[Federal Register Volume 80, Number 86 (Tuesday, May 5, 2015)]
[Notices]
[Pages 25660-25661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10450]


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 Notices
                                                 Federal Register
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 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. 80, No. 86 / Tuesday, May 5, 2015 / Notices  

[[Page 25660]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0076]


J.R. Simplot Co.; Availability of Preliminary Plant Pest Risk 
Assessment and Draft Environmental Assessment for Potato Genetically 
Engineered for Late Blight Resistance, Low Acrylamide Potential, 
Reduced Black Spot Bruising, and Lowered Reducing Sugars

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 preliminary 
plant pest risk assessment and draft environmental assessment for 
Innate\TM\ Potato designated as Russet Burbank event W8, which has been 
genetically engineered for late blight resistance, low acrylamide 
potential, reduced black spot bruising, and lowered reducing sugars.

DATES: We will consider all comments that we receive on or before June 
4, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0076, 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 other information we 
receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076 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 Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 14-093-01p.

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 
14-093-01p) from the J.R. Simplot Company (Simplot) of Boise, ID, 
seeking a determination of nonregulated status of potatoes (Solanum 
tuberosum) designated as Innate\TM\ W8, which have been genetically 
engineered to express reduced acrylamide potential, low black spot 
bruise, late blight resistance, and lowered reducing sugars. Acrylamide 
is a human neurotoxicant and potential carcinogen that may form in 
potatoes and other starchy foods under certain cooking conditions. The 
petition states that these potatoes are unlikely to pose a plant pest 
risk 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 November 10, 2014 (79 FR 66689-66690, Docket No. APHIS-
2014-0076), APHIS announced the availability of the Simplot petition 
for public comment. APHIS solicited comments on the petition for 60 
days ending on January 9, 2015, 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 130 comments on the petition; one of these comments 
included electronic attachments consisting of a consolidated document 
of many identical or nearly identical letters, for a total of 22,673 
comments. Issues raised during the comment period include the 
contamination of conventional potato production, the potential for 
disruption of trade due to the presence of unwanted genetically 
engineered commodities in exports, the need for more research prior to 
approval of the petition, the potential for negative impacts to plant 
fitness and the environment, and health concerns. APHIS has evaluated 
the issues raised during the comment period and, where appropriate, has 
provided a discussion of these issues in our 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-
2014-0076.
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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

[[Page 25661]]

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 EA, preliminary finding of no significant 
impact (FONSI), and its 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 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 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 PPRA and has concluded that Innate\TM\ Potato 
designated as Russet Burbank event W8, which has been genetically 
engineered for late blight resistance, low acrylamide potential, 
reduced black spot bruising, and lowered reducing sugars, 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 Simplot, 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 Innate\TM\ Potato designated as Russet 
Burbank event W8, or (2) make a determination of nonregulated status of 
Innate\TM\ Potato designated as Russet Burbank event W8.
    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).
    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 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 PPRA, as well as the 
previously published petition, are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. After reviewing and evaluating the comments on the draft 
EA and the 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 29th day of April 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-10450 Filed 5-4-15; 8:45 am]
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