[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

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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)
------------------------------------------------------------------------
                                                              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]
BILLING CODE 6560-50-P