[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Rules and Regulations]
[Pages 8704-8707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02516]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0066 and EPA-HQ-OPP-2019-0586; FRL-10017-32]
Benzovindiflupyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
benzovindiflupyr in or on lowbush blueberries, ginseng, and sugar beet
roots, leaves, and dried pulp. Interregional Research Project Number 4
(IR-4) and Syngenta Crop Protection requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 9, 2021. Objections and
requests for hearings must be received on or before April 12, 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2020-0066 and EPA-HQ-OPP-2019-
0586, are 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:
[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 Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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 numbers EPA-HQ-OPP-2020-0066 and EPA-HQ-OPP-2019-0586 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 April 12, 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 numbers EPA-HQ-OPP-2020-0066 and EPA-
HQ-OPP-2019-0586, 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 8705]]
dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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
9E8806) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of benzovindiflupyr (N-[9-
(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-
(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide) in or on the raw
agricultural commodities Blueberry, lowbush at 2 parts per million
(ppm) and Ginseng at 0.3 ppm. That document referenced a summary of the
petition prepared by Syngenta, the registrant, which is available in
the docket EPA-HQ-OPP-2020-0066, http://www.regulations.gov. There were
no comments received in response to the notice of filing.
In the Federal Register of February 4, 2020 (85 FR 6129) (FRL-
10003-17), 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
9F8772) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC, 27419. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of benzovindiflupyr in or on the
raw agricultural commodities Beet, sugar, dried pulp at 0.15 ppm; Beet,
sugar, roots at 0.08 ppm; and Beet, sugar, tops at 0.06 ppm. That
document referenced a summary of the petition prepared by Syngenta, the
registrant, which is available in the docket EPA-HQ-OPP-2019-0586,
http://www.regulations.gov. One relevant comment was received in
response to the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA is
establishing several tolerances at different levels than were
petitioned for and is also modifying a commodity definition. The reason
for these changes is explained in Unit IV.D.
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 benzovindiflupyr including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
benzovindiflupyr 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. 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
benzovindiflupyr, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to benzovindiflupyr 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 benzovindiflupyr, see Unit III.A. of the June 22, 2018
rulemaking (83 FR 29033) (FRL-9977-94).
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 October 2, 2015 rulemaking
(80 FR 59627) (FRL-9933-03).
Exposure Assessment. Much of the exposure assessment remains the
same, although some updates have occurred to accommodate exposures from
the petitioned-for tolerances and reflect changes to the non-dietary,
non-occupational exposure assessment. The updates are discussed in this
section; for a description of the rest of the EPA approach to and
assumptions for the exposure assessment, see Unit III.C. of the June
22, 2018 rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of benzovindiflupyr on lowbush
blueberry, ginseng, and sugar beet. The assessment used the same
assumptions concerning 100 percent crop treated and tolerance-level
residues as the June 22, 2018 final rule. Drinking water exposures are
not impacted by the new uses, and thus have not changed since the last
assessment.
There have been two updates to the residential exposure assessment
since the June 22, 2018 final rule. The updated assessment no longer
assesses risks to residential handlers, since the label requirements
for handlers to wear specific clothing and to use personal protective
equipment (PPE) are presumed to indicate that these products are not
intended for homeowner use; thus, there is no residential handler
exposure. The consideration of the new turf use does not change
previous conclusions about post-application risk exposures.
EPA's conclusions concerning cumulative risk remain unchanged from
the June 22, 2018 rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude
that there is reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the
June 22, 2018 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
dietary 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
[[Page 8706]]
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.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD: They are 44% of the aPAD for children 1 to 2 years old,
the population subgroup with the highest exposure estimate. Chronic
dietary risks are below the Agency's level of concern of 100% of the
cPAD: They are 19% of the cPAD for children 1 to 2 years old, the
population subgroup with the highest exposure estimate. Because the
chronic dietary risks are below EPA's level of concern, EPA also
concludes that benzovindiflupyr will not pose a cancer risk. The short-
term aggregate MOE (food, water, and residential) is 500 for children 1
to 2 years old. This MOE exceeds the target level of concern of 100, so
it is not of concern. There are no intermediate or long-term
residential exposures.
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 benzovindiflupyr residues. More detailed
information about the Agency's analysis can be found at http://www.regulations.gov in the documents titled ``Benzovindiflupyr. Human
Health Risk Assessment for the Proposed New Food Use on Lowbush
Blueberries and Ginseng and New Non-Food Uses.'' in docket ID number
EPA-HQ-OPP-2020-0066 and ``Benzovindiflupyr. Human Health Risk
Assessment for the Proposed New Use on Sugar Beets'' in docket ID
number EPA-HQ-OPP-2019-0586.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the June 22, 2018 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).
There are no benzovindiflupyr Codex MRLs established for
blueberries, ginseng, or sugar beets.
C. Response to Comments
Although three comments were submitted to the docket in response to
the February 4, 2020 Notice of Filing, only one specifically related to
this tolerance action. The commenter requested that EPA deny Syngenta's
request for tolerances for benzovindiflupyr on sugar beets out of a
concern for the general health impacts of pesticides.
Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by section 408 of the FFDCA authorizes EPA to
establish tolerances when it determines that the tolerance is safe.
Upon consideration of the validity, completeness, and reliability of
the available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that the benzovindiflupyr tolerances are
safe. The commenter has provided no information indicating that a
safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances
Based on available residue data and using the Organization for
Economic Cooperation and Development (OECD) calculator, EPA has
determined that it is appropriate to set the tolerance level for beet,
sugar, dried pulp at 0.6 ppm rather than as proposed at 0.15 ppm. Also,
the tolerance is being established on ``Beet, sugar, leaves'' rather
than ``Beet, sugar, tops'' to be consistent with Agency nomenclature;
this tolerance is being established at 0.07 ppm rather than 0.06 ppm.
V. Conclusion
Therefore, tolerances are established for residues of
benzovindiflupyr in or on beet, sugar, dried pulp at 0.6 ppm; beet
sugar, leaves at 0.07 ppm; beet, sugar, roots at 0.08 ppm; blueberry,
lowbush at 2 ppm; and ginseng at 0.3 ppm.
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 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 tolerances and
modifications 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
[[Page 8707]]
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 30, 2020.
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:
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. 180.686, amend paragraph (a) by designating the table as
Table 1 to Paragraph (a) and adding, in alphabetical order, to newly
designated Table 1 the entries ``Beet, sugar, dried pulp''; ``Beet,
sugar, leaves''; ``Beet, sugar, roots''; ``Blueberry, lowbush''; and
``Ginseng'' to read as follows:
Sec. 180.686 Benzovindiflupyr; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
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Parts per
Commodity million
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* * * * *
Beet, sugar, dried pulp.................................... 0.6
Beet, sugar, leaves........................................ 0.07
Beet, sugar, roots......................................... 0.08
Blueberry, lowbush......................................... 2
* * * * *
Ginseng.................................................... 0.3
* * * * *
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* * * * *
[FR Doc. 2021-02516 Filed 2-8-21; 8:45 am]
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