82_FR_46878 82 FR 46685 - Florpyrauxifen-Benzyl; Pesticide Tolerances

82 FR 46685 - Florpyrauxifen-Benzyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 193 (October 6, 2017)

Page Range46685-46688
FR Document2017-21614

This regulation establishes tolerances for residues of florpyrauxifen-benzyl in or on rice grain, freshwater fish, shellfish crustacean, and mollusc. Dow AgroSciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 193 (Friday, October 6, 2017)
[Federal Register Volume 82, Number 193 (Friday, October 6, 2017)]
[Rules and Regulations]
[Pages 46685-46688]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21614]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0560; FRL-9963-66]


Florpyrauxifen-Benzyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
florpyrauxifen-benzyl in or on rice grain, freshwater fish, shellfish 
crustacean, and mollusc. Dow AgroSciences LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 6, 2017. Objections and 
requests for hearings must be received on or before December 5, 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-2016-0560, 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

[[Page 46686]]

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-2016-0560 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 5, 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-2016-0560, 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 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 
5F8403) 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 the herbicide florpyrauxifen-
benzyl (2-Pyridinecarboxylic acid, 4-amino-3-chloro-6-(4-chloro-2-
fluoro-3-methoxyphenyl)-5-fluoro-, phenylmethyl ester) and 
florpyrauxifen (metabolite; 2-Pyridinecarboxylic acid, 4-amino-3-
chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoro-), in or on the 
raw agricultural commodities rice, grain (dehulled) at 0.01 parts per 
million (ppm); rice, grain at 0.2 ppm; fish, freshwater at 2 ppm; 
shellfish, crustacean at 0.5 ppm; and shellfish, mollusk at 9 ppm. That 
document referenced a summary of the petition prepared by Dow 
AgroSciences LLC, the registrant, 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 tolerance levels that vary from the petitioned-for levels 
for certain crops and is correcting commodity definitions, as needed, 
to be consistent with current EPA policy. These changes are explained 
further 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 sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for florpyrauxifen-benzyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with florpyrauxifen-
benzyl follows.
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Florpyrauxifen-benzyl is not genotoxic and there were no treatment-
related findings up to the limit dose (1,000 milligrams/kilogram (mg/
kg)/day) or highest doses tested in the acute, short-term, sub-chronic, 
or chronic oral toxicity studies, two-generation

[[Page 46687]]

reproduction or developmental toxicity studies or in the neurotoxicity 
study. Chronic administration of florpyrauxifen-benzyl did not show any 
carcinogenicity potential and did not cause any adverse effects in 
mice, rats or dogs even up to the highest doses tested.
    Specific information on the studies received and the nature of the 
adverse effects caused by florpyrauxifen-benzyl 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 document ``Florpyrauxifen-benzyl: New Active 
Ingredient, First Food Use. Human Health Risk Assessment for the 
Establishment of Permanent Tolerances on Rice, Fish, and Shellfish and 
Registration for Uses on Rice and Freshwater Aquatic Weed Control'' 
dated December 1, 2016 in docket ID number EPA-HQ-OPP-2016-0560.
    Because no single or repeated dose study performed by any route of 
exposure produced an adverse effect following florpyrauxifen-benzyl 
exposure, toxicity endpoints and points of departure were not selected 
for florpyrauxifen-benzyl exposure scenarios and a quantitative risk 
assessment was not conducted. Instead, a qualitative human health risk 
assessment has been conducted to support the proposed uses of 
florpyrauxifen-benzyl.
    Florpyrauxifen-benzyl is proposed for use on rice and aquatic 
sites. Humans could potentially be exposed to florpyrauxifen-benzyl 
residues in food (including fish and shellfish) because florpyrauxifen-
benzyl may be applied directly to growing rice and aquatic sites. These 
applications can also result in florpyrauxifen-benzyl reaching surface 
and ground water, both of which can serve as sources of drinking water. 
There are no proposed uses in residential settings and there are no 
anticipated residential exposures.
    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure, 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA Safety Factor (SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor. EPA 
considers the toxicity database to be complete and there are no 
residual uncertainties in the florpyrauxifen-benzyl exposure database. 
Because there are no threshold effects in the florpyrauxifen-benzyl 
database, the requirement to retain this safety factor is inapplicable 
to the current tolerance action.
    Based on the lack of toxicity from exposure to residues of 
florpyrauxifen-benzyl, 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 florpyrauxifen-benzyl.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical enforcement methodology which uses high-
performance liquid chromatography with tandem mass spectrometry (HPLC/
MS-MS) to quantitate residues of florpyrauxifen-benzyl and 
florpyrauxifen is available for enforcement.
    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 florpyrauxifen-benzyl.

