Required Report - public distribution

**Date:** 7/14/2005

**GAIN Report Number:** AS5024

AS5024

**Australia**

**Biotechnology**

**Agricultural Biotechnology Annual Report**

**2005**

**Approved by:**

![](media/image1.wmf)Andrew C. Burst

U.S. Embassy

**Prepared by:**

Lindy Crothers

**Report Highlights:**

The United States has substantial interest in Australia's policies and
regulatory framework regarding agricultural biotechnology and products
derived thereof. Unprocessed (whole) biotech corn and soybeans have not
received regulatory approval in Australia and, thus, cannot be imported
without further processing. Foods with biotech content must receive
prior approval and be labeled if biotech content is more than 0.1%. This
requirement can restrict sales of U.S. intermediate and processed
products. Australia's policies and views on this technology influence
other countries in the region, and elsewhere, which may follow
Australia's lead in developing a regulatory system of their own.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Canberra \[AS1\]

\[AS\]

Table of Contents

[**Section I: Executive Summary 3**](#section-i-executive-summary)

[Section II: Biotechnology Trade and Production
4](#section-ii-biotechnology-trade-and-production)

[Commercial Crops 4](#commercial-crops)

[Applications Under Evaluation 5](#applications-under-evaluation)

[Imported Products 5](#imported-products)

[Section III: Biotechnology Policy 6](#section-iii-biotechnology-policy)

[The GMO Regulatory System 6](#the-gmo-regulatory-system)

[GMOs vs GM Product 7](#gmos-vs-gm-product)

[GMOs Already Licensed by OGTR 7](#gmos-already-licensed-by-ogtr)

[Biotech Food 7](#biotech-food)

[Biotech Feed Products 7](#biotech-feed-products)

[Coexistence Between Biotech & Non-Biotech Crops
8](#coexistence-between-biotech-non-biotech-crops)

[Biosafety Protocol 8](#biosafety-protocol)

[Section IV: Marketing 9](#section-iv-marketing)

[Market Acceptance 9](#market-acceptance)

[National Biotechnology Strategy 9](#national-biotechnology-strategy)

[Biotechnology Australia 10](#biotechnology-australia)

[National Farmers Federation 10](#national-farmers-federation)

[Country Specific Studies Relevant to U.S. Exporters
11](#country-specific-studies-relevant-to-u.s.-exporters)

[Section V: Reference Material 11](#section-v-reference-material)

[Appendix I: GMO Applications Under Evaluation
12](#appendix-i-gmo-applications-under-evaluation)

[Appendix II: GMOs Already Licensed for Use in Australia
13](#appendix-ii-gmos-already-licensed-for-use-in-australia)

[Appendix III: Approved GM Food Products
17](#appendix-iii-approved-gm-food-products)

#   {#section .unnumbered}

# Section I: Executive Summary

The United States has substantial interest in Australia's policies and
regulatory framework regarding agricultural biotechnology and products
derived thereof. Unprocessed (whole) biotech corn and soybeans have not
received regulatory approval in Australia and, thus, cannot be imported
without further processing. Foods with biotech content must receive
prior approval and be labeled if biotech content is more than 0.1%. This
requirement can restrict sales of U.S. intermediate and processed
products. Australia's policies and views on this technology influence
other countries in the region, and elsewhere, which may follow
Australia's lead in developing a regulatory system of their own.

Overall, the Australian government is supportive of the use of
agricultural biotechnology and has committed long-term funding to
research and development. The State governments have also committed
funds for research and development, but most are being more cautious
about the introduction of the technology and are using their powers over
'marketing' to restrict biotech crops in their jurisdictions. Major farm
groups and the Commonwealth government's science organizations do not
support this position and have argued openly for its acceptance.

Australia has a substantial risk assessment based regulatory framework
for dealings with gene technology and genetically modified organisms, as
well as a process for assessment and approval of genetically modified
foods. The Gene Technology Act of 2000 established Australia's
regulatory scheme for dealings with gene technology and genetically
modified organisms (GMOs). The Commonwealth's Gene Technology Regulator
serves the key role in assessing, regulating and licensing GMOs and
enforcing license conditions. Genetically modified foods must also be
assessed, determined to be safe, and be approved before being sold for
human consumption. The standards for such foods are developed by Food
Standards Australia New Zealand (FSANZ) and are contained in the Food
Standards Code. There are labeling requirements for genetically modified
foods containing modified genetic material and/or novel protein, and for
foods with altered characteristics. Imports of viable GMOs and food
products containing genetically modified ingredients would need to meet
these same regulations.

To date, biotech cotton, carnations and canola varieties are the only
agricultural crops approved for commercial release into the environment
in Australia, while biotech cotton is the only crop grown widely in the
country. Research is being conducted on other biotech crops, with field
trials controlled by the Office of the Gene Technology Regulator (OGTR)
being conducted on some, i.e., rice, white clover, narrow-leafed lupin,
grapevines, pineapple, papaya, sugarcane and poppies. Approval has
already been granted for food products derived from biotech corn,
soybean, sugarbeet, potatoes and oils from biotech cotton and canola.

For GMOs that have not received regulatory approval in Australia, U.S.
export opportunities are, obviously, restricted. For the United States,
the commercial impact of this constraint is most pronounced for feed
grain, e.g. whole corn, and soybeans. Furthermore, bans and restrictions
on the growing of GMOs in a number of Australian states and territories
is slowing the commercialization and adoption of the technology and
negatively impacts the ability of a U.S. company (Monsanto) to market
one of their GMO products (canola).

