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.
