Rule2022-14224
Pyriofenone; 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 5, 2022
Effective
July 5, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of pyriofenone in or on the tomato subgroup 8-10A and the pepper/eggplant subgroup 8-10B and removes the established tolerance for the vegetable, fruiting, group 8-10 and the expired tolerance for the fruit, small vine climbing subgroup 13-07D. 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 87 Issue 127 (Tuesday, July 5, 2022)</title>
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[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Rules and Regulations]
[Pages 39752-39756]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14224]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0386; FRL-9819-01-OCSPP]
Pyriofenone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
pyriofenone in or on the tomato subgroup 8-10A and the pepper/eggplant
subgroup 8-10B and removes the established tolerance for the vegetable,
fruiting, group 8-10 and the expired tolerance for the fruit, small
vine climbing subgroup 13-07D. Interregional Research Project Number 4
[[Page 39753]]
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July 5, 2022. Objections and
requests for hearings must be received on or before September 6, 2022,
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-2021-0386, is 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. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting 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#98cadcdecad6f7ecf1fbfdebd8fde8f9b6fff7ee"><span class="__cf_email__" data-cfemail="88dacccedac6e7fce1ebedfbc8edf8e9a6efe7fe">[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>.
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 number EPA-HQ-OPP-2021-0386 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
September 6, 2022. 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-2021-0386, 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/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-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 October 21, 2021 (86 FR 58239) (FRL-
8792-04-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 1E8905) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The October
21, 2021, document incorrectly identified the petition number as
1E9805. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide pyriofenone in or
on the pepper/eggplant subgroup 8-10B at 2 parts per million (ppm) and
the tomato subgroup 8-10A at 0.3 ppm. The petition also requested to
remove the existing tolerance on vegetable, fruiting, group 8-10 at 0.3
ppm. That document referenced a summary of the petition, which is
available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. One comment was
submitted by the United States Department of Agriculture (USDA) in
response to the notice of filing. The comment was in support of the
petition.
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 tolerances at different levels than petitioned for
and is modifying the crop group definition to be consistent with Agency
terminology. A discussion of these modifications can be found in
section 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 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 pyriofenone
[[Page 39754]]
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
pyriofenone 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 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 tolerance rulemakings for pyriofenone
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to pyriofenone and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of pyriofenone, see Unit III.A. of the May 30, 2019, rulemaking
(84 FR 24983) (FRL-9993-11).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
pyriofenone used for human risk assessment, please reference Unit
III.B. of the May 30, 2019, rulemaking.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the new greenhouse uses
of pyriofenone on the pepper/eggplant subgroup and tomato subgroup. An
acute dietary exposure assessment was not performed as there are no
appropriate toxicological effects attributable to a single exposure
(dose). A conservative chronic dietary exposure assessment was
performed for pyriofenone, assuming 100 percent crop treated (PCT),
tolerance-level residues, and default processing factors. The chronic
dietary exposure assessment was revised to reflect the updated Dietary
Exposure Evaluation Model that incorporates the What We Eat in America
(WWEIA) consumption data from 2005-2010. The chronic estimated drinking
water concentration (EDWC) of 3.9 ppb is unchanged from the May 30,
2019, rulemaking and was directly incorporated into the chronic
assessment. A cancer dietary assessment was not conducted because
pyriofenone is classified as ``not likely to be carcinogenic to
humans.'' Because there are no existing or proposed residential uses
associated with pyriofenone, there is not expected to be any
residential handler exposure or post-application exposures.
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 pyriofenone and any other substances and
pyriofenone does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that pyriofenone 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 May 30, 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
aggregate 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 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.
An acute dietary exposure assessment was not performed as there
were no appropriate toxicological effects attributable to a single
exposure (dose) observed in available oral toxicity studies, including
maternal toxicity in the developmental toxicity studies. Chronic
dietary risks are below the Agency's level of concern of 100% of the
cPAD; they are 4.9% of the cPAD for children 1 to 2 years old, the
group with the highest exposure. There are no proposed or registered
residential uses; therefore short- and intermediate-term residential
exposure is not expected. Pyriofenone is classified as ``Not Likely to
Be Carcinogenic to Humans''; therefore, EPA does not expect pyriofenone
exposures to pose an aggregate cancer risk.
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 pyriofenone residues. More detailed information
on this action can be found in the document titled ``Pyriofenone. Human
Health Risk Assessment for Section 3 Registration of Pyriofenone in
Greenhouses for Crop Groups 8-10 and 9'' in docket ID EPA-HQ-OPP-2021-
0386.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the May 30, 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).
