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

Billy Testifies on Seafood
 
 
 
 
 
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FN93-12           BILLY TESTIFIES ON SEAFOOD         07/07/93
 
 
 
 
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          :                                           :
          :               STATEMENT BY                :
          :              THOMAS J. BILLY              :
          :        DIRECTOR, OFFICE OF SEAFOOD        :
          :                BEFORE THE                 :
          :   SUBCOMMITTEE ON FISHERIES MANAGEMENT    :
          :               JUNE 23, 1993               :
          :                                           :
          HMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM<
 
 
 
Mr. Chairman and  Members of the Subcommittee:
 
 
I am here today at the invitation of the Subcommittee to
describe the current legal and regulatory regime for seafood
safety and the adequacy of that regime for ensuring a reliable
supply of safe seafood products to the American consumer.  It
has been a year since the last Congressional hearing on seafood
safety.  Consequently, this is an appropriate moment to update
the Congress on our activities.  I would like to offer some
background first for the benefit of this subcommittee.
 
I.  BACKGROUND
 
A.  Seafood Presents Special Challenges
 
The Food and Drug Administration (FDA) is one of the primary
Federal regulatory agencies responsible for food safety,
including seafood safety, in the United States.  FDA
administers several acts including the Federal Food, Drug, and
Cosmetic (FD&C) Act, which prohibits adulterated and misbranded
food in interstate commerce.  Although the FD&C Act does not
distinguish seafood from other foods in this regard, we know
from decades of experience that seafood has unique qualities
that require specialized skills and knowledge for us to carry
out our statutory responsibilities.   For example, FDA has
state-of-the-art research facilities dedicated solely to
seafood.  We also have some of the world's leading experts in
marine toxins and other specialties.  Our organoleptic, or
sensory, experts teach other nations how to examine seafood for
signs of spoilage.
 
Ensuring the safety of seafood presents special challenges to
both the industry that produces it and to FDA and other Federal
and State agencies charged with protecting the public health.
Seafood is a disparate array of products encompassing literally
hundreds of edible species that have little in common other
than an aquatic origin.  Collectively, seafood has perhaps the
most diverse and complex microbiology of any food commodity.
The range of habitats for edible species is also extremely
diverse.  These habitats have a bearing on the types of
microorganisms, toxins, parasites, chemicals, and other
potential hazards that fish and shellfish may be exposed to
that can affect human food safety.
 
Seafood is still predominately a wild-caught flesh food that
must be harvested under frequently difficult conditions and at
varying distances -- often quite significant -- from
processing, transport, and retail facilities.  These
conditions, distances, and duration of  fishing trips can tax
any system of controls designed to assure safety and prevent
spoilage.
 
This situation is further complicated by the hazards associated
with the wide array of processes used in several thousand
businesses, many of which are small or old.  The seafood
industry is characterized by small, fragmented operations that
are sized in reference to anticipated benefits and to the
significant, uncontrollable economic risks involved in that
business.  The seasonal nature of the industry can affect
worker skills and practices relating to seafood safety, while
older facilities and equipment can be more difficult to
maintain for adequate sanitation, and proper processing and
storage temperatures.
 
In addition, several hundred vessels are seagoing processing
factories, many of which operate in remote waters.  For
regulators, ships that process at sea can be difficult and
expensive to reach while they are operating, and individual
inspectors face hazards such as ship-to-ship transfers on the
high seas.
 
Seafood can come from a significant recreational harvest, some
of which finds its way into commercial channels.  Thus,
recreational fishing can have a bearing on the safety of
commercial seafood if it occurs in waters that are closed to
fishing or if the catch is mishandled.
 
Yet another complicating factor in ensuring the safety of
seafood is the fact that no other flesh food is imported in the
quantity, variety, or from as many countries, as seafood.
Nearly 60 percent of seafood consumed in this country is
imported from approximately 135 countries.  Several of these
countries have advanced regulatory structures for seafood, but
many others lack comparable structures for seafood sanitation
and safety.
 
B.  The Safety of Seafood:  What We Know
 
There are many hazards that have the potential to affect
safety.  The question of how frequently these hazards occur and
actually cause illness is not currently answerable with
precision because foodborne illness is not always recognized or
properly diagnosed; and because the system for generating and
collecting reports on foodborne illness experiences significant
underreporting.
 