C. Revisions to Petitioned-For Tolerances

    Although a tolerance for rice, grain (dehulled) was requested, EPA 
determined that no such tolerance is required. Rice, grain (dehulled) 
is covered by the rice grain tolerance. Based on the Organization of 
Economic Cooperation and Development (OECD) statistical calculation 
applied to the field trial (U.S.) residue data, EPA determined that the 
appropriate tolerance level for rice, grain is 0.30 ppm. The OECD 
calculation procedures are globally recognized for calculating MRLs to 
facilitate the harmonization of regulatory limits.
    For fish-shellfish, mollusc the tolerance level is established at 
20 ppm, rather than the requested 9 ppm, based on the residue data. 
Also, to be consistent with current EPA policy, the commodity 
definitions were revised as fish-freshwater finfish; fish-shellfish, 
crustacean; and fish-shellfish, mollusc, and the Agency added a 
significant figure to the tolerances for rice, grain; fish-freshwater 
finfish; and fish-shellfish, crustacean.

V. Conclusion

    Despite the lack of toxicity, the EPA is establishing tolerances as 
requested by the petitioner for international trade purposes. 
Therefore, tolerances are established for residues of florpyrauxifen-
benzyl, including its metabolites and degradates, in or on rice, grain 
at 0.30 ppm; fish-freshwater finfish at 2.0 ppm; fish-shellfish, 
crustacean at 0.50 ppm; and fish-shellfish, mollusc at 20 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

[[Page 46688]]

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: September 8, 2017.
Richard P. Keigwin, Jr.,
Director, 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. Add Sec.  180.695 to subpart C to read as follows:


Sec.  [emsp14]180.695   Florpyrauxifen-benzyl; Pesticide Tolerances.

    (a) General. Tolerances are established for residues of 
florpyrauxifen-benzyl, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
florpyrauxifen-benzyl (phenylmethyl 4-amino-3-chloro- 6-(4-chloro-2-
fluoro-3-methoxyphenyl)-5-fluoro-2-pyridinecarboxylate) and its acid 
metabolite (4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5- 
fluoropyridine-2-carboxylic acid) calculated as the stoichiometric 
equivalent of florpyrauxifen-benzyl, in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Fish--freshwater finfish................................             2.0
Fish--shellfish, crustacean.............................            0.50
Fish--shellfish, mollusc................................              20
Rice, grain.............................................            0.30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2017-21614 Filed 10-5-17; 8:45 am]
BILLING CODE 6560-50-P



                                                                       Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations                                                      46685

                                                                                                   EPA-APPROVED FLORIDA REGULATIONS—Continued
                                                                                                                            State                               EPA
                                                      State citation                       Title/subject                   effective                          approval                          Explanation
                                                        (section)                                                            date                               date

                                                             *                        *                        *                          *                       *                      *                    *

                                                                                                       Chapter 62–296 Stationary Sources—Emission Standards

                                                  62–296.100 .............   Purpose and Scope ....................              10/6/08        10/6/17, [Insert Federal Register
                                                                                                                                                  citation].

                                                          *                          *                   *                             *                          *                      *                    *
                                                  62–296.405 .............   Fossil Fuel Steam Generators                         3/2/99        10/6/17, [Insert Federal Register
                                                                               with More Than 250 Million Btu                                     citation].
                                                                               Per Hour Heat Input.
                                                  62–296.406 .............   Fossil Fuel Steam Generators                         3/2/99        10/6/17, [Insert Federal Register
                                                                               with Less Than 250 Million Btu                                     citation].
                                                                               Per Hour Heat Input, New and
                                                                               Existing Emissions Units.

