1. Home
  2. Food
  3. Chemical Contaminants & Pesticides
  4. Environmental Contaminants in Food
  5. FDA Response to Imported Foods Potentially Contaminated with Cesium-137
  1. Environmental Contaminants in Food

FDA Response to Imported Foods Potentially Contaminated with Cesium-137

As part of the agency's implementation of import certification for certain foods from certain regions of Indonesia, the agency is designating the Marine Affairs and Fisheries Quality Assurance Agency (MFQAA) of the Ministry of Marine Affairs and Fisheries (MMAF) of the Republic of Indonesia as a certifying entity (CE) for shrimp (and shrimp products) and Indonesia’s Food and Drug Ministry (BPOM) of the Republic of Indonesia as a certifying entity for spices. As the CE, each agency is responsible for providing assurances that the products covered under import certification are not contaminated with Cesium-137.

The FDA detected the radionuclide Cesium-137 (Cs-137) in early August 2025, in one sample of frozen shrimp from Indonesia. In order to protect consumers, the FDA added the firm PT. Bahari Makmur Sejati to a new import alert (Import Alert # 99-51) for chemical contamination to stop shrimp products from this firm from coming into the U.S. until the firm has resolved the conditions that gave rise to the appearance of the violation. The FDA also issued a safety alert to advise consumers, distributors, and retailers to not eat, sell or serve certain frozen shrimp imported from PT. Bahari Makmur Sejati. 

As a result of the FDA’s ongoing screening efforts, the FDA detected the presence of Cs-137 in one sample of cloves from PT Natural Java Spice. As such, spice products shipped by the firm PT Natural Java Spice to the U.S. have also been added to the import alert for chemical contamination. Products from PT. Bahari Makmur Sejati and from PT Natural Java Spice will not be permitted to enter the U.S. market until these firms provide the FDA with information to adequately demonstrate that they have resolved the conditions that gave rise to the appearance of the violations. 

Effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This represents the first use of this Congressional authority to address ongoing food safety problems while keeping trade flowing for safe products.

Frequently Asked Questions - Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137

A: Import certification is a tool that, when implemented by the FDA, will require certain foreign manufacturers and importers of certain regulated products to obtain and provide certification that product offered for import to the U.S. complies with applicable requirements of the Act. In this instance, import certification will be required starting on October 31, 2025 for:

  • shrimp from the Island of Java and province of Lampung on the Island of Sumatra; and
  • all spices from the Island of Java and province of Lampung on the Island of Sumatra.

The import certification requires that assurances, by a certifying entity designated by FDA, be provided to FDA, stating that products originating from the geographic areas of concern, or harvested, processed, packaged or held in those areas and, intended for the U.S. market,  meet the requirements of the Federal Food Drug and Cosmetic Act (FD&C Act) and are not contaminated with Cesium-137. 

A: The FD&C Act and the Food Safety Modernization Act (FSMA), provides FDA with authority to require certification for certain imported food products to ensure they meet the applicable requirements of the FD&C Act. Import certification is a FSMA tool FDA is implementing to ensure that certain shrimp and spice products coming from specific locations at risk for Cesium-137 contamination within Indonesia are not contaminated with Cesium-137.

FDA can require certification for certain imported foods when applicable statutory factors are met. Here, we have determined known safety risks associated with some foods within a certain region of Indonesia. Accordingly, FDA has deemed it appropriate to require certification for these imported foods that will provide assurance that the food complies with applicable requirements of the FD&C Act prior to firms shipping food products intended for the U.S. market. FDA is using this authority to protect consumers while maintaining robust trade with Indonesia.

A: FDA’s implementation of import certification means that consumers will have access to foods that are safe and in compliance with the Act and not contaminated with Cesium-137.

The FDA continues to collaborate with U.S. Customs and Border Protection and other agencies to investigate Cs-137 contamination in certain products from certain areas of Indonesia to ensure that they do not enter into U.S. commerce.

A: FDA will require import certification and corresponding assurances until such time that FDA determines the risk of Cesium-137 contamination is no longer associated  with products harvested, processed, packed, held, or transported through the geographic region of concern.

Although FDA’s investigation is ongoing, the agency is continuing to collaborate with other U.S. agencies and the Indonesian government to ensure that foods offered for import are safe and that appropriate control measures are implemented to address the contamination.

