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Research
2000
International Approaches to Non-Science Issues in Regulating the Products of Biotechnology
Prepared for
The Canadian Biotechnology Advisory Committee Project Steering
Committee on the Regulation of Genetically Modified Foods
By Ozzie Silverman
November 2000
Table of Contents
-
The Emergence of Non-Science Issues in
Regulating Biotechnology
-
Methodology
-
Reconciling Science and Non-Science
Considerations Practices in Other Countries
-
3.1 Overview
-
3.2 United States
-
3.3 European Union
-
3.4 Denmark
-
3.5 Britain
-
3.6 France
-
3.7 Norway
-
3.8 Australia
-
3.9 New Zealand
-
3.10 Japan
-
3.11 Argentina
-
Emerging Best Practices
-
Annex 1 - References
Executive Summary
In August 1998, the Federal Government announced the Canadian
Biotechnology Strategy. The Strategy included a commitment to
integrate social, ethical, health, economic, environmental and
regulatory considerations. This reflected the fact that the
biosciences are still evolving rapidly and scientific developments are
creating challenges for regulatory systems in numerous countries, both
at the science and non-science levels.
This report contains the findings of a study commissioned by the
Canadian Biotechnology Advisory Committee to:
-
identify and analyze the practices of selected foreign governments
in addressing non-science issues when regulating the products of
biotechnology;
-
compare and contrast the approaches used in the various
jurisdictions to consider and reconcile science and non-science
factors in the regulatory process; and
-
summarize the current practices and strategic directions of the
governments surveyed.
The countries reviewed were the United States, Denmark, Britain,
France, Norway, Australia, New Zealand, Japan and Argentina. As well,
the European Union is included. Its framework laws provide the
foundation for the regulatory processes in the fifteen Member States.
The applications examined are medical products, food products, crops,
the environment (including sustainable development), and aquaculture.
Across the jurisdictions examined, the main non-science issues that
currently have implications for the regulation of biotechnology are of
three types. Ethical and social issues are separated, but the latter
could be considered ethical in nature.
Ethical in nature, for example:
-
various issues raised by the human medical applications of the
products and techniques of biotechnology;
-
that it is unethical to treat nature in an industrial fashion; and
-
that genetic modification is unnatural and an improper tampering
with nature (e.g. creating combinations of genes not found in
nature).
Social in nature, for example:
-
concerns, fears, and anxieties of the public about the human safety
of genetically modified foods, both in the near and longer-term;
-
a demand to be allowed to have the choice to eat or avoid GM foods,
as a matter of principle;
-
concern by vegetarians, vegans, and religious groups that animal
genes are being introduced into plants;
-
concern that over time, the economic value of the environment will
be damaged through GM crops and plants; and
-
concern that biodiversity will be diminished in unexpected ways
that will create problems down the road or are unacceptable in
principle.
Legal in nature:
-
arising primarily from ethical issues that emerge as a result of
new applications made possible by continuing developments in
science, and the lack of adequate legal policy frameworks to deal
with these issues.
Some of these non-science issues have emerged because GM foods have
not yet had obvious direct benefits for consumers. Consumers perceive
potential risks or have other concerns. They therefore question the
necessity of developing GM foods, on an ethical or purely practical
basis, but don’t have balancing considerations.
Current government policies and practices internationally are
summarized below.
There are a number of conclusions that can be drawn from the study:
-
Governments need ongoing structures to deal with non-science issues
that are separate from, but complementary to, the regulatory
approval process.
-
Non-science considerations, to the extent they are relevant in the
regulatory process, should be incorporated into the framework
legislation or policies that govern that process, to the maximum
extent possible.
-
The regulatory process for individual products and techniques must
be based upon scientific assessments, in order to avoid uncertainty
that would stifle investments in research, and have a negative
impact on the flow of new developments that would benefit the
public.
-
How non-issues are dealt with by government has an important impact
on the public acceptance of the products and techniques of
biotechnology. This is a responsibility of government.
-
To the extent feasible, it is preferable that governments
anticipate nonscience issues and address them early on, to avoid
having them become publicly controversial.
-
It does not appear to be possible to develop a set of guiding
ethical principles that would be sufficient for resolving all
ethical issues that will arise. Nevertheless, it would appear to be
useful to develop such principles, both as a way of developing a
consensus on what is permissible and not permissible in a society,
and guide the evolution of the policy framework for the regulatory
system.
Various mechanisms for considering non-science issues have been put in
place over the years and those that appear to have been effective
within their socioeconomic environment can be considered to be
emerging best practices. These practices are set out in Section 5,
together with the rationale for each.
-
The Emergence of Non-Science Issues in
Regulating Biotechnology
Biotechnology and genetic engineering raise many new ethical
issues. Ethical decision-making deals with difficult questions
of right and wrong or good and bad. Ethical issues in the
context of biotechnology regulation relate to the application of
moral values to complement scientific assessments. Regulations
could be viewed as acceptable if they respect ethical values and
principles that are appropriate to a particular decision-making
situation and to a society’s values.
Ethical concerns fall into two classes – intrinsic and
extrinsic. Intrinsic concerns deal with things that are
considered to be wrong per se, such as the cloning of human
beings. Genetic engineering techniques in particular (as opposed
to products) that apply to humans and animals tend to give rise
to intrinsic concerns.
Extrinsic concerns involve the application of developments,
neutral in themselves, that are open to misuse and may cause
harm. Genetically modified crops and food products might fall
into this category. Such concerns are often described as social
issues.
Many ethical arguments hinge upon weighing risks and benefits.
It is often the case that the public perceives risks but not
benefits. For example, the variety and supply of food in most
western countries is plentiful and the public does not see a
pressing need for genetically modified foods. Moreover, most of
the benefits to date have been at the crop production level.
Therefore, consumers have not received direct benefits, but are
faced with various uncertainties. The nature and extent of the
public’s concerns vary across countries.
Ethical issues can change over time. The values that determine
what is ethically acceptable can be conditioned by religious
beliefs and cultural orientation. Scientific developments have
had the effect of re-defining ethical issues over time. As well,
the press and advocacy groups have played a significant role in
shaping public beliefs and attitudes.
There is another school of ethical thought that is based upon
natural law. Under natural law, genetic engineering is seen as
unnatural. Not tampering with what God has created falls into
this category.
The report of the Nuffield Council on Bioethics on Genetically
Modified Crops: The Ethical and Social Issues (May 1999)
contains a detailed examination of ethical/social concerns and
their merit.
Industry internationally is concerned about the commercial
uncertainty and financial risk that it would be exposed to if
some non-science issues that are outside of current legislation
were to become part of the regulatory approval system for
biotechnology products, or if non-science issues could be
introduced into the regulatory approval process in an ad hoc
case-by-case basis.
-
Methodology
The objective of the study was to:
-
identify and analyze the practices of selected foreign
governments in addressing non-science issues when regulating
the products of biotechnology;
-
compare and contrast the approaches used in the various
jurisdictions to consider and reconcile science and
non-science factors in the regulatory process; and
-
summarize the current practices and strategic directions of
the governments reviewed.
The methodology employed was to :
-
review the literature on the regulatory systems and practices
in the United States, the European Union, Denmark, Britain,
France, Norway, Australia, New Zealand, Japan and Argentina;
-
augment that information through contacts with officials, as
necessary;
-
carry out a comparative analysis of the various approaches
and practices in these jurisdictions; and
-
identify the apparent emerging best practices.
The following aspects were examined. They constituted the
framework for the analysis.
-
Nature of Non-Science Issues
-
The identification of the types of non-science issues
that have arisen in each country examined, and how they
are dealt with by government.
-
Institutional Structure
-
The structure(s) by which non-science considerations in
biotechnology regulation have been institutionalized.
-
Ethical Principles and Approaches
-
The existence, nature and extent of a framework of
ethical principles or other approaches that are
employed to guide regulatory decisionmaking.
-
Public Input
-
Whether, the extent to which, and by what structure,
there is public input into the regulatory process, on
non-science issues.
-
Socio-economic Assessment
-
The extent to which socio-economic analyses of proposed
and existing biotechnology products are conducted as
part of, or in addition to, the regulatory
decision-making process.
-
Regulatory Decision-Making Process
-
The extent to which, and mechanics whereby, non-science
considerations enter into the regulatory
decision-making process
-
The extent of participation of the public in the
decision-making process.
-
Emerging Best Practices
-
The apparent emerging best practices across the various
jurisdictions for dealing with non-science issues.
-
Reconciling Science and Non-Science
Considerations Practices in Other Countries
This section reports on the findings of the review of the
non-science aspects of the biotechnology regulatory system in
each of the nine countries and the European Union.
-
3.1 Overview
Current government policies and practices internationally
are summarized below.
-
The regulatory approval process for the products of
biotechnology is constructed almost exclusively on
science-based considerations in almost every
jurisdiction.
-
With the exception of certain practices in Norway and
the testing of medical products at the investigational
stage, non-science issues are taken into account only
if they are contained in the legislation or framework
policy that governs the regulatory approval process.
Therefore, ad hoc non-science issues do not enter into
the decision-making. Norway, which is not a Member
State of the EU, has provisions in its legislation that
permit a specific regulatory application to be
submitted to its Biotechnology Advisory Board. This is
a group that includes experts in the natural sciences,
law, and philosophy, as well as representatives of
environmental groups, farmers’ associations,
trade unions, etc. In certain cases, such as for
applications to market a product with GMOs, the
regulator is permitted to consult the general public
through a public hearing.
-
The introduction of ad hoc non-science issues into the
established regulatory decision-making process would
lead to uncertainty and considerable financial risk for
applicants. This would deter investments in
biotechnology R&D and reduce the flow of benefits
that the public obtains through the applications of
biotechnology. The European Union recognized the
existence of this problem in 1991, when the European
Commission issued a Policy Statement on the subject.
-
Non-science issues are considered to be important in
all jurisdictions. While is no consensus
internationally on how social concerns should be
reflected in the regulatory system, progress is being
made in some countries in institutionalizing structures
and processes to deal with such concerns.
-
The role of non-science issues in the regulatory
approval process can be illustrated by the situation
with respect to GM foods. The OECD reports (May 2000)
that certain Member countries face challenges in
reconciling social, economic, environmental and ethical
aspects of the products of biotechnology, with
science-based regulatory frameworks. The view as to the
extent to which socio-economic concerns should
influence risk decisions varies across OECD countries.
Many consider economic cost, technical feasibility, and
risk perception, to be legitimate factors in risk
management decisions. Nevertheless, socio-economic
impact studies are not carried out as a routine part of
the regulatory approval process for the products of
biotechnology.
-
The question of whether socio-economic concerns such as
animal welfare, the environment and biodiversity should
be addressed within, or separate from, the food safety
regulatory system is more controversial. Some countries
emphasize the importance of taking account of such
factors in their food safety regulations. Others stress
that the integrity and credibility of their
science-based food regulatory systems could be
undermined by the introduction of other factors. There
is as yet no agreement between OECD countries on the
detailed process of assessing consumer concerns about
GM foods and crops. Moreover, there is still
uncertainty over the long-term environmental effects,
potential complex ecological interactions, and impacts
on biodiversity.
-
An environmental impact assessment is generally a
component of the regulatory approval process for the
release of GMOs. However, an assessment for sustainable
development is not common. The latter is an integral
part of Norway’s system.
Structures and Mechanisms For The Consideration of
Non-Science Issues
Internationally, the consideration of non-science issues
has been institutionalized primarily through the following
structures and mechanisms:
Socio-economic Assessments
In 1998, the OECD published the results of its study on
the Economic Aspects of Biotechnologies Related to Human
Health. An important finding was that socioeconomic data
are not being considered in any consistent way by
regulators, as part of the approval process for
biotechnology products. Neither did the present study come
across any evidence that socio-economic impact studies of
proposed genetically modified foods are a feature of the
regulatory system in the various jurisdictions.
Socio-economic factors can and do play a role at the
adoption and diffusion stage.
The OECD identified a number of methodological
difficulties encountered when trying to undertake
socio-economic impact assessments of new biotechnology
products for medical use. These difficulties include the
following:
-
“Breakthrough”: As
“breakthrough” products, biotechnology
products may suffer from the fact that the nature of
the disease is not well understood, and appropriate
instrumentation for measuring clinical
“success” may not be developed.
Consequently, the clinical “learning curve”
may be steeper for biotechnology products, and early
clinical or economic assessments may be misleading.
-
Economic assessments: Economic
assessments are difficult at an early stage in the
development of biotechnologies. Since in many
jurisdictions, important pricing and reimbursement
decisions are made at the time when the product is
launched, there is the risk that promising developments
may be curtailed because they are initially thought to
give poor value for money.
-
Lack of comparison: Because they seek
to fill major gaps in therapy, and because there are no
existing therapies to serve as a comparison, price
setting is difficult for some biotechnology products.
Many such products are presented as a “magic
bullet” which deserves a high price. In addition,
genuine difficulties in R&D and manufacture may
lead to high costs. Because of the perceived high
price, biotechnology products may be singled out for
detailed evaluation by decision makers, although not
more than conventional pharmaceuticals of a similar
price. In such cases, appropriate application of
economic evaluation is important because a high price
does not necessarily imply poor value for money.
-
Registration of new drugs: Many
clinical trials for the registration of new drugs tend
to use short-term or surrogate endpoints, rather than
more meaningful endpoints such as survival or improved
quality of life. This means that the estimation of
benefits in economic evaluation (e.g. life-years or
quality-adjusted life-year gains) usually requires
extrapolation and assumptions.
-
Anticipation of Non-Science Issues: To
the extent ethical issues can be anticipated and
considered before they become the subject of public and
medical concern and possibly distortion, both the
regulatory and social systems would benefit. The Danish
Council of Ethics is apparently the only body that has
initiated work to determine the feasibility of
developing a methodology that will identify such issues
at the research stage.
-
Transparency: Non-science issues are
dealt with in a fairly transparent way across all of
the jurisdictions reviewed. Nevertheless, this does not
guarantee that the public is knowledgeable about
domestic laws, policies and practices.