                                                          *                         *                        *                         *                          *                      *                    *
                                                  62–296.412 .............   Dry Cleaning Facilities ................            3/11/10        10/6/17, [Insert Federal Register
                                                                                                                                                  citation].
                                                  62–296.414 .............   Concrete Batching Plants ...........                1/10/07        10/6/17, [Insert Federal Register
                                                                                                                                                  citation].

                                                          *                        *                         *                         *                          *                      *                    *
                                                  62–296.418 .............   Bulk Gasoline Plants ...................            3/11/10        10/6/17, [Insert Federal Register
                                                                                                                                                  citation].

                                                          *                         *               *                                  *                          *                      *                    *
                                                  62–296.500 .............   Reasonably Available Control                        3/11/10        10/6/17, [Insert Federal Register
                                                                              Technology (RACT)—Volatile                                          citation].
                                                                              Organic Compounds (VOC)
                                                                              and Nitrogen Oxides (NOX)
                                                                               Emitting Facilities.

                                                          *                          *                    *                            *                          *                    *                   *
                                                  62–296.508 .............    Petroleum Liquid Storage ...........               10/6/08        10/6/17, [Insert Federal Register     Amendments effective 10/6/08
                                                                                                                                                  citation].

                                                             *                        *                        *                          *                       *                      *                    *

                                                                                                   Chapter 62–297 Stationary Sources—Emissions Monitoring

                                                  62–297.310 .............   General Emissions Test Require-                      3/9/15        10/6/17, [Insert Federal Register
                                                                              ments.                                                              citation].

                                                          *                        *                            *                      *                          *                      *                    *
                                                  62–297.450 .............   EPA VOC Capture               Efficiency             3/2/99        10/6/17, [Insert Federal Register
                                                                              Test Procedures.                                                    citation].

                                                             *                        *                        *                          *                       *                      *                    *



                                                  *      *       *       *      *                            ACTION:    Final rule.                                      178 (see also Unit I.C. of the
                                                  [FR Doc. 2017–21504 Filed 10–5–17; 8:45 am]                                                                            SUPPLEMENTARY INFORMATION).
                                                  BILLING CODE 6560–50–P                                     SUMMARY:   This regulation establishes                      ADDRESSES:   The docket for this action,
                                                                                                             tolerances for residues of                                  identified by docket identification (ID)
                                                                                                             florpyrauxifen-benzyl in or on rice                         number EPA–HQ–OPP–2016–0560, is
                                                  ENVIRONMENTAL PROTECTION                                   grain, freshwater fish, shellfish
                                                  AGENCY                                                                                                                 available at http://www.regulations.gov
                                                                                                             crustacean, and mollusc. Dow
                                                                                                                                                                         or at the Office of Pesticide Programs
                                                                                                             AgroSciences LLC requested these
                                                  40 CFR Part 180                                                                                                        Regulatory Public Docket (OPP Docket)
                                                                                                             tolerances under the Federal Food,
asabaliauskas on DSKBBXCHB2PROD with RULES




                                                                                                                                                                         in the Environmental Protection Agency
                                                                                                             Drug, and Cosmetic Act (FFDCA).
                                                  [EPA–HQ–OPP–2016–0560; FRL–9963–66]                                                                                    Docket Center (EPA/DC), West William
                                                                                                             DATES: This regulation is effective                         Jefferson Clinton Bldg., Rm. 3334, 1301
                                                  Florpyrauxifen-Benzyl; Pesticide                           October 6, 2017. Objections and                             Constitution Ave. NW., Washington, DC
                                                  Tolerances                                                 requests for hearings must be received                      20460–0001. The Public Reading Room
                                                                                                             on or before December 5, 2017, and                          is open from 8:30 a.m. to 4:30 p.m.,
                                                  AGENCY: Environmental Protection                           must be filed in accordance with the                        Monday through Friday, excluding legal
                                                  Agency (EPA).                                              instructions provided in 40 CFR part                        holidays. The telephone number for the


                                             VerDate Sep<11>2014     16:21 Oct 05, 2017   Jkt 244001    PO 00000   Frm 00031   Fmt 4700       Sfmt 4700   E:\FR\FM\06OCR1.SGM   06OCR1


