|Agenda Item 5.2||GF 02/11|
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Prepared by the United States of America)
A primary challenge in the 21st Century is to minimize food safety risk to consumers as the scientific complexity of food grows, and as trade, regulation, new health threats, and consumption patterns continue to change, particularly with respect to the global food supply. The World Health Organization (WHO) reports that surveillance of food borne diseases is becoming an increasingly high priority in the public health agenda in many countries. Such surveillance helps estimate the burden of food borne diseases, assess its relative impact on health and economics, evaluate disease prevention and control programmes, and allows for rapid detection of and response to outbreaks. It is also a major source of information for conducting risk assessment, and more broadly for risk management and communication. Food borne disease surveillance should be integrated with food monitoring data and data from food animals along the entire feed-food chain. Integrating such data would result in robust surveillance information and allow appropriate priority setting and public health interventions. Intersectoral, inter-institutional, and international collaboration are of paramount importance. National surveillance is of varying intensity depending on the country and region on the globe. Additionally, methods used are not necessarily uniform, making data interpretation difficult. Organizations such as the WHO, the World Organization for Animal Health (OIE), and the Food and Agriculture Organization of the United Nations (FAO), are working to improve international surveillance.
With respect to the United States, the U.S. Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (HHS/CDC), in close collaboration with State and Territorial Departments of Health, are responsible for conducting human disease surveillance. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), as well as the HHS’ Food and Drug Administration (FDA), closely monitor this disease surveillance through a variety of human and technological liaison activities described below. FSIS and HHS/FDA react to episodes of food borne disease based on epidemiological information from HHS/CDC or other state and local health authorities linking illnesses to food products. However, both FSIS and HHS/FDA would benefit from better coordination, both nationally and internationally, linking what we see in terms of surveillance with what we observe with foods.
HHS/CDC maintains routine national surveillance for individual cases of food borne infections that depend on regular reporting from state public health departments. These nationally notifiable disease reporting systems collect limited standard information, help track trends in those infections, and alert local, state and national health authorities to potential outbreaks. Serotyping clinical isolates of Salmonella at state public health laboratories is a critical part of this surveillance. In addition, HHS/CDC also maintains a reporting system for food borne outbreaks that are investigated and reported by local and state health departments. This is a web-based reporting system called the Electronic Food borne Outbreak Reporting System (EFORS). EFORS collects standardized information on more than 1200 reports of outbreaks each year.
HHS/CDC also conducts active surveillance for food borne disease through a collaborative active surveillance network called FoodNet. The Food borne Diseases Active Surveillance Network (FoodNet) is the principal food borne disease component of HHS/CDC's Emerging Infections Programme (EIP). FoodNet is a collaborative project of the HHS/CDC, 10 EIP sites (California, Colorado, Connecticut, Georgia, New York, Maryland, Minnesota, Oregon, Tennessee and New Mexico), USDA, and HHS/FDA. The project consists of active surveillance of food borne diseases and related epidemiologic studies designed to help public health officials better understand the epidemiology of food borne diseases in the United States. Food borne diseases include infections caused by bacteria such as Salmonella, Shigella, Campylobacter, Escherichia coli O157:H7, Listeria monocytogenes, Yersinia enterocolitica, and Vibrio, and parasites such as Cryptosporidium and Cyclospora. In 1995, FoodNet surveillance began in five locations: California, Connecticut, Georgia, Minnesota, and Oregon. Each year, the surveillance area, or catchment, has expanded, with the inclusion of additional counties or additional sites (New York and Maryland in 1998, Tennessee in 2000, Colorado in 2001 and New Mexico in 2004). The total population of the 2003 bacterial catchment is 37.6 million persons, or 13.8% of the United States population. FoodNet provides a network for responding to new and emerging food borne diseases of national importance, monitoring the burden of food borne diseases, and identifying the sources of specific food borne diseases. FoodNet provides accurate and detailed surveillance information about those infections for which surveillance is variable or non-existent from state to state. FSIS and FDA’s Center for Food Safety and Applied Nutrition (CFSAN) also participate in the FoodNet surveillance activities. For more information see www.cdc.gov/foodnet.
