[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Rules and Regulations]
[Pages 60178-60182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23628]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0601; FRL-9111-01-OCSPP]
Fluensulfone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes and removes tolerances for
residues of fluensulfone in or on multiple crops that are identified
later in this document. The Interregional Research Project Number 4
(IR-4) requested these tolerance actions under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 1, 2021. Objections and
requests for hearings must be received
[[Page 60179]]
on or before January 3, 2022, and must be filed in accordance with the
instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0601, is 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 emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide customer service via email, phone, and
webform. For the latest status information on EPA/DC services, docket
access, visit http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the 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(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-2020-0601 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
January 3, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0601, 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/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 28, 2021 (86 FR 33922) (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
0E8861) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.680 be amended by establishing tolerances for
residues of the sum of fluensulfone, 5-chloro-2-[(3,4,4- trifluoro-3-
buten-1-yl)sulfonyl]thiazole and its metabolite, 3,4,4-trifluoro-but-3-
ene-1-sulfonic acid, calculated as the stoichiometric equivalent of
fluensulfone, in or on the commodities: Beet, sugar, dried pulp at 0.3
parts per million (ppm); Beet, sugar, leaves at 4 ppm; Beet, sugar,
molasses at 1.5 ppm; Beet, sugar, roots at 0.2 ppm; Brassica, leafy
greens, subgroup 4-16B at 20 ppm; Celtuce at 4 ppm; Fennel, Florence,
fresh leaves and stalk at 4 ppm; Kohlrabi at 1.5 ppm; Leafy greens
subgroup 4-16A at 4 ppm; Leaf petiole vegetable subgroup 22B at 4 ppm;
and Vegetable, Brassica, head and stem, group 5-16 at 1.5 ppm. The
petition also requested to remove established tolerances for residues
of the sum of fluensulfone, 5-chloro-2-[(3,4,4- trifluoro-3-buten-1-
yl)sulfonyl]thiazole and its metabolite, 3,4,4-trifluoro-but-3- ene-1-
sulfonic acid, calculated as the stoichiometric equivalent of
fluensulfone, in or on the following commodities: Brassica, head and
stem, subgroup 5A at 1.5 ppm; Brassica, leafy greens, subgroup 5B at 20
ppm; and Vegetables, leafy, except Brassica, group 4 at 4 ppm because
these commodities would be covered by the new tolerances established
for the crop group conversions above. That document referenced a
summary of the petition prepared by IR-4, the petitioner, which is
available in the docket, http://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 is
establishing one tolerance at a different level than petitioned for. A
discussion of this revision to the petitioned-for tolerance can be
found in section IV.C. In addition, IR-4 initially petitioned for
tolerances for multiple sugar beet commodities but withdrew their
request for these tolerances and the new use on sugar beet on April 8,
2021. EPA is therefore not establishing tolerances for the sugar beet
commodities.
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
[[Page 60180]]
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 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 fluensulfone including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with fluensulfone 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 rulemaking, and 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
fluensulfone, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to fluensulfone and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings that remain
unchanged as described further in this rulemaking.
Toxicological profile. For a discussion of the Toxicological
Profile of fluensulfone, see Unit III.A. of the fluensulfone tolerance
rulemaking published in the Federal Register of April 13, 2018 (83 FR
15971) (FRL-9975-76).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
fluensulfone used for human risk assessment, see Unit III.B. of the
fluensulfone tolerance rulemaking published in the Federal Register of
June 1, 2016 (81 FR 34896) (FRL-9946-07).
Exposure assessment. This action converts existing crop group
tolerances for Brassica, head and stem, subgroup 5A; Brassica, leafy
greens, subgroup 5B; and Vegetables, leafy, except Brassica, group 4,
which were established in the fluensulfone tolerance rulemaking
published in the Federal Register of May 24, 2019 (84 FR 24042) (FRL-
9992-69), to new tolerances for Brassica, leafy greens, subgroup 4-16B;
Celtuce; Fennel, Florence, fresh leaves and stalk; Kohlrabi; Leaf
petiole vegetable subgroup 22B; Leafy greens subgroup 4-16A; and
Vegetable, Brassica, head and stem, group 5-16. Although tolerance
levels for some commodities have changed as a result of these crop
group conversions, they have not impacted the residue estimates or
Estimated Drinking Water Concentrations (EDWCs) used in the dietary
exposure assessment for the May 24, 2019 rulemaking for these
commodities. Therefore, the dietary exposure assessment remains the
same. For a description of the rest of the EPA approach to and
assumptions for the exposure assessment, including with respect to
dietary exposure, residential exposure, and cumulative effects, see
Unit III.C. of the May 24, 2019 rulemaking.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the May
24, 2019 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 population adjusted dose
(aPAD) and chronic population adjusted dose (cPAD). Short-,
intermediate-, and chronic 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 dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 21% of the aPAD for infants (<1 year old), the
group with the highest estimated exposure. Chronic dietary risks are
below the Agency's level of concern of 100% of the cPAD; they are 4.8%
of the cPAD for infants (<1 year old), the group with the highest
estimated exposure. EPA concluded that the combined food, water, and
residential exposures result in aggregate MOEs above the level of
concern of 100 for all relevant exposure scenarios and are not of
concern. As the chronic dietary endpoint and dose are protective of
potential cancer effects, fluensulfone is not expected to pose a
dietary or aggregate cancer risk of concern.
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 fluensulfone residues. More detailed information
on this action can be found in the document entitled, ``Fluensulfone.
