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[SANET-MG] pharming GM algae in Hawaii



GROWING BIOPHARMACEUTICAL ALGAE IN KAILUA-KONA PROPOSED

YOUR WRITTEN TESTIMONY IS NEEDED BY THE 26TH.
Hawaii Board of Agriculture Hearing June 28, 2005

THANKS TO OVER 70 WRITTEN TESTIMONIES received at the last hearing, THE FIRST PERMIT to allow the importation of biopharm algae genetically engineered with the Herpes Simplex virus antibody, WAS DENIED at a May 25, 2005 meeting of the BOA.

YOUR TESTIMONY IS AGAIN NEEDED regarding 8 STRAINS OF BIOPHARMACEUTICAL ALGAE. Mera and Rincon are seeking approval for the other seven strains, and possibly this one again at their meeting which will be held Tuesday June 28, in Kona. (time and location to be announced).

-According to Dr. R. Malcolm Brown, who has conducted research on algae for 40 years and has done much of the research that exists on algae on Hawaii Island says that native strains of Chlamydomonas reinhardtii (C. reinhardtii) exist in all soils, fresh, brackish and salt waters, and can dry up and hibernate and move into the air.

FOR BACKGROUND INFO SEE BELOW

____________________________________
e-MAIL YOUR TESTIMONY TO
hdoa.board.testimony@hawaii.gov
Please try to turn in your testimony by Sunday June 26.
Please add the word testimony and the subject matter on the subject line of the email.
_______________________________________

Please come and support the public's right to know and participate in the final decision. Testimony either oral or written is very meaningful to the board, as was witnessed by 80 of you who submitted testimony with only a few days notice.
mahalo for your concern on this very important matter.
We will inform you of the time and place of the board hearing as soon as we know.

_______________________________________________________________
_________________BACKGROUND___________________________________
“First, early studies of soil algae in the State of
Hawaii establish the presence of native Chlamydomonas on the island of Hawaii. Release of new genotypes poses a risk of hybridization with native species.”
-	Dr. Celia Smith, Professor of Botany at University of Hawaii

“This alga does indeed have the capability to form entities through its natural life cycle that can be carried away from the intended growth areas. I think for this reason alone, and because we do not have detailed information on the native Chlamydomonas species here in Hawaii, erring on the side of caution would be the prudent choice at the moment.” -Alison Sherwood Phycologist & Assistant Professor of Botany University of Hawaii

“This Chlamydomonas, while growing very well in an aqueous environment, also can grow and reproduce in soils, and living cells can be TRANSPORTED in the air! Either the zygotes, or more often, clumps of vegetative cells or even the gametes which dry out, are perfectly VIABLE and can be recovered.” -Dr. Malcom Brown has studied algae for 40 years and has done some of the primary work on algae on Hawaii Island.

			POTENTIAL FOR ESCAPE VERY REAL
“I read in the article in West Hawaii Today about the assurances by Mera that it will be safely grown in their enclosed growth modules. I helped to design and built those modules. In my 5 years of employment at Aquasearch my job as a lead technician and maintenance person involved me in helping design and build every aspect of the facility including the growth modules and the processing plant…In my opinion, there is no way for Mera to guarantee that they can grow anything there and it will absolutely not end up in the groundwater, out in the nearby shore or carried away by unknowing employees to who knows where…The growth module end sections are made of Schedule 40 PVCplastic. The polyethylene tubing that makes up the length is joined to the ends by means of foam tape as a seal and then the outer layer of the polyethylene tubing is wrapped with duct tape to keep it from tearing and then held on with stainless steel clamps. The system is sterilized after building with a sodium hydroch What is a bigger and more serious concern is that during thegrowing cycle, the module sits on the module pad semi submersed in a constant bath of cold sea water used for temperature control. When a module springs a leak (which is often enough as the tubing is only polyethylene and can be punctured by tiny lava rocks or any pointyobject) the only way it is known is if someone noticed the volume of the module is much lower or if they happen to spot the leak while tending to the module's shade cloth or whatever. In the meantime,gallons and gallons of culture have run into the drainage system which leads directly to an untreated hole in the ground not more than 100yards from the shore and is below sea level. Mera may tell you this is not really a problem because this same hole is used for the dumping of the sodium hydrochloride mixture used to sterilize all the systems. I seriously doubt there is always chlorine in that hole especially at night when there is no one there but the module may still be leaking. Another major concern is the harvesting and processing of the algae. When harvested, the culture is sent to a large holding tank where the algae is allowed to settle out. Most of the algae will sinkto the bottom and then the top water is drained off to reduce the volume to be centrifuged. This drained top water is once again sent to the big hole in the ground still full of live cells and more will join it as it is further processed. If the product is dried on site,even if it is ruptured first, the belt drier used can cause dried (and stillalive cells) to become airborne by it's exhaust which can be carried across the street to Cyanotech and contaminate their ponds growing algae for their products Spiralina or BioAstin. Aside from the methods mentions so far there is also the very real possibility that this algae will end up in the clothing and on the bodies of the employees and carried far off the premise. Washed cloths will then carry the algae into th -Mark Bilan, an past employee of Mera Pharmaceutical when it was known as Aquasearch Inc.

