53. EC REGULATION OF GENETIC MODIFICATION
IN AGRICULTURE(2ND REPORT, SESSION 1998-99)
Memorandum from the Ministry of Agriculture,
Fisheries and Food
The Government welcomes this detailed report
from the Select Committee while the revision of Directive 90/220/EEC
is underway. The effective and timely revision of Directive 90/220
on the deliberate release into the environment of GMOs is a major
priority for the Government. It offers the opportunity to reinforce
the existing legislation to secure full protection for human health
and the environment, while providing a stable and predictable
regime which will maintain UK and EU competitiveness in the commercial
exploitation of biotechnology and genome research. The report
makes an important contribution to the intense debate on the regulation
of genetically modified organisms (GMOs) in agriculture in presenting
a balanced and considered perspective on the key issues surrounding
the application of biotechnology in agriculture and food production.
The Government particularly welcomes a number
of the Committee's recommendations. Rigorous and wide-ranging
assessment of risks to the environment and human health must continue
to form the foundations of the regulatory process. The Government
is committed to ensuring that risk assessment provisions are strengthened
and extended to include indirect and delayed effects. The Government
also supports the Committee's recommendations on monitoring. This
will allow a clear picture to be built up of the environmental
effects of GMOs, and enable the assumptions in the risk assessment
to be verified.
The Government welcomes the Committee's recommendations
on labelling and the thresholds at which labelling should be required.
The Government is pressing the European Commission to develop
proposals on labelling and especially thresholds, and is pleased
to see additional support for these issues.
Significant progress was made on the revision
of the Directive by the Austrian Presidency. The UK was supportive
of many of the broad positions in the final text sent to the Environment
Council in December 1998, while recognising that some detailed
work remained to be done on the text. At the Council, Ministers
agreed to introduce new provisions on risk assessment and monitoring
with immediate effect, in response to public concern over genetic
The European Parliament adopted its first reading
Opinion in February 1999. The Government welcomes the Opinion,
and supports the Parliament's call for moves to reach a common
The recommendations in italics refer to Part
4 of the Select Committee's Second report in the 1998-99 session
and are referred to by number.
172. Biotechnology in general and genetic
modification in particular offer great potential benefits to agriculture,
industry, consumers and even to the environment. We consider that
GM technology may offer much to organic systems, for example through
reduced inputs (paragraphs 65-72, 78).
The Government agrees that the technology holds
potential net benefits and we believe it should be allowed to
proceed, subject to Government securing sufficient evidence to
be confident that the genetic modification will not be detrimental
to human health and the environment. We have yet to see any genetically
modified (GM) crops grown commercially in the UK and must wait
to see whether they will result in a reduction in agricultural
inputs, but we recognise that this is the aim of some genetic
modifications, and could bring benefits for the environment, if
The Government notes with interest the view
that genetic modification technology offers benefits to organic
systems in terms of the potential to reduce pesticide and fertiliser
inputs. However, this perception is not shared by most organic
farming organisations. Their position is that GM crops have no
role to play in their farming systems, and statements based on
this position have been incorporated in the UK Register of Organic
Food Standards for both production and processing. Furthermore,
the draft EC Regulation amending Council Regulation 2092/91 on
the organic production of agricultural products and foodstuffs,
including livestock production, proposes a complete prohibition
on the use of GMOs, and their derivatives at any stage in the
production of organic food, with the exception of their possible
use in veterinary medicinal products. This prohibition has received
the support of all Member States and the European Parliament.
Nevertheless, the Government believes that genetic
modification and organic farming will have to find a modus vivendi.
The Government is offering substantial support towards organic
farming and is concerned that the introduction of GM crops into
agriculture should not compromise organic production. It has therefore
urged the proponents of the growing of GM crops here in the United
Kingdom to address the issue of the interface with other crops,
including organic crops, through specifying separation distances
and consultation with neighbouring farms where appropriate.
173. There are potential risks relating to
the environment, including the impact on ecosystems of out-crossing,
pest resistance and stress and multiple tolerances (paragraphs
The Government fully recognises that there are
potential risks. No GMO may be released into the environment unless
an environmental risk assessment has been carried out and reviewed,
and a consent issued by the Secretary of State which sets the
conditions of release. The environmental risk assessment takes
into account the effects on ecosystems of outcrossing, any stress
or multiple tolerances, and the development of pest resistance.
The revision of Directive 90/220 aims to establish
common principles for risk assessment to include both direct and
indirect effects and to require post-market monitoring to ensure
that the potential environmental risks are rigorously addressed.
While the revision of the directive is underway, European Environment
Ministers agreed last December to use the flexibility within the
existing directive to introduce strict new principles for risk
assessment and post-market monitoring, with immediate effect.
174. We consider that environmental risks
and benefits should be assessed at the same time (paragraphs 87-88).
Safety to human health and the environment is
the primary goal of the regulatory system. Under the current regime,
releases of GMOs are judged solely on the basis of an assessment
of the risks to human health and the environment. The regime does
not permit the decision on whether to grant a consent to take
into account the offset of any risks by benefits.
There may be benefits to biodiversity from the
planting of certain GM crops, where they may replace more damaging
practices in conventional agriculture. We are currently considering
the wider issues of GM crops with respect to how biotechnology
fits into agriculture and our commitments to enhance biodiversity
on farms. The Government's Advisory Committee on Releases to the
Environment published a discussion paper on 18 February on the
Commercial Use of Genetically Modified Crops in the UK: the Potential
Wider Impact on Farmland Wildlife.
175. The risks involved in genetic modification
can, we believe, be controlled, if a strict risk management process
is in place. A clear, coherent set of principles for environmental
impact analysis is needed which allows for consistent interpretation
by Member States (paragraphs 89, 92-93).
The Government agrees that environmental risk
assessment and strict risk management is the key to the safe use
of GMOs. The current Directive requires a risk assessment to be
carried out on a case-by-case basis before every release, but
contains no specific provisions on how this should be done. The
UK has encouraged the development of risk assessment guidelines
in the Community for a number of years, and has issued risk assessment
guidance to applicants for several years. Although no agreement
has yet been reached on the amendment of the Directive, EU Environment
Ministers agreed last December to introduce common principles
for risk assessment, as noted above.
The Government considers that a common approach
to risk assessment would help to ensure a thorough and harmonised
appraisal of the risks that each GMO may pose to human health
and the environment. It would also help to increase the standard
and quality of notifications submitted and ensure that competent
authorities take a more harmonised approach to the appraisal of
notifications, thereby helping decision-making at Community level
and avoiding the long delays in issuing decisions experienced
over the past years.
For these reasons, we welcome in the proposed
revision of the Directive the specific inclusion of an annex on
risk assessment. General priciples of risk assessment are being
developed in the course of the negotiations which will promote
consistent implementation in the Member States.
176. We recommend that risk assessment should
include direct, indirect, immediate and delayed effects. The regulatory
system should attempt to predict interactions. A system which
attempted to identify an integrated approach would be preferable
to what amounts to a first come, first served approach (paragraphs
The Commission's proposal for the amendment
of Directive 90/220 requires risk assessments to take account
of direct and indirect, and immediate and delayed, effects of
GMOs. The Government fully supports the inclusion of the indirect
and cumulative effects in risk assessment requirements in the
new Directive, and is committed to taking account of the broader
environmental impact of each release before issuing a consent.
The indirect effects of GM crops on non-target
species are already considered in the current regulatory regime
where those effects may occur as a result of the crop itself.
The current regime also addresses cumulative effects by considering
the effect of a new GMO together with any interactions it might
have with GMOs approved previously. This is particularly relevant
in the case of herbicide-tolerant crops. The Government believes
that cumulative effects should be made explicit in the context
of risk assessment in the revised directive and is pressing for
this. The combination of these changes would provide an integrated
177. In assessing risk, we recommend that
modified plants and their management schedules should be compared
with the use of a similar non-modified crop and best agricultural
practice (paragraph 90).
The risk assessment is always based on a comparison
of the modified plant with the non-modified plant from which it
is derived. The Government agrees that the overall assessment
of risk needs also to take into account environmental effects
of any change in agricultural practice that is likely to be necessary
as a result of planting a GM crop.
178. We recommend that there should be triggers
other than genetic modification which bring the assessment and
management system into action, as is the case for novel foods.
We recommend that, from now on, any crop with novel traits which
may have the potential to impact significantly on the environment
should be subject to an oversight system (paragraph 91).
The Government recognises that regulating on
the basis of process rather than product could lead
to anomalies. For example, crops can be bred by traditional means
to express herbicide tolerance in a similar manner to that expressed
as a result of genetic modification; indeed such crops are already
grown commercially in Canada. The Government considers it right
that the focus is on the genetic modification of organisms since
this can result in the crossing of species barriers where risks
have to be particularly carefully assessed and managed. The EC
legislation on GMOs reflects this view.
The Government recognises however that this
matter would benefit from further examination and will ask ACRE
to advise on what might be done to address the issue raised by
179. The knowledge of how a crop grown on
farm and commercial scales will interact with the environment
can only be acquired by growing it on such scales. Large scale
trials are needed. We consider that an outright moratorium would
be inappropriate (paragraphs 96-99).
The Government is confident that the regulatory
control of the risks from GM crops themselves, based as it is
on risk assessment and the step-by-step approach, will ensure
the environment is protected. However, there is an additional
safeguard in the Directive which allows a Member State provisionally
to stop the marketing of an authorised product where there is
evidence of environmental harm. The Government agrees that a general
moratorium is unnecessary and would be unhelpful, and believes
that in any case imposing one unilaterally would be unlikely to
stand up to legal challenge.
The Government is taking seriously concerns
raised by English Nature and others that the widespread introduction
of some types of genetically modified crops could bring changes
to the agricultural environment which may be damaging to farmland
wildlife. Last October, the Government announced a managed development
programme agreed with the plant breeding industry to address these
concerns. We shall continue with research releases and farm-scale
plantings in order to build up a fuller picture of the environmental
effectseither positive or negativeof GM crops. This
could not be achieved with a moratorium.
180. We welcome the ability to set specific
conditions for each commercial release. We are however concerned
that the draft Directive does not envisage an end-point at which
the GM crop is considered safe enough to be released into the
environment without such constraints (though perhaps with certain
management conditions) (paragraphs 100-101, 170).
The Commission's proposal sets a seven year
fixed period for consents. The UK has serious reservations about
automatic time-limitation, although the Government is prepared
to accept the principle, with the longest possible period, to
ensure agreement is reached on the amendment. The Commission proposed
a separate procedure for renewing marketing consents for further
periods of seven years. We consider that the need for time limitations
where consents are renewed should be considered on a case by case
181. Conditions and regulations should only
be imposed where necessary, but must be adhered to when imposed.
The general conditions may best be established through a (preferably
pan-European) government-sponsored code of practice. It may be
the case in this instance that a voluntary code of practice will
not be sufficient; if so, the code of practice should be backed
up by regulation (paragraphs 105-107).
Conditions and regulations which form part of
the consent are enforceable as part of the regulations. The proposed
amendments to Directive 90/220 includes requirements such as post-market
monitoring (which Member States have agreed to introduce now)
and the provision of information to the public. We support these.
The Government has agreed with the plant breeding
and farming sectors in the industry group SCIMAC (Supply Chain
Initiative on Modified Agricultural Crops) a programme of managed
development of herbicide tolerant GM crops whereby the first farm-scale
plantings are strictly limited and monitored for ecological effects
along with comparable plantings of conventional crops.
SCIMAC has also drawn up voluntary guidelines
on the growing of herbicide tolerant crops. These seek to ensure
best farming practice through, for example, separation of GM and
non-GM crops, product identity and record keeping. Once the crops
get to the point of commercial release, there will be industry
sanctions to ensure the point of commercial release, there will
be industry sanctions to ensure compliance, including withdrawal
of access to GM crop varieties for serious breaches. The arrangements
will complement the requirements of Directive 90/220 under which
a consent can be modified or withdrawn if necessary. They will
be backed up by a system of independent audit.
182. Monitoring is not a substitute for
risk assessment but can complement it. We consider that those
involved should report on any predicted effects which do not occur
and any unexpected events which do occur. We recommend that monitoring
(to Community-wide standards) should be performed by an independent
organisation, funded through levies on applicants. There must
also be a Community-wide audit of enforcement as monitoring standards
(in many fields) have in the past been subject to too great a
variation (paragraphs 102-104).
The Government strongly supports the proposals
for amending Directive 90/220 to incorporate requirements for
monitoring commercial releases. Monitoring requirements, based
on risk assessment, would be set out on a case-by-case basis with
each marketing consent and enforced by the relevant competent
authority. As mentioned above, pending the revision of the Directive,
the European Environment Ministers agreed last December to require
stricter monitoring provisions under the existing Directive, based
on monitoring requirements in the amending Directive. This requirement
is currently being implemented in the UK.
