Supplementary Memorandum by the Ministry
of Agriculture Fisheries and Food and the Department of the Environment,
Transport and the Regions, and on behalf of The Scottish Office
and The Welsh Office.
11. Is segregation something which should
be left to the market, or is there a role for government? What
about traceability? Is it feasible, desirable or indeed essential?
Earlier this year, MAFF published a list of non-gm soya suppliers.
To what extent does MAFF go to ensure that this soya is indeed
non-gm. Is this a justifiable role for government? Iceland is
sourcing their non-gm soya from Brazil. Do you believe that Brazilian
soya is indeed non-gm?
All GM varieties for use in Europe have been
approved following a full safety assessment. Imposing segregation
as a condition of approval would breach the TBT Agreement because
it would be more trade-restrictive than is necessary to meet its
objective (since consumer choice can be assured by requiring labelling,
which is less trade-restrictive than segregation). Equally mandatory
segregation could not be defended using the SPS Agreement, because
it would not be a measure to protect health (since a product that
is approved for marketing has already been assessed to be safe).
The Government recognises that there is a demand for supplies
of non-GM ingredients and market forces are responding to this
by means of identity preservation at a commercial level. Indeed
there is already evidence that this is happening, for example
Iceland Frozen Foods are offering non-GM products, other supermarkets
are also moving in this direction. MAFF recently produced a list
of non-GM suppliers to help smaller companies. This list now stands
at 57 suppliers. However, the Government has made it clear from
the outset that it is for companies to satisfy themselves that
the product that will be supplied is likely to meet their requirements
before placing orders. The role of the Government is to ensure
that the necessary legislation exists to check that foods are
correctly labelled where they contain GM material and that this
is appropriately enforced.
The Government is aware that Iceland Frozen
Foods is sourcing some of its soya from Brazil. As yet Brazil
is not growing GM soya commercially, however, soya crushing plants
in Brazil are known to process US soya in order to operate at
full capacity. The Government understands, however, that Iceland
obtains its Brazilian soya from an inland area and that they also
have procedures in place to ensure that the processing plant does
not process GM soya.
12. What is the latest state of the Council
negotiations on labelling? Is this the final word on the subject?
If not, what remains to be negotiated? Should labelling go further
than stating that a product is GM, and state the purpose of the
modification, as is the case in Canada? What should be labelled
(DNA, protein)? Should labelling on foods be required to the extent
that the labelling can be verified by testing? What thresholds
should be set?
The EC novel foods regulation 258/97 came into
effect on 15 May 1997. In addition to requiring a pre-market safety
assessment this regulation contains specific labelling rules for
novel foods which apply in addition to existing Community labelling
requirements for foodstuffs as set out in Directive 79/112/EEC.
The Council regulation 1139/98 on GM soya and maize labelling
comes into effect on 1 September. The regulation requires labelling
based on the presence of novel protein or DNA and is consistent
with the labelling rules in the novel foods regulation 258/97
where a food is labelled if it is no longer equivalent to a conventional
counterpart. Member States agreed unanimously that the presence
of novel protein or DNA should be the trigger for labelling. To
improve transparency a "negative list" is being developed
of food ingredients that do not contain novel protein or DNA.
In addition discussions will continue on the practicality of setting
a de minimis threshold to ensure that labelling is not
triggered by very low level adventitious contamination. In agreeing
the text Member States also invited the European Commission to
encourage the development of validated methods for the detection
of protein or DNA resulting from genetic modifications.
The Government is aware of the Canadian proposal
for labelling issued in April 1997 which includes a provision
for voluntary positive labelling to indicate that a novel food
has particular attributes resulting from genetic modification.
This is consistent with the labelling of tomato puree in the UK
which includes a voluntary description of why the tomatoes were
modified. Under the Canadian proposal where there is compositional
difference or a health or safety issue which triggers mandatory
labelling, then that labelling will require identification of
the attribute rather than the fact that the product has been genetically
modified (e.g., high laurate canola).
The Government recognises that in many cases
a company will wish to indicate why a product has been modified
and this is allowable under the legislation.
