Watchdog audits fire warning shots at the FDA’s food safety program

In recent years, the Food and Drug Administration (FDA) has been given the authority to expand food safety inspections. But the agency’s food safety program recently come under close scrutiny by federal watchdogs for failing to protect public health with these much-needed additional inspections mandated by federal law.

The Office of the Inspector General (OIG) at the Department of Health and Human Services and the Government Accountability Office (GAO) have published three highly critical audits revealing shortcomings in the FDA’s enforcement of food safety policies – even though the Food Safety Modernization Act (FSMA) was enacted in 2011 to give the agency new food safety enforcement authorities, and the agency has received substantial increases in its appropriations to implement the new law. Yet, we continue to see the same problems that predated the legislation.

In September 2017, the OIG issued a report that found that while the FDA was on track to meet the inspection mandates of the FSMA for domestic food establishments (every three years for high risk and every five years for low risk plants), the number of inspections actually declined between 2011 and 2015 – from 19,000 to 16,000. In addition, the OIG found that the agency did not always follow up when its inspectors found significant food safety violations to verify that the issues had been addressed. In nearly one in five instances, the agency never followed up, and when it did, it often took over a year.The FSMA calls for an “integrated food safety system” that uses the resources of state food inspection agencies to supplement the work of the FDA inspectors. In a recent meeting with state food and drug inspection officials, we learned that the agency has not made room for enough state inspection personnel to get trained on the new regulations. Those state officials informed the FDA that their agencies will refuse to conduct required inspections unless their personnel are properly trained by the agency. This stance is justified because in 2000 and in 2011, the OIG found that the FDA provided poor oversight of inspections it had contracted for the states to conduct.

Soon after the OIG report on domestic inspections was released, the GAO published a report in October 2017 on the safety of imported seafood. Seafood safety has been the topic of at least a dozen GAO reports since the 1980s. Over 90 percent of the seafood consumed in the U.S. is now imported, yet the FDA is only able to conduct in-depth inspections of about 2 percent of the imported lines of entry. In 1998, the agency implemented the seafood Hazard Analysis Critical Control Point (HACCP) rule to “modernize” seafood safety. To this day – some two decades later – FDA inspectors still find that some seafood processors, both domestic and foreign, have yet to write effective food safety plans. Aquacultured seafood has become especially problematic since some foreign countries permit the use of fungicides, antibiotics, and other chemicals that are banned in the U.S. because of their human health effects. After years of frustration with the lack of enforcement of food safety standards for imported catfish products, the Catfish Farmers of America successfully lobbied Congress in 2008 to shift the inspection of these products from the FDA to the USDA, even though it meant that their domestic products would be also subject to stricter food safety standards and continuous USDA inspection.

On Dec. 22, 2017 the OIG released a report that revealed major deficiencies in the FDA’s food recall process, even issuing a rare “early alert” in 2016. The agency has traditionally not written its own press releases on food recalls and merely republishes company press releases, sometimes days after a recall was initiated. It is only when the FDA finally sends out the company’s press release that there is widespread media coverage to create any urgency to get the products out of commerce. And the company press releases often contain boilerplate language extolling the virtues of the company instead of focusing on the public health consequences of the recall. To make matters worse, not all food recalls have been publicized by the FDA. Often, food recalls have been buried in the agency’s enforcement reports. When questioned about this, the agency’s response was that there were too many recalls to publicize.

The FDA has also lagged behind other agencies in updating its recall process. In 2004, the USDA began to include photos on its press releases to help consumers identify recalled food products under its jurisdiction. But the FDA did not do so until 2011. When we asked FDA officials in 2004 why it did not follow the USDA’s lead, they claimed that it was too difficult. Lastly, as Thomas Gremillion from the Consumer Federation of America recently argued, the FDA should start publishing the names of the retailers that sell recalled food products, which the USDA has been doing for over a decade. Ironically, in May 2017, Pinnacle Foods announced a recall of Aunt Jemima frozen pancakes, frozen waffles and frozen French toast for listeria monocytogenes contamination. The FDA did not list the retailers who sold these products, but the USDA did when the recalled items contained meat products. If the USDA can provide this information, so should the FDA.

The FDA must start putting people and public health first in its policies and not bend over backwards to protect corporate interests. The agency should also allocate its resources to support its field staff because that is where the rubber meets the road in enforcing food safety regulations. Food & Water Watch worked to shape the FSMA when it was being written and we have been supportive of increasing the appropriations to the agency for food safety. But as both the OIG and GAO have repeatedly pointed out, there are warning signs that the FDA is not moving fast enough to modernize its food safety program. As the FSMA begins to be fully implemented, the agency still has a long way to go to achieve the “preventative food safety system” that the legislation was supposed to deliver.