Examination of Witness (Questions 200
WEDNESDAY 17 JUNE 1998
200. May I move on to my question which
looks at the question of monitoring, particularly the monitoring
of GM crops after commercial consent. This is something that you
argue for. How do you see this actually happening in practice?
What would you be monitoring, measuring? How would you set the
standards of measurement that allowed you to decide that it was
a good thing or a bad thing?
A. The key principle
of monitoring is that we should be able to revisit the key assumptions
made in risk assessments when a crop is given commercial consent.
At the moment, the few crops which have been given commercial
consent are going ahead on the basis that we have a certain level
of confidence that they will only cross-hybridise with wild relatives
at a certain rate, or the genes will only persist in volunteer
populations of the crop at a certain level. Now, all of those
are assumptions based on a body of scientific knowledge about
natural selection and the movement of genes. They are not judgments
based on any kind of empirical data on the large-scale growing
of this kind of crop, precisely because they have not been cleared
for commercial use before. So we are assuming certain things will
hold true when these crops are grown on a large scale, based on
key scientific assumptions and a small set of empirical data from
field trials. Now, it seems to me sensible that when crops are
grown on a commercial scale, to revisit those assumptions to see
if they hold true. Things like hybridisation with wild relatives
and persistence of genes are measurable. It is difficult to set
up the experimental protocols which would do that measuring accurately
and to people's satisfaction but it is not impossible, in my view.
We should be able to come to an agreement between the scientific
community, the industrial community and the organisations who
have an interest in the environmental impacts, on actually what
we should measure: what is important and how to do it. I do not
have ready answers to that as yet. The Green Alliance is organising
a workshop later on this year with scientists and with non-government
groups to discuss precisely that: what could be feasibly and usefully
measured? We must make some effort to check our assumptions. Otherwise,
it is like conducting a huge uncontrolled experiment without any
means of checking the result.
201. Who do you think would be responsible
for doing this and where would the cost fall?
A. That is also
a matter for considerable debate. I think there is probably a
mixture of responsibility for Government, for the industrial interests,
and possibly also for the farming community. When I say "responsibility"
I do not just mean cost responsibility but broad responsibility.
I do not want to prejudge that. I hope we can find some feasible
agreement on that; about what is the right allocation of responsibility.
202. Is there a role for Government in requiring
or assisting the segregation of GM products down the food chain?
A. I should stress
that our primary interest is environmental rather than food and
consumer choice. Nonetheless, I do believe in consumer choice.
I am not sure our Government could unilaterally require segregation
of crops coming in from abroad but I think it should certainly
encourage it. On a United Kingdom basis, our Government should
at least require traceability which is a first step towards segregation.
What I mean by that is that it should be a requirement to record
where GM crops are grown. That kind of traceability would enable
segregation by growers and processors and retailers, if they wanted
it, but would also enable environmental traceability, if you like.
If we are going to go in for any meaningful monitoring, at least
we have to know where GM crops are being grown.
203. Is that feasible internationally or
only within a single country?
A. I think it
is only feasible internationally if individual countries are prepared
to require it, or if agreement can be gained at a European level
to ensure monitoring. Obviously, ideally, in most of my comments
it is implied that we would be doing this across Europe. We would
be improving the control of the technology across Europe, but
in the absence of agreement in Europe I am sure the United Kingdom
Government can take steps here.
204. Miss Hill, you appear to be satisfied
with the transparency of the operation of United Kingdom regulation,
although not with the degree of public awareness. In your note,
in paragraph 13, you welcome some of the new moves made in Europe,
but you indicate that in Europe also you would like to see greater
transparency. What further changes would you like to see?
