CHAPTER 1: Overview of Alerting, Assessing and Responding to Chemical Public Health Threats

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).¹  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.² 

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.^3–5  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.⁶ 

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.

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).³⁶  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).⁷  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.⁸  Notification of the WHO is required under IHR for all ″events that may constitute a public health emergency of international concern″ (PHEIC)⁸  (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).

In 2013 the European Parliament and Council adopted the Decision on serious cross-border threats to health [1082/2013/EU].⁹  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].¹⁰  The Decision⁹  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.

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.

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^11–25  and there are, as yet, no specific regulations governing RASCHEM.²⁶  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).

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.²⁷  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.^28,29 

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 countries³⁰  (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.

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).

The Rapid Alert System for Food and Feed (RASFF) is an effective international information exchange platform for food and feed control authorities to share information on measures for responding to serious risks in relation to food or feed.^31,32  This exchange of information helps Member States to act rapidly in a coordinated manner for responding to potential health threats caused by contamination of food and feed products. There are several types of notification reported to RASFF (Box 1.3).

RASFF is an effective tool for sharing information, in 2016 there were 2993 new notifications to RASFF, of which 847 were classified as alerts, 378 as information for follow-up, 598 as information for attention and 1170 as border rejection notifications. The original notifications resulted in 7288 follow-up notifications (representing an average of 2.4 follow-ups per original notification). For alert notifications there were 5.5 times more follow-ups per original notification, implying a serious health risk of a product circulating on the market, which rose by 9%, with 16% more follow-up notifications transmitted in 2016 compared with 2015.²⁹ 

The most reported risks in 2016 to RASFF were the presence the of pesticide residues in fruits and vegetables; aflatoxins in nuts, nut products and seeds; mercury in fish and fish products and Salmonella in fruits and vegetables.³¹ 

EU MSs are members of RASFF, together with the EC and the European Food Safety Authority (EFSA), Iceland, Liechtenstein and Norway. RASFF members each have a designated contact point that is responsible for sending RASFF notifications to the EC. Alert notifications to RASFF are quality assured by the EC, then sent onwards to all MS via contact points and/or border points and third countries if appropriate. Access to the RASFF system is 24/7.

The European Commission have established two independent non-food Scientific Committees to provide scientific advice to inform policy and proposals relating to consumer safety, public health and the environment. The Committees also highlight new or emerging problems which may pose an actual or potential threat. These committees include the Scientific Committee on Consumer Safety (SCCS) and the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). Both Committees review and evaluate relevant scientific data and assess potential risks. Each Committee comprises of independent experts who are committed to work in the public interest. In addition, the EC also rely upon the work of other Union bodies, such as the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA).³² 

The SCHEER³³  provides opinions on questions concerning health, environmental and emerging risks. In particular, SCHEER addresses emerging or newly identified health and environmental risks as well as broad, complex or multidisciplinary issues that require a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other EU risk assessment bodies.

For example, SCHEER may be invited by the EC to provide an opinion on potential risks associated with antimicrobial resistance; new technologies, such as nanotechnologies; medical devices, including those incorporating substances of animal and/or human origin; tissue engineering; blood products; fertility reduction; physical hazards, such as noise and electromagnetic fields; the interaction, synergic effects and cumulative effects of risk factors and methodologies for assessing new risks. It may also be invited to address risks related to public health determinants and non-transmissible diseases. The SCHEER also provide opinions on risks related to pollutants in environmental media and other biological and physical factors (or changing physical conditions) which may have a negative impact on health and the environment, for example in relation to air quality, water, waste and soil, as well as on life cycle environmental assessment. These opinions are prepared on the request from the Commission. For further details see: https://ec.europa.eu/health/scientific_committees/.

Following Decision 1082/2013/EU on serious cross-border threats to health when a coordinated response at European Union level is required, the EC are now able to provide a rapid risk assessment of the potential severity of the threat to public health, including possible public health measures for chemical incidents by accessing support from its Scientific Committees. Further support from additional experts (as necessary) is available to ensure that a timely and sound rapid risk assessment is undertaken. The SCHEER is responsible for coordinating the preparation of the rapid risk assessment to support the EC in their response to a cross border chemical health threats. These include both man-made and naturally occurring events (e.g. chemicals released during an incident or during a volcanic eruption) that may have an impact on public health. However, these rapid risk assessments do not cover the wider effects on the environment (see Chapter 8).

Poison information centres (or poison control centres) are specialised units providing information on poisoning either to members of the public or limited to public health professionals (as in the UK). The main functions of a poisons centre include the provision of toxicological information and advice for the management of poisoning cases, provision of laboratory analytical services, provision of toxicovigilance activities, research and education and training in the prevention and treatment of poisoning. This includes the provision of information and advice concerning the diagnosis, prognosis, treatment and prevention of poisoning, as well as about the toxicity of chemicals and the risks they pose. Access to the service is normally by telephone (especially in an emergency), but there are several other communication channels, including websites, written responses to enquiries and publications. Poisons centres typically have an accessible information service (i.e. telephone) 24 hours a day, seven days a week, throughout the year.

As an example, in the UK, the National Poisons Information Service (NPIS) provides information and advice for National Health Service (NHS) healthcare professionals to support the management of patients with suspected poisoning. This is an essential clinical service because of the substantial numbers of patients presenting each day (over 170 000 people attend UK hospitals each year³⁴ ) and the enormous variety of substances and circumstances that might be involved in poisoning and exposures. Many more are managed in primary care, including by NHS advice services such as NHS 111, NHS 24 and NHS Direct. The NPIS provide information and evidence-based management advice in the UK via its online poisons information database TOXBASE (https://www.toxbase.org/) and its 24 hour telephone advice service, staffed by poisons information specialists and supported by a rota of consultant clinical toxicologists for more complex cases. The availability of this expertise avoids unnecessary hospital referrals and admissions for patients at low risk of harm, while improving the quality of treatment and shortening hospital stay for those with clinical toxicity. The NPIS also incorporates the UK Teratology Information Service (UKTIS), the national source of information and advice about exposures to drugs and chemicals during pregnancy.

Poison centres regularly exchange information on trends in poisoning, especially when there is the possibility of a cross border element. For example, the Czech methanol poisoning outbreak (September 2012 and August 2014) involved 137 reported cases of acute methanol poisoning (see Appendix 1) and neighbouring countries were notified through informal networks. More recently, in January 2018 a poison centre in the USA reported the deliberate ingestion of liquid laundry pod detergent capsules (“Tide pod challenge”) to RAS-CHEM, and poison centres in Italy, Poland and Germany monitored cases.

Poison centres also have a fundamental role in undertaking toxicovigilance (and subsequently prevention). Toxicovigilance (see Chapter 4) is the active observation and evaluation of toxic risks and phenomena in the community, which should result in measures aimed to reduce or remove risks. Poison centre toxicovigilance activities include:

• identifying serious poisoning risks in the local community and the substances, circumstances and population groups involved

• identifying changes in the incidence of poisoning, e.g. different substances of abuse, application of new pesticides,

• and seasonal variations in the incidence of poisoning, such as carbon monoxide poisoning from heating appliances

• monitoring the toxicity of commercial products, such as household, industrial and agricultural chemicals, as well as pharmaceuticals (by any route of administration), for acute, medium-term and chronic effects, with particular regard to new products and formulations (e.g. overuse of analgesics, occupational exposure to solvents)

• monitoring the toxic effects of drug overdosage

• identifying substances that cause significant morbidity and mortality and specific effects on target organs (e.g. high incidence of renal insufficiency, foetal malformations)

• reporting to health authorities and other relevant bodies situations that demand preventive or corrective action and, where appropriate, calling an alert

A recent example highlighting the importance of this toxicovigilance activity is the emerging trend of poisonings in young children associated with liquid laundry detergent capsules (LLDCs). Accidental exposures have been associated with a higher frequency of poisonings in comparison with traditional detergents, predominantly involving children under the age of five, as reported internationally by poison centres from 2005 to 2016. Following the emergence of this trend in poisoning associated with these products, European manufacturers introduced a voluntary programme in 2012 and 2013 followed by EU legislation and regulatory measures for consumer protection in 2014 including warning labels and pictograms to increase public awareness of the risks, addition of aversive (bittering) agent to the soluble film and improving the soluble film integrity (see Chapter 4).

There are a number of different mechanisms to alert competent authorities to unexpected health threats from chemicals along with considerable EU legal requirements to report such incidents. The recently adopted EU Decision 1082/2013/EU for serious cross-border threats to health attempts to combine reporting and alerting systems into one overarching platform. Criteria have also been agreed to ensure that only serious incidents are bought to the attention of the European Commission and other MSs on the EWRS system. Similarly the reporting requirements for the EWRS are based upon those defined by the WHO under IHR, thus avoiding significant duplication of national assessment and effort.

The co-ordinated assessment of events will help MSs in deciding on the most appropriate risk management measures; ensuring that risk communication through media and public messages are consistent; and reporting serious threats to other MSs and sectors in a timely manner.

Fortunately cross-border chemical health threats are relatively rare, but they do have inherent risks associated with them. Chemical events often have a rapid onset with immediate health consequences and can require a rapid medical and public health response. If there are delays in communicating these events to and from NFPs this could have significant health impact. It is important to test the communication mechanisms to ensure that information sent by the NFPs reaches the relevant actors (e.g. Poisons Centres and Public Health Authorities). Similarly there are now requirements to ensure that there is improved intersectoral awareness in EU MSs. Each country will have to report to the EC on how different sectors and health information systems interconnect at a national level. It is important that the linkage between the risk assessors (Poisons Centres, Public Health Authorities) and the risk managers (Health Ministries) is well defined for chemical hazards.

It is clear from the number of systems and legislative instruments for the alerting and reporting of potential chemical health threats and hazards that chemical incidents can arise from many sectors with different lead authorities and have diverse public health, commercial, legal and political consequences. For the systems described in this chapter there is some variation in notification time requirements. The average period is 24–48 hours which, for a chemical incident, is quite a long period and could lead to unnecessary exposures and may even be after an acute incident has been dealt with. Communicating event information in difficult situations (such as in major accidents) can be challenging, therefore it is important that simple and effective links are established between the different EU alerting and notification information exchange platforms, to ensure those that are affected (or could potentially be affected) are aware of such events and can implement effective risk-mitigation and risks-communication strategies.

From a public health perspective a unified approach will ensure that risks to human health are mitigated quickly and communicated in a consistent way to the public. Interconnecting the relevant systems by signposting, electronic notification or cross posting would ensure that the relevant responders are in receipt of the appropriate information. EU action such as the Decision 1082/2013/EU for serious cross-border threats to health is undoubtedly timely legislation that should help facilitate the management and communication of potential cross-border chemical, biological and environmental health threats in Europe.

A number of these systems are discussed throughout this book, particularly chemical safety and legislation (Chapter 2); mass intoxications (Chapter 3); emerging trends (Chapters 4) and novel agents (Chapter 7); spatial mapping (Chapter 5); surveillance (Chapter 6); risk assessment (Chapter 8) unknown aetiology (Chapter 14); incident management and recovery (Chapters 8, 10, 11, 12 and 13).