The competent authority reviews the notifier's
proposed monitoring as part of the assessment of the notification.
Consent holders may carry out monitoring themselves or contract
independent organisations to do it for them. The methodology for
the proposed monitoring and the results of the monitoring are
subject to review by the competent authority (and in the UK by
ACRE); adjustment, or under the revised Directive, renewal, of
the consent takes the results of that review fully into account.
The Government believes that such control, together with the regular
meetings of the competent authorities, will help to secure sound
monitoring across the Community. The Government considers that
the financial responsibility for monitoring commercial releases
lies with the consent holder.
183. We consider the regulatory process for
assessing the safety of novel foods to be thorough and proper
and we see no reason to doubt the safety of foods which have been
approved by the regulatory process. The emphasis should not be
on "genetically modified" but on the new characteristics
of any individual product (paragraphs 109-116).
The Government welcomes this conclusion. Although
the regulatory process considers the method of production, the
main focus is on the safety of the product as sold to the consumer.
The experience gained through assessing individual applications
is used to inform subsequent assessments and is built into periodic
reviews of the regulatory procedures. The Advisory Committee on
Novel Foods and Processes keeps a very close watch on emerging
science and takes account of this in its safety assessments. The
Government is therefore satisfied that all GM foods currently
approved for sale in the UK have been rigorously assessed and
judged, on the basis of extensive scientific knowledge, to be
as safe as their non-GM counterparts for all sections of the population.
The Government is still committed to exploring options for the
post-market monitoring of GM foods.
184. Antibiotic-resistant marker genes should
be phased out as swiftly as possible. Research needs to be conducted
into how best to consider applications involving genes without
proven track records of food use. We support the call for the
accumulation and sharing of national data to assist regulators
(paragraphs 75, 109-116).
The Government encourages companies to develop
alternatives to antibiotic resistance marker genes (ARMs) and
to develop methods to jettison those used where they are not an
essential part of the final food. The safety of ARMs is considered
on a case by case basis taking into account an assessment of the
clinical use of the antibiotic; the likelihood of transfer of
the antibiotic resistance gene into, and expression in, gut micro-organisms;
and the toxicity of the gene product. The potential cumulative
effect of ARMs in different products is also taken into account.
The ACNFP has published two reports on the use of antibiotic resistance
marker genes in genetically modified food organisms and keeps
a very close watch on developments.
185. Internal work at MAFF to prepare for
the Food Standards Agency is poor substitute for its launch. We
would be encouraged if legislation were to be brought forward
in this Session (paragraphs 118-122).
The Government intends to establish the Food
Standards Agency at the earliest opportunity, and the necessary
legislation will be given priority if extra time becomes available
in the present Parliamentary session. In the meantime, the Government
has published a draft Bill for full public consultation. The draft
Bill has also been subject to pre-legislative scrutiny by an ad
hoc Select Committee of the House of Commons to help ensure
that it is of a high quality when it is introduced in Parliament.
186. Genetic modification does not concern
a single product or variety but will soon affect the whole spectrum
of agriculture. To require traceability for all agricultural commodities
would be an exceedingly costly exercise for little benefit, especially
when there is no anticipated risk to human health (paragraph 117).
Requiring full traceability for imported commodities,
where these have already met EU food safety requirements, could
also be challenged as a contravention of our obligations under
the World Trade Organisation.
187. Once the regulatory process has ensured
safety, the success or failure of the technology must be left
to consumer choice in the marketplace. The two issues involved
in providing choice are the supply of GM and non-GM products and
labelling (paragraph 128).
The Government is determined that all foods
that contain GM material should be clearly labelled to facilitate
consumer choice. The UK has campaigned hard in Europe to secure
better labelling of GM foods. A Regulation on the labelling of
GM soya and maize, came into force on 1 September. Regulations
enforcing this EC regulation recently came into effect in Great
Britain. These GB regulations also extend the labelling requirements
to establishments selling non-prepacked foods such as catering
premises. These requirements will enable consumers to choose whether
or not to eat foods containing genetically modified material.
But choice also depends on having alternatives. To assist in this,
in March 1998, the Government published a list of companies offering
non-GM soya. This list currently contains details of some 59 suppliers.
The intention was to facilitate the ability of the market to respond
to any perceived demand for non-GM supplies.
