Hazard Analysis
Hazard analysis in a food plant is the first step in creating a Hazard Analysis and Critical Control Point (HACCP) plan. As most people know, HACCP has become the industry standard approach to ensuring food safety. It is actually mandated by federal regulation in certain industries, such as seafood, juice, and meat and poultry.

Several authorities on food safety and HACCP have pointed out that simply having a HACCP plan is not sufficient to guarantee safe food. Herb Weinstein, a consultant in suburban Washington, D.C. (phone 703-812-8513), has extensive international experience from a long career with General Foods and his more recent consulting. He has seen, in developing countries especially, that HACCP plans can be misapplied. For example, a HACCP plan in the absence of Good Manufacturing Practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs) will not be effective. (IFT has produced a CDROM entitled “Prerequisite Programs for HACCP: You Can’t Start HACCP without Them” that addresses this issue.)

Weinstein also pointed out that employee sabotage can be a challenge to prevent. In one case he described, small bolts were being found in frozen novelties made in a plant in Brazil. Investigation determined that maintenance workers were leaving their tools and supplies unattended in the plant and that this was the source of the potentially harmful foreign matter. Removing the source, in this case, eliminated the problem.

Foreign Matter
Rick Stier, a consulting food scientist in Sonoma, Calif. (phone 707-935-2829), discussed the issue of foreign matter as a hazard and also the issue of outsiders mandating Critical Control Points (CCPs). Foreign matter may be a physical hazard, depending on the product and the results of the hazard analysis. Possible sources may be the agricultural field, the processing plant, the distribution system, or intentional contamination. The twelve most commonly identified foreign substances in food are, according to Stier, glass, metal, stones, wood, jewelry, insects, insulation, bone, plastic, personal effects, bullets, and needles. Any of these could, in principle, cause injury, but there are sensible provisions and/or unit operations in the process that can be taken or installed to avoid or remove them.

For example, food processing systems almost always have a cleaning step to remove field debris, such as stones, dirt, and small animals. Dry processes have several stages of screening to remove foreign matter. Stier feels that wood, stones, and insulation are so rarely found in foods that they do not represent a serious hazard. The unit operations alluded to above will almost always eliminate such materials.

Assessing the relative risk is an important practice in establishing a HACCP plan so that attention is focused where it is needed. Bullets and needles are found in meat as a result of careless or malicious hunters and of animals flinching as they are inoculated. Manufacturers of veterinarian supplies make their needles of easily detected metal so this hazard can be found and removed.

Plastic contamination, which can occur from drum liners and other packaging, is addressed by using colored plastic. Blue is suggested because few foods are blue, so visual inspection can find pieces of plastic.

Personal effects and jewelry are normally removed by workers and visitors to avoid loss into food. Many companies do not permit breast pockets on work gowns because of the potential for things to fall into product when the employee bends over. Employees carry pens, thermometers, and watches in scabbards at their waist or in inside pockets. Bandages, if they must be worn, should be colored so they can be spotted. Some plants require wearing gloves over bandages on hands.

Finally, Stier agrees with Weinstein on the issue of intentional contamination. He strongly recommends good management practices and employee education. He points out that the workers on a line generally know what is happening. If they understand that their livelihood depends on the production of safe food, they may deter the actions of a disgruntled colleague. Making the work environment safe and comfortable helps also to reduce the temptation to exact revenge on the company.

Mandated Critical Control Points
Both Stier and Rosemary Mucklow, Executive Director of the National Meat Association, Oakland, Calif. (phone 510-763-1533), are concerned about mandated CCPs. The original HACCP concept relied on those closest to the process to identify the potential hazards and the relevant control points. As the approach has been adopted by regulatory agencies such as the Food and Drug Administration and the U.S. Dept. of Agriculture, inspectors have been refusing to accept HACCP plans that do not conform to their preconceived ideas.

For example, FDA has required that there be a CCP at receipt of bulk shelf-stable juice or high-Brix concentrate which is to be repackaged at a site different from where they were pasteurized or sterilized. A guidance document issued in April 2003 (www.cfsan.fda.gov/~dms/juicgui8.html) gives very specific “suggestions” about CCPs and procedures. Apparently these arose from at least one instance of contamination that occurred when a sealed bulk load was opened incorrectly.

The normal practice in the juice industry has been to pasteurize bulk juice even though it has been previously sterilized. Juice that has been heat treated does not pose a health hazard, though fresh juice has been implicated in some foodborne illnesses. Those incidents led to the requirement of a five-log reduction in target pathogens. Heat treatment is the easiest way to conform, but other approaches are acceptable, such as vigorous surface cleaning (for citrus fruit), high pressure, and pulsed electric fields.

Mucklow, on behalf of the meat industry, is concerned about the “zero tolerance for visible fecal matter” requirement for meat. While obviously undesirable, fecal matter is not the real hazard in meat. Invisible microbes, such as Salmonella, Listeria monocytogenes, and Escherichia coli O157:H7 are the hazards, and are not found by visual inspection. Mucklow also points out that her industry does not produce a sterile final product in fresh meat. Meat is intended to be cooked before eating.

Consumer advocates worry that education of food preparers can never be so effective that all hazards are eliminated. Thus, there is a tension between the industry, which wants to produce as safe a product as possible, and those who want some absolute guarantee of safety.

Kerri Harris, Executive Director of the International HACCP Alliance in College Station, Tex. (phone 979-862-3643), points out that there have come to exist three types of HACCP: scientific HACCP, government HACCP, and customer HACCP.

Scientific HACCP is the original, which uses those close to the process to identify hazards, assess risk, and identify critical control points. A CCP is not very useful unless something can be measured and steps taken to correct deviations.

Government HACCP, as previously mentioned, has become a regulatory tool in which some CCPs are mandated, whether they would have been identified under a scientific approach or not. In the case of the zero-tolerance rule, for example, it is permitted to steam-pasteurize or trim away visible contamination. This does not necessarily address the invisible contamination that may or may not exist. Some meat packers are routinely adopting carcass surface pasteurization, but then measures must be taken to ensure that recontamination does not occur.

Customer HACCP occurs when a buyer insists that a supplier have a HACCP plan in place and that it include certain CCPs. A common one is metal detection, which is, in fact, quite common but may or may not actually represent a CCP under the scientific approach. As Stier pointed out, the normal operation of the process may ensure that most foreign matter is removed, so further checking might not be required. However, to satisfy a customer, most manufacturers will comply.

The problem with proliferation of CCPs, according to John Norback, Professor of Food Science at the University of Wisconsin and also principal of Norback, Ley LLC (phone 608-263-4949), is that the resulting HACCP plan can become cumbersome to manage. Norback has developed software to help prepare HACCP plans in a systematic way. He particularly emphasizes assessing risk. For example, he points out that a small exposure to Listeria is not dangerous to healthy adults but can be fatal to unborn children, the elderly, and those with compromised immune systems. Whether measures to prevent or remove Listeria contamination are critical may depend on who is the target consumer for a given product. However, there is in practice a zero tolerance for Listeria in most foods.

Proper Design is Key
All of the authorities consulted for this article emphasized that proper process design is the key to hazard prevention and removal. All agreed that prevention of contamination is the first choice. Good judgment is necessary in assessing risk and focusing on correct priorities. Controlling access to unprotected food while providing opportunities for visual inspection is a challenge.

Finally, any HACCP plan is dynamic. One of the critical steps is verification that it is working. As Stier said, if the HACCP documents are dusty, that is a good sign that it has not been revisited and adapted to changing circumstance.

Contributing Editor
Consultant to the Process Industries
Oak Park, Ill.