Internal Audit Report - Animal Pathogen Import Permit Process
Approved by the President May 7, 2019
On this page
- 1.0 Executive summary
- 2.0 Findings and recommendations
- 3.0 Audit conclusion
- Appendix A: Audit criteria
- Appendix B: Glossary
- Appendix C: Management response and action plan
1.0 Executive summary
The Health of Animals Act and its regulations grant the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC) the legislative authority to control the import and use of animal pathogens in Canada.
CFIA is responsible for issuing animal pathogen import permits for indigenous terrestrial pathogens in animal products or by-products, aquatic animal pathogens, bee pathogens, emerging animal pathogens and foreign terrestrial animal pathogens (See Appendix B Glossary for definitions).
Both government and non-government facilities may seek permission to import pathogens for scientific research or other purposes, including public health or hospital diagnostic laboratories; teaching and research laboratories; and vaccine production plants. Facilities seeking permission to import animal pathogens are expected to comply with the Government of Canada's biosafety standards.
Within CFIA, the Operations Branch performs the administrative tasks for the import permit process. The Science Branch has overall responsibility for both managing CFIA's animal pathogen import permit process, including technical review of the applications, as well as certifying that facilities handling these animal pathogens are in compliance with the appropriate biosafety standards.
The objective of the audit was to determine whether CFIA had adequate controls in place to manage the animal pathogen import permit process, including facility certification. The expected controls are defined by the audit criteria, for example: clear roles and responsibilities, availability of information for decision making, performance tracking etc. The audit covered the time period between April 1, 2016 and June 30, 2018.
This audit is important because, if CFIA does not have adequate controls to ensure the animal pathogen import and facility certification process is well managed, then facilities may not handle and store imported animal pathogens in a manner that is commensurate with the risk. This could lead to the introduction and spread of these pathogens in Canada causing harm to human and animal health. In turn, it could have negative consequences for the Canadian economy.
The audit concluded that, overall, CFIA had adequate controls in place to manage animal pathogen import permit issuance and facility certification. However, there were opportunities for improvement in the following areas: the monitoring of facilities' compliance with import permit conditions, and the facility certification and permit issuance process. The audit also concluded that CFIA collaborated effectively with the PHAC to consistently regulate pathogen importation and perform joint facility certification inspections.
The audit recommended that CFIA:
- establish a risk-based process to monitor facilities' compliance with animal pathogen import permit conditions
- strengthen oversight of the facility certification process, including preparing detailed human resource plans for facility inspection activities, preparing guidance to determine enforcement actions in cases of non-compliance, establishing a process to monitor facility certification expiration dates, and formalizing and standardizing mechanisms to mitigate risks to impartiality
- strengthen the controls over the animal pathogen import process, including developing performance indicators, implementing systems to collect and report relevant process information and ensure its distribution to Centre of Administration and Office of Biohazard Containment and Safety (the office) for continuous improvement
1.1 Background
The Health of Animals Act and its regulations grant the Canadian Food Inspection Agency (CFIA, the agency) and the Public Health Agency of Canada (PHAC) the legislative authority to control the import and use of animal pathogens. CFIA regulates the import of the following: indigenous terrestrial pathogens in animal products or by-products, aquatic animal pathogens, bee pathogens, emerging animal pathogens and foreign terrestrial animal pathogens.
Both government and non-government facilities, including public health laboratories, hospital diagnostic laboratories, teaching and research laboratories, and vaccine production plants, may seek permission to import animal pathogens for scientific research or other purposes.
Facilities who wish to import an animal pathogen under CFIA's responsibility, must submit an application to the agency. Following evaluation and approval, a CFIA inspector issues an import permit which then must accompany the pathogen into Canada. The import permit specifies the conditions under which the pathogen is to be handled or stored within the facility. During 2017-18, CFIA inspectors issued 346 animal pathogen import permits.
Within CFIA, roles and responsibilities for the animal pathogen import permit process are as follows:
- Operations Branch has administrative responsibilities for the animal pathogen import permit process, including managing incoming enquiries related to permissions, receiving and triaging of applications, performing administrative reviews (for example, confirming that application forms are complete), invoicing, and issuing approved permits.