Australia's regulatory framework for genetically modified food and feed
has only a relatively limited impact on U.S. exports of these products.
Australia requires that food products derived from GMOs, if they contain
more than 0.1% of biotech product, get prior approval from Food
Standards Australia New Zealand before they can be sold. Such products
must also be labeled to indicate that they contain biotech products.
Often, Australia does not allow the importation of many grains and/or
grain products for phytosanitary reasons, rather than the fact that they
are genetically modified.

In addition to Australia's regulatory framework for biotechnology, a
government agency -- Biotechnology Australia (BA) -- coordinates
non-regulatory biotechnology issues for the Australian Government. BA, a
multi-departmental agency, includes members from the Australian
Departments of Industry, Tourism and Resources; Health and Ageing;
Agriculture Fisheries and Forestry; Environment Australia; and
Education, Science and Training. BA is responsible for developing and
implementing Australia's National Biotechnology Strategy (NBS). The NBS
supports the Government's vision for biotechnology -- capturing the
benefits of biotechnology for the Australian community, industry and
environment, consistent with safeguarding human health and ensuring
environmental protection.

# Section II: Biotechnology Trade and Production

## Commercial Crops

Biotech cotton, color modified carnations and canola are the only crops
approved for commercial release by Australia's Gene Technology
Regulator. Biotech cotton varieties are estimated to be grown on about
80 percent of Australia's cotton area. The Regulator approved the
commercial releases of two biotech canola varieties in 2003. However,
commercial plantings of biotech canola are being held up due to
moratoriums that have been implemented by state governments in all
Australia's major canola producing states.

[Biotech Cotton]{.underline}

Biotech cotton has been grown commercially in Australia since the
approval and introduction of Bt, or Ingard, cotton in 1996. 'Ingard'
cotton contains a gene from a soil bacteria, Bacillius thuringiensis, or
Bt, that provides insect resistance. Commercial plantings of 'Ingard'
cotton in Australia were restricted to 30 percent of total cotton area
for insect resistance management purposes. Australia's Commonwealth
Scientific Industrial Research Organization (CSIRO) developed 'Ingard'
cotton, using a gene owned by Monsanto.

Roundup Ready cotton (herbicide tolerance) and Roundup Ready/Bt cotton
(herbicide tolerance/insect resistance) were subsequently approved and
grown commercially for the first time in 2001. Roundup Ready/Bt cotton
was developed using conventional breeding of the two GMO varieties.

In 2003, Australia's Gene Technology Regulator approved an additional
cotton variety -- 'Bollgard II' -- for commercial release and the first
major commercial plantings were made during the 2003/04 season.
'Bollgard II' contains two 'Bt' genes (as opposed to the one in 'Ingard'
cotton), which delays the development of insect resistance to the Bt
toxin. 'Bollgard II' is being phased in as 'Bt' cotton is phased out.
Once 'Bt' cotton is phased out, 'Bollgard II' can be used on up to 80
percent of Australia's cotton area which is equivalent to about 250,000
hectares. 'Bollgard II' was developed by CSIRO using genes under license
from Monsanto.

In addition, there are a number of biotech cotton varieties that are
currently undergoing trials. These include insect-resistant and
herbicide-tolerant varieties, as well as a high oleic acid content
variety being developed by CSIRO.

CSIRO analysis indicates that 'Bt' cotton allowed Australia's cotton
farmers to reduce pesticide applications by about 50 percent, compared
to conventional cotton varieties. CSIRO research shows that 'Bollgard
II' will reduce pesticide applications by up to 75 percent.

Australian food standards require approval and labeling of food or food
ingredients that contain new genetic material or protein or have altered
characteristics as a result of gene modification. Refined oil from
biotech cottonseed, however, does not require a label because the oil
contains no genetic material and the cottonseed oil is identical to
conventional cottonseed oil.

[Carnations]{.underline}

Biotech carnations, modified for flower color, were approved for general
release in Australia in September 1995 under the former voluntary system
(GMAC). Biotech carnations have been commercially available in Australia
since 1996. Only one company, Florigene, is licensed to grow biotech
carnations and it is believed that they are the only company in the
world dealing with biotech carnations. Currently five genetically
modified carnations are being grown.

[Canola]{.underline}

The commercial releases of two biotech canola varieties (InVigor^®^
hybrid & Roundup Ready^®^) were approved by OGTR in 2003. However,
commercial plantings of these varieties are being held up due to
moratoriums that have been implemented by state governments in all
Australia's major canola producing states. As a result of the bans,
Monsanto has withdrawn from the Australian market for their Roundup
Ready^®^ canola product.

## Applications Under Evaluation

A list of GMO applications currently under evaluation by OGTR is
contained in Appendix I of this report.

## Imported Products

Under the Gene Technology Act 2000, approval or authorization must be
obtained to deal with genetically modified organisms. This means that
the importation of live, viable GMOs, are regulated under the Act.
Importers need to apply to OGTR for a license or authorization to import
any GMO into Australia. OGTR and the Australian Quarantine and
Inspection Service (AQIS) work closely to regulate and enforce this
situation. The AQIS application form for an import permit now contains a
section relating to the genetically modified status of the product.

