"Guidelines " for manipulation of Moter Nature

[cpallett]

oneoff,

under Directive 94-08 which was in place when Triffide was approved, there is a requirement for a 'stewardship plan', but no indication anywhere that I can see that the developers "are reponsible for all cost(s) of all remedial actions". The link to Directive 94-08 is:

http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9408e.shtml

If it was that easy it wouldn't be as much fun to do what I do.

[oneoff]

http://www.inspection.gc.ca/english/plaveg/bio/dd/dd9824e.shtml. Repeat of cpallet's link and excerpts that I found interesting and informative.

Beginning of quotes


This Decision Document has been prepared to explain the regulatory decision reached under the guidelines Dir94-08 Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits and its companion document Dir94-10 The Biology of Linum usitatissimum L. (Flax), and the guidelines Dir95-03 Guidelines for the Assessment of Livestock Feed from Plants with Novel Traits.


Flax is predominantly a self-pollinating species, with a rate of natural outcrossing ranging from 0 to 5%, and this species possess does not possess any mechanism for wind or insect pollination. Thus gene flow to other L. usitatissimum is expected to occur at low frequency, if at all.





B3. The Reproductive Biology of L. usitatissimum
Cultivated flax is an annual reproducing by means of seed. Because of its flower structure and because its "sticky pollen" is rarely transferred by insects (Beard and Comstock, 1980), flax is a highly self-pollinated species. The pollen is viable for only a few hours, from the time of anther dehiscence until about the time the petals dehisce - between 4 and 7 hours (Lay and Dybing, 1989; Dillman, 1938). As the flower opens, the anthers come together and form a cap over the stigma. Dillman (1938) in studying natural crossing in flax reported the range of natural crossing from 0-5%, there being variation among genotypes. In over 8,000 observations in the flax variety "Bison" no natural crossing was observed.



Substantial equivalence is used in the comparative assessment of a PNT relative to its counterpart to assess its relative and acceptable risk:

i) A PNT that is substantially equivalent, in terms of its specific use and safety for the environment, as well as for human and animal health, to plants currently cultivated in Canada, having regards to its potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity, should pose no greater risk to the Canadian environment compared with its counterpart. A plant that is substantially equivalent to its counterpart and is derived from seed authorized for unconfined release may be exempted from the notification and authorization requirements under the Seeds Regulations.

ii) A PNT that is not substantially equivalent, in terms of its specific use and safety for the environment as well as for human and animal health, to plants currently cultivated in Canada, having regards to their potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity, may be authorized for release into the Canadian environment with appropriate environmental risk management and risk mitigation measures.

Before a PNT can be released into the environment, a determination of the associated risk to the environment, including to human health, is required.

The PBO is responsible for the authorization of release, whether it is confined or unconfined, of PNTs into the Canadian environment. The confined release, which may be considered to be a release for research purposes, involves imposing conditions such as reproductive isolation as well as restrictions on the use of harvested material and the field plot in subsequent growing seasons. Information relevant for the purpose of submitting an application for an authorization of confined research field trials is detailed in Directive 2000-07 (Dir2000-07), entitled "Directive for the Environmental Release of Plants with Novel Traits Within Confined Research Field Trials in Canada."

An unconfined release involves the release of a PNT into the environment with no restrictions, with a view towards commercialization. In general, a PNT will proceed from the research stage in a laboratory, growth chamber or greenhouse, to a confined field trial-based environmental release, and finally, to an unconfined release. Information gathered over several years regarding the agronomic/silvicultural and environmental characteristics of the PNT during its confined release stage will generally contribute to a developer's determination as to whether or not to proceed to the next stage of development, which is the unconfined environmental release. Particular PNTs, such as those intended for the production of pharmaceutical or industrial compounds, may be required to grow under conditions that provide for physical and reproductive confinement, even during its commercialization.

