Exxon Valdez Oil Spill, San Francisco Rocks, Tylenol Tampering

by Food and Drug Administration (FDA)

(Page 3 of 3)

Exxon Valdez Oil Spill

After the oil tanker Exxon Valdez hit Bligh Reef in Alaska?s Prince William Sound March 24, 1989, spilling over 10 million gallons of oil into one of the state's richest fishing grounds, FDA dispatched investigators, scientists and advisors to the area.

The oil spill, which occurred just a few weeks before the beginning of Alaska's commercial fishing season, threatened to contaminate large quantities of the Sound's fish and shellfish.

FDA, the National Marine Fisheries Service, and Alaska departments of Environmental Conservation and Fish and Game worked to ensure that no oil-contaminated seafood found its way into human food supplies.

Agency investigators worked long hours inspecting seafood and fish tenders and their equipment and holds for oil contamination. (Fish tenders are large boats that collect the catches of smaller fishing boats and deliver the fish to processing plants on shore.)

Investigators, using sight, smell and touch, sampled about 200 fish from each tender as the catch was unloaded onto conveyer belts for processing.

Other investigators traveled from one fishing village to another throughout Alaska conducting one- and two-day inspections at one processing plant after another.

In 1989, 696 million pounds of salmon were caught, but only 50,000 pounds of oil-contaminated fish were found, primarily because of strict restrictions on commercial fishing areas. (See ?On the Trail of the Alaskan Oil Spill? in the April 1990 FDA Consumer.)

San Francisco Rocks

After earthquakes rocked northern California and San Francisco, Oct. 17, 1989, FDA was called in to help in a clean-up effort that included its own district offices.

For the week following the quake, while the General Services Administration inspected the district building, FDA employees worked out of makeshift offices in other government buildings and their homes.

Despite destruction to their own offices, FDA district employees, aided by Salinas and San Jose resident post staff, inspected nearly 400 pharmacies, plasma centers, grocery stores, and other industries.

Frozen food warehouses sustained the majority of losses in the San Francisco area due to power outages, while most medical device firms and pharmaceutical companies sustained little or no damage.

Much of the damage was in nearby Salinas Valley. One cannery lost $2 million to $3 million due to leaking and dented cans. In nearby Watsonville, almost 6 million pounds of frozen food from four processing plants was destroyed because it had either thawed or been contaminated by ammonia from leaky coolant pipes.

Humble Symbol

Swanson symbolizes his office's and FDA?s work with a well pump handle he has lying on his desk.

It's a symbol of a famous case where people were getting sick from a contaminated well. The public health measure was to take the handle off the pump so people couldn't pump the water out of the well.

FDA's goal is to make sure contaminated foods, drugs, cosmetics, and veterinary medicines or defective medical and radiation-emitting devices don't end up on store shelves.

But, if a contaminated or defective product makes it past the agency's safeguards, then, as Swanson says, "we try to take the handle off the pump."

Metaphorically taking the handle off the pump is an interim measure that protects the public until FDA gets at the source or cause of the problem and, when possible, takes steps to make sure it doesn?t happen again.

Tylenol Tampering

Another kind of disaster occurred in 1982 when someone tampered with Tylenol brand of acetaminophen capsules, an over-the-counter drug. The cyanide-tainted capsules killed seven people.

Two alert paramedics first informed FDA of the possible contamination.

Richard Swanson, FDA's emergency and epidemiological operations division chief, recalls: "The paramedics went to a house to pick up a victim. The victim's brother and wife then took some Tylenol capsules to calm themselves down because of the death of their husband and brother.

"Later, when the paramedics went back to the same house to get them as victims, the paramedics said 'Hey, something's wrong. This is the second time we've gone to this house.' That sparked it."

Once FDA learned of the Tylenol tampering, Chicago district investigators immediately removed the product from the market, visually inspected it, and found some contaminated product still on the shelves.

FDA also worked with Tylenol's manufacturer, McNeil Consumer Products Co., which initiated a nationwide voluntary recall.

Agency investigators inspected the two facilities that manufacture this product to determine if the tampering could have occurred there. When they determined this was not the case, the product was traced through the distribution chain — from manufacturer down to drugstores.

Swanson says, "FDA and McNeil prevented some further deaths by quick response in getting out there and getting that product off the market."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.