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Australia to deregulate gene-editing techniques

A new era of genetic engineering in Australia. Photo: JAH

The government will deregulate many new controversial CRISPR gene-editing methods and products, in a move experts say will threaten organic production across the country.

The changes will allow a number of genetically engineered animals, plants and microbes to be introduced into the food chain across Australia from October 8.

GENE-EDITING ON THE WAY

Australia will no longer regulate the use of various gene-editing techniques from next month.

The decision, announced earlier this year, is the result of a review of the country’s gene technology regulations, with CRISPR gene editing approved for plants, animals, and human cell lines.

The Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 bill outlines the plans for the changes, allowing for a brief period of regulation to continue in preparation for the rollout.

The amended rules remove that requirement for the use of tools in which proteins cut DNA at a specific target site — as long as the tools allow the host cell to repair the “break naturally”.

The new technologies are approved under the condition that new genetic material is not created.

In a statement, the Office of the Gene Technology Regulator (OGTR) commented on the changes and detailed when they are set to come into effect:

“The Regulator has conducted a technical review of the Regulations to ensure the level of regulation of activities with GMOs remains commensurate with risk according to current science. The review has concluded with amendments to the Regulations being approved to provide clarity regarding regulatory capture of new technologies. 

The amendments will come into force on 8 October 2019, and until that time the current Regulations continue to apply.”

The OGTR’s verdict could eventually mean that a series of new GM animals, plants, and microbes will be introduced into the food chain with no safety assessment and, potentially, no labelling.

These products include “super-muscled pigs”, non-browning mushrooms, and wheat with powdery mildew resistance.

Previously, the use of CRISPR for research purposes was restricted because the techniques were governed by the same rules as conventional genetic modifications, which require approval from a biosafety committee accredited by the OGTR.

Now approved in Australia, a slew of labs throughout the country will work on various applications of the technology, but must wait until 8 October 2019 when the amendment comes into effect.

The regulator says that genetic edits made without templates are no different from changes that occur in nature, and therefore do not pose an additional risk to the environment and human health. 

Despite this, the new technologies continue to cause a stir all across the world.

CRISPR CONTROVERSY

CRISPR, otherwise known as “clustered regularly interspaced short palindromic repeats”, is a gene-editing technology that exploits quirks in bacteria immunity to edit genes in other organisms.

CRISPR is defined as a “gene-editing platform that makes use of a bacterially-derived protein and a synthetic guide to introduce a double strand break at a specific location within the genome”.

The widespread experimenting with CRISPR-CAs9, the currently most widely used, has only been around since about 2015.

Scientists using the “second generation” of genetic manipulation technology have used gene-editing to alter the DNA of breed of cattle to help improve ‘sustainability’ of the product in the future.

The cows had been implanted with embryos genetically edited to grow and look like males, regardless of their biological gender.

At around the same time, another group of scientists claim to have injected human cells into monkeys to create monkey-human chimeras.

According to the reports, Professor Juan Carlos Izpisúa Belmonte from the Salk Institute in the USA have produced the split species, with research being conducted in China “to avoid legal issues”.

Earlier this year, a group of Chinese researchers claimed to have deliberately gene-edited monkey clones with a mental disturbance.

Bing Su and collaborators at the Yunnan Key Laboratory of Primate Biomedical Research exposed monkey embryos to a virus carrying the human version of microcephalin. They generated 11 monkeys, five of which survived to take part in a battery of brain measurements. 

The monkeys each have between two and nine copies of the human gene in their bodies.

CRISPR gene-editing technology is being pushed as a tool to ‘enable positive change’, such as treatments for genetic diseases, altering the germline of humans and animals, modifying the genes of food crops and much more.

These technologies are at the forefront of a shift across the world towards a scientifically-driven, post-human era, where new advancements will fundamentally alter the human on a cellular level.

Australian industries have expressed concerns with how this technology will impact the country.

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BACKLASH TO THE CHANGES

A number of industry groups have spoken out against the new changes to come into effect.

In an open letter to the regulator this week, Australia’s oldest organic beef marketing company OBE Organic expressed concerns with the new technologies and where the industry will lead if allowed to be introduced:

“I am writing to express in the strongest terms possible OBE Organic’s opposition to plans to deregulate the gene editing SDN1 and CRISPR – CAS9 technology in Australia from 8 October.

I am sure you have received many representations from all agricultural sectors on this incredibly important issue so I will not repeat technical details.

I would simply like to remind you of the core consequence of this change: the complete erosion of a fundamental attribute in Australia’s ambitions to be the world’s choice for clean, safe, premium food.

Every single one of the long term strategic plans being developed by agriculture, from the NFF’s 2030 Roadmap to strategic plans for separate industries, aim to move Australian agricultural produce from a commodity to a premium product that is sought after by global consumers.”

Members and affiliates of Gene-Ethics Australia spoke on the threat these changes pose to the world stage, given Australia’s significant contribution of 51% of the world’s organic food produce: 

“Changed Gene Technology Regulations tabled in Federal Parliament threaten to undermine Australia’s status as the world leader in organic food production. The decision would leave the majority of new CRISPR and other gene editing applications unregulated. 

It would allow genetically modified (GM) ryegrass, sugar, potatoes, rice, soybeans, maize, mushrooms, fish, pigs and a host of other crops, animals and microbes to be released into the environment with no safety assessment or traceability. The changes would also make Australia the first country in the world to deregulate the use of these techniques in livestock. 

We call on the Senate and industry to protect our organic foods, farms, health, and environment by disallowing the proposed deregulation of GM plants, animals and microbes,” says Bob Phelps, Gene Ethics Director.”

As with most new biotech innovations, there is a cavalry of both critics and supporters claiming a variety of points.

One thing is certain — given the different approach being taken by regulators globally, consumers in different regions will be exposed to GM products at different intensities with international trade set to have yet another stumbling effect on health and safety standards.


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RELATED CONTENT

CRISPR editing of plants and animals gets green light in Australia. Now what? | ABC News

Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 | Legislation.gov.au

General advice from the Regulator on coverage of new technologies | OGTR

CRISPR | Wikipedia

What are genome editing and CRISPR-Cas9? |  Nlm.nih.gov

Open Letter To Parliament: Gene Editing Deregulation Undermines Brand Australia. | OBE Organic



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2 Comments on “Australia to deregulate gene-editing techniques”

  1. Heike Jindra
    September 24, 2019 at 17:03 #

    This is the result of our “Governments” actually being Corporations ……….. we, the people had been sidelined. Will we accept this ?

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