Are the GMO-related clauses of the Hazardous Substances and New Organisms (HSNO) Act 1996 out of date? Perhaps it’s time to start working on a replacement.
Recently a legal ruling in New Zealand overturned a previous opinion that using gene editing to create variants would not create genetically-modified organisms (GMOs). The key documents are gathered at the EPA website page for that query.
In part one, I offered a non-scientist’s introduction to what is intended with the type work being considered. I’ve since spent more time browsing the Act and the ruling than is healthy for someone who is not a lawyer. Here I’d like to offer some initial thoughts from this reading.
The HSNO Act (1996) also deals with hazardous chemicals. For simplicity, when I write ‘the Act’ below, I mean the portion of the Act referring to GMOs not the whole HSNO Act.
In a nutshell
The court noted difficulties in interpreting the Act. The court was very polite and modest about the difficulties it encountered: my reading suggests these difficulties run deeper and indicate the Act is not up to it’s task.
My opinion is that Act is out of date in fundamental ways. It will also expire on one of it’s founding premises at some time. Thus it would seem an opportune time to work towards what would follow the current Act. (To my reading the Act is time-limited, in that it uses a premise that once a class of techniques have stood the test of time organisms made using them are exempted from consideration; in time the techniques that create GMOs themselves will have stood this ‘test of time’ and be exempted, closing the Act. Consistent with this, a replacement for the Act would not be GMO-specific, but sit within food safety in general.)
On the ruling
Given the problems with the Act the court ruling noted, I was left wondering if a call to make no ruling could not have been made. I believe the issues run deeper than those noted in the ruling (see below).
I found the approach that the advisory experts were used was unexpected. This will reflect my not being familiar with law practices, but it left me wondering if this was the best way to resolve interpretation of an Act. In addition, I feel more comfortable with advisory experts drawn from overseas and independently of the parties involved.
On the Act
The process to add new techniques to those that are considered exempt from GMO status seems (to this non-lawyer) to be ill-defined and problematic. There appears to be no explicit provision in the Act for new techniques that will arise. (The current ruling was caught out on this.) It feels as if a constructive mechanism to add new techniques is needed.
The Act was written at a time when testing if a technique created unexpected genetic changes was challenging and seems to reflect this in it’s design. This has changed, and will continue to change. My feeling is that this leaves the Act out of date in a fundamental way.
One premise in drafting the current Act is that organisms derived from classes of techniques that have stood the test of time are considered acceptable. This means makes Act is self-limiting in time: once GMOs have been around a suitable length of time the techniques that make GMOs as a class must also be considered acceptable. Given GMOs have been around approximately 20 years now, it would seem prudent to start work towards a more appropriate longer-term solution fitting them within food safety in general rather than as a special case.
Finally, and to be fairly brutal about it, parts of the argument used in the Act look ill-formed, possibly even fallacious. This is not helped by that it’s not clear precisely what the argument is, as it’s not made explicit; the court noted similar difficulties. Perhaps symptomatically, some labels and terms are not used in a self-consistent way (to this reader), confusing different positions and at odds with what they might ordinarily mean.
In 2012 Scion asked the Environmental Protection Authority (EPA) to determine whether trees produced using ZFN-1 and TALES technologies would be considered to be genetically modified organisms (GMOs). The EPA’s opinion was that such trees would not be GMOs.
However, his week the decision was overturned by the high court following an appeal from the Sustainability Council of New Zealand.
The court’s decision ruled that ZFN-1 and TALEs techniques did in fact constitute genetic modification and any resulting organism would be a GMO, controlled under the Hazardous Substances and New Organisms Act 1996. The decision noted that the regulations relating to the Act were “not well drafted” leading to differing interpretations.
(Readers are free to point to other sources of commentary.)
Terms and meanings
Some of the terms used are misnomers in that their literal meanings and their use within the Act don’t match or seem inconsistent, sometimes in fairly complex ways.
It’s not helped by that parts of the Act are awkwardly worded or even look wrong—as noted in the ruling—nor that, to my reading, the ruling was distracted with some points I feel were not central to the issue at hand.
Better, perhaps, then to focus on what it is that people are concerned about.
The Act looks to be set up to cover concerns that new technologies might have unexpected outcomes.
As a consequence they’ve defined GMOs not in terms of the organisms made, but by the techniques used to make them.
(You could even suggest this makes the name of the Act itself is a misnomer: it’s not really about new organisms, but about new techniques for developing new organisms.)
I highlight this because when you first try read the Act and the ruling it’s puzzling until you realise it’s not in terms of organisms, but techniques.
