Chronology of genetic engineering regulation in Australia: 1953-2008

17 October 2008

Rosemary Polya
Science, Technology, Environment and Resources Section


Introduction

This chronology summarises regulatory and administrative approaches employed by the  Commonwealth Government to control and monitor research and commercial applications of gene technology from its beginnings until early 2008. In 2008, it became legal for  genetically modified canola varieties approved by the Commonwealth’s Office of the Gene Technology Regulator to be grown commercially in Victoria and New South Wales.

Agricultural biotechnology which does not involve genetic engineering is not included in this chronology, but it is reviewed in The value of biotechnology applications to Australian Agriculture. A review of non-GM biotechnology – its ability and potential to improve Australian agricultural productivity. Accordingly, the regulation of cloned animals is not included here either.

The terms genetically modified (GM), genetic engineering (GE) and transgenic are often used interchangeably. Strictly speaking, however, transgenics involves the deliberate insertion of one or more genes from one species into the genome of a different species – in other words, moving genetic material across the species barrier. GE and GM are somewhat broader terms denoting any modification of genetic material, including deletions, and do not necessarily involve moving material between species.

In 1953, the publication of the structure of DNA (deoxyribonucleic acid) in Nature by Frances Crick and James Watson opened up a new scientific field, that of gene technology [1] . By 1986 the United States Environment Protection Authority had approved the release of GM tobacco plants, the first release of a genetically engineered crop. The utility of this technology was apparent with the commercialisation of GM crops in the United States in 1995. By 2007, the International Service for the Acquisition of Agri-Biotech Applications (ISAAA) reported that 114.3 million hectares (282.4 million acres) of GM crops were under cultivation globally. Australia’s contribution to this was approximately 0.1 million hectares of GM cotton, a decrease from the 0.2 million hectares reported in 2006 [2] .

Apart from agricultural crops, GE is used to produce medical products including insulin, human growth hormones, blood-clotting agents and vaccines such as hepatitis B. One controversial therapy involves a genetically engineered protein, the monoclonal antibody TGN1412. This was administered in a British trial in 2006. The drug was designed to treat immunological diseases but produced life-threatening adverse effects in trial patients.

Like some other new fields of scientific endeavour, for example telecommunications or transport, applications of genetic engineering went unregulated or under-regulated for some time. In particular, there has been considerable lobbying for the mandatory labelling of foods containing GM ingredients and the management of environmental and health implications of GM crops.

One of Australia’s first Commonwealth administrative mechanisms for GE was the Genetic Manipulation Advisory Committee (GMAC) but the Committee’s guidelines had no legal force. However, compliance could be achieved when it was stipulated in research grant conditions that compliance with GMAC guidelines was mandatory.

Australia’s current regulatory platform is underpinned by the Gene Technology Act 2000 (Cth) and the Gene Technology Agreement between the Commonwealth, states and territories. However, there are those who may argue that significant regulatory gaps remain. For example, it could be argued that more could be done to encourage best practice for human and environmental safety, as well as to compensate economic disadvantage that could arise from gene technology applications.

Because Australian measures are influenced by scientific developments in other nations and their attempts to regulate gene technology, some overseas scientific and regulatory milestones and reviews are also included in this chronology.

While not attempting to include a complete bibliography, this chronology does provide references to a selection of reports, journal and newspaper articles that describe the history of gene technology in Australia, the events that provided an impetus to the development of regulation and the dilemmas that are still faced.

Note that web links were active as of April 2008 but some links are only accessible through the Parliament House intranet.

List of acronyms

ABARE

Australian Bureau of Agricultural and Resource Economics

ANZFA

Australia New Zealand Food Authority

ANZFSC

Australia New Zealand Food Standards Council

AOF

Australian Oilseeds Federation

ASCORD

The Academy of Science Committee on Recombinant DNA Molecules

AQIS

The Australian Quarantine Inspection Service

AVCC

The Australian Vice-Chancellors’ Committee

DNA

Deoxyribonucleic acid or  deoxyribose nucleic acid

CSIRO

Commonwealth Scientific and Industrial Research Organisation

EU

European Union

FAO

The United Nation’s Food and Agriculture Organisation

FSANZ

Food Standards Australia New Zealand

GE

Genetically engineered, genetic engineering

GM

Genetically modified

GMAC

Genetic Manipulation Advisory Committee

GMO

Genetically modified organism

GRAS

Generally Recognised As Safe

IBCs

Institutional Biosafety Committees

LMO

Living modified organism

MAS

Marker-assisted selection

NCF

Network of Concerned Farmers

NFA

Australia’s National Food Authority

NFSC

National Food Standards Council

NHMRC

National Health and Medical Research Council

OECD

Organisation for Economic Co-operation and Development

OGTR

Office of the Gene Technology Regulator

RDMC

Recombinant DNA Monitoring Committee

RNA

Ribonucleic acid, Ribose nucleic acid

RNAi

RNA interference technology

USFDA

United States Food and Drug Administration

WHO

Word Health Organisation

WTO

World Trade Organisation

Glossary

Artificially selected

Conventional plant breeding techniques such as cross fertilisation, progeny selection and backcrossing.

Biotechnology

Using biological systems for industrial purposes.

DNA

Deoxyribose nucleic acid. Genetic material found in the nuclei of all cells and in many viruses.

Genes

Heritable material comprised of nucleic acids. With the exception of some viruses, all genes are composed of DNA. Heritable characteristics influence cellular and organism level functions

Genetically modified

Describes an organism whose genetic make-up or genotype has been altered to achieve a changed function; for example, the production of a chemical.

Genetic engineering

The process of changing genetic function by directly altering genetic material or its expression

Marker-assisted selection

A process used in biotechnology to pick out a gene trait of particular interest, in cases where that trait is not easily detectable. A marker linked to the gene of interest is detected instead. This marker could be another gene or a sequence of DNA. It is always present with the gene of interest but does not influence it. The features of the marker allows scientists to select and follow the gene of interest.

Monoclonal antibodies

An antibody is a protein molecule that reacts with, and sticks to, a specific molecule called an antigen. There are many types of antibody, each reacting with their own antigens. Monoclonal antibodies are genetically engineered antibodies all of the same type.

Oncogenes

Genes that regulate cell division and, if mutated, may cause cancer.

Recombinant DNA

DNA that has been reformed artificially in a new combination

Ribose nucleic acid

Genetic material found in the cytoplasm of cells that conveys heritable characteristics and controls cellular and organism level functions. In some viruses it is also used to make genes.

Substantially equivalent

When a genetically modified food is deemed to have the same safety status as its conventional food counterpart.

Transgenic

Where living organisms have been altered through human intervention with the insertion of foreign gene/s.

 

Chronology


Milestones

Details

Source Documents

1953

James Watson and Francis Crick establish the structure of deoxyribose nucleic acid (DNA). The structure is developed from x-ray measurements of DNA by Maurice Wilkins and Rosalind Franklin.

J. D. Watson and F.H. Crick, ‘A structure for deoxyribose nucleic acids’, Nature, vol. 171, no. 4356, 1953, pp. 737–738.

1971

Kjell Kleppe and co-workers first describe a method, the polymerase chain reaction (PCR), to copy short DNA fragments and thus facilitate genetic engineering research.

K. Kleppe et al., ‘Repair applications of short polymerases’, Journal of Molecular Biology, vol. 56, no. 2, 1971, pp. 341–361.

December 1972

One of a number of papers on the first total synthesis of a gene is published.

H. Khorana et al., ‘Total synthesis of the structural gene for alanine transfer ribonucleic acid from yeast’, Journal of molecular biology, vol. 72, December 1972, pp. 209–217.

1973

Scientists produce the first genetically modified organism, Escherichia coli (E. coli), which is implanted with a frog gene.

R. Cohen et al., ‘Construction of Biologically Functional Bacterial Plasmids In Vitro’, Proceedings of the National Academy of  Sciences of the USA, vol. 70, no. 11, 1973, pp. 3240–3244.

1974

The US National Institutes of Health is asked in the ‘Berg letter’ to develop guidelines for recombinant DNA research. The letter arose from concerns expressed at the Gordon Conference on ‘Nucleic acids’. The letter calls for a voluntary moratorium for some recombinant DNA research. (Recombinant DNA is DNA that has been reformed artificially in a new configuration).

Australian Academy of Science, Recombinant DNA: An Australian perspective, Australian Academy of Science, Canberra, 1980, p. 41.

