ISSUE 1

The HACCP Regulation in Brief

Who Must Comply?

• All processors engaged in interstate commerce -- companies that pack, process or hold seafood for shipment, including warehouse operations and distributors.
  
• Importers (special provisions).

What is Required?

• Hazard Analysis. A thorough evaluation of each step of the operation as it affects the safety of the product as consumed. Written documentation of Hazard Analysis is not required but is highly recommended.
  
• HACCP Plan (condensed into table format is fine) if indicated by the Hazard Analysis.
  
• HACCP Records at identified Critical Control Points.
  
• Sanitation Records related to (1) water and ice, (2) food contact surfaces, (3) microbial contamination, (4) hand washing and toilet facilities, (5) chemical contamination, (6) toxic compounds, (7) employee health, and (8) pests.
  
• Trained HACCP Individual (importers exempted). This is required for HACCP development, records review and reassessments / audits.
  
• Verification Procedures. Ongoing checks (e.g., instrument calibration, records review), annual audits, and unscheduled reassessments when conditions change or problems persist.

Where Should Processors Begin?

Most processors have some concept of HACCP principles but may not understand how to implement them in a useful, business-friendly way. In the HACCP COUNTDOWN series we will cover each of the principles, using examples to demonstrate actual practice. We start with a discussion of the prerequisites to HACCP.

HACCP Prerequisites

You will learn in the HACCP course that existing regulations related to Good Manufacturing Practices (GMPs) are essential for HACCP to be successful. Regulatory officials often reference Title 21 part 110 of the Code of Federal Regulations when speaking of GMPs. The GMPs outline agency expectations for producing safe and wholesome products with regard to physical facilities, sanitation, pest control, product handling and other areas. HACCP does not replace the GMPs -- both are required.

To make GMPs plant specific, address each of the requirements in a set of written procedures. First, describe each step of the operation, from receipt of raw materials through shipping or warehousing. Expand these steps to include company policies related to purchase specifications, product lot coding, the basis for chosen processing schedules, preventive maintenance, employee training and references to regulations or industry guidelines where applicable. Also describe methods you use to prevent contamination, especially cross-contamination of cooked products with raw materials.

Next, develop written procedures for cleaning and sanitizing the plant and equipment. These procedures should specify cleaning and sanitation methods, cleaning sequence and time schedules, the equipment and chemicals used and chemical concentrations. Include the location and use of sanitizer dips and footbaths and procedures for monitoring sanitizer concentrations. Also address policies related to employee hygiene, such as hand washing, clothing, illness or skin sores. Written plans for pest management, product recalls and customer complaints are also recommended.

A company-specific description of product flow and processing procedures is commonly referred to as Standard Operating Procedures (SOPs). Those which pertain specifically to GMPs are called Sanitation Standard Operating Procedures (SSOPs). They can be combined into one concise document. Request a sample SSOP, FDA GMPs and supporting record keeping forms from the seafood specialist in your state.

GMPs and SSOPs establish the foundation for HACCP. When properly implemented, SSOPs greatly facilitate Hazard Analysis: the first step in HACCP. They help to justify the selection of Critical Control Points under HACCP and may reduce the daily record keeping requirements of your plan.

Prior to HACCP development, have on file any documentation which supports processing procedures used in the plant. For example, a heating step which kills disease-causing bacteria should have a process schedule established by in-plant study if the step is implemented as a point of control or if heating could otherwise affect the safety of the product. Published industry guidelines or standards are often valuable supporting documents, as are microbiological or chemical analyses of products and water. Also, conduct your own audit for GMP compliance and review inspection reports for deficiencies.

Bottom Line

All of this information may seem a bit overwhelming considering that we have yet to discuss the mysteries of HACCP. As you will soon learn, however, the HACCP plan itself is usually very brief and limited in scope. Written SOPs/SSOPs are not required by the FDA regulation but will allow you to substantiate your HACCP plan when questioned during inspection. In addition to HACCP, the regulation requires processors to keep sanitation records. These will be discussed in the next issue of HACCP COUNTDOWN but are important here because maintenance of sanitation records is greatly facilitated by SSOPs and by a general state of GMP compliance.

HACCP Training in the Mid-Atlantic

HACCP Courses in our area (National Seafood HACCP Alliance, certified by the Association of Food and Drug Officials):

For Information and Assistance

For information and assistance on the subject of HACCP, contact the seafood specialist
in your state:

David Green, North Carolina State University, (919) 726-7341
George Flick, Virginia Tech, (540) 231-6965
Tom Rippen, University of Maryland, (410) 651-6636