Health Canada Incorporation by Reference Policy

On this page

1. Introduction
2. Scope
3. Definitions
4. Authorities
5. Roles and Responsibilities
6. Guiding Principles
7. Incorporation by Reference of a Document into Regulation
8. Amending Documents Incorporated by Reference
9. Monitoring and Reviewing
10. References
11. Departmental Contact Information
12. Effective Date

1. Introduction

"Incorporation by Reference" is a term used to describe a mechanism, which allows a document or list that is not in the text of the regulations to be made a part of the regulations. Health Canada uses incorporation by reference to achieve policy and regulatory objectives.

Incorporation by reference enables Health Canada to leverage existing documents and maintain agile regulatory frameworks that can more quickly adapt to changes in science or technology, or in response to an emerging health or safety risk. Incorporation by reference can also contribute to items such as regulatory alignment with the provinces and territories and to international cooperation on matters of trade^{Footnote 1}, without compromising health and safety.

The purpose of this policy is to set out Health Canada's framework for the identification, development and management of documents incorporated by reference into the regulations that Health Canada administers.

The objectives of this policy are to:

• Describe the sources of authority for incorporation by reference into the regulations that Health Canada administers;
• Specify Health Canada's roles and responsibilities related to documents incorporated by reference into the regulations that Health Canada administers;
• Set out the general principles that guide the selection of documents incorporated by reference to encourage department-wide uniformity in the use of incorporation by reference; and
• Outline a process for document modification.

This policy builds on the foundation provided by the Cabinet Directive on Regulation and the Treasury Board of Canada Secretariat's Policy on Regulatory Development, which states that incorporation by reference can be an effective tool in achieving regulatory outcomes. Those policies also encourage government departments to consider incorporation by reference, and to identify and manage risks associated with doing so.

2. Scope

This policy applies to all documents incorporated by reference into regulations that Health Canada administers, whether or not the documents are developed and maintained by Health Canada or by a third party.

3. Definitions

Incorporation by reference of a document

Is a mechanism that introduces the content of a document (such as a directive, list, or standard), in whole or in part, into a regulation without having to reproduce the document's text in the regulation. If a document is incorporated by reference, the incorporated wording has the same effect as if it appeared in the regulation and is legally binding.

Static incorporation

Refers to the incorporation by reference of a document into a regulation, as it exists on a particular date. Static references to a document normally include its publication date or phrases such as "published on" or "issued on" or "as of [a date]" in the regulatory text. Any changes to the document would not take effect in the regulations, unless the regulations are amended through the usual regulatory process to reference the newer version. In the absence of such a regulatory change, the originally referenced version remains in force for the purposes of the regulations.

Ambulatory incorporation

Refers to the incorporation of a document into a regulation, as it is changed over time. Ambulatory references to a document normally include phrases such as "as amended from time to time" or "the latest edition of (document)" in the regulatory text. Any change to the document would immediately become part of the regulation or law without going through the entire regulatory process. Unlike static references, ambulatory references do not have to mention a specific version or date of issue of the document.

Health Canada's Inventory of Documents Incorporated by Reference

Is a list of all documents incorporated by reference into regulations that Health Canada administers. This inventory will be available on Health Canada's website alongside this policy, accessible from the Health Canada Acts and Regulations webpage and will provide hyperlinks to the incorporated documents themselves or information regarding where to obtain the incorporated documents.

4. Authorities

The Statutory Instruments Act (sections 18.1 through 18.7) provides the authority to incorporate by reference a document or part of a document in regulations, including ministerial regulations, as it exists on a particular date or as it is amended from time to time. It imposes an obligation on regulatory authorities to ensure that a document incorporated by reference is accessible. It applies where the Act under which the regulations are made does not expressly confer a power to incorporate by reference.

In addition to this authority, many statutes administered by Health Canada specifically grant authority to incorporate by reference a document under certain conditions. The Acts that Health Canada administers that provide a specific authority to incorporate documents by reference in regulation include:

• Assisted Human Reproduction Act (ss. 65(2))
• Canada Consumer Product Safety Act (ss. 37(2) – (7))
• Canadian Environmental Protection Act, 1999 (ss. 330(2))
• Cannabis Act (ss. 139(8))
• Controlled Drugs and Substances Act (ss. 55(3))
• Food and Drugs Act (s. 29.2 and s.30.5)
• Hazardous Products Act (ss. 15(3) – (9))
• Pest Control Products Act (ss. 67(2) – (2.3))
• Tobacco and Vaping Products Act (s. 42.5) 

The Statutory Instruments Act limits documents produced by a regulator to incorporating a static reference, unless specific authority is provided under the regulatory statute. The Assisted Human Reproduction Act, the Canada Consumer Product Safety Act, the Cannabis Act, the Controlled Drugs and Substances Act, the Food and Drugs Act, the Pest Control Products Act and the Tobacco and Vaping Products Act include a broader authority that allows for the ambulatory incorporation by reference of documents in regulations created by the department.

