[Federal Register Volume 59, Number 19 (Friday, January 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1592]


[Federal Register: January 28, 1994]


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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Parts 123 and 1240



Proposal To Establish Procedures for the Safe Processing and Importing 
of Fish and Fishery Products; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 123 and 1240

[Docket Nos. 90N-0199 and 93N-0195]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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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 
heavy buildups of fats and proteins. Mineral deposits will frequently 
require the use of acid cleaners.
    An effective sanitizing agent is one that has a good bacteriocidal 
effect on the types of pathogens normally present in the plant 
environment and is safe, stable, and convenient for use. Examples 
include hypochlorites, iodophors, and quaternary ammonium compounds 
(Refs. 73, 74, 75, 76, and 77).
    To eliminate the product residue that accumulates on product 
contact surfaces during production, FDA is proposing in 
Sec. 123.10(a)(4)(i) to require that utensils and surfaces of equipment 
that contact food during processing be thoroughly washed at the end of 
the day's operations. FDA is also proposing in Sec. 123.10(a)(4)(iii) 
that sanitizing be performed on the same utensils and equipment 
immediately before the beginning of production, so that any 
recontamination that occurs between cleaning and production can be 
eliminated.
    FDA is proposing to require in Sec. 123.10(a)(4)(ii) that, in those 
operations in which microbiological contamination can adversely affect 
the safety of the product (e.g., the processing of cooked, ready-to-eat 
products), the equipment also be washed and sanitized at least every 4 
hours during processing. Washing and sanitizing with this frequency is 
necessary to inactivate mesophilic pathogens, such as Salmonella spp., 
before they leave the lag phase of growth and enter the rapid log phase 
(Ref. 23). Temperatures in fish and fishery product processing plants 
are generally not low enough to control the growth of such 
microorganisms and are certainly not low enough to control the growth 
of such psychrotropic pathogens as L. monocytogenes (Refs. 23, 78, 79, 
and 80). Therefore, FDA tentatively finds that washing and sanitizing 
equipment every 4 hours is necessary.
    FDA is proposing to require both cleaning and sanitizing because 
neither step is fully effective without the other. When sanitizing 
occurs without benefit of cleaning, pathogenic microorganisms can be 
protected from the action of the sanitizer by food residue. Conversely, 
while cleaning can effectively remove product residue and a portion of 
the microorganisms, sanitizing is generally needed to remove the 
remaining microorganisms (Refs. 81 and 82).
    FDA is proposing to require in Sec. 123.10(c)(2) that the processor 
inspect the condition of the utensils and surfaces of equipment that 
contact food immediately after each cleaning and sanitizing. The 
purpose of the inspection is to ensure the adequacy of the cleaning and 
sanitizing operations, and to ensure that the equipment is in a 
condition that is suitable for further operations.
    The agency is also proposing in Sec. 123.10(c)(2) that the 
processor document the time of each cleaning and sanitizing, the 
concentration of the sanitizer, and the condition of the equipment. 
Documentation of the time of each cleaning and sanitizing will 
facilitate an assessment of compliance with the frequency requirement 
of Sec. 123.10(a)(4). Documentation of the concentration of the 
sanitizer will facilitate an assessment of the adequacy of the 
sanitizing operation. Sanitizers must be of sufficient strength to be 
effective, while excessive sanitizer concentrations can contaminate the 
product with indirect food additives (21 CFR part 178) (Ref. 82). 
Documentation of the condition of the equipment is necessary to ensure 
that it is examined after cleaning and sanitizing to make sure that 
these processes were done properly.