A few terms used are not defined as a biologist might expect. (Alternatively, they have defined terms that have particular meanings in biology but not the ones meanings biologists ascribe to those terms.)
The Act has a limited lifetime; retirement plans should be made
A central premise underlying the Act is that GMOs are a new thing and might present hazards. It’s framed in terms of technologies used to make GMOs, presumably as a precautionary approach, but it’s clear that in the end it’s about the things made.
The act exempts several classes of genetic modification techniques, presumably as having stood the test time (being common and established practice at the time the Act was written).
Just as the variety of techniques that induce chemical mutations has been accepted by time, this same reasoning that underpins the Act should mean that in time the Act must acknowledge that the variety of techniques that make GMOs are also accepted as safe and at that time the Act will effectively expire under it’s own founding premise.
A key point here is that the Act has a limited lifetime. By it’s own framing it has to at some point accept the techniques that make GMOs in the same way that it accepts those that involve chemical mutagenesis or radiation induced modification.
GMOs have been around approximately 20 years now. As far as I know there are no major reports of safety issues.
How much time is needed before the Act must expire?
Given the problems with the current draft (see below), it seems an opportune time to start afresh.
One question should be if there is a genuine need now for an Act in the the current general form at all.
My current feeling is no. The science and technology used has moved on to the extent that the current basis for the Act no longer reflects current practice (see below).
The Act is dated with respect to DNA sequencing & testing
Science has moved on considerably since this Act was written in 1996, in particular it is increasingly reasonable to ask researchers to demonstrate what genetic outcomes their genetic modification techniques have.
In broad terms, the existing legislation seeks to discriminate between two types of new organisms:
- new organisms generated by techniques not involving laboratory work; these are considered not to be GMOs
- work aimed at creating new strains using laboratory techniques (in vitro techniques); these are labelled GMOs
with the decision based on how the organism is made, not (also) on what is made.
The choice to focus on how the organism is made was, I imagine, based on the idea that new techniques might generate unexpected results and that this would be a precautionary approach.
The corollary would be to demonstrate that new techniques do not generate unexpected results or that the results from new techniques are the same as methods classed as not creating GMOs. (See the next section, Exemptions.)
At the time the Act was drafted, this would have been technically challenging, but this is increasingly reasonable.
In particular, since the Act was developed in 1996 DNA sequencing technology has dramatically improved. What nearly 20 years ago could be barely tested now can.
To put this into context for non-scientists, the first draft of human genome—the first ‘big’ genome sequence—wasn’t announced until four years after the Act, in 2000, and the human genome wasn’t declared ‘complete’ until 2003. 1996 were early days in large-scale DNA sequencing. It would be understated to say that DNA sequencing technology and genetic tests have moved on considerably since.
The Act appears to have been drafted on the basis that well-established techniques were considered safe through experience, and hence exempted, and that new techniques might, potentially, have unexpected outcomes and that focusing on the techniques rather than the organisms made would therefore provide a precautionary approach.
The Act does not directly acknowledge or allow consideration of demonstrations that a new technique is equivalent to those made from established techniques that are considered safe, or demonstrations that the technique has no unexpected genetic outcomes. The absence of this may have been of no real consequence at the time the Act was drafted, but with the continuing advances in DNA sequencing and related tests (that can inspect what changes were made) this seems inappropriate.
(I would add we have good DNA sequencing and computational biology support in NZ to draw upon for these sorts of testing purposes. Disclosure: I offer computational services through my consultancy, BioinfoTools.)
The ruling made is dependent on a clause defining techniques that are exempted from being considered as creating GMOs.
The current wording of this clause is confusing, as noted in the ruling. The ruling spent considerable time grappling with how it might be read and suggested an alternative writing of it to work with.
I feel the clause is fatally flawed. It has no explicit consideration of, or provision for, techniques developed after the Act was written – an astonishing omission I would have thought.
The ruling was made in part on the basis that the techniques examined were not listed, but it seems to me that they have had no opportunity to be listed. Surely one could wait on an update to the list of exempt techniques rather than base the ruling on a dated list?
Science moves with time; the Act needs to reflect that.
Use and independence of the advisor experts
The ruling used the advisory experts in in what at least reads as an essentially adversarial fashion, with one (Dr. Paul Dijkwel) offered by the EPA and one by the Sustainability Council (Prof. Jack Heinemann). They were tasked with offering their expert opinion on interpreting several clauses of the Act. The approach had parallels with what I might have expected of, say, a criminal court case where a plaintiff and a defendant present opposing views, but not what I would have thought used if the court were trying to determine the meaning of an Act of law. Clearly this an existing practice, and so reflects my ignorance of law; nevertheless I found it striking. Would it be better that advisory experts in these sorts of cases be drawn from outside of those that have an interest in the outcome of the case or ruling? Should the court be aware of experts with particular views on the wider subject that might bias their advice? I imagine good process matters; I’d welcome comments from those with better knowledge in this area.
