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

 
                               TESTIMONY OF DR. MICHAEL FRIEDMAN (MAY
22, 1996)
[U.S. Food
and Drug Administration]
May 22, 1996
 
STATEMENT BY
 
MICHAEL FRIEDMAN, M.D.
 
DEPUTY COMMISSIONER FOR OPERATIONS
 
FOOD AND DRUG ADMINISTRATION
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
BEFORE THE
 
SUBCOMMITTEE ON LIVESTOCK, DAIRY, AND POULTRY
 
COMMITTEE ON AGRICULTURE
 
U.S. HOUSE OF REPRESENTATIVES
 
MAY 22, 1996
 
FOR RELEASE ONLY UPON DELIVERY
 
Mr. Chairman:
 
I appreciate this opportunity to participate in today's hearing on the
inspection of seafood products. I am Dr. Michael Friedman, Deputy
Commissioner
for Operations. I am accompanied today by Mr. Gary Dykstra, Deputy
Associate
Commissioner for Regulatory Affairs, Dr. Fred Shank, Director of the Food
and
Drug Administration's (FDA) Center for Food Safety and Applied Nutrition
(CFSAN), and Mr. Donald Kraemer, the Associate Director of FDA's Office
of
Seafood.
 
It has been nearly 3 years since the Congress held a hearing on the status of
the Federal regulatory program for seafood. At that time, Dr. David Kessler,
Commissioner of Food and Drugs had recently announced that FDA was
working to
enhance its seafood program by adding a mandatory safety system known as
Hazard
Analysis Critical Control Point, (HACCP). The Congress was especially
interested in learning more about it.
 
Today we have a final HACCP rule in place and, along with the seafood
industry,
are entering into an important and challenging period of implementation for
this landmark program. This, then, is an appropriate time to provide this
committee with an update on where the Federal seafood regulatory program is
going, and how HACCP will fit into it.
 
 BACKGROUND
 
 Federal Regulatory Structure
 
The FDA is one of the primary Federal regulatory agencies responsible for
seafood safety in the United States. Other agencies include the National
Oceanic and Atmospheric Administration (NOAA), of the Department of
Commerce,
the Environmental Protection Agency (EPA), and the U.S. Department of
Agriculture (USDA).
 
NOAA operates a trade oriented, voluntary, fee-for-service inspection
program
for seafood processors that utilizes FDA's safety and other standards for
seafood. NOAA also has the authority to close Federal waters to fishing
whenever oil spills, toxic blooms, or other phenomena threaten to impact the
safety of the harvest. FDA and NOAA have worked together under such
circumstances.
 
EPA is responsible for water and air quality that can affect whether edible
fish species are safe to eat. That Agency also establishes tolerances for
residue limits in pesticides. As you know, the USDA is by law, the lead
Federal
Agency for the promotion of aquaculture. The USDA also approves
veterinary
vaccines, including those that may be used in aquaculture species of fish.
 
FDA is responsible for administering several acts, including the Federal Food,
Drug, and Cosmetic (FDC) Act that prohibits adulterated and misbranded
food,
including seafood, in interstate commerce and the Public Health Service Act,
which authorizes measures to prevent the spread of communicable diseases.
Under
the FDC Act, a food is adulterated if it contains any substance that may render
it injurious to health (in other words, if it poses a human health risk), or if
quality defects affect its fitness as food. Food can also be economically
adulterated if it is made to appear to be better than it is or if its labeling
is false or misleading. FDA's seafood program addresses all of these concerns.
 
Your letter of invitation asked us to address seafood inspection. As I will
explain, our regulatory program for seafood is comprehensive and complex
with
inspection being one of many elements that interconnect and support one
another.
 
The Office of Seafood in FDA's Center for Food Safety and Applied Nutrition
has
over 50 specialists who provide direction to the program, coordinate much of
its activities with other agencies, and engage in research in furtherance of
FDA's public health mission. Inspections of commercial seafood processors
are
conducted out of FDA's 21 District offices located around the country.
 
A number of FDA's investigators have spent years developing expertise in the
issues and problems associated with seafood inspection. Most of our
investigators have a bachelor's or advanced degree in a scientific field such
as biology or chemistry when they begin work with the Agency. In addition,
these investigators have been thoroughly trained in relevant topics, such as
food microbiology, food engineering, and epidemiology; training in HACCP
will
begin this summer.
 
FDA has 18 field laboratories that can analyze seafood samples for
contaminants. Many of these analyses involve specialized equipment and skills.
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.
 
 Seafood Poses Special Challenges
 
We know from decades of experience that seafood has unique qualities and
that
specialized skills and knowledge are required to carry out our statutory
responsibilities. 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 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. Seafood is the most
perishable of all flesh foods.
 
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 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 personal physical 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 the fishing is done 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. Over half of the commercial 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.
 
 Seafood Hazards
 
It is worth reviewing the kinds of consumer hazards and problems that can
affect seafood.
 
 Safety Hazards
 
Seafood is subject to a wide range of safety hazards, some of which are
unique
to seafood. Fortunately, most are controllable and occur infrequently,
although
in some cases the controls are not easy and better ones are needed. I will
discuss how we are addressing that problem later in my testimony.
 
In summary, as the National Academy of Sciences concluded in its extensive
1991
study of seafood safety, "Most seafoods available to the U.S. public are
wholesome and unlikely to cause illness to the consumer." We agree. When
consumers sit down to a seafood dinner, they can expect to enjoy a nutritious,
safe meal.
 
