Proposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products

SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt

regulations to ensure the safe processing and importing of fish and

fishery products (hereinafter referred to as seafood). These procedures

include the monitoring of selected processes in accordance with Hazard

Analysis Critical Control Point (HACCP) principles. HACCP is a

preventive system of hazard control that can be used by food processors

and importers. FDA is proposing these regulations because a system of

preventive controls is the most effective and efficient way to ensure

that these products are safe.

DATES: Written comments by March 29, 1994. The agency is proposing that

any final rule that may be issued based upon this proposal become

effective 1 year following its publication.

ADDRESSES: Written comments, data, or information to the Dockets

Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,

12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Philip Spiller, Center for Food Safety

and Applied Nutrition (HFS-401), Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202-254-3885.

For further information concerning the guidance entitled ``Fish and

Fishery Products Hazards and Controls Guide,'' contact: Donald W.

Kraemer (address above).

For further information concerning the economic impact analysis

contained in this proposal, contact: Richard A. Williams, Jr., Center

for Food Safety and Applied Nutrition (HFS-726), Food and Drug

Administration, 200 C St. SW., Washington, DC 20204, 202-205-5271.

SUPPLEMENTARY INFORMATION:

I. Overview

The purpose of these proposed regulations is to establish mandatory

preventive controls to ensure the safety of seafood products sold

commercially in the United States and exported abroad. These preventive

controls will be based on a system known as HACCP. HACCP is a system by

which food processors and importers can evaluate the kinds of hazards

that could affect their products, institute controls necessary to keep

these hazards from occurring, monitor the performance of these

controls, and maintain records of this monitoring as a matter of

routine practice.

FDA is proposing to require that domestic and foreign processors

and importers adopt HACCP controls to prevent the occurrence of hazards

that could affect the safety of these seafood products for consumers.

If these regulations are adopted, FDA will review the adequacy of HACCP

controls as part of its program of mandatory inspections and import

examinations. Such a review will occur in addition to traditional

inspection activities. FDA is also encouraging, but not proposing to

require, that processors and importers adopt the same types of controls

for nonsafety hazards relating to economic adulteration and quality.

FDA is proposing to make HACCP mandatory for the seafood industry

for the following reasons:

1. Adoption of HACCP controls by the seafood industry, coupled with

inspections by FDA based on the HACCP system, will produce a more

effective and more efficient system for ensuring the safety of seafood

products than currently exists. The current inspection system places

too great a burden on Government inspectors to uncover problems and to

take regulatory action to address those problems. HACCP places primary

responsibility upon the industry to demonstrate that hazards are

understood and are being prevented.

2. A nationally mandated HACCP system will provide a basis for

enhanced consumer confidence in the safety of seafood products.

Consumers should not be afraid to eat foods, such as seafood, that are

recommended as useful lower fat and lower saturated fat substitutes for

higher fat meats (Ref. 1, p. 13; Ref. 2, p. 21).

3. The know-how for applying HACCP to seafood is in an advanced

state of development. A considerable amount of work on applying HACCP

to seafood has already been done by some States, academia, and the

Federal Government as well as through cooperative activities between

the Federal Government and industry and through independent industry

efforts.

4. Seafood industry representatives have urged the Federal

Government to institute a mandatory, HACCP-type inspection system for

their products.

5. A nationally mandated HACCP-type system of controls appears to

be a prerequisite for continued access to world markets.

II. Safety

A. Background

Ensuring the safety of seafood presents special challenges to both

the industry that produces it and to Government agencies charged with

protecting the public health. Seafood is unique in many respects. While

often thought of as homogeneous in nature, seafood is actually a

variety of products encompassing literally hundreds of species that

have little in common other than an aquatic origin. Collectively,

seafoods have perhaps the most diverse and complex microbiology of any

food commodity (Ref. 3, p. xi).

The range of habitats for edible species is also extraordinary and

diverse ranging from cold to warm water, bottom dwelling to surface

feeding, deep sea to near shore, and fresh water to saltwater. Fish are

exposed to the bacteria and viruses that naturally occur in their

environment as well as to those that enter the water through pollution.

Chemicals, some of which are toxic to humans, can accumulate in fish as

well. Fish can also accumulate natural toxins and parasites that are

specific to marine animals. As a consequence, fish are subject to a

wide range of hazards before harvest.

B. The Safety Data

The question of how safe is the seafood in the marketplace has been

the subject of public debate in recent years. This debate has occurred

partly because precise data on the numbers and causes of foodborne

illnesses in the United States do not exist. Foodborne illnesses tend

to be significantly underreported to public health authorities. Data on

foodborne illnesses that are meaningful from an epidemiological

standpoint are difficult and expensive to develop.

The Centers for Disease Control and Prevention (CDCP) of the U.S.

Public Health Service (PHS) compiles data in its Foodborne Disease

Surveillance System that are reported from State and local health

authorities. All foodborne illnesses are underreported to this system

(Ref. 4).

Nonetheless, CDCP data are the best available and can at least be

used to identify trends and emerging concerns about various diseases

(Ref. 5, p. 219). The data suggest that most seafood-related illnesses

result from certain natural toxins in finfish and from viruses in

molluscan shellfish consumed raw or partially cooked (Ref. 4). The wide

range of other hazards that can affect seafood undoubtedly result in

illnesses, but the available data indicate that such illnesses are not

as common. Thus, according to the CDCP data, the actual occurrence of

problems tends to be limited relative to the range of hazards that

could cause problems and tends to be associated with a minority of

commercially available species.

In the CDCP system, seafood accounted for 4.8 percent of reported

cases of foodborne illness for the period 1973 to 1987 (Ref. 4).

However, as CDCP has pointed out, variations in rates of underreporting

among different foods and varying etiologies make it impossible to

compare safety among different foods based solely on CDCP data (Ref.

4). This is certainly true for seafood. Some seafood-related illnesses

tend to be overreported to CDCP's system relative to other foodborne

diseases, due largely to their distinctive characteristics, while

others are probably underreported relative to other causes because they

are less distinctive and more difficult to diagnose (Ref. 4).

FDA has attempted to determine the relative safety of seafood

through risk assessment. The results of this effort indicate that the

risk of illness associated with molluscan shellfish consumed raw or

partially cooked is greater than for any cooked flesh food. However,

seafood overall is as safe or safer than other flesh foods in terms of

frequency of illness (Refs. 5, p. 25; and 6).

The conclusions of the National Academy of Sciences' (NAS)

Institute of Medicine, in its 1991 report entitled ``Seafood Safety,''

are consistent with the CDCP data and the FDA risk assessment.

According to NAS, ``Most seafoods available to the U.S. public are

wholesome and unlikely to cause illness in the consumer'' (Ref. 7, p.

1). Moreover, in reviewing the CDCP data, the report noted that the 23

percent increase in seafood consumption in the United States in the 10-

year period ending 1989 was not accompanied by a concomitant increase

in reported seafood-borne illnesses (Ref. 7, p. 27). Nevertheless, as

NAS pointed out, ``there are areas of risk'' (Ref. 7, p. 1). The report

addressed at some length virtually every possible risk that could

affect seafood and made numerous recommendations relating to existing

and proposed control measures. NAS recommended that improvements be

made in the present system of regulatory control (Ref. 7, p. 1) and

repeatedly recommended HACCP controls wherever appropriate.

``Inspection and testing should focus on actual problems (as in HACCP

systems),'' NAS concluded (Ref. 7, p. 16).

C. The Principal Hazards

The most notable seafood-related hazards involve the following:

1. Bacteria

Because bacteria either naturally live in, or can survive in,

aquatic habitats, there are a large number of pathogenic bacteria that

can be found in seafood, particularly molluscan shellfish. Many of

these bacteria are far more harmful to specific human subpopulations,

such as the elderly, immunocompromised, or persons with specific

underlying diseases, than to the population as a whole. The size of

these subpopulations is increasing, however. Therefore, concerns about

bacterial contamination of seafood, particularly molluscan shellfish,

are increasing.

In the United States, 4.4 percent of botulism outbreaks have been

attributed to seafood. The predominant type of botulism organism in

aquatic environments is the kind most readily destroyed by heat. Thus,

many types of processing, if done properly, can negate the risk of

botulism from seafood. Nonetheless, with the trend toward greater use

of modified atmosphere and vacuum packaging (i.e., packaging that

excludes oxygen) to enhance the shelf life and the desirability of

refrigerated foods, traditional controls need to be enhanced because

Clostridium botulinum can grow in the absence of oxygen.

Other bacteria of concern include Listeria monocytogenes, a

hazardous foodborne microorganism that is ubiquitous in nature and is

commonly found in food processing environments; Salmonella, which is

not a marine organism but can contaminate seafood through improper

handling and sanitation practices; and Staphylococcus aureus, another

pathogen associated with sanitation and handling (Ref. 8, pp. 14 and

15).

2. Viruses

Several viruses that are infectious to humans enter aquatic

habitats through sewage. These viruses can concentrate in shellfish and

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 and Norwalk-like agents,

which are linked to the consumption of contaminated raw or undercooked

molluscan shellfish (Ref. 7, p. 30).

3. Natural Toxins

Problems associated with naturally occurring toxins in fish have

been recognized for centuries. Ciguatera poisoning is perhaps the most

significant problem associated with a natural toxin. The toxin is

produced by microscopic organisms and can be transmitted to humans

through the consumption of finfish that have eaten these organisms

through the food chain (Ref. 7, p. 89). The larger, more predacious

fish (groupers, snappers, barracuda, amberjack) and reef fish belonging

to the crevally or ulua (Carangidae) family are generally more likely

to contain ciguatoxin than other types of fish (Ref. 7, p. 89). Because

the toxin is heat stable, cooking does not make the fish safe to eat

(Ref. 9, p. 1).

On average, 70 cases of ciguatera poisoning are reported annually

in the United States and its possessions and territories (Ref. 7, p.

89). Deaths are rare, and the acute symptoms of the disease are usually

of short duration; however, neurological symptoms can persist for

extended periods. Ciguatera is geographically localized, with the

majority of illnesses reported from tropical or subtropical areas.

Other toxins of public health concern include domoic acid, which

was detected in seafood from the U.S. Pacific coast for the first time

in the fall and winter of 1991-1992 (Ref. 10, p. 1,113); and saxitoxin,

or paralytic shellfish poison, which has periodically made molluscan

bivalves toxic and has recently affected Pacific Northwest crab

harvests (Ref. 11).

4. Parasites

Parasites, such as anasakid nematodes (round worms), naturally

infect certain fish and ocean mammals (Ref. 12, p. 724). Human

parasitic infections almost always occur from the consumption of raw

(sushi, sashimi) or undercooked fish. Historically, probably no more

than five cases are reported on average in the United States each year

and the likelihood of occurrence is estimated to be very low (Ref. 5,

p. 25). Problems with parasites are avoidable through commercial

freezing of the raw fish before consumption.

5. Chemical Contaminants

The presence of toxic chemicals in the aquatic environment creates

the potential for contamination of seafood products. These chemicals

include pesticides; other industrial chemicals, such as polychlorinated

biphenyls; heavy metals, such as lead, cadmium, and mercury; and

petroleum hydrocarbons.

Marine species, especially deep sea varieties, comprise the

majority of seafood consumed in this country. This seafood has little

potential to contain most chemical contaminants at levels of

toxicological concern (Ref. 13, p. 6). However, there are some

contaminants that can be present at significant levels, methylmercury

in certain species being perhaps the most notable. Fresh water species,

especially nonmigratory bottom feeders, are generally the most exposed

to a variety of chemical contaminants (Ref. 13, p. 6).

6. Decomposition

Finfish are generally regarded as being much more perishable than

terrestrial flesh foods (Ref. 14, p. 3). Decomposition is a problem

with seafood products frequently encountered by FDA and is the subject

of the majority of regulatory actions taken by the agency against

violative seafood products (Ref. 15). It is largely an economic and

aesthetic problem; however, in some species it can lead to illness

because of the formation of scombrotoxin (histamine) during

decomposition. Scombroid poisoning is completely preventable by proper

handling, i.e., by proper time and temperature controls.

D. Additional Factors Affecting Safety

Unlike beef and poultry, seafood is still predominately a wild-

caught flesh food that frequently must be harvested under difficult

conditions and at varying distances from processing, transport, and

retail facilities. There are nearly 100,000 vessels in the U.S. fishing

fleet alone (Ref. 7, p. 22). These conditions, distances, and duration

of fishing trips, can tax any system of controls designed to ensure

safety and prevent spoilage.

In addition, several hundred vessels are seagoing processing

factories, many of which operate in remote waters. For regulators,

these ships that process at sea can be difficult and expensive to reach

while they are operating, and individual inspectors face hazards such

as ship-to-ship transfers on the high seas.

There may be as many as 350 commercially marketed species (Refs.

16; and 19, p. 35). Consumer preferences for one species over another

and significant price differences between species can lead to economic

fraud through the substitution of cheaper species for more expensive

ones.

Unlike beef and poultry, seafood is subject to significant

recreational harvest. Beyond the 15 pounds of seafood consumed per

capita from commercial channels, an additional 4 pounds may be consumed

from recreational sources. Some recreational catch finds its way into

commercial channels as well.

Thus, recreational fishing can have a bearing on the safety of

commercial seafood. Commercial fishermen avoid or are prohibited from

harvesting from polluted areas, but recreational fishermen, especially

recreational harvesters of molluscan shellfish, might not be as aware

of, or might ignore, local advisories or water closures. Processors

need to be aware of and control the source of their raw materials, and

importers must ensure that their shipments are obtained from acceptable

sources.

An additional complicating factor in ensuring the safety of seafood

is the fact that no other flesh food is imported in the quantity, or

from as many countries, as seafood. Imports include finished products

as well as products to be further processed domestically. Over 55

percent of seafood consumed in this country is imported. It comes from

approximately 135 countries. Several of these countries have advance

regulatory structures for seafood safety, but many others are

developing nations that lack structures for seafood regulation

comparable to those in more developed nations (Ref. 35, pp. 113 and

114).

Therefore, it is of utmost importance, that those who handle and

process seafood commercially, including importers, understand the

hazards associated with this type of food, know which hazards are

associated with the types of products with which they are involved, and

keep these hazards from occurring through a routine system of

preventive controls. The seafood industry, indeed, the food industry as

a whole, must be primarily responsible for the safety and quality of

the food that it produces. The regulator's primary role should be to

verify that the industry is meeting this responsibility and to take

remedial action when it is not. The alternative of relying solely on

Government inspectors to identify problems and provide solutions would

involve enormous costs to the public and would be extremely

inefficient, assuming it could be done at all.

For the most part, seafood processors and importers are not

required, through licensure or examination, to understand seafood

hazards as a prerequisite to being able to do business. (There are

exceptions. A few States, such as Alaska, do require processors to

conform to HACCP as a condition of doing business (Ref. 17).) While

many processors and importers have such an understanding, this

knowledge is not universal. It is not unusual for FDA to receive

inquiries about safety requirements and related matters from those who

wish to process or import seafood, or who already do, that indicate a

lack of awareness of hazards specific to their products. Most of the

industry does not have HACCP-trained personnel, and many firms lack

dedicated quality assurance personnel (Ref. 18, p. 35).

Seafood processing in the United States is done by several thousand

businesses, many of which are small, old, and family operated (Ref. 19,

p. 35). This situation is in contrast to the beef and poultry

industries, in which market share is concentrated among a small number

of large processors. Seafood firms tend to be small, fragmented

operations sized in reference to anticipated benefits, because of the

significant, uncontrollable risks involved in this business (Ref. 5, p.

