(2S)-5-Oxopyrrolidine-2-carboxylic Acid (L-PCA); Exemption From the Requirement of a Tolerance, 54244-54247 [2023-17135]
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54244
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Rules and Regulations
TABLE 2—ATTAINMENT, MAINTENANCE, AND OTHER PLANS
Applicable
geographic or
nonattainment
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date
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Explanations
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Smoke Management Planning
Department of Natural Resources 2022
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Statewide ..........
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[FR Doc. 2023–16409 Filed 8–9–23; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of (2S)-5Oxopyrrolidine-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.
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SUMMARY:
This regulation is effective
August 10, 2023. Objections and
requests for hearings must be received
on or before October 10, 2023 and must
DATES:
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8/10/2023, [INSERT Federal Register CITATION]..
*
*
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 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
and docket access, visit https://
www.epa.gov/dockets.
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: BPPDFRNotices@
epa.gov.
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:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
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• 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 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–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:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
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Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Rules and Regulations
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-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
ddrumheller on DSK120RN23PROD with RULES1
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 https://
www.regulations.gov. 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
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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 nontoxic 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
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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 90day 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 noobserved-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 nonguideline 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.
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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
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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 https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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-Oxopyrrolidine2-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
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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).
ddrumheller on DSK120RN23PROD with RULES1
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:
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PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1404 to subpart D to read
as follows:
■
§ 180.1404 (2S)-5-Oxopyrrolidine-2carboxylic 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-Oxopyrrolidine2-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 73
Select Agent Determination
Concerning Coxiella burnetii Phase II,
Nine Mile Strain, Plaque Purified Clone
4 With Reversion to Wildtype cbu0533
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Determination.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), has determined
that an excluded attenuated strain,
Coxiella burnetii Phase II, Nine Mile
Strain, plaque purified clone 4, has, in
one instance, been shown to
spontaneously mutate when passaged in
vivo. The resulting mutant, C. burnetii
Phase II, Nine Mile Strain, plaque
purified clone 4 with reversion to
wildtype cbu0533, has enhanced
pathogenicity and virulence. Therefore,
C. burnetii Phase II, Nine Mile Strain,
plaque purified clone 4 with reversion
to wildtype cbu0533 is not an excluded
strain but is a select agent and subject
to the HHS select agent and toxin
regulations.
DATES: This determination is effective
August 10, 2023.
FOR FURTHER INFORMATION CONTACT:
Samuel S. Edwin Ph.D., Director,
Division of Select Agents and Toxins,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop H21–4, Atlanta, Georgia 30329,
Telephone: (404) 718–2000.
SUMMARY:
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54247
Coxiella
burnetti is a select agent that is
regulated pursuant to the HHS select
agent and toxin regulations (42 CFR part
73). C. burnetii is a gram-negative
intracellular bacterium that causes Q
Fever. Q Fever is a zoonotic disease that
causes flu-like symptoms in humans,
including fever, chills, fatigue, and
muscle pain. Humans become infected
when they are in close contact with
infected animal fluids and products.
The HHS select agent regulations (42
CFR part 73) established a process by
which an attenuated strain of a select
biological agent that does not have the
potential to pose a severe threat to
public health and safety may be
excluded from the requirements of the
regulations. On October 15, 2003, C.
burnetii Phase II, Nine Mile Strain,
plaque purified clone 4 was excluded
from HHS select agent regulations as it
does not pose a significant threat to
public health and safety (https://
selectagents.gov/sat/exclusions/
hhs.htm).
As set forth under 42 CFR 73.4(e)(2),
if an excluded attenuated strain is
subjected to any manipulation that
restores or enhances its virulence, the
resulting select agent will be subject to
the requirements of the regulations. On
March 20, 2023, an entity informed CDC
of a reversion whereby C. burnetii Phase
II, Nine Mile Strain, plaque purified
clone 4 spontaneously mutated. The C.
burnetii Phase II, Nine Mile Strain,
plaque purified clone 4 with reversion
to wildtype cbu0533 displayed
increased pathogenicity and virulence.
The entity stated that after the excluded
strain was injected into guinea pigs, a
spontaneous reversion occurred that
resulted in a mutant strain of the agent
and the guinea pigs subsequently
exhibited elevated fever and weight
loss. The genetic mutation that led to
the mutant strain was the reversion and
restoration of a deletion in the cbu0533
gene. CDC subject matter experts have
determined that this reversion in
cbu0533 restored virulence and
pathogenicity. Therefore, C. burnetii
Phase II, Nine Mile Strain, plaque
purified clone 4 with reversion to
wildtype cbu0533 is determined to be a
select agent and subject to 42 CFR part
73.
SUPPLEMENTARY INFORMATION:
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–16929 Filed 8–9–23; 8:45 am]
BILLING CODE 4163–18–P
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]]>Agencies
[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 [www.gpo.gov]
[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
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 and docket access, visit https://www.epa.gov/dockets.
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:
[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, 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:
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 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-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:
Federal eRulemaking Portal: https://www.regulations.gov.
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.
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, is available at https://www.epa.gov/dockets.
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 https://www.regulations.gov. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
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