- Science Branch has overall responsibility for managing CFIA's animal pathogen import permit process, including assessing applications to determine the risks associated with the pathogen, as well as the conditions and facility containment level required to mitigate the identified risks.
The Science Branch is also responsible for verifying the ongoing compliance of facilities against the Government of Canada's Canadian Biosafety Standard. The Canadian Biosafety Standard sets out the physical containment, operational practice, and performance and verification testing requirements for the safe handling or storing of human and terrestrial animal pathogens or toxins. Facilities where imported aquatic animal pathogens are handled or stored must also comply with the Containment Standards for Facilities Handling Aquatic Animal Pathogens developed by CFIA.
Facilities handling higher risk pathogens require certification, and periodic recertification, through on-site inspections and document reviews conducted by the Science Branch. The staff responsible for these verifications are CFIA designated inspectors. Facilities handling lower risk pathogens require a Compliance Letter from CFIA. To obtain this, they must submit a self-assessment checklist that demonstrates they meet required biosafety standards.
1.2 Objective
The objective of the audit was to determine whether CFIA had adequate controls in place to manage the animal pathogen import permit process, including facility certification.
1.3 Scope
The audit assessed the management controls, as defined by the audit criteria, for the following:
- the animal pathogen import permit process
- facility certification process
The audit covered the time period between April 1, 2016 and June 30, 2018, with particular focus on the animal pathogen import permit process since January 2017 (after the transfer of administrative processes to the Centre of Administration in Operations Branch).
Import permission and facility certification for the food and plant business lines were excluded from the audit.
1.4 Approach
The audit was conducted in accordance with the requirements of the Treasury Board Policy on Internal Audit and the Directive on Internal Audit, which provide mandatory procedures for internal auditing in the Government of Canada.
The audit was planned and performed to obtain reasonable assurance that the audit objective was achieved. A risk assessment was conducted during the planning phase of the audit to establish the scope and criteria (see Appendix A), which were accepted by management. The audit findings were based on a comparison of the conditions in place at the time of the audit with the audit criteria.
Audit procedures included:
- interviews with internal stakeholders, including Science Branch, Operations Branch, Policy and Programs Branch
- document review
- process walkthroughs of animal pathogen import permit issuance and facility certification
- analysis of data provided by Science and Operations Branches related to permits issued, cancelled or renewed, including relevant data from CFIA's Customer Communication Management System and Import Permit System
- testing judgmental samples of animal pathogen import permit files, and of Containment Level 2 and Containment Level 3 certification/recertification files
- collaboration with PHAC's Internal Audit Directorate, which concurrently conducted an audit of PHAC's Biosecurity Program
1.5 Statement of conformance
The audit conforms to the Institute of Internal Auditors' International Professional Practices Framework, as supported by the results of CFIA's internal audit quality assurance and improvement program. Sufficient and appropriate evidence was gathered in accordance with the Institute of Internal Auditors' International Standards for the Professional Practice of Internal Auditing to provide a reasonable level of assurance over the findings and conclusions in this report. The findings and conclusions expressed in this report are based on conditions as they existed at the time of the audit, and apply only to the areas included in the audit scope.
2.0 Findings and recommendations
2.1 Animal pathogen import permit issuance process
The Canadian Food Inspection Agency's animal pathogen import permit issuance process was clearly defined and consistently followed. However, subsequent to issuance, the Office of Biohazard Containment and Safety did not monitor facilities' compliance with conditions stated on the import permit.
To import an animal pathogen, a certified facility must submit an application to the Operations Branch's Centre of Administration for administrative review. The Centre of Administration then sends the application to the Office of Biohazard Containment and Safety in Science Branch where subject matter experts assess and determine the risks associated with the pathogen, and the containment level required to mitigate the identified risks.
Depending on the type of pathogen, the Office of Biohazard Containment and Safety may require the input of other groups within CFIA; for example, the Animal Health Risk Assessment group, which performs detailed risk assessments, or the Foreign Animal Disease working group, which considers the potential effect of a foreign animal disease on Canada's domestic animal population. Following consultations, Office of Biohazard Containment and Safety inspectors are responsible for ensuring that necessary conditions are included in the import permit issued to the facility. These conditions are necessary to reduce the risks associated with the pathogen to an acceptable level.
