The U.S. Food and Drug Administration (FDA) has now released detailed data regarding four hundred and eighty-four (484) seafood entry line refusals in September. The vast majority of these refusals related to rejections of shrimp entry lines from an Indonesian exporter, PT. Bahari Makmur Sejati (BMS), following the detection of Cs-137 in some of these shipments. In total, the FDA reported 387 entry line refusals of shrimp exported by PT. Bahari Makmur Sejati (BMS) in September.
Of the remaining ninety-seven (97) seafood entry line refusals in September, eight (8.2%) were for shrimp for reasons related to banned antibiotics. The FDA also released detailed information regarding another entry line of shrimp refused for the presence of veterinary drug residues in August that had not been previously formally reported.
The FDA has now reported refusing a total of sixty-nine (69) entry lines of shrimp for reasons related to veterinary drug residues in 2025. At the end of the first three quarters of the year, the FDA has refused more entry lines of shrimp for banned antibiotics in all but two (2021 & 2024) of the previous eight years.
The nine newly reported entry lines of shrimp refused for veterinary drug residues in August and September were attributed to shipments from four different exporters in China, India, Indonesia, and Malaysia. As noted below, two of the four exporters are Best Aquaculture Practices (BAP)-certified shrimp processors:
- Falcon Marine Exports Ltd. (India), a company that currently operates under four-star BAP certifications for two processing plants (P10015 and P10647) with additional BAP certifications for over 70 shrimp farms and that was added to Import Alert 16-129 (“Detention Without Physical Examination of Seafood Products Due to Nitrofurans”) on April 2, 2025 for the presence of nitrofurans in its shrimp, had one entry line refused for shrimp contaminated with veterinary drug residues by the Division of Northeast Imports on September 11, 2025 and one entry line refused for shrimp contaminated with nitrofurans by the Division of Northeast Imports on September 23, 2025;
- PT. Pabrik Lamongan BMI (Indonesia), a company that currently operates under a four-star BAP certification for its processing plant (P10680) and that was added to Import Alert 16-129 (“Detention Without Physical Examination of Seafood Products Due to Nitrofurans”) on June 12, 2025 for the presence of nitrofurans in its non-breaded shrimp and on June 30, 2025 for the presence of nitrofurans in its breaded shrimp, had one entry line refused for shrimp contaminated with nitrofurans by the Division of Southeast Imports on August 28, 2025, one entry line refused for shrimp contaminated with nitrofurans and veterinary drug residues by the Division of West Coast Imports on September 4, 2025, one entry line refused for shrimp contaminated with nitrofurans and veterinary drug residues by the Division of West Coast Imports on September 16, 2025, one entry line refused for shrimp contaminated with nitrofurans and veterinary drug residues by the Division of Southeast Imports on September 19, 2025, and one entry line refused for shrimp contaminated with nitrofurans and veterinary drug residues by the Division of Northeast Imports on September 24, 2025;
- Fishergold Food Industries Sdn Bhd (Malaysia), a company that is not currently included on the “green” list for Import Alert 16-136 (“Detention Without Physical Examination of Aquacultured Shrimp and Prawn Products in all Market Forms from Peninsular Malaysia Due to the Presence of Unapproved Animal Drugs or Unsafe Food Additives”), had one entry line refused for shrimp cakes/balls contaminated with veterinary drug residues by the Division of Northeast Imports on September 4, 2025; and
- Foshan Runlin Trading Co., Ltd. (China), a company that is not currently included on the “green” list for Import Alert 16-131 (“Detention Without Physical Examination of Aquacultured Shrimp, Dace, and Eel from China and Hong Kong SAR – Presence of New Animal Drugs and/or Unsafe Food Additives”), had one entry line refused for shrimp contaminated with veterinary drug residues by the Division of Northeast Imports on September 24, 2025.
Further, preliminary data released by the FDA through the agency’s Data Dashboard indicates that three additional entry lines of Indonesian shrimp from PT. Pabrik Lamongan BMI were refused on September 29th and 30th by the Division of West Coast Imports for nitrofurans. Confirmation of these entry line refusals will likely be made by the agency next month with the formal release of October refusal data.
