Why did the FDA develop a food protection plan?
Societal and demographic changes, the globalization of the food supply, new threats and communication issues require a new approach to food protection. In May 2007, U.S. Department of Health and Human Services Secretary Michael O. Leavitt and Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, charged the FDA with developing a comprehensive Food Protection Plan to address both unintentional and deliberate contamination of the nation's food supply.
Why is the FDA issuing its own food safety plan? Isn’t food safety part of the Import Safety Action Plan?
The Food Protection Plan is integrated with the Administration’s Import Safety Action Plan. The Food Protection Plan, which focuses on both domestic and imported food, is a comprehensive three-part plan that uses science and a risk-based approach of prevention, intervention and response to ensure the safety of domestic as well as imported foods eaten by American consumers. This plan will help strengthen FDA’s role as well as support the Agency’s ongoing collaboration with other federal agencies that have a role in the safety of our nation’s food supply, such as the Centers for Disease Control and Prevention and the USDA’s Food Safety and Inspection Service.
What strategy does the food protection plan propose to better protect the U.S. food supply?
This approach is built on three core elements: Prevention, Intervention, and Response. Prevention from the start of the food cycle is the key to reducing food-borne contaminants from reaching consumers. Prevention, combined with intervention, will reduce the likelihood that contaminated products will reach the consumer. Prevention and Intervention are augmented with faster and focused Response once a problem occurs.
What new legislation does the Food Protection Plan recommend?
The plan recommends that FDA request additional regulatory authorities to increase its capability to effectively address the three elements of the Food Protection Plan and meet the expectations of the American public.Prevention
- Allow FDA to require preventive controls against intentional adulteration by terrorists or criminals at points of high vulnerability in the food chain
- Authorize FDA to issue additional preventive controls for high-risk foods
- Require food facilities to renew their FDA registrations every two years and allow FDA to modify the registration categories
- Authorize FDA to accredit highly qualified third parties for voluntary food inspections
- Require new reinspection fee from facilities that fail to meet current Good Manufacturing Practices (cGMPS)
- Empower FDA to require electronic import certificates for shipments of designated high-risk products
- Require new Food and Animal Feed Export Certification Fee to improve the ability of U.S. firms to export their products
- Authorize FDA to refuse admission of imported food if FDA inspection access is delayed, limited or denied
- Empower FDA to issue a Mandatory Recall if voluntary recalls are not effective
- Give FDA enhanced access to food records during emergencies
What changes will the FDA implement to better protect our food supply?
The plan proposes numerous steps to meet the goals of the three basic components. The actions include, for example:
- Meet with states and consumer groups to solicit their input on implementing preventive approaches to protect the food supply
- Develop written food protection guidelines for industry to develop food protection plans for produce and other food products and implement other measures to promote corporate responsibility
- Analyze food import trend data and integrate it into a risk-based approach that focuses inspection resources on those imports that pose the greatest risk
- Improve FDA’s presence overseas
- Focus food and feed inspections and sampling based on risk
- Train FDA and state investigators on new, technically complex and specialized food manufacturing processes, as determined by a risk-based needs assessment, and modern inspection strategies
- Collaborate with foreign authorities to reduce potential risk of imported foods
- Enhance data collection, incident reporting and emergency response capabilities
- Work with stakeholders to implement a more effective trace-back process, using technologies to rapidly and precisely track the origin and destination of contaminated foods, feed and ingredients
- Work with communications and media experts to design and conduct consumer communications and behavior response studies
- In a food-related emergency, implement this communications plan, including using all relevant media and technologies available, to reach consumers, retailers, industry, public health officials and other stakeholders
Are there more food-borne illnesses today than there were in the past?
There is no solid evidence that the total number of food-borne illnesses have increased in recent years.
What are the common symptoms of food-borne illnesses?
The symptoms of food-borne illness range from mild gastroenteritis to life-threatening neuralgic, hepatic and renal syndromes. These extend from short-term discomfort to hospitalization and even death.
How soon will the FDA start implementing the Food Protection Plan?
Implementation of the Food Protection Plan will begin immediately, be phased in over time and integrated with the Administration’s Import Safety Action Plan.
Why is FDA requesting authority to require mandatory preventive controls for intentional contamination now?
Since the terrorist attacks of Sept. 11, 2001, FDA has solidified its initial work analyzing security in the food sector using a risk assessment tool known as CARVER+Shock. By requiring some practical food defense measures at specific points in the food supply chain, we can increase the security of the food supply. This process will be accompanied by significant opportunity for public comment and input and take into account the best available understanding of the uncertainties, risks, costs and benefits associated with alternative options.
Will FDA be able to prevent food-borne illnesses with this plan?
