FDA Exercises First Use of Import Certification Authority, Establishing New Requirements to Import Shrimp and Spices from Certain Regions in Indonesia

Effective October 31, 2025, shrimp and spice shipments from the Island of Java and Lampung Province on the Island of Sumatra in Indonesia must meet these new certification requirements. Below we explain FDA’s import certification authority and how FDA is applying these requirements to certain shrimp and spices. This is a developing situation and there are many open questions about the scope, process, and timing for this new requirement.

Statutory Authority for Food Import Certifications

Import certifications are a targeted tool that FDA can use, based on a determination of risk of an imported food, to require industry to demonstrate that the food safety risk has been addressed before a food is imported into the U.S. Section 801(q) of the FFDCA authorizes FDA to require as a condition of admission for import that a “certifying entity” (CE) provide a certification that the food complies with applicable requirements of the FFDCA. When making the determination that a food is required to have an import certification, the agency must base the determination on the risk of the food when considering the following statutory factors:

1. Known safety risks associated with the food,
2. Known food safety risks associated with the country, territory, or region of origin of the food,
3. A finding by the Secretary, supported by scientific, risk-based evidence, that—
   1. the food safety programs, systems, and standards in the country, territory, or region of origin of the food are inadequate to ensure that the article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of the FFDCA; and
   2. the certification would assist the Secretary in determining whether to refuse or admit the article of food under FFDCA section 801(a); and
4. Information submitted to the Secretary in accordance with the process established in section 801(q)(7), which relates to assessing the food safety programs, systems, and standards in a foreign region, country, or territory.

The statute defines CEs as either “an agency or representative of the government of the country from which the article of food at issue originated, as designated by the Secretary” or “other such persons or entities accredited pursuant to [FFDCA] section 808 [(accreditation of third-party auditors)] to provide such certification.” FDA explains on its website that import certifications can take various forms, including shipment-specific certificates, listings of certified facilities, and “other forms as FDA specifies, such as testing records, audit reports, or certificates of analysis.”

New Import Certification Requirements for Certain Shrimp and Spices from Indonesia

On October 3, FDA established an import certification requirement for certain shrimp and spices from Indonesia 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). The Import Alert explains the basis on which FDA made the statutory determination that import certifications are required, stating:

The FDA has made the determination that [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 [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.

FDA intends to implement the import certification requirement starting on October 31, 2025 “for shrimp” and “for all spices” from Island of Java and Province of Lampung on the Island of Sumatra. The certifications required under this Import Alert can only be provided by the designated CE “which must be an agency or representative of the Government of Indonesia, as designated by FDA.” No further details are provided about the content of the required certification or process for obtaining it. FDA also does not specify whether the October 31 starting date applies to the date of export or date of import.

The certification requirements are structured into two categories:

• “Yellow List”: The “Yellow List” identifies foods of a specific origin for which there may be contamination with Cs-137. All shrimp and all spices from Island of Java and Province of Lampung on the Island of Sumatra are currently on the Yellow List. These foods are required to “present a shipment certification” from a designated CE. Shipment-specific certificates may be submitted from a designated CE or designee to FDA directly through the Import Trade Auxiliary Communications System (ITACS) for each entry submission. FDA explains that this ensures the agency can quickly match certificates to specific shipments and verify authenticity with the issuing authority. Food can be detained without physical examination under the Yellow List if it is not accompanied by a certificate from the Indonesian CE. Products detained under Section 801(q) of the FFDCA are not eligible for reconditioning.

The Import Alert also states: “Firms are required to 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.”

• “Red List”: The “Red List” identifies 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-137¹. Food from these firms will not be admitted, even with a certificate from the Indonesian CE.

To be removed from the Red List, these firms are required to have an Accredited Third-Party Certification Program (TPP) certification to verify the control of Cs-137. The 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. The firm also will need to be removed from 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). After removal from the Red List, the Yellow List requirements would then apply.

Next Steps

There are many significant open questions regarding how the import certification requirement will be applied, including:

• Whether the October 31 starting date applies to the date of export or date of import;
• Whether the requirement applies based on the location of the exporting facility, geographic origin of the ingredients, or both;
• Which Indonesian authorities will be designated by FDA as CEs;
• What the Indonesian CE will evaluate in order to issue a certification (e.g., will testing be required?); and
• What will happen if the Indonesian government cannot stand up a program to issue these certifications before October 31.

FDA’s determination that Cs-137 is a known safety risk in certain food from Indonesia also could trigger the need for U.S. importers and manufacturers to reanalyze their hazard analyses as part of their Foreign Supplier Verification Program and Preventive Controls for Human Food obligations.

Hogan Lovells is deeply engaged on this matter and advising companies across the supply chain. Please do not hesitate to contact us if you have questions. We will continue to stay abreast of new developments as this issue evolves.