Risk Governance and Communication - A Perspective from the NanoSafety Project Team

aquaaniseBiotechnology

Dec 6, 2012 (4 years and 8 months ago)

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KIT


University of the State of Baden
-
Wuerttemberg and

National Research Center of the Helmholtz Association


INSTITUTE FOR TECHNOLOGY ASSESSMENT AND SYSTEMS ANALYSIS (ITAS)

www.kit.edu

Torsten Fleischer

Risk Governance and Communication

A Perspective from the
NanoSafety

Project Team

2


Widening

the

Perspective

EHS
risks

of

nanomaterials

show

three

fundamental
characteristics
:

Complexity:

Cause
-
effect (causal) relationships
(
e.g. application
-
> health
impacts) are difficult to be identified and almost impossible to be quantified,
since many co
-
factors may have an influence

Uncertainty:

Scientific risk assessment
approaches
its limits (characterization
of
noxa

and hazards, measurement problems, variation of reactions on
expositions, indeterminacy and lack of knowledge)

Ambiguity (interpretative and normative):
C
onsequences
of EHS risks can be
judged differently by different persons and groups, regardless of its factual
probability of occurrence

„Risk“:
not only a scientific, engineering or economic concept, but also a
perceptive and communicative phenomenon

Therefore an integrative concept for the societal handling of (technical)
risk is needed that takes all actors and all regulatory systems into
account

| Torsten Fleischer | ITAS | 21.11.2011

4

IRGC Risk
Governance
Framework

Source:

IRGC White Paper 2005

| Torsten Fleischer | ITAS | 21.11.2011

5

Concern Assessment

“is
a social science activity aimed at providing sound insights and a
comprehensive diagnosis of concerns, expectations and perceptions that
individuals, groups or different cultures may link to a hazard.”
(
Renn
/Walker 2008)

Understanding these different concerns, expectations and perceptions is
an important factor

in understanding how individuals and groups perceive and assess risks,

what actions (or non
-
actions) are perceived as being risky for what reasons,

how the different actors in risk management and risk communication are
expected to take action.

Social sciences can contribute to these investigations, applying a broad
set of methods

| Torsten Fleischer | ITAS | 21.11.2011

standardized surveys (telephone, questionnaire, web
-
based, …)

guided or narrative interviews

deliberative formats (focus groups, citizens‘ conferences, …)

content analyses (media; scientific, political or popular texts, …)

6

Data Source:

Special Eurobarometer 341 / Wave 73.1: Biotechnology. Fieldwork Jan/Feb 2010

Citizens

Perspective
: Eurobarometer 2010

St: Nanotechnology is safe for your and your family‘s health.

agree

disagree

don‘t know

EFTA

| Torsten Fleischer | ITAS | 21.11.2011

7

Citizens

Focus Groups


R
ecurring

Themes

Balanced perspective: Positive attitude in general
-

scepticism in detail

Chances: medicine, energy, environment, relief from household routines

Risks / poor acceptance: food, untested products on the market,
‘thoughtless commercialization’, (military applications)

MPN are rarely distinguished from nanotechnology

Oversight: vigilant and acting government, research (and marketing)
under governmental supervision, ‘under control’

Wish for more transparency of governmental and industrial activities

felt able to deal with scientific uncertainties when adequately informed

Overall, didn’t feel well informed


Wish for improvement

Positioning oriented on a consumer perspective

Product information, mandatory labelling, ‘
nano

seal’, independent
product tests, ‘declaration of harmlessness’ by government

Binding force of regulatory instruments


doubts in voluntary measures

| Torsten Fleischer | ITAS | 21.11.2011

8

The
Role

of (
Risk
) Communication

| Torsten Fleischer | ITAS | 21.11.2011

Risk
communication
has
prima facie
two different understandings: as
instrumental or dialogical communication.

In
the process of anticipatory governance of potential EHS risks
of MPN,
dialogical
risk communication
plays the dominant role.

It
should put people that are concerned
in
a position to redeem their
claim to be ‘capable of informed risk appraisal’ by making them
appropriate offers of information, dialogue and participation.