That said, I would like to make three additional points about safety. First,
the fact is that illnesses do occur from consuming seafood. We are dedicated
to
understanding why they occur and preventing them.
 
Second, we are convinced that the current level of safety, and the
improvements
we are working towards, derive in large measure from preventive controls as
practiced by the seafood industry and verified by regulatory agencies. When it
comes to safety, we cannot depend on luck.
 
Third, our system of controls must provide confidence to our own consumers
and
to the international community. Increasingly, the acceptability of our seafood
exports in world markets will depend on how our national system of controls
is
perceived by our trading partners. I would like to provide you with a quick
overview of the primary sources of seafood-borne risk to human health.
 
a. Bacteria
 
Other than raw molluscan shellfish, seafood is only rarely a source of illness
caused by bacteria from the environment. Most pathogens are introduced in
the
processing environment. As aquaculture becomes a more important source of
food,
however, care must be taken that bacteria are not carried from contaminated
ponds to workers and consumers.
 
b. Viruses
 
Several viruses infectious to humans enter aquatic habitats through sewage.
Most concentrate in shellfish and can be present and infective even when
bacterial indicators of fecal pollution are absent. Viruses probably cause the
bulk of seafood-associated disease, particularly the Norwalk agent, which is
linked to the consumption of raw or undercooked molluscan shellfish. Viruses
can also be introduced during handling by food plant workers.
 
c. Toxins
 
After Norwalk virus, the two most frequently reported illnesses from seafood
are from toxins. The first is scombroid poisoning, which occurs as a result of
decomposition in certain species of finfish, primarily tuna, mahi-mahi and
bluefish. It is completely preventable through good handling practices.
 
The second is ciguatera poisoning from consuming predatory, tropical and
subtropical fish such as grouper, snapper, barracuda, and Spanish mackerel.
These toxins originate in marine algae and can be concentrated by passage
along
the food chain. Ciguatoxic fish are generally confined to very localized
geographic areas where blooms of the algae occur. The majority of U.S.
ciguatera illnesses are reported from tropic or near tropical areas including
Hawaii, Guam, Puerto Rico, and the Virgin Islands. Many are attributable to
recreational harvest.
 
Other types of blooms, such as those that cause the well-known phenomenon
"red
tide," constitute a public health problem because of their unpredictability and
the rapidity with which toxic concentrations may develop. Blooms occur on
all
coasts of the United States. These toxins can affect shellfish as well as some
finfish. The only available public health measures are surveillance and closure
of harvest areas. Illnesses in the United States essentially involve
recreational harvest from closed areas.
 
d. Parasites
 
Parasites such as the anasakine nematode (round worm) naturally infect many
fish and ocean mammals. When human infections from marine parasites occur
it is
almost always from the consumption of raw fish (sushi, sashimi) or
undercooked
fish. These infections could be completely avoided by adequate cooking or by
commercial freezing if the fish is to be consumed raw.
 
e. Chemical contaminants
 
The presence of toxic chemicals in the aquatic environment leads to the
potential for contamination of fish and shellfish. These chemicals include
pesticides, other industrial chemicals [such as polychlorinated biphenyls
(PCB's)], heavy metals (such as lead, cadmium, and mercury), and petroleum
hydrocarbons.
 
Marine species, especially deep sea varieties, comprise the majority of
commercial fish consumed in this country. Generally speaking, these fish have
little potential to contain chemical contaminants at levels of toxicologic
concern. Fresh water and estuarine species, especially non-migratory bottom
feeders, are generally the most exposed to a variety of chemical contaminants.
Most of the problems with fresh water and estuarine fish have been associated
with waterways known to be generally polluted. Many of these waterways are
presently closed to commercial fishing or harvest, usually through actions by
the States.
 
 Decomposition and Filth
 
Although safety is the Agency's highest priority, the consumer problem that
we
encounter most frequently with seafood is decomposition that affects quality
and fitness, but that does not have an established effect on safety. This
situation derives from the high perishability of seafood that I mentioned
earlier and the sometimes long and difficult route that seafood must take from
water to table. Decomposition is due to poor handling practices somewhere in
the system and is therefore completely preventable.
 
Many of the regulatory actions we take against seafood offered for entry into
the United States as imports are for decomposition, although problems also
occur with domestic products. The traditional method for detecting
decomposition is through sensory analysis. Some chemical "indicator" tests
have
become available, but more are needed. I will discuss decomposition issues
later in my testimony.
 
FDA also takes considerable regulatory action in the area of filth in seafood
products. Like decomposition, most of these actions affect imported products.
 
 Economic Adulteration and Misbranding
 
Seafood has characteristics that lend it to forms of consumer fraud. With the
large number of commercial species, it is not hard to fraudulently represent to
consumers that a cheaper species is a more expensive one, and thus obtain a
higher price. In addition, various forms of seafood can be made to absorb
large
quantities of water that consumers pay for when purchasing on the basis of
weight. Over the decades FDA has developed a comprehensive program for
seafood
to address these and other issues.
 
 THE REGULATORY PROGRAM FOR SEAFOOD
 
 Overview
 
The essential elements of FDA's program have evolved to include the
following:
(1) domestic inspections of seafood processors and related commercial
entities:
(2) sampling and analyzing fish and fishery 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 processing plant inspectors, and
training States on how to monitor shellfish beds for pollution); (7) public
education (for example, advising certain at-risk populations that they should
not consume raw or only partially cooked molluscan shellfish); and (8)
standard
setting for contaminants. I would like to elaborate on several of these program
elements.
 
