Here is Dr Arpad Pusztai's second response to the claims of CSIRO biotechnologist, Dr Roger Morton, that GM foods are well tested and that there is a significant body of scientific literature supporting the safety of these foods.

This is highly recommended reading, raising many important questions about the adequacy of GM food testing and regulation. Amongst much else, Dr Pusztai deals illuminatingly with the controversial principle of "substantial equivalence" used to approve GM foods.

3 items:
1. ngin intro: background on the Morton - Pusztai debate
2. Dr Arpad Pusztai: Re - "Response to Pusztai and apology"
3. Dr Morton's "Corrected Bibliography
---

1. ngin intro on the Morton - Pusztai debate

In Dr Pusztai's first critique of certain of the claims made in a piece published on the AgBioView list by Dr Roger Morton, he showed the somewhat dubious nature of many of the 56 published 'papers' which Morton had assembled in support of his argument that GM foods are well tested.

Morton had claimed the items on his list were in the "vast majority" of cases "full peer-reviewed publications in journals" but Dr Pusztai carefully dissected the list to reveal that not only were the vast majority not peer-reviewed but that part of the list was actually made up by duplication and even triplication of certain papers.

Dr Pusztai showed that amongst Morton's 56 "papers" there were, in reality, only a handful of "full peer-reviewed" animal studies, ie the type of study most directly relevant to testing GM food safety:

“This makes a total of FOUR  PEER-REVIEWED animal study papers.  It is somewhat different from the 56 claimed.  Even when one considers the 6 not truly relevant compositional papers the grand total comes to 10.  I am afraid, if Morton is a true scientist he should know that the other 46 so-called papers making up the rest and the bulk of his "bibliography" would not be considered by anyone as proper peer-reviewed scientific papers.”

Dr Pusztai also pointed out that a number of relevant published animal studies had actually NOT been inluded in Dr Morton's list, and speculated as to whether, given that they were fully peer reviewed, their exclusion reflected the fact that they did not necessarily support Morton's thesis as to the safety of GM foods.

In his repsonse to Dr Pusztai, "Response to Pusztai and apology", Dr Morton apologised for the duplication of papers which he said had been accidental. Morton also said he had adjusted his list accordingly and that it now contained 53 rather than 56 papers [Morton's revised list is given at the end of this mail]. Dr Morton disputed Dr Pusztai's comments about the number of properly peer reviewed animal studies and claimed that when one included abstracts to meetings and compositional studies this made for a "substantial" number of "publications with actual data":

"I come up with 12 are publications in peer-reviewed journals that definitely report experimental data to back up their results - a little different to Pusztai's figure of 4. Another 8 of them are abstracts to meetings where it would appear from the title the authors are reporting experimental results. Presenting data at a meeting is a form of peer review.   When one considers how few GM crops are in the market place I think 20 publications with actual data is quite substantial. It seems to me that these publications cover the GM technologies that are in use commercially at the moment."

In his original piece on the AgBioView list, Dr Morton had also made particular reference to one of two published studies on GM foods by Dr Pusztai - J Nutr 129:1597-1603 - and, in his repsonse to Dr Pusztai's comments, Morton returned to this paper and challenged its title, "Expression of insecticidal bean a-amylase inhibitor transgene has **minimal detrimental effect** on the nutritional value of peas in the rat at 30% of the diet" [Morton's emphasis].

Morton claimed that the study in fact showed "no detrimental effect on the rats of the GM peas" even  at 65% of the diet and challenged Dr Pusztai as to  "where is the detrimental effect of the transgenic peas implied in the title? Why doesn't the paper have a title saying "Expression of insecticidal bean a-amylase inhibitor transgene has *no detectable* detrimental effect on the nutritional value of peas in the rat at 65% of the diet"?"  Morton repeated a comment of Dr Pusztai's, asking, 'did he forget that "the scientist must report his findings as he finds them and not what he/she thinks that he/she ought to have found." '

Finally,  Morton queried "comments he [Pusztai] has reportedly made concerning the 35S promoter [used in most GM foods]', asking if Pusztai really regarded the promoter as the source of problems in his study on GM potatoes.

Dr Pusztai's latest response to Morton, which we are also forwarding to the AgBioView list, is given below.

For the full text of Dr Pusztai's first response to Morton:  http://www.biotech-info.net/morton_claim.html

For the full text of Morton's reply, '"Response to Pusztai and apology": http://agbioview.listbot.com/cgi-bin/subscriber?Act=view_message&list_id=ag bioview&msg_num=931&start_num=

We will shortly be putting both Dr Pusztai's responses to Morton on the ngin website -- url to follow.

