[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Rules and Regulations]
[Pages 21944-21948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08598]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0478; FRL-10020-49]
Flupyradifurone; 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 insecticide flupyradifurone including its degradates
and metabolites in or on sugarcane, cane and sugarcane, molasses. This
action is associated with the utilization of a crisis exemption under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on sugarcane. This regulation
establishes a maximum permissible level for residues of flupyradifurone
in or on these commodities. The time-limited tolerances expire on
December 31, 2023.
DATES: This regulation is effective April 26, 2021. Objections and
requests for hearings must be received on or before June 25, 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-2020-0478, 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 concerns related to COVID-19, 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 Avenue 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 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 21945]]
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-
2020-0478 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 June 25, 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-2020-0478, 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. 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(1)(6), is
establishing time-limited tolerances for residues of flupyradifurone in
or on sugarcane, cane at 3 parts per million (ppm) and sugarcane,
molasses at 90 ppm. These time-limited tolerances expire on December
31, 2023.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for 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 Flupyradifurone on Sugarcane, Cane and
Sugarcane, Molasses and FFDCA Tolerances
The Louisiana Department of Agriculture and Forestry (LDAF) asserts
that an emergency condition exists in accordance with the criteria for
approval of an emergency exemption and has utilized a crisis exemption
under FIFRA section 18 to allow the use of flupyradifurone for control
of sugarcane aphid infestations in Louisiana sugarcane. According to
LDAF, the sugar industry is vital to Louisiana's economy and sugarcane
aphids which were once sporadic in the state are now widespread as
outbreaks have become more frequent in recent years. After having
reviewed the crisis exemption, EPA concurred on the 15-day stand-alone
emergency action, which expired on August 5, 2020.
As part of its evaluation of the crisis exemption, EPA assessed the
potential risks presented by residues of flupyradifurone in or on
sugarcane, cane at 3 ppm and sugarcane, molasses at 90 ppm. In doing
so, EPA considered the safety standard in FFDCA section 408(b)(2), and
EPA decided that the necessary tolerance 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 the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although these time-limited tolerances expire on
December 31, 2023, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on sugarcane 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
flupyradifurone meets FIFRA's registration requirements for use on
sugarcane or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
flupyradifurone by a State for special local needs under FIFRA section
24(c). Nor does this tolerance by itself serve as the authority for
persons in any State other than Louisiana 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 exemption for
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flupyradifurone, 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 the 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 the 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 the 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 therein, 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 this emergency exemption
request and the time-limited tolerances for residues of flupyradifurone
on sugarcane, cane at 3 ppm and sugarcane, molasses at 90 ppm.
On September 23, 2016 (81 FR 65552) (FRL-9951-68) and August 21,
2020 (85 FR 51668-51672) (FRL-10010-98), EPA published final rules that
established tolerances for residues of flupyradifurone in or on
multiple commodities based on the Agency's determination that aggregate
exposure to flupyradifurone resulting from the residues subject to
those tolerances is safe for the U.S. general population, including
infants and children. The toxicity profile for flupyradifurone has not
changed since the September 23, 2016 (81 FR 65552) (FRL-9951-68) rule
was published, therefore EPA is relying upon the discussion of that
profile (Unit III.A.) and the identified toxicological endpoints (Unit
III.A.) and the identified toxicological endpoints (Unit III B.), as
part of this rulemaking.
EPA's most recent exposure assessment for flupyradifurone appears
in the comprehensive risk assessment dated June 30, 2020 and entitled:
``Flupyradifurone: Human Health Risk Assessment for Uses on Grass
Forage Fodder and Hay Group 17, Pineapple, Rapeseed Subgroup 20A,
Sesame Seed, Stalk and Stem Vegetable Subgroup 22A (except Prickly Pear
Pads and Prickly Pear Texas Pads), Sunflower Subgroup 20B, Sweet
Sorghum, Tropical and Subtropical Palm Fruit Edible Peel Subgroup 23C,
Crop Group Expansions/Conversions of Tolerances to Brassica Leafy
Greens Subgroup 4-16B, Leafy Greens Subgroup 4-16A, Leaf Petiole
Vegetable Subgroup 22B, Tropical and Subtropical Inedible Peel Cactus
Subgroup 24D, Vegetable Brassica Head and Stem Group 5-16 and Establish
Individual Tolerances on Lettuce, Fennel Florence, Kohlrabi; and
Coffee,'' as that assessment included dietary and aggregate exposures
to flupyradifurone in or on multiple agricultural and non-agricultural
commodities that are complete except for exposures due to the emergency
use addressed in this document.
