Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (FY23Q4), 62492-62499 [2023-19513]
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Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Proposed Rules
comment period is now open through
November 13, 2023.
The comment period for the
supplemental notice of proposed
rulemaking published June 14, 2023, (88
FR 38765) is extended. Comments and
related material must be received by the
Coast Guard on or before November 13,
2023.
DATES:
You may submit comments
identified by docket number USCG–
2013–1057 using the Federal
eRulemaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
ADDRESSES:
For
information about this document call or
email LCDR Laura Fitzpatrick, Office of
Investigations and Casualty Analysis
(CG–INV), Coast Guard; telephone 202–
372–1032, email Laura.M.Fitzpatrick@
uscg.mil.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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Public Participation and Request for
Comments
The Coast Guard views public
participation as essential to effective
rulemaking, and will consider all
comments and material received during
the comment period. Your comment can
help shape the outcome of this
rulemaking. If you submit a comment,
please include the docket number for
this rulemaking, indicate the specific
section of this document to which each
comment applies, and provide a reason
for each suggestion or recommendation.
We encourage you to submit
comments through the Federal
eRulemaking Portal at
www.regulations.gov. If you cannot
submit your material by using
www.regulations.gov, call or email the
person in the FOR FURTHER INFORMATION
CONTACT section of this proposed rule
for alternate instructions. We review all
comments received, but we will only
post comments that address the topic of
the proposed rule. We may choose not
to post off-topic, inappropriate, or
duplicate comments that we receive.
We accept anonymous comments. All
comments we post to https://
www.regulations.gov will include any
personal information you have
provided. For more about privacy and
submissions in response to this
document, see the Department of
Homeland Security’s eRulemaking
System of Records notice (85 FR 14226,
March 11, 2020).
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Background and Discussion
The Coast Guard issued a
supplemental notice of proposed
rulemaking (SNPRM) entitled ‘‘Marine
Casualty Reporting on the Outer
Continental Shelf,’’ on June 14, 2023 (88
FR 38765). In it we propose changing
the reporting criteria for changing the
reporting criteria for certain casualties
that occur on foreign floating outer
continental shelf (OCS) facilities (FOFs),
mobile offshore drilling units (MODUs),
and vessels engaged in OCS activities.
In addition, the SNPRM proposes to
raise the property damage dollar
threshold that triggers a casualty report
from $25,000 to $75,000 for fixed
facilities on the OCS because the
original regulation setting the property
damage threshold amount was issued in
the 1980s and has not since been
updated. This SNPRM would update
Coast Guard regulations to keep up with
technology, improve awareness of
accident trends on the OCS, improve
safety on the OCS, and reduce the
regulatory burden on operators of fixed
OCS platforms.
We set a 90-day comment period for
the SNRPM and received several
requests to extend the comment period.
The requesters cited need for additional
time to provide constructive responses
to the SNRPM and a lack of awareness
about the SNPRM among members of
the affected industry as reasons for the
requested extension.
In response to this request, we
decided to extend the public comment
period by 60 days. The comment period
is now open through November 13,
2023.
Dated: September 8, 2023.
W.R. Arguin,
Rear Admiral, U.S. Coast Guard, Assistant
Commandant for Prevention Policy.
under the Federal Food, Drug, and
Cosmetic Act (FFDCA) that the Agency
determined were necessary or
appropriate during the registration
review conducted under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA). During registration review,
EPA reviews all aspects of a pesticide
case, including existing tolerances, to
ensure that the pesticide continues to
meet the standard for registration under
FIFRA. The tolerance actions and
pesticide active ingredients addressed
in this rulemaking are identified in Unit
I.B. and discussed in detail in Unit III.
of this document.
DATES: Comments must be received on
or before November 13, 2023.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2023–0254,
through the Federal eRulemaking Portal
at: https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Additional
instructions on commenting or visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Robert Little, Pesticide Re-Evaluation
Division (7508M), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 566–2234; email address:
little.robert@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
AGENCY:
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).
EPA is proposing to
implement several tolerance actions
B. What action is the Agency taking?
EPA is proposing several tolerance
actions that the Agency previously
determined were necessary or
[FR Doc. 2023–19811 Filed 9–11–23; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2023–0254; FRL–11283–01–
OCSPP]
RIN 2070–ZA16
Pesticide Tolerances; Implementing
Registration Review Decisions for
Certain Pesticides (FY23Q4)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY:
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appropriate during registration review
for the following pesticide active
ingredients: chlorsulfuron,
primisulfuron-methyl, triasulfuron,
halosulfuron-methyl, sulfosulfuron,
iodosulfuron-methyl-sodium,
trifloxysulfuron-sodium, and
mesosulfuron-methyl. The proposed
tolerance actions for each pesticide
active ingredient are described in Unit
III. and may include but are not limited
to the following types of actions:
• Revising tolerance expressions;
• Modifying commodity definitions;
• Updating crop groups;
• Removing expired tolerances;
• Revoking tolerances that are no
longer needed; and
• Harmonizing tolerances with Codex
Maximum Residue Levels (MRLs).
Although they may not have been
identified in the registration review of a
particular pesticide, this rule also
includes proposals to reflect the
Agency’s 2019 adoption of the
Organization of Economic Cooperation
and Development (OECD) Rounding
Class Practice. Where applicable, these
adjustments are proposed for specific
pesticides as reflected in the proposed
regulatory text section.
C. What is EPA’s authority for taking
this action?
Pursuant to its authority under the
Federal Food, Drug and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, EPA is
proposing the tolerance actions in this
rulemaking that the Agency previously
determined were necessary or
appropriate during the registration
review conducted under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), 7 U.S.C. 136 et seq.
FFDCA section 408(b) authorizes EPA
to establish a tolerance, if the Agency
determines that a tolerance is safe;
FFDCA section 408(c) authorizes EPA to
establish an exemption from the
requirement of a tolerance if the Agency
determines that the exemption is safe.
See 21 U.S.C. 346a(b) and (c). If EPA
determines that a tolerance or
exemption is not safe, EPA must modify
or revoke that tolerance or exemption.
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.’’ 21 U.S.C.
346a(b)(2)(A)(ii), (c)(2)(A)(ii). This
includes exposure through drinking
water and in residential settings but
does not include occupational exposure.
FFDCA section 408(b)(2)(C) requires
EPA to give special consideration to the
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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[s.]’’ 21
U.S.C. 346a(b)(2)(C). In addition,
FFDCA section 408(b)(2)(D) contains
several factors EPA must consider when
making determinations about
establishing, modifying, or revoking
tolerances. 21 U.S.C. 346a(b)(2)(D).
FFDCA section 408(c)(2)(B) requires that
EPA, when making determinations
about exemptions, to take into account,
among other things, the considerations
set forth in FFDCA section 408(b)(2)(C)
and (D). 21 U.S.C. 346a(c)(2)(B).
FFDCA section 408(e), 21 U.S.C.
346a(e), authorizes EPA to establish,
modify, or revoke tolerances or
exemptions from the requirement of a
tolerance on its own initiative. Prior to
issuing the final regulation, FFDCA
section 408(e)(2) requires EPA to issue
a notice of proposed rulemaking for a
60-day public comment period, unless
the Administrator for good cause finds
that it would be in the public interest to
have a shorter period and states the
reasons in the rulemaking.
Furthermore, when establishing
tolerances or exemptions from the
requirement of a tolerance, FFDCA
sections 408(b)(3) and (c)(3) require that
there be a practical method for detecting
and measuring pesticide chemical
residue levels in or on food, unless in
the case of exemptions, EPA determines
that such method is not needed and
states the reasons therefor in the
rulemaking. 21 U.S.C. 346a(b) and (c).
Under FIFRA section 3(g), 7 U.S.C.
136a(g), EPA is required to periodically
review all registered pesticides and
determine if those pesticides continue
to meet the standard for registration
under FIFRA. See also 40 CFR
155.40(a). Consistent with its
obligations under FIFRA section 3(g)
and FFDCA section 408, EPA has
reviewed the available scientific data
and other relevant information and
determined it is appropriate to take the
tolerance actions being proposed in this
rulemaking.
D. What can I do if I want the Agency
to maintain a tolerance that the Agency
proposes to revoke?
This proposed rule provides a 60-day
public comment period that allows any
person to state an interest in retaining
a tolerance proposed for revocation. If
EPA receives such a comment within
the 60-day period, EPA will not proceed
to revoke the tolerance immediately.
However, EPA will take steps to ensure
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the submission of any needed
supporting data and will issue an order
in the Federal Register under FFDCA
section 408(f), if needed. The order
would specify data needed and the
timeframes for submission of the data
and would require that within 90 days
some person or persons notify EPA that
they will submit the data. If the data are
not submitted as required in the order,
EPA will take appropriate action under
FFDCA.
After considering comments that are
received in response to this proposed
rule, EPA will issue a final rule. At the
time of the final rule, you may file an
objection or request a hearing on the
action taken in the final rule. If you fail
to file an objection to the final rule
within the time period specified in the
final rule, you will have waived the
right to raise any issues resolved in the
final rule. After the filing deadline
specified in the final rule, issues
resolved in the final rule cannot be
raised again in any subsequent
proceedings.
E. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through https://
www.regulations.gov or email. If you
wish to include CBI in your comment,
please follow the applicable instructions
at https://www.epa.gov/dockets/
commenting-epa-dockets#rules and
clearly mark the part or all of the
information that you claim to be CBI. In
addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.regulations.gov/faq.
3. Environmental justice. EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies.
II. Background
A. What is a tolerance?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on food,
which includes raw agricultural
commodities and processed foods and
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feed for animals. Under the FFDCA,
residues of a pesticide chemical that are
not covered by a tolerance or exemption
from the requirement of a tolerance are
considered unsafe. See 21 U.S.C.
346a(a)(1). Foods containing unsafe
residues are deemed adulterated and
may not be distributed in interstate
commerce. See 21 U.S.C. 331(a),
342(a)(2)(B). Consequently, for a fooduse pesticide (i.e., a pesticide use that is
likely to result in residues in or on food)
to be sold and distributed, the pesticide
must not only have appropriate
tolerances or exemptions under the
FFDCA, but also must be registered
under FIFRA, 7 U.S.C. 136 et seq. Fooduse pesticides not registered in the
United States must have tolerances or
exemptions in order for commodities
treated with those pesticides to be
imported into the United States. For
additional information about tolerances,
go to https://www.epa.gov/pesticidetolerances/about-pesticide-tolerances.
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B. Why does EPA consider international
residue limits?
When establishing a tolerance for
residues of a pesticide, EPA must
determine whether the Codex
Alimentarius Commission (Codex) has
established a Maximum Residue Limit
(MRL) for that pesticide. See 21 U.S.C.
346a(b)(4). As part of registration
review, EPA determines whether
international tolerances or MRLs exist
for commodities and chemicals for
which U.S. tolerances have been
established. Where appropriate, EPA’s
intention is to harmonize U.S.
tolerances with those international
MRLs to facilitate trade. EPA’s effort to
harmonize with Codex MRLs is
summarized in the tolerance
reassessment section of the individual
human health risk assessments that
support the pesticide registration
review.
C. What is pesticide registration review?
EPA periodically reviews existing
registered pesticides to ensure they can
continue to be used without
unreasonable adverse effects on human
health or the environment. The
registration review program is intended
to make sure that, as the ability to assess
risk evolves and as policies and
practices change, all registered
pesticides continue to meet the FIFRA
registration standard of no unreasonable
adverse effects. As part of the
registration review of a pesticide, EPA
also evaluates whether existing
tolerances are safe, whether any changes
to existing tolerances are necessary or
appropriate, and whether any new
tolerances are necessary to cover
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residues from registered pesticides.
Where appropriate, EPA has included a
safety finding under the FFDCA for the
proposed tolerance action for the
pesticide, which is discussed in detail
in the human health risk assessments
conducted to support the registration
review of each specific pesticide active
ingredient or registration review case. In
addition, these proposed tolerance
changes are summarized in both the
Proposed Interim Decision (PID), and in
the Interim Decision (ID) for each
pesticide active ingredient or
registration review case. These
documents can be found in the public
docket that has been opened for each
pesticide, which is available online at
https://www.regulations.gov, using the
docket ID number listed in Unit III. for
each pesticide active ingredient
included in this proposed action.
Additional information about pesticide
registration review is available at
https://www.epa.gov/pesticidereevaluation.
III. Proposed Tolerance Actions
EPA is proposing to take the specific
tolerance actions identified in this unit.
A. 40 CFR 180.405; Chlorsulfuron; Case
0631 (Docket ID No. EPA–HQ–OPP–
2012–0878)
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
• Revising the tolerance expression
for chlorsulfuron to describe more
clearly the scope or coverage of the
tolerances and the method for
measuring compliance. Consistent with
EPA policy, the revised tolerance
expression would clarify that (1) as
provided in FFDCA section 408(a)(3),
the tolerances cover metabolites and
degradates of chlorsulfuron not
specifically mentioned; and (2)
compliance with the specified tolerance
levels is to be determined by measuring
the specific compounds mentioned in
the tolerance expression. The revisions
to the tolerance expression would not
substantively change the tolerances or,
in any way, modify the permissible
level of residues permitted by the
tolerances.
• Merging the established tolerances
into a single paragraph for clarity.
• Modifying tolerance values or
tolerance levels for ‘‘Grass, forage’’;
‘‘Grass, hay’’; ‘‘Oat, forage’’; and
‘‘Wheat, forage’’ to reflect current OECD
rounding practices.
2. Safety Finding
During registration review, EPA
assessed the risks from exposure to
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chlorsulfuron, taking into consideration
all reliable data on toxicity and
exposure, including for infants and
children. Based on the supporting risk
assessments and registration review
documents, which demonstrate that the
aggregate exposure is below the
Agency’s level of concern, EPA
concludes there is a reasonable certainty
that no harm will result to the general
population, or specifically to infants
and children, from aggregate exposure
to chlorsulfuron residues. Thus, EPA
has determined that the tolerances for
residues of chlorsulfuron are safe.
Adequate enforcement methodology as
described in the supporting documents
is available to enforce the tolerance
expression. For further detail, see
Chlorsulfuron. Draft Human Health Risk
Assessment in Support of Registration
Review, which can be found in the
docket ID number listed in the heading
of this unit.
B. 40 CFR 180.452; Primisulfuronmethyl; Case 7220 (Docket ID No. EPA–
HQ–OPP–2011–0844)
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
• Revising the tolerance expression
for primisulfuron-methyl to describe
more clearly the scope or coverage of
the tolerances and the method for
measuring compliance. Consistent with
EPA policy, the revised tolerance
expression would clarify that (1) as
provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of primisulfuron-methyl not
specifically mentioned; and (2)
compliance with the specified tolerance
levels is to be determined by measuring
the specific compounds mentioned in
the tolerance expression. The revisions
to the tolerance expression would not
substantively change the tolerances or,
in any way, modify the permissible
level of residues permitted by the
tolerances.
2. Safety finding
EPA has determined that the
proposed change to the tolerance
expression would not impact EPA’s
previous safety findings for the
established tolerances for
primisulfuron-methyl, because the
change has no substantive effect on the
tolerances or supporting risk
assessments, but rather is merely
intended to clarify the existing tolerance
expression. For further detail, see
Primisulfuron-Methyl. Human Health
Draft Risk Assessment for Registration
Review, which can be found in the
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docket ID number listed in the heading
of this unit.
C. 40 CFR 180.459; Triasulfuron; Case
7221 (Docket ID No. EPA–HQ–OPP–
2012–0115)
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
• Revising the tolerance expression
for triasulfuron to describe more clearly
the scope or coverage of the tolerances
and the method for measuring
compliance. Consistent with EPA
policy, the revised tolerance expression
would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of
triasulfuron not specifically mentioned;
and (2) compliance with the specified
tolerance levels is to be determined by
measuring the specific compounds
mentioned in the tolerance expression.
The revisions to the tolerance
expression would not substantively
change the tolerances or, in any way,
modify the permissible level of residues
permitted by the tolerances.
2. Safety Finding
EPA has determined that the
proposed change to the tolerance
expression would not impact EPA’s
previous safety findings for the
established tolerances for triasulfuron,
because the change has no substantive
effect on the tolerances or supporting
risk assessments, but rather is merely
intended to clarify the existing tolerance
expression. For further detail, see
Triasulfuron. Draft Human Health Risk
Assessment in Support of Registration
Review, which can be found in the
docket ID number listed in the heading
of this unit.
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D. 40 CFR 180.479; Halosulfuronmethyl; Case 7233 (Docket ID No. EPA–
HQ–OPP–2011–0745)
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
• Modifying the tolerance level for
residues of halosulfuron-methyl in or on
asparagus from 0.8 ppm to 1 ppm to
harmonize with the Canadian MRL.
There are no Codex MRLs for this
pesticide chemical.
• Converting the existing crop group
tolerances for ‘‘vegetable, fruiting, group
8’’ and ‘‘nut, tree, crop group 14’’ to the
updated crop group tolerances for
‘‘vegetable, fruiting, group 8–10’’ and
‘‘nut, tree, crop group 14–12,’’
respectively. The tolerance levels would
remain the same. 40 CFR 180.40(j) states
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that ‘‘[a]t appropriate times, EPA will
amend tolerances for crop groups that
have been superseded by revised crop
groups to conform the pre-existing crop
group to the revised crop group.’’ EPA
has indicated in updates to its crop
group rulemakings that registration
review is one of those appropriate times.
See, e.g., Tolerance Crop Grouping
Program V (85 FR 70976) (November 6,
2020).
• Removing tolerances for residues of
halosulfuron-methyl in or on certain
commodities. Specifically, EPA is
proposing to remove the tolerance for
‘‘pea and bean, succulent shelled,
subgroup 6’’ because it is an incorrect
entry; no such crop subgroup exists.
Instead, these commodities are covered
under the established tolerance for ‘‘pea
and bean, succulent shelled, subgroup
6B’’ at the same tolerance level. In
addition, EPA proposes to remove
tolerances for okra and pistachio as
unnecessary, because they would be
covered by the updated crop group
tolerances for ‘‘vegetable, fruiting, group
8–10’’ and ‘‘nut, tree, crop group 14–
12,’’ respectively, at the same tolerance
levels.
