Building a Modern Food Safety System at FDA
Key Reforms Congress Should Include in Food Safety Legislation
Nationwide outbreaks in recent years have exposed serious gaps in our system for protecting the public from foodborne disease, prompting calls for reform from industry and consumers. Each year millions of Americans suffer a foodborne illness, many serious enough to require hospitalization and thousands ending in premature death. The elderly, people with compromised immune systems, pregnant women, children, and infants are most at risk of serious illness, but everyone is at risk since many pathogens, including Salmonella, Campylobacter and pathogenic E. coli can lead to chronic illness and reduced life expectancy.
Efforts at the Food and Drug Administration (FDA) to reduce the enormous cost of foodborne illnesses are hampered by the 70-year-old law the agency operates under. FDA’s antiquated statute is out of step with modern food safety regulation. Congress needs to modernize the nation’s food safety law using a program based on prevention.
To fix FDA Congress must adopt legislation that addresses deficiencies in 11 critical areas by establishing (1) process controls implemented by industry, (2) performance standards set by FDA, (3) more frequent inspection schedules, (4) better import controls, (5) stronger research and education programs, (6) an on-farm food safety mandate, (7) mandatory recall authority, (8) traceback systems, (9) administrative detention authority, (10) authority to issue civil penalties, and (11) protection for whistleblowers.
Process Controls & Performance Standards to Prevent Outbreaks and Recalls
The heart of a modern food safety system lies in preventing – not merely responding – to food safety problems. Mandatory process controls, coupled with government-enforced performance standards, should be the central features of a new system. These systems can be used from farm-to-table and with both domestic and imported foods.
Most foodborne illnesses are the result of contamination that occurs during production, processing, shipping, or handling. These lapses result in illness, recalls, and loss of public confidence in the safety of our food supply. While in-plant and border inspections form the core of the government’s food safety program, inspection is often little more than a spot check on performance. The reality is that the industry holds the key to addressing and preventing food contamination.
The safety and security of the food supply requires an integrated, system-wide approach to preventing foodborne illness, with oversight by federal food safety agencies. Preventing food contamination can be done using programs of quality assurance and preventive process control, such as Hazard Analysis and Critical Control Points (HACCP), that are developed by individual companies. These programs are already widely used, and they can be incorporated into food production systems at all levels.
HACCP systems are already mandated in some segments of the food supply, including seafood, juice, and all types of meat and poultry products — both raw and processed. A modern food safety system mandated by Congress should require the FDA to implement HACCP or HACCP-like systems for all food processors and tie agency inspections to an audit of these systems. These industry-derived programs should be coupled with performance standards, such as limits on the incidence or levels of contamination, or reductions in pathogen levels, that are established by the government. Monitoring and enforcement of the standards are key elements of inspection in a successful food safety program. This includes laboratory testing to ensure that process controls are working effectively.
Congress should require the FDA to set performance standards based on the best-available science on hazards linked to specific food products and other public health considerations. Standards can also be used to ensure that food is produced in a sanitary manner that limits the likelihood of contamination by pathogens, chemicals, or even physical hazards, like glass or metal. The HACCP and performance-standard approaches would focus food safety activities on prevention and would permit more efficient and effective government oversight through analysis of records as well as visual and laboratory inspection.
Inspections & State/Federal Cooperation
Unlike for makers of drugs and medical devices, the FDA lacks a minimum inspection mandate for the food companies it regulates, and its current staff is able to inspect food plants on average only once every 10 years. These gaps contributed to the massive peanut butter recall in winter 2007 and the canned food recall in summer 2007, as well as many other outbreaks and recalls that might have been prevented with a stronger oversight program.
Inspections. Inspection of commercial food processors is an integral part of the food safety system. It provides an audit of food safety programs managed by the establishments and ensures accountability for meeting food safety performance standards. The FDA is responsible for overseeing approximately 210,000 domestic food establishments. However, the number of field staff has dropped by 12 percent since 2003, which has resulted in significantly fewer inspections. In fact, between 2003 and 2006, FDA food safety inspections have dropped by 47 percent.
Imported foods receive even less oversight from the FDA. Less than one percent of the food imported into the U.S. is inspected. This leaves the nation’s food supply vulnerable to substandard foods from foreign countries where rules and regulations governing food are often more lax. Under the Bioterrorism Act of 2002, Congress gave the FDA additional authorities including requiring foreign manufacturers and shippers to register with the agency. They are also required to alert the FDA when food is being shipped to the U.S.