13. Do you have any proposals for improving
public confidence in the regulatory system? MAFF would appear
to have lost the confidence of the public, Brussels has a poor
public image, the regulatory committees are invisible. Is greater
transparency part of the answer? How can this be achieved without
causing harm to the process itself?
The Food Standards Agency Bill will be published
shortly setting out proposals designed to restore consumer confidence
in the regulatory system. Much has already been done. For example
the advisory committees are now publishing minutes of their discussions,
making their annual reports more widely available (the ACNFP 1997
annual report was placed on the internet last week) and holding
meetings in public wherever possible. MAFF has also co-sponsored
an exhibition developed by the Science Museum to explain the issues
involved with GM foods.
Improved transparency can help allay concerns,
but consideration also needs to be given to what the underlying
reasons for concern are and, as mentioned in the reply to question
9, steps are about to be taken to examine this in more detail.
14. For trial releases, will anything be
lost, or what might be lost, in the move from horizontal (GMO)
to vertical (product) legislation? Expertise? Would this be appropriate
for commercial release too?
Does the application of the criteria for
safety of novel foods to field trials where environmental risks
are likely to be the major problem diminish trust in the risk
How is the environmental safety of novel
foods that contain viable modified organisms assured?
This was to a large extent addressed in the
oral evidence in response to the question on the revision of 90/220/EEC.
A key concern held by the Government is the
proposal to remove from the scope of the directive those products
under development which are covered by Community legislation which
provides for a specific environmental risk assessment similar
to that in this directive. The Government is concerned that this
could have the result of environmental effects not being taken
adequately into account because of the need to weigh them against
other considerations addressed under product legislation. The
Commission's proposal does not include any role for the 90/220
competent authorities in the assessment and decision-making for
GMO products under development; the competent authorities' expertise
on environmental risk assessments for the deliberate release of
GMOs might therefore not be drawn upon. This would not encourage
public confidence in the regulatory regime. Further, the proposal
would not be helpful for those wishing to conduct research releases
because it would add to the complexity of gaining a consent: one
such release might require several approvals, and this could also
result in a longer time than the current maximum 90 days before
all proposals were granted.
As regards commercial releases, the Commission
has strongly advocated a "one door, one key" policy,
whereby there would be only a single regulatory entry point for
access to the Community market. Only three Community instruments
have been adopted so far which remove GMO products from the scope
of 90/220: the medicinal products regulation (2309/93), Commission
Directive 94/40/EC amending Council Directive 87/153/EEC fixing
guidelines in the assessment of additives in animal nutrition
and the novel foods regulation (258/97); others, such as amendments
to the seeds directives and a novel seeds regulation, are under
negotiation or are planned. Each of these, in providing a derogation
from 90/220, requires that necessary consultations be held with
the bodies set up by the Community or the Member States in accordance
with Directive 90/220. However, none of the instruments sets out
procedures for the consultation or provides a mechanism to take
into account the overall view of the 90/220 competent authorities.
This has not presented difficulties up till now because only one
notification to market a product under these instruments has been
submitted. However, given the likely trend in the development
of GMO products, the Commission and the competent authorities
are seeking to introduce appropriate administrative mechanisms.
While the "one door, one key" policy
might be desirable in principle, the implications of the regulatory
requirements and the administrative practicalities need to be
considered. For example, if product based legislation is adopted
at the expense of horizontal regulation for research and development
trials crop plants may require approvals under more than one instrument,
depending on the final uses of the crop. For example, a particular
line of genetically modified wheat would be likely to require
separate approvals under the seeds, novel foods and animal feeds
Does the application of the criteria for
safety of novel foods to field trials where environmental risks
are likely to be the major problem diminish trust in the risk
assessment process? How is the environmental safety of novel foods
that contain viable modified organisms assured?
We understand this question to be associated
with the first of the two additional questions posed by the Lord
Reay (see question 26).
15. Regulatory transparency has to be balanced
with commercial confidentiality. This is of especial concern over
intellectual property and eco-terrorism. Is either the publication
of dossiers or the exact location of field trials unwise? Are
you considering any changes?
