Implementation Group on Human Biomonitoring

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• Implementation Group on Human Biomonitoring

• Background
• Work by TWG
• National Funders meeting
• Lissabon conference
• Second Recommendation

Ludwine Casteleyn, MD Ministry of the Flemish
Community and University of Leuven, Center for
Human Genetics - Belgium
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Various biomonitoring studies in European
countries
TWG 2003

• total number of questionnaires received 97
• reported budget with 47 questionnaires about 57
  million euro
• about 480 000 children are covered (basis 90
  questionnaires)
• 42 covered heavy metals,
• 25 projects examined asthma or allergies
• 19 projects covered dioxin/PCB exposure,
• 4 covered endocrine disrupters

difficult to compare the data generated
generally not carried out using the
same methodological approach.
For updated inventory see www.hbm-inventory.org
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A more harmonised biomonitoring approach
TWG 2004

• Comparability would contribute to the EU Strategy
  for E H by
• Providing data on distribution of exposure and
  related health impact across Europe
• definition of reference values
• detection of spatial differences in exposure
  (populations/regions at risk)
• detection of temporal differences in exposure
• Providing policy makers with better information
  on control measures to be taken
• Enable more meaningful results of national
  surveys as the number of study subjects involved
  becomes larger
• This would strengthen any observed correlation
  between exposure and health effects, which
  ultimately can point at potential causal
  relationships
• Enable a more effective use of resources by
  shared development of tools and strategies

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TWG 2004
A more harmonised HBM approach

• differences in
• environmental exposures and
• national environmental health concerns,
• different levels of analytical capacities,
• differences in political and health priorities,
• cultural differences, and
• perhaps also different perceptions of ethics
• may render a common biomonitoring survey carried
  out simultaneously in several European countries
  DIFFICULT TO ACHIEVE
• Therefore a step-by-step approach is adopted,

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II. START EU WIDE PILOT PROJECT
TWG 2004

• In view of not complicating the study by major
  analytical problems it is proposed to select a
  pollutant
• for which there is already sufficient analytical
  experience.
• for which the exposure and health relevance is
  well known
• Possible candidates lead and mercury
• in line with a WHO proposal to ensure regular
  biomonitoring of lead (amongst other hazardous
  chemicals) in at risk children.

lead and mercury
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The pilot project is about
..testing the hypothesis that similar procedures
for e.g. recruitment, sampling, data analysis,
quality control can be carried out in different
Member States, yielding comparable results,
providing better information on the relation
between health and environment and better support
for environment and public health policy, at the
national as well as at the international level,
whilst also leading to a more effective use of
resources through shared development of
scientific tools and appropriate
strategies. FEASIBILITY STUDY A common
biomonitoring survey carried out simultaneously
in several European countries
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Problems and deficits
TWG 2004

• Collaboration between disciplines
• Collaboration between disciplines (e.g.
  epidemiologists, toxicologists, molecular
  biologists, paediatricians, oncologists, exposure
  assessors, environmentalists and regulators) in
  order to develop and implement systematic
  biomonitoring systems to produce additional
  useful results for regulatory and/or policy
  decision-making is lacking in many of the
  activities reported.
• Reporting results to the relevant authorities is
  often not foreseen in the research projects at
  hand.

Baseline report on Biomonitoring of Children
in the framework of the European Environment and
Health Strategy (COM(2003)338 final) produced by
the Technical Working Group on Integrated
Monitoring subgroup Biomonitoring of Children -
09 January 2004 http//europa.eu.int/comm/enviro
nment/health/pdf/children_biomonitoring.pdf
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III. Develop tools to translate results into a
response system
TWG 2004

• Scenarios for translation of biomonitoring data
  into a response system require
• integration of biological monitoring data with
  environmental monitoring and health data
• the development of
• reference values to which biomarker results from
  different areas or time periods can be compared
• health based action levels that can help indicate
  when measures need to be taken in order to reduce
  body burden
• A communication plan is an essential part of a
  biomonitoring programme and should be a part of
  the study design.

for most exposure- and effect biomarkers NO
health based values exist
Options for Action for Biomonitoring of
Children in the framework of the European
Environment and Health Strategy (COM(2003)338
final) produced by the Technical Working Group on
Integrated Monitoring subgroup Biomonitoring of
Children - 30 March 2004 http//europa.eu.int/c
omm/environment/health/pdf/040330biomonitoring.pdf

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National Funders meeting November 2005

• Consensus on
• support for Action 3 of the Action Plan to build
  a coordinated approach to HBM in Europe and to
  test the feasibility of this endeavour by a pilot
  project
• the pilot project is in the first place to be
  considered as a tool for building up the
  harmonised approach.
• the development of a harmonised approach and
  consequently the pilot project is a research
  effort in itself

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National Funders meeting November 2005

