Rule2022-03924
Fluridone; Pesticide Tolerances for Emergency Exemptions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 28, 2022
Effective
February 28, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes time-limited tolerances for residues of the herbicide fluridone including its degradates and metabolites in or on peanut and peanut, hay. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on peanut. This regulation establishes a maximum permissible level for residues of fluridone in or on these commodities. The time-limited tolerances expire on December 31, 2024.
Full Text
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<title>Federal Register, Volume 87 Issue 39 (Monday, February 28, 2022)</title>
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[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10979-10982]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03924]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0337; FRL-9459-01-OCSPP]
Fluridone; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of the herbicide fluridone including its degradates and
metabolites in or on peanut and peanut, hay. This action is in response
to EPA's granting of an emergency exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on peanut. This regulation establishes a maximum
permissible level for residues of fluridone in or on these commodities.
The time-limited tolerances expire on December 31, 2024.
DATES: This regulation is effective February 28, 2022. Objections and
requests for hearings must be received on or before April 29, 2022, 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-2021-0337, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 and OPP docket is (202) 566-1744.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#a5f7e1e3f7ebcad1ccc6c0d6e5c0d5c48bc2cad3"><span class="__cf_email__" data-cfemail="6f3d2b293d21001b060c0a1c2f0a1f0e41080019">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
[[Page 10980]]
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 Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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-
2021-0337 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 April 29, 2022. 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-2021-0337, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is
establishing time-limited tolerances for residues of fluridone, in or
on peanut at 0.1 parts per million (ppm) and peanut, hay at 0.1 ppm.
These time-limited tolerances expire on December 31, 2024.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement of a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18-related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Fluridone on Peanut and Peanut, Hay and
FFDCA Tolerances
The Arkansas and Missouri Departments of Agriculture submitted
specific emergency exemptions for the use of fluridone on peanut to
control Palmer amaranth, Amaranthus palmeri, populations in peanut
fields where glyphosate-resistant Palmer amaranth biotypes are present.
According to the States, peanut growers in Arkansas and Missouri are
experiencing widespread multiple herbicide-resistant populations of
Palmer amaranth. These States reported that an urgent and non-routine
situation exists because a registered effective soil residual herbicide
is currently unavailable to reduce the impact and prevent the expansion
of this destructive weed species. Significant economic losses are
expected for peanut growers due to yield and quality decreases without
a suitable pesticide control.
After having reviewed the submission, EPA determined that an
emergency condition exists for these States, and that the criteria for
approval of these emergency exemptions have been met.
As part of its evaluation of these emergency exemption
applications, EPA assessed the potential risks presented by residues of
fluridone in or on peanut at 0.1 ppm and peanut, hay at 0.1 ppm. In
doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerances under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on these
emergency exemptions in order to address an urgent non-routine
situation in these States and to ensure that the resulting food is safe
and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
Although these time-limited tolerances expire on December 31, 2024,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on peanut
after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by these time-limited tolerances
at the time of that application. EPA will take action to revoke these
time-limited tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
fluridone meets FIFRA's registration requirements for use on peanut or
whether permanent tolerances for this use would be
[[Page 10981]]
appropriate. Under these circumstances, EPA does not believe that these
time-limited tolerance decisions serve as a basis for registration of
fluridone by a State for special local needs under FIFRA section 24(c).
Nor do these tolerances by themselves serve as the authority for
persons in States other than Arkansas and Missouri to use this
pesticide on the applicable crops under FIFRA section 18 absent the
issuance of an emergency exemption applicable within that State. For
additional information regarding the emergency exemptions for
fluridone, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. 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 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 expected as a result of these emergency exemption requests and
the time-limited tolerances for residues of fluridone on peanut at 0.1
ppm and peanut, hay at 0.1 ppm. EPA's assessment of exposures and risks
associated with establishing these time-limited tolerances follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considers in making its safety determination for the new rulemaking.
In the Federal Register of May 18, 2020 (85 FR 29633) (FRL-10007-
09), EPA published a final rule that established tolerances for
residues of fluridone in or on multiple commodities based on the
Agency's determination that aggregate exposure to fluridone resulting
from the residues subject to those tolerances is safe for the U.S.
general population, including infants and children. EPA is
incorporating sections from that final rule as described further in
this rulemaking, as they remain unchanged.
Toxicological profile. The toxicological profile for fluridone has
not changed since the May 18, 2020, final rule was published;
therefore, EPA is relying upon the discussion of that profile in Unit
III. A. as part of this rulemaking.
Toxicological points of departure/Levels of concern. The
toxicological points of departure and levels of concern for fluridone
have not changed since the May 18, 2020, final rule was published;
therefore, EPA is relying upon the discussion in Unit III. B. as part
of this rulemaking.
