CHAPTER TWO: THE SCIENTIFIC ADVISORY SYSTEM
FOR GENETICALLY MODIFIED FOOD
The Advisory and Regulatory Systems concerning
GM Food and Crops
36. The Government's first priority in respect of
food regulation is to "protect public health in relation
to food by promoting and enforcing high standards of safety at
all stages of its production, processing and supply".
Research and cultivation of GM crops and their use in food is
"tightly" regulated and operates at both UK and EU levels.
Both EU and UK regulation is based on the precautionary principle.
In practice this means that strong evidence is required that a
genetically modified organism (GMO) presents a very low risk before
consent is given for its use.
37. The current regulatory regime relating to GM
crops and food had its origins in the 1970s when researchers were
the first to call for, and achieve, a voluntary moratorium. From
1978 any work involving genetic modification had to be notified
to the Genetic Manipulation Advisory Group and the Health and
Safety Executive (HSE). The Genetic Manipulation Advisory Group
was replaced in 1984 by the Advisory Committee on Genetic Modification
(ACGM) which is still the body responsible for advising the HSE
on the contained (i.e. laboratory) use of GMOs. Responsibility
for regulation and the provision of advice on other aspects of
genetic modification has since been passed to other authorities,
chiefly the Advisory Committee on Releases to the Environment
(ACRE) and the Advisory Committee on Novel Foods and Processes
(ACNFP) although there is a number of other expert bodies within
the scientific advisory system which the Government may call upon.
MAFF told us that "in all the Government has access to some
60 experts when seeking advice on the safety of GM Foods".
REGULATION OF RELEASES OF GMOS TO THE ENVIRONMENT
38. Releases to the environment are regulated in
the UK under the Genetically Modified Organisms (Deliberate Release)
Regulations 1992, which implemented EU Directive 90/220. The competent
authority in the UK is the Department of the Environment, Transport
and the Regions (DETR), advised by ACRE which was established
under the Environmental Protection Act 1990. That Act also introduced
a structured regime of notification and risk assessment which
was designed to prevent or minimise "any damage to the environment
which may arise from the escape or release" of GMOs.
Any release into the environment of a GMO, from growing a single
plant in a pot to large-scale commercial planting of a crop, must
be notified to, and in many cases authorised by, the Secretary
of State for the Environment, Transport and the Regions.
Applications for releases must be accompanied by comprehensive
information including an environmental risk assessment, details
of the nature of the organism, the origins and types of gene sequences
to be transferred and the transfer technique.
Applications to market GMOs follow a similar procedure but must
also be approved at EU level. For successful applicants these
procedures result in a European Union-wide permit to grow commercially
or market their product.
The EU and UK Regulatory System
HSE advised by ACGM
Experimental Release (growing plants outdoors, field trials and cultivation)
DETR advised by ACRE
Details of all releases circulated to all EU States
(I)consent to market GM food in the EU;
(II)consent to market GM seed;
MAFF/Department of Health advised by ACNFP and other committees
(I)Marketing consents sent to all EU States
(II)Directive 90/220 plus various seeds Directives
(III)Novel Food Regulation 1997
Source: Parliamentary Office of Science and Technology,
POST Note 115, May 1998.
REGULATION OF GM FOOD
39. Until 1997 the UK operated its own approval system
for all food derived from GM crops or containing GM ingredients.
In May 1997 the EU Novel Foods and Novel Food Ingredients Regulations,
which set community-wide standards for safety assessments of novel
foods, came into effect. The competent authority in the UK is
currently the Ministry of Agriculture, Fisheries and Food (MAFF)
although the Food Standards Agency will take on this responsibility
if the necessary legislation comes into force.
MAFF is advised by ACNFP. Under the EU Regulations companies wishing
to market new GM food products must apply to the Member State
in whose territory they first intend to market their product so
that a safety assessment can be carried out. Applicants are required
to provide detailed information about the genes and organisms
involved, the processes used for genetic modification, the nature
of the food product and any processing involved.
