by Brandon Turbeville
February 2013

from BrandonTurbeville.Blogspot Website

 

 

 

Updated excerpts from,

Codex Alimentarius - The End of Health Freed
 

 

 

 

 

 

Part 1

February 4, 2013


 

Over the last two years, I have written extensively about the Codex Alimentarius guidelines and how they relate specifically to vitamin and mineral supplements, food irradiation, and the use of Recombinant Bovine Growth Hormone (rBGH).

I have also detailed the history and workings of the international organization as well as many of the current day to day manifestations of Codex guidelines as they appear in domestic policy.

However, there is yet another area in which Codex guidelines will play a major role in the development of food policy - namely, the proliferation of Genetically Modified Food.

The Codex committee that serves as the main battleground for the consideration of GM food is the Codex Committee on Food Labeling. This committee is extremely relevant due to the fact that it can effectively reduce the power of the consumer to virtually nothing if it decides not to force companies or countries to label their GM food, thus removing the ability of the consumer to boycott and/or avoid those products.

 

While it is well-known that public sentiment is unimportant to those at the top, governments and corporations tend to pay more attention when votes and sales reflect that sentiment. However, if Codex continues on its’ way to allowing unlabelled GM food onto the international market, the repercussions of consumer reaction will be entirely neutralized.

A brief discussion of the history of Codex in terms of GM food is necessary here to understand the direction that the organization is moving towards in regards to it.

For most of the seventeen years that Codex member countries have debated the safety of genetic modification of the food supply, the result has been little or no progress for one side or the other.

In 1993, at the behest of the Codex Commission, the CCFL agreed to begin working on the labeling aspect of GM food. Interestingly enough, the CCFL asked the United States, the country that was the most militant in its support of genetic modification, to develop a paper that would guide the committee’s discussion at the following session.

 

When this session arrived, there was a flurry of opinions tossed around from several different countries.

 

The most sensible position was that all GM foods should be labeled under any circumstances. Yet other countries, especially the pro-Gm ones, argued that labeling should only be required when there is the introduction of health or safety concerns, allergens, or when the food is significantly different from its traditional counterpart.[1]

 

This is a debate that largely continues until this day.

The concept of “substantial equivalence” versus “process-based” labeling has also become one of the most hotly contested issues within the Codex GM food labeling debate. Process-based labeling simply means that the driving factor behind the labeling guidelines is the process by which the food is created, grown, or otherwise produced.

 

Therefore, the qualifying factor for labeling GM food would be the process of genetic modification itself, forcing all GM food to be labeled as such. This is essentially the mandatory labeling of all GM food. When this concept was first introduced in 2001, it was supported by such countries as the European Union, India, and Norway.

 

Its staunchest opponents, of course, were the United States and Canada.[2]

 

Although this method of labeling standards was by far the most sensible if one were concerned about food safety and consumer rights of choice, it has been all but abandoned since the brief discussion at its introduction. The attention then has necessarily turned to the competing set of standards known as “substantial equivalence.”

“Substantial equivalence” guidelines are by far the most onerous means by which to label GM food outside of the scheme of voluntary labeling (such as what Canada has already pushed for).[3]

This set of standards not only provides loopholes through which GM food may enter the food supply, but also opens the door to total acceptance of GM food absolutely free of labeling. The idea behind the substantial equivalence labeling method is that the GM food will be compared to its conventional counterpart in terms of safety and composition.[4]

The food would then only require a label if it was found that there was a substantial difference between the GM product and the natural food or there were an introduction of a common allergen through the process of genetic modification.

 

While at first it may seem that there is a legitimate consideration of safety under these principles, such an impression is far from the truth.

Several problems exist with the concept of substantial equivalence. First, as is often the case with government and bureaucratic initiatives, the semantics of the term “substantial equivalence” leaves the door open to the possible acceptance of virtually all GM food.

 

While I will discuss this aspect further in future articles where the accepted Codex guidelines for testing GM food is mentioned, brief mention is still required early on in order to understand the dangers of the use of this labeling standard.

In order for a food to require labeling, it must do one of two things - introduce a new allergen or be significantly different from its “traditional counterpart.”[5]

 

The former requirement refers to the introduction of something along the lines of the peanut gene or the introduction of another common allergy to a food, thereby causing a potential allergic reaction to the food after consuming it.

 

However, there are thousands of food allergies besides peanuts. Codex itself admits in its GM food test protocol that the determination of what may be an allergy is a very difficult procedure.

 

It says,

“At present, there is no definitive test that can be relied upon to predict allergic response in humans to a newly expressed protein.”[6]

Although the guidelines go on to say that these potential allergens should be tested on a case-by-case basis, it is clear that the testing mechanisms being recommended are not necessarily geared for determining the potential allergenicity of newly introduced GM foods.

 

Especially on the scale that is needed to deal with the immense diversity of GM prototypes being introduced and the even greater variety of individual allergies that exist in the population.

It should also be noted that while there is some discussion of known allergens, there is no in-depth discussion of the very real possibility of new and previously unknown allergens being introduced due to the process of genetic modification. Indeed, the monitoring of the food once it enters the food chain is only occasionally mentioned throughout the Codex “Foods Derived From Modern Biotechnology” document and those mentions are vague and open-ended.[7]

 

So the question that follows is whether or not all of these potential allergens will be labeled as such, or if only the most common ones will be considered.

Second, the requirement that a food must be compared and found substantially equivalent to its “traditional counterpart” (natural food) is misleading as well. To begin with, one must ask the question of what exactly “substantial equivalence” means. Quite obviously, the term does not mean that the GM product must be identical.

 

This, in itself would negate the process of genetic modification.

Therefore, differences must necessarily be accepted. However, it is not at all clear just to what level these differences may exist and still be considered equivalent and/or safe. Nowhere is “substantial equivalence” clearly defined. The criterion for what is substantial and what is not is left completely open and subjective.

The closest thing there is to a definition is made by Nick Tomlinson of the UK Food Standards Agency in his report,

“Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology” where he references the 1996 expert consultation where substantial equivalence was defined as “being established by a demonstration that the characteristics assessed for the genetically modified organism, or the specific food product derived there from, are equivalent to the same characteristics of the conventional comparator.” [8]

Here again the term equivalence is used with the connotation that equivalent does not translate into identical or same.

 

Tomlinson makes this clear when he says:

The levels and variation for characteristics in the genetically modified organism must be within the natural range of variation for those characteristics considered in the comparator and be based upon an appropriate analysis of data.[9]

By not exactly being descriptive as to how wide a range this “natural range of variation” may be, it is apparent that substantial equivalence does not correlate to identical or even anything that would remotely be considered the “same.”

 

Indeed, the very nature of genetic modification precludes this as a possibility to begin with.

The concept of substantial equivalence is unfortunately the theory of labeling requirements adopted by Codex. It is also very similar to the criteria used in the United States and Canada.

As to be expected in such pro-GM countries as the United States, the GM labeling requirements are even less restrictive than those of Codex. For the most part, labeling of GM foods in the United States and Canada is completely voluntary.

This voluntary labeling scheme based on the concept of substantial equivalence is both a prime example of the weakness of both standards as well as a dark omen as to the direction of Codex guidelines as they continue to be developed.[10]
 

 

 


Sources

[1] MacKenzie, Anne. A. “The Process of Developing Labeling Standards For GM Foods In The Codex Alimentarius.” AgBioForum, Vol.3, Number 4, 2000. pp. 203-208. http://www.agbioforum.org/v3n4/v3n4a04-mackenzie.htm Accessed May 24, 2010.
[2] “Canadians Deserve To Know What They Are Eating: Food Safety Must Come Before Trade.” Canadian Health Coalition, Media Advisory, May 1-4, 2001. http://www.healthcoalition.ca/codex.html
[3] Ibid.
[4] “Safety aspects of genetically modified foods of plant origin, a joint FAO/WHO consultation on foods derived from biotechnology, Geneva, Switzerland 29 May - 2 June 2000”. World Health Organization. http://www.who.int/foodsafety/publications/biotech/ec_june2000/en/index.html
[5] MacKenzie, Anne. A. “The Process of Developing Labeling Standards For GM Foods In The Codex Alimentarius.” AgBioForum, Vol.3, Number 4, 2000. pp. 203-208. http://www.agbioforum.org/v3n4/v3n4a04-mackenzie.htm May 24, 2010.
[6] “Food Derived From Modern Biotechnology.” Codex Alimentarius 2nd Edition. P.20

[7] Ibid.
[8] Tomlinson, Nick. “Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology.” 2003. ftp://ftp.fao.org/es/esn/food/Bio-03.pdf Accessed May 24, 2010.
[9] Ibid.
[10] “Guidance For Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Biotengineering: Draft Guidance.” Food and Drug Administration. January 2001. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059098.htm



 

 

 

 

 

 

Part 2

February 6, 2013
 

 

In my last above article, I discussed the Codex Alimentarius position on the proliferation of Genetically Modified food in the world’s food supply - particularly the concept of substantial equivalence which uses circular and faulty logic in order to allow greater saturation of the food supply with genetically modified food.

