BLB2 and AMR3 Proteins in Potato; Temporary Exemption From the Requirement of a Tolerance, 31649-31652 [2024-08801]
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Rules and Regulations
PART 62—APPROVAL AND
PROMULGATION OF STATE PLANS
FOR DESIGNATED FACILITIES AND
POLLUTANTS
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for part 62
continues to read as follows:
[EPA–HQ–OPP–2024–0052; FRL–11896–01–
OCSPP]
I. General Information
Authority: 42 U.S.C. 7401 et seq.
BLB2 and AMR3 Proteins in Potato;
Temporary Exemption From the
Requirement of a Tolerance
Subpart FF—New Jersey
■
2. Amend § 62.7605, by adding
paragraphs (e) through (h) to read as
follows:
AGENCY:
§ 62.7605 Identification of plan—
delegation of authority.
SUMMARY:
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
*
*
*
*
(e) Letter from the New Jersey
Department of Environmental Protection
(NJDEP), submitted May 8, 2023,
requested delegation of authority from
EPA to implement and enforce the
Federal Plan Requirements for existing
Municipal Solid Waste Landfills. The
Federal plan will be administered by
both the NJDEP and the EPA, pursuant
to ‘‘Federal Plan Requirements for
Municipal Solid Waste (MSW) Landfills
That Commenced Construction On or
Before July 17, 2014, and Have Not Been
Modified or Reconstructed Since July
17, 2014’’ 40 CFR 62.16710–62.16730.
(f) Identification of sources. The
Existing MSW Landfills Federal Plan
applies to each municipal solid waste
landfill that meets the following criteria:
(1) Commenced construction,
reconstruction, or modification on or
before July 17, 2014.
(2) Accepted waste at any time since
November 8, 1987, or has additional
capacity for future waste deposition.
(g) On November 21, 2023, the NJDEP
Assistant Commissioner signed a
Memorandum of Agreement (MoA)
concerning the Delegation of Authority
of the Federal Plan for Existing
Municipal Solid Waste Landfills to the
New Jersey Department of
Environmental Protection by the United
States Environmental Protection
Agency. On November 28, 2023, the
EPA Region 2 Regional Administrator
signed the MoA, therefore agreeing to
the terms and conditions of the MoA
and accepting responsibility to enforce
and implement the policies,
responsibilities, and procedures for
existing MSW landfills.
(h) The delegation became fully
effective on November 28, 2023, the
date the MoA was signed by the EPA
Region 2 Regional Administrator.
[FR Doc. 2024–08737 Filed 4–24–24; 8:45 am]
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1400; email address: BPPDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
40 CFR Part 174
■
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31649
This regulation amends and
extends a temporary exemption from the
requirement of a tolerance for residues
of the BLB2 and AMR3 proteins in
potato, when used as a plantincorporated protectant (PIP) in
accordance with the terms of
Experimental Use Permit (EUP) No.
8971–EUP–3. J.R. Simplot Company,
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the temporary
tolerance exemption. This regulation
eliminates the need under FFDCA to
establish a maximum permissible level
for residues of BLB2 and AMR3
proteins. The temporary tolerance
exemption expires on March 31, 2025.
DATES: This regulation is effective April
25, 2024. Objections and requests for
hearings must be received on or before
June 24, 2024, 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–2024–0052, 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 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:
Madison Le, Biopesticides and Pollution
Prevention Division (7511M), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (202) 566–
ADDRESSES:
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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
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 174
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–2024–0052 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 June
24, 2024. 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–
2024–0052, by one of the following
methods:
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25APR1
31650
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Rules and Regulations
• 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-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 February
29, 2024 (89 FR 14795) (FRL–11682–01–
OCSPP), EPA issued notice pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (3F9098) by
J.R. Simplot Company, 5369 W. Irving
Street, Boise, ID 83706. The petition
requested that 40 CFR part 174 be
amended to extend a temporary
exemption from the requirement of a
tolerance for plant-incorporated
protectants BLB2 and AMR3 proteins in
potato from March 31, 2024, to March
31, 2025. That document referenced a
summary of the petition prepared by the
petitioner J.R. Simplot Company, which
is available in the docket via https://
www.regulations.gov. There were no
comments received in response to the
Notice of Filing.
