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COMMISSION FAILS ITS MISSION

HOW THE REPORT OF THE ROYAL COMMISSION ON GENETIC MODIFICATION
PRESENTS A FALSE AND UNJUSTIFIABLY FAVORABLE PICTURE OF
BIOENGINEERED FOODS

Steven M. Druker
Executive Director
Alliance for Bio-Integrity

www.biointegrity.org

New Zealand’s Royal Commission on Genetic Modification was supposed to carefully examine the competing claims about the various aspects of bioengineering and clarify the facts in a balanced and fair manner.  Unfortunately, it significantly failed to do so.  The report issued in July 2001 is to a substantial degree inaccurate and imbalanced, giving undue weight to questionable claims that cast genetic engineering in a favorable light while unjustifiably discounting and even ignoring sound evidence that implies problems.  Further, in many instances the commission members accepted false and misleading statements from biotech proponents as fact and presented them as such.  In several cases, their report itself makes major false assertions that unfairly buttress bioengineering.   

The report’s tendency to skew the presentation in favor of bioengineering even at the expense of factual accuracy is readily apparent in its discussion of genetically engineered (GE) foods and consumer safety.*  The following paragraphs examine the numerous errors the commission made while discussing this critical issue.  Considering the extent and the severity of these errors, it is reasonable to regard their report as substantially unreliable – and to reject the commission’s conclusions and adopt a more precautionary approach based on a proper understanding of the facts.  

The Report’s discussion of the toxic tryptophan calamity contains many statements that are clearly false and several that are seriously misleading.  

The Royal Commission’s (RC’s) discussion of the L-Tryptophan catastrophe of 1989 is deeply flawed.  This is of critical importance because in that incident a food supplement produced through genetic engineering was clearly linked with widespread death and disease.  The RC report to a large extent absolves the genetic engineering process of having caused the problems, but it does so by disregarding several key facts and by substantially distorting others, even to the point of making false assertions.   

The following background facts are undisputed.  For many years, supplements of the amino acid L-tryptophan were produced through a fermentation process that employed tryptophan-producing bacteria.  In the final phase of this process, the contents of the fermentation tank are passed through several levels of filtration to obtain a pure batch of tryptophan.  In order to increase tryptophan yield, the Japanese manufacturer Showa Denko K.K. decided to alter the DNA of the bacteria by splicing a new genetic construct into it.  In 1989, Showa Denko began sales in the U.S. of a particular tryptophan supplement produced through genetic engineering.  Within a few months of entering the market, this GE-derived supplement caused an epidemic of an unusual malady (called EMS) that eventually resulted in dozens of deaths and thousands of permanent disabilities.  

While the RC report essentially conveys the above facts, it fails to mention several other important facts – facts that had been clearly presented to the commission.  For one thing, it neglects to divulge that for many preceding years, the conventional L-tryptophan supplements of other manufacturers had been widely marketed and that epidemiological evidence from the Center for Disease Control does not link any tryptophan from these other manufacturers with outbreaks of EMS.[i]  Further, although the report acknowledges that Showa Denko’s GE-derived tryptophan was found to contain several toxic contaminants, it fails to note that at least one of these was highly unusual and had never been seen in any conventionally produced batches.  This is important, since it is well known that genetic engineering can alter cellular function so as to induce production of novel toxins.        

Moreover, not only does the commission’s report exclude facts that suggest the GE-derived supplement was uniquely problematic, it makes several false statements that tend either to downplay the problems or to imply that genetic engineering did not cause them.  For instance, it asserts that all the toxic tryptophan came “from a single Showa Denko KK batch,” which implies the problem was a rare quirk that was not associated with the GE production process in any ongoing way.  In fact, the toxic supplements came from numerous batches produced over a span of at least nine months, and possibly several years. Further, the report appears to err in stating that nonhazardous GE-derived tryptophan was on the market along with Showa Denko’s toxic product.  It says: “At the time, several companies, including Showa Denko KK, used vat fermenters and genetically modified bacteria to produce tryptophan.”[ii]  Later on the same page, the report says that the lack of problems with these other GE tryptophan supplements suggests that GE was not the cause of the extensive deaths and cripplings: “At the time, other tryptophan products made using genetically modified organisms were available on the market, but no problems were reported with them, suggesting that the use of genetically modified organisms alone was not to blame.” 

According to investigative journalist William Crist, who has spent years researching the tryptophan incident, there is no evidence that any manufacturer other than Showa Denko used genetic engineering to produce tryptophan food supplements during the 1980’s.  John Baker, a plaintiffs’ attorney who was on the National Steering Committee for the various U.S. lawsuits against Showa Denko, told Mr. Crist that as far as he knows, only Showa Denko was using recombinant DNA technology to produce tryptophan during this time.  Further, I have spoken by phone with Don Morgan, an attorney in the Washington, D.C. office of Cleary, Gottlieb, Steen and Hamilton, which serves as worldwide counsel for Showa Denko and represented it in all the U.S. lawsuits.  Mr. Morgan said he remembers hearing or reading that another tryptophan manufacturer might have tried genetic engineering at some point but that neither he nor his colleagues ever received solid confirmation of this.  He also said that even if another manufacturer had experimented with bioengineering, as far as he knows there is no evidence that any of its GE-derived product ever came to market.  Mr. Morgan's impression is fully in accord with the published record, which nowhere suggests that any manufacturer other than Showa Denko used GE to produce tryptophan. 

Because the commission linked its assertion that harmless GE-derived tryptophan was marketed during the 80’s to an implication that the GE process was therefore not the cause of the epidemic, it should have been sure of its facts and clearly substantiated its claim.  However, it has failed to provide the requisite information.  The RC report gives no specific reference for any assertion it makes about the tryptophan incident.  Rather, it lists all its sources for the entire tryptophan section in one large reference note.  These sources comprise numerous submissions to the commission by interested persons and many journal articles.  But no page numbers are provided, nor is any source specifically linked with any assertion, making it extremely difficult to discover from which source each assertion was derived and to check the accuracy of the report’s wording.  In effect, this bars meaningful review of the assertions and their references, for to do so, one must read completely through twenty substantial documents trying to find statements that serve as back up for specific statements in the report, never sure whether one’s surmise about the match is actually the reference intended by the commission.  Such an unorthodox and onerous system of referencing clearly contravenes the commission’s own consistent call for openness, transparency and accessibility. 

