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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
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 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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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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