-
Ethics Bodies: Most of the
jurisdictions reviewed have an ethics advisory body
that deals with ethical issues arising from the
application of biotechnology. All have been appointed
by government. The table that follows illustrates the
variation in their mandates. The Norwegian
Biotechnology Advisory Board has a mandate that is
unique. It can be called upon to play a direct role in
product approval.
Key Features of Bioethics Advisory
Groups
|
Feature
|
United States
|
European Union
|
Denmark
|
|
Legal Status
|
National Bioethics Advisory Commission
established by Presidential Executive Order in
1995.
|
Group of Advisors on the Ethical Implication of
Biotechnology (est. by EC in 1991), superseded by
the European Group for Ethics in Science and New
Technologies (1997)
|
Danish Council of Ethics created through
legislation in 1987.
|
|
Mandate
|
Provides advice and recommendations to NSTC and
federal agencies on bioethical issues arising
from research and its applications. Has a medical
focus.
|
Provides opinions on variety of ethical issues.
Advises the European Commission. Focus includes
humans, plants, animals.
|
Advises health authorities on ethical issues that
arise from new methods and techniques of
treatment; informs the public and promotes public
debate on science developments and ethical
issues.
|
|
Composition
|
Eighteen members appointed by the President.
Composed of experts only.
|
Twelve members appointed by the European
Commission. All members are professionals.
|
Seventeen members. Eight appointed by the
Minister of Health. Nine appointed by Parliament.
Broad representation of professionals and lay
persons.
|
|
Method of Operation
|
Meets as an expert group. Prepares and publishes
reports on selected issues, as well as annual
report.
|
Advisory, independent and multidisciplinary.
Deliberations are confidential. All opinions
published, as well as annual report.
|
Not a traditional expert body. Seen as a forum
for public debate and preparation of opinions
that reflect diverse views.
|
|
Nature of Biotechnology Issues Dealt With
|
Research use of human biological materials;
genetic tissue samples; oversight of federal
research on human subjects; cloning human beings;
etc.
|
Legal protection of biotechnology inventions;
labelling of foods; prenatal diagnosis, genetic
modification of animals; cloning techniques; etc.
|
Assisted reproduction; patenting of biotechnology
inventions; genetic testing; patients’
rights; xenotransplantation; etc. Attempts to
anticipate ethical issues at the research stage.
|
|
Role in Regulatory Decision-Making
|
No direct role. Has overview role of how federal
agencies regulate research involving human
subjects.
|
Provides advice on biotechnology framework
legislation. No direct regulatory decision-making
role.
|
Provides advice on proposed EC and Danish
framework laws. No direct regulatory role.
|
|
Core Ethical Principles
|
In the Executive Order, the NBAC is directed to
identify broad principles to govern the ethical
conduct of research.
|
Based primarily on the development of
case-by-case experiences over time.
|
Has developed some basic principles, as a
starting point for considering specific ethical
issues.
|
|
Public Input
|
Not explicitly provided for. NBAC may conduct
inquiries and hold hearings.
|
Not provided for.
|
Unique role in interacting with and educating the
public and politicians.
|
Key Features of Bioethics Advisory
Groups
|
Feature
|
Britain
|
France
|
Norway
|
|
Legal Status
|
Revised and streamlined structure consists of
three strategic advisory bodies that report to
Ministers.
|
National Consultative Ethics Committee for Health
and Life Sciences established by government in
1983 by decree and given legislative basis in
1994.
|
Norwegian Biotechnology Advisory Board
established by the Government.
|
|
Mandate
|
Consider broader issues regarding the
acceptability of biotechnology, including
ethical; identify gaps in the regulatory
framework (science and non-science)
|
Gives opinions on ethical problems raised by
progress in the fields of biology, medicine and
health. Is a consultative body.
|
Maintains awareness of developments in
biotechnology related to humans, plants, animals.
Evaluates ethical and other social issues.
Proposes legislation. Comments on issues arising
from existing legislation.
|
|
Composition
|
Each body had 15-20 expert members selected to
cover range of interests and issues.
|
Forty members drawn from religious faiths,
philosophy, ethicists and scientists.
|
Experts and lay representatives of sector
interest groups.
|
|
Method of Operation
|
Establishment of working groups; openness and
transparency.
|
Issues opinions and press releases. Holds annual
public conference.
|
Issues reports and press releases on ethical
issues.
|
|
Nature of Biotechnology Issues Dealt With
|
Biotechnology foresight, social, ethical, legal
and economic in the areas of human health, GM
foods, agriculture, and the environment.
|
Review of France’s laws on bioethics is
most recent project. Has issued sixty opinions
since 1984.
|
Cloning of humans; extensive advice on government
framework legislation related to genetic
technologies; DNA tests; etc.
|
|
Role in Regulatory Decision-Making
|
Advisory bodies do not oversee the work of the
regulatory technical bodies. However, they can
influence regulatory framework policies.
|
No direct role in regulatory approvals.
|
The Board can be consulted at any time when
specific products or investigational therapies
are being considered by the regulators.
|
|
Core Ethical Principles
|
No indication yet that this approach will be
adopted.
|
Ethical principles are contained in the numerous
opinions on biotechnology issued by the National
Consultative Committee For Health and Life
Sciences (eg. respect for human dignity).
|
Ethical principles for medical products, medical
techniques and plants/ animals are specified in
legislation.
|
|
Public Input
|
Each advisory body consults stakeholders and the
public on issues it is considering.
|
Approach is one of communications to, rather than
engagement with, the public. Exception is annual
conference.
|
The Board has a mandate to disseminate
information and contribute to communications by
government, scientists and lobby groups.
|
Overview of International Approaches To
Non-Science Issues
|
Jurisdiction
|
United States
|
European Union
|
Denmark
|
|
Characteristics
|
|
Nature of Main Non-Science Issues
|
-
ethical issues related to human genetic
manipulation, therapeutics and techniques
|
-
ethical and consumer acceptance
|
-
primarily ethical in nature
-
genetically modified foods
|
|
Role of Non-Science Issues in Regulatory Decision
Making
|
-
ethical issues may arise when approving
experimental use of investigational drugs
-
FDA focuses on safety & efficacy in
product approvals
|
-
ethical issues reflected in EC framework
legislation
|
-
have been codified in legislation governing
biotechnology
|
|
Public Input - The Regulatory Process
|
-
through participation on scientific
advisory committees
|
-
not part of the regulatory approval process
|
-
not part of the regulatory approval process
|
|
Institutional Structures For Advice on
Non-Science Issues
|
-
US National Bioethics Advisory Commission
-
FDA scientific advisory committees
|
-
European Group For Ethics in Science &
New Technologies
-
EC Consumer Committee
|
-
Danish Council of Ethics
-
Danish Board of Technology
|
|
Best Practices
|
-
role of consumers on scientific advisory
committees
|
-
the mechanisms for addressing consumer
issues
-
the linkage between framework legislation
and EC ethics advisory body
|
-
public education/ consultation activities
of the Danish Council of Ethics
|
Overview of International Approaches To
Non-Science Issues
|
Jurisdiction
|
Britain
|
France
|
Norway
|
|
Characteristics
|
|
Nature of Main Non-Science Issues
|
-
public acceptance of genetically modified
foods and plants
|
-
ethical and consumer acceptance
|
-
primarily ethical
-
labelling of genetically modified foods
|
|
Role of Non-Science Issues in Regulatory Decision
Making
|
-
ad hoc nonscience issues not considered but
advice from advisory committees can be
reflected in regulatory policy
|
-
evaluation of biotechnology products based
only on scientific factors
|
-
legislation permits Norwegian Biotechnology
Advisory Board to be consulted by
regulators
|
|
Public Input - The Regulatory Process
|
-
not part of the regulatory approval process
|
-
not part of the regulatory approval process
-
consumers represented on Commission du Génie
Biomoléculaire
|
-
general public may be consulted as part of
regulatory process
|
|
Institutional Structures For Advice on
Non-Science Issues
|
-
Food Standards Agency
-
Human Genetics Commission
-
Agriculture and Environment Biotechnology
Commission
|
-
National Consultative Ethics Committee For
Health and Life
|
-
Norwegian Biotechnology Advisory Board
|
|
Best Practices
|
-
three advisory bodies are mechanism to
anticipate and consider emerging science
and non-science issues
|
-
Conseil national de l’alimentation,
as a forum for consumers
|
|
Overview of International Approaches To
Non-Science Issues
|
Jurisdiction
|
Australia
|
New Zealand
|
Japan
|
Argentina
|
|
Characteristics
|
|
Nature of Main Non-Science Issues
|
-
desire on part of public and industry for
more transparent regulatory system
-
public concern about GM foods
|
-
New Zealand has not accorded a high
priority in the past to non-science issues,
except for aboriginal issues
|
|
|
|
Role of Non-Science Issues in Regulatory Decision
Making
|
|
|
-
S Decision Making role decisionmaking is
entirely science-based
|
-
there is no direct role except for analysis
of potential impact on domestic and
international markets of GM food approval
|
|
Public Input - The Regulatory Process
|
-
there is consultation process for community
input into decisions concerning the release
of GMOs into the environment and field
trials of GM crops
|
|
|
|
|
Institutional Structures For Advice on
Non-Science Issues
|
-
Gene Technology Community Consultative
Group (covers GMOs)
-
Gene Technology Ethics Committee (ethical
issues)
|
-
Independent Biotechnology Advisory Council
established by government in 1999. Provides
advice on environmental, economic, ethical,
social and health aspects
|
-
ad hoc consultations and communications
-
public comments procedure
|
-
Argentinean Forum of Biotechnology
(non-profit foundation) fosters public
awareness and debate
-
no dedicated ethics body
|
|
Best Practices
|
-
too soon to tell how effective
Australia’s new regulatory governance
system will be
-
National biotechnology strategy includes
funding to examine the costs and benefits
of GM products for the food and agriculture
industry
|
-
none evident
-
New Zealand launched twelve month Royal
Commission on Genetic Modification in mid-
2000, to carry out a comprehensive review
|
-
discussions of advisory bodies open to the
public and results posted on Internet
-
access by the public to materials submitted
by GM food developers
|
|
Lessons Learned
Based upon the approaches and experiences in the various
jurisdictions, the key lessons that can be drawn from the
study are as follows:
-
3.2 United States
Food Products
Food developed through biotechnology is regulated by the
FDA’s Center for Food Safety and Applied Nutrition
(CFSAN). In 1992, the FDA published a policy statement
setting out its legal and regulatory framework for the
oversight of foods derived from new plant varieties
developed by both conventional and new breeding
techniques, such as genetic engineering. Non-science
issues do not feature in the 1992 policy. Social and
ethical issues are currently outside the regulatory
process set out in the Food, Drug and Cosmetic Act.
The Act does not require disclosure in labelling of
information solely on the basis of the consumer’s
desire to know. (In Europe, the consumer’s right to
know is an important non-science consideration). The FDA
requires special labelling if the composition of a food
developed through genetic engineering differs
significantly from its conventional counterpart. Another
condition requiring labelling is when a genetically
engineered food unexpectedly gives rise to an allergen.
The conditions requiring labelling are science-based. As
of 1997, the FDA was not aware of any information that
would distinguish genetically engineering foods as a class
from foods developed through other methods, thereby
requiring such foods to the specially labelled to disclose
the method of development. style="margin-left:
6%;"A non-science issue that the FDA has contemplated
is whether special labelling should be required for a food
derived from a plant that has been modified to express a
gene derived from an animal, and whether the presence of
such a gene or its product affects ethical or religious
beliefs. As of 1999, no foods approaching the market
raised this issue.
CFSAN has a Food Advisory Committee that has a consumer
representative. The experience of the Center has been that
while consumer groups in the United States would like more
information on food labels, non-science issues have not
been a focus of their attention. Even groups concerned
with labelling have not raised this as an issue. However,
this should not be taken to imply that there are no
non-science issues associated with food production through
the use of genetically modified organisms. For example,
there has been public opposition in the US to the
Agriculture Department’s research on sterile seeds.
This is part of a trend in biotechnology research that is
also trying to find on-off switches for a plant’s
gene system, so that it would, for example, produce a
toxin on demand. One criticism of such research is that a
few large multinational companies will control and use
such breakthroughs in ways that will maximize their
profits. Another is that farmers in developing countries
cannot afford to buy seeds every year. This is the type of
issue that could benefit from a socio-economic analysis,
in order to establish public policy.
Medical Products
At the Food and Drug Administration, biotechnology-derived
medical products are regulated primarily by the Center For
Biologics Evaluation and Research (CBER). The Center For
Drug Evaluation and Research (CDER) is also responsible
for regulating some biotechnology products (eg.
recombinant hormones).
In 1994 and 1995, CBER senior managers developed a
strategic plan that would provide a vision for the Center
for the year 2004. It reaffirmed that science and law had
served as the basis for regulatory decision-making in the
past, and would continue to lead CBER into the next
century. A number of cross-cutting issues were identified
as essential for the success of the plan - accountability,
quality assurance, communications, training and team work.
Non-science issues of the type examined in the present
project were not identified. CBER’s FY1997 Annual
Report confirmed the continuation of the science and law
orientation.
Both CBER and CDER have Advisory Committees, all of which
are independent, scientific, and technical in nature. They
were established to provide expert advice and make
recommendations on issues related to the FDA’s
regulatory responsibilities. Final decisions are made by
the FDA. Not all regulated products are referred to the
Advisory Committees. For example, advice will be sought
for those cases that raise difficult issues.
Advisory committees weigh available evidence and provide
scientific and medical advice on the safety, effectiveness
and appropriate use of products under FDA jurisdiction.
Another role is to advise the Agency on general criteria
for evaluation and on broad regulatory and scientific
issues that are not related to a specific product. In this
regard, the FDA is placing more ethicists on Advisory
Committees. They are playing a particular role earlier in
the product development cycle, when investigational drugs
are being considered. However, ethical considerations do
not necessarily have a bearing upon whether the FDA
approves a product, particularly for marketing.
Recent changes in FDA legislation have responded to
demands by the public that they have access to new
therapies as soon as possible. The new Act has access
provisions to fast track therapeutics at the
investigational stage, particularly for life threatening
diseases. At this stage, there needs to be reasonable
protection for subjects. This may raise ethical issues.