5. Roles and Responsibilities

Health Canada's responsibilities in relation to incorporation by reference include:

1. Developing Health Canada documents for incorporation by reference;
2. Contributing to the development of third-party documents to be incorporated by reference where possible, in collaboration with the organization developing the document;
3. Incorporating documents by reference into regulation according to the regulatory development process;
4. Facilitating access of the document incorporated by reference;
5. Administering modifications made to Health Canada documents incorporated by reference;
6. Reviewing modifications made by third parties;
7. Monitoring of the incorporated document to verify that it continues to contribute to the policy and regulatory objectives; and
8. Managing the Inventory of Documents Incorporated by Reference.

Note that, as part of the regulatory process, the Department of Justice reviews the document(s) proposed for incorporation by reference, as well as their modification, and advises Health Canada of any potential limits, risks or other related legal considerations.

6. Guiding Principles

As documents incorporated by reference are developed, reviewed and maintained, Health Canada relies on the principles of transparency, reasonableness, consistency in the decision-making process, and clarity and accessibility of content and their alignment with the rule of law.

6.1 Transparency

As set out in the Cabinet Directive on Regulation, the Regulatory Impact Analysis Statement for a regulatory proposal explains why incorporation by reference is being used and how it achieves its policy and regulatory objectives. A rationale for ambulatory versus static reference in regulation is also provided in the Regulatory Impact Analysis Statement.

As a best practice, a document developed by Health Canada to be incorporated by reference into regulation is developed, reviewed and maintained in an open and transparent way that meaningfully engages stakeholders. Health Canada seeks to ensure that similar principles and processes are followed with documents from third parties that are incorporated by reference.

6.2 Reasonableness

Health Canada adopts a reasonable approach for the use of incorporation by reference. A document may be incorporated by reference if there is a need or benefit from doing so in light of practical considerations and alternative approaches. A reasonable approach can include flexibility to incorporate efficient practices used by industry or reflect the latest scientific evidence.

6.3 Consistency

Health Canada, to the extent practicable, follows a consistent process (see section 7 below) when using incorporation by reference, for modifying internal documents incorporated on an ambulatory basis, and for reviewing changes to third-party documents.

6.4 Clarity

Documents produced by Health Canada must be clear and easily understood by the targeted regulated party. For third-party documents, Health Canada supports its stakeholders by providing guidance regarding interpretation and clarity, as needed.

6.5 Accessibility

Ensuring the accessibility of documents incorporated by reference is an important rule-of-law-based principle and is codified in a number of laws, including subsection 18.3(1) of the Statutory Instruments Act. In practice, it means that the incorporated document can be easily found with a reasonable amount of effort and at a reasonable cost.

Consistent with Canada's Official Languages Act, all Health Canada-generated documents must be available in both English and French, including documents incorporated by reference. Unilingual third-party documents may be incorporated by reference when there is a legitimate reason to do so. Health Canada provides guidance in both official languages in circumstances where no equivalent document exists in both official languages (see Treasury Board of Canada Secretariat's Policy on Regulatory Development and the Official Languages Act).

When feasible, previous versions of Health Canada-generated documents incorporated by reference will be available on Health Canada's website. When the documents cannot be made available on Health Canada's website they will be provided upon request, so that stakeholders can have access to the content of the document at specific points in time.

The Reproduction of Federal Law Order (1997) (Order) allows regulations and other statutory instruments to be reproduced, with some restrictions. However, this Order may not apply to a document incorporated by reference in a regulation, such as a standard developed by a third-party that has copyright protections. The standards development organization or other organization that publishes the document typically holds copyright, so that the document may not be reproduced or distributed without appropriate permissions, even though it has been incorporated into a regulation. The organization may charge a fee to access the document. In some cases, a document may be available without any cost for “view-only” or “read-only” access. Health Canada may also provide information, in both official languages, to reduce the risk of confusion or uncertainty with respect to documents incorporated by reference for which there is a cost to assess (see Treasury Board of Canada Secretariat's Policy on Regulatory Development).