Considering that the report makes numerous false statements in discussing the tryptophan incident as well as many other issues (as the following paragraphs demonstrate) and the fact that several knowledgeable people are unaware of evidence that any manufacturer besides Showa Denko marketed GE-produced tryptophan, the completely unsubstantiated claim that other manufacturers did so is highly dubious.  Unless and until the commission can produce solid evidence that validates this claim, it is justifiable to regard it as false.   

Returning to what the report says, it makes another false statement that even more strongly implies genetic engineering’s innocence than does its claim about the presence of harmless GE-derived tryptophan in the 80’s.  It asserts: “The United States courts decided that the manufacturing process rather than genetic modification was at fault.”[iii]  In my conversation with Mr. Morgan, who was directly involved in Showa Denko’s legal defense, I learned that over 2,000 of the lawsuits were settled out of court and that only three went to trial.  Mr. Morgan stated that due to the nature of product liability law, the basic issue in these cases was whether Showa Denko’s product had caused harm.  He said the issue about whether the genetic engineering process played a role in causing the harm was not relevant and was never raised – and that none of the jury verdicts in any way touched on it.  He seemed surprised that the Royal Commission would assert that the U.S. courts had decided the issue.     

It is difficult to understand how the commission made such a blunder, especially since it should have been aware its allegation was dubious.  First, the wording is self-contradictory.  The commission asserts the courts “decided that the manufacturing process rather than genetic modification was at fault.”[iv]  However, the genetic modification is clearly part of the manufacturing process.  Therefore, even if the issue of the role of bioengineering had been relevant in court, it’s almost inconceivable that any such ruling would have actually issued, since it would have been nonsensical.  Second, anyone with a basic understanding of product liability law should have thought it odd that juries would be attempting to determine the role of genetic engineering in the causation of EMS.  It is surprising the commission made such an obvious error in alleging what is supposed to have happened in legal proceedings, especially since its chairman is an experienced lawyer who served for many years as a judge. 

Although not as substantively critical as the preceding misstatements, the report did make yet another false assertion in reporting that out of the six EMS-related toxins found in the GE-derived tryptophan, three were not accurately identified until 1999.  In fact, two of these were identified in 1998, while one remained unidentified until 2000.[v]  This is further indication of how lax the commission’s fact-finding process was – and how long it can take to identify novel toxic substances even after they have killed people (in this case, up to eleven years).  

Further, the report implies that the only people who got EMS were taking “high doses.”  In fact, people taking relatively low doses, even as low as 100 mg, also contracted EMS.  While the report does not explicitly state that the tryptophan was harmless at medium and low doses, its presentation gives that impression. 

When the report incorrectly and carelessly states that the courts decided “that the manufacturing process rather than genetic modification was at fault,” it is apparently trying to say that an aspect of the process other than GE was found to be the cause.  In other sentences, the RC more clearly indicates that the filtration procedure is suspect.  During production of the fatal batches of tryptophan, Showa Denko had reduced the amount of charcoal used in filtration.  The report states: “It is unclear whether the high concentration of tryptophan made by the genetically modified bacteria or the changes in the filtering system were responsible for the build up of contaminants.”[vi]  

By presenting the issue of causation as a simple either/or situation, the commission displays a serious lack of understanding – and misleads the reader.  In its rendering, the contamination was caused either by increasing the level of tryptophan production through bioengineering or by the change in filtration.  However, while it is reasonable to suspect that the change in filtration played some role in the contamination, it is clearly unreasonable to imply that it could have played the exclusive role.  To attribute the problem solely to the filtering system is like saying that a soldier’s death was caused by a defective helmet while saying nothing about the bullet that pierced his helmet and then shattered his skull.  If the reduction of charcoal allowed toxins to contaminate the final product, it was only because toxins had been produced.  Accordingly, the key question should be: “Were some of these toxins unusual and unusually problematic?”  If toxins arose that are not normally associated with the conventional production of tryptophan, it suggests they are a side effect of the bioengineering, since it is well known that gene-splicing can produce such unexpected harmful effects.  Further, if not only their presence is unusual but also their hazards, then it is even more reasonable to regard the alteration of the bacterial DNA as the root cause of the epidemic and the altered filtration as an ancillary one.   

Such an unusual situation did in fact exist.  As already noted, the fatal batches of tryptophan contained at least one toxin that had never been found in any conventionally produced batches.  This toxin is case-related to the EMS.  Additionally, it and the five other case-related toxins were present in the tryptophan at an extremely low concentration, so low that standard chemical analyses did not discover any of them and determined that the tryptophan met accepted criteria of purity.  Whichever one of these toxins, or combination of them, caused the EMS is lethal at an extraordinarily low level of contamination.

The RC was clearly informed of these facts by several witnesses in their written submissions as well as their oral testimony.  Further, my submission provided an excerpt from a memo by the biotechnology coordinator of the U.S. Food and Drug Administration (FDA) stating that the genetic engineering of the bacteria could not be ruled out as the cause of the EMS.[vii]  I additionally informed the commission that many experts regard the bioengineering as the most likely cause.  Moreover, I directed them to a recent paper by researchers at the University of Hamburg stating that the use of genetic engineering in producing tryptophan generates problematic byproducts and “…restricts the possibilities of an effective clean-up procedure.”[viii]  I also noted that the issue of causation has not been definitively resolved because several factors initially prevented independent experts from examining the bioengineered bacteria and Showa Denko eventually destroyed them.   

In my oral testimony, I emphasized the seriousness of the implications of the tryptophan incident for GE food.  Numerous experts have cautioned that the gene-splicing process is inherently hazardous and can disrupt the function of the organism in ways that induce production of unintended and essentially unpredictable harmful substances.  The commission received testimony from many such experts, and I provided it with documentation from the U.S. FDA’s files showing that its own experts had voiced the same concerns and had strongly advised that all foods produced by GE be carefully tested in a way that screens for the presence of such harmful substances. (This will be discussed in greater detail in a later section.)  During my appearance before the commission, I pointed out that the kinds of tests the FDA scientists called for have not been implemented anywhere and that ANZFA’s publications clearly reveal it does not require them and instead bases its regulation on the presumption that GE foods will not contain unexpected harmful substances.

