FDA Slammed Over Lax Enforcement

Despite tougher enforcement tools granted by the Food Safety Modernization Act (FSMA), FDA took no advisory or enforcement actions in response to 22 percent of the significant inspection violations it uncovered from 2011-2015, according to an audit by the Office of Inspector General (OIG) at the Department of Health and Human Services, FDA’s parent agency.

And when the FDA did take enforcement action, it was often slow in coming. Of particular concern, FDA most commonly asked facility owners to voluntarily correct serious violations, which didn’t always happen, instead of taking advantage of new powers granted by FSMA, including suspending a food facility’s registration, issuing a mandatory recall, or administratively detaining certain foods.

In one example, OIG said FDA inspectors found Listeria monocytogenes in a facility that also had rainwater visibly leaking through the roof directly above the food preparation area. The facility also had cracks and holes in walls and floors that prohibited adequate cleaning. Soon after the inspection, FDA issued a warning letter requesting prompt corrective actions. But the violations went uncorrected for two years, despite three additional inspections that documented ongoing unsanitary conditions and the continued presence of Listeria.

“This facility was not unique,” the report says. “If FDA does not take swift and effective action to ensure that all violations are corrected, it is unable to guarantee that the food handled by these facilities is safe and free from disease-causing organisms, chemicals, or other harmful substances.”

The September 2017 OIG report, “Challenges Remain in FDA’s Inspections of Domestic Food Facilities,” focuses on inspections conducted during FSMA’s first five years (2011-2015). FSMA requires FDA to inspect high-risk facilities at least once during an initial five-year inspection cycle and then at least once every three years afterward. Non-high-risk facilities must be inspected at least once during the initial seven-year cycle and then at least once every five years afterwards. Prior to FSMA there were no such set timeframes.

FDA reported inspecting all but nine of the 21,086 high-risk U.S. facilities as required by the end of 2015, and had also inspected about two-thirds of the 61,010 non-high-risk facilities by that time. With two years to go for the latter, the agency was on track to finish the rest of the non-high-risk facilities by the end of 2017.

OIG agreed to this assessment, but also noted that FDA counted a facility it attempted to inspect—but didn’t—as having been inspected. Most often, such a facility was out of business or otherwise not operating at the time of inspection. These non-inspections comprised more than 25 percent of all the facilities FDA counted as inspected.

FDA ‘Cop-Out’

“Attempted inspections occur when an investigator visits a facility but it is out of business or not in operation, but FDA counts those facilities in its inspection numbers related to meeting the mandates,” says David Acheson, MD, a former associate FDA commissioner for foods. “Reading between the lines, I don’t think OIG really approved of that strategy and saw it as a cop-out by FDA.”

After excluding these facilities, OIG says the total number of completed inspections actually decreased over time, from about 17,000 in 2004 to only 16,000 in 2015, despite an increase in the number of facilities coming under FDA jurisdiction. As a result, the proportion of facilities inspected by FDA has decreased substantially over time, from 29 percent in 2004 to just 19 percent in 2015.

Further, the proportion of non-high-risk facilities that FDA attempted to inspect, but didn’t, increased during the first cycle, from 6 percent of the total in 2011 to 68 percent of the total in 2015. Some of these facilities, such as seasonal facilities or those that were closed temporarily, still need to be inspected. But FDA doesn’t have an effective rescheduling policy in place, OIG says.

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.

In a brief notice published in the Federal Register in September, innocuously titled “Improving Customer Service,” USDA proposed moving the Codex Alimentarius (“Food Code”) program from FSIS into the Undersecretary for Trade and Foreign Agricultural Affairs. USDA’s Codex office helps formulate U.S. policy at the Codex Alimentarius Commission, part of the UN Food and Agriculture Organization and the World Health Organization. The 180-nation commission formulates international standards for food labeling, additives, pesticide residues, procedures for assessing food safety, as well as governmental import and export inspection and certification systems for foods.

The proposed USDA reorganization caught many off guard. “FDA strongly believes that moving Codex to the oversight of a trade promoting, non-science organization could undermine the credibility of U.S. Codex as a science-based enterprise,” wrote Stephen Ostroff, MD, deputy FDA commissioner for foods and veterinary medicine, in comments that FDA took the unusual step of making public.

Such a transfer “would build a perception that the United States places a stronger priority on advancing trade over public health,” Dr. Ostroff said. “This perception would be damaging to U.S. credibility, and FDA is highly concerned that this would compromise the effectiveness of U.S. delegates who participate in Codex, a majority of whom are from FDA.”

Mike Taylor, Dr. Ostroff’s predecessor under the Obama administration, urged Agriculture Secretary Sonny Perdue to “withdraw and reconsider” the proposed transfer.

“There has been no dialog on this proposal with the broad food safety community and no explanation from USDA of the problem the proposed reorganization solves,” Taylor wrote. “The credibility and effectiveness of Codex and its mission are too important to jeopardize through hasty action to fundamentally alter the program’s management.”

The outpouring of criticism caught the administration’s attention. In late October, Perdue notified Senate Agriculture Committee Chairman Pat Roberts (R-KS), that he was staying the planned Codex transfer pending “further discussion,” the senator’s communications director Sarah Little confirmed. But in a Nov. 14, 2017, agency memorandum, Perdue announced the transfer had occurred.

The U.S. now joins five other nations—Congo, Guinea, Lesotho, Madagascar, and Samoa—in having Codex oversight residing within their government’s trade promotion agency.