Glufosinate; Pesticide Tolerances, 39776-39780 [2023-12926]
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TABLE 1 TO PARAGRAPH (a)—Continued
Parts per
million
Commodity
Sheep, meat byproducts ..........................................................................................................................................................................
Soybean, forage ......................................................................................................................................................................................
Soybean, hay ...........................................................................................................................................................................................
Soybean, seed .........................................................................................................................................................................................
Spice group 26 ........................................................................................................................................................................................
Star apple ................................................................................................................................................................................................
Tea, dried 3 ..............................................................................................................................................................................................
Tea, instant 3 ............................................................................................................................................................................................
Tropical and subtropical, small fruit, edible peel, subgroup 23A 4 ..........................................................................................................
Vegetable, Brassica, head and stem, group 5–16 ..................................................................................................................................
Vegetable, cucurbit, group 9 ...................................................................................................................................................................
Vegetable, fruiting, group 8–10 ...............................................................................................................................................................
Vegetable, legume, bean, edible podded, subgroup 6–22A ...................................................................................................................
Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E ...............................................................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F ............................................................................................................
Vegetable, root, except sugar beet, subgroup 1B ..................................................................................................................................
Vegetable, tuberous and corm, subgroup 1C .........................................................................................................................................
Wheat, bran .............................................................................................................................................................................................
Wheat, forage ..........................................................................................................................................................................................
Wheat, grain ............................................................................................................................................................................................
Wheat, hay ...............................................................................................................................................................................................
Wheat, straw ............................................................................................................................................................................................
1 There
are
are
3 There are
4 There are
2 There
*
*
no
no
no
no
U.S.
U.S.
U.S.
U.S.
*
*
registrations
registrations
registrations
registrations
as of September 27, 1999, for use on banana.
as of January 18, 2012, for use on coffee, green bean.
as of June 24, 2019, for use on tea.
on this commodity as of January 11, 2022.
Unit I.C. of the SUPPLEMENTARY
*
[FR Doc. 2023–13023 Filed 6–16–23; 8:45 am]
INFORMATION).
BILLING CODE 6560–50–P
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0014; FRL–11019–01–
OCSPP]
Glufosinate; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of glufosinate in
or on tropical and subtropical, medium
to large fruit, edible peel, subgroup 23B;
tropical and subtropical, medium to
large fruit, smooth, inedible peel,
subgroup 24B; and tropical and
subtropical, small fruit, inedible peel,
subgroup 24A. The regulation also
establishes tolerances with regional
registrations in or on grass, forage and
grass, hay. The Interregional Project
Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective June
20, 2023. Objections and requests for
hearings must be received on or before
August 21, 2023, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
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SUMMARY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0014, is
available online at https://
www.regulations.gov or in-person 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 the OPP
Docket is (202) 566–1744.
For the latest status information on
EPA/DC services, docket access, visit
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
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
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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 Federal Register Office’s e-CFR site
at https://www.ecfr.gov/current/title=40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), 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–2022–0014 in the subject line on
the first page of your submission. All
objections and requests for a hearing
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must be in writing and must be received
by the Hearing Clerk on or before
August 21, 2023. 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–
2022–0014, by one of the following
methods:
• Federal eRulemaking Portal: https://
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.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerances
In the Federal Register of October 24,
2022 (87 FR 64196) (FRL–9410–06–
OCSPP), 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 1E8960) by
IR–4, North Carolina State University,
1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.473 be
amended to establish tolerances for
residues of the herbicide glufosinate
ammonium, determined by measuring
the sum of glufosinate ammonium,
butanoic acid, 2-amino-4(hydroxymethylphosphinyl)
monoammonium salt, and its
metabolites, 2-(acetylamino)-4(hydroxymethyl phosphinyl)butanoic
acid, and 3-(hydroxymethylphosphinyl)
propanoic acid, expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic
acid equivalents in or on the following
raw agricultural commodities: tropical
and subtropical, medium to large fruit,
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edible peel, subgroup 23B at 0.07 parts
per million (ppm); tropical and
subtropical, medium to large fruit,
smooth, inedible peel, subgroup 24B at
0.2 ppm; and tropical and subtropical,
small fruit, inedible peel, subgroup 24A
at 0.03 ppm. The petition also requested
that 40 CFR 180.473 be amended to
establish tolerances with regional
registrations for residues of glufosinate
ammonium in or on grass, forage at 0.15
ppm; and grass, hay at 0.2 ppm. Upon
the establishment of those tolerances,
the petition also requested that EPA
remove the following tolerances from 40
CFR 180.473: avocado at 0.03 ppm;
banana at 0.30 ppm; banana, pulp at
0.20 ppm; and fig at 0.07 ppm. The
Notice of Filing referenced a summary
of the petition prepared by IR–4, which
is available in the docket at https://
regulations.gov. No comments were
received in response to the Notice of
Filing.
