EPA advice for application APP203705 Staff Assessment Report February 2019 APP203705: To determine the new organism status of: Tremovirus A (Avian encephalomyelitis virus) Chicken anaemia virus (CAV or CIAV) Fowlpox virus Gallid alphaherpesvirus 2 (Marek’s disease serotype 1 virus) Gallid alphaherpesvirus 2 (Marek’s disease serotype 2 virus) Maleagrid alphaherpesvirus 1 (Marek’s disease serotype 3 virus) Eimeria acervulina, E. brunetti, E. necatrix, E. tenella and E. maxima Purpose To determine if various live poultry organisms in vaccines are new organisms under section 26 of the HSNO Act Application number APP203705 Application type Statutory determination Applicant Pacificvet Limited Date formally received 23 January 2019 1 Executive Summary and Recommendation Application APP203705, submitted by Pacificvet Limited, seeks a determination on the new organism status of: Tremovirus A (Avian encephalomyelitis virus) Chicken anaemia virus (CAV or CIAV) Fowlpox virus Gallid alphaherpesvirus 2 (Marek’s disease serotype 1 virus) Gallid alphaherpesvirus 2 (Marek’s disease serotype 2 virus) Maleagrid alphaherpesvirus 1 (Marek’s disease serotype 3 virus) Eimeria acervulina Eimeria brunetti Eimeria necatrix Eimeria tenella Eimeria maxima After reviewing all of the available information and completing a literature search concerning the organisms, EPA staff recommend that Tremovirus A (Avian encephalomyelitis virus), Chicken anaemia virus (CAV or CIAV), Fowlpox virus, Gallid alphaherpesvirus 2 (Marek’s disease serotype 1 virus), Gallid alphaherpesvirus 2 (Marek’s disease serotype 2 virus), Maleagrid alphaherpesvirus 1 (Marek’s disease serotype 3 virus), Eimeria acervulina, E. brunetti, E. necatrix, E. tenella and E. maxima are not new organisms for the purpose of the HSNO Act based on evidence that these organisms have been identified and present in New Zealand since before 29 July 1998 when the HSNO Act came into effect. 2 EPA advice for application APP203705 Table of Contents Introduction and background ……………………………………………………………4 Organism description…………………………………………………………………………4 Review of information………………………………………………………………………14 Recommendation………………………………………………………………………...…...15 Appendix 1: Correspondence with ACVM..…………………………………...…...16 References…………………………………………………………………………………….....18 Appendix 2: Decision pathway……..…………………………………………………..20 3 Introduction and background On 14 September 2018, Pacificvet Limited applied to the EPA under section 26 of the HSNO Act seeking a determination on the new organism status of Tremovirus A (Avian encephalomyelitis virus), Chicken anaemia virus (CAV or CIAV), Fowlpox virus, Gallid alphaherpesvirus 2 (Marek’s disease serotype 1 virus), Gallid alphaherpesvirus 2 (Marek’s disease serotype 2 virus), Maleagrid alphaherpesvirus 1 (Marek’s disease serotype 3 virus), Eimeria acervulina, E. brunetti, E. necatrix, E. tenella and E. maxima. The EPA requested comment on the application from the Department of Conservation (DOC) and the Ministry for Primary Industries (MPI). MPI did not make any comments on the application but confirmed the registration of vaccines under the ACVM Act. DOC stated that the evidence presented by the applicant clearly indicated that the organisms were present in New Zealand prior to 1998 and therefore, should not be listed as new organisms. The Agricultural Compounds and Veterinary Medicines (ACVM) group of MPI confirmed the approved registrations of the vaccines referred to in this application (Appendix 1). The applicant considers these species as not new organisms and to support this claim, the applicant provided evidence to demonstrate that each of these organisms are present in New Zealand. The evidence consisted of the identification and use of these microorganisms in live attenuated vaccines in New Zealand since before 29 July 1998 when the HSNO Act came into effect. In addition, the applicant provided evidence to support these microorganisms being present in New Zealand based on scientific literature dating back to the 1970s and the ubiquitous nature of these organisms due to the widespread cases of infection and live attenuated vaccine usage around the world. Section 2A(1) of the HSNO Act prescribes that a new organism is, in part, an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998. It is against this criterion that we evaluated the evidence available for the organisms in the application. Description of organisms Tremovirus A (Avian encephalomyelitis virus) Taxonomic Unit Classification Group Group IV ((+)ssRNA) Order Picornavirales Family Picornaviridae 4 EPA advice for application APP203705 Genus Tremovirus Species Tremovirus A Common name Avian encephalomyelitis virus (AEV) Tremovirus A, also known as Avian encephalomyelitis