On Monday, April 18th, FDA published a new countrywide import alert (16-136) subjecting all aquaculture shrimp and prawns “from processors from Peninsular Malaysia” to FDA automatic detention (or detention without physical examination), alleging that all such product appears to contain the illegal antibiotics nitrofurans and chloramphenicol. Thus, for all future arriving entries processed by facilities in Peninsular Malaysia, even shipments currently on the water, importers can expect FDA to automatically detain the shrimp. Importers will be required to sample and test the aquaculture shrimp through private laboratory analysis to obtain FDA release into the United States. This process of automatic detention and private laboratory testing will continue until Peninsular Malaysian aquaculture shrimp processors are gradually added onto the import alert green list exempting them from FDA automatic detention.
A countrywide import alert always creates a shock to the importing community. Private laboratories testing imported shrimp could become backlogged because of the increase in testing demands. FDA will also have to review the private laboratory analytical packages, adding to delays.
Initial Questions for Individual Shipments:
Scope of the alert (what does it cover?):
The import alert technically only applies to shrimp and prawns “from processors from Peninsular Malaysia.” The states of Sabah and Sarawak are not included in the import alert. However, we anticipate FDA will automatically detain all aquaculture shrimp from anywhere in Malaysia until the local FDA import offices learn the geographic regions of Malaysia affected by the alert.
More importantly, this import alert is another example of FDA failing to address a problem at its root cause and instead catching an entire industry in its enforcement net. FDA admits in the import alert that nitrofurans and chloramphenicol are used at “hatcheries [and] farms.” However, the import alert covers all shrimp “from processors from Peninsular Malaysia.” Processors in Peninsular Malaysia are not adding nitrofurans and chloramphenicol to aquaculture shrimp. Still, FDA applies its automatic detention authority at the processor stage rather than the aquaculture stage of the product lifecycle.
Sampling Plan (How many? How much?):
FDA is silent on the specific sampling plan for shrimp automatically detained under the import alert, saying only that the sample must be “representative.” At times, FDA has required each size of shrimp in a shipment to be sampled separately.
Other times, we have convinced FDA to permit us to submit one sample across all sizes in the shipment for testing. This question is critical because it can mean the difference between 1 sample or 4 samples – and that difference represents several thousands of dollars in testing.
Initial Questions about Exemptions from the Import Alert:
Clean Entries (How many?):
FDA does not state in the import alert whether the facility must have at least five consecutive tested, clean, and FDA-released shipments to prove in a petition that the processor’s future entries of shrimp will not contain nitrofurans and chloramphenicol. However, we expect FDA to require this, because FDA guidance states it is necessary in the vast majority of cases.
Foreign Processor Inspections (Required or Not?):
Unlike the Chinese country-wide import alert (16-131), in this import alert FDA states it may require an inspection of the Peninsular Malaysian processor and its supplying farms, by either local authorities or FDA, before placing the processor on the green list. However, FDA often says “may” when it means “must.” For instance, FDA even says in the guidance to the district offices in this import alert that they “may detain without physical examination” aquaculture shrimp from Peninsular Malaysia. But we can basically guarantee that this “may” will always result in a detention – which is why we call it an “FDA automatic detention.” So we expect FDA to require a foreign inspection of some kind by someone the Agency trusts. You can also expect FDA to review the processor’s HACCP program when deciding whether to add a firm to the import alert green list.
What Now?
Importers and processors can turn to FDAImports.com for immediate assistance in dealing with aquaculture shrimp shipments automatically detained for any reason – including this import alert covering Peninsular Malaysia. We can also provide HACCP compliance assistance, and other FDA or Customs regulatory issues. Our team has helped dozens and dozens of companies around the world successfully obtain removal or exemption from FDA import alerts. Contact us today.
