I. CABINET DIRECTIVE ON REGULATORY 
MANAGEMENT  
© Her Majesty the Queen in Right of Canada, 2012 
Catalogue No.  
ISBN 
 
TABLE OF CONTENTS  
1. Our Commitment to Canadians  
2. Introduction  
3. Scope of Application  
4. Effective Date  
5. The Life Cycle Approach to Regulating  
6. Regulatory Impact Analysis  
A. Consultation  
B. Identifying and assessing public policy issues  
C. Setting public policy objec tives and expected outcomes  
D. Selecting the appropriate mix of government instruments  
E. Assessing legal implications and other Cabinet directions  
F. Compliance with international obligations  
G. Analyzing the benefits and costs of regulation  
H. Recommending an option  
I. Coordination  
J. Cooperation  
 With provincial and territorial governments  
 With jurisdictions in other countries or with the international 
community  
K. Planning for implementation, compliance, and enforcement  
 Implementation  
 Compliance and enforcement  
L. Measuring, evaluating, and reviewing regulation  
 Measuring and reporting on performance  
 Evaluating regulatory programs  
 Reviewing regulatory frameworks  
7. Regulatory Management  
M. "One-for-One" Rule  
N. Small business lens  
O. Forward regulatory planning  
P. Service performance  G/TBT/2/Add.6/Rev.3 
Page 2  
  Q. Reporting  
R. Review of the Directive  
8. Roles and Responsibilities  
 Federal Departments and Agencies  
 Treasury Board Secretariat  
 Department of Justice  
 The Privy Council Office  
 The Department of Public Wo rks and Government Services  
9. References  
10. Enquiries and Further Information  
11. Appendix: International Trade Obligation s Regarding Specific Requirements for 
the Design and Implementati on of Technical Regulation s, Conformity Assessment 
Procedures, and Sanitary and Phytosanitary Measures  
 
 
 
1. OUR COMMITMENT TO CANADIANS  
1. The Government of Canada is committed to protecting and advancing the public 
interest by working with Cana dians and other governments to ensure that its regulatory 
activities result in the grea test overall benefit to current and future generations of 
Canadians. 
2. When regulating, the government will: 
i. 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; 
ii. Advance the efficiency and effectiveness  of regulation by ascertaining that 
the benefits of regulation justify the costs, by focusing human and financial 
resources where they can do the most good, and by demonstrating tangible 
results for Canadians; 
iii. Make decisions based on evidence  and on 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; 
iv. Promote a fair and comp etitive market economy  that encourages 
entrepreneurship, investment, and innovation; 
v. Monitor and control the administrative burden  (i.e., red tape) of regulations 
on business and be sensitive to the bu rden that regulations place on small 
business; 
vi. Create accessible, understandable, and responsive  regulation through 
engagement, transparency, accountab ility, and public scrutiny; and 
vii. Require timeliness, policy coherence, and minimal duplication  throughout 
the regulatory process by consulting, coordinating, and cooperating across the 
federal government, with other governments and juri sdictions in Canada and 
abroad, and with busi nesses and Canadians. 
  G/TBT/2/Add.6/Rev.3 
 Page 3 
 
  2. INTRODUCTION  
3. Regulation is a key policy instrument used by government to enable economic activity 
and to protect the health, safety, security, and environment of Canadians. 
4. Regulations are a form of law—they have binding legal effect and usually set out rules 
that apply generally, rather than to specific  persons or situations. Often referred to as 
"delegated," "secondary," or "subordinate le gislation," regulations are made by persons 
to whom or bodies to which Parliament has delegated authority, such as Cabinet (the 
Governor in Council), a minister, or an administrative agency. Authority to make 
regulations must be expressly dele gated through enabling legislation. 
5. Regulation is a necessary foundation of market economies. A robust and effective 
regulatory system provides consistency,  fairness, and transparency, and supports 
innovation, productivity, and competition. 
6. An effective regulatory system is not just  for protective purposes. Regulation often is 
an enabler. For example, in the economic sphere, it establishes the rules for fair 
markets, reduces barriers to trade through alignment with trading partners, clarifies 
conditions for the use of new products, services, and technologies, and fosters new 
investment. 
 
3. SCOPE OF APPLICATION  
7. Federal departments, agencies, and entities:1  The Cabinet Directive on 
Regulatory Management  applies to all federal department s, agencies, and entities over 
which the Cabinet has either general author ity or a specific authority relating to 
regulation making, or both such authorities: 
i. Federal departments, agencies, and enti ties under the general authority of 
Cabinet include all of the public administration, including ministers, with the 
exception of certain federal entities that are created by  statute and that have an 
existence, a mandate, and powers with  substantial independence from the 
government. 
ii. Entities not under the general authority of Cabinet must comply with the Directive 
if the Governor in Council or  the Treasury Board has a specific authority related to 
regulation making. 
iii. Entities not under the general authority of Cabinet and over which Cabinet does 
not have a specific authority should, as a matter of good regulatory practice, 
follow the Directive and apply its requirem ents as appropriate to their context. 
 
