[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Pages 32356-32357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13722]



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 


    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: ([email protected]). To 

obtain copies of the documents referenced in this notice, contact Ms. 

Cindy Eck at (301) 734-0667, email: ([email protected]).



    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

[[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.


    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 


    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 


    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]