Download decision - Environmental Protection Authority

DECISION
Date
24 January 2017
Application code
APP203065
Application type
To import for release or release from containment a qualifying
organism under section 38I of the Hazardous Substances and New
Organisms Act 1996
Applicant
Pacificvet Limited
Date application received
15 December 2016
Consideration date
24 January 2017
Considered by
The Chief Executive of the Environmental Protection Authority (EPA) 1
Purpose of the application
To release a live attenuated vaccine for Infectious Bronchitis Virus
(Vic S strain)
1.
Summary of decision
1.1
Application APP203065 to import for release or release from containment Infectious Bronchitis Virus
(Poulvac Bron Vic S live attenuated vaccine) (a qualifying organism) was lodged under section 34 of the
Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act).
1.2
I had sufficient information to assess the application. The application was considered in accordance with
the relevant provisions of the Act and of the HSNO (Methodology) Order 1998 (the Methodology).
1.3
I approve the application in accordance with section 38I of the Act, subject to the following controls:
1. The organism may only be released in the form of the vaccine known as Poulvac Bron Vic S vaccine.
2. The vaccine must be used in accordance with the World Organisation for Animal Health (OIE) best
practice including concurrent vaccination of all animals on site using the dosage recommended by
the manufacturer.
1
The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the
Act.
www.epa.govt.nz
2
EPA Decision Application APP203065
2.
Application process
Receipt of the application
2.1
The application was formally received for processing on the 15th of December 2016.
Purpose of the application
2.2
The applicant Pacificvet Limited sought approval to import for release and/or release from containment
Infectious Bronchitis Virus (Poulvac Bron Vic S) in the form of a live attenuated vaccine for use against
Infectious Bronchitis Virus (IBV) in New Zealand poultry.
Information available for the consideration
2.3
The information available for the consideration comprised of the application form and the Staff
Assessment Report.
2.4
I had sufficient information to assess the application. To the extent that the application may not meet
any legislative information requirements, I waive those requirements.
Comments from MPI and DOC
2.5
In accordance with section 58(1)(c) of the Act, the Ministry for Primary Industries (MPI) and the
Department of Conservation (DOC) were advised and provided with the opportunity to comment on the
application.
2.6
DOC noted that feedback from the Department’s veterinarian would follow if they had any specific
concerns regarding the application. No response from the DOC veterinarian was received during the
formal assessment period of the application.
2.7
No response from MPI was received during the assessment timeframe of this application. MPI has
previously noted in a similar application (APP202377) for an IBV vaccine that Ignjatović and Sapats
(2000) recommended that “strong considerations should be given to measures to restrict the
introduction of exotic IBV variants” as an incursion of unrelated IBV strains would impact on the
vaccines needed to control the disease. Introduction of new IBV variants would also increase the pool of
genetically different viruses that circulate on a site, increasing “the likelihood of generating new and
more variable strains through processes such as recombination (Ignjatović and Sapats. 2000).
2.8
I noted that MPI is also reviewing the vaccine as required by their responsibilities under the Agricultural
Compounds and Veterinary Medicines (ACVM) Act 1997, and the Biosecurity Act 1993.
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EPA Decision Application APP203065
3.
The Organism
3.1
The organism approved for release is:
Order: Nidovirales
Family: Coronaviridae
Subfamily: Coronavirinae
Genus: Gammacoronavirus
Species: Avian coronavirus
Accepted name: Avian infectious bronchitis virus (Vic S strain).
Avian infectious bronchitis
3.2
IBV is an enveloped, single stranded positive-sense RNA virus, with a genome length of approximately
27.6 kb, and a high mutation frequency. Genetic diversity in IBV can be generated by point mutations,
insertions and deletions in the genome, and through genetic recombination, all of which occur naturally.
3.3
Avian IBV is a highly infectious disease that has a major impact on the world-wide poultry industry. IBV
is known to cause disease in chickens although other avian species may be infected with IBV-like
coronaviruses, and chickens of all ages are susceptible. IBV-associated disease can significantly affect
egg and meat production, and it can also increase flock vulnerability to secondary infections.
3.4
The virus is trophic for epithelial tissue and primarily affects respiratory, renal and reproductive tissue.
The strains of IBV present in New Zealand are mild and largely impact on production of eggs and egg
quality. The severity of the disease depends on factors including the virulence of the strain, the
presence of secondary infections, flock age, immune status, flock management and environmental
factors.
