SUMMARY
- The EC has issued
a number of directives that relate to different uses with GMOs and GM
products.
- In relation to
the use of GMOs, there are three relevant directives:
- contained
use of GM micro-organisms;
- deliberate
release of GMOs into the environment and placing on the market; and
- protection of workers from the risks of
exposure to biological agents.
- In relation to GM
products, there are also a number of relevant directives:
- additives
in feeding stuffs;
- medicinal
products; and
- novel
food.
|
Contained work with
GMOs
|
Responsible agency
|
-
The
Council of the European Communities.
|
Legislation
|
-
Council
Directive 90/219/EEC for contained use of genetically modified
micro-organisms.
|
Intentional releases
of GMOs in the environment
|
Responsible agency
|
-
The
Council of the European Communities.
|
Legislation
|
-
Council
Directive 90/220/EEC regulates the deliberate release of GM microorganisms
into the environment.
|
Coverage of the
legislation
|
-
The
deliberate release of GMOs into the environment.
|
Assessment process for
intentional releases of a GMO into the environment
(field trials and
general releases)
|
-
Member states must ensure that all appropriate
measures are taken to avoid adverse effects on human health and the
environment which might arise form the deliberate release or placing on the
market of GMOs.
-
Member
states shall designate a competent authority responsible for carrying out the
requirements of the Directive.
-
A
person must submit notification about the proposed release including a
technical dossier with all of the information annexed to the Directive and an
evaluation of the impacts.
-
The
competent authority must examine the application for compliance with the
directive and evaluate the risks posed by the release - this must be a science
based consideration.
-
The
competent authority may consult on any aspect of the proposed deliberate
release.
-
A
notification may only proceed with the release having received written
consent and in conformity with any conditions required in the consent.
-
The
competent authority shall send to the commission the results of the decision
and the Commission shall forward summaries to other Member States.
|
Consideration of
ethical issues
|
-
The
Directive does not make any reference to the need for ethical matters to be
considered.
|
Public consultation on
applications
|
-
The
Directive provides that the competent authority may consult on any
application in relation to a deliberate release. There is not, however, any express or
mandatory requirement for public consultation.
|
Conditions that may be
applied
|
-
The
Directive provides that competent authorities may grant approvals subject to
conditions.
|
Monitoring,
surveillance and enforcement powers
|
-
The
Directive provides that Member States shall ensure that the competent
authority organises inspections and other control measures as appropriate to
ensure compliance with the Directive.
|
Penalties
|
-
The
Directive does not include any penalties as it is up to individual Members
States as to how they implement the Directive (through legislation) and the
penalties imposed.
|
Liability
for contamination
|
-
The EC directive does not deal explicitly with liability,
including liability for contamination.
-
To ascertain liability, the general law in each
jurisdiction would need to be applied.
However, the EC has published a White Paper on Environmental Liability
which is relevant.
|
Policy and Governance
issues
|
Expert Committees
|
|
Research
|
Not applicable
|
Other
|
The precautionary
principle
|
-
The
Directive does not explicitly reference the precautionary principle
|
Cost recovery
|
|
Moratorium
|
|
Other
|
-
Amendments
to the Directive have recently been proposed.
The EC is yet to vote on the amendments.
|
SUMMARY
- The UK has
implemented EC Directive 90/110/EC through Part VI of the Environment
Protection Act 1990 and the issuance of the following regulations:
- Genetically
Modified Organisms (Contained Use) Regulations 1992, as amended in 1996 and 1998;
- Genetically
Modified Organisms (Deliberate Release) Regulations 1992 (SI 1992/3280); and
- Genetically
Modified Organisms (Deliberate Release) Regulations 1995 (SI 1995/304).
- There appears to
be no statutory requirements for an interface between the regulation of
GMOs and GM products.
|
Contained work with
GMOs
|
Responsible Agency
|
-
The
Health and Safety Executive (HSE). The
HSE shapes and implements policy for the Health and Safety Commission, whose
members are appointed by the Secretary of State for the Environment.
|
Legislation
|
-
Genetically
Modified Organisms (Contained Use) Regulations 1992, as amended in 1996 and
1998.
- Contained
use is defined as any operation in which organisms are genetically modified
or in which GMOs are cultured, stored, used, transported, destroyed or
disposed of and where physical barriers (possibly combined with chemical
and/or biological barriers) are used to limit their contact with the general
population and the environment. General
release includes field trials for research purposes, and commercial releases
of GMOs.
- The
Contained Use Regulations require persons who intend to carry out any act in
which organisms are genetically modified, or intend to culture, store or use
GMOs to:
(a) carry out (and keep records of) risk assessments
beforehand, where specified; and
(b) notify the Health and Safety Executive of
their proposals and;
(c) for certain activities, to obtain written
consent.
|
Intentional releases
of GMOs in the environment
|
Responsible agency
|
-
The
Department of the Environment, Transport and the Regions (DETR) for consent
for marketing or release of a GMO.
|
Legislation
|
-
Part
VI of Environment Protection Act 1990: Genetically Modified Organisms
(Deliberate Release) Regulations 1992 (SI 1992/3280) and the Genetically
Modified Organisms (Deliberate Release) Regulations 1995 (SI 1995/304).
-
The
regulations implement EC Directive 90/110/EC.
|
Coverage of
legislation
|
-
The
culturing storage, use, transport, destruction, disposal, release (field
trials for research purposes and commercial releases) into the environment or
marketing of GMOs. GMO is defined as an organism that has been altered by
genetic modification.
|
Assessment process for
intentional releases of a GMO into the environment
(field trials and
general releases)
|
-
The Deliberate Release Regulations requires that everyone
who intends to release GMOs to the environment, or to sell products
consisting of or containing GMOs, must first obtain a consent from the
Department of the Environment.
-
Application
must be made to the Department of the Environment.
-
Application
must include a risk assessment prepared by the applicant.
-
The
Department audits the application to ensure that the risk to human health and
the environment has been minimised.