Foods containing biotech materials must be approved by Food Standards
Australia New Zealand and be labeled if the biotech content is greater
than 0.1% before they can be sold in Australia. This applies to all
domestically produced and imported food. A list of currently approved
biotech food products is contained in Appendix III of this report.

Processed animal feeds, such as soy meal, are not covered by biotech
legislation in Australia. These products, therefore, do not require
prior approval or a license (see Section III of this report) to be
imported. There are, however, quarantine restrictions on some products.
Unprocessed biotech products imported as feed (i.e. whole grain, etc),
would require a license from OGTR, as there is a possibility that seed
could be released into the environment.

# Section III: Biotechnology Policy

## The GMO Regulatory System

The Gene Technology Act 2000 (the Act) came into force on June 21, 2001
as the Commonwealth component of a national regulatory scheme. The Act
and the associated Gene Technology Regulations 2001, provide a
comprehensive process for the Gene Technology Regulator to assess
proposed dealings with live and viable GMOs ranging from contained work
in certified laboratories to general releases of GMOs into the
environment, and extensive powers to monitor and enforce license
conditions. An Inter-Governmental Agreement, between the Commonwealth
and the states and territories, underpins the system for regulating
genetically modified organisms in Australia. The Ministerial Council for
Gene Technology, comprising ministers from the Commonwealth and each
state and territory, oversees the regulatory framework and provides
advice to the Gene Technology Regulator on policy principles to assist
in decision-making. The individual states and territories have passed or
are developing complimentary legislation to the Gene Technology Act in
their jurisdictions.

The object of the Gene Technology Act is: \"To protect the health and
safety of people, and to protect the environment, by identifying risks
posed by or as a result of gene technology, and by managing those risks
through regulating certain dealings with genetically modified
organisms.\"

The Act prohibits all dealings with GMOs unless the dealing is:

-   A licensed dealing;

-   A notifiable low risk dealing;

-   Exempt dealing; or

-   Included on the GMO Register.

Key features of the Act are the appointment of an independent Gene
Technology Regulator and a requirement for transparent and accountable
implementation. The Regulator administers the regulation of all dealings
with GMOs in Australia, in accordance with the Act and ensures
compliance with the conditions of any approvals. The Regulator consults
extensively with the community, research institutions and private
enterprise.

The Gene Technology Regulator liaises with other regulatory agencies,
including the Australian New Zealand Food Authority (ANZFA), the
National Registration Authority for Agricultural and Veterinary
Chemicals (NRA), and the Therapeutic Goods Administration (TGA), to
coordinate the approval of biotech products for use and sale. The Act
creates a Public Record of GMO Dealings and GM Products that resides on
the OGTR website: [www.ogtr.gov.au](http://www.ogtr.gov.au/).

The Act also establishes three committees to advise the Regulator and
the Ministerial Council:

-   The Gene Technology Technical Advisory Committee (GTTAC) -- a group
    of highly qualified experts who provide scientific and technical
    advice on applications;

-   The Gene Technology Ethics Committee (GTEC) -- a group of expert
    ethicists, which provides ethical advice, particularly in the areas
    of law, religious practices, animal welfare and population health;
    and

-   The Gene Technology Community Consultative Committee (GTCCC) -- a
    group of people representing the broad interests within the
    Australian community, including consumers, researchers, and
    environmentalists. This group looks beyond the science of gene
    technology to matters of general concern to the community in
    relation to GMOs.

## GMOs vs GM Product

The Gene Technology Act 2000 distinguishes between genetically modified
organisms (GMOs) and genetically modified (GM) products. A genetically
modified product 'GM product' means a thing (other than a GMO) derived
or produced from a GMO (Section 10 of the GT Act).

The Office of the Gene Technology Regulator (OGTR) does not directly
regulate the use of GM products in Australia. However, the use of GM
products is regulated by other regulatory agencies in a number of
situations. Food Standards Australia New Zealand (FSANZ) regulates the
use of GM products in food for human consumption, and the Therapeutic
Goods Administration regulates the use of GM products as human
therapeutics. The National Industrial Chemical Notification and
Assessment Scheme (NICNAS) regulates any GM products derived from
industrial chemicals and the Australian Pesticides and Veterinary
Medicines Authority (APVMA) evaluates and approves pesticides and
veterinary medicines containing GM products.

## GMOs Already Licensed by OGTR

A list of GMOs already licensed by OGTR is contained in Appendix II of
this report.

## Biotech Food

Food Standards Australia New Zealand (FSANZ) is the Australian
Government agency responsible for approving GM food products for the
Australian market. Mandatory labeling of genetically modified foods,
where introduced DNA or protein is present in the final food, came into
force in Australia on December 7, 2001. Regulations for labeling are
contained in [Standard
1.5.2](http://www.foodstandards.gov.au/foodstandardscode/index.cfm#_FSCchapter1)
of the [Food Standards
Code](http://www.foodstandards.gov.au/foodstandardscode/). A list of
currently approved biotech food products is contained in Appendix III of
this report.

Under the Standard, food or ingredients labeled genetically modified
contain new genetic material or protein as a result of the genetic
modification or have altered characteristics, e.g. changed nutritional
values, compared to the conventional food. Some flavorings may also be
derived from genetically modified organisms, but labeling is only
required if they are in a concentration of more than 1 gram per kilogram
(0.1%). Food additives and processing aids do not need to be labeled
unless the introduced genetic material is present in the final food.

