An expert panel has suggested New Zealand’s regulations surrounding gene technology are well past their use-by date and it’s time for a rewrite.
Advances in gene technology have left the regulations surrounding its use in New Zealand far behind.
New Zealand’s rules about genetic modification were made back in 2001, when phones didn’t have cameras and social media didn’t exist.
For genetic science, CRISPR-Cas9 was just a glimmer in scientist’s eyes.
Short for the incredibly non-catchy “clustered regularly interspaced short palindromic repeats”, CRISPR-Cas9 allows for precision editing of genomes, without the insertion of material from a different species which contributed to the term ‘frankenfood’.
It has opened up a world of possibilities for science ranging from treating cancer, to modifying plants, or eradicating pests.
Alongside enthusiasm there’s also been outrage. When the Chinese scientist He Jiankui announced he had edited the genomes of twin girls, public and scientific backlash was swift. China said his work was a clear violation of rules, however, some have described China’s regulations as vague.
As part of a series on gene editing, The Royal Society Te Apārangi’s Gene Editing Panel has produced a paper looking at whether New Zealand’s regulatory framework is still fit for purpose.
A summary of the key points in the society’s paper follows:
Murky definitions and a regulatory fruit salad
A key part of regulating something is defining what you are regulating, and making sure people are talking about the same thing. The panel found definitions in regulation are no longer fit for purpose.
The Hazardous Substances and New Organisms (HSNO) Act defines organisms as either genetically modified, or not genetically modified. To be genetically modified the genes need to have been modified or derived from something made “in vitro” – a laboratory vessel.
Science has advanced to the point where CRISPR can be applied in living cells, not in a laboratory vessel. The current definition in the main piece of legislation created to regulate gene technology doesn’t reflect where science is at.
Other legislation could also come into play when making decisions around the release of a genetically-edited organism, but because much of the legislation was written before the science, it’s a bit like trying to jam a square peg into a round hole.
There’s no clear pathway. If the eradication of possums were to be attempted using gene-drive technology, the report notes 10 different pieces of legislation could come into play and these also have terms which aren’t clearly defined.
The panel suggests instead of a black and white definition, gene technology exists on a continuum, and a conversation should be had with the public regarding preferences for use of new technologies.
It also suggests a tidy up to the range of definitions across the regulatory system as well as clear pathways for making decisions.
An island in a connected world
If New Zealand is an outlier in regulations, trade prospects could be impacted. The European Union has decided genetically-edited crops are to be treated the same strict way as genetically-modified crops.
Australia has a more lax approach, and has exempted some gene editing, suggesting the results can’t be distinguished from conventionally bred animals and plants.
For import there’s another wrinkle. If gene-edited foods are banned, there’s no easy way to manage this. Changes made by gene editing can be exactly the same as changes caused by naturally-occurring mutations. Telling the difference could be incredibly difficult.
Is how it’s made more important?
CRISPR can be used to generate the same outcomes as chemical or radiation mutagenesis. Under current rules the product of mutagenisis gets a free pass, while the same thing produced using CRISPR would need to be checked for safety.
The debate over process versus outcome is one ongoing in other countries.
The panel’s view is New Zealand’s process-based system is becoming obsolete, and suggests a risk-tiered approach where the regulatory burden reflects the risk.
What do people think?
Repeated throughout the panel’s report is the need for community involvement. What are people comfortable with? How does the Treaty of Waitangi impact decisions around gene technologies?
The panel notes informed discussion is key:
“The panel’s view is that there is wide disparity in community understanding of new genetic technologies and applications and, for many, the potential applications of the technologies is moving ahead of their understanding.”
With previous public conversations on the topic heated, there have been calls for a constructive discussion. In its previous papers the panel noted a range of public acceptance of genetic technology.
Its potential for use in healthcare was most positively-viewed as long as negative side-effects could be ruled out.
Using gene-drives for pest control was less popular. The panel notes there is some appetite if benefits outweigh risks, but concerns gene-edited pests could find their way to their home countries.
Using gene-editing technology in primary industries was viewed as a way to maintain a competitive advantage, although some felt a GM Free status is itself a competitive advantage.
Royal Society Te Apārangi president professor Wendy Larner said the project has been important for the society.
“This work was needed to urgently inform an important national conversation about gene editing as its global development continues apace. There is a real risk of New Zealand communities being left behind. Royal Society Te Apārangi was arguably the best-placed organisation in the country to do this work given its independence and its access to the best expertise across New Zealand and globally. I am hopeful that the resources developed by this panel will be helpful to communities and the Government in informing New Zealand’s future direction.”