OIG Report: FDA Inspection of Food Plants and Enforcement Have Tumbled

Food safety legislation languishes in the Senate...
This week is National Public Health Week, and a new report from the Office of the Inspector General is "celebrating" with some bad news for those who are interested in food safety.  A report issued Tuesday, "FDA Inspections of Domestic Facilities," finds that FDA is currently getting an F for food safety. Between fiscal 2004 and 2008, the Food and Drug Administration inspected fewer than half of the 51,229 facilities that it regulates. And during the same time period, the number of regulatory actions prompted by inspections declined by more than fifty percent, from 614 in 2004 to 283 in 2008, the report found. An earlier report found that FDA does not even have the phone numbers and addresses of many of the facilities it regulates that are supposed to be registered. Download the report here [PDF]. You might need some Xanax, however, if these kinds of things impact your nerves.

According to CDC estimates that are probably on the low side, because these are based on old statistics and poor, often verbal reporting, each year about 47,000,000 people are sickened, 325,000 hospitalized and 5,000 killed due to foodborne illnesses.

In March of 2009, President Obama established the Food Safety Working Group, which was an effort to coordinate all the agencies that monitor food. The President referred to foodborne disease as a "public health crisis" in his announcement of the new group. But the administration has shifted its attention about food-related public health crises to child obesity, in the ensuing year, apparently. The movement to improve food safety has been slow, even as recalls have continued in every sector, whether regulated by USDA or FDA. As a side note, the President recently made a bevy of recess appointments for nominees whose confirmations had been held up by the Senate, but that of Dr. Elizabeth Hagen, his choice for USDA's Under Secretary for Food Safety, wasn't included. She's still awaiting confirmation, and USDA has been without a food safety honcho since December of 2008. But back to FDA.

"If the FDA does not routinely inspect food facilities, it is unable to guarantee that these facilities are complying with applicable laws and regulations," the inspector general noted in the new report.

Government officials are blaming the "problem" on inadequate staffing and funding.

Last July, the House passed a Bill that provided the most comprehensive food safety revamp in fifty years, which included new enforcement powers and funding for FDA. But the equivalent Bill, S. 510, the FDA Food Safety Modernization Act, has been languishing in the Senate, with zero movement for months.

Michael R. Taylor, the FDA's deputy commissioner for foods, told the Washington Post that the Inspector General's report makes the case for the bill's passage.

"We need legislation that will direct us and empower us to be proactive, not reactive," Taylor said. "The legislation pending in Congress will open up entirely new and much more effective ways to do prevention."

Proactive is a good idea, since reactive has led to the current state of affairs. S. 510 amends the Federal Food, Drug, and Cosmetic Act (FFDCA), to expand the authority of the Secretary of Health and Human Services--currently Kathleen Sebelius--to regulate food, and includes the ability to suspend the registration of food facilities that harm consumers.

But at a moment in human history when foodborne diseases can rapidly kill or permanently disable people, there are still no provisions for criminal prosecutions for those corporations and individuals who repeatedly poison consumers with food. An army of trained inspectors is needed, and the current tough economy--and bloated government deficit--argues against that. Even with more inspectors, the rate of inspection will still be low, and also often rely on self reporting. If FDA is currently inspecting less than half of registered facilities, it will take years to get up to speed.

More changes that S. 510 provides for:

The Act requires each food facility to evaluate hazards and implement preventive controls. The Act directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; and (3) the voluntary qualified importer program.

The Act requires the Secretary and the Secretary of Agriculture to prepare the National Agriculture and Food Defense Strategy.

The Act requires the Secretary to: (1) identify preventive programs and practices to promote the safety and security of food; (2) promulgate regulations on sanitary food transportation practices; (3) develop a policy to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; (4) allocate inspection resources based on the risk profile of food facilities or food; (5) recognize bodies that accredit food testing laboratories; and (6) improve the capacity of the Secretary to track and trace raw agricultural commodities.

The Act requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems.

The Act authorizes the Secretary to order an immediate cessation of distribution, or a recall, of food.
The Act requires the Administrator of the Environmental Protection Agency (EPA) to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.

The Act provides for: (1) foreign supplier verification activities; (2) a voluntary qualified importer program; and (3) the inspection of foreign facilities registered to import food.