Based upon review of the data
supporting the petition, EPA is
establishing two tolerances at a different
level than the petitioner requested. In
addition, EPA is establishing tolerances
for glufosinate rather than glufosinate
ammonium. The reasons for these
changes are 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
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 for glufosinate
including exposure resulting from the
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tolerances established by this action.
EPA’s assessment of exposures and risks
associated with glufosinate follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections that
repeat what has been previously
published in tolerance rulemakings for
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
considered in making its safety
determination for the new rulemaking.
EPA has previously published tolerance
rulemakings for glufosinate in which
EPA concluded, based on the available
information, that there is a reasonable
certainty that no harm would result
from aggregate exposure to glufosinate
and established tolerances for residues
of that chemical. In this rulemaking,
EPA is incorporating previously
published sections from the September
21, 2022, rulemaking (87 FR 57621)
(FRL–9521–01–OCSPP) as described
further below, as they remain
unchanged.
Toxicological Profile. For a discussion
of the Toxicological Profile of
glufosinate, see Unit III.A. of the
September 21, 2022, rulemaking.
Toxicological Points of Departure/
Levels of Concern. For a summary of the
Toxicological Points of Departure/
Levels of Concern used for the human
risk assessment, see Unit III.B. of the
September 21, 2022, rulemaking and
pages 12–13 of the document titled
‘‘Glufosinate. Human Health Risk
Assessment for Proposed New Use on
tropical and subtropical, medium to
large fruit, edible peel, subgroup 23B;
tropical and subtropical, medium to
large fruit, smooth, inedible peel,
subgroup 24B; tropical and subtropical,
small fruit, inedible peel, subgroup 24A;
and a new regional use on grass (seed
crop)’’ (hereinafter ‘‘Glufosinate Human
Health Risk Assessment’’) in docket ID
number EPA–HQ–OPP–2022–0014.
Exposure Assessment. Much of the
exposure assessment remains the same,
although updates have occurred to
account for 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, please reference
Unit III.C. of the September 21, 2022,
rulemaking.
EPA’s dietary exposure assessments
have been updated to include the
additional exposures from the new uses
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of glufosinate on tropical and
subtropical, medium to large fruit,
edible peel, subgroup 23B; tropical and
subtropical, medium to large fruit,
smooth, inedible peel, subgroup 24B;
and tropical and subtropical, small fruit,
inedible peel, subgroup 24A; and a new
regional use on grass (forage and hay).
In conducting the acute dietary
exposure assessment, EPA used the
Dietary Exposure Evaluation Model
software with the Food and Commodity
Intake Database (DEEM–FCID) Version
4.02. This software uses the 2005–2010
food consumption data from the U.S.
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEIA). The acute
dietary exposure assessment is
unrefined, assuming tolerance level
residues and 100 percent crop treated
(PCT) for all crop and livestock
commodities.
The chronic dietary exposure
assessment also uses the DEEM–FCID
Version 4.02 software with the
NHANES/WWEIA data. The chronic
dietary exposure assessment is refined
and uses the same assumptions as Unit
III.C.1.ii. in the September 21, 2022,
rulemaking; specifically, anticipated
residues based on average field trial
residue levels for plant raw agricultural
commodities, PCT information where
available, and experimentally
determined processing factors where
available. Anticipated residues for
livestock commodities were also
calculated and incorporated into the
assessment.
Anticipated residue and PCT
information. For a discussion of the
FFDCA requirements regarding use of
anticipated residue and PCT
information and the PCT assumptions
used in the chronic dietary exposure
assessment, see Unit III.C.1.iv. of the
September 21, 2022, rulemaking.
