This is a report to colleagues about recent developments in the Codex Alimentarius regarding regulation of genetically engineered foods. It will cover two arenas of Codex-related activities: the third meeting of the Ad hoc Task Force on Biofoods (TFB) (Yokohama, March 2002); and a briefing held by the US Codex Office on March 26th (which I participated in by speaker telephone) in preparation for the forthcoming meeting of the Committee on General Principles (CCGP) in Paris, April 15-19, 2002.

The substantive topics to be addressed are Coverage (of different documents/legal regimes), Risk Analysis, and Traceability. I also want to mention NGO participation.

Coverage of Legal Instruments

Whereas the Cartagena Biosafety Protocol covers “Living Modified Organisms used as Foods” (and not the “products thereof”—a battle we lost), the TFB covers all foods “derived from biotechnology” (with “biotechnology” defined as in the Protocol)—i.e., a much larger category. The CCGP deliberations cover all foods however derived, a larger category still.

Yokohama Task Force Meeting

Much to the surprise of most, if not all, participants this meeting actually completed and adopted 2 documents (advancing them to the Commission, which meets in Rome in July of 2003): “General Principles for the Risk Analysis of Foods Derived from Modern Biotechnology” and “Guidelines for the Conduct of Safety Assessment of Foods Derived from Recombinant-DNA Plants” (the Guideline is one of what will be a set of documents under the Principles). These have been quickly and specially posted on the Codex website <http://www.codexalimentarius.net/biotech> “due to public interest.” According to the Codex press release

The Principles will provide a framework for evaluating the safety and nutritional aspects of Genetically Modified (GM) foods. They define the need for a pre-market safety assessment of all such foods on a case-by-case basis. According to the UN agencies, the assessment should look into both intended and unintended effects, identifying new or altered hazards and identifying changes, relevant to human health, especially in regard to key nutrients and potential allergenic components.
The Principles would require authorities to consider the uncertainties identified in the safety assessment and implement appropriate measures to manage these uncertainties. One management option described in the Principles is post-market monitoring. The Principles also provide guidance related to analytical methods and other tools to be used in risk management. In this area, the two agencies say that the Task Force "reached a very important new agreement concerning the tracing of GM products for the purpose of facilitating withdrawal from the market when a risk to human health has been identified."

The task force also adopted detailed requirements for assessing the safety of GM plants including tests for allergenicity . . .

Given the hard difference of positions between some governments on some issues, it is not clear what is the significance of this TFB consensus action; indeed, subsequent news reports and comments (and there have been many) are not in accord in describing what is going on:

• The Canadian Globe and Mail (March 26th) said there was “a truce of a sort” in hammering out a “global accord,” while quoting widely disparate views of what the texts meant. (see http://www.theglobeandmail.com);
  
• A Codex official called it “a very important new agreement concerning the tracing of GM products for the purpose of facilitating withdrawal from the market when a risk to human health has been identified.” (Reuters, see <http://abcnews.go.com/wire/Living/reuters20020308_480.html>)
  
• "The agreement could also mark a breakthrough in international negotiations concerning the use of tracing systems in relation to food in international trade," the FAO and WHO said in a statement quoted in the UN Wire, an electronic publication of the National Journal Group.
• Reports were also carried in CropChoice News and the BRIDGES Trade Digest
  

The US delegation (almost 9% of the total delegates at the meeting) appeared very satisfied with the results (as were their comrades in the Canadian, Australian, Brazilian, Philippines, and other delegations), while congratulating us green NGOs for our hard fighting. However, one green NGO participant has concluded:

We got one little victory: the ban on Antibiotic resistant marker genes for widely disseminated food we won last year, was further strengthened in deleting the terms «widely disseminated». So ABR genes that encode resistance to clinically used antibiotics should not be present in any foods according to the new guideline.


GE industry is anyway phasing out the use of ABR marker genes for commercialized GM products, so this step seems to me more a desperate attempt of GE industry to win back consumers confidence rather than a real progress in direction of consumers protection.

And besides this the wording of the Codex guidelines was further weakened with terms as «where appropriate, if applicable, could, may» etc.

More and more it becomes clear that the global Codex Standards for GM food will finally be very low. The burden of proof for any health risk will be on the consumers side and no precautionary principle will be established asking a proof for harmlessness before putting GM foods on the market.

