FDA`s HACCP Program Mandates Safe Seafood
By Susan English
Rockville, MD–The FDA is pushing to mandate its proposed regulations requiring processors and importers of seafood to install and implement HACCP systems by the end of this year. HACCP (Hazard Analysis Critical Control Point) is a preventive system of hazard control used throughout the food industry. Its primary purpose in the FDA`s new seafood safety program is to help members of the commercial fish and fishery products industry identify and control potential hazards associated with the products they handle and process.
The seven-step HACCP process was developed to replace end-product testing as a way of controlling safety: hazard analysis, identification of critical control points, establishment of critical limits, monitoring critical control points, establishing corrective action, effective recordkeeping, and establishing procedures for verification. They were developed by the National Advisory Committee for Microbiological Criteria for Foods (NACMCF), a committee established by the U.S. Department of Agriculture with the FDA and at the recommendation of the National Academy of Sciences. Proposed regulations were published in the Federal Register of January 28, 1994, and the comment period ended in May of this year.
Accompanying the finalized regulations is the FDA`s Fish and Fishery Products Hazards and Controls Guide, which sets forth controls and practices to assist federal and state regulatory officials in developing uniform and consistent regulatory strategies and controls, helping them to evaluate individual HACCP plans. The FDA has gone through a “very lengthy and exhaustive process” of reading and analyzing over 250 comments received, and is using them to make policy decisions on the final regulation, expected out by the end of this year, according to FDA Acting Director of the Office of Seafood, Phil Spiller. “I think there`s a real confluence of interests here. We have been persuaded for some time now that HACCP is the most efficient and effective system we can have, especially for seafood; and more and more, the industry is feeling that it will provide them credibility with U.S. consumers and also internationally. Many other nations, including the European community, are opting for HACCP systems, so it`s really becoming a sort of international standard.”
To a relatively small, but growing, segment of the seafood industry, the new HACCP regulations will come as no surprise. Many of those companies already have put HACCP safety practices in place by joining the Department of Commerce`s voluntary, fee-for-services HACCP-based food safety program. The IQA (Individual Quality Assurance) program, established several years ago, applies the FDA`s HACCP principles, visits food processors who have bought their services, and conducts voluntary inspections. In the past, seafood processors who did not have their own quality control departments could hire the Department of Commerce to act as a sort of “surrogate quality control department,” which could include a “virtually continuous inspector presence,” says Spiller. Some large firms, however, have their own in-house quality control programs. One such firm is the Boston-based restaurant Legal Sea Foods, which actually has its own microbiology laboratory and was a member of the first FDA/USDC certified HACCP inspection program.
Legal`s Director of Quality Control/Quality Assurance, Stephen Martinello, is a registered sanitarian. Every day, he checks each lot of shellfish coming into the restaurant, quarantining it, tagging and testing it for release the following morning, only if the lot checks out against the battery of tests he has devised to weed out any suspect crustacean. One of the tests, the rapid A-1 fermentation test, is actually designed for testing seawater, but Martinello has tailored it for testing shellfish, even though it means that some safe fish may be rejected in the process. He says he would rather risk losing a few perfectly good fish than run the risk of accepting unsafe fish. Other tests, such as aerobic plate counts, coliform counts, staph, listeria and histamine, are conducted weekly, and in many cases, exceed FDA or HACCP requirements.
Martinello looks forward to the new, flexible HACCP plan, because it lets companies determine their own methods for implementing HACCP principles instead of establishing a structural, end-result-oriented approach. “Even if we had a structural program that the government would enforce, there would be uncontoured procedures in certain operations that wouldn`t fit the inspection programs. With a HACCP program, you can design these inspectional procedures so they`ll fit your operation to a “tee,” says Martinello.
The John T. Handy Co., Inc. (Crisfield, MD) supplies soft-shell crabs to restaurants and retail supermarket chains and distributors selling to seafood markets and gourmet restaurants like Legal Sea Foods. President Carol Haltaman, whose company has been under the Department of Commerce`s voluntary seafood program since 1984, says HACCP`s much more thorough and detailed approach has boosted company efficiency. She admits the program involves more “recordkeeping,” but views the added requirements as having a positive and not a negative, effect on the operation. “We feel we`re more efficient at what we do. We`re able to spot problem areas before we get an alarm.” She observes that people like to work in a clean, efficient facility. Good recordkeeping also helps in locating the few customer complaints they receive, enabling them to pinpoint procedures on a specific day.
The Handy Co. employs a full-time quality person who checks such things as weights and temperatures, coming in a half-hour before plant workers to inspect the plant for cleanliness. The company`s crabmeat is sent to an outside lab for testing. “Because we buy from several sources, we`re always testing the fish, pulling samples all the time,” Haltaman says. At the end of the day, workers clean their areas thoroughly with hot water and disinfectant. Every night the entire plant–walls, conveyor belts, and equipment–is hosed down with a high pressure sprayer containing hot water mixed with a sanitation solution and the floor flooded. Workers must dip their hands in a chlorine solution before donning gloves to handle the fish. Hairnets and beardnets are worn, and jewelry and nail polish are prohibited.
Once in place, a company`s HACCP program comes under FDA oversight. The FDA inspects the program and makes judgments, verifying and comparing it with the HACCP plan for the plant to see that it meets FDA food safety objectives. Acting Director Spiller says, “What we`ve attempted to draft is tailored to the seafood industry. It`s up to each individual processor to figure out what that`s going to look like in his or her operation–and really, no two HACCP systems need ever look exactly alike. There`s enough latitude within these principles to let people think through what their own system ought to look like–then to install, operate and own it. One of the reasons HACCP is in favor right now is that those who have done it consistently report that they derive benefits from it.” n