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.

See also

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-

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 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

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:


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

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: 
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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at

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, 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 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 

    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

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:


 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]

 2. Remove Sec.  180.695.

 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]

*Original Final Rule online at