I emphasized that the main lesson to be drawn from the tryptophan calamity in regard to GE food is the need for substantial caution, especially considering:   

• The evidence strongly suggests the epidemic was caused by unexpected toxins that resulted from alterations in the metabolic processes of the bacteria induced by changes to their DNA.   
• The metabolic processes of food-yielding organisms can likewise be disrupted through gene-splicing and yield unexpected harmful substances.
• Because fruits, grains and vegetables are not passed through filters to remove hazardous ingredients prior to consumption by human beings, to dismiss the tryptophan epidemic as essentially a problem of inadequate filtration is both inappropriate and irresponsible.
• Unlike the toxins involved in the tryptophan tragedy, many harmful ingredients that can be generated through bioengineering cause damage in a gradual, cumulative way that could take many years to detect. 

 In his testimony, molecular biologist Dr. Robin Ord pointed out that by conventional means of assessment, the toxic tryptophan had been shown to be “substantially equivalent” to normal tryptophan, given that laboratory analysis determined it met pharmacological standards of purity.  He emphasized that prior to the epidemic, the GE-derived tryptophan was by all indications far more equivalent to its conventional counterpart than are any of the GE foods currently on the market.  Yet, it killed and crippled a large number of people.  This underscores the importance of supplementing the current testing regime that cannot adequately screen GE foods for unexpected side effects with tests better able to do so. 

Nonetheless, although the RC report lists both Dr. Ord and me as sources for the tryptophan section, its actual discussion does not include any of the specific points mentioned above, nor does the commission appear to have paid them much serious attention.  It is difficult to see how the members could have considered such evidence in an open-minded, fair manner and still have gone on to endorse the current system of safety assessment that is based on tests that do not reliably monitor GE foods for unexpected side effects.  While there are reasonable grounds for the commission to argue that because no direct link was established between bioengineering and the EMS, “the incident cannot be taken as clear evidence of the inherent risks of genetic modification,” it is unreasonable for the commission to act as if the incident does not warrant the exercise of greater prudence.   

The commission’s discussion of the L-Tryptophan disaster is seriously incomplete and grossly inaccurate.  Rather than acknowledge the evidence that indicates the need for a more precautionary approach to GE foods, the commission ignored it and distorted the facts so as to minimize the incident’s importance.   

The RC’s imbalanced handling of the toxic tryptophan incident is not an aberration.  Throughout its discussion of GE food, it engages in selective reporting that downplays risks and presents claims of safety as better buttressed than they in fact are, as is clear from the following examples.   

The report incorporates a false claim about the findings of one of the largest scientific conferences held on the safety of GE foods.   
In its discussion of how the risks of GE foods may have been overestimated, the report cites the witness brief of Dr Brian Jordan for the statement that the OECD Conference of February 28 – March 1, 2000, “concluded that GM food was not a health risk.”[ix]  Dr. Jordan is Director of the Nutrition and Health Institute at Massey University, and it is clear from his brief he is a staunch proponent of GE food.  However, his brief is unclear about where he got his information, since he provides no reference for it.  This lack becomes more understandable when one discovers that the official conference documents record no such conclusion as having been made and instead acknowledge that GE foods do indeed pose risks.  For instance, the formal rapporteurs’ summary states that one of the basic points of agreement was: “Benefits as well as risks posed by GM foods should be evaluated.”[x]  It adds: “There remains uncertainty about the potential long-term effects of GM food on human health and on worker safety (as a result of exposure during production).  Current methods for testing toxicity and allergenicity … leave some uncertainties and need to be improved.”[xi]  The summary also notes: “There is disagreement whether GM foods in animal feed presents a problem either for animal or human health.”[xii]  

In fact, the very notion that the conference reached a uniform conclusion about the level of risks is out of line with its stated aims.  According to the report of the conference chairman, Sir John Krebs:  “The conference was not aimed at producing a simple consensus, but rather at identifying areas of greater agreement, of divergence of opinion, and of uncertainty due to lack of knowledge. Even the very basic question of whether or not GM technology is fundamentally different from genetic modification through conventional breeding was one on which there was not a consensus amongst the participants.”[xiii]  

Dr. Jordan’s assertion blatantly mischaracterizes what occurred at the OECD conference, the largest scientific conference on the safety of GE foods that had yet been held.  Further, its unequivocal wording renders it suspect, since, as numerous witnesses at the RC hearings acknowledged, no food is entirely risk free.  The RC should have verified its accuracy before employing it as the sole representation of what such an important conference concluded.  The commission was irresponsible in failing to do so, especially since the chairman’s report was in its files and the rapporteurs’ summary is on the OECD website.  Had it included the actual statements of the rapporteurs instead of Dr. Jordan’s false representation, its report could not have so systematically discounted the risks of GE foods.       

The commission disregarded extensive evidence from U.S. government experts that highlights problems of GE foods. 

Not only did the RC include in its report a questionable claim from a biotech advocate without first checking evidence that was easily obtainable, it excluded well-substantiated evidence about risks that was clearly brought before it.  In my witness brief and oral testimony, I informed the commission of extensive memoranda written by scientific staff of the U.S. Food and Drug Administration discussing the risks of GE foods.[xiv]  These memos clearly state that GE foods entail unique risks, especially the risk of containing unintended and essentially unpredictable new substances that could be harmful to human health.  They caution that in order to screen for such risks, every GE food must be subjected to rigorous testing that includes toxicological feeding studies employing the whole food, not just an extract of the foreign protein that is known to be present.   

