CHAPTER THREE: THE APPROVAL PROCESS
Sources of Scientific and Technical Data
58. Applications for approving GMOs for food use
or for environmental release are supported by the applicant's
own data and risk analyses. Some witnesses argued that "committees
rely far too heavily on the biotech industry's own data and risk
assessments, many of which have not been independently reviewed".
Other witnesses rejected such criticisms. Professor Bainbridge
pointed out that the majority of members on scientific advisory
committees were well experienced in the assessment of scientific
data and peer review.
Indeed it is the advisory committees themselves that are performing
the independent review. Moreover, ACRE and ACNFP do not rely solely
on the information supplied by the applicants but also draw on
other sources and almost always demand the production of data
from applicants in addition to that submitted with the original
application. And as Professor Bainbridge also reminded us it is
very important to realise that the science we are looking at is
science that has been subject to the normal processes of science,
that is, peer review.
Novartis argues that the risk assessments produced for the regulators
are very expensive and require specialist expertise so it is appropriate
that the regulators act as examiners for the assessments rather
than attempt to undertake the evaluations themselves.
We do not believe that it would be either appropriate or practical
for ACRE and ACNFP to do anything other than use an applicant's
own data in their assessments. We agree with Novartis that "regulation
by review of companies' risk assessments works well in pharmaceutical
and pesticide regulation" and this is accepted by the public.
Where inadequate information is provided, it is acceptable that
further research is commissioned and paid for by the applicant.
59. Some witnesses suggested that scientific advisory
committees should be able to commission underpinning research
where there are areas of uncertainty that need resolving.
ACNFP already has the ability to recommend areas for MAFF research,
as ACRE does for DETR research.
While we accept that it is important that both ACRE and ACNFP
should be able to call for research to be undertaken, we caution
against giving them their own specific research budgets. Budget
allocation would put a huge administrative responsibility on the
committees and their secretariats but the strategic research needs
of scientific advisory committees must be considered. We recommend
that when ACNFP moves under the management of the Food Standards
Agency, an appropriate part of MAFF's research budget be transferred
to the Agency. Formal links should be established between DETR,
the Foods Standards Agency, the Foresight programme and Research
Councils so that ACNFP's and ACRE's longer-term basic research
requirements can be considered. We recommend that the Minister
for Science plays a strong role in ensuring proper coordination
between the various research funding agencies and Departmental
research programmes in this area.
60. Part of the procedure for assessing novel foods
rests on establishing 'substantial equivalence' a methodology
developed by the WHO and the OECD and used internationally as
a basis for performing risk assessments on novel foods.
If a novel food is judged to be substantially equivalent to a
conventional counterpart, then it can be considered to be as safe
as the conventional counterpart. Establishing substantial equivalence
is a complex process involving measurements of the constituents
of the GM food and comparing them with a conventional counterpart.
If a GM food is found to be substantially equivalent to its conventional
counterpart, it will normally be approved. Where a food is deemed
not to be substantially equivalent, a more detailed analysis is
61. MAFF told us that using this methodology overcomes
the "practical difficulties that are associated with trying
to test novel foods using traditional animal studies where the
nutritional balance of the animals' diet can often be adversely
However substantial equivalence has its critics. The Consumers'
Association argued that the approach used to establish substantial
equivalence "fails to acknowledge the potential for unintended
and unpredictable side effects".
Professor James of the Rowett Research Institute pointed out that
establishing substantial equivalence "depends on correctly
specifying and measuring those elements of concern" which
may not always be possible.
He also argued that, while there were few doubts that the principle
of substantial equivalence was an effective tool for current assessment,
"given the extremely large number of GMOs currently under
trial, we consider that there is a need to develop new screening
strategies which take account of current scientific knowledge
and a need ... to have greater assurances on the safety of GMOs".
Professor Bainbridge pointed out that ACNFP, rather than the applicant,
had discretion over whether to proceed on the basis of substantial
equivalence or to conduct a far more detailed analysis.
