U.S. Food and Drug Administration
Performance Plan
2002
Ensure the safety of the food supply, including both imported foods and foods produced in the U.S., by minimizing contamination of food by pathogens, unlawful animal drug and pesticide residues and environmental contaminants.
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Inspect annually all domestic establishments that produce high-risk food products. Implement an imported food safety program that emphasizes inspection of foreign manufacturers and border surveillance of products. Monitor pesticide residues and environmental contaminants through analysis of food samples. |
One of the Federal Government's most important and enduring roles, dating back to the beginning of the 20th century, is the protection of the food supply from such threats as microbial contamination, unlawful animal drug and pesticide residues, and environmental contaminants, such as dioxin. FDA regulates 80 percent of all food consumed in the U.S. Recent estimates indicate that microbial foodborne disease causes approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths each year in the United States. Hospitalization costs alone for these illnesses are estimated at more than $3 billion a year, and costs from lost productivity are much higher. Foodborne illness is preventable, and FDA's food safety activities are crucial to significantly reducing the enormous societal costs related to these illnesses.
FDA is responsible for ensuring the safety of foods produced and distributed by 59,000 domestic food establishments, 1,240 medicated feed mill establishments, and 5.1 million food imports that are expected to cross the U.S. border. Many of these imports come from countries that do not have the regulatory infrastructure to assure the safety of foods they produce.
The task of ensuring a safe food supply has become more difficult because the nature of food and foodborne illness has changed significantly. For example, foods are more technologically complex; the number of foodborne pathogens has increased fivefold in the last 50 years; consumers are eating more seafood, fresh produce, imported produce and other foods, and "convenience" ready-to-eat foods; and our vulnerable populations have increased.
As part of its mandate from Congress to ensure that the food supply is safe and wholesome, FDA is expected to inspect all food manufacturing establishments in the U.S. on a regular basis. The number of inspections conducted by FDA has fallen steadily over the past 25 years (see Figure 1). This decline corresponds to the decline in FDA's investigational work force. Since FDA has always adhered to the principle of addressing the most serious risk first, the Agency has focused its available resources on inspecting establishments that produce high-risk foods as well as those with a history of noncompliance. The U.S. food supply remains among the safest in the world.
Beginning in 1997, FDA has sought new funding to restore the Agency's food inspection capabilities. Congress appropriated some increases in funds in FY 1999, FY 2000 and FY 2001. In addition, the Agency has adopted a number of strategies to address its public health mission including:
If FDA is unable to inspect food establishments to monitor and promote compliance with U.S. food laws and regulations, the Agency will be unable to promote good manufacturing and agricultural practices, ascertain the conditions under which our food is produced, identify manufacturing problems that threaten public health, or work with industry to correct problems that are identified during inspections. In addition, FDA cannot develop test methods to identify hazards in genetically modified foods, drug residues in food, and antibiotic resistant strains of bacteria in food. Thus, FDA will not be able to detect hazards or to do so in a timely and cost-effective manner. As a consequence, public health will be compromised, and the credibility of the U.S. food safety system will suffer. Most importantly, FDA will not be able to play its role in preventing foodborne illnesses, and associated hospitalizations, deaths and losses in productivity.
The absence of test methods to evaluate foods that are more technologically complex and diverse presents new regulatory challenges. In addition, FDA does not have the explicit statutory authority to require registration of all domestic food processing plants. Without a required, descriptive registration of all food firms, we are unable to assess accurately the number and type of establishments that FDA is responsible for regulating. Without this capability, we cannot accurately plan our activities by focusing on those firms that produce high-risk foods. Registration information may result in an increase in the number of firms that are targeted for annual inspection.
Through a combination of FDA and state contract inspections, domestic firms that produce high-risk food products have been inspected on an average of once every three to four years. In FY 2000, 91% of the estimated 6,250 firms that produce high-risk food products were inspected. In 1999, about 90% of domestic seafood firms received a HACCP inspection. In FY 2001 and FY 2002, all high-risk establishments will be inspected. Inspection data for FY 2001 accomplishments will be assessed begin the basis for even better targeting of inspection resources.
The assurance of food safety is best monitored at and by the country of origin. FDA is using several approaches to better utilize existing resources to address safety of imported foods. These are:
The inspections provide FDA not only with an on-site evaluation of a specific foreign firm, but also with a picture of the foreign industry's ability to produce safe food and of that country's food safety system.
Based on these approaches and the compliance documentation provided by importers and audited by FDA, the Agency can focus its resources on border inspection of the highest risk. Many imported foods come from countries that are characterized as emerging economies with emerging regulatory infrastructures. These countries are least able to assure a food safety system equivalent to ours. FDA will develop methods to detect illegal drug residues in imported aquaculture. By working with other domestic and foreign government agencies, we can accomplish more and devote our resources to the highest-risk products.
The volume and variety of food products imported into the U.S. has increased significantly in recent years (see Figure 2). The safety of the U.S. food supply depends on countries exporting to the U.S. assuming more responsibility for preventing foods that do not comply with U.S. safety standards from being exported to the U.S. Without these controls, compliance inspections of foreign manufacturers and appropriate surveillance at the border, FDA can not provide the assurances of safety that the American public has come to expect.
Increased consumption of imported foods, the variety and nature of those foods and the number and variety of countries from which these foods are imported have greatly increased the workload of ensuring the safety of imported foods. Not only are there significantly more products entering at the border but there are also more foreign firms to inspect and more countries' food safety systems to audit. In addition, as for domestic food products, there are no test methods to evaluate hazards in imported foods that are genetically modified, drug residues in food, and antibiotic resistant strains of bacteria in food are lacking.
Because of the lack of explicit statutory authority, FDA does not have an accurate description of the scope of high-risk foods that we can reasonably expect to be imported into the country. In addition, FDA has limited authority to ensure that food imported to the U.S. is produced under food safety measures that are the same or equivalent to ours. Therefore, it is up to the Agency, using border surveillance, to identify problems and to determine corrective actions.
Countries that export to the U.S. do not currently provide FDA with assurance that foods coming to this country are safe. FDA has proposed legislation that would require such assurances but Congress has not adopted the proposed legislation. A small percentage of imported food entries are directly assessed through field examinations and less than 1% through laboratory analysis.
In FY 2000, we increased our surveillance of microbial contamination by completing examination of 1,000 imported produce samples and conducting inspections of foreign produce farms in response to findings of pathogen contamination. In FY 2001, we plan to conduct 250 inspections of foreign food processors. Data on FDA's examination of imported food products and inspections of foreign food establishments will be assessed beginning in November 2001. The results will provide the basis for better targeting our foreign inspection and border surveillance resources. However, at current resource levels, we expect coverage of imported food products will be less than 1% as the volume of imported food products continue to increase.