End of quotes


DIRECTIVE 94-08 contains these exerpts

7.4 Detection and Identification Requirements

Along with all other data, relevant to the environmental safety assessment of a PNT, the following should also be submitted to the CFIA:

•appropriate test methodologies for the detection and identification of PNTs;
•written agreement to provide the CFIA with reference material suitable to support these methods.




7.6 Post-release Monitoring Plan

A general post-release monitoring plan to monitor for unintended or unexpected environmental effects of an authorized product should also be an integral part of a complete application and will be reviewed during the environmental safety assessment of the novel plant in question. The use of appropriate indicators to evaluate these effects should be based on the characteristics of the PNT. A stewardship plan (Please see Section 7.5) may be considered acceptable for post-release monitoring purposes.

The applicant must inform the PBO of any new information regarding the risks to the environment or to human health resulting from worker exposure to the PNT that could result from the unconfined release of the PNT (Please see Section 9 for further details).



6. Environmental Safety Assessment of Plants with Novel Traits
6.1 Environmental Safety Assessment Criteria

•The PBO assesses the environmental safety of PNTs based on the five criteria:
•potential of the PNT to become a weed of agriculture or be invasive of natural habitats,
•potential for gene-flow to wild relatives whose hybrid offspring may become more weedy or more invasive,
•potential for the PNT to become a plant pest,
•potential impact of the PNT or its gene products on non-target species, including humans,
•potential impact on biodiversity

end of quotes. On Initial reading; it appears to me that there is no provision for consideration to bemade to anything outside human and animal health safety; weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity, should pose no greater risk to the Canadian environment compared with its counterpart. A plant that is substantially equivalent to its counterpart and is derived from seed authorized for unconfined release may be exempted from the notification and authorization requirements under the Seeds Regulations.
o
It was ammended in 2004; and I assume this linked document incorporates those changes. Triffid would have been approved at an earlier date. Would there have been any significant changes in the documents between revisions? Anyone care to again spoonfeed us? I've never had so much fun since a Biochemistry class over 40 years ago. It was addictive; how all those biochemical pathways actually tied together. In those days it was possible to actually feel confident at exam time that it all made complete sense. With the explosion of Biochemical knowledge since then it looks simply overwhelming.

[oneoff]

Previous post..... The second last paragraph should be totally deleted. It is just remnants of preparation drawn from several sources; all under the stress of losing everything when switching back and forth between sources.

I'll lay some of the blame on this agri-ville's forum design. A preview page, editing capability and spell checker would be all welcomed.

[oneoff]

cpallett I should read your complete answers before jumping in and following the links. Independently I noticed the "stewardship plan" you referred too. That is interesting and I'll dig on my own. Here's a search done on the CFIA site. I sure hated to see the name of the University of Sask as applicant/Canadian agent. In this case I believe they did immense damage to agriculture. A few more disasters like that and we might arguable be better off without such institutions.

•Product / crop type - Flax
•Original applicant - University of Saskatchewan
•Novel trait - Herbicide tolerance
•Designation Name - all
Flax
Product / Designation Flax FP967 (CDC Triffid)
OECD Unique Identifier3 CDC-FL001-2
LMO Status4 LMO
Applicant at time of application University of Saskatchewan
Novel Trait(s) Sulfonylurea tolerance
CFIA5 Approval for unconfined release into the environment6,7 Yes (May 8, 1996)
DD98-24
Approval for use as a livestock feed7,8 Yes (May 8, 1996)
DD98-24
Variety Registration9 No longer registered
Health Canada - Food Safety Approval5, 10 Yes (February 16, 1998)

[oneoff]

cpallet It's been a long day following links and I note you can't find any reference to my quotes from CFIA documents regarding "are responsible for all cost(s) of all remedial actions":
Under field trials there is the example
"c.Flax modified to be resistant to a specific herbicide as a result of one specific gene insertion, to be tested for agronomic performance in confined research field trials at six locations will be considered as six field trials."
I commented that The experiments require an applicant/Canadian agent to make the submission and makes them responsible for abiding by the rules for the field test; and that they "are reponsible for all cost(s) of all remedial actions".
Now I can't find that CFIA document either. It was under field trials; and I "cut and pasted" the quotes; so trust me that I didn't make it up.

