OIG and GAO reviews find FDA must do better

By Joseph James Whitworth contact

- Last updated on GMT

Pic: ©Michael J. Ermarth/Flickr. Feb 2009; Los Angeles, CA – An FDA field inspector conducts on-site chemical analysis of imported produce
Pic: ©Michael J. Ermarth/Flickr. Feb 2009; Los Angeles, CA – An FDA field inspector conducts on-site chemical analysis of imported produce
The OIG and GAO have raised concerns about the US Food and Drug Administration (FDA) in two different areas.

The Office of Inspector General (OIG​) found inaccuracies in FDA's domestic food facility data meaning it attempts to inspect sites that are out of business or not in operation during the visit.

OIG is also currently reviewing FDA’s monitoring of domestic and imported recalls.

The Government Accountability Office (GAO​) said FDA and the US Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) could do more to prevent unsafe drug residues in seafood.

Decrease in FDA inspections

OIG looked at facilities that FDA designated high risk and non-high risk per FSMA, and whether they were inspected as required; facility inventory and inspection data from 2010-15.

The review found FDA is on track to meet domestic inspection timeframes for the initial cycles mandated by the Food Safety Modernization Act (FSMA).

FDA identified 21,086 high-risk facilities requiring an inspection within five years (2011-15) and 61,010 non-high-risk sites for inspection within seven years (2011-17).

By the end of 2015, it inspected - or attempted to inspect - all but nine of the high-risk plants.

With two years left in the initial seven-year cycle for non-high-risk facilities, FDA inspected - or attempted to inspect - about two-thirds (40,623) of them.

However, the number of sites FDA inspected has decreased from a high of about 19,000 in 2011 to just 16,000 in 2015.

Spending for domestic inspections

Spending for FDA domestic facility inspections increased by 80% from about $78m in 2004 to $140m in 2011, the first year of FSMA implementation. It decreased to $130m in 2015.

FDA officials said they are doing other things to protect public health such as responding to recalls, collecting samples, records and other evidence to identify the source of an outbreak.

oig fda facility inspection

OIG said FDA did not always take action when it uncovered significant inspection violations and commonly relied on facilities to voluntarily correct them.

FDA took no advisory or enforcement action in response to 22% of the significant inspection violations from 2011-15.

The review found FDA consistently failed to conduct timely follow-up inspections to ensure plants corrected significant violations.

For almost half of the significant violations from 2011-15, FDA did not do a follow-up inspection within one year and for 17% it did not conduct a follow-up inspection of the site at all.

For another 31% of these significant violations, FDA did not do a timely follow-up inspection.

A 2010 review found FDA inspected less than a quarter of domestic facilities each year and that many had not been inspected in five years or more.

Congresswoman Rosa DeLauro said the goal of FSMA was to prevent problems rather than react to them after they arise.

The FDA also counted facilities no longer in operation as being up to standard, thereby over estimating that number to make their results more favorable. [I] am outraged that the FDA only took enforcement measures against 5% of significant facility infractions, impacting food safety and consumers.”

Drug residues on imported seafood

GAO said most seafood eaten in the US is imported and about half is raised on fish farms.

FDA ensures the safety of most seafood and FSIS is responsible for imported catfish.

gao seafood drug residue

GAO recommended FDA look at agreements with other countries to test seafood exported to the country.

“By pursuing formal agreements with countries exporting seafood to the US that commit these countries to test for drugs of concern to FDA and the corresponding MRLs that the agency established for these drugs, FDA could strengthen its efforts toward ensuring that imported seafood does not contain unsafe drug residues,” ​said the agency.

It also advised FSIS to visit a sample of fish farms as part of foreign country on-site audits.

“It is not clear how FSIS could consider the conditions under which imported catfish are raised… without visiting foreign catfish farms. Without visiting at least, a sample of farms whose catfish are exported to the US, FSIS may be missing an opportunity to fully understand the conditions under which the catfish are being raised,” ​said GAO.

In 2015, China was the overall leading exporter of seafood to the US, India was top for shrimp and it was Vietnam for catfish.

HACCP regulations

FDA performs a limited number of inspections of processors and importers to ensure HACCP compliance and tests seafood for contaminants including unsafe drug residues.

In 2016, FDA inspected 144 foreign seafood processer facilities for HACCP compliance or nearly 2% of the 7,669 that exported seafood to the US that year.

Inspections do not include visiting the fish farms that supply the processor facilities to evaluate drug use or visiting labs asked by processors to test for unsafe drug residues.

From 2010-15, FDA refused entry for 1,726 seafood products for drug-related violations. The majority were of exports from China (37%), Malaysia (28%), Indonesia (12%) and Vietnam (11%). Shrimp represented 54% of all refusals and other seafood 32%.

Congresswoman DeLauro said the FDA’s failure to keep food safe was completely inexcusable.

“The remaining 98% of uninspected seafood processors represent an unacceptable, gaping hole in our food safety system. Worse than that, only 0.1% of the seafood imported from 2012 to 2015 was inspected for unsafe drug residue that is linked to cancer and allergic reactions,” ​she said.

“[The] FDA must hold nations that ship seafood to the US accountable to uphold our food safety testing standards. Allowing unsafe food to enter the US food supply should never be an option, and the FDA needs to take immediate action to fix this problem.”

According to FSIS re-inspection data, from May 2016 to July 2017, the agency tested 382 samples from 195 shipments of imported catfish.

FSIS found unsafe drug residues in 20 shipments and refused entry. These shipments included about 422,000 pounds of catfish and came primarily from processors in China or Vietnam.

The drugs included dyes used as anti-fungal agents and antibiotics not approved for use in catfish in the US.

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