-
The
Department seeks the advice of expert committees. Various advisory committees have been set
up to examine the risk assessment and management procedures set out in
applications and advise whether the work/release should proceed or work
procedures amended. For example:
- higher
risk contained use applications are reviewed by the Advisory Committee on
Genetic Modification; and
- general
release applications are reviewed by the Advisory Committee on Releases to
the Environment (ACRE). ACRE carries
out an assessment of the application and advises on the risks posed to human
health and the environment, whether a consent should be granted and whether
any risk management of the release should be required as a condition of
consent.
Once the assessment of
the application is complete, the final decision rests with the Secretary of
State for the Environment and the Minister of Agriculture, Fisheries and
Food. Release may only take place with
the consent of both the Secretary of State for the Environment and the Minister
of Agriculture, Fisheries and Food.
|
Consideration of
ethical issues
|
-
Ethics
issues are not directly considered in relation to each application, however,
ethicists have been placed on advisory committees.
|
Public consultation on
applications
|
-
There
appear to be no statutory requirements for public consultation.
|
Conditions that may be
applied
|
-
Conditions
can be placed on general releases.
-
Requirements
for post-release monitoring and reporting can be imposed as a condition of
release.
|
Monitoring,
surveillance and enforcement powers
|
-
Auditing
of research and marketing releases is undertaken by specialist inspectors of
the HSE on behalf of DETR, to ensure conditions of consent are complied
with. Inspectors can take action where
breaches are detected (including fines).
|
Penalties
|
-
Information
is not available at this time
|
Liability
for contamination
|
-
Liability
for environmental damage is generally imposed by general statute, and examples include land
contamination, waste disposal, and water pollution. However, there is no
specific statute dealing with liability for contamination by GMOs, and
plaintiffs must look to the common law or general statutes for remedies.
|
Policy
and Governance issues
|
Expert Committees
|
-
Following
a review on biotechnology regulation in 1999, the UK Government decided to establish
two new bio-technology specific bodies in order to create a more strategic
advisory structure. The Human Genetics
Commission is to advise on gene technology and its impact on humans, and the Agriculture and
Environment Biotechnology Commission is to advise on all other aspects of
biotechnology except food.
|
Research
|
DETR contracts out specific research
projects investigating the risks associated with GMOs.
|
Other
|
The precautionary
principle
|
-
There
is no direct reference to the precautionary principle in the Regulations.
|
Cost recovery
|
-
There
is a level of cost recovery - further information is being sought on the
precise level of cost recovery imposed.
|
Moratorium
|
-
The UK
Government initially entered into a voluntary agreement with industry that no
GM crops will be grown commercially in the UK for at least 2 years. In the mean-time, farm-scale field trials
will be conducted to assess the safety of GMOs. Until these tests demonstrate that the risk
is minimal, no GMOs will be allowed to be released in the UK. In November 1999, companies agreed to wait
until the end of a 3.3 million pound government-funded experiment to see if
GM crops damage wildlife more than conventional crops before growing crops
commercially. The trial ends in 2002,
delaying the commercial growing of GM crops in Britain for another 3 years.
|
SUMMARY
- Research with GMOs and release of GMOs into the environment in
Germany is regulated under one piece of legislation - the Genetic Engineering Act.
- There appears to be no statutory link (or one-stop shop) between
legislation to regulate GMOs and GM products (such as GM therapeutics
and agricultural and veterinary chemicals).
- Note: It
was not possible to obtain a copy of the Genetic Engineering Act in English and as such all of the
information contained in this report is based on summary information
including that published on Biotrack Online by the relevant German
authorities.
|
Contained work with GMOs and intentional releases of GMOs into the
environment
|
Responsible agency
|
-
Federal
Ministry of Health (the Robert Koch-Institut - RKI) - for the licensing of
and release of GMOs and the marketing of products containing them.
-
The
Federal States (for contained work).
|
Legislation
|
-
The
Genetic Engineering Act.
|
Coverage of the legislation
|
-
Recombinant
micro-organisms, viruses, cells, plants, animals and plasmid vectors.
-
This
Act regulates GMOs in closed systems (laboratory and production areas), field
experiments with GMOs and the placing on the market of products containing
GMOs. Reproductive medicine and the
use of somatic-genetic therapeutic procedures in humans are not covered by
the legislation.
|
Assessment process for intentional releases of a GMO into the
environment
(field trials and general releases)
|
-
Regulation is risk-based - the law divides
work with rDNA into four safety levels (class one being the lowest level of
risk), with activities considered to be of higher risk subject to more
stringent requirements. For example:
- commercial
work in class one need only be notified to the authorities (no permissions
needed);
- academic
research in all four classes need only be notified to the authorities (no
permissions needed); and
- commercial
work in classes 2, 3 or 4 requires permission.
-
Applications for release of a GMO (including
field trials) must be made to the RKI.
-
The RKI seeks advice from:
- the Federal
Environment Agency and Federal Biological Research Centre for Agriculture and
Forestry and, in the case of releases of animals, the Federal Research Centre
for Virus Diseases of Animals;
- the Advisory
Committee for Biological Safety; and
- the
competent authority of the State in which the GMO is proposed to be used.
-
The RKI makes decisions in agreement with: the Federal
Environmental Agency (Federal Ministry of Environment); the Federal
Biological Research Center
for Agriculture and Forestry (Federal
Ministry of Food, Agriculture
and Forestry) and the Federal Research Center for Virus Diseases of
Animals (in the case of GM vertebrates or GM micro-organisms that are applied
to vertebrates).
-
In relation to contained uses of GMOs, the States are
responsible for assessing applications under the legislation. The responsible authorities of the States
seek advice from the Central Advisory Committee for Biological Safety and
inform the RKI of their decisions.
|
Consideration of ethical issues
|
-
On the
basis of the information available, it does not appear that ethics are taken
into account as part of the decision making process on individual
applications.
|
Consultation on applications
|
-
On the
basis of the information available, it does not appear that there is any
statutory requirement for public consultation on individual applications.
|
Conditions that may be applied
|
-
A
series of regulations have been issued under the Genetic Engineering Act
specifying requirements, procedures and safety precautions to be observed.
