integrated monitoring of heavy metals - european commission · environment and health monitoring...

Draft Report on Actions and Recommendations for

Integrated Monitoring of Heavy Metals

under the framework of the European Environment and Health Strategy (COM 2003)338 final)

Produced by the Technical Working Group on Integrated Monitoring

subgroup Integrated Monitoring of Heavy Metals

23th February 2004

Recommendations for Action: Integrated Monitoring of Heavy Metals ii

This report reflects the opinions of the members of the Working Group and it highlights

the different opinions contained within the group where appropriate. It should not be considered as an official statement of the position of the European Commission.

Further information relating to this work is available on the project website: www.environmentandhealth.org or from the Technical Secretariat: Mike Woodfield/Martin Adams AEA Technology Environment Culham Science Centre Abingdon Oxfordshire OX14 3ED United Kingdom Telephone: +44 870 190 6402 Facsimile: +44 870 190 6615 Email: [email protected]

Recommendations for Action: Integrated Monitoring of Heavy Metals iii

Members of the sub-group on Heavy Metals Ivo Allegrini (Chair) Marek Biesiada (Co-chair) Roger Aertgeerts Lars Barregard Giovanni Bidoglio Craig Boreiko Céline Boudet Argelia Castano Natacha Claeys Alexandra Freudenschuss Sophie Gallotti Bernd Gawlik Benoit Hazebrouck Lucia Migliore Franz Nader Staffan Nilsson Adriana Pietrodangelo Bernard Pitié Maria de Fátima Reis Carla Sampaio Gabriele Schoning Anne Steenhout Ivanka Todorova Gavin Tringham Ben Walters Urszula Zielonka DG ENV: Birgit van Tongelen, Claudia Roncancio Pena Technical Secretariat (AEA Technology): Mike Woodfield, Martin Adams

Recommendations for Action: Integrated Monitoring of Heavy Metals iv

Recommendations for Action: Integrated Monitoring of Heavy Metals v

EXECUTIVE SUMMARY This report documents the results of Step 2 of the work of the Heavy Metals Sub-group of the Technical Working Group on Integrated Monitoring (TWG_HM) and is part of the European Commission’s SCALE initiative (Science, Children, Awareness raising, Legal instruments, and Evaluation). In Step 2 the TWG_HM have recommended 5 options for actions that the Commission might adopt as part of an integrated environment and health monitoring and response system for heavy metals. It should be stressed that these are complementary and in no way mutually exclusive. The options have arisen from an analysis of the information collected in Step 1 of the work (see the Baseline Report) and cover the need to:

– Generate synergies and facilitate the sharing of data and methodologies – Increase the understanding of the environment and health relationship – Improve data availability, accessibility, and comparability.

Option 1 outlines a stepwise programme for the generation of harmonised data sets on human exposures to toxic/heavy metals. The objectives are to: improve harmonisation of integrated monitoring & sampling criteria between environmental compartments and extend them to measures of human exposure; improve comparability of data; improve accessibility of data; and facilitate the collection of meaningful information in an environment and health context. Option 2 proposes an expert group to recommend and interpret a biomonitoring programme for the exposure of children to toxic metals. The adverse effects on health from toxic metals in EU children would be estimated using existing data on dose-response relationships collected during the programme. The expert groups would review current national biomonitoring programmes, assess priorities and recommend common activities. An associated pilot study would explore, at the practical level, the possibility of implementing the biomonitoring procedures, and integrating existing databases for application to this programme. Options 3 proposes, within the context of risk communication - education - and training, the establishment of a network for the communication of monitoring data on heavy metals that could cause risks to children’s’ health. Option 4 is a cooperative programme to assess disease burden by monitoring reported heavy-metal specific health outcomes in children. This would be achieved via an expert meeting of public health specialists, a review of available data sets for health outcomes, collaborative effort to make data sets age and gender specific, and piloting a multinational data gathering system. Option 5 details the research work required to better understand the exposure, and effects, on children of toxic metals, metals compounds and mixtures. It also suggests a programme of work to assess ‘new’, hitherto unsuspected, risks.

Recommendations for Action: Integrated Monitoring of Heavy Metals vi

Recommendations for Action: Integrated Monitoring of Heavy Metals vii

CONTENTS

1 INTRODUCTION........................................................................................................1

2 BACKGROUND ..........................................................................................................1

3 PROPOSED OPTIONS FOR ACTION ....................................................................4

4 OPTION ANALYSIS...................................................................................................4

• OPTION 1: STRATEGY AND METHODOLOGY FOR THE GENERATION OF HARMONISED DATA SETS ON HUMAN EXPOSURES TO HEAVY METALS ......................................................5

• OPTION 2A A PROGRAMME FOR SYSTEMATIC BIOMONITORING FOCUSSED ON TOXIC METALS IN CHILDREN ..........................................................................................................5

• OPTION 2B - A PILOT STUDY OF METHYL MERCURY IN PREGNANT WOMEN IN ORDER TO ASSESS THE RISK OF NEUROTOXICITY IN CHILDREN ........................................................6

• OPTION 3- CREATE A NETWORK FOR COMMUNICATION OF MONITORING DATA ON HEAVY METALS THAT POSE A RISK TO CHILDREN HEALTH. ..................................................6

• OPTION 4 ASSESSING THE DISEASE BURDEN BY MONITORING HEAVY-METAL SPECIFIC HEALTH OUTCOMES IN CHILDREN ........................................................................................7

• OPTION 5 – RESEARCH ................................................................................................7

5 ANNEX: REPORTING FORMATS ........................................................................10

• A PILOT STUDY OF METHYL MERCURY IN PREGNANT WOMEN IN ORDER TO ASSESS THE RISK OF NEUROTOXICITY IN CHILDREN ..............................................................................20

• CREATE A NETWORK FOR COMMUNICATION OF MONITORING DATA ON HEAVY METALS THAT POSE A RISK TO CHILDREN HEALTH.............................................................24

• ASSESSING THE DISEASE BURDEN BY MONITORING HEAVY-METAL SPECIFIC HEALTH OUTCOMES IN CHILDREN ...................................................................................................29

• RESEARCH TOPICS - EXPOSURE................................................................................37

• RESEARCH - EFFECTS ................................................................................................41

• RESEARCH – IDENTIFICATION OF NEW RISKS.............................................................46

Recommendations for Action: Integrated Monitoring of Heavy Metals viii

Recommendations for Action: Integrated Monitoring of Heavy Metals 1

1 INTRODUCTION This report documents the results of Step 2 of the work of the Heavy Metals Sub-group of the Technical Working Group on Integrated Monitoring (TWG_HM) as part of the European Commission’s SCALE initiative (Science, Children, Awareness raising, Legal instruments, and Evaluation). The Step 1 Baseline Report represented a snapshot of the work being undertaken by Member States to determine the health impact of metals on human health and to assess the concentrations of metals in various environmental media. It should be noted that a number of EU legal instruments exist which generate information as do various international research programmes operated by the WHO, various UN bodies and others. Step 2 has explored the Options the Commission might adopt to promote an ‘integrated’ environment and health monitoring and response system for heavy metals capable of linking releases of substances, with measured concentrations in various media, with evidence of human exposure, and recorded health effects. The report is structured such that the background gives the details of the work carried out in Step 1 of the work and sets the context within which Step 2 was carried out. The Options for Action are summarised in section 3 and the details are given in the Annex.

2 BACKGROUND The baseline report identified the following requirements:

a) Requirements to combat the deficiencies noted at context level, these relate to rationalising legal instruments to ensure that, wherever possible, they generate data compatible with the concept of integrated monitoring. Work is required to find ‘gaps’ in the reporting obligations on Member States that require either new (or the variation of existing) legal instruments to deliver the missing information. A specific requirement would be the adoption by the Commission and Member States of an Integrated Monitoring Programme able to generate new data and act as a lever on existing programmes. Such a programme should be cost-effective in terms of any additional resourcing required, self-sustaining, and capable of generating consistent, time series, and data over a number of years. It should also be focussed to provide useful information on human exposure and diseases and less on purely environmental endpoints as has sometimes previously occurred. Such a programme could act as the catalyst to bring about the establishment of the multi- functional resource teams needed to challenge existing barriers to multi-media and cross-disciplinary work.

b) A number of technical requirements exist at the information reporting level.

