ISSUE 4

This issue focuses on HACCP steps 3 and 4: establishing Critical Limits and Monitoring procedures at CCPs. Questions commonly asked about HACCP and the FDA regulation are also addressed. Please contact any of the individuals listed on page two with questions or topics needing clarification.

The purpose of HACCP COUNTDOWN is to alert the seafood processing industry of strategies for successfully implementing 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 processors for HACCP inspection.

Setting Critical Limits

A Critical Limit (CL) represents a specific condition which must be met to ensure food safety. One or more Critical Limits must be established to control the significant hazards identified at each Critical Control Point. Examples include (1) maximum or minimum temperature, (2) holding time, (3) presence of a fully completed shellfish tag, and (4) brine concentration for smoked fish processing. From these examples we see that some CLs are measurements (brine salometer reading) while others may be a visual check for presence/absence (shellfish tag). Critical Limits should be readily monitorable and not require extensive testing of the product. Consult FDAs Fish & Fishery Products Hazards & Controls Guide, food laboratories, consultants or university specialists if in doubt of appropriate CLs. When the process deviates from the CL, an appropriate Corrective Action must be taken.

Monitoring

Monitoring is a planned schedule of observations or measurements used to determine whether a CCP is under control and to produce a record for verification. Monitoring allows for tracking a process and identifying trends toward a CL. This permits an operator to make process adjustments prior to a deviation. Monitoring procedures must identify (1) what will be monitored, (2) how the CLs and preventive measures for food safety will be monitored, (3) how frequently monitoring will be performed, and (4) who will monitor. Monitoring examples include periodic checks to ensure that each preventive measure associated with a Critical Limit is in place (e.g., checking thermometer readings or a clock for elapsed time).

Common Pitfalls

1. Setting a single Critical Limit when two or three are better. If pathogenic bacteria of concern are best controlled by holding product below 40 degrees F, a CL of 40 degrees F for the cooler may seem appropriate. However, it is likely to be unmanageable in practice since the CL will be violated whenever the door is opened for loading or shipping. A spike in cooler temperature does not create an unsafe product immediately and no Corrective Action should be necessary. Critical Limits established for both temperature and time above that temperature provide more information and minimize unnecessary corrective action.
   
   
2. Setting two or more Critical Limits when one is better. Remember you must be able to consistently monitor CCPs to determine if the CL is being approached, then take an appropriate corrective action if the CL is exceeded. Let's say we set CLs of time above some critical temperature, e.g., more than 2 hours above 50 degrees F for a pre-chilled ready-to-eat product during processing. This would require repeated checking of product temperature to determine not only if 50 degrees F is exceeded but for how long it is exceeded. A simpler approach may be to limit room temperature exposure to 2 hours: a single CL which is more readily monitored. If you could show through in-plant study that the product remains below 50 degrees F even if out of refrigeration for 3 to 4 hours, then an exposure time longer than 2 hours would be acceptable.
   
   
3. Setting a Critical Limit based on industry practice rather than food safety hazards. If pathogens of concern are destroyed at 170 degrees F, there is no need to set a minimum product temperature CL of 225 degrees F just because it is readily attained in a pressure-cooked product.
   
   
4. Setting a Critical Limit which can only be monitored with difficulty or after the fact, e.g., temperature of product exiting a cooker as in pitfall #3. This type of check is usually conducted periodically, typically by quality control staff (not always an option for small companies). And significant quantities of product may require recooking or holding for additional testing if the CL is not met. Using this example, a better approach is to set CLs for cooker operating temperature and time (e.g., belt speed) which are shown to achieve the necessary product temperature. This way, the equipment operator can make frequent observations and adjustments as needed, often avoiding a CL deviation. Also, records of these observations more fully identify the source of problems when they occur. For example, was the cooking time too short or the cooker too cool?

Q & A

Q: Commercial fishermen are exempt from the federal HACCP regulation. I have heard conflicting opinions about when a commercial fisherman becomes a processor under this regulation. Does off-loading a boat or boxing fish require compliance with the regulation?
A: The U.S. FDA is currently preparing an official response to this and similar questions. Our most recent understanding is that watermen who handle their own fish generally are not expected to comply, even if they box, ice and transport fish for retail or wholesale delivery. If they buy from other suppliers, consolidate shipments like a distributor, or hold seafood for an economic advantage they most likely will be responsible for HACCP.

Q: Is the exemption also true for soft-crab producers who shed their own peelers?
A: No. FDA currently views crab floats as holding facilities which are covered by the regulation. This is consistent with their policy requiring HACCP for wild-caught lobsters held in pounds.

Q: Is it true aquaculturists are exempt from the regulation?
A: In a recent letter, the FDA clarified its position which exempts aquaculture producers from the regulation to the same extent as commercial fishermen described in the first Q/A.

Upcoming HACCP Courses in Maryland/Virginia Area

(National Seafood HACCP Alliance, certified by the Association of Food and Drug Officials):

ISSC Course

The Interstate Shellfish Conference recently announced a one-and-a-half day course for a shellfish shippers and reshippers (those firms having a license beginning with SS ir RS). This shortened course complies with the training requirement of the U.S. FDA HACCP regulation, but only for these two seafood business categories. We will offer the following ISSC-certified course this fall:

For Information and Assistance

HACCP courses nationally, HACCP models and HACCP links are available on the Internet: http://www-seafood.ucdavis.edu/

For information and assistance on the subject of HACCP, contact the seafood specialist
in your state:

David Green, North Carolina State University, (919) 726-7341
George Flick, Virginia Tech, (540) 231-6965
Tom Rippen, University of Maryland, (410) 651-6636