Aug 21, 2011
01 August 2011: 38 Agricultural organizations have signed a letter to Congressional Leaders urging them to allow the Food and Drug Administration (FDA) to complete its review of the world’s first genetically engineered fish for human consumption.
The move follows a recent amendment to the Agriculture Appropriations Bill (HR2112) that would stop the FDA from spending appropriated funds to finalize its review of the fish.
AquaBounty Technologies AquaAdvantage Atlantic salmon includes a gene from the faster growing Pacific Chinook salmon, which enables it to reach maturity twice as quickly as standard Atlantic salmon.
In the letter addressed to John Boehner, Nanci Pelosi, Harry Reid and Mitch Mc Connell, the authors call on Congress to reject the amendment, which was approved by voice on June 15th with only a handful of the House of Representatives in attendance.
Science-based review should not be subject to political intervention
Here it might be prudent to point out that 2 of the signatories are the American Meat Institute and the Biotechnology Industry Organization (BIO).
The letter states: “ Preventing regulators from completing their assessments will dent the credibility of the FDA’s science-based approval process”. The authors of this not so subtle letter go on to say: “ We do not write to support or oppose this specific application, but rather to register our concern with the House’s action, which, if allowed to become law, would disrupt the FDA’s congressional mandate to base its assessment of human, and animal drugs, devices, vaccines and process applications on the best available science”. Here it may be prudent to let the reader know that the rDNA used to genetically engineer the fish is to be reviewed by the FDA as a “New Animal Drug” or NAD! (More on this later)
The authors then go on to cite comments from Dr Calestous Juma of Harvard’s Kennedy School of Government, which were made at a recent hearing on agricultural biotechnology: “It is not this particular fish that is at stake. It is the principle behind the amendment and its wider ramifications. It sends the message to the rest of the world that that the science based regulatory oversight as embodied in the FDA review process is subject to political intervention”. (You don’t say! MOST definitely more on this later)
Politicians have to play the hand that they are dealt
The amendment to block the approval process was proposed by House Republican Don Young from Alaska who had concerns that the transgenic salmon could threaten wild salmon populations, a concern that has been denied by AquaBounty. Speaking in the House on June 15th Young said, “It is crucially important we understand that this should not be allowed, for the FDA to say, okay, a genetically raised salmon – I call it a Frankenstein fish, – should never be allowed in our markets”. He was backed by others who claimed the fish could have ”grave, unintended consequences on human health. Preliminary studies show that the compounds in genetically engineered salmon may be linked to cancer and severe drug allergies“. And yet another who said “Because genetically engineered salmon are more sexually aggressive and resistant to environmental toxins, their escape would pose a catastrophic threat to wild salmon populations”. (Clearly SOME in the House take the time to read their memo’s after all!)
Congressman Jack Kingston was the lone voice who urged the House to allow the FDA to make a science-based assessment, saying: “We’re constantly getting on the FDA to use more sound science, less politics, have more transparency, and it appears that that’s what they’re doing here. And they may come out against genetically modified salmon, but they are just looking at it right now to determine”. (Clearly this man hates salmon)
Needless to say the House passed the amendment, (albeit on the technicality of not spending appropriated funds) effectively stopping the FDA from conducting the revue. So, without actually opening the Genetically Modified Can of “Worms” (to catch the fish with!) they took the easier way out, the temporary fix, but thank you, the fish was effectively contained. For then, for now. (more on this later)
Jim Greenwood, chief executive of BIO warned that interfering with the regulatory process in this way would also set a dangerous precedent. “ Disrupting FDA’s science-based assessment process based on non-scientific political concerns would set a dangerous precedent in our country. It is critical that the scientific experts who work within the FDA be allowed to conduct comprehensive scientific approvals without political influence”.
Ronald Stotish, CEO of AquaBounty is clearly frustrated by what he terms” The intervention of politicians in the regulatory process” and goes on to accuse the senators of trying to derail the approval of his transgenic fish and of “willfully ignoring science-based research and spreading misinformed paranoia”. He rails on: “The data is out there, although it has been ignored by all of the opposing groups – the FDA has already concluded that there is no food safety or environmental risk. But a science based review is being threatened by political shenanigans”. (My goodness man, hold yourself together! Just a moment, did you just say that the FDA has “already concluded”…? Did you just use the word “science”, again? More on this later folks)
AquaBounty claims that the transgenic salmon are sterile, exclusively female and unable to breed even if they do escape into the wild.
Subsequently though, an insider source has admitted that up to 5% are NOT sterile…….