A: The alerts work together – the firms with confirmed contamination must first be removed from the Red List on IA 99-51 by demonstrating they have resolved the conditions that gave rise to the appearance of the violation (i.e. by investigating to determine the root cause of the contamination, taking corrective actions, etc.). After firms are removed from IA 99-51, then they must obtain certification under IA 99-52 to address the continuing food safety risk associated with producing food from a region with Cs-137 contamination. Facilities in affected regions without specific contamination evidence are subject only to IA 99-52 certification requirements, which maintain market access while providing enhanced safety assurance through pre-shipment testing and certification. Import Certification requires steps be taken prior to importing to the U.S., while Import Alerts are actions taken on shipments arrived at U.S. ports of entry.

Import alerts inform FDA field staff that the agency has enough evidence or other information to allow for Detention Without Physical Examination (DWPE) of products subject to an import alert. These two import alerts address different aspects of the cesium-137 contamination issue using different legal authorities.

  • IA 99-51 uses traditional import alert authority under Section 801(a)(3) to address specific contamination violations of individual firms where products appear adulterated under Section 402(a)(4). This alert detains shipments until firms demonstrate they have addressed the specific problems that caused the contamination through corrective actions, or be subject to being refused entry.
  • Import Alert 99-52 requires submission of import certification related to the control of the identified hazard, Cesium-137, from the designated certifying entity before products can enter the United States.

A: FDA has received significant feedback from government partners and industry stakeholders regarding logistical and business concerns for products in transit that will be arriving in the U.S. after October 31, 2025, due to extended transit times. As a result of that feedback, FDA plans to provide alternative screening procedures for certain 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. This temporary alternative screening procedure will still ensure food safety of U.S. imports but recognizes that some shipments were already in transit within a short period of time after FDA announced import certification.

For importers who can demonstrate that a container was on the water on or before Monday, October 13, 2025, FDA will instead follow alternative import admissibility and screening procedures, even if a container arrives in the U.S. after October 31, 2025—the effective date of FDA's import certification requirements. This maintains FDA's commitment to food safety and regulatory oversight through screening processes while acknowledging the practical and logistical complexities of international shipping.

A: FDA’s authority in section 801(q)(1) of the FD&C Act, requires that assurances are from a designated certifying entity as described in section 801(q)(3). A certifying entity may be an agency or a representative of the government of the country from which the article of food at issue originated or a person or entity accredited pursuant to FDA's Third Party Program (TPP). FDA will designate certifying entities appropriate for the circumstances, taking into consideration the forms of assurances it requires and the capacity of the entity to provide the assurances.

Under the provisions of section 801(q)(4)p, FDA may refuse to accept any certification or assurance if it determines the certification or assurance is not valid or reliable. Designating a certifying entity when import certification is required, minimizes concerns about the validity or reliability of the certification or assurances. FDA may designate more than one certifying entity or type of certifying entity, if appropriate. The agency will specify which certifying entities or types of certifying entities may provide the import certification in a final and public notice.

As part of the agency's implementation of import certification for certain foods from certain regions of Indonesia, the agency has designated the Marine Affairs and Fisheries Quality Assurance Agency (MFQAA) of the Ministry of Marine Affairs and Fisheries (MMAF) of the Republic of Indonesia as a certifying entity (CE) for shrimp (and shrimp products) and Indonesia’s Food and Drug Ministry (BPOM) of the Republic of Indonesia as a certifying entity for spices. As the CE, each agency is responsible for providing assurances that the products covered under import certification are not contaminated with Cesium-137.

A: The certifying entity is responsible for providing a certification or other assurances for purposes of section 801(q) as specified in FDA's Notice Designating certifying entities. In this circumstance, this means that the certifying entity is responsible for providing a mechanism for industry to obtain required screening and sampling of shipments of food covered under import certification prior to products being exported for the U.S. and provide certificates to FDA.

A: Please see information (on shrimp and spices) provided by FDA on this topic.

Frequently Asked Questions - General

At this time, no product that has tested positive or alerted for Cs-137 has entered U.S. commerce. Currently, the FDA has identified that all implicated product is tied to PT. Bahari Makmur Sejati and PT Natural Java Spice, both firms of Indonesia.