Nonetheless, there are conclusions about the safety of seafood
that we believe can be drawn with confidence because they
reflect general scientific consensus.  The National Academy of
Sciences (NAS) conducted an extensive study of seafood safety
and concluded in its 1991 report that, "Most seafoods available
to the U.S. public are wholesome and unlikely to cause illness
in the consumer."  We agree.  As with many foods, illnesses do
occur, but they are not frequent and, for the most part, they
are not severe.
 
In arriving at its conclusion, the NAS took into account a
number of factors, including the foodborne illness data
reported by State and local health authorities to our sister
agency, the Centers for Disease Control and Prevention (CDC).
In the CDC system, seafood accounted for only 4.8 percent of
reported cases of foodborne illness over the 15 year period
1973-1987.  It should be recognized, however, that, as CDC has
pointed out, comparisons of safety among different foods based
solely on CDC outbreak data are not possible due to variations
in the rates of reporting among different foods and other
factors.  Consequently, this percentage is not definitive with
regard to relative safety and must be considered in terms of
its consistency with other data.
 
While these data have limitations, they can be used to identify
trends and emerging concerns about various diseases.  In
reviewing the CDC data, the NAS noted that the 23 percent
increase in seafood consumption in the U.S. in the 10 year
period ending in 1989 was not accompanied by a concomitant
increase in reported seafood-borne illnesses.  The NAS also
noted that, despite the wide range of hazards that could cause
illness, the data suggest that most seafood-related illnesses
result from molluscan shellfish consumed raw or partially
cooked and from two natural toxins, ciguatoxin and
scombrotoxin, which occur in certain species of finfish.
Ciguatoxin can accumulate in certain warm water reef fish, and
illnesses tend to be geographically localized.  The most
reliable preventive is to avoid fishing in reefs from which
there have been toxic fish.  Scombrotoxin can form when certain
species are not properly cooled after capture.  This
mishandling hazard is completely preventable.  We know that
other seafood hazards do result in illnesses, but the available
data indicate that illnesses from them are not common.
 
FDA conducted a risk assessment for seafood a few years ago in
consultation with CDC.  Using risk assessment methodology,
including reasonable assumptions to fill in the gaps in the CDC
data, we compared the risk of illness from seafood to that for
other flesh foods.  The risk assessment discerned that the
notion promoted by some that seafood poses an
orders-of-magnitude risk above that for other flesh foods is
simply wrong.
 
It is worth pointing out that we must obtain more accurate and
complete data on foodborne diseases in this country than we now
possess if we are to avoid having to rely on questionable
assumptions to fill in the gaps.  New mechanisms to generate
data will be necessary.  "Sentinel surveillance" is one such
mechanism that we have been pilot testing on a collaborative
basis with CDC.  Dr. Paul Blake from the Centers for Disease
Control and Prevention will describe sentinel surveillance in
his testimony today.
 
Neither the CDC data nor the risk assessment take into account
long-term risk from chemical contaminants, so I would like to
address this aspect of seafood safety separately.  There are
simply no available illness data that link commercially
supplied seafood with chronic health effects from chemicals.
Nonetheless, we know that, like other sources of food, fish can
absorb chemicals from the environment, so the question of risk
posed by chemicals is a valid one.  FDA surveillance programs
include monitoring seafood for the presence of chemicals.  We
have more than doubled our sampling program for chemicals in
the past few years.
 
We seldom detect chemical contaminants at levels of concern in
commercial species.  Most problems with chemical contaminants
tend to be localized around known sources of pollution where
commercial fishing is restricted.
 
The NAS similarly concluded that, except in some highly
specific situations, mostly relating to fish originating
outside of commercial channels, there is no evidence of an
urgently critical situation as far as the general population is
concerned.  The NAS also pointed out that there are
uncertainties about the health effects of particular chemicals
and about the extent of contamination.  We generally agree with
the NAS on these points.  As I will discuss later in my
testimony, we recently held a national conference on chemical
contaminants in seafood to pool knowledge with State officials,
scientists, the industry, consumers, and others on chemical
contaminants in seafood.  Statements made at this conference
did not differ from the foregoing conclusions.
 
