Import Certification Requirements Take Effect Under Import Alert 99-52 for Shrimp and Spices from Certain Regions in Indonesia

Background on Import Certification Requirements

As explained in detail in our October 6 memorandum, FDA announced on October 3, 2025, that it would begin requiring import certifications for shrimp and all spices from Island of Java and Province of Lampung on the Island of Sumatra in Indonesia based on the risk of potential contamination with Cs-137¹. The agency took this action following detection of Cs-137 in separate shipments of shrimp and cloves from Indonesia.² This is the first use of the import certification statutory authority, which was established in 2011 through the FDA Food Safety Modernization Act amendments to the Federal Food, Drug, and Cosmetic Act.

FDA established these import certification requirements through the publication of 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)³. The import certification requirements established under Import Alert 99-52 are structured into two categories:

• Yellow List: The “Yellow List” identifies certain foods from certain regions in Indonesia for which there may be contamination with Cs-137. All shrimp and all spices from the Island of Java and Province of Lampung on the Island of Sumatra are currently on the Yellow List. All shipments of covered foods are required to have shipment certification from a designated CE prior to export to the U.S.
• Red List: The “Red List” identifies specific firms for which there is evidence of contamination with Cs-137 in product samples, the facility processing environment, or for which there is available information indicating food may have been contaminated with Cs-137. The firms on the Red List also appear on Import Alert 99-51 (Detention Without Physical Examination of Human Food Products That Appear To Have Been Prepared, Packed Or Held Under Insanitary Conditions Resulting in Chemical Contamination)⁴. Food from these firms will not be admitted, even with an import certification from the CE.

Import Certification Procedure

Firms exporting shipments of foods on the Yellow List on Import Alert 99-52 to the U.S. now must contact the appropriate CE to undergo the required screening and sampling and obtain the required certification prior to exporting these foods to the U.S. As noted above, the CE for shrimp is MFQAA⁵ and the CE for spices is BPOM⁶.

The CE is responsible for implementing scanning and analytical protocols for Cs-137 detection that address the following requirements:^7,8 

• Scanning: All food on the Yellow List of Import Alert 99-52 must be screened, prior to loading on shipping containers, with a handheld Radioisotope Identification Device (RIID). Readings above “background levels” are not eligible for export to the U.S. FDA must be notified about such readings, as well as readings “above background” for other radionuclides, except for Potassium-40.^9,10
• Finished Product Testing: Samples must be collected from the first container prepared by each manufacturer/processor and thereafter for every 8-10 containers from the same manufacturer/processor. The sample must be submitted for Cs-137 analysis to an ISO/IEC 17025 accredited laboratory using the recommended laboratory method WEAC-RN-Method.3.0. Analytical results above the Cs-137 Limit of Quantification (LOQ) of <8 Bq/kg render the shipment ineligible for export to the United States. Additionally, FDA must be notified if testing identifies Cs-137 above the LOQ.

FDA also has established certain data elements that must be included on the certificates issued by a CE and procedures for submission of the import certificates.^11,12 FDA, MFQAA, and BPOM will continue to work together to resolve and improve technical and operational procedures that impact implementation of the import certification.

Note that FDA plans to provide alternative screening procedures for shipments that were on the water on or before Monday, October 13, 2025, that arrive in the U.S. on or after October 31, 2025. The agency is taking this action because such shipments were already in transit within a short period of time after FDA announced the import certification requirements (i.e., it was not possible to obtain an import certification or to stop the shipments when the requirement was announced).

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We will continue to monitor implementation of Import Alert 99-52. Please do not hesitate to contact us if you have questions on this or any other matter.

Authored by Maile Gradison and Rachel Buff.