This book covers recent developments in the implementation of a European collaboration for assessing cross-border toxicological threats. It discusses the European guidelines for the risk assessment and management of serious international public health dangers. It covers REACH (Registration, Evaluation, Authorisation & Restriction of Chemicals) directives and the work of the ASHT (Alerting System for Chemical Health Threats) project. It will be useful for to public health regulators, toxicologists, poisons centres, industrialists and COSHH (Control of Substances Hazardous to Health) specialists.
About the Author
Professor Raquel Duarte-Davidson is head of the International Research and Development (IRD) Group within the Centre for Radiation, Chemical and Environmental Hazards at Public Health England. Many of their current projects are international collaborations with different public health bodies, universities and poisons centres across Europe. Projects relate to risk assessment, exposure assessment, developing alerting systems using poisons centres across Europe and developing guidance, protocols and training material on the management of chemical incidents. Professor Duarte-Davidson also holds a Visiting Professorship at Cranfield University.
Dr Rob Orford is a Principal Scientist within the IRD group. He is the technical lead for two EU co-funded R&D projects on cross border chemical health threats. The projects cover the European Union level response to serious cross border threats to health from chemicals which includes the development of toxicosurveillance approaches for chemical health threats.
Dr Stacey Wyke is also a Principal Scientist within the IRD group and is the technical lead for recovery and remediation of chemical incidents. She has led EU co-funded R&D projects on cross border chemical health threats and toxicosurveillance, has worked as a Poisons Specialist and is a registered Toxicologist.
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Overview of Alerting, Assessing and Responding to Chemical Public Health Threats
S. WYKE AND R. DUARTE-DAVIDSON
A chemical incident is defined as an unexpected uncontrolled release of a chemical from its containment, often occurring as an acute release. This event becomes a public health incident when two or more members of the public are exposed (or under threat of being exposed). Chemical releases can occur from accidental or deliberate releases and from natural disasters. Chemical incidents may be on a small or large scale and can give rise to a number of primary or secondary chemical casualties and fatalities.
The immediate (acute) response to an incident is usually managed and coordinated by first-line responders (i.e. the police, the fire and rescue service and the ambulance service). Depending on the size and scale a local, regional, national or international response may be required to manage the public health impacts and facilitate a return to normal. Over the past decade, authorities have realised that the spectrum of hazards that could seriously affect societies are many-fold and complicated by the need to deal with different threats. As a result a 'generic' or 'all-hazards' approach became popular and was thought to be a good solution, allowing for better planning and preparing for situations where more than one type of hazard could be involved or where the agent is unknown. The 'all-hazards' approach was also thought to help and enable responsible authorities to deal with more complex public health incidents and emergencies, such as the volcanic ash cloud in 2010 or climate change. Recent events have shown that there are unique chemical risks associated with most non-chemical incidents and therefore it is important to consider these; for example a structure may become damaged by a flood or an earthquake, chemicals may be spilled and could pose a risk to first responders or to people returning to their homes after the event.
Large-scale incidents are rare but can occur, and if they do there is a risk that resources in the affected country may be stretched or overwhelmed. Expert help may be required from neighbouring nations to assist with the response or to provide advice on how to recover from the incident. If there is a cross-border element that needs consideration, such large-scale incidents could potentially affect several countries. The importance of European-wide co-ordination has been recognised, especially in the context of serious cross-border incidents. If there are at least some procedures in common between nations, an international response can be carried out more easily and will therefore be more effective and expedite a return to the new normal. European networks and research programmes have been vital to the development of generic preparedness planning and interoperability to support such activities.
A number of systems have been developed within the European Union (EU) to alert, notify, report and share information on chemical hazards that may present a risk to public health in EU Member States (MSs). These systems cover different sectors, including medicines, emerging and illicit drugs, foodstuffs, consumer products, industrial accidents, deliberate releases, incidents of unknown aetiology, notifications under International Health Regulations (IHR) and events detected by EU Poisons Centres and Public Health Authorities (Table 1.1). These systems have been developed to notify and distribute timely warnings to competent authorities, public organisations, governments, regulatory authorities and public health officials to enable them to take effective action to minimise and manage the risk to public health.
1.2 Mechanisms for Reporting Public Health Risks From Chemicals
1.2.1 International Health Regulations (IHR) – Public Health Emergencies and Events of International Concern
The International Health Regulations (IHR, 2005) were adopted by the 58th World Health Assembly in 2005 and entered into force in 2007. Originally known as the International Sanitary Regulations, these regulations were first ratified in 1951 but were replaced in 1969 with a treaty aimed primarily at infectious disease (with specific focus on cholera, plague and yellow fever). In recognition of the new public health threats arising from greatly increased international travel and trade World Health Organization (WHO) MS agreed to further revisions to the IHR in 2005 to broaden its scope to include all health risks regardless of cause (i.e. bringing in other communicable diseases, chemical, radiological and nuclear hazards, as well as outbreaks of unknown cause). The purpose of the IHR is "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The IHR include both reporting and capacity requirements and are a legally binding agreement that provides a framework for the coordination and management of events that may constitute a public health emergency. Notification of the WHO is required under IHR for all "events that may constitute a public health emergency of international concern" (PHEIC) (Table 1.2). A PHEIC is a rare occurrence, however, countries should notify the WHO about any health event that might or does have an international public health impact. In the case of chemical events the national focal point (NFP) should consider whether the event meets two of the four essential criteria (Table 1.3). To date there have been no PHEIC concerning chemicals (Table 1.2). Countries should carry out their assessment within 48 hours of becoming aware of the event and notify the WHO within 24 hours of their assessment. Where countries are uncertain then they may consult with the WHO in confidence.
Countries should have a designated NFP who is available 24 hours a day, seven days a week (24/7). The WHO designates an IHR contact point at each regional office and at their headquarters, who is also available 24/7. The institution within which the IHR NFP sits is usually concerned with communicable diseases but should communicate with authorities and/or institutions responsible for other public health hazards. There should be a communication channel to the NFP from these other institutions to ensure that the NFP is informed of all events including those outside their remit.
The WHO also has informal contact with IHR NFPs about events that do not constitute a PHEIC. Information is also provided to the public through the organisational website (http://www.WHO.int) and through newsletters (e.g. Disease Outbreak News).
1.2.2 EU Decision 1082/2013/EU for Cross-border Threats to Health
In 2013 the European Parliament and Council adopted the Decision on serious cross-border threats to health [1082/2013/EU]. The Decision directly supports and is in line with the IHR 2005 regulations and applies to public health measures following serious cross-border threats to health from biological, chemical and environmental events as well as events that have an unknown origin. It does not cover radiation as this is covered by the Euratom Treaty [EC, 1314/2013]. The Decision relates to the alerting and notification of serious cross-border health threats and the requirement for national competent authorities to post the event in the Early Warning and Response System (EWRS). It also highlights the process for carrying out public health risk assessments to estimate the potential severity and impact of the threat. EWRS provides notification to the Commission, risk managers in EU MSs and other Regulatory Bodies (e.g. European Food Standards Agency, WHO). For chemical events that fall under Decision 1082, these notifications can be based on information being entered into the Rapid Alert System for Chemicals (RASCHEM). A similar alerting and risk assessment system called the Epidemic Intelligence Information System (EPIS) exists for threats of a biological origin.
1.2.3 Early Warning and Response System (EWRS)
The Early Warning and Response System (EWRS) is a permanent mechanism that brings together the EC and competent authorities for the co-ordinated management of events with a public health impact that potentially affects more than one EU MS. The system was established in 1998 under Decision 2119/98/EC and replaced by Decision 1082/2013/EU in 2013. The EWRS is administered by the European Centre for Disease Control (ECDC), and, although it was originally used to track and monitor the spread of communicable diseases between Member States and to notify other MSs of epidemics and outbreaks, as of February 2014 it was modified to act as a higher level risk management system for biological, chemical and environmental hazards. Following Decision 1082/2013/EU, information transmitted through other EU rapid alerting systems that have been established under EU law should be made available when necessary, to MS via the EWRS.
If the EWRS alerting criteria are met (Box 1.1) then alerting via the EWRS National Contact Point is required. Where an event is flagged from an EU MS to the WHO as meeting the PHEIC criteria (Table 1.2), a simultaneous posting will also be made to EWRS. EWRS is different from the WHO reporting mechanism in that the platform acts as a multilateral information cascade for EU MSs. Notification to the WHO is initially a bilateral notification, which can become multilateral once an assessment has been made by the WHO, extending globally if required. The EWRS has been successfully used in a number of events such as severe acute respiratory syndrome (SARS), avian influenza in humans and other major communicable diseases.
1.2.4 Rapid Alert System for Chemicals (RASCHEM)
RASCHEM is an information portal developed for the notification, alerting and risk assessment of chemical incidents with potential cross-border public health significance. RASCHEM is a specialist tool for expert risk assessors from different MS authorities. Within each MS there should be a main RASCHEM user or RASCHEM Contact Point (RCP) responsible for nominating expert users and, if required, communicating with other stakeholders. Nominated expert users are confirmed by the European Commission.
RASCHEM was developed for EU Poisons Centres and National Public Health Authorities to communicate and exchange detailed hazard and risk assessment information regarding unusual poisoning cases through to confirmed mass intoxications (Table 1.4). RASCHEM has since been developed through successive EU co-funded project grants and there are, as yet, no specific regulations governing RASCHEM. RASCHEM is owned by the EC and hosted by the EC Authentication Service and became operational in 2014 with users from MS Poisons Centres and Public Health Authorities; in addition other sectors may have read-only access to the system (e.g. food standards, network members, trading standards).
1.2.5 Industrial Accident Notification System (IAN) – Cross-order Industrial Accidents
The 1992 Convention on the Transboundary Effects of Industrial Accidents, which has 27 signatories and 41 parties, was designed to protect people and the environment against industrial accidents. The Convention aims to prevent accidents from occurring, or to reduce their frequency and severity and mitigate their effects if required. It promotes active international cooperation between countries, before, during and after an industrial accident.
Parties to the Convention exchange information on major accidents through the Industrial Accident Notification system (IAN). The IAN was designed to help this process by notifying other parties of an industrial accident and, if required, asking other parties for mutual assistance. A good example of an industrial accident with transboundary effects that should have triggered the IAN is the accidental release of 70 kg of hydrogen sulphide from a refinery in Belgium that occurred in 2008. The refinery was situated at the eastern bank of the river Schelde (to the north of Antwerp) 6 km south of the border between Belgium and The Netherlands. The plume affected the health of the public up to 50 km away from the site, and following the release there was significant public anxiety as there was poor risk communication. The authorities in The Netherlands were not informed of the release however, due to the nature and scale of the incident, proximity to neighbouring MS and public health impact this event should have been notified.
1.2.6 Illicit Drugs and Emerging Psychoactive Drugs (Réseau Européen d'Information sur les Drogues et les Toxicomanies; REITOX)
The European Information Network on Drugs and Drug Addiction of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is called the REITOX Network and consists of 44 European countries (see Chapter 7). The network acts as a practical instrument for the collection and exchange of data and information on drug use, particularly psychoactive substances. EMCDDA coordinates a network of NFPs with representation from all EU MS, Norway, the EC and candidate countries. EMCDDA also provides analysis, statistics and advice on emerging and existing drugs in Europe reported by the REITOX network. EMCDDA operates an Early Warning System (EWS) to collate and disseminate timely information.
In particular, the EWS operates when a new psychoactive substance is detected and detailed information on the manufacture, traffic and use and information on possible medical use is sent by European countries to the European Police Office (Europol) via the Europol National Units (ENU) and via the REITOX NFPs to the EMCDDA. Countries are expected to report on any data available in their countries and new information that becomes available.
1.2.7 The Rapid Alert System for Non-food Dangerous Products (RAPEX)
RAPEX is the EU rapid alert system for dangerous consumer products, with the exception of food, pharmaceutical and medical devices, and is a rapid information exchange platform for MS and the European Commission to report on measures for the prevention or restriction of marketing or using products that may pose a serious risk to the health and safety of consumers. RAPEX covers several injury hazards, including electrical and choking hazards and chemical risks. Any measures taken to reduce exposures to products that have these risks should be reported to RAPEX.
The mechanism for reporting consumer products to RAPEX is via National Contact Points, who inform the EC (Directorate General for Health and Food Safety, DG-SANCO) about the product (including information on the risks to consumers; for example, electrical or choking hazard) and the measures taken by the authority to prevent risks and accidents. National Contact Points are normally government organisations dealing with trade and consumer issues (not usually public health bodies). Reporting applies to both obligatory and voluntary measures, although the timing of the notification may vary. Immediate notification to RAPEX is required for obligatory measures whilst a longer notification time period is granted when voluntary measures are adopted. The EC then disseminates this information to the NFPs of all other EU countries. Unlike other platforms, with the exception of RASFF (Section 1.2.8) the EC publishes weekly overviews of dangerous products and the measures taken to eliminate the risks on the internet.
Where a newly notified dangerous product is identified on the market (Box 1.2), MS authorities need to take measures to eliminate the risk, either by requiring that the product be withdrawn from the market, recalling it from consumers or by issuing warnings. Within the UK the National Contact Point is within Government Department for Business, Innovation and Skills (BIS).(Continues…)
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Table of Contents
Overview of Alerting, Assessing and Responding to Chemical Public Health Threats; Chemical Regulation at the European Level: Safeguarding Consumer Health and Protecting the Environment; Medical Management of Mass Intoxications; Hazardous Exposures to Liquid Laundry Detergents Capsules in Young Children; Novel Applications of Spatial Mapping to Chemicals or Biological Outbreaks; Surveillance of Chemical Health Threats; Responding to New Psychoactive Substances in the Europen Union: Early Warning, Risk Assessment and Control Measures; Rapid Public Health Risk Assessments for Emerging Chemical Health Threats; Review of Risk Management Measures to Mitigate Against Exposures to Household Chemical Consumer Products; Understanding and Managing Behavioural and Psychological Responses to Chemical Incidents; Strategic, Technical and Scientific Advice in an Environmental Emergency; Public Health Preparation and Response to Chemical Incident Emergencies; Chemical Incident Management: An Overview of Preparedness, Response and Recovery; Investigating Outbreaks of Unknown Aetiology; Case Study: Methanol Mass Poisoning Outbreak in the Czech Republic: Diagnosis, Treatment and Outcome; Case Study: Fentanils: A Serious Threat to Public Health in Europe; Case Study: Enschede Fireworks Disaster: Lessons Learned; Case Study 4: The ANDE Fire, Paraguay, 2015