Moreover, the FDA’s preliminary data also indicates that another twenty (20) entry lines of Indonesian shrimp from PT. Bahari Makmur Sejati (BMS) were refused by different divisions of the agency on September 30th. Once formally reported, a total of 407 shrimp entry lines from PT. Bahari Makmur Sejati (BMS) will have been refused by the FDA in September.
On Friday, the FDA announced that it was newly issuing 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).” Pursuant to this Import Alert, beginning on October 31, 2025, all shrimp from the island of Java and the province of Lampung on the island of Sumatra in Indonesia will be required to have a shipment certification from a “Certifying Entity (CE),” which must be an agency or representative of the government of Indonesia, in order to be eligible for importation into the United States.
Import Alert 99-52 also creates a pathway through which PT. Bahari Makmur Sejati (BMS) may resume shipments to the United States without going through the removal process specified in 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,” that had been issued in September to authorize the detention, without physical examination, of shipments of shrimp from PT. Bahari Makmur Sejati (BMS). Import Alert 99-51 provided that in order to be removed from the Import Alert, a company would need to provide information to the FDA “to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation.” Now, however, under Import Alert 99-52, PT. Bahari Makmur Sejati (BMS) may resume shipments of shrimp to the United States upon the adoption and implementation of an “Accredited Third-Party Certification Program.” The FDA announced that this represents the first use of authority granted to the agency by Congress through the Food Safety Modernization Act (2011) which created Section 801(q) of Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 381(q)).
It is unclear what practical impact the new certification requirement will have on shipments of Indonesian shrimp to the United States. Several of Indonesia’s large shrimp exporters to the United States are located on the island of Java or in the province of Lampung on the island of Sumatra, including the following BAP-certified shrimp processors: (1) PT. Wintoro Baru; (2) PT. Windublambangan Sejati; (3) PT. Tamron Akuatik Produk Industri; (4) PT. Surya Alam Tunggal; (5) PT. Sekar Katokichi; (6) PT. Sekar Bumi, Tbk; (7) PT. Samudra Seafood Products; (8) PT. Pabrik Lamongan BMI; (9) PT. Khom Foods; (10) PT. Indokom Samudra Persada – Plant (Lampung Province); (11) PT. Grahamakmur Ciptapratama; (12) PT. First Marine Seafoods; (13) PT. Centralpertiwi Bahari Processing Plant 2 (Lampung Province); (14) PT. Bumi Pangan Sejahtera; (15) PT. Bumi Menara Internusa-Dampit Plant; (16) PT Winaros Kawula Bahari; (17) PT Surya Adikumala Abadi; (18) PT Misaja Mitra; (19) PT Indo American Seafoods Tbk. (Lampung Province); (20) PT Bumi Pangan Utama; (21) PT Baramuda Bahari; and (22) Cabang Lampung Bumi Menara Internusa, PT (Lampung Province). These exporters, and all-non-BAP certified shrimp exporters operating in those regions of Indonesia, will, as of October 31, 2025, be required to have an Indonesian government certification accompany their shipments of shrimp to the United States.
This certification requirement responding to the presence of Cs-137 in Indonesian shrimp comes at the same time as the FDA has found an unprecedented amount of banned antibiotics in Indonesian shrimp exports to the United States. Thus far this year, the FDA has formally reported refusing thirteen (13) entry lines of shrimp from Indonesia for the presence of banned veterinary drug residues, with preliminary reporting indicating that a total of sixteen (16) entry lines have been refused. Between 2019 and 2024, a grand total of just two entry lines of Indonesian shrimp were refused for reasons related to banned antibiotics. Based on the refusals formally confirmed by the FDA alone, the agency has already refused more entry lines of Indonesian shrimp for banned antibiotics in 2025 than in any previous year. Nevertheless, the FDA has not taken any additional action to respond to the risk to human health created by what appears to be a significant change in Indonesian shrimp aquaculture.