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

Dr. Kessler Speaks at PVNFP Conference
 
 
 
 
ZDBDBDBDBDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDBDBDBDBD?
CDEDEDED4  F D A  P R I M E  C O N N E C T I O N    CDEDEDED4
CDEDEDEDEDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDBDEDEDEDED4
CDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDEDED4
CDEDEDEDEDADADADADADADADADADADADADADADADADADADADADADEDEDEDED4
CDEDEDED4       FISH NET CONFERENCE BULLETINS       CDEDEDED4
@DADADADADDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDADADADADY
FN93-05      DR. KESSLER SPEAKS AT PUBLIC VOICE      03/29/93
               NATIONAL FOOD POLICY CONFERENCE
 
 
 
  ZDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDD?
  3                       Remarks                         3
  3                                                       3
  3                          by                           3
  3                                                       3
  3                David A. Kessler, M.D.                 3
  3                                                       3
  3     Public Voice National Food Policy Conference      3
  3                                                       3
  3                    March 22, 1993                     3
  3                                                       3
  3                   Washington, D.C.                    3
  3                                                       3
  @DDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDY
 
 
Good morning.
 
This is an important conference. It has become a recognized
forum for raising some of the most important policy
questions affecting our food supply.
 
That is testimony to the force and effect of Ellen Haas'
leadership.
 
Today, I am going to keep with the tradition of using this
forum to explore possible new directions in food policy.
 
Recently, I read a survey conducted by the Institute of Food
Technologists which asked various government watchers to
list top federal policy concerns for 1993. The overwhelming
choice for the top federal policy concern of 1993 was food
labelling.
 
Let me disagree.
 
Certainly, food labelling dominated our attention over the
last several years. And while there is still work to be done
to implement the rules, and an enormous educational task
ahead of us to ensure that all Americans can take advantage
of the new label, the policies are largely in place.
 
If I had been asked to respond to the survey, I would have
named food safety as the number one issue that will occupy
federal policymakers over the next several years.
 
Let me tell you why I believe this will be the case.
 
Those who observe the food scene closely would share one
central observation: the way we produce food, distribute it,
and consume it have changed in some very fundamental ways
since the basic elements of today's food safety system were
put in place.
 
If we are going to continue to ensure the safety and
wholesomeness of the U.S. food supply, we can't do our job
the same way we were doing it 25--or even 10--years ago. We
can't afford to march in place.
 
We need to recognize that the food industry has changed
significantly, and that consumption patterns have changed
dramatically.
 
Increasingly, the American consumer is relying on foods
produced in high-tech, centralized processing facilities,
shipped over long distances, and packaged and stored in new
ways. The consumption of prepared foods sold ready-to-eat at
retail outlets is expanding rapidly. And an increasing
amount of the food that we eat originates overseas--over a
million import entries a year and growing.
 
Foodborne illness has always been a public health problem.
But it appears to be on the rise. New pathogens have
appeared.
 
There is more opportunity for food to be contaminated than
in the past because food today is more extensively
processed, handled at more steps between the farm or fishery
and the table, and transported to and from more distant
locations.
 
And contamination by pathogens is not the only problem.
 
We still have to address the ongoing, unsolved problems
associated with the increased use of industrial chemicals,
and the resulting environmental contaminants.
 
In the face of these changes in the production and
consumption of food, consumers ask a very simple and
legitimate question: Is the food supply safe?
 
And any time a problem arises, they also ask me: What are
you doing to make it safe?
 
It's not that the public expects absolute assurances that
food is perfectly safe. But they do expect that a system is
in place to ensure that food is as safe as we can possibly
make it--a system that is responsive to today's realities,
today's risks, and today's consumer expectations.
 
What are the elements of such a system?
 
Certainly, it is no longer enough to think of each
processing plant in isolation, or each step in the
production of food as a self-contained entity.
 
We must think of our food safety system more
comprehensively. We must take the broad view: from farm or
fishery to the dinner table; from the foreign processing
plant to your local retail establishment.
 
This calls for a shift in thinking.
 
Today we have a food safety system that is piecemeal.
 
We examine some modest number of the food entries coming
into this country, but only after they have arrived at our
shores. And we have no authority to inspect foreign plants,
unless we are invited to do so.
 
We inspect domestic food processing facilities, but the
tools we have give us only a snapshot of what is happening
at the facility when our inspectors are present. It is a
snapshot of a single moment in time. It cannot represent
what went on before or what will go on after. And if we are
in a plant only once in so many years, we will never get the
entire picture.
 
The history of food safety regulation is filled with
government watchdogs chasing the horses after they've left
the barn. The current system places too much of the burden
on the taxpayer to find problems.
 
And the FDA's enforcement tools are so rudimentary as to
make that burden overwhelming at times.
 
If there is an adulterated product being shipped, FDA is not
even entitled to the records to tell where that product has
gone. I've faced that situation, myself, and I can tell you
that it becomes extremely difficult to provide consumers
with the assurances they want.
 
Our current system of food safety regulation is reactive.
What we need is a system that is built on PREVENTING
problems in the food supply, and one that gives regulatory
agencies the tools to know that the system is working.
 
Industry needs to have in place basic quality assurance
programs that prevent food safety problems. And the best of
the quality assurance programs build on three decades of
food industry experience with HACCP methodology.
 
They embody some very basic steps: analyze the hazards;
determine where in a processing operation a hazard is likely
to occur; institute the controls needed to avoid the
problem; monitor those controls; and maintain careful
records.
 
Let me emphasize that no new knowledge, no new discoveries,
are needed to meet the new food safety challenges. We can
build on what some companies have been doing for years.
 
