Who is involved?

Environmental Risk Management Authority of New Zealand
Food Standards Australia New Zealand (FSANZ)
Health Research Council (HRC)
Medicines and Medical Devices Safety Authority (Medsafe)
Ministry of Agriculture and Forestry Biosecurity New Zealand (MAF BNZ)
Ministry for the Environment (MfE)
Ministry of Health (MoH)
Ministry of Research, Science and Technology (MoRST)
The New Zealand Food Safety Authority (NZFSA)

Environmental Risk Management Authority of New Zealand

This is the government agency responsible for assessing and approving hazardous substances and new organisms (including GMOs) in New Zealand.

The Environmental Risk Management Authority of New Zealand is made up of:

The Authority is the decision-making body and consists of up to eight members appointed by the Minister for the Environment. Members of the Authority must have a balanced mix of knowledge and experience in matters likely to come before the Authority. Members have a range of skills - scientific or technical (such as genetics, ecology, chemistry, medicine), legal, Māori tikanga - and are appointed for varying terms, usually between 2 and 5 years.

Ngā Kaihautū Tikanga Taiao can consist of up to 8 members and is appointed by the Authority. It advises the Authority on:

The Agency (referred to here as ERMA New Zealand) carries out operations in support of or on behalf of the Authority. For example, they handle queries from researchers and others, receive and manage applications, produce evaluation and review reports on applications to assist the Authority with their decision-making, and are involved in compliance and enforcement activities. The Agency also develops guidelines and other publications, and provides support to Ngā Kaihautū Tikanga Taiao.

In addition, ERMA New Zealand has established an ethics advisory panel and a panel of science experts that it can call upon for advice on applications.

Food Standards Australia New Zealand (FSANZ).

FSANZ is the agency responsible for developing food standards and approving foods for commercial use in Australia and New Zealand. They undertake scientific risk assessments of foods before giving pre-market clearance. They can be contacted 0800 441 571 or by e-mail at info@foodstandards.gov.au. They have offices in Australia and New Zealand.

Health Research Council (HRC)

If humans are part of the research, or cells, tissue or other samples are taken directly from humans, then approval from a human ethics committee is required. The Health Research Council has responsibility for providing guidelines for ethical research and accrediting ethics committees, while the Ministry of Health has oversight of the regional and multi-regional ethics committees.

For human clinical trials then assessment by the Standing Committee of Therapeutic Trials (SCOTT) and/or the Gene Technology Advisory Committee (GTAC) are also required. These committees are also managed by the HRC.

The HRC Ethics Committee has responsibility for providing guidelines to researchers on ethics in research and approving ethics committees to review HRC funded research and for the purposes of the Injury Prevention, Rehabilitation and Compensation Act 2001.

Medicines and Medical Devices Safety Authority (Medsafe)

Medsafe has responsibility for managing the assessment and surveillance of medicines and medical devices in New Zealand. More information is available in the Medicines section of the Regulatory Wayfinder.

Note that subsidisation of medicines is managed by the pharmaceutical management agency (Pharmac). Medsafe and Pharmac work independently, and Medsafe is not involved in funding issues.

Ministry of Agriculture and Forestry Biosecurity New Zealand (MAF BNZ)

Enforcement and compliance monitoring associated with the new organisms component of HSNO Act approvals are usually carried out by the Ministry of Agriculture and New Zealand Biosecurity New Zealand. MAF BNZ also has responsibility for developing Import Health Standards and issuing import permits.

If animals are involved in research, testing or teaching then MAF's Animal Welfare Group have oversight, along with the National Animal Ethics Advisory Committee, and the National Animal Welfare Advisory Committee.

The Animal Welfare Group of MAF BNZ develops science-based animal welfare policy and standards, identifies emerging animal welfare issues and research priorities, liaises with New Zealand and international agencies involved in animal welfare, and develops a New Zealand position in relation to animal welfare and international trade. The group also provides secretariat support and advice for two Ministerial advisory committees:

Members of both committees are appointed by the Minister of Agriculture and are required to encompass a range of scientific, industry, and welfare expertise.