Exposure assessment. Much of the exposure assessment for fluridone
remains unchanged from the discussion in Unit III. C. of the May 18,
2020, final rule, except that EPA considered the additional dietary
exposure from the time-limited tolerances established by this action.
Specifically, EPA conducted acute and chronic dietary exposure
assessments to determine if the emergency use on peanut increases the
dietary exposure to fluridone. Updated acute and chronic Dietary
Exposure Evaluation Model (DEEM) runs were conducted with peanut
included at a 0.1 ppm residue level. These results compared to the most
recent dietary assessment supporting the May 18, 2020, final rule
showed no exposure changes to two significant figures. Therefore, the
previous assessment is protective of dietary exposure potential from
the emergency use of fluridone on peanut.
Safety factor for infants and children. EPA continues to conclude
that there is reliable data showing that the safety of infants and
children would be adequately protected if the Food Quality Protection
Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for
that determination are articulated in Unit III. D. of the May 18, 2020,
final rule.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and chronic population-adjusted dose (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 (PODs) to ensure that an adequate
margin of exposure (MOE) exists.
The results of the acute and chronic analyses for fluridone do not
exceed the Agency's level of concern (LOC). That is, all risk estimates
were <100% of the aPAD or <100 of the cPAD and are not of concern for
the general U.S. population and all population subgroups. The acute
dietary exposure from food and water will occupy 2.3% of the aPAD for
all infants (1-year old), the population with the highest estimated
risk. Chronic exposure to fluridone from food and water will utilize 7%
of the cPAD for children aged 1 to 2, the population with the highest
estimated risk.
The short-term aggregate exposure assessment for fluridone is based
on food and drinking water as well as residential uses. For short-term
aggregate risk assessment, potential residential exposures (dermal,
inhalation, and incidental ingestion from swimming in treated waters
for children; dermal and inhalation from applications via pouring into
recreational ponds for adults) were combined with background dietary
exposures. The combined short-term food, water, and residential
exposures result in aggregate MOEs for of 1,300 for adults and 1,600
for children, which are greater than the LOC of 100. Because EPA's
level of concern for fluridone is an MOE of 100 or below, these MOEs
are not of concern. Fluridone is not registered for any use patterns
that would result in intermediate-term residential exposure.
Further, since there is no evidence of carcinogenicity in the
toxicological database for fluridone, EPA concluded that fluridone is
not carcinogenic and is classified as ``not likely'' to be a human
carcinogen.
Therefore, based on the risk assessments and information described
above, EPA concludes that there is reasonable certainty that no harm
will result to the U.S. general population, or to infants and children
from aggregate exposure to fluridone residues. More detailed
information on the subject
[[Page 10982]]
action to establish time-limited tolerances in or on peanut and peanut,
hay can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document
entitled, ``Fluridone: ID# 21AR03 Section 18 Specific Exemption for Use
on Peanut in Arkansas.'' This document can be found in docket ID number
EPA-HQ-OPP-2021-0337.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (high performance liquid
chromatography (HPLC) method (originally submitted as method AM-AA-CA-
RO52-AA-755)) is available to enforce the tolerance expression.
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:
<a href="/cdn-cgi/l/email-protection#2c5e495f454859494149584443485f6c495c4d024b435a"><span class="__cf_email__" data-cfemail="d4a6b1a7bdb0a1b1b9b1a0bcbbb0a794b1a4b5fab3bba2">[email protected]</span></a>.
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 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 fluridone.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
fluridone, in or on peanut at 0.1 ppm and peanut, hay at 0.1 ppm. These
tolerances expire on December 31, 2024.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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 Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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, but does not regulate 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, or 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).
VIII. 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: February 17, 2022.
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. Amend Sec. 180.420, by adding paragraph (b) to read as follows:
Sec. 180.420 Fluridone; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide fluridone, including its
metabolites and degradates, in or on the specified agricultural
commodities in the table, resulting from use of the pesticide pursuant
to FFIFRA section 18 emergency exemptions. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only fluridone, (1-methyl-3-phenyl-5-[3-
trifluoromethyl)phenyl]-4(1H)-pyridinone). The tolerances expire on the
date specified in table 3.
Table 3 to Paragraph (b)
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Peanut......................................... 0.1 12/31/2024
Peanut, hay.................................... 0.1 12/31/2024
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-03924 Filed 2-25-22; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.