Guide to the Federal Regulatory Development Process

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About this Guide

Regulation is a key instrument used by the Government of Canada to achieve various policy objectives and improve the quality of life of Canadians. It is an important tool for protecting the health and safety of Canadians, the environment, and for securing the conditions for an innovative and prosperous economy.

Given the impact that regulations can have on Canadians and our economy, the federal regulatory process is highly structured. It is defined both by specific legal requirements set out in the Statutory Instruments Act and by policy requirements that are articulated in the Cabinet Directive on Streamlining Regulation (CDRM). Recognizing that the regulatory process can be complex, the Treasury Board of Canada Secretariat has developed a series of frameworks and documents to assist regulatory organizations.

This Guide to the Federal Regulatory Development Process is one of these tools. It is intended for use by public service employees who are working in Canadian federal departments, agencies, and Crown corporations and who are involved in developing regulations or otherwise implementing the Cabinet Directive on Streamlining Regulation.

Additional information and guidance documents on the federal regulatory process can be found at http:/www.regulation.gc.ca. The following address, email, and telephone numbers may also be useful:

Email: [[1]]

Telephone: 613-957-2400

Toll-free: 1-877-636-0656

TTY: 613-957-9090

Fax: 613-943-5071


Postal Address

Regulatory Affairs Sector

Treasury Board of Canada Secretariat

155 Queen Street, Suite 1100

Ottawa ON   K1A 0R5

Part 1: Regulations as a Policy Instrument

In Canada, regulations are made by persons or bodies, such as the Governor in Council (GIC), a minister, or an administrative agency, to whom Parliament has delegated its authority in an act. Regulations are a form of law–they have binding legal effect and usually set out general rules rather than specific ones that are directed toward persons or situations.

The process described herein assumes that officials have evaluated the range of instruments available to them for achieving a given policy objective and have determined that regulation is a necessary part of the instrument mix. Departments and agencies are responsible for assessing the effectiveness and appropriateness of regulatory and non-regulatory instruments for achieving policy objectives. The Treasury Board of Canada Secretariat's Regulatory Affairs Sector (TBS-RAS) has produced a guide, Assessing, Selecting, and Implementing Instruments for Government Action, which provides guidance on instrument choice before proceeding with a regulatory proposal.

Cabinet Directive on Streamlining Regulation

The Cabinet Directive on Streamlining Regulation came into effect on April 1, 2007, replacing the previous Government of Canada Regulatory Policy. The CDRM sets out guidance on the federal regulatory process (the legal requirements of the process are described in the Statutory Instruments Act). It applies to all departments and agencies involved in the federal regulatory process. Government officials are responsible for abiding by the CDRM at all stages of the regulatory life cycle, i.e., development, implementation, evaluation, and review.

The CDRM marks a fundamental change in approach to federal regulation. It stresses that regulations are only one of several policy instruments available to government and that they may not always be the most effective option. When a public policy issue arises and it is determined that government intervention is required, regulatory organizations must assess the effectiveness and appropriateness of both regulatory and non-regulatory instruments before proceeding. Regulations must be viewed not in isolation but rather as part of a mix of complementary instruments that work together to address a public policy issue. They should be chosen only after the full range of instruments has been analyzed.

What Is a Regulation?

A regulation is one of the many instruments that government uses to achieve policy objectives and improve the quality of life of Canadians.

A regulation, in its broadest sense, sets out principles, rules, or conditions that govern the behaviour of citizens and organizations. Governments use regulations in combination with other instruments to achieve public policy objectives. Regulations are a form of law–they have force of law and usually set out general rules and penalties rather than specific ones that are directed toward persons or situations.

Regulating is an extension of the power given to Parliament by the Constitution to make laws. It is through a delegation of authority from Parliament in an act–known as an "enabling authority"–that the Governor in Council (the Governor General, acting on the advice of the federal Cabinet), the Treasury Board, a minister, or another administrative agency is given the authority to make regulations. The regulation is thus referred to as "delegated" or "subordinate" legislation. Authority to make regulations must be expressly provided for in the enabling legislation. Regulations must be consistent with all provisions of the enabling act.

