FDA's Application of HACCP to Retail Food Systems

by

John M. Tisler
Director, Industry Activities Staff
Center for Food Safety and Applied Safety
Food and Drug Administration
Washington, DC 20204

The Food and Drug Administration and other Federal and State food regulatory agencies have found the Hazard Analysis and Critical Control Point (HACCP) technique to be a valuable tool to comprehensively evaluate a food firm's ability to produce safe, quality products. As foo production, distribution, and retail food service systems become more complex, food regulatory agencies are using HACCP as an effective tool to help ensure food safety.

HACCP is being incorporated into FDA's legal requirements that apply to the food industry. Regulations have been proposed that mandate seafood firms operate under HACCP approach. HACCP is also an important focus of the recently developed Food Code which combines previous codes for food service, retail and food vending operations.

FDA recommends that food processing and food service firms seriously consider using HACCP for the evaluation of their operations. Its use allows a firm not only to ensure itself of the production and handling o safe, quality foods, but also to determine its legal compliance and take corrective action before serious problems develop.

FDA believes companies need to develop state-of-the-art quality assuranc plans and government nees to be able to verify that the plans are being carried out. HACCP is an effective way of meeting there criteria

Food Safety and HACCP

The food industry, federal, state and local food regulatory agencies, Congress and state legislatures, and consumers are all concerned that only safe foods of high quality are available.

FDA considers that the primary responsibility for the safety, quality, and other attributes of the food product rests with the processor, distributor, or provider of that food, not the food regulatory agencies. The task of the food regulator is to oversee industry in order to determine whether it is meeting its legally mandated responsibilities. FDA and other food regulatory agencies are very interested in a complimentary responsibility--the improvement of the safety and quality of our food supply, which is already the best in the world (Tisler, 1991).

All Americans need to have confidence in what they eat, whether they eat in a four star restaurant, a supermarket deli counter, a school lunchroom, a hospital, or at home. Whether we eat out or at home, we should not have to wonder if the food has been properly processed, shipped, handled and stored by the retailer under the right temperature.

Since the Hazard Analysis and Critical Control Point (HACCP) concept is an effective quality assurance approach that provides for the evaluation of a food process during its operation, hazards or potential problems that are critical to the food product's safety can be controlled or eliminated as they occur.

The cliché of "building quality and safety into a product, rather than inspecting the finished product for it" describes concisely the HACCP contribution toward food safety. The assurance, and insistence, of food product safety is of paramount importance during every phase of production.

U.S. consumers have the safest food supply in the world. However, a sensational newspaper and television exposé can provide the groundwork of doubt. HACCP is a food safety assurance system that addresses the consumers' concerns that only safe foods be available.

Use of HACCP as an inspectional technique has been shown to provide the regulatory agency with the most comprehensive information about the processing of the food product. Unlike the "snapshot observation-type inspection, HACCP, through its record keeping component, allows for evaluation of the food production process even when the regulator is not in the establishment. Since an effective HACCP-based process is not just a momentary display, it continues to contribute to the food product's safety, even when the regulator is not evaluating the food plant's operation.

Based upon the experience of food firms that have implemented HACCP in some form, and FDA's regulatory experience in the use of HACCP as an inspectional technique, it is concluded that HACCP will:

• Assist industry in producing a safe product;

• Provide assurance to consumers that the U.S. food supply is as safe as possible; and,

• Enable more efficient utilization of government resources in evaluating and auditing the food processing industry (Taylor, 1993).

So where are we so far in this discussion of FDA's application of HACCP to retail food systems? Answer--FDA has concluded that the quality assurance based HACCP approach is a valuable tool in food safety improvement. Having said that, it might be helpful to briefly discuss where the HACCP technique fits into FDA's plans to not only assure the safest food supply in the world, but improve its safety.

FDA's Food Safety Initiatives

FDA's food safety initiatives have three basic components. They are:

• The mandatory use of the Hazard Analysis and Critical Control Point (HACCP) principles throughout the seafood industry;

• The exploration of the use of HACCP as a requirement for the rest of the food industry; and,

• The development of a model Food Code--a set of uniform federal recommendations, a major part of which is the use of HACCP in retail food systems, to local, state, and federal agencies that inspect retail level food operations.

These food safety initiatives do indeed incorporate the HACCP approach as one of their keystones. Why? Because of what it is and does. HACCP is an internationally recognized, state of the art, science based system that was first used by the food industry in the production of safe food for the U.S. astronauts. It was applied to and has been very successfully used by the canning industry for over 20 years.

HACCP has gained recognition throughout the developed world as the best safety assurance system developed to date. It has been recommended by the National Academy of Sciences and the World Health Organization's Codex Alimentarius committee as an effective and workable approach to food safety control. In addition, the European Community and many developed nations have adopted HACCP for their seafood products, or are in the process of doing so (Billy, 1994).

HACCP for the Seafood Industry

FDA's seafood HACCP proposal applies to all domestic commercial processors of seafood products, including processors, repackers, and warehouses. Imports also fall into this regulation, in that all foreign processors shipping product to the U.S. will have to meet the same requirements.

U.S. importers will be required to develop and implement their own HACCP plans, which include copies of the HACCP plans of their foreign processors. Importers will have to describe what they are doing to assure that the products they are bringing into the U.S. have been produced in accordance with the foreign processor HACCP plans - that is that the foreign processor's HACCP plans were working effectively when the product was produced.

FDA's seafood HACCP proposal has generated many helpful and constructive comments from industry, consumers and other government agencies. These comments are currently being assessed and will be addressed in the final regulation. The best estimates for its issuance is for the summer of 1995, with an effective date of a year later.

Mandatory HACCP for all of the Food Industry

The second element in FDA's new food initiatives is to determine the appropriateness of requiring the use of the HACCP technique, as an additional safety assurance, throughout the entire food industry.

FDA's consideration of this use of HACCP is based upon the benefits that will accrue for the consuming public, the food industry, and the government regulator.

FDA has been working with other segments of the food industry, state officials and consumer groups to consider whether preventative food safety measures can be applied to other foods. Like the approach that is being taken with the seafood industry, such measures would have to be tailored to the nature of the potential hazards for each food and to the operations of the affected industry.

Among the topics that need to be addressed in the development of the HACCP approach for other food industries are:

• Where do the food safety hazards exist for a particular product;

• At what points could these hazards be minimized or eliminated;

• What are the most effective, and efficient, methods to monitor compliance; and,

• How do the laws and regulations of other countries impact upon the use of HACCP in the production of foods imported into the U.S. and U.S. food products exported to other countries?

This "universal HACCP" is still in the preliminary stages, and more information about it will become available as development progresses.

The Food Code

The third of FDA's new food safety initiatives directly applies HACCP to retail food systems. It is the Food Code.

The Food and Drug Administration has published the 1993 edition of the Food Code. It is a reference that guides retail outlets, such as restaurants and grocery stores and institutions such as nursing homes, on how to prepare food to prevent foodborne illness.

Provisions of the new Food Code are compatible with the HACCP concept and terminology in identifying and monitoring the critical points in retail food preparation where the risks of food-borne hazards--microbial, chemical and physical, are greatest.

Local, state and federal regulators use the FDA Food Code as a model to help develop or update their own food safety rules and to be consistent with national food regulatory policy. Also, many of the over 1 million retail food establishments apply Food Code provisions to their own operations. Although the Food Code is neither federal law nor federal regulation and does not preempt state or local laws, authority to provide such guidance is granted by federal law.

The new code updates and combines into a single document three former editions that separately covered food service establishments (such as restaurants), food vendors, and food stores. Previous editions of the code were 1982 for food stores, 1978 for food vendors, and 1986 for food service.

Prevention of food-borne illness, the primary focus of the new food code, is emphasized in several modifications and new provisions. These include:

• Detailed charts that give specific guidance for time, temperature and humidity for cooling meat and other raw foods derived from animals. For example, ground meat must be cooked to an internal temperature of 155 degrees Fahrenheit (68 degrees Celsius) for 15 seconds to be safe. Cold holding temperature is 41°F (5°C or lower);

• Recommendations to retail manager on how to ensure food service workers' health and hygienic practices (including restricting infected employees), how to clean and sanitize food utensils, and how to maintain equipment and facilities In order to comply with the Food Code, retail management will have to be able to demonstrate knowledge of food-borne illness prevention as it relates to their own food operation.

New to the 1993 Food Code are provisions for:

• Setting time limits for holding cooked foods safely outside of controlled temperatures;

• Allowing the temperature of frozen foods to be raised, short of thawing, before cooking, which is sometimes desirable for improving the texture of cooked foods;

• Using food additives safely;

Other features are:

• Marking the date of preparation on all potentially hazardous refrigerated ready-to-eat foods that are prepared and held for more than 24 hours in a food establishment;

• Preparing wild game, exotic animal species, and wild mushrooms;

• Ensuring honest presentation of foods to consumers; and,

• Advising consumers that certain foods should be ordered and eaten fully cooked in order to ensure their safety.

The new Food Code also has expanded provisions for the safety of molluscan shellfish, such as oysters, clams and mussels (Elliot, 1994).

Work on the new Food Code began at the request of the Conference for Food Protection after consultation with several professional and trade associations. The conference is a group of representatives from regulatory agencies at all levels of government, the food industry, academia, and consumer organizations that works to improve food safety at the retail level.

FDA, other government agencies, and food industry representatives identified and prioritized needed changes and additions to the existing codes and eliminated redundancies and inconsistencies. The proposed food code was published in the May 9, 1988, Federal Register, and FDA received comments from over 150 agencies and organizations. The draft was modified based on the comments, and the Food Code was published in final form in January 1994. It will be updated every two years.

HACCP in the Food Code

The application of HACCP in the Food Code follows the direction established by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) in 1988. NACMCF has as members, representatives of federal and state government, academia, the food industry, and consumer groups. The NACMCF developed seven widely accepted HACCP principles that explain the process in great detail. To prepare an effective HACCP plan for retail food operations, these principles must be faithfully followed.

These seven principles comprehensively address hazard analysis, critical control point identification, monitoring procedures, corrective action procedures, verification, and record keeping.

The Food Code discussion of the implementation of HACCP of retail food systems goes into detail about the specific operations of each of these principles. I recommend that you obtain a copy of the Food Code for this additional information.

The preceding discussion of HACCP use in retail food systems as presented in the Food Code can be viewed from two perspectives.

If you are a food regulator, you may have concluded that a HACCP system allows a regulatory agency to more comprehensively determine an establishment's level of compliance.

The reasons for this conclusion are apparent.

First, HACCP plan clearly identifies the food establishment as the final party for assuring the safety of the food it produces. HACCP requires the food establishment to analyze its preparation methods in a rational, scientific manner in order to identify critical controls and to establish critical limits and monitoring procedures. A vital aspect of the establishment's responsibility is to establish and maintain records that document adherence to the critical limits that relate to the identified critical control points, thus resulting in a "continuous self-inspection."

Secondly, a food establishment's use of HACCP requires development of a plan to prepare safe food. This plan must be shared with the regulatory agency because it must have access to monitoring records and other data necessary to verify that the HACCP plan is working. Using conventional inspection techniques, an agency can only determine conditions during the inspection that provide a "snapshot" of conditions at the moment of the inspection.

However, by adopting a HACCP approach, both current and past conditions can be determined. When regulatory agencies review HACCP records, they have, in effect, looked back through time. Therefore, the regulatory agency can better assure that processes are under control.

If you are in the retail food industry, your conclusions may be similar, but from your point of view, about the benefits of HACCP to your operation.

A HACCP system emphasizes the industry's role in continuous problem solving and prevention rather than relying solely on periodic facility inspections to be regulatory agencies, or "after the fact" information.

It is a systemic approach which will dramatically improve the level of foods offered to the consumer throughout the retail food system.

Implementation of HACCP programs by retail food establishments will profoundly enhance their role in the protection of public health beyond the traditional emphasis on facility and equipment design and maintenance and adherence to the principles of sanitation, good manufacturing, and food preparation.

The education and training of all personnel are critical to the success and effectiveness of any HACCP program.

Because the retail food establishment industry is composed of large, small, chain, and independent operations, the level of food safety varies widely and is not necessarily linked to size or affiliation. Regardless of the size and sophistication of the establishment, a plan for safe food preparation and sales needs to be in place. The HACCP principles offer this opportunity.

Retail HACCP is "Pilot Tested"

FDA has "pilot tested" the use of HACCP at the national retail food level in two activities. The purpose of these pilot programs was:

• To promote HACCP and HACCP plan development in the retail Seafood and retail food service areas;

• To effectively train industry personnel to develop acceptable and achievable HACCP plans;

• To train regulatory food officials in the review and approval process of HACCP and the inspection approach of HACCP plans in operation; and,

• To test a federal oversight approach that assists local and state regulatory food agencies in their administration of voluntary HACCP programs.

The first pilot program--HACCP use in retail seafood--was conducted in cooperation with the National Marine Fisheries Service (NMFS). It involved 12 companies in 11 states, and 22 stores participated during November, 1992 through March, 1993. The specific area of concern was the seafood counter in the store. HACCP principles were applied and the store, FDA and NMFS monitored the operation.

The results of this use of HACCP in the retail seafood area showed that:

• A physical separation was necessary to prevent cross contamination between raw, cooked, and ready-to-eat products;

• Temperature recording made store personnel aware of the amount of product to maintain on display in order to maintain the desired safe temperature;

• All stores had written and complied with their HACCP plans by the end of the pilot;

• 40°F was achievable for refrigeration; and,

• There was a greater awareness of product quality and their ability to help assure it by personnel.

The use of the HACCP approach to food safety and quality in restaurant operations was the second pilot program area. Twelve individual restaurants in 11 states participated. A complex and a simple food preparation recipe was used in each location. After training sessions, the pilot test ran from March, 1993 through September, 1993. Simulated regulatory inspections covered validation of the HACCP plan, state agency verification and federal regulatory verification.

The restaurant HACCP pilot program showed that:

• Restaurant personnel could develop and implement HACCP plans, but it was more difficult than experienced in the retail food store pilot program; and as was found in that program;

• 40°F was achievable for refrigeration and there was a greater awareness of product quality and the ability to help assure it by establishment personnel.

These pilot programs suggested a serious interest in the development of a cooperative, comprehensive voluntary HACCP program with procedures, standards, methods, and a national listing.

FDA has also begun discussions with the National Restaurant Association to test HACCP use in restaurants, and the In Flight Food Service Association to use the HACCP approach with the preparation and handling of food served aboard aircraft.

HACCP as Self-Inspection

Understanding the applicable legal requirements as well as its own specifications, a food establishment can effectively use HACCP as its self-inspection--a complimentary effect of operation under a HACCP plan.

This allows the firm, not only to assure itself of the production of safe, quality foods, but also to determine its legal compliance, and take appropriate corrective action, before the regulatory agency must initiate its legal actions, or the firm's reputation with its consumers becomes jeopardized.

FDA recommends the implementation of HACCP in food establishments because it is a system of preventative controls that is the most effective and efficient way to assure that foods are safe.

At the introduction of FDA's new food safety initiatives in January of 1993, FDA Commissioner David Kessler told the food industry, "This system of mandatory controls (i.e.; HACCP) draws its strength from one simple principle: the notion that the best way to provide safe, high quality foods is to build safety in during processing." He went on to say, "Today, we inspect for safety after the fact. That's simply not good enough. We need to approach food safety by preventing problems up front" (Kessler, 1994).

FDA believes food companies in every area of food processing, food distribution, and food service, need to develop state of the art food safety plans and the regulatory agencies must be able to verify that the plans are being carried out.

HACCP is an effective way of meeting these criteria.

References

Billy, T.J. 1994. FDA's food safety initiatives. Presented at the Town Meeting on HACCP. Boston, Mass., Mar. 16.

Elliot, E. 1994. The food code. Presented at FDA's New Food Code Initiatives meeting. Miami. Fla. Mar. 3.

FDA. 1994. The Food Code. Food and Drug Administration. Washington, DC.

Kessler, D.A. 1994. Remarks. Presented at Food Safety news conference. Washington, DC. Jan. 21.

Tisler, J.M. 1991. The Food and Drug Administration's perspective on HACCP. Food Technol. 45(6), 125.

Taylor, M.R. 1993. FDA's plans for food safety and HACCP--institionalizing a philosophy of preventation. Presented at the Symposium on Foodborne Microbial Pathogens. Atlanta, Ga. Aug. 3.