[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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