Wednesday, March 23, 2011

Substantial equivalence- anything but equivalent or substantial

Substantial equivalence. When looking at these two words many come away with the impression that they signify fairness, safety and adequate disclosure to consumers regarding the products those words are attached to. However, regarding the marketing of transgenic foods specifically genetically modified organisms in our food that is anything but the case. I think it is crucial that consumers are aware of what is in their food and how it may affect them and their children in order for them to be able to make informed decisions about what goes into their bodies. This knowledge is essential as a preventative measure to maintaining health and also regarding informing consumers about any other effects what they buy may have on the enviroment. Therefore, in discussing substantial equivalence in regards to GMOs and the underlayer of collusion involved in pushing them into the world I think it important to begin at the beginning.

This is the standard definition of "substantial equivalence":

"Substantial equivalence is a concept developed by OECD in 1991 that maintains that a novel food should be considered the same as a conventional food if it demonstrates the same characteristics and composition as the conventional food."

This concept was pushed in regards to GMOs by the FAO and the WHO in the early 1990s. Its intent was the stripping away of years of testing of so called "novel" foods which can be prohibitively expensive and time consuming and therefore would have affected the profits of companies like Monsanto that have a virtual stranglehold on the FDA, USDA, and other regulatory agencies and governments that have afforded them special treatment in allowing them to use this planet and its species as one huge science experiment. The residual effects of applying these two words to GMOs and in allowing them to be foisted upon the world with little to no adequate testing already negates the validity of applying the substantial equivalence label to them.
This is from a paper written in 1997:

John Fagan, Ph.D., Professor of Molecular Biology, Maharishi University of Management

"The concept of substantial equivalence has been used in Europe, North America, and elsewhere around the world as the basis of regulations designed to facilitate the rapid commercialization of genetically engineered foods. For instance, European Commission (EC) regulations concerning novel foods and food ingredients apply the concept of substantial equivalence to both the safety testing and to the labeling of genetically engineered foods. Genetically engineered foods classified as substantially equivalent are spared from extensive safety testing on the assumption that they are no more dangerous than the corresponding non-genetically engineered food (1). Using similar arguments, genetically engineered foods classified as substantially equivalent are not required to be labeled as genetically engineered (2). The effect of these regulations has been to allow genetically engineered foods to enter the market place without sufficient testing to assure safety and without sufficient labeling to allow consumers to de cide for themselves whether or not to purchase and eat these novel foods. The health of the population of Europe is thus being placed at risk.

The fundamental inadequacies of this approach have been discussed previously. For instance, one article presented in the Proceedings of the Organization for Economic Cooperation and Development (OECD) Workshop on Food Safety Evaluation (3), came to the following conclusions: (1) Because the concept of substantial equivalence has no dimensions, it cannot be used as a predictor of which novel foods will require substantial safety testing in animals. (2) Depending on the nature of the novel food, the usefulness of the concept of substantial equivalence in determining the necessity for extensive safety testing ranges from useful to negligible. (3) The number and range of safety tests required is best determined, not by the concept of substantial equivalence, but by the nature of the product under consideration.

At first glance the term substantially equivalent implies that two foods are equivalent in all characteristics that are of importance to the consumer-safety, nutrition, flavor, and texture. However, in actual practice the investigator compares only selected characteristics of the genetically engineered food to those of its non-genetically engineered counterpart. If that relatively restricted set of characteristics is not found to be significantly different in these two, the genetically engineered food is classified as substantially equivalent to the corresponding non-genetically engineered food and is required to be neither tested further nor labeled as genetically engineered.

The argument supporting this practice is that since most of the characteristics of a particular genetically engineered food are similar to those of its non-genetically engineered counterpart, it must be the case that the genetically engineered food is substantially equivalent to its non-genetically engineered counterpart with respect to all characteristics relevant to the consumer. This is obviously a fallacious argument, and should not be used as the basis for avoiding more extensive testing and for avoiding the labeling of genetically engineered foods. Most critically, if characteristics important to food safety are not evaluated directly, the safety of consumers will be in jeopardy."
end of excerpt.