The audit expected that CFIA would have policies and procedures in place for issuing import permits, and for monitoring compliance with permit conditions.
The audit found that both the Centre of Administration and the Office of Biohazard Containment and Safety documented procedures to be used as guidance for the issuance of import permits, and inspectors consistently used this guidance. However, subsequent to the permit issuance, the Office of Biohazard Containment and Safety did not conduct any monitoring activity to assess facilities' compliance with import permit conditions.
Without sufficient monitoring, CFIA does not know whether the risks associated with handling or storage of pathogens are managed by the facility to the expected level.
Recommendation 1
The Vice President of Science should establish a risk-based process to monitor facilities' compliance with animal pathogen import permit conditions.
2.2 Management controls over facility certification
The release of pathogens from facilities poses a risk to animal and human health. To reduce the risk, Canadian facilities where animal or human pathogens are handled or stored must comply with the Canadian Biosafety Standard requirements. Facilities where imported aquatic animal pathogens are handled or stored must comply with CFIA's Containment Standards for Facilities Handling Aquatic Animal Pathogens.
Within CFIA, the Office of Biohazard Containment and Safety is responsible for certifying that facilities handling or storing animal pathogens are in compliance with the 2 standards named above. The office does this through a combination of on-site facility inspections, review of performance testing documentation, and review of standard operating procedures and policies. Depending on the type of facility and containment level, the certification is valid for a period of 1 to 2 years, and the process for recertification includes review of documentation and may require an onsite visit.
There are 4 containment levels ranging from a basic laboratory (Containment Level 1) to the highest level of containment (Containment Level 4).
| Facility containment level | Government | Non-government |
|---|---|---|
| Containment Level 4 | 2 | |
| Containment Level 3 with Enhanced Oversight | 2 | |
| Containment Level 3 | 9 |
There are also several hundred lower containment level facilities (Containment Level 2) regulated by CFIA, including those run by universities, hospitals, industry and federal and provincial governments. Finally, CFIA also certifies 5 aquatic containment facilities in Canada (1 federal government, 4 non-government).
Since CFIA relies on facility certification to ensure that laboratories comply with biosafety standards, the audit expected that the Office of Biohazard Containment and Safety would have adequate controls in place to ensure a robust and impartial certification process.
The audit reviewed controls such as human resource planning, facility certification/recertification guidance, monitoring facility certification expiration dates, and safeguarding impartiality. It found there were several opportunities for improvement (see Audit Recommendation 2).
Office of Biohazard Containment and Safety human resource planning
The Office of Biohazard Containment and Safety did not develop detailed human resource plans, including identification of the required staff capacity, for its facility certifications.
Facility certifications and recertifications are performed by Office of Biohazard Containment and Safety Biosafety Specialists from the Science Branch. For onsite visits, teams of 2 to 3 specialists perform the certification. From 2015-16 to 2017-18, the number of onsite visits increased from 4 to 28.
In 2017, CFIA approved a policy to allow the import of foreign animal disease and emerging animal disease agents by non-government facilities. This new policy requires enhanced regulatory oversight of facilities that import foreign animal disease and emerging animal disease agents. This enhanced oversight created additional workload for office Biosafety Specialists, including increased frequency of onsite visits, review of ongoing research, detailed review of training records, and increased communication with the facility's Biological Safety Officer.
The audit expected that the Office of Biohazard Containment and Safety would develop detailed human resource plans, including identification of the required staff capacity (resources and competencies), to prepare for the increased workload.
However, the audit found that the office did not develop such plans. Instead, the office explained that it held regular discussions within the unit regarding planning and resourcing, and that statements of qualifications had been developed for some of the certification positions in anticipation of staffing.
In the context of CFIA's new policy governing the import of foreign animal disease and emerging animal disease agents by non-government facilities, and the resulting increased workload, detailed resource planning is important to mitigate the risk that the office will not be able to carry out all required facility certifications and recertifications in an appropriate and timely manner.
