Food and Drug Administration
Food Safety and Inspection Service
Centers for Disease Control and Prevention
May 11, 2004

Healthy People 2010 Focus Area Data Progress Review
Focus Area 10: Food Safety
Challenges, Barriers, Strategies and Opportunities

10-1 Reduce infections caused by key foodborne pathogens.

• Foodborne illness is recognized as a significant public health problem in the United States. A 1999 estimate from The Centers for Disease Control and Prevention (CDC) attributes 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths to foodborne pathogens annually⁽¹⁾.
• Data for objective 10.1 are from the Foodborne Diseases Active Surveillance Network (FoodNet), which was established in 1996. FoodNet is an active, population-based surveillance system designed to determine more precisely the burden and severity of foodborne illnesses, and to identify the sources of specific foodborne diseases. FoodNet is a collaborative activity of the CDC, the Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture, (USDA) and ten states (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee).
• To achieve its objectives, FoodNet conducts active, laboratory-based surveillance of sporadic cases of foodborne diseases. FoodNet also conducts surveys in the FoodNet surveillance areas of microbiologic laboratories (to determine which pathogens are included in routine bacterial stool cultures and the specific techniques used to isolate pathogens, etc.); physicians (to obtain information on stool culturing practices); and the population (to obtain an estimate of those who seek medical care).
• CDC recently reported decreases in infections, from 1996-2003, caused by Yersinia (49% reduction), E. coli O157 (42% reduction), Campylobacter (28% reduction), and Salmonella (17% reduction). These declines are evidence of important progress towards the National Health Objectives and Healthy People 2010 objectives.

Challenges and Barriers:

• The burden of foodborne illness is difficult to assess and finding ways to more precisely estimate the total burden in the US population is a challenge. Active surveillance only captures those individuals who were sufficiently ill to seek medical care, whose physicians ordered testing of the correct pathogen on stool culture, and where the pathogen was isolated.
• It is difficult in individual cases to define a source (e.g., food, water, person-to-person contact) of pathogens that cause gastrointestinal illness. Such determinations are conducted in outbreak investigations.
• The FoodNet data are largely limited to foodborne diseases cause by bacteria. Viruses are considered to be the major cause of foodborne illness. Bacteria are the most often confirmed cause of foodborne illness. A proportion of foodborne illness is caused by parasites and by pathogens that have not yet been identified and therefore cannot be diagnosed.
• The incidences of some foodborne infections are increasing. A major challenge is finding ways to reduce the incidence of infections caused by Vibrio species, Salmonella Newport, Salmonella Heidelberg, and Salmonella Javiana.
• Identification of risk factors of foodborne illnesses in children, infants and the elderly is needed to enable us to reduce the high incidence of these illnesses in these populations.

Strategies/Opportunities:

Surveillance, outbreak investigation, research, risk assessment, regulation, guidance, enforcement, coordination, and education are the broad strategies Federal and State agencies and others are using to focus efforts to decrease the number of foodborne illnesses, including decreasing the number and size of foodborne illness outbreaks.

In April 2003, the National Academy of Sciences (NAS) issued a final report entitled "Scientific Criteria to Ensure Safe Food", that concluded that performance standards are a useful "score card" for measuring process control by food processors and recommended that efforts be made to link such scientific criteria to improvements in public health. NAS recommended, among others, development of a comprehensive plan to harmonize disease surveillance and microbial prevalence data, and the adoption of science-based strategies in developing food safety criteria.

Surveillance:

Surveillance systems, both passive and active, alert States, CDC, FDA, and FSIS to cases and increases of foodborne illness. Disease surveillance and epidemiological investigations provide information to use in outbreak investigation and in tracebacks to food products, or to facilities, so that the remaining product can be removed from the market and other corrections or interventions can be made.

• FoodNet (described above) is exploring statistical/epidemiologic methodologies to more precisely determine the burden of foodborne illnesses in the U.S. population.
• PulseNet is a national network of public health laboratories that performs DNA "fingerprinting" on bacteria that may be foodborne. The network permits rapid comparison of these "fingerprint" patterns through an electronic database at CDC. The DNA "fingerprinting" method is called pulsed-field gel electrophoresis (PFGE).
• CaliciNet will help "fingerprint" strains of Calicivirus (includes Noroviruses, previously named "Norwalk-like viruses") that may cause foodborne outbreaks.
• EHS-Net is a network of environmental health specialists and epidemiologists who facilitate the exchange of information about environmental causes of foodborne illness. This project is a collaborative effort of CDC's National Center for Environmental Health (Environmental Health Services Branch), FoodNet, and the Food and Drug Administration (FDA). Eventually EHSNet will refine data on retail food service-associated outbreaks that will help CDC/FDA/States evaluate Food Code issues.
• CAERS, the CFSAN Adverse Events Reporting System, is a new system for tracking and analyzing adverse event reports involving foods, cosmetics and dietary supplements. CAERS will be used as a monitoring tool to identify potential public health issues that may be associated with the use of a particular product already in the marketplace.
• EFORS, the Electronic Foodborne Outbreak Reporting System, is CDC's new internet-based system designed for state health departments to report foodborne disease outbreaks. EFORS is making the reporting of data more timely and anticipates providing data more quickly on a routine basis.
• eLEXNET, the electronic Laboratory Exchange Network, is a seamless, integrated, secure network that was developed by FDA to provide access to critical food testing data from Federal (FDA, USDA, and DOD), State, and local food safety laboratories. One hundred laboratories representing all 50 states are participating eLEXNET, and there is interest from international laboratories. eLEXNET allows health officials engaged in food safety activities to compare, share, and coordinate laboratory analysis findings on food products.

Regulation, Guidance, Enforcement:

• FDA and FSIS implemented Hazard Analysis Critical Control Point (HACCP) systems regulations for seafood (1997), meat and poultry (1998), and juice products (2002). HACCP is an internationally recognized, scientific approach to producing safer food by anticipating how biological, chemical, or physical hazards are most likely to occur and by installing appropriate measures to prevent them from occurring.
• The Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations are general regulations that apply to all foods FDA regulates. In addition, there are specific CGMP regulations that apply to specific food categories.
• FDA enforces regulations through inspection and sampling.
  • Surveillance samples are samples collected when there is no prior knowledge or evidence that a specific food shipment contains pathogens, illegal pesticides, or other chemical residues.
  • Compliance samples are taken as follow-up to the finding of pathogens or illegal residues or when other evidence, such as foodborne illness, indicates that a problem may exist. Federal, State and local agencies cooperate in traceback investigations and collect compliance samples following foodborne disease outbreaks.
• Regulatory programsfor retail, milk, and shellfish involve a cooperative effort among FDA, States, and the industry to regulate production or harvesting of these foods.
• Guidance, such as FDA's Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (also known as "Good Agricultural Practices" or "GAPs," http://www.foodsafety.gov/~dms/prodguid.html), the FDA Food Code (for retail level establishments http://www.cfsan.fda.gov/~dms/foodcode.html ) as well as specific technical assistance have been provided to producers (growers), processors, the States, and other countries.
• In 1999, 2373 federally inspected and 170 state inspected meat and poultry plants implemented HACCP. In 2000, HACCP was implemented in over 3400 federally inspected and 2300 state inspected plants. FSIS recognized that both small and very small plants would need additional guidance and assistance that the large plants that implemented HACCP in 1998 did not require. To meet their needs, several outreach programs have been established and implemented. All the information, materials, guidance, and outreach efforts of FSIS are provided to federal and state plants at no charge.
• FSIS recognized early during HACCP implementation that both small and very small plants would need guidance and assistance that the large plants did not require. The Small and Very Small Plant Outreach Program was established in 1998 to provide technical guidance, assistance and resource materials to small and very small plants so they can meet their responsibilities for maintaining effective food safety systems to produce safe products. The Small and Very Small Outreach Program built and continues to maintain an infrastructure with university extension agents, university professors, and state program directors that are located in all 50 States; Washington, D.C.; Puerto Rico; and the Virgin Islands. Small and very small plants can utilize these contacts for guidance and assistance; information on HACCP-related training classes; obtain HACCP and food safety resource materials; and assistance in plan development. The outreach program provides small and very small plants with the latest information on foodborne hazards, information on up-to-date procedures and technologies and guidelines. All the information, materials, guidance, and outreach efforts of FSIS are provided to federal and state plants at no charge.
  • The outreach program promotes the development of HACCP and food safety related information, materials and education to small and very small plants by providing support to educational institutions, including the 1890 Colleges, Land Grant Universities, Historically Black Colleges and Universities, Tribal Colleges and Hispanic Universities, allowing them to offer low cost educational classes and materials to plant owners and/or operators that may not otherwise be able to afford such training. To help plant owners and operators with new food safety regulations, the Small and Very Small Plant Outreach Program offers workshops across the country on food safety hazards such as Listeria monocytogenes, Bovine Spongiform Encephalopathy (BSE) and E. coli O157:H7. The outreach program also extends its outreach efforts to Native American populations and Alaska natives by coordinating efforts to provide food safety seminars and workshops that include topics such as HACCP, identification of foodborne illnesses, lamb slaughter in Navajo or country settings, beef jerky and lamb operations, and safe food handling from farm to table.

Education and Training:

Safe food preparation and storage education and training have been provided and additional programs are being developed for regulators, industry (processors, retail, and food service), consumers, and medical health professionals.

• In April 2004, the FDA, CDC, FSIS, the American Medical Association, and the American Nurses Association-American Nurses Foundation collaboratively produced and released Diagnosis and Management of Foodborne Illnesses, A Primer for Physicians and Other Healthcare Professionals as an educational resource to help primary care physicians and other health professionals recognize, diagnose and treat foodborne illness. The Primer also provides patient education handouts emphasizing the four key food safety behaviors. The Primer, initially introduced in 2001, contains five new sections on new and re-emerging foodborne illnesses and was written with an emphasis on living in the post 9-11 environment. http://www.fda.gov/bbs/topics/news/2004/NEW01047.html Healthcare professionals can request free copies from the FDA ( or ), or access it online. www.ama-assn.org/go/foodborne.
• The Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (also known as the "Bad Bug Book") brings together in one place basic facts on foodborne agents, from FDA, CDC, USDA/FSIS, and the National Institutes of Health. The material has been updated with new scientific information or links to foodborne outbreak reports. http://www.cfsan.fda.gov/~mow/intro.html
• In 2003, FSIS introduced a new educational campaign designed to reach millions of consumers with food safety messages. The campaign's centerpiece is the Food Safety Mobile, which travels the country delivering food safety education and developing partnerships at the local level. For the communities the Mobile visits, representatives from the national level are teamed with community leaders to provide answers for consumers on national and local issues. Partners with the USDA Food Safety Mobile come from all over the community: universities and cooperative extension, state and local public health, agriculture, and other government agencies, FSIS field offices, grocery stores, schools, and many others.
• The Center for Food Safety and Applied Nutrition's Outreach and Information Center (O&IC) opened in September 1999. The O &IC enhances FDA's ability to provide accurate and meaningful information to the public about food safety. In addition to providing food safety information, the O&IC provides assistance with other CFSAN issues including, nutrition, dietary supplements, food labeling, cosmetics, food additives, and food biotechnology. 1-888-SAFEFOOD (1-888-723-3366)
• FSIS provides a toll-free telephone service to prevent foodborne illness by answering consumer questions in English or Spanish on safe storage, handling, and preparation of meat, poultry, and egg products through the USDA Meat & Poultry Hotline (1-800-256-7072). Another resource for consumers is "Ask Karen," a virtual representative available on the FSIS home page for answering consumer questions at: http://www.fsis.usda.gov/Home/index.asp
• Examples of recent, ongoing, and planned education campaigns, including national, regional, local, and school-based programs, are included in the "Strategies and Opportunities" section of Objective 10-5 (page 20) and in the this section of this Progress Review Briefing book.

Research and Technology Transfer:

• FDA, FSIS and others have developed microbiological risk assessments on particular organisms (Salmonella spp., Listeria monocytogenes, Vibrio parahaemolyticus, Vibrio vulnificus, Escherichia coli O157:H7, bovine spongiform encephalopathy, and Clostridium perfringens) with the goal of identifying and focusing prevention efforts on the riskiest products and procedures or steps in the farm to fork continuum.
• FDA conducts and participates in research to lower the incidence of and to detect and identify foodborne pathogens.
• Since 1998, FDA's Center for Food Safety and Applied Nutrition (CFSAN) has operated a competitive extramural research program to augment its food safety research and provide for critically needed research to characterize foodborne hazards more rapidly and accurately, to provide the tools for regulatory enforcement, and to develop effective interventions that can be used to prevent hazards at each step from production to consumption.
• FDA has awarded grants each year since 1999 to State and local regulators to fund innovative programs designed to enhance food safety. These programs address specific objectives of Healthy People 2010 to decrease risks of foodborne disease in such diverse settings as animal feed plants, juice/cider operations, grocery stores, and schools.
• USDA Cooperative State Research, Education and Extension Service (CSREES) funds food safety research in the area of food safety, particularly emphasizing the detection, prevention and control of food-borne disease-causing microorganisms and naturally occurring toxicants. Food safety grant programs include Ensuring Food Safety and Epidemiological Approaches for Food Safety.
• The USDA Agricultural Research Service Food Safety Program addresses prevention and control of food pathogens, the production, harvesting, processing, transportation, handling, and storage of food (the farm to table continuum), and the prevention of toxic chemical hazards in food through research programs that benefit producers, processors, and the public. ARS coordinates its food safety research to meet the needs of the Federal agencies, in particular the USDA-Food Safety and Inspection Service, and the FDA-CFSAN. During 2002, collaborative research programs were continued with the National Alliance for Food Safety to specifically address issues relative to pathogen reduction including robustness of predictive models for Listeria growth and inactivation in ready-to-eat meat and poultry products and role of nematodes in preharvest contamination of fresh fruit and vegetables. Collaborative postharvest research programs were continued with the Institute for Genomic Research (TIGR) to provide annotated genomic sequences of the bacterial pathogens Listeria monocytogenes and Campylobacter jejuni. See http://www.jifsr.gov/ppd/ars010b.htm.
• FSIS is implementing a broad, long-term, science-based, farm-to-table strategy to improve the safety of meat, poultry, and egg products at each step in the food production, processing, distribution, and marketing chain to better protect public health. These steps are designed to focus attention on the risk of microbial contamination. FSIS' goal is to build the principle of prevention into the production and inspection processes and to foster the development and use of new technology. FSIS is seeking state, academic, and research institutions to work cooperatively in identifying, developing, and validating new technologies that are economically viable for small/very small meat, poultry, or egg product plants to help them meet food safety requirements. See http://www.fsis.usda.gov/oa/topics/newtech.htm#Technology
• FSIS release a food safety vision document, "Enhancing Public Health: Strategies for the Future" in July 2003, outlining several key initiatives the agency is implementing to enhance meat and poultry safety and improve food inspection systems. http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oa/programs/vision071003.htm

10-1a. Campylobacter

• The main route of transmission of Campylobacter to humans is foodborne, via undercooked meats and meat products, as well as unpasteurized and contaminated milk. The ingestion of contaminated water is also a recognized source of infection.

Challenges and Barriers:

• Based on FoodNet data, Campylobacter was identified as the most frequently isolated bacterium from persons with diarrhea.
• The species is widely distributed and occur in most warm-blooded animals. They are prevalent in food animals such as poultry, cattle, pigs, sheep, ostriches and shellfish, as well as in pets, including cats and dogs. The wide occurrence of the organism hinders the development of strategies to control Campylobacter in the food supply from farm to table.
• FSIS baseline testing conducted in 1994-1995 estimated the prevalence of Campylobacter on raw chicken carcasses to be 88%. (http://www.fsis.usda.gov/OPHS/baseline/contents.htm).
• Campylobacter is a difficult organism to culture and there is an ongoing search for optimal detection, enumeration and identification methods.

Strategies/Opportunities:

• FoodNet is conducting a case-control study of sporadic cases of Campylobacter in young children to identify risk factors for infection, regional differences in incidence of infection, and opportunities for prevention.
• FSIS conducted baseline testing for Campylobacter in 1994-1995 and in 1999-2000 to quantify Campylobacter on raw chicken carcasses. The baselines are currently undergoing review by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).
• Pasteurization of milk and treatment of municipal water supplies eliminate another route of transmission for Campylobacter and other bacteria.
• FDA assists States in preventing disease transmitted through milk and helps to enforce State milk regulations. It promotes and helps to ensure compliance with the model Grade A Pasteurized Milk Ordinance (http://www.cfsan.fda.gov/~ear/pmo01toc.html ), a document similar to the Food Code.

10-1b. Escherichia coli O157:H7--Hemorrhagic colitis

• Escherichia coli serotype O157:H7 is the fourth most common cause of bacterial diarrhea in the United States. Each strain produces one or more related, potent Shiga toxins that cause severe damage to the lining of the intestine. The toxins are similar to the toxin produced by Shigella dysenteriae type 1.
• Illness is characterized by diarrhea, often with large quantities of blood, so the illness is sometimes called hemorrhagic colitis. About 10% of hemorrhagic colitis victims, particularly the very young, may develop the hemolytic uremic syndrome (HUS--see objective 10-1f). Adults with E. coli O157-associated HUS are sometimes given the diagnosis of thrombotic thrombocytopenic purpura (TTP), a disease with some similar features but of unknown etiology.
• Consumption of undercooked or raw hamburger (ground beef) is the single most common cause of illness. However, many other foods, including alfalfa sprouts, unpasteurized fruit juices, dry-cured salami, lettuce, game meat, and raw milk and cheese curds have been implicated in many of the documented E. coli O157:H7 outbreaks.

Challenges and Barriers:

• Fewer than 60% of U.S. clinical laboratories routinely test all stool samples submitted for microbiologic culture for E. coli O157:H7; therefore, many infections due to this pathogen that are severe enough to require medical attention go undiagnosed and unreported.

Strategies/Opportunities:

• PulseNet, a system of "fingerprinting" strains using pulsed-field gel electrophoresis (PFGE), is enhancing detection of outbreaks of infections with E. coli O157, and is refining case definitions for case-control studies to decrease misclassification error.
• FSIS took several actions in its effort to reduce the incidence of E. coli O157:H7 on products it regulates, including the following:
  • Based on evidence of the higher prevalence estimates of E. coli O157:H7 on ground beef, FSIS required establishments that produce raw beef products to reassess their HACCP plans in light of these data to determine whether E. coli O157:H7 is a hazard reasonably likely to occur in their production of these products, and, if so, whether their HACCP plans appropriately address this hazard (67 FR 62325). See http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/00-022N.pdf and FSIS Directive 10.010.1 http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10.010.1.pdf
  • FSIS modified its sampling and testing program for E. coli O157:H7 to eliminate existing exemptions, so that FSIS tests product at all ground beef plants it inspects.
  • FSIS conducted a risk assessment on E. coli O157:H7 in ground beef (See http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/00-023N/00-023NReport.pdf and presented it to the National Academy of Sciences (NAS) for review. The risk assessment is currently being modified according to suggestions made by NAS (http://www.nap.edu/books/0309086272/html/) and to address additional questions generated by FSIS' policy office. FSIS also conducted a comparative risk assessment of intact (non-tenderized) and non-intact (blade tenderized) steaks that was reviewed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). NACMCF found that non-intact (tenderized) beef does not pose a greater risk of illness than intact beef if it is oven broiled and cooked to an internal temperature of 140⁰F (45.8°C) or more. (http://www.fsis.usda.gov/OA/topics/o157.htm).
  • FSIS has prepared various guidance documents to help industry reduce the occurrence of E. coli O157: H7 (http://www.fsis.usda.gov/OA/topics/o157.htm).
• Similarly, FDA took several actions in its effort to reduce the incidence of E. coli O157:H7 on products it regulates, including the following:
  • Following multiple outbreaks of infections with Salmonella and E. coli O157:H7 linked to orange and apple juice consumption, FDA requires (starting in 2002) the fresh juice industry to implement a HACCP plan. FDA requires juice manufacturers to achieve a 100,000-fold (5-log) reduction in the numbers of harmful pathogens in their finished products compared to levels that may be present in the untreated product. The juice processors are free to employ microbial reduction methods other than pasteurization, including scrubbing, anti-microbial solutions, or alternative technologies.
  • In 2002 through 2004 FDA published draft and finalized guidance for the juice industry:
    • Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction October 7, 2002 http://www.cfsan.fda.gov/~dms/juicgui6.html
    • Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices April 24, 2003 http://www.cfsan.fda.gov/~dms/juicgui8.html .
    • Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing June 2003. http://www.cfsan.fda.gov/~dms/juicgui9.html .
    • Guidance for Industry: The Juice HACCP Regulation September 14, 2003 http://www.cfsan.fda.gov/~comm/juiceqa2.html .
    • Guidance for Industry: Juice HACCP Hazards and Controls Guide, March 3, 2004. http://www.cfsan.fda.gov/~dms/juicgu10.html
  • FDA included in the Food Code additional safeguards for highly susceptible populations on juice, eggs, and raw animal foods. See http://www.cfsan.fda.gov/~dms/fc-3.html
  • E. coli O157:H7 infections have also been associated with produce. FDA works with CDC and States in produce outbreak investigations and performing follow-up inspections.
    • FDA developed and provided Good Agricultural Practices guidance and training, and other technical assistance, both domestically and abroad to decrease infection associated with produce. See http://www.foodsafety.gov/~dms/prodguid.html
    • FDA developed specific guidance for processors such as sprout growers. See http://www.cfsan.fda.gov/~lrd/hhsprout.html

10-1c. Listeria monocytogenes

• Foods associated with sporadic listeriosis in the United States have included soft cheese, undercooked poultry, hotdogs not thoroughly re-heated, and deli food. Listeriosis outbreaks in the United States have been associated with lettuce (1979), contaminated milk (1983), Mexican-style soft cheese made with unpasteurized milk (1985), ice cream or salami (1986-87), shrimp (1989), hotdogs and cold cuts (1998-99), and sliced turkey deli meat (2002).
• The estimated annual incidence of foodborne listeriosis in the United States is 2518 cases and 499 deaths, an approximate 20 % case fatality rate⁽²⁾. These data confirm that, although foodborne listeriosis is rare, the associated mortality rate is high among those who are most at-risk. Populations highly susceptible to L. monocytogenes include fetuses and newborns, the elderly, diabetics, and those with compromised immune systems (cancer, AIDS, steroid use). Severe disease forms included meningitis and septicemia, and in pregnant women, listeriosis may result in miscarriage or stillbirth, or meningitis and septicemia in the newborn.

Challenges and Barriers:

• L. monocytogenes is found widely distributed in the environment and livestock, and is often found in vegetables and uncooked meat. Contamination after thermal processing is the major food safety concern for L. monocytogenes. Because L. monocytogenes is often present in raw ingredients and is heat-resistant, proper cooking is important to assure destruction of the organism.
• L. monocytogenes contamination most often occurs when a product or food contact surface is contaminated between the cooking and packaging steps. L. monocytogenes can also be introduced through employees, equipment, animals, environmental reservoirs, or ingredients
• Unlike most other bacterial pathogens, L. monocytogenes can grow at refrigeration temperatures. The unusual growth and survival properties of the organism and its ability to adhere to food contact surfaces contribute to the complexity of eliminating it from the food-processing environment. Persistent strains may develop due to physical adaptation such as surface attachment or biofilm formation, as well as to a range of environmental conditions.
• Encouraging physicians to request appropriate testing of stool specimens, particularly for Listeria monocytogenes among pregnant women and among those with weakened immune systems, would improve both treatment and data available.

Strategies/Opportunities:

• PulseNet, a system of "fingerprinting" strains using pulsed-field gel electrophoresis (PFGE) is enhancing detection of outbreaks of infections with L. monocytogenes, and is refining case definitions for case-control studies to decrease misclassification error.
• FDA and CDC enhanced disease surveillance and outbreak response through listeriosis case control studies. Work is on-going in FoodNet to develop a system that will facilitate prompt interviewing of all patients with listeriosis and will rapidly link exposure data with PFGE results.
• FDA, FSIS, and CDC conducted an extensive risk assessment for L. monocytogenes. The risk assessment was designed to predict the potential relative risk of listeriosis among three age-based groups of people, perinatal, elderly, and intermediate-age, from eating certain ready-to-eat foods. The agencies released a draft report in 2001 and a final report in September 2003. This study predicted the highest risk foods, on a yearly consumption basis, to be deli meats, pasteurized fluid milk, high fat and other dairy products, and un-reheated frankfurters. See http://www.foodsafety.gov/~dms/lmr2-toc.html
• The FDA/USDA Listeria Joint Action Plan (2001) was designed to reduce the risk of illness caused by L. monocytogenes by 50 percent by 2005, five years ahead of the previously established Healthy People 2010 target. This plan included consideration of control measures for at-risk foods; publication of guidance for processors, retailers, and food service facilities; and consideration of enhanced labeling to provide additional safeguards for consumers.
  • The FDA/CDC 2003 Update of the Listeria Action Plan is to provide guidance for processors that manufacture or prepare ready-to-eat foods and for retail and food service and institutional establishments; provide training and technical assistance for industry and food safety regulatory employees; enhance consumer and health care provider information and education efforts; review, redirect, and revise enforcement and regulatory strategies, including microbial product sampling; enhance disease surveillance and outbreak response; coordinate research activities to refine the Risk Assessment, enhance preventive controls, and support regulatory, enforcement, and educational activities. See http://www.cfsan.fda.gov/~dms/lmr2plan.html
• In recent years, FSIS has been involved in a number of activities to address contamination of products with Listeria including the following:
  • Requiring companies in 1999 to reassess HACCP plans to address Listeria in the hazard analysis (http://www.fsis.usda.gov/FOIA/notices/23-99.htm);
  • Releasing Directive 10,240.3, "Microbial Sampling of RTE Products for the FSIS Verification Testing Program," effective December 9, 2002, that specifies that FSIS will conduct intensified multiple product and environmental sampling to test for Listeria in establishments that produce products at the most risk of contamination and that either do not have an evaluated environmental testing regime as part of a control program or choose not to share data from existing programs on an ongoing basis;
  • Releasing a risk assessment addressing contamination of ready-to-eat meat and poultry products in February 2003 http://www.fsis.usda.gov/OPHS/lmrisk/DraftLm22603.pdf and releasing a draft risk assessment addressing L. monocytogenes contamination of deli meats in May 2003 http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-013F/ListeriaReport.pdf
  • Publishing an interim final rule June 6, 2003, in the Federal Register requiring official establishments that produce certain ready-to-eat meat and poultry products to take steps to further reduce the incidence of L. monocytogenes). The rule was implemented in October 2003;
  • Releasing Directive 10, 240.4, "Verification Procedures for the Listeria monocytogenes Regulation and Microbial Sampling of Ready-to-Eat (RTE) Products for the FSIS Verification Testing Program," October 2003, that provides instructions for FSIS inspection personnel for verifying whether establishments are complying with the regulations, including those for ready-to-eat products; and
  • Conducting five interactive workshops in September/October 2003 for small/very mall plants to prepare them to implement FSIS Directive 10.240.4.
• CDC, FDA, and FSIS have cooperatively produced education materials and programs for retail delicatessens and for consumers to help reduce the incidence of listeriosis, and some of these materials are available in Spanish.
• In 2001, the Association of Women s Health, Obstetric and Neonatal Nurses (AWHONN), the International Food information Council (IFIC) Foundation, USDA/FSIS and DHHS (FDA and CDC) issued an advisory (available in English and Spanish) designed specifically for pregnant women, describing their risk from listeriosis and how to avoid it. See http://www.fsis.usda.gov/OA/pubs/lm_tearsheet.htm , http://www.cfsan.fda.gov/~dms/adlister.html , http://www.fda.gov/bbs/topics/NEWS/2002/NEW00836.html

10-1d. Salmonella spp.

• An estimated 1.4 million cases of salmonellosis occur annually in the United States, with more than 500 fatal cases each year. Approximately 2000 serotypes are known to cause disease in humans. Salmonella Enteritidis and Salmonella Typhimurium, combined, cause half of all Salmonella infections in the U.S.

Challenges and Barriers:

• Non-typhoidal Salmonella is the third most commonly reported cause of foodborne illness in the United States. A comprehensive farm-to-table approach to food safety is necessary for control. Farmers, industry, food inspectors, retailers, food service workers, and consumers are each critical links in the food safety chain.
• The incidences of foodborne infections caused by some strains of Salmonella are increasing. A major challenge is finding ways to reduce the incidence of infections caused by Salmonella Newport, Salmonella Heidelberg, and Salmonella Javiana.

Strategies/Opportunities:

• In addition to FoodNet surveillance, the National Salmonella Surveillance System collects reports of isolates of Salmonella from human sources from every state in the United States. State Public Health Laboratory Directors and State and Territorial Epidemiologists report this information to CDC through the Public Health Laboratory Information System (PHLIS).
• FSIS began implementing the HACCP system in 1998 for meat and poultry and it was fully implemented in 2000. Included in HACCP were performance standards for Salmonella that establishments must meet for FSIS to verify that they are within regulatory compliance. The proportion of samples positive for Salmonella collected through Salmonella HACCP compliance testing has been well below the established performance standards and has generally tended to decrease each year (which correlates with drops in foodborne illness reported by the CDC). See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5115a3.htm
  • FSIS issued new procedures through FSIS Directive 5000, May 21, 2003 http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5000.1Rev1.pdf for responding to establishments that fail Salmonella performance standard testing for raw products. These procedures constitute a more scientific and systematic approach to food safety and to the enforcement of current regulations. The procedures accelerate the review of a plant's HACCP plan and involve higher level supervisors at an earlier stage than previous procedures and emphasize coordination between personnel at various levels in the field to address inspection failures.
  • FSIS received recommendations from the NACMCF for improving FSIS' use of performance standards in evaluating microbiological contamination of food products, which included gathering quantitative data and designing statistically valid studies to determine prevalence estimates for proper risk assessments. See http://www.fsis.usda.gov/OPHS/nacmcf/2002/rep_stand2.pdf
  • FDA enforces the seafood HACCP regulation to reduce infections from food pathogens including Salmonella spp. Since the Healthy People 2010 Food Safety objectives were developed and published, FDA has published and implemented HACCP regulations for juice, as well as guidance to industry for achieving 5-log reduction of pathogens, including Salmonella spp., in juice. FDA developed and provided Good Agricultural Practices guidance and training, and other technical assistance, both domestically and abroad to decrease infection associated with produce. See http://www.foodsafety.gov/~dms/prodguid.html FDA developed specific guidance for processors such as sprout growers. See http://www.cfsan.fda.gov/~lrd/hhsprout.html
• See also strategies for E. coli O157:H7 under 10-1b and see other FDA surveillance, regulatory and educational efforts for Salmonella spp. under 10-2b.

10-1e. Cyclospora cayetanensis

• Cyclospora cayetanensis (previously termed "cyanobacterium-like body") is a recently characterized coccidian parasite. The first known cases of infection in humans were diagnosed in 1977. Before 1996, only three outbreaks of Cyclospora infection had been reported in the United States.
• In 1997, CDC received reports of outbreaks of cyclosporiasis from eight states in the United States and one province in Canada that were associated with events that occurred during March -May and comprised approximately 140 laboratory-confirmed and 370 clinically defined cases of cyclosporiasis. CDC coordinated epidemiological investigations into the outbreaks with State and FDA cooperation. Fresh, spring-grown raspberries from Guatemala were identified as the probable vehicle of infection for most of these outbreaks of cyclosporiasis. Guatemalan berry growers voluntarily suspended shipment of fresh raspberries to the United States.

Challenges and Barriers:

• The United States continues to have a very low incidence of cyclosporiasis (0.1 cases per 100,000 population in 2002). Because of its very low incidence, the Food Safety Working Group has chosen to drop this developmental objective from the focus area and to focus on higher incidence pathogens.
• Reporting of cyclosporiasis, as for other pathogens, is dependent on isolation of the organism (oocyst), requiring special analytical methods. Few labs test for this pathogen and few physicians order the test.
• The Cyclospora oocysts have been difficult to detect in food matrices.

Strategies/Opportunities:

• Following the 1997 cyclosporiasis outbreaks, FDA implemented a number of measures to prevent future occurrences in berries from Guatemala and other countries:
  • FDA worked with the CDC, the Guatemalan government and the Guatemalan Berries Commission in 1997 and succeeding years to determine when the country might resume shipment of fresh raspberries to the United States. FDA provided follow-up inspection and guidance to the growers in Guatemala.
  • FDA developed a method for concentration and preparation of Cyclospora from berries for the polymerase chain reaction (pcr) and for microscopy and made this available through the FDA's Bacteriological Analytical Manual, Online in 2001: http://www.cfsan.fda.gov/~ebam/bam-19a.html
  • FDA continues to provide technical assistance to other governments and growers in the forms of guidance and training on preventing Cyclospora contamination of produce and analytical methods for isolating and identifying the organism. In November 2002, FDA completed a farm investigation and training course in Chile as follow-up to a cyclosporiasis outbreak implicating raspberries from Chile.
• DPDx, Identification and Diagnosis of Parasites of Public Health Concern, with emphasis on Intestinal and Foodborne Parasites, uses the Internet to strengthen diagnosis of parasitic diseases both in the United States and abroad and will enhance CDC's capacity to address the global problem of parasitic diseases.

10-1f. (Developmental) Hemolytic uremic syndrome, postdiarrheal

• Postdiarrheal hemolytic uremic syndrome (HUS) is a life-threatening illness characterized by hemolytic anemia, thrombocytopenia, and renal injury. Because there are no diagnostic tests specifically designed for HUS, surveillance efforts rely on recognition of the syndrome by physicians.
• HUS can occur in persons of any age. The syndrome of HUS is fairly distinctive in children, and HUS is the major cause of acute renal failure in this age group. In adults, HUS may be confused with thrombotic thrombocytopenic purpura (TTP), a disease of unknown etiology.
• HUS typically develops about a week after a diarrheal illness caused by Shiga toxin-producing E. coli. Current data suggest that 80% or more cases of postdiarrheal HUS are due to E. coli O157:H7 and the remainder are largely due to non-O157 Shiga-toxin-producing E. coli.
• HUS can lead to permanent loss of kidney function and other severe complications. Death occurs in 5% of children and a larger proportion of the elderly.

Challenges and Barriers:

See information under objective 10.1b, E. coli O157:H7.

Strategies/Opportunities:

• Sufficient, nationally representative data from FoodNet are now available to move this objective from "developmental" status to "measurable," and the available data are provided in the data tables and charts. The Food Safety Work Group is proposing this status change to the Healthy People Steering Committee for consideration during the June 2004 meeting.
• The proposed objective is: Reduce cases of postdiarrheal hemolytic uremic syndrome (HUS) in children less than 5 years of age. The 1997 baseline is 1.36 cases per 100,000 children under age five and the 2010 goal will be a 50% reduction to 0.7 cases per 100,000.
• Crude incidence rates are presented for HUS. This analysis is restricted to HUS-diagnosed patients who reside in the FoodNet catchment area and are less than five years of age.
• See information under objective 10.1 b, E. coli O157:H7.

10-1g. Congenital Toxoplasma gondii

• Toxoplasma gondii, cause of the disease toxoplasmosis, is a single-celled, microscopic parasite found throughout the world. The cat is the definitive host in the reproductive cycle of this parasite. The infective stage (oocyst) develops in the gut of the cat. The oocysts are then shed into the environment with cat feces.
• People get toxoplasmosis the following ways:
  • By consuming foods (such as raw or undercooked meats, especially pork, lamb, or wild game) or drinking untreated water (from rivers or ponds) that may contain the parasite.
  • Fecal-oral: Touching hands to mouth after gardening, handling cats, cleaning a cat's litter box, or anything that has come into contact with cat feces.
  • Mother-to-fetus (if mother is pregnant when first infected with T. gondii).
  • Through organ transplants or blood transfusions, although these modes are rare.

Challenges and Barriers:

• Challenges in preventing toxoplasmosis include educating pregnant women (or women of childbearing age) in all racial/ethnic groups about the importance of avoiding ingestion of undercooked or raw meat; washing hands, cutting boards, counters, knives and utensils after preparing raw or undercooked meat; and thoroughly washing the soil off all fruits and vegetables that are eaten raw.
• Toxoplasmosis Incidence data are not collected through FoodNet. Although it has been proposed for inclusion on the list of nationally notifiable diseases, toxoplasmosis was not added. A database of cases is not available for determining a baseline or setting a target. Thus, the Food Safety Work Group is recommending that this developmental objective be dropped during the Midcourse Review.

Strategies/Opportunities:

• Easy to read fact sheets about toxoplasmosis-related prevention are now available on the CDC Web site. The Division of Parasitic Diseases is also developing a new pamphlet about preventing congenital toxoplasmosis that will be available on the CDC Web site. It is important that CDC, State, and local health departments make these prevention materials available in multiple languages (appropriate for each State) so that prevention messages can reach all racial/ethnic groups.
• A recent survey of pregnant women in the U.S. conducted by the American College of Obstetricians and Gynecologists indicated that pregnant women were most likely to hear about toxoplasmosis from "magazines or books on pregnancy and childbirth." These media are likely to be very helpful for targeting preventive messages.
• In addition, the government and meat industry should continue efforts to reduce Toxoplasma gondii in meat.

10-2. Reduce outbreaks of infections caused by key foodborne bacteria

10-2a. Escherichia coli O157:H7 Outbreaks

• PulseNet is enhancing detection of outbreaks of infections with E. coli O157:H7 and Listeria monocytogenes, and is refining case definitions for case-control studies to decrease misclassification error.
• EFORS, the Electronic Foodborne Outbreak Reporting System, is CDC's new internet-based system designed for State health departments to report foodborne disease outbreaks.
• For Challenges and Strategies, see objective 10-1b.

10-2b. Salmonella serotype Enteritidis Outbreaks

• Salmonella serotype Enteritidis (SE) isolations from humans emerged in the United States in the 1980's. SE continues to cause sporadic illnesses and outbreaks.

Challenges and Barriers:

• Control of SE is complicated by the presence of the organism inside the yolk of the egg. Vertical transmission, that is, deposition of the organism in the yolk by an infected layer hen prior to shell deposition, is thought to be the primary method of spread of the organism, with shell eggs identified as the most common vehicle. Foods other than eggs have also caused outbreaks of SE disease.

Strategies/Opportunities:

• In addition to FoodNet surveillance and EFORS for outbreak reporting from each state, the National Salmonella Surveillance System collects reports of isolates of Salmonella from human sources from every state in the United States. State Public Health Laboratory Directors and State and Territorial Epidemiologists report this information to CDC through the Public Health Laboratory Information System (PHLIS).
• The President's Council on Food Safety identified egg safety as one component of the nation's food safety program that warranted immediate federal, interagency action. The Council developed an Egg Safety Action Plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. The Action Plan offers industry the flexibility to choose from two SE reduction strategies, each equivalent to meet the Action Plan's interim goal of a 50% reduction in egg-associated SE illnesses by 2005. http://www.cfsan.fda.gov/~dms/fs-toc.html
• FDA has implemented several measures, including the following:
  • FDA included guidance on egg safety in labeling guidelines and in two FDA draft guidelines for HACCP at retail. The first, Managing Food Safety: A Guide for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments, is targeted to operators of retail food establishments, with attention to CDC-identified risk factors and active managerial control of risks within a food service establishment. The draft guide was developed in 1998 and is available. The second guide will be available soon. http://www.cfsan.fda.gov/~dms/eggsguid.html http://www.cfsan.fda.gov/~dms/hret-toc.html
  • In December 2000, FDA published a final rule requiring that all shell eggs (except those treated to destroy Salmonella), both in interstate and intrastate commerce, bear safe handling instructions and be stored and displayed at a temperature of 45 °F or less. FDA provided industry guidance and continued to work with States and processors to implement this rule in FY 2002. FDA is predicting a 33% reduction in illnesses from SE in eggs from this rule. This builds upon the labeling and refrigeration rules which also contribute about 15% towards the risk reduction goal. http://www.cfsan.fda.gov/~lrd/hhseggs2.html
  • In 2001 FDA developed egg safety information for consumers and guidance for food service and retail operations http://www.cfsan.fda.gov/~dms/fs-eggs.html
• FSIS signed 11 new State partnership cooperative agreements in 2003 to fund food safety education projects for animal and egg producers The cooperative agreements focus on preventive measures that can be taken on the farm and cover a variety of topics including SE. The agreements are designed to provide guidance and funding to the many stakeholders, such as food animal producers, veterinarians and public health personnel, who all play a role in ensuring food safety at the production level.
• FSIS is completing an egg baseline study to establish lethality performance standards for pasteurized egg products. Data will be used in an FSIS Salmonella Enteritidis risk assessment. FSIS anticipates completion of the risk assessment in 2004.

10.3 Prevent an increase in the proportion of isolates of Salmonella species from humans and from animals at slaughter, that are resistant to antimicrobial drugs.

• Although some foodborne diseases reported to FoodNet are decreasing, the potential for serious illness increases when the bacterial pathogen is resistant to the antibiotics that are normally used to treat it. Concerns regarding the global increase in antimicrobial drug resistance have been expressed by expert scientific organizations such as the Institute of Medicine, World Health Organization and the American Society for Microbiology.
• An increasing number of infections from Salmonella species have been shown to be resistant to multiple antimicrobial agents.
• Data for objective 10.3 are obtained from the National Antimicrobial Resistance Monitoring System (NARMS). NARMS was established in 1996 in response to the concerns regarding increased antimicrobial resistance. NARMS is a collaborative program between FDA, CDC, FSIS, the Agricultural Research Service (ARS), and the Animal and Plant Health Inspection Service (APHIS) to prospectively monitor trends over time in antimicrobial susceptibilities of foodborne enteric organisms. The program is administered by the FDA Center for Veterinary Medicine (CVM).
• Funds were provided in May 1997 to increase the national surveillance for antimicrobial resistance of foodborne pathogens. The program has continued to expand to include additional sites and sources of enteric bacteria. In 2003, the sources of human isolates for NARMS have expanded to include all 50 states.

Challenges and Barriers:

• It has been demonstrated that the use of antibiotics in humans, animals, and the environment contributes to resistance development. Due to the complexity of antimicrobial drug resistance, collaboration between many diverse groups, including agriculture experts, public health experts, and regulatory agencies is required to successfully address the issue.
• NARMS began with minimal funding and has expanded over time. Due to the changes over time, there are limitations to the use and interpretation of the data, particularly for HP2010 objectives that require nationally representative prevalence data. NARMS data are descriptive in nature and are intended to identify trends that can be targeted for further scientific investigation.
• FSIS has contributed Salmonella isolates from animals to the NARMS program since 1997. However, the bulk of FSIS data are from the Salmonella HACCP compliance testing program, a regulatory program which is not statistically designed to estimate prevalence. Therefore, these data cannot be used to establish valid baselines. Although the Agency will likely conduct baseline testing of animals at slaughter in the future, neither bacterial isolates nor antimicrobial resistance data will be available in 2004 for use in the Midcourse review to establish measurable objectives for 2010. For that reason, the Food Safety Work Group has recommended that objectives 10-3e through 10-3p be dropped during the Midcourse Review.

Strategies/Opportunities: Surveillance data

• A proposed initiative that may provide valuable data for forming future Healthy People objectives is the Collaboration for Animal Health, Food Safety, and Epidemiology (CAHFSE) program. Through this initiative, FSIS, ARS and APHIS, with cooperation from industry, will coordinate their efforts to measure antimicrobial resistance from the farm to the table. The CAHFSE program may be a valuable way to measure prevalence of antimicrobial-resistant organisms in animals over time.

Strategies/Opportunities: Preventing an increase in antimicrobial resistance

Education:

• The CDC, in collaboration with the American Medical Association and medical specialties has developed and published guidelines for the prudent and judicious use of antimicrobial drugs in humans. They have also worked with Medical Schools to implement curricula for medical students on the appropriate use of antimicrobial drugs.
• A program is also being developed in conjunction with the Michigan State School of Veterinary Medicine to produce similar curricula for veterinary medical students.
• FDA/CVM has developed educational media to educate veterinarians and food animal producers regarding prudent use. These include individual pamphlets describing the judicious use of antimicrobials specifically for swine, poultry, pork, dairy cattle, and beef cattle veterinarians, as well as dairy, beef, poultry, and pork producers. In addition, a NARMS pamphlet was published that describes the problem of antimicrobial resistance and how the NARMS program works.
• CVM has worked with the American Veterinary Medical Association (AVMA) to encourage development of general veterinary antimicrobial drug use guidelines and specific guidelines by each food animal producer group.
• The FDA/CVM also worked with the AVMA and the National Pork Board to produce two videos, "Keeping Up Our Guard," for veterinarians and "Safeguarding America's Health," for livestock producers. The videos incorporate the AVMA's set of fifteen judicious use principles designed to reduce the potential threat to human health from resistant bacteria developed from the use of antimicrobial drugs in food animals. The video, "Keeping up our Guard" has been distributed to veterinary schools. It is available through the AVMA free loan video library. The video "Safeguarding America's Health" is available from CVM.

Research:

• The FDA/CVM is supporting research at Iowa State University to develop a software program for veterinarians that will guide them in the prudent and appropriate use of antimicrobial drugs in animals.
• Through NARMS funding, the CDC has supported research at the University of California and Michigan State University on the prudent use of antimicrobial drugs in dairy cattle. The University of Michigan study compared "organic" dairies that did not use antimicrobial drugs with those dairies that routinely used antimicrobial drugs. The results indicated that there was no difference in the cost to the dairy producer when no antimicrobial drugs were used. These results have been presented at veterinary and dairy producer meetings and published in peer-reviewed journals.
• Two studies on the prudent use of antimicrobial drugs in swine are ongoing at the Ohio State and Tufts Universities. 2003 was the final funding year and the studies are in the final stages. Preliminary results were presented at the NARMS Scientific Meeting held March 4-5 in Atlanta, GA.
• The three participating NARMS laboratories are conducting research into the genetic determinants of resistance. USDA Agricultural Research Service (ARS) has developed microarray technology to identify resistance determinants in Enterococcus spp. USDA ARS has also developed the PulseVet program in collaboration with CDC's PulseNet. PulseVet will conduct genetic fingerprinting of animal enteric bacterial isolates for comparison to human isolates in PulseNet. The isolates are collected as part of NARMS and other monitoring programs.

Regulatory Action:

• The FDA/CVM is currently in a regulatory action to withdraw the approval for the use of fluoroquinolones in poultry. The FDA Administrative Law Judge reviewed the proceedings and ruled that the approval should be withdrawn. The industry sponsor of enrofloxacin for use in poultry may appeal this ruling to the FDA Commissioner. This action is the result of a risk assessment conducted by FDA/CVM that determined a risk to human health from the consumption of antimicrobial resistant Campylobacter organisms found in poultry.

10-4 (Developmental) Reduce deaths from anaphylaxis caused by food allergies.

• For certain individuals, the presence of allergens in food can be life threatening. In the U.S. allergenic proteins found in the following eight foods cause an estimated 90% of allergic reactions from foods: milk, eggs, fish, wheat, tree nuts, peanuts, soybeans, and crustaceans. Currently, there is no cure for food allergy. The only successful method to manage food allergy is to avoid foods containing the allergen. Formulated foods present a separate challenge. In such cases, the individual relies on accurate ingredient labeling.⁽³⁾
• The International Classification of Diseases-10 (ICD-10) contains new codes for reporting deaths from food-induced anaphylaxis (T78.0 and T78.1). The developmental objective for anaphylactic deaths from food allergies is based on the ICD-10 classification reports through the national vital statistics system (CDC/NCHS).

Challenges and Barriers:

• 1999 is the first year ICD-10 was used and data were available. Reports from 1999 and 2000 show a significantly lower number of reports of deaths from anaphylaxis caused by food allergies than expected.
• Death certificate data do not necessarily reflect all allergen-related deaths.
• The under-reporting may be associated with unfamiliarity of medical practitioners with the use of the ICD-10 classification system and the availability of the new codes.
• Morbidity from non-fatal allergic reactions is not captured using data for deaths from anaphylaxis.
• Foods can be cross contaminated with allergens when non-dedicated equipment or production lines are used to produce both allergen-containing foods and foods that are not supposed to contain allergens.
• Manufacturers may be using labeling statements such as, "may contain" rather than improving prevention of cross contact of products.
• Avoidance of specific allergy-causing food is the only way to avoid an allergic reaction. Reading ingredient labels for all foods is the key to maintaining control over the allergy. Consumers may not understand all terms that designate the food to which they are allergic.

Strategies/Opportunities:

• FDA/CFSAN and the HP2010 Food Safety Work Group have used information from the 2001 FDA/FSIS Consumer Food Safety Survey to develop an additional sub-objective on food allergens for consideration during the Healthy People Steering Committee meeting in June 2004.
• The proposed objective is 10.4b "Reduce severe allergic reactions to food among adults who have a food allergy diagnosis." The 2001 baseline is 27% and the 2010 goal will be a 22% reduction to 21%.
• Prevention of reactions of allergic individuals to allergens in foods requires a many- pronged approach including processing without cross-contact, appropriate ingredient labeling, inspection efforts, and specific education or training of food workers, medical professionals and consumers.

Enforcement and inspection:

• FDA's Current Good Manufacturing Practices (CGMPs) regulations are requirements for protecting foods from conditions that may render the food injurious to health and cause the food product to be adulterated, including cross-contamination with food allergens in products not labeled as containing these foods or food ingredients.
• FDA developed guidance for regulators on how to perform allergen inspections and has provided training and train-the-trainer courses, as well as video courses in 2001. http://www.cfsan.fda.gov/~dms/wh-alrgy.html
• In 2003, FDA and the Association of Official Analytical Chemists - International (AOAC) collaboratively validated the performance of test kits to detect peanut proteins in breakfast cereal, cookies, ice cream and milk chocolate. FDA drafted guidance on use of these test kits. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01258.html
• FDA initiated targeted inspections of establishments for allergen/cross contamination with a pilot in 2001. In 2002 FDA performed 1653 targeted allergen inspections. Because FDA is reviewing its allergen enforcement authority allergen inspections were scaled back to 960 in 2003.
• In 1998, the FDA formed a partnership with the Minnesota Department of Agriculture and the Wisconsin Department of Agriculture, Trade and Consumer Protection in response to an increase of allergen-related recalls and concerns of controls of cross contamination of undeclared allergen residue. The goals of the Partnership were to eliminate duplicate inspection and sample collections, ensure uniform enforcement, obtain current information on allergen awareness and provide feedback on useful allergy control information and training to the food industry.

Labeling:

• FDA regulations include ingredient-labeling requirements. Advisory labeling ("may contain") cannot be used in lieu of food manufacturing practices.
• FDA has put forward guidance concerning processing food to combat undeclared allergens. A Dear Colleague letter was released and a notice of availability of FDA's Compliance Policy Guide (CPG) on Allergens, entitled "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens," was published in the Federal Register on May 3, 2001. The Dear Colleague letter is available on the Internet at http://www.cfsan.fda.gov/~dms/alrgltr2.html . The Allergen CPG is available on the Internet at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
• Congress is preparing to reintroduce an allergen-labeling bill. FDA has provided technical assistance as requested on this issue. The bill is entitled The Food Allergen Labeling and Consumer Protection Act (FALCPA). The Senate version of the bill, Title II of S. 741, was passed by the Senate, introduced in the House, and referred to the House Subcommittee on Health. The House version of the bill, HR 3684, was introduced in the House and referred to the same House Subcommittee.
• FSIS advocates the use of voluntary labeling statements by industry to alert people who have sensitivities or intolerances to the presence of specific ingredients. http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/larc/ingredients/allergens.htm
• FDA held a public meeting in 2001 to assist FDA to determine what additional actions may be necessary to provide consumers with adequate information on product labels
• FDA hosted a public workshop in 2002 on the labeling of foods containing allergens. The workshop was held to provide information about FDA food labeling regulations, allergen declaration and other related matters to the regulated industry, particularly small businesses and startups.

Education:

• CDC-Division of Adolescent and School Health is providing food allergen information through the School Action Plan.
• The Food Allergy and Anaphylaxis Network provides information for consumers and food service on food allergens.
• FDA has developed educational materials and activities for those with food allergies, for processors, retailers, preparers, and those who care for school children with allergies, i.e., parents, teachers, caregivers, child care workers, as well as for medical professionals. http://www.cfsan.fda.gov/~dms/wh-alrgy.html
• FDA/CFSAN is developing an educational program to provide information to emphasize food allergy issues with physicians and other health professionals. This program will focus on:
  • Providing information on an ongoing basis regarding FDA/CFSAN food allergy activities to physicians, other health professionals and their organizations.
  • Developing mechanisms to enhance surveillance of food allergy associated anaphylaxis and death.

10-5. Increase the proportion of consumers who follow key food safety practices.

• The key food safety practices are based on the four Fight BAC!® messages developed by the public-private Partnership for Food Safety Education in cooperation with FSIS, CDC and FDA: clean--wash hands, utensils and surfaces often; separate--don't cross-contaminate; cook--cook to proper temperatures; and, chill--refrigerate promptly.
• Estimates based on the FDA/FSIS 2001 Consumer Food Safety Survey suggest that 75.4% of consumers report food handling practices that are consistent with the four basic food safety messages, up from 73.1% in 1998. In particular, consumers reported using improved food-handling practices that reduce cross-contamination after contact with raw fish, meat, or chicken. Consumers reported an increase in thermometer use. The number of consumers eating pink hamburger, steak tartare, and raw eggs stayed relatively level. However, more people reported eating raw clams, oysters, or fish in 2001 than in 1998.

Challenges and Barriers--Data:

• The Food Safety Survey data available to measure progress toward this objective require self-reports of average behaviors across multiple and varied instances. Therefore, the measured percentage of consumers who engage in safe behavior is likely to be an overestimate. However, the change in safe practices, because they are measured in the same way over time, is likely to be realistic.
• The data collection method used to obtain data for measuring progress toward this goal, telephone surveys, has suffered from declining response rates across all types of surveys. Extraordinary efforts are required to achieve minimally acceptable response rates. This increases the field time and the cost of each data collection.
• A large sample of at least 4,500 is needed to produce statistical analysis of small demographic subgroups. This increases the cost of each data collection.

Challenges and Barriers--Consumer Practices:

• Changing people's behavior is generally difficult. In situations where most people believe they already follow the recommended behaviors, as is the case with home food safety practices, increasing compliance is especially difficult because those not in compliance are likely to be resistant to the recommended practices.

Strategies/Opportunities--Data

• Planning began in 2003 for the next Food Safety Survey data collection, planned for 2005.

Strategies/Opportunities--Consumer Practices:

• FDA and FSIS are implementing three overarching food safety education strategies to achieve the goal of 79% compliance by 2010: national education campaigns; regional and local initiatives in cooperation with Federal field personnel, State and local health departments, and health care providers; and school-based education programs.
• National partnerships are key to food safety education activities. Two prime examples of these partnerships are the Partnership for Food Safety Education, a national coalition of industry, consumer, and government groups; and the USDA/FDA Foodborne Illness Education Information Center (www.nal.usda.gov/fnic/foodborne),which provides a comprehensive database of food safety education materials produced by government, industry, academia, and others.
• FSIS and FDA utilize the following tools in educational campaigns and programs to increase consumer awareness of food safety (http://www.fsis.usda.gov/oa/background/fseducation.htm):
  • The USDA Meat and Poultry Hotline;
  • The FDA Food Information Line;
  • Media campaigns with press events, reproducible information packets and public service announcements (in Spanish and English), and follow-up media tours;
  • Educational videotapes and curricula;
  • Satellite video teleconferences, including video streaming via the Web;
  • Publications, brochures, fact sheets (in Spanish and English);
  • A quarterly newsletter titled The Food Safety Educator distributed to educators nationwide and available through the FSIS Web site;
  • The FSIS food safety mobile that was introduced in 2003;
  • A monthly electronic newsletter, EdNet, distributed to food safety educators; and
  • Web-based consumer information.

  Specific examples of food safety education campaigns include:

  • The Partnership for Food Safety Education's Fight BAC!® Campaign
  • The Food Thermometer Educational Campaign
  • National Food Safety Education Month^SM
  • Campaigns for Targeted Audiences.
• Additional examples of recent, ongoing, and planned education campaigns, including national, regional, local, and school-based programs, are included in the "Exhibits" section of this Progress Review Briefing book.

10-6 Improve food employee behaviors and food preparation practices that directly relate to foodborne illnesses in retail food and food service establishments.

• This objective is based on assessments of the occurrence of CDC-identified foodborne disease risk factors⁽⁴⁾ in retail food and food service establishments. Information gathered during data collection efforts may identify beginning patterns in compliance with specific Food Code requirements related to food preparation practices and food employee behaviors at institutional food service establishments, restaurants, and retail food stores. The 2010 goal is to reduce by 25% the occurrences of CDC-identified risk factors that cause foodborne illness in retail food and food service establishments.
• The nine types of retail food and food service establishments are: institutional food services (hospitals, nursing homes, elementary schools), restaurants (fast food, full-service), and retail food store departments (deli, meat and poultry, produce, seafood).
• The 17,477 observations collected in 1999 baseline study (Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors http://www.cfsan.fda.gov/~dms/retrsk.html ) found five practices and behaviors needing priority attention within retail food establishments. The following practices and behaviors exceeded a 40% OUT OF COMPLIANCE observation rate:
  • Cold holding of potentially hazardous food at 41°F (5°C) or below;
  • Cold holding of ready-to-eat, potentially hazardous food at 41°F (5°C) or below;
  • Date marking of commercially processed ready-to-eat, potentially hazardous food;
  • Cleaning/sanitization of surfaces/utensils; and
  • Proper, adequate hand washing.

Challenges/Barriers in assessing the occurrence of foodborne illness (FBI) risk factors and tracking trends:

• Maintaining a study design that results in comparability between FDA 1999 baseline data and data from subsequent data collection efforts. Data collection in 2003 and 2008 will result in data that begin to show patterns of change in behaviors or practices. Additional data collection beyond 2008 is needed to begin to identify and track trends. In essence, maintaining a measurement tool that we could repeat on a cyclical basis to see what changes have occurred;
• Recognizing limitations associated with data derived from observations made at a single inspection of each food establishment.

Challenges/Barriers in improving food employee behaviors and food preparation practices (reducing the occurrences of foodborne illness (FBI) risk factors) within retail food establishments:

• Training this high-turnover job force is a major challenge. The retail level food and food service workforce is diverse, multi-lingual, and has various cultural practices.
• Another challenge is in applying the knowledge obtained through food worker training courses to achieving real behavior change in the retail food and food service establishment. Changing people's behavior is generally difficult.
• Responsibility for establishing and enforcing retail food safety regulations is splintered across thousands of regulatory agencies with differing priorities.

Strategies/Opportunities (Assessment):

• The FDA, National Retail Food Program Team collected data in 2003 and plans data collections by FDA personnel in 2008. Data collected in 2003 are being analyzed now with a report to be released in September 2004 and a satellite broadcast scheduled for October 14, 2004.

Strategies/Opportunities (Behaviors and Practices):

• Strategy chosen - to track trends in the occurrence of FBI risk factors rather than illnesses - Although identifying the level of foodborne illnesses would be the ideal, the occurrence of foodborne illness is grossly underreported, making it an unreliable program measurement. As an alternative, the occurrence of FBI risk factors was selected as the performance indicator.
• Encourage State and local regulatory agencies to focus on Food Code interventions and strategies under the Draft National Voluntary Retail Food Regulatory Program Standards⁽⁵⁾. State and local regulatory jurisdictions use of the Program Standards allows for the development of community-based baselines by States and local jurisdictions under Standard #9. Regulatory agencies may wish to use the FDA model or customize their baselines to address specific needs or concerns within their jurisdictions.
• Follow the FDA Retail Food Program Operational Plan for long term goals for the national program as well as GPRA measurement of the successful implementation of program objectives.
• Enhance industry focus on Food Code interventions and attention to active managerial control of key risk factors through broad application of the Program Standards improved training materials and courses, and public educational campaigns.
• The Food Safety Training and Education Alliance for Retail, Food Service, Vending, Institutions, and Regulators (FSTEA) is a partnership of industry, consumer, trade, Federal, State and local food protection agencies to improve and promote food safety education for food service personnel and food safety regulators and increase implementation of the Food Code. See www.fstea.org
• To reduce the incidence of foodborne illness associated with eggs, FDA prepared a brochure and poster on safe handling of eggs and egg-containing menu items, which has been distributed widely to State regulatory and health agencies and mailed directly to more than 70,000 food service managers. Spanish and Chinese versions of the brochure and poster are available.
• The FSIS Thermy™ campaign expanded to food service (institutional settings) in 2002. Thermy™ is the messenger of a national consumer education campaign designed to promote the use of food thermometers. The time/temperature recommendations are based on the FDA Food Code 2001. Thermy™ magnets and posters were developed and distributed. Thermy™ campaign products are available in English and Spanish versions. See http://www.fsis.usda.gov/thermy/index.htm.
• FSIS, FDA and CDC have been part of a task force with the International Association for Food Protection's Retail Food Safety and Quality Professional Development Group (IAFP) to develop10 international food safety icons. These icons or symbols depict ten different food safety concepts for use as communication and education/training tools in the culturally diverse workforce in the foodservice industry and are now available. (See Exhibits section of this Briefing Book.)

10-7. (Developmental) Reduce human exposure to organophosphate pesticides from food.

• The Food Quality Protection Act of 1996 mandated that the Environmental Protection Agency (EPA) reassess existing standards for pesticides used on food crops. 0rganophosphates, a group of approximately 40 closely related pesticides, have been designated as first priority in the standards reassessment. These pesticides are used on fruits and vegetables important in the diets of children.

Challenges and Barriers:

• Organophosphates were used on many food crops and accounted for about half the amount of insecticides used in the US at the time Food Quality Protection Act (FQPA) was implemented.

Strategies/Opportunities:

• The EPA reassessment of organophosphates resulted in cancellation of a number of uses of these pesticides.
• Levels of pesticide residues in foods are monitored annually through FDA's Total Diet Study (TDS). It was expected that results of the TDS would demonstrate a gradual decrease in the number and levels of organophosphate pesticides in foods over the period relevant to the Healthy People 2010 (1997-2010).
• A recent review of the TDS results for organophosphates for the period 1997-99 indicated very few detectable levels of organophosphate residues in foods. In addition, the levels detected in these samples were extremely low.
• It is expected that the TDS will demonstrate even fewer findings in subsequent years. With such low levels and so few findings each year, it would not be possible to demonstrate a decreasing trend in the presence of organophosphate residues in TDS samples. For this reason, the working group will recommend during the Midcourse Review that this objective be excluded.
• The proposed measure was to be based on a calculation of human exposure from food consumption data and pesticide residue data (TDS). The CDC/National Center for Environmental Health Second National Report on Human Exposure to Environmental Chemicals, released on January 31, 2003, will provide a more direct measure of exposure/body burden through biomonitoring. Biomonitoring is the assessment of human exposure to chemicals by measuring the chemicals or their metabolites in human specimens such as blood or urine.
• Refer to related objectives 8-24a-d in the Environmental Health Focus Area for data on exposure to four pesticides. (These data are included in the Data Tables section of the briefing materials.)

Related Objectives from Other Focus Areas

1. 8. Environmental Health
2. 8-5. Safe drinking water
3. 8-6. Waterborne disease outbreaks
4. 8-8. Surface water health risks
5. 8-10. Fish contamination
6. 8-24. Exposure to pesticides
7. 8-25. Exposure to heavy metals and other toxic chemicals
8. 8-29. Global burden of disease
9. 8-30. Water quality in the U.S.-Mexico border region
10. 14. Immunization and Infectious Diseases
11. 14-21. Antimicrobial use in intensive care units
12. 20. Occupational Safety and Health
13. 20-8. Occupational skin diseases or disorders
14. 23. Public Health Infrastructure
15. 23-2. Public access to information and surveillance data

Hypertext updated by ear June 9, 2004