 Domestic Inspection
 
The FDA conducts mandatory unannounced inspections of various types of
seafood
processors, including packers, repackers, and warehouses. There are about
5,500
entities in FDA's inventory. About 3,800 of these are subject to FDA
inspection; the remainder are processors of raw molluscan shellfish that are
inspected by the States. Of those inspected by FDA, we regard about 1,000 to
be
relatively, "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 essentially pathogen free. "Low
risk"
firms can be relatively simple filleting operations with few potential hazards.
"High risk" firms, historically have been targeted for more frequent inspection
than "low risk" firms.
 
Traditionally, FDA has inspected firms periodically to determine whether they
are complying with FDA's Good Manufacturing Practice regulations for food
which
establish broad principles of sanitation and safety for all types of food
processors. Inspections are also structured to cover such areas as food
labeling, decomposition, and the use of food additives.
 
Inspections can take a few hours to several days, depending on the nature and
complexity of the operation. Inspections tend to focus on equipment and
process, although sensory examination of products also occur. Continuous
inspection of fish has never been regarded as a useful regulatory strategy
because most safety hazards do not lend themselves to sensory examination.
 
As I indicated earlier, in addition to our mandatory surveillance program,
NOAA
operates a voluntary fee-for-service inspection program for processors and
others who wish to purchase this service. NOAA's program has traditionally
been
oriented toward product quality, providing grading and similar services, but it
also responds to safety problems by applying FDA safety standards consistent
with a Memorandum of Understanding with us.
 
States also conduct inspections of seafood processors, so the overall
frequency
of inspection -- combining Federal and State -- is much higher than Federal
inspection alone, 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.
 
 Import Examination: Overview
 
Over 50 percent of the seafood consumed in the United States is imported.
The
number of U.S. Customs entries for seafood is over 200,000 annually. The
FDA is
committed to ensuring that imported seafood products meet the same
standards
that are required of domestic products.
 
The FDA conducts a small amount of overseas inspections, but these are
expensive and will never effectively cover the universe of foreign processors
that ship fish and fishery products to the United States. Consequently, our
primary 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 appears 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 "detention without physical
examination"), 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 FDC Act. When a product is
subject to detention without physical examination, it must be analyzed by a
private laboratory and the results reviewed by FDA before the product may be
admitted into U.S. commerce.
 
In fiscal year 1995, FDA visually examined over 5,935 carefully targeted
imported seafood entries or "lots," and tested approximately 5,523 lots for
filth, microbiological or chemical contaminants, heavy metals, pesticides,
parasites, and labeling that would result in economic fraud.
 
 Research
 
The 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 and targeted
research to solve. The 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 FDA's Gulf Coast
Seafood Laboratory at Dauphin Island, Alabama and the Agency's Seafood
Products
Research Center in Washington State, in FDA headquarters laboratories, and
in
several of the Agency's field laboratories.
 
The FDA currently has research scientists working exclusively on projects
relating to seafood hazards posed by microorganisms, chemical and drug
residues, marine toxins, parasites, decomposition, and new packaging
technologies. Research on species identification and other areas that bear on
economic fraud, and research into the potential health implications of poor
sanitation and filth contamination is also being conducted. In addition, other
researchers are conducting toxicology, microbiology, chemical and pesticide
research that applies broadly to food safety including seafood.
 
The FDA coordinates its research as much as possible with ongoing research
outside the Agency. We work with academia and with other government and
private
organizations. In particular, we maintain an active dialogue with researchers
working at the National Marine Fisheries Service of the Department of
Commerce,
and facilitate this exchange through a Memorandum of Understanding
between the
two agencies.
 
 Federal/State Activities
 
The Federal government cannot effectively regulate seafood without the
existence and cooperation of State programs. The several roles played by the
States in the regulation of seafood are crucial to the overall success of the
Federal/State program.
 
State roles include the operation of programs for the safety of molluscan
shellfish, inspection of seafood processors, and inspection of the hundreds of
thousands of retail and food service establishments that sell or serve seafood
nationwide. FDA works with the States by 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. Some States perform inspections for FDA
through contractual agreement with the Agency. For example, FDA has
contracted
with States for inspection of offshore factory processing ships.
 
 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, several non-producing States, and 9
foreign governments. The organization was established for the purpose of
exercising control over all sanitary 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. The NSSP and the ISSC operate together as a vital
adjunct to the Federal seafood safety program.
 
The key to ensuring that molluscan shellfish do not carry pathogens from
water
pollution is the proper classification and monitoring of shellfish growing
waters. The FDA is responsible for helping to 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. The FDA publishes a monthly
shippers list of all certified shippers in participating States and foreign
countries. To comply with State food service codes, shellfish "receiving"
States verify that shellfish come from certified shippers.
 
 Federal/State Activities: Retail
 
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
levels (post processing). Nonetheless, 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 Federal inspection
system
and would duplicate State and local programs. The 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. FDA's activities in this program also
involve evaluations of State retail food control programs and standardization
of State and local retail food inspectors. 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. A few years ago,
FDA
consolidated those model codes into a single, updated food code for the retail
sector. HACCP-type controls for seafood hazards at retail were included for
the
first time.
 