Facility certification and recertification guidance
Office of Biohazard Containment and Safety staff has up-to-date checklists that were consistently used for facility certifications; however, there was a lack of guidance to determine enforcement actions for non-compliance.
Facility certification is the formal acknowledgement from CFIA that a facility where animal pathogens will be handled or stored complies with the requirements of the applicable biosafety standards. Certification to Containment Level 3 or Containment Level 4 is required for facilities handling higher-risk pathogens. Recertification refers to the renewal of the facility certification issued by CFIA following a streamlined review process.
The audit expected that the Office of Biohazard Containment and Safety would have policies and procedures in place to guide facility certification and recertification, and to determine the circumstances under which a certification must be suspended, withdrawn or reduced.
The audit found that the office's certification checklists were up-to-date and consistently used to assess compliance with biosafety standards. However, the office did not have documented guidance on what enforcement actions to take when non-compliance was found.
Without documented guidance to determine what enforcement actions should be taken as a result of non-compliance (such as suspension, withdrawal or reduction in certification), there is a risk that office staff may not consistently apply appropriate enforcement actions. This has the potential to result in some facilities continuing to operate without animal pathogen handling or storing risks being appropriately mitigated.
Monitoring facility certification expiration dates
The Office of Biohazard Containment and Safety did not monitor facility certification expiration dates.
The certification of a facility is valid for a fixed period of time (1 to 2 years). Maintaining active certification is necessary to meet the conditions specified on import permits, and renewal of certification is essential to ensure ongoing compliance with biosafety standard requirements.
The audit expected that the Office of Biohazard Containment and Safety would monitor the certification expiration dates of the highest containment level facilities (Containment Level 4, Containment Level 3 and Containment Level 3 with Enhanced Oversight), due to the higher risk of the pathogens handled or stored in these facilities.
The audit found that office verified facility certification status and expiration date when an import application was received. Although the certification statuses of all Containment Level 4 and Containment Level 3 with Enhanced Oversight facilities were up to date, the audit found that the certifications for some of the Containment Level 3 facilities had expired. During the course of the audit, the office ensured that all of the Containment Level 3 facilities were recertified.
Without a mechanism to monitor the status of facility certification prior to expiration, the office cannot take the required action. This puts at risk the credibility and effectiveness of CFIA's certification process.
Safeguarding impartiality
The impartiality of the Office of Biohazard Containment and Safety's facility certification process could be strengthened.
7 of the 13 highest containment level facilities are operated by CFIA, and certified by the Office of Biohazard Containment and Safety. The audit expected that the agency would have implemented mechanisms to ensure the impartiality of the facility certification process.
The audit found that Office of Biohazard Containment and Safety management and CFIA laboratory management reported to different senior executives within Science Branch to mitigate the risk of lack of independence. To mitigate the risk of impartiality, the office had an informal practice of not assigning certification staff to facilities where they recently held operational responsibilities. The office also had a peer review process to review a facility's certification file prior to issuing the certification; however, the process was not standardized.
Without formal and standardized mechanisms to mitigate risks to impartiality, the credibility of the facility certification process and of CFIA as a regulator could be put at risk.
Recommendation 2
The Vice President of Science should strengthen the controls over the facility certification process, including:
- preparing detailed human resource plans for facility certification that identify the required capacity (resources and competencies) to meet policy and oversight requirements
- preparing guidance to determine enforcement actions in cases of non-compliance
- establishing a process to monitor facility certification expiration dates and take action when required
- formalizing and standardizing mechanisms to mitigate risks to the impartiality of the facility certification process
2.3 Performance management of the animal pathogen import permit process
CFIA stores information from the animal pathogen import permit process including permit applications and permits issued. The agency also stores Containment Level 2 self-assessment checklists and compliance letters issued by CFIA confirming that it is acceptable for the facility to work with animal pathogens in accordance with the biosafety standards. CFIA management needs this information for decision making, and for monitoring and continuous improvement of this process.
Information for decision making
The Canadian Food Inspection Agency does not have the information it needs for decision making, effective performance monitoring, and reporting of the animal pathogen import permit process.
The audit expected that key information would be available for decision making, performance monitoring, and reporting on the animal pathogen import permit process.
