Rule2024-08801
BLB2 and AMR3 Proteins in Potato; Temporary Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 25, 2024
Effective
April 25, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 81 (Thursday, April 25, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and for the OPP Docket is (202) 566-1744. Please review
the visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#094b59594d4f5b47667d606a6c7a496c7968276e667f"><span class="__cf_email__" data-cfemail="8eccdedecac8dcc0e1fae7edebfdceebfeefa0e9e1f8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 174 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>. Additional instructions on commenting or visiting the docket,
along with more information about dockets generally, is available at
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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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 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.
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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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.