The truth of the matter is that the bacteria and viruses used to invade the fruit or vegetable in order to insert the DNA from another species makes the resulting organism unstable and unable to be assessed as substantially equivalent simply by its nature. Too little was known of the residual effects of these organisms when placed under all scenarios of environmental stress, horizontal gene transfer and pathogen movement by recombination or other factors which may change the metabolic protein content, which is said to be the main distinction regarding substantial equivalence. And in essence it was designed to be flexible to producers who could then tweak this concept to support whatever criteria fit their agenda, which was done regarding GMOs even though proper testing had not been performed to determine residual effects- effects we are now seeing played out across the globe:

"Establishment of substantial equivalence is not a safety assessment in itself, but a dynamic, analytical exercise in the assessment of the safety of a new food relative to an existing food. The comparison may be a simple task or be very lengthy depending upon the amount available knowledge and the nature of the food or food component under consideration. The reference characteristics for substantial equivalence comparisons need to be flexible and will change over time in accordance with the changing needs of processors and consumers and with experience." (Joint FAO/VMO Biotechnology and Food Safety Report, 1996, pp. 4 and 5)

This was the gift given to the biotech industry regarding transgenic foods. Substantial equivalence, which based on the lack of testing was neither substantial or equivalent, but surely profitable for those companies pushing it. However, as independent tests are being done we are seeing a far different picture in regards to this concept being applied.
From Physicians and Scientists for Responsible Application of Science and Technology

"This approval procedure based on "substantial equivalence" has been critisized and rejected by important bodies of scientists. This includes a/o the US National Academy of Science; its Canadian counterpart, the Royal society and the UK Medical Research Council. It has also recently been revealed that the US Food and Drug Administation (FDA), suppressed serious concerns about the safety of GE foods expressed by its own experts. Below just one example:

The Royal Society of Canada:
SE is not a scientific safety standard
"...substantial equivalence does not function as a scientific basis for the application of a safety standard, but rather as a decision procedure for facilitating the passage of new products, GE and non-GE, through the regulatory process, " -

The Royal Society of Canada (see footnote) (2001) Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, Ottawa, p.182 (April 2001).

We have been critisizing this approval procedure since several years and feel greatly satisfied to find that important bodies of scientists have joined us in rejecting it. It should be a matter of short time before the GE food approval regulations will be changed accordingly. This should inevitably lead to the withdrawal of all GE foods on the market as they were all approved on the basis of this flawed principle.

The paragraph above was written in year 2000 and yet this unscientific and dangerous approval procedure is still being used, although 10 years have passed, indicating that the governmental authorities dealing with approval are ignoring science in a seriously irresponsible way. This includes the FDA in the US, and the European Food Safety Agency, EFSA, of the European Union.

For more about the criticism by scientific bodies, see "Scientists and scientist organizations rejecting the principle of Substantial Equivalence". See also "How could this unreliable assessment method become established?" below.

Our recommendation

Foods that have been approved on the basis of the principle of Substantial Equivalence should be declared unsafe and be withdrawn from the market, see our Open letter to governments.

If it takes time to implement this, mandatory labeling is necessary for all GE foods and food containing GE components in order to facilitate early discovery of unexpected harmful effects.

Regulations for securing the safety of food should only be based on impartial scientific considerations. This has obviously not been the case in regulations applying the principle of substantial equivalence.

Measures need to be introduced in the regulatory procedures that prevent political interventions and exclude the influence from biased scientists and industrial lobbyists (see: A suggested procedure to ensure impartial safety assessment).

Without drastic improvements of the regulatory procedures, the health of the population of the Earth may be exposed to peril from insufficiently tested Novel foods that now are being developed and marketed."

In closing this then needs to be said. GMOS are dangerous in that we really do not know the true extent to which molecular changes can occur and how those changes can effect humans, animals, soil, and the whole of the natural world. Substantial equivalence is a farce in regards to GMOs and simply a mechanism employed to facilitate profit for corporate entities in the pockets of governments in order to control our food. It is an insidious invasion of our natural world and a abrogation of our right to food sovereignty.

In successive postings I will also be noting tests that conclude that there are differences between GMOs and conventional foods which were either deliberately overlooked in the approval process or simply not tested which then makes it a moral imperative that these organisms be labelled if not banned entirely. The safety of our children and the biodiversity of the world they will live in as well as ours depends on being aware of the machinations behind this attack on our food and environment.

This is a start:

Unintended changes in GM rice and maize

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