View Rule

Statement of Need: Ensuring the safety of seafood to consumers poses a unique challenge to both the industry that produces it and to regulators. Seafood involves more than 300 highly diverse species from around the world. It is the most perishable of all flesh foods. As stocks of traditionally consumed fish decline, the pressure to find new species increases. Most seafood is still wild caught, the range of possible human food safety hazards includes every hazard in the marine environment as well as those associated with aquaculture. It is essential that those who process seafood for consumers understand the hazards and the controls for those hazards. As a general rule, however, such knowledge is not a prerequisite for doing business. Preventive controls for ensuring safety are not always employed and good sanitation is not always practiced. Preventable illnesses from seafood do occur. Moreover, it is questionable whether the current regulatory system, which was developed for the general food supply, is best suited for the seafood industry. The current system provides the agency with a "snapshot" of conditions at a facility at the moment of the inspection. The reliability of the regulators' assumptions about conditions in the plant during the intervals between inspections creates legitimate concerns about the adequacy of the system. Moreover, the system places an undue burden on the regulator to find problems, rather than placing responsibility on the industry to demonstrate that it understands the human food safety hazards and is employing appropriate controls for those hazards. The HACCP system solves these problems. Processors design preventive controls that are tailored to their products and processes. In accordance with HACCP principles, these controls provide processors with immediate information about whether they are controlling hazards. The records generated by the monitoring of critical control points enable the plant and the regulator to observe key safety operations over time, rather than at a single moment.

Summary of the Legal Basis: FDA's application of HACCP is intended for the efficient enforcement of sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, which applies to products that contain substances that may render the product injurious to health and to processing conditions that are insanitary and that could render a product injurious to health.

Alternatives: Continuing the current system of highly generalized good manufacturing practices (GMPs) for seafood processors and intermittent inspections based on these GMPs would be less efficient and effective than a HACCP-based system for the reasons stated above. Continuous visual inspection is not a viable alternative. Few hazards associated with seafood are detectable through visual inspection. Moreover, the costs of such a system would likely exceed the nearly half-billion dollar public outlay now required to operate this kind of system for meat and poultry. ^PAnother alternative would be to direct significant additional resources toward greatly increasing the frequency of FDA's inspection of seafood, as well as increasing the agency's sampling, laboratory analysis, and related regulatory activities with respect to seafood. Even if the funds for increased inspection and sampling were available, this approach alone would not be the best way for the agency to spend its resources on protecting the public health because the current form of inspection is inherently less efficient and effective than a HACCP-based inspection. Increased reliance on end-product testing, moreover, would involve a certain amount of inefficiency that would require very large sample sizes to overcome.

Anticipated Costs and Benefits: Costs, first year, 69 million to 168 million, benefits first year 73-108 million, total discounted costs at 6 percent discounting: 677 million to 1,488 million. Total discounted benefits at 6 percent: 1,435 million to 2,561 million.

Risks: If this regulation is not adopted the U.S. industry will lose or be significantly hampered in exporting to the European Union market. In addition an opportunity to adopt an efficient and highly effective means of manufacturing and monitoring the safety of seafood will be lost. Finally, a major opportunity to significantly reduce the number of seafood related illnesses in the United States will also have been lost.