Under the labeling standard, for packaged foods the words \'genetically
modified\' must be used in conjunction with the name of the food, or in
association with the specific ingredient within the ingredient list; and
for unpackaged foods for retail sale (such as unpackaged fruit and
vegetables, or unpackaged processed or semi-processed foods) the words
\'genetically modified\' must be displayed in association with the food,
or in association with the particular ingredient within that food.

## Biotech Feed Products

Animal feeds containing GMOs (e.g. whole grains or oilseeds) are
regulated by the OGTR. The OGTR considers any biosafety risks associated
with the product and, if necessary, will apply special conditions, or
may prohibit the use of the product as animal feed. As an example, after
a GMO has undergone field trials, the organization conducting the trials
may wish to use the unviable by-product (such as seed) as animal feed.
Before the product is used in any way, the Gene Technology Regulator
will consider any risks and, if necessary, will apply conditions or
disallow the product to be used.

The Australian Quarantine & Inspection Service (AQIS) and the OGTR must
approve genetically modified whole grain commodities (including
oilseeds) imported into Australia for animal feed (such as whole
soybeans and corn). The AQIS provides quarantine inspection and
certification for the arrival of imports of the products to ensure the
product is free of pest and disease and specific license conditions are
enforced to ensure the product meets requirements. The OGTR also
assesses the product, issues a license to the organization importing the
product, and may apply further conditions above those stipulated by
AQIS.

Large amounts of biotech feed products are used in Australia's intensive
livestock sector. A large proportion of Australia's soybean meal is
imported, including from the United States. All cottonseed meal used in
Australia is considered to be biotech as over 80 percent of the cotton
crop is planted to biotech varieties. Biotech and non-biotech cotton
varieties are not typically segregated in Australia.

It should be noted that some industries, in particular poultry and
dairy, have moved to source non-biotech products for their feed under
pressure from consumer and other interest groups.

Genetically modified animal feed does not require special labeling in
Australia.

## Coexistence Between Biotech & Non-Biotech Crops

Coexistence of biotech, conventional and organic crops has occurred in
Australia since biotech cotton varieties were commercially grown in
1996. As part of any license to grow a biotech crop, OGTR stipulates the
conditions under which the crop can be grown to ensure no
cross-contamination with conventional or organic crops in the vicinity.

In 2001, in recognition of the need to manage issues relating to the
coexistence of grain crops, in particular biotech canola, the grains
industry in Australia established the [Gene Technology Grains Committee
(GTGC)](http://www.avcare.org.au/default.asp?V_DOC_ID=887) to develop
and recommend to industry and government stakeholders, plans based on a
strategic framework for enabling the coexistence of different production
systems and supply chains. The committee was made up of representatives
from across the grains industry, including seed producers, growers, bulk
handlers, marketers and food producers.

The framework entitled, "A strategic framework for maintaining
coexistence of supply chains" was released in December 2002, providing a
basis for growers to deliver biotech or non-biotech grain (and oilseed)
crops into the marketplace. Following feedback on the framework, the
GTGC then developed a specific canola management plan, The Canola
Industry Stewardship Principles (released in July 2003), in preparation
for the commercial release of biotech canola.

To date, the Principles have not been able to be assessed due to state
and territory governments (apart from the Northern Territory and
Queensland) implementing moratoriums on the commercial production of
biotech food crops.

## Biosafety Protocol

Australia has not signed or ratified the Biosafety Protocol and the
Australian Government has no timetable for consideration of accession to
the Protocol. This is due to concerns about how the Protocol will
operate in practice (documentation requirements, and the liability and
compliance arrangements are yet to be agreed), uncertainty about how
parties will implement the Protocol and whether they will do so in a way
which respects all of their international obligations, and uncertainty
about any individual country's capacity to influence decision-making.
Moreover, the government considers that the Protocol is not needed for
Australia to manage biotech imports as Australia already has a robust
regulatory framework through the Office of Gene Technology Regulator.

# Section IV: Marketing

## Market Acceptance

Australia has a substantial, risk assessment based regulatory framework
for dealings with gene technology and genetically modified organisms and
the Government is supportive of the technology. Australia's
biotechnology sector is small in global terms, but growing, with an
estimated 370 biotechnology companies in 2004.

Most Australian states and territories (using their powers over
commodity 'marketing') have moved to restrict or ban the commercial
planting of biotech crops in their jurisdictions. Biotech canola, which
OGTR approved for commercial release in 2003, has been the driving force
behind most of these restrictions. Major Australian commodity groups
have voiced concerns about introducing biotech canola and have advocated
for a 'go-slow' approach, largely because of the potential impact
biotech canola could have on their domestic and export businesses.

The Australian cotton crop is over 80 percent biotech, and there has
been little controversy concerning its cultivation. Indeed,
environmental benefits and the significant decline in pesticide and
herbicide use for this crop have been widely reported. Biotech
cottonseed does appear in the domestic market through the oil and meal,
and this has not met with any major opposition.

The experience with biotech canola, however, would seem to indicate that
it could be some time before Australia has large-scale commercial
plantings of biotech food crops, even when varieties have met the
approval of OGTR. OGTR is currently assessing applications for field
trials for biotech wheat, while field trials of other biotech wheat
varieties were conducted dating back to 1996. Presently, however, there
is significant resistance to any commercial growing of biotech wheat.
AWB Limited, the monopoly wheat exporter, has expressed concern about
biotech wheat's potential impact on its existing export markets and
argues that commercial releases shouldn't go forward until market
preferences change and/or the supply chain can guarantee segregation.
This commercial resistance and the restrictions in place in the states
and territories will make the introduction of biotech wheat problematic.

