Last Updated on 6/23/00
By Karen Lutz
Email: karen@biotech-info.net
Federal Register Notice DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 99-036-2] Monsanto Co.; Extension of Determination of Nonregulated Status for Potato Genetically Engineered for Insect and Virus Resistance AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our decision to extend to one additional potato line our determination that certain potato lines developed by Monsanto Company, which have been genetically engineered for insect and virus resistance, are no longer considered regulated articles under our regulations governing the introduction of certain genetically engineered organisms. Our decision is based on our evaluation of data submitted by Monsanto Company in its request for an extension of a determination of nonregulated status, an analysis of other scientific data, and comments received from the public in response to a previous notice. This notice also announces the availability of our finding of no significant impact. EFFECTIVE DATE: July 17, 2000. ADDRESSES: The extension request, an environmental assessment and finding of no significant impact, and all comments received may be read at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 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. FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology Assessments Section, Permits and Risk Assessments, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734- 5940. To obtain a copy of the extension request or the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail: kay.peterson@usda.gov. 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. Further, the regulations in Sec. 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question. Background
On June 22, 1999, APHIS received a request for an extension of a
determination of nonregulated status (APHIS No. 99-173-01p) from
Monsanto Company (Monsanto) of St. Louis, MO, for a Russet Burbank
potato line designated as NewLeaf
On March 6, 2000, APHIS published a notice in the Federal Register
(65 FR 11758-11759, Docket No. 99-036-1) announcing that an
environmental assessment for Monsanto's extension request had been
prepared and was available for public comment. During the designated
30-day public comment period, APHIS received 10 comments from the
following sources: State potato commissions, a potato growers
association, an organic consumers association, the U.S. Department of
Agriculture's Agricultural Research Service, a State university, a
State university agricultural experiment station, plant virologists, a
farmer, and a private individual. Six of the comments were in favor of
the extension request, and four were in opposition. A majority of the
commenters expressing support for deregulating potato line RBMT22-82
stressed its effectiveness in resisting the damage caused by CPB and
PLRV and the associated benefits of reduced pesticide use. Several
commenters in opposition to deregulation of the subject potato line
expressed concern that insufficient safety testing had been done on
such issues as genetic drift, the development of insect resistance,
effects on beneficial organisms, and the potential for the development
of novel plant viruses through expression of parts of viruses from a
transgene. APHIS identified and addressed these issues in the
environmental assessment prepared for line RBMT22-82 and in the
environmental assessment and determination prepared for the antecedent
organism. In consideration of the comments submitted to us, we have
included a response to comments as an attachment to our finding of no
significant impact (FONSI) for the environmental assessment. The
environmental assessment and the FONSI, including the attachment, are
available from the person listed under FOR FURTHER INFORMATION CONTACT.
Analysis
Like the antecedent organism, potato line RBMT22-82 contains the
cry3A gene derived from Bacillus thuringiensis subsp. tenebrionis (Btt)
and the orf1/orf2 gene derived from PLRV. The cry3A gene encodes an
insecticidal protein that is effective against CPB and the orf1/orf2
gene imparts resistance to PLRV. Potato line RBMT22-82 also contains
the CP4 EPSPS selectable marker gene, while the antecedent organism
contained the nptII selectable marker gene. The subject potato line and
the antecedent organism were developed through use of the Agrobacterium
tumefaciens transformation system, and expression of the added genes in
RBMT22-82 and the antecedent organism is controlled in part by gene
sequences derived from the plant pathogens figwort mosaic virus and A.
tumefaciens.
Potato line RBMT22-82 and the antecedent organism were genetically
engineered using the same transformation method and with the same genes
that make the plants insect and virus resistant. Accordingly, we have
determined that RBMT22-82 is similar to the antecedent organism RBMT21-
129 in APHIS petition 97-204-01p and, therefore, should no longer be
regulated under the regulations in 7 CFR part 340.
The subject potato line has been considered a regulated article
under APHIS' regulations in 7 CFR part 340 because it contains gene
sequences derived from plant pathogens. However, evaluation of field
data reports from field tests of RBMT22-82, conducted under APHIS
permits and notifications since 1994, indicates that there were no
deleterious effects on plants, nontarget organisms, or the environment
as a result of its environmental release.
Determination
Based on an analysis of the data submitted by Monsanto, a review of
other scientific data, and field tests of the subject potato line,
APHIS has determined that Russet Burbank potato line RBMT22-82: (1)
Exhibits no plant pathogenic properties; (2) is no more likely to
become a weed than similar pest-resistant potatoes developed by
traditional breeding techniques; (3) is unlikely to increase the
weediness potential for any other cultivated or wild species with which
it can interbreed; (4) will not cause damage to raw or processed
agricultural commodities; and (5) will not harm threatened or
endangered species or other organisms, such as bees, that are
beneficial to agriculture. Therefore, APHIS has concluded that potato
line RBMT22-82 and any progeny derived from crosses with other potato
varieties will be as safe to grow as potatoes that are not subject to
regulation under 7 CFR part 340.
Because APHIS has determined that potato line RBMT22-82 does not
present a plant pest risk based on its similarity to the antecedent
organism, Monsanto's potato line RBMT22-82 will no longer be 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 field testing, importation, or
interstate movement of the subject potato line or its progeny. However,
importation of potato line RBMT22-82 and seeds capable of propagation
are still subject to the restrictions found in APHIS' foreign
quarantine notices in 7 CFR part 319.
National Environmental Policy Act
An environmental assessment (EA) was prepared to examine the
potential environmental impacts associated with this determination. 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 finding of no significant impact (FONSI) with regard to its
determination that Monsanto's potato line RBMT22-82 and lines developed
from it are no longer regulated articles under its regulations in 7 CFR
part 340. Copies of the EA and the FONSI are available upon request
from the individual listed under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 9th day of June 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-15152 Filed 6-14-00; 8:45 am]
BILLING CODE 3410-34-P
** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material
is distributed for research and educational purposes only. **
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Last Updated on 6/23/00 By Karen Lutz Email: karen@biotech-info.net |
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