AquaBounty CEO Stotish uses the words “science-based” and “already” an awful lot for someone who has in excess of $150 million riding on an as yet UN-reviewed ( according to both AquaBounty AND the FDA) assessment of this frankly fishy smelling New Animal Drug, don’t you think?
And lastly, (before I talk about the actual data on the fishy application) there is this gem from the FDA, based on it’s analysis of the AquaBounty technology published last September: “The food from AquaVantage Salmon that is the subject of this application is as safe as food from conventional Atlantic Salmon….In addition, no effects on stocks of wild salmon are expected“. (Now HOW would they know this? Isn‘t this whole whine about the issue exactly because the FDA hasn‘t the means to take a closer look at this “ transgenicfrankenfishsalmoneelthing” !?)
Gasp! Clearly the FDA sees absolutely no problems with this fish, this concept or the new animal drug itself…..without having formally seen the paperwork! Based upon the “technology“, the FDA has clearly made up it’s collective “Scientific Mind” about this in advance of the “scientific approval process ” so lamented as being “obstructed” by lone voice in the House Jack Kingston!
Now: This assessment of a genetically engineered salmon is the FIRST ever evaluation of a GE animal and will set the precedent for future approvals of GE animals. The FDA should be most especially cognizant of the scientific quality of the data and the rigor of the analysis needed to do a proper safety assessment of GE animals in this case. (Clearly they are not!)
There is sloppy science, excruciatingly small sample sizes (only 6 fish per group for the allergenicity study), indeed the allergin test methodology was SO broad as to be statistically irrelevant, and so brief as to appear more of an afterthought than any part of an actual process, irrelevant or otherwise! Questionable practices of data manipulation (incomplete information/ conflicting information with regard to the IGF-1 data) and desperately inadequate analysis of conclusions of growth hormone levels in the flesh of the fish due to NO data at all on growth hormones due to the use of insensitive test methodology! And my personal favorite: the part of the study that dealt with phenotypic characterization data, along with all nutrient and food safety assessment data was based on the SIX fish at the PEI facility, NOT in the Panama facility, (as per the documentation) where they expect to raise these little genetic mutations. Indeed, even AquaBounty acknowledges in the report that the factors related to the two different locations on the “AquaVantage phenotype is unknown!” Therefore the FDA seems willing to conclude that there will be NO animal or human problems OR safety concerns with Aqua frankenfishsalmoneelthing raised in Panama, or in Canada where it is rumored they may set up shop too, down the road.
And this assessment on safety, (or lack thereof) by the FDA is based on….(?) NO DATA at all !!!! Unacceptable. The FDA MUST demand data on GE salmon produced under the SAME husbandry and rearing conditions as the salmon they expect to present to the public for consumption.
In no way possible at all does this analysis conform to the FDA standard for assessment of a New Animal Drug (NAD).
The FDA requires NAD’s to be shown to be safe for animals, humans and the environment. This has NOT been shown for the GE salmon. What HAS been shown despite the woefully incomplete data has raised legitimate concerns about the potential for serious human health issues, namely the increased risk of allergenic potency and the continued exposures of the general population to an additional hormone mimicking byproduct of this transgenicfrankenfishsalmoneelthing.
The study fell flat in other key areas too: there was nothing under the “General Health Observations” since there was no knowledge of the criteria used and therefore no way to assess the (lack of) findings this was a Fail.
Under the heading “Direct and Indirect Hormone Factor” the study failed here too along with this nonsense gem that we the people have heard a tad too many times in the last 20 years or so (Vioxx anyone? rBGH anyone?)…..here it is then: “ No biologically relevant differences were detected in the levels of gene product/salmon growth hormone,”……but again: this is based on sloppy science and data deprived data…insufficient evidence (empty boxes on forms) where there should have been a notation saying” SEE ATTACHED FOR COMPREHENSIVE DATA”…at the very least. The hormone study (by the way) was statistically irrelevant because:
2. The fish should have been tested at their market size, that is to say, at the size they would be when eaten!
Frankly, people just don’t EAT 2 ounce salmon!
FDA should have dismissed this study as irrelevant to the question of the direct food consumption risk, based on the guppy antics of the samples. This is the equivalent of testing a 6 year old girl for ovulation hormone activity as a marker against which to treat her mother….it is simply irrelevant and of no scientific value or consequence!
Further, the growth hormone is IGF and DOES pose a risk to humans, due in part to the raised levels of IGF and other growth hormones in ALL food producing animals. The interesting thing here is that the FDA itself (in this assessment) admits mush by noting, “ IGF levels are closely linked to growth hormones….may pose a hazard to humans…..has been considered a hazard for human consumption following increased growth hormone levels in in food producing animals (a reference to the issue of IGF-1 levels in milk from cows treated with a recombinant bovine growth hormone aka rbGH ) SO, fraudulent science meets….MORE fraudulent science!