One final comment of our own. For Dr Morton to persist in excluding from his list Dr Pusztai's fully peer-reviewed Lancet-published study on GM potatoes, not to mention other peer-reviewed studies which may raise questions about GM food safety, while including such items as the Royal Society's attack on Dr Pusztai's work (item 49 in Morton's revised list) and many non peer-reviewed general review articles on GM foods and their safety, seems extraordinary, not least given that:

a) the motives and behaviour of the Royal Society have been brought seriously into question see: http://www.btinternet.com/~clairejr/Pusztai/puszta_1.html

b) the Royal Society reviewers, none of whom were nutritionists, did not even have access to a full account of Dr Pusztai's methodology see: http://www.btinternet.com/~clairejr/Pusztai/puszta_1.html 

c) Morton's implied reason for exclusion is that the list focuses on 'publications [which] cover the GM technologies that are in use commercially at the moment' BUT if you exclude Dr Pusztai's paper on that basis, you can hardly then include the Royal Society's earlier  review.

Clearly, Dr Morton's claimed rationale for compiling his list of research on GM food safety makes little sense. But then, as Dr Pusztai so ably exposes in his response below, what we are really dealing with, as so often with the defence of this technology, is in reality a propaganda exercise in the guise of science and rationality.

ngin
---

2. Dr Arpad Pusztai: Re - "Response to Pusztai and apology"

Dear Dr Morton,

We now seem to be playing silly games with numbers and other unfortunate deviations from what we really ought to be focusing on.  So let's first call an end to the numbers' game.

There were 56 so-called references in your initial piece, 5 of which were in fact duplicates or triplicates.  So, in the new list there should have been 51.  It took me half an hour to establish how 56 - 5 came to equal 53.  It appears that our J. Nutrition paper has been added to the list and a previously listed paper, which lacked a reference no. in the original list, has now acquired one.  However, otherwise the references were still the same as in the original list (although numbered differently), despite my rather commonsense criticisms. 

For a moment I thought that our Lancet paper might have now been included in the new list, as one of these two extras.  Alas, it was not to be because it was deemed to be "irrelevant to the discussion as to whether the GM food on the market is safe or not".  Clearly, even though this article and a few others in Domingo's list in Science were most definitely peer-reviewed papers, they obviously did not come up to the pro-GM scientists' standards, as exemplified by the 41 non peer-reviewed references in the original and in the amended list.

I am afraid, even now I and, I guess, a lot of other scientists would regard the contents of these 41 "references" as little more than opinions.  I pick out a few glaring examples at random.  How could articles such as that published in the FDA Consumer magazine (no. 45), the R&D Magazine (no. 48), or Canadian Newswire Oct 25 (no. 52), etc be regarded as superior to the peer-reviewed papers in Domingo's references in Science? 

This, I am sure, would require an explanation for most unbiased people.  Even abstracts given at scientific meetings are not much use because they very seldom contain much hard data and information and are of limited circulation.  In fact, regarding them as peer-reviewed publications places Dr Morton on very dangerous ground because most of our GM potato work has also been presented at scientific meetings and their abstracts were published in the proceedings prior to my talking about it during the TV interview.  Therefore, the original charge against us, i.e. that I prematurely gave details of our work without their having been first peer-reviewed, seems to lose its validity.

While reading the Morton "Response" I realised why it is so difficult to find common ground between the pro-GM believers and those scientists who take a more sceptical view of the soundness of the GM science and technology.  I would recommend that people should read the original piece posted on the AGBIOVIEW website at the beginning of December as it clearly describes a novel idea of refereeing:

    "Look at the bibliography above and you will see the vast majority of the [56] publications mentioned are full peer-reviewed publications in journals.  Some reports submitted to FDA, EPA etc are not peer-reviewed by journal editors but you can be sure they are peer-reviewed by the people at FDA and EPA."

Most scientists regard publishing their results in peer-reviewed journals as a difficult, sometimes painful and laborious job.  However, they still do this because we have not come up yet with a better and more responsible system for the dissemination of new results, ideas and concepts, so that other scientists could use them for their own work. This is the way science has progressed through the ages.  True, it is not foolproof but it is the best we have for the time being.

Personally, I would be extremely grateful if the biotechnology companies could prevail on their scientists to properly publish their work instead of using these bits of communications, articles etc, as typified by 41 references on the list. Currently they are preventing other scientists from incorporating the data in their own research and checking it. 

It would also be useful because then we would not have to play this silly numbers game.  I am sure, Dr Morton knows perfectly well that I am right. Let us all hope that science will win out at the end.

Incidentally, it is rather revealing that, in line with what has been maintained by the GM biotechnology industry, pro-GM scientists apparently do not expect to find any differences between GM and non-GM crops under any conditions in their research.  Otherwise the following passage in the Morton piece which states that "publishing the results of experiments where there is no difference between the treatments is very difficult - because there is not a Journal of Boring Results", would be meaningless. 

There is a second essential point about the perspective of pro-GM enthusiasts which needs to be understood. In Dr Morton's list, with the addition of our J. Nutrition paper there are now 5 peer-reviewed publications describing animal feeding studies done with diets containing GM crops.  Although one may not agree with some of the findings described in these papers and even criticise them, these are now part of the scientific debate on GM foods and I welcome that. However, it appears that the GM enthusiasts cannot embrace the idea of reciprocity or that there are usually two sides to any debate. Indeed, the word "to debate" in the pro-GM scientist's vocabulary apparently means "to agree" with the pro-GM point of view.  Dr Morton's piece has demonstrated this, if it has demonstrated nothing else, by leaving out the more sceptical references (including the Lancet paper and some others) from the list. 