In submitting dossiers for application to release
or market genetically modified organisms, applicants can indicate
information which they consider to be commercial in confidence.
The extent of such information is subject to review by and agreement
of the Secretary of State before the application proceeds. The
GMO deliberate release regulations prevent information agreed
by the Secretary of State to be commercial in confidence from
being released or published. Applicants are required to inform
the Secretary of State once information is no longer commercial
Under the directive and the UK legislation,
the location of field trials may not be kept confidential and
this is part of the information required to be placed on the Public
Register. One of the purposes of making this information public
is to inform those in the neighbourhood of proposed release sites.
It is regrettable that this information has also been misused
recently by direct action protesters to locate and vandalise field
trials of genetically modified crops. These trials are necessary
in order to answer many of the questions that pressure groups
and others have raised. Ministers have condemned these attacks
but the scope for further action under the current legislation
is limited. It is the responsibility of consent holders to safeguard
their sites and they may involve the police to assist them where
The government is not, at present, considering
any changes in the current arrangements.
16. Have you identified any gaps in the current
regulatory process which you are keen to see filled?
The current legislation covering contained use,
deliberate release and marketing of products provides a comprehensive
package of controls to ensure protection of human health and the
environment. There are no obvious gaps. However as described in
the oral evidence in response to the question on animals, the
Government proposes to strengthen the controls on the contained
use of plants and animals by making additional provisions for
Concerns have been expressed that wider environmental
issues associated with the commercial introduction of some GM
crops may not be adequately covered. In practice, the environmental
risk assessments carried out for the GMO legislation taken together
with the pesticides legislation where appropriate should address
such issues and no distinction is made between the agricultural
and the natural environment. However the Government is reviewing
whether there are any other environmental aspects which are not
being addressed under the current regime.
From the administrative point of view the Advisory
committees have broad terms of reference and can also recommend
that specific issues are taken forward by Ministers. On the food
side the Food Advisory Committee had its terms of reference enlarged
last year to enable it to consider any food related issues not
considered by other committees.
17. Within the US and EC, conventional crops
are sometimes limited to particular geographic areas (or states)
due to geographic concerns (wheat and absence of weedy relatives/potatoes
and climate). Why might a GM crop be unsuited to growth in the
EC or vice versa? Could this be done for GM crops on more political
The Government is not aware of any instances
where, for climatic reasons, a GM crop would not be suited to
cultivation in the EC unless its non-GM counterpart was similarly
constrained. There may be situations where farmers may not need
to grow some disease resistant GM varieties if the disease is
not prevalent in a given location. The Government is also aware
of concerns associated with the cross pollination of GM herbicide
tolerant crops with weedy relatives. Following publication of
a discussion paper last year the Government will be making an
announcement on proposals for the management of GMHT crops shortly.
18. Refuges have been recommended as a way,
for example, to maintain insect populations and to slow down the
development of immunity to GMHT and GMPR crops. Should refuges
be statutory or voluntary?
One of the concerns expressed about widespread
commercialisation of insect resistant GM crops is that it may
encourage the development of resistance breaking insect populations.
In areas of the United States where Bt cotton and Bt maize are
grown widely, refuges of non-GM crops are employed to maintain
a "bank" of non-resistant insects in the population.
Population modelling and field work indicate that this works to
delay the emergence of widespread resistance.
Experience suggests that refuges are most effective
in warm climates where target insects undergo several generations
in one season. In temperate Northern Europe, including the UK,
they may have little value. The Government has not yet formed
a view as to whether such refuges are necessary nor whether they
should be voluntary or statutory. More research is required in
this area to evaluate the potential threat of resistant insects
and to formulate effective measures to prevent or delay the selection
of resistance. Although experience from managing resistance in
existing agricultural practice suggests that effective measures
can be found. This will help to identify the specific need for
and extent of further research. Based on this, guidelines for
best practice could be produced as they have been of other issues
by the farming industry's Supply Chain Initiative for Modified
Agricultural Crops (SCIMAC).