2. Safety Finding
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• Revising the tolerance expression
for sulfosulfuron to describe more
clearly the scope or coverage of the
tolerances and the method for
measuring compliance. Consistent with
EPA policy, the revised tolerance
expression would clarify that (1) as
provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of sulfosulfuron not
specifically mentioned; and (2)
compliance with the specified tolerance
levels is to be determined by measuring
the specific compounds mentioned in
the tolerance expression. The revisions
to the tolerance expression do not
substantively change the tolerances or,
in any way, modify the permissible
level of residues permitted by the
tolerances.
• Removing the tolerances for
residues of sulfosulfuron in or on hog,
meat (0.005 ppm); hog, fat (0.005 ppm);
and hog, meat byproducts (0.05 ppm).
EPA has determined that there is no
reasonable expectation of finite residues
of concern in swine. See 40 CFR
180.6(a)(3). Moreover, a re-evaluation of
tolerance enforcement methods
determined that the limits of
quantitation for these methods is 0.01
ppm.
During registration review, EPA
assessed the risks from exposure to
halosulfuron-methyl, taking into
consideration all reliable data on
toxicity and exposure, including for
infants and children. Based on the
supporting risk assessments and
registration review documents, which
demonstrate that the aggregate exposure
is below the Agency’s level of concern,
EPA concludes there is a reasonable
certainty that no harm will result to the
general population, or specifically to
infants and children, from aggregate
exposure to halosulfuron-methyl
residues. Thus, EPA has determined
that the tolerances for residues of
halosulfuron-methyl are safe. Adequate
enforcement methodology as described
in the supporting documents is
available to enforce the tolerance
expression. For further detail, see
Halosulfuron-Methyl. Draft Human
Health Risk Assessment for Registration
Review, which can be found in the
docket ID number listed in the heading
of this unit.
2. Safety Finding
E. 40 CFR 180.552; Sulfosulfuron; Case
7247 (Docket ID No. EPA–HQ–OPP–
2011–0434)
F. 40 CFR 180.580; Iodosulfuron-methylsodium; Case 7253 (Docket ID No. EPA–
HQ–OPP–2012–0717)
1. Proposed Changes to the Current
Tolerances
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
EPA is proposing to amend the
current tolerances by:
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During registration review, EPA
assessed the risks from exposure to
sulfosulfuron, taking into consideration
all reliable data on toxicity and
exposure, including for infants and
children. Based on the supporting risk
assessments and registration review
documents, which demonstrate that the
aggregate exposure is below the
Agency’s level of concern, EPA
concludes there is a reasonable certainty
that no harm will result to the general
population, or specifically to infants
and children, from aggregate exposure
to sulfosulfuron residues. Thus, EPA
has determined that the tolerances for
residues of sulfosulfuron are safe.
Adequate enforcement methodology as
described in the supporting documents
is available to enforce the tolerance
expression. For further detail, see
Sulfosulfuron. Draft Human Health Risk
Assessment in Support of Registration
Review, which can be found in the
docket ID number listed in the heading
of this unit.
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• Revising the tolerance expression
for iodosulfuron-methyl-sodium to
describe more clearly the scope or
coverage of the tolerances and the
method for measuring compliance.
Consistent with EPA policy, the revised
tolerance expression would clarify that
(1) as provided in FFDCA section
408(a)(3), the tolerance covers
metabolites and degradates of
iodosulfuron-methyl-sodium not
specifically mentioned; and (2) that
compliance with the specified tolerance
levels is to be determined by measuring
the specific compounds mentioned in
the tolerance expression. The revisions
to the tolerance expression do not
substantively change the tolerances or,
in any way, modify the permissible
level of residues permitted by the
tolerances.
level of residues permitted by the
tolerances.
• Revoking tolerances for residues of
trifloxysulfuron in or on almond (0.02
ppm) and almond hulls (0.01 ppm).
Almonds are no longer included as a
use site on any trifloxysulfuron-sodium
product labels; therefore, the Agency is
proposing to revoke the established
tolerances. In addition, to allow a
reasonable interval for producers in
exporting members of the World Trade
Organization’s (WTO’s) Sanitary and
Phytosanitary (SPS) Measures
Agreement to adapt to these
requirements in the final rule, EPA is
proposing to amend the existing
tolerances to include an expiration date
that would be six months after the date
of publication of the final rule in the
Federal Register.
2. Safety Finding
2. Safety Finding
EPA has determined that the
proposed change to the tolerance
expression would not impact EPA’s
previous safety findings for the
established tolerances for iodosulfuronmethyl-sodium, because the change has
no substantive effect on the tolerances
or supporting risk assessments, but
rather is merely intended to clarify the
existing tolerance expression. For
further detail, see Iodosulfuron-MethylSodium. Draft Human Health Risk
Assessment in Support of Registration
Review, which can be found in the
docket ID number listed in the heading
of this unit.
During registration review, EPA
assessed the risks from exposure to
trifloxysulfuron-sodium, taking into
consideration all reliable data on
toxicity and exposure, including for
infants and children. Based on the
supporting risk assessments and
registration review documents, which
demonstrate that the aggregate exposure
is below the Agency’s level of concern,
EPA concludes there is a reasonable
certainty that no harm will result to the
general population, or specifically to
infants and children, from aggregate
exposure to trifloxysulfuron-sodium.
Thus, EPA has determined that the
tolerances for residues of
trifloxysulfuron, resulting from the
application of its sodium salt, are safe.
Adequate enforcement methodology as
described in the supporting documents
is available to enforce the tolerance
expression. For further detail, see
Trifloxysulfuron-Sodium. Draft Human
Health Risk Assessment in Support of
Registration Review, which can be
found in the docket ID number listed in
the heading of this unit
G. 40 CFR 180.591; Trifloxysulfuron;
Case 7028 (Docket ID No. EPA–HQ–
OPP–2013–0409)
lotter on DSK11XQN23PROD with PROPOSALS1
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
• Revising the tolerance expression
for trifloxysulfuron, resulting from the
application of its sodium salt, to
describe more clearly the scope or
coverage of the tolerances and the
method for measuring compliance.
Consistent with EPA policy, the revised
tolerance expression would clarify that
(1) as provided in FFDCA section
408(a)(3), the tolerance covers
metabolites and degradates of
trifloxysulfuron not specifically
mentioned; and (2) that compliance
with the specified tolerance levels is to
be determined by measuring the specific
compounds mentioned in the tolerance
expression. The revisions to the
tolerance expression do not
substantively change the tolerances or,
in any way, modify the permissible
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17:03 Sep 11, 2023
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H. 40 CFR 180.597; MesosulfuronMethyl; Case 7277 (Docket ID No. EPA–
HQ–OPP–2012–0833)
1. Proposed Changes to the Current
Tolerances
EPA is proposing to amend the
current tolerances by:
• Revising the tolerance expression
for mesosulfuron-methyl to describe
more clearly the scope or coverage of
the tolerances and the method for
measuring compliance. Consistent with
EPA policy, the revised tolerance
expression would clarify that (1) as
provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
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degradates of mesosulfuron-methyl not
specifically mentioned; and (2) that
compliance with the specified tolerance
levels is to be determined by measuring
the specific compounds mentioned in
the tolerance expression. The revisions
to the tolerance expression do not
substantively change the tolerances or,
in any way, modify the permissible
level of residues permitted by the
tolerances.
2. Safety Finding
EPA has determined that the
proposed change to the tolerance
expression would not impact EPA’s
previous safety findings for the
established tolerances for mesosulfuronmethyl, because the change has no
substantive effect on the tolerances or
supporting risk assessments, but rather
is merely intended to clarify the existing
tolerance expression. For further detail,
see Mesosulfuron-Methyl. Human
Health Draft Risk Assessment for
Registration Review, which can be
found in the docket ID number listed in
heading of this unit.
IV. Proposed Effective Date
EPA is proposing that these tolerance
actions would be effective on the date
of publication of the final rule in the
Federal Register. However, for actions
in the final rule that lower or revoke
existing tolerances, EPA is proposing an
expiration date of six months after the
date of publication of the final rule in
the Federal Register, to allow a
reasonable interval for producers in
exporting members of the World Trade
Organization’s (WTO’s) Sanitary and
Phytosanitary (SPS) Measures
Agreement to adapt to the requirements.
V. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Orders 12866: Regulatory
Planning and Review and 14094:
Modernizing Regulatory Review
This action is exempt from review
under Executive Order 12866 (58 FR
51735) (October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879)
(April 11, 2023), because it proposes to
establish or modify a pesticide tolerance
or a tolerance exemption under FFDCA
section 408. This exemption also
applies to tolerance revocations for
which extraordinary circumstances do
not exist. As such, this exemption
applies to the tolerance revocations in
this proposed rule because the Agency
knows of no extraordinary
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circumstances that warrant
reconsideration of this exemption for
those proposed tolerance revocations.
B. Paperwork Reduction Act (PRA)
This action does not impose an
information collection burden under the
PRA 44 U.S.C. 3501 et seq., because it
does not contain any information
collection activities.
lotter on DSK11XQN23PROD with PROPOSALS1
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. In
making this determination, EPA
concludes that the impact of concern for
this rule is any significant adverse
economic impact on small entities and
that the Agency is certifying that this
rule will not have a significant
economic impact on a substantial
number of small entities because the
rule has no net burden on small entities
subject to the rule. This determination
takes into account an EPA analysis for
tolerance establishments and
modifications that published in the
Federal Register of May 4, 1981 (46 FR
24950) (FRL–1809–5) and for tolerance
revocations on December 17, 1997 (62
FR 66020) (FRL–5753–1).
