[Federal Register Volume 87, Number 97 (Thursday, May 19, 2022)]
[Rules and Regulations]
[Pages 30425-30429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10785]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0013; FRL-9738-01-OCSPP]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of the
insecticide flonicamid, including its metabolites and degradates, in or
on small fruit vine climbing (except fuzzy kiwifruit), subgroup 13-07F
at 3 parts per million (ppm). In addition, this regulation amends the
existing tolerance for residues of flonicamid, including its
metabolites and degradates, in or on alfalfa, hay, by increasing the
current tolerance from 1.0 ppm to 7 ppm. ISK Biosciences Corporation
requested tolerances for these commodities under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 19, 2022. Objections and
requests for hearings must be received on or before July 18, 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-2016-0013, 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. 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.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit 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 Avenue NW,
Washington, DC 20460; 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
[[Page 30426]]
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-2016-0013 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
July 18, 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-2016-0013, 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.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
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 June 28, 2021 (86 FR 33926) (FRL-10025-
08), 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
0F8884) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, OH 44077. The petition requests to establish a tolerance in 40
CFR part 180 for residues of the insecticide flonicamid, including its
metabolites and degradates, determined by measuring the sum of
flonicamid (N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide)
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid, in or on small fruit vine climbing (except
fuzzy kiwifruit), subgroup 13-07F at 3.0 parts per million (ppm). In
addition, this regulation amends the existing tolerance for residues of
the insecticide flonicamid in or on alfalfa, hay, by increasing the
current tolerance from 1.0 ppm to 7.0 ppm. That document referenced a
summary of the petition prepared by ISK Biosciences Corporation, the
registrant, which is available in docket ID number EPA-HQ-OPP-2016-
0013, https://www.regulations.gov. No public comments were received in
response to the notice of filing.
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 tolerances that vary from what the petitioners sought.
The reasons for these changes are explained in full detail in Unit
IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the insecticide flonicamid in or on small fruit
vine climbing (except fuzzy kiwifruit), subgroup 13-07F and the
increased tolerance on alfalfa, hay.
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 several tolerance rulemakings for
flonicamid, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to flonicamid and established tolerances for
residues of that chemical. In December 2020, EPA also finalized the
``Flonicamid Interim Registration Decision'' (go to https://www.regulations.gov/ and search for docket ID number EPA-HQ-OPP-2014-
0777). EPA is incorporating previously published sections from those
rulemakings and any updates to the toxicological data base for
flonicamid provided as part of the Flonicamid Interim Registration
Decision in this tolerance rulemaking.
Toxicological profile. For a discussion of the Toxicological
Profile for flonicamid used for human risk assessment, see the
Flonicamid Interim Registration Decision by going to docket
[[Page 30427]]
ID number EPA-HQ-OPP-2014-0777 at https://www.regulations.gov.
Toxicological points of departure/Levels of concern. EPA has
reevaluated the toxicological database for the Flonicamid Interim
Registration Decision. The table of the Toxicological points of
departure/Levels of concern for flonicamid in the risk assessment
included an endpoint for incidental oral exposures. However, the Agency
has made the assumption in the current risk assessment that the new use
of flonicamid and the increased tolerance on alfalfa, hay were not
likely to result in incidental oral exposures, as young children are
not expected in the areas where applications occur. An additional
difference in the current risk assessment is that the inhalation point
of departure was based on an oral study. Since no inhalation data are
available, toxicity by the inhalation route of exposure is considered
to be equivalent to the estimated toxicity by the oral route of
exposure. For a full summary of the Toxicological points of departure/
Levels of concern for flonicamid used for human risk assessment, see
``Flonicamid: Human Health Draft Risk Assessment for Registration
Review'' by going to docket ID number EPA-HQ-OPP-2014-0777 at https://www.regulations.gov.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the new use of
flonicamid and the increased tolerance on alfalfa, hay. The assessment
used the same assumptions as the July 23, 2018 rulemaking final rule
concerning tolerance-level residues, default processing factors for all
processed commodities, and 100 percent crop treated, see Unit III.C. of
the July 23, 2018 rulemaking (83 FR 34775) (FRL-9977-82). For a more
detailed description related to these updates, see ``Flonicamid:
Establishment of Permanent Tolerances in/on Small Vine-Climbing Fruit,
except Fuzzy Kiwifruit (Subgroup 13-07F) and an Increased Tolerance on
Alfalfa. Summary of Analytical Chemistry and Residue Data'' by going to
docket ID number EPA-HQ-OPP-2016-0013 at https://www.regulations.gov.