The Member State then has 90 days to reach a conclusion after
which a report is circulated to all other Member States. Member
States can raise objections within 60 days. If objections have
a scientific or technical basis and cannot be easily resolved,
the EU Scientific Committee for Food makes an assessment which
forms the basis for a final decision taken jointly by all Member
States on the basis of qualified majority voting.
Once a GM food has gained marketing consent in one Member State,
it may then be sold throughout the EU.
40. Both ACRE and ACNFP may seek guidance from other
scientific advisory committees as necessary. Typically these might
include the Committee on Toxicity of Chemicals in Food, Consumer
Products and the Environment, the Committee on Medical Aspects
of Food and Nutritional Policy, the Advisory Committee on the
Microbiological Safety of Food and the Advisory Committee on Pesticides.
In addition they may also draw on the expertise of the Food Advisory
Committee on such matters as that of labelling.
THE EU-UK RELATIONSHIP
41. Decisions regarding the commercial release of
GMOs are made at EU level through qualified majority voting. Once
a consent has been granted for a GM crop, no individual Member
State can ban its use, even if the assessment work on environmental
impact has been done elsewhere. English Nature believes that "given
the difference between wildlife habitats and distribution across
Europe, and differences in farming practices, ... it would be
better to allow subsidiarity in marketing approvals".
We believe that subsidiarity in this area would prove unnecessary
in the majority of cases and would increase the workload of advisory
committees significantly without any tangible benefit. The House
of Lords European Communities Committee suggested that "Member
States should have the right to opt-out of growing certain GM
crops for domestic or environmental reasons".
The Government has rejected this proposal, stating that it sees
"no reason for Member States to impose additional restrictions"
and that the current provisions of Directive 90/220 are, in this
regard, satisfactory to ensure the protection of the environment.
This is at odds with Mr Meacher's evidence to the House of Lords
Committee that the Government was seeking to ensure that the scope
of the Directive and environmental risk assessments were broad
enough to cover direct and indirect effects of GMOs.
Even if that were to be achieved, it would not necessarily address
concerns about differences in habitat and farming practices. Professor
Beringer told us "normally if you have European marketing
approval it applies everywhere ... If there is sufficient concern
that it needs to be limited, then it probably should not be grown".
We recommend that the Government seeks to ensure that EU regulations
permit local discretion in relation to specific farming practices
and habitats in any particular region.
INTERNATIONAL AND TRADE CONSIDERATIONS
42. The application of the precautionary principle
results in a regulatory system for GM crops and food that is distinctly
different from that used in the USA. US regulation covers a narrower
range of GMOs and is based on assessment of damage rather than
of safety. This may have significance if different safety standards
become a barrier to trade. There are provisions in existing trade
agreements for decisions based on the precautionary principle
but these have not been tested. Any disputes would be referred
to the World Trade Organisation and in turn to the Codex Alimentarius
Commission, a joint Food and Agriculture Organisation and World
Health Organisation body. Codex sets international food standards
and is the final arbiter where trade disputes depend on health
issues. Codex is untested in the area of GM food but has previously
shown itself ready to rule against the EU as it did on
the issue of hormones in beef. Codex operates through a series
of committees with extensive industrial involvement but little
participation on the part of consumers.
Codex is only permitted to consider 'valid' scientific reasons
before products can be prevented from entering the market in a
member country, which raises the questions of what is a valid
reason, and who should judge? We recommend that the Government
seeks to establish international agreement on what constitutes
a 'valid' scientific reason; and that the definition of validity
is based on the precautionary principle. We further recommend
that the Government should press for Codex to find a means of
reconciling the US, EU and UK approaches to GMO regulation.