“Substantial equivalence,” is an approach that seeks to approve the use and consumption of GM food based upon the idea that it is “substantially equivalent” to its traditional counterpart, thus, GM proponents claim, it is safe to consume and requires no extra labeling.

 

This approach to GM food is easily dismantled and I encourage the reader to access my article on the subject in order to understand the weaknesses and dangers of using the substantial equivalence model for GM food in any context.

The concept of substantial equivalence is unfortunately the theory of labeling requirements adopted by Codex. It is also very similar to the criteria used in the United States and Canada. As to be expected in such pro-GM countries as the United States, the GM labeling requirements are even less restrictive than those of Codex.

For the most part, labeling of GM foods in the United States and Canada is completely voluntary.

 

This voluntary labeling scheme based on the concept of substantial equivalence is both a prime example of the weakness of both standards, as well as a dark omen as to the direction of Codex guidelines as they continue to be developed.[1]

The FDA does not require GM foods to be labeled unless they meet one of four rather severe criteria. Even then, the labeling refers only to the issue at hand, not the process from which the food was created.

 

The criteria for labeling are as follows:

  1. If a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food.

  2. If an issue exists for the food or a constituent of the food regarding how the food is used or consequences of its use, a statement must be made on the label to describe the issue.

  3. If a bioengineered food has a significantly different nutritional property, its label must reflect the difference.

  4. If a new food includes an allergen that consumers would not expect to be present based on the name of the food, the presence of that allergen must be disclosed on the label.[2]

So, as these recommendations suggest, a GM food must only be labeled when it is so different from its “conventional counterpart” that it cannot even be considered the same food, is the cause of reactions or consequences that the natural version of it would not have caused, has a “significant” difference in nutritional composition, or if it introduces an allergen that would not otherwise have been present.

It should be noted, like the Codex guidelines for substantial equivalence mentioned earlier, that “significant” difference in nutritional composition is not clearly defined. So what some may consider to be truly significant might not even be considered worthy of any concern by the FDA, and certainly not by the manufacturing company.

Also, as mentioned earlier, there is no discussion of whether or not the inclusion of allergens to a food includes those less common allergies or just the most popular such as peanuts. Yet even meeting these criteria does not necessarily draw the label of “genetically modified” - merely a labeling of the potential side effects of consuming these foods.[3]

Only when one of these four criteria has been met must companies label their products in a manner that may suggest genetic modification and, even then, only in a subtle manner. In all other instances, however, the labeling is completely voluntary.

Just as disconcerting as voluntary labeling is the fact that the alleged “safety testing” is not even conducted by the FDA or any other regulatory agency, but by the food producers themselves. The FDA merely takes for granted the truth of whatever is provided them by industry. That is, if anything is provided to them at all.[4]

As stated in the federal register as far back as 1992, the FDA says,

FDA has traditionally encouraged producers of new food ingredients to consult with FDA when there is a question about an ingredient’s regulatory status, and firms routinely do so, even though such consultation is not legally required.[5]

It is certainly concerning to know that, at best, firms are encouraged to consult with the FDA but are not required to do so. Interestingly enough, this is not the position taken in regards to proven safe and effective natural and herbal supplements.

Adding to absurdity of the voluntary labeling policy held by the FDA, the regulatory agency works on the premise that GM foods are safe to begin with and that there is no difference between GM food and natural food.[6]

In the 1992 FDA Federal Register, the agency makes the claim,

In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food, such as proteins, fats and oils, and carbohydrates.[7]

Notice the similar terminology of “substantially similar” as compared with the “substantial equivalence” of Codex.

 

This adds even more credibility to the idea that the Codex model of GM food regulation is based on that used by the pro-GM FDA. Not only that, although the difference between the wording might seem unimportant to some, the term “similar” is even more open-ended than the Codex “equivalent.”

But how did the FDA come to these conclusions?

The agency admits that there is no premarket testing by the FDA itself; merely relying on industry to voluntarily consult with the FDA only when the industry feels there might be a problem with the product. [8]

Yet the agency still maintains, through basic assumption, that GM foods are not different from the natural versions. In the same Federal Register it says,

Under this policy, foods, such as fruits, vegetables, grains, and their byproducts, derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the act, FDA’s implementing regulations, and current practice, utilizing an approach identical in principle to that applied to foods developed by traditional plant breeding.

 

The regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components).

 

The method by which food is produced or developed may in some cases help to understand the safety or nutritional characteristics of the finished food.

 

However, the key factors in reviewing safety concerns should be the characteristics of the food product, rather than the fact that the new methods are used.[9]

The FDA here is claiming that the process of genetic modification, even though it has not evaluated it thoroughly, is not only safe but, for the most part, irrelevant to the question of food safety.

Of course, this is merely manufacturing conclusions out of thin air. The FDA asserts the safety of GM food because there is “substantial equivalence” between the two. However, there is “substantial equivalence” only because the FDA claims that this is the case. There is a massive lack of evidence to support any of these claims.

The FDA also claims that genetic engineering is no different from “traditional plant breeding,” an argument that is often made within the pro-GM community. Such is the belief (or argument) that traditional means of plant breeding such as grafting and cross-pollination are essentially the same as removal and insertion of DNA from one life form to another. In reality, nothing could be further from the truth.

This argument would be akin to claiming that breeding of humans of different ethnic backgrounds is the same as breeding between humans and horses. Additionally, the question of how the FDA would know this - since it has not conducted any scientific experiments regarding this claim - arises yet again.

 

Still, it continues to blend the two very different methods together by defining genetic engineering as the,

“alteration of the genotype of a plant using any technique, new or traditional.” [10]

Thus, the FDA puts the insertion of a pig gene into a tomato into the same category as natural birth, since genes change and develop with each generation.

 

If there were any doubt as to whether or not this is the FDA’s position their claim that “Most, if not all, cultivated food crops have been genetically modified,” should easily remove it. [11]

 

This claim is only true if one accepts the FDA’s definition of natural reproduction as genetic engineering.

As in most cases involving the FDA, the biotech food industry, and Codex Alimentarius, the boundaries of logic are not only pushed to the breaking point in order to justify and promote the proliferation of GM food, those boundaries are regularly crossed.

Indeed, these mental gymnastics used create an environment in which toxic GM food is virtually unregulated while healthy organic substances are annihilated by force and regulation are a feat in their own right.
 

 

 


Sources

[1] “Guidance For Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Biotengineering: Draft Guidance.” Food and Drug Administration. January 2001. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059098.htm
[2] Ibid.
[3] Ibid.
[4] “Statement of Food Policy - Foods Derived From New Plant Varieties,” FDA Federal Register Vol. 57. 1992. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Biotechnology/ucm096095.htm Accessed May 24, 2010.
[5] Ibid.
[6] Ibid.
[7] Ibid.
[8] Ibid. p. 5.
[9] Ibid p. 4.
[10] Ibid.
[11] Ibid.

 

 

 

 

 

 

 

Part 3

February 8, 2013
 

 

In my last above article, “Codex Alimentarius and GM Food Guidelines Pt. 2,” I wrote extensively about the position assumed by the FDA in regards to genetically modified food and the methodology used to assess its safety before it is released into the general food supply.

 

Needless to say, the FDA, which is notorious for its corruption and revolving door with Big Agricultural Corporations like Monsanto, takes an unbelievably hands-off approach to the regulation of GM food.

Yet, unfortunately, the approach taken by the FDA toward GM Food is only unbelievable if one expects the agency to apply science, logic, and reason to their decision-making process.

However, when one begins evaluating the FDA position on GM food in the context of the position held by Codex Alimentarius, one can easily see an agenda taking shape whose ultimate goal is the total proliferation of GM food the world over.

For instance, in the early 1990s, around the time the FDA was announcing its own policy toward GM food, the debate within Codex was heating up as well. Most of the arguments were taken up by the Codex Committee on Food Labeling (CCFL) and, for the most part, pitted the United States and Canada against the European Union, India, and Norway.

In 1996, because little could be agreed upon, the CCFL asked for guidance from the Codex Alimentarius Commission (CAC) on how labeling guidelines might be developed. In 1997 the CAC produced a document for that purpose.

