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Document1 Public Health Rapid Risk Assessment (RRA) for Chemical Events Document developed in support of Decision No: 1082/2013/EU on the Management of serious cross border threats to health. Developed by ECHEMNET project [20121101] co-funded by European Commission and CARIMEC and CARRANET service contracts Framework Service Contract No 2009 61 05 – Lot 2 Service Contract Agreement No 2010 61 22/21 Who is this document for? 1. EXPERT COMMITTEE/NETWORK OF EXPERTS: For the rapid risk assessment of chemical events that satisfy criteria for a cross border response pursuant with Art 9.1 and 10.2 of 1082/2013/EU. 2. RISK MANAGER: Could be used by national public health risk managers/assessors to aid decision making or strategic assessment. 3. CO-ORDINATOR: Could be used by the European Commission to request for further information on a confirmed or suspected cross border health threat. What is this document for? 1. To allow risk assessment and communication of information relating to cross border chemical public health threats (where they are outside the remit of other organisations in an open, transparent, timely and harmonised manner). 2. To aid in risk prioritisation and defensible decision making process for an emerging chemical event. 3. To ensure relevant stakeholders are informed in a timely manner to aid risk mitigation. 4. To help identify where support may be required. Overarching actions list 1. Read through the RRA before completing the template; linked descriptions provide more information of the template fields. 2. Answer the critical questions in the time available 3. If further, more detailed, hazard specific technical information is required to conduct the RRA, request a Chemical Emergency Risk Management Monograph from SANTE C3. 4. Enable document track changes to ensure that multiple updates are recorded within this document. 5. Highlight important fields that are the focus of the assessment in yellow. 6. If Information is unknown at the time of completion clearly state ‘unknown at the time of completion’. If fields are not required in the development of the RRA state ‘Not Applicable’ in the field. 7. YOU MUST enter summary information in the green fields this information should be used to populate the RRA public summary. Other fields are added to support the assessment – you do not necessarily need to fill in every box – use each filed as a guide 8. Do not include person or person identifiable information of those affected or potentially affected in the incident in this document. 9. The output of the RRA is the summary section – make sure you have enough time to merge (using the merge macro function) – top right circular arrows. 1 Document1 Blank Page 2 Document1 Rapid Risk Assessment for Chemical Events 1. 2. 3. 4. 5. 6. 7. 8. Event Control Data .......................................................................................................................... 3 Hazard Data..................................................................................................................................... 4 Exposure Data ................................................................................................................................. 5 Clinical Case Data ............................................................................................................................ 6 Public Health Factors ...................................................................................................................... 6 Cross-sectoral factors...................................................................................................................... 8 Societal factors ................................................................................................................................ 9 Overall Public Health Risk Characterisation .................................................................................... 9 1. Event Control Data Date & time incident Click here to enter a date. Country of event Click here to enter text. Reporting organisation Click here to enter text. Reporting country Click here to enter text. Source of information Choose an item. Other: Click here to enter text. Click here to enter text. Unique RAS-CHEM Identifier Add link to post Creation date and time Click here to enter a date. Last saved update 28/07/2017 20:29:00 Created by Click here to enter text. Last saved by Assessment requested by European Commission ☐ Health Security Committee ☐ World Health Organization ☐ Date requested Click here to enter a date. Time frame for risk assessment Click here to enter text. Why was the RRA requested? Click here to enter text. What are the critical questions to inform the assessment? Click here to enter text. Names of expert risk assessors engaged in the RRA Click here to enter text. Event summary EU Member State ☐ Other organisation: 3 Document1 2. Hazard Data Event Involving ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Chemical Release from industrial process or accident Chemical contamination of water, air, soil, crops Chemical release during transport Chemical contamination of foodstuff Chemical contamination of non-foodstuff consumer item Medicines Recreational or illegal drugs Deliberate release of chemical(s) Other: RAS-CHEM Alert Level ☐ ☐ ☐ ☐ ☐ ☐ 1a Background information only 1b Unusual event or case, where there is a low level of suspicion about release of a toxic chemical 1c Unusual event - information for poison centres 1c Unusual event - Public health concern 2a Unusual features of poisoning - with no known cause 2b Suspected release of chemical(s) with potential for mass intoxication/significant public health impact 2c Suspected mass intoxication 2d Confirmed mass intoxication 3 Unusual public health event of international concern (PHEIC) ☐ ☐ Reason for Reporting ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Public health impact serious Event unusual or unexpected Significant risk for international spread Significant scope for international coordination/cooperation Event relevant for health security activities Significant risk for international trade and travel restriction Civil unrest and disruption May be of interest to poison centres or public health authorities Hazard Identification Chemical(s) Click here to enter text. CAS Number(s) Click here to enter text. EC Number(s) Click here to enter text. Synonyms Click here to enter text. Chemical group Choose an item. Where is the chemical (exposure pathway)? Choose an item. Further detail on Click here to enter text. 4 Document1 vehicle/exposure pathway Quantity of Chemical Click here to enter text. Toxicological properties Click here to enter text. Detection or confirmation method Click here to enter text. Further information on hazard (including limitations) Click here to enter text. Hazard Assessment Click here to enter text. Certainty of hazard assessment 3. Exposure Data Exposure data details Click here to enter text. Levels of exposure Click here to enter text. Duration of exposure(s) Click here to enter text. Circumstances of exposure Route of exposure Location(s) of exposure Location details Evidence from human biological tests Click here to enter text. Evidence