Ledprona (CAS# 2433753-68-3) for Use in or on Potato; Temporary Exemption From the Requirement of a Tolerance, 28427-28430 [2023-09486]
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Rules and Regulations
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TABLE 1 TO § 1236.58—TRANSFER METADATA TABLE—Continued
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Debra Steidel Wall,
Acting Archivist of the United States.
[FR Doc. 2023–09050 Filed 5–3–23; 8:45 am]
BILLING CODE 7515–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0932; FRL–10947–01–
OCSPP]
Ledprona (CAS# 2433753–68–3) for
Use in or on Potato; Temporary
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
temporary exemption from the
requirement of a tolerance for residues
of Ledprona (CAS# 2433753–68–3) in or
on potatoes when used in accordance
with the terms of Experimental Use
Permit (EUP) No. 94614–EUP–1.
GreenLight Bioscience, Inc. submitted a
petition to EPA under the Federal Food,
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SUMMARY:
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16:25 May 03, 2023
Jkt 259001
Drug, and Cosmetic Act (FFDCA) for a
temporary exemption from the
requirement of a tolerance for residues
of Ledprona on all raw agricultural
products and food products. After
reviewing the petition and supporting
data, the Agency has limited the
temporary tolerance exemption to
residues of Ledprona on potatoes only.
This regulation eliminates the need to
establish a maximum permissible level
for residues of Ledprona in or on
potatoes. This temporary tolerance
exemption expires on April 30, 2025.
DATES: This regulation is effective May
4, 2023. Objections and requests for
hearings must be received on or before
July 3, 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).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–20–2022–0932,
is available at https://
www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public
Docket (OPP Docket) in the
Environmental Protection Agency
ADDRESSES:
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Requirement level
Mandatory.
Mandatory.
Mandatory.
Mandatory if access restriction exists.
Mandatory.
Mandatory if use restriction
exists.
Mandatory.
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
telephone number for the OPP Docket is
(202) 566–1744. Please review the
visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Frank Ellis, Biopesticides and Pollution
Prevention Division (7511M), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 328–
3074; 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, or
pesticide manufacturer. The following
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Rules and Regulations
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).
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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–2022–0932 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 July 3, 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–
20–2022–0932, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
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16:25 May 03, 2023
Jkt 259001
• 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.
II. Background
In the Federal Register of January 3,
2023 (88 FR 38) (FRL–9410–08–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 tolerance petition (2G9024) by
GreenLight Bioscience, Inc., 200 Boston
Ave., Suite 1000, Medford, MA 02155.
The petitioner requested that 40 CFR
part 180 be amended by establishing a
temporary exemption from the
requirement of a tolerance for residues
of Ledprona on all raw agricultural
products and food products. That
document referenced a summary of the
petition prepared by the petitioner
GreenLight Biosciences, Inc., which is
available in the docket at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the petition and
associated data and in accordance with
its authority under FFDCA section
408(d)(4)(A)(i) and (r), EPA is
establishing a temporary exemption
from the requirement of a tolerance for
residues of Ledprona in or on potatoes
only when used in accordance with the
terms of Experimental Use Permit No.
94614–EUP–1. The EUP is authorized
for testing on potatoes only; therefore,
the Agency has limited the temporary
tolerance to potatoes alone.
III. Final Rule
A. EPA’s Safety Determination
Section 408(r) of FFDCA authorizes
EPA to establish a temporary exemption
from the requirement of a tolerance for
residues covered by an experimental use
permit issued under the Federal
Insecticide, Fungicide, and Rodenticide
Act. That section states that the
provisions of section 408(c)(2) of
FFDCA apply to exemptions issued
under FFDCA section 408(r). 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
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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 or tolerance exemption 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 EPA
consider ‘‘available information
concerning the cumulative effects of [a
particular pesticide’s] . . . residues and
other substances that have a common
mechanism of toxicity.’’