Drinking Water Exposure. The new
uses do not result in an increase in the
estimated residue levels in drinking
water, so EPA used the same estimated
drinking water concentrations in the
acute and chronic dietary exposure
assessments as identified in Unit III.C.2.
of the September 21, 2022, rulemaking.
Non-Occupational Exposure. There
are no new proposed residential (nonoccupational) uses for glufosinate at this
time; however, glufosinate is currently
registered for uses that could result in
residential handler and post-application
exposures, including use on lawn and
turf as well as recreational sites such as
golf courses. For a summary of those
exposures, see Unit III.C.3. of the
September 21, 2022, rulemaking.
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Cumulative Exposure. 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
glufosinate and any other substances,
and glufosinate does not appear to
produce a toxic metabolite produced by
other substances. For purposes of this
tolerance action, therefore, EPA has not
assumed that glufosinate has a common
mechanism of toxicity with other
substances.
Safety Factor for Infants and
Children. EPA continues to conclude
that there are reliable data to support
the reduction of the Food Quality
Protection Act (FQPA) safety factor to
1X for acute dietary exposure. For all
other exposure scenarios, EPA is
retaining a 10X FQPA safety factor. See
Unit III.D. of the September 21, 2022,
rulemaking for a discussion of the
Agency’s rationale for that
determination.
Aggregate Risk 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
population adjusted dose (cPAD).
Short-, intermediate-, and chronic term
aggregate risks are evaluated by
comparing the estimated total food,
water, and residential exposure to the
appropriate points of departure to
ensure that an adequate margin of
exposure (MOE) exists.
Acute dietary risks are below the
Agency’s level of concern of 100% of
the aPAD; they are 26% of the aPAD for
females 13–49 years old, the only
population subgroup for which an acute
toxic effect was identified. Chronic
dietary risks are below the Agency’s
level of concern of 100% of the cPAD;
they are 66% of the cPAD for all infants,
the most highly exposed population
subgroup.
The short-term aggregate exposure
assessment includes dietary (food and
drinking water) and dermal exposure
from high contact lawn activity on
treated lawns for adults and dermal plus
incidental oral exposure from high
contact lawn activity on treated lawns
for children 1 to less than 2 years old.
The short-term aggregate MOE for adults
is 4,600 and is not of concern because
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it is equal to or greater than the
Agency’s level of concern of 1,000. The
short-term aggregate MOE for children 1
to less than 2 years old is 1,000. This is
also not of concern because an MOE
equal to or greater than the level of
concern of 1,000 is not of concern.
Glufosinate is classified as ‘‘Not
Likely To Be Carcinogenic to Humans’’
based on the lack of evidence of a
treatment-related increase in tumors in
two adequate rodent carcinogenicity
studies.
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 glufosinate residues. More
detailed information on this action can
be found in the Glufosinate Human
Health Risk Assessment in docket ID
EPA–HQ–OPP–2022–0014.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method for
various crops, see Unit IV.A. of the
September 21, 2022, 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 U.S. tolerance for glufosinate
residues in or on tropical and
subtropical, medium to large fruit,
edible peel, subgroup 23B is
harmonized with the corresponding
Codex MRL at 0.1 ppm and the U.S.
tolerance for glufosinate residues in or
on tropical and subtropical, small fruit,
inedible peel, subgroup 24A is
harmonized with the corresponding
Codex MRL at 0.1 ppm. Additionally,
the U.S. tolerance for glufosinate
residues in or on tropical and
subtropical, medium to large fruit,
smooth, inedible peel, subgroup 24B is
harmonized with the established Codex
MRLs for banana and plantain at 0.2
ppm. The Codex MRLs for the other
commodities in subgroup 24B are at 0.1
ppm. It is not possible to harmonize
with the lower Codex MRLs for these
commodities because doing so would
put U.S. growers at risk of having
violative residues despite legal use of
the pesticide according to the label.
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There are no Codex MRLs for grass
commodities.