III. Final Rule
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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
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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, among other factors,
‘‘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 on BLB2 and AMR3
proteins and considered its validity,
completeness, and reliability, as well as
the relationship of this information to
human risk. In summary, the available
data does not indicate any adverse
effects due to toxicity or allergenicity of
the BLB2 and AMR3 proteins. 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 ‘‘Review of the
Application for an Experimental Use
Permit for Gen 3 Potatoes expressing
transgenic R-proteins BLB2, AMR3 and
VNT1, PVY Coat Protein Hairpin RNA
and inert ingredient StmALS and
associated FFDCA Petitions for the
Temporary Exemption from a Tolerance
for AMR3 and BLB2, as well as FFDCA
Petition for the Exemption from a
Tolerance for StmALS’’ (Human Health
Risk Assessment). This document,
which was prepared in support of the
original temporary exemption from the
requirement of a tolerance for residues
of the BLB2 and AMR3 proteins in
potato, continues to support this
amendment and extension of the
tolerance exemption. The Human
Health Risk Assessment, 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, BLB2 and
AMR3 proteins are not anticipated to be
toxic or allergenic via any reasonably
foreseeable route of exposure. The
plant-incorporated protectant (PIP)
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active ingredients are resistance (‘‘R’’)
proteins that confer protection against
potato pathogens by directly or
indirectly recognizing pathogensecreted effector proteins. This
recognition leads to the activation of the
hypersensitive response, which is a
form of programmed cell death
characterized by cytoplasmic shrinkage,
chromatin condensation, mitochondrial
swelling, vacuolization and chloroplast
disruption. This hypersensitive
response pathway involves immune
signaling triggered by R proteins that is
specific to plants; activated R-proteins
cannot trigger cell death in mammals.
Thus, BLB2 and AMR3 proteins do not
have a toxic mechanism of action, but
instead activate signaling cascades
within the plant which invoke the plant
cell death pathway to prevent growth
and spread of the pathogen.
There is likely to be dietary exposure
to BLB2 and AMR3 through
consumption of potato-derived foods
containing the proteins. However, the
Agency has concluded that any
potential dietary risk from the use of
BLB2 and AMR3 proteins to human
health is considered negligible for the
following reasons. (1) As described
above, the mode-of-action of BLB2 and
AMR3 is specific to plants and does not
affect mammalian cells. (2) Both the
BLB2 and AMR3 proteins are expressed
at extremely low levels in potato, which
indicates very low human exposure to
the proteins through the consumption of
BLB2- and AMR3-expressing potatoes.
(3) Bioinformatics analyses of BLB2 and
AMR3 proteins revealed no homology
with known toxins or allergens. (4) The
source organisms for the active
ingredients, Solanum bulbocastanum
(BLB2) and Solanum americanum
(AMR3), are not known as allergens. (5)
Both proteins have a history of safe use.
BLB2 originates from S. bulbocastanum
(ornamental nightshade), a close potato
relative that has 82% sequency
similarity with the tomato gene Mi-1,
which has a history of safe use since
tomatoes have been consumed by
humans for hundreds of years.
Furthermore, the BLB2 protein is
present in two Solanum tuberosum
potato varieties (Toluca and Bionica)
that have been conventionally bred and
cultivated for food use in Europe. AMR3
originates from S. americanum
(American black nightshade) which is
cultivated for medicinal and food use,
and as part of breeding programs for
improved nutrition. Although some
members of the Solanum genus have
toxicity, these effects are caused by
glycoalkaloids, which can cause toxicity
even in the common potato, Solanum
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tuberosum. Neither BLB2 nor AMR3 are
glycoalkaloids; instead, they belong to a
large family of R-proteins found
throughout the plant kingdom. There
are hundreds to thousands of R-proteins
in S. tuberosum and other crops which
have a long history of safe consumption.
Oral exposure from ingestion of
drinking water is unlikely because BLB2
and AMR3 proteins are present at very
low levels within the plant cells. If
AMR3 and BLB2 do enter the water
column, they are expected to degrade
rapidly in the presence of soil microbes,
or upon normal communal watertreatment procedures. In addition, there
is unlikely to be residential or nonoccupational exposure given that the
active ingredients are plantincorporated protectants in potato.
