Tuesday, November 13, 2007

Notes Skyped from Codex by Dr. Laibow

The Codex Committee on Nutritional Foods, etc. is meeting in Germany. Dr. Rima Laibow and Gen. Stubblebine are attending on behalf of Natural Solutions Foundation. While she was "in the balcony" (see my blog entry of 11/11/07: "Codex: Empty room, empty minds..."] we were chatting on Skype. Here is the flavor of being at a Codex meeting... my comments in brackets.

IADSA [International Alliance of Dietary/Food Supplement Associations - http://www.iadsa.org/ ] is speaking about the Health Claims provision in the CCNFSDU [a Codex committee]. They want human study requirements to be removed. They want to give more weight to epidemiological studies and the substantiation of health claims should be carried out on a case by case basis with equal weight for all types of evidence. They do not think that human studies should have more weight than observational studies or than epidemiological studies.

There is a coffee break now: Dr. Grossklaus [committee chair] is saying that there is a hierarchy of evidence: the most valid scientific data, considering the totality of evidence, but essential factors are not just the quality of the animals or in vitro test but you cannot weaken the hierarchy and say that human tests are not the most important. "That is something that we cannot say!"

Dr. Rima comments: This position violates basic principles of the Declaration of Helsinki on human experimentation. At the same time, the Codex process is trying to turn nutrients into drugs by using the same sort of "Risk Analysis" pseudo science for health claims even though drugs are not part of the human experience since the beginning of evolution and foods and food components are. They want to apply drug system tests to foods but allow "novel nutrients" produced by [genetically modified] GM plants into the food supply and only do assessments of their safety (i.e., dangers) "WHEN APPROPRIATE!" [NSF believes is is always "appropriate" - necessary - to substantiate the safety of new chemical species when offered for sale to the public.]

Here is the introduction Australia just gave to the Proposed Draft Establishment and Application of Risk Analysis [RA] to nutrients:

AUSTRALIA: We have been involved in a series of papers as early as 1998 and it is with much pleasure that we have been able to bring the procedures to this point where we are starting the next step procedure. We note that the working principle for RA to be conducted in Codex was adopted in 2003 and is part of the working manual. In 2006 WHO consultation for developing upper levels of intake was a critical piece of information. We have been able to develop a series of RA principles that draw on those documents. We note that Codex itself has specifically mentioned RA in the 2008-2013 strategic plan so the time is right.

The principles will be considered at step 3 this year, step 5 next year and finalized at step 8 in 2009. This is a document for Codex, not governments*. It will eventually be published in the procedural manual. The document does follow the working principles but also sets out that it is dealing with nutritional risk analysis and it differentiates that from traditional food safety RA, introduces the term "and related substances." [Euphomism for "genetically modified?] We note that there are strong links with the biotech document and the principles that we are developing, its reliance on the principles of bio-availability and its strong use of “nutritional benefits” [this means GM prodcts can make health claims... but natural nutrients... NOT! See: Dr. Laibow's blog on this subject, http://www.healthfreedomusa.org/index.php?p=443 ].

We are looking at nutrients as substances of primary interest. We have picked up the idea of RA being either qualitative or quantitative. Opportunities to apply a fully quantitative systm of RA are fairly rare and perhaps the opportunity here is to use more qualiftative RA approach. We have introduced the term risk/risk analysis (ex, Hg and fish where there are risks in both options).

Definitions have been adapted from those published in the Codex procedural manual and additional definitions have been inserted from WHO and FAO documents or expert consultations. The principles of RA have risk assessment, risk management and risk communication systems. There has been additional attention given to risk management and risk communication. We have developed principles for nutritional risk assessment, hazard identification.

There was an attempt to look at processes that are in process in other places to see if we could proceed to risk characterization at the international level.

There is a special session re: risk assessor because our committee is not in the position of other committees with long standing sources of advice. WHO and FAO are the primary sources of information but other sources can also play that role. The principles, having been developed ahead of any experience, should be reviewed at suitable internals taking into account other experiences in the Codex context.

[So there we have it, Risk Analysis, which puts all nutrients at risk, thereby greatly impacting Health Freedom, is based on principles "developed ahead of any experience..." Right, and that's what they call "scientific!" So it goes... If you want to stay completely up to date with Codex and the like, please go to http://www.globalhealthfreedom.org and sign up for the eAlert list!]

Ralph Fucetola JD

Note: * - this admission, that Codex standards bind Codex, not governments, is tactic admission that our NSF Codex 2 Two legal approach to protecting countries from Codex restrictions is valid. See: http://www.youtube.com/watch?v=6QNg3MD6BxM

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