 

These recommendations were that foods not “equivalent” to natural foods in nutritional value, intended use, or composition should be labeled.

Yet this was not accepted into Codex guidelines as,

  • Australia

  • New Zealand

  • Peru

  • Brazil

  • joined with Canada and the United States,

...in opposing these recommendations.

 

Definitions of terms also became an issue at the meeting.[1]

At the 27th CCFL session in 1999, it was decided that the Proposed Draft Recommendations for GM food labeling be reconsidered and rewritten. For this purpose, Codex created the Ad Hoc Working Group. Their stated mission was to more fully define “biotechnology-derived foods” and to revise the options considered for labeling between process-based and substantial equivalence methods.

 

The Working Group also agreed to consider establishing a maximum level of GM ingredients in a food as well as a minimum level for accidental inclusion of GM ingredients or food within a food.

As mentioned earlier, substantial equivalence has emerged as the most favored method of labeling within Codex, in an almost identical fashion to the FDA and Health Canada model.

Indeed, it is easily understood why this is the case when one takes a closer look at the Working Group developed to evaluate and rewrite labeling recommendations. While certain instances may seem harmless when viewed separately, when taken together they reveal a rather obvious attempt to stack the odds in favor of pro-GM sentiment by the CCFL.

First, Canada, perhaps the most pro-GM Codex member country besides the United States, was selected to chair the Group as well as coordinate the Group’s direction.

Also, a smaller Drafting Group was created under the Working Group to “hold the pen.” It was this group that would do much of the actual work in terms of hammering out the Recommendations document. However, five of the six countries represented in the Drafting Group were pro-GM countries.[2]

 

Clearly, it would be difficult for a non-favorable view of GM food to win out in a situation such as this.

In 2000, an attempt was made by the CCFL to direct the Working Group to streamline the two different methods of labeling (process-based and substantial equivalence) into a Codex Guideline as well as other key issues involving GM food labeling. A document of this nature was subsequently produced by the United States. Yet, despite the packing of the Drafting and Working Groups, the CCFL was still unable to approve the guidelines that the groups produced.

However, the Committee was able to approve the use of three definitions related to GM food.[3]

 

They are as follows:

  1. Food and food ingredients obtained through certain techniques of genetic modification/genetic engineering - food and food ingredients composed of or containing genetically modified/engineered organisms obtained through modern biotechnology, or food and food ingredients produced from, but not containing genetically modified/engineered organisms obtained through modern biotechnology.

  2. Genetically modified/engineered organism - an organism in which the genetic material has been changed through modern biotechnology in a way that does not occur naturally by multiplication and/or natural recombination.

  3. Modern Biotechnology - the application of:

  1. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and the direct injection of nucleic acid into cells or organelles

  2. Fusion of cells beyond the taxonomic family, that overcome natural physiological, reproductive, or recombination barriers and that are not techniques used in traditional breeding and selection.[4]

When one looks at the definitions agreed upon at the 29th session of Codex, it can be seen that there is a move toward using the term “modern biotechnology” in place of “genetic engineering/modification.”

 

This is largely an attempt to use semantics in an effort to reduce, through ignorance, the apprehension of the public to the consumption of GMO’s.

However, in the face of such controversy, in 2003 Codex did produce and approve a set of Guidelines for the assessment of the safety of GM food. Entitled “Codex Principles and Guidelines On Foods Derived From Biotechnology,” the Guidelines do not deal with labeling concerns at all, but with the standards for the science used to assess these foods for safety.

The “Codex Principles and Guidelines On Foods Derived From Biotechnology” is made up of four sections, two of which deal with GM plants while the other sections deal with GM organisms in general and GM animals respectively.

 

Similar to the “Guidelines for Vitamins and Mineral Supplements,” these guidelines are not only unscientific but carefully crafted to allow the approval of dangerous GM foods. The game, in essence, is clearly rigged.

When looking at the first section of the guidelines one is able to see a very real correlation to those designated for vitamins and minerals. Using a form of risk analysis to determine the safety of GM food, Codex seeks to explain the reason for its choice of methodology.

 

It states,

While risk analysis has been used over a long period of time to address chemical hazards (e.g. residues of pesticides, contaminants, food additives and processing aids), and it is being increasingly used to address microbiological hazards and nutritional factors, the principles were not elaborated specifically for whole foods.[5]

This is an interesting statement considering the fact that risk analysis was indeed considered adequate for the safety examination of vitamins, minerals, and nutritional supplements. However, for whole foods, GM foods in particular, Codex has decided that risk analysis is not appropriate.

The very next section of the Introduction admits that while risk analysis can in fact be applied to foods (including GM food) “in general terms”,

“it is recognized that this approach must be modified when applied to a whole food rather than to a discrete hazard that may be present in food.”[6]

One can gain an understanding of how the process is adapted to suit the needs of Codex by reading through the guidelines as a whole.

 

However, suffice it to say that this modification is generally the removal of all standards and qualifications that might illuminate the vast amount of safety concerns present within GM foods.[7]

Another disturbing statement made in the introduction to the document casts even more doubt upon the scientific validity of Codex’s guidelines.

 

The Guidelines state,

Where appropriate, the results of a risk assessment undertaken by other regulatory authorities may be used to assist in the risk analysis and avoid duplication of work.[8]

While on its face, this statement appears only to be a call for labor efficiency, at its best it assumes the objectivity of the regulatory authorities doing the testing.

 

However, what is most concerning about this policy is that risk assessment “conclusions” reached by regulatory agencies such as the FDA and Health Canada may be accepted in place of an independent examination.

Truthfully, the likelihood of a legitimately independent assessment made possible by Codex is almost nonexistent.

 

However, in the case of GMO’s, the odds are even less so for the FDA and Health Canada, two agencies that have been largely bought and paid for by Monsanto and other large agri-business corporations. Indeed, as far as GM foods go, the FDA assessments have largely been completed since the time that the agency has claimed that there is no difference between genetic modification and traditional plant breeding.[9]

 

This agency has also made it clear that safety testing is to be conducted by the manufacturer of the product rather than the agency itself, relying solely on the company’s scientific and moral standards.

 

In effect, as mentioned earlier, the science determining the safety of GM foods comes straight from the manufacturer itself.[10]

With this in mind, one can clearly see that the same line of ascension exists in Codex Alimentarius. If Codex is willing to accept the safety assessments of regulatory agencies without independent testing of its own and regulatory agencies are willing to accept the safety assessments of corporations without independent testing of their own, then Codex is willing to accept the safety assessments of corporations without independent safety testing of their own.

 

Indeed, this syllogism adequately reflects the reality of the relationship between Codex, corporations, and the future of GM foods.

Another issue of great concern is the definition of “conventional counterpart.” Because Codex uses the concept of substantial equivalence[11], this seemingly requires that the GM product be compared to its natural counterpart.

However, the definition of conventional counterpart, according to Codex, is,

“a related organism/variety, its components and/or products for which there is experience of establishing safety based on common use as food.”[12]

This definition poses a potential problem because it does not make clear (in the body of the text) that the conventional counterpart must be the natural version of the food. In a footnote, the statement is made that,

“It is recognized that, for the foreseeable future, foods derived from modern biotechnology will not be used as conventional counterparts.” [13]

The phrase, “for the foreseeable future” raises its own difficulties, because it provides a potential loophole.

 

“Foreseeable future” does not set a timeline for the current policy to run out, but it does leave open the possibility of allowing a change in the current practice.

Allowing GM products to be compared to other GM products for substantial equivalence is an enormous blow to the environment, human health, and consumer choice. Such an action would completely undercut the already weak and ridiculous method of substantial equivalence and would turn the entire nature of our food supply upside down.

 

One would be comparing a dangerous product to another dangerous product but labeling it safe because it was substantially equivalent to the first dangerous product.

Like the situation involving vitamins and minerals, this is the Twilight Zone reality produced by Codex once it gains power of the food supply.
 

 

 


Sources

[1] MacKenzie, Anne. A. “The Process of Developing Labeling Standards For GM Foods In The Codex Alimentarius.” AgBioForum, Vol.3, Number 4, 2000. pp. 203-208. http://www.agbioforum.org/v3n4/v3n4a04-mackenzie.htm May 24, 2010.
[2] Ibid.
Please Note:
While it is true that the European Union had two representatives on the panel, it also true that the EU speaks with one voice. Even if one were to argue that this would give them extra representation, pro-GM nations still outnumber anti-GM nations.
[3] MacKenzie, Anne. A. “The Process of Developing Labeling Standards For GM Foods In The Codex Alimentarius.” AgBioForum, Vol.3, Number 4, 2000. pp. 203-208. http://www.agbioforum.org/v3n4/v3n4a04-mackenzie.htm May 24, 2010.
[4] Ibid.
[5] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P.1
[6] Ibid.
[7] Ibid.
[8] Ibid.
[9] “Statement of Food Policy - Foods Derived From New Plant Varieties,” FDA Federal Register Vol. 57. 1992. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Biotechnology/ucm096095.htm Accessed May 24, 2010.
[10] Ibid.
[11] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P. 9
[12] Ibid. p.2
[13] Ibid.