PulseNet, the national molecular subtyping network for food borne disease surveillance, was established in 1996 by HHS/CDC and several state health department laboratories to facilitate subtyping bacterial food borne pathogens for epidemiologic purposes. PulseNet reached full national participation in 2001. Public health laboratories in all 50 states routinely determine the molecular fingerprints of Escherichia coli O157:H7, Listeria monocytogenes, and regularly subtype common serotypes of Salmonella; standard protocols have also been developed for subtyping a growing number of other food borne pathogens. Food regulatory laboratories at HHS/FDA and FSIS also participate, and HHS/CDC maintains the national database of patterns. Rapid electronic comparison of strain patterns in state and national databases provides early detection of clusters of related infections, guiding investigations, and verifying control. PulseNet identifies potential outbreaks that otherwise would have been missed, particularly those that are widely dispersed. Identifying and investigating such outbreaks can identify system problems in food safety, so that they can be corrected. For example, with the regular use of PulseNet, the frequency of detected outbreaks of listeriosis in the United States has increased from one every five years to two per year, focusing attention on critical points of control within the food safety system. For more information see www.cdc.gov/pulsenet.
In collaboration with WHO, the HHS/CDC helped to establish the International Collaboration on Food borne Diseases “Burden of Illness Studies” Network in March 2004, as a means of establishing communications and collaboration among nations developing burden of illness studies, specifically with respect to acute gastrointestinal illness and food borne disease.
Food borne outbreak investigations are a critical part of the food safety system. New and recurrent food borne hazards can be rapidly identified by investigation of food borne outbreaks. Careful investigation of an outbreak, including tracing the food from farm to table and reconstructing the means of contamination, is critical to move the food safety agenda forward when new hazards emerge. Most outbreaks are investigated and controlled by local and state health departments. HHS/CDC routinely consults with the state health departments as they investigate outbreaks, launches emergency field investigations to assist them in large, complex or unusual outbreaks, collaborates with HHS/FDA and USDA/FSIS on the traceback of implicated food items to their origins, and coordinates efforts to improve outbreak detection and investigation methods.
U.S. federal agencies, state/county officials, foreign governments, law enforcement, health professionals, industry, or news media may issue an alert or notification. Alerts/notifications are related to problems with products that may pose a risk to the public. Information is shared within legal constraints, and information received from other organizations is used to improve analysis and respond to problems. U.S. agencies call upon the capabilities of their various stakeholder communities—regulators, public health partners, industry, and consumers—to generate effective solutions to complex food safety challenges. HHS/FDA and USDA rapidly coordinate responses to contain a problem and remove products from commerce to protect the public’s health.
HHS/FDA’s Emergency Operations Center (EOC) tracks food borne outbreaks in the United States. If an HHS/FDA-regulated product is identified in a food borne illness, EOC coordinates agency-wide responses, including sample collection and analysis, interpretation of disease-related data, and trace back of implicated products. HHS/FDA also has various educational efforts with State and local regulatory authorities promoting food borne illness investigations. Well-trained personnel enhance surveillance, and FDA relies strongly on State and local authorities for quality surveillance information. HHS/FDA also has a Trilateral Agreement for product notifications with Canada and Mexico. In addition, HHS/FDA monitors various electronic and media sources, such as ProMed, which may provide signs of emerging issues. EOC conveys proper alerts through various mechanisms to respond effectively to these situations, as needed.
FSIS relies on a cadre of Public Health and Epidemiology Liaison officers located in regionally based offices (Atlanta and Omaha) who maintain active and open communications with State and Territorial health officials, and are USDA/FSIS’ first point of contact for reports of illness that may be associated with meat, poultry or egg products. There is a 24-hour toll-free number for public health partners to call which routes the caller to the appropriate officer. Additionally, USDA/FSIS has a liaison officer assigned to the HHS/CDC, enabling USDA/FSIS to receive the earliest warning on food borne illnesses that may involve regulated products.
