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gloved hands holding a petri dish with plant samples against a red background dotted with blue dna helices
Photo: Getty Images; additional design The Spinoff

OPINIONScienceAugust 29, 2024

Let’s cut the crap on gene technology

gloved hands holding a petri dish with plant samples against a red background dotted with blue dna helices
Photo: Getty Images; additional design The Spinoff

Society should be asking itself why it needs to trade the security of its regulations for unsecured promises from the visions of genetic engineers, argues molecular biologist Jack Heinemann.

The government has proposed to reset and to remove some regulations on making and releasing genetically modified organisms (GMOs). Is it a new conversation based on a new risk equation, or an ultimatum?

The argument, after all, sounds familiar. Advocates for regulatory reform were saying more than 15 years ago what they are saying again now, that we can change the name of some products to make them sound less like GMOs

Are science minister Judith Collins’ reforms based on risk or persuasion? Society should be asking itself why it needs to trade the security of its regulations for unsecured promises from the visions of genetic engineers (including me). 

Here are what I consider to be four fictions about GMO regulations that I believe undermine public confidence in choosing the right regulations for New Zealand.

 1. Gene editing is different to genetic modification

According to Tony Conner of AgResearch, “Gene editing is different to genetic modification, in that this may only involve making a change to the genome, as opposed to introducing DNA from another organism.’

Redefining GMOs this way distorts public and lawmaker perceptions and undermines society’s control of biotechnology risks.

According to the US Food & Drug Administration, “A GMO (genetically modified organism) is a plant, animal, or microorganism that has had its genetic material (DNA) changed using technology that generally involves the specific modification of DNA, including the transfer of specific DNA from one organism to another. Scientists often refer to this process as genetic engineering.”

GMOs are defined as organisms with a novel combination of genetic material created using gene technology. This can be done by adding (eg transgenes), changing or removing (eg null segregants) DNA sequences to create novel combinations and new traits. 

A genome is more than an alphabet of the four letters A, G, C, T. As with language, it has grammar, syntax and semantics that govern the meaning of genes. Alleles are variants of genes that can be like homographs and homophones. All of these features can be manipulated by gene technology just as they can be in language.

Suggesting that GMOs are only organisms with added DNA lures the government into thinking there is a class of “low-risk gene-editing activities” when they’re not used to add DNA, and these “can be exempted from regulations”.

Even if that were true, it may be impossible to avoid adding DNA when using gene editing.

Gene-editing techniques have been used to make GMOs since the 1970s. What has changed is developments in gene editing that increase the efficiency of making desired DNA changes. The new tools make GMOs faster. Gene-editing techniques accelerate the rate of genetic change, but not safety. There is no limit to the variation that can be introduced through gene editing.

2. We’re missing out

Why hyberbolise regulations as a GMO ban? Is it to deceive us into thinking that only a ban could explain why we don’t use them?

The United States provides the counterfactual. It has the most permissive laws and largest number of commercialised GMOs.

Yet it has only commercialised 11 GM crops in 30 years. Nearly all GM production is just three crops – corn, soy and cotton – and two traits, herbicide-tolerant and insecticide-producing. GMO agriculture is used on ~15% of US agricultural land, with other GM organisms and traits contributing ~1%.

We have missed out on crop losses to dicamba drift and glyphosate-resistant weeds, but not access to drought-, heat-, flood- or salt-tolerant intrinsically higher-yielding crops.

Gene editing is no more inclined to deliver solutions to the big problems we face from climate change, malnutrition and poverty. Even those who support the legislative changes admit that “new cultivars created overseas” using new tools like gene editing “haven’t hit the market yet” even in permissive countries. Two products, a modified oilseed and a hornless cow, appeared then disappeared.

The story is similar for medicine. Research elsewhere has not found that regulations significantly slowed research and development of medicines. Removing GM requirements on laboratories or procedures would have negligible effect because they are redundant with other regulations and good laboratory practices for medicines research.

A mythical ban hasn’t kept GMOs away. Lack of useful or significant benefits to New Zealand may have. 

3. The current regulations focus solely on the methods

Earlier this year, science minister Judith Collins said “the new rules will be based on managing the risks of these technologies, rather than focusing solely on the methods of genetic modification”.

No regulatory framework focuses solely on methods. Is misleading rhetoric to the contrary behind proposals to deregulate some methods so that some products are exempt from risk assessment?