These include the need to:


a) Generate principles and guidelines for randomised heavy metal sampling strategies for multimedia use, and suitable for incorporation in legal instruments, measurement protocols, and standards. An emphasis on data and sampling comparability is therefore required, without any over-burden on data gathering occurring

b) Develop common (or otherwise shared) access to environmental and biological monitoring data.

c) Develop of a family of standards for metals and other contaminants suitable for multi media use in an integrated monitoring context.

d) Develop data quality management and reporting tools.

c) Research actions are specifically required for: • Research into population exposure to metals, and exposure assessment modelling, with a special focus on children including improved knowledge of emission sources including indoor domestic exposure. • Research to define dose-response relationships for low-level heavy metal exposures. These will require innovative work to increase the sensitivity and specificity of traditional methodologies. • Research into increased risk due to genetic susceptibility. • Research into development of non- invasive biomarkers (both exposure and effect) • Harmonised pilot studies, in selected areas, to integrate environmental and biological monitoring. • Research on metals, not included in traditional monitoring programs, for which significant population exposure is anticipated in the future and that may, as a result, cause health problems e.g. metals used in vehicle catalysts: palladium, platinum etc. • Research on the impact of chronic exposure and possible delayed effects, cumulative (time), and synergetic (exposure to complex) exposure.

d) There would appear to be both precedent and opportunity for developing an

integrated environment and health monitoring and response system for heavy metals. More notable missing links, however, are: - A mechanism for the integration of information, methods, existing

programmes and better utilisation of existing data. - A means of focusing on the links between heavy metal environmental

monitoring, with type of exposure, with biomarkers for exposure or to disease monitoring.

As a consequence of the findings of the Baseline report, and using the conceptual framework shown in Figure 1, a number of Options for Action were drawn up using a common reporting format illustrated in Annex 1.


Emissions andsources

Cause - effectrelationships

Extent of HealthProblems

Exposure

Figure 1 – Integrated Monitoring Conceptual Framework

Biomonitoring

In the course of discussion with other TWGs it became clear that a common characteristic of the options was that they fell into one of the category in Fig 2. It should be noted that several of the options proposed bear similarity of form to those of other Technical Working Groups. The TWG Integrated Monitoring Heavy Metal Sub-group, in the time available, were not able to full explore the scope for further consolidation of options with those produced by other TWGs.

Fig 2 Option characteristics

� Options to generate synergies and facilitate datasharing and methodologies

� Options to improve data availability� Options to improve data accessibility� Options to improve data comparability� Options to enhance exchange of information,

communication, co-operation, better use and linkage ofexisting data

� Options with respect to risk communication, trainingand education, information and awareness raising

� Options to develop "preventive" policy� Options to improve public health� Options with respect to research


Figure 3: Options for action identified by the Sub-group on heavy metals

• Option 1 - A Strategy and Methodology for the generation of harmonised data sets on

human exposures to Heavy Metals • Option 2 -

Part a) A programme for systematic biomonitoring focussed on toxic metals in children Part b) A pilot study of methyl mercury in pregnant women in order to assess the risk of neurotoxicity in children

• Option 3 - A network for communication monitoring data on heavy metals that pose a risk to children health.

• Option 4 - A cooperative programme to assess the disease burden by monitoring heavy-

metal specific health outcomes in children

• Option 5 - Research Topics

Part a – Exposure Part b – Effects Part c – Identification of new risks.

3 PROPOSED OPTIONS FOR ACTION

4 OPTION ANALYSIS The options – (see Fig. 3) - arose from an analysis of the information and analysis conducted in the Step 1 of the work, documented in the Baseline report and cover the need, in the context of a European Integrated Environment and Health Monitoring and Response System, to:

– Generate synergies and facilitate the sharing of data and methodologies – Increase the understanding of the environment and health relationship – Improved data availability, accessibility, comparability.

The following summary of the options is intended to indicate what is being suggested, why it is necessary, how action might be taken and the likely elapsed time that action would requiered.


• Option 1: Strategy and Methodology for the generation of harmonised data

sets on human exposures to Heavy Metals

Option 1 describes the development of a Strategy and Methodology for the generation of harmonised data sets on human exposures to toxic/heavy metals. It recommends A step-wise program to:

• supplement the initial data obtained in the Baseline Report, • assess the suitability of the protocols used by member states for specific paediatric

exposure, • assess environmental monitoring strategies to determine whether they provide

information specific to populations at risk of exposure excess (e.g. near point sources),

• generate sampling and analysis protocols and strategies for the guidance of Member States,

• adopt analytical quality control and quality assurance and common data reporting formats,

• undertake a feasibility study into using centralised and decentralised access to the information.

This work is required because there is frequently a lack of comparability and harmonization, in either monitoring procedures, analytical or sampling procedures and/or data reporting, that impedes comparison of data between Member States. Time scales: Extend the Baseline report 1-12 months Propose guidelines for sampling protocols etc 12-24 months Develop analytical quality management systems 24-48 months Undertake feasibility study 24-48 months • Option 2a A programme for systematic biomonitoring focussed on toxic metals

in children

Option 2 proposes an expert group that recommends and interprets a biomonitoring programme for the exposure of children to toxic metals. With the results from such a programme, the adverse effects on health from toxic metals in EU children can be estimated using existing data on dose-response relationships. The expert groups would review current national biomonitoring programmes, assess priorities and recommend common activities. An associated pilot study would explore, at the practical level, the possibility of implementing the biomonitoring procedures, and integrating existing databases for application to this programme. This is an option for creating biomonitoring data that could be used not only for detecting the threats to children’s health and estimating the adverse health effects, but also for evaluating a preventive policy with respect to toxic metals, and their potential sources. If the preventive measures are successful they will improve public health.


The expert group should provide guidance on the generation of information and the management of this information, and for reacting to them with preventive measures in a coordinated way.

This work is required because exposure to toxic metals is a threat to children’s health in certain European populations, and it could be assessed using biological monitoring, which is, however, rarely performed in the EU MS. Time scales: Establishment of the expert group 1-12 months • Option 2b - A pilot study of methyl mercury in pregnant women in order to assess

the risk of neurotoxicity in children

Methylmercury is neurotoxic for the developing brain. This option proposes an EU-wide pilot biomonitoring study for one of the toxic metals. We propose that the pilot study be a study of mercury in hair of pregnant women, and that the commission appoints and supports a European centre to organize this study together with the MS. This is an option for a practical application of uniform biomonitoring that could be used for risk assessment and to develop a preventive policy with respect to methyl mercury. A pilot study of methyl mercury exposure in Europe would facilitate the sharing of methodologies and data between countries. In addition, such a case study would be an option to develop “preventive” policy and improve public health. If advice on reducing the exposure is followed, it will decrease the burden of adverse effects on health from methyl mercury. The method of exposure assessment would be via biomonitoring of mercury in hair of pregnant women but supplemental intake estimates could also be used. The pilot study would estimate the impact of the major source of the exposure (contaminated sea food), and how it could be reduced, in the short and long term. The case study should include as many countries as possible, with the aim of having included all EU MS within 6 years. Yearly reports would be produced, and an open database created. The work is required because few activities are carried out in EU countries with respect to systematic assessment of human exposure to heavy metals. This is in contrast to the more common environmental monitoring activities. Option 2a would encourage concerted action but a practical exercise would be required to refine the detailed procedures to be used. Time scales: Plan and instigate a practical pilot study 12-24 months • Option 3- Create a network for communication of monitoring data on heavy

metals that pose a risk to children health.

This option proposes the creation of a distributed network of Centres, from a variety of Countries, with multi-disciplinary skills, and adequate access to information on monitoring data on heavy metals. The network would facilitate the exchange of information, foster co-operation, and encourage the better use and linkage of existing data. It could handle not only HM but also (if considered feasible and convenient by the Commission) different classes of pollutants (dioxins, endocrine disruptors, etc). The network would be created and steered by a working group who should represent, by mandate, the Member States.


This initiative is needed because there has been no systematic attempt to associate the measured heavy metal concentrations in the environment (and associated exposure) with measures of human health impact (e.g. the risk). Neither does there exist, to the knowledge of the TWG_HM, centres that currently undertake this information exchange role on a routine basis and in a harmonized way. Time scales: Plan and instigate 12-24 months • Option 4 Assessing the disease burden by monitoring heavy-metal specific

health outcomes in children

Steps should be taken to:

1. Convene an expert meeting of public health specialists dealing with heavy metal exposure in a variety of settings (indoor environmental quality, air, water, soil) possibly identified through the networks established by the WHO European Centre on Environment and Health to review the health outcomes, especially those currently being included in national monitoring programmes, in order to identify priorities that could be applied on a Europe-wide basis

2. Review the available data sets (reports) for the priority health outcomes, and compare these datasets against the data management and validation procedures currently applied in international health data management programs such as WHO’s Health-for-All database.