II.  THE REGULATORY PROGRAM FOR SEAFOOD
 
A.  Overview
 
FDA operates a $40.5 million annual program for seafood.  This
sum reflects an increase of over 60 percent from the $25
million provided by the Congress in fiscal year 1990.  The
essential elements of the seafood program are:  (1) domestic
inspections of seafood processors and related commercial
entities; (2) sampling and analyzing fish and fish products for
the presence of toxins, chemicals, and other potential hazards;
(3) examination of imported seafood offered for entry into the
United States; (4) negotiation of international agreements with
countries that export to the United States; (5) research in
support of the Agency's regulatory mission (for example,
development of methods to detect pathogens, toxins, and
chemical contaminants in fish); (6) Federal/State cooperative
programs, training, and technical support (for example,
administration of the National Shellfish Sanitation Program,
training State retail inspectors and shellfish plant sanitation
inspectors, and training States on how to monitor shellfish
beds for pollution); and (7) public education (for example,
advising certain at-risk populations that they should not
consume raw or only partially cooked molluscan shellfish).  The
Office of Seafood within FDA's Center for Food Safety and
Applied Nutrition manages and establishes policy for this
program.
 
I would like to elaborate on several of these program elements.
 
B.  Domestic Inspection
 
FDA conducts mandatory surveillance inspections of seafood
processors, packers, repackers, and warehouses.  There are
about 5,600 such entities in our seafood establishment
inventory, 2,846 of which are processors.  We regard about
1,000 of these processors to be "high risk" processors because
of the products handled and processing methods used.  For
example cooked, ready-to-eat products require no cooking by the
consumer, and thus must be pathogen free.  FDA targets these
firms for unannounced inspection at least once-a-year, and more
often if problems are found.  All other processors are targeted
for inspection at least every two years and, like high risk
processors, more often if necessary.
 
In addition to our mandatory surveillance program, the National
Marine Fisheries Service (NMFS) operates a voluntary
fee-for-service inspection program for processors and others
who wish to purchase it.  Its program has traditionally been
oriented toward product quality, providing grading and similar
services, but also responds to safety problems consistent with
a memorandum of understanding with FDA.  The two agencies have
worked well together over the years on seafood issues and we
are proud of our relationship with NMFS.
 
States also conduct inspections of seafood processors, so the
overall frequency of inspection -- combining Federal and State
-- is much higher depending on the intensity of State activity.
The State of Alaska, for example, which accounts for half of
domestic seafood tonnage, has a substantial inspection program.
 
We are often asked whether our combined inspection frequency is
adequate to ensure safety.  The question is a valid one, and we
and others have given it considerable thought over the years.
The National Academy of Sciences, in its 1991 study of seafood
safety, concluded that an increase in frequency would have no
bearing on safety, but did advocate that inspections be
conducted on the basis of Hazard Analysis Critical Control
Point, or "HACCP," principles.
 
C.  Domestic Inspection:  HACCP
 
HACCP is a system of preventive controls that are established
and maintained by a processor for the purpose of keeping
hazards from occurring.  As my testimony has already described,
there are a variety of environmental and processing hazards to
which seafood can be exposed from water to table.  It is
imperative that those who handle and process seafood
commercially understand the hazards and keep them from
occurring through a system of routine preventive controls.
 
In essence, HACCP requires that processors have a written plan
that (1) identifies the likely hazards that could affect their
products; (2) identifies "critical control points" where a
failure is likely to cause or permit the hazard to occur; (3)
establishes "critical limits," or measurable operating
parameters at each critical control point, such as cooking and
refrigeration temperatures; and (4) establishes both monitoring
procedures and recordkeeping procedures to systematically
record the results of the monitoring.
 
FDA has consistently advocated HACCP controls for the seafood
industry since the 1980's and, along with the National Oceanic
and Atmospheric Administration (NOAA), has devoted a
considerable amount of attention and resources toward fostering
that goal.  Since the 1970's, FDA has operated the Nation's
first formal, HACCP-based regulatory program, for low-acid
canned foods, many of which are seafoods, and participated with
NOAA in a joint, pilot HACCP program beginning in 1991.  This
pilot program involved working with seafood firms that
volunteered to adopt HACCP-based controls and conducting
inspections to determine how these firms were operating under
HACCP.
 
