The U.S. Food and Drug Administration (FDA) is responsible for protecting the safety of much of the food supply reaching U.S. consumers, regardless of whether the food is produced domestically or imported. FDA’s food-safety responsibilities have become more challenging as the United States steadily increases the amount of food it imports.
During the period between 2002 and 2010, the number of instances (entry lines) of imported food nearly doubled, climbing from 4.4 million to 8.6 million import lines. As of 2011, about 15% of all food products consumed in the United States were imported. For certain food products, the proportion of imports is greater: approximately 20% of fresh vegetables, 50% of fresh fruit, and 80% of seafood consumed in this country are imported. As food sources become more global, supply chains have become increasingly complex.
In 2011, Congress enacted the FDA Food Safety Modernization Act (FSMA), recognizing the unique challenges faced by FDA in the area of food safety in the 21st century. FSMA directs FDA to build a new food-safety system based on the public health principle of comprehensive prevention, an enhanced focus on risk-based resource allocation, and partnerships across the public and private sectors to minimize hazards from farm to table.
Section 305 of FSMA calls on FDA to develop a comprehensive plan to expand the technical, scientific, and regulatory food-safety capacity of foreign governments and their respective food industries in countries that export foods to the United States. The plan meets the Section 305 requirement by incorporating FSMA’s principles of comprehensive prevention, risk-based resource allocation and partnering.
The plan provides a strategic framework for FDA’s international food-safety capacity-building activities. It outlines goals, objectives, and key actions that will provide a framework for FDA in setting priorities and managing international food-safety capacity building programs. The plan also will enable all stakeholders to see the breadth of food-safety capacity-building efforts on the part of FDA. It charts a direction for how FDA will prioritize its capacity-building efforts based on risk, coordinate with other partners to avoid duplication of efforts, and to broaden the reach of technical assistance and capacity-building efforts. FDA will use data to develop strategies, allowing the agency to make decisions about capacity-building based on identifiable needs, while also allowing the agency to measure the impact of its efforts.
The plan addresses the six elements required by Section 305 of FSMA by incorporating them into four key goals and objectives, as supplemented by additional themes:
1. Ensure efficiency across the FDA Foods and Veterinary Medicine Program;
2. Increase effectiveness through evidence-based decision-making;
3. Support the exchange of information between FDA and other foreign government agencies or other entities; and
4. Enhance technical assistance and capacity-building in food.
