83 FR 43634 - Nuseed Americas Inc.; Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 166 (August 27, 2018)

We are advising the public of our determination that 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, 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 Nuseed Americas Inc. 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.

[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Pages 43634-43635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18565]


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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 
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Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / 
Notices

[[Page 43634]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0096]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that 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, 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 Nuseed Americas Inc. 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: This change in regulatory status will be recognized August 27, 
2018.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;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.
    Supporting documents are also available on the APHIS website 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 supporting documents for this petition, contact Ms. Cindy Eck at 
(301) 851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION: 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 
17-236-01p) from Nuseed Americas Inc. (Nuseed) of Breckenridge, MN, 
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.
    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 December 11, 2017 (82 FR 58167-58168, Docket No. APHIS-
2017-0096), APHIS announced the availability of the Nuseed petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on February 9, 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.
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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-
2017-0096.
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    APHIS received four comments on the petition. Issues raised during 
the comment period included concerns regarding product stewardship 
during production and marketing. These concerns were addressed by 
Nuseed with supplemental product stewardship data provided to APHIS in 
support of the petition.
    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 a GE 
organism that raises substantive new issues. According to our public 
review process for such petitions (see footnote 1), APHIS is following 
Approach 2, where 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 and, 
based on the final EA, a National Environmental Policy Act (NEPA) 
finding document

[[Page 43635]]

(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 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.
    APHIS sought public comment on a draft EA and a draft PPRA from 
June 26, 2018, to July 26, 2018.\3\ APHIS solicited comments on the 
draft EA, the draft PPRA, and whether the subject canola is likely to 
pose a plant pest risk. APHIS received two comments on the petition, 
both of which supported a decision of nonregulated status for event 
B0050-027 canola.
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    \3\ 83 FR 29742-29743.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and draft 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 canola designated as event B0050-027. 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 
canola designated as event B0050-027).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Nuseed, 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 canola designated as 
event B0050-027 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 22nd day of August 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-18565 Filed 8-24-18; 8:45 am]
 BILLING CODE 3410-34-P