Memorandum submitted by the Department
for Environment, Food and Rural Affairs
GM GOVERNMENT DECISION
EXECUTIVE SUMMARY
1. The Government set out its approach to
GM technology, including its use in crops, in a policy statement
on 9 March 2004. Each application will be considered on a case-by-case
basis, including an assessment of any potential risks to human
health and the environment. Applying this approach to the GM crops
in our Farm-Scale Evaluations (FSEs), we concluded that the UK
should oppose the commercial cultivation of the relevant varieties
of GM beet and oilseed rape using the management regime tested
in the FSEs, but that we should agree in principle to the commercial
cultivation of GM herbicide-tolerant maize, subject to certain
conditions. Bayer CropScience has since announced that it no longer
intends to market the relevant GM maize for commercial cultivation
in the EU. Nevertheless we intend to press ahead with developing
measures to facilitate the coexistence of GM and non-GM crops
and to address related liability issues. We plan to consult stakeholders
shortly with a view to having coexistence measures in place by
spring 2005. We look forward to the results of the EFRA Committee's
inquiry as a contribution to this work.
BACKGROUND
2. The Government's recent policy statement
on GM was the culmination of a long and painstaking process. In
response to concerns which had been raised about GM crops, we
commissioned the biggest programme of farm-scale trials anywhere
in the world, as well as a GM "dialogue" comprising
a public debate, science review and a costs and benefits study.
We also received a report on coexistence and liability from our
strategic advisory body, the Agriculture and Environment Biotechnology
Commission (AEBC). In deciding our policy we gave full consideration
to all the available evidence.
3. We concluded that case-by-case regulation
of GM crops remains the right approach. We continue to take public
concern very seriously and we recognise the need to address people's
legitimate anxieties about GM crops. We have published a detailed
written response to the GM dialogue[5]which
explains how we are seeking to address the concerns which have
been raised. Our top priority is to protect human health and the
environment, and GM crops will continue to be strictly regulated
in accordance with the precautionary principle. We are also committed
to providing choice for consumers through mandatory labelling,
and for farmers by putting in place measures to facilitate the
coexistence of GM and non-GM crops.
4. The results of the Farm-Scale Evaluations
of three spring-sown GM herbicide-tolerant (GMHT) crops underline
the importance of a case-by-case approach. Broadly speaking, the
results suggested that growing GMHT beet and oilseed rape would
be worse for biodiversity than growing conventional beet and oilseed
rape, whereas growing GMHT maize was better for biodiversity than
conventional maize.
5. On the basis of the FSE results we concluded
that:
— the UK should oppose the commercial
cultivation of the relevant varieties of GM beet and oilseed rape
in the European Union using the management regime tested in the
Farm-Scale Evaluations;
— we should agree in principle to the
commercial cultivation of GM herbicide-tolerant maize, but only
subject to two further important conditions:
— first, that restrictions should be
imposed on the existing EU marketing consent, which expires in
October 2006, so that this maize could only be grown and managed
as in the trials, or under such conditions as would not result
in adverse effect on the environment.
— and second, in response to concerns
which have been raised about the phase-out of atrazine in the
European Union, that the consent holders should be required to
carry out further scientific analysis to monitor changes in herbicide
use on conventional maize and to submit new evidence if they sought
to renew the existing EU marketing consent in 2006.
6. We made it clear that before commercial
cultivation of GM maize could proceed, separate approval would
also be required under seeds legislation, and also under pesticides
legislation for the associated herbicide use. Furthermore the
relevant variety, Chardon LL, would not be added to the UK National
List of seeds until the necessary amendments to the EU marketing
consent were in place. At the time of the statement we anticipated
that Chardon LL would not secure all the approvals required for
commercial cultivation to take place before spring 2005 at the
earliest.
7. On 31 March Bayer CropScience, the company
which holds the existing EU marketing consent for the GM maize
tested in the FSEs, announced that it had decided to withdraw
its application to add Chardon LL to the UK National List of seeds.
