A few weeks ago the Environmental Protection Authority (EPA) called for submissions about proposed changes to the classifications and subsequent rules around organisms developed using chemical and radiation treatments and that may be considered products of genetic modification (GE/GMO).
For many years some plant breeding especially, has used chemical or radiation mutagenesis treatments to develop specific traits in crops such as sauvignon blanc grapes, durum wheat, some barley, tomatoes, and more recently Herbicide Tolerant (HT) swedes. Some seem safe, but some products such as HT swedes that have been implicated in the deaths of hundreds of cows, are clearly not fit for purpose.
For nearly 20 years, these chemical and radiation treatments were listed in the Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998, allowing them, including HT swedes, to be excluded from regulation as GMOs.
In 2013, an EPA committee decided some more recent technologies, termed by the EPA as treatments, (ZFN1 and TALEs) should also be excluded, resulting in a challenge to the High Court by the Sustainability Council.
The High Court found that the EPA had not acted with caution and that no evidence had been presented to show an understanding of the technologies’ environmental safety. The Court also found that the list of treatments within the legislation for exclusion from regulation as GMOs was specific, rather than listed as an example, and a clear and important separation between treatment types was made. That was between those that cause ‘point mutations,’ and those that more change chromosome numbers or cause chromosome rearrangements. Consequently, ZFN-1 and TALEs and many emerging new techniques must come under regulations as GMOs for any approvals.
This approach is seen as positive, as it would align New Zealand with key trading partners and international protocols around GE. Tens of thousands of hectares of New Zealand production is based on products of chemical mutagenesis, which is not GE by international agreement. However, the focus on trade alignment seems to be the EPA’s greater concern ahead of environmental safety, and that is where I am concerned about the products of chemical and radiation mutagenesis, such as HT swedes.
The clear distinction between GE and treatments such as chemical mutagenesis, is important for deliberation of emerging technologies and for trade assurances. However another tier of regulation needs to be developed in the HSNO Act for the ‘old’ technologies such as chemical and radiation mutagenesis, or as included in 3 (1) (b) of the Regulations ;…(including protoplast fusion or chemical or radiation treatments that cause changes in chromosome number or cause chromosome rearrangements): .
While not needing the same degree of investigation as the emerging GE technologies, there are clearly instances where these ‘old’ technologies, or treatments as the EPA prefers to call them, throw up unintended and serious outcomes. The HT swede produced by PGG-Wrightson Seeds Ltd with DuPont is the most recent obvious example, and was able to be developed, put on the market, and unexpectedly kill thousands of animals, harming many more, all without regulatory oversight, and continues to be sold with harmful consequences.
There are many products of the ‘old mutagenesis’ technologies, but a distinction was made between those technologies and GE when HSNO was designed, giving the exemption for the existing products at 29 July 1998 when the Regulations came into force, and also for subsequent developments using those technologies.
The HT swede cultivar, with its exceptionally elevated and dangerous glucosinolate levels, shows the need for oversight, but probably hundreds of cultivars including some grains and grapes are safe as intended. So how can we give some oversight to new and possibly also existing developments, a few of which may present as unsafe or not fit for purpose?
The EPA needs to develop a register that new products of chemical and radiation mutagenesis are included, once shown as fit for purpose, eg for food or forage plants, following feeding trials that show no harm.
Existing cultivars or organisms should be identified and listed in the register without any immediate analysis, but be able to be reassessed should concern be raised later, such as with PGG-Wrightson’s HT swedes, and removed from the register, and therefore use, if not fit for purpose.
A similar exercise was done with agricultural compounds where pre-existing agricultural compounds were put in a register, and have been subject to possible reassessments since. Agricultural compounds could be removed from the register if needed, with new ones following an assessment and approval process to be registered.
Using the example of the Agricultural Compounds and Veterinary Medicines Act 1997, the Director-General of Ministry for Primary Production is able to recall a compound should it no longer comply with the Act or regulations.
The purpose of that Act includes to—
prevent or manage risks associated with the use of agricultural compounds, being—
(ia) risks to public health; and
(i) risks to trade in primary produce; and
(ii) risks to animal welfare; and
(iii) risks to agricultural security:
The imported animal feed regulations (ACVM Notice: Imported Feed Commodities) have related points about risk, and clearly state the need to be fit for purpose.
Part 2: General Requirements for Feed Commodities
2.1 Fitness for purpose
(1) Imported feed commodities must not contain:
- a) physical contamination of a type or nature at a level that will result in harm to the animal for which the feed is intended, or
- b) biological contamination of a type or nature at a level that cannot be effectively managed by further processing or at the point of use on farm.
We agree with the proposed amendments to clarify the Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998, in relation to ZFN-1 and TALENs and other emerging treatments.
However provision is needed for a register with simple fit for purpose criteria for products of protoplast fusion or chemical or radiation treatments that cause changes in chromosome number or cause chromosome rearrangements. This separate register and ‘lower’ tier of oversight would ensure the ability to remove ‘non-GE’ organisms from use if needed, while also ensuring a stronger level of precaution around GE and the new technologies.