
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Rules and Regulations]
[Pages 38844-38846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17336]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0286; FRL-9964-40]


Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
prothioconazole in or on Sunflower subgroup 20B at 0.2 parts per 
million (ppm). Bayer CropScience requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 16, 2017. Objections and 
requests for hearings must be received on or before October 16, 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-2016-0286, 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, P.E., 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: RDFRNotices@epa.gov.

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-2016-0286 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 16, 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-2016-0286, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announced the filing of a pesticide petition (PP 
6E8469) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. This petition requested that 40 CFR 
180.626 be amended by establishing tolerances for residues of 
prothioconazole in or on imported commodities in the sunflower subgroup 
20B at 0.2 ppm. This document referenced a summary of a petition 
prepared by Bayer CropScience, the registrant, which are available in 
the docket, http://www.regulations.gov. No comments were received in 
response to the notice of filing.

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

[[Page 38845]]

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 prothiconazole including exposure resulting from 
the tolerance established by this action.

A. Risk Assessment

    In the Federal Register of November 10, 2016 (81 FR 78917) (FRL-
9953-71), EPA established tolerances for residues of prothioconazole in 
or on cotton, gin byproducts at 4.0 ppm and the cottonseed subgroup 20C 
at 0.4 ppm. Because much of the safety assessment of prothioconazole 
for the current action remains the same, EPA is relying in part upon 
the findings made in the November 10, 2016 final rule in support of 
this action.
    A summary of the toxicological profile and endpoints used for human 
risk assessment is discussed in Units III.A. and III.B of the November 
10, 2016 final rule.
    In evaluating dietary exposure for this action, EPA considered 
exposure under the petitioned-for tolerances as well as all existing 
prothioconazole tolerances in 40 CFR 180.626. The residue data used for 
the acute and chronic dietary exposure assessments have not changed 
since the assessment supporting the November 10, 2016 final rule, 
except to incorporate the recommended tolerance on commodities 
associated with Sunflower subgroup 20B, for which the Agency assumed 
tolerance-level residues and 100 percent crop treated. For a summary of 
how EPA assessed these dietary exposures, see Unit III.C.1 of the 
November 10, 2016 final rule.
    In addition, because the requested sunflower subgroup tolerance is 
not accompanied by a corresponding request for a U.S. registration for 
use of prothioconazole on the commodities in the sunflower subgroup, 
the drinking water and residential exposure assessments remain the 
same. A summary of EPA's assessment of drinking water exposure and 
residential exposure is discussed in Units III.C.2. and III.C.3.
    A summary of EPA's conclusions about the cumulative effects of 
prothioconazole can be found in Unit III.C.4. of the November 10, 2016 
final rule; however, since the November 10, 2016 final rule was 
published, the Agency has updated its dietary exposure and risk 
analysis for the common triazole metabolites 1,2,4-triazole (T), 
triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic 
acid (TP). The update was completed in association with registration 
requests for several triazole fungicides and includes, inter alia, the 
potential exposure to the common triazole metabolites resulting from 
the use of prothioconazole on commodities in the sunflower subgroup 
20B. That analysis concluded that risk estimates were below the 
Agency's level of concern for all population groups. This assessment 
may be found on http://www.regulations.gov by searching for the 
following title and docket number: ``Common Triazole Metabolites: 
Updated Dietary (Food + Water) Exposure and Risk Assessment to Address 
the New Section 3 Registrations For Use of Difenoconazole on Rice and 
Cotton.'' (located in docket ID number EPA-HQ-OPP-2016-0254).
    Because there have been no changes to the potential for prenatal 
and postnatal toxicity or in the completeness of data with respect to 
toxicity and exposure, EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
additional tenfold (10x) margin of safety required under section 
408(b)(2)(C) (``FQPA safety factor'') were reduced to 1x. A summary of 
EPA's rationale for this determination is discussed in Unit III.D. of 
the November 10, 2016 final rule.

B. 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-term 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 exists.
    Using the exposure assumptions discussed above and in the November 
10, 2016 final rule, EPA assessed acute and chronic dietary exposure 
from food and drinking water and concluded that the new tolerances on 
sunflower subgroup 20B do not change the risk estimates from the 
November 10, 2016 final rule. The acute dietary exposure utilized 40% 
of the aPAD for females 13-49 years old at the 95th percentile. The 
chronic dietary exposure utilized 32% of the cPAD for the U.S. 
population, and 77% for all infants (<1 year), the most highly exposed 
population subgroup.
    Because there are no existing or proposed residential uses for 
prothioconazole, there are no exposures expected via the residential 
exposure pathway. Therefore, all aggregate risk estimates are expected 
to be equivalent to dietary (food and drinking water) risk estimates 
mentioned above.
    Therefore, 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 prothioconazole residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer both to the 
November 10, 2016 final rule and its supporting documents, available at 
http://www.regulations.gov in docket ID number EPA-HQ-OPP-2015-0722, 
and to the risk assessment for this current action ``Prothioconazole: 
Human Health Risk Assessment for the Petition for a Tolerance Without 
U.S. Registration for Residues in/on sunflower subgroup 20B.'' in 
docket ID number EPA-HQ-OPP-2016-0286.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography with tandem mass spectrometry (LC/
MS/MS) methods are available for enforcing prothioconazole tolerances 
in crop and livestock commodities. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-350; telephone number: (410) 305-2905; 
email address: residuemethods@epa.gov.

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.
    There is currently a Codex MRL for sunflower/safflower established 
at 0.05 ppm. The U.S. EPA is establishing a tolerance on sunflower at 
0.2 ppm to harmonize with a major trading partner, Canada, in order to 
have a harmonized North America MRL for the Sunflower subgroup 20B. A 
tolerance cannot be established at the lower Codex MRL

[[Page 38846]]

because it would present a trade irritant for sunflower commodities 
coming into the United States.

V. Conclusion

    Therefore, a tolerance is established for residues of 
prothioconazole, in or on sunflower subgroup 20B at 0.2 parts 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: July 26, 2017.
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.  180.626, add alphabetically the entry ``Sunflower subgroup 
20B'' to the table in paragraph (a)(1), and add footnote 1 to the table 
to read as follows:


Sec.  180.626  Prothioconazole; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sunflower subgroup 20B \1\..................................         0.2
 
                                * * * * *
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\1\ There are no U.S. registrations allowing use of prothioconazole on
  the commodities in the Sunflower subgroup 20B as of August 16, 2017.

* * * * *
[FR Doc. 2017-17336 Filed 8-15-17; 8:45 am]
 BILLING CODE 6560-50-P