EPA evaluated the available toxicity
and exposure data for Ledprona and
considered its validity, completeness,
and reliability, as well as the
relationship of this information to
human risk. In summary, dietary risk
from the use of Ledprona is considered
negligible because dietary exposure to
residues of Ledprona in or on food or
feed is expected to be negligible and no
adverse effects were observed in toxicity
testing. A full summary of the data upon
which EPA relied and its risk
assessments based on that data can be
found within the document entitled,
‘‘Human health and product
characterization for the Experimental
Use Permit application for CalanthaTM,
containing 0.8% of the new active
ingredient ‘Ledprona’ dsRNA for use on
potatoes and associated petition to
establish a temporary tolerance
exemption’’ (Human Health Risk
Assessment). This document, as well as
other relevant information, is available
in the docket for this action as described
under ADDRESSES.
Available data have demonstrated
that, with regard to humans, Ledprona
presents no adverse effects of concern
and exposure to the active ingredient
will be insignificant. Ledprona consists
of double-stranded ribonucleic acid
(dsRNA) that induces mortality of the
Colorado potato beetle (Leptinotarsa
decemlineata) via a gene silencing mode
of action. When dsRNA is applied, it
causes the inhibition (or silencing) of
the gene product, messenger RNA
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Rules and Regulations
(mRNA), preventing the translation of
the mRNA to proteins. Ledprona dsRNA
is targets the Proteasome subunit beta
type-5 (PSMB5) mRNA sequence in the
Colorado potato beetle. PSMB5 mRNA
encodes a protein that regulates proper
folding of other proteins in the Colorado
potato beetle. Once Ledprona is ingested
by the Colorado potato beetle, over time
the lack of PSMB5 mRNA leads to the
reduction of the PSMB5 protein and
ultimately causes mortality.
Dietary exposure to Ledprona through
residues of the active ingredient in or on
food or feed as well as in drinking water
is expected to be negligible. As detailed
in the Human Health Risk Assessment,
dietary exposure to Ledprona is
anticipated to be limited for the
following reasons: (1) The EUP is
limited to foliar application on potatoes.
Underground tubers would not be
directly exposed to Ledprona, so
consumption of residues on potatoes is
expected to be limited; (2) Once
applied, Ledprona is expected to
undergo rapid degradation due to
microbial activity; (3) Submitted data
show that Ledprona rapidly degrades in
the mammalian gut; and (4) Mammals
possess physiological barriers (i.e.,
nucleases in saliva and gastrointestinal
tract, acidic conditions in the stomach,
presence of multiple membrane barriers)
that prevent uptake of dsRNA. Ledprona
is expected to degrade within 20–25
hours after application at the EUP label
rates in microbially rich environments
(e.g., soil) Further, Ledprona rapidly
degrades in simulated gastric fluids
(within 10 minutes in simulated
intestinal fluid and within 20 minutes
in simulated gastric fluid) and degrades
at similar rates as RNA extracted from
plants. This information allows EPA to
rely on a well-established history of
exposure to RNA molecules via food.
These data indicate that dietary
exposure from the use of this active
ingredient is considered negligible.
In addition to the lack of exposure
described above, submitted acute oral
toxicity studies demonstrated a lack of
hazard of Ledprona to the mammalian
surrogate species, rats, in vivo. A
bioinformatic analysis was conducted to
evaluate the likelihood of off-target
effects of the Ledprona dsRNA in
humans in silico, by computer analysis
of Ledprona RNA segments. The
analysis represents the potential for
Ledprona dsRNA 21-mers (21
nucleotide segments) to match RNA
segments in the human transcriptome
(i.e., the set of all human RNA
transcripts, including coding and noncoding). The analysis identified three
Ledprona 21-mers which display the
potential to match and subsequently
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16:25 May 03, 2023
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silence target mRNAs in silico. The
three 21-mers are predicted to overlap
with non-coding RNAs. However, the
analysis assumes that the 21-mers
identified would be capable of
bypassing physiological barriers to
access the cell nucleus in sufficient
quantities. As described above,
submitted data show that Ledprona
rapidly degrades in the mammalian gut,
and the physiological barriers present in
mammals (i.e., nucleases in saliva and
gastrointestinal tract, acidic conditions
in the stomach, presence of multiple
membrane barriers) impede the uptake
of dsRNA, therefore negating any
silencing potential of the 21-mer partial
matches via the oral route of exposure.
