In January 1994, FDA proposed regulations that would require the seafood industry to implement HACCP. FDA plans to issue its final rule on HACCP for seafood in 1995. FDA also took steps toward making this state-of-the-art food safety system the standard for food safety in the United States. In an August 1994 advance notice of proposed rulemaking, FDA announced that it is considering the development of HACCP regulations for other segments of the U.S. food supply, including domestic and imported foods.
FDA also initiated a program to help the agency obtain additional information and experience on whether, and how, to design HACCP systems for foods other than seafood. Seven major food companies have volunteered to participate in FDA's HACCP pilot program, and the products involved represent a wide range of foods, manufacturing processes, and hazards.
In January 1995, FSIS issued a regulatory proposal that would
FSIS proposed that federally inspected meat and poultry plants adopt HACCP systems to provide documentation that their processes are in control and producing safe products.
FSIS proposed that:
These requirements would have to be implemented within 90 days from the date of publication of the final rule and would remain in effect at least until a HACCP system is implemented.
Since FSIS recognizes that ensuring food safety requires taking steps throughout the chain of production, processing, distribution, and sale to prevent hazards and reduce the risk of foodborne illness, FSIS also announced, as part of its Pathogen Reduction/HACCP initiative, its intent to commence rulemaking with FDA to establish federal standards for the safe transportation of foods. FSIS is also working with FDA and the Conference for Food Protection to ensure food safety at the retail level by encouraging states to adopt and enforce consistent, science-based standards, such as FDA's Food Code 1993.
Throughout the development of these HACCP initiatives, FDA and FSIS collaborated closely. For example, FSIS invited FDA to participate in its HACCP round-table discussions. FDA and FSIS regularly share draft documents. More recently, FDA, FSIS, the National Agricultural Library and the Cooperative State Research, Education and Extension Service jointly established a HACCP Training Programs and Resources Database to support the increasing educational information needs of industry and food service professionals in implementing HACCP programs.
The process of encouraging states to update their retail food laws is a multiyear process involving many phases, including FDA development and approval of recommendations, publication, promotion, familiarization, and training of key officials. Once governmental jurisdictions decide to adopt these laws, they must appoint study committees and begin legally required administrative adoption procedures such as publishing proposals and holding public hearings, finalizing the proposed code, and eventually adoption and implementation. Several of these steps can be multi-year endeavors.
Between 1990 and 1993, development and approval of the new food code was completed. It was formally announced in January of 1994; distribution of published copies to government and industry officials began in March, as did FDA efforts to publicize the code.
The agency promoted Food Code 1993 before more than 50 national and regional professional and trade groups during the spring, summer, and fall of 1994. FDA's 20 regional food program specialists also concentrated their efforts toward orienting the states on the new food code. Discussions of the food code were featured in the four FDA/USDA video satellite teleconferences directed at state and local officials, and the key provisions of the code were highlighted in a new exhibit developed by the agency.
In 1994, the agency also initiated its training program in the regions to help state and local officials become familiar with all the provisions of the food code. Week- long, multistate courses have been held or are scheduled for Texas, Rhode Island, Nebraska, Minnesota, Indiana, Maryland, Florida, Nevada, North Dakota, Delaware, Connecticut, Montana, and Missouri.
During 1993, FDA also provided staff support to the Conference for Food Protection to assist in reviewing the new food code provisions. The Conference is now reviewing FDA's Food Code 1993, and during its March 1996 conference, will provide recommendations for further improving the code. The Conference review and recommendation are key steps in developing the consensus that the individual states need to proceed with the adoption process.
Once a state decides to seek adoption, the adoption process usually spans approximately two years. FDA's officials at the national and local level provide necessary technical support for the adoption process.
To assist in the implementation of the new food code, the agency has completed development of the new FDA Electronic Inspection System (EIS). The FDA EIS was designed to be implemented in tandem with adoption of the food code. The new system presents inspectional findings to food establishment operators in a legible understandable report. It also generates reports of inspectional data in many formats helpful to food program managers. The EIS software, documentation, and a user's manual is being provided to all state food program directors and to all FDA-certified state food program officials. The EIS software and documentation are also being made available without cost through downloading from the FDA Prime Connection, the FDA electronic bulletin board for state and local officials.
According to a 1991 CDC study, the number of confirmed cases of foodborne illness in nursing homes is far greater than those from other food service operations. In addition, the percentage of the people who require hospitalization as a result of foodborne illness is far greater in nursing homes, and the case fatality rate is ten times greater than from other foodservice facilities. For example, over 70% of the number of deaths associated with S. enteritidis have involved nursing home residents. After analyzing these findings, FDA and CDC working together undertook several initiatives to respond to the problem.
One initiative was to work with Health Care Financing Administration (HCFA), the federal agency that has jurisdiction over nursing homes, to train the federal, state, and local survey officers who inspect nursing homes about what food service practices they should check.
