[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Rules and Regulations]
[Pages 59324-59327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21186]



40 CFR Part 180

[EPA-HQ-OPP-2021-0520; FRL-10174-01-OCSPP]

Propamocarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
propamocarb in or on onion, bulb, crop subgroup 3-07A; leek; and kale. 
Bayer Crop Science LP requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 30, 2022. Objections and 
requests for hearings must be received on or before November 29, 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 docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0520, 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: Marietta Echeverria, Registration 
Division (7505P), 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].


I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 

[[Page 59325]]

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-2021-0520 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 
November 29, 2022. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b), although the 
Office of Administrative Law Judges encourages parties to file 
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    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-2021-0520, 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 
     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 December 21, 2021 (86 FR 72200) (FRL-
8792-06-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 0E8891) by Bayer Crop Science LP, 800 N Lindbergh Blvd., 
St Louis, MO 263167. The petition requested that 40 CFR 180.499 be 
amended by establishing tolerances for residues of the fungicide 
propamocarb, in or on onion, bulb, crop subgroup 3-07A at 2 parts per 
million (ppm); leek at 30 ppm; and kale at 20 ppm. That document 
referenced a summary of the petition prepared by Bayer Crop Science LP, 
the registrant, which is available in the docket, https://www.regulations.gov. This supersedes the paragraph published in the 
Federal Register on September 22, 2021 (86 FR 52624) (FRL-8792-03-
OCSPP). There were no comments received in response to either notice of 

III. Aggregate Risk Assessment and Determination of Safety

A. Statutory Background

    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 propamocarb including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with propamocarb follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that would repeat 
what has been previously published in tolerance rulemakings for the 
same pesticide chemical. Where scientific information concerning a 
particular pesticide chemical remains unchanged, the content of those 
sections would not vary between tolerance rulemakings and republishing 
the same sections is unnecessary and duplicative. 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 number of tolerance rulemakings for 
propamocarb, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to propamocarb and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from those rulemakings as described 
further in this rulemaking, as they remain unchanged.

B. Toxicological Profile

    For a summary of the Toxicological Profile of propamocarb, see Unit 
III.A. of the December 5, 2019, rulemaking (84 FR 66616) (FRL-10000-

C. Toxicological Points of Departure/Levels of Concern

    For a summary of the Toxicological Points of Departure/Levels of 
Concern used for the risk assessment, see Unit III.B. of the February 
7, 2017, rulemaking (82 FR 9519) (FRL-9957-68).

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D. Exposure Assessment

    Much of the exposure assessment remains the same, although the 
dietary exposure and risk assessments for propamocarb were updated. 
These updates are discussed in this section; for a description of the 
rest of EPA's approach to and assumptions for the exposure assessment, 
see Unit III.C. of the December 5, 2019, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposures to residues of propamocarb on imported commodities 
of onion, bulb, crop subgroup 3-07A, leek and kale. The assessment used 
the same assumptions as the December 5, 2019, rule concerning 
tolerance-level residues, default, and empirical processing factors and 
100% crop treated (PCT) for all commodities in both the acute and 
chronic dietary exposure assessments.
    Drinking water, non-occupational, and cumulative exposures. 
Drinking water and non-occupational exposures are not impacted by the 
tolerances for imported commodities, and thus have not changed since 
the last assessment. For a summary of the dietary exposures from 
drinking water, see Unit III.C.2. of the December 5, 2019, rulemaking. 
Propamocarb is registered for use on golf course turf resulting in 
potential residential post-application dermal exposure. Because the 
Agency has not identified a dermal endpoint, a quantitative residential 
dermal exposure assessment was not necessary and was not conducted. 
EPA's conclusions concerning cumulative risk remain unchanged from Unit 
III.C.4. of the December 5, 2019, rulemaking.
    Safety factor for infants and children. EPA continues to conclude 
that there is reliable data showing that the safety of infants and 
children would be adequately protected if the Food Quality Protection 
Act (FQPA) Safety Factor (SF) were reduced from 10X to 1X for all 
exposure scenarios. The reasons for that decision are articulated in 
Unit III.D in the December 5, 2019, rulemaking.
    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 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.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 42% of the aPAD for all infants, the most highly 
exposed subpopulation. Chronic dietary risks are below the Agency's 
level of concern of 100% of the cPAD; they are 54% of the cPAD for 
females 13 to 49 years old, the most highly exposed subpopulation.
    Because no short-term or intermediate term adverse effect was 
identified, propamocarb is not expected to pose a short-term or 
intermediate-term risk.
    Additionally, based on the lack of evidence of carcinogenicity in 
two adequate rodent carcinogenicity studies, propamocarb is not 
expected to pose a cancer risk to humans. 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 
propamocarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the December 5, 2019, 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 Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for propamocarb in or on onion, 
bulb, crop subgroup 3-07A at 2 ppm; leek at 30 ppm; and kale at 20 ppm. 
The U.S. tolerances are harmonized with the relevant Codex MRLs.

V. Conclusion

    Therefore, tolerances are established for residues of propamocarb 
in or on onion, bulb, crop subgroup 3-07A at 2 ppm; leek at 30 ppm; and 
kale at 20 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

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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: September 15, 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 I as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.499, amend Table 1 to Paragraph (a) by adding in 
alphabetical order the entries ``Kale'', ``Leek'', and ``Onion, bulb, 
crop subgroup 3-07A'' and footnote 1 to read as follows:

Sec.  180.499  Propamocarb; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (A)
                                                              Parts per
                         Commodity                             million
                                * * * * *
 Kale\1\...................................................           20
                                * * * * *
Leek \1\...................................................           30
Onion, bulb, crop subgroup 3-07A \1\.......................            2
                               * * * * *
\1\ There are no U.S. registrations for these commodities as of
  September 30, 2022.

* * * * *

[FR Doc. 2022-21186 Filed 9-29-22; 8:45 am]