The potential for residential exposure
is highly unlikely because there are no
residential uses proposed for the EUP
under which Ledprona would be
applied. Non-occupational exposure is
unlikely because applications will occur
in experimental plots generally not
accessible to bystanders. However,
should bystander exposure occur postapplication (i.e., contact with treated
foliage), adverse effects are not expected
since Ledprona is non-toxic through the
dermal route of exposure.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ No risk of
cumulative toxicity/effects from
Ledprona have been identified as no
toxicity has been shown for Ledprona in
the submitted studies. Therefore, EPA
has not assumed that Ledprona has a
common mechanism of toxicity with
other substances.
Although FFDCA section 408(b)(2)(C)
provides for an additional tenfold
margin of safety for infants and children
in the case of threshold effects, EPA has
determined that there are no such
effects due to the lack of toxicity of
Ledprona. As a result, an additional
margin of safety for the protection of
infants and children is unnecessary.
Based upon its evaluation, 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 Ledprona in or on potatoes.
This includes all anticipated dietary
exposures for which there is reliable
information. The Agency has arrived at
this conclusion based on the rapid
degradation of the active ingredient in
environmental and biological
conditions, mammalian physiological
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28429
barriers limiting the uptake of dsRNA,
and the lack of effects observed in
toxicity testing.
B. Analytical Enforcement Methodology
EPA has determined that 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.
C. Conclusion
Based upon its evaluation in the
Human Health Risk Assessment, EPA
concludes that there is a reasonable
certainty that no harm will result to the
U.S. population, including infants and
children, from aggregate exposure to
residues of Ledprona in or on potatoes.
Therefore, a temporary exemption from
the requirement of a tolerance is
established for residues of Ledprona in
or on potatoes when used in accordance
with the terms of Experimental Use
Permit No. 94614–EUP–1.
IV. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption 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 exemption 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.
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Rules and Regulations
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).
V. Congressional Review Act
List of Subjects in 40 CFR Part 180
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Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 1, 2023.
Frank Ellis,
Acting Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR part
180 as follows:
16:25 May 03, 2023
Jkt 259001
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1403 to subpart D to read
as follows:
■
§ 180.1403 Ledprona; temporary
exemption from the requirement of a
tolerance.
A temporary exemption from the
requirement of a tolerance is established
for residues of Ledprona in or on potato
when used in accordance with the terms
of Experimental Use Permit No. 94614–
EUP–1. This temporary exemption from
the requirement of a tolerance expires
on April 30, 2025.
[FR Doc. 2023–09486 Filed 5–3–23; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 635
[Docket No. 220919–0193]
RTID 0648–XC917
Atlantic Highly Migratory Species;
Atlantic Bluefin Tuna Fisheries;
Angling Category Retention Limit
Adjustment
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; retention limit
adjustment.
AGENCY:
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).
VerDate Sep<11>2014
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
NMFS has determined, based
on consideration of the regulatory
determination criteria regarding
inseason adjustments, that the Atlantic
bluefin tuna (BFT) daily retention limit
that applies to Highly Migratory Species
(HMS) Angling and HMS Charter/
Headboat permitted vessels (when
fishing recreationally for BFT) should be
adjusted for the remainder of 2023.