P. Berg et al., ‘Potential hazards of recombinant DNA molecules’, Science, vol. 185, no. 4148,  no. 4732, December 20, 1974, p. 303.

1974

The Australian Academy of Science circulates information about this in December 1974. A committee chaired by Professor G. L. Ada and including Professor J. Pittard and Dr. J. Peacock examines risks.

Australian Academy of Science, op. cit., p. 67.

1975

Genetic engineering guidelines are developed by the Australian Academy of Science to provide guidance for those involved in a new area of scientific endeavour. The Academy of Science’s Committee on Recombinant DNA Molecules (ASCORD) is established in response to Professor Ada’s report. In addition to guidelines for physical and biological containment, ASCORD establishes safety training, the establishment of biosafety committees in research facilities, the review of research proposals and advice about safety issues, as well as liaison with other national committees.

Australian Academy of Science, op. cit., pp. 68–69.

1976

The International Council of Scientific Unions (ICSU) establishes the Scientific Committee on Genetic Experimentation (COGENE) and Australia ’s Academy of Science is a participant.

Australian Academy of Science, op. cit., p. iii.

G. L. Ada, Guidelines for both physical and biological containment.

1976

The Australian guidelines, a combination of those of the US and UK, are published. They are subsequently revised in 1978, 1979 and 1980.

Procedures for work involving recombinant nuclei acid molecules’, Search, vol. 7, 1976, p. 12.

February 1977

Fred Sanger and his team achieve the first sequencing of the complete genome of an organism, a bacteriophage phi-X 174.

F. Sanger et als., ‘Nucleotide sequence of bacteriophage phi X174 DNA’, Nature, vol. 265, no. 5596, February 24 1977, pp. 687–95.

1977

A human gene is expressed in bacteria for the first time. The pancreatic hormone somatostatin is produced by the US company, Genentech.

Ann Thayer, ‘Insulin’, Chemical & Engineering News, vol. 85, no. 25, 2005, p. 74.

1978

Australian John Shine is part of a team that is the first to clone human genes—an insulin gene and a human growth hormone gene.

‘Synthesis of growth hormone by bacteria’, Nature, vol. 276, 1978, pp. 795–798.

M. Rimmer, ‘Genentech and the stolen gene: patent law and pioneer inventions’, Bio-Science Law Review, vol. 5, no. 6, 2002–2003, pp. 198–211.

1978

Genentech synthesizes human insulin from a strain of E. coli.

Genentech, The insulin synthesis is the first laboratory production DNA technology, media release, 6 September  1978.

May 1979

The Commonwealth Scientific and Industrial Research Organisation’s (CSIRO’s) Review Committee submits their report, Recombinant DNA Techniques in Research to CSIRO. One of its recommendations is a further review on industrial microbiology.

CSIRO, Biotechnology research and development: The application of recombinant DNA techniques in research and opportunities for biotechnology in Australia, CSIRO, Canberra, 1981, pp. v–vi.

1980

The Australian Academy of Sciences examines the need to monitor recombinant DNA research in Recombinant DNA: An Australian perspective, finding that voluntary monitoring should continue and containment guidelines should be established.

Recombinant DNA Monitoring Committee, Monitoring recombinant DNA technology: A five year review, Department of Industry Science and Technology, Canberra, 1986, p. 12.

1980

Release of modified organisms into the environment is prohibited in the ASCORD guidelines.

Australian Academy of Science, op. cit., p. 77.

1980

The Commonwealth Government assumes responsibility for the monitoring of genetic engineering research at the recommendation of the Australian Academy of Sciences. The rationale is that industry would soon use recombinant DNA technology.

Recombinant DNA Monitoring Committee, Report, Period October 1981 to October 1982, Department of Science and Technology, Canberra, 1983, p. 2.

1980

The CSIRO executive requests a review encompassing biological systems applications of recombinant DNA technology.

CSIRO, op. cit., p. vi.

1980

Transgenic mouse embryos are created with the addition of foreign DNA, opening up the prospect of genetically engineered animals.

J. W. Gordon et al., ‘Genetic transformation of mouse embryos by microinjection of purified DNA’, Proceedings of the National Academy of Sciences of the USA, vol. 77, no. 12, pp. 7380–7384.

October 1981

The Recombinant DNA Monitoring Committee (RDMC) is set up by the Commonwealth Government in the Department of Science and Technology. It oversees a voluntary regime. Institutional Biosafety Committees (IBCs) are also set up at universities and research institutes to ensure that day-to-day research work is compliant. The RDMC must report within five years on whether monitoring should continue.

Recombinant DNA Monitoring Committee, Report for the period 1 July 1986 to 30 November 1987, Department of Industry, Technology and Commerce, Canberra, 1988, p. 2.

November 1981

The CSIRO Review Committee publishes its report on the potential and arising requirements of recombinant DNA research. It recommends that voluntary compliance with guidelines should continue but the Department of Science and Technology should devise further oversight mechanisms for a trial production of recombinant DNA strains. It also recommends that the Commonwealth Government assume responsibility for a National Microbiological Culture Collection and for support of the World Data Centre. Recommendations also address CSIRO’s involvement in the commercialisation of their innovations. Areas of anticipated commercialisation include vaccines, growth factors, diagnostic reagents, improved ethanol production, modified gluten for food, waste management and mineral processing.

CSIRO, op. cit., pp. 43, 83, 84.

1981

In the US the entire DNA genome of the polio virus is synthesised in vitro.

V. Racaniello et al., ‘Molecular cloning of poliovirus cDNA and determination of the complete nucleotide sequence of the viral genome’, Proceedings of the National Academy of Sciences, vol. 78, 1981, pp. 4887–4891.

May 1982

Guidelines for Small Scale Work with Recombinant DNA is published by the Recombinant DNA Monitoring Committee.

 

1982

In the US, the Food & Drug Administration approves the first genetically engineered drug, recombinant human insulin. The Canadian manufacturer names the product “Humulin”.

Ann Thayer, op. cit., p. 74.

April 1983

Draft Guidelines for Large Scale Work with Recombinant DNA is issued by the Recombinant DNA Monitoring Committee.

 

December 1983

The Ad Hoc Group on Safety and Regulations is convened by the Organisation for Economic Co-operation and Development (OECD).

Organisation for Economic Co-operation and Development, Recombinant DNA safety considerations, OECD, Paris, 1986, p. 3.

1983

Annual reporting commences in Australia. The RDMC reports to the Minister. Annual reports include information about research proposals, field trials, biosecurity breaches, administrative and regulatory activities, publications.

 

1984

The Commonwealth Government’s National Biotechnology Program—Research Grants Scheme provides its first grants.

Recombinant DNA Monitoring Committee, Report for the period 1 July 1983 to 30 June 1984, AGPS, Canberra, 1985, p. 2.

 

The Patents Amendment Act 1984(Cth) passes. It requires that where a micro-organism strain is not to be publicly patented, a sample must be deposited as directed. The National Animal Serum Bank at the Australian Agricultural Health and Quarantine Service will house Australia ’s International Deposit Authority.

A consultant’s report, Interaction of the Monitoring System with Regulatory Systems in Australia is released by the Department of Science and Technology.

Recombinant DNA Monitoring Committee, Report for the period 1 July 1984 to 30 June 1985, AGPS, Canberra, 1985, p. 2.

 

Michael Barker’s study on Australian law and recombinant DNA research is released.

M. Barker, The recombinant DNA technique and the law: a review of Australian law which may be relevant to the regulation of recombinant DNA research and applications, Department of Science and Technology, Canberra, 1984.

April 1985

Guidelines for Small Scale Work with Recombinant DNA is published.

 

1985

The Recombinant DNA Monitoring Committee releases its interim arrangements for live genetically modified organisms that are released into the environment, along with Guidelines for Large Scale Work with Recombinant DNA.

Genetic Manipulation Advisory Committee, Report for the period 22 August 1988 to 30 June 1989, Department of Administrative Services, Canberra, 1990, p. 10.

1985

By 1985 more than 400 research projects have been registered with the RDMC.

Recombinant DNA Monitoring Committee, Report for the period 1 July 1984 to 30 June 1985, op. cit., p. 1.

1985

Kary Mullis and colleagues at CETUS Corporation in the USA develop the polymerase chain reaction (PCR), a technique for replicating (amplifying) DNA sequences of interest thus making it easier to replicate large amounts of genes for experimentation. The work later wins Mullis the Nobel Prize for Chemistry.