		     NEGATIVE HEALTH CONCERNS
“The petition failed to provide minimal information about the genetic
makeup of the strains to be introduced into Hawaii. On top of that the
fact that synthetic approximations of human genes was not mentioned. The claim that the risk of contacting the recombinant products was
negligible even in the worst case seems to have been groundless because
there were no experiments reported that support that conclusion.
For example, strain aFceR produces 1r-1 molecule targeting the IgE to
reduce inflammation. The petition did not provide evidence showing that
the protein was inactivated on ingestion nor did it discuss problematic
side effects. Strain TNFr-1 produces anti-tumour necrosis factor
antibody, as above there was no evidence that the protein was
inactivated on ingestion nor was there any discussion of the a potentialimmune response leading to anaphylaxis following repeated exposure.Strain TNr-1 produces IgG1d antimicrobial antibody, that antibody seems unlikely to be inactivated by ingestion and repeated exposure is likely to result in anaphylaxis. Strain aCRr-1 produces anti-cancer proliferation antibody, there was no evidence presented on the destruction of the antibody on ingestion nor of the problem of
anaphylaxis following repeated exposure. Strain aIL 10r-1produces
various interleukins (various including interleukin 10, interleukin 13.
interleukin 5 and interleukin 3). Interleukins are very potent
regulators of the immune system and they are active in minute
quantities. The petition failed to provide evidence that the
interleukins were destroyed on ingestion but pulmonary exposure to
interleukin 13 , for example, causes inflammation, mucus hypersecretion
, physiologic abnormalities associated with asthma (6). Interleukin 10
is a powerful immune suppressant (7).The many adverse effects of the
interleukins should have been discussed in the application but were not.Strain aARTr-1 produced unspecified neurotrophic factors to stimulate growth of nerve tissue. Since the factors were ill defined it is not possible to evaluate any effects of the nerve factors or their stability.”
               -Professor Joe Cummins
________________________________________________
MAIL YOUR TESTIMONY TO
hdoa.board.testimony@hawaii.gov
Please try to turn in your testimony by Sunday June 26.
Please add the word testimony and the subject matter on the subject line of the email.
__________________________________________

PUBLIC MEETING June 24, 2005
Rincon & Mera Pharmeceuticals will be holding a public informational presentation on Friday June 24 at 6:00 pm at NELHA in the main conference room. They are seeking permits to import to Kona the algae Chlamydomonas reinhardtii that has been genetically engineered with eight separate different human monoclonal antibodies. The purpose would be to create pharmaceuticals cheaply and easily. Also, this 4 acre NELHA facility was never meant to produce drugs, and there are many ways they will escape. We need to exercise caution and ask all the necessary questions. Please. show up, and be the faces and voices of Kona.



Minor Corrections to a previous version of the above that was sent to some of you:

>> Malcolm Brown has not studied algae in Hawaii for 40
>> years,but he has done much of the early research that
>> still stands today on airborne and soilborne algae of
>> Hawaii island.  He had been studying algae in many
>> locations for 40 years.  He currently is the Johnson &
>> Johnson Centennial Chair of Molecular Genetics and
>> Microbiology at the University of Texas at Austin

____________________________________________________
MAIL YOUR TESTIMONY TO
hdoa.board.testimony@hawaii.gov
Please try to turn in your testimony by Sunday June 26.
Please add the word testimony and the subject matter on the subject line of the email.
____________________________________________
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