However, the standard of approval has remained unchanged.
At the marketing approval phase, the risk/benefit criteria
remain unchanged. The Code of Federal Regulations contains
provisions on informed consent and protection of subjects
for investigational drugs.
Despite the greater attention being given to ethical
issues by the FDA, the CBER has not had a close working
relationship with the National Bioethics Advisory
Commission. The mandate and work of the Commission is
discussed below.
FDA Advisory Committees are required to have at least one
consumer representative as a member. Consumer
representatives are expected to have the ability to
analyze data, understand research design, discuss benefits
and risks, evaluate the safety and efficacy of the
products under Committee review, and lead discussions on
issues from a consumer’s perspective. In setting out
their role and qualifications, the FDA makes no mention of
non-science issues.
Most of the representatives selected have ties to consumer
and communitybased organizations. The FDA Office of
Consumer Affairs conducts an ongoing recruitment effort to
obtain nominations of candidates to serve as consumer
representatives.
Individual consumers and consumer groups can provide
comments and petitions on proposed FDA regulations. When
the FDA plans to issue a new regulation or revise an
existing one, it places an announcement in the Federal
Register. Usually, a file stays open for comments for at
least sixty days.
Crops
At the United States Department of Agriculture, several
groups are involved in regulating and monitoring the use
of biotechnology related to crops.
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Animal and Plant Health Inspection Service (APHIS)
regulates the movement, importation, and field testing
of GMOs through permit and notification procedures.
-
Food Safety Inspection Service (FSIS) has
responsibility for the safe use of engineered domestic
livestock, poultry, and products derived from them.
-
Foreign Agricultural Service (FAS) monitors foreign
regulations and restrictions of GMOs.
-
Agricultural Research Service (ARS) conducts in-house
research on GMOs.
-
Economic Research Service (ERS) conducts research on
the economic impact of GMOs.
-
Cooperative State Research, Education, and Extension
Service (CSREES) funds the biotechnology risk
assessment program, and research in gene mapping,
sequencing and biotechnology applications.
The notification procedure is the simplest way to obtain
APHIS permission to import, move, or field test a GMO and
is applicable in the vast majority of cases. To qualify,
plants must meet specific eligibility criteria and the
applicant is required to meet performance standards
designed to ensure biological containment. While only six
crops are eligible for notification (corn, cotton, potato,
soybean, tobacco, tomato), subsequent revisions to the
regulations have extended eligibility to nearly all plants
(noxious weeds excluded). Organisms that do not qualify
under the notification process, most notably
micro-organisms and pharmaceutical-producing plants,
require an APHIS permit.
To be commercialized, GMOs must conform with standards set
by State and Federal marketing statutes such as State seed
certification laws, the Federal Food, Drug, and Cosmetic
Act (FFDCA), the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the Toxic Substances Control Act
(TSCA), and the Federal Plant Pest Act. There are no
national requirements for varietal registration of new
crops.
Environment
The Environmental Protection Agency's role in
regulating biotechnology involves issuing permits for
large-scale testing of herbicides and
biotechnology-derived plants containing new pesticide
substances. In deciding whether to register a new
pesticide, the EPA considers human safety, the fate of the
substance in the environment, the safety for humans, its
effectiveness on the target pest, and any effects on
other, "non-target" species.
The Toxic Substances Control Act (TSCA) regulates
micro-organisms intended for commercial use that contain
or express new combinations of traits. This includes
"intergeneric micro-organisms" formed by
deliberate combinations of genetic material from different
taxonomic genera.
To commercialize an intergeneric micro-organism, or to
introduce such microorganisms into the environment for
research purposes, one must submit information to the
Office of Pollution Prevention and Toxic Substances. This
is regulated under the "Microbial Products of
Biotechnology: Final Regulation Under the Toxic Substances
Control Act", established in April 1997. OPPT
scientists review the information provided to determine
whether the intended activity may present an unreasonable
risk to health or the environment. Decisions on what
action to take for each submission are based upon these
reviews.
Aquaculture
The Food and Drug Administration’s Centre for
Veterinary Medicine (CVM) regulates, in whole or in part,
diverse animal biotechnology products, including
transgenic fish. Most transgenic animals under development
are regulated by one or more FDA Centers. There are
procedures to request approval to enter transgenic animals
into the food or feed supply. No approvals have been
granted for entry into the human food supply.
The procedures for biopharm animals (producing drugs or
biologics) are described in the 1995 Points to Consider in
the Manufacture and Testing of Therapeutic Products for
Human Use Derived from Transgenic Animals. For these types
of animals, as well as others generated by biomedical
research, the CVM serves as a consulting group to the
other FDA Centres in the food and feed safety evaluation.
Gene-based modifications of animals for production or
therapeutic claims fall under CVM regulation as new animal
drugs. Investigational applications are filed for these
modifications where, with a showing of adequate safety
data, the sponsor may request disposition of animals by
slaughter for food or for processing into animal feed
components.
To date, no transgenic fish have been approved for
producing food in the U.S. As there is active
investigation of transgenic fish abroad, as well as in the
U.S., the public and the research community are
occasionally exposed to predictions of the imminent
commercial release of transgenic fish into the food
supply. This would not occur without the pre-market
approval from CVM, for those fish that have an added
gene-based animal drug.
The US National Bioethics Advisory Commission
(NBAC)
In the Fall of 1993, the White House Office of Science and
Technology Policy (OSTP) was approached by the National
Institutes of Health (NIH), the Department of Energy
(DOE), and other research-oriented agencies to consider
supporting many longstanding calls for the United States
to establish a standing, expert, national commission on
bioethics. The proposal stemmed in part from a
congressional request that NIH and DOE establish an
advisory committee on genetic privacy. It was also
responsive to a growing chorus of voices suggesting the
need for such a commission to address a wide and growing
range of other unresolved issues in the area of bioethics.
One recommendation, which came directly from the Advisory
Committee on Human Radiation Experiments (ACHRE), called
for the creation of a committee to address the ethics of
research involving human subjects. As a result, OSTP
expressed the need for a high-level group to serve as a
shared resource to address a broad set of ethical issues,
including genetic privacy and the protection of human
subjects in research, and to complement specialized
committees and boards already supported by various
agencies.
The NBAC was established by the President’s
Executive order in October 1995. It has a maximum of
fifteen members, appointed by the President. It does not
have a direct role in the regulation of the products of
biotechnology. However, it has an influence on the
practices of those government agencies that conduct,
support, or regulate research involving human research
subjects. All the members are professionals and primarily
academics. Its mandate is to:
The NBAC is not responsible for the regulatory review and
approval of specific products.
In addition to responding to requests for advice and
recommendations from the NSTC, the NBAC may accept
suggestions of issues to consider, both from the Congress
and the public. The Commission itself may also identify
issues to examine. The Executive Order stipulates that as
a first priority, the NBAC was to direct its attention to
consideration of the “protection of the rights and
welfare of human research subjects, and issues in the
management and use of genetic information, including human
gene patenting”. The NBAC is directed to consider
four criteria in establishing the other priorities for its
activities:
-
the public health or public policy urgency of the
bioethical issue;
-
the relation of the bioethical issue to the goals for
Federal investments in science and technology;
-
the absence of another entity able to deliberate
appropriately on the bioethical issue; and
-
the extent of interest in the issue within the federal
government.
The NBAC submits its reports to the NSTC, through the
Assistant to the President For Science and Technology
Policy (Office of Science and Technology Policy).
Typically, the Commission is subsequently advised that
their report is being brought to the attention of federal
agencies. It is apparent that NBAC reports have raised the
profile of ethical issues at the FDA in relation to how
investigational therapeutics are authorized. In addition,
it is important to note that the Executive Order that
established the NBAC also required federal agencies to
review and report on their policies to protect the rights
and welfare of human research subjects. Section I of the
Executive Order included the following:
Review of Policies and Procedures.
-
Each executive branch department and agency that
conducts, supports, or regulates research involving
human subjects shall promptly review the protections of
the rights and welfare of human research subjects that
are afforded by the department’s or
agency’s existing policies and procedures.
-
Within 120 days of the date of this order, each
department and agency that conducts, supports, or
regulates research involving human subjects shall
report the results of the review required by paragraph
(a) of this section to the National Bioethics Advisory
Commission, created pursuant to this order. The report
shall include an identification of measures that the
department or agency plans or proposes to implement to
enhance human subject protections.
The NBAC has dealt with a broad range of subjects. The
following are provided as examples.
-
Research Involving Persons With Mental Disorders That
May Affect Decision-Making Capacity
-
Cloning Human Beings
-
Research Use of Human Biological Materials
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Research Involving Human Stem Cells
In June, 1997, the NBAC released its report Cloning Human
Beings. In response to recommendations in the report,
legislation prohibiting the use of fully differentiated
cells to clone human beings was transmitted by the
President to Congress.
Non-Science Issues
Legal authority for food labelling rests with the Food and
Drug Administration. Foods derived from biotechnology
currently must be labelled only if they differ
significantly from their conventional
counterparts—for example, if their nutritional
content or potential to cause allergic reactions is
altered.
In an effort to provide consumers with more information,
the Secretary of Agriculture has encouraged voluntary
labelling of biotechnology-derived products.
In July 1999, USDA Secretary Dan Glickman announced the
formation of the Secretary’s Advisory Committee on
Agricultural Biotechnology, to provide him with advice on
a broad range of policy issues relating to agriculture and
biotechnology. Its 38 members come from government,
academia, production agriculture, agribusiness, ethicists,
environmental and consumer groups. There are also seven ex
officio members from other federal departments and
agencies.
This Committee will also help facilitate a public dialogue
on biotechnology, ensuring the inclusion of diverse voices
and ideas. The Secretary has also encouraged industry and
consumers groups to seek more opportunities to engage in
an open dialogue and exchange of ideas.
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3.3 European Union
EU Policy on Non-Science Issues
In 1991, the European Commission (EC) published a policy
statement on the regulation of biotechnology that provides
a succinct overview of how it would deal with non-science
issues when regulating the products of biotechnology. The
regulatory criteria are safety, efficacy and quality. The
objective is to avoid introducing uncertainty into the
regulatory process. The existence of socioeconomic issues
is recognized and the door is left open for such issues to
impact regulatory decisions. The text below is an extract
from “European Industrial Policy For The 1990s
– Bulletin of The European Communities
(3/91).” It reflects the debate at the time as to
how socio-economic issues should be dealt with, and the
position taken by the EC.
“The approach now applied by the Community, based
upon the correct and thorough application of the criteria
of safety, quality and efficacy, in conjunction with
relevant horizontal legislation, ensures consumer safety
and economic interest and permits the protection of human,
animal and plant health and of the environment.
Furthermore, in order to ensure that the consumer
protection aspect is covered, the impact on
consumers’ information and choice needs to be taken
into account.
Recent debate has focused on the introduction of broader
socio-economic needs in addition to the three traditional
criteria when assessing biotechnologicallyderived
products. The debate is ongoing and the preoccupations
involved differ. To some, the concept includes a broader
analysis of health and environmental aspects. To others,
it should focus on social and/or economic impacts (for
example, consequences on agricultural production). The
Community must, above all, avoid a situation creating
uncertainty. As a rule, decisions have to be based upon
objective assessments using clearly identified criteria.
Uncertainties about product acceptance and authorization
could result in a diversion of investment and could act as
a disincentive for innovation and technological
development by industry. The Community must, however,
guarantee the public that human, animal, plant and
environmental health are being protected. The dynamism of
the industry and the confidence of public opinion depend
on the ability of the Community to reassure both parties.
Where a biotechnological product is assessed, the three
traditional criteria based on scientific evaluation apply.
By their nature, socio-economic aspects need to be
considered in a different way. It is not the intention to
have another systematic assessment in addition to the
three criteria. The Commission will normally follow
scientific advice. The Commission reserves the right,
however, to take a different view in the light of its
general obligation to take into account other Community
policies and objectives. This might, in exceptional cases,
lead to requirements for further information. It might
equally, in exceptional cases, lead the Commission to
propose that other policies be modified in the light of
biotechnological developments.”
The European Parliament establishes the framework laws
that govern the regulation of biotechnology in the member
countries, upon the recommendation of the Commission. For
example, there is a regulatory process for obtaining
approval to market novel foods.
European Group For Ethics in Science and New
Technologies
The group that deals with ethical issues for the European
Union is the European Group For Ethics in Science And New
Technologies (EGE). It was established by the EC in
December 1997. It superseded the Group of Advisors on The
Ethical Implications of Biotechnology, that had been
established in 1991. Notwithstanding its broader mandate,
that includes information technology and communications,
the new Group retains a major focus on biotechnology.
The ethical dimensions of biotechnology have been
progressively institutionalized within the EC throughout
the 1990s. The predecessor to the EGE played an important
role in advising the EC on the preparation and
implementation of EU legislation related to the regulation
of biotechnology. While ethical issues are not considered
within the regulatory process, they influence the
definition of that process through framework legislation.
The official mandate of the EGE is to “advise the
Commission on all ethical questions relating to science
and new technologies, either at the request of the
Commission or on its own initiative.” The Group has
twelve multidisciplinary members. They are appointed by
the Commission. Its deliberations are confidential.
However, every opinion of the Group must be published
immediately after its adoption. Where an opinion is not
adopted unanimously, it has to include competing or
dissenting views. The EGE can also issue opinions at the
request of the European Parliament or the Council of the
European Union. The EGE’s predecessor Group did not
have as broad a mandate. The change reflects the fact that
politicians asked to have direct contact with the Group,
due to the increasing interest of the European public and
the media in the ethical aspects of science and
technology.
Notwithstanding the confidentiality rule, the Group can
decide to hold public meetings on a topic. As well, the
Group may invite representatives of the EC, Institutions
of the European Union, experts, or other interested
parties, to attend its meetings.
