Centre for Biosecurity Compliance and Enforcement Policy

Content

Executive Summary
Policy Objective
Introduction
Scope
Guiding Principles
Roles and Responsibilities
Compliance and Enforcement Activities
Definitions
Review
Contact Information

Disclaimer: This document does not constitute part of the Act(s) or associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies

1. Executive Summary

The Centre for Biosecurity (the Centre) delivers a national Compliance and Enforcement Program under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations (HPTR), as well as of certain provisions of the Health of Animals Act and associated regulations (HAA/HAR) in order to promote safety and security with respect to human pathogens, terrestrial animal pathogens (excluding pathogens that cause emerging or foreign animal diseases (FAD), and toxins.

The Centre's Compliance and Enforcement Policy describes how the national Compliance and Enforcement Program is implemented through the use of different tools and strategies. The policy also describes relevant roles and responsibilities of the Centre and regulated parties. This policy applies to compliance and enforcement by the Centre with respect to human and terrestrial pathogens and toxins regulated under the HPTA/R and the HAA/HAR.

2. Policy Objective

This policy is intended to provide guidance for the Centre's Compliance and Enforcement activities under the relevant Acts and Regulations for which the Centre is responsible. The operational manual and related compliance and enforcement procedures developed by the Centre will aim to be consistent with this policy.

This policy is also designed to promote transparency and increase public confidence in the delivery of the Centre's programs and services. It aims to provide regulated parties with a better understanding of how the Centre will approach its compliance and enforcement responsibilities, and how the Centre makes decisions and can respond to a variety of changes in the compliance and enforcement environment, including incidents of non-compliance, emerging threats, technological advances or new trends in biosafety and biocontainment principles and practices.

3. Introduction

The Centre is Canada's national centre of expertise for the biosafety and biocontainment of human and terrestrial animal pathogens and toxins.

This Centre plays an important role in protecting the health and safety of the public by promoting a minimum standard of practice for all persons conducting activities with human and terrestrial animal pathogens and toxins in Canada. It administers and enforces the HPTA/HPTR, and certain provisions of the HAA/HAR and carries out a range of activities including:

Timely dissemination of biosafety information;
Providing biocontainment and biosafety standards and guidelines;
Providing training to assist with compliance;
Evidence and risk-based interventions;
Issuance of Pathogen and Toxin Licence and Security Clearance;
Ongoing compliance monitoring and verification; and
Regulatory and penal enforcement.

The Centre also aims to enhance global biosafety and biosecurity of human pathogens and toxins through strategic international leadership and collaboration.

The current Canadian Biosafety Standard (CBS) provides technical information, recommendations and guidance to those who design, construct or use laboratories where human and terrestrial animal pathogens and toxins are manipulated for purposes such as diagnostics, research or development. The CBS outlines the physical and operational requirements for laboratories in order to mitigate the inherent risks posed by human and terrestrial animal pathogens and toxins. The CBS is used by the Public Health Agency of Canada to monitor and verify the compliance of regulated facilities under the HPTA/HPTR and the HAA/HAR.

The Centre starts from the premise that the majority of the regulated community will comply with legislative and regulatory requirements if they understand the requirements and have the proper tools to comply with them. The Centre actively works with its regulated parties to encourage and promote the knowledge and understanding of the HPTA/HPTR.

Compliance is normally achieved through a co-operative approach between the regulated party and the Centre. Correcting non-compliance can often be achieved through the development of appropriate corrective measures or other methods. However, when this co-operative approach does not lead to compliance, or when the regulated party is incapable of correcting non-compliance, enforcement actions may be used. In some cases, enforcement actions may be the appropriate initial tool to correct or prevent non-compliance.

This policy identifies guiding principles; outlines roles and responsibilities of the Centre and of regulated parties; describes compliance and enforcement activities; and defines relevant terms in relation to the Centre's compliance and enforcement activities.

4. Scope

This policy applies to any controlled activity under the HPTA/R, and to activities subject to sections 51(a), 51.1(a) and 51.1(b) of the HAR.

5. Guiding Principles

The Centre is committed to adhering to the principles outlined in the Cabinet Directive on Regulatory Management (CDRM), which applies to all departments and agencies involved in the federal regulatory process. The CDRM aims to ensure that regulatory activities result in the greatest overall benefit, by demonstrating tangible results for Canadians, while also aiming to reduce regulatory burden on its regulated parties. Consistent with the CDRM, the following principles will guide the Centre's compliance and enforcement activities:

A. Risk-based

The Centre will employ a risk-based approach to its compliance and enforcement interventions. Actions taken will be proportionate to the seriousness of the non-compliance, and appropriate to the situation.