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C. Revisions to Petitioned-For
Tolerances
A tolerance of 0.1 ppm is being
established for tropical and subtropical,
medium to large fruit, edible peel,
subgroup 23B rather than 0.07 ppm as
requested. A tolerance of 0.1 ppm is
being established for tropical and
subtropical, small fruit, inedible peel,
subgroup 24A rather than 0.03 ppm as
requested. EPA is establishing these
tolerances at different levels than
requested to harmonize with the Codex
MRL.
In addition, EPA is establishing
tolerances for glufosinate, rather than
glufosinate ammonium as requested. As
explained in Unit III.V. of the
September 21, 2022, rulemaking, EPA
revised the tolerance expressions for
glufosinate in 40 CFR 180.473 to clarify
that the tolerance for the active
ingredient will be referred to as
glufosinate (i.e., the racemic mixture).
Glufosinate is a racemic mixture of the
D- and L-enantiomers, with the Lenantiomer being responsible for its
herbicidal activity. Glufosinate can exist
in multiple forms, including the acid,
ammonium, and sodium forms; other
salt forms of glufosinate may be possible
as well. While there are presently only
registrations for the ammonium form of
glufosinate, future registration requests
may be submitted for the acid, sodium,
or other forms. The tolerances for
glufosinate established in this action
would cover all these forms.
D. International Trade Considerations
In this rule, EPA is establishing a
tolerance for glufosinate residues in or
on tropical and subtropical, medium to
large fruit, smooth, inedible peel,
subgroup 24B at 0.2 ppm, which is
lower than the established tolerance for
banana at 0.30 ppm. The subgroup 24B
tolerance of 0.2 ppm is supported by
residue data provided by the petitioner
at a new proposed use pattern/rate that
is different than the use pattern/rate that
supported the established tolerance of
0.30 ppm.
In accordance with the World Trade
Organization’s (WTO) Sanitary and
Phytosanitary Measures (SPS)
Agreement, EPA intends to notify the
WTO of the changes to these tolerances
in order to satisfy its obligations under
the Agreement. In addition, the SPS
Agreement requires that Members
provide a ‘‘reasonable interval’’ between
the publication of a regulation subject to
the Agreement and its entry into force
to allow time for producers in exporting
Member countries to adapt to the new
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requirement. Accordingly, EPA is
establishing an expiration date for the
existing banana tolerances to allow this
tolerance to remain in effect for a period
of six months after the effective date of
this final rule. At the end of the sixmonth period, the banana tolerance will
expire, as indicated in the regulatory
text, and residues on banana must
conform to the tolerance for tropical and
subtropical, medium to large fruit,
smooth, inedible peel, subgroup 24B.
This reduction in tolerance level is not
discriminatory; the same food safety
standard contained in the FFDCA
applies equally to domestically
produced and imported foods. The new
tolerance level is supported by available
residue data.
V. Conclusion
Therefore, tolerances are established
for residues of glufosinate, (2-amino-4(hydroxymethylphosphinyl)butanoic
acid) and its metabolites, 2(acetylamino)-4-(hydroxymethyl
phosphinyl) butanoic acid, and 3(hydroxymethylphosphinyl) propanoic
acid, expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic
acid equivalents, in or on tropical and
subtropical, medium to large fruit,
edible peel, subgroup 23B at 0.1 ppm;
tropical and subtropical, medium to
large fruit, smooth, inedible peel,
subgroup 24B at 0.2 ppm; and tropical
and subtropical, small fruit, inedible
peel, subgroup 24A at 0.1 ppm.
Tolerances with regional registrations
are being established for residues of
glufosinate in or on grass, forage at 0.15
ppm; and grass, hay at 0.2 ppm.
Tolerances are also removed for the
following commodities due to the
establishment of tolerances for the
above commodities: avocado at 0.1 ppm;
banana at 0.30 ppm, which will expire
six months after the effective date of this
final rule, as explained above; banana,
pulp at 0.20 ppm; and fig at 0.1 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
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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 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, 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
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Federal Register / Vol. 88, No. 117 / Tuesday, June 20, 2023 / Rules and Regulations
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).
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 13, 2023.