                                                  46686              Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations

                                                  Public Reading Room is (202) 566–1744,                  and hearing requests are provided in 40               There were no comments received in
                                                  and the telephone number for the OPP                    CFR 178.25(b).                                        response to the notice of filing.
                                                  Docket is (703) 305–5805. Please review                   In addition to filing an objection or                  Based upon review of the data
                                                  the visitor instructions and additional                 hearing request with the Hearing Clerk                supporting the petition, EPA is
                                                  information about the docket available                  as described in 40 CFR part 178, please               establishing tolerance levels that vary
                                                  at http://www.epa.gov/dockets.                          submit a copy of the filing (excluding                from the petitioned-for levels for certain
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                          any Confidential Business Information                 crops and is correcting commodity
                                                  Michael L. Goodis, Director,                            (CBI)) for inclusion in the public docket.            definitions, as needed, to be consistent
                                                  Registration Division (7505P), Office of                Information not marked confidential                   with current EPA policy. These changes
                                                  Pesticide Programs, Environmental                       pursuant to 40 CFR part 2 may be                      are explained further in Unit IV.C.
                                                  Protection Agency, 1200 Pennsylvania                    disclosed publicly by EPA without prior
                                                                                                                                                                III. Aggregate Risk Assessment and
                                                  Ave. NW., Washington, DC 20460–0001;                    notice. Submit the non-CBI copy of your
                                                                                                                                                                Determination of Safety
                                                  Main telephone number: (703) 305–                       objection or hearing request, identified
                                                                                                          by docket ID number EPA–HQ–OPP–                          Section 408(b)(2)(A)(i) of FFDCA
                                                  7090; email address: RDFRNotices@                                                                             allows EPA to establish a tolerance (the
                                                                                                          2016–0560, by one of the following
                                                  epa.gov.                                                                                                      legal limit for a pesticide chemical
                                                                                                          methods:
                                                  SUPPLEMENTARY INFORMATION:                                • Federal eRulemaking Portal: http://               residue in or on a food) only if EPA
                                                                                                          www.regulations.gov. Follow the online                determines that the tolerance is ‘‘safe.’’
                                                  I. General Information                                                                                        Section 408(b)(2)(A)(ii) of FFDCA
                                                                                                          instructions for submitting comments.
                                                  A. Does this action apply to me?                        Do not submit electronically any                      defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                          information you consider to be CBI or                 reasonable certainty that no harm will
                                                     You may be potentially affected by                                                                         result from aggregate exposure to the
                                                                                                          other information whose disclosure is
                                                  this action if you are an agricultural                                                                        pesticide chemical residue, including
                                                                                                          restricted by statute.
                                                  producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   all anticipated dietary exposures and all
                                                  pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 other exposures for which there is
                                                  list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 reliable information.’’ This includes
                                                  Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       exposure through drinking water and in
                                                  not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    residential settings, but does not include
                                                  provides a guide to help readers                        arrangements for hand delivery or                     occupational exposure. Section
                                                  determine whether this document                         delivery of boxed information, please                 408(b)(2)(C) of FFDCA requires EPA to
                                                  applies to them. Potentially affected                   follow the instructions at http://                    give special consideration to exposure
                                                  entities may include:                                   www.epa.gov/dockets/contacts.html.                    of infants and children to the pesticide
                                                     • Crop production (NAICS code 111).                    Additional instructions on                          chemical residue in establishing a