8. Instruments:  The Directive applies to all secondary legislation, that is, all 
prescriptive documents made by  entities to which the Directive applies as set out in 
sections 7 (i), (ii) and (iii) and for which Parliament has delegated authority. These 
instruments include the following: 
i. All documents that are regulations under the Statutory Instruments Act ;2 and 
                                                      
1  "Federal departments, agencies, and entities" an d "ministers" to which the Directive applies will 
be referred to hereafter as "departments and agencies." 
2  Neither an exemption from any requirement of the Statutory Instruments Act  (such as 
registration, examination or publication) nor an entire exemption from that act exempts a 
document of a legislative nature from the Directive. 
 
 G/TBT/2/Add.6/Rev.3 
Page 4  
  ii. All other documents made under the authorit y of an Act of Parliament that are of 
a legislative nature. 
9. The Directive applies to all stages of the regulatory life cycle (i.e., planning, 
development, implementati on, evaluation, and review ), including regulatory 
management. 
 
4. EFFECTIVE DATE 
10. Section 7 (N) of this Directive takes e ffect on January 1, 2012. Section 7 (P) takes 
effect on December 1, 2012. The remaining sections take effect on April 1, 2012. The 
Directive updates and replaces the Cabinet Directive on Streamlining Regulation  (dated 
April 1, 2007) and the Government of Canada  Regulatory Policy (dated November 1999). 
 
5. THE LIFE CYCLE APPROACH TO REGULATING  
11. The Cabinet Directive on Regulatory Management  confirms a "life cycle" approach to 
regulation making. The life cycle approach re cognizes that attentio n must be given not 
only to regulatory developmen t and analysis but also to the implementation, evaluation, 
and review of regulations. As a result, the lif e cycle approach improv es the effectiveness, 
efficiency, and accounta bility of the regulatory system  to support the government's 
commitment to Canadians. 
 
6. REGULATORY IMPACT ANALYSIS  
12. In consultation with the Regulatory Affair s Sector of the Treasury Board Secretariat, 
departments and agencies will assess the impa ct of regulatory proposals at an early 
stage to determine where approval processe s can be streamlined and where resources 
should be focused. The following factors will be considered in this assessment: 
i. Potential impact of the regulation on health and safety, security, the 
environment, and the social and ec onomic well-being of Canadians; 
ii. Cost or savings to governme nt, business, or Canadians, and the potential impact 
on the Canadian economy and its international competitiveness; 
iii. Potential impact on other federal depart ments or agencies, on other governments 
in Canada, and on Canada's foreign affairs; 
iv. Degree of interest, contention, and suppo rt among affected parties and among 
Canadians; and 
v. Overall expected impact: Recognizing that regulatory impact analysis can be 
resource intensive, the Directive emphasizes the principle of proportionality—
analysis should be focused where it is most needed. Therefor e, at the earliest 
stages of regulatory design, depart ments and agencies must assess the 
regulatory proposal, in consultation with the Regulatory Affairs Sector of the 
Treasury Board Secretariat, to determine its overall expected impact (i.e., low, 
medium or high) and the part icular analytical and other requirements to be met. 
13. Emergency situations:  When there is an immediate an d serious risk to the health 
and safety of Canadians, thei r security, the environment, or  the economy, an expedited 
process may be required. In these cases, de partments and agencies will work with the 
Regulatory Affairs Sector of the Treasury Bo ard Secretariat to proceed in a manner that 
most effectively protects the public interest. 
14. Regulatory Impact Analysis Statement (RIAS):  A statement summarizing the 
analysis undertaken to design a regulatory  proposal under this Directive is to be  G/TBT/2/Add.6/Rev.3 
 Page 5 
 
  published in the Canada Gazette  in accordance with appr opriate guidance from the 
Regulatory Affairs Sector of th e Treasury Board Secretariat. 
(A) Consultation  
15. Departments and agencies are responsibl e for identifying interested and affected 
parties, and for providing them with opportuni ties to take part in open, meaningful, and 
balanced consultations at all stages of the regulatory process. When undertaking 
consultations, department s and agencies are to: 
i. Inform and engage Canadians on the nature  and implications of the public policy 
issue based on available evid ence, science, or knowledge; 
ii. Include Canadians in develo ping policy objectives; 
iii. Set out the process and timelines clearly so  that affected parties can organize and 
provide input; and 
iv. Provide timely feedback to Canadians and affected parties on the outcome of the 
consultations and on the priorities  considered in decision making. 
16. Departments and agencies are also to work with First Nations, Inuit, and Métis 
communities and peoples; with national, regional, and local Aboriginal organizations; 
and with Aboriginal governments and ensure that all obligations in relation to rights 
protected by section 35 of the Constitution  Act, 1982 , are met. 
17. Departments and agencies ar e to publish proposals in the Canada Gazette , Part I, to 
allow for a public comment period, and to then take the comments received into 
consideration. The standard comment period  is 30 days, but it can vary based on 
legislative requirements, international obligations, and other considerations. 
18. A minimum comment period of 75 days is required for proposals for new and 
changed technical regulations that may affect international trade. 
19. Publishing proposed regulations in the Canada Gazette  is not a substitute for 
meaningful consultations on the development of regulatory proposals. 
20. Cabinet may exempt proposals fr om publication in Part I of the Canada Gazette . An 
exemption may not be possible in cases wher e prepublication is required by statute. 
 
