[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
________________________________________________________________________
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.
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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]
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