WASHINGTON — As the country enters day 21 of the federal government shutdown, consumer representatives worry that food products routinely inspected by the FDA or the Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) are making their way to Americans’ kitchen tables.
USDA is among the federal departments that has lost funding. Although most of the Department of Health and Human Services (HHS) is not affected, the FDA is funded separately and is part of the shutdown.
“The inspection activity, the regulatory activity that helps to prevent people getting sick, has been suspended or dramatically diminished,” Gremillion told MedPage Today.
“So, if there’s a peanut paste plant that’s infested with rodents and is creating foodborne illness risks for consumers, the FDA is not going to be coming out to that plant while the shutdown is going on,” he said.
While the USDA inspects meat, poultry, and egg products — dried, liquid, or frozen eggs — shell eggs fall under the FDA’s jurisdiction. These are categorized by the agency as “high risk,” and as such are continuing to be inspected, according to FDA Commissioner Scott Gottlieb’s updates on Twitter.
The majority of food inspectors for USDA will continue to work, but without pay.
According to the USDA’s FY 2019 contingency plan, about 89% of FSIS staff — a total of 8,434, out of 9,461 employees — are on the job.
The USDA inspects meat and poultry, in addition to egg products.
Grain and “other commodity inspections” will also carry on, as they are user-fee funded. Import and export inspections continue as well “to prevent the introduction and dissemination of pests into and out of the U.S.,” according to an agency press release.
Gottlieb said via Twitter on Wednesday that he’s working to expand food safety surveillance inspection to ensure that inspections for all high-risk foods, which make up about a one-third of the roughly 160 domestic inspections that occur each week, continue, and he stressed that the agency is continuing “ALL of our regular foreign food inspections.”
Other high-risk products besides shell eggs include seafood, dairy products, soft and semi-soft cheeses, unpasteurized juices, fresh fruits and vegetables as well as processed ones, spices, sandwiches, prepared salads, and infant formula.
He also noted that “medical foods” (those whose labels indicate use in managing diseases), “modified atmosphere packaged products,” and “acidified and low acid canned food” are also high-risk products.
An FDA spokesperson told MedPage Today that the agency is working to bring some furloughed inspectors back to work to perform inspections of high-risk products.
The spokesperson noted that the agency acknowledges that employees incur travel costs as they perform their duties without pay and that the FDA is “working out ways to try to buffer that hardship.”
Steven Grossman, JD, deputy executive director of the Alliance for a Stronger FDA, told MedPage Today what interrupting routine inspections means for consumers. “Farmer Jones gets inspected every second or third year,” he said. “It’s essential, but if it occurs in March instead of January … it’s hard to argue that it’s so immediate that it can’t wait till March,” he said.
About 41% of the FDA’s staff — 7,053 of the agency’s approximately 17,397 employees — were furloughed during the shutdown, according to an HHS 2019 contingency plan.
Grossman added, “I think they’re doing a great job with the staff and the responsibilities that they’re allowed to undertake, but inherently if FDA isn’t running at full tilt … it’s a riskier environment than it needs to be.”
As of early Friday, according to the FDA’s website, five food-related warnings have been issued since the shutdown began. These included recalls, market withdrawals, and safety alerts, related to certain brand of wavy potato chips, organic sunflower butter, 2% vanilla milk, ham and cheese sandwiches, and pre-made salads.
The FDA oversees regulation for about 20% of all consumer spending, including food, drugs, dietary supplements, radio-emitting devices, and medical devices, Grossman said, and most of the work employees do is “essential.”
However, in the case of this shutdown, “the standard that’s being applied is not essential, it’s immediacy,” said Grossman.
“If the absence of you or your job activities creates an immediate threat, you’re asked to come in and work,” he explained.
Grossman used air traffic controllers as a comparison. “Of course, they’re essential, but the reason they’re all working is because their absence would pose an immediate threat to public health and safety,” he said.
Gremillion offered an example of a program that may not have an immediate impact, yet its suspension could end up hurting people.
The USDA was engaged in a “rush effort” to develop a new Campylobacter test to replace current versions deemed inadequate, but those efforts appear to have been suspended, Gremillion said.
The Alliance recently released an “FDA shutdown toolkit” detailing which activities are continuing because of immediate need, those that are continuing due to the availability of carryover funds, and activities that are currently being paused.
The group noted that “food programs are thinly staffed, apart from import inspectors, individuals working on recalls, and other front-line employees needed to address essential duties that protect human and animal health and safety.”
At both the USDA and the FDA, Gremillion said he worried about the impact of workers not being paid.
“If I wasn’t getting paid for weeks on end, I might justify to myself cutting some corners at some point…. Are you even going to show up?”
But an FDA spokesperson rejected this notion. “This is a very dedicated group of public servants…. We take the safety of the American people very seriously.”
Asked about the absenteeism rate, the spokesperson said those numbers are not currently available.
USDA did not respond to a request for comment for this story.
With regard to drug and device review, Gottlieb explained on Twitter that the agency is continuing to work on existing medical product applications (submitted before Dec. 22) using carryover funding, but that it cannot accept new user fees or new applications.
Gottlieb said the agency has “about one month of funding left.”
And in his letter to employees dated Dec. 22, Gottlieb stressed that “[m]ission critical surveillance for significant safety concerns with medical devices and other medical products” would continue during the shutdown.
And on Tuesday, Gottlieb tweeted that the agency is re-prioritizing its resources. Specifically, he noted that user fee money would be re-allocated from “certain pre-market drug work to post-market safety surveillance.”
“Our consumer protection role is our most critical mission,” he said.