[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Rules and Regulations]
[Pages 4732-4735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01131]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0447; FRL-10478-01-OCSPP]


Rimsulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
rimsulfuron in or on pomegranate and tropical and subtropical, small 
fruit, edible peel, subgroup 23A. The Interregional Research Project 
No. 4 (IR-4) requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 25, 2023. Objections and 
requests for hearings must be received on or before March 27, 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-2021-0447, 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 the 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].

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-2021-0447 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 
March 27, 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

[[Page 4733]]

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-2021-0447, 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/contacts.html.
    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 September 22, 2021 (86 FR 52624) (FRL-
8792-03-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 1E8926) by IR-4, North Carolina State University, 1730 
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition 
requested that 40 CFR 180.478 be amended by establishing tolerances for 
residues of the herbicide rimsulfuron (N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide), 
in or on pomegranate at 0.01 parts per million (ppm) and tropical and 
subtropical, small fruit, edible peel, subgroup 23A at 0.01 ppm. There 
were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    FFDCA section 408(b)(2)(A)(i) 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.'' FFDCA section 
408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C) 
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 rimsulfuron including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with rimsulfuron 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 rimsulfuron 
in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to rimsulfuron 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 rimsulfuron, see Unit III.A of the February 12, 2018, final 
rulemaking (83 FR 5942) (FRL-9972-36).
    Points of departure/Levels of concern. A summary of the 
toxicological endpoints for rimsulfuron used for human risk assessment 
is discussed in Unit III.B of the February 12, 2018, 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 February 12, 2018, final rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposures from the new uses of rimsulfuron on pomegranate 
and tropical and subtropical, small fruit, edible peel, subgroup 23A. 
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 4.02. This software incorporates 2005-2010 consumption data 
from the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). 
The chronic assessment used tolerance level residues for all crops and 
assumed that 100% of the crops were treated with rimsulfuron. 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 rimsulfuron.
    Dietary exposure from drinking water. 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 Unit III.C of the February 12, 
2018, rulemaking.
    From non-dietary exposure. There are no proposed residential uses 
at this time; however, there are existing residential uses on turf that 
have been previously assessed using current data and assumptions. For 
the residential assessment of the turf uses, EPA did not conduct a 
quantitative residential handler risk assessment. The end use label 
requires handlers to wear specific clothing (long-sleeve shirt and long 
pants) and chemical-resistant gloves, so EPA assumed the product is not 
for homeowner use. There is the potential for post-application dermal 
exposures; however, a residential post-application dermal exposure 
assessment was not conducted because no dermal hazard was identified in 
the rimsulfuron database. The quantifiable post-application residential 
risk estimates reflect incidental oral exposure to children 1 to less 
than 2 years old from hand-to-mouth exposure to turf treated with 
rimsulfuron. The margin of exposure (MOE) is 26,000, which is greater 
than the level of concern of 100 and is not of concern.

[[Page 4734]]

    Cumulative effects from substances with a common mechanism of 
toxicity. In 2016, EPA's Office of Pesticide Programs released a 
guidance document entitled, Pesticide Cumulative Risk Assessment: 
Framework for Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. The agency has utilized this framework for rimsulfuron and 
determined that although rimsulfuron shares some chemical and/or 
toxicological characteristics (e.g., chemical structure or apical 
endpoint) with other pesticides, the toxicological database does not 
support a testable hypothesis for a common mechanism of action. No 
further data are required to determine that no common mechanism of 
toxicity exists for rimsulfuron and other pesticides and no further 
cumulative evaluation is necessary for rimsulfuron.
    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 February 12, 2018, 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 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 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 rimsulfuron. 
Chronic dietary risks are below the Agency's level of concern of 100% 
of the cPAD; they are 1.8% of the cPAD for all infants (<1 year old), 
the population group receiving the greatest exposure.
    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. The short-term aggregate risk estimate 
for children 1 to less than 2 years old is an MOE of 3,700, which is 
greater than the level of concern of 100 and is not of concern. Acute 
risks are not expected due to no adverse effect observed for a single 
dose of rimsulfuron; 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. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD, no 
further assessment of intermediate-term risk is necessary. Based on the 
lack of evidence of carcinogenicity in two adequate rodent 
carcinogenicity studies, rimsulfuron is not expected to pose a cancer 
risk to humans.
    Therefore, based on the risk assessments and information described 
above, EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, or to infants and children from 
aggregate exposure to rimsulfuron residues. More detailed information 
on this action can be found in the document ``Rimsulfuron. Human Health 
Risk Assessment in Support of a Petition for the Establishment of 
Permanent Tolerances on Pomegranate and Tropical and Subtropical, Small 
Fruit, Edible Peel, Subgroup 23A'' in docket ID No. EPA-HQ-OPP-2021-
0447.

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 February 12, 2018, 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). Codex has not established MRLs for residues of 
rimsulfuron in or on any commodity associated with this action.

V. Conclusion

    Therefore, tolerances are established for residues of rimsulfuron 
(N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-
pyridinesulfonamide), in or on pomegranate at 0.01 ppm and tropical and 
subtropical, small fruit, edible peel, subgroup 23A at 0.01 ppm.
    In addition, as a housekeeping measure, EPA is removing the 
tolerance for potato at 0.1 ppm, which expired on August 12, 2018, and 
has no effect at this time.

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 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

[[Page 4735]]

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 (CRA)

    Pursuant to the CRA (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: January 13, 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.  180.478, in paragraph (a) amend table 1 by:
0
a. Adding in alphabetical order the entry ``Pomegranate'';
0
b. Removing the entry for ``Potato'' and the footnote; and
0
c. Adding in alphabetical order the entry ``Tropical and subtropical, 
small fruit, edible peel, subgroup 23A''.
    The additions read as follows:


Sec.  180.478  Rimsulfuron; tolerances for residues

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Pomegranate.............................................            0.01
 
                              * * * * * * *
Tropical and subtropical, small fruit, edible peel,                 0.01
 subgroup 23A...........................................
 
                              * * * * * * *
------------------------------------------------------------------------

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[FR Doc. 2023-01131 Filed 1-24-23; 8:45 am]
BILLING CODE 6560-50-P