19. It has been put to us that the growing
of GM crops might be limited (voluntary or statutory) to particular
areas within Member States, either to protect particular biodiversity
or to assist segregation as value-added modifications are introduced.
What is your view on such zoning?
The Government has no legal powers to apply
additional conditions to marketing consents for GM crops. However,
as has been mentioned in reply to question 17 the Government will
be making an announcement on the management of GMHT crops shortly.
20. The best way to prevent a super weed
is by making plants male sterile. This would end the practice
of farmers saving up to 30 per cent of their seed. The same effect
could be enforced contactually. Is this a change the Government
would be concerned by?
We were told by the American Soya Bean Association
representatives that until the advent of the Bt Soya bean they
had kept upto of of the seed sown in each year, and only purchased
approximately . Their contracts do not now allow them to keep
any seed at all. The introduction of hybrid varieties, which cannot
be kept as the yield drops substantially after the first year,
or of male sterile seed would mean that farmers could not keep
seed effectively. Should this be a concern?
United Kingdom and European Union plant breeders'
rights legislation* specifically provides for farmers to save
seed of the main agricultural species which have historically
been farm saved in the EU (e.g., cereals, potatoes, oilseeds).
In addition, the recently adopted Directive on the Legal Protection
of Biotechnological Inventions contains a provision which states
that farmers can use farm saved seed containing a patented invention,
without this use constituting infringement of the patent. This
applies to the same extent and subject to the same conditions
as Community plant breeders' rights. These provisions aim to strike
a balance, which we would wish to encourage, between the use of
farm saved and certified seed.
We have no experience of the contracts which
American companies are said to use to control the use of farm
saved seed. The nature of the seeds market in the UK is such that
plant breeders do not normally enter into direct contracts with
individual farmers. Seeds merchants are licensed by plant breeders
to deal in protected varieties and it is the merchant who sells
seed to the farmer to produce a commercial crop.
The farm saved seed provisions do not extend
to seed saved from a crop grown from a hybrid variety, but a crop
resulting from such seed would have limited value. There are also
a range of varieties available to farmers. Hybrids are common
in the oilseeds sector, for example, but there are still plenty
of non-hybrid oilseed varieties for a farmer to select, which
can be farm saved.
* See the Plant Varieties Act 1997, s.9 and Council
Regulation 2100/94, Article 14.
21. How concerned is the Government by the
use of antibiotic resistant marker genes? Have you recommended
The presence of antibiotic resistance marker
genes in Genetically Modified Organisms released to the environment
has been considered by the Advisory Committee on Releases into
the Environment (ACRE). In particular, the committee has reviewed
the presence of antibiotic resistance genes in genetically modified
plants and examined the potential environmental safety issues,
including the possibility of gene transfer to soil microbes. ACRE
hav concluded that the risk to human health and the environment
from the current markers (mostly for kanamycin and ampicillin
resistance) is low. This is primarily because of the prevalence
of antibiotic resistance that already exists in the environment.
Any addition made to this resistance background that might result
from the release of GMOs will be negligible.
That said, ACRE is concerned that resistance
markers for antibiotics which have an important role in medicine
are not used in GMOs to be released. Further, the committee has
recommended that in principle, products which come to the market
should not contain material (including marker genes) which does
not contribute to the modification for which the product is being
marketed. This is not for safety reasons but for the sake of good
practice as the marker genes have no function in the final plants.
The Advisory Committee on Novel Foods and Processes
(ACNFP) has examined the concerns raised in connection with the
use of antibiotic resistant market genes in considerable detail
and has produced two reports. Copies of the ACNFP reports are
enclosed. [not printed]. The Committee's overall conclusion
was that the use of antibiotic resistance marker genes should
be considered on a case by case basis taking into account:
the clinical use of the antibiotic;
the likelihood of transfer into and
expression in gut micro organism; and
the toxicity of allergenicity of
the gene product.
The ACNFP also recommended that those developing
food GMOs should develop alternative markers or find ways of removing
those used. There is evidence that companies are starting to act
on this recommendation.
22. English Nature have based their call
for a moratorium on the fact that research is needed into the
effects of GM crops. What research has been commissioned and when
are results expected?