Parliament can
actively contribute to the implementation of risk
communication
measures:

by
encouraging voluntary activities
of communication among stakeholders and between
authorities, stakeholders and the general public

by
making various risk communication measures mandatory in relevant legislative
acts

b
y supporting the provision of credible
information on
nanoproducts

that will
contribute
to consumers’ trust and enable informed
choice

b
y supporting the development of (new)
concepts for such information
provision that
address the concerns of all stakeholders
involved
(e.g. trust
vs.
confidentiality)

9

Definition of
nanomaterials

/ nanoparticles

Risk

Management:
Regulatory

Debates

Regulatory role of harmonized definition

Elements of a definition: Size range covered, functionalities, …

Nanomaterials

in
REACh

(European Regulation of Chemicals)

“Old” or “new” substance

Separate dossiers for
nanomaterials

Reduced quantitative thresholds for registration / evaluation

Regulatory instruments

Labelling

(of consumer products)

Register for
nanoproducts

Tools for preliminary risk assessment

Role and Operationalization of the Precautionary Principle

Nanomaterials

in
sectoral

law

| Torsten Fleischer | ITAS | 21.11.2011

10

Legal
definitions

in
technology

regulation


Legal
definitions of technical
artefacts

in technology regulation

have
to describe the object of regulation sufficiently precise to be clear to
all parties affected by the
regulation
,

have
to consider practices of production and application of the
artefacts
,

h
ave to be
enforceable by the responsible
authorities,

are
usually science
-
based but not necessarily identical to scientific
definition(s) of the same
term
,

will
be shaped by


and in return are shaping


both the
artefacts

that
they intend to describe as well as the contexts in which they are
used
,

thus incorporate
not only scientific and technological knowledge (and its
respective uncertainties), but also
include
the results of policy choices
and political decisions.

| Torsten Fleischer | ITAS | 21.11.2011

11

Numerous proposals for a definition by international organizations,
industry associations, expert committees, …
-

numerous differences

Various institutions called for a harmonized definition of NM

Discussion about the defining features and the respective threshold
values; size, PSD, VSSA, aggregates/agglomerates, properties, …

Definitions vary according to purpose: scientific / regulatory

Regulatory definitions vary by regulatory goals and contexts

Debate about regulatory definitions includes (implicit) regulatory
impact assessment


includes normative aspects, values, economic
interests

Debate about regulatory definition(s) is a political one and has to be
decided by politics, informed by science

European Commission, after public consultation in Fall 2010, published
its recommendation on 18 October 2011

A
Harmonized

Definition
for

Nanomaterials?

| Torsten Fleischer | ITAS | 21.11.2011

12

Two Different Regulatory Paradigms

Reactive

Precautionary

Major players

Most industries,

„innovation“
ministries, (research administration)

CSO,

some TPEA,

„protection“
ministries

Intervention justified

when scientific
evidence of hazard / harm

Intervention already justified when
reasonable abstract

concern

Current regulatory
framework for NM/NT

Mainly

sufficient, only minor
adaptions necessary

Insufficient

for nano specific challenges,
substantial changes needed

Definition of NM

Size between 1


100 nm, higher
upper limit when harm, additional

consideration of PSD and VSSA

Size + certain properties as heuristics,

upper limit 300 nm, reduction possible
in specific regulatory contexts

REACh

Sufficient

after minor adaption,
nanoforms

part of substance dossier

NM as new substances,

own dossiers,
reduced quantity thresholds, additional
information requirements

Labelling

In

l.o.i
., where required, o.k., no
general
nano

label, may be perceived
as warning and confuse customers

Mandatory

labelling for all products
releasing MPN or use them to enable
specific properties

Product register

Use of existing

registers for products
or substances, no general public
register

Semi

public register and notification
requirements for
nano

products, some
content available to consumers

| Torsten Fleischer | ITAS | 21.11.2011

13

A
Preliminary

Risk

Assessment
Heuristic

Probably
hazardous


concern level
high


Criteria:
Exposure occurs; materials have high mobility, reactivity, persistence or
toxicity

Action:
concept for
measures to
minimize
exposure
and/or
to avoid certain
applications

