Re: Codex proposes guidelines for non-approved GMOs
(1) Codex is a joint UN agency between FAO and WHO with about 170 member countries. It develops principles and guidelines on food issues - some highly technical, and some a mix of technical and policy elements. **No country is under any obligation whatsoever to adopt any Codex document - they are all voluntary. In addition, countries are free to adopt regulations at variance with Codex positions.**
(2) Why does it matter, then? **Under WTO rules, Codex principles are the international standards to be followed by the WTO Dispute Resolution Body.** Thus, countries have an incentive to follow Codex (so as to avoid complaints of trade restrictions); also developing countries without significant technical and administrative infrastructure, often rely on Codex as a 'ready-made' regulatory system. (This is where the EC screwed up in the GMO case brought by the US/Canada/Argentina-it didn't use the Codex defense and instead tried to use the Protocol, a much weaker theory which failed it.)
(3) The essence of State sovereignty is the ability to makes internal rules and to control what comes in across the borders. The basic notion behind WTO is that countries mutually give up some of this sovereignty in order to stimulate trade and economic development.
(4) The Annex is just that-an Annex to the GMO Plant Guidelines, which themselves are dependent upon the general Codex Principles for Pre-Market Assessments of GMO Foods. These two documents were produced by the Task Force in earlier sessions, and were the subject of several communications from me (and Michael, and Bruno Heinzer of GP, when GP was still doing Codex work). They call for **pre-market safety assessments of GE foods before they are placed on the market** and are fairly elaborate and exacting; thus, the US process clearly does not satisfy these documents.
(5) The US and industry wanted to sneak contaminated products into unsuspecting countries **that had not assessed the GMO causing the contamination.** Two years ago they proposed a draft that would have allowed a minimal assessment of the contamination if the GMO had been approved anywhere under any system, the language implying that the GMO would eventually be approved everywhere (eg, 'countries have asynchronous approvals' - can you believe the bull____ we have to deal with?!). The EU and other Members (with our assistance) shot that down.
Last year they came back with a much reduced proposal but the EU (based on its experience of receiving contaminated shipments without any knowledge about the contaminant) insisted that such an idea would only be considered if it were coupled with a strong information sharing component. We supported that in Japan and at the 3 day Working Group (chaired by the US) which developed a draft this past March, believing that - **since contamination will occur, countries and NGOs are much better off knowing about the situation** than being in the dark.
(6) The Annex as finalized is significantly circumscribed and will offer us important new information:
* **It retains every Member's absolute right to ban contamination;** this guideline will not force any country to abandon its standards.
* It applies **only to GMO contaminants that have been assessed under the Codex Principles in any country;**
* At the WG meeting in DC that drafted the document, I specifically goaded the chair, Eric Flamm of FDA, into admitting that **US approvals would NOT qualify for this Annex** since they did not fulfill the Codex Principles. I also raised that point obliquely in Japan (referring to the 'country which is the largest producer and exporter') and all the delegates know it.
* **The information from that assessment will be put up on a publicly accessible website (the FAO 'Portal')** in summary form, but consistent with the formatting of the Principles; CBI will be respected, etc, but there will be information on contact points for the importing government to get all the info it wants.
* **Information on detection protocols will be included **(industry has refused to give these to even powerful European governments).**
* **The reduced or streamlined procedure is almost identical to all the steps in the full safety assessment in the Principles.**
* Codex clearly distinguishes 3 elements of risk analysis (it is somewhat artificial)-risk assessment, risk management, risk communication. All these documents deal only with risk assessment; **the determination of what is a 'low-level' so as to bring this Annex into play was decided to be a risk management issue and therefore not discussed.** In other words, each country is free to decide and a zero-tolerance policy is still OK (ie, 'low level' being defined as anything detectable).
Subject: GMW: Codex proposes guidelines for non-approved GMOs
GM WATCH daily list
1.Codex proposes guidelines for non-approved GMOs
2.Codex Task Force Report and Comments
EXTRACT: 'It is outrageous that instead of tightening up controls to prevent this contamination happening in the first place, the US is attempting to legalise such contamination. Governments must uphold European legislation which has a zero tolerance approach to unauthorised GMOs to ensure that consumers and the environment are protected.' (ITEM 1)
'From our perspective, regardless of whether this Codex guideline is approved or not, we will not eat GM foods, and [we - the Japanese Consumer Union - will] make every attempt to stop genetic modification of animals for food production.' (ITEM 2)
1.Codex proposes guidelines for non-approved GMOs
FoodNavigator, 5 October 2007
05/10/2007 - The Codex Alimentarius Commission is to create guidelines for assessing the risk of imported food made with non-approved genetically modified plant material, which would help relax trade barriers.
The EU currently applies a zero-tolerance policy for non-approved genetically modified organisms (GMOs) in food and feed imports. According to the Commission report, most of these GMOs have suffered delays in the approval system but have received regulatory approval in countries outside the EU or have a positive safety assessment from the European Food Safety Authority (EFSA).
Because of the differences in the GMO authorisation regimes between the EU and exporting countries, conflicting authorisations of GMOs have occurred. Codex said these could become more frequent and affect a greater range of crops in the future.
Codex establishes food standards, ensures fair trade practices in the food trade and promotes the coordination of all food standards work undertaken by international organisations on behalf of the UN's Food and Agriculture Organisation and World Health Organisation.
It has decided to advance a proposal that addresses the risk assessment of low-level presence of biotech plant materials, found in food or feed, which have been authorised in one or more countries but not yet in the importing country. This decision followed negotiations by members of the Codex ad hoc Task Force last week in Chilba, Japan.
Codex's proposal will be submitted to the Codex Commission next July for approval, and will subsequently be incorporated in the Codex Plant Guidelines as an annex including information-sharing mechanisms.