A. The draft
revision of the Directive does put in place some better provisions
for public access to information. Previously, it only required
a very small set of information to be released by each Member
State and, therefore, the extent to which Member States did provide
information varied enormously from quite a lot in the United Kingdom
and Netherlands, to almost none in some other countries. The recent
revision allows for the Commission itself to provide summaries
of applications for marketing consents, which are clearly the
ones that tend to attract the most interest, but they are only
proposing to allow 30 days for comment which is probably, on the
United Kingdom experience, not long enough. Something like 60
days would be more realistic. There is also a new provision for
assessment reports, which is a kind of summary evaluation of an
application for marketing made by the Member State competent authority
to which the application is first made. Our disappointment about
that is that the Commission is only proposing to release the assessment
reports after a decision has been made, which I think is definitely
unhelpful. In fact, it is almost less helpful than not releasing
any information at all, for people to feel that they can only
get something once a judgment is finalised. My other anxiety about
the Brussels system is the increasing use of central scientific
advice. There are now committees set up in Brussels, under the
auspices of DG XXIV, which have been called upon, in effect, to
be the final arbiters on applications for marketing consents,
where there have been disputes between Member States as to whether
they should go ahead. This to me is damaging to the democratic
accountability of the EU system, because each application goes
through a scientific evaluation process in the Member State which
is, at least to some extent, (certainly in the United Kingdom),
accessible in the sense that one can see when the application
is coming up for discussion. This is because agendas are published
now. One would be able to get reports of the meetings and obtain
copies of the dossiers from the Public Register. It seems to me,
for the Brussels-based committees, that this is much further removed.
One could pay a lot of attention to the scientific judgment process
in the United Kingdom, for instance, and then a completely different
judgment is made in Brussels. It seems, as yet, very unclear whether
those committees are designed simply to resolve disputes and are,
therefore, somehow meant to be the final port of call for an application;
or whether they are actually going to re-rehearse all the evidence
and have a completely different scientific judgment, (and a completely
different scientific discussion possibly). In that sense, it seems
unclear to me how accountable that system is. It is actually reasonably
transparent, to some extent, because you can find out what the
committee's deliberations were on the web site after the meetingin
some cases, I gather, even before the members themselves have
seen it or have cleared the minutes, which again is slightly worrying.
However, in terms of its accountabilitythe access to those
committees, who is on them, how are they formed, what kind of
job are they doingI have anxieties as to whether this is
operating in the public interest of the citizens of Europe.
205. The composition is not transparent?
Is that one of your criticisms?
A. The members
of the committees are appointed, it seems, simply by their volunteering
to sit on the committee. But it is very difficult for outside
parties to influence an essentially Brussels-based committee.
It is certainly less easy to influence or to understand its operation
and to put views into it than it is if you have a committee sitting
in your own country, where you can begin to build up at least
some kind of familiarity with how the committee is working.
206. But how otherwise should the Commission
deal with failure to reach agreement in council?
A. I think there
should be every effort to resolve it between the Member States.
If the problems are predominantly political, which is what they
are; they are disputes about the acceptability of certain risks
and not the scale of certain risks. That has been the nature of
the disputes. Therefore, recourse to another body of scientists
is not in our case going to solve that kind of problem. It simply
adds up to a yes/no judgment which, anyone who has objected to
beforehand, is unlikely to have confidence in.
207. But at least if it results in a decision,
if you did not have them there would be even fewer decisions.
A. I am sorry?
208. If it results in a decision which you
might otherwise not get.
the present system has not succeeded in resolving disputes, largely
because the interpretation of the Directive, as we were discussing
earlier, has been different in different Member States. The reason
for the disputes is that some Member States object to applications
because they feel the right things have not been taken into account.
Those problems are only resolvable by expanding the scope, or
at least thrashing out an agreement as to what the scope of the
Directive should be. They are, if you like, a protest about the
nature of the decision-making process, as much as they are about
objections to an individual application. It seems to me that recourse
to another set of scientific committees, without clearly the job
to resolve that kind of problem, is not going to improve the situation.
209. Is there any body at the European Union
level, operating with similar aspirations and organisation functions
to your own, which could represent the opinions you hold when
matters of dispute appear simply to be about to be resolved on
a yes or no basis in Brussels?
A. There is,
and I am sure they do. There is the international organisation
of Friends of the Earth which is called CEAT, which is a French
acronym, which operates in Brussels for international NGOs. They
do, of course, monitor the way that the scientific committees
210. Would you say that it is fully active
in this area?
A. It is hard
to say what "fully" means. As I was saying, I feel that
the problem is not just the inability to access those committees
if they were doing the right kind of job. It is that they are
not doing the right kind of job.