Despite these additional authorities, the FDA still lags behind the USDA in inspection authority. The USDA is required by law to do continuous inspections at meat and poultry plants. All meat and poultry products must be inspected and approved for sale by the USDA. The Federal Food, Drug and Cosmetic Act does not require pre-market approval for FDA-regulated food products. Additionally, the FDA does not enforce any requirement that foods imported into the U.S. be produced under food safety systems that are equivalent to or better than those used in the United States.
The FDA must have congressionally mandated authority to create a system of risk-based inspection, based on the type of food handled and the processes used. Under this system, food establishments would receive an inspection classification or rating based on public health considerations and scientific evidence to determine the frequency and timing of inspections. All facilities now regulated by the FDA should be subject to a mandatory inspection frequency, with higher risk facilities inspected much more often (e.g. daily, monthly, or quarterly). This system of inspection would allow for the best use of government resources while still providing safety checks along the entire farm-to-fork continuum.
Over all, CSPI believes the inspection program should: Be comprehensive and designed to determine if food establishments have process controls in place and are meeting performance standards; Include product sampling at both domestic and foreign food establishments; and Be based on a risk-based inspection schedule for the food establishments under FDA’s purview and include the authority to go on the farm to address sources of contamination before outbreaks occur.
Federal & state cooperation. State inspection programs are an important component of the nation's food-safety inspection system. The FDA has increasingly relied heavily on states to do inspections of FDA-regulated products because of budget and staff constraints. The agency needs a national food safety plan to assure that state food inspection programs are capable of and in fact provide a level of public health inspection that meets FDA standards. The FDA must have the resources to work with states to carry out food safety activities in a coordinated cost-effective manner. The agency must provide both technical and advisory assistance to the states, while also supporting work on the state level to strengthen inspection programs and recalls.
Each year the average American eats about 260 pounds of imported foods (13 percent of the total diet) that are regulated by the USDA or the FDA. But while the USDA has a multi-tiered, legislatively-mandated program for preventing the importation of unsafe meat and poultry products, the FDA’s program is largely reactive and relies on a thin line of inspection to try to catch problems at the port of entry.
Weaknesses in FDA’s oversight of imports are causing real problems for consumers. Imported fruits and vegetables, for example, have caused numerous large and sometimes deadly outbreaks. Imported berries, melons and green onions, coming from areas with substandard hygiene practices, have sickened thousands of Americans in the last ten years. More recently, contaminated and mislabeled wheat flour incorporated into pet food and animal feed raised real concerns over the safety of animals.
Each year, the FDA inspects less than one percent of the growing number of imported food shipments. Unlike the USDA, the FDA does not review and approve national programs for countries that want to export to the U.S. or even visit the individual plants before they begin shipments. This is quite different from the program for approving imports of USDA-regulated meat and poultry products, where both national food safety programs and plants must be approved prior to shipping and 100 percent of imported shipments are visually checked at the border.
The FDA must have the authority to establish a system under which governments or foreign food establishments seeking to export food to the U.S. can certify their food safety system. This certification should demonstrate that the food they are exporting meets standards of food safety, inspection, labeling, and consumer protection that are at least equivalent to foods produced in this country.
Prior to approving a certification request by a foreign government or firm, the FDA should review and audit its food safety program. The FDA should be able to withdraw certification from a foreign government or firm if a food product is linked to an outbreak of human illness in the U.S., or if the foreign importer no longer meets equivalency standards. Refusing to allow the FDA to conduct routine audits and investigations of facilities should also be grounds for withdrawing certification.
Certification is very different from the open-border approach that is currently used and would provide much greater assurance of safety for consumers. The ultimate goal of a certification program is to have someone that has reviewed the exporting facility’s food safety program and can vouch for it. It is highly likely that companies would develop new mechanisms, like forming into cooperatives, to become an alternative to firm-by-firm certification. Some have also proposed that certification should be voluntary, but provide a faster route to entering U.S. commerce.
The challenges of approving food coming into the U.S. from all parts of the world are certainly enormous. What is critically important is that the imported food be at least as safe as food produced domestically, and that the programs both in the U.S. and overseas control for all likely hazards.
Research and Education
Today, the FDA conducts limited research related to pathogenic microorganisms and other food contaminants. More FDA-directed research is needed, however, to support FDA regulatory programs, state food-safety agencies, and the food industry’s own efforts.
Public health assessment. The current public health system in the U.S. has limited capacity to identify and track the causes of foodborne illness. FoodNET, an active public health surveillance system run by the CDC, is beginning to produce more information on illnesses associated with foods, but this information needs to be shared on a more timely basis with other governmental agencies as well as the public. More thorough outbreak investigations and analysis of available information is needed to identify the root causes of food safety problems and develop preventive interventions. Additionally, a sampling system is required to assess the nature and frequency of foodborne hazards in food. Such investigation and analysis would allow the public health agencies that regulate food to rank products based on risk to human health and help to identify appropriate industry and regulatory approaches to minimizing hazards in food.