Something else that we the people should be questioning on a deeper level at this time is this: If the stated reason for creating a genetically engineered salmon is to speed up the growing time of the salmon…..and if the gene splice is occurring with the Chinook BECAUSE of the Chinooks rapid growth cycle…….then WHY is it STILL necessary to add a GROWTH HORMONE to this creation? Doesn’t the one negate the necessity of the other, or vice versa….?
FDA should have dismissed this study the first chance they got (despite initial squeals from AquaBounty about “proprietary information and attempts to suppress the data)yes, can you believe that? And now CEO Stotish is criticizing the senators, NOT the FDA…….although officially of course FDA has not “had a chance to review the study” and AquaBounty has not had a chance to defend it’s “science-based” multi million dollar frankenfishsalmoneelthing. Clearly though an agreement has been reached, a compromise made, a deal struck. With or without spending from “appropriated funds” the FDA has made their feelings (and approval ) of AquaBountyfrankenfishsalmoneelthing quite clear, have they not?
Which brings me to something we should all be aware of: the primary reason why the FDA is proposing to approve the transgenic DNA for the salmon as a New Animal Drug, and not, let’s say as a “genetically engineered fish organism” is simple….
Once approved, a NAD will have NO POST Market Surveillance! As a product NOT required to be labeled (as a GMO product) the transgenicfrankenfishsalmoneelthing will simply disperse across America, into supermarkets, restaurants, fish (soup) stocks, pet food and (heaven forbid!) into Fish Oil supplements (omegas). (That is, until the proposed FDA ban on supplements takes hold and grows to include fish oils). But that is a different kettle of fish entirely!
AquaBounty/AquaVantage and 37 OTHER industry heavyweights want to accuse the congress/senate of holding the “scientists at FDA” back from doing their jobs of approving this? They want to accuse the senate/congress of holding Science hostage to politics? Over this irrelevant, fraudulent piece of quassi pseudo science?
Given that Monsanto heavyweight and legal representative Michael Taylor has revolved through the doors of the FDA and Monsanto so many times that even HE must have trouble remembering which building his current office is situated in (for now he is the FDA “ Food Czar, courtesy of our current president, in whose garden grows the most lavish un-permitted “ Victory garden”….would the Green Police really stop there? One has to wonder, but I digress…..)
Yes, given that Taylor is the current food czar, and given his moribund appetite for creating the pro biotech regulations (when working as legal council for Monsanto) that the industry would lobby for, and his subsequent implementation of those laws (once niftily ensconced on his “FDA throne”) (during one of many office changes) there is no doubt that he is salivating at the chance to approve the transgenicfrankenfishsalmoneelthing so revered by the Biotechnology Industry Organization (BOI) that they had to write a letter to the House full of warnings and undercurrents that, in some measure could, and should, be construed as a threat.
According to public interest attorney Steven Druker, who has studied the FDA’s internal files, “During Mr. Taylor’s tenure as Deputy Commissioner, references to the unintended negative effects of bioengineering were progressively deleted from drafts of the policy statements (over the protests of agency scientists) and a final statement was issued claiming that (a) GM foods are no riskier than others and (b) that the agency had no information to the contrary.”
When the FDA announced it’s original policy on GMO, the public was not aware of any internal dissent. The policy boldly claimed that there was no information to indicate that GM foods were different or more risky than natural varieties. Since the public generally trusted the FDA, they assumed that no such risks existed. But, nearly a decade later, a lawsuit would make public – for the first time – the agencies internal documents – and they told a very, very different story.
A man from a biotech company told author Michael Pollan, (that the biotech company)” should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job”.
That man was Phil Angell, Director of Corporate Communications for Monsanto.
AquaBounty/ AquVantage……Monsanto…….FDA…. All share one thing in common: Fraudulent Science.
© 2011 Dinah Everett Snyder
1. William Reed Business Media: Agro Groups: Derailing GM fish review would dent FDA’s credibility
2. Seeds of Deception: Jeffrey Smith
3. Union of Concerned Scientists: Admin Docket No.FDA-201034-N-0001
4. Science at Risk: Internal memos and documents of the FDA
5. Alliance for Bio Integrity: Steven Druker: Docket No 00N-1396
6. “ Pre Market Notice Concerning BioEngineered Foods” 66 Fed. Reg 4706 (January18, 2011)
About the author
Dinah Everett Snyder is currently writing a book about the FDA titled “CrimesAgainstHumanity: Is FDA the Rogue Militia for Big Medicine, Big Agriculture & Big Money….and WHY it matters!”
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