Proposed Rule2023-19513
Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (FY23Q4)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 12, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 175 (Tuesday, September 12, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#f5999c81819990db879a97908781b5908594db929a83"><span class="__cf_email__" data-cfemail="bcd0d5c8c8d0d992ced3ded9cec8fcd9ccdd92dbd3ca">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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:
<bullet> Revising tolerance expressions;
<bullet> Modifying commodity definitions;
<bullet> Updating crop groups;
<bullet> Removing expired tolerances;
<bullet> Revoking tolerances that are no longer needed; and
<bullet> 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in
your comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> 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 <a href="https://www.regulations.gov/faq">https://www.regulations.gov/faq</a>.
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 <a href="https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances">https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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 <a href="https://www.epa.gov/pesticide-reevaluation">https://www.epa.gov/pesticide-reevaluation</a>.
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:
<bullet> 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.
<bullet> Merging the established tolerances into a single paragraph
for clarity.
<bullet> 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:
<bullet> 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:
<bullet> 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:
<bullet> 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.
<bullet> 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).
<bullet> 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:
<bullet> 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.
<bullet> 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]]
<bullet> 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:
<bullet> 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.
<bullet> 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:
<bullet> 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 <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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