The FDA detected Cs-137 in a shipment of imported frozen shrimp from PT. Bahari Makmur Sejati that did not enter U.S. commerce. The level of Cs-137 detected in the detained shipment was approximately 68 Bq/kg, which is below FDA’s Derived Intervention Level for Cs-137 of 1200 Bq/kg. The U.S. Customs & Border Protection (CBP) also alerted the FDA to the detection of Cs-137 in a shipping container at the Los Angeles/Long Beach, CA port. The FDA collected multiple samples for radionuclide analysis, with results confirming the presence of Cs-137 in one sample of cloves at 732.43 Bq/kg. Firms with products that have detectable levels of Cs-137 have been added to Import Alert # 99-51 and their products have been denied entry into the U.S.

Consumers should review the existing FDA safety alert for certain frozen shrimp products to determine if they have any recalled products and should not eat, sell, or serve recalled products. Products listed on the FDA safety alert are being recalled because even though testing to date has not confirmed the presence of contamination in any product in commerce, the product appears to have been prepared, packed, or held under insanitary conditions. The shipment that alerted for Cs-137 did not enter the U.S. market. The FDA will continue to issue advice for consumers as needed. 

The FDA has not detected Cs-137 in any product above the current derived intervention levels for Cs-137 (1200 Bq/kg). However, the level detected in the breaded shrimp sample could represent a potential health concern if individuals are exposed for a long period of time when combined with radiation that exists in the environment and from other sources, such as medical procedures. Avoiding products with such levels of Cs-137 is a measure intended to reduce exposure to low-level radiation that could have adverse health impacts with continued exposure over a long period of time. That is why the FDA is working with distributors and retailers that received product from firms included on Import Alert # 99-51 after the date of first detection, but from shipments that did not alert for Cs-137, to determine a need for recalls.

As of September 18, 2025, the FDA's import alert listing applies to all shrimp products and all spice products from the identified firms at all U.S. ports of entry. The import alert listing will remain until the FDA has confidence that future shipments will comply with the FD&C Act. Additional firms may be added to the Import Alert in response to the FDA’s increased screening for elevated levels of Cs-137 for all products coming from Indonesia. The agency is working with Indonesian regulatory authorities to establish preventive measures.

The FDA was notified by CBP of a shipment of cloves from PT Natural Java Spice that alerted for Cs-137. The FDA, in partnership with CBP, took immediate action to protect consumers. The shipment was detained and prevented from entering the U.S. The FDA tested the shipment of cloves and results confirmed the presence of Cs-137 in one sample. No product that has tested positive or alerted for Cs-137 has entered the U.S. marketplace and the FDA has not received any reports of illnesses. The FDA added PT Natural Java Spice to Import Alert #99-51 to prevent any spice product from this company from coming into the U.S until it is in compliance with the FD&C Act. The FDA is continuing to investigate. 

In addition to working closely with CBP, the FDA deployed a variety of surveillance tools, including import entry reviews and sampling at ports, to identify shipments that may pose a health concern in order to ensure the continued protection of American consumers. The FDA is working with foreign competent authorities in Indonesia (Marine and Fisheries Quality Assurance Agency or MFQAA), under the FDA’s information sharing agreement with MFQAA: Update on Indonesia Regulatory Agency | FDA.

All shipments have been detained under the new import alert, and any future shipments of products from these firms will be subject to detention without physical examination, preventing their entrance to the U.S. These companies will need to provide the FDA with information to adequately demonstrate that they have resolved the conditions that rise to the appearance of the violation so the agency will have confidence that future shipments will be in compliance with the law.

Effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This represents the first use of this Congressional authority to address ongoing food safety problems while keeping trade flowing for safe products.

The FDA is continuing to work with CBP, other federal agencies, and Indonesian authorities on this incident to determine the root source of contamination and prevent future shipments of potentially contaminated product from entering the U.S. market. 

Resources

For questions: 

For questions about the general import process, requirements, or resources:

Human Foods Program, Food and Cosmetic Information Center: 1-888-SAFEFOOD (1-888-723-3366) This is specifically for food safety questions, including those related to imports. 

For concerns or questions related to Office of Inspections and Investigations regulatory activities or processes including inspections, investigations, imports, and emergency response contact the OII Ombudsman for assistance. 

Back to Top