 Federal/State Activities: Chemical Contaminants
 
In situations where a chemical contaminant is found to occur widely at levels
of public health concern, FDA may establish a limit as a means of assuring the
safety of the food supply. FDA has one tolerance, or binding legal limit, for a
class of seafood contaminants. That tolerance is for PCB's. The FDA also has
"action levels" for contaminants in seafood that include methylmercury,
paralytic shellfish poison, histamine in canned tuna, and six pesticides.
Action levels are not binding, however, and serve as guidance to ourselves
and
to the States when deciding when seafood might be adulterated within the
meaning of the FDC Act. Appropriate public health measures also can be
taken on
the basis of non-binding guidance levels, or when there is no pre-existing
guidance level. For example, in cases of unpredictable contamination, such as
oil spills, the Agency determines whether fish are adulterated under the FDC
Act
on a case-by-case basis and, if so, removes them from commerce.
 
Problems with chemical 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. Consequently, FDA has issued
"guidance documents" to the States on cadmium, nickel, lead, 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 as a single, national tolerance
for each contaminant that may or may not be appropriate or useful to deal
with
regional or local contamination issues.
 
 Education
 
The National Academy of Sciences' study concluded 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.
 
The 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 Offices of Consumer
Affairs and Public Affairs, and through the public affairs specialists in all
FDA districts across the nation. In addition, CFSAN has been operating a
toll-free "Seafood Hotline" (1-800-FDA-4010) since 1992 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 pre-recorded messages. Callers who wish to speak
with
a specialist may do so between 12:00 - 4:00 pm, EST, Monday through
Friday. To
date, the Hotline has received over 87,000 calls.
 
 Integration of the Program within FDA
 
Although the seafood program must maintain its fair share of specialization
and
expertise, it could not effectively function outside of the much larger
framework that FDA provides. Here are some examples.
 
First, as I stated earlier, the seafood program operates primarily under the
authority of the FDC Act, which is the primary food safety law in this country.
The program derives strength from being part of that statutory framework. It
benefits from the many precedents, legal and otherwise, that have developed
over decades for foods generally.
 
Second, the program benefits from its proximity to Agency experts in a
number
of areas.
 
     <*> Agency scientists outside the seafood program constantly provide
their
         expertise and insights to help solve seafood-related problems
         involving chemical contaminants, foodborne pathogens, and toxins.
         These scientists can be located anywhere in FDA, including the
         Agency's National Center for Toxicological Research.
 
     <*> The program benefits from the expertise of HACCP experts who have
been
         involved in HACCP programs and pilots involving other segments of the
         food supply.
 
     <*> It relies on the advice of a Health Hazard Assessment Board within
         CFSAN to help determine the proper response to emerging problems,
such
         as microbial blooms that temporarily cause the presence of toxins in
         commercial fish species that have previously been toxin free.
 
     <*> The Agency's education and outreach experts located in headquarters
         and around the country regularly assist in developing brochures,
         magazine articles, presentations, and other mechanisms to provide the
         public with information on seafood hazards and how to avoid them.
 
Third, the program benefits from the variety of Agency missions and
organizational components.
 
     <*> FDA's seafood inspectors benefit from the perspective and knowledge
         they gain from inspecting other types of foods. For example, they
         regularly apply the expertise that they gain from inspections of
         canned food processors to the inspection of seafood processors that
         prepare cooked, ready-to-eat products or that otherwise use heat as
         part of their process.
 
     <*> FDA's formal liaison with the medical and public health communities
         through its Office of Health Affairs provides information to doctors
         and others. Also, through the efforts of the Office of Health Affairs,
         the computerized print-outs that accompany many prescriptions will
         soon advise certain at-risk individuals about the risk of infection
         from Vibrio vulnificus bacteria in raw oysters.
 
     <*> The Agency's system for receiving and processing consumer
complaints
         for foods generally provides the seafood program with an important
         source of information about potential problem areas.
 
     <*> FDA's well developed structure for Federal/State networking provides
         invaluable liaison assistance to the program.
 
     <*>
     <*> FDA's Center for Veterinary Medicine (CVM) regularly collaborates
with
         the program on matters relating to aquaculture. CVM is responsible for
         approving drugs for use in aquacultured species and developing and
         approving methodologies for the detection of drug residues in
         aquacultured fish.
 
 THE FUTURE OF THE SEAFOOD PROGRAM -- HACCP
 
 Background
 
About 5 years ago, Dr. Kessler ordered the Agency to explore the feasibility
of
mandating HACCP controls for safety throughout the seafood industry. He
had
many reasons for doing so. Let me discuss a few.
 
First, significant segments of the seafood industry were requesting
HACCP-based
inspection requirements. They believed that the continued credibility of their
products in both the domestic and international marketplace required the
existence of a state-of-the-art safety system throughout the industry, and that
there be mandatory inspections for the purpose of verifying the existence of
this system in each processing operation.
 
Second, although the Congress had not enacted seafood inspection legislation
after considering a number of such bills over several years, the common
element
in virtually every bill in both the House and the Senate was a mandatory,
HACCP-based inspection system. The acceptance of this principle was nearly
universal. The FDA had agreed with the Congress on that point and had
testified
repeatedly in favor of a HACCP approach to seafood safety.
 
Third, the National Academy of Sciences, in important studies on food safety
in
1985 and seafood safety in 1991, had advocated the HACCP approach to
food
safety.
 
Fourth, FDA seafood safety program needed to be upgraded to keep up with
the
times, as it was not adequately providing consumers with confidence that
seafood was being adequately regulated.
 
Fifth, a clear trend in the developed world was emerging in favor of HACCP
systems for seafood. It was becoming evident that HACCP would be
necessary to
maintain the U.S. position in world trade.
 
