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Standards and regulations
for a better
management of risks
Plan of the presentation
1. Standards ≠ Regulations
o Referencing standards in regulations
o Prescriptive regulations
o Performance-based regulations
2. Use of standards in policy work
o Implementation
o Non-regulatory tools
o Regulatory cooperation
3. Standards and regulations as tools to manage risks
o n EURASEC
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+ yearsOur 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
WP. 6: Five main areas
of work/strategic priorities
•Enable and empower both Governments and UN initiatives with a knowledge base as regards standards
Forum for dialogue betweenUN & standards community
•Remove technical barriers to tradeSectoral initiatives
• Fight proliferation of counterfeit and non-compliantgoods on the markets
Market surveillance
• Safer and more resilient communities and eco-systemsRisk Management in
Regulatory Frameworks
•Bring toolbox of standards to the lay personEducation on standards-
related issues
Plan of the presentation
Part 1
• Standards ≠ TechnicalRegulations(«compulsoryspecifications»)
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
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
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.
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
on 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
Standards Regulations
Use of standards in
regulations
OR ?
Standards ≠ regulations
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
Methods of reference 1-Exclusive (direct)
referencesSpecific 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.
Methods of referencing2 – 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
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).
Standards and regulations
Indicative reference
Prescriptive regulations
Exclusive reference
Performance-based
regulations
• Recent technological developments can be fed into the national regulatory system
• Efficiency of regulatory work is enhanced• Ease the burden of compliance for economic
operators • 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.
Plan of the presentation
Part 2
• Use of standards in policywork
There is more to regulations
than a law!
Use of standards in policy work
• Standards - referenced in regulations
• Are used throughout the system thatsupports 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 RegulatoryCooperation
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).
Standards for Better
and convergent regulations
Recommendation L
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 ascompetent,
– what competence criteria are to be fulfilled
– other flanking issues
Recommendation L
• A set of tools
• Countries can use to harmonize their technical regulationsand regulatory systems in any sector at a regional or globallevel
• It has also been used to harmonize regulations in all sectorsbetween two countries or within a customs union
• Builds on the principles of the WTO TBT Agreement but goesfurther
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.
Plan of the presentation
Part 3
• Standards and regulationsto address societal risks
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
Protect safety… promote
competitiveness
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 of 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
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 fromhazards need to be globally cohesive and coherent
• Regulations and standards are historically one of the options available to manage risks
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
Africa’s losses are dwarfed by
those experienced by other
regions
• 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
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 tworecommendations on RiskManagement in RegulatorySystems and CrisisManagement in RegulatorySystems (Nov. 2011)
• Launch of the publication (Nov.2012)
• Participation in the Global Platform on disaster riskreduction (May 2013)
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 holisticmodel for managing risks in regulatory frameworks based on international standards (specifically ISO 31000)
• How to, hands on approach withmany examples, case studies, walk through solutions
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
This process mirrors ISO
31000
Setting regulatory
objectives
What is the goal of a regulation?
What risks are considered acceptable?
On the basis of what criteria?
Risk
identification
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
Determination of risk
management strategies
Implementation of a risk
management strategy
Contingency
planning�
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 structuredconsultation with business, civil society, professionalassociations and all key stakeholders
Allows monitoring implementation mechanisms, improve crisismanagement and monitoring and reviewing
• 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 our work