U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood Presentation, September 1996

Seafood HACCP Implementation Timeline Presentation

The Seafood HACCP Regulation becomes effective on December 18, 1997. What happens in the meantime?

I'd like to break that time period into three segments:

Phase I

What should the seafood industry be doing?

• Look at your prerequisite programs
  • Sanitation
    • Do you or your employees need training in sanitation or GMP's? -- If so, such training is often available from Sea Grant, Cooperative Extension, Trade Associations, Private Consultants, and State and local health authorities.

    • Does your facility meet the requirements of the Good Manufacturing Practice regulations (21 CFR 110)? -- If not, make the necessary improvements in equipment, facilities, or procedures.

    • Do you have written sanitation procedures (what the regulation calls SSOPs)? -- These are not required by the regulation but are invaluable in meeting its intent. If you don't have them you will benefit from developing them. Again, the intent of the SSOPs should be to meet the standards specified in the GMPs.

    • Do you have an organized system in place to monitor your facility's sanitation conditions and practices? -- If not, you need to develop one. It is not reasonable to expect that the level of sanitation in your facility can be consistently held to a high standard if you do not make a concerted effort to keep an eye on the conditions and practices.

    • Do you have a system in place that ensures that sanitation deficiencies are corrected? - This is critical to making improvements in the overall sanitary condition of your facility. If you don't have such a system in place you should develop one.

    • Do you have a recordkeeping system in place to document your sanitation monitoring and correction efforts? -- If not, you should develop one. This will help you audit your firm's sanitation program, and will ultimately be a required system under the Seafood HACCP regulation.

  • Product Coding
    • Does your firm have a system of product coding? If so, is it suitable for a HACCP program?

    • While there is no regulatory requirement for product coding of seafood products, other than low acid canned foods, coding serves a valuable function in a HACCP program. The period that is covered by a product code will often determine the quantity of product that will need to be subjected to a corrective action when there is a critical limit deviation.

  • Recall Plan
    • Does your firm have a recall plan?

    • While there is no regulatory requirement for a recall plan, such plans also serve a valuable function in a HACCP program. It may be necessary to recall product involved in a critical limit deviation, especially when record review uncovers a problem not detected during monitoring.

What will FDA be doing?

• Working with the Seafood HACCP Alliance to finalize the training materials. (Completed July 1996)
  • Certain HACCP functions must be performed by a trained individual.

  • While there is some flexibility in this requirement, for most of you the easiest way to comply with this requirement will be to have one or more of your employees trained.

  • There are no restrictions on who can deliver the training, but the course must be at least equivalent to a standardized curriculum that is recognized by FDA.

  • To develop such a curriculum, the Seafood HACCP Alliance was formed. It consists of FDA, NMFS, the Association of Food and Drug Officials, which is a professional organization of state and federal food regulators, trade associations, including NFI and NFPA, and academia, especially the Sea Grant program.

  • The primary functions of the Alliance are to develop the standardized curriculum and to set up a system of instructors to deliver the course in a standardized way.

  • Development of the training materials is almost completed, and the Alliance is in the process of recruiting and screening potential trainers.

• Redrafting the guidelines that are intended to help seafood processors with the details of developing appropriate HACCP systems. We call the guidelines the Fish and Fishery Products Hazards and Controls Guide. It is scheduled to be available in June. More on the Guide later in this talk.

Phase II

• Alliance train-the-trainer courses started in July 1996. As I mentioned earlier, the Alliance will be screening potential trainers from those who have expressed an interest to the Association of Food and Drug Officials representative in their area. The Association has five regional affiliates, one for every part of the country, that focus on local issues. The trainers will be selected based on their knowledge of HACCP and their capabilities as an instructor. Additionally, they should be willing to perform training for the Alliance at no cost or on a cost recovery basis, thereby facilitating the Alliance's goal of low cost training for the seafood industry and for seafood regulators. There will be at least two train-the-trainer courses in each of the five AFDO affiliate regions. This should accommodate at least 300 trainers, at no cost to the trainer except their travel expenses.

• Industry and regulator training by Alliance-trained trainers will also begin in July, to be performed by the first wave of trained instructors. Students are to include industry members and State and FDA regulators. Training will be sanctioned by the appropriate AFDO regional affiliate, and certificates will be issued by the AFDO national office. The cost of the courses should be less than $50 -- including approximately $15 for the training materials and $5-10 for certificate processing and registration. Travel and per diem costs are expected to be minimal as plans are to site the courses as close as possible to the industry.