                                                     • Animal production (NAICS code                      commenting or visiting the docket,                    tolerance and to ‘‘ensure that there is a
                                                  112).                                                   along with more information about                     reasonable certainty that no harm will
                                                     • Food manufacturing (NAICS code                     dockets generally, is available at http://            result to infants and children from
                                                  311).                                                   www.epa.gov/dockets.                                  aggregate exposure to the pesticide
                                                     • Pesticide manufacturing (NAICS                                                                           chemical residue. . . .’’
                                                  code 32532).                                            II. Summary of Petitioned-For
                                                                                                                                                                   Consistent with FFDCA section
                                                                                                          Tolerance
                                                                                                                                                                408(b)(2)(D), and the factors specified in
                                                  B. How can I get electronic access to                      In the Federal Register of December                FFDCA section 408(b)(2)(D), EPA has
                                                  other related information?                              20, 2016 (81 FR 92758) (FRL–9956–04),                 reviewed the available scientific data
                                                     You may access a frequently updated                  EPA issued a document pursuant to                     and other relevant information in
                                                  electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    support of this action. EPA has
                                                  regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                sufficient data to assess the hazards of
                                                  the Government Printing Office’s e-CFR                  pesticide petition (PP 5F8403) by Dow                 and to make a determination on
                                                  site at http://www.ecfr.gov/cgi-bin/text-               AgroSciences LLC, 9330 Zionsville                     aggregate exposure for florpyrauxifen-
                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Road, Indianapolis, IN 46268. The                     benzyl including exposure resulting
                                                  40tab_02.tpl.                                           petition requested that 40 CFR part 180               from the tolerances established by this
                                                                                                          be amended by establishing tolerances                 action. EPA’s assessment of exposures
                                                  C. How can I file an objection or hearing               for residues of the herbicide
                                                  request?                                                                                                      and risks associated with
                                                                                                          florpyrauxifen-benzyl (2-                             florpyrauxifen-benzyl follows.
                                                    Under FFDCA section 408(g), 21                        Pyridinecarboxylic acid, 4-amino-3-                      EPA has evaluated the available
                                                  U.S.C. 346a, any person may file an                     chloro-6-(4-chloro-2-fluoro-3-                        toxicity data and considered its validity,
                                                  objection to any aspect of this regulation              methoxyphenyl)-5-fluoro-,                             completeness, and reliability as well as
                                                  and may also request a hearing on those                 phenylmethyl ester) and florpyrauxifen                the relationship of the results of the
                                                  objections. You must file your objection                (metabolite; 2-Pyridinecarboxylic acid,               studies to human risk. EPA has also
                                                  or request a hearing on this regulation                 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-              considered available information
                                                  in accordance with the instructions                     methoxyphenyl)-5-fluoro-), in or on the               concerning the variability of the
                                                  provided in 40 CFR part 178. To ensure                  raw agricultural commodities rice, grain              sensitivities of major identifiable
                                                  proper receipt by EPA, you must                         (dehulled) at 0.01 parts per million                  subgroups of consumers, including
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                                                  identify docket ID number EPA–HQ–                       (ppm); rice, grain at 0.2 ppm; fish,                  infants and children.
                                                  OPP–2016–0560 in the subject line on                    freshwater at 2 ppm; shellfish,                          Florpyrauxifen-benzyl is not
                                                  the first page of your submission. All                  crustacean at 0.5 ppm; and shellfish,                 genotoxic and there were no treatment-
                                                  objections and requests for a hearing                   mollusk at 9 ppm. That document                       related findings up to the limit dose
                                                  must be in writing, and must be                         referenced a summary of the petition                  (1,000 milligrams/kilogram (mg/kg)/day)
                                                  received by the Hearing Clerk on or                     prepared by Dow AgroSciences LLC, the                 or highest doses tested in the acute,
                                                  before December 5, 2017. Addresses for                  registrant, which is available in the                 short-term, sub-chronic, or chronic oral
                                                  mail and hand delivery of objections                    docket, http://www.regulations.gov.                   toxicity studies, two-generation


