New Seafood Safety Rules Are Set; FDA Cites Illnesses

The Clinton Administration on Tuesday announced a vast expansion in the way the government inspects and monitors seafood, citing tens of thousands of cases of consumer poisonings every year by tainted fish and shellfish.

The new seafood regulations are the first of a series of such regulations likely to apply to a wide range of food products in coming years, including fresh meat and poultry.

Under the new system, the Food and Drug Administration would greatly enhance its enforcement procedures, which consist mainly of unannounced spot inspections of seafood processors, by requiring seafood businesses to identify points in the process at which contamination or other problems could arise.

The businesses would have to establish monitors to detect such problems and keep extensive records of their efforts. Those records then could be reviewed by federal inspectors to give them a more detailed picture of conditions that exist year-round.

“It’s like the difference between a series of infrequent snapshots and a constantly running videotape,” said one FDA official.

The existing system often leaves the FDA in the dark about problems until they erupt in a bout of illnesses. “Our safety inspections should focus on preventing problems rather than chasing the horses after they’re out of the barn,” FDA Commissioner David A. Kessler said in a prepared statement.

The FDA has estimated that anywhere from 20,000 to 60,000 Americans are sickened by contaminated seafood annually. Federal health officials do not know how many of those poisonings lead to death.

The Agriculture Department, which regulates fresh meat and poultry, is expected to release similar proposals next year, and the FDA is studying whether to impose the same type of controls on such segments of the food industry as dairy products, baked goods, breakfast cereals, salad dressings and other products.

The rules, first released in draft form in 1994, take effect immediately, although industry has two years to phase them in fully.

The current food safety regulatory system--first established in the early 1900s and regarded by virtually all quarters as outdated--is largely designed to respond only after problems occur.

The new regulations are modeled after a system originally created years ago by private food companies and the National Aeronautics and Space Administration to safeguard food prepared for astronauts.

The system, known as the Hazard Analysis Critical Control Point, is based on a scientific analysis of potential dangers and where they can occur in food processing. The idea is that once these critical control points are identified, steps can be taken at those stages in the process to ensure food safety.

For example, highly mechanized processing lines would be checked regularly to detect metal fragments in food, and records would be kept of those inspections. This not only would ensure that food is kept free of these contaminants but also would help companies that might later have problems determine how and when those problems occurred, the FDA said.

Also, if a seafood company were to purchase swordfish, it would be required to check the source of the harvest to be sure the fish had not been caught in waters known to contain methyl mercury, which has been a problem in the past.

While the rules do not apply to fishing vessels or transporters, processors must take responsibility for what they receive, the agency said.

If such information were unavailable or insufficient, companies would be required to sample and test for the chemical or to refuse the shipment.

The rules also contain special provisions to protect the safety of certain types of products.

Specifically, processors of raw molluscan shellfish--oysters, clams and mussels--must devise plans to ensure that they would accept shellfish only from approved waters.

The FDA now sets permissible levels of residue in shellfish, and states are responsible for enforcement. The new provisions would add another layer of safety by also making the processors responsible for the source of their shellfish.

In the case of smoked fish, controls would be established to protect against Clostridium botulinum toxin throughout the shelf life of the product.

The proposals have been supported by industry, which must have such systems to be able to export its products. The European Union soon will require firms that export seafood to its member countries to have hazard analysis systems in place.

Lee J. Weddig, executive vice president of the National Fisheries Institute, called the new system “the technology of the future for food inspection” and said that the seafood industry is “ready to be the first to use it on an industrywide basis.”

But Public Voice for Food and Health Policy, a consumer food issues group, said that the rules represent “a good first step” but that they create too much of an industry “honor system.”