Codex has not established MRLs on crop subgroups 8-10A (tomato
subgroup) or 8-10B (pepper/eggplant subgroup).
C. Revisions to Petitioned-For Tolerances
The Organisation for Economic Co-operation and Development (OECD)
maximum residue limit (MRL) Calculation Procedures of the tomato
residue data result in a tolerance of 0.2 ppm; EPA is thus establishing
a tolerance of 0.2 ppm for tomato subgroup 8-10A instead of the
petitioned-for level of 0.3 ppm. The correct crop subgroup name for 8-
10B is pepper/eggplant subgroup 8-10B, not pepper/eggplant 8-10B. As a
housekeeping measure, EPA is removing the tolerance for fruit, small
vine climbing subgroup 13-07D, which expired on October 6, 2021.
D. International Trade Considerations
In this rule, EPA is establishing a tolerance for pyriofenone
residues in or on the tomato subgroup 8-10A at 0.2 ppm that is lower
than the current tolerance of vegetable, fruiting, group 8-
[[Page 39755]]
10 (0.3 ppm). For the reasons explained in the Pyriofenone Human Health
Risk Assessment, the Agency believes these revised, lower tolerances
are appropriate based on available residue data.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of the changes to these tolerances in order to satisfy its
obligations under the Agreement. In addition, the SPS Agreement
requires that Members provide a ``reasonable interval'' between the
publication of a regulation subject to the Agreement and its entry into
force to allow time for producers in exporting Member countries to
adapt to the new requirement. Accordingly, EPA is retaining the
existing tolerances for the commodities in tomato subgroup 8-10A by
establishing an expiration date for the tomato subgroup 8-10A at the
existing tolerance level of 0.3 ppm to allow this tolerance to remain
in effect for a period of six months after the effective date of this
final rule. (Although crop group 8-10 also includes a subgroup 8-10C
for which EPA is not setting separate tolerances, all of the
commodities in subgroup 8-10C are also included in subgroup 8-10B, for
which EPA is establishing a higher tolerance at 2 ppm; therefore, there
is no need to retain a separate tolerance for subgroup 8-10C.) After
the six-month period expires, the allowable residues on members of the
tomato subgroup 8-10A must conform to the new lower tolerance level of
0.2 ppm. This reduction in tolerance level is not discriminatory; the
same food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.
V. Conclusion
Therefore, tolerances are established for residues of pyriofenone
in or on the pepper/eggplant subgroup 8-10B at 2 ppm and the tomato
subgroup 8-10A at 0.2 ppm. Additionally, the existing tolerance for the
vegetable, fruiting, group 8-10 is removed but the tolerance for tomato
subgroup 8-10A at the existing level of 0.3 ppm is designated to expire
6 months from the publication of this document. Finally, EPA is
removing the tolerance for fruit, small vine climbing subgroup 13-07D
that expired on October 6, 2021, which completes the implementation of
the pyriofenone tolerance changes in the April 15, 2021 rulemaking (86
FR 17545) (FRL-10019-55). The tolerance for fruit, small vine climbing
subgroup 13-07D is no longer needed because, in 2021, EPA established
separate tolerances for residues of pyriofenone in/on grape; grape,
raisin; and fruit, small vine climbing, except grape, subgroup 13-07E.
Subgroup 13-07E includes all the commodities in subgroup 13-07D other
than grape.
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 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 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: June 22, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. 180.660, amend the table in paragraph (a) by:
0
a. Removing the entry for ``Fruit, small vine climbing subgroup 13-
07D\1\''.
0
b. Adding in alphabetical order entries for ``Pepper/eggplant subgroup
8-10B''; ``Tomato subgroup 8-10A''; and ``Tomato subgroup 8-10A\1\''.
0
c. Removing the entry for ``Vegetable, fruiting, group 8-10''; and
0
d. Revising the footnote.
The additions and revision read as follows:
[[Page 39756]]
Sec. 180.660 Pyriofenone; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
* * * * *
Pepper/eggplant subgroup 8-10B................................ 2
Tomato subgroup 8-10A......................................... 0.2
Tomato subgroup 8-10A \1\..................................... 0.3
* * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on January 5, 2023.
* * * * *
[FR Doc. 2022-14224 Filed 7-1-22; 8:45 am]
BILLING CODE 6560-50-P
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