The Quality and Integrity of Scientific Advice
THE EXPERTISE AND MEMBERSHIP OF ADVISORY COMMITTEE
43. The quality of scientific advice to Ministers
rests largely upon the expertise of the committee members. Some
witnesses argued that both ACRE and ACNFP had insufficient expertise
in key areas. For instance, Friends of the Earth claimed that
ACRE needed more expertise in soil science, pollen movement and
Dr Katherine Venables, a member of ACRE and a former member of
ACNFP, argued for a wider range of medical expertise, such as
toxicologists and public health specialists, to be included.
44. Other witnesses pointed to the eminence of the
scientists currently serving on advisory committees and the respect
that these committees command internationally. MAFF believes that
ACNFP members "are all eminent, practising scientists or
medical experts with international reputations".
DETR states that "ACRE's views are widely respected, both
domestically and internationally".
The Royal Society of Edinburgh told us "the thoroughness
and quality of scientific advice available on this issue is good".
The Minister for the Environment, the Rt Hon Michael Meacher MP,
was emphatic that the advice his department received from ACRE
was of "unquestionably high quality".
While expertise in all the main relevant scientific disciplines
should be represented on scientific advisory committees, we do
not consider that it would be practical, or indeed possible, to
constitute committees to include world-class scientific expertise
on every aspect of science that might ever come before ACRE or
45. The Green Alliance, among others, argued that
ACRE's recently extended remit (see paras 63-4), which now includes
examining the cumulative and indirect effects of GMOs in the environment
and changes in agricultural practice, will necessitate a change
in the expertise represented on the committee.
Professor Beringer agreed.
The Minister has acknowledged this and has already stated his
intention to take the opportunity presented by the retirement
of some members of ACRE to review the expertise needed.
We welcome this commitment.
46. Under the rules devised by the Committee on Standards
in Public Life, ten of ACRE's 13 members, including its chairman,
will come to the end of their term of office this year and will
not be eligible for reappointment. We are concerned that such
a large proportion of ACRE's membership should change at the same
time. We regret the break in continuity that such a change will
inevitably cause. We note that the Commissioner for Public Appointments
has recommended that when a number of simultaneous appointments
are made to one body, Departments should recognise the future
difficulties of losing a large number of members at any one time
and should stagger the duration of appointments.
We agree. We recommend that the Government avoids circumstances
where large changes in the membership of scientific advisory committees
are required at the same time.
REPRESENTATION ON ADVISORY COMMITTEES
47. Some witnesses from the food manufacturing and
retail industries argued that they should have greater representation
on scientific advisory committees concerned with food issues.
For instance, the Food and Drink Federation suggested that "much
expertise resides within the food industry itself. There is no
reason why this should not be exploited within the Advisory Committee
Somerfield Stores argued that "the food chain are involved
in the consequences" of judgements made by the scientific
advisory system and that it needed "therefore to have an
input into the decision making process" .
We are not persuaded by these arguments. We recognise that a good
deal of expertise in this area resides in industry, particularly
in the biotechnology sector. Ministers must, however, secure appropriate
expertise on advisory committees rather than attempt to give representation
to any particular groups. We recommend that the Government
rejects calls to include, as a matter of course, representatives
of any particular interest on scientific advisory committees concerned
with genetic modification technology.
48. Both Mr Meacher and Mr Rooker drew a distinction
between those scientists serving on advisory committees with research
connections to the biotechnology industry and those directly employed
by biotechnology companies. Mr Meacher suggested that, because
the presence of biotechnology industry employees on ACRE had in
the past brought into question the integrity of its scientific
advice, he proposed "to avoid having people directly employed
by industry" on the Committee in future.
Mr Rooker disagreed. Although none of the current membership of
ACNFP is directly employed in the food industry, he told us that
"it is not ruled out for the future".
A considerable amount of expertise on genetic modification resides
with the companies that are actively developing the technology.
We recommend that the Government rejects proposals to bar employees
of biotechnology or food companies from serving on scientific
advisory committees. It is vital that appointments to scientific
advisory committees should continue to be made by selecting people
with the most suitable and relevant expertise.