Additionally, in a 2001 memorandum,
EPA determined that eight conditions
must all be satisfied in order for an
import tolerance or tolerance exemption
revocation to adversely affect a
significant number of small entity
importers, and that there is a negligible
joint probability of all eight conditions
holding simultaneously with respect to
any particular revocation. See
Memorandum from Denise Keehner,
Division Director, Biological and
Economic Analysis Division, Office of
Pesticide Programs, entitled ‘‘RFA/
SBREFA Certification for Import
Tolerance Revocation’’ and dated May
25, 2001, which is available in the
docket.
For the pesticides named in this
proposed rule, EPA concludes that there
is no reasonable expectation that
residues of the pesticides for tolerances
listed in this proposed rule for
revocation will be found on the
commodities discussed in this proposed
rule, and the Agency knows of no
extraordinary circumstances that exist
as to the present proposed rule that
would change EPA’s previous analyses.
Any comments about the Agency’s
determination for this rulemaking
should be submitted to EPA along with
comments on the proposed rule and will
be addressed in the final rule.
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17:03 Sep 11, 2023
Jkt 259001
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255) (August 10,
1999), because it will not have
substantial direct effects on the states,
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249) (November
9, 2000), because it will not have
substantial direct effects on tribal
governments, on the relationship
between the Federal government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal government and Indian
tribes.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 (62 FR 19885)
(April 23, 1997) directs federal agencies
to include an evaluation of the health
and safety effects of the planned
regulation on children in federal health
and safety standards and explain why
the regulation is preferable to
potentially effective and reasonably
feasible alternatives. This action is not
subject to Executive Order 13045
because it is not a significant regulatory
action under section 3(f)(1) of Executive
Order 12866 (See Unit V.A.), and
because EPA does not believe the
environmental health or safety risks
addressed by this action present a
disproportionate risk to children.
However, EPA’s Policy on Children’s
Health applies to this action.
This rule proposes tolerance actions
under the FFDCA, which 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 . . .’’
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62497
(FFDCA 408(b)(2)(C)). 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 these proposed tolerance
actions. The Agency’s consideration is
documented in the pesticide specific
registration review decision documents.
See the pesticide specific discussions in
Unit III. and access the chemical
specific registration review documents
in each chemical docket at https://
www.regulations.gov.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
This action is not subject to Executive
Order 13211 (66 FR 28355) (May 22,
2001) because it is not a significant
regulatory action under Executive Order
12866.
I. National Technology Transfer
Advancement Act (NTTAA)
This action does not involve technical
standards under the NTTAA section
12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629)
(February 16, 1994) directs federal
agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations (people of color and/or
indigenous peoples) and low-income
populations. As discussed in more
detail in the pesticide specific risk
assessments conducted as part of the
registration review for each pesticide as
identified in Unit III., EPA has
considered the safety risks for the
pesticides subject to this rulemaking
and in the context of the tolerance
actions set out in this rulemaking. EPA
believes that the human health and
environmental conditions that exist
prior to this action do not result in
disproportionate and adverse effects on
people of color, low-income
populations, and/or indigenous peoples.
Furthermore, EPA believes that this
action is not likely to result in new
disproportionate and adverse effects on
people of color, low-income populations
and/or indigenous peoples.
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Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Proposed Rules
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 31, 2023.
Edward Messina,
Director, Office of Pesticide Programs.
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend § 180.405 by revising
paragraph (a)(1) to read as follows:
■
§ 180.405 Chlorsulfuron; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of
chlorsulfuron, including its metabolites
and degradates, in or on the
commodities in table 1 to this paragraph
(a)(1). Compliance with the tolerance
levels specified in table 1 is to be
determined by measuring only
chlorsulfuron (2-chloro-N-[[(4-methoxy6-methyl-1,3,5-triazin-2yl)amino]carbonyl]benzenesulfonamide)
in or on the commodity.
TABLE 1 TO PARAGRAPH (a)(1)
Parts per
million
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Barley, grain .........................
Barley, straw .........................
Cattle, fat ..............................
Cattle, meat ..........................
Cattle, meat byproducts .......
Goat, fat ................................
Goat, meat ............................
Goat, meat byproducts .........
Grass, forage ........................
Grass, hay ............................
Hog, fat .................................
Hog, meat .............................
Hog, meat byproducts ..........
Horse, fat ..............................
Horse, meat ..........................
Horse, meat byproducts .......
Milk .......................................
Oat, forage ............................
Oat, grain ..............................
Oat, straw .............................
Sheep, fat .............................
Sheep, meat .........................
Sheep, meat byproducts ......
Wheat, forage .......................
Wheat, grain .........................
Wheat, straw .........................
*
*
*
VerDate Sep<11>2014
*
0.1
0.5
0.3
0.3
0.3
0.3
0.3
0.3
11
19
0.3
0.3
0.3
0.3
0.3
0.3
0.1
20
0.1
0.5
0.3
0.3
0.3
20
0.1
0.5
*
17:03 Sep 11, 2023
(a) General. Tolerances are
established for residues of
primisulfuron-methyl, including its
metabolites and degradates, in or on the
commodities in table 1 to this paragraph
(a). Compliance with the tolerance
levels specified in table 1 is to be
determined by measuring only
primisulfuron-methyl (methyl 2-[[[[[4,6bis(difluoromethoxy)-2pyrimidinyl)amino]
carbonyl]amino]sulfonyl]benzoate) in or
on the commodity.
*
*
*
*
*
■ 4. Amend § 180.459 by:
■ a. Revising paragraph (a) introductory
text; and
■ b. Adding table heading ‘‘Table 1 to
Paragraph (a)’’.
The revision reads as follows:
§ 180.459 Triasulfuron; tolerances for
residues.
(a) General. Tolerances are
established for residues of triasulfuron,
including its metabolites and
degradates, in or on the commodities in
table 1 to this paragraph (a). Compliance
with the tolerance levels specified in
table 1 is to be determined by measuring
only triasulfuron (2-(2-chloroethoxy)-N[[(4-methoxy-6-methyl-1,3,5-triazin-2yl)amino]carbonyl]benzenesulfonamide)
in or on the commodity.
*
*
*
*
*
■ 5. Amend § 180.479, paragraph (a) by:
■ a. Adding table heading ‘‘Table 1 to
Paragraph (a)’’ in paragraph (a)(1);
■ b. In the Table in paragraph (a)(2):
■ i. Adding table heading ‘‘Table 2 to
Paragraph (a)’’;
■ ii. Revising the entry ‘‘Asparagus’’;
■ iii. Adding in alphabetical order the
entry ‘‘Nut, tree, group 14–12’’;
■ iv. Removing the entries ‘‘Okra’’; ‘‘Pea
and bean, succulent shelled, subgroup
6’’, ‘‘Pistachio’’, and ‘‘Vegetable,
fruiting, group 8’’; and
■ v. Adding in alphabetical order the
entry ‘‘Vegetable, fruiting, group 8–10’’.
The revisions and additions read as
follows:
§ 180.479 Halosulfuron-methyl; tolerances
for residues.
(2) * * *
Jkt 259001
TABLE 2 TO PARAGRAPH (a)
■
§ 180.452 Primisulfuron-methyl; tolerances
for residues.
Therefore, for the reasons stated in the
preamble, it is proposed that 40 CFR
chapter I be amended as follows:
Commodity
3. Amend § 180.452 by:
a. Revising paragraph (a) introductory
text, and
■ b. Adding table heading ‘‘Table 1 to
Paragraph (a)’’.
The revision reads as follows:
■
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Parts per
million
Commodity
*
*
*
Asparagus .............................
*
*
*
*
*
Nut, tree, group 14–12 .........
*
*
0.05
*
*
*
Vegetable, fruiting, group 8–
10 ......................................
*
*
1
0.05
*
*
*
*
*
6. Amend § 180.552 by:
a. Revising paragraph (a) introductory
text;
■ b. Adding the table heading ‘‘Table 1
to Paragraph (a)’’ in paragraph (a)(1);
and
■ c. Removing in Table 1 the entries
‘‘Hog, fat’’; ‘‘Hog, meat’’; and ‘‘Hog, meat
byproducts’’.
The revision reads as follows:
■
■
§ 180.552 Sulfosulfuron; tolerances for
residues.
(a) General. Tolerances are
established for residues of sulfosulfuron
(N-[[(4,6-dimethoxy-2pyrimidinyl)amino]carbonyl]-2(ethylsulfonyl)imidazo[1,2-a]pyridine-3sulfonamide), including its metabolites
and degradates, in or on the
commodities in the table in this
paragraph. Compliance with the
tolerance levels specified in this
paragraph is to be determined by
measuring only those sulfosulfuron
residues convertible to 2(ethylsulfonyl)-imidazo[1,2-a]pyridine,
expressed as the stoichiometric
equivalent of sulfosulfuron.
*
*
*
*
*
■ 7. Amend § 180.580 by:
■ a. Revising paragraph (a) introductory
text; and
■ b. Adding table heading ‘‘Table 1 to
Paragraph (a)’’ in paragraph (a)(1).
The revision reads as follows:
§ 180.580 Iodosulfuron-Methyl-sodium;
tolerances for residues.
