and inhalation routes of exposure 
are not appropriate to be aggregated since the endpoints of concern are 
not common. Because EPA's level of concern for cyantraniliprole is an 
MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Cyantraniliprole is currently registered for uses that could 
result in intermediate-term residential exposure, however, the short-
term aggregate risk estimate described above is protective of potential 
intermediate-term exposures and risks in children.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyantraniliprole is not expected to pose a cancer risk to 
humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to cyantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance 
expression.
    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.
    Codex has not established an MRL for cyantraniliprole residues in 
or on strawberry.

V. Conclusion

    Therefore, the existing tolerance for residues of cyantraniliprole, 
3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-
[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on 
strawberry is modified from 1.0 ppm to 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This action modifies a tolerance 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 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).

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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: January 24, 2020.
Michael 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.  180.672, revise the entry for ``Strawberry'' in the table 
in paragraph (a) to read as follows:


Sec.  180.672  Cyantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Strawberry..................................................         1.5
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2020-02238 Filed 2-13-20; 8:45 am]
BILLING CODE 6560-50-P


