[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14440-14441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05444]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
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  Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / 
Notices  

[[Page 14440]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0023]


BASF Corporation; Determination of Nonregulated Status of Plant-
Parasitic, Nematode-Protected and Herbicide-Tolerant Soybean

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that soybean 
designated as event GMB151, which has been developed using genetic 
engineering for resistance to the plant-parasitic nematode, soybean 
cyst nematode (Heterodera glycines), and for tolerance to 4-
hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor herbicides, is no 
longer considered regulated. Our determination is based on our 
evaluation of data submitted by BASF Corporation in its petition for a 
determination of nonregulated status, our analysis of available 
scientific data, and public comments received in response to our 
previous notices announcing the availability of the petition for 
nonregulated status and its associated draft environmental assessment 
and draft plant pest risk assessment. This notice also announces the 
availability of our final environmental assessment, final plant pest 
risk assessment, written determination, and finding of no significant 
impact.

DATES: This change in regulatory status was recognized on March 9, 
2022.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at www.regulations.gov and entering APHIS-2020-
0023 in the Search field. You can also view them in our reading room, 
which is located in Room 1620 of the USDA South Building, 14th Street 
and Independence Avenue SW, Washington, DC. Normal reading room hours 
are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be 
sure someone is there to help you, please call (202) 799-7039 before 
coming.
    Supporting documents are also available on the APHIS website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status under APHIS Petition 
19-317-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1238; (301) 851-3892, email: [email protected]. To obtain 
copies of the supporting documents for this petition, contact Ms. Cindy 
Eck at (301) 851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.), 
the regulations in 7 CFR part 340, ``Movement of Organisms Modified or 
Produced Through Genetic Engineering,'' regulate, among other things, 
the importation, interstate movement, or release into the environment 
of organisms modified or produced through genetic engineering that are 
plant pests or pose a plausible plant pest risk.
    The petition for nonregulated status described in this notice was 
evaluated under the version of the regulations effective at the time 
that it was received. The Animal and Plant Health Inspection Service 
(APHIS) issued a final rule, published in the Federal Register on May 
18, 2020 (85 FR 29790-29838, Docket No. APHIS-2018-0034),\1\ revising 7 
CFR part 340; however, the final rule has been implemented in phases. 
The new Regulatory Status Review (RSR) process, which replaces the 
petition for determination of nonregulated status process, became 
effective on April 5, 2021, for corn, soybean, cotton, potato, tomato, 
and alfalfa. The RSR process is effective for all crops as of October 
1, 2021. However, ``[u]ntil RSR is available for a particular crop . . 
. APHIS will continue to receive petitions for determination of 
nonregulated status for the crop in accordance with the [legacy] 
regulations at 7 CFR 340.6.'' (85 FR 29815). This petition for a 
determination of nonregulated status is being evaluated in accordance 
with the regulations at 7 CFR 340.6 (2020) as it was received by APHIS 
on January 28, 2020.
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    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
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    The petition (APHIS Petition Number 19-317-01p) \2\ from BASF 
Corporation, of Research Triangle Park, NC (BASF), seeks a 
determination of nonregulated status of soybean (Glycine max) 
designated as event GMB151, which has been developed using genetic 
engineering for resistance to the plant-parasitic nematode, soybean 
cyst nematode (Heterodera glycines), and for tolerance to 4-
hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor herbicides. The 
BASF petition states that information collected during field trials and 
laboratory analyses indicates that GMB151 soybean is unlikely to pose a 
plant pest risk, and therefore should not be regulated under APHIS' 
regulations in 7 CFR part 340.
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    \2\ To view the petition, go to https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.
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    According to our process \3\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of 
organisms developed using genetic engineering, APHIS accepts written 
comments regarding a petition once APHIS deems it complete. In a notice 
published in the Federal Register on May 28, 2020 (85 FR 32004-32005, 
Docket No. APHIS-2020-0023),\4\ APHIS announced the availability of the 
BASF petition for public comment. APHIS solicited comments on the 
petition for 60 days ending on July 27, 2020, in order to help identify 
potential environmental and interrelated economic issues and impacts 
that APHIS may determine