188. Segregation must be driven by the market
and not required by Government. Producers and manufacturers should
however be under no illusion as to the climate of consumer opinion
in Europe and it would be advisable for the immediate future for
segregation to occur to facilitate consumer choice. The identity
preservation system is to be commended. The crop and product must
still be subject to the standard testing and labelling regimes
as GM material has often been found in supposedly unmodified shipments
The SCIMAC managed development programme described
above will guarantee segregation and clear labelling throughout
the supply chain of all GM crops grown in the UK.
The Government appreciates the difficulties
associated with obtaining the segregation of GM and non GM crops
on a large scale. This does not alter the Government's view that
segregation would have been a better way to introduce GM crops
into the UK market.
This said, the labelling regime which is now
being introduced will in effect ensure the identity of products
and many suppliers will choose to keep GM and non-GM products
separate to satisfy consumer demand. With effective labelling,
the ability of enforcement authorities to test label claims, and
the availability of non-GM alternatives, consumers will be in
a position to purchase products which best suit their needs. Indeed
as indicated below there is evidence that the market is already
responding to consumer demand for non-GM alternatives.
The Government is satisfied that all GM foods
currently on sale have been subject to a rigorous safety assessment
and consequently considers that there are no safety concerns to
warrant imposing segregation as a condition of approval. On this
basis we believe that any attempt to impose segregation as a condition
of import would not be defensible under WTO rules.
The Government recognised that to facilitate
consumer choice there was a need to encourage the development
of an alternative market in non-GM ingredients. As indicated in
the response to conclusion 187 the Government has facilitated
the development of such a market. There is already evidence that
several large supermarket chains are now obtaining their ingredients
from suppliers offering identity preservation systems. They will
nevertheless need to ensure that food containing these ingredients
can comply with the labelling rules as currently drafted.
189. We welcome the requirement for the explicit
labelling of GM products in order to help provide consumer choice.
We agree with the Commission and Government that only products
where the transgene or its product are detectable should be labelled.
To demand labelling where such detection is impossible would be
meaningless. A Community list of products which do not require
labelling is urgently required (paragraphs 135-139, 145).
The Government welcomes this conclusion, indeed
it is determined to ensure the clear labelling of foods containing
GM ingredients to enable consumers to make informed choices. In
respect of the creation of a list of products which do not contain
GM material from GM soya or maize and therefore do not require
labelling, the Government is pressing the European Commission
to bring forward a proposal as envisaged in EC Regulation 1139/98
as a matter of urgency. The Government understands that the Commission
is currently awaiting advice on this from the EC Scientific Committee
190. Any ingredient or additive to a product
should be identified as GM when the presence of GM material can
be detected above an established threshold. No labelling should
be required below the threshold. Additionally, if a finished product
contains GM material above a threshold the product itself should
The Government is pressing the European Commission
to develop detailed labelling rules for additives as a matter
of urgency. A first draft of a proposal is expected later this
month. It is anticipated that this will take the form of a Commission
regulation made under the food labelling directive 79/112/EEC
and will follow the approach contained in regulation 1139/98 by
requiring labelling based on the presence of GM material (protein
or DNA). The Commission is also developing a proposal for a de-minimis
threshold such that adventitious contamination of a non-GM supply
below a given threshold will not require labelling. However, where
GM material is present above such a threshold it will still need
to be labelled.
191. The absence of a testing and thresholds
policy is a serious gap in current European and domestic legislation.
Until a Community policy is agreed we recommend that MAFF should
issue interim guidelines. A workable but cautious threshold for
GM presence would perhaps be 2 per cent (paragraphs 136-139, 141-144).
The Commission is actively developing a proposal
for a de minimis threshold for labelling. The Commisson
has indicated that it intends to come forward with a proposal
by the end of March. The proposal is based on the concept that
non-GM, supply in which low levels of adventitious GM material
are present will not require labelling if this is below an agreed
level. The Government agrees that a threshold is a necessary measure
to avoid a proliferation of GM labelling where all reasonable
attempts have been made to ensure that the material being used
is non-GM. Representatives from a majority of member states agree
that a figure of 2 per cent is a reasonable limit given the specificity
of current detection methods and the Government is considering
this and whether such a threshold would be acceptable to consumers.
We are however, of the view that any agreed figure should be seen
as a maximum limit and that producers should continue to endeavour
to keep well below this figure by following best practice in the
cultivation, transport and processing of crops.
