EPA Says ‘null Segregants’ Aren’t GMOs – Expert Reaction

Thursday, 22 February 2024, 3:01 pm
Press Release: Science Media Centre

The Environmental Protection Authority (EPA) has just clarified that certain organisms, known as null segregants, are not considered genetically modified organisms.

Null segregants are the offspring of genetically modified organisms, but do not contain any genetic modifications themselves.

The SMC asked experts to comment.

Richard Scott, Science Team Leader, AgResearch, comments:

“This clarification provided by the Environmental Protection Authority is a welcome development in that it clears the way for potential new avenues of research for the benefit of New Zealand.

“It does not change the way we treat genetically modified organisms used in research in New Zealand, but what it does do is give us clarity on the use of organisms that we saw as being a grey area within the regulations. We had a clear view as researchers that these null segregants were not GMOs, but now we have certainty from the EPA to support this.

“The way is now cleared for researchers to consider the opportunities to use null segregants to deliver additional research and benefits to New Zealand’s industries and areas such as health, nutrition, and wellbeing.

“Opportunities may include enhanced or speed breeding of productive plant species in New Zealand that feed people or our livestock.”

Conflict of interest statement: “I was the lead organiser/ spokesperson on the application to the EPA seeking a determination on the status of Null Segregants.”

Dr Richard Newcomb, Chief Scientist, Plant & Food Research, comments:

“Null segregants can be a really useful tool in plant research and development and this determination has opened up new avenues for use of null segregants in our efforts to future proof New Zealand’s horticultural sectors. Perennial plants can take five years to reach maturity and building knowledge to determine if a new variety is commercially viable can take a decade or more. Any tools that can be used to speed up this process are highly valuable.

“Our climate is rapidly changing, and ensuring we can produce nutritious food into the future requires us to use every tool in the toolbox to produce new varieties for new environments. Using null segregants could allow us to breed new varieties for commercial testing faster.”

Conflict of interest statement: “Plant & Food Research is a co-applicant of the null segregants determination.”

Jo Putterill, Professor in Plant Molecular Genetics, University of Auckland, comments:

“Plant breeders aim to help feed the ~9 billion people expected by 2050, in the face of accelerating climate change and using more marginal land.

“But, how can crop yields, consumer attributes such as nutritional value and resistance to pests and diseases keep pace?

“Breeding plants with these desirable traits can take decades, making it a very slow process.|

“The ability to incorporate new breeding technologies into the toolkit for plant breeding can change the equation.

“For example, GMO plants with fast flowering can greatly speed up the breeding process: Blight resistance was introduced in seven years with five rounds of breeding using fast flowering apple plants.

“Once the desired plant has been bred, plants that have lost the genetic modification can be selected. These are called null segregants.

“They are derived from a GMO, but no longer carry the genetic modification that made them fast flowering. Under this ruling from the EPA, they would not be regarded as GMOs, allowing them ultimately to be grown commercially. But they still need to enter extensive field trials to test for growth, yield and desired consumer attributes. As with traditional breeding, these trials enable any plants not performing well to be excluded.

“The null segregant plants are not likely to pose any more of a risk than conventionally-bred plants.”

Conflict of interest statement:

•  
  • “Funding from Marsden and MBIE received to work on flowering-time control genes.
  • “Two flowering genes patented.
  • “The University of Auckland was a co-applicant of the determination, but I was not involved in the application process.”

Phillip Wilcox, Associate Professor in Quantitative Genetics, Department of Mathematics and Statistics, Kaikōkiri Māori, Genetics Teaching Programme, and Affiliate of the Bioethics Centre (Te Pokapū Matatika Koiora), University of Otago, comments:
Iwi affiliations: Ngāti Rakaipaaka, Ngāti Kahungunu ki te Wairoa, Rongomaiwahine, Te Aitanga-a-Mahaki

“The upcoming reclassification of null allele segregants as non-genetically modified organisms is a double-edged sword, especially for Māori. On the one hand, the promise of accelerated rates of genetic improvement has potential financial benefits for the primary sector, especially horticulture and forestry. This could, in turn, enhance Aotearoa/New Zealand’s international competitiveness across a range of primary sector enterprises.

