firecat

Posted by ARRAY(0x555981c57d28)

https://www.propublica.org/article/foreign-food-safety-inspections-historic-low-fda

American inspections of foreign food facilities — which produce everything from crawfish to cookies for the U.S. market — have plummeted to historic lows this year, a ProPublica analysis of federal data shows, even as inspections reveal alarming conditions at some manufacturers. 

About two dozen current and former Food and Drug Administration officials blame the pullback on deep staffing cuts under the Trump administration. The stark reduction marks a dramatic shift in oversight at a time when the United States has never been more dependent on foreign food, which accounts for the vast majority of the nation’s seafood and more than half its fresh fruit.

The stakes are high: Foreign products have been increasingly linked to outbreaks of foodborne illness. In recent years, FDA investigators have uncovered disturbing lapses in facilities producing food bound for American supermarkets. In Indonesia, cookie factory workers hauled dough in soiled buckets. In China, seafood processors slid crawfish along cracked, stained conveyor belts. Investigators have reported crawling insects, dripping pipes and fake testing data purporting to show food products were pathogen free.

In 2011, Congress — concerned about the different standards of overseas food operations — gave the FDA new authority to hold foreign food producers to the same safety standards as domestic ones. Although the agency’s small team remained unable to visit every overseas facility, inspections rose sharply after the mandate — sometimes doubling or tripling previous rates.

Now, the U.S. is on track to have the fewest inspections on record since 2011, except during the global pandemic.

Foreign Food Inspections at Lowest Point in Over a Decade, Excluding Pandemic Years

Fewer inspections have taken place than at any time since 2011, excluding 2020 to 2022, when inspections slowed significantly because of the coronavirus pandemic.

Inspections began to decline early in the administration, after 65% of the staff in the FDA divisions responsible for coordinating travel and budgets left or were fired in the name of government efficiency. 

Investigators suddenly had to book their own flights and hotels, obtain diplomatic passports and visas, and coordinate with foreign authorities, former and current FDA staffers told ProPublica. After workers tasked with processing expenses were laid off, investigators waited as a backlog of unfulfilled reimbursements climbed to more than $1 million, a former staffer said. (Investigators are responsible for paying off their own credit cards.) Senior investigators close to retirement also took the opportunity to get out. 

Played out on a large scale, this combination of firings and voluntary departures has left the agency scrambling to make up for the loss of 1 out of every 5 of its workers responsible for ensuring the safety of America’s food and drugs. 

Susan Mayne, the former director of the FDA’s Center for Food Safety and Applied Nutrition and an adjunct professor at Yale School of Public Health, expressed alarm at the drop in foreign inspections. 

“It’s very concerning that we are seeing these kinds of reductions,” said Mayne, who emphasized the administration’s cuts have hamstrung an agency that has long struggled to retain investigators who conduct both foreign and domestic inspections. In an attempt to maintain its numbers, the agency had been working on initiatives to elevate pay and adopt specialized training for investigators. “The plans that were in place to address staffing have now been undermined.”

The gutting of the workforce coincides with other actions the administration has taken that are poking holes in the nation’s food safety net. In March, the FDA announced it was delaying compliance with a rule to speed up the identification and removal of harmful products in the food system, to give more time for companies to follow the rules. The next month, it suspended a quality control program that ensured consistency and accuracy across its 170 pathogen and contaminant labs as a result of staffing cuts.

Then in July, the administration quietly scaled back the Foodborne Diseases Active Surveillance Network, also known as FoodNet, shrinking its surveillance to just two pathogens: salmonella and a common type of E. coli. The program — a partnership between the FDA, the Centers for Disease Control and Prevention, the Department of Agriculture and state health departments — was responsible for the critical monitoring of eight foodborne illnesses, including infections caused by the deadly bacteria listeria. In response to the change, a CDC spokesperson previously claimed that the program’s surveillance had been duplicative.

The administration did not respond to ProPublica’s questions about these actions.

“There are going to be things that fall through the cracks, and these things aren’t negligible,” said a current FDA investigations official who spoke on the condition of anonymity, fearing reprisal. The same was true of other current and former agency staffers; those who still had jobs risked losing them, while former employees worried about their chances of being rehired or the security of their severance or retirement packages.

The Department of Health and Human Services refused to respond to any of ProPublica’s questions about the decrease in foreign food inspections, citing the government shutdown. “Responding to ProPublica is not considered a mission-critical activity,” said Emily Hilliard, the department’s press secretary. The FDA and the White House also did not respond to requests for comment.

“Basic regulatory oversight functions have been decimated,” said Brian Ronholm, the director of food policy at Consumer Reports. “There’s an enhanced risk of more outbreaks.”