 

 

 

 

 

 

 

Part 4

February 11, 2013



In my last above article regarding Codex Alimentarius Guidelines on Genetically Modified food, I discussed the dangerous concept used by both the international organization and the U.S. Food and Drug Administration (FDA) known as substantial equivalence/substantial similarity and how this method of comparison and evaluation can and is being used to further the proliferation of GM food in the world’s food supply.

In discussing the method used to evaluate the safety of GM food, I wrote,

If Codex is willing to accept the safety assessments of regulatory agencies without independent testing of its own and regulatory agencies are willing to accept the safety assessments of corporations without independent testing of their own, then Codex is willing to accept the safety assessments of corporations without independent safety testing of their own.

 

Indeed, this syllogism adequately reflects the reality of the relationship between Codex, corporations, and the future of GM foods.

Furthermore, in regards to the “substantial equivalence” methodology mentioned above, I concluded the article by stating,

Allowing GM products to be compared to other GM products for substantial equivalence is an enormous blow to the environment, human health, and consumer choice.

 

Such an action would completely undercut the already weak and ridiculous method of substantial equivalence and would turn the entire nature of our food supply upside down.

 

One would be comparing a dangerous product to another dangerous product but labeling it safe because it was substantially equivalent to the first dangerous product.

Like the situation involving vitamins and minerals, this is the Twilight Zone reality produced by Codex once it gains power of the food supply.

Unfortunately, this potential concern is now an imminent one because Monsanto has in fact submitted an application for a GM corn called LY038. In its submission for approval, Monsanto provided the regulators’ assessing the product with information comparing LY038 with another GM corn product called LY038 (-), another GM corn product.[1]

True to form, in many of the pro-GM countries such as New Zealand, Australia, Japan, Canada, the Philippines, and South Korea, the LY038 corn was approved based upon the method of using a GM corn as a conventional counterpart.[2]

 

The United States, being the most open to GM food, and only requiring voluntary submission, has also approved LY038 for cultivation.[3]

Thankfully, the Monsanto agenda stalled in the European Union, and in 2009 Monsanto withdrew its application for the product in Europe.[4] This is largely due to a small group of relatively independent scientists from the Centre for Integrated Research in Biosafety (INBI) out of New Zealand who brought out many risks evident from a close reading of the Monsanto application dossiers.

As a result of their work, the European Food Safety Authority (EFSA) requested additional research and safety data. That was all that was needed in order to cause Monsanto to withdraw its application for LY038 use in Europe.[5]

Monsanto claimed that the reason for the removal of its submission purely economical and that,

“although our preference would have been to complete the EU approval of LY038, conducting further studies, as requested [by the EFSA GMO Panel], can no longer be justified, in view of the additional costs involved and the reduced commercial interest in this product.” [6]

However, those who are aware of Monsanto’s track record have a different take. In a statement made to Biosafety Information Centre, Prof. Jack Heinemann, who led the INBI research team, summed up the situation succinctly.

I personally don’t believe that the withdrawal of LY038 from commercialization was a budget blow-out. Monsanto estimated that the street-value of LY038 was going to be US $1 billion/year.

 

People are still feeding corn to cows, chickens and pigs and corn is still being converted to biofuel in the US. The price of corn is at historical highs and is not expected to decrease. Do we really believe that a market of $1 billion/year is too small for Monsanto? I don’t... The major issue raise by EFSA was Monsanto’s use of another GM product as a control in all its safety studies.

 

This violates both international food safety testing guidelines and European rules. INBI was the first in the world to point this out. FSANZ [Food Standards Australia New Zealand] ignored it. EFSA didn’t. Monsanto pulled the product.

 

We estimate that upwards of US $1 billion had already been invested and if it were just a matter of demonstrating that a safe product was safe, then a few tidy up scientific studies would have cost nothing in comparison.[7]

The obvious reason that the application was pulled, at least according to this writer and, seemingly, Prof. Heinemann, is that Monsanto’s LY038 was absolutely unsafe for consumption and that it would never have stood up to any scientific safety testing.

 

It is also likely that the company’s own research data would have proven its danger since it would not even submit the requested material to EFSA. In conjunction with this, Monsanto may have been afraid that exposure of this fact would have crippled its progress with the countries that did approve LY038.

However, while it did not succeed with the EU (this time), the precedent has been set for using a GM product as a conventional counterpart.

This will undoubtedly affect Codex guidelines in the future, especially considering the fact that so many and such major players have accepted these standards of testing. Indeed, it will undoubtedly set a dangerous precedent for the evaluation of the safety of GM food the world over.
 

 

 


 
Notes

[1] “New Attack on GM Food Safety Testing Standards,” Centre for Integrated Research in Biosafety, University of Canterbury. February 2007. http://www.sustainabilitynz.org/docs/Backgrounder_NewAttackonGMFoodSafetyStandards.pdf Accessed May 24, 2010.
[2] “Monsanto pulls GM corn amid serious food safety concerns,” GM Free CYMRU. http://gmfreecymru.org/Press_Notice9Nov2009.htm
[3] “Transgenic high-lysine corn LY038 withdrawn after EU raises safety questions,” The Bioscience Resource Project, Nov. 10, 2009. http://www.bioscienceresource.org/news/article.php?id=43 Accessed May 24, 2010.
[4] “Europe balks at GE corn in NZ,” Stuff.co.nz, Feb. 11, 2009. http://www.stuff.co.nz/national/3020246/Europe-balks-at-GE-corn-in-NZ
[5] “Monsanto pulls GM corn amid serious food safety concerns,” GM Free CYMRU. http://gmfreecymru.org/Press_Notice9Nov2009.htm
[6] “What has happened to high lysine corn?” Biosafety Information Centre. http://www.biosafety-info.net/bioart.php?bid=583&ac=st
[7] Ibid.

 

 

 

 

 

 

 

Part 5

February 15, 2013

 

 

In my last article, “Codex Alimentarius and GM Food Guidelines Pt.4,” I discussed a tangible, real-world example of the results of using “substantial equivalence” or “substantial similarity” when assessing the dangers of Genetically Modified (GM) food and/or approving that food for the market.
 

Returning to the defining Codex document in relation to GM food, “Food Derived From Modern Biotechnology,” it should be noted that the risks associated with GMOs are dealt with in a rather curious manner.

 

Indeed, the monitoring and management of risks from GM food after their approval is mentioned rather blandly in the introductory section of the Guidelines.

 

It says,
 

Post market-monitoring may be undertaken for the purpose of:

A) Verifying conclusions about the absence or the possible occurrence, impact and significance of potential consumer health effects; and

B) Monitoring changes in nutrient intake levels, associated with the introduction of foods likely to alter nutritional status significantly, to determine their human health impact. [1]

It should be noted that these are issues which should be resolved in a scientific setting prior to market.

 

Yet Codex is obviously content to allow the public to act as lab rats in the real world rather than force these side effects to be addressed in an actual lab. Absolute disregard for the global population is evident here.


As will be discussed in future articles, when one understands the ultimate purpose of Codex Alimentarius, it becomes clear as to why policies like this emanate from the organization. Such is also the case when Codex mentions the management of risks finding their way into the market and the need for post-market tracing for the purpose of recall.[2]

 

It is important to note that tracing food materials is a difficult task, especially if those products have already found their way into the environment and have begun to reproduce.
 

Regardless, the second chapter of Codex’s “Foods Derived From Modern Biotechnology” makes what should be considered a revelatory admission. It says,

The Codex principles of risk analysis, particularly those for risk assessment, are primarily intended to apply to discrete chemical entities, such as food additives and pesticide residues, or a specific chemical or microbial contaminant that have identifiable hazards and risks; they are not intended to apply to whole foods as such.[3]

Essentially, this is an admission that risk assessment methodology is absolutely incapable and inappropriate when dealing with the safety of a whole food.

 

As Codex makes clear, the principles for risk assessment were never intended to address anything other than chemicals and additives.

However, one should remember that risk assessment is indeed the method used to determine the safety of vitamins, nutrients, and minerals by Codex Alimentarius in order to label them unsafe at unreasonably low levels.

