[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32356-32357]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn10-43]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0156]
Pioneer Hi-Bred International, Inc.; Determination of
Nonregulated Status for Genetically Engineered High-oleic Soybeans
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that a soybean
line developed by Pioneer Hi-Bred International, designated as
transformation event 305423, which has been genetically engineered to
have higher levels of oleic acid, and lower levels of linoleic and
linolenic acids in the soybean oil, is no longer considered a regulated
article under our regulations governing the introduction of certain
genetically engineered organisms. Our determination is based on our
evaluation of data submitted by Pioneer Hi-Bred International in its
petition for a determination of nonregulated status, our analysis of
other scientific data, and comments received from the public in
response to our previous notice announcing the availability of the
petition for nonregulated status and its associated environmental
assessment and plant pest risk assessment. This notice also announces
the availability of our written determination and finding of no
significant impact.
EFFECTIVE DATE: June 8, 2010.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received in our reading room. The reading room 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) 690-2817 before coming. Those
documents are also available on the Internet at (http://
www.aphis.usda.gov/brs/not_reg.html) and are posted with the previous
notices and the comments we received on the Regulations.gov Web site at
(http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0156).
Other Information: Additional information about APHIS and its
programs is available on the Internet at (http://www.aphis.usda.gov).
FOR FURTHER INFORMATION CONTACT: Ms. Karen Green, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0672, email: (karen.c.green@aphis.usda.gov). To
obtain copies of the documents referenced in this notice, contact Ms.
Cindy Eck at (301) 734-0667, email: (cynthia.a.eck@aphis.usda.gov).
SUPPLEMENTARY INFORMATION:
Background
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 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. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a
[[Page 32357]]
determination of nonregulated status must take and the information that
must be included in the petition.
On December 20, 2006, APHIS received a petition seeking a
determination of nonregulated status (APHIS Petition No. 06-354-01p)
from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer),
for soybean (Glycine max L.) designated as transformation event 305423,
which has been genetically engineered for higher levels of oleic acid,
a monounsaturated fat in soybean oil, stating that soybean line 305423
does not present a plant pest risk and, therefore, should not be a
regulated article under APHIS' regulations in 7 CFR part 340.
In a notice \1\ published in the Federal Register on September 2,
2009 (74 FR 45413-45415, Docket No. APHIS-2007-0156), APHIS announced
the availability of Pioneer's petition and the associated draft
environmental assessment (EA) and plant pest risk assessment for public
comment. APHIS solicited comments for 60 days ending on November 2,
2009, on whether the genetically engineered soybean is or could be a
plant pest and on the draft EA and the risk assessment. In a subsequent
notice published in the Federal Register on October 26, 2009 (74 FR
54950-54951, Docket No. APHIS-2007-0156), we extended the comment
period until December 28, 2009.
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\1\ To view the notices, petition, EA, risk assessment, and the
comments we received, go to (http://www.regulations.gov/fdmspublic/
component/main?main=DocketDetail&d=APHIS-2007-0156).
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APHIS received 40 comments during the comment period. There were 22
comments from groups or individuals who supported deregulation and 18
from those who opposed deregulation. APHIS has addressed the issues
raised during the comment period and has provided responses to these
comments as an attachment to the finding of no significant impact.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
determination of nonregulated status for Pioneer's 305423 soybean, an
EA has been prepared. The EA was 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). Based on that EA,
the response to public comments, and other pertinent scientific data,
APHIS has reached a finding of no significant impact with regard to the
preferred alternative identified in the EA, i.e., that Pioneer's 305423
soybean line and lines developed from it are granted nonregulated
status and are no longer regulated articles under its regulations in 7
CFR part 340.
Determination
Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Pioneer, references provided in the petition, information
analyzed in the EA, the plant pest risk assessment, comments provided
by the public, and information provided in APHIS' response to those
public comments, APHIS has determined that Pioneer's 305423 soybean is
unlikely to pose a plant pest risk and should be granted nonregulated
status.
Copies of the signed determination document, as well as copies of
the petition, plant pest risk assessment, EA, finding of no significant
impact, and response to comments are available as indicated in the
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.
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 2\nd\ day of June 2010.
Kevin Shea
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-13722 Filed 6-7-10; 6:37 am]
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