Considerable preparatory work, both inside and outside FDA, made
publication of
the FDA proposed seafood HACCP rule possible in January, 1994. For
example, FDA
and the National Marine Fisheries Service had teamed up to operate a seafood
HACCP pilot project with domestic seafood processors that volunteered to
participate. Seafood trade associations had also operated HACCP pilots with
Federal grant funds. As early as 1986, NMFS had operated a "Model Seafood
Surveillance Project," at the request of the Congress, that studied the
application of HACCP to specific sectors of the seafood industry. This project
conducted 49 workshops involving 1,200 industry, State, and university
participants. Among other things, the results included manuals on how to
apply
HACCP to most segments of the seafood industry.
 
Sea Grant colleges had issued publications on the application of HACCP to
seafood processing. Other nations had already adopted HACCP for seafood or
were
in the process of doing so; Canada had such a system for seafood for a couple
of years. With this rich background of information, FDA was able to develop
a
state-of-the art seafood HACCP program.
 
 What Is HACCP And What Are The Benefits?
 
In summary, HACCP is a system of preventive controls for food safety that
industry operates to keep health hazards from occurring or keep the likelihood
of their occurrence to a minimum. It is not a Government operated system.
The
Government, through its inspections, verifies that industry systems are
adequate and are working, and obtains remedial actions when they are not.
 
HACCP is the mirror image of end-product testing as a means of ensuring
safety.
End-product testing attempts to catch problems after they have occurred. It
has
a hit-or-miss quality that can require the sampling of large amounts of food to
overcome.
 
HACCP can provide a food processor with immediate and relatively
inexpensive
feed-back about whether hazards are being controlled. It is science-based
because it relies on a knowledge of what the reasonably likely food safety
hazards are for a given product and process and what the controls for those
hazards are.
 
As my testimony has already described, there are a variety of food safety
hazards that can affect seafood. It is imperative that those who handle and
process seafood commercially understand those hazards and how to control
them.
 
HACCP does not place any new responsibility onto processors to produce
safe
food. That responsibility already exists. What HACCP does is place the
responsibility on processors to demonstrate -- to themselves and to us -- that
they have correctly identified the hazards and are controlling them as a matter
of design.
 
This, then, is the big change. Traditionally, domestic processors have been
required to allow the FDA inspector into the plant, but after that, the burden
has been on the inspector to find problems. We hope that HACCP will foster
cooperation between our investigators and seafood processors based on
mutual
problem solving relating to the proper establishment and implementation of
HACCP systems.
 
Another big change from our perspective is the recordkeeping aspect of
HACCP.
Under HACCP, processors must identify "critical control points" in their
systems where a failure could cause a hazard to occur. They must then
monitor
those critical control points and record the results. These records should be
of great benefit to the processor in terms of spotting trends and maintaining
control of key processing functions. The records will also enable our
investigators to see the critical safety functions of an operation over time,
not just at the moment of the inspection.
 
For these reasons, we believe that HACCP will provide us with the most
effective and efficient safety system that exists today. We must look to
qualitative, creative improvements to further ensure the safety of seafood.
And, we must constantly examine our program to make sure that it is operated
in
the most effective and efficient way with the resources available to us.
 
 FDA's Final HACCP Rule
 
The seafood HACCP regulations that FDA published last December mandate
preventive controls for safety. While HACCP-type procedures can be applied
to
quality and to economic adulteration, the regulations do not require such
controls for these purposes. FDA's regulatory program for these kinds of
hazards remains the same.
 
The HACCP regulations take up only five pages in the Federal Register. They
are
broadly drafted by design in order to provide seafood processors with the
flexibility to design HACCP systems that fit their own situations. No two
HACCP
systems need be identical.
 
Let me summarize:
 
All commercial seafood in interstate commerce must have been processed
under
HACCP controls. This includes seafood that has been domestically produced
and
seafood that is imported. Foreign processors that export to the United States
must operate under HACCP.
 
Processors must determine whether there are any food safety hazards
associated
with their products that are reasonably likely to occur in the absence of
preventive controls. If there are none, a processor's HACCP responsibilities
have been met. If there is at least one such hazard, the processor must draft a
HACCP plan that describes the processor's HACCP system.
 
The system involves the identification of "critical control points," as I
described earlier. For each critical control point there must be at least one
"critical limit." A critical limit is a value, such as a temperature of a
cooking step that is known to kill pathogens, to which the critical control
point must adhere.
 
Critical control points must be regularly monitored to make sure that they are
not exceeding their critical limits. This monitoring provides the processor
with immediate information about whether its process is in or out of control
from a safety standpoint, and thus provides the processor with a significant
benefit. The results of this monitoring must be recorded and must be available
to inspectors.
 
There are also provisions relating to corrective actions that must be taken
whenever monitoring reveals that a critical control point is exceeding its
critical limit, and to verification steps that processors must take
periodically to ensure that their HACCP systems are still appropriate and are
being operated properly. Training in HACCP principles, or equivalent on the
job
training, is required in order to operate certain aspects of a HACCP system.
 
The regulations require that processors take certain fundamental sanitation
measures throughout their plants (not just at critical control points) as a
prerequisite to HACCP. Unlike beef and poultry, most fish do not naturally
carry human pathogens in their systems. This difference is largely due to the
fact that fish are cold blooded and that most commercial species are from the
open ocean and not subject to human sewage. In most cases, pathogens are
introduced onto seafood as a result of insanitary conditions in a processing or
food handling environment. For this reason, good sanitation is essential.
 