The Statutory Instruments Act provides a specific definition of the term "regulation." The Drafting and Advisory Services Group of the Department of Justice (JUS)–commonly referred to as the JUS Legislative Counsel–is responsible for ensuring that a proposed regulation is consistent with that definition. If you have questions on this matter, contact either the Headquarters Regulations Section at 613-957-0087 or one of the following departmental regulations sections of the Drafting and Advisory Services Group:

National Defence Regulations Section: 613-995-2653

Environment Canada Regulations Section: 819-994-6346

Health Canada Regulations Section: 613-952-9645

Transport Canada Regulations Section: 613-993-1956

The CDRM builds on the previous regulatory policy and identifies the following key principles:

  • Protect and advance the public interest in health, safety and security, the quality of the environment, and the social and economic well-being of Canadians, as expressed by Parliament in legislation;
  • Promote a fair and competitive market economy that encourages entrepreneurship, investment, and innovation;
  • Make decisions based on evidence and the best available knowledge and science in Canada and worldwide, while recognizing that the application of precaution may be necessary when there is an absence of full scientific certainty and a risk of serious or irreversible harm;
  • Create accessible, understandable, and responsive regulation through inclusiveness, transparency, accountability, and public scrutiny;
  • Advance the efficiency and effectiveness of regulation by ascertaining that the benefits of regulation justify the costs, by focussing human and financial resources where they can do the most good, and by demonstrating tangible results for Canadians; and
  • Require timeliness, policy coherence, and minimal duplication throughout the regulatory process by consulting, coordinating, and cooperating across the federal government, with other governments in Canada and abroad, and with businesses and Canadians.

The CDRM provides guidance on managing the implementation of regulations, evaluating their performance, and reviewing regulatory frameworks. To that end, the CDRM introduces a life-cycle approach to regulation, with specific requirements for all stages of the life cycle. This approach requires that regulations continually meet their policy objectives and be evaluated and renewed on an ongoing basis, thus ensuring a more effective, efficient, and accountable regulatory system. The success of the regulatory product depends on each stage not being seen as a separate activity, but as part of a continuous feedback loop.

Forward Planning

In support of this approach to regulation, the Treasury Board of Canada Secretariat (the Secretariat) has a reporting requirement and form entitled the "Forward Plan" (a sample page is provided in the Appendix). The purpose of this plan is to:

  • Identify GIC proposals (both regulatory and non-regulatory Orders in Council) that will be presented to the Treasury Board Cabinet Committee for consideration in the coming parliamentary session;
  • Situate these initiatives within the broader governmental agenda;
  • Identify linkages with other initiatives under way or planned; and
  • Demonstrate how these initiatives support the objectives of the CDRM.

Forward plans enable the Secretariat to anticipate proposals and work more closely with regulatory organizations to ensure that strategies are in place to address issues that might otherwise delay consideration of time-sensitive proposals (e.g., those that would require a policy discussion or funding decisions by Cabinet).

Types of Regulation

Federal regulations are often categorized in the following classes:

  • GIC regulations: The enabling act gives the GIC the authority to make regulations on specific matters. These are the most common type of regulations and follow the process described in Part 2 of this guide.
  • Ministerial regulations: The enabling act gives a minister or the head of an agency the authority to make regulations. This guide does not apply to such regulations.

Key Players in the Regulatory Development Process

The federal regulatory development process involves a number of players, each of which has distinct roles and responsibilities:

  • Regulatory organizations: Certain federal departments and agencies, Crown corporations, commissions, and other bodies may be authorized by an act of Parliament to develop and propose, through their ministers or agency heads, regulations in specified areas of public policy. Regulatory organizations can also be responsible for implementing regulations.
  • Treasury Board: The Treasury Board is a committee of Cabinet ministers that provides advice to the Governor General on the regulatory proposals of the government, among other matters. The Treasury Board is chaired by the President of the Treasury Board.
  • Governor in Council: GIC appointments are made by the Governor General, on the advice of the Queen's Privy Council of Canada (for regulations, represented by Treasury Board ministers). Parliament may, through legislation, delegate responsibilities and duties to the GIC, including the making of most federal regulations.
  • The Regulatory Affairs Sector of the Treasury Board of Canada Secretariat: TBS-RAS is responsible for ensuring that the analysis provided by departments and agencies on policy and regulatory proposals is consistent with the commitments and directions set out in the CDRM and that the analysis effectively supports ministerial and Cabinet decision making. TBS-RAS is also responsible for promoting policy coherence among new proposals, existing policies, and the government's policy agenda.
  • Department of Justice Canada (JUS): The JUS Legislative Counsel examines proposed regulations in accordance with the Statutory Instruments Act. The Counsel works together with jurilinguists, bijurists, and revisors to prepare regulations on behalf of regulatory organizations. JUS also explains the legislative and regulatory process; provides legal opinions on the extent of the authority under which regulations are made and determines whether documents are subject to the regulatory process; ensures that proposed regulations are consistent with government policies and international obligations; and forms a partnership with clients for all communications with the Standing Joint Committee for the Scrutiny of Regulations dealing with legal and drafting issues.
  • Privy Council Office: As set out in the Statutory Instruments Act, the Clerk of the Privy Council Office (PCO), through the Orders in Council Division of the Privy Council Office (PCO-OIC), is responsible for receiving GIC regulatory submissions in both official languages from regulatory organizations, examining the proposal in consultation with the deputy minister of JUS, advising the regulation-making authority (currently the Treasury Board Cabinet Committee) that the proposed regulation has been so examined, and registering regulations after they are made by the GIC or made by another regulation-making authority.
  • Public Works and Government Services Canada (PWGSC): PWGSC publishes the Canada Gazette, the official newspaper of the Government of Canada. Proposed regulations and supporting documentation are published in Part I of the Canada Gazette, while regulations that have been made are published in Part II. Part III of the Canada Gazette contains acts of Parliament after they have received royal assent, as well as a list of the Proclamations of Canada and Orders in Council (OIC) relating to the coming into force of federal acts. Electronic (PDF) versions of the acts and regulations are now considered legal official texts.
  • Standing Joint Committee for the Scrutiny of Regulations: The Committee's mandate is defined by the Statutory Instruments Act, the Legislation Revision and Consolidation Act, and the Standing Orders of the House of Commons. Pursuant to the Statutory Instruments Act, the Committee can scrutinize any statutory instrument made after December 31, 1971. The Statute Revision Act authorizes the Committee to scrutinize any regulation found in the 1978 Consolidated Regulations of Canada or revised Regulations prepared pursuant to that Act, even if that regulation were made prior to the coming into force of the Statutory Instruments Act in 1972. The Standing Orders of the House of Commons expand on the mandates found in these two acts by authorizing the Committee to examine any other matter referred to it by both houses of Parliament.