Moreover, as I mentioned previously, the direct relevance of the 7 peer-reviewed compositional studies to the safety of GM food is somewhat debatable and the sooner this is realized by the pro-GM lobby the better it will be all round.  It needs to be understood that establishing compositional equivalence of macronutrients between GM and conventional crops, though important, is of rather limited value. 

As the present technology of genetic crop transformation cannot deliver GM crops which are predictably safe and have no unintended effects, some sceptics, quite rightly in my opinion, regard the use of the word "technology" as a misnomer.  Provision of tonnes of analytical data will not make up for the uncertainty as to whether the GM product is safe or not. 

A distinguished French scientist and regulator who was invited to give an official contribution at the OECD Conference in Edinburgh (incidentally he is not included in the "list" either) gave a brilliant example of the basic fallacy of "substantial equivalence" in macronutrient composition.  He said that although a BSE cow is substantially equivalent to a healthy one nobody would be happy to eat it.  Before scientific work had revealed the reason for the difference between the two animals nobody knew what to look for. Having identified that, when scientists try to identify which cow is infected with BSE they do not measure the macronutrient content of the cow but will look for the appropriate prion proteins (0.0000....% of the cow's weight) that makes the cow potentially lethal for herself and the humans eating it. 

The message is that you must first establish whether there is a difference between the GM crop and its conventional counterpart by short- and long-term laboratory animal testing and then, if there is, look for what chemical component(s) is/are responsible for this difference.  From there on, just like with the prions, it is relatively plain sailing: scientists will determine the changes in the content of this component(s) in the various lines of GM crops and then  physiologists/nutritionists/toxicologists will establish whether predictions based on the content of these (toxic, antinutritive, antihormonal, etc) components will be borne out by animal tests.  This is how science has worked in the past and I need to be persuaded by logical and factual arguments why this should not apply to GM crops.

I am glad to say that at least in one respect Morton's views and mine are similar.  No true scientist can (or will) ever say that a food is 100% safe regardless of whether its a GM or non-GM variety although we have in the past two years been bombarded by politicians telling us that, based on the best scientific advice, it is inconceivable that GM foods are not safe.

Unfortunately, it is the food processing industry's (and the regulators') cutting corners which is responsible for not properly testing novel foods and processes before allowing them onto the market.  However, as we know well, two wrongs do not make a right. Again we come back to BSE.  Why were those re-processed animal remnants not properly tested before feeding them to cows?  Or, why for that matter were the tryptophan supplements not properly tested before they poisoned and maimed so many people?  It is immaterial whether this effect was due to genetic modification or cutting corners with the purification of the product or both. A novel production method was introduced without testing the outcome. Incidentally, the newly produced tryptophan was also "substantially equivalent" to the non-toxic tryptophan produced by all other manufacturers (99% or better). 

At this point we must also confront this business about how, by demanding independent verification of GM safety, the "activists" imply that the industry-financed "laboratories are fraudulently producing results showing the food is safe when in fact it is unsafe".  In such a light Sir John Krebs' and the OECD Edinburgh Conference's final motto of "openness, transparency and inclusiveness" can also be regarded as questioning the GM industry's credibility.

The fact is that when one buys a second hand car one does not exclusively rely on the seller's assurance but, if one has any sense, also asks for an independent opinion.  Obviously, the industry does test their products but that also leaves room for independent testing.  The idea that there is a terrible quandry as to who is going to pay for this, because the public will not, rings rather hollow in the wake of the Cry9 Taco shell disaster because it was testing by a public NGO and not Aventis' scientists which alerted everyone to the problem of contamination. 

Perhaps the industry ought to set up a fund from which money could be used to support independent scientific investigations.  It would not only be in the interest of public safety but the GM companies would also clearly benefit if independent research workers found that their products presented no unacceptable health or environmental safety risks. Industry could only gain by such an endorsement, which inevitably leads one to ponder why there is so much difficulty about achieving such "openness, transparency and inclusiveness". Are the companies, in reality, afraid that the independent research scientists might find something negative about their GM products?  Certainly I (and I am told many others) had a great deal of difficulties in the past when we tried to obtain bona fide samples of GM and parent line crops from biotech companies for our testing.  And we did not even ask for their money, just for the samples.

