Anyone run across the "guideline" book that tells reseachers the lines they mustn't cross? Or is it the registration level that we rely on to protect us from allowing anything that can be done; to be done. Also where do we find the policy and regulation book that those "bureocrats" live by?
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"Guidelines " for manipulation of Moter Nature
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Here is the European equivalent to the above.
[URL="http://europa.eu/legislation_summaries/agriculture/food/l21154_en.htm"]EU[/URL]
Would take some looking but likely could find the same things for the US (world biggest user of
GE technology) and Australia (very quickly moving into biotech).
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I followed the link to the |CFIA website and now know we are talking about plants with novel traits (PNT) . In the guidelines there are a lot of "not recommended"; "are encouraged" and "as possible"'s.
I didn't see any mention of required warnings to moose, elk or deer, or other wildlife; at least not until after the project is harvested and the residual plant material disposed of.
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."
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".
In all probability this can be taken literally and refers to an actual 6 test locations of field trials involvig Triffid flax. Anyone know where they were? Is there any correlation of contamination levels focusing around these sites?. At least provide the information to confirm that such risks are not certain problem causers.
Are the applicant/Canadian agents still around to take any responsibility for problems that might crop up?
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oneoff,
You asked for the current guidelines. The decision to release Triffid was made im May of 1996 under an earlier set of guidelines than those found in the link I provided. The 'example' cited in the directive to which I referred you to does not reflect reality to my knowledge (as with much federal government work).
The link to the actual decision document allowing for unconfined release of Triffid is:
http://www.inspection.gc.ca/english/plaveg/bio/dd/dd9824e.shtml
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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.
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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.
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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.
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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)
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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.
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