AGRICULTURE
AND ENVIRONMENT BIOTECHNOLOGY COMMISSION
LIABILITY SUB-GROUP
MEETINGS ON FRIDAY 18 JANUARY
2002 IN BRUSSELS
Note:
These are the views of the group, and not necessarily of the full Commission
Present:
Phil Dale
Matthew
Freeman
John Gilliland
Malcolm Grant
Derek Langslow
Justine
Thornton (Convenor)
Anne Packer
(Secretariat)
1. Sue Mayer and
Roger Turner were unable to attend and sent apologies.
2. Justine
Thornton thanked EuropaBio for arranging the meeting, whose purpose was to have
informal discussions. She explained the
background to the AEBC and to the liability group’s work, including its current
meetings in Brussels.
3. EuropaBio is
an industry association representing different sectors which are using modern
biotechnology, including food, pharmaceuticals and ag-biotech input companies
such as seed companies. Simon Barber’s
plant biotechnology unit works with innovators in the seed industry. Associations from Member States tend to
represent substantial numbers of small and medium enterprises. EuropaBio’s role is to provide advice to
policy makers in the Commission and Parliament and also to Member States, to
promote biotechnology as a useful technology.
Often quite basic scientific explanations were needed, because many
people are not aware of the scientific background eg with adventitious
presence, to explain that a zero threshold is not feasible.
4. EuropaBio have
noticed a tendency for European summits to be positive about biotechnology
while alongside that, the regulatory frameworks tend to put up major hurdles,
and to remove the scope for choice.
In the draft European Commission proposals on environmental liability,
GMO products are classified alongside nuclear waste. If this remained, it would be hard to encourage firms to develop
the technologies - it sometimes seems as if law making is undertaken without a
full understanding of the relevant biology.
It is hard to draft relevant definitions, such as defining the
‘environment’, ‘environmental harm’ and ‘environmental damage’.
5. In discussing
how easy it would be to identify causation for potential changes in
biodiversity or potential damage from GMOs, EuropaBio said in some cases it
would be possible to work out the origin of a plant with little difficulty eg
from analysis of its DNA, so liability would be fairly easy to establish, but
diffuse effects on biodiversity would be hard to trace to their origins.
6. Simon Barber
considered that there should be similar provisions for similar products. Members discussed possible advantages of a
system which treated all ‘novel’ products in the same way - as equally
dangerous/equally safe, rather than by treating them differently if they were
made by different processes. This might
be a logical approach, and was used for example in Canada. (There would be issues of how to define when
a product stopped being novel.) It was
noted that in conventional marker-assisted breeding, it would be possible to
select very precisely and to make major changes in products. There were issues about how these
substantially but conventionally changed plants should be treated in comparison
with genetically modified plants.
Industry members might have concerns if the effect was to increase the
scope of a restrictive regime. They
would want products that have gone through stringent requirements to be subject
to the same liability regime as products that are comparable from a risk point of
view. This criterion is an obvious one,
especially once a product has gone through a risk assessment and regulatory
review. There would appear to be no
scientific or legal basis to subject these products to additional liability
provisions.
7. Industry would
want proportionate measures, rational and reasonable, across the board, in a
precautionary way. In response to a
question, Simon Barber said he did not think industry would accept a liability
regime as a ‘pump priming’ exercise for GMOs, as a way of encouraging public
acceptability for GMO products. In fact
the opposite would be likely to be the case – where there is
technology-specific additional liability based on mere perception of risk, this
perception will be likely to be strengthened by the fact that the legislator
considers it to be a sufficient reason to put in place a specific liability
regime. Also this was because a regime
would need to be justified in itself - once a regime were imposed, it would be
likely to stay in place. He also said
that GMOs would have to comply with a major safety regime in any case; they
were in a very different risk category than nuclear waste for example. There were GMO parallels with product
liability, and if something had gone through a regulatory system, and been
approved with strict standards, liability would exist if the high standards
were not met.
Baselines
and goals
8. Simon Barber
said it was important to be pro-active and forward looking: to set goals for
what aspirations should be eg on biodiversity (whether birds or
micro-organisms), and to have baselines.
EuropaBio consider it important to establish a baseline for making
decisions. It was important to remember
the scope for major environmental improvements from GM, eg with cotton in
China.
9. In discussion
on basic principles of how to allocate responsibility, Simon Barber agreed that
all who benefited from developments should also be partially responsible –
including for example consumers. In
response to a question, he did not think that members had considered whether it
might be useful to set up a joint compensation fund, but would enquire. Action: Simon Barber. He considered that an insurance-based system
would de facto impose consolidation (with fewer and larger companies) on the
industry, as the potential costs were very high.