Office of Biohazard Containment and Safety staff must report to senior management on a quarterly basis regarding the number of facility certifications completed, and the number of import permits and compliance letters issued.
The agency used the following systems to process import permits and compliance letters: Customer Communication Management and the Import Permit System. However, the audit found that these systems did not facilitate analysis as the information was not linked by common fields and definitions, and their reporting capabilities were limited. For example, Customer Communication Management could not produce a report by importer name, nor could it report how many compliance letters were issued.
To overcome system challenges, office staff created a manual import permit and compliance letter tracking tool in MS Excel, but the audit found that the tool was missing a number of files, and the information was incomplete.
The Office of Biohazard Containment and Safety tracked permit file processing times, but it did not do regular analysis of the average processing time to determine trends. The audit performed its own analysis and found that the office's average processing time had improved significantly from 26 days to 10 days between January 2017 and June 2018. The office explained that the improvement was due in part to the hiring of additional staff, and to the transfer of administrative responsibilities to the Centre of Administration.
Without centralized, accessible, complete and accurate information, management does not have the information it needs for decision making, and for effective performance monitoring of the animal pathogen import permit process.
Canadian Food Inspection Agency relationship management with regulated facilities
The Centre of Administration did not have a system in place to track feedback from regulated facilities.
Both the Office of Biohazard Containment and Safety and the Centre of Administration have responsibilities for managing relationships with regulated facilities seeking animal pathogen import permits. The Centre of Administration manages communications with these clients during the application process, while the Office of Biohazard Containment and Safety maintains relationships through ongoing communications with clients via webinars and engagements at the Canadian Biosafety Symposium.
The audit expected that the Centre of Administration, as the primary point of contact with clients, would have a complaints-handling system in place to support the resolution of issues in a timely manner, and monitor facility feedback to support continuous improvement.
The audit found that neither the Office of Biohazard Containment and Safety nor the Centre of Administration had a system to monitor facility feedback and complaints.
During the course of the audit, the Centre of Administration drafted a standard operating procedure to enable the tracking and analysis of feedback and complaints. However, the standard operating procedure did not indicate how the Centre of Administration would share relevant information with the Office of Biohazard Containment and Safety.
To effectively manage stakeholder relationships throughout the animal pathogen import permit process, both the Office of Biohazard Containment and Safety and the Centre of Administration need to be aware of and use facilities' feedback to identify gaps and make improvements as necessary.
Recommendation 3
The Vice President of Science, in collaboration with the Vice-President of Operations and the Vice President of Innovation, Business and Service Development should strengthen the controls over animal pathogen import process, including:
- developing performance indicators for the animal pathogen import permit process
- implementing a system to collect and report relevant information on the animal pathogen import permit process
- ensuring that the implementation of the stakeholder feedback system provides both the Office of Biohazard Containment and Safety and the Centre of Administration with the necessary information for continuous improvement
2.4 Canadian Food Inspection Agency-Public Health Agency of Canada relationship
The Canadian Food Inspection Agency and the Public Health Agency of Canada collaborated effectively to consistently regulate animal pathogen imports and facilities, perform joint inspections, and resolve issues.
In 2013, an Order in Council transferred from CFIA to PHAC the responsibilities for the portion of section 51(a) of the Health of Animals Regulations related to issuing terrestrial animal pathogen import permits, except for foreign animal diseases and emerging animal diseases. As the 2 agencies now jointly administer section 51(a), they must communicate and collaborate effectively to ensure consistent regulation. Where issues arise from the joint administration of the Health of Animals Regulations, the 2 agencies must have a process for resolving them in an effective manner.
The audit expected that the Memorandum of Understanding between CFIA and the PHAC would clearly define the roles and responsibilities of each agency for the Health of Animals Regulations. The audit also expected that the mechanisms in place between the 2 agencies would support collaboration, information sharing, and administration.
The audit found that the agencies worked together collaboratively to resolve issues. They established a Memorandum of Understanding that clearly articulated the roles and responsibilities of each agency, including a mechanism for dispute resolution. Written communications between the 2 agencies to resolve issues was professional and constructive.
The agencies also worked together by performing joint facility inspections when appropriate to help reduce the regulatory burden on regulated facilities.