Charles Smith,
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 § 180.473:
a. Amend Table 1 to Paragraph (a) by:
i. Removing the entry for ‘‘Avocado’’;
ii. Revising the entry for ‘‘Banana’’;
iii. Removing the entries for ‘‘Banana,
pulp’’ and ‘‘Fig’’; and
■ iv. Adding in alphabetical order the
entries ‘‘Tropical and subtropical,
medium to large fruit, edible peel,
subgroup 23B’’; ‘‘Tropical and
subtropical, medium to large fruit,
■
■
■
■
■
smooth, inedible peel, subgroup 24B’’;
and ‘‘Tropical and subtropical, small
fruit, inedible peel, subgroup 24A’’;
■ b. Revising paragraph (c); and
■ c. Amending paragraph (d) by
designating the table as table 3.
The additions and revisions read as
follows:
§ 180.473 Glufosinate; tolerances for
residues.
(a) * * *
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
*
Banana 1 ..............................................................................................................................................................................................
*
*
*
*
*
*
*
Tropical and subtropical, medium to large fruit, edible peel, subgroup 23B ......................................................................................
Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B ......................................................................
*
*
*
*
*
*
*
Tropical and subtropical, small fruit, inedible peel, subgroup 24A .....................................................................................................
*
*
1 This
*
*
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registrations are established for residues
of glufosinate, including its metabolites
and degradates, in or on the
commodities in the following table.
Compliance with the tolerance levels
specified in the following table is to be
determined by measuring the sum of
glufosinate, (2-amino-4(hydroxymethylphosphinyl)butanoic
acid) and its metabolites, 2(acetylamino)-4-(hydroxymethyl
phosphinyl) butanoic acid, and 3(hydroxymethylphosphinyl) propanoic
acid, expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic
acid equivalents.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0853; FRL–10967–01–
OCSPP]
Sulfoxaflor; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of sulfoxaflor in
or on coffee, green bean. Corteva
Agriscience requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective June
20, 2023. Objections and requests for
TABLE 2 TO PARAGRAPH (c)
hearings must be received on or before
Parts
per
August 21, 2023, and must be filed in
Commodity
million
accordance with the instructions
provided in 40 CFR part 178 (see also
Grass, forage ..............................
0.15
Unit I.C. of the SUPPLEMENTARY
Grass, hay ..................................
0.2
INFORMATION).
*
*
*
0.1
0.2
0.1
*
tolerance expires on December 20, 2023.
*
lotter on DSK11XQN23PROD with RULES1
*
0.30
*
*
*
BILLING CODE 6560–50–P
15:47 Jun 16, 2023
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0853, is
ADDRESSES:
[FR Doc. 2023–12926 Filed 6–16–23; 8:45 am]
VerDate Sep<11>2014
SUMMARY:
Jkt 259001
PO 00000
Frm 00014
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available at https://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 and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
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
E:\FR\FM\20JNR1.SGM
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Agencies
[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Rules and Regulations]
[Pages 39776-39780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12926]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0014; FRL-11019-01-OCSPP]
Glufosinate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
glufosinate in or on tropical and subtropical, medium to large fruit,
edible peel, subgroup 23B; tropical and subtropical, medium to large
fruit, smooth, inedible peel, subgroup 24B; and tropical and
subtropical, small fruit, inedible peel, subgroup 24A. The regulation
also establishes tolerances with regional registrations in or on grass,
forage and grass, hay. The Interregional Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective June 20, 2023. Objections and
requests for hearings must be received on or before August 21, 2023,
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-2022-0014, is available online at
https://www.regulations.gov or in-person 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 the OPP Docket is (202) 566-
1744.
