[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Rules and Regulations]
[Pages 36755-36758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11516]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0386; FRL-10009-14]


Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and amends tolerances for residues 
of fenpyroximate in or on multiple commodities which 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 June 18, 2020. Objections and 
requests for hearings must be received on or before August 17, 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-2019-0386, is available online at 
http://www.regulations.gov or in-person 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 note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit 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: [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:
     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-2019-0386 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 
August 17, 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 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-2019-0386, online 
through the Federal eRulemaking Portal at http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any

[[Page 36756]]

information you consider to be CBI or other information whose 
disclosure is restricted by statute.
    Please note, that due to the public health emergency, the EPA 
Docket Center and Reading Room was closed to public visitors on March 
31, 2020, and there is a temporary suspension of mail delivery to EPA 
(including hand deliveries). Our Docket Center staff will continue to 
provide customer service via email, phone, and webform. For further 
information on EPA Docket Center services, docket contact information 
and the current status of the EPA Docket Center and Reading Room, 
please visit https://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 
9E8766) 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 to establish tolerances for 
residues of fenpyroximate, including its metabolites and degradates, in 
or on the raw agricultural commodities peanut at 0.04 parts per million 
(ppm); peanut, hay at 30 ppm; and tropical and subtropical, medium to 
large fruit, smooth, inedible peel, subgroup 24B, except banana at 0.6 
ppm. Additionally, the petition requested to amend 40 CFR 180.566 by 
removing the established tolerances for residues of fenpyroximate in or 
on the raw agricultural commodities avocado at 0.15 ppm; canistel at 
0.15 ppm; mango at 0.15 ppm; papaya at 0.15 ppm; sapote, black at 0.15 
ppm; and star apple at 0.15 ppm. That document referenced a summary of 
the petition prepared by Nichino America, the registrant, which is 
available in the docket, http://www.regulations.gov. No comments were 
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what was requested. 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 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 fenpyroximate including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenpyroximate 
follows.
    On December 5, 2019, EPA published in the Federal Register a final 
rule establishing tolerances for residues of fenpyroximate in or on 
multiple agricultural commodities based on the Agency's conclusion that 
aggregate exposure to fenpyroximate is safe for the general population, 
including infants and children. See (84 FR 66620) (FRL-10002-00). That 
document contains a summary of the toxicological profile and points of 
departure, assumptions for exposure assessment, cumulative risk, and 
the Agency's determination regarding the children's safety factor, 
which have not changed.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new uses of fenpyroximate on peanuts, 
peanut hay, and the tropical and subtropical, medium to large fruit, 
smooth, inedible peel subgroup 24B, except banana, including increased 
residues in livestock resulting from these uses. The assessment relies 
on tolerance-level residues for all crops for the acute and chronic 
dietary assessments and assumes 100 percent crop treated (PCT) for the 
acute assessment and utilizes percent crop treated estimates for some 
commodities for the chronic assessment. EPA's aggregate exposure 
assessment incorporated this additional assumed dietary exposure, as 
well as exposure in drinking water, although this latter exposure is 
not impacted by the new tolerances and thus have not changed since the 
last assessment. Further information about EPA's risk assessment and 
determination of safety supporting the tolerances established in the 
December 5, 2019 Federal Register action as well as these new 
fenpyroximate tolerances can be found at http://www.regulations.gov in 
the document titled ``Fenpyroximate: Human Health Risk Assessment for 
Registration Review and a Petition to Establish Tolerances for Residues 
in/on the Banana; Leaf Petiole Vegetable Subgroup 22B; Caneberry 
Subgroup 13-07A; Bushberry Subgroup 13-07B; Squash/Cucumber Subgroup 
9B; and Succulent Shelled Beans; and Crop Group Conversions for Nut, 
Tree, Group 14-12; and Cottonseed Subgroup 20C,'' dated September 12, 
2019 in docket ID EPA-HQ-OPP-2018-0162 and the document titled 
``Fenpyroximate: Human Health Risk Assessment to Support the Petition 
for Tolerance for Residues in/on Peanuts and Tropical and Subtropical, 
Medium to Large Fruit, Smooth, Inedible Peel, Subgroup 24B, Except 
Banana,'' dated March 15, 2020 in docket ID number EPA-HQ-OPP-2019-
0386.
    Acute dietary (food and water) risks are below the Agency's level 
of concern of 100% of the acute population adjusted dose (aPAD): 8.6% 
of the aPAD for children 1 to 2 years old, the population subgroup with 
the highest exposure estimate. Chronic dietary risks are below the 
Agency's level of concern of 100% of the chronic population adjusted 
dose (cPAD): 62% of the cPAD for children 1 to 2 years old, the 
population subgroup with the highest exposure estimate. There are no 
residential uses for fenpyroximate; therefore, no short- or 
intermediate-term assessment was necessary. Aggregate risk is comprised 
solely of the dietary exposures, which are all below EPA's levels of 
concern.
    Therefore, 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography method with 
nitrogen/phosphorus detection (GC/NPD), Method S19) is available to 
enforce the tolerance expression. A data-gathering liquid 
chromatography/mass spectroscopy/mass spectroscopy (LC/MS/MS) method is 
also available.

