[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Rules and Regulations]
[Pages 29053-29056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10204]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0204 and EPA-HQ-OPP-2021-0432; FRL-9745-01-OCSPP]
Mandestrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
mandestrobin in or on lettuce, head; lettuce, leaf; and rapeseed
subgroup 20A. The Interregional Project Number 4 (IR-4) and the
registrant, Valent U.S.A. LLC, requested these tolerances under section
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 12, 2022. Objections and
requests for hearings must be received on or before July 11, 2022 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2021-0204 and EPA-HQ-OPP-2021-
0432, are available at https://www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room and the OPP Docket is
(202) 566-1744.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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 numbers EPA-HQ-OPP-2022-0204 and EPA-HQ-OPP-2021-0432 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 July 11, 2022. 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 numbers EPA-HQ-OPP-2021-0204 and EPA-
HQ-OPP-2021-0432, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), 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
0E8888) 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 commodities:
Lettuce, head at 0.08 parts per million (ppm) and Lettuce, leaf at 4
ppm.
In the Federal Register of August 24, 2021 (86 FR 47275) (FRL-8792-
02-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
1F8925) by Valent U.S.A. LLC, 4600 Norris Canyon Road, P.O. Box 5075,
San Ramon, CA
[[Page 29054]]
94583-0975. The petition requested that 40 CFR 180.690 be amended by
establishing a tolerance for residues of mandestrobin, 2-[(2,5-
dimethylphenoxy)methyl]-[alpha]-methoxy-N-methylbenzeneacetamide, in or
on the raw agricultural commodity: Rapeseed subgroup 20A, seed at 0.2
ppm.
These documents referenced a summary of the petition prepared by
Valent U.S.A., the registrant, which are available in dockets EPA-HQ-
OPP-2021-0204 and EPA-HQ-OPP-2021-0432, https://www.regulations.gov.
There were no timely comments received in response to either of the
notices of filing. One supportive comment from the U.S. Department of
Agriculture (USDA) was submitted after the comment period for the
rapeseed subgroup 20A notice of filing closed. It was in response to
the notice of receipt of applications for new uses and is not
applicable to the notice of filing.
Based upon review of the data supporting petition 1F8925, EPA has
modified the commodity definition for Rapeseed subgroup 20A, seed. A
discussion of this modification can be found in section 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 tolerances. These updates are discussed in this
section; for a description of the rest of the EPA approach to and
assumptions for the exposure assessment, please reference Unit III.C of
the October 11, 2016, final rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposures from the new uses of mandestrobin on lettuce,
head; lettuce, leaf; and rapeseed subgroup 20A. An unrefined chronic
dietary (food and drinking water) exposure and risk assessment was
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID) Version 4.0. The chronic
assessment used tolerance level residues for all crops and assumed that
100% of the crops were treated with mandestrobin. Empirical and the
Agency's default processing factors were used where available. An acute
dietary exposure assessment was not conducted since there was no
adverse effect observed for a single dose of mandestrobin.
Drinking water exposure. The new uses do not result in an increase
in the estimated residue levels in drinking water, so EPA used the same
estimated drinking water concentrations in the chronic dietary
assessment as identified in the October 11, 2016, rulemaking.
Non-occupational exposure. There are no residential (non-
occupational) exposures expected from the proposed new uses of
mandestrobin on lettuce, nor from the proposed foliar and seed
treatment uses on rapeseed subgroup 20A. 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 based on a revised practice. 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 (1 < 2) 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 and mandestrobin does not appear
to produce a toxic metabolite produced by 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
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and
[[Page 29055]]
the chronic population adjusted dose (cPAD). Short-, intermediate-, and
chronic term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the appropriate points of
departure to ensure that an adequate margin of exposure (MOE) exists.
For linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure.
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 1-2 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 < 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.
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 New Uses and Establishment of
Permanent Tolerances on Lettuce, Head and Leaf and Rapeseed Subgroup
20A'' in docket IDs EPA-HQ-OPP-2021-0204 and EPA-HQ-OPP-2021-0432.
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 U.S. tolerance for residues of mandestrobin on rapeseed
subgroup 20A is harmonized with the Codex MRL on rapeseed at 0.2 ppm.
There are no Codex MRLs for residues of mandestrobin in or on lettuce.
C. Revisions to Petitioned-For Tolerances
The registrant proposed a tolerance on ``Rapeseed subgroup 20A,
seed''. EPA is establishing the tolerance requested with the
nomenclature ``Rapeseed subgroup 20A'' to conform to EPA's commodity
terminology.
V. Conclusion
Therefore, tolerances are established for residues of mandestrobin
in or on Lettuce, head at 0.08 ppm; Lettuce, leaf at 4 ppm; and
Rapeseed subgroup 20A at 0.2 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 to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller 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).
[[Page 29056]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides, and pests, Reporting and
recordkeeping requirements.
Dated: April 29, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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 the table in paragraph (a) by designating
the table as table 1 and adding, in alphabetical order, entries for
``Lettuce, head''; ``Lettuce, leaf''; and ``Rapeseed subgroup 20A''.
The additions read as follows:
Sec. 180.690 Mandestrobin; tolerances for residues.
* * * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * *
Lettuce, head............................................... 0.08
Lettuce, leaf............................................... 4
Rapeseed subgroup 20A....................................... 0.2
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* * * * *
[FR Doc. 2022-10204 Filed 5-11-22; 8:45 am]
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