192. Information supplementary to that provided
on the label of GM foods must be available to the consumer. We
recommend that Member State governments co-ordinate (but not necessarily
be responsible for) the establishment within each State of a source
of information regarding GM foods, to which the consumer may resort
for information not provided on the product label. In the United
Kingdom, this should as soon as possible fall under the remit
of the proposed Food Standards Agency (paragraph 140).
The Government encourages the provision of additional
information to enable consumers to make informed choices.The Government
is also committed to an open and transparent approval system,
where decisions are no longer made behind closed doors. The Minutes
of the ACNFP are already published on the internet together with
detailed agendas and committee papers. Applicants are also encouraged
to deposit the data which supports an application in the British
Library. The Government is currently considering what additional
steps can be taken to open up the system still further whilst
recognising that rules on data confidentiality need to be developed
at community level.
The Government is currently updating the Food
Sense leaflet on genetically modified food to take account of
recent developments in legislation.The ACNFP has recently produced
a corporate brochure containing details of how the Committee assesses
products and when foods were approved.
193. It is highly desirable that there should
be competition between a sufficient number of agro-chemical/seed
companies on a world-wide basis. We consider that consolidation
should not progress any further (paragraph 85).
The Government notes the Committee's comments
on consolidation in the agrochemical sector. Where mergers or
acquisitions involving agrochemical companies quality for investigation
under either UK or EC competition jurisdiction, they will be given
careful consideration on their individual merits. In assessing
the effects of a merger under either domestic or EC procedures,
the effect on competition and the degree of consolidation within
the sector are factors which are generally taken into account.
194. Provided that the farmer can afford
any extra costs, we do not consider either the licensing of the
right to plant or the sale of seeds which will produce sterile
crops to be a problematic development (paragraph 86).
The Government agrees broadly with the Committee's
conclusion as to the growing of these crops in the developed world.
No farmer should be forced to grow these crops, though if the
market finds that they fulfil the claims made for them, there
is likely to be a commercial incentive to do so. Licensing of
the right to plant will add to the environmental safeguards on
their production, while use of seeds which will produce sterile
plants will help to prevent gene transfer.
195. The regulatory process should only judge
products on safety: ethical questions should be addressed before
regulation, not during or after. In the same way as agreeing the
principles for risk assessment, the Council of Ministers will
need to agree on how to deal with potentially ethically sensitive
modifications such as the inclusion of animal or fish genes in
crops. The market might be a suitable arbiter. For some people
the use of GM products to any extent is an ethical issue (paragraphs
The Commission's proposal for the revision of
Directive 90/220 contains a reference in the preamble to the possibility
that the Commission may consult its ethics committee on general
matters. The Government fully endorses the view that ethical questions
must be addressed with regard to GMOs, and fully supports the
Commission's proposal. We believe that in the context of the Directive,
ethical questions should be treated generically rather than as
a part of the review of each notification.
In addition, there are a number of committees,
including the ACNFP, in the UK which have ethical experts amongst
their members and are therefore equipped to take account of ethical
issues when advising Ministers. The Government is acutely aware
that some people do not wish to use GM products and so is committed
to providing information to allow consumer choice. Under the EU
novel foods regulation there is a requirement to label food containing
GM material not present in conventional counterparts that gives
rise to ethical concerns. This requirement is based on a recommendation
by the Polkinghorne Committee that food from GM crops should be
labelled to indicate whether ethically sensitive genes have been
The question of whether ethical issues are fully
addressed by the current regulatory frameworks being considered
as part of the review referred to in response to conclusion 198.
196. The destruction of trials of GM crops
by certain groups fundamentally opposed to the technology must
be condemned, but increasing confidentiality is not the answer.
The advisory committees should continue to place as much information
as possible in the public domain. We welcome the Commission's
proposal to do the same at Community level. We agree that public
comment should be taken into account formally before ACRE makes
its recommendation, rather than informally as at present. Transparency,
however, must not affect the efficient working of the regulatory
committees (paragraphs 123-125).
The Government is fully committed to providing
public information and to a transparent and open regime. For this
reason, the applications for releases of GMOs, and the full dossiers
of supporting information including trial locations are open to
public inspection. It is regrettable that this important element
of transparency in the regulatory process has been abused. The
agendas, reports and minutes of ACRE are all available for public
inspection on the DETR-ACRE website, along with a range of supplementary
information. In addition, the establishment of a stakeholder forum
to discuss the environmental aspects of GM crops is under consideration
by the Government.