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                                                                     Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations                                        46687

                                                  reproduction or developmental toxicity                  of a different factor. EPA considers the              covered by the rice grain tolerance.
                                                  studies or in the neurotoxicity study.                  toxicity database to be complete and                  Based on the Organization of Economic
                                                  Chronic administration of                               there are no residual uncertainties in the            Cooperation and Development (OECD)
                                                  florpyrauxifen-benzyl did not show any                  florpyrauxifen-benzyl exposure                        statistical calculation applied to the
                                                  carcinogenicity potential and did not                   database. Because there are no threshold              field trial (U.S.) residue data, EPA
                                                  cause any adverse effects in mice, rats                 effects in the florpyrauxifen-benzyl                  determined that the appropriate
                                                  or dogs even up to the highest doses                    database, the requirement to retain this              tolerance level for rice, grain is 0.30
                                                  tested.                                                 safety factor is inapplicable to the                  ppm. The OECD calculation procedures
                                                     Specific information on the studies                  current tolerance action.                             are globally recognized for calculating
                                                  received and the nature of the adverse                     Based on the lack of toxicity from                 MRLs to facilitate the harmonization of
                                                  effects caused by florpyrauxifen-benzyl                 exposure to residues of florpyrauxifen-               regulatory limits.
                                                  as well as the no-observed-adverse-                     benzyl, EPA concludes that there is a                    For fish-shellfish, mollusc the
                                                  effect-level (NOAEL) and the lowest-                    reasonable certainty that no harm will                tolerance level is established at 20 ppm,
                                                  observed-adverse-effect-level (LOAEL)                   result to the general population, or to               rather than the requested 9 ppm, based
                                                  from the toxicity studies can be found                  infants and children from aggregate                   on the residue data. Also, to be
                                                  at http://www.regulations.gov in                        exposure to florpyrauxifen-benzyl.                    consistent with current EPA policy, the
                                                  document ‘‘Florpyrauxifen-benzyl: New                                                                         commodity definitions were revised as
                                                  Active Ingredient, First Food Use.                      IV. Other Considerations
                                                                                                                                                                fish-freshwater finfish; fish-shellfish,
                                                  Human Health Risk Assessment for the                    A. Analytical Enforcement Methodology                 crustacean; and fish-shellfish, mollusc,
                                                  Establishment of Permanent Tolerances                                                                         and the Agency added a significant
                                                  on Rice, Fish, and Shellfish and                           Adequate analytical enforcement
                                                                                                          methodology which uses high-                          figure to the tolerances for rice, grain;
                                                  Registration for Uses on Rice and                                                                             fish-freshwater finfish; and fish-
                                                  Freshwater Aquatic Weed Control’’                       performance liquid chromatography
                                                                                                          with tandem mass spectrometry (HPLC/                  shellfish, crustacean.
                                                  dated December 1, 2016 in docket ID
                                                  number EPA–HQ–OPP–2016–0560.                            MS–MS) to quantitate residues of                      V. Conclusion
                                                     Because no single or repeated dose                   florpyrauxifen-benzyl and
                                                  study performed by any route of                         florpyrauxifen is available for                          Despite the lack of toxicity, the EPA
                                                  exposure produced an adverse effect                     enforcement.                                          is establishing tolerances as requested
                                                  following florpyrauxifen-benzyl                            The method may be requested from:                  by the petitioner for international trade
                                                  exposure, toxicity endpoints and points                 Chief, Analytical Chemistry Branch,                   purposes. Therefore, tolerances are
                                                  of departure were not selected for                      Environmental Science Center, 701                     established for residues of
                                                  florpyrauxifen-benzyl exposure                          Mapes Rd., Ft. Meade, MD 20755–5350;                  florpyrauxifen-benzyl, including its
                                                  scenarios and a quantitative risk                       telephone number: (410) 305–2905;                     metabolites and degradates, in or on