COMMITTEE MEMBERS' INTERESTS
49. Both ACRE and ACNFP have provisions to ensure
that members declare interests and have procedures for dealing
with any conflicts of interest which may arise. The procedures
for handling conflicts of interest in ACRE are set out in the
1998 ACRE Annual Report: "Members are required to inform
the Committee and the Committee decides whether the linkage requires
the member to be absent from the discussions. The decisions of
the Committee and its reasons for including or excluding the individual
ACNFP follows a similar practice.
50. These rules have not prevented accusations of
partiality. A number of witnesses pointed to apparent conflicts
of interest among ACRE and ACNFP members. Iceland plc, among others,
told us that the composition of ACRE was biassed towards the biotechnology
industry and added that considering "the composition of the
ACNFP and ACRE, it is not surprising that such a self interest
Friends of the Earth claimed that "8 out of 13 members [of
ACRE] have clear links with the biotechnology industry" and
that the chairwoman of ACNFP appeared to be "an additional
spokesperson" for the biotechnology industry.
Other witnesses, such as Novartis and the Food and Drink Federation,
discounted such accusations.
Mr Meacher told us "I have no reason to believe that the
existing two members [who work in the industry] have not acted
perfectly properly" and that "Contrary to views that
half of the membership are employed by the biotech industry, that
is absolutely not true".
Indeed, only 2 of ACRE's 13 members are directly employed in the
biotechnology industry. We condemn the unjust attacks that
have been made directly or indirectly against public-spirited
scientists who have served the community well on both ACRE and
ACNFP. We endorse Mr Meacher's view that the current members of
ACRE who are employed by the biotechnology industry have acted
properly and with integrity as have members of ACNFP.
51. We have consistently supported, indeed advocated,
Government efforts to encourage scientists in universities and
Government research laboratories to commercialise their research
and work more closely with industry. Such efforts to exploit the
outputs of the research base are aimed at increasing the UK's
industrial competitiveness, economy and quality of life. These
policies will inevitably mean that few researchers can be said
to be free of industrial associations, if indeed it were ever
possible to make such a claim. As the Sheffield Institute on Biotechnology
Law and Ethics told us, "it is difficult to see how any committee
performing a risk assessment or auditing one already done could
consist of other than experts in the field, who perforce cannot
be totally independent".
Industry and Government, rightly, will always seek to work with
the best scientists available. We reject any suggestion that
scientists' integrity is automatically compromised by association
with industry. If scientists from academia or the public sector
with research connections to the biotechnology industry were to
be barred from the Government's scientific advisory system relating
to GM crops and food the Government would be deprived of some
of the best scientific expertise available. We agree with Mr Rooker
that this would be "totally inappropriate".
52. Even accusations of partiality, however unfounded,
can damage public confidence in the advisory committees.
Scientific advisory committees need a means of handling interests
that will protect their members from unjustified claims of partiality
and help to restore public confidence. Advisory committees must
earn rather than assume public confidence or trust. Government
must support its advisers by making clear the checks and balances
which exist within the system to prevent partiality and to expose
it if it were to occur and by responding robustly to false accusations.
This support must be well informed. DETR claim that the high quality
of the advice from ACRE is demonstrated "by the fact that
there have been no incidents of damage to the environment in any
of the cases for which ACRE has advised on the conditions to be
attached to a consent" when only small scale trials have
so far been carried out shows that this is not always the case.
The scientists involved deserve better support than this. Professor
Beringer acknowledged that the existing requirements were not
stringent enough, telling us that, for the last two years, the
members of ACRE have argued that they "feel that the rules
on declaring interests are far too weak. The number of shares
[in a company that] you need to hold are far too high for most
academics even to be able to think of entering their interests".