Possibly hazardous


concern level medium


Criteria
:
Exposure cannot be ruled out; materials have unknown agglomeration or
deagglomeration

behaviour
; too little is known about materials' solubility and biodegradability;
the possibilities for release of nanoparticles from matrices have not yet been explored

Action:
concept for
measures to reduce exposure of humans and the
environment

Probably not hazardous


concern level
low


Criteria
:

Exposure can largely be ruled out; materials are soluble or biodegradable; materials
are bound in matrices; materials form stable aggregates or agglomerates

Action:

No
measures in addition to those for "good work safety practice" (or "hygiene
practice") are required

Source: German
NanoCommission

II, February 2011

| Torsten Fleischer | ITAS | 21.11.2011

14

Continue supporting research into EHS aspects of
nanomaterials

Intensify work on ‘orphan’ hazards (routes, endpoints, …)

Consider to make the publication of
nanotoxicological

“no effect”
-
data
data mandatory (especially when gained within publicly funded projects)

(Re
-
)Focus toxicological research on providing orientation and knowledge
for regulatory actions

Support the development of measurement technologies that allow for
characterization, control and enforcement

discuss the future role of (‘the’) harmonized regulatory / legal definition
for
nanomaterials

/ MPN

Work towards an mutually agreed regulatory paradigm for
nanomaterials

Develop options for public information on MNP risks and product
labelling

Support the development of a suitable risk characterization heuristic for
manufactured (particulate)
nanomaterials

Investigate the need for a new regulatory framework for
nanomaterials

Options
for

Risk

Governance

Actions

| Torsten Fleischer | ITAS | 21.11.2011

15

Thank

you

very

much

for

your

attention



Torsten.Fleischer@kit.edu

www.itas.kit.edu

Michael
Decker

Armin Grunwald

Christiane
Hauser

Peter Hocke

Jutta Jahnel

Michael
Reuss

Stefanie
Seitz


| Torsten Fleischer | ITAS | 21.11.2011

16

Backup Slides

| Torsten Fleischer | ITAS | 21.11.2011

17

EU
Recommendation

on Definition
for

NM

1
.

Member

States,

the

Union

agencies

and

economic

operators

are

invited

to

use

the

following

definition

of

the

term

"nanomaterial"

in

the

adoption

and

implementation

of

legislation

and

policy

and

research

programmes

concerning

products

of

nanotechnologies
.



2
.

"Nanomaterial"

means

a

natural,

incidental

or

manufactured

material

containing

particles,

in

an

unbound

state

or

as

an

aggregate

or

as

an

agglomerate

and

where,

for

50

%

or

more

of

the

particles

in

the

number

size

distribution,

one

or

more

external

dimensions

is

in

the

size

range

1

nm

-

100

nm
.

In

specific

cases

and

where

warranted

by

concerns

for

the

environment,

health,

safety

or

competitiveness

the

number

size

distribution

threshold

of

50

%

may

be

replaced

by

a

threshold

between

1

and

50

%
.



3
.

By

derogation

from

point

2
,

fullerenes,

graphene

flakes

and

single

wall

carbon

nanotubes

with

one

or

more

external

dimensions

below

1

nm

should

be

considered

as

nanomaterials
.



4
.

For

the

purposes

of

point

(
2
),

"particle",

"agglomerate"

and

"aggregate"

are

defined

as

follows
:

(a)

"Particle"

means

a

minute

piece

of

matter

with

defined

physical

boundaries
;

(b)

"Agglomerate"

means

a

collection

of

weakly

bound

particles

or

aggregates

where

the

resulting

external

surface

area

is

similar

to

the

sum

of

the

surface

areas

of

the

individual

components
;

(c)

"Aggregate"

means

a

particle

comprising

of

strongly

bound

or

fused

particles
.



5
.

Where

technically

feasible

and

requested

in

specific

legislation,

compliance

with

the

definition

in

point

(
2
)

may

be

determined

on

the

basis

of

the

specific

surface

area

by

volume
.

A

material

should

be

considered

as

falling

under

the

definition

in

point

(
2
)

where

the

specific

surface

area

by

volume

of

the

material

is

greater

than

60

m
2
/cm
3
.

However,

a

material

which,

based

on

its

number

size

distribution,

is

a

nanomaterial

should

be

considered

as

complying

with

the

definition

in

point

(
2
)

even

if

the

material

has

a

specific

surface

area

lower

than

60

m
2
/cm
3
.



6
.

By

December

2014
,

the

definition

set

out

in

points

(
1
)

to

(
5
)

will

be

reviewed

in

the

light

of

experience

and

of

scientific

and

technological

developments
.

The

review

should

particularly

focus

on

whether

the

number

size

distribution

threshold

of

50

%

should

be

increased

or

decreased
.


Source: Commission
Recommendation
2011/696/EU on
the definition of the term “nanomaterial” as adopted on 18th October 2011

| Torsten Fleischer | ITAS | 21.11.2011

18

Recommendation

on Definition

(
4
)

The

definition

(

)

should

be

used

as

a

reference

for

determining

whether

a

material

should

be

considered

as

a

"nanomaterial"

for

legislative

and

policy

purposes

in

the

Union
.

The

definition

(

)

in

Union

legislation

should

be

based

solely

on

the

size

of

the

constituent

particles

of

a

material
,

without

regard

to

hazard

or

risk
.

(

)


(
5
)

The

definition

of

the

term

"nanomaterial"

should

be

based

on

available

scientific

knowledge
.


(
11
)

There

is

no

unequivocal

scientific

basis

to

suggest

a

specific

value

for

the

size

distribution

below

which

materials

containing

particles

in

the

size

range

1

nm



100

nm

are

not

expected

to

exhibit

properties

specific

to

nanomaterials
.

The

scientific

advice

was

to

use

a

statistical

approach

based

on

standard

deviation

with

a

threshold

value

of

0
.
15
%
.

Given

the

widespread

occurrence

of

materials

that

would

be

covered

by

such

a

threshold

and

the

need

to

tailor

the

scope

of

the

definition

for

use

in

a

regulatory

context
,

the

threshold

should

be

higher
.

A

nanomaterial

as

defined

in

this

recommendation

should

consist

for

50

%

or

more

of

particles

having

a

size

between

1

nm



100

nm
.

In

accordance

with

the

SCENIHR's

advice,

even

a

small

number

of

particles

in

the

range

between

1

nm



100

nm

may

in

certain

cases

justify

a

targeted

assessment
.

However,

it

would

be

misleading

to

categorise

such

materials

as

nanomaterials
.

Nevertheless

there

may

be

specific

legislative

cases

where

concerns

for

the

environment,

health,

safety

or

competitiveness

warrant

the

application

of

a

threshold

below

50

%
.



(
16
)

The

definition

(

)

should

not

prejudge

nor

reflect

the

scope

of

application

of

any

piece

of

Union

legislation

or

of

any

provisions

potentially

establishing

additional

requirements

for

those

materials,

including

those

relating

to

risk

management
.

It

may

in

some

cases

be

necessary

to

exclude

certain

materials

from

the

scope

of

application

of

specific

legislation

or

legislative

provisions

even

if

they

fall

within

the

definition
.

It

may

likewise

be

necessary

to

include

additional

materials
,

such

as

some

materials

with

a

size

smaller

than

1

nm

or

greater

than

100

nm

in

the

scope

of

application

of

specific

legislation

or

legislative

provisions

suited

for

a

nanomaterial
.


(
17
)

(

)

the

definition

(

)

should

not

prejudice

the

use

of

the

term

"
nano
"

when

defining

certain

pharmaceuticals

and

medical

devices
.



Source: Commission
Recommendation
2011/696/EU on
the definition of the term “nanomaterial” as adopted on 18th October 2011

| Torsten Fleischer | ITAS | 21.11.2011

19

Further
Observations

Diverse regulatory debate on multiple levels: state governments, national
government(s), European Union, parliaments

Options for action limited for state/national governments since for many
sectors legislative competence lies with European institutions

Most legislative plans shaped by clash of two different regulatory
paradigms
-
> not only within parliaments, but also within administrations

Positions cannot easily be ascribed to classic political camps

A number
decisions blocked so far
-

within and between institutions

Role of European Regulation (and its institutions) for national discourses:
driver as well as protective shield

Missing concepts for adaptive (dynamic) regulation.
Regulation should be
able to react to changes in knowledge or threats in due time

Fading trust
in
self
-
regulation and „soft law“

| Torsten Fleischer | ITAS | 21.11.2011

20

Nanomaterials in
REACh

REACh
: European regulation on production and use of chemical
substances, after 8 years of discussion in force since 2007(?)

“Registration, Evaluation, Authorization and Restriction of Chemicals”

Separate procedures for phase
-
in (“old”) and new substances

For phase
-
in substances, registration procedures (including toxicological
test program) differ by tonnage per year.

Regulatory review in 2012

Phase
-
in substance:
REACh

covers, in principle, also
nanomaterials

of the
same substance. But modifications for NM necessary?

Discussions:

Toxicological data for materials in
nanoform

as part of the registration dossier of the
“mother substance”

Nanomaterials

to be registered as new substance regardless of their chemical
composition

Reduction of tonnage thresholds for
nanomaterials
, additional test parameters

| Torsten Fleischer | ITAS | 21.11.2011

21

The MNP Risk Negotiation Landscape

citizens

environmental

CSO

consumer

CSO

Third
-
party
econ. actors

(chemical)
industry

RTD
management

(bench)
scientists

trade unions

Scientific
committees

regulatory
agencies

ministries for
RTD

ministries for
econom. affairs

ministries for
environment

ministries for
worker protect.

ministries for
consumer prot.

parliaments

general public

industry

science

politics

Stakeholder

fora

as

arenas

for

negotiation

| Torsten Fleischer | ITAS | 21.11.2011

22

Particulate
nanomaterials

(PN)

is an umbrella term for
nanoobjects

with
two or three dimensions on the
nanoscale

(particles,
fibres
, rods, …)

PN is one type of engineered
nanomaterials

that is already used in a
number of applications

There are indications that some PN may pose a thread to human health
and the environment

PN can occur in nature (ash, erosion, salt, …), can be incidentally
produced (fumes, diesel, … ) or
intentionally manufactured (MPN)

Various factors may(!) affect MPN properties: size, shape, surface area,
crystal structure, chemical composition, charge, aggregation properties,
presence of surface coatings, particle number, methods of synthesis, and
many more

These factors may also influence human and eco
-
toxicity

Some MPN are subject of public and regulatory concerns

Manufactured

Particulate

Nanomaterials (
MPN)

| Torsten Fleischer | ITAS | 21.11.2011

23

Polymeric Nanoparticles

(Source:
University of California
-

Santa Barbara)

Representations of Nanotubes
(Source:
nanotechnologies.qc.ca)

TiO
2

Nanoparticles (P25)

(Source:
UNSW Sydney)

Clay Nanosheets

(Source: University of Tokyo
)

TiO
2

Nanotubes

(Source: Yale University
)

Silver Nanoparticles

(Source: ACS
)

ZnO Nanorods

(Source: University of Cambridge
)

Variety

of

Particulate

Nanomaterials

| Torsten Fleischer | ITAS | 21.11.2011

24

Large variety of MPN used or under development, only few studied

High research dynamics: Increased funding of toxicological studies
,
efforts
to review and integrate distributed research
results (meta studies),
but in many cases results still inconclusive

Hazard data
can be reproduced only partially, transferability under
debate

Most studies via inhalation route, poor data on skin and gut
absorption

Substantial lack of measured and modeled exposure data of MPN, for
humans and for the environment

Available methodology is inadequate to measure MPN routinely in various
media (esp. in liquids, biological media, technical matrices)

Results of ‚no effects‘
-
experiments are usually not published

Published interpretations of experimental results, especially those
regarding potential impacts on human health and on the environment,
are still insufficient, contradictory and controversial.

Regulators, citizens, society at large expect answers

Recent

Toxicological

Research Situation

| Torsten Fleischer | ITAS | 21.11.2011