For example:
- Regulations on Containment Levels and
Safety Measures for Genetic Operations in Genetic Engineering Installations;
- Regulations on the Advisory Committee for
Biological Safety;
- Regulations on the Keeping of Records for
Genetic Operations; and
- Regulations on Hearing Procedures
and Regulations on Application and Notification Documents.
|
Monitoring, surveillance and enforcement powers
|
-
There
are significant monitoring and enforcement powers available under the
legislation.
|
Penalties
|
-
A
maximum fine of $1,000,000 or a prison term of 3 years.
|
Liability for contamination
|
-
The
Act imposes a strict liability regime for any damage caused by the deliberate
release of GMOs.
-
On the
basis of secondary sources, it is understood that the legislation provides
that the producer of a GMO is strictly liable for any damage caused by the
release of the GMO. Liability is
limited to DM 160 million (AUD 127 million).
|
Policy and Governance issues
|
Expert Committees
|
The Central
Advisory Committee for Biological Safety (Zentrale Kommission fr die
Biologische Sicherheit - ZKBS) was established in 1978, in conjunction with
the development of guidelines on the protection against hazards from in-vitro
recombinant nucleic acids. After the
Genetic Engineering Act came into force, the Central Advisory Committee for
Biological Safety was constituted as an institution. The Committee consists
of thirty scientific or technical experts and experts from other relevant
fields (15 members and 15 deputy members) who work on an honorary basis. The
members are either experts in the fields of microbiology, cell biology,
virology, genetics, hygiene, ecology and technical safety which are, in most
cases, familiar with the methods of genetic engineering or experts from trade
unions, occupational safety, economy, research-promoting organizations and
environmental protection.
-
The
Committee undertakes safety evaluation of GMOs, and provides advice to the
States and other institutions dealing with GMOs. This applies to experimental
research in the laboratory, operations for production purposes in industrial
fermentation facilities, and also the release and the placing on the market
of GMOs.
-
Work
of the Central Advisory Committee for Biological Safety is supported by its
Secretariat at the Centre for Gene Technology at the RKI.
|
Research
|
No information available at this time.
|
Other
|
The precautionary principle
|
-
No
information available at this time.
|
Cost recovery
|
-
No
information available at this time.
|
Moratorium
|
-
Chancellor
Schroeder recently proposed a 3-year program to explore the possible
environmental and health impacts of gene technology and to increase consumer
trust in gene products Industry would be required to give an
undertaking only to use genetically modified seed and plants and to cooperate
with the scientific and government sector.
|
SUMMARY
- One piece of legislation covers research with GMOs and release
of GMOs into the environment in New Zealand - the Hazardous Substances and New Organisms Act 1996 (HSNO Act).
- There appears to be no statutory link (or one-stop shop) between
legislation to regulate GMOs and GM products (such as GM therapeutics
and agricultural and veterinary chemicals).
|
Contained work with GMOs and intentional releases of GMOs
in the environment
|
Responsible agency
|
-
Environmental
Risk Management Authority (ERMA)
|
Legislation
|
-
Hazardous Substances and New Organisms Act (HSNO Act)
|
Coverage of the legislation
|
-
The
legislation covers the importation, development, field testing and release
from containment of new organisms.
- A new
organism includes any organism in which any of the genes or other genetic
material:
(a)
Have
been modified by in vitro techniques;
or
(b)
are
inherited, or otherwise derived, through any number of replications, from any
genes or other genetic material which has been modified by in vitro techniques. The term in vitro is not defined.
|
Assessment process for intentional releases of a GMO into the
environment
(field trials and general releases)
|
-
Any
person importing or releasing a ‘new organism’ into the environment must
apply to the ERMA for approval.
Approval may be given if the new organism is not likely to cause:
- any
significant displacement of any native species within its natural habitat;
- any
significant deterioration of natural habitats;
- any
significant adverse effects on New Zealand’s inherent genetic diversity; and
- disease,
become parasitic or become a vector for human, animal or plant disease.
-
In
addition, the positive effects of the GMO
must outweigh the adverse effects of the GMO.
For release of
GMOs into the environment
-
The
HSNO Act describes a specific procedure which must be followed in relation to
each application. When ERMA receives an application it must:
- inform the Minister for the Environment
and any government department or crown entity that is likely to express an
interest in the application;
- in relation to applications involving new
organisms, inform the Department of Conservation and any regional council
that is likely to express an interest;
- if the application is to field test or
release a GMO (ie if the GMO is not to be used in containment), publicly
notify the application (in relation to an application for contained work,
ERMA may publicly notify the application if it considers that there is likely
to be significant public interest).
The public notice invites people to make submissions on the
application. All submissions must be received by the date specified in the
public notice, and this date must be no longer than 30 working days
after the public notification was advertised. ERMA may also call a hearing to consider
the application and any submissions made;
- Consider the application and any
submissions made in accordance with documented assessment methodology;
- Consider the following principles:
- safeguarding
the life supporting capacity of air, water and ecosystems; and
- maintaining
and enhancing the capacity of people and communities to provide for their own
economic, social and cultural well being, and for the reasonable foreseeable
needs of future generations;
- consider:
- the
sustainability of all flora and fauna;
-
the
intrinsic value of ecosystems;
-
public
health;
-
the
relationship of Maori and their culture and traditions with their ancestral
lands, water, sites, waahi tapu, valued flora and fauna and other taonga;
-
economic
and related values; and
-
New
Zealand's international obligation
For low risk contained work
-
The
Act allows ERMA to delegate assessment decisions in these cases. For
example, approval decisions may be delegated to approved biological safety
committees attached to research institutions. The definition of "low
risk" in this case is set out in regulations made under section 41.
|
Consideration of ethical issues
|
-
No
specific mention is made of ethical concerns, except in relation to Maori
concerns. However, it is possible that ethical concerns could be addressed
when weighing up the positive and adverse effects of an application,
especially as section 5 provides that persons exercising functions under the
Act should recognise and provide for the maintenance and enhancement of the
capacity of people and communities to provide for their own economic, social
and cultural wellbeing. However, harm (or adverse effects) would need to be
established.
|
Public consultation on applications
|
-
Refer
to assessment process. ERMA must
publicly consult on all applications for release into the environment for a
period of no longer than 30 days.