Two years ago, Commissioner Kessler requested that the Agency
study the feasibility of requiring industry-operated HACCP
systems for seafood coupled with mandatory inspections by FDA
that, among other things, would review the adequacy of those
HACCP systems.  Such a step could be a logical extension and
evolution of our policy and program.  It would also be
responsive to the strong support for the adoption of a
mandatory, HACCP-based inspection system for seafood shown by
consumers, the Congress, and some sectors of the seafood
industry itself.  Based on the results of that study,
Commissioner Kessler announced last March that FDA is
developing mandatory HACCP requirements for the seafood
industry as part of its inspection program.
 
 
The seafood industry  -- indeed, the food industry as a whole
-- must be primarily responsible for the safety and quality of
the food that it produces.  The regulator's primary role should
be to verify that the industry is meeting this responsibility
and to take remedial action when it is not.
 
D.  Import Examination:  Overview
 
Nearly 60 percent of the seafood consumed in the U.S. is
imported.  The number of U.S. Customs entries for seafood is
approaching 200,000 annually.  FDA is committed to ensuring
that imported seafood products meet the same standards that are
required of domestic products.
 
Our import inspection procedure is as follows:  FDA reviews the
entry documents received from Customs for all seafood entries.
The Agency then decides whether to release, visually examine,
or sample a given shipment.  If FDA samples the product and it
is found to be violative, the shipment is detained, and the
importer has the choice of reconditioning the product (that is,
bringing the article into compliance, if this can be done),
destroying it, or reexporting it.  If FDA approves the
importer's proposed reconditioning procedure, the
reconditioning may then proceed under FDA supervision.  If the
reconditioning is successful, FDA may release the goods; if
not, the goods must be reexported or destroyed, under U.S.
Customs supervision.
 
When an imported product is found to be repeatedly violative,
or if it has been found to be a serious health hazard, FDA may
detain all future shipments of that product without sampling (a
policy known as "automatic detention"), until the shipper,
producer, or responsible government agency of the exporting
country produces evidence to FDA's satisfaction that the
shipments conform with the requirements of the FD&C Act.
 
In fiscal year 1992, FDA visually examined over 8,100 carefully
targeted imported seafood entries or "lots," and tested
approximately 7,300 lots for filth, microbiological or chemical
contaminants, heavy metals, pesticides, and parasites.  We also
looked for false labeling that would result in economic fraud.
 
As with domestic products, we have been frequently asked
whether we physically examine enough import entries.  It has
been pointed out that FDA physically examines less than 5
percent of all "lots" of seafood offered for import.  This
figure is generally accurate but is not the whole story.
First, "lots" vary significantly in size and cannot be equated
with poundage or any other unit of measurement.  Also, the
figure does not take into account the representative nature of
the examinations, the targeting of specific lots based on
experience, FDA's automatic detention program for imports, or
the fact that imports receiving further processing in the U.S.
become subject to domestic inspection.  Moreover, five
countries with highly advanced regulatory programs for seafood
-- Canada, Iceland, Norway, Australia and New Zealand --
provide over 30 percent of all imports.  Nonetheless, it is
true that most imported seafood is not physically sampled or
examined by a Federal health official.  Increasing the physical
sampling and analysis of seafood to statistically significant
levels would cost substantial additional public health
resources.
 
E.  Import Examination:  MOUs and HACCP
 
FDA is pursuing two ways of increasing the scope of coverage
for imports.  The first involves the development of memoranda
of understanding (MOUs) with countries that export seafood to
the United States and have recognized inspection programs we
can rely on.  The purpose of a MOU would be to establish that
the regulatory system of an exporting country and the
regulatory system in the U.S. are equivalent in their ability
to ensure safety.  An MOU would provide for regular
verification by both countries.  Products from a MOU country
would not require as much examination by FDA as those from
other countries.
 
The second approach is HACCP.  The HACCP feasibility study
considered requiring that both importers and their foreign
processors operate on the basis of HACCP controls.  While many
importers are conscientious about the safety and quality of the
products they import, others have little understanding of the
potential hazards.  The occasional denial of entry of a
violative lot may be regarded as simply a cost of doing
business.  The burden is on FDA to track down problems and
require corrections.  For the same reasons as provided for
domestic inspections, this burden should shift.
 
