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bureaucratic quicksand



I have repeatedly tried to obtain useful information on commercial
hirudin in canola production in western Canada from cfia. Hirudin is an
anticoagulant drug that can cause internal bleeding. The food inspection
agency, a minor sub department of agriculture Canada has not been
forthcoming. The Canadian government bureaucracy seems to have complete
cooperation or control of the Toronto news media so that there is little
public awareness of biopharmaceutical crop testing and production in
Canada. The bureaucrats seem to have , again. slammed the door of
secrecy on such production. The letters below show the bureaucracy games
that are played.
Dear Prof. Cummins:

As I indicated in my previous message, Dr. Stephen Yarrow at the Canadian
Food Inspection Agency would be the best person to provide you with answers
to your questions.

best regards,

William Yan, Ph.D.
A/Director, Bureau of Microbial Hazards
Food Directorate
Health Canada





jcummins <jcummins@uwo.ca> on 2003-01-15 05:26:22 PM

To:    William Yan <William_Yan@hc-sc.gc.ca>, syarrow@inspection.gc.ca
cc:

Subject:    Re: hirudin production in canola


Thank you for the useful comment. Can you point me towards the decision
  document on those field trials are are they CBI The claim that hirudin
was being commercially produced is referenced as follows:
Transgenic plants as factories for biopharmaceuticals

  Glynis Giddings, Gordon Allison, Douglas Brooks, Adrian Carter
SUMMARY: Plants have considerable potential for the production of

biopharmaceutical proteins and peptides because they are easily

transformed and provide a cheap source of protein....
Nature Biotechnology18, 1151 - 1155 (01 Nov 2000) Research


"This method of purification ensures that hirudin in the plants only

becomes active after harvesting, thus limiting environmental exposure.

Oilseed rape transgenic for hirudin is now grown commercially in Canada

by SemBioSys (Calgary, Canada)"20.Boothe, J.G., Parmenter, D.L. &

Saponja J.A. Molecular farming in plants: oilseeds as vehicles for the

production of pharmaceutical proteins. Drug Develop. Res. 42, 172-181

(1997).
Along with these comments farm newspapers reported that Kamloops, BC was
the area chosen for the commercial production.
Any clarification you can give me on these conflicting reports and on
the field trials  would be appreciated.
Sincerely, Prof. Joe Cummins


William Yan wrote:

> Dear Prof. Cummins:
>
> Thank your for your message below regarding hirudin in canola.  I am

happy

> to provide you with the following information:
>
> Canola expressing hirudin has been permitted for small-scale confined
> research trials in Canada but has not been approved for unconfined
> release/commercialization. The Canadian Food Inspection Agency's Plant
> Biosafety Office regulates environmental releases of plants with novel
> traits, including plant molecular farming. Health Canada would be
> responsible for regulating any product derived from these plants under

the

> Food and Drugs Act and Regulations (foods, drugs, cosmetics, medical
> devices).
>
> For further information, please contact Dr. Stephen Yarrow, Director,

Plant

> Biosafety Office, Plant Health and Production Division, Canadian Food
> Inspection Agency (syarrow@inspection.gc.ca).
>
> best regards,
>
> William Yan, Ph.D.
> A/Director, Bureau of Microbial Hazards
> Food Directorate
> Health Canada
>
>
>
>
>
> jcummins <jcummins@uwo.ca> on 2003-01-15 10:04:31 AM
>
> To:    William_Yan@hc-sc.gc.ca
> cc:
>
> Subject:    hirudin production in canola
>
>
> Hello Dr. Yan,
> Several reports in the scientific literature refer to the commercial
> production of the anticoagulant drug , hirudin, in canola oil bodies in
> western canada. I have searched the Health Canada web site for the
> decision documents on the commercial production of the biopharmaceutical
> drug. I would appreciate your help in locating any pertinent documents
> on biopharmaceutical production of hirudin. Sincerely, Prof. Joe Cummins
>
>
>
>
>
>

.