All countries with regulations use a combination of methods and product, including us, Australia and the US. The Convention on Biological Diversity and our domestic legislation were written using scientists who were aware of gene editing and its potential to cause harm to the environment or human health.

Our current regulations require case-by-case risk assessment, making them fit-for-purpose right now. Removing risk assessment decreases safety. Gene editing efficiency gains amplify latent hazards that emerge during manufacture. 

Furthermore, manufacturers should not police themselves. For example, the company that used gene editing to engineer hornless cows confidently asserted that no new DNA was introduced during the process. That claim was ignominiously retracted when regulators found undisclosed DNA inserted in the cattle genome, including entire antibiotic resistance genes from bacteria.

4. All high-risk activity will be regulated 

According to MBIE, “We will regulate higher-risk activities and exclude some low-risk gene-editing activities from regulation.”

Deregulation doesn’t just make it easier to release GMOs from the laboratory, it also would encourage making them outside of laboratories. Environment-scale, mechanised genetic engineering done in the out-of-doors (eg aerial spraying) is a high-risk activity that may become unregulated.

Genetic engineering used to require expensive laboratories, but no longer. The efficiencies of gene-editing and gene-silencing methods increase the scale of genetic engineering from laboratory table to the forest floor. 

GMOs made using deregulated methods will be unregulated even if made outside. Some likely outdoor products will be gene-editing pesticides and formulations that alter plant stress response as they grow.

Outdoor use will result in unintended exposures and unknown off-target genetic changes in non-target species. These range from microorganisms to pets.

Ecosystems from home gardens to forests could soon be “sprayed” with gene editors. If these products qualify as low-risk uses of gene editing, then neither the intended target organism nor all the possible exposed non-target organisms need be assessed for potential to cause harm.

In sum, faster ≠ safer, deregulation ≠ benefit, deregulation ≠ safety, and scale ≠ safety. The changes call on the public to renounce control over managing the risks from gene technology in exchange for no verifiable evidence of harm from existing regulations and repeating hypothetical benefits from 40-year-old promises.

Gaslighting the public in this way may damage industry and research reputations. The reform proposal could trade sector credibility for a quick sale.

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Getty Images; additional design The Spinoff
Getty Images; additional design The Spinoff

ScienceAugust 16, 2024

It’s time to put the ‘taking sides’ GM debates of the 90s behind us

Getty Images; additional design The Spinoff
Getty Images; additional design The Spinoff

A lot has changed since the GE free movement’s heyday, and with law reform coming, DNA expert Mike Bunce hopes New Zealand is ready to have a mature discussion about the role gene technologies can play in our society.

In the late 90s I had just completed a university degree in genetics. A polarising debate was kicking off on genetically modified organisms (GMOs). Are they good, are they bad? Please choose a side. 

The internet was gaining traction in the 90s too. Is it good or is it bad? 

The question is equally valid as, like gene technology, your answer will depend on the application(s) you are asked to consider. 

In the late 90s I left New Zealand as I wanted to use DNA tools in my research, but the rules that were coming into effect were very restrictive. Some called it precautionary, but to me it more closely resembled prohibition. Rather than stay in New Zealand and make DNA moonshine, I decided to move across the ditch.

Back in New Zealand, and two decades later, I am closely watching the public debate as dialogue kicks off on the gene technology bill announced this week. As we revisit this topic, I hope we have learnt that this is not a binary “good or bad” decision where we have to choose a side. 

We need to collectively take a ride to the DNA side and make some informed decisions on the rules, regulation and risk. It may not be an easy ride, but it’s one worth taking.

Let’s backtrack a little 

Every living species – including you – is forged from a DNA blueprint. It fills our cells and the food we eat. In addition to food varieties that we have genetically bred into existence, we also rely on DNA “tech” for diagnostic tests (remember the PCR tests during the pandemic?), vaccines, forensics, medicines like insulin, and DNA-based ancestry. Why, then, don’t we pay closer attention to how our lives, food, families and wellbeing are intrinsically interwoven within the two helices of DNA? 

We accept some technologies into our lives without blinking. Others we resist and rarely talk about. Why then do DNA technologies, even on the back of RNA vaccines that saved millions of lives, always seem to sit in the latter category? 

It bothers me as this is foundational and important stuff. It is unhealthy not to talk about important stuff.

RNA vaccines saved millions of lives (Image: Toby Morris)

The playing field has changed

Decoding the first human genome was completed in the year 2000 – it took a decade and cost ~US$4 billion. The same genome today costs about US$500 and takes a day. This transformational ability to sequence genomes has opened a variety of applications; from human health and disease detection through to deciding which kākāpō shouldn’t interbreed as they are cousins.

