Pathogen and Toxin Licence

Transcription

1 Public Health Agency of Canada Pathogen and Toxin Licence Memorial University of Newfoundland (Name of Organization) Memorial University, Arts and Administration Building, Room A2026, St., Newfoundland and Labrador, A1C 5S7 (Address) Risk Group 2 Human Pathogen and Toxin Licence under section 18 of the Human Pathogens and Toxins Act AND Risk Group 2 Terrestrial Animal Pathogen Permit under section 160 of the Health of Animals Regulations (Risk group covered by the Licence) Subject to the conditions annexed hereto Validity Period: Date Issued: Issued to: Biological Safety Officer: to , unless otherwise suspended, varied, or revoked Kent Decker Rod Hobbs

2 ACTIVITIES - HUMAN PATHOGENS AND TOXINS LICENCE Subject to the conditions listed below, this licence authorizes the specified activities: Activities Biological Agents Facility description Type of Work Areas Animal Species Condition Names* Health Sciences Centre, 300 Prince Philip Drive, St., Large Animal Zone, Post- Mortem Room, Small Animal Zone Rodents (Mice, Rats, Guinea Pigs, etc.) documentation, In vitro/ In vivo, Incident record, Influenza virus, Movement under HPTR, No SSBA allowed, PAO 18 months, Prions not allowed, RG3 and RG4 pathogens not allowed, Schedule 5, Toxins Marine Institute, 155 Ridge Road, St. documentation, In vitro, virus, Movement under HPTR, No SSBA allowed, PAO 18 months, Prions not Schedule 5, Toxins Page 2 of 8

3 Ocean Sciences Centre, 1 Marine Lab Road, St. Biotechnology Building, Toulinguet Close, St., Small Animal Zone Rodents (Mice, Rats, Guinea Pigs, etc.) documentation, In vitro, virus, Movement under HPTR, No SSBA allowed, PAO 18 months, Prions not Schedule 5, Toxins documentation, In vitro/ In vivo, Incident record, Influenza virus, Movement under HPTR, No SSBA allowed, PAO 18 months, Prions not allowed, RG3 and RG4 pathogens not allowed, Schedule 5, Toxins Science Building, Toulinguet Close, St. documentation, In vitro, virus, Movement under HPTR, No SSBA allowed, PAO 18 months, Prions not Schedule 5, Toxins Page 3 of 8

4 S.J. Carew Building, Arctic Avenue, St. documentation, In vitro, virus, Movement under HPTR, No SSBA allowed, PAO 18 months, Prions not Schedule 5, Toxins *See Conditions section at the end for full description details. You must also comply with the conditions stated under section 4 of the Human Pathogens and Toxins Regulations. Page 4 of 8

5 ACTIVITIES - TERRESTRIAL ANIMAL PATHOGEN PERMIT Subject to the conditions listed below, this permit authorizes the specified activities: Activities Biological Agents Facility description Type of Work Areas Animal Species Condition Names* Health Sciences Centre, 300 Prince Philip Drive, St., Large Animal Zone, Post- Mortem Room, Small Animal Zone Rodents (Mice, Rats, Guinea Pigs, etc.) Contact CFIA, Decontamination, HAR Documentation, In vitro/ In vivo, Incident record, Influenza virus, Prions not Transfer under HAR Marine Institute, 155 Ridge Road, St. Ocean Sciences Centre, 1 Marine Lab Road, St. Animal Introduction denied, Contact CFIA, Decontamination, HAR Documentation, In vitro, virus, Prions not allowed, RG3 and RG4 pathogens not allowed, Transfer under HAR Animal Introduction denied, Contact CFIA, Decontamination, HAR Documentation, In vitro, virus, Prions not allowed, RG3 and RG4 pathogens not allowed, Transfer under HAR Page 5 of 8

6 Biotechnology Building, Toulinguet Close, St. Science Building, Toulinguet Close, St., Small Animal Zone Rodents (Mice, Rats, Guinea Pigs, etc.) Contact CFIA, Decontamination, HAR Documentation, In vitro/ In vivo, Incident record, Influenza virus, Prions not Transfer under HAR Animal Introduction denied, Contact CFIA, Decontamination, HAR Documentation, In vitro, virus, Prions not allowed, RG3 and RG4 pathogens not allowed, Transfer under HAR S.J. Carew Building, Arctic Avenue, St. Animal Introduction denied, Contact CFIA, Decontamination, HAR Documentation, In vitro, virus, Prions not allowed, RG3 and RG4 pathogens not allowed, Transfer under HAR *See Conditions section at the end for full description details. Page 6 of 8

7 CONDITIONS Condition Name CBS CL2 In vitro/ In vivo Decontamination Influenza virus RG3 and RG4 pathogens not allowed Prions not allowed Schedule 5 No SSBA allowed HPTR documentation Incident record Movement under HPTR Toxins PAO 18 months Transfer under HAR Description Ongoing compliance with the containment level 2 (CL2) requirements under the Canadian Biosafety Standard (CBS), as amended from time to time. The authorized activities are limited to in vitro and in vivo laboratory studies into the type of work area and for the animal species specified above. All packaging materials, containers, equipment [animal pens, cages and bedding; when applicable], waste and other articles under the person s control, that come in direct or indirect contact with any of the regulated material shall be decontaminated by a validated procedure before disposal or reuse. This permit only allows activities with Risk Group 2 (RG2) Influenza A strains and exclude Risk Group 3 (RG3) Influenza A H2N2, H5, H7, H9 subtypes and the H1N strain. This document does not authorize activities with Risk Group 3 (RG3) and Risk Group 4 (RG4) pathogens to be performed. This document does not authorize activities with prions to be performed. No person shall conduct any controlled activity with any human pathogen or toxin listed in Schedule 5 of the HPTA. This document does not authorize controlled activities with Security Sensitive Biological Agents (SSBA). documentation pertaining to licence activities involving human to be kept on file for a minimum of 5 years. Records of incidents involving pathogens, toxins, other regulated infectious material, infected animals, or losses of containment to be kept on file for a minimum of 10 years. A person who intends to import, export, transfer or receive a human pathogen or toxin must communicate that intention to the biological safety officer before they make any arrangements for the transaction. Activities with toxins present on the Security Sensitive Biological Agents (SSBA) lists are permitted under or up to the trigger quantity defined in this list. Any work with higher quantity requires a SBBA toxin Pathogen and Toxin licence. The licence holder must submit to the Public Health Agency of Canada a revised Plan for Administrative Oversight addressing the missing information indicated in the Plan for Administrative Oversight Evaluation Report within eighteen months of the issuance of the cited report. The imported material may be transferred or moved to another location which complies with the CBS requirements associated with the risk group and/or containment level of the material transferred. Page 7 of 8

8 HAR Documentation Contact CFIA In vitro Animal Introduction denied documentation pertaining to animal pathogen import permit requirements for, toxins, and other regulated infectious material to be kept on file for a minimum of 2 years following the date of disposal, complete transfer, or inactivation of the imported material. The importation of foreign animal diseases, emerging animal diseases, aquatic, bee pathogens and any live animal, animal product and by-product infected by an animal pathogen are regulated by the Canadian Food Inspection Agency (CFIA). Please contact CFIA to find out their importing requirements. The authorized activities are limited to in vitro laboratory studies into the type of work area specified above. The imported material must not be introduced into laboratory, domestic or wild animals (including birds and fish), unless written authorization is obtained from the Public Health Agency of Canada and/or the Canadian Food Inspection Agency, as appropriate. Page 8 of 8