225). Also, because many harvests are seasonal, many of their

operations are intermittent (Ref. 20). The seasonal nature of the

industry can affect worker skills and practices relating to safety,

while older facilities and equipment can be more difficult to maintain

in terms of adequate sanitation and proper processing and storage

temperatures (Ref. 20).

III. The Need for Regulations

A. The Current Inspection System Is Not Well-Suited to Seafood

Seafood processors are subject to periodic, unannounced, mandatory

inspection by FDA. Seafood processors and importers are also able to

purchase inspection services from the National Marine Fisheries Service

(NMFS) of the U.S. Department of Commerce. These inspection services

have been primarily trade-related, such as grading.

Until recently, FDA's overall regulatory program for seafood

received slightly over $20 million per year. Because much of the

program involves activities such as research, laboratory analyses, and

technical assistance and training to States, a substantial portion of

it has tended to be invisible to the general public. Public interest

and debate tends to focus on the more visible aspects of regulation,

primarily inspection. The congressional debate of the past several

years over the adequacy of the Federal regulatory program for seafood

has been framed, more often than not, in terms of the need for

mandatory inspection. Traditionally, FDA inspected the equivalent of a

quarter of its total domestic inventory of seafood establishments per

year.

Since 1990, however, FDA has received significant funding increases

for seafood. The current budget of slightly over $40 million has

permitted the agency to increase the frequency of its inspections. It

now inspects so-called high risk processors at least once per year and

all others at least biennially. (Because States also inspect

processors, the collective frequency is actually higher.)

Even so, because of seafood's unique characteristics (e.g., the

fact that it is predominantly wild caught and presents a wide range of

possible hazards), it is questionable whether the current regulatory

system, which was developed for the general food supply, is best suited

for the seafood industry. The current system provides the agency with a

``snapshot'' of conditions at a facility at the moment of the

inspection. However, assumptions must be made about conditions before

and after that inspection on the basis of the ``snapshot,'' as well as

about important factors beyond the facility that have a bearing on the

safety of the finished product. The reliability of these assumptions

over the intervals between inspections creates questions about the

adequacy of the system, particularly, as the congressional hearings on

the subject over the past several years have shown, for seafood.

FDA's inspections are based upon the regulations on current good

manufacturing practice in manufacturing, packing, or holding human food

at part 110 (21 CFR part 110). For the most part, these guidelines

consist of broad statements of general applicability to all food

processing on sanitation, facilities, equipment and utensils,

processes, and controls. HACCP-type controls are listed as one of

several options available to prevent food contamination

(Sec. 110.80(b)(13)(i)) but they are otherwise not integral to the

guidelines.

Current Federal inspection and surveillance strategies verify the

industry's knowledge of hazards and preventive control measures largely

by inference, i.e., whether a company's products are in fact

adulterated, or whether conditions in a plant are consistent with

current good manufacturing practice (CGMP). Consequently, the current

system places the burden on the Government to prove that a problem

exists rather than on the firm to establish for itself, for the

regulator, and for consumers, that adequate controls exist to ensure

safety. The current approach is inefficient and, unless Government

inspections are conducted with some frequency, can lead to conditions

that can elevate risk and erode public confidence. It also has the

potential to cause some inequities. While the same standards of

adulteration apply to all products in interstate commerce, processors

and importers who use a system of preventive controls coupled with

adequate monitoring must compete against those who do not.

A survey conducted by FDA in 1992-1993 of manufacturers of ready-

to-eat seafood products revealed conditions that strongly suggest the

need for a system that emphasizes preventive controls to ensure that

products are safe by design. Ready-to-eat products require special care

in processing because they do not require, and are unlikely to receive,

any further cooking by consumers that would destroy pathogenic

microorganisms. The survey focused on whether preventive controls exist

rather than on the results of expensive end-product sampling. The

agency found that, in significant measure, firms have not been

employing the types of preventive processing steps necessary to ensure

a safe and wholesome product. Some of the preliminary results are as

follows (Ref. 21).

1. Fifty-four percent of the firms that pasteurized products had

not established the adequacy of their pasteurization process to destroy

pathogenic microorganisms such as the spores of C. botulinum, type E,

which can cause significant illness and death in humans. The

pasteurization process is not simple and must be done with precision in

order to consistently deliver a thermal process that will inactivate

the spores of C. botulinum, type E and prevent recontamination of the

product after it has been heat treated. The CGMP at part 110 state that

pasteurization must be adequate. Realistically, the only way for FDA to

determine, or at least infer, the adequacy of the process now is to

analyze samples of finished product for the presence of pathogens.

2. Twenty-seven percent of the firms that pasteurized products did

not have temperature-indicating devices on their pasteurizers, and 35

percent did not have temperature-recording devices. Temperature

monitoring is essential to ensure that a thermal process is properly

controlled. Part 110 addresses temperature indicating and recording

devices only for refrigeration, while pasteurization involves cooking.

A temperature-recording device is important for purposes of preventive

control because it provides a continuous history of the cooking step.

3. Forty-two percent of firms that pasteurized products did not

perform can seam evaluations or performed them less frequently than

every 12 hours. Such evaluations are necessary to ensure that there

will not be microbiological contamination of the finished pasteurized

product. FDA's regulations for the processing of low acid canned food

(parts 108 and 113 (21 CFR parts 108 and 113)) require such evaluations

every 4 hours as an HACCP-type control, but products that need

refrigeration (e.g., pasteurized products) are outside the scope of

those regulations. Again, part 110 states only that the pasteurization

process should be adequate. FDA must conduct end-product sampling and

analysis to determine, or at least infer, whether a pasteurization

process is adequate.

4. Forty-three percent of firms that pasteurized products did not

perform cooling water sanitizer strength checks to ensure that the

pasteurized product would not be contaminated during this process. The

presence of a sanitizer in the cooling water is important to prevent

contamination of the product after pasteurization because during

cooling, some water can be drawn into hot cans. Part 110 does not

specifically mention a cooling water sanitizer. The ``adequate''

provision cited above is the closest relevant provision, and FDA must

conduct end-product sampling and analysis to determine, or at least

infer, whether a pasteurization process is adequate.

5. Eighty-four percent of the firms did not monitor the internal

temperature of products during the various stages of processing. Such

monitoring is important because time/temperature abuse can result in

the growth of pathogenic microorganisms, decomposition, and, in some

cases, the formation of histamine. Part 110 states that all reasonable

precautions should be taken to prevent contamination and recommends

temperature control as one type of precaution. Again, end-product

sampling is the only practical way for FDA to measure compliance.

6. Fourteen percent of the firms did not have temperature-

indicating devices on their finished product coolers, and 89 percent

did not have temperature-recording devices. Part 110 states that

processors should have one or the other but does not specifically

require that processors monitor either one. While 14 percent were out

of compliance, most who were in compliance opted for the control that

did not provide a continuous record.

7. Thirty-one percent of the temperature-indicating devices on

finished product coolers were more than 5 deg.F out of adjustment.

Fifty-five percent of these were giving readings that were too low. For

these, the deviation would permit the growth of pathogenic

microorganisms, decomposition, and histamine formation. Part 110

specifically states that thermometers should be accurate. Five degree

deviations are clearly out of compliance. A significant percentage of

firms surveyed were not paying attention to a significant preventive

control.

8. Twenty-three percent of temperature-indicating devices on

pasteurizers and 80 percent of such devices on finished product coolers

were never calibrated. Again, part 110 calls for accuracy. The failure

to calibrate means that these firms have no assurance that their

devices are accurate. A preventive control is not being applied, and

thus a significant percentage of processors are apparently relying on

Government investigators to determine accuracy during inspections.

Also, this deficiency may account in part for the deviations described

in section III.A.7. of this document.

9. Twenty-nine percent of temperature-recording devices on finished

product coolers were never checked for accuracy, while 34 percent of

such devices on pasteurizers and 74 percent on finished product coolers

were checked less frequently than once a month. Temperature-recording

devices are easily jarred out of calibration and must be routinely

adjusted to agree with an accurate temperature-indicating device. Thus,

they need to be checked for accuracy at least at the start and the end

of each processing day in order to determine whether they remained

accurate throughout the day's production.

10. Forty-eight percent of the firms cleaned and sanitized the

processing equipment less frequently than every 4 hours, while 13

percent cleaned and sanitized less than every 12 hours. Part 110 states

that sanitation practices should occur as frequently as necessary. In

order to control salmonella and other undesirable bacteria within a

facility, the frequency should be at least every 4 hours, and more

frequently if feasible. This frequency helps reduce the likelihood that

these microorganisms will enter a rapid phase of growth during which

their numbers increase logarithmically (Ref. 22, p. 114; Ref. 23, p.

2).

11. Twenty-two percent of the firms did not perform plant or

equipment sanitation audits (i.e., inspections), and 35 percent did not

check the strength of hand or equipment sanitizing solutions. These

results reveal that a significant number of plants are not checking up

on themselves to ensure that they were doing an adequate job of

sanitation. In such plants, the only check on sanitation is provided by

the Government investigators who visit the plant.

Other survey and inspection findings by FDA and others strongly

indicate that the seafood industry does not always operate on the basis

of preventive controls. For example, recent FDA and State surveys

showed that many processors of smoked and smoke-flavored fish are

operating outside of the parameters that have been demonstrated through

scientific research to be necessary to ensure that the hazard from

botulism is adequately controlled. These parameters are process times

and temperatures and salinity levels. A number of firms surveyed did

not even know their own operating parameters, let alone the

scientifically established ones (Refs. 24, 25, and 26). For seafood

products such as these that require no cooking by the consumer,

preventive measures by the processor to eliminate C. botulinum, type E

to the maximum extent possible are critically important.

B. Alternatives Other Than HACCP

Continuous visual inspection of seafood is not a viable

alternative. Few hazards associated with seafood are detectable through

visual inspection. Moreover, the costs of such a system would likely

exceed the nearly half-billion-dollar public outlay now required to

operate this kind of system for meat and poultry.

Another alternative would be to direct significant additional

resources toward greatly increasing the frequency of FDA's inspection

of seafood, as well as increasing the agency's sampling, laboratory

analysis, and related regulatory activities with respect to seafood.

While thousands of samples of domestic and imported seafood products

are collected each year for analysis in FDA laboratories, and these

samples are scientifically designed to represent a broad range of

products, they are generally perceived by the public to represent only

a small fraction of the total poundage of seafood consumed in this

country. Substantial new expenditures would be needed to increase

laboratory analyses to nationally statistically significant levels.

Even if the funds for increased inspection and increased sampling

and analysis were available (which they are not), this approach alone

would likely not be the best way for the agency to spend its money to

protect the public health. Reliance on end-product testing involves a

certain amount of inefficiency that can require very large sample sizes

to overcome. NAS recently observed that ``the statistical uncertainties

associated with lot sampling make this an unreliable method for

ensuring safety of food products * * *'' (Ref. 7, p. 283). FDA has

traditionally sought to minimize this type of inefficiency by targeting

its efforts based on its experiences, but some inefficiency is

unavoidable. NAS recommended the HACCP system as an alternative (Ref.

7, p. 283).

C. Current Import System Is Not Well-Suited to Seafood

Similar considerations apply to imports. FDA does not generally

inspect processing facilities in other countries to determine whether

seafood products are being prepared, packed, or held there under

appropriate conditions. Such inspections are extremely costly and

require an invitation from the foreign country. Traditionally,

therefore, FDA's primary strategy for seafood imports has involved: (1)

Reviewing all customs entries documents to determine which imported

products to examine or sample; (2) conducting wharf examinations of

selected products based on that review; and (3) sampling and laboratory

analyses as appropriate.

One concern about this process that has been voiced with some

regularity in the media, Congress, and elsewhere is that FDA physically

looks at less than 5 percent of all imports. This figure is somewhat

misleading because it refers to seafood lots that can vary

substantially in size. Also, it does not take into account such factors

as the representative nature of the examinations, FDA's automatic

detention program for imports that requires importers of products with

a history of problems to obtain a laboratory analysis and certification

prior to entry, or the fact that imports receiving further processing

in the United States become subject to domestic inspection.

Nonetheless, it is certainly true that most imported seafood is not

physically sampled or examined by a Federal health official.

The total number of customs entries for seafood each year is

approaching 200,000 (Ref. 27) from about 135 countries (compared to

about 33 countries for beef and poultry (Ref. 28)), and huge sums of

money would be needed to enable FDA to increase its physical

examination and sampling program to nationally, statistically

significant levels. Still, many developing countries export seafood

products to this country, and their regulatory protections tend to be

comparatively weak, if they exist at all. Processing conditions in such

countries do not always meet U.S. standards for sanitation.

While many importers are conscientious about the safety and quality

of the products that they import, others have little understanding of

potential hazards. The denial of entry of a violative lot may be

regarded as simply a cost of doing business, which is offset in many

cases by insurance purchased against just such an eventuality. Such

policies are identified as ```FDA rejection' insurance'' and usually

the premium is 2 to 3 percent of the value of the shipment (Ref. 29).

It is reasonable to assume that this cost is being passed on to the

consumer. The insurance also permits importers to buy seafood from

foreign processors without first ensuring that it meets FDA

requirements, i.e., that it is safe, wholesome, and properly labeled.

This system leaves much to be desired. It, too, is a ``snapshot''-

type approach that places a significant burden on the Government to

uncover problems without fostering or promoting industry

responsibility. It lacks the preventive controls that the agency has

tentatively concluded are the minimum necessary to ensure safety.

Moreover, it has not provided full public confidence in the safety of

imported seafood.

D. Public Confidence

Continuing public concerns about the safety of seafood provide

additional evidence that the current regulatory system is not well-

suited for seafood. Consumers have become increasingly concerned about

the effects of pollution on seafood. Medical wastes washing up on

beaches, ocean dumping of toxic wastes, chemical run-off, and multiple

oil spills continually dramatize the fact that bodies of water, no

matter how large, can be adversely affected by human activity.

Media and other public attention on seafood safety and quality, and

on the adequacy of the current regulatory program for seafood, has been

substantial in recent years, and there is no reason to expect that this

attention will decrease. Problems with some seafood products draw

attention to, and has tended to raise concerns about, all seafood, a

situation that is bad for consumers because seafood is a low fat

product, and bad for an industry that can ill afford it.

Several hearings on the sufficiency and direction of the Federal

seafood safety program have been held in both houses of Congress since

in 1989. In addition, numerous bills have been introduced in Congress

for the stated purpose of establishing a Federal program of mandatory

inspection of seafood. Different bills passed the House and the Senate

in 1990 but were not reconciled before the end of the 101st Congress.

This legislative activity has tended to reinforce the view that the

public is placed at some risk because no Federal mandatory program for

seafood exists. While this view is inaccurate in a number of respects,

it is fueled in part by the notable differences in the frequency with

which regulatory agencies inspect the processors of different types of

flesh foods. As stated above, beef and poultry slaughterhouses are

subject to continuous visual inspection under programs operated by the

U.S. Department of Agriculture (USDA).

Public concerns about seafood regulation persist despite the recent

increases in Federal resources and inspections for seafood. A major

U.S. newspaper recently published an article entitled ``A Sea of

Uncertainties,'' which expressed anxiety about the coverage of seafood

inspection. ``The odds are,'' it observed, ``that the bit of fish you

cook tonight got to your table without ever being poked or prodded or

even glanced at by a government inspector'' (Ref. 30).