For the latest status information on EPA/DC services, docket
access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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 Federal Register
Office's e-CFR site at https://www.ecfr.gov/current/title=40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2022-0014 in the subject line on the first
page of your submission. All objections and requests for a hearing
[[Page 39777]]
must be in writing and must be received by the Hearing Clerk on or
before August 21, 2023. 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-2022-0014, by one of
the following methods:
Federal eRulemaking Portal: https://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.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerances
In the Federal Register of October 24, 2022 (87 FR 64196) (FRL-
9410-06-OCSPP), 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 1E8960) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.473 be amended to establish tolerances for
residues of the herbicide glufosinate ammonium, determined by measuring
the sum of glufosinate ammonium, butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl) monoammonium salt, and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl)butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents in or on the
following raw agricultural commodities: tropical and subtropical,
medium to large fruit, edible peel, subgroup 23B at 0.07 parts per
million (ppm); tropical and subtropical, medium to large fruit, smooth,
inedible peel, subgroup 24B at 0.2 ppm; and tropical and subtropical,
small fruit, inedible peel, subgroup 24A at 0.03 ppm. The petition also
requested that 40 CFR 180.473 be amended to establish tolerances with
regional registrations for residues of glufosinate ammonium in or on
grass, forage at 0.15 ppm; and grass, hay at 0.2 ppm. Upon the
establishment of those tolerances, the petition also requested that EPA
remove the following tolerances from 40 CFR 180.473: avocado at 0.03
ppm; banana at 0.30 ppm; banana, pulp at 0.20 ppm; and fig at 0.07 ppm.
The Notice of Filing referenced a summary of the petition prepared by
IR-4, which is available in the docket at https://regulations.gov. No
comments were received in response to the Notice of Filing.
Based upon review of the data supporting the petition, EPA is
establishing two tolerances at a different level than the petitioner
requested. In addition, EPA is establishing tolerances for glufosinate
rather than glufosinate ammonium. The reasons for these changes are
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 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 for glufosinate including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with glufosinate follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published in tolerance rulemakings for 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
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for glufosinate in
which EPA concluded, based on the available information, that there is
a reasonable certainty that no harm would result from aggregate
exposure to glufosinate and established tolerances for residues of that
chemical. In this rulemaking, EPA is incorporating previously published
sections from the September 21, 2022, rulemaking (87 FR 57621) (FRL-
9521-01-OCSPP) as described further below, as they remain unchanged.
Toxicological Profile. For a discussion of the Toxicological
Profile of glufosinate, see Unit III.A. of the September 21, 2022,
rulemaking.
Toxicological Points of Departure/Levels of Concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
human risk assessment, see Unit III.B. of the September 21, 2022,
rulemaking and pages 12-13 of the document titled ``Glufosinate. Human
Health Risk Assessment for Proposed New Use on tropical and
subtropical, medium to large fruit, edible peel, subgroup 23B; tropical
and subtropical, medium to large fruit, smooth, inedible peel, subgroup
24B; tropical and subtropical, small fruit, inedible peel, subgroup
24A; and a new regional use on grass (seed crop)'' (hereinafter
``Glufosinate Human Health Risk Assessment'') in docket ID number EPA-
HQ-OPP-2022-0014.
Exposure Assessment. Much of the exposure assessment remains the
same, although updates have occurred to account for 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, please reference Unit III.C. of the
September 21, 2022, rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposures from the new uses
[[Page 39778]]
of glufosinate on tropical and subtropical, medium to large fruit,
edible peel, subgroup 23B; tropical and subtropical, medium to large
fruit, smooth, inedible peel, subgroup 24B; and tropical and
subtropical, small fruit, inedible peel, subgroup 24A; and a new
regional use on grass (forage and hay). In conducting the acute dietary
exposure assessment, EPA used the Dietary Exposure Evaluation Model
software with the Food and Commodity Intake Database (DEEM-FCID)
Version 4.02. This software uses the 2005-2010 food consumption data
from the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA).
The acute dietary exposure assessment is unrefined, assuming tolerance
level residues and 100 percent crop treated (PCT) for all crop and
livestock commodities.
The chronic dietary exposure assessment also uses the DEEM-FCID
Version 4.02 software with the NHANES/WWEIA data. The chronic dietary
exposure assessment is refined and uses the same assumptions as Unit
III.C.1.ii. in the September 21, 2022, rulemaking; specifically,
anticipated residues based on average field trial residue levels for
plant raw agricultural commodities, PCT information where available,
and experimentally determined processing factors where available.
Anticipated residues for livestock commodities were also calculated and
incorporated into the assessment.
Anticipated residue and PCT information. For a discussion of the
FFDCA requirements regarding use of anticipated residue and PCT
information and the PCT assumptions used in the chronic dietary
exposure assessment, see Unit III.C.1.iv. of the September 21, 2022,
rulemaking.