In the Morton "Responses" there was a return to our GM pea paper.  It was quite revealing that, apparently, it was envisaged that there could be no possible detrimental effects of these peas on the rats.  Thus, there was a plea that the paper's title should have said that the GM peas had "NO DETRIMENTAL EFFECT" rather than minimal detrimental effect.   First of all, I should point out that the title was coined by T.J. Higgins and seconded by Maarten Chrispeels, neither of whom are known to be rabid anti-GM scientists.  Of course, they were right because although Dr Morton may think that the differences found could not be regarded as potentially detrimental, some more cautious scientists might regard the changes as potentially harmful.  Now there are two peer-reviewed papers, in addition to the FDA's own FLAVR SAVR tomato study, in which gut lesions have been found with GM foodstuffs in three different labs.  In this light, even though in the GM pea study there was no histology, the significant weight and compositional differences in the caecum (large intestine) and the increased weight (not significant) of the small intestine should have at least cautioned anyone against claiming no detrimental effects and suggested doing further and more relevant (histological, immunological, etc) studies to investigate whether these differences had any physiological significance. 

This is of particular importance when one takes into account that in practically all biological testing of GM crops the scientists use SPF and fully healthy rats or other animals.  No tests have ever been performed with animals which had problems with their digestive system, despite the fact that a very sizeable proportion of the human population has diseases of the alimentary tract, such as Crohn's disease, ulcerative colitis, intestinal and pancreatic tumours of all kinds, H. pylory and other bacterial infections, and a compromised immune system, etc.  Can anyone from the GM fraternity assure these people that they will suffer no ill effects when animal studies have already indicated the possibility of such?  I do not want to appear to be pedantic but we all must be reminded of the fact that once a GM crop is released we lose all control over it.  If the Taco shell disaster proved nothing else, it showed that neither the industry, nor the EPA or FDA are equipped to deal with a recall.  This places extra responsibility on scientists to be ultra cautious and not to claim that something has no detrimental effects just because their experiences are not wide enough to see possible problems.

In the "Response" document, in addition to an interpretation of the word "commercialization", there were again references to our potato study.  As I previously dealt with this point, I have nothing further to add apart from asking a question as to who would have done a "proper safety assessment including animal feeding studies" (on these GM potatoes) in the UK. After all, ACNFP, our regulatory authority, have no labs of their own and only ask for the companies to submit the results of their own testing. Incidentally, even this level of regulation is more rigorous than that in the USA where there is self-regulation and the FDA would not have required any such documentation, just a notification of the impending release of a new GM food crop.

There was also some query at the end of the "Response" document about the comments I have reportedly made about the CaMV 35 s promoter. According to (as it is claimed in the document) some unidentified activists (who keep popping up), I claimed that the transgenic potatoes behaved differently to non-transgenic potatoes spiked with the transgene product because of the 35 s promoter. 

I am now going to quote from our Lancet paper: "The possibility that a plant vector in common use in some GM plants can affect the mucosa of the gastrointestinal tract and exert powerful biological effects may also apply to GM plants containing similar constructs, particularly those containing lectins..." Or as in the Abstract: "Other parts of the construct or the genetic transformation (or both) could have also contributed to the overall biological effects...".  Perhaps, after all it may have been useful to include the Lancet paper in the list and quote its Abstract to prevent any misunderstandings.  One thing is, however, crystal clear that any mentioning of the 35 s promoter was conspicuosly absent from the paper even though that construct would have, of course, contained the promoter too.  However, a scientist can only refer to facts revealed by his/her studies and not, as it is often found nowadays, to his/her opinions. 

Finally, as referred to above, I do not necessarily agree with the view that we found no potentially detrimental effects with our GM peas.  We are back to the old claim by the GM protagonists that as there is no proof that human health is affected by GM food, it must be safe!  According to this line of argument, the only thing the GM biotech industry needs to do in future is not do any testing as then the myth of the safety of GM food will be maintained for eternity.  I am sure, to judge by present standards, that they are well on their way to achieving  this.
---

3. Dr Morton's "Corrected Bibliography - with some excerpts from Abstracts indicating papers where data has definitely been collected."

1.  Brake, J. and D. Vlachos. 1998. Evaluation of event 176 "Bt" corn in broiler chickens. J. Poultry Sci. 77:648-653. A 38-d feeding study evaluated whether standard broiler diets prepared with transgenic Event 176-derived "Bt" corn (maize) grain had any adverse effects on male or female broiler chickens as compared to diets prepared with nontransgenic (isogenic) control corn grain. No statistically significant differences in survival or BW were observed between birds reared on mash or pelleted diets prepared with transgenic corn and similar diets prepared using control corn.