NMFS is adjusting the Angling category
BFT daily retention limit from the
default of one school, large school, or
small medium BFT to: two school BFT
and one large school/small medium BFT
per vessel per day/trip for private
vessels with HMS Angling permits;
three school BFT and one large school/
small medium BFT per vessel per day/
trip for charter boat vessels with HMS
Charter/Headboat permits when fishing
recreationally; and six school BFT and
SUMMARY:
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two large school/small medium BFT per
vessel per day/trip for headboat vessels
with HMS Charter/Headboat permits
when fishing recreationally. These
retention limits are effective in all areas,
except for the Gulf of Mexico, where
targeted fishing for BFT is prohibited.
DATES: Effective May 3, 2023 through
December 31, 2023.
FOR FURTHER INFORMATION CONTACT: Lisa
Crawford, lisa.crawford@noaa.gov, 301–
427–8503; Larry Redd, Jr., larry.redd@
noaa.gov, 301–427–8503; Nicholas
Velseboer, nicholas.velseboer@
noaa.gov, 978–281–9260.
SUPPLEMENTARY INFORMATION: Atlantic
HMS fisheries, including BFT fisheries,
are managed under the authority of the
Atlantic Tunas Convention Act (ATCA;
16 U.S.C. 971 et seq.) and the
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act; 16 U.S.C. 1801
et seq.). The 2006 Consolidated Atlantic
HMS Fishery Management Plan (FMP)
and its amendments are implemented
by regulations at 50 CFR part 635.
Section 635.27 divides the U.S. BFT
quota recommended by the
International Commission for the
Conservation of Atlantic Tunas (ICCAT)
and as implemented by the United
States among the various domestic
fishing categories, per the allocations
established in the 2006 Consolidated
Atlantic HMS FMP and its amendments.
NMFS is required under the MagnusonStevens Act to provide U.S. fishing
vessels with a reasonable opportunity to
harvest quotas under relevant
international fishery agreements such as
the ICCAT Convention, which is
implemented domestically pursuant to
ATCA.
As described in § 635.27(a), the
current baseline U.S. BFT quota is
1,316.14 metric tons (mt) (not including
the 25-mt ICCAT allocated to the United
States to account for bycatch of BFT in
pelagic longline fisheries in the
Northeast Distant Gear Restricted Area).
The Angling category baseline quota is
297.4 mt. This baseline quota is further
subdivided into subquotas by size class
(see Table 1) as follows: 134.1 mt for
school BFT, 154.1 mt for large school/
small medium BFT, and 9.2 mt for large
medium/giant BFT. Large school and
small medium BFT traditionally have
been managed as one size class, i.e., a
limit of one large school/small medium
BFT (measuring 47 to less than 73
inches, 119 to less than 150 cm).
Similarly, large medium and giant BFT
traditionally have been managed as one
size class that is also known as the
‘‘trophy’’ class. Currently, the default
Angling category daily retention limit of
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]]>Agencies
[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Rules and Regulations]
[Pages 28427-28430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09486]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0932; FRL-10947-01-OCSPP]
Ledprona (CAS# 2433753-68-3) for Use in or on Potato; Temporary
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of Ledprona (CAS# 2433753-68-3)
in or on potatoes when used in accordance with the terms of
Experimental Use Permit (EUP) No. 94614-EUP-1. GreenLight Bioscience,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA) for a temporary exemption from the requirement of
a tolerance for residues of Ledprona on all raw agricultural products
and food products. After reviewing the petition and supporting data,
the Agency has limited the temporary tolerance exemption to residues of
Ledprona on potatoes only. This regulation eliminates the need to
establish a maximum permissible level for residues of Ledprona in or on
potatoes. This temporary tolerance exemption expires on April 30, 2025.
