While the FDA rules on premarket notice and labelling for GM foods have come under fire for not protecting consumers in the US, the EU is gearing up for further debate on the reform of its own Directive on the subject. The International Centre for Trade and Sustainable Development (ICTSD)  updates the current policy situation in both regions.

The US Food and Drug Administration (FDA) released its proposed rule on premarket notice and draft guidance on labelling of bioengineered foods in January. Despite receiving a flood of comments supporting mandatory labelling of GMOs, the FDA opted for voluntary rather than mandatory guidelines for labelling of genetically modified organisms (GMOs). The US move, which follows the recently completed conciliation process between the European Parliament and Council regarding amendments to Directive 90/220/EEC, will do little to mend the transatlantic rift between the EU and US regarding the EU’s de facto moratorium on the approval of new GMOs.


The FDA’s proposed rule on “Premarket Notice Concerning Bioengineered Foods” would require GM food producers to notify the FDA at least 120 days prior to the commercial distribution of plant-derived bioengineered foods intended for human or animal consumption. The notification would need to be accompanied by information on, inter alia, the method of development; any newly inserted antibiotic resistance marker gene (ARMG); and the substances introduced into or modified in the food, including safety considerations associated with them. Information submitted to the FDA and its response would be posted in the agency’s electronic reading room unless deemed confidential. The FDA has also issued a draft guidance document to assist manufacturers who wish to voluntarily label their foods (human and animal) as being made with or without bioengineering or the use of bioengineered ingredients in order to ensure that labelling is truthful and not misleading.


The proposed rules have come under heavy criticism from consumer and environmental groups who claim that the provisions fail to adequately protect human health and the environment. In particular, many have expressed their anger that the FDA did not accommodate the widespread public demand for GM food labelling. Others have criticised the FDA rule for not requiring any mandatory testing of GM foods, but rather placing the burden of proof largely on those companies that wish to market their products as “GM free”.


EU revision of Directive 90/220/EEC


Efforts to reform regulations related to GM foods are also underway within the EU, in particular with regard to the EU “Council Directive on the deliberate release into the environment of genetically modified organisms” (90/220/EEC). In December 2000, the European Parliament and Council concluded a conciliation procedure on GMOs that had been initiated after the Council refused to accept the Parliament’s 29 amendments to the Directive in April. This agreement will now be submitted to the plenary for ratification in February. It is unclear, however, whether the new directive will end the de facto moratorium that currently exists in the EU on the approval of new GMOs.


Amongst other provisions, the revised Directive calls for the phasing out of antibiotic resistance marker genes for GMOs placed on the market by 31 December 2004 and for experimental GMOs possibly by 31 December 2008. The EU action is seen to be a precautionary approach to ARMGs, since no clear evidence regarding their health impacts currently exists. The FDA, in contrast, does not provide for the phase-out of ARMGs, but only proposes that newly inserted ARMGs are specified. According to the FDA draft guidelines on the use of ARMGs released in 1998, “the presence in food of proteins encoded by antibiotic resistance genes is not of great concern”, nor does the potential transfer of antibiotic resistance to cells lining the gastrointestinal tract “raise a safety concern”. It remains to be seen if the US will challenge any EU provisions that mandate the phase-out of ARMGs.


EU working paper on traceability and labelling


At the end of last year, the European Commission issued a working document on traceability and labelling of GMOs and products derived from GMOs that outlined various options regarding traceability and labelling and invited Member states to provide their own views and experience. The document also outlined the Council’s Common Position on amending Directive 90/220/EEC (adopted on 9 December 1999), which proposed that Member states should take measures to ensure traceability at all stages of the placing on the market of GMOs. These provisions would also apply to imports, in that products containing and/or consisting of GMOs cannot be imported into the Community if they do not comply. Regarding labelling, the Council’s Position required that the labelling and packaging of GMOs placed on the market in products or as products must state that a GMO is present, either on the label or in an accompanying document. According to EU sources, the Commission is expected to submit proposals on new legislation for traceability by the end of March and for labelling by June.


To view the proposed FDA rules on bioengineered foods visit:
http://vm.cfsan.fda.gov/~lrd/biotechm.html
The FDA draft guidance on ARMGs is available at:
http://vm.cfsan.fda.gov/~dms/opa-armg.html
The European Commission Document on traceability and labelling is available at:
http://europa.eu.int/comm/food/fs/biotech/biotech01_en.pdf


“Biotech Foods Rule Fails to Protect American Public,” ENVIRONMENT NEWS SERVICE, 18 January 2001; “EU close to agreement on new genetic crop law,” REUTERS 13 December 2000; “GMO conciliation nears end,” NEWS REPORT EUROPARL, 13 December 2000; ICTSD Internal Files.


Original article appeared in BRIDGES Weekly News Digest, Volume 5, Number 2, 23 January 2001 (www.ictsd.org). Article reprinted with the kind permission of International Centre for Trade and Sustainable Development (ICTSD).