But Codex continues with even further admission that the testing methods used are not nearly as intense as one might think.

 

The document reads,

Traditionally, new varieties of food plants have not been systematically subjected to extensive chemical, toxicological or nutritional evaluation prior to marketing, with the exception of foods for specific groups, such as infants, where the food may constitute a substantial portion of the diet.

 

Thus, new varieties of corn, soybean, potatoes and other common food plants are evaluated by breeders for agronomic and phenotypic characteristics, but generally, foods derived from such new plant varieties are not subjected to the rigorous and extensive food safety testing procedures, including studies in animals, that are typical of chemicals, such as food additives or pesticide residues, that may be present in food.[4]

Simply put, Codex is admitting, albeit cleverly, that the testing method for whole foods is inadequate, and that the testing itself is not nearly as extensive as it would be for evaluating a known toxin like a chemical, pesticide, or apparently, vitamins and minerals.

As related to Codex’s position on vitamins and minerals, Codex considers genetically modified foods that have been engineered to produce a deadly chemical or pesticide to be a whole food, but vitamin C is considered a toxin.

Yet Codex does not stop here with the prefacing of their intended deceit and the admission of flawed and manipulated science.

 

It says,

Animal studies cannot be readily applied to testing the risks associated with whole foods, which are complex mixtures of compounds, often characterized by a wide variation in composition and nutritional value.

 

Owing to their bulk and effect on satiety, they can usually only be fed to animals at low multiples of the amounts that might be present in the human diet.

 

In addition, a key factor to consider in conducting animal studies on foods is the nutritional value and balance of the diets used; this is in order to avoid the induction of adverse effects that are not related directly to the material itself.

 

Detecting any potential adverse effects and relating these conclusively to an individual characteristic of the food can, therefore, be extremely difficult. If the characterization of the food indicates that the available data are insufficient for a thorough safety assessment, properly designed animal studies could be requested on the whole foods.

 

Another consideration in deciding the need for animal studies is whether it is appropriate to subject experimental animals to such a study if it is unlikely to give rise to meaningful information.[5]

But there are several problems with this statement.

First, let it be made clear that this writer does not support the use of animals for laboratory testing for any reason.

However, this issue is not the focus of this article and it will be repeatedly referred to in its proper context in terms of scientific debate.

That being said, what Codex has admitted to in this statement, albeit subtly, is that test subjects will actually be fed significantly less of the GM food in question than exists in the standard human diet.

 

Nowhere does Codex mention that the amount fed to the test subjects can be adjusted per capita, but simply that the amount fed to them will be,

“at low multiples of the amounts that might be present in the human diet.” [6]

Furthermore, Codex attempts to convince the reader that because of differences in nutritional values and diet balance in the animals being tested it is extremely difficult to determine if there are any adverse effects resulting from the material being tested or another material/condition. Hence, Codex would have the reader believe that this problem could not be solved by the addition of a control group.

In the end, the overall conclusion of Codex is that testing GM foods is largely unproductive and that, for the most part, it should only be conducted in very special circumstances. Mere post-market tracking is looked upon as the most favorable route.

 

This, however, leaves the consumer as the test subject, and corrective action can only be taken after it is too late for hundreds, thousands, or even millions of people.

Codex furthers this claim with an admission of its acceptance of “substantial equivalence” as a testing standard.

 

Because of the problems associated with using risk assessment to address dangers in whole foods (but evidently not nutrients and vitamins), Codex claims it must rely on substantial equivalence to address intended and unintended changes in the food. Hence, Codex officially accepts the concept. [7]

In subsequent sections, Codex claims that even weak standards like substantial equivalence may not be required.

 

The guidelines state,

“For the reasons described in Section 3, conventional toxicology studies may not be considered necessary where the substance or a closely related substance has, taking into account its function and exposure, been consumed safely in food.” [8]

However, there is no discussion of exactly how it will be determined that these substances have been consumed safely in food to begin with.

 

Considering the fact that toxic substances like fluoride and rBGH have been consumed “safely” in food for many years, it is certainly frightening to think that even more substances may be created and added to the food supply under the guise of a history of safe consumption.

 

Nevertheless, this process (or lack thereof) is not only unscientific, it is very dangerous.


Although Codex clearly maintains a double standard in regards to GM food versus vitamins and nutrients, there are some similarities in the risk assessment procedure applied to them. One of the few instances in which Codex applies the same standards for GM food as for dietary supplements is the area of nutritional properties of the food.

In fact, this procedure is in direct correlation to the Guidelines for Vitamin and Mineral Food Supplements and works in tandem with them in order to create a lower acceptable level of nutrients in the food itself.

In relation to this situation, it is important to pay close attention to several statements made within the guidelines.

 

For instance,
 

Information about the known patterns of use and consumption of a food, and its derivatives should be used to estimate the likely intake of the food derived from the recombinant-DNA plant.

 

The expected intake of the food should be used to assess the nutritional implications of the altered nutrient profile both at customary and maximal levels of consumption.

 

Basing the estimate on the highest likely consumption provides assurance that the potential for any undesirable nutritional effects will be detected. [9]

While this language is carefully crafted to appear benign and concerned only with the welfare of different cultures consuming the GM food, what is actually being presented is the idea of a Global Expectable Average Daily Diet for purposes of creating an Upper Limit not on GM food, but on the nutrients existing within the food itself - all this, while, at the same time, allowing genetically engineered food to remain virtually unregulated.

As mentioned in the chapter dealing with vitamin and mineral supplements, the Global Average Daily Diet is simply taking the “average” level of consumption of a food or nutrient across the world and using that level as a base level standard for what will be considered the average intake of the product by all populations. The highest or lowest levels are usually chosen based on the needs of the scientist, particularly in situations like these where researchers have ulterior motives.

Remember, in the case of vitamin and mineral food supplements where the highest level of intake was used instead of the real average. This was because third world countries were not included properly in the average.

Like the GADD for vitamins and nutrients, the highest level of consumption will be used to examine GM food. However, using the highest level of consumption, in this case, will have an entirely different effect than it did upon vitamins and minerals.

Using the highest level of consumption estimation in concert with the concept of substantial equivalence, Codex creates an environment where it would be difficult for GM food not to be approved.

With the concept of substantial equivalence and the GADD taken in concert with one another, we could easily imagine a hypothetical scenario such as the following:

We might imagine that potatoes have a higher consumption rate in North America and Europe than in other regions of the world. So researchers would determine, based on the rate of potato consumption of Europe and North America, the Global Expectable Average Daily Diet.

 

This average consumption rate would be applied worldwide regardless of other cultures’ consumption of potatoes. Likewise, using the concept of substantial equivalence, GM potatoes would be approved with an Upper Limit of the highest rate of consumption worldwide.

Thus, substantial equivalence and the GADD are two pieces of the puzzle used to craft a system of regulations in which vitamins and mineral supplements are severely restricted in terms of levels of nutrition, while GM food remains virtually unregulated at all.


In future articles, I intend to expand upon the possibilities of these concepts to be used to form a regulatory structure in which nutrition itself is regulated even out of food and where the genetically modified version is the only acceptable product.

 

 

 

 

Notes

 

[1] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P. 4 
[2] Ibid. p.4
[3] Ibid P. 7
[4] Ibid. p.8
[5] Ibid. p.9
[6] Ibid. p.9
[7] Ibid. p.9
[8] Ibid. p. 14
[9] Ibid. p.17

 

 

 

 

 

 

 

 

Part 6

February 18, 2013

 

 

Over the last few weeks, I have written a number of articles dealing with the dangers of the methods of analyzing the risks of Genetically Modified (GM) food used by both Codex Alimentarius and the FDA known as “substantial equivalence/substantial similarity” and the “risk assessment methodology used in the evaluation process.

 

In conjunction with the Codex document “Foods Derived From Modern Biotechnology,” the Codex position on the evaluation and labeling of GM food, I described the hypocrisy of Codex’s position towards vitamin and mineral supplements and its position in regards to GM food which is, interestingly enough, one hundred and eighty degrees different.


 

However, there are even more dangers to using the “substantial equivalence/substantial similarity” model in conjunction with the “risk assessment” evaluation methodology in terms of GM food.


Indeed, there exists a very real possibility that the Codex position on GM food as well as vitamin and mineral supplements will be used to develop a food system in which GM food is the only acceptable form of food allowed in the supply, while any other food may be removed from the market.

 

In addition, it is entirely possible that once the standards are set by Codex and agreed upon by nations participating in the WTO, that foods containing high levels (or reasonable levels) of nutrition could be removed from the market simply on the basis of their high nutritional content.


