[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58663-58664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20194]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-113-2]


Mycogen Seeds/Dow AgroSciences LLC and Pioneer Hi-Bred 
International Inc.; Availability of Determination of Nonregulated 
Status for Genetically Engineered Corn

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
Mycogen Seeds/Dow AgroSciences LLC and Pioneer Hi-Bred International 
Inc. corn designated as corn line DAS-59122-7, which has been 
genetically engineered for resistance to a corn rootworm complex and 
for tolerance to the herbicide glufosinate, 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 Mycogen Seeds/Dow AgroSciences LLC 
and Pioneer Hi-Bred International Inc. in their petition for a 
determination of non-regulated 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 an environmental assessment. This notice also announces the 
availability of our written determination and our finding of no 
significant impact.

DATE: Effective September 23, 2005.

FOR FURTHER INFORMATION CONTACT: Dr. Michael Watson, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0486; e-mail: [email protected]. To 
obtain copies of the petition or, the determination, the environmental 
assessment (EA), or the finding of no significant impact (FONSI) 
contact Ms. Ingrid Berlanger at (301) 734-4885; e-mail: 
[email protected]. The petition and the EA, including 
the FONSI and determination, are also available on the Internet at 
http://www.aphis.usda.gov/brs/aphisdocs/03_35301p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_35301p_ea.pdf.

SUPPLEMENTARY INFORMATION: 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 19, 2003, APHIS received a petition (APHIS No. 03-353-
01p) from Mycogen Seeds/Dow AgroSciences LLC of Indianapolis, IN, and 
Pioneer Hi-Bred International of Johnston, IA (Dow AgroSciences/
Pioneer), requesting a determination of nonregulated status under 7 CFR 
part 340 for corn (Zea mays) designated as corn line DAS-59122-7, which 
has been genetically engineered for resistance to corn rootworm and for 
tolerance to the herbicide glufosinate. The Dow AgroSciences/Pioneer 
petition states that the subject corn should not be regulated by APHIS 
because it does not present a plant pest risk.
    In a notice published in the Federal Register on July 1, 2005 (70 
FR 38094-38096, Docket No. 04-113-1), APHIS announced the availability 
of the Dow AgroSciences/Pioneer petition and an environmental 
assessment (EA). APHIS solicited comments on whether the subject corn 
would present a plant pest risk and on the environmental assessment. 
The notice also discussed the role of APHIS, the Environmental 
Protection Agency, and the Food and Drug Administration in regulating 
the subject corn and products developed from it.
    APHIS received two comments by the close of the comment period on 
August 30, 2005. One comment was from a trade association, which 
supported the petition. The other comment was from a private individual 
who did not support the petition. The response to these comments can be 
found in an attachment to the finding of no significant impact (FONSI).
    APHIS has amended the section of the EA titled ``Potential impacts 
on threatened and endangered arthropods.'' The amended section includes 
a reference to a process for assessment of impacts on threatened and 
endangered species that has been mutually agreed upon by the U.S. Fish 
and Wildlife Service and APHIS. The change in language merely provides 
clarity to the reader; it is not substantive and did not change the 
analysis described in the EA.
    As described in the petition, corn line DAS-59122-7 has been 
genetically engineered to express a plant incorporated protectant (PIP) 
that controls certain corn rootworm. The PIP is an insecticidal crystal 
protein (ICP) from Bacillus thuringiensis strain PS149B1. The ICP is 
made of two proteins Cry34Ab1, approximately 14 kDa, and Cry35Ab1, 
approximately 44 kDa in molecular weight. Transcription of the Cry34Ab1 
coding sequence is controlled by the maize ubiquitin promoter (UBI1ZM 
PRO). Transcription of Cry35Ab1 is controlled by a wheat (Triticum 
aestivum) peroxidase (TA Peroxidase) promoter. The termination 
sequences for these two genes were derived from the potato (Solanum 
tuberosum) proteinase inhibitor II (PINII). The PIP is expressed 
throughout the plant and confers resistance to northern corn rootworm 
(nCRW), western corn rootworm (wCRW), and Mexican corn rootworm (mCRW).
    Corn line DAS-59122-7 has also been genetically engineered to 
express the enzyme phosphinothricin acetyltransferase (PAT), which 
confers tolerance to the herbicide glufosinate. The expression of the 
pat gene, derived from the bacterium Streptomyces viridochromogenes, is 
under the control of the cauliflower mosaic virus (CaMV) 35S RNA 
promoter and a CaMV termination sequence (CaMV35S TERM). The DAS-59122-
7 corn line was generated through Agrobacterium-mediated transformation 
of the publicly available corn line Hi-II.

Determination

    Based on its analysis of the data submitted by Dow AgroSciences/
Pioneer, a review of other scientific data, field tests of the subject 
corn, and the comments submitted by the public, APHIS has determined 
the following with respect to corn line DAS-59122-7: (1) It exhibits no 
plant pathogenic properties; although a plant pathogen was used in the 
development of this

[[Page 58664]]

corn, these plants are not infected by this organism, nor do they 
contain genetic material from this pathogen that can cause plant 
disease; (2) it exhibits no characteristics that would cause it to be 
more weedy than the non-transgenic parent corn line or other cultivated 
corn; (3) gene introgression from DAS-59122-7 corn into wild relatives 
in the United States and its territories is extremely unlikely and is 
not likely to increase the weediness potential of any resulting progeny 
nor adversely affect genetic diversity of related plants any more than 
would introgression from traditional corn hybrids; (4) disease and 
insect susceptibility and compositional profiles of the kernel is 
similar to non-transgenic corn and should have no adverse impact on raw 
or processed agricultural commodities; (5) it exhibits no potential to 
have significant adverse impact on organisms beneficial to agriculture; 
(6) compared to current agricultural practices, cultivation of DAS-
59122-7 should not reduce the ability to control pests and weeds in 
corn or other crops. In addition to our finding of no plant pest risk, 
there will be no effect on threatened or endangered species resulting 
from a determination of non-regulated status for DAS-59122-7 and its 
progeny.
    Therefore, APHIS has concluded that the subject corn and any 
progeny derived from hybrid crosses with other non-transformed corn 
varieties will be as safe to grow as corn varieties in traditional 
breeding programs that are not subject to regulation under 7 CFR part 
340. The effect of this determination is that Dow AgroSciences/Pioneer 
corn line DAS-59122-7 is no longer considered a regulated article under 
APHIS' regulations in 7 CFR part 340.
    Therefore, the requirements pertaining to regulated articles under 
those regulations no longer apply to the subject corn or its progeny. 
However, importation of corn line DAS-59122-7 and seeds capable of 
propagation are still subject to the restrictions found in APHIS' 
foreign quarantine notices in 7 CFR part 319 and imported seed 
regulations in 7 CFR part 361.

National Environmental Policy Act

    An EA was prepared to examine any potential environmental impacts 
and plant pest risk associated with the determination of nonregulated 
status for the Dow AgroSciences/Pioneer corn line DAS-59122-7. 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, APHIS has reached a FONSI with regard to the 
determination that Dow AgroSciences/Pioneer corn line DAS-59122-7 and 
lines developed from it are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the EA and FONSI are available 
from the individual listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice.

    Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Done in Washington, DC, this 3rd day of October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-20194 Filed 10-6-05; 8:45 am]
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