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[SANET-MG] dithering with codex



The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme . Codex may be very influential, it tends to be dominated by corporate interests and there is a good deal of pressure to make Codex and its standards the world's standards for exports and imports. The codex group on genetically modified foods has been meeting for several years and as yet has not produced anything meaningful

Codex has mistakenly named Canada to collate information on the safety evaluation of GM foods apparently unaware that official Canadian government views on that subject are very loony. The letter below was circulated to collect information on gm foods.I have enclosed the cover letter and questions but did not enclose the annex paragraphs which can be obtained at the address of the Canadian codex group mentioned in the letter. Otherwise I can forward a pdf copy of the entire document to anyone interested in replying to the questions.

The 5th Session of the Codex Ad Hoc Intergovernmental Task Force on Foods
Derived from Biotechnology agreed to initiate new work in the form of an
annex to the Guideline for the Conduct of Food Safety Assessment of Foods
Derived from Recombinant-DNA Plants (CAC/GL 45-2003) and proceed with
further scoping of the work on the basis of the project document prepared
by Canada. To advance this work, the Task Force agreed to establish an
electronic working group led by Canada.  Please refer to paragraphs 28-38
and Appendix III project document of ALINORM 06/29/34 for further
information.

In accordance with the decision of the Task Force, Circular Letter
2005/46-FBT was distributed earlier in October to solicit comments on this
work.

In order to assist in the elaboration of this work, your response to the
attached Questionnaire (Annex 1) is requested to be submitted by November
28, 2005.

Your reply should be forwarded to Mr. Ron Burke, Codex Contact Point for
Canada (codex_canada@hc-sc.gc.ca).

Best regards,


Santina Scalzo
Manager, Codex Program Services
Office of the Codex Contact Point for Canada

Annex  1 - Questionnaire

The purpose of this questionnaire is to gather information in order to assist the electronic working group, led by Canada, with the drafting of a proposed draft annex (scoping document) regarding the food safety assessment of foods derived from recombinant-DNA plants modified for nutritional or health benefits.

In completing this questionnaire, delegations and non-governmental organizations are encouraged to take note of the project document provided in Appendix III of ALINORM 06/29/34 and the existing guidance contained in the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003), particularly paragraphs 44-53 which deal with such aspects as compositional analysis and nutritional modification.

The comments received will be compiled and distributed to the members of the electronic working group to assist with the elaboration of the scoping document.


Question #1: In your view, what would be important factors in determining if a recombinant-DNA plant is to be considered a ARecombinant-DNA Plant Modified for Nutritional or Health Benefit@, and as such within the scope of the proposed annex?

In your response, please elaborate on the importance of such elements as the nature of the trait introduced, the crop species, the level and site of expression, relevance to nutritional quality and/or functionality, and other elements as appropriate.


Question #2:

In order to assist with the identification of additional safety and nutritional considerations that the assessment of recombinant-DNA plants modified for nutritional or health benefit may warrant, please consider the elements listed below and for each of them provide comments on the need, added value and relevance of addressing such items given the intent of the modification introduced in such recombinant-DNA plants.

Please also consider any particularities related to staple crops of interest to populations in developing countries.


a) Estimation of potential exposure distribution patterns - how to go about determining potential exposure distribution patterns in both target and non-target populations of a country and evaluate the safety of such exposure in vulnerable groups. Techniques are available using population dietary intake data that permit modelling of usual intakes through simulated inclusion of the modified food in exchange for foods reported to be used the dietary survey. In this regard, lessons can be learned from modelling of potential intakes resulting from vitamin and mineral addition to foods;

b) Bioavailability - when bioavailability testing would be advisable and some considerations of the techniques available for determining bioavailability of various types of substances;

c) Upper limits of safe intake - the need to determine upper limits of safe intake for the nutrient or bioactive substance, if they are not already defined, and how to assess the level of exposure according to population sub-group of the substance or substances in question against those upper limits;

d) Stability - what is involved in stability testing, and why that is a component of risk assessment;

d) Risk/benefit consideration - what consideration should be given to the benefit intended to be provided by the modified food in drawing conclusions from the risk assessment. Benefits may accrue to certain target groups while at the same time, health risks may be a concern for others, but also there may be benefits at lower intakes and adverse effects at higher intakes. Additionally, how strong the evidence is for the benefits compared to potential adverse effects may need to be assessed in these circumstances;

e) Animal feeding studies - when should animal feeding studies be considered and what types of studies might be useful depending on the question;

f) Study Design - the design and conduct of studies to obtain reliable, repeatable data on composition of the modified food with respect to the intended and potential unintended changes, at the appropriate stages of crop and food production. In particular, whereas in evaluating unintended effects comparative data in the raw product is usually quite acceptable, where an intended change has been introduced, there will need to be data on the variation in tissue concentration relevant to the parts of the plant that will be used for food production and data to show that the content of the substance remains stable with time, processing and storage. The impact of factors known to affect crop composition from year to year and by geographical location, soil type and fertility, etc. may need special attention in the case of intended changes.

g) Any other considerations? Please specify.

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