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