The Centre will strive to take a progressive approach. The level of intervention will be in accordance with various factors such as:

The level of risk or potential risk;
The degree of potential harm caused by the infraction;
The compliance history of the regulated party;
Whether the regulated party acted with indifference or premeditation;
The likelihood that the problem will recur; and
The likely outcome of each enforcement action.

The Centre is committed to pro-actively identifying and minimizing or eliminating potential hazards to public health, safety and security.

B. Accountable

The Centre is accountable to take compliance and enforcement actions in accordance with relevant statutes and regulations. The Centre will provide timely and adequate training to its staff so that they are qualified and competent to take such compliance and enforcement actions.

C. Transparent

This Compliance and Enforcement Policy will be accessible to regulated parties and the general public.

Compliance is facilitated when regulated parties are aware of and understand legislative and regulatory requirements. The Centre will facilitate compliance with legislative and regulatory requirements by providing clear and timely communications with regulated parties. The Centre is committed to encouraging compliance through information exchange and providing information and tools to regulated parties regarding steps that should be taken to address non-compliance and how to maintain compliance.

D. Predictable, Fair, Consistent

The Centre's oversight of the applicable legislation and regulations will be applied in a fair and consistent manner so as to be appropriate to the circumstances. This will be achieved by:

Implementing this policy in a coherent and uniform manner;
Having trained personnel carry out compliance and enforcement activities;
Publishing a Compliance Activities and Enforcement Continuum to provide the framework used by the Centre for conducting compliance and enforcement activities; and
Implementing an internal audit framework to evaluate consistency of enforcement decisions, verify the quality of the compliance and enforcement activities, and identify potential trends for continuous improvement.

E. Collaborative and Harmonized with Other Jurisdictions

Where appropriate, the Centre will make efforts to collaborate and harmonize with other government organizations, provincial and territorial governments, and international partners to provide an effective compliance and enforcement regime that reflects best practices while it protects the health and safety of the public while promoting regulatory efficiencies and streamlined processes.

F. Flexible

The Centre will review its compliance and enforcement policy and procedures and update as required so that they reflect a changing environment, public expectations and lessons learned.

While these general principles guide the compliance and enforcement activities of the Centre, they do not preclude the use of specific tools or methodologies needed to address health, safety and security risks posed by the unsafe use of human and terrestrial pathogens, and toxins.

6. Roles and Responsibilities

This section provides a brief description of some of the roles and responsibilities of the Centre, regulated parties and other interested stakeholders.

A. Centre for Biosecurity

The Minister of Health has the responsibility for the administration and enforcement of the HPTA and HPTR. This responsibility is carried out on a day-to-day basis by the Centre. As of April 1, 2013, the Agency also became responsible for the portions of the HAA/HAR that deal with the issuance of importation permits and transfer authorizations for terrestrial animal pathogens.

It is the responsibility of the Centre to conduct compliance and enforcement activities in accordance with the relevant legislation, regulations, this policy, and related policies and procedures. Key activities include working with regulated parties to promote, monitor and verify compliance. Other responsibilities include responding to situations of non-compliance in an appropriate fashion, as it is described in the Compliance Activities and Enforcement Continuum.

Inspectors for the HPTA are designated under section 40 of the HPTA and their powers of inspection are outlined in sections 41 to 52. The Agency inspectors for the HAA/HAR are designated through subsections 13(3) of the Canadian Food Inspection Agency Act. The primary role of inspectors is to verify compliance and to prevent or address non-compliance with the relevant legislative and regulatory requirements with the HPTA/HPTR and the HAA/HAR. In general, this activity will be undertaken in this progressive manner. However, some situations may be addressed more appropriately with immediate stronger action such as investigation or prosecution.

When the Centre's graduated approach of the regulatory enforcement is proven to be inefficient, the Centre may move forward with the next activity in the continuum which is the penal enforcement. If the Centre has reasonable grounds to believe that an offence has been committed under the HPTA, the Centre may conduct an investigation. Investigations are conducted for the purpose of carrying out penal enforcement actions for possible prosecution. Where an offence committed under HAA/HAR, CFIA will be responsible to conduct penal enforcement.

