[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Notices]
[Pages 68300-68301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-3315]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
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  Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / 
Notices  

[[Page 68300]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-085-1]


Monsanto Co. and Forage Genetics International; Availability of 
Petition and Environmental Assessment for Determination of Nonregulated 
Status for Alfalfa Genetically Engineered for Tolerance to the 
Herbicide Glyphosate

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 Monsanto Company and 
Forage Genetics International seeking a determination of nonregulated 
status for alfalfa designated as events J101 and J163, which have been 
genetically engineered for tolerance to the herbicide glyphosate. 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 alfalfa 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 January 
24, 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. 04-085-1, 
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. 04-085-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 04-085-1'' on the subject 
line.
     Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS Web site.
    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, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-3363. To obtain copies of the petition or the 
environmental assessment (EA), contact Ms. Terry Hampton at (301) 734-
5715; e-mail: [email protected]. The petition and the EA 
are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_11001p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_11001p_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 April 16, 2004, APHIS received a petition from Monsanto Company 
of St. Louis, MO, and Forage Genetics International of West Salem, WI 
(Monsanto/FGI), requesting a determination of nonregulated status under 
7 CFR part 340 for alfalfa (Medicago sativa L.) designated as events 
J101 and J163, which have been genetically engineered for tolerance to 
the herbicide glyphosate. The Monsanto/FGI petition states that the 
subject alfalfa should not be regulated by APHIS because it does not 
present a plant pest risk.
    As described in the petition, alfalfa events J101 and J163 have 
been genetically engineered to express a 5-enolpyruvyshikimate-3-
phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 
EPSPS), which confers tolerance to the herbicide glyphosate. Expression 
of the added genes is controlled in part by the 35S promoter derived 
from the plant pathogen figwort mosaic virus. The Agrobacterium 
tumefaciens transformation method was used to transfer the added genes 
into the proprietary alfalfa line R2336.
    Alfalfa events J101 and J163 have been considered regulated article 
under the regulations in 7 CFR part 340 because they contain gene 
sequences from plant pathogens. In the process of reviewing the 
notifications for field trials of the subject alfalfa, 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

[[Page 68301]]

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, Monsanto/FGI are seeking 
registration for the use of glyphosate on glyphosate-tolerant alfalfa 
from the EPA.
    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. EPA is currently 
evaluating the residue tolerance for glyphosate-tolerant alfalfa.
    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, 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. 
Monsanto/FGI has begun consultation with FDA on the subject alfalfa 
event.
    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 Monsanto/
FGI events J101 and J163 alfalfa, an environmental assessment (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 alfalfa 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 Monsanto/FGI glyphosate-tolerant alfalfa 
events J101 and J163 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 18th day of November 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-3315 Filed 11-23-04; 8:45 am]
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