                                                  assessment was not conducted. Instead,                  email address: residuemethods@                        rice, grain at 0.30 ppm; fish-freshwater
                                                  a qualitative human health risk                         epa.gov.                                              finfish at 2.0 ppm; fish-shellfish,
                                                  assessment has been conducted to                                                                              crustacean at 0.50 ppm; and fish-
                                                                                                          B. International Residue Limits                       shellfish, mollusc at 20 ppm.
                                                  support the proposed uses of
                                                  florpyrauxifen-benzyl.                                     In making its tolerance decisions, EPA             VI. Statutory and Executive Order
                                                     Florpyrauxifen-benzyl is proposed for                seeks to harmonize U.S. tolerances with               Reviews
                                                  use on rice and aquatic sites. Humans                   international standards whenever
                                                  could potentially be exposed to                         possible, consistent with U.S. food                      This action establishes tolerances
                                                  florpyrauxifen-benzyl residues in food                  safety standards and agricultural                     under FFDCA section 408(d) in
                                                  (including fish and shellfish) because                  practices. EPA considers the                          response to a petition submitted to the
                                                  florpyrauxifen-benzyl may be applied                    international maximum residue limits                  Agency. The Office of Management and
                                                  directly to growing rice and aquatic                    (MRLs) established by the Codex                       Budget (OMB) has exempted these types
                                                  sites. These applications can also result               Alimentarius Commission (Codex), as                   of actions from review under Executive
                                                  in florpyrauxifen-benzyl reaching                       required by FFDCA section 408(b)(4).                  Order 12866, entitled ‘‘Regulatory
                                                  surface and ground water, both of which                 The Codex Alimentarius is a joint                     Planning and Review’’ (58 FR 51735,
                                                  can serve as sources of drinking water.                 United Nations Food and Agriculture                   October 4, 1993). Because this action
                                                  There are no proposed uses in                           Organization/World Health                             has been exempted from review under
                                                  residential settings and there are no                   Organization food standards program,                  Executive Order 12866, this action is
                                                  anticipated residential exposures.                      and it is recognized as an international              not subject to Executive Order 13211,
                                                     Section 408(b)(2)(C) of FFDCA                        food safety standards-setting                         entitled ‘‘Actions Concerning
                                                  provides that EPA shall apply an                        organization in trade agreements to                   Regulations That Significantly Affect
                                                  additional tenfold (10X) margin of safety               which the United States is a party. EPA               Energy Supply, Distribution, or Use’’ (66
                                                  for infants and children in the case of                 may establish a tolerance that is                     FR 28355, May 22, 2001) or Executive
                                                  threshold effects to account for prenatal               different from a Codex MRL; however,                  Order 13045, entitled ‘‘Protection of
                                                  and postnatal toxicity and the                          FFDCA section 408(b)(4) requires that                 Children from Environmental Health
                                                  completeness of the database on toxicity                EPA explain the reasons for departing                 Risks and Safety Risks’’ (62 FR 19885,
                                                  and exposure, unless EPA determines                     from the Codex level.                                 April 23, 1997). This action does not
                                                  based on reliable data that a different                    The Codex has not established a MRL                contain any information collections
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                                                  margin of safety will be safe for infants               for florpyrauxifen-benzyl.                            subject to OMB approval under the
                                                  and children. This additional margin of                                                                       Paperwork Reduction Act (PRA) (44
                                                  safety is commonly referred to as the                   C. Revisions to Petitioned-For                        U.S.C. 3501 et seq.), nor does it require
                                                  FQPA Safety Factor (SF). In applying                    Tolerances                                            any special considerations under
                                                  this provision, EPA either retains the                    Although a tolerance for rice, grain                Executive Order 12898, entitled
                                                  default value of 10X, or uses a different               (dehulled) was requested, EPA                         ‘‘Federal Actions to Address
                                                  additional safety factor when reliable                  determined that no such tolerance is                  Environmental Justice in Minority
                                                  data available to EPA support the choice                required. Rice, grain (dehulled) is                   Populations and Low-Income