Therefore, the only possible route of
non-occupational exposure, other than
dietary, is via handling of the plants and
plant products. However, BLB2 and
AMR3 proteins are present in the
transformed potato tissues at levels
below the level of detection, resulting in
minimal to negligible exposure.
Furthermore, there are no risks
associated with these exposure routes
because bioinformatics analysis and the
history of safe use have shown that the
proteins are not toxic or allergenic.
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 and
allergenicity for these PIP active
ingredients. 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 the BLB2 and AMR3
proteins in potatoes. This includes all
anticipated dietary exposures and all
other exposures for which there is
reliable information. The Agency has
arrived at this conclusion based on the
mode-of-action, history of safe use, and
lack of toxicity and allergenicity for the
BLB2 and AMR3 proteins in potato.
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B. Analytical Enforcement Methodology
EPA has determined that an analytical
method is not required for enforcement
purposes since the Agency is
establishing a temporary exemption
from the requirement of a tolerance
without any numerical limitation.
Nonetheless, the petitioner submitted a
reverse transcription-quantitative
polymerase chain reaction (RT-qPCR)
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method for detection of BLB2 and
AMR3 in transformed leaves and tubers.
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 BLB2 and ARM3 proteins in
potatoes. Therefore, the expiration date
for the temporary exemption from the
requirement of a tolerance for residues
of BLB2 and AMR3 proteins in potato,
when used as a plant-incorporated
protectant in accordance with the terms
of Experimental Use Permit No. 8971–
EUP–3, is extended from March 31,
2024, to March 31, 2025.
IV. Statutory and Executive Order
Reviews
This action modifies an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to EPA.
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 action,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes. As a
result, this action does not alter the
relationships or distribution of power
and responsibilities established by
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31651
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA 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, EPA 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
EPA’s 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 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 18, 2024.
Madison Le,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 174—PROCEDURES AND
REQUIREMENTS FOR PLANTINCORPORATED PROTECTANTS
1. The authority citation for part 174
continues to read as follows:
■
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
321(q), 346a and 371.
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Rules and Regulations
2. Revise and republish § 174.545 to
subpart W to read as follows:
■
§ 174.545 BLB2 and AMR3 proteins in
potato; temporary exemption from the
requirement of a tolerance.
Residues of BLB2 and AMR3 proteins
in potato are temporarily exempt from
the requirement of a tolerance when
used as a plant-incorporated protectant
in potato in accordance with the terms
of Experimental Use Permit No. 8917–
EUP–3. This temporary exemption from
the requirement of a tolerance expires
on March 31, 2025.
[FR Doc. 2024–08801 Filed 4–24–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2021–0681; FRL–11878–01–
OCSPP]
Escherichia coli Strain K–12 P678–54
Micelles in Pesticide Formulations;
Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Escherichia coli
strain K–12 P678–54 micelles (also
known as E. coli K–12 derived micelles)
when used as an inert ingredient
(encapsulation of active ingredient) on
growing crops and raw agricultural
commodities pre- and post-harvest.
AgroSpheres, Inc., submitted a petition
to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of E. coli K–12 derived
micelles, when used in accordance with
the terms of those exemptions.
