[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15095-15096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06016]


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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. 79, No. 52 / Tuesday, March 18, 2014 / 
Notices  

[[Page 15095]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0028]


BASF Plant Sciences, LP; Determination of Nonregulated Status of 
Soybean Genetically Engineered for Resistance to the Herbicide 
Imidazolinone

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a soybean 
event developed by BASF Plant Sciences, LP designated as BPS-CV127-9, 
which has been genetically engineered for resistance to treatment with 
imidazolinone herbicides, is no longer considered a regulated article 
under our regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by BASF Plant Sciences, LP in its petition for a 
determination of nonregulated status, our analysis of available 
scientific data, and comments received from the public in response to 
our previous notices announcing the availability of the petition for 
nonregulated status and its associated environmental assessment and 
plant pest risk assessment. This notice also announces the availability 
of our written determination and finding of no significant impact.

DATES: Effective Date: March 18, 2014.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0028 or in our reading room, which is 
located in Room 1141 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 Web site at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition Number 09-015-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, 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: 

Background

    The regulations in 7 CFR part 340, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason To Believe Are Plant Pests,'' 
regulate, among other things, the introduction (importation, interstate 
movement, or release into the environment) of organisms and products 
altered or produced through genetic engineering that are plant pests or 
that there is reason to believe are plant pests. Such genetically 
engineered organisms and products are considered ``regulated 
articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 
09-015-01p) from BASF Plant Sciences, LP (BASF) of Research Triangle 
Park, NC, seeking a determination of nonregulated status of soybean 
(Glycine max) designated as BPS-CV127-9 (CV127), which has been 
genetically engineered for resistance to the herbicide imidazolinone. 
The petition states that this soybean is unlikely to pose a plant pest 
risk and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
    According to our process \1\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of 
genetically engineered (GE) organisms, APHIS accepts written comments 
regarding a petition once APHIS deems it complete. In a notice \2\ 
published in the Federal Register on July 13, 2012, (77 FR 41363-41364, 
Docket No. APHIS-2012-0028), APHIS announced the availability of the 
BASF petition for public comment. APHIS solicited comments on the 
petition for 60 days ending on September 11, 2012, in order to help 
identify potential environmental and interrelated economic issues and 
impacts that APHIS may determine should be considered in our evaluation 
of the petition.
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    \1\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0028.
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    APHIS received 75 comments on the petition. Several of these 
comments included electronic attachments consisting of a consolidated 
document of many identical or nearly identical letters, for a total of 
4,676 comments. APHIS decided, based on its review of the petition and 
its evaluation and analysis of comments received during the 60-day 
public comment period on the petition, that the petition involves a GE 
organism that raises substantive new issues. According to our public 
review process for such petitions (see footnote 1), APHIS first 
solicits written comments from the public on a draft environmental 
assessment (EA) and 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 
PPRA and other information, APHIS revises the PPRA as necessary and 
prepares a final EA and, based on the final EA, a National 
Environmental Policy Act (NEPA) decision document (either a finding of 
no significant impact (FONSI) or a notice of intent to prepare an 
environmental impact statement). If a FONSI is reached, APHIS furnishes 
a

[[Page 15096]]

response to the petitioner, either approving or denying the petition. 
APHIS also publishes a notice in the Federal Register announcing the 
regulatory status of the GE organism and the availability of APHIS' 
final EA, PPRA, FONSI, and our regulatory determination.
    In a notice (see footnote 2) published in the Federal Register on 
November 7, 2013, (78 FR 66892-66893, Docket No. APHIS-2012-0028), 
APHIS announced the availability of a PPRA and a draft EA for public 
comment. APHIS solicited comments on the draft EA, the PPRA, and 
whether the subject soybeans are likely to pose a plant pest risk for 
30 days ending on December 9, 2013. APHIS received 10 comments during 
the comment period. All comments submitted to the docket were carefully 
analyzed by APHIS. A number of these comments were generally opposed to 
GE organisms or the use of herbicide-resistant crops. Others had 
concerns about potential impacts associated with the herbicides used on 
GE crops. In general, commenters expressed their opposition to our 
determination of nonregulatory status but did not identify elements in 
the PPRA or EA that they perceived to be inadequate or provide any 
specific supporting evidence for their opposition. APHIS has addressed 
the issues raised during the comment period and has provided responses 
to these comments as an attachment to the FONSI.

National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and PPRA and other information, APHIS 
has prepared a final EA. The EA has been prepared to provide the public 
with documentation of APHIS' review and analysis of any potential 
environmental impacts associated with the determination of nonregulated 
status of BASF's CV127 soybean. The EA was prepared in accordance with: 
(1) 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 BASF's CV127 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 BASF's CV127 soybean is unlikely to 
pose a plant pest risk and therefore is no longer subject to our 
regulations governing the introduction of certain GE organisms.
    Copies of the signed determination document, PPRA, final EA, FONSI, 
and response to comments, 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 12th day of March 2014.
 Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-06016 Filed 3-17-14; 8:45 am]
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