R.K. Saiki et al., ‘Enzymatic amplification of beta-globin genomic sequences and restriction site analysis for diagnosis of sickle cell anaemia’, Science, vol, 230, 1985, p. 1350.

7 October 1986

The Hon. Dr N. Blewett, the Minister for Health, announces the endorsement of the National Health and Medical Research Council’s (NHMRC) Australia-wide Food Standards Code.

R. Polya, ‘Food regulation in Australia – a chronology’, Chronology, no. 1, Parliamentary Library, Canberra, 2001–02, p. 16.

1986

The first five-year review of the RDMC reaches the conclusion that voluntary guidelines have worked well and so special Commonwealth gene technology legislation is not necessary. Also, most ‘applications and activities’ such as ‘therapeutic substances, quarantine, stock medicines, occupational health and environmental quality’ are governed by state and Commonwealth laws.

Recombinant DNA Monitoring Committee, Monitoring recombinant DNA technology: A five year review, op. cit., p. 11.

May 1987

Planned Release Assessment Procedures are released by the RDMC. Specific planned releases include a live Salmonella vaccine to be used in the live sheep trade, a Rhizobium strain involved in the formation of nitrogen in legume roots, a vaccine against bovine rhinotracheitis, a live Salmonella typhimurium vaccine for sheep and a ‘Nogall’ Agrobacterium radiobacter.

Genetic Manipulation Advisory Committee, Report for the period 22 August 1988 to 30 June 1989, Department of Administrative Services, Canberra, 1990, pp. 15–16.

Recombinant DNA Monitoring Committee,  Procedures for assessment of the planned release of recombinant DNA organisms, Department of Science and Technology, Canberra, 1987.

September 1987

The Genetic Manipulation Advisory Committee, a non-statutory body with wider terms of reference than the RDMC, is announced by the Minister for Industry, Technology and Commerce. There will also be a Group of Officials on Biotechnology Regulations (GOBR).

Genetic Manipulation Advisory Committee, Report for the period 22 August 1988 to 30 June 1989, op. cit., p. 1.

1987

GMAC will oversee the development or introduction of novel genotypes produced via genetic manipulation that are unlikely to occur in nature or may pose a public health or environmental risk. That means that all ‘innovative genetic manipulation technology’, rather than only recombinant DNA technology, will be overseen.

Genetic Manipulation Advisory Committee, Report for the period 22 August 1988 to 30 June 1989, op. cit., pp. 1–2.

 

Although compliance of GMAC guidelines is not mandatory, actions such as cancellation of tax concessions or research funding or even common law can be used to encourage compliance. The states have regulatory powers for GMOs.

Genetic Manipulation Advisory Committee, Annual Report 1991 - 92, Department of Administrative Services, Canberra, 1992, p.4.

1987

CSIRO Plant Industry scientists, Drs Jim Haseloff and Wayne Gerlach, develop ‘gene shears’ from naturally occurring ‘hammerhead’ ribozymes which can cut messenger RNA in living cells, thus preventing genetic information from being relayed. This holds particular promise in the fields of health therapies and agriculture. CSIRO patents the technology. Clinical trials of ‘gene shears’ in a human immunodeficiency virus commence at St Vincent’s Hospital, Sydney.

CSIRO, Gene shears in cutting edge anti-aids trial, media release, CSIRO, Canberra, 4 August 1997.

1987

The Plant Variety Rights Act 1987 (Cth) is passed to give plant breeding innovators legal protection.

 

April 1988

Provisional patent documents are lodged with Australia ’s Patents Office for Australia ’s first patent for a GM animal, a pig. A further patent for a GM sheep is expected to be lodged in 1988.

‘Three little piggies go transgenic’, Sydney Morning Herald, 15 April 1988.

July 1988

Ministerial responsibility for GMAC transfers to the Minister of Administrative Services from the Minister for Industry, Technology and Commerce.

Genetic Manipulation Advisory Committee, Annual Report 1991–92, op. cit., p. 4.

22 August 1988

The Genetic Manipulation Advisory Committee is created. The Committee has 19 members appointed for three-year terms.

Genetic Manipulation Advisory Committee, Annual Report 1991–92, op. cit., p. 56.

1988

Four subcommittees of GMAC are created, namely, the Scientific Sub-committees, the Large Scale Sub-committee, the Planned Release Sub-committee and the Public Liaison Sub-committee.

Genetic Manipulation Advisory Committee, Report for the period 22 August 1988 to 30 June 1989, op. cit., p. 4.

1988

Gene Shears Pty Ltd is formed between partners CSIRO and Groupe Limagrain, a French seed firm, to commercialise the ribozyme technology that Haseloff and Gerlach have developed.

CSIRO, Gene shears in cutting edge anti-aids trial, media release, CSIRO, Canberra, 4 August 1997.

1989

GM therapeutic goods are regulated under the Therapeutic Goods Act 1989(Cth).

 

1989

Revised guidelines for small-scale genetic manipulation work are published.

Genetic Manipulation Advisory Committee, Guidelines for small scale genetic manipulation work, GMAC, Canberra, 1989.

12 June 1990

The Minister for Industry, Technology and Commerce proposes that the House of Representatives Standing Committee conduct an inquiry into the regulation of GMOs and associated issues.

Genetic Manipulation Advisory Committee, Annual Report 1991 - 92, op. cit., p. 4.

9 October 1990

GMAC reports that Metrotec researchers have sold 67 genetically engineered pigs to an abattoir for human consumption. The slaughter had been approved by the NHMRC and the South Australian Department of Health. The company had not informed their university’s biohazard committee about this as required by GMAC guidelines.

D. Smith, ’Scientists may lose funds over superpigs’, Sydney Morning Herald, 9 October 1990.

December 1990

GMAC publishes new guidelines for large scale work, which includes new Good Industrial Large Scale Practice (GILSP) procedures adopted by OECD countries.

Large-scale work takes place in contained facilities with quantities greater than 10 litres. The guidelines are designed to minimise risks from possible hazards. Provisions include: certification and inspection of facilities, record keeping and reporting, standards for the containment of experimental materials and their transport and medical surveillance of staff.

Genetic Manipulation Advisory Committee, Guidelines for large scale work with genetically manipulated organisms, GMAC, Canberra, 1990.

Genetic Manipulation Advisory Committee, Annual Report 1990–91, op. cit., p. 7.

1990

The National Health and Medical Research Council’s Food Science and Technology Sub-committee (FST) develops guidelines regarding the use of genetically engineered plants and animals as foods. It is agreed that where there is doubt the FST will seek clarification from GMAC.

The Australian Quarantine Inspection Service (AQIS) suggests amendments to the Quarantine Act 1908(Cth) to enable identification and assessment of imported GMOs.

Genetic Manipulation Advisory Committee, Report for the period 1 July 1989 to 30 June 1990, op. cit., 1990, p. 11.

ibid., 11.

1990

GMAC’s secretariat contributes to the OECD Group of National Experts on Safety on Biotechnology.

Genetic Manipulation Advisory Committee, Report for the period 1 July 1989 to 30 June 1990, op. cit., 1990, p. 12.

1990

The House of Representatives Standing Committee on Industry Science and Technology begins an inquiry into GMOs.

 

1990

An international program to map the human genome begins. It is coordinated by the US Department of Energy and the National Institutes of Health.

US Department of Energy Office for Science, ‘Human Genome Project Information’, US DOE, 2008.

March 1990

The US FDA regulates for its first GM food related substance, chymosin (rennet), a milk clotting enzyme used to make cheese. They assessed this enzyme, derived from E. coli K-12, as GRAS (generally recognised as safe). The final food does not contain any antibiotic-resistance marker genes or production micro-organisms.

J. H. Maryanski, ‘FDA's policy for foods developed by biotechnology,

American Chemical Society Symposium Series No. 605, US Food and Drug Administration, 1995.

1990–1

Commonwealth, state and territory Ministers from portfolios dealing with biotechnology matters discuss regulatory directions.

The Commonwealth’s Veterinary Chemicals Advisory Committee confirms that veterinary chemicals that are genetically modified products come under the Agricultural and Veterinary Chemicals Act 1988 and clearance must be obtained from the Australian Agricultural and Veterinary Chemicals Council, before marketing. Imported GMOs must be assessed by GMAC or the Institutional Biosafety Committee.

