[Federal Register Volume 86, Number 152 (Wednesday, August 11, 2021)]
[Rules and Regulations]
[Pages 43964-43967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16969]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0113; FRL-8751-01-OCSPP]
Florasulam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance with regional
registrations for residues of florasulam in or on grass, forage, fodder
and hay, group 17. The Interregional Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective August 11, 2021.
Objections and requests for hearings must be received on or before
October 12, 2021, 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-2020-0113, 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.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on EPA/DC services and
docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting 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
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
[[Page 43965]]
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-2020-0113 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 12, 2021. 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-2020-0113, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. 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 June 24, 2020 (85 FR 37806) (FRL-10010-
82) and in the Federal Register of August 5, 2020 (85 FR 47330) (FRL-
10012-32), 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
0E8821) by IR-4, Rutgers, the State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. These petitions
requested that 40 CFR 180.633 be amended by establishing tolerances
with regional registrations for residues of the herbicide florasulam,
N-(2, 6-difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4) triazole (1, 5-
c)pyrimidine-2-sulfonamide, in or on grass, forage at 0.01 parts per
million (ppm); and grass, hay at 0.02 ppm. Those documents referenced a
summary of the petition prepared by Corteva Agriscience, the
registrant, which is available in the docket, https://www.regulations.gov/document/EPA-HQ-OPP-2020-0113-0003. There were no
comments received in response to these notices of filings.
EPA is establishing a tolerance for the crop group rather than
separate tolerances for forage and hay. The reason for this change is
explained 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 florasulam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with florasulam follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that would repeat
what has been previously published in tolerance rulemakings for the
same pesticide chemical. Where scientific information concerning a
particular pesticide chemical remains unchanged, the content of those
sections would not vary between tolerance rulemakings and republishing
the same sections is unnecessary and duplicative. EPA considers
referral back to those sections as sufficient to provide an explanation
of the information EPA considered in making its safety determination
for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for
florasulam, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to florasulam and established tolerances for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this
rulemaking, as they remain unchanged.
Toxicological profile. The Toxicological Profile of florasulam
remains unchanged from the Toxicological Profile in Unit III.A. of the
July 25, 2018 rulemaking (83 FR 35141) (FRL-9979-81). Refer to that
section for a discussion of the Toxicological Profile of florasulam.
Toxicological Points of Departure/Levels of Concern. The
Toxicological Points of Departure/Levels of Concern used for the safety
assessment remain unchanged from Unit III.B. of the July 25, 2018
rulemaking. For a summary, refer to that discussion.
Exposure assessment. Much of the exposure assessment remains the
same, although updates have occurred to accommodate exposures from the
petitioned-for tolerances. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, see Unit III.C. of the July 25, 2018
rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of florasulam on grass seedlings,
grasses grown for seed, and to add a default processing factor of 7.7x
for oat bran that was previously omitted. All other assumptions in the
exposure assessments for florasulam remain the same as in the July 25,
2018 rulemaking, including tolerance level residues, the other default
processing factors, and 100% crop treated. Additionally, the proposed
new use restricts the feeding of or grazing of livestock on grass
treated with florasulam; therefore, 40 CFR 180.6(a)(3) continues to
apply.
Drinking water and non-occupational exposures. Drinking water
exposures are
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not impacted by the new uses, and thus have not changed since the last
assessment. There were no changes to the drinking water analysis due to
the estimated drinking water concentrations (EDWC) for terrestrial
applications that were approximately 500- to 1,200-fold lower than
concern levels. Therefore, the Agency has concluded that previous EDWCs
are adequate.
Residential (non-occupational) exposures are also not impacted by
the new uses. There are no new proposed residential uses for florasulam
at this time; however, there are registered uses of florasulam on
turfgrass, including residential lawns, golf courses, sports fields,
sod farms and commercial turfgrass areas. Because all current
florasulam labels with turf uses require handlers to wear personal
protective equipment, EPA assumes that florasulam is applied by
professional applicators, not residential (homeowner) applicators.
Therefore, the current assessment does not consider exposure to
residential handlers. This is different than the assessment supporting
the July 25, 2018 rule, which relied on a 2009 assessment that included
inhalation exposure to residential handlers. EPA's policy has changed
since 2009 to reflect the assumption described above regarding labels
that require personal protective equipment.