We are not convinced that present GM food safety assessment protocols
are flawed. Nevertheless any robust and sustainable scientific
advisory system must be prepared to challenge some of its basic
tools, especially when doubt is cast on the validity of those
assumptions by others. Therefore we recommend that the Government
works with its European partners to investigate new approaches
to the safety assessment of novel foods and commission appropriate
The Case by Case Approach
62. ACRE and ACNFP consider each application submitted
to them on its individual merits. This approach has led some witnesses
to suggest that there is a lack of analysis of the overall, cumulative
impact of genetic modification on agriculture, the environment
and of the general effects of GMOs in the long term. Professor
Burke told us that "the case by case approach has proved
inadequate as the number of approvals have grown ... the cumulative
implications of successive decisions have not been considered".
The British Medical Association told us that the "case by
case approach to GMO regulation ignores the cumulative effects
Both the Royal Society and the Royal Commission on Environmental
Pollution have also drawn attention to its weaknesses.
ACRE'S BIODIVERSITY REMIT
63. Until last year, ACRE's role primarily involved
assessing the direct impact of releasing a GMO into the environment
on a number of selected species and the possibility of escaping
genes. Indirect effects, such as the impact of the introduction
of a GM variety on the overall volume of chemicals used during
the growing season did not form part of ACRE's assessments. ACRE's
remit has since been widened to include consideration of the effects
on biodiversity of GM crops, especially when grown commercially.
This change has been widely welcomed.
ACRE has established a working group to explore the scope of the
issues and we welcome the fact that English Nature and the RSPB
have been participating in this process. We welcome the Government's
decision to extend ACRE's remit to include consideration of the
cumulative impact of GM crops on biodiversity.
64. The introduction and management of GM crops must
also be considered in the context of wider concerns regarding
the environmental impacts of today's intensive agriculture. These
indirect effects are currently not within the scope of risk assessments
as required under the Deliberate Release to the Environment of
Genetically Modified Organisms Directive 90/220, and consequently
ACRE's extended remit may not be matched community wide. Amendments
to this directive are currently under negotiation.
Mr Meacher told the House of Lords European Communities Committee
that "the UK is seeking to make sure that the scope of the
Directive and of the environmental risk assessment is well defined
and broad enough to cover indirect as well as direct effects of
We welcome this. We believe that Directive 90/220 should be
amended so that the cumulative effects of GMOs and their management
on the environment and on biodiversity are assessed as part of
all approvals for deliberate release.
The Need for More Research
ON ENVIRONMENTAL IMPLICATIONS
65. The need for research to underpin Government
policy and decision making on GMOs goes further than the need
to meet the specific requirements of advisory committees. Several
witnesses commented on the limited amount of scientific results
on which to base assessments of the environmental hazards presented
by releasing GMOs. The Consumers' Association told us that there
is lack of independent research into "the long-term implications
of the introduction of GM crops and foods".
English Nature supplied us with an extensive list of the research
projects they believe need to undertaken, a number of which they
identified as being of high priority.
Mr Meacher argued that the Government already had a broad portfolio
of research projects in this area and that the budget for such
research had been increased from about £900,000 in the current
year to around £1.2 million over the next two to three years.
We welcome the increase in publicly-funded research into the
environmental impacts of GMOs. However, the Government's research
programme should also take into account the concerns of organisations
such as English Nature.
It is disappointing that this is not yet occurring and Mr Meacher
has undertaken to address this point.
A MORATORIUM ON COMMERCIAL PLANTING?
66. There have been calls for a moratorium on the
planting of commercial crops although English Nature told us that
"we have not pressed specifically for any kind of particular
moratorium but what we have said is we need to go more slowly
and need much more evidence on some areas ... we are saying that
there should be no commercial planting until there is enough evidence
to make a better assessment than we can make at the moment".
They also told us that they thought this would be around 2003.
Other witnesses, such as the RSPB and the Farmers' Union of Wales,
supported English Nature's stance, while others have variously
called for a three or five year moratorium on commercial planting.
67. Professor Beringer told us that "the field
releases that have been done have been so smallabout half
the size of this room ...that you can make almost no meaningful
ecological response from them".
