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July 6, 2000


EPA approves Monsanto's GE potato


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-----Original Message-----
From: jill davies [mailto:rivercare@blackfoot.net]
Sent: Friday, July 07, 2000 3:40 AM
To: biotech_activists@iatp.org; ban@lists.tao.ca;
Subject: BAN: RE: EPA approves Monsanto's GE potato

Biotech folks -
The potato recently approved (see below) has the Figwort mosaic
instead of the Cauliflower mosaic virus. I asked Mae-wan Ho for
information about the behavior of the former and here is what she sent.
Thanks to Maewan for all her great work.
[for more info on CaMV see www.i-sis.org]

= = = = = =

Here's a quick reply that I pass on from Prof. Joe cummins. The main thing
is that the Figwort Mosaic Virus promoter is very similar to the CaMV
promoter, and it has not been proved to be safe beyond reasonable doubt.
One effective way to fight this is to opt for organic and boycott
non-organic. The other is to complain loudly to your EPA. Please circulate
as widely as you like.
Best wishes, Maewan

July 6, 2000
Prof. Joe Cummins
e-mail: jcummins@julian.uwo.ca

"Figwort Mosaic Virus Promoter"

Figwort mosaic virus (FiMV) is caulimovirus of the pararetrovirus group, it
is very similar to cauliflower mosaic virus(CaMV). FiMV has been sequenced
and found to have eight ORFs , seven of which correspond in size and
location to loci in CaMV. Like CaMV , FiMV employs methionine t-RNA as
initiator of replication(Richins et al 1987). Plant expression vectors have
been developed using FiMV (Matai et al 1997).
The Promoter of FiMV has been characterized and found to be constitutive
in most all plant tissues, its strength ic comparable or somewhat stronger
than CaMV promoter and much stronger than the nopoline promoter (Sanger et
al 1990 and Matai et al 1997). The FiMV promoter has double enhancers and
eliminating one enhancer reduces activity 75%. FiMV has polyA signals
similar to CaMV and quite different from animal polA signals.
In conclusion, FiMV promoter is a useful alternative to CaMV promoter in
crop genetic engineering.
Maiti,I,Gowda,S,Kiernan,J,Ghosh,S and Shepherd,R "Promoter/leader deletion
analysis and plant expression vectors with the figwort mosaic virus full
length transcript promoter containing single or double enhancer domains"1997
Transgenic Res. 6,143-56
Richins,R,Scholtof,H and Shepherd,R "Sequence of figwort mosaic virus" 1987
Nucl Acids Res 15,8451-66
Sanfacon,H "Analysis of figwort mosaic virus polyadenylation signal" 1994
Virology 198,39-49
Sanger,M,Daubert,S and Goodman,R " Characteristics of a strong promoter from
figwort mosaic virus: comparison with the analougous 35s promoter from
cauliflower mosaic virus and the reulated mannopine synthetase promoter"
1990 Plant Mol Biol 14, 433-43

> <>

= = = = = = =

> Biotech Activists (biotech_activists@iatp.org) Posted: 06/22/2000 By
> mritchie@iatp.org
> ============================================================
> Date: Thu, 22 Jun 2000 14:44:54 -0400
> From: "Dion Casey"
> Subject: EPA approves Monsanto's GE potato
> Harmonization Alert agriculture/food listserver.
> www.harmonizationalert.org

> [Federal Register: June 15, 2000 (Volume 65, Number 116)]
> [Notices]
> [Page 37516-37517]
> From the Federal Register Online via GPO Access [wais.access.gpo.gov]
> [DOCID:fr15jn00-21]
> [[Page 37516]]
> =======================================================================
> or 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 Plus line RBMT22-82
> (RBMT22-82), which has been genetically engineered for resistance to
> the Colorado potato beetle (CPB) and potato leaf roll virus (PLRV).
> Monsanto requested an extension of a determination of nonregulated
> status issued previously for NewLeaf Plus Russet Burbank
> potato lines RBMT21-129 and RBMT21-350, APHIS petition number 97-204-
> 01p (63 FR 69610-69611, December 17, 1998, Docket No. 97-094-2). Based
> on the similarity of RBMT22-82 to RBMT21-129, the antecedent organism,
> Monsanto requested a determination that CPB-and PLRV-resistant potato
> line RBMT22-82 does not present a plant pest risk and, therefore, is
> not a regulated article under APHIS' regulations in 7 CFR part 340.
> 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.
> [[Page 37517]]
> 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

~~~~~ Jill Davies ~~~ River Care ~~~~
To study the Way is to study the self.
To study the self is to forget the self
and to be enlightened by all things.