Florpyrauxifen-benzyl; Exemption From the Requirement of a Tolerance.

Note from Fluoride Action Network

According to the September 8, 2017, Final Registration Decision on the New Active Ingredient Florpyrauxifen-benzyl: Although florpyrauxifen-benzyl is a new active ingredient, penoxsulam and cyhalofop-butyl, the co-formulated active ingredients in GF-3565 or GF-3480, respectively, are both currently registered active ingredients with labeled use on rice. Since penoxsularn and cyhalofop-butyl will be co-formulated in products only proposed for use on rice, no new exposures for these active ingredients are being considered with this registration action, and no new assessments were performed for penoxsulam and cyhalofop-butyl. Therefore, this document discusses the results of the EPA’s findings on the assessment of the new active ingredient florpyrauxifen-benzyl and its use in rice and aquatic (in-water and foliar) use sites.

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the florpyrauxifen-benzyl on all food
and feed commodities when applied or used as an herbicide under good
agricultural practices. This regulation eliminates the need to
establish a maximum permissible level for residues of florpyrauxifen-
benzyl.

DATES: This regulation is effective September 26, 2019. Objections and
requests for hearings must be received on or before November 25, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0645, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0645 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
November 25, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0645, 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 Action

In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-
9985-67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F8675) by Dow AgroSciences, 9330 Zionsville Road,
Indianapolis, IN 46268. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of florpyrauxifen-benzyl. That document
referenced a summary of the petition prepared by the petitioner, Dow
AgroSciences, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which requires EPA to give special
consideration to exposure of infants and children to the pesticide

[[Page 50765]]

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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

A. Toxicological Profile

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information 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. The nature of the toxic effects caused by
florpyrauxifen-benzyl are discussed in this unit.
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, 2-generation 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. Given the
absence of adverse effects or toxicity in the database, the Agency did
not establish any toxicity endpoints or points of departure for
conducting a quantitative risk assessment. In a qualitative assessment
of risk, the Agency does not use uncertainty factors, which means that
the safety factor required section 408(b)(2)(C) of FFDCA in the case of
threshold effects for the protection of infants and children is not
applicable. The Agency has determined that there are no residual
uncertainties in the toxicity or exposure databases, and there is no
evidence of increased susceptibility of infants or children from
exposure to florpyrauxifen-benzyl. Based on its review of the available
data, the Agency concludes that a qualitative assessment without
uncertainty or safety factors would be safe for infants and children.
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 the document titled ``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'' in
docket ID number EPA-HQ-OPP-2018-0645.

B. Aggregate Exposures

In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
There is potential for exposure to florpyrauxifen-benzyl via food
and drinking water based on the proposed and approved uses. In
addition, there is a potential for non-occupational, non-dietary
exposure to swimmers in waters treated with florpyrauxifen-benzyl. But
because no adverse effects were observed in the submitted toxicological
studies for florpyrauxifen-benzyl regardless of the route of exposure,
a qualitative assessment of risk is appropriate for this compound.

C. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has not found florpyrauxifen-benzyl to share a common mechanism
of toxicity with any other substances, and florpyrauxifen-benzyl does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that florpyrauxifen-benzyl does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Determination of Safety for U.S. Population, Infants and Children

Based on the information in this preamble and the supporting
documentation, EPA concludes that there is a reasonable certainty of no
harm from aggregate exposure to florpyrauxifen-benzyl residues.
Accordingly, EPA finds that exempting florpyrauxifen-benzyl residues
from the requirement of a tolerance when applied or used as an
herbicide in accordance with good agricultural practices will be safe.

IV. Analytical Enforcement Methodology

An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation because of the lack of toxicity concern about the presence
of residues.

V. Conclusion

Therefore, an exemption is established for residues of
florpyrauxifen-benzyl, including its metabolites and degradates, in or
on all food commodities, when it is applied as an herbicide according
to good agricultural practices. In addition, although not requested in
the petition, EPA is removing from the Title 40 of the Code of Federal
Regulations section 180.695 and the established tolerances on fish--
freshwater finfish; fish--shellfish, crustacean; fish--shellfish,
mollusc; and rice, grain. The residues on those commodities are
subsumed within the new exemption, so the existing numerical tolerances
are redundant and no longer necessary.

VI. Statutory and Executive Order Reviews

This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive

[[Page 50766]]

Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is
it considered a regulatory action under Executive Order 13771, entitled
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339,
February 3, 2017). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption 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: August 29, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

Sec. 180.695 [Removed]

0
2. Remove Sec. 180.695.

0
3. Add Sec. 180.1371 to subpart D to read as follows:

Sec. 180.1371 Florpyrauxifen-benzyl; exemption from the requirement
of a tolerance.

An exemption from the requirement of a tolerance is established for
residues of florpyrauxifen-benzyl, including its metabolites and
degradates, in or on all food and feed commodities, when it is applied
as an herbicide in accordance with good agricultural practices.

[FR Doc. 2019-20530 Filed 9-25-19; 8:45 am]
BILLING CODE 6560-50-P

*Original Final Rule online at

https://www.govinfo.gov/content/pkg/FR-2019-09-26/html/2019-20530.htm

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Fluoride Action Network

Florpyrauxifen-benzyl; Exemption From the Requirement of a Tolerance.

Note from Fluoride Action Network

See also