• HACCP training will also be available from other sources, as it has been in the past. For example the National Marine Fisheries Service and the Food Processors Institute of NFPA have been and will continue to offer HACCP courses. Both organizations have committed to reviewing their existing courses and modifying them, as necessary, to ensure consistency with the Alliance course. If need be, past attenders will be updated so that they will not need to be fully retrained.

Phase III: 1997

What should the seafood industry be doing?

• Developing, pilot testing, evaluating, and modifying their HACCP plans.

What will FDA be doing?

• After having attended the Alliance courses in Summer and Fall of 1996, federal and state regulators will be attending training in HACCP auditing skills, probably via satellite down-links, in early 1997. These courses will prepare them for conducting HACCP-based inspections.

• FDA, and possibly states, will start conducting voluntary HACCP reviews at seafood processing facilities. During a routine inspection, if a processor is willing to provide access to his or her HACCP plans and records, the inspector will review the documents and the firm's operations on a nonregulatory basis and provide comments on the extent to which the processor's HACCP program meets the requirements of the regulation. It is likely that the inspector will leave a nonregulatory "report card" that identifies any problems that the inspector noted in the processor's HACCP program. This will give the processor the benefit of input into his or her HACCP plan, and will give the inspector practice at performing HACCP-based inspections.

December 18, 1997 and Beyond

Some commonly asked questions about HACCP implementation

• What happens if FDA determines that my plan is not acceptable?

  The regulation provides that failure to have an adequate plan or to comply with the other requirements of the regulation renders the food adulterated. However, in deciding what if any regulatory action to take when noncompliance is documented, FDA will look at the likelihood that the deficiency could lead to a public health problem. Minor violations that are not likely to affect public health will likely result in verbal or written notification to plant management by the inspector. A range of other regulatory options, including warning letters, seizure, injunction, and prosecution are available for dealing with more serious violations, that have a significant potential to affect the public health.

• Will FDA take the same regulatory action when an inspector encounters a clerical error or some other type of technical error in a HACCP record as when he or she finds that a processor does not have controls in place for a food safety hazard?

  Not likely. There are a number of reviews through which any recommendation for a regulatory action must go -- from the inspector's supervisor through agency legal counsel. At each step the merits of the individual case are reviewed. However, it is safe to say that the agency has neither the interest nor the resource to pursue regulatory action against a processor simply for the existance of clerical-type recordkeeping errors. Having said this, I must explain that the agency does take HACCP records seriously and will be looking to see that they are honestly and consistently completed.

• Will HACCP plans be preapproved by FDA?

  No, it would be impractical for FDA to preapprove HACCP plans, and modifications to HACCP plans. HACCP plans are unique documents that reflect the operation of a single processor. Thus, the adequacy of a plan can really only be determined by going to the plant and matching the plan to the plant. This can best be done during routine in-plant inspections. However, we recognize that the seafood industry needs to know what sort of plan will be acceptable to the agency. We are convinced that the combination of the Hazards and Controls Guide and the Alliance training materials will adequately prepare processors for plan development.

• Will the first inspection of a processor's HACCP plan be regulatory?

  Yes. Because the effective date of the regulation was delayed from one year after publication of the final rule to two years after publication, we believe that processors should be ready for inspection by December 1997. Additionally, if processors make their HACCP plans and programs available to inspectors between now and December 1997, they will be reviewed on a nonregulatory basis, as I explained earlier.

• Will FDA inspectors be evaluating the adequacy of processor HACCP plans or just looking to see that they are being consistently implemented?

  FDA inspectors will be doing both. Many already have significant training in HACCP, and they will be receiving more before the effective date of the regulation. However, it is important to note that an inspector's observations do not represent the final opinion of the agency, and are subject to legal and scientific review. In the case of anticipated regulatory action, final decisions about the adequacy of a HACCP plan will be made by agency experts.

• What is the status of the Hazards and Controls Guide?

  The Guide is intended to be a compilation of the best available information on the subject of hazards and controls in seafood processing. It will contain FDA's recommendations on the hazards that it believes are reasonably likely to occur in specific species and finished product forms under ordinary circumstances. The Guide will not be a binding set of requirements, and processors will be free to select control options that are not included in the Guide as long as they provide an equivalent level of safety assurance. FDA and state regulators will be given training that will enable them to evaluate the adequacy of controls other than those contained in the Guide.

