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)

Starting on October 31, 2025, for all spices from Island of Java and Province of Lampung on the Island of Sumatra.

The FDA has made the determination that Cesium-137 (Cs-137) is a known safety risk in certain food from Indonesia and that there is a known safety risk associated with certain regions of origin in Indonesia within the meaning of Section 801(q)(2)(A) and(B) of the Act, respectively. FDA’s determination to require certification under 801(q) is based on information available to the Agency, including information regarding the detection by U.S. Customs and Border Protection (CBP) of elevated levels of Cs-137 in several shipments, including shrimp and cloves, FDA sample analysis confirming the presence of Cs-137 in shrimp and cloves, and known sources of and events of contamination by Cs-137 in the region where the food originated. Potential Cs-137 contamination sources include radioactive contamination discovered in Serpong, Banten Province in 2020, ongoing investigations revealing airborne radioactive debris from metal smelting facilities, and contamination risks identified in the Island of Java and the Province of Lampung in the island of Sumatra.

The FDA is implementing the requirements described in this Alert for Import certifications concerning imported foods under Section 801(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) under the authority provided by the Food Safety Modernization Act (FSMA) Section 303. FSMA was enacted to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. The Agency’s determination to require an import certification was based on the risk associated with the food and the region. When making this determination, we considered the factors set forth in the FD&C Act under Section 801(q)(2). This Import Alert covers certain human food products originating from the region of concern and from firms with products for which FDA has specific evidence of Cs-137 contamination.

FDA has also established a process described in this Import Alert for handling imported human foods that are subject to, but not compliant with, certification requirements or other assurances that the food meets applicable requirements of the FD&C Act, which would result in refusal of admission under Section 801(a) of the FD&C Act.

The certification requirements are structured into two categories:

Red List: Firms on the Red List are those for which there is evidence of contamination with Cs-137 in product samples, the facility processing environment, or for which there is other available information indicating food products may have been contaminated with Cs-137. To be removed from the Red List, firms are required to have an Accredited Third-Party Certification Program (TPP) regulatory audit and certification to verify the control of Cs-137. Once a firm is removed from the Red List, they will remain subject to Detention Without Physical Examination (DWPE) and would need to provide the information indicated below under the Yellow List for each shipment.

Regulatory audits under TPP are intended to verify that the products are being produced in compliance with the FD&C Act and applicable regulations. More specifically, a TPP certification will confirm that the firm has identified hazards, as appropriate, developed appropriate documents (food safety plan; HACCP plan; or practices and controls to prevent Cs-137 contamination) and verify implementation of appropriate controls to prevent Cs-137 contamination.

FDA has provided recommendations related to the controls for the hazard of Cs-137 in letters to the Indonesian Government agencies (Certifying Entities), MFQAA and BPOM, as applicable. The regulatory audit and certification should document that the audited firm has implemented controls for the hazard of Cs-137, that may follow FDA’s recommendations or that provide similar levels of assurance to comply with Section 801(q) of the Act.

Industry and accredited Certification Bodies can find the FDA's letters to the Certifying Entities designated by FDA for IA 99-52 on FDA's website: "FDA Response to Imported Foods Potentially Contaminated with Cesium-137" (https://www.fda.gov/food/environmental-contaminants-food/fda-response-imported-foods-potentially-contaminated-cesium-137#69814b25dff05).

All impacted shrimp processors may consider following FDA’s recommendations regarding the control strategies described in our letter to MFQAA when they are developing and implementing their Cs-137 control programs: https://www.fda.gov/media/189454/download?attachment.

All impacted spice producers may consider following FDA’s recommendations regarding the control strategies described in our letter to BPOM when they are developing and implementing their Cs-137 control programs: https://www.fda.gov/media/189455/download?attachment.

Certificates of assurance from an accredited third-party certification body issued under FDA’s TPP must be submitted directly to FDA. TPP certifications expire no later than one year from the date of issuance. For further information on TPP see: https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program.

Yellow List: Certain foods from certain regions in Indonesia (identified in the product description section) as having known Cs-137 contamination risks are required to have shipment certification from a Certifying Entity (CE), as designated under 801(q)(3)(A).

Shipment-specific certificates issued by the designated CEs should be submitted directly to FDA to assist FDA in its determination as to the reliability and validity of any such certificates. To facilitate direct submission, FDA has provided the available electronic submission process to the designated CEs. Entities such as importers and filers may submit certificates received from a designated CE through the Import Trade Auxiliary Communications System (ITACS) for each entry submission. This ensures FDA can match shipment-specific certificates received directly from the designated CEs to specific entry submissions and verify authenticity with the issuing CE.

FDA may refuse to accept any certification if FDA determines that such certification is not valid or reliable, such as certifications not received directly from a designated CE.

Firms must notify FDA of any operational changes or incidents that could affect contamination risk, including but not limited to changes in raw material sources, or detection of elevated radiation levels in their firm including product manufacturing or holding areas. Recertification may be required based on new contamination events in the region or other information that FDA obtains regarding Cs-137 contamination, and such recertification must be completed within a timeframe determined by FDA based on the severity and scope of the identified risk.

The CEs designated by FDA to provide shipment-specific certification for products listed under the Yellow List of IA 99-52 are identified below. The designated CE is based on the nature of the product being offered for import to the U.S.

Industry should contact the appropriate CE identified below to obtain the required screening and sampling of shipments of food and certification as appropriate and covered under import certification prior to products being exported to the U.S.

- The Ministry of Marine Affairs and Fisheries Quality Assurance Agency (MFQAA) of the Ministry of Marine Affairs and Fisheries (MMAF) of the Republic of Indonesia is responsible for providing shipment-specific certification that certain shrimp products are not contaminated with Cs-137.

To arrange to obtain a certificate from MFQAA for shrimp that is subject to detention without physical examination under the Yellow List prior to exporting the product to the U.S. contact: MFQAA's email address for industry inquiries: mfqaa.idn@kkp.go.id. Point of contact name: Mochamad Aji Purbayu, DVM, M.S.

- Indonesia’s Food and Drug Ministry (BPOM) of the Republic of Indonesia is responsible for providing shipment-specific certification that certain spice products are not contaminated with Cs-137. To arrange to obtain a certificate from BPOM for spice products subject to detention without physical examination under the Yellow List prior to exporting the product to the U.S. contact: BPOM's email address for industry inquiries: pangan.exim@pom.go.id.

For additional information about Certifying Entities see: https://www.fda.gov/food/environmental-contaminants-food/fda-response-imported-foods-potentially-contaminated-cesium-137.