    The agency is proposing in Sec. 123.10(a)(5) to require that the 
processor ensure that gloves and outer garments that contact the food 
or food-contact surfaces are made of an impermeable material and are 
maintained in a clean and sanitary condition. Gloves or aprons that are 
made of cloth or other porous materials are difficult to clean and may 
serve as a reservoir for pathogenic microorganisms that can migrate to 
the food during processing, in much the same manner as previously 
described for processing equipment (Refs. 65 and 83). Gloves and aprons 
that are not maintained in a clean and sanitary condition can also 
house pathogens that can migrate to the food. Therefore, FDA 
tentatively finds that it is appropriate to require the measures set 
out in Sec. 123.10(a)(5).
    At Sec. 123.10(c), the agency is proposing to require that, like 
most of the other sanitation measures that FDA is proposing, the 
sanitary condition and impermeability of gloves and outer garments that 
may contact the food or food-contact surfaces be checked at least daily 
while processing operations are occurring. Such checking will ensure 
that employees arriving for work are equipped with gloves and outer 
garments that will not serve as a source of contamination to the 
product. It will also ensure that employees are never using personally 
owned gloves and garments that are made of materials that are 
unsuitable for the processing environment. Proposed Sec. 123.10(c) also 
requires that such checking be documented on a daily basis to provide a 
record that such checking has occurred.
    Under proposed Sec. 123.10(a)(6), the processor must ensure that 
employees' hands, gloves, outer garments, utensils, and food-contact 
surfaces that come into contact with insanitary objects are thoroughly 
cleaned and sanitized before contacting fish or fishery products. Under 
proposed Sec. 123.10(a)(7), the processor must also ensure that 
employees' hands, gloves, outer garments, utensils, and food-contact 
surfaces that contact raw products are thoroughly cleaned and sanitized 
before they contact cooked product.
    Employees and food-contact surfaces can serve as vectors in the 
transmission of filth and pathogenic microorganisms to the food. Filth 
and pathogenic microorganisms can be brought into the processing 
environment on the employees' hands from outside areas, restrooms, 
contaminated raw materials, waste or waste receptacles, floors, and 
other insanitary objects (Refs. 63, 64, 73, 74, 84, and 85).
    Bacteria naturally present on fresh fish skin and gills and in the 
gastrointestinal tract reflect the microbial content of the water from 
which the fish were harvested. Typical microorganisms found on and in 
fresh fish include C. botulinum, enteric bacteria, Vibrio 
parahaemolyticus, salmonella, shigella, hepatitis A, and other 
microorganisms that pollute harvest waters (Ref. 7). These 
microorganisms contaminate the environment in processing plants and 
cannot, using reasonable methods, be completely eliminated.
    Proper precautions, such as proper hand and equipment cleaning and 
sanitizing, must be taken to minimize opportunities for contamination 
of the finished product (Refs. 63, 64, 73, 74, and 84). Therefore, FDA 
is proposing in Sec. 123.10 (a)(6) and (a)(7) that such precautions be 
taken with respect to hands, gloves, garments, utensils, and food-
contact surfaces.
    The agency recognizes that not all processing activities will 
require hand washing and sanitizing. Activities that would not require 
such steps include the handling of raw fish and fishery products prior 
to the initial washing step (i.e., directly from the fisherman) and the 
handling of finished products in shipping cases. These activities are 
exceptions, however, to the general rule that employees must thoroughly 
wash and sanitize their hands after each contact with an insanitary 
surface. Additionally, when insanitary objects come into contact with 
product contact surfaces, they must be thoroughly cleaned and 
sanitized.
    In the processing of cooked products, the raw material may also 
serve as a reservoir of pathogenic microorganisms. For this reason, 
employees or equipment that handle or touch the raw material must be 
cleaned and sanitized before being used with cooked product or ice, or 
they could convey the microorganisms to these foods (Refs. 63, 64, 73, 
74, 84, 87, and 88).
