Memorandum submitted by the Department
for Environment, Food and Rural Affairs (D3)
POSSIBLE APPROVAL FOR COMMERCIAL GM GROPS
IN THE UK: STEPS IN THE PROCESS
INTRODUCTION
1. The only GM crops in line for possible
commercial growing in the UK are those in the Farm Scale Evaluation
(FSE) trials. These involve three spring-sown crops (beet, maize
and spring oilseed rape) and one autumn-sown crop (winter oilseed
rape). These are all herbicide-tolerant varieties.
REGULATORY APPROVALS
2. In effect, several separate regulatory
approvals are needed before a GM herbicide-tolerant crop can go
into commercial production. Looking at each of these in turn:
(a) EU Directive on GMOs
3. This is the specific legislation that
provides for GMOs to be approved for release after an assessment
of the risks to human health and the environment. There are two
types of release approval—for research purposes and for
commercial marketing. The FSE beet and oilseed rape have research
consents and are in the blocked EU pipeline for marketing approval.
We do not know when the marketing decisions for these crops will
be taken. The FSE maize ("T25") already has a marketing
consent for cultivation and for use as an animal feed.
(b) Seeds legislation
4. A new agricultural crop variety, whether
GM or non-GM, cannot be marketed until it has been added to the
National List of plant varieties or the EU Common Catalogue (a
compendium of Member States' National Lists). Addition to the
National List is dependent on satisfactory completion of a minimum
two years of listing trials, to establish that the variety is
Distinct, Uniform and Stable, and that it has a Value for Cultivation
and Use.
5. A variety of the T25 maize in the FSE
trials, "Chardon LL", is proposed for addition to the
UK National List. This is subject to a public hearing as provided
for in the legislation, and it is not clear when Chardon might
complete the UK National List process. Another T25 variety, "Sheridan",
has completed listing trials but has yet to be formally proposed
for addition to the UK List. Ministers will be invited to make
a decision on Sheridan once all of the arguments on GM safety
made at the Chardon hearing have been considered by the Government's
independent GM advisory committees.
6. Chardon is already on the Dutch National
List as a result of which it could be added to the EU Common Catalogue
at any time, as could a number of other GM varieties (unrelated
to the FSE crops) on the National Lists of other Member States.
If this happens the varieties in question will then be cleared
under seeds legislation for marketing throughout the EU.
7. Varieties of the FSE oilseed rape and
beet crops have entered the UK National List system but are not
so far advanced as the T25 Chardon maize. Most have have completed
the required trials but cannot be formally proposed for addition
to the National List until they have marketing approval under
the GMO release Directive. Again, there is no firm estimate for
when these varieties might complete the seeds approval process.
(c) Pesticides legislation
8. For the growing of the FSE crops to be
commercially viable they will have to be used with the herbicide
to which they are tolerant. The commercial use of herbicides requires
approval under pesticides legislation. The companies concerned
(Aventis and Monsanto) have yet to apply for the herbicide approvals
relevant to the FSE crops and the timing of the possible approvals
is uncertain.
(d) EU Novel Foods Regulations
9. In addition to clearance of the crop
itself, any foods obtained from a GM crop have to be approved
under the EU Novel Foods Regulations. The Foods Standards Agency
is the UK competent authority for this legislation. Food ingredients
produced from T25 maize are already cleared for use (its main
intended use is as an animal feed), as is the oil that would be
processed from the GM oilseed rape in the FSE trials.
THE FSE RESULTS
10. The results of the FSE trials for the
spring-sown crops are expected to be published in a peer-reviewed
scientific journal in the summer of 2003. For the winter oilseed
rape crop the results are expected to be published in 2004. The
results will be considered crop-by-crop by the Advisory Committee
on Releases to the Environment and the Advisory Committee on Pesticides.
The Government will then take a view based on the committees'
advice and this will feed into appropriate regulatory decisions.
For example, if the results were to show that the GM crop herbicide-management
has an adverse environmental impact, the Government would have
to take that into account. It could take action under the GMO
Directive to restrict the existing marketing approval (in the
case of T25 maize) or would not support the outstanding applications
for marketing approval for cultivation of the beet and oilseed
rape. If the conclusion is that the FSE results do not demonstrate
an adverse effect on the environment then the Government would
lack the basis for such action. If a GM crop variety were to lose
its marketing approval under the GMO Directive then it would also
lose any marketing clearance it has under the seeds legislation.
27 May 2002
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