FDA 1997 Food Code - Introduction
U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
1997 Food Code
Introduction - FDA
It has been over three years since FDA published the revised Food Code which provided "the latest and best scientifically based" food safety advice for those responsible for regulating retail establishments. That document included many new intervention strategies and encouraged the use of HACCP to prevent foodborne illness. This 1997 edition has been revised again based on input from many sources, and I believe it reflects, not only outstanding science, but also an open, deliberative process.
The timing of this 1997 edition of the Food Code is fortuitous. It issues as the FDA, CDC, USDA and the EPA embark upon the Food Safety Initiative announced by President Clinton on January 25, 1997. The Food Code serves as one important tool which enables the public health community and the retail food industry to answer the challenge of reducing foodborne illness.
I call your particular attention to the new Part 8 that has been added to Chapter 3 to clearly delineate safeguards for "highly susceptible populations." The growing number of elderly and immunocompromised, as well as America's future - its children - deserve our special attention. Because the success of any nation is measured by the health and welfare of its citizens, it is essential that the public health advice contained in this 1997 Food Code be implemented.
The Food Code is, however, only a framework upon which an effective retail food safety program can be built. I urge federal, state, and local food regulatory agencies to:
adopt these recommendations into their rules, ordinances and laws;
keep these rules, ordinances and laws current;
assure that a trained cadre is available to administer them; and
- enforce, fairly but vigorously, all of the provisions necessary to protect the public health.
There is still much to do to reach our important goal of reducing foodborne illness, but working together, it can be achieved.
Michael A. Friedman, M.D.
Lead Deputy Commissioner
Food and Drug Administration
This is the 1997 Food Code. It has been revised to include recommendations and views from many parties, notably the Conference for Food Protection (CFP) and the Association of Food and Drug Officials (AFDO).
Though this document represents a significant degree of consensus, the issue of the Consumer Advisory (Chapter 3, Part 602.12) continues to be of concern to many parties. Since the 1993 Food Code, the Food and Drug Administration (FDA) has insisted that consumers need to know about the increased health risk associated with consumption of raw or undercooked foods of animal origin so that they could make proper decisions. In the 1993 Code, the Agency recommended a point-of-sale "advisory," but did not specify language. The CFP debated this issue at great length, with regulators and consumer and industry representatives having an opportunity to comment. Compromise language was developed at the CFP meeting in Denver and submitted to FDA for inclusion in the new Food Code.
FDA subjected the CFP-recommended language to representative consumer focus groups in three states. The cumulative information obtained through this process was not supportive of the language nor of the method of communication, i.e., there was resistance to, and skepticism about, menu notices and some misunderstanding of the message. Consequently, the language recommended by the CFP is not included in the 1997 Code.
However, FDA continues to believe that it is the shared responsibility of the industry, regulators, and the medical community to ensure proper information is available so that consumers make knowledgeable food choices. Therefore, when consumers are advised, FDA supports the use of a uniform message and suggests that the CFP-recommended language be used until a more meaningful advisory is developed.
FDA will continue to explore through its educational initiatives and processes and with the CFP and other groups, ways to effectively communicate the risk of foodborne illness associated with certain foods. The Agency will issue further guidance either as an interim interpretation before issuance of the 1999 Food Code or as part of that Code.
We recognize the desire of all parties to have a document for uniform adoption.
Though this compromise may not satisfy the desires of all parties for a single statement, we hope it will lower the level of rhetoric and allow time to develop a more acceptable approach to this important issue.
Despite the difficulties associated with the consumer advisory, there has been important progress in the development of this revised retail food safety guidance document. This is reflected in, not only the endorsement from the Lead Deputy Commissioner of the Food and Drug Administration, but in the strong support from the U.S. Department of Agriculture's Food Safety and Inspection Service and from the Department of Health and Human Services' Centers for Disease Control and Prevention. This federal food safety "triumvirate" is speaking with one voice.
We encourage your support and adoption of the 1997 Food Code.
Fred R. Shank, Ph.D.
Center for Food Safety and Applied Nutrition
Food and Drug Administration
The public health burden of foodborne diseases in the United States is substantial. Each year millions of persons become ill, and thousands die from foodborne diseases.
The cost of these illnesses to the U.S. economy is several billion dollars annually.
Many different pathogens and toxins have been identified as causes of foodborne disease, and new ones continue to emerge. The numbers of Americans at especially high risk of foodborne infections and serious consequences of foodborne illnesses are increasing, including preschoolers in childcare centers; the elderly, particularly those who live in congregative settings; and persons who are immunocompromised.
Foodborne diseases due to infectious agents and natural and environmental toxins can be prevented. Many foodborne diseases that were formerly threats to the public health are now controlled by standardized, well-accepted prevention strategies such as the pasteurization of raw milk and the appropriate management of the canning of foods.
The increasing food safety problems we face as a Nation require rapid and effective responses. To meet this complex public health responsibility, we must strengthen the Nation's capacity to predict and prevent foodborne hazards, to monitor and rapidly react to outbreaks of foodborne disease and occurrences of newly emerging foodborne agents, and to identify and ensure protection of persons at increased or high risk. The Food and Drug Administration, in collaboration with the Centers for Disease Control and Prevention, the Department of Agriculture, colleagues in public health and food control agencies at the state and local level, and other key partners, has updated the Food Code to reflect the most current science and the best strategies to expeditiously ensure a safer food supply in the United States.
The Nation's frontline of defense against the growing, evolving threat of foodborne disease and illness is the uniform, nationwide application of this food safety guidance and regulation based on the best-available science that is embodied in the 1997 Food Code.
David Satcher, M.D., Ph.D.
Centers for Disease Control and Prevention
In the 1994 reorganization of the U.S. Department of Agriculture, Food Safety was elevated to become one of USDA's primary missions, separate and apart from its marketing and promotion functions. USDA's food safety-related functions were consolidated in the Food Safety and Inspection Service (FSIS) under a new Under Secretary for Food Safety. Since then, FSIS has made many changes. These include increased FSIS efforts to assist state and local agencies that shoulder the primary responsibility of enforcing safe food handling, food preparation, and hygiene requirements in America's retail food stores and food service facilities, the last crucial link in the food chain before the consumer.
Perhaps the most notable change has been FSIS's strengthened public health focus and aggressive regulatory actions in dealing with that most significant and most intractable of food safety problems, pathogenic microorganisms. In 1994, FSIS determined for the first time that the mere presence on a food (raw ground beef) of a specific pathogen, E. coli O157:H7, was sufficient to adulterate that food. Then, on July 25, 1996, FSIS published its Pathogen Reduction/HACCP rule. This landmark rule, among other things, demonstrates USDA's commitment to focus primarily on the greatest risks to food safety, those linked with the most frequent and serious foodborne diseases, to make the greatest possible contribution to America's public health.
In keeping with this commitment, we are rededicating ourselves to work closely with other government agencies at the Federal, state, and local levels to do whatever it takes to achieve our common goal--ensuring the nation's food supply is as safe as it can be. FSIS's food safety mandate, like FDA's, extends "from farm to table." FSIS will address safety risks to foods under its jurisdiction as appropriate on the production-through-consumption continuum. It is also important in this era of shrinking government resources for government agencies to work together to ensure efficient as well as effective regulatory oversight of food safety.
FSIS views implementation of the FDA model Food Code and the work of the Conference for Food Protection in recommending changes to the Code as vital to this effort. Food safety in the retail and food service sectors should be available uniformly to all consumers throughout America. Adoption and implementation of effective state and local food laws and regulations are essential to achieving that goal.
FSIS joins with FDA in endorsing and recommending adoption by state and local jurisdictions of this 1997 edition of the FDA model Food Code.
Thomas J. Billy
Food Safety Inspection Service
U.S. Department of Agriculture