[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Rules and Regulations]
[Pages 17545-17548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06271]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0335; FRL-10019-55]


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 fruit, small vine climbing subgroup 13-07E, except 
grape; grape and grape, raisin. ISK BIOSCIENCES Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective April 5, 2021. Objections and 
requests for hearings must be received on or before May 5, 2021, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2020-0335, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

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 Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2020-0335 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 
June 4, 2021. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2020-0335, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about

[[Page 17546]]

dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 5, 2020 (85 FR 47330) (FRL-10012-
32), 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 
9F8808) by ISK BIOSCIENCES Corporation, 7470 Auburn Road, Suite A, 
Concord, OH, 44077. The petition requested that 40 CFR 180.660 be 
amended by establishing tolerances for residues of the fungicide, 
pyriofenone, (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-
trimethoxy-6-methylphenyl) methanone, in or on fruit, small vine 
climbing subgroup 13-07E, except grape at 1.5 parts per million (ppm); 
grape at 0.8 ppm; and grape, raisin at 2.5 ppm. In addition, although 
not mentioned in EPA's document, ISK's petition also requested that the 
currently established tolerances for residues of pyriofenone in/on 
fruit, small vine climbing subgroup 13-07D at 1.5 ppm be removed from 
40 CFR 180.660, as establishment of the requested tolerances for 
subgroup 13-07E and grape include all the crops in subgroup 13-07D. 
That document referenced a summary of the petition prepared by ISK 
BIOSCIENCES Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. No comment was received in response 
to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for pyriofenone 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 rulemakings of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings, and republishing the same sections is 
unnecessary; therefore, 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 
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 those 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 used for the 
safety assessment, see Unit III.B. of the May 30, 2019 rulemaking.
    Exposure Assessment. EPA's exposure assessment remains unchanged 
from what was done in support of the May 30, 2019 rulemaking. EPA's 
aggregate exposure assessments include exposures from food, drinking 
water and residential sources, and there have been no changes since the 
last assessment. For a discussion of EPA's assessment of aggregate 
exposures, see Unit III.C. of the May 30, 2019 rulemaking.
    Safety Factor for Infants and Children. EPA continues to conclude 
that there is reliable data showing that the safety of infants and 
children would be adequately protected if the FQPA SF were reduced from 
10X to 1X for all exposure scenarios. The reasons for that decision are 
articulated in Unit III.D. of the May 30, 2019 rulemaking.
    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 PAD (aPAD) and chronic PAD 
(cPAD). Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists. For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure.
    Pyriofenone is not expected to pose an acute risk, due to the lack 
of acute adverse effects in the database. Chronic dietary risks are 
below the Agency's level of concern: 6.9% of the chronic population 
adjusted dose (cPAD) for children 1 to 2 years old, the group with the 
highest exposure. There are no residential uses for pyriofenone; 
therefore, the chronic aggregate risk is limited to the chronic dietary 
risk and is not of concern. Short- and intermediate-term aggregate 
risks are addressed by the chronic aggregate risk estimates and are not 
a concern.
    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 populations, or to infants and children for 
aggregate exposure to pyriofenone residues. More detailed information 
on the subject action can be found at https://www.regulations.gov in 
the document entitled, ``Pyriofenone. Human Health Risk Assessment for 
the Section 3 Registration on Fruiting Vegetables (Crop Group 8-10)'' 
in the docket ID number EPA-HQ-OPP-2020-0335 and the document titled, 
``Pyriofenone. Human Health Risk Assessment for the Section 3 
Registration on Fruiting Vegetables (Crop Group 8-10)'' in docket ID 
number EPA-HQ-OPP-2018-0677.

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

[[Page 17547]]

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 Alimentarius is a joint 
United Nations Food and Agriculture Organization/World Health 
Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain the reasons for departing from the 
Codex level.
    The Codex has established MRLs for pyriofenone in or on grape at 
0.8 ppm and grape, raisin at 2.5 ppm. The U.S. tolerances for these 
commodities are harmonized with these MRLs.

C. Revisions to Petitioned-For Tolerances

    Under FFDCA section 408(d)(4)(A)(i), EPA may establish tolerances 
that vary from those sought by the petition. The tolerance level has 
been modified to be consistent with the Agency's rounding class 
practices.

D. International Trade Considerations

    In this Final Rule, EPA is establishing an individual tolerance for 
grape at 0.8 ppm, which is lower than the current allowed amount of 
residue on grape, by virtue of its inclusion in the small vine climbing 
fruit subgroup 13-07D at 1.5 ppm. The Agency is reducing this tolerance 
to harmonize with the Codex MRL on grape, and available residue data 
demonstrate that this tolerance is sufficient to cover residues on this 
commodity.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of this revision. 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. To accommodate this reasonable interval, EPA is 
establishing an expiration date for the existing tolerance for small 
vine climbing fruit subgroup 13-07D to allow those tolerances to remain 
in effect for a period of 6 months after the effective date of this 
rule. At the end of that 6-month period, the existing tolerances for 
subgroup 13-07D will no longer be valid; residues on grape will need to 
comply with the new grape tolerance and residues on other commodities 
in that subgroup will need to comply with the new subgroup 13-07E 
tolerance.
    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 level is 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of pyriofenone, 
(5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-trimethoxy-6-
methylphenyl) methanone, in or on fruit, small vine climbing subgroup 
13-07E, except grape at 1.5 ppm; grape at 0.8 ppm; and grape, raisin at 
2.5 ppm. EPA is also establishing an expiration date for the existing 
tolerance for fruit, small vine climbing subgroup 13-07D.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies tolerances under FFDCA section 
408(d) in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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: March 8, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

[[Page 17548]]

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. Designating the table as Table 1;
0
b. Revising the entry for ``Fruit, small vine climbing, subgroup 13-
07D''; and
0
c. Adding in alphabetical order entries for ``Fruit, small vine 
climbing, subgroup 13-07E, except grape''; ``Grape''; and ``Grape, 
raisin''.
    The additions and revision read as follows:


Sec.  180.660   Pyriofenone; tolerances for residues.

* * * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, small vine climbing subgroup 13-07D \1\................       1.5
Fruit, small vine climbing subgroup 13-07E, except grape......       1.5
Grape.........................................................       0.8
Grape, raisin.................................................       2.5
 
                                * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on October 6, 2021.

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[FR Doc. 2021-06271 Filed 4-2-21; 8:45 am]
BILLING CODE 6560-50-P


