[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Notices]
[Pages 17625-17626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07359]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0015]


Bayer CropScience LP.; Availability of Draft Environmental 
Assessment, Plant Pest Risk Similarity Assessment, Preliminary Finding 
of No Significant Impact, and Preliminary Decision for an Extension of 
a Determination of Nonregulated Status of Canola Genetically Engineered 
for Male Sterility and Glufosinate-Ammonium Resistance

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 has reached a preliminary decision to extend our 
determination of nonregulated status of InVigor[supreg] MS8 canola 
(hereinafter MS8 canola) to Bayer's canola event MS11 in response to a 
request from Bayer CropScience LP. MS11 canola has been genetically 
engineered for male sterility and resistance to the herbicide 
glufosinate-ammonium using the same mechanism of action as MS8 canola. 
We are making available for public comment our draft environmental 
assessment, preliminary regulatory determination, preliminary finding 
of no significant impact, and plant pest risk similarity assessment for 
the proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before May 
12, 2017.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0015.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0015, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The Bayer CropScience LP. extension request, our draft 
environmental assessment, plant pest risk similarity assessment, our 
preliminary finding of no significant impact, our preliminary 
determination, and any comments we receive on this docket may be viewed 
at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0015 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.
    Supporting documents and any comments we received regarding our 
determination of nonregulated status of the antecedent organism, MS8 
canola, may be inspected in our reading room. Supporting documents may 
also be found on the APHIS Web site for MS11 canola (the organism under 
evaluation) under APHIS Petition Number 16-235-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Document Control 
Officer/Team Leader, Policy Coordination Programs, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 
20737-1236; (301) 851-3954, email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (PPA) (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 organisms (GE) 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. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    On March 31, 1999,\1\ APHIS announced its determination of 
nonregulated status of MS8 canola (Brassica napus L.), which was 
genetically engineered for male sterility and resistance to the 
herbicide glufosinate-ammonium. APHIS has received a request for an 
extension of that determination of nonregulated status of MS8 canola to 
canola designated as canola event MS11 (APHIS Petition Number 16-235-
01p) from Bayer CropScience LP. (Bayer) of Research Triangle Park, NC. 
MS11 canola expresses male sterility and resistance to the herbicide 
glufosinate-ammonium. In its request, Bayer stated that this canola is 
similar to the antecedent organism MS8 canola and, based on the 
similarity to the antecedent organism, is unlikely to pose a plant pest 
risk and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
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    \1\ https://www.federalregister.gov/documents/1999/03/31/99-7803/agrevo-usa-co-availability-of-determination-of-nonregulated-status-for-canola-genetically-engineered?utm_content=next&utm_medium=PrevNext&utm_source=Article.
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    As described in the extension request, MS11 canola was developed 
using the gene cassette pTCO113 containing the same genetic events used 
to transform MS8 canola (gene cassette pTHW107) with male sterility and 
resistance to glufosinate-ammonium. Based on the information in the 
request, we have concluded that MS11 canola is similar to MS8 canola. 
MS11 canola is currently regulated under 7 CFR part 340.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS evaluates the plant pest risk of the article. 
In section 403 of the PPA, ``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

[[Page 17626]]

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 prepared a plant pest risk similarity assessment (PPRSA) 
to compare MS11 canola to the antecedent. As described in the PPRSA, 
the proteins expressed in MS11 canola are similar to those expressed in 
MS8 canola, and APHIS has concluded that the proteins expressed in MS8 
canola are unlikely to pose a plant health risk. Therefore, based on 
the similarity between MS8 canola and MS11 canola as described in the 
PPRSA, APHIS has concluded that MS11 canola is no more likely to pose a 
plant pest risk than MS8 canola.
    APHIS has also prepared a draft environmental assessment (EA) in 
which it presents two alternatives based on its analysis of data 
submitted by Bayer, a review of other scientific data, and field tests 
conducted under APHIS oversight. APHIS is considering the following 
alternatives: (1) Take no action, i.e., APHIS would not change the 
regulatory status of MS11 canola and it would continue to be a 
regulated article, or (2) make a determination of nonregulated status 
for MS11 canola.
    Based on the similarity of MS11 canola to MS8 canola, APHIS has 
also prepared a preliminary finding of no significant impact (FONSI) 
for MS11 canola. The draft EA and the FONSI were prepared in accordance 
with: (1) The National Environmental Policy Act of 1969 (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).
    APHIS has analyzed information submitted by Bayer, references 
provided in the extension request, peer-reviewed publications, and 
supporting documentation prepared for the antecedent organism. Based on 
APHIS' analysis of this information and the similarity of MS11 canola 
to the antecedent organism MS8 canola, APHIS has determined that MS11 
canola is unlikely to pose a plant pest risk. We have therefore reached 
a preliminary decision to approve the request to extend the 
determination of nonregulated status of MS8 canola to MS11 canola, 
whereby MS11 canola would no longer be subject to our regulations 
governing the introduction of certain genetically engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of MS8 canola to MS11 canola.
    APHIS will accept written comments on the draft EA and preliminary 
FONSI regarding a determination of nonregulated status of MS11 canola 
for a period of 30 days from the date this notice is published in the 
Federal Register. The draft EA and preliminary FONSI, as well as the 
extension request, PPRSA, and our preliminary determination for MS11 
canola, are available for public review as indicated under ADDRESSES 
and FOR FURTHER INFORMATION CONTACT above. Copies of these documents 
may also be obtained by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating the comments, APHIS will furnish a response to 
the petitioner regarding our final regulatory determination. APHIS will 
also publish a notice in the Federal Register announcing the regulatory 
status of MS11 canola and the availability of APHIS' written 
environmental decision and 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 6th day of April 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-07359 Filed 4-11-17; 8:45 am]
 BILLING CODE 3410-34-P