Rule2023-04979
Modified Potato Acetolactate Synthase (StmALS) in Potato; 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
March 15, 2023
Effective
March 15, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of modified potato acetolactate synthase (StmALS) in potato when used in accordance with label directions and good agricultural practices. J.R. Simplot Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of StmALS under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 88 Issue 50 (Wednesday, March 15, 2023)</title>
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[Federal Register Volume 88, Number 50 (Wednesday, March 15, 2023)]
[Rules and Regulations]
[Pages 15915-15918]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04979]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2020-0237; 10775-01-OCSPP]
Modified Potato Acetolactate Synthase (StmALS) in Potato;
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
[[Page 15916]]
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of modified potato acetolactate synthase
(StmALS) in potato when used in accordance with label directions and
good agricultural practices. J.R. Simplot Company submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of StmALS under FFDCA when used in accordance with this
exemption.
DATES: This regulation is effective March 15, 2023. Objections and
requests for hearings must be received on or before May 15, 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-2020-0237, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, 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#a6e4f6f6e2e0f4e8c9d2cfc5c3d5e6c3d6c788c1c9d0"><span class="__cf_email__" data-cfemail="0c4e5c5c484a5e426378656f697f4c697c6d226b637a">[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 Government Publishing Office's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174?toc=1">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174?toc=1</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-2020-0237 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
May 15, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>. At this
time, because of the COVID-19 pandemic, the judges and staff of the
Office of Administrative Law Judges are working remotely and not able
to accept filings or correspondence by courier, personal delivery, or
commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at (202) 564-6281. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
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-2020-0237, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically 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 June 24, 2020 (85 FR 37806) (FRL-10010-
82) EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance exemption
petition (PP IN-11411) by J.R. Simplot Company, 5369 W Irving Street,
Boise, ID 83706. The petition requested that 40 CFR part 174 be amended
by establishing an exemption from the requirement of a
[[Page 15917]]
tolerance for residues of StmALS in potato. That notice 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>. EPA received no comments in response to the notice
of filing.
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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 toxicological and exposure data on
StmALS and considered their validity, completeness, and reliability, as
well as the relationship of this information to human risk. A full
summary of the data upon which EPA relied and its risk assessment based
on those 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, as well as other
relevant information, is available in the docket for this action, EPA-
HQ-OPP-2020-0237, as described under ADDRESSES.
Available data have demonstrated that, with regard to humans,
StmALS is not anticipated to be toxic or allergenic via any reasonably
foreseeable route of exposure. StmALS (modified potato acetolactate
synthase), is a plant-incorporated protectant (PIP) inert ingredient
produced within the plant to be a selective marker for PIP
transformation events. StmALS is a protein derived from the native
acetolactate synthase (ALS) protein found in potato (Solanum tuberosum)
and has been modified from the naturally occurring form by two amino
acid substitutions. StmALS does not have any pesticidal activity of its
own; rather, the modified protein confers tolerance to sulfonylureas
and imidazolinone herbicides by interfering with their binding to
native ALS protein within the plant. Thus, the herbicide tolerance
serves as a positive selectable marker allowing for the identification
of transformed PIP plants.
There is likely to be dietary exposure to StmALS through
consumption of potato-derived foods containing this protein. However,
the Agency has concluded that any potential dietary risk from the use
of StmALS protein to human health is considered negligible for the
following reasons. (1) As described above, the mode-of-action of StmALS
protein is tolerance to sulfonylureas and imidazolinone herbicides; the
protein is otherwise not pesticidal or toxic. (2) Bioinformatics
analyses showed that there is no significant homology between StmALS
and known toxins or allergens. (3) Data were submitted to demonstrate
that the StmALS protein is denatured and becomes insoluble after heat
treatment. Since potatoes are cooked by frying, boiling, or baking at
high temperatures, and not consumed raw, StmALS is expected to become
denatured during potato processing. (4) Additionally submitted data
support the lack of allergenic potential for StmALS. The protein is not
glycosylated and is rapidly and completely digested by stomach and
pancreatic proteases, indicating that StmALS is not sufficiently stable
or persistent enough to interact with the immune system and induce
allergy. (5) ALS protein, from which StmALS is derived, has a history
of safe use through the consumption of potatoes. The StmALS protein is
99.7% similar to the native ALS found in potato, differing by only two
amino acids. These modifications do not affect the mode of action of
StmALS and do not result in the production of a toxic protein. Since
potatoes are a staple of the human diet, people have long been exposed
to ALS without documented adverse effects.
Oral exposure from ingestion of drinking water is unlikely because
StmALS is present at low levels and is confined within the plant cells.
If StmALS does enter the water column, it is 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 inert
ingredient is confined within the potato plant. Therefore, the only
possible route of non-occupational exposure, other than dietary, is via
handling of the plants and plant products. However, there are no risks
associated with these exposure routes because, based on bioinformatics
analysis and the history of safe use of the highly similar ALS protein,
the StmALS protein is 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 StmALS. As a result,
an additional margin of safety for the protection of infants and
children is unnecessary.
Based upon its evaluation described above and 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 StmALS protein 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 of the highly similar ALS protein, and lack of toxicity and
allergenicity for StmALS protein.
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 has submitted an immunoblot
assay for detection of StmALS with an antibody that is specific to the
protein but does not show cross reactivity with native
[[Page 15918]]
potato ALS protein. The assay adequately detects StmALS in potato leaf
and tuber tissues.
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 StmALS protein in potatoes. Therefore, an
exemption from the requirement of a tolerance is established for
residues of StmALS protein in potato when used in accordance with label
directions and good agricultural practices.
IV. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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, 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 (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 (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 (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: March 7, 2023.
Edward Messina,
Director, 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.
0
2. Add Sec. 174.544 to subpart W to read as follows:
Sec. 174.544 Modified Potato Acetolactate Synthase (StmALS) in
potato; exemption from the requirement of a tolerance.
Residues of modified potato acetolactate synthase (StmALS) in
potato are exempt from the requirement of a tolerance when used as a
plant-incorporated protectant inert ingredient.
[FR Doc. 2023-04979 Filed 3-14-23; 8:45 am]
BILLING CODE 6560-50-P
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