We are convinced that a combination of international agreements
and HACCP will provide much greater assurance that potential
hazards are safely being controlled as a matter of design than
the current system can ever provide.  Also, the harmonization
of international approaches to regulating seafood safety
through HACCP has the dual benefit of aiding the U.S. industry
to compete in a global economy and to assure international
cooperation on hazard intervention strategies applied to all
seafoods.
 
F.  Seafood Exports
 
Starting July 1, 1993, and until December 31, 1994, the
European Economic Community (EEC) will require that a "Health
Certificate" accompany each shipment of fish and fish product
entering the EEC.  These certificates show that the "central
authority" of the source country attests that the product was
made in a plant operating under a regulatory regime
("conditions") equivalent to that called for in EEC Directives.
On January 1, 1995, the EEC intends to have a HACCP style
program in place.  After that time other countries will need to
have equivalent manufacturing requirements in order to export
to the EEC.
 
The industry has requested that FDA initiate a program to sign
such export certificates.  The Agency intends to do so.
 
G.  Research
 
FDA has a vigorous research program for seafood in support of
its regulatory mission.  In a field as broad and complex as
seafood safety, there will probably always be problems that
require highly advanced research to solve.  FDA research forms
the basis for the Agency's understanding of the extent and
severity of hazards, for risk assessment, and for risk
management.  Seafood research is carried out at the FDA's
Northeast and Gulf Coast seafood laboratories, at our Seafood
Products Research Center in Washington State, in FDA
headquarters laboratories, and in several of the Agency's 19
field laboratories.  FDA currently has about 100 ongoing
research projects related to hazards posed by microbes,
chemical and drug residues, marine toxins, parasites,
decomposition and new packaging technologies.  Research on
species identification and other areas that may result in
economic fraud, and research into sanitation and filth
contamination is also being conducted.
 
FDA coordinates its research as much as possible with ongoing
research outside the agency.  We work with academia, other
government and private organizations.  In particular, we
maintain an active dialogue with researchers working at the
National Marine Fisheries Service, and facilitate this exchange
through a memorandum of understanding between the two agencies.
 
FDA also funds extramural research.  Perhaps the most notable
ongoing project is a study of the effects of methylmercury on
the fish eating population of the Seychelles Islands.  The
results of that study will help the Agency determine whether
its action level for methylmercury in fish is adequate to
protect the public health.
 
H.  Federal/State Activities
 
The Federal government cannot effectively regulate seafood
without the existence and cooperation of strong State programs.
FDA's HACCP initiative is not intended to -- nor could it
possibly -- alter this reality.  The several roles played by
the States in the regulation of seafood are crucial to the
overall success of the collective Federal/State program.
Together, we estimate that the total outlay by Federal, State,
and local regulatory bodies for the regulation of seafood
exceeds $100 million per year.
 
State roles include the operation of programs for the safety of
molluscan shellfish, inspection of processors, and inspection
of the hundreds of thousands of retail and food service
establishments that are involved with seafood nationwide.  FDA
works with the States by providing funds (although
unfortunately these have decreased recently), participating in
Federal/State cooperative organizations such as the Interstate
Shellfish Sanitation Conference and the Conference for Food
Protection, and by providing technical support, training, and
information.
 
I.  Federal/State Activities:  Molluscan Shellfish
 
One of the keystones of FDA's Federal/State program is the
National Shellfish Sanitation Program (NSSP).  The NSSP is a
Federal/State/industry endeavor, involving 23 shellfish
producing states and 9 foreign governments, that was
established for the purpose of exercising sanitary control over
all aspects of growing, harvesting, shucking, packing, and
interstate transportation of molluscan shellfish.  The
Interstate Shellfish Sanitation Conference (ISSC), an
organization of Federal agencies, State officials, and the
shellfish industry works with FDA to establish the uniform
guidelines and procedures that are used by the shellfish
control agencies of the States that belong to the NSSP.  The
NSSP and the ISSC operate together as a vital adjunct to the
Federal seafood safety program.
 
The National Academy of Sciences has concluded that molluscan
shellfish consumed raw or partially cooked probably cause the
majority of illnesses associated with seafood in the United
States.  This is not surprising because flesh foods consumed
raw are inherently more risky than flesh foods that are
adequately cooked.  In addition, molluscan shellfish are
non-motile filter feeders that pump large quantities of water
through their bodies and can absorb and concentrate many types
of contaminants that may be in the water.
 
