[Federal Register: July 24, 2008 (Volume 73, Number 143)]
[Notices]               
[Page 43203-43205]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy08-39]                         

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0019]

 
Pioneer Hi-Bred International, Inc.; Determination of 
Nonregulated Status for Soybean Genetically Engineered for Tolerance to 
Glyphosate and Acetolactate Synthase-Inhibiting Herbicides

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, Inc., designated as 
transformation event 356043, which has been genetically engineered for 
tolerance to glyphosate and acetolactate synthase-inhibiting 
herbicides, 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 the Pioneer Hi-Bred International, Inc., in its 
petition for a determination of nonregulated status, our analysis of 
other scientific data, and comments received from the public in 
response to a previous notice announcing the availability of the 
petition for nonregulated status and its associated environmental 
assessment. This notice also announces the availability of our written 
determination and finding of no significant impact.

DATES: Effective Date: July 24, 2008.

ADDRESSES: You may read the petition, environmental assessment, 
determination, finding of no significant impact, the comments we 
received on our previous notice, and our responses to those comments 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. To view those documents on 
the Internet, go to http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0019.

FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301)

[[Page 43204]]

734-5531, john.m.cordts@aphis.usda.gov. To obtain copies of the 
petition, environmental assessment, or the finding of no significant 
impact, contact Ms. Cynthia Eck at (301) 734-0667; e-mail: 
cynthia.a.eck@aphis.usda.gov. Those documents are also available on the 
APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/06_
27101p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/06_27101p_
ea.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 September 28, 2006, APHIS received a petition seeking a 
determination of nonregulated status (APHIS petition number 06-271-01p) 
from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), 
for soybean (Glycine max L.) designated as transformation event 356043, 
which has been genetically engineered for tolerance to glyphosate and 
acetolactate synthase (ALS)-inhibiting herbicides, stating that soybean 
line 356043 does not present a plant pest risk.

Analysis

    As described in the petition, 356043 soybean plants have been 
genetically engineered to express modified glyphosate acetyltransferase 
(GAT 4601) and ALS proteins, which confers tolerance to glyphosate and 
ALS-inhibiting herbicides. The gat4601 gene is derived from gat genes 
from Bacillus licheniformis, a common soil bacterium. Expression of the 
gat4601 gene is driven by a synthetic constitutive promoter (SCP1). The 
gene that confers tolerance to ALS-inhibiting herbicides is gm-hra and 
is a modified soybean ALS gene. Expression of the gm-hra gene is driven 
by a constitutive soybean S-adenosyl-L-methionine synthetase (SAMS) 
promoter. A single copy of these genes and their regulatory sequences 
were introduced into soybean somatic embryos using microprojectile 
bombardment.
    Pioneer's 356043 soybean plants have been considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences from plant pathogens. Pioneer's 356043 soybean plants 
have been field tested in the United States since 2003 under permits 
issued by APHIS. In the process of reviewing the permits for field 
trials of the subject soybean plants, APHIS determined that the vectors 
and other elements were disarmed and that trials, which were conducted 
under conditions of reproductive and physical confinement or isolation, 
would not present a risk of plant pest introduction or dissemination.
    In a notice \1\ published in the Federal Register on October 5, 
2007 (72 FR 56981-56983, Docket No. APHIS-2007-0019), APHIS announced 
the availability of the Pioneer petition and a draft environmental 
assessment (EA) for public comment. APHIS solicited public comments on 
whether the subject soybean would present a plant pest risk and on the 
EA. APHIS received 110 comments by the close of the 60-day comment 
period, which ended on December 4, 2007. There were 18 comments 
submitted in support of the petition to grant nonregulated status to 
356043 soybean plants and 92 that were opposed. APHIS' responses to 
these comments can be found as an attachment to the finding of no 
significant impact.
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    \1\ To view the notice, the EA, and the comments we received, go 
to http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0019.
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Determination

    Based on APHIS' analysis of field, greenhouse, and laboratory data 
submitted by Pioneer, references provided in the petition, other 
relevant information described in the EA, and comments provided by the 
public, APHIS has determined that 356043 soybean will not pose a plant 
pest risk for the following reasons: (1) Gene introgression from 356043 
soybean into wild relatives in the United States and its territories is 
extremely unlikely; (2) APHIS does not expect 356043 soybean to have 
any impacts on non-target organisms, including beneficial organisms and 
threatened or endangered species, because all the studies conducted on 
356043 soybean and specific proteins show no evidence of toxicity and 
GAT4601 and GM-HRA protein assessments showed low likelihood of 
allergenicity; (3) soybean (Glycine max) is not considered to be a weed 
and it does not persist in unmanaged ecosystems; (4) APHIS does not 
expect cultivation of 356043 soybean to have significant impacts on 
non-target organisms, including beneficial organisms and threatened or 
endangered species, as a result of the use of EPA-registered glyphosate 
and ALS-inhibitor herbicides as these have been used safely on soybeans 
for many years; (5) analysis of available information demonstrates that 
356043 soybean does not exhibit any traits that should cause increased 
weediness, and that its unconfined cultivation should not lead to 
increased weediness of other sexually compatible relatives (of which 
there are none in the United States); (6) if 356043 soybeans were to be 
grown commercially, the effects on agricultural practices (e.g., 
cultivation, spray programs, crop rotation practices, planting rates, 
etc.) from introducing 356043 soybean into the environment should not 
be significantly different than previously deregulated glyphosate 
tolerant or RR[supreg]/STS[supreg] soybean lines; (7) APHIS does not 
expect 356043 soybean to cause significant impact on the development of 
herbicide tolerant weeds or cumulative impacts in combination with 
other glyphosate tolerant or Roundup Ready[supreg]/STS[supreg] 
(sulfonylurea tolerant soybean) crops; (8) if 356043 soybean were to be 
grown commercially, APHIS expects 356043 soybean will be used to breed 
soybean varieties suitable to a range of environments and maturity 
zones and replace some of the presently available glyphosate and ALS-
inhibitor tolerant soybeans; deregulation of 356043 soybean should not 
alter the current potential impact to organic farming, organic farmers 
will still be able to purchase and grow non-transgenic soybeans and 
will be able to coexist with biotech soybean producers as they do now; 
(9) APHIS' analysis of agronomic performance, disease and insect 
susceptibility, and compositional profiles of 356043 soybean and its 
non-genetically engineered counterpart indicates no significant 
differences in composition between the two that would be expected to 
cause significant effects on raw or processed plant commodities from 
the deregulation of

[[Page 43205]]

356043 soybean; and (10) when considered in light of other past, 
present, and reasonably foreseeable future actions, and considering 
potential environmental effects associated with adoption of 356043 
soybean, APHIS could not identify significant environmental impacts 
that would result from granting nonregulated status to 356043 soybean.

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 356043 soybeans, an EA was 
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 
and other pertinent scientific data, APHIS has reached a finding of no 
significant impact with regard to the determination that Pioneer 356043 
soybean line and lines developed from it are no longer regulated 
articles under its regulations in 7 CFR part 340. Copies of the EA and 
finding of no significant impact 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 18th day of July, 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-16950 Filed 7-23-08; 8:45 am]

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