Memorandum by the Organisation for Economic
Co-operation and Development
1. For the purpose of this evidence, it is necessary
to define precisely what are "genetically modified"
or "biotechnology" products, since both of these terms
(and in particular "biotechnology") can be used somewhat
indiscriminately to describe products developed by a variety of
traditional and novel techniques. For the purpose of this evidence,
the described work on safety and regulation of biotechnology products
is relevant to agricultural products developed using the techniques
of recombinant DNA technology.
2. The Member countries decided in 1980 that
biotechnology issues should be a part of the OECD work programme.
In 1982, "Biotechnology: International Trends and Perspectives"
was published. Authored by Professors Alan Bull (University of
Canterbury), Geoffrey Holt (The Polytechnic of Central London)
and Malcolm Lilly (University College London) this report drew
upon the expertise of 14 experts from Europe, Japan and the United
States. The report focused primarily on biotechnology (in this
case recombinant DNA and other techniques) and micro-organisms,
and resulted in a number of recommendations with respect to research
and development, training, industry-university links, economic
impacts, and patents, and specifically recommended that there
was a necessity to study and implement new and pragmatic safety
3. In response to this recommendation, and as
requested by the OECD Committee for Scientific and Technological
Policy, an Ad hoc group of almost 80 national experts (The
Group of National Experts on Safety in Biotechnology) made up
from 22 of the OECD Member countries, including five from the
United Kingdom and seven from the Commission of the European Communities,
published "Recombinant DNA Safety Considerations: Safety
Considerations for Industrial, Agricultural and Environmental
Applications of Organisms Derived by Recombinant DNA Techniques".
This 1986 report is commonly referred to as "The Blue Book".
4. In the Blue Book, the group of national experts
makes a clear distinction between traditional biotechnologies,
such as the use of micro-organisms for wine production and the
selection and breeding of agricultural crop plant varieties, and
the new techniques using recombinant DNA (more commonly called
"genetic engineering"). In the Blue Book, which made
the fundamental point that any risks raised by recombinant DNA
organisms are expected to be of the same nature as those associated
with conventional organisms, are specific recommendations, the
first step in the harmonisation process of safety principles and
practices among the Member countries of the Organisation. In the
early 1980s, consideration focused primarily on recombinant DNA
safety in laboratory and industrial fermentation systems, and
the 1986 Blue Book made corresponding recommendations on safety
criteria for "Good Industrial Large Scale Practices".
With respect to agricultural and environmental applications of
recombinant DNA the Blue Book made the following recommendations:
use the existing considerable data
on the environmental and human health effects of living organisms
to guide risk assessments;
ensure that recombinant DNA organisms
are evaluated for potential risk prior to applications in agriculture
and the environment by means of an independent review of potential
risks on a case-by-case basis;
conduct the development of recombinant
DNA organisms for agricultural or environmental applications in
a stepwise fashion, moving where appropriate, from the laboratory
to the growth chamber and greenhouses, to limited field testing
and finally, to large-scale field testing;
encourage further research to improve
the prediction, evaluation and monitoring of the outcome of applications
or recombinant DNA organisms.
5. In the Blue Book, the Group of National Experts
chose not to consider ethical issues, but rather, paid specific
attention to the identification of scientific criteria relevant
to the safety assessment and safe use of recombinant DNA products.
The publication of the Blue Book was timely as many countries
were setting up the regulatory structures considered necessary
for notification and assessment of biotechnology products, prior
to their proposed introduction into the environment for testing
or for commercial use.
6. The OECD Council adopted the "Blue Book"
recommendations in 1986, thus expressing a high degree of commitment
by Member countries to adopt the common scientific framework set
out in report.
7. In 1992 the Group of National Experts published
"Safety Considerations for Biotechnology", which elaborated
upon the principles set down in the "Blue Book", emphasising
Good Industrial Large-Scale Practice for the use of genetically
engineered micro-organisms, but more importantly for agricultural
purposes, the design of small-scale field research with genetically
modified plants and micro-organisms. This was followed in 1993
(77 experts including seven from the United Kingdom) with "Safety
Considerations for Biotechnology: Scale-up of Crop Plants",
and in 1994 (130 experts including 11 from the United Kingdom)
"Safety Considerations for Biotechnology: Scale-up of Micro-organisms
8. These two publications, apart from reaffirming
the basic "Blue Book" safety principles in a "Preamble",
developed further the principles of safety assessment and environmental
safe use of genetically engineered plants and micro-organisms.