The EGE is independent, and able to deliver its opinions
entirely free from outside influence. It differs from
national ethics committees in that its approach is
determined by the powers of the EC. These are more limited
than those of a Member State. On the basis of the
principles laid down in the European Treaties (that make
reference to the fundamental rights defined by the
European Convention of Human Rights – Council of
Europe), the EGE endeavours to draw up common rules to
enable the internal market to operate in accordance with
Europe’s ethical values.
The Group of Advisors on The Ethical Implications of
Biotechnology issued ten opinions from 1991 through 1997.
Two examples will serve to illustrate its impact on the
drafting of EC framework legislation concerning the
regulation of biotechnology.
Opinion No 3 The Legal Protection of
Biotechnological Inventions (30/09/93)
Opinion No 8 Ethical Aspects of Patenting
Inventions Involving Elements of Human Origin (25/09/96)
The Group issued extensive analyses and opinions in 1993
and 1996 on the subject of the ethical issues arising from
the patenting of biotechnology inventions. Among other
things, the Group saw no ethical grounds, in principle,
for opposing the patentability of inventions relating to
living matter, although it expressed the view that certain
types of genetic manipulation should be prohibited. The
Group recommended that human genes and partial gene
sequences whose functions are unknown should be made
expressly unpatentable. They also took a stand against the
commercial exploitation of the human body.
In July 1998, The European Parliament issued Directive
18/44/EC on the legal protection of biotechnology
inventions. The Directive states that account had been
taken of Opinion No 8 in developing the legislation. The
Group’s recommendations were adopted. In addition,
the Directive expresses the principle that
“inventions must be excluded from patentability
where their commercial exploitation offends against public
order or morality.” Examples provided are
interventions in the human germ line, the cloning of human
beings, uses of human embryos for industrial or commercial
purposes, processes for modifying the genetic identity of
animals that are likely to cause them suffering without
any substantial medical benefit to man or animal, and
animals resulting from such processes. Member States had
until July 20, 2000 to bring their domestic laws and
regulations into compliance with the EC Directive.
The passing of this legislation was the culmination of a
long and complex debate that spanned ten years. An initial
Directive was drafted by the EC in 1988.
Ethical concerns stopped the process. The Directive was
resubmitted in 1995, and it was rejected by the European
Parliament.
Opinion No 5 Ethical Aspects of the
Labelling of Foods Derived From Modern Biotechnology
(5/05/95)
This 1995 Opinion dealt with the issue of whether
genetically modified foods should be labelled. The Group
expressed the view that labelling is important where
genetic engineering causes a substantial change in
composition, nutritional value, or use for which the food
is intended. The labelling would include the new food
composition and characteristics, as well as the process.
However, if the composition and characteristics of the
food are unchanged, it would not be necessary to indicate
the nature of the process.
Regulation 97/258/EC of the European Parliament (May 15,
1997) lays down mandatory labelling for novel foods and
novel food ingredients, including those resulting from
genetic engineering. This includes genetically modified
organisms and their derivatives. The provisions on
labelling are tougher than those recommended by the Group
in its Opinion No 5. For example, the Regulation requires
that consumers be informed of differences between a new
product and existing equivalent products. This refers to
differences resulting from the use of biotechnological
processes, including the presence of live and/or processed
genetically modified organisms. Consumers’ rights in
the Member States include “a right to
information.” Labelling with respect to consumer
information is therefore seen as important, to give
consumers the opportunity to make an informed choice.
EC Consumer Committee
Another component of the EC infrastructure is the Consumer
Committee. It was established by the EC in 1995, as a
forum for general discussions on consumer concerns and
interests. As well, the Committee may be consulted by the
Commission on all problems related to the protection of
consumer interests at the Community level. The Committee
is chaired by the EC, which provides the secretariat.
There are twenty members, who represent national and
regional consumer organizations. A review of the
Committee’s recent opinions does not indicate any
focus on biotechnology-related issues. However, consumer
associations do provide views on framework legislation
related to the regulation of biotechnology. For example,
in 1997, the food industry, Member States, consumer
associations, environmental organizations and others
expressed their views to the EC on the introduction of
genetically modified foods and food ingredients onto the
European market.
The EC has also developed a Consumer Policy Action Plan
(1999-2001), that is intended to provide a more powerful
voice to the consumer throughout the European Union. Among
other things, consumer representatives will be given the
support they need to be effective in increasingly complex
technical debates.
Environmental Release of Genetically-Modified
Crops
In mid-1999, European Environment Ministers, bowing to
public opinion, toughened the policy (Directive 90/220/EU)
on releasing GMOs into the environment. Ministers declared
that the safety of organisms approved for release must be
reassessed after ten years, or earlier if one of the
Member States is concerned. States will have to monitor
the environmental impact of any releases. Ministers also
declared that the threshold level of genetically modified
ingredients at which products would have to be labelled
“genetically modified” should be decided on a
case-by-case basis. There are potential cost and
logistical implications, as a higher threshold requires
less stringent efforts.
These changes have to be considered by the European
Parliament. They are not expected to come into effect
until the end of 2001. Some Ministers were of the view
that the EU should not approve any releases in the
interim, until a new directive is issued. This de facto
moratorium has no legal status.
During 1999, no new approvals to market genetically
modified foods were granted in Europe. The anti-GM food
campaign that started in Britain and then spread to
elsewhere in Europe has changed the approaches of many of
Europe’s leading supermarket chains. Marks and
Spencer and Sainsburys created a pan- European consortium
of food retailers that plans to establish validated
sources of GMO-free crops, products and derivatives. The
consortium includes Carrefour and Supermarché
(France), Effelunga SA (Italy), Migros SA (Switzerland),
Delhaize Le Lion SA (Belgium), and Superquinn Ltd.
(Ireland). As well, major food groups have announced plans
to phase out the use of GM ingredients in some food
products (e.g. Gerber and Heinz).
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3.4 Denmark
Food Products and Crops
In Denmark, non-medical applications of biotechnology are
regulated under the Act on Environment and Genetic
Engineering (1991) and subsequent Statutory Orders.
Denmark, like other Member of the EU, has to comply with
the EC Directives on both the contained use and deliberate
release of genetically modified micro-organisms.
The Ministry of the Environment and Energy has the
responsibility of implementing the Danish legislation.
This is accomplished through its Environmental Protection
Agency.
Plants genetically modified in a laboratory to make them
more resistant to disease or pests must be approved by the
Agency before they can be released into the external
environment. Permits for experiments have been granted for
sugar beets and potatoes. The Agency also processes
permits to release genetically modified animals, which are
also being developed, and genetically modified
micro-organisms and micro-organisms in pesticides
(biopesticides).
In June 1998, the Danish Environmental Protection Agency
released its vision, challenges, and strategic directions
for the Year 2002. The section on biotechnology deals with
the Danish procedures for evaluating and approving GMOs.
There has been an increasing flow of applications for GMO
approvals, especially for plants. The biotechnology
challenge articulated by the Agency was the need to take a
decision on whether the procedures for evaluating and
approving GMOs could be organized to meet safety
requirements and, at the same time, simplified. Work was
also required to have the Danish model modified to be in
accord with the EC approval procedure.
The non-science aspect of the Agency’s
responsibilities arise from the fact that the Danish
public is unsure about the uses to which biotechnology can
be put - what is risky and what is straightforward. The
Danish EPA therefore intensified its communication to the
public on GMOs. The Agency also recognizes the need to
monitor GMOs and evaluate the long-term effects of their
use. However, there are no plans to change the regulatory
approval process in response to public concerns. De facto,
ethical issues related to GMOs are dealt with by the EU
framework legislation.
Medical Products
The medical applications of biotechnology fall under the
responsibility of the Ministry of Health. The Danish
Medicines Agency administers the legislation. Its
practices are similar to those in other jurisdictions.
Environment
Regulation related to environmental issues closely mirrors
that for crops. Trial releases and marketing of GMOs must
be approved by the Danish EPA. Procedures for evaluating
and approving GMOs address both environmental safety and
developmental potential. There is an increasing flow of
applications for GMO approval, especially for plants.
Aquaculture
The Act on Environment and Genetic Engineering (1991) and
subsequent Statutory Orders also applies to the
territorial waters and the fishery territory, as specified
under the Territorial Fisheries of the Kingdom of Denmark
Act. The Act also allows for the Danish Fisheries
Association and the Danish Sea Fisheries Association to
appeal decisions made by the Agency.
With regard to fisheries, the central task of the Danish
Environmental Protection Agency is to support the Ministry
of Food, Agriculture and Fisheries in setting out goals
and ensuring Denmark’s compliance with international
targets for an environmentally sound and sustainable
industry.
Danish Council of Ethics
The Danish Council of Ethics was created in 1987 to focus
on biomedical issues. Among other things, the Council:
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discusses general ethical issues in connection with
experiments on human subjects;
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advises health authorities on the assessment of general
ethical issues of major importance to the delivery of
health care, eg. relating to the use of new methods of
treatment and new diagnostic techniques;
-
informs the public on developments in biomedical
science and on the work of the Council;
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takes the initiative to make any ethical problems that
arise subject to public debate; and
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submits an annual report to the Minister of Health and
to Parliament.
The Council consists of seventeen members. Nine members
(including the chairperson) are designated by a
Parliamentary committee. The remaining eight members are
designated by the Minister of Health, taking into account
recommendations of the National Board of Health and the
Danish Health Research Council. The members are both
professional and lay persons. They must have a
“publicly substantiated knowledge of the ethical,
cultural and social questions of importance to the work of
the Council.” The Council can initiate work on its
own.
An interesting feature of the Council is its close linkage
with Parliament. At the beginning of each Parliamentary
year, and after general elections, Parliament appoints a
committee of nine members. It is this committee that
appoints the nine members to the Council. As well, the
Parliamentary Committee:
-
follows the work of the Council;
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participates in joint meetings with the Council; and
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can ask the Council to deal with any subjects that are
within the scope of the Council’s terms of
reference.
During 1996 and 1997, the topics considered by the Council
included assisted reproduction and prenatal diagnosis, the
patenting of biotechnological inventions,
xenotransplantation, and the cloning of human beings.
Their statement on cloning was used as the basis for a
Parliamentary debate. The Council also provided advice to
the EC on the drafting of legislation on the patenting of
biotechnological inventions. The Council does not have a
direct role in the regulatory approval process for
specific biotechnology products.
The Council has other features that are unique:
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it goes out of its way to have open public debates on
ethical issues, partly to gather different points of
view, and partly to educate the public;
-
in making its recommendations, it does not go out of
its way to establish a consensus on any given question,
since it holds the view that no clear-cut reply can be
given to ethical dilemmas; and
-
it does not assume the role of an expert body.
The Council’s education activities (1997) included
holding a creative writing competition on cloning, in
which 800 primary and secondary school pupils (grades
8-10) contributed short stories, poems, letters and essays
on their view of cloning. As a result of this and other
activities (eg. lectures, debating events), ethics has
worked its way firmly onto the agenda in the media, in
schools and in the cafeterias at Danish workplaces.
Another revealing aspect of the work of the Council is
that although it has been in operation for over ten years,
it has not developed a fixed set of ethical guidelines.
Rather, it has some basic working principles, such as no
harm, fairness and justice, human dignity, and the
protection of privacy. The Council’s view is that
nothing like a consensus exists on how to weigh these
principles against one another when faced with a specific
biomedical situation.
In 1997, the Council formed a working party to study when
and how, in a research project, ethics becomes an issue.
The rationale for this initiative is the widespread
perception that often, the ethical implications of new
techniques and procedures only get around to being
discussed once the technique has been tried, is ready for
use, and groups of patients and caregivers have acquired
an interest in it. The objective, therefore, is to
determine if ethical problem issues could be identified
and start to be considered earlier on. The Council dubbed
this project “ethics in time.”
Other Non-Science Issues
In a 1998 White Paper on Food Policy, the Danish
government stated its support for “satisfactory
labelling of products, which contain or are produced on
the basis of genetically modified organisms.” This
would include setting a low marginal value on how much
GMOs can be tolerated in GMO-free products before they
must be labelled.
In 1997, the Advisory Research Committee of the Ministry
of Food, Agriculture and Fisheries (ARCMF) was established
by the Minister. It provides advice to the Minister on
Ministry research and on the priority and choice of
research strategies, with particular regard to the quality
and industrial and social relevance of specific R&D
activities. The Committee consists of a chairperson and
eighteen nominated members that represent external
research organizations, industrial and social interests,
other users of research findings, and collaborating
bodies. ARCMF gives priority to the concepts of safety and
ethics in relation to foods manufactured with the help of
biotechnology.
To provide a scientific foundation for the safety
assessments undertaken in relation to the approval of
novel foods, the Committee took the initiative for a
fiveyear (1998-2002) program on biotechnology in food
research that incorporates these concepts. The program is
organized into four main areas:
-
food quality and safety in production and manufacture;
-
implementation and development of molecular-biological
methods and tools;
-
interactions between host and micro-organisms; and
-
social acceptance and ethics.
Danish Board of Technology
Mention should also be made of the Danish Board of
Technology (DBT). It was established by Parliament in 1995
as a permanent and independent institution. The DBT came
into existence in 1986, through the Technology Board Law.
The purpose of the 1995 legislation was to expand the
scope of its 1986 mandate.
The Board has a mandate to monitor technological
developments, carry out comprehensive assessments of the
potential benefits of technologies and their impacts, and
further public debate on these topics. The Board is also
mandated to advise Parliament and the Danish Government.
It has no direct role in the regulation of biotechnology,
but has debated regulatory issues.
The Board has eleven members. The Minister for Research
appoints the Chairman and three members. Other
institutions (eg. Danish Council for Adult Education)
appoint the remainder. In addition, about fifty persons
form a “ Board of Representatives,” that
serves as an open forum to debate technology assessment
subjects. Since 1987, the DBT has made use of
“consensus conferences and scenario workshops”
as means of assessing technologies for the Danish
Parliament.
The DBT has served as a mechanism to consider the impacts
of biotechnology. Some topics to date have been:
-
genetically modified foods (1999)
-
hearing of the Danish Parliament on genetically
modified plants (1996)
-
technological animals (1992)
-
how to apply the increased knowledge about human genes
(1989).