Drinking water exposure. The new use of flonicamid in or on small
fruit vine climbing (except fuzzy kiwifruit), subgroup 13-07F and
increased residue levels for alfalfa, hay do not result in an increase
in the estimated residue levels in drinking water, so EPA used the same
estimated drinking water concentrations (EDWCs) in the chronic dietary
assessment as identified in the July 23, 2018, rulemaking and in the
Flonicamid Interim Registration Decision.
Non-Occupational exposure. Residential handler and post-application
exposures are not expected from the new use of flonicamid and the
increased tolerance on alfalfa, hay. However, there are pending uses on
roses, flowers, shrubs, and small (non-fruit bearing) trees that would
result in residential handler as well as post-application exposures
that were recently assessed. All registered flonicamid product labels
with residential use sites require that handlers wear specific clothing
(e.g., long-sleeved shirt/long pants) and/or use personal protective
equipment (PPE). Therefore, the Agency has made the assumption that
these products are not for homeowner use and has not conducted a
quantitative residential handler assessment. A quantitative residential
post-application assessment was also not conducted as incidental oral
exposures are not anticipated and there is no dermal exposure endpoint.
Therefore, no residential exposures are applicable for the aggregate
risk assessment.
Cumulative exposures. 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.'' EPA's assessment
of cumulative exposures has not changed since the July 23, 2018,
rulemaking (83 FR 34775) (FRL-9977-82).
Safety factor for infants and children. The scientific information
underpinning EPA's prior safety factor determination remains unchanged
from the July 23, 2018, rulemaking (83 FR 34775) (FRL-9977-82).
Therefore, EPA continues to conclude that there is reliable data to
support the reduction of the Food Quality Protection Act (FQPA) safety
factor for flonicamid. See Unit III.D. of the July 23, 2018, rulemaking
(83 FR 34775) (FRL-9977-82) for a discussion of the Agency's rationale
for that determination.
C. 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 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.
Acute risk. An acute aggregate dietary risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral dose was
identified and no acute dietary endpoint was selected. Therefore,
flonicamid is not expected to pose an acute risk.
Short-term and Intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Flonicamid is not
registered for any use patterns that would result in short- and
intermediate-term residential exposures. The estimated aggregate MOE
for adult handlers is 1,100 (LOC=100) and is not of concern. Risk
estimates for children are expected to be equivalent to the dietary
exposure and risk assessment.
Chronic risk. Chronic dietary (food + water) risk to flonicamid was
below the EPA's LOC (<100% cPAD) for the general U.S. population. The
chronic dietary (food + drinking water) exposure were estimated at 29%
of the cPAD for the general U.S. population and 91% cPAD for children 1
to 2 years old (the most highly exposed population subgroup) and are
below EPA's LOC (<100% cPAD).
Aggregate cancer risk for U.S. population. Flonicamid has been
determined to have suggestive evidence of carcinogenicity, but not
sufficient to assess human carcinogenic potential. The Agency has
determined that quantification of risk using a non-linear approach
(i.e., using a chronic reference dose) adequately accounts for all
chronic toxicity, including carcinogenicity that could result from
exposure to flonicamid. Therefore, the chronic reference dose is
considered protective for carcinogenic effects. As a result, a separate
cancer risk assessment was not conducted, and the chronic dietary
exposure is considered protective of any cancer dietary risks.