virus (AEV), causes avian encephalomyelitis in chicks over 3-4 weeks old. It is characterised by ataxia, tremors and weakness or paralysis of the legs and was first reported by Jones in 1932. It was later demonstrated that AEV could be controlled by vaccination (Schaaf & Lamoreux, 1955). A vaccine was developed in 1961 using isolates from the brains of clinically affected two-week old chicks (Calnek, Taylor & Sevion, 1961). The subsequent use of vaccines had reduced the number of disease outbreaks (Howell, 1992). AEV was first described in New Zealand by Howell and Bell (1987) and the disease was linked to a series of egg production drops in 1977 in the North Island. Between 1980 and 1982, pooled samples from 40 New Zealand laying flocks, all unvaccinated, were tested and AEV was detected in 47% of these flocks (Howell & Bell, 1987). Furthermore, AEV was described as endemic in New Zealand by Manktelow et al (1988). Following on from Howell and Bell’s discovery of AEV antibodies in 1987, Howell described the virus and its presence in New Zealand in 1992 (Howell, 1992). Three live attenuated vaccines containing AEV have been developed and registered under the Agricultural Compounds and Veterinary Medicine (ACVM) Act (see Table 1 below). They have been historically used in New Zealand to combat AEV with the earliest vaccine, AE-VAC, having been developed, registered and used from 1970 onwards in New Zealand. AEV has also been identified as a common endemic disease in chicken flocks in New Zealand by Watts in 2013 which, based on the evidence, suggests an ongoing presence of AEV in New Zealand. Registered vaccines Table 1: Registered vaccines for avian encephalomyelitis virus under the ACVM Act (1997). Information taken from the MPI ACVM register. Name Reg. date Reg. no Company Ingredients Strain AE-VAC 15/01/1970 A001515 Pacificvet Ltd AEV Salsbury AE-67 AE-Poxine 11/10/1972 A004361 Pacificvet Ltd FPV1, AEV Salsbury AE-67 1 FPV: Fowlpox virus. 5 Nobilis AE + POX 26/11/1990 A006061 Schering-Plough FPV, AEV Unknown Animal Health Ltd Chicken anaemia virus Taxonomic Unit Classification Group Group II (ssDNA) Order Unassigned Family Circoviridae Genus Gyrovirus Species Chicken anaemia virus syn. Chicken infectious anaemia virus (CAV or CIAV) Common name See above Chicken anaemia virus (CAV) or Chicken infectious anaemia virus (CIAV) is also known as gyrovirus. The virus was first described in Japan in 1979 (Yuasa, Taniguchi, & Yoshida) and has been isolated from chickens worldwide. Infection is characterised by anaemia, haemorrhages and atrophy of the thymus and spleen in 2-3 week old chicks. The virus is controlled by uniform inoculation with a live strain vaccine of CAV to breeding chickens during rearing and this prevents vertical transmission (Pattison et al. 2008). The Ministry of Agriculture and Forestry (MAF) published a review in 1991 stating that chicken anaemia agent is present in New Zealand, is probably widespread and has been here for a while. The report advised that no specific safeguards against its presence in imported poultry meat are warranted (MacDiarmid, 1991). The presence of CAV was identified in New Zealand by Howell (1992) by isolating the virus from bone marrow, liver or lymphoid organs of infected young chicks. Similar results were found by isolating CAV DNA from infected chicks in 1992 (Tham & Stanislawek, 1992) and following on from this research, vaccination of poultry breeder flocks with a live vaccine has become standard practice in New Zealand. CAV was reportedly isolated from diseased birds in five separate flocks of broiler chickens in 1991 (Stanislawek & Howell, 1994). CAV has been identified as a common disease in chicken flocks in New Zealand (Watts, 2013). Furthermore, the two live attenuated CAV vaccines listed below in Table 2 are in current use in New Zealand. These two vaccines have been registered in New Zealand under the ACVM Act. 6 EPA advice for application APP203705 Registered vaccines Table 2: Registered vaccines for chicken anaemia virus under the ACVM Act (1997). Information taken from the MPI ACVM register. Name Reg. date Reg. no Company Ingredients Strain AviPro Thymovac 05/02/2003 A009132 Pacificvet Ltd CAV Cux-1 Circomune 08/05/2017 A011331 Pacificvet Ltd CAV del-ros strain Fowlpox virus Taxonomic Unit Classification Group Group I (dsDNA) Order Unassigned Family Poxviridae Genus Avipoxvirus Species Fowlpox virus Common name See above Fowlpox is an endemic disease in New Zealand caused by viruses of the genus Avipoxvirus, which affect many avian species. The term ‘fowlpox’ initially included all avian pox infections but now refers only to the disease in chickens (Tripathy & Reed, 2013). In chickens, fowlpox causes proliferative, wart-like