Because the Codex standards are WTO standards, governments, establishing stronger levels for protection against possible harmful impacts by GMO’s, risk a WTO complaint for illegal hindering of free trade.

Jean Halloran, of Consumers International, sent a report with a different viewpoint to many US activists, as follows:

Last week I attended a meeting of the Codex Ad Hoc Task Force on Foods
Derived from Biotechnology in Yokohama, Japan, representing Consumers
International. (Phil Bereano was also there representing the 49th Parallel
Consortium). Somewhat surprisingly, the meeting reached consensus on two
documents, both basically dealing with safety assessment of genetically
engineered food. In my view, both these documents, to which the US
delegation, headed by Bob Lake and James Maryanski of FDA, agreed, can be
helpful to us here in the US. The full text should be available soon on the
Codex web site.

The first document describes overall principles for risk assessment.
Included in it is a clause on "product tracing" which states "Specific tools
may be needed to facilitate the implementation and enforcement of risk
management measures. These may include appropriate analytical methods;
reference materials; and, the tracing of products for the purpose of
facilitating withdrawal from the market when a risk to human health has been
identified or to support post-market monitoring..." There is a footnote to
this clause which reads "It is recognized that there are other applications
of product tracing. These applications should be consistent with the
provisions of the SPS and the TBrt agreements. The application of product
tracing to the areas covered by both agreements is under consideration in
Codex on the basis of CCEXC decisions at its 49th session." Although it is
given a slightly different name, this was the resolution of the discussion
on traceability. Given that previously the US has been unwilling to use the
T word in any form whatsoever, this is a big step forward.

This document is referenced to Codex Committee on General Principles
discussions in regard to precautionary principle and use of "other
legitimate factors." In terms of "substantial equivalence," this document
describes it as a starting point, rather than an ending point of risk
assessment, which is a very good thing.

In the second document, the end point of risk assessment is described as a
judgment about whether a genetically engineered food is "as safe as" its
conventional counterpart. Although there was a huge effort by the US to
define conventional counterparts as including GMOs, this rather amazing
notion was beaten back to the point where a footnote states that
conventional counterparts will not include GMOs "for the forseeable future."

The second document describes how to assess a GMO for potential toxicity,
allergenicity, and nutritional changes, and unintended effects, all in some
detail. Although it isn't perfect--one of the worst problems is that in a
number of places assessment can be done on a similar or closely related
substance--nevertheless this it actually fairly useful as a safety
assessment protocol. Two specifics are particularly noteworthy. It states
that transfer of genes from commonly allergenic foods should be avoided
unless it is documented that the transferred gene does not code for an
allergen. (FDA's current official policy is that any such problem can be
solved through labeling.) Codex also says that "antibiotic resistance genes
used in food production that encode resistance to clinically used
antibiotics should not be present in foods."

All in all, these documents firmly establish that genetically engineered
foods should be assessed for certain potential risks to human health, before
they go to market, and their safety assured. This is a higher standard
than what we currently have at FDA in the US, which only has voluntary
consultations, the content of which is unknown.

A Japanese delegate from a green NGO expressed to me that she was “not fully happy with the outcome. . . . I could not understand why the US agreed and even was so happy with the 2 final documents. . . maybe they have some conspiracy (going on) that would astonish us years later.”

I conclude from my experiences in Yokohama, and respecting the judgments of my colleagues, that the import of these documents is ambiguous, and their true meaning will evolve in the future, depending in large part on the vigilance and participation of environmental and consumer NGOs in the Codex processes that these documents establish and also in our continued pressure/lobbying of our own governments.

The main obstacle to agreement was, clearly, the desire of France and other EU delegations to provide for “traceability” of GE foods, as a way to track, in the face of considerable uncertainty about the safety of GE foods, whether any health problems develop. This traceability idea is clearly related to a precautionary approach. The US and its allies adamantly opposed this, and suggested last year that “traceback’ was sufficient. (Traceback is when a hazard has already been established—such as the risk of botulism in canned foods—a tracing system is established so that if incidents of disease occur, the offending processor/factory can be identified, both for correcting the manufacturing process as well as establishing legal liability.) I have previously circulated materials put out by 49P analyzing the positions of these two governments. The US makes frequent reference to the good work on this issue being done at the Committee on Food Import and Export Inspection and Certification Systems (CCFICS) which, being chaired by Australia, presumably involves a weaker formulation of the matter; the activities there need to be better monitored by NGOs. The TFB compromise wording satisfies both sides--each can pretend that they got their way--but actually just avoids the real controversy. No “truce” here. As Bruno Heinzer of Greenpeace has expressed it:

Some compromises on the most disputed points could have been found, generally in replacing the draft wording by further vague, non-defined terms.

Most outstanding example was the «solution» for the year-long fight on the issue of traceability:
After a long but fruitless discussion, to general surprise, an «Informal proposal» elaborated by Canada, EC, UK, Thailand during an Ad Hoc Lunch time meeting was presented to the Task Force, replacing «Traceability» by the term «TRACING».

The complete agreed wording of the concerned paragraph 21 of the general principles document is now:

«21. Specific tools may be needed to facilitate the implementation and enforcement of risk management measures. These may include appropriate analytical methods; reference materials; and, the tracing of products (footnote 9) for the purpose of facilitating withdraw from the market when a risk to human health has been identified or to support post-market monitoring.

9) It is recognized that there are other applications of product tracing. These applications should be consistent with the provisions of the SPS and TBT agreements.»

The vague and non defined term «Tracing» opens wide room for interpretation: The US/GE industry will interpret it as traceback (just to minimise hazards after a concrete accident), while the EU countries and others will interpret it as traceability as defined in the French position paper, that means as a concrete application of the precautionary principle operating in both directions back to the source and forward to any potential harmful effect.

[The French delegate, when asked at the final session how she understood the English word “tracing” replied, to much laughter, “tracebilité.”]

Other major points to be aware of:

• The documents still do refer to “substantial equivalence” but this is clearly interpreted, using FAO/WHO Expert Consultation language, as not being the “endpoint” of a safety assessment (as it is in the USA under the 1992 FDA rules) but merely the beginning. IE, one can use analogy in scientific reasoning (nothing new here). However, a new concept, called the “conventional counterpart,” has been introduced for making the comparison—this could turn out to be “substantial equivalence” all over again, the proverbial wolf in sheep’s clothing.
  
  
• Risk analysis is discussed in terms of 3 components –risk assessment, risk management, and risk communication—despite the objections of several of us that the process is much more iterative and interactive than such segmentation implies. True, there is language recognizing that these are not wholly separate activities, and even language recognizing that “scientific” and “objective” risk assessment has some subjective and hard-to-quantify elements.
  
  
• “Risk assessment includes a safety assessment, which is designed to identify whether a hazard. . . is present, and if present, to gather information on its nature and severity.” Try as I may, after 3 years of these meetings and 20 years of teaching about this topic, I don’t understand what is going on here. “Safety” is defined in the literature as what comes at the end –ie, the acceptability or not of the level of risk that has been uncovered. Aside from this use of a confusing label, the documents’ discussions of “safety assessment” seems to fully encompass their concept of “risk assessment”. So it appears to me that there are 2 names for the same process. This risk document is, in my opinion, much more technocratic and confusing than the corresponding document the CCGP is discussing, but the CCGP document is many years away from adoption. Unfortunately, I suspect the US and its allies may try to press for using the TFB approach as a model for the CCGP guideline.
  
  
• The closest language to any notion of precaution is in paragraph 18 of the Risk Analysis document: “Risk managers should take into account the uncertainties identified in the risk assessment and implement appropriate measures to manage these uncertainties.” Not very strong.
  

Protecting the Protocol

Many NGOs believe that the Cartagena Protocol, even with the weaknesses we know are in its text, still represents an important beachhead our movement has helped to establish against the untrammeled actions of the biotech industry. And we are aware of how Codex ignored the Protocol in the early meeting of the TFB. So we have authored and circulated a letter that was presented to the Task Force (and -–with many more signatures—will be presented to the CCGP) insisting that the delegates take into account the relevant Protocol provisions as they deliberate, particularly Article 18 (on transport, handling, and identification, which envisions a system of traceability coming into effect within 2 years of ratification) and the Precautionary Principle which, by explicit terms of the Protocol’s Preamble, is not subservient to the WTO.