2. Pusztai A, Grant G, Bardócz S, Alonso R, Chrispeels MJ, Schroeder HE, Tabe LM, Higgins TJV (1999) Expression of insecticidal bean a-amylase inhibitor transgene has minimal detrimental effect on the nutritional value of peas in the rat at 30% of the diet. J Nutr 129:1597-1603. The effect of expression of bean alpha-amylase inhibitor (alpha-AI) transgene on the nutritional value of peas has been evaluated by pair-feeding rats diets containing transgenic or parent peas at 300 and 650g/kg, respectively, and at 150 g protein/kg diet, supplemented with essential amino acids to target requirements

3. {Hammond, Vicini, et al. 1996 3399 /id}Hammond, B., J. Vicini, G. Hartnell, M.W. Naylor, C.D. Knight, E. Robinson, R. L. Fuchs, and S.R. Padgetteet al. 1996. The feeding value of soybeans fed to rats, chickens, catfish and dairy cattle is not altered by genetic incorporation of glyphosate tolerance. J. Nutr. 126: 717-727.  Animal feeding studies were conducted with rats, broiler chickens, catfish and dairy cows as part of a safety assessment program for a soybean variety genetically modified to tolerate in-season application of glyphosate. These studies were designed to compare the feeding value (wholesomeness) of two lines of glyphosate-tolerant soybeans (GTS) to the feeding value of the parental cultivar from which they were derived.

4. Padgette, S., N. Taylor, D. Nider, et al. 1996. The composition of glyphosate-tolerant soybean seed is equivalent to that of conventional soybeans. J. Nutr. 126: 702-716. The composition of seeds and selected processing fractions from two GTS lines, designated 40-3-2 and 61-67-1, was compared with that of the parental soybean cultivar, A5403. Nutrients measured in the soybean seeds included macronutrients by proximate analyses (protein, fat, fiber, ash, carbohydrates), amino acids and fatty acids. Antinutrients measured in either the seed or toasted meal were trypsin inhibitor, lectins, isoflavones, stachyose, raffinose and phytate. Proximate analyses were also performed on batches of defatted toasted meal, defatted nontoasted meal, protein isolate, and protein concentrate prepared from GTS and control soybean seeds. In addition, refined, bleached, deodorized oil was made, along with crude soybean lecithin, from GTS and control soybeans. The analytical results demonstrated the GTS lines are equivalent to the parental, conventional soybean cultivar

5. Sidhu, R.S., B.G. Hammond, R.L. Fuchs, J.N. Mutz, L.R. Holden, B. George and T. Olson. 2000. Glyphosate-Tolerant Corn: The Composition and Feeding Value of Grain from Glyphosate-Tolerant Corn is Equivalent to That of Conventional Corn (Zea Mays L.). J. Agric. Food Chem. 48:2305-2312.  The nutritional safety of corn line GA21 was evaluated in a poultry feeding study conducted with 2-day old, rapidly growing broiler chickens, at a dietary concentration of 50-60% w/w. Results from the poultry feeding study showed that there were no differences in growth, feed efficiency, adjusted feed efficiency, and fat pad weights between chickens fed with GA21 grain or with parental control grain.

6. Characterization of phospholipids from glyphosate-tolerant soybeans List, G. R.; Orthoefer, F.; Taylor, N.; Nelsen, T.; Abidi, S. L. (Food Quality and Safety Research, NCAUR, USDA, ARS, Peoria, IL, 61604, USA). J.Am. Oil Chem. Soc., 76(1), 57-60 1999 The phospholipids from 3 control and 2 glyphosate-tolerant soyabean cultivars were isolated by extraction of soya flakes with hexane and characterised after separation by HPLC. Several lots of commercial fluid lecithin were also analysed and the results were compared with values published in the literature. Phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol and phosphatidic acid were identified as major components in these cultivars and in the commercial lecithin samples. The results showed that glyphosate-tolerant soyabeans yield lecithin comparable and equivalent to conventional soyabean cultivars

7. Compositional Analysis of Glyphosate -Tolerant Soybeans Treated with Glyphosate Taylor, Nancy B.; Fuchs, Roy L.; MacDonald, John; Shariff, Ahmed R.; Padgette, Stephen R. (Monsanto Company, St. Louis, MO, 63198, USA). J.Agric. Food Chem., 47(10), 4469-4473 1999 The composition of the seed from soybeans sprayed with glyphosate was compared to that of a nonsprayed parental control cultivar, A5403. The nutrients measured in the seed included protein, oil, ash, fiber, carbohydrates, and amino acids. The concentration of isoflavones (also referred to as phytoestrogens) was also measured as these compounds are derived from the same biochemical pathway that was engineered for glyphosate tolerance. The analytical results from these studies demonstrate that the GTS soybeans treated with glyphosate were comparable to the parental soybean cultivar, A5403, and other conventional soybean varieties

8. Harrison, L.A., M.R. Bailey, M. Naylor, J. Ream, B. Hammond, D.L. Nida, B. Burnette, T.E. Nickson, T. Mitsky, M.L. Taylor, R.L. Fuchs and S.R. Padgette. 1996. The Expressed Protein in Glyphosate-tolerance Soybean, 5-Enolpryruvyl-shikimate-3-phosphate Synthase from Agrobacterium sp. Strain CP4, is Rapidly Digested in vitro and is not Toxic to Acutely Gavaged Mice. J. Nutrition 126:728-740.  There were no deleterious effects due to the acute administration of CP4 EPSPS to mice by gavage at a high dosage of 572 mg/kg body wt, which exceeds 1000-fold tha anticipated consumption level of food products potentially containing CP4 EPSPS protein.

