The Problem with the Safety of Roundup Ready Soybeans.The following is a critique of the methods used by Monsanto in its assessment that its product, Roundup Ready soybeans, also known as glyphosate-tolerant soybean soybean, soya bean, or soy pea, leguminous plant (Glycine max, G. soja, or Soja max) of the family Leguminosae (pulse family), native to tropical and warm temperate regions of Asia, where it has been line 40-3-2, is safe for human and animal consumption. The methods critiqued are those that appear in the "Full Assessment Report and Regulatory Impact Assessment," written by the Australian and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. Food Authority (ANZFA ANZFA Australian New Zealand Food Authority ) as the result of a request that these soybeans be permitted into Australia. The main role of this food authority is the protection of Australia's public health and safety. However, its other roles include the promotion of fair trade and consistency between domestic and international regulations. ANZFA rarely performs any safety testing of its own, but tends to rely on information obtained from elsewhere, including applicant companies.
The conclusion of this ANZFA document was that these soybeans are safe for human consumption. I have written this critique to highlight my concerns about that conclusion.
Roundup works by inhibiting an enzyme that is necessary for the plant to synthesise certain aromatic amino acids Aromatic amino acids are amino acids which include an aromatic ring.
n. , or EPSPS. The genetic modification in Roundup Ready soybeans involves incorporating a bacterial version of this enzyme (from Agrobacterium species, strain CP4) into the soybean plant, giving the soybean protection from Roundup. In this way, the soybeans and any weeds can be sprayed with Roundup, killing the weeds and leaving the soybeans.
Because of the way that this gene was incorporated into soybeans, several other DNA sequences are also present. They are the cauliflower mosaic virus Cauliflower mosaic virus (CaMV) is the type member of the caulimoviruses, one of the six genera in the Caulimoviridae family, pararetroviruses that infect plants (Pringle, 1999). 35S promoter, the EPSPS chloroplast chloroplast (klōr`əplăst', klôr`–), a complex, discrete green structure, or organelle, contained in the cytoplasm of plant cells. transit protein (CTP CTP (cytidine triphosphate): see cytosine.
(1) (Computer-To-Plate) The production of printing plates directly from the computer without requiring film as an intermediate step. ) sequence from petunias and the 3' untranslated region of the nopaline synthetase gene (NOS3'). The ANZFA document completely omits discussion of the first and last of these and their proteins. For the petunia petunia, any plant of the genus Petunia, South American herbs of the family Solanaceae (nightshade family). The common garden petunias, planted also in window boxes, are all considered hybrids of white-flowered and violet-flowered species from Argentina. CTP, the applicant document states: "...it is generally accepted that the chloroplast transit peptides are rapidly degraded after cleavage in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body.
Within a living organism.
in vivo adv. by cellular proteases." That is, results from other general experiments are relied-upon and no evidence is provided that they have measured this to be the case in Roundup Ready soybeans.
The application states that the only new protein in these soybeans would be the EPSPS enzyme. They determined the ability of this EPSPS to be digested by setting up an in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.
In an artificial environment outside a living organism. mammalian gastric and intestinal mixture. It was not stated how this was done. It could involve something as primitive as a beaker beaker /beak·er/ (bek´er) a glass cup, usually with a lip for pouring, used by chemists and pharmacists.
a round laboratory vessel of various materials, usually with parallel sides and often with a pouring spout. on a laboratory bench with substances in it and stirred occasionally, not something that approaches a live gut. In vitro experiments should be repeated using at least a chemostat. In vivo experiments should also be done, to determine the digestibility digestibility
the proportion of a feed or diet which can be digested by the normal animal of the subject species.
see digestibility coefficient. of this enzyme and other proteins expressed in this plant, their effects on intestinal structure and function and any ability of this enzyme to cross the gut wall.