3.5
Avian Infectious Bronchitis is listed by the World Organisation for Animal Health (OIE) as a notifiable
terrestrial disease. The OIE consider that ill-health, regardless of the cause, is a welfare concern, and
may be exacerbated by poor environmental or husbandry management.
The vaccine
3.6
The organism, IBV (Vic S strain), is the main constituent part of a live attenuated vaccine called Poulvac
Bron Vic S, is produced by Zoetis USA as a bespoke vaccine for the Australian poultry industry.
3.7
Poulvac Bron Vic S is administered to chickens by intranasal (inhaled into nasal cavity), intraocular
(drops into eye) or by spray (directly above the birds), or in drinking water. It is used to provide
protection against IBV-associated disease in the poultry industry.
3.8
Poulvac Bron Vic S is an attenuated vaccine developed from an indigenous variant of an IBV strain (Vic
S) that was isolated in Australia in the 1960s. It is registered for use as veterinary medicine in Australia.
3.9
The New Zealand Strain A and the Vic S variants of IBV share a strong genetic relationship and it has
been suggested that one may be a closely related derivative of the other.
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EPA Decision Application APP203065
4.
Associated approvals
4.1
I note that this approval cannot be used until the vaccine has been approved for use under the ACVM
Act 1997, and any requirements under the Biosecurity Act have been met.
4.2
I further note that this approval is limited to a single strain, IBV (Vic S), and does not allow for the
importation for release of any other exotic strains of IBV as vaccines or in any other form (Control 1).
5.
Potential to establish an undesirable self-sustaining population
5.1
I considered the potential for IBV (Vic S) to establish an undesirable self-sustaining population.
5.2
IBV is temperature sensitive, and will only survive for a few days at room temperature. It is easily
inactivated by common disinfectants such as 70% ethanol, chloroform, or 1% phenol; and is more
stable at low pH than high pH (Ignjatović and Sapats. 2000).
5.3
IBV is shed by infected chickens into the respiratory tract and into the environment by coughing birds,
and in faeces, where it can survive for long periods of time. Contaminated feed, water, litter, footwear,
clothing, utensils, equipment, and personnel are potential sources for the virus. Consequently, IBV
spreads rapidly between chickens, through direct contact, and by aerosol and mechanical means.
5.4
New variant strains of IBV frequently emerge through naturally occurring mutation and recombination. It
is possible for recombination between wild-type and vaccine strains to occur; however, for this to occur,
both the wild-type and vaccine strains would need to be replicating in an individual animal at the same
time.
5.5
Management practices can significantly reduce the potential for such an event occurring. For example,
OIE recommend to mass-immunise all chicks in a flock concurrently, to minimise ‘back passaging’ of the
vaccine virus, thus reducing the potential for recombination (Ignjatović and Sapats. 2000; OIE. 2013). In
addition, vaccination using the manufacturer’s recommended dosage helps reduce the potential for
back-passage reversion that can result from fractional dose application (OIE. 2013).
5.6
I consider that an undesirable self-sustaining population of a variant resulting from a wild type vaccine
recombination event could be problematic, particularly if it were to cause a more significant virulent
disease than IBV strains currently circulating in New Zealand. Consequently, I impose Control 2
specifying that the vaccine must be used in accordance with OIE best practice including concurrent
vaccination (mass application) of all animals on site, at the dosage recommended by the manufacturer.
5.7
Taking into account the controls, I concluded that it is unlikely that an undesirable self-sustaining
population of IBV (Vic S) will establish.
6.
Potential adverse effects
Potentially significant adverse effects on the environment
6.1
I considered the potential for IBV (Vic S) to have an adverse effects on the environment, including
native and valued species and natural habitats. In doing so I noted that IBV-associated disease has only
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EPA Decision Application APP203065
been recorded in chickens and pheasants, and no adverse effects have been reported in other species
from the intended use of the vaccine containing IBV (Vic S).
6.2
The role of wild birds in the persistence and spread of IBV is unknown. It has been suggested that wild
birds act as reservoirs and long-distance vectors of Gammacoronaviruses, which include IBV and some
IBV-like viruses. However, there is no record of IBV-associated disease adversely affecting wild birds.
6.3
As discussed in section 5 of this decision, vaccine virus may recombine with wild type strains of IBV
resulting in a virulent (disease causing) variant; and such a variant could impact adversely on the health
of domestic and commercially reared chickens. However, the potential for this to occur is limited by the
requirements set out in the controls.
6.4
Non-avian species are not susceptible to natural infection with IBV, and there is no record of IBV
infecting non-avian species naturally. I did not identify any potentially significant adverse effect of IBV
(Vic S strain) on non-avian species.
