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[Federal Register Volume 89, Number 234 (Thursday, December 5, 2024)]
[Rules and Regulations]
[Pages 96566-96569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28467]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0257; FRL-12338-01-OCSPP]

Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyazofamid in or on multiple crops listed later in this document. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2024. Objections and 
requests for hearings must be received on or before February 3, 2025 
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-2023-0257, 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: Charles Smith, 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(g), 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-2023-0257 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 
February 3, 2025.
    The EPA's Office of Administrative Law Judges (OALJ), in which the 
Hearing Clerk is housed, urges parties to file and serve documents by 
electronic means only, notwithstanding any other particular 
requirements set forth in other procedural rules governing those 
proceedings. See ``Revised Order Urging Electronic Filing and 
Service,'' dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. 
Although the EPA's regulations require submission via U.S. Mail or hand 
delivery, the EPA intends to treat submissions filed via electronic 
means as properly filed submissions; therefore, the EPA believes the 
preference for submission via electronic means will not be prejudicial. 
When submitting documents to the OALJ electronically, a person should 
utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    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-2023-0257, by one of 
the following methods:
     Federal eRulemaking Portal: http://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, are available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 26, 2023 (88 FR 73571) (FRL-
10579-09-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 3E9064) by IR-4, North Carolina State University, 1730 
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition 
requested to establish tolerances in 40 CFR 180.601 for residues of the 
fungicide cyazofamid, including its metabolites and degradates, in or 
on the following raw agricultural commodities: Chick pea, edible podded 
at 0.5 ppm; Chick pea, succulent shelled at 0.08 ppm; Edible podded 
bean subgroup 6-22A at 0.5 ppm; Parsnip root at 0.09 ppm; Pulses, dried 
shelled bean, except soybean, subgroup 6-22E at 0.03 ppm; and Succulent 
shelled bean subgroup 6-22C at 0.08 ppm. The petition also proposed to 
remove established tolerances for residues of cyazofamid in or on the 
following: Bean, succulent at 0.5 ppm and Bean, succulent shelled at 
0.08 ppm.
    EPA has modified some of the commodity definitions to be consistent 
with Agency nomenclature, but the

[[Page 96567]]

tolerance levels are being established as petitioned for.
    That document referenced a summary of the petition, which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice.

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 therein, 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 cyazofamid including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with cyazofamid 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 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 several tolerance rulemakings for 
cyazofamid, in which EPA concluded, based on the available information, 
that there is a reasonable certainty that no harm would result from 
aggregate exposure to cyazofamid and established tolerances for 
residues of that chemical. EPA is incorporating previously published 
sections of those rulemakings that remain unchanged, as described 
further in this rulemaking. Specific information on the risk assessment 
conducted in support of this action, including on the studies received 
and the nature of the adverse effects caused by cyazofamid, can be 
found in the document titled ``Cyazofamid: Human Health Risk Assessment 
for New Uses of Cyazofamid on Parsnip, Root and Pulses, Dried Shelled 
Bean (Except Soybean), Subgroup 6-22E and Crop Group Expansions to 
Edible Podded Bean Subgroup 6-22A and Succulent Shelled Bean Subgroup 
6-22C'' which is available in the docket for this action at https://www.regulations.gov.
    Toxicological profile. For a discussion of the Toxicological 
Profile of cyazofamid, see Unit III.A. of the rulemaking published in 
the Federal Register of March 18, 2020 (85 FR 15387) (FRL-10005-85).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern used for the 
safety assessment of cyazofamid, see Unit III.B. of the rulemaking 
published in the Federal Register of February 3, 2016 (81 FR 5600) 
(FRL-9940-46).
    Exposure assessment. Much of the exposure assessment remains 
unchanged from the March 18, 2020, rulemaking, although the new 
exposure assessment incorporates the additional dietary exposure from 
the petitioned-for tolerances. Other changes are described below.
    No acute dietary toxicity endpoint could be identified based on the 
toxicology data currently available for cyazofamid; therefore, a 
quantitative acute assessment was not performed.
    Chronic aggregate dietary (food and drinking water) exposure and 
risk assessments were conducted using the Dietary Exposure Evaluation 
Model software with the Food Commodity Intake Database (DEEM-FCID) 
Version 4.02. This software uses 2005-2010 food 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 conservative chronic analysis assumed that cyazofamid residues are 
present in/on all proposed and registered food commodities at tolerance 
levels and 100 percent crop treated.
    Anticipated residue and percent crop treated (PCT) information. EPA 
did not use anticipated residue or PCT information in the dietary 
assessment for cyazofamid. Tolerance-level residues and 100 PCT were 
assumed for all food commodities.
    Drinking water and non-occupational exposures. For a summary of the 
drinking water numbers used, see Unit III.A. of the March 18, 2020, 
rulemaking. A chronic estimated drinking water concentration (EDWC) of 
211 parts per billion (ppb) was used in the chronic dietary exposure 
assessment.
    Cyazofamid is currently registered for the following uses that 
could result in residential exposures: Turf and ornamentals. The post-
application assessment includes only post-application exposure (to turf 
and ornamentals) from hand-to-mouth exposures for children 1 to less 
than 2 years old.
    Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires 
that, when considering whether to establish, modify, or revoke a 
tolerance, the Agency consider ``available information'' concerning the 
cumulative effects of a particular pesticide's residues and ``other 
substances that have 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. 
This document provides guidance on how to screen groups of pesticides 
for cumulative evaluation using a two-step approach beginning with the 
evaluation of available toxicological information and, if necessary, 
followed by a risk-based screening approach. This framework supplements 
the existing guidance documents for establishing common mechanism 
groups (CMGs) and conducting cumulative risk assessments (CRA). The 
Agency has utilized this framework for cyazofamid and determined that 
although cyazofamid 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 cyazofamid and other pesticides and no further cumulative 
evaluation is necessary for cyazofamid.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data showing that the safety of infants and 
children would be adequately protected if the Food Quality Protection 
Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for 
that decision are articulated in Unit III.D. of the March 18, 2020, 
rulemaking.

