[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 [www.gpo.gov]
[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 
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. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

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: 
[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/current/title-40.

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:
     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/where-send-comments-epa-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 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, https://www.regulations.gov. 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


