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THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

30 June 2003

Dear Friends and colleagues,

RE: DEFICIENCIES IN CODEX'S DRAFT GUIDELINES

The Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology has advanced the following documents, among others, to the 26th session of the Codex Alimentarius Commission, beginning 30 June, for adoption:

1. Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (ALINORM 03/34; Appendix III)

2. Draft Guideline for the Conduct of Food Safety Assessment on Foods Produced Using Recombinant-DNA Microorganisms (ALINORM 03/34A; Appendix II)

 While both Draft Guidelines are comprehensive and a step forward, there are still, however, deficiencies remaining. Among these, as the TWN Briefing highlights, is the lack of explicit requirement for animal testing and continued reliance on 'substantial equivalence'. Furthermore, they lack mandatory requirements for the phase out of antibiotic resistance marker genes, for labelling and traceability and for adoption of the Precautionary Principle.

The Draft Guideline related to foods derived from r-DNA plants is narrow in scope, excluding animal feed and animals fed on such feed, as well as environmental impacts. Additionally, it fails to explicitly require event-specific characterisation of the transgenic line or documentation of genetic stability with molecular data.

Because of the lack of knowledge on endogenous microoragnisms in the human gut, there are many uncertainties associated with foods produced using recombinant-DNA microorganisms. The concerns raised include that of horizontal gene transfer between r-DNA microbes (even if dead) and microbes in the human gut, as well as interaction with resident microbes and the human immune system.

The Draft Guidelines and information on the 26th Session of the Codex Alimentarius Commission can be found at: http://www.codexalimentarius.net/codex/codex-e.htm

With best wishes,

Lim Li Ching and Chee Yoke Heong

Third World Network

121-S Jalan Utama

10450 Penang

Malaysia

Email: twnet@po.jaring.my

Website: www.twnside.org.sg

 

REF: Doc.TWN/Biosafety/2003/C

Third World Network1 Briefing for Codex Alimentarius Commission (26th Session, 30 June-7 July 2003, Rome)2

The Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology has advanced the following documents, among others, to the 26th session of the Codex Alimentarius Commission for adoption:

1. Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (ALINORM 03/34; Appendix III, para(s) 61)

2. Draft Guideline for the Conduct of Food Safety Assessment on Foods Produced Using Recombinant-DNA Microorganisms (ALINORM 03/34A; Appendix II)

While both Draft Guidelines are comprehensive, they however remain deficient, in that:

1. No animal testing is explicitly recommended or required, and no clinical tests either, because food is said to be too complex. This reasoning is fallacious. Animal testing has been, and should be, part of a science-based protocol that assesses the safety or otherwise of foods derived from modern biotechnology.

2. The highly questionable principle of 'substantial equivalence' is still used to justify reductionist risk assessment, i.e., to focus on perceived differences only, thereby potentially ignoring unintended, unpredictable, systemic effects.

3. There is no mandatory requirement to phase out antibiotic resistance marker genes.

4. There are no mandatory requirements for labelling and traceability.

5. There is no requirement to adopt the Precautionary Principle.

Specifically, the Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants is still lacking, in that:

1. Its narrow scope does not include animal feed and animals fed on such feed, or environmental impacts. The possibility cannot be excluded that feeding recombinant-DNA plants or plant products to animals also carries risks, not just for the animals but also for human beings consuming the animal products.

2. No event-specific characterisation of the transgenic line or documentation of genetic stability with molecular data is explicitly required.

The Draft Guideline for the Conduct of Food Safety Assessment on Foods Produced Using Recombinant-DNA Microorganisms remains inadequate, in that:

1. It is premature, particularly if viable or even non-viable recombinant-DNA microorganisms are contained in the food, because of the ease with which such microorganisms can exchange genes horizontally with microbes in the human gut and interact with the resident microbes and with the human immune system. There is a large area of ignorance concerning endogenous microbes, most of which cannot be isolated.

2. There is no requirement to characterise foods produced using recombinant-DNA microorganisms for transgenic DNA, when even dead recombinant-DNA microorganisms contain transgenic DNA that can be transferred horizontally to microorganisms inhabiting the gut of human beings.

More details on the hazards of genetic engineering and recombinant-DNA plants can be found in the recently released Independent Science Panel Report, The Case for a GM-Free Sustainable World www.indsp.org

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1 Third World Network, www.twnside.org.sg

2 Written by Dr Mae-Wan Ho, Director, Institute of Science in Society, www.i-sis.org.uk

 


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