The revision of Directive 90/220 provide an
opportunity to make the regulatory procedures more transparent
at European level, and the Government has pushed strongly for
this. The European Parliament has, in its first reading, called
for public consultation to take place within the timetable for
Public comment on individual applications for
consent to release GMOs is already taken formally into account
by the competent authority. When relevant scientific information
is submitted to the authorities, it is referred to ACRE.
197. We do not question ACRE's integrity,
but it and its members must be seen to be acting independently.
The remit of ACRE should be adjusted so that it considers, for
example, indirect and cumulative environmental effects when judging
individual applications (paragraphs 148-150).
The Government recognises the high quality of
the advice received from ACRE. Under the chairmanship of Professor
John Beringer, ACRE has provided expert advice on over 160 applications
to release genetically modified organisms since February 1993
when the current regulations came into force. ACRE's advice is
independent of any interference from Government or influence from
industry or pressure groups.
The Government has already acted upon criticism
that ACRE's remit is too narrow. Until recently, within the terms
of the current regulatory framework ACRE only offered advice on
the direct and indirect impact of genetically modified organisms
on the environment and human health. The remit of ACRE has now
been extended so that the committee also considers the wider indirect
effects, such as changes in agricultural practice, subsequent
and consequent effects on biodiversity, and cumulative effects.
198. We believe that a new committee, similar
to that proposed by the Royal Society, is needed to examine more
general issues which arise from the use of genetic modification
in agriculture and to co-ordinate and plan policy as a seamless
whole (paragraphs 151-153).
The Government recognises that the Committee
structure set up some years ago may not provide the full range
of advice needed in today's climate. The Government is therefore
undertaking a thorough review of the framework for overseeing
developments in biotechnology, focusing particularly on the range
of committees that have been established to provide the Government
with expert advice and to regulate in this area. The Government
is also engaged in a public consultation on developments in the
biosciences which is due to report in Spring 1999. The review
of the framework for overseeing developments in biotechnology
will report at the same time.
The Government seeks to have in place a system
that provides sound advice and proportionate regulation and is
at the same time as simple and transparent as possible; that has
the flexibility to respond to the fast moving developments in
the technology and to public concerns; and that commands the respect
of users and the public. The review is assessing the current system
in the light of these criteria. It seeks to address the following
what gaps exist in coverage of biotechnology
by the existing committees and how might these be remedied?
what overlaps exist and are they
justified? If not, how might they be remedied?
could the current system be structured
in a more simple way?
how could the system for providing
advice to Government be made more transparent?
are ethical and other wider issues
addressed fully and properly within the current system?
are stakeholders given the appropriate
opportunities to make their views known? For example, would an
environmental stakeholder forum be a valuable addition to the
is the framework flexible enough
to cope with the rapid development of this technology which is
likely in the future?
does the public have confidence in
the system currently in place?
199. Domestic pressures, ecological and
agricultural conditions vary across the Community. We consider
that Member States should have the right to opt-out of growing
certain GM crops for domestic or environmental reasons. The products
of such crops, food or other, should however be available throughout
the Community and the market will determine their acceptability
and so success or failure (paragraph 160).
The Government's overriding concern is that
human health and the environment should be properly protected.
The statutory procedures under Directive 90/220 and the managed
development arrangements with ecological monitoring, should ensure
that this is the case for GM crops grown in the UK. Provided that
no problems arise, the Government sees not reason for Member States
to impose additional restrictions, and agrees that the market
will decide which crops are grown. The legality of allowing a
Member State to restrict growing of a product which could be imported
from another Member State would need careful consideration.
200. We consider that consultation of the
Commission's scientific committees will be useful for resolving
inter-Member State disputes. The appointment membership and operation
of the committees must be open to scrutiny. The current method
of appointment is inadequate. The structure of the committees
could also be streamlined to increase their relevance to the regulation
of GM releases. The committees require improved resources in Brussels
A new article in the Commission's proposal for
the revision of Directive 90/220 requires the Commission to consult
one or more EC scientific committees on any matter which is likely
to have effect on human health and/or the environment before the
decision procedure is initiated. A similar provision already exists
in the EC novel foods regulation. Scientific committees have been
used under the current directive to seek additional expertise
on marketing applications where there has been no clear consensus
among Member States. However, ACRE will continue to review in
depth the environmental risk assessments submitted as a part of
each notification and there is no question of this responsibility
being transferred to the EC scientific committees.
