Rule2021-14708
Fluxapyroxad; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 13, 2021
Effective
July 13, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 86 Issue 131 (Tuesday, July 13, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#66342220342809120f0503152603160748010910"><span class="__cf_email__" data-cfemail="16445250445879627f7573655673667738717960">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl">http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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, <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>
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
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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
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