[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Pages 45413-45415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21277]



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.


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

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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: karen.c.green@aphis.usda.gov. To 
obtain copies of the petition or the draft environmental assessment, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov. 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.



    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 
    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

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(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]