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                                                  46688              Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations

                                                  Populations’’ (59 FR 7629, February 16,                 Transfer and Advancement Act                          amino-3-chloro- 6-(4-chloro-2-fluoro-3-
                                                  1994).                                                  (NTTAA) (15 U.S.C. 272 note).                         methoxyphenyl)-5-fluoro-2-
                                                     Since tolerances and exemptions that                                                                       pyridinecarboxylate) and its acid
                                                                                                          VII. Congressional Review Act
                                                  are established on the basis of a petition                                                                    metabolite (4-amino-3-chloro-6-(4-
                                                                                                            Pursuant to the Congressional Review                chloro-2-fluoro-3-methoxyphenyl)-5-
                                                  under FFDCA section 408(d), such as                     Act (5 U.S.C. 801 et seq.), EPA will
                                                  the tolerance in this final rule, do not                                                                      fluoropyridine-2-carboxylic acid)
                                                                                                          submit a report containing this rule and              calculated as the stoichiometric
                                                  require the issuance of a proposed rule,                other required information to the U.S.
                                                  the requirements of the Regulatory                                                                            equivalent of florpyrauxifen-benzyl, in
                                                                                                          Senate, the U.S. House of                             or on the commodity.
                                                  Flexibility Act (RFA) (5 U.S.C. 601 et                  Representatives, and the Comptroller
                                                  seq.), do not apply.                                    General of the United States prior to                                                            Parts per
                                                                                                                                                                            Commodity
                                                     This action directly regulates growers,              publication of the rule in the Federal                                                            million
                                                  food processors, food handlers, and food                Register. This action is not a ‘‘major
                                                  retailers, not States or tribes, nor does               rule’’ as defined by 5 U.S.C. 804(2).                 Fish—freshwater finfish ........                   2.0
                                                  this action alter the relationships or                                                                        Fish—shellfish, crustacean ...                    0.50
                                                                                                          List of Subjects in 40 CFR Part 180                   Fish—shellfish, mollusc ........                    20
                                                  distribution of power and                                                                                     Rice, grain ............................          0.30
                                                  responsibilities established by Congress                  Environmental protection,
                                                  in the preemption provisions of FFDCA                   Administrative practice and procedure,
                                                                                                          Agricultural commodities, Pesticides                    (b) Section 18 emergency exemptions.
                                                  section 408(n)(4). As such, the Agency                                                                        [Reserved]
                                                  has determined that this action will not                and pests, Reporting and recordkeeping
                                                                                                          requirements.                                           (c) Tolerances with regional
                                                  have a substantial direct effect on States                                                                    registrations. [Reserved]
                                                  or tribal governments, on the                             Dated: September 8, 2017.                             (d) Indirect or inadvertent residues.
                                                  relationship between the national                       Richard P. Keigwin, Jr.,                              [Reserved]
                                                  government and the States or tribal                     Director, Office of Pesticide Programs.               [FR Doc. 2017–21614 Filed 10–5–17; 8:45 am]
                                                  governments, or on the distribution of
                                                                                                            Therefore, 40 CFR chapter I is                      BILLING CODE 6560–50–P
                                                  power and responsibilities among the
                                                                                                          amended as follows:
                                                  various levels of government or between
                                                  the Federal Government and Indian                       PART 180—[AMENDED]
                                                  tribes. Thus, the Agency has determined                                                                       FEDERAL COMMUNICATIONS
                                                  that Executive Order 13132, entitled                    ■ 1. The authority citation for part 180              COMMISSION
                                                  ‘‘Federalism’’ (64 FR 43255, August 10,                 continues to read as follows:
                                                  1999) and Executive Order 13175,                                                                              47 CFR Parts 1, 2, 15, 90, 95, and 97
                                                                                                              Authority: 21 U.S.C. 321(q), 346a and 371.
                                                  entitled ‘‘Consultation and Coordination
                                                                                                          ■ 2. Add § 180.695 to subpart C to read               [ET Docket No. 15–26; FCC 17–94]
                                                  with Indian Tribal Governments’’ (65 FR
                                                  67249, November 9, 2000) do not apply                   as follows:
                                                                                                                                                                Permitting Radar Services in the 76–81
                                                  to this action. In addition, this action                § 180.695 Florpyrauxifen-benzyl;                      GHz Band
                                                  does not impose any enforceable duty or                 Pesticide Tolerances.
                                                  contain any unfunded mandate as                                                                               Correction
                                                                                                             (a) General. Tolerances are
                                                  described under Title II of the Unfunded                established for residues of                             In rule document 2017–18463
                                                  Mandates Reform Act (UMRA) (2 U.S.C.                    florpyrauxifen-benzyl, including its                  beginning on page 43865 in the issue of
                                                  1501 et seq.).                                          metabolites and degradates, in or on the              Wednesday, September 20, 2017, make
                                                     This action does not involve any                     commodities in the table below.                       the following correction:
                                                  technical standards that would require                  Compliance with the tolerance levels
                                                                                                                                                                § 2.106     [Corrected]
                                                  Agency consideration of voluntary                       specified below is to be determined by
                                                  consensus standards pursuant to section                 measuring only the sum of                             ■ In Part 2, in § 2.106, on page 43869,
                                                  12(d) of the National Technology                        florpyrauxifen-benzyl (phenylmethyl 4-                the table should appear as follows:
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Document Created: 2017-10-06 00:08:35
Document Modified: 2017-10-06 00:08:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective October 6, 2017. Objections and requests for hearings must be received on or before December 5, 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).
ContactMichael 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
FR Citation82 FR 46685 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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