Genetic Manipulation Advisory Committee, Annual Report 1990–91, op. cit. p. 13.

February 1991

The GMAC newsletter, GMAC news, commences.

 

27 June 1991

The National Food Authority Act 1991(Cth) is assented to, establishing the National Food Authority (NFA). The NFA is responsible to the Minister for Human Services and Health and is to prepare and recommend standards to the National Food Standards Council (NFSC).

R. Polya, ‘Food regulation in Australia – a chronology’, op. cit., p. 16.

1991

Gene Shears Pty Ltd takes on another partner, the Australian subsidiary of Johnson & Johnson.

CSIRO, Gene shears in cutting edge anti-aids trial, media release, CSIRO, Canberra, 4 August 1997.

1991

The Australian Agricultural and Veterinary Chemicals Council rejects an application for the registration of recombinant bovine somatotropin (rBST). This synthetic form of the hormone BST is used in 24 countries, including the US, to encourage higher milk production in cows. There are animal health concerns because injected cows may get mastitis. Antibiotic treatment may result in higher levels of antibiotic residues in the final foods—milk, cheeses etc.

Food Standards Australia New Zealand, Draft Assessment Report: Proposal P296 - Primary production and processing standard for dairy, FSANZ, 2006, Canberra, p. 93.

26 March 1992

The House of Representatives inquiry on the regulation of GMOs produces 48 recommendations including: the establishment of legislation to govern genetic engineering activities, the need for public communications within the constraints of the commercial-in-confidence needs of applicants, the retention of GMAC for contained work and a new authority to administer releases of GMOs within the Science and Technology portfolio.

House of Representatives. Standing Committee on Industry, Science and Technology, Genetic manipulation: The threat or the glory? House of Representatives. Standing Committee on Industry, Science and Technology, Canberra, 1992.

October 1992

The government response to the report, Genetic manipulation, is released.

Australian Government response to Genetic manipulation: The threat or the glory ? A report by the House of Representatives Standing Committee on Industry, Science and Technology, Parliament of Australia, Canberra, 1992.

October 1992

The intention to replace GMAC with a statutory body is indicated in the Government’s response to the House of Representatives report Genetic manipulation–the threat or the glory. The October GMAC meetings 28 consider the terms of reference and structure of GMAC prior to its replacement. Senator McMullen asks the Department of Science and Technology to report to him on the matter.

Genetic Manipulation Advisory Committee, Annual Report 1993–94, Department of Administrative Services, Canberra, 1994, pp. 12–13.

December 1992

A review of genetic manipulation risk levels is released. It is reprinted as Appendix A of the 1992-3 GMAC Annual report.

Genetic Manipulation Advisory Committee, A review of the risk levels associated with innovative genetic manipulation techniques, Department of Administrative Services, Canberra, 1992.

1992

GMAC responds to the Genetic manipulation report.

Genetic Manipulation Advisory Committee, ‘GMAC response to the Report’s recommendations’, Annual report 1991–92, op. cit.

1992

The Department of the Arts, Sport, the Environment and Territories chairs a Working Group of the Joint Ministerial Council on a National Approach to the Assessment and Control of Genetically Modified Organisms.

Genetic Manipulation Advisory Committee, Annual report, 1991–92, op. cit., p. 19.

1992

The establishment of a Gene Technology Approval Authority is considered by a Commonwealth Interdepartmental Committee chaired by the Department of Industry, Technology and Regional Development. The Commonwealth’s National Food Authority (NFA) examines the issue of foods developed with the use of gene technology. The NFA works on labelling guidelines for food containing GM ingredients and a proposal to require pre-market assessment of such foods.

National Food Authority, Annual report 1992–93, NFA, Canberra, 1993, p. 23.

National Food Authority, Draft risk analysis report: Application A385 - Food derived from insect-protected Bt-176 corn, ANZFA, Canberra, 2000, p. 78.

1992

During 1991–2 the NFA examines three applications for processing aids produced by GMOs. The NFA also holds discussions with those involved in the production of GM tomatoes, potatoes and pigs but receives no proposals for  approval for their use as food.

National Food Authority, Annual report 1991–92, AGPS, Canberra, 1992, p. 17.

1992

China produces the first commercialised GM crop, a virus-resistant tobacco.

C. Pray and J. Huang, ‘Biofortification for China: political responses to food fortification and GM technology -  interest groups, and possible strategies’, AgBioForum, vol. 10, no. 3, 2007, p.2.

June 1993

The NFA prepares proposal P97 to regulate GM foods. The proposal must, in particular, comply with sections 9 and 10 of the National Food Authority Act 1991(Cth) (now known as the Australia New Zealand Food Authority Act 1991(Cth)) which provides for the protection of public health and safety, sufficient consumer information about foods and fair trading.

Australia New Zealand Food Authority, Assessment guidelines for foods and food ingredients to be included in Standard A18 – Food derived from gene technology, ANZFA, Canberra, 1997, pp. 1–3.

July 1993

The NFA releases a discussion paper on GM foods.

National Food Authority, Assessing the safety and consumer information requirements of genetically manipulated organisms in food, NFA, Canberra, 1993.

7 October 1993

GMAC agrees with the NHMRC that a national committee should be established to assess research proposals for human gene therapy.

Genetic Manipulation Advisory Committee, Annual Report 1993–94, op. cit., p. 14.

November 1993

The US Food and Drug Administration approves Monsanto’s Posilac, a synthetic growth hormone, a recombinant bovine somatotropin (rbST) which is used to increase milk production in cows by about 15 per cent. It is one of the first GM products to influence the food supply.

US Food and Drug Administration Centre for Veterinary Medicine, BST update, media release 21 March 1996.

S. Phillips, ‘Genetically engineered foods’, CQ Researcher, vol. 4, no. 29, 5 August 1994, p. 1.

December 1993

The Minister for Administrative Services does not accept his Department’s report on the interim arrangements for GMAC. GMAC’s terms of reference are changed.

Genetic Manipulation Advisory Committee, Annual Report 1993–94, Canberra, op. cit., p. 13.

1993

The revised edition of GMAC’s Guidelines for Small Scale Genetic Manipulation Work is published. The new edition cautions researchers about hazards when working with oncogenes (genes that turn on cell division), tumour-suppressor genes and PCR (polymerase chain reaction technique). A new Proposal Form for Assessment of Small Scale Genetic Manipulation Work asks for more details about any inherent risks in research proposals. The Guidelines for the Planned Release of Genetically Manipulated Organisms are also released. These replace the 1987 RDMC publication, Procedures for Assessment of the Planned Release of Recombinant DNA Organisms. The new guidelines require the gazettal of planned released proposals, their authors and organisations. Councils in the areas of release must be notified. This provides the public with an opportunity to comment; the public being able to consult GMAC’s Public Information Sheet on each proposal.

Genetic Manipulation Advisory Committee, Annual report 1992–93, op. cit., p. 10–11.

1993

Standards Australia and GMAC collaborate on the revision to the Australian Standard for Safety in Laboratories (Part 3: Microbiology) and achieve consistency with the Australian Standard and GMAC Guidelines with respect to the classification of containment levels.

Genetic Manipulation Advisory Committee, Annual Report 1993–94, op. cit., p. 28.

1993

The OECD publishes a document on the safety of GM foods using the concept ‘substantially equivalent’. This concept is adopted by Australia:

For foods and food components from organisms developed by the application of modern biotechnology, the most practical approach to the determination of safety is to consider whether they are substantially equivalent to analogous conventional food product(s), if such exist. Account should be taken of the processing that the food may undergo, as well as the intended use and the exposure. Exposure includes such parameters as the amount of food or food component(s) in the diet, the pattern of dietary consumption, and the characteristics of the consuming population(s). This approach provides a basis for an evaluation of food safety and nutritional quality.

Organisation for Economic Co-operation and Development, Safety evaluation of foods derived by modern biotechnology – concepts and principles, OECD, Paris, 1993, p. 11.

January 1994

GMAC’s Guidelines for Small Scale Genetic Manipulation Work is amended.

 

May 1994

The first GM fruit or vegetable sold in the world ( Calgene’s, later Monsanto’s Flavr Savr tomato) is produced for the Campbell Soup Company. It is cleared for sale by the US FDA but later proves to be lower-yielding than conventional varieties and not commercially viable.