“On the other hand, such deregulation removes the legal requirement for research organisations and breeding companies – most of which are not Māori-owned – to consult with Māori entities regarding the use of offspring of genetically modified plants and animals. Unfortunately, this risks a return to an earlier era where Māori were excluded from decisions regarding genetic modification research and applications, and were relegated to bystanders who were largely ignored. This resulted in a backlash against genetic modification by multiple Māori groups and contributed to the WAI262 Treaty claim, which is yet to be settled. This deregulation also risks ignoring the protocols and guidelines that have been developed in response to this backlash, that ensure appropriate consultation with Māori.

“Crown Research Institutes, Universities and breeding companies need to be cognisant of their social and cultural responsibilities, to avoid a repeat of the past. Such guidelines for effective engagement with Māori provide a path for this. This is particularly important in the current era where the Māori economy is expanding in part because of increased participation in primary sector activities such as horticulture, as well as environmental management.”

Conflict of interest statement: “I have ongoing collaborations with AgResearch Ltd and Plant and Food Research Ltd, and a previous collaboration with the Radiata Pine Breeding Company. My Otago University role was originally co-funded by Beef and Lamb New Zealand Limited. I also work with Māori communities in health-related genetics research, including Ngāti Porou Oranga. While the University of Otago was a co-applicant, I was not consulted.”

Professor Jack Heinemann, School of Biological Sciences, University of Canterbury, comments:

“The EPA appears to preserve regulatory consistency in this determination. For an organism not to be a GMO it must not have any genes or genetic material with a mutation, including one that results in only removal (deletion) of material, caused through the use of genetic engineering techniques. As the EPA says, a null segregant can ‘not possess a novel combination of genetic material.’

“The use of genetic engineering techniques makes it possible to massively increase the scale (that is speed, quantity, number of species) at which people can make null segregants from GMOs in a product pipeline. The accelerated breeding of fruit trees or the production of F1 null segregant hybrids from male sterile parents motivate the request to deregulate null segregants.

“I welcome EPA’s insistence that null segregants must be shown to be null segregants, not just intended to be. The credibility of its decision is dependent upon the strength of the still to be developed MPI regulations to ensure that such standards are met in null segregants.

“Presumably, there will be no releases of putative null segregants before new techniques are created, tested, and validated, and that manufacturer’s claims are routinely verified on a case by case and ongoing basis. The famous example of the undetected 4000 changes in the cattle genome created by a US company was an embarrassing reminder that how you look for unintended changes can determine what changes go undetected. I would hope that verification went beyond assurances from the manufacturer.

“Setting aside the issue of whether your whakapapa is expunged of a particular ancestry because you don’t have any DNA from a particular ancestor, the EPA decision could still complicate matters – if not undermine some market certifications, such as Organic. If consumers who rely on that trusted brand disagree with EPA’s reasoning to exempt null segregants then it might become impossible to certify products as free of them.”

Conflict of interest statement: “I don’t have any conflicts of interest that I’m aware of. I was a High Court Expert Witness in the Sustainability Council v EPA (2014?) and have challenged other EPA decisions in my role as an academic. I served on the ad hoc technical expert group for Risk Assessment and Risk Management for the Cartagena Protocol for over 10 years and remain active in that connection.”

Barry Scott, Emeritus Professor (Molecular Genetics), Massey University, comments:

“This is a decision that provides clarity to those using gene editing techniques in combination with traditional breeding methods as to whether the progeny of those manipulations will be deemed a genetically modified organism (GMO) or not.

“Such a scenario was outlined in the Royal Society Te Apārangi Gene Editing expert advice paper, Gene Editing: Scenarios in the Primary Industries (2019) where the considerations that arise from introducing a gene to speed up the breeding process, and then to cross out that genetic machinery, was discussed in considerable detail.

“However, there are those who will ask what certainty can be given that there has not been some ‘off target’ modification that will not have been detected. This is a valid question to ask, but what I think is more important is that we use the same risk analysis tools currently used in assessing any new plants or cultivars that are selected or generated by traditional breeding methods. Such an approach should ensure that the new organisms are safe for animal or human consumption.

“Unfortunately, the Hazardous Substances and New Organisms (HSNO) Act 1996 did not anticipate such major advances in genetic technologies so we are now living with an Act that is in need of serious revision, as outlined in a companion Royal Society Te Apārangi Gene Editing expert advice paper, Gene Editing: Legal and Regulatory Implications (2019). A fundamental flaw of HSNO was the generation of a regulatory framework that focuses on how the organism is generated i.e., using genetic technologies, rather than having, as we do in the regulation of medicines, a focus on the safety and efficacy of the product, regardless of how it was manufactured.