We agree with the Institution of Professionals, Managers and
Specialists (IPMS) which argued that "serious thought ...
needs to be given by Government to establish clear guidelines
on disclosure of interest [for members of advisory committees]
backed by active policies of annual disclosure, clear and transparent
procedures for review of disclosures and clear criteria for decisions
on whether interests are material".
LAY MEMBERS ON ADVISORY COMMITTEES
53. ACRE membership includes an environmentalist
and meetings are also attended by an assessor from English Nature.
ACNFP membership includes a consumer expert and an ethicist. Many
witnesses commented on the roles of these 'lay members' on scientific
advisory committees. Professor Derek Burke, a former chairman
of ACNFP, told us that in his experience, the consumer representative
on ACNFP brought a "change in the way that the scientists
approached issues " and could "witness to the robustness
and independence of the Committee".
Both Mr Meacher and Mr Rooker felt that the role that lay members
played on scientific advisory committees was important, arguing
that lay representation served to increase public confidence and
transparency and to challenge scientific members to explain themselves
in ways which can be widely understood;
or as the Consumers' Association put it, to ensure that "risks
are communicated in a way that consumers can understand and act
We recognise that lay members add value to committee deliberations
by bringing alterative perspectives. The Chief Scientific Adviser
to the Government has explicitly set out the need "to involve
at least some experts from other, not necessarily scientific,
disciplines, to ensure that the evidence is subjected to a sufficiently
questioning review from a wide ranging set of viewpoints".
We agree. We recommend that such
individuals should make up a fifth of the membership of advisory
54. We are, however, concerned about the way in which
the role of lay members is defined and acknowledged. Like Mr Rooker
we consider that titles such as 'consumer representative' or 'ethicist'
which are sometimes applied to lay members are unhelpful.
Moreover, such titles may serve to give false impressions that
consumer and ethical interests should be addressed by scientific
advisory committees or that they have been adequately addressed.
Nor can we sanction the use of the term public interest member
which might give the erroneous impression that other members are
not appointed to serve the public interest. We recommend the
use of the term lay member to refer to experts from other disciplines
serving on scientific advisory committees.
55. The Chief Scientific Adviser, in The Use of
Scientific Advice in Policy Making, argues that wherever possible
departments should "ensure that data relating to the issue
are made available as early as possible to the scientific community
to enable a wide range of research groups to tackle the issue.
Scientific advance thrives on openness and competition of ideas".
Openness is certainly important in maintaining a high standard
of scientific debate and decision making; however, as a number
of witnesses argued, it is also an important factor in maintaining
a system which commands the confidence of the public.
Despite recent reforms on the part of the Government to increase
the transparency of both ACRE and ACNFP there remain some criticisms
of a lack of openness and demands for closer scrutiny. Sainsbury's,
for instance, told us of a perception that advisory committees
are "unnecessarily shrouded in mystery".
The Biotechnology and Biological Sciences Research Council (BBSRC)
and the Royal Commission on Environmental Pollution both argued
that the results of committee deliberations and the advice they
deliver should be placed in the public domain as a matter of routine.
56. ACNFP's agendas and minutes are placed on the
Internet and discussion papers are available on request. Assessment
reports and annual reports are published and "companies submitting
approval requests are strongly encouraged to deposit as much of
the supporting data as possible in the British Library".
MAFF is also considering publishing supporting data and assessment
reports on the Internet, "the intention being to invite comments
before the Committee offered its advice".
ACNFP has also experimented with public meetings when discussing
generic issues but not when considering applications. Indeed,
Professor Bainbridge was firmly of the opinion that it was not
feasible to have open meetings when the committee was considering
Similarly, ACRE now places all its minutes on the Internet along
with technical reports and other material, including a newsletter,
and the advice it delivers to Ministers is placed on the public
The BBSRC pointed to ACRE as a "good model" in terms
of transparency, although we note that ACRE has not held open
While we acknowledge the arguments made by some witnesses that
there would be practical difficulties for committees to operate
if all meetings were to be held in public, unnecessary denial
of access to meetings only serves to invite accusations that committees
are secretive because they are not doing their jobs properly.
