[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Rules and Regulations]
[Pages 36666-36669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14708]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0228; FRL-8663-01-OCSPP]


Fluxapyroxad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluxapyroxad in or on the cottonseed subgroup 20C, the fruiting 
vegetable group 8-10, the pome fruit group 11-10, and pomegranate. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 13, 2021. Objections and 
requests for hearings must be received on or before September 13, 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-2020-0228, 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: 
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, 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

[[Page 36667]]

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2020-0228 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 September 13, 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-2020-0228, 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 September 30, 2020 (85 FR 61681) (FRL-
10014-74), 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 
0E8825) by IR-4, IR-4 Project Headquarters Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested that EPA establish tolerances in 40 
CFR part 180 for residues of fluxapyroxad, (BAS 700 F); 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, its metabolites, and degradates in or on the 
raw agricultural commodities: Pomegranate at 0.2 ppm; vegetable, 
fruiting, group 8-10 at 0.7 ppm; fruit, pome, group 11-10 at 0.8 ppm; 
and cottonseed subgroup 20C at 0.3 ppm. The petition also requested to 
remove the established tolerances for fluxapyroxad in or on fruit, 
pome, group 11; vegetables, fruiting, group 8; and cotton, undelinted 
seed. That document referenced a summary of the petition prepared by 
BASF, 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 one tolerance at a different level than requested. The 
reason for this change 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 fluxapyroxad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluxapyroxad 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 a number of tolerance rulemakings for 
fluxapyroxad, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to fluxapyroxad and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from those rulemakings as described 
further in this rulemaking, as they remain unchanged.
    Toxicological Profile. For a discussion of the Toxicological 
Profile of fluxapyroxad, see Unit III.A. of the May 5, 2016 rulemaking 
(81 FR 27019) (FRL-9945-48).
    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 May 5, 2016 rulemaking.
    Exposure Assessment. Much of the exposure assessment remains the 
same, although updates have occurred to accommodate exposures from the 
petitioned-for tolerances. The updates are discussed in this section; 
the remaining discussion of EPA's assumptions for exposure remain 
unchanged since the 2016 rulemaking. For a description of the rest of 
the EPA approach to and assumptions for the exposure assessment, see 
Unit III.C. of the May 5, 2016 rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new use of fluxapyroxad on pomegranate, 
and the crop group expansions to the cottonseed subgroup 20C, the 
fruiting vegetable group 8-10, and the pome fruit group 11-10. A 
partially refined acute dietary exposure analysis was performed for the 
general population and all population subgroups. Tolerance-level 
residues adjusted to account for the metabolite of concern (M700F008) 
and 100 percent crop treated (PCT) assumptions were used for all plant 
commodities. For livestock commodities, anticipated residues accounting 
for parent and the metabolites of concern (M700F008 and/or M700F010) 
were used. A moderately refined chronic dietary exposure analysis was 
performed for the general U.S. population and various population 
subgroups. Average field trial residues for parent plus maximum 
metabolite

[[Page 36668]]

residue were used for all plant commodities. For livestock commodities 
anticipated residues accounting for parent and the metabolites of 
concern (M700F008 and/or M700F010) were used. An assumption of 100 PCT 
was also used for the chronic dietary analysis.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Drinking water exposures are not impacted by the new uses, and thus 
have not changed since the last assessment in the May 5, 2016 
rulemaking.
    Safety Factor for Infants and Children. EPA continues to conclude 
that there is reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the May 
5, 2016 rulemaking for a discussion of the Agency's rationale for that 
determination.
    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.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD: They are 14% 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 
cPAD: They are 75% of the cPAD for all infants less than 1 year old, 
the population subgroup with the highest exposure estimate. The short-
term MOE is greater than the Agency's level of concern of 100: It is 
1100 for adults and 400 for children. Intermediate-term or long-term 
residential exposures are not expected.
    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 fluxapyroxad residues. More detailed information 
about the Agency's analysis can be found at http://www.regulations.gov 
in the document titled ``Fluxapyroxad. Human Health Risk Assessment for 
a Proposed Use of Fluxapyroxad on Pomegranate, Crop Group Expansion for 
Cottonseed Subgroup 20C and Crop Group Conversions for Vegetable, 
Fruiting, Group 8-10 and Fruit, Pome, and Group 11-10'' in docket ID 
number EPA-HQ-OPP-2020-0228.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate residue analytical method is available for the purpose 
of tolerance enforcement. Liquid chromatography-mass spectrometry LC/
MS/MS BASF Method L0137/01, previously deemed acceptable as an 
enforcement method for plant matrices, is applicable for the analysis 
of fluxapyroxad residues.

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 does not have an MRL for fluxapyroxad in/on pomegranate. For 
the cottonseed crop subgroup 20C, the 0.5 ppm tolerance is harmonized 
with the Codex MRL. The Agency is not harmonizing with the Codex pome 
fruit (group 11-10) MRL of 0.9 ppm because the petitioner requested 
that the tolerance remain at 0.8 ppm in order to harmonize with Canada 
and other key exporting countries. EPA also concludes that 
harmonization with the Codex fruiting vegetable (group 8-10) MRL of 0.6 
ppm is not appropriate as it could result in violative residues despite 
application consistent with approved label rates. The Codex fruiting 
vegetable MRL is based on a 7-day pre-harvest interval (PHI), not a 0-
day PHI as currently registered in the United States.

C. Revisions to Petitioned-For Tolerances

    The tolerance for the cottonseed subgroup 20C is being established 
at 0.5 ppm rather than 0.3 ppm as requested in order to harmonize with 
Codex.

V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad 
in or on the Cottonseed subgroup 20C at 0.5 ppm; Fruit, pome, group 11-
10 at 0.8 ppm; Pomegranate at 0.2 ppm; and Vegetable, fruiting, group 
8-10 at 0.7 ppm. Additionally, the existing tolerances for Cotton, 
undelinted seed; Fruit, pome, group 11; and Vegetables, fruiting, group 
8 are removed since they are superseded by the new tolerances 
established in today's action.

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). 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

[[Page 36669]]

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: July 6, 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.  180.666, paragraph (a):
0
i. Add a heading to the table;
0
ii. Remove the entry for ``Cotton, undelinted seed'';
0
iii. Add an entry for ``Cottonseed, subgroup 20C'' in alphabetical 
order;
0
iv. Remove the entry for ``Fruit, pome, group 11'';
0
v. Add entries for ``Fruit, pome, group 11-10'' and ``Pomegranate'' in 
alphabetical order;
0
vi. Remove the entry for ``Vegetables, fruiting group 8''; and
0
vii. Add an entry for ``Vegetable, fruiting, group 8-10'' in 
alphabetical order.
    The additions read as follows:


Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cottonseed, subgroup 20C....................................         0.5
 
                                * * * * *
Fruit, pome, group 11-10....................................         0.8
 
                                * * * * *
Pomegranate.................................................         0.2
 
                                * * * * *
Vegetable, fruiting, group 8-10.............................         0.7
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2021-14708 Filed 7-12-21; 8:45 am]
BILLING CODE 6560-50-P


