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27 March 2017
Summary of Licence Application DIR 154
Introduction
An application has been made under the Gene Technology Act 2000 (the Act) for Dealings involving the
Intentional Release (DIR) of genetically modified organisms (GMOs) into the Australian environment, on
a limited scale under controlled conditions.
Application number
DIR 154
Applicant:
Bioproperties Pty Ltd
Project Title:
Limited and controlled release of a GM vaccine for Chickens, Vaxsafe®
ILT 1
Parent organism:
Infectious laryngotracheitis virus (ILTV)
Modified genes:
Deletion of gene encoding glycoprotein G protein from the ILTV
genome
Proposed release date: Once all the required approvals have been granted
Proposed duration:
5 years
Proposed locations:
Selected chicken farms in rural Victoria and New South Wales
Primary purpose:
To study the efficacy and safety of a GM vaccine against infectious
laryngotracheitis disease in farmed broiler chickens.
The proposed dealings
The applicant proposes to conduct field trials using a live attenuated genetically modified (GM) infectious
laryngotracheitis virus (ILTV) vaccine (known as Vaxsafe® ILT) to vaccinate broiler chickens against
infectious laryngotracheitis disease. The aim is to assess the efficacy and safety of the ILTV vaccine and
its biological characteristics. The vaccine will be administered to chickens by eye drop or mixed in the
chickens’ drinking water, following directions for use approved by the Australian Pesticides and
Veterinary Medicines Authority (APVMA).
Proposed limits and controls
The applicant proposes to conduct the field trials in selected commercial broiler chicken farms, including
free range chicken farms, in rural Victoria and New South Wales, over a five year period.
The applicant proposes a number of control measures to restrict the spread and persistence of the GMO
and its genetic material, each of which will be considered in the evaluation of this application. These
include:
•
requiring that the GMO be administered by appropriately trained farm personnel including farm
manager in accordance with trial protocols under the supervision of a registered veterinarian
•
following biosecurity measures for poultry production, including:
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The title of the project as supplied by the applicant is “A Field Trial Study of the Safety and Efficacy of Vaxsafe ILT
(BIOPROPERTIES Pty Ltd) against Infectious Laryngotracheitis in Chickens”.
Address: MDP 54 GPO Box 9848 Canberra ACT 2601
Telephone: 1800 181 030 E-mail: [email protected]
Office of the Gene Technology Regulator
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selection of sheds and other production areas physically isolated from other poultry
−
wearing overalls and high rubber boots when entering the sheds via an anteroom
−
implementing shed entry and exit procedures such as use of hand sanitizers and disinfectant
footbaths
•
only permitting trained and authorised workers to access trial sites
•
controlling pests and other animals such as wild birds, rodents and insects
•
disposing of dead vaccinated birds and litter following state and/or local council requirements
•
decontaminating sheds, water tanks, equipment and vehicles after removal of each vaccinated flock
•
decontamination of discarded vial containers and contaminated materials using effective
disinfectant.
Other regulatory approvals
The Australian Pesticides and Veterinary Medicines Authority (APVMA) administers the Agricultural and
Veterinary Chemicals Code Act 1994 (the Agvet Code) to regulate agricultural and veterinary chemical
products, including veterinary vaccines. For commercial products, the normal form of approval is
through registration. The APVMA also issues permits to allow the limited use of an unregistered product
in certain circumstances, for example to enable collection of data to support an application for
registration (e.g. safety and efficacy). The APVMA can impose conditions on the use of veterinary
products in registrations and permits.
The APVMA has issued a permit to Bioproperties Pty Ltd to allow the supply and limited use of the GM
vaccine, Vaxsafe® ILT, to inoculate up to 2 million broiler chickens for the purpose of conducting
research. The permit includes instructions for the use, storage and disposal of the vaccine, and imposes
biosecurity measures in line with those described above.
Confidential Commercial Information
Some information, including details of the vaccine production process, is under consideration as
Confidential Commercial Information (CCI) under section 185 of the Act. Any confidential information
will be made available to prescribed experts and agencies consulted on the Risk Assessment and Risk
Management Plan (RARMP) for this application.
Parent organism
The parent organism is infectious laryngotracheitis virus (ILTV), the causative agent for infectious
laryngotracheitis (ILT), an acute respiratory disease mainly affecting chickens. Specifically the CSW-1
strain of ILTV, derived from an outbreak in Glenfield NSW in 1959, was used to develop the GM strain.
ILT results in reduced egg production, and can predispose diseased birds to other respiratory pathogens,
causing significant economic losses in the poultry industry worldwide. In Australia, ILT is a notifiable
endemic disease of poultry. The classic signs of ILT are conjunctivitis, gasping, coughing, and extending
the neck forward and upwards with each breath. After an incubation period of 3 to 14 days, increased
mucus forms in the windpipe, often followed by bleeding. Many birds die from this disease due to
suffocation, as the windpipe becomes completely blocked. The virus can spread between chicken farms
in close vicinity via inanimate objects (e.g. clothing), aerosols, or introduction of infected birds.
ILTV also infects pheasants, peafowl and turkeys but does not cause disease in ducks. ILTV does not
infect people or other animals.
The genetic modifications and their effects
To generate the GM vaccine strain, the gene encoding glycoprotein G was removed from the CSW-1
strain of ILTV. Removal of this gene is intended to attenuate the virus, such that it does not cause severe
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Office of the Gene Technology Regulator
disease in vaccinated chickens but is still able to stimulate an immune response which can protect
against later infection by ILTV.
Previous releases of the same or similar GMOs
This GM vaccine has not previously been released into the environment in Australia or elsewhere.
Assessment and consultation process for this DIR application
The Gene Technology Act 2000 and the Gene Technology Regulations 2001 set out requirements for
considering licence applications, including matters that the Gene Technology Regulator (the Regulator)
must take into account before deciding whether or not to issue a licence.
The application qualifies as a limited and controlled release under the Act, as the principal purpose of the
application is to enable the conduct of experiments, and the applicant has proposed limits on the size,
duration and location of the release and controls to restrict the spread and persistence of the GMOs and
their genetic material in the environment. The proposed limits and controls are such that it is
appropriate for the Regulator not to seek advice on the preparation of the risk assessment and risk
management plan (RARMP).
The Regulator will instead consult at a later date on the RARMP that will be prepared in accordance with
the Act. In the interim, copies of the application are available on request from the OGTR. Please quote
application number DIR 154.
The Regulator will seek comment on the consultation RARMP from the public as well as a wide range of
experts, agencies and authorities including the Gene Technology Technical Advisory Committee, State
and Territory Governments, Australian Government agencies and the Minister for the Environment. The
RARMP will then be finalised, taking into account matters raised relating to risks to human health and
safety and the environment, and informs the decision whether or not to issue a licence.
At this stage, the RARMP is expected to be released for comment in May 2017. The public will be
invited, via advertisements in the media and direct mail to anyone registered on the OGTR mailing list, to
provide submissions on the RARMP. The RARMP and other related documents will be available on the
OGTR website, or in hard copy from the OGTR.
More information on Australia’s national scheme for regulation of gene technology and the assessment
process can be found at the Office of the Gene Technology Regulator’s website.
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:
Office of the Gene Technology Regulator, MDP 54, GPO Box 9848, Canberra ACT 2601
Telephone: 1800 181 030
E-mail: [email protected]
OGTR website
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