Download Application No. DIR 108 SUMMARY INFORMATION

April1 2011
APPLICATION FOR LICENCE FOR INTENTIONAL RELEASE OF GMOs INTO THE
ENVIRONMENT: Application No. DIR 108
SUMMARY INFORMATION
Project Title:
Commercial release of canola genetically modified for herbicide tolerance
and a hybrid breeding system (GM InVigor® x Roundup Ready® canola)2
Applicant:
Bayer CropScience Pty Ltd (Bayer)
Common name of the
parent organism:
Canola
Scientific name of the
parent organism:
Brassica napus (L.) ssp. oleifera
Modified trait(s):
Herbicide tolerance, a hybrid breeding system and antibiotic resistance
Identity of the gene(s)
responsible for the
modified trait(s):

Glyphosate herbicide tolerance conferred by the cp4 epsps gene
obtained from the bacterium Agrobacterium sp. strain CP4 and the
goxv247 gene obtained from the bacterium Ochrobactrum anthropi
strain LBAA

Glufosinate-ammonium herbicide tolerance conferred by the bar gene
obtained from the bacterium Streptomyces hygroscopicus and/or the pat
gene obtained from the bacterium Streptomyces viridichromogenes

A hybrid breeding system consisting of the barnase (male sterility) and
barstar (fertility restorer) genes derived from the bacterium
Bacillus amyloliquefaciens