[[Page 36757]]

    The methods 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: 
[email protected].

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 established Codex MRLs for residues of fenpyroximate 
in peanut or peanut hay. A Codex MRL is established for residues of 
fenpyroximate (parent compound only) in avocados at a lower level (0.15 
ppm) than the new U.S. tolerance on the tropical and subtropical, 
medium to large fruit, smooth, inedible peel subgroup 24B, except 
banana, of which avocados is a part (0.6 ppm). Harmonization with the 
Codex MRL is not possible because the U.S. tolerance expression 
includes the parent compound and an additional isomer and because the 
U.S. use patterns require higher numerical values for the crop subgroup 
in order to avoid potential tolerance exceedances when label directions 
are followed.

C. Revisions to Petitioned-For Tolerances

    As part of the review of the petition, a revised maximum reasonable 
dietary burden (MRDB), including the potential contribution of peanut 
hay was evaluated. As indicated in EPA's regulation, 40 CFR 180.6, when 
finite pesticide chemical residues will be found in livestock 
commodities as a result of the use of a pesticide in or on animal 
feedstuffs, EPA will establish tolerances in livestock commodities to 
accommodate those residues. The additional uses of fenpyroximate on 
peanut (and residues on peanut, hay) result in an increase in the MRDB 
for beef and dairy cattle and consequently necessitate increasing 
tolerances for fenpyroximate residues in ruminant commodities. New 
tolerance levels in ruminant commodities were determined using the 
Langmuir model, and based on that analysis, EPA is increasing existing 
cattle, goat, horse, and sheep tolerances as follows: Fat 0.03 ppm to 
0.1 ppm, liver 0.25 ppm to 0.7 ppm, and kidney 0.25 ppm to 0.5 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
fenpyroximate, including its metabolites and degradates, in or on 
peanut, hay at 30 ppm; peanut, at 0.04 ppm; and the tropical and 
subtropical, medium to large fruit, smooth, inedible peel subgroup 24B, 
except banana at 0.6 ppm.
    Additionally, the following existing tolerances are increased as 
follows: Cattle, fat from 0.03 ppm to 0.1 ppm; cattle, kidney from 0.25 
ppm to 0.5 ppm; cattle, liver from 0.25 ppm to 0.7 ppm; goat, fat from 
0.03 ppm to 0.1 ppm; goat, kidney from 0.25 ppm to 0.5 ppm; goat, liver 
from 0.25 ppm to 0.7 ppm; horse, fat from 0.03 ppm to 0.1 ppm; horse, 
kidney from 0.25 ppm to 0.5 ppm; horse, liver from 0.25 ppm to 0.7 ppm; 
sheep, fat from 0.03 ppm to 0.1 ppm; sheep, kidney from 0.25 ppm to 0.5 
ppm; and sheep, liver from 0.25 ppm to 0.7 ppm.
    Also, the following tolerances are removed as unnecessary due to 
the establishment of the above tolerances: Avocado; canistel; mango; 
papaya; sapote, black; and star apple.
    Lastly, EPA is removing, as a housekeeping measure, an expired 
section 18 tolerance on honey since it expired on December 31, 2013 and 
is no longer valid.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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 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 (CRA)

    Pursuant to the CRA (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

[[Page 36758]]

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 11, 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.  180.566:
0
a. In paragraph (a)(1):
0
i. Add a heading for the table.
0
ii. Remove the entries for ``Avocado''; ``Canistel''; ``Mango''; and 
``Papaya''.
0
iii. Add alphabetically the entries ``Peanut'' and ``Peanut, hay''.
0
iv. Remove the entries for ``Sapote, black'' and ``Star, apple''.
0
v. Add alphabetically the entry for ``Tropical and subtropical, medium 
to large fruit, smooth, inedible peel subgroup 24B, except banana''.
0
b. In paragraph (a)(2):
0
i. Add a heading for the table.
0
ii. Revise the entries for ``Cattle, fat''; ``Goat, fat''; ``Horse, 
fat''; and ``Sheep, fat''.
0
c. In paragraph (a)(3), revise the table.
0
d. Remove and reserve paragraph (b).
    The additions and revisions read as follows:


Sec.  180.566  Fenpyroximate; tolerances for residues.

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

                       Table 1 of Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Peanut......................................................        0.04
Peanut, hay.................................................          30
 
                                * * * * *
Tropical and subtropical, medium to large fruit, smooth,             0.6
 inedible peel subgroup 24B, except banana..................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (2) * * *

                       Table 2 of Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................         0.1
 
                                * * * * *
Goat, fat...................................................         0.1
 
                                * * * * *
Horse, fat..................................................         0.1
 
                                * * * * *
Sheep, fat..................................................         0.1
 
                                * * * * *
------------------------------------------------------------------------

    (3) * * *

                       Table 3 of Paragraph (a)(3)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, kidney..............................................         0.5
Cattle, liver...............................................         0.7
Goat, kidney................................................         0.5
Goat, liver.................................................         0.7
Horse, kidney...............................................         0.5
Horse, liver................................................         0.7
Sheep, kidney...............................................         0.5
Sheep, liver................................................         0.7
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-11516 Filed 6-17-20; 8:45 am]
BILLING CODE 6560-50-P