[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 [www.gpo.gov]
[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 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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: 
[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 Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174?toc=1.

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), https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. 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 https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    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:
     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 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

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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 https://www.regulations.gov. 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

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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