Private voluntary groups have been active in Australia in attempting to
pressure producers, food processors and retailers to stop using biotech
products in their businesses. These efforts have been widely reported,
but their effectiveness has been relatively limited. A recent survey
found that Australians are more likely to be concerned about pollution,
greenhouse effects and nuclear waste than any risk in the use of gene
technology.

### National Biotechnology Strategy

The Australian Federal Government launched the [National Biotechnology
Strategy](http://www.biotechnology.gov.au/index.cfm?event=object.showContent&objectID=538B635B-BCD6-81AC-1E1B66BB24EA3184)
(NBS) in July 2000 with A\$30.5 million over three years (FY 2001--04)
for targeted initiatives to support the Government's vision for
biotechnology. The Strategy was boosted in January 2001 by a further
A\$66.5m from the Innovation Statement, Backing Australia's Ability,
with funding for the Biotechnology Center of Excellence and additional
funding for the Biotechnology Innovation Fund. Biotechnology also
receives funding through other programs in the health, agriculture,
environment and education portfolios. In addition to the Commonwealth
Government's contribution to biotechnology development, Australia's
State and Territory governments also commit resources to the development
of biotechnology.

The key objective of the Strategy is to provide a framework for
Government and key stakeholders to work together to ensure that
developments in biotechnology are captured for the benefit of the
Australian community, industry and the environment, while safeguarding
human health and ensuring environmental protection. The Strategy
addresses six key themes with specific objectives and strategies to
achieve them:

-   Biotechnology in the community

-   Ensuring effective regulation

-   Biotechnology in the economy

-   Australian biotechnology in the global market

-   Resources for biotechnology; and

-   Maintaining momentum and coordination.

### Biotechnology Australia

[Biotechnology Australia](http://www.biotechnology.gov.au/) (BA) is
located within the Department of Industry, Tourism and Resources and
ensures that the key elements of the National Biotechnology Strategy are
implemented. BA coordinates the non-regulatory biotechnology activities
of the Australian Government. It has five formal partners - the
Department of Industry, Tourism and Resources, the Department of
Agriculture, Fisheries and Forestry, Department of Health and Ageing,
Department of Environment and Heritage, and Department of Education,
Science and Training. BA also works with the states and territories to
strengthen national efforts on biotechnology through the Biotechnology
Liaison Committee.

An evaluation in 2003 of the first three years of the NBS found that the
NBS has made significant progress in meeting the Government's
objectives, but that challenges remain. To continue to address these
challenges, BA received funding of A\$20m for the next four years under
the Backing Australia\'s Ability - Building our Future through Science
and Innovation initiatives announced in May 2004.

Targets for 2004--05 are:

-   Further strengthen the national approach on biotechnology with the
    states, territories, industry and other sector representatives

-   Increase public awareness activities aimed at providing factual and
    balanced information on biotechnology to the Australian community

-   Coordinate Government activities and support for the Biotechnology
    Ministerial Council, the Australian Biotechnology Advisory Council
    and the Biotechnology Liaison Committee

-   Complete studies and initiatives in agricultural biotechnology where
    information gaps exist, focusing on supply chain management,
    marketing, and emerging issues

-   Undertake studies supporting the role of the Minister for the
    Environment and Heritage in providing advice to the Gene Technology
    Regulator under the Gene Technology Act 2000, and implementing a
    nationally consistent approach to access and use of genetic
    resources

### National Farmers Federation

In March 2003, the National Farmers Federation released a [Biotechnology
Position
Statement](http://www.nff.com.au/pages/sub/biotechnology_position.pdf)
recognizing the potential of biotechnology as a valuable tool within
agricultural production systems and urging that all potential benefits
should be available to farmers to make informed choice in their farming
decisions.

## Country Specific Studies Relevant to U.S. Exporters

The **Department of Agriculture, Fisheries & Forestry** has a number of
publications available on the [Agriculture & Food Biotechnology
page](http://www.affa.gov.au/content/output.cfm?ObjectID=5A53B336-FC4E-411E-8C06A9D82C6AE0C9).

[**Agrifood Awareness Australia**](http://www.afaa.com.au/) -- This
organization publishes a large number of bulletins and information
guides.

**Rural Industries Research & Development Corporation**
([RIRDC](http://www.rirdc.gov.au/)) has recently published the following
studies:

[Impact of Genetic Engineering on Consumer Demand, February
2005](http://www.rirdc.gov.au/reports/GLC/05-015.pdf)

[Global Response to GM Food Technology: Implications for Australia,
February 2005](http://www.rirdc.gov.au/reports/GLC/05-016.pdf)

**Biotechnology Australia** also has a number of [papers &
reports](http://www.biotechnology.gov.au/content/controlfiles/display_details.cfm?ObjectID=2205A44A-D36F-4CB5-AE183BCB5DC30A18)
available on their website.

# Section V: Reference Material

Below are links to various organizations involved in the agricultural
biotechnology sector in Australia.