6.5
I concluded that the potential adverse effects from the release of IBV (Vic S) on the environment are not
significant.
Potentially significant adverse effects on the health and safety of people
6.6
I did not identify any potentially significant adverse effect of IBV (Vic S) on human health and safety. IBV
is not known to pose any risks to human health.
Potentially significant adverse effects on the relationship of Māori to the environment
6.7
I did not identify any potentially significant adverse effects from the release of IBV (Vic S) on the
relationship of Māori to the environment.
Potentially significant adverse effects on society and communities
6.8
I did not identify any potentially significant adverse effects from the release of IBV (Vic S) on society and
communities.
Potentially significant adverse effects on the market economy
6.9
I considered the potential for IBV (Vic S) to result in significant adverse effects on the market economy,
with particular regard to the poultry industry.
6.10 As discussed in section 5 of this decision, there is potential for the vaccine to recombine with wild-type
strains of IBV resulting in a more virulent (disease causing) variant; and such a variant could impact
adversely on the productivity of the poultry industry. However, the potential for this occurring is limited
by the controls imposed.
6.11 I also noted that emergence of a more virulent IBV strain could occur naturally through mutation and
recombination of wild type strains currently circulating in New Zealand.
6.12 I concluded that the potential adverse effects from the release of IBV (Vic S) on the market economy
are not significant.
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EPA Decision Application APP203065
7.
Assessment of against legislative criteria
7.1
I assessed the proposed release of the organism, IBV (Vic S), in accordance with the provisions of
section 38I of the HSNO Act as set out below.
Veterinary medicine
7.2
I am satisfied that Poulvac Bron Vic S vaccine, which contains IBV (Vic S), is a veterinary medicine as
defined in section 2(1) of the ACVM Act 1997, as it is a biological compound intended for use in the
direct management of poultry.
Adverse effects of the organism
7.3
In considering the potential adverse effects of the organism, I took into account the controls (set out in
paragraph 1.3) as required by section 38I(3) of the HSNO Act. In addition, I did not take into account
any effects of the veterinary medicine on the animal that is to be treated with the veterinary medicine, as
required by section 38I(4) of the HSNO Act.
Adverse effects on the health and safety of the public
7.4
I am satisfied that it is highly improbable that the organism will have significant adverse effects on the
health and safety of the public, either through the intended dose and route of administration, or through
the formation of an undesirable self-sustaining population.
Adverse effects on valued species
7.5
I am satisfied that it is highly improbable that the organism will have significant adverse effects on any
valued species, either through the intended dose and route of administration, or through the formation of
an undesirable self-sustaining population.
Adverse effects on valued species
7.6
I am satisfied that it is highly improbable that the organism will have significant adverse effects on the
natural habitats or the environment, either through the intended dose and route of administration, or
through the formation of an undesirable self-sustaining population.
Adverse effects on the environment
7.7
I am satisfied that it is highly improbable that the organism will have significant adverse effects on the
environment, either through the intended dose and route of administration, or through the formation of
an undesirable self-sustaining population.
8.
Decision
8.1
After reviewing all of the information contained in the application and the Staff Assessment Report, I
was satisfied that the application met the requirements of section 38I of the Act.
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EPA Decision Application APP203065
8.2
I decided to exercise my discretion and approve the import for release or release from containment of
Avian Infectious Bronchitis virus (Vic S strain), under section 38I of the Act. In accordance with section
38J of the Act, the approval has been granted subject to the following controls:
1. Avian Infectious Bronchitis virus (Vic S strain) may only be released in the form of the vaccine known
as Poulvac Bron Vic S vaccine.
2. The vaccine (known as Poulvac Bron Vic S) must be used in accordance with the World
Organisation for Animal Health (OIE) best practice including concurrent vaccination of all animals on
site, at the dosage recommended by the manufacturer.
24 January 2017
Dr Allan L Freeth
Chief Executive
Environmental Protection Authority
Date
Table 1 Approval number for new organism approved through application APP203065
Organism
Approval code
Order: Nidovirales
Family: Coronaviridae
Subfamily: Coronavirinae
Genus: Gammacoronavirus
Species: Avian coronavirus
Common accepted name: Avian infectious bronchitis virus (Vic S strain)
NOR100163
References
Ignjatović J and Sapats S 2000. Avian infectious bronchitis virus. Re Revue Scientifique et Technique 19: 493508.
OIE, 2013. Avian Infectious Bronchitis. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
Chapter 2.3.2
January 2017