In March 1999, the DBT held a consensus conference on
genetically modified foods. The backdrop was the
public’s continued scepticism about such foods, that
are gaining ground on the shelves of Danish supermarkets.
The DBT gathered a panel of fourteen citizens and asked
them to consider the subject. The citizens invited a group
of thirteen experts to assist them. The panel produced a
report containing their evaluations and recommendations.
The objective of the conference was to strengthen the
dialogue between the public and decision-makers. The final
report contains a number of recommendations that relate to
the regulatory process for biotechnology. They reflect the
deep public concern about the safety and environmental
impacts of genetically modified foods. For example:
-
The panel recommended that authorizations for tests and
production of genetically-modified organisms should be
the subject of stringent regulations for risk
evaluation and requirements for efficient control.
-
In the panel’s view, it is important to preserve
the biodiversity of plants and animals and protect
natural ecosystems. Ethical considerations of
interference with individual plants or animals must be
seen in an overall framework, taking into account the
entire living nature and its integrity.
-
The panel recommended the establishment of a committee
charged with ensuring an ethical evaluation of the
authorisation process. The panel recommended that
ethical aspects be given the same priority as purely
technical aspects in relation to applications for
testing, production and marketing of genetically
modified foods.
-
3.5 Britain
Food Products
The principal legislative instruments for the control of
food safety and standards in Britain are the Food Safety
Act 1990 and the Food Standards Act 1999. In addition, a
large body of food legislation has been developed by the
European Union. It is either directly applicable in
national law or has been implemented under the Food
Safety Act.
Prior to April 2000, responsibility for the development
and implementation of food safety and standards policy
rested with the Ministry of Agriculture, Fisheries and
Food, and the Department of Health. A new department was
created - the Food Standards Agency. It operates at
arm’s length from Ministers and is accountable to
Parliament through the Health Minister.
The general functions of the Agency are to:
-
develop policies on food safety, food standards and
other related matters, and to provide advice,
information, and assistance to enforcement authorities;
-
provide advice and information to the general public on
matters connected with food safety, food standards and
nutrition;
-
monitor developments in science and technology and
other fields related to food safety and standards
development, and commission research; and
-
set and monitor enforcement standards and audit the
local authority application of these in the UK.
Risk assessment is carried out by the advisory committees
of independent experts that provide advice to the Agency.
The Advisory Committee on Novel Foods and Processes
(ACNFP) is one of those committees. Its main task is to
consider requests from the food industry and others for
clearances of novel foods and processes.
Medical Products
The UK Medicines Control Agency is an executive agency of
the Department of Health. Its primary objective is to
safeguard public health by ensuring that all medicines on
the UK market meet appropriate standards of safety,
quality and efficacy. The Agency consults the Committee on
Safety of Medicines (CSM) on marketing authorizations for
new products.
Crops
GM crops undergo three phases of testing:
-
laboratory and greenhouse tests to ensure that the
plants are what they are supposed to be and do what
they are supposed to do;
-
initial small-scale field trials that test the
performance of the GM plants under field conditions and
monitor any impact on human health and the environment
(this includes, for example, impacts on other species,
insects), in accordance with the safety tests laid out
by the Advisory Committee on Releases to the
Environment (ACRE); and
-
farm scale evaluations, to determine what impact, if
any, the management of the GM crop will have on the
environment and biodiversity. In the future,
applications for new GM crops will have to include a
comprehensive environmental impact study, before they
can be considered for a commercial licence.
Environment
The Advisory Committee on Releases Into The Environment
(ACRE) is an independent statutory body of experts under
the Environmental Protection Act 1990. It considers
regulatory approvals for the release of genetically
modified organisms (plants, including agricultural ones
and animals) into the environment.
Advisory Committee System and Non-Science
Issues
Britain has had an elaborate system of advisory
committees. Prior to May 1999, this consisted of eight
committees that were biotechnology-specific, and nine
others that were not specifically for biotechnology but
have biotechnology as a component of their work.
These bodies were created over time to address new issues
as the need arose. Questions were raised as to the
continued appropriateness of the system, given the speed
at which new technologies are being developed, and the
fact that both the public interest in, and concern about,
some aspects of biotechnology were increasing.
In December, 1998, the British Government, through the
Ministerial Group on Biotechnology and Genetic
Modifications, announced a review of the biotechnology
advisory committee framework. Among the specific issues
examined were:
-
how could the system for providing advice to Government
be made more transparent?
-
are ethical and other wider issues addressed fully and
properly in the system?
-
are stakeholders given appropriate opportunities to
make their views known?
-
is the framework flexible enough to cope with the rapid
development of the technology that is likely in the
future?
-
does the public have confidence in the system currently
in place?
In addition to the committees mentioned above, the main
biotechnology advisory committees that were in place at
the time the review was launched are outlined below. None
of these approves products or processes, but could be
faced with non-science issues. This is followed by the
changes to the system that were announced by the
government on May 21, 1999.
Advisory Committee on Genetic Testing
(ACGT)
This is a non-statutory body established in 1996 that
advises the Health Minister on developments in genetic
testing, taking into account ethical, social, and
scientific aspects. It establishes requirements,
especially with respect to efficacy and product
information, to be met by manufacturers and suppliers of
genetic tests.
Advisory Committee on Genetic Modification
(ACGM)
This is a non-statutory body that advises the Health and
Safety Commission/Executive and the Minister on all
aspects of human and environmental safety arising from the
contained use of GMOs. ACGM focuses on safety questions in
the laboratory and industrial installations. It is not
involved in product approval.
Human Genetics Advisory Commission (HGAC)
This is a non-statutory body that reports to Industry and
Health Ministers on issues arising from new developments
in human genetics that can be expected to have wider
social, ethical, and/or economic consequences. It
maintains under review scientific progress at the
frontiers of human genetics and related fields. It also
advises on ways to build public confidence in, and
understanding of, these subjects. The Commission started
work in 1997.
Advisory Group on Scientific Advances in Genetics
(AGSAG)
This Group provides advice on the implications foe public
health and the National Health Service of advances in
genetics.
New Framework For Overseeing Developments in
Biotechnology
The main concerns that emerged from the government’s
review relate to the treatment of non-science issues,
broader environmental issues, and the challenge of
anticipating developments in biotechnology:
-
Regulatory and advisory arrangements are of necessity
complex and are difficult for the public to understand.
-
They do not properly reflect the broader ethical and
environmental questions and views of potential
stakeholders.
-
They are not sufficiently forward-looking for so
rapidly developing a technology.
The government concluded that the regulatory and
advisory framework has two functions, and that the
second required a new approach:
-
to consider whether to grant approvals for individual
products and processes: and
-
to set a strategic framework for development of the
technology in the UK.
The decision was taken to establish a
“strategic” advisory structure. Two new
biotechnology-specific bodies were established:
-
the Human Genetics Commission (HGC), to advise on
genetic technologies and their impact on humans; and
-
the Agriculture and Environment Biotechnology
Commission (AEBC), to advise on all other aspects of
biotechnology, except food.
The two new commissions will keep in close touch with the
work of the regulatory system, but will not control the
work of individual committees. The members of the
commissions act in a personal capacity, but are drawn from
a wide range of interests and expert disciplines. They
will consult the public and stakeholders in carrying out
their work.
The Human Genetics Commission (HGC) reports jointly to the
Health and Science Ministers. Because of the broad scope
of its mandate, the Agriculture and Environment
Biotechnology Commission (AEBC) will report directly to
the Minister for the Cabinet Office, who is Chairman of
the Cabinet Committee on Biotechnology and Genetic
Modification.
As part of streamlining the advisory committee structure,
three existing committees were wound up, and their
responsibilities passed to the new Human Genetics
Commission. These are the Advisory Committee on Genetic
Testing, the Advisory Group on Scientific Advances in
Genetics, and the Human Genetics Advisory Commission.
The Terms of Reference of the new Human Genetics
Commission (HGC) is typical of how the other commission
will operate. There is explicit provision for the
consideration of non-science issues. The mandate of the
HGC includes:
-
analyzing current and potential developments in human
genetics and advise Ministers on their likely impact on
human health and health care, as well as on their
social, ethical, legal, and economic implications;
-
advising on strategic priorities for research;
-
developing and implementing a strategy to involve and
consult the public and other stakeholders, encourage
debate on the development and use of human genetic
technologies, and advising on ways of increasing public
knowledge and understanding;
-
identifying and advising on the effectiveness of
existing guidance and of the regulatory and advisory
framework as a whole, taking into account European and
global dimensions;
-
looking at the lessons learned from individual
regulatory cases, to construct a wider picture; and
-
considering specific issues related to human genetics
as requested by Ministers.
-
3.6 France
Food Products
There are two key bodies in France that regulate
genetically modified plants, animals, and micro-organisms:
Each of these bodies bases its evaluation only on
scientific factors. The Commission du Génie
Biomoléculaire has eighteen members. They are
appointed by the two Ministers. Eleven are scientific
experts in genetic engineering. Other members are from
sector interest groups – e.g. consumers,
environment, agricultural production. The Chairperson of
the Commission is from the Ministry of Agriculture and
Fisheries. Officials of the Health Ministry attend the
Commission’s meetings.
A government regulation of February 1997 requires the
labelling of all foods composed partially or entirely of
GMOs.
Medical Products
Medical products and genetic therapies based on
biotechnology are regulated by l’Agence
Française de sécurité sanitaire des
produits de santé (AFSSAPS). This agency was
created in July 1998 and has a broader mandate than the
Agence du médicament, the agency it superseded. It
does not consider non-science issues in its regulatory
decision-making processes.
Crops
The Commission of Biomolecular Genetics undertakes
biosafety reviews (and food safety reviews) and advises
the Minister of Agriculture, the Permanent Technical
Committee of the Selection of Plant Cultivars, and the
Minister of the Environment. It operates within the
context of EU regulations. Its mandate is to:
-
provide an opinion at the R&D level, on the
potential risks (toxic, allergenic, ecological,
economic) related to the release of GMOs in the
environment;
-
provide an opinion on the authorization for placing
GMOs on the market; and
-
propose research that should be done on the impacts of
the environmental release of GMOs, particularly with
respect to transgenic plants.
Evaluations are conducted based solely on scientific
factors. France emphasizes the “risk” of
genetic imprecision and requires that GMOs be precisely
constructed in order to minimize environmental
uncertainty.
Environment
The Commission of Biomolecular Genetics undertakes
biosafety reviews and advises the Minister of the
Environment. The Commission operates within the context of
EU regulations and its evaluations are conducted based
solely on scientific factors.
The precautionary principle is used in every case. This
means:
-
preventing the GMO from spreading into the environment;
-
ensuring that the GMO presents no environmental or
health risks;
-
including a period of surveillance of the GMO with the
option of pulling it off the market (as in the US);
-
studying the GMO over a long period of time; and
-
labelling if the GMO is not equivalent to a traditional
food.
Aquaculture
The Minister of Agriculture and Fisheries is responsible
for aquaculture, which is under the regulatory
jurisdiction of the Commission on Biomolecular Genetics.
National Consultative Ethics Committee for Health
and Life Sciences (Comité consultatif national
d’éthique pour les sciences de la vie et de
la santé – CCNE)
The National Consultative Ethics Committee for Health and
Life Sciences was established by a decree signed by the
President of France in February 1983. It was enacted in
law in 1994. The Committee’s mission is to give
opinions on ethical problems raised by progress in the
fields of biology, medicine, and health. Its
recommendations are published. It is an independent body,
linked to the Ministers of Research and Health.
The Committee is composed as follows: the President,
nominated by the President of the Republic, an Honorary
President, and 39 members. Five of these members are drawn
from the main philosophies and religious faiths and are
designated by the President of the Republic. Nineteen
members are chosen because of their qualifications,
competence, and their interest in ethical issues. Fifteen
members are engaged in scientific research.
The Committee is a purely consultative body, and it may be
tasked by Assemblies, members of the Government, an
establishment of higher education, a public institution,
or an officially recognized foundation whose main activity
is research, technological development, or the promotion
and protection of health. The Committee can also initiate
work on matters raised by persons other than those listed
above, or by one of its own members.
Each issue is investigated by a working group composed of
members of the Committee, who may request help from
outside experts. The issue is examined by a group of
technical experts, who then decide on its examination by
the Committee in plenary session. A final report is
drafted and more often than not, opinions and
recommendations are appended.
The Committee makes the results of its work known in the
following ways:
-
an annual public conference is organized on ethical
problems in the fields of health and life sciences;
-
press conferences are held when the Committee adopts an
Opinion;
-
a quarterly review called Les Cahiers du Comité
publishes the full text of the Committee’s
opinions, recommendations and reports.
The Committee does not engage directly in the review of
protocols for the protection of persons in the context of
biomedical research. However, it is involved in questions
concerning biomedical research. For example, the Committee
has released eight opinions and two publications regarding
the use of human beings in biomedical research settings,
for the benefit of ethics review committees that review
research protocols.
Since 1984, the Committee has issued about sixty-one
opinions, on a wide variety of subjects. Many are related
to biotechnology. One opinion re-examined the laws on
bioethics. The Committee has also published numerous
reports (eg. Genetics and Medicine – From Prediction
to Prevention, Paris 1997). The Committee is of the view
that Parliament could have done more over the years to
transform its opinions into legislation.
Role of Consumer Groups
Consumers groups can make their views on genetically
modified foods known through the Conseil national de
l’alimentation. The Conseil was established by the
government in 1985. It provides a forum for discussion and
seeks advice on nutrition, food security, food quality,
and consumer information. Its members are from the
agrifood industry, consumer groups and include scientists
and government administrators. The Secretariat is provided
by the Ministry of Agriculture and Fisheries.
The Conseil provides formal opinions to the government.
Opinion number 17 is on the labelling of foods containing,
or derived from, GMOs.
-
3.7 Norway
The use of biotechnology in Norway is regulated by two
acts – The Gene Technology Act and the Act Relating
To The Application of Biotechnology in Medicine. Both Acts
reflect strong ethical considerations, as well as a
significant degree of conservatism. They establish the
policy framework for the regulation of the products of
biotechnology.