    In Sec. 123.10(c)(1), the agency is proposing to require that the 
sanitary practices of the employees, especially as they relate to hand 
washing, sanitizing practices, and the potential for cross 
contamination, be checked and recorded at least every 4 hours during 
processing. This monitoring will ensure that employees arriving for 
work and returning from the midshift break have properly washed and 
sanitized their hands. The concentration of hand sanitizing solutions 
tends to be reduced over the course of a production day because of the 
reaction of the sanitizer with organic matter and dissipation as a gas 
(Ref. 82). It will also cause a regular assessment of the adequacy of 
the normal operating procedures. Finally, recording will provide 
assurance that appropriate procedures are being followed.
    In Sec. 123.10(a)(8)(i), FDA is proposing to require that hand 
washing facilities be located in all processing areas in which washing 
and sanitizing is required by CGMP's so that these facilities are 
readily accessible to employees who work in processing areas. The 
agency has tentatively concluded that proper sanitization is such an 
important part of preventing the spread of disease as to warrant a 
requirement that hand washing equipment be conveniently located to 
facilitate their use. Where these facilities are not conveniently 
located, they may not be frequented by the employees.
    FDA is proposing to require in Sec. 123.10(a)(8)(ii) that these 
facilities be equipped with hand cleaning and effective sanitizing 
preparations and single-service towels or suitable hand drying devices. 
Ordinary soap is acceptable for hand washing. Hand sanitizers need to 
be fast acting because of the short contact time involved. In contrast 
to the sanitizing of equipment, which can involve leaving a sanitizing 
spray on the equipment for extended periods of time, hand sanitizing 
usually involves a quick dip in and out of the sanitizer. Of the 
sanitizers described previously (see discussion of proposed 
Sec. 123.10(a)(4)), quaternary ammonium is not fast acting and is not 
suitable as a hand sanitizer. The others are appropriate as hand 
sanitizers.
    The agency is proposing to require single-service towels or 
suitable hand drying devices to ensure that microbiological 
contamination does not occur though the repeated use of the same towel 
by several individuals. A hot-air blower is an example of a suitable 
hand drying device because contamination from individual to individual 
is eliminated.
    In Sec. 123.10(c)(3), the agency is proposing to require that 
inspection and documentation of the location of hand washing facilities 
be performed at sufficient frequency to ensure that there is compliance 
with Sec. 123.10(a)(8)(i). Generally, this procedure will be necessary 
only after construction or any significant building or process 
modification.
    FDA is proposing to require in Sec. 123.10(c) that the processor 
inspect, and document that it has inspected, the hand washing and hand 
sanitizing facilities to ensure that they are properly equipped no less 
than once per day. This procedure will ensure that cleaning and 
sanitizing preparations, as well as towels or hand drying devices, are 
present whenever needed by employees.
    FDA is proposing to require at Sec. 123.10 (a)(9) and (a)(10) that 
the processor protect the food, food-contact surfaces, and food 
packaging materials against adulteration by chemical and physical 
contaminants. Such protection is necessary to ensure that the food 
produced by the processor is safe. The use of toxic compounds (e.g., 
pesticides, cleaning and sanitizing agents, and lubricants) is 
frequently necessary in the processing environment. For example, 
lubricants and fuel are necessary to operate equipment. Improper use of 
these compounds is a frequent cause of product adulteration throughout 
the food industry (Ref. 74). Thus, it is necessary to ensure that food, 
food-contact surfaces, and food packaging materials are not 
contaminated by these toxic compounds. Food and food packaging material 
should be protected or removed from areas where pesticides are used, 
and caustic cleaning compounds should be thoroughly removed from food-
contact surfaces before processing begins. Finally, as an additional 
protection, FDA is proposing to require in Sec. 123.10(a)(10) that 
toxic compounds be labeled, held, and used in a manner that minimizes 
the risk of contamination of the product.
    FDA is proposing to require in Sec. 123.10(c) that the processing 
plant be inspected daily to ensure that the food is protected from 
toxic compounds, and that this inspection be documented. This check 
should normally be performed before the start of operations, at a time 
when the equipment can be effectively inspected, and in time to prevent 
adulteration of the product. Because processing conditions vary on a 
day-to-day basis, FDA has tentatively concluded that daily inspection 
is necessary.