7. Incorporation by Reference of a Document into Regulation

Following the guiding principles provided in section 6 above, Health Canada develops, reviews and publishes documents or identifies third-party documents that will be incorporated by reference as part of regulations.

When Health Canada incorporates by reference a document into regulation, the following is taken into consideration:

• The authority under which the incorporation by reference may be made;
• Whether the incorporation is static or ambulatory, and an accompanying rationale;
• Whether the document is a Health Canada publication or a third-party document; and
• All international treaty obligations with respect to trade.

7.1 Incorporation by reference of Health Canada documents

The incorporation by reference of a Health Canada document into regulations involves:

• Providing a rationale in the Regulatory Impact Analysis Statement;
• Publishing versions of the document in both official languages;
• A review by the Department of Justice, which includes reviewing international obligations; and
• Notifying and consulting, in most cases, the public and stakeholders.

7.2 Incorporation by reference of third-party documents

The authors of third-party documents manage the development and maintenance of their documents. Prior to the incorporation by reference of these documents, Health Canada considers the following:

• The document's intended purpose;
• The scientific and technical rigour, when applicable, with which the third-party document was developed;
• The relevance of the third-party document to the Canadian context;
• How often the document may be revised;
• The accessibility of previous versions;
• The process by which the document is revised;
• The extent of Health Canada's participation and involvement in revisions to the document;
• Whether the third party develops and publishes the document in both English and French; and
• Whether the document is subject to copyright.

7.3 Consultation

In general, Health Canada manages consultations with stakeholders regarding the proposed incorporation by reference through its engagement mechanisms, such as the website, technical briefings, meetings, targeted communications, and webinars. Each program consults, as appropriate, via their established methods.

When Health Canada develops a document to be incorporated by reference into regulation or proposes to incorporate by reference a third-party document into regulation, it notifies stakeholders and gives them the opportunity to share their comments or concerns on the proposed incorporation by reference document.

Typically, stakeholders are notified by Health Canada prior to and/or through the pre-publication of the proposed regulation in the Canada Gazette, Part I. In the case of a document proposed for incorporation by reference through a ministerial regulation (e.g. a food marketing authorization, or an advanced therapeutic product license or order of permission), stakeholders are typically notified through a Notice of Intent (NOI) process.

In cases where there is a serious and immediate risk to the health and safety of Canadians, it should be noted that a consultation with stakeholders may not take place before the regulation is put in place.

A document that is incorporated by reference in a regulation is not required to be transmitted for registration or published in the Canada Gazette^{Footnote 2}.

8. Amending Documents Incorporated by Reference

Documents incorporated by reference may periodically require amending for a number of reasons. Changes that are administrative in nature include changes that do not impact policy or the technical requirements outlined in the document incorporated by reference. They can also include consequential changes resulting from an amendment to the statute or regulations.

Significant changes are those that impact policy or compliance requirements and result in substantive change(s) to the document incorporated by reference. Significant changes may also be urgent in nature, such as to address an immediate risk to human health and safety (e.g., emerging disease).

In the case of a document incorporated by reference on a static basis, a regulatory amendment is always required to change the reference found in the regulations. Health Canada follows the regulatory amendment process to incorporate the “new” reference.

The management of a document incorporated by reference on an ambulatory basis is done administratively. Ambulatory documents incorporated by reference can be changed for various reasons, including in response to new science, an emerging health risk, technical or administrative updates, or feedback from stakeholders, including international partners.

Regulatory amendments are not required, and any change to an incorporated ambulatory document becomes part of the regulation or law. Health Canada notifies stakeholders and consults, when appropriate, on any changes to documents incorporated by reference on an ambulatory basis.

In the case of international third parties, Health Canada may work with Global Affairs Canada to better understand Health Canada's responsibilities in the notification and consultation processes when there is a change to an international third-party document incorporated by reference into a Canadian regulation.

8.1 Amending third-party documents

Health Canada works with third parties whose documents are incorporated by reference in regulations to receive timely notice of any upcoming changes and communicate them to stakeholders, in most cases.

Health Canada informs and directs stakeholders to consultations or comment periods held by the responsible party for the third-party document, when feasible and appropriate. Depending on the scope of the third-party document incorporated by reference, Health Canada may share responsibility with the third party for the approval, administration, and implementation related to the document. However, Health Canada is always responsible for the interpretation of the third-party document incorporated by reference in the regulation.