[[Page 96568]]

    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 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.
    No acute dietary toxicity endpoint could be identified based on the 
toxicology data currently available for cyazofamid; therefore, a 
quantitative acute assessment was not performed. Chronic dietary (food 
and drinking water) risks are below the Agency's level of concern of 
100% of the cPAD; they are 2.1% of the cPAD for all infants less than 1 
year old, which is the population subgroup with the highest exposure 
estimate.
    The short-term aggregate risks combine chronic dietary (food and 
drinking water) and short-term residential exposures. For the short-
term aggregate risk for children 1 to less than 2 years old, the 
aggregate MOE combining dietary exposure and incidental oral (hand-to-
mouth) exposure is 6300. MOEs below 100 are of concern; this MOE is 
above 100 and therefore is not of concern.
    Intermediate-term exposure is not expected for the residential 
exposure pathway. Therefore, the intermediate-term aggregate risk 
estimate is equivalent to chronic dietary exposure estimates, which are 
not of concern.
    Chronic exposure is not expected for the residential exposure 
pathway. Therefore, the chronic aggregate risk estimate is equivalent 
to chronic dietary exposure estimates and are not of concern.
    Because cyazofamid is classified as ``not likely to be carcinogenic 
to humans'', EPA has concluded that aggregate exposure to cyazofamid is 
not likely to pose a cancer risk.
    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 cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the March 18, 2020, 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).
    There are no Codex MRLs established on parsnip, root; chickpea, 
edible podded; chickpea, succulent shelled; or any of the commodities 
in the Vegetable, legume, pulse, bean, dried shelled, except soybean, 
subgroup 6-22E.
    The proposed US tolerances for expansions to crop subgroups 6-22A 
and 6-22C are not harmonized with similar individually established 
slightly lower Codex MRLs for these commodities. The U.S. tolerances 
are slightly higher because the U.S. tolerance expression includes the 
parent compound and a metabolite, while the Codex tolerance expression 
includes only the parent compound.

V. Conclusion

    Therefore, tolerances are established for residues of cyazofamid in 
or on Chickpea, edible podded at 0.5 ppm; Chickpea, succulent shelled 
at 0.08 ppm; Parsnip, roots at 0.09 ppm; Vegetable, legume, bean, 
edible podded, subgroup 6-22A at 0.5 ppm; Vegetable, legume, bean, 
succulent shelled, subgroup 6-22C at 0.08 ppm; and Vegetable, legume, 
pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.03 ppm.
    Additionally, the established tolerances on Bean, succulent; and 
Bean, succulent shelled are removed as unnecessary.

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

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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: November 22, 2024.
Charles Smith,
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.  180.601, add a heading to the table in paragraph (a) and 
revise and republish the table to read as follows:

Sec.  180.601   Cyazofamid; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 4-16B..............                  15
Bulb vegetables, group 3-07.........................                 2.0
Carrot, roots.......................................                0.09
Chickpea, edible podded.............................                 0.5
Chickpea, succulent shelled.........................                0.08
Ginseng.............................................                 0.3
Herb subgroup 19A...................................                  90
Hop dried cones.....................................                10.0
Kohlrabi............................................                 1.5
Leafy greens subgroup 4-16A.........................                  10
Parsnip, roots......................................                0.09
Vegetable, brassica, head and stem, group 5-16......                 1.5
Vegetable, cucurbit, group 9........................                0.10
Vegetable, fruiting, group 8-10.....................                 0.9
Vegetable, legume, bean, edible podded, subgroup 6-                  0.5
 22A................................................
Vegetable, legume, bean, succulent shelled, subgroup                0.08
 6-22C..............................................
Vegetable, legume, pulse, bean, dried shelled,                      0.03
 except soybean, subgroup 6-22E.....................
Vegetable, tuberous and corm, subgroup 1C...........                0.02
------------------------------------------------------------------------

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[FR Doc. 2024-28467 Filed 12-4-24; 8:45 am]
BILLING CODE 6560-50-P
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