    FDA is proposing to require at Sec. 123.10(a)(11) that the 
processor ensure that products are not exposed to contaminants that may 
drip, drain, or be drawn into the food. An example of such a 
contaminant is condensate, which may form on the ceilings and equipment 
in a processing plant. If the condensate forms on an insanitary surface 
and then falls on the product, it may carry with it filth and 
microbiological contaminants from that surface to the food (Ref. 65, 
pp. 24 and 25).
    In Sec. 123.10(c), the agency is proposing to require that the 
processing plant be inspected daily to ensure that the potential for 
such contamination is minimized, and that this inspection be 
documented. This check should normally be performed during the actual 
operations, at a time when condensate or other such contaminating 
conditions are likely to be present. As explained above, the agency has 
tentatively concluded that daily variations in processing and climatic 
conditions necessitate daily inspection.
    In Sec. 123.10(a)(12), the agency is proposing to require that the 
processor ensure that compressed gases that contact food or food-
contact surfaces of equipment are filtered or treated in such a way 
that the food is not contaminated with unapproved indirect food 
additives or other chemical, physical, or microbiological contaminants. 
Compressed gases can be contaminated with oil from the compressor, 
filth and microbiological contaminants from the air intake, and rust or 
other physical contaminants from the compression, storage, and 
distribution equipment. Filtration at the air intake and after 
compression, storage, and distribution is an effective means of 
reducing the risk of such contaminants entering the food (Ref. 89).
    FDA is proposing to require in Sec. 123.10(c)(3) that the 
filtration and other equipment used to protect the food from such 
contaminants be inspected, and the inspection documented, with such 
frequency as is necessary to ensure control. Normally, this frequency 
will be directed by the manufacturer of the filtration equipment. FDA 
is not proposing to require daily inspection because the filter and 
related equipment do not normally need cleaning or replacement on a 
daily basis.
    FDA is proposing to require in Sec. 123.10(a)(13) that the 
processor take action to ensure that unprotected cooked, ready-to-eat 
fishery products, smoked fishery products, raw molluscan shellfish, and 
raw fish and fishery products are physically separated from each other 
during refrigerated storage. Cooked, ready-to-eat products are products 
that will not normally receive a cooking by the consumer adequate 
enough to kill pathogens. Therefore, any microbiological 
recontamination of the product after cooking can subject the consumer 
to health risks. Raw molluscan shellfish may contain pathogens that can 
cause severe illness to certain at-risk individuals, e.g., those who 
are immunocompromised. These individuals might know to avoid eating raw 
molluscan shellfish but would not expect the same health risk from 
cooked, ready-to-eat products. Similarly, raw fish and fishery products 
may contain filth and pathogenic microorganisms not normally associated 
with raw molluscan shellfish or cooked, ready-to-eat products (Refs. 63 
and 84).
    In Sec. 123.10(c), the agency is proposing to require that 
refrigerated storage areas be inspected at least daily to ensure that 
the three types of products are physically separated from each other. 
This check should normally be performed during actual operations, at a 
time when commingling of these products is likely to take place. The 
agency has tentatively concluded that daily inspection is necessary 
because products are normally moved in and out of refrigerated storage 
areas on a regular basis, creating an ongoing threat that problems will 
occur.
    FDA is proposing to require in Sec. 123.10(a)(14) that refrigerated 
storage units operate at 40  deg.F (4.4  deg.C) or below when storing 
raw materials, in-process or finished cooked, ready-to-eat fishery 
products, smoked fishery products, and fish and fishery products made 
in whole or in part of scombroid toxin forming species. The purpose of 
this requirement is to ensure that processors control microbiological 
hazards associated with refrigerated storage for these products (Refs. 
