Standards and regulations for a better management of risks Plan of - - PowerPoint PPT Presentation

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Standards and regulations for a better management of risks

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Plan of the presentation

• 1. Standards ≠ Regulations
• Referencing standards in regulations
• Prescriptive regulations
• Performance-based regulations
• 2. Use of standards in policy work
• Implementation
• Non-regulatory tools
• Regulatory cooperation
• 3. Standards and regulations as tools to manage

risks

• n EURASEC

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WP6 on «Regulatory cooperation and std policies»

What we are:

• Intergovernmental body
• Participation by: authorities, regional & int’l org, standards-

setting bodies, business, certification bodies, test houses, civil society

• From all UN Member States
• 1970 – 2010: 40+ years

Our mandate:

•  Standardization  Technical regulations  Conformity

assessment  Accreditation  Metrology  Market surveillance  Risk Management  Education x standards Our activities

• Share info & best practice
• Capacity-building
• Develop and maintain a set of recommendations
• Implement a set of initiatives on specific industrial sectors

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• WP. 6: Five main areas
• f work/strategic priorities
• Enable and empower both Governments and UN

initiatives with a knowledge base as regards standards

Forum for dialogue between UN & standards community

• Remove technical barriers to trade

Sectoral initiatives

• Fight proliferation of counterfeit and non-compliant

goods on the markets

Market surveillance

• Safer and more resilient communities and eco-systems

Risk Management in Regulatory Frameworks

• Bring toolbox of standards to the lay person

Education on standards- related issues

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Plan of the presentation Part 1

• Standards ≠ Technical

Regulations («compulsory specifications»)

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Definitions (WTO)

• Technical regulations: document which lays down

product characteristics (shape, labelling, design, performance etc.) or related processes and production methods with which compliance is mandatory

• Standards: document approved by a recognized

body that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods with which compliance is voluntary

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Standards ≠ regulations

Standards Technical Regulations (compulsory specifications) Developed by standards development bodies Developed by regulatory agencies, by ministries, by parlaments Reasons for development/uptake:

• Access to markets / supply chains
• Lower operational costs
• Increased stability in operations
• Gaining public trust
• Regulations: Help monitor

compliance/ Preempt unfriendly reg. Reasons for introduction:

• Protect communities, the

environment and workers from hazards

• Correct market failures
• Address public concerns

Development Consensus-based process; Publication of draft standards; review of approved standards every 3 or 5 years Development: Consensus-based process; Publication of draft standards; review of approved standards every 3 or 5 years

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Standards ≠ technical regulations

Regulations Examples WTO Appellate Body (EC - Asbestos and EX- Sardines) three part test for determining if a measure is a technical regulation: 1) the document applies to an identifiable product or group of products; 2) the document must lay down one or more product characteristics; 3) compliance with these characteristics must be mandatory. A law stating that only refrigerators that are one meter high can be sold in State X A law stating that all product packaging must be recyclable is an example of a technical regulation. A government guideline saying that all eggs weighing 62 grams or more are entitled to be labelled “Grade A” A guideline defining what products can display a “recyclable symbol” (products that do not bear the symbol may still be sold).

Sardines (EC – Sardines) WT/DS231/AB/R, adopted 23 October 2002, paras. 189-195 Asbestos (EC-Measures Affecting Asbestos- Containing Products), WT/DS135/AB/R, adopted 5 April 2001, paras. 66-70.

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Standards ≠ regulations

Mandatory standards? – for the purposes of WTO – do not exist but… in fact they are widely used!

• China: «GB» standards
• Australia/NZ: Mandatory Product Safety Standards
• n Consumer Products (Baby walkers/ bicycles/

children's nightwear and cots/children' toys/ Cigarette lighters standard)

• US: Electrical code
• APEC: Building codes
• UNECE: World vehicles regulations

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Standards Regulations

Use of standards in regulations

OR ?

Standards ≠ regulations

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Use of standards in regulation

Regulatory authorities should whenever possible make use of international regional and national standards in regulatory work. Regulatory authorities should endeavour to apply “references to standards” methods that respect their voluntary nature

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Methods of reference 1- Exclusive (direct) references

Specific standard quoted by: number and title Avoids reproduction of the standard in the legal text Two forms: dated and undated

Dated direct references: Number, title and date of publication. This can help give legal certainty, assurance and clarity But: Law needs to be changed whenever the standard changes Undated direct references: Number, title but not the date More flexible No update to legal text needed Authority loses its control on reg. instr.

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Methods of referencing 2 – Indicative (or “indirect” reference)

Regulation: Essential Requirements + A clause: Product/process is presumed to comply with the requirements if it conforms to + A list: of applicable international standards that correspond as a whole or partially to the requirements List should be : external to regulatory text / kept up to date/ available to everyone

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Reference to standards

Method Example Direct dated reference The waste hazardous material container shall conform to ISO/DIN/CEN XXXX:2003 TITLE. Direct undated reference The waste hazardous material container shall conform to the latest edition of ISO/DIN/CEN XXXX TITLE Indirect reference Where the product meets the relevant ISO/DIN/CEN standard whose reference number has been published in (REFER TO OFFICIAL LISTING) the relevant authorities shall presume compliance with the requirements of this law. A product shall be presumed safe when it conforms to ISO/DIN/CEN standards, the references of which have been registered on (REFER TO OFFICIAL LISTING).

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Standards and regulations Indicative reference

Prescriptive regulations

Exclusive reference

Performance- based regulations

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• Recent technological developments can be

fed into the national regulatory system

• Efficiency of regulatory work is enhanced
• Ease the burden of compliance for economic
• perators
• Puts responsibility on the individual firm for

meeting a specific target through its own criteria and systems

• “Good regulatory practice”.

Advantage of performance-based reg.

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Plan of the presentation Part 2

• Use of standards in policy

work

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There is more to regulations than a law!

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Use of standards in policy work

• Standards - referenced in regulations
• Are used throughout the system that

supports regulatory implementation

• Standards - support, enhance and help

evaluate policy action: procurement, voluntary certification schemes (e.g. cuts in insurance premiums)

• Standards as the basis of Regulatory

Cooperation

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Use of standards in policy work

Method Example Incentive US: National Flood Insurance Program's (NFIP) offers reasonably priced flood insurance for homeowners of communities that comply with minimum standards for floodplain management. In addition, the Community Rating System (CRS) is a voluntary incentive program for communities that go beyond minimum requirements, entitling homeowners in their communities to cuts up to 45% on insurance Procurement UK: Government Buying Standards (GBS) allow authorities to buy “green “ goods/services Evaluate policy work Emergency Management Accreditation Program (EMAP) to certify state and local emergency management programs against standards such as the Standard on Disaster/Emergency Management and Business Continuity (jointly developed by ANSI – the American National Standards Institute – and the NFPA - National Fire Protection Association).

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Standards for Better and convergent regulations

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Recommendation L

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Recommendation L (continued)

• In sectors of high concern
• Governments define “common regulatory objectives” i.e.

they define legitimate government concerns (public health, safety, protection of the environment, interoperability, etc)

• And agree on how to reach them
• By reference to international standards
• Specifying:

–

how compliance is assessed – which conformity assessment bodies are recognized as competent, – what competence criteria are to be fulfilled –

• ther flanking issues

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Recommendation L

• A set of tools
• Countries can use to harmonize their technical regulations

and regulatory systems in any sector at a regional or global level

• It has also been used to harmonize regulations in all sectors

between two countries or within a customs union

• Builds on the principles of the WTO TBT Agreement but goes

further

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Recommendation L In practice:

• Authorities decide to work together on a specific sector
• They agree on CROs
• They transpose the CROs into national technical regulations
• Then, when products have been assessed in the exporting

country as compliant with the CROs they can automatically be sold in other markets with no further assessment.

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Plan of the presentation Part 3

• Standards and regulations

to address societal risks

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RM in policy work

• The code of Hamurabi prescribed that if

a building collapsed, killing its dwellers, the builder should be executed

• RM is the root of legislative action in

key sectors and in many countries:

• Food safety
• Environmental safety
• Occupational health & safety
• RM is also used throughout the

regulatory system

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Protect safety… promote competitiveness

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Conformity assessment procedures of the new approach : the modules

30

Module

A

Internal control of production

Manu- facturer:

• prepares

technical documen- tation

• declares

conformity with the directive

Module Aa:

Notified body also involved Module

Module

G H

Unit Full verification quality assurance

(EN ISO 9001)

Type examination

Manufacturer:

Notified body:

Module

prepares technical documentation

ascertains conformity of a type

Module Module Module

Manu- facturer:

• prepares

technical documen- tation Notified body:

• ascertains

conformity with the di- rective

Manu- facturer:

• operates a

comprehen- sive QS system

Notified body:

• certifies

QS system

C D E F

Conformity QS QS Product production products verification to type

Manu- facturer

(EN ISO 9002)

Notified

(EN ISO 9003)

Notified Notified body:

• verifies

conformity

• f products

Manu-

body : : body :

• certifies

system Manu- facturer:

• declares

conformity QS

• declares

conformity with the type

• certifies

system

Manu- facturer:

• declares

conformity

QS

facturer :

• declares

conformity

B

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Impact of disasters globally

• Globalization has led to an unprecedented accumulation of risks:
• Global suppy chains: risks ripple across continents
• A lot more value in disaster-prone locations
• Efforts to protect people, infrastructure, the environment & economic activities from

hazards need to be globally cohesive and coherent

• Regulations and standards are historically one of the options available to manage risks

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Impact of disasters – Africa

• 147 recorded disasters including 19

droughts and 67 flood events (2012- 2013)

• Affected millions of people across

Africa and caused 1.3 billion US Dollars in economic losses.

• On average, almost two disasters of

significant proportions have been recorded every week on the continent since 2000

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Africa’s losses are dwarfed by those experienced by other regions

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• Raise awareness of how standards and

regulations help address risks of all kinds

• Develop recommendations on how RM tools

can be used in planning, developing, implementing regulations

• Develop recommendations on how RM can

contribute to the design of the regulatory system and for regulatory cooperation

Goals of UNECE work in RM

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Milestones of the UNECE work on risk management

• International Conference

(Nov. 2009)

• Creation of a group of

experts on Risk Management (Nov. 2010)

• Approval of two

recommendations on Risk Management in Regulatory Systems and Crisis Management in Regulatory Systems (Nov. 2011)

• Launch of the publication

(Nov.2012)

• Participation in the Global

Platform on disaster risk reduction (May 2013)

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UNECE work in RM

• Introduces the concept of risk and

risk management

• Adapts complex RM tools to the

work of authorities

• Presents a novel and holistic

model for managing risks in regulatory frameworks based on international standards (specifically ISO 31000)

• How to, hands on approach with

many examples, case studies, walk through solutions

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The UNECE model

• Setting the objectives of the

regulatory system

• Risk identification
• Risk analysis and evaluation
• Choosing risk treatment strategies
• Implementing risk treatment
• Crisis management
• Monitoring and reviewing

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This process mirrors ISO 31000

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Setting regulatory

• bjectives

 What is the goal of a regulation?  What risks are considered acceptable?  On the basis of what criteria?

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Risk identification

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Risk Assessment

Very low consequences Low consequences Medium consequences High consequences Very high consequences Very low probability Low risk Low risk Low risk Low risk Medium risk Low probability Low risk Low risk Low risk Medium risk Medium risk Medium probability Low risk Low risk Medium risk Medium risk Critical risk High probability Low risk Medium risk Medium risk Critical risk Critical risk Very high probability Low risk Medium risk Critical risk Critical risk Critical risk

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Determination of risk management strategies

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Implementation of a risk management strategy

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Contingency planning

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Conclusions



Risk management is essential for balanced regulations



Can be applied in all sectors



Enhances safety, accountability, economic and social development



Good risk management is good regulatory practice



Enhances institutional mechanisms that allow for structured consultation with business, civil society, professional associations and all key stakeholders



Allows monitoring implementation mechanisms, improve crisis management and monitoring and reviewing

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• Invite you to participate in the Group of

Experts

• Need for capacity-building and awareness

raising activities

• Explore specific sectors and specific

projects where RM principles can be used

• Including horizontal areas, such as

conformity assessment, market surveillance, quality infrastructure..

Invite your participation in

• ur work