3.0 Audit conclusion
The audit concluded that, overall, CFIA had adequate controls in place to manage animal pathogen import permit issuance and facility certification. However, there were opportunities for improvement in the following areas: the monitoring of facilities' compliance with import permit conditions, facility certification, and permit issuance process. The audit also concluded that CFIA and the PHAC collaborated effectively to consistently regulate pathogen importation and perform joint facility certification inspections.
Appendix A: Audit criteria
The 4 lines of enquiry with corresponding audit criteria were as follows:
Line of enquiry 1: Management controls over the animal pathogen import permits
- 1.1 Roles and responsibilities within CFIA for issuing animal pathogen import permits are clearly defined and communicated (Management Accountability Framework Criterion AC-2)
- 1.2 Policies and procedures are in place for issuing import permits and for monitoring compliance with permit conditions (Management Accountability Framework Criterion PP-4, Management Accountability Framework Criterion RP-3)
- 1.3 Information is available to support the monitoring of permits (list of permits, pathogens imported, performance of facilities) (Management Accountability Framework Criterion PP-4, International Standard ISO/IEC 17011: 2017)
Line of enquiry 2: Management controls over facility certification
- 2.1 The Office of Biohazard Containment and Safety is structured to safeguard impartiality and it has established mechanisms to support the monitoring and mitigation of risks to impartiality (International Standard ISO/IEC 17011: 2017)
- 2.2 Business planning considers resource requirements for the forecasted facility inspection activities (International Standard ISO/IEC 17011: 2017)
- 2.3 The required competencies for personnel involved in facility inspection activities have been determined and documented (International Standard ISO/IEC 17011: 2017)
- 2.4 Policies and procedures are in place to: (International Standard ISO/IEC 17011: 2017, Management Accountability Framework Criterion PP-4)
- Guide facility certification activities and support consistent achievement of requirements
- Determine in which circumstances a certification will be suspended, withdrawn, or reduced when containment level requirements are not met
- Perform ongoing review of facility certification activities to support continuous improvement
Line of enquiry 3: Stakeholder relations
- 3.1 Animal pathogen import permit application processing time is tracked and action taken as required (Management Accountability Framework Criterion RP-3)
- 3.2 Mechanisms are in place to manage stakeholder feedback, with results reported to management in support of continuous improvement (Management Accountability Framework Criterion CFS-1, Management Accountability Framework Criterion CFS-2)
Line of enquiry 4: Coordination between CFIA and PHAC
- 4.1 Roles and responsibilities between CFIA and PHAC for controlling the import and use of animal pathogens are clearly defined and communicated (Management Accountability Framework Criterion AC-1)
- 4.2 Mechanisms are in place to support coordination and collaboration with PHAC (Management Accountability Framework Criterion AC-4)
Appendix B: Glossary
| Term | Explanation |
|---|---|
| Animal product or by-product | Animal product includes cream, eggs, milk, non-fertilized ova and semen, animal by-product includes blood or any of its components, bones, bristles, feathers, flesh, hair, hides, hoofs, horns, offal, skins and wool, and anything containing any of those things. |
| Aquatic animal pathogen | A microorganism or parasite that can cause disease in an aquatic animal. |
| Canadian Biosafety Standard | The Canadian Biosafety Standard is a harmonized national standard for handling or storing of human and terrestrial animal pathogens and toxins in Canada. It describes the minimum requirements for containment zones in a regulated facility (licence under the Human Pathogens and Toxins Act/Human Pathogens and Toxins Regulations or import permit under the Health of Animals Act/Health of Animals Regulations) as well as best practices for other facilities. The Canadian Biosafety Standard details physical containment requirements for containment zones. It does not apply to facilities handling aquatic animal pathogens. |
| Containment Level | Minimum physical containment and operational practice requirements for handling infectious material or toxins safely in laboratories, large scale production, and animal work environments. There are 4 containment levels ranging from a basic laboratory (Containment Level 1) to the highest level of containment). |
| Containment Level 1 | Requires no special design features beyond those suitable for a well-designed and functional laboratory. General laboratory practices are appropriate for working with non-infectious microorganisms. |
