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David A. Kessler, M.D. - National Fisheries Institute

"Seafood Safety: The Next Steps"
David A. Kessler, M.D.
Commissioner of Food and Drugs
National Fisheries Institute Annual Convention
Washington, D.C.
November 4, 1993

Good morning.

I am here today to continue a dialogue.

I am here to tell you where we stand on seafood safety and what the next steps will be.

My own dialogue with you started three years ago, when I first became commissioner, and there were questions being asked about FDA's program of seafood safety and quality. I addressed your board of directors because I wanted the seafood industry to know that FDA was listening and ready to respond. Your products are important to our consumers and economy. I wanted you to know that the days when seafood did not receive the attention it deserved at FDA were over. That under this commissioner, seafood would be an FDA priority.

One year later, in May, 1992, I again spoke to your board of directors here in Washington to reaffirm that commitment.

Today, I pledge to all of you my commitment -- and that of the FDA -- to a federal seafood safety program that is strong, effective and fair. A program that gives American consumers confidence that their seafood is as safe and wholesome as nature and human ingenuity can make it.

I know that many of the criticisms aimed at seafood and the way it is regulated have not always been fair or accurate.

We at FDA have worked hard to correct misperceptions about safety that are contrary to the scientific evidence. But many criticisms have been valid and we have had to recognize that fact.

Consequently, we embark on a course of fundamental improvement. Many of the changes that we have made or are striving to make have been advocated by your organization under the capable leadership of Mr. Lee Weddig. It is to your credit that the seafood industry itself has been a powerful and constructive voice for change.

Together, we have a good base to build on.

Three years ago, FDA's seafood program was under attack. Since then, FDA's seafood inspections have been stepped up. Now the agency's seafood program is stronger, more vital, and respected for its leadership and innovation.

Three years ago, FDA's seafood program was funded $22.5 million a year. Now it receives $44 million annually and all program activities have been strengthened.

Three years ago, FDA's seafood operations had no focal point. Now the agency has the Office of Seafood, directed by Tom Billy, with increased resources at FDA headquarters and in the field.

Three years ago, there was divisiveness and acrimony. Now, thanks in part to the leadership of your organization, the relationship that has evolved between the Office of Seafood and the NFI is a positive one, based on straight talk and mutual respect. There will always exist a tension between regulator and industry, it is inherent in the relationship.

But based on the success of our dialogue, I feel certain that we are ready to take the next step in seafood safety -- with or without legislative intervention.

And that step, advocated for years by NFI, is mandatory Hazard Analysis Critical Control Point, or HACCP.

We all know about HACCP.

It's a concept that has been employed in the low-acid canned food industry for more than twenty years. Quite simply, it is a system of common-sense controls applied to the production of food to prevent or minimize the occurrence of safety hazards.

HACCP includes analyzing and identifying hazards specific to the food product; determining where in a processing operation the hazard should be controlled; instituting controls necessary to avoid the problems or minimize the risk; monitoring these controls; and maintaining careful records to demonstrate to the regulatory authorities that the HACCP program is working.

It sounds like a lot; yet, as some of you have learned, these controls need not be expensive or unduly burdensome.

The philosophical underpinning of HACCP is the view that food producers ought to know and understand the likely hazards that can affect their products -- and build steps into the production process that prevent or minimize their occurrence. HACCP's greatest benefit -- for you and consumers alike --derive from that simple notion.

The system is significant not only because it can safeguard seafood products on their way to the dinner table, but also because it gives you an opportunity to demonstrate that the industry knows what needs to be done, and that it is doing it.

In the past, the public debate about seafood inspection has presumed otherwise. It has therefore linked the perceived safety of seafood to the frequency of government inspections.

Given FDA's limited resources, consumers' expectations could not always be met, and the consequences were felt by both the government and the food industry.

These are realities that your organization has long recognized. Your leadership has repeatedly testified before Congress in favor of a mandatory, HACCP-based inspection program. One important legislative principle adopted by NFI is that inspections should ensure compliance with a HACCP-designed control system. When the legislation was not enacted, you urged FDA to adopt such a system administratively.