Notwithstanding Bayer's decision, we plan to press ahead with
measures to facilitate the coexistence of GM and non-GM crops
and to address related liability issues, to ensure that a coexistence
framework is in place in the event that any GM crops are approved
for commercial cultivation in future.
8. We have indicated that we are minded
to proceed on the basis that:
— there should be a closely monitored
introductory period, following which we will review the effectiveness
of any arrangements;
— that GM farmers should bear the main
responsibility for implementing measures to minimise GM presence
in neighbouring non-GM crops;
— that these measures should be based
on the EU's 0.9% labelling threshold and should have statutory
backing;
— we will explore further with stakeholders
whether a lower threshold might be feasible for organic crops;
— we will consult stakeholders on options
for providing compensation to non-GM farmers who suffer financial
loss through no fault of their own as a result of GM presence
in their crops;
— that any compensation scheme would
need to be funded by the GM sector itself, rather than by Government
or producers of non-GM crops;
— we will provide guidance to those
farmers wishing to establish voluntary GM-free zones.
9. We are currently drafting a consultation
document which we plan to publish shortly. Our aim remains to
have measures in place by spring 2005, even though we do not now
anticipate that there will be any commercial cultivation of GM
crops in the UK in the immediate future.
10. The following sections address the specific
issues which the Committee has indicated that it intends to consider.
SEPARATION DISTANCES
11. We envisage that farmers growing GM
crops will be required to apply separation distances to minimise
cross-pollination with neighbouring non-GM crops. We agree with
the AEBC's recommendation that GM farmers should bear the main
responsibility for implementing measures designed to keep GM presence
in non-GM crops below the EU's 0.9% labelling threshold. We will
consult on whether a lower threshold might be applied in the case
of organic crops, and if so whether the GM farmer or the organic
farmer should be responsible for applying the separation distance.
12. Separation distances will need to be
determined on a crop-by-crop basis. For the purpose of the Farm
Scale Evaluation (FSE) trials, separation distances allied to
a notification requirement were applied under the terms of a code
of practice drawn up by the farming and industry group SCIMAC
(Supply Chain Initiative on Modified Agricultural Crops). Under
the SCIMAC guidelines the FSE growers were expected to notify
their neighbours of their intention to sow a GM crop if their
neighbours' land fell within a specified distance, the idea being
that the farmers should then discuss their respective cropping
plans as necessary. The separation distances which were applied
under the SCIMAC code are shown in the table below. (Note: A nominal
distance was included for beet crops because special factors apply
which mean that cross-pollination should not be a serious issue.
See further comments on beet in paragraph 14 below.)
SEPARATION DISTANCES IN SCIMAC CODE
| Crop | Seed crops
(same species)
| Organic crops
(same species) |
Other non-GM crops
(same species) |
Oilseed rape | 200m
| 200m | Conventional varieties and restored
hybrids: 50m
Varietal associations and partially restored
hybrids: 100m
|
| Sugar and fodder beet | 600m
| 600m | 6m |
| Maize | 200m | 200m
| Sweetcorn: 200m
Forage maize: 80m
|
| |
| |
13. In 2000 the National Institute of Agricultural Botany
(NIAB) completed a Defra-commissioned review of the separation
distances required to limit cross-pollination between maize and
oilseed rape crops to 0.1%, 0.5% and 1% on a whole-field basis.
This recommended the following distances:
RECOMMENDED SEPARATION DISTANCES FROM NIAB REVIEW
| Distances needed for specified cross-pollination threshold:
1.0%
0.5%
|
| 0.1% | |
| |
Oilseed rape
Conventional varieties
| 1.5m | 10m | 100m
|
| Varietal associations | 100m
| (insufficient data) | (insufficient data)
|
Maize
Grain (sweetcorn) |
130m | 200m | 420m
|
| Forage maize | 80m | 130m
| 290m |
| |
| |
14. The NIAB review did not make recommendations in relation
to beet crops because cross-pollination does not affect the composition
of the utilised plant tissues (only vegetative parts of the plant
are harvested rather than seeds or fruits). This means that if
a GM beet cross-pollinates a non-GM beet plant the root of the
latter will not have any GM content (DNA or protein). Moreover,
beet crops are normally harvested before they flower and farmers
usually control any "bolting" plants that flower prematurely.