FDA will never be able to prevent 100% of food-borne illness. However, prevention is the keystone of this food protection plan and building prevention in up front is critical to better ensure safe food. This plan will further develop tools and science necessary to better understand where vulnerabilities are and the most effective ways to minimize them.
How can FDA determine the food areas at greatest risk?
All risk-based approaches must be based on science. The plan addresses the food product life cycle, from production to consumption. By analyzing data collected throughout the life cycle of domestic and imported food, FDA is better able to detect risks posed by food products as well as the key points where those risks can be reduced or eliminated through timely intervention.
FDA is developing a risk-based approach that accounts for variables such as:
- The likelihood that a certain food caused the illness
- The severity of the illness
- The point in the production process where contamination is most likely to occur
- The steps taken during production to reduce the likelihood of contamination.
When it comes to imported foods, how will the FDA focus on ‘Prevention?’
The concept is to “push the border out” and build safety in at the point of production and manufacture in other countries. FDA plans to work with the governments of other countries, industry and other partners to ensure that foods produced outside the U.S. provide the same level of protection as domestically-produced food.
How will the FDA intervene to eliminate risks in the U.S. food supply?
Prevention is the key. To enforce preventive measures to drastically minimize risk, FDA will conduct targeted inspections and testing based on risk and using advanced science and technology of the 21st century. New detection technology is being designed for field use to allow for faster turn around of samples.
As part of its risk-based intervention, what action is FDA planning to take against companies that do not implement preventive controls?
FDA could use its existing enforcement tools, such as untitled and warning letters, seizure, injunction and criminal prosecution for failure to implement any preventive controls that are mandatory.
How does the FDA receive word of a potential problem?
There are a variety of ways the FDA is alerted to potential problems with products: consumer complaints, inspection data, test results, adverse event reports and reports of illness. We might also receive word of a problem from industry, one of our state or federal partners or from governments of other countries.
How does FDA plan to improve response time to the consumers when there is an outbreak or recall?
By improving FDA’s ability to detect early signs of problems combined with improved data integration and the development of more response teams at a state level FDA will be able to respond faster. FDA will also look for better ways to communicate with consumers and retailers during food emergencies.
What is the FDA doing to improve the communication among other federal and state agencies to ensure the safety of U.S. food products?
The FDA communicates regularly with other federal agencies that are involved in safeguarding the U.S. food supply including USDA, DHS, and CDC. FDA also communicates on a regular basis with the states through quarterly 50-state conference calls and as needed as a result of emergencies, food-borne outbreaks or significant events through our Division of Federal–State Relations. Other federal agencies such as USDA, CDC, and DoD are invited to participate in these calls. FDA has regular interactions with CDC regarding ongoing food-borne illness situations and surveillance that is facilitated by having an on-site FDA liaison situated at CDC in Atlanta.Communications such as recalls, FDA press releases, health alerts and significant state notices are broadcast through the SAFE system (State Advisory Fax-Email system) to over 2,500 fax/email addresses. Today, more than 10,000 state food contract inspections are entered into the eSAF (electronic State Access to FACTS) and FDA is working with the states to determine ways to enter and access another 40,000 inspections conducted by the states under their state laws and programs. The use of other state data for risk management and enforcement to complement FDA data also is under consideration. In addition, FDA is piloting the Manufactured Food Regulatory Program Standards, a set of best practices for state regulatory programs, with five states in FY08 with expansion planned to all state contract programs by 2011.
What are some of the new scientific advances that will be used to improve response time in handling food-borne illnesses?
The development of new technology, along with the implementation of technology that is already in development, will allow inspectors to identify risk-based factors faster. These tools include real-time diagnostic instruments and methods that allow for rapid, on-site analysis of a particular sample. This type of technology could, in some cases, reduce analysis time from days to minutes.
What role will other agencies have in protecting the food supply (USDA FSIS, CDC, NOAA, etc.)?
While FDA has responsibility for all types of food with the exception of meat, poultry and egg products, which are under the jurisdiction of the Department of Agriculture (USDA), protecting the food supply has always been an integrated approach across multiple federal agencies. The Food Protection Plan addresses FDA’s role but will require the continued integration and interaction with multiple federal, state and local regulatory authorities.
Is FDA asking for authority to require that a stamp of approval be placed on all imported products?
No, FDA is seeking authority to require certificates of compliance with FDA standards for designated products from specific countries based on agreements with those countries. Products will be designated for such a certificate requirement based on risk.
How will the proposed new authorities extend FDA’s presence on farms?
FDA currently has authorities applicable to food on farms, such as its authorities to perform inspections and seize food. With the exception of specific situations related to preventing deliberate contamination of food (i.e., milk) FDA is not requesting new authority that will extend FDA's presence on farms.