Drinking Water Exposure. The new uses do not result in an increase
in the estimated residue levels in drinking water, so EPA used the same
estimated drinking water concentrations in the acute and chronic
dietary exposure assessments as identified in Unit III.C.2. of the
September 21, 2022, rulemaking.
Non-Occupational Exposure. There are no new proposed residential
(non-occupational) uses for glufosinate at this time; however,
glufosinate is currently registered for uses that could result in
residential handler and post-application exposures, including use on
lawn and turf as well as recreational sites such as golf courses. For a
summary of those exposures, see Unit III.C.3. of the September 21,
2022, rulemaking.
Cumulative Exposure. 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.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to glufosinate and any other substances, and
glufosinate does not appear to produce a toxic metabolite produced by
other substances. For purposes of this tolerance action, therefore, EPA
has not assumed that glufosinate has a common mechanism of toxicity
with other substances.
Safety Factor for Infants and Children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor to 1X for acute dietary
exposure. For all other exposure scenarios, EPA is retaining a 10X FQPA
safety factor. See Unit III.D. of the September 21, 2022, rulemaking
for a discussion of the Agency's rationale for that determination.
Aggregate Risk 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 population adjusted dose (cPAD). Short-, intermediate-,
and chronic term aggregate risks are evaluated by comparing the
estimated total food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 26% of the aPAD for females 13-49 years old, the
only population subgroup for which an acute toxic effect was
identified. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD; they are 66% of the cPAD for all infants,
the most highly exposed population subgroup.
The short-term aggregate exposure assessment includes dietary (food
and drinking water) and dermal exposure from high contact lawn activity
on treated lawns for adults and dermal plus incidental oral exposure
from high contact lawn activity on treated lawns for children 1 to less
than 2 years old. The short-term aggregate MOE for adults is 4,600 and
is not of concern because it is equal to or greater than the Agency's
level of concern of 1,000. The short-term aggregate MOE for children 1
to less than 2 years old is 1,000. This is also not of concern because
an MOE equal to or greater than the level of concern of 1,000 is not of
concern.
Glufosinate is classified as ``Not Likely To Be Carcinogenic to
Humans'' based on the lack of evidence of a treatment-related increase
in tumors in two adequate rodent carcinogenicity studies.
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 glufosinate residues. More detailed information
on this action can be found in the Glufosinate Human Health Risk
Assessment in docket ID EPA-HQ-OPP-2022-0014.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method for
various crops, see Unit IV.A. of the September 21, 2022, 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 U.S. tolerance for glufosinate residues in or on tropical and
subtropical, medium to large fruit, edible peel, subgroup 23B is
harmonized with the corresponding Codex MRL at 0.1 ppm and the U.S.
tolerance for glufosinate residues in or on tropical and subtropical,
small fruit, inedible peel, subgroup 24A is harmonized with the
corresponding Codex MRL at 0.1 ppm. Additionally, the U.S. tolerance
for glufosinate residues in or on tropical and subtropical, medium to
large fruit, smooth, inedible peel, subgroup 24B is harmonized with the
established Codex MRLs for banana and plantain at 0.2 ppm. The Codex
MRLs for the other commodities in subgroup 24B are at 0.1 ppm. It is
not possible to harmonize with the lower Codex MRLs for these
commodities because doing so would put U.S. growers at risk of having
violative residues despite legal use of the pesticide according to the
label.
[[Page 39779]]
There are no Codex MRLs for grass commodities.
C. Revisions to Petitioned-For Tolerances
A tolerance of 0.1 ppm is being established for tropical and
subtropical, medium to large fruit, edible peel, subgroup 23B rather
than 0.07 ppm as requested. A tolerance of 0.1 ppm is being established
for tropical and subtropical, small fruit, inedible peel, subgroup 24A
rather than 0.03 ppm as requested. EPA is establishing these tolerances
at different levels than requested to harmonize with the Codex MRL.
