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Outcome-based Regulations Policy

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  1. Background
  2. Policy Statement
  3. Policy objectives
  4. Definitions
  5. Scope
  6. Authorities
  7. Guiding Principles
  8. Requirements
  9. Roles and Responsibilities
  10. References
  11. Monitoring and Reporting
  12. Inquiries
  13. Effective Date

1. Background

Rapid advancements in science and technology have led to fundamental changes in the way food and agricultural products are produced, processed, packaged, distributed and sold in Canada. As the sectors that the Canadian Food Inspection Agency (CFIA) regulate constantly evolve their business models and technologies, the CFIA is developing a modern regulatory toolkit to adapt in response to emerging risks while giving industry the flexibility to innovate.

Outcome-based regulations (a type of regulation that focuses on achieving specific and measureable results) can help enable regulated parties and the CFIA to adjust for scientific and technological advancements, new production and processing methods, and changing consumer demands within the regulatory base without compromising health, safety and protection standards.

Outcome-based regulatory requirements specify the desired result that a regulation intends to achieve, rather than describing a specific process or action that must be followed to achieve compliance, as in prescriptive regulations. For example, to prevent risks due to standing water, rather than stipulating the number of floor drains required, an outcome-based requirement would simply state that there must be no standing water and let businesses decide how best to prevent it.

Outcome-based regulatory requirements allow the regulated party to choose measures to meet the requirement, while providing the flexibility to introduce new technologies, processes, and procedures. In following an outcome-based regulatory approach regulated parties can apply cost effective, scientific, and technological measures that best achieve a given regulatory outcome while maintaining or enhancing food safety and protecting plant and animal health.

Outcome-based regulations also hold promise in establishing comparability, and supporting regulatory cooperation with protection and safety regimes in other jurisdictions that are based on similar outcomes.

For a safe and responsive regulatory framework, this policy promotes a consistent approach for using and applying outcome-based regulatory requirements amongst a mix of other regulatory approaches used by the CFIA, including prescriptive regulations. This policy will be supported by a guidance document; additional directives or guidelines may also be developed by those with responsibilities related to this policy, as outlined in section nine of this document.

2. Policy Statement

The CFIA develops and administers outcome-based regulatory requirements when it is appropriate to do so in order to support more agile, responsive regulations.

3. Policy objectives

The objectives of the policy are to promote:

  1. a consistent approach to developing and administering outcome-based regulatory requirements
  2. flexibility in regulations to better support the use of new science and technology while maintaining or improving health, safety and protection
  3. clarity of the roles and responsibilities of the CFIA with respect to outcome-based regulatory requirements

4. Definitions

Outcome-based regulatory requirements
the regulation specifies the desired result that regulated parties must meet, rather than the means by which it must be achieved.
Prescriptive regulatory requirement
the regulation prescribes a specific standard, requirement or process to follow or actions that a regulated party must take in order to achieve compliance.

5. Scope

This policy applies to all:

6. Authorities

The development and administration of any particular outcome-based regulatory requirement is based on authority provided in the relevant Act within the CFIA mandate.

7. Guiding Principles

The following principles help guide decision-making around when and how outcome-based regulatory requirements are developed and implemented.

Safety and protection

Protection of human health and well-being, and the animal and plant resource base are paramount.

Support innovation

Outcome-based regulatory requirements support innovation by providing opportunities for flexibility in adopting technologies and processes to enhance safety and protection or by reducing costs.

Instrument choice

The CFIA determines the effectiveness and appropriateness of using outcome-based regulatory requirements, among other regulatory and non-regulatory instruments, for achieving policy objectives.

Collaborative approach

The CFIA engages with regulated parties to develop effective outcome-based regulatory requirements, as well as guidance material to facilitate compliance.

Continuous improvement

The CFIA measures the effectiveness and performance of its programs, including outcome-based regulatory requirements, to identify areas for improvement and adjusts accordingly.

8. Requirements

  1. Outcome-based regulatory requirements clearly specify the desired result that must be met
  2. In developing and administering outcome-based regulatory requirements, the CFIA takes into consideration international standards and aims to align with trading partners to the extent possible
  3. The CFIA provides clear and specific guidance to support regulated parties in meeting regulatory outcomes
  4. To facilitate compliance, the CFIA develops guidance material to provide examples of practices or procedures that regulated parties may use to help meet outcome-based regulatory requirements
  5. The CFIA requires regulated parties to demonstrate compliance with outcome-based regulatory requirements
  6. The CFIA requires regulated parties to demonstrate the effectiveness of practices or procedures they use to meet outcome-based regulatory requirements
  7. CFIA staff responsible for administering outcome-based regulatory requirements are appropriately trained to support application of the regulations'

9. Roles and Responsibilities

The Regulatory, Legislative and Economic Affairs Division is responsible for reviewing and maintaining this policy and providing advice to CFIA program managers so that outcome-based regulatory requirements are developed as intended.

Policy and Programs Branch managers or risk owners are responsible for developing outcome-based regulatory requirements and guidance materials for regulated parties, engaging with external stakeholders, and providing functional direction to other branches, consistent with the direction set out in this policy. To identify areas of improvement, they are also responsible for reviewing the effectiveness and performance of CFIA's programs, including outcome-based regulatory requirements.

The Operations Branch is responsible for developing guidance and delivering training for the inspectorate. They also oversee the consistent implementation of outcome-based regulatory requirements across the food, animal and plant business lines.

The Communications and Public Affairs Branch is responsible for providing information to regulated parties about CFIA programs and services to promote compliance with outcome-based regulatory requirements.

10. References

The Canadian Food Inspection Agency's Regulatory Framework: Safe and Responsive

Cabinet Directive on Regulation, Treasury Board of Canada Secretariat, 2018

Policy on Regulatory Development, Treasury Board of Canada Secretariat, 2018

11. Monitoring and Reporting

The Outcome-based Regulations Policy will be assessed at least once every five years, or as needed. The assessment will be measured against the policy's stated objectives and whether updates are needed to reflect changes in the CFIA operating environment.

The findings and intended actions from the assessment will be reported to the Vice-President of the Policy and Programs Branch and the relevant branches and appropriate governance committees.

12. Inquiries

For interpretation, clarification or inquiries regarding this policy please contact:

Director
Regulatory, Legislative and Economic Affairs Division
Policy and Regulatory Affairs Directorate
Policy and Programs Branch
cfia.legislation-legislation.acia@canada.ca

13. Effective Date

The date this policy comes into effect on January 7th, 2019

Approval

This document, the Outcome-based Regulations Policy, has been approved by the Acting President of the CFIA

France Pégeot

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Signature

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Date

January 7th, 2019

Date modified: