Gene editing and GMOs in NZ, part two – is the law out of date?

By Grant Jacobs 02/06/2014 10


(If you’re not a biologist, you may prefer to start with part one. There’s also a third part.)

Are the GMO-related clauses of the Hazardous Substances and New Organisms (HSNO) Act 1996 out of date?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My opinion is that Act is out of date in fundamental ways.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.

Other commentary

The New Zealand Science Media Centre has gathered some expert commentary on the court ruling,

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.[1]

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.[2]

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.[3]

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[4]—wasn’t announced until four years after the Act, in 2000, and the human genome wasn’t declared ‘complete’[5] 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.)

Exemptions

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.[5]

Not covered: the real GMO ‘issue’?

I have not written on what I feel are the main underlying issues of public concern on GMOs.[6] 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.

Footnotes

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 –

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:

Gene editing and GMOs in NZ, part one

GMOs and the plants we eat: neither are “natural”

Carrots for my neighbour

Haemophilia – towards a cure using genetic engineering

Scientist as activist

Supreme Court rule that natural DNA cannot be patented – sources and early feedback

Meeting–Genomics, medicine and law


10 Responses to “Gene editing and GMOs in NZ, part two – is the law out of date?”

  • You point out that we are much better able to determine what changes have been made now that we have the ability to deep sequence the newly modified organism. However, the problem with this approach is that every cross or even simply taking an organism into and out of in vitro culture will result in changes to the genome, measurable by sequencing.
    As a consequence what you would be asking then is to measure by sequencing if the directed modification resulted in relatively more random changes than you would get without using the directed modification.
    I suspect such a relative measure would be very difficult to legislate. In the end I think the better measure is a phenotypic measure where you ask if the phenotype has changed unexpectedly by undergoing a reasonable testing programme. The difficulty with that approach is who gets to decide what is reasonable.

  • I agree using phenotype* measures is quite likely to be better and it is essentially what has been done for the ‘traditional’ methods and seems to work fine – and the Act tactically recognises this when it exempts ‘traditional’ methods.

    (A point to remember is that I’m writing given we have this Act. If I were to write from a viewpoint of not having the Act at all, it’d be different. A focus on phenotypes/traits is fundamentally different to the current Act. While I”m writing, my intention is to raise discussion rather than be definitive; I’m not really expecting thoughts from a few days to be more than a seed for discussion.)

    re sequencing: simpler than that I would have thought – take the parental material and the modified material and test if the modified material has more changes than expected, an immediate before-and-after. (Point being, you’re not trying to also compare background variation, which would make things difficult as you say.)

    —-
    * For non-biologists: trait.

  • Just thinking about it a little more, readers might be tempted to think I am suggesting replacements for the Act: I’m not.

    I’m taking the Act as it currently is, noting that the court noted some issues with it, noting that these issues seem to run deeper and that the Act is set to expire some time under it’s ‘test of time’ premise and suggesting that it might be an opportune time to develop what would follow it. But I don’t suggest what that would be.

    Readers are free to offer their suggestions what that might be, of course.

  • I couldn’t agree more with your post, particularly the point about the need to reconsider the basis for regulating GMOs.

    First, a bit of background. From 1988 until 1998 when the Hazardous Substances and New Organisms Act 1996 came into force, the main safeguard against GMOs causing environmental harm was a voluntary committee (appointed by the Minister for the Environment) called Interim Advisory Committee for the Release of Genetically Modified Organisms (IAG for short). The committee was voluntary (it didn’t even get a free lunch for the first couple of years) and had no power to regulate. It did make recommendations to the minister on applications to release or experiment with GMOs. The recommendations were based on determining which overseas regulations seemed to be most sensible and then considering whether a proposal would meet those regulations.

    The minister could exert pressure on other government departments (who had made applications) to follow IAG recommendations. Applicants from the private sector had no legal obligation to abide by the recommendations, but no doubt did because if they were to be found liable for damage as the result of a GMO release, they could look to the minister (and the IAG) for wrongly recommending a release.

    In other words it was a very loose and ill-defined process that did not work in theory, but did work in practice. In an area of rapidly developing science its recommendations could attempt to keep up without being bound by out of date regulations.