Food Products
The Gene Technology Act (April 1993) regulates
all production and use of genetically modified organisms
(excluding humans). The Act covers both the contained use
and deliberate release of GMOs. Contained use includes the
production and use of GMOs to be marketed or put into
other commercial use. Deliberate release includes the
placing on the market of a product consisting of, or
containing, genetically modified organisms.
Approval is not required for a product to be placed on the
market that has been approved in another European Economic
Area (EEA) country. The Agreement on the EEA was signed in
1992 between the EC, the then twelve EU Member States and
the seven EFTA States (Norway, Austria, Finland, Iceland,
Liechtenstein, Sweden, Switzerland). Switzerland
subsequently backed out and in 1995, Austria, Finland and
Sweden joined the EU. The EEA Agreement came into force in
1994.
Regulations regarding deliberate release, risk management
and marketing were implemented in 1993. Regulations on
contained use came into force in 1994. As regards
contained use, Norway has included higher organisms in the
regulations. Not only GMOs are regulated, but also plants
and animals for contained use. Norway follows EC
directives for the contained use of micro-organisms and
their introduction into the environment.
In June 1997, in response to public concern, Parliament
voted that all genetically modified food must be labelled,
including foods containing modified ingredients, if they
contain 2% or more of GMOs. In addition, a ban was placed
on all genetically modified products that might cause
resistance to antibiotics, etc.
Medical Products
The second piece of legislation that governs the
regulation of biotechnology is the Act Relating to The
Application of Biotechnology in Medicine (1994). It covers
such matters as assisted reproductive technology, genetic
testing after birth, and gene therapy. The Act deals
primarily with the application of biotechnology through
techniques and products. In its preamble, the Act
specifies the principles of “respect for human
dignity, human rights and personal integrity.” It
bans research on embryos. As well, there is a provision
that genetic testing of a child under sixteen years of age
cannot be carried out unless the test is able to detect a
condition that by means of treatment can prevent or reduce
damage to the child’s health. This latter provision
has the effect of limiting the application of diagnostics
in the market.
Crops
The Ministry of the Environment regulates the use of
biotechnology in crops. The Directorate for Nature
Management undertakes expert assessments regarding
genetically modified higher plants and animals, while the
State Pollution Control Authority undertakes similar
assessments for genetically modified micro-organisms.
Regulation falls under the Gene Technology Act, which
entered into force in 1993. The purpose of the Act is to
ensure that the production and use of genetically modified
organisms takes place in an ethically and socially
justifiable way, in accordance with the principle of
sustainable development, and without detrimental effects
to health and the environment. Contained use includes the
production and use of GMOs to be marketed or put into
other commercial use. Deliberate release includes the
placing on the market of a product consisting of, or
containing, GMOs.
Environment
The Ministry of Environment, Section for Biodiversity and
Biotechnology, is responsible for environmentally sound
management of biotechnology. According to the Gene
Technology Act:
Deliberate release of genetically modified organisms may
only be approved when there is no risk of detrimental
effects on health or the environment. In deciding whether
or not to grant the application, significant emphasis
shall also be placed on whether the deliberate release
represents a benefit to the community and a contribution
to sustainable development.
A regulation on impact assessment in the Gene
Technology Act has been adopted. Guidelines on the
procedure concerning applications for deliberate release
of GMOs referred to in the Gene Technology Act have also
been established. An amendment to the Norwegian Gene
Technology Act of 1993 was adopted in June 1995. This
makes it possible for Norwegian authorities to issue
specific regulations with regard to the export of GMOs and
for the establishment of Norwegian industries abroad for
the production of such GMOs. The deliberate release of
GMOs is subject to approval by the Ministry of
Environment.
As part of the EEA-agreement (European Economic Area)
between EFTA (European Free-Trade Area) and the EU, Norway
has implemented the Directive 90/220/EC on the deliberate
release into the environment of genetically modified
organisms. Approval is not required for a product to be
placed on the market if it has been approved in another
EEA country.
Aquaculture
The use of GMOs in aquaculture facilities is covered under
the Gene Technology Act, and is subject to approval
according to its requirements.
Non-Science Issues
The Gene Technology Act states that the King may
issue regulations concerning the marking of products that
consist of, or contain, GMOs.
In June 1997, in response to public concern, Parliament
voted that all genetically modified food must be labelled,
included foods containing modified ingredients, if they
contain 2 per cent or more of GMOs. In addition, a ban was
placed on all genetically modified products that might
cause resistance to antibiotics.
During the Codex Alimentarius, Codex Committee on Food
labelling (CCFL) meeting held in Ottawa in May 2000,
Norway called for mandatory labelling of all foods derived
from biotechnology, without qualification. Norway’s
pre-conference comments stated:
We are of the opinion that all foods genetically
modified or genetically engineered, for whatever
purpose, should be labelled as such, regardless of
having been changed or not.
The main issue for the consumer is not whether a product
can have an effect on human health under different
circumstances or is different from a
"conventional" product, but rather the
consumer’s right to being properly informed. Thus,
in a field where concerns exist based, e.g. on ethical and
environmental values, they would be able to make their own
choice . . . Consumers have a right to have their views in
this regard acknowledged by the authorities.
Ethical considerations are strongly reflected in the
regulation of biotechnology in Norway. For example, the
Gene Technology Act states that:
In cases where approval is required under the present Act,
the competent authority may decide that a public
consultation is to be carried out. Such consultation shall
take place in good time before the decision on the case is
made. The decision to carry out a public consultation
shall be publicly announced.
Furthermore, the Act prohibits the altering of an
animal’s genetic material with the aid of gene
technology if:
-
this makes the animal unable to carry out normal
behaviours or affects physiological functions in an
undesirable way;
-
the animal is made to undergo unnecessary suffering; or
-
the alterations provoke general ethical reactions.
Norwegian Biotechnology Advisory Board
The consideration of ethical issues in Norway have been
institutionalized through the Norwegian Biotechnology
Advisory Board. The Board consists of experts in the
natural sciences, law, philosophy, representatives of
environmental groups, farmers’ associations, trade
unions, etc. They are appointed by the government. The
mandate of the Board is to:
-
maintain an awareness of current issues in
biotechnology, as it is applied to humans, animals and
plants;
-
evaluate fundamental or general issues regarding
biotechnology, including ethical and social
considerations;
-
discuss ethical principles and their application to
biotechnology activity, and issue proposals for ethics
guidelines;
-
comment on proposed legislation;
-
comment on matters associated with existing legislation
on the creation and use of genetically modified
organisms and on the use of genetic technology on
humans;
-
make recommendations concerning applications for
approval of contained use and deliberate release, and
the work of the Appeals Board in connection with
rejected applications (however, the Board does not have
the power to veto approvals);
-
disseminate information and contribute to communication
with government, scientists and lobby groups; and
-
advise Norwegian Government organizations on
Norway’s position in international fora on the
subject of biotechnology.
The Board has issued reports on subjects such as:
-
the use of fetal tissue
-
genetic technologies and agricultural production
-
genetic testing – when and why?
-
genetically modified foods
-
biotechnology in aquaculture
-
genetic technologies – a ten year view
-
genetic technology and industry.
Both the Gene Technology Act and the Application
of Biotechnology in Medicine Act contain a provision for
the Government to consult the Norwegian Biotechnology
Advisory Board. The Board is able to “express its
views on matters covered by the Acts and on other
questions concerning biotechnology, on request or ex
officio.” It can be consulted at any time when
specific products are being considered by regulators. The
Board’s opinions are public.
Both pieces of legislation governing the regulation of
biotechnology were commented upon extensively by the
Norwegian Biotechnology Board.
-
3.8 Australia
Since 1975, biotechnology, except for that related to
humans, has been the subject of voluntary assessment in
Australia. The development and use of genetic manipulation
techniques has been overseen by the non-statutory Genetic
Manipulation Advisory Committee (GMAC). Stakeholders have
voluntarily complied with the GMAC’s guidelines and
recommendations.
Historically, the regulatory system has been strongly
science-based, with little consideration given to
non-science issues. This has been the case, in part,
because most of the GMOs that have been the subject of
regulation have been contained.
The description below of the regulatory system that has
been in place is followed by a summary of how that system
is being changed through far-reaching legislation that was
introduced in June 2000. The new legislation makes
explicit provision for the consideration of non-science
issues.
Food Products
Food, including GM food, has been regulated under State
and Territory Food Acts. The role of developing food
standards has rested with the Australia New Zealand Food
Authority (ANZFA), under the Australia New Zealand
Food Authority Act 1991. ANFZA develops food
standards for recommendation to the Australia New Zealand
Food Standards Council (ANZFSC), which is made up of
Commonwealth, State, Territory, and New Zealand Health
Ministers. To regulate food produced using gene
technology, ANZFSC has approved Standard A18. The Standard
requires that all foods derived from a GMO are assessed as
safe, prior to being allowed on the market. Safety
assessments of GM foods are open to public comment at
various stages of inquiry and if any significant doubt
exists, ANZFA will not recommend their approval.
The socio-economic context in which the regulatory
frameworks are positioned are set by the Commonwealth
Government. Food standards must focus on objectives set
out in the ANZFA Act (section II). If, after a thorough
examination of the evidence, it is considered that a
regulatory measure is required, a regulatory impact
assessment is undertaken to determine the regulatory
option that would most effectively achieve the objective.
These assessments consider wider issues such as the impact
of regulation on food availability, cost, quality,
consumer choice, and other social costs.
Medical Products
Therapeutic products are regulated under the
Therapeutic Goods Act (1989), which is
administered by the Therapeutic Goods Administration
(TGA). The legislation regulates the import, manufacture
and supply of all therapeutic products. Unlike ANZFA, TGA
approves individual products. Genetically engineered
therapeutics are assessed for quality, safety, efficacy,
and timely availability.
Crops
The Genetic Manipulation Advisory Committee (GMAC) has
overseen the release of GMOs into the open environment,
such as field trials and the commercial growing of GM
crops. As of February 2000, GMAC had assessed:
-
5164 proposals for small scale contained work
-
40 proposals for large scale contained work
-
236 proposals for field trials of GMOs (mainly for
genetically modified plants)
-
8 applications for commercial release of GMOs (3 have
been approved to August 2000).
Criticism of the current regulatory system has focused
mainly on the perceived lack of transparency in
GMAC’s decision-making process and its apparent
incapacity to ensure that conditions placed on field
trials are strictly complied with.
Environment
The Environment Protection and Biodiversity
Conservation Act 1999 (EPBC Act) currently provides
that actions that are likely to have a significant impact
on one of the defined matters of national environmental
significance (e.g. nationally threatened species) requires
approval from the Minister for the Environment and
Heritage. An application dealing with a GMO that is likely
to significantly impact on a matter of national
environmental significance will continue to be subject to
relevant provisions of the EPBC Act. The proposed
amendments recognise that the EPBC Act will apply of its
own force to such GMO cases. A single assessment process
will be conducted which examines both the relevant impacts
on matters of national environmental significance and, to
enable the Environment Minister to provide advice to the
Gene Technology Regulator, on the risks that the GMO
dealing poses to the environment generally.
In terms of specifics, a proposal for an intentional
release to the environment will, under the Gene
Technology Act, require an extensive consultation
process requiring input from the Environment Minister,
States, local government, and the community, prior to
issuing a licence. Intentional release includes all
commercial releases of a GMO, including viruses and
bacteria, and field trials of GM crops and animals, even
if such trials include measures for limiting the spread of
the GMO.
As a first step, the Regulator must determine whether the
proposed release is one that may pose a significant risk
to the environment or human health and safety. A number of
criteria are specified that the Regulator must consider in
forming an opinion. If the Regulator concludes that there
may be a significant risk, including the potential for the
spread of the GMO, submissions must be invited from the
public on whether the licence should be issued. The
submissions must identify the risks and the means of
managing them.
Whether or not there is a significant risk, the Regulator
must prepare a risk assessment and a risk management plan.
In preparing the plan, the Regulator must consult the
States, the GTTAC, the Environment Minister, and any
Commonwealth authorities or agencies prescribed in the
regulations. The Regulator must also consult any local
councils considered to be appropriate.
The Regulator must take into account any advice provided
by these bodies, as well as any advice given by the public
in written submissions. After preparing a risk assessment
and risk management plan, the Regulator must invite
written submissions from the public on those documents,
and also seek advice from the States, the GTTAC, the
Environment Minister, and any Commonwealth authorities and
agencies prescribed in the regulations.
The Regulator has the discretion to take other action,
such as holding public hearings. It is important to note
that although the Regulator is required to take into
account the advice given by persons and bodies, he or she
is not obliged to follow the advice given by any of them.
The ultimate decision on whether to grant a licence and
under what conditions remains with the Regulator.
Aquaculture
The breeding of GM animals, including fish has been a gap
under the current regulatory system. They will be
regulated by the Gene Technology Regulator under the
Gene Technology Act 2000.
Gene Technology Act 2000 – Treatment of
Non-Science Issues
Three developments have driven the need for change in
Australia’s regulation of biotechnology:
-
the development of GMOs that do not fall within the
mandates of existing regulators, such as GM crops, GM
animals or fish, and GM micro-organisms for use in
bioremediation;
-
the move towards more commercial releases; and
-
increased expectations on the part of the public and
industry for a more transparent regulatory system.
The governance system under the new Act, including the
role of non-science issues, provides an interesting model.
It is therefore explained in some detail below.
With the Gene Technology Act in force, the
current regulatory regime for therapeutic products and
food containing GMOs or GMO products will continue. The
purpose of the Act is to regulate dealings with GMOs and
not GM products, unless they are not regulated under the
existing regulatory regimes. However, the informal role of
GMAC in providing advice will be formalized, by conferring
it on the Gene Technology Regulator (GTR).
The Gene Technology Regulator is an independent statutory
office holder and is not subject to direction from anyone
in relation to the performance of his or her functions.
This includes whether or not to grant a GMO licence, with
or without conditions. The Regulator is appointed by the
Governor General, with the approval of the majority of
jurisdictions.