• No consensus on
• the population to be addressed in the pilot
  study. A majority of MS chooses for a focus on
  children. But other MS prefer a wider view and an
  approach addressing the whole population with
  particular attention to vulnerable groups such as
  children or elderly people.
• the choice of the pollutants to be addressed
• Two main possibilities are suggested
• - a focus on well validated methodologies
  biomarkers for lead - cadmium - methylmercury
• - a focus on newer pollutants that are policy
  relevant and for which a great societal concern
  exists e.g. phtalates

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National Funders meeting November 2005

• Participants agree that decisions should be taken
  urgently to allow the scientific and technical
  preparation of the pilot project by the
  implementation group.
• As no consensus exist on some important aspects
  of the pilot study, the need for a
  decision-making structure / process is raised.

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Lissabon March 2006

• A Conference on the State of the Art on Human
  Biomonitoring in Europe, Lisbon from 19.03.06 -
  21.03.06 organised by the EU-funded ESBIO
  project.
• The Conference brought together providers of HBM
  information in order to improve existing
  information on HBM, to identify expertise and
  institutions that are performing HBM research and
  surveillance activities, to provide a forum for
  discussion of problems in conducting HBM and to
  stimulate exchange of experiences.
• About 100 HBM experts from all over Europe
  listened to more than 40 presentations and
  participated in a poster exhibition.

See http//conference.HBM-inventory.org
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Second recommendation

• In order to advance the process the group made a
  selection of biomarkers to be measured and
  defined a specific study population to be
  monitored. Arguments for these choices are
  included. Further aspects of the protocol are
  indicated in their current preliminary stage.
• The objective of this second IG Recommendation is
  to receive feedback from the Consultative Forum
  and in particular from Member States. This
  feedback will serve as a basis for a more
  detailed protocol and for other steps such as
  calculation of budgets, designing of the
  necessary communication strategy and
  organisational requirements.

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Second recommendation

• Although the SCALE initiative - that is at the
  basis of Action 3 of the EU Environment and
  Health Strategy focussed on children, several
  European Member States prefer a wider view and an
  approach addressing the whole population,
  although with particular attention to vulnerable
  groups such as children or elderly people.
• Collecting samples in mothers (20-40 y) and
  their children (3-15 y.) meets with these
  considerations.

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Second recommendation

• Major criteria to be considered when choosing the
  pollutants to be addressed in the pilot study
  were defined as
• the health significance the known or suspected
  role of the pollutant in the aetiology of
  diseases (serious, frequent, disabling, lethal)
• the known or suspected widespread exposure to the
  pollutant
• the number of countries already measuring the
  biomarker or expressing their interest in doing
  so
• the public health concern
• the availability of a biomarker for which there
  is already sufficient analytical experience
  validated analytical methods with adequate
  sensitivity, specificity, precision reference
  materials and external interlaboratory quality
  assurance systems available
• the availability of healthbased biological
  exposure limits
• biological sample needed readily obtainable in
  the population of concern
• the practicality of storage and transport of
  biological samples
• a small margin of safety between the current
  known exposure and the exposure level which is
  expected to cause adverse health effects
• the knowledge gaps on total exposure
• the policy relevance and the possibility for
  policy actions.

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• PROPOSAL
• For at least one of the following candidates,
  human biomarkers of exposure should be measured
  in all Member States participating in the Pilot
  Project methylmercury, lead, cadmium, cotinine.
• In addition to this, human biomarkers for
  additional substances are recommended, under the
  condition that at least 5 Member States are
  interested in the same biomarker. Additional
  candidate substances so far are phtalates and
  PAHs.

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THE POWER OF HBM

• HBM is an important tool to bring together health
  and environment
• More than classical environmental measurements
  it gets pollution personal!
• Trigger for actions at personal and at societal
  level
• Testing is a message society cares about H E
• Erik Stokstad, Pollution gets personal, News
  Focus article in Science, 3041892-93, 2004.

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• Members of the Implementation Group (IG) on
  Human Biomonitoring (HBM)
• Botsivali Maria, Berglund Marika, Bloemen
  Louis, Boogaard Peter, Canna Michaelidou Stella,
  Cerna Milena, De Felip Elena, Fabianova Eleonora,
  Fréry Nadine, Fucic Aleksandra, Hirvonen Ari,
  Jakubowski Marek, Knudsen Lisbeth, Kyrtopoulos
  Soterius, Lehners Maryse, Levy Len, Reis Fátima,
  Reisner-Oberlehner Martina, Sala Carlo, Schoeters
  Greet, Seifert Bernd, Kolossa-Gehring Marieke,
  Sepai Ovnair, Ten Tusscher Gavin, Van Wijnen
  Joop, Veidebaum Toomas,
• ESBIO project leader Joas Reinhard,
• Chairs Van Tongelen Birgit, Casteleyn Ludwine.