The regulations have special HACCP requirements for raw molluscan shellfish
and
for smoked and smoke-flavored fish to ensure that the special controls
necessary for these products are being implemented.
 
For imports, the regulations require that importers take affirmative steps to
verify that their foreign suppliers are operating in accordance with these
regulations. This is a new regulatory approach for us, and is based on the view
that importers must take some responsibility for the safety of the products
that they choose to import. 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 would shift under HACCP.
 
We have worked hard to tailor the requirements on importers to match the
kinds
of steps that responsible importers already do to ensure that they are
importing a good product. We also have provided importers with flexibility to
tailor their affirmative steps to meet their capabilities and circumstances.
 
Importers need not take any verification steps if they are importing from a
country that has entered into an agreement with the United States that
establishes the equivalency of the regulatory systems of the two countries. In
such a case, the foreign regulatory system provides the verification that
HACCP
is being practiced.
 
All of these provisions become effective on December 18, 1997, 2 years from
the
original date of publication in the Federal Register.
 
 The Fish And Fishery Products Hazards And Controls Guide
 
Because the regulations contain little in the way of detail, we realized
several years ago that processors would benefit from separate guidance on
how
to write a HACCP plan, how to identify hazards and choose appropriate
controls,
and to do the other things necessary to successfully implement a HACCP
system.
 
The FDA issued the guidance to the industry about seafood hazards and
controls
first as a draft for public comment at the same time that we published the
seafood HACCP regulations as a proposal in 1994. We received many
thoughtful
comments from the public on it and we hope to complete the rewrite this
month.
 
The Guide holds the promise of being an extraordinarily valuable tool for the
industry, regulators, and those that teach the application of HACCP to
seafood.
We hope that it will benefit State regulatory agencies as well as FDA
investigators and we are not aware of anything else comparable to it in the
world.
 
The FDA is calling it the first edition of the "Fish and Fishery Products
Hazards and Controls Guide," because of the dynamic nature of the subject.
New
information on hazards is always being obtained and new controls are always
under development. We expect that the Guide will be a perpetual work in
progress and its updating will be an integral part of our program.
 
The process of developing the Guide and thinking through hazards and
controls
in a systematic way has already revealed areas in which more information and
research is needed. There are also areas where controls for known hazards
need
to be improved or simply made more manageable. One example is in the area
of
aquaculture. Aquaculture farms can be subject to pesticide and chemical
run-off
from adjacent land, depending on how that land is being used. Where this
occurs, the processor who purchases fish from the aquaculture farm must
make
sure that the fish do not contain pesticides and other residues in excess of
FDA action levels for pesticides. Whether this responsibility can be met
without expensive testing of incoming raw materials becomes an important
question. While there is probably no single correct answer to this question, we
have decided to encourage States to include the likelihood of chemical run-off
as one criterion in their licensure of aquaculture farms.
 
Processors will be free to use the Guide as they see fit. They will be free to
develop equivalent controls if they do not choose to follow the Guide exactly.
We do not want the Guide to be a substitute for understanding or independent
thought. The Guide will certainly provide processors with important insight
into our thinking and how we are likely to react to their HACCP systems.
 
 HACCP Training
 
One highly welcome consequence of our regulations has been the creation of a
"Seafood HACCP Alliance," consisting of Federal agencies, State regulatory
officials, academia, and industry trade associations. This group formed for the
purpose of developing a uniform core curriculum for seafood HACCP training
for
both industry and regulators and developing a cadre of trainers to deliver this
course.
 
The result is a low cost, 3-day course that will be taught around the country.
Members of industry and regulators will take it side-by-side. The teaching
tools will be the core curriculum developed by the Alliance and the Hazards
and
Controls Guide developed by FDA. On the third day, the students will work
together to develop HACCP plans that we hope can be quickly tailored to the
individual operations of the industry participants.
 
As with the Hazards and Controls Guide, this training should be invaluable to
processors even if there were no mandatory HACCP program. It will teach
important principles of safety and, for many people, a new way of thinking and
operating.
 
Training is scheduled to begin nationwide this summer. The first to be trained
will be about 300 individuals who have applied to be HACCP trainers.
Immediately thereafter, training will begin for everyone who wants it. All FDA
investigators who inspect seafood establishments will take this training plus
an additional course on how to audit a processor's HACCP system.
 
We expect that State investigators will take both courses as well. The
willingness of State regulators to do so is demonstrated by the active
participation of the Association of Food and Drug Officials throughout the
Alliance effort.
 
 Initial Implementation Issues
 
The initial period of implementation will be especially challenging for both
FDA and the industry, because this will be the time when most processors will
develop HACCP plans for the first time and, similarly, FDA will review them
for
the first time. We anticipate a certain amount of trial and error on both sides
during this time and believe that, so long as people are working in good faith,
this will be a process involving mutual cooperation and learning. We have
heard
from many in the industry that they would welcome more joint problem
solving
with FDA, rather than the Agency simply pointing out problems for the
industry
to solve. The implementation of HACCP may facilitate such a transition.
 
The initial review of HACCP plans will be done on site by FDA investigators
as
part of the normal inspection process. Such a review will be made possible by
existing and planned training for our investigators that will make them
competent to make the kind of judgements that reviewing a HACCP plan
requires.
 
We cannot pre-approve HACCP plans, primarily because the appropriateness
of a
plan can only be determined by matching it against the actual conditions and
configuration of the processing operation.
 