The functions of the Regulator include:
-
determining applications for GM licences;
-
developing draft policy principles and policy
guidelines to be issued by the Ministerial Council;
-
developing codes of practice, technical, and procedural
guidelines in relation to GMOs;
-
providing advice and information to other regulatory
agencies and to the public;
-
undertaking or commissioning research in relation to
risk assessment and biosafety of GMOs; and
-
promoting the harmonization of risk assessment relating
to GMOs and GM products by regulatory agencies.
The Regulator may delegate any of his or her powers or
functions to an employee of the Department of Health or
Aged Care, or an employee of another Commonwealth
Department, authority or State agency, whose functions
relate to GMOs and GM products. This enables the Regulator
to delegate to a relevant agency, such as ANZFA.
The Regulator’s function is to focus on risks to the
environment and to human health and safety. Economic and
trade issues are not part of that function.
The Regulator is bound by policy principles issued by the
Ministerial Council. A licence cannot be issued if doing
so would be inconsistent with a policy principle. The
Ministerial Council established under the Act consists of
one or more Ministers from the Commonwealth and each
participating State and Territory. The role of the Council
is to oversee the operation of the Regulator, and to
consult on, and issue, policy principles and policy
guidelines to advise the Regulator on codes of practice
and standards for persons conducting dealings with GMOs.
Policy principles are disallowable instruments that deal
with ethical issues related to GMOs or other matters
prescribed by regulation. They are issued by the
Ministerial Council after consultation with a number of
Commonwealth, State, industry, and community
organizations, including the three Commonwealth advisory
committees established under the Act (see below).
Policy guidelines can also be issued by the Ministerial
Council. They deal with matters relevant to the
Regulator’s functions. The Regulator must have
regard to policy guidelines in deciding whether to issue a
GMO licence, but is not bound to follow them. Unlike
policy principles, policy guidelines do not have to be
formulated in consultation with anyone, although the
Ministerial Council may choose to consult.
The Regulator has the ability to obtain scientific,
ethics, and other advice from three advisory committees
established by the Act.
The Gene Technology Technical Advisory Committee (GTTAC)
will be composed of up to twenty scientific and technical
experts and one lay person. It will replace the current
GMAC. Its function is to provide scientific and technical
advice on gene technology, GMOs, and GM products,
including the biosafety aspects of gene technology.
The Gene Technology Community Consultative Group (GTCCG)
will be composed of up to twelve persons, mainly
representatives of a range of sectors of the community
(including the environment, public health, primary
industry, local government, and consumers). Its function
is to provide advice on matters of general concern
regarding GMOs.
The Gene Technology Ethics Committee (GTEC) provides
advice on ethical issues related to gene technology. It
will be composed of up to twelve persons with expertise in
ethics, religion, and law. The GTEC will have one member
from the GTTAC, and one member of the Australian Health
Ethics Committee with expertise in medical research.
All members of these three committees are appointed by the
Minister, after consultation with the States, the
Regulator, scientific, health, environmental and industry
groups, and other Ministers as appropriate. All members
hold part-time paid appointments, and will be subject to
conflict of interest guidelines.
The Regulator has the ability to obtain science, ethics,
and other advice from the three advisory committees
established by the Act. Only the GTTAC will be involved
directly in providing advice on GMO licences and other
applications. The GTCCG and the GTEC will be consulted
only in relation to general principles or guidelines, and
not in relation to specific decisions. All three
committees may be consulted regarding the need for, and
content, of policy principles to guide the ethics-related
decisions of the Regulator, as well as codes of practice
applicable generally to dealings with GMOs. However, only
the GTTAC and the CTCCG may be consulted on the need for,
and content of, policy guidelines and technical or other
specific guidelines relating to GMOs and GM products. The
GTEC does not have a function to advise on policy
guidelines or specific guidelines.
-
3.9 New Zealand
In April 2000, the Minister For The Environment announced
the establishment of a Royal Commission on Genetic
Modification. Public hearings began in September 2000 and
will end in March 2001. The Royal Commission has been
appointed to receive representations on, inquire into, and
report on:
-
the strategic options available to enable New Zealand
to address genetic modification, genetically modified
organisms and products, now and in the future; and
-
any changes considered desirable to the current
legislative, regulatory, policy, or institutional
arrangements for addressing genetic modification, and
genetically modified organisms and products in New
Zealand.
It was the intent of the government to negotiate, with
industry and research groups, a voluntary moratorium on
the release of GMOs during the life of the Royal
Commission. This moratorium also applies to the field
testing of GMOs, with some limited exemptions.
Food
New Zealand has a joint food standards system with
Australia that covers GM foods. The role of developing
Food Standards rests with the Australia New Zealand Food
Authority under the Australia New Zealand Food
Authority Act 1991 (ANZFA). ANZFA’s objectives
include protecting public health and safety, and providing
information to consumers.
ANFZA develops food Standards for recommendation to the
Australia New Zealand Food Standards Council (ANZFSC),
that is made up of Commonwealth, State, Territory and New
Zealand Health Ministers. To regulate food produced using
gene technology, ANZFSC has approved Standard A18, which
requires it to be safety assessed by ANZFA. It also
requires such food to be labelled if it is “not
substantially equivalent” to its conventional
counterparts and it contains new or altered genetic
material.
The standard prohibits the sale of GM foods, unless they
have been assessed by ANZFA and approved as suitable for
sale by the Australia New Zealand Food Standards Council
(ANZFSC). When a specific GM food has been approved by
ANZFSC, it is listed in the standard. The ANZFA process
for assessing the safety of a GM food is open and
consultative. If ANZFA has any doubts about the safety of
a GM food, it will not be allowed on the market.
The food standard also specifies the circumstances when
specific labelling is required. Currently, Standard A18
under ANZFA requires that all products containing GM
commodities, that are not “substantially
equivalent,” must be labelled to inform consumers of
that fact. This refers to GM foods that are the same as
their conventional counterparts in nutrition,
allergenicity, toxicity or other physical properties.
In October 1999, the Ministerial Council resolved to adopt
mandatory labelling of all GM foods, not just those that
are substantially different as required in the existing
standard. This was done for consumer information purposes.
In July 2000, the Council agreed to label GM foods where
they are present in the final food, or if the food has
altered characteristics. The Standard allows an ingredient
to contain up to one per cent of unintended presence of
genetically modified product.
Medical Products
Applications for classification of medicines are made to
the Ministry of Health under the Medicines Act. Medicines
that also have hazardous qualities need to be approved
separately by ERMA. There may also be applications for
approval for new organisms (including genetically modified
organisms) in this category. There are no border controls
for medicines except for narcotic and psychotropic
medicines regulated under the Misuse of Drugs Act, where
an import licence is required. Although most medicines
require ministerial approval before they can be
distributed (but not imported), some do not. Typical
examples of medicines that do not require approval are
those used for:
-
clinical trials (the trial needs approval but the
medicine doesn't);
-
compassionate use (doctors have some discretion in
importing medicines, which would otherwise require
approval, for particular patients); and
-
natural health, where a natural health practitioner (or
any other person) may import unscheduled medicines.
The HSNO Act brings two amendments to the Medicines Act:
-
the Minister of Health must give written notification
to ERMA of any consents for distribution of a medicine
in accordance with the Medicines Act; and
-
where there is any inconsistency between the HSNO Act
and the Medicines Act with respect to a medicine that
is also a hazardous substance, the Medicines
Act will prevail.
Crops
ERMA and the HSNO regulate crops in New Zealand. ERMA
oversees the development of genetically engineered plants
in New Zealand, their initial fieldtesting at contained
sites, and their subsequent general release for
agricultural purposes. It also covers the importation of
genetically engineered cultivars into New Zealand and the
importation of plant material intended for food
consumption that contains viable propagules that could be
grown (e.g. fruits and seeds).
All applications for the release of genetically engineered
crops are the subject of public notification and a
six-week period for public comment.
Environment
The Hazardous Substances and New Organisms Act
(HSNO), passed by Parliament in 1996, falls under the
Ministry of the Environment. The purpose of the Act is to
protect people and the environment by preventing or
managing the adverse effects of hazardous substances and
new organisms, including those produced using gene
technology.
The Environmental Risk Management Authority (ERMA)
administers the HSNO. Its responsibilities include
assessing and approving the import, development,
field-testing, and release of genetically modified
organisms in New Zealand.
ERMA has the role of assessing the risks and benefits of
each case and deciding on all applications to introduce
genetically modified organisms into New Zealand. The
assessment procedures allow consultation with appropriate
Ministries, and includes a public notification process, so
that any interested person can make information available
for consideration before a decision is reached.
Aquaculture
GM aquaculture is regulated under the HSNO Act, which
protects the environment and people. The process may
involve other ministries as appropriate. For example, a
recent decision regarding a Chinook salmon involved ERMA
and comments from the Department of Conservation, the
Ministry of Agriculture and Forestry, and the New Zealand
Fish and Game Council.
Non-Science Issues
New Zealand has not accorded a high priority to
non-science issues in regulating the products of
biotechnology. The HSNO Act does not allow ERMA to
consider ethical issues (except in relation to Maori
concerns). The Authority will consider applications where
they are considered to be of special significance or
public interest (as with the insertion of copies of human
genes into sheep). Normally however, they are examined by
one of the standing committees for new organisms, or
genetically modified organisms.
The HSNO Act provides that the Authority will take into
account the relationship of Maori, their culture and
traditions with ancestral lands, water, sites and, other
taonga, and that it shall take into account the principles
of the Treaty of Waitangi, signed in 1840. The Authority
has taken the view that these provisions of the Act
require it to take into account the impact of an
application on Maori cultural traditions, and therefore,
for example, to have regard to the cultural abhorrence to
Maori of transgenic modification.
This has led, in turn, to issues regarding the adequacy of
information provided by applicants, consultations held
with Maori, and the representation of their cultural
tradition. It has also led the Authority to determine what
weight to attach to an affront to a traditional cultural
value in assessing the risks, costs and benefits of an
application.
Maori cultural traditions are reasonably well defined and
well understood by both the Waitangi Tribunal and the
Environment Court. Reconciling these with the science of
biochemistry and molecular biology however, will require
care and time, and the Authority believes that this will
be facilitated by looking at the individual circumstances
of each situation and by talking to the people directly
involved.
Independent Biotechnology Advisory
Council
The Independent Biotechnology Advisory Council (IBAC) was
established by the Minister of Research, Science and
Technology in May 1999, to meet the need for advice and
informed public debate about biotechnology. IBAC helps New
Zealand explore and consider issues arising from advances
in biotechnology. Its main role is to stimulate dialogue
and enhance public understanding about biotechnology. IBAC
also provides independent advice to Government on the
environmental, economic, ethical, social and health
aspects of biotechnology. IBAC will be an independent,
balanced voice on biotechnology issues. It will inform and
enrich debate. It will not always aim for agreement on
issues but enable a range of perspectives on biotechnology
to be recognized and respected.
-
3.10 Japan
Food
Since 1991, the Ministry of Health and Welfare has been
assessing the safety of foods and food additives produced
by recombinant DNA techniques individually, based upon the
"Guideline for Safety Assessment of Foods and Food
Additives Produced by Recombinant DNA Techniques."
Using these guidelines, a risk assessment on the
environmental and human health effects is undertaken,
prior to commercialization. The assessment is
science-based, with reference to the criterion of
substantial equivalence.
This assessment has been conducted on a voluntary basis.
In May 2000, the Ministry decided to make the safety
assessment of GM foods and food additives mandatory.
Relevant announcements were published to amend the
existing regulations. This will take effect in April 2001.
The announcement determines procedures for the safety
assessment of foods and food additives defined in the
amended Specifications and Standards:
-
The Minister for Health and Welfare examines the
necessary documents for applications on the safety
assessment of foods and food additives.
-
The examinations are performed based on consultations
with the Food Safety Investigation Council.
-
The Minister is obliged to publish the announcement in
the official gazette, indicating the fact that their
safety assessment has been examined, unless there are
certain risks considered injurious to human health.
After April 1, 2001, any foods and food additives produced
by recombinant DNA techniques that have not had a safety
assessment may not be imported or sold in Japan.
The Government of Japan is scheduled to establish
labelling standards for GM foods that have been approved
and to make such labelling mandatory commencing in April
2001.
Medical Products
Genetically engineered medical products are regulated by
the “Guidelines for the Manufacture of
Pharmaceuticals, etc., Utilizing rDNA
Technology" (Guidelines for Pharmaceuticals),
which are under the Ministry of Health and Welfare. Crops
The Organization for Economic Cooperation and Development
(OECD) and other bodies are preparing an international
framework for the application of recombinant DNA organisms
in various agricultural and industrial uses. In this
connection, the Japanese government has already
established certain guidelines for the safety assessments
of the application of rDNA crop plants in agriculture,
forestry, fisheries and the food industry—“The
Guidelines for Application of rDNA Organisms in
Agriculture, Forestry, Fisheries, the Food Industry and
Other Related Industries". These guidelines cover the
following cases:
-
the domestic cultivation of GM crop plants, or the
import of such crop plants that may propagate in a
natural environment;
-
GM crop plants to be used in the manufacture of feed
products; and
-
GM crop plants to be used in the manufacture of food
products.
These guidelines are under the Ministry of Agriculture,
Forestry and Fisheries and are intended to promote the
safe progress of agro-industries by:
-
defining general principles for the appropriate
application of GM organisms; and
-
ensuring safety in the use of GM organisms.
Environment
Environment is regulated under the “Guidelines for
Application of Recombinant DNA Organisms in Agriculture,
Forestry, Fisheries, The Food Industry and Other Related
Industries,” (Ministry of Agriculture, Forestry and
Fisheries - MAFF).
Applications for field trials of GMOs must be approved by
MAFF through biosafety assessments conducted by the
authorized committee under MAFF. Prior to the application
of a genetically engineered organism in the environment,
the safety of the proposed application has to be confirmed
through evaluation in a "simulated model
environment"
Aquaculture
Biotechnology in fisheries is regulated by the
“Guidelines for Application of Recombinant DNA
Organisms in Agriculture, Forestry, Fisheries, The Food
Industry and Other Related Industries,” (August
1995) which falls under the Ministry of Agriculture,
Forestry and Fisheries.
