[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13722-13723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06399]



[[Page 13722]]

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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0014]


BASF Plant Science, LP; Availability of Petition for 
Determination of Nonregulated Status of Canola Genetically Engineered 
for Altered Oil Profile and Resistance to an Imidazolinone Herbicide

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 BASF Plant Science, LP, 
seeking a determination of nonregulated status of canola designated as 
event LBFLFK, which has been genetically engineered (GE) to allow for 
the synthesis of long chain omega-3 polyunsaturated fatty acids, 
including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), 
from oleic acid in canola seed. The GE canola has also been genetically 
engineered for resistance to an imidazolinone herbicide. The petition 
has been submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms. We are making 
the BASF Plant Science, LP 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 May 
29, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0014.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0014, 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;D=APHIS-2018-
0014 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 website at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 17-321-01p.

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,'' the Animal and 
Plant Health Inspection Service (APHIS) regulates, among other things, 
the introduction (importation, interstate movement, or release into the 
environment) of organisms 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 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 17-321-01p) 
from BASF Plant Science, LP, of Florham Park, NJ (BASF), seeking a 
determination of nonregulated status of canola (Brassica napus L.) 
designated as event LBFLFK, which has been genetically engineered to 
allow for the synthesis of long chain omega-3 polyunsaturated fatty 
acids (LC-PUFAs), including eicosapentaenoic acid (EPA) and 
docosahexaenoic acid (DHA), from oleic acid in canola seed. The GE 
canola has also been genetically engineered for resistance to an 
imidazolinone herbicide. The BASF petition states that information 
collected during field trials and laboratory analyses indicates that 
LBFLFK 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, LBFLFK canola was developed through 
Agrobacterium rhizogenes-mediated transformation of canola variety 
Kumily using a single transformation vector to introduce fatty acid 
synthesis genes (desaturases and elongases) and an herbicide resistance 
gene. Characterization of the LBFLFK canola event demonstrated that 
there are no safety concerns according to the applicant. LBFLFK canola 
is currently regulated under 7 CFR part 340. Interstate movements and 
field tests of LBFLFK canola have been conducted under APHIS 
authorizations.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk of dissemination and persistence in the environment after 
completion of the tests. Data were gathered on multiple parameters and 
used by the applicant to evaluate agronomic characteristics and product 
performance. These and other data will be 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 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

[[Page 13723]]

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, on March 26, 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-06399 Filed 3-29-18; 8:45 am]
 BILLING CODE 3410-34-P