The FDA must communicate more clearly with health care professionals and consumers during foodborne illness outbreaks and food safety recalls, according to a report(www.nap.edu) released June 8 by the Institute of Medicine and the National Research Council
The report estimates that 76 million foodborne illnesses occur each year in the United States, resulting in 300,000 hospitalizations and 5,000 deaths.
There has been a series of widespread foodborne illness outbreaks in recent years, including illness caused by spinach contaminated with Escherichia coli O157:H7 in 2006, imported peppers contaminated with Salmonella serotype Saintpaul in 2008 and peanut butter contaminated with Salmonella serotype Typhimurium last year.
In 2008, Congress asked the FDA to contract with the National Academies to produce a comprehensive study of gaps in the agency's food safety system. The result is a nearly 500-page report that recommends that the agency work with its local, state and federal regulatory partners -- as well as with other stakeholders -- to develop a comprehensive strategic plan for the development and implementation of a risk-based food safety management system.
The report lauds a website(www.foodsafety.gov) launched last year that consolidates food safety information produced by federal agencies that have a role in the regulation of the food supply -- including the FDA -- and that provides the public with information about food safety alerts, proper food preparation, causes of food poisoning and its prevention, and how state and federal agencies respond to foodborne illness outbreaks.
The report, however, also says messaging used during food recalls has been ineffective.
A Rutgers University survey(foodpolicy.rutgers.edu) cited in the report found that only 60 percent of Americans reported ever having looked for recalled food in their homes, and only 10 percent reported ever having found recalled food at home. More than 10 percent reported having eaten food they thought had been recalled.
"Despite awareness of recent food recalls, an illusion of invulnerability and a lack of knowledge about the food recall process appear to be widespread among American consumers," the report says. "These findings signify the need for a clear, coordinated and centralized communication strategy for food recalls."
The report recommends that the FDA improve its understanding of the knowledge and behavior of industry, health professionals and consumers with respect to food safety and explore new mechanisms, such as public forums, for expanding its use of strategic partnerships and collaborations.
"Severe food-related adverse clinical events are almost always detected in the clinical care system," the report says. "Such patients need to be identified, treated and reported to public health agencies, again necessitating effective communication channels."
In addition to highlighting this detection and surveillance role, the report points out the critical role physicians play in managing patients with conditions that place them at increased risk of harm from contaminated foods, as well as those who consume special diets to control chronic illnesses.
In both cases, says the report, "the FDA and other federal agencies have an important role in communicating about food-related risks to primary care, specialty and dietetic professionals who specify diets for such patients."
The document also discusses other areas of the FDA's food safety responsibilities, leveling some fairly harsh criticisms of the agency's current reactive, rather than proactive, approach. In short, the report says the FDA lacks the staff, infrastructure, resources and funding to adequately protect the nation's food supply and must make large-scale changes to fix a wide range of problems.
The agency is responsible for regulating 80 percent of the nation's food supply, or roughly $450 billion worth of food annually. It also regulates 150,000 food facilities, more than 1 million restaurants and retail food establishments, more than 2 million farms, and millions of tons of imports.
However, inadequate staffing and funding result in only a small fraction of the food supply being subject to inspections. The report suggests that the FDA delegate more inspection duties to state and local agencies and work with third-party auditors to increase the number of inspections conducted.
According to the report, data collection is another shortcoming of the FDA. The report's authors call for the creation of a centralized, risk-based food safety data collection center capable of rapidly assessing risks.
The FDA lacks the infrastructure and analytical expertise to use data to pinpoint where in the supply chain the greatest potential for contamination exists, says the report. Such information would allow the agency to focus its limited resources on high-risk products and increase the chances of preventing outbreaks.
The report also calls on Congress to expand the FDA's authority in several areas and allow it to:
- suspend registrations for violations that threaten the public health and mandate re-registration of such food facilities;
- mandate preventive controls for all food facilities;
- issue enforceable performance standards,
- gain access to additional food company records;
- force mandatory recalls;
- identify countries with inadequate food safety systems and ban all imports from such countries.
The House passed food safety legislation last summer. Similar legislation was introduced last year in the Senate, but it has not faced a vote. If the legislation(www.fda.gov) is enacted, it would address some of the report's recommendations, including giving the FDA mandatory recall authority and increased access to company records.