The majority of illnesses that are thought to occur from raw
molluscan shellfish are mild gastrointestinal illnesses that
are quickly resolved and are difficult to diagnose.  More
serious illnesses can occur but are uncommon.  Such diseases as
typhoid fever and infectious hepatitis are still commonly
associated with raw molluscan shellfish in lesser developed
countries but are largely controlled in the United States.
 
The key to ensuring that molluscan shellfish do not carry
pollution-borne diseases is the proper classification and
monitoring of shellfish growing waters.  FDA is responsible for
helping design and review the actions States take to classify
their waters.  States are required to take measures to ensure
that illegal harvesting does not occur from closed waters and
to certify that shippers operate in a sanitary manner.  FDA
publishes a monthly shippers list of all certified shippers in
participating States.  To comply with State food service codes,
"receiving" States verify that shellfish come from certified
shippers.
 
The program has its strengths and weaknesses.  FDA's Office of
Seafood recently identified several areas in which the States
could improve their shellfish programs.  This analysis was
based on recommendations of the 1991 National Academy of
Sciences report on seafood safety and a detailed analysis of
the strengths and weaknesses of the procedures in the NSSP
Manual of Operations.  Areas identified in this analysis
included uniform systems for tagging shellfish, effective
prosecution of illegal shellfish harvesters, uniform criteria
for evaluating patrols of growing areas, and consistent product
handling and record retention requirements, as well as specific
temperatures for the holding and transporting of these
products.  These efforts have resulted in the adoption of
beneficial changes by the ISSC, but some areas still require
work.
 
FDA is also concerned that there are inconsistencies in funding
and thus in implementation among the States that ought not to
exist under the program.  We recognize that in the current
fiscal climate there are no ready solutions to this problem.
Nonetheless, funding inconsistencies have the potential to
affect safety and can have the effect of penalizing States that
are devoting the most resources and doing the best jobs.  This
is a problem that remains to be solved.
 
J.  Federal/State Activities:  Training and Other Support
 
Although FDA has statutory authority over all seafood in
interstate commerce, the Agency has traditionally exercised
enforcement discretion with regard to retail establishments.
The sheer number of these establishments would totally
overwhelm any comprehensive Federal inspection system.  FDA has
traditionally provided training and other forms of technical
assistance to States and local governments to inspect retail
food establishments through the Agency's retail Federal/State
cooperative program.  The Agency also has working relationships
with some retailers involving advice and information sharing.
A major part of our retail cooperative program has involved the
development of model codes containing retail handling
requirements for foods, some of which have been widely adopted
by State and local governments.  FDA is now consolidating those
model codes into a single, updated food code for the retail
sector.  HACCP-type controls for seafood hazards at retail are
included.
 
Such controls are needed.  The National Academy of Sciences
concluded in its 1991 study of seafood safety that the greatest
microbiological risk associated with seafood other than raw
molluscan shellfish appears to be mishandling at the retail and
food  service (post processing) levels.  We commend Giant Food
for its participation in the retail pilot HACCP program
operated by FDA and NOAA last year.  That pilot was aimed at
determining the feasibility of adopting HACCP controls within
the retail food sector.
 
K.  Federal/State Activities:  Chemical Contaminants
 
FDA currently has one tolerance, or binding legal limit, for a
seafood contaminant.  That tolerance is for polychlorinated
biphenyls, or "PCB's."  FDA also has "action levels" for
contaminants in seafood that include methyl mercury, paralytic
shellfish poison, histamine in canned tuna, and 13 pesticides.
Action levels are not binding, however, and serve as guidance
only, to ourselves and to States, for deciding when seafood
might be adulterated within the meaning of the FD&C act.
 
We are often asked why we have not issued more tolerances.  The
answer is complex, but in large measure, there are two reasons.
First, as FDA has testified many times, the tolerance setting
process is unwieldy and can take years to accomplish.  Second,
the knowledge required for a tolerance is not easily obtained.
Unlike food additives, chemical contaminants do not have
"sponsors" who submit data to the agency.  The toxicity of many
potential chemical contaminants is not well known.  Finally
consumption data, which are necessary to determine exposure
levels, are expensive to obtain.
 