Lord Wade of Chorlton
211. I am still rather confused by this.
Basically what you are saying, as I understand it, is that the
views on these issues are very diverse. A lot of them are based
on emotion rather than upon scientific fact. It is where people
come from and how they see these issues, which is dramatically
differently. We are aware of that. You are saying that because
of this, the present system is not satisfactory. Whatever system
you have, how do you actually deal with that issue, when the scientists
can say, "These are the actual facts of the case and we see
it from a scientific point of view"; but other groups in
society can see it from an entirely different point of view. I
do not quite see how you say that is a problem with the present
system of decision making. How do you resolve any other system
of decision making that takes those two extremes, (or may well
turn to extremes)? The point I was talking to you about earlier,
that clearly there is a view on the economic issue. Many groups
in society put the economic needs before certain environmental
needs. You said to me, in answer to that question, that this is
a political decision and has to be taken from a political point
of view. Are you saying then that we set up political committees,
which ultimately make the decisions, yes or no, because decisions
have to be taken?
A. Let me be
clear about what I was saying about the possible inadequacy of
the scientific committees in the situation of dispute between
Member States on applications. The two things going on there are
the nature of the scientific advice on the possible effects of
each application, and whether that is accessible and accountable,
and the fact that some Member States want different kinds of environmental
impact taken into account. So it is not even about those broader
issues you were talking about, about where the social or economic
benefits are judged. It is simply a dispute about what is the
interpretation of environmental harm in this context. Some Member
States, notably Denmark, Austriaand Norway when there was
a time when they were likely to join the European Communitywhen
the first application for commercial consent went through, the
PGS oil seed rape, there were very strong representations by those
countries that part of the evaluation should be the effects of
the herbicide used in conjunction with the crop. That was the
root cause of the very long dispute within the Community about
whether that particular crop should be allowed through. That seems
to me the kind of dispute you can only resolve by talking to countries
about it: is there a resolution in terms of taking those effects
into account, or will they agree to drop that consideration for
this particular application but have it brought in for future
ones? Do you see what I mean? That particular point of contention
is not something you can solve by going to another scientific
committee and saying, "Is this a good thing or not?"
212. I accept that. What I am asking is,
what decision-making process do you establish if you accept that
there are different views, different priorities, in coming to
the right decision? Ultimately, decisions have to be made. What
I am asking you is what kind of process do you believe could make
decisions and be seen to be effective and people would respect
A. The process
should come out of the revision of the present Directivewhich
I think should seek to expand the scope of the Directive so that
it clearly takes into account all the possible environmental effects
of growing GM cropsI am not proposing that the regulatory
system embraces issues of need and benefit at this stage. I personally
think it is very difficult to do that. All I am asking is that
it embraces all relevant environmental considerations. At the
moment, there is serious dispute amongst European countries as
to whether that is the case.
Lord Willoughby de Broke
213. Are you concerned at all, that the
length of time of regulation of these matters which we have been
talking about, is putting European companies to a disadvantage
in relation to American companiesit is perhaps not your
concern but you are aware of thatwhere the regulatory process
seems to be much shorter?
A. The first
comment I would make is that the regulatory process in America,
in its principles, is surprisingly similar to Europe. Although
people try to make them look as if they are very different, in
practice I think in the way they seek to operate is very similar.
The delays in Europe, as I was saying just now, have been due
to the fact that Member States have not been able to agree upon
how we should judge the adverse effects of some of these products.
Therefore, the delays have not been endemic to the structure of
the regulation. They have been a consequence of its aspiration,
or rather the failure to spell out clearly what the aspiration
is of the Directive; what the role is of the Directive; and how
it should seek to protect the environment. It is not a failure
of the fact that it has to go to each Member State, be cleared,
and then sent back to the Commission or whatever. It is that in
that process, people have found more and more issues which they
feel they cannot deal with adequately, or that there is not agreement;
or that when each Member State gets an application, they find
they look at it in a very different frame. That is where the delays
and disputes have arisen. So, in that sense, the resolution has
to be a political one through a process of revising the Directive
to a more satisfactory state, where it more clearly and adequately
deals with all these environmental issues. If that can be achieved,
then things will be seen to be proceeding more smoothly. It may
mean that some things do not get clearance. That has to be accepted.
I hope we have the capability to say no to some of these developments.
In that sense, I am sure our European industry will argue that
it is a disadvantage, but I am afraid our primary interest is
that there should not be environmental damage and that if we have
to say no, we have to say no.
