[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Rules and Regulations]
[Pages 44942-44945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20747]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0049; FRL-9966-68]


Oxathiapiprolin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 44943]]

SUMMARY: This regulation establishes a tolerance for residues of the 
fungicide oxathiapiprolin in or on cacao bean, dried bean. 
Interregional Research Project Number 4 (IR-4) requested the tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 27, 2017. Objections and 
requests for hearings must be received on or before November 27, 2017, 
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-2016-0049, 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 L. Goodis, 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 
Printing 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-2016-0049 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 27, 2017. 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-2016-0049, 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 Tuesday, December 20, 2016 (81 FR 92758) 
(FRL-9956-04), 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# 6E8505) by Interregional Research Project Number 4 (IR-
4). The petition requested that 40 CFR 180.685 be amended by 
establishing tolerances for residues of the fungicide oxathiapiprolin, 
1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-
1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
ethanone, in or on cacao bean, bean at 0.10 parts per million (ppm); 
cacao bean, roasted bean at 0.15 ppm; cacao bean, chocolate at 0.15 
ppm; and cacao bean, cocoa powder at 0.15 ppm. A summary of the 
petition prepared by IR-4 is available in the docket, http://www.regulations.gov. There were no comments received on the notice of 
filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that differ from what the petitioner requested 
including; the commodity definition, tolerance level, and for which 
commodities. 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 reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has

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sufficient data to assess the hazards of and to make a determination on 
aggregate exposure for oxathiapiprolin including exposure resulting 
from the tolerance established by this action, consistent with FFDCA 
section 408(b)(2).
    In the Federal Register of Monday, December 5, 2016 (81 FR 87463) 
(FRL-9954-69), EPA established tolerances for residues of 
oxathiapiprolin in or on several food commodities. The risk assessments 
supporting that action aggregated dietary and non-occupational 
exposures from existing and proposed uses of oxathiapiprolin, including 
from the exposures associated with the tolerances requested in this 
action. That assessment, which included the tolerances in today's 
action, concluded that the tolerances are safe; therefore, EPA is 
incorporating the findings in that Federal Register document and the 
supporting risk assessments as the basis for the safety finding in this 
tolerance rulemaking. In brief, the Agency determined that the lack of 
toxicity of oxathiapiprolin warranted a qualitative risk assessment, 
without the need for the additional Food Quality Protection Act safety 
factor to protect infants and children.
    Specific information on the studies received and the nature of the 
adverse effects caused by oxathiapiprolin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, ``Oxathiapiprolin--New Active 
Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, 
and a Number of Crops'' dated June 25, 2015, in docket ID number EPA-
HQ-OPP-2016-0049-0018. In addition, an abbreviated human health risk 
assessment document was developed to support the proposed uses of 
oxathiapiprolin on multiple crops, including cacao. That document, 
``SUBJECT: Oxathiapiprolin. Human Health Risk Assessment to Support the 
Registration of New Uses of the Fungicide on Various Crops'' dated 
October 31, 2016 is available in docket ID number EPA-HQ-OPP-2016-0049-
0017.
    In conclusion, based on the findings of the December 5, 2016 
Federal Register document and the supporting documents, 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 oxathiapiprolin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method 30422 (Supplement No. 1) was developed for plant 
commodities, and Method 31138 was developed for livestock commodities. 
Residues of oxathiapiprolin and associated metabolites are extracted 
from crop or livestock commodity samples using a solution of formic 
acid, water and acetonitrile, and diluted with acetonitrile and water. 
Both methods use liquid chromotography with tandem mass spectrometry 
(LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and 
detection by electrospray tandem mass spectrometry (MS/MS).
    The FDA multi-residue methods are not suitable for detection and 
enforcement of oxathiapiprolin residues or associated metabolites. 
However, the European Multiresidue Method (DFG Method S19) and the 
QuEChERS Multiresidue Method have shown success in some matrices.
    Adequate enforcement methodology (LC/MS/MS) is available to enforce 
the tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch/BEAD/OPP, Environmental Science Center, 701 
Mapes Rd., Ft. George G. 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 maximum residue limits (MRLs) for 
oxathiapiprolin.

C. Revisions to Petitioned-For Tolerances

    A tolerance is established for ``Cacao bean, dried bean'', rather 
than ``Cacao bean, bean'', to comply with current Agency crop-naming 
policy. Also, EPA determined that tolerances for residues of 
oxathiapiprolin in or on the processed commodities of cacao bean, 
roasted bean; cacao bean, chocolate; and cacao bean, cocoa powder are 
unnecessary because these commodities are covered by cacao bean, dried 
bean tolerance. Finally, the tolerance for cacao bean, dried bean is 
being established at 0.15 ppm, rather than at 0.1 ppm as requested, 
based on the available residue data.

V. Conclusion

    Therefore, a tolerance is established for residues of the fungicide 
oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on cacao bean, dried 
bean at 0.15 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

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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: August 29, 2017.
Michael L. 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.  180.685, redesignate paragraph (a)(1) as paragraph (a) and 
add alphabetically the following commodity ``Cacao bean, dried bean'' 
to the table in paragraph (a) in alphabetical order to read as follows:


Sec.  180.685  Oxathiapiprolin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cacao bean, dried bean......................................        0.15
 
                                * * * * *
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[FR Doc. 2017-20747 Filed 9-26-17; 8:45 am]
 BILLING CODE 6560-50-P