New GM technology paves the way for northern Australia’s cotton dreams

A new variety of genetically modified cotton is shaping up to be a game-changer for those looking to grow cotton in northern Australia.

Monsanto’s new Bollgard 3 is currently being trialled on a farm in the Kimberley’s Ord Irrigation Scheme in far north Western Australia.

It was planted in early February during the wet season and is showing positive signs of being resistant to insects, especially when compared to the Bollgard 2 and conventional cotton varieties that have also been planted in the trial.

CSIRO researcher Stephen Yeates said the cotton industry may have finally found a plant that could withstand the insect pressures of northern Australia’s wet season.

“The Bollgard 3 has an additional gene, which will control a key wet season pest called spodoptera,” he told ABC Rural.

“The additional gene is the only difference [to Bollgard 2]. They’re identical in every other way.

“So one of the reasons we’ve put both varieties in this trial, is to confirm there are no differences in the agronomic traits, confirm the similarities, and it’s only that [extra] insect control which is different.”

Dr Yeates said the Bollgard 3 plants at this stage were growing the same as Bollgard 2, but the increased resistance to insects was noticeable.

The Ord trial is expected to be harvested in June.

Still a lot of work ahead for northern cotton

It is not just the Ord Valley showing an interest in cotton, with farmers in the Burdekin and Gulf regions of Queensland also looking into cotton opportunities.

Dr Yeates said the introduction of Bollgard 3 gave farmers in northern Australia the opportunity to plant during the wet season, which had a number of advantages.

“The idea is to plant later in the wet season, from late January onwards, so that the early growth of the cotton is during the wet weather, and then you get the boll filling during that critical stage where you need reliable sunlight, in that April, May period if you plant early,” he said.

“So you plant in the second half of the wet, you probably don’t need to irrigate [initially], then finish the crop with irrigation and harvest in June.

“If you can get a crop off in June, you could then grow a second crop after cotton and in terms of returns, two crops would be a really big bonus.”

However, Mr Yeates said planting in the wet season also presented challenges, and accessing paddocks would be difficult in some years.

The current plan in the Ord Valley, being driven mostly by the company Kimberley Agricultural Investment (KAI), is to develop more of the region’s sandier, well-draining soils, which would improve the chances of being able to access land during the wet season to plant cotton.

KAI general manager Jim Engelke said the company was willing to invest in a cotton processing plant, but it would need about 10,000 hectares of cotton a year to make it viable.

Bollgard 3 growing commercially in the eastern states

Cotton growers in southern Queensland and New South Wales are growing Bollgard 3 commercially for the first time this year.

Andrew Sevil, from Whyenbah near St George, said despite a bad run of weather in his region, the cotton had performed well.

“From my perspective it hasn’t been too different, but I guess we won’t know until we get the cotton into the gin to see what the end result is,” he said.

“Talking to our agronomist, he’s reasonably optimistic and thinks it’s fared fairly well under difficult conditions.”

Mr Sevil said the new cotton had shown good resistance to the pest heliothis, and he was hopeful of getting 12 bales a hectare.

On its website, Monsanto describes Bollgard 3 as a “major milestone for innovation in cotton”.

“Having three proteins (genes) will increase the longevity of the technology as each protein has a different mode of action, which means each protein kills larvae in a different way,” it said.

-Written by Matt Brann in ABC News. See original article link here.

Australian OGTR approves field trial of GM Potato

The Office of the Gene Technology Regulator (OGTR) in Australia has issued a license to the Queensland University of Technology, allowing the limited and controlled release (field trial) of potato genetically modified (GM) for disease resistance.

The field trial (License Application DIR 150) is authorized to take place at one site of up to 0.1 hectare in Redland City, Queensland, for a period of two years. It will assess the agronomic characteristics and Potato virus X disease response of the GM potato plants under field conditions. The GM potatoes will not be used in human food or animal feed.

The final Risk Assessment and Risk Management Plan (RARMP) concludes that this limited and controlled release poses negligible risks to people and the environment and does not require specific risk treatment measures.