I provided substantial excerpts from these memos, and I noted that photocopies of the full documents are available on the Alliance for Bio-Integrity website.  I further explained:

• My organization obtained these memos by bringing a lawsuit against the FDA in which the agency was required to provide us copies of its internal files on GE foods.
• The predominant opinion among the FDA experts was that GE foods entail unique risks.
• That this is clearly evident from a memo by an FDA official responsible for reviewing the expert input that stated: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks."[xv]
• That this information was not widely known because the FDA’s politically appointed administrators, operating under a White House directive “to foster” the biotech industry, covered up their scientists’ warnings, professed themselves “not aware of any information” showing that GE foods differ from others, and allowed GE foods to be marketed without testing based on the claim there is an overwhelming consensus among experts they are safe.
• That during the lawsuit, the FDA did not challenge the above characterization of what the memos say nor attempt to demonstrate that other of its scientists held opposite opinions about the risks of GE foods.
• That the court made no formal determination about the extent to which the memos reflect the opinion of the FDA scientific staff but rather ruled that as a matter of federal administrative law, the politically appointed administrators had discretion to disregard their scientists’ input.
• Although ANZFA does require testing, its assessment process is based on the presumption that GE foods do not entail a higher risk of unexpected side effects than do conventional foods and that the tests on which it relies do not monitor for such effects in the manner prescribed by the FDA experts.

Nonetheless, nowhere in the RC report is there mention of the statements of the FDA scientists about GE foods.[xvi]  However, the commission did see fit to include a statement about the FDA’s knowledge base from Brenda Cutress, a lawyer who serves as the executive director of the New Zealand Grocery Marketers Association.  In its discussion of how risks might be overestimated, the report cites Ms. Cutress for the proposition that: “If very little was known about genetically modified foods, even a suspicion of harmful effects might deter their being marketed. But a considerable amount is known, which has allowed regulatory agencies around the world, such as the … FDA, to state that genetically modified foods are as safe as conventional foods.”[xvii]  It is quite odd for the report to include an assertion from a non-scientist proponent of GE foods that the FDA’s claim they are safe is based on “considerable” knowledge while excluding the statements of the agency’s own scientists cautioning that they entail unique risks – and that none can be considered safe unless it has been confirmed so through the kinds tests that have yet to be implemented.  While it is understandable the commission would refrain from expressing an opinion about the moral integrity of the FDA administrators, it is inexcusable that they avoided any mention of the input those administrators received from their scientific staff.   

Further, when the commission does refer to my presentation, it says: “Mr. Druker, an American public

interest attorney, who was representing nine scientists in a lawsuit against the FDA, related a number of concerns about genetically modified food, and also questioned the soundness of FDA policy, which he described as ‘irresponsible and immoral’.”[xviii]  My words were extracted from one of the section headings in my witness brief that reads: FDA Policy is Irresponsible and Immoral.  In that section, I summarized and quoted from the memos of the FDA experts and explained how the FDA decision-makers covered them up and then claimed they had no information showing GE foods differ from others in any meaningful way.  However, the report does not specifically mention any of this but merely says I “related a number of concerns” about GE food, which in no way implies that the concerns were voiced by the FDA experts, or by anyone with expertise.  By printing my accusation without describing the extensive evidence I gave in support of it, the report abets the FDA cover up while it tends to marginalize me by giving the impression I make extreme statements that lack substantiation.       

The commission’s treatment of the issue of GE animal feed is one-sided and omits key information it received about risks. 

As the report presents things, only non-experts appear to have concerns about the safety of these feeds.  For instance, it says: “ANZFA acknowledged that concerns were raised from time to time about the human health consequences of the feeding of genetically modified feed to animals.”[xix]  It also notes that the Green Party raised concerns.  But the only experts it mentions are those who accept the safety of GE feeds.  It never refers to experts who have raised concerns, and the general impression it conveys is that it knows of none who have.  

This is strange, because the commission was informed of substantial concern expressed by experts at high levels of authority.  For instance, my witness brief cited a memo from the director of the U.S. FDA’s Center for Veterinary Medicine (CVM) to the agency’s biotechnology coordinator in which he noted that GE plants have the potential for “unintended” side effects.  He then stated: "... CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns."[xx]  He explained that residues of unexpected substances could make meat and milk products harmful to humans.  He said that he and other scientists at CVM have concluded that GE products need to be monitored for safety before they are marketed as animal feeds.  He called for well-controlled studies on farm animals that employ the whole food and that include clinical blood chemistry profiles and gross pathology.  During my appearance before the commission, I discussed this memo and emphasized its importance.[xxi] 

Further, as the preceding discussion has shown, had the RC read the official summary of the OECD conference instead of relying on Dr. Jordan’s false representation, it would have learned that the concerns expressed by the US government’s experts were shared by many experts at the conference.  As the rapporteurs noted:  “There is disagreement whether GM foods in animal feed presents a problem either for animal or human health.” 

Yet, not only did the commission fail to evaluate Dr. Jordan’s dubious claim by checking evidence that was easily obtainable, it even passed over the evidence from the CVM that was clearly brought before it.  The report makes no mention of the CVM memo, nor does it appear to have taken any account of it, since it expresses no interest in whether existing research has utilized the modes of testing the CVM experts concluded are necessary.  Rather, the commission members assure themselves and the reader about the safety of GE animal feeds by referring to studies that are not capable of effectively screening for the types of unintended side effects that GE can generate.  Their report notes that ANZFA “cited information” from the Federation of Animal Science Societies to the effect that no foreign DNA or protein had been discovered in meat, milk and eggs from livestock fed GE products.  It also refers to a report prepared for the Ministry of Health that reproduced a review by Dr Marjorie Faust at Iowa State University of 40 livestock studies.  The RC says these studies were “designed to detect any unintended effects” of GE feed and “had been consistent in finding no detrimental effects in [the] livestock.”[xxii]  However, as in so many other instances, the commission has it wrong.  

I phoned Dr. Faust and learned that the 40 studies she reviewed were not broadly designed to detect “any” unintended effects but merely to discover whether the foreign DNA and the resultant foreign protein that get implanted in the crops are later found in the animals that eat them.[xxiii]  Another paper by Dr. Faust, published in 2001, indicates that to the extent toxicological studies have been performed on GE crops, they have not involved the whole plant but have been limited to the administration of high doses of an isolated extract of the known foreign proteins to lab animals such as mice.  She states that other forms of safety testing have not been considered necessary.[xxiv] 

Thus, none of the studies referenced by the RC was designed to screen for the range of unintended effects as discussed by the FDA experts, and none employed all the basic features it said were required.  The concerns expressed by the FDA experts about the potential for the meat, milk and eggs of livestock fed GE crops to contain harmful new substances other than the foreign DNA and protein known to be in those crops – or to contain harmful new configurations of substances that are ordinarily present – have yet to be addressed by appropriate testing.  The RC should have understood this, and it should have reported what the FDA experts said and how their cautions continue to go unheeded.  Instead, it incorrectly states that numerous tests “designed to detect any unintended effects” on the livestock have been performed – yet another instance where its positive picture of GE crops is fashioned by excluding key information about risks while making overstatements, and even false statements, in support of their safety.   