(B) Identifying and assessing public policy issues  
21. Departments and agencies are responsi ble for assessing public policy issues, 
including potential risks, and demonstrating through the best available evidence and 
knowledge that government intervention is needed. 
22. When assessing and documenting public po licy issues, departments and agencies are 
to: 
i. Analyze the public policy issue, its causes, and its context, including its urgency 
and immediate and long-term impacts; 
ii. Review, wherever possible, relevant ev idence-based assessments, analyses, 
standards, peer-reviewed publications, and the classification sy stems of provincial 
and territorial governments,  other countries or jurisd ictions, or international 
organizations; 
iii. Explain fully to decision makers and Cana dians the nature of the issue, how its 
impacts have changed over time, and why government intervention is needed; 
and G/TBT/2/Add.6/Rev.3 
Page 6  
  iv. Describe the scientific an d empirical evidence, un certainties, ethical 
considerations, and public views of the public policy issue. 
23. When there is a risk of serious or irreve rsible harm, the government recognizes that 
the absence of full scientific certainty shall not be used as a reason for postponing 
decisions to protect the health and safety of Canadians, the environment, or the 
conservation of natural resources. For gu idance on the applic ation of precaution, 
departments and agencies should consult A Framework for the Application of Precaution 
in Science based Decision Making about Risk . 
(C) Setting public policy obje ctives and expected outcomes  
24. Once policy issues have been assessed and it is determined that government 
intervention is required, departments and ag encies are responsibl e for setting public 
policy objectives that outline tangible outcomes for Canadians. Departments and 
agencies are to: 
i. Set measurable objectives that address th e public policy issue and its causes; 
ii. Establish linkages to enabling legislation and government priorities to ensure 
relevance and consistency; and 
iii. Develop and use performance indicators on an ongoing basis to monitor and 
report on progress against performance ex pectations, with a particular emphasis 
on high impact proposals. 
 
(D) Selecting the appropriate mix of government instruments  
25. Departments and agencies are responsi ble for assessing the effectiveness and 
appropriateness of regulatory and non-regu latory instruments for achieving policy 
objectives. 
26. Departments and agencies are to: 
i. Identify the institutions and parties that should be involved in addressing the 
public policy issue; 
ii. Identify the appropriate instrument or mi x of instruments, including regulatory 
and non regulatory measures, and justify their application before submitting a 
regulatory proposal; 
iii. Consider potential alternatives to regulation, including voluntary standards, 
information disclosure, and guidelines , and whether outcome or performance 
based approaches would be suitable; 
iv. Engage small businesses in alternative approaches to compliance (including 
costs); 
v. Demonstrate that the regulatory respon se is designed to address policy 
objectives; 
vi. Demonstrate that the regulatory response is proportional to the degree and type 
of risk; 
vii. Demonstrate that the regulatory response will not unduly affect areas that it was 
not designed to address; 
viii. Specify, particularly for technical regulations, regulatory requirements in terms of 
their performance rather than their desi gn or descriptive ch aracteristics; and 
ix. Make use of all or parts of relevant national or international standards, guidelines, 
and recommendations as a basis for tec hnical regulations and for conformity 
assessment procedures when they fu lfill intended policy objectives.  G/TBT/2/Add.6/Rev.3 
 Page 7 
 