Coupled with rapid surveys of the genetic code was the discovery of CRISPR-Cas9 technologies which, unlike the gene tech of the 90s, enable precision edits to the genetic code.

One tangible example of gene technology in action is CAR-T cell therapies that are being developed here in New Zealand and overseas. If you are not up to speed on this latest acronym, CAR-T is a cancer therapy that involves removing cells from a patient, modifying them genetically, then putting them back into the patient where their new programming means they attack your cancer.  

As the regulator of the current rulebook, the Environmental Protection Authority (EPA) has already made some decisions surrounding CAR-T cells, but, arguably, the barriers, costs and timelines could be sharpened. Some low-risk applications like CAR-T might not have to be regulated under a new framework.

Whether it is a new cancer treatment, a pine tree that can’t reproduce, or a new predator control tool, these are all topics that need to be debated as the gene technology bill goes to select committee. Getting these settings “right” is vital, and this includes keeping agility in the rules given the speed of innovation.

Anti GE protesters in Auckland at the height of debate in 2003 (Photo: Michael Bradley, Getty Images)

We won’t agree on everything

Debate over the past three decades strongly indicates that the country will remain divided on this topic – some New Zealanders will remain opposed to gene editing irrespective of the application or the benefits. Some may have decided in the 90s on which side of the fence they’re sitting and don’t want to move. But I hope we can put away some of this history from last century and take a fresh look.

However, akin to the Covid-19 pandemic, I suspect the misinformation and disinformation will ramp up on this topic, as it has in the past. The call that New Zealand should remain GE free is loud. However, New Zealand is not “GE free”. There are foods we buy, vaccines we use, cotton we wear and former cancer patients who are alive today that are all the result of gene technologies. The debate has become more nuanced than “GE free”.   

If we are going to continue to put barriers in front of these technologies (especially those that are out of step with other countries), we also need to understand what we are giving up by leaving a slow, costly and precautionary approach in place. No, technically speaking our current setting is not a “ban”, but it feels like one to those involved in trying to realise some of the benefits, especially those exploring low-risk applications 

Research suggests both Māori and Pākehā have a level of comfort with medical applications, but there remains some unease around the release of gene-modified foods. Some caution in this space is justified – nobody is suggesting a free-for-all. Overseas, some countries have landed on a position that they are OK with editing of food as long as gene modifications are equivalent to the changes that could have been obtained using more traditional breeding approaches (ie where the gene technology has simply sped up the selection process).  

As the new bill is debated at select committee, a consensus (or at least clarity) will need to be developed on how both low-risk and high-risk applications are handled from technical, economic, cultural and economic perspectives.

Many countries don’t agree on how they should regulate gene technologies, but most have become more permissive in recent years as evidence mounts on safety, sustainability and benefit. 

Some caution around the release of gene-modified foods is justified (Image: Archi Banal)

A new regulator and a risk framework

While details are still patchy, the government has signalled it wishes to set up a dedicated regulatory function within the EPA that is more permissive, especially on low-risk applications.

There are two points worth noting about the government announcement. First, keeping the regulatory function within the EPA signals that the decision making will be made independent of governmental influence. In other words, the government gets to set the rules but not make the decisions. 

Second, similar to Australia, the bill will explore a regulatory risk-based framework where low-risk applications (e.g. CAR-T therapy and experiments contained within laboratories) may be permitted, but some applications that involve environmental release will still be scrutinised. I suspect it will be in the realm of “environmental release” that the debate will be had – what are the safety/benefit thresholds that need to be met to warrant release?

What next?

Before the last election, the parties now in government signalled their intention to reform gene technology laws, so it should be no surprise to see the gene technology bill on the national radar. After a period of stasis (since the 90s), things are moving quickly – the next step being draft legislation being tabled and reliance on the select committee process to play its role.

As this is going on, I hope to see Aotearoa New Zealand lift its “DNA game” a little over the binary debates from the 90s. We have some gnarly problems to tackle around sustainable food, forestry, biodiversity, climate, disease, biosecurity and human health. While not silver-bullet solutions to this shopping list of problems, genetic tools – including gene modification – will help in these missions. But first it’s imperative that we get the risk and regulatory settings calibrated so informed decisions can be made.  

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Gabi Lardies
— Staff writer
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