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.
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
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
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
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
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
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
It is worth reviewing the kinds of consumer hazards and
problems that can affect seafood.
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
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
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.
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.
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.
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.
- 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
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
THE REGULATORY PROGRAM FOR SEAFOOD
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.
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.
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.
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
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.
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.
Pederallotate 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
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 long-standing 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
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
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,
food-borne 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
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
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
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
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
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 record-keeping
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
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
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
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
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 unsanitary 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
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
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 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
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
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
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
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
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
- 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.
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
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
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.
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
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
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
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
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.
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.