In late 2015 the U.S. Department of Agriculture (USDA) issued the final rule for transferring jurisdiction for catfish from FDA to USDA. Given the burden of the new regime, the Final Rule includes an 18-month transitional period. USDA had planned to begin the transition for foreign producers and importers on March 1, 2016. Recently, FSIS published a notice to provide guidelines for inspection and surveillance on domestic fish facilities. While FSIS intends to implement the notice from March 1, FSIS stated in the notice that they would not reinspect or enforce these requirements on imported fish and fish products until April 15, 2016. FSIS extended to a later start date because there would be fish shipments in transit on March 1st. Under FSIS’s reasoning, all the imported fish in transit on March 1st should complete the import process in the USA by April 15, 2016.
Impact of the Transition on Foreign Producers and Importers
Given the burden of USDA’s regulatory regime, the Final Rule includes a multistep transitional process that will take place from March 1, 2016, to September 1, 2017.
- Now until March 1, 2016: Importers can still import without limitation under FDA’s regulatory regime. During this time, the foreign manufacturers’ government agencies need to submit a list of establishments that will export catfish during the transitional period. Each company exporting catfish to the USA, or planning to export, should ensure they are on the local government’s list. We can ensure that U.S. agencies are aware of the manufacturer’s exports as well; contact us through www.exporttoUSA.com.cn for assistance.
- March 1, 2016 to September 1, 2017 (Transitional Period): USDA will begin regulating imported catfish. U.S. importers can continue to distribute any catfish that was imported before March, 1, 2016. Importers can continue to import catfish from foreign manufacturers which were previously included in the list to USDA. During this time, the foreign manufacturers’ government agencies must submit an application to USDA to seek equivalence status.
- September 1, 2017: Unless an application from a foreign government is already submitted and under review, importers can only bring in foreign catfish if USDA has found the foreign government’s regulatory program covering catfish to be equivalent to the USDA/FSIS regulatory programs. It is critical for foreign governments to make application prior to September 1, 2017.
Contrasting FDA’s and USDA’s Approach to Regulating Commodities.
Under FDA’s current regulatory authorities, catfish (including all fish belonging to the Siluriformes order; including swai and basa) is subject to FDA’s sampling, examination, and import alert programs. That will remain until March 1, 2016. FDA does not approve a country or a facility before it can export to the United States; rather, the manufacturer must ensure that it complies with all of FDA’s requirements, including implementing HACCP and ensuring the product is not adulterated or misbranded (improperly labeled). FDA verifies compliance through random inspections of the plant or product.
By contrast, USDA has a stricter regime, which is enforced by its Food Safety and Inspection Service (FSIS). A key difference is that in domestic (USA) processing operations, a USDA official is permanently stationed in the manufacturing facility, continuously inspecting the process to verify compliance. If a USDA inspector is not present, then the facility cannot process the regulated commodities. Once the product is inspected and the label has been approved, the product is officially stamped by USDA as having passed inspection.
FSIS does not station officials overseas. Rather, for foreign-manufactured products, FSIS engages in a three-part process before it will allow product to be imported into the United States. First, a foreign country’s government must formally request that FSIS determine that its inspection system is equivalent to that of the United States. FSIS will first conduct a document review of the country’s laws and administration of those laws, and will then conduct an in-country audit.
If FSIS concludes the foreign country’s system is equivalent, the foreign country’s inspection system then certifies establishments that are permitted to export products to the United States. FSIS maintains a list of these establishments and publishes the list on its website.
Second, each shipment from a certified establishment must be accompanied by an import certificate issued by the foreign country’s inspection authority. This certificate includes several pieces of information such as the product name, establishment number, list of ingredients, and identification marks.
Third, FSIS re-inspects each imported shipment at an approved import facility. During this re-inspection, an FSIS inspector visually inspects the shipment, the certification, and the label for compliance. At this time, the FSIS inspector may conduct a further examination by sampling or testing the shipment to verify compliance. Once the product passes re-inspection, it is stamped with a USDA mark and permitted to enter U.S. domestic commerce.
If the product does not meet U.S. requirements, it is marked “U.S. Refused Entry.” FSIS will refuse a product for numerous reasons, including that the product is from a country or facility that is not eligible to export to the United States, or that it failed an FSIS inspection.
Next Steps
Currently, FSIS’s internal group is working on procedures to implement the rule, according to our recent talk with Agency personnel. Industry can submit questions and concerns to this internal group by emailing askfish@fsis.usda.gov.
Importers and foreign producers can turn to FDAImports.com for guidance during this transition. Our team of regulatory advisors and affiliated attorneys have years of experience helping companies navigate USDA regulations and get their product into the US marketplace. Contact us today.