9. Assessment of the endogenous allergens in glyphosate -tolerant and commercial soybean varieties Burks, A. W.; Fuchs, R. L.. Arkansas Children's Hospital, University of Arkansas for Medical Sciences, Little Rock, AR 72202, USA.. Journal of Allergy and Clinical Immunology (1995) Vol. 96, No. 6, 1, pp. 1008-1010

10. Berberich S.A., J.E. Ream, T.L. Jackson, R. Wood, R. Stipanovic, P. Harvey, S. Patzer, and R.L. Fuchs. 1996. Safety Assessment of Insect-Protected Cotton: The Composition of the Cottonseed is Equivalent to Conventional Cottonseed. J. Agric. Food Chem. 41:365-371. A comparison was made of the nutrient and antinutrient levels in the seed both to the parental variety and to published values for other commercial cotton varieties, as part of the safety and product assessment of these lines. Compositional equivalence confirmed the appropriateness of these cotton lines (531, 757 and 1076) for use in food and feed products. The insect-protected lines and the parental control were shown to contain levels of nutrients comparable to those of other commercial varieties. The levels of the antinutrients gossypol, cyclopropenoid fatty acids and aflatoxin in the seed from the insect-protected lines were similar to or lower than the levels present in the parental variety and reported for other commercial varieties.

11. Nida, D.L., S. Patzer, P. Harvey, R. Stipanovic, R. Wood and R.L. Fuchs. 1996. Glyphosate-tolerant Cotton: The Composition of the Cottonseed is Equivalent to Conventional Cottonseed. J. Agric. Food Chem. 44:1967-1974.  The composition of the cottonseed and oil from two glyphosate-tolerant lines, 1445 and 1698, was compared to that of the untransformed Coker 312 and to published values for other commercial cotton varieties. The nutrients measured were protein, fat, fibre, carbohydrate, calories, moisture, ash, amino acids, and fatty acids. The antinutrients measured included gossypol, cyclopropenoid fatty acids, and aflatoxins. In addition, the fatty acid profile and alpha -tocopherol levels were measured in the refined oil. These analyses demonstrated that the glyphosate-tolerant cotton lines are compositionally equivalent to the parental and conventional cotton varieties commercially available

12. Reed, A.J., K.A. Kretzmer, M.W. Naylor, R.F. Finn, K.M. Magin, B.G. Hammond, R.M. Leimgruber, S.G. Rogers and R.L. Fuchs. 1996. A Safety Assessment of 1-Aminocyclopropane-1-Carboxylic Acid Deaminase (ACCd) Protein Expressed in Delayed Ripening Tomatoes. J. Agric. Food Chem. 44:388-394. Tomato plants with delayed fruit ripening have been produced by stable insertion of the gene encoding the 1-aminocyclopropane-1-carboxylic acid deaminase (ACCd) protein into the tomato chromosome. Two approaches were used to assess the safety of the ACCd protein for human consumption. Purified Escherichia coli-produced ACCd protein, which is chemically and functionally equivalent to the ACCd protein produced in delayed ripening tomato fruit, was used in these studies. First, the ACCd protein was readily degraded under simulated mammalian digestive conditions. Second, the ACCd protein did not have any deleterious effects when administered to mice by acute gavage at a dosage of up to 602 mg/kg of bodyweight. This dosage correlates to greater than a 5000-fold safety factor relative to the average daily consumption of tomatoes, assuming that all tomatoes consumed contain the ACCd protein. These results in conjunction with previously published data, established that ingestion of tomato fruit expressing the ACCd protein does not pose any safety concerns

13. Biotechnology and the soybean. Rogers, Stephen G. (Monsanto, Brussels, Belg.). Am. J. Clin. Nutr., 68(6, Suppl.), 1330S-1332S 1998

14. Daenicke, R., D. Gadeken and K. Aulrich. 1999. Einsatz von Silomais herkF6mmlicher Sorten und der gentechnisch verE4nderten Bt Hybriden in der Rinderfhtterung - Mastrinder -. 12, Maiskolloquium. 40-42.

15. Aulrich, K., I. Halle and G. Flachowsky. 1998. Inhaltsstoffe und Verdaulichkeit von MaiskF6rnen der Sorte Cesar und der gentechnisch verE4nderten Bt-hybride bei Legenhennen. Proc Einfluss von Erzeugung und Verarbeitung auf die QualitE4t laudwirtschaftlicher Produkte. 465-468.

16. Faust, M. 1998. Determining feeding related characteristics for Bt corn. 1998 Dairy Report. Iowa State University, Ames, Iowa.

17. Faust, M. and L. Miller. 1997. Study finds no Bt in milk. IC-478. Fall Special Livestock Edition. pp 6-7. Iowa State University Extension, Ames, Iowa.

18. Faust, M. 1999. Research update on Bt corn silage. Four State Applied Nutrition and Management Conference. MWPS-4SD5. 158-164.