Antibiotic resistance conferred by the nptII gene derived from the
bacterium Escherichia coli
Proposed Location(s):
All commercial canola growing areas of Australia
Proposed Release Size:
N/A
Proposed Release Dates:
Ongoing from date of approval
Introduction
The Gene Technology Act 2000 (the Act) in conjunction with the Gene Technology Regulations
2001, an inter-governmental agreement and corresponding legislation that is being enacted in
each State and Territory, comprise Australia’s nationally consistent regulatory system for gene
technology. Its objective is to protect the health and safety of people, and the environment, by
identifying risks posed by or as a result of gene technology, and managing those risks by
regulating certain dealings with genetically modified organisms (GMOs).
The Act establishes a statutory officer, the Gene Technology Regulator (the Regulator), to
administer and make decisions under the legislation. The Regulator is supported by the Office of
1
This Application summary has been updated to clarify the GM canola lines approved under licence DIR 021/2002
and proposed for this application.
2
The title of the licence application submitted by Bayer is ‘Commercial release of InVigor x Roundup Ready canola
(Brassica napus) for use in the Australian cropping system’.
the Gene Technology Regulator (OGTR), an Australian Government regulatory agency located
within the Health and Ageing portfolio.
The legislation sets out requirements for considering applications for licences for dealings with
GMOs, including matters that the Regulator must take into account before deciding whether or
not to issue a licence. The Regulator’s Risk Analysis Framework3 outlines the assessment process
that will be followed.
The application and the proposed dealings
The Regulator has received an application from Bayer seeking approval for the commercial
release of genetically modified (GM) canola into the Australian environment. The GM canola
proposed for release is known as InVigor® x Roundup Ready® canola.
GM InVigor® x Roundup Ready® canola was produced by conventional breeding between GM
InVigor® canola and GM Roundup Ready® canola, which were individually approved by the
Regulator in 2003 for commercial release under licences DIR 021/2002 and DIR 020/2002,
respectively.
Seven elite lines4 (T45, Topas 19/2, MS1, MS8, RF1, RF2 and RF3) were authorised for release
under licence DIR 021/2002. All seven GM canola lines contain a gene conferring tolerance to
the herbicide glufosinate-ammonium. In addition, MS1, MS8, RF1, RF2 and RF3 contain genes
comprising a hybrid breeding system, and Topas 19/2, MS1, RF1 and RF2 contain an antibiotic
resistance gene. The InVigor® hybrid canola released commercially was derived from a cross
between the MS8 and RF3 lines. The other approved lines were not grown commercially. GM
Roundup Ready® canola is represented by a single elite line known as GT73. This line contains
two genes that confer tolerance to the herbicide glyphosate.
The GM InVigor® x Roundup Ready® canola line that Bayer intends to commercialise in
Australia will be derived from a cross between the GM InVigor® hybrid MS8 x RF3 and GM
Roundup Ready® elite line GT73. As such, this line will contain four genes conferring tolerance
to glufosinate-ammonium and glyphosate herbicides and two genes that comprise a hybrid
breeding system. However, Bayer is seeking approval from the Regulator to release GM canola
derived from conventional breeding between GM Roundup Ready® elite line GT73 and all GM
canola lines authorised for release under licence DIR 021/2002.
The applicant proposes the release to occur in all commercial canola growing areas of Australia.
GM canola and GM canola-derived products from GM InVigor® x Roundup Ready® canola
would enter general commerce, including use in human food and animal feed. Food Standards
Australia New Zealand (FSANZ) has approved the use of food derived from GM InVigor®
canola and GM Roundup Ready® canola for human consumption. These approvals also cover
GM InVigor® x Roundup Ready® canola.
Parent organism
The parent organism, Brassica napus (L.) ssp. oleifera, is commonly known as canola. Canola is
exotic to Australia but is grown commercially in large areas of New South Wales, Victoria, South
3
The Risk Analysis Framework and further information on the assessment of licence applications is available from
the Office of the Gene Technology Regulator (OGTR). Free call 1800 181 030 or at <http://www.ogtr.gov.au>.
4
The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification(s)
resulting from a single transformation event.
2
Australia and Western Australia. Small areas of production also exist in Tasmania and
Queensland.
The genetic modifications and their effect
All GM InVigor® x Roundup Ready® canola lines proposed for commercial release contain
genes conferring tolerance to the herbicides glufosinate-ammonium and glyphosate. In addition,
some GM InVigor® x Roundup Ready® lines may contain genes conferring a hybrid breeding
system and/or an antibiotic resistance gene, depending on the specific GM InVigor® parent line.
Glyphosate tolerance is conferred by expression of the goxv247 gene (a modified version of the
gox gene obtained from the soil bacterium Ochrobactrum anthropi strain LBAA) and the cp4
epsps gene obtained from the soil bacterium Agrobacterium tumefaciens strain CP4. The gox
gene encodes glyphosate oxidoreductase, an enzyme capable of degrading glyphosate into nontoxic metabolites. The cp4 epsps gene encodes a 5-enolpyruvylshikimate-3-phosphate synthase
(EPSPS) enzyme. EPSPS enzymes participate in a biosynthetic pathway found in both plants and
microorganisms that is required for the synthesis of some essential amino acids. Most plant
EPSPS enzymes are inhibited by glyphosate, which results in plant death due to the lack of
essential amino acids. However, CP4 EPSPS has a much lower affinity for glyphosate than
related plant EPSPS enzymes and can continue to function in the presence of glyphosate.
Glufosinate-ammonium herbicide tolerance may be provided by expression of the pat gene
obtained from Streptomyces viridochromogenes and/or the bar gene obtained from S.
hygroscopicus. Both genes encode functionally equivalent phosphinothricin acetyltransferase
enzymes that alter the structure of the active component in glufosinate-ammonium herbicides,
rendering the herbicide inactive.
Some GM InVigor® x Roundup Ready® canola lines may contain the barnase and/or barstar
genes obtained from the soil bacterium Bacillus amyloliquefaciens. Barnase encodes a
ribonuclease enzyme called barnase, and barstar encodes a specific inhibitor of the barnase
enzyme. Barnase is produced specifically in the male parts of GM flowers and prevents pollen
production, resulting in male-sterility. Production of barstar in GM plants inhibits barnase activity
to restore fertility of the flower.
Some GM InVigor® x Roundup Ready® canola lines also contain the nptII gene obtained from
the bacterium, Escherichia coli. The nptII gene encodes the enzyme neomycin
phosphotransferase II which confers resistance to kanamycin and structurally related antibiotics.
It has been used extensively as a selectable marker in the production of GM plants worldwide.
Short regulatory sequences necessary to control expression of the novel genes are present in GM
InVigor® x Roundup Ready® canola. These sequences have been derived from: the common soil
bacterium Agrobacterium tumefaciens; the plant species Arabidopsis thaliana (thale cress),
Nicotiana tabacum (tobacco) and Pisum sativum (pea); and the plant viral pathogens Cauliflower
mosaic virus and Figwort Mosaic Virus.
Method of genetic modification
The novel genes in GM InVigor® and GM Roundup Ready® canola were introduced into
conventional canola on plasmid vectors carried by Agrobacterium tumefaciens. This method has
been widely used in Australia and overseas for introducing new genes into plants. GM InVigor®
x Roundup Ready® canola was produced by conventional breeding between GM InVigor®
canola and GM Roundup Ready® canola.
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Previous releases of the same or similar GMOs
Field trials of GM InVigor® canola began in Australia in 1996. The first field trials were
overseen by the Genetic Manipulation Advisory Committee (GMAC) as Planned Releases (PR)
PR-62, PR-63 and their respective extensions. Under the current regulatory system, trials were
subsequently approved by the Regulator under licence DIR 010/2001. Commercial release of GM
InVigor® canola was approved by the Regulator in 2003 under licence DIR 021/2002. As yet,
GM InVigor® canola has not been commercially grown in Australia. However, it has been grown
commercially in North America since 1995.
Field trials of GM Roundup Ready® canola began in Australia in 1997. The trials were overseen
by GMAC as PR-77 and associated extensions and were approved by the Regulator under licence
DIR 011/2001. Commercial release of GM Roundup Ready® canola was approved by the
Regulator in 2003 under licence DIR 020/2002. Commercial production began in New South
Wales and Victoria in 2008 and in Western Australia in 2010. GM Roundup Ready® canola has
also been grown commercially in North America since 1996.
GM InVigor® x Roundup Ready® canola has been approved by the Regulator for limited and
controlled release (field trials) under licences DIR 069/2006 and DIR 104.
State and Territory GM crop legislation
Cultivation of GM canola may also be subject to additional restrictions in some Australian States
and Territories. The Act allows for areas to be designated under State and Territory law for the
purpose of preserving the identity of non-GM or GM crops for marketing purposes. Following
the Regulator’s approval in 2003 of GM InVigor® canola and GM Roundup Ready® canola on
human health and environmental safety grounds, all jurisdictions except Queensland and the
Northern Territory enacted legislation to delay the commercial release of GM crops, including
GM canola, until marketability, agricultural trade and segregation issues were better understood.
Subsequently, GM canola approved by the Regulator has been allowed to be commercially
cultivated in New South Wales, Victoria and Western Australia. Further information about the
State and Territory GM crop legislation applying to GM canola can be found in the Fact Sheet
Status of GM canola approvals5 prepared by the OGTR.
Suitability of Applicant
Section 43(2)(f) of the Act requires the Regulator to be satisfied regarding the suitability of the
applicant to hold a licence as a pre-requisite for considering DIR applications. The matters to be
considered are outlined in section 58 of the Act and include capacity to meet the conditions of a
licence, relevant convictions and any revocation of a licence or permit held under law relating to
the health and safety of people or the environment.
The Regulator has determined that Bayer currently meets the suitability requirements and will
verify this continues to be the case prior to making any decision regarding the issuing of a
licence.
Consultation process for this DIR application
Since this application is for commercial purposes, it cannot be considered a limited and
controlled release application under section 50A of the Act.
5
The Fact Sheet Status of GM canola approvals is available from the Office of the Gene Technology Regulator
(OGTR). Free call 1800 181 030 or at <http://www.ogtr.gov.au>.
4
This means that the Regulator is required to seek advice from prescribed experts, agencies and
authorities on matters relevant to the preparation of a Risk Assessment and Risk Management
Plan (RARMP), in accordance with section 50 of the Act. This first round of consultation must
include the Gene Technology Technical Advisory Committee, State and Territory Governments,
Australian Government agencies, any local council that the Regulator considers appropriate and
the Environment Minister. While the Regulator is not required to seek public comment at this
stage, copies of the application are available on request from the OGTR.
In a second round of consultation, the Regulator will seek comment on the consultation RARMP
from the public as well as prescribed experts, agencies and authorities. The RARMP will then be
finalised, taking into account matters raised relating to risks to human health and safety and the
environment, and form the basis of his decision whether or not to issue a licence.
At this stage, the consultation RARMP is expected to be released for comment in August 2011.
The public will be invited to provide submissions on the RARMP via advertisements in the media
and direct mail to anyone registered on the OGTR mailing list. The RARMP and other related
documents will be available on the OGTR website, or in hard copy from the OGTR.
If you have any questions about the application or the assessment process, or wish to register on
the mailing list, please contact the OGTR at:
The Office of the Gene Technology Regulator, MDP 54 GPO Box 9848 Canberra ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: [email protected]
Website http://www.ogtr.gov.au
5