No realistic system, however, could possibly look at every piece of

fish. Moreover, in the current budget climate, improvements in the

system for ensuring the safety of seafood will likely have to be

qualitative rather than quantitative. Estimated combined Federal,

State, and local outlays for regulatory activities relating to seafood

are about $100 million annually (Ref. 31), but pressures to cut back

funding exist at all of these levels.

IV. The HACCP Option

Thus, the Government must find new approaches to food safety that

enable it to become more efficient and minimize costs wherever

possible. A new paradigm is needed for seafood inspection, one that

provides an ongoing, scientifically established system of intensive,

preventive monitoring but that does not require undue resources.

When faced with similar pressures, Canadian health authorities

responsible for seafood safety came to the following conclusion:

One of the key challenges will be to endure the scrutiny of the

informed consumer and demanding marketplace * * *. The Canadian

Government, as well as other western governments will be under

constant pressure to limit spending as the aging population places

more and more demands on services and as the Federal deficit is

addressed. This means inspection programs cannot expect to have ever

increasing resources to meet the challenges of the 1990's. Smarter

and more cost effective ways must be developed to carry out their

mandate.

(Ref. 32, p. 502.)

The ``smarter and more cost effective way'' chosen by the Canadians

is HACCP.

A. What is HACCP?

HACCP is a preventive system of hazard control. Its application to

food production was pioneered by the Pillsbury Company (Pillsbury)

during that company's efforts in the early 1960's to create food for

the U.S. space program. Pillsbury concluded that then existing quality

control techniques could not provide adequate assurance that the food

being produced was not contaminated. The end-product testing necessary

to provide such assurance would be so extensive that little food would

be left for space flights. According to Howard E. Bauman:

We concluded after extensive evaluation that the only way we

could succeed would be to develop a preventive system. This would

require us to have control over the raw materials, process,

environment, personnel, storage, and distribution as early in the

system as we possibly could. We felt certain that if we could

establish this type of control, along with appropriate record

keeping, we should be able to produce * * * a product we could say

was safe. For all practical purposes, if this system was implemented

correctly, there would be no testing of the finished packaged

product other than for monitoring purposes.

(Ref. 33, p. 2.)

In the succeeding years, the system devised by Pillsbury has been

recognized worldwide as an effective system of controls. The system has

undergone considerable analysis, refinement, and testing. FDA believes

that HACCP concepts have matured to the point where they can be

formally implemented for seafood on an industry wide basis.

HACCP consists first of an identification of the likely hazards

that could be presented by a specific product, followed by the

identification of the critical control points in a specific production

process where a failure would likely result in a hazard being created

or allowed to persist. These critical control points are then

systematically monitored, and records are kept of that monitoring.

Corrective actions are also documented.

The National Advisory Committee on Microbiological Criteria for

Foods (NACMCF), which was established by USDA in conjunction with FDA

at the recommendation of NAS, has developed seven widely accepted HACCP

principles that explain this process in greater detail (Ref. 34). These

HACCP principles follow.

1. Hazard Analysis

The first step in the establishment of an HACCP system for a food

process is the identification of the hazards associated with the

product. NACMCF defined a hazard as a biological, chemical, or physical

property that may cause a food to be unsafe for consumption (Ref. 34,

p. 186). The hazard analysis step should include an assessment of both

the likelihood that these hazards will occur and their severity if they

do occur. It should also involve the establishment of preventive

measures to control them. To be addressed by the HACCP system, the

hazards must be such, according to NACMCF, that their prevention,

elimination, or reduction to acceptable levels is essential to the

production of a safe food. Even factors beyond the immediate control of

the processor, such as how the food will be distributed and how it will

be consumed, must be considered because these factors could influence

how it should be processed. Hazards that involve low risk and that are

not likely to occur need not be considered for purposes of HACCP.

NACMCF has developed numerous issues to be considered during hazard

analysis. These issues relate to matters such as ingredients,

processing, distribution, and the ultimate intended use of the product.

FDA urges seafood processors and importers to become familiar with

these issues. They include, for example, whether a food contains any

sensitive ingredients that may present microbiological hazards,

chemical hazards, or physical hazards; whether sanitation practices can

affect the safety of the food that is being processed; and whether the

finished food will be heated by the consumer. For seafood, this

analysis is particularly important because it is consumed raw or

partially cooked to an extent unrivaled for other flesh foods. Examples

of seafoods that are consumed in this way include raw molluscan

shellfish, sushi, steamed clams, and cold smoked salmon.

2. Identify the Critical Control Points in the Process

Points in a manufacturing process that may be critical control

points, as listed by the NACMCF, include cooking, chilling, specific

sanitation procedures, product formulation control, prevention of cross

contamination, and certain aspects of employee and environmental

hygiene. For example, a cooking step that must be operated at a

specific temperature and for a specified time in order to destroy

microbiological pathogens is a critical control point. Likewise,

refrigeration required to prevent hazardous microorganisms from

multiplying or toxins from forming is a critical control point.

3. Establish Critical Limits for Preventive Measures Associated With

Each Identified Critical Control Point

In essence, this step involves establishing a criterion that must

be met for each preventive measure associated with a critical control

point. Critical limits can be thought of as boundaries of safety for

each critical control point and may be set for preventive measures such

as temperature, time, physical dimensions, moisture level, water

activity, Ph, available chlorine, or sensory information such as

texture, aroma, or visual appearance. Critical limits may be derived

from sources such as regulatory standards and guidelines, literature

surveys, experimental studies, and experts.

4. Establish Procedures To Monitor Critical Control Points

Monitoring is a planned sequence of observations or measurements to

assess whether a critical control point is under control and to produce

an accurate record for future use in verification. NACMCF identifies

three main purposes for monitoring: (1) It tracks the system's

operation so that a trend toward a loss of control can be recognized,

and corrective action can be taken to bring the process back into

control before a deviation occurs; (2) it indicates when loss of

control and a deviation has actually occurred, and corrective action

must be taken; and (3) it provides written documentation for use in

verification of the HACCP plan.

As NACMCF points out, continuous monitoring is possible with many

types of physical and chemical methods. For example, temperature and

time for a scheduled thermal process can be recorded continuously on

temperature-recording charts. When it is not possible to monitor a

critical limit on a continuous basis, monitoring intervals must be

reliable enough to permit the manufacturer to determine whether the

hazard is under control.

5. Establish the Corrective Action To Be Taken When Monitoring Shows

That a Critical Limit Has Been Exceeded

While the HACCP system is intended to prevent deviations in a

planned process from occurring, perfection is rarely, if ever,

achievable. Thus, NACMCF states that there must be a corrective action

plan in place to: (1) Determine the disposition of any food that was

produced when a deviation was occurring; (2) fix or correct the cause

of noncompliance to ensure that the critical control point is under

control; and (3) maintain records of corrective actions.

6. Establish Effective Recordkeeping Systems That Document the HACCP

System

This principle requires the preparation and maintenance of a

written HACCP plan that sets out the hazards, critical control points,

and critical limits identified by the firm, as well as the monitoring,

recordkeeping, and other procedures that the firm intends to take to

implement the plan. Secondly, this principle requires the maintenance

of records generated during the operation of the plan.

Ultimately, it is the recordkeeping associated with HACCP

procedures that makes the system work, both from the standpoint of the

HACCP operator (industry) and the regulator. One conclusion in a study

of HACCP performed by the Department of Commerce is that correcting

problems without recordkeeping almost guarantees that problems will

reoccur (Ref. 35, p. 85). The requirement to record events at critical

control points on a regular basis ensures that preventive monitoring is

occurring in a systematic way.

7. Establish Procedures to Verify That the HACCP System Is Working

This process involves: (1) Verifying that the critical limits are

adequate to control the hazards; (2) ensuring that the HACCP plan is

working properly, e.g., that it is being followed, and that appropriate

decisions are being made about corrective actions; and (3) ensuring

that there is documented, periodic revalidation of the plan to make

sure that it is still relevant to raw materials as well as to

conditions and processes in the plant. Government regulatory activities

also help ensure that the HACCP system is working.

B. Specific Applications to Seafood

As NAS has pointed out, most health risks associated with seafood

originate in the environment (Ref. 7, p. 1). Many of these risks are

the subject of research by FDA, the National Oceanic and Atmospheric

Administration (NOAA) of the Department of Commerce, the Environmental

Protection Agency (EPA), and others. This research is designed both to

produce information that will provide a better understanding of the

toxins, bacteria, chemical contaminants, and other phenomena and to

provide a basis for developing more advanced types of controls for

them. Within the limits of existing scientific knowledge, however, the

industry can and should use HACCP to control the source and condition

of raw materials based on an understanding of the likely hazards that

need to be prevented.

The Pillsbury team that first applied HACCP to food production

began with a systematic review of raw materials to ensure that they

were not bringing hazards into the plant. As Bauman pointed out:

This required the development of a familiarity with the raw

materials that was not a normal process in food product development

* * *. The areas of concern ranged from the potential presence of

pathogens, heavy metals, toxins, physical hazards and chemicals, to

the type of treatments the ingredients might have received such as

pesticide applications or a pasteurization step. (Ref. 33, pp. 2 and

3.)

While all these areas that were of concern to Pillsbury are not

germane to all seafoods, they certainly cover the range of hazards to

which seafoods are susceptible.

Of the three most frequently reported seafood-related illnesses,

two are environmentally related: ciguatera in warm water reef fish, as

described previously, and water-borne viruses in molluscan shellfish

consumed raw and partially cooked. While a rapid test to detect

ciguatoxin in fish continues to be the target of research at FDA and

elsewhere, processors and importers can exercise control by ensuring

that they are obtaining fish from responsible sources that are not

harvesting from waters where ciguatoxin is being found.

Ciguatera has been associated with recreational fishing. Processors

and importers should address through HACCP any safety considerations

that might exist with the commercial sale of recreational catch

generally, depending upon species and locale.

For viruses from molluscan shellfish to be controlled, HACCP

measures must be in place to ensure that molluscan shellfish harvested

from polluted waters are not entering commerce. Other key safety

controls relate to proper refrigeration to keep potentially harmful

microbes from reaching dangerous levels.

The third seafood-related illness, scombroid poisoning, is caused

by a toxin created as part of the process of decomposition after a fish

has died. The formation of scombrotoxin can be triggered by time/

temperature abuse anywhere in the commercial system and beyond,

including as early as on the harvesting vessel if good handling

controls are not followed.

FDA is considering whether to develop good handling practice

requirements (not necessarily HACCP) specific to fishing vessels and

invites comment on this matter. FDA has traditionally refrained from

directly regulating fishing vessels, largely because of the huge number

of such vessels in the U.S. fleet, even though it has authority to do

so. FDA invites comment on whether those boats that harvest

scombrotoxin-forming species, or any other specific component of the

fleet, should be subject to mandatory HACCP controls.

Meanwhile, processors and importers of scombrotoxin-forming species

can exercise HACCP controls aimed at ensuring that their incoming raw

materials or imported shipments have not been time/temperature abused.

Because any HACCP plans for such processors or importers would be

clearly inadequate if scombrotoxin were not identified as a hazard and

appropriate controls were not in place and systematically monitored,

processors and importers should consider placing time/temperature

requirements on vessel owners as a prerequisite to doing business.

HACCP can also be applied to control of hazards from chemical

contaminants, even though the full range of possible chemical hazards

is still imperfectly understood. Government and academia have important

roles to play in researching the toxicities of these chemicals, in

monitoring them, and in performing various forms of risk assessment. In

some cases, these efforts may result in the establishment of national

maximum limits. In other cases, regional advisories may be more

appropriate. The seafood industry has a responsibility to know whether

chemical hazards are associated with the species they are handling,

whether the occurrence of such hazards depends on harvest site or other

factors, and whether a sampling and analysis program on their part

would be appropriate. Processors and importers should monitor the

origin of raw materials and imported shipments to ensure, for example,

that harvest did not occur in locations subject to public health

advisories.

These are but a few examples of environmentally related hazards to

which HACCP can be applied. HACCP controls can also ensure that hazards

are not being created inside a processing facility through improper

handling, cooking, or storing.

C. Regulatory Considerations

From a regulatory standpoint, inspections of processing facilities

and of importers' plans and records would become more efficient and

would be likely to have a much greater impact if HACCP controls were in

place. A key feature of an inspection system tied to implementation of

HACCP is access by Government investigators to the HACCP plan and to

monitoring records kept under that plan. In contrast to the

``snapshot'' provided by current inspections, examination of HACCP

records will enable an investigator to see how the processing facility

or the importer operates over time. It will enable an investigator to

determine whether problems have occurred, and how they were addressed.

It will also enable an investigator to spot trends that could lead to

problems, and thus to help prevent them from occurring. Additionally,

it will enable the regulator to review the adequacy of the processor's

or importer's preventive control system itself. Under such an

inspection system, inadequate preventive controls would warrant

remedial or regulatory action regardless of whether the processor's or

importer's product is actually contaminated or unsafe.

HACCP is not a zero risk system, however. Problems in food

production and processing will still occur. HACCP systems are designed

to detect and document those problems, so that they can be corrected as

quickly as possible. Thus, regulatory action would not be warranted on

the basis of the mere occurrence of processing problems. It would be

warranted, though, if the HACCP system is not functioning properly to

detect and correct the problems, or if adulterated food is allowed to

enter into commerce.

An inspection program tied to mandatory industry adoption of the

HACCP system would not be industry self-certification, nor would it be

deregulatory. An investigator under such a program would perform HACCP

reviews but not to the exclusion of other inspection activities. Thus,

it is highly doubtful whether any falsification of records would go

undetected. Investigators are taught to recognize falsification of

records, and the inspection techniques they use would likely reveal any

instances in which the records do not reflect actual conditions and

practices. Falsification of records carries strict penalties under

Federal law.

Unlike the other inspection options discussed previously that would

involve continuous or high-frequency inspection and commensurate costs,

an inspection system tied to HACCP would not necessarily require an

increase over current inspection frequencies. Recordkeeping and record

inspection will provide the inspector, however, with a broader view.

Moreover, to the extent that States adopt equivalent inspection

programs in response to these proposed regulations, the resultant

network of consistent inspections would, in effect, increase the

frequency of inspections at no additional cost. The value to the nation

of such a network would be substantial.

FDA recognizes that many States are under considerable pressure to

cut back funding in areas where a Federal presence also exists. For

seafood, however, FDA urges that the States maintain their programs,

strengthen them to the extent possible, and work with the agency to

integrate them into a HACCP-based, Federal/State network. Such an

approach would be consistent with recommendations relating to the role

of States made by NAS in its 1991 report on seafood safety (Ref. 7, p.

16). FDA especially invites comment on how the proposed FDA program

should mesh with an existing State HACCP program for seafood, such as

the program that exists in Alaska, so that inconsistent Federal and

State HACCP requirements are not imposed.

V. The Proposal

A. Decision To Propose To Make Use of HACCP Mandatory

For the foregoing reasons, FDA has tentatively concluded that a new

system of regulatory controls for seafood is necessary, and that HACCP

is the appropriate system. Therefore, FDA is proposing to add part 123

to establish procedures for the safe processing and importing of fish

and fishery products. FDA is proposing these procedures under sections

402(a)(1), 402(a)(4), and 701(a) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 342(a)(1), 342(a)(4), and 371(a)), in

conjunction with section 361 of the Public Health Service Act (the PHS

Act) (42 U.S.C. 264). Section 402(a)(1) of the act states that food is

adulterated if it bears or contains any poisonous or deleterious

substance that may render it injurious to health. Section 402(a)(4) of

the act was included in the act to provide additional control over

insanitary and contaminated foods. (H.R. Rept. No. 2139, 75th Cong., 3d

sess. 6 (1938).) Section 701(a) of the act authorizes the agency to

adopt regulations for the efficient enforcement of the act. Section 361

of the PHS Act authorizes the agency to adopt regulations to prevent

the spread of communicable diseases.

