[PAA-Discuss] Fwd: Rosenberg - US Govt Hearings Go Swimmingly for GM Salmon

Tue Sep 28 00:08:50 EDT 2010

-----Original Message-----
From: Vince Boehm <vince_19805 at yahoo.com>
To: undisclosed-recipients:;
Sent: Mon, Sep 27, 2010 8:12 am
Subject: Rosenberg - US Govt Hearings Go Swimmingly for GM Salmon

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While this piece does not deal with our usual topics, it illustrates 
the absence of a firewall between industry and the FDA.  Martha 
Rosenberg is a talented writer, a friend, and a gifted editorial 
cartoonist who lives in the Chicago area.

Vince

http://www.scoop.co.nz/stories/print.html?path=HL1009/S00188/us-govt-hearings-go-swimmingly-for-gm-salmon.htm

US Govt Hearings Go Swimmingly for GM Salmon
Monday, 27 September 2010, 6:06 pm

by Martha Rosenberg

Rockville, MD - Even though the US Food and Drug Administration (FDA) 
held hearings about how AquAdvantage Salmon should be labeled the day 
after hearings about if it should be approved this week, it said it has 
not decided yet about the genetically engineered fish.
Unfortunately, its invited speakers didn't get the memo.
Presenting to the Veterinary Medicine Advisory Committee (VMAC) on 
Monday, Yonathan Zohar, from the Center of Marine Biotechnology at the 
University of Maryland, extolled the "promise" of aquaculture and 
bashed Greenpeace and other groups who are against growing "fish in 
cages."
And, Alison Van Eenennaam, with the Department of Animal Science at 
University of California-Davis, declared during labeling hearings on 
Tuesday, that GE salmon "poses no additional risk," criticized the New 
York Times' AquAdvantage Salmon coverage and laughed at peanut allergy 
labels. She also served on the veterinary committee advising the FDA, 
the previous day.
The AquAdvantage Salmon was created by inserting the coding sequence 
 from a chinook salmon growth hormone gene, under control of an ocean 
pout gene, into wild Atlantic salmon. The resulting fish grows twice as 
fast as wild Atlantic salmon, reaching its full size in 18 months 
instead of three years.
Though the fish, all female, are 95 to 99 percent sterile, Boston-based 
Aqua Bounty Technologies' (ABT), its developer, says eggs will be grown 
on Prince Edward Island in Canada and adults in Panama because the 
respective marine environments discourage survival of escapees.
The FDA has approved GE crops, genetically modified bovine growth 
hormone (BGH) used in milk and, last year, a goat with human genes to 
create a blood clotting drug. But the AquAdvantage Salmon is the first 
GE animal whose flesh will actually be eaten.
Because the AquAdvantage Salmon is affected by a "transformation event" 
and the injected DNA "imparts traits" to the animal, the salmon's 
application is actually being treated as a "new animal drug approval," 
hence a vet committee.
Some say the public health orientation of the new top two at FDA, 
Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein 
(who spoke Monday and Tuesday) will spell a harsher climate for 
genetically engineered foods. The public is also becoming less GE 
friendly and rejected BGH in milk in 2006, 13 years after it received 
FDA approval.
But FDA staffers who spoke at the hearings read right out of Aqua 
Bounty Technologies' playbook, creating distinctions between "risk," 
"hazard" and "harm" -- ice is only a risk if you slip on it they 
pointed out -- that made the fish appear safer. http://bit.ly/bEJZlr
FDA staffers also said the AquAdvantage Salmon had minimal impact on 
the "human environment" until the advisory committee asked as opposed 
to what other kind of environment whereupon the term was dropped.
FDA's Eric Silberhorn itemized ABT's redundant safety systems to 
prevent the escape of GE salmon -- screens, floor drains, chemical 
containment, chlorine, nets -- as written in the sponsor's 
Environmental Assessment, prepared for the FDA, bringing to mind BP.
Why does the government present industry data on behalf of industry, 
some in the audience asked, and why is industry called the "sponsor" 
instead of "applicant"?
AquAdvantage Salmon were also said to be less "fit" if they escape 
though no one quoted the part of ABT's Environmental Assessment report 
that says the salmon eat five times as much as wild salmon and have 
less fear of predators. (see: Jurassic Park)