The finalized RARMP, together with a summary of the RARMP, a set of Questions and Answers on this decision and a copy of the license, are available online from the DIR 150 page in the OGTR website.

-Published in ISAAA’s Crop Biotech Update.  See original article link here.

Australian OGTR Issues License for Field Trial of GM Indian Mustard

Australia’s Office of the Gene Technology Regulator (OGTR) has issued a license to Nuseed Pty Ltd., allowing the field trials of Indian mustard (Juncea canola) genetically modified (GM) for altered oil content. The field trials (License Application DIR 149) will be carried out between April 2017 and May 2022, and will take place at a maximum of 4 sites of up to 2 hectares per site in 2017, 10 sites of up to 5 hectares per site in 2018, and 15 sites of up to 10 hectares per site in each subsequent year.

The final Risk Assessment and Risk Management Plan (RARMP) concludes that this limited and controlled release poses negligible risks to people and the environment and does not require specific risk treatment measures. The finalized RARMP, together with a summary of the RARMP, a set of Questions and Answers on this decision and a copy of the license, are available online from the DIR 149 page in the OGTR website.

-Published in ISAAA’s Crop Biotech Update.  See original article link here.

Review of Australia’s Gene Technology Regulations: Opportunity to Strengthen Australia’s Biotechnology Industry

As Australia faces the challenges that come with the end of the resources boom and a shift away from many traditional manufacturing industries, the biotechnology industry represents an important opportunity for economic growth. With an increase in the demand for biotech products comes the potential for Australia’s biotechnology sector to offer substantial growth and investment opportunities if supported by the right policy settings. It was recently reported that the sector is expected to grow at a rate of 4.4% a year until 2021, bringing AUD8,675M of revenue to industry.[1]

Further, last year alone, more than 630 biotechnology patent applications including claims referring to “nucleic acids” were filed with the Australian Patents Office – many claiming subject matter that no doubt will test the boundaries of what constitutes patentable subject matter.[2]

In an industry that has undergone rapid technological advancement since the Regulator last conducted a technical review (which resulted in amendments being made to the Gene Technology Regulations 2001 (Gene Technology Regulations) in 2011), it is timely that the Australian Gene Technology Regulator (Regulator) has initiated a technical review of the Gene Technology Regulations.

This latest review seeks to clarify whether organisms developed using newly developed technologies should be regulated as genetically modified organisms (GMOs) to ensure that new technologies are regulated in a manner commensurate with the risks they pose, and importantly, to ensure the Gene Technology Regulations reflect the current state of technology and scientific knowledge. Among the “new” technologies noted in the Regulator’s discussion paper as being relevant to the present technical review are agroinfiltation,[3] grafting,[4] RNA interference (RNAi)[5] and, of course, genome editing.[6]

Background
Under the terms of the Gene Technology Act 2000 (Gene Technology Act), “dealings” with organisms that meet the definition of “genetically modified organism” (GMO) – being an organism that has been modified by gene technology or an organism that has inherited particular traits that has occurred because of gene technology – are tightly regulated, and generally prohibited unless authorized by a GMO licence or otherwise may be characterised as “low risk”, “exempt” or specifically included in the GMO Register. While these restrictions on dealings with GMOs are aimed at minimising the risks posed by GMOs to people and the environment,[7] it is clear that the definition of “GMO” was intentionally cast broadly to ensure that it could be adapted to new technology as it develops.

The Gene Technology Regulations currently exclude a number of techniques from the definition of gene technology (including somatic cell nuclear transfer, protoplast fusion and various forms of induced mutagenesis) and a number of organisms from the definition of GMOs.[8] However, the applicability of those exclusions has become less clear with the fast development of new technologies. A major focus of the technical review will therefore be to clarify what is excluded from the definition of “gene technology” and “GMO”.

The Technical Review
The Regulator seeks submissions from interested stakeholders, offering the following four options for the regulation of new technologies:

  1. no amendment to the Gene Technology Regulations
  2. regulate certain new technologies
  3. regulate some new technologies based on the process used
  4. exclude certain new technologies from regulation on the basis of the outcome they produce.

Option 1 is self-explanatory. Option 2 proposes to amend the Gene Technology Regulations so that dealings with all organisms developed using oligo- and site-directed nuclease techniques are regulated under the Gene Technology Act. Under option 3, techniques which use a nucleic acid as a guide for directing DNA repair would result in a GMO, whereas certain techniques which do not involve the application of a nucleic acid guide would not result in a GMO. Option 2 and, to a lesser extent, option 3, would appear to have the effect of regulating organisms that are indistinguishable from those that are presently excluded from the definition of GMO, such as organisms brought about by natural, chemical or radiation mutagenesis. Option 4 proposes to exclude organisms from regulation as GMOs if the genetic changes they harbour are similar to, or indistinguishable from, those brought about by “conventional” breeding (including radiation and chemical mutagenesis).

A number of other issues will also be examined as part of the technical review including issues surrounding gene driven research and the applications of RNA interference. Stakeholders are asked to provide answers to eight consultation questions which are focused on these issues. The discussion paper also foreshadows the possibility of amending the Gene Technology Regulations to clarify the meaning of certain terms which have become increasingly ambiguous in light of technological developments such as “mutational event”, “introduction”, “foreign nucleic acid” and “non-homologous”.

The technical review must maintain the current policy settings and so cannot alter the definition of “GMO” in the Gene Technology Act. However, it is within the scope of the technical review to add to the list of techniques that are not “gene technology” and to the list of organisms that are not “GMOs”. In the event that amendments to the Gene Technology Regulations are deemed necessary, the Regulator will conduct another public consultation on any proposed amendments.

The discussion paper is available here. The initial deadline of 2 December 2016 for lodging a submission to the review has been extended to 16 December 2016.

[1] The McKell Institute BioSavvy Report, October 2016.

[2] Reference more here.

[3] Voinnet O and Baulcombe D.C. Nature 389, 553 (1997).

[4] Brosnan C.A., Mitter N., Christie M., Smith N.A., Waterhouse P.M., Carroll B.J. Proc. Natl. Acad. Sci. 104, 14741-14746 (2007)

[5] Christie M., Croft L.J., Carroll B.J. Plant J. 53, 799-805 (2010).

[6] Kim J. Nat. Prot. 11, 1573-1578 (2016).

[7] section 10.

[8] GT Regulations sch 1, 1A.

-Published in The National Law Review.  See article link here.

About the Authors:

Michael Christie Ph.D., KL Gates, biotechnology lawyer, patent application attorney
Dr. Christie is a registered Australian and New Zealand patent attorney with a technical background in biotechnology. His work includes drafting and prosecuting patent applications, providing advice on the validity and infringement of patents, and acting in opposition matters.

Dr. Christie acts across a range of technical fields including pharmaceuticals, diagnostics, agriculture, genetics and genomics, biochemistry, chemistry, food technology, nanotechology and medical devices.

Dr. Christie also assists clients to…

Michael.Christie@klgates.com
61-2-9513-2497
klgates.com

Veg Tran, KL Gates, life sciences lawyer, food technology attorney
Special Counsel
Ms Tran is an intellectual property litigator with a substantial depth of experience in advising and representing a wide range of clients in proceedings before the Federal Court and High Court of Australia, as well as in matters before the Australian Patent Office.

With a First Class Honours degree in Biotechnology and training from leading research and development organisations such as the CRC for Biopharmaceuticals, CRC for Food Industry Innovation and the Garvan Institute of Medical Research, Ms Tran practices intellectual property law with a specific interest in the biotechnology, pharmaceutical, life sciences and food technology industries. She has represented a large number of clients with global business operations and has significant experience working within multi-jurisdictional teams in patent infringement and revocation matters involving technologies such as electronic devices and components, medical devices, industrial equipment, as well as pharmaceuticals.. Many of these clients are the owners of extensive and highly valuable intellectual property portfolios world-wide, and are leading companies within their fields.

Veg.Tran@klgates.com
61-2-9513-2437
klgates.com