An Agency Already Struggling

The FDA has long been one of the main protectors of the American food supply. The federal agency oversees about 80% of what people eat, including fruits, vegetables, processed goods, dairy products and infant formula and most seafood and eggs. It regulates more than 220,000 farms, food plants and distributors, inspecting facilities, testing for pathogens, tracing outbreaks and issuing recalls.

Only 40% of the facilities that the FDA regulates are within the nation’s borders. While the agency examines some products at ports of entry, those reviews are often cursory; workers cannot manually inspect every import or uncover whether a foreign plant properly cleans its equipment, conducts adequate salmonella testing or has a rat infestation. In-person facility inspections are necessary for that kind of insight.

For example, in 2023, an FDA investigator inspected a Chinese manufacturer of soy protein powder, a common additive in shakes and other beverages. While the company had previously imported its products into the United States without scrutiny, the investigator’s thorough visit found numerous violations, according to an agency report obtained through a federal records request.

Live insects crawled through the facility’s production workshop, while dead ones lay on the floor. Condensation from rust-covered pipes dripped into a water tank waiting to be mixed with raw ingredients. Just outside the plant, the investigator found processing waste and stagnant water coated with a green biofilm, attracting a swarm of bugs too numerous to count.

When the investigator reviewed the firm’s bacteria testing records, which purportedly verified the products were free of salmonella and E. coli, he discovered the company was providing fake data to “satisfy the customer specifications,” according to his inspection report. 

Company officials also tried to obstruct his inspection, blocking him from entering a packaging room when he tried to photograph the pest infestation. After the three-day review, the federal agent censured the company, Pingdingshan Tianjing Plant Albumen Co. Ltd., which promised to take corrective actions. The company did not respond to ProPublica’s emailed questions.

If investigators find a foreign food facility is unable to comply with American safety requirements or refuses to permit the FDA to inspect its establishment, the agency can block its products from entering the country.

These crucial foreign inspections are neither easy nor cheap. They typically last longer than domestic ones and cost nearly $40,000 a visit, and they can require months of logistical planning, special visas and diplomatic approval from the host country.

In part because of these challenges, there was a time when the FDA conducted only a few hundred foreign inspections annually.

Then Congress passed the Food Safety Modernization Act of 2011, which set firm targets for the agency: It needed to conduct more than 19,000 foreign food inspections annually by 2016 and increase the number of food field staff to no fewer than 5,000 workers. 

The FDA has never fulfilled this congressional mandate. Even before the second Trump administration, the agency was inspecting less than 10% of its target each year.

Dr. Stephen Ostroff, a former acting commissioner of the FDA who also served as the deputy commissioner for foods and veterinary medicine, said that the agency’s foreign food inspections have long been hindered by a lack of resources.

“It’s not because the agency isn’t interested in doing more overseas inspections — they are,” said Ostroff, who retired from the agency in 2019. “They simply don’t have the resources to be able to meaningfully do large numbers of overseas inspections.”

One major obstacle has been a lack of financial support. “Congressional appropriators have never provided the funding that FDA has determined it would need to do those foreign inspections,” said Mayne, who retired from the agency in 2023. Before the food safety act passed, the Congressional Budget Office estimated that the agency would need about $1.4 billion over five years to comply with the new requirements, which included the expansion of field staff and foreign inspections. But lawmakers approved only a fraction of that amount.

As of last year, the agency had about 430 employees conducting both foreign and domestic food inspections, with only 20 investigators dedicated solely to international assignments. 

With such limitations, the agency’s inspections have often been reactive instead of proactive. In 2023, for example, FDA investigators did not descend on a Mexican strawberry farm until about 20 people had been hospitalized with hepatitis A, a highly contagious infection that causes liver inflammation and, in some cases, liver failure and death.

Hepatitis A is spread through the consumption of small or even microscopic bits of feces. Farm workers can shed the virus when picking fruit, or it can be transmitted through contaminated water. 

At the Mexican berry farm, federal investigators found significant safety violations, including sanitation facilities with hand-washing water that was dirty, gray and leaking throughout the growing area; one toilet offered no ability to wash one’s hands. The FDA censured the company, citing 11 violations of American food safety regulations. According to public data, the agency did not reinspect the farm to ensure it had made corrections even as its products kept entering the United States.

In January, less than two weeks before the second Trump administration came in, a report by the Government Accountability Office rebuked the FDA for consistently falling short of its foreign food inspection targets. The oversight office, recognizing the vital importance of the FDA’s food safety mission, urged Congress to direct the agency to assess how many foreign inspections are needed to keep the country’s food supply safe. 

The FDA said in response that, in 2025, it would increase staffing levels and prioritize the training and development of investigators. 

Then Donald Trump was inaugurated. 

