CFIA Incorporation by Reference Policy

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1. Background

The Canadian Food Inspection Agency (CFIA) strives to use regulatory approaches that reduce unnecessary regulatory burden, provide clarity and flexibility in regulations, and support innovation and changes in science and technology. Among the various regulatory tools available, certain legislation that CFIA administers or enforces grants CFIA the authority to use incorporation by reference (IBR) in regulations provided certain requirements are met (see Authorities section).

IBR is a drafting technique that introduces the content of an internal (CFIA) or external (non-CFIA) document (such as, a policy, directive, list, or standard) into a regulation without having to reproduce the document's text in the regulation. If a document is incorporated by reference into regulations, the incorporated wording has the same effect as if it appeared in the regulations.

External documents

"External document" means any document not generated by CFIA, including, but not limited to, other government departments, agencies, organizations, Crown corporations as well as Canadian and international associations and organizations.

IBR supports a responsive regulatory system that adapts quickly to industry and consumer concerns. For example, CFIA could propose a regulatory amendment that replaces a food grade list in a regulatory Schedule with an IBR document. Once approved, this approach would allow CFIA to more effectively update the list in response to scientific advancements or changes in international trade arrangements. CFIA can also incorporate documents created by an external party. These non-CFIA parties include other governmental departments, agencies or organizations (OGDs) (for example, Canadian General Standards Board) or international or third-party organizations or associations (for example, International Organization for Standardization).

In CFIA's regulatory toolbox, IBR, where appropriate, is only one tool among many to address policy issues. CFIA follows the Cabinet Directive on Regulation and the Treasury Board (TB) Policy on Regulatory Development, which include matters relating to IBR. This policy builds on these directives by setting out several guiding principles, as stated below. This principles form the foundation for how CFIA chooses and maintains documents incorporated by reference in regulations that it administers.

2. Policy statement

CFIA is committed to the principles of accessibility, transparency, consistency, reasonableness, and clarity when using IBR in regulations.

3. Policy objectives

The objectives of this policy are to:

  1. set out the general principles that guide selecting and modifying incorporated documents;
  2. outline the process for document selection and modification; and,
  3. specify CFIA's roles and responsibilities related to IBR.

4. Definitions

Static incorporation by reference

A static reference refers to incorporating a document as it exists on a particular date or time. Static references normally include phrases such as "issued on" or "as of date" in the regulatory text. Any future modifications made to the document would not take effect in the regulations, unless there was a corresponding regulatory change. In this case, the originally referenced version would still be in force.

Ambulatory incorporation by reference

An ambulatory reference refers to incorporating a document in a way that allows the author to modify the document. Once modified, the new version would be in force without needing to change the regulations. Unlike static references, ambulatory references do not mention a specific version or date of the document. They normally refer to the document "as amended from time to time".

Incorporation by reference inventory

The Incorporation by Reference Inventory is a list of all documents incorporated by reference in regulations that CFIA administers. This inventory is available on CFIA's website and provides hyperlinks to the incorporated documents to facilitate accessibility for stakeholders.

5. Scope

This policy applies to all documents incorporated by reference in regulations that CFIA administers.

6. Authorities

For regulations made by the Governor in Council, the authority to incorporate a document by reference comes from the Acts that CFIA administers. The Acts listed below contain specific requirements or exceptions on incorporating documents by reference in their regulations:

The Statutory Instruments Act (ss. 18.1 through 18.7) also provides authority for IBR made under any Act of Parliament, including Ministerial regulations, provided certain requirements are met. Where authorities in the CFIA-administered Acts referred to above have a broader application, these authorities are not limited by authorities in the Statutory Instruments Act.

7. Guiding principles

CFIA selects and maintains documents incorporated by reference based on the guiding principles of accessibility, transparency, consistency, reasonableness, and clarity. This means that documents incorporated by reference need to be accessible to stakeholders and easily understood. Also, these documents should be created and reviewed in an open, transparent, consistent, and inclusive way that meaningfully engages the public. These principles are further detailed below under "CFIA Requirements".

Consistent with Canada's official language policy, all CFIA-generated documents will be available in both English and French. Unilingual external documents can be incorporated by reference when there is a legitimate reason to do so. In this case, CFIA would issue guidance in both official languages (see TB Policy on Regulatory Development).

