[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 [www.gpo.gov]
[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 
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 OPP Docket is (202) 566-1744. For the latest status 
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

[[Page 14496]]


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 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:
     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 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, https://www.regulations.gov. 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

[[Page 14497]]

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.......................................
------------------------------------------------------------------------

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[FR Doc. 2023-04807 Filed 3-8-23; 8:45 am]
BILLING CODE 6560-50-P