(a) General. Tolerances are
established for residues of the herbicide
iodosulfuron-methyl-sodium, including
its metabolites and degradates, in or on
the commodities listed in the table in
this paragraph. Compliance with the
tolerance levels specified in this
paragraph is to be determined by
measuring only iodosulfuron-methylsodium (methyl 4-iodo-2-[[[[(4-methoxy6-methyl-1,3,5-triazin-2- yl)amino]
carbonyl]amino]sulfonyl] benzoate,
sodium salt), calculated as the
stoichiometric equivalent of
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iodosulfuron-methyl-sodium, in or on
the commodity.
*
*
*
*
*
■ 8. Amend § 180.591 by:
■ a. Revising paragraph (a) introductory
text;
■ b. Adding table heading ‘‘Table 1 to
Paragraph (a)’’ in paragraph (a)(1);
■ c. Revising in Table 1 the entries
‘‘Almond’’ and ‘‘Almond, hulls’’; and
■ d. Adding footnote 1 to Table 1.
The revisions and additions read as
follows:
lotter on DSK11XQN23PROD with PROPOSALS1
§ 180.591 Trifloxysulfuron; tolerances for
residues.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2023–0069; FRL–10579–07–
OCSPP]
Receipt of a Pesticide Petition Filed for
Residues of Pesticide Chemicals in or
on Various Commodities (July 2023)
Environmental Protection
Agency (EPA).
ACTION: Notice of filing of petition and
request for comment.
AGENCY:
This document announces the
Agency’s receipt of an initial filing of a
(a) General. Tolerances are
pesticide petition requesting the
established for residues of
establishment or modification of
trifloxysulfuron, including its
regulations for residues of pesticide
metabolites and degradates, in or on the chemicals in or on various commodities.
commodities in the table in this
DATES: Comments must be received on
paragraph. Compliance with the
or before October 12, 2023.
tolerance levels specified in this
ADDRESSES
: Submit your comments,
paragraph is to be determined by
identified
by
docket identification (ID)
measuring only trifloxysulfuron, Nnumber EPA–HQ–OPP–2023–0069,
[[(4,6-dimethoxy-2through the Federal eRulemaking Portal
pyrimidinyl)amino]carbonyl]-3-(2,2,2trifluoroethoxy)-2-pyridinesulfonamide. at https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not submit electronically
TABLE 1 TO PARAGRAPH (a)
any information you consider to be
Confidential Business Information (CBI)
Parts
per
Commodity
or other information whose disclosure is
million
restricted by statute. Additional
Almond 1 ................................
0.02 instructions on commenting and visiting
Almond, hulls1 .......................
0.01 the docket, along with more information
about dockets generally, is available at
*
*
*
*
*
https://www.epa.gov/dockets.
1 These tolerances expire on [DATE 6
FOR FURTHER INFORMATION CONTACT:
MONTHS AFTER DATE OF PUBLICATION IN Madison Le, Biopesticides and Pollution
THE Federal Register].
Prevention Division (BPPD) (7511M),
*
*
*
*
*
main telephone number: (202) 566–
■ 9. Amend § 180.597 by:
1400, email address: BPPDFRNotices@
epa.gov. The mailing address for each
■ a. Revising paragraph (a) introductory
contact person is Office of Pesticide
text; and
Programs, Environmental Protection
■ b. Adding table heading ‘‘Table 1 to
Agency, 1200 Pennsylvania Ave. NW,
Paragraph (a)’’ in paragraph (a)(1).
Washington, DC 20460–0001. As part of
The revision reads as follows:
the mailing address, include the contact
§ 180.597 Mesosulfuron-methyl;
person’s name, division, and mail code.
tolerances for residues.
The division to contact is listed at the
end of each application summary.
(a) General. Tolerances are
SUPPLEMENTARY INFORMATION:
established for residues of
mesosulfuron-methyl, including its
I. General Information
metabolites and degradates, in or on the
A. Does this action apply to me?
commodities in the table in this
paragraph. Compliance with the
You may be potentially affected by
tolerance levels specified in this
this action if you are an agricultural
paragraph is to be determined by
producer, food manufacturer, or
measuring only mesosulfuron-methyl,
pesticide manufacturer. The following
methyl 2-[[[[(4,6-dimethoxy-2list of North American Industrial
pyrimidinyl)amino]carbonyl]
Classification System (NAICS) codes is
amino]sulfonyl]-4-[[(methylsulfonyl)
not intended to be exhaustive, but rather
amino]methyl]benzoate.
provides a guide to help readers
*
*
*
*
*
determine whether this document
[FR Doc. 2023–19513 Filed 9–11–23; 8:45 am]
applies to them. Potentially affected
BILLING CODE 6560–50–P
entities may include:
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17:03 Sep 11, 2023
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SUMMARY:
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62499
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
commenting-epa-dockets.
3. Environmental justice. EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. To help
address potential environmental justice
issues, the Agency seeks information on
any groups or segments of the
population who, as a result of their
location, cultural practices, or other
factors, may have atypical or
disproportionately high and adverse
human health impacts or environmental
effects from exposure to the pesticides
discussed in this document, compared
to the general population.
II. What action is the Agency taking?
EPA is announcing receipt of a
pesticide petition filed under section
408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a,
requesting the establishment or
modification of regulations in 40 CFR
part 180 for residues of pesticide
chemicals in or on various food
commodities. The Agency is taking
public comment on the request before
responding to the petitioner. EPA is not
proposing any particular action at this
time. EPA has determined that the
E:\FR\FM\12SEP1.SGM
12SEP1
Agencies
[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Proposed Rules]
[Pages 62492-62499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19513]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0254; FRL-11283-01-OCSPP]
RIN 2070-ZA16
Pesticide Tolerances; Implementing Registration Review Decisions
for Certain Pesticides (FY23Q4)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to implement several tolerance actions under
the Federal Food, Drug, and Cosmetic Act (FFDCA) that the Agency
determined were necessary or appropriate during the registration review
conducted under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). During registration review, EPA reviews all aspects of a
pesticide case, including existing tolerances, to ensure that the
pesticide continues to meet the standard for registration under FIFRA.
The tolerance actions and pesticide active ingredients addressed in
this rulemaking are identified in Unit I.B. and discussed in detail in
Unit III. of this document.
DATES: Comments must be received on or before November 13, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0254, through the Federal eRulemaking
Portal at: https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Robert Little, Pesticide Re-Evaluation
Division (7508M), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-2234; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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. What action is the Agency taking?
EPA is proposing several tolerance actions that the Agency
previously determined were necessary or
[[Page 62493]]
appropriate during registration review for the following pesticide
active ingredients: chlorsulfuron, primisulfuron-methyl, triasulfuron,
halosulfuron-methyl, sulfosulfuron, iodosulfuron-methyl-sodium,
trifloxysulfuron-sodium, and mesosulfuron-methyl. The proposed
tolerance actions for each pesticide active ingredient are described in
Unit III. and may include but are not limited to the following types of
actions:
Revising tolerance expressions;
Modifying commodity definitions;
Updating crop groups;
Removing expired tolerances;
Revoking tolerances that are no longer needed; and
Harmonizing tolerances with Codex Maximum Residue Levels
(MRLs).
Although they may not have been identified in the registration
review of a particular pesticide, this rule also includes proposals to
reflect the Agency's 2019 adoption of the Organization of Economic
Cooperation and Development (OECD) Rounding Class Practice. Where
applicable, these adjustments are proposed for specific pesticides as
reflected in the proposed regulatory text section.
C. What is EPA's authority for taking this action?
Pursuant to its authority under the Federal Food, Drug and Cosmetic
Act (FFDCA), 21 U.S.C. 346a, EPA is proposing the tolerance actions in
this rulemaking that the Agency previously determined were necessary or
appropriate during the registration review conducted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq.
FFDCA section 408(b) authorizes EPA to establish a tolerance, if
the Agency determines that a tolerance is safe; FFDCA section 408(c)
authorizes EPA to establish an exemption from the requirement of a
tolerance if the Agency determines that the exemption is safe. See 21
U.S.C. 346a(b) and (c). If EPA determines that a tolerance or exemption
is not safe, EPA must modify or revoke that tolerance or exemption. 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.'' 21 U.S.C.
346a(b)(2)(A)(ii), (c)(2)(A)(ii). This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. FFDCA section 408(b)(2)(C) requires EPA to give
special consideration to the 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[s.]'' 21 U.S.C. 346a(b)(2)(C). In addition, FFDCA section
408(b)(2)(D) contains several factors EPA must consider when making
determinations about establishing, modifying, or revoking tolerances.
21 U.S.C. 346a(b)(2)(D). FFDCA section 408(c)(2)(B) requires that EPA,
when making determinations about exemptions, to take into account,
among other things, the considerations set forth in FFDCA section
408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B).
FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to
establish, modify, or revoke tolerances or exemptions from the
requirement of a tolerance on its own initiative. Prior to issuing the
final regulation, FFDCA section 408(e)(2) requires EPA to issue a
notice of proposed rulemaking for a 60-day public comment period,
unless the Administrator for good cause finds that it would be in the
public interest to have a shorter period and states the reasons in the
rulemaking.