| Containment Level 2 | Practices, safety equipment, and facility design and construction are appropriate for clinical, diagnostic, research or production facilities in which work is done with endemic pathogens that may cause mild to moderate disease but are unlikely to be a serious hazard to the public, livestock or the environment (some organisms and their toxins have the potential for misuse, which is why additional biosecurity measures are required). |
| Containment Level 3 | Practices, safety equipment, and facility design and construction are appropriate for clinical, diagnostic, research, or production facilities in which work is done with indigenous or exotic agents that may cause serious and potentially lethal infections in humans and animals, and that could have serious consequences, if released into the Canadian animal or human population. |
| Containment Level 3 with Enhanced Oversight | Must meet Containment Level 3 requirements but also subject to an enhanced regulatory oversight, which includes but is not limited to:
|
| Containment Level 4 | Practices, safety equipment, and facility design and construction are applicable for work with dangerous and exotic agents that pose a high risk of causing life-threatening disease in humans and animals, which may be transmitted via the aerosol route and for which there is no available vaccine or therapy. |
| Containment Standards for Facilities Handling Aquatic Animal Pathogens | Containment standard for facilities importing aquatic animal pathogens, aquatic animal products and by-products or other substances that may carry an aquatic animal pathogen. |
| Emerging animal disease agent | A pathogen that causes a new infectious disease either resulting from the evolution or change of an existing pathogenic agent, a known infectious disease spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal health. Emerging animal disease pathogens are handled as non-indigenous animal pathogens due to the high risk of serious negative effects associated with these pathogens. |
| Facility | Structures or buildings, or defined areas within structures or buildings, where infectious material or toxins are handled or stored. This could include individual research and diagnostic laboratories, large scale production areas, or animal housing zones. A facility could also be a suite or building containing more than one of these areas. |
| Foreign animal disease agent | A pathogen that causes an animal disease listed in the World Organisation for Animal Health's OIE-Listed diseases, infections and infestations (as amended from time to time) and that are not present in Canada. These pathogens may have serious negative health effects to the Canadian animal population. |
| Handling or storing | "Handling or storing" pathogens, toxins, or infectious material includes possessing, handling, using, producing, storing, permitting access to, transferring, importing, exporting, releasing, disposing of, or abandoning such material. This includes all controlled activities involving human pathogens and toxins specified in Section 7(1) of the Human Pathogens and Toxins Act. |
| Health of Animals Regulations | The Health of Animals Regulations are under the authority of the Health of Animals Act. The Health of Animals Regulations are intended to protect animals and animal health. They provide for the control of diseases and toxic substances that may affect terrestrial and aquatic animals or that may be transmitted by animals to persons. |
| High containment zones | Containment zones (laboratory work areas, animal rooms and cubicles, post mortem rooms, areas for large scale production), including all dedicated support areas, in Containment Level 3, Containment Level 3-Agriculture, and Containment Level 4. |
| Indigenous animal pathogens | A pathogen that causes an animal disease that is endemic in Canada. |
| Pathogen | A microorganisms, nucleic acid, or protein capable of causing disease or infection in humans or animals. |
| Regulated party | An individual or business entity undertaking activities that are regulated by CFIA legislation |
| Risk Group | The classification of biological material based on its inherent characteristics, including pathogenicity, virulence, risk of spread, and availability of effective prophylactic or therapeutic treatments, that describes the risk to the health of individuals and the public as well as the health of animals and the animal population. There are 4 risk groups ranging from lowest risk (Risk Group 1) to the highest risk (Risk Group 4). |
| Terrestrial animal pathogen | A pathogen that causes diseases in terrestrial animals, including avian and amphibian animals, but excluding aquatic animals and invertebrates. |
Appendix C: Management response and action plan
Management response and action plan for animal pathogen import process
Overall management response: Management agrees with the recommendations of the audit.