DATES: This regulation is effective April
25, 2024. Objections and requests for
hearings must be received on or before
June 24, 2024 and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0681, 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
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SUMMARY:
VerDate Sep<11>2014
15:53 Apr 24, 2024
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. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
Jkt 262001
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
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–2021–0681 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 June
24, 2024. Addresses for mail and hand
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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–
2021–0681, 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-sendcomments-epa-dockets#express.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of October 21,
2021 (86 FR 58239) (FRL–8793–04–
OCSPP), EPA issued a document
pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a
pesticide petition (PP IN–11585) by
AgroSpheres, Inc., 1180 Seminole Trail,
Charlottesville, VA, USA, 22901. The
petition requested that 40 CFR be
amended by establishing an exemption
from the requirement of a tolerance for
residues of E. coli K–12 derived
micelles, when used as an inert
ingredient (encapsulation of active
ingredient) in pesticide formulations
applied to growing crops or raw
agricultural commodities pre- and postharvest under 40 CFR 180.910. That
document referenced a summary of the
petition prepared by AgroSpheres, Inc.,
1180 Seminole Trail, Charlottesville,
VA, USA, 22901, the petitioner, which
is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
E:\FR\FM\25APR1.SGM
25APR1
Agencies
[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Rules and Regulations]
[Pages 31649-31652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08801]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2024-0052; FRL-11896-01-OCSPP]
BLB2 and AMR3 Proteins in Potato; Temporary Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends and extends a temporary exemption from
the requirement of a tolerance for residues of the BLB2 and AMR3
proteins in potato, when used as a plant-incorporated protectant (PIP)
in accordance with the terms of Experimental Use Permit (EUP) No. 8971-
EUP-3. J.R. Simplot Company, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary
tolerance exemption. This regulation eliminates the need under FFDCA to
establish a maximum permissible level for residues of BLB2 and AMR3
proteins. The temporary tolerance exemption expires on March 31, 2025.
DATES: This regulation is effective April 25, 2024. Objections and
requests for hearings must be received on or before June 24, 2024, 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-2024-0052, 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 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: Madison Le, Biopesticides and
Pollution Prevention Division (7511M), 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, 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 174 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-2024-0052 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
June 24, 2024. 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-2024-0052, by one of
the following methods:
[[Page 31650]]
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 February 29, 2024 (89 FR 14795) (FRL-
11682-01-OCSPP), EPA issued notice pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (3F9098) by J.R. Simplot Company, 5369 W. Irving Street,
Boise, ID 83706. The petition requested that 40 CFR part 174 be amended
to extend a temporary exemption from the requirement of a tolerance for
plant-incorporated protectants BLB2 and AMR3 proteins in potato from
March 31, 2024, to March 31, 2025. That document referenced a summary
of the petition prepared by the petitioner J.R. Simplot Company, which
is available in the docket via https://www.regulations.gov. There were
no comments received in response to the Notice of Filing.
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, among other factors,
``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 on BLB2 and
AMR3 proteins and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. In summary, the available data does not indicate any adverse
effects due to toxicity or allergenicity of the BLB2 and AMR3 proteins.
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 ``Review of the Application for an Experimental Use Permit for
Gen 3 Potatoes expressing transgenic R-proteins BLB2, AMR3 and VNT1,
PVY Coat Protein Hairpin RNA and inert ingredient StmALS and associated
FFDCA Petitions for the Temporary Exemption from a Tolerance for AMR3
and BLB2, as well as FFDCA Petition for the Exemption from a Tolerance
for StmALS'' (Human Health Risk Assessment). This document, which was
prepared in support of the original temporary exemption from the
requirement of a tolerance for residues of the BLB2 and AMR3 proteins
in potato, continues to support this amendment and extension of the
tolerance exemption. The Human Health Risk Assessment, 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, BLB2
and AMR3 proteins are not anticipated to be toxic or allergenic via any
reasonably foreseeable route of exposure. The plant-incorporated
protectant (PIP) active ingredients are resistance (``R'') proteins
that confer protection against potato pathogens by directly or
indirectly recognizing pathogen-secreted effector proteins. This
recognition leads to the activation of the hypersensitive response,
which is a form of programmed cell death characterized by cytoplasmic
shrinkage, chromatin condensation, mitochondrial swelling,
vacuolization and chloroplast disruption. This hypersensitive response
pathway involves immune signaling triggered by R proteins that is
specific to plants; activated R-proteins cannot trigger cell death in
mammals. Thus, BLB2 and AMR3 proteins do not have a toxic mechanism of
action, but instead activate signaling cascades within the plant which
invoke the plant cell death pathway to prevent growth and spread of the
pathogen.