For instance, the damage to the food supply does not end with the introduction of GM foods. In addition, because Codex standards are enforced by the WTO, the Maximum Permitted Levels for vitamin and minerals developed by Codex will remain in place.

So, because the risk assessment for GM food based on “substantial equivalence” will inevitably determine the GM food itself to be safe, the problem then becomes the nutritional value within the food.

The nutrition then becomes the enemy and must be removed.


While this might seem both improbable and impossible, it is, in fact, neither.

The seeming improbability of a Codex declaration of nutrients as toxins has already been realized and the genetic manipulation of the nutritional properties of food is not an impossibility at all.

While the cover story for the introduction of GM food often involves the alleged wish to bring about the end of malnutrition by increasing nutritional properties of the food genetically (a blatant contradiction if one accepts that nutrients should be treated as toxins), the ability to decrease nutrition through genetic modification is just as realistic.

We then have a situation where nutritionally deficient GM food is not only allowed, but required due to the “dangerous” amount of vitamins and minerals that exist in the natural food.

 

Codex even admits later on in the Guidelines that nutrients will be focused on rather than the dangers of the GM food.

 

It says,

To assess the safety of a food derived from a recombinant-DNA plant modified for a nutritional or health benefit, the estimated intake of the nutrient or related substance in the population(s) is compared with the nutritional or toxicological reference values, such as upper levels of intake, acceptable daily intakes (ADIs) for that nutrient or related substance.[1]

The question then is not the safety of the GM food, but of the amount of vitamins and nutrients included in it.

Continuing through the Guidelines, such a statement is cleverly made.

 

It says,

“Rather than trying to identify every hazard associated with a particular food, the intention of a safety assessment of food derived from recombinant-DNA is the identification of new or altered hazards relative to the conventional counterpart.” [2]

Not only is this an extremely limiting set of standards for assessing the safety of the product, what is actually meant by “hazard”, although not explicitly stated, is nutrients.

This is made even clearer in the next paragraph which states,

“Upper levels of intake for many nutrients that have been set out by some national, regional and international bodies may be considered, as appropriate. The basis for their derivation should also be considered in order to assess the public health implications of exceeding these levels.” [3]

Clearly, nutrients are the focus of much of the risk assessment methods applied to GM food.

This may initially cause some GM food products to be rejected by Codex due to the higher level of nutritional properties being produced. That is, until the food is modified once again to have a lower nutritional value. When seen in this light, it becomes obvious that many of the Codex Guidelines are intertwined with one another.

 

However, none are more important than those related to vitamins, minerals, and nutrients.

Returning to the Codex Guidelines themselves, the organization leaves itself yet another loophole by claiming that, in a situation where even the unbelievably weak “substantial equivalence” method cannot allow the approval of a GM food, that the food used as a conventional counterpart may be changed in order to suit the GM product which is being evaluated.

 

It says,

When the modification results in a food product, such as vegetable oil, with a composition that is significantly different from its conventional counterpart, it may be appropriate to use additional conventional foods or food components (i.e. foods or food components whose nutritional composition is closer to that of the food derived from recombinant-DNA plant) as appropriate comparators to assess the nutritional impact of the food.[4]

In this statement Codex is openly admitting that it will simply change the “scientific” process that we are supposed to put our faith in, in order to accommodate the GM substance being tested.

 

Essentially, Codex is saying,

“If the conventional counterpart is not substantially equivalent, change the conventional counterpart to one that is.”

Clearly, inasmuch as Codex guidelines are accepted, Codex is exercising control over the food supply and the choice that every human being has a right to make on their own.

 

Unfortunately, it is a very real possibility that if Codex Alimentarius is not stopped, we will live in a much smaller world where starvation, sickness, and hunger are rampant and where we must beg our multinational corporate masters for a bite of the toxic mass that we will have no choice but to eat.

 

 


Sources

[1] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P.27
[2] Ibid. p.25
[3] Ibid.
[4] Ibid. p.17

 

 

 

 

 

 

 

Part 7

February 20, 2013

 

 

In several of my recent articles, I have discussed the problems of using “risk assessment” methodology in the evaluation of both vitamin and mineral supplements and Genetically Modified (GM) food.

 

I have also discussed at length the dangers of the Codex Alimentarius and U.S. Food and Drug Administration position on GM food which is known as “substantial equivalence” and, in its more extreme forms, “substantial similarity.”

However, another concern addressed by the Codex Guidelines has to deal with antibiotic resistance created through the process of genetic engineering. Yet, as is typical of any Codex Alimentarius presentation, the agency makes several misleading and unsettling statements in this regard as well.

 

While Codex does state that methods should be used that do not result in antibiotic resistance, it qualifies that claim in its document “Foods Derived From Modern Biotechnology,” by stating that these methods should be used,

“where such technologies are available and demonstrated to be safe.” [1]

This is certainly no mandate. It is merely a suggestion that will most likely be completely ignored by industry.

The Guidelines then go on to say that,

“Gene transfer from plants and their food products to gut micro-organisms or human cells is considered a rare possibility because of the many complex and unlikely events that would need to occur consecutively.” [2]

This statement stands in direct contradiction to established science.[3]

 

Indeed, the series of events that would have to transpire in order for the transfer of modified genes from a plant to human DNA or cells are neither unlikely nor rare.

 

In a footnote to this statement, Codex makes the claim,

“In cases where there are high levels of naturally occurring bacteria that are resistant to the antibiotic, the likelihood of such bacteria transferring the resistance to other bacteria will be orders of magnitude higher than the likelihood of transfer between ingested foods and bacteria.” [4]

Yet while this may in fact be true the statement is still misleading.

 

The issue being discussed in the footnoted statement is the likelihood of DNA transfer from GM plants to humans. Furthermore, if such events were so unlikely, why would it be important not to use antibiotic resistant gene technology in the future?

Another concern presented in the section of “Foods Derived From Moderin Biotechnology” dealing with GM plants is the question of potential allergens being created within the food products as well as the introduction of entirely new allergens that have never before existed in nature.

While Codex claims that “all newly expressed proteins” as well as “a protein new to the food supply” should be tested for safety, there are legitimate questions as to whether or not Codex has the ability or the desire to test for such possibilities. [5]

First, while it is quite possible to know what foods occurring naturally are allergenic, it is much more difficult to come to these conclusions about new substances or proteins.

 

This is partly due to the fact that naturally occurring materials have so many millions of years of history and use which, in itself, tends to naturally weed out the allergenic foods from the non-allergenic ones in a population’s diet. GM products do not have this history.

Indeed, the idea that over time a population tends to form its own guidelines through natural process adds to the ease in which scientific inquiry may form knowledge of the food properties in relation to the population itself. Again, this is not the case with GM food.

Therefore, another problem with the Codex Guidelines is made manifest. Because Codex works on a global scale, the potential allergens are listed globally and may not take into consideration (in future labeling) the geographic concerns of individual populations.

 

When one considers the fact that allergens differ across geographic boundaries, with some foods being allergenic in one culture but not in others, he/she is confronted with the task that, in order to introduce a new substance into the food supply with new proteins, all of these populations must be tested separately.

 

The tests of course should also be conducted over a longer period of time to investigate prolonged exposure.

However, Codex makes no mention of this problem and, likewise, mentions no remedy for it.

 

Are we really supposed to believe that, hidden deep within the Guidelines, Codex plans to organize representative samples of every culture across the globe for every new protein added to the food supply? This is not likely even if one believed the organization was working truly promoting food safety.

Secondly, Codex itself admits tremendous flaws in its ability to test for new allergens.

 

It says quite plainly that,

“there is no definitive test that can be relied upon to predict allergic response in humans to a newly expressed protein.” [6]

Because of this lack of a standardized and easily deciphered test, it goes on to say,

“A critical issue for testing will be the availability of human sera from sufficient numbers of individuals.” [7]

This, however, is a major problem due to the fact that in order to test for just one allergy a minimum of eight sera is required for a major allergy, and a minimum of twenty-four sera for a minor allergy.[8]

This is a rather large amount of material for testing purposes. It should be noted that this is the required sera for just one test subject. This test would have to be repeated hundreds and perhaps even thousands of times per geographic region or culture. It would then have to be replicated hundreds or thousands of times more on a global scale to account for these regions and cultures.

Even Codex admits, albeit in a footnote, that,

“It is recognized that these quantities of sera may not be available for testing purposes.” [9]

With this in mind, it is clear that testing for allergens in GM products would prove extremely difficult to organize and conduct, even if Codex were truly committed to its professed goal of food safety.