Based on the risk assessments and information described above, EPA
concludes there is a reasonable certainty that no harm will result to
the general U.S. population, or to infants and children, from aggregate
exposure to flonicamid residues. More detailed information on the
subject action to establish tolerances in or on small fruit, vine
climbing (except fuzzy kiwifruit), subgroup 13-07F and to increase the
[[Page 30428]]
existing tolerance in or on alfalfa, hay can be seen in the documents
``Flonicamid: Petition for the Establishment of Permanent Tolerances
in/on Small Vine-Climbing Fruit, except Fuzzy Kiwifruit (Subgroup 13-
07F) and a Tolerance Increase on Alfalfa. Summary of Analytical
Chemistry and Residue Data and Flonicamid (128016); Chronic Aggregate
Dietary (Food and Drinking Water) Exposure and Risk Assessment for the
Petition for the Establishment of Permanent Tolerances in/on Small
Vine-climbing Fruit, except Fuzzy Kiwifruit (Subgroup 13-07F) and a
Tolerance Increase on Alfalfa'' by going to docket ID number EPA-HQ-
OPP-2016-0013 at https://www.regulations.gov.
IV. Other Considerations
A. Analytical Enforcement Methodology
Analytical methodology has been developed to determine the residues
of flonicamid and its three major plant metabolites, TFNA, TFNG, and
TFNA-AM in various crops. The residue analytical method for the
majority of crops includes an initial extraction with acetonitrile
(ACN)/deionized (DI) water, followed by a liquid-liquid partition with
ethyl acetate. The residue method for wheat straw is similar, except
that a C18 solid phase extraction (SPE) is added prior to the liquid-
liquid partition. The final sample solution is quantitated using a
liquid chromatograph (LC) equipped with a reverse phase column and a
triple quadruple mass spectrometer (MS/MS).
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
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 tolerance expression for plant and livestock commodities are
harmonized between the U.S. and Canada, but not Codex. There are no
Codex MRLs established on small fruit vine climbing (except fuzzy
kiwifruit), subgroup 13-07F or alfalfa. Thus, harmonization is not an
issue with Codex. There are no Canada MRLs established on small fruit
vine climbing (except fuzzy kiwifruit), subgroup 13-07F. Canada has a
default MRL of 0.1 ppm established in/on alfalfa. Therefore,
tolerances/MRLs are not harmonized between the U.S. and Canada for
alfalfa.
C. Revisions to Petitioned-For Tolerances
The petitioned-for tolerances for small fruit vine climbing (except
fuzzy kiwifruit), subgroup 13-07F are different from those being
established by EPA. These differences are attributable to the
petitioned-for levels not being consistent with Organization for
Economic Cooperation and Development (OECD) rounding class practice.
V. Conclusion
A tolerance is therefore established for residues of the
insecticide flonicamid, including its metabolites and degradates, in or
on small fruit vine climbing (except fuzzy kiwifruit), subgroup 13-07F
at 3 ppm. In addition, this tolerance rulemaking amends the existing
tolerance for residues of the insecticide flonicamid in or on alfalfa,
hay at 7 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). 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: May 16, 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 I as follows:
[[Page 30429]]
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. Section 180.613(a)(1) is amended in the table by:
0
a. Adding a table heading;
0
b. Revising the entry for ``Alfalfa, hay''; and
0
c. Adding the commodity ``Small fruit vine climbing (except fuzzy
kiwifruit), subgroup 13-07F'' in alphabetical order.
The additions and revision read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
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Parts per
Commodity million
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* * * * *
Alfalfa, hay............................................... 7
* * * * *
Small fruit vine climbing (except fuzzy kiwifruit), 3
subgroup 13-07F...........................................
* * * * *
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* * * * *
[FR Doc. 2022-10785 Filed 5-18-22; 8:45 am]
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