Rule2022-21186
Propamocarb; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 30, 2022
Effective
September 30, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 189 (Friday, September 30, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21186]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0520; FRL-10174-01-OCSPP]
Propamocarb; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#60322426322e0f1409030513200510014e070f16"><span class="__cf_email__" data-cfemail="aefceae8fce0c1dac7cdcbddeecbdecf80c9c1d8">[email protected]</span></a>.
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
[[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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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 <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
filing.
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-
33).
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
[[Page 59327]]
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:
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. 180.499, 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
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* * * * *
Kale\1\................................................... 20
* * * * *
Leek \1\................................................... 30
Onion, bulb, crop subgroup 3-07A \1\....................... 2
* * * * *
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\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]
BILLING CODE 6560-50-P
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