Rule2023-17430
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
August 16, 2023
Effective
August 16, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of fluxapyroxad in or on avocado; stevia, dried leaves; and stevia, fresh leaves and revises the tolerance for residues of fluxapyroxad in or on coffee, green bean. Interregional Project Number 4 (IR-4) and BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 157 (Wednesday, August 16, 2023)</title>
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[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Rules and Regulations]
[Pages 55578-55581]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17430]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0234 and EPA-HQ-OPP-2022-0258; FRL-10679-01-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 avocado; stevia, dried leaves; and stevia, fresh
leaves and revises the tolerance for residues of fluxapyroxad in or on
coffee, green bean. Interregional Project Number 4 (IR-4) and BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 16, 2023. Objections and
requests for hearings must be received on or before October 16, 2023,
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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2022-0234 and EPA-HQ-OPP-2022-
0258, are available at <a href="https://www.regulations.gov">https://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 and the OPP Docket is
(202) 566-1744. For the latest status information on EPA/DC services,
docket access, visit <a href="https://www.epa.gov/">https://www.epa.gov/</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#c1938587938faeb5a8a2a4b281a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="14465052465a7b607d777167547164753a737b62">[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 Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
[[Page 55579]]
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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 numbers EPA-HQ-OPP-2022-0234 and EPA-HQ-OPP-2022-0258 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 October 16, 2023. 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 numbers EPA-HQ-OPP-2022-0234 and EPA-
HQ-OPP-2022-0258, by one of the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://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="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
12-OCSPP), 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
1E8980) by IR-4 Project Headquarters, North Carolina State University,
1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The
petition requested that 40 CFR 180.666 be amended to establish
tolerances for residues of the fungicide fluxapyroxad, 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide in or on stevia, dried leaves at 60 parts per
million (ppm) and stevia, fresh leaves at 20 ppm and to revise the
established tolerance in or on coffee, green bean at 0.2 ppm to remove
the footnote indicating a tolerance without U.S. registrations. That
document referenced a summary of the petition prepared by IR-4, which
is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. One comment
was received in response to the notice of filing. EPA's response to
this comment is discussed in Unit. IV.C.
In the Federal Register of July 20, 2022 (87 FR 43231) (FRL-9410-
03-OCSPP), 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
1F8974) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.666 be amended to
establish a tolerance for residues of the fungicide fluxapyroxad, 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide in or on avocado at 0.6 ppm. One comment was
received in response to the notice of filing. EPA's response to this
comment is discussed in Unit. IV.C.
Based upon review of the data supporting the petition, EPA is
establishing two tolerances at a different level than the petitioners
requested. The reasons for these changes are explained in Unit IV.D.
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 therein, 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 for 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 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.
[[Page 55580]]
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of fluxapyroxad on avocado,
coffee, and stevia. A partially refined acute dietary exposure analysis
was performed for the general population and all population subgroups.
Tolerance level residues were 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 partially 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 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.
The new uses do not result in an increase in the estimated residue
levels in drinking water, so EPA used the same estimated drinking water
concentrations in the acute and chronic dietary exposure assessments as
identified in Unit III.C.2. of the May 5, 2016, rulemaking.
The new uses do not impact residential exposures and thus the
residential exposures have not changed since the last assessment
described in the May 5, 2016, rulemaking.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to fluxapyroxad and any other substances. For
the purposes of this action, therefore, EPA has not assumed that
fluxapyroxad has a common mechanism of toxicity with other substances.
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 from 10X to 1X. 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
dietary exposure estimates to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by comparing the estimated total food,
water, and residential exposure to the appropriate points of departure
(PODs) to ensure that an adequate margin of exposure (MOE) exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD. They are 15% 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 94% of the cPAD for all infants less than 1 year old,
the population subgroup with the highest exposure estimate.
