Ensuring robust GE protections must also ensure safety of older technologies

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).

Background

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.

Discussion

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.

Precedents

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:

  1. 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
  2. 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.

Recommendation

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.

5 Comments Posted

  1. Thanks Paul. German radio announces that: Round-Up will be permitted in Europe for another 10 years. Round-Up is now officially a cause of cancer, though not all European regulatory authorities have agreed on this, yet. Is the world on track to go organic? Many positive developments outside of the mainstream press-releases.

  2. Hey, I put the question, I don’t give the answer! But as they say “Google is your friend” and 2nd on the list for “gmo, ge, russia” is

    http://ecowatch.com/2015/09/18/france-russia-ban-gmos/

    France + Russia Ban GMOs
    Lorraine Chow | September 18, 2015 11:40 am |

    Russia and France have joined the growing list of European countries crusading against genetically modified (GMO) food and crops.

    According to RT, Russia is stamping out any GMOs in its entire food production.

    “As far as genetically-modified organisms are concerned, we have made decision not to use any GMO in food productions,” Russia’s Deputy PM Arkady Dvorkovich announced at an international conference on biotechnology in the city of Kirov.

    Dvorkovich added that there is a clear difference between the use of GMO-products for food versus scientific or medicinal purposes, RT reported.

    “This is not a simple issue, we must do very thorough work on division on these spheres and form a legal base on this foundation,” he said.

    Russia already has hardline policies against GMOs. In 2012, Russia banned imports of Monsanto’s corn after a French study linked the company’s GMO-product to tumors in lab rats (the study was later retracted). Last year, the country banned imports of GMO products, with Russian Prime Minister Dmitry Medvedev saying the nation already has the resources to produce its own non-GMO fare.

    “If the Americans like to eat GMO products, let them eat it then. We don’t need to do that; we have enough space and opportunities to produce organic food,” said Medvedev. (And in case you’re wondering, Russian president Vladimir Putin is also anti-GMO).

    The percentage of GMOs currently present in the Russian food industry is at a mere 0.01 percent, RT observed.

    Russia’s latest move comes after similar news pouring in from Western Europe in recent weeks.

    On Thursday, France followed in the footsteps of other European Union countries—Scotland, Germany, Latvia and Greece—and has chosen the “opt-out” clause of a EU rule passed in March that allows its 28-member bloc to abstain from growing GMO crops, even if they are already authorized to be grown within the union.

    Specifically, the country wants to shut out the cultivation of nine GMO maize strains within its borders, according to yesterday’s joint statement from Ségolène Royal, France’s Minister of Ecology and Sustainable Development, and Stéphane Le Foll, the Minister of Agriculture and Energy.

    “It is part of the very important progress made ​​by the new European framework on the implementation of GMO cultivation in which France played a leading role,” the statement reads (via translation from Sustainable Pulse). “This directive makes it possible for Member States to request the exclusion of their territorial scope of existing authorizations or of those under consideration.”

    France’s latest GMO-sweep also singles out Monsanto’s MON 810 maize, the only GMO crop grown in Europe, and is currently under review at the European level, Reuters reported.

    France, which is the EU’s largest grain grower and exporter, is further cementing its anti-GMO sentiments with this latest move. The country already prohibits the cultivation of any variety of genetically modified maize due to environmental concerns.

    Monsanto, which maintains the safety of their products, has said it will abide by the requests from the growing wave of European countries turning their backs on these controversial crops. The agribusiness giant, however, recently accused Latvia and Greece of ignoring science and refusing GMOs out of “arbitrary political grounds.”

    In a statement, Monsanto said that the move from the two countries “contradicts and undermines the scientific consensus on the safety of MON810.”

    Meanwhile, much-maligned company didn’t have a total loss this week. According to Politico EU, the Committee on the Environment, Public Health and Food Safety—a key committee in the European Parliament—”rejected a proposal Tuesday to halt an extension in the use of the world’s most popular weedkiller,” aka Roundup, Monsanto’s flagship herbicide.

    Politico EU added in its report: “Sales of the herbicide, which is contained in 750 products, must stop in December if not given re-authorization. The Commission proposes to extend marketing to June of next year.”

    Roundup contains an active ingredient called glyphosate which the World Health Organization’s cancer arm famously classified as a possible carcinogen.

    Despite the health concerns of the product, a Commission spokesman defended the decision. “Extending the approval period by six months will give EFSA [the European Food Safety Agency] time to finalize its scientific conclusions on glyphosate,” Enrico Brivio said in a statement.

    “On the renewal of the authorization, the Commission, in consultation with Member States, will take appropriate risk management action following the publication of the EFSA opinion,” he added.

  3. what is the situation exactly Paul? You could post us a link. I understand they are prohibited. But it’s not a black and white situation with what GE is, so not sure exactly what is and isn’t allowed over there. Russia are no friends of Monsanto style seed, that’s for sure. Very positive development, especially as economic power moves to the East. The East seem to be cleaning themselves up lately. They’ve kick out the banking cartel earlier this year. A move that would normally invite wwIII, but that hasn’t broken out, so the world could be on the mend. Moves, from Russia with love.

  4. Thanks for the update Steffan. I’m glade at least one of us can still follow all this gene-science and substance legislation.

    Genetic-engineering sure has advanced; with the “clean” techniques no-longer requiring anti-biotic markers and so on. On the chemical level, objection to some of these GMOs becomes difficult.

    However bio-physics has also advanced. So as we learn more about the importance of the “information fields” behind the life-forms, it becomes clear just how little these gene-butchers actually know. Though not sure kundaili considerations will find there way into our legislation anytime soon.

    Funny how gene-science becoming ever more complex. In contrast to the climate-science, becoming ever simpler. The UN dumb that down, so the whole family can enjoy it as fear-porn on the 6 o’clock news.

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