[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45413-45415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21277]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0156]
Pioneer Hi-Bred International, Inc.; Availability of Petition and
Environmental Assessment for 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 that the Animal and Plant Health
Inspection Service has received a petition from Pioneer Hi-Bred
International, Inc., seeking a determination of nonregulated status for
soybean designated as transformation
[[Page 45414]]
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. The petition has been submitted in accordance with
our regulations concerning the introduction of certain genetically
engineered organisms and products. In accordance with those
regulations, we are soliciting comments on whether this genetically
engineered soybean is or could be a plant pest. We are also making
available for public comment an environmental assessment for the
proposed determination of nonregulated status.
DATES: We will consider all comments we receive on or before November
2, 2009.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0156 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2007-0156, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2007-0156.
Reading Room: You may read any comments that we receive on this
docket 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mrs. Karen Green, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0672, e-mail: [email protected]. To
obtain copies of the petition or the draft environmental assessment,
contact Ms. Cindy Eck at (301) 734-0667, e-mail:
[email protected]. The petition, the draft environmental
assessment, and the plant pest risk assessment are also available on
the Internet at http://www.aphis.usda.gov/brs/aphisdocs/06_35401p.pdf,
http://www.aphis.usda.gov/brs/aphisdocs/06_35401p_ea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/06_35401p_pra.pdf.
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 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.
As described in the petition, 305423 soybean has been genetically
engineered to suppress the expression of the soybean endogenous
microsomal omega-6 desaturases gene (FAD2-1). The introduced endogenous
FAD2-1 gene fragment acts to silence expression of the endogenous FAD2-
1 gene, which is responsible for an increased level of oleic acid and
decreased levels of linoleic acid, a major polyunsaturated fatty acid
present in soybean oil.
In addition, Pioneer 305423 soybean contains a slightly modified
version of an endogenous acetolactate synthase gene (ALS). Expression
of the protein can increase the inherent tolerance level to the ALS-
inhibiting class of herbicides. This trait is intended for selecting
and identifying this bioengineered event, rather than as a separate
commercial trait as this version of the gene does not confer commercial
levels of herbicide tolerance in Pioneer 305423 soybean.
APHIS has prepared an environmental assessment (EA) that presents
two alternatives based on APHIS' analyses of data submitted by Pioneer,
a review of other scientific data, and information obtained during
field tests conducted under APHIS oversight. APHIS may either: (1) Take
no action, i.e., APHIS would not change the regulatory status of 305423
soybeans and they would continue to be regulated articles, or (2)
deregulate 305423 soybeans in whole.
Section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.),
defines ``plant pest'' 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 views this plant pest definition broadly to cover
direct or indirect injury, disease, or damage not just to agricultural
crops, but also to other plants, for example, native species, as well
as organisms that may be beneficial to plants, such as honeybees.
The FDA's policy statement concerning regulation of products
derived from new plant varieties, including those genetically
engineered, was published in the Federal Register on May 29, 1992 (57
FR 22984-23005). Under this policy, FDA uses what is termed a
consultation process to ensure that human and animal feed safety issues
or other regulatory issues (e.g., labeling) are resolved prior to
commercial distribution of a bioengineered food. Pioneer submitted a
food and feed safety and nutritional assessment summary to the FDA for
305423 soybeans. On January 15, 2009, the FDA concluded their review of
the data submitted by Pioneer and had no further questions regarding
the safety of 305423 soybean.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
proposed determination of nonregulated status for 305423 soybeans, an
EA has been prepared. The EA was prepared in accordance with: (1) The
National Environmental Policy Act of 1969
[[Page 45415]]
(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 7 CFR 340.6(d), we are publishing this notice to
inform the public that APHIS will accept written comments regarding the
petition for a determination of nonregulated status from interested or
affected persons for a period of 60 days from the date of this notice.
During the same comment period, we are also soliciting written comments
from interested or affected persons on the plant pest risk assessment
and on the EA prepared to examine any environmental impacts of the
proposed deregulation determination for the subject soybean event. The
petition, plant pest risk assessment, EA, and any comments we receive
are available for public review, and copies of the petition, plant pest
risk assessment, and EA are available as indicated in the FOR FURTHER
INFORMATION CONTACT section of this notice.
After the comment period closes, APHIS will review all written
comments received during the 60-day comment period and any other
relevant information. All public comments received regarding the
petition, plant pest risk assessment, and draft EA will be available
for public review. After reviewing and evaluating the comments on the
petition, plant pest risk assessment, draft EA, and other data, APHIS
will furnish a response to the petitioner, either approving in whole or
denying the petition. APHIS will then publish a notice in the Federal
Register announcing the regulatory status of Pioneer's 305423 soybean
and the availability of APHIS' written decision.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.8, and 371.3.
Done in Washington, DC, this 26th day of August 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-21277 Filed 8-31-09; 11:15 am]
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