The document also states that as people cook soybeans before consumption, this would deactivate de·ac·ti·vate
tr.v. de·ac·ti·vat·ed, de·ac·ti·vat·ing, de·ac·ti·vates
1. To render inactive or ineffective.
2. To inhibit, block, or disrupt the action of (an enzyme or other biological agent).
3. the enzyme and thus people would not consume it. However, raw soybeans will be fed to cattle. Steak is often served medium rare to rare. Therefore, there is a possibility that people will consume this new still-functional enzyme in their diet. As this does not seem to have been considered by the applicant company, there seem to have been no studies measuring quantities of this enzyme in cattle tissue, the ability of the enzyme to persist during moderate cooking or the effect that the enzyme would have on animals including humans.
A common soybean product in people's diets is lecithin lecithin
Any of a class of phospholipids (also called phosphatidyl cholines) important in cell structure and metabolism. They are composed of phosphate, choline, glycerol (as the ester), and two fatty acids. Various fatty acids pairs distinguish the various lecithins. , used as an emulsifier emulsifier /emul·si·fi·er/ (e-mul´si-fi?er) an agent used to produce an emulsion.
An agent used to make an emulsion of a fixed oil. in food. The application classed lecithin as a food additive and so it was not even considered in the assessment.
Soon after the application for GM soybeans was submitted, an application was also submitted to ANZFA to permit the allowable limit of glyphosate glyphosate
herbicide and desiccant for grains. Heavy doses to birds cause soft shells on their eggs. in soybeans to be increased 200-fold. It appears that Monsanto may be expecting much higher levels of glyphosate to be in Roundup Ready soybeans, However, the soybeans assessed in the application were not treated with Roundup. They are therefore not equivalent to the soybeans that will come out of paddocks for human consumption. Experiments should be repeated with soybeans harvested from farms before a decision is made on their safety.
The applicant company compared Roundup Ready soybeans to ordinary soybeans for moisture, fibre, ash, protein, amino acids, fatty acids, seed storage, trypsin inhibitor, lectin lectin /lec·tin/ (lek´tin) any of a group of hemagglutinating proteins found primarily in plant seeds, which bind specifically to the branching sugar molecules of glycoproteins and glycolipids on the surface of cells. , isoflavone i·so·fla·vone
A flavonoid found in soy.
3-phenyl-4H-1-benzopyran-4-one; many of the naturally occurring estrogenic substances in pasture plants are isoflavones. , raffinose Raffinose
The best-known trisaccharide (oligosaccharide), widely distributed in higher plants. The best-known sources are cottonseed meal and the manna of Eucalyptus. and stachyose. They found no significant differences but the sample sizes used are not given in the ANZFA document. Nor are sample size calculations to justify the sample sizes that were used. If too small a sample size is used, any differences that may exist between Roundup Ready soybeans and ordinary soybeans will not be found. This is called the "Type I error," and is a serious scientific fault. For the amino acid analyses, they also stated that no difference would be expected between Roundup Ready soybeans sprayed and not sprayed with Roundup, without apparently measuring whether this would be the case. Yet Roundup is designed to interrupt the biochemical pathway that makes some amino acids.
A similar, and potentially more serious sample size problem (and Type I error) occurs in the animal experiments. Here, 10 rats per sex per group (presumably pre·sum·a·ble
That can be presumed or taken for granted; reasonable as a supposition: presumable causes of the disaster. this means 20 rats per group) were fed soy meal ad libitum ad libitum
ad libitum feeding
food available at all times with the quantity and frequency of consumption being the free choice of the animal. from ordinary soybeans and Roundup Ready soybeans at various soy meal concentrations. Twenty rats per group is a very small number of rats with which to try and find statistical significance. They measured total body weight, and at the end of the experiments, the weights of some organs. They appear to have done no biochemistry, immunology, full autopsy, histology (except on pancreas), etc. They only fed animals for four weeks. The document did not report any trends from the low-level consumption groups to the higher-consumption groups of rats.