Where appropriate, the Centre will work with other federal government organizations and provincial and territorial governments.

B. Regulated Parties

Regulated parties are responsible for ensuring the activities they conduct with human pathogens and toxins are in accordance with all legislative and regulatory requirements. At minimum, every person who knowingly conducts a specified activity involving a human pathogen or toxin is required to take all reasonable precautions to protect the health and safety of the public against the risks posed by that activity. The regulated party is also responsible for, but is not limited to:

Establishment and maintenance of an appropriate laboratory biosafety and biosecurity program;
Compliance with applicable requirements in the current Canadian Biosafety Standard (CBS), and any successor documents;
Meet the licensing and security clearance requirements;
Identification and correction of non-compliance in a timely and appropriate manner;
Development and implementation of acceptable and effective Corrective Action Plans in response to non-compliances identified by the Centre; and
Correction of items requiring rectification as identified by the Centre.

C. Stakeholder Associations

Although Stakeholder associations are not necessarily regulated parties under the HPTA/HPTR or HAA/HAR, past experience has proven that collaboration between them, the Centre and its regulated parties is beneficial. Stakeholder associations customarily communicate legislative and regulatory requirements to their members, and share members' concerns on legislative, regulatory and compliance and enforcement issues with the Centre.

7. Compliance and Enforcement Activities

The Centre performs ongoing compliance and enforcement activities. Information about non-compliance, emerging threats or new technology may trigger the Centre to examine the situation and associated risks to determine compliance and enforcement activities that are appropriate and aligned with the guiding principles set out earlier in this policy.

Activities may be undertaken in a progressive or iterative manner moving through the Compliance Activities and Enforcement Continuum, which outlines the progressive activities that will be employed by the Centre to achieve a coherent Compliance and Enforcement. These activities can be categorized under the following:

A. Compliance Activities

The Centre of Biosecurity believes that promotion of compliance through information, education and transparency, is an effective tool in obtaining conformity with the law. The objectives of the Centre's compliance activities are that organizations successfully achieve compliance with the legislation and guidelines. The Centre has developed accessible tools to promote knowledge and understanding of the regulatory requirements. Compliance activities are delineated into 2 categories: Promotion; and Monitoring and Verification.

A1. Compliance Promotion

Compliance promotion is a proactive tool to help to achieve compliance through education and the dissemination of information. Compliance is facilitated when legislative and regulatory requirements are clearly identified, understood, and accessible to all regulated parties.

The Centre's compliance promotion activities include: the development and delivery of training courses, participation at national symposia, raising awareness, sharing of information on biosafety and biosecurity practices and principles through the Agency website, the publication and distribution of the CBS and guidelines , the development and web posting of Pathogen Safety Data Sheets, and the issuance of biosafety advisories or notifications concerning emerging human or zoonotic pathogens.

The Centre also encourages regulated parties and other interested stakeholders to share information and build networks amongst themselves to disseminate best practices and lessons learned.

It is the Centre's intention to keep abreast of emerging trends, science, technologies and issues relating to the biosafety, biocontainment and biosecurity of human and terrestrial animal pathogens and toxins to inform evidence and risk based decision making.

A2. Compliance Monitoring and Verification

Compliance monitoring and verification involves facilitating and monitoring compliance of activities regulated by the Centre and the verification that these activities are carried out in accordance with the provisions of the relevant Act and Regulations. Compliance monitoring and verification is an ongoing activity including collecting and analyzing information, assessing risk for the issuance of the Pathogen and Toxin Licence and to assessing compliance with legislative requirements through inspection activities.

The Centre monitors compliance through the use of methods such as, but not limited to, on-site inspection of facilities, verification of importing or transferring of human pathogen and toxins, biosafety program evaluation, and analysis of information provided by regulated parties. The Centre may also be notified of suspected non-compliance by complaints, referrals from other provincial and federal regulatory agencies or international parties.

On-site inspections play an important role in compliance, particularly during the verification of compliance. This tool allows the Centre to perform various activities including audits, verification of facilities and operational procedures, collecting and analyzing information from a variety of sources.

When verifying compliance, the Centre considers the level of risk associated with the human pathogen or toxin, as well as the activity undertaken so that the type and frequency of oversight is appropriate for mitigating risk to the health and safety of Canadians.

