[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31080-31082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12555]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0067]


J.R. Simplot Co.; Availability of Plant Pest Risk Assessment and 
Environmental Assessment for Determination of Nonregulated Status of 
Potato Genetically Engineered for Low Acrylamide Potential and Reduced 
Black Spot Bruise

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 our plant 
pest risk assessment and our draft environmental assessment regarding a 
request from the J.R. Simplot Company seeking a determination of 
nonregulated status of potatoes designated as InnateTM 
potatoes (events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50), 
which have been genetically engineered for low acrylamide potential 
(acrylamide is a human neurotoxicant and potential carcinogen that may 
form in potatoes and other starchy foods under certain cooking 
conditions) and reduced black spot bruise. We are soliciting comments

[[Page 31081]]

on whether this genetically engineered potato is likely to pose a plant 
pest risk.

DATES: We will consider any information that we receive on or before 
June 30, 2014.

ADDRESSES: You may submit any information by either of the following 
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067.
     Postal Mail/Commercial Delivery: Send your information to 
Docket No. APHIS-2012-0067, 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-2012-0067 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 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 13-022-01p.

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 has received a petition (APHIS Petition 
Number 13-022-01p) from the J.R. Simplot Company (Simplot) of Boise, 
ID, seeking a determination of nonregulated status of potatoes (Solanum 
tuberosum) designated as InnateTM potatoes (events E12, E24, 
F10, F37, J3, J55, J78, G11, H37, and H50), which have been genetically 
engineered for low acrylamide potential and reduced black spot bruise. 
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 input 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 May 3, 2013 (78 FR 25942-25943, Docket No. APHIS-2012-
0067), APHIS announced the availability of the Simplot petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on July 2, 2013, 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, 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-
2012-0067.
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    APHIS received 308 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 41,475 
comments. Some comments expressed support of a determination of 
nonregulated status because of potential health benefits and 
improvements to the potato industry. Issues raised during the comment 
period include concerns regarding effects on conventional potato 
production, export markets, and plant fitness. 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).
    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 input 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 new crop-
trait GE organism or 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 a 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 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.
    APHIS has prepared a PPRA to determine if InnateTM 
potatoes are 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

[[Page 31082]]

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 InnateTM potatoes and they 
would continue to be a regulated article, or (2) make a determination 
of nonregulated status of InnateTM potatoes. APHIS' 
preferred alternative is to make a determination of nonregulated status 
of InnateTM potatoes.
    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 23rd day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-12555 Filed 5-29-14; 8:45 am]
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