The proposed regulations set out those requirements that the agency

tentatively has concluded are the minimum necessary to ensure that, to

the extent possible, the processing and importation of fish and fishery

products will not result in a product that is injurious to health.

These requirements include the establishment of HACCP preventive

controls that take into account the unique characteristics of seafood

products. If a processor or an importer fails to adopt and implement an

HACCP plan that complies with the requirements that FDA is proposing,

or otherwise fails to operate in accordance with these proposed

provisions, it will be preparing, packing, or holding the food under

insanitary conditions under which the food may be rendered injurious to

health. Thus the food will be adulterated under section 402(a)(4) of

the act and subject to regulatory action by FDA. The agency has

reflected this fact in proposed Sec. 123.6(d).

FDA's tentative decision to adopt regulations that require the

implementation of HACCP principles by the seafood industry is grounded

in the statutory objective of preventing food safety and sanitation

problems. Section 402(a)(4) of the act does not require that FDA

demonstrate that food is actually hazardous or contaminated in order to

deem the food adulterated and to exclude it from commerce. Instead,

under section 402(a)(4) of the act, food producers must assure that the

food is not ``prepared, packed, or held under insanitary conditions

whereby it may have been contaminated with filth, or whereby it may

have been rendered injurious to health.'' [emphasis added.]

In enforcing section 402(a)(4) of the act, FDA has considered,

among other things, prevailing industry standards and the technical

state-of-the-art in determining on a case-by-case basis whether the

conditions under which a company is processing or handling food satisfy

section 402(a)(4) of the act. This proposed regulation would codify an

appropriate state-of-the-art means of assuring seafood safety and of

preventing sanitation problems under FDA's authority to promulgate

regulations for the ``efficient enforcement'' of the act (section

701(a) of the act (21 U.S.C. 371(a))).

The factual record that FDA has developed concerning the safety and

sanitation issues posed by seafood illustrates the need for codifying

appropriate preventive methods consistent with the emerging technical

state-of-the-art and explains why FDA's initial focus in implementing

HACCP is on seafood. Proof that any particular process or set of

manufacturing conditions in the production of seafood has in fact

caused injuries or sanitation problems is not, however, a legal

prerequisite to this rule.

The proposed adoption of this rule is supported by several

additional factors. First, as stated above, the application of HACCP to

the seafood industry has been the subject of a substantial amount of

work, by the Federal government, some States, academia, and the seafood

industry itself, to develop specific HACCP models and otherwise to

apply HACCP to seafood processing and importation. The Model Seafood

Surveillance Project (MSSP) was conducted by NOAA at the request of

Congress in 1986 to design an inspection system for seafood consistent

with HACCP principles. This project resulted in the development of 16

regulatory models for specific seafood products that describe the basis

for a mandatory seafood inspection system. Each model applies many of

the NACMCF principles described above in the context of a specific

product, such as breaded shrimp, raw fish, and molluscan shellfish

(Ref. 35, pp. 67 to 73).

The MSSP was conducted with significant industry involvement. The

importance of industry participation in the development of HACCP

systems was stressed by NAS in its 1985 study of HACCP (Ref. 36, pp.

13, 309, and 310). As part of the MSSP project, 49 workshops were

conducted involving 1,200 industry, State, and university participants.

HACCP controls were considered for economic fraud and plant sanitation/

hygiene as well as for safety because economic fraud and sanitation

have been problems in the seafood industry. The MSSP models cover

nearly all the types of seafood products consumed in the United States

except for low acid canned seafood, which is already subject to a

mandatory HACCP control and inspection system under the low acid canned

food regulations adopted by FDA.

Low acid canned seafood products represent about 25 percent of all

seafoods consumed in the United States (Ref. 7, p. 23). The regulatory

system in place for them represents the first formal application of

HACCP principles to food by a regulatory agency. As with this proposal,

the regulations for low acid canned foods were requested by industry,

and they were developed through cooperation between Government and

industry.

Although the low acid canned food regulations apply HACCP concepts

to two hazards only, i.e., botulism in canned foods and contamination

because of poor container integrity, they are regarded as a major

success and demonstrate the benefits that HACCP can provide. Botulism

in canned goods has been effectively controlled under the low acid

canned food regulations and is no longer a particular source of

consumer concern. NAS recently concluded that canned fish is among the

safest of seafood items. (Ref. 7, p. 320).

Seafood industry associations have been active in developing HACCP

systems that their members could use. For the past several years, the

New England Fisheries Development Association (NEFDA) has been

assisting firms in the northeast to implement HACCP systems through

Federal grants. NEFDA's activities include a pilot project for 15

processing firms and participation in a retail seafood HACCP pilot

(Ref. 18, p. 26).

Academia has been active as well. For example, the Oregon Sea

Grant, which services the Oregon marine community as part of the

national Sea Grant extension service, has issued a publication,

``Hazard Analysis & Critical Control Point Applications to the Seafood

Industry'' (Ref. 37). This publication explains the fundamentals of

HACCP, inventories microbial hazards of seafoods, and describes model

HACCP systems for specific types of seafood processing operations.

As a result of efforts like these by Government, industry, and

academia, a considerable amount of literature and expertise now exist

to facilitate the development of HACCP systems by seafood processors

and importers, significantly more than for most other major segments of

the food industry. Given the advanced state of knowledge about the

application of HACCP to the seafood industry, FDA is proposing to make

the use of HACCP mandatory for the seafood industry to ensure that

there is compliance with section 402(a)(1) and 402(a)(4) of the act.

Second, seafood industry representatives have been urging the

Federal Government to adopt a mandatory, HACCP-based system for years.

The National Fisheries Institute, the largest seafood industry trade

association, and others from the seafood industry testified repeatedly

at congressional hearings from 1989 through 1992 in support of

legislation that would mandate such a system.

Indeed, nearly all of the seafood bills introduced in the Congress

since the late 1980's, including the bills that passed both chambers in

1990, contained HACCP elements. While there were different views on the

merits of these legislative proposals, virtually all Government

agencies, both Federal and State, that testified on these proposals--as

well as most other witnesses--expressed support for the HACCP concept

as it applies to seafood. The Chairman of the Interstate Shellfish

Sanitation Conference (ISSC), an organization of States, Federal

agencies, and industry that considers issues relating to molluscan

shellfish safety, testified that a HACCP-type approach is now being

used for aspects of the shellfish program and endorsed HACCP for all

seafood.

Significant elements of the seafood industry continue to press for

the Federal Government to institute a HACCP-based program. An article

in a 1992 edition of a seafood trade publication on the advantages of

HACCP concluded: ``With the seafood industry under a continuing barrage

of negative press regarding the wholesomeness and safety of product,

the industry is impatient to get started with a seafood inspection

program that will reassure consumers * * *'' (Ref. 19, p. 39).

In February, 1993, the Executive Vice President of the National

Fisheries Institute wrote to the Secretary of Health and Human Services

asking that she ``initiate a state-of-the-art program for seafood which

would be of significant benefit to consumers * * *. HACCP-based

regulation is very feasible for the seafood industry * * *. There is no

reason to wait for congressional action to put this modern technology

in place'' (Ref. 38). As recently as April, 1993, the President of the

Pacific Seafood Processors wrote to FDA expressing support for a

mandatory seafood HACCP program (Ref. 39). The members of that

organization process the majority of domestically harvested seafood.

These requests provide further evidence of the appropriateness of this

proposal.

B. Preparing for HACCP

FDA recognizes that this proposal involves a significant departure

from current practices for most processors and importers and intends to

work cooperatively with the industry in the establishment of this

proposed system. The agency's experiences under both its HACCP-based

low acid canned food regulations and the HACCP-based pilot programs for

seafood that it conducted with NOAA in 1991 demonstrate the need for

cooperation and technical support between the agency and the industry

in order to establish HACCP and to make it work.

The FDA/NOAA joint pilot programs involved the development and

implementation of HACCP-based systems by seafood processors and HACCP-

based inspections by the two agencies. Even though the FDA/NOAA pilots

involved highly motivated seafood firms that volunteered to adopt

HACCP, the firms found it difficult initially to identify hazards and

critical control points associated with their own products and

processes (Ref. 40). As both the agencies and the firms discovered,

HACCP involved new ways of thinking and behaving that were not readily

understood or implemented. A considerable amount of consultation and

assistance between the firms and the Government proved to be extremely

helpful.

This experience reinforces the view that regulations that impose a

HACCP-based system are needed for the seafood industry and thus

represents a third factor supporting the appropriateness of this

proposal. The systematic kind of preventive thinking that HACCP

requires is not universal, but it can be adopted. Regulations will

ensure that processors and importers do so. Significantly, once

participants in the pilot programs made the transition to HACCP, they

were able to identify benefits from using HACCP to themselves and to

consumers in terms of product safety and quality, as well as plant

sanitation and organization (Ref. 40).

VI. International Trade

Although not a public health issue, international trade is also a

major consideration in determining the advisability and benefits of a

new system of seafood regulation and therefore will be addressed here.

It is estimated that close to 40 percent of the fish and shellfish

harvested from the world's oceans, lakes, and other bodies of water

entered international trade in 1991 (Ref. 41). This movement reflects

the need to match supplies with demand. Nations often have species in

their waters for which there is little or no demand among their

consumers, while consumers in other countries may prefer these species.

In addition, sometimes foreign markets are willing to pay higher prices

than domestic markets.

Participation in the international trade in seafood is critical to

U.S. consumers and industry. Approximately 55 percent of the U.S.

supply of edible seafood is imported. In 1991, 3,014,819,000 pounds

were imported, worth $5,617,887,000, making the United States the

world's second largest seafood importing nation (Ref. 42).

At the same time, the United States is the world's largest exporter

of fishery products. In 1991, the United States exported more than $3

billion worth of seafood, making a significant positive contribution to

this country's balance of payments as well as to the many coastal State

economies in which these products are produced (Refs. 42 and 43). Our

largest market is Japan, followed by the European Community (EC) and

Canada. Both Canada and the EC have implemented or are in the process

of implementing mandatory HACCP-based seafood inspection systems (Refs.

32 and 44).

Given the significance of both international and domestic trade,

ongoing efforts to harmonize or make equivalent country inspection

systems and requirements takes on great significance. The current

multilateral round of trade negotiations under the General Agreement on

Tariffs and Trade (GATT) has resulted in further focus on this area.

The draft text on sanitary and phytosanitary measures acknowledges the

desire of the contracting parties, including the United States, to

support ``the use of harmonized sanitary and phytosanitary measures

between contracting parties, on the basis of international standards,

guidelines, and recommendations developed by the relevant international

organizations including the Codex Alimentarious Commission * * *''

(Ref. 45, p. L.35). This move toward harmonization, coupled with the

current recommendations of the Codex Committee on Food Hygiene

encouraging the international use of the HACCP system (Ref. 46),

clearly argue for the adoption of this approach in the United States

for seafood. Failure by the United States to adopt a mandatory, HACCP-

based inspection system may ultimately undermine its export success,

with considerable economic consequences. For example, in addition to

the EC, Canada, Iceland, Australia, and many other fishing nations have

moved to a mandatory HACCP approach that could affect United States

competitiveness in the major seafood markets.

The EC is the United States' second largest export market,

purchasing $441 million worth of U.S. products in 1991. On July 22,

1991, EC Council Directive 91/493 was issued to set out the conditions

for the production and placing on the EC market fish and fishery

products (Ref. 44). This Directive requires, as of January 1, 1993,

that both member States and third countries:

* * * take all necessary measures so that, at all stages of the

production of fishery products * * * persons responsible must carry

out their own checks based on the following principles:

--Identification of critical control points in their establishments

on the basis of the manufacturing processes used;

--establishment and implementation of methods for monitoring and

checking such critical control points; * * *

--keeping a written record * * * with a view to submitting them to

the competent authority * * *.

While the directive provides some flexibility in terms of

equivalence, it is clear that the EC is looking for a mandatory HACCP

system along the lines proposed in this regulation. Maintaining and

expanding this export market is likely to be facilitated if this

proposal is adopted.

Similarly, ongoing discussions with Canada under the terms of

section 708 of the U.S./Canada Free Trade Agreement (FTA) to harmonize

or make equivalent the two nations' respective inspection systems and

standards have made it clear that this proposed HACCP regulation will

significantly facilitate the process (Ref. 47). Canada has recently

completed implementation of a mandatory, HACCP-based seafood inspection

program. Because Canada is the United States' third largest export

market and largest supplier of imported seafood, adoption of an

equivalent system would not only achieve the objectives of the FTA but

potentially would save resources currently devoted to monitoring

shipments between our two countries. Similar potential benefits could

be expected under the proposed North American FTA, particularly at this

formative stage in that process. Thus, facilitation of international

trade is a fourth factor supporting the appropriateness, and thus

providing a rational basis, for FDA's proposed course of action.

VII. The Proposed Regulations

These proposed regulations consist of a subpart of general

applicability (subpart A) and one subpart that sets forth specific

additional provisions for raw molluscan shellfish (subpart C). The

agency is also setting forth guidelines, in the form of appendices,

that will provide assistance to processors of cooked, ready-to-eat

products (Appendix A), and to processors of scombrotoxin forming

species (Appendix B), on how to meet various requirements in subpart A

relating to the development and implementation of HACCP plans. The

products addressed in the guidelines involve special considerations or

special hazards for which additional guidance would be useful.

Processors and importers that follow these guidelines will increase the

likelihood that FDA will find their preventive controls acceptable. FDA

requests comments on the need for, and the substance of, the guidelines

that it has set forth. Comments should address whether it would be more

appropriate for FDA to adopt the guidelines as regulations. If the

comments provide a convincing basis for doing so, FDA will include some

or all of the guidelines in the regulations in any final rule that

results from this rulemaking.

FDA is also including a guideline on how to ensure product

integrity relating to economic adulteration (Appendix D). FDA is

including this guideline because economic adulteration is a particular

problem in the seafood industry.

In Appendix 1 to this document, FDA is also providing samples from

a package of general guidance, to be published separately, for

processors to use in understanding and implementing HACCP principles in

their operations. One of these samples is specific guidance on the

processing of smoked and smoke-flavored fish. FDA requests comments on

whether the latter guidance should remain as such, be provided as

guidelines in an appendix to the regulations, or be made mandatory by

incorporating them into any final rule that results from this

proceeding.

A. Definitions

The agency is relying generally on the definitions contained in the

act, in the umbrella good manufacturing practice guidelines in part

110, and in other agency regulations. The agency is using these

definitions because it considers consistency in how it uses terms in

its regulations to be necessary and appropriate. Thus, Sec. 123.3(o) is

derived from Sec. 113.3(s), and Sec. 123.3(r) is derived from

Sec. 110.3(q). Additional definitions are proposed in Sec. 123.3 that

are specific to the proposed HACCP program for fish and fishery

products.

The agency is proposing to define ``certification number'' in

Sec. 123.3(a) as a unique combination of letters and numbers assigned

to a shellfish processor by a shellfish control authority, usually the

State. These numbers are used to identify the processor on tags and

labels and in recordkeeping required under proposed Sec. 123.28. States

issue certification numbers to processors who receive shellfish from

safe sources, keep requisite records of shellfish purchases and sales,

and operate in accordance with CGMP and the other certification

requirements of the State. This system of State issued numbers is used

to identify the approximately 2,000 State certified shellfish dealers

that are included on the Interstate Certified Shellfish Shippers List.

