Healthy People 2010 Progress Review: 2007 Challenges, Barriers, Strategies, and Opportunities

December 12, 2007  

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


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 annually to foodborne pathogens[1].  Yet, many people rarely think about food safety until a foodborne illness affects them or their family.  The Food Safety Focus Area seeks to decrease the rates of diseases caused by microorganisms transmitted mainly by food, such as Salmonella, Campylobacter, and Escherichia coli O157:H7. Specific objectives support tracking new and total cases of the most common foodborne diseases and  making food safety education a primary area of emphasis.

As a result of effective collaborations of Federal, State, local and international food safety partners with industry, consumers, and academia, the American food supply continues to be among the safest in the world.  Data from the Foodborne Diseases Active Surveillance Network (FoodNet) clearly show that the preventive measures being implemented by the Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), and others are achieving significant public health outcomes in the effort to reduce the incidence of foodborne illness.  In recent years, we have done a great deal to protect the food supply from unintentional and deliberate contamination.  Research is ongoing and is leading us to continued reductions in foodborne disease and allergic reactions.  We have made significant progress, but we will continue to strive to reduce the incidence of foodborne illness to the lowest level possible.  To that end, this Healthy People 2010 Focus Area Data Progress Review is intended to examine challenges, barriers, strategies, and opportunities associated with foodborne illness, and includes initiatives that have been undertaken through August 2007.

Important very recent accomplishments are described in the Addendum[2] and include the October 2007 FSIS announcement of new and ongoing actions to protect public health against the risk of Escherichia coli O157:H7[3] [4], the November 11, 2007 signing of the Import Safety Action Plan[5] to improve the safety of imports entering the United States, the issuance of FDA’s Food Protection Plan[6], and the December 11, 2007 signing of the U.S. DHHS-China Agreement on Food and Feed Safety[7]. The Food Protection Plan uses science and a risk-based approach of prevention, intervention and response to ensure the safety of domestic as well as imported foods.  The China Agreement establishes a bilateral cooperative mechanism to prevent, intervene, and respond to any safety issues related to food and feed exported from one country to the other.   

Health Disparities

The Food Safety Focus Area also examines health disparities among segments of the population.  Once inequities are identified, work can begin on their correction. 

Challenges and Barriers:

Representative data on specific U.S. populations by race, ethnicity, gender, and education are limited.  Despite limited data, overall, non-Hispanic white population, females, and high school graduates had reduced rates for foodborne illness and safer food preparation practices.  According to the preliminary data available, disparities among select racial and ethnic populations exist.

Strategies and Opportunities:

  • While disparities exist among select racial and ethnic populations, it should be noted that the very young, elderly, and immunocompromised persons experience the most serious foodborne illnesses.  With continued tracking of these differences in foodborne illness and safer food preparation practices, educational initiatives can better target the populations in need.    

Foodborne Pathogens

Note: Challenges, barriers, strategies, and opportunities relating to objectives 10-1 and 10-2 will be addressed together in this report.

10.1 Reduce infections caused by key foodborne pathogens.
10.1a Campylobacter species
10.1b Escherichia coli O157:H7
10.1c Listeria monocytogenes
10.1d Salmonella species
10.1e Cyclospora cayetanensis--Subobjective was deleted due to very low incidence and variable annual occurrence
10.1f Postdiarrheal hemolytic uremic syndrome (HUS) in children less than 5 years of age
10.1g Congenital Toxoplasma gondii--Subobjective was deleted due to lack of data source  

10.2 Reduce outbreaks of infections caused by key foodborne bacteria.
10.2a Escherichia coli O157: H7
10.2b Salmonella serotype Enteritidis

Data for objective 10.1 are from FoodNet, an active, population-based surveillance system designed to determine more precisely the burden and severity of foodborne illnesses and identify the sources of specific foodborne diseases.  Established in 1996, FoodNet is a collaborative activity of the CDC, FDA, FSIS, and 10 States (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee).  The FoodNet surveillance population increased from 14.2 million persons (5% of the U.S. population) in five States in 1996 to 44.5 million persons (15% of the U.S. population) in 10 States in 2005.

Data for objective 10.2 are from the Electronic Foodborne Outbreak Reporting System (eFORS)eFORS is CDC's internet-based system designed for State health departments to report foodborne disease outbreaks.

Declines in disease and contamination are indicative of the important progress toward the Healthy People 2010 objectives.  In 2007, CDC reported decreases in the incidence of infections caused by Yersinia (50% reduction), Shigella (35% reduction), Listeria (32% reduction), Campylobacter (30% reduction) after comparing data obtained in 2006 with baseline data obtained in 1996-1998.  Incidence of infections caused by Vibrio infections did increase however and Shiga toxin-producing E. coli O157:H7 (STEC O157), Crytosporidium and Salmonella did not change significantly compared with baseline[8]. Regulatory sampling of raw ground beef product by FSIS for E. coli O157:H7 demonstrated a sharp decline in the prevalence rate from calendar years 2001 to 2006.  Of 7,010 samples, there were 59 positives (0.8%) in 2001.  Of 11,799 samples, there were 20 positives (less than 0.2%) in 2006[9].  Similarly for Listeria monocytogenes (L. monocytogenes) FSIS regulatory sampling in ready-to-eat (RTE) products showed a decline from 3.02% positive in 1995 to 0.61% positive in 2006[10].  

In addition, regulatory sampling by FSIS at slaughter and processing plants demonstrated declines in Salmonella contamination of ground beef and beef carcasses since 1998, but indicated a sustained increase in chicken broiler carcasses testing positive for Salmonella during 2002-2005.  FSIS announced a major Salmonella initiative in February 2006 that included several components including focusing testing on the establishments having the most difficulty controlling Salmonella, informing establishments after finding serotypes of the greatest public health concern, and initiating testing of turkey carcasses using a performance guideline.  Following this initiative, the percentage of positive samples for broilers dropped to 11.4% in 2006 following a high of 16.3 % in 2005.  The 2006 results for turkeys were 7.1% compared to the 1997-1998 baseline level of 19.6 %[11]

Challenges and Barriers:

  • The extent of foodborne illness is difficult to assess and finding ways to more precisely estimate the total burden on the U.S. population is a challenge.
  • Only a fraction of foodborne illnesses are reported to CDC because a complex chain of events must occur before a foodborne infection is reported.  The FoodNet 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.
  • The majority of foodborne illnesses are sporadic; only a small number are identified as being part of an outbreak and reported through eFORS.
  • It is difficult in individual cases to define a source (e.g., attribute the illness to a specific food, water, or person-to-person contact) of pathogens that cause gastrointestinal illness, or to determine where in the food chain the contamination originated.  Such determinations are conducted in outbreak investigations.
  • The FoodNet data are limited to foodborne diseases caused by bacteria and two parasites and does not include viruses or other pathogens.  Viruses are considered to be the major cause of foodborne illness.  Bacteria usually cause more severe illness compared with viruses and 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 some species of Salmonella species and by Vibrio species.    FoodNet annual reports, which include summaries of information collected through active surveillance of nine pathogens, may be found at:
  • Although Salmonella incidence did not decrease significantly overall, the incidence of S. Typhimurium decreased significantly (41%).  In contrast, significant increases in incidence compared with baseline occurred for S. Enteritidis (28%), S. Newport (42%) and S. Javiana (92%). The estimated incidence of S. Heidelberg and S. Montevideo did not change significantly compared with baseline8.
  • Further investigation is needed to identify sources for emerging Salmonella serotypes such as Salmonella Javiana and I4,[5],12:i:-, a monophasic serotype resembling Salmonella Typhimurium that has previously been misclassified as Group B Salmonella or Salmonella Typhimurium8.
  • Identification of risk factors of foodborne illnesses in infants, children, and the elderly is needed to enable us to reduce the high incidence of these illnesses in these populations.
  • RTE (ready-to-eat) fresh vegetables, fruits, and prepared salads have a high potential risk of contamination because they are generally grown in a natural environment such as a field or orchard and are often consumed without cooking or other treatments that could eliminate pathogens if they are present.  Illnesses caused by E. coli O157:H7, Salmonella species, and the Hepatitis A virus are continuing concerns for fresh produce. 

Strategies and Opportunities:

Foodborne illness surveillance information is used to determine what additional food safety strategies are needed in research, inspections, surveillance, and standards, for education, and in the design of the strategies to decrease the number of cases and also the number and size of foodborne illness outbreaks.  Surveillance information is also used to measure the effectiveness of interventions over time.  FDA and FSIS coordinate with key Federal, tribal and State partners, including CDC and State governments.  For example, FDA has developed and implemented prevention strategies for seafood, juice, fresh fruits and vegetables, sprouts, and shell eggs.  FDA has focused recent prevention strategies on leafy greens, tomatoes, and cantaloupe[12].  FSIS has developed and implemented prevention strategies for meat, poultry, and processed egg products.  Inspection and food safety enhancements implemented by FSIS and the industry have reduced by half the number of recalls of meat, poultry, and processed egg products during the last four years.  In 2002, FSIS reported 129 recalls.  By contrast, in 2006, the Agency reported only 34 recalls[13].

In February 2007, FSIS announced a proposed timetable for introducing a more robust risk-based inspection (RBI) system in processing plants.  As part of a strategy to place resources where the greatest need exists, FSIS intends to assess relative risk of what each processing plant produces and how each plant is controlling risk in its operations.  This will allow the Agency to more effectively allocate inspection resources while continuing daily inspection at all processing facilities.  This enhanced inspection system will be more proactive in terms of preventing human illness and will yield greater confidence that meat, poultry, and egg products are safe.  FSIS and FDA have also worked with stakeholders at public meetings to find ways to reduce food safety hazards. 


Surveillance systems, both passive and active, alert States, CDC, FDA, and FSIS to cases and increases in foodborne illness.  Disease surveillance and epidemiological investigations provide information to use in outbreak investigations 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.  Some of the ongoing surveillance systems include:

  • CaliciNet "fingerprints" strains of Calicivirus (includes Noroviruses, previously named "Norwalk-like viruses") that may cause foodborne outbreaks.
  • eFORS, the internet-based system, is making the reporting of data more timely and anticipates providing data more quickly on a routine basis.  The CDC has created a questionnaire intended for use as a template for investigating foodborne disease outbreaks.  The questionnaire may be found at:
  • EHS-Net is a collaborative effort of CDC's National Center for Environmental Health (Environmental Health Services Branch), FoodNet, and FDA. EHS-Net refines data on retail food service-associated outbreaks with the goal of helping CDC, FDA, and the States evaluate Food Code issues.
  • eLEXNET, the electronic Laboratory Exchange Network, is a network that allows health officials engaged in food safety activities to compare, share, and coordinate laboratory analysis findings on food products from Federal (FDA, USDA, and Department of Defense), State, and local food safety laboratories.  One hundred laboratories representing all 50 States are participating in eLEXNET, and there is interest from international laboratories in possible participation.
  • FoodNet, the Foodborne Illness Active Surveillance Network, is exploring statistical/epidemiologic methodologies to more precisely determine the burden of foodborne illnesses in the U.S. population.
  • ORST, the CDC Outbreak Response and Surveillance Team, provides guidance to public health investigations of foodborne outbreaks and provides standard questionnaires. 
  • 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) and has been useful in identifying cases linked to outbreaks.  PulseNet is rapidly becoming international with programs on all continents.
  • VetNet is a USDA system modeled after PulseNet to conduct PFGE analysis of Salmonella species isolates from food animals.  It uses comparative data to assist in surveillance and study of the ecology of organisms along the food chain and investigate animal and foodborne illness outbreaks.

Regulation, Guidance, Enforcement

FDA and FSIS have implemented the Hazard Analysis and Critical Control Point (HACCP) system regulations for seafood (1997), meat and poultry (1998–2000), 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.

Congress directed schools that participate in the School Meal Programs to adopt a more vigilant approach to food safety by requiring two new food safety provisions:  an increase in the required number of food safety inspections from one to two a year, and the requirement for school food authorities to implement HACCP as a food safety program for the preparation and service of meals, by July 1, 2005.[14]  The USDA Food and Nutrition Service (FNS) is responsible for guiding program operators in implementing the provisions of the requirements.  Memos, technical assistance, and guidance materials are available on the FNS Web site at

Additionally, FDA provides regulatory oversight and guidance through: 

  • The Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP).  These are general regulations that apply to all foods FDA regulates.  In addition, there are specific CGMP regulations that apply to specific food categories.
  • Regulatory programs for retail establishments, milk and shellfish involve a cooperative effort among FDA, States, and the industry to regulate the production or harvesting of milk and shellfish and the sale, preparation, and service of all foods going directly to consumers through retail-level food establishments.
    • More than 3,000 state, local and tribal agencies have primary responsibility to regulate the retail food and foodservice industries in the United States. They are responsible for the inspection and oversight of over 1 million food establishments - restaurants and grocery stores, as well as vending machines, cafeterias, and other outlets in health-care facilities, schools, and correctional facilities.  FDA strives to promote the application of science-based food safety principles in retail and foodservice settings to minimize the incidence of foodborne illness.  FDA assists regulatory agencies and the industries they regulate by providing a model Food Code, scientifically-based guidance, training, program evaluation, and technical assistance.
    • The Conference for Food Protection provides a representative and equitable partnership among regulators, industry, academia, professional organizations and consumers to identify problems, formulate recommendations, and develop and implement practices that ensure food safety.  The Conference meets biennially to consider food safety issues and recommendations to be incorporated into the FDA Model Food Code and offered for adoption by regulatory agencies to help establish nationwide uniformity.
  • Inspection and sampling.
    • Surveillance samples are those 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.
  • Guidance, as well as specific technical assistance is provided to producers (growers), processors, the States, and other countries, and is available in hard copy and through internet access:
    • Guidelines 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,"
    • The FDA Food Code (for retail level establishments as well as specific technical assistance is provided to producers (growers), processors, the States, and other countries.
  • Investigation teams:  For example, CalFERT, the California Food Emergency Response Team, a joint State of California and FDA response team was formed to investigate the source of individual foodborne outbreaks and determine the extent of possibly contaminated product.  CalFERT played a major role in investigating the sources of recent E. coli O157:H7 outbreaks from leafy greens in that State.

FSIS provides regulatory oversight through inspection regulations, compliance guidelines, and education and outreach to producers and processors of meat, poultry, and egg products: 

  • Inspection Program Enhancements
    • FSIS inspection program personnel conduct daily carcass-by-carcass inspection in meat and poultry slaughter facilities.  On July 25, 1996, FSIS published its Pathogen Reduction/HACCP rule, in the Federal Register.  Under the HACCP rule, industry is responsible for assessing potential food safety hazards and systematically preventing and controlling those hazards.  FSIS is responsible for verifying that establishments’ HACCP systems are working and that they prevent adulterated meat and poultry products from entering commerce. FSIS started updating the generic HACCP models in February 2005 to include new and pertinent regulations and policies, and to make the material more easily comprehensible to small and very small establishments. 
    • In February 2006, FSIS published the Federal Register Notice [Docket No. 04-026N] Salmonella Verification Sample Result Reporting: Agency Policy and Use in Public Health Protection.  FSIS outlined 11 initiatives designed to reverse the upward trend of positive Salmonella verification testing results. The initiatives included testing turkey carcasses and implementing a risk-based verification sampling program.  In addition, FSIS is providing establishments with their individual Salmonella test results including serotype information as it becomes available to encourage establishments to react to real-time data and make changes as necessary to their food safety systems to improve process control.  The new initiatives appeared to have an impact in reducing positive Salmonella results in broilers for 2006.
    • In 2006, FSIS issued a notice reiterating the verification activities its inspection program personnel are to perform regarding E. coli O157:H7.  In each of the last three years, FSIS has found that 0.17% of the raw ground beef samples tested by the Agency were positive for E. coli O157:H7. 9  FSIS has a performance measure aimed at keeping the percentage of ground beef positives below 0.20% and is closely monitoring the 2007 results.
    • FSIS has begun a series of nationwide baseline studies to help determine the levels of various pathogenic microorganisms in raw meat and poultry products. The microbiological data obtained from these studies will be used in the development of risk assessments, risk-based sampling programs, and/or regulatory policy decisions. See
  • Guidance and Outreach
    • HACCP was implemented in small meat and poultry plants in 1999 and in very small plants in 2000.  While larger plants implementing HACCP in 1998 required modest assistance, FSIS recognized that small and very small plants would need additional guidance and assistance.  To meet the needs of the owners and operators of small and very small plants, several outreach programs have been established and implemented.  See
    • In 2003, before the implementation of the L. monocytogenes final rule, FSIS conducted workshops in several locations throughout the country in order to discuss and explain the requirements of the rule and to answer questions from stakeholders. FSIS developed compliance guidelines and question-and-answer documents to help establishments, especially small and very small establishments, comply with the rule. The guidelines include control measures for L. monocytogenes in the post-lethality environment.
    • FSIS has made available guidance on minimizing the risk of E. coli O157:H7 and Salmonella at beef slaughter establishments, beef grinders, and suppliers of boneless beef and trim.  See
    • In 2004, FSIS provided compliance guidelines to processing establishments for controlling Salmonella in the processing of jerky.  FSIS expects to update the guidelines for controlling Salmonella in all RTE products soon.
    • In 2005, FSIS funded more than $2.5 million in cooperative agreements.  Much of the outreach to producers is carried out through cooperative agreements with academic institutions, non-profit institutions, and Federal and State government agencies.  Work products developed under these cooperative agreements are available for public use nationwide.

Education and Training

Safe food preparation and safe 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.

  • Diagnosis and Management of Foodborne Illnesses, a Primer for Physicians and Other Healthcare Professionals, was released in April 2004 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: Clean, Separate, Cook, and Chill.  The Primer, initially introduced in 2001, contains five new sections on new and re-emerging foodborne illnesses and was written with an emphasis on the vulnerabilities that exist in the post 9-11 environment.  A press release announcing the Primer may be found at:  Healthcare professionals can request free copies from the FDA, or access the Primer online at:
  • The Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (also known as the Bad Bug Book) from FDA, CDC, FSIS, and the National Institutes of Health, brings together in one place basic facts on foodborne agents.  The material has been updated with new scientific information or links to foodborne outbreak reports.  It may be found at:
  • FSIS, FDA, CDC, FNS, the USDA’s Cooperative State Research, Education and Extension Service (CSREES), and the NSF International sponsored the 2006 Food Safety Education Conference, Reaching At-Risk Audiences and Today's Other Food Safety Challenges, in Denver, Colorado, in September 2006.  The conference provided educators, communicators, medical and public health professionals, and food industry representatives with information, research, and insights on reducing foodborne illness in the general and at-risk populations in particular.  Presentations focused on surveillance and epidemiological insights about foodborne illness; food safety behavioral and attitudinal research; social marketing, educational interventions, and program research; the role of foodservice and food industries; and new technologies.
  • All existing and new FSIS inspection program personnel are currently completing the Food Safety Regulatory Essentials (FSRE) inspector training program along with other more specialized training programs such as FSRE for shelf stable products, Public Health Veterinarian training, and Enforcement, Investigations and Analysis Officer training where applicable.  These training programs teach FSIS inspection program personnel how to conduct their daily inspection activities to protect public health.
  • Educational programs and information for consumers are strategies described on page 24 of this document and are meant to improve consumer food preparation practices (Objective 10-5).  Examples of recent, ongoing, and planned education campaigns, including national, regional, local, and school-based programs, are also included in this document.

Research and Technology Transfer

FDA, FSIS, and others have developed microbiological risk assessments on particular organisms (Salmonella species, L. monocytogenes, Vibrio parahaemolyticus, Vibrio vulnificus, E. coli O157:H7, bovine spongiform encephalopathy, and Clostridium perfringens) with the goal of identifying and focusing prevention efforts on the riskiest products, procedures, and steps in the farm-to-fork continuum For example, in December 2006, FSIS completed an initial version of its risk assessment for highly pathogenic avian influenza (HPAI) associated with poultry and eggs.  This quantitative food safety microbial risk assessment is farm-to-table in scope and utilizes various scenarios to evaluate the effectiveness of emergency response strategies.  The assessment also measures the public health impact from foodborne routes of exposure to HPAI in the United States. FSIS risk assessors in collaboration with CFSAN and the Animal and Plant Health Inspection System (APHIS) initiated this assessment in September 2006. This risk assessment can be used as a tool to better understand potential exposure and mitigation strategies and will allow FSIS to work closely with industry and consumer groups to develop a robust preventive system to lessen the foodborne health risks associated with HPAI. 

  • FDA conducts and participates in research to lower the incidence of and to detect and identify foodborne pathogens.
  • CFSAN has operated a competitive (also known as 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.
  • CSREES funds food safety research in the area of food safety, particularly emphasizing the detection, prevention, and control of foodborne disease-causing microorganisms and naturally occurring toxicants.  Food safety grant programs include Ensuring Food Safety and Epidemiological Approaches for Food Safety.  Information about grant programs and funding opportunities may be found at:
  • The USDA’s Agricultural Research Service’s (ARS) 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 Federal agencies, in particular, FSIS and CFSAN.  See
  • 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.  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 the participation of State, academic, and research institutions to work cooperatively in identifying, developing, and validating new technologies that are economically viable for small and very small meat, poultry, or egg product plants to help them meet food safety requirements.  See
  • In July 2003, FSIS released a food safety vision document, Enhancing Public Health: Strategies for the Future, outlining several key initiatives the Agency is implementing to enhance meat and poultry safety and improve food inspection systems.
  • ARS, APHIS, and FSIS are working jointly on the Collaboration in Animal Health and Food Safety Epidemiology (CAHFSE) project.  CAHFSE is a surveillance project designed to enhance overall understanding of bacteria that pose a food-safety risk by monitoring these bacteria on-farm and in-plant over time and to provide a means to routinely monitor critical diseases in food-animal production.  A particular emphasis of CAHFSE is to address issues related to bacteria that are resistant to antibiotics.

Addressing 10.1 c:  FSIS and FDA Listeria monocytogenes initiatives.

Controlling Listeria monocytogenes in Ready-to-Eat Foods

  • In 2001, FSIS published the proposed rule, Performance Standards for the Production of Processed Meat and Poultry Products.  This proposed rule included log reduction requirements for processing RTE meat and poultry products with accompanying time/temperature tables for cooking in the compliance guidelines, and establishment testing of food contact surfaces for Listeria species.
  • In February 2003, FSIS held a public meeting on the draft risk assessment for L. monocytogenes in deli meat, and released the completed draft risk assessment in May 2003.
  • In June 2003, FSIS published the interim final rule, Control of L. monocytogenes in Ready-to-Eat Meat and Poultry Products.  Compliance guidelines, and questions and answers for the interim final rule were posted on the FSIS Web site.  The rule gave establishments a choice from three alternatives for controlling L. monocytogenes in the post-lethality environment.
  • In September 2003, FSIS and FDA jointly published the Final Assessment of the Relative Risk to Public Health from Foodborne L. monocytogenes Among Selected Categories of RTE Foods.
  • In September 2004, FSIS provided Form 10,240-1, a survey form for establishments producing post-lethality exposed products to determine their annual production volume and control programs.  The information from this survey form is being used to develop the risk algorithm for the risk-based verification program for L. monocytogenes.
  • In 2004, FSIS provided compliance guidelines to processing establishments for controlling L. monocytogenes in processing facilities.
  • In 2005, FSIS started risk-based verification program for L. monocytogenes.  Establishments were sampled based on the production of high risk products.
  • In 2006, FSIS issued directives 10,240.4 and 10,240.5. Under these directives, establishments are selected based on a risk-ranking model.  Products, environmental, and food-contact surfaces are sampled.  Risk-based verification was in full implementation using a risk algorithm to determine establishments’ risk ranking.
  • FSIS is conducting a risk assessment to evaluate the comparative risk presented by L. monocytogenes in deli meat from different slicing and packaging environments, i.e., in a federally inspected processing establishment and in a retail food facility.  This assessment will consider how contamination introduced into meat and poultry products during distribution and retail storage and handling may be mitigated.  This risk assessment builds off the FDA-FSIS risk assessment published in September 2003.

Guidance for Manufacturers and Retail Establishments:

  • FDA is developing and revising guidance for processors that manufacture or prepare ready-to-eat foods and for retail and food service and institutional establishments.  FDA developed and issued guidance on enhancing the safety of the production of fresh-cut produce.  One of the organisms of concern mentioned was Listeria monocytogenes.
  • FDA, in cooperation with Michigan State University, will continue to examine the levels of L. monocytogenes transferred in retail food establishments.  Specifically, the project is to study transfer rates between foods contaminated with L. monocytogenes and food contact surfaces (i.e., slicing machines, knives, spoons, etc.).  This was a grant awarded through the CFSAN's collaborative grant process in 2002 for strategies at retail.  
  • The 2002-2004 Conference for Food Protection (CFP) Date-marking Committee compiled a list of Food Code sections that pertain to L. monocytogenes control.  The Committee is developing a guidance document detailing the use of targeted sanitation procedures to assist in the control of L. monocytogenes.  
  • At their 2004 meeting the CFP accepted two HACCP guidance documents developed by FDA and reviewed by the CFP HACCP Committee.  These two guides outline the identification and control of risk factors by industry operators and the use of risk-based inspections by regulators.  Many of the intervention strategies outlined in the guides pertain to the control of L. monocytogenes.  The guides have been widely disseminated to state and local regulatory officials and industry.
  • FDA issued a Federal Register Notice on March 4, 2005 requesting data and information from the retail and foodservice industry, such as the levels of L. monocytogenes in products and in the processing plant environment, impact of time and temperature of growth of L. monocytogenes, impact of short and long term refrigeration storage, and efficacy of cleaning procedures, sanitizing agents and inhibitors.
  • FDA representatives worked with the Association of Food and Drug Officials (AFDO), the University of Florida, and Florida A&M University to develop guidance for food processing at retail. These guidance documents have been finalized and released. The draft guidance documents were specifically reviewed to assess the risk of L. monocytogenes and the organism was identified as a hazard in a number of these guidance documents (e.g., Smoked Seafood, Cured and Hot Smoked Sausage).
  • L. monocytogenes guidance for dairy plants is under development at CFSAN.
  • FDA/CFSAN is developing guidance on theControl of L. monocytogenes in Refrigerated Ready-To-Eat Foods.
  • FDA developed and delivered training and technical assistance for industry and food safety regulatory employees:  Listeria monocytogenes Preventative Controls for Regulators, a satellite course.

Enhanced Consumer and Health Care Provider Information and Education Efforts:

  • Educational programs about the risks of listeriosis have taken place through the media, health professional organizations, contacts with authors of books on pregnancy, and educational programs for special at-risk groups including seniors and pregnant women. CFSAN has participated in a program of health fairs utilizing Hispanic radio and television and Wal-Mart. Health messages on the risk of listeriosis are delivered over the Spanish language radio and television programs and information is distributed at health fairs at Wal-Mart locations in Hispanic areas. A further specialized campaign targeted to the Latino community on the concerns of queso fresco cheese was launched in the spring of 2005. The program utilizes the Hispanic media and community outreach workers (promotoras) to get the message out. A public health educational campaign by the public-private Partnership for Food Safety Education is underway to advise consumers to keep their refrigerators at 40 degrees Fahrenheit to prevent foodborne illness, including listeriosis. Information has been released through the media and is also being disseminated through grocery stores where refrigerator thermometers are promoted.

Review, Redirection, and Revision of Enforcement and Regulatory Strategies Including Microbial Product Sampling and Analytical Methods:

  • National Advisory Committee on Microbiological Criteria for Foods (NACMCF) adopted these two documents on August 27, 2004 - 1) Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods of Pasteurization and 2) Considerations for Establishing Safety-Based Consume-By Date Labels for Refrigerated Ready-to-Eat Foods.
  • On December 24, 2003, Hogan & Hartson L.L.P filed a Citizens' Petition on behalf of a coalition of fifteen leading trade associations pursuant to sections 402(a)(1) and 701(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and 21 C.F.R. § 109.4. The Petition requested that FDA amend 21 C.F.R. Part 109 to establish a regulatory limit for Listeria monocytogenes of 100 colony forming units per gram (CFU/g) in foods that do not support growth of the microorganism. On May 24, 2004, FDA published a notice the Federal Register announcing the availability of the Petition and requested comments until August 9, 2004. The Agency is now in the process of responding to the Citizens' Petition.

Enhanced Disease Surveillance and Outbreak Response:

  • Food and environmental bacterial pathogens, including L. monocytogenes, are subtyped and characterized using pulsed-field gel electrophoresis (PFGE) by FDA and FSIS laboratories and the molecular patterns are submitted to PulseNet. These patterns are routinely compared to the PulseNet database that primarily consists of patterns from clinical isolates. Patterns from the food and clinical isolates that "match" suggest a potential link and are further investigated to determine if there is an epidemiological association in a foodborne outbreak.
  • FDA CFSAN routinely monitors the PulseNet listserv as a possible early alert to a foodborne outbreak.  FDA CFSAN and FDA's ORA are more actively conducting follow-up investigations when there is a match between a food and clinical PFGE pattern involving single cases of listeriosis to determine if there is an epidemiological link  with an FDA regulated product.
  • FDA CFSAN, USDA FSIS and APHIS all have staff located at CDC's Food Safety office in Atlanta, Georgia.  This on-site relationship facilitates communication and provides early alerts to foodborne outbreaks involving regulated products.
  • FoodNet has tested and implemented a new L. monocytogenes surveillance form which is applied to each case of L. monocytogenes occurring in FoodNet sites.  Information on the form obtained in prospective interviews includes food consumption histories.  This information is used to help rapidly identify food vehicles in L. monocytogenes outbreaks detected through PulseNet.  Many states other than FoodNet sites are also using this new surveillance form.

Coordinating Research Activities to Refine the L. monocytogenes Risk Assessment, Enhance Preventative Controls, and Support Regulatory, Enforcement, and Educational Activities.

  • The L. monocytogenes risk assessment is used to focus L. monocytogenes coverage in on high risk products.
  • Of the 57 Mexican personal cheese importations tested from September 2 to October 2, 2003 during an FDA blitz at the Mexican border; 39(68%) of the 57 were determined to be made from raw milk, 32(56%) of the 57 were positive for generic Escherichia coli, 32(56%) of the 57 were positive for Staphylococcus aureus, 7(12%) of the 57 were positive for Salmonella spp., and 5(8%) of the 57 were positive for L. monocytogenes.  All isolations were confirmed by FDA laboratory analysis.
  • Docket No. 2005N-0065. Published 3-4-05. Notice for request for comments and for scientific data and information concerning foodborne Listeria monocytogenes in smoked finfish, and evaluation of Food Code provisions that address preventive controls for Lm in retail and foodservice establishments. Submitted comments are in review at FDA/CFSAN.
  • CFSAN is conducting Microbiological Research for Support of Provisions of the U.S. Food Code. This includes the growth of L. monocytogenes in ready to eat (RTE) deli salads and verification of instantaneous cook temperatures recommended in the U.S. Food Code.
  • Two research projects are being conducted at CFSAN. The first will help explain the behavioral interactivity between spoilage flora and L. monocytogenes.  The second will assist in the understanding of L. monocytogenes as it relates to the modified atmosphere packaging area.
  • Current L. monocytogenes research at FDA's National Center for Food Safety and Technology (NCFST):  Recovery of L. monocytogenes from environmental swabs (transport media).  Same day identification of L. monocytogenes using Pathatrix separation and concentration and real-time PCR.
  • Supplemental quantitative risk assessment for L. monocytogenes in smoked seafood to determine the steps in its production, distribution, sale, and use that contributes to the risk of listeriosis and the potential risk reduction that can be controlled by different mitigation strategies.
  • FDA/CFSAN is developing a risk profile for L. monocytogenes in fresh-cut vegetables.  The risk profile will provide: (1) a review of the available information and identification of major knowledge gaps for the purpose of research planning and priority setting. This information will provide background knowledge needed by Agency risk managers to identify new approaches to controlling this pathogenic foodborne bacterium, and to develop effective food safety guidance for the industry and consumers.
  • FDA/CFSAN is in the process of developing a risk profile for L. monocytogenes in soft cheeses to determine potential strategies for risk reduction with these products.  

Recent Initiatives to Enhance Safety of Produce

FDA has initiated several activities and has worked with collaborators to address safety concerns associated with the production of fresh produce in response to the increase in illnesses associated with consumption of fresh produce.  Some of these activities include: developing guidance, conducting outreach to consumers, sampling and analyzing both domestic and imported produce for pathogens, and working with industry to promote the use of good growing, harvesting, packing, transporting, and processing practices. 

  • 1998, FDA, USDA, and CDC issued guidance for industry, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.  The guidance may be found at:  The agencies issued the guidance in several languages and have conducted significant outreach, both domestically and internationally, to encourage its implementation. 
  • In 2007, FDA issued guidance for industry, Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables. The guidance may be found at: .
  • The CSREES panel for National Integrated Food Safety has for the first time listed produce safety as a priority area.  USDA awarded $1.2 million for collaborative research to identify sources and risk factors of E. coli O157:H7 contamination in fresh produce.  Funds will also be used to inform growers about strategies to prevent pre-harvest contamination.
  • FDA has collaborated with industry, in cooperation with state agencies and academia, to develop commodity-specific supply chain guidance for the commodities most often associated with foodborne illness outbreaks.
  • FDA contracted with the Institute of Food Technologists (IFT) to summarize scientific research relating to the various methods of eliminating or reducing pathogens on whole and fresh-cut produce.  The 2001 report generated as part of the contract with IFT provided important information that is being used to plan and develop future produce safety activities.
  • In October 2004, FDA announced a Produce Safety Action Plan to help reduce the incidence of foodborne illness attributed to the consumption of produce.  The Action Plan has the following four objectives:  preventing contamination of fresh produce with pathogens; minimizing the public health impact when contamination of fresh produce occurs; improving communications with producers, preparers, and consumers about fresh produce safety; and facilitating and supporting research relevant to fresh produce.  This Plan represents the first time that FDA had developed a comprehensive food safety strategy specific to produce.
  • Since 2005, as part of the Produce Safety Action Plan, FDA has provided technical assistance to industry in developing guidance for five commodity groups: cantaloupes, lettuce and leafy greens, tomatoes, green onions, and herbs.  These commodities account for more than 80% of the foodborne outbreaks associated with produce.  Three of the guidance documents (cantaloupes, tomatoes, and lettuce and leafy greens) have been completed.  FDA has conducted outreach and training with the industry to implement the guidance.  FDA is developing commodity-specific guidance for herbs and green onions.  In March 2006 FDA released draft guidance for the fresh-cut produce industry.  FDA finalized this guidance in March of 2007, Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.  See link at: .
  • In August 2006, FDA met with Virginia officials to discuss outbreaks associated with tomatoes produced on the Eastern Shore of Virginia.  FDA is working with the Florida Tomato Exchange and the University of Florida’s Institute of Food and Agricultural Sciences to arrange a forum to discuss ways to improve the safety of tomatoes.
  • A Tomato Safety Initiative was launched in June 2007 in response to recurring Salmonella outbreaks associated with fresh and fresh-cut tomatoes.  The Initiative is a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry.  The Initiative is part of a risk-based strategy to reduce foodborne illness by focusing food safety efforts on specific products, practices, and growing areas that have been found to be problematic in the past.  See link at:
  • FDA twice wrote to industry to express concern over continuing illness outbreaks and to express expectations for industry to enhance the safety of the affected products.  These letters were Notice to Firms that Grow, Pack, or Ship Fresh Lettuce and Fresh Tomatoes,” sent in February 2004, and a Letter to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-cut Lettuce (and leafy greens), sent in November 2005.
  • August 2006, FDA and the State of California launched the Lettuce Safety Initiative at the Forum for Discussion of Lettuce Safety, hosted by the Western Institute for Food Safety and Security (WIFSS).  This initiative was developed as a response to the recurring outbreaks of E. coli O157:H7 associated with fresh and fresh-cut lettuce and leafy greens.  The multi-year initiative is intended to reduce public health risks by focusing on the product, agents, and areas of greatest concern.
  • Through its investigations of farms implicated in previous outbreaks, FDA has identified many possible factors that contribute to the contamination of fresh produce, including the exposure of produce to poor quality water, manure used for fertilizer, workers with poor hygiene, and animals, both domesticated and wild, on the farm.  FDA has been working with the State of California and the industry to promote the adoption of measures to prevent contamination of fresh produce.
  • FDA and the California Department of Public Health are continuing these efforts in 2007 with a focus on a broader range of leafy greens, including spinach, building upon lessons learned in the first year, subsequent outbreak investigations, and from the 2007 Tomato Safety Initiative.  FDA and state investigators, with the cooperation of the industry, are visiting farms in California to assess the prevalence of factors in and near the field environment that may contribute to potential contamination of leafy greens with E. coli O157:H7 and the extent to which GAPs and other preventive controls are being implemented.  Other components of the initiative include continuing outreach with the industry at all points in the supply chain, communicating early and often in the event of an outbreak or recall, and continuing to build and strengthen collaborative relationships with federal, state and local public health officials in disease prevention, detection, and outbreak response.
  • FDA developed and presented a produce farm investigation course (2006 and 2007); and the FDA Guide to Produce Farm Investigations was posted May 3, 2006.  See
  • FDA held day long public hearings on the Safety of Fresh Produce in California and in Maryland in Spring of 2007 to share information about recent outbreaks of foodborne illness associated with microbial contamination of fresh produce, and to solicit comments, data, and other scientific information about current agricultural and manufacturing practices used to produce, harvest, pack, cool, process, and transport fresh produce; risk factors for contamination of fresh produce associated with these practices and possible measures by FDA to enhance the safety of fresh produce.  

Response to Recommendations Received at the 2004 Progress Review: Food Supply Protection

During the first round progress review in 2004, the Food Safety focus area received several recommendations.  One involved food supply protection.  A few of the activities addressing this recommendation are discussed below.

Recommendation:  Integrate the protection of food supplies more thoroughly into planning for measures to ensure homeland security.

  • FDA, in cooperation with Federal and State agriculture and public health agencies, conducted a food security surveillance assignment in 2004.  The assignment served as a prototype for integrating food defense and food safety inspections, sample collection and laboratory testing, compliance and enforcement activities, and logistics for domestic and imported foods including Prior Notice of Imported Foods targeting.  Another exercise to test laboratory sample collection and analysis is being conducted with a focus on both FSIS and FDA-regulated product that goes into the food service industry.
  • In 2005, USDA, FDA, Department of Homeland Security (DHS) and the Federal Bureau of Investigation (FBI) formed a new collaboration with states and private industry to protect the nation's food supply from terrorist threats.  This collaboration is called the Strategic Partnership Program Agroterrorism (SPPA) Initiative.
  • FDA and FSIS have used a risk-assessment tool called CARVER + Shock to help food processors protect their products from deliberate contamination.  The tool can be used to assess the vulnerabilities within a system or infrastructure to an attack.  By conducting a CARVER + Shock assessment of a food production facility or process, the user can determine the most vulnerable points in their infrastructure, and focus resources on protecting the most susceptible points in their system.  CARVER is an acronym for the following six attributes used to evaluate the attractiveness of a target for attack:
    • Criticality - measure of public health and economic impacts of an attack
    • Accessibility - ability to physically access and egress from target
    • Recuperability - ability of system to recover from an attack
    • Vulnerability - ease of accomplishing attack
    • Effect - amount of direct loss from an attack as measured by loss in production
    • Recognizability - ease of identifying target ·             
  • A seventh attribute, Shock, has been added to the original six to assess the combined health, economic and psychological impacts of an attack within the food industry. ·
  • FDA partnered with the Institute of Food Technologists (IFT) and Sandia National Laboratories, Albuquerque, N.M., to computerize CARVER.  The computerized version of the tool became available on FDA's Web site in 2007 at
  • In July 2006, FDA announced its new food defense awareness initiative, ALERT, an acronym that stands for Assure, Look, Employees, Reports, and Threat.  ALERT identifies five key tools that industry and businesses can use to decrease the risk of intentional food contamination at their facilities.  The ALERT initiative is intended to raise the awareness of State and local government agencies and industry representatives regarding food defense issues and preparedness.  It is generic enough to apply to all aspects of the farm-to-table supply chain.  ALERT materials are available in five languages:  English, Chinese, Korean, Spanish, and Vietnamese.
  • In an effort to ensure that all stakeholders have access to the ALERT message, FDA developed a Web-based training module titled, ALERT: Food Defense Awareness.  This training module provides stakeholders with the information they need to begin thinking of ways to prevent intentional food contamination within their area of control.  The ALERT training module is also available electronically at:
  • An FDA-led tabletop exercise that focused on intentionally contaminated bottled water was conducted in 2006 with Federal, State, local agriculture and public health agencies, as well as industry. 
  • FSIS conducted six food-defense tabletop exercises throughout the country in fiscal year 2006 involving over 300 participants to prepare regions to respond to an emergency.  In addition to FSIS, participants included representatives from Federal, State, and local agriculture and public health agencies; consumers; industry representatives; law enforcement officials; and members of the academic community.  Exercises are to continue through at least next year.  FSIS also conducted tabletop exercises in the event of avian and human pandemic influenza outbreaks.
  • FSIS has developed procedures and an automated incident management system to facilitate its response to non-routine incidents including an intentional contamination of the food supply, illegal imports, and potentially high-risk shipments of imported product.
  • A number of USDA agencies, including FSIS, along with FDA, DHS, and the Federal Bureau of Investigation are part of the Strategic Partnership Program Agroterrorism, a program that carries out joint vulnerability assessments on the food supply.  The assessments have shown, among other things, commonalities across food and agricultural industries that make them more vulnerable to attack, and generic protective measures or mitigation strategies that could be beneficial to the industries assessed.[15]  FSIS has completed over a dozen vulnerability assessments, which are updated periodically.
  • FSIS, in collaboration with FDA, DHS’ Customs and Border Protection (CBP), the USDA Office of the Inspector General, and APHIS developed cooperative protocols for managing high-risk shipments between FSIS and CBP, based on FSIS’ vulnerability assessments on legally and illegally imported foods.  These protocols have been pilot tested at two ports of entry and will be refined and implemented nationwide. 
  • In 2004 and 2005, FNS and AMS joined with FSIS to conduct vulnerability assessments of products used in the National School Lunch Program.  These assessments identified strengths and weaknesses in the lunch program.
  • In 2006, FSIS, FNS, and the USDA’s Agricultural Marketing Service (AMS) partnered with FDA in the development and delivery of food vulnerability awareness training.  FSIS conducted training at 14 sites around the country, educating 1,200 employees from FSIS and other Federal, State, and local regulatory agencies, local law enforcement, and food program administrators.  The training is available at FDA’s Office of Regulatory Affairs online university training Web site:  To augment this effort, FSIS is working closely with the Department of Transportation to provide food defense awareness training for motor carrier and rail safety inspectors.
  • To prepare industry to protect the domestic food supply from an intentional attack, FSIS has provided training to more than 700 trade group representatives across the country.  This training assists plant owners and operators in determining the vulnerabilities of their specific facilities and in developing countermeasures.  The training has resulted in industry voluntarily implementing security measures.  
  • Working to protect the world’s food supply, government agencies have participated in and conducted workshops to enhance coordination with international trading partners.  Workshops have been held for the Canadian and Mexican governments and the G8 Food Bioterrorism Expert Working Group.  In collaboration with the U.S. Department of State, FDA, FSIS, and the USDA’s Foreign Agricultural Service held a similar workshop in Thailand for the Asia-Pacific Economic Cooperation (APEC) Economies’ Counter-terrorism Task Force.  Seventeen APEC countries participated in this workshop which assisted countries in identifying their own vulnerabilities and developing countermeasures for imported and exported food products.
  • FSIS is actively working with intelligence and law enforcement communities to strengthen communication and coordination on food defense preparedness and response activities.  To ensure that the collection and analysis of intelligence information considers food defense concerns, FSIS provides key information to these agencies through information briefings and routine information-sharing forums.  Additionally, FSIS co-authored a classified briefing on food terrorism for the intelligence community of which more than 1,000 copies have been distributed to over 180 U.S. intelligence installations worldwide.
  • FSIS, FDA, CDC, and the Environmental Protection Agency support the Food Emergency Response Network (FERN), a system of State and Federal laboratories positioned to analyze food samples should there be a biological, chemical, or radiological terrorist attack in the United States.  In 2006, USDA agencies, FSIS, FNS, and AMS developed a pilot project to test ground beef at a processing facility and a State warehouse supplying ground beef to the National School Lunch Program.  The project, which included four volunteer States, concentrated primarily on the communication and coordination for detection of suspected harmful agents in commodity food products.  FERN regions and laboratories can be viewed at:
  • FNS developed and disseminated the Biosecurity Checklist for School Foodservice Programs: Developing a Biosecurity Management Plan for National School Lunch Program operators in 2003.  The publication was distributed to 22,000 school food authorities.  Based on the checklist, FNS, in cooperation with the National Food Service Management Institute, developed a food defense teaching resource that contains a 12-minute video on DVD and VHS, an Excel spreadsheet, an interactive CD-ROM, and a complementary interactive Web site.  Additionally, materials were duplicated, packaged, and distributed in 2006 to school food authorities. ·         FNS recognized the need to improve surveillance and tracking capabilities and decrease communication time with program operators when problems are discovered with USDA-purchased commodity products for nutrition assistance programs.  The Rapid Alert System, an integral part of the Electronic Commodity Ordering System, was developed to allow electronic tracking and two-way communication with States and recipient agencies.  Through FSIS’ CCMS (Consumer Complaint Monitoring System), FNS receives complaint information on commodities distributed within the USDA nutrition assistance programs.  CCMS provides an early warning to FNS about problems with foods in the commercial market that might also be distributed within the USDA programs; the rapid alert system expands the surveillance capabilities of FNS.    

Antimicrobial Drug Resistance

10.3 Prevent an increase in the proportion of isolates of non-Typhi Salmonella species from humans that are resistant to antimicrobial drugs.

Salmonella isolates from humans that are resistant to:
10.3a Fluoroquinolones
10.3b Third-generation cephalosporins
10.3c Gentamicin 10.3d Ampicillin 10.3e through
10.3p (Subobjectives deleted due to lack of data source)

Data for objective 10.3 are obtained from the National Antimicrobial Resistance Monitoring System (NARMS)[16].  NARMS was established in 1996 in response to concerns regarding increased antimicrobial resistance.  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 is a collaborative program between FDA, CDC, FSIS, ARS, APHIS, and all 50 States to monitor trends in antimicrobial susceptibilities of foodborne enteric organisms.  The program is administered by the FDA Center for Veterinary Medicine (CVM).  

Challenges and Barriers:

  • Bacterial antimicrobial resistance is increasing the overall illness, death, and economic costs associated with treating bacterial infections caused by resistant organisms.  
  • After several decades of successful antimicrobial use, multiresistant bacterial pathogens are emerging that are less responsive to treatment.  For example, non-Typhi Salmonella strains from humans are demonstrating emerging resistance to the newest antibiotics, such as fluoroquinolones and third-generation cephalosporins.  However, for older, less-prescribed antibiotics, such as gentamicin and ampicillin, resistance has decreased.
  • Although most reported Salmonella cases in the United States are associated with a relatively small number of serotypes – some of which are commonly found in raw meat and poultry products – there has been increasing concerns about outbreaks attributed to relatively rare strains of Salmonella resistant to multiple antibiotics.  See  

Strategies and Opportunities:

  • An initiative that may provide valuable data for forming future Healthy People objectives is the 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.
  • The NARMS/FoodNet Retail Food Study is an ongoing collaboration between the FDA CVM, CDC, and all 10 of the current FoodNet laboratories to monitor the presence of antimicrobial drug resistance among E. coli, Salmonella, Campylobacter, and Enterococcus from samples of fresh meat and poultry purchased monthly from grocery stores in the participating States.  Bacterial isolates are sent to CVM for confirmation of species, antimicrobial susceptibility testing, and genetic analysis.  The most recent report available is from the 2004 surveillance.[17]


  • The CDC, in collaboration with the American Medical Association (AMA), among others, 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 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. 
  • CVM developed educational materials to educate veterinarians and food animal producers regarding prudent use of antimicrobial drugs.  These include individual pamphlets describing the judicious use of antimicrobials specifically for swine, poultry, 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 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. 
  • 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 15 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.


  • 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.  Two studies on the prudent use of antimicrobial drugs in swine were completed in 2003 at Ohio State and Tufts universities. 
  • The three participating NARMS laboratories are conducting research into the genetic determinants of resistance.  USDA’s ARS has developed microarray technology to identify resistance determinants in Enterococcus species.  ARS has also developed the VetNet program in collaboration with CDC’s PulseNet.  VetNet 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:

  • In 2005, FDA announced that it would no longer allow distribution or use of the antimicrobial drug enrofloxacin for the purpose of treating bacterial infections in poultry.[18]  This ruling did not affect other approved uses of the drug.  This animal drug belongs to a class of drugs known as fluoroquinolones.  This action is the result of a risk assessment conducted by CVM that determined that there is a risk to human health from the consumption of antimicrobial resistant Campylobacter organisms found in poultry.  

Food Allergies

10-4 Reduce deaths and illness from severe food allergies.

10.4a Deaths from anaphylaxis from food allergies in total population
10.4b Severe allergic reactions among adults aged 18 years and older

Challenges and Barriers:

  • In the United States, 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.  For certain individuals, the presence of allergens in food can be life threatening.  Currently, there is no cure for food allergies.  The only successful method to manage food allergies is to avoid foods containing the allergen.  Formulated foods present a separate challenge.  In such cases, the individual relies on accurate ingredient labeling.[19]
  • Deaths due to anaphylaxis from food allergies are underreported.  For this reason, the Healthy People 2010 Food Safety Focus Area Work Group has not set a reduction goal for the year 2010.
  • In 2006, FDA conducted health professional focus groups addressing food safety and food allergy issues.  Some of the key feedback from these groups was that they did not know about the International Classification of Diseases (ICD) codes for food allergy anaphylaxis which affected deaths certificates, etc. 
  • In the ICD-10, food allergy is listed as a multiple cause, not an underlying cause of anaphylaxis, additionally complicating coding.

Strategies and Opportunities:

  • Congress approved the Food Allergen Labeling and Consumer Protection Act of 2004 in August 2004 (FALCPA).  As a result of FALCPA, manufacturers are required to identify, in plain English, the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say "contains" followed by the name of the source of the food allergen after or adjacent to the list of ingredient.  See
  • Effective January 1, 2006, FDA required food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods.  This labeling will be especially helpful to children who must learn to recognize the presence of substances they must avoid.  For example, if a product contains the milk-derived protein, casein, the product's label will have to use the term "milk" in addition to the term "casein" so that those with milk allergies can clearly understand the presence of the allergen they need to avoid.
  • In 2005, FDA made available Guidance for Industry:  Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (4th Edition).  The guide may be found at:
  • FDA plans to develop an educational program for health professionals to advise them regarding reporting deaths from anaphylaxis due to food allergies and instructing them on the correct ICD 10 and ICD 10CM codes.  This program will be based on health professional focus groups conducted in 2006, and is being addressed by working with an educational development firm targeting the development of an educational program on food allergies for health professionals.  The program also will provide instructions on reporting the incidence of anaphylaxis due to food allergies and the use of appropriate codes. 
  • Through participation in annual meetings for health care professionals, FDA will continue to provide food safety educational materials for their information and for them to advise their patients.  FDA is also disseminating the second edition of the publication, Diagnosis and Management of Foodborne Illnesses: a Primer for Physicians and Other Health Care Professions, a collaborative effort of the AMA, CFSAN, CDC, and FSIS. 
  • FDA is continuing to work with the Conference for Food Protection’s Food Allergen Committee concerning FALCPA for its review of guidelines for the retail-level foodservice and retail store industries. 
  • FDA has instituted a new series of brief consumer publications, Food Facts from FDA, which cover a variety of food safety, nutrition, and food allergen issues.
  • In May 2006, FSIS published a document in the Federal Register, “Use of Ingredients of Potential Public Health Concern,” to inform establishments preparing meat and poultry products of the need to ensure proper control over ingredients that present a potential public health concern.  Establishments were asked to consider the control of ingredient use, particularly use of those identified by FALCPA, and actions that should be taken to maintain proper control through the production process when conducting annual HACCP assessments.    

Consumer Food Safety Practices

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

Challenges and Barriers:

  • 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.

Strategies and Opportunities:

An important national program to educate the public about food safety is the Fight BAC! ™ campaign.  For over 10 years, USDA, FDA, and CDC, have served as the Federal liaisons to The Partnership for Food Safety Education, the public/private partnership that created the Fight BAC!™  campaign.  This national program emphasizes the four basic safe food handling behaviors: Clean, Separate, Cook, and Chill.  These behaviors are the basis of the choice of questions from the Food Safety Survey that we are using in Healthy People 2010 to measure changes in consumer food safety practices.

Efforts to meet the goals of the Healthy People 2010 initiative were advanced, in part, by aggressive consumer education outreach programs.  Examples of FSIS’ efforts include media events promoting the four key food safety messages of clean, separate, cook, and chill; consumer brochures; public service announcements for keeping food safe during power outages; Spanish-language food safety brochures including the development of five brochures on food safety for at-risk audiences:  people with cancer, HIV/AIDS, diabetes, transplant recipients, and older adults.  FSIS provides a toll-free telephone service to help prevent foodborne illness by answering consumer questions about the safe preparation and handling of food.  The toll-free phone number for the Meat and Poultry hotline is 1-888-MPHotline 1-888-674-6854: TTY 1-800-256-7072.

The FDA 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, food additives, and food biotechnology.  To provide up-to-date information to inquirers, staffed line hours are expanded early and late and on weekends, and operator numbers increased, during larger food-borne illness emergencies, such as the E. coli O157:H7 outbreak from packaged spinach in 2006.  The O&IC responds to approximately 20,000 calls and e-mail inquiries from consumers and regulated industry each year.  1-888-SAFEFOOD (1-888-723-3366).

Specific initiatives (Additional initiatives and series of educational materials are described under “Recommendations and Actions,” below.):

  • September is National Food Safety Education Month™.  Educational materials are available to health educators; a kit of consumer educational information is available at:
  • Thermy™ is part of a multi-year national thermometer education campaign that was launched in 2000 by FSIS in cooperation with the Partnership for Food Safety Education, the Food Thermometer Indicator Association, and a number of grocery chains across the country.  This ongoing campaign promotes the use of food thermometers when cooking meat, poultry, and egg products to determine if they have been cooked to a safe minimum internal temperature.
  • In 2005, FSIS launched a nationwide campaign, Is It Done Yet? You Can’t Tell By Looking. Use a Food Thermometer.  The campaign targets families with young children and other at-risk populations to affect positive behavior changes.
  • FSIS introduced the Food Safety Mobile in 2003 to deliver food safety education messages to consumers, educators, and other interested parties at the local level.  It was used extensively in the aftermath of Hurricane Katrina to deliver the food safety message.  The last Food Safety Mobile visit occurred in November 2005.  The program is not currently operating due to fiscal constraints.
  • “Ask Karen,” a Web-based communications tool, is an automated response system that debuted in April 2004.  This “virtual representative,” available 24/7, is designed to display an answer based on the words typed by users of the feature.  “Ask Karen” responds, from an extensive database of food safety information, to inquiries from the public about the safe handling, preparation, and storage of meat, poultry, and egg products.  “Ask Karen” may be accessed through:
  • FDA has instituted a new series of brief consumer publications, Food Facts from FDA, which cover a variety of food safety, nutrition, and food allergen issues.
  • A nationwide food safety campaign called Be Food Safe, which includes print and broadcast advertisements, was launched in September 2006 at the Food Safety Education Conference, Reaching At-Risk Audiences and Today’s Other Food Safety Challenges, co-sponsored by FSIS.  This new educational mass media campaign gives educators the tools to inform consumers about foodborne illness and raise awareness of the dangers associated with improper handling and undercooking of food.  A new quarterly food safety magazine, be FoodSafe: The FSIS Magazine, was also unveiled at the September 2006 conference.
  • A Spanish-language brochure, Todo Cuenta Cuando se Trata de Cuidar a su Familia (Everything Counts When it Comes to Protecting Your Family), was also unveiled at the 2006 Food Safety Education Conference to educate the Hispanic community on why food safety should be important to them.
  • FDA annually provides seed funding for 14-20 grassroots food safety education projects to FDA Public Affairs Specialists in the field.  These projects typically involve partnerships with local extension agents, health departments, schools, media, and/or businesses and reflect a broad range of activities, from multicultural consumer education to train-the-trainer programs for food service workers to contests for schoolchildren.
  • The Interstate Shellfish Sanitation Conference, a cooperative relationship among FDA, National Marine Fisheries Service, Environmental Protection Agency, the States, and the shellfish industry assures that uniform shellfish control measures are adopted, and that those measures are enforced consistently by State regulatory authorities.  The conference also provides educational information about molluscan shellfish, Vibrio vulnificus, and Vibrio parahaemolyticus.  See
  • In cooperation with the California Department of Health Services, FDA developed and implemented a program to educate the Latino community on the dangers of eating raw molluscan shellfish because they may be contaminated with the bacteria Vibrio vulnificus, which can cause serious illness or death.  This is a particular concern in the Hispanic community since raw oysters are a favorite food, especially among Hispanic males.  The program is centered on a fotonovela, a popular means of communicating information in Hispanic communities.  This program has been effective among Hispanic populations in other parts of the country.
  • FDA has produced a bilingual tool kit, available on its Web site, to help local health educators inform the Hispanic community about the dangers of eating raw oysters. How to Generate Awareness of Vibrio vulnificus of Raw Oysters with the Hispanic Community includes tools a health educator needs to conduct a media relations and community outreach health education campaign.  The tool kit, available in a brochure format, is available electronically at: toc.html.

Response to Recommendations Received at the 2004 Progress Review: Consumer Food Safety Practices

During the first round progress review in 2004, the Food Safety focus area received several recommendations.  A few of the activities addressing recommendations on consumer safety practices are discussed below.

Recommendation 1: Urge States to make training in food safety a part of the curricula of school science classes. 

  • The K-3 Presenter's Kit, a compendium of games, songs and coloring materials utilizing the Fight BAC! ™ character has been widely distributed to elementary schools and has proven effective with preschoolers as well.
  • Your Game Plan for Food Safety, for grades 4-6, includes an award-winning video and food safety-related experiments to teach basic microbiological concepts illustrating the importance of the four key behaviors.  Developed in partnership with the National Science Teachers Association (NSTA), some 17,000 copies are now in use by teachers across the country.
  • Science and Our Food Supply, a supplementary food safety curriculum for middle and high school students, developed by FDA and NSTA, is in wide use with more than 23,000 copies distributed in response to teacher requests.
  • Each year, as part of an ongoing public health partnership with the National Science Teachers Association (NSTA), CFSAN provides a week of immersion training in food safety to middle school and high school science teachers.  To date, 380 teachers from all 50 States, the District of Columbia, the U.S. Virgin Islands, Guam, and Puerto Rico have completed this program, which began in 1999.  As part of their agreement to complete this summer training, participants train other teachers.  This effort has now reached more than 7,000 teachers and 2.0 million students nationwide.  In 2007, the summer program expanded to included topics in nutrition and food allergies, and online food safety lesson plans were added for teachers to access from anywhere.
  • In May 2007, USDA hosted a food safety education camp for more than 60 fourth-grade students from Prince George’s County Schools in Maryland.  Students had the opportunity to interact with scientists, food safety experts, and government officials and to experiment and participate in hands-on activities at various stations.  The activities helped the students learn important food safety lessons and illustrated USDA’s food safety education principles of Clean, Separate, Cook and Chill.

Recommendation 2:  When appropriate, incorporate advice about good nutrition into public messages about food safety practices.

  • FDA's recent food safety publications, e.g., Fresh and Frozen Seafood, and Safe Handling of Raw Produce, reference the nutritional values of these food groups.  In addition, FDA has instituted a new series of brief consumer publications, Food Facts from FDA, which cover a variety of food safety, nutrition, and food allergen issues. 

Recommendation 3:  Take additional steps to protect the health of groups at greatest risk of morbidity and mortality from L. monocytogenes, including pregnant women and their fetuses, newborns, the elderly, diabetics, and those with compromised immune systems.

  • FDA's bilingual Food Safety for Moms-To-Be (MTB) health educators’ toolkits, are now in use by more than 50,000 health educators along with the MTB interactive Web site, which emphasizes listeriosis prevention.  In addition, FDA has tested a Preventing Listeriosis in Pregnant Hispanic Women health educators’ toolkit and Web site.  These toolkits were distributed in February 2007 to 10,000 recipients of the USDA’s Women, Infants and Children and Extension programs.
  • FSIS continues to distribute a plain language flyer, Protect Your Baby and Yourself from Listeriosis, in Spanish and English, featuring information about suitable food for pregnant women to eat to avoid listeriosis.   

Food Safety Practices at Retail

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

10.6a Safe retail food preparation - Hospital
10.6b Safe retail food preparation - Nursing home
10.6c Safe retail food preparation - Elementary school
10.6d Safe retail food preparation - Fast-food restaurant
10.6e Safe retail food preparation - Full-service restaurant
10.6f Safe retail food preparation - Deli departments
10.6g Safe retail food preparation - Meat/poultry departments 10.6h Safe retail food preparation - Produce departments
10.6i Safe retail food preparation - Seafood

Challenges and Barriers:

  • Continuous high employee turnover rates in retail-level food establishments creates an environment not conducive to maintaining a well-trained workforce with food safety knowledge in areas such as food temperature control, food preparation practices, personal hygiene and employee health.
  • Many retail-level food establishments do not provide paid sick leave for food employees.  While a policy may be in place for employee health, if it does not include paid sick leave, many food employees still come to work ill.

Strategies and Opportunities:

  • In 2008, FDA will again collect data for its third retail level establishment risk factor study.  Data were collected in 1998 and 2003 at nine facility types.  The 2008 data are expected to be released in 2010.
  • Food Safety Education funds were provided to reinforce and expand FNS’ efforts to provide continuous, effective training and technical assistance in food safety to Child Nutrition Program operators.  Child Nutrition Programs include the National School Lunch and School Breakfast programs, the Child and Adult Care Food Program, and the Summer Food Service Program, among others.  FNS develops materials, ensures their delivery, makes training available, and facilitates the implementation of food safety requirements into the operators’ food service operations.  An example is the development of school food safety programs based on HACCP principles. 
  • FNS collaborated with CDC and members of the National Coalition for Food Safe Schools, to develop the Food-Safe Schools Action Guide kit.  The Action Guide, released in June 2005, highlights a team approach to school food safety.  Thekit contains Action Sheets for members of the school community including food service staff, teachers, nurses, administrators, families, health department staff, and cooperative extension staff, and contains a short list of customized recommendations for what can be done to prevent school foodborne illness.  Limited hard copies of the Action Guide are available.  One copy was sent to each FNS State agency.  The contents of the Action Guide can be downloaded at the following Web site:
  • Funds were provided to the National Food Service Management Institute (NFSMI) under its grant and cooperative agreement with FNS.  NFSMI will continue long-term, comprehensive food safety education projects.  Examples of trainings held and materials distributed in cooperation with NFSMI include:
    • HACCP training materials were updated to reflect school food safety programs based on HACCP principles including the development of a participant and trainer workbook and a set of instructional videos.  A satellite seminar on the topic was conducted in October 2006.  Materials are available on the NFSMI Web site at:
    • Training programs, specifically on the School Food Safety Program based on HACCP, were presented to more than 7,700 participants in 35 States from January 2005 through December 2006.
    • interactive and customizable set of standard food safety operating procedures for school food service operations is available on the NFSMI Web site at:
    • Serving It Safe, a basic food safety training manual for school food service staff, was developed in 1996 and updated in 1999 by FNS.  Twenty five thousand copies of the manual were printed and distributed to School Food Authorities.  In 2003, Serving It Safe was updated with current food safety and Food Code information, reprinted, and distributed to all School Food Authorities and Adult Care Food Program operators.  In 2005, a Spanish language version was developed.  Thirty two thousand copies of the Spanish manual were distributed.  The manuals are available at:
    • A Thermometer Information Resource and CD-Rom wasdeveloped, printed, and distributed.  Approximately 35,000 copies were distributed. The resource is available at:
    • Wash Your Hands! Training package, including a video, posters, CD-ROM with files and resources, booklet, an ultra violet glow potion and powder and ultra violet light in a tote bag was developed and reproduced.  In 2004, approximately 63,000 packages were distributed to Child Nutrition Program operators including schools and child care centers.
    • In 2004, a food safety resource for the Summer Food Service Program was developed which included a booklet with lesson plans and handouts for three food safety lessons:  personal hygiene, cooking and holding temperatures and preventing cross-contamination, plus 14 food safety mini-posters.  Approximately 15,000 copies were distributed.
    • In 2002, Responding to a Food Recall resource was developed and distributed to State agencies and School Food Authorities.  The resource included a leader guide, brochures, poster, and resource manual.
    • In 2002, a set of 10 food safety mini-posters were designed for child care centers and refrigerator posters were designed for day care homes.  Approximately 54,000 were distributed to child care centers and 184,000 to day care homes.      

Response to Recommendation Received at the 2004 Progress Review: Food Safety Practices at Retail

During the first round progress review in 2004, the Food Safety focus area received several recommendations.  A few of the activities addressing a recommendation on food safety practices at retail are discussed below.

Recommendation: Explore innovative approaches to effecting desirable behavior changes in employees of retail food and food service establishments.

The following are the most recent activities to improve food employee food-preparation practices.

  • FDA made available a satellite broadcast on the reduction of risk factors for foodborne illness in retail food establishments.  The goal of the program is to improve the ability of regulators and industry to reduce the occurrence of risk factors and foodborne illness at retail establishments.  Success stories and tools were discussed through interviews with various leaders in the regulatory community and industry.  Topics included communication skills, using risk control plans, tools for improving food employee behaviors, food preparation practices, personal hygiene of foodservice workers, and techniques used to ensure safe food temperatures.  Additional information, including the broadcast, may be found at:
  • A second broadcast is planned on the subject of Employee Health for late 2007 or 2008.  It will focus on the FDA Food Code provisions for preventing the transmission of foodborne illness from ill employees.
  • An Employee Health Handbook and a slide series of employee health messages have been developed and are in the early stages of clearance with CFSAN.  The Handbook is a user-friendly means of providing to industry and regulatory agencies the sometimes confusing provisions of the Food Code for ill employees.  


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

This objective was deleted due to negligible presence of organophosphate pesticide residues found in foods. 

The originally proposed measure was to be based on a calculation of human exposure from food consumption data and pesticide residue data.  The CDC National Center for Environmental Health’s National Report on Human Exposure to Environmental Chemicals provides a more direct measure of exposure/body burden through biomonitoring.[20]  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 through 8-24d in the Environmental Health Focus Area for data on exposure to four pesticides[21].  

Addendum No. 1: Import Safety Action Plan

The Import Safety Action Plan (Action Plan) was developed by the Interagency Working Group on Import Safety and presented in November 2007[22].  The Action Plan contains short and long-term recommendations for continuing to improve the safety of imports entering the United States.  It proposes a strategy focused on a risk-based prevention with verification model that allocates import safety resources based on risk. The bases of the Action Plan include  

  1. Creating A Stronger Certification Process
  2. Encouraging Good Importer Practices
  3. Increasing Transparency
  4. Exchanging Import Data
  5. Increasing U.S. Presence Overseas
  6. Enhancing Standards
  7. Strengthening Penalties. 

Addendum No. 2: FDA Food Protection Plan

In conjunction with the Import Safety Action Plan, theFDA has developed a comprehensive Food Protection Plan[23] [24] to address the changes in food sources, production, and consumption that we face in today's world.  Building upon and improving FDA’s current preventative approaches, the new plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack.  FDA's Food Protection Plan (the Plan) builds in prevention first, then intervention, and finally, response.  This strategy, introduced November 6, 2007, will help ensure that Americans continue to benefit from one of the safest food supplies in the world. 

The Food Protection Plan addresses both food safety and food defense for domestic and imported products.  It operates through a set of integrated strategies that focus on risks over a product's life cycle from production to consumption, target resources to achieve maximum risk reduction, address both unintentional and deliberate contamination, and use science and modern technology systems.  The Plan focuses FDA’s efforts to prevent problems before they start.  It employs risk-based interventions to ensure preventive approaches are effective.  And it provides for a rapid response when contaminated food or feed are detected, or when there is harm to humans or animals.  To meet the above goals, the FDA Food Protection Plan outlines specific actions and requested legislative authorities to strengthen FDA's ability to continue to protect Americans from foodborne illnesses.

The Food Protection Plan will support the FDA's ongoing collaboration with FSIS and CDC.  Both the Import Safety Action Plan and Food Protection Plan recommend that FDA be authorized to pursue the mandatory recall of food products.  Granting FDA this authority would enable it to achieve the same level of recall compliance as USDA, which has the authority to withdraw its inspectors from a food processing facility when faced with similar situations.   

Addendum No. 3: FSIS E. coli O157:H7 Initiatives

In October 2007, following an increased number of E. coli O157:H7 positive tests in beef, as well as a larger number of recalls and illnesses caused by this pathogen than in recent years, FSIS announced new, ongoing, and upcoming actions to protect public health against the risk of E. coli O157:H7[25] [26]. They include:

  • Verifying Control of E. coli O157:H7. As of November 2007, all beef plants are expected to verify that they are effectively controlling E. coli O157:H7 during slaughter and processing.  FSIS provided specific examples of minimum controls that would meet the minimum criteria for a "well-controlled" process.
  • New Checklist for Verifying Control. FSIS will review both suppliers and processors based on a new checklist, which will help the agency quickly identify significant changes in a plant’s production controls and ensure corrective action is taken. 
  • Testing Ground Beef Components. In addition to testing beef trim, which began in March 2007, FSIS will test other materials used as components in raw ground beef. Countries that export beef to the U.S. are required to conduct the same sampling or an equivalent measure.
  • More Rapid Recalls. FSIS will now take into account a broader, more complete range of evidence when evaluating whether to seek a recall or take regulatory action.
  • Targeted Routine Sampling. In January 2008, FSIS will begin routine targeted sampling for E. coli O157:H7 at slaughter and grinding facilities. Larger volume operations will be tested more frequently than in the past.
  • Safety of Imported Beef Products. FSIS notified countries that export raw beef product to the U.S. of the new E. coli O157:H7 policies and programs and is working with them to ensure they implement the same or equivalent measures.
  • Working with Small Plants. In October 2007 FSIS began conducting outreach and training sessions on the new initiatives for small and very small raw beef processors, other stakeholders, and FSIS inspection program personnel.
  • Working with Public Health Partners. FSIS will meet with State and local public health partners, FDA, CDC, industry, and consumer groups to discuss how to improve outbreak investigations and recalls conducted by FSIS in collaboration with these partners.  

Addendum No. 4: HHS and China Agreement on Food and Feed Safety

On December 11, 2007, the Department of Health and Human Services of the United States of America and the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China signed an agreement on the Safety of Food and Feed.  The full text of the agreement is available at this link

The agreement states:

The purpose of this Agreement is to establish a bilateral cooperative mechanism regarding food and feed safety.  Such a mechanism may include current and future registration and certification systems.  The mechanism aims to provide the Parties with information to use in judging whether an imported product meets the requirements of the importing country.

[1] Mead, P.S., L. Slutsker, V. Dietz, L.F. McCaig, J.S. Bresee, C. Shapiro, P.M. Griffin, and R. V. Tauxe.  1999.  Food-Related Illness and Death in the United States.  Emerging Infectious Diseases 5(5):607-625.

[2] See Addendum, page 37, for updates.

[3] U.S. Department of Agriculture, Food Safety and Inspection Service.  2007. FSIS Takes Aggressive Actions To Combat E. Coli O157:H7. Available at the following link:

[4] Additional information about the E. coli initiatives is available at the following link:

[5] Import Safety Action Plan Fact Sheet.  November 6, 2007.

[6] Food and Drug Administration.  2007 Food Protection Plan.

[7] Department of Health and Human Services of the United States of America and the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China Agreement on the Safety of Food and Feed.

[8] Centers for Disease Control and Prevention.  2007.  Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food – 10 States, 2006.  Morbidity and Mortality Weekly Report 56(14); 336-339, available at the following link:

[9] FSIS data may be found at

[10] FSIS data may be found at

[11] FSIS data may be found at

[12] FDA produce initiatives are described on pp 18-21.

[13] FSIS data may be found at  

[14] Section 111 of the Child Nutrition and WIC Reauthorization Act of 2004 (Public Law 108-265).  The Reauthorization Act amended section 9(h) of the Richard B. Russell National School Lunch Act.

[15] U.S. Food and Drug Administration, Department of Homeland Security, U.S. Department of Agriculture, and Federal Bureau of Investigation, July 2006.  Strategic Partnership Program Agroterrorism (SPPA) Initiative, First Year Status Report September 2005-June 2006.

[16] Food and Drug Administration.  National Antimicrobial Resistance Monitoring System.

[17] NARMS Retail Meat Annual Report 2004.

[18] Food and Drug Administration.  FDA Announces Final Decision About Veterinary Medicine.  July 28, 2005.

[19] Falci, K.J., K.G. Gombas, and E. L. Elliot.  2001. Food Allergen Awareness:  An FDA Priority.  Food Safety Magazine 7(1):14-15, 43-44. February-March, 2001.

[20] Centers for Disease Control and Prevention.  2005.  National Report on Human Exposure to Environmental Chemicals 2005.

[21] Healthy People 2010 Progress Review Focus Area 8:  Environmental Health.  February 2, 2007.

[22] Import Safety Action Plan Fact Sheet.  November 6, 2007.

[23] Department of Health and Human Services, Food and Drug Administration.  2007.  Food Protection Plan.  Available at the following link:

[24]  Additional information about the Food Protection Plan is available at the following link:

[25] U.S. Department of Agriculture, Food Safety and Inspection Service.  2007. FSIS Takes Aggressive Actions To Combat E. Coli O157:H7. Available at the following link:

[26] Additional information about the E. coli initiatives is available at the following link:   

Page Last Updated: 07/30/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English