10. In discussing
how scientific aspects were factored into policy-making discussions, Simon
Barber said that people in industry sometimes saw the EC decision-making
process as lacking transparency - being
largely behind closed doors and not taking scientific aspects effectively into
account. AEBC members noted that
consultation was important in reaching decisions, and that it was important to
keep doors open.
11. Simon Barber
noted that some companies were moving from Europe to North America, and some
were closing research institutions in Europe because of the climate of opinion
in Europe.
12. Members
discussed the extent to which consistency across Europe on economic liability
was important, since this would not be covered by the draft Directive. In general, Simon Barber said that industry
valued both consistency of provisions and consistency of implementation. He was not aware of members’ views on a
country-by-country approach to economic liability.
13. Discussing
tolerance levels and adventitious presence of GM material, Simon Barber
referred to a May 2001 paper on the need for clear rules for the seed trade,
which he would give to AEBC members.
These were major issues for the seed industry, and were threatening the
existence of non-GM producers. Policy
seemed to be developing differently in different countries.
14. Simon Barber
thought it would be difficult for small institutions, including universities,
to continue work if insurance was required.
It was costly and problematic, as insurers have little or no experience
on which to assess potential risks. In
answer to a question, he considered that farmers would need to have some element
of liability for their own acts, but responsibility could not remain wholly
with the original manufacturer.
15. Justine
Thornton asked whether a compensation fund within a fault-based liability
regime and based on the concept of ‘novel’ crops might be a way forward. Simon Barber did not know what his members’
views on this approach would be. In
response to a question about whether a liability regime could make the public
more confident about genetic modification, Simon Barber said that many members
of the public were probably not aware that there were existing regulatory and
liability regimes, so they might not be very aware of a new liability regime
either – hence this might not have much impact on public views. NGOs clearly had views, but it was hard to
get a clear picture of the views of the wider public.
16. EuropaBio said
that while liability is important, it is one among a range of important issues,
including work on food and feed, traceability and labelling and the biosafety
protocol. The main emphasis should be
focussing on the future, setting goals for how we want the environment to be,
with a vision of where we want to be in twenty years’ time, rather than on a
focus on what is currently not good. A
proactive approach is needed. AEBC
members referred to a number of initiatives in the UK which were trying to take
on this agenda, including the food and farming policy commission.
17. AEBC members
thanked Simon Barber and Raffaella Colombo for the interesting discussions.
DISCUSSIONS
WITH EUROPEAN COMMISSION DG ENVIRONMENT: MICHAEL HAMMELL AND CHARLES
PIROTTE
18. These
discussions were held over lunch.
Malcolm Grant and Justine Thornton thanked Michael Hammell and Charles
Pirotte for joining the AEBC liability group for informal discussions. Mr Hamell works in the Environment DG as a
link with the agriculture DG. M Pirotte
has responsibilities for developing the environmental liability
instruments. Damian Phillips (NFU) was
also present.
19. Charles Pirotte said that, all being well,
the Commission might adopt a proposal for a draft Directive on environmental
liability the following week. As to
time scale after that, it was hard to predict, since the first stage involved
the Presidency taking forward the measure, which would depend on each
presidency’s priorities and time needed by the European Parliament to deliver
its opinion in first reading. The
second stage was a formal stage, over a fairly short number of months. There might be a third – conciliation - if
the legislation were contentious. There
was then a further two years for transposition into Member States’ national
laws.
20. Charles
Pirotte said that there had so far already been many consultations on liability
– perhaps more than on other files at a similar stage of development. There had for example been a Green Paper in
1993, which elicited many comments, a Joint hearing of Parliament and
Commission in 1994, the February 2000 White Paper, and the 2001 Working
Document, a range of meetings with national and local experts as well as
stakeholders (industry and environmental NGOs). All of these had involved consultation, and views of consultees
inevitably diverged, which was where policy-making became important.
21. AEBC members
asked about the extent to which opinion had moved since the publication of the
White Paper. Charles Pirotte said that
there had been considerable discussion over civil liability. As a result of discussions both about
contents and about competence and subsidiarity, the European Commission had
concluded that traditional damage (eg personal injury and damage to property)
should be outside a European Directive.
Traditional damage was an issue where Regulations would be for Member
States in the first instance. There
were discussions about whether liability should be strict or fault-based. There were a number of initiatives at
international level, with protocols covering some aspects of traditional
damage. For example the Basle protocol
made provisions about movement of waste.
In prospect, there could be a civil liability Protocol for damage caused
by Living Modified Organisms; the EC is a party to the Biodiversity Convention
and is about to become a party to the Cartagena Biosafety Protocol, which
covers trans-boundary accidents. In
future, issues would arise including questions of EC jurisdiction eg whether
the Commission will be given a mandate to negotiate in the living organisms
civil liability Protocol.
