U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

"Seafood Safety - The Next Steps" - Kessler Speaks to NFI - 11/4/93
 
 
 
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 FN94-02      "Seafood Safety - The Next Steps"      03/08/94
                   - Kessler Speaks to
               National Fisheries Institute
 
 
 
 
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    ]]]                                                       ]]]
    ]]]         "Seafood Safety: The Next Steps"              ]]]
    ]]]                                                       ]]]
    ]]]                       By                              ]]]
    ]]]                                                       ]]]
    ]]]              David A. Kessler, M.D.                   ]]]
    ]]]         Commissioner of Food and Drugs                ]]]
    ]]]                                                       ]]]
    ]]]   National Fisheries Institute Annual Convention      ]]]
    ]]]                Washington, D.C.                       ]]]
    ]]]                                                       ]]]
    ]]]                November 4, 1993                       ]]]
    ]]]                                                       ]]]
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     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.
 
 
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