[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57341-57343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23384]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0599; FRL-9998-88]


Sulfoxaflor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
sulfoxaflor in or on rice grain, rice hulls, and avocados. Dow 
AgroSciences LLC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 25, 2019. Objections and 
requests for hearings must be received on or before December 24, 2019, 
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-2018-0599, 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. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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, 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-2018-0599 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 
December 24, 2019. 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-2018-0599, 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 June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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 
4F8338) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 
46268. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of sulfoxaflor (1-(6-
trifluoromethylpyridin-3-yl)ethyl)(methyl)-oxido-l4-
sulfanylidenecyyanamide), in or on the following raw agricultural 
commodities: Rice, grain at 5 parts per million (ppm); rice, straw at 5 
ppm; rice, hulls at 14 ppm; and avocado, whole fruit at 0.15 ppm.
    One comment was received on the notice of filing. EPA's response to 
this comment is discussed in Unit IV.C.

[[Page 57342]]

    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what the petitioner requested, 
as authorized under FFDCA section 408(d)(4)(A)(i). EPA's explanation 
for those variations are contained 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 in FFDCA section 408(b)(2)(D), 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 sulfoxaflor in or on rice and 
avocado.
    On July 24, 2019, EPA published a final rule establishing a 
tolerance for residues of sulfoxaflor in or on multiple commodities 
based on the Agency's conclusion that those tolerances are safe for the 
general population, including infants and children (84 FR 35546) (FRL-
9995-63). EPA's exposure assessment supporting the July 24, 2019 final 
rule included exposure from use of sulfoxaflor on both avocado and rice 
commodities, but these tolerances were not established at the time 
because a Notice of Filing for the petition for these commodities was 
still pending and the statutory public comment period was still open. 
Because the toxicity profile of sulfoxaflor has not changed since that 
rule was published, and because residues of sulfoxaflor on both avocado 
and rice were included in the dietary exposure and risk assessment 
supporting that rule, EPA is incorporating the findings in the preamble 
to that July 24, 2019 final rule into this rulemaking.
    Further information about EPA's risk assessment and determination 
of safety supporting the tolerances established in the July 24, 2019 
Federal Register action, as well as the new sulfoxaflor tolerances on 
rice and avocado can be found at http://www.regulations.gov in the 
documents entitled: ``Sulfoxaflor. Human Health Risk Assessment for New 
Food Uses on Numerous Crops, Ornamentals Growing in Greenhouses and 
Nurseries and Tree Farms and Plantations'' and ``Sulfoxaflor. Human 
Health Risk Assessment for New Food Uses on Artichoke, Asparagus, 
Bushberry, Caneberry and Sunflower, and Multiple Crop Group 
Conversions.'' The documents may be found in docket ID numbers EPA-HQ-
OPP-2018-0599 and EPA-HQ-OPP-2018-0179.
    Therefore, based on the risk assessments and information described 
above, EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, or to infants and children from 
aggregate exposure to sulfoxaflor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    High performance liquid chromatographic methods with positive-ion 
electro spray interface (ESI) and tandem mass spectrometric detection 
(LC/MS/MS) were previously reviewed and found to be acceptable for 
tolerance enforcement of sulfoxaflor residues (the two metabolites, 
X11719474 and X11721061, are also quantitated). The limit of 
quantitation (LOQ), determined as the lowest level of method validation 
(LLMV), is 0.010 ppm in all 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). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. 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 sulfoxaflor in or on 
avocados or rice.

C. Response to Comments

    One comment was received that stated in part that tolerance levels 
should be zero because people do not need to be exposed to more poison. 
Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it 
determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that these sulfoxaflor tolerances are safe. The commenter has provided 
no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerance

    Although proposed by the petitioner, a tolerance is not being 
established on rice straw because the Agency no longer considers this 
commodity a significant livestock feed item, per the Chemistry Science 
Advisory Council (ChemSAC) memorandum on livestock feed (Revisions of 
Feedstuffs in Table 1 of OPPTS Test Guideline 860.1000 and Guidance on 
Constructing Maximum Reasonably Balanced Diets (MRBD); ChemSAC; 30 June 
2008). Also, based on results of the rice processing study, the Agency 
is establishing a tolerance of 15 ppm on rice hulls, rather than at 14 
ppm as requested. This is in accordance with the pertinent rounding 
class of the Organization for Economic Development and Cooperation 
(OECD) tolerance calculation procedure.

V. Conclusion

    Therefore, tolerances are established for residues of sulfoxaflor 
in or on avocado at 0.15 ppm; rice, grain at 5 ppm; and rice, hulls at 
15 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

[[Page 57343]]

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), nor is 
it considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). 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.

    Dated: September 30, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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.  180.668,
0
i. Add alphabetically entries for ``Avocado''; ``Rice, grain''; and 
``Rice, hulls'' to the table in paragraph (a) to read as follows:


Sec.  180.668   Sulfoxaflor; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
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                                * * * * *
Avocado.................................................            0.15
 
                                * * * * *
Rice, grain.............................................               5
Rice, hulls.............................................              15
 
                                * * * * *
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[FR Doc. 2019-23384 Filed 10-24-19; 8:45 am]
BILLING CODE 6560-50-P