The agency is proposing in Sec. 123.3(b) to define ``cooked, ready-

to-eat fishery product'' as a fishery product that is subjected by a

commercial processor to either a cooking process before being placed in

a final container, or to pasteurization in the final container, or to

both. Cooked, ready-to-eat products undergo a heat treatment by a

processor that results in the coagulation of the protein. Because their

organoleptic qualities suggest that they are fully cooked, and thus

ready-to-eat, these products will likely be eaten without any further

heat treatment by the consumer sufficient to eliminate pathogenic

microorganisms and preformed toxins.

As defined, cooked, ready-to-eat fishery products include products

that must be stored either frozen or refrigerated. Products such as

canned seafoods that are subjected to a cooking process after being

placed in a final container, while technically considered cooked,

ready-to-eat products, are not included in the definition because they

are virtually sterile in the final container. As used in these proposed

regulations, the term applies to cooked, ready-to-eat products that do

not receive a heat treatment in the final container by the processor

sufficient to destroy all pathogens and create a shelf-stable product

that does not need refrigeration.

The agency is proposing in Sec. 123.3(c) to define ``critical

control point'' for purposes of these regulations as a point in a food

process where there is a high probability that improper control may

cause, allow, or contribute to a hazard in the final food. This is a

modification of the definition of the same term in Sec. 110.3(e). Under

that definition, a ``critical control point'' is a point where an

improper control could cause, allow, or contribute to ``filth in the

final food or decomposition in the final food'' as well as to a

``hazard'' in the final food. Clearly, that definition is intended to

apply both to human food safety and to certain quality issues that

would not normally cause illness. In this document, FDA is proposing to

require the identification of critical control points for safety only

and is encouraging, but not requiring, the identification of certain

critical control points for hazards not normally related to safety. The

modification of the part 110 definition being proposed here represents

the least revision necessary to achieve that purpose.

The agency is proposing to define ``critical limit'' in

Sec. 123.3(d) as a maximum or minimum value to which a physical,

biological, or chemical parameter must be controlled at a critical

control point to minimize the risk of occurrence of the identified

hazard. This definition is consistent with that of NACMCF, which

defined ``critical limit'' as ``a criterion that must be met for each

preventive measure associated with a critical control point'' (Ref. 34,

p. 186), but FDA's proposed definition is somewhat more explanatory.

Critical limits can be either maximum values, such as the maximum

amount of histamine that can be allowed in a fish, or minimum values,

such as the minimum temperature needed during a cooking step to kill

pathogens.

The proposed definition states that control is for the purpose of

minimizing risk. While complete prevention of a hazard is obviously the

most desirable of all possible outcomes, the proposed definition

recognizes that, in reality, complete prevention cannot always be

ensured. A processor can minimize a microbiological hazard with a

cooked, ready-to-eat product by proper cooking, but the hazard could

still occur if the product is contaminated or otherwise abused

elsewhere in the distribution system or in the home. This aspect of the

definition is consistent with the view of NACMCF, which states that:

``Each CCP [critical control point] will have one or more preventive

measures that must be properly controlled to assure prevention,

elimination or reduction of hazards to acceptable levels'' (Ref. 34, p.

196).

The agency is proposing in Sec. 123.3(e) to define ``fish'' and

broadly to encompass the range of seafood products that are processed

or marketed commercially in the United States. Thus, the term ``fish''

includes all fresh or saltwater finfish, molluscan shellfish,

crustaceans, and other forms of aquatic animal life. Birds are

specifically excluded from the definition because commercial species of

birds are either nonaquatic or, as in the case of aquatic birds such as

ducks, regulated by USDA. Mammals are also specifically excluded

because no aquatic mammals are processed or marketed commercially in

this country.

``Fishery products'' in proposed Sec. 123.3(f) are any edible human

food product derived in whole or in part from fish, including fish that

has been processed in any manner. This definition reflects the

tentative conclusion of the agency to propose mandatory HACCP

requirements at this time to control hazards associated with processing

and importing seafood products intended for human consumption. The

proposed definition includes products that contain ingredients other

than seafood in keeping with the scope of FDA's regulatory authority.

The control of hazards is as important for products that contain

ingredients other than fish as it is for products consisting of fish

alone.

The agency is proposing in Sec. 123.3(g) to define ``harvester'' as

a person who commercially takes molluscan shellfish from their growing

waters, by any means. Harvester is defined because, under this

proposal, this person has responsibility for tagging the product as to

where it was harvested and when. Harvesters are expected to have an

identification number issued by a shellfish control authority.

Harvesting is generally illegal without such a number.

The agency is proposing to define the term ``importer'' in

Sec. 123.3(h) as the owner of the imported goods or his representative

in the United States. This is the person who is responsible for

ensuring goods being entered are in compliance with all laws affecting

the importation. Importers may not always directly handle the imported

food, but they are responsible for the safety and wholesomeness of

products they offer for entry into the United States and therefore are

subject to part 123.

The agency recognizes that the term ``importer'' is often used to

describe not only the owner of the goods or his representative in the

United States (that is, the importer of record) but also includes

freight forwarders, food brokers, food jobbers, carriers, and steamship

representatives. These other agents often represent the importer for

legal and financial purposes that are not necessarily related to the

safety of the product. Therefore, the agency has tentatively concluded

that it is inappropriate to focus the HACCP requirements that bear on

imports on these persons if they do not have authority to make

decisions affecting the product's safety or wholesomeness.

FDA is proposing to define a ``lot of molluscan shellfish'' in

Sec. 123.3(i) as no more than one day's harvest from a single, defined

growing area, by one or more harvesters. This definition establishes

the quantity of shellfish that represents a single lot for tagging or

labeling purposes. Lot distinctions are needed to differentiate

shellfish harvested from different growing areas or at different times.

The time limit of one day is imposed because the safety of a harvesting

area can change daily as the result of rainfall, tides, winds, and

other events that can bring contaminants into the area. The ultimate

safety of raw molluscan shellfish is contingent on the water quality of

the harvesting area. To ensure product safety, shellfish harvesting

areas that are subject to appropriate state control are closed to

harvesting within 24 hours of a finding of adverse conditions. The lot

definition, coupled with the harvest date on the harvesting tag,

provides evidence that the shellfish were harvested when the area was

safe and open for harvesting.

The agency is proposing in Sec. 123.3(j) that ``molluscan

shellfish'' means any edible species, or edible portion of fresh or

frozen oysters, clams, mussels, and scallops, except were the scallop

product consists entirely of the shucked adductor mussel. The

distinction between molluscan shellfish and crustacean shellfish, which

include crabs, shrimp, and lobsters, is made because molluscan

shellfish are commonly eaten whole and raw, while crustacean shellfish

are not. The safety of molluscan shellfish therefore reflects the

quality of the waters from which they are harvested and requires

special public health controls. Furthermore, the agency is proposing to

amend the definition of ``shellfish'' in Sec. 1240.3(p) (21 CFR

1240.3(p)) to make it consistent with the proposed definition in

Sec. 123.3(j). The agency is proposing to amend the term ``shellfish''

in Sec. 1240.3(p) to read ``molluscan shellfish'' to make the terms

consistent between parts 123 and 1240. Because the term shellfish in

its common usage, i.e., an edible mollusk or crustacean, includes crabs

and lobsters, the agency believes that it is necessary to be more

specific and accurate in its definition and consequent application of

the requirements in its regulations. The proposed requirements for

tagging do not apply to crabs and lobsters or to scallops when the

final product is the shucked adductor muscle only. The agency is

proposing to expand the definition in Sec. 1240.3(p) to include

scallops to make it consistent with the definitions in proposed part

123 and with requirements under NSSP.

The agency is proposing to define ``potable water'' in

Sec. 123.3(k) as water that meets EPA's primary drinking water

regulations as set forth in 40 CFR part 141. Those regulations provide

limits for certain microbiological, chemical, physical, and

radiological contaminants that can render water unsafe for human

consumption.

The proposed definition is slightly different from the definition

of ``potable water'' in Secs. 1240.3(k) and 1250.3(j) (21 CFR

1250.3(j). That definition also references the regulations of EPA in 40

CFR part 141 but further includes FDA sanitation requirements in 21 CFR

parts 1240 and 1250. Those sanitation requirements apply to interstate

travel conveyances that must take on water at watering points. Such

requirements are not relevant to these proposed regulations and thus

were not included in the proposed definition.

FDA is proposing to define ``processing'' and ``processor'' in

Sec. 123.3(m) and (n) broadly to ensure the safety of seafood through

the application of HACCP principles throughout the seafood industry.

The definition of ``processor'' is intended to include all seafood

processors that handle products in interstate commerce, such as

shuckers and other processors of raw molluscan shellfish, factory

ships, packers, repackers, wholesalers, and warehouses. Those who

process low acid canned foods are also included, even though they are

subject to the HACCP controls of part 113. Those controls are targeted

toward a limited number of safety hazards. These proposed regulations

require that processors apply HACCP controls to all likely safety

hazards.

Consistent with the regulations at part 113, the proposed

definition of ``processor'' also includes persons engaged in the

production of foods that are to be used in market or consumer tests.

FDA has tentatively concluded that HACCP controls are needed for such

products because the hazards associated with them are no different from

those that can affect other commercial products.

There are, however, certain handlers of seafood that are not

included in the coverage of the proposed definition. Fishing vessels

that essentially only harvest are not covered by the proposed HACCP

regulations. As explained earlier, FDA has traditionally refrained from

directly regulating fishing vessels. The agency anticipates that the

regulations being proposed here would affect vessels indirectly through

processor and importer controls over raw materials and imported

shipments, e.g., preventive controls such as the purchasing of raw

materials only from fishing vessels that engage in proper sanitation

and time/temperature practices and that harvest only from approved

areas.

Transportation companies that carry, but do not otherwise process,

fish and fishery products are also outside the scope of the proposed

definition, although the agency expects that transporters will be

affected indirectly in the same manner as fishing vessels (see also

Sec. 110.93). FDA invites comment on this aspect of the coverage of the

proposed regulations. Proper refrigeration during transport is

important for the safety of scombroid species products and of cooked,

ready-to-eat products. Time and temperature conditions during shipment

can also affect decomposition related to other factors bearing on

seafood quality. These proposed regulations will affect transportation

companies indirectly through the preventive controls the processor or

importer will need to impose to ensure that the raw materials or

imported shipments that it receives are free of relevant hazards and

have been appropriately handled. FDA invites public discussion on

whether this approach is adequate, and, if not, whether HACCP

requirements should be applied directly to transportation companies.

This issue is complex, especially because it is not unusual for

transporters to deliver a variety of food products, including seafood,

to several consignees during a single shipment.

The agency has also tentatively decided to exclude retail

establishments from the definition of ``processor.'' As with fishing

vessels, FDA has traditionally exercised enforcement discretion with

regard to retail establishments. The number of retail establishments in

this country--literally in the hundreds of thousands--would totally

overwhelm any rational Federal inspection system. FDA has traditionally

provided training and other forms of technical assistance to States and

local governments to inspect retail food establishments through the

agency's retail Federal/State cooperative program. A major part of that

cooperative program involves the development of model codes, some of

which have been widely adopted by State and local governments. FDA is

now consolidating those model codes into a single, updated food code

for the retail sector. Appropriate HACCP-based controls are included to

address seafood hazards at retail. Consequently, FDA will continue to

operate through the Federal/State cooperative mechanism and has not

included a retail component in proposed part 123. FDA requests comments

on this tentative approach.

States are strongly encouraged, however, to consider how the

principles in these regulations could be applied to seafood at retail

and to shift to HACCP-type inspection systems as appropriate. Because

of the high perishability of fresh seafood and the sometimes lengthy

and complex distribution chain, these products can have relatively

short shelf lives by the time they reach fresh fish counters and

restaurants. In addition, seafood can be subject at retail both to

cross-contamination because of poor handling practices and to species

substitution.

Improper handling of seafood and other problems at retail have been

documented in recent years. NAS has concluded that a significant number

of reported acute health problems were likely linked to handling and

preparation practices in food service establishments (Ref. 7, p. 27).

The February, 1992 edition of Consumer Reports magazine reported on a

number of such problems with regard to seafood that were observed in

retail establishments. A number of studies have found lack of adequate

temperature controls in retail facilities (Ref. 48, p. 75).

The agency is proposing to define ``shellfish control authority''

in Sec. 123.3(p) as the government entity responsible for implementing

a comprehensive shellfish sanitation program. The shellfish control

authority, among other things, is responsible for classifying shellfish

growing waters, performing inspections of shellfish processors, and

issuing certification numbers to shellfish processors. FDA relies on

recognized governmental public health and food control agencies, both

domestic and foreign, to carry out these functions.

The agency is proposing to define ``shellstock'' in Sec. 123.3(q)

as meaning raw, in-shell molluscan shellfish. This specific product

form designation is needed because the applicability of the tagging,

labeling, and recordkeeping requirements proposed in Sec. 123.28(b) and

(c) is determined by whether the product is shellstock or shucked

product, respectively.

The agency is proposing to define ``shucked shellfish'' in

Sec. 123.3(s) as meaning molluscan shellfish that have one or both

shells removed. The labeling and recordkeeping requirements proposed in

Sec. 123.28(c) apply to shucked shellfish.

The agency is proposing to define ``tag'' in Sec. 123.3(t) as a

record of harvesting information attached to a container of shellstock

by the harvester or processor. Under proposed Sec. 1240.60(b), the tag

or bill-of-lading will identify the processor, harvester, date of

harvest, and State, including the specific location of harvest. Most

shellfish-producing States and countries currently require that

shellfish harvested in their waters bear documentation with such

information. This information is the minimum necessary to permit ready

identification of site and time of harvest of the shellfish. Because

raw molluscan shellfish directly reflect the quality of the harvesting

area, this information is necessary to provide assurance that the

shellfish were harvested from an area that was safe and open for

harvesting.

B. Purpose and Criteria

Section 123.5(a) of the proposed regulations references the

umbrella CGMP guidelines in part 110 as providing general guidance with

regard to such matters as facility design, materials, personnel

practices, and cleaning and sanitation procedures. Because part 110

provides guidance of general applicability to all foods, the agency

intends that this guidance will continue to be valid for seafood

processors when the proposed regulations at part 123 are issued in

final form. Proposed Sec. 123.5(b) makes clear that the purpose of

subpart A of part 123 is to set forth requirements specific to the

processing and importation of fish and fishery products.

C. HACCP Plans

1. Summary

FDA is proposing to require in Sec. 123.6 that commercial

processors and importers of fish and fishery products develop and

implement HACCP plans in keeping with Principle 6 of the NACMCF

discussed previously. Development and implementation of an HACCP plan

requires that processors think through the entire process flow from raw

materials to finished product shipping to ensure that safety hazards

are controlled by design, and that they operate that process as a

matter of daily routine. For importers, the thought process will begin

with a decision from whom and from where to buy fishery products and

follow through to arrangements for shipment to the United States,

storage in the United States, and end when the product leaves the

control of the importer. The plan provides the structure for the

preventive controls, including the recordkeeping associated with those

controls, that a processor or importer is to employ.