Similar studies were done on chickens and cows, presumably to reassure farmers that Roundup Ready soybeans would not reduce the quality of their animal-derived end product. A reasonable number of chickens (60 birds/sex) were fed for about a month, but only breast muscles and abdominal fat pads seem to have been removed and weighed at the end of the study. Similarly, groups of 5-6 Holstein dairy cows were fed uncooked soybeans. This is a totally inadequate sample size and would not be expected to show any differences between the groups. Yet a difference was found. Roundup Ready soybean-fed cows produced more fat-corrected milk, explained as being due to a slight increase in food intake. This mirrored a similar result in the chickens, where a slight increase in food consumption was found. They also found "some minor differences between treated groups and the negative controls with regard to body weight gains and food consumption which may be related to palatability" for rats fed processed soy beans. Although s uch differences may have become significant with larger sample sizes, this does not appear to have been done and these results were not further investigated by the company.
Monsanto also investigated what was described as immunological effects of the soybeans. These were basically allergenic Allergenic
A substance capable of causing an allergic reaction.
Mentioned in: Echinococcosis effects. Their experiments were done on pooled blood samples, found Roundup Ready soybeans to be as allergenic as ordinary soybeans, and stated that as known allergens tend to be glysolated, and as the EPSPS was not found to be glysolated, there should be no extra allergenic effects from this soybean. They appear to have done no human trials, however, to test this hypothesis.
At least the following studies should be done by independent researchers before Roundup Ready soybeans are assessed as safe for human consumption:
1. Chemical analyses of Roundup Ready soybeans from farmers' fields to determine the range of glyphosate levels in such soybeans and how they compare to non genetically-modified soybeans.
2. Long-term feeding studies using laboratory animals of different doses of glyphosate to quite high levels, if they have not already been done.
3. Long-term feeding studies on laboratory animals, with (a) ordinary soybeans (control group), (a) Roundup Readyoybeans without Roundup applied and (c) Roundup Ready soybeans from farmers' fields (ie with Roundup applied). This would differentiate any health effects due to genetic modification vs glyphosate.
For these animal studies (ie, 2. and 3.), at least the following tests should be done: food intake, body weight, full biochemistry, full immunology, liver function, kidney function, tumor investigation, the rate of death in each group, and a full autopsy on the animals at death, including intestinal section and histology. Animals should also be allowed to breed to determine any effects in their offspring.
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , double-blind feeding trials should be done with human volunteers over at least several months. They should be randomly assigned to one of the three feeding groups as in point 3., above. At least the following should be measured: body weight, full biochemistry, full immunology, liver function, kidney function, allergenic potential and general health.
In countries where Roundup Ready soybeans are permitted, cohort studies containing low-level through to high-level consumers of this product should be established to follow people over many years to check for long-term health effects.
In summary, I believe that the scientific basis provided by the applicant company for considering that Roundup Ready soybeans are safe for animal and human consumption is seriously flawed. No other independent investigations seem to have been done. It could be expected that the safety assessments of other genetically modified foods may be as flawed.
Independent testing of these foods is urgently required, incorporating long-term animal and human experiments. As these will take years, it would be wise to place a moratorium on these foods for five years, as suggested by European groups, the British Medical Association The British Medical Association (BMA) is the trade union to which the vast majority of British doctors belong. It is based in Tavistock Square in central London. It owns the "British Medical Journal". and the Public Health Association of Australia, while these investigations are done. To do otherwise could be likened to permitting a giant feeding experiment on millions of people.
Furthermore, the description that oils and other products derived from genetically-modified foods contain no genetically modified material is also flawed. It could not be expected that such products would be so pure that they would contain nil plant tissue or genetic material or protein. To expect this would be to expect the equivalent of analytical-reagent grade chemical purity chemical purity,
n the degree to which a substance is undiluted or unmixed with extraneous material, typically expressed as a percentage (%). from a food-stuff. These products also need rigorous testing, as described above.
Finally, the applicant companies appear to be resisting the labelling of genetically-modified foods or their derived products, such as oils. In countries where these foods and their derivatives are permitted, they should be labeled so that consumers can make their own decision about whether to buy them or not, and so that consumers can reassess their decision as information is provided about the relative safety of these products over the next few years.