In addition, EPA is establishing tolerances for glufosinate, rather
than glufosinate ammonium as requested. As explained in Unit III.V. of
the September 21, 2022, rulemaking, EPA revised the tolerance
expressions for glufosinate in 40 CFR 180.473 to clarify that the
tolerance for the active ingredient will be referred to as glufosinate
(i.e., the racemic mixture). Glufosinate is a racemic mixture of the D-
and L-enantiomers, with the L-enantiomer being responsible for its
herbicidal activity. Glufosinate can exist in multiple forms, including
the acid, ammonium, and sodium forms; other salt forms of glufosinate
may be possible as well. While there are presently only registrations
for the ammonium form of glufosinate, future registration requests may
be submitted for the acid, sodium, or other forms. The tolerances for
glufosinate established in this action would cover all these forms.
D. International Trade Considerations
In this rule, EPA is establishing a tolerance for glufosinate
residues in or on tropical and subtropical, medium to large fruit,
smooth, inedible peel, subgroup 24B at 0.2 ppm, which is lower than the
established tolerance for banana at 0.30 ppm. The subgroup 24B
tolerance of 0.2 ppm is supported by residue data provided by the
petitioner at a new proposed use pattern/rate that is different than
the use pattern/rate that supported the established tolerance of 0.30
ppm.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of the changes to these tolerances in order to satisfy its
obligations under the Agreement. In addition, the SPS Agreement
requires that Members provide a ``reasonable interval'' between the
publication of a regulation subject to the Agreement and its entry into
force to allow time for producers in exporting Member countries to
adapt to the new requirement. Accordingly, EPA is establishing an
expiration date for the existing banana tolerances to allow this
tolerance to remain in effect for a period of six months after the
effective date of this final rule. At the end of the six-month period,
the banana tolerance will expire, as indicated in the regulatory text,
and residues on banana must conform to the tolerance for tropical and
subtropical, medium to large fruit, smooth, inedible peel, subgroup
24B. This reduction in tolerance level is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance level is
supported by available residue data.
V. Conclusion
Therefore, tolerances are established for residues of glufosinate,
(2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites,
2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents, in or on tropical
and subtropical, medium to large fruit, edible peel, subgroup 23B at
0.1 ppm; tropical and subtropical, medium to large fruit, smooth,
inedible peel, subgroup 24B at 0.2 ppm; and tropical and subtropical,
small fruit, inedible peel, subgroup 24A at 0.1 ppm. Tolerances with
regional registrations are being established for residues of
glufosinate in or on grass, forage at 0.15 ppm; and grass, hay at 0.2
ppm.
Tolerances are also removed for the following commodities due to
the establishment of tolerances for the above commodities: avocado at
0.1 ppm; banana at 0.30 ppm, which will expire six months after the
effective date of this final rule, as explained above; banana, pulp at
0.20 ppm; and fig at 0.1 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive 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 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, 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
[[Page 39780]]
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: June 13, 2023.
Charles Smith,
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. 180.473:
0
a. Amend Table 1 to Paragraph (a) by:
0
i. Removing the entry for ``Avocado'';
0
ii. Revising the entry for ``Banana'';
0
iii. Removing the entries for ``Banana, pulp'' and ``Fig''; and
0
iv. Adding in alphabetical order the entries ``Tropical and
subtropical, medium to large fruit, edible peel, subgroup 23B'';
``Tropical and subtropical, medium to large fruit, smooth, inedible
peel, subgroup 24B''; and ``Tropical and subtropical, small fruit,
inedible peel, subgroup 24A'';
0
b. Revising paragraph (c); and
0
c. Amending paragraph (d) by designating the table as table 3.
The additions and revisions read as follows:
Sec. 180.473 Glufosinate; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Banana \1\.............................................. 0.30
* * * * * * *
Tropical and subtropical, medium to large fruit, edible 0.1
peel, subgroup 23B.....................................
Tropical and subtropical, medium to large fruit, smooth, 0.2
inedible peel, subgroup 24B............................
* * * * * * *
Tropical and subtropical, small fruit, inedible peel, 0.1
subgroup 24A...........................................
* * * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on December 20, 2023.
* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of glufosinate,
including its metabolites and degradates, in or on the commodities in
the following table. Compliance with the tolerance levels specified in
the following table is to be determined by measuring the sum of
glufosinate, (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its
metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic
acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-
amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents.
Table 2 to Paragraph (c)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grass, forage............................................... 0.15
Grass, hay.................................................. 0.2
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-12926 Filed 6-16-23; 8:45 am]
BILLING CODE 6560-50-P