FDA Requires Import Certification for Certain Shrimp and Spices from Indonesia

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) will require import certification for shrimp and spices from certain regions of Indonesia based on the risk of potential contamination with Cesium-137 (Cs-137), effective Oct. 31.

Cs-137 is a radioisotope of cesium that is man-made through nuclear reactions. Because it is widespread worldwide, trace amounts of Cs-137 can be found in the environment, including soil, food and air, said FDA.

This represents the first use of this Congressional authorized tool to address ongoing food safety problems while keeping trade flowing for products that meet certification requirements, said the agency.

In addition to issuing Import Alert #99-52, which outlines FDA’s risk-based determination and notice of the implementation of the new requirements, the FDA published a new webpage explaining its import certification authorities.

The action follows recent recalls on shrimp contaminated with Cesium-137 and processed by PT. Bahari Makmur Sejati (doing business as BMS Foods) of Indonesia.

The FDA said U.S. Customs and Border Protection also detected high levels of Cesium-137 in a sample of cloves from certain regions of Indonesia.

FDA Receives Import Certification Authority from Congress.

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 (FSMA). 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. Import certification supports foreign firms’ abilities to bring compliant products to U.S. markets while keeping potentially contaminated products out of the U.S., said FDA.

Affected Foods.

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, said FDA.

Resources for Stakeholders.

The new import certification webpage provides more information about this authority, including when FDA may use it, the certification process and how it complements existing import oversight tools, said the agency.