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Archived - Questions and Answers: Outcome-based Regulations Policy

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What are outcome-based regulations?

Outcome-based regulations specify the desired result that regulated parties must meet, rather than the means by which it must be achieved.

Outcome-based regulations allow us to maintain high standards for health, safety and protection while providing flexibility for industry to innovate, and allowing the CFIA's regulations to keep pace with advances in science and technology.

Here are three illustrative examples of the difference between prescriptive and outcome-based regulations

Prescriptive regulation Outcome-based regulation
Example 1 When transporting animals, the temperature in the conveyance must be maintained between 5 and 30 degrees Celsius. Animals must be transported in a manner that does not expose them to adverse weather or environmental conditions that can lead to suffering, injury or death and every animal is provided with adequate ventilation during transportation.
Example 2 Where a low temperature is required for the preservation of a meat product, the temperature in a room or area of a registered establishment where that meat product is processed, packaged, labelled or handled shall not exceed 10 degrees Celsius. The temperature and humidity in a facility where a food is manufactured, prepared, stored, packaged, and labelled must be maintained at levels that are appropriate for the food and the activity being conducted.
Example 3 Equipment must be raised at least 1 metre above the ground to prevent the risk of contamination. Equipment must be installed in a manner than does not pose a risk of contamination.

Who benefits from outcome-based regulations?

The Canadian public

Canadians can trust that the health, safety and protection of the plant, animal and food supply are maintained, or improved, as regulated parties are afforded increased flexibility to continuously improve and innovate to meet standards consistently and effectively.

Regulated parties

Regulated parties have more flexibility to innovate and leverage the latest advancements in science and technology. They are able to choose the most efficient and effective manner to meet a required outcome while still meeting all health, safety and protection standards.

Trade partners and exporters

Many of Canada's trading partners, such as the United States and Australia, are adopting or have already adopted outcome-based approaches. The continued alignment of regulatory systems allows Canada to maintain its role as a global leader and supports market access for Canadian products.

The CFIA

The CFIA's outcome-based regulations can better keep pace with innovations in science and technology, without requiring lengthy amendments through the regulatory development process.

Why did the CFIA develop an Outcome-based Regulations Policy?

The CFIA is developing a modern regulatory toolkit that includes outcome-based approaches to help the CFIA and regulated parties keep pace with scientific and technological advancements, new production and processing methods, and changing consumer demands. This policy was developed to provide clear direction for consistently developing and administering CFIA's outcome-based regulations. It also sets out the related roles and responsibilities of various branches within the Agency.

How was the policy developed?

As part of the 2013 Food Safety Regulatory Forum, the CFIA launched an online consultation on the discussion paper Foundations for an Outcome-based Approach and later published a summary report of the findings.

As regulations continue to be modernized, the CFIA has conducted extensive consultations with various stakeholders. Within the Agency, employees were also consulted on the internal implications of an Outcome-based Regulations Policy. The feedback received from the internal consultation was used to strengthen the final policy document. The changes made include slight modifications for clarity and improving policy direction, as well as expanding on the Roles and Responsibilities section. The implementation plan was modified to clearly outline the ways in which the CFIA would monitor the development of regulatory provisions and provide training and guidance to staff. Question eleven, below, more clearly describes when and what type of training will be given. These consultations provided valuable insights from a variety of stakeholders on outcome-based regulations. The CFIA also considered other sources in developing the policy, including:

How does the policy contribute to building a modern regulatory toolkit?

As outlined in the CFIA's Responding to Today, Building for the Future framework, outcome-based regulations are a central component of the CFIA's modern regulatory toolkit and will allow us to continue to protect food, plant and animals against emerging risks, while supporting industry innovation and market access. Outcome-based regulations allow us to maintain high standards for health, safety and protection while providing flexibility for industry to innovate, and help the CFIA and regulated parties keep pace with advances in science and technology.

The Outcome-based Regulations Policy provides consistent and clear direction to help us achieve this.

How does this policy align with the Treasury Board Secretariat's Regulatory Review and current government Policies and Directives?

In Budget 2018, the government announced its intention to pursue targeted regulatory reviews to identify bottlenecks and areas for improvement in regulation. The Agri-food and Aquaculture sector is a focus of the first round of these reviews and early action items and initiatives for the sector to begin implementing have been announced. This strategy for regulatory modernization and reform will help the government approve new products and services, simplify regulations for businesses, reduce costs, and support innovation and greater collaboration. The CFIA's Regulatory Framework and this policy will help support the goals of the review, and will be revised as necessary to align with and address key outcomes from the review and any forthcoming policy and guidance in support of the Cabinet Directive on Regulation.