This system would not substitute the full food safety assessments under the Codex Guidelines for products to be marketed in an importing country. It will also not address risk management measures, so individual countries will need to decide when and how to use the guidelines within the context of their regulatory systems. No country would be obliged to adopt the document.
Codex's decision has been welcomed by European industry representatives, according to EuropaBio, the European Association for Bioindustries.
'The delays in approval of biotech products in Europe compared to the rest of the world as well the absence of a science-based approach to address low level presence is already leading to trade disruption and seriously impacting the supply of feedstuffs,' said Johan Vanhemelrijck, secretary general of EuropaBio.
'Moreover, this unresolved issue that bears no relationship with safety is having a damaging effect on public confidence towards biotech products. In light of the Codex decisions, we hope that the EU will revisit its zero tolerance policy towards low level presence, speed up its approval process and define the appropriate science-based approach so that European food and feed supplies are secured.'
Europabio says this issue should be addressed in a globally consistent way to ensure that all countries have an equal opportunity to trade food and feed materials freely with one another.
However, some have criticised Codex's proposals, disagreeing with only applying regulations to new foods merely because a certain technique has been used.
Henry Miller, a delegate to the task force in Japan, wrote in The Washington Times: 'It is one thing to regulate new foods with traits that are of potential concern, but quite another to regulate new foods merely because a certain technique has been used, especially when that technique is state-of-the-art and superior to its predecessors... Virtually everything in our diets has been genetically improved by one technique or another.'
Miller profile: http://www.gmwatch.org/profile1.asp?PrId=3D84
Organisations such as Greenpeace and Friends of the Earth are entirely against genetic modification. Clare Oxborrow from Friends of the Earth told FoodNavigator: 'We are concerned by attempts to legalise contamination of unapproved GM ingredients through Codex. The GM industry has failed to control contamination of the food chain, as last year's GM rice contamination incident highlighted.
'It is outrageous that instead of tightening up controls to prevent this contamination happening in the first place, the US is attempting to legalise such contamination. Governments must uphold European legislation which has a zero tolerance approach to unauthorised GMOs to ensure that consumers and the environment are protected.'
GM crops are increasingly cultivated in major crop exporting countries. The adoption rate of cultivating GM crops has seen double-digit annual growth since 1996. In 2006, 10.3m farmers in 22 countries cultivated biotech crops on 102m hectares. Ninety per cent of farmers who benefited from these crops were from developing countries, according to the commission's study.
2.Codex Task Force Report and Comments
By Yasuaki Yamaura
Consumers Union of Japan, October 3rd 2007
The Codex Task Force meeting on Biotechnology has ended and the current round of the discussions is over. Japanese consumers are concerned about the issues under discussion regarding food from GMO animals as well as the GM contamination problem.=20
During the Codex TF meeting held here in Japan, Consumers International stated its position that CI is against the use of antibiotic resistant marker genes in animals, and that they should not be allowed. In fact, the current Codex language on the controversial marker genes is already five years old, based on science that is even older. Japanese consumer delegates feel strongly that all antibiotic resistant marker genes should be banned totally.
The current text for animals is similar to the guideline for plants. We feel even more strongly that in the case of animals, there are ethical considerations that must be taken into account. The fact that 'Other Legitimate Factors' (OLF), such as ethical concerns, environmental issues and animal welfare problems are not clearly mentioned in the text is a very big problem. Any attempts to refer OLFs to be dealt with by other international organizations are also insufficient as we have no idea about their willingness or capability in this field.
Another topic was a text about foods modified for 'nutritional and health benefits'. We were especially watching how Codex would deal with foods engineered for a health concern, in case the food is also lower in other nutrients. In case a GM food is promoted as having health benefits, consumers may be misled to eat a less healthy diet based on false and misleading claims. In addition, it is likely that unintended or unexpected effects will occur. Terms such as 'nutritional disadvantage' or 'nutritional risk' were suggested, but finally, the term 'adverse nutritional effects' was agreed upon by the delegates, and the Codex language is as follows:
When evaluating the exposure, it is appropriate to consider information on whether the composition of the modified food could lead to adverse nutritional effects as compared to consumption of the food that it is intended to replace.
Finally, the biggest issue of the entire Codex TF meeting: How should countries deal with normal foods that have been contaminated with GM traits? We feel that this issue should not be covered by Codex at all. Each importing country should be able to make its own rules without fear of a WTO challenge.
The United States and other food exporting countries have tried to water down the proposals at previous meetings, but in the end, countries agreed to language that in some cases should make it possible for importing countries to control GM contamination.
For example, if a US company accidentally exports soybeans that are found to be contaminated with Roundup Ready soy, then the importing country can ban the import and made sure such foods are not sold to consumers. Since this only applies to GM traits that have been approved, countries can actually apply their own rules to crops such as Bt10 corn or LL601 rice. Since they have not been approved in any country, they are not covered by Codex standards or guidelines, which means importing countries will not face a WTO challenge if they stop the import.
Interestingly, since the United States only has a sloppy 'voluntary safety consultation' system for GM crops, foods from the US can still be banned if they are found to be contaminated with low levels of GM traits. An important victory is that countries should be able to access a database with detection method protocols and DNA reference material. This is a key point when dealing with GM contamination, but we feel that the data that will be made public is probably going to be very limited. For example, biotechnology companies are already limiting access to a large amount of data on genetic modification that they claim is industrial secrets.
There will not be a fourth meeting of the Codex TF since all the documents could be completed, and they will be sent to Codex for approval (at Step 5/8). From our perspective, regardless of whether this Codex guideline is approved or not, we will not eat GM foods, and [we will] make every attempt to stop genetic modification of animals for food production.
Tokyo, Japan October 3, 2007