In response, over two years ago, I initiated an in-house study to determine the feasibility of compulsory, HACCP-based preventive controls for the seafood industry, under current authority, linked to mandatory inspections. That study concluded that such a system is feasible and that it would offer a significant qualitative improvement over the current situation.

Moreover, we concluded that it can be done under our existing statutory authority.

Now, the time has come to move ahead, and make the program a reality. This mandatory HACCP system will require rulemaking to implement, first as a proposal for public comment, and then as a final rule. I can announce today that the proposal is ready, and undergoing final review before publication. We have based the proposal squarely on the well-known principles of HACCP. FDA's role will be to make sure that your HACCP system is in place and working.

We anticipate that this verification will occur as part of our routine inspections. We know that HACCP works. You have demonstrated that. We hear consistently from NFI and elsewhere that those who have already opted for voluntary HACCP have experienced benefits that are both immediate and tangible.

They include a better control over the operation, better sanitation, better employee awareness of safety and sanitation controls, better employee morale as participants in a HACCP system, and fewer mishaps resulting in less product waste and improved yield.

A mandatory program would accomplish even more. It would give American consumers a renewed sense of confidence that it's safe to buy and eat seafood. It would give your industry the satisfaction of using a control system that's recognized as the last word in seafood safety.

Make no mistake: HACCP -- which has been repeatedly endorsed by the National Academy of Sciences is fast becoming the system of choice throughout the developed world.

The international status of HACCP is an important consideration, because of the growing desire of many nations to harmonize the standards for their most important export and import products.

This tendency runs very strong among the major pharmaceutical producers who have in the last two years joined regulatory agencies in Europe, Japan and on this continent in seeking the same rules for the approval of drugs and biologics.

Last week, I attended the Second International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use. The progress reported to the Conference included nearly a dozen harmonization guidelines either completed or in the works, and another two dozen or so expected to be tackled in the next few years. The prospect of a common registration package that would be acceptable is now a realistic goal.

When it comes to food, nations and blocs of nations such as the European Community increasingly favor HACCP or equivalent systems as a condition of entry into their markets.

FDA favors this approach as well. The agency has initiated a new strategy for international agreements. I have recently bolstered the staff within the Office of the Commissioner to strengthen our efforts in the international arena.

We believe that the time has come to move forward in our dealings with foreign countries, and we are doing it.

As you know, the European Community requires that all seafood entering the community be certified by the exporting country. We are complying with that. Moreover, if the EC holds true to its intentions, the seafood products you will export to them in 1995 must have been subject to a HACCP-type system.

Otherwise, they will undergo expensive end-product testing by the EC that you will have to pay for. We are therefore about to start discussing with the EC the possibility of an agreement under which Europe and the U.S. would accept each other's HACCP- based programs and eliminate the paperwork certification procedure.

In the future, we would like to achieve similar agreements with other countries, fostering the use of HACCP to help control the condition of products in international trade.

A mandatory HACCP program is essential if you are going to keep your exports competitive. But that's only part of the international picture.

Consider the area of imports.

I know that the U. S. regulatory structure for imports continues to be of great concern to many of you, for a variety of reasons.

Over 50 percent of seafood consumed in this country is imported.

FDA can review virtually all paper entries for imports that are filed with the U.S. Customs Service, but can physically examine less than 5 percent of those entries. Traditionally, our ability to reach back to the country of origin through foreign inspections has virtually been nil due to costs and issues relating to sovereignty.

We maximize our effectiveness by targeting FDA's import examinations and by using the agency's automatic detention power.

Yet I doubt that the public is ever going to be satisfied with the import system as it currently operates. And I know that in your view, those products that do get examined sometime face costly delays.

We are currently testing a system that would allow importers to have their samples tested in private laboratories, and thereby obtain results more quickly. This is a six-month pilot program suggested by the NFI and running in the New York port of entry. But in the long run, we believe that a better solution involves international agreements linked to HACCP.

Now, how can we make this all work?

Perhaps you've heard that the Office of Seafood is preparing a significant public outreach program that would accompany FDA's proposal for a mandatory HACCP system. You will hear more about it in the one-on-one sessions with Office of Seafood staff, beginning tomorrow.

