Import Alert 99-52
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 99-52
Published Date: 11/03/2025
Type: DWPE
Import Alert Name:
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)
Reason for Alert:
NOTE: The revision to this Import Alert dated 10/31/2025 updates the Reason for Alert section by designating Certifying Entities and the Guidance Section by including agency contacts and a revised Product Description. Changes are noted and bracketed by asterisks (***).
***FDA is implementing import certification for certain foods from certain regions of Indonesia. Hereinafter collectively referred to as certain foods and certain regions.***
Starting on October 31, 2025, for shrimp from Island of Java and Province of Lampung on the Island of Sumatra
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 product 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) 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.
Certificates of assurance from an accredited third-party certification body issued under FDA's TPP must be submitted directly to FDA. TPP certifications for Cs-137 controls 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 (defined above) 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 may be submitted from a designated CE or designee to FDA directly. This ensures FDA can quickly match certificates to specific shipments and verify authenticity with the issuing authority.***
***The certifications must be provided by the designated CE, as designated by FDA.***
Firm 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.
FDA reserves the authority to refuse certificates if FDA determines that a certificate is not valid or reliable.
***The Certifying Entities (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 as responsible for providing shipment-specific certification that certain shrimp products are not contaminated with cesium-137 (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 primary point of contact.
- Indonesia's Food and Drug Ministry (BPOM) of the Republic of Indonesia as responsible for providing shipment-specific certification that certain spice products are not contaminated with cesium-137 (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 primary point of contact.***
***For additional information about Certifying Entities see: https://www.fda.gov/food/environmental-contaminants-food/fda-response-imported-foods-potentially-contaminated-cesium-137.***
***FDA is implementing import certification for certain foods from certain regions of Indonesia. Hereinafter collectively referred to as certain foods and certain regions.***
Starting on October 31, 2025, for shrimp from Island of Java and Province of Lampung on the Island of Sumatra
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 product 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) 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.
Certificates of assurance from an accredited third-party certification body issued under FDA's TPP must be submitted directly to FDA. TPP certifications for Cs-137 controls 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 (defined above) 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 may be submitted from a designated CE or designee to FDA directly. This ensures FDA can quickly match certificates to specific shipments and verify authenticity with the issuing authority.***
***The certifications must be provided by the designated CE, as designated by FDA.***
Firm 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.
FDA reserves the authority to refuse certificates if FDA determines that a certificate is not valid or reliable.
***The Certifying Entities (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 as responsible for providing shipment-specific certification that certain shrimp products are not contaminated with cesium-137 (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 primary point of contact.
- Indonesia's Food and Drug Ministry (BPOM) of the Republic of Indonesia as responsible for providing shipment-specific certification that certain spice products are not contaminated with cesium-137 (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 primary point of contact.***
***For additional information about Certifying Entities see: https://www.fda.gov/food/environmental-contaminants-food/fda-response-imported-foods-potentially-contaminated-cesium-137.***
Guidance:
Divisions may detain without physical examination shipments of identified products from firms identified on the Red List. All other shipments of certain food products from certain regions may be detained without physical examination under the Yellow List when the shipment is not accompanied by a certificate from the Indonesian CE.
The evidence to support recommendations for addition to the Red List may be based on radiation detection alerts from CBP, FDA sample analysis confirming the presence of Cs-137 in the food, or other evidence of contamination available to FDA. The evidence to support recommendations for addition to the Red List of this Alert will be evaluated by the Human Foods Program (HFP) on a case-by-case basis. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO).
Firms listed 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", and listed on the Red List of this Import Alert are not eligible for removal from this Red List until they have been removed from Import Alert 99-51.
NOTE: Products detained under Section 801(q) of the Federal Food, Drug, and Cosmetic Act are not eligible for reconditioning as import certification requires comprehensive documentation of manufacturing processes, ingredient sourcing, and control measures that cannot be verified through reconditioning.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Foreign firms listed on the Red List of this Import Alert will be considered for removal from the Red List upon FDA acceptance of a TPP certification appropriately scoped for the products listed on Red List submitted by the accredited third-party certification body in accordance with the requirements in 21 CFR part 1, subpart M.
Questions or issues involving import operations, contact OII, Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov
*** Import certification questions or concerns regarding human food policy, as well as other questions related to cesium-137 that are not directly related to a detained entry, should be addressed to HFP Import Certification-Cesium at hfp-importcertification-cesium@fda.hhs.gov ***
Questions or issues with regard to human food on policy, sample collection recommendations, or any other additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
The evidence to support recommendations for addition to the Red List may be based on radiation detection alerts from CBP, FDA sample analysis confirming the presence of Cs-137 in the food, or other evidence of contamination available to FDA. The evidence to support recommendations for addition to the Red List of this Alert will be evaluated by the Human Foods Program (HFP) on a case-by-case basis. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO).
Firms listed 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", and listed on the Red List of this Import Alert are not eligible for removal from this Red List until they have been removed from Import Alert 99-51.
NOTE: Products detained under Section 801(q) of the Federal Food, Drug, and Cosmetic Act are not eligible for reconditioning as import certification requires comprehensive documentation of manufacturing processes, ingredient sourcing, and control measures that cannot be verified through reconditioning.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Foreign firms listed on the Red List of this Import Alert will be considered for removal from the Red List upon FDA acceptance of a TPP certification appropriately scoped for the products listed on Red List submitted by the accredited third-party certification body in accordance with the requirements in 21 CFR part 1, subpart M.
Questions or issues involving import operations, contact OII, Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov
*** Import certification questions or concerns regarding human food policy, as well as other questions related to cesium-137 that are not directly related to a detained entry, should be addressed to HFP Import Certification-Cesium at hfp-importcertification-cesium@fda.hhs.gov ***
Questions or issues with regard to human food on policy, sample collection recommendations, or any other additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
Product Description:
***Certain shrimp and spice products from the Island of Java and Province of Lampung on the Island of Sumatra ***
Charge:
The article is subject to refusal of admission pursuant to Section 801(a) in that it is subject to, but not compliant with, a requirement established under section 801(q) of the FD&C Act to be accompanied by an import certification that the article meets applicable requirements of the Act. [Import Certification Required, [Section 801(q)]
OASIS CHARGE CODE: 801CERTREQ
OASIS CHARGE CODE: 801CERTREQ
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
INDONESIA
PT Natural Java Spice
Date Published : 10/03/2025
Jl Raya Bumi Maspion I
, Surabaya,
Jawa Timur INDONESIA
25 - - - -- Vegetables/Vegetable Products
Date Published: 10/03/2025
Desc: All Spice Products
Notes: Firm is eligible for a TPP audit upon removal from IA # 99-51
Problems:
CESIUM-137;
28 - - - -- Spices, Flavors And Salts
Date Published: 10/03/2025
Desc: All Spice Products
Notes: Firm is eligible for a TPP audit upon removal from IA # 99-51
Problems:
CESIUM-137;
PT. Bahari Makmur Sejati
Date Published : 10/03/2025
Utama Modern Industri AA 1
, Serang,
Banten INDONESIA
16 - - - -- Fishery/Seafood Products
Date Published: 10/03/2025
Desc: All Shrimp Products
Notes: Firm is eligible for a TPP audit upon removal from IA # 99-51
Problems:
CESIUM-137;