HHS/FDA and FSIS officials receive alerts from HHS/CDC’s Epi-X electronic alert system. Epi-X is a web-based communications system operated by HHS/CDC. Distribution of information through the Epi-X network is to promote rapid communications of recent outbreaks and other health events among local, state, and federal health officials. Epi-X carries reports of disease events outside, as well as inside, the United States. This dissemination of international health information promotes further surveillance of these conditions in the United States, as well as follow-up collaborations with foreign authorities dealing with these health events.
On an emergency basis, HHS/FDA maintains after hours phone contact numbers for all 50 States, and shares information through regularly scheduled conference calls with the States and ad-hoc calls. Additionally, HHS/FDA has the S.A.F.E.S (State Advisory FAX/Email system) communication system, which allows HHS/FDA to broadcast FAX and email information to all 50 states on demand. It is regularly used to disseminate information by the Agency. State agencies that may participate in calls or receive information include Departments of Health, Agriculture, Boards of Pharmacy, Environmental Health, Poison Control Centers, Fish and Wildlife, and State Veterinarians.
HHS/FDA’s Office of International Programmes and FSIS’s Office of International Affairs disseminate food safety information to foreign counterpart food regulatory authorities in other countries, as appropriate. For example, for a food product that is recalled because there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death (referred to as Class I), and is exported, notification will be provided to the counterpart authorities.
The HHS Office of Global Health Affairs coordinates the U.S. work on the International Health Regulations (IHRs), which will include a set of internationally reportable diseases, including food borne diseases. This involves a multi-agency effort that includes, not only HHS agencies, but also State, USTR, and USDA agencies. HHS/FDA has actively participated in this endeavor for a number of years by reviewing documents and providing comments as appropriate.. More recently, FSIS and the USDA’s Animal and Plant Health Inspection Service have also participated in the development of the IHRs.
The Electronic Laboratory Exchange Network (eLEXNET) is a seamless, integrated, web-based data exchange system for food testing information that allows multiple agencies engaged in food safety activities to compare, communicate, and coordinate findings of laboratory analyses. eLEXNET is funded by HHS/FDA and supported by USDA and the Department of Defense (DOD). It enables health officials to assess risks and analyze trends, and it provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods. At present, there are 108 laboratories representing 49 states that are part of the eLEXNET systems with 62 laboratories actively submitting data. We are continuing to increase the number of participating laboratories.
The National Antimicrobial Resistance Monitoring System (NARMS) is an example of a well-coordinated surveillance programme among HHS/FDA, HHS/CDC, and USDA. NARMS monitors antibiotic resistance of select food borne pathogens isolated from clinical settings (both human and animal) and the antibiotic resistance of isolates from foods. The system was initiated in 1996 in response to public health concerns associated with the approval of fluoroquinolone products for use in poultry. NARMS monitors changes in susceptibilities to 17 antimicrobial drugs of zoonotic enteric pathogens from human and animal clinical specimens, from healthy farm animals, from carcasses of food-producing animals at slaughter, and from isolates from samples of retail foods. The system includes a veterinary arm, a human arm, and a retail food monitoring arm.
HHS/FDA operates two post-marketing surveillance systems, the FDA Consumer Complaint System and the CFSAN Adverse Event Surveillance System (CAERS). The Consumer Complaint System monitors complaints from consumers and industry related to HHS/FDA-regulated products already in distribution, and can capture if there is a reported illness, injury, or alleged tampering related to the product.
FSIS has a Consumer Complaint Monitoring System (CCMS) managed by nurses who receive and triage each complaint about USDA/FSIS-regulated products, coordinating the investigation of those complaints that allege illness or injury. The CCMS investigations have led to recognition of outbreaks, voluntary recalls of adulterated products, and changes to specifications of school lunch products. This system is currently undergoing an enhancement which will allow early recognition of complaint patterns that may indicate unusual or intentional events.
Finally, FSIS monitors the occurrence of food borne pathogens through a variety of sampling and testing programmes developed as verification of a food-producing establishment’s Hazard Analysis and Critical Control Point/ Pathogen Reduction plan. As such it is also a surveillance system, allowing FSIS to react to the presence of pathogens considered adulterants with the appropriate public health regulatory response, as well as to provide a rough estimate of the prevalence of specific pathogens on particular products.
Timely alerts via current notification processes are needed. Effective exchange of information is difficult when countries do not carry out the same methods and procedures or do not use the same set of standards. Many non-industrialized countries lack the resources to conduct meaningful surveillance, and even the countries that undertake surveillance may be using different methods and have different standards. These countries need trained staff in government, as well as adequately staffed and equipped laboratories and trained health care professionals, to identify and report diseases.
Establishing consistent laboratory methodologies, laboratory training, emergency preparedness training and procedures, database development, further assistance for developing countries, and strengthened communication networks are key strategies to advance the status of international food borne disease surveillance. Identifying and exchanging specific contact information for specific products with other countries and developing agreements to cross-train with pertinent foreign officials would improve international information exchange. Some countries could also provide training, equipment, and technical support to international organizations, as well as to individual countries.
Surveillance of food borne diseases should be given a high priority in the development of a food safety infrastructure. Building capacity for public health laboratories to conduct laboratory-based surveillance and to conduct epidemiologically-based surveillance are important global public health objectives. The needs of developing countries should be particularly considered. There is a need to be proactive in establishing one or more sentinel sites for food borne disease in developing countries. There is also a need to develop and coordinate a global approach to strengthen surveillance at national, regional, and international levels.
Current surveillance is dependent upon physicians and clinical laboratories reporting illness and specific diagnosed infections. Thus, an improvement would be increasing the capacity of laboratories to identify specific pathogens and developing mechanisms to facilitate reporting of specific diseases. The ongoing support of interagency collaboration, international surveillance, and scientific research is crucial in preparing the international community to deal with food borne disease in the global market place.
Food borne disease surveillance within individual countries is important to track and to monitor domestic food borne threats to public health. Existing national/regional systems such as that of the HHS/CDC, the European EnterNet, and that of the European Rapid Alert System for Food and Feed (see below) are examples of systems that may have applicability internationally. Collected information, including active and passive reporting from sub-jurisdictions (e.g., state and local public health officials), forms the basis of such systems and, when communicated to other countries, preferably though an international portal, is critical to global monitoring and surveillance. Within individual countries, the surveillance arm of government must coordinate with the regulatory arm of government to enforce food safety standards. These internal food safety networks support global surveillance, communication, and coordination. The current structure for international/regional food borne disease surveillance includes both formal and informal relationships between and among countries. Formal programmes include Global Salm-Surv (a global network of laboratories and individuals involved in capacity building for surveillance, isolation, identification, and antimicrobial resistance testing of Salmonella) and the European Commission Health and Consumer Protection weekly reports from the Rapid Alert System for Food and Feed (RASFF). One goal of RASFF is to provide individual control authorities with an effective tool for exchanging information on food safety measures. Yet, formal international food borne disease surveillance communication is limited. Much of what is shared has been dependent upon relationships that people at various agencies developed over the years with colleagues in other countries. WHO’s new INFOSAN initiative (see below) should enhance information sharing significantly.
Efforts are emerging to strengthen international food borne disease surveillance. HHS/CDC works with other countries to assist in developing their version of FoodNet, such as OZFoodNet (Australia’s programme). In addition, a meeting (co-chaired by HHS/CDC and WHO) at the last international Conference on Emerging Infectious Diseases focused on the global effort to develop better food borne disease reporting. There is a more general WHO disease surveillance programme called Communicable Disease Surveillance and Response, a data mining software developed by the Canadians. A number of international links can also be found at www.foodsafety.gov or http://omni.ac.uk/browse/mesh/ C0012652L0012652.html. Another international electronic tool for food borne disease information is ProMed, which reports on international health issues multiple times a day. Below are more details on some of the specific international collaborative efforts.
Collaborative efforts undertaken by HHS/CDC to foster international dissemination of food borne infectious diseases information include:
Global Salm-Surv is part of WHO's effort to strengthen the capacities of its Member States in the surveillance and control of major food borne diseases and to contribute to the global effort of containment of antimicrobial resistance in food borne pathogens. Since 2000, institutions and individuals in human health, veterinary, and food-related disciplines have participated in Salm-Surv activities, such as regional trainings for microbiologists and epidemiologists, external quality assurance and reference testing, an electronic discussion group, and a web-based databank containing an annual summary of laboratories. Over the next five years, Global Salm-Surv plans to improve its regional coverage with new training courses in Central Asia, Eastern and Southern Africa, Brazil, and Europe, encourage participation in the External Quality Assurance System and in Focused Regional or National Projects, expand to other food borne pathogens (Campylobacter), produce training manuals in microbiology and epidemiology, and establish regional centers. For more information see: http://www.who.int/salmsurv/en/.
PulseNet is HHS/CDC’s highly successful DNA “fingerprinting” network for detecting food borne bacterial disease clusters and assisting in outbreak investigations in North America. Over the past 4 years, PulseNet USA has developed a close working relationship and partnership with Health Canada in the formation of PulseNet Canada. PulseNet Canada shares its data with PulseNet USA on a real-time basis. This has facilitated early interventions in food borne outbreaks in terms of investigative procedures and public health prevention strategies, thus preventing additional illnesses and possibly saving lives. HHS/CDC is now in the process of facilitating the replication of the PulseNet concept internationally.
A consortium of European scientists headed by the Statens Serum Institut, Copenhagen, Denmark, is working towards the establishment of PulseNet Europe. A feasibility study of PulseNet Europe was completed for three food borne pathogens (Shiga-toxin producing E. coli, Salmonella, and Listeria monocytogenes). The results of this study were presented and discussed at a workshop held in Paris, France on 16 June 2003. PulseNet Europe was successful in obtaining funding from the European Union for 2005.
HHS/CDC, in partnership with the U.S. Association of Public Health Laboratories (APHL), organized a meeting in Honolulu, HI on 12 and 13 December 2002 to explore the possibility of setting up a PulseNet-compatible network in the Asia Pacific region. Fourteen participants from public health laboratories in12 countries/areas in the region attended the meeting. Through interactive brainstorming sessions, the benefits and challenges of forming PulseNet Asia Pacific were discussed, an action plan for the establishment of the network was developed, and a Steering Committee for this network was formed at this meeting. After the Honolulu meeting, several individual countries/areas have worked within their framework to pursue the acquisition of PFGE capabilities. HHS/CDC facilitated the establishment of electronic communications among the participants to stimulate interaction and exchange of information between the participants. The Public Health Laboratory Centre, Hong Kong is coordinating the activities of PulseNet Asia Pacific in close collaboration with the National Institute of Infectious Diseases, Japan. Countries/areas participating in PulseNet Asia Pacific meetings include Australia, Bangladesh, China, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Philippines, Taiwan, Thailand and Vietnam. The first PulseNet training workshop for PulseNet Asia Pacific participants was held in Hong Kong, 15-17 March 2004. Several countries (Hong Kong, Japan, Korea, Taiwan and New Zealand) have already established PulseNet networks and are beginning to actively perform real-time subtyping of food borne pathogenic bacteria. Issues related to funding for establishing and maintaining a central PulseNet database for the Asia Pacific network and for coordinating activities of the network are still to be addressed.
HHS/CDC, in partnership with the Pan American Health Organization (PAHO/INPPAZ), APHL and Instituto Nacional de Enfermedades Infecciosas ANLIS “Dr. Carlos G. Malbrán (Institute Malbrán), organized a meeting in Buenos Aires in December 2003 to explore interest in the region in establishing a PulseNet network. The participants expressed overwhelming support for the establishment of PulseNet America Latina. With high quality administrative support from PAHO/INPPAZ and technical support from Instituto Malbrán, the first PulseNet training workshop was held in Buenos Aires in July 2004. Public health microbiologists from six countries (Brazil, Chile, Colombia, Mexico, Uruguay, and Venezuela) were trained in the first workshop. INPPAZ will house the regional PulseNet database in its facilities in Argentina and provide administrative support and coordination for the network.
The European Community’s RASFF was established to provide control authorities with an effective tool for exchange of information on measures taken to ensure food safety. The legal basis of the RASFF is Regulation (EC) N° 178/2002. Article 50 of this Regulation establishes the RASFF as a network involving the Member States (EU + EFTA/EEA), the Commission, and the European Food Safety Authority (EFSA). Whenever a member of the network has information relating to the existence of a serious direct or indirect risk to human health, this information is immediately notified to the Commission under the RASFF. The Commission immediately transmits this information to the members of the network. Without prejudice to other Community legislation, the Member States immediately notify the Commission under the rapid alert system of:
To assist the members of the network, information is classified under two different headings, Alert Notification and Informational Notifications.
Alert Notifications—Alert notifications are sent when the food or feed presenting the risk is on the market and when immediate action is required. Alerts are triggered by the Member State that detects the problem and has initiated the relevant measures, such as withdrawal/recall. The notification aims at giving all the members of the network the information to verify whether the concerned product is on their market, so that they also can take the necessary measures. Consumers can be reassured that products subject to an alert notification have been withdrawn or are in the process of being withdrawn from the market. The Member States have their own mechanisms to carry out such actions, including the provision of detailed information through the media if necessary.
Informational Notifications—Informational notifications concern a food or feed for which a risk has been identified, but for which the other members of the network do not have to take immediate action, because the product has not reached their market. These notifications mostly concern food and feed consignments that have been tested and rejected at the external borders of the EU. Consumers can be reassured that products subject to an information notification have not reached the market or that all necessary measures have already been taken. The Commission publishes a weekly overview of alert and information notifications. As it is necessary to strike the balance between openness and the protection of commercial information, the trade names and the identity of individual companies are not published. This is not detrimental to consumer protection, as a RASFF notification implies that measures have been or are in the process of being taken.
While not a food borne disease surveillance programme, the Global Environment Monitoring System/Food Contamination Monitoring and Assessment Programmeme, commonly known as GEMS/Food, is an example of a successful, internationally coordinated surveillance effort. GEMS began as a joint project between FAO, the United Nations Environment Programmeme (UNEP), and WHO in 1976. WHO is the implementing agency for the contributing institutions (located in over 70 countries around the world). GEMS’ purpose is to compile data on food contamination and human exposure from different countries for global synthesis, evaluation, and presentation. In 1996, GEMS began developing a new data structure and protocols for the electronic data submission. The protocols involve encoding and formatting data in a manner compatible with the database maintained at WHO headquarters. Protocols for aggregate and individual data on contaminant levels in specific food commodities include descriptions of the data fields needed to ensure complete, quality electronic data submissions. Data may be submitted to GEMS/Food using the compatible Operating Programmes for Analytical Laboratories (OPAL I and II), copies of which can be requested from the GEMS/Food Manager. GEMS data are accessible at the WHO website. Uniform implementation and wide accessibility of the GEMS system make it a model for expanded, international food surveillance efforts.
WHO is in the process of establishing an official International food Safety Authorities Network (INFOSAN) for rapid distribution of specific information concerning food safety. INFOSAN has two major components: 1) INFOSAN Emergency for food safety emergency situations when imminent risk of serious injury or death is present, and 2) an information network for the dissemination of important information about global food safety issues. WHO is in the process of collecting contact point from countries and preparing a handbook for use by the INFOSAN emergency contact points.
While there are no all-encompassing international surveillance systems, examples that serve to illustrate the value of such systems have been illustrated. The structure, function, and interactions between each country’s government agencies form the start of an eventually global surveillance, regulatory, and protective framework to curtail the transmission of food borne diseases. Ultimately, WHO, as the lead international public health organization, could be the focal point of such a global surveillance framework. WHO and FAO, through their collective food safety capability, including the WHO Food Safety Department and the FAO Food Standards Programmeme, could, with the provision of adequate financial and staffing resources, provide the organizational and scientific capability to support a global food borne disease surveillance system.
The Forum may wish to consider the following points regarding international cooperation on food contamination and food borne disease surveillance.