“Among the recommendations from this legal expert advice paper was that New Zealand:

• Needed a much more nuanced view, that reflects the reality that organisms cannot be simply classified as ‘genetically modified’ or ‘not-genetically modified’.
• Current legislation needs to accommodate advances in gene technologies with a risk-tiered approach where regulatory burden is commensurate with risk.

“Importantly, this new decision will bring New Zealand in line with the regulations that currently operate in other OECD jurisdictions, such as Australia and the USA. The certainty that this decision creates will be welcomed by those in the Pastoral, Horticulture and Forestry industries as well as those carrying out basic research. But as outlined above the more fundamental problem is the current state of the HSNO Act, 1996.”

Conflict of interest statement: “I have no current commercial or non-commercial activities that involve the use of genetic technologies but I did co-chair the Royal Society Te Apārangi Expert Advice group on Gene Editing from 2016 to 2018.”

Dr Glenn Thorlby, Project Lead – Tree Biotechnology, Scion, comments:

“The Environmental Protection Authority’s (EPA) clarification that null segregants are not considered genetically modified organisms (GMOs) under the HSNO Act is a positive development. The decision provides much-needed clarity for researchers and stakeholders, paving the way for the responsible development of future applications, unlocking their potential economic and sustainability benefits for New Zealand.

“As null segregant organisms lack foreign DNA, there is no scientific rationale to classify them as GMOs. This decision brings New Zealand in line with many trading partners who similarly do not regulate null segregants as GMOs.

“While Scion welcomes this decision and the opportunities it opens, including options to shorten the lengthy breeding cycle of the conifer trees that underpin the forest industry, it is essential to further align New Zealand’s regulations with those of our trading partners and competitors.

“New Zealand’s regulation of genetic technologies remains anchored in the outdated knowledge of the 1990s, failing to reflect nearly three decades of scientific progress. Other nations have moved to update their regulatory frameworks, to take advantage of this new knowledge and benefit from low-risk technologies such as gene editing. Without updated, fit for purpose regulations, New Zealand risks missing out on these benefits.”

Conflict of interest: Dr Glenn Thorlby is employed by Scion where he develops genetic tools with the potential to improve the productivity and sustainability of forestry in New Zealand. Scion was one of the applicants seeking an EPA determination on the status of null segregants.

Professor Andrew Allan, University of Auckland and Plant & Food Research, comments:

“This decision is an encouraging development for scientists who are working on plant or animal breeding.

“It will allow several new techniques to be applied to problems such as increasing global temperatures, and more extreme weather events. For example, fruit trees that have flowering more suited to hotter conditions, can be bred more quickly.

“For the public and consumer, the null segregant is not a challenge what-so-ever. Any new variety will have no new DNA (that is what defines the ‘null segregant’). It will just be improved in some aspect, due to good breeding. New Zealand can now look forward to these improvements which will benefit the industry and the consumer.”

Conflict of interest statement: “The University of Auckland and Plant & Food Research are co-applicants of the null segregants determination.”

Dr Tony Conner, CRSNZ, FNZIAHS, FRSNZ, Emeritus Scientist, AgResearch, comments:

“The EPA clarification that null segregants are not genetically modified organisms under the HSNO Act 1996 is long overdue.

“I distinctly remember debating the ‘null segregants’ issue with government officials prior to the HSNO Act in the mid-1990s. There was a lack of understanding of basic genetics and how genes segregate during sexual reproduction to result in null segregants. At the time there was no clear example of what value a null segregant might be.

“Thirty years on, there are now positive applications of null segregants. Early flowering in fruit trees substantially reduces the generation time and allows rapid breeding of new elite cultivars via conventional breeding, followed by segregating away the modified trait of early flowering. Likewise, there are opportunities to genetically modify recombination frequency along chromosomes during sexual reproduction to produce new genetic combinations, then segregate away the genetically modified trait influencing recombination.

“The opportunity presented by the decision on null segregants will no doubt stimulate new ideas and applications for the improvement of plants and animals important to Aotearoa’s primary industries.

“While the decision on null segregants is most welcome, a major challenge remains. How do you get a null segregant out of containment? What burden of proof will be required for a null segregant to be declared not genetically modified?”

Conflict of interest statement: “I am an Emeritus Scientist with AgResearch, which was the lead applicant to the EPA on this issue. However, I was not personally involved in the application process.”

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