Recommendation 1: The Vice-President of Science should establish a risk-based process to monitor facilities' compliance with animal pathogen import permit conditions
Management response
Management agrees with the recommendation. As in all areas regulated by the agency, it is the regulated party's responsibility to be in compliance.
| Action plan | Implementation or completion date | Responsible lead(s) |
|---|---|---|
The Office of Biohazard, Containment and Safety (the office) is currently conducting a review of compliance verification practices, including comparing potential non-compliances with other risks managed within the agency (what level of risk exists in other areas and what the compliance verification efforts are in place vs having permit conditions that may not be respected). This comparison will guide decisions on resources allocated to compliance monitoring.
|
Assessing the compliance monitoring options: September 2019 Implementing the selected risk-based compliance monitoring strategy: |
Executive Director, Strategic Business and Partnership, Science Branch |
Recommendation 2: The Vice President of Science should strengthen the controls over the facility certification process, including:
- preparing detailed human resource plans for facility certification that identify the required capacity (resources and competencies) to meet policy and oversight requirements
- preparing guidance to determine enforcement actions in cases of non-compliance
- establishing a process to monitor facility certification expiration dates and take action when required
- formalizing and standardizing mechanisms to mitigate risks to the impartiality of the facility certification process
Management response
Management agrees with the recommendations.
| Action plan | Implementation or completion date | Responsible lead(s) |
|---|---|---|
A formal business and staffing plan is being developed. The business plan will include forecasting for future years and key performance indicators which will trigger the staffing plan. The office will prepare and communicate to staff policy and procedures for enforcement actions in cases of non-compliance, including the revocation, limiting or suspension of permits and laboratory certifications. The office will establish a process to monitor facility certification expiration dates and take action when required.
Staff will be required to update their Conflict of Interest declaration to indicate if they have recently held positions at regulated laboratories upon first starting with the office and yearly thereafter. The office will review its mandate and responsibilities as a regulatory office within Science Branch and document guidance on mitigating impartiality for the program. Informal processes already in place will be formalized in the standard operating procedures and communicated to staff (for example rotation of Biosafety Specialists on certification files, procedure where agency laboratory staff on assignment or recent indeterminate will be assigned to alternate certifications). |
Formal business and staffing plan: March 2019 Preparing and communicating the policy: September 2019 Establishing a manual email reminder system: March 2019 Implementing the preferred option to monitor facility certification expiration dates: December 2019 Conflict of Interest declarations: February 2019 Reviewing mandate and responsibilities: December 2019 Formalizing informal processes in standard operating procedures: September 2019 |
Executive Director, Strategic Business and Partnership, Science Branch |
Recommendation 3: The Vice President of Science, in collaboration with the Vice-President of Operations and the Vice President of Innovation, Business and Service Development should strengthen the controls over animal pathogen import process, including:
- developing performance indicators for the animal pathogen import permit process
- implementing a system to collect and report relevant information on the animal pathogen import permit process
- ensuring that the implementation of the stakeholder feedback system provides both the Office of Biohazard Containment and Safety and the Centre of Administration with the necessary information for continuous improvement
Management response
Management agrees with the recommendations.
| Action plan | Implementation or completion date | Responsible lead(s) |
|---|---|---|
In conjunction with similar processes and agency wide efforts to improve performance measurement, the office is exploring what measurement metrics are required and how to best report moving forward. The office is working to be an early adopter of the My CFIA/Digital Service Delivery Platform to support performance measurement and reporting. In addition, CFIA has completed a project to have access to the Public Health Agency of Canada's (PHAC) client management portal which will allow seamless tracking of laboratory certifications and licenses between the 2 agencies. CFIA will investigate full utilization of PHAC's client management portal, address future improvements (for example statistical analysis, dashboard and reporting functions) and capitalize on opportunities to align performance metrics across the laboratory certification processes. The office will implement a system to collect and report on the relevant information on the animal pathogen import permit process that is in line with agency, branch and directorate needs. |
Selecting performance measurement indicators: Investigating how to use PHAC's client management portal to get information for performance measurement: Implementing a system to collect and report on relevant information: |
Executive Director, Strategic Business and Partnership, Science Branch |
The Centre of Administration has implemented an online tool for tracking, documenting and reporting complaints and feedback received from external stakeholders. The Centre of Administration will update its Standard Operating Procedures to include bi-weekly meetings with the office to share and use stakeholder information for continuous improvement. |
March 2019 |
Senior Director, National Service Centre, Operations Branch |
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