The time has come to institutionalize basic preventive
controls to ensure the safety of the food supply. Companies
need to develop and follow state-of-the-art quality
assurance plans, and the government needs to be able to
verify that the plans are being successfully carried out.
 
In some ways it is so simple a concept. But don't let the
simplicity fool you. For a comprehensive food safety system,
based on preventive controls with regulatory oversight,
would represent a major shift in the way the food industry,
regulatory authorities, and consumers approach the task of
safeguarding the U.S. food supply.
 
Such a preventive system could be applied to all segments of
the food industry.
 
Let's talk in some detail about how it could be applied to
one specific area, one important area: seafood.
 
Two years ago, FDA quietly began an in-house study to
determine the feasibility of mandatory preventive controls
for the seafood industry, linked to mandatory inspections.
The approach would be based on the HACCP concept.
 
That study is now virtually complete. It demonstrates that a
mandatory HACCP system for seafood is feasible, and that it
would offer a significant qualitative improvement over the
current system. Moreover, the study indicates that we can
implement such a program under our existing statutory
authority.
 
While the general framework of a system of preventive
controls with federal oversight can be applied across the
board, we must also recognize that specific components of
the food supply have unique elements.
 
Seafood's unique characteristics make preventive controls
especially important.
 
As the National Academy of Sciences has pointed out, most
health risks from seafood come from the environment. Seafood
is still primarily a wild caught product that involves over
350 species from all over the world. Seafood is exposed to
every hazard that can exist in the ocean, including marine
bacteria, toxins, and human pollution. In addition, some
seafood species can form their own toxins if strict
temperature requirements are not adhered to from the moment
they are caught. Seafood is the most perishable of all flesh
foods.
 
In contrast to some other segments of the industry, the
seafood industry is highly decentralized and characterized
by thousands of smaller older businesses and facilities.
There are literally hundreds of vessels that process seafood
on the high seas. It is extremely difficult to reach these
vessels while the processing occurs.
 
One-fifth of the seafood consumed in the United States is
caught by recreational fishermen, and some of this finds its
way into commercial channels. Recreational fishermen cannot
be expected to understand or practice the safeguards we
expect from commercial fishermen.
 
Seafood is consumed raw or partially cooked to an extent
that is unknown for other flesh food. Finally, a majority of the
seafood consumed in this-country is imported--coming from more
than 135 countries, some of which have advanced regulatory
controls, but many of which do not.
 
While the 1991 NAS report concluded that seafood is
basically a safe and wholesome product, the Academy noted
problem areas and ways in which preventive controls can be
strengthened.
 
Illnesses do occur from seafood--and most of them are
preventable. More than 70 people became ill last summer
from scombroid poisoning. In addition, we are finding
natural toxins from the Pacific Northwest that we have not
seen before. There are an unacceptable number of illnesses
and deaths among high risk individuals from Vibrio bacteria.
And we have serious concerns about the high levels of
decomposition we are seeing in some products.
 
For all these reasons, it is imperative that producers
understand the hazards, and demonstrate this understanding
by establishing preventive control systems that the
industry, regulators, and consumers can readily verify.
 
Over the past two years, working with the Department of
Commerce, we have conducted HACCP pilot studies for domestic
seafood processors. The participants generally agree that
this transition to HACCP can generate tremendous benefits
both for them and for consumers. But they also found that
this transition was not easy; it required new ways of
operating and thinking.
 
An FDA survey of high-risk domestic seafood processors
underscored this point.
 
The survey, which we are now completing, points up that the
kind of preventive controls that would enhance consumer
confidence in the final product are not always in place. For
example, some companies had no controls to monitor the adequacy
of their pasteurization process, the integrity of
containers, or the appropriateness of storage temperatures.
 
The survey also documented that cleaning and sanitizing of
processing equipment was not always undertaken at
appropriate intervals.
 
The absence of these controls does not automatically
translate into an unsafe product. Even without these
controls, the product could be fine.
 
The problem is that too many questions remain unanswered.
Too much is left to chance. The likelihood of problems
arising is greater, and it is more difficult to maintain
consumer confidence.
 
Consumers want to know that problems are being prevented
before they can ever occur.
 
The burden of such a preventive system would fall to the
industry. Such a system enables the regulator to take
enforcement action if cooperatively developed quality
assurance measures fail and processors' controls remain
inadequate.
 
But while such a system would place additional
responsibilities on the companies, I believe the industry is
willing to meet that challenge, and step up to the plate.
 
There is strong leadership within the National Fisheries
Institute in Lee Weddig. Leadership that understands what
needs to be done. Leadership that is committed to moving its
membership toward a mandatory HACCP system of preventive
controls. Leadership that has gone on record supporting a
major shift in how seafood safety is regulated.
 
And I believe that as we move forward and shift the
fundamental way that we ensure the safety of other segments
of the U.S. food supply, the leadership of those industries
will be equally supportive.
 
The food processors, led by John Cady, have enormous
scientific expertise that can help set the future direction for
this paradigm shift. And the grocery manufacturers have made it
very clear to me the importance they attach to strong consumer
confidence in the food supply.
 
I want also to tell you, as the Commissioner of Food and
Drugs, how excited we are about working closely with Secretary
Espy, who has already demonstrated his strong interest in
consumer issues.
 
Establishing a preventive control system for seafood, using
our current authority, will serve as the prototype for other
industries.
 
Everyone in this room deserves enormous credit for doing
food labelling right. Now we need to turn our attention to the
next great task: a modern comprehensive system to ensure the
safety of the food supply.
 
 
                                    END