8.2 Amending Health Canada documents

8.2.1 Proposal for change

Health Canada regularly monitors emerging health and safety risks, as well as scientific and technological advances, to verify that the content of a document incorporated by reference continues to be appropriate and effective for the policy or regulatory objective, such as reducing the risks to human health and safety, and will modify the document, if required. In addition, stakeholders may identify significant advances in industry practices, science, or technology, which may lead Health Canada to review and update an incorporated document.

When it is determined that an amendment is needed, Health Canada reviews the evidence and will leverage internal and/or external subject matter experts, as needed, to draft a proposed amendment to the document incorporated by reference. This may include consulting other government departments, as needed, to identify and account for potential consequential impacts of the proposed amendment on other regulations or policies.

Health Canada may also consider additional factors such as industry best practices, administrative burden on industry, and international alignment of the requirements with other jurisdictions when making changes. If necessary, Health Canada may seek a review of the proposed amended document by the Department of Justice to verify that changes align with the purpose of the regulations and are within the scope of Health Canada's objectives and incorporation by reference authorities, and respect the rule of law.

8.2.2 Consultation

As a best practice, Health Canada notifies stakeholders of any significant amendments to a document incorporated by reference and provides opportunity to comment on the proposal.

An exception occurs when addressing an immediate risk to human health or safety, in which case, Health Canada may amend the document without consulting stakeholders prior to making the change. Alternatively, depending on the nature and scope of the urgent amendment, Health Canada may decide to consult a targeted group of relevant stakeholders (e.g., subject matter/industry experts or those significantly impacted by the proposed amendment) or consult more broadly and provide a shorter comment period than would typically be provided for a significant amendment to the document. Finally, Health Canada may elect to make the urgent amendments to the document first to mitigate the immediate risk and then consult stakeholders, making further changes as deemed necessary after the consultation.

For administrative amendments that have no impact on the requirements outlined in this document, Health Canada does not consult and proceeds with the required amendments. Regardless of the type of amendment (i.e., administrative or significant), stakeholders are notified every time a document is substantially amended.

8.2.3 Analysis of comments

When consultations are held, Health Canada will review and document the comments received from stakeholders during the consultation period and determine if any changes to the proposed amendment are warranted based on the totality of relevant evidence. Health Canada may provide a summary of comments to the stakeholders that participated in the consultations. Health Canada will also communicate whether or not it intends to proceed with the proposed amendment(s), revise the proposal taking into consideration the comments received, or withdraw the proposal and, if applicable, consider other options. Health Canada may also consider further consultation, if serious issues are raised that necessitate a significant revision to the proposed amendment.

8.2.4. Finalizing an amended document incorporated by reference

Once consultations are concluded and it has been determined that the best course of action is to proceed with a change to the document, Health Canada updates the document in both official languages and notifies stakeholders of the changes and where to find the updated document.

Health Canada will continue to review and consider post-implementation feedback and restart the process to amend the document incorporated by reference as needed.

9. Monitoring and Reviewing

9.1 Documents Incorporated by Reference

Health Canada monitors and reviews documents incorporated by reference into the regulations that it administers and verifies that the material continues to meet the stated policy and regulatory objectives (Treasury Board of Canada Secretariat's Policy on Regulatory Development, section 7.1.4).

9.2 Inventory of Documents Incorporated by Reference

Health Canada's Inventory of Documents Incorporated by Reference is an online list of documents incorporated by reference in the regulations that Health Canada administers. Health Canada will review this inventory on an as-needed basis and at least annually, to ensure that the list remains valid and up-to-date, including a verification of website links.

9.3 Incorporation by Reference Policy

Health Canada will review this policy to evaluate its implementation and ability to achieve the stated objectives on an as-needed basis or once every five years. Revisions to the Cabinet Directive on Regulation or Treasury Board of Canada Secretariat's policies may also trigger a need to review.

10. References

• Cabinet Directive on Regulation
• Reproduction of Federal Law Order (1997)
• Statutory Instruments Act
• Treasury Board of Canada Secretariat's Policy on Regulatory Development

11. Departmental Contact Information

For information on the Health Canada Incorporation by Reference Policy and Inventory of Documents Incorporated by Reference, contact Health Canada's Departmental Regulatory Affairs Section at dra-arm@hc-sc.gc.ca.

12. Effective Date

This Incorporation by Reference Policy takes effect on December 21, 2021.