Guide to the Federal Regulatory Development Process

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: info@tbs-sct.gc.ca

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.

Centre of Regulatory Expertise

The CDRM introduces a life-cycle approach to regulatory management and a number of new process, coordination, and analytical requirements. Recognizing that it may take a number of years for regulatory organizations to fully develop the internal capacity to meet these requirements, the Secretariat has created the Centre of Regulatory Expertise (CORE) to assist in this endeavour.
CORE provides expert advice and services to help departments build their internal capacity to develop sound, evidence-based regulatory proposals. CORE experts offer the following guidance:

Analytical services to support regulatory development work, especially in areas of risk assessment, cost-benefit analysis, performance measurement, and evaluation plans;

Coaching and advisory services to assess progress in regulatory development and provide ongoing feedback and advice;

Workshops and presentations on one or more aspects of regulatory development, tailored to your team's needs; and

Peer review to critique and provide feedback on completed analyses before finalizing a regulatory submission.

CORE also collaborates with the Community of Federal Regulators and the Canada School of Public Service (CSPS) to develop and promote best practices and learning opportunities for federal regulators. For example, a core curriculum of regulatory training has been developed by CSPS to provide participants with a basic understanding of the federal regulatory process, the regulatory life-cycle approach, and the changes occurring under the CDRM.
More information on CORE is available at www.regulation.gc.ca.
For information on regulatory training opportunities, visit the Canada School of Public Service.

Step 2: Analysis and Development of the Regulatory Impact Analysis Statement

The CDRM requires regulatory organizations to conduct detailed analyses (depending on the level of impact determined by the triage) and undertake thorough consultations when developing a regulatory proposal. The results of these processes are summarized and presented to decision makers and the public in the RIAS, which is published in the Canada Gazette. The RIAS provides a cogent, non-technical synthesis of information that allows the various RIAS audiences to understand the issue that is being regulated, the reason the issue is being regulated, the government's objectives, and the costs and benefits of the regulation and who will be affected, who was consulted in developing the regulation, and how the government will evaluate and measure the performance of the regulation against its stated objectives.

Performance Measurement and Evaluation of Regulation Activities

As noted earlier in this guide, the life-cycle approach introduced by the CDRM requires that regulations continually meet their policy objectives. Regular, ongoing performance measurement and evaluation of regulations is thus an important aspect of the federal regulatory process.
Performance measurement and evaluation of regulation activities may occur under a number of circumstances. In the case of high-impact regulations projects, regulatory organizations are required to complete a Performance Measurement and Evaluation Plan (PMEP) and summarize the main PMEP elements in the RIAS.
Low- and medium-impact regulations may be examined from time to time by the regulatory organization, either as part of a regular review cycle during a broader review of the policy objectives (e.g., after a report from the Office of the Auditor General) or in response to comments received from the public or other stakeholders.
The Performance Measurement and Evaluation Handbook provides further information on this subject.

Your TBS-RAS analyst is particularly involved in the process related to the development and approval of the RIAS. Although the analyst's responsibility is to provide advice and assistance throughout the regulatory development process, the CDRM specifically tasks TBS-RAS to review regulatory proposals, challenge departments and agencies on the quality of regulatory analyses, and advise them on how to meet the CDRM's requirements (i.e., the challenge function).

Your TBS-RAS analyst will work with you to ensure that the RIAS contains sufficient and meaningful information on the impact of the proposed regulation, is written in plain language with a minimum of technical language and jargon, and is consistent with the language used in the enabling act and regulations. Your analyst may request other information that is pertinent to the proposal to develop a more complete understanding of it (e.g., risk assessment, white papers, and presentations)

The challenge function is undertaken in a spirit of collaboration. Early review and challenge is a process that can markedly improve the quality of a regulatory proposal and help ensure compliance with the analytical requirements of the CDRM. It can also ensure that the regulatory proposal is well aligned with government priorities and that necessary policy, legislative, and funding decisions have been received or are being sought. Based on their familiarity with the broader regulatory environment, this is also an opportunity for TBS-RAS analysts to identify proposals that may conflict with or infringe upon other existing or proposed regulations or that could benefit from increased communication or cooperation among regulatory organizations. Ultimately, early collaboration will facilitate consideration of the proposal by Treasury Board ministers.

Regulatory Impact Analysis Statement Templates

There are two RIAS formats, i.e., templates for low and medium-high impacts, that reflect the requirements of the CDRM.

This RIAS format became a requirement for all new regulatory proposals on April 1, 2008. The templates are available on the Treasury Board of Canada Secretariat website.

As indicated in section 3.0 of the CDRM, regulatory organizations may also be required to conduct other analyses to respect other legislative and policy requirements. For assistance with the requirements of the CDRM and other analyses, please contact your TBS-RAS analyst.

Compliance with International Obligations

The CDRM requires departments and agencies to ensure compliance of their regulatory proposals with Canada's international obligations, including in the area of trade. Regulatory organizations should determine at the triage stage whether their regulatory proposal is affected by an international trade agreement to which Canada is a party (e.g., the World Trade Organization's Agreement on Technical Barriers to Trade, the Agreement on the Application of Sanitary and Phytosanitary Measures, and chapters 7 and 9 of the North American Free Trade Agreement) and include this information in the submission to the Treasury Board. For assistance in making this determination, contact the Technical Barriers and Trade Regulations Office, Foreign Affairs and International Trade Canada, at 613-944-8977.

Does Your Proposal Have Financial or Program Implications?

If your regulatory proposal has financial or program implications, it may have to meet additional requirements, such as needing a Treasury Board submission (e.g., approval of funding and terms of reference). This should be discussed with your TBS-RAS analyst as early as possible.

Such proposals will also need to be considered by Treasury Board in its dual roles as the Government of Canada's management board (Part A) and regulatory advisor (Part B).

Help Is Available

A number of resources are available to assist you in developing a regulatory proposal.

The following guidance documents can be found on the Regulatory Affairs website:

Assessing, Selecting, and Implementing Instruments for Government Action;
Canadian Cost-Benefit Analysis Guide: Regulatory Proposals;
Guidelines on International Regulatory Obligations and Cooperation; and
Guidelines for Effective Regulatory Consultations.

Other helpful resources are available and listed at the end of this document.

The Importance of Consultations

The CDRM requires regulatory organizations to identify parties that may be interested in or affected by a regulatory proposal and to provide these parties with opportunities to take part in open and meaningful consultations at all stages of the regulatory process. With this in mind, a key aspect of the TBS-RAS challenge function is to ensure that parties affected by a regulatory proposal have been given adequate opportunities to provide input and express concerns they may have related to the design, implementation, or impacts of the proposal.
When undertaking consultations, the CDRM requires regulatory organizations to do the following:

Inform and engage Canadians on the nature and implications of the public policy issue based on available evidence, science, or knowledge;

Include Canadians in developing policy objectives;

Set out the process and timelines in a clear manner so that affected parties can organize and provide input; and

Provide timely feedback to Canadians and affected parties on the outcome of the consultations and on the priorities considered in decision making.

The CDRM also requires departments and agencies to work with Aboriginal communities, organizations, and governments to ensure that all obligations that may exist in relation to rights protected by section 35 of the Constitution Act, 1982 are met. Further guidance on Aboriginal consultation is available from Indian and Northern Affairs Canada in its publication, Interim Guidelines for Federal Officials to Fulfill the Legal Duty to Consult.
Regulatory organizations are encouraged to provide early public notification of their intent to regulate whenever possible, because affected parties are more likely to accept regulations when they have an opportunity to help define the problem and identify a solution. Early public notification can be provided through a regulatory organization's Report on Plans and Priorities, publication and regular updating of a departmental regulatory plan on a website, or publication of a Notice of Intent in the Canada Gazette, Part I.

Step 3: Drafting the Regulations

You have two options for developing the text of a regulation:

Provide JUS with drafting instructions and request that JUS Legislative Counsel develop the text; and
Develop a draft of the proposed regulation in-house and submit the text to the JUS for examination.

Drafting Instructions

Drafting instructions are prepared in both official languages by program officials. It is important to be clear and accurate. The instructions may take various forms, such as:

A detailed explanation of the policy that is being implemented through the proposed regulation;
A point-form outline of the proposed regulation;
A request to include or exclude specific words or concepts in the text; and
A request to incorporate additional elements into an existing regulation.

When amending existing regulations, the drafting instructions should explain the purpose and expected outcome of the proposed changes. They may also include suggestions on where or how to insert new requirements, should indicate applicable jurisprudence, if any, and note any cross-references made in the regulations.

Developing Draft Text In-House

In-house drafting of a regulation is the responsibility of program officials and is done in collaboration with the organization's legal services unit. Three copies of these proposed instructions, in both official languages, are required by the JUS for examination (see Step 4). Make sure that the English and French versions of the text are equivalent. The proposed text becomes the "instructions," and the JUS Legislative Counsel will make any necessary changes to that draft text.

Other Requirements

Whether you are submitting drafting instructions or draft text, the following documents are also required by JUS:

A draft Notice of Pre-Publication in both official languages (unless the regulation is exempted from pre-publication);
A draft RIAS in both official languages;
a copy of the finalized Triage Statement co-signed by the regulatory organization and TBS-RAS; and
Any documentation that may have been exchanged with the Standing Joint Committee for the Scrutiny of Regulations respecting the regulation in question.

These documents may be submitted electronically or in paper form. If submitted in paper form, two copies of each document are required.

You should also advise the JUS Legislative Counsel about any legal issue(s) that may arise from the proposed regulation, inform it of any legal opinions that have been obtained in relation to the issue, and refer to the applicable jurisprudence.

Regulatory Proposals as Confidences of the Queen's Privy Council (Cabinet Confidences)

Regulatory proposals are intended for a committee of Cabinet (i.e., Treasury Board) and are therefore confidences of the Queen's Privy Council. The confidentiality surrounding Cabinet discussions extends to items on the agenda, the nature of the discussions among ministers, and the decisions they take.
Confidences of the Queen's Privy Council for Canada are described in section 69 of the Access to Information Act, section 70 of the Privacy Act, and section 39 of the Canada Evidence Act. They include briefing notes for the Treasury Board, draft OICs, draft RIASs, and draft regulations. Please note that draft regulations can be released for consultation as long as the version that is to be released is approved by the appropriate official, i.e., usually at least at the director general level. Upon release, the Cabinet confidence is removed, but once the draft regulations come back for further work, the confidence resumes.
When conducting consultations on regulatory proposals, it is important to first discuss with your legal services unit any documents and materials you plan to release in order to prevent the inadvertent release of confidences of the Queen's Privy Council.
Additional information on regulatory consultation requirements, processes and tools is available in the Guidelines for Effective Regulatory Consultations. For information specific to confidences of the Queen's Privy Council, please also consult the Treasury Board Manual, Access to Information, chapters 2–6, December 1993.

Step 4: Examination by the Department of Justice Canada Legislative Counsel and Stamping

Pursuant to subsection 3(2) of the Statutory Instruments Act, the Clerk of the Privy Council, in consultation with the deputy minister of JUS (in practice, this responsibility is delegated to the JUS Legislative Counsel) conducts a legal examination of all proposed regulations to ensure that the following:

The regulation is authorized by the enabling act.
The regulation does not constitute an unusual or unexpected use of the authority under which it is to be made.
The regulation does not trespass unduly on existing rights and freedoms and is not inconsistent with the Charter of Rights and Freedoms or with the Constitution Act, 1982.
The form and drafting of the regulation is in accordance with established standards.
The text is also reviewed by other specialists (revisors, jurilinguists, and bijurists).

JUS examination occurs either

after a draft text is submitted by a regulatory organization, in which case JUS will re-draft sections that do not meet accepted standards, or;
while the text is being drafted by JUS.

Once the examination is completed, the JUS Legislative Counsel issues a discussion draft to the sponsoring regulatory organization. The discussion draft incorporates any changes that may have been necessary as a result of the legal examination. The regulatory organization then undertakes a final review of the text and confirms that it reflects the relevant policy.

Request for Stamped Copies

A written request (letter or email) for stamped copies of a regulation should be sent to the JUS Legislative Counsel by the manager responsible for the regulatory proposal after concurrence and approval by the departmental legal services unit. This stamp indicates that the proposed regulation has been examined in accordance with the Statutory Instruments Act. If there is any outstanding matter that represents a high legal risk, the deputy minister of JUS will advise the Clerk, in writing, in accordance with the Clerk's obligations under section 3 of the Statutory Instruments Act. The Clerk will then advise the regulatory organization accordingly. When seeking a stamped copy from JUS, a separate copy of the draft regulations should also be sent to the director of Cabinet Committee Operations at TBS-RAS.

Step 5: Signed Submission Goes to PCO-OIC

Regulatory proposals, once approved for submission by the sponsoring minister, are forwarded to PCO-OIC, which is responsible for putting the proposal before the Treasury Board. A regulatory submission must be received by PCO-OIC a minimum of 15 working days prior to the Treasury Board meeting at which the proposal may be scheduled for consideration. Proposals will be scheduled for consideration by the Treasury Board at the discretion of the President.

The Treasury Board meets on a weekly basis when Parliament is in session and as required at other times of the year (e.g., during the summer recess). Deadline dates are adjusted (postponed) to account for holidays during this period. Proposals received after the deadline will be placed on the agenda for the following Treasury Board meeting. To be considered, proposals must be complete and comply with the analytical requirements of the CDRM.

Requests for urgent consideration of proposals received after the deadline require a letter from the sponsoring minister to the President of the Treasury Board justifying the urgency and indicating the reason for the lateness of the proposal. Before submitting such a letter, please consult with your TBS-RAS analyst, who can provide guidance on the drafting of the letter. When finalized, the letter (signed by the minister) should be included as part of the regulatory submission or, if the submission has already been sent, the letter should be delivered to the attention of the Assistant Clerk of the Privy Council (OIC) by a departmental official, by secure messenger, or by secure fax to 613-957-5773. If sent by secure fax, the original letter must follow by a departmental official or secure messenger.

Consistent with established Treasury Board practice, and as is the case with all proposals scheduled for consideration, the consideration of urgent proposals will be at the discretion of the President.

The checklist below identifies the documents that are to be sent to the Assistant Clerk of the Privy Council. Unless otherwise specified (see templates in Part IV of this Guide), all documents are required in both official languages and must be prepared as separate versions rather than in a side-by-side format.

Checklist for Pre-Publication in Part I of the Canada Gazette
Document	Original Document(s)	Photocopies
Letter of Transmittal	Original (English or French)	4
Notice	Stamped original	5
Regulations	Stamped original	5
Regulatory Impact Analysis Statement (RIAS)	Original (which must include the cover page signed by the minister) and electronic version of the document	5
Supplementary Note (if applicable)	Original and electronic version of the document	4
Communications Plan	Original and electronic version of the document	4
Request for Insertion in the Canada Gazette	Original	None
CD or Diskette	One CD, diskette or USB key containing electronic versions of documents and artwork	N/A

Upon receipt of a signed submission, PCO-OIC will verify that:

The proposed regulation is under the authority of the GIC.
All the required documents have been submitted and bear the correct signatures.
The proposed regulation has been stamped.
The RIAS and Request for Insertion in the Canada Gazette (PDF Document - 161 KB) (Form PWGSC-TPSGC 3105-1) have been signed by the correct person.

PCO-OIC will then forward a copy of the submission to TBS-RAS for review and preparation of a briefing note for Treasury Board ministers. If any questions arise, your TBS-RAS analyst may contact the official named in the RIAS or the departmental regulatory coordinator.

Step 6: Treasury Board Meeting and Decision

TBS-RAS is responsible for briefing Treasury Board ministers on regulatory proposals. Officials of the regulatory organization (preferably at the level of assistant deputy minister (ADM) but no lower than the director level) are sometimes required to be available during the meeting to provide additional information. TBS-RAS will inform you when this is the case, and TBS-RAS will advise as to the time and place of the meeting, which is a Cabinet confidence.

The Treasury Board, as a Cabinet committee, may make any of the following decisions:

Approve or reject pre-publication of the proposed regulation;
Approve or reject requests for exemptions from pre-publication;
Send the item to Cabinet or one of its other committees for consideration;
Refer the matter back to the responsible minister for further consideration and information; and
Defer the item to another meeting.

Approved submissions are sent to PCO for action (see Step 7). Your TBS-RAS analyst will inform you of any follow-up actions that may be needed, refusals of regulatory proposals by the Treasury Board, or proposals that are deferred.

Step 7: Pre-Publication in the Canada Gazette, Part I

If the approval of the Treasury Board is obtained, PCO-OIC forwards the proposed regulation and the accompanying RIAS to the Canada Gazette Directorate of PWGSC.

The proposed regulation and the RIAS are then pre-published in the Canada Gazette, Part I. Additional details about this process (e.g., publication requirements, publication deadlines, insertion rates, and the Request for Insertion (PDF Document - 163.72 KB) are available from the Canada Gazette.

It is through publication in Part I that the government includes Canadians in the regulatory process. Pre-publication gives all Canadians a chance to submit their comments about a proposed regulation before it is made. (The name and contact information of the person to whom comments should be sent is provided in the RIAS.)

The standard period for pre-publication in the Canada Gazette, Part I, is 30 days, unless the following takes place:

Another period is specified by the enabling act.
Treasury Board ministers agree to a different pre-publication period.
The proposed regulation affects international trade, in which case a pre-publication period of at least 75 days is required in order for Canada to fulfill its obligation of notification under various trade agreements.

A regulatory organization may decide, at its discretion, to extend the pre-publication period. (This may be done, for example, if key stakeholders require additional time to review and comment on the proposed regulation). In this case, a notice should be placed in the Canada Gazette, Part I, announcing the extension and explaining the reason(s). An explanation of the extension should also be included in the RIAS when the final approved regulations are published in the Canada Gazette, Part II.

Extra Editions

A new edition of the Canada Gazette, Part I, is published every Saturday, which gives regulatory organizations ample opportunity for timely pre-publication of their regulatory proposals. In exceptional circumstances, however, a proposed regulation may be pre-published in an extra edition of the Canada Gazette to allow the proposed regulation to be made public in advance of the normal schedule. A decision on whether this is appropriate and feasible will be made, on a case-by-case basis, by the Canada Gazette Directorate and PCO.

Special arrangements should be made, well in advance of the publication date, with the manager, Canada Gazette, by telephone at 613-943-5261 or by email at infogazette@tpsgc-pwgsc.gc.ca.

Tabling in Parliament

Many enabling acts require that their regulations be tabled in the House of Commons and/or the Senate, and some require regulations to be referred to parliamentary committees. The timing of tabling may vary: some statutes require tabling before the proposed regulation is "made" (e.g., the Immigration and Refugee Protection Act, subsection 5(2)), while others require tabling after the regulation is made (e.g., the Federal Court Act, section 46).

If tabling is required, your TBS-RAS analyst can assist you in determining the appropriate time and process. Your legislative or parliamentary affairs group will also help coordinate the tabling process, in conjunction with PCO. The Letter of Transmittal to the Assistant Clerk of the Privy Council (see Step 5) should indicate if a proposal requires tabling and the timing of this event.

More About the Canada Gazette

Part I of the Canada Gazette is published every Saturday and contains all public notices, official appointments and proposed regulations from the Government of Canada, as well as miscellaneous public notices from the private sector that are required to be published by a federal statute or by regulations.
Part II is published every other Wednesday and contains all regulations that have been made that must be published under s.11 of the Statutory Instruments Act, as well as other classes of statutory instruments, such as Orders in Council, orders, and proclamations.
Part III, which mainly contains public acts of Parliament, is published as soon as is reasonably practicable after royal assent to the acts. It also contains a list of the Proclamations of Canada and Orders in Council relating to the coming into force of federal acts. (JUS determines the publication date for each issue of Part III.)
The Canada Gazette is available in most public libraries and depository libraries of Canadian government information. Copies are also available online and by paid subscription. A history of the Canada Gazette is also available online.

Seeking Final Approval, Publication, and Registration

Following the pre-publication period, many of the same steps are undertaken again in a modified form to complete the regulatory development process. Your TBS-RAS analyst continues to play a critical guidance and challenge role throughout this stage of the process.

Step 8: Post-Pre-Publication Analysis

The CDRM emphasizes that regulatory organizations are to "take the comments received [during pre-publication] into consideration." Further, it requires regulatory organizations to "provide timely feedback to Canadians and affected parties on the outcome of the consultations and on the priorities considered in decision making."

In keeping with these requirements, all comments received during the pre-publication period should be given careful consideration to determine whether changes to the text are warranted. It may be helpful to use a tracking document to monitor the comments received. This can be especially useful if the regulatory organization is later called upon to explain how stakeholder concerns were addressed or why it might not have been possible to do so. A template for a tracking document is provided in Part 4 of this guide.

If changes are required to the proposed regulation, the JUS Legislative Counsel will examine them (based on re-drafting instructions provided by the regulatory organization) in accordance with section 3 of the Statutory Instruments Act and make those changes that are appropriate. In addition to public and stakeholder comments, any changes that may have occurred, domestically or internationally, that could affect the wording or intent of the proposed regulation should be considered.

Revise the RIAS to indicate the date of pre-publication, summarize the comments received, explain how they were handled, and provide the rationale for the regulatory organization's response (i.e., the decision to change or not change the regulation). The regulatory organization should then obtain concurrence of the TBS-RAS analyst on the updated RIAS and send the JUS Legislative Counsel a copy for information.

If no comments were received during pre-publication, the RIAS should include the phrase, "This regulation was pre-published in the Canada Gazette, Part I, on [date] and no comments were received."

Step 9: Examination by the JUS Legislative Counsel and Stamping

Before submitting a regulatory proposal for it to be made, you must obtain new stamped copies even if no changes were made to the text after pre-publication. This version of the stamp differs from the stamp used during the pre-publication stage: it will indicate "CGII" to show that the regulation has been examined, in accordance with the Statutory Instruments Act, for publication in Part II of the Canada Gazette.

The regulatory organization is responsible for ensuring that the authority to make the regulation has not been amended or removed in the meantime.

The JUS Legislative Counsel performs the same legal examination function at this stage as during the pre-publication stage (see Step 4).

Is a Second Pre-Publication Required?
There may be circumstances where a second pre-publication of a regulatory proposal is warranted.
If substantive changes are made to the regulation after prepublication, a second round of pre-publication ensures that stakeholders are aware of the extent of the changes and have an opportunity to comment. It is highly advisable to discuss this with your TBS-RAS analyst.
A proposed regulation may need to be pre-published a second time if a period of 18 months or more has passed since the initial prepublication. This informs Canadians that, despite the delay, the regulation will proceed. An explanation for the delay should be included in the revised RIAS.
If there is a change in government or a ministerial shuffle, it may also be necessary to confirm with the recommending minister and the Privy Council Office as to whether a second pre-publication is warranted.
In all of the above cases, the TBS-RAS analyst will advise Treasury Board ministers if a second pre-publication is deemed necessary and why.

Step 10: Final Regulatory Submission Goes to PCO-OIC

Once the final regulatory proposal has been approved by the responsible minister(s), the documents identified in the checklist below should be sent to the Assistant Clerk of the Privy Council. Unless specified otherwise, all documents are required in both official languages and must be prepared as separate versions rather than in a side-by-side format.

PCO-OIC will only accept documents that bear the correct signatures and have a stamped regulation. PCO-OIC will forward a copy of the regulatory proposal to TBS-RAS.

Checklist for final publication in Part II of the Canada Gazette:
Document	Original Document(s)	Photocopies
Letter of Transmittal	Original	4
Minister's Recommendation to the GIC	Original, signed and dated, printed on the minister's departmental stationery	4
Order in Council	One stamped original–JUS to provide PCO with an electronic version of the document(s)	6
Regulations	One stamped original–JUS to provide PCO with an electronic version of the document(s)	10
Regulatory Impact Analysis Statement (RIAS)	Original (which must include the cover page signed by the minister) and electronic version of the document	5
Supplementary Note (if applicable)	Original and electronic version of the document	4
Communications Plan	Original and electronic version of the document	4
Request for Insertion in the Canada Gazette	Original	None
CD or Diskette	One CD, diskette, or USB key containing electronic versions of documents and artwork	N/A

Step 11: Making of the Regulation by the Governor in Council

The GIC is the Governor General of Canada acting on the advice of Cabinet. Since December 2003, advice to the Governor General on behalf of the Queen's Privy Council has been provided by the Treasury Board.

Similar to proposals seeking pre-publication, TBS-RAS briefs Treasury Board ministers on submissions seeking final approval. The ministers will consider the results of pre-publication along with other information in the regulatory submission and will decide whether to recommend that the Governor General make the regulations as presented in their final form.

If the Treasury Board does not agree to recommend the making of a regulation, it may do the following:

Request a second pre-publication;
Send the item to Cabinet or one of its other committees for consideration;
Refer the matter back to the recommending minister for further consideration; and
Refuse to approve the submission.

Again at this step, you may be asked to have an experienced and knowledgeable official available (preferably at the ADM level but no lower than the director level) to answer questions or provide additional information during the Treasury Board meeting. TBS-RAS will advise when this is necessary, and TBS-RAS will inform the identified official of the time and place of the meeting.

A regulation is "made" when the Governor General signs the Order in Council attached to the regulation. This usually happens shortly after the Treasury Board meeting.

Step 12: Registering, Coming into Force, Publishing in Canada Gazette, Part II, and Distributing Regulations

Registration

Section 5 of the Statutory Instruments Act requires that a regulation be transmitted to the Clerk for registration within seven days. In practice, registration is usually done within 48 hours of the Treasury Board meeting at which the regulation is considered.

To register a regulation, PCO-OIC records the title of the regulation, the title of the regulatory organization making the regulation, the legislative or other provision under which it is made, the date it is made, and the date of registration. The regulation is also assigned a number, preceded by the acronym SOR, which stands for statutory orders and regulations, or SI, which stands for statutory instruments.

Certain classes of regulations may be exempted from registration under section 7 of the Statutory Instruments Regulations. Your JUS legislative counsel can advise you on this matter, and your TBS-RAS analyst should also be consulted.

Coming into Force

Regulations that must be registered generally come into force at midnight on the date of registration provided for in section 6 of the Statutory Instruments Act or on a day after registration that is specified in the regulations.

However, a regulation may come into force on a day that is up to seven days before its registration (but not earlier than the day it is made) if the day of coming into force is specified in the regulation and the reasons it is not practical to come into force on registration are provided to the Clerk of the Privy Council.

A regulation can take effect before it is made (i.e., be retroactive) only if the enabling act clearly authorizes the retroactivity and the text of the regulation specifies the date.

In all cases, the government's decision to make a regulation must not be publicly announced until the OIC has been signed by the Governor General. However, it is possible to announce the intent to proceed with a certain course of action. Departmental communications advisors should also be consulted on any ministerial announcements related to the regulations and coordinate with PCO.

Publication

Section 11 of the Statutory Instruments Regulations requires that most regulations be published in the Canada Gazette, Part II, within 23 days of their registration (Part II is published every second Wednesday).PCO-OIC coordinates this process. As in the case with pre-publication, an extra edition of the Canada Gazette, Part II can be published on an exceptional basis (e.g., to enable a regulation to be published and enforced in advance of the normal publication schedule to meet an urgent need).

Failure to publish a regulation does not make it invalid but does prevent the punishment of contraventions of the regulation. This is because the constitutional principle of the rule of law requires that the terms of a law must be knowable.

There are two exceptions to this general rule. A person or organization contravening an unpublished regulation can be punished if the regulation is exempt from publication or if the regulation expressly provides that it applies before it is published in the Canada Gazette, Part II. In such cases, however, it must be proved that reasonable steps were taken to bring the substance of the regulation to the notice of those likely to be affected by it.

Distribution

Signed copies of an Order in Council are normally mailed to the sponsoring minister and to the deputy minister or agency head within five days of signature.

Usually, OIC, including those making regulations, are made publicly available three working days after approval by the Governor General. They can be found at the PCO Reading Room (4th Floor, 85 Sparks Street, Ottawa), where visitors can obtain a short précis list of orders and regulations, together with the name of the sponsoring department, the legal authority, and the Privy Council number, and they can be found on the Web at the Orders in Council Database.

Review by the Standing Joint Committee for the Scrutiny of Regulations

The mandate of the Standing Joint Committee for the Scrutiny of Regulations is defined by the Statutory Instruments Act, the Legislation Revision and Consolidation Act, and the Standing Orders of the House of Commons (the permanent written rules under which the House of Commons regulates its proceedings). Pursuant to the Statutory Instruments Act, the Committee can scrutinize any statutory instrument made on or after December 31, 1971.

Composed of eight senators and a proportionate number of members of the House of Commons, the Committee has the same powers that other standing committees have. It may sit while the House is sitting and when the House stands adjourned; send for persons, papers and records; print papers and evidence; and delegate to a subcommittee all or any of its powers (except the power to report directly to the House). It may also table reports in the House and request government responses to them. In addition, the Committee has the power to initiate the revocation of a regulation.

The Committee reviews all statutory instruments referred to it on the basis of 13 criteria, such as conformity with the Canadian Charter of Rights and Freedoms or the Canadian Bill of Rights; compliance with the Statutory Instruments Act with respect to transmission, registration, or publication; and unusual or unexpected use of the powers conferred by the enabling legislation.

More information on the Standing Joint Committee for the Scrutiny of Regulation is available in section 17 of the House of Commons Procedure and Practice Online.

Part 3: Critical Path Template

Proposed Critical Path Template

To assist in meeting the timelines required for the submission of regulatory proposals for pre-publication and final approval, a critical path template is provided below.

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Critical Path Template (RTF version, 139 Kb)
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