Furthermore, when establishing tolerances or exemptions from the
requirement of a tolerance, FFDCA sections 408(b)(3) and (c)(3) require
that there be a practical method for detecting and measuring pesticide
chemical residue levels in or on food, unless in the case of
exemptions, EPA determines that such method is not needed and states
the reasons therefor in the rulemaking. 21 U.S.C. 346a(b) and (c).
Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to
periodically review all registered pesticides and determine if those
pesticides continue to meet the standard for registration under FIFRA.
See also 40 CFR 155.40(a). Consistent with its obligations under FIFRA
section 3(g) and FFDCA section 408, EPA has reviewed the available
scientific data and other relevant information and determined it is
appropriate to take the tolerance actions being proposed in this
rulemaking.
D. What can I do if I want the Agency to maintain a tolerance that the
Agency proposes to revoke?
This proposed rule provides a 60-day public comment period that
allows any person to state an interest in retaining a tolerance
proposed for revocation. If EPA receives such a comment within the 60-
day period, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f), if needed. The order would specify data needed
and the timeframes for submission of the data and would require that
within 90 days some person or persons notify EPA that they will submit
the data. If the data are not submitted as required in the order, EPA
will take appropriate action under FFDCA.
After considering comments that are received in response to this
proposed rule, EPA will issue a final rule. At the time of the final
rule, you may file an objection or request a hearing on the action
taken in the final rule. If you fail to file an objection to the final
rule within the time period specified in the final rule, you will have
waived the right to raise any issues resolved in the final rule. After
the filing deadline specified in the final rule, issues resolved in the
final rule cannot be raised again in any subsequent proceedings.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
https://www.regulations.gov or email. If you wish to include CBI in
your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the
part or all of the information that you claim to be CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.regulations.gov/faq.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies.
II. Background
A. What is a tolerance?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on food, which includes raw
agricultural commodities and processed foods and
[[Page 62494]]
feed for animals. Under the FFDCA, residues of a pesticide chemical
that are not covered by a tolerance or exemption from the requirement
of a tolerance are considered unsafe. See 21 U.S.C. 346a(a)(1). Foods
containing unsafe residues are deemed adulterated and may not be
distributed in interstate commerce. See 21 U.S.C. 331(a), 342(a)(2)(B).
Consequently, for a food-use pesticide (i.e., a pesticide use that is
likely to result in residues in or on food) to be sold and distributed,
the pesticide must not only have appropriate tolerances or exemptions
under the FFDCA, but also must be registered under FIFRA, 7 U.S.C. 136
et seq. Food-use pesticides not registered in the United States must
have tolerances or exemptions in order for commodities treated with
those pesticides to be imported into the United States. For additional
information about tolerances, go to https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances.
B. Why does EPA consider international residue limits?
When establishing a tolerance for residues of a pesticide, EPA must
determine whether the Codex Alimentarius Commission (Codex) has
established a Maximum Residue Limit (MRL) for that pesticide. See 21
U.S.C. 346a(b)(4). As part of registration review, EPA determines
whether international tolerances or MRLs exist for commodities and
chemicals for which U.S. tolerances have been established. Where
appropriate, EPA's intention is to harmonize U.S. tolerances with those
international MRLs to facilitate trade. EPA's effort to harmonize with
Codex MRLs is summarized in the tolerance reassessment section of the
individual human health risk assessments that support the pesticide
registration review.
C. What is pesticide registration review?
EPA periodically reviews existing registered pesticides to ensure
they can continue to be used without unreasonable adverse effects on
human health or the environment. The registration review program is
intended to make sure that, as the ability to assess risk evolves and
as policies and practices change, all registered pesticides continue to
meet the FIFRA registration standard of no unreasonable adverse
effects. As part of the registration review of a pesticide, EPA also
evaluates whether existing tolerances are safe, whether any changes to
existing tolerances are necessary or appropriate, and whether any new
tolerances are necessary to cover residues from registered pesticides.
Where appropriate, EPA has included a safety finding under the FFDCA
for the proposed tolerance action for the pesticide, which is discussed
in detail in the human health risk assessments conducted to support the
registration review of each specific pesticide active ingredient or
registration review case. In addition, these proposed tolerance changes
are summarized in both the Proposed Interim Decision (PID), and in the
Interim Decision (ID) for each pesticide active ingredient or
registration review case. These documents can be found in the public
docket that has been opened for each pesticide, which is available
online at https://www.regulations.gov, using the docket ID number
listed in Unit III. for each pesticide active ingredient included in
this proposed action. Additional information about pesticide
registration review is available at https://www.epa.gov/pesticide-reevaluation.
III. Proposed Tolerance Actions
EPA is proposing to take the specific tolerance actions identified
in this unit.
A. 40 CFR 180.405; Chlorsulfuron; Case 0631 (Docket ID No. EPA-HQ-OPP-
2012-0878)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Revising the tolerance expression for chlorsulfuron to
describe more clearly the scope or coverage of the tolerances and the
method for measuring compliance. Consistent with EPA policy, the
revised tolerance expression would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerances cover metabolites and
degradates of chlorsulfuron not specifically mentioned; and (2)
compliance with the specified tolerance levels is to be determined by
measuring the specific compounds mentioned in the tolerance expression.
The revisions to the tolerance expression would not substantively
change the tolerances or, in any way, modify the permissible level of
residues permitted by the tolerances.
Merging the established tolerances into a single paragraph
for clarity.
Modifying tolerance values or tolerance levels for
``Grass, forage''; ``Grass, hay''; ``Oat, forage''; and ``Wheat,
forage'' to reflect current OECD rounding practices.
2. Safety Finding
During registration review, EPA assessed the risks from exposure to
chlorsulfuron, taking into consideration all reliable data on toxicity
and exposure, including for infants and children. Based on the
supporting risk assessments and registration review documents, which
demonstrate that the aggregate exposure is below the Agency's level of
concern, EPA concludes there is a reasonable certainty that no harm
will result to the general population, or specifically to infants and
children, from aggregate exposure to chlorsulfuron residues. Thus, EPA
has determined that the tolerances for residues of chlorsulfuron are
safe. Adequate enforcement methodology as described in the supporting
documents is available to enforce the tolerance expression. For further
detail, see Chlorsulfuron. Draft Human Health Risk Assessment in
Support of Registration Review, which can be found in the docket ID
number listed in the heading of this unit.
B. 40 CFR 180.452; Primisulfuron-methyl; Case 7220 (Docket ID No. EPA-
HQ-OPP-2011-0844)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Revising the tolerance expression for primisulfuron-methyl
to describe more clearly the scope or coverage of the tolerances and
the method for measuring compliance. Consistent with EPA policy, the
revised tolerance expression would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of primisulfuron-methyl not specifically mentioned; and (2)
compliance with the specified tolerance levels is to be determined by
measuring the specific compounds mentioned in the tolerance expression.
The revisions to the tolerance expression would not substantively
change the tolerances or, in any way, modify the permissible level of
residues permitted by the tolerances.
2. Safety finding
EPA has determined that the proposed change to the tolerance
expression would not impact EPA's previous safety findings for the
established tolerances for primisulfuron-methyl, because the change has
no substantive effect on the tolerances or supporting risk assessments,
but rather is merely intended to clarify the existing tolerance
expression. For further detail, see Primisulfuron-Methyl. Human Health
Draft Risk Assessment for Registration Review, which can be found in
the
[[Page 62495]]
docket ID number listed in the heading of this unit.
C. 40 CFR 180.459; Triasulfuron; Case 7221 (Docket ID No. EPA-HQ-OPP-
2012-0115)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Revising the tolerance expression for triasulfuron to
describe more clearly the scope or coverage of the tolerances and the
method for measuring compliance. Consistent with EPA policy, the
revised tolerance expression would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of triasulfuron not specifically mentioned; and (2)
compliance with the specified tolerance levels is to be determined by
measuring the specific compounds mentioned in the tolerance expression.
The revisions to the tolerance expression would not substantively
change the tolerances or, in any way, modify the permissible level of
residues permitted by the tolerances.
2. Safety Finding
EPA has determined that the proposed change to the tolerance
expression would not impact EPA's previous safety findings for the
established tolerances for triasulfuron, because the change has no
substantive effect on the tolerances or supporting risk assessments,
but rather is merely intended to clarify the existing tolerance
expression. For further detail, see Triasulfuron. Draft Human Health
Risk Assessment in Support of Registration Review, which can be found
in the docket ID number listed in the heading of this unit.
D. 40 CFR 180.479; Halosulfuron-methyl; Case 7233 (Docket ID No. EPA-
HQ-OPP-2011-0745)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Modifying the tolerance level for residues of
halosulfuron-methyl in or on asparagus from 0.8 ppm to 1 ppm to
harmonize with the Canadian MRL. There are no Codex MRLs for this
pesticide chemical.
Converting the existing crop group tolerances for
``vegetable, fruiting, group 8'' and ``nut, tree, crop group 14'' to
the updated crop group tolerances for ``vegetable, fruiting, group 8-
10'' and ``nut, tree, crop group 14-12,'' respectively. The tolerance
levels would remain the same. 40 CFR 180.40(j) states that ``[a]t
appropriate times, EPA will amend tolerances for crop groups that have
been superseded by revised crop groups to conform the pre-existing crop
group to the revised crop group.'' EPA has indicated in updates to its
crop group rulemakings that registration review is one of those
appropriate times. See, e.g., Tolerance Crop Grouping Program V (85 FR
70976) (November 6, 2020).