Post-application residential exposures were considered as part of
the assessment. Due to lack of a dermal endpoint, only the incidental
oral exposures for children 1 to less than 2 years old from use on
residential turf were assessed. Margins of exposure (MOEs) ranged from
25,000 for hand-to-mouth short-term exposure to 11,000,000 for
incidental soil ingestion short-term exposure and were not of concern.
More detailed information about the Agency's analysis can be found at
http://www.regulations.gov in the document titled ``Florasulam: Draft
Human Health Risk Assessment for Registration Review'' in docket ID
number EPA-HQ-OPP-2020-0113.
Cumulative exposures. 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's assessment
of cumulative exposures has not changed since the July 25, 2018
rulemaking. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not found a common mechanism of toxicity as to florasulam and any
other substances and florasulam does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
action, therefore, EPA has not assumed that florasulam has a common
mechanism of toxicity with other substances.
Safety Factor for Infants and Children. The scientific information
underpinning EPA's prior safety factor determination remains unchanged
from the July 25, 2018 rulemaking. Therefore, EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the
July 25, 2018 rulemaking for a discussion of the Agency's rationale for
that determination.
Aggregate Risks and Determination of Safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic PAD (cPAD). Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate points of departure to
ensure that an adequate MOE exists. For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure.
An acute dietary risk assessment was not conducted as toxicological
effects attributable to a single dose were not identified. Chronic
dietary risks are below the Agency's level of concern of 100% of the
cPAD: They are less than 1% of the cPAD for the U.S. population and all
population subgroups. Florasulam is classified as ``Not Likely to be
Carcinogenic to Humans;'' therefore, a cancer dietary exposure analysis
was not performed.
Short-term aggregated risk included the incidental oral exposures
and the average dietary exposures from food and drinking water sources.
Short-term aggregated risk estimates for the most highly exposed child
population, children 1 to less than 2 years old, results in an MOE of
17,000 and is not of concern because it is greater than the level of
concern of 100. As stated in the July 25, 2018 rule, florasulam is not
registered for any use patterns that would result in intermediate-term
residential exposure due to the intermittent nature of applications.
Because there is no intermediate-term residential exposure and chronic
dietary exposure has been assessed under the appropriately protective
cPAD, EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for florasulam.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to florasulam residues. More detailed information
about the Agency's analysis can be found at http://www.regulations.gov
in the document titled ``Florasulam: Human Health Risk Assessment for
the Proposed New Use on Seedlings and Grasses Grown for Seed'' in
docket ID number EPA-HQ-OPP-2020-0113.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 25, 2018 rulemaking.
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 has not established MRLs for residues of florasulam in/on
grasses.
C. Revisions to Petitioned-For Tolerances
After the NOF was published, the petitioner revised their tolerance
request to establish a tolerance for grass, forage, fodder and hay,
group 17 at 0.02 ppm. The Agency determined that the residue data
support that tolerance and therefore is establishing the tolerance for
the crop group.
V. Conclusion
Therefore, regional tolerances are established for residues of
florasulam, N-(2, 6-difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4)
triazole (1, 5-c)pyrimidine-2-sulfonamide, in or on grass, forage,
fodder and hay, group 17 at 0.02 ppm.
VI. Statutory and Executive Order Reviews
This action establishes 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
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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 to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 29, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.633, add paragraph (c) to read as follows:
Sec. 180.633 Florasulam; tolerances for residues.
* * * * *
(c) Tolerances with regional registrations. Tolerances are
established for residues of the herbicide florasulam, including its
metabolites and degradates, in or on the commodities in table 2 to this
paragraph (c). Compliance with the tolerance levels specified in table
2 is to be determined by measuring only florasulam, N-(2, 6-
difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4) triazole (1, 5-
c)pyrimidine-2-sulfonamide, in or on the commodities:
Table 2 to Paragraph (c)
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Parts per
Commodity million
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Grass, forage, fodder and hay, group 17................ 0.02
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[FR Doc. 2021-16969 Filed 8-10-21; 8:45 am]
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