I feel more comfortable with advisory experts being independent of the parties with an interest in the case and ideally drawn from overseas. It’s a small country and I feel too often individuals chosen for expert roles (of all kinds, not just this ruling) are too close to the subject or have vested interests, oppositions and stances that might be difficult for a non-specialist (e.g. the courts) to perceive. Better to take people from outside local interests if possible, then?
Both advisors are university staff.
Not covered: the real GMO ‘issue’?
I have not written on what I feel are the main underlying issues of public concern on GMOs. In many ways these pre-empt much of this discussion (and would argue that there is no need for a GMO-specific Act). A key reason I haven’t tackled this is what I suspect are important in this are not especially relevant to the gene-editing techniques that were examined in the ruling, ironically because the gene-editing techniques don’t conflict with what I believe most members of the public are concerned about.
One aspect is concerns with commercial practices. It seems for a sizeable fraction of the public their main concern is with commercialisation issues and many recognise this is distinct from possible safety issues. (While I write this: the papaya example in my first part is a non-profit effort.)
Another aspect relates to concerns over when genes from other species are added. The techniques questioned in the ruling do not add new genetic material to the plants (either from other species or their own species). I suspect the underlying issue for transgenic plants or animals is that the public does not have the same notion of genes’ roles as researchers and that, then, the issue a communication problem perhaps with cultural aspects. It’s an interesting thing to explore, but this wants to be tackled elsewhere as it’s a topic in it’s own right.
(There’s more, but we could do this all day; enough for now.)
Part three adds a few further thoughts and introduces a perspective article on GMOs – this covers more on the underlying issues.
I would write a few things about the wording in the Act and the ruling itself as a third part. I feel the court ruling has been distracted by a few points and missed important elements of other points. Some have impact on the ruling, other don’t but deserve airing as they point at specific issues with the Act, but I doubt I will find time. (These posts take more time than I suspect many readers realise!) In any event I feel the broader issues I’ve raised override most of these.
1. I could go on about this at some length… There are more ways to modify an organism’s genetics than genetic engineering, and the older technologies can be viewed as genetic engineering, should you wish, just a cruder less directed form. You can think of genetic engineering as arising from changes that are ‘direct’, but mutagenesis can be direct too, really. You can talk about if the changes are randomly-placed through the genome or targeted at a particular site and argue about that, too. Likewise, some methods that are considered ‘non-GMO inducing’ in the Act can involve in vitro steps, whereas the Act identifies in vitro steps as being a critical marker of being ‘GMO-inducing’. It short, the use of terms and meanings looks muddled. To me this suggests the logic behind the Act is also muddled.
2. Ironically, this is in contrast to the techniques that are considered to not generate GMOs; for those we still rarely know what genetic outcomes they had. Philosophically, this makes the Act now look a bit silly – to me, at least.
3. The early genomes sequenced were viral, bacteria and fungi genomes. A few New Zealand scientists feature in these early genome days, including (former) Otago University Professors Diana Hill and George Petersen. (I would offer a better link for Prof. Hill, but I found none. It strikes me as a poignant reminder of how little institutions retain of some former senior players on-line after their retirement.)
4. Scare quotes because you can argue about what completed means. We’re still closing out a few tricky-to-sequence parts of our genomes.
5. Heinemann’s articles on GMOs have been widely criticised, including here at sciblogs. Readers should come to their own conclusions, of course. A short starter sampler of criticism of Heinemann’s publications and conclusions might include –
- At sciblogs: Does eating transgenic wheat destroy your liver?, replied to with Separating the chaff from the grain in the debate on GM wheat & followed up with Regulator rejects scientists’ GM concerns.
- More bad science in the service of science activism
- My take on the USA versus Western Europe comparison of GM corn
Others can be found by searching google with ‘Heinemann GMO’. Heinemann has also offered published support for Serálini’s controversial mouse research on Roundup and Roundup-ready feed. (Heinemann concluded “In the meantime, it is my view that the recent study is a valuable contribution to the scientific literature, debate and process of evaluating technologies. I trust your journal to publish quality science and you have vindicated my trust.” The journal later went on to retract Serálini’s paper. Peter Griffin covered the retraction on sciblogs.)
6. Worth considering is the report of the Royal Commission on Genetic Modification, which covered this in New Zealand. Chapter 7 (PDF file) covers crops and other field uses.
Other articles on Code for life: