Congress gave the FDA import certification authority under section 801(q) of the Federal Food, Drug, and Cosmetic Act through the Food Safety Modernization Act. This tool allows the FDA to require certification or other assurance that imported food meets U.S. requirements before the food can leave the port of export for shipment to the U.S. The FDA may use this authority to address ongoing and repeated food safety problems through additional oversight before shipment. This approach works alongside current tools to cover larger volumes of trade while maintaining safety oversight. Import certification supports foreign firms’ abilities to bring compliant products to U.S. markets while keeping potentially contaminated products out of the U.S.
The FDA is taking this action to require import certification after U.S. Customs and Border Protection detected high levels of Cesium-137 in multiple shipments of shrimp and in a sample of cloves from certain regions of Indonesia and the FDA’s laboratory confirmed contamination in food samples, in addition to other evidence and information reviewed by the FDA.
Import certification is a complementary tool that works alongside FDA’s existing import authorities in the Import Process, like Import Alerts. The FDA is using an Import Alert to communicate FDA’s import certification authority.
IMPORT ALERT #99-52, “DETENTION WITHOUT PHYSICAL EXAMINATION OF CERTAIN HUMAN FOOD PRODUCTS FROM CERTAIN REGIONS IN INDONESIA SUBJECT TO THE REQUIREMENT OF IMPORT CERTIFICATION PER SECTION 801(Q) requires certification for:
- Shrimp from the Island of Java and Lampung Province on the Island of Sumatra in Indonesia
- Spices from the Island of Java and Lampung Province on the Island of Sumatra in Indonesia.
The Import Alert creates a tiered approach with different certification requirements based on contamination risk levels, ensuring that products with appropriate certifications can continue to enter U.S. commerce while preventing potentially contaminated products from reaching consumers.
Resources for Stakeholders
The new import certification webpage provides additional information about this authority, including when FDA may use it, the certification process, and how it complements existing import oversight tools.
Additional Resources
- FDA Response to Imported Foods Potentially Contaminated with Cesium-137 | FDA
- Import Certification
- Import Alert 99-52
- Import Alert 99-51
- FDA Food Imports and Exports: Importing Food Products into the United States | FDA
- Accredited Third-Party Certification Program: FSMA Final Rule on Accredited Third-Party Certification | FDA
Posted in FDA and USDA Regulatory Update.