For aggregate risk assessment, risk estimates resulting from food,
drinking water, and residential uses are combined. Acute, short-and
intermediate-term, and long-term (chronic) aggregate assessments were
performed for flupyradifurone. Further information about EPA's risk
assessment and determination of safety supporting the tolerances
established in the August 21, 2020 final rule can be found at http://www.regulations.gov in the document entitled ``Flupyradifurone: Human
Health Risk Assessment for Uses on Grass Forage Fodder and Hay Group
17, Pineapple, Rapeseed Subgroup 20A, Sesame Seed, Stalk and Stem
Vegetable Subgroup 22A (except Prickly Pear Pads and Prickly Pear Texas
Pads), Sunflower Subgroup 20B, Sweet Sorghum, Tropical and Subtropical
Palm Fruit Edible Peel Subgroup 23C, Crop Group Expansions/Conversions
of Tolerances to Brassica Leafy Greens Subgroup 4-16B, Leafy Greens
Subgroup 4-16A, Leaf Petiole Vegetable Subgroup 22B, Tropical and
Subtropical Inedible Peel Cactus Subgroup 24D, Vegetable Brassica Head
and Stem Group 5-16 and Establish Individual Tolerances on Lettuce,
Fennel Florence, Kohlrabi; and Coffee,'' dated June 30, 2020 (docket ID
EPA-HQ-OPP-2019-0460).
EPA conducted unrefined and slightly refined chronic dietary
analyses for all current uses of flupyradifurone together with the
emergency use in or on sugarcane, cane and sugarcane, molasses. The
assessments incorporated tolerance-level residues, average residues
(chronic), 2018 default or empirical processing factors, conservative
drinking water estimates, and assumed that 100% of the proposed crops
were treated. The results of the acute and chronic analyses do not
exceed the Agency's level of concern (LOC). That is, <100% of the acute
population adjusted dose (aPAD) or <100% of the chronic population
adjusted dose (cPAD) are not of concern for the general U.S. population
and all population subgroups. At the 95th percentile of exposure, the
acute dietary (food and drinking water) risk estimates utilized 24% of
the aPAD for the general U.S. general population and utilized 39% the
aPAD for children 1 to 2 years old, the most highly exposed population
subgroup. The chronic dietary (food and drinking water) risk estimates
utilized 29% of the cPAD for the U.S. population and utilized 68% of
the cPAD for children 1 to 2 years old, the group with the highest
exposed population subgroup.
The aggregate exposure assessment for flupyradifurone is based on
food and drinking water as well as residential uses. Neither
intermediate- nor long-term (chronic) residential exposures are
expected, so only a short-term aggregate assessment was conducted.
Aggregate short-term residential exposure to adults and children
(residential exposures to handlers and post-application exposures to
adults and children) with the chronic (background) dietary exposure
yields margins of exposure MOEs of 300 for adults and 220 for
children); neither is of concern because EPA considers MOEs of less
than 100 to be of concern for aggregate risk.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the U.S. general population, or to infants and children from
aggregate exposure to flupyradifurone residues. More detailed
information on the subject action to establish time-limited tolerances
in or on sugarcane, cane and sugarcane, molasses can be found at http://www.regulations.gov in the document entitled ``Flupyradifurone: Human
Health Risk Assessment for Section 18 Emergency Exemption Request for
Use on Sugarcane in Louisiana.'' This document can be found in docket
ID number EPA-HQ-OPP-2020-0478.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (Method RV-001-P10-03) is
available to enforce the tolerance expression. This method uses high-
performance liquid chromatography
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with tandem mass spectrometry [HPLC/MS/MS) to quantitate residues of
flupyradifurone in various crops is available for enforcement.
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
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 Alimentarius 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.
There are no Codex and Canadian MRLs established on sugarcane.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
flupyradifurone in or on sugarcane, cane at 3 ppm and sugarcane,
molasses at 90 ppm. These tolerances expire on December 31, 2023.
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), 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,
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 directly 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, 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: April 20, 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. 180.679, amend paragraph (b) by:
0
a. Revising the introductory text; and
0
b. Adding in alphabetical order to the table the entries ``Sugarcane,
cane'' and ``Sugarcane, molasses''.
The revision and additions read as follows:
Sec. 180.679 Flupyradifurone; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide flupyradifurone, including
its metabolites and degradates in or on the specified agricultural
commodities listed in table 2 to this paragraph (b), resulting from use
of the pesticide pursuant to a Federal Insecticide, Fungicide, and
Rodenticide Act (FFIFRA) section 18 emergency exemption. Compliance
with the tolerance levels specified in table 2 to this paragraph (b) is
to be determined by measuring only flupyradifurone, 4-[[(6-chloro-3-
pyridinyl)methyl](2,2-difluoroethyl)amino]-2(5H)-furanone. The
tolerances expire on the date specified in table 2 to this paragraph
(b).
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Table 2 to Paragraph (b)
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Parts per Expiration
Commodity million date
------------------------------------------------------------------------
* * * * * * *
Sugarcane, cane......................... 3 12/31/2023
Sugarcane, molasses..................... 90 12/31/2023
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2021-08598 Filed 4-23-21; 8:45 am]
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