The short-term aggregate exposure assessment for children 1 to less
than 2 years old includes dietary (food and drinking water) and
incidental oral exposure from hand-to-mouth activities from post-
application exposure to turf applications. For adults, the short-term
aggregate exposure assessment includes dietary (food and drinking
water) and inhalation exposure during application to turf using a
backpack sprayer. The short-term MOEs are greater than the Agency's
level of concern of 100 and therefore are not of concern. They are
1,100 for adults and 400 for children.
There are no residential use scenarios that would result in
potential intermediate-term exposure to fluxapyroxad; therefore, an
intermediate-term aggregate risk assessment is not required.
There are no residential use scenarios that would result in
potential long-term (chronic) exposure; therefore, the chronic
aggregate risk is equivalent to the chronic dietary (food and water)
risk, and there are no risks of concern.
Fluxapyroxad has been classified as ``not likely to be carcinogenic
to humans below a defined dose range.'' The Agency has determined that
the quantification of risk using a non-linear approach (i.e., reference
dose or RfD) will adequately account for all chronic toxicity,
including carcinogenicity, that could result from exposure to
fluxapyroxad and, as indicated above, there are no chronic risks of
concern for fluxapyroxad.
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="https://www.regulations.gov">https://www.regulations.gov</a>
in the document titled ``Fluxapyroxad. Human Health Risk Assessment for
the Section 3 Registrations Proposing Use on Avocado, Coffee (green
bean); Stevia (dried leaves), and Stevia (fresh leaves)'' in docket ID
numbers EPA-HQ-OPP-2022-0234 and EPA-HQ-OPP-2022-0258.
IV. Other Conclusions
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A of the July 13, 2021, rulemaking (86 FR 36666) (FRL-8663-
01).
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 MRLs for residues of fluxapyroxad in or on
avocado or stevia. It is not possible to harmonize the U.S. tolerance
of 0.2 ppm for residues in or on coffee, green bean with the Codex MRL
of 0.15 ppm because establishing the tolerance at the lower level may
result in exceedances for U.S. growers despite compliance with U.S.
label instructions.
C. Response to Comments
Two comments were received in response to the Notices of Filing.
One comment stated in part that the Agency
[[Page 55581]]
should not approve the petitions because of the ``further pollution of
the air water soil of this earth'' and the other expressed similar
sentiments. 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
authorizes EPA to establish tolerances when it determines that the
tolerances are safe. Upon consideration of the validity, completeness,
and reliability of the available data as well as other factors the
FFDCA requires EPA to consider, EPA has determined that the
fluxapyroxad tolerances are safe. The commenter has provided no
information indicating that a safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances
A tolerance of 1.5 ppm is being established for avocado rather than
0.6 ppm as requested. This reflects the use of proportionality to
adjust the field trial residue data to the labeled rate because the
field trials were conducted at 0.5x the labeled single/seasonal rate. A
tolerance of 70 ppm is being established for stevia, dried leaves
rather than the petitioned for tolerance of 60 ppm because EPA used the
highest residue from the residue decline trial for calculations rather
than the residue at the labeled pre-harvest interval.
V. Conclusion
Therefore, tolerances are established for residues of fluxapyroxad
in or on avocado at 1.5 ppm; stevia, dried leaves at 70 ppm; and
stevia, fresh leaves at 20 ppm. In addition, the established tolerance
for residues of fluxapyroxad in or on coffee, green bean at 0.2 ppm is
revised to remove the footnote indicating a tolerance without U.S.
registrations.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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 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
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: August 8, 2023.
Charles Smith,
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, in paragraph (a) amend table 1 by:
0
a. Adding in alphabetical order the entry ``Avocado'';
0
b. Revising the entry ``Coffee, green bean'';
0
c. Adding in alphabetical order the entries ``Stevia, dried leaves''
and ``Stevia, fresh leaves''.
The additions and revision read as follows:
Sec. 180.666 Fluxapyroxad; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Avocado..................................................... 1.5
* * * * *
Coffee, green bean.......................................... 0.2
* * * * *
Stevia, dried leaves........................................ 70
Stevia, fresh leaves........................................ 20
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-17430 Filed 8-15-23; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.