Biotech industry wins some concessions on GMO rules

The Government has rejected assertions in a report by the House of Lords Select Committee on Science and Technology that excessive regulation has placed the UK's biotechnology industry at a competitive disadvantage. But its response shows that an increasing number of deregulatory moves are now in place or in the pipeline.1

The Lords Committee reported last year. It broadly concurred with the biotechnology industry's view that the risks of genetically modified organisms (GMOs) had been over-estimated by regulators (ENDS Report 225, pp 22-25 ).

In its response, the Government says that it takes "very seriously" the complaint about "perceived" differences in the relative stringency of controls in the UK and competitor countries, notably the USA and Japan. But it rejects the Committee's conclusion that regulation of genetically modified organisms (GMOs) is more flexible in the USA than in the UK. In fact, it claims that the inquiry failed to examine UK regulation at all in its "comparative analysis" of legislation in OECD countries.

The Government adds that a new "fast-track" procedure for processing applications for the deliberate release of GMOs into the environment was in the pipeline before the Lords' inquiry (ENDS Report 222, pp 38-39 ). This ensures that "the time taken to issue licences to carry out work is now the same in the US and the UK, but the Government believes the UK system is more easily adapted to change with accumulating experience."

The Government accepts that, given the rapid growth in both the contained use and deliberate release of GMOs, the two EC Directives covering these activities appear dated. However, it points to the in-built mechanisms for adapting them as experience accumulates, and says that these are being activated where possible.

The first tranche of GMO releases qualifying for fast-track approval were announced in a guidance note issued in January.2 The procedure allows for the approval of "low-hazard and low-risk" GMOs without referral to the Advisory Committee on Releases to the Environment (ACRE) on the basis of ACRE's generic advice for groups of organisms. The Government expects "a significant proportion" of crop plant releases to qualify for fast-track approval.

Further official guidance issued in April pares down the information requirements for releases of genetically modified plants.3 The move is seen as an interim measure until agreement is reached to make the technical annexes of the EC Directive on deliberate release of GMOs more organism-specific, in line with one of the Lords' recommendations. The first such annex, specific to crop plants, was agreed at EC level in February and the UK regulations will be amended in due course.4In another deregulatory move, the UK has submitted a proposal to the European Commission which would allow the release of more than one genetically modified arable or forage crop species at more than one site to be covered by a single consent.

The Select Committee also attacked the Directive on contained use, describing its classification of pathogenicity and scale of activities as the basis of risk assessments as "fundamentally unscientific." The report argued that, except where pathogenic GMOs are being used, existing guidelines on good laboratory or industrial practice provide sufficient safeguards.

In its response, the Government says that "environmental protection is an important consideration in evaluating the safety of GMOs in contained use because of the possibility of escape". It concedes that relatively little is known about these risks. However, it goes on to concur with one of the Committee's key points, saying that "it now appears clear that much of the work with GMOs in containment poses little or no risk to the environment".

The regulations for activities not involving pathogenic GMOs do not, the Government points out, require physical safeguards beyond those provided by good laboratory or industrial practice. However, industrial processes currently require advance notification. The Government is pressing the European Commission to relax the procedures for non-pathogenic GMOs to involve simple notification of the start of work and annual returns of work in progress.

One of the fundamental debates during the Lords' inquiry concerned the control of products made using biotechnology. Industrialists claim that the technology is no more risky than other production methods and does not warrant a second, "horizontal" layer of controls. The Government says that it "has pressed consistently for product Directives to cover GMOs and the need to avoid dual notification under process-based and product-based legislation."

Two Directives have been adopted over the last year that fulfill this requirement, covering the authorisation of medicinal products and products used in animal feedstuffs.

Finally, the Government takes issue with the Committee's belief that "biotechnology products will ultimately gain public acceptance because they are desirable and reliable." Its response argues that public acceptance will hinge on the success of products in the marketplace - but "it is by no means a foregone conclusion that such products will automatically be commercially successful...An open, straightforward stance by industry will do much to influence public confidence."

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