[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Rules and Regulations]
[Pages 46156-46159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17682]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0118; FRL-8653-01-OCSPP]


Fluensulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerance for residues of 
fluensulfone in or on soybean, seed. Makhteshim Agan of North America 
(d/b/a ADAMA) requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 18, 2021. Objections and 
requests for hearings must be received on or before October 18, 2021, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2020-0118, 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 concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

[[Page 46157]]

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-2020-0118 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 
October 18, 2021. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2020-0118, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP 
9F8799) by Makhteshim Agan of North America (d/b/a ADAMA), 3120 
Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested 
that 40 CFR 180.680 be amended by establishing tolerances for residues 
of the nematicide fluensulfone, in or on soybean, seed at 0.1 parts per 
million (ppm); soybean, forage at 7.0 ppm; and soybean, hay at 20 ppm. 
That document referenced a summary of the petition prepared by 
Makhteshim Agan of North America, the petitioner, which is available in 
the docket, http://www.regulations.gov. Two comments were received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing a tolerance that varies from what is requested. The reason 
for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified 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 tolerance established by this action. EPA's assessment of exposures 
and risks associated with fluensulfone follows.
    In an effort to streamline Federal Register publications, EPA is 
not reprinting here summaries of its analyses that have previously 
appeared in the Federal Register in previous tolerance rulemakings for 
the same pesticide. To that end, this rulemaking refers the reader to 
several sections from the April 13, 2018 tolerance rulemaking for 
residues of fluensulfone that remain unchanged for an understanding of 
the Agency's rationale in support of this rulemaking. See 83 FR 15971 
(FRL-9975-76). Those sections are: Units III.A (Toxicological Profile); 
III.B. (Toxicological Points of Departure/Levels of Concern); and 
III.C. (Exposure Assessment), except as explained in the next 
paragraphs; III.D. (Safety Factor for Infants and Children).
    Exposure assessment updates. EPA's exposure assessments have been 
updated to include the additional exposure from use of fluensulfone on 
soybeans. EPA's aggregate exposure assessment incorporated this 
additional dietary exposure, as well as exposure from drinking water 
and from residential sources. The new use does not result in an 
increase in the estimated residue levels in drinking water or in 
exposure from residential sources relative to those used in the last 
assessment.
    Further information about EPA's risk assessment and determination 
of safety supporting the new fluensulfone tolerance can be found at 
http://www.regulations.gov in the document titled ``Fluensulfone. Human 
Health Risk Assessment for a New Use on Soybean.'' in docket ID EPA-HQ-
OPP-2020-0118.
    Assessment of aggregate risks. 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-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the appropriate points of 
departure (PODs) 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: The 
acute dietary risk estimate is 21% of the aPAD for infants (<1 year 
old), the group with the highest exposure. Chronic dietary risks are 
below the Agency's level of concern: 4.8% of the cPAD for infants (<1 
year old), the group with the highest

[[Page 46158]]

exposure. EPA has concluded the combined short-term food, water, and 
residential exposures result in aggregate margins of exposure above the 
level of concern of 100 for all scenarios assessed and are not of 
concern. EPA has determined that quantification of cancer risk using a 
non-linear approach (i.e., reference dose) will adequately account for 
all chronic toxicity, including carcinogenicity, that could result from 
exposure to fluensulfone; the chronic aggregate assessment did not 
result in risk estimates of concern.
    Determination of safety. 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 to establish a tolerance on 
soybean can be found in the document entitled, ``Fluensulfone. Human 
Health Risk Assessment for a new use on Soybean'' by going to the 
docket established by this action, which is described under ADDRESSES.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate residue analytical methods for enforcing 
tolerances for fluensulfone residues of concern in/on the registered 
plant and livestock commodities. These methods include two high-
performance liquid chromatography methods with tandem mass-spectroscopy 
detection (HPLC/MS/MS) for determining residues in/on plant and 
livestock matrices.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., 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). 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 Codex has not established a MRL for fluensulfone on soybean.

C. Response to Comments

    EPA received two comments from anonymous sources. One comment cited 
concern regarding fluoride; this comment is not relevant to the 
Agency's evaluation of a tolerance for the proposed new use of 
fluensulfone on soybean. The other comment expresses concern about 
pesticides in general, and requests that the Agency deny use of 
fluensulfone without specifically mentioning the new use on soybean. 
While the agency recognizes that some people do not like pesticides, 
the Agency has evaluated the aggregate risk of fluensulfone and has 
determined that 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.

D. Revisions to Petitioned-For Tolerances

    The agency has determined that tolerances are not needed for 
soybean, forage and soybean, hay, as the label contains a feeding 
restriction for those commodities, and the commodities will not be in 
the channels of trade. Further, the agency has recommended amending the 
proposed tolerance for soybean, seed from 0.1 ppm to 0.07 ppm based 
upon the OECD MRL/Tolerance Calculation Procedures.

V. Conclusion

    Therefore, a tolerance is established for residues of fluensulfone 
on soybean, seed at 0.07 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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.


[[Page 46159]]


    Dated: August 6, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.680, amend the table 1 to Sec.  180.680 by adding in 
alphabetical order in paragraph (a) the entry ``Soybean, seed'' to read 
as follows:


Sec.  180.680  Fluensulfone; tolerances for residues.

    (a) * * *

                        Table 1 to Sec.   180.680
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Soybean, seed.............................................          0.07
 
                              * * * * * * *
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[FR Doc. 2021-17682 Filed 8-17-21; 8:45 am]
BILLING CODE 6560-50-P