In addition, problems with contaminants tend to be regional.
FDA has long debated the appropriateness of establishing
national tolerances based on high exposure levels that occur in
very localized areas.
 
FDA sponsored a chemical contaminant conference in May to
address these types of issues.  The participants, many of whom
were State officials from across the country, shared
information on chemical contaminants, exchanged views on
priorities for data collection, discussed regional versus
national solutions, and other matters.  The conference
represents the beginning of a long term process to develop a
Federal/State network for both collecting data and formulating
strategy on chemical contaminants.
 
 FDA is developing "guidance documents" to States on chemical
contaminants.  The first four to be developed relate to
cadmium, nickel, arsenic, and chromium.  Several others are
under development.  The purpose of these documents is to
provide relevant scientific information on each contaminant so
that States and localities can evaluate the public health
significance of contamination of local and regional waters with
those chemicals and determine for themselves when closures or
public health advisories might be appropriate.  We have chosen
this approach for the time being in lieu of establishing a
single, national tolerance for each contaminant that may or may
not be appropriate or useful to deal with regional or local
contamination issues.  Local authorities can utilize the
information in the guidance documents and combine it with local
information on the level of contamination found locally and
local consumption patterns to establish risk management
approaches.  FDA will monitor the success of this approach.
 
L.  Education
 
One conclusion drawn by the NAS was that there is a lack of
understanding of the nature of seafood hazards by the consuming
public and that a vigorous information and education campaign
was needed, particularly for high-risk consumers of raw
molluscan shellfish.  We agree.
 
FDA has a longstanding education program that includes, among
other things, the publication of a consumer oriented magazine,
the development of videos, and the dissemination of information
through the Agency's Office of Consumer Affairs, Office of
Public Affairs, and public affairs specialists in all FDA
districts across the nation.  In addition, FDA's Center for
Food Safety and Applied Nutrition opened a special "Seafood
Hotline" (1-800-FDA- 4010) for consumers who have questions
about hazards, purchasing, storing, handling, labeling,
nutrition, economic fraud and other matters.  The hotline is
automated and accessible 24 hours a day with over 50
prerecorded messages.  Callers who wish to speak with a
specialist may do so between 12:00 - 4:00 pm, EST, Monday
through Friday.
 
We received 14,000 calls in the first 8 months of operation.
Questions about storage, freezing and refrigeration are the
most common.  Other questions involve general seafood safety,
home preparation, and the condition of seafood recently
purchased, among other things.  Based on our experience so far,
we believe that the Hotline is providing consumers with a very
useful service.
 
We are also engaging in a special education campaign aimed at
advising high-risk populations about the risk to them from
consuming molluscan shellfish raw or partially cooked.
Molluscan shellfish can carry within them certain naturally
occurring marine bacteria of the genus Vibrio that can cause
severe illness and even death if they enter the blood stream.
In healthy individuals, Vibrio bacteria generally either cause
no illness or cause gastroenteritis, which is rarely serious.
Immuno-compromised individuals, on the other hand, can contract
septicemia, or blood poisoning, from Vibrio bacteria.
Approximately half of the immuno-compromised individuals who
become septicemic from the most virulent of these bacteria,
Vibrio vulnificus, do not survive.  There have been about 12 to
26 reported cases of septicemia from Vibrio vulnificus
annually, although the number will probably be slightly higher
over the past year.  One-third of these illnesses are usually
from bacterial entry into the body from wounds.  The reported
fatalities have averaged between 5 and 12 annually although,
again, the number for the past 12 months may be slightly
higher.  We estimate that there are about 9 million at-risk
individuals who should not eat raw or undercooked molluscan
shellfish.
 
FDA has published four brochures aimed at specific at-risk
populations and has other ongoing educational efforts including
distribution of information kits to so-called multiplier
organizations, articles in medical journals and community
education programs initiated by our public affairs specialists.
We have provided technical assistance and encouragement to the
ISSC in its adoption of a point-of-purchase information message
for at-risk individuals and are also monitoring the effect of
mandatory labeling adopted by some States.
 
Mr. Chairman, that completes my formal testimony.  I will be
glad to answer any questions you may have.
 
 
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