I am starting this blog to discuss the modernization of food safety management in the US, and why it’s important that the seafood industry is proactive about implementing some of the new requirements which food producers will implement under the Food Safety Modernization Act (FSMA). While seafood is exempt from one of the seven rules covered under FSMA (i.e., the Preventive Controls Rule), there are several rules which will apply to the seafood industry including sub-parts A (General Provisions), B (Good Manufacturing Practices), and E (Withdrawal of Qualified Facility Exemption).

Seafood processors are required to update their pre-requisite programs to include updates covered in CFR 117 (e.g., cGMP: allergen cross contact, training updates, competency of supervisory personnel, updating risk assessment for sanitation programs, updates to process controls). FDA now has the statutory authority to institute a recall and charge fees for repeat inspections at seafood processing operations. All facilities must also reregister with the FDA every 2 years.

As many of you know, SQSA is a consulting firm focused on seafood production. When I started teaching the AFDO/SHA Seafood HACCP Segment 2 “Live” and Basic 2.5 day courses, I knew it would complement the other services we offered. With the advent of FSMA and requirement for all food industries to implement risk based food safety control strategies, SQSA is broadening its scope to assist all food manufacturers in interpreting and implementing food safety management systems required through FSMA.

I recently attended a 2.5 day “Preventive Controls for Human Food Lead Instructor Training” hosted by the Food Safety Preventive Controls Alliance (FSPCA). As a result of this training, I am now eligible to provide a course which focuses on the development and application of risk-based preventive controls. The FSPCA provides the standardized curriculum, which has been “recognized” by the FDA. Taking this accredited course is one way to be recognized as a “Preventive Controls Qualified Individual.” During the FSPCA “train-the-trainer” course, I quickly realized that the content and flow of the presentation was remarkably similar to the presentation I have been providing to Seafood HACCP students. The PCQI course organizers had chosen the Association of Food and Drug Officials (AFDO) Seafood HACCP Alliance (SHA) Seafood HACCP curriculum as a template for the PCQI course.

Many of you reading this blog want to know why I am advising that seafood companies take this the PCQI course. The answers are simple, and staring right at you every day:


  1. it’s a fact that the number of seafood items recalled for bacterial pathogens has been increasing. It’s also a fact that we are importing close to 90% of our seafood and less than 2% is inspected by the FDA. The Preventive Controls approach to risk assessment is effective at identifying potential hazards associated with process/production. The seafood industry will benefit from learning about preventive controls for process related hazards from the FDA’s new perspective.
  2. Adopting this updated approach to food safety is a good idea because those same consumer safety officers who will audit your facility have been calibrated to audit food safety management systems from a new perspective.
  3. If at some point the FDA decides that seafood producers are covered under the rule, which is possible, you will be a step ahead of the game. Furthermore, new approaches to supplier control and environmental testing, and written programs are already required by most third party food safety standards (accredited under the Global Food Safety Initiative (GFSI)).


Some food safety practitioners may believe that their experience on the job is sufficient to address training requirements under FSMA. I must warn you that your familiarity with terminology, definitions, risk assessment, and the implementation of regulatory requirements is subjective, and you may be challenged by the officer to justify your experience is equivalent to the PCQI course. This is why receiving PCQI training based on a FDA recognized curriculum is the best way to update your skills and modernize your food safety management system.