Application of Regulations
Risk Assessment and Characterization


Application of Regulations
Risk UK Focus
Risk US Focus

Are Risk Assessments universally valid? EU/US comparison, perspectives.

At the one end of the scale, one that has caused considerable problems to Europe over the last few months, and which will continue to provide real problems, is as follows. Suppose the EU approves an organism as completely safe for use within the European Union, whether it is anywhere in the geographical confines of Europe or restricted to 'cold' climate agriculture (for example).

We have made this product and obviously want to sell it as widely as possible -others have their own legislation relating to the use of such organisms, and may not be happy with our safety assessment; can they stop us marketing our 'product' because of safety concerns? What weight should our safety assessment play in their consideration of the safety issues? Our permission to market the product may be just as valid as their decision not to allow marketing of the product, perhaps because of indigenous organisms. How do we guard against protectionism cloaked within safety concerns? In the case of a developing country, where there might not be legislation that governs biosafety, should we simply export to them without considering the risks that our organism might pose to them? If so, are we prepared to face the risk that a slightly 'more' modified organism returns to haunt us?

What about the opposite problem, where the EU receives biological products from other countries. We may know that it has been modified if it has come from the USA or Canada, but if it comes from countries which have no legislation in place to allow for the assessment of risk associated with modified organisms? How likely is it that their products will appear on our markets and pose problems for us in the future.

Within the European Union there are two directives that cover this part of Biosafety. Both directives were drafted in 1990, and required implementation within member states by 1993. 90/219 governs the contained use of genetically modified micro-organisms, whilst 90/220 governs both the release of the organisms into the environment and the marketing of any modified organism, whether for release of for contained use. The primary difference is that 90/219 assumes containment, and that the regulatory structure can be specific for the member state. 90/219 sets minimum standards for the making, use or keeping of the organisms, and member states are free to have legislation that extends both the range and scope of the directive. In the UK the legislation covers all organisms, not only micro-organisms. Release is different, for even an experimental release has the potential for crossing the boundaries between states, and therefore, the harmonisation of community legislation is important. The marketing of modified organisms is also likely to be community-wide, even though geographical constraints may be applied. 90/219 is therefore global, and must be implemented 'as is' within the community, without allowing real discretion in member countries.

These directives have been criticised by many, for a multitude of reasons: perhaps the most important reason (not usually stated) is that they appear to be different from that which has been implemented in the USA. There are major problems with both directives.

It was always intended that the directives would change with time, in that the authors wrote into it that product specific legislation could exempt a particular substance from consideration as long as the risk assessment procedure in the specific legislation was at least as comprehensive as that identified in 90/220. It was also assumed that it was based on a presumption of a learning curve, that each case would be argued on its merits, but taking into account evidence and information obtained from previous releases of similarly modified organisms. Hence the legislation allowed for the institution of simplified procedures - or 'fast-track', where consent to release the modified organisms could be given much more quickly and easily than for a totally unknown construct. There are therefore, no major changes expected in this Directive, as most desirable changes (as far as industry is concerned) can be accomplished by product-specific legislation or through fast-track procedures. We remain different from the United States in many important respects.

Are there differences in the way in which containment is handled in different countries?

There are significant differences in the containment requirements in different countries. Although both the United States and the United Kingdom developed their regulatory systems following the moratorium self-imposed by scientists in the 1970's, the regulatory systems moved apart significantly. In the United States it was decided not to impose new regulatory burdens on the biotechnology laboratory or industry. Guidelines for the safe use of modified organisms in laboratories were introduced, in particular the NIH Guidelines, which imposed a set of safety precautions on those projects funded by the NIH for the safe use of modified organisms. Most industries, although not funded by NIH, followed these guidelines, at least in spirit.

In Europe, however, a statutory regulatory system is in force, which requires an assessment of the risks associated with the use of modified organisms in containment. The statutory system in Europe also depends on a Directive (90/679) which defines the conditions in which biological agents (whether genetically modified or not) may be used in the workplace.

Thus evaluating levels of hazard and exposure requires risk assessors to consider potential adverse effects. The level of scrutiny will depend upon how well known the GEO is and the extent to which it has been genetically manipulated. The US National Academy of Sciences and an independent group of scientists have characterized this criterion in terms of the organism's "familiarity." Many other workers, national and international groups have described the process of risk assessment in general and as related to GEOs in particular. The National Academy of Science, in two separate reports stressed the importance of familiarity - the amount of background information available about the parent organisms and the host (i.e. the GEO). In their view, there is a risk continuum. On one end of this continuum are easily contained, well understood host organisms such as cows with introduced bovine growth hormone. At the high risk end are less well-known, less easily controllable organisms such as microbes engineered for bioremediation.

It is clear that the more information available about the parent and GEO microorganisms, the greater confidence one can have when predicting the behavior and overall effects of the GEO. One can dissect this general statement into a series of attributes to consider and discussed the need for more scrutiny when less information is available about any particular attribute. Thus, if the phenotypic characteristics of the host microorganisms are well known and the inserted DNA is well characterized and/or from a closely related species, less concern is generated and a lesser degree of scrutiny is required. The specific information requirements (e.g. how detailed the description of the organism or method of DNA insertion should be), however, need be described only in very general terms.

Last Modified: June 12, 2001
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