[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
[[Page 68917]]
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
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* * * * *
Hop, dried cones....................................... 30
* * * * *
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* * * * *
[FR Doc. 2021-26397 Filed 12-3-21; 8:45 am]
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