Verso una migliore armonizzazione del biomonitoraggio

umano a livello Europeo: un processo step by step

Towards a more harmonized EU Human Biomonitoring:

a step by step process

Ludwine Casteleyn,MD

University of Leuven, Belgium

COPHES & DEMOCOPHES: L. Casteleyn, M. Kolossa-Gehring, K. Becker, A. Castano, M.

Esteban, J. Angerer, H. Koch, G. Schoeters, E. Den Hond, O. Sepai, K. Exley, L. E. Knudsen,

M. Horvat, L. Bloemen,, A. Joas, R. Joas, A. Katsonouri, I. Lupsa, P. Crettaz, M. Mulcahy, M.

Berglund, P. Rudnai, D. Ligocka, S. Namorado, A. Gutleb, M.Cerna, K. Halzlova, P. Biot, D.

Aerts.

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The Project LifePlus “Womenbiopop”

ISTITUTO SUPERIORE DI SANITÀ

May 20 - 21, 2013

OUTLINE

1. How it began

2. Challenges on the road

3. A EU harmonised protocol

4. First results

5. Ethics, data protection &

communication

6. Next steps

2

THE EUROPEAN ENVIRONMENT AND HEALTH STRATEGY (COM(2003)338 final)

• - reduce disease burden

• - identify and prevent new health threat

• - strenghten EU capacity for policymaking

presents a NEW VISION on how to address environment & health in

an integrated way and puts health in the centre of environment

policy.

TWG Biomonitoring in children (1 of the 9 TWG’s)

ONCE UPON A TIME … 2003

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The European Commission‘s Environment and Health Action

Plan 2004 – 2010, Action 3

Development of a coherent approach to Human Biomonitoring

(HBM) in Europe, in close cooperation with the Member

States

more effective use of resources by shared development of

tools and strategies

more meaningful results of national surveys as the

number of study subjects involved becomes larger

• Need for translation into policy

• Need for adapted communication

strategies

2004

5

• Different approaches • Results not comparable • Communication deficits • Translation to policy

lacking FRAGMENTATION

HBM IN EUROPE

BEFORE

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• Different approaches • Results not comparable • Communication deficits • Translation to policy

lacking FRAGMENTATION

HARMONISATION Comparable results Common guidelines (tested, validated ) Network of competent centers & labs

BEFORE AFTER

HBM IN EUROPE

differences in environmental exposures

national environmental health concerns

analytical capacities

political and health priorities

cultural differences

perceptions of ethics

may render a common biomonitoring survey carried out simultaneously in several European countries difficult to achieve

• a STEP-BY-STEP approach …

TWG

2004

Need for a more coordinated HBM approach

A PILOT STUDY TO

Demonstrate feasibility EU level human biomonitoring

Capacities, networks &

infrastructure

Comparable results

Use of HBM for policy

development across Europe

A STEP-BY-STEP APPROACH….

OUTLINE

1. How it began

2. Challenges on the road

3. A EU harmonised protocol

4. First results

5. Ethics, data protection &

communication

6. Next steps

9

10

DECISION MAKING

EU MS with differences in

•culture

•religion

•language

•environmental health

concerns

•ethical concerns

•technical capacities

•….

• Several disiciplines

• Distinct techical language and

understanding

WHO DECIDES?

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COPHES DEMOCOPHES

FUNDING: 2 PROJECTS! 2009

• WP1: Operational EU HBM framework

• WP2: Sampling and biobanking

• WP3: Analysis and Quality assurance

• WP4: Data analysis

• WP5: Communication

• WP6: Training and capacity building

• WP7: Horizon scanning

• WP8: Support HBM programme

• WP9: Coordination and management

Implementation in 17 countries

Recruitment of 120 children/mothers

Questionnaire information

Samples

(cadmium, phthalate metabolites,

cotinine in urine; mercury in hair;

bisphenol A)

Biobanking

CONSULTATIVE FORUM: Member States, European bodies (EEA, EFSA),

Networks of Regional and Local Authorities Stakeholder: Civil Society, NGO,

Research, Industry and International Organisations (WHO)

IT’S A LONG WAY ….

OUTLINE

1. How it began

2. Challenges on the road

3. A EU harmonised protocol

4. First results

5. Ethics, data protection &

communication

6. Next steps

14

Based on existing experiences, old/current/planned surveys

Ideas and opinions on harmonised approach

Questionnaire round June to September

2010 (NFP, PI, LABs)

Discussions with participating countries’

representatives

• Berlin (September 2010)

• Brussels (October 2010)

• Brussels (February 2011)

.

