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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. January 2017 3 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. January 2017 4 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 January 2017 5 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. January 2017 6 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. January 2017 7 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