[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58167-58168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26584]


 ========================================================================
 Notices
                                                 Federal Register
 ________________________________________________________________________
 
 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.
 
 ========================================================================
 

  Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / 
Notices  

[[Page 58167]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0096]


Nuseed Americas Inc.; Availability of Petition for Determination 
of Nonregulated Status of Canola Genetically Engineered for Altered Oil 
Profile

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Nuseed Americas Inc. 
(Nuseed) seeking a determination of nonregulated status of canola 
designated as event B0050-027, which has been genetically engineered to 
accumulate the long chain omega-3 fatty acid known as docosahexaenoic 
acid in seed. The petition has been submitted in accordance with our 
regulations concerning the introduction of certain genetically 
engineered organisms and products. We are making the Nuseed petition 
available for review and comment to help us identify potential 
environmental and interrelated economic issues and impacts that the 
Animal and Plant Health Inspection Service may determine should be 
considered in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
February 9, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0096.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0096, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail Detail;D=APHIS-2017-
0096 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.
    The petition is also available on the APHIS Web site at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 17-236-01p.

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 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 (7 U.S.C. 7701 et seq.), 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 (GE) 
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. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received a petition (APHIS Petition Number 17-236-01p) 
from Nuseed Americas Inc. (Nuseed), seeking a determination of 
nonregulated status of canola (Brassica spp.) designated as event 
B0050-027, which has been genetically engineered to accumulate the long 
chain omega-3 fatty acid known as docosahexaenoic acid (DHA) in seed. 
The Nuseed petition states that information collected during field 
trials and laboratory analyses indicates that B0050-027 canola is not 
likely to be a plant pest and therefore should not be a regulated 
article under APHIS' regulations in 7 CFR part 340.
    As described in the petition, B0050-027 canola was developed 
through Agrobacterium tumefaciens-mediated transformation of canola 
cultivar AV Jade with binary vector pJP3416_GA7-ModB. Characterization 
of the DHA canola event revealed two DNA inserts which matched the 
reference of the vector. The expressed DHA pathway enzymes are very low 
in concentration and are only expressed in the seed, and the agronomic 
properties of the event are no different than AV Jade. B0050-027 canola 
is currently regulated under 7 CFR part 340. Interstate movements and 
field tests of B0050-027 canola have been conducted under notifications 
acknowledged by APHIS.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the likelihood of persistence in the environment after completion of 
the tests. Data are gathered on multiple parameters and used by the 
applicant to evaluate agronomic characteristics and product 
performance. These and other data are used by APHIS to determine if the 
new variety poses a plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS

[[Page 58168]]

would accept written comments regarding a petition once APHIS deemed it 
complete.
---------------------------------------------------------------------------

    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------

    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review and comment, and copies are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested 
in receiving comments regarding potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition. We are 
particularly interested in receiving comments regarding biological, 
cultural, or ecological issues, and we encourage the submission of 
scientific data, studies, or research to support your comments.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. Any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decision-making documents. As 
part of our decision-making process regarding a GE organism's 
regulatory status, APHIS prepares a plant pest risk assessment to 
assess its plant pest risk and the appropriate environmental 
documentation--either an environmental assessment (EA) or an 
environmental impact statement (EIS)--in accordance with the National 
Environmental Policy Act (NEPA), to provide the Agency with a review 
and analysis of any potential environmental impacts associated with the 
petition request. For petitions for which APHIS prepares an EA, APHIS 
will follow our published process for soliciting public comment (see 
footnote 1) and publish a separate notice in the Federal Register 
announcing the availability of APHIS' EA and plant pest risk 
assessment.
    Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

    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 5th day of December 2017.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-26584 Filed 12-8-17; 8:45 am]
 BILLING CODE 3410-34-P