The Report badly mischaracterizes and unjustly disparages the research by Ewen and Pusztai.            

The research on GE potatoes conducted by Drs. Stanley Ewen and Arpad Pusztai at the Rowett Institute has received great attention because it is one of the few safety assessments that employed a whole GE plant in controlled feeding studies, and its results have been troubling.  The researchers derived two lines of transgenic potato from the same parent line by splicing in a gene that produces a lectin referred to as GNA, a natural insecticide.  Chemical analysis revealed statistically significant differences between each line of GE potato and the parent line in several constituents that are of major nutritional importance.  Extensive feeding trials with young rats also indicated statistically significant differences between the GE lines and their parental line in general metabolism, organ development and immune responsiveness.  These results cannot be fully attributed to the GNA, because the researchers also fed rats parent line potatoes spiked with GNA at a much higher level than is expressed in the GE potatoes and found no significant differences.  Ewen and Pusztai therefore conclude that a major part of the compositional and performance differences of the GE potatoes was induced by the genetic engineering process, possibly through disrupting the function of the potatoes’ own genes. 

Because of the serious implications of this research, many proponents of GE foods have endeavored to find flaws in it and have strongly criticized it.  On the other hand, many experts have reviewed the research and concluded it is sound. 

The Royal Commission strongly sides with the critics.  Its report attributes the differences detected in the feeding studies to the fact that raw potatoes were used: “Rats do not like to eat raw potato, and a standard 110-day trial had to be abandoned after 67 days, because the rats were starving.  Starvation affects gut histology, and the lining of the gut of control rats eating unmodified potatoes was shown to be abnormal. This led to confusion regarding the significance of Dr Ewen’s histological results, particularly to the reported ‘over growth’ of gut epithelial cells of rats eating genetically modified potato.”[xxv] 

The report’s argument is seriously defective, ignores many key facts, and contains false assertions.  First, there were four major studies, and only one was designed to last 110 days.  The other three were completed in 10 days, and even though the version of the longer one that used raw potatoes ended earlier than planned, it still yielded significant results.  Second, all four tests showed significant differences in several physiological indices between rats fed GE potatoes and those fed on the non-GE ones (the control group).  The changes were not limited to alterations in gut lining.  In all, 39 statistically significant differences were found (by independent multivariate statistical analysis), of which no more than five could have been the result of random error.[xxvi]  Further, whatever negative effects the raw potato diet had on the control group were of significantly less magnitude than the effects observed in the rats eating the GE potatoes, which indicates that something unique to the GE potatoes was also a causative factor.  Third, it is not true that the rats were “starving.”  They were continuing to put on weight, but not at the rate required by UK government regulations on animal feeding studies.[xxvii]  Fourth, even starvation does not produce abnormal gut histology.  It merely contracts the gut.[xxviii]  Fifth, and most important, trials were also conducted using boiled potatoes.  On this diet, the longer study did run for a full 110 days.  As in the case of the raw potato diet, there were statistically significant differences between the rats eating GE and non-GE potatoes; and the commission was clearly informed of this fact.[xxix]  

Considering the evidence that was presented to the RC, it is astounding that their report attributes the changes in the rats to the raw diet while taking no account of the rigorous steps taken to control for its effects.  It is even more astounding that the report neglects to mention that boiled potatoes were also used and likewise yielded significant differences.  

Yet, the commission did not thereby exhaust its store of bogus assertions regarding the Pusztai research.  It adds:  “The presence of other potato toxins could also have had a confounding effect on cells in the intestine, especially since the potato lines were not substantially equivalent.”[xxx]  This seems to imply that any critical differences between the lines were independent of the genetic alteration, since the report offers the statement as an alternative explanation to the researchers’ assertion that the gene-splicing caused the differences in gut development.  However, Ewen and Pusztai both made it clear that the gene-splicing had induced the compositional differences, and the report even quotes Ewen to this effect.  Further, their methodology assured that any differences between the potato lines would be attributable solely to the genetic alteration, since the GE and parental line potatoes used in the experiment were grown alongside each other in a tunnel isolated from the environment and exposed to identical conditions.[xxxi] 

Therefore, if the GE potatoes contained a different potato toxin than did the parental line, or a higher concentration of a toxin also present in the other, this difference would have been an unintended effect of the gene-splicing.  Further, the RC had been repeatedly informed by other witnesses about the potential for gene-splicing to produce unintended changes in chemical composition, including the generation of new toxins.  Therefore, it should have acknowledged that the alterations in the rat intestines might have been caused not only by harmful substances that naturally occur within potatoes but by novel ones that do not – and that in both cases the harmful state of the engineered potatoes would be due to the engineering itself.  But the report does not take this route and avoids any acknowledgement that the gene-splicing caused changes to the rats.  Rather, it gives the impression that the critical compositional changes could have arisen independently of the genetic engineering without bothering to explain how this could have happened in such a tightly controlled situation.  

Continuing its critical treatment of the research, the report states:  “Within the scientific community there is general agreement that the results of Dr Pusztai’s experiment are inconclusive insofar as there were flaws in the process, and the project was incomplete. …  The Commission, having heard evidence directly from Dr Pusztai and his colleagues, is also of the view that the results are inconclusive. It was unfortunate that the process of peer review was pre-empted by premature media release, thus preventing further scientific assessment.”[xxxii]  

In making these assertions, the commission again plays fast and loose with the facts.  Dr. Pusztai explained to the RC that these tests formed one part of a broader research project and that even though that broader project was prematurely terminated, this particular part of it was complete and subject to full scientific assessment.[xxxiii]  Nonetheless, the report brands even this part of the project as incomplete and barred from complete assessment.  Further, the report provides no substantiation for its claim there is general agreement among scientists that the research is flawed.  Indeed, it is difficult to accept the validity of this claim in light of the fact that numerous experts have reviewed the research and supported its soundness – and that a prestigious journal such as The Lancet saw fit to publish it.  Dr. Pusztai informed the commission that The Lancet had six referees review the research and that four decided it should be published on the basis of scientific merit as well as public interest, that one thought it should be published only on the basis of public interest, and that one referee voted against publication.  He then said: “In face of such a clear-cut decision, Richard Horton [The Lancet’s chief editor] said it would have been unimaginable not to publish the paper.”[xxxiv]  He noted that Dr. Horton’s comment accompanying the research report stated that The Lancet was publishing it based on scientific merit as well as on public interest.[xxxv] 

Despite these facts, the RC report chides the researchers for having “pre-empted” the peer review process by prematurely discussing their findings with the media and “preventing further scientific assessment.”  Further, not only does the report falsely claim that peer review was prevented, it manages its presentation to provide not even a hint that the research was published in a peer-reviewed journal.  Nowhere in the main text or the references is there any mention of The Lancet, which is quite strange considering many references are listed for the discussion of the Pusztai research. 