Nonetheless, as I indicated earlier, processors will be able to have a good
idea of how FDA will react to their plans from the advice in the Hazards and
Controls Guide and from the Alliance-based training course. In addition,
processors that develop HACCP plans in advance of the effective date will be
able to obtain a non-regulatory "report card" on their HACCP system from
FDA
investigators during inspections that occur during the 2-year grace period.
 
We are often asked what will happen if an inspector finds something wrong
with
a HACCP plan or the way in which it is being implemented. Like the current
inspection system, such a finding will begin a process between the firm and the
Agency that will involve the local district office and, where necessary, Office
of Seafood and other staff in headquarters. We expect that the Office of
Seafood will receive many requests for assistance in order to help resolve
issues that arise during the early inspections. The FDA's reaction will depend
on the public health implications of the findings and we will seek to work with
the firm to resolve the issue in a timely manner.
 
 Unresolved Issues Relating to HACCP
 
We regard the issuance of our seafood HACCP rule as a significant step in the
continuing process of upgrading and modernizing the program. We do not
expect
it to be the only step, as adjustments to the program may be needed. Our
HACCP
program has a pioneering quality to it. Let me address some of the issues:
 
a. Vessels, Transport, and Retail
 
There are gaps in the scope of the final regulations. The final regulations
require HACCP of processors, but not of fishing vessels, common carriers, or
retail establishments. These exclusions generated a lot of public comment
when
first proposed. Commenters correctly pointed out that there are seafood
hazards
that can occur during harvest, or through poor handling during transport and
at
retail.
 
FDA has never directly regulated fishing vessels. The same holds true for
common carriers and retail establishments. The sheer number of vessels,
carriers and retail establishments would overwhelm any existing or foreseeable
Federal regulatory structure. Moreover, whether a mandatory HACCP system
would
be an appropriate regulatory approach for them is not yet clear.
 
We do expect, however, that our program will affect them indirectly. For
many
processors, the condition of their incoming raw materials will be essential to
the success of their HACCP systems, thus their point of receipt for these
materials will be their first critical control point. Our program should provide
them with incentives, as well as with additional leverage, to demand safe
handling practices on vessels and carriers that supply them with raw materials.
 
Whether the regulations actually have this effect remains to be seen. FDA
continues to explore the question of how best to ensure good handling
practices
by vessels and carriers. For vessels, we are committed to issuing Good
Handling
Practices guidelines that are based on international standards issued by the
Codex Alimentarius Commission. We are also looking at other options as
well,
and have not ruled out a mandatory approach if experience reveals a need for
it. For carriers, we are working with the Departments of Agriculture and
Transportation on a common Government policy concerning the safe
transportation
of all foods, including seafood.
 
b. Evaluation
 
How to evaluate the effectiveness and worth of the mandatory HACCP
program for
seafood raises issues that have not fully been solved. Consumer confidence in
seafood, for example, will not increase simply because FDA has required
something called HACCP. The public, the Congress, and the industry itself all
have a right to know what this program is accomplishing.
 
The most relevant accomplishment would be a measurable decrease in
seafood-borne illnesses. We certainly expect that a decrease will occur. The
system is affected by underreporting of foodborne illnesses and other factors
that tend to skew the data in certain ways. We are, therefore, looking for
surrogate ways to evaluate the program.
 
 "LEVERAGING" OUR RESOURCES
 
The optimum frequency of inspection of seafood processors is subject to
reasonable debate. The National Academy of Sciences, in its study of seafood
safety, concluded that an increase in frequency would have no bearing on
safety. Nonetheless, we are always looking for ways to optimize the number
of
inspections. HACCP helps by making our inspections more effective and
efficient, but it is not a substitute for regulatory verification through
inspections.
 
In the area of imports, it has been pointed out that FDA physically examines
less than 5 percent of all "lots" of seafood offered for import into the United
States. 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, the imported products that are detained without physical
examination, or the fact that imports receiving further processing in the United
States become subject to domestic inspection. Moreover, the European Union
and
5 countries with highly advanced regulatory programs for seafood -- Canada,
Iceland, Norway, Australia, and New Zealand -- provide 40 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.
 
One of the challenges to our program, therefore, is to increase our coverage
by
finding new ways to leverage our resources. We hope that some new avenues
I
will describe next may be available to us.
 
 Domestic Inspections, Sampling, and Analysis
 
As I indicated earlier, the States conduct their own inspections of processors
within their borders. Except where we have a contractual relationship with a
State to perform inspections for us, we have not traditionally counted State
inspections. Consequently, the total number of inspections performed by
Federal
and State inspectors is unknown.
 
There are several reasons for this. First, States often inspect in their own
way and for their own purposes. In other words, there is not always
consistency
among inspection regimes. Second, Federal and State data systems are not
always
compatible; it is not always possible to integrate the data from State
inspections into the Federal data system.
 
Nonetheless, FDA and the States are beginning to work together to overcome
these problems and leverage resources through Federal/State partnership
agreements in a number of areas, including seafood. So far, for seafood, these
partnerships have focused on specific types of problems, like decomposition,
and
have involved activities such as collecting and analyzing samples. We are now
interested in developing partnerships for safety based on HACCP systems and
HACCP-based inspections. HACCP has the potential to put us all on the same
page, so to speak, in terms of philosophy, procedure, and the generation of
data.
 
FDA's seafood HACCP initiative is a funded Federal program. But to the
extent
that we and the States can find ways to divide our inspection work load in
ways
that are mutually advantageous, we all benefit and, more importantly,
consumers
benefit.
 