Another initiative was to provide education for food workers in the nursing home environment. FDA, CDC, and HCFA, therefore, produced a video training package and are promoting it to nursing home operators and medical directors. Based on the success of the training package, FDA (along with input from CDC, HCFA, and FSIS) is updating the video training package and broadening it to include all institutional feeding facilities that serve high-risk audiences.
In July 1995, CDC, FSIS, FDA, and several state public health departments announced a new initiative to collect more precise information about the numbers of people who are affected by harmful bacteria in food. The federal agencies will collaborate with state health departments at five locations nationwide to identify more accurately the incidence of foodborne illness, especially illness caused by Salmonella spp. and E. coli O157:H7. The results will be helpful in monitoring the effectiveness of food safety programs intended to reduce the levels of these pathogens in meat, poultry, eggs, seafood, dairy products, fruits, and vegetables.
The project will collect comprehensive data through laboratory analysis and surveys in well-defined populations to identify foodborne illness incidence, including illness caused by Salmonella spp. and E. coli O157:H7 and the link between these pathogens and foods.
Foodborne diseases are reported to local and state health departments and CDC through passive surveillance systems or laboratory-based reporting systems. These reporting systems rely on the occurrences of a number of events: an individual with foodborne illness seeking medical care, the patient's physician collecting specimens and requesting laboratory analyses, results being sent to state health departments and then to CDC. If any step in the process is missed, the case may go unreported.
For the population-based surveillance project, the collaborating sites will set up a system to actively identify laboratory-confirmed cases of foodborne illness and perform surveys to estimate the actual number of people who become sick with diarrhea each year.
The project is in keeping with the National Academy of Sciences' recommendation for more community-based surveillance of pathogens and foodborne disease incidence in humans to measure the impact of programs aimed at reducing the pathogens in meat and poultry.
A key strategy of the government's approach to education is to base activities on sound research whenever possible. To support education activities, the agencies initiated the following consumer research projects:
The Survey of Consumer Food Handling Practices and Awareness of Microbiological Hazards (the Food Safety Survey) was conducted by FDA in collaboration with FSIS in 1992-1993. This telephone survey had a nationally representative sample of 1,620 adults. It collected information about risk perception related to food safety, awareness of food safety issues, awareness and knowledge of microorganisms associated with foods, food handling practices and food handling knowledge, sources of food safety information, and perceived foodborne illness experiences. The survey is expected to be repeated in 1996.
Focus groups to support development of safe handling statements on labels of meat and poultry products were conducted by FSIS in July 1993. Nine focus groups were conducted with household food preparers to assess preferences for various safe handling information formats.
Focus groups to support consumer education about Vibrio vulnificus in raw oysters were conducted by FDA in the spring and summer of 1995. Six focus groups evaluated progressively refined content areas and messages under consideration as part of the campaign.
The 1995 Behavioral Risk Factor Survey, an annual telephone survey of a representative sample of 1,500 to 2,500 people in each state, includes a food safety module that will be administered to respondents in six states throughout the year. The questionnaire was designed by CDC in collaboration with FSIS and FDA and will be administered by the participating states. Topics include food handling, consumption of high-risk foods (such as raw and undercooked foods of animal origin), and awareness and use of the safe handling information on labels of meat and poultry. The survey is expected to be repeated in 1997.
In addition to research initiatives, the agencies cooperated to maximize the usefulness of data and information on hand. A working group that included FDA, FSIS, and the Economic Research Service met several times a year to plan food safety-related data analysis and research reviews. CDC participated by reviewing reports produced by members of the group. The group has produced an annotated bibliography in several sub-areas of food safety, three papers that were accepted for publication in professional journals, and drafts of several other reports that may be developed into publishable papers.
Over the last several years, FDA, FSIS, and CDC have conveyed education messages in numerous ways on television, on the radio, in print, and on telephone hotlines. The agencies have directed educational efforts to all audiences, including consumers, grocery store workers, fast food workers, childcare providers, state and local officials, and health professionals. Below are a few examples of government initiatives at the national level. These do not reflect the many activities that occur at the local level by USDA's extension agents and FDA's field public affairs specialists.
FDA, FSIS and the Food Marketing Institute jointly developed food safety leaflets on the proper preparation of ground meat and poultry (one for consumers, another for food workers) that were distributed through the nation's grocery stores.
FDA and FSIS jointly developed a food safety information kit and mailed it to over 9000 fast- food restaurants and the national groups and trade press serving the restaurant community.
FDA and the Educational Foundation of the National Restaurant Association are sharing materials, providing training workshops, and conducting training video- teleconferences on implementing HACCP and improving food safety in retail (food service and grocery) markets.
FDA included articles on L. monocytogenes, E. coli O157:H7, and V. vulnificus in the FDA Medical Bulletin that is mailed to over 1 million health professionals.
FSIS and USDA's Food and Nutrition Service jointly developed a packet of food safety publications and mailed them to the 28,000 childcare providers who participate in the USDA Child and Adult Food Programs.
FSIS, working with retail food trade associations, specialty kitchen stores and the media, has launched a major initiative encouraging consumers to use thermometers to assure that meat and poultry products are cooked thoroughly.
FSIS and the School Nurses Association jointly developed a "Safe Hamburger Postcard" and have distributed millions of these carry-home postcards to school children.
The USDA Cooperative Extension Service encouraged joint projects at the local level by devoting a part of its annual $1.5 million Food Safety and Quality grant program to foodborne illness projects.
FSIS and the Women, Infant and Children's (WIC) supplemental feeding program jointly developed a series of food safety videos that can be viewed by mothers as they wait in WIC clinics.
FDA, with a grant made available through the National Marine Fisheries Service, developed an educational campaign targeted to at-risk consumers of raw oysters. In addition to the development and distribution of education materials, FDA is working with the Gulf of Mexico Program (a federal/state task group) to award education grants to local organizations.
FDA placed the Foodborne Pathogenic Microorganism and Natural Toxins Handbook, containing information on 44 different organisms (e.g., E. coli) and toxins (e.g., scromboid poisoning) that cause foodborne illness, on its Internet World Wide Web server. CDC and FSIS are working with FDA to make this a multiagency foodborne disease resource. The Web makes this information more readily available to researchers, health professionals, and consumers.
The Educational Foundation of the National Restaurant Association has established an Industry Council on Food Safety and designated September 1995 as National Food Safety Education Month. The goals are to make food safety training accessible to as many food service workers as possible, and to build public awareness of the industry's commitment to food safety.
FDA and FSIS are also increasing their interaction with the thousands of state and local health and regulatory agencies through multiple communication channels. For example, video satellite teleconferences were conducted on September 2, 1993; May 19, 1994; September 23, 1994; and July 11, 1995 for state and local officials to interact directly with FDA and USDA experts. At each video teleconference it is estimated that 3,000 to 5,000 people viewed the panel discussions involving experts from FDA, FSIS, state agencies, training organizations, and industry. Live call- in question and answer periods ensured that the sessions emphasized two-way communications.
FDA and USDA established a Foodborne Illness Education Information Center at the National Agriculture Library. The Information Center has compiled a database of government and private sector food safety educational materials and programs directed to consumers and food workers in order to facilitate cooperative endeavors, minimize duplication, and identify education gaps. The Information Center, which is accessible via the Internet, is an important new resource for educators and trainers to help them form partnerships and learn from each other's previous initiatives.
The agencies have also established a HACCP Training Programs and Resource Materials Database to support the increasing education information needs of industry and food service personnel in implementing HACCP programs. This database, also accessible via the Internet, provides up-to-date listings of HACCP training programs, HACCP resource materials, and HACCP consultants offering training programs or resources.
Compared with the general population, persons infected with the human immunodeficiency virus (HIV) are more frequently infected with Salmonella, Campylobacter, and Listeria spp. In addition, the infections are more likely to be severe, recurrent or persistent, and associated with extra-intestinal disease. These infections, particularly those pertaining to food hygiene, animal contact, and travel, can be prevented with proper precautions.
In 1994, the U.S. Public Health Service (USPHS), mainly through the efforts of CDC, the National Institutes of Health (NIH) and the Infectious Disease Society of America (IDSA), recognized the importance of preventing opportunistic infections among persons infected with HIV. In response, these organizations initiated an effort to develop comprehensive recommendations for the prevention of opportunistic infections, several of which are foodborne, in HIV-infected persons. Draft recommendations were reviewed by consultants from CDC, NIH, and IDSA as well as members of other federal and non-federal agencies, community organizations, physicians caring for HIV-infected persons, and HIV-infected persons themselves. Comments were solicited from the public and these recommendations were endorsed by the USPHS and IDSA. The recommendations are designed for use of health-care providers, but they can provide useful information for HIV-infected persons.
The Epidemiology and Emergency Response Program (EERP) was created in 1994 to control the incidence of foodborne disease linked to the consumption of meat and poultry products. FSIS works with other federal, state, and local public health officials to detect and control foodborne diseases, to investigate foodborne illness outbreaks, and to integrate food safety issues related to meat, poultry, and eggs into the planning and day-to-day operations at CDC.
The EERP carries out its functions through an emergency response team, an epidemiology team, and a program management team, with Field Epidemiology Officers stationed throughout the country, and others located in Washington, DC and at CDC.
In fiscal year 1995, 3.5 million dollars was awarded to 16 states through the Preventive Health and Health Services Block Grant towards chapter 12 of the Healthy People 2000 objectives. These awards are monitored by CDC, and are used by state health departments to improve surveillance and investigations of foodborne diseases.