Part 2: Overview of the Federal Regulatory Development Process

The federal regulatory development process is structured so as to provide a consistent approach to making regulations across government while ensuring that the policy commitments and legal obligations of the Government of Canada are met. A structured process also ensures predictability for Canadians, institutions, and businesses affected by regulation.

Getting Started

The Cabinet Committee Operations Division, TBS-RAS, is responsible for working with and providing guidance to regulatory organizations throughout the regulatory development process. Each analyst is responsible for a specific portfolio of departments and agencies. TBS-RAS also has a Policy Division that interprets the CDRM and assists regulators by developing and publishing in-depth guides on regulatory analysis.

You should involve your TBS-RAS analyst early in the development of a regulatory proposal, preferably as soon as a decision has been made to regulate. This may be done in one of the three following ways:

  • If your department or agency has a regulatory coordinator, advise this person of your regulatory initiative and ask him or her to arrange a meeting or put you in contact with the appropriate TBS-RAS portfolio analyst.
  • If your department or agency does not have a regulatory coordinator, contact your TBS-RAS portfolio analyst directly.
  • If you do not know the name of your TBS-RAS analyst, call 613-943-5076 or contact TBS for assistance.

Steps in the Regulatory Development Process

The checklist below outlines the steps involved in the approval process for GIC regulations. The process has been designed to help ensure that the requirements of the Statutory Instruments Act and the CDRM are complied with. Details on each step are provided in the following pages. In accordance with the CDRM, regulatory organizations are expected to consult Canadians and stakeholders at all stages of the regulatory process.

A. Seeking Pre-Publication of a Proposed Regulation
Step Description Who Is Involved Approvals
1 Determine the level of impact (triage) and whether an exemption from pre-publication will be sought. See the Exemption from Pre-Publication section for more information. Regulatory Organization (RO) and TBS-RAS RO director or above signs finalized triage
2 Conduct analysis and develop the Regulatory Impact Analysis Statement (RIAS), and obtain concurrence on the RIAS from TBS-RAS analyst. RO and TBS-RAS
3 Draft the regulation. RO and JUS RO director general
4 Examine draft regulation and review the RIAS (the extent of the RIAS review varies according to the mandate of the Regulations Section involved) and issue stamped copies of the draft regulation. JUS
5 Send signed regulatory submission to PCO-OIC. RO and PCO-OIC Responsible minister signs proposal
6 Treasury Board considers the submission and decides whether to approve it for pre-publication. Treasury Board, TBS-RAS, and PCO-OIC Treasury Board approves pre-publication
7 Pre-publish the proposed regulation in the Canada Gazette, Part I. PCO-OIC and PWGSC
B. Seeking Final Approval, Publication, and Registration of a Proposed Regulation
Step Description Who Is Involved Approvals
8 Receive and review comments on the draft regulation, revise the regulation, update the RIAS, as needed and obtain concurrence on it from TBS-RAS analyst. RO and TBS-RAS
9 Examine the proposed regulation and RIAS and issue stamped copies. JUS
10 Send signed final regulatory submission to PCO-OIC. RO and PCO-OIC Responsible minister signs proposal
11 The GIC (Treasury Board ministers advising the Governor General) considers the submission and decides whether to make the regulation. Treasury Board, Governor General, TBS-RAS, and PCO-OIC GIC makes regulation
12 Register and publish regulations in the Canada Gazette, Part II. PCO-OIC and PWGSC
13 Review by the Standing Joint Committee for the Scrutiny of Regulations.