 

 

 

 

Notes

[1] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P.18
[2] Ibid. p.18
[3] Ho, Mae-Wan; Ryan, Angela; Cummins, Joe; “Cauliflower Mosiac Viral Promoter- A Recipe For Disaster?” Institute of Science in Society. 
[4] Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P.18
[5] Ibid. p. 27
[6] Ibid. P.20
[7] Ibid.
[8] Ibid.
[9] Ibid. p.22

 

 

 

 

 

 

 

Part 8

February 22, 2013

 

 

In the course of the recent article series I have written regarding Codex Alimentarius and its position on Genetically Modified (GM) food, I have criticized both the “risk assessment” method of GM food evaluation as well as the official position of Codex Alimentarius in regards to the “substantial equivalence” standards.

 

I have also written about the very real possibility of the introduction of new allergens and antibiotic resistant bacteria into the general food supply.

However, up to this point, all of the problems with the Codex Guidelines mentioned have been in relation to the section of the Codex GM position document known as “Foods Derived From Modern Biotechnology,” which focuses on GM plants.

There are, accordingly, two more sections - one dealing with GM Micro-Organisms and the other dealing with GM animals.

However, while it may seem that the majority of criticism expressed thus far focuses more attention on the first section (GM plants), the fact is that all three sections are very similar in their language and directives, with only a few changes in the wording made to apply to the new topic.


In many of these sections the language is word for word, copied and pasted to reiterate the same purpose as the first section. Therefore, I will not repeat my criticisms of the second and third sections that have appeared in my criticism of the GM Plants section.

 

Suffice to say that all of the problems existing in the GM Plant section exist in the GM Micro-Organism and GM Animal sections as well, namely those of questionable scientific practices, the ignoring of relevant data, and so on. This claim is easily verifiable by reading the Guidelines document cited in the footnotes.

With that said, some attention should be paid to the section entitled, “Guideline For The Conduct Of Food Safety Assessment Of Foods Produced Using Recombinant-DNA Micro-Organisms.”

 

This section deals mainly with bacteria, yeasts, and certain types of fungi in their uses in food production.

While making many of the same admissions present in the GM plant Guidelines, one of the most startling statements made regarding GM micro-organisms is the admission that they can in fact survive digestion.

Codex says,

“In some processed foods, they [GM micro-organisms] can survive processing and ingestion and can compete and, in some cases, be retained in the intestinal environment for significant periods of time.”[1]

While this statement is not revolutionary, it is quite surprising to see it uttered by Codex Alimentarius, an organization that seems to go to great lengths to approve GM products.

Nevertheless, the fact that these micro-organisms can survive digestion is extremely important to the GMO safety debate. So are the questions of rDNA retention in the intestinal tract, the potential for changing the intestinal flora of those consuming the GM product, and the subsequent effects on the immune system.

These are all concerns that Codex tacitly admits the existence of, simply by acknowledging the need to test them.[2]

 

Yet the tendency of GM micro-organisms to survive digestion and begin to change the makeup of the human intestines is mentioned later, in a footnote, where it is stated quite openly,

Permanent life-long colonization by ingested micro-organisms is rare. Some orally administered micro-organisms have been recovered in feces or in the colonic mucosa weeks after feeding ceased.

 

Whether the genetically modified micro-organism is established in the gastrointestinal tract or not, the possibility remains that it might influence the microflora or the mammalian host.[3]

It should be noted that the idea that “life-long colonization by ingested micro-organisms is rare”[4] is highly contested by many independent scientists.[5]

 

Yet, even if one were to assume the truth of Codex’s statement, the fact that it is rare means that it is still possible. More importantly, the statement admits that, even without long-term residence in the intestinal tract, there is still the distinct possibility that it will still significantly affect the intestinal flora and likewise the host itself.

Still more obviously biased concerns exist in the subsection dealing with the information that should be provided on each of the DNA modifications or micro-organisms. This information is, for the most part, very basic. It contains such data as which genes are added, the number of insertion sites, etc.

 

However, two sources of information that are required to be included cause some concern.

The first is the inclusion of the,

“identification of any open reading frames within inserted DNA or created by the modifications to contiguous DNA in the chromosome or in a plasmid, including those that could result in fusion proteins.”[6]

The second is the,

“particular reference to any sequences known to encode, or to influence the expression of, potentially harmful functions.”[7]

Yet, both of these expressions (fusion proteins and genes that express harmful functions) are considered potentially dangerous even under the weak Codex standards.

 

These expressions refer to the ability of some proteins to fuse with other proteins of the same and other species, mutating the DNA of the species, or forcing it to produce potentially adverse effects. Neither of these characteristics should be present in food, yet Codex mandates only that they be reported, not removed, as a result of the testing.

 

This appears to be a continual thread of Codex’s Guidelines.

Thus, Codex continues by saying that additional information should be provided

to demonstrate whether the arrangement of the modified genetic material has been conserved or whether significant rearrangements have occurred after the introduction to the cell and propagation of the recombinant strain to the extent needed for its use(s) in food production, including those that may occur during its storage according to current techniques;[8]

...as well as,

to demonstrate whether deliberate modifications made to the amino acid sequence of the expressed protein result in changes in its post-translational modification or affect sites critical for its structure or function;[9]

While reporting information related to the instances above might seem like a good idea (and certainly few would argue that it isn’t), simple reporting is not enough.

 

Indeed, these issues, as well as the others mentioned in this section of the Guidelines, are related directly to the question of the stability of genetically modified organisms.

 

This is mentioned briefly in this section of the Guidelines, most notably in a footnote where it says,

Microbial genes are more fluid than those of higher eukaryotes; that is, the organisms grow faster, adapt to changing environments, and are more prone to change.

 

Chromosomal rearrangements are common. The general genetic plasticity of micro-organisms may affect recombinant DNA in micro-organisms and must be considered in evaluating the stability of recombinant DNA micro-organisms.[10]

It is clear that GM organisms are often dangerously unstable.

 

Many of them carry genes that overproduce a certain characteristic, cannot be turned off, or simply begin to change even after it has been bonded to the new strain of DNA.

Yet, with all of these admissions by Codex as to the dangers that GM micro-organisms pose to those who consume them as well as the fact that GM DNA is often unpredictable, the Codex Guidelines recommendations for testing suggest that these micro-organisms should be assessed based upon tests conducted on the conventional counterpart, not the micro-organism itself.

If tests conclude that the questionable micro-organisms are removed or rendered non-toxic in their individual and natural states, then,

“viability and residence of micro-organisms in the alimentary system need no examination.”[11]

Embodying the impracticality and unscientific methodology of substantial equivalence in this context, Codex does not take into account the various potential dangers that it mentioned just a few short paragraphs previous.

Even on the question of antibiotic resistance, Codex takes the position of ignoring sound science in terms of its allowance of antibiotic resistant genes to be used as recipient organisms.

 

It says,

In general, traditional strains of micro-organisms developed for food processing uses have not been assessed for antibiotic resistance. Many micro-organisms used in food production possess intrinsic resistance to specific antibiotics.

 

Such properties need not exclude such strains from consideration as recipients in constructing recombinant-DNA micro-organisms.[12]

Although Codex does suggest that transmissible antibiotic resistant genetic strains should not be used, it clearly states that they should not be removed from consideration for use.

 

This does little to ease the concerns related to antibiotic resistance in general. This is because, as mentioned earlier, any gene that is inserted into another organism via genetic modification is inherently unstable. Not only that, but this process creates the potential to destabilize other genes as well. So the possibility still exists even when not using what is considered a “transmissible” gene.

 

Codex, of course, does not address this issue. It merely suggests that these antibiotic resistant genes not be removed from consideration as potential transfers and recipients.

The final mention of Codex’s treatment of GM micro-organisms revolves around some of the testing methods used to determine the potential of allergenicity – Sequence Homology and Pepsin Resistance testing.

 

With the exception of the specific serum tests mentioned earlier (the more reliable form of testing when adequately provided for), these are the only two methods mentioned for determining potential micro-organism allergens.

The problem with both of these methods is that they are insufficiently geared to the task.

 

By Codex’s own admission, Sequence Homology only assesses,

“the extent to which a newly expressed protein is similar in structure to a known allergen,” not whether the protein actually is an allergen.[13]

But even this limited testing ability is challenged by the fact that the test can only be conducted by using sequences of allergens that are already known and available in scientific literature and public databases.[14]

 

The document also says,

“There are also limitations in the ability of such comparisons to detect non-contiguous epitopes capable of binding themselves specifically with IgE antibodies.”[15]

Therefore, the Pepsin Resistance test is just as problematic as Sequence Homology because, as Codex admits,

“a lack of resistance to pepsin does not exclude that the newly expressed protein can be a relevant allergen.”[16]

Because several food allergens have demonstrated a resistance to pepsin digestion, it was conceived that this method of testing would be useful for determining potential food allergens.

 

However, this is obviously not the case as the correlation between pepsin resistance and allergenicity has not been fully investigated in its own right.[17]

There is also the potential for Codex to use the some to ignore the many, i.e. actually using pepsin resistance testing to claim that if a substance has no pepsin resistance, then it is not a potential allergen.

In the end, the Codex position on GM Micro-Organisms and the potential safety implications of these organisms is yet more example of Codex’s complete and intentional obfuscation of the relevant scientific data. In cases where the science supports Codex’s position, the science is touted at every available opportunity.

 

When it does not, the science is ignored.



 

 

Notes

[1] "Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P.39
[2] Ibid. p.42
[3] Ibid. p.48
[4] Ibid.
[5] Smith, Jeffrey. “Seeds Of Deception.” YES Books, 2003.
[6] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P. 44.
[7] Ibid. p.45
[8] Ibid. p.45
[9] Ibid. p.45
[10] Ibid.
[11] Ibid p.49
[12] Ibid. p.49
[13] Ibid. p.53
[14] Ibid. p.54
[15] Ibid. p.54
[16] Ibid. p.54
[17] Ibid.

 

 

 

 

 

 

 

Part 9

February 26, 2013

 

 

In my last article entitled, “Codex Alimentarius and GM Food Guidelines Pt.8”, I detailed the Codex Alimentarius position regarding Genetically Modified (GM) Micro-Organisms. Similarly, in several of the articles I have written recently, I have also discussed the Codex position on GM plants and other GM organisms.

Yet, no analysis of the Codex Alimentarius positions on GM food and/or organisms would be complete without a discussion of the Codex position on GM animals.

Indeed, the “Guideline For The Conduct of Food Safety Assessment of Foods Derived From Recombinant-DNA Animals,” a subsection of the Codex document “Foods Derived From Modern Biotechnology,” is as interesting for the concerns that it does not address as for the ones that it does.

 

Largely a copied and pasted version of the two sections before it, (“Guideline for the conduct of food safety assessment of foods derived from recombinant-dna plants” and “Guideline for the Conduct of Food safety Assessment of foods produced using recombinant-dna micro-organisms”) the GM animal Guidelines does not address some very key issues such as:

  1. Animal welfare

  2. Ethical, moral and socio-economic aspects

  3. Environmental risks related to the environmental release of recombinant-DNA animals used in food production

  4. The safety of recombinant-DNA animals used as feed, or the safety of animals fed with feed derived from recombinant-DNA animals, plants and micro-organisms.[1]

As can be easily seen, these issues are extremely important in their own right. Just the moral issues, in addition to the hazards of the potential of GM animals being released into the environment, are enough to fill volumes. However, Codex chooses not to deal with these issues in its Guidelines.

 

With that being said, because Codex treats GM animals essentially the same as GM plants, there is very little difference in the guidelines. This shows a lack of scientific zeal as animals are fundamentally different than plants.

Yet one area where Codex does address a different aspect of the GM safety question is related to veterinary drug residues. It says,

Some recombinant-DNA animals may exhibit traits that may result in the potential for altered accumulation or distribution of xenobiotics (e.g. veterinary drug residues, metals), which may affect food safety.

 

Similarly, the potential for altered colonization by and shedding of human pathogens or new symbiosis with toxin-producing organisms in the recombinant-DNA animal could have an effect on food safety.[2]

With its implicit admission of the instability of modified genes, Codex now also admits that these genes, when changed in animals, could affect the distribution and retention of veterinary drugs and other substances which would necessarily change the content of the food product derived from that animal.

 

As Codex states, this same situation could also apply to human pathogens as well as veterinary drugs.

As a side note, it appears that 2007-2008 was a very beneficial year for GMO food producers. Not only were the pro-GM testing Guidelines approved by Codex, but many countries, such as the European Union who had been opposed to the introduction of GM food up to this point, began changing their position to one that was slightly more open to GMO.

For instance, in 2008, Codex Alimentarius approved Guidelines that would allow low levels of GM products that have not been approved by the countries’ regulatory agencies inside products that are imported into the country.

 

This would include products like grain, corn, and oats. Codex claims that this set of standards merely recognizes the fact that GM products will inadvertently mix with non-GM products during processing and transportation and that it means to provide guidance in this unavoidable situation.[3]

However, this presupposes that GM contamination of food shipments is unavoidable when in fact just the opposite is the case. If GM products were not used to begin with, the entire issue would not need to be addressed.

Also, if countries that did not approve of GM products would simply refuse to import them if they were contaminated with one single GM organism, then the fact that the majority of people do not want GM food would be driven home.

 

This would be a great move for both the exporting and importing countries in that GM would be made economically unfeasible as well as forcing the importing country to produce their own food.

 

It may come as a surprise to many that these Guidelines were approved with the consent of the European Union, the very state that has voiced much dissent to GM products in the past. This is a clear signal that the European Union, now that is has become even more integrated than it was when the GM debate first appeared, is preparing to accept GM food on the level of the United States in the future.

While these Guidelines only apply to GM contamination of imported food, the European Union’s own guidelines have become much more relaxed in relation to GM food production within its borders. It is here that the various European countries are experiencing the tyranny of being a member of a European super-state that undermines their national sovereignty.

In March 2010, against the objections of countries such as Italy and Austria, the European Union’s European Commission approved an antibiotic resistant genetically modified potato.[4]

These countries who, before joining the EU, would have had complete authority to block the importation and production of GM material now must defer to the EU court and commission system that are clearly undemocratic and unconcerned with the safety of the European people.

This is the same situation that occurred in 1998 when the European Union approved the MON810 strain of GM maize developed by Monsanto against the protest of several EU states.

Subsequently, several member nations banned the cultivation of the maize which now pits them against the European Commission in an ongoing battle for national sovereignty.[5]

However, sovereignty is not likely to win out.

In 2007, the European Court of Justice overturned Austria’s ban on cultivation of GMO’s even though Austria has the broad support of its people and other nations.

The court also ruled that individual countries had no right to deny farmers the ability to grow GM crops that the EU had previously approved. This ruling has effectively removed Austria’s total cultivation ban. While many other Austrian regulations are in place that will make it a little more difficult for GMO production than in other countries, the European Commission and Courts will likely continue to chip away at them little by little.[6]

India has also relaxed its opposition to GM foods as evidenced, also in 2007, by the fact that the Indian Ministry of Environment and Forests announced that organisms that are not living (living being defined as an organism capable of replication) will now be exempt from the existing approval processes. This effectively allowed all “non-living organisms” into India without any testing at all.

 

This applied to a wide range of products such as those containing GM corn or soy.[7]

It should also be mentioned that as of January 2009, the FDA has announced that labeling of GM food animals is not required at the consumer level.

While GM animals are required to be labeled while alive, when the animals reach the food stage, the labeling requirements disappear. GM animals are only required to be labeled at the food stage when there appears to be a substantial difference in the food product.[8]

However, it should be remembered that, because the FDA works on an even more relaxed version of substantial equivalence than Codex, it is already assumed that these foods will not be significantly different from a conventional counterpart.

Thus, we have unfettered access of GM animal food products to the food supply with no way for the consumer to determine whether or not the product he/she is eating has been genetically modified - a step which the FDA and Codex Alimentarius have both worked so hard to reach in the past.

 


 


Notes

[1] “Foods Derived From Modern Biotechnology,” 2nd edition. Codex Alimentarius. P. 57.
[2] Ibid. p.71
[3] “Codex Alimentarius Commission: New Standards, old concerns,” July 14, 2008.
[4] Hickman, Martin; Roberts, Genevieve. “Fury as EU approves GM potato.” The Independent. March 4, 2010.
[5] “EU food authorities say genetically modified maize is safe.” AFP. June 30, 2009. Accessed May 24, 2010.
[6] “Further ‘Rubberstamp’ GMO Approvals In The Pipeline In Europe.” Bridges Trade BioRes October 5, 2007. Vol. 7 No. 17.  Accessed May 24, 2010.
[7] “India Fast-Tracks Imports Of Non-Living GM Material.” Bridges Trade BioRes October 5, 2007. Vol. 7 No. 17.  Accessed May 24, 2010.
[8] Reinberg, Steven. “FDA Issues Final Regulations for Geneticially Engineered Animals.” US News And World Report. January 15, 2009.  Accessed May 24, 2010.