15. A Defra-funded research report[6]
on gene flow from the GM maize crops in the FSEs has provided
further data relevant to the consideration of separation distances.
A parallel report on gene flow from the FSE oilseed rape crops
is in preparation and will be published in due course. We have
asked NIAB to review the separation distances in their 2000 report
in the light of the new data provided by the FSE gene flow studies
and any other available data.
LIABILITY ISSUES
16. When considering liability issues it is important
to distinguish between liability for any economic loss which might
be suffered by non-GM farmers as a result of GM presence in their
crops, and liability for any environmental damage which may be
caused by GM crops and other genetically modified organisms (GMOs).
Both issues are discussed below.
LIABILITY FOR
ECONOMIC LOSS
17. If broadly effective measures are in place to manage
the co-existence of GM and non-GM crops, then in principle the
instances where non-GM growers might suffer an economic loss should
be relatively infrequent. However we recognise that there may
still be cases where non-GM farmers could suffer a loss through
no fault of their own because GM presence in their produce exceeds
statutory thresholds. There may be an economic loss if the value
of produce labelled as containing GM is less than the value of
produce which does not contain GM.
18. Non-GM farmers could seek to recover any loss through
the civil courts under the common law of negligence or nuisance.
There is no direct precedent for such a claim, although there
are analogous cases that may be relied upon. As a result it cannot
be said with any certainty whether a common law claim for economic
loss would succeed. In any event we agree with the AEBC that it
would be preferable to avoid a situation where farmers are forced
to seek redress through the courts.
19. We have therefore accepted the AEBC's recommendation
that there should be special arrangements for compensating farmers
who suffer a financial loss through no fault of their own. We
have said that we will consult stakeholders on options for providing
compensation, while making clear that any compensation scheme
would need to be funded by the GM industry itself, rather than
by Government or producers of non-GM crops.
20. There are a number of issues which still need to
be resolved and on which we plan to consult stakeholders. These
include:
— How to ensure that any compensation scheme is
fair and is not open to abuse.
— How liability should be established ie whether
liability should be fault-based or whether strict liability should
apply.
— Whether any compensation scheme should be voluntary
or compulsory.
— Whether compensation should be payable only in
relation to the 0.9% threshold or also in relation to a lower
threshold for organic produce.
ENVIRONMENTAL LIABILITY
21. The AEBC also made a number of recommendations in
respect of liability for any environmental damage which may be
caused by GM crops or other GMOs. The Secretary of State already
has powers under the Environmental Protection Act 1990 to require
companies to take remedial action if they have committed a criminal
offence. The EU has recently adopted a Directive on Environmental
Liability, which covers the release and contained use of GMOs.
However the scope of the Directive is limited, including to serious
damage to European protected species and natural habitats. Under
the Directive the relevant biotechnology company may be held liable
for damage caused by one of its products.
22. The AEBC recommended that the Government should use
the general approach of the EC Environmental Liability Directive
in developing the UK's liability regime for any damage caused
by the release of GMOs into the environment. In addition it recommended
that the Environmental Protection Act 1990 should be amended to
allow environmental remediation to be ordered by the regulatory
authority without the need to first secure a conviction for an
offence.
23. We have not yet reached any firm conclusions with
regard to the AEBC's recommendations on environmental liability,
though we accept that the issue needs to be addressed in advance
of any commercial cultivation of GM crops. We will continue to
give consideration to the AEBC's recommendations and will set
out our conclusions in due course.