DATES: This regulation is effective May 4, 2023. Objections and
requests for hearings must be received on or before July 3, 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-20-2022-0932, 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 telephone number for the OPP Docket is (202) 566-
1744. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Frank Ellis, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 328-3074; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following
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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-2022-0932 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
July 3, 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-20-2022-0932, by one
of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
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
In the Federal Register of January 3, 2023 (88 FR 38) (FRL-9410-08-
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 tolerance
petition (2G9024) by GreenLight Bioscience, Inc., 200 Boston Ave.,
Suite 1000, Medford, MA 02155. The petitioner requested that 40 CFR
part 180 be amended by establishing a temporary exemption from the
requirement of a tolerance for residues of Ledprona on all raw
agricultural products and food products. That document referenced a
summary of the petition prepared by the petitioner GreenLight
Biosciences, Inc., which is available in the docket at https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the petition and associated data and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i) and
(r), EPA is establishing a temporary exemption from the requirement of
a tolerance for residues of Ledprona in or on potatoes only when used
in accordance with the terms of Experimental Use Permit No. 94614-EUP-
1. The EUP is authorized for testing on potatoes only; therefore, the
Agency has limited the temporary tolerance to potatoes alone.
III. Final Rule
A. EPA's Safety Determination
Section 408(r) of FFDCA authorizes EPA to establish a temporary
exemption from the requirement of a tolerance for residues covered by
an experimental use permit issued under the Federal Insecticide,
Fungicide, and Rodenticide Act. That section states that the provisions
of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA
section 408(r). 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 or tolerance
exemption 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 EPA consider ``available information
concerning the cumulative effects of [a particular pesticide's] . . .
residues and other substances that have a common mechanism of
toxicity.''
EPA evaluated the available toxicity and exposure data for Ledprona
and considered its validity, completeness, and reliability, as well as
the relationship of this information to human risk. In summary, dietary
risk from the use of Ledprona is considered negligible because dietary
exposure to residues of Ledprona in or on food or feed is expected to
be negligible and no adverse effects were observed in toxicity testing.
A full summary of the data upon which EPA relied and its risk
assessments based on that data can be found within the document
entitled, ``Human health and product characterization for the
Experimental Use Permit application for CalanthaTM,
containing 0.8% of the new active ingredient `Ledprona' dsRNA for use
on potatoes and associated petition to establish a temporary tolerance
exemption'' (Human Health Risk Assessment). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
Available data have demonstrated that, with regard to humans,
Ledprona presents no adverse effects of concern and exposure to the
active ingredient will be insignificant. Ledprona consists of double-
stranded ribonucleic acid (dsRNA) that induces mortality of the
Colorado potato beetle (Leptinotarsa decemlineata) via a gene silencing
mode of action. When dsRNA is applied, it causes the inhibition (or
silencing) of the gene product, messenger RNA
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(mRNA), preventing the translation of the mRNA to proteins. Ledprona
dsRNA is targets the Proteasome subunit beta type-5 (PSMB5) mRNA
sequence in the Colorado potato beetle. PSMB5 mRNA encodes a protein
that regulates proper folding of other proteins in the Colorado potato
beetle. Once Ledprona is ingested by the Colorado potato beetle, over
time the lack of PSMB5 mRNA leads to the reduction of the PSMB5 protein
and ultimately causes mortality.
Dietary exposure to Ledprona through residues of the active
ingredient in or on food or feed as well as in drinking water is
expected to be negligible. As detailed in the Human Health Risk
Assessment, dietary exposure to Ledprona is anticipated to be limited
for the following reasons: (1) The EUP is limited to foliar application
on potatoes. Underground tubers would not be directly exposed to
Ledprona, so consumption of residues on potatoes is expected to be
limited; (2) Once applied, Ledprona is expected to undergo rapid
degradation due to microbial activity; (3) Submitted data show that
Ledprona rapidly degrades in the mammalian gut; and (4) Mammals possess
physiological barriers (i.e., nucleases in saliva and gastrointestinal
tract, acidic conditions in the stomach, presence of multiple membrane
barriers) that prevent uptake of dsRNA. Ledprona is expected to degrade
within 20-25 hours after application at the EUP label rates in
microbially rich environments (e.g., soil) Further, Ledprona rapidly
degrades in simulated gastric fluids (within 10 minutes in simulated
intestinal fluid and within 20 minutes in simulated gastric fluid) and
degrades at similar rates as RNA extracted from plants. This
information allows EPA to rely on a well-established history of
exposure to RNA molecules via food. These data indicate that dietary
exposure from the use of this active ingredient is considered
negligible.