In summary, FDA has tentatively concluded that the essential

elements of this structure must include: (1) The identification of

hazards to ensure that the processor or importer knows what the hazards

are, so that it controls them by design rather than by chance (proposed

Sec. 123.6(b)(1)); (2) the identification of critical control points to

ensure that the processor or importer knows where to monitor to prevent

or minimize the occurrence of the relevant hazard (proposed

Sec. 123.6(b)(2)); (3) the identification of critical limits that must

be met at each critical control point, so that the processor or

importer has objective standards in place by which to determine whether

it is controlling the relevant hazard (proposed Sec. 123.6(b)(3)); (4)

the identification of procedures for how and when the processor or

importer will monitor the critical control points to ensure both that

monitoring is done as a matter of routine, and that it is done in an

appropriate manner and with sufficient frequency to establish

preventive control (proposed Sec. 123.6(b)(4)); and (5) a recordkeeping

system for that monitoring that will establish for the processor's or

importer's benefit that it is effectively implementing a system of

preventive controls, and record how those controls are operating over

time (proposed Sec. 123.6(b)(5)).

The recordkeeping system is the key to HACCP. As explained above,

the records will enable the processor or importer, and ultimately the

regulator, to see the operations of the processor or importer through

time, rather than only how they are functioning at a particular moment

in time. Among other things, HACCP records can reveal trends that might

otherwise go undetected until significant problems occurred.

All of these requirements reflect the HACCP principles developed by

NACMCF.

FDA is not proposing to require that the HACCP plan be signed by

any official of a company, but invites comment on the merits of such a

requirement in the final regulations as a means of both ensuring and

demonstrating formal adoption of the plan by that company. FDA also

invites comment on who in the firm would be the appropriate individual

to sign the plan.

2. Guidelines and Other Assistance

FDA recognizes that HACCP plans will vary in complexity, from those

having many critical control points, such as plans for multicomponent,

ready-to-eat products, to those having only a few critical control

points, such as a plan for a fish filleting plant. Plan development can

be facilitated by technical assistance from many sources and by the

detailed advice provided in the literature. NACMCF, for example, has

recommended that, to facilitate the development of HACCP plans,

processors should create an HACCP team, identify the intended use and

likely consumers of the food, and prepare a flow diagram of the entire

manufacturing process to help identify critical control points.

The agency favors simplicity and the rapid development of HACCP

plans without undue expense. The appendices at the end of the proposed

regulations are intended to facilitate plan development by setting

forth certain critical control points, critical limits, controls, and

records that, if incorporated into or prepared under a HACCP plan,

would be acceptable to the agency for the types of products mentioned.

To further facilitate the development of HACCP plans, FDA intends to

issue separate HACCP guidance for seafood that will provide information

on hazards and appropriate controls by species and by product type.

The guidance will provide a broad spectrum of information from

which firms will be able to identify likely hazards and critical

control points that apply to them. The agency believes that the number

of critical control points will range, roughly, between 2 and 12 per

product.

The guidance will also contain a fill-in-the-blank type of HACCP

plan with instructions on how to complete the plan based on information

in the guidance. The agency has tentatively concluded that a plan that

follows this model is likely to be acceptable to FDA. The agency is

including samples of the guidance it is developing in Appendix 1 to

this document. FDA intends to issue a separate draft guidance document

for public comment and to make the completed guidance available to the

public at the time that the regulations are finalized.

In addition, seafood trade associations, university Sea Grant

extension offices, and others have already developed work sheets and

other aids to facilitate HACCP planning for seafood. Industry members

are encouraged to contact their trade associations and state

universities or Sea Grant extension offices on such matters.

3. Effective Date

Even with these forms of assistance, however, FDA recognizes that

HACCP plans cannot be written and implemented overnight. As has already

been discussed, the HACCP system of controls can involve new ways of

thinking and performing on a routine basis. Consequently, FDA is

proposing that these regulations will become effective 1 year after

issuance of the final rule in this proceeding. The agency has

tentatively concluded that this period of time is sufficient to permit

the development and implementation of HACCP plans by the industry. FDA

specifically invites comment on whether 1 year will be adequate. The

agency's objective is to provide enough time to permit processors and

importers to understand HACCP, analyze the relevant hazards, and

develop an appropriate HACCP plan, but also to avoid unnecessary delay.

After the proposed effective date, inspection of HACCP plans will

occur as part of routine, mandatory plant inspections and import

examinations. FDA is not proposing to require that HACCP plans be

submitted to FDA in advance, or that preapproval by FDA be a condition

of their adoption or implementation. FDA is not requiring preapproval

for two reasons. First, HACCP plans can only properly be judged in the

context of the facility itself. Thus, while FDA investigators will

consider the adequacy of the plan during their inspections, preapproval

does not seem warranted. Second, the agency simply does not have the

resources to make preapproval a requirement. Given the protections that

are built into the HACCP approach, FDA tentatively finds that

preapproval is not necessary to ensure that fish and fishery products

are not produced under conditions whereby they may be adulterated under

section 402(a)(4) of the act.

4. Location and Product Type

FDA is proposing in Sec. 123.6(a) to require that every processor

and importer have and implement an HACCP plan that is specific both to

each location where that processor engages in processing and to each

kind of fish and fishery product being processed. A plan should be

specific to each location because the likely hazards, critical control

points, critical limits, and monitoring procedures can vary from one

facility to the next depending on such factors as type of equipment,

conditions and procedures, and location. A plan also should be specific

to each type of fish and fishery product for the same kinds of reasons.

Hazards can vary depending on species, location of catch, and other

factors.

FDA does not intend, however, to require a processor or importer to

write a separate plan, or separate part of a plan, for each fish and

fishery product it handles if the likely hazards, critical control

points, critical limits, and monitoring procedures are identical for

each of them. For example, the preventive controls necessary to ensure

safety for most deep water species of finfish from the north Atlantic

may be virtually identical. The agency has tentatively concluded that,

in such cases, a processor or importer may group the fish or fish

products together in an HACCP plan.

5. Safety Hazards Only

FDA is proposing to require at Sec. 123.6(b)(1) that HACCP plans

identify the human food safety hazards that must be controlled for each

fish and fishery product being processed by a processor or importer.

There exists a range of opinion on whether HACCP should apply solely to

safety hazards, as this provision proposes to require, or whether HACCP

should apply to other types of hazards, such as decomposition not

normally associated with illness in humans. One school of thought holds

that HACCP should apply to safety hazards only in order to keep it

focused and to not overwhelm operators with an unnecessarily large

number of critical control points that have no bearing on the primary

concern of safety. Another view holds that, for seafood at least,

HACCP-type controls can be applied to various consumer risks without

generating an excessive number of critical control points. The Codex

Committee on Food Hygiene came to the latter conclusion (Ref. 46), as

did NOAA as a result of its experiences during the MSSP (Ref. 35, p.

70). Partly for that reason, the FDA/NOAA HACCP pilot programs involved

HACCP controls for safety and HACCP-type controls for other hazards as

well.

For purposes of these proposed regulations, however, FDA's

application of HACCP is intended for the efficient enforcement of

section 402(a)(1) and 402(a)(4) of the act, which applies to products

that contain substances that may render the product injurious to health

and to processing conditions that are insanitary and that could render

a product injurious to health. Consequently, FDA is proposing to

require that HACCP plans include identification of hazards that could

affect human food safety only. To facilitate the production of such

plans, FDA has listed in proposed Sec. 123.6(b)(1) the types of hazards

that have been associated with seafood (see section II.C. of this

document for a discussion of these hazards). All of these hazards are

identified and discussed in the NAS report on seafood safety (Ref. 7).

Processors and importers should identify in their written plans

only those safety hazards that are reasonably likely to occur, rather

than every conceivable hazard no matter how theoretical or remote. This

view is in keeping with NACMCF's recommendation that firms conduct a

hazard analysis and then give no further consideration to hazards that

are unlikely to occur (Ref. 34, p. 189). FDA has tentatively concluded

that processors and importers should not be required to establish

controls and regularly monitor for hazards that are highly unlikely to

occur in the absence of those controls. If, for example, chemical

contaminants have never been found, or have only been found in amounts

significantly below levels of public health concern in a species from a

particular location, processors and importers need not identify

chemical contaminants as a hazard that must be controlled for that

fish.

As indicated earlier in this preamble, FDA intends to issue a

guidance document that will cover possible environmental and processing

hazards for fish and fishery products as well as types of controls that

can be applied to those hazards. The agency anticipates that it will

update that guidance periodically as new controls (or new hazards) are

identified or established.

FDA cannot reasonably expect processors and importers to exercise

controls for hazards that are beyond the scope of current scientific

knowledge. The agency does expect processors and importers to

demonstrate that they are taking precautions that are reasonable in

light of available information, and that they are adopting new controls

as those controls are developed and accepted.

For example, the controls for Vibrio bacteria in raw molluscan

shellfish, which can cause serious illness and death in certain at-risk

populations, are the subject of continuing research at FDA and

elsewhere. Short of a complete ban on harvesting, there is no known

control that would prevent the presence of Vibrios in molluscan

shellfish. Moreover, the infectious dose, that is, the number of

Vibrios necessary to cause illness, is unknown. Because these bacteria

occur naturally in the environment and are ubiquitous, controls that

are employed to prevent sewage-related viruses from entering molluscan

shellfish are not relevant to Vibrios. It is known, however, that

proper temperature controls from the time of harvest onward can at

least limit the growth of these bacteria (Ref. 49). FDA believes that

such controls are reasonable and should be applied now. (In fact,

temperature controls have long been a feature of the National Shellfish

Sanitation Program (NSSP).)

Of the hazards listed in proposed Sec. 123.6(b), pesticides and

drug residues (proposed Sec. 123.6(b)(1)(iv) and (b)(1)(v)) are forms

of chemical contaminants (proposed Sec. 123.6(b)(1)(iii)) but are

listed separately because they can be of special concern in

aquaculture-raised species. These fish generally have a greater

likelihood of being exposed to agricultural run-off than wild ocean

stocks (Ref. 50, pp. 11 and 12). Aquaculture-raised fish are known to

be fed drugs for various purposes. Drug residues in edible tissues can

be a public health concern.

Decomposition, listed in proposed Sec. 123.6(b)(1)(vi), is a known

hazard in those species that can generate scombrotoxin when they

decompose; otherwise, it is regarded as a quality problem. Parasites

(proposed Sec. 123.6(b)(1)(vii)) are not a hazard if killed during

cooking but can be a hazard in finfish consumed raw, unless that fish

is commercially frozen. Unapproved direct and indirect food and color

additives (proposed Sec. 123.6(b)(1)(viii)) are a potential hazard with

most any food.

6. Critical Control Points

Consistent with the HACCP principles identified by NACMCF, FDA is

proposing to require in Sec. 123.6(b)(2) that critical control points

be identified for each of the hazards that the processor or importer

has identified. Hazards may be caused by improper processing or by

events outside the processor's or importer's direct control. To control

the latter type of hazard, that is, environmental hazards and hazards

that may be caused by poor handling prior to receipt of fish or fishery

products by the processor or importer, the point of receipt by the

processor or importer represents a critical control point. As indicated

previously in this preamble, the processor or importer may need to

ensure that it obtains imported shipments or raw materials only from

harvesters, transporters, and others who can demonstrate that they also

have exercised appropriate controls. The hazards that may be caused by

both improper processing and events outside the plant are controlled by

the critical limits, monitoring, control procedures, and recordkeeping

that are done as part of HACCP.

7. Critical Limits

In Sec. 123.6(b)(3), consistent with NACMCF principles, FDA is

proposing that processors and importers identify critical limits in the

plan that must be met at each critical control point. Critical limits

must be met to ensure that the relevant hazard is avoided. Thus, some

critical limits can be set to reflect regulatory levels established by

FDA in the form of action levels, regulatory limits, and tolerances for

such contaminants as pesticides, histamine, and other contaminants. FDA

intends to compile all such levels in the guidance document described

earlier.

Other critical limits can be set in consultation with outside

experts, in keeping with the longstanding practice for low acid canned

foods. For example, as explained later in this preamble with respect to

cooked, ready-to-eat products, there exist a range of possible cooking

time-temperature combinations that will deactivate pathogens during the

cooking step, depending on the type of equipment being used by the

processor and the size and species of fish being cooked. The existence

of a range of effective cooking time-temperature combinations convinced

FDA not to establish specific cooking time-temperatures for industry in

the regulations for low acid canned foods. Rather, FDA decided to rely

on outside experts and on research within the scientific community to

establish cooking times and temperatures for these products. FDA is not

proposing specific cooking time-temperature requirements for most

seafood products (although FDA is providing guidance on time,

temperature, and salinity parameters for smoked and smoke-flavored

fish, as is fully explained in Appendix 1 to this document) for the

same reason.

8. Monitoring and Control Procedures

Proposed Sec. 123.6(b)(4) requires that the processor or importer

identify in the HACCP plan the procedures that it will use to control

and monitor each critical control point. Monitoring steps are necessary

to ensure that the critical control point is in fact under control and

to produce an accurate record of what has occurred at the critical

control point (Ref. 34, p. 197). Among the procedures that are to be

used under proposed Sec. 123.6(b)(4) is monitoring of the consumer

complaints received by the processor. While the goal of an HACCP system

is to prevent all likely hazards from occurring, no system is

foolproof. Consumer complaints may be the first alert that a processor

has that deviations are occurring that are not being prevented or

uncovered by the processor's HACCP controls. FDA has tentatively

concluded, therefore, that each HACCP system should take advantage of

consumer complaints as they relate to the operation of critical control

points.

Proposed Sec. 123.6(b)(4) also requires that procedures for

controlling and monitoring critical control points must include

calibration of process control instruments and validation of software

for computer control systems, as appropriate. For a processor's

preventive controls to work, the instruments and equipment that it

relies upon in monitoring critical control points, such as

thermometers, temperature-recording devices, and computer software,

must be accurate and reliable. FDA has tentatively concluded that the

best way to ensure such accuracy and reliability is to require that the

processor's monitoring procedures include steps necessary to verify the

reliability of these instruments and devices.

9. Recordkeeping

As explained above, a HACCP system will not work unless records are

generated during the operation of the HACCP plan, and these records are

maintained and are available for review (see section IV.A.6. of this

document). Thus, FDA is requiring in proposed Sec. 123.6(b)(5) that the

HACCP plan provide for a recordkeeping system that will document the

processor's or importer's monitoring of the critical control points.

Proposed Sec. 123.6(b)(5) also requires that HACCP records contain the

actual values obtained during monitoring, such as the actual

temperatures and times. FDA has tentatively concluded that it is not

possible for the processor to derive the full benefits of its HACCP

system, nor is it possible for FDA to verify the operation of the

system, without actual values. Notations that refrigeration

temperatures are satisfactory or unsatisfactory, without recording the

actual temperatures, are vague and subject to varying interpretation

and thus will not ensure that preventive controls are working. Also, it

is not possible to discern trends without actual values.

In addition, proposed Sec. 123.6(b)(5) requires that HACCP records

include the actual consumer complaints that may have been received by

the processor or importer relating to the operation of critical control

points or possible critical limit deviations. FDA has tentatively

concluded that it may be necessary on occasion for it to review these

complaints in order to be able to validate whether the firm is taking

necessary steps to review controls and correct deviations as necessary

in response to consumer complaints.

It is not FDA's intent to gain unlimited access to industry's

consumer complaint files through this proposal or to engage in

``fishing expeditions'' through consumer complaint files. Only those

consumer complaints relating to the operation of the HACCP critical

control points need be included as HACCP records. FDA's interest is

solely in verifying that the HACCP system is working as it should. The

agency understands the sensitivities associated with consumer complaint

records and invites comments on this aspect of the proposal.

