Public Health Agency of Canada - Regulatory Openness and Transparency Framework

PHAC developed this Regulatory Openness and Transparency Framework (ROTF) with a view to contribute to the protection and promotion of the health of Canadians and their confidence in the regulatory system through timely and open communications on issues important to their well-being. The ROTF is consistent with the Government of Canada’s priorities related to Open Government^{Footnote 1}, helps deliver on the Government’s commitments under the Cabinet Directive on Regulatory Management, and will strengthen and increase the relevance of PHAC’s regulatory policies, through engagement, transparency, and accountability.

To achieve this, PHAC’s regulatory programs will collaborate to identify concrete deliverables and develop by the end of fiscal year 2016-2017 an Implementation Plan. This plan will be posted on the PHAC website and PHAC will annually report on its progress.

Objective

Openness and Transparency will help us achieve our goal by ensuring that PHAC remains a credible voice:

• for Canadians on health protection and promotion issues;
• for regulated parties in communicating a predictable regulatory regime and being authoritative in taking actions on high risk situations

The ROTF outlines concrete actions PHAC is and will be taking to improve access to timely, useful and relevant health, safety, and scientific information for Canadians, while still respecting privacy, confidentiality and security considerations.

Scope

This ROTF applies to all regulatory programs which PHAC is responsible for administering and enforcing:

• Human Pathogens and Toxins Regulations (HPTR), under the Human Pathogen and Toxins Act (HPTA);
• sections of the Health of Animal Regulations under the Health of Animals Act pertaining to the import of animal pathogens;
• Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations (Potable Water Regulations), under the Department of Health Act;
• sections of the Food & Drugs Act pertaining to passenger conveyances and ancillary services; and,
• the Quarantine Act.

Personal information collected pursuant to the legislative framework above will be treated in accordance with the Access to Information Act, the Privacy Act and the Security of Information Act.

Guiding Principles

PHAC’s ROTF is based on the following guiding principles:

• Current, relevant and accessible information
• Clear and consistent language
• Respect privacy, confidentiality and security

Foundational Pillars

PHAC’s ROTF will be grouped under the following pillars:

Inform and Engage

• Canadians have the latest information on important health protection and promotion issues to support their decision-making and increase opportunities for their engagement.

Enable

• Regulated parties have the information they need to fulfil their responsibilities.

Enforce

• Canadians can see how regulated parties follow the rules that have been put in place to protect and promote their health.

Figure 1: Achieving Greater Openness - Public Health Agency of Canada's Regulatory Openness and Transparency Framework

Text equivalent

Figure 1 is a summary of achieving greater openness through the Public Health Agency of Canada's Regulatory Openness and Transparency Framework (ROTF).

The objective of the ROTF is to contribute to the protection and promotion of the health of Canadians and their confidence in the regulatory system through timely and open communications on issues important to their well-being.

The ROTF has three pillars. These pillars are (1) inform and engage, (2) enable and (3) enforce.

1. “Inform and engage” aims to empower Canadians to make informed decisions regarding their health and safety.
2. “Enable” aims to promote compliance by providing current comprehensive information to support regulated parties in fulfilling their responsibilities.
3. “Enforce” aims to demonstrate accountability & authority so that Canadians can see how regulated parties are following the rules in place to protect and promote their health.

Guiding principles of this framework are:

• Current, relevant and accessible information;
• Clear and consistent language; and
• Respect for privacy, confidentiality and security.

Each pillar has proposed activities:

• Post health and safety regulatory information and website renewal is under the inform and engage pillar;
• Greater information to support compliance and develop guidance to address regulated parties’ concerns is under the enable pillar;
• Post inspection reports and post incident notifications is under the enforce pillar.

PHAC is committed to open dialogue with Canadians and Regulated Parties.

Key Activities

Inform & Engage

Canadians want to make informed decisions about their health and their families’ health. We will support them by: providing greater access to plain language health, safety and scientific information. We will also provide Canadians with opportunities to engage in open and meaningful dialogue with us on issues that affect them.

Building on PHAC’s foundation:

• PHAC currently provides information on its website regarding its regulatory programs.

Moving Forward, PHAC will:

Web Renewal

Clearly describe PHAC’s Regulatory Programs on its website and communicate any upcoming regulations through its publically available Forward Regulatory Plan.

• Update and maintain PHAC’s regulatory webpages according to TBS requirements.

Update web content

• Support the migration to Canada.ca by streamlining content and webpage interface, to increase usability and access to information.
• Revise PHAC Regulatory Webpages for plain language and consistent messaging.

Enable

Regulated parties are responsible for following the regulatory requirements that are designed to protect Canadians. PHAC will engage our regulated parties and address their concerns to promote compliance.

Building on PHAC’s foundation

• Issuing Policy Statements (for example, Statements of Administrative Intent related to the Human Pathogens and Toxins Act (HPTA) and Regulations) clarifying and explaining the scope of its statutes and regulations.
• Posting of directives, advisories and notices (for example, Biocontainment Requirements for Specific Pathogens and Pathogen Safety Data Sheets).
• Publication of guidance material (for example, Canadian Biosafety Standard/Canadian Biosafety Handbook and Inspection and assessment guidelines for passenger conveyances and ancillary services related to food, water, and sanitary conditions).
• Development and public release of training modules (for example, training on the principles of biosafety and biosecurity).
• Distributing communication materials such as newsletters or “e-Blasts” containing program updates and regulatory guidance to interested parties.
• Integrated Border Travel Health Program Framework
• Modernized Potable Water Regulations for common carriers and enhanced oversight of food safety under the Food and Drugs Act

Moving Forward, PHAC will:

Address concerns of Regulated Parties through Regulatory guidance

• Develop Regulatory Policy Statements and make them publically available on our website.

Provide greater information to support compliance

• Make available the Agency wide Compliance and Enforcement Framework.
• Develop and publish technical inspection guidelines for potable water inspections for each regulated conveyance sector Publish the Biological Agents list, Pathogen Risk Assessment Methodology, and recommendations of the Advisory Committee on Human Pathogens and Toxins.
• Develop and publish program level Compliance and Enforcement Policy.

Open Dialogue with regulated parties

Utilize the feedback previously obtained from regulated parties and explore new ways to maintain an open dialogue

• Issue e-blasts, publish newsletters, or use other communication tools to inform external parties to Government, as required.
• Develop and post web links to Health Portfolio and other government department partners’ related content.

Enforce

The statutory and regulatory requirements administered by PHAC are designed to protect Canadians and are to be enforced. PHAC verifies compliance of those requirements by conducting inspections and generating reports. Making publically available the results of our inspections will demonstrate to Canadians how the systems that are in place keep them safe and support them to make informed decisions for themselves and their families.

Building on PHAC’s Foundation

• Posting of cruise ship inspections scores under the Travelling Public Program Cruise Ship Inspection Program

Moving Forward, PHAC will:

Post inspection / incident reports

Facilitate regulated parties compliance with regulatory requirements through publically posting inspection findings, non-compliance information, and incident notifications

• Consult, develop and publish the HPTA/R inspection reports.
• Develop and publish components of incident notifications for the HPTA/R.
• Post annual Reports on HPTA/R related activities.
• Develop and publish traveller health assessment statistics.

Implementation

PHAC’s regulatory programs are in the process of identifying deliverables for each of the ROTF pillars that will be incorporated into an Implementation Plan, and rolled out over the next two years.