Rule2023-04807
Mandestrobin; Pesticide Tolerances
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
March 9, 2023
Effective
March 9, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of mandestrobin in or on Vegetable, tuberous and corm, except potato, subgroup 1D. The Interregional Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 46 (Thursday, March 9, 2023)</title>
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[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Rules and Regulations]
[Pages 14495-14498]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04807]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0101; FRL-10739-01-OCSPP]
Mandestrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
mandestrobin in or on Vegetable, tuberous and corm, except potato,
subgroup 1D. The Interregional Project Number 4 (IR-4) requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 9, 2023. Objections and
requests for hearings must be received on or before May 8, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0101, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and OPP Docket is (202) 566-1744. For the latest status
information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#1c4e585a4e527368757f796f5c796c7d327b736a"><span class="__cf_email__" data-cfemail="c89a8c8e9a86a7bca1abadbb88adb8a9e6afa7be">[email protected]</span></a>.
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SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0101 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
May 8, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0101, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
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>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of February 25, 2022 (87 FR 10760) (FRL-
9410-01-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1E8961) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.690 be amended by establishing tolerances for
residues of mandestrobin, 2-[(2,5-dimethylphenoxy)methyl]-[alpha]-
methoxy-N-methylbenzeneacetamide, in or on the raw agricultural
commodity: Vegetable, tuberous and corm, except potato, subgroup 1D at
0.01 parts per million (ppm). That document referenced a summary of the
petition prepared by IR-4, the petitioner, which is available in the
docket, EPA-HQ-OPP-2022-0101, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. One comment
was received on the notice of filing. EPA's response to the comment is
discussed in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for mandestrobin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with mandestrobin follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking and republishing the same sections is unnecessary.
EPA considers referral back to those sections as sufficient to provide
an explanation of the information EPA considered in making its safety
determination for the new rulemaking.
EPA has previously published a tolerance rulemaking for
mandestrobin in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to mandestrobin and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from this rulemaking as described further
in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of mandestrobin, see Unit III.A. of the October 11, 2016, final
rulemaking (81 FR 70038) (FRL-9945-37).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
mandestrobin used for human risk assessment, please reference Unit
III.B. of the October 11, 2016, final rulemaking.
Exposure assessment. Much of the exposure assessment remains the
same although updates have occurred to accommodate the exposures from
the petitioned-for tolerance. These updates are discussed in this
section; for a description of the rest of the EPA approach to and
assumptions for the
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exposure assessment, please reference Unit III.C. of the October 11,
2016, final rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposures from the new use of mandestrobin on the
commodities in vegetable, tuberous and corm, except potato, subgroup
1D. An unrefined chronic dietary (food and drinking water) exposure and
risk assessment was conducted using the Dietary Exposure Evaluation
Model software with the Food and Commodity Intake Database (DEEM-FCID)
Version 4.02. The chronic assessment used tolerance level residues for
all crops and assumed that 100% of the crops were treated with
mandestrobin. Empirical processing factors and the Agency's default
processing factors were used. An acute dietary exposure assessment was
not conducted since there was no adverse effect observed for a single
dose of mandestrobin.
Dietary water exposure. The new use does not result in an increase
in the estimated residue levels in drinking water, so EPA used the same
estimated drinking water concentrations in the chronic dietary
assessments as identified in the October 11, 2016, rulemaking.
Non-occupational exposure. There are no residential (non-
occupational) exposures expected from the proposed new use of
mandestrobin on vegetable, tuberous and corm, except potato, subgroup
1D. However, there are registered uses of mandestrobin on turf grasses
that cause non-occupational exposures. EPA's residential exposure
assessment has changed since the October 11, 2016, rulemaking. Because
all current mandestrobin labels require handlers to wear specific
clothing and personal protective equipment, EPA now assumes that
mandestrobin is applied by professional applicators, not residential
(homeowner) applicators. Therefore, the current assessment does not
consider exposure to residential handlers. For residential post-
application exposure, only hand-to-mouth exposures for children 1 to
less than 2 years old were assessed, as a dermal endpoint was not
selected.
