[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Rules and Regulations]
[Pages 10242-10244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03399]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0658; FRL-10474-01-OCSPP]
Penthiopyrad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
penthiopyrad in or on banana. Interregional Research Project Number 4,
IR-4, requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective February 17, 2023. Objections and
requests for hearings must be received on or before April 18, 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 docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0658, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744.
For the latest status information on EPA/DC services, docket
access, visit https://www.epa.gov/.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 506-2875; 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 Office of the
Federal Register's e-CFR site at https://www.ecfr.gov//title-40.
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-2021-0658 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
April 18, 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 number EPA-HQ-OPP-2021-0658, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of November 17, 2022 (87 FR 68959) (FRL-
9410-07-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 1E8951) by IR-4, NC State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that
40 CFR 180.658 be amended to establish a tolerance for residues of the
fungicide penthiopyrad, N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-
(trifluoromethyl)-1H-pyrazole-4-carboxamide, in or on banana at 2 parts
per million (ppm). That document referenced a summary of the petition
prepared by IR-4, the petitioner, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the Notice of Filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing the tolerance for residues of penthiopyrad in or on
banana at a different level than requested by the petitioner. 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. . .
.''
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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 penthiopyrad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with penthiopyrad 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 rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking 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
penthiopyrad, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to penthiopyrad and established a
tolerance 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 penthiopyrad, see Unit III.A. of the June 6, 2019,
rulemaking (84 FR 26352) (FRL-9994-08).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
penthiopyrad used for human risk assessment, see Unit III.B. of the
June 6, 2019, rulemaking.
Exposure assessment. Much of the exposure assessment remains the
same although updates have occurred to accommodate exposures from the
petitioned-for tolerance. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, please reference Unit III.C. of the June
6, 2019, rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new use of penthiopyrad on banana and were
conducted with Dietary Exposure Evaluation Model software using the
Food Commodity Intake Database (DEEM-FCID) Version 4.02, which uses the
2005-2010 food consumption data from the United States Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). The assessment used the
same assumptions as the June 6, 2019, final rule concerning tolerance-
level residues, default processing factors for all processed
commodities and 100 percent crop treated.
Drinking water exposure. The drinking water numbers have not
changed since the June 6, 2019, rulemaking.
Non-occupational exposure. There are no new residential (non-
occupational) exposures associated with the new proposed use. The
assessment of exposures to the currently registered uses on residential
sites (e.g., lawns and turf) has not changed since the June 6, 2019,
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 penthiopyrad and any other substances and
penthiopyrad does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that penthiopyrad has a common mechanism of toxicity with
other substances.
Safety factor for infants and children. EPA continues to conclude
that there are 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 June 6, 2019, 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 the chronic population adjusted dose (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 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 21% of the aPAD for all infants (less than 1 year
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 38% of the cPAD for all infants (less than 1 year
old), the population subgroup with the highest exposure estimate.
The combined short-term food, water, and residential exposures
result in aggregate MOEs of 440 in adults and 220 for children 1 to <2
years old. Because EPA's level of concern for penthiopyrad is an MOE of
100 or below, these MOEs are not of concern. For more details, refer to
unit III.E in the June 6, 2019, rulemaking and unit III.B of the April
7, 2021, rulemaking (86 FR 17917) (FRL-10017-27). As explained in unit
III.E. in the June 6, 2019, rulemaking, EPA has concluded that the
cancer risk is not of concern. Based on the risk assessments and
information described above, EPA concludes there is reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to penthiopyrad residues.
More detailed information can be found at https://www.regulations.gov
in the document titled ``Penthiopyrad. Human Health Risk Assessment for
the Proposed Registrations on Bananas and Greenhouse-Grown Lettuce'' in
docket ID number EPA-HQ-OPP-2021-0658.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the June 6, 2019, rulemaking.
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 has not established an MRL for residues of penthiopyrad
in or on banana.
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C. Revisions to Petitioned-For Tolerances
EPA is establishing the tolerance for residues of penthiopyrad in
or on bananas at 3 ppm instead of the petitioner-proposed 2 ppm. The 2
ppm value is likely the result of the Day 0 residues input into the
Organization for Economic Cooperation and Development (OECD) tolerance
calculator. However, in the residue decline trial, the residue on Day 0
(0.98 ppm) increased on Day 1 (1.11 ppm) before declining for the
remainder of the study. As the Day 1 harvest is allowable according to
the proposed application pattern, it is EPA's practice to use that
value instead of the Day 0 value. This input results in a tolerance of
3 ppm according to the OECD tolerance calculation procedures.
V. Conclusion
Therefore, a tolerance is established for residues of penthiopyrad,
including its metabolites and degradates, in or on banana at 3 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or to 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
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: February 14, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA amends 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. 180.658, amend table 1 to paragraph (a)(1) by adding, in
alphabetical order, an entry for ``Banana'' to read as follows:
Sec. 180.658 Penthiopyrad; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Banana..................................................... 3
* * * * *
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* * * * *
[FR Doc. 2023-03399 Filed 2-16-23; 8:45 am]
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