What is the impact on wildlife of GM crops?
Are you funding research in this area? If not, why not? If yes,
when are the results likely to be published?
The reduction in the volume of herbicide
that needs to be used is well known, and is arguably good for
the good for the soil and consumer, but what impact on biodiversity
has there been?
What is the impact on wildlife of GM crops?
The DETR has funded a programme of research
since 1987 into the issues and implications raised by the release
of GM crops into the environment. Results of research programmes
are published as Research Reports and are widely available from
the DETR publications sales centre. The scope of the published
projects relating to the possible impact of GM crops are summarised
Report no. 1.Genetically modified crops
and their wild relativesa UK perspectiveassessed
the likelihood of transgenes being transferred from genetically
modified crops to wild species growing in the UK. This included,
where relevant, establishment of the crops themselves as feral
Report no. 8. Gene flow in natural populations
of Brassica and Betaaddressed the issue of transfer
of modified genes between crops and wild relatives. Such information
is important in evaluating both the potential for the escape of
transgenes, and the environmental risk assessments of each release.
Report no.9. Selectable marker genes in genetically
modified organismsevaluated the potential hazards of
the use of selectable markers in plants, microorganisms and animals
intended for release into the environment.
Currently there are three ongoing research projects
that should provide additional information on the environmental
impact of growing GM crops. These projects are:
Environmental impact of insect resistance in
GM plants. Completion date December 1999.
Impact of multiple tolerance in GM plants. Completion
date December 1999.
Environmental impact of disease resistance in
GM plants. Completion date September 2000.
In addition to these three projects, another
project is planned to investigate the Environmental risks of
stress tolerance in GM plants. The aim of this is to provide
more information to help evaluate the risks of the release of
such plants. This project is planned to be completed in September
In 1990 MAFF started a programme of research
to look at the possible risks to the agricultural environment
from the release of genetically modified organisms. Over £3.5
million has been committed to the programme and, to date results
have not indicated any risks to the agricultural environment from
the release of GMOs. In 1997, new research on the risks to the
agricultural environment from the release of herbicide tolerant
crops was commissioned with a total budget of over £500,000.
A list of some of the work covered in the herbicide tolerance
projects is given in paragraph 13 of the original briefing submitted
to the Committee.
The impact on wildlife of the release of GM
plants has, thus far, been negligible. The releases conducted
to date have been for experimental purposes and are only approved
after a rigorous risk assessment has indicated they will be safe.
Over 300 field trials of GM crops have been carried out in the
UK and the post trial monitoring has demonstrated that none of
these has resulted in harm to the environment.
The wider implications of the commercialisation
of GM crops for wildlife is the subject of current debate, particularly
the possible reduction in farmland biodiversity that changes in
agricultural practice may cause. The results from DETR funded
research projects provide valuable information on a number of
possible environmental issues that may arise from growing GM crops.
None of the results obtained so far, either from completed projects
or those ongoing, give cause to believe that the GM crops studied
will necessarily be any more damaging to the environment than
conventional agricultural practice.
The Government is working with the Advisory
Committee on Releases into the Environment and Conservation Bodies,
including English Nature and RSPB, to address their concerns about
impact on wildlife and find a way forward. This consultation is
focusing on the wider implications of GM crops and their possible
effect on wildlife. This will highlight areas in which further
research is needed and help to formulate the most appropriate
questions to be addressed.
23. In the event of something going wrong
with a GM crop, who would be responsible? Is this an issue that
concerns you? Would this be different if it were a food or feed
Civil liability for damage caused by a genetically
modified organism is governed by the Common Law as developed by
the courts. On the basis of Common Law principles, the firm holding
the marketing consent for the genetically modified crop may be
liable in law for any damages arising from ill effects attributed
to the crop. Depending on the facts of the case the statutory
regime for product liability may also be relevant.