The report further downgrades the research by stating: “Extensive testing carried out by Chinese researchers, similar to that described by Drs. Pusztai and Ewen, has not replicated their results.”[xxxvi]   Considering the report once again fails to back up a critical claim with any specific reference, and considering how unreliable its claims about research favorable to GE foods have been shown to be, it is reasonable to doubt the accuracy of this claim unless and until evidence is provided to substantiate it.  This presumption of inaccuracy is strengthened by the fact that during his appearance before the RC, Dr. Pusztai was asked if other researchers had tried to repeat his study, and he stated none had.[xxxvii]  That was on February 7, 2001.  Given Dr. Pusztai’s reputation for integrity, it is highly doubtful that any such study had been published in the standard scientific literature as of that date.  While it’s possible one got published between that time and the writing of the RC report, the report’s failure to reference the Chinese research it refers to provides no clue.  Further, it is highly unlikely that any researchers have actually replicated the essential features of the Ewen and Pusztai research in light of the fact that their project cost 1.6 million pounds.[xxxviii]   

I emailed Dr. Pusztai inquiring about the allegation that Chinese researchers carried out “extensive testing … similar” to his and failed to replicate his results, and he replied he did not know of any such research.  He said that the closest thing he could think of is a claim made by a Chinese scientist at the 2000 OECD conference that he tested GE sweet peppers using a design similar to the one that he and Dr. Ewen had employed and did not find any problems.  Obviously, even if this research on peppers is reliable, and even if it fully duplicated the Ewen and Pusztai methodology (which is doubtful), it has no bearing on the quality of their research on GE potatoes.  Further, it is difficult to know whether it was well conducted and is reliable, since it does not seem to have been published in a standard journal.  Further, although the researcher agreed to send Dr. Pusztai the research data as he requested, well over a year has passed and he has failed to do so.     

It is highly irregular that the commission did not ask Dr. Pusztai about this Chinese research when he appeared at the hearing so he could comment on it.  Instead, the RC chose to refer to it for the first time in its report when its spurious allegations could not be directly challenged.  

It is difficult to compare the actual facts of the Ewen and Pusztai research with the RC’s version of them and regard its report as a fair and adequate evaluation.  Far from being fair, the report appears significantly biased against the research, highly resistant to interpreting it as implying anything negative about GE foods, and unduly intent on discrediting it.  However, by consistently failing to recognize facts that bolster the research while frequently misstating others so as to discredit it, the report ultimately discredits only itself.   

The Report dismisses concerns about hazards of splicing viral promoters into GE foods on the basis of unsound arguments that ignore several of the concerns and do not adequately address the others. 

Almost every GE organism currently marketed as food has pieces of DNA from pathogenic viruses implanted within each of its cells.  Bioengineers have resorted to using them in order to overcome natural barriers to bioengineering.  Only by adding this viral material to the foreign genes spliced into the organism have the bioengineers been able to get them to function.  The reasons for this follow.       

A gene is a piece of information that codes for a particular protein.  Unless the gene is in the active mode, the protein for which it codes will not get expressed.  A gene only gets activated through the influence of an additional sequence of information attached to it, which biologists refer to as a “promoter.”  The promoter functions as the gene’s on and off switch.  

Ordinarily, gene expression is tightly controlled.  Every gene within a plant or animal has a promoter that is finely attuned to respond to specific biochemical signals so that it expresses its product in harmony with the organism’s needs.  This is an impediment to bioengineering, because when a gene is taken from one species and spliced into an unrelated one, the promoter attached to it will rarely (if ever) receive the signals to which it is responsive and will therefore keep the gene inactive virtually all of the time.  To surmount this barrier, bioengineers remove the native promoter from the gene they wish to use and then fuse that gene to a promoter taken from a viral gene.  The particular promoter they use can stimulate expression of its gene in a wide range of cellular environments, which enables the virus from which it comes to infect many types of plants.

Through this artificial boosting, the transplanted gene functions in important respects like an invading virus – deeply different from the way it behaves within its native organism and from the way the engineered organism's own genes behave.  Because it is continually switched on, it acts independently of the host organism's intricate control system, in contrast to the harmonious coordination that exists among the native genes.  Consequently, not only does the foreign gene produce substances that have never been in that species, it produces them in an essentially unregulated manner that is uncoordinated with the needs and natural functions of the organism. 

Numerous experts have warned that the use of viral promoters in the creation of new food-yielding organisms entails the following hazards.   

a.       Because in most cases the foreign genes are in every cell of the organism, they can stress it by draining energy through their continual – and nonessential – activity.

b.      The promoters are powerful and in addition to influencing the foreign gene can cause erratic expression of some of the plant’s native genes.

c.       They can also activate metabolic pathways that are ordinarily inert.

d.      The unregulated production of foreign substances can disrupt complex biochemical networks.

e.       The promoter most commonly used (the CaMV 35S promoter) can facilitate abnormal genetic recombinations.

Each of these phenomena can induce (i) an imbalanced production of substances ordinarily present in the organism that is harmful to the consumer or (ii) the production of novel substances that could be toxic or otherwise harmful.  Further, the last one listed could also result in the activation of dormant viruses or the creation of new ones.  Moreover, because the artificial constructs containing the promoters are unstable, the promoters can transfer into other organisms, expanding the range for activation and creation of dangerous viruses.     