8. CFIA requirements

Document selection

Once CFIA identifies that meeting regulatory requirements and/or policy objectives is best met through incorporating a document, in whole or in part, CFIA follows a consistent approach. During this process, CFIA conducts a case-specific analysis supported by careful consideration of factors (see Annex A) and internal and external consultations. This scope of the analysis assists CFIA in understanding the unique complexities of the impacted sector (for example, industry irritants and needs, technological advancements and limitations, size and distribution of stakeholder groups, level of established relationship with CFIA, etc.). From this information, CFIA determines if a document is appropriate for IBR. At a minimum, the document must meet certain legal requirements for incorporation and adhere to this policy's guiding principles.

The Regulatory Impact Analysis Statement (RIAS) that accompanies a regulatory proposal involving an IBR document will include the supporting rationale for selecting the document to incorporate by reference. In addition, the RIAS will identify in the cost-benefit analysis any projected costs or benefits attributed to the proposed document for incorporation. After the regulatory proposal that includes the IBR document(s) is pre-published in the Canada Gazette, Part I, stakeholders will have the opportunity to comment on the proposal.

Once the regulatory proposal is published in the Canada Gazette, Part II, CFIA will update its online Incorporation by Reference Inventory to include a link to locate the document(s) incorporated by reference in the regulations in both official languages, as applicable. Relevant guidance will also be available, when applicable.

Proposed modifications to incorporated ambulatory documents

When modifications are proposed to an existing internal or external ambulatory document, CFIA will consider the potential impact on administrative burden and the original cost-benefit analysis. From this information, CFIA will decide the proper course of action. This could include moving forward with modifying an internal document, accepting a modification to an external document or pursuing another regulatory alternative (see Annex B – External Documents). For approved or accepted modifications, CFIA will follow two distinct processes for internal and external documents (see Annex B).

Modifications to ambulatory incorporated documents do not go through the Canada Gazette process. To support transparency, CFIA will notify stakeholders and trading partnersFootnote 1 of any proposed modifications to ambulatory incorporated documents. For CFIA-generated documents, CFIA intends to provide stakeholders with an opportunity to comment on the proposal, unless the proposal addresses an immediate risk to health or safety, a minor administrative adjustment or a consequential modification (see Annex B – Internal Documents). If consultations are held, CFIA will provide a summary of the comments received on its website and indicate if it plans to adopt the modification(s) through a notification. For external documents, CFIA will direct stakeholders to the method of consultation provided by the document's administrator and to any summaries developed, if applicable.

Once a new version of an incorporated document is in effect, CFIA will update the Incorporation by Reference Inventory, as necessary. Previous versions of the IBR document(s), along with a summary of the modifications, will be archived, when feasible.

Applying a transition period may be considered for regulated parties to adjust their practices and procedures to the modified ambulatory document. The length of the transition period will be based on considerations relating to the readiness of impacted stakeholders, including the time needed to adjust for compliance.

9. Roles and responsibilities

As part of the regulatory process, the Department of Justice (DOJ) will be asked to review the document(s) proposed for IBR, as well as any modifications to an IBR document, and advise CFIA of any related legal considerations, potential limits or risks. CFIA will then determine if it wishes to continue with the next steps to have the regulatory proposal referencing the IBR document(s) published in the Canada Gazette. TB must approve the proposal, which includes the supporting rationale for selecting the IBR document(s) in the RIAS. In addition, the proposal to include an IBR document needs to meet Canada's international obligations.

Once pre-published in the Canada Gazette, Part I, CFIA will notify stakeholders and provide an opportunity to comment on the regulatory proposal that includes the IBR document. CFIA will take the comments received into consideration, as appropriate, before final publication in the Canada Gazette, Part II. The Governor in Council, on the advice of the responsible Minister, makes the final determination of accepting or rejecting the regulatory proposal that includes document(s) incorporated by reference.

For proposed modifications to already incorporated ambulatory documents, the roles and responsibilities depend on the document's administrator. For CFIA-generated documents, CFIA will manage all proposed modifications. Any modification will only be made after thorough assessment, legal input (as noted above), and approval by the appropriate level within CFIA, as established by CFIA guidelines. CFIA will notify domestic and international stakeholders of all proposed modifications to CFIA-generated documents. An opportunity to comment will be provided, unless the proposed modification addresses an immediate risk to health or safety, a minor administrative adjustment or a consequential modification. For external documents, the document's administrator is responsible for proposed modifications. Nevertheless, CFIA will endeavour to work with the responsible party to receive timely notice of any upcoming modifications and communicate them to stakeholders. Where possible, CFIA will direct stakeholders to consultations or comment periods held by the responsible party. Annex B outlines the process for modifying incorporated ambulatory documents.

