[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13243-13244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06630]


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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 
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  Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / 
Notices  

[[Page 13243]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0014]


BASF Plant Science, LP; Availability of a Draft Plant Pest Risk 
Assessment and Draft Environmental Assessment for Canola Genetically 
Engineered for Altered Oil Profile and Resistance to an Imidazolinone 
Herbicide

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is making available for public comment a draft plant 
pest risk assessment (PPRA) and draft environmental assessment (EA) for 
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 and 
docosahexaenoic acid, from oleic acid in canola seed. The GE canola has 
also been genetically engineered for resistance to an imidazolinone 
herbicide. We are making the draft PPRA and draft EA available for 
public review and comment.

DATES: We will consider all comments that we receive on or before May 
6, 2019.

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) 7997039 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. Subray Hegde, Acting Program 
Director, Biotechnology Risk Analysis Programs, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; 301-831-3901; 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. APHIS 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 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.
    According to our process \1\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in the Federal 
Register on March 30, 2018 (83 FR 13722-13723, Docket No. APHIS-2018-
0014), APHIS announced the availability of the BASF petition for public 
comment. APHIS solicited comments on the petition for 60 days ending on 
May 29, 2018, 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. APHIS received 
eight comments on the petition. Three of the comments were from 
individuals, three were from the canola industry, one was from a public 
interest group, and one was from a State government. APHIS has 
evaluated the issues raised during the comment period and, where 
appropriate, has provided a discussion of these issues in our draft 
environmental assessment (EA).
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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, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2018-0014.
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    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), the second opportunity for 
public involvement follows one of two approaches, as described below.

[[Page 13244]]

    If APHIS decides, 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 no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its draft EA, preliminary finding of no 
significant impact (FONSI), and its draft plant pest risk assessment 
(PPRA) for a 30-day public review period. APHIS will evaluate any 
information received related to the petition and its supporting 
documents during the 30-day public review period.
    If APHIS decides, 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, APHIS will follow Approach 
2. Under Approach 2, APHIS first solicits written comments from the 
public on a draft EA and draft 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 draft PPRA and other 
information, APHIS will revise the PPRA as necessary and prepare a 
final EA and, based on the final EA, a National Environmental Policy 
Act (NEPA) decision document (either a FONSI or a notice of intent to 
prepare an environmental impact statement). For this petition, we are 
using Approach 2.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA, to provide the Agency and the public with a 
review and analysis of any potential environmental impacts that may 
result if the petition request is approved.
    APHIS has prepared a draft PPRA and has concluded that BASF canola 
designated as event LBFLFK, which has been genetically engineered to 
allow for the synthesis of long chain omega-3 polyunsaturated fatty 
acids, including EPA and DHA, from oleic acid in canola seed, and for 
resistance to an imidazolinone herbicide, is unlikely to pose a plant 
pest risk. In section 403 of the Plant Protection Act, ``plant pest'' 
is defined as any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: A protozoan, a nonhuman animal, a parasitic 
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or 
other pathogen, or any article similar to or allied with any of the 
foregoing.
    APHIS has also prepared a draft EA in which we present two 
alternatives based on our analysis of data submitted by BASF, a review 
of other scientific data, field tests conducted under APHIS oversight, 
and comments received on the petition. APHIS is considering the 
following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of canola designated as event LBFLFK, or 
(2) make a determination of nonregulated status of canola designated as 
event LBFLFK.
    The draft 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) U.S. Department of Agriculture 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372).
    In accordance with 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 on our draft EA and our draft PPRA 
regarding the petition for a determination of nonregulated status from 
interested or affected persons for a period of 30 days from the date of 
this notice. Copies of the draft EA and the draft PPRA, as well as the 
previously published petition, are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the 30-day comment period closes, APHIS will review and 
evaluate any information received during the comment period and any 
other relevant information. After reviewing and evaluating the comments 
on the draft EA and the draft PPRA and other information, APHIS will 
revise the PPRA as necessary and prepare a final EA. Based on the final 
EA, APHIS will prepare a NEPA decision document (either a FONSI or a 
notice of intent to prepare an environmental impact statement). If a 
FONSI is reached, APHIS will furnish a response to the petitioner, 
either approving or denying the petition. APHIS will also publish 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.

    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 1st day of April 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-06630 Filed 4-3-19; 8:45 am]
 BILLING CODE 3410-34-P