10. Nonsafety Hazards

Proposed Sec. 123.6(c) encourages, but does not require, processors

and importers to include in their plans controls for hazards other than

hazards to health. Examples listed in Sec. 123.6(c)(1)(i) and (ii) are

decomposition not associated with human illness and economic

adulteration. FDA is not requiring processors and importers to include

nonsafety hazards in their HACCP plans for reasons stated previously.

However, the agency is encouraging processors and importers to apply

HACCP principles to these nonsafety hazards, and to control them in the

same manner that processors and importers control safety hazards (see

proposed Sec. 123.6(c)(2)), because they are common problems in the

seafood industry. FDA has included a guideline on economic adulteration

with these proposed regulations (see Appendix D).

Despite the fact that these proposed regulations do not require

HACCP controls for nonsafety hazards, such hazards as economic

adulteration, decomposition not normally associated with human illness,

general unfitness for food, and misbranding, constitute violations of

the act and are subject to regulatory action by FDA (see sections

402(a)(3) and 403 of the act (21 U.S.C. 343). Inspections by FDA

investigators will continue to consider and enforce these provisions of

the act.

D. Corrective Actions

FDA is proposing in Sec. 123.7 to require that deviations from

critical limits trigger a prescribed series of actions by a processor

or importer, including determining the significance of the deviation,

taking appropriate remedial action, and documenting the actions taken.

This proposed provision is consistent with the HACCP principles

enunciated by NACMCF (Ref. 34). First, under proposed Sec. 123.7(a)(1),

any critical limit deviation will require the segregation and holding

of the affected product until the significance of the deviation can be

determined. This step is necessary to ensure that products that may be

injurious to health do not enter commerce until the impact of the

deviation on safety has been determined, and the safety of the product

assured. Second, under proposed Sec. 123.7(a)(2), the processor or

importer must actually determine the effect of the deviation on safety,

and third, under proposed Sec. 123.7(a)(3), it must take whatever

corrective actions are necessary with respect to both the affected

product and the critical control point at which the deviation occurred,

based on that determination.

Some deviations, especially if they are caught quickly, will not

adversely affect safety. For example, if a refrigeration unit fails,

but product being stored there is moved to a functioning unit before

any appreciable warming of the product can occur, safety will not have

been affected.

FDA is proposing to require in Sec. 123.7(a)(2) that the safety

determination be made by an individual who has successfully completed

training in HACCP principles (see proposed Sec. 123.9). FDA has

tentatively concluded that this requirement is necessary to ensure that

the person who is reviewing the significance of the deviation

understands the possible consequences of a processing deviation and

knows how to take appropriate measures in response to a deviation. FDA

does not expect that a processor or importer will be able, without

assistance, to determine the public health consequences of every

possible deviation. The required training will, however, provide the

processor or importer with information about when and how to obtain the

assistance of an analytical laboratory, outside expert, State

regulatory authority, or FDA district office in determining the proper

course of action.

FDA is proposing to require in Sec. 123.7(a)(4) and (a)(5) that the

processor or importer review the process and the HACCP plan to

determine whether the deviation reveals the need to modify the process

or the plan, or both, and to make such modifications as may be needed.

It is critically important that a processor or importer learn as much

as possible from the occurrence of a deviation and take steps to ensure

that it will not be repeated. The plan should be a living document that

the processor or importer should modify and update as circumstances

warrant. These proposed requirements will ensure that the processor and

importer connect day-to-day processing and other operations to the

plan. Each modification is required to be noted, dated, and maintained

as part of their HACCP records.

FDA is proposing to require in Sec. 123.7(b) that when a processor

or importer receives a consumer complaint that may be related to the

performance of a critical control point or that may reflect a critical

limit deviation, it take appropriate steps to determine whether a

deviation or other system failure has occurred that warrants remedial

action and take such remedial action that appears to be warranted under

Sec. 123.7(a). The importance of consumer complaints has been discussed

above.

FDA recognizes that segregation and holding of the affected product

will not always be feasible or warranted in response to a consumer

complaint. In many cases, there will be no product to hold because all

of the product in question will already be in commerce. In other cases,

a processor or importer may be able to determine very quickly whether a

deviation has actually occurred.

FDA is proposing in Sec. 123.7(c) to require that processors and

importers clearly document all of the steps that they take in response

to a critical limit deviation or a consumer complaint and include that

documentation as part of their HACCP records. FDA has tentatively

concluded that the processor, the importer, and FDA will benefit from

this requirement. Documentation helps processors and importers to think

the whole process through in a thorough and methodical way and to

establish to their own satisfaction that they have taken proper steps.

Documentation enables the regulatory agency to determine whether the

processor or importer is able to regain control once a deviation occurs

and to ensure that potentially unsafe products are being prevented from

entering commerce or at least quickly removed from commerce.

The documentation that FDA is proposing to require of the

processor's or importer's response to the consumer complaints covered

by Sec. 123.7(b) will enable the processor, the importer, and FDA

reviewers to determine whether those consumer complaints are receiving

appropriate attention in a timely manner. The documentation should be

clear enough to allow a determination of the nature of the complaint

and of the time it took from the receipt of the complaint for processor

or importer to review it and to take any necessary corrective actions.

FDA may choose on occasion to review a limited number of consumer

complaints to match against the documentation maintained by the

processor or the importer.

There is a strong view in the HACCP literature (see e.g., Ref. 51),

which is reflected in one of NACMCF's seven principles listed above,

that processors should actually have a plan describing how they will

handle deviations, and that this plan should be part of the overall

HACCP plan. FDA believes that there is merit in this view and

encourages processors and importers to think through how they will

handle deviations that may occur. The agency has tentatively concluded,

however, that the proposed requirements in Sec. 123.7 represent the

minimum requirements necessary to ensure that processors and importers

respond effectively to deviations that could affect safety, and that

given these provisions, it is not necessary to require that a specific

plan be formulated and adopted. FDA requests comments on this tentative

conclusion.

E. Records

As discussed above, maintenance of appropriate records is

fundamental to the success of an HACCP system (see section IV.A.6. of

this document). In recognition of this fact, FDA is proposing to

require in Sec. 123.8 that HACCP records contain certain necessary

information; that processors review records of monitoring and related

activities before distributing the products to which the records

pertain; that processors and importers retain records for specific

periods of time; and that FDA investigators be given access to HACCP

records.

FDA is proposing in Sec. 123.8(a) that records involving

observations or measurements during processing, corrective actions, and

related activities, contain the identity of the product, product code,

and date that the record was made. The purpose of this provision is to

ensure that both the processor or importer and the regulator can

readily link a record to a product and to the timeframe in which the

product was manufactured. The linkage of the record to product is

especially important when there has been a deviation at a critical

control point. The agency has tentatively concluded that including the

identity of the product, product code, and date of the activity that

the record reflects provide the minimum necessary information to enable

the processor or the importer and, ultimately, the regulator to

determine what product may have been affected and to take appropriate

action, such as withholding the product from distribution or recalling

it from distribution. Dates also help discern trends over time. Even

when no deviation has occurred, the information will enable both the

processor and the regulator to identify factors that may help prevent

problems in the future.

In Sec. 123.8(a), FDA is also proposing to require that information

be recorded at the time that it is observed, and that each record be

signed by the operator or observer. It is important that information

relating to observations be recorded immediately to ensure accuracy.

The record should be signed by the individual who made the observation

to ensure responsibility and accountability. Also, if there is a

question about the record, a signature ensures that the source of the

record will be known.

FDA is proposing to require in Sec. 123.8(b) that records receive a

second review by an individual trained in accordance with Sec. 123.9,

for verification purposes, before the product is distributed into

commerce. The purpose of this review is to ensure that the processor or

importer verifies that employees are recording data in HACCP records,

and that deviations from critical limits are being caught before

products that may have been affected can enter commerce. The agency is

proposing to require that this records verification be performed by a

trained individual to ensure that the records are reviewed by a person

who understands the HACCP system, understands the significance of a

processing deviation, and knows how to respond if a deviation occurs.

FDA is proposing in Sec. 123.8(c) to require that HACCP records be

retained for at least 1 year after they are prepared for refrigerated

products and for at least 2 years after they are prepared for frozen or

preserved (i.e., shelf-stable) products. These timeframes are based on

the length of time that these products can be expected to be in

commercial distribution (Ref. 52; Ref. 53, pp. 72-73) plus a reasonable

time thereafter to ensure that the records are there when the FDA

inspector performs the next inspection. They are the same timeframes as

now provided for in the Manual of Operations of the NSSP for the

retention of records for raw molluscan shellfish.

Similarly, FDA is also proposing to require in Sec. 123.8(c) that

the processor retain any records relating to the general adequacy of

the equipment or processes being used by the processor, including the

results of scientific studies and evaluations to determine adequacy,

for 1 year beyond the applicability of these records to refrigerated

products being produced by the processor, and for 2 years beyond the

applicability of the records to frozen or preserved products being

produced by the processor. The processor may need to obtain a written

scientific evaluation of a process, such as a cooking, pasteurization,

or cooling process, to ensure that the process it is using is adequate

to destroy pathogens or to prevent their growth. Such an evaluation may

also be necessary to ensure the adequacy of the cooking, pasteurizing,

or refrigerating equipment that the processor is using. (See the

preamble discussion on cooked, ready-to-eat fishery products.) As with

processing records, these records should be retained for a period of

time that reflects the period that the products to which they relate

can be expected to be in commercial distribution.

FDA recognizes that some processing plants may be closed on a

seasonal basis. Given the nature of the HACCP system, however, FDA may

choose to inspect at least the records of a plant even if the plant is

not in operation. Therefore, FDA is providing in proposed Sec. 123.8(c)

that if a processing facility is closed between seasonal packs, the

records may be transferred to some reasonably accessible location

during the period of closure.

FDA is proposing to require in Sec. 123.8(d) that HACCP plans and

records be available for review and copying by authorized agency

employees at reasonable times. As already discussed, the agency's

access to HACCP records is essential to ensure that the HACCP system is

working, and that the safety of seafood is being ensured by design.

FDA's authority to require maintenance of these records, and to provide

for agency access to them, is fully supported by the holding in

National Confectioners Association v. Califano, 569 F.2d 694-95 (D.C.

Cir. 1978). In this case, the court recognized FDA's authority to

impose recordkeeping requirements on firms that process foods when such

requirements effectuate the goals of the act. See also Toilet Goods

Association v. Gardner, 387 U.S. 158, 163-164 (1967). The importance of

the records in ensuring that fish and fishery products will not be

rendered injurious to health has been fully discussed. FDA access to

these records will expedite the agency's efforts to ensure that the

fish and fishery products in interstate commerce are not adulterated

and to identify any such products that are.

FDA is aware that there is substantial public interest in the

extent to which industry-generated HACCP records could or should be

publicly available. As FDA understands it, the argument in favor of

availability is that where an inspection system to protect the public

health relies heavily on records, those records should be public to the

maximum extent possible. The arguments in favor of protection of

records, on the other hand, are based on concerns about advantages to

competitors from disclosure and on the risk that the records will be

otherwise misused if they become public. FDA invites comment on the

general question of public disclosure of HACCP records and on the

agency's preliminary analysis of their availability, as follows.

FDA has longstanding explicit statutory access to certain industry

records during inspections involving infant formula, drugs, and devices

and has access by regulation to certain processing records during

inspections of low acid canned food processors. The agency has the

right to copy and take possession of these records but does not

routinely do so. FDA typically copies and takes possession of records

only when they may be needed for regulatory purposes. As a preliminary

matter, FDA expects to continue that practice with regard to seafood

HACCP records.

The public availability of those HACCP records that FDA would

possess as a result of copying during an inspection would be governed

by section 301(j) of the act and by the Freedom of Information Act

(FOIA) and regulations issued pursuant to it by the Department of

Health and Human Services (DHHS) and FDA. Section 301(j) of the act

expressly prohibits FDA from disclosing trade secret information

obtained during the course of an inspection. The FOIA regulations also

say that FDA will not divulge either trade secret or commercial

confidential information. As a preliminary matter, HACCP plans and

monitoring records appear to fall within these two categories of

protected records. As a consequence, FDA may well have little

discretion in this area. Moreover, under DHHS' FOIA regulations,

processors may be entitled to challenge in court a pending disclosure

of records on the grounds that the records to be disclosed are

commercial confidential or trade secret.

As an additional matter, there are significant legal and practical

questions as to whether FDA has the authority to require disclosure of

industry records that are not in FDA's possession. As discussed

elsewhere in this document, FDA does not contemplate the submission of

HACCP plans or other records to FDA under these proposed regulations.

The preapproval of HACCP plans by FDA (and thus the submission of HACCP

plans to FDA) is simply not practical. The agency has tentatively

concluded that HACCP plans and monitoring records will be reviewed on

site by agency investigators as part of FDA's normal inspection regime.

FDA is proposing in Sec. 123.8(e) to exempt tags as defined in

Sec. 123.3(t) from the recordkeeping requirements of Sec. 123.8. While

the information on tags must be saved in accordance with the proposed

requirements of this section and Sec. 123.28(d), the agency has

tentatively concluded that it would be burdensome for processors to be

required to retain the tags themselves for extended periods of time.

NSSP now provides that processors are to retain tags for 90 days.

F. Training

Proposed Sec. 123.9 requires that each processor and importer

employ at least one individual who has successfully completed a

training course on the application of HACCP to fish and fishery

products processing. The agency has tentatively concluded that training

is critical to the successful implementation of HACCP systems in the

seafood industry. Based on experience obtained during the FDA/NOAA

HACCP pilot programs in 1991-92, the agency believes that a significant

portion of the seafood industry will be unprepared to meet the

requirements of a mandatory HACCP program without some training. As

discussed earlier, the pilot program revealed a general lack of

understanding of the preventive nature of HACCP, including

misunderstandings about how to establish critical limits, control

measures, corrective actions, and recordkeeping procedures (Ref. 40).

A similar concern that the industry did not understand the

application of HACCP principles formed the basis for the training

requirements in the agency's regulations for low acid canned foods.

Improvements in canning operations can be attributed in significant

measure to the success of the training programs that were established

to implement that requirement (Ref. 54). NAS concluded that the

successful application of HACCP principles to low acid canned foods was

substantially the result of the training requirement in the regulations

for those products (Ref. 36, p. 309). The CGMP regulations for foods in

part 110 also call for training in appropriate food protection

principles (Sec. 110.10(c)).

The often seasonal nature, remote location, and small size of many

seafood processors also support the need for formalized training. All

of these conditions result in difficulty recruiting highly qualified

management and supervisory staff. Thus, FDA has tentatively concluded

that proposed Sec. 123.9 is necessary to ensure that seafood processors

and importers employ at least one person who is familiar with HACCP.

These regulations propose to require at Sec. 123.9 that the person

or persons at each importing and processing establishment who has

received training be responsible for reviewing records of critical

control point monitoring, recognizing critical limit deficiencies, and

assessing the need for corrective actions relative to the product in

question and the HACCP plan itself. While it is the intent of the

agency to provide as much guidance as possible to assist processors and

importers, these activities require specialized training in the

principles of HACCP, various aspects of food science, and the criteria

of existing regulations and guidelines.

The agency anticipates that 2- or 3-day training sessions, modeled

after the Better Process Control Schools currently in place for low

acid canned food and acidified food manufacturers, will be provided by

various public and semiprivate institutions. The uniformity of this

training can be assured by a review of their contents and by periodic

onsite monitoring by the agency. Thus, FDA is proposing to require that

the program of instruction be approved by the agency.

