[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38588-38589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16921]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2018-0014]
BASF Plant Science, LP; 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.
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SUMMARY: We are advising the public of our determination that canola
designated as event LBFLFK, which has been genetically engineered 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, 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 Science, 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: This change in regulatory status will be recognized August 7,
2019.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received 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.
Supporting documents are 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, Director,
Biotechnology Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236;
(301) 851-3901; 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
17-321-01p) 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
[[Page 38589]]
(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.
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\1\ On March 6, 2012, we published in the Federal Register (77
FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our
process for soliciting public comments and information when
considering petitions for determinations of nonregulated status for
GE organisms (see 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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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 evaluated the issues raised during the comment period
and, where appropriate, provided a discussion of those issues in our
draft environmental assessment (EA).
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 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 (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 draft PPRA from April
4, 2019, to May 6, 2019.\3\ APHIS solicited comments on those documents
and whether the subject canola is likely to pose a plant pest risk.
APHIS received three comments on the petition and supporting documents,
one of which opposed and two of which supported a decision of
nonregulated status for LBFLFK canola. Those comments are addressed in
our final EA.
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\3\ 84 FR 13243-13244.
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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 LBFLFK canola. 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 LBFLFK canola).
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 LBFLFK canola 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 1st day of August 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-16921 Filed 8-6-19; 8:45 am]
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