Reversing a Decade of Gains

During the first few weeks of the new Trump administration, foreign inspections carried on as usual. But the sudden hemorrhaging of FDA workers through firings, retirements and buyouts quickly foiled the agency’s plans to ramp up staff and inspections.

While the administration had vowed that food safety inspectors would be spared, it began to cut critical investigative support staff in March, a move that would eventually incapacitate foreign inspections, current and former FDA staffers told ProPublica. 

As the agency lost support staff, their responsibilities shifted to investigators, who were quickly overwhelmed by the new burdens. Passports, visas and travel were all delayed.

“Support staff are not just there to bide time — they have a meaningful role,” said Sandra Eskin, who served as a top USDA food safety official in the Biden administration and is now the CEO of advocacy group Stop Foodborne Illness. “It’s like a game of Jenga: If you pull out one from the middle or the bottom, the whole tower collapses.”

In recent years, the agency has typically been able to conduct about 110 foreign food inspections each month, but in March, the number of inspections dropped almost in half compared with the monthly average in the previous two years.

As specialists who handled reimbursements were also fired, some investigators waited months for repayment, which made them reluctant to take on other foreign assignments, former and current staffers said. 

The cuts and growing work burden quickly collapsed morale across the investigative division, leading many senior investigative officials with decades of experience to retire.

“We already had a significant percentage of our workforce that was eligible for retirement,” said a current FDA employee in the investigations division, “so reading the writing on the wall, they decided to exit.” These departures also interrupted the development of new investigators, as some of the senior staff members who left had been tasked with training new hires, a process that can take up to two years. 

“There’s been such a brain drain,” said food safety expert Jennifer McEntire, founder of consulting firm Food Safety Strategy, “when inspectors do go out and are observing things, there’s no phone-a-friend.”

Instead of addressing the shortfall, in May, FDA Commissioner Dr. Marty Makary announced that the agency would expand the number of unannounced foreign inspections, in which investigators show up at facilities without alerting them first. Given the limited staff and resources, several current and former staffers told ProPublica that the prospect of conducting unannounced visits was impractical and even “comical.”

Read More

How Deeply Trump Has Cut Federal Health Agencies

“A foreign unannounced trip is like an accelerated coordination process,” said a current FDA investigations official. “If you’re going to increase the number and not increase the staff, we don’t know how to make some of that stuff work.”

By the end of July, the number of foreign food inspections conducted by the agency was nearly 30% lower compared with similar periods in the previous two years. The administration refused to provide ProPublica with up-to-date inspection numbers, so we relied on data from the FDA’s public inspection dashboard to conduct this analysis.  

Foreign inspections are not the only tool for overseeing food from abroad. The agency has developed partnerships with counterparts in other countries to ensure comparable oversight and required importers to verify that their foreign suppliers are following American standards. However, former and current agency staffers said that these initiatives also have been impacted by the administration’s cuts and recent departures.

While the administration’s cuts were ostensibly ordered to maximize efficiency and productivity, they have had an opposite effect, several former and current FDA employees said, reversing years of progress.

“The goal is to accomplish as much and more with less resources,” said a former high-level FDA investigations official. “Less inspections translate to less regulatory oversight, and that, from a public health perspective, never benefits the public.”

Scott Faber, senior vice president for government affairs at the nonprofit advocacy organization Environmental Working Group, said the fallout is simple: 

“When you take a wrecking ball to the federal government, you are going to wind up undermining important government functions that keep all of us safe, especially our food,” he said. “It’s only a matter of time before people die.”

How We Calculated Foreign Food Inspections

To understand how inspections of foreign food facilities have changed, we used a publicly available dashboard where the FDA publishes the results of those inspections. This database also includes inspections for manufacturers of drugs, medical devices, cosmetics, tobacco, biologics and veterinary products.

Beginning in May, we downloaded the entire database weekly and tracked the number of newly added foreign food facility inspections. 

The dashboard is continually updated, with data added after inspections are finalized. That typically occurs 45 to 90 days after the close of an inspection, though some reports may not be posted until the agency takes a final enforcement action. Through an analysis, we determined that few reports are added more than 90 days after an inspection date.

Our story therefore only includes inspections through July. In an accompanying chart, we show the more provisional data through September. We asked HHS for recent figures, but the department refused to share them. 

We considered the possibility that the downtrend in foreign food inspections was solely due to a lag in inspections being added to the dashboard. To check this, we performed the same analysis on domestic inspections. This analysis showed that while the rate of foreign inspections had significantly decreased, domestic inspections have continued almost uninterrupted.

The post Foreign Food Safety Inspections Hit Historic Low After Trump Cuts appeared first on ProPublica.

https://www.propublica.org/article/foreign-food-safety-inspections-historic-low-fda