Cumulative exposure. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
mandestrobin and any other substances. For the purposes of this action,
therefore, EPA has not assumed that mandestrobin has a common mechanism
of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor (SF) from 10X to 1X for all
risk scenarios. See Unit III.D. of the October 11, 2016, final
rulemaking for a discussion of the Agency's rationale for that
determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic population adjusted dose (cPAD). Short-, intermediate-,
and chronic term aggregate risks are evaluated by comparing the
estimated total food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists.
An acute dietary exposure assessment was not conducted since there
was no adverse effect observed for a single dose of mandestrobin.
Chronic dietary risks are below the Agency's level of concern of 100%
of the cPAD; they are 2.7% of the cPAD for children 1 to 2 years old,
the most highly exposed population subgroup.
The short-term aggregate exposure assessment for children 1 to less
than 2 years old includes dietary (food and drinking water) and
incidental oral exposure from hand-to-mouth activities from post-
application exposure to turf applications. The short-term aggregate
risk estimate for children 1 to less than 2 years old is an MOE of
2,900, which is greater than the level of concern of 100 and is not of
concern. An adult aggregate assessment was not conducted because there
are no existing/proposed residential handler scenarios. Since the
short- and intermediate-term points of departure (PODs) are the same
and short-term exposure estimates are greater than their intermediate-
term counterparts, the short-term aggregate risk assessment is
protective of the intermediate-term aggregate exposure. An acute
aggregate exposure assessment was not required due to no adverse effect
observed for a single dose for mandestrobin; and chronic aggregate
risks to adults and children are equivalent to the dietary (food and
drinking water) risks for those respective assessments and are not of
concern.
Mandestrobin is classified as ``not likely to be a human
carcinogen'' based on the lack of treatment-related tumors in the
combined chronic/oncogenicity rat study or in the carcinogenicity mouse
study, and the lack of genotoxicity in an acceptable battery of
mutagenicity studies. As a result, EPA concludes that mandestrobin is
not likely to pose a cancer risk as a result of aggregate exposure to
the pesticide chemical residue.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to mandestrobin residues. More detailed information
on this action can be found in the document ``Mandestrobin. Human
Health Risk Assessment in support of Proposed Use on Vegetable,
Tuberous and Corm, except Potato, Subgroup 1D'' in docket ID EPA-HQ-
OPP-2022-0101.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method for
various crops, see Unit IV.A of the October 11, 2016, rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
The Codex has not established an MRL for mandestrobin in or on
Vegetable, tuberous and corm, except potato, subgroup 1D.
C. Response to Comments
One comment was received in response to the Notice of Filing. The
comment stated in part that the Agency should deny this petition
because ``nobody is testing these toxic chemicals to see how they
affect big eaters over 100 years of life so that we know how they can
kil (sic) you.'' Although the Agency recognizes that some individuals
believe that pesticides should be banned on agricultural crops, the
existing legal framework provided by section 408 of the FFDCA
authorizes EPA to establish tolerances when it determines that the
tolerance is safe. Upon consideration of the validity, completeness,
and reliability of the available data as well as other factors the
FFDCA requires EPA to consider, EPA has determined that mandestrobin
tolerances are safe. The commenter has provided no information
indicating that a safety determination cannot be supported.
[[Page 14498]]
V. Conclusion
Therefore, tolerances are established for residues of mandestrobin,
in or on Vegetable, tuberous and corm, except potato, subgroup 1D at
0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 3, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.690, amend table 1 to paragraph (a) by adding in
alphabetical order an entry for ``Vegetable, tuberous and corm, except
potato, subgroup 1D'' to read as follows:
Sec. 180.690 Mandestrobin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Commodity Parts per million
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* * * * * * *
Vegetable, tuberous and corm, except potato, 0.01
subgroup 1D.......................................
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-04807 Filed 3-8-23; 8:45 am]
BILLING CODE 6560-50-P
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