- The U.S. Food and Drug Administration needs to ramp up inspections of domestic food facilities and followup responses if the agency is to make the tighter timelines required under the Food Safety Modernization Act, according to a recent report from the Inspector General of the U.S. Department of Health and Human Services.
- The overall number of facilities FDA inspected in the four years since FSMA passed declined from about 19,000 in 2011 to 16,000 in 2015. FDA did not always take action when it uncovered significant inspection violations, and it often relied on facilities to voluntarily make corrections. Follow-up inspections were also inconsistent. For almost half of the significant violations, FDA did not follow up within a year. For 17%, there was no follow-up inspection at all.
- The report analyzed data from four sources: Information about facilities with different risk designations and whether these facilities were inspected as required; FDA’s food facility inventory and inspection data from 2010 to 2015; information about FDA’s advisory and enforcement actions — such as warning letters and seizures — as well as whether follow-up inspections were conducted; and interviews with FDA officials.
With FSMA's passage in 2011, FDA's responsibilities increased, but funding hasn't kept pace. The report shows that spending on domestic food facility inspections actually declined between 2011 and 2015, although it initially went up by 80% from 2004 to the first year of FSMA implementation in 2011. That year's initial inspection spending spike went to $139.7 million, but then the amount dropped in 2012 and 2013, bumped up slightly in 2014, and fell again to $129.8 million in 2015.
The report also found that although the number of food facilities inspected has declined since 2011, the total number of them under FDA jurisdiction has increased.
"As a result, the proportion of food facilities inspected by FDA in a given year has decreased substantially over time — from 29 percent in 2004 to just 19 percent in 2015. Notably, the proportion of facilities inspected has decreased each year since the enactment of FSMA, with an overall drop by about a quarter from 2011 to 2015," the report stated.
FDA officials gave several reasons they were unable to inspect more facilities — even when resources increased, according to the report. They were engaged in other activities to protect public health, such as responding to food recalls, as well as collecting samples, records, and other evidence to identify sources of outbreaks. And they said they needed to expend resources to attempt to inspect facilities — sometimes just to confirm that they were out of business — to meet the FSMA mandates.
Even when FDA inspections took place, the agency took no advisory or enforcement action in response to 22% of the significant inspection violations from 2011 to 2015, the report found. If the agency takes no action in such cases, facilities may not correct the violations, and this undermines FDA’s efforts to ensure that the food supply is safe, the report concluded.
The report made four specific recommendations to FDA: Improving how attempted inspections are handled to ensure better use of resources; taking appropriate action against facilities with significant violations; improve the timeliness of its actions so that facilities stop operating under harmful conditions, and conducting timely follow-up inspections to ensure violations are corrected. The report noted that FDA concurred with everything.
It's hard to see how FDA will be able to meet the tightened inspections timelines under FSMA without significant increases in staff and funding. The Trump administration proposed a fiscal 2018 FDA budget of $1.89 billion in direct government funding, which is $854 million less than current levels — a 31% cut.
It will be a tough sell if the agency tries to justify a higher domestic food facility inspection budget when — as the report indicates — it has done less and less in the past few years with what it already has.