CODEX TASK FORCE COMPLETES THREE BIOTECH GUIDELINES

A set of new international guidelines related to biotech products have recently been agreed, potentially facilitating trade in cases where trace levels of genetically modified material is found.

The Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology, at its meeting in Chiba, Japan, from 24 to 28 September, agreed to forward three guidelines for the conduct of food safety assessments to the next of the Codex Alimentarius Commission for adoption. These guidelines are intended to help countries assess the risk of: imported food containing low levels of non-approved genetically modified (GM) plant material; foods derived from biotech animals; and foods derived from biotech plants modified for nutritional or health benefits.

The European Union - which generally takes a cautious approach to biotech, as opposed to pro-biotech countries such as the US - agreed to the new guidelines on the food safety assessment of foods with a low-level presence of biotech plant material on condition that an effective system for data and information sharing would be set up. The EU currently applies a zero-tolerance policy for non-authorised genetically modified organisms (GMOs) in food and feed imports. The new Codex guideline is set to help reduce trade barriers.

Guidelines on the safety assessment of trace levels of GM plant material

The Codex Biotech Task Force agreed in December 2006 to elaborate guidance on food safety assessment of foods derived from GM plants in cases where those plants have already been authorised in one or more countries for commercialisation for food use, and are unintentionally present in low levels in food in countries in which the GM plants are not authorised due to imports (see Bridges Trade BioRes, 15 December 2006, http://www.ictsd.org/biores/06-12-15/story2.htm). A working group, chaired by the US and co-chaired by Germany and Thailand, was established to draft guidance on this issue in the form of an annex to existing guidelines on the safety assessment of biotech foods (see Bridges Trade BioRes, 11 July 2003, http://www.ictsd.org/biores/03-07-11/inbrief.htm).

The meeting in late September in Chiba completed the draft annex, and forwarded it for adoption by the next session of the Codex Commission.

The annex describes the recommended approach to food safety assessment in situations of low-level presence of GM plant material in food, or for advance preparation for such circumstances. The annex also describes data and information-sharing mechanisms to facilitate the use of the annex and to determine whether it should apply. However, the annex does not address risk management measures, nor prevent national authorities from conducting a safety assessment according to the Codex Guideline on plant biotechnology. It does not eliminate the responsibility of industries, exporters and national competent authorities to continue to meet countries' relevant import requirements, including in relation to unauthorised GM plant material.

The document can be applied under two different scenarios. The first situation involves trace levels of unauthorised GM material intermixed with commodities such as grains, beans or oil seeds, meaning that the unauthorised material would be diluted. Individual servings of food containing the commodity would contain low levels of material derived from GM plant varieties. In the second situation, the exposure would be to foods consumed whole or diluted - such as fruits and vegetables including potatoes, tomatoes or papaya - meaning exposure would be rare, but could be to an undiluted form of the unauthorised GM plant material; An entire unauthorised fruit or vegetable might be consumed.

At the meeting, the EU stressed that it could agree to forwarding the annex for adoption at the next Codex Alimentarius Commission on the condition that an effective system for data and information sharing was put into place. The annex text now states that countries should make requisite data and information available to a publicly accessible central database. At the request of the EU delegation, the Biosafety Clearing House of the Cartagena Protocol and/or Organisation for Economic Co-operation and Development (OECD) BioTrack Product Database could be used in certain cases to provide important information to regulating authorities. Some countries did not support this reference, including for the reason that not all Codex members are party to the Cartagena Protocol or the OECD, and the Cartagena Protocol addresses living modified organisms only.

The annex also requests that Codex members make available, to the central database, detection method protocols and reference material suitable for situations of low-level presence of GM material.

The 31st Session of the Commission, which is set to adopt the new guidelines, will be held in Geneva, Switzerland, from 30 June to 5 July 2008.

Clare Oxborrow from Friends of the Earth expressed concern over the new guidelines. "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 years 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," she said.

The European Association for Bioindustries, EuropaBio, on the other hand, welcomed the agreement on the new guidelines. "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," he added.

Agreement on antibiotic resistance marker genes

The Codex Biotech Task Force agenda also includes GM animals. As a step towards agreeing on draft guidelines for the conduct of food safety assessments of foods derived from GM animals, the Task Force agreed in 2005 to forward questions formulated by member states about "marker and reporter genes" to FAO and WHO for scientific advice (see Bridges Trade BioRes, 15 December 2005, http://www.ictsd.org/biores/06-12-15/story2.htm). Some Codex members, such as the EU, and civil society groups such as Consumers International, have expressed concerns regarding the safety of antibiotic resistance marker genes. Such marker 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. Marker genes are rarely used in animal biotechnology.

The Task Force finally agreed to maintain the section on the use of antibiotic resistance marker genes unchanged since the report of the FAO/WHO joint expert consultation, which took place in March, had not brought any new scientific evidence that would justify the need for additional or different provisions. The Task Force agreed to forward the proposed draft guidelines for adoption by the 31st Session of the Commission.

The draft guideline for the conduct of food safety assessments of foods derived from biotech animals directly copies the GM plant guideline. The text says that alternative technologies to antibiotic resistance marker genes should be used in the future development of animal biotechnology. Also, the factors to assess the safety of foods containing antibiotic resistance marker genes should be the following: a) the clinical and veterinary use and importance of the antibiotic in question; b) whether the presence in food of the enzyme or protein encoded by the antibiotic resistance marker gene would compromise the therapeutic efficacy of orally administered antibiotic; and c) the safety of the gene product. The section finally says that if the presence of the antibiotic resistance marker gene or gene product present risks to human health, the marker gene or gene product should not be present in food.

GM plants modified for nutritional and health benefits

The Biotech Task Force also agreed to forward a proposed draft annex on guidance for the safety assessment of foods derived from GM plants modified for nutritional or health benefits to the 31st Session of the Codex Commission. The proposed annex has been redrafted by a working group led by Canada, and co-chaired by Argentina and New Zealand.

The proposed annex defines the factors determining a GM plant as modified for nutritional or health benefit as the following: a) the GM plant "exhibits a particular trait in a portion of the plant intended for food use"; and b) the trait is a result of the introduction of a new nutrient, or alteration of either the quantity or bioavailability of a nutrient, removal or reduction of undesirable substance such as allergens or toxicants, or alteration of the interaction of nutritional or health relevance of these substances.

The draft annex says that foods derived from GM plants modified for nutritional or health benefits may benefit certain populations/sub-populations, while others may be at risk from the same food. The food safety assessment is intended to identify new or altered hazards relative to the conventional counterpart.

Background

While Codex standards are only voluntary, the Codex Alimentarius Commission is recognised by the WTO 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.

Additional information

The report of the Biotech Task Force meeting is available at http://www.codexalimentarius.net/web/archives.jsp?lang=en

ICTSD reporting; "Codex Proposes Guidelines for Non-Approved GMOs," FOODNAVIGATOR, 5 October 2007.