[Australian Government]{.underline}

[Office of the Gene Technology Regulator](http://www.ogtr.gov.au/)

[Biotechnology Australia](http://www.biotechnology.gov.au/)

[Food Standards Australia New Zealand](http://www.foodstandards.gov.au/)

[Australian Pesticides & Veterinary Medicines
Authority](http://www.apvma.gov.au/)

[Therapeutic Goods Administration](http://www.tga.gov.au/gene/index.htm)

[Department of Agriculture, Fisheries &
Forestry](http://www.affa.gov.au/content/output.cfm?ObjectID=5A53B336-FC4E-411E-8C06A9D82C6AE0C9)

[Other Organizations]{.underline}

[Agrifood Awareness Australia](http://www.afaa.com.au/)

[National Farmers Federation](http://www.nff.org.au/)

# Appendix I: GMO Applications Under Evaluation

The Office of the Gene Technology Register has received the following
applications for evaluation. All applications are posted on the OGTR
website when they are first received and again when public comment is
sought. Full details of all applications can be found at:
[www.ogtr.gov.au/ir/index.htm](http://www.ogtr.gov.au/ir/index.htm).

  -----------------------------------------------------------------------------
  **Crop**     **Trait Category**           **Applicant**   **Status**
  ------------ ---------------------------- --------------- -------------------
  Indian       Field trial of herbicide     Bayer Crop      Application
  Mustard      tolerant Indian Mustard      Sciences        notified December
               (Brassica juncea)                            2004.

  Cotton       Commercial release of        Bayer Crop      Application
               herbicide tolerant cotton    Science         notified November
               (LLCotton25)                                 2004. Application
                                                            'clock' stopped
                                                            pending provision
                                                            of additional
                                                            information

  Cotton       Field trials of herbicide    Monsanto        Application
               tolerant (Roundup Ready®     Australia Ltd   notified November
               Flex MON 88913) and                          2004. Call for
               herbicide tolerant/insect                    public comment
               resistant (Roundup Ready®                    opened February
               Flex Mon 88913/Bollgard II®)                 2005
               cottons                                      

  Wheat        Field trial of genetically   CSIRO           Application
               modified wheat with altered                  notified September
               grain starch                                 2004. Call for
                                                            public comments
                                                            opened January
                                                            2005.

  Wheat        Field trial of genetically   Grain Biotech   Application
               modified salt tolerant wheat Australia       notified September
               on saline land                               2004. Call for
                                                            public comment
                                                            opened March 2005

  Cattle       Trial vaccination of cattle  Queensland      Application
  Vaccine      with recombinant *Bovine     Department of   notified June 2004.
               herpesvirus* vaccines        Primary         Call for public
                                            Industries &    comment opened
                                            Fisheries       March 2005

  Poultry      Development of Fowl          Imugene Limited Application
  Vaccine      Adenovirus (FAV) Vaccine                     notified December
               Vectors containing the                       2003. Application
               chicken interferon gamma                     'clock' stopped
               gene.                                        pending provision
                                                            of additional
                                                            information.

  Pork Vaccine Development of Porcine       Imugene Limited Application
               Adenovirus (PAV) Vaccine                     notified December
               Vectors containing pig genes                 2003. Application
               for immuno-regulatory                        'clock' stopped
               molecules (either interferon                 pending provision
               gamma or interleukin 5)                      of additional
                                                            information.
  -----------------------------------------------------------------------------

# Appendix II: GMOs Already Licensed for Use in Australia

The following biotech crops have been granted licenses by OGTR for
various uses. Full details are available on the OGTR website at:
[www.ogtr.gov.au/gmorec/ir.htm](http://www.ogtr.gov.au/gmorec/ir.htm).

  ------------------------------------------------------------------------------------------
  **Crop**              **Trait          **Applicant**   **License Purpose**  **Status**
                        Category**                                            
  --------------------- ---------------- --------------- -------------------- --------------
  Cultivated rice/Oryza Herbicide        CSIRO           Field trial of       Current
  sativa L. cv          tolerance,                       genetically modified 
  Nipponbare            antibiotic                       rice (*Oryza sativa* 
                        resistance and                   L.) functional       
                        reporter genes                   characterizations of 
                        have been                        the rice genome      
                        randomly                                              
                        inserted into                                         
                        rice plants.                                          
                        Some plant                                            
                        growth traits                                         
                        may be modified                                       
                        by gene                                               
                        knockouts.                                            

  Sugarcane/Saccharum   Altered sugar    The University  Field trial of       Current
  officinarum L. x S.   production and   of Queensland   genetically modified 
  spontaneum L.         Antibiotic                       sugarcane expressing 
                        resistance                       sucrose isomerase    

  Cotton/Gossypium      One reporter     CSIRO           Cotton Field Trial - Current
  hirsutum L            gene (enables                    Evaluation under     
                        detection and                    field conditions of  
                        quantification                   the cotton rubisco   
                        of gene                          small subunit        
                        expression)                      promoter driving a   
                        linked to one of                 reporter gene        
                        two promoters,                                        
                        and either one                                        
                        or two                                                
                        selectable                                            
                        marker genes                                          
                        (antibiotic                                           
                        resistance)                                           

  Cotton/Gossypium      Insecticidal     Hexima Limited  Field trial to       Current
  hirsutum L            action,          Ltd             assess transgenic    
                        antibiotic                       cotton expressing    
                        resistance                       natural plant genes  
                                                         for insect control   