C.    Ongoing Performance Measurement and Evaluation of Regulatory Activities

A period of 6 to 24 months should be reasonable to allow the completion of the approval process for a GIC regulatory proposal, from the time the triage process begins to the regulation becoming law. Establish some timelines at the inception of the project and discuss their feasibility with your TBS-RAS analyst in consultation with JUS. A proposed timeline format (critical path) is provided in Part 3 of this guide.

Seeking Approval for Pre-Publication

Step 1: The Triage Statement

The first step in the regulatory development process is to assess the level of impact of the regulatory proposal, determine whether an exemption from pre-publication will be requested, prepare a Triage Statement, and have the statement approved by your TBS-RAS analyst. This meets the CDRM requirement for regulatory proposals to be assessed at an early stage to determine where approval processes can be streamlined and where resources should be focussed.

Submit a draft of the completed Triage Statement to your TBS-RAS analyst for review and discussion. Together, you and your analyst need to determine the level of impact of the proposed regulation, which allows time and resources to be focussed where they are most needed–on medium- and high-impact proposals.

It is also at this stage that the potential impact of a proposal on international trade will be determined. In cases where a regulating organization cannot adequately assess its pre-publication requirements in terms of international trade obligations (i.e., whether a 75-day pre-publication period is required), you are to consult with your TBS-RAS analyst, who will determine the proper course of action. TBS-RAS will consult with the Department of Foreign Affairs and International Trade as required.

Once the Triage Statement has been finalized, submit two original copies signed by the director responsible for the proposal to TBS-RAS for co-signature. One copy will then be returned to the sponsoring regulatory organization. The Triage Statement should be finalized and co-signed by the regulatory organization and TBS-RAS before proceeding to Step 2, as it will impact the level of analysis and consultation required and the format of the Regulatory Impact Analysis Statement (RIAS). A copy of the finalized triage should also be provided to the JUS Legislative Counsel when the regulatory proposal or list of regulatory drafting instructions is submitted to JUS for examination and, where relevant, drafting.

Additional information and guidance on completing the Triage Statement is provided in the Triage Statement Guide. At this stage, your TBS-RAS analyst can also provide advice and assistance as well as consider requests for exemptions from pre-publication.

HINT: Forming a team to develop and implement a PMEP has been found to be an effective practice. The team should include not only regulatory development officers, evaluators, and corporate officers but also cost-benefit analysis experts, risk assessors and managers, IM/IT personnel, Secretariat analysts, and compliance promotion, enforcement, and monitoring groups, among others.

Exemption from Pre-Publication

The policy of pre-publishing regulatory proposals in the Canada Gazette, Part I, is intended to promote transparency and effectiveness by offering a final comment period before regulations are considered by Treasury Board ministers for approval by the GIC. In some cases, proposed regulations must be pre-published due to statutory requirements. However, there are circumstances under which proposed regulations may be exempted from pre-publication. Examples include (but are not limited to) the following:

  • Regulations that are exempted from publication pursuant to section 15 of the Statutory Instruments Regulations;
  • Regulations that are exempt from pre-publication pursuant to the enabling act;
  • Some regulations that are determined to be of low impact based on the completed Triage Statement;
  • Regulations that respond to emergencies that pose major risks to health, safety, the environment, or security;
  • Sensitive regulations for which pre-publication would cause demonstrable adverse effects or undermine the intent of the regulations, such as those affecting subsidy changes and interest rate changes;
  • Miscellaneous amendments regulations, such as renumbering, bringing corrections to ensure consistency between English and French versions, or bringing corrections of grammatical or typographical errors; and
  • Repetitive regulations that are regularly duplicated in the same form (e.g., the Energy Supply Allocation Board Regulations, which must be amended every two years to name board members).

TBS-RAS advises departments and agencies on the appropriateness of a proposed exemption from pre-publication and makes a recommendation to Treasury Board ministers. Treasury Board ministers consider requests for exemption on a case-by-case basis. No exemption from pre-publication is available if there is a statutory requirement to pre-publish.

Any request for exemption from pre-publication should be discussed with your TBS-RAS analyst prior to completing the drafting of a regulation. Where such an exemption is provided for in the proposed regulation, the JUS Legislative Counsel will not stamp the regulation for Part II of the Canada Gazette until TBS-RAS confirms in writing that it supports an exemption from pre-publication.

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