Non-Science Issues
It is apparent that the main non-science issue dealt with
by the government is the labelling of GM products. As
well, the government has made the regulatory system
transparent by emphasizing communication to the public and
by providing access to materials submitted to advisory
bodies in connection with GM foods.
-
3.11 Argentina
Food And Medical Products
In December 1993, the Secretary of Health created the
National Committee on Biotechnology and Health (CONBySA).
CONBySA is responsible for advising on the development and
application of biotechnology in the field of health.
It also analyses and studies effective regulatory norms
that govern the development, processing and approval of
biotechnology products for the purposes of human health
and human consumption.
Crops
The Secretary of Agriculture, Fisheries and Food is the
authority responsible for licensing experimentation on,
and/or releases of, GMOs in the environment. The Secretary
acts on the advice of the National Advisory Commission for
Agricultural Biotechnology (CONABIA).
CONABIA was established in 1991 to co-ordinate
biotechnology regulations concerning the biosafety of the
introduction and environmental release of transgenic
material. It is composed of representatives of both public
and private sectors engaged in agricultural biotechnology.
Originally, applications for GMO trials were conducted on
a case-by-base basis. However, Argentina felt that
specific regulations were needed regarding the research
and/or release of GMOs into the environment. These rules
were established in 1992 and 1993. They are part of the
general regulatory system governing agriculture and animal
health including plant protection, seeds and phytogenetic
creations, and animal health.
As part of the variety registration process, an analysis
must be done of the GMO to determine its economic impact
on growers.
CONABIA also advises the Secretary of Agriculture,
Fisheries and Food on the design and management of
regulations concerning the introduction and environmental
release of transgenic material.
Environment
CONABIA provides the biosafety element for each of the
approvals, environmental assessment, feeds, human health,
and variety registration. The biosafety of released
organisms is determined on the basis of their
characteristics, the agro-ecological features of the site
where they are intended to be released, and compliance
with appropriate testing conditions.
Aquaculture
The Secretary of Agriculture, Fisheries and Food is the
authority responsible for licensing experimentation on
and/or releases into the environment of GMOs. The
Secretary acts on the advice of CONABIA.
Non-Science Issues
Argentina does not have mandatory labelling requirements
and does not support mandatory labelling of GM foods.
During a meeting of the Codex Alimentarius Committee on
Food Labelling in April 1999, the Delegation of Argentina
stressed the importance of the role of science and risk
analysis as a basis for decisions in Codex, and pointed
out that there was no scientific basis for requesting
information on the mode of production in the specific case
of biotechnology, especially as this would not offer any
additional guarantee concerning the safety of the food.
There are no ethics bodies that provide input into the
regulatory process. However, CONABIA and CONBySA have
representatives from the public and other stakeholders
among their members. They include the Association of
Argentine Seeders, the Argentinean Forum of Biotechnology,
the Argentine Chamber Veterinary Products, and the
Argentine Society of Ecology.
The Argentinean Forum of Biotechnology (Foro Argentino de
Biotecnología) is a non-government private
non-profit organization that was created in 1986. Its
mission is to disseminate biotechnology in Argentina,
promote policies and public awareness, develop joint
strategies with the industry, government and research
community, and establish linkages and networking between
Argentinean and international firms.
-
Emerging Best Practices
No one national system of dealing with non-science issues in the
regulation of biotechnology can be said to be the
“best” system. However, there are various practices
that appear to be the “best.” They have evolved over
the years and been demonstrated to be effective within their
socio-economic environment. Taken together, these practices
suggest approaches for government to deal with non-science
issues.
The tables that follow set out the best practices for framework
policies, ethics bodies, consumer roles, and stakeholder input
on regulatory policy. These practices are not necessarily the
ones Canada should adopt. That decision should take into account
Canada’s present regulatory system and existing government
structures, mandates, and processes related to biotechnology.
Best Practices - Framework Policies and
Legislation
|
Best Practices
|
Rationale
|
-
non-science considerations are incorporated in
framework legislation that governs regulatory
procedures
-
regulatory assessment is sciencebased and reflects
legislated requirements
|
-
societal values are debated and become enshrined in
framework legislation
-
uncertainty as to the regulatory considerations and
added financial risk are avoided at the regulatory
stage
|
Best Practices - Ethics Advisory Body
|
Best Practices
|
Rationale
|
|
Structure And Composition
|
-
independent body established by government
|
-
institutionalizes the structure and process for
obtaining advice on ethical issues
|
-
Chairperson and minority of members appointed by
government
|
-
public should view body as providing independent
advice
|
-
Body has a mix of expert professionals and lay
persons
|
-
assists in reaching out to the public; lends
credibility
|
|
Mandate
|
-
Mandate should include:
-
providing advice to government on ethical
issues and framework policies
-
engaging and educating the public on
ethical issues
-
keeping informed with respect to research
and scientific developments, to anticipate
and act upon ethical issues that are likely
to arise
-
advising on medical, food, animal and
environmental matters
|
-
a strong and visible public role is important to
develop consensus on responses to ethical issues,
educate the public on such issues, and create a
positive climate for consumer acceptance
-
to the extent possible, it is preferable to
anticipate and act upon ethical issues, rather
than respond to them as they arise
-
there are relationships between the ethical
issues that arise in medical, animal and plant
applications of biotechnology
|
Best Practices - Consumer Roles
|
Best Practices
|
Rationale
|
-
establish a Consumer Committee on the human
applications of biotechnology
|
-
provides effective mechanisms for consumers to
channel their views and advice
|
-
place a consumer representative on scientific
advisory committees
|
-
create an Office of Consumer Affairs to provide the
Secretariat for the Consumer Committee and be the
focal point in government to address consumer
interests
|
-
Annex 1 - References
United States
European Commission
-
Opinions of The Group of Advisors to The European
Commission
Ethical Implications of Biotechnology
1991-1997
European Commission (1998)
-
The European Group on Ethics in Science And New
Technologies
European Commission
(September 1998)
-
Adoption of an Opinion on Human Embryo Research
The European Group on Ethics in Science And New
Technologies
(November 1998)
-
European Industrial Policy For The 1990s
Promoting The Competitive Environment For Industrial
Activities Based on
Biotechnology Within The Community
Bulletin of the European Commission
Supplement 3/91
-
The Europeans And Modern Biotechnology
Eurobarometer 46.1
European Commission
-
The Regulation of Modern Biotechnology: An Historical And
European
Perspective
Mark F. Cantley
Paris
-
The Legal Protection of Biotechnological Inventions
Directive 98/44/EC
European Parliament
July 1998
-
Biotechnology – Patenting Inventions
EUR-OP
European Commission
(http://publications.eu.int/general/en/index_en.htm)
-
EU Sets Genetic Food Label Rules
Associated Press
(June 18, 1997)
-
Labelling of Genetically Modified Organisms
European Commission
(December 1998)
-
Scientific Aspects And The Presentation of Information
Necessary to Support
Applications For the Placing on The Market of Novel Foods
And Novel Food Ingredients
97/618/EC – Commission Recommendation (July 1997)
Denmark
Britain
-
New Measures on Biotechnology
Cabinet Office Press Release
May 21, 1999
-
The Advisory and Regulatory Framework for Biotechnology:
Report From The Government’s Review
Cabinet Office
Office of Science and Technology
May 1999
-
Review of the British Biotechnology Advisory Committee
System
Office of Science and Technology
Department of Trade and Industry (DTI)
(December 1998)
-
Department of Health
(http://dtiinfo1.dti.gov.uk/bioguide/doh.htm)
-
Human Genetics Commission (HGC)
(http://www.hgc.gov.uk/)
-
Agriculture and Environment Biotechnology Commission
(AEBC)
(http://www.aebc.gov.uk/)
-
Medicines Control Agency (MCA)
(www.open.gov.uk/mca/mcahome.htm)
-
Ministry of Agriculture, Fisheries and Food
(http://dtiinfo1.dti.gov.uk/bioguide/maff.htm)
-
Rooker Puts New Powers on The Menu
Ministry of Agriculture, Fisheries and Food
Press Release (March 18, 1999)
-
Ministry of Agriculture, Fisheries and Food
Advisory Committee on Novel Foods and Processes (ACNFP)
(
http://www.foodstandards.gov.uk/science/ouradvisors/novelfood/)
-
Advisory Committee on Novel Foods and Processes
Annual Report
(1997)
-
Scientists Back Critic of Gene Modified Potatoes
The Times of London
February 12, 1999
-
Genetically Modified Food – The Political Debate
The Times of London
February 13, 1999
-
Genetic Resistance
The Times of London
February 13, 1999
France
-
L’Agence Française de
sécurité sanitaire des produits de
santé
(http://agmed.sante.gouv.fr/)
-
Regulatory Developments in Biotechnology in France (OECD)
(
http://www.oecd.org/document/33/0,2340,en_2649_34393_2370849_1_1_1_37401,00.html)
-
Comité consultatif national
d’éthique pour les sciences de la vie et de la
santé
(http://www.ccne-ethique.fr/english/start.htm)
-
Avis No 60 – Examen des lois de
bioéthique
Comité consultatif national d’éthique
pour les sciences de la vie et de la santé
(25 juin 1998)
(http://www.ccne-ethique.fr/english/avis/a_060p12.htm)
-
Ministère de
l’agriculture et de la pêche
Commission du génie
biomoléculaire
(http://www.agriculture.gouv.fr/)
-
Ministère de l’agriculture at de
la pêche, “A l’étiquetage des
produits dérivés du mais et du soja
génétiquement modifiés
(http://www.agriculture.gouv.fr/spip/)
-
Ministère de l’envnvironment,
“Les organismes génétiquement
modifiés (ogm): risques et
perspectives”
http://www.environnement.gouv.fr/
-
A Report on the “Citizens Conference” on
Genetically Modified Food,
France,
June 21-22, 1998
(http://www.loka.org/pages/Frenchgenefood.htm)
-
United Nations Industrial Development Organization (UNIDO),
BINAS News, Vol. 4, issue 1, 1998
(http://binas.unido.org/binas/binasnews/i1-98.pdf)
Norway
-
Act Relating to The Application of Biotechnology in
Medicine
Ministry of Health and Social Affairs
(August, 1994)
-
Gene Technology Act
(
http://binas.unido.org/binas/show.php?id=17&type=html&table=regulation_sources&dir=regulations
)
-
Bioteknologinemnda
(Biotechnology Advisory Board)
(www.bion.no)
-
European Economic Area (EEA) (http://europa.eu.int/comm/external_relations/eea/gac.htm)
-
OECD, Regulatory Developments in Biotechnology in Norway
(
http://www.oecd.org/document/56/0,2340,en_2649_34393_1890552_1_1_1_1,00.html)
-
UN, Economic Aspects of Sustainable Development in Norway
(
http://www.un.org/esa/agenda21/natlinfo/countr/norway/eco.htm)
-
National Committee for Research Ethics, “Fast Salmon
and Technoburgers”
http://www.etikkom.no/NENT/fast.htm
-
The Ram’s Horn, No. 180, May 2000, “Codex:
Adapting to Survive”
(http://www.ramshorn.bc.ca/archive/180.html)
Australia
New Zealand
Japan
-
Guidelines for Application of Recombinant DNA Organisms in
Agriculture, Forestry, Fisheries, The Food Industry, and
Other Related Industries
Ministry of Agriculture, Forestry and Fisheries
August 1995
-
Foods and Food Additives Produced by Recombinant DNA
Techniques
Ministry of Health and Welfare
(http://www.mhlw.go.jp/english/topics/food/3-5.html)
-
White Paper, Annual Report on Health and Welfare
Ministry of Health and Welfare
(http://www.mhlw.go.jp/english/wp/wp-hw/index.html)
-
Amendments to the Specifications and Standards of Foods and
Food Additives for Mandatory Requirement of Foods and Food
Additives Produced by Recombinant DNA Techniques
Environmental Health Bureau, Ministry of Health and
Welfare
May 1, 2000
(http://www.mhlw.go.jp/english/topics/food/3-5.html)
Argentina
-
Biosafety Information Network and Advisory Service (BINAS),
United Nations Industrial Development Organisation
(UNIDO).
(http://binas.unido.org/binas/)
-
Jason Flint, et al, “Biosafety Information Management
Systems: A Comparative Analysis of the Regulatory Systems in
Canada, Argentina, and Chile,” Electronic Journal of
Biotechnology, Vol. 3, no. 1, April 15, 2000,
(
http://www.scielo.cl/scielo.php?script=sci_abstract&pid=S0717-34582000000100002&lng=es&nrm=iso&tlng=en
)
-
Secretary of Agriculture, Fisheries and Food, CONABIA
(
http://siiap.sagyp.mecon.ar/http-hsi/english/conabia/frameing.htm)
-
Secretary of Agriculture, Fisheries and Food, CONABIA,
Agricultural and Livestock Biosafety
(
http://siiap.sagyp.mecon.ar/http-hsi/english/conabia/arin.htm)
OECD
-
Compendium of National Food Safety Systems
SG/ADHOC/FS(2000)5/ANN/FINAL
June 2000
-
Report of The Working Group on Harmonisation of Regulatory
Oversight in Biotechnology
C(2000)86/ADD2
May 2000
-
Overview of National Food Safety Systems and Activities
SG/ADHOC/FS(2000)5/FINAL
May 2000
-
OECD Consultation With Non-Governmental Organisations on
Biotechnology And Other Aspects of Food Safety (November
1999)
C(2000)86/ADD4
May 2000
-
Rapporteur’s Summary and Chairman’s Report
– OECD Edinburgh Conference on The Scientific And
Health Aspects of Genetically Modified Foods (28 February
– 1 March 2000)
Other
-
Non-Science Issues In The International Regulation of The
Products of Biotechnology For Human Health
Health Canada
Secor (April 1999)
-
Genetically Modified Crops: The Ethical and Social Issues
Nuffield Council on Bioethics
May 1999
-
G8 Summit Communiqué
Okinawa, 23 July 2000
-
Seventh Annual European Life Sciences Report 2000
Ernst & Young Life Science Group
Ernst & Young International
London
-
Ethical Dilemmas
New Scientist
17 October 1998
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