3. Explore possibilities, with the countries, to make the system age and gender sensitive.

4. Try the data gathering system in at least six countries, taking care of equitable geographic distribution and representativeness especially of the children.

This activity is required because the programs investigating the health outcome of one particular metal are not necessarily harmonized amongst the countries of the European region, nor are the data captured in a systematic manner that would allow the comparison of health impact on a Europe-wide basis. Time scales: Plan and instigate 12-24 months • Option 5 – Research

A number of sub-options are proposed, supporting the Option 1-4 above, detailing the work programmes needed to fill the knowledge gaps in our understanding of the exposure, effects, and the identification of new risks posed by toxic metals (not all toxic metals are ‘heavy metals’ in the traditional sense). These include programmes of work to: a) determine the exposure to metals, metal compounds, and metal combinations from:

1. known sources - where they may be included in existing monitoring programs , 2. new sources, or routes, of exposure i.e. catalysts and additives, etc

b) that, • develop new effect assessment methodologies, for various media and exposure vectors,

for metals, particularly soluble forms, (i.e. arsenic, cadmium, nickel, platinum, chromium, palladium, antimony); metal compounds (organ tins, nickel compounds,


Cr+3,+6; As+3,+5); and combination of metals depending on the sources and different medium (for example: platinum & rhodium & palladium in air; mercury & arsenic in fish)

• Innovative work to increase the sensitivity and specificity of traditional methodologies as an aid to the establishment of dose-response relationships for low-level heavy metal exposures.

• Examine the possible effects of chronic exposures. • Determine the increased risk due to genetic susceptibility. • c) develop risk assessment methodologies for metals, metal compounds, and metal combinations from previously unrecognised sources, which are found in the exposure vectors for children. Time scales: Plan and put in place programmes 24 - 36 months


Fig 2 Option characteristics

� Options to generate synergies and facilitate datasharing and methodologies

� Options to improve data availability� Options to improve data accessibility� Options to improve data comparability� Options to enhance exchange of information,

communication, co-operation, better use and linkage ofexisting data

� Options with respect to risk communication, trainingand education, information and awareness raising

� Options to develop "preventive" policy� Options to improve public health� Options with respect to research

Option 2

Option 3

Option 1

Option 4

Option 5

Correspondence of options to Option categories Clearly each option has a number of the characteristics shown in Fig 2 , these are shown in Figure 3.

Fig 3 – Correspondance of options to Option categories


5 ANNEX: REPORTING FORMATS

Option 1 Strategy and Methodology for the generation of harmonised data sets on human exposures to

Heavy Metals

Option for action: Strategy and Methodology for the generation of harmonised data sets on human exposures to Heavy Metals Objectives:

1) Improve Harmonisation of integrated monitoring and sampling criteria on environmental compartments, extended to measures of human exposure,

2) Improve comparability of data, 3) Improve accessibility of data 4) Facilitate the collection of meaningful information in an environment and health context.

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: Environment

Numerous member states currently monitor the presence of heavy metals in different environmental compartments (soil, outdoor air, surface and ground water, drinking water). These monitoring efforts are often in response to regulatory mandates, under the requirements of various obligations from national and community legislation, that are not specific to the assessment of human exposures to heavy metals. However, there is a lack of consistency with respect to the compartments sampled and analysed, the methods used to analyse compartments, and the fashion in which data are reported, facing the problem of harmonising monitoring and sampling methods. Food Routine monitoring underway in many countries, but with variable frequency and using different sampling strategies e.g. individual foods; market basket; diet simulation. Some recent surveys are generating data on specific contaminants in e.g. infant formulae and baby-food but there appears to be less data for age


groups such as 3-11 years. Consumer products Products registries are available in some countries, however overall information is missing.

What is the problem (qualitatively and quantitatively where possible)?: There is frequently a lack of comparability and harmonization, in either monitoring procedures,

analytical and sampling procedures and/or data reporting, that impedes comparison of data between Member States. In addition it has been identified that not all of the information is easily available and there are significant gaps in the matrix of data sets that would enable the linking of substances, with media, evidence of human exposure, and health effects. Even if data are shared and reported to the Commission or other international organisations an evaluation may be problematic. In a number of instances, the environmental compartments measured are not those of highest relevance for the exposure of children. In instances where relevant environmental monitoring may occur, it is most often conducted in the absence of determinations of the impact of environmental contamination upon levels of human exposure. This precludes meaningful synthesis of data for purposes of integrated monitoring of children’s exposures and predictive modelling of relationships between environmental loading and exposure.

Why has the problem arisen?: Monitoring systems have developed historically in context with various tasks and legislative

background. There has not been sufficient harmonisation so far. Environment Results from environmental monitoring in various countries are hardly comparable due to different frequency of sampling, analytical methods, parameters of concern, units, reporting formats and meta information. Moreover international programmes (e.g. ICP Integrated Monitoring) hardly cover HMs monitoring in all compartments (at present air is not included in ICP IM) and anyway only in few cases it is considered mandatory. Monitoring procedures have most often been instituted in response to initiatives that are not specific to the unique exposure vectors that are determinants of human and particularly children exposure to metals. Food. Children have rarely been the focus of attention as the population group at most risk. There is a lack of toxicological information specific to this age and limited data on food consumption habits


to support a risk assessment. Hence sampling has concentrated on the general food supply to support exposure assessments for the average population or for adults. Consumer products. Products registries are available in some countries, however overall information is missing.

General objective in context of a European Integrated Environment and Health Monitoring and Response System: – Generate synergies and facilitate the sharing of data and methodologies – Increase the understanding of the environment and health relationship – Improved data availability, accessibility, comparability – Enhanced exchange of information

this Option will generate synergies and facilitate the sharing of data and methodologies, improved data availability, accessibility, comparability and enhanced exchange of information.

How will the objective be achieved? A step-wise program is suggested wherein: 1) An inventory will be conducted, in order to supplement the initial data obtained in the Baseline Report, which includes

monitoring data, sampling protocols, reporting formats and mandatory data from different Regulations and Directives, available for use by Member States;

2) The suitability of these protocols for specific paediatric exposures will be assessed. Paediatric exposure will vary as a function of the metal of concern and/or the population under study. For example, residential soils and household dusts are the likely predominant exposure source for young children to lead. With aging, food and water sources assume greater importance. In contrast, the cadmium content of agricultural soils (specific to the root zone of plants) will be the primary determinant of dietary cadmium – the predominant source for exposure to this metal;

3) 3 In addition to protocol comparison, environmental monitoring strategies will be assessed to determine whether they provide information specific to populations at risk of exposure excess (e.g. near point sources) or data that defines representative exposures within the EU. Guidance as to sampling appropriate for either purpose should be developed.

4) A set of accepted protocols and strategies should be proposed for guidance of Member State sampling analysis,1 1 1 This may require greater co-operation between the various Technical Working Group in CEN especially:

TC Title Secr Secretary Chairman 230 Water Analysis DIN Mr. W Prufrock Dr. D Anwand 264 Air Quality DIN Dr R Kordeki Mr. P Blinksbje rg


5) Analytical quality control and quality assurance programs are critical. Such programs ensure the accuracy and comparability of data generated from environmental monitoring programs. Under ideal circumstances this can be facilitated by accreditation programs open to access by Member States and the laboratories charged with the conduct of analyses. Implicit in this is the generation and use of a common set of analytical standards and the development of reference materials to both the environmental media and environmental metal concentrations under study.

6) Common data reporting formats should be proposed for aggregated and non-aggregated data. These formats would specify both the format of the data to be presented and the nature of the sampling strategy by which data were collected. Such information would facilitate interpretation and collation of data generated by different Member States.

7) Feasibility study: into using centralised and decentralised access to the information. Main stakeholders affected by the option and how they are affected: MS Regional (subnational) monitoring stations EC and other International bodies

Environment Central and local governments (for funding); landowners and householders (to allow sampling); regulators, industry, NGOs, consumers (use of consequent data). Food Those running representative monitoring programmes e.g. Government (local and central), regulators, academics. Consumer products Industry.

Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial Resource allocations for environmental monitoring would be optimised, particularly in instances

where modifications to existing monitoring programs may increase the relevance and utility of the data generated. In the long-term, data collected would help to target policy and regulatory initiatives on the exposure vectors that make the most significant contributions to children’s exposure.

health Data of greatest relevance to human exposure would be collected, thereby facilitating future health

292 Characterisation of Waste NN Ms. I Krampa-Luitwieter Mr. J Bartels 308 Characterisation of Sludge AFNOR Ms. A-M Feuille Mr. D Andre


assessments and efforts to validate the adequacy of existing regulatory limits. Common access to monitoring data will provide an improved instrument to support decision making. Early warning signals may be easier to detect.

environmental Monitoring of human exposure vectors and exposure levels, as much as environmental exposure pathways of metals, provides additional information regarding sources and intensities of metal emissions.

other costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial Implementation of accreditation programs, and establishment of EU-harmonised analytical

standards, would require centralized support mechanisms and financing. Additional and/or expanded sampling programs would likely be required. The typical cost of developing a CEN Standard through drafting, performance testing, and field demonstration is ~€250K and can take up to 3 years.

health environmental other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Environmental monitoring is currently conducted for a variety of purposes, most of which are not germane to the specific needs of human exposure assessment. However, inferences can be made from these data, and extrapolations made, as to opportunities for human exposure that may exist. Unfortunately, existing extrapolation methods are imperfect and may over- or under-estimate actual exposure. Is further analysis needed?: Yes – but this is implicit in the work program proposed here. What would be the work programme?: An initial assessment of existing Member State programs (Steps 1 – 3 above) would be conducted

over the course of one year. As a function of the needs and opportunities for harmonization revealed by this assessment, Working Groups of Exposure Assessment experts would then seek to develop harmonized guidelines for Member State implementation (Step 4) 2– over the course of a

2 This may require greater co-operation between the various Technical Working Group in CEN especially:


second year. Development of accreditation programs and common analytical standards (Steps 5 – 6) would be a continuing process, the initial phases of which would require up to 48 months to be implemented. The feasibility study (Step 7) could be conducted in parallel to steps 5-6.

What be the working method? : Significant expertise exists in government, industry and academia in the basic issues of analysis

and environmental sampling to be addressed here. Multi-stakeholder panels would provide the optimal way of accessing this expertise. Expert groups should be arranged to review methodologies. Such issues have also been the subject of evaluations by international agencies such as WHO – their involvement could be invited. Finally, some Member States have initiated multi-metallic monitoring programs (e.g. the German Environmental Survey or GeRS program) that would provide insights into the structuring, implementation and resource requirements of efforts to establish representative exposure profiles of the general population. Studies of exposure in the vicinity of existing point sources have also been conducted and can been compared so as to help determine the optimal sampling strategies for this purpose. Recommendations should be disseminated to Member States, academics and NGOs and a legal instrument to drive the process of data collection and availability should be properly developed.

TC Title Secr Secretary Chairman 230 Water Analysis DIN Mr. W Prufrock Dr. D Anwand 264 Air Quality DIN Dr R Kordeki Mr. P Blinksbjerg 292 Characterisation of Waste NN Ms. I Krampa-Luitwieter Mr. J Bartels 308 Characterisation of Sludge AFNOR Ms. A-M Feuille Mr. D Andre


Option 2a A programme for systematic biomonitoring focussed on toxic metals in children

Option for action: The appointment of an expert group to specify a biomonitoring programme for the exposure of children to toxic metals.

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: From the baseline report of the working group on heavy metals it was evident that relatively extensive efforts are spent on environmental monitoring of heavy metals, while human exposure assessment, using biological monitoring, is rarely performed. Integrated monitoring of environment and health is affected by the fact that traditionally the domains of environmental monitoring and monitoring of health status are disjointed, each serving different purposes. It is true that the environment influences human health but there is more to environmental monitoring than only protecting the human population. It is also aimed at protecting the ecosystem, assessing transboundary transfer of pollutants, serving for regulatory purposes, identifying sources of emission etc. Hence the environmental monitoring is, from the very beginning, a holistic approach in which humans are only a (small) part of the problem. It is also a common assumption, although false, that properly defined environmental standards would automatically capture the human health issues. Integrated monitoring could reflect the integration of environment and health (sectors, monitoring efforts, intervention) as well as the integration of various pollutants and/or media. A major achievement in the field of environmental health is the concept of biomonitoring – systematic determination of (properly chosen) biological markers of effect or markers of exposure – e.g. certain substances which can be present in biological material (blood, urine, tissues) only if xenobiotics had been uptaken. In addition, markers of susceptibility are recommended, if there are certain sensitive subgroups that could be identified by biomonitoring of such markers. What is the problem (qualitatively and quantitatively where possible)?: Biological monitoring, is rarely performed in the EU MS, and there is no harmonisation in sampling and analytical procedures/protocols. Biomonitoring may, however, be a valuable method of estimating the effect of toxic metal exposure on health. The latter is especially relevant for children. Lead in blood is a well-known biomarker of lead exposure in children, and there is good knowledge on which levels imply a risk of toxic effects on the central nervous system (brain) in children. The same is true for methyl mercury, which has well-known neurotoxic effects on the developing brain, making pregnant women and their foetuses a suitable


target group for biomonitoring. For cadmium, most attention up to now has been focussed on the toxic effects on the kidney, but some recent research indicates that the developing nervous system may be sensitive to cadmium exposure too. Arsenic exposure through drinking water increases the risk of cancer. The potential health effect of nickel exposure in the general population is sensitisation, with allergic eczema as the adverse outcome. Cadmium, lead, and nickel compounds are also established or suspected carcinogens. Cd may be an endocrine disruptor. The major exposure routes for these toxic metals are diet or drinking water, although for small children, lead in soil and house dust is also important. Many of the other media used for environmental monitoring of metals have little relevance for human exposure. In summary exposure to heavy metals is a threat to health in certain European populations, it could be assessed using biological monitoring, and measures could be taken to reduce the exposure. This is, however, rarely performed in the EU MS. Why has the problem arisen?: As noted above, a true integrated monitoring, focussing also on human health, using biomonitoring, has not been part of the activities in the MS up to now. The reason may be limited knowledge about the potentials of biomonitoring, or an overestimation of the possibilities to draw conclusions about human health from environmental monitoring only. In addition, there has been a reluctance towards the invasive sampling of blood in children. General objective in context of a European Integrated Environment and Health Monitoring and Response System:

– Generate synergies and facilitate the sharing of data and methodologies – Increase the understanding of the environment and health relationship – Improved data availability, accessibility, comparability – Enhanced exchange of information

This option will generate biomonitoring data that could be used when evaluating preventive policies with respect to toxic metals, and their potential sources. If the preventive measures are successful they will improve public health. This option will further facilitate the sharing of methodologies and data between countries. How will the objective be achieved? By:

a) putting in place an expert group who will propose, as part of an integrated E&H monitoring system for all MS, a systematic programme of biomonitoring, focussed on children. Member States should participate according to their own initiative to promote share of experience and to induce, from the beginning, the principle of harmonization.


b) A case study on one of the compounds, methyl mercury, could be started, see option 4b from the working group on heavy metals. An expert group could be asked to propose a programme for systematic biomonitoring of human exposure to toxic metals in Europe, with special focus on children. This expert group could also survey the results and experience gained from the case study on mercury, and assess it in the context of a more extensive programme including also other toxic metals. N.B. Biomonitoring would be a harmonized activity (using standardized data collection and analytical methods) of coordinated determination of biomarkers in susceptible populations like children. It would take into account also the indoor environment, lifestyle, or socio-economic status, which are important while being outside the scope of environmental monitoring practice. The choice of groups targeted for biomonitoring could be either random (or otherwise representative) samples of subjects from the countries’ populations (of children) or similar groups selected because of suspected higher-than-average exposure, e.g. in certain geographical areas. Main stakeholders affected by the option and how they are affected: National EPAs or Environmental Health Agencies. They would be asked to provide data for the expert group in its work to propose a programme for biomonitoring of toxic metals. Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Decrease of adverse effects on health (e.g. neurotoxicity in children) from environmental exposure to toxic metals. The potential benefits, in quantitative terms, are difficult to assess, before the exposure assessment has been performed. If present emissions are important for the exposure and these are decreased, other ecosystems will benefit too. costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Firstly there will be limited costs for the work of an expert group. Secondly, if an extensive biomonitoring programme would be launched, there would be costs for a centre helping the MS with expertise (if needed) for the monitoring activities (estimated at 2 M Euro per year including support to MS), and the costs for performing exposure assessment in the various MS (about 0.3 M Euro per year per MS).


Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Some effects could be achieved by reducing exposure without having assessed it. Most of the knowledge, and methodology sharing benefits would however not be obtained by this alternative approach. Is further analysis needed?: Not for the decision of creating the expert group and instruct it as to their task. If appointed, the expert group would have to assess the situation and propose a more extensive programme. What would be the work programme?: The vision is a European programme using biomonitoring or other kinds of exposure assessment (intake calculations) for the toxic metals lead, mercury, cadmium, arsenic, and nickel in relevant populations in all or most of the MS. What be the working method? : The expert group should provide guidance on the generation of information, and the management of this information, so it could be used for detecting the threats to childrens’ health and for reacting to them with preventive measures in a coordinated way. The programme could include determination of lead in blood in children, mercury in hair of pregnant women, cadmium in urine or blood in various age groups, extended surveillance of arsenic in drinking water, and extended surveillance of nickel in diet as well as (soluble) nickel in common products in contact with human skin, especially in children. The experience gained from the case study on mercury (option 2b from the working group on heavy metals), would be used in the elaboration of proper methods. A more ambitious but optimised programme could include integrated monitoring of mother-child pairs, including umbilical cord blood and several other media. Pooled samples would be an option to reduce costs. The expert group would consider what is feasible and have priority, based i.e. on the experience gathered from a pilot study as indicated in option 2b.


Option 2b

• A pilot study of methyl mercury in pregnant women in order to assess the risk of neurotoxicity in children

Option for action:

Methylmercury is neurotoxic for the developing brain. This option proposes a EU-wide pilot biomonitoring study for one of the toxic metals. We propose that the pilot study be a study of mercury in hair of pregnant women, and that the commission appoints and supports a European centre organizing this study together with the MS.

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: According to our knowledge (Baseline report) few activities are carried out in EU countries with

respect to systematic assessment of human exposure to heavy metals. This is in contrast to the more common environmental monitoring activities. For details, please see option 2a.

What is the problem (qualitatively and quantitatively where possible)?: The environmental data collected can seldom be used for human exposure assessment, see option

2a. Methyl mercury is an example of this problem. It is a neurotoxic metal that negatively affects the developing brain of the foetus and the infant, resulting in impaired cognitive function and thus learning difficulties in school age. This has been established in research in populations exposed to methyl mercury from contaminated seafood. Since the impairment of cognitive function is small, and cognitive function has a ‘normal variability in children, the problem is not possible to survey or quantify by health monitoring. An assessment can, however, be performed based on present knowledge on the relations between exposure (estimated daily dose or mercury concentrations in hair or blood). It is likely that a certain fraction of European pregnant women have too high an intake of methyl mercury, which has a negative effects on the brains of the children they give birth to.

Why has the problem arisen?: The occurrence of potential risks for children from heavy metal exposure has been commented in


option no. 2a. Methyl mercury, is an example of this, and, as for other heavy metals, there has been lack of knowledge of the need for monitoring the exposure, and assess the estimated health effect.

General objective in context of a European Integrated Environment and Health Monitoring and Response System: – Generate synergies and facilitate the sharing of data and methodologies – Increase the understanding of the environment and health relationship – Improved data availability, accessibility, comparability – Enhanced exchange of information

This is an option for a practical application of uniform biomonitoring that could be used for risk assessment with respect to childrens’ health and develop a preventive policy with respect to methyl mercury. A pilot study of methyl mercury exposure in Europe would facilitate the sharing of methodologies and data between countries. In addition, such a case study would be an option to develop “preventive” policy and improve public health. If advice on reducing the exposure is followed, it will decrease the burden of adverse effects on health from methyl mercury.

How will the objective be achieved? The method of exposure assessment would be via biomonitoring of mercury in hair of pregnant women, but supplemental intake estimates could also be used3. The pilot study would estimate the impact of the major source of the exposure (contaminated sea food), and how it could be reduced, in the short and long term. The case study should include as many countries as possible, with the aim of having included all EU MS within 6 years. Yearly reports would be produced, and an open data base created.

Main stakeholders affected by the option and how they are affected: National EPAs or Environmental Health Agencies. They would be asked to provide the data if it is

already there, or otherwise to organize exposure assessments or to assist a European centre for the case study to perform the assessments in the respective countries.

Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or

3 The endocrine disrupter TWG have recommended research, using a mother-child cohort study, for in-utero exposure to endocrine disrupters. This recommendation includes biobanking (including cord blood) and long term follow up. There may, in the future, be a similar research need in the further assessment of heavy metals exposure. Whether heavy metals and endocrine disrupters could be included in the same study or whether they should be separate studies using a comparable protocol has not been discussed in the TWG_HM.


examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial If concentrations of methyl mercury are decreased in certain fish or other food items, this could

result in commercial advantages for the EU vs other parts of the world with respect to trade and/or tourism.

Health Decrease of adverse effects on health (neurotoxicity in children) from environmental exposure to methyl mercury.

Environmental If present emissions are important for the exposure and these are decreased, other ecosystems will benefit too.

Other If successful, the case study methodology could be implemented also for other toxic metals. costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial The costs for a centre (estimated at 1 M Euro per year including support to MS), and the costs for

performing exposure assessment in the various MS (about 0.1 M Euro per year per MS). Health environmental Other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Some effects could be achieved by reducing exposure without having assessed it. Most of the knowledge, and methodology sharing benefits would however not be obtained by this alternative approach. Is further analysis needed?: No. What would be the work programme?: The method of exposure assessment could be either via biomonitoring or via intake estimates. The

case study would estimate the impact of the major source of the exposure (contaminated fish), and how it could be reduced, in the short and long term. The case study would start with a couple of countries, and add new countries every year, with the aim of having included all EU MS within 6 years. Yearly reports would be produced, and an open data base created. The task should be given to a centre in one country, with a yearly budget that permits some support to biomonitoring or other exposure assessment campaigns in the various MS. This centre should also create a network of existing institutions in Europe. Provided funding, the case study could start in January 2005, if financial support is provided. First report in January 2006.


What be the working method? : The task should be given to a centre in one country, with a yearly budget that permits some support

to biomonitoring or other exposure assessment campaigns in the various MS. This centre should also create a network of existing institutions in Europe. Intake estimates for methyl mercury would be performed by combining food consumption surveys, especially in women of child-bearing age, with data on mercury levels in fish and other food items. Possibly also some duplicate diet sampling would be performed. Even better would be biological monitoring of hair mercury levels in pregnant women. Determination of hair mercury levels in randomly selected pregnant women (e.g. consecutively at prenatal care centres) in populations with a potential high intake of methyl mercury would be performed. Experience from this kind of monitoring e.g. from Sweden shows that it works. The two approaches (intake estimates, biomonitoring) could be combined where appropriate. The distribution of results would be combined with existing knowledge on exposure-response relationships as outlined e.g. in the EU commission Position Paper on mercury, or similar reviews by the U.S EPA or by the JEFCA.


Option 3

• Create a network for communication of monitoring data on heavy metals that pose a risk

to children health.

Option for action:

The creation of a network of Centres for communication on HM is an Option seen in view to enhance exchange of information, communication, co-operation, better use and linkage of existing data, not only on HM, but also (if considered feasible and more convenient by the Commission) for different class of pollutants (dioxins, endocrine disruptors...). This option proposes the creation of a network of local Centres, with the geo-political/socio-economic coverage (variety of Countries), multi-disciplinary skills, and adequate access to information on monitoring data on heavy metals.