22. The
environmental liability proposal included a clause for Member States to report
after five years. There was thus the
possibility of traditional damage being included in future, and it might also
be affected by international protocols.
23. Asked about
the extent to which farmland was included in Natura 2000 sites, Charles Pirotte
said that until studies on the network were completed nobody knew this, or the
extent of forestry areas. Work had so
far been completed on the smallest of the five geographical areas and was
underway in the others. The July 2000
working document contained proposals to include also sites designated by
national laws and some species – those strictly protected and under real
threat. AEBC members considered that
the substantial majority of farmland would largely be outside the designated
sites, and that this will be relevant when it gives advice to the UK
Government.
24. The 1992
Convention on biodiversity, which was legally binding, includes a scientific
definition of biodiversity (covering in the broadest possible way variability
among living organisms, so that it could even encompass for example
micro-organisms in the soil). NGOs
would like all aspects of biodiversity within that definition to be included in
any EC Directive. As the Convention was
a framework document, the definition may not have been drafted by UNEP for
read-across eg for liability purposes, and the Commission have not used this
approach; it remains to be seen whether it might be relevant for a civil
liability protocol on living modified organisms.
25. AEBC Members noted
that there had not been provision for a ‘state of the art’ defence in earlier
papers, while there were such provisions in the product liability Directive, if
there was subsequent, unforeseeable damage, and they would be interested to see
whether this was included in the draft Directive.
26. The group
discussed the role of science and policy making in framing the provisions, and
whether it was appropriate to put GMOs alongside nuclear waste as being
inherently dangerous, while other developments in plant science which were done
without genetic modification were not included at all. Decision-making had to take account of
public perceptions, though this was clearly not the only factor. At Community level, the main criterion for selection
of activities to be covered was those for which there was already a current
legal framework – in the case of GMOs this included the Directive on GMOs.
27. AEBC members
said that while they realised the lists for coverage in a liability regime
would reflect subjects on which there is already European legislation, the
effect may be to have different liability regimes for two identical products
created in different ways but each with the same possibility of hypothetical
problems. They asked how items for
inclusion in the list were chosen.
Charles Pirotte said it was a policy making choice and some Member
States, eg Germany and Sweden have listed specific items.
28. Annex I to the
draft Directive included a list of areas to be considered as inherently or
potentially risky, and GMOs had been included in that category. Charles Pirotte thought that the likelihood
of amendment to Annex I, when the Annex is discussed by Council and the
European Parliament during the legislative process, was high.
29. The Commission
recognised that provisions had to be realistic. There had been a relatively recent Opinion of the Advocate
General in a European Court case, followed by the judgement of the Court, which
was relevant and interesting. On the
question of whether it was possible to label some food as ‘purely natural’
while a minimum level of pesticide and heavy metal residues was present in the
food, the Advocate General and the Court considered that it had to be
reasonably expected that a residual presence would occur given the current
state of environmental affairs. The
Advocate-General reserved his position with respect to biological products,
since those are subject to specific and quite stringent requirements. Charles Pirotte would be able to let AEBC
have a copy of this. Action: Charles Pirotte
30. AEBC members
asked whether there would be any provisions about industries working within
regulatory permits, and Charles Pirotte said that they would need to see the
Commission’s proposal as to whether this would be included. The Habitats Directive made provisions for
compensating damage to habitats in certain cases, so for habitats covered by
those provisions (Article 6(3) and (4)), there would not be a need for the
horizontal liability proposal to come into play. (The draft liability Directive is also based on
restoration.) Discussing how to
establish a baseline for habitats, it was noted that such information should
become available for Natura 2000 sites, and that hopefully Member States would
have similar information for their national sites. The starting points should be known, and there were tools
available in assessing biodiversity, land and water quality and damage to
them.
31. AEBC members
asked whether internal market considerations applied to provisions for the
relationship of European with national laws.
Charles Pirotte said that this was not the case at present but in due
course the European Commission might want to consider if there should be
legislation should any evidence of significant distortions of competition
emerge. This kind of issue would arise
when reviewing the scheme in the light of the sustainable development impact
assessment, the setting up of which is foreseen in the Commission Communication
to the December European summit on the regulatory environment.
32. AEBC members
asked whether the EC had considered the possibility or desirability of having a
compensation fund. Charles Pirotte said
that it did not seem appropriate for the environmental liability Directive to
cover diffuse pollution at all since liability is ill-suited for damage caused
by diffuse sources. The European
Commission considered diffuse pollution important, but to be covered in other
ways, for example by pollution taxes in member States.
