About this Newsletter

This is the third issue of HACCP COUNTDOWN. Previous issues highlighted prerequisites to HACCP implementation, including Good Manufacturing Practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs). Sanitation monitoring and record keeping requirements of the U.S. Food and Drug Administrations mandatory HACCP inspection program were illustrated.

This issue focuses on the first formal steps of HACCP: Hazard Analysis and Critical Control Point (HACCP) identification. Questions commonly asked about HACCP and the FDA regulations are also addressed. We will attempt to answer other questions in the future newsletters. Please contact any of the individuals listed on the reverse page with questions or topics needing clarification.

The purpose of HACCP COUNTDOWN is to alert the seafood processing industry of strategies for the successful implementation of HACCP and related food safety programs. We will keep you informed of developments in training and sources of information. These bi-monthly issues highlight topics which, if followed, should prepare for HACCP inspection.

Hazard Analysis

After the company's HACCP team, including HACCP trained individual, reviews the firm's implementation of current Good Manufacturing Procedures (GMPs), it should assess the food safety risks associated with its products and identity preventitve measures (control strategies) for each hazard. This is known as Hazard Analysis. Hazard Analysis will be required when the regulation takes effect on December 18, 1997.

Hazards fall into three categories: biological, chemical and physical (see side bar).

The most accepted approach to hazard analysis is to assess each of the seafood species you handle for known species-related hazards. These are listed in FDA's Fish & Fisheries Products Hazards & Controls Guide. Then consider the effect of each processing step in your operation (including receipt of raw materials) for its effect on hazard introduction, enhancement or control. Processing-related hazards abd example preventive measures are also described in FDA's step (control points) will greatly facilitate hazard analysis.

Not all possible hazards must be controlled, only those which (1) reasonably likely to occur and (2) if not properly controlled, are likely to result in an unacceptable health risk to consumers. Consider the product as it is consumed. Occasional bones in intact fish fillets generally do not require HACCP control, while sizable bones in a portion-controlled sandwich portion may. Bones are a physical hazard only in the latter example because they are unexpected and consequently pose an unacceptable risk.

Of the three hazard groups, microbiological hazards represent the largest category requiring preventive measures in processing plants. Most disease-causing bacteria, viruses and parasites (pathogens) are killed by cooking. Products cooked by the processor and sold ready-to-eat must be controlled with the company's HACCP plan. Those cooked by the consumer often require no HACCP plan. However, exercise caution before dismissing all microbiological hazards in raw seafoods. Common staph bacteria can produce a toxin production which is not destroyed by heat. Check FDA's guide or seek help if uncertain of the minimum conditions required for toxin production. The organisms that cause botulism can be favored by certain conditions controlled by the processor, such as the use of packaging which excludes oxygen. Although botulism toxin is destroyed by very thorough cooking, the disease is extremely hazardous and even a small probability of illness must be controlled in products with heightened risk.

Critical Control Point

A point in the process where an identified food safety hazard can be effectively monitored and controlled is known as a Critical Control Point (CCP). Selection of appropriate CCPs is very important since the monitoring, critical limits, corrective actions, verification and record keeping requirements of HACCP are only required at CCPs.

Critical Control Points are usually established to manage hazards related to (1) product characteristics or (2) processing steps. Examples include ensuring minimum salt and acid levels in a formulated product to prevent pathogen growth, or operating a cooker to meet minimum cook times and temperature.

Common Pitfalls

Designating too many CCPs is a common mistake which dilutes the plan's focus. Processors may identify becterial contamination as a potnetial hazard at virtually every processing step. However, keep in mind that plant sanitation, employee hygiene, handling procedures which prevent cross-contamination, and other GMP-related controls should be a part of the company's SSOP, not its HACCP plan. Assign appropriate CCPs for food safety hazards outside those assiciated with a sanitary environment, such as (1) maintaining histamine-forming fish (e.g. tuna) at a low temperature, (2) checking oysters at receipt foe shellfish tags, and (3) ensuring that a product containing an allergy-triggering ingredient is properly labeles. Conversely, these preventive measures are not appropriate for SSOPa and must be address with HACCP.

Q & A

Q: Since commercial fisherman and common carriers are not covered by the U.S. FDA regulation, am I exempt if I harvest my own fish and use a trucking company to ship them out of state?
A: Proabably not. When you off-load your boat and ice your catch, you perform a processing fucnction and are subject to HACCP inspection.

Q: I've heard that retail chains that have their own distribution centers, like other seafood facilities are not covered by the HACCP regulation. Is this true?
A: No. Grocery store chain distribution centers, like other seafood warehouses, are subject to the regulation.

Q: Do I need to conduct a separate Hazard Analysis for every product?
A: Yes, but it's not as bad as it seems. Screen them initially for species-related hazards then group them by processing method for assessing process-realted hazards. For example, clams, oysters and mussels have similar species hazards and can be grouped. They also have similar process hazards. They can be grouped for stepwise Hazard Analysis through each control point, in fact, they are handled or processed in the same manner.

Q: You say that Hazard Analysis will be required by the regulation but I heard that processors are not required to share it with the inspector. Why do a Hazard Analysis if FDA doesn't require it in writing?
A: You, the processor, must demonstrate an understanding of food safety hazards associated with your products. You also will be responsible for justifying the selection of CCPs and preventive measures usually listed on the Hazard Analysis worksheet. The written Hazard Analysis is evidence that all significant hazards were considered. It supports and rationalizes you HACCP plan.