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Workshop on Risk analysis in Regulatory Impact Assessment
9, 10 and 11 of June 2014
Ministry of Economy, 30 Alfonso Reyes, Room A
Mexico City, Mexico
BACKGROUND
Since 2008, the OECD Secretariat and the Federal Government of Mexico, through the Ministry of
Economy and the Federal Regulatory Improvement Commission (COFEMER), have been working
together on the “OECD-Mexico initiative to strengthen competitiveness through regulatory
improvement”. As part of this cooperation, several projects have been carried out which have
resulted in improvements to the quality of the regulatory framework and the business environment
of Mexico, amongst them: the electronic one-stop shop for business start-up “tuempresa.gob.mx”;
the update of the Regulatory Impact Assessment (RIA) system, the introduction and implementation
of the Standard Cost Model to simplify formalities and reduce administrative burdens, the first and
second editions of the “OECD Guide to improve formalities at state and municipal level” including
a program of implementation with several Mexican states, and the elaboration of the “OECD
Review of Regulatory Reform for Mexico”.
On 28 of November 2012, the RIA Manual used in Mexico was modified to introduce two
additional types of RIA: High-impact RIA with risk analysis and High-impact RIA with
competition impact and risk analysis. The introduction of these requirements calls for capacity-
building strategies to achieve successful implementation.
Risk-based regulation forms part of a responsive policy process that includes risk assessment, risk
management and risk communication. Risk assessment is a key analytical tool to identify and assess
the extent of a likely hazard and to estimate the probability and consequences of negative outcomes
for humans, property or the environment. Risk management refers to the design and implementation
of actions and remedies to address risks through a consideration of potential treatments and the
selection of the most appropriate course, or combination of courses, of action. Risk communication
is fundamental to the entire risk policy cycle, and assists in identifying the nature and extent of the
risks as well as educating and informing the public about risks when making risk trade-offs.
Improving public understanding of the nature of the risks and the risk management measures can
increase the public acceptance of the risk elements that cannot be reduced through further
management.
The term “risk based regulation” has been used in a number of OECD countries in at least two
contexts: promoting better regulatory design and securing better regulatory compliance and
enforcement. The first application concerns the design of regulations based on a rational scientific
assessment of the consequences of the risk to society that the regulation is intended to avert
The objective of this workshop is to train Mexican federal officials drafting RIAs from ministries
and agencies whose regulations may benefit from undertaking a risk assessment analysis.
2
PROGRAMME
Day 1. Monday 9 of June
Monday 9 of June
Session/Time Title Contents
Registration
8:30 – 8:55 hrs.
Session 1
9:00 – 11:00 hrs.
120min
Opening and introductory remarks.
 Rocio Ruiz, Vice Minister of Competitiveness and Business Standards, Ministry of Economy
 Nick Malyshev, Head, Regulatory Policy Division, OECD
 Virgilio Andrade, Head, Federal Regulatory Improvement Commission (COFEMER)
Roundtable of the importance of risk based regulation.
(7 min. each)
 Alejandro Faya, Head of Unit for the Implementation of Public Policies, Vice-Ministry for
Competitiveness, Mexico
 Rafael Avante, Vice Minister of Labor, Ministry of Labor and Social Welfare
 Carlos Almada, Vice Minister for Transport, Ministry of Transport and Communications
 Manuel Aguilera, President of the Regulatory Agency for Insurance and Bonds (CNSF)
 Carlos Ramirez, President of the Regulatory Agency for Retirement Savings (CONSAR)
 Bernardo Gonzalez, Vice President of the Regulatory Agency for Banking and Stock Exchange (CNBV)
 Cuauhtemoc Ochoa, Vice Minister for Promotion and Regulation, Ministry of Environment
 Enrique Sanchez, Head of the Regulatory Agency for Animal and Vegetable Health (SENASICA)
 Mikel Arriola, Head of the Regulatory Agency for Human Health (COFEPRIS)
Better integration of science, economics, and decision-making has long been a central concern in regulation.
In recent years, a number of organisations, including the OECD, have made recommendations for changing
how these issues are addressed by regulatory agencies.
These recommendations, as well as other proposals and newer ideas for fundamental change, have
significant implications for how environmental and numerous other risks are assessed and regulated.
With a format of a round table, this session will discuss how risk assessment practices have been imbedded
into policy-making and regulation in Mexico and the challenges that remain.
Coffee break
11:00 – 11:30 hrs.
Session 2
11:30 – 13:00 hrs.
90min
Principles of regulation
RIA in the context of regulatory policy and governance
 Delia Vazquez, Policy Analyst, Regulatory Policy Division, OECD
 Manuel Gerardo Flores, Senior Economist, Regulatory Policy
Division, OECD
10 Minutes for Q&A
This session will review the fundamental concepts for regulation and
for RIA, including economic regulation, social regulation, principles of
regulatory policy and governance, main RIA concepts, and main
elements to have a successful RIA system.
presentacion2014_1.pdf
presentacion2014_2.pdf
3
Monday 9 of June
Session/Time Title Contents
Session 3
13:00 – 14:30 hrs.
90min
Principles of risk based regulation
 Nick Malyshev, Head, Regulatory Policy Division, OECD
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University
10 Minutes for Q&A
Risk based approaches are central to regulatory enforcement and
compliance in a number of OECD countries. Such a risk based
regulatory approach can have at least three benefits: 1) It contributes
to regulatory efficiency by targeting the approaches of the regulator to
allocate resources where risk is greatest; 2) it can systematically
improve decision making processes by providing new evidence and
insights into potential risk, and 3) it can assist in providing defensible
rationale for decision making, that can withstand external challenge
from adversely affected parties, the courts, or potentially civil society.
This session will address first the main principles identified by OECD
country experience on risk based regulation, and will go deeper on
the implications this have on RIA, cost benefit analysis, as well as the
role of risk-based decision making in maximizing social welfare.
presentacion2014_3.pdf
presentacion2014_4.pdf
Lunch (break)
14:30 – 16:15 hrs.
Session 4a
16:15 – 16:35 hrs.
20min
The relevance of better regulation on commercial agreements
 Juan Antonio Dorantes Sanchez, General Director for Foreign
Trade Analysis, Ministry Economy
The significant role played by regulatory reform in the context of new
generation trade agreements negotiated by Mexico is to be detailed.
presentacion2014_5.pdf
Session 4b
16:35 – 17:45 hrs.
70min
Embedding risk analysis in RIA in Mexico
 Eduardo Romero Fong, General Coordinator for RIA, COFEMER
 Julio Rocha Lopez, General Coordinator for Regulatory
Improvement of Sectors, COFEMER
10 Minutes for Q&A
Speakers will explain the experience of Mexico in incorporating Risk
analysis in RIA. They will address the risk analysis template in RIA in
Mexico, and present a relevant example and guidance on what is
expected to be answered by regulators.
presentacion2014_6.pdf
presentacion2014_7.pdf
4
Day 2. Tuesday 10 of June
Tuesday 10 of June
Session/Time Title Contents
Session 5
09:30 – 10:30 hrs.
60min
Risk assessment for RIA
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
Topics to be addressed include: what RIA needs from risk
assessment, what is a benefit, definition of different risks (for example
actuarial vs modelled), different values across organizations, science
vs science policy, and introduction to uncertainties amongst others.
presentacion2014_8.pdf
Session 6
10:30 – 11:00 hrs.
30min
Breakout session:
Case study – Identifying potential benefits
The audience will divide in groups of between 10 and 12 people.
The case study will discuss CO2 interventions in order to address key
concepts that include target benefits, risk trade-offs, and outcomes
versus intermediate measures. presentacion2014_9.pdf
Session 7
11:00 – 11:45 hrs.
45min
Actuarial risk assessments
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
The session will focus on the use of data on risk under consideration
for estimating benefits. It will include examples of worker
injuries/fatalities and auto safety measures.
presentacion2014_10.pdf
Coffee break
11:45 – 12:00 hrs.
Session 8
12:00 – 12:45 hrs.
45min
Breakout session:
Case Study - National Highway Traffic Safety Administration
(NHTSA) rear-view RIA
Employing the RIA prepared for regulation of rear-view mirrors, the
audience will identify base case and options, the benefits of the
regulation, and will discuss quantifiable versus non-quantifiable
benefits, using a risk analysis approach.
presentacion2014_11.pdf
Session 9
12:45 – 13:45 hrs.
60min
Modelling human health risks - identifying hazards
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
Speakers will present the role of epidemiology and toxicology in
identifying environmental and occupational risks, as well as sources
of uncertainty in hazard assessment.
presentacion2014_12.pdf
5
Tuesday 10 of June
Session/Time Title Contents
Session 10
13:45 – 14:30 hrs.
45min
Breakout session:
Case Study – Comparing risks
The case study will allow the audience to identify differences between
types of hazards, to define differential uncertainty, as well as to
assess the weight of evidence for different hazards.
presentacion2014_13.pdf
Lunch (break)
14:30 – 16:15 hrs.
Session 11
16:15 – 17:45 hrs.
90min
Estimating consequences - dose response
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
The session will concentrate on how current approaches estimate risk
from environmental and occupational exposures. It will also explain
sources and magnitude of uncertainties. The lack of match that
arises from these exercises to meet needs of RIA will also be
discussed.
presentacion2014_14.pdf
Cocktail – Reception Foyer Ministry of Economy
18:00 hrs.
Day 3. Wednesday 11 of June
Wednesday 11 of June
Session/Time Title Contents
Session 12
09:30 – 10:30 hrs.
60min
Exposure assessment
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
The speaker will explain the main techniques for estimating exposure
to hazards and the importance of matching units to dose-response. presentacion2014_15.pdf
Session 13
10:30 –11:45 hrs.
75min
Characterizing risks
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
The session will address how current risk assessment approaches
characterize risk and uncertainty and how this relates to the needs of
RIA for the characterization of benefits.
presentacion2014_16.pdf
Coffee break
11:45 – 12:00 hrs.
6
Wednesday 11 of June
Session/Time Title Contents
Session 14
12:00 – 13:00 hrs.
60min
Risk perception and communication
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
The audience will learn on how the public thinks about risks and the
challenges in communicating risk information to managers,
legislators, journalists.
presentacion2014_17.pdf
Session 15
13:00 – 14:15 hrs.
75min
Managing risks
 Prof. George Gray, Director of the Centre for Risk Science and
Public Health, George Washington University.
10 Minutes for Q&A
The speaker will explain the different approaches to risk management
tried in US (e.g., technology-based, efficiency based, information-
based) emphasising their advantages and disadvantages in each
case.
presentacion2014_18.pdf
Lunch (break)
14:15 – 16:00 hrs.
Session 16
16:00 – 16:45 hrs.
45min
Case Study - Acrylamide in food
The audience will discuss a case which will help then to understand
when there is a need to respond to a new risk, how a mismatch
between public perception and risk estimates may arise and what
implications this brings about for other cases of risk-based regulation.
presentacion2014_19.pdf
Session 17
16:45 – 17:30 hrs.
45min
Concluding Panel
 Alejandro Faya, Head of Unit for the Implementation of Public Policies, Vice-Ministry for
Competitiveness, Mexico
 Julio Rocha Lopez, General Coordinator for Regulatory Improvement of Sectors, COFEMER
 Nick Malyshev, Head, Regulatory Policy Division, OECD
This concluding session will invite government agency officials from Mexico and OECD countries, the OECD
Secretariat and leading scholars to reflect on the results of the workshop, discuss the implications of the
presentations, and identify the key issues to be addressed in the future.

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Risk Assessment in Regulatory Policy Analysis, Mexico, 9-11 June 2014, Agenda

  • 1. 1 Workshop on Risk analysis in Regulatory Impact Assessment 9, 10 and 11 of June 2014 Ministry of Economy, 30 Alfonso Reyes, Room A Mexico City, Mexico BACKGROUND Since 2008, the OECD Secretariat and the Federal Government of Mexico, through the Ministry of Economy and the Federal Regulatory Improvement Commission (COFEMER), have been working together on the “OECD-Mexico initiative to strengthen competitiveness through regulatory improvement”. As part of this cooperation, several projects have been carried out which have resulted in improvements to the quality of the regulatory framework and the business environment of Mexico, amongst them: the electronic one-stop shop for business start-up “tuempresa.gob.mx”; the update of the Regulatory Impact Assessment (RIA) system, the introduction and implementation of the Standard Cost Model to simplify formalities and reduce administrative burdens, the first and second editions of the “OECD Guide to improve formalities at state and municipal level” including a program of implementation with several Mexican states, and the elaboration of the “OECD Review of Regulatory Reform for Mexico”. On 28 of November 2012, the RIA Manual used in Mexico was modified to introduce two additional types of RIA: High-impact RIA with risk analysis and High-impact RIA with competition impact and risk analysis. The introduction of these requirements calls for capacity- building strategies to achieve successful implementation. Risk-based regulation forms part of a responsive policy process that includes risk assessment, risk management and risk communication. Risk assessment is a key analytical tool to identify and assess the extent of a likely hazard and to estimate the probability and consequences of negative outcomes for humans, property or the environment. Risk management refers to the design and implementation of actions and remedies to address risks through a consideration of potential treatments and the selection of the most appropriate course, or combination of courses, of action. Risk communication is fundamental to the entire risk policy cycle, and assists in identifying the nature and extent of the risks as well as educating and informing the public about risks when making risk trade-offs. Improving public understanding of the nature of the risks and the risk management measures can increase the public acceptance of the risk elements that cannot be reduced through further management. The term “risk based regulation” has been used in a number of OECD countries in at least two contexts: promoting better regulatory design and securing better regulatory compliance and enforcement. The first application concerns the design of regulations based on a rational scientific assessment of the consequences of the risk to society that the regulation is intended to avert The objective of this workshop is to train Mexican federal officials drafting RIAs from ministries and agencies whose regulations may benefit from undertaking a risk assessment analysis.
  • 2. 2 PROGRAMME Day 1. Monday 9 of June Monday 9 of June Session/Time Title Contents Registration 8:30 – 8:55 hrs. Session 1 9:00 – 11:00 hrs. 120min Opening and introductory remarks.  Rocio Ruiz, Vice Minister of Competitiveness and Business Standards, Ministry of Economy  Nick Malyshev, Head, Regulatory Policy Division, OECD  Virgilio Andrade, Head, Federal Regulatory Improvement Commission (COFEMER) Roundtable of the importance of risk based regulation. (7 min. each)  Alejandro Faya, Head of Unit for the Implementation of Public Policies, Vice-Ministry for Competitiveness, Mexico  Rafael Avante, Vice Minister of Labor, Ministry of Labor and Social Welfare  Carlos Almada, Vice Minister for Transport, Ministry of Transport and Communications  Manuel Aguilera, President of the Regulatory Agency for Insurance and Bonds (CNSF)  Carlos Ramirez, President of the Regulatory Agency for Retirement Savings (CONSAR)  Bernardo Gonzalez, Vice President of the Regulatory Agency for Banking and Stock Exchange (CNBV)  Cuauhtemoc Ochoa, Vice Minister for Promotion and Regulation, Ministry of Environment  Enrique Sanchez, Head of the Regulatory Agency for Animal and Vegetable Health (SENASICA)  Mikel Arriola, Head of the Regulatory Agency for Human Health (COFEPRIS) Better integration of science, economics, and decision-making has long been a central concern in regulation. In recent years, a number of organisations, including the OECD, have made recommendations for changing how these issues are addressed by regulatory agencies. These recommendations, as well as other proposals and newer ideas for fundamental change, have significant implications for how environmental and numerous other risks are assessed and regulated. With a format of a round table, this session will discuss how risk assessment practices have been imbedded into policy-making and regulation in Mexico and the challenges that remain. Coffee break 11:00 – 11:30 hrs. Session 2 11:30 – 13:00 hrs. 90min Principles of regulation RIA in the context of regulatory policy and governance  Delia Vazquez, Policy Analyst, Regulatory Policy Division, OECD  Manuel Gerardo Flores, Senior Economist, Regulatory Policy Division, OECD 10 Minutes for Q&A This session will review the fundamental concepts for regulation and for RIA, including economic regulation, social regulation, principles of regulatory policy and governance, main RIA concepts, and main elements to have a successful RIA system. presentacion2014_1.pdf presentacion2014_2.pdf
  • 3. 3 Monday 9 of June Session/Time Title Contents Session 3 13:00 – 14:30 hrs. 90min Principles of risk based regulation  Nick Malyshev, Head, Regulatory Policy Division, OECD  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University 10 Minutes for Q&A Risk based approaches are central to regulatory enforcement and compliance in a number of OECD countries. Such a risk based regulatory approach can have at least three benefits: 1) It contributes to regulatory efficiency by targeting the approaches of the regulator to allocate resources where risk is greatest; 2) it can systematically improve decision making processes by providing new evidence and insights into potential risk, and 3) it can assist in providing defensible rationale for decision making, that can withstand external challenge from adversely affected parties, the courts, or potentially civil society. This session will address first the main principles identified by OECD country experience on risk based regulation, and will go deeper on the implications this have on RIA, cost benefit analysis, as well as the role of risk-based decision making in maximizing social welfare. presentacion2014_3.pdf presentacion2014_4.pdf Lunch (break) 14:30 – 16:15 hrs. Session 4a 16:15 – 16:35 hrs. 20min The relevance of better regulation on commercial agreements  Juan Antonio Dorantes Sanchez, General Director for Foreign Trade Analysis, Ministry Economy The significant role played by regulatory reform in the context of new generation trade agreements negotiated by Mexico is to be detailed. presentacion2014_5.pdf Session 4b 16:35 – 17:45 hrs. 70min Embedding risk analysis in RIA in Mexico  Eduardo Romero Fong, General Coordinator for RIA, COFEMER  Julio Rocha Lopez, General Coordinator for Regulatory Improvement of Sectors, COFEMER 10 Minutes for Q&A Speakers will explain the experience of Mexico in incorporating Risk analysis in RIA. They will address the risk analysis template in RIA in Mexico, and present a relevant example and guidance on what is expected to be answered by regulators. presentacion2014_6.pdf presentacion2014_7.pdf
  • 4. 4 Day 2. Tuesday 10 of June Tuesday 10 of June Session/Time Title Contents Session 5 09:30 – 10:30 hrs. 60min Risk assessment for RIA  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A Topics to be addressed include: what RIA needs from risk assessment, what is a benefit, definition of different risks (for example actuarial vs modelled), different values across organizations, science vs science policy, and introduction to uncertainties amongst others. presentacion2014_8.pdf Session 6 10:30 – 11:00 hrs. 30min Breakout session: Case study – Identifying potential benefits The audience will divide in groups of between 10 and 12 people. The case study will discuss CO2 interventions in order to address key concepts that include target benefits, risk trade-offs, and outcomes versus intermediate measures. presentacion2014_9.pdf Session 7 11:00 – 11:45 hrs. 45min Actuarial risk assessments  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A The session will focus on the use of data on risk under consideration for estimating benefits. It will include examples of worker injuries/fatalities and auto safety measures. presentacion2014_10.pdf Coffee break 11:45 – 12:00 hrs. Session 8 12:00 – 12:45 hrs. 45min Breakout session: Case Study - National Highway Traffic Safety Administration (NHTSA) rear-view RIA Employing the RIA prepared for regulation of rear-view mirrors, the audience will identify base case and options, the benefits of the regulation, and will discuss quantifiable versus non-quantifiable benefits, using a risk analysis approach. presentacion2014_11.pdf Session 9 12:45 – 13:45 hrs. 60min Modelling human health risks - identifying hazards  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A Speakers will present the role of epidemiology and toxicology in identifying environmental and occupational risks, as well as sources of uncertainty in hazard assessment. presentacion2014_12.pdf
  • 5. 5 Tuesday 10 of June Session/Time Title Contents Session 10 13:45 – 14:30 hrs. 45min Breakout session: Case Study – Comparing risks The case study will allow the audience to identify differences between types of hazards, to define differential uncertainty, as well as to assess the weight of evidence for different hazards. presentacion2014_13.pdf Lunch (break) 14:30 – 16:15 hrs. Session 11 16:15 – 17:45 hrs. 90min Estimating consequences - dose response  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A The session will concentrate on how current approaches estimate risk from environmental and occupational exposures. It will also explain sources and magnitude of uncertainties. The lack of match that arises from these exercises to meet needs of RIA will also be discussed. presentacion2014_14.pdf Cocktail – Reception Foyer Ministry of Economy 18:00 hrs. Day 3. Wednesday 11 of June Wednesday 11 of June Session/Time Title Contents Session 12 09:30 – 10:30 hrs. 60min Exposure assessment  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A The speaker will explain the main techniques for estimating exposure to hazards and the importance of matching units to dose-response. presentacion2014_15.pdf Session 13 10:30 –11:45 hrs. 75min Characterizing risks  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A The session will address how current risk assessment approaches characterize risk and uncertainty and how this relates to the needs of RIA for the characterization of benefits. presentacion2014_16.pdf Coffee break 11:45 – 12:00 hrs.
  • 6. 6 Wednesday 11 of June Session/Time Title Contents Session 14 12:00 – 13:00 hrs. 60min Risk perception and communication  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A The audience will learn on how the public thinks about risks and the challenges in communicating risk information to managers, legislators, journalists. presentacion2014_17.pdf Session 15 13:00 – 14:15 hrs. 75min Managing risks  Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University. 10 Minutes for Q&A The speaker will explain the different approaches to risk management tried in US (e.g., technology-based, efficiency based, information- based) emphasising their advantages and disadvantages in each case. presentacion2014_18.pdf Lunch (break) 14:15 – 16:00 hrs. Session 16 16:00 – 16:45 hrs. 45min Case Study - Acrylamide in food The audience will discuss a case which will help then to understand when there is a need to respond to a new risk, how a mismatch between public perception and risk estimates may arise and what implications this brings about for other cases of risk-based regulation. presentacion2014_19.pdf Session 17 16:45 – 17:30 hrs. 45min Concluding Panel  Alejandro Faya, Head of Unit for the Implementation of Public Policies, Vice-Ministry for Competitiveness, Mexico  Julio Rocha Lopez, General Coordinator for Regulatory Improvement of Sectors, COFEMER  Nick Malyshev, Head, Regulatory Policy Division, OECD This concluding session will invite government agency officials from Mexico and OECD countries, the OECD Secretariat and leading scholars to reflect on the results of the workshop, discuss the implications of the presentations, and identify the key issues to be addressed in the future.