-
ERMA may
consult on applications for use of GMOs in contained settings if ERMA
considers that there is likely to be significant public interest on the
issue.
|
Protection of confidential commercial information
|
-
Provides
some protection for commercial in confidence information
|
Conditions that may be applied
|
-
There
is no provision for conditions to be imposed on general release approvals in
relation to GMOs.
-
Persons
with approvals to undertake contained GMO research and field trials can have
monitoring and inspection controls placed on them. It is also an offence for a manufacturer,
developer or importer of a GMO to knowingly fail to report any significant
adverse effect of a GMO.
|
Monitoring, surveillance and enforcement powers
|
-
Enforcement
officers can be appointed under the Act to promote and monitor compliance
with the provisions of the Act.
-
Enforcement
officers have powers of entry for inspection without consent to monitor the
conditions in a premises or to determine the nature of any organism in the
premises. Officers have extensive seizure powers and powers to take samples,
open containers, conduct examinations and inquiries, and to require the
production of documents. Enforcement officers can issue compliance orders to
require persons to cease, or prohibit persons from commencing, anything which
will, or is likely to, contravene the Act.
|
Offences/Penalties
|
-
One of
the key offences under the Act is manufacturing or developing a GMO in
contravention of the Act (maximum penalty of $500,000 or up to 3 months
imprisonment and $50,000 for every day on which the offence continues).
-
Similar
penalties for offences such as failing to comply with any controls in
relation to an approval.
|
Liability for contamination
|
-
The HSNO Act does not address the issue of
liability for contamination by GMOs and therefore it would be necessary for
plaintiffs to seek relief under common law.
-
Tort
law in New Zealand operates in a similar fashion to Australian law. To establish the tort of negligence a
plaintiff would need to show the existence of a duty of care, a breach of
that duty, causation of damages, proximity, and damage.
|
Policy and Governance issues
|
Expert Committees
|
-
The
Act does not establish any overarching expert scientific, community or
ethics committees. The legislation
does however acknowledge the roles of Institutional Biosafety
Committees. The IBCs can be approved
by ERMA and delegated authority to approve low risk containment work.
-
ERMA
has appointed a non-statutory advisory committee, Nga Kaihautu Tikanga Taiao,
to provide ERMA, on request, with information on Maori issues in relation to
individual applications.
|
Research undertaken by Regulator
|
It is not a statutory function of ERMA
to conduct, or commission, research.
|
Other
|
The precautionary principle
|
-
Section
7 of the Act states that all persons exercising functions, powers and duties
under this Act shall take into account the need for caution in managing
adverse effects where there is scientific and technical uncertainty about
those effects.
|
Cost recovery
|
-
ERMA
applies cost recovery and levies charges for services such as searching the
register, submitting applications, auditing and conducting public hearings.
|
Moratorium
|
-
On 17
April 2000, the Government announced a four-person Royal Commission headed by
former Chief Justice, Sir Thomas Eichelbaum, to inquire into genetic
modification.
-
The
Royal Commission's chief objective is to inquire into and report on the
strategic options available to enable New Zealand to address genetic
modification now and in the future. It may also recommend any changes in the
current legislative, regulatory, policy or institutional arrangements for addressing genetic modification
technologies and products in New Zealand.
-
The
Commission will have 12 months to report.
-
The
Government also announced that a voluntary moratorium on all applications for
the release of genetically modified organisms is to be negotiated between the
government and relevant industry and research groups (with industry groups
already expressing agreement with this approach). The moratorium will also
apply to field testing of GMOs, but with some exemptions (to be determined on
a case by case basis by the Minister for the Environment). The moratorium will be in force for the
length of the Commission's inquiry.
|
SUMMARY
- Controls on gene technology are essentially voluntary and
different aspects of gene technology are overseen by different
portfolios:
- Ministry
of Agriculture Forestry and Fisheries - oversee GMOs for use in agriculture;
- Science
and Research Agency - oversees experimentation in all research facilities other
than University research facilities;
- Monbusho
(Ministry of Education, Sports and Culture) - oversees experimentation in University research facilities; and
- In relation to GM products, the Ministry for Health and Welfare
approves GM products such as pharmaceuticals, medical treatments and
foods.
|
For contained work with GMOs
|
Responsible agency
|
-
Science
and Research Agency - for
experimentation in all research facilities other than University research
facilities.
-
Monbusho
(Ministry of Education, Sports and Culture)
- for experimentation in University research facilities.
|
Guidelines (no legislation)
|
Voluntary guidelines:
-
“Guidelines for rDNA
Experimentation” (for experimentation in facilities other than university
facilities) and;
- “Guidelines for rDNA Experimentation in University Research Facilities”.
|
For intentional releases of GMOs in the
environment
|
Responsible agency
|
-
Ministry
of Agriculture, Forestry and Fisheries (MAFF).
|
Guidelines (no legislation)
|
-
“Guidelines
for application of recombinant DNA organisms in Agriculture, Forestry,
Fisheries, the Food Industry and other related industries”.
-
The
system is based on administrative guidance with no underpinning legislation.
|
Coverage of the guidelines
|
-
The
release, production and use in agro-industries of rDNA organisms in both open
systems (without specific measures of containment) and simulated model
environments (e.g. experimental applications of rDNA in a restricted area).
|
Assessment process for intentional releases of a GMO into the environment
(field trials and general releases)
|
-
Any
person who wishes to utilize rDNA crop plants in agriculture must conduct
safety assessments in accordance with the guidelines.
