[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Notices]
[Pages 38094-38096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-3464]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-113-1]


Mycogen Seeds/Dow AgroScience LLC and Pioneer Hi-Bred 
International Inc.; Availability of Petition and Environmental 
Assessment for 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 that the Animal and Plant Health 
Inspection Service has received a petition from Mycogen Seeds/Dow 
AgroScience LLC and Pioneer Hi-Bred International Inc seeking a 
determination of nonregulated status for 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. 
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 
public comments on whether this corn presents a plant pest risk. 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 August 30, 
2005.

ADDRESSES: You may submit comments by any of the following methods:
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-113-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-113-1.
     EDOCKET: Go to http://www.epa.gov/feddocket to submit or 
view public comments, access the index listing of the contents of the 
official

[[Page 38095]]

public docket, and to access those documents in the public docket that 
are available electronically. Once you have entered EDOCKET, click on 
the ``View Open APHIS Dockets'' link to locate this document.
    Reading Room: You may read the petition, the environmental 
assessment, and 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: You may view APHIS documents published in the 
Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Michael Watson, Biotechnology 
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0486; email: 
[email protected]. To obtain copies of the petition or 
the environmental assessment (EA), contact Ms. Ingrid Berlanger at 
(301) 734-4885; e-mail: [email protected]. The petition 
and the EA 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 DowAgroSciences/Pioneer 
petition states that the subject corn should not be regulated by APHIS 
because it does not present a plant pest risk.
    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 14kDa, and Cry35Ab1, 
approximately 44 kDa in molecular weight. Transcription of the Cry 
34Ab1 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.
    Corn line DAS-59122-7 has been considered regulated article under 
the regulations in 7 CFR part 340 because it contains gene sequences 
from a plant pathogen. In the process of reviewing the notifications 
for field trials of the subject corn, APHIS determined that the vectors 
and other elements were disarmed and that the 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 section 403 of the Plant Protection Act (7 U.S.C. 7701-7772), 
plant pest is defined 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 definition very broadly. The definition 
covers direct or indirect injury, disease, or damage not just to 
agricultural crops, but also to plants in general, for example, native 
species, as well as to organisms that may be beneficial to plants, for 
example, honeybees, rhizobia, etc.
    The U.S. Environmental Protection Agency (EPA) is responsible for 
the regulation of pesticides under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including herbicides, be registered prior 
to distribution or sale, unless exempt by EPA regulation. In cases in 
which genetically modified plants allow for a new use of a pesticide or 
involve a different use pattern for the pesticide, EPA must approve the 
new or different use. Accordingly, DowAgroSciences/Pioneer has 
submitted a request to EPA for Section 3 Registration of the Cry34/
Cry35 ICP construct as a plant incorporated protectant in corn.
    When the use of the pesticide on the genetically modified plant 
would result in an increase in the residues in a food or feed crop for 
which the pesticide is currently registered, or in new residues in a 
crop for which the pesticide is not currently registered, establishment 
of a new tolerance or a revision of the existing tolerance would be 
required. Residue tolerances for pesticides are established by EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA) 
enforces tolerances set by EPA under the FFDCA. DowAgroSciences/Pioneer 
has submitted a request to EPA for a tolerance exemption for Cry34/
Cry35 ICP as expressed in the subject corn events.
    FDA published a statement of policy on foods derived from new plant 
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
The FDA statement of policy includes a discussion of FDA's authority 
for ensuring food safety under the FFDCA,

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and provides guidance to industry on the scientific considerations 
associated with the development of foods derived from new plant 
varieties, including those plants developed through the techniques of 
genetic engineering. DowAgroSciences/Pioneer has completed consultation 
with FDA on the subject corn event (BNF No. 81, http://
www.cfsan.fda.gov//rd/biocon.html).
    To provide the public with documentation of APHIS' review and 
analysis of the environmental impacts and plant pest risk associated 
with a proposed determination of nonregulated status for the 
DowAgroSciences/Pioneer corn line DAS-59122-7, 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).
    In accordance with Sec.  340.6(d) of the regulations, 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 persons for a period of 60 days 
from the date of this notice. We are also soliciting written comments 
from interested persons on the EA prepared to examine any environmental 
impacts of the proposed determination for the subject corn event. The 
petition and the EA and any comments received are available for public 
review, and copies of the petition and the EA are available as 
indicated in the FOR FURTHER INFORMATION CONTACT section of this 
notice.
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. After reviewing and 
evaluating the comments on the petition and the EA and other data and 
information, APHIS will furnish a response to the petitioner, either 
approving the petition in whole or in part, or denying the petition. 
APHIS will then publish a notice in the Federal Register announcing the 
regulatory status of the DowAgroSciences/Pioneer glyphosate-tolerant 
corn line DAS-59122-7 and the availability of APHIS' written decision.

    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 27th day of June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3464 Filed 6-30-05; 8:45 am]
BILLING CODE 3410-34-P