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: The first objective of TWG-HM as part of the EC’s SCALE initiative was to survey existing

monitoring activities & programmes and to identify any missing links in the promotion of an integrated environmental and health monitoring and response system for heavy metals. Members of TWG-HM were requested to submit information from their respective countries using a reporting format. Even if all the countries represented were able to report information in this way, many members reported difficulties for an adequate access to information (i.e. identifying the right Institution and/or persons to contact) and in getting useful information because often contacted persons wondered why to give such elements to the EC, if they already gave the data in other official ways. Thus the information collection process we have used, due to resource constraints, unavoidably set a priority on certain metals, environmental media, and exposure vectors. Moreover, in most cases, it has not been possible to fill the data set matrix which would be necessary for integrated monitoring. Data gaps exist for substances, media, and exposure vectors between the data sets of various countries and within the data sets of individual countries. Often


Countries/researchers have provided different leve ls of detail in their responses to questions: analytical methodology, geographical/temporal coverage, the set of ‘food’ is better defined in some returns than others, etc.. Finally data collected is a result of variable regulatory compliance and/or ecological risk assessment demands and does not necessarily give adequate coverage to exposure pathways of principal relevance to children. Nevertheless the information collected enabled a comparison of practice within and between countries for a number of metals that pose known health risks (see the Baseline Report produced by the TWG-HM).

What is the problem (qualitatively and quantitatively where possible)?: There are no systematic attempts to associate the measured hm concentrations in the environment

(and associated exposure) with the measures of human health impact (e.g. The risk). Neither do exist, to our knowledge, coordinated centres that could do it in an harmonized way. Some centres may exist, but they have to be identified.there is therefore a need to cut across traditional research boundaries in order to fill data gaps and avoid study bias.

How does this option contribute to the goals of the Strategy ? 1) to the European Integrated Environment & Health Monitoring and Response System :


2) To improve public health with respect to environmental risk factors 3) to the research agenda 4) to raise awareness, to educate

This Option aims to develop (to identify or to create ex novo) a network of Centres under the EC coordination aimed at monitoring of environmental pollutants and human populations at risk,

providing standardization or assays, better diagnostic tools and give a fundamental contribution to design prevention strategies


How will the objective be achieved To accomplish this goal the network will be in need of a coordination with the following tasks:

ensure communication between all Centres, warrant a mechanism for the integration of information, methods, existing programmes and better utilisation of existing data, accomplish the creation of a database, whose implementation and management will be under the coordination of the network. Gather and evaluate relevant news from internal and external sources on a regular basis, produce internal reports with his findings and proposals of research, identify and involve experts as required, set up a web site for periodical reports and exchange of relevant information, establish contacts at national and international level with public and private health organizations dealing with the control of environment, including industries involved in the production of compounds of environmental importance.

Main stakeholders affected by the option and how they are affected: A longer-term advantage to EU Member states and the Commission might be to have a stable

reference for an improved range of policy development tools. Integrated assessment would enable receptor- focussed policies with ‘deliverables/indicators’ suited to a greater public participation in the promotion of environmental sustainability. Such new policy instruments could complement the current generation of industrial source-orientated policies by focussing effort on areas of highest concern, possibly relieving the burden on some industrial sectors, and safeguarding the EU industrial base by reducing the risk of drift of industrial production outside the EU geographical area.

benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial The establishment of the network will facilitate the regular monitoring of environment, and will

conceivably disclose new perspectives by providing adjunctive technologies and mutual supply of specific competences also to other Institutions.


.

Health Possibility to undergo regular monitoring programmes to check health of people living in high-risk regions. Possibility for EU citizens to identify reference centres in their regions to contact for any question related to environment and health

environmental Possibility to undergo regular monitoring programmes to check highly polluted areas. Social The collaboration of scientists with specific competence (biologists, physicians, chemists...),

particularly devoted to this area, should allow the right interaction in order to provide the appropriate tools for specific needs that can arise suddenly (e.g. accidents that can cause heavy environmental pollutions..)

Other The creation of a database available to the community will be of added value Costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial The creation of new Centres could be very expensive and to be considered a long term goal .

However the costs could be lowered in some Countries if the existing Institutions are properly reorganized (see Alternative ways of achieving...)

Health none environmental none Social Possible competition with already existing Institutions with similar or partially overlapping aims Other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. To identify existing Institutions (or laboratories within Institutions) at national level already (even partially) devoted to the monitoring/study of environmental pollutants and their outcome on human population, that could gather into an excellence network with these specific purposes. Is further analysis needed?: A periodic monitoring of the activities of the Centres is however mandatory What would be the work programme?:


The creation of a network of Centres for communication on environment and health issues is seen in view to generate principles and guidelines for different class of pollutants (heavy metals, dioxins, endocrine disruptors...), to design sampling strategies for multimedia use, and suitable for incorporation in legal instruments, measurement protocols, and standards, to develop common (or otherwise shared) access to environmental and biological monitoring data, to develop of a family of standards for metals and other contaminants suitable for multi media use in an integrated monitoring context, to develop data quality management and reporting tools.

What be the working method? : Firstly the creation of an expert working group (composed by members belonging to the EC, who

should represent, with a mandate, the Member States), that can identify the best ways to reach the goal, which is to set up a network of local centres, with the geo-political/socio-economic coverage (variety of countries), multi-disciplinary skills, or adequate access to information and a financial budget for the purpose. A periodic monotoring of the reported activities will be carried out subsequently by the same working group members.


Option 4 • Assessing the disease burden by monitoring heavy-metal specific health outcomes in children

Comment

What is happening now

On Food:

-EU DG Research: SCOOP research projects -WHO: The Global Environment Monitoring System / Food Contamination Monitoring and Assessment Programme (GEMS/Food) in Europe is compiling data on food contamination and human exposure for global synthesis, evaluation and dissemination. The GEMS/Food Europe comprehensive list of contaminants and food commodities includes Heavy Metals, dioxin and dioxin like PCBs, and other contaminants http://www.euro.who.int/foodsafety/Chemical/20020816_7

Lead Milk, canned/fresh meat, kidney, fish, molluscs, crustaceans, cereals*, pulses, legumes, canned/fresh fruit, fruit juice, spices, infant food, total diet, drinking water

Cadmium Kidney, molluscs, crustaceans, cereals*, flour, vegetables, total diet

Mercury Fish, fish products, mushrooms, total diet

Inorganic arsenic Drinking water

Since 2001 the activities of GEMS/Food Europe have been promoted in coordination with monitoring activities of other UN agencies and particularly considering the monitoring efforts of the European Commission. GEMS/Food is promoting the use of the Operating Programs for Analytical Laboratories software OPAL I, II for the collection and collation of data on food contamination in a



Comment

harmonized way to optimize the use of the database for exposure assessment at the international level. GEMS/Food Europe has been providing training on Total Diet Studies to accession countries in 2002 and particularly on the use of OPAL I, II to the Baltic countries in 2003. Access to the GEMS/Food databases on contaminants in individual foods and the total diet is available through SIGHT (Summary Information on Global Health Trends): http://sight.who.int/" On water: A revision of the WHO Drinking Water Quality Guidelines has taken into account new toxicological insights for a number of heavy metals. The EU drinking water directive (80/778/EEC) and its successor (98/83/EC) operationalise many of these guidelines. Nevertheless, problems remain. For example, in France, Belgium and other countries extensive replacement of lead pipes is still required, a situation not dissimilar to problems in the new EU member states. In the UK, the use of lead solder is still common, although officially illegal since 1987. In some of the accession countries, there are also problems with othe r metals such as nickel in the Czech republic, cadmium in the Slovak republic, and As in certain locations in Hungary and in the Baltic states. 5.1.1.1 On air

Several international arrangements, particularly UNECE Conventions (CLTRAP) address the emission of toxic metals and aim to reduce to 1990 levels the emissions of Cd, Pb and Hg. Specific problems remain with Hg, where international action is being called for by UNEP to



Comment

limit reduce the risk to human health from Hg originating from combustion practices.

Current problem Health impacts of heavy metals are recognized in the scientific literature both for acute as well as for chronic exposure. A significant amount of data has been gathered from industrial exposure data; data from accidental intoxication or chronic exposure are relatively scarce but have nevertheless been taken into account in the work of for example the IPCS.

For two of the priority heavy metals, As and Pb, drinking water has been recognized as an important exposure pathway. As contamination historically constituted a major problem in certain countries (Hungary) and continues to challenge other supply systems. In young children, contaminated milk has been described as one important pathway. Pb remains especially important to urban water supplies in older dwellings, places where also in-house air quality may be affected by the use of lead. The FAO/WHO Joint Expert Committee Food Additives and Contaminants (a risk assessment body of Codex) reduced by half the PTWI for methyl mercury which now raises some sensitive questions about risk advice. With the new limit, both children and women are going over the PTWI with rather modest consumption of fish that contain 0.5 ppm. Furthermore, marine mammals contain even higher levels. WHO and FAO plan to develop general guidance for such risk-benefit considerations, with the contamination of fish as case studies. Health outcomes of metal exposure The EEA, in its report to the Environment for Europe Conference (Kiev, 2003), identified a number of major health impacts and some associations with the exposure to chemicals:

- Cancer: Cd, Cr - Cardiovascular diseases: Pb



Comment

- Skin diseases: Ni, As - Reproductive dysfunctions: Cd - Developmental disorders: Cd - Nervous system disorders: Pb

Some of these health outcomes are difficult to attribute unequivocally to the presence of one specific metal, such as cancers, while others have a health outcome that is uniquely liked with the metal, i.e. arsenical keratosis, saturnism are specific to one metal. Countries in which these problems occur have developed targeted monitoring programs on the health of the population. In such cases, often biomarkers are being used such as Pb in blood, protein in urine samples etc. so the available dataset is often broader than the mere health outcome. However, the programs investigating the health outcome of one particular metal are not necessarily harmonized amongst the countries of the European region, nor are the data captured in a systematic manner that would allow the comparison of health impact on a Europe-wide basis.

Why has the problem arisen

Current monitoring programs, such as the WHO Health-for-All database, capture data, which are relevant to health issues recognized to be national priority concerns on a region-wide basis. Such concerns are at present predominantly micro-biologically oriented. The existing monitoring and data management programs are not designed to capture health impact of heavy metals, although their structure could be adapted to serve this purpose.



Comment

1. General objective in the context of the European Integrated Environment and Health Monitoring and Response System

Generate synergies and facilitate the sharing of data and methodologies:

Increase the understanding of the environment and health relationships:

Improved data avilability, accessibility, comparability:

Enhanced exchange of information

2. To awareness raising, information:

3. To promote integrated monitoring by generating health data

- exposure data

- supporting information and tools

Justification Information on the current health impact of heavy metals, especially chronic exposure, is essential for a better understanding of the burden of disease, the elucidation of different pathways, and the development of appropriate policy measures, especially in ‘hot-spots’

Furthermore, in line with the other proposals of the TWG_HM, a region-wide database on the current health information of heavy metal impact would be an important tool to site the location of pilot studies

How the objectives will be achieved The following steps will be undertaken:

Convene an expert meeting of public health specialists dealing with heavy metal exposure in a variety of settings (indoor environmental quality, air, water, soil) possibly identified through the networks established by the WHO European Centre on Environment and Health



Comment

to review the health outcomes, especially those currently being included in national monitoring programmes, in order to identify priorities that could be applied on a Europe-wide basis

Review the available data sets for the priority health outcomes, and compare these datasets against the data management and validation procedures currently applied in international health data management programs such as WHO’s Health-for-All database.

Explore possibilities, with the countries, to make the system age and gender sensitive.

Try the data gathering system in at least six countries, taking care of equitable geographic distribution and representativeness especially of the children.

Main stakeholders affected by the option - Ministries of health, environment, labor (for occupational exposure)

- International health data management centers

- General public/civil society

- International agencies EC, European Food Safety Authority WHO, EEA

Benefits, advantages

- economic - Endpoint determination will improve understanding of the economic impact of especially chronic exposure to heavy metals

- social - Chronic exposure to heavy metals impacts disproportional on women and children. Insight in the current burden of disease and exposure routes will be an essential evidence base for the formulation of corrective measures



Comment

- health - Reduction of the burden of disease caused by, especially chronic, exposure to heavy metals.

- environment - Better information in the pathways through which heavy metal exposure occurs will allow targeted intervention through emission norm setting, etc.

Costs, disadvantages

- economic Costs would be:

Initial meeting of European environmental epidemiologists and clinical chemists

Consultancy contract to gather information and assess current monitoring programs

Test case with automated data gathering, validation, and capture in at least three countries with significantly different levels of economic and environmental development

- social There are no social disadvantages to the proposed action

- health There are no health disadvantages to the proposed action

-environmental There are no health disadvantages to the proposed action

Alternative ways of achieving the same contribution

- Is further analysis needed The proposed action could be undertaken by any data management center used to work at a regional level. However, besides the computational capacity, the center will also need to have experience



Comment

with the qualitative evaluation of medical data.

- What would be the workplan

- What would be the working method


Option 5a

• Research Topics - Exposure

Option for action: Research on exposure assessment models

A programme of work to determine the exposure to metals, metal compounds, and metal combinations from:

a) known sources - where they may be included in existing monitoring programs , b) new sources, or routes, of exposure i.e. catalysts and additives, etc

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: There is a great deal of reactive heavy metal monitoring information arising from data reporting

obligations in exitant legal instruments, many of these regulate emissions from industrial installations, vehicles, and consumer products etc and give greater protection to populations already known to be at risk. There is little available models to determine potential actual exposure of some metals (or combinations), and/or exposure vectors. Numerous member states currently monitor the presence of heavy metals in different environmental compartments. These monitoring efforts are often in response to regulatory mandates that are not specific to the assessment of paediatric exposures to heavy metals

What is the problem (qualitatively and quantitatively where possible)?: There is little monitoring data that reflects the more general metal(s) exposure of the general

population4, such as data on indoor air quality. or the media that provide the exposure routes for children (e.g. urban garden soil and dust) In Food, for example, sampling strategies may not be adequate to represent the foods most commonly eaten by children or which may be providing the greatest exposure by children to environmental contaminants. In addition exposure models strategies will often illustrate short-term or acute exposure, whereas the health effects to general population that are most likely to occur

4 N.B. this is the research requirement associated with the gernral requirement specified in Option 1.TGW-HM


from long-term, chronic, exposure. Health effects may be evident many years after exposure and there is no ability to link current health effects with past exposure. In a number of instances, the environmental compartments measured are not those of highest relevance for the exposure of children. In instances where relevant environmental monitoring may occur, it is most often conducted in the absence of determinations of the impact of environmental contamination upon levels of human exposure. This precludes meaningful synthesis of data for purposes of integrated monitoring of children’s exposures and predictive modelling of relationships between environmental loading and exposure.

Why has the problem arisen?: Children have rarely been the focus of attention as the population group at most risk. There is a

lack of toxicological information specific to this age and limited data on food consumption habits to support a risk assessment. Hence sampling has concentrated on the general food supply to support exposure assessments for the average population or for adults.

General objective in context of a European Integrated Environment and Health Monitoring and Response System: – Generate synergies and facilitate the sharing of data and methodologies

XXX Increase the understanding of the environment and health relationship – Improved data availability, accessibility, comparability – Enhanced exchange of information

The research programme will develop new and/or strengthen existing exposure assessment

modelling, with a special focus on children. The programme should aim to improve knowledge

of emission sources and exposure routes, including indoor domestic exposure, for:

o Inmediate Hg, Pb, Cd

o medium term As, Ni, speciatium.

o Long-term Sn, Sb,Cr,Tl, Pt, Pd, Rh,Se[Cu Zn,Fe]

Exposure models will, take into account bioavailability (for eample bioavailability of seafood-Cd and soil- Cd in children) and bioconcentration of metals. Furthermore interaction between different metals influences their bioavailability.


Develop age-specific exposure factors. These factors should include behavioural aspects, such as mouthing in young children, time of playing in-doors/out-doors, smoking in adolescents and passive smoking (parental smoking), but also the composition of the food-basket; the diets should be analysed for risk factors e.g. (low) iron and zinc content. Developed exposure models are a prerequisite to realistic risk assessment strategies.. This option will use the improved data resulting from the procedures developed in options 1-3 and will identify areas where improved measurement procedures are required. Pilot studies recommended under option 4 will inform research requirements.

How will the objective be achieved? A comprehens ive multinational research programme, over a period of years, to:

– Review the models used to determine exposure currently and their suitability for children, using pilot studies (possibly

linked to Option 4), – Question whether these are suitable for exposure to new sources or routes of exposure – Develop new integrated models – Use the results of the integrated modelling to inform risk modelling and policy development.

Main stakeholders affected by the option and how they are affected: Environment and Health Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial Resource allocations for environmental monitoring would be optimised, particularly in instances

where modifications to existing monitoring programs may increase the relevance and utility of the data generated. In the long-term, the developed models would help to target policy and regulatory initiatives on the exposure vectors that make the most significant contributions to children’s exposure.

health Data of greatest relevance to paediatric exposure would be collected, thereby facilitating future


health assessments and efforts to validate the adequacy of existing regulatory limits. environmental Human exposures to metals may occur though a subset of the environmental media of traditional

concern to environmental risk assessment. Realistic models of human exposure vectors and exposure levels, as much as environmental exposure pathways of metals, will provide tools for effective control monitoring programmes.

other costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial Research programmes health environmental other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Is further analysis needed?: What would be the work programme?: What be the working method? : National and international research organisations within the context of a European research

initiative.


Option 5b

• Research - Effects

Option for action: A programme of work:

– Which, for various media and exposure vectors, develops new effect assessment methodologies for metals, particularly soluble forms (i.e. arsenic, cadmium, nickel, platinum, chromium, palladium, antimonium) metal compounds (organotins,nickel compunds, Cr+3,+6; As+3,+5) and combination of metals depending on the sources and different medium (for example platinum&rhodium&palladium in air; mercury &arsenic in fish)

– Innovative work to increase the sensitivity and specificity of traditional methodologies as an aid to the establishment of dose-response relationships for low-level heavy metal exposures.

– On the effects of chronic exposures. – Determine the increased risk due to genetic susceptibility.

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: Several factors can contribute to under or overestimate effects of heavy metals. Among them: the

variations in susceptibility to many environmental toxins, including metals, is believed to be due to genetic and constitutional factors, like sex and age, being children and pregnant women often the most susceptible categories. We are now aware that genetic polymorphisms that affect primarily xenobiotic metabolism or cellular response to toxic insults can modulate individual sensitivity to toxicants. On the other hand sampling, analytical, and reporting standards are used that were developed for use at the relatively high concentration levels resulting from exposure to well characterised industrial emissions or for commercial product conformance testing. Lot of information available on acute effects whereas for general population, particularly children, the health effects that are most likely to occur from long-term, chronic, exposure to low level of metals then, adverse effects may be evident many years after exposure. In addition the available biomarkers both exposure and effect, are in most cases invasive then and may be judged by so to be excessively traumatic for young children.


What is the problem (qualitatively and quantitatively where possible)?: To estimate the role of genetic variation in the identifiable differences in disease risk due to the

presence of metals in the environment among individuals in the general population and in populations at major risk of exposure. Concerning chronic effects to low level exposures, It is not known whether the available methodologies (or derivatives) for sampling, analysis and data reporting are capable or sensitive enough to allow:

o fair comparison of apparently similar data sets relating to single components. o detecting the effects of metals other than the priority set (Hg, Cd, Pb, Ni, As), metal

combinations, cumulative or synergetic effects5

Why has the problem arisen?: The apparent differential human susceptibility, combined with our incomplete understanding about

mechanisms of toxicity of many metals and its combinations create important public health concerns and challenges in risk assessment

General objective in context of a European Integrated Environment and Health Monitoring and Response System: – Generate synergies and facilitate the sharing of data and methodologies XX Increase the understanding of the environment and health relationship – Improved data availability, accessibility, comparability – Enhanced exchange of information

The research programme will improve knowledge of the effects, on children, of exposure to

the metals.

o Hg,, Cd As, Ni, speciatium. Sn, Sb,Cr,Tl, Pt, Pd, Rh,Se, Ur[Cu Zn,Fe]

– Identify the likely metal, metal combinations which may create a risk, (on the basis of

option 1, 5 N.B. this is the research requirement associated with the gernral requirement specified in Option 3.


– Low level exposure for children in the general population, – Chronic exposure to known and new metals/ combinations/compounds, – Effects of combinations of metals and compounds, – Develop non- invasive biomarkers for Lead and the new metals under

examination.(Pt,Rd,Ni,Sn,Sb,Cr,Tl,Se) – Complete toxicity assessment, for instance concerning neurotoxicity and estrogenic

atctivity at low doses of cadmium. – Identify new effects of metal exposures.

How will the objective be achieved? A comprehensive multinational research programme, over a period of years, to:

Review By means of research programmes to better understand qualitatively and quantitatively the effects to metal exposure in a much more wider view. Main stakeholders affected by the option and how they are affected: The option can be extended and could involve other categories of pollutants (e.g. Endocrine

Disrupters and Dioxins) because individual susceptibility can be responsible of different health outcomes induced also by other toxicants. Since metals have been found to be responsible of childhood respiratory diseases, asthma, allergies (nickel...), neurodevelopmental disorders (lead, mercury..), childhood cancer (arsenic..), individual susceptibility, for example, deserve to be studied in the frame of joined actions with those proposed by other

Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial Since the control of health expenditure has become one of the main axes of health policy,

interventions aimed at reducing the burden of diseases due to the exposure of metals in the environment will decrease the economic impact of material and human resources required for the


diagnosis, treatment, and follow-up of patients with different diseases.

health The study findings may guide researchers in designing and testing specific biomedical/public health interventions by incorporating knowledge of inherent variations in susceptibility to metal effects.

environmental From the general policy perspective, the findings should reinforce the importance of reducing specific metal exposures.

other Findings may have important research and policy implications.

costs, disadvantages (qualitative descrip tion should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial Some times studies may identify a genetic polymorphism that appears to play a role in inducing

health adverse effects, but the extent to which its effects are mediated by environmental factors could remain unclear.

health None environmental Ethical legal and social issues have to be carefully considered.

Genetic studies often present special challenges in protecting human subjects because genetic research frequently pose psychosocial risks that may be difficult to anticipate and convey to prospective participants. The risks can include possible discrimination or stigmatisation and adverse effects on a participant’s self image.

other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Is further analysis needed?: What would be the work programme?: Some feasible experimental approaches are listed below:

⇒ Studies aimed to understand the role of speciation of metals, to identify those more involved in toxic effects, by means of integrated environmental and human


biomonitoring. ⇒ Characterization of key genes involved in the metabolism (including uptake,

biotransformation, excretion..) or in other pathways (DNA repair, cell cycle control, apoptosis...) that are affected by specific metals, in order to identify genes where variant alleles are associated with disease risk.

⇒ Biomonitoring studies that take into account biomarkers of exposure, effect and susceptibility (see Option 4a)

⇒ Identification of susceptible group of individuals in the general population where most disease occurs, in restricted areas, where specific exposures to metals have been determined. (see Option 4b)

⇒ Studies aimed to clarify how combinations of different genotypes and/or other host and environmental factors play a role in the induced effects from metals.

What be the working method? : Research calls at EU and ms level

.


Option 5c

• Research – Identification of new risks

Option for action: A programme of work to develop risk assessment methodologies for metals, metal compounds, and

metal combinations from previously unrecognised sources which are found in the exposure vectors for children.

What is happening just now (describe the current situation qualitatively and quantitatively where possible)?: See action 7a and 7b What is the problem (qualitatively and quantitatively where possible)?: Why has the problem arisen?: General objective in context of a European Integrated Environment and Health Monitoring and Response System:


The research programme will identify novel sources of childrens’ exposure to metals, metal

combinations, and compounds. It will also identify risks from previously unsuspected metals,

combinations and compounds. On the basis of these finding it refine or develop suitable risk

assessment methodologies for use in characterizing the potential ‚new’ risk. The action will be complementary to options 7a (exposure) and 7b (effects) and methodology validation may be undertaken as using pilots studies.

How will the objective be achieved?


A comprehensive multinational research programme, over a period of years, to:

• Search for and characterise ‘new’ sources of childrens’ exposure to the ‘target’ set of metals,

o Insert list • Search for and characterize ‘new’ metals, combinations, and compounds in known childrens’ exposure vectors,

o Insert list • Identify those combinations that might reasonably be expected to pose a health risk. • Develop suitable risk assessment methodologies where appropriate.

Main stakeholders affected by the option and how they are affected: Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial health environmental other costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial health environmental other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Is further analysis needed?: What would be the work programme?: What be the working method? : National and international research organisations within the context of a European research


initiative.

Benefits, advantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions. For example, how will the impacts relate back to the problem identified above?): Financial health environmental other costs, disadvantages (qualitative description should be provided of all impacts, along with either quantification of the impacts or examples and underlying assumptions.) Financial health environmental other Alternative ways of achieving the same objective, and their pros and cons relative to the option chosen. Is further analysis needed?: What would be the work programme?: What be the working method? : National and international research organisations within the context of a European research

initiative.

integrated monitoring of heavy metals - european commission · environment and health monitoring...

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