Removing tolerances for residues of halosulfuron-methyl in
or on certain commodities. Specifically, EPA is proposing to remove the
tolerance for ``pea and bean, succulent shelled, subgroup 6'' because
it is an incorrect entry; no such crop subgroup exists. Instead, these
commodities are covered under the established tolerance for ``pea and
bean, succulent shelled, subgroup 6B'' at the same tolerance level. In
addition, EPA proposes to remove tolerances for okra and pistachio as
unnecessary, because they would be covered by the updated crop group
tolerances for ``vegetable, fruiting, group 8-10'' and ``nut, tree,
crop group 14-12,'' respectively, at the same tolerance levels.
2. Safety Finding
During registration review, EPA assessed the risks from exposure to
halosulfuron-methyl, taking into consideration all reliable data on
toxicity and exposure, including for infants and children. Based on the
supporting risk assessments and registration review documents, which
demonstrate that the aggregate exposure is below the Agency's level of
concern, EPA concludes there is a reasonable certainty that no harm
will result to the general population, or specifically to infants and
children, from aggregate exposure to halosulfuron-methyl residues.
Thus, EPA has determined that the tolerances for residues of
halosulfuron-methyl are safe. Adequate enforcement methodology as
described in the supporting documents is available to enforce the
tolerance expression. For further detail, see Halosulfuron-Methyl.
Draft Human Health Risk Assessment for Registration Review, which can
be found in the docket ID number listed in the heading of this unit.
E. 40 CFR 180.552; Sulfosulfuron; Case 7247 (Docket ID No. EPA-HQ-OPP-
2011-0434)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Revising the tolerance expression for sulfosulfuron to
describe more clearly the scope or coverage of the tolerances and the
method for measuring compliance. Consistent with EPA policy, the
revised tolerance expression would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of sulfosulfuron not specifically mentioned; and (2)
compliance with the specified tolerance levels is to be determined by
measuring the specific compounds mentioned in the tolerance expression.
The revisions to the tolerance expression do not substantively change
the tolerances or, in any way, modify the permissible level of residues
permitted by the tolerances.
Removing the tolerances for residues of sulfosulfuron in
or on hog, meat (0.005 ppm); hog, fat (0.005 ppm); and hog, meat
byproducts (0.05 ppm). EPA has determined that there is no reasonable
expectation of finite residues of concern in swine. See 40 CFR
180.6(a)(3). Moreover, a re-evaluation of tolerance enforcement methods
determined that the limits of quantitation for these methods is 0.01
ppm.
2. Safety Finding
During registration review, EPA assessed the risks from exposure to
sulfosulfuron, taking into consideration all reliable data on toxicity
and exposure, including for infants and children. Based on the
supporting risk assessments and registration review documents, which
demonstrate that the aggregate exposure is below the Agency's level of
concern, EPA concludes there is a reasonable certainty that no harm
will result to the general population, or specifically to infants and
children, from aggregate exposure to sulfosulfuron residues. Thus, EPA
has determined that the tolerances for residues of sulfosulfuron are
safe. Adequate enforcement methodology as described in the supporting
documents is available to enforce the tolerance expression. For further
detail, see Sulfosulfuron. Draft Human Health Risk Assessment in
Support of Registration Review, which can be found in the docket ID
number listed in the heading of this unit.
F. 40 CFR 180.580; Iodosulfuron-methyl-sodium; Case 7253 (Docket ID No.
EPA-HQ-OPP-2012-0717)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
[[Page 62496]]
Revising the tolerance expression for iodosulfuron-methyl-
sodium to describe more clearly the scope or coverage of the tolerances
and the method for measuring compliance. Consistent with EPA policy,
the revised tolerance expression would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of iodosulfuron-methyl-sodium not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring the specific compounds mentioned in the
tolerance expression. The revisions to the tolerance expression do not
substantively change the tolerances or, in any way, modify the
permissible level of residues permitted by the tolerances.
2. Safety Finding
EPA has determined that the proposed change to the tolerance
expression would not impact EPA's previous safety findings for the
established tolerances for iodosulfuron-methyl-sodium, because the
change has no substantive effect on the tolerances or supporting risk
assessments, but rather is merely intended to clarify the existing
tolerance expression. For further detail, see Iodosulfuron-Methyl-
Sodium. Draft Human Health Risk Assessment in Support of Registration
Review, which can be found in the docket ID number listed in the
heading of this unit.
G. 40 CFR 180.591; Trifloxysulfuron; Case 7028 (Docket ID No. EPA-HQ-
OPP-2013-0409)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Revising the tolerance expression for trifloxysulfuron,
resulting from the application of its sodium salt, to describe more
clearly the scope or coverage of the tolerances and the method for
measuring compliance. Consistent with EPA policy, the revised tolerance
expression would clarify that (1) as provided in FFDCA section
408(a)(3), the tolerance covers metabolites and degradates of
trifloxysulfuron not specifically mentioned; and (2) that compliance
with the specified tolerance levels is to be determined by measuring
the specific compounds mentioned in the tolerance expression. The
revisions to the tolerance expression do not substantively change the
tolerances or, in any way, modify the permissible level of residues
permitted by the tolerances.
Revoking tolerances for residues of trifloxysulfuron in or
on almond (0.02 ppm) and almond hulls (0.01 ppm). Almonds are no longer
included as a use site on any trifloxysulfuron-sodium product labels;
therefore, the Agency is proposing to revoke the established
tolerances. In addition, to allow a reasonable interval for producers
in exporting members of the World Trade Organization's (WTO's) Sanitary
and Phytosanitary (SPS) Measures Agreement to adapt to these
requirements in the final rule, EPA is proposing to amend the existing
tolerances to include an expiration date that would be six months after
the date of publication of the final rule in the Federal Register.
2. Safety Finding
During registration review, EPA assessed the risks from exposure to
trifloxysulfuron-sodium, taking into consideration all reliable data on
toxicity and exposure, including for infants and children. Based on the
supporting risk assessments and registration review documents, which
demonstrate that the aggregate exposure is below the Agency's level of
concern, EPA concludes there is a reasonable certainty that no harm
will result to the general population, or specifically to infants and
children, from aggregate exposure to trifloxysulfuron-sodium. Thus, EPA
has determined that the tolerances for residues of trifloxysulfuron,
resulting from the application of its sodium salt, are safe. Adequate
enforcement methodology as described in the supporting documents is
available to enforce the tolerance expression. For further detail, see
Trifloxysulfuron-Sodium. Draft Human Health Risk Assessment in Support
of Registration Review, which can be found in the docket ID number
listed in the heading of this unit
H. 40 CFR 180.597; Mesosulfuron-Methyl; Case 7277 (Docket ID No. EPA-
HQ-OPP-2012-0833)
1. Proposed Changes to the Current Tolerances
EPA is proposing to amend the current tolerances by:
Revising the tolerance expression for mesosulfuron-methyl
to describe more clearly the scope or coverage of the tolerances and
the method for measuring compliance. Consistent with EPA policy, the
revised tolerance expression would clarify that (1) as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of mesosulfuron-methyl not specifically mentioned; and (2)
that compliance with the specified tolerance levels is to be determined
by measuring the specific compounds mentioned in the tolerance
expression. The revisions to the tolerance expression do not
substantively change the tolerances or, in any way, modify the
permissible level of residues permitted by the tolerances.
2. Safety Finding
EPA has determined that the proposed change to the tolerance
expression would not impact EPA's previous safety findings for the
established tolerances for mesosulfuron-methyl, because the change has
no substantive effect on the tolerances or supporting risk assessments,
but rather is merely intended to clarify the existing tolerance
expression. For further detail, see Mesosulfuron-Methyl. Human Health
Draft Risk Assessment for Registration Review, which can be found in
the docket ID number listed in heading of this unit.
IV. Proposed Effective Date
EPA is proposing that these tolerance actions would be effective on
the date of publication of the final rule in the Federal Register.
However, for actions in the final rule that lower or revoke existing
tolerances, EPA is proposing an expiration date of six months after the
date of publication of the final rule in the Federal Register, to allow
a reasonable interval for producers in exporting members of the World
Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures
Agreement to adapt to the requirements.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is exempt from review under Executive Order 12866 (58
FR 51735) (October 4, 1993), as amended by Executive Order 14094 (88 FR
21879) (April 11, 2023), because it proposes to establish or modify a
pesticide tolerance or a tolerance exemption under FFDCA section 408.
This exemption also applies to tolerance revocations for which
extraordinary circumstances do not exist. As such, this exemption
applies to the tolerance revocations in this proposed rule because the
Agency knows of no extraordinary
[[Page 62497]]
circumstances that warrant reconsideration of this exemption for those
proposed tolerance revocations.
B. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this rule is any significant adverse economic
impact on small entities and that the Agency is certifying that this
rule will not have a significant economic impact on a substantial
number of small entities because the rule has no net burden on small
entities subject to the rule. This determination takes into account an
EPA analysis for tolerance establishments and modifications that
published in the Federal Register of May 4, 1981 (46 FR 24950) (FRL-
1809-5) and for tolerance revocations on December 17, 1997 (62 FR
66020) (FRL-5753-1).