from environmental monitoring or dispersion modelling Click here to enter text. Evidence for cross border spread (EU or wider) Click here to enter text. Weather conditions Click here to enter text. Wider significant Click here to enter text. 5 Document1 receptors (nonhuman) Exposure data further details (including limitations) Click here to enter text. Exposure Assessment Click here to enter text. Certainty of exposure assessment 4. Clinical Case Data Clinical summary affected person(s) Click here to enter text. Observed clinical effects Click here to enter text. Source of clinical effect data Choose an item. Poisoning severity Choose an item. Outcome Click here to enter text. Clinical data further details (including limitations) Click here to enter text. Clinical case data assessment Click here to enter text. Other: Click here to enter text. Certainty of clinical case data 5. Public Health Factors Location Click here to enter text. Population density Click here to enter text. Map of population density 6 Document1 Schematics or plans for affected installation Likely duration of incident/release Click here to enter text. Vital statistics of affected population Click here to enter text. Sensitive receptors Click here to enter text. Local health care facilities and provision Click here to enter text. Local decontamination arrangements Click here to enter text. Required antidotes Click here to enter text. Required medical support Click here to enter text. Personal protective equipment Click here to enter text. Shelter in place or evacuation requirement Click here to enter text. Handling of deceased Click here to enter text. Epidemiological study or contact tracing required? Click here to enter text. Biomonitoring required? Click here to enter text. Long term follow-up or psycho-social care required? Click here to enter text. Recovery and environmental decontamination factors Click here to enter text. 7 Document1 Other environmental factors Click here to enter text. Similar past events in country or otherwise? Click here to enter text. Evidence for cross border spread (EU or wider) Click here to enter text. Public health data assessment further details (including limitations) Click here to enter text. Public health data assessment Click here to enter text. Certainty of public health data assessment 6. Cross-sectoral factors Police, security, military or forensic factors Click here to enter text. Transport and migration factors Click here to enter text. Control of sales Click here to enter text. Border control factors Click here to enter text. Impact on water resources Click here to enter text. Impact on food supply chain Click here to enter text. Impact on animals and agriculture Click here to enter text. Rehousing, education and local facilities Click here to enter text. Economic factors Click here to enter text. Cross-sectoral factors further details (including limitations) Click here to enter text. 8 Document1 Cross-sectoral assessment Click here to enter text. Certainty of crosssectoral assessment 7. Societal factors Religious, cultural or social impacts Click here to enter text. Policy or political impact Click here to enter text. Media interest Click here to enter text. Other societal factors further details (including limitations) Click here to enter text. Societal assessment Click here to enter text. Certainty of societal assessment 8. Overall Public Health Risk Characterisation Main risks identified from section 1-7 above Click here to enter text. Estimates of likelihood Choose an item. Estimates of consequences Choose an item. Level of overall risk Choose an item. Level of confidence in risk assessment Choose an item. Key aspects of assessment in estimating risks List headings Are there aspects likely to change significantly Should a follow-up risk assessment be undertaken? If ‘yes’ when should a follow-up risk assessment be undertaken? DISCLAIMER: This document is currently in draft format and will remain so until it has been finalised and agreed. Neither the European Commission, ASHTIII or ECHEMNET group nor any person acting on behalf of the EC, the ASHT or ECHEMNET group is responsible for the use which might be made of this document. The authors of the assessment have carefully checked the fields proposed to form the document to ensure that is complete and generally in accord with the standards accepted at the time of update. However, in view of the possibility of human error or changes in medical sciences, neither the authors nor the leader of the ASHTIII or ECHEMNET projects nor any other party who has been involved in the preparation of this work warrants that the information contained herein is in every 9 Document1 respect accurate or complete, and they disclaim all responsibility for the results obtained from use of the information contained in this work. Users are advised to check the information included in assessment to be certain that the information contained in the document is accurate and will provide a robust and detailed assessment of cross border chemical health threats that are outside of the remit of other organisations. They are also advised to consult regional Poison Control Centre or National Public Health Authority for any additional information, if needed. 10 Document1 Rapid Risk Assessment –Summary Title: Click here to enter text. Date: 28/07/2017 Number of Update Click here to enter text. Key updates in this document Click here to enter text. Key conclusions Click here to enter text. Summary risk assessment (from below) Click here to enter text. Requested by: Date of request Click here to enter text. Click here to enter a date. Why was the RRA requested, including critical questions? Click here to enter text. Rapid health risk assessment working group: Click here to enter text. Event summary Click here to enter text. Hazard assessment Click here to enter text. Exposure assessment Click here to enter text. Clinical case data assessment Click here to enter text. Public health data assessment Click here to enter text. Cross sectoral assessment. Click here to enter text. Societal assessment Click here to enter text. 11 Document1 Risk characterisation Click here to enter text. Conclusions Click here to enter text. DISCLAIMER: This document is currently in draft format and will remain so until it has been finalised and agreed. Neither the European Commission, ASHTIII or ECHEMNET group nor any person acting on behalf of the EC, the ASHT or ECHEMNET group is responsible for the use which might be made of this document. The authors of the assessment have carefully checked the fields proposed to form the document to ensure that is complete and generally in accord with the standards accepted at the time of update. However, in view of the possibility of human error or changes in medical sciences, neither the authors nor the leader of the ASHTIII or ECHEMNET projects nor any other party who has been involved in the preparation of this work warrants that the information contained herein is in every respect accurate or complete, and they disclaim all responsibility for the results obtained from use of the information contained in this work. Users are advised to check the information included in assessment to be certain that the information contained in the document is accurate and will provide a robust and detailed assessment of cross border chemical health threats that are outside of the remit of other organisations. They are also advised to consult regional Poison Control Centre or National Public Health Authority for any additional information, if needed. END PRINT PAGE HERE IF RISK ASSESSMENT IS COMPLETED AND REQUIRES PRINTING ON PAPER OR SAVING AS PDF FOR DISTRIBUTION. 12 Document1 Rapid Risk Assessment Field Descriptions Linked Descriptions These are internal document links that provide additional information to the risk assessor. Event Control Data Much of this information should be available from the RASCHEM entry for the event. If the event is not posted to RASCHEM this should be done immediately. Date & time incident Select date of the incident from the calendar. If known add time of the event using the 24 hour clock (e.g. 23:00) Reporting organisation The organisation which posted the initial report on the incident. Reporting country The country which posted the initial report on the incident Country of event The country or countries affected (or potentially affected) by the incident Source of information Unique RASCHEM Identifier Drop down list to select where event information has emerged from (e.g. media). Free text field ‘Other’ for sources not listed. If there is more than one source of information please add additional sources in the ‘other’ field A free text summary of the event including key aspects (e.g. contamination of children’s toy (Aquabeads) with 1,4-butanediol, several children with severe poisoning in UK) This is the unique event identifier which is generated when the event is posted to RASCHEM. Copy this unique ID into this field. Creation date and time Document control field. Automatically added to the document when the document is first used. Last saved update Document control field. Automatically added to the risk assessment when the document is saved. Created by Document control field. Automatically added to the document when the risk assessment is created. Last saved by Document control field. Automatically added to the document when the risk assessment is saved. Tick box. Select the organisation that have requested a rapid risk assessment Event summary Assessment requested by Date requested Time frame for risk assessment Why was the RRA requested? What are the critical questions? Select the date and enter the time using 24 hour clock (e.g. 23:00) of when the rapid risk assessment was requested. A clear indication of the timeframe requested should be added here; this should be discussed and agreed with DG-SANCO Health Threats Unit and Scientific Committee Member(s) This information should have been provided by the organisation requesting the risk assessment. The information may relate to the potential risk and hazard involved. The nature of the request is important in determining the type of risk assessor (e.g. clinical toxicologist or organic chemist) The formulation of the risk questions is a key step in the RRA. It is likely that the organisation requesting the RRA will have established the risk questions. If this has not been done then the potential questions should be discussed and confirmed with DG-SANCO Health Threats Unit and Scientific Committee 13 Document1 Names of expert risk assessors engaged in the RRA Hazard Data Hazard Identification Chemical(s) CAS Number(s) EC Number(s) Synonyms Chemical group Member(s) involved. For further information refer to pages 9-11 in the WHO Rapid risk Assessment to Acute Chemical Events: http://whqlibdoc.who.int/publications/2009/9789241598149_eng.pdf?ua=1 List the names of the expert risk assessors and Scientific Committee who were engaged in developing the RRA. This is a critical step in the RRA and care should be taken in selecting appropriate expertise and skills. Please refer to the risk assessor database and risk assessor skills framework. An operating procedure for selecting risk assessors for a given threat will be developed within the ECHEMNET project Hazard identification is the identification and description of a chemical or chemicals causing the public health event. The first section consists of check boxes in order to ascertain the nature and scale of the event; this information should also be posted to the relevant RASCHEM entries These fields try to capture essential information about the nature of the hazards. This information should be made available in the RASCHEM entry or if provided in the corresponding Chemical Emergency Risk Management Monograph Common name of chemical or substance Chemical Abstracts Services Registry Number available here: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventorydatabase EC number, also known as EC No., EINECS No., and EC#, available here: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventorydatabase List alternative names for chemicals, where possible including systematic, street and other languages http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventorydatabase http://echa.europa.eu/information-on-chemicals/registered-substances http://www.inchem.org/ Include chemical group if known e.g. Acutely toxic substances, such as carbon monoxide, hydrogen sulphide, hydrogen cyanide, acrylonitrile Irritating/corrosive substances, such as chlorine, ammonia, sulphur dioxide, hydrogen chloride (hydrochloric acid) Pulmonary (lung) toxicants, such as phosgene, oxides of nitrogen Sensitizing substances, such as acrylates, formaldehyde, toluene diisocyanate (TDI) Carcinogenic and mutagenic substances, such as benzene, acrylamide, butadiene Reprotoxic substances Metal fumes/vapours, such as mercury Combustion gases Chemical weapons, such as nerve gases, mustard gases, tear gases, psychochemicals, opiates, fentanyl derivatives Organic solvents, such as methanol, toluene, xylene Nanoparticles and nanomaterials Pharmaceuticals and medicaments (e.g. analgesics, anti-coagulants and 14 Document1 Where is the chemical (exposure pathway)? anti-inflammatories) Industrial/agricultural (fertiliser/pesticide/biocide) Consumer products Toxins from a biological origin (such as venoms, botulism) licit/illicit drugs of abuse Drop down list of vehicle that embodies or contains the toxic substance or chemical Further detail on vehicle/exposure pathway If possible add further free text information on the chemical vehicle (e.g. trade names, product type). Quantity and concentration of chemical Toxicological properties Detection or confirmation method If appropriate enter quantity of chemical involved in metric units o Solids: mass (e.g. 42,000 Kg, 100mg). o Liquids: volumes (e.g. 5 litres or 100mls) molar concentration (e.g. 17M or 1.23x10-2M) o Gases: parts per millions (PPM) o Aerosols or dusts: milligrams per metre cubed (mg/m-3) Provide an indication on the key hazardous properties and inherent toxicological properties using: o The Globally Harmonised System terms and codes: http://echa.europa.eu/web/guest/information-on-chemicals/clinventory-database o Corresponding Chemical Emergency Risk Management Monograph o IPCS INCHEM resources: http://inchem.org/ o Public Health England Chemical Compendia Entries: http://www.hpa.org.uk/Topics/ChemicalsAndPoisons/ChemicalsPois onsAZ/?packedargs=Letter%3DA Include detection methods and investigating laboratory details. This may be environmental sampling or direct/indirect human biological tests . Mention if laboratory or field test confirm a specific cause or are consistent with a particular type of hazard. Include other information in this field which may aid the hazard identification process (e.g. odour, state at room temperature). If there are potential new products or reactions of the release that may cause harm. Indicate where there are uncertainties, where assumptions have been made or if further information is required. Further information on the hazard (including limitations) Hazard assessment Certainty of hazard assessment This process reflects the identification and characterisation of the chemical hazard. This might include reviewing key information and characteristics of the chemical(s) or ranking hazards if more than chemical is involved. Estimating the certainty of the hazard assessment will depend on the nature of the information provided, how quickly the assessment is required and the complexity of the event. This estimate is most likely subjective unless there have been positive results of direct confirmation tests. For more detailed information on qualitative risk assessments: http://www.who.int/foodsafety/publications/micro/MRA17.pdf?ua=1 15 Document1 Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Exposure Assessment Adapted from: http://whqlibdoc.who.int/publications/2009/9789241598149_eng.pdf?ua=1 The Exposure assessment is the evaluation of individuals and populations to hazard presented above. Exposure Data Exposure data details Levels of exposure Duration of exposure(s) Circumstances of exposure Route of exposure Location(s) of exposure Location details Evidence from environmental monitoring or dispersion modelling Number of exposed person(s), age of exposed person(s), sex of exposed person(s), susceptible person(s) (e.g. pregnant, infants etc.). Do not include person identifiable information in the assessment Include information on the level of the exposure for the affected patient/ population. This may rely on indirect environmental monitoring data, information from the incident command or health investigations (e.g. questionnaires, medical consultation) where exposure levels are inferred or estimated. Or by direct measurement of biological samples for the contaminant or metabolite or for biomarkers of effect. The exposure may or may not lead to symptoms of poisoning. Include information of the likely duration of the exposure if this is relevant (e.g. four days for a large chemical fire). Also if there is likely to be a continuous or intermittent exposure. Indicate when the exposure might end. Drop down list of terms describing how the exposure has occurred (e.g. intentional). These controlled terms are from the World Health Organization INTOX definitions list: http://www.who.int/ipcs/poisons/definitions_en.pdf Drop down list of terms describing the way in which the chemical has entered the body (e.g. inhalation). These controlled terms are from the WHO INTOX definitions list: http://www.who.int/ipcs/poisons/definitions_en.pdf Drop down list of terms giving a broad description of the environment where the exposure has occurred (urban, rural). These controlled terms are from the WHO INTOX definitions list: http://www.who.int/ipcs/poisons/definitions_en.pdf . If is more than one location and it benefits the assessment add this information to the additional columns Drop down list of terms describing the specific type of environment where the exposure has occurred (e.g. school). These controlled terms are from the WHO INTOX definitions list: http://www.who.int/ipcs/poisons/definitions_en.pdf . If is more than one location and it benefits the assessment add this information to the additional columns This information constitutes the raw material for assessing and managing the consequences in a specific incident. Translating this information into an estimate of injury also requires knowledge of the safe levels of exposure. Emergency exposure limits— Acute Exposure Guideline Levels (AEGLs), Emergency Response Planning Guideline levels (ERPGs) and Temporary Emergency Exposure Limits (TEELs)—are the key additional ingredients for assessing the consequences of injury. 16 Document1 Acute Exposure Guideline Level (AEGL) values published by the U.S. Environmental Protection Agency (EPA) Emergency Response Planning Guideline (ERPG) values produced by the American Industrial Hygiene Association (AIHA) Temporary Emergency Exposure Limit (TEEL) values developed by SCAPA For any particular chemical, US Department of Energy (DOE) established the following sensible hierarchy of Protective Action Criteria (PAC) values for its facilities and activities: Use AEGLs (including final or interim values) if they are available. If AEGLs are not available, use ERPGs. If neither AEGLs or ERPGs are available, use TEELs. Describe plume modelling such as grounding, plume height, speed of plume, likely progression over 24-48 hours Acute Exposure Guideline Values: http://www.epa.gov/oppt/aegl/pubs/chemlist.htm Emergency Response Planning Guidelines: http://www.aiha.org/getinvolved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Do cuments/2013ERPGValues.pdf Temporary Emergency Exposure Limit http://www.atlintl.com/DOE/teels/teel/search.html Immediately Dangerous to Life and Health values: http://www.cdc.gov/niosh/idlh/intridl4.html Evidence from human biological tests Describe any direct or indirect biological sample test results indicating if they above or below emergency reference values or indicative threshold toxicity levels described authoritative literature sources (e.g. UK Toxbase, Poison information Monographs). This information should be made available in the relevant CERM sheet if this has been made available Chemical Safety Information from Intergovernmental Organisations: http://inchem.org/ European Chemicals Agency Registered Substances Database: http://echa.europa.eu/information-on-chemicals/registered-substances Public Health England Chemical Compendia Entries: http://www.hpa.org.uk/Topics/ChemicalsAndPoisons/ChemicalsPoisonsAZ/?pac kedargs=Letter%3DA Acute Exposure Guideline Values: http://www.epa.gov/oppt/aegl/pubs/chemlist.htm Emergency Response Planning Guidelines: http://www.aiha.org/getinvolved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Do cuments/2013ERPGValues.pdf Temporary Emergency Exposure Limit http://www.atlintl.com/DOE/teels/teel/search.html Immediately Dangerous to Life and Health values: http://www.cdc.gov/niosh/idlh/intridl4.html 17 Document1 Weather conditions Indicate if the immediate or predicted weather conditions will affect the exposure (e.g. wind speed or direction, rain, air pressure, heat, cold) Wider significant receptors (nonhuman) Global Disaster Alert and Coordination System, portal with links to information/data on ongoing events worldwide, incl. Europe (online) o http://www.gdacs.org/ EUMETNET Meteoalarm, weather alerts in EU (online) o http://www.meteoalarm.eu/ Describe if animals or livestock have been exposed and any information from this investigation. If there is veterinary information list this here along with information on organisation involved. Exposure data further details (including limitations) If relevant information is missing from fields above list here. Indicate where assumptions have been made or further information is required. Exposure Assessment This process reflects the identification and characterisation of the exposure pathways and routes. This might include reviewing key information and characteristics of potential or actual levels and duration of exposure and population exposed or potentially exposed. Certainty of exposure assessment For more detailed guidance on Exposure assessment: http://www.inchem.org/documents/ehc/ehc/ehc214.htm#SubSectionNumber:3 .5.2 Estimating the certainty of the exposure assessment will depend on the nature of the information provided, how quickly the assessment is required and the complexity of the event. This estimate is most likely subjective unless there have been meteorological modelling, diagnostic tests or environmental monitoring and sampling. For more detailed information on qualitative risk assessments: http://www.who.int/foodsafety/publications/micro/MRA17.pdf?ua=1 Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Clinical Case Data Assessment Clinical summary affected person(s) Observed clinical effects Source of clinical Adapted from: http://whqlibdoc.who.int/publications/2009/9789241598149_eng.pdf?ua=1 The clinical case data assessment is the evaluation of the clinical features of those intoxicated by the hazard and via the exposure pathway(s) and route(s) described above Include a short summary of the signs and symptoms associated with the exposed/affected individuals; include number and indications of sensitive populations. Do not include person identifiable information in the assessment Include a list of the observed clinical effects. Drop down list of potential sources of clinical data. If the source is not listed use 18 Document1 effect data free text in the right hand box to describe the source of information. Poisoning severity The severity of the poisoning should be marked according to the Poisoning Severity Score (PSS) (Persson et al. J Clin Toxicol 1998; 36: 205-13) As stated by Pearson et al "The severity grading takes into account only the observed clinical symptoms and signs, rather than those that might be anticipated. It does not estimate risks hazards on the basis of information such as amount ingested or serum concentration of the toxic agent" Include an explanation of likely outcome of the exposure such as: full recovery, fatalities likely, health monitoring required, indicate therapies or treatment, potential long term health effects (e.g. cancer) and risks to the unborn. If there are unusual symptoms that may be recognised by healthcare providers include description of this here. Indicate where assumptions have been made or further information is required. Outcome(s) Clinical data further details (including limitations) Clinical data assessment Certainty of clinical data assessment This process reflects the identification and characterisation of the clinical case data of the affected population. This might include reviewing key information and characteristics of the intoxications such as severity, number of people presenting with features of poisoning and the actual or potential health outcomes. Estimating the certainty of the clinical case data will depend on the nature of the information provided, how quickly the assessment is required and the complexity of the event. This estimate is most likely subjective unless there have been clinical review and diagnosis of patients by suitably qualified medical professionals (e.g. clinical toxicologists) For more detailed information on qualitative risk assessments: http://www.who.int/foodsafety/publications/micro/MRA17.pdf?ua=1 Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Public Health Factors Location Adapted from: http://whqlibdoc.who.int/publications/2009/9789241598149_eng.pdf?ua=1 The public health assessment is the broader evaluation of the potential or actual impacts of the event on the populous that may be affected by the hazard via the exposure pathway(s) and route(s) described above. Actual site or position of event and co-ordinates if available or appropriate Local, Regional, National – Latitude & Longitude (either decimal or Degrees, Minutes, Seconds): http://itouchmap.com/latlong.html EC JRC Digital Atlas (online) http://dma.jrc.it/map/ Provides links to Copernicus activations EC Copernicus Emergency Management Service, rapid mapping service (online, maps for events online and for download) o http://emergency.copernicus.eu/ 19 Document1 European Environment Agency, data and maps (online and for download) o http://www.eea.europa.eu/data-and-maps Population density If relevant include population density in persons per square kilometre. Where possible use National Census data. Eurostat Population Information http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Population_st atistics_at_regional_level EC Eurostat Statistical data (online and for download) http://ec.europa.eu/eurostat/data/database Map of population density Schematics or plans for affected installation Likely duration of incident/release Vital statistics of affected population Sensitive receptors Local health care facilities and provision Local decontamination arrangements Insert picture of population density of the affected area(s) Eurostat Population Information http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Population_st atistics_at_regional_level Regional Level Atlas: http://ec.europa.eu/eurostat/statisticalatlas/gis/viewer/?year=2013&chapter=01 For Local Level use National Census Data (for UK): http://www.ons.gov.uk/ons/interactive/census-map-2-1---popdensity/index.html Insert picture of site or plant if the incident is of industrial or environmental nature If the start of the release/incident is known and the likely end of the incident is known (based upon planned mitigation measures) include this here (e.g. Large Industrial Fire in France, fire service estimates burn will last for 2 days) If the vital statistics (e.g. populous by age & sex; birth rate; death rate) of the exposed or potentially exposed population is known add this here. If information about potential sensitive population exposed or potentially exposed is known include here; this could include social deprived populations (malnutrition, education), elderly residential properties, hospitals, schools, nurseries, day care centres; migrant populations etc. This could take the form of a GIS map of sensitive receptors. Include information (name, location, capacity, operational status, contact details) about the local health care provision such as Hospitals, Accident and Emergency Centres, General Medical Centres or Clinics. Where possible include information about specialist centres that may handle large scale incidents or temporary measures as indicated in local crisis management and resilience plans. If information is known from previous sections on the type and number of casualties either known or predicted and the level of care required include this here. Also indicate the likely health-seeking behaviour of the affected population As above if the incident requires personal decontamination measures and information is known about the local arrangements include this here (e.g. mass showering, dry disrobing). If the capacity of the local arrangements and timeline to implement such control measures is known also include this here. 20 Document1 Required antidotes If the incident requires emergency medical countermeasures such as antidotes (e.g. atropine) include this here as well as an indication of the likely number of units required based upon the exposure and clinical data assessments. If the local access to such countermeasures is known in terms of units available and timeline for deployment include this here. Required medical If the incident requires emergency medical support (e.g. dialysis) include this support here as well as an indication of the likely requirement level based upon the exposure and clinical data assessments. If the local access to such countermeasures is known in terms of units available and timeline for deployment include this here. Personal If the incident requires protective equipment for first responders, workers or protective the public (e.g. facemasks, respirators) include this here as well as an indication equipment of the likely requirement level based upon the exposure and clinical data assessments. If the local access to such countermeasures is known in terms of units available and timeline for deployment include this here. Shelter in place Based upon the information within the hazard assessment, exposure or evacuation assessment and local population information presented above describe the requirement sheltering in place or evacuation requirements for the incident (e.g. numbers of houses, people to be evacuated). If local crisis management arrangements are known include this here. handling of If the incident requires the safe management of the fatalities include this here deceased Include considerations such as religious and cultural beliefs, decontamination, temporary mortuary arrangements. Epidemiological Based on the hazard assessment, exposures assessment, and clinical data study or contact assessment; include considerations of potential requirements for tracing required? epidemiological studies, health register or contact tracing of the exposed potential exposed population. Include information about why this should be done and the time frame. http://www.atsdr.cdc.gov/ntsip/ace_toolkit.html Biomonitoring Based on the hazard assessment, exposures assessment, clinical data required? assessment and public health data include considerations of potential requirements for analytical chemistry of the chemical body burden of the exposed potential exposed population. Include information about why this should be done. Long term follow- Consider potential effects on isolated individuals, restricted contact, impacts on up or psycholifestyle (e.g. access to childcare arrangements), psychological considerations, social care social cohesion, acceptability and impact of control measures. required? Recovery and environmental decontamination factors Include consideration of factors related to recovery or remediation for return to new normal (e.g. costs, upheaval, time required) Other environmental factors If there are other environmental factors that should be considered (e.g. tidal factors, negative or other positive effects of control measures) include this here. Similar past events in country or otherwise? If there have been associated or preceding events in the same of neighbouring countries include this information here. Evidence for If there is evidence for cross border spread of the incident that has not 21 Document1 cross border spread (EU or wider) Public health data further details (including limitations) Public health data assessment Certainty of public health data assessment been documented elsewhere include this information here. If relevant information is missing from fields above list here such as unintended consequences of control measures (e.g. removal of food supply by culling of affected animals), privacy, use of untested control measures, equity, duty to provide care, transparency. Indicate where assumptions have been made or further information is required. This process reflects the characterisation of the public health data of the affected or potentially affected population. This might include reviewing key information such as population density; potential control measures and public acceptability and ranking these factors based upon their potential public health impact of the event. Estimating the certainty of the public health data will depend on the nature of the information provided, how quickly the assessment is required and the complexity of the event. This estimate is most likely subjective unless there have been very similar events or comparable events in recent memory. For more detailed information on qualitative risk assessments: http://www.who.int/foodsafety/publications/micro/MRA17.pdf?ua=1 Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Cross-sectoral Factors Police, security, military or forensic factors Transport and migration factors Control of sales Adapted from: http://whqlibdoc.who.int/hq/2012/WHO_HSE_GAR_ARO_2012.1_eng.pdf The cross-sectoral factors section represents a broad and rapid evaluation of the potential or actual impacts on different sectors of the incident in question which may influence the overall assessment of the risks to public health and also suggest where further cross-sectoral collaboration may be necessary. The emphasis of the RRA should be public health, but consideration to the needs of coordinating efforts with other sectors should be considered If the event is of a deliberate nature or large scale then there may be additional factors related to civil protection of military to consider (e.g. chain of custody of samples); include this information here. Also indicate the responsible authority (e.g. Europol) and if this organisation is co-ordinating or collaborating in the crisis response If there are factors related to the transport of people and potential disruption or higher demand, include this here. This might include maritime events, disruption of flights, closure of transport hubs etc. Also indicate the responsible authority and if this organisation is co-ordinating or collaborating in the crisis response If the event results or could result in restriction of sales of products include this here. If possible indicate how trading standard guidelines have been breached; 22 Document1 Border control factors Impact of water resources Impact on food chain supply Impact on animals and agriculture Rehousing, education and local facilities Economic factors Cross-sectoral factors further details (including limitations) Cross sectoral assessment how many products are to be recalled; issues related to product recalling Also indicate the responsible authority and if this organisation is co-ordinating or collaborating in the crisis response If the event could or does impact of points of entry in EU MSs include this here. This might include mass migration of affected individuals; receiving injured nationals or non-nationals for treatment. Also indicate the responsible authority and if this organisation is co-ordinating or collaborating in the crisis response If the event results in or could result in impacts on water resources for drinking, washing, leisure include this information here. If possible indicate how water safety guidelines values have been breached. Also indicate the responsible authority and if this organisation is co-ordinating or collaborating in the crisis response If the event results in or could result in impacts on food supply chain include this information here. If possible indicate how food safety guidelines values have been breached; control measures to be implemented (e.g. removal from sale, further food testing); if the product is processed into other products for downstream resale. Also indicate the responsible authority (e.g. European Food Safety Authority) and if this organisation is co-ordinating or collaborating in the crisis response If the event results in or could result in impacts on animals or agriculture include this information here. This might include restrictions on local farming, testing of livestock, culling of animals. Also indicate the responsible authority (e.g. European Food Safety Authority, DG-Environment) and if this organisation is co-ordinating or collaborating in the crisis response If the event results in or could result in impacts on housing, education or local facilities include this information here. If possible indicate the likely or actual disruption for the local population (e.g. 50 families rehoused for more than 3 months; 3 schools (ages 5-17) closed temporarily. Also indicate the responsible authority (e.g. DG-HOME) and if this organisation is co-ordinating or collaborating in the crisis response Include economic factors not described elsewhere, such as: o associated with direct costs of the incident to the response agencies; o associated with direct costs of the incident to the affected individuals/families/communities; o Indirect costs (ability to work/household income/community income and ; o effects on trade, travel, tourism. If relevant information on the cross-sectoral factors is missing from fields above list here such as NGO involvement; international agreements; disaster relief operations Indicate where assumptions have been made or further information is required. This process reflects the characterisation of the cross sectoral factors of the affected or potentially affected population. This might include reviewing key information such as effects on food or water supply and ranking the factors that 23 Document1 Certainty of cross sectoral assessment may influence the public health impact of the event. Estimating the certainty of the public health data will depend on the nature of the information provided, how quickly the assessment is required and the complexity of the event. This estimate is most likely subjective unless there have been very similar events or comparable events in recent memory. For more detailed information on qualitative risk assessments: http://www.who.int/foodsafety/publications/micro/MRA17.pdf?ua=1 Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Adapted from: http://whqlibdoc.who.int/publications/2009/9789241598149_eng.pdf?ua=1 Societal factors The societal factors section represents a broad evaluation of the potential or actual impacts on society of the incident in question which may influence the overall assessment of the risks to public health. Religious, cultural If there are religious, cultural or social factors that should be considered include or social impacts this here. This might include religious festivals where fasting is observed, cancellation of planned civic ceremonies or events etc. Policy or political If there is a high level or could be a high level of political interest (e.g. from impact political opponents) or there are other factors related to political events (e.g. elections) include this here. Also if there are policies in place that would render the affected population (e.g. political oppression) more vulnerable include this here. This might include regional, national or international dimensions Media interest If the event has caused or could cause a high degree of media interest; including main streams media and social media describe this impact or potential impact here. Other societal If there are other societal factors (e.g. pressure groups, racial tension, civil factors further unrest) that should be considered that are not listed above include this here. details (including Indicate where there are uncertainties, where assumptions have been made or limitations) if further information is required. Societal assessment Certainty of societal assessment This process reflects the characterisation of the societal factors of the affected or potentially affected population. This might include reviewing key information such as political, religious or media aspects and ranking the factors that may influence the public health impact of the event. If possible include a description of the societal impact Estimating the certainty of the public health data will depend on the nature of the information provided, how quickly the assessment is required and the complexity of the event. This estimate is most likely subjective unless there have been very similar events or comparable events in recent memory. For more detailed information on qualitative risk assessments: http://www.who.int/foodsafety/publications/micro/MRA17.pdf?ua=1 24 Document1 Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Risk Characterisation Adapted from: http://whqlibdoc.who.int/publications/2009/9789241598149_eng.pdf?ua=1 Please refer to pages 19-25 of WHO Rapid risk assessment of acute public health events Main risks identified from section 1-5 above In this section bring together the main elements of the sections above that are ranked the most important in evaluating the risks to public health (these sections should be highlighted yellow) Estimates of likelihood In this section estimate the overall certainty of the event by evaluating the certainty of main elements of the assessments described above. Choose one item from the drop down list. Very certain - probability of 95% or more Highly certain - probability of between 70% and 94% Certain - probability of between 30% and 69% Uncertain - probability of between 5% and 29% Very uncertain - probability of less than 5% Estimates of consequences In this section estimate of public health consequences of the event by evaluating the certainty of main elements of the assessments described above. Minimal o Limited impact on the affected population o Little disruption to normal activities and services o Routine responses are adequate and there is no need to implement additional control measures o Few extra costs for authorities and stakeholders Minor o Minor impact for a small population or at-risk group o Limited disruption to normal activities and services o A small number of additional control measures will be needed that require o minimal resources o Some increase in costs for authorities and stakeholders. Moderate o Moderate impact as a large population or at-risk group is affected o Moderate disruption to normal activities and services o Some additional control measures will be needed and some of these require o moderate resources to implement o Moderate increase in costs for authorities and stakeholders Major o Major impact for a small population or at-risk group o Major disruption to normal activities and services 25 Document1 o A large number of additional control measures will be needed and some of these o require significant resources to implement o Significant increase in costs for authorities and stakeholders Severe o Severe impact for a large population or at-risk group o Severe disruption to normal activities and services o A large number of additional control measures will be needed and most of these o require significant resources to implement o Serious increase in costs for authorities and stakeholders 26 Document1 Level of overall risk Using the risk matrices developed for WHO Rapid risk assessment of acute public health events indicates the level of overall risk. Low risk - Managed according to standard response protocols, routine control programmes and regulation Moderate risk - Roles and responsibility for the response must be specified. Specific monitoring or control measures required High risk - Senior management attention needed: there may be a need to establish command and control structures; a range of additional control measures will be required some of which may have significant consequences Very high - risk Immediate response required even if the event is reported out of normal working hours. Immediate senior management attention needed (e.g. the command and control structure should be established within hours); the implementation of control measures with serious consequences is highly likely Level of confidence in risk assessment It is important to document the risk assessment team’s level of confidence in the assessment and the reasons for any limitations. This will depend on the reliability, completeness and quality of the information used, and the underlying assumptions made with respect to the hazard, exposure and context. The more evidence there is to inform the hazard, exposure and clinical, public health, cross-sectoral and societal assessments, the greater confidence the team 27 Document1 Key aspects of assessment in estimating risks Are these aspects likely to change significantly Should a followup risk assessment be undertaken? If ‘yes’ when should a followup risk assessment be undertaken? Key updates in this document Key Conclusions Summary risk assessment (from below) can have in the results. The degree of confidence can be expressed using a descriptive scale that ranges from very low to very high. Indicate the key elements of the assessment that have been used to estimate the overall risk (e.g. hazard identity, airborne concentration calculated from air quality sampling, patients with symptoms, prevailing weather conditions and downstream population) If any aspect of the RRA is likely to change, particularly those that have influenced the risk categorisation process, indicate this here as well as the evidence for this change. This is likely to affect the period that the RRA is valid for and should be clearly indicated Based upon the information in the field above and the nature of the incident indicate if a follow-up RRA or conventional Risk Assessment (RA) (e.g. longer term, quantitative) should be undertaken. Based upon evidence provided in the two fields above indicate when the next RRA or RA should be undertaken. Summary Section Include key points that have changed (or important factors or variables that have remained the same) since the previous assessment. Recommend writing this section at the end e.g. after main sections of the summary have been compiled Include a short summary of the event and the key conclusions as an overview so that risk managers can scan this section and be confident that they are aware of the main important points. Recommend writing this section at the end e.g. after main sections of the summary have been compiled Needs to explain – assumptions, certainties, uncertainties, limitations Should include information from hazard characterisation section and also include main limitations identified throughout the assessment Conclusions 28 Document1 Rapid Risk Assessment User Guide Overarching actions list 1. Read the RRA user guide before completing the RRA; linked descriptions provide more information of the template fields. 2. If further, more detailed, hazard specific technical information is required to conduct the RRA, request a Chemical Emergency Risk Management Monograph from SANTE C3. 3. Enable document track changes to ensure that multiple updates are recorded within this document. 4. Highlight important fields that are the focus of the assessment in yellow. 5. If Information is unknown at the time of completion clearly state ‘unknown at the time of completion’. If fields are not required in the development of the RRA state ‘Not Applicable’ in the field. 6. YOU MUST enter summary information in the green fields this information should be used to populate the RRA public summary Do not include person or person identifiable information of those affected or potentially affected in the incident in this document. 7. COORDINATOR/ASSESSORS: Work through each section of the Risk Assessment; if additional experts are required use the expert database to identify and contact relevant experts. 8. Once the key questions, time frame and working group have been agreed then each member should be assigned a task related to drafting and editing the RRA. 9. Tasks could include drafting a specific section of the RRA (e.g. public health assessment) or reading and editing the main RRA document or reading and editing the summary RRA. 10. ONLY the summary section will be made available to external parties, the topmost sections are purely designed as a working document to ensure that important aspects are considered. IT is likely that some fields will be empty – in which case add N/A 11. If fields are missing but information related to the assessment is important add this to the ‘Further information’ field in the relevant section. Further guidance on conducting RRAs http://www.ecdc.europa.eu/en/publications/Publications/1108_TED_Risk_Assessment_Methodolog y_Guidance.pdf http://whqlibdoc.who.int/hq/2012/WHO_HSE_GAR_ARO_2012.1_eng.pdf 29 Document1 Rapid Risk Assessment Characteristics Has to be delivered in a short time (e.g. 24-36 hours) There will be a limited opportunity to engage with experts outside of the core network of experts and Scientific Committee The RRA may require support for other European Institutions (e.g. ECDC, EFSA, EMCDDA, EMA, ECHA) or International Organisations (e.g. WHO) There will be a limited opportunity to generate new data There will be a limited time to search for data Often have greater uncertainty than classical risk assessment The RRA has to be robust, reproducible and transparent. The RRA has to use plain, understandable language that is easy for decision use to aid decision making The quality of the request needs to be clear and has to have a realistic time frame/ expectations statement A Chemical Emergency Risk Management Monograph may be required to support a RRA. Chemical Emergency Risk Management Sheet Template If the assessment of an event require further technical information on an identified chemical hazard this can be requested from DG-SANCO C3 as a Chemical Emergency Risk Management Monograph Contact: [email protected] 30