We recommend that Government continues to drive for further
openness by publishing ACNFP and ACRE papers and data (in full
and summary form) and negotiating similar treatment of material
from similar committees in other EU states. Such information should
be published on the Internet for speed and accessibility as well
as by conventional means. Summaries should be provided in plain
English. We further recommend that, unless applicants can demonstrate
that disclosure would cause commercial harm, all future meetings
of ACRE and ACNFP should be held in public.
57. Some witnesses raised concerns about increasing
the ACRE's and ACNFP's openness on the grounds that the commercial
confidentiality of applicants could be compromised.
We also note the Consumers' Association view that "commercial
confidentiality can be used as an excuse to prevent the disclosure
Nevertheless, we recognise the genuine necessity to maintain commercial
confidentiality in certain circumstances. Although much of the
research behind applications will already have been patented well
before an application is made, details of procedure and process
can also be commercially valuable. Total disclosure requirements,
which would reduce the incentive for companies to invest, would
be inappropriate. We believe that there should be a presumption
in favour of public disclosure unless applicants can demonstrate
that disclosure would cause commercial harm.
63 Ev. p. 137 Back
Plants for Food Use, p. 3. Back
p. 138. Back
Protection Act 1990, Section 106(1). Back
to the Secretaries of State for Scotland and Wales as appropriate.
Separate, but similar, provisions apply in Northern lreland. Back
p. 135; POST, GM Foods, p. 23. Back
p. 136. Back
details, see "Commission Recommendation of 29 July 1997 concerning
the scientific aspects and the presentation of information necessary
to support applications for the placing on the market of novel
foods and novel food ingredients and the preparation of initial
assessment reports under Regulation (EC) No 258/97 of the European
Parliament and of the Council", Official Journal of the European
Communities, L253, 16 September 1997. Back
Scientific Committee for Food consists of up to 19 scientific
experts appointed by the European Commission. Back
pp. 64-5. Back
Report from the House of Lords Select Committee on the European
Communities, Session 1998-99, on EC Regulation of Genetic Modification
in Agriculture, HL II-I, para 60. Back
Response to the House of Lords Select Committee on the European
Communities, Second Report, Session 1998-99, on EC Regulation
of Genetic Modification in Agriculture. Back
p. 36. Back
Ev. p. 210. Back
p. 236. Back
p. 137. Back
p. 136. Back
p. 253. See also Ev. p. 34; Ev. p. 222. Back
p. 179. Back
Commissioner for Public Appointments' Guidance on Appointments
to Public Bodies, July 1998,
para. 3.68. Back
pp. 171, 2, and 198. Back
p. 198. Back
P. 171. Back
Q. 746. Back
p. 184. Back
Committee on Releases to the Environment Annual Report No 5: 1998,
DETR, published March 1999 Back
p. 1. See also for example Ev. p. 211; Ev. p. 242. Back
p. 211. See also Ev. p. 171; Ev. p. 242; Ev. p. 213. Back
p. 184; Ev. p. 198. Back
p. 182. See also Ev. p. 184; Ev. p. 191. Back
p. 102. See also: Ev. p. 199; Ev. p. 225. Back
p. 136. Back
p. 252. Back
p. 222. Back
p. 218. Back
Use of Scientific Advice,
para 6.iv. Back
Use of Scientific Advice,
para 6.v. Back
p. 171; Ev. p.191; Ev. p. 195; Ev. p. 192; Ev. p. 253; Ev. p.
p. 124. Back
p. 191; Ev. p. 195. Back
p. 138. See also Ev. p. 100. Back
p. 141. Back
p. 100. Back
submission to Government Consultation, February 1999. Back
p. 263; Ev. p. 100. Back
p. 216. Back