    The IAG was not directly involved in drafting the new law that put it out of existence, but was extensively consulted as it was being drafted. The regulations made in 1998 were the subject of some debate and certainly were considered to be only a beginning. But they remain unchanged sixteen years on.

    (I write from personal experience. I was a member of the IAG from shortly after it was formed until it was superseded by ERMA in 1998.)

    You are quite right in your conclusion that the law here is an ass. I also agree that the scales of justice in this proceeding were not evenly balanced. Paragraph [25] points out that Scion stood down from the appeal and Dow Agrosciences (the licensee of the technology) was denied the chance to intervene. So the EPA was there in the public interest to help clarify the meaning of the law, not to take sides. The only party to contest the original EPA decision (boots and all) was the Sustainability Council. As you noted, there is no doubt where Prof Heinemann’s sympathies lie in any GMO debate. The Sustainability Council also hired two high profile lawyers, Matthew Palmer and Felix Geiringer to represent them.

    It is also helpful to understand the difference between an act and a regulation. An act is a law that has been passed by Parliament and may only be changed by another act of Parliament. A regulation is subsidiary law that is made by order in council – effectively by the cabinet of the day. Acts are meant to spell out the law in principle; regulations are meant to fill in the detail. In theory, regulations can be more easily changed to keep up with changing technologies. But this does not always happen in practice.

    In the first part of your post you said:

    “The court case that sparked this article examined an opinion that use of ZFN-1 or TALEN gene editing techniques did not create GMOs in response to an appeal to the opinion.”

    The issue was a bit subtler. The act says that a GMO is an organism in which any of the genes or other genetic material has been modified by in vitro techniques and the modifications are heritable. [Paragraph 7]. It was agreed by all that the new organisms to be created in this case were GMOs. But the act also provides an exception to the general definition; that exception being found in regulation 3 of the Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998. [Paragraph 8]

    This case was all about the meaning of regulation 3. The issue to be decided by the court is found in the last sentence of paragraph [26]:

    “Whether organisms resulting from ZFN-1 or TALEs techniques are genetically modified organisms under the Act therefore depends on whether reg 3(1)(b) expressly exempts them.”

    The three possible interpretations of the regulation are set out in paragraph [27]. The first was so broad that nobody thought it was intended. The second was that the exemption included only GMOs made by selection and propagation of somaclonal variants, embryo rescue, cell fusion, protoplast fusion or chemical or radiation mutagenesis. The third possible interpretation was that the exclusion included GMOs made all the techniques listed in the second interpretation plus techniques scientifically similar to those techniques.

    In the end the judge came to the conclusion that the second interpretation was the one that fitted most closely to the law – in spite of her serious doubts (see paragraph [72]) about the clarity of the wording of the regulation. Her reasons for doing so are set out in paragraphs [67] to [70]. The second interpretation most closely fits the overall purpose of the act – where there are doubts the more cautious approach should be adopted.

    Paragraph [68] suggests that if Scion or Dow Agrochemicals had been active parties in the appeal instead of spectators the result might have been different. The EPA did not think that there was any scientific uncertainty that the new techniques were equivalent to those listed in the regulation. The judge said:

    “I do not agree. The technologies at issue are relatively new. They are expected to perform in a certain way. But the technology is intended to cause changes more specifically and rapidly than would be the case without the intervention of this technology. There is no evidence before me which says that the environmental effects of these changes in respect of any particular application are established and therefore certain.”

    The judge had clearly not read part 1 of your post on the science! And the EPA did not present any evidence on that point because of the neutral role it had assumed.

    The reaction of the EPA chief Rob Furlong was cautious:

    “It was also difficult for the legislation covering genetically modified organisms to keep pace with rapid advances in technology. There would need to be careful consideration of how the issues should be addressed.”

    The bad news is that the decision means that the narrow 1998 list of exclusions is now cast in stone; the good news is that the regulation can be changed by order in council (i.e. a cabinet decision). It would make sense that the way to “keep pace with rapid advances in technology” is to add an additional paragraph to the regulations adding to the exclusions any technique that an applicant can satisfy the EPA does not cause any worse adverse environmental effects than the techniques already listed in reg 3. That would only be a stopgap reaction to the decision and would not meet your real criticism that the act has passed is use by date.