The issue of environmental liability is an important
one and the principal that those who damage the environment should
pay for remedying the damage caused is one that the Government
The Government understands that the European
Commission intends to issue a White Paper on liability for environmental
damage. This may include the question of damage caused by genetically
modified organisms. The Government will study the detail of the
Commission's proposals before reaching any conclusions on this
The Government is of the view that in the event
of something going wrong with a GM crop the company that holds
the marketing consent for the crop would be liable. Indeed an
applicant is already required to report any information which
might affect the original risk assessment.
The Government supports in principle the proposal
in the European Commission Green Paper on Food Law to extend product
liability to primary agricultural produce and agrees that the
extension of product liability to primary agricultural produce
should be considered afresh, but the full implications must be
explored before any final decisions are taken. It is important
that the liability for producers is matched by the reasonable
defence of due diligence.
24. Is risk assessment for novel foods an
EC process or for Member States?
The risk assessment for novel foods is initially
undertaken at Member State level. An application is submitted
to the Member State where a product is intended to be marketed
first. That Member State has 90 days to provide an initial safety
assessment. This initial assessment is then considered by all
Member States within 60 days. If Member States raise objections
or identify the need for a more detailed assessment the application
is considered further under a centralised authorisation procedure.
Final approval is therefore a matter for the Community as a whole.
The European Commission produced guidelines on the safety assessment
of novel foods to accompany the Novel Foods Regulation 258/97.
A copy of the Commission guidelines and the electronic version
developed in the UK are enclosed. [not printed].
IMPORTED GM FOOD
25. The regulations at present are causing
a stockpile of food, predominantly from the US. What approvals
do imports require? Do they require an environmental assessment?
Is this necessary where they are only to be imported for food
use? How may the system be speeded up without any extra risk to
the consumer or the environment?
Where a GMO is intended to import solely for
processing into food products approval is only required under
the EC Novel Foods Regulation (258/97). If the crop is to be grown
in Europe approval is also required under Directive 90/220/EEC.
Under both sets of legislation an environmental risk assessment
is required for viable material, e.g., grain, which could be grown
in Europe. If the crop is only imported for food use an environmental
risk assessment is still required to assess the impact of accidental
spillage during transport. The Government is seeking to speed
up the approval process without compromising safety. The Commission's
proposed revisions to Directive 90/220 should help in this respect.
In addition the Government is encouraging companies to submit
applications in the US and EU in parallel rather than in the sequential
way that has so far predominated and lead to many of the stockpiling
problems referred to.
Additional questions posed by Lord Reay
26. For commercial release, the directive
exempts GMOs for which product legislation exists. There is a
novel foods regulation. Would an application to grow and to use
for food, for example a frost-resistant wheat, be subject to both
90/220 and the novel food regulation?
Directive 90/220 and the Novel Foods Regulation
operate in tandem: Consent would be required under 90/220 to sow,
cultivate and harvest a genetically modified crop, and, at present,
to use it as an animal feedingstuff. Under the Novel Food Regulation,
consent would be required in order to market novel foods consisting
of the genetically modified crop plant or derived from it. Both
instruments require an assessment of the risks to the environment
and to human health. However, while the scope of the environmental
risk assessment under 90/220 must address all the risks associated
with all the release activities, that is, sowing and cultivation,
etc., the assessment under the Novel Foods Regulation needs only
to cover any aspects that would involve release to the environment
of the novel food itself. Usually there will be no such release,
or a very limited release. Therefore the scope of the risk assessment
is tailored in each case to the activities governed by the respective
instrument. There can therefore be trust that together, the instruments
provide for a comprehensive assessment of the risk.
27. The Commission has proposed ending the
use of PVC. If a plastic duck is made from a plastic produced
in a GM plant and contains the gene product, would it need to
be labelled as GM? Would it be subject to monitoring and potential
seven year recall?
Under current EC legislation the seeds from
such GM plants would have to be labelled, however the plastic
duck made from them would not, as the only non-viable products
that have to be labelled as genetically modified are those food
products which contain genetically modified material. The plastic
derived from the GM plant would not be covered by this legislation,
or by Directive 90/220/EEC. The plants growing the plastic would
be subject to the proposed monitoring and potential seven year
recall but not the ducks themselves.