Depending on the scope of the document incorporated by reference, CFIA branches may share responsibility in the approval, administration, implementation, and enforcement activities related to new and modified documents.

10. References

11. Monitoring and reporting

The Regulatory, Legislative and Economic Affairs Division will review this policy to evaluate its implementation and ability to achieve the stated objectives. This review will help determine if content modifications are required. The review will be conducted on an as-needed basis or at least once every five years.

A review of CFIA's Incorporation by Reference Inventory will be conducted on an as-needed basis or at least annually to check the hyperlinks listed and maintain version control.

12. Inquiries

For clarification or inquiries about this policy please contact:

Director
Regulatory, Legislative and Economic Affairs Division
Policy and Regulatory Affairs Directorate
Policy and Program Branch
cfia.legislation-legislation.acia@inspection.gc.ca

13. Effective date

This second version of the Incorporation by Reference Policy replaces the version dated July 31, 2015 upon the date of its approval noted below.

Approval

This document, Canadian Food Inspection Agency Incorporation by Reference Policy, has been approved by the President of the Canadian Food Inspection Agency.

Siddika Mithani

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Signature

December 4, 2019

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Date

Annex A – Document selection considerations

The following provides a series of factors for consideration, though not exhaustive, that would guide the document selection process for IBR:

  • The document's intended purpose
  • Rationale for ambulatory versus static referenceFootnote 2
  • How often the document may be modified (if ambulatory)
  • Whether or not the document can be clearly referenced in the regulations
  • The degree of clarity conveyed in the regulatory provision if including a partial or qualified reference to a document
  • Whether or not relevant text from the document should be included in the regulation to provide clarification
  • The legal enforceability of the document
  • Standing Joint Committee for the Scrutiny of Regulations concerns (that is, accessibility and legislative authority)
  • Who is responsible for maintaining the document
  • The source and type of existing documents incorporated by reference in the regulations to be amended (if applicable)
  • If the document is consistent with CFIA's mandate
  • The existence of a suitable international document before developing a new Canadian equivalent
  • The international trade implications of incorporating the document
  • How widely accepted the document's content is among interested parties (for example, Canadian public, regulated parties, academia, and international partners)
  • Potential administrative and operational modifications required for regulated parties to comply with the incorporated document
  • The level of clarity in understanding the document's content to ensure stakeholder compliance and offer sufficient support in the event of prosecution
  • The resources and capacity required for CFIA inspectors to perform their duties (such as, possible training)
  • The document's impact on current CFIA programs

The following additional factors should be taken into account when considering the IBR of an external document:

  • The source of the documentFootnote 3
  • The document's availability in both official languages
  • Ability to provide a legitimate justification for selecting a unilingual external document over a bilingual alternative and guidance required per the TB Policy on Regulatory Development (if applicable)
  • Costs associated, if any, with accessing the document and/or copyright issues
  • The scientific, technical and other relevant forms of rigour with which a document was developed
  • The document's relevance to the Canadian context
  • The extent of CFIA's participation in the development and future modifications of the document

Annex B – Process for modifying ambulatory incorporated documents

Internal documents

For ambulatory CFIA-generated documents incorporated by reference, CFIA will adhere to the following process when modifying an existing incorporated document:

1. Review and approvals

CFIA will conduct relevant assessments and consultations (that is, internally and with interested parties) when developing the proposal. In addition, CFIA will determine if a proposed modification would create possible administrative burden to both CFIA and regulated parties. Once a proposal is finalized, it will be reviewed and approved by the appropriate management levelFootnote 4 within CFIA, as established by CFIA guidelines.

2. Domestic and international notification

Once the proposal is approved internally, CFIA will normally notify domestic stakeholders and international trading partners of the proposal and provide them with the opportunity to comment. When the proposed regulatory modification may have an effect on international trade, notification to Canada's trading partners will also be provided. In such cases, CFIA will submit a notification to the World Trade Organization (WTO), in accordance with Canada's international obligations. The duration of the domestic and/or international comment period(s), if applicable, will be specified in the notice. The time will vary depending on the nature of the modification and international and domestic regulatory requirements. Notification may be made public on CFIA's website or through alternative and complementary methods of notification (such as, distribution lists, direct discussions with associations and organizations, etc.).

