[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]



40 CFR Part 180

[EPA-HQ-OPP-2020-0113; FRL-8751-01-OCSPP]

Florasulam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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 

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 

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].


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.

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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 
     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 

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 
    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 
    Drinking water and non-occupational exposures. Drinking water 
exposures are

[[Page 43966]]

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 

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

[[Page 43967]]

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, 
    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:


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

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

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)
                                                            Parts per
                       Commodity                             million
Grass, forage, fodder and hay, group 17................            0.02

* * * * *
[FR Doc. 2021-16969 Filed 8-10-21; 8:45 am]