Editor’s note: This is the second in a series of articles from Center for Science in the Public Interest Food Safety Director Caroline Smith DeWaal on the implementation of the FDA Food Safety Modernization Act. In the second installment, DeWaal looks at several new enforcement tools – suspension of registration and records access – that emerged from lessons learned from the Bioterrorism Act of 2002.
The effort to modernize the Food and Drug Administration’s (FDA) food safety program began in the late 1990s, following several very large outbreaks linked to raw oysters and imported berries. One outbreak involved berries tainted with Hepatitis A that were processed into a dessert served by the school lunch program, and underscored for consumers our vulnerability. That outbreak sickened over 250 consumers in five states, many of whom were school children.
The first bill titled, “The Consumer Food Safety Act of 1998,” was filed in April of that year by Representative Frank Pallone, with 29 cosponsors, including both Representative Henry Waxman and Representative Rosa DeLauro. While it was a relatively simple bill compared to what finally passed Congress late last year, the legislation contained many of its essential elements, including both registration and process controls.
In 2001, when Congress was grappling with the aftermath of the attack on the World Trade Center, concerns were raised by then-Secretary of Health and Human Services Tommy Thompson that our food supply could become a target. In fact, Thompson told Congress that he was most concerned about food as a target because inspections were not adequate. In response, Congress included a number of food provisions in the Bioterrorism Response Act of 2002, along with $100 million for improvements in inspection and counterterrorism programs. The agency was given authority to register domestic and foreign facilities, detain suspect food items, require prior notice on all imported food shipments, and also required “one up/one down” traceability.
The FDA Food Safety Modernization Act significantly improves the registration provision and adds records access requirements that will be critical to preventing future outbreaks. While registration of food facilities doesn’t sound like a program that will give teeth to the new FDA Foods program, in fact, when coupled with suspension, it gives FDA a powerful new enforcement tool. To understand why, let’s back up and look at the history of the issue.
Prior to 2002, FDA inspectors went into the field not knowing who exactly they should be inspecting. An Inspector General report once noted that FDA inspectors would refer to the Yellow Pages of the local phone book to find food plants in an area. The registration provision was adopted by Congress in order to give the agency a comprehensive list, with names, addresses and contact information for the food plants under its jurisdiction. While the 2002 Bioterrorism Act provided a first step for registration, its implementation by FDA was lackluster, and the database of food plants soon became out-of-date.
The initial registration provision under the Bioterrorism Act required registrants to “notify the Secretary in a timely manner of changes to [registration] information,” and required FDA to compile and maintain an up-to-date list of registered facilities. The new Act is more specific and requires food facilities to re-register between October and December of each even numbered year beginning in 2012.
Authority to suspend the registration of a food facility is perhaps one of the most important enforcement tools the new law grants FDA. It allows the agency to effectively shut down a food facility that is associated with an outbreak of serious foodborne illness. A facility under suspension cannot import, export, or ship food until the business takes corrective action. This provision becomes effective no later than 180 days after enactment of the law or earlier, if regulations are issued by FDA.
The new authority artfully shifts the legal burden between industry and the agency to create incentives for businesses to comply with food safety requirements, while giving the agency real teeth to address non-compliance. To keep FDA from overreaching, the authority to suspend a facility resides with the Commissioner, and businesses are provided an opportunity to contest the suspension within two days of its issuance.
The Commissioner can reinstate the registration when the evidence shows that adequate grounds do not exist for its continuation. Thus, a facility can submit a corrective action plan for FDA’s approval, and once approved, it can begin shipping product again. Suspension authority will be an effective enforcement tool if properly implemented. This provision gives FDA a significant new tool to go along with its broad responsibility to protect the public from unsafe food.
Another treasure in the Act is the records access provisions. To gain access to corporate records under the 2002 Bioterrorism Act, FDA needed evidence of adulteration as well as a serious risk to health or life. It also required that record requests be in writing. This delayed access to critical corporate records during outbreak investigations like one involving peanut butter and led the agency to ask Congress to relax the adulteration requirement. Additionally, the Bioterrorism Act only allowed FDA to access records for the food under investigation, preventing inspectors from following leads to other food lines within the same facility.
The new law gives FDA clear authority to access a facility’s written food safety plan, together with monitoring and test results, during its regular inspections of the food plant. These records must be made available to “a duly authorized representative of the Secretary upon oral or written request.” This will greatly aid the FDA in improving the effectiveness of its inspections. No longer will the agency be doing a simple inspection, reflecting only its findings during the time inspectors are in the plant. Through a random review of records for different days or even weeks, FDA can transition to conducting inspections that reflect activities in the plant over a longer time frame. And during an investigation of an outbreak, the FDA Food Safety Modernization Act provides clear authority to expand an inquiry to other food lines within a facility, provided there is a reasonable belief the food processed on them is affected in the same way as the food under investigation.
The FDA never realized the full benefit of new authorities to oversee and enforce food safety laws it gained in the 2002 Bioterrorism Act. The Food Safety Modernization Act takes lessons learned from a decade of outbreak investigations to give the agency tools for protecting public health. The agency will need to move forward rapidly on regulations to put muscle in and reap the full value of these tools.
U.S. Food and Drug Administration photo