[Federal Register Volume 88, Number 49 (Tuesday, March 14, 2023)]
[Rules and Regulations]
[Pages 15613-15616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05246]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2020-0234; FRL-10776-01-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 establishes 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

[[Page 15614]]

(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, 2024.

DATES: This regulation is effective March 14, 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-2020-0234, 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. Please review the 
visitor instructions and additional information about the docket 
available at 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-2020-0234 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).
    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-2020-0234, 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 document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 0G8830) by J.R. Simplot Company, 5369 W Irving Street, 
Boise, ID 83706. The petitioner requested that 40 CFR part 174 be 
amended by establishing a temporary exemption from the requirement of a 
tolerance for residues of the plant-incorporated protectants BLB2 and 
AMR3 proteins in potato. 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

[[Page 15615]]

consider ``available information concerning the cumulative effects of 
[a particular pesticide's] . . . residues and other substances that 
have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data 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, 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 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, 
an exemption from the requirement of a tolerance is established for 
residues of BLB2 and AMR3 proteins in potato when used in accordance 
with label directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes 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

[[Page 15616]]

not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). 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: March 6, 2023.
Charles Smith,
Director, Biopesticides and Pollution Prevention Division.

    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.  174.545 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, 2024.

[FR Doc. 2023-05246 Filed 3-13-23; 8:45 am]
BILLING CODE 6560-50-P