While 2- or 3-day courses may well become the norm, FDA invites

comment on whether the training requirement could be satisfied by

different gradations of training, depending on the complexity or size

of the operation, or on the degree of risk posed by the product being

produced, without compromising the purposes for which training is

proposed to be required. For example, could training for a small

business with few hazards be accomplished in a shorter time and at a

lower cost through the use of a video? FDA also invites comment on

whether training in HACCP received before these proposed regulations

become effective as final regulations should be ``grandfathered'' as

fulfilling the training requirement.

G. Sanitation Control Procedures

1. General

FDA is proposing to require in Sec. 123.10 that processors and

importers that engage in processing perform sanitation inspections at

specified frequencies and maintain sanitation control records that

document the results and frequency of those inspections. If these

regulations are adopted, the sanitation control records will be subject

to the recordkeeping requirements in Sec. 123.8, including review by

FDA investigators.

For seafood, sanitary practices affect most directly the safety of

those products that do not receive any further cooking by the consumer.

These products include raw molluscan shellfish; finfish destined to be

consumed as sushi; cooked, ready-to-eat products; and certain smoked

and salted products. Both finfish and shellfish are regarded as

microbiologically sensitive foods based on the potential presence of

pathogens, notably L. monocytogenes (Ref. 55, pp. 31 and 32).

L. monocytogenes is a pathogenic bacterium that is widespread in

the environment. Thus, the likelihood of finding it on the exterior

surfaces and viscera of fish is high. Since 1983, several large

outbreaks of human listeriosis have been linked to contaminated foods.

Although it is a relatively rare illness, the exceptionally high

mortality rate among susceptible individuals makes this illness one of

the leading fatal foodborne diseases in the United States.

Numerous seafood products have been shown to support growth of L.

monocytogenes (Refs. 56 and 57), and seafoods have been

epidemiologically linked to two outbreaks and one sporadic case of

listeriosis (Ref. 58). Furthermore, several cooked seafood products

have been recalled from the market in North America because of

contamination with L. monocytogenes (Ref. 27). Seven of nine smoked

fish processing facilities recently inspected by FDA in New York State

had L. monocytogenes in the environment or in the products (Ref. 59).

Good sanitation practices are critical to the prevention of

listeriosis and other microbiologically related foodborne illnesses.

FDA's CGMP regulations for food in part 110 set out general principles

of sanitation that should be followed in plants that manufacture,

package, label, or hold human food. They address such matters as

personal hygiene and cleanliness among workers who handle food, the

suitability of the plant design to sanitary operations, and the

cleaning of food-contact surfaces. FDA inspections of seafood

processors apply the principles in part 110.

Nearly half of the consumer complaints relating to seafood that FDA

receives in a typical year are related to plant or food hygiene (Ref.

60). The reasons, while not entirely clear, appear to be related to

factors such as the age of processing facilities, the seasonal nature

of operations that affect training, and the turnover of personnel.

A representative cross section of those FDA establishment

inspection reports (EIR's) for domestic seafood manufacturers that

revealed CGMP deficiencies for fiscal years 1988-90 demonstrates this

point (Ref. 61). The cross section involves 795 EIR's covering 561

facilities. (The number of EIR's exceeds the number of facilities

because followup visits were made to check on the status of corrective

actions.) The following percentages refer to EIR's with deficiencies

where at least some of the deficiencies involved sanitation:

(1) Twenty-three percent documented receiving area facilities that

were not clean/orderly or in good repair.

(2) Twenty-six percent documented facilities lacking effective

insect and rodent control measures in the receiving area.

(3) Sixteen percent documented failure to handle ice in a sanitary

manner and to protect it properly.

(4) Thirty-five percent documented lack of adequate cleaning or

sanitizing of processing equipment.

(5) Twenty-one percent documented processing equipment that was not

constructed so that it could be easily cleaned and sanitized.

(6) Eighteen percent documented processing equipment that was not

made of suitable materials.

(7) Fifteen percent documented hand sanitizers that were not kept

at proper sanitizing levels.

(8) Eighteen percent documented failure to have hand sanitizers

available in the processing area.

(9) Thirty percent documented processing areas that were not

maintained in a clean and sanitary manner.

(10) Forty-two percent documented processing areas with exterior

openings that were not sealed/covered properly to prevent the entrance

of pests or insects.

(11) Sixteen percent documented waste material not being collected/

covered in suitable containers or not being disposed of properly.

(12) Twenty-three percent documented handling of finished product

in a manner that did not preclude contamination.

(13) Twenty-two percent documented employees not taking necessary

precautions to avoid food contamination.

During fiscal years 1991-92, FDA conducted abbreviated inspections

of nearly all domestic manufacturers in its seafood establishment

inventory. These inspections provide data on sanitation practices and

conditions that are generally consistent with the above findings (Ref.

62). Examples of these data are:

(1) Sixteen percent of firms had problems with the general

sanitation condition of their processing areas. (This percentage is

lower than for item 9 above because the universe is all firms, not just

firms with deficiencies.)

(2) Nineteen percent of firms did not clean and sanitize their

processing areas or equipment throughout the day's production. (This

matches most closely with item 4 above but is lower, presumably for the

reason stated in the previously numbered paragraph.)

(3) Twenty-eight percent of firms had employees that were not

following proper sanitation practices in processing activities. (This

figure does not precisely match any of the items listed above because

the EIR's break employee practices down into specific categories, such

as the wearing of hair nets. Some categories involve relatively minor

matters, others are more significant. Findings with respect to these

employee practices were not listed above for the sake of brevity.)

(4) Twenty percent had employees that were not following proper

sanitation practices for packaging and finished product storage. (The

parenthetical observations in the previously numbered paragraph apply

here as well.)

(5) Thirty-six percent of firms either lacked hand sanitizers in

their processing areas or had sanitizers that were not kept at proper

sanitizing levels. (This finding is equivalent to a combination of

items 7 and 8 above. Surprisingly, this finding is roughly the same as

7 and 8 added together, even though it includes all processors rather

than processors with deficiencies.)

Sanitation problems found by NMFS during the operation of its fee-

for-service inspection program for seafood manufacturers, as described

earlier, are generally consistent with FDA's findings. Entrants into

the NMFS program undergo initial sanitation surveys by NMFS and are

checked for sanitation practices thereafter. NMFS' data show

significant sanitation deficiencies during the initial surveys (Ref.

35, p. 40). Some of the most common for 1989 include:

(1) Sixty-four percent of plants had discrepancies relating to

proper cleaning and sanitizing of product contact surfaces or

equipment, containers, or utensils after use.

(2) Fifty-one percent of plants had discrepancies relating to

design, materials, or construction that prevented their being

maintained in a sanitary manner.

(3) Forty-five percent of plants had discrepancies relating to

design of equipment, containers, and utensils so that they did not

provide protection from contaminants and could not be readily cleaned

and effectively sanitized.

(4) Forty-three percent of plants had discrepancies relating to

improper storage of equipment, litter, waste, uncut weeds, and grass.

(5) Forty percent had discrepancies relating to storage facilities

that were not clean, sanitary, or in good repair.

For established participants in the NMFS program (as opposed to

entrants), the percentages with discrepancies in the above areas for

1989 were: 49 percent; 47 percent; 25 percent; 49 percent; and 33

percent (Ref. 35, p. 42).

FDA has tentatively concluded on the basis of all of these findings

that HACCP-type controls for sanitation as proposed below are needed.

The sanitation measures required under proposed Sec. 123.10 are

fundamental to good sanitation practices and can have a bearing on

human safety. The agency recognizes, however, that depending on the

conditions in a facility, additional measures may be necessary (see,

e.g., part 110). FDA will expect processors to include those measures

in their sanitation practices but tentatively concludes that it is not

necessary to include them in the fundamental core of required steps.

FDA acknowledges the conclusion of the MSSP project that, for

seafood at least, it is possible to include sanitation within an HACCP

system without unduly overburdening that system with large numbers of

critical control points. The FDA/NOAA HACCP-based seafood pilot program

included critical control points for sanitation. For these regulations,

however, FDA has tentatively decided to propose specific HACCP-type

requirements for sanitation, rather than require that processors

identify critical control points for sanitation in their HACCP plans.

The proposed requirements in Sec. 123.10 potentially relate to an

entire facility, not just to a limited number of critical control

points. FDA tentatively concludes that this step is necessary to fully

implement section 402(a)(4) of the act and yet at the same time not

overload the HACCP system. FDA invites comments on this approach.

In particular, FDA invites comment on whether sanitation

requirements should be enumerated as in proposed Sec. 123.10. The

logical alternative would be to leave sanitation as one of the

procedures that is to be identified and addressed in HACCP plans for

the control of microbiological and physical hazards (see proposed

Sec. 123.6(b)(1)(ii), (b)(1)(ix), and (b)(4)), but not to have specific

provisions in the regulations as to how sanitation is to be achieved.

Good sanitation blocks avenues for the introduction of pathogens,

harmful chemicals, and physical objects and is an essential preventive

control for safety. Even if a product is to be cooked by the consumer,

the load of microbiological pathogens on that product when received by

the consumer is still relevant to safety. FDA's prescriptive approach

to sanitation in proposed Sec. 123.10 is intended to assist processors

to provide the greatest protection for consumers. Nonetheless, FDA

invites comment on whether an alternative approach as described above

would ensure this protection at less cost.

FDA is proposing in Sec. 123.10(a) to require that processors

conduct sanitation inspections to ensure that the sanitation conditions

in Sec. 123.10(a)(1) through (a)(17) are met. FDA recognizes that the

nature of the operations conducted by a processor affects the hazards

that may be presented by the product. Processing other than storing

usually involves manipulation of exposed, i.e., unpackaged, fish and

fishery products. Both the manipulation and the exposure subject the

product to all the hazards that can occur from unsanitary practices.

Storage, on the other hand, can subject the product to some, but

nowhere near all, of the hazards associated with insanitation.

Consequently, FDA is proposing to require that processors of fish and

fishery products inspect for those conditions in Sec. 123.10(a)(1)

through (a)(17) that are appropriate to their circumstances. FDA

expects that, at a minimum, in, for example, storage facilities, such

inspections will include ensuring against the presence of vermin,

because this is a frequent problem in warehouses that can affect

products even when they are being stored in a packaged state.

In Sec. 123.10(a)(1), the agency is proposing to require that

processors ensure that water that contacts the product or food-contact

surfaces, or that is used in the manufacture of ice, is derived from a

safe and sanitary source or is treated to render it of safe and

sanitary quality. Water is used in virtually all fish and fishery

product processing facilities for washing raw materials, product

contact surfaces, and employees' hands. It is used to transport fish

through the plant in water flumes. In addition, water is often an

ingredient, as in soups and glazes. Contaminated water can serve as a

vehicle for contamination of the product, both directly and indirectly

(Refs. 63, 64; 65, p. 49; 66, 67, and 68, pp. 1 and 2). It can also

serve as a vehicle for contamination as the ice in which the product is

stored.

The safety and sanitary quality of water from United States and

some foreign public water systems is generally ensured through public

water treatment, chlorination, or monitoring and control by local

health authorities. Where this assurance exists, FDA does not

anticipate that processors will need to implement any additional

controls.

Private sources of water, particularly surface waters or water from

shallow wells, may be subject to microbiological, chemical, or

radiological contamination attributable to the source itself or to

surface contamination at the well head or intake. Private sources are

also frequently untreated or minimally treated (Refs. 69, p. 15; and

70). Where the processor uses a private source of water, it will need

to take steps to ensure that the water is of a safe and sanitary

quality. These steps may include retaining a copy of the initial local

health authority well design approval and copies of the local health

authority fecal coliform test results; obtaining and maintaining copies

of private coliform test results; performing and recording periodic

inspections of the sanitary condition of the well head or source

intake; and performing and monitoring appropriate water treatment

procedures, including filtration, sedimentation, and chlorination.

The type and frequency of controls exercised by the processor

should be based upon the type of source water and its historic safety

and sanitary quality. Consequently, the agency is proposing to require,

in Sec. 123.10(c)(3), that such controls be performed and documented at

such frequency as necessary to ensure control. In Sec. 123.10(a)(2), as

a means of ensuring that potable water does not become contaminated,

the agency is proposing to require that the processor ensure that there

are no cross connections between the potable water system and any

nonpotable systems. Nonpotable systems include waste water and sewage.

Cross connections, which include situations that allow for back

siphonage into a potable system from a nonpotable system under negative

pressure conditions, can result in the chemical or microbiological

contamination of the potable water system (Refs. 64; 65, pp. 50 and 51;

68, 71, and 72). For example, if a hose from a potable water system is

left in a thawing tank with water and frozen fish, and if negative

pressure occurs that draws water from the tank back through the hose to

the potable water system, both the potable water line and the water

source itself, i.e., the municipal or private water system, can become

contaminated.

Cross connections can best be controlled by performing periodic

inspections of the potable and nonpotable systems. These inspections

should be performed at least every time that there is a change in the

plumbing of the systems and with sufficient additional frequency to

ensure that unintentional cross connections do not develop.

Consequently, in Sec. 123.10(c)(3), the agency is proposing to require

that such inspections be performed and documented at such frequency as

necessary to ensure control.

FDA is proposing in Sec. 123.10(a)(3) to require that the processor

ensure that all food-contact surfaces are designed, constructed, and

maintained in a manner that minimizes the potential for chemical and

microbiological contamination of the product. Utensils and equipment

can be vehicles for microbial contamination of both the raw and

finished products. Utensils, equipment, and other food-contact surfaces

that are made of corrosive material or wood, or that contain breaks,

pits, cuts, or grooves, may harbor pathogenic microorganisms that can

migrate to the product and contaminate it. These kinds of surfaces are

difficult to clean, with the pores and crevices shielding the

microorganisms from the action of cleaning and sanitizing agents (Refs.

65, pp. 20, 36-48; 72, pp. 166 and 167; and 73).

Additionally, where food-contact surfaces are constructed of toxic

materials (e.g., lead shucking blocks), the product may be directly

contaminated with the toxic material (Ref. 74). Therefore, FDA

tentatively concludes that it is necessary to require that processors

take affirmative steps to minimize the possibility that any risks will

be created by the utensils and equipment they use.

Proper construction of the equipment should be ensured at the time

it is received, and whenever it is modified or repaired. The frequency

of subsequent inspections necessary to ensure that the sanitary

condition of the equipment has not declined with time will depend on

the frequency of its use, the materials and construction methods, and

the nature of its use. In Sec. 123.10(c)(3) the agency is proposing to

require that such controls be performed and documented with such

frequency as is necessary to ensure control.

In Sec. 123.10(a)(4), the agency is proposing to require that the

processor ensure that food-contact surfaces are regularly cleaned and

sanitized with cleaning and sanitizing preparations that are suitable

for this purpose. Surfaces that are not adequately cleaned and

sanitized can be a source of filth to subsequent products produced on

the equipment, an attractant for vermin, and a reservoir for pathogenic

microorganisms. Infrequent cleaning of equipment can result in the

formation of biofilms, microscopic films in which microorganisms can be

entrapped, shielded from the action of sanitizers, and physically bound

to the food-contact surface of the equipment.

An effective cleaning compound is one that will lower the surface

tension of water so that spills can be lifted and flushed away.

Ordinary soap is generally ineffective for equipment washing because of

its limited ability to solubilize fats, oils, and proteins. Mildly

alkaline detergents are generally suitable for cleaning seafood

processing plants, but high alkaline detergents are often necessary for

he

This text is long and has been trimmed here. Open the source document for the complete record.