Research. Research is a vital tool in the effort to reduce the incidence of foodborne illness and is integral to the programs of all public health agencies. Research is needed to evaluate the effectiveness of control and prevention strategies and to conduct risk assessments. It is also needed to improve sanitation and food safety practices during processing. The FDA and industry must improve techniques to monitor and inspect food and develop efficient and sensitive methods for detecting contaminants and reducing harmful pathogens.
Public education and advisory system. Public education is another essential component of improved food safety. Rates of illness could be reduced if food preparers and handlers were better informed of risks and related safe-handling practices. Educational programs that promote better understanding and practice of proper food-safety techniques, such as thoroughly washing hands and cooking foods to proper temperatures, could significantly reduce foodborne illness. Programs are also needed to help health professionals improve their diagnosis and treatment of food-related illness and to advise individuals at special risk.
Solutions to On-Farm Food Safety Issues
Since 1998, fresh fruits and vegetables have been linked to a large number of outbreaks and associated illnesses. Given the importance of produce consumption to a healthy diet, it is imperative that the FDA take concrete steps to reduce the incidence of foodborne illness associated with fresh produce. While many produce outbreaks occurred prior to 2006, last September’s spinach outbreak provided direct evidence that these problems can originate on the farm and therefore require farm-based solutions. In fact, the FDA traced the exact strain of the E. coli bacteria that made people sick to a California spinach farm, finding it in nearby manure piles, in a creek, and even in a wild pig.
Today, the FDA does not have specific, mandatory standards that apply to farmers who grow food for human consumption. Instead, the agency relies on very general Good Agricultural Practices and other voluntary guidance that is not enforceable under the law.
Due to gaps in the statutes and confusing authority between the FDA and the USDA, Congress must give the FDA a specific mandate to develop and enforce an on-farm food safety program:
- The FDA should require all growers and processors to keep a written food safety plan based on the principles of preventive process control and designed by the farmer to address the specific environmental conditions on the farm.
- The FDA should develop specific, standardized, and enforceable criteria for use by the farmers for such items as water quality, manure use and management, and worker sanitation.
- Processors must mark packaging to ensure easy traceback when fruits and vegetables are implicated in an outbreak. Package markings must be specific enough to extend all the way back to the farm/farms of origin.
- Finally, the written plans should be audited at least once per growing season by the FDA, the states, and/or the buyers (the FDA should review the state and private audits.)
Today, the FDA’s food safety program does not have the modern enforcement tools used by other agencies or even the authorities the agency has to regulate drugs and medical devices. The FDA can take a few limited actions, such as issuing warning letters, urging companies to voluntarily recall product, and getting court-ordered seizures, injunctions, and criminal penalties. These weak tools do not equip the FDA to protect consumers from the threat of foodborne illness. The following new authorities are essential to modernize FDA’s food surveillance and enforcement:
Recalls. Today recalls of contaminated food are voluntary. The Federal Food, Drug, and Cosmetic Act does not give the FDA the power to order a producer to recall a food product, with the exception of infant formula. If a firm does not recall a product, the FDA can go to court to seek an injunction or seizure of the product. But these legal actions waste precious time, and if a food company or importer fails to recall a contaminated product, it can continue to reach consumers. Mandatory recall authority would ensure that recalled foods are removed from the market more quickly and effectively.
Traceback. The FDA needs the authority to identify the source of foods that pose health hazards to consumers. The ability to trace a contaminated product back to the source of production would allow the agency to conduct more rapid and thorough investigations. It would also allow producers to more precisely identify the source of a problem in order to improve production practices and could help narrow the scope of recalls by more quickly identifying the specific plant or country of origin.
Detention. If an FDA inspector has reason to believe that a domestic or imported food is unsafe, adulterated, or misbranded, the agency must have the authority to temporarily detain the food for a reasonable time. If it is determined that the detained food cannot be brought in compliance with food safety requirements, the FDA should be able to condemn the food.
Civil and Criminal Penalties. An essential element of any enforcement capability is the power to penalize manufacturers and producers for violating food safety laws as a deterrent to future violations by the guilty party and others. Food companies must be subject to civil and criminal penalties for violating food safety laws. A person that has been harmed as a result of a violation of food safety law should have the power to commence a civil action.
Whistleblower Protection. Federal employees must be protected from the threat of being fired, demoted, suspended, or harassed as result of providing information or assisting in the investigation of a violation of a food safety law.