CODEX: DISCUSSIONS HEAT UP ON ANIMAL BIOTECHNOLOGY STANDARD

At a meeting of the Codex Alimentarius Commission Working Group on Safety Assessment of Foods Derived from Recombinant-DNA Animals held on 30 May - 1 June in Brussels, delegates struggled to define the unique challenges posed by animal biotechnology and how, in particular, to take up non-food safety concerns such as environmental risks, animal welfare and ethical issues. Under a mandate from the Codex Intergovernmental Task Force on Foods Derived from Biotechnology, Codex members have been developing draft guidelines for the conduct of food safety assessments of foods derived from genetically modified (GM) animals (see Bridges Trade BioRes, 30 September 2005). Although the draft guidelines are based on text adopted in 2003 for GM plants, there are particular differences in the animal case and non-food safety issues that some countries argue need to be taken into account in the new standards.

Consideration of "legitimate factors" for biotech regulation

Delegates split into two groups regarding how to take into account factors that could influence government decision-making on animal biotech that are outside of the Working Group's mandate. While the group is mandated to only address human health and food safety issues, the Intergovernmental Task Force was told over five years ago to explore how Codex should address "other legitimate factors" influencing biotechnology decision-making. Disagreement on what kinds of socio-economic and environmental issues could be included in this definition, and whether and how Codex should mention them, prevented any mention of these issues in the GM plant standards adopted in 2003. Now, however, the EU would like an explicit recognition of countries' rights to address some of these concerns in laws crafted to regulate animal biotechnology.

The language in question is in paragraph two of the "scope" section of the draft text and the five different versions proposed at the meeting would each say that the listed factors could be dealt with by "other bodies". As such, the different versions of the text do not include the factors as food safety concerns within the scope of the guidelines, but rather recognises their legitimacy as non-food safety issues to varying extents. Such language could be used by governments, in the case of a WTO dispute, as proof that an international standards-setting body acknowledged that countries could incorporate measures to address those issues in their biotech regulations.

The US would like to include text that "recognises" that the factors "are being or may have to be" dealt with by other bodies, and includes in its list of factors animal welfare; safety of food derived from GM animals intended to be used for non-food purposes; environmental risks related to environmental release of GM animals; and the safety of animals fed from GM feed.

The EU, on the other hand, would like stronger language supporting the issues. Its favoured text would say that the issues play an important role and as such should be addressed in other bodies -- and includes the term "legitimate factors" as undecided language. In addition to the four factors listed by the US, it would also include ethical, moral and socio-economic effects of GM animals. They argued that given that GM animals have attracted even more public attention and concern than GM plants, governments should be given the explicit authorisation from Codex as an international standard-setting body to take into account moral, ethical and other public concerns regarding animal biotech. While acknowledging that the guidelines would not address these concerns, the EU text would allow countries to take into account non-food safety concerns in their biotech regulations.

For its part, Argentina put forward text that closely echoes that adopted in the GM plant guideline, referring only to "animals fed with GM feed or GM feed itself" and environmental risks. Another option would say simply that the guidelines address only food safety and nutrition, and do not address the four points listed by the US. A compromise text proposed by the US after intense negotiations with the EU and its supporters would have preambular language saying that the issues "raise concerns and without prejudice to their legitimacy or importance" they would be dealt with by other bodies.

Animal-plant differences taken up

Other issues discussed include antibiotic resistance marker genes (ABRMG), where talks built upon the first meeting of the group in February of this year. These genes are inserted in the modified organism to identify genetically transformed plants; i.e. only plants with the marker gene will grow on material that contains antibiotics. Some fear that these genes may be transferred into bacteria in the stomach, thereby making potentially harmful bacteria resistant to antibiotics.

The draft text copies directly from the GM plant guideline, which sets out food safety factors to be considered in regulating ABRMGs. It also says that alternative technologies to ABRMs should be used in the future development of GM animals when those technologies are safe. Most countries at the meeting lobbied for cutting the section on ABRMGs entirely, arguing it was not necessary because ABRMGs were rarely used in animal biotechnology. Others, including the EU and Consumers International, wanted the text dropped because they did not think ABRMGs were safe and as such did not want rules to be included that would support their usage. Following an impassioned plea from Canada regarding the need for international standards for ABRMGs for animals, though, delegates decided to hold an expert consultation on the issue. In addition to considering marker genes, the consultation will, based on a request from Kenya, look into the safety of food from animals that have been subject to GM treatments like vaccines for rinderpest, which have widespread use in Africa (known as "non-heritable constructs").

Delegates also agreed to re-open negotiations on an annex to the guideline which describes legitimate measures to address GM allergenicity concerns. Although the annex in the draft GM animal guidelines was taken from the GM plant guidelines, Argentina suggested that given new scientific information it was time to re-open talks and re-negotiate the language in both documents. Norway, Brazil and Argentina are expected to table draft text on allergenicity at the next meeting of the group in September 2007. At that time, delegates are also expected to discuss concerns from Norway that certain genetic modifications, such as "cry" sequences used in many GMOs, can over stimulate immune systems with human health impacts.

The next meeting of the Codex Intergovernmental Task Force on Foods Derived from Biotechnology will be held in November 2006 in Chiba, Japan.

Background

While Codex standards are only voluntary, the Codex Alimentarius Commission is recognised by the SPS Agreement as the international organisation responsible for standard-setting related to food safety. WTO Members "shall base" their measures related to human and plant health on Codex's standards, guidelines or recommendations. Such measures "shall be deemed to be necessary to protect human, animal or plant life of health, and presumed to be consistent with the relevant provisions" of the SPS Agreement. The other two international standard-setting body recognised in the SPS Agreement are the International Plant Protection Convention (IPPC) for plant health and the Office International de Epizooties (OIE) for animal health.

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