85 and 86). Cooked, ready-to-eat products as defined in proposed 
Sec. 123.3(b) and smoked fishery products (see Appendix 1) are not 
shelf-stable and must be kept refrigerated to retard the growth of 
microorganisms. As stated above, these products will not normally be 
cooked by the consumer at a sufficient temperature to destroy any 
pathogens that may be present. Scombroid toxin forming species are 
addressed in considerable detail later in this document. These species 
can form a toxin harmful to humans if subjected to time/temperature 
abuse after capture.
    Proper refrigeration is essential for fish and fishery products 
that include these species. Maintaining product temperatures during 
storage in a range that will minimize the growth of mesophilic and 
psychrotropic pathogens is necessary to ensure product safety 
throughout the shelf life of these products (Ref. 85). It is uniformly 
more convenient to control refrigeration unit temperatures than to 
control and monitor the internal temperatures of the various products 
under refrigerated storage, particularly when these products are in 
sealed containers. For these reasons, FDA is proposing that 
refrigeration units be operated at or below 40  deg.F (4.4  deg.C). FDA 
tentatively finds that this temperature is appropriate because it is 
adequate to minimize the growth of pathogens (Refs. 85 and 86.) The 
agency also strongly recommends this temperature or lower for all fish 
and fishery products that need refrigeration, regardless of whether 
safety is an issue. The agency is also especially interested in 
obtaining comment on the appropriateness of this temperature.
    In Sec. 123.10(c)(4) the agency is proposing to require that the 
processor use instruments that monitor the temperature of refrigeration 
units on a continuous basis. The measurements from those instruments 
must be checked and documented with such frequency as is necessary to 
ensure control.
    Continuous monitoring ensures that temperature fluctuations above 
40  deg.F (4.4  deg.C), if any, as a result of circumstances such as 
heavy cooler loading, frequent cooler entry, or power failures, are 
quickly detected. The guideline for cooked, ready-to-eat products, in 
Appendix A, section 6, describes alternative ways to continuously 
monitor the temperature. A temperature-recording device can show both 
the high temperature and the length of time that refrigeration unit was 
operating at that temperature. Maximum-indicating thermometers and high 
temperature alarms also show that the critical limit has been exceeded 
but cannot show the duration of the deviation. Consequently, when a 
maximum-indicating thermometer or high temperature alarm reveals a 
deviation, the processor will need to assume loss of control since the 
last time that the measurements displayed by the instruments were 
checked, unless reasonable evidence exists to the contrary. The more 
frequent such checks are made, the lower the risk to which the 
processor is exposed. During periods when the refrigeration unit is not 
frequently entered and the load is constant, such as overnight, it is 
reasonable to reduce the frequency. However, during periods of heavy 
use and frequent entry, the frequency should be increased.
    FDA is proposing to require in Sec. 123.10(a)(15) that the 
processor ensure that persons with sores or illnesses that present an 
increased risk for product contamination are excluded from those areas 
of processing where such contamination is likely. Employees can serve 
as a reservoir of foodborne diseases, such as salmonellosis, 
shigellosis, and hepatitis, that can be passed on to the consumer 
through the fecal-oral route. Additionally, open sores, boils, or 
infected wounds present the potential for contamination of the food 
with such pathogenic microorganisms as Staphylococcus aureus. Employees 
with suspicious illnesses or sores can be effectively screened upon 
arrival at the processing facility with minimal personal intrusion 
(Refs. 22, 74, and 84).
    In Sec. 123.10(c), the agency is proposing to require that such 
screening, and documentation of the screening, take place daily. This 
frequency will ensure that changing health conditions of the employees 
are not missed.
    In Sec. 123.10(a)(16), the agency is proposing to require that the 
processor ensure that toilet facilities are available and maintained in 
a sanitary condition and in good repair, and that these facilities 
provide for proper disposal of the sewage. Toilet facilities eliminate 
from the processing environment pathogenic microorganisms shed in fecal 
material. Where fecal material is not properly conveyed from the 
processing plant to an acceptable treatment facility, restroom floors 
and grounds around the processing facility can become contaminated with 
pathