White Paper: Fda Food Quality And Haccp

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FDA Warning Letters Focus on HACCP Issues Still not sure if the Food & Drug Administration is interested in Hazard Analysis and Critical Control Point, or HACCP? Well, as one politician might say to an opponent during a debate, “Let’s look at the record.” The FDA has already issued nearly 30 HACCP – pronounced “hassip” -- warning letters issued through the first four months of 2006. That accounts for the bulk of the food-related warning letters issued by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and other offices. But that shouldn’t be surprising. In 2005 HACCP warning letters accounted for more than 80 of the approximately 100 issued by the agency. The pattern was similar in 2004, when more than 100 of the approximately 130 food-related warning letters focused on HACCP. In fact, HACCP warning letters tend to account for about 80% of those issued each year by the FDA’s CFSAN and food-related letters from other offices. And you’ll have a long search indeed if you are looking for an expert to tell you that that pattern is likely to change anytime soon. Clearly, HACCP remains a significant part of the FDA’s food enforcement focus. Now that we’ve established that HACCP is important to the FDA and its inspectors, let’s take a quick look at what those inspectors expect to find at a regulated site.

FDA Embraces HACCP “Space-age technology designed to keep food safe in outer space may soon become standard here on Earth,” the agency declared back in October 2001 when it significantly expanded the HACCP program. The FDA adopted this food safety program developed nearly 30 years ago for astronauts and is applying it to seafood and juice. The agency intends to eventually use it for much of the U.S. food supply. The program for the astronauts focuses on preventing hazards that could cause food-borne illnesses by applying science-based controls, from raw material to finished products. FDA’s new system will do the same. Traditionally, industry and regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. This approach, however, tends to be reactive, rather than preventive, and can be less efficient than the new system, the FDA says. HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius Commission (an international food standard-setting organization), and the National Advisory Committee on Microbiological Criteria for Foods. A number of U.S. food companies already use the system in their manufacturing processes, and it is in use in other countries, including Canada.

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c o m p l i a n c e What is HACCP? HACCP involves seven principles: n Analyze hazards. Potential hazards associated with a food and measures to control those hazards are identified. The hazard could be biological, such as a microbe; chemical, such as a toxin; or physical, such as ground glass or metal fragments. n Identify critical control points. These are points in a food’s production--from its raw state through processing and shipping to consumption by the consumer--at which the potential hazard can be controlled or eliminated. Examples are cooking, cooling, packaging, and metal detection. n Establish preventive measures with critical limits for each control point. For a cooked food, for example, this might include setting the minimum cooking temperature and time required to ensure the elimination of any harmful microbes. n Establish procedures to monitor the critical control points. Such procedures might include determining how and by whom cooking time and temperature should be monitored. n Establish corrective actions to be taken when monitoring shows that a critical limit has not been met--for example, reprocessing or disposing of food if the minimum cooking temperature is not met. n Establish procedures to verify that the system is working properly--for example, testing time-and-temperature recording devices to verify that a cooking unit is working properly. n Establish effective recordkeeping to document the HACCP system. This would include records of hazards and their control methods, the monitoring of safety requirements and action taken to correct potential problems. Each of these principles must be backed by sound scientific knowledge: for example, published microbiological studies on time and temperature factors for controlling foodborne pathogens.

Need for HACCP New challenges to the U.S. food supply have prompted the FDA to consider adopting a HACCP-based food safety system on a wider basis. One of the most important challenges is the increasing number of new food pathogens. For example, between 1973 and 1988, bacteria not previously recognized as important causes of food-borne illness--such as Escherichia coli O157:H7 and Salmonella enteritidis--became more widespread. There also is increasing public health concern about chemical contamination of food: for example, the effects of lead in food on the nervous system. Another important factor is that the size of the food industry and the diversity of products and processes have grown tremendously--in the amount of domestic food manufactured and the number and kinds of foods imported. At the same time, FDA and state and local agencies have the same limited level of resources to ensure food safety. The need for HACCP in the United States, particularly in the seafood and juice industries, is further fueled by the growing trend in international trade for worldwide equivalence of food products and the Codex Alimentarious Commission’s adoption of HACCP as the international standard for food safety.

HACCP Advantages HACCP offers a number of advantages over the current system. Most importantly, HACCP: n focuses on identifying and preventing hazards from contaminating food n is based on sound science n permits more efficient and effective government oversight, primarily because the recordkeeping allows investigators to see how well a firm is complying with food safety laws over a period rather than how well it is doing on any given day n places responsibility for ensuring food safety appropriately on the food manufacturer or distributor n helps food companies compete more effectively in the world market n reduces barriers to international trade.

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c o m p l i a n c e How FDA Inspectors Work There is some good news for FDA-regulated firms out there wondering how to get in the shoes of an FDA Inspector: The agency publicly publishes the instructions it gives to inspectors. For food-related inspections, the FDA tells inspectors, “Regardless of the resource limitations you may have, you can still use the principles of HACCP to guide your inspections.” The agency defines “hazards” as the specific biological, chemical, or physical properties or agents that, if uncontrolled, may lead to illness or injury. Risk factors are the poor conditions, procedures, or practices that result in out-of-control food safety hazards.

Risk factors include n Food from Unsafe Sources n Inadequate Cooking n Improper Holding Temperature n Contaminated Equipment n Poor Personal Hygiene

Focus of Risk-Based Inspections “Conducting a risk-based inspection requires you to focus on evaluating the degree of active managerial control that an operator has over risk factors,” the agency instructs inspectors. “In order for you to properly assess active managerial control, you will need to spend the majority of your time observing the practices and procedures that are likely to lead to out-of-control risk factors and asking food workers questions to assess the operation.”

CFSAN’s ROLE IN FOOD SAFETY The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety and security of about 80% of the U.S. food supply. It is responsible for cosmetics, too. However, meat and poultry do not come under its jurisdiction; those are regulated by the U.S. Department of Agriculture.

Retail and food service operators implement “control measures” to ensure food safety. Control measures are actions or activities that are used to prevent, eliminate, or reduce food safety hazards. Instructors are told they’ll need to determine the control measures Since 9/11, CFSAN has ramped up its that should be implemented to prevent the occurrence of risk efforts to protect the nation’s food factors in each food preparation process. “In order to determine supply from terrorism. Much of its work in this area centers on the Bioterrorism the risk factors common to each operation, it is important for you Act of 2002. In 2005, the FDA published to understand that the food preparation processes and all the the final rule requiring registration of all associated control measures initiated by a retail or food service domestic and foreign facilities providing operator represent a food safety management system. It will be food and feed for the U.S. market. Some necessary for you to ask questions in order to gain information 116,000 domestic and 155,000 foreign about the system already in place. Once you have done this, you facilities have already complied with the will be able to determine the degree of active managerial control requirement. present in the facility and will be able to assist the operator in strengthening the system.” By setting priorities early in the inspection, observations attributed to out-of-control risk factors can be distinguished from those related to general sanitation and maintenance, the agency tells its inspectors. They are advised to set priorities by completing four activities early in their inspection: n Establishing an open dialogue with the person in charge n Reviewing previous inspection records n Conducting a menu or food list review n Conducting a quick walk-though

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c o m p l i a n c e Inspectors Look for the Boss Remember: If you are in charge, the FDA inspector is likely to train their sites on you. “Having an open dialogue with the person in charge during all phases of your inspection gives you an opportunity to learn important information about the existing food safety management system,” the FDA instructs its inspectors. “It is important to know both the strengths and weaknesses of the existing food safety management system early in your inspection so that you can focus your inspection on weak areas.” Asking the person in charge questions about important activities such as receiving, cooling, and preparation is also important in relating the seriousness of out-of-control risk factors, the FDA tells inspectors.

Reviewing Previous Inspection Reports And FDA inspectors will carefully examine your compliance record before they make a site visit. “If the same risk factor is out-of-control during more than one inspection, it is strongly recommended that the operator develop an intervention strategy to prevent its recurrence. Knowledge of what has been corrected from the last inspection also gives you the opportunity to provide some positive feedback to the operator and allows you to track corrected violations in accordance with your jurisdiction’s policy.”

Conclusion The FDA makes it crystal clear that HACCP is critically important. As we have seen, it is one of the first issues an inspector will focus on during an inspection. The evidence is obvious; the vast majority of food-related warning letters issued by the agency focus on HACCP. It’s been that way for years and isn’t likely to change any time soon. It is equally important for FDA regulated entities to understand HACCP and develop a proactive, strategic compliance plan for their operation. That means developing a plan, identifying the tools and committing to training your people to help your company avoid the sting of an FDA warning letter.

RESOURCES: m The FDA has an excellent HACCP overview available for download at:

http://www.cfsan.fda.gov/~lrd/haccp.html

m The FDA’s “Playbook” for Inspectors, “Managing Food Safety: A Regulator’s Manual For Applying HACCP Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems,” is available at:

http://www.cfsan.fda.gov/~dms/hret3toc.html

m To keep up with the latest warning letters and spot any new enforcement trends, go to the FDA’s warning letter database at:

http://www.fda.gov/foi/warning.htm

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