```

[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]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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]
BILLING CODE 3410-34-S
```