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FDA Develops Plan for International Capacity Building Under FSMA

Mar 06, 2013

The Food Safety Modernization Act requires the Food and Drug Administration to develop a comprehensive plan to expand the technical, scientific and regulatory food-safety capacity of foreign governments and the food industries in countries that export food products to the United States. FDA recently released the International Food Safety Capacity-Building Plan to outline the agency's strategic framework for setting priorities and managing international food safety capacity-building programs.

IDFA has advocated for FDA to work with foreign governments to ensure the safety of the products that are made outside the United States and imported to be sold here or used as ingredients in U.S. products. 

"A number of finished dairy products are imported into the United States and sold for consumer consumption, and numerous ingredients that are foreign sourced are incorporated into U.S. dairy products. That list includes spices, vitamins, cocoa, vanilla, juice concentrates and many others," said Clay Detlefsen, IDFA vice president of regulatory affairs. "As FDA increases it capacity to work with foreign governments, the entire globally connected food system will become stronger and safer."

In the plan, FDA acknowledged that effective implementation will require collaboration with food industry representatives, officials from other agencies, foreign government officials and non-governmental organizations that represent the interests of consumers, among others.

The plan includes:

  • Recommendations for bilateral and multilateral arrangements and agreements, including providing for responsibilities of exporting countries to ensure food safety;
  • Provisions for secure electronic data sharing;
  • Provisions for mutual recognition of inspection reports;
  • Training of foreign governments and food producers on U.S. requirements for safe food;
  • Recommendations on whether and how to harmonize requirements under the Codex Alimentarius; and
  • Provisions for multilateral acceptance of laboratory methods and testing and detection techniques.

View FDA's International Food Safety Capacity-Building Plan (PDF: 5.7MB).

The capacity-building plan is only one part of the FSMA requirements regarding food safety related to imports. The others are:

  • Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe;
  • Third-party certification: FSMA directs FDA to establish a program through which qualified third parties can certify that foreign food facilities comply with U.S. food-safety standards;
  • Certification for known food-safety risks: FDA has the authority to require that imported foods with a known food-safety risk be accompanied by a certification or other assurance of compliance as a condition of entry into the United States.
  • Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities.
  • Authority to deny entry: FDA can refuse entry of food from a foreign facility into the United States if the facility or the country in which the facility is located refuses to permit entry of FDA inspectors to inspect the facility.

For more information, contact Detlefsen at


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