Need to Know

• FDA found Indonesia’s Cs-137 import certification program is now substantially meeting agency requirements and will maintain MFQAA and BPOM as certifying entities for shrimp and spices, respectively
• The import certification program was launched after FDA detected radioactive Cs-137 contamination in shipments of Indonesian shrimp and cloves in 2025, marking the agency's first use of this FSMA authority
• FDA identified deficiencies for each certifying entity, which have since been corrected: MFQAA improperly composited shrimp samples, while BPOM scanned spice pallets for less than the required minimum time
• FDA also identified four improvement opportunities for MFQAA and nine for BPOM, which have also been addressed by the certifying entities, including certificate management, laboratory reporting, equipment calibration, scanning documentation, and other program controls
• All three laboratories supporting the certification program met FDA testing requirements, with no deficiencies identified

Indonesia’s Marine and Fisheries Quality Assurance Agency (MFQAA) was designated as the CE for shrimp and shrimp products, and the Indonesian Food and Drug Authority (BPOM) was designated as the CE for spices. The agencies are responsible for providing shipment-specific assurances that covered products are not contaminated with Cs-137 before export to the U.S.

Based on its assessment, FDA will maintain MFQAA and BPOM as the certifying entities for Indonesian shrimp and spice products, respectively, covered by the Cs-137 import certification program. FDA said it will continue monitoring implementation and conduct additional assessments as needed.

Import Certification Program Launched After ‘Radioactive Shrimp’ Incident 

The assessment was initiated after FDA’s 2025 detection of Cs-137, a radioactive contaminant, in shrimp, and later in cloves, imported from Indonesia. In response, FDA issued Import Alert 99-52 and, beginning October 31, 2025, required import certification under Section 801(q) of the Federal Food, Drug, and Cosmetic Act for certain shrimp and spice products from specified regions of Indonesia. The action represented FDA’s first use of the import certification authority provided by Congress through the Food Safety Modernization Act (FSMA).

Cs-137 is a human-made radioactive isotope. The primary health concern associated with longer-term, repeated low-dose exposure to Cs-137, including through contaminated food or water, is an increased cancer risk resulting from DNA damage. FDA’s Derived Intervention Level for Cs-137 is 1,200 becquerels per kilogram (Bq/kg). Although the cesium-contaminated shrimp and clove imports fell below the 1,200 Bq/kg intervention level, FDA noted that repeated exposure below that level could potentially pose a human health risk, and took action accordingly.

Indonesian Authorities Corrected Sampling, Scanning Deficiencies Noted by FDA

From May 4–8, 2026, FDA assessed the implementation of the certification program through meetings with the CEs; onsite evaluations at six shrimp processing establishments and five spice processing establishments in Banten, West Java, and East Java; and visits to three laboratories performing Cs-137 testing. FDA also reviewed records associated with selected certificates and observed scanning and sampling activities.

For MFQAA, FDA identified a deficiency in its shrimp sampling procedure. MFQAA had collected samples from each container and composited samples from ten consecutive containers for analysis. FDA requirements instead called for sampling the first container prepared by each manufacturer or processor, followed by one sample for every eight to ten containers.

MFQAA revised its procedure so that one individual sample is collected from a selected container representing a maximum of ten scanned containers, eliminating composite sampling. FDA considered the correction satisfactory.

FDA also identified four opportunities to improve MFQAA’s program involving management of draft and final certificates, documentation of scanning-device acquisition settings, calibration and background measurement documentation, and direct reporting of laboratory results to MFQAA. The agency determined that MFQAA satisfactorily addressed all four recommendations.

For BPOM, FDA found that operators using FLIR R425 radiation detectors had scanned spice pallets for ten minutes, or 2.5 minutes per side, rather than the required minimum of 12 minutes, or three minutes per side. BPOM attributed the discrepancy to an error in a supporting document and revised its scanning protocol to specify the correct scanning times and detector settings. FDA considered the deficiency satisfactorily addressed.

FDA additionally identified nine opportunities to improve BPOM’s certification program, including the tracking and reporting of laboratory results, certificate management, instrument calibration and quality control, scanning documentation, product rejection procedures, and procedures for evaluating inconclusive radiological signals. BPOM revised its procedures in response, and FDA considered the improvements satisfactory.

Cs-137 Testing Laboratories Met FDA Requirements

FDA also evaluated three laboratories used by the certification program: the National Research and Innovation Agency (BRIN), the BAPETEN Environmental Laboratory, and the BUSPM laboratory.

All three maintained ISO/IEC 17025-accredited radiochemistry facilities capable of measuring gamma-emitting radionuclides, with gamma spectrometry included within their accreditation scopes. FDA identified no deficiencies related to applicable laboratory requirements.