    The real barrier to the fundamental overhall that is needed is ideological. (Read the Green Party manifesto for details.) Good luck trying to change that.

    As for the legal process, our legal system, for better or worse, is a zero sum game – it determines who wins and who loses. Expert witnesses are bound by fairly strict rules of court that require them to give neutral evidence based solely on their expertise. But they are hired and paid for by the parties, and any party can shop around for the expert who best agrees with their point of view. Australian courts have experimented with a “hot tub” process where the experts have to sit down together at the same time and come to a consensus about factual conclusions based on their expertise. That comes closer to a search for “truth” than the process followed here, but, like anything involving lawyers, can be manipulated.

    (Just some random thoughts of a one time hobby regulator who was put out to pasture as the 1998 regulations came into force.)

  • Thanks for the long comment, Doug. (It looks more like a blog post than a comment!)

    A few loose thoughts in reply –

    Paragraph [25] points out that Scion stood down from the appeal and Dow Agrosciences (the licensee of the technology) was denied the chance to intervene. So the EPA was there in the public interest to help clarify the meaning of the law, not to take sides.

    I should have pointed this out, thanks for raising it.

    It is also helpful to understand the difference between an act and a regulation. An act is a law that has been passed by Parliament and may only be changed by another act of Parliament. A regulation is subsidiary law that is made by order in council – effectively by the cabinet of the day. Acts are meant to spell out the law in principle; regulations are meant to fill in the detail. In theory, regulations can be more easily changed to keep up with changing technologies. But this does not always happen in practice.

    Good point. One thing I was going to raise was that the list of exempted organisms seemed to want to sit somewhere it might be more readily kept up to date (my thought was something maintained by the EPA). From what you’ve written, it’s surprising the list of exemptions (or even the exemption clause as a whole?) would have been better placed outside of the Act.

    The issue was a bit subtler.

    I was aware of this, actually, it’s just I decided to try write without citing the Act and ruling blow by blow for part two as I thought readers wouldn’t like it, with the idea of keeping what you’ve referred to and other stuff from the ruling for a third part.

    I haven’t time to get back to the ruling or my notes), but my impression was that the judge noted that ZFN-1 and TALEN were presented as site-specific nucleases (and hence site-specific mutagens via endogenous DNA repair, as in my first part) – point being that they ought to be the same as other mutagens; noted that other jurisdictions ruled these as not GMOs; noted a number of issues with the Act, esp. the wording of the exemption clause; suggested a rewording; then fell back on a literalistic reading of the current wording (in a way I don’t agree with, currently).

    The ruling makes it plain the Act is thought to need attention, I just think that runs quite a bit deeper than noted and for several reasons we ought to move on past it. I agree the deeper issue can be viewed as having ideological elements; another way to look at that is as a communication issue that I touched on briefly in my final section (Not covered: the real GMO ‘issue’?).

    “I do not agree. The technologies at issue are relatively new. They are expected to perform in a certain way. But the technology is intended to cause changes more specifically and rapidly than would be the case without the intervention of this technology. There is no evidence before me which says that the environmental effects of these changes in respect of any particular application are established and therefore certain.”

    There’s words in there (some of them emphasised) that I had hoped to tackle in a third part.

    ‘Rapidly’ is a red herring here; it’s not particularly relevant, I think, and that the ruling dwelt on it looks awkward to me.

    Referring to environmental effects in closing was unexpected, too, but more later perhaps. (Trying not to make a late night, later than it already is!)

  • Doug,

    The bad news is that the decision means that the narrow 1998 list of exclusions is now cast in stone; the good news is that the regulation can be changed by order in council (i.e. a cabinet decision).

    I meant to ask if you could elaborate on this.

    How is it that the exemption list is ‘cast in stone’? What in the ruling makes that happen? (I would have thought that would essentially make the Act unworkable. The Act is supposed to be considering new techniques; if it discards them preemptively, it’s defying it’s own purpose surely?)

    How does the ruling mean that “the regulation can be changed by order in council”? Is this because the relevant clause(s) must be attended to if a judge in a ruling notes wording issues or logical issues, etc.?