[

TOWARDS A EU CONSENSUS PROTOCOL

2011 – 2012

7

1

3 4 2

6

8

5

8 8

1. National protocol – Ethics

Start - Aug 2011

2. Recruitment & sampling

Sept 2011 - Feb 2012

3. Chemical analysis samples Jan - March 2012

4. Data analysis & interpretation

March - Sept 2012

5. Communication

Sept - Nov 2012

STEP BY STEP 2011 – 2012

OUTLINE

1. How it began

2. Challenges on the road

3. A EU harmonised protocol

4. First results

5. Ethics, data protection &

communication

6. Next steps

17

IT IS FEASIBLE!

• A common approach to EU HBM was demonstrated

• For the first time comparable data for selected substances were generated

BUT

• Sufficient time is needed

• Funding framework &

• Coordinating & decision making structure are essential

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CONCLUSIONS SO FAR

• Biomarker values showed a large variability in the

population and between the countries

• Exposure of the general population in EU is well below

the current health based guidance values, very few

participants had values which were higher then the

health based guidance values.

• The biomarker levels in children were highly correlated

with the levels in their mother, especially for mercury and

cotinine.

• The information reported by the participants on their

environment and life style allowed to identify factors that

influence the biomarker levels and hence indicate a

leverage for intervention

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• Sufficient harmonization can be achieved to

successfully conduct HBM-studies on a EU scale

• Within a certain frame, adaptations in fieldwork are

possible and do not influence the quality of the common

approach

• Only strict Quality assurance and Quality control will

guarantee comparable and reliable results:

Capacity building should never compromise these strict

criteria for lab selection

• Targetted communication from the very start is key and

must include social science strategies

• Training, helpdesk and telephone conferences were

essential additional tools to guide and maintain the

harmonised approach

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CONCLUSIONS SO FAR

OUTLINE

1. How it began

2. Challenges on the road

3. A EU harmonised protocol

4. First results

5. Ethics, data protection &

communication

6. Next steps

21

RIGHTS OF THE STUDY SUBJECT

RIGHT OF INFORMATION

whether or not the data have been obtained directly from the data subject

• that their personal data are processed and for which purpose

• the identity of the controller

• the purpose(s) of the processing

• the recipients

• the existence of the right of access to data and the right to rectify the data

• How to deal with the ‘right to know’ of the study

participants when the links with health risks, especially at

the individual level, are not well defined?

• How to feed public debate/raise awareness, without

raising unnecessary alarm?

• How to report (uncertainty) to the relevant authorities?

• How to translate results into action?

CHALLENGES FOR COMMUNICATION

WHO POPs SURVEY IN BREAST MILK

• HBM results show that breast milk contains many pollutants

• decrease of body burden mother

• anxious reactions in mothers and in general public.

• Breast-feeding offers

many advantages to

both babies and

mothers: protection for

allergies and sickness;

comfort, physical

closeness, …

Breast-feeding is considered the preferred method of feeding

babies !

Should results be communicated, at individual level, at

population level? How not to overestimate the risks and

downplay the benefits?

Before Sampling

• General Public

• Participants

• Policy & Science leads

• Health professionals

• Schools

• Etc

During sampling

• General Public

• Participants

• Media

Results

• General Public

• Participants

• Policy & Science Leads

• Health Professionals

• Schools

• Etc…

COMMUNICATON TROUGH 3 STAGES OF

THE STUDY

What is cadmium?

Cadmium is a soft, silver to white metal that is naturally present in the Earth’s crust as a mineral in combination with other elements.

Where is it found?

Cadmium can be found naturally in small quantities in the air, water and soil. Higher levels can be found in soil and water near industrial areas or hazardous waste sites. It is also found in tobacco. Most frequently, cadmium is extracted as a by-product during the production of zinc, lead or copper. Cadmium is used in batteries, paint pigments, coatings and platings.

Human Biomonitoring of Cadmium

Cadmium can be measured in both urine and blood. Long-term exposure to cadmium can be measured in urine samples. Cadmium in blood reflects more recent exposure, about 3 months. Finding a measurable amount of cadmium in blood or urine does not necessarily mean that these levels cause an adverse health effect.

Ways to reduce exposure

•Do not smoke tobacco products and limit exposure to second-hand smoke; •Properly dispose of batteries and other cadmium containing products. •Try to avoid eating foods that may contain high levels of cadmium.

How are we exposed?

Environmental exposure to cadmium occurs primarily though smoking. Non-smokers who inhale environmental tobacco smoke (also known as second-hand smoke) take up cadmium as well. The most important source of cadmium for non-smokers is from food (especially shellfish, liver, kidney, wild mushrooms and leafy green vegetables.

How can it affect us?

Long-term exposure to low levels of cadmium through air, water and soil can affect the kidneys and bone density. Breathing in high levels can also damage the lungs but this is more likely to occur in occupational settings rather than in the environment. High levels of cadmium can cause cancer in humans.

Cadmium

Cd

History of risk communication

• All we have to do is get the numbers right

• All we have to do is tell them the numbers

• All we have to do is explain what we mean by the numbers

• All we have to do is show them they’ve accepted similar

risks in the past

• All we have to do is show them that it’s a good deal for

them

• All we have to do is treat them nice

• All we have to do is make them partners

• All of the above

Fischhoff, B., in: Löfstedt en Frewer (1998), p. 133-148

SHARING OF DATA /SAMPLES

RE USING EXISTING DATA AND SAMPLES

Purposes Users

Re use for a new

purpose by other

users

• Go back to study subject

• Assume he/she consented

• Anonymous data or

samples

Defined e.g. in informed consent

OUTLINE

1. How it began

2. Challenges on the road

3. A EU harmonised protocol

4. First results

5. Ethics, data protection &

communication

6. Next steps

29

EU infrastructure and common

approach tested in 17 European

countries

Basic data on the distribution of

specific biomarkers among

defined/selected study population

comparable at a EU scale

Step towards European reference

values

WHAT DID WE EXPECT?

✓

✓

✓

Balancing

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Quality assurance Capacity building

Rigid protocol Flexibility for

feasibity

Central statistical

analysis

National statistical

analysis

Strict

communication

rules

Taking into account

cultural differences

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TOOLS TO BE DEVELOPED

ASAP

• A decision making structure with mandated MS representatives and EU authorities.

• An advisory group of EU experts providing recommendations

• A transparent process to define EU HBM reference and health based values

• A dedicated funding for long-lasting programmes

• Legal instruments or policies that integrate capacities, competences skills, and infrastructure

AFTER THE PILOT STUDY

• At short-term

– To design the outline of a more global EU programme

• At mid-term – To collaborate with other

existing/in development surveys (EHES, INSPIRE)

• At long-term – To assure the continuity of

a EU HBM programme as a policy tool.

232 BIOMARKERS (2009) • Exposure biomarkers for:

» Metals

» Polychlorinated biphenyls, dioxins & furans

» Organochlorine pesticides

» Carbamate pesticides

» Organophosphorous pesticides

» Pyrethroid pesticides

» Herbicides

» Polycyclic aromatic hydrocarbons

» Phthalates

» Phytoestrogens

» Pest repellants

» Cotinine

» Perfluorinated chemicals

» BFRs

» VOCs

» Perchlorate

» Acrylamide www.cdc.gov/exposurereport

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ENV.2013.6.4-1 Assessing individual exposure to environmental

stressors and predicting health outcomes: paving the way for an EU-

wide assessment – FP7-ENV-2013-two-stage

…New approaches relying on the concept of the individual exposome, representing

all environmental contributors to disease received by an individual during a

lifetime, are needed to better understand the underlying mechanisms of

environment-health/disease associations. The aim of the research is to collect

new harmonised and standardised large-scale exposure data from European

populations to improve the quality and comparability of the input data

across countries, with attempts to link individual and population-based

exposure data to health data,… e.g. through a pilot European Exposure and

Health Examination Survey.

Max EU contribution EUR 12 000 000.

Expected impact: …Reduction of fragmentation of exposure data across the EU

and contribution to harmonisation and comparability of data. …

Last call of Seventh Framework Programme February 2013

• Fund research relevant parts in Horizon 2020

• Link HBM to health surveys such as EHES?

• New policy initiatives?

Thank you for listening Ludwine.Casteleyn@med.kuleuven.be

Sincere thanks to the study

participants all to all partners in

DEMOCOPHES & COPHES .

COPHES is funded under the 7th framework

program of the EU (DG Research – No. 244237.

DEMOCOPHES was possible thanks to a joint

financing of 50% from the European

Commission program LIFE+ (DG Environment –

Life09 ENV/BE000410) and 50% from each

participating country.

http://www.eu-hbm.info