The Government supports consultation of the
European Commission's committees in principle. However, clarification
is needed about exactly when and how a Committee should advise.
Many Member States, including the UK, consider that the scientific
committees should only be consulted if there has been an objection
to the marketing, or if the safeguard clause has been invoked.
This would avoid unnecessary duplication of effort. In the context
of novel foods the UK is encouraging the competent authorities
to formulate specific questions for the Scientific Committee for
Food when addressing objections raised by Member States. Many,
again including the UK, also support fixing the length of time
allowed for consultation of the scientific committees to ensure
that there is a clear, effective and predictable consultation
The entire system of scientific advice used
by the Commission in the field of consumer health and food safety
was reformed in 1997, and the Government understands that the
appointment and selection procedures are now open to scrutiny.
The committees are composed of scientific experts appointed by
the Commission following the publication of a call for expressions
of interest and a selection procedure to identify the most suitable
applicants. The resourcing of the committees is a matter for the
Commission. The Government agrees that the scientific committee
system needs to be as transparent as possible and welcomes recent
moves by the committees to publish their advice on the internet.
The Government understands that the Commission is considering
the need for increased support for the scientific committees.
The Government will monitor the performance of the scientific
committees and call for review where appropriate.
201. We welcome the introduction of strict
time limits and the definition of risk assessment which should
help end discrepancies between Member States and provide the predictable
system desired by industry. There are however two flaws. The first
is too ready a willingness to stop the clock. We consider that
the efficiency of the scientific committees' working should be
improved before resorting to stopping the clock. If this proves
impossible, consideration will need to be given as to whether
it would be preferable to make the committees permanent or to
stop the clock. Additionally, the Commission has failed to set
itself a time limit for approving or rejecting a release following
the (in)decision of the Council (paragraphs 165-168).
A number of difficulties with the regulatory
system have led to delays in approvals over recent years. This
has generated an uncertain and inconsistent environment for industry
and agriculture. Sufficient time must, of course, be allowed for
a thorough scrutiny of applications, but the current regime has
permitted unacceptable delays at many stages of the process. The
UK is therefore pressing strongly for fixed time periods for each
stage in the decision-making process.
The Commission's proposal for the revision of
Directive 90/220 tackles this problem on two fronts. Firstly,
time limits are to be introduced for nearly every stage of the
process, including those dealt with by the Commission which has
been responsible for many of the delays in the past. Secondly,
clarification of the scope of the directive and risk assessments
should lead to fewer delays as implementation will be less uneven
across the Community, so necessitating fewer objections from Member
States to marketing applications on weak grounds. The introduction
of a timetable, if strictly applied, should solve these problems
while continuing to provide for rigorous assessment of risks.
We are confident that these measures will make
the regulatory process less prone to delay, and equally importantly,
they should make the system more consistent and predictable. The
Government believes that the Committees should work within defined
periods; stopping the clock is not appropriate.
202. We find no merit in the proposal to
limit marketing consents to seven year periods (paragraph 170).
The Government has serious reservations about
automatic time-limitation of consents since it cannot be justified
generally on scientific grounds and may introduce a degree of
uncertainty for applicants and consent holders. We are prepared
to accept the principle in order to ensure agreement on the revised
Directive as quickly as possible, but wish to see the longest
period which should be on a case-by-case basis up to a maximum
of 15 years. It is important to remember that where there are
strong reasons for a shorter period, this can be accommodated
in individual consents.
203. GMOs need to be regulated, at least
until our knowledge develops further, but it would be extremely
damaging if Europe's access to this technology was subjected to
inappropriate impediments (paragraph 171).
The Government's position, as laid down in our
domestic regulations, and as argued in European and international
negotiations, is to recognise that the environment and human health
must be protected while ensuring that a stable and predictable
climate exists for the biotechnology industry. The Government
agrees that there can be no question of a free for all. However,
it is important to recognise that this technology has the potential
to bring considerable benefits to farmers, consumers and the environment,
and that Europe should not be denied access to them.
204. The Committee considers that the proposed
revisions to the EC regulation of genetic modification in agriculture
raise important questions to which the attention of the House
should be drawn, and makes this report to the House for debate.