The National Animal Ethics Advisory Committee has a major role in overseeing the use of animals in research, testing, and teaching. It reviews codes of ethical conduct and makes recommendations as to whether codes should be approved by the Director-General of MAF.

In its annual report this committee reports on the numbers and types of animals used for research, testing and teaching in New Zealand. The annual report is available on the Biosecurity New Zealand website.

The National Animal Welfare Advisory Committee has a focus on animal welfare associated with farm, wild, and domestic animals. It develops codes of welfare, reviews codes of welfare drafted by others, considers submissions made on draft codes during the public consultation process and makes recommendations to the Minister of Agriculture on whether a particular code should be issued.

More information on both these Committees can be found on Biosecurity New Zealand's website, where there are also links to other animal welfare societies and organisations.

Ministry for the Environment (MfE)

While the Environmental Risk Management Authority is the regulatory agency for the HSNO Act, MfE is the government department responsible for HSNO Act policy. MfE also advise the government on New Zealand's other environmental laws, policies, standards and guidelines, monitor how they are working in practice, and take any action needed to improve them. This Ministry reports on the state of the environment, on local government performance on environmental matters, and on the work of the Environmental Risk Management Authority and the Energy Efficiency and Conservation Authority.

Ministry of Health (MoH)

The Ministry of Health is the government's principal agent and advisor on health and disability. It develops policy advice for the Government on health and disability issues, administers health regulations and legislation, funds health and disability support services, plans and maintains nationwide frameworks and specifications of services, monitors sector performance and provides information to the wider health and disability sector and the public. Medsafe is a business unit of the Ministry.

Health and disability ethics committees were established by the Minister of Health under the New Zealand Public Health and Disability Act 2000 to consider applications for research involving humans. These committees (six regional and one multi-regional) provide ethical assessment of, among other things, the use of humans in research and the collection and use of human tissues. The Ministry of Health is involved with health and disability ethics committees in an administrative capacity. It employs the committee Administrators and the National Co-ordinator of Ethics Committees and provides other administrative resources for the committees. The Ministry of Health has no input into these ethics committees and does not comment on individual research applications. More information is available on the Health and Disability Ethics Committees website.

The National Ethics Advisory Committee is responsible for determining nationally consistent ethical standards across the health sector and for providing scrutiny for national health research and health services. NEAC is also responsible for providing advice to the Minister of Health on ethical issues of national significance in respect of any health and disability matters.

The Ministry of Health has also established advisory and ethics committees to provide advice to the Minister and ethical oversight for assisted human reproductive technologies and human reproductive research. More information is available on the Advisory Committee on Assisted Reproductive Technology (ACART) and Ethics Committee on Assisted Reproductive Technology (ECART) websites.

Ministry of Research, Science and Technology (MoRST)

The Ministry of Research, Science & Technology (MoRST) is the New Zealand government department which develops research and innovation policies and manages the publicly funded part of the Research, Science and Technology system on behalf of the Government. MoRST is a policy agency, while the Foundation for Research, Science and Technology is a separate government agency that provides funding for some of the research undertaken in New Zealand.

MoRST is involved in implementing many aspects of the government's Biotechnology Strategy. The Regulatory Wayfinder is one result of the work associated with this strategy. More information on the Biotechnology Strategy and MoRST's work in this area is available on the Biotechnology page of MoRST's website.

The New Zealand Food Safety Authority (NZFSA)

In New Zealand the NZFSA is responsible for day to day assessment and regulation of food safety. NZFSA manages food-related risks from the "farmgate to the consumer's plate". NZFSA is the New Zealand controlling authority for imports and exports of food and food related products.

The ACVM Group of the NZFSA has responsibility for the registration of agricultural compounds and veterinary medicines.

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