The CFIA's Outcome-based Regulations Policy aligns with the Treasury Board Secretariat's, Cabinet Directive on Regulation, Policy on Regulatory Development, and the outcomes from the Regulatory Review in definitions, terminology, goals, and guidance. The policy and its supporting documents will be reviewed regularly to promote their continued application and relevancy.

Does this mean that prescriptive regulations will no longer exist?

No. Not all regulatory requirements are suitable for the outcome-based approach. To best mitigate risks to food safety and the protection of Canada's animal and plant resource base, the CFIA will continue to use a mix of outcome-based and prescriptive requirements. In fact, many of the CFIA's existing regulations combine different regulatory approaches.

In addition, many regulated parties will need to continue to meet prescriptive regulatory requirements that were not developed by the CFIA, such as Health Canada's Food and Drugs Act and Regulations and certain foreign country requirements.

How does the CFIA decide when to use outcome-based regulations?

A number of factors will be considered when determining whether or not it is appropriate to use an outcome-based regulatory provision. These may include the level of risk, the safety and protection standards associated with regulated parties' activities, the anticipated benefits of flexibility and/or innovation, as well as industry considerations, amongst many other factors.

Guidance material for staff that develop regulations and programs has been drafted to support them in determining whether regulatory provisions lend themselves to being outcome-based.

When will the Agency begin developing outcome-based regulatory provisions?

The Agency has already begun to develop several regulations that contain outcome-based provisions. This includes the Safe Food for Canadians Regulations, and regulations which are currently under development, such as the Feeds Regulations, 2019. As new regulations are created or existing regulations are amended, the suitability of outcome-based provisions will be considered, in alignment with the requirements found in the Treasury Board's Cabinet Directive on Regulation and the CFIA's Outcome-based Regulations Policy.

Will training be provided to support the implementation of outcome-based regulations?

During the CFIA's internal consultation on the Outcome-based Regulations Policy, the topic of training and guidance was raised. To support consistency, the CFIA will continue to provide training and guidance to staff:

For inspectors

The CFIA will continue to verify regulated parties' compliance with regulatory requirements, including those that are outcome-based.   As with any new or amended regulation that the CFIA develops, program and operational staff work together to develop training plans to provide staff training on new or revised requirements, as needed.  Given that outcome-based provisions are unique to each regulation, guidance will continue to be developed on an as needed basis to support the development of new skills or competencies that may be required to administer the regulations. Guidance materials will also be developed for the inspectorate to support accurate and consistent administration of the regulations prior to the coming into force of any new or amended provisions, including those that are outcome-based.

Outcome based-regulations do not lower safety standards or allow companies to cut corners. ‎While the CFIA will be open to innovation, it will be vigilant in maintaining high health, safety and protection standards.

For regulatory and program staff

In addition to the final version of the policy, guidance materials will be revised in spring 2019 to support regulatory developers and program staff in continuing to develop outcome-based provisions consistently and when appropriate.

What will be the impact of outcome-based regulations for regulated parties?

By focusing on outcomes instead of prescribing processes or actions, outcome-based regulations allow regulated parties to choose the process by which they meet the requirements, which provides the flexibility to introduce new technologies, processes, and procedures.

The CFIA recognizes that some regulated parties, in particular micro and small businesses, may require additional support to meet requirements. The CFIA is committed to helping these regulated parties adapt to outcome-based requirements by providing up-to-date guidance (such as, model systems, technical references) that provide examples of how compliance could be achieved. Access to support services such as Ask CFIA will also be available to help regulated parties understand their regulatory requirements.

What steps will the CFIA take to help ensure the policy is effectively implemented?

The implementation plan was refined following the feedback received during the internal consultations. The implementation plan outlines a series of activities that are designed to help achieve the policy objectives, and will be implemented upon publication. The planned activities draw from Safe Food for Canadians Regulations best practices such as the development of guidance materials and training, amongst others.

What are the next steps?

On an ongoing basis, the CFIA will continue to implement and monitor the implementation of the CFIA's Outcome-based Regulations Policy. This may include the development and administration of internal surveys, analysis and reporting, which may lead to the revision of the policy and implementation plan on an as needed basis.

The CFIA will continue to monitor the development of all new and amended regulatory provisions to assess their appropriateness. As new regulations are created or existing regulations are amended, the suitability of outcome-based provisions will be considered, in alignment with the requirements found in the Treasury Board's Cabinet Directive on Regulation and the CFIA's Outcome-based Regulations Policy. As part of the implementation plan, internal guidance for those developing new regulations or amending existing regulations is being revised.  This internal guidance will provide additional direction to program and regulatory officers and is targeted for completion in spring 2019.

Who should I contact if I have questions?

Questions should be directed to the Regulatory, Legislative and Economic Affairs Division at cfia.legislation-legislation.acia@inspection.gc.ca

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