-
Before
organisms can be applied to open systems or a simulated model environment,
the developer may request the approval of the MAFF to confirm that the safety
assessments satisfy the requirements of the Guidelines. Safety assessments undertaken by proponents
are examined by scientific advisory committees underpinning MAFF.
-
The guidelines
set out how safety is to be confirmed.
For example the guidelines set out:
- the way of conducting simulations
(including requirements for facilities, experimental equipment, cultivation,
storage, transport etc);
- the information required for a safety
evaluation of an organism (conducted by the proponent); and
- the institution of management systems
including appointment of a safety officer, an operations administrator, a
safety operations manager and a safe operations committee.
-
When a
safety assessment has been conducted in accordance with the guidelines, a
person may request the Minister of Agriculture, Forestry and Fisheries to
approve the safety criteria regarding safety assessment and procedures
utilised to ensure compliance with the guidelines.
|
Consideration of ethical issues
|
-
No
reference to ethics in the guidelines.
|
Public consultation on applications
|
|
Protection of confidential commercial information
|
-
Information
not available.
|
Conditions that may be applied
|
-
The
guidelines set out the requirements for various releases (eg education,
handling, reporting etc).
|
Monitoring, surveillance and enforcement powers
|
-
The
system is a voluntary one and as such there are no enforcement provisions.
|
Penalties
|
-
No
penalties as the system is a voluntary one.
|
Liability for contamination
|
-
Plaintiffs must seek redress for contamination by GMOs
under general law.
|
Policy and Governance issues
|
Expert Committees
|
-
Information
not available at this time.
|
Research undertaken by the Regulator
|
-
There is no statutory provision for
research to be undertaken on risks posed by GMOs.
-
However, significant research budgets
across various portfolios. For example
in 1998 in the Ministry of International Trade and Industry alone, over
AUD$100m was dedicated to biotechnology R&D, AUD$500,000 to bioindustry
safety assurance measures, AUD$2.2m to research into conservation and
biodiversity.
|
Other
|
The precautionary principle
|
-
No
reference to the precautionary principle in the Guidelines.
|
Cost recovery
|
-
Information
not available - but as the system is based on voluntary compliance with
guidelines it is unlikely that there is a cost recovery regime.
|
Moratorium
|
|
SUMMARY
- One piece of
legislation regulates the contained use of GMOs, trial releases of GMOs
and general releases in South Africa.
- The relationship
with GM product regulators is not clear.
|
Contained
work with GMOs and intentional releases of GMOs in the environment
|
Responsible agency
|
-
The
Minister’s delegate (the Registrar) on the advice of the Executive Council
for GMOs
|
Legislation
|
-
Genetically Modified Organisms Act 1997
|
Coverage of the
legislation
|
-
The
Act covers GMOs, the development, production, release, use and application of
GMOs (including viruses and bacteriophages) and the use of gene therapy (but
not human gene therapy).
-
A GMO
is defined as an organism, the genes or genetic material of which have been
modified in a way that does not occur naturally through mating or natural recombination
or both. ‘Organism’ means a biological entity, cellular or non-cellular,
capable of metabolism, replication, reproduction or of transferring genetic
material and includes a microorganism.
|
Assessment process for
intentional releases of a GMO into the environment
(field trials and
general releases)
|
-
Distinctions
are drawn between ‘contained use’, ‘trial use’ and ‘general release’ of GMOs.
-
A
permit is required to use facilities for the development, production, use or
application of GMOs, or to release such organisms into the environment.
-
Permit
applications must be submitted to the Registrar.
-
The
registrar seeks advice from the Executive Council on GMOs.
-
The
Council, through the Registrar, may request the applicant to submit a risk
assessment and, where required, an assessment of the impact on the
environment of the activity for which a permit is being sought.
-
The
Council, after consideration of the submitted assessments, authorises the
Registrar to issue a permit.
-
In
coming to its decision, the Council must consult the Advisory committee
(discussed below).
|
Consideration of
ethical issues
|
-
Ethical
issues are not addressed in the legislation.
|
Public consultation on
applications
|
-
There
is no public consultation requirement in the legislation
|
Protection of
confidential commercial information
|
-
No
person shall disclose information acquired by them in performance of duties
under the Act, except in certain circumstances.
-
The
Council will decide, after consultation with an applicant, which information
will be kept confidential, but this cannot include descriptions of GMOs, the
purpose of contained use or release,
the location of use (although it is not clear what level of detail is
necessary), methods and plans for monitoring of GMOs and for emergency measures,
and the risk assessment.
-
However,
the information can be withheld if it is in order to protect the intellectual
property of the applicant.
|
Conditions that may be
applied
|
-
The
Executive Council may approve permit applications subject to such terms and
conditions as the Council may deem necessary.
|
Monitoring,
surveillance and enforcement powers
|
-
Under
the Act, the Executive Council can require the Registrar to arrange for the
inspection of facilities where activities with or release of GMOs are being undertaken,
or the inspection of all activities which the Registrar deems necessary to
ensure that the terms and conditions attached to a permit are being complied
with.
-
Inspectors
may conduct an investigation to determine whether the provision of the Act
are being complied with. However, they can only do so on the authority of a
warrant.
-
During
working hours, inspectors may also, without a warrant, enter any place or
facility registered in terms of the Act in order to open containers, examine
GMO material and inspect activities and records in connection with GMOs
(monitoring power).
-
The
Registrar may also authorise inspectors to destroy GMOs where the registrar
has ascertained or suspects on reasonable grounds that GMOs are being
imported, used or produced contrary to the provisions of the Act or the
conditions of a permit.
|
Penalties
|
-
It is
an offence under the Act to contravene or fail to comply with any condition,
restriction, prohibition, reservation or directive imposed or issued in terms
of the Act, or to obstruct and hinder an inspector, or to refuse or fail to
furnish information or give an explanation or reply to the best of your
ability.
-
Penalty
for first conviction is a fine (no maximum limit prescribed) or maximum
imprisonment period of 2 years.
-
Penalty
for subsequent offences is a fine or maximum imprisonment of 4 years.
|
Liability
for contamination
|
-
Section 17 of the Act provides that the
liability for damage caused by the use or release of a GMO shall be borne by
the user concerned. Clarification of
the impact of this provision is currently being sought.
|
Policy
and Governance issues
|
Expert Committees
|
-
Executive Council for Genetically Modified
Organisms: consists of no more than eight members
appointed by the Minister. It is
essentially a bureaucratic committee established under the legislation and
comprising one member from the
Departments of Agriculture, Arts, Culture, Science and Technology,
Environmental Affairs and Tourism, Health, Labour, and Trade and Industry who
has knowledge of the implications of GMOs for their respective Departments,
and any 2 other persons. The Council advises the Minister on all aspects
concerning the development, production, use, application and release of GMOs,
and ensures that such activities are performed in accordance with the
provisions of the Act
-
National advisory body: advises, on request or of its own accord,
the Minister, Executive Council, other Ministries and appropriate bodies on
matters concerning genetic modification of organisms. This includes advice on
all aspects relating to the introduction of GMOs into the environment and the
contained use of GMOs, and on proposals for specific activities or projects
concerning the genetic modification of organisms and the import and export of
GMOs, and advice on proposed guidelines. The Committee must also liaise
through relevant Departments, with international groups and organisations
concerned with biosafety. The Committee may invite written comments from
knowledgeable persons on any aspect that is within the Committee’s brief. The
Committee is to consist of no more than 10 persons appointed by the Minister
(on recommendation of the Council, and for a period not exceeding 5 years),
with no more than eight being knowledgeable persons in those fields of science
applicable to the development and release of GMOs, and two being from the
public sector with a knowledge of ecological matters and GMOs.
|
Research
|
-
No information available at this
time.
|
Other
|
The precautionary
principle
|
-
The
Precautionary Principle is not referred to in the Act
|
Cost recovery
|
-
There
is provision in the Act for regulations to provide for application fees. No
confirmation has been received at this stage regarding whether fees have been
prescribed.
|
Moratorium
|
|
SUMMARY
- Several pieces of legislation regulate GMOs:
- Federal
Plant Pest Act - 7 USC 7B;
- Federal
Insecticide, Fungicide, and Rodenticide Act - 7 USC 136;
- Federal
Food, Drug and Cosmetic Act - 21
USC 9;
- Toxic
Substances Control Act - 15 USC 53.
- The system requires permits to be issued by the relevant
regulatory authority. Depending
on the nature of the GMO, permits may be required from more than one
authority. In general:
- the
US Department of Agriculture Animal and Plant Health Inspection Service (APHIS) - has the broadest authority over transgenic plants and has
responsibility for determining whether such a plant poses a threat directly
or indirectly as a plant pest;
- the
US Environmental Protection Agency (EPA) regulates microbial and plant
pesticides, new uses of existing pesticides and novel microorganisms; and
- the
US Food and Drug Administration (FDA) is responsible for ensuring the safety
of all food (by enforcing tolerances in food set by EPA), feed, and human and
veterinary drugs.
-
There is no statutory link between each of the
regulators.
|
Contained work with GMOs
|
Responsible Agency
|
-
National
Institute of Health (NIH).
|
Legislation
|
-
There
is no special regulatory system for ensuring the safe use of biotechnology in
the laboratory or factory where the organism is not to be released into the
environment (ie: contained use).
Voluntary guidelines - the NIH’s Guidelines
for Research Involving Recombinant DNA Molecules - are implemented by
most users of the technology.
|
Intentional releases of GMOs in the
environment
|
Responsible agency
|
-
The US Department of Agriculture Animal and Plant Health
Inspection Service (for plant pests, plants and veterinary biologics).
-
The
U.S. Environmental Protection Agency (for microbial/plant pesticides, new
uses of existing pesticides and novel micro-organisms).
|
Legislation
|
-
Federal Plant Pest Act; and
-
Federal Insecticide, Fungicide and
Rodenticide Act
-
National Environment Protection Act
|
Coverage of the legislation
|
-
Field
testing, moving, importing and commercial release of organisms and products altered or produced
through genetic engineering which are plant pests or may become plant pests
-
‘Genetic
engineering’ is defined as the genetic modification of organisms by
recombinant DNA techniques. There is
no definition of ‘recombinant DNA techniques’.
|
Assessment process for intentional release of a GMO into the
environment
(field trials and general releases)
|
-
Developer submits data to the APHIS (notification to
APHIS of an environmental release must be at least 120 days prior to
release).
-
Data must demonstrate that the plant is safe to release
and is not itself a plant pest or potential noxious weed.
-
The APHIS conducts an assessment in accordance with the National Environmental Protection Act.
-
APHIS has a two tiered level of risk - lower risk GMOs
need only be notified to the agency, while other releases require a permit.
-
In
assessing an application for a permit, the APHIS:
- examines the results of any field trial
(field trial results must be submitted to APHIS within 6 months of the
termination of a field trial);
- must be satisfied that the benefits of the
proposal outweigh the costs;
- may require the preparation of an
environmental impact statement in addition to an environmental assessment;
- must seek public comment on a proposal if
a person has submitted to the APHIS a petition to seek a determination that a
particular GMO should not be regulated under the legislation. APHIS then makes a decision to approve the
petition in whole or in part, or to deny the petition; and
- must
consult Departments of Agriculture in the States where release is planned.
-
If the GMO is also a plant pesticide then EPA approval is
also required under the Federal
Insecticide, Fungicide and Rodenticide Act as pesticide is broadly defined to include
plants modified by biotechnology to resist disease. The EPA may also treat micro-organisms as
subject to the Toxic Substances Control
Act
-
A “determination of non-regulated” status is issued by APHIS
if the crop is not a plant pest allowing the crop to be released without
restriction. EPA would also issue
approval.
|
Consideration of ethical issues
|
-
The
only matter considered by APHIS is whether the plant is a plant pest or has
the potential to be a plant pest.
