Saturday, April 27, 2024

Our gene tech laws lack clarity

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Gaps, ambiguities and complexities in legislation need clarity for researchers and companies before they can come to grips with opportunities presented by new gene-editing technology, Otago University expert Dr Julie Everett-Hincks says.
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Everett-Hincks, a legal and scientific researcher at Otago University and legal adviser to the Royal Society gene editing panel outlined at a seminar last week in Hamilton some of the pitfalls facing GE research.

The series of seminars is being hosted by the society after its third report on GE, the latest examining its role in the primary sector.

The report outlined some advantages the technology could deliver, including removing an allergen from cows’ milk and producing disease-resistant manuka, faster apple breeding and sterile wilding pines.

Everett-Hincks said apple example is a challenge to existing legislation because the technique involves inserting gene-editing machinery into a cell in containment to enable the apple to flower more often so new varieties can be developed more quickly. 

The machinery can then be removed before the new variety is commercialised and released, effectively making it a traditional apple plant, free of GE technology.

“But according to the Hazardous Substances and New Organisms (HSNO) Act it is likely to be defined as a genetically modified organism.”

In light of such modern techniques, the most contentious aspect of HSNO’s GM regulations allows modification using radiation and chemical mutations that were in use on or before July 29 1998.

“Simplistically, any technique used after that date, that is not covered by the Act or its regulations, is genetic modification.” 

Researchers had hoped Scion’s GM pine trial in 2011 would provide a legal path to allowing newer techniques when the Environmental Protection Authority approved a variation of the older gene-editing methods to be used in trial pines.

But the High Court ruled against such an interpretation.

When modification is applied to animals, such as the removal of the allergen from cows’ milk, the issues become even more complex.

“With animals you have to consider the Animal Welfare Act. 

“Manipulation of the animal includes exposing it to a biological product and this includes using genetic modification that may result in the birth or production of an animal more susceptible or at greater risk of pain or distress as a result.”

However, she noted the Animal Welfare Act does not define genetic modification and researchers in general cannot refer to other Acts when seeking clarity and definition. 

“And there is also a challenge on all animal products that come from the dairy cow, including meat, hides, not just its progeny.”

Similarly, the Agricultural Compounds and Veterinary Medicines Act also fails to define biological compounds used for the direct management of plants and animals, leaving some ambiguity about how gene-editing fits within that.

Everett-Hincks said the five examples the society chose in its latest report are all regarded as GM and thus new organisms under existing regulations.

New Zealand is also likely to face some ambiguities about the Cartagena Protocol, an international agreement NZ is a signatory to that ensures the safe transfer and handling of living modified organisms across borders.

“But not every country is a signatory to this agreement. Canada and Australia are a party to it but not signed to it while the United States has no interest in it.

“This is something we need to think about in relation to future trade of products that could be genetically edited or modified.”

Not only are international border issues likely to become contentious, the Resource Management Act means councils can prohibit GM crops.

“But how do you determine what is a crop – does it include forests and ryegrasses. Crop demands better definition and there will be boundary issues within NZ between councils also.

“And if these issues were not complicated enough, there are many acts and regulatory authorities engaged around GM, making its application for approval and release highly complex.”

Australia has a dedicated gene technology law that is subject to five yearly reviews, with one under way now.

Some countries are also more product than process focused when it comes to application of gene-editing technology.

The United States, for example, has recently approved gene-editing technology for some foods, focusing solely on the safety of the food it produces, rather than the process to produce that food.

“These are all areas of genetic editing that demand we have an open, honest, inclusive and rigorous debate about what is genetic editing and genetic modification in NZ.”

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