FDA Requires HACCP Plan and Training

for U.S. Fish Processors and Importers

World Aquaculture, 28(3): 62-65.  1997


William A. Wurts, State Specialist for Aquaculture

Kentucky State University Cooperative Extension Program

P. O. Box 469, Princeton, KY 42445




The U.S. Food and Drug Administration (FDA) issued seafood regulations in 1995 based on the concept of Hazard Analysis and Critical Control Point (HACCP).  The FDA has allowed a grace period of 2 years for industry compliance.  To continue doing business after December 1997, U.S. seafood processors and importers must have a written HACCP plan on file and an employee certified through FDA approved HACCP training.  The purpose of these regulations is to ensure safe processing and importing of fish and fishery products.  This program arose because of growing public concern about seafood-borne illnesses and seafood safety as well as from industry requests for a practical, cost-effective solution.


To whom do these regulations apply?



Note – Harvesters, transporters, and aquaculture producers can be influenced indirectly through a processor’s product and shipping specifications, as related to their HACCP plans.


The HACCP system is a common-sense approach designed to identify and control food-safety hazards (i.e. harmful microorganisms, or chemical and physical contaminants) and monitor the controls established.  It depends on industry self-regulation through “preventative management” with the oversight of regulatory agencies.  The seafood HACCP concept is based on 7 principles known as the “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products.”


  1. Conduct hazard analysis and identify preventive measures;
  2. Identify critical control points (CCP);
  3. Establish critical limits;
  4. Monitor each CCP;
  5. Establish corrective action to be taken when deviation from a critical limit occurs;
  6. Establish a record-keeping system;
  7. Establish verification procedures.


However, the FDA regulations about establishing a HACCP plan assume that certain conditions have already been met.  The HACCP plan will be in addition to previously existing requirements for current Good Manufacturing Practices (GMPs), compliance with regulations to prevent economic fraud, and the use of Sanitation Standard Operating Procedures (SSOP).  Sanitation Standard Operating Procedures that must be monitored include:


1.      Safety or water (including ice) that comes into contact with food or food contact surfaces;

2.      Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

3.      Prevention of cross-contamination from unsanitary objects to food, food-packaging material, and other food-contact surfaces -- including utensils, gloves and outer garments, and from raw product to cooked product;

4.      Maintenance of hand washing, hand sanitizing, and toilet facilities;

5.      Protection of food, food processing-packaging materials, and food contact surfaces from adulterants (e.g. lubricants, fuel, pesticides, other unsafe compounds, and chemical, physical and biological contaminants);

6.      Proper labeling, storage, and use of toxic compounds;

7.      Control of employee health conditions that could contaminate food, food-packaging materials, and food-contact surfaces;

8.      Exclusion of pests from the food plant.


Enforcement of HACCP and seafood regulations will be the responsibility of the FDA and state regulatory authorities.


A Brief History of HACCP


Pillsbury Company applied the HACCP concept to food in the early 1960s to supply safe food for the U.S. space program.  Pillsbury had decided the techniques they used were inadequate to ensure that contamination would not occur during food production.  They realized extensive testing, after production, would take too long to be practical for the space program.  It was decided that the best way to insure food safety was to prevent hazards/contamination from occurring during the production process.  Since then, Pillsbury’s HACCP system has gained worldwide recognition as a state-of-the-art method for food-safety control.


The first FDA-required HACCP controls were for canned foods (1973) -- to prevent Clostridium botulinum, the cause of botulism.  In 1985, the National Academy of Sciences recommended that the HAACP approach be adopted by all regulatory agencies and that it be mandatory for food processors.  This recommendation led to the formation of a national advisory committee which standardized HAACP principles for both industry and regulatory authorities.  HACCP has been approved by international organizations such as the Codex Alimentarius (a United Nations commission) and the European Union.  It has also been endorsed by several countries which include Canada, Australia, New Zealand, and Japan.


The HACCP system is not risk-free.  However, it was developed to minimize the risks of food-safety hazards.  HACCP offers an advantage over traditional inspection systems.  Traditional methods study the processing practices in use for the day or period inspected, a snapshot technique.  The HACCP approach allows regulators to examine a company’s records about monitoring and corrective actions over a long period of time.


HACCP Training Required by December 1997


An individual trained in the application of seafood HACCP principles must be employed by or affiliated with a U.S. processor or importer.  This individual shall perform several functions:


·        Develop a HACCP plan;

·        Routinely re-evaluate and modify the HACCP plan and hazard analysis;

·        Review HACCP records.


Training must be equivalent to that received in a program recognized and approved by the U.S. FDA.  At present, the standardized curriculum is a 2˝ day course developed by the national “Seafood HACCP Alliance.”  This program is offered through regional affiliates of the Association of Food and Drug Officials (AFDO) using trainers from academic, industry, and regulatory programs throughout the country.  Job experience and/or other training can serve as acceptable qualification if the knowledge gained is equivalent to that obtained through the standardized curriculum.


For related information click on the topics below:



In, Guidelines for producing food-size channel catfish.

World Aquaculture, 23(1): 70-72.


World Aquaculture, 23(3): 40-41.

Southern Regional Aquaculture Center, Publication No. 442.


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