What I want to do now is to stress several points that I regard as particularly important. All of them are predicated on the FDA's regulatory proposal that I have already described, and that is yet to appear on the pages of the Federal Register. And I want to make clear that what I am about to say reflects our current thinking that has by no means hardened into fixed concepts. Our minds are open and ready to be changed in the discussions that would follow once the proposal is made.

But I want to make a few points about the contemplated mandatory HACCP program anyway, because they illustrate the seriousness of purpose with which the agency approaches the seafood safety program.

First, I want you to know that the agency recognizes that the mandatory HACCP system will not be established overnight. The implementation should be a thoughtful process. We intend to give you the time you would need to put the system in place.

Second, we would not simply mandate HACCP and then leave you to figure out the rest for yourselves. Any HACCP system should involve a cooperative effort by FDA and industry.

The Office of Seafood is in the process of completing important guidance packages and model plans as part of a major FDA technical assistance that would be launched when the time is right. We want you to succeed, and we would not want your success to involve excessive cost. You should also know that under our current plan, the HACCP part of our initial inspections under the mandatory program would be facilitative rather than regulatory.

Third, the HACCP program we have in mind would not result in regulatory actions based on insignificant paperwork failures or problems with no real public health significance. In our view, a properly working HACCP system should have built-in self- correcting mechanisms that would help every firm to fix its own problems.

Fourth, we have no intention of making HACCP an excuse for FDA to acquire access to all your records. If the system is implemented, we would be interested only in those records relevant to the operation of your critical control points for food safety.

Fifth, the HACCP program we intend to propose will be reasonable. You would be expected to use it only to control likely hazards, and not every hypothetical hazard that could conceivably happen, regardless of how remote.

Sixth, we want to avoid duplicate and conflicting programs and so do you. We are aggressively pursuing a federal/state team approach. We are convinced that HACCP can provide the basis for a better federal/state relationship for seafood.

Seventh, the notice-and-comment process of our prospective HACCP initiative would be very thorough and sensitive. We realize that a HACCP program is a pioneering undertaking, and we do not pretend to know all the answers. We would want you to take full advantage of the opportunity to comment, and we would listen closely to your views.

Eighth, and this applies not just to HACCP, it is not our intent that seafood should be singled out and held to a higher standard than the rest of the food industry.

The same reasons why HACCP should be used in seafood apply to foods generally. You may well lead the way, but you would not be without followers.

We are in the process of gathering the information needed to apply HACCP to other sectors of the food industry. The Department of Agriculture is also working toward the implementation of HACCP for meat and poultry. FDA, the Department of Health and Human Services, and the Department of Agriculture are consulting about ways to ensure that the administration's food safety initiatives will be as uniform as possible.

We believe HACCP is such a powerful safety tool that it should be introduced and applied throughout the food manufacturing chain.

What we're contemplating, therefore, is merely the beginning of a process that in time might embrace the entire national food supply.

Still, you might ask why the process has to be led by seafood.

The simple answer is that we believe that your industry is ready.

Through the leadership of NFI and other seafood associations, HACCP has reached an advanced stage of development. It was the National Fisheries Institute that initiated the model seafood surveillance project, in which over 1000 individuals from the seafood industry participated in developing model HACCP plans for most types of seafood.

NFI was also instrumental in launching in 1991 the study on seafood safety by the National Academy of Sciences that reiterated the NAS' longstanding endorsement of HACCP.

Various other trade associations have conducted HACCP pilot projects for seafood. We, along with the National Oceanographic and Atmospheric Administration, have conducted HACCP pilot projects as well.

There is really nothing left to be done but to get on with the main task, as your organization has recently urged.

Our effort at FDA comes not in response to any food safety crisis. It is rather in fulfillment of our continuing and collective obligation to the American public to ensure that the food supply is as safe as we are capable of making it.

It is also an acknowledgment -- and I have said it before -- that on the whole, our nation has a piecemeal, reactive food safety system that needs to be replaced by a comprehensive whole based on principles of prevention. There is a major task ahead - - and HACCP can help us meet that challenge.

Your organization deserves great credit for recognizing the important advantages of HACCP, and for supporting the system.

Together, we are ready to dramatically strengthen the food safety system in this country. We will continue to work with you in this great endeavor in the years ahead.

Thank you.