In addition to the lack of exposure described above, submitted
acute oral toxicity studies demonstrated a lack of hazard of Ledprona
to the mammalian surrogate species, rats, in vivo. A bioinformatic
analysis was conducted to evaluate the likelihood of off-target effects
of the Ledprona dsRNA in humans in silico, by computer analysis of
Ledprona RNA segments. The analysis represents the potential for
Ledprona dsRNA 21-mers (21 nucleotide segments) to match RNA segments
in the human transcriptome (i.e., the set of all human RNA transcripts,
including coding and non-coding). The analysis identified three
Ledprona 21-mers which display the potential to match and subsequently
silence target mRNAs in silico. The three 21-mers are predicted to
overlap with non-coding RNAs. However, the analysis assumes that the
21-mers identified would be capable of bypassing physiological barriers
to access the cell nucleus in sufficient quantities. As described
above, submitted data show that Ledprona rapidly degrades in the
mammalian gut, and the physiological barriers present in mammals (i.e.,
nucleases in saliva and gastrointestinal tract, acidic conditions in
the stomach, presence of multiple membrane barriers) impede the uptake
of dsRNA, therefore negating any silencing potential of the 21-mer
partial matches via the oral route of exposure.
The potential for residential exposure is highly unlikely because
there are no residential uses proposed for the EUP under which Ledprona
would be applied. Non-occupational exposure is unlikely because
applications will occur in experimental plots generally not accessible
to bystanders. However, should bystander exposure occur post-
application (i.e., contact with treated foliage), adverse effects are
not expected since Ledprona is non-toxic through the dermal route of
exposure.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' No risk of cumulative toxicity/effects
from Ledprona have been identified as no toxicity has been shown for
Ledprona in the submitted studies. Therefore, EPA has not assumed that
Ledprona has a common mechanism of toxicity with other substances.
Although FFDCA section 408(b)(2)(C) provides for an additional
tenfold margin of safety for infants and children in the case of
threshold effects, EPA has determined that there are no such effects
due to the lack of toxicity of Ledprona. As a result, an additional
margin of safety for the protection of infants and children is
unnecessary.
Based upon its evaluation, 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 Ledprona
in or on potatoes. This includes all anticipated dietary exposures for
which there is reliable information. The Agency has arrived at this
conclusion based on the rapid degradation of the active ingredient in
environmental and biological conditions, mammalian physiological
barriers limiting the uptake of dsRNA, and the lack of effects observed
in toxicity testing.
B. Analytical Enforcement Methodology
EPA has determined that 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.
C. Conclusion
Based upon its evaluation in the Human Health Risk Assessment, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Ledprona in or on potatoes. Therefore, a
temporary exemption from the requirement of a tolerance is established
for residues of Ledprona in or on potatoes when used in accordance with
the terms of Experimental Use Permit No. 94614-EUP-1.
IV. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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 exemption 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.
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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).
V. 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: May 1, 2023.
Frank Ellis,
Acting Director, Biopesticides and Pollution Prevention Division,
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. 180.1403 to subpart D to read as follows:
Sec. 180.1403 Ledprona; temporary exemption from the requirement of a
tolerance.
A temporary exemption from the requirement of a tolerance is
established for residues of Ledprona in or on potato when used in
accordance with the terms of Experimental Use Permit No. 94614-EUP-1.
This temporary exemption from the requirement of a tolerance expires on
April 30, 2025.
[FR Doc. 2023-09486 Filed 5-3-23; 8:45 am]
BILLING CODE 6560-50-P