B. Enforcement Activities

Where the Centre identifies a non-compliance, the primary objective is to manage the risk and have the regulated party comply with the relevant Act and Regulations using the most appropriate level of intervention: generally starting from the least intrusive level of intervention moving in a progressive approach to the most serious. Enforcement activities are delineated into 2 categories: Regulatory and Penal Enforcement.

B1. Regulatory Enforcement

The regulatory enforcement actions of the Centre manage the level of risk, or potential risk, and the degree of intervention in accordance with the risk of the non-compliance. It is further divided into administrative and inspection enforcement activities. The Centre may use one or more tools depending on the evaluation of various factors, which may include but are not limited to the following:

The level of risk or potential risk;
The degree of potential harm caused by the infraction;
The compliance history of the regulated party;
Whether the regulated party acted with indifference or premeditation;
The likelihood that the problem will recur; and
The likely outcome of each enforcement action.

After assessment of a non-compliance situation, the Centre may exercise its regulatory powers. The actions may include but are not limited to the following: issuance of letters of non-compliance; refusal to issue the Pathogen and Toxin Licence; variance or suspension or revocation of the Licence; undertake activities related to seizure, detention, forfeiture or disposal; or issuance of orders by an inspector. The Canadian Food Inspection Agency may also use administrative monetary penalties as a regulatory enforcement mechanism.

In the course of the regulatory enforcement activities, the Centre provides open and transparent communication and information to assist regulated parties in understanding and complying with the legislation.

B2. Penal Enforcement

Besides its regulatory and inspection mandate, the Centre has a law enforcement mandate. Both the HPTA/HPTR and HAA/HAR have offence provisions. Penal enforcement activities under the HAA are conducted by the Canadian Food Inspection Agency's Enforcement and Investigation Services.

The Centre's penal enforcement consists of two activities: investigation and prosecution. An investigation is considered if there are reasonable grounds to suspect that an offence has been committed or when the regulated party is unwilling or unable to correct non-compliance issues. An investigation involves gathering, from a variety of sources, evidence and information relevant to a suspected or potential offence. If the Centre is aware that the intent of the regulated party is to intentionally commit an offence, or cause harm, the Centre is more likely to consider penal enforcement.

Upon the completion of an investigation, a determination can be made by the Centre to move forward with a recommendation to the Public Prosecution Service of Canada for the prosecution of the implicated regulated party.

8. Definitions

Biosafety

Containment principles, technologies, and practices that are implemented to prevent unintentional exposure to infectious material and toxins, or their accidental release.

Biosecurity

Security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens, toxins, and other related assets (e.g., personnel, equipment, non-infectious material, and animals).

Compliance

The state of conformity of a regulated party (including a corporation, institution, and individual) with a statutory and/or regulatory requirement.

Compliance Activities: From the Centre's perspective, compliance activities include:
Compliance Promotion: The actions are taken to assist regulated parties to comply with legislative and regulatory requirements or voluntary agreements. These actions include educational activities and the provision of information on legislation, regulations and policy.
Compliance Monitoring and verification: Actions to maintain regular surveillance in order to evaluate compliance with applicable requirements of legislation and associated regulations, including on-site inspections.
Enforcement: Actions that may be taken by the regulatory authority to compel or induce compliance by the regulated party with the applicable statutory and/or regulatory requirements or to cause a contravention to cease, to prevent future contravention or to impose sanctions on the regulated party for non-compliance.

Inspector

Any person designated as an inspector for the purpose of the administration and enforcement of the HPTA/HPTR, or the HAA/HAR and its associated regulations.

Inspection

Actions undertaken by a regulatory authority on a predetermined cycle or as required, for the purpose of verifying whether or not a regulated party is in compliance with the applicable statutory and/or regulatory requirements, or for the purpose of preventing non-compliance.

9. Review

This policy will be reviewed on a regular basis following the Centre's Director General approval. This will entail a review of Compliance and Enforcement Program documents, such as policies, guidelines and procedures to determine whether this policy has been effective in achieving coherence with its guiding principles.

10. Contact Information

Questions or comments in relation to this policy can be directed to the Director General of the Centre for Biosecurity.
100 Colonnade Road, A.L. 6201A
Ottawa, ON K1A 0K9
613-957-1779 (Phone)
613-941-0596 (Fax)
cindy.evans@phac-aspc.gc.ca

Laboratory Biosafety and Biosecurity

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Date modified:: 2015-12-01

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