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FDA Compliance

Regulators Caught in the Act of Protecting Public Health

FDA field inspectors take quality control with them

Published: Wednesday, December 24, 2014 - 00:00

 

We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live insects.

Their work, they knew, would prevent that shipment from reaching consumers, and they were justifiably proud.

“Government regulation” is a term often used with derision. During a recent tour to observe investigators in the FDA’s Office of Regulatory Affairs (ORA), however, the value of regulations was clear. So were the dedication, skill, experience, physical stamina, and pride investigators bring to one of the major steps in enforcing regulations. Those qualities appeared again and again—at a blood bank inspection in Boston, a juice facility in Philadelphia, an egg farm in Iowa, a smoked seafood plant in Seattle, and at the Miami warehouse.

About 91 percent of the seafood sold in the United States is imported; 80 percent of that comes through Miami. ORA inspector Michael McCoy offered us winter parkas for the inspection in the cold storage warehouse.

McCoy, a marine biologist, formerly specialized in aqua farming, who helped develop the process for farming shrimp, including the means to artificially inseminate them. He has worked for ORA for seven years. When he walked in the warehouse to sample yellowfin tuna from Surinam, someone announced, “It’s the meticulous one.”

From an even colder section of the warehouse, forklifts carried tuna-filled boxes called coffins, due to their size and shape. McCoy randomly selected 18 fish and from each one cut, from fin to belly, a sample. Then he weighed each piece before bagging and freezing it in dry ice for shipping to ORA labs in Atlanta. Inspection procedures call for one-pound samples. McCoy weighs each piece, but it turns out that in every case, he’s cut exactly one pound.

Just 24 hours after McCoy cuts the samples, the shipper learns the fish passed all tests and can be put on a plane to its buyer in Jericho, New York.

The cold warehouse inspection in Miami contrasts with the heat of an Iowa farm where 480,000 hens produce 144 million eggs yearly. FDA’s “Egg Rule,” or Title 21 of the Code of Federal Regulations, Part 118, is aimed at keeping the deadly bacteria Salmonella enteritidis from the egg supply.

We travel deep into the countryside and up a long gravel road. In a “safe area,” we put on disposable Tyvek suits, including booties, hairnets, gloves, and respirators. The suits are to ensure we don’t bring in anything to contaminate the area. At the door of the first of six henhouses, lead FDA investigator Katie Jo Close, a biologist, makes sure everyone walks through a box of powdered disinfectant—part of the farm’s biosecurity plan.

Sample collection requirements are exacting: For example, each swab for bacteria must be collected on a 4 in. × 4 in., 12-ply gauze square that has been moistened with evaporated milk poured from a can whose lid has been disinfected with 70 percent ethanol. The protocols for where samples must be collected and how they are handled are even more exacting.

Before coming to ORA nearly six years ago, Close worked for a seed company, researching ways to make higher-yield, drought-resistant corn. Currently, in addition to inspecting egg farms, Close inspects facilities producing juice, canned goods, and animal feed products, to name a few.

“I like the fact that each day is different,” Close says. “I feel like I’m protecting my family, my friends, my neighbors, everyone. I’m educating firms and farmers on how to follow the regulations that will prevent illness and death. I’m making a difference in people’s lives.”

From our desks in FDA headquarters, we see important work going on. Going into the field, though, is both humbling and inspiring. These men and women around the country, every day, are giving government regulations a good name.

First published Dec. 10, 2014, on FDAVoice.

 

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About The Authors

Melinda Plaisier’s picture

Melinda Plaisier

Melinda Plaisier is the associate commissioner for regulatory affairs at the Food and Drug Administration. She leads more than 4,300 employees and operations in the Office of Regulatory Affairs (ORA). Plaisier helps the FDA adapt to the continuing program-based and in implementing FDA’s expanded authority. Prior to FDA Plaisier worked for 13 years in the U.S. Congress for the Office of the Commissioner directing and managing the agency’s congressional relations and legislative activities. She also served as the associate commissioner for international programs where she focused on negotiating international agreements and working with developing nations.

Michael Landa’s picture

Michael Landa

Michael Landa is director of the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration (FDA). He leads the center’s development and implementation of programs and policies related to the composition, quality, safety, and labeling of foods, food and color additives, dietary supplements, and cosmetics. Landa has also served as deputy directory for regulatory affairs, chief and associate chief counsel for enforcement, medical devices, and veterinary medicine. Landa has a bachelor’s degree from Columbia College, a juris doctor degree from the University of Virginia, and a master of laws degree from New York University.