Hint to lawyer: Find paragraph c. regarding the Triffid field trial example info; and you will be very close to the applicant/Canadian agent reponsibilities regarding any costs associated with field trial unconfined releases. I'll continue to look; but its almost like it disappeared.

[cottonpicken]

Did any one follow the link that europeans are not fond of gmos and seeing as flax goes to europe maybe common sence could prevail

[cottonpicken]

And did anyone follow the link that huge huge quanties will be sold in the future(just trust me on this)

And did anyone follow the link that this is the perfect moment in time for industry two strike and take our seed rights away fom us?

[oneoff]

cpallett It is there under http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007e.shtml Right near the end of the quote is the statement
"Where a confined research field trial must be terminated, the applicant/Canadian Agent is responsible for the cost(s) of disposal of the PNT. Further more, the applicant/Canadian Agent is also responsible for the cost(s) of all remedial actions required in the event of an accidental release of the PNT.

The applicant/Canadian agent is defined at the beginning
PS Please note the similarities between the Chief Justices concise summary on liability (and even examples used of pertinent cases); and the Triffid incident along with CFIA guidelines and examples they give below. Coming from a lawyer; I would appreciate a "free" opinion about how "but for " ties into this soap story. No invoices need be exchanged. PS As you notice; the CFIA statements are directed to confined releases in a field trial context; BUT FOR this step Triffid would not have gotten loose. The rest is history. Thanks

. Definitions
Applicant: The applicant must be a permanent resident of Canada or must designate a Canadian agent who is a permanent resident of Canada. The applicant does not have to be the breeder or owner of the PNT, however, if the applicant is not the breeder/owner, a signed statement is required from the breeder/owner authorizing representation by the applicant or the designated Canadian Agent. All correspondence with respect to the application, including authorization of trials, will be addressed to the applicant, or when appropriate, the Canadian Agent. The applicant/Canadian Agent must accept full responsibility for compliance with all terms and conditions of authorization.

Application: An application is the data package submitted for each modified plant species intended for a confined release and which meets the information requirements of this Directive. More than one submission may be included in a single application.

Confined research field trials: A confined research field trial is the release of a PNT, for research purposes, under terms and conditions of confinement designed to minimize any the exposure of the PNT to the environment. These terms and conditions include, but are not limited to, reproductive isolation, site monitoring, and post-harvest land use restrictions.

Construct: An engineered DNA fragment (e.g. plasmid) which contains, but is not limited to, the DNA sequences to be integrated into a target plant's genome.

Field trial: A field trial is an experimental trial of one submission, grown at one trial site location for the purpose of conducting research.

For example:

a.Two different lines of a plant species, such as canola (Brassica napus), one showing tolerance to the herbicide sulfonylurea, resulting from the insertion of the gene coding for an altered acetolactate (ALS) enzyme, and the other showing tolerance to certain insects by the insertion of the d-endotoxin gene from Bacillus thuringiensis, both to be grown in the same field trial site location in one year will be considered as two field trials.
b.Two different lines of tobacco, both showing tolerance to the herbicide sulfonylurea, resulting from the insertion of two different genetic constructs, both to be tested in a confined research field trial site location in one year will be considered as two field trials. A separate assessment will be carried out on each of the two different genetic constructs.
c.Flax modified to be resistant to a specific herbicide as a result of one specific gene insertion, to be tested for agronomic performance in confined research field trials at six locations will be considered as six field trials.
d.The same modified soybean to be tested at the same six general locations over two growing seasons will constitute 12 field trials
e.Perennial crop such as alfalfa, tested at one site over a period of several years, will be counted as one trial for each year it is tested.
Gene flow: The transfer of genetic material through interbreeding between sexually compatible plants.

