[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Rules and Regulations]
[Pages 68915-68918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26397]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0603; FRL-9234-01-OCSPP]


Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
cyflumetofen in or on hop, dried cones. The Interregional Project 
Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 6, 2021. Objections and 
requests for hearings must be received on or before February 4, 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-2020-0603, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health emergency, the EPA Docket Center (EPA/DC) 
and Reading Room is closed to visitors with limited exceptions. The 
staff continues to provide customer service via email, phone, and 
webform. For the latest status information on EPA/DC services,

[[Page 68916]]

docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
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: 
[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, 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-2020-0603 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 
February 4, 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-2020-0603, 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 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 February 25, 2021 (86 FR 11488) (FRL-
10020-47), 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 
0E8862) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 
40 CFR 180.677 be amended by establishing a tolerance for the residue 
of the of the miticide cyflumetofen, 2-methoxyethyl [alpha]-cyano-
[alpha]-[4-(1,1-dimethylethyl)phenyl]-[beta]-oxo-2-
(trifluoromethyl)benzenepropanoate in or on hop, dried cones at 30 
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.

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 cyflumetofen including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with cyflumetofen 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 
cyflumetofen, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to cyflumetofen 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 cyflumetofen, see Unit III.A. of the May 8, 2019 rulemaking 
(84 FR 20037) (FRL-9990-60).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
cyflumetofen used

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for human risk assessment, see Unit III.B. of the May 8, 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 May 8, 
2019 rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new use of cyflumetofen on hops. The 
assessment used the same assumptions as the May 8, 2019 final rule 
concerning tolerance-level residues, default processing factors for all 
processed commodities, and 100 percent crop treated.
    Drinking water exposure. EPA has revised the cyflumetofen drinking 
water assessment since the May 8, 2019 final rule. Based on the 
Pesticide in Water Calculator's (PWC) version 1.52, the estimated 
drinking water concentration (EDWC) of cyflumetofen in surface water is 
estimated to be 0.18 ppb for non-cancer chronic exposures. The EDWC of 
0.18 ppb was used in the chronic dietary assessment.
    Non-occupational exposure. There are no new proposed residential 
(non-occupational) uses for cyflumetofen at this time; however, there 
are registered uses of cyflumetofen on commercial vegetable gardens and 
ornamental plants. EPA's residential exposure assessment has changed 
since the May 8, 2019 final rule based on a revised practice. Because 
all current cyflumetofen labels require handlers to wear personal 
protective equipment, EPA assumes that cyflumetofen is applied by 
professional applicators, not residential (homeowner) applicators. 
Therefore, the current assessment does not consider exposure to 
residential handlers or exposure from direct homeowner applications to 
ornamentals or home gardens. EPA assumes that potential dermal exposure 
from consumers handling ornamentals or vegetable transplants is 
negligible. Additionally, there is no toxicity endpoint for dermal 
exposure, so a quantitative residential post-application dermal risk 
assessment is not required. Therefore, the aggregate exposure 
assessment no longer includes residential handler or residential post-
application exposures.
    Cumulative exposures. 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 
cyflumetofen and any other substances and cyflumetofen does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has not assumed that 
cyflumetofen 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. See Unit III.D. of the May 
8, 2019 final rule for a discussion of the Agency's rationale for that 
determination.
    Aggregate risk 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 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.
    An acute dietary risk was not conducted as toxicological effects 
attributable to a single dose were not identified. Chronic dietary 
risks are below the Agency's level of concern of 100% of the cPAD; they 
are less than 3% for children 1-2 years old, the population subgroup 
with the highest exposure estimate.
    Because EPA has determined that there are no residential exposures, 
the chronic dietary risk is the same as the overall aggregate risk for 
cyflumetofen and is not of concern. As stated in Unit III.A. of the May 
8, 2019 final rule, EPA concluded that the nonlinear approach for 
assessing potential cancer risk is appropriate. The chronic risk 
resulting from aggregate exposure to cyflumetofen is below the Agency's 
level of concern; therefore, the Agency concludes that there is not a 
cancer risk of concern from exposure to cyflumetofen.
    Therefore, based on the risk assessments and information described 
above, EPA concludes that there is reasonable certainty that no harm 
will result in the general population, or to infants and children, from 
aggregate exposure to cyflumetofen residues. More detailed information 
can be found at https://www.regulations.gov in the document titled 
``Cyflumetofen. Human Health Risk Assessment for the Section 3 
Registration Action for a New Use on Hops.'' in docket ID number EPA-
HQ-OPP-2020-0603.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the July 1, 2020 rulemaking (85 FR 39491) (FRL-10009-
25).

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 MRLs for residues of 
cyflumetofen in/on hops.

V. Conclusion

    Therefore, a tolerance is established for residues of cyflumetofen, 
2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate in or on hop, dried 
cones at 30 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 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

[[Page 68918]]

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: November 24, 2021.
Catherine Aubee,
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:

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.  180.677, amend the table in paragraph (a) by adding a table 
heading and adding in alphabetical order an entry for ``Hop, dried 
cones'' to read as follows:


Sec.  180.677  Cyflumetofen; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones.......................................              30
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2021-26397 Filed 12-3-21; 8:45 am]
BILLING CODE 6560-50-P