VOLUNTARY GM-FREE
ZONES
24. Under current EU legislation once a GM crop has been
approved it can be grown commercially anywhere in the EU. Directive
2001/18/EC on the deliberate release of GMOs into the environment
provides that member states may not prohibit, restrict or impede
the placing on the market of GMOs that comply with the requirements
of the Directive. However, conditions imposed with respect to
risks to the environment or human health as part of the marketing
consent under the Directive could deal with certain geographic
areas differently. If such conditions were to be imposed, this
could have the effect of limiting the marketing of a GMO in some
geographic areas. In practice if a GM crop were considered to
pose a risk to a particular geographical area of the UK then it
would probably pose a similar risk to other areas in the EU, and
this would make it very unlikely that EU member states would approve
the crop for marketing at all.
25. The European Commission has made it clear that mandatory
"GM-free" zones would not be consistent with the Directive,
if the effect was to deprive individual farmers of the opportunity
to grow GM crops which have been approved for commercial cultivation
in the EU. However the Commission has indicated that voluntary
GM-free zones are permissible, whereby farmers in a particular
area might enter into a voluntary agreement not to grow GM crops.
The Government is therefore proposing to provide guidance to farmers
wishing to establish such voluntary GM-free zones. We envisage
that guidance will set out the legal framework and address practical
issues which farmers may wish to consider. The final content of
any guidance will be determined in the light of consultation with
stakeholders.
26. In offering to provide guidance the Government's
aim is purely to assist those farmers who might be interested
in establishing voluntary "GM-free" zones. The Government
is not advocating the establishment of such zones, nor does it
regard them as necessary. The coexistence measures which we plan
to put in place are intended to provide a reasonable balance between
the economic interests of GM and non-GM farmers. Nevertheless
we accept that some farmers may still want to explore the option
of setting up voluntary "GM-free" zones.
What Changes in legislation will be required to allow GM crops
to be grown?
27. Directive 2001/18/EC already provides for GM crops
to be considered for commercial cultivation on a case-by-case
basis and, once they have the necessary approval, to be marketed
anywhere in the EU. The EU's new GM Food and Feed Regulation (1829/2003/EC),
which came fully into effect on 18 April this year, provides a
single approvals procedure for GM food and feed products to the
same standards as Directive 2001/18/EC. Before any crop can be
grown commercially separate approvals will still be required under
seeds legislation and, if appropriate, under pesticides legislation
for any associated herbicide use.
28. Directive 2001/18/EC was amended in 2003 to include
a provision which allows member states to implement national coexistence
measures. The UK Government and the Devolved Administrations have
made it clear that we intend to make use of this provision to
put in place coexistence measures in the UK. We currently envisage
that regulations will be made under section 2(2) of the European
Communities Act 1972 to deliver coexistence measures, subject
to final decisions on the detailed measures in the light of consultation
with stakeholders. We will continue to work closely with the Devolved
Administrations with a view to maintaining a co-ordinated approach,
though it is possible that the DAs may decide to put in place
their own national arrangements.
What will be the scope and scale of the 2006 re-licensing procedures?
29. At the time of writing no GMOs have been approved
under Directive 2001/18/EC, though a number of consents issued
under the predecessor Directive 90/220/EC will remain valid until
2006. The procedures for renewal of these existing consents are
set out in Article 17 of Directive 2001/18/EC.
30. Applications for renewal must be submitted before
17 October 2006 to the member state which issued the consent.
The consent holder must submit:
— a report on the results of any monitoring carried
out in line with the consent conditions;
— any other new information which has become available
with regard to risks to human health and/or the environment; and
— as appropriate, a proposal for amending the consent,
including any future monitoring.
31. Member states must then reach a collective decision
on whether to renew the consent, on the basis of an assessment
by the lead member state, within the timescales laid down in the
Directive.
Department for Environment, Food and Rural Affairs
April 2004
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