Plant molecular farming: The use of plants in agriculture for the production of pharmaceutical or industrial compounds and not intended for general use as food and/or feed.

Plant with novel traits (PNT): is a plant that contains a trait which is both new to the Canadian environment and has the potential to affect the specific use and safety of the plant with respect to the environment and human health. These traits can be introduced using biotechnology, mutagenesis, or conventional breeding techniques and have some potential to impact weediness, gene flow, plant pest potential, non-target organisms, or biodiversity

Secure Container: Any means by which seed and any other propagable plant material may be contained for transport and storage such that a spill and/or dissemination cannot occur. The container must be labelled.

Seed: A "seed" as stated in the Seeds Act is defined as follows: Any plant part of any species belonging to the plant kingdom, represented, sold or used to grow a plant (Seeds Act).

Submission: A submission refers to each plant species/genetic modification combination. For example, two lines of the same plant species transformed with different constructs constitute two submissions. Two lines of the same plant species transformed with the same construct will constitute one submission, provided the two lines express the traits encoded by the construct in a similar fashion.

Trait(s): The phenotypic characteristic(s) conferred to the recipient plant by specific genetic changes.

Trial site location: A field trial or trials of a submission or submissions of a single species at a single location. Single location is defined as a single, unbroken geographical location.

Unconfined release: A release into an environment of a plant with novel trait(s) that is not isolated either reproductively or physically from managed or natural environments, but may be subject to other restrictions.

2 APPLICATION PROCESS FOR CONFINED RESEARCH FIELD TRIALS OF PNTs
The information requirements for the confined research field trials are described on the confined research field trial application form presented in Appendix 1. Application form must be completed in full to ensure timely evaluation and to minimize request for further information (must be provided in one of Canada’s two official languages; French or English). Application form for new confined research field trials and renewals of previously authorized confined research field trials of PNTs are required and must be submitted to the PBO for review in order to receive authorization for planting.

The applicant engaged in a confined research field trial must be a permanent resident of Canada or must designate a Canadian agent who is a permanent resident of Canada. The applicant/Canadian Agent must accept full responsibility for compliance with all terms and conditions of authorizations. Where a confined research field trial must be terminated, the applicant/Canadian Agent is responsible for the cost(s) of disposal of the PNT. Further more, the applicant/Canadian Agent is also responsible for the cost(s) of all remedial actions required in the event of an accidental release of the PNT.






NUFF SAID

[cpallett]

oneoff,

One clear problem is the quotation you provided: "Where a confined research field trial must be terminated, the applicant/Canadian Agent is responsible for the cost(s) of disposal of the PNT. Further more, the applicant/Canadian Agent is also responsible for the cost(s) of all remedial actions required in the event of an accidental release of the PNT."

The Directive (Dir2000-07) this quotation comes from was not in force when Triffid was approved in May of 1996. I doubt it can be taken to be retroactive in force and effect.

Another problem you have correctly identified is that suing the University of Saskatchewan is sort of like suing your mother. Bad optics.

On the other hand, suing the CFIA is what I do best. Clearly, if the CFIA had considered that which they ought to have considered in 1996 (gene flow or genetic drift), it is highly unlikely Triffid would have ever made it to field trials and certainly not into 'unconfined release'.

No real causation problem there. Massive duty of care problems (proximity and policy issues - my wheelhouse), but not causation.

The good news is that the Krebs Cycle is still alive and well.

[charliep]

I should stay away from this because I don't know what happened and
second not a lawyer.

My understanding though is triffid had passed through the research stage
under the CFIA rules you site, had been approved as being safe within
Canada and was in the multiplication stage from breeder seed to foundation
seed and finally certified seed with it available to all farmers in Western
Canada at the next stage. There may still may be liability but there are many
other sources of contamination at the different stages of the multiplication
process. I assume through evidence would have to established at what point
the triffid gene entered the system.

It should be noted it was an industry decision to have the triffid variety
pulled - not a CFIA one. Someone can correct me.