Food & Beverages | Seafood & Juice (HACCP)
FDA has issued specific processing regulations (good manufacturing practices or GMP regulations) governing seafood products and juices. These regulations, called FDA Hazard Analysis and Critical Control Point (HACCP) regulations, require all seafood and many juice processors to identify the hazards that have the potential of contaminating the product through the stream of raw materials into the processing facility, or through the processing steps themselves which, if such hazards occurred, would render the food products unsafe for consumers. The HACCP regulations require seafood and juice manufacturers to identify, define, and monitor Critical Control Points (CCPs) in their processing steps to minimize, reduce or eliminate these hazards and thereby reduce the safety risks associated with such products. The HACCP regulations apply to domestic and foreign seafood and juice manufacturers alike.
There are specific HACCP regulations that apply to U.S. seafood importers and juice importers. These importer requirements must be met. FDA inspectors will eventually arrive at the importer’s company and verify HACCP compliance and, ordinarily, FDA will request a copy of the foreign food processor’s HACCP plan in English. These HACCP regulations are in addition to FDA’s food facility registration requirements under the Bioterrorism Act, FDA’s FCE and SID requirements for canned food manufacturers, and FDA food labeling requirements.
FDAImports.com, LLC, employs former FDA and USDA officials who have been certified as HACCP inspectors or have acted as FDA inspectors and compliance officers reviewing food HACCP plans for FDA HACCP compliance. In this way, FDAImports.com, LLC can show seafood processors and importers and juice manufacturers and importers The Way Through the requirements of the fields of science, law and regulation that intersect at their processing or importing facilities.
Foreign Seafood or Juice Manufacturers
Under FDA HACCP regulations, seafood processors and juice manufacturers and importers must comply with federal regulations related to HACCP planning and management. “HACCP Plan” refers to documented procedures which ensure food safety by analyzing food processing to discover and mitigate risks associated with biological, chemical, and physical contamination. Compliant HACCP plans include the following basic elements:
- 1: Conduct a hazard analysis;
- 2: Determine the critical control points (CCPs);
- 3: Establish critical limits;
- 4: Establish monitoring procedures;
- 5: Establish corrective actions;
- 6: Establish verification procedures; and
- 7: Establish record-keeping and documentation procedures.
When FDA finds a problem with imported seafood or imported juice, the agency often will ask to see the importer’s and the foreign supplier’s HACCP Plans. If your product is subject to the FDA HACCP regulations, it is important to conduct a hazard analysis of the product and the manufacturing/handling/shipping processes to correctly identify potential hazards. Such potential hazards must be controlled at appropriate points and these controls must be documented.
On many occasions, international suppliers and processors simply borrow HACCP plans from others in the industry. This is a common and dangerous mistake since each HACCP plan must be specifically tailored to particular products and processes within a specific facility. Another common mistake, particularly among multiple food processors, is to over-commit in the HACCP plan and then fail to implement the plan completely. If FDA discovers you fail to implement your own HACCP plan completely, FDA will not consider you to have reached HACCP compliance. Borrowing a template or boilerplate HACCP plan increases the risk that you will over commit and not implement the written HACCP plan.
Under FDA regulations, seafood or juice products manufactured without a valid HACCP plan are adulterated. Merely failing to have a HACCP plan is evidence under the FDA regulations that the seafood or juice was processed under unsanitary conditions. FDA regularly places foreign processors with inadequate (or no) HACCP plans on FDA Import Alert. Thereafter, FDA will automatically detain future shipments from that foreign processor without conducting any physical examination or sampling of the shipment. FDA concludes that the articles from that processor appear to be adulterated due to insanitary conditions at the manufacturing facility, and therefore FDA will not permit the FDA detained articles to be reconditioned or released for U.S. sale. This effectively bans the foreign supplier's product from the U.S. market.
FDAImports.com. LLC routinely assists its clients in conducting hazard analyses and preparing appropriate and adequate seafood HACCP plans. FDAImports.com, LLC has been able to leverage a client’s adherence to FDA HACCP regulations and guidance documents to obtain removal from FDA import alerts or release of FDA detained products.
Domestic HACCP Inspections
FDA regularly inspects domestic seafood and juice manufacturers, processors, packers, storage facilities, and importers to ensure they have implemented the agency's HACCP regulations. FDAImports.com, LLC consultants and affiliated attorneys regularly assist domestic facilities in preparing for FDA or state HACCP inspections.
When FDA detains imported seafood or juice based upon violations detected through sampling and analysis, the agency requires the importer to show that it performed the required “Affirmative Steps” under the FDA HACCP regulations that apply to seafood importers. FDA often asks for this evidence before considering a request to recondition an imported FDA-detained shipment due to certain HACCP-related violations.
FDAImports.com, LLC assists importers and processors with addressing FDA Facility Inspections.