• How will consumers know that HACCP is having any real effect on the safety of seafood?

  Many would expect that the best way to judge the success of HACCP would be to look at the reported illness data. However, because of serious under-reporting and skewed reporting of one type of illness compared to another, reported illness data would not a reliable means of judging program success. FDA has been looking at other ways of judging program success. At present we are considering comparing the level of preventive controls in place for food safety hazards after the effective date of the rule to those in place before that date. We have survey data from a few years back that gives us a good baseline against which to compare. It is likely that future inspections will include the collection of data that facilitates these comparisons.

More About the Guide

• The Seafood HACCP regulation is short as regulations go. It takes up only about five pages in the Federal Register. Essentially, it says processors must operate preventive systems for safety that follow the seven principles and are written down in something we call a HACCP plan. That's pretty general. So to help industry with the details we are developing a guideline in which we will explain what we know about which seafood hazards are associated with which species and products, and how these hazards can be controlled. A fill in the blank HACCP plan will also be included.

• We published a draft of the Guide in 1994 and asked for public comment on it. We received hundreds of comments and are in the process of evaluating them. The next step was the publication of the first edition of the Guide in June 1996. We call it the first edition because we expect the Guide to evolve with changes in the industry and the state of scientific knowledge. We expect to periodically update the Guide over time. As a result it is never too late to comment on its contents. We will consider all comments during the next update.

• The first edition of the Guide will be designed to be a companion document to the Seafood HACCP Alliance training course. The course will provide instruction on the theory and mechanics of how to perform a hazard analysis and develop a HACCP plan and an explanation of the regulation. The Guide will give specific advice on how to control the various food safety hazards associated with seafood. Both will use the same model hazard analysis worksheet and HACCP plan form. Copies of these are included in your information packet.

• Like the draft Guide, the first edition will identify hazards as species-related and process-related. You will be able to look up the species of fish and finished product form of the product of interest and find the potential hazards associated with them.

• The first edition of the Guide will be designed to more explicitly lead the reader through the hazard analysis and HACCP plan development process. The process will be essentially the same as taught in the Alliance course. The Guide will walk you through a series of well defined steps that ultimately lead to a completed HACCP plan. These steps are summarized in a hand-out included in your information packet.

Steps in developing a HACCP plan

• Preliminary steps
  • Describe the food
  • Describe the method of distribution and storage
  • Identify the intended use and consumer
  • Develop a flow diagram

• Hazard analysis worksheet
  • Identify the potential species-related hazards
  • Identify the potential process-related hazards
  • Learn something about the potential hazards
  • Determine which potential hazards are significant
  • Identify the critical control points

• HACCP plan form
  • Set the critical limits
  • Establish monitoring procedures
  • Establish corrective action procedures
  • Establish a recordkeeping procedure
  • Establish verification procedures

Finally, I'd like to close with a few comments on how I believe HACCP presents an opportunity for a fundamental change in the relationship between industry and FDA. Under FDA's traditional food inspection programs there was little incentive for industry to be forthcoming about its problems in discussions with FDA representatives. In fact, many would believe that there has been incentive to keep them concealed. They would argue that if FDA caught wind of a problem, the agency's first reaction would be to document the problem for potential legal action.

HACCP presents quite a different situation. It is true that under HACCP a processor is obliged to document deviations from critical limits. However, just as important is the requirement that processors document their corrective actions. It is this point that shifts the regulatory focus from those occasions when problems occur to those occasions where a processor fails to take corrective action when a problem occurs.

A well intentioned processor who properly develops and implements a HACCP plan but still has occasions where product does not meet the appropriate critical limit need not be concerned about an FDA inspector finding those glitches. That is because the well intentioned processor will recognize that such product represents a potential health hazard and will subject the product to a corrective action that eliminates the hazard or removes the product from commerce. If this is done, the agency has no regulatory interest in the product.

If you don't believe that the agency can behave in this manner, you need only look at the low acid canned food program, in which this has been the course of action for twenty years. By almost all accounts that program has been a complete success, from the prospective of the agency, the industry, and consumers.

In this era of reinvention of government, HACCP offers a real opportunity.