Although the commission was thoroughly informed of these concerns, it gives little discussion to most of them and attempts to allay them all with a shallow argument that disregards their essence.  In particular, the RC relies on the argument of Dr Daniel Cohen, a scientist in the Plant Health and Development group of HortResearch, who is a strong proponent of GE crops.  Its report says:  “Dr. Cohen told the Commission that CaMV was present in New Zealand brassicas and infection rates of up to 50% had been reported. He argued that the virus had clearly been part of the human diet in Europe, Asia and Australasia for a considerable period of time and that: ‘ ... if ... this virus has a tremendous power to recombine with other viruses and cause disease in other plants and animals, we might expect some evidence of remnants of the virus in other organisms. Extremely sensitive PCR tests have been developed to detect traces of the 35S in foods as evidence of GE ingredients. Such tests would be impossible if horizontal transfer had taken place.’”[xxxix]   

As presented, this argument deals only with the issues of viral recombination and gene transfer to other species (termed “horizontal gene transfer”) and does not even address hazards (a) through (d) above that involve metabolic disruptions caused by splicing the promoter into the organism’s DNA.  The closest it comes to these issues is by noting that the particular virus (CaMV) from which the promoter derives has infected many food-yielding plants in numerous countries.  However, there is a great difference between a plant that has been infected by a virus and one that has been genetically engineered to contain its promoter.  In the latter situation, the promoter has been a forced addition to the plant’s genome from its initial phase, has actively produced foreign substances in an unregulated manner in every cell throughout the entire developmental process, and has exerted an abnormal influence that could have disturbed metabolic functions in many ways.  In contrast, when CaMV infects a plant, the virus does not ordinarily get ingrained within the genome and its promoter drives the expression of its own genes, not genes within the target organism.  The organism’s own genes continue to be regulated by their own promoters in an orderly fashion.  So, the fact that humans have safely consumed vegetables that have been to some degree infected by CaMV is essentially irrelevant to the issue of whether splicing its 35S promoter into the DNA of edible plants could change their composition in ways that are harmful to the consumer.  Yet, the commission appears to think it has laid that important issue to rest by citing this irrelevancy.   

Further, although Dr. Cohen does address the issues of viral recombination and horizontal transfer, he does not adequately deal with them.  He argues that if the CaMV promoter had a tendency to recombine with other viruses and an ability to transfer to other species outside its ordinary range of infection, pieces of it should have entered the genomes of organisms belonging to some of these other species prior to the advent of bioengineering.  He claims that because the evidence indicates this has not happened to any substantial degree, there is no real danger it will now occur via genetic engineering.  

This argument fails to appreciate the major difference between the CaMV promoter in its natural state, when attached to its own virus, and in its artificial state stripped from its virus, fused into a conglomerate of genetic material derived from several different species, and then spliced into the DNA of a food-yielding plant.  Dr. Maewan Ho, an expert in genetics, repeatedly informed the commission that when the promoter is placed in an entirely new genetic and environmental context, it is less stable and can recombine and transfer more easily.[xl]  Nonetheless, the report essentially dismisses the significance of this information, fails to mention Dr. Ho’s statements, and instead relies on an argument that does not refute the difference between the promoter in its artificial versus its natural state but merely assumes, on the basis of no evidence, that it does not exist.  Thus, the report once again overrides legitimate concerns about hazards with assertions from a biotech proponent that do not effectively address them and in no way counter their basic thrust.
The Commission Disregarded Extensive Evidence Showing that ANZFA’s Assessment Procedure is Seriously Flawed

In concluding that it would not be in the best interests of New Zealand to ban GE food, the RC adds,

“We do, however, consider that consumers should be protected by rigorous scientific assessment processes ….”[xli]  The commission further concludes that the Australia New Zealand Food Authority (ANZFA) is providing such assessment “conscientiously and soundly.”[xlii]

This conclusion about ANZFA’s conscientious and sound practices regarding GE foods is contradicted by extensive evidence the commission received.  A detailed examination of much of the key evidence demonstrating the deficiencies in ANZFA’s treatment of GE foods and the irresponsible manner in which it has behaved is contained within the comments I submitted to ANZFA that accompany this document.  A summary of some of the important facts follows.

• The RC accepts and favorably reports ANZFA’s claim that the data it receives from the manufacturers of GE foods allow “a more rigorous analysis than could be done on the summary data submitted in support of publication of a scientific journal article.”[xliii]  Doing so, it ignores and fails to mention that Dr. Judy Carman, an expert in epidemiology as well as nutritional biochemistry who spoke on behalf of the Public Health Association of Australia, informed it in both her written and oral presentations that the manufacturers generally do not provide several items of information that are required by refereed journals, thereby preventing their studies from undergoing standard peer review.[xliv]
  
• It is illuminating to contrast the commission’s treatment of the industry submissions to ANZFA with its treatment of the Ewen and Pusztai research that revealed potential health hazards of a GE food.  In the process of disparaging the latter, its report falsely states that the researchers had prevented peer review while it avoids any reference to the fact that their research was published in a prestigious peer-reviewed journal.  But in the case of the research submitted by the biotech corporations to gain approval for putting their GE foods into the human food supply, the report disregards and even hides the fact that most of it is so deficient it cannot be peer reviewed – while instead giving the impression it is suited for more rigorous review than is the research submitted to peer-reviewed scientific journals. 

The RC report states that ANZFA’s chief scientist Dr. Marion Healy “…confirmed that the Authority would have particular concern about the potential for the production of a protein of unknown function or unknown impact.”  Yet it fails to mention that Dr. Carman informed it that GE plants have been “routinely” shown to differ to a statistically significant degree from their non-GE counterparts in amino acid composition and that ANZFA has approved some in which such differences are evident from the data supplied by the manufacturer.[xlv]  She cautioned this could well indicate that a new protein had been produced and that there should have been follow up testing to make sure none had.  However, the RC allowed Dr. Healy’s assurance to stand with no comment about ANZFA’s failure to translate its professed concern about new proteins into responsible action.

The RC report also accepts ANZFA’s claim that its safety assessments are in line with the guidelines set forth in the January 2001 report of the expert panel of the Royal Society of Canada – another instance in which the commission upholds a representation by the authority that is easily proven false. 