214. I confess I am a bit confused because
you made various answers in which you were very critical of the
centralised system of decision-making, yet I heard you say earlier
with regard to segregation that you did not think the United Kingdom
could do it alone, which implied to me that you felt that there
should be a centralised arrangement. That brings me to the question:
do you believe that the jurisdictions are about right as they
are, or do you think there is a case for giving individual Member
States greater latitude to go their own way, when it comes to
the question of granting commercial consents?
A. The issue
of segregation is a difficult one. If we are talking about segregation
of what are globally traded commodity crops, it implies requiring
American farmers or Canadian farmers or Brazilian farmers to segregate
their crops before they are bulked up and shipped to this country.
That is what I meant, I am not sure that our Government can require
that. I do not see what the legal basis could be for doing that,
other than banning the import of anything mixed. I cannot imagine
that being acceptable under trade rules as they stand. There is
a strong argument for looking at trade rules and the extent to
which they could be developed to allow countries to say no to
particular genetically modified foodstuffs or crops if they were
felt to have a human or environmental threat. That actually should
be possible under trade rules, at the moment, but you have to
show a very clear and immediate threat as opposed to a less clear
and possible long-term threat, so there is probably room for looking
at trade rules. This is what I meant about the difficulty of unilateral
action on globally traded commodities. In terms of jurisdiction
over environmental impacts, there ought to be a lot more room
for the United Kingdom Government to act. So that the United Kingdom
Government can, for instance, put conditions on the way that crops
are grown or the way they are managed in this country, to protect
the environment. I think we have certainly got to look at doing
that if we feel there is not satisfactory resolution in Europe.
Ideally, there should be resolution of these environmental issues
across Europe. This is because part of the reason why we have
European environmental law is because the environment does not
stop at political boundaries. We perhaps tend to forget that in
our geographical position, but for Continental Europe it seems
a nonsense to have different environmental standards for countries
who share basically the same landscape. For that reason, I think
having a European Directive for environmental protection in this
field is highly desirable. It is highly desirable that we get
it to operate properly.
215. As you will know, English Nature have
called, with the support of the other statutory agencies, for
a five-year moratorium on the growing of genetically modified
crops, to allow time for the subject to be better researched and
the regulatory system overhauled; possibly by increasing the remit
and membership of the Advisory Committee on Releases into the
Environment, in order to take a more comprehensive view on environmental
effects. Do you support that call and do you think it is necessary
to have this pause?
A. I think I
am right in saying that they have only called for a moratorium
on one crop, which is the PGS oil seed rape, but I cannot be absolutely
confident about that. I think it would be a very good thing to
have a pause. I personally voted against the commercial approval
for the PGS oil seed rape in the ACRE Committee and that is a
matter of public record. This is because I felt we could not be
clear enough about the long-term potential of the crop to hybridise
with wild relatives and what the long-term fate of the genes would
Lord Willoughby de Broke
216. Could you explain the problems which
you have with current risk assessment and what differences there
are between Member States. Is it wise that these risk assessments
are conducted by the applicant and not by the competent authority?
A. The problems
with risk assessment: the essential problem is the inability at
present to look at indirect effects, which we have already discussed,
so that the risk assessments tend to concentrate on the ecological
impact of the possible movement of genes from a crop to volunteer
populations of the crop, or to wild relatives. There is attraction
to things like the possible impact of engineering insect resistant
directly into a crop and how that may affect the surrounding environment.
However, the wider knock-on effects, particularly the effects
of chemical usage in conjunction with herbicide-tolerant crops,
are at present left outside the risk assessments and that is a
major failure. Another problem is the limitations of the case-by-case
practice of risk assessment. I mentioned just now that risk assessment
would look at something like an insecticide engineered directly
into a plant, where the plant is expressing the toxin. A risk
assessment would try to look at which insects that might affect;
for instance, would there be non-target as well as target species
affected? One of the problems of a case-by-case approach is trying
to get a view of those effects on a cumulative and additive scale.