33. Charles
Pirotte said the focus of the Directive would probably be mainly on major
damage, though this would depend on the definitions used in the Directive, and
on their interpretation. It would not
cover diffuse pollution, which was an important area, but covered by other
mechanisms, eg pollution taxes. Members
noted that AEBC would need to consider diffuse impacts separately in its work
on liability.
34. AEBC members
thanked Charles Pirotte and Michael Hammell for the interesting discussions.
35. Justine
Thornton thanked Gill Lacroix for arranging the meeting, whose purpose was to
have informal discussions. She
explained the background to the Agriculture and Environment Biotechnology
Commission and to the liability group’s work, including its current meetings in
Brussels to discuss European work on an environmental liability regime. AEBC and NGO members introduced themselves
and their particular responsibilities.
36. NGOs were concerned that substantial changes were being made to proposals
for a draft Directive, that basic requirements were not being met and these
would mean big gaps in the regime. It
looked likely that there would now be a legal defence if companies had complied
with permits within the regulations.
This takes out the polluter pays principle and judgements will be
political not technical. There has been
a gradual and unnecessary dilution of proposals.
37. The definition of biodiversity was an issue. The draft Directive should use the convention on biodiversity
definition, to which the European Union is a signatory, whereas it was being
limited to animals, species and areas set out in the Habitats and Birds
Directives, and those protected under national legislation.
38. There were also concerns about the burden of proof, and problems of
access to justice. Less than 10% of
land would be protected by the provisions, which was not adequate. The tax payer would carry the burden for
economic damage to property, since this was not within the proposal and was
being left to Member States. Whether
liability is for farmers or seed companies will be important.
39. When the GMO deliberate release Directive was being revised, the
parliamentary committee amendment on liability unfortunately fell in unusual
circumstances. The European Commission
did not support liability being included in that Directive and indicated that
liability for GMOs would be covered by a future environmental liability
Directive instead. The terms of the
draft meant that the European Commission was failing to provide adequate
liability provisions for GMOs.
40. In answer to a question from AEBC members, NGOs were not aware of anyone
having done a study of liability and biotechnology in different Member
States. There was discussion about the
choices for all types of farmers, the precautionary principle, and about
co-existence between farming methods.
41. There was discussion about biodiversity concerns relating to herbicide
tolerance generally, as tolerance can be achieved by conventional breeding as
well as by genetic modification. NGOs
have concerns about these crops also; they noted that the draft Directive does
not include liability provisions for conventional crops.
42. There was discussion about establishing a threshold for adventitious
contamination of conventional seeds with GM seeds. NGOs consider that the threshold should be 0.1%, as this is the
level of detectability.
43. There was discussion about horizontal legislation. NGOs have seen no positive examples of
horizontal mechanisms – ie ones across a range of industries and processes –
working. They consider specific
measures more appropriate and would prefer liability provisions to be linked
specifically to the GMO Directive.
Industry should be prepared to pay any costs, and should have their own
compensation fund. Insurers seemed wary
of GMO insurance. Consumers should not
have to contribute to a compensation fund.
The extent to which farmers are liable should depend on whether the
product was faulty and whether they used the product properly. Consumers perceive biotechnology as risky
and not having clear benefits – a clear liability regime is needed to encourage
more confidence.
44. Friends of the Earth and Association of European Consumers provided
copies of some relevant papers, which the AEBC secretariat would copy to all
members of the liability group of the Commission. Action:
AEBC Secretariat
45. AEBC members
thanked the NGO representatives for the interesting discussions.
46. Andrew
Dalgleish confirmed it looked likely that the EC environmental liability
proposal would be adopted the following week.
Until there was a proposal there could be no UK policy – that would then
be considered. European Commission
policy had been evolving over the past 10 years or more. The proposal may have considerable inbuilt
flexibility, but there would probably still be some key issues for further
discussion, and the European Parliament would want to consider the instrument’s
balance in detail. Some consumer groups
and NGOs thought more should be done to strengthen the instrument. It was not easy to predict the priority the
new Spanish Presidency would give to the measure. The following presidency was Danish; there had been policy
changes since the new Danish Government was elected.
47. The proposal
would probably be debated in the Environment Council on 4 March. The principles would be likely to find
widespread support but thinking about the actual impacts might vary around
Europe. For the European parliament, it
was not certain which Committee would be in the lead – for example the legal
affairs or environment committee. The interaction of the Directive with
domestic legal systems would be important eg how strict or fault based
liability interacted in domestic law and European law – most countries other
than Spain currently have an environmental liability regime. For example, if NGOs had rights under civil
law to bring action, this would be a fundamental change to UK law.
48. Malcolm Grant
noted that AEBC would like to see the proposal when it was adopted. Andrew Dalgleish and the AEBC Secretariat
agreed to stay in touch. AEBC members
thanked Andrew Dalgleish for the interesting discussion.
February 2002