The Canadian expert panel clearly stated: 

a.       Assessments must be based on a “default prediction” that GE foods have undergone unexpected changes that could be harmful and should not presume that the only changes will be those that are intended and predicted. 

b.      Accordingly, there must be “direct testing for harmful outcomes” employing the whole food, not merely an extract of the expected new substance(s).  Tests should include those for “short and long-term human toxicity, allergenicity and other health effects.”

c.       Tests must be rigorously performed and subjected to peer review by independent scientists.

(For references and a more detailed discussion of the panel’s recommendations, see Section III of   my comments to ANZFA.)

The RC was provided substantial information demonstrating that ANZFA’s practices violate all of  these standards.  It’s own publications indicate that it relies on a default presumption that the only changes will be those that are intended.  The tests it accepts rarely employ the whole food and do not directly test for human toxicity and other health effects.  Further, as discussed above, most of the tests on which it relies cannot be subjected to standard peer review. 

The fact the commission could yet conclude that ANZFA was adhering to the standards  enunciated by the expert panel reveals far more about the competence of its own procedures than those of ANZFA.

Conclusion: The Report is so error-filled and biased that its recommendations should be rejected. 
The Royal Commission’s report is clearly not the unbiased, balanced assessment it was meant to be.  It systematically downplays and under-reports evidence suggesting hazards, even to the extent of excluding much of it, while it regularly relies on weak, unsubstantiated and sometimes false assertions from biotech proponents to counter and often override well-grounded concerns expressed by experts.  Further, its procedures are so loose and careless that it not only incorporates many false statements by others but also contains many blatantly false assertions of its own.  The report’s favorable findings and recommendations about GE foods squarely rest upon these many falsehoods and could not have been issued if the facts had been fully and accurately presented.     

Consequently, the report does not deserve the respect that is ordinarily due such a document.  Instead, the members of the commission owe the nation an explanation and also an apology for having consumed so much public money and the time of so many people in such an errant and irresponsible manner.

As the extensive information about the health hazards of GE foods that the RC report has suppressed becomes better publicized, it is to be expected that consumers around the world will resist them even more intensely.  Accordingly, if New Zealand agriculture invests heavily in GE crops, it will ultimately be the worse for it.  More important, given the unique risks entailed by these foods and the serious deficiencies in the current regulatory process, it is clear they pose an unacceptable health hazard and that none should have yet come to market.  

REFERENCES

Caudill, S.P., et al. Journal of Occupational Medicine and Toxicology, vol.2, no.1 (1993) pp.41-52; Kilbourne, E. Journal of Rheumatology Supplement, vol. 46, Oct. 1996
RC Report, p.43
Id.
Id. 
Report in press
RC Report p.43
Druker Witness Brief, p.10, citing FDA Administrative Record at 22,923: Alliance for Bio-Integrity, et al. v. Shalala, Docket No. 98-CV-1300, U.S. District Court for the District of Columbia
T.J. Simat, et. al. “Synthesis, Formation and Occurrence of Contaminants in Biotechnologically Manufactured L-Tryptophan,” Proceedings of the 9th International Meeting on Tryptophan Research, Hamburg, Germany, 10-14th Oct., 1998.
RC Report, para.101
Rapporteurs’ Summary, The OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods, 28 February - 1 March 2000, p. 3
Id. p.4
Id., p.3
Chairman’s Report, The OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods, 28 February - 1 March 2000, para. 5
Druker witness brief, paragraphs 9-12. Photocopies of relevant FDA documents are at www.biointegrity.org
Memo from Dr. Linda Kahl to the FDA Biotechnology Coordinator, January 8, 1992, p.2. FDA Document #1 at www.biointegrity.org
The closest it comes is by noting that one group said the FDA “has been shown to ignore its own scientists’ advice.” But it provides no further details and leaves the impression the advice could have been on other matters altogether.
Brenda Cutress testimony, Presentation by New Zealand Grocery Marketers Association, 27 Nov. 2000, p.210. Ms. Cutress’s full statement included the OECD and WHO as organizations that state GE foods “are as safe as conventional foods.” However, it has already been shown that the OECD conference of 2000 reached no such conclusion, and most official bodies other than the FDA do not make such assertions either. Rather, they merely state that they are not aware of any evidence demonstrating that GE foods are less safe, which is very different than positively asserting they are just as safe. 
RC Report, Chap. 8, para.147
Id. para. 123
Druker Witness Brief p.5. FDA Document #10 at www.biointegrity.org
Druker testimony, transcript of Jan. 30, 2001 pp. 3109-10
RC Report, Chap. 8, para. 123. 
The review by Dr. Faust the RC referred to is “Livestock Products – Composition and Detection of Transgenic DNA/Proteins”, published in Selected Proceedings from the Agricultural Biotechnology in the Global Marketplace Symposium. American Society of Animal Science, Savoy, IL. 2000. While some of the studies did assess how well the animals grew on GE feeds, such nutritional studies are not designed to assess the safety of the animals’ meat and milk, and they are no substitute for toxicological investigations. Further, although some studies also performed superficial compositional analyses of tissue and milk, these analyses do not adequately screen for the types of unintended side effects discussed by the FDA experts. 
Faust, Marjorie, “Biotech Crops for the Dairy and Livestock Industries,” Proceedings of the 2001 California Animal Nutrition Conference, pp. 76-86. 
RC Report p.209
Pusztai testimony, transcript of February 7, 2001 p.3430
Id. pp. 3435; 3441
Private communication from Dr. Pusztai. 
Ewen Witness Brief; Pusztai transcript p.3442
RC Report p.209
Pusztai transcript, p. 3406
RC Report p.209
Pusztai transcript p.3428
Id. p.3429
Id
RC Report p.209
Pusztai transcript p.3430
Id.
RC Report, Chap. 4, para. 21
Dr. Maewan Ho Brief, ES6.14; Maewan Ho Transcript, Jan. 30, 2000, pp. 3073-74; 3077.
RC Report, Chap. 8, para. 107 
RC Report, Executive Summary, p.2 
RC Report, Chap. 8 para. 141
Dr. Judy Carman transcript, Jan. 29, 2000, pp. 2967-68; Carman witness brief, executive summary, pp.1-3. 
Carman transcript p. 2968


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