You can maybe do it on one crop, in one particular management
context, but it is very difficult to ask the question: what happens
when a large range of crops, in a large range of situations, have
that kind of engineered toxin? What might be the overall impacts
on the insect populations? It is a question of the cumulative
impacts of using that crop as part of agricultural strategy. It
may well be that this is not something you can deal with in individual
risk assessments, but individual risk assessments should certainly
give us the clue to look at it on a much broader basis. So it
is the ability to look forward and be strategic that we lack,
I think. You can do an individual risk assessment in the light
of what has gone before, but it is very hard to do it in the light
of what will come ahead. Another problem for the risk assessment
system, as we have it, is that we do not have a clear interpretation
of what is harm to the environment. The Act deliberately avoids
it, to avoid pinning something down to which one could then see
exceptions. It is deliberately broad. The problem with that is
that it has tended to be narrowly construed and we do not have
a clear view of what is an acceptable impact on the environment.
The example we had just now of the PGS oil seed rape, the risk
assessment on that, when it was given approval for commercial
use it was assumed that there would be some hybridisation with
wild relatives, but the judgment was made that it would be on
a scale which was not a problem. I do not think that is the kind
of judgment which commands widespread acceptance at the moment.
A lot of people find that prospect alarming, or would say it is
unmeasurable and contains too large a degree of uncertainty, really
to base a definitive judgment of risk on the kind of data we have.
So that is another problem. We have contention about what is an
appropriate interpretation of environmental damage from this kind
of technology. Your question about what is the difference between
Member States: as I mentioned earlier, one of the primary differences
has tended to be the extent to which indirect effects are taken
into account. There is a quite helpful document that was produced
for the Science and Technology Options Assessments Panel of the
European Parliament, which is called An Appraisal of the Working
and Practice of Directive 90/220/EEC, on deliberate release
of GMOs, by Rene von Shomberg. That sets out, in some very helpful
tables, the different views and disputes between some of the Member
States about the operation of the Directive. Your point about:
is it a problem if the risk assessment is undertaken by the applicant?
I do not think it is a problem if the competent authority which
judges that risk assessment is in a position to challenge the
data submitted and the conclusions drawn from it. My impression
of the way the process works in this country is that the officials
who prepare the applications for the ACRE Committee consideration,
go through them in extremely thorough detail and check that all
the relevant questions have been addressed and that the right
information is there. Also, they check that the conclusions are
supported by the data and that nothing has been claimed as commercial
in confidence if the applicant cannot justify that. A great deal
of work is done to make sure that the applications are thorough.
All that correspondence goes on the Public Register so it is possible
to see what kind of backwards and forwards process has been undertaken.
What is more important is that we are asking the right questions
and making the right judgments. As I said earlier, one of the
problems is that there are large degrees of uncertainties built
in, in any judgments, about the environmental impact of genetic
technology. It is very important, in looking at risk assessments,
that we are clear where those areas of uncertainty lie and what
we are judging to be an acceptable level of uncertainty. That
is what a lot of outside commentators have a problem with. There
seems to be an end result that makes it look as if lack of evidence
of risk is actually evidence of safety. Those are not the same
things. We have to be explicit about uncertainty. This is one
of my major concerns about our system of having an applicant do
a risk assessment and then having that judged by the committee.
Perhaps both parties know what the uncertainties are but they
are not drawn out very explicitly.
217. Do you want the companies to take the
decision themselves on assessing these risks within the committees?
Do you think the committees could actually test these risks and
have a legitimate extension of the regulatory framework? Could
they actually test these risks if you are then assessing them
as being beyond the scope?
A. I am sorry,
would you mind repeating the question. I did not quite catch it.
A. You talked
a lot about risk assessment and undertaking risk assessment before
things go ahead. The question is whether the company wanting to
undertake any genetic experiment can actually test the risk you
are assessing. You say this is an unacceptable risk. Can the company
then go out and test that risk?
A. So can there
be adequate data on whether something is dangerous or not? Is
that what you are saying?
218. You are making a risk assessment to
say that we think this is an unwise experiment or test because
of X,Y or Z. I am asking you, could the company challenge your
risk assessment and do the test, as to whether there will, for
example, be cross-pollenisation into the wild environment?