[[Page 14441]]

should be considered in our evaluation of the petition.
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    \3\ On March 6, 2012, we published in the Federal Register (77 
FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our 
process for soliciting public comments and information when 
considering petitions for determinations of nonregulated status for 
organisms developed using genetic engineering. To view the notice, 
go to http://www.regulations.gov and enter APHIS-2011-0129 in the 
Search field.
    \4\ To view the notice, petition, supporting documents, and the 
comments that we received, go to www.regulations.gov and enter 
APHIS-2020-0023 in the Search field.
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    APHIS received nine comments on the petition from agricultural 
trade groups, farmers, and members of the public. Five comments 
generally supported BASF's petition, while four expressed objections to 
crops developed or modified through genetic engineering.
    APHIS decided, based on its review of the petition and its 
evaluation and analysis of the comments received during the 60-day 
public comment period on the petition, that the petition involves an 
organism developed using genetic engineering that raises substantive 
new issues. According to our public review process for such petitions 
(see footnote 3), APHIS is following Approach 2, in which we first 
solicit written comments from the public on a draft environmental 
assessment (EA) and a draft plant pest risk assessment (PPRA) for a 30-
day comment period through the publication of a Federal Register 
notice. Then, after reviewing and evaluating the comments on the draft 
EA and the draft PPRA and other information, APHIS revises the draft 
PPRA as necessary and prepares a final EA. APHIS also publishes a 
notice in the Federal Register announcing the regulatory status of the 
organism developed using genetic engineering and the availability of 
APHIS' final EA, PPRA, finding of no significant impact (FONSI), and 
our regulatory determination.
    A second opportunity for public involvement was provided on August 
17, 2021, with a notice published in the Federal Register (86 FR 45955-
45956) announcing the availability of the draft EA and draft PPRA for 
public review and comment. That comment period closed on September 16, 
2021. APHIS received 2,743 comments on the petition and supporting 
documents. All but eight of the comments consisted of identical and 
near-identical copies of a form letter submitted by different 
individuals who expressed their general opposition to the concept and 
use of genetic engineering for any purpose. Commenters objected to 
GMB151 soybean because it expresses a novel protein from Bacillus 
thuringiensis, which many stated has not been adequately evaluated for 
use as a pesticide. Others objected to deregulation of GMB151 soybean 
on grounds that it would contribute to weed resistance. Commenters also 
opposed deregulation because it would contribute to an increase in the 
use of isoxaflutole, which they stated will jeopardize human health and 
safety. The comments are addressed in our final EA.

National Environmental Policy Act

    The final EA contains the results of APHIS' review and evaluation 
of the comments received during the comment period on the draft EA, 
draft PPRA, and the petition. The final EA provides the public with 
documentation of APHIS' review and analysis of any potential 
environmental impacts associated with the determination of nonregulated 
status of GMB151 soybean. The EA was prepared in accordance with: (1) 
National Environmental Policy Act (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372). Based on our EA, 
the response to public comments, and other pertinent scientific data, 
APHIS has reached a FONSI with regard to the preferred alternative 
identified in the EA (to make a determination of nonregulated status of 
GMB151 soybean).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
BASF, references provided in the petition, peer-reviewed publications, 
information analyzed in the EA, the PPRA, comments provided by the 
public, and information provided in APHIS' response to those public 
comments, APHIS has determined that GMB151 soybean is unlikely to pose 
a plant pest risk and therefore is no longer subject to our regulations 
governing the importation, interstate movement, or release into the 
environment of organisms developed using genetic engineering.
    Copies of the signed determination document, PPRA, final EA, and 
FONSI, as well as the previously published petition and supporting 
documents, are available as indicated in the ADDRESSES and FOR FURTHER 
INFORMATION CONTACT sections of this notice.
    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Done in Washington, DC, this 10th day of March 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-05444 Filed 3-14-22; 8:45 am]
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