    It would make sense that the way to “keep pace with rapid advances in technology” is to add an additional paragraph to the regulations adding to the exclusions any technique that an applicant can satisfy the EPA does not cause any worse adverse environmental effects than the techniques already listed in reg 3.

    I would have thought you need to add some explicitly stated means to add new techniques. The measure should be that they are genetically equivalent to techniques that are exempted.

    The reference to ‘environment’ bothers me, too; I’d have to go back to the Act and I haven’t time at the moment. Wouldn’t this want to be consistent with the environmental effects covered for chemical agents that make the bulk of the HSNO Act, but those who rally against GMOs often refer to effects outside of that.

    That would only be a stopgap reaction to the decision and would not meet your real criticism that the act has passed is use by date.

    I’d get on with what has to replace the GMO clauses myself, as in removing them and treating these methods the same as the exempted techniques.

    One more. One thing I’m bothered is that to my reading (and recollection; haven’t time to go back to the ruling – bad of me, I know) the in vitro (etc.) ruling was effectively applied before the exemption list in the closing portion of the ruling. If you have exemptions, you test them first, if one matches that’s your ruling, then you fall through to the default rule; you can’t work the other way — that would only work if the exemptions were mutually exclusive of the default rule, but (surely) the whole point of exemptions is they’re not.

    (Another late night – I’m not winning!)

  • Grant,

    My comment “cast in stone” is a reference to the doctrine of precedent – one of the first things a law student is taught. A decision of a higher legal authority is binding on a lower one. Thus the High Court decision here means that the EPA cannot in future cases make the broader interpretation of regulation 3 that it made in its initial ruling.

    The problem of how to keep the law up to date with advancing technologies is common to intellectual property laws. The Copyright Act was amended a couple of times recently to make it “technologically neutral” – the “three strikes” result is the most recent example. The Patents Act 2013 still defines an invention as a “manner of manufacture”, a definition that originated in the 1624 British Statute of Monopolies. The courts have repeatedly stated in decisions that this definition gives them scope to include technologies not even dreamed of in 1624. But as you have pointed out in the past, not everyone agrees with all the interpretations.

    It is time for the Hazardous Substances and New Organisms Act (HSNO) to be given a thorough review – asking what it was meant to achieve in 1996, whether that is still relevant nearly twenty years later, and what changes are necessary. Thirteen years on from the GM Royal Commission report, proceeding with caution may itself be causing more harm than good if, for example, New Zealand is to respond to climate change. The review should include evidence from experts (they might even try the “hot tub” approach) about the potential risks that have not eventuated and any that remain.

    Even if the act is to remain unchanged, at least regulation 3 should be updated. If the updating were to add to the list of exempted techniques, it would help. But having to amend the regs to keep adding techniques would be an exercise in continually chasing your tail. That is why I suggested something along the lines of a non-exclusive list of techniques. The proviso would be that the onus would be on an applicant to show that any new technique is equivalent to known ones.

    The minister responsible for the Hazardous Substances and New Organisms Act is the minister for the environment, currently Amy Adams. She recently announced changes to the EPA Board:

    http://www.beehive.govt.nz/release/epa-board-appointments-announced-1

    My observation is that at least the current minister, the chair of the board and its most recent appointment are not known for any anti-GMO sympathies – so if the regulations are to be changed, now is the best opportunity to do it. But in the lead up to a general election there is generally not going to be any change that might in any way be seen to be controversial.

    The real barrier to change is risk aversion. To some the risk is of GMO unknowns – and don’t try to confuse me with evidence. To others the risk is political – yes, the scientists may say it is safe, but my voters don’t believe it.

    If I knew how to get a politician to take a risky decision it could be worth a bit of money. But I have been largely ignored, as a lobbyist for intellectual property law reform for thirty years, so all I can recommend is to keep trying.

  • Hi Doug,

    My comment “cast in stone” is a reference to the doctrine of precedent

    Sure – I thought you were saying that the wording is cast in stone, hence my confusion; not interpretation of the wording, the wording itself.

    “If I knew how to get a politician to take a risky decision”

    Politicians can be timid that way? 🙂