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:
-
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.
-
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.
-
If a bioengineered food has a
significantly different nutritional property, its label must
reflect the difference.
-
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,
...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:
-
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.
-
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.
-
Modern Biotechnology - the
application of:
-
In vitro nucleic acid
techniques, including recombinant deoxyribonucleic acid
(DNA) and the direct injection of nucleic acid into
cells or organelles
-
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.
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.
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:
-
Animal welfare
-
Ethical, moral and
socio-economic aspects
-
Environmental risks related
to the environmental release of recombinant-DNA animals
used in food production
-
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.
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