Petition for Crop Group Conversions to Brassica Head and Stem Vegetable
Group 5-16, Brassica Leafy Greens Subgroup 4-16B, Leafy Greens Subgroup
4-16A, Leaf Petiole Vegetable Subgroup 22B, Kohlrabi, Celtuce, and
Florence Fennel'' by going to the docket established by this action,
which is described under ADDRESSES.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the May 24, 2019 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). EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The tolerance for crop subgroup 4-16B (20 ppm) is harmonized with
the Codex MRLs for mizuna and mustard greens; all other Codex MRLs for
crops within crop subgroup 4-16B are lower than 20 ppm. The tolerance
for kohlrabi (1.5 ppm) is harmonized with the Codex MRL for kohlrabi.
The tolerance for crop subgroup 4-16A (4 ppm) is harmonized with the
Codex MRL for spinach; all other Codex MRLs for commodities within crop
subgroup 4-16A are lower than 4 ppm. The tolerance for crop
[[Page 60181]]
subgroup 22B (2 ppm) is harmonized with the Codex MRL for celery. The
tolerance for crop group 5-16 (1.5 ppm) is harmonized with all Codex
commodities within the crop group except Chinese cabbage, napa, which
has a Codex MRL of 1 ppm. There are no Codex MRLs for Florence fennel
and celtuce.
C. Revisions to Petitioned-For Tolerances
The petitioner proposed a tolerance value of 4 ppm for leaf petiole
vegetable subgroup 22B based on the existing tolerance for vegetables,
leafy, except Brassica, crop group 4. Instead, EPA is establishing a
tolerance value of 2 ppm for crop subgroup 22B to harmonize with the
Codex MRL for celery. EPA analyzed the existing celery data, which
supports a tolerance of 2 ppm according to the Organization for
Economic Cooperation and Development (OECD) tolerance calculation
procedure.
D. International Trade Considerations
In this rule, EPA is establishing tolerances for fluensulfone
residues in or on the leaf petiole vegetable subgroup 22B at 2 ppm,
which is lower than the existing tolerance in or on vegetables, leafy,
except Brassica, group 4, which includes cardoon; celery; celery,
Chinese; and rhubarb (all at 4 ppm and all part of the leaf petiole
vegetable subgroup 22B). The Agency believes this revised, lower
tolerance is appropriate because it is harmonized with the Codex MRL
for celery and is supported by available residue data.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of the changes to these tolerances in order to satisfy its
obligations under the Agreement. In addition, the SPS Agreement
requires that Members provide a ``reasonable interval'' between the
publication of a regulation subject to the Agreement and its entry into
force to allow time for producers in exporting Member countries to
adapt to the new requirement. Accordingly, EPA is establishing an
expiration date for the existing tolerance for residues of fluensulfone
in or on vegetables, leafy, except Brassica, group 4 to allow it to
remain in effect for a period of six months after the effective date of
this final rule. After the six-month period ends, this tolerance will
expire, as indicated in the regulatory text, and allowable residues on
cardoon; celery; celery, Chinese; and rhubarb must conform to the new
tolerance for leaf petiole vegetable subgroup 22B. This reduction in
the tolerance level is not discriminatory; the same food safety
standard contained in the FFDCA applies equally to domestically
produced and imported foods. The new tolerance level is supported by
available residue data.
V. Conclusion
Therefore, tolerances are established for residues of fluensulfone
in or on Brassica, leafy greens, subgroup 4-16B at 20 ppm; Celtuce at 4
ppm; Fennel, Florence, fresh leaves and stalk at 4 ppm; Kohlrabi at 1.5
ppm; Leaf petiole vegetable subgroup 22B at 2 ppm; Leafy greens
subgroup 4-16A at 4 ppm; and Vegetable, Brassica, head and stem, group
5-16 at 1.5 ppm.
Additionally, the following existing tolerances are unnecessary due
to the establishment of the above tolerances: Brassica, head and stem,
subgroup 5A; Brassica, leafy greens, subgroup 5B; and Vegetables,
leafy, except Brassica, group 4. Therefore, existing tolerances for
residues of fluensulfone in or on Brassica, head and stem, subgroup 5A
and Brassica, leafy greens, subgroup 5B are removed, and to satisfy
international trade obligations, the existing tolerance for residues of
fluensulfone in or on Vegetables, leafy, except Brassica, group 4
expires six months after the effective date of this final rule.
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 to 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 tolerances 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.
[[Page 60182]]
Dated: October 22, 2021.
Catherine Aubee,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. 180.680, amend table 1 to Sec. 180.680 following paragraph
(a) by:
0
a. Adding in alphanumerical order to the table entries for ``Brassica,
leafy greens, subgroup 4-16B''; ``Celtuce''; ``Fennel, Florence, fresh
leaves and stalk''; ``Kohlrabi''; ``Leaf petiole vegetable subgroup
22B''; ``Leafy greens subgroup 4-16A''; and ``Vegetable, Brassica, head
and stem, group 5-16'';
0
b. Removing the entries for ``Brassica, head and stem, subgroup 5A'';
and ``Brassica, leafy greens, subgroup 5B''; and
0
c. Revising the entry for ``Vegetables, leafy, except Brassica, group
4''.
The additions read as follows:
Sec. 180.680 Fluensulfone; tolerances for residues.
(a) * * *
Table 1 to Sec. 180.680
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Parts per
Commodity million
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* * * * *
Brassica, leafy greens, subgroup 4-16B..................... 20
Celtuce.................................................... 4
Fennel, Florence, fresh leaves and stalk................... 4
* * * * *
Kohlrabi................................................... 1.5
Leaf petiole vegetable subgroup 22B........................ 2
Leafy greens subgroup 4-16A................................ 4
* * * * *
Vegetable, Brassica, head and stem, group 5-16............. 1.5
* * * * *
Vegetables, leafy, except Brassica, group 4\1\............. 4
* * * * *
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\1\ This tolerance expires on May 2, 2022.
* * * * *
[FR Doc. 2021-23628 Filed 10-29-21; 8:45 am]
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