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Government decisions: Research and controls in containment

Simplifying approval processes for laboratory GM research

Noted the Royal Commission’s Recommendations 6.1-6.5, 6.7 and 6.11 comprise a suite of seven recommendations that aim to simplify the approval process for low-risk laboratory based GM research, without changing the scope of the low-risk research that can be permitted.

6.1 Assessment of low risk applications for research on a project basis.

Agreed to accept the intent of Recommendation 6.1, which is to simplify the assessment of low-risk laboratory GM research either by using defined criteria to assess organisms, or by providing for the approval of groups of organisms of similar types and risks, rather than requiring separate approvals for each organism.

Directed officials to report back to POL by the end of February 2002 on the actions required to implement the intent of this recommendation.

6.2 Review of approval forms, standards and regulations for GMOs

Agreed to accept the intent of Recommendation 6.2 which is to ensure that administrative and regulatory processes are kept up to date, are appropriate, and are able to respond to new developments in GM technology.

Directed officials to report to POL by the end of February 2002 on any remaining actions required to implement Recommendation 6.2.

6.3 New form for low-risk applications to IBSCs

Noted the ERMA is currently reviewing the format and information requirements in the application form for low risk laboratory developments and that the review will be completed by the end of November 2001.

Agreed to accept Recommendation 6.3, and that no further action is required.

6.4 Amend the HSNO Act to allow IBSCs to approve imports of low-risk GMOs

Agreed to accept Recommendation 6.4.

Directed officials to report to POL by the end of February 2002 on the actions required to implement Recommendation 6.4.

6.5 ERMA approvals of GMOs to cover holding and breeding

Agreed to accept the intent of Recommendation 6.5, which is to ensure that low risk GMOs are all held with appropriate legal approvals, and that no action is required, as remaining issues are being resolved by the ERMA.

6.7 Delegate development of GM animal cell lines to IBSCs

Agreed to accept the intent of Recommendation 6.7, which is to delegate authority to IBSCs for appropriate low risk developments involving animal cell lines, and that this issue will be addressed in the amendment to the low-risk regulations proposed in the response to Recommendation 6.1.

6.11 Fund research portfolios to include HSNO application costs

Noted that the agencies that fund public good research portfolios all operate with a policy to “fully fund” the costs of research, i.e. that compliance costs are already built into the funding of research portfolios.

Noted that as the costs of making applications increases the amount of research that can be undertaken decreases correspondingly.

Noted that the implementation of Recommendations 6.1 - 6.5 will also assist to reduce the costs of making applications for low risk laboratory research.

Gaps in HSNO Act coverage

Noted further policy work is needed to determine the most appropriate mechanism to resolve the current gap in regulation of GM cell lines and tissue cultures.

6.6 Amend the HSNO Act to cover genetic modification of human cell lines or tissue culture

Agreed to accept the intent of Recommendation 6.6 which is to ensure that the GM of human cell lines and tissue cultures is subject to appropriate regulation.

Directed officials to report to POL by the end of February 2002 on the actions required to implement the intent of the recommendation.

6.9 Amend the HSNO Act to cover procedures used in mammalian cloning

Agreed to accept the intent of Recommendation 6.9, to the extent that it ensures that new species of mammals (or other animals) cannot be imported as tissues and subsequently regenerated by cloning and released without an appropriate HSNO Act approval.

Directed officials to report to POL by the end of February 2002 on the actions required to implement the intent of the recommendation.

Ethical and cultural issues related to GM

6.10 To include at least one Māori member on Institutional Biological Safety Committees.

Agreed to accept Recommendation 6.10 which is to ensure appropriate Māori input into the decisions made by IBSCs.

7.5 Use non-food animals as bioreactors to produce human proteins

Agreed to accept the intent of Recommendation 7.5, which is to ensure that GM animals and animal products do not enter the food chain unintentionally and that no further action is required.

7.6 Use of alternatives to human genes in transgenic mammals

Agreed to accept the intent of Recommendation 7.6 and that the proposed Toi te Taiao: the Bioethics Council (Recommendation 14.2) could address the ethical issues raised by this recommendation.

Last updated: 24 February 2009