The Government has announced three farm-scale trials of GM crops
to investigate environmental impacts which will run for the next
four years but it has rejected calls for a moratorium on commercial
Mr Meacher assured us that commercial planting of GM crops would
not be permitted until the Government was satisfied that it had
enough information to make a sound judgement, but suggested that
it was not possible to predict with any degree of accuracy when
this might be.
Yet in February this year the Government stated that "limited
and monitored commercial planting of GM crops may start in the
UK next year" provided that all regulatory hurdles had been
We do not know what advice the Government might have received
that led them to this conclusion. We accept it is difficult to
determine precisely when farm-scale trials might result in adequate
information, or whether further trials may be required, to allow
the Government to make well-informed decisions on the commercial
planting of GM crops. We also accept that the only way in which
the Government can gather such data is to perform further farm-scale
trials in accordance with EU Directive 90/220. It is precisely
because of the uncertainty over the length of time that will be
required to obtain sufficient data from the farm-scale trials
that we believe that calls for a fixed term moratorium are inappropriate.
We are, however, convinced that it is impossible for the farm-scale
trials to have provided adequate information after only one year.
In practice it seems that there is already a de facto
moratorium on commercial planting in place. GM crops may not be
released into the environment without the necessary consent from
the Government and no such consents have yet been issued for commercial
growing. Government must make it absolutely clear that commercial
growing will not be permitted without adequate information from
ON THE IMPLICATIONS OF CONSUMPTION OF FOOD FROM GM
68. Some witnesses raised similar concerns regarding
the paucity of knowledge of the long-term impact of eating GM
food. For instance, the Royal Society of Edinburgh stated that
"while the thoroughness and quality of scientific advice
on this issue is good, GM foods come almost entirely into a category
where scientific evidence is ... partial and constantly under
The Health Promotion Agency for Northern Ireland, pointing out
that the technology which allows the genetic modification of food
ingredients was relatively young, argued that "the potential
long-term effects on human health ... should be examined".
No foods in the human diet can be said with certainty to be risk-free
there are many conventional foods available which have
well-documented health risks. Nevertheless, it is foolhardy to
introduce any new technology, in any sphere, without adequate
follow up assessment of its impact. Professor Bainbridge, who
told us that such monitoring had been discussed by ACNFP, pointed
out that there was a danger that such monitoring could create
the false impression that the Government had doubts over the safety
of the GM products it was allowing into the human food chain.
This may represent a presentational problem for the Government
but it is not a reason to avoid conducting necessary evaluation.
The Medical Research Council (MRC) told us "the most effective
means of establishing the long-term effect of particular GM foods
on human health will be the randomised controlled trial"
and that researchers were beginning to develop practical methodologies.
We recommend that the Government supports efforts to find valid
ways of monitoring any long-term impact on health of consuming
123 See for example
Ev. p. 211. Back
p. 184. Back
p. 185. Back
p. 21; Ev. p. 35. Back
p. 139. Back
p. 138. Back
p. 138. Back
p. 138. Back
p. 216. See also Ev. p. 212; Ev. p. 219; Ev. p. 241. Back
p. 39. Back
p. 39. Back
p. 223. See also Ev. p. 55; Ev. p. 180; Ev. p. 183; Ev.
p. 212; Ev. p. 216. Back
p. 238. Back
Royal Society, The Regulation of Biotechnology, February
1999; Ev. p. 195. Back
The Commercial Use of Genetically Modified Crops in the UK:
the Potential Wider Impact on Farmland Wildlife. See
also ACRE 1998 Annual Report, March 1999, p. 5. Back
Ev. p. 64; Ev. p. 179; Ev. p. 261; Ev. p. 221. Back
Paper 11-II, Q. 603. Back
p. 216. Back
pp. 70-1. Back
p. 261; Ev. p. 194. See also Ev. p. 210. Back
15 April 1999, column 301-302. Back
from the Government, dated 18 February 1999. Back
p. 253. Back
p. 189. Back
p. 87. Back
p. 209. Back