L. Rothenberg and D. Mercer, ‘Public acceptance of food biotechnology in the USA’, Biotechnology and Development Monitor, No. 24, September 1995, p. 1013.

December 1994

A new edition of the Guidelines for Large Scale Genetic Manipulation Work is released. Exemptions from small-scale work are no longer automatic for large-scale proposals.

 

1994

GM agricultural and veterinary (agvet) chemicals are regulated for as agvet chemicals under the Agricultural and Veterinary Chemicals Code Act 1994(Cth).

 

1994

The Plant Variety Rights Act 1987(Cth) is replaced by the Plant Breeder’s Rights Act 1994(Cth), the new Act accommodates new technologies and is consistent with the international convention, The International Convention for the Protection of New Varieties of Plants (the UPOV Convention).

 

1994

The Australian Advisory Council on Intellectual Property is created.

 

1994–95

The GMAC Scientific Subcommittee does not accept the view of some IBCs that mandatory vaccination of researchers working with recombinant vaccinia virus should be made non-mandatory. The Committee decides on the status quo because of concerns that virulence could be transmitted to the general public by unvaccinated workers. The virus is used experimentally to introduce genes into a new host.

There are now 84 Institutional Biosafety Committees (IBCs).

GMAC contributes planned release proposals, along with Public Information Sheets and their guidelines, to the United Nations Industrial Development Organisation’s BINAS (Biosafety Information Network and Advisory Service), a database providing international information about regulations and GMO releases.

GMAC participates in an interdepartmental committee sub-group considering Article 19.3 of the Convention on Biological Diversity, which concerns the possible creation of an international protocol on biosafety.

GMAC’s Annual Report notes that proposals for GMO planned releases where plants are the host organism have increased markedly in 1994–95. Prior to 1991, the only proposals had been for micro-organisms.

Genetic Manipulation Advisory Committee, Annual Report 1994–95, op. cit., pp. 16, 31, 34, 36, 57.

April 1995

A revised edition of the Guidelines for Small Scale Genetic Manipulation Work is released. ‘Knockout’ mice are exempted from guideline requirements as long as further genetic manipulation does not occur. ‘Knockout’ mice are GM mice that may have a deleted or inactivated gene for experimental purposes.

The types of research proposals to be submitted to the NHMRC’s Gene Therapy Committee are specified in the guidelines. They are gene therapy of humans with artificially produced nucleic acids, GM micro-organisms or cells. GMAC will continue to assess proposals for clinical trials of GM vaccines intended to raise an immune response.

Genetic Manipulation Advisory Committee, Annual Report 1994–95, op. cit., pp. 8, 10.

June 1995

The Gene Technology Information Unit (GTIU) is established with a grant by the Department of Industry, Science and Technology.

Genetic Manipulation Advisory Committee, Annual Report 1995–96, GMAC, Canberra, 1996, p. 28.

July 1995

GMAC participates in the Madrid meeting of technical experts on the need to establish a biosafety protocol. The meeting agrees that a legally binding protocol is required.

Genetic Manipulation Advisory Committee, Annual Report 1995–96, op. cit., p. 12.

October 1995

A laboratory at Perth’s Sir Charles Gairdner Hospital is the first to be certified by GMAC’s Large Scale Subcommittee at the highest containment level for genetic manipulation work, namely, physical containment level PC4.

Genetic Manipulation Advisory Committee, Annual Report 1995–96, op. cit., p. 7.

November 1995

It is agreed to proceed with the development of an international biosafety protocol at the Second Conference of the Parties to the Convention on Biological Diversity. A World Bank draft report praises Australia’s system, in particular, GMAC’s guidelines.

Genetic Manipulation Advisory Committee, Annual Report 1995–96, op. cit., p. 12.

World Bank Agricultural Research and Extension Group on Environmentally Sustainable Development, Creating an enabling environment for the safe use of biotechnology, World Bank, Washington, D.C., 1995.

1995

The first three proposals for the commercial release of GMOs in Australia are received by GMAC; namely, a carnation with improved vase life, a carnation with an altered flower colour and a Bt cotton. The carnations are not considered a biosafety risk because their biology precludes gene transfer or escape into the environment. The Bt cotton merits more concern. It contains a gene from Bacillus thuringiensis that produces an insecticidal protein thus protecting the cotton from the boll worm insect pest. Until sufficient data is obtained GMAC only permits release in specified areas and on a limited scale. A major concern is gene transfer to native cotton species.

Most proposals for field trials are now for plants that are resistant to pests or specific herbicides.

In order to protect both the environment and agriculture, GMAC proposes to develop a national strategy for managing GM herbicide-resistant crops with pertinent partners, for example with the Cooperative Research Centre for Weed Management Systems.

Genetic Manipulation Advisory Committee, Annual report 1995–96, op. cit., pp. 1, 9–10.

1995

Florigene Ltd carnations are released commercially under the voluntary GMAC system.

 

1995

GMAC considers relaxing requirements for research with ‘naked DNA’; which is DNA not contained in a cell or virus.  GMAC also considers risks associated with antibiotic resistance marker genes that are used by researchers to note whether the insertion of a gene is successful. GMAC’s Scientific Subcommittee is of the view that ‘in most cases [they]will pose no significant risk’. The concern is that if an antibiotic resistant marker gene transfers to a micro-organism, the micro-organism could become antibiotic resistant and a danger if pathogenic.

Genetic Manipulation Advisory Committee, Annual report 1995–96, op. cit., pp. 6, 14.

1995

Safety Practices in PC2 Laboratories is produced to accompany Guidelines for Small Scale Genetic Manipulation Work.

 

1995–96

GMAC’s Public Liaison Sub-committee distributes an information package to secondary schools.

Genetic Manipulation Advisory Committee, Annual report 1995–96, op. cit., p. 28.

1995–1996

The National Food Authority reports that no GM foods have been approved for sale in Australia and they do not require approval as yet. Some ‘nature-identical food processing aids’ have been approved on a case-by-case basis However, they acknowledge the ‘environmental, social, ethical and religious issues and possible long-term effects of the technology’ as being consumer concerns. The Parliamentary Secretary decides that the NFA will convene a public forum in August 1996 to explore such issues.

National Food Authority, Annual report 1995–96, AGPS, Canberra, 1996, p. 19.

3 February 1996

The USFDA collates 83 adverse experience reports possibly related to the use of Posilac, a synthetic growth hormone used for lactating cows. The product is not approved for use in Australia .

US Food and Drug Administration Centre for Veterinary Medicine, BST update, media release 21 March 1996.

8 March 1996

A new edition of Guidelines for the Planned Release of Genetically Manipulated Organisms is produced. It includes more detailed information about the import and export of GMOs.

Genetic Manipulation Advisory Committee, Annual report 1995–96, op. cit., pp. 11, 16.

11 March 1996

GMAC is transferred from Administrative Services in the Department of Finance to the Department of Industry, Science and Tourism. The Hon Peter McGauran MP, the Minister for Science and Technology, becomes responsible for GMAC.

Genetic Manipulation Advisory Committee, Annual report 1995–96, op. cit., p. 11.

14 March 1996

Scientists identify a brazil nut allergen in an experimental soybean; a warning that commercialised GM food crops require careful safety assessment.

J. Nordlee et al., ‘Identification of a brazil-nut allergen in transgenic soybeans’, New England Journal of Medicine, vol. 334, no. 11, 14 March 1996, pp. 688–692.

5 July 1996

Australia and New Zealand ’s joint food standards system comes into force. Some variations will still apply.

Australia New Zealand Food Authority, Annual Report 1996–97, ANZFA, Canberra, 1997, p. xii.

July 1996

A revised edition of Guidelines for the Planned Release of Genetically Manipulated Organisms is published.

 

August 1996

110 stakeholders attend ANZFA’s forum, Gene Technology and Food – the Challenge Ahead.

Australia New Zealand Food Authority, Annual Report 1996–97, op. cit., p. 9.

6 December 1996

The Minister for Science and Technology attends a GMAC meeting where GMAC expresses the view that genetic manipulation technologies should be managed with legislation and mandatory requirements. GMAC suggests inclusions, stressing that Institutional Biosafety Committees (IBCs) should be retained, the public should be consulted and decisions should be science-based.

Genetic Manipulation Advisory Committee, Annual Report 1995–96, op. cit, pp. 3, 15–16.

