National Food Safety Emergency Response Plan (FoSERP)

REPUBLIC OF GHANA MINISTRY OF HEALTH Food Safety Emergency Response Plan (FoSERP) Version 1.0 April 2021 REPUBLIC OF GHANA MINISTRY OF HEALTH June 2022 NATIONAL FOOD SAFETY EMERGENCY RESPONSE PLAN (FOSERP) National Food Safety Emergency Response Plan (FoSERP) TABLE OF CONTENTS LIST OF FIGURES LIST OF TABLES ACKNOWLEDGEMENTS FOREWARD RECORD OF CHANGES DISTRIBUTION LIST DEFINITIONS RELATED DOCUMENTS LIST OF ACRONYMS AND ABBREVIATIONS 1. CHAPTER ONE - INTRODUCTION 1.1 Background 1.2 Purpose 1.3 Scope and Applicability 1.4 Planning Assumptions 1.5 Activation of FoSERP 1.6 Key Emergency Response Authorities 1.6.1 Ghana Health Service (GHS) 1.6.2 Food and Drugs Authority 1.6.3 GRA - Customs Division 1.6.4 Metropolitan/Municipal/District Assemblies (MMDAs) 1.6.5 Plant Protections Regulatory Services Directorate (PPRSD) 1.6.6 Veterinary Service Directorate (VSD) 1.6.7 Ministry of Fisheries and Aquaculture Development 1.6.8 Ghana Standards Authority - GSA 1.6.9 Environmental Protection Agency 1.6.10 Ghana Atomic Energy Commission 2. CHAPTER TWO - EMERGENCY OPERATIONS PHASES 2.1 Prevention, Protection, And Mitigation 2.2 Surveillance, Detection, And Alert 2.3 Response 2.3.1 Receive Information and Maintain Situational Awareness 2.3.2 Activation and Deployment of Resources and Capabilities 2.3.3 Coordination of Response Actions 2.3.4 Deactivation/Demobilization 2.4 Recovery 2.4.1 Evaluation of Response 3. CHAPTER THREE - ORGANIZATION AND THEIR RESPONSIBILITIES 3.1 Ministry of Health 3.1.1 Ghana Health Service 3.1.2 Food and Drugs Authority 3.2 Ghana Revenue Authority - Customs Division 3.3 Ministry of Interior - Police (BNI) 3.4. National Security Secretariat 3.5. Ghana Armed Forces iv v vi vii viii ix x xiii xiv 1 1 1 3 4 5 5 5 5 6 6 6 6 6 7 7 7 8 8 8 10 10 13 14 17 17 18 19 19 19 19 20 20 21 21 Food and Drugs Authority, Ghana ii National Food Safety Emergency Response Plan (FoSERP) National Food Safety Emergency Response Plan (FoSERP) Food and Drugs Authority, Ghanaiii 3.6. Ministry Of Food and Agriculture 3.6.1. The Veterinary Services Directorate (VSD) 3.6.2. Plant Protection and Regulatory Services Directorate (PPRSD) 3.7. Ghana Standards Authority 3.8. Ghana Field Epidemiology & Laboratory Training Programme 3.9. Food Business Operators 4. CHAPTER FOUR - DIRECTION, CONTROL, AND COORDINATION 4.1. FoSERP/MC 4.2. FoSERP/OC 4.3. Field Incident Command 4.3.1. Command Staff 4.3.2. Incident Commander 4.4. Multi-Agency Coordination 4.4.1. National Level 4.4.2. Regional And District 4.4.3. Institutional Collaboration 4.4.4. Institutional Planning and Co-Ordination 4.5. Multiagency Coordination for Foodborne Illness Outbreaks 4.6. Malicious Tampering/Intentional Contamination of Food 4.7. Food Alerts and Recalls 5. CHAPTER FIVE - COMMUNICATIONS AND INFORMATION MANAGEMENT 5.1. Inter-Agency Coordination 5.1.1 Food Safety Emergency Alerts 5.1.2 Situation Reporting 5.2. Communicating Among MDAs 5.3. Communicating Among Regions and Districts 5.4. Communicating With Foreign Partners 5.4.1. INFOSAN 5.4.2. IHR 5.4.3. Reporting Mechanisms and Requirements 5.5. Public Announcement 5.6. Parliament 6. CHAPTER SIX - COMMUNICATIONS AND INFORMATION MANAGEMENT 6.1. Monitoring and Evaluation 6.2. Review of the FoSERP APPENDICES APPENDIX 1: DECISION INSTRUMENT FOR THE ASSESSMENT OF FOOD SAFETY INCIDENTS THAT MAY CONSTITUTE FOOD SAFETY EMERGENCY APPENDIX 2: FLOWCHART OF HANDLING PROCEDURES FOR FOODBORNE DISEASE OUTBREAKS APPENDIX 3: OVERVIEW OF INFOSAN ROLES AND RESPONSIBILITIES APPENDIX 4: EXAMPLE OF ALERT NOTIFICATION APPENDIX 5: NATIONAL GUIDELINES FOR THE RECALL OF FOOD APPENDIX 6: IHR DECISION INSTRUMENT APPENDIX 7: INSTITUTIONS CONSTITUTING THE FoSERP/MC AND THEIR DETAIL 21 21 23 24 24 24 25 25 25 26 27 27 27 27 28 28 29 30 30 30 32 32 32 32 33 33 33 33 34 34 37 38 39 39 39 39 39 40 41 42 43 55 56 Food and Drugs Authority, Ghana vi National Food Safety Emergency Response Plan (FoSERP) LIST OF FIGURES Figure 1: Scalability of responses to food safety events Figure 2: Relationship between NADMO / EOC, PH / EOC and FoSERP / OC Figure 3: Elements of the Food Safety Emergency Response Figure 4: National Food Safety Emergency Response Decision Tree Figure 5: FDA Field Incident Management Team Figure 6: The Food Chain and the Lead Institution during Food Safety Emergency Response Figure 7:Decision trees for determining whether to report via INFOSAN and/or IHR Figure 8: Institution Representation of FoSERP/MC and Their Communication Lines Figure 9: Flowchart of Information Flow/ Reporting Mechanism 1 2 9 11 12 26 29 35 37 38 LIST OF TABLES Table 1: Surveillance and Detection Systems Utilized by FDA Table 2: Events and the lead Institution responsible 10 28 Food and Drugs Authority, Ghanav National Food Safety Emergency Response Plan (FoSERP) ACKNOWLEDGEMENT The National Food Safety Emergency Response Plan (FoSERP) was made possible through the contributions and support of several institutions and individuals. The Ministry acknowledges with gratitude the contribution of the Drafting Team who helped to put this document together including: Dr. David Opare, Chairman (Disease Surveillance Department of the Ghana Health Service); Mrs Jocelyn Egyakwa-Amusah, Mr. Benjamin Osei Tutu, Ms Rita Asante, Ms. Cynthia Hushie (Food and Drugs Authority under the Ministry of Health); Dr. Paul Osei Fosu (Ghana Standards Authority under Ministry of Trade and Industry); Dr. William K. Adu (Veterinary Services Directorate under the Ministry of Food and Agriculture); Mr. Emmanuel Gyan Frimpong (Customs Division, Ghana Revenue Authority); Dr. Eric Kwaku Appiah ( Public Health Department,37 Military Hospital); Mrs. Akosua Kwakye (World Health Organisation Ghana office). Special thanks also go to all those who reviewed and made comments during the drafting of the FoSERP as well as those who participated in the review workshop to validate the document. Sincere thanks are expressed to our development partner, the World Health Organisation (WHO), whose technical and financial support has immensely contributed to the development of this document. Food and Drugs Authority, Ghana vi National Food Safety Emergency Response Plan (FoSERP) FOREWARD Food safety emergencies are increasingly becoming a challenge within countries as well as globally both by virtue of its public health impact and economic implications. As such, limiting the public health impact of Food Safety events means Ghana needs a strong National Food Safety System which has the ability to detect, assess and manage the Food Safety incidence. To this end, the Food and Drugs Authority (FDA) with technical support from World Health Organisation (WHO) organized a stakeholders’ workshop to strengthen collaboration among all relevant institutions along the food chain for a National Food Safety Alert System. The stakeholders agreed that developing a National Food Safety Emergency Response Plan was critical to the setting up and operationalization of the National Food Safety Alert and Response System. The Ministry of Health (MoH) in collaboration with relevant Ministries, Departments, Agencies (MDAs) and other partners have prepared this Food Safety Emergency Response Plan (FoSERP) for Ghana with the ultimate aim of providing a coordinated and consistent inter-agency approach to prepare for, respond to, and recover from food safety emergencies. This Plan is situated within the context of the National Public Health Emergency Response Plan (NPHERP) and will be activated when emergencies occur along the food chain. The Plan has been produced through a consultative process which included a stakeholder policy formulation and validation workshops. The adoption and implementation of this National Food Safety Emergency Response Plan is expected to enhance Ghana’s ability to detect, assess and manage food safety emergencies and thus reduce the public health impact of these emergencies. The National Food Safety Emergency Response Plan will also provide a basis for the establishment of National, Regional and District Rapid Response Teams to manage and control these emergencies along the food chain. Through the adoption and promulgation of this plan, the Government of Ghana reaffirms its commitment to fulfilling the constitutional obligation of protecting the lives and health of its populace. Hon. Kwaku Agyemang-Manu (MP) MINISTER OF HEALTH Food and Drugs Authority, Ghanavii National Food Safety Emergency Response Plan (FoSERP) Food and Drugs Authority, Ghana viii RECORD OF CHANGES NOTE: See individual annexes for additional record of changes. CHANGE PAGE SECTION CHANGE DESCRIPTION CHANGEMADE BY DATE National Food Safety Emergency Response Plan (FoSERP) DISTRIBUTION LIST OFFICE OF THE PRESIDENT Office of the Chief of Staff Office of National Security Secretariat MINISTRY OF HEALTH (MoH) Chief Director, MoH Director General, GHS Chief Executive, FDA CEO, Teaching Hospitals MINISTRY OF DEFENCE Chief Director Office of the Chief of Staff General, Headquarters Director General, GAF Medical Service MINISTRY OF FOOD AND AGRICULTURE (MoFA) Chief Director, MoFA Chief Veterinary Officer, VSD Director, PPRSD MINISTRY OF TRADE AND INDUSTRY (MoTI) Chief Director, MoTI Director General, Ghana Standards Authority MINISTRY OF INTERIOR Chief Director IGP, Ghana Police Service Director General, NADMO MINISTRY OF FINANCE Chief Director Commissioner General, GRA Commissioner, Customs Division Assistant Commissioner, Lab MINISTRY OF LOCAL GOVERNMENT Chief Director Directorate of Environmental Sanitation MINISTRY OF ENVIRONMENT, SCIENCE, TECHNOLOGY AND INNOVATION (MESTI) Chief Director Environmental Protection Agency (EPA) MINISTRY OF SANITATION AND WATER RESOURCE Community Water and Sanitation Agency Ghana Water Company Limited MINISTRY OF FISHERIES AND AQUACULTURE DEVELOPMENT Chief Director (MoFAD) Director, Fisheries Commission MINISTRY OF INFORMATION Chief Director Director, Information Services Directorate ACADEMIA AND RESEARCH INSTITUTIONS Council for Scientific and Industrial Research (CSIR) Universities Food and Drugs Authority, Ghanaix National Food Safety Emergency Response Plan (FoSERP) Food and Drugs Authority, Ghana x National Food Safety Emergency Response Plan (FoSERP) DEFINITIONS Biological hazards: Biological agents including microorganisms that have the capacity to cause harmful effects in humans. These include bacteria, viruses, and parasites. Case-definition: A set of criteria for determining whether a person affected by the illness under investigation should be classified as belonging to the outbreak. As such, it is an epidemiological tool for counting cases. It includes clinical and laboratory criteria, a defined period of time, and, as appropriate, limitation/restriction to a place (for example a particular event or restaurant). In some cases, criteria could include a limitation based on personal characteristics (for example age). Cluster: In epidemiological terms, it describes a group of cases linked by time or place, but with no identified common food or other source. In microbiological terms, isolates (e.g., bacteria or virus) having the same specific molecular profile or closely related profiles identified by laboratory analyses of specimens from cases. Contaminant: Contaminant means any substance not intentionally added to food, which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matter (Codex Alimentarius Commission: Procedural Manual). Custom Controlled Area means a place in the country, designated by the Commissioner –General, where the Authority has control over goods, persons and conveyances. Customs Business means an activity that has to do with the importation and exportation of goods. Descriptive Epidemiology: The aspect of epidemiology concerned with organizing and summarizing health- related data according to the occurrence of disease, in terms of demographics, geographical comparisons and descriptions of temporal trends. Emergency: An unforeseen occurrence or a combination of circumstances along the food chain that poses a significant risk to public health and may include, but is not limited to, the safety of food consumption. Export means the act of taking out or causing to be taken out any goods from the country. Food includes water, a food product, a live animal or a live plant, and a) a substance or a thing of a kind used, capable of being used or represented as being for use, for human or animal consumption whether it is live, raw, prepared or partly prepared b) a substance or a thing of a kind used, capable of being used or Food and Drugs Authority, Ghanaxi National Food Safety Emergency Response Plan (FoSERP) represented as being for use, as an ingredient or additive in a substance or a thing referred to in paragraph (a), (c) a substance used in preparing a substance or a thing referred to in paragraph (a), (d)chewing gum or an ingredient or additive in chewing gum or a substance used in preparing chewing gum, and (e) a substance or a thing declared by the Minister to be a food under section 146 (3); Food Business Operator: The natural or legal person(s) responsible for ensuring that the requirements of food law are met within the food business under their control. Food Business: any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food. Food Safety Alert: Alarm that warns risk managers about an impending, unusual, or potentially adverse food safety threat or event at any stage of the food chain, from farm to consumer (FAO). Food Safety Emergency: a situation, whether accidental or intentional, that is identified by a competent authority as constituting a serious and as yet uncontrolled foodborne risk to public health that requires urgent action (FAO/WHO framework for developing national food safety emergency response plans) Foodborne Outbreak: The observed number of cases of a particular illness that may be foodborne exceeds the expected number, OR the occurrence of two or more cases of a similar foodborne illness resulting from the ingestion of a common food and epidemiologic analysis implicates the food as the source of the illness. Goods include an article, currency, merchandise, livestock and produce of the soil. Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect (Codex Alimentarius Commission: Procedural Manual). Import means to bring or cause goods to be brought into the country. Incident: An occurrence or event, natural or man-made along the food chain, that may or may not require response. Information includes data, text, images sounds, codes, computer, programs, software and database. Investigating Agency: The legally mandated MDA which has identified a hazard or is taking the lead in investigating an incident. Lot/Batch: A definite quantity of ingredients or a food that is intended to have uniform character and quality, within specified limits, is produced under the same conditions, and is assigned a unique reference identification number by the food business operator. National Food Safety Emergency Response Plan (FoSERP) Food and Drugs Authority, Ghana xii Manufacturer means to make, produce, or cause to be made or produced, goods. Monitoring: The performance of routine analysis aimed at detecting contamination of food and feed from which prevalence data may be ascertained. Response: A set of activities carried out to address an emergency Risk Analysis: A process consisting of three components: risk assessment, risk management and risk communication (Codex Alimentarius Commission: Procedural Manual). Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization (Codex Alimentarius Commission: Procedural Manual). Risk Characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment (Codex Alimentarius Commission: Procedural Manual). Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions (Codex Alimentarius Commission: Procedural Manual). Risk Estimate: The quantitative estimation of risk resulting from risk characterization (Codex Alimentarius Commission: Procedural Manual). Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair-trade practices, and, if needed, selecting appropriate prevention and control options (Codex Alimentarius Commission: Procedural Manual). Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food (Codex Alimentarius Commission: Procedural Manual). Surveillance: A systematic and ongoing collection, analysis and interpretation of data from samples from humans, animals or food for early detection with the purpose of applying appropriate control measures to prevent foodborne illness. Traceability/Product Tracing: The ability to follow the movement of a food through specified stage(s) of production, processing and distribution. Where “Tracing back” refers to following the path towards its origin/source and “Tracing forward” refers to following the path towards its final distribution/point of consumption. Food and Drugs Authority, Ghanaxiii National Food Safety Emergency Response Plan (FoSERP) Manual for Foodborne Disease Surveillance in Ghana (FDA/FSMD/GL FBD/2014/01) Public Health Act 2012, Act 851 Integrated Disease Surveillance and Response, Ghana (3rd Edition) Guidelines for Handling Foodborne disease outbreaks-FDA/FSMD/G L-FBD/2012/01 National Preparedness and Response Plan for Public Health Emergencies a. b. c. d. e. RELATED DOCUMENTS The following lists of legislation and guidance documents are relevant to the FoSERP: Food and Drugs Authority, Ghana xiv National Food Safety Emergency Response Plan (FoSERP) LIST OF ACRONYMS AND ABBREVIATIONS CBRN DCD DDHS DSD ECP EOC FASDEP FDA FoSERP FoSERP/MC FoSERP/OC FP GAFMS GHS GIS GPS GRA GSA IAP ICP ICS IDSR IHR IHR NFP INFOSAN INFOSAN ECP INFOSAN FP ISO MDA MMDAs MoFA MoFAD NADMO NPHERP NRCD OIE PHEOC POC PPRSD RASFF RRT UNC VSD WHO Chemical, biological, radiological, or nuclear Disease Control Department District Director of Health Services Disease Surveillance Department Emergency Contact Point Emergency Operation Center Food and Agriculture Sector Development Policy Food and Drugs Authority Food Safety Emergency Response Plan Food Safety Emergency Response Plan Management Committee Food Safety Emergency Response Plan Operation Center Focal Point Ghana Armed Forces Medical Services (GAFMS) Ghana Health Services, Geographical Information System Ghana Police Service Ghana Revenue Authority Ghana Standards Authority Incident Action Plan Institution Contact Person Incident Command System Integrated Disease Surveillance and Response International Health Regulations International Health Regulations National Focal Point International Food Safety Authority Network International Food Safety Authority Network Emergency Contact Point International Food Safety Authority Network Focal person International Organisation for Standardisation Ministries, Departments and Agencies Metropolitan, Municipal and District Assemblies Ministry of Food and Agriculture Ministry of Fisheries and Aquaculture Development National Disaster Management Organization National Public Health Emergency Response Plan National Redemption Council Decree World Organisation for Animal Health Public Health Emergency Operation Centre Point of Contact Plant Protection and Regulatory Services Directorate Rapid Alert System for Food and Feed Rapid Response Team Unified National Command Veterinary Services Directorate World Health Organisation Food and Drugs Authority, Ghana1 National Food Safety Emergency Response Plan (FoSERP) 1. CHAPTER ONE - INTRODUCTION 1.1 BACKGROUND Food safety continues to be a major concern worldwide. WHO Estimates that 600 million – almost 1 in 10 people – fall ill after eating contaminated food each year, resulting in 420 000 deaths and the loss of 33 million healthy life years (DALYs). Foodborne illness do not only affect public health but also have enormous economic impact. According to the 2018 World Bank report on the economic burden of foodborne diseases, the total productivity loss associated with foodborne disease in low- and middle-income countries costs up to US$ 95.2 billion per year, and the annual cost of treating foodborne illnesses is estimated at US$ 15 billion. The African region is reported to be the region with the highest burden of foodborne diseases and the highest death rate with an estimated 91 million annual foodborne illnesses and 137,000 deaths. In the recent past, there has been an increasing trend of foodborne outbreaks and the number of people affected in Ghana. From 2016 to 2018, there has been a total of 29 reported foodborne outbreaks in Ghana with a total of 852 persons affected with 19 deaths. Out of the 29 outbreaks, 2018 had the highest number of 14 outbreaks and highest number of deaths of 11 persons recorded. In the same 2018, the listeria outbreak in South Africa also had a great impact on Ghana’s food supply system as Ghana is a major importer of Food products from South Africa. Ready-to-eat (RTE) processed meat products was implicated in the Listeria outbreak and therefore had to be recalled. The INFOSAN Emergency Contact Point in South Africa had to notify Ghana to initial response, as Ghana was a known export destination of the implicated food. All these indicated the increased importance of strengthening Ghana’s structures and mechanisms for preparedness and response to foodborne disease outbreaks and enhancing communication with stakeholders along the food chain within and in other countries through the INFOSAN network. 1.2 PURPOSE The purpose of this FoSERP is to provide for a coordinated and consistent inter-agency approach to prepare for, prevent, protect against, mitigate, respond to, and recover from emergencies. To accomplish this, the FoSERP: Serves as the single, overarching national operational plan to address the full spectrum of natural and technological hazards and bioterrorist threats along the food chain into which all supporting agency emergency plans, procedural documents, and other guidance integrate. Defines the emergency operating structure and assigns essential tasks to all organization/agencies involved in prevention, protection, mitigation, response, and recovery efforts. a. b. Food and Drugs Authority, Ghana 2 National Food Safety Emergency Response Plan (FoSERP) Provides mechanisms for vertical and horizontal command, control, coordination, and communications. Categorises food incidents for management Provides instruction for communicating food incident details to, and between food businesses as well as government agencies. Details the arrangements for categorising, issuing, communicating and activating District, Regional and National Food Alerts. Details the arrangements for investigating food complaints involving food produce locally, food imports and exports. c. d. e. f. g. For purposes of this plan and its supporting annexes: An incident is defined as: An occurrence or event, natural or man-made along the food chain, that requires response (see appendix 1). At the incident level, FDA and/or its collaborating agencies is aware of the circumstances, is monitoring and assessing the situation, and is determining whether it has regulatory authority over the incident. FoSERP/OC shall initiate response operations as described in this plan after assessing incident using appendix 1. Any incident may evolve into an emergency. An emergency is defined as: An unforeseen occurrence or a combination of circumstances along the food chain that poses a significant risk to public health and may include, but is not limited to, the safety of food consumption. Each emergency is unpredictable and dynamic, and any incident has the potential to escalate into an emergency. Scaling down response Scaling up response Incident Emergency Crisis Business as usual Figure 1: Scalability of responses to food safety events Food and Drugs Authority, Ghana3 National Food Safety Emergency Response Plan (FoSERP) The aim of this plan is to set out the arrangements for responsibility of managing food incidents at local and national level involving food hazards as identified by food businesses, official agencies or international agencies (notified through the INFOSAN, IHR, OIE, RASFF, WTO-SPS). The objective of this is to have a co-ordinated approach to ensure that food products identified as being a risk to consumers are controlled or removed from the food chain. Emergencies whether natural or manmade, accidental or intentional, have the potential to cause adverse health and safety effects for large segments of the human and animal populations. In order to mitigate the consequences of such incidents, FDA and its collaborating agencies shall possess the resources and capabilities necessary to prevent, prepare for, protect against, and rapidly and effectively respond to and recover from all hazards. A planned and coordinated approach to emergency operations by these agencies’ organizational components in support of government, with assistance when appropriate from foreign counterparts and international partners, can save lives and ensure that critical public health and medical needs are met. Complaints, adverse events, recalls, or unintentional contamination of food products that present a threat of serious adverse health consequences or death to humans. Foodborne illness outbreaks and pandemics. Accidents, such as hazardous materials releases or spills; air, land, or water contamination; and food safety risk due to utility outages. Terrorist or criminal acts, including the threat or intentional use of chemical, biological, radiological, nuclear, substances in food against human. a. b. c. d. The FoSERP shall establish intra- and interagency mechanisms for FDA involvement in domestic and international incident management operations. These mechanisms include coordinating structures and processes for incidents requiring inter-agency and international support for consumer protection. It is applicable to FDA and its collaborating agencies that may be required to provide assistance or conduct The Food Safety Emergency Response Plan (FoSERP) and its annexes constitute a food-hazards plan that establishes a single, comprehensive framework for FDA and its collaborating agencies for the management of incidents. It provides the measures, operating structures, roles and responsibilities, and mechanisms for direction and coordination of resources before, during, and after food safety events that pose a risk to human health. This plan is compatible with the Integrated Disease Surveillance and Response (IDSR)-Ghana and the National Public Health Emergency Response Plan (NPHERP) and shall be used to guide FDA and its collaborating agencies in conducting response operations for all types of incidents along the food chain. 1.3 SCOPE AND APPLICABILITY The FoSERP shall cover the full range of complex and constantly changing requirements in anticipation of or in response to all “incidents” that FDA and its collaborating agencies manages or participates in, including the following: National Food Safety Emergency Response Plan (FoSERP) Incidents, including large-scale emergencies and major disasters, will require full coordination of operations and resources of FDA and its collaborating agencies and may: a. Food and Drugs Authority, Ghana 4 emergency operations in the context of actual or potential incidents. In these cases, FDA and its collaborating agencies may use the Incident Command System (ICS) to facilitate command and coordination. The FoSERP applies to adverse events in the food chain and the exchange of information on food safety matters between FDA and its collaborating Agencies. 1.4 PLANNING ASSUMPTIONS The FoSERP shall be based on the following planning assumptions: Occur at any time with little or no warning in the context of a general or specific threat or hazard, Involve one or more agencies and span a single or multiple districts. Require relevant information sharing, resource coordination, and/or assistance across FDA and its collaborating agencies, the private sector, and foreign governments, Result in numerous casualties, fatalities, and displaced people; property loss; significant damage to the environment; and disruption of economy and normal life-support systems, essential public services, and critical infrastructure, Require rapid response and prolonged, sustained recovery operations and support activities. i. ii. iii. iv. v. Supporting documentations from respective agencies (e.g., standard operating procedures [SOPs], operations and procedural manuals, field guidance) shall be used to provide detailed instructions during performance of specific functions or incident-related actions All emergency-related activities will be initiated and conducted in accordance with the principles, concepts, and terminology established within Ghana’s Public Health Emergency Response Plan Regardless of incident characteristics or requirements, FDA continues to be responsible for consumer products under its jurisdiction while coordinating response operations with other relevant stakeholders. Contamination of food products may initially be indistinguishable from a naturally occurring event. Moreover, depending upon the particular agent and associated signs or symptoms, several days or weeks could pass before authorities suspect terrorism may be the cause. Response to a chemical, biological, radiological, or nuclear (CBRN) incident along the food chain suspected of being deliberate in origin or a terrorist act requires consideration of special law enforcement requirements as well as international legal obligations and requirements. The combined expertise and capabilities of government at all levels, industry, and nongovernmental organizations (NGOs) will be required to respond to incidents of catastrophic proportions. During such periods, NADMO will provide emergency support. b. c. d. e. 1.5 ACTIVATION OF FoSERP While many parts of this FoSERP may be used routinely to manage food emergency operations, the full plan will be activated when certain events occur such as, but not limited to, the following: Food and Drugs Authority, Ghana5 1.6.1. Ghana Health Service (GHS) The Public Health ACT 2012 (ACT 851) consolidate all the laws relating to public health to prevent disease, promote, safeguard, maintain and protect the health of humans and animals. It gives the authorizing agency the power to declare outbreaks, quarantine or isolate, institute control measures, vaccination, environment and sanitation and the establishment of the Food and Drugs Authority. 1.6.2. Food and Drugs Authority Part 7 of the Public Health Act, 2012 (Act 851), establishes the Food and Drugs Authority with the object of providing and enforcing standards for the sale of food, herbal medicinal products, cosmetics, drugs, medical devices and chemical substances. The Act also mandates the Authority to collaborate with other agencies in the manner in which foodborne diseases are to be reported. 1.6 KEY EMERGENCY RESPONSE AUTHORITIES Statutory authorities relevant to FoSERP are described below under the general categories. In addition, certain regulations may be particularly applicable in an emergency. A determination has been made by the FoSERP/OC based on Appendix 1 that FoSERP/OC emergency actions are warranted to prevent, prepare for, protect against, mitigate, respond to, or recover from a threat or hazard. The FoSERP Management Committee (FoSERP/MC) has assigned FDA and its collaborating agencies to provide emergency support to maintain the safety of the food supply chain. The FoSERP Management Committee (FoSERP/MC) has assigned FDA and its collaborating agencies to provide emergency support to protect the public health in the event of food product adulteration. The Counter Terrorism Unit of the National Security Council has raised the bioterrorism or hazard alert level. The President has declared a national emergency exists in accordance with Article 31 (1) and (2) of the constitution of the Republic of Ghana (1992) when an event warrants it (vide NADMO SOP for emergency). The CEO of FDA has, under Section 134 of the Public Health Act, 2012 (Act 851), determined that a food safety event presents a public health emergency, including significant outbreaks of infectious disease. The Director General of the GHS has determined that, the epidemic threshold of specific foodborne disease as stated in the IDSR-Ghana is exceeded. The Minister of Food and Agriculture has determined the outbreak of notifiable zoonotic disease. a. b. c. d. e. f. g. h. National Food Safety Emergency Response Plan (FoSERP) 1.6.3. GRA-Customs Division The Customs Act, 2015 (Act 891), Revenue Administrative Act, 2016 (Act 915) and Customs Regulations, 2016 (LI 2248) allow for Customs to conduct examination of goods, investigation, search, information acquisition and management, offence and their handling in relation to import and export of products including food. 1.6.4. Metropolitan/Municipal/District Assemblies (MMDAs) Local Government Act, 1993 (Act 462) and Local Government (Metropolitan /Municipal/District Assemblies) (Establishment) Instruments allows the Metropolitan/Municipal/District Assemblies (MMDAs) to be ultimately responsible for the development, improvement and management of human settlements and the environment in metropolis, municipalities and districts. Under the Public Health Act, the Food and Drug Authority is to monitor through the District Assemblies among others, compliance with the provisions of this Part 7 of the Act that deals with Food and Drugs. There are shared responsibilities with regard to meat inspection mandates for MMDAs with that of the Veterinary Services Directorate (VSD), which have been clarified in section 108 of the Public Health Act, 2012 (Act 851). This section mandates MMDAs to register slaughterhouses while the VSD in collaboration with the FDA carries out routines out meat inspection in slaughter houses. 1.6.5. Plant Protections Regulatory Services Directorate (PPRSD) The Plants and Fertilizer Act, 2010 (Act 803) allows the PPRSD to carry out surveillance of growing plants including areas under cultivation, fields, plantations, etc. particularly to report the occurrence, outbreak and spread of pests and the control of the pests; inspect consignments of plants and plant products and where appropriate other regulated articles to prevent the introduction and spread of pests. 1.6.6. Veterinary Service Directorate (VSD) The Diseases of Animals Act,1961 (Act 83) provides for the prevention and control of the spread of infectious and contagious diseases. Veterinary Services play a key role in the prevention and management of contagious animal diseases, zoonoses and foodborne zoonotic hazards. In addition to carrying out animal health and protection missions, they control the measures needed to ensure the subsequent safety of food products derived from these animals. They also design and implement a risk-based food safety system for food of animal origin. 1.6.7. Ministry of Fisheries and Aquaculture Development (MoFAD) The Fisheries Act, 2002 (Act 625) and Fisheries Regulations, 2010 (L.1. 1968) consolidate with amendments the law on fisheries, to provide for the regulation and management of fisheries, for the development of the fishing industry and the sustainable exploitation of fishery resources. It also sets up the Fisheries Commission. The Minister responsible for fisheries is given the power to enact regulations to implement the Act and enacted the Fisheries Regulations, 2010 (L.1.1968). The Regulations provides among others for the following: prescribe measures for the conservation, management, development, licensing and regulation of fisheries or a particular fishery, including total allowable catch and quota system as the Minister considers appropriate; establish rules on catching, loading, landing, handling, Food and Drugs Authority, Ghana 6 National Food Safety Emergency Response Plan (FoSERP) Food and Drugs Authority, Ghana7 National Food Safety Emergency Response Plan (FoSERP) transhipping, transporting, possession and disposal of fish; set rules on the importation, export, distribution and marketing of fish and fish products; prescribe standards relating to aqua culture, to recreational fishing or to canoe fishing including markings and identity of canoes; and prescribe rules relating to the control, inspection and conditions of operation of fish processing establishments. 1.6.8. Ghana Standards Authority-GSA The Ghana Standards Authority is established by the Standards Authority Act 1973 (NRCD 173) the National Standards Body under the Ministry of Trade and Industry with the overall responsibility for the country’s quality infrastructure embracing Standardisation. Metrology and Conformity Assessment (Inspection, Testing and Certification) in Ghana. The GSA is also the country’s administrator of weights and measures, weighing and Measuring instrument Act NRCD 326 of 1975. The objectives of the Authority are to; (i) Establish and promulgate standards to ensure high quality goods are produced in Ghana and imported into Ghana for consumption or export. (ii) To promote standardisation in industry and commerce to achieve industrial efficiency. (iii) To promote standards in public and industrial welfare, health and safety. GSA has accredited laboratories (ISO/IEC 17025) that conduct analysis on metallic contaminants and mycotoxins in foods, physicochemical analysis of food and agricultural products as well as microbiological analysis. Toxicological and pathological tests are also conducted by the GSA. 1.6.9. Environmental Protection Agency Environmental Protection Agency Acts/Laws for environmental emergencies such as chemical spillages on land which can get into the food chain. They are responsible for coordinating the chemical emergency response. 1.6.10. Ghana Atomic Energy Commission Ghana Atomic Energy Commission Acts/Laws with respect to all radioactive emergencies. They are responsible for coordinating the radioactive emergency response. The Ghana Atomic Energy Commission was established by an Act of Parliament, Act 204 of 1963, as the sole Agency in Ghana responsible for all matters relating to peaceful uses of atomic energy. The Act 204 was amended in 1993 by PNDC Law 308 mainly to enable it to create other institutes under the Commission. This amendment resulted in the creation of two other Institutes in addition to the National Nuclear Research Institute (NNRI) formerly Kwame Nkrumah Nuclear Research Institute (KNNRI). The two Institutes are the Radiation Protection Institute and the Biotechnology and Nuclear Agriculture Research Institute (BNARI). Other statutory bodies may be included when required. Food and Drugs Authority, Ghana 8 National Food Safety Emergency Response Plan (FoSERP) CHAPTER TWO 2.0 EMERGENCY OPERATIONS PHASES Food safety is the assurance the food will not cause when consumed according to its intended purpose. In providing this assurance emphasis should be on prevention and protection rather than curative. Hence the FoSERP should always be in the preventive and protective mode. The following phases comprise the entire spectrum of National food safety emergency operations: Prevention, Protection, Mitigation, Response, and Recovery. Although emergency operations may involve each of these phases over the course of any multitude of incidents, the nature and severity of an event and the organizational component(s) responding will determine the specific order, actions, and responsible parties required for each. 2.1. PREVENTION, PROTECTION, AND MITIGATION FDA and/or its collaborating agencies will integrate the prevention, protection, and mitigation phases. These three phases defined as follows: Prevention includes those capabilities necessary to avoid or stop a threatened or actual food safety emergency. Protection includes capabilities to safeguard the food chain against man-made acts and natural disasters including acts of terrorism. It is focused on actions to protect public health and safety. Mitigation includes those capabilities necessary to reduce severity of outbreak, loss of life and livelihood burden by lessening the impact of food safety emergencies. It is focused on the premise that individuals, the private sector, communities, critical infrastructure, and the nation as a whole are made more resilient when the consequences and impacts, the duration, and the financial and human costs to respond and recover from adverse incidents are all reduced. The “prevention, protection, and mitigation” phase involves immediate steps to protect consumers; ensure the safety and defence of food and animal feed, and other information to a range of directed countermeasures. Upon preliminary determination of an incident, FDA and its collaborating agencies shall conduct the following preventive/protective/mitigation measures: a. b. c. Conduct scientific vulnerability assessments of different categories of food to determine the most serious risks of contamination. Provide training to MDAs, industry, and other stakeholders. Intensify surveillance to detect adverse events, disease outbreaks, natural disasters, and other emerging and re-emerging public health concerns. a. b. c. 2.2. SURVEILLANCE, DETECTION, AND ALERT Within the context of this plan, increased risk-based “surveillance and detection” is defined as an increase in the frequency, quantity, or detail of the ongoing systematic collection, analysis, and interpretation of public health data essential to the planning, Food and Drugs Authority, Ghana9 National Food Safety Emergency Response Plan (FoSERP) execution, and evaluation of FDA emergency operations, closely integrated with the timely dissemination of these data to those responsible for prevention and control. FDA will use data from a variety of sources (e.g., GHS, VSD, PPRSD, Custom laboratory, Ghana Armed Forces Medical Services (GAFMS), GSA, MMDAs, International sources; consumer complaints, regulatory inspections, investigations, and sampling; laboratory testing) for passive and active surveillance of the food chain and other public health concerns during day-to-day situations and for targeted preventive actions. The focus of these systems is to detect a “signal” to allow for additional information gathering and analysis or to track and trace a suspected or confirmed event within the agency’s jurisdiction. They support FDA’s primary mission, including identifying and reviewing adverse events and tracking and tracing product problems, and are used to facilitate counterterrorism and product safety and security activities as appropriate. The FoSERP Operation Centre (FoSERP/OC), situated at FDA will be in constant state of readiness during routine agency operations, maintaining 24 hours a day, 7 days a week (24/7) monitoring capability for surveillance and detection. FoSERP/OC staff assist with the detection of signals either as the direct Point Of Contact (POC) for outside data sources or internally generated data and participate in meetings to identify emerging threats. Pre-identified incidents are assessed by FoSERP/OC staff to determine potential publichealth threats using the ‘Decision Instrument’ for the Assessment of food safety incidents that may constitute Public Health Emergency tool (Appendix 1). NADMO/EOC PH/EOC FoSERP/EOC Figure 2: Relationship between NADMO / EOC, PH / EOC and FoSERP / OC In addition, several databases and electronic information exchanges enable responsible FDA organizational components to collect and report out-of-the-ordinary information, monitor potential and ongoing situations, and determine whether agency emergency response activities are warranted (Table 1). Food and Drugs Authority, Ghana 10 National Food Safety Emergency Response Plan (FoSERP) Table 1: Surveillance and Detection Systems Utilized by FDA System Description Responsible MDAs Integrated Disease Surveillance and Response (IDSR) These are standard operating procedures that provide details on surveillance, investigations, diagnosis including laboratory and response to the occurrence of priority diseases and conditions. Data are generated at health facility and transmitted to the national level via the district and regional levels on periodic basis. GHS/DSD Laboratory analysis and data generation Laboratory analysis and data that pertains to primary animal production VSD Data generation Data that pertains to primary plant production PPRSD Customs Operation al Manual (Specific Annex H) This annex provides for information acquisition, examination of goods and persons, access to computerised database, offence handling, investigations, establishment and administrative procedures. Customs Division Laboratory analysis and data generation GSA analyse samples related to foodborne diseases. The outcome of analysis is communicated to FoSERP/OC for investigation response. The Authority generate data of potential contaminant to food GSA Laboratory analysis and data generation Laboratory analysis that pertains to radiations/radioactivity Ghana Atomic Energy Commission Laboratory analysis and data generation Laboratory analysis and data that pertains to primary fish production Fisheries Commission Media Scan A digital platform for scanning media channels for food safety alerts FDA communication 2.3. RESPONSE The “response” phase of FoSERP includes those immediate and sustained actions to ensure the safety of the food chain and to protect the public’s health throughout the duration of an incident. This phase generally involves the following four elements (figure 3) Receive Information and Maintain Situational Awareness Alert and Notification: Receiving information or intelligence confirming the development or occurrence of an incident and issuing notifications to agencies, stakeholders and partners. Food and Drugs Authority, Ghana11 National Food Safety Emergency Response Plan (FoSERP) Assessment and Monitoring: Performing initial and ongoing situation analysis, monitoring, and reporting. Activation and Deployment of Resources and Capabilities: Directing and mobilizing FDA and its collaborating agencies’ resources and capabilities, including Public Health Emergency Operation Centre (PHEOC), operational-level changes and implementation of the ICS in the field and/or National Level. Coordination of Response Actions: Conducting rapid and synchronized emergency response activities at National and field locations. Demobilization: Withdrawing FDA and its collaborating agencies’ resources (i.e., personnel, facilities, equipment, and other materials support) and returning them to their original location and status. Figure 3: Elements of the Food Safety Emergency Receive Information and Maintain Situational Awareness Ac�va�on and Deployment of Resources and Capabili�es Coordina�on of Response Ac�ons Demobiliza�on 2.3.1. Receive Information and Maintain Situational Awareness Alert and Notification FDA may be alerted to a threat, hazard, or other significant event through a variety of means, including the surveillance systems discussed in Table 1 and/or directly from international agencies (e.g. INFOSAN), industry, consumers, news media, and internal FDA organizational components. Any or all agency organizational components may receive information depending on the event’s scope and magnitude. Recipients of such information must handle it properly to ensure FDA is able to track and evaluate the situation. Failure to address a report in a timely fashion may delay emergency response and potentially exacerbate the incident. Depending on the scale of the incident, coordination of an incident will be managed by regional FoSERP Management Committee (FoSERP/MC) and notify National FoSERP/MC. The operational activities of FoSERP/MC will be done through the FoSERP/OC. Food and Drugs Authority, Ghana 12 National Food Safety Emergency Response Plan (FoSERP) Involve life-threatening adverse events or deaths possibly related to food. Involve a contaminant or pathogen associated with food. Involve injury, illness, or death across multiple regions or geographic locations. Involve food distribution across multiple regions or geographic locations. Involve a considerable number of producers or manufacturers or a firm of considerable size and extensive food or feed products distribution. Arise in circumstances in which it is difficult to quickly identify the source of the problem. Involve terrorist and/or criminal activities with potential to impact staff of FDA and its collaborating agencies, facilities, or regulated products. a. b. c. d. e. f. g. Certain types of incidents typically, but not necessarily always, should be reported to National FoSERP/OC as potential emergencies. These include incidents that: Assessment and Monitoring Once FoSERP/OC receive word of an impending, ongoing, or resurgent emergency situation, they must gather enough information to determine the validity and extent of the threat or hazard and the agency’s roles and responsibilities within the situation. FDA and its collaborating agencies will work together with other government agencies and industry to rapidly evaluate the situation and make these determinations. FoSERP/OC is responsible for coordinating with collaborating agencies and external partners to formulate an initial incident assessment. Results of this assessment may include a variety of Situation Reports (SitReps), healthcare records, research and analyses, maps, and surveillance information. This critical information is passed through established reporting channels to allow agency decision-makers to develop situational awareness and establish a “common operating picture.” Using GIS capabilities, an online or paper map-based common operating picture may be used to build and maintain situational awareness. The map-based common operating picture can visually depict response features with geographical reference in addition to the text information. Based on initial analysis of the threat or hazard, FDA and its collaborating agencies will take steps to monitor the situation, identify and prioritize requirements, and/or activate available resources and capabilities. Figure 4 depicts the methodology used to assess an incident and determine whether additional response activities are needed. Figure 4: National Food Safety Emergency Response Decision Tree. Incident Occurs Alert and Notification Initial AssessmentMonitoring Activation and Deployment of Resources and Capabilities National FoSERP Regional FoSERP Involve or implicate food? Raises security concerns? Have the potential for escalation? Have the potential to impact negatively on the food chain? Meet any other conditions that may apply? Implement emergency response plan Issue, evaluate and update response Continue monitoring the situation Provide updates as necessary Food and Drugs Authority, Ghana13 National Food Safety Emergency Response Plan (FoSERP) Whether food or feed product is implicated as the cause of the incident. Whether it is confirmed that food or feed products have been or may be affected. Whether medical countermeasures are expected to be used in response. Whether it involves food import and exports. Whether it involves unprocessed agro produce a. b. c. d. e. Determining Regulatory Authority. It is important to note that a reported incident may or may not be subject to FDA authority. Therefore, one of the first discussions to take place will include a determination of whether FDA has regulatory authority. Some of the criteria potentially used in the assessment include: Whether it involves unprocessed animal products Whether INFOSAN and/or foreign partners have formally requested FDA assistance. f. g. 2.3.2. Activation and Deployment of Resources and Capabilities As the agency’s central coordination point for emergencies, the FoSERP/OC operating status generally falls into one of three levels (District, Regional and National levels), depending on the severity or potential consequences of an incident or perceived threat. Investigation or confirmation of an incident with potential or confirmed public health impact may require activating a change in the EOC operational level from a readiness state of District to Regional or National, depending on the scope of the incident. Command Centers, and Rapid Response Teams shall follow the EOC operating levels when it is a food safety emergency. Depending on the locality or pathogen and complexity of an incident, activation of FoSERP management resources may be required. The FoSERP (typically District level), coordinates with Regional FoSERP and field components and the appropriate Center(s) in the review and analysis of information about threats and hazards and assists in the early recognition of emergencies, outbreaks, and terrorism or other criminal acts that may affect the food chain or public health. Authority to Change Operational Levels The authority to change the operational level of FoSERP/OC resides with the Minister of Health, or his/her designee. The Minister of Health or his/her designee will coordinate changes in operational levels with the respective level of FoSERP and the collaborating Ministry(s). The National FoSERP/OC shall be made aware when a Command Centres, and Rapid Response Team(RRT) are activated in response to an incident. Once FDA determines that it has regulatory authority, it shall coordinate the management of the incident else function in a supporting role. Although the agency may make an initial determination regarding authority and jurisdiction, it may continue to review and reconsider regulatory authority throughout an incident as it evolves, expands, or controlled. Food and Drugs Authority, Ghana 14 Food Safety Emergency Response Plan (FoSERP) FDA or its collaborating agencies has received credible intelligence or other confirmed information that a food product is the specific target of terrorism or other serious criminal activity. An incident involves a single or multiple food covering a large geographic or population area (more than one district or region) and requires the coordination of multiple agency or district/region. a. b. Conditions for Operational Level Change Any of the following conditions could affect the operational levels of the EOC or activation of the FoSERP: Two or more significant events have occurred at the same time. Food products or facilities have been impacted by a natural or manmade disaster. Deliberate or accidental contamination of the human or animal food products supply has caused widespread illness, injury, or death to consumers. A widespread epidemic or pandemic disease outbreak or other public health emergency for which FDA or its collaborating agency has responsibility for has occurred or is highly probable. c. d. e. f. 2.3.3 Coordination of Response Actions FoSERP/OC must perform a number of tasks and functions when responding to an incident (see Guidelines For Handling Foodborne disease outbreaks-FDA/FSMD/GL-FBD/2012/01, National Recall Plan and IDSR-Ghana). Some of these basic tasks may include performing initial and ongoing planning, managing and performing assignments, coordinating team response operations and resources, performing research and decision-making, and documenting and reporting information. Initial and Ongoing Response Planning FoSERP/MC conducts planning to organize its response structure, identify objectives and performance metrics, and coordinate the delivery of resource support. Planning is ongoing throughout the lifecycle of any incident and is adjusted as necessary to meet changing demands. It involves a blend of prescribed actions drawn from existing emergency plans and procedural documents (e.g., hazard-specific incident, SOPs, operations manuals, field guides) and real-time determination of the necessary course(s) of action. An Incident Action Plan (IAP) may be developed based on these actions to provide operational and tactical direction to Rapid Response Team personnel when responding. The FoSERP/OC will notify appropriate collaborating agency when the EOC operational level has been changed. This activation announcement may include a status report explaining the rationale for the decision to change the EOC operational level. After activation procedures commence, the FoSERP/OC of a particular level may request additional resources and capabilities to augment emergency operations from the next level. Food and Drugs Authority, Ghana15 National Food Safety Emergency Response Plan (FoSERP) The IAP is generally crafted by holding regular planning meetings throughout the incident, both in-person and via conference calls. Planning meetings seek to accomplish the following goals: Gathering, recording, analyzing, and distributing incident information in a manner that will facilitate: (1) increased situational awareness of the magnitude, complexity, and potential impact of the incident, emergency, or crisis; and (2) the ability to determine the resources required to resolve the situation. Formulating and prioritizing measurable incident objectives and identifying an appropriate response strategy that conforms to the legal obligations and management objectives of all FDA and its collaborating agencies involved. Determining the tactical direction, reporting mechanisms, timeframes, and specific resource requirements (i.e., personnel, specialized equipment, facilities, training and expert knowledge, and funding) for implementing selected strategies during the response period. Through these planning meetings, FoSERP/MC shall coordinate the execution and evaluation of emergency activities, promote and maintain situational awareness, track the progress of ongoing initiatives, and modify plans and procedures based on new and emerging information. For incidents involving both National/Regional and District response, IAPs will generally be developed by district FoSERP, while an Incident Coordination Plan (ICP) may be developed by the National/Regional FoSERP that outlines incident objectives from a National/Regional level perspective (e.g., support of field operations). Field/District Response For the majority of incidents involving food, one or more agencies’ field offices may be involved in the response. The districts in which the event is occurring (i.e., the physical location where people have been affected) will obtain necessary information for FoSERP to confirm the health hazard. In addition, the RRT will determine, plan, and conduct tasks and assignments over the course of the response. Rapid Response Team (RRT): A decision can be made to respond by implementing ICS at the field level, which involves the activation of one or more RRTs. An RRT utilizes an incident command structure made up of the Command, General Staff members, and appropriate functional units. Criteria for activating an RRT will be based on the conditions described in Section on “Scope and Applicability.” The authority to mobilize an RRT resides with FoSERP/MC. The RRT will be responsible for tactical operations (i.e., perform investigations/inspections, collect samples, and/or detain or destroy contaminated product) in accordance with the IAP developed. In addition, as the RRT conducts its follow-up efforts, field offices will communicate investigational/ inspectional findings of other potentially affected establishments with the FoSERP/OC. a. b. c. Food and Drugs Authority, Ghana 16 National Food Safety Emergency Response Plan (FoSERP) Information Collection, Evaluation, and Dissemination: Collecting, analyzing, interpreting, and Disseminating information from/to various internal and external sources. Priority Setting: Ensuring that agency response systems are a. b. The RRT is led by a designated Incident Commander (IC) (see Section on “Field Incident Command,” for organizational elements). The field IC reports directly to the Head of the FoSERP/OC. The IC coordinates activities with the Head of the FoSERP/OC (when activated). Communications may be conducted through teleconference calls, emails, and/or SitReps. National/Regional Response Depending on the nature and complexity of the response to an incident, an intra-agency or inter-agency approach may be used to coordinate resources and incident-related information and to support incident management and agency policies. Depending on the scale of the incident, National/Regional coordination will be managed by National/Regional FoSERP/MC or other locations as circumstances may require. EOC: The FoSERP/OC at the FDA is the physical location at which the coordination of information and resources to support incident management activities normally takes place. FoSERP/MC: The FoSERP/MC is responsible for managing the District’s/Program’s emergency response effort, coordinating actions and resources needed to follow up on the incident, and channelling all necessary communications to/from deployed field elements. Depending on the nature and severity of the incident, additional field RRTs may be established to support geographically distant or functionally different emergency response operations. FoSERP/OC: The FoSERP/OC serves as the agency-wide focal point for emergency operations coordination and dissemination of information. The FoSERP/OC staff monitor ongoing events, processes complaints and alerts, issues assignment to FoSERP stakeholders, coordinates overall food safety emergency management operations, and communicates with interagency partners to provide technical and material support. The FoSERP/OC facilitates contact between applicable stakeholders and field emergency personnel and provides frequent and formalized communications/reporting to senior government officials and international organizations, regarding the status of food safety emergency response activities. The FoSERP/OC does not command or control the agency’s response, but carries out the coordination function for complex incidents or multiple incidents occurring simultaneously through: interconnected and complementary, reinforcing interoperability among the various FoSERP stakeholders, making the response more efficient and effective by coordinating available resources, and making decisions based on agreed-upon policies and procedures. Food and Drugs Authority, Ghana17 National Food Safety Emergency Response Plan (FoSERP) Identifying whether consumer product safety and security and public health protection objectives were achieved An orderly, safe, and efficient return of resources of FDA and its collaborating agencies (i.e., activated or deployed personnel, facilities, and equipment) to their original locations and/or operating status is warranted. a. b. interconnected and complementary, reinforcing interoperability among the various FoSERP stakeholders, making the response more efficient and effective by coordinating available resources, and making decisions based on agreed-upon policies and procedures Resource Coordination: Identifying and acquiring needed resources and allocating existing or known resources. Communications Facilitation: Establishing and maintaining intra and interagency interoperable communications. c. d. 2.3.4 Deactivation/Demobilization As the need for full-time incident response coordination wanes, FoSERP/MC will assess the situation to determine whether to continue or terminate food safety emergency repsonse operations. This decision includes; 2.4 RECOVERY The “recovery” phase of FoSERP operations includes short- and long-term actions to ensure and restore the safety and availability of food and to protect the public’s health. As FoSERP operations conclude, requests for more detailed assessments, technical assistance, and longer-term coordination fall under the recovery mission. Subject matter expertise and technical assistance can be provided to address issues that impact on food industries. FDA and its collaborating agencies will work with NADMO to provide a coordinated and consistent approach to recover rtfrom an incident. FoSERP/OC will collaborate and maintain communication with other government agencies, industry, the public, and the media particularly concerning any long-term effects associated with the event. Recovery objectives are outlined below: In making this decision, FoSERP/MC coordinates with and seeks input from appropriate experts and stakeholders. Deactivation of an RRT may be done through written correspondence, email, phone calls etc. from the FoSERP/OC. Depending on the incident, resurgence may occur, and any period of transition back to normal operations could be disrupted. When this occurs, FoSERP/OC will begin a new “notification and alert” period for food safety emergency response and a change in EOC operational levels may occur. Transition back to normal operations, after initiating and conducting a food safety emergency response, will occur in stages and will correspond to the recovery of affected communities, FDA-regulated firms, and the Nation as a whole. Food and Drugs Authority, Ghana 18 National Food Safety Emergency Response Plan (FoSERP) Health and Social Servicesa. i. ii. Inspect or investigate food facilities and collect and analyze samples for the overall recovery operation as needed. Oversee product destruction and product reconditioning or rendering as appropriate. Infrastructure Systemsb. i. ii. Identify key facilities that manufacture/process, pack, hold or distribute food for human or animal consumption and determine if any are critically impacted. Provide clear and consistent information to assist industry in understanding and complying with regulations in a post-disaster environment. 2.4.1 Evaluation of Response Following any food safety emergency, FDA and its collaborating agencies will discuss how the FoSERP/OC handled the incident and seek input from appropriate experts and stakeholders. Participants will analyze food safety emergency actions and responsibilities, resolve any deficiencies, mitigate consequences, and anticipate and address any long-term effects of the incident. In addition, organizational policies, plans, and procedures will be updated as needed, incorporating lessons learned and best practices captured during the event. After termination of response activities, a lesson learned analysis should be conducted to identify the following: Dependent on the recovery objectives and the level of coordination needed, the FoSERP/MC will determine the resources needed to support the functioning of the recovery efforts. As the need for recovery coordination wanes, FDA and its collaborating agencies will assess whether consumer product safety and security and public health protection objectives were achieved. The transition back to a steady state operation will occur in stages and will correspond to the reestablishment of public confidence in the food chain. With regards to the recovery of the food industry, it may be more appropriate that long-term recovery activities requiring FDA involvement be coordinated by responsible department. Strengths and weaknesses of key response activities performed during the incident, including agency measures to protect public health. Resource needs (e.g., personnel, logistics). Improvements to emergency response plans and procedures. Strengths and weaknesses of agency communications, which could include intra-agency and interagency communications as well as communications with specific stakeholder groups, such as industry, consumers, and the news media. Needed modifications toward regulatory policy, laboratory and field operations, and research activities. Any other needed improvements to overall preparedness. a. b. c. d. e. f. Food and Drugs Authority, Ghana19 National Food Safety Emergency Response Plan (FoSERP) CHAPTER THREE 3.0 ORGANIZATION AND THEIR RESPONSIBILITIES This section identifies the general roles and responsibilities of FDA and its collaborating agencies including those that assist in preventing and protecting against, responding to, and recovering from all hazards. FDA staff work closely with one another and its collaborating agencies and industry partners to ensure the safety of the food chain to mitigate the public health effects of any food safety emergency. FDA and its collaborating agencies have various functions in the implementation of the FoSERP and these are as follows: 3.1. MINISTRY OF HEALTH The Ministry of Health shall reinforce food-borne disease surveillance system in collaboration with other relevant ministries, departments and agencies and contribute to an effective and efficient system under the National Food Safety Policy. 3.1.1. Ghana Health Service Facilities under the Ghana Health Services shall be used to contribute towards the early warning system for disease control and assist in data and/or sample collection on patients visiting the health facilities during food safety emergencies. The Public Health Laboratories such as Accra, Tamale, Kumasi and Sekondi, shall analyse all clinical samples that may be collected from patients during food safety emergencies and forward results to the FoSERP/OC. 3.1.2. Food and Drugs Authority (FDA) FDA is responsible for promoting and protecting public health by ensuring that the Nation’s food supply is safe. FDA is the national authority mandated to regulate establishments that manufacture, prepare, process, pack, transport or store food for human and animal consumption. In a food safety emergency, FDA shall: Identify and characterise the hazard(s) giving rise to the incident Routinely submit data on foodborne disease collected at the health facilities to FoSERP/OC for analysis. Through the National Sample transport system, samples collected during food safety emergencies will be transported to respective laboratories for testing and feedback given. Developing and evaluating analytical methods for identifying food pathogens. a. b. c. d. Collaborate with other public agencies and industry regarding food contaminants and other monitoring programs for foodborne illness. Provide critical information on food safety, food defence, and regulatory issues to consumers, industry, governmental and international entities (Postproduction stage of the food chain). Protect the postproduction levels of food chain through regulatory, legal, and administrative actions. a. b. c. Food and Drugs Authority, Ghana 20 National Food Safety Emergency Response Plan (FoSERP) 3.2. GHANA REVENUE AUTHORITY - CUSTOMS DIVISION The Customs Division serving as the gatekeepers of the country performs several functions, including safety, security and enforcement of several regulations and directives. In the event of a Food Safety Emergency, Customs shall: Coordinate response activities critical to the safety and defence of the food supply at the post-production stage of the food chain. Use import alerts to prevent unsafe food from entering the country. Facilitate the coordination of food contamination investigations by collaborating with other agencies. Identify high risk foods and investigate the effectiveness of food processing and preparation practices. Develop and disseminate recommendations on measures to prevent the contamination of food. Coordinate the Development and Validation of analytical methods for identifying food contaminants. Host the National and Regional FoSERP/OC secretariat. In collaboration with other agencies provide the necessary resources for the proper functioning of the FoSERP/OC. Collaborate with other agencies to analyse food samples that may be collected during food safety emergencies Facilitate the training of Food Safety Emergency Response personnel. Conduct food enforcement activities at processing, manufacturing, storage and retail facilities during food safety emergencies Identify and characterise the hazard(s) giving rise to the incident Collate and maintain a database on all food safety incidents and emergencies d. e. f. g. h. i. j. k. l. m. n. o. p. Ensure that goods affected and /or unsafe for use are not released for export or import until they are declared safe for such, after analysis by the FoSERP/OC and a permit/certification and / or clearance has been issued by the statutory regulatory authority (case specific). Identify the transportation placard(s)/labels/markings indicating radioactive or other hazardous materials and UN logo at entry points/borders. Ensure that food or goods in Customs controlled areas rendered unsafe as a. b. c. 3.3. MINISTRY OF INTERIOR (POLICE, BNI) The Ministry is to ensure that FDA and its collaborating agencies are supported in the d. e. f. g. h. result of the event are not released for home consumption and / or export. Supervise the destruction of custom business goods, rendered unsafe by the event after approval by the case specific authority Assist to identify contaminated / infested/ affected goods and/ or individuals for screening. Prepare report for notification of the FoSERP/OC or response Team concerning unsafe foods Identify and characterize the hazard(s) giving rise to the incident Routinely submit data on food related issues collected to the FoSERP/OC. Food and Drugs Authority, Ghana21 National Food Safety Emergency Response Plan (FoSERP) areas of personnel and physical security during food safety emergencies. In addition, the Ministry shall plan for continuous operations in the face of an emergency and ensure that public health is protected to the greatest extent possible through collaboration with FoSERP/OC. It shall also; a. b. c. Provide intelligence to the FoSERP/OC on any emerging food safety threats. Identify and characterize the hazard(s) giving rise to the incident Routinely submit data on food related issues collected at the productions stage of the food chain to the FoSERP/OC. 3.5. GHANA ARMED FORCES The Office of the GAFMS shall provide the FDA and its collaborating agencies the necessary support in the areas of personnel and physical security during food safety emergencies. In addition, the Office shall plan for continuous operations in the face of a crisis and ensure that public health is protected to the greatest extent possible through coordinating emergency response activities involving food. It shall also provide intelligence of the FoSERP/OC on any emerging food safety threats. 3.4. NATIONAL SECURITY SECRETARIAT It shall provide intelligence to the FoSERP/OC on any emerging food safety threats. a. b. c. GAFMS shall assist in the case management of foodborne diseases during outbreaks GAFMS shall through NADMO provide emergency logistical support and specialised services. GAFMS shall identify and characterize the hazard(s) giving rise to the 3.6.1. The Veterinary Services Directorate (VSD) VSD plays a central role in ensuring food safety, especially the safety of food of animal d. incident within Ghana Armed Forces Routinely submit data on food related issues collected at all stages of the food chain to the FoSERP/OC. 3.6. MINISTRY OF FOOD AND AGRICULTURE The Ministry of Food and Agriculture (MoFA) is the lead agency and focal point of the Government of Ghana, responsible for developing and executing policies and strategies for the agriculture sector within the context of a coordinated national socio-economic growth and development agenda. In this regard, MoFA facilitated the preparation of the Food and Agriculture Sector Development Policy (FASDEP II) and the Medium-Term Agriculture Sector Investment Plan (METASIP 2010-15) One of the main objectives of the Ministry as stated in the FASDEP document is Food security and Emergency preparedness. Two agencies of the Ministry are directly involved in ensuring delivery of safe food to the public-locally and internationally. They are the Veterinary Services and Plant Protection and Regulatory Services Directorates. Food and Drugs Authority, Ghana 22 National Food Safety Emergency Response Plan (FoSERP) origin. In the design and implementation of a risk-based safety system for food of animal origin these are the roles and responsibilities of VSD. a. Primary production Through their presence on farms and collaboration with farmers, Veterinary Services play a key role in ensuring that animals are healthy and kept under good sanitary and hygienic conditions. Veterinary Services shall; i. ii. iii. iv. play a key role in biosecurity and early detection, surveillance and treatment of animal diseases, including conditions of public health significance. provide direction to farmers on practices that prevent or reduce physical and chemical hazards (for example, mycotoxins, environmental contaminants and pesticide residues) in primary production, including feed. ensure responsible and prudent use of veterinary medicinal products, including antimicrobial agents . This helps to reduce the likelihood of noncompliant levels of veterinary drug residues in food of animal origin and the development of antimicrobial resistance. ensure traceability throughout the food chain by verifying animal identification. b. Slaughter: Veterinary Services shall; i. ii. iii. Conduct inspection of live animals and their carcasses to reduce foodborne risks to public health. This is to be provided by supervision and verification of process control and direct involvement in operational activities such as ante-and post-mortem inspection. Control or reduce biological hazards of public health and animal health importance by ante- and post-mortem inspection. Conduct surveillance for animal and zoonotic diseases in ensuring the safety and suitability of meat and animal by-products for their intended uses. c. Assurance schemes and certification of food of animal origin for international trade. i. Veterinary Services shall oversee assurance schemes in certifying that food of animal origin at the primary production level complies with animal health and food safety standards. d. Foodborne disease outbreaks: Veterinary Services shall;. i. ii. Investigate and respond to foodborne disease outbreaks which may be attributable to or involve animal products at the primary production level, including the implementation of control measures in close collaboration with public health professionals, laboratory analysts, epidemiologists, food producers, processors and traders and any others involved. Work with other national agencies in reporting to international emergency foodborne disease networks, such as OIE, INFOSAN, and in utilizing such information for preparedness. Food and Drugs Authority, Ghana23 National Food Safety Emergency Response Plan (FoSERP) 3.6.2. Plant Protection and Regulatory Services Directorate (PPRSD) In an emergency, PPRSD shall; iii. iv. Identify and characterize the hazard(s) giving rise to the incident Routinely submit data on food related issues collected at the productions stage of the food chain to the FoSERP/OC. i. ii. iii. iv. v. Protect plant health through regulatory, legal, and administrative actions. Coordinate response activities critical to the safety of unprocessed agro produce at the primary production stage of the food chain. Use import alerts to prevent unsafe unprocessed produce from entering the country. Provide information on critical safety and regulatory issues to stakeholders, consumers, industry and other government officials. Coordinate surveillance, response, and post-response activities related to incidents involving plants and their produce at the primary 3.6.3 Ministry of Fisheries and Aquaculture Development (MoFAD) In an emergency, MoFAD shall; vi. vii viii ix production level. Provide technical advice and assistance in the assessment of plants possibly affected during food safety emergencies. Prevent and control the spread of diseases among plant by declaring a district, area or place to be an infected area where an outbreak has occurred. Identify and characterize the hazard(s) giving rise to the incident Routinely submit data on food related issues collected at the productions stage of the food chain to the FoSERP/OC. i. ii. iii. iv. v vi. vii viii ix Protect fish health through regulatory, legal, and administrative actions. Coordinate response activities critical to the safety of unprocessed fish at the primary production stage of the food chain. Use import alerts to prevent unsafe unprocessed fish from entering the country. Provide information on critical safety and regulatory issues to stakeholders, consumers, industry and other government officials. Coordinate surveillance, response, and post-response activities related to incidents involving fish and their products at the primary production level. Provide technical advice and assistance in the assessment of fish possibly affected during food safety emergencies. Prevent and control the spread of diseases among fish by declaring a district, area or place to be an infected area where an outbreak has occurred. Identify and characterize the hazard(s) giving rise to the incident. Routinely submit data on food related issues collected at the production stage of the food chain to the FoSERP/OC. Food and Drugs Authority, Ghana 24 National Food Safety Emergency Response Plan (FoSERP) 3.7 GHANA STANDARDS AUTHORITY GSA is the National Statutory Body responsible for the development and promulgation of National standards with the objective of ensuring high quality of goods in Ghana. During food safety emergencies the GSA shall: i. ii. iii. iv. Identify and characterise the hazard(s) giving rise to the incident Analyse samples (food, tissues etc.) that may be collected Routinely submit data collected on food to the FoSERP/OC. Develop and validate test methods, as well as adopt internationally recommended analytical methods for identifying food contaminants . 3.8. GHANA FIELD EPIDEMIOLOGY & LABORATORY TRAINING PROGRAMME The schools of public health and other collaborators through the GFELTP shall: i. ii. Train field staff in the investigation and control of foodborne outbreaks Support lead agencies in field investigations 3.9. FOOD BUSINESS OPERATORS Food business operators shall be aware of the legal obligations set out in Part 7 of the Public Health Act, 2012 (Act 851). They shall abide by the requirements regarding food recall notifications and maintenance of food recall and traceability systems. i. ii. iii. iv. v. vi. vii. viii. Take all necessary measures to protect public health. Maintain all process documentation and product testing and traceability documentation. Notify the relevant official agencies and/or the FoSERP/OC of incidents or potential incidents without delay. Initiate the withdrawal and/or recall of products as necessary. Provide all necessary assistance and co-operation to an investigating agency. Ensure timely release of information relevant to an investigation. Review and update information as it becomes available and ensure investigating agencies are notified during incidents. Not offer for sale and/or distribute food which does not comply with the provision of any regulation applicable to that particular food. Food and Drugs Authority, Ghana25 National Food Safety Emergency Response Plan (FoSERP) CHAPTER FOUR 4.0 DIRECTION, CONTROL, AND COORDINATION FoSERP/OC organizes emergency response operations in accordance with the concepts, principles, and terminology of the FoSERP, as defined within IDSR. Incident Command and subordinate Planning, Operations, Logistics, and Finance/Administration functions lay the foundation for the FoSERP/OC implementation of the FoSERP during a food safety hazard response, at national, regional and district levels, and across geographic divides. The inherent design of this system enables rapid, scalable, and flexible interagency-wide emergency management activities. Figure 5 depicts FoSERP emergency response, command and coordinating structures and are followed by a brief description of each designated FoSERP/OC position. This section of the FoSERP describes FoSERP/OC application of the FoSERP. It is important to remember that two key principles of FoSERP are its scalability and flexibility. Food safety emergency situations can be unpredictable and dynamic. To accommodate this, the FoSERP operational structure was developed to be expanded easily from a very small size for routine operations to a larger operation capable of handling catastrophic events. Therefore, FoSERP organizational structure, while containing certain core positions, must be tailored to the specific requirements of each incident. 4.1. FoSERP/MC The FoSERP/MC consist of high-level management representatives from selected institution, and they come together during emergency to develop the Incident Action Plan (IAP) for the management of the emergency. Refer to appendix 7 for the composition of FoSERP/MC. The FoSERP/MC shall activate the FoSERP through the FoSERP/OC and RRT during an emergency. They shall provide policy direction during emergency and determine when emergency is over, for demobilisation. The FoSERP/MC shall mobilise all the necessary resources needed for responding to the emergencies and this shall be included in the IAP. 4.2. FoSERP/OC FoSERP/OC will be situated in FDA to provide secretarial support to the FoSERP/MC. They shall assess each alert receive to categorise it as incident or emergency. When alert is classified as emergency, the FoSERP/OC shall convene the FoSERP/MC within 24hrs to develop the IAP. They shall coordinate the implementation of the IAP during emergencies and serve as liaison between the field incident command and the FoSERP/MC. The FoSERP/OC shall be established at the National and Regional offices of FDA. However, at the District level, it shall be established at the office of the Health Directorate. Regardless of the level of FoSERP/OC involve in response to an incident, all FoSERP/OCs have five key functions. These functions include: Direction and Control: Provide control and direction for complex or multi-agency incidents. Serves as a single POC for prioritizing incidents and for facilitating access to critical resources. 1. Figure 5: FDA Field Incident Management Team Food and Drugs Authority, Ghana 26 National Food Safety Emergency Response Plan (FoSERP) 4.3. FIELD INCIDENT COMMAND The use of Incident Command in the field is achieved through the establishment of an RRT at appropriate field location(s) to determine field incident response objectives and execute the tactical strategy for responding to an incident per the FoSERP/OC ‘s priorities (see guideline for composition of RRT). The RRT is led by a field IC who operates under the authority of FoSERP/MC via a delegation of authority during an activation and is responsible for the overall management of the incident at the field level. FoSERP/OC may be represented by a District Director of Health Services (DDHS) working with the relevant collaborating agencies. Depending on the scope and scale of the incident, the FoSERP/OC will coordinate with national FoSERP/OC. An RRT functions in accordance with FoSERP principles; it is scalable and flexible based on the complexity of the incident. The FoSERP/OC may establish Operations, Planning, Logistics, and/or Finance/Administration Sections with subordinate positions, as needed, to manage on-the-ground response. Direction and Control: Provide control and direction for complex or multi-agency incidents. Serves as a single POC for prioritizing incidents and for facilitating access to critical resources. Information Collection and Evaluation: The FoSERP/OC serves as a central point for collecting, analysing, and interpreting information from a variety of sources. Coordination: The FoSERP/OC play a key role in coordinating the information flow and resources for complex incidents or multiple incidents occurring simultaneously. Priority Setting: The FoSERP/OC prioritizes incidents and critical resources using the priorities established by RRT and use these priorities at the policy level. Resource Management: Manage resources in line with incident priorities. Resource management includes identifying and acquiring needed resources in addition to allocating existing or known resources. 1. 2. 3. 4. 5. Food and Drugs Authority, Ghana27 National Food Safety Emergency Response Plan (FoSERP) 4.3.1. Command Staff The command staff consists of the Operations Officer, Safety Officer and Communication Officer. When assigned, they report directly to the Incident Commander and provide information, safety, and liaison services in support of the incident. 4.3.2. Incident Commander The IC is responsible for the overall management of the incident and for providing direction and guidance to the Command and General Staffs. The IC assigns the Operations, Planning, Logistics and Finance/Administration Section chiefs as needed. When these positions are not filled, the IC is responsible for accomplishing or managing these aspects of the incident organization. The IC must assess the overall requirements of the incident and determine the best course of action for the incident management team to pursue. The key responsibilities of the IC are to establish priorities, determine incident objectives and direction for managing the incident, and to approve and authorize the implementation of the IAP. Operation Officer For incidents that may be multi-agency, an Operations Officer may be assigned as the point of contact for supporting agencies and/or the various field units. The Operations Officer’s primary function is to establish and coordinate interagency contacts and report to the Incident Commander. Safety Officer The Safety Officer monitors incident operations and advises the IC on all matters relating to operational safety. The SO has the authority to immediately alter, delay, suspend, or terminate any and all operations that pose a danger to the life and health of RRT. Risk Communication Officer (RCO) Within the IDSR are specific policies for handling public information. The RRT RCO works with the appropriate Health Promotion Unit to coordinate message development and dissemination as applicable. The RRT RCO maintains an accurate account of information about the incident to inform and update the incident commander or Public Health EOC (if activated). 4.4. MULTI-AGENCY COORDINATION 4.4.1. National Level Many of the incidents to which FoSERP/OC responds involve other agencies that have a stake in providing response or needed resources. If the food safety emergency involves cross- agency jurisdictional lines, the FoSERP system shall be used to support a unified coordination of operations. The primary function of the FoSERP/OC is to coordinate activities above the field level and to prioritize incident demands for critical or competing resources, thereby assisting the coordination of field operations. In this unified coordination approach, representatives from FDA and each needed collaborating institution meet to set goals and decide how each institution can contribute to the achievement of the goals. There can be strong, formal command and Food and Drugs Authority, Ghana 28 National Food Safety Emergency Response Plan (FoSERP) control relationships between and among the agencies, or the command-and-control linkages can be informal but structured arrangements that recognize National responsibilities. It can be as simple as a teleconference or, alternately, require an assembled group and associated support systems. Such an assembled group (FoSERP/MC) comprises senior officials from the institutions involved in the response who are brought together by FoSERP/OC providing guidance to individual institution Incident Command groups on policy, resource allocation, and communications. The FoSERP/MC shall be supported by the Minister of Health/CEO of FDA, who will supervise the Group’s Situational Assessment and Resource Information Units that collect and assemble information needed for the emergency response team to fulfil its mission. This Information Unit would obtain such information from collaborating agencies /RRT. The FoSERP/MC may also have its own Public Information Unit to coordinate summary information and access to information sources with the media and other governmental entities. The results of the FoSERP/MC deliberations are distributed by its members directly to their own organizations as well as through the normal chain of command (e.g., EOCs, Incident Command/ Coordination Groups, etc.). 4.2.2. Regional and District FoSERP shall be implemented and coordinated at the district and regional levels using the same structures as that of the national level. Regional and district institutional representatives shall constitute the FoSERP/OC and FoSERP/MC. 4.2.3. Institutional Collaboration Table 2: Events and the lead Institution responsible Event Collaboration Institution FDA, GHS, NADMO, VSD, PPRSD, GSA, CUSTOMS DIVISION, MMDAs Identification and registration of cases Primary Production (Crop) Regular Case Specific PPRSD FDA, GHS, NADMO, EPA, MoFA, GSA, CUSTOMS DIVISION, MMDAs, Collaborating Laboratories Primary Production (Animal) VSDFDA, GHS, NADMO, GSA, CUSTOMS DIVISION, MMDAs, Collaborating Laboratories Primary Production (Fish) MoFADFDA, GHS, NADMO, GSA, CUSTOMS DIVISION, MMDAs, Collaborating Laboratories Post-Harvest/Post Slaughter Operations FDA GHS, NADMO, VSD, EPA, GSA, CUSTOMS DIVISION, MMDAs, Collaborating Laboratories Food related human health events GHS FDA, NADMO, VSD, PPRSD, GSA, CUSTOMS DIVISION, MMDAs, GPS, Collaborating Laboratories, Schools of Public Health-GFELTP Lead Institution Food and Drugs Authority, Ghana29 National Food Safety Emergency Response Plan (FoSERP) Figure 6: The Food Chain and the Lead Institution during Food Safety Emergency Response 4.2.4. Institutional Planning and Co-ordination Collaborating institutions will have arrangements or procedures in place to deal with the receipt of incident notifications and will investigate accordingly. The Lead/investigating institution will be responsible for identifying the hazard(s), and notifying FoSERP/OC. Incidents should be dealt with using the principles of Appendix 1. In order to categorise incidents in operational levels for management purposes, consideration will be given to the health impact posed and to the scale and nature of the food distribution per the IDSR/Appendix 1. In deciding where the responsibility for managing an incident lies the hazard characterisation and distribution of food associated with the incident per regulator responsibility (Table 1.1) shall be used as a guide. Hazard characterizsationcha can be High, Medium or Low High – where the adverse health effects are likely to be severe and immediate (e.g. E. coli O157, C. botulinum, acutely toxic chemicals, presence of allergens) The distribution of the food can be considered in the context of the enforcement remit of the lead institution and classified as ‘Limited’ or ‘Wide’ distribution. Medium – where the health effects are likely to be less serious or relate to continuous long term exposure or consumption of large quantities of food (e.g. chemical contaminants such as pesticides) Low – where the health effects are minimal or not observable (e.g., chemical residue levels which are above statutory limits, but which do not pose a health risk or foreign object contamination) Food and Drugs Authority, Ghana 30 National Food Safety Emergency Response Plan (FoSERP) Limited distribution – where the food is distributed in a localised area under the responsibility of one official agency (such as a bakery operating with the boundary of one region). Wide distribution – where the food is distributed such that more than one official agency has responsibility or where food has been distributed outside two or more regions. 4.6. MALICIOUS TAMPERING/INTENTIONAL CONTAMINATION OF FOOD Malicious tampering and intentional contamination of food is a criminal offence and is a matter under the remit of a CID of Ghana Police Service. The FDA has a working arrangement with the CID I on investigating such matters. Investigating agencies which become aware of an incident which may be the result of malicious tampering and/or intentional contamination of food should notify the FDA immediately. Safety Officer – The Safety Officer monitors incident operations and advises the IC on all matters relating to operational safety. The SO has the authority to immediately alter, delay, suspend, or terminate any and all operations that pose a danger to the life and health of RRT. Risk Communication Officer (RCO) – Within the IDSR are specific policies for handling public information. The RRT RCO works with the appropriate Health Promotion Unit to coordinate message development and dissemination as applicable. The RRT RCO maintains an accurate account of information about the incident to inform and update the incident commander or Public Health EOC (if activated). The responsibility for carrying out investigation and liaison at local level will be with the lead institution. Such institution may request assistance from other FoSERP/MC stakeholders regardless of the risk or distribution associated with any incident. Where there is necessary collaboration with the FoSERP stakeholders in managing an incident, investigations will continue to be carried out by the lead institution with support from the FDA. In many cases, a lead institution may not be aware of the full nature of the distribution or risk when initially investigating a food incident. Institutions are encouraged to use the ‘precautionary principle’ approach. If during the course of investigation, officers believe that there are wider implications than the evidence suggests they should notify the FoSERP/OC of the circumstances at the initial phase of the investigation. As much detail as possible should be provided and updates be made available. An investigating institution may need to re-categorise the incident on the basis of information as it becomes available. 4.5. MULTIAGENCY COORDINATION FOR FOODBORNE ILLNESS OUTBREAKS Multiagency Coordination for foodborne illness outbreak shall be done in accordance with the Guidelines for Handling Foodborne disease outbreaks FDA/FSMD/GL-FBD/2012/01(see appendix 2) 4.7. FOOD ALERTS AND RECALLS The FDA may become aware of a food hazard through food related illness, INFOSAN Food and Drugs Authority, Ghana31 National Food Safety Emergency Response Plan (FoSERP) notifications, directly from a food producer in Ghana, any of the collaborating agencies, food control laboratories or any other source. Where there is a need for action to be taken or to convey the information to the wider enforcement and food business community, the FDA will issue a national Food Alert. The Food Alert notification will be issued to all enforcement agencies. The alert will also be sent to public health representatives, food business representatives, and other interested groups and organisations who have requested to be on the circulation list. While notifications will also be sent by letters where requested, e-mail will be considered as the normal means of communication. As a supplement to the e-mail notification, contacts will also have the option of receiving WhatsApp or SMS text messages issued by the FDA to inform recipients of the issue of an alert. Once issued, all Food Alerts will be placed on the FDA website: www.fdaghana.gov.gh The Food Alert will be in a standard form, identified with a unique, sequential number relating to the year of issue and signed by the CEO FDA (see example in Appendix 4). Food Alerts will be issued in one of two categories: Category I (For Action) – Will be used where there is an identified risk to consumers and action is required to be taken. Ensuring the removal from sale at retail premises of a food identified with a high pathogenic bacterial loading or chemical contamination is an example of the type of alert which would fall in this category. The detail contained in the alert will clearly set out what is known about the food (including batch/production codes, unit sizes, quantities affected date markings, etc), the nature of the hazard and the risk along with what specific action is required. This will enable official agencies and food businesses to act in an appropriate, consistent and co-ordinated manner to control the risk. FDA collaborating agencies will be provided with direction on the level of response and enforcement required and any other action to be carried out (see appendix 5 Guidelines for National Guidelines for The Recall of Food). Category II (For Information) – Will be used for passing on information relating to food safety, but not detailing or requiring any action to be taken. Where a product recall has been initiated by a food producer and there is no further action being required, would be an example of such a notification. Category II Alerts are a means of making. Food and Drugs Authority, Ghana 32 National Food Safety Emergency Response Plan (FoSERP) CHAPTER FIVE 5.0 COMMUNICATIONS AND INFORMATION MANAGEMENT Effective emergency management and incident response activities rely upon flexible communications and information systems that provide uniform understanding across all agencies. Properly planned, established, and used communications processes and systems enable the vertical and horizontal dissemination of information among and between FDA and its collaborating agencies and international agencies; and to the news media, industry, and consumers. 5.1. INTER - AGENCY COORDINATION During the course of any incident for which FoSERP may be necessary, timely communications and information sharing among MDAs is critical to assist FoSERP/OC with gaining and maintaining situational awareness and making decisions. Incident information, such as food safety emergency alerts and status/situation reporting, can aid in developing an agency IAP, serve as the basis for releasing public messages, determine the need for involvement of National/Regional FoSERP/OC. The following are examples of information generated by FoSERP/OC and the technological systems they rely on for use during an incident to build uniform understanding for all collaborating agencies. 5.1.1 Food Safety Emergency Alerts FoSERP/OC may be alerted to a food safety threat or hazard through a variety of means, including from FDA and its collaborating agencies, other government agencies, consumers, industry, media and international agencies. Formal notifications typically occur by phone (primary) to FoSERP/OC with appropriate follow-up by email and/or letter referencing the initial emergency alert. FoSERP/OC records the initial call and subsequently follow-up with the information. Upon receipt, the FoSERP/OC shall notify the FoSERP/MC (see appendix 7) of food safety emergency alerts. For each incident, FoSERP/OC will provide notification about the incident to relevant institutions and departments who may have a response role in that particular incident. 5.1.2 Situation Reporting Standardized incident reporting and documentation procedures ensure that intra-agency and inter-agency-wide situational awareness is maintained and provide emergency personnel with easy access to critical information. Status reports relay information specifically related to the availability or assignment of agency resources. Situational reports (SitReps) offer a snapshot of each tasked organizational component’s emergency operations and contain confirmed information regarding the explicit details of the incident (who, what, when, where, and how). Transmission of this data in a common format, and at predesignated intervals, enables FDA and its collaborating agencies to rapidly share critical intelligence and information between National, Regional and District as well as external partners as appropriate. Food and Drugs Authority, Ghana33 National Food Safety Emergency Response Plan (FoSERP) During an incident, FoSERP/OC and RRT shall maintain regular SitReps via the email, Whatsup, etc. These SitReps highlight significant event information and food safety emergency response activities (e.g., investigations, analyses, public affairs, cooperating agencies, scientific data, legal court matters). ICs and FoSERP/OC are responsible for configuring the (SitRep) process, defining recipients, and reviewing and accepting inputted information. Once field SitReps have been approved/confirmed by district FoSERP/OCs, the report is transmitted to the National FoSERP via the Regional FoSERP who then disseminate to relevant MDAs and post it on the FDA website. This report combines relevant data from field SitReps for dissemination across FDA and is used to provide operational information to other agencies. 5.2. COMMUNICATING AMONG MDAS During emergency response operations, a requirement may exist to conduct secure communications with other government agencies. This situation requires strict adherence to guidelines and regulations for handling, processing, and storing sensitive/classified materials. FDA and its collaborating agencies shall restrict access to sensitive and classified material to ensure its release to only those agency personnel who possess appropriate security clearances and a need-to-know. FoSERP/OC shall maintain contact details of Institutional Food Safety focal points(see appendix 7). 5.3. COMMUNICATING AMONG REGIONS AND DISTRICTS During an incident, both the District FoSERP/OC and other investigating Districts are responsible for establishing communications with responsible MMDAs. Usually, FDA and its collaborating agencies will work through the FoSERP/OC at the district and regional level or through the use of predesignated RRTs. The Public Health Emergency Operation Centre (PHEOC) maintains a rapid communication system to alert officials in governments, major municipalities, and poison control centers and to quickly enlist nationwide assistance for the emergency operations. During an incident, the PHEOC will: 5.4. COMMUNICATING WITH FOREIGN PARTNERS 5.4.1. INFOSAN The International Food Safety Authorities Network (INFOSAN) is a joint FAO/WHO Ensure the appropriate MDAs, such as agriculture and health departments, are notified of significant confirmed incidents within an area or which cross borders, indicating the potential for problem along the food chain. Prepare (or distribute) information requested by MDAs during the emergency response operations and ensure they are fully advised as to what action(s). FoSERP/OC can recommend under the circumstances of the specific incident. Food and Drugs Authority, Ghana 34 National Food Safety Emergency Response Plan (FoSERP) entity which assists Member States in managing food safety risks and in ensuring rapid sharing of information during food safety emergencies. The aim is to stop the spread of contaminated food from one State Party to another. INFOSAN also facilitates the sharing of experiences and tested solutions at the national level and between State Parties in order to optimize future interventions to protect the health of consumers. National authorities of 188 Member States are part of this network. The INFOSAN Emergency Contact Point (ECP) is responsible for reporting urgent food safety events and responding to verification requests from the INFOSAN Secretariat. INFOSAN Focal Points (FP) work with the INFOSAN ECP on food safety events, share information, and disseminate information from INFOSAN as appropriate. The INFOSAN ECP for Ghana is located at the Food and Drugs Authority (see Appendix 2 outlines the roles and responsibilities of ECP and FPs within INFOSAN). 5.4.2. IHR The International Health Regulations (IHR 2005) are an international legal instrument that is binding on 196 State Parties globally including all member States of the WHO. The purpose and scope of these Regulations are 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. Pursuant to the IHR, each State Party must establish or designate a National IHR Focal Point (NFP). The NFP is the national centre or office which is accessible at all times for IHR related communications with WHO, IHR Contact Point and all relevant sectors of the State Party’s administration. The IHR NFP for Ghana is located at Disease Surveillance Department, Ghana Health Service. 5.4.3. REPORTING MECHANISMS AND REQUIREMENTS i. Verification requests When necessary, the National FoSERP/OC may request the regional/district FoSERP/OC to validate or verify information regarding an event. When this occurs, the request needs to be provided within 24-hours by the fastest communication channel possible such as; e-mail, phone call, tele conference, text messages, etc. ii. Reporting of issues to international partners The mechanism by which Ghana reports an event is dependent upon its nature. Figure 6 provides a flow diagram to assist in determining whether reporting should occur via the INFOSAN and/or IHR network. iii. Reports to INFOSAN The INFOSAN ECP at FDA will notify the INFOSAN Secretariat at WHO of significant food safety events and certain food product recalls as outlined in Appendix 5. In all instances, when information shared with INFOSAN contains information on actual human illness, officials from the Ghana Health Service will be copied on the Food and Drugs Authority, Ghana35 National Food Safety Emergency Response Plan (FoSERP) notification. The INFOSAN Secretariat may subsequently determine that an alert need to be posted on both the INFOSAN Community Website and/or the WHO Event Information Site for IHR NFPs. In such situations, the INFOSAN Secretariat will share the draft alert with the ECP in Ghana, who will consult with other FPs in GRA (customs division), veterinary services department, GSA, Ministry of Defense (GAFMS), GHS (DSD, DCD) if the alert contains details on actual human illness. The INFOSAN Secretariat shall not post the alert until Ghana, has provided its approval; therefore, there is typically no need for dual reporting. If there is additional public health information that should be reported (and not contained in the INFOSAN alert), this should be reported to WHO separately through one of the IHR communication mechanisms (notification, consultation, other reports) described below. A. National Food Recall in Ghana NoYes Does the issue meet the National Food Safety Authority’s criteria (Appendix 3) for reporting to INFOSAN Secretariat? Is there human illness in Ghana? Emergency Contact Point copies INFOSAN FPs and IHR NFP on INFOSAN notification (Appendix 4) Emergency Contact Point sends notification to INFOSAN Secretariat INFOSAN Secretariat determines if an Alert to be posted on INFOSAN Community Website and/or WHO Event Infomation Site for IHR National Focal Points and shares the draft alert with Ghana for review before posting. Not necessary to report INFOSAN Secretariat Yes No B. Human foodborne disease cases in Ghana NoYes Is the event a potentiall PHEIC, a case of Hepatitis A or Cholera in a non-citizen diagnosed in Ghana, or illness in citizens acquired while travelling abroad? Is there imported or exported food (into/out of Ghana) involved? Has INFOSAN already been notified or has an INFOSAN Alert already been posted? 7 FPs informs FDA and/or allows for review draft IHR notification (if needed) Is there additional public health information (not contained in the notification or allert) that still needs to be reported? FDA notifies IHR NFP as per usual national process IHR-NFP reports to WHO IHR Contact Point (notification, consultation, or other reports) and/or engages in direct communication with other IHR NFPs, as appropriate. Not necessary to report to IHR NFP Yes No Yes Yes No No further action No Figure 7: Decision trees for determining whether to report via INFOSAN and/or IHR Food and Drugs Authority, Ghana 36 National Food Safety Emergency Response Plan (FoSERP) Communication with WHO (under the IHR) There are numerous types of reports which are required to be sent to WHO by the IHR NFP under the IHR (2005); however, for the purposes of this protocol, the following types of notification and information sharing are most likely to occur: i. ii. iii. iv. v. vi. In Ghana, all events of potential international public health concern have to be assessed for potential notification within 48 hours of the State Party becoming aware of it at the national level. Under Article 6 of the IHR, notifications must occur within 24 hours of assessment by Ghana using the decision instrument provided in Annex 2 of the Regulations. Appendix 6 contains the Annex 2 decision instrument and examples for its application. Information shared with the WHO may include public health information such as case definitions, laboratory results, source and type of risk, numbers of cases and deaths, conditions affecting the spread of the disease and the health measures employed in response to the event and when necessary, the difficulties faced, and support needed in responding to the potential public health emergency of international concern. Please refer to Appendix 6 for a template for the notification of events. For unusual or unexpected public health events within Ghana, irrespective of origin or source, as defined under Article 7 of the IHR, the relevant health programme area should consider keeping WHO informed to allow for rapid assessment and early warning of an event that has the potential to become an international concern. Furthermore, through the NFP, Ghana must, as far as is practicable, inform WHO within 24 hours of receipt of evidence of public health risks identified outside their territories that may cause international disease to spread, as manifested by exported or imported human cases, vectors that may carry infection or contamination, or contaminated goods (Article 9.2). In the case of events occurring within its territory not requiring notification as provided in Article 6, Ghana may keep WHO advised thereof and consult with WHO on appropriate health measures (Article 8 Consultation). In addition to notifications under Article 6, consultations under Article 8, and information sharing under Articles 7 and 9, the NFP may also send bilateral information sharing notices to other State Parties under Article 44 of the Regulations. Under the Article 10 of the IHR, WHO may request verification from Ghana of reports from sources other than official notifications or consultations of events which may constitute a PHEIC allegedly occurring in the State’s territory. [For example, if WHO received a report from Nigeria or a media report of a significant public health event in Ghana, WHO could request further information, or a verification of the event, from Ghana.] Ghana, via the NFP, is required to verify and provide: a. b. c. Within 24 hours, an initial reply to, or acknowledgement of, the request from WHO Within 24 hours, available public health information on the status of events referred to in WHO’s request; and Information to WHO in the context of an assessment under Article 6, including relevant information as described in that Article. Food and Drugs Authority, Ghana37 National Food Safety Emergency Response Plan (FoSERP) In all instances, when information shared with the IHR NFP contains information on food safety investigation, the INFOSAN ECP at the FDA will be made aware and given the opportunity to comment and correct, if necessary. Coordination To streamline the reporting process among national stakeholders, the INFOSAN ECP at the FDA and the INFOSAN FP at the 7 FPs will liaise with the INFOSAN FP at the Ghana Health Service for matters related to food safety, and in turn, the INFOSAN FP at the Ghana Health Service will be responsible for liaising with the national IHR NFP by contacting the 24/7 single window account at the Department. Accuracy Control Unless otherwise stated in existing procedures or guidelines, any response to verification requests, reports to the INFOSAN Secretariat, and other reports to WHO will require accuracy check from INFOSAN ECP, FDA. Figure 8: Institution Representation of FoSERP/MC and Their Communication Lines 5.5. PUBLIC ANNOUCEMENT Public announcement consists of the processes, procedures, and systems to communicate timely, accurate, and accessible public health and medical information to the media and directly to FDA stakeholders (both directly and indirectly affected). Information must be coordinated and integrated across FDA and its collaborating agencies as well as with industry partners to protect consumer well-being and decrease the risk of illness, injury, disease, or death. Well-developed communications 40 comment and correct, if necessary. Coordination To streamline the reporting process among national stakeholders, the INFOSAN ECP at the FDA and the INFOSAN FP at the 7 FPs will liaise with the INFOSAN FP at the Ghana Health Service for matters related to food safety, and in turn, the INFOSAN FP at the Ghana Health Service will be responsible for liaising with the national IHR NFP by contacting the 24/7 single window account at the Department. Accuracy Control Unless otherwise stated in existing procedures or guidelines, any response to verification requests, reports to the INFOSAN Secretariat, and other reports to WHO will require accuracy check from INFOSAN ECP, FDA. Figure 8: Institution Representation of FoSERP/MC and Their Communication Lines FoSERP/OC INFOSAN Secretariat RASFF Secretariat IHR Secretariat WTO-SPS Secretariat OIE Secretariat 38 National Food Safety Emergency Response Plan (FoSERP) plans and strategies executed by responsible FoSERP/OC staff help to ensure that messages, alerts and warnings, educational materials, and situational updates are developed and distributed to numerous audiences in a timely, consistent manner. FoSERP/OC is responsible for coordinating the release of information to the public during food safety emergency. This could be done through issuing press releases, press conference and other public statements; respond to media requests; and arrange and support media interviews. 5.6. PARLIAMENT When necessary, the legislative arm responsible for health will be briefed by the respective Sector Minister. Figure 9: Flowchart of Information Flow/ Reporting Mechanism 2. Signal Evaluation and Prioritization 4. Communicating with Foreign Partners e.g., INFOAN, IHR actions e.g risk management options 1. Signal Detection and Identification e.g., events, health effects Surveillance systems, community volunteers, Hazard identification, risk assessment etc. General public (consumers), media scanning Forms of Alert – All channels of communication e.g., phone calls whatsapp, e-mail etc. 1. Food-related, public health impact checks etc 2. Hazard identification, risk assessment etc. See Appendix 1 and Fig. 4 3. Follow-up actions eg. IAP Reporting to foreign partners See Appendices 2, 3 and 6 Institutions constituting the FoSERP/MC See Appendix 7 Food and Drugs Authority, Ghana39 National Food Safety Emergency Response Plan (FoSERP) CHAPTER SIX 6.1. MONITORING AND EVALUATION (M&E) Monitoring and Evaluation of the FoSERP will be the responsibility of the Ministry of Health, in collaboration with the Food and Drugs. As part of the process an effective M&E system will be built into the strategic framework from the onset. The system will monitor the implementation of the plan and performance against a set of pre-determined indicators at all levels. All collaborating institutions will be expected to setup a monitoring and evaluation system for FoSERP in accordance with system prescribed by the FoSERP/MC. The system will be replicated across the regions and districts where possible to ensure synchronisation and harmonisation. Implementing agencies shall be required to submit yearly reports to the FoSERP/MC. There shall be an annual stimulation exercises which shall be used to evaluate the FoSERP processes, and this shall be published periodically. 6.2. REVIEW OF THE FoSERP This may be done periodically or within a certain reasonable time-period that takes into consideration, the nature, scope and time frame of the FoSERP. Notification received on incidents Implement emergency response plan Yes Yes Yes Yes Yes Yes No No No No No No Does it involve or implicate a food item? Does it have the potential to impact the food chain negatively? Is the incident usual or unexpected? Does it involve two or more people falling sick? Refer to appropriate authority Monitor incident and/or implement appropriate regulatory actions Does the incident raise security concern or is there potential for escalation to intensify? Is the public health impact of the incident serious? APPENDIX 1: DECISION INSTRUMENT FOR THE ASSESSMENT OF FOOD SAFETY INCIDENTS THAT MAY CONSTITUTE FOOD SAFETY EMERGENCY Food and Drugs Authority, Ghana 40 National Food Safety Emergency Response Plan (FoSERP) APPENDIX 2: FLOWCHART OF HANDLING PROCEDURES FOR FOODBORNE DISEASE OUTBREAKS Detection of outbreak Presumption/determination of etiologic food Examination of distribution systems Presumption/determination of source of contamination Implementation of control measures Presumption or determination of pathogenic agents and other hazards Inquiry of food eaten (whether or not common food was eaten) Symtoms and dates of onset Medical examinations Examination (food, water and food contact surfaces) Examination of raw food materials and sources Facility investigation (GMP/GHP) Detection of outbreak Detection of outbreak Assembling of RRT Formation of survey groups and assigning Food and Drugs Authority, Ghana41 National Food Safety Emergency Response Plan (FoSERP) APPENDIX 3 OVERVIEW OF INFOSAN ROLES AND RESPONSIBILITIES Food and Drugs Authority, Ghana 42 National Food Safety Emergency Response Plan (FoSERP) ALERT NOTIFICATION 2001.028 Category I: For Action Antibiotic residues in Fafa’s Chicken Nuggets Notifying Country Germany Country of Origin Italy Product Fafa’s Chicken Nuggets Product Description Frozen chicken nuggets, 45 x 500mg packs Manufacturer Good4U Food Supplements, Cathedral St, Rome Minimum Durability Date End 11/2004 Lot No. 345245-04B Importer Marcel & Detroit, D-90675, Awoshie, Ghana Message The Food and Drugs Authority advises that the product Fafa’s Chicken Nuggets be withdrawn from the Ghanaian market. The product was found to contain the antibiotic residues Chloramphenicol and Streptomycin. These antibiotics are used as human medicine. They can be introduced in chicken food during the rearing of chickens but produce a serious health risk when they are introduced into processed chicken. These antibiotics are not permitted in Chicken nuggets so as a precautionary measure the affected lots should be withdrawn. Consignments of the implicated products have been dispatched to Ireland from Ghana, some of which have already been supplied to the food industry. No other products from these manufacturers or importers are affected in any way. Only the products detailed above are the subject of the notice. Nature of Danger Presence of the antibiotic residues Chloramphenicol and Streptomycin which are not permitted in Chicken nuggets. Action Requested Retailers/ Wholesalers are requested to remove these products from shelves EHOs are requested during the course of routine inspections to ensure that these products are removed from sale. Delease A.A Darko Chief Executive Officer 1st April, 2001 TELEPHONE: +233 302233200, 235100; WhatApp: 233 206973065 EMAIL: fda@fda.gov.gh APPENDIX 4: EXAMPLE OF ALERT NOTIFICATION Food and Drugs Authority, Ghana43 National Food Safety Emergency Response Plan (FoSERP) APPENDIX 5: NATIONAL GUIDELINES FOR THE RECALL OF FOOD Document No. :FDA/FID/FMS/GL-REP/2020/01 Date of Adoption : Effective Date : Version No. : 01 DRAFT GUIDELINE FOR RECALL OF FOOD PRODUCTS 49 70 TABLE OF CONTENT 71 72 1.0 INTRODUCTION 3 73 2.0 GLOSSARY 4 74 3.0 REQUIREMENTS 6 75 3.1 RESPONSIBILITY FOR PRODUCT RECALL 6 76 3.1.1 MANDATORY PRODUCT RECALL 6 77 3.1.2 VOLUNTARY PRODUCT RECALL 6 78 3.2 RECALL TRIGGER 6 79 3.2.1 VOLUNTARY RECALL 6 80 3.2.2 MANDATORY RECALL 7 81 3.3 RECALL AND ALERT CLASSIFICATION 7 82 3.4 LEVELS OF RECALL 8 83 3.5 TIMELINES FOR EFFECTIVE ALERTS AND RECALL 8 84 3.6 PROCEDURE FOR ALERT AND RECALL 8 85 3.7 RECALL COMMUNICATION 9 86 3.7.1 GENERAL 9 87 3.7.2 IMPLEMENTATION 9 88 3.7.3 PUBLIC ALERTS AND NOTIFICATION 9 89 3.8 EFFECTIVENESS CHECKS 10 90 3.9 POST RECALL NOTIFICATION TO THE FDA 10 91 3.10 SAFE DISPOSAL OF RECALLED FOOD PRODUCTS 10 92 3.11 TERMINATION OF A PRODUCT RECALL ACTIVITY 11 93 4.0 COMMUNICATION WITH THE AUTHORITY 11 94 5.0 TIMELINES 11 95 6.0 SANCTIONS 11 96 7.0 PENALTIES 11 97 98 99 100 101 102 103 104 105 Food and Drugs Authority, Ghana 44 National Food Safety Emergency Response Plan (FoSERP) Food and Drugs Authority, Ghana45 National Food Safety Emergency Response Plan (FoSERP) In exercise of the powers conferred on the Food and Drugs Authority (FDA) by Part Seven, Section 148 of the Public Health Act, 2012, Act 851, these guidelines apply to all manufacturers, importers, exporters, wholesalers and retail outlets or any entity involved in the distribution and/or trading of food products in Ghana. The purpose of these guidelines is to ensure that food products distributed in Ghana, whether offered for sale or as a prize, reward or donation in compliance with food safety requirements and does not pose a risk to public health and safety. These guidelines also provide a comprehensive procedure for complying with good practices in the food distribution chain in compliance with Part Seven of the Public Health Act, 2012, Act 851. This guideline is hereby promulgated for information, guidance and strict compliance by all concerned to prevent public events and emergencies. 1.0 INTRODUCTION Food and Drugs Authority, Ghana 46 National Food Safety Emergency Response Plan (FoSERP) 2.0 GLOSSARY For the purpose of these guidelines the following definitions shall apply: Contaminants: means any substance not intentionally added to food, which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry, and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination. The term does not include insect fragments, rodents’ hairs, any other extraneous matter. Contamination: The introduction or occurrence of a contaminant in food or food environment. Food: includes water, a food product, a live animal or a live plant, and (a) a substance or a thing of a kind used, capable of being used or represented as being for use, for human or animal consumption whether it is live, raw, prepared or partly prepared, (b) a substance or a thing of a kind used, capable of being used or represented as being for use, as an ingredient or additive in a substance or a thing referred to in paragraph (a), (c) a substance used in preparing a substance or a thing referred to in paragraph (a), (d) chewing gum or an ingredient or additive in chewing gum or a substance used in preparing chewing gum, and (e) a substance or a thing declared by the Minister to be a food under section 146 (3); Food Safety: Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use. Public Health Events: Exposure to toxins, poisoning and any other events of public health importance. Public Health Emergency: Any event that immediately threatens life and health, or has already caused a loss of life, health detriments etc or has a high probability of escalating to cause immediate danger to life and/or health. Product Recall: Removal of a product from the food distribution chain to prevent further sale, distribution or use, for correction, of a marketed product that does not meet regulatory requirements as specified in the Public Health Act and/or any relevant guidelines promulgated by the FDA. Voluntary Product Recall: When a firm requests a product recall as a result of food safety concerns, product defects or non-compliance to regulatory requirements. Food and Drugs Authority, Ghana47 National Food Safety Emergency Response Plan (FoSERP) Mandatory, Statutory or Non-Voluntary Recall: When the FDA requests or orders a product recall as a result of the discovery of the existence of non-compliance(s) to regulatory requirements. Recalling Firm: The firm that initiates a recall. It is usually the firm that has primary responsibility for the manufacture or importation and marketing of the product to be recalled. Product Withdrawal: Removal of a product from the food distribution chain to prevent further sale, distribution or use, for correction, of a marketed product that does not violate legislation administered by the FDA. Product withdrawal is not considered to be a product recall. Stock Recovery: Removal or correction of a product that has not been marketed or that has not left the direct control of the firm (manufacturer/importer). It is not considered to be a recall. Recall Plan: means a planned specific course of action to be taken in conducting a specific recall, which addresses itself to matters such as the depth of recall, need for public warnings, and extent or effectiveness checks for the recall. Correction: Rework, modification, or re-labelling of a product. Hazard: A biological, chemical or physical agent, in, or condition of, food with the potential to cause an adverse health effect. Labelling: includes any written, printed or graphic matter that is present on the label, accompanies the food, or is displayed near the food, including that for the purpose of promoting its sale or disposal. Premises: includes land, buildings, structures, basements, and vessels and in relation to a building, includes a part of a building and the cartilage, forecourt, yard or place of storage used in connection with the building or part of the building and in relation to a vessel, includes a ship, boat, an aircraft, a carriage or receptacle of any kind whether open or closed. Batch/Lot: A definite quantity of ingredients or a food that is intended to have uniform character and quality, within specified limits, is produced under the same conditions, and is assigned a unique reference identification number by the food business operator. Retail: retail is the sale of goods and services (including food products) from businesses to an end user (customer or consumers). Food and Drugs Authority, Ghana 48 National Food Safety Emergency Response Plan (FoSERP) Non-conforming food product: Any food product which does not meet the defined safety and/or quality parameters as prescribed. Food and Drugs Authority, Ghana49 National Food Safety Emergency Response Plan (FoSERP) 3.1.1 Mandatory Product Recall 3.0 REQUIREMENTS 3.1 RESPONSIBILITY FOR PRODUCT RECALL The FDA shall be responsible for requesting/ordering a product recall when the registration of a product is cancelled for safety reasons, or when the product does not meet regulatory requirements. The FDA shall monitor the effectiveness of the recalling firm’s actions and provide scientific, technical and operational advice where necessary. 1. 2. 3.2.1 Voluntary Recall Voluntary recall of food products may be triggered by any incident which has the potential to adversely affect the safety and quality of the product or a batch(lot) of the product such as: 1. 3.1.2 Voluntary Product Recall The Recalling Firm shall be responsible for the initiation, conduct and monitoring of Voluntary Product Recalls. Prior notice shall be given to the FDA regarding the intention to conduct a voluntary product recall. The Recalling Firm shall contact all companies to whom the recall products have been distributed to. The Recalling Firm shall ensure the physical removal of the products from the market to the level required. The FDA may take appropriate regulatory actions regarding a voluntary product recall if the actions of the recalling firm is determined to be inadequate in order to ensure an effective recall process. 1. 2. 3. 4. 5. Batch(lot) found in trade or in the possession of distributors and which does not comply with regulatory standards or specifications. Batch(lot) which are found to be non-conforming during investigation of consumer complaint(s). If any unusual observation is noted during visual inspection of reference samples which indicate an impact on safety and/or quality of the product or batch(lot) of the product. When data from market surveillance activities indicates that there is a food safety risk(s) associated with the consumption of the product or batch (lot) of the product. Product or batch(lot) of product identified to be in violation of regulatory requirements such as adulteration, misbranding, illegal substitution of ingredient(s), non-declaration of known allergens. Products for which the product registration (market a. b. c. d. e. f. 3.2 RECALL TIGGGER A product recall shall be triggered with the discovery of the existence of a non-conforming batch or lot of a food product. Food and Drugs Authority, Ghana 50 National Food Safety Emergency Response Plan (FoSERP) 3.2.2 Mandatory Recall Mandatory recall of products or batch(s) of products from the market by the FDA may be triggered by any of the following: 1. Product or batch(lot) of product identified to be in violation of regulatory requirements such as adulteration, misbranding, illegal substitution of ingredient(s), non-declaration of known allergens. Products for which the product registration (market authorization) have been withdrawn/cancelled. Labelling and/or promotional materials which are in violation of FDA regulations. Batch(lot) which are found to be non-conforming during investigation of consumer complaint(s). When data from market surveillance activities indicates that there is a food safety risk(s) associated with the consumption of the product or batch (lot) of the product. a. b. c. d. e. 3.3.1 Category I Recall involves food products or batches(lots) of products with food safety and/or quality non-compliance(s) which has the potential to adversely affect public health. This may include but not limited to chemical and biological contamination of the implicated product. 3.3.2 Category I Alert requires action This applies where there is an identified food safety hazard and/or risk to consumers and action is required to safe guard public health. This should ensure the removal of the product or batch(lot) of the product from the food distribution chain. The details contained in the alert or notification will clearly set out what is known about the food (including batch/production codes, size of containers, quantities affected, durability dates, etc), the nature of the hazard and the risk as well as the specific action required. 1. 2. 3. This applies when passing on information relating to a food product recall which does not require additional action to be 1. 3.3.3 Category II Recall involves non-compliant products or batches (lots) of products which is unlikely to cause adverse health effects, but that violates FDA labelling or manufacturing requirements. 3.3.4 Category II Alert is for information purposes. 3.3 RECALL AND ALERT CLASSIFICATION authorization) have been withdrawn/cancelled. Labelling and/or promotional materials which are in violation of FDA regulations. g. Food and Drugs Authority, Ghana51 National Food Safety Emergency Response Plan (FoSERP) A recalling firm shall inform the FDA about the discovery of a food safety concern, product defect or any other non-compliance to regulatory requirements with food safety and adverse public health effects within 24 hours of the discovery. All relevant institutions including distributors shall also be alerted with 24 hours to stop further sale of the implicated food product. Per good practices, the existing Recall Procedures in the Recalling Firm shall be activated within 24 hours. The recall Procedures shall be followed through and efforts put in place to ensure the recall is completed in not more than ten (10) days. 1. 2. 3. 4. Consumers or end-users: The recall plan and activity are designed and implemented to reach final consumers of the implicated food product or batch(lot) of the product. Retailers: The recall plan and activity are designed and implemented to reach all retailers of the implicated food product or batch(lot) of the product. Wholesalers: The recall plan and activity are designed and implemented to reach all wholesalers of the implicated food product or batch(lot) of the product. a. b. c. The communication should be done using the fastest mode of communication available to the recalling firm. The communication should state the severity of the non-compliance and the proposed action to be taken. a. b. 3.4 LEVELS OF RECALL The level (or depth) of recall of a product/batch shall be determined based on recall classification and level to which distribution has taken place. The three identified levels of levels of recall shall be as follows: 1. 2. Category II Alerts will ensure the FDA and/or food businesses in the food supply chain are aware of food safety and quality issues where there may be, for example, responses to enquiries from the public. 2. taken such as where a product recall has been initiated by a food producer and there is no further action required. 3.5 TIMELINES FOR EFFECTIVE ALERT AND RECALL The FDA may be alerted to a threat, hazard, or other significant event through any available medium, including but not limited to industry, consumers, news media, internal FDA organizational components and international agencies (e.g., INFOSAN). Within 24 hours of taking the decision to conduct a food product, a communication shall be sent to all relevant parties in the food supply chain as stated in the recalling firm’s recall plan. 1. 2. PROCEDURE FOR ALERT AND RECALL Food and Drugs Authority, Ghana 52 National Food Safety Emergency Response Plan (FoSERP) Name of product The batch(lot) number of the product Reason for the recall Suggested action to be taken and its urgency Provide specific instructions on what should be done with the recalled product. a. b. c. d. e. Information that the product in question is subject to a recall. Information that furthers distribution or use of any remaining product should cease immediately. Instructions regarding what is to be done with the recalled product. a. b. c. This should be via a far-reaching media outlet with nation-wide coverage or distribution. a. 3.6.1 General 3.6.2 Implementation 3.6.3 Public Alerts and Notification A recalling firm is responsible for promptly notifying its affected distribution outlets about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard associated with the use of the product and the strategy developed for the recall. Recall communication should convey: The recall procedure should be implemented according to the recall plan of the recalling firm using the fastest means of communication available to the recalling firm. 1. 2. 3. In a situation where the product or batch (lot) of product has been widely distributed, a public notification shall be issued If a company does not issue public notification of a recall, the FDA may do so if the Authority determines it is necessary to protect consumers and public health. 1. 2. 3.6 RECALL COMMUNICATION The recalling firm shall provide information on where the product or batch (lot) of product was distributed to immediately after the decision to recall has been taken to the FDA. It is the responsibility of the recalling firm to immediately after discovering the non-compliance officially notify distributors and/or retailers to suspend sale and/or further distribution of the implicated product. Details of notification shall include but not limited to 3. 4. Follow-up communications should be sent to those who fail to respond to the initial recall communication. Records of the recall notice, available stock and returned stock from various outlets shall be maintained by the recalling firm and shall be made available for verification by FDA regulatory officers. 5. 6. Food and Drugs Authority, Ghana53 National Food Safety Emergency Response Plan (FoSERP) The percentage is to be determined on a case-by-case basis and should be acceptable to the FDA. a. The percentage is to be determined on a case-by-case basis and should be acceptable to the FDA. a. Level A - 100 percent of the total number of distribution outlets contacted and have responded appropriately Level B - Greater than 10% but less than 100% of total number of distribution outlets contacted and have responded appropriately. 1. 2. Name of product, Batch or lot number(s), Manufacturing and Expiry Dates, manufacturing company and address and any other means of identification. The total quantity of the implicated product or batch (lot) of the product imported or manufactured. The total quantity of the implicated product or batch (lot) of the product in possession of the company at the time of the recall. The total quantity of the implicated product or batch (lot) of the product that had been distributed at the time of the recall The distribution record of the implicated product or batch(lot) of the product. The reason for initiating the recall – nature of defect. Report on the recall process which should include information on investigation conducted to identify root cause of the non-compliance and relevant corrective actions as well as the safe disposal of the recalled products. 1. 2. 3. 4. 5. 6. 7. Level C - 10 percent or less of the total number of distribution outlets contacted and have responded appropriately. 3. Level D - No effectiveness checks detected.4. An effectiveness check shall be conducted by the recalling firm to verify that all affected distribution outlets identified have received notification about the recall and have taken appropriate actions to recall the implicated products from the food distribution chain. The level of effectiveness is categorised as follows: The FDA may carry out its own effectiveness checks as part of monitoring the recalling firm's performance. If a recall is determined to be ineffective, FDA will request the company to take additional actions as appropriate. 3.7 EFFECTIVENESS CHECKS The recalling firm shall notify the FDA in writing with the following information after the recall activity. 3.8 POST RECALL NOTIFICATION TO THE FDA Where applicable, as in the case of a Category I Recall, the disposal of recalled food products shall be in compliance with the FDA’s Guideline for the Safe Disposal of unwholesome food products (FDA/FID/GL-DFP/2013/04). 3.9 SAFE DISPOSAL OF RECALLED FOOD PRODUCTS Food and Drugs Authority, Ghana 54 National Food Safety Emergency Response Plan (FoSERP) This should be done through written correspondence to the FDA. 3.10 TERMINATION OF A PRODUCT RECALL ACTIVITY TIMELINES The Authority shall within a maximum period of five (5) working days, respond to all communications. SANCTIONS Any person who contravenes or fails to comply with any of the requirements of these guidelines commits an offence and shall be liable to an administrative charge per Fees and Charges (Miscellaneous Provisions) Instrument, 2019. L. I. 2386. PENALTIES Where non-adherence to this guideline or Section 97 of the Public Health Act, 2012, Act 851 results in exposure of consumers to a food safety risks, the FDA will impose an Administrative Charge in accordance with Section 148, Sub-Section 4 & 5 of the Public Health Act, 2012, Act 851. All applications to undertake a product recall or to implement any part of this guidelines shall be addressed to: The Chief Executive Officer Food and Drugs Authority P. O. Box CT 2783 Cantonments-Accra 4.0 COMMUNICATION WITH THE AUTHORITY 5.0 6.0 7.0 60 Food and Drugs Authority, Ghana55 National Food Safety Emergency Response Plan (FoSERP) APPENDIX 6: IHR DECISION INSTRUMENT 61 APPENDIX 7. INSTITUTIONS CONSTITUTING THE FoSERP/MC AND THEIR DETAIL No. REPRESENTATIVE CONTACT MINISTRY 1. INFOSAN Emergency Contact point Food Safety Management, Food and Drugs Authority Ministry of Health 2. OIE Emergency contact point Veterinary Services Directorate Ministry of Food and Agriculture 3. IPPC Emergency Contact point Plant Protection and Regulatory Service Directorate Ministry of Food and Agriculture 4. RASFF Contact point Ghana Standards Authority Ministry of Trade and Industry 5. IHR Focal point Disease Surveillance Department, Ghana Health Services Ministry of Health 6. National Security Focal point National Security Secretariat Ministry of Interior 7. Fisheries Contact point Fisheries Commission Ministry of Fisheries and Aquaculture Development 8. GRA contact point Customs Division Ministry of Finance 9. Ghana Armed Forces Medical Services Contact Point Public Health Directorate, 37 Military Hospital Ministry of Defence The services of other agencies will be sought as and when necessary. Food and Drugs Authority, Ghana 56 National Food Safety Emergency Response Plan (FoSERP) APPENDIX 7: INSTITUTIONS CONSTITUTING THE FOSERP/MC AND THEIR DETAIL Food and Drugs Authority, Ghana57 National Food Safety Emergency Response Plan (FoSERP) Note