   
(E) Assessing legal implications  and other Cabinet directions  
27. When designing regulations, departme nts and agencies are responsible, with 
assistance from the Department of Justice, for assessing the legal implications of the 
proposal and for ensuring that it is legally sound. 
28. Departments and agencies are therefore ex pected to take measures to ensure that 
regulations are: 
i. Authorized by enabling legislation or other law; 
ii. Consistent with the Constitution Act, 1867 , with the Constitution Act, 
1982 (including the Canadian Charter of Ri ghts and Freedoms and with particular 
note of any obligations relating to Aboriginal and treaty rights arising out of 
section 35), and with the Cana dian Bill of Rights, 1960; and 
iii. Well drafted and able to operate effectively with other related laws, particularly 
legislation of general application from Cabinet (including the Treasury Board), 
such as the following: 
 Statutory Instruments Act ; 
 User Fees Act ; and 
 Financial Administration Act . 
29. When regulating, departments and agen cies are responsible for ensuring that 
relevant directions from Cabinet and the Treasury Board are followed, including the 
following: 
 Cabinet Directive on Law-making ; 
 Cabinet Directive on the Environmental Assessment of Policy, Plan and Program 
Proposals ; 
 A Framework for the Application of Precau tion in Science-based Decision Making 
about Risk ; 
 A Framework for Science and Technology Advice: Principles and Guidelines for the 
Effective Use of Science and Technology Advice in Government Decision Making ; 
and 
 Policy on Service Standards for External Fees . 
 
(F) Compliance with international obligations  
30. Departments and agencies are to respect Canada's international obligations in areas 
such as human rights, health, safety, security, international trade, and the environment. 
They are also to implement provisions related to these obligations at all stages of 
regulatory activity, including consultation and notification, as applicable. 
31. To ensure the compliance of regulatory proposals, departments and agencies should 
seek the advice and assistance of: 
i. The Legal Bureau of the Department of Foreign Affairs and International Trade, 
which is responsible for the negotiation, creation, and interpretation of Canada's 
international legal obligations, and which provides advice concerning the 
interpretation and application of such obligations for regulation; 
ii. The Department of Foreign Affairs and In ternational Trade, which coordinates the 
implementation of Canada's international trade obligations, including the 
implementation of the World Trade Orga nization (WTO) Agreement and the North 
American Free Trade Agreement (NAFTA); G/TBT/2/Add.6/Rev.3 
Page 8  
  iii. The Department of Justice, with its specialized sections, and its departmental 
legal services units that advise depa rtments and agencies on legal matters, 
including the consistency of regulatory proposals with Canada's international 
obligations; and 
iv. The Trade Law Bureau of the Department  of Foreign Affairs and International 
Trade and the Department of Justice, which provides advice on Canada's 
international trade obligations. 
32. For more information on requirements related to Canada's international trade 
obligations for the design and implementation of technical regulations, conformity 
assessment procedures, and sanitary and phyt osanitary measures, see the appendix to 
this document. 
 
(G) Analyzing the benefits  and costs of regulation  
33. When determining whether and how to regulate, departments and agencies are 
responsible for assessing the benefits and costs of regu latory and non-regulatory 
measures, including government inaction. 
34. This analysis should include quantitative measures and, when it is not possible to 
quantify benefits and cost s, qualitative measures. 
35. When assessing options to  maximize net bene fits, departments and agencies are to: 
i. Identify and assess the pote ntial positive and negative economic, environmental, 
and social impacts on Ca nadians, business (includi ng small business), and 
government of the proposed regulation and its feasible alternatives; and 
ii. Identify how the positive and negative impacts may be distributed across various 
affected parties, sectors of the economy, and regions of Canada. 
36. Detailed requirements for complying with this Directive with respect to analyzing the 
benefits and costs of regulati on, including certain analytic al parameters and reporting 
standards, are set out in guidance from the Regulatory Affairs Sector of the Treasury 
Board Secretariat. This guidance includes th e Triage Statement, th e Regulatory Impact 
Analysis Statement Template and the Canadian Cost-Benefit  Analysis Guide for 
Regulatory Proposals . 
 
(H) Recommending an option  
37. When developing the option that maximi zes net benefits, depa rtments and agencies 
are to: 
i. Limit the cumulative administrative burden  and impose the least possible cost on 
Canadians and businesses that is nece ssary to achieve the intended policy 
objectives; 
ii. Demonstrate that the recommended option minimizes the regulatory burden on 
small businesses without comp romising risk protection; 
iii. Provide a justification for the recommend ed option where other less burdensome 
options for small businesses exist; 
iv. Ensure that regulatory restrictions on competition are fair, limited, and 
proportionate to what is necessary to achieve the intended policy objectives; 
v. Prevent or mitigate adverse impacts and enhance the positive impacts of 
regulation on the health, safety, security , and environment of Canadians, as well 
as on trade, investment , and competitiveness;  G/TBT/2/Add.6/Rev.3 
 Page 9 
 
  vi. Identify the scope and nature of residu al adverse environmental effects after 
mitigation and enhancem ent strategies have been considered; and 
vii. Identify necessary follow-up measures to  track environmental effects over time. 
 
(I) Coordination  
38. Departments and agencies are responsi ble for working together to develop and 
implement regulations to maximize effect iveness and minimize the cumulative and 
unintended impacts on Canadians and the econ omy. To do so, departments and agencies 
are to: 
i. Identify and consult with other federal departments and agencies that have a 
specific interest in the proposed regulation; 
ii. Identify similar or related regulatory re quirements—either exis ting or proposed—
in the area being regulated; 
iii. Assess these requirements to minimi ze cumulative impacts and develop 
complementary and cooperative appr oaches whenever possible; and 
iv. Coordinate the implementation and mana gement of regulati on to minimize 
complexity and duplication. 
 
(J) Cooperation 
 
With provincial and terri torial governments 
39. Departments and agencies are responsi ble for cooperating with provincial and 
territorial governments in the developmen t and implementation of regulations. 
Departments and agencies are to: 
i. Involve provincial and territorial counterparts in federal regulatory initiatives; 
ii. Identify and assess similar or related prov incial and territorial  requirements, and 
work with relevant jurisdictions to mana ge any cumulative im pacts and minimize 
duplication and conflicting requirements; 
iii. Comply with the Government of Canada's  intergovernmental agreements, such as 
the Agreement on Internal Trade; 
iv. Develop cooperative arrangements su ch as the mutual recognition of 
requirements, the adoption of consen sus based standards, consistency in 
reporting requirements, and collaborative compliance an d enforcement strategies 
whenever possible; and 
v. Establish national standards or common conformity assessment procedures to 
support and facilitate internal trade whenever possible. 
 
With jurisdictions in other countries or with the international community 
40. Departments and agencies are to take ad vantage of opportunities for cooperation, 
either bilaterally or through multilateral fora, by: 
i. Reviewing and influencing international best practices, sharing knowledge, 
adopting or contributing to the development and updating of international 
standards and conformity assessment proc edures, and developing and pursuing 
compatible approaches with international counterparts; G/TBT/2/Add.6/Rev.3 
Page 10  
  ii. Limiting the number of specific Canadian regulatory requirements or approaches 
to instances when they are warranted by  specific Canadian  circumstances and 
when they result over ti me in the greatest overal l benefit to Canadians; 
iii. Identifying the rationale for their approach , particularly when specific Canadian 
requirements are proposed; and 
iv. Minimizing regulatory diffe rences with key trading pa rtners (e.g., the United 
States) including through regulatory alignment, mutual recognition, and the 
development of compatible approaches. 
 
(K) Planning for implementation , compliance, and enforcement 
 
Implementation 
41. Departments and agencies are responsibl e for putting in place the processes to 
implement regulatory programs and to manage related human and financial resources 
effectively, including: 
i. Publishing service standards, including timelines for approval processes set out in 
regulations, setting transparent program objectives, and identi fying requirements 
for approval processes; 
ii. Taking advantage of opportunities for coordinating implementation and delivery 
with other departments and agencies, and with other governments in Canada that 
regulate in the same sector; 
iii. Planning and providing for the necessary human and financial resources that the 
recommended option would require, in cluding compliance and enforcement 
activities; 
iv. Ensuring that those charged with carrying out regulatory responsibilities have the 
necessary resources, skills, and abilities; and 
v. Providing reasonable time frames between the publication of new requirements 
and their coming into force, to allow sufficient time for businesses and Canadians 
to make the necessary adjustments. 
 
Compliance and enforcement 
42. Departments and agencies are responsibl e for promoting regulatory effectiveness by 
developing and implementing compliance and enforcement strategies . These strategies 
are to: 
i. Be developed in consultation  with affected parties, including those that must 
administer the regulation or comply with it; 
ii. Use an appropriate range of comp liance and enforcement tools; and 
iii. Provide timelines and processes for assessi ng and reviewing compliance activities. 
 
(L) Measuring, evaluating , and reviewing regulation  
43. Departments and agencies are responsible for ensuring that regulation continually 
meets its initial policy objectives and for reviewing regulatory frameworks on an ongoing 
basis. 
Measuring and reporting on performance 
44. Departments and agencies are to:  G/TBT/2/Add.6/Rev.3 
 Page 11 
 
  i. Identify the intended results of regulatory activities in managing a public policy 
issue and, before submi tting a regulatory propos al, develop time based 
performance indicators for sign ificant regulatory activities; 
ii. Take measures to ensure that monitoring  and reporting activities are effective 
while imposing the least possible bu rden on government, business, and 
Canadians; 
iii. Integrate performance measures that can be used to adjust regulatory design, 
choice of instruments, and co mpliance plans as needed; and 
iv. Collect performance information on the results of existing regulation and provide 
Canadians with this information in a timely manner. 
 
Evaluating regulatory programs 
45. Departments and agencies are to evaluate  their regulatory programs according to 
the time frames and cycle esta blished in the Treasury Board Policy on Evaluation  to 
demonstrate results for Canadians. Subjec t to the impacts and complexity of the 
regulatory programs, departments and agencies  are to assess the following areas, when 
appropriate: 
i. Inputs (e.g., resources, mandate, and enabling authorities), activities, 
effectiveness, ultimate outc omes of the regulatory pr ogram, and the extent to 
which the program contributed to the achievement of reported results; 
ii. Value for money (e.g., relevance, e fficiency, and cost-effectiveness); and 
iii. Governance, decision-making and accountability processes, service standards, 
and service delivery mechanisms. 
 
Reviewing regulatory frameworks 
46. Departments and agencies are to regu larly assess the results of performance 
measurement and evaluation to identify regula tory frameworks in need of review. Once 
identified, departments and ag encies are to examine the re gulation with a focus on: 
i. The effectiveness of the cu rrent regulation in meeting the policy objective; 
ii. The current instrument selection, level of intervention, and degree of 
prescriptiveness; 
iii. The clarity and accessibility of the regulation to users; and 
iv. The overall impact on competitiveness, including trade, investment, and 
innovation. 
47. Planning, setting of priorities and ti melines, and the measur ing and reporting of 
outcomes of regulatory review should be determined by departments and agencies in 
collaboration with affected parties. 
7. REGULATORY MANAGEMENT  
 
(M) "One-for-One" Rule  
48. Under the "One-for-One" Rule, departme nts and agencies are responsible for: 
i. Controlling the number of regulations by repealing at least one existing regulation 
every time a new one that imposes an admi nistrative burden (i .e., red tape) on 
business is introduced; and G/TBT/2/Add.6/Rev.3 
Page 12  
  ii. Restricting the growth of administra tive burden by ensuring that new 
administrative burden on busine ss caused by a regulatory change3 ("IN") is offset 
by an equal decrease in ad ministrative burden on bu siness from the existing 
stock of regulations ("OUT"). 
49. Departments and agencies must review existing regulations in order to identify 
outdated, burdensome regulations that can be  reformed or removed to offset increases 
in administrative burden  on business arising from  regulatory changes. 
50. "Carve outs" (exceptions) from the scope of the "One-for-One" Rule are as follows: 
i. Regulations that implement non-discretionary obligations; 
ii. Regulations related to tax or tax administration; and 
iii. Regulations that address emergencies or cr isis situations, or that are deemed by 
Cabinet (in this case, the Tr easury Board) to address other unique or exceptional 
circumstances. 
 
(N) Small business lens  
51. Departments and agencies are responsibl e for applying a "small business lens" when 
designing regulations and for being sensit ive and responsive to the burden that 
regulations place on small business. More specifically, as stated in Section 6 (D) 26 (iv), 
(G) 35 (i), (H) 37 (ii) and (iii) of this Directive, departments and agencies are to: 
i. Engage small businesses in alternative a pproaches to compliance, including costs, 
when selecting the appropriate mi x of government instruments; 
ii. When assessing options to maximize net benefits, identify and assess the 
potential positive and negative  impacts on small businesses; 
iii. Demonstrate that the recommended option minimizes the regulatory burden on 
small businesses without compro mising risk protection; and 
iv. Provide a justification for the recommend ed option when ot her less burdensome 
options exist for small businesses. 
 
(O) Forward regulatory planning  
52. Departments and agencies are responsibl e for providing advance public notice of 
regulatory proposals coming forward. This will contribute to a predictable regulatory 
environment for business, Cana dians, and key trading partne rs. Each year, departments 
and agencies are to publish on their webs ites forward regulatory plans that, at a 
minimum, do the following: 
i. Identify and describe expect ed regulatory changes; 
ii. Provide information on planned consultations; and 
iii. Provide departmental contacts  for further information. 
 
(P) Service performance  
53. Departments and agencies are respon sible for maintaining high levels of 
professionalism in their interactions with a ffected Canadians, incl uding businesses, and 
for providing them with cl ear and timely decisions. 
54. Departments and agencies will therefore develop and publish services standards 
that, at a minimum, address th e timeliness of deci sion making. They will also report 
                                                      
3 A "regulatory change" is defined as a new regulation or an amendment to an existing regulation.  G/TBT/2/Add.6/Rev.3 
 Page 13 
 
  publicly on performance against those st andards, particularly for regulatory 
authorizations (e.g., licensing, permits, certifications). 
55. Departments and agencies wi ll also clarify information requirements and the process 
to be followed, including the process for complaints about poor service. 
 
(Q) Reporting  
56. The Treasury Board Secretariat will periodically prepare public reports on progress 
on the government's regulatory priorities. 
 
(R) Review of the Directive  
57. The Directive will be reviewed within five years of its coming into force: 
i. The Regulatory Affairs Sector of the Trea sury Board Secretariat will work with 
departments and agencies to monitor th e implementation of the Directive. 
ii. Departments and agencies are expected to  submit a report to the Regulatory 
Affairs Sector annually on how they have  met the commitments and directions set 
out in the Directive. 
iii. It is expected that the review of the Directive will includ e the involvement of 
interested Canadians. 
 
8. ROLES AND RESPONSIBILITIES  
 
Federal Departments and Agencies  
58. Federal departments and agencies are to: 
i. Comply with this Directive and its operational requirements and guidance, as 
listed on the Treasury Board Secretariat's Regulatory Affairs  website, at all stages 
of the regulatory life cycle. Updated requ irements and guidance will be developed 
as necessary and will be made available to departments and agencies. 
ii. Develop regulatory plans for the coming year(s); and 
iii. Report publicly on plans, priorities, performance, and regu latory reviews in 
accordance with Treasury Board reporting guidelines. 
59. When drafting enabling le gislation, departments and ag encies are to ensure that 
subordinate legislative instruments, including regulations, are subject to the 
requirements of the Statutory Instruments Act . Regulations and other such instruments 
should not be exempted from these requirem ents except in exceptional circumstances, 
when approved by Cabinet. (Requirements governing legislative instruments are set out 
in the Cabinet Directive on Law-making .) 
 
Treasury Board Secretariat  
60. The Regulatory Affairs Sector of the Tr easury Board Secretariat is responsible for 
ensuring that the analysis (on policy and regu latory proposals made or approved by the 
Governor in Council or Treasu ry Board) that is provided by departments, agencies, and 
entities to which this Directive applies is co nsistent with the commitments and directions 
set out in this Directive and that the analysis effectively supports Ministerial decision 
making. G/TBT/2/Add.6/Rev.3 
Page 14  
  61. The Regulatory Affairs Sector is expected to: 
i. Provide advice and guidance to depart ments and agencies concerning the 
development of regulatory proposals and compliance with  the Directive; 
ii. Work with departments an d agencies to provide mi nisters and the Cabinet 
committee responsible for Governor in Council decisions with the necessary 
information to make decisions on the issues before them; 
iii. Review regulatory proposals, challenge departments and agencies on the quality 
of regulatory analyses, and advise them  when the directions set out in the 
Directive have not been met; 
iv. Promote regulatory reform and be a source  of expertise on regulatory analysis, 
management, and governance; 
v. Assess the effectiveness of the Di rective and its implementation. 
62. The Regulatory Affairs Sector will work with other sectors in the Treasury Board 
Secretariat to: 
i. Confirm that regulatory proposals appr opriately address resource management; 
and 
ii. Formulate advice and guidance to departments and agencies on other 
government management policies relevant to their regulatory activities. 
 
Department of Justice  
63. The Department of Justice provides legal advice to departments and agencies on the 
legality of proposals for enabling and subordinate legislation, and the legal requirements 
of the regulatory process. 
64. In doing so, the Department of Justice pr ovides drafting services to departments and 
agencies and, under the Statutory Instruments Act , examines all proposed regulations to 
ensure that they: 
i. Have the necessary legal authorization to be made; 
ii. Are consistent with the Canadian Ch arter of Rights and Freedoms and the 
Canadian Bill of Rights, 1960; 
iii. Are not an unusual or unexpected use of the enabling authority; and 
iv. Are drafted in accordance wi th established standards. 
65. The Department of Justice also provides  departments and agenci es with legal tools 
and advice on the appropriate use of govern ment instruments, regulatory techniques, 
international standards, and compli ance and enforcement techniques. 
66. The Department of Justice and the Legal Bureau of the Department of Foreign Affairs 
and International Trade are responsible fo r advising on the effect of Canada's 
international legal obligations, including their implementation in domestic law. The Trade 
Law Bureau, of the Department of Justice and the Department of Foreign Affairs and 
International Trade, is responsible for advi sing departments and ag encies on Canada's 
trade law obligations. 
 
The Privy Council Office  
67. The role of the Privy Council Office is to assess memoranda to Cabinet and legislative 
proposals with regard to instrument selection, regulatory implications, and consistency 
with this Directive and with the Cabinet Directive on Law-making . It is also responsible  G/TBT/2/Add.6/Rev.3 
 Page 15 
 
  for informing and involving the Regulatory Affairs Sector of the Treasury Board 
Secretariat when policy proposals may have a regulatory aspect. 
68. Under the Statutory Instruments Act , the Privy Council Office  also has a number of 
responsibilities in the regulatory process: 
i. (Examination) Together with the Departme nt of Justice, the Privy Council Office 
examines regulations for any issues with respect to paragraphs 58(i) to (iv) of 
the Statutory Instruments Act  and advises the regula tion-making authority. 
ii. (Registration) Within seven (7) days after making a regulation, the regulation-
making authority transmits copies of the regulation in both official languages to 
the Privy Council Office, which then registers them. The Privy Council Office can 
refuse registration if it deem s that certain sections of the Statutory Instruments 
Act were not followed. 
iii. (Coming into force) As normally regulations come into force the day they are 
registered or later as specified in the regulation, a justification must be provided 
to the Privy Council Office for those that are expressed to come into force earlier 
than the day of registration. 
iv. (Quarterly consolidated index of regulations) The Privy Council Office prepares a 
quarterly consolidated index of all regula tions and amendments to regulations in 
force at any time after the end of the preceding calendar year. 
v. (Revisions and consolidation) The Privy Council Office, after consultation with the 
Deputy Minister of Justice, can ask regu lation-making authorities to revise or 
consolidate regulations. 
 
The Department of Public Works and Government Services  
69. The Canada Gazette Directorate of the De partment of Public Works and Government 
Services is responsible for publishing the Canada Gazette . The Canada Gazette  is the 
official newspaper of the Government of Ca nada for formal public notices, official 
appointments, proposed regulations, regulations, and public Acts of Parliament. It is 
published under the authority of the Statutory Instruments Act  and the Statutory 
Instruments Regulations . 
70. The Canada Gazette  serves as a consultative tool between the Government of 
Canada and Canadians. It gi ves Canadians the opportunity to provide their comments on 
the proposed regulations published in the Canada Gazette , Part I. Anyone who may be 
affected by the proposed regulations can al so request background information from the 
issuing department. 
71. The Canada Gazette Directorate is respon sible for ensuring a rigorous publication 
process and to ensure that strict deadlines are met for the publication of laws, 
regulations, and other statutory instruments. 
 
9. REFERENCES  
72. This Directive is supported by guidel ines, forms and other tools for government 
officials with regard to the regulatory process and associ ated requirements. The most 
recent versions are available on the Treasury Board Secretariat's Regulatory 
Affairs  website. G/TBT/2/Add.6/Rev.3 
Page 16  
   
10. ENQUIRIES AND FURTHER INFORMATION  
73. For more information, please contact Treasury Board Secretariat Public Enquiries , or 
visit the Secretariat's Regulatory Affairs  website.  G/TBT/2/Add.6/Rev.3 
 Page 17 
 
   
11. APPENDIX : INTERNATIONAL TRADE OBLIGATIONS REGARDING 
SPECIFIC REQUIREMENTS FOR THE DESIGN AND 
IMPLEMENTATION OF TECHNICAL REGULATIONS , CONFORMITY 
ASSESSMENT PROCEDURES , AND SANITARY AND 
PHYTOSANITARY MEASURES  
 
74. The Cabinet Directive on Regulatory Management  establishes the responsibility of 
departments and agencies to seek advice an d comply with Canada's international trade 
obligations. This appendix draws attention to certain specific requirements applicable to 
technical regulations, confor mity assessment procedures, an d sanitary and phytosanitary 
measures contained in international agreemen ts to which Canada is a party, including 
the World Trade Organization (WTO) Agreement on Technical Barriers to Trade, the WTO 
Agreement on the Application of Sanitary  and Phytosanitary Measures, and Chapter 
Seven ("Sanitary and Phytosanitary Measures")  and Chapter Nine ("Technical Barriers to 
Trade") of the North Americ an Free Trade Agreement. 
75. In particular, with respect to tec hnical regulations, co nformity assessment 
procedures, and sanitary and phytosanit ary measures that may affect trade, 
departments, and agencies are to: 
i. Specify, where possible, technical re gulatory requirements in terms of 
performance rather than design or descriptive characteristics; 
ii. Consider accepting as equivalent the technical regulations and conformity 
assessment procedures of other countries , even if different, provided they 
achieve the intended regulatory objecti ve and offer an equivalent level of 
assurance of conformity with domestic  technical regulations and standards; 
iii. Ensure that technical regu lations and conformity assessment procedures treat 
products from one jurisdiction no less favourably than like products from other 
jurisdictions; 
iv. Ensure that sanitary and phytosanit ary measures are based on scientific 
principles and evidence, that  they do not arbitrarily or  unjustifiably discriminate 
against other jurisdictions where identical or similar conditions prevail, and that 
they are based on international standard s, guidelines, or recommendations where 
they exist; 
v. Accept the sanitary and phytosanitary measures of other countries as equivalent, 
even if different, provided they achieve Ca nada's appropriate level of sanitary or 
phytosanitary protection; 
vi. Use available international standards, guidelines, and recommendations as a 
basis for technical regulations and for conformity assessment procedures where 
they achieve the intended  regulatory objective; 
vii. Treat regulatees and products from one jurisdiction no less favourably than those 
from other jurisdictions when assessin g conformity to technical regulatory 
requirements, providing they are in comparable situations; 
viii. Have in place a process to review comp laints concerning conformity assessment 
procedures and must take correct ive action when justified; and 
ix. Publish proposals for new or changed technical regulations, conformity 
assessment procedures, and sanitary and ph ytosanitary measures that may affect 
international trade for a comment period of at least 75 days and take into 
account the comments received.