Appendix Three

Appendix Three

Regulation of gene technology - international comparisons

Document provided by the IOGTR

Regulation of Gene Technology in the

European Community

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:
  • In relation to GM products, there are also a number of relevant directives:

Contained work with GMOs

Responsible agency

Legislation

Intentional releases of GMOs in the environment

Responsible agency

Legislation

Coverage of the legislation

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

Consideration of ethical issues

Public consultation on applications

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Penalties

Liability for contamination

Policy and Governance issues

Expert Committees

Research

Not applicable

Other

The precautionary principle

Cost recovery

Moratorium

Other

Regulation of Gene Technology in the

United Kingdom

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:
  • There appears to be no statutory requirements for an interface between the regulation of GMOs and GM products.

Contained work with GMOs

Responsible Agency

Legislation

 

Intentional releases of GMOs in the environment

Responsible agency

Legislation

Coverage of legislation

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

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

Public consultation on applications

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Penalties

Liability for contamination

Policy and Governance issues

Expert Committees

Research

DETR contracts out specific research projects investigating the risks associated with GMOs.

Other

The precautionary principle

Cost recovery

Moratorium

Regulation of Gene Technology in Germany

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

Legislation

Coverage of the legislation

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

Consideration of ethical issues

Consultation on applications

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Penalties

Liability for contamination

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.

Research

No information available at this time.

Other

The precautionary principle

Cost recovery

Moratorium

Regulation of Gene Technology in New Zealand

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

Legislation

Coverage of the legislation

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

For release of GMOs into the environment

For low risk contained work

Consideration of ethical issues

Public consultation on applications

Protection of confidential commercial information

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Offences/Penalties

Liability for contamination

Policy and Governance issues

Expert Committees

Research undertaken by Regulator

It is not a statutory function of ERMA to conduct, or commission, research.

Other

The precautionary principle

Cost recovery

Moratorium

Regulation of Gene Technology in Japan

SUMMARY

  • Controls on gene technology are essentially voluntary and different aspects of gene technology are overseen by different portfolios:
  • 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

Guidelines (no legislation)

Voluntary guidelines:

For intentional releases of GMOs in the environment

Responsible agency

Guidelines (no legislation)

Coverage of the guidelines

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

Consideration of ethical issues

Public consultation on applications

Protection of confidential commercial information

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Penalties

Liability for contamination

Policy and Governance issues

Expert Committees

Research undertaken by the Regulator

Other

The precautionary principle

Cost recovery

Moratorium

Regulation of Gene Technology in South Africa

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

Legislation

Coverage of the legislation

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

Consideration of ethical issues

Public consultation on applications

Protection of confidential commercial information

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Penalties

Liability for contamination

Policy and Governance issues

Expert Committees

Research

Other

The precautionary principle

Cost recovery

Moratorium

Regulation of Gene Technology in the United States

SUMMARY

  • Several pieces of legislation regulate GMOs:
  • 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:
  • There is no statutory link between each of the regulators.

Contained work with GMOs

Responsible Agency

Legislation

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

Legislation

Coverage of the legislation

Assessment process for intentional release of a GMO into the environment

(field trials and general releases)

Consideration of ethical issues

Public consultation on applications

Protection of confidential commercial information

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Offences/Penalties

Liability for contamination

Policy and Governance issues

Committees

Research

Other

The precautionary principle

Cost recovery

Moratorium

Regulation of Gene Technology in Canada

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:
  • 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

Intentional releases of GMOs in the environment

Responsible Agency

Legislation

Coverage of the legislation

Assessment process for intentional releases of a GMO into the environment

(field trials and general releases)

Consideration of ethical issues

Public consultation on applications

Protection of confidential commercial information

Conditions that may be applied

Monitoring, surveillance and enforcement powers

Penalties

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

Research

Other

The precautionary principle

Cost recovery

Moratorium