19. Folmer, J.D., G.E. Erickson, C.T. Milton, T.J. Klopfenstein and J.F. Beck. 2000. Utilization of Bt corn residue and corn silage for growing beef steers. Abstract 271 presented at the Midwestern Section ASAS and Midwest Branch ADSA 2000 Meeting, Des Moines, IA.

20.  Folmer, J.D., R.J. Grant, C.T. Milton and J.F. Beck. 2000. Effect of Bt corn silage on short-term lactational performance and ruminal fermentation in dairy cows. J. Dairy Sci. 83 (5):1182 Abstract 272.

21.  Halle, I., K. Aulrich and G. Flachowsky. 1998. Einsatz von MaiskF6rnen der Sorte Cesar und des gentechnisch verE4nderten Bt-Hybriden in der Broiler mast. Proc. 5. Tagung, Schweine- und  GeflhgelernE4hrung, 01,-03.12.1998, Wittenberg p 265-267.

22.  Russell, J. and T. Peterson. 1999. Bt corn and non-Bt corn crop residues equal in grazing value. Extension News, June 30, 1999. Iowa State University Extension, Ames.

23.  Russell, J.R., M.J. Hersom, A. Pugh, K. Barrett and D. Farnham. 2000. Effects of grazingcrop residues from bt-corn hybrids on the performance of gestating beef cows. Abstract244 presented at the Midwestern Section ASAS and Midwest Branch ADSA 2000 Meeting, Des Moines, IA.

24.  Russell, J.R., D. Farnham, R.K. Berryman, M.J. Hersom, A. Pugh and K. Barrett. 2000. Nutritive value of the crop residues from bt-corn hybrids and their effects on performance of grazing beef cows. 2000 Beef Research Report -Iowa State University. p 56-61.

25. Assessment of the allergenic potential of foods derived from genetically engineered plants: glyphosate tolerant soybean as a case study Fuchs, R. L.; Eisenbrand, G. [EDITOR]; Aulepp, H. [EDITOR]; Dayan, A. D. [EDITOR]; Elias, P. S. [EDITOR]; Grinow, W. [EDITOR]; Ring, J. [EDITOR]; Schlatter, J. [EDITOR]. Ceregen (Monsanto Co.), 700 Chesterfield Parkway North, St. Louis, MO 63198, USA.. Meeting info.: Food allergies and intolerances: symposium. Food allergies and intolerances: symposium (1996 ) pp. 212-221. 38 ref Publisher: VCH Verlagsgesellschaft mbH. Weinheim. ISBN: 3-527-27409-X

26. Safety evaluation of glyphosate-tolerant soybeans Fuchs, R. L.; Re, D. B.; Rogers, S. G.; Hammond, B. G.; Padgette, S. R.. The Agricultural  Group, Monsanto Company, St. Louis, MO 63198, USA. Meeting info.: Food safety evaluation. Proceedings of an OECD-sponsored workshop held on 12-15 September 1994, Oxford, UK. Food safety evaluation. Proceedings of an OECD-sponsored workshop held on 12-15 September 1994, Oxford, UK ( 1996 ) pp. 61-70. 32 ref Publisher: Organisation for Economic Cooperation and Development (OECD). Paris. ISBN: 92-64-14867-1

 27. Herbicide tolerant soybeans: Why growers are adopting Roundup Ready varieties. Carpenter, J., Gianessi, L. AgBioForum 2(2), Spring, 1999

28.  ACNFP (Advisory Committee on Novel Foods and Processes). 1991. Department of Health Report on Health and Social Subjects, No. 38. Guidelines on the Assessment of Novel Foods and Processes. London (HMSO).

29. ADA. 1993. Position of the American Dietetic Association Biotechnology and the Future of Food. Journal of the American Dietetic Association. Vol. 93 (2) pp 189.

30. ASEAN, 1998. Primary Production Company (ed) Regulations for Agricultural Products Derived from Biotechnology. Proceedings of the ASEAN Workshop, April 1-2, 1998, Singapore.

31. Council on Scientific Affairs, American Medical Association 1991. Biotechnology and the American agricultural industry. J Amer Med Assoc 266(3):363-263.

32. FAO/WHO, 1991. Strategies for Assessing the Safety of Foods Produced  by Biotechnology. Report of a Joint FAO/WHO Consultation. World Health Organization, Geneva.

33. FAO/WHO. 1996. Biotechnology and food safety. Report of a Joint  JAO/WHO Consultation. FAO, Food and Nutrition Paper 61, Rome Italy. Food and Drug Administration (FDA). 1992. Statement of Policy: Foods Derived from New Plant Varieties. Notice, Federal Register 57:104; 22984-23005.

34. Health Council of the Netherlands. 1992. Safety of Food Produced by  New Biotechnology. Publication No. 92.03E. The Hague.

35. Health Protection Branch. 1994. Guidelines for the Safety Assessment  of Novel Foods. Vol. I and II. Health Canada, Ottawa. James, C. 1998. Global Review of Commericalized Transgenic Crops: 1998. ISAAA Briefs No. 8.  ISAAA: Ithaca, NY.