 Agreements with Other Countries
 
Under U.S. law, nations wishing to export beef and poultry to the United
States
must have been the subject of a prior determination by the USDA that the
foreign regulatory structure is equivalent to that of the United States
relating to the product being exported. No such statutory requirement exists
for seafood. Under the FDC Act, seafood may be denied entry if it is
adulterated or appears to be adulterated. The absence of an agreement
between
the United States and the exporting country does not, alone, cause the food to
be adulterated or create the appearance of adulteration.
 
Nonetheless, the development of agreements between the United States and
its
seafood trading partners is now a high priority for FDA. The purpose of these
agreements will be to establish that the regulatory system of an exporting
country and the regulatory system in the United States are equivalent in their
ability to ensure safety, or each country is willing to commit to the other
that exported product meets the requirements of the importing country. An
agreement would provide for regular verification by both countries. Products
from a country with which the United States has an agreement would not
require
as much examination by FDA as those from other countries. Thus, agreements
with
other countries provide a tremendous potential for leveraging resources and
FDA
could better focus its resources on problem areas.
 
Under our HACCP regulations, importers will not have to take steps to verify
that their foreign suppliers are operating HACCP systems if the imports come
from a country with which the United States has an agreement. Obviously,
importers are anxious for the United States to negotiate such agreements, and
several countries have indicated to us that they wish to negotiate agreements
with us. The harmonization of international approaches to regulating seafood
safety through HACCP will have 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 seafood.
 
There are several types of agreements that we will pursue. The most
comprehensive type would cover our entire regulatory program and that of
the
other country. In other words, it would cover all species exported by the two
countries to each other, as well as controls for safety, quality, and economic
adulteration. A more limited agreement would be a HACCP equivalency
agreement
for safety only. Other types of agreements could be limited just to certain
species where proper controls are in place. In any event, we expect that the
international part of our program will be extremely active for the foreseeable
future.
 
There is the growing international recognition that HACCP is the norm for the
control of seafood safety hazards. The Codex Alimentarius Commission's
Committee on Fish and Fishery Products is meeting this week to work on the
addition of HACCP principles into Codex guidelines on fish processing. Both
FDA
and NMFS are participating in that meeting.
 
 The Future Of The Seafood Program -- Other Areas
 
The scope of the seafood program is such that there will always be things to
work on. Here is a quick sampling of other areas that we are targeting for
attention.
 
Methylmercury
 
FDA is beginning a process of reevaluation of its action level for
methylmercury in seafood. Methylmercury occurs in seafood primarily in trace
or
very small amounts as a result of its presence in the environment. In very
large amounts it can be neurotoxic in humans. The Agency's action level of 1
part per million was established in 1979. Recently, a significant amount of new
data on the effects of methylmercury on fish eating populations in the
Seychelles Islands and elsewhere in the world have become available. It is
imperative that FDA's action level be reevaluated in light of the new data.
 
We look forward to this process because it will provide us with an
opportunity
to consider at the same time whether the action level approach remains the
correct one, or whether the outcome should be a tolerance, multiple levels
based on factors such as the amount of fish being consumed, or something
else
entirely.
 
Decomposition
 
Decomposition is the problem we see most frequently with seafood. It is not
an
easy area to regulate, as the best and most reliable method of detection is
sensory evaluation for which considerable amount of training and experience
is
needed. As a consequence, the ability to determine whether a fish is
adulterated under the FDC Act due to decomposition is a skill that is not as
widespread as we or the industry would like. Other ways of determining
decomposition would also be useful. Some chemical indicators of
decomposition
have been developed, but more of these are needed.
 
Both of these solutions chase problems after they have occurred. Proper
handling of seafood throughout the chain of distribution can prevent
decomposition from occurring in the first place. Although our mandatory
HACCP
regulations do not cover most decomposition (that is, decomposition not
linked
directly to safety) preventive controls for this problem ought to be explored.
 
FDA intends to explore these issues and to work with other government
agencies,
academia, and industry on them. It is worth noting that one of the issues that
the Codex Committee on Fish and Fishery Products is working on this week is
the
development of international standards for the sensory analysis of fish. This
effort indicates the significance that the international community places on
the control of decomposition by national regulatory authorities.
 
The Columbus Center
 
Parts of FDA's research program are scheduled to move to Baltimore's new
Christopher Columbus Center, located in the Inner Harbor area. The
Columbus
Center has been built to house marine biotechnology and other research
projects. Because it will have areas that will be open to the public, FDA's
activities will become part of the overall public education mission of the
Columbus Center.
 
FDA's activities in the Columbus Center will focus on ways to improve the
safety of molluscan shellfish and on research into marine toxins. As one of
many research tenants in the Columbus Center, we are excited about the
possibilities for collaboration with the larger research community that this
move will provide us. Our presence in the Columbus Center will link FDA to a
national marine biotechnology resource and will allow for direct collaboration
with the Center of Marine Biotechnology of the University of Maryland. We
anticipate that the Columbus Center will help us to attract highly qualified
researchers that will enhance FDA's program.
 
 CONCLUSION
 
As you can see, the FDA seafood program is comprehensive and complex, in
keeping with its mission. This is a time of transition for the program as we
upgrade and modernize it in order to meet the challenges of the twenty-first
century. We greatly appreciate your interest in the program and look forward
to
working with your committee in the future to keep it strong. The United
States
has the safest food supply in the world. The Federal program for seafood must
continue to do its part to ensure that this important and nutritious
contribution to the U.S. diet remains safe and wholesome.
 
I will be glad to answer any questions that you may have.
 
________________________________________________________________________________
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