There is likely to be dietary exposure to BLB2 and AMR3 through
consumption of potato-derived foods containing the proteins. However,
the Agency has concluded that any potential dietary risk from the use
of BLB2 and AMR3 proteins to human health is considered negligible for
the following reasons. (1) As described above, the mode-of-action of
BLB2 and AMR3 is specific to plants and does not affect mammalian
cells. (2) Both the BLB2 and AMR3 proteins are expressed at extremely
low levels in potato, which indicates very low human exposure to the
proteins through the consumption of BLB2- and AMR3-expressing potatoes.
(3) Bioinformatics analyses of BLB2 and AMR3 proteins revealed no
homology with known toxins or allergens. (4) The source organisms for
the active ingredients, Solanum bulbocastanum (BLB2) and Solanum
americanum (AMR3), are not known as allergens. (5) Both proteins have a
history of safe use. BLB2 originates from S. bulbocastanum (ornamental
nightshade), a close potato relative that has 82% sequency similarity
with the tomato gene Mi-1, which has a history of safe use since
tomatoes have been consumed by humans for hundreds of years.
Furthermore, the BLB2 protein is present in two Solanum tuberosum
potato varieties (Toluca and Bionica) that have been conventionally
bred and cultivated for food use in Europe. AMR3 originates from S.
americanum (American black nightshade) which is cultivated for
medicinal and food use, and as part of breeding programs for improved
nutrition. Although some members of the Solanum genus have toxicity,
these effects are caused by glycoalkaloids, which can cause toxicity
even in the common potato, Solanum
[[Page 31651]]
tuberosum. Neither BLB2 nor AMR3 are glycoalkaloids; instead, they
belong to a large family of R-proteins found throughout the plant
kingdom. There are hundreds to thousands of R-proteins in S. tuberosum
and other crops which have a long history of safe consumption.
Oral exposure from ingestion of drinking water is unlikely because
BLB2 and AMR3 proteins are present at very low levels within the plant
cells. If AMR3 and BLB2 do enter the water column, they are expected to
degrade rapidly in the presence of soil microbes, or upon normal
communal water-treatment procedures. In addition, there is unlikely to
be residential or non-occupational exposure given that the active
ingredients are plant-incorporated protectants in potato. Therefore,
the only possible route of non-occupational exposure, other than
dietary, is via handling of the plants and plant products. However,
BLB2 and AMR3 proteins are present in the transformed potato tissues at
levels below the level of detection, resulting in minimal to negligible
exposure. Furthermore, there are no risks associated with these
exposure routes because bioinformatics analysis and the history of safe
use have shown that the proteins are not toxic or allergenic.
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 and allergenicity for these PIP active
ingredients. 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 the BLB2
and AMR3 proteins in potatoes. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion based on the
mode-of-action, history of safe use, and lack of toxicity and
allergenicity for the BLB2 and AMR3 proteins in potato.
B. Analytical Enforcement Methodology
EPA has determined that an analytical method is not required for
enforcement purposes since the Agency is establishing a temporary
exemption from the requirement of a tolerance without any numerical
limitation. Nonetheless, the petitioner submitted a reverse
transcription-quantitative polymerase chain reaction (RT-qPCR) method
for detection of BLB2 and AMR3 in transformed leaves and tubers.
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 BLB2 and ARM3 proteins in potatoes. Therefore,
the expiration date for the temporary exemption from the requirement of
a tolerance for residues of BLB2 and AMR3 proteins in potato, when used
as a plant-incorporated protectant in accordance with the terms of
Experimental Use Permit No. 8971-EUP-3, is extended from March 31,
2024, to March 31, 2025.
IV. Statutory and Executive Order Reviews
This action modifies an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to EPA. 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 action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 18, 2024.
Madison Le,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
[[Page 31652]]
0
2. Revise and republish Sec. 174.545 to subpart W to read as follows:
Sec. 174.545 BLB2 and AMR3 proteins in potato; temporary exemption
from the requirement of a tolerance.
Residues of BLB2 and AMR3 proteins in potato are temporarily exempt
from the requirement of a tolerance when used as a plant-incorporated
protectant in potato in accordance with the terms of Experimental Use
Permit No. 8917-EUP-3. This temporary exemption from the requirement of
a tolerance expires on March 31, 2025.
[FR Doc. 2024-08801 Filed 4-24-24; 8:45 am]
BILLING CODE 6560-50-P