36. Japan Ministry of Health and Welfare (MHW). Guidelines for Foods and Food Additives Produced by the Recombinant DNA Techniques, 1996. (Japan)

37. Lavrik, P.B., Bartnicki, D.E., Feldman, J., Hammond, B.G., Keck, P.J., Love, S.L., Naylor, M.W., Rogan, G.J., Sims, S.R. and R.L. Fuchs. 1995. Safety Assessment of Potatoes Resistant to Colorado Potato Beetle. In Genetically Modified Foods, Safety Issues. K.H. Engel, G.R. Takeoka and R. Teranishi, eds. ACS, Washington, DC, pp 148-158.

38. Nordic Working Group on Food Toxicology and Risk Evaluation. 1991.  Food and New Biotechnology - Novelty, Safety and Control Aspects of Foods Made by New Biotechnology. Nordic Council, Copenhagen, Nord 1991:18.  Nutritional Center for Nutrition and Dietetics (NCND) 1996. Food Biotechnology: safe, nutritious, healthful, abundant, and tasty food. Nutrition fact sheet. Chicago, Illinois USA.

39. OECD (Organization for Economic Cooperation and Development). 1993. Safety Evaluation of Foods Produced by Modem Biotechnology: Concepts and Principles. OECD, Paris.

40. OECD. 1996. OECD Documents: Food Safety Evaluation. OECD, Paris. Official Journal of the European Communities. January 27, 1997. Regulation (EC) No. 258/97 of The European Parliament and of the Council. No L43-1 p 7.

41. Sanders, P.R., T.C. Lee, M.E. Groth, J.D. Astwood and R.L. Fuchs.  1998. Safety Assessment of the Insect-Protected Corn. In Biotechnology and  Safety Assessment, 2nd edition (Thomas, J.A., editor)

 42. Taylor and Francis, pp 241-256. WHO. 1995. Application of the Principles of Substantial Equivalence to the Safety Evaluation of Foods  and Food Components from Plants Derived by Modern Biotechnology. Report of a WHO Workshop. World Health Organization, Geneva. WHO/FNU/FOS/95. 1

43. Institute for Economic Affairs. Genetically Modified Nonsense (comprehensive report on biotech food safety) Thomas R. DeGregori, University of Houston http://www.iea.org.uk/env/gmo.htm Science June 26, 199220 Vol. 256 ; No. 5065 ; Pg. 1747; ISSN: 0036-807520 The safety of foods developed by biotechnology; Policy Forum20 BY: Kessler, David A. ;

44. Taylor, Michael R. ; Maryanski, James H. ; Flamm, Eric L. ; Kahl,  Linda Nutrition Today June, 1991 Vol. 26 ; No. 3 ; Pg. 15; ISSN: 0029-666X20  Food safety and technology; how engineered food additives might affect food industry and production to reduce toxins found in food

45. FDA Consumer magazine January-February 2000 Are Bioengineered Foods Safe?; by Larry Thompson OECD Reports October 1999 The Concept of Substantial Equivalence in the Safety Assessment of Novel Foods (http://www.oecd.org)

46. American Chemical Society, Washington, DC 1996 ACS Symposium Series  605 Genetically Modified Food: Safety Issues by Engel, Takeoko, Teranishi From symposium sponsored by the Division of Agriculture and Food Chemistry at the 208th National Meeting of the American Chemical Society, Washington,  DC Aug 21-25, 1994. http://www.acs.org http://www.acs.org/government/publications/eip_biotechnology.html

47. Biotechnology and food safety FAO Food and Nutrition Paper 61 Report  of a Joint FAO/WHO Consultation Rome, Italy, 20 September - 4 October 1996 http://www.fao.org http://www.fao.org/es/esn/biotech/introduc.htm

48. R&D Magazine November 1999 Beachy Speaks About the Safety of  Transgenic Foods; http://www.rdmag.com/features/11soy.htm20

49. Royal Society (UK) 1999 Review of data on possible toxicity of GM potatoes Source: http://www.royalsoc.ac.uk/st_pol54.htm

50. Nutraceuticals International November 1, 1999 NFPA affirms biotech  food safety to Senate US STATE DEPARTMENT ISSUES AN ELECTRONIC JOURNAL ON "BIOTECHNOLOGY: FOOD SECURITY AND SAFETY" November 2, 1999 Biotechnology: Food Security And Safety Focus, Economic Perspectives, October 1999

51. CHEMTECH. Safety consideration for food ingredients January 1998/ CHEMTECH 1998, 28(1), 40-46.

52. Canadian Newswire Oct 25, 199920 Genetically Enhanced Foods are Thoroughly Tested for Safety

53. Monsanto Company June 1998 Patricia R. Sanders, Thomas C. Lee, Mark E. Groth, Jim D. Astwood, and Roy L. Fuchs Safety-Assessment Of Insect-Protected Corn