Ethics, trade and social issues are not taken into account.
|
Public consultation on applications
|
-
The
APHIS must only seek public comment on a proposal if a person has submitted
to the APHIS a petition to seek a determination that a particular GMO should
not be regulated under the legislation.
APHIS then makes a decision to approve the petition in whole or in
part, or to deny the petition.
|
Protection of confidential commercial information
|
-
Each
of the relevant pieces of legislation provide for the protection of
confidential commercial information.
-
Proponents
applying to APHIS for a permit must provide two copies of their application,
one with confidential business information passages marked and the other with
these passages removed.
|
Conditions that may be applied
|
-
APHIS
permits are subject to several conditions prescribed in the regulations,
including:
- Separation
of the GMO from other organisms;
- Treatment
of material accompanying the GMO;
- Compliance
with measures prescribed by APHIS which are necessary to prevent the
accidental or unauthorized release of the GMO;
- the
requirement that the GMO be subject to the application of remedial measures
determined by APHIS to be necessary to prevent the spread of plant pests;
- the
maintenance of the GMO only in the areas prescribed in the permit; and
- inspectors
must be allowed access, during regular business hours, to places where the
GMO is located, and to records relating to the introduction of the GMO.
-
In
addition, the permit holder can be subject to any other conditions APHIS
deems as necessary to prevent the dissemination and establishment of plant
pests. Permit can be withdrawn if
non-compliance with these conditions is identified.
|
Monitoring, surveillance and enforcement powers
|
-
Once
permission for the cultivation of a transgenic crop has been granted,
progress is monitored. The system does not rely on significant enforcement
powers as the regulatory system is based on ‘permits, testing and tolerance
setting’
|
Offences/Penalties
|
-
Violations
relating to plant pests can incur criminal or civil penalties.
-
Any
person who violates the regulations, or who forges or counterfeits any permit
can be punished criminally by a fine not exceeding $5000 or by imprisonment
not exceeding 1 year, or both. Such
violations may also be dealt with civilly with the maximum fine being $1000.
|
Liability for
contamination
|
-
There is no strict liability regime for
recovery by third parties; third parties must rely on the common law or
remedies available under general environment protection legislation.
|
Policy and Governance
issues
|
Committees
|
-
Information
about Committees is currently being clarified but there are no statutory
committees that examine GMOs specifically.
|
Research
|
-
Information about research is currently
being clarified but there is no statutory requirements for the Regulator to
undertake research on GMOs.
|
Other
|
The precautionary principle
|
-
The
legislation does not reference the Precautionary Principle.
|
Cost recovery
|
-
There
is capacity for some cost recovery - For example, permit applications carry a
charge but the services of inspectors
during regular assigned hours and at usual places of duty are furnished
without cost while overtime for inspectors does carry a cost.
|
Moratorium
|
|
SUMMARY
- Canada does not have a single piece of legislation that
regulates GMOs. Most of the legislation applicable to biotechnology
addresses specific product categories, and pertains both to biological
and non-biological processes and products.
- The main agencies involved in the regulation of GMOs are
Agriculture Canada, Environment Canada and Health and Welfare
Canada. The relevant legislation
includes:
- Canadian
Environment Protection Act 1999 (CEPA) (covers those uses not covered by
other legislation);
- Feeds
Act (feeds);
- Fertilisers
Act (supplements);
- Health
of Animals Act (veterinary biologics);
- Seeds
Act (plants with novel traits);
- Pest
Control Products Act (microbial pest control agents); and
- Food
and Drugs Act (drugs, cosmetics, medical devices, and novel foods).
- Environment Canada oversee all intentional releases of GMOs into
the environment and as such this summary will focus on this.
|
Contained work with GMOs
|
Type of regulation
|
-
Contained
research involving GMOs is not covered by the Environment Protection Act.
-
Laboratory
research in Canada is covered by the US NIH’s Guidelines for Research Involving Recombinant DNA Molecules.
|
Intentional releases of GMOs in the
environment
|
Responsible Agency
|
|
Legislation
|
-
Canadian
Environment Protection Act 1999 (CEPA).
|
Coverage of the legislation
|
-
Substances
that are new (ie not on the list of Domestic Substances) cannot be
manufactured or imported unless approval is granted from the Minister.
-
Substance
is defined as any distinguishable kind of organic or inorganic matter,
whether animate or inanimate, and includes any matter that is capable of
being dispersed in the environment or of being transformed in the environment
into matter that is capable of being so dispersed or that is capable of
causing such transformation in the environment. ‘Living organism’ is defined
as a substance that is an animate product of biotechnology.
|
Assessment process for intentional releases of a GMO into the
environment
(field trials and general releases)
|
-
The
Minister must be notified if someone wishes to manufacture or import a new
substance that is not on the Domestic Substances List (if it is on the list
no approval is necessary).
-
Information
relevant to the assessment must be provided to the Minister.
-
All
proposals undergo a single 60-day public consultation period where interested
parties may bring forward additional scientific evidence to support or refute
the Minister’s decision.
-
After
taking into account any advice provided, the Minister must decide whether the
substance is toxic or capable of becoming toxic.
-
If the
Minister decides that the organism is not toxic or capable of becoming toxic,
the Minister can place the organism on the Domestic Substance Register but
cannot impose any conditions.
- If the
Minister decides that the organism is toxic or capable of becoming toxic,
then the Minister can:
(a)
permit
its manufacture or importation subject to any conditions the Minister may
specify; or
(b)
can prohibit
its import or manufacture.
-
The
final decision of the Minister must be published.
|
Consideration of ethical issues
|
-
In
making a decision Ministers may only determine whether the substance is toxic
or capable of becoming toxic. Ethics, trade, social and other issues may not
be taken into account.
|
Public consultation on applications
|
-
All
proposals for release of a GMO into the environment undergo a single 60-day
public consultation period where interested parties may bring forward
additional scientific evidence to support or refute the Minister’s decision.
|
Protection of confidential commercial information
|
-
An
applicant may request that information be treated as confidential.
