[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Rules and Regulations]
[Pages 59025-59027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21159]

[[Page 59025]]



40 CFR Part 180

[EPA-HQ-OPP-2021-0417; FRL-10088-01-OCSPP]

Benzovindiflupyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
benzovindiflupyr in or on Vegetable, root, except sugar beet, subgroup 
1B. Syngenta requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 29, 2022. Objections and 
requests for hearings must be received on or before November 28, 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-2021-0417, 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 and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].


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-2021-0417 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 
November 28, 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-2021-0417, 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 
     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 September 22, 2021 (86 FR 52624) (FRL-
8792-03-OCSPP), 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 1F8914) by Syngenta Crop Protection, LLC. The petition 
requested that 40 CFR 180.686 be amended by establishing tolerances for 
residues of the fungicide benzovindiflupyr, in or on vegetable, root, 
except sugar beet, subgroup 1B, and ginseng, at 0.6 parts per million 
(ppm). That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, LLC, the registrant, which is available in 
the docket ID number EPA-HQ-OPP-2021-0417 at https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified a commodity definition, established the tolerance at an 
increased level, and removed the existing ginseng tolerance. The 
reasons for these changes are explained in Unit IV.C.

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

[[Page 59026]]

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 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 
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 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 June 
22, 2018, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new use of benzovindiflupyr on the 
commodities in Vegetable, root, except sugar beet, subgroup1B. The 
assessments used the same assumptions considering 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; the 
estimated drinking water concentrations are the same as in the June 22, 
2018, final rule.
    The proposed new use will not result in residential exposure, 
although there are existing residential uses that were previously 
assessed. The revisions to the residential exposure and risk 
assessments in the June 22, 2018, final rule were described in the 
February 9, 2021, final rule (86 FR 8704) (FRL-10017-32) and have not 
changed since then.
    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.'' 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 
benzovindiflupyr and any other substances and benzovindiflupyr does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has not assumed 
that benzovindiflupyr has a common mechanism of toxicity with other 
    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 
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 
aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD 
(cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD: They are 16% of the aPAD for the general population and 
43% 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 6.1% of the 
cPAD for the general population and 20% of the cPAD for children 1 to 2 
years old, the population subgroup with the highest exposure estimate. 
Because the chronic dietary risks, which were quantified using a non-
linear (i.e., RfD) approach accounting for all chronic toxicity and any 
potential carcinogenic effects, are below EPA's level of concern, the 
Agency concludes that benzovindiflupyr will not pose a cancer risk. The 
short-term aggregate MOE (food, water, and residential) is 487 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 https://www.regulations.gov in the documents titled ``Benzovindiflupyr. Human 
Health Risk Assessment for the Proposed New Food Use on Vegetable Root, 
Subgroup 1B (except sugar beets)'' in docket ID number EPA-HQ-OPP-2021-

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). The Codex has not established an MRL for residues of 
benzovindiflupyr in or on Vegetable, root, except sugar beet, subgroup 

C. Revisions to Petitioned-For Tolerances

    FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a 
tolerance that varies from that sought by the petition. EPA is 
establishing the tolerance at 0.6 ppm for residues of benzovindiflupyr 
in or on Vegetable, root, except sugar beet,

[[Page 59027]]

subgroup 1B. The EPA determined a higher tolerance was required by 
calculating the recommended tolerance for carrot and radish data 
separately and using the highest recommended tolerance rather than 
calculating the recommended tolerance using the combined carrot and 
radish data as the registrant did. The Agency also revised the 
commodity definition to use standard terminology for the subgroup.
    Additionally, the petition requested that ginseng be excluded from 
the tolerance for subgroup 1B. However, rather than exclude ginseng 
from this tolerance to avoid duplicative tolerances, EPA is removing 
the established tolerance of 0.3 ppm for residues of benzovindiflupyr 
in or on ginseng because it is included in the crop subgroup covered by 
this tolerance.

V. Conclusion

    Therefore, a tolerance is established for residues of 
benzovindiflupyr, in or on vegetable, root, except sugar beet, subgroup 
1B at 0.6 ppm. In addition, EPA is removing the established tolerance 
for residues of benzovindiflupyr in or on 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). 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: September 22, 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:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.686, amend the table 1 to paragraph (a) by:
a. Removing the entry for ``Ginseng''; and
b. Adding in alphabetical order an entry ``Vegetable, root, except 
sugar beet, subgroup 1B''.
    The addition reads as follows:

Sec.  180.686   Benzovindiflupyr; tolerances for residues

* * * * *

                        Table 1 to Paragraph (a)
                                                             Parts per
                        Commodity                             million
                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B.........             0.6
                                * * * * *

* * * * *
[FR Doc. 2022-21159 Filed 9-28-22; 8:45 am]