Update: How Will the Government Shutdown Affect the FDA?
By Beth Mole for Ars Technica
Update: Last week, FDA Commissioner Scott Gottlieb, M.D., said that some routine food safety inspections were suspended during the government shutdown, but that he was working on finding a way to resume inspections on high-risk facilities. Yesterday, Dr. Gottlieb announced on Twitter that some inspections would be able to resume.
For instance, inspection teams will return to facilities that are considered "high risk"—such as those producing soft cheeses, custard-filled bakery products, some produce, seafood, and baby formula—as early as today, the New York Times reports. And Dr. Gottlieb said more inspections will continue to resume throughout the week.
"[We're] re-starting high risk food inspections as early as tomorrow. We'll also do compounding inspections this week. And we started sampling high risk imported produce in the northeast region today. We'll expand our footprint as the week progresses. Our teams are working," Dr. Gottlieb wrote.
In total, about 400 people are returning to their jobs as part of this effort, the majority of which are inspectors or staff who support inspectors: "This includes about 100 staff focused on inspections of high risk medical device manufacturing facilities; about 70 staff focused on inspections of high risk drug manufacturing facilities; and about 90 staff focused on inspections of high risk biological manufacturing facilities," Dr. Gottlieb said. Another 150 or so employees "are focused on other aspects of our mission," he said.
Unfortunately, the inspection teams will be doing this work unpaid until the shutdown ends, he continued. "These men and women are the tip of the spear in our consumer protection mission. They're the very front line. And they're on the job. The entire nation owes them gratitude. I'm inspired by their dedication," he said.
Original report (January 10, 2019):
After a year plagued by deadly E. coli outbreaks linked to widely distributed romaine lettuce, 2019 is off to an anxiety-inducing start. With hundreds of food inspectors furloughed in the ongoing government shutdown, the FDA has suspended all routine inspections of domestic food processing facilities, according to Commissioner Scott Gottlieb, M.D., who revealed the news in an interview with the Washington Post published Wednesday.
Dr. Gottlieb said that the agency, which oversees about 80 percent of the food supply, is continuing to surveil foreign manufacturers and imported food, as well as any domestic producers involved in a current recall or outbreak.
But the agency is skipping the 160-or-so routine food inspections it usually performs each week. In those evaluations, FDA inspectors assess manufacturing practices at food-processing facilities, as well as check for unsanitary conditions, such as infestations, and contamination issues. About a third of those 160 weekly inspections involve facilities that the agency considers “high risk,” Dr. Gottlieb added. High-risk facilities are those that either handle foods particularly vulnerable to safety issues, such as soft cheeses and seafood, or facilities that have a track record of food safety problems.
“We are doing what we can to mitigate any risk to consumers through the shutdown,” Dr. Gottlieb told the paper.
He’s now working on a plan to call back 150 inspectors to focus on the high-risk facilities. While those workers still wouldn’t be paid until after the shutdown ends, Dr. Gottlieb said he was setting up an agency travel account to help those inspectors keep large balances off their personal credit cards.
Still, Sarah Sorscher, deputy director of regulatory affairs at nonprofit advocacy group The Center for Science in the Public Interest, called the missed inspections unacceptable in the Washington Post. “That puts our food supply at risk,” Sorscher said. “Regular inspections, which help stop foodborne illness before people get sick, are vital.”
Each year, an estimated 48 million people are sickened by foodborne illnesses in the U.S., leading to 128,000 hospitalizations and 3,000 deaths, according to the CDC.
The good news is that meat, poultry, and egg facilities not inspected by the FDA are overseen by the U.S. Department of Agriculture, which has maintained inspections during the government shutdown.
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