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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: June 27, 2005 (Volume 70, Number 122)]
[Notices]
[Page 36917-36919]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn05-31]

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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-085-3]
 
Monsanto Co. and Forage Genetics International; Availability 
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 of our determination that the 
Monsanto Company and Forage Genetics International alfalfa lines 
designated as events J101 and J163, which have been genetically 
engineered for tolerance to the herbicide glyphosate, are no longer 
considered regulated articles under our

[[Page 36918]]

regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by Monsanto Company and Forage Genetics International in 
their 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 an environmental assessment. This 
notice also announces the availability of our written determination 
document and our finding of no significant impact.

EFFECTIVE DATE: June 14, 2005.

ADDRESSES: You may read the petition for a determination of 
nonregulated status submitted by Monsanto Company and Forage Genetics 
International, the environmental assessment, all comments received on 
the petition and the environmental assessment, the determination, and 
the finding of no significant impact with attached response to 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.
    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. Exit Disclaimer

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, the 
determination, the environmental assessment, or the finding of no 
significant impact, contact Ms. Ingrid Berlanger, at (301) 734-4885; e-
mail: ingrid.e.berlanger@aphis.usda.gov. Those documents are also 
available on the Internet at 
http://www.aphis.usda.gov/brs/aphisdocs/04_11001p.pdf Exit Disclaimer and 
http://www.aphis.usda.gov/brs/aphisdocs/04_11001p_ea.pdf. Exit Disclaimer

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 (APHIS petition number 
04-110-01p) 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.
    On November 24, 2004, APHIS published a notice in the Federal 
Register (69 FR 68300-68301, Docket No. 04-085-1) announcing that the 
Monsanto/FGI petition and an environmental assessment were available 
for public review and soliciting comments for 60 days ending January 
24, 2005. The notice also discussed the role of APHIS, the 
Environmental Protection Agency, and the Food and Drug Administration 
in regulating the subject alfalfa and products developed from it. In a 
subsequent notice, APHIS extended the comment period until February 17, 
2005 (see 70 FR 5601-5602, Docket No. 04-085-2, published February 3, 
2005).
    APHIS received 663 comments by the close of the extended comment 
period. Comments came from alfalfa growers and seed producers, organic 
growers, animal producers, growers associations, consumer groups, 
agriculture support industries, university professionals, and private 
citizens. Five hundred twenty respondents did not support granting 
nonregulated status to the events identified in the petition, while 137 
supported the petition. The majority of the alfalfa growers and seed 
producers who submitted comments supported granting nonregulated status 
to alfalfa events J101 and J163, citing market demand for a weed-free 
product and stating that glyphosate tolerant alfalfa offered a tool to 
meet that demand. The majority of those academic professionals, 
agricultural support industries, and growers associations that 
submitted comments also supported the petition. Those commenters who 
did not support the petition raised concerns that certain domestic and 
foreign markets may be closed to growers who cannot guarantee a non-
genetically engineered product. Organic growers generally opposed the 
petition because of concerns that pollination of their crops by the 
glyphosate tolerant variety will result in the inadvertent generation 
of unwanted genetically engineered products, resulting in market loss.
    APHIS has carefully considered these comments and suggestions, and 
a response to the issues raised in the comments is included as an 
attachment to the finding of no significant impact.
    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 
articles 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.

Determination

    Based on its analysis of the data submitted by Monsanto/FGI, a 
review of other scientific data, field tests of the subject alfalfa, 
and comments submitted by the public, APHIS has determined that alfalfa 
events J101 and J163: (1) Exhibit no plant pathogenic properties; (2) 
are no more likely to become weedy than the nontransgenic parental line 
or other cultivated alfalfa; (3) are unlikely to increase the weediness 
potential of any other cultivated or wild species with which it can 
interbreed; (4) will not cause damage to raw or processed agricultural 
commodities; (5) will not harm threatened or endangered species or 
organisms that are beneficial to agriculture; and (6) should not reduce

[[Page 36919]]

the ability to control pests and weeds in alfalfa or other crops. 
Therefore, APHIS has concluded that the subject alfalfa and any progeny 
derived from hybrid crosses with other non-transformed alfalfa 
varieties will be as safe to grow as alfalfa varieties in traditional 
breeding programs that are not subject to regulation under 7 CFR part 340.
    The effect of this determination is that Monsanto/FGI alfalfa 
events J101 and J163 are no longer considered regulated articles under 
APHIS' regulations in 7 CFR part 340. Therefore, the requirements 
pertaining to regulated articles under those regulations no longer 
apply to the subject alfalfa or its progeny. However, importation of 
J101 and J163 alfalfa 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 environmental assessment was prepared to examine any potential 
environmental impacts associated with the determination of nonregulated 
status for the subject alfalfa events. The environmental assessment 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 environmental assessment, 
APHIS has reached a finding of no significant impact with regard to the 
determination that Monsanto/FGI J101 and J163 alfalfa events and lines 
developed from them are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the environmental assessment 
and the finding of no significant impact are available from the 
individual listed under FOR FURTHER INFORMATION CONTACT.

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

    Dated: Done in Washington, DC, this 21st day of June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3323 Filed 6-24-05; 8:45 am]
BILLING CODE 3410-34-P

 
 

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