83 FR 29742 - Nuseed Americas Inc.; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Canola Genetically Engineered for Altered Oil Profile

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 123 (June 26, 2018)

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 B0050-027, which has been genetically engineered to accumulate the long chain omega-3 fatty acid known as docosahexaenoic acid in seed. We are making the draft PPRA and draft EA available for public review and comment.

[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29742-29743]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13589]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0096]


Nuseed Americas Inc.; Availability of a Draft Plant Pest Risk 
Assessment and Draft Environmental Assessment for 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 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 B0050-027, which has been genetically 
engineered to accumulate the long chain omega-3 fatty acid known as 
docosahexaenoic acid in seed. 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 July 
26, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0096.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0096, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents for this petition and any comments we receive 
on this docket may be viewed 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 for this petition are also available on the 
APHIS website at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 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 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 
17-236-01p) 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.

[[Page 29743]]

    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. 
APHIS received four comments on the petition. Two of the comments were 
from individuals and two were from the canola industry. 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-
2017-0096.
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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.
    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 canola 
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, 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 Nuseed, 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 B0050-027, 
or (2) make a determination of nonregulated status of canola designated 
as event B0050-027.
    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 20th day of June 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-13589 Filed 6-25-18; 8:45 am]
 BILLING CODE 3410-34-P