This letter was made an official Conference Room Document (CRD 15). A lengthy discussion occurred on the last day of the Task Force in regard to this matter, in the review of the draft of the report of our sessions. Under the “traceability” section it is noted that “One NGO referred to the identification requirements of Article 18 of the Cartagena Protocol as having relevance to the use of traceability “ (Para 26). The US delegation spent some 20 minutes trying to remove the following sentence from the next paragraph (27) “The representative of 49th Parallel noted that such applications on product tracing would also need to be consistent with the provisions of the Cartagena Protocol after its entry into force.” One can surmise that the US is loath to accord any legitimacy to the Protocol’s approach, especially to this provision which (as most of you know) was the last item to finally be decided in Montreal. The EC, France, and Belgium, were our clear supporters in this debate, with the Secretariat making the not-quite-relevant observation that Article 18 does not contain the word “tracing.” (Well, it doesn’t contain the word “labeling” either, but the EU Environmental Ministers in Montreal seemed very clear that the provision would help give them support for such a requirement.)

US Codex Briefing, March 26th

The major issues to be addressed by the upcoming CCGP meeting are risk analysis (by Codex itself; risk analysis guidelines for member governments will be worked on later); traceability; a “Code of Ethics for International Trade in Foods;” co-operating with international intergovernmental organizations (apparently mainly industry associations); and Codex membership by “regional economic integration organizations” (ie, the EU).

As an overview, it appeared to me that the US was eager to consolidate what it sees as its “successes” and to push its views even more vigorously in future venues. Ed Scarborough, the head of the US Office, called traceability the “most significant issue.” It is clear that they believe the TFB’s use of “tracing” does not mean traceability. Traceability will come up 3 places in the CCGP agenda—in the “Matters Referred” by other Codex bodies (the above-noted paragraph 27 from Yokohama is prominently noted in this agenda item), the discussion of risk analysis for Codex, and an anticipated paper by France on the use of traceability by governments (regarding the future Committee work). The US preferences, regarding Codex risk assessment, in descending order are:

* have no provision on traceability (leave it to the governments);
* if it is included, tie it tightly and solely to safety considerations;
* emphasize that the Codex Executive committee gave CCGP a narrow
charge—to develop just a “principle,” not an operative “guideline;”
* the Yokohama wording (“tracing”)
* oppose any Working Group on Traceability as unneeded.

The CCGP risk document has material on precaution in 2 sections, and the US will vigorously oppose these. Traditional issues—such as the level of confidentiality to be accorded information supplied by industry—will surface. This document also has a lot of potentially good material (from our point of view) about “risk communication” emphasizing transparency, two-way exchanges of information (eg, the lay public as a repository of relevant information and expertise, etc.). Much of this was developed at a workshop in December and the US is prepared to argue that it needs to be considered more carefully, is illogically worded, could readily be misunderstood, etc.

In regard to risk analysis by countries, a discussion paper by India was discussed at the briefing in patronizing terms (eg, developing countries have to accept that certain rules have already been determined and there can’t be a second discussion attempting to change them).

But it was anti-European feelings that were most-widely in evidence. (Those of you outside the US may not be aware of how this attitude is being fanned in US government /media/and academic circles—not just because of GMO issues, but also in regard to trade concerns such as steel, different sensibilities on questions of Iraq and Palestine, US hegemony generally but especially re: the “war” on terrorism, etc.). And the discussion about EU membership in Codex (which is assured since one of the parent organizations—FAO—has already given its approval) verged on the paranoic. (The EU’s actual proposal didn’t help, however, allowing, for example, different voting configurations—15 votes as a bloc or 15 individual free votes-- for different issues, which sounded to some US officials as a bid to “manipulate voting power.”)

Conclusion

The title of this report is a play on words in English (for those of you with a different family tongue) designed to suggest that it covers Codex “topics” but also that these topics are, in my judgment, “important”.

Given the discussion above, I’m sure you can see that Codex is a venue where issues relevant to all of our organizations are being discussed and decisions are being taken which will impact our constituencies and affect the values and concerns that we hold so deeply. Thus, I want to renew my plea that more NGOs become approved as “Observers” (which is what Codex calls civil society participants, in its partially-transparent procedures.) We need more folks to strategize with, to show the depth of our concern, and finally to “give ‘em hell.” It would be great to have more greens in Yokohama next year, Paris next year, Halifax next year for labeling, Brisbane next year, etc. I’m happy to help folks with the application process, which is not onerous. But you must, yourself, be a group in more than one country; if not you can do what we did, pair up with neighboring NGOs and create an instant Codex-ready NGO.

My best in the struggle,

Phil
April 4, 2002