backgrounder on zfn hard edge · 2013. 6. 19. · !2" the australian regulator’s preliminary...

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1 What is ZFN? Zinc Finger Nucleases (ZFNs) are a set of novel techniques designed to engineer new crop varieties. They are called zinc fingers because under the microscope they resemble a hand with a pointed finger. 1 ZFNs are synthesised in the lab and introduced to cells, where the “zinc finger” binds to certain DNA sequences and the nuclease cuts them. The resulting break in the DNA is then typically repaired by the plant’s or cell’s own repair mechanism and this can result in mutations that make certain genes inactive. A similar effect is achieved by use of TALEs (Transciption Activator-Like Effectors). There are three types of ZFN, each of which involves somewhat different steps. Overseas, companies such as Dow are experimenting with ZFN techniques to make new types of corn, soy and tomato. In New Zealand, the crown research institute, Scion is considering using ZFN-1 to engineer new tree varieties in the future. What was the EPA Committee asked to do? Genetically modified organisms (GMOs) are regulated under the HSNO Act. The Environmental Protection Authority (EPA) can be asked to rule on whether certain techniques qualify as GMOs, as defined under the Act. This process does not consider whether certain techniques should be regulated as GMOs for safety and transparency purposes, just whether they meet the HSNO definition of a GMO. In this case, Scion asked the EPA to determine whether ZFN-1 (one of the three ZFN approaches) and TALEs are covered by the HSNO Act. The EPA Committee decided that ZFN-1/TALEs are not GMOs under HSNO, despite two rounds of advice from EPA staff concluding that ZFN-1/TALEs are GMOs as defined by the Act. 2 The Sustainability Council is appealing that decision in the High Court. What have other jurisdictions decided? Few jurisdictions have decided whether ZFN-1 is even covered by existing regulations and whether, from a risk-perspective, its use in plant and animal breeding should be regulated. The European Union has begun to consider ZFN and other new plant breeding techniques. It has yet to determine its stance. ZINC FINGER NUCLEASE (ZFN) Backgrounder

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Page 1: Backgrounder on ZFN hard edge · 2013. 6. 19. · !2" The Australian regulator’s preliminary view is reportedly that ZFN-1s are not covered by the federal GM laws.3 Those laws are

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   What  is  ZFN?    

Zinc Finger Nucleases (ZFNs) are a set of novel techniques designed to engineer new crop varieties. They are called zinc fingers because under the microscope they resemble a hand with a pointed finger.1 ZFNs are synthesised in the lab and introduced to cells, where the “zinc finger” binds to certain DNA sequences and the nuclease cuts them. The resulting break in the DNA is then typically repaired by the plant’s or cell’s own repair mechanism and this can result in mutations that make certain genes inactive. A similar effect is achieved by use of TALEs (Transciption Activator-Like Effectors). There are three types of ZFN, each of which involves somewhat different steps. Overseas, companies such as Dow are experimenting with ZFN techniques to make new types of corn, soy and tomato. In New Zealand, the crown research institute, Scion is considering using ZFN-1 to engineer new tree varieties in the future.

What  was  the  EPA  Committee  asked  to  do?  

Genetically modified organisms (GMOs) are regulated under the HSNO Act. The Environmental Protection Authority (EPA) can be asked to rule on whether certain techniques qualify as GMOs, as defined under the Act. This process does not consider whether certain techniques should be regulated as GMOs for safety and transparency purposes, just whether they meet the HSNO definition of a GMO.

In this case, Scion asked the EPA to determine whether ZFN-1 (one of the three ZFN approaches) and TALEs are covered by the HSNO Act. The EPA Committee decided that ZFN-1/TALEs are not GMOs under HSNO, despite two rounds of advice from EPA staff concluding that ZFN-1/TALEs are GMOs as defined by the Act.2 The Sustainability Council is appealing that decision in the High Court.

What  have  other  jurisdictions  decided?  

Few jurisdictions have decided whether ZFN-1 is even covered by existing regulations and whether, from a risk-perspective, its use in plant and animal breeding should be regulated.

The European Union has begun to consider ZFN and other new plant breeding techniques. It has yet to determine its stance.

ZINC  FINGER  NUCLEASE  (ZFN)  Backgrounder    

 

Page 2: Backgrounder on ZFN hard edge · 2013. 6. 19. · !2" The Australian regulator’s preliminary view is reportedly that ZFN-1s are not covered by the federal GM laws.3 Those laws are

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The Australian regulator’s preliminary view is reportedly that ZFN-1s are not covered by the federal GM laws.3 Those laws are quite different from New Zealand’s and do not even cover types of GM that are quite clearly covered by HSNO.

Similarly, the US Department of Agriculture’s ruling that ZFN-1 does not require regulatory oversight is not a compelling example as the Federal Government barely regulates GM at all.4

Importantly, consideration to date – whether in Europe, the US or Australia - has been limited to expert panels, without wider consultation. Regulatory determinations that would draw in the public, consumer and food industry views are still to come.

Why  should  ZFN-­‐1  organisms  be  regulated?    

New Zealand is heavily reliant on agricultural exports for its economic wellbeing. High value markets are generally very sensitive to GM content: private standards implemented by many major retail chains and food processor consortia have strict zero tolerance policies or place stringent traceability requirements on suppliers. Should organisms resulting from ZFN-1/TALEs be field trialled or commercially cultivated in New Zealand and export markets subsequently deem them to be GMOs, this could have significant negative economic impacts on food exporters. Supply chain contamination can be extremely costly. This is borne out by incidents in other countries, where accidental contamination by a GMO has resulted in loss of markets and expensive programmes to eliminate the GM content from the supply chain. The sensitivity is higher still when it comes to unapproved GMOs. Recent responses to the mere possibility of trace levels of an unapproved GM wheat in US wheat exports illustrate just how sensitive markets are.

Being out in front by allowing new GM techniques to go unregulated before other countries and the marketplace have taken a position on them needlessly exposes the economy and fails to recognise the benefits being derived from the nation’s GM Free Food Producer brand.

June  2013        

1. Ghose T. 2011. When Zinc Fingers Miss the Mark. The Scientist, August 7. 2. The Committee decision is at: http://www.epa.govt.nz/search-databases/HSNO%20 Application%20Register%20Documents/APP201381_APP201381_Decision_19_ 04_ 2013.pdf 3. Maria Lusser and Emilio Rodríguez Cerezo. 2012. Comparative regulatory approaches for new plant breeding techniques. European Commission Joint Research Centre, p. 12. 4. The USDA can only regulate GMOs where plant pests (or their genes) are used. This means that many GM crops are not regulated by the Department, whereas they are or would be under New Zealand, Australian and European law.