Additionally, in a 2001 memorandum, EPA determined that eight
conditions must all be satisfied in order for an import tolerance or
tolerance exemption revocation to adversely affect a significant number
of small entity importers, and that there is a negligible joint
probability of all eight conditions holding simultaneously with respect
to any particular revocation. See Memorandum from Denise Keehner,
Division Director, Biological and Economic Analysis Division, Office of
Pesticide Programs, entitled ``RFA/SBREFA Certification for Import
Tolerance Revocation'' and dated May 25, 2001, which is available in
the docket.
For the pesticides named in this proposed rule, EPA concludes that
there is no reasonable expectation that residues of the pesticides for
tolerances listed in this proposed rule for revocation will be found on
the commodities discussed in this proposed rule, and the Agency knows
of no extraordinary circumstances that exist as to the present proposed
rule that would change EPA's previous analyses.
Any comments about the Agency's determination for this rulemaking
should be submitted to EPA along with comments on the proposed rule and
will be addressed in the final rule.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255) (August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249) (November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885) (April 23, 1997) directs
federal agencies to include an evaluation of the health and safety
effects of the planned regulation on children in federal health and
safety standards and explain why the regulation is preferable to
potentially effective and reasonably feasible alternatives. This action
is not subject to Executive Order 13045 because it is not a significant
regulatory action under section 3(f)(1) of Executive Order 12866 (See
Unit V.A.), and because EPA does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children. However, EPA's Policy on Children's Health applies to
this action.
This rule proposes tolerance actions under the FFDCA, which
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 . . .'' (FFDCA 408(b)(2)(C)). 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 these proposed tolerance actions. The Agency's
consideration is documented in the pesticide specific registration
review decision documents. See the pesticide specific discussions in
Unit III. and access the chemical specific registration review
documents in each chemical docket at https://www.regulations.gov.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards under the NTTAA
section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629) (February 16, 1994) directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or indigenous
peoples) and low-income populations. As discussed in more detail in the
pesticide specific risk assessments conducted as part of the
registration review for each pesticide as identified in Unit III., EPA
has considered the safety risks for the pesticides subject to this
rulemaking and in the context of the tolerance actions set out in this
rulemaking. EPA believes that the human health and environmental
conditions that exist prior to this action do not result in
disproportionate and adverse effects on people of color, low-income
populations, and/or indigenous peoples. Furthermore, EPA believes that
this action is not likely to result in new disproportionate and adverse
effects on people of color, low-income populations and/or indigenous
peoples.
[[Page 62498]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 31, 2023.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, it is proposed
that 40 CFR chapter I be amended 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. 180.405 by revising paragraph (a)(1) to read as follows:
Sec. 180.405 Chlorsulfuron; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
chlorsulfuron, including its metabolites and degradates, in or on the
commodities in table 1 to this paragraph (a)(1). Compliance with the
tolerance levels specified in table 1 is to be determined by measuring
only chlorsulfuron (2-chloro-N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)amino]carbonyl]benzenesulfonamide) in or on the commodity.
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain........................................... 0.1
Barley, straw........................................... 0.5
Cattle, fat............................................. 0.3
Cattle, meat............................................ 0.3
Cattle, meat byproducts................................. 0.3
Goat, fat............................................... 0.3
Goat, meat.............................................. 0.3
Goat, meat byproducts................................... 0.3
Grass, forage........................................... 11
Grass, hay.............................................. 19
Hog, fat................................................ 0.3
Hog, meat............................................... 0.3
Hog, meat byproducts.................................... 0.3
Horse, fat.............................................. 0.3
Horse, meat............................................. 0.3
Horse, meat byproducts.................................. 0.3
Milk.................................................... 0.1
Oat, forage............................................. 20
Oat, grain.............................................. 0.1
Oat, straw.............................................. 0.5
Sheep, fat.............................................. 0.3
Sheep, meat............................................. 0.3
Sheep, meat byproducts.................................. 0.3
Wheat, forage........................................... 20
Wheat, grain............................................ 0.1
Wheat, straw............................................ 0.5
------------------------------------------------------------------------
* * * * *
0
3. Amend Sec. 180.452 by:
0
a. Revising paragraph (a) introductory text, and
0
b. Adding table heading ``Table 1 to Paragraph (a)''.
The revision reads as follows:
Sec. 180.452 Primisulfuron-methyl; tolerances for residues.
(a) General. Tolerances are established for residues of
primisulfuron-methyl, including its metabolites and degradates, in or
on the commodities in table 1 to this paragraph (a). Compliance with
the tolerance levels specified in table 1 is to be determined by
measuring only primisulfuron-methyl (methyl 2-[[[[[4,6-
bis(difluoromethoxy)-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]benzoate) in or on the commodity.
* * * * *
0
4. Amend Sec. 180.459 by:
0
a. Revising paragraph (a) introductory text; and
0
b. Adding table heading ``Table 1 to Paragraph (a)''.
The revision reads as follows:
Sec. 180.459 Triasulfuron; tolerances for residues.
(a) General. Tolerances are established for residues of
triasulfuron, including its metabolites and degradates, in or on the
commodities in table 1 to this paragraph (a). Compliance with the
tolerance levels specified in table 1 is to be determined by measuring
only triasulfuron (2-(2-chloroethoxy)-N-[[(4-methoxy-6-methyl-1,3,5-
triazin-2-yl)amino]carbonyl]benzenesulfonamide) in or on the commodity.
* * * * *
0
5. Amend Sec. 180.479, paragraph (a) by:
0
a. Adding table heading ``Table 1 to Paragraph (a)'' in paragraph
(a)(1);
0
b. In the Table in paragraph (a)(2):
0
i. Adding table heading ``Table 2 to Paragraph (a)'';
0
ii. Revising the entry ``Asparagus'';
0
iii. Adding in alphabetical order the entry ``Nut, tree, group 14-12'';
0
iv. Removing the entries ``Okra''; ``Pea and bean, succulent shelled,
subgroup 6'', ``Pistachio'', and ``Vegetable, fruiting, group 8''; and
0
v. Adding in alphabetical order the entry ``Vegetable, fruiting, group
8-10''.
The revisions and additions read as follows:
Sec. 180.479 Halosulfuron-methyl; tolerances for residues.
(2) * * *
Table 2 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Asparagus............................................... 1
* * * * *
Nut, tree, group 14-12.................................. 0.05
* * * * *
Vegetable, fruiting, group 8-10......................... 0.05
------------------------------------------------------------------------
* * * * *
0
6. Amend Sec. 180.552 by:
0
a. Revising paragraph (a) introductory text;
0
b. Adding the table heading ``Table 1 to Paragraph (a)'' in paragraph
(a)(1); and
0
c. Removing in Table 1 the entries ``Hog, fat''; ``Hog, meat''; and
``Hog, meat byproducts''.
The revision reads as follows:
Sec. 180.552 Sulfosulfuron; tolerances for residues.
(a) General. Tolerances are established for residues of
sulfosulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-2-
(ethylsulfonyl)imidazo[1,2-a]pyridine-3-sulfonamide), including its
metabolites and degradates, in or on the commodities in the table in
this paragraph. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only those sulfosulfuron
residues convertible to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine,
expressed as the stoichiometric equivalent of sulfosulfuron.
* * * * *
0
7. Amend Sec. 180.580 by:
0
a. Revising paragraph (a) introductory text; and
0
b. Adding table heading ``Table 1 to Paragraph (a)'' in paragraph
(a)(1).
The revision reads as follows:
Sec. 180.580 Iodosulfuron-Methyl-sodium; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide iodosulfuron-methyl-sodium, including its metabolites and
degradates, in or on the commodities listed in the table in this
paragraph. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only iodosulfuron-methyl-
sodium (methyl 4-iodo-2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)amino] carbonyl]amino]sulfonyl] benzoate, sodium salt), calculated
as the stoichiometric equivalent of
[[Page 62499]]
iodosulfuron-methyl-sodium, in or on the commodity.
* * * * *
0
8. Amend Sec. 180.591 by:
0
a. Revising paragraph (a) introductory text;
0
b. Adding table heading ``Table 1 to Paragraph (a)'' in paragraph
(a)(1);
0
c. Revising in Table 1 the entries ``Almond'' and ``Almond, hulls'';
and
0
d. Adding footnote 1 to Table 1.
The revisions and additions read as follows:
Sec. 180.591 Trifloxysulfuron; tolerances for residues.
(a) General. Tolerances are established for residues of
trifloxysulfuron, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only trifloxysulfuron, N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]-3-(2,2,2-trifluoroethoxy)-2-
pyridinesulfonamide.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond \1\.............................................. 0.02
Almond, hulls\1\........................................ 0.01
* * * * *
------------------------------------------------------------------------
\1\ These tolerances expire on [DATE 6 MONTHS AFTER DATE OF PUBLICATION
IN THE Federal Register].
* * * * *
0
9. Amend Sec. 180.597 by:
0
a. Revising paragraph (a) introductory text; and
0
b. Adding table heading ``Table 1 to Paragraph (a)'' in paragraph
(a)(1).
The revision reads as follows:
Sec. 180.597 Mesosulfuron-methyl; tolerances for residues.
(a) General. Tolerances are established for residues of
mesosulfuron-methyl, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only mesosulfuron-methyl, methyl 2-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]-4-
[[(methylsulfonyl)amino]methyl]benzoate.
* * * * *
[FR Doc. 2023-19513 Filed 9-11-23; 8:45 am]
BILLING CODE 6560-50-P