Rule2023-17135
(2S)-5-Oxopyrrolidine-2-carboxylic Acid (L-PCA); Exemption From the Requirement of a Tolerance
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
August 10, 2023
Effective
August 10, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of (2S)-5-Oxopyrrolidine-2-carboxylic Acid (L-PCA) in or on all food commodities when used as a plant growth regulator in accordance with label directions and good agricultural practices. Exponent, on behalf of Verdesian Life Sciences U.S., LLC, submitted a petition, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), asking the EPA to amend its regulations to establish an exemption from the requirement of a tolerance for residues of the pesticide, when used as a plant growth regulator on agricultural crops, turf and ornamental plants. Instead, EPA is establishing an exemption from the requirement of a tolerance for residues L-PCA in or on all food commodities when applied in buffered end-use products and used in accordance with label directions and good agricultural practices. This regulation eliminates the need to establish a maximum permissible level for residues of L-PCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Rules and Regulations]
[Pages 54244-54247]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17135]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0158; FRL-11022-01-OCSPP]
(2S)-5-Oxopyrrolidine-2-carboxylic Acid (L-PCA); Exemption From
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of (2S)-5-Oxopyrrolidine-2-carboxylic Acid
(L-PCA) in or on all food commodities when used as a plant growth
regulator in accordance with label directions and good agricultural
practices. Exponent, on behalf of Verdesian Life Sciences U.S., LLC,
submitted a petition, pursuant to the Federal Food, Drug, and Cosmetic
Act (FFDCA), asking the EPA to amend its regulations to establish an
exemption from the requirement of a tolerance for residues of the
pesticide, when used as a plant growth regulator on agricultural crops,
turf and ornamental plants. Instead, EPA is establishing an exemption
from the requirement of a tolerance for residues L-PCA in or on all
food commodities when applied in buffered end-use products and used in
accordance with label directions and good agricultural practices. This
regulation eliminates the need to establish a maximum permissible level
for residues of L-PCA when used in accordance with this exemption.
DATES: This regulation is effective August 10, 2023. Objections and
requests for hearings must be received on or before October 10, 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-2018-0158, 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 and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Madison Le, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; email address:
<a href="/cdn-cgi/l/email-protection#98dac8c8dcdecad6f7ecf1fbfdebd8fde8f9b6fff7ee"><span class="__cf_email__" data-cfemail="90d2c0c0d4d6c2deffe4f9f3f5e3d0f5e0f1bef7ffe6">[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 producer, food manufacturer, greenhouse owner, 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 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(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-2018-0158 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
October 10, 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-2018-0158, 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
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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/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</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. Background and Statutory Findings
In the Federal Register of May 18, 2018 (83 FR 23247) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F8663) by Exponent, on behalf of Verdesian Life Sciences
U.S., LLC, 1001 Winstead Dr., Suite 480, Cary, NC 27513. The petition
requested that 40 CFR part 180 be amended to establish an exemption
from the requirement of a tolerance for residues of L-PCA, when used as
a plant growth regulator on agricultural crops, turf, and ornamental
plants, in accordance with label directions and good agricultural
practices. That document referenced a summary of the petition prepared
by the petitioner, Verdesian Life Sciences U.S., LLC, which is
available in docket EPA-HQ-OPP-2018-0158 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. No substantive comments were received in response
to this Notice of Filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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. . .
.'' Additionally, FFDCA section 408(b)(2)(D) requires that 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.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. If EPA is
able to determine that a tolerance is not necessary to ensure that
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 L-PCA including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with L-PCA follows.
A. Toxicological Profile
L-PCA is derived from L-glutamic acid via an intramolecular
condensation reaction. L-PCA is naturally found in mammalian tissues.
L-PCA has a non-toxic mode of action and can effectively enhance
upregulation of the glutamine synthesis pathway. When applied to
plants, it has demonstrated effects, such as increased growth,
increased nodulation, and greater fresh weight. It also has seed
priming properties. L-PCA has a long history of use in consumer
products, including dietary supplements and cosmetic products.
L-PCA can be applied in various forms (free acids or salts), but it
releases a common moiety that is the pesticidally-active component and
serves as the basis for risk assessment and tolerance regulation. Since
L-PCA is a strong acid, buffered solutions will contain some salt form,
but not enough at any moment in time to be toxicologically relevant.
In the field, the above rationale continues to apply when active
ingredient is in solution. If the products dry out on plants and then
someone touches them, there would likely be some exposure from the salt
form, however, it will not change the toxicology since it would not
stay in the salt form once it was solubilized upon ingestion/contact
with water.
With regard to the overall toxicological profile, L-PCA is of low
toxicity. Acute toxicity data indicate that L-PCA is of low acute oral,
dermal, and inhalation toxicity. However, with its low pH (2), it is
likely corrosive. The available data suggest it is not a skin
sensitizer.
Studies from the open scientific literature on the sodium salt
analog, Na-PCA, were submitted to satisfy the 90-day oral for L-PCA.
