The agreement demonstrates that processors must comply with hygiene regulations or risk closure. It also shows that the Food and Drug Administration (FDA) is prepared to work with companies to ensure they meet the required standards.
Minneapolis-based Worldwide Fish & Seafood - trading as Coastal Seafood - was facing possible closure after the FDA filed a lawsuit at Minnesota's federal court in November 2006 against the company for violations of the Federal Food, Drug and Cosmetic Act.
However, the company and three of its officers entered into a decree of permanent injunction with the regulator, last week, to comply with hazard analysis and critical control point (HACCP) requirements.
The terms of the agreement include a requirement that the company obtain an expert consultant to evaluate the HACCP plans for all products and the implementation of the plans and submit to an FDA inspection to ensure operations met with regulatory approval.
Worldwide has already received FDA approval of the HACCP plans prepared by its expert and these are currently in use.
The decree allows the FDA to order a shutdown, recall, or other corrective action if future violations occur, and requires the company to pay the costs of all resulting inspections.
Seafood HACCP regulations require processors develop and implement adequate plans that identify all food safety hazards that are likely to occur for each kind of seafood product, and contain preventative measures to control those risks.
Over six years, seven FDA inspections revealed that the defendants' HACCP plans were not adequate to prevent conditions that could pose a potential public health risk.
In particular, the defendants' HACCP violations related to their failure to ensure that their seafood products were transported and continuously stored at adequate refrigeration temperatures to prevent bacteria growth and pathogen development.
In a summary of the filed docket presented to the court in November, the FDA alleged that seven inspections of the company over the past six years revealed it had failed to establish and implement adequate HACCP plans.
Furthermore, the FDA alleged its inspections, including those conducted between November 1 to 3, and on November 6, showed the company failed to ensure its equipment recorded refrigerator temperatures and had not monitored its temperature recording devices.
The FDA said the lack of an appropriate seafood HACCP plan had posed a public health risk, because seafood such as clams, oysters, and smoked salmon can be sources of pathogenic bacteria, including E. coli. Staphylococcus aureus, Listeriamonocytogenes, and Clostridium botulinum.
Worldwide Fish also handles fish species such as tuna, mahi-mahi, and mackerel that when handled inappropriately are known to develop histamine, which can cause severe rash, nausea, vomiting and diarrhea, stated the FDA.
Seafood products, such as those handled by Worldwide Fish, are susceptible to pathogen growth and histamine formation when exposed to abusive conditions, the FDA said.
HACCP is an international standard for food safety procedures in processing plants. The FDA embodied the in law in 1995 and it came into effect in January 1998. HACCP is a science based and systematic method of identifying specific hazards and measures for their control to ensure the safety of food.
The principles are used by processors as a tool to assess safety hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing.
