[Federal Register Volume 82, Number 193 (Friday, October 6, 2017)]
[Rules and Regulations]
[Pages 46685-46688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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