In particular, the crop plant document, using the concept of "familiarity",
explained how existing data on crop plant species development,
the novel attribute engineered into the plant, the environment
of proposed introduction, and information on crop plant species/environment
interactions are all relevant in the case-by-case safety assessment
of genetically engineered crop plants.
9. The basic principles having been set out
by the Group of National Experts, biotechnology work at the OECD
then split into two areas: that of basic and applied research
and intellectual property rights, which came under the purview
of the Working Party on Biotechnology reporting to the OECD Committee
for Scientific and Technology Policy; and plant and micro-organism
biosafety which is conducted by the Expert Group on Harmonisation
of Regulatory Oversight in Biotechnology, formed in 1994 and which
is under the purview of the Joint Meeting of the Chemicals Group
and Management Committee, also makes its work available to the
OECD Environmental Policy Committee.
10. The first task of the Expert Group on Harmonisation
was to survey Member countries on their biotechnology regulatory
processes, on the information requirements detailed under those
regulations, and on agricultural products that were commercialised.
Details of these can be found in Monographs 99, 100 and 107 published
in 1995: "Commercialisation of Agricultural Products Derived
through Modern Biotechnology: Survey Results"; "Analysis
of Information Elements Used in the Assessment of Certain Products
of Biotechnology"; and; "Report of the OECD Workshop
on the Commercialisation of Agricultural Products Derived through
Modern Biotechnology" [these publications are enclosed] [not
11. The survey showed that, among the Member
countries, the regulation of biotechnology products was the responsibility
of a variety of different government agencies, and that their
authorities were achieved through new legislation, existing legislation
that had been modified or through published guidelines. Nonetheless,
Member countries were adhering to the basic safety principles
published in the "Blue Book" thus bearing out the commitment
made by OECD Council, in 1986, when it adopted the common scientific
framework for biotechnology safety. The analysis of information
elements required for safety assessment was particularly interesting,
as it showed a very great similarity among the Member countries.
These surveys show that, at the technical level, there is already
considerable harmonisation of biosafety assessment principles
among the Member countries.
12. Given the common approach to regulation
of biotechnology products among the Member countries, the Expert
Group on Harmonisation (which includes delegates from the UK)
then developed a work plan that would provide more detailed science
on the specific biology of plants and micro-organisms, the specific
novel traits being engineered into these, and issues of risk resulting
from specific types of modification. These "Consensus Documents"
which reiterate the common "Preamble", present scientific
data that is mutually recognised by the Member countries, and
which is intended to assist in regulatory decision making. In
fact, these Consensus Documents may be considered as case-by-case
technical descriptions of the components of "familiarity",
described in the 1993 "Safety Considerations for Biotechnology:
Scale-up of Crop Plants".
13. To date four Consensus Documents have been
made available for general distribution: "Consensus Document
on General Information Concerning the Biosafety of Crop Plants
Made Virus Resistant through Coat Protein Gene-Mediated Protection";
"Consensus Document on Information Used in the Assessment
of Environmental Applications Involving Pseudomonas";
"Consensus Document on the Biology of Brassica napus
L. (Oilseed rape)"; and, "Consensus Document on the
Biology of Solanum tuberosum subsp. tuberosum (Potato)".
[These publications are enclosed.] [not printed.] The Expert
Group has a number of plant and micro-organisms biology consensus
documents, as well as specific and general novel trait documents,
under development and anticipates their publication for general
use on a regular basis.
14. As an outreach activity, the Expert Group
makes all of its work available on its Internet site "BioTrack
Online" [see enclosed information] [not printed].
This includes links to the regulatory agencies in the Member countries,
information on field tests and commercialisation of biotechnology
products, and published consensus documents. This information,
which is available to all interested persons, provides transparency
to the biotechnology regulatory processes in the Member countries
and assists in enabling greater regulatory harmonisation. Also,
through its outreach programme, and with the assistance of the
United Nations Environment Programme and the United Nations Industry
Programme, scientific information from non-member countries that
are centres of origin and diversity of crop plant species is available
for inclusion in the crop plant species biologies.
15. With respect to point 1(c) in your letter,
the OECD member countries have also worked on the safety of novel
foods, though not specifically on the issue of whether or how
they should be labelled. "Safety Evaluation of Foods Derived
by Modern Biotechnology: Concepts and Principles" was published
16. This food safety work was undertaken by
the Group of National Experts (59 participants including two from
the UK and three from the Commission of the European Communities)
and is directly related to the 1986 "Blue Book" and
the 1992 "Safety Considerations for Biotechnology".
The Group of National Experts, recognising benefits to health,
nutrition and food preservation resulting from the application
of modern biotechnology to food production and processing, elaborated
on the scientific principles necessary to assure that the safety
of new foods and food components will be at least substantially
equivalent to that of widely accepted conventional counterparts.
The working group developing the document considered the application
of the concept of "substantial equivalence" to be the
most practical way to address the issue of food safety. This concept
is based on a comparison of a novel food with a traditional food
counterpart that has a safe history of use. The publication presents
examples of novel food safety assessment through a series of micro-organism,
plant, and animal case studies.
17. In 1994, the OECD held a workshop, "Food
Safety Evaluation", with collaborative support from the World
Health Organisation, in Oxford, UK (52 delegates including 10
from the UK and two from the Commission of the European Communities).
This workshop further explored strategies that could be used in
establishing the safety of biotechnology derived foods when no
conventional counterpart exists for comparison.
18. In 1997 another OECD workshop "The
Toxicological and Nutritional Testing of Novel Foods" [report
in Press], was held in Aussois, France (in attendance were 64
delegates including three from the Commission of European Communities
and seven from the UK). The workshop affirmed the conclusions
and recommendations of previous consultations of OECD and of the
FAO/WHO regarding the utility of the concept of "substantial
equivalence" in establishing the safety of foods and food
components derived from genetically modified organisms, and noted
that the concept had broader application establishing the safety
of novel foods. The 1996 FAO/WHO consultation referred to had
concluded, in line with earlier FAO, WHO and OECD recommendations,
that the food safety considerations regarding organisms produced
by recombinant DNA technology are basically of the same nature
as those that might arise from other ways of altering the genome
of an organism, such as conventional breeding. That consultation
also agreed that the comparative approach embodied in the OECD
concept of "substantial equivalence" is the basic tool
in the assessment used to establish the safety of foods derived
from genetically modified plants.
19. As part of an OECD study on regulatory reform,
"Uses of Food labelling Regulations, the OECD Report on Regulatory
Reform: Volume I", was published in 1997. This study provides
an overview of labelling regulations in the context of the food
industry as a whole. Where appropriate, particular reference is
made to the potential value of labelling regulations in ensuring
food safety. I would draw your attention in particular to section
V.3.: "Process Attributes: Use of Biotechnology and Environmental
Impacts." This publication is submitted for your consideration
20. Finally, "Biotechnology for Clean Industrial
Products and Processes" [in Press], while not directly addressing
agricultural biotechnology, states in a chapter on "National
and International Policies" that:
International agreements often serve
as a basis for national policies and legislation on clean industrial
products and processes.
Government policy is a major driving
force for clean technologies but can have positive or negative
effects, so that both of these require careful consideration.
While many countries consider biotechnology
as a critical enabling technology, they have not identified it
as a preferred tool for achieving cleaner products and processes;
Policies that affect the marketplace
can be most effective in driving change.
Consequently "Government policy, as reflected
in regulation, legislation and guidance is recognised as a major
driving force behind cleaner technologies, and in many cases and
countries, the single most decisive factor in their development
and diffusion." The report was developed by an Ad hoc
task force responsible to the Committee for Scientific and Technological