Note on modifications due to immediate risks to health and safety

Where modifications to an existing incorporated document are required in order to address an immediate risk to health and safety, CFIA may proceed immediately with modifying the document incorporated by reference along with appropriate domestic and international notifications of the modification. If the modification has an effect on international trade, CFIA will notify its trading partners.

Note on minor administrative adjustments

For minor administrative adjustments (for example, correcting spelling or grammar errors), CFIA may proceed immediately with modifying the document incorporated by reference. These adjustments would be limited to those of a "house-keeping" nature that have no impact on health and safety or industry's ability to market their commodities in Canada and internationally.

Note on consequential modifications

For consequential modifications required as a result of new or modified Government of Canada directives or decisions (for example, updating a list or compendium to include products or substances approved by Health Canada), CFIA may proceed immediately with modifying the document incorporated by reference. These modifications would have no known negative impact on health and safety or the industry's ability to market their commodities in Canada and internationally.

3. Analysis of comments

CFIA will review all comments received during the notification period and determine whether any modifications to the proposal are appropriate.

4. Summary of comments

After completing the notification period, CFIA will confirm that the comment period has ended, indicate if comments were received, and provide a non-identifying summary of relevant comments on its website. CFIA will also communicate whether or not it intends to proceed with the proposed modification(s), revise the proposal taking into consideration the comments received, or withdraw the proposal and, if applicable, consider other options. CFIA will provide this information online and notify international partners, as appropriate.

5. Final document modification

Once the notification period has ended and it has been decided to proceed with the modification, CFIA will update the document in both official languages and continue with any required final internal approvals, as established in CFIA guidelines. If significant issues are raised in the comment period that necessitates a change to the document, CFIA will consider returning to #2 above.

Once the documents are approved, CFIA will provide the document's modified version on its website and update its Incorporation by Reference Inventory to provide continued access to the document in force. Hyperlinked documents in guidance will also be updated.

The previous version of the modified document will be archived along with a summary of the modifications. Any modification made to the incorporated document takes effect on the date the modified version is provided on CFIA's website or the date indicated on the document, unless a transition period is applied.

Note on transition periods

A transition period may be provided before a modified incorporated document takes full effect in order to provide domestic and international stakeholders with sufficient time to align their products or practices for compliance purposes. The requirement for and length of any such period will be determined on a case-by-case basis and/or based on any applicable legislative, regulatory or other formal requirements (for example, international arrangements). The domestic and WTO notifications will specify if there is a transition period.

External documents

When CFIA is aware that an OGD or third party intends to modify an existing incorporated document, CFIA will adhere to the following process:

1. Domestic and international notification

When an OGD or third party proposes modifying an incorporated document, CFIA will notify domestic stakeholders and international partners. CFIA will also provide information on how to access the proposal and any relevant comment platform, where applicable. The duration of the comment period, if any, will be specified in the notice based on the OGD or third party's determination. For domestic stakeholders, this notification will be provided via CFIA's website and existing email distribution lists (such as, e-mail notification). International partners will receive notification through the WTO notification process.

2. Analysis of comments

Where possible, CFIA will endeavour to work with the OGD or third party in order to ensure that the anticipated modification does not conflict with CFIA's mandate to safeguard Canada's food animals, and plants or with Canada's international obligations. This includes requesting justification for the modification, its anticipated timeline, and access to comments received or summary documents produced.

3. Summary of comments (if applicable)

Once the OGD or third party has concluded its comment period, CFIA will provide a link on its website to direct stakeholders to any reports issued, if applicable, that summarize the comments received. If the final version of the proposed modification is not consistent with CFIA's policy objective, CFIA may consider and adopt a number of alternative approaches, such as proposing a regulatory amendment that would achieve one of the following:

  1. replace the ambulatory reference with a static reference to the earlier version of the document
  2. introduce a qualified reference that excludes specified portions of the document deemed unsuitable
  3. include reference to a more suitable external document or internally generate a new document
  4. repeal the reference entirely and pursue appropriate legislative, policy or administrative avenues

4. Final document modification

Where the modified document meets CFIA's policy objective, CFIA will update its Incorporation by Reference Inventory, where necessary, once CFIA is made aware that the OGD or third party made the new version of its document available publically. Hyperlinked documents in guidance will also be updated. This will provide continued access to the applicable document. Previous versions will be archived online along with a summary of the modifications, when feasible.

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