  White                 Viral Disease    Department of   Field Evaluation of  Current
  Clover/Trifolium      Resistance,      Primary         Genetically Modified 
  repens L              Antibiotic       Industries      White Clover         
                        resistance       (Victoria)      Resistant to         
                                                         Infection by Alfalfa 
                                                         Mosaic Virus         

  Cotton/Gossypium      Insecticidal and Dow             Agronomic assessment Current
  hirsutum L            herbicide        AgroSciences    and seed increase of 
                        tolerance        Australia Pty   transgenic cottons   
                                         Ltd             expressing           
                                                         insecticidal genes   
                                                         (cry1Ac and cry1Fa)  
                                                         from Bacillus        
                                                         thuringiensis        

  Cotton/Gossypium      Insect           Dow             Agronomic assessment Current
  hirsutum              resistance,      AgroSciences    and seed increase of 
                        herbicide        Australia Pty   transgenic cotton    
                        tolerance        Ltd             expressing insect    
                                                         tolerance genes from 
                                                         Bacillus             
                                                         thuringiensis        

  Cotton/Gossypium      Modified fatty   CSIRO           Field Evaluation of  Current
  hirsutum              acid content in                  Genetically Modified 
                        cottonseed oil                   High Oleic (HO)      
                                                         Cotton               

  Cotton/Gossypium      Herbicide        CSIRO           Field trial for      Current
  hirsutum              tolerance                        breeding and         
                                                         pre-commercial       
                                                         evaluation of cotton 
                                                         expressing tolerance 
                                                         to the herbicide     
                                                         glufosinate ammonium 

  Cotton/Gossypium      Insect           CSIRO           Breeding and         Current
  hirsutum              resistance,                      pre-commercial       
                        herbicide                        evaluation of        
                        tolerance,                       transgenic cotton    
                        antibiotic                       expressing a         
                        resistance                       vegetative           
                                                         insecticidal protein 
                                                         *(VIP)* gene and a   
                                                         herbicide tolerance  
                                                         gene                 

  Cotton/Gossypium      Enhanced         Monsanto        Field trials of      Current
  hirsutum              herbicide        Australia Ltd   herbicide tolerant   
                        tolerance,                       (Roundup Ready® MON  
                        insect                           88913) and herbicide 
                        resistance,                      tolerant/insect      
                        antibiotic                       resistant (Roundup   
                        resistance,                      Ready® MON           
                        reporter gene                    88913/Bollgard II®)  
                        expression                       cotton               

  Cotton/Gossypium      Insect           Syngenta Seeds  The evaluation of    Current
  hirsutum              resistance,      Pty Ltd         Transgenic Cotton    
                        antibiotic                       Plants Expressing    
                        resistance                       the VIP Gene         

  Cholera               Attenuation by   CSL Ltd         Commercial release   Current
  vaccine/Vibrio        removal of                       of recombinant live  
  cholerae.             cholera toxin                    oral cholera vaccine 
                        subunit A and                    (Orochol® vaccine)   
                        inclusion of a                                        
                        mercury                                               
                        resistance                                            
                        marker                                                

  Canola/Brassica napus Herbicide        Bayer           Field Trial - Seed   Current
                        tolerant hybrid  CropScience Pty increase and field   
                        canola           Ltd             evaluation of        
                                                         herbicide tolerant   
                                                         hybrid canola        

  Grapevines/Vitis      Expression of    CSIRO           Field trial of       Current
  vinifera L.           modified colour,                 grapevines -         
                        sugar                            evaluation of berry  
                        composition,                     color, sugar         
                        flowering and                    composition, flower  
                        fruit                            and fruit            
                        development,                     development and gene 
                        expression of                    flow study           
                        green                                                 
                        fluorescence                                          
                        protein,                                              
                        antibiotic                                            
                        resistance                                            

  Carnation/Dianthus    Modified flower  Florigene Ltd   Ongoing commercial   Current
  caryophyllus          color                            release of color     
                                                         modified carnations  

  Pineapple/Ananas      Reduction of     Department of   Field trial of       Current
  comosus               blackheart,      Primary         pineapple plants     
                        delayed          Industries      modified for         
                        flowering,                       blackheart reduction 
                        reporter gene                    and to delay         
                        expression,                      flowering            
                        antibiotic                                            
                        resistance                                            

  Pineapple/Ananas      Delayed          The University  Field trial of       Current
  comosus               flowering,       of Queensland   pineapple plants     
                        herbicide                        modified to control  
                        resistance,                      flowering            
                        reporter gene                                         
                        expression                                            

  Papaya/Carica papaya  Delayed fruit    The University  Field trial for      Current
                        ripening,        of Queensland   evaluation of papaya 
                        reporter gene                    to delay fruit       
                        expression and                   ripening and to test 
                        antibiotic                       the expression of    
                        resistance                       the introduced genes 

  Cotton/Gossypium      Herbicide        Monsanto        Commercial release   Current
  hirsutum              tolerant,        Australia Ltd   of herbicide         
                        insecticidal                     tolerant (Roundup    
                        cotton                           Ready®) and          
                                                         herbicide            
                                                         tolerant/insect      
                                                         resistant (Roundup   
                                                         Ready®/INGARD®)      
                                                         cotton               

  Cotton/Gossypium      Insecticidal     Monsanto        Commercial release   Current
  hirsutum              cotton           Australia Ltd   of insecticidal      
                                                         (INGARD®) cotton     

