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, 38094-38096 [E5-3464]

Download as PDF 38094 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices Please state that your comment refers to Docket No. 05–043–1. Reading Room: You may read 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: For information regarding regulations for the interstate movement of animals affected with Johne’s disease, contact Dr. Michael Carter, Senior Staff Veterinarian, Ruminant Health Programs, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737– 1231; (301) 734–4914. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS’ Information Collection Coordinator, at (301) 734– 7477. SUPPLEMENTARY INFORMATION: Title: Johne’s Disease in Domestic Animals; Interstate Movement. OMB Number: 0579–0148. Type of Request: Extension of approval of an information collection. Abstract: The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture is responsible for, among other things, preventing the spread of serious communicable animal diseases (such as Johne’s disease) from one State to another, and for eradicating such diseases from the United States when feasible. Johne’s disease, also known as paratuberculosis, is caused by Mycobacterium paratuberculosis and primarily affects cattle, sheep, goats, and other domestic, exotic, and wild ruminants. The disease is a chronic and contagious enteritis that results in progressive wasting and eventual death. It is nearly always introduced into a healthy herd by an infected animal that is not showing symptoms of the disease. The regulations in title 9, chapter I, subchapter C of the Code of Federal Regulations govern the interstate movement of animals to prevent the dissemination of livestock and poultry diseases in the United States. Within VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 subchapter C, part 71 contains general provisions for the interstate transportation of animals, poultry, and animal products, while part 80 pertains specifically to the interstate movement of domestic animals that are positive to an official test for Johne’s disease. Our regulations provide that cattle, sheep, goats, and other domestic animals that are positive to an official test for Johne’s disease may generally be moved interstate only to a recognized slaughtering establishment or to an approved livestock facility for sale to such an establishment. The animals must bear an official eartag and be shipped with an owner-shipper statement. We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning this information collection activity. These comments will help us: (1) Evaluate whether the information collection is necessary for the proper performance of our agency’s functions, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the information collection on those who are to respond through use, as appropriate, of automated, electronic, mechanical, or other collection technologies, e.g., permitting electronic submission of responses. Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.20 hours per response. Respondents: Herd owners, shippers, and State representatives. Estimated number of respondents: 250. Estimated number of responses per respondent: 1. Estimated annual number of responses: 250. Estimated total annual burden on respondents: 50 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) All responses to this notice will be summarized and included in the request PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 for OMB approval. All comments will also become a matter of public record. Done in Washington, DC, this 27th day of June 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E5–3463 Filed 6–30–05; 8:45 am] BILLING CODE 3410–34–P 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: 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 E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices 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: michael.t.watson@aphis.usda.gov. To obtain copies of the petition or the environmental assessment (EA), contact Ms. Ingrid Berlanger at (301) 734–4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. 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 § 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 § 340.6 describe the form that a petition for a determination of nonregulated status VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 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 Agrobacteriummediated 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 PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 38095 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, E:\FR\FM\01JYN1.SGM 01JYN1 38096 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices 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 § 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 glyphosatetolerant 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. VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 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 DEPARTMENT OF AGRICULTURE Forest Service Newspapers Used for Publication of Legal Notice of Appealable Decisions for the Northern Region; Northern Idaho, Montana, North Dakota, and portions of South Dakota and Eastern Washington Forest Service, USDA. Notice. AGENCY: ACTION: SUMMARY: This notice lists the newspapers that will be used by all Ranger Districts, Forests, Grasslands, and the Regional Office of the Northern Region to publish legal notices for public comment and decisions subject to appeal and predecisional administrative review under 36 CFR 215, 217, and 218. The intended effect of this action is to inform interested members of the public which newspapers will be used to publish legal notices for public comment or decisions; thereby allowing them to receive constructive notice of a decision, to provide clear evidence of timely notice, and to achieve consistency in administering the appeals process. DATES: Publication of legal notices in the listed newspapers will begin with decisions subject to appeal that are made on or after July 1, 2005. The list of newspapers will remain in effect until another notice is published in the Federal Register. FOR FURTHER INFORMATION CONTACT: Appeals and Litigation Group Leader; Northern Region; P.O. Box 7669; Missoula, Montana 59807. Phone: (406) 329–3696. The newspapers to be used are as follows: Northern Regional Office Regional Forester decisions in Montana: The Missoulian, Great Falls Tribune, and The Billings Gazette. Regional Forester decisions in Northern Idaho and Eastern Washington: The Spokesman Review and Lewiston Morning Tribune. Regional Forester decisions in North Dakota: Bismarck Tribune. Regional Forester decisions in South Dakota: Rapid City Journal. PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 Beaverhead/Deerlodge NF—Montana Standard Bitterroot NF—Ravalli Republic Clearwater NF—Lewiston Morning Tribune Custer NF—Billings Gazette (Montana), Rapid City Journal (South Dakota) Dakota Prairie Grasslands—Bismarck Tribune (North and South Dakota) Flathead NF—Daily Inter Lake Gallatin NF—Bozeman Chronicle Helena NF—Independent Record Idaho Panhandle NFs—Spokesman Review Kootenai NF—Daily Inter Lake Lewis & Clark NF—Great Falls Tribune Lolo NF—Missoulian Nez Perce NF—Lewiston Morning Tribune Supplemental notices may be placed in any newspaper, but time frames/ deadlines will be calculated based upon notices in newspapers of record listed above. Dated: June 27, 2005. Kathleen A. McAllister, Deputy Regional Forester. [FR Doc. 05–13012 Filed 6–30–05; 8:45 am] BILLING CODE 3410–11–M DEPARTMENT OF AGRICULTURE Forest Service Ashley National Forest, Utah; AshleyDry Fork Grazing Allotments Forest Service, USDA. Notice of intent to prepare an environmental impact statement; removal. AGENCY: ACTION: SUMMARY: The Environmental Protection Agency published in the Federal Register of February 3, 2004, a notice of intent to prepare an EIS for the AshleyDry Fork Grazing Allotments. This document removes that notice of intent. DATES: Effective on July 1, 2005. FOR FURTHER INFORMATION CONTACT: Dustin Bambrough, Interdisciplinary Team Leader, Ashley National Forest, 355 N. Vernal Avenue, Vernal, UT 84078–789–1181. SUPPLEMENTARY INFORMATION: The Environmental Protection Agency published in the Federal Register of February 3, 2004 (DOCID:FR03fe04–42), a notice of intent to prepare an EIS for the Ashley-Dry Fork Grazing Allotments to analyze a proposal to continue cattle grazing on the Black Canyon, Lake Mountain and Dry Fork Allotments located on the Vernal Ranger District, in Uintah County. This document removes that notice of intent. The Forest Service is not going to publish an environmental impact statement. E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

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


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

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.

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

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: 
michael.t.watson@aphis.usda.gov. To obtain copies of the petition or 
the environmental assessment (EA), contact Ms. Ingrid Berlanger at 
(301) 734-4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. 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,

[[Page 38096]]

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