-
The
Minister must not disclose any information in respect of which a request for
confidentiality has been made unless:
- it
is in the public interest; or
- it
is disclosed under an agreement between the Government of Canada and any
other government of Canada or government of a foreign state etc and the
agency agrees to keep the information confidential.
|
Conditions that may be applied
|
-
Where
the Minister suspects that a living organism is toxic or capable of being
toxic, the Minister for the Environment may permit the manufacture or import
of the living organisms subject to any conditions that the Minister may
specify.
|
Monitoring, surveillance and enforcement powers
|
-
Enforcement
officers may be appointed under the CEPA.
-
Enforcement
officers have the power to enter and inspect premises where a substance can
be found, for the purposes of the Act. Officers have been given wide powers
of inspection, including opening receptacles and packages, examining records,
taking samples and conducting tests. CEPA also allows officers to act without
warrants in emergencies. Officers may seize or detain anything which caused a
contravention to occur, or which will provide evidence of the contravention,
however they can only do so if it is required for evidence, analysis or it is
in the public interest to do so.
-
Officers
may also issue environmental protection compliance orders to owners and
managers and persons contributing to contraventions which must be complied
with (orders can include reporting requirements, and to cease operating).
|
Penalties
|
-
A
maximum fine of $1,000,000 or a prison term of 3 years exists (if convicted
on indictment) for persons who contravene a provision of the Act or
regulations, an order or direction under the Act or an obligation or a
prohibition arising from the Act or regulations, or who knowingly provide
false or misleading information.
-
For
summary conviction it is $300,000 or 6 months.
-
If, in
committing the offence, a person intentionally or recklessly causes a
disaster that results in loss of the use of the environment, or shows wanton
disregard for the lives or safety of other persons and thereby causes a risk
of death or harm to another person, the maximum prison term increases to 5
years and there can be an unlimited fine imposed.
-
Each
day the offence is committed is a separate offence. The CEPA also sets down criteria which the
Court must look at when sentencing, including harm caused, the costs of any
remedy actions, intention, and any property, benefit or advantage to the
offender.
-
Despite
the maximum amount of any fine under the legislation, a court may impose an
additional fine equal to the court’s estimation of the amount of property,
benefit or advantage derived by the offender from their actions. Instead of
convicting an offender, or in addition to other punishments, a court may make
an order requiring the offender to do or refrain from doing certain action
(eg: requiring the offender to take any action to remedy or avoid harm,
prepare and implement a pollution prevention plan, carry out environmental
effects monitoring, compensate the Minister, pay an amount to environmental,
health or other groups or to scholarships for students enrolled in
environmental studies, or publish the facts relating to the incident).
|
Liability for contamination
|
The CEPA provides for
two types of action:
(1) Environmental
Protection Actions.
Any Canadian citizen can
apply for an investigation of an alleged offence in contravention of the
legislation - this is called an “Environmental Protection Action” (EPA). An EPA can only be bought if:
(a) the Ministers
investigation was inadequate or non-existent; and
(b) there was an alleged
breach of the Act; and
(c) the alleged breach is
causing significant harm to the environment.
An EPA may not be bought
if the alleged conduct was:
(a) taken to correct or
mitigate harm or risk of harm to the environment or human plant or animal
life;
(b) taken to protect
national security; or
(c) was reasonable and
consistent with public safety.
Defences to an EPA
include:
(a) due diligence;
(b) authorisation by another
act of parliament;
(c) an officially induced
mistake of law; and
(d) any other defences
available under general law.
In addition, an action
may be dismissed if it is not in the public interest. The only relief that is available if an EPA
is successful is an injunction (stopping the defendant from doing something
or forcing them to do something) or an order to the parties to negotiate a
plan to correct or mitigate the harm to the environment etc, costs of the
action. There can be no award of damages in the event of a successful EPA.
This action does not
assist individuals effected by contamination to seek damages for loss
suffered; rather it enables them to bring an action if there has been a
breach of the Act, to stop the activity continuing.
(2) Common law actions
The Act explicitly
reiterates the common law right for a third party who has suffered damage to
go to court to seek damages for such loss. The action that may be brought (and the damages able to be recovered)
will depend entirely on the application of ordinary principles of law (nuisance,
negligence etc). The Canadian Environment Protection Act does not establish
any statutory right to recover for loss or damage or any strict liability
regime. At the time of preparing this document, no successful actions for
contamination have been brought under common law in Canada.
|
Policy and Governance issues
|
Committees
|
-
Canadian Biotechnology Advisory Committee
(CBAC): is a non-statutory
committee established by the
federal government to provide advice to a Coordinating Committee of federal
ministers on broad policy issues associated with the ethical, social,
regulatory, economic, scientific, environmental and health aspects of
biotechnology. CBAC is made up of 21 members drawn from the scientific,
business, general public, ethics and environmental communities.
-
The
CEPA establishes a National Advisory
Committee that can provide both technical and policy advice to the
Minister on:
- proposed regulations for toxic
substances;
- proposed regulations on environmental
emergencies;
- a co-operative coordinated approach to
the management of toxic substances; and
- any other matter or mutual interest.
-
This
Committee looks at all environmental issues not just biotechnology.
|
Research
|
-
The
Minister for the Environment and Minister for Health must both undertake
research and studies into environmental contamination arising from
disturbances of ecosystems by human activity, and the role of substances in
illnesses or health problems, respectively.
|
Other
|
The precautionary principle
|
-
The
preamble to CEPA states that ‘whereas the Government of Canada is committed
to implementing the precautionary principle that, where there are threats of
serious or irreversible damage, lack of full scientific certainty shall not
be used as a reason for postponing cost-effective measures to prevent
environmental damage.
|
Cost recovery
|
-
Fees
are attached to notifications to CEPA. The Canadian Government may also
recover all costs of, and incidental to, taking reasonable measures to
prevent releases that endanger the environment and public safety, or to
remedy any dangerous situation or reduce or mitigate any danger to the
environment or to human life that results, or may result, from the release of
a toxic substance in breach of conditions (although there is a 5 year
limitation period).
|
Moratorium
|
|