  Canola/Brassica napus Herbicide        Bayer           Commercial release   Current
                        tolerance,       CropScience Pty of InVigor® hybrid   
                        Hybrid Breeding  Ltd             canola (Brassica     
                        System                           napus) for use in    
                                                         the Australian       
                                                         cropping system      

  Canola/Brassica napus Herbicide        Monsanto        General release of   Current
                        tolerance        Australia Ltd   Roundup Ready®       
                                                         canola (Brassica     
                                                         napus) in Australia  

  Sugarcane/Saccharum   Green            Bureau of Sugar Agronomic assessment Current
  interspecific hybrid  fluorescent      Experiment      of transgenic        
                        reporter gene    Stations        sugarcane engineered 
                                                         with reporter genes  

  Poppy/Papaver         Altered alkaloid CSIRO           Field trial of       Post harvest
  somniferum            production                       oilseed poppy in     monitoring
                        pathway                          Tasmania to evaluate 
                                                         alkaloid production  

  Cotton/Gossypium      Insect           CSIRO           Field trials of      Post harvest
  hirsutum              resistance                       insect resistant     monitoring
                                                         cotton               

  Cotton/Gossypium      Insect           Monsanto        Commercial release   Current/Post
  hirsutum              resistance and   Australia Ltd   of BollgardII and    harvest
                        herbicide                        BollgardII/Roundup   monitoring
                        tolerance                        Ready® cotton        

  Canola/Brassica napus Hybrid breeding  Aventis         Small and large      Current/Post
                        system and       CropScience Pty scale trialing of    harvest
                        herbicide        Ltd             InVigor® canola      monitoring
                        tolerance                        (*Brassica napus*)   
                                                         for development for  
                                                         the Australian       
                                                         cropping system      

  Cotton/Gossypium      Insect           Department of   Preliminary field    Post harvest
  hirsutum              resistance       Agriculture     evaluation of        monitoring
                                         (WA)            Bollgard II® cotton  
                                                         in the Kimberley     
                                                         region of WA         

  Cotton/Gossypium      Insect           Department of   Integrated pest      Post harvest
  hirsutum              resistance       Agriculture     management systems   monitoring
                                         (WA)            for INGARD® cotton   
  ------------------------------------------------------------------------------------------

# Appendix III: Approved GM Food Products

The following table contains a current list of approved biotech food
products. Detailed information is contained in [Standard
1.5.2](http://www.foodstandards.gov.au/foodstandardscode/index.cfm#_FSCchapter1)
on the FSANZ web site.

  -----------------------------------------------------------------------
  Food produced using gene technology         Special conditions
  ------------------------------------------- ---------------------------
  Food derived from glufosinate               
  ammonium-tolerant corn line T25             

  Food derived from glufosinate ammonium      
  tolerant soybean lines A2704-12 and         
  A5547-127                                   

  Food derived from glyphosate-tolerant corn  
  line GA21                                   

  Food derived from glyphosate-tolerant corn  
  line NK603                                  

  Food derived from glyphosate-tolerant       
  soybean line 40-3-2                         

  Food derived from glyphosate-tolerant       
  sugarbeet line 77                           

  Food derived from high oleic acid soybean   The label on or attached to
  lines G94-1, G94-19 and G168                a package of a food derived
                                              from high oleic acid soy
                                              bean lines G94-1, G94-19
                                              and G168 must include a
                                              statement to the effect
                                              that the food has been
                                              genetically modified to
                                              contain high levels of
                                              oleic acid

  Food derived from insect- and potato        
  leafroll virus-protected potato lines       
  RBMT21-129, RBMT21-350, and RBMT22-82.      

  Food derived from insect- and potato virus  
  Y-protected potato lines RBMT15-101,        
  SEM15-02 and SEM15-15.                      

  Food derived from insect-protected and      
  glufosinate-ammonium tolerant corn line     
  1507                                        

  Food derived from insect-protected and      
  glufosinate ammonium-tolerant DBT418 corn   

  Food derived from insect-protected Bt-176   
  corn.                                       

  Food derived from insect-protected corn     
  event MON863                                

  Food derived from insect-protected corn     
  line MON 810                                

  Food derived from insect-protected,         
  glufosinate ammonium-tolerant Bt-11 corn.   

  Food derived from insect-protected potato   
  lines BT-06, ATBT04-06, ATBT04-31,          
  ATBT04-36, and SPBT02-05                    

  Oil and linters derived from                
  bromoxynil-tolerant cotton containing       
  transformation events 10211 and 10222       

  Oil and linters derived from                
  glyphosate-tolerant cotton line 1445        

  Oil and linters derived from                
  insect-protected cotton line COT102         

  Oil and linters derived from                
  insect-protected cotton lines containing    
  event 15985                                 

  Oil and linters derived from                
  insect-protected cotton lines 531, 757 and  
  1076                                        

  Oil derived from bromoxynil-tolerant canola 
  line Westar-Oxy-235                         

  Oil derived from glufosinate-ammonium       
  tolerant canola lines Topas 19/2 and T45    
  and glufosinate-ammonium tolerant and       
  pollination controlled canola lines Ms1,    
  Ms8, Rf1, Rf2 and Rf3                       

  Oil derived from glyphosate-tolerant canola 
  line GT73                                   
  -----------------------------------------------------------------------