A. The problem
is that a lot of the issues, which are being put forward as possible
risks and being judged, are ones which it is almost impossible
to empirically test. To give you an example of hybridisation with
wild relatives of an oil seed rape crop. Most risk assessment
tends to be based on whether it has been possible to almost forcibly
cross oil seed rape with possibly compatible species in laboratory
conditions. To begin with, it was said that this had hardly ever
been observed in the field. As time has gone on, various researchers
have observed particular hybridisations in the field, and some
have been quite surprised by the fact that they have been able
to observe them and observe them at a greater rate than was thought
possible. That is the sort of thing which is only possible when
the experiments or the commercial growing is done on a very fairly
large scale. This is the point about what scale of release do
you sanction, in order to get that kind of data before it presents
itself as an unacceptable risk? This is my point about looking
at the issues after commercialisation. With some crops it would
be impossible to come to any very definitive answers about how
far things like cross- hybridisation are going to occur. It may
well be quite proper to judge that it is unlikely that they will
occur at a scale that causes us real problem. Certainly, it will
not happen quickly but we should be monitoring to make sure that
is the case. In a way, you have an on-going risk assessment on
that kind of issue. There are other issues to which you might
quite properly say we do not have enough information and, therefore,
nothing should go ahead. Under that category you possibly have
things like work with virus resistance, where we have very little
information about the possibility of recombination of viruses,
for instance. That may be the kind of work which is too risky
to take to a commercial scale. It is very hard to quantify the
extent to which it might be possible to create a new plant virus.
I really think it differs with the crop which is under consideration
and the scale at which it is being used at the time.
219. You call, in your paper, for clarification
on the subject of liability of damage caused by GM crops. Does
your Alliance have views on that subject as to what the liability
A. Yes. Personally,
I think there should be strict and retrospective liability for
damage from GMOs. We have advocated that for other forms of environmental
damage. It is even more important in this field.
220. How far should the risk assessment
come after the experiment, which was the point I was trying to
bring out in my question. Obviously there is the fact that you
do not really learn a lot unless you are prepared to take risks.
If you say "de-risk", companies are not really going
to make great strides forward in learning. This brings me on to
the question of responsibility of companies. What, in your view,
are the responsibilities of companies developing genetically modified
crops, and should they have a wider responsibility other than
just trying to find out scientifically the effects of the experiment?
A. Yes, I think
they should. I would say they have responsibility to consult stakeholders.
For this technology there is a very wide range and very large
number of stakeholders. Companies developing these crops are effectively
asking the entire consuming population to eat the food that results
from them. They are also asking all of us, possibly, to bear a
certain degree of environmental risk. In that sense, the earlier
they address those kinds of concerns and talk to interested parties
about the concerns and the priorities people have, the more chance
they have of developing products which do have clear benefits
and do not present risks.
221. There is a growing body of concern
about the risks that GM food is putting forward, but most GM food
is grown in the United States at the moment. Why has there been
such a different reaction between European consumers and American
A. I do not know
in detail. I do not think anyone can know really. I can make two
conjectures. One is that the United States has not suffered the
same crises of confidence about the handling of food risk that
we have in Europe. Everyone hates the analogy with BSE but let
me make it clear what the analogy is. The analogy is not one of
a similar type of risk necessarily. It is an analogy about the
political handling of risks that are hard to quantify. The fact
that the politicians were willing to say "it is safe"
when they had no basis for doing so. The fact that they were prepared
to attribute responsibility for the problems to their scientific
advisers, which I think is entirely unfair. In that sense there
is an analogy with GMOs. Consumers are wondering, "Well,
they told us it was safe last time, does this apply here? How
can we be confident that the right relationship is established
between the scientific advice and political judgments on that
scientific advice?" So maybe the United States has not suffered
quite that kind of crisis of confidence on that level. The other
conjecture is that the United States has rather more natural environment
left than we do. Most of the United Kingdom environment is either
semi-agricultural or, in fact, fully agricultural. A lot of our
remaining precious landscapes and small pockets of biodiversity
are embedded in that agricultural and semi-agricultural landscape.
In that sense it is possible that GMO crops could have a disproportionate
effect on what is left of our biological diversity. That is not
true in the United States because they very sensibly fenced off
large areas of wilderness so that they are untouchable. They are,
however, engineering native species to be genetically modified
and I think that is a huge risk. I do not know why American consumers
are not more concerned about that.
222. On that provocative note I think we
will have to end. Thank you very much indeed for coming to give
us your evidence.
A. You are welcome.
Thank you, my Lord Chairman.