The risk of bootleg AquAdvantage Salmon surfacing in unregulated Asian 
operations, even returning as imports like a "transgenic shrimp" 
Silberhorn says is reported in US food, would be handled with the 
labeling, control and inspection given any US drug, said staffers. Of 
course other nations, like Canada and Panama are "sovereign" and not 
bound by our laws, added FDA's Larisa Rudenko.
Frankenfish Fears
While the FDA did not use the loaded terms drift and mutate (or 
Frankenfish) it did request a "durability" report from ABT to make sure 
nothing genetically untoward happens.
And its Center for Veterinary Medicine briefing report finds an 
unexpected and unwanted genetic "rearrangement" with the AquAdvantage 
Salmon which relocates the inserted genetic material from "the far 
upstream promoter regions" to a "downstream location relative to the 
growth hormone coding region." Oops. The loss of part of a "35 base 
repeat region" and possible duplication of another effect were also 
reported. http://bit.ly/clF7D0
Asked by the committee if the genetic unknowns could create 
unanticipated events, Jeff Jones, a veterinarian presenter at the 
hearings, said the changes were "not subject to the hormone feedback 
system" in the fish and that the relocated genetic construct currently 
abuts "something that can't be read."
Elsewhere in its report, the FDA finds low glucose levels and high 
incidences of jaw erosion, focal inflammation and insulin-like growth 
factor 1 (IGF-1) in the AquAdvantage Salmon but concludes, giving no 
evidence, they are not caused by the genetic engineering.
While the FDA report says ABT's excessive culling of "abnormal" salmon 
may have "skewed" safety studies, it does not question ABT's proposed 
method of disposing of salmon affected by the 3Ms, mutations, morbidity 
and mortality.
"As dead fish are deposited, they will be covered with caustic lime, 
followed by another layer of dead fish and caustic lime, etc., until 
the burial pit is ~0.5 m deep, at which point it will sealed with 
plastic and covered with soil," says ABT's Environmental Assessment. 
"In the event that disposal capacity at the site is inadequate to 
handle the immediate or aggregate waste volume, alternative means of 
disposal will be sought."
Antibiotics, veterinary drugs and coded antibiotic resistance were 
barely mentioned at the hearings (though Zohar predicted egg farm like 
densities of up "80 to 100 per cubic meter for the GE salmon) -- nor 
was the practice of harvesting wild fish to feed farmed fish (though 
one invited speaker actually promoted the practice.)
In fact there was only one meltdown in the FDA's otherwise confident 
presentation and it concerned ABT's allergy study whose, "technical 
flaws... so limit its interpretation that we can not rely on its 
results," says the FDA report.
When FDA food scientists Kathleen Jones and Kevin Greenlees presented 
the allergy research, which sought to establish safety levels with no 
number that would be unsafe, the advisory committee pounced.
"It's as if you selected an allergen in goat meat and one in sheep meat 
and compare the two and found a difference," said Louisiana State 
University's David F. Senior, who chaired the committee. "Who cares?"
"These studies are a bust," said another committee member, asking why 
they were not conducted again.
"I am not a statistician and she is not here today," retreated Jones, 
adding that the studies were absolutely "above board," though no one 
had suggested they weren't.
"You've reached the limit of my statistical" knowledge said Larisa 
Rudenko.
And when James D. McKean with the Department of Veterinary Diagnostic 
and Production Animal Medicine at Iowa State University asked why a 
category of salmon suddenly was dropped from a table as a lone, extra 
salmon seemed to appear out of nowhere, FDA's Greenlees said, "It's my 
fault" and "I apologize."
Many hope an apology for considering an approval of the AquAdvantage 
Salmon itself is forthcoming.

Related Stories on Scoop

US Govt Report Finds Dangerous Residues in Meat 20/05/2010
Technician Causes Two Problems for Animal Research 05/10/2009
Resistant Microbes Disclosed at Science Meeting 02/03/2009
Marian Hobbs GM Speech 13/11/2001
GM Recommendations Must Go Through 29/10/2001

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