The Na-PCA toxicity database is considered appropriate for use in L-PCA
risk assessment when EP formulations are buffered. There is an
expectation that EP formulations for use as plant growth regulators
will be buffered because unbuffered solutions will not be effective as
a plant growth regulator, i.e., unbuffered solutions would likely
destroy the plant due to the acidity of L-PCA. This is because buffered
L-PCA behaves similarly to Na-PCA. There is comparable acute toxicity
between the proposed EP formulations and Na-PCA. Further, both L-PCA
and Na-PCA are naturally occurring and are products of human
metabolism. Using a weight of the evidence (WOE) approach, these
studies allowed EPA to establish a no-observed-adverse-effect-level
(NOAEL) of 849 mg/kg/day for subchronic oral toxicity for L-PCA in
buffered end-use products.
For developmental toxicity, a non-guideline 1-generation
reproduction toxicity screening study was submitted on Na-PCA in lieu
of a developmental toxicity study. The study showed no treatment-
related effects on offspring body weights, body weight gains or on
post-implantation losses, mean litter size, numbers of live and dead
pups born, sex ratio, or the birth or survival indices. No gross or
microscopic pathology of the reproductive tract was seen, and
reproductive performance was not affected by treatment. While this
study is not a guideline developmental toxicity study, EPA has
determined that the screening study is acceptable to satisfy the
prenatal developmental toxicity data at this time for the specified
products. This decision is based on the fact that no observable
toxicity was produced at the limit dose
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level in this study and an effect would not be expected from
structurally related compounds.
EPA determined that 90-day inhalation toxicity and 90-day dermal
studies were not required to assess the risks from L-PCA for the
following reasons: (1) physical and chemical properties of the buffered
formulations of L-PCA are similar to those of Na-PCA; (2) estimated
margins of error (MOEs) are more than 10X the level of concern (LOC);
and (3) no irritation was observed in studies conducted using the
buffered end-use products.
The available data indicates that the active ingredient is non-
mutagenic.
B. Toxicological Points of Departure/Levels of Concern
Based on the toxicological profile, EPA did not identify any
toxicological endpoints of concern for L-PCA.
C. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water. No
toxicological endpoint of concern was identified for L-PCA, and
therefore, a quantitative assessment of dietary exposure is not
necessary. As part of its qualitative risk assessment for L-PCA, the
Agency considered the potential for dietary exposure to residues of the
chemical. EPA concludes that dietary (food and drinking water)
exposures are possible. However, due to the lack of a toxicological
endpoint, dietary risk is not of concern.
2. Non-dietary exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., textiles (clothing and diapers), carpets, swimming pools, and
hard surface disinfection on walls, floors, tables). There are
currently no proposed residential uses for this active ingredient,
therefore a residential exposure assessment is not necessary.
3. Cumulative effects from substances with a common mechanism of
toxicity. 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.'' EPA has not found that L-
PCA shares a common mechanism of toxicity with any other substances,
and it does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed L-PCA does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor. An FQPA safety factor is not required at this time
for L-PCA because there are no threshold effects; no dietary endpoints
have been selected based on the lack of human-relevant adverse effects
at limit doses in the 90-day oral toxicity study and prenatal
developmental toxicity study.
E. Aggregate Risk
Based on the available data and information, EPA has concluded that
a qualitative aggregate risk assessment is appropriate to support the
pesticidal use of L-PCA in buffered end-use products, and that risks of
concern are not anticipated from aggregate exposure to the substance in
this manner. This conclusion is based on the low toxicity of the active
ingredient and its salts, which release a common moiety that is the
basis for the risk assessment. Due to the lack of toxicity, EPA
concludes that there is no aggregate risk from exposure to L-PCA.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found within the September 20,
2022, document entitled ``Product Chemistry Review and Human Health
Risk Assessment for FIFRA Section 3 Registrations of (2S)-5-
Oxopyrrolidine-2-carboxylic Acid (L-PCA) Technical, containing 99.1% L-
PCA, VLS 2002-03, Containing 25.0% L-PCA and VLS 2002-03-0.10,
Containing 10.0% L-PCA.'' This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
IV. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
L-PCA.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Therefore, EPA is establishing an exemption for residues of L-PCA
in or on all food commodities when used as a plant growth regulator in
accordance with label directions and good agricultural practices.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance 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
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the
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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).
VIII. 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: August 4, 2023.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR part 180 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. Add Sec. 180.1404 to subpart D to read as follows:
Sec. 180.1404 (2S)-5-Oxopyrrolidine-2-carboxylic Acid (L-PCA);
exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the pesticide, (2S)-5-Oxopyrrolidine-2-carboxylic Acid (L-
PCA) in or on all food commodities when used as a plant growth
regulator in accordance with label directions and good agricultural
practices.
[FR Doc. 2023-17135 Filed 8-9-23; 8:45 am]
BILLING CODE 6560-50-P
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