As a result, FDA could be challenged to meet future FSMA inspection mandates, which are to be shortened by two years. “Unless FDA increases its current pace of inspections of non-high-risk facilities, it will not be able to meet the mandates of future inspection cycles,” the report says.
FDA officials explained that they also had been engaged in other public health protection activities, such as responding to food recalls and collecting samples, records, and other evidence to identify the source of outbreaks.
5 Percent Enforcement
Of the 1,535 actions FDA took in response to significant inspection violations from 2011-2015, nearly three-fourths (73 percent) were advisory in nature, such as warning letters, untitled letters, or regulatory meetings, all seeking voluntary correction, despite having powers under FSMA, the report says. FDA undertook judicial actions, such as seizures or injunctions, in only 4 percent of the cases and initiated administrative actions, such as food detention, in only 1 percent of the cases.
FDA was also slow in actually taking action. Almost half of all warning letters were issued after the four-month response timeframe, and 20 percent were issued after more than six months; 2 percent were issued more than one year after the inspection. Even when the agency took strong actions, facilities could continue to operate under unsafe conditions. In one case, FDA took over a year for a seizure and almost two years for an injunction. And for almost half of all significant inspection violations, FDA did not conduct timely follow-up inspections within one year to ensure correction.
“I am alarmed that the OIG found a decrease in the number of facilities being inspected from 2011 to 2015,” said Rep. Rosa DeLauro (D-CT), a leading food safety advocate in Congress. “The FDA also counted facilities no longer in operation as being up to standard, thereby overestimating that number to make their results more favorable. Finally, I am outraged that the FDA only took enforcement measures against 5 percent of significant facility infractions, impacting food safety and consumers,” she said in a statement.
FDA spending on domestic facility inspections increased from $78 million in 2004 to $137 million in 2010, and then to $140 million in 2011, the first year of FSMA. Afterward, however, spending dropped to $130 million in 2015.
The Trump administration’s Fiscal 2018 budget request, submitted to Congress in May 2017, would slash FDA’s budget by more than $870 million, or nearly one-third, from about $2.76 billion to $1.89 billion. Food safety activities would be cut by $83 million largely by not filling vacant staff and inspector positions and cutting back on food safety research activities. However, as of this writing, Congress and the White House appear to be in agreement in maintaining federal agency funding at 2017 levels, at least through the end of the year.
“It is clear that the FDA needs more resources to efficiently and effectively inspect food facilities and enforce infractions to keep our food supply safe,” Rep. DeLauro said.
OIG makes four recommendations: 1) identify facilities that do not need to be inspected because they are out of business and remove them from the list, 2) take the most effective actions to achieve compliance, using FSMA tools more frequently, 3) initiate regulatory actions promptly, and 4) conduct timely follow-up inspections.
FDA concurred with all four recommendations, noting that it already was developing systems to better track agency and company activities associated with each violation. Dr. Acheson urges companies to take this as a warning. “We can expect FDA to come down very hard on facilities that have violations and to follow up aggressively,” he says. “Likely some companies will be made an example to get everyone in line. Maybe we will see more suspensions of registration. I would not be surprised.”
USDA Under the Gun
The Trump administration may be excused for FDA’s poor performance because it occurred during the Obama administration. But such is not the case when it comes to USDA, which recently proposed shifting responsibility for international food safety issues from the science-based Food Safety and Inspection Service (FSIS) to its promotion-oriented Trade and Foreign Agricultural Affairs office.