Select Committee on European Communities Second Report



Differences between the US and EC regulatory approaches

44.  The United States is the major user of commercial applications of modern biotechnology[89] with 27.8 million hectares of genetically modified crops under cultivation in 1998[90]. It is also the largest commodity crop exporter. The United States has regulated biotechnology in a very different manner to the approach taken in Europe. While the regulators in both systems ask similar questions, the United States takes an optimistic approach ("Why not?")[91] whereas Europe is more pessimistic and involves predicting the unexpected ("Why?").

45.  Unlike the European Community, the United States government decided that existing laws could be used to ensure the safe use of genetically modified organisms[92]. "The United States believes that the new techniques of genetic engineering are an extension of biotechnology in general and, thus, new products developed through these techniques are extensions of existing product classes."[93] The United States' process has operated more efficiently than that in the EC as the Community has to reconcile 15 different Member States' approaches to the technology and 15 different regulatory structures. The United States' application of existing laws has also resulted in much greater clarity and speed in the implementation of controls on GMOs.

46.  In the United States, there is no special regulatory system for ensuring the safe use of biotechnology in the laboratory or factory where the organism is not to be released into the environment[94]. The National Institutes of Health (NIH) have special guidelines[95] for laboratory or factory use that are implemented by most users of the technology. If an organism is to be released into the environment, then there may be three agencies which have oversight: the Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The USDA, through the Animal and Plant Health Inspection Service (APHIS) is the lead regulatory agency for deliberate releases of genetically modified plants into the environment.

47.  The information required for assessing or assuring the safety to human health and the environment under Directive 90/220/EEC and by the USDA appear to be almost identical and it is generally agreed that the assessment procedures result in very similar conclusions. In reality, most field trials in the United States are however only subject to notification, not assessment[96]. As a general principle, in the United States, the transfer of genes to plants which are not significant in agriculture is only important if there is a likelihood that the genes will cross back into the agricultural (managed) environment. APHIS's stated aim is not the protection of the environment but the protection of American agriculture[97].

48.  The European regulatory system for releases into the environment requires a complete risk assessment to be performed by the applicant (and so differs from those countries (such as the United States and Canada) where government performs the assessment on the basis of information supplied by the applicant). The competent authority in the Member State applied to then audits the application to ensure that risk to human health and the environment has been minimised. In the United Kingdom, advisory committees have been allotted the role of examining the risk assessment and management procedures in applications and of advising Ministers or the Health and Safety Executive on whether to permit the genetic modification work to proceed and on any changes to the procedures that might be required to minimise risk. In the case of GM foods, the Government perform the risk assessment on the basis of information provided by the applicant.


89  Though figures are not available for China. Back
90  Of which 71 per cent. was herbicide tolerant (New Scientist, 31 October 1998 (No 2158), p 46). Back
91  Professor Beringer, Q 21. Back
92  This policy was published as "Co-ordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public comment", Federal Register, 1986. Back
93  United States Department of Agriculture, p 169. Back
94  Regulations made by the Occupational Health and Safety Agency, however, concerning general factory safety apply to biotechnology. Policies were made concerning the interpretation of these regulations in the light of the use of recombinant techniques, under the Co-ordinated Framework and published in the Federal Register at 50 FR 14468 (1985); 51 FR 23302-50; and 51 FR 25412 (1986). Back
95  The latest amended version (30 April 1998) of the current NIH Guidelines can be found in the Federal Register at 63 FR 26018. Back
96  Food and Drink Federation (FDF) Q 545. Back
97  APHIS provides a mission statement on the Internet at http://www.aphis.usda.gov/oa/mission.html. APHIS also has a wildlife services section, but this is not concerned with the impact of agriculture on the environment as opposed to the prevention of wildlife damage to crops and the protection of rare and endangered species. Back

 
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