1996

The Commonwealth’s chemicals regulatory body, the National  Registration Authority for Agricultural and Regulatory Chemicals (NRA), registers Bt cotton because it is insect resistant.

Genetic Manipulation Advisory Committee, Annual Report 1996–97, op. cit., p. 1.

1996

The US Department of Agriculture gives Monsanto’s Roundup Ready soybean a ‘non-regulated status’. That is, this crop does not need to be distinguished from conventional soybean varieties. The first commercial Roundup Ready soybean crop is harvested in the US.

Genetic Manipulation Advisory Committee, Annual Report 1996–97, op. cit., p. 13.

1996–97

Seed contaminated with GM soybean seed for animal feed and human food manufacturers is imported from the US . GMAC assesses that the importation does not present a significant risk.

Amendments  to Guidelines for Small Scale Genetic Manipulation Work are agreed. Research involving non-infectious ‘naked DNA’ on animals will be exempt from guideline requirements. The cloning of genes, especially to develop immuno-contraceptive agents to control feral pests will also be covered by the guidelines. The safety issue here is that there should not be infection risks in approved proposals for non-target animals or humans.

Genetic Manipulation Advisory Committee, Annual Report 1996–97, op. cit., pp. 10, 11, 13.

3 Feb 1997

Releasing a draft food Standard A18 for foods developed using genetic engineering Senator Bob Woods announces that GM foods will be prohibited until the standard prepared by the Australia New Zealand Food Authority (ANZFA, formerly the NFA) is finalised. A public consultation takes place prior to the ANZFA Board re-examining the draft standard. 430 submissions are received.

B. Woods, (Parliamentary Secretary for the Department of Health and Family Services), Guidelines for genetically modified foods, media release, 3 February 1997.

5 February 1997

ANZFA releases an information paper about the assessment of GM foods. The paper enumerates the need to consider both intended and unintended effects arising from gene technology and sets out decision trees for assessment of foods on a case-by-case basis. It also considers labelling options and overseas practices.

The Draft Standard A18 is included in the Explanatory Notes to Proposal P97 that is released on this day. The Explanatory Notes provide information about ANZFA’s approach to developing the GM food standard.

Australia New Zealand Food Authority, Assessment guidelines for foods and food ingredients to be included in Standard A18 – Food derived from gene technology, op. cit., pp. 11–17, 19–23.

14 April 1997

ANZFA receives a Monsanto application for oil and linters derived from four insect-resistant cotton lines to be approved as foods and included in Table 2 of the anticipated GM food standard, Standard A18 of Australia’s Food Standards Code. Linters are short cotton fibres and their cellulose content is  used in food products such as ice-cream.

Australia New Zealand Food Authority, Full assessment report and regulatory impact assessment: A341 Oil and linters derived from insect resistant cotton, ANZFA, Canberra, 1998.

April 1997

Australia provides a Sanitary and PhytoSanitary Notification regarding the Standard A18 proposal, P97, as required, to the World Trade Organisation.

Australia New Zealand Food Authority, Foods produced using gene technology, 6th ed., ANZFA, Canberra, June 1999.

May 1997

Australia is represented at the Montreal meeting of the Open-Ended Ad Hoc Working Group on Biosafety.

Genetic Manipulation Advisory Committee, Annual Report 1996–97, op. cit., pp. 3, 33.

July 1997

GMAC launches its web page.

Genetic Manipulation Advisory Committee, Annual report 1996–97, op. cit., 1997, pp. 3,34.

September 1997

GMAC approves a CSIRO proposal, namely, the planned release  field trial of two gene INGARD cotton that carries tolerance to the herbicide glyphosate and resistance to insect pests. GMAC concludes that it does not pose a significant environmental risk.

Genetic Manipulation Advisory Committee, PR-81: The planned release of INGARD cotton expressing glyphosate tolerance and CryIIA, GMAC, Canberra, 1997.

October 1997

Ministers Anderson, Hill and Moore announce the Commonwealth Government’s position on genetic engineering regulation. It includes the establishment of a Gene Technology Office and a national regulation system.

J. Anderson, (Minister for Primary Industries and Energy), R. Hill (Minister for the Environment) and J. Moore (Minister for Industry, Science and Tourism), New regulatory system for gene technology’, Department of Primary Industries and Energy, media release , 30 October 1997.

12 December 1997

ANZFA receives Monsanto’s application to have GM cotton line 1445 approved for food use, namely cottonseed oil and linters.

Australia New Zealand Food Authority, Draft risk analysis report, Application A355: Food produced from glyphosate-tolerant cotton line 1445, ANZFA, Canberra, 2000, p. 3.

15 December 1997

The Agriculture and Resource Management Council of Australia and New Zealand (ARMCANZ) maps ‘gaps and problems’ in Australia’s regulatory arrangements and suggests modifications.

Agriculture and Resource Management Council of Australia and New Zealand, Regulation of Gene Technology, ARMCANZ, Canberra , 1997.

1997

CSIRO scientists, Drs Peter Waterhouse and Ming-Bo Wang, discover DNA-directed RNA interference-mediated gene silencing in tobacco, and how it works. This heralds a second-wave in genetic engineering technology using ddRNAi technology.

Waterhouse and Wang identify this viral defence mechanism within plant cells which holds the promise of protecting crops from viral attack: ‘Although the Nobel Prize went to Fire and Mello [in 2006], Waterhouse and Wang seem destined to be credited with engineering an agricultural revolution.’

The Bulletin Smart 100’, Bulletin with Newsweek, 26 June 2007, pp. 77 – 79.

1997

The Joint NHMRC/AVCC Statement and Guidelines on Research Practice is released.

 

24 February 1998

Chairwoman Winsome McCaughey explains  ANZFA’s GM food labelling standard decision. The Australian Food Council’s Mitchell Hooke approves the decision while Bob Phelps of the Australian GeneEthics Network questions the decision on public health and consumer choice grounds.

Australia New Zealand Food Authority, ‘Australia New Zealand Food Authority makes recommendation to health ministers on regulation of foods produced using gene technology’, media release, ANZFA, 24 February 1998.

S. Bull, ‘ANZFA releases genetically modified food standards plan’, AAP, 24 February 1998.

25 February 1998

ANZFA releases its recommendations for the inclusion of a GM food standard in the Food Standards Code.

Australia New Zealand Food Authority, Statement of reasons. Proposal P97 for recommending Standard A18 –foods produced using gene technology,  ANZFA,   Canberra, 1998.

 

The Australian Consumers’ Association (ACA) protests that consumers’ needs are being ignored in ANZFA’s recommendation that ‘substantially equivalent’ GM foods should not require mandatory food labelling.

Consumers group attacks genetically modified food plan food’, AAP news, 25 February 1998.

24 March 1998

GMAC approves the release of Roundup Ready cotton under ‘planned release conditions’ applying to previous field trials. It notes the risk that transgenic cotton genes could transfer to native cotton species (Gossypium).

Unrestricted release of herbicide-resistant crops is not permitted until a national strategy for such crops is in place.

GMAC’s Public Information Sheet indicates that the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) is examining Monsanto’s application for the Roundup herbicide and that ANZFA is considering an application for oil from Roundup Ready cotton to be approved for food use and included in the proposed food standard, Standard A18.

Genetic Manipulation Advisory Committee  ‘PR-83X(2) (originally notified as GR-4): Evaluation of Roundup Ready cotton grown under commercial use conditions’, GMAC Public Information Sheet on planned release proposals, 1998.

March 1998

The Australia New Zealand Food Standards Council (ANZFSC ) gives permission for foods containing GM ingredients to remain on sale in Australia until assessed by the Council, if applications are submitted by April 30.

R. Polya, ‘Genetically Modified Foods - Are We Worried Yet?’, Current Issues Brief, no. 12, Parliamentary Library, Canberra, 1998–99, p. 2.

April 1998

Guidelines for Small Scale Genetic Manipulation Work, and Guidelines for the Deliberate Release of Genetically Modified Organisms and Guidelines for Activities with the Potential for Unintended Release of Genetically Modified organisms are released.

The draft Points to be Considered in Developing Genetically Modified Crops and Pastures for Agriculture is prepared and circulated as a result of discussions by a Working Group of the Standing Committee on Agriculture and Resource Management (SCARM). The Working Group was set up to prepare guidelines for the agricultural use of GM crops.

Genetic Manipulation Advisory Committee, Annual report 1997–98, op. cit., p. 32.

30 July 1998

Standard A18: Food Produced Using Gene Technology is agreed to by the Australia and New Zealand health ministers, ANZFSC, chaired by Trish Worth, the Parliamentary Secretary for the Department of Health and Family Services. Under the standard, those wishing to sell foods produced using gene technology must apply to Australia ’s food authority, ANZFA, for approval to do so. The health ministers agree that GM food not assessed as ‘substantially equivalent’ should be labelled. There is considerable controversy about this FAO/WHO concept. Foods assessed to have equivalent composition and nutritional quality and no change in allergenicity potential are deemed to be ‘equivalent’. In Australia, Monsanto’s Roundup Ready soybeans and Ingard cottonseed oil are assessed by ANZFA as being ‘substantially equivalent’.

Food Standards Council, Australia New Zealand Food Standards Council sets major direction for the future of food, media release, 30 July 1998.

Australia New Zealand Food Authority, Foods produced using gene technology, op. cit.

Food and Agricultural Organisation, Biotechnology and food safety: Report of a joint FAO/WHO Consultation, Rome, Italy, 30 September–4 October 1996, FAO, 1996, pp. 4–5.

11 August 1998

A peak agricultural chemical body, Avcare, shows the Release Sub-committee, a GMAC committee that examines proposals for the release of GM crops, their proposed strategy for herbicide-resistant crops in Australia. Avcare subsequently develops guidelines with the Cooperative Research Centre for Weed Management Systems.

Genetic Manipulation Advisory Committee, Annual report 1997–98, op. cit., p. 17.

13 August 1998

Australia’s first regulations for foods produced using genetic engineering are gazetted; namely, Standard A18 of the Food Standards Code. They will not come into force until 1999.

Australia New Zealand Food Authority, Foods produced using gene technology, op. cit. p. 1.

August 1998

With some disappointment about the efficacy of single gene cotton, the 1997–98 trials of the more effective two-Bt breeding lines are examined for their potential in Australian agriculture.

G. Constable, ‘Two gene technology in the Australian scene’, Proceedings of the 9th Australian Cotton Conference August 1998, ACGRA, 1998.

September 1998

The US FDA releases their draft guidance on the use of antibiotic- resistance marker genes for crop developers. This is to avoid the possibility of antibiotics in medical therapies being compromised because of the use of inappropriate antibiotic resistant markers in GM crop development.

US Food and Drug Administration Centre for Food Safety and Applied Nutrition, Guidance for industry: Use of antibiotic resistance marker genes in transgenic plants - Draft Guidance, FDA, 1998.

18 October 1998

Senator the Hon. Nick Minchin becomes Minister for Industry, Science and Resources and thus responsible for GMAC.

J. Howard (Prime Minister), Second Howard Ministry, media release, 18 October 1998.

November 1998

The Commonwealth State Consultative Group on Gene Technology releases a paper exploring regulatory options for genetic engineering in Australia in a limited public consultation.

Commonwealth State Consultative Group on Gene Technology Regulation of gene technology, CSCGT, Canberra, 1998.

9 December 1998

The United Nations General Assembly endorses the Universal Declaration on the Human Genome and Human Rights with Resolution AIRES/53/152.

 

17 December 1998

ANZFSC decides with a six to four vote that, in addition to approved GM foods that are not equivalent to conventional foods already regulated for under the proposed Standard A18 of the Australian Food Standards Code, ‘substantially equivalent’ GM goods should also be labelled for the benefit of consumers.

ANZFA acknowledges ‘intense media interest’ in GM foods and the problem of being able to be seen as impartial when the onus is on ANZFA to both assess the technology and also provide public education on a complex scientific issue. ANZFA reports:

We have not, of course, reached the end of the public debate on genetically modified food. It is a subject which will continue to be hotly debated over the coming years.

Australia New Zealand Food Standards Council, Health ministers decide key food issues, media release, 17 December 1998.

Australia New Zealand Food Authority, Annual Report 1998–99, ANZFA. Canberra, 1999, pp. 51–52.

17 December 1998

Protests about GM ingredients in foods in the UK are particularly strong. European Union directives on GM food labelling are strengthened.

R. Polya, ‘Genetically Modified Foods - Are We Worried Yet?, op. cit. p. 1.

December 1998

In response to the election promise for a Consultative Group and a Biotechnology Action Agenda Minister Minchin announces the industry membership of the Biotechnology Consultative Group.

N. Minchin (Minister for Industry, Science and Resources), Minister announces industry membership of Biotechnology Consultative Group, media release, 22 December 1998.

December 1998

The Australian Quarantine Inspection Service (AQIS) proposes interim arrangements for the importation of GM plants pending the development of regulations. Under the World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement), AQIS may reject plants, whether GM or artificially selected, that pose an environmental or health  risk.

Australian Quarantine and Inspection Service, Regulation of plants that have been genetically manipulated or artificially selected, AQIS, Canberra, 1998.

1998

Proposals for the release of herbicide-resistant crops (for example, AgrEvo Pty Ltd’s proposal PR-85 for canola with a tolerance to the herbicide glufosinate ammonium) are delayed by GMAC until a national strategy is in place for such crops. GMAC’s concern is that there could be a potential for the emergence of herbicide-resistant weeds, gene transfer from GM canola to weeds and excessive use of glufosinate ammonium. Accordingly, proposals for the general release of Roundup Ready cotton (GR-4) and glufosinate ammonium tolerant canola (GR-5) are to be examined for planned release rather than general release. That is, field trial conditions are to be observed.

Genetic Manipulation Advisory Committee, Annual Report 1997–98, op. cit., pp. 17, 22, 29.

1998

ANZFA releases its findings on stakeholders’ views about GM foods.

Australia New Zealand Food Authority, ‘Stakeholder views from a public consultation on the labelling of foods produced using gene technology’, ANZFA Fact Sheet, ANZFA, Canberra, 1998.

1998–99

A proposal for a clinical trial of an HIV-AIDS vaccine, a GM fowl pox virus, is submitted to GMAC and is found to pose no risk to the community. There is some potential for the vaccine organism to be disseminated from the vaccinated patients. This is the first proposal for a GM vaccine to GMAC. All such proposals must be examined by the NHMRC’s Gene Therapy Research Advisory Panel (GTRAP) as well as GMAC.

The Scientific Sub-committee discusses risks associated with virus resistant plants and agrees to monitor developments. Security arrangements for GM mice and the new ‘Cre-lox’ technique for the removal of specific genes are examined.

Genetic Manipulation Advisory Committee, op. cit. pp. 10, 12, 14, 15.

1998–1999

FSANZ assesses as suitable Monsanto’s application for oil and linters from four GM insect-resistant Bt cotton lines to be used for foods as suitable. Because it is not likely that novel genetic material will be present in the final foods using oil and linters GM labelling will not be required.

Australia New Zealand Food Authority, Full assessment report and regulatory impact assessment, A341 Oil and linters derived from insect resistant cotton, ANZFA, Canberra, 1999.

17 February 1999

ANZFA deems Roundup Ready soybeans and Ingard Cotton seeds  to be substantially equivalent to their conventional counterparts. Ingard cotton is grown in Australia but the GM soybeans are imported. After public consultation ANZFSC will consider their approval in Australia ’s food supply at their April 1999 meeting. Also being considered by ANZFA are Roundup Ready canola, cotton and corn lines and a Bt corn.

Australia New Zealand Food Authority, ANZFA completes assessment for first two genetically modified foods in Australia and New Zealand, media release, 17 February 1999.

February 1999

The Miami Group, comprising those countries growing genetically modified products (Argentina, Australia, Canada, Chile, Uruguay and the US), want co-mingling of living modified organisms (LMOs) and non-LMO grain permitted in international trade. The Group also does not wish the Cartagena Protocol on Biosafety to over-ride other trade agreements such as those of the World Trade Organisation (WTO). That is, the Miami Group does not wish countries to have the right to create a trade barrier against LMO products. For instance, if the WTO agreements are to retain ascendancy over the Protocol, countries such as the EU could have sanctions applied against them if they do not comply with WTO rulings.

A. Kedgley Laidlaw, ‘Is it better to be safe than sorry?’, Victoria University of Wellington Law Review, vol. 36, no. 2, 2005.

February 1999

The final text of the Protocol provides a compromise solution.

Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes. Montreal,

Secretariat of the Convention on Biological Diversity, 2000.

24 March 1999

The Shadow Minister for Consumer Affairs, Lindsay Tanner criticises the Government’s gene labelling attempts given that only two companies have applied for permission to sell GM foods. He reveals that at the December six to four vote by ANZFSC, the Commonwealth Government and Victoria had voted against labelling ‘substantially equivalent’ GM foods.

L. Tanner (Shadow Minister for Consumer Affairs), Gene labelling – government falls at first hurdle, media release, 24 March 1999.

March 1999

The Commonwealth’s Standing Committee on Agriculture and Resource Management (SCARM) produces GM crop agricultural guidelines for farmers and their advisers and provides an overview of current regulation.

Commonwealth-State Standing Committee on Agriculture and Resource Management, Good agricultural practice guidelines for the use of genetically modified plants, SCARM, Canberra, March 1999.

March 1999

With the growing Australian debate about GM foods a conference is convened in Canberra for interested stakeholders by the Australian Museum.

First Australian Consensus Conference on Gene Technology in the Food Chain, Lay Panel Report, Australian Museum, 1999.

30 April 1999

The ministerial council, ANZFSC, decides that foods produced before 30 April 1999 may remain on sale after Standard A18 comes into force, provided the manufacturers have submitted an application for a safety assessment by this date, that the food has been lawfully sold overseas and that ANZFA has no evidence that the product is unsafe.

ANZFA receives 20 applications for approval for sale of GM foods derived from specific lines of soy beans, corn, cotton, sugar beet, canola and potatoes.

Australia New Zealand Food Authority, Annual Report 1998–99, ANZFA, Canberra, 1999, p. 20.

11 May 1999

GMAC is transferred from the Department for Industry, Science and Resources to the Department for Health and Aged Care and will continue to be administered by the Department after the establishment of the Interim Office of the Gene Technology Regulator.

The Budget provides $17.5 million to establish a new biotechnology strategy; the Ministerial Council on Biotechnology has carriage of it.

Genetic Manipulation Advisory Committee, Annual Report 1998–99, GMAC, Canberra, 1999, p. 40.

N. Minchin, Minister for Industry, Science and Resources Funding for biotechnology strategy, media release, 11 May 1999.

13 May 1999

Standard A18 of the Australian Food Standards Code comes into force. Foods produced using gene technology must be approved by ANZFSC after assessment by FSANZ. GM foods must be labelled if not ‘substantially equivalent’ to conventional foods.

Australia New Zealand Food Authority, Foods produced using gene technology, edition 6. ANZFA, Canberra, 1999.

May 1999

Expatriate Australian scientist, Sir Robert May, in his capacity as UK’s Chief Scientific Adviser, concludes that there is no evidence that GM food is harmful. However, he suggests close monitoring of developments and that transparency of UK GM regulatory matters be improved.

L. Donaldson and R. May, Health implications of genetically modified foods, Ministerial Group on Biotechnology London, 1999.

May 1999

A pro GM public relations consortia, Agrifood Alliance Australia, is formed to counteract lobbying against GM foods by organisations such as the Public Health Association of Australia. It comprises seven organisations supportive of the promise of GM technologies; namely, the National Association of Crop Production and Health, the Grains Research and Development Corporation, the Seed Industry Association, the National Farmers’ Federation, the Australian Biotechnology Association, the Cooperative Research Centres Association and Pivot Limited.

‘”Blitz” on modified food’, The Canberra Times, 18 May 1999.

A. Wahlquist, ‘Farmers seek right medium for message on “Frankenstein foods”’, The Australian, 21 May 1999.

May 1999

Biotechnology Australia is established. It comprises Commonwealth departmental partners; namely, the Departments of Agriculture, Fisheries and Forestry; Education, Science and Training; Environment and Heritage; Health and Ageing; and Industry, Tourism and Resources. The agency reports to the Biotechnology Ministerial Council .

 

May 1999

The United Nation's Codex Alimentarius meeting in May 1999 sees a rejection by Australia and others of the US-led resistance to compulsory labelling of GM food in the first stage vote on the proposed international draft labelling standard for GM foods.

R. Polya, ‘Genetically Modified Foods - Are We Worried Yet?’, op. cit., p. 4.

3 August 1999

ANZFSC agrees to further labelling of GM foods with new amendments to the standard to be re-examined in October 1999. ANZFA is requested to address a range of issues, including consumer information issues in labelling amendments, standard compliance costs and threshold levels of GM ingredients for both general and highly processed foods

Australia New Zealand Food Standards Council, Health Ministers agree to extend labelling of genetically modified food in Australia and New Zealand, media release, 3 August 1999.

22 August 1999

The Minister for Health and Aged Care announces that in addition to GMAC’s oversight of research into GMOs, the Interim Office of the Gene Technology will manage the commercialisation of GMOs. A permanent office will be established by 3 January 2001 and will be responsible for regulation of GMOs where no other regulatory agency has pre-existing responsibilities. It will also work with such agencies to harmonise regulatory arrangements.

G. Tambling (Parliamentary Secretary for Health and Aged Care), The regulation of genetically modified (GM) foods, media release, Brisbane, 27 August 1999.

27 August 1999

Senator Grant Tambling explains the 3 August ANZFSC decision to extend GM labelling to all foods produced using gene technology.

G. Tambling (Parliamentary Secretary for Health and Aged Care), The regulation of genetically modified (GM) foods, media release, Brisbane, 27 August 1999.

26 October 1999

The Parliamentary Secretary for Health and Aged Care, Senator the Hon Grant Tambling, announces the ANZFSC decision of 22 October; namely, that ANZFA should produce a protocol for the implementation and enforcement of Standard A18 and that testing of foods will only be required where there is insufficient documentation. The KPMG costing of the introduction of GM labelling is not accepted.

G. Tambling (Parliamentary Secretary for Health and Aged Care), Food ministers make further progress with food standards , media release, 26 October 1999.

KPMG, Report on the compliance costs facing industry and government regulators in relation to labelling genetically modified foods, KPMG, Canberra, 1999.

October 1999

The Commonwealth Interim Office of the Gene Technology Regulator (IOGTR) releases an overview of the existing regulatory process, as well as providing a web page Consultations on Gene Technology Regulation with links to fact sheets, questions and answers and key documents.

Interim Office of the Gene Technology Regulator, Overview: Current regulatory and administrative arrangements for controlling genetically modified organisms in Australia, October 1999, Department of Health and Aged Care, Canberra, 1999.

October 1999

The Commonwealth Interim Office of the Gene Technology Regulator releases a discussion paper on the regulation of GMOs.

Interim Office of the Gene Technology Regulator, Discussion paper: Proposed national regulatory system for genetically modified organisms. How should it work? (Draft for comment) October 1999,  IOGTR, Canberra, 1999.

1 December 1999

The completion of the Human Genome Project’s sequencing of the first human chromosome, human chromosome 22, is announced. This provides researchers with a library to draw upon for future gene technology research and a key to future therapies.

US Department of Energy Office of Science, Major events in the U.S. Human Genome Project and related projects, US DOE, 2008.

8 December 1999

Senator Stott Despoja announces that the Democrat’s amendments to the Australia New Zealand Food Authority Amendment Bill (No. 2) 1999 will clarify:

… education initiatives of ANZFA to include the publication of information to increase public awareness of food standards and food labels were successful. Consumers must know, especially with the approval of novel food products such as GM and irradiated foods, what they are eating.

N. Stott Despoja, Democrats improve ANZFA, media release, 8 December 1999.

1999

The Commonwealth’s Draft Gene Technology Bill 2000 is released in December.

 

1999

An ABARE author explores the role of the Australian government in encouraging the uptake of gene technology in agriculture.

M. Foster et al., ‘Plant gene technology: Australia’s competitiveness and the role for government’, Outlook Conference 17–18 March 1999, Outlook 1999.

1999

During 1999 GM tomatoes, developed in the UK by Professor Grierson of Nottingham University with Zeneca Seeds are withdrawn from sale because of public opposition to GM foods. They had been on sale in the UK since 5 February 1996.

D. R. Madden, ‘Genetically-modified tomatoes’, University of Reading, 1999.

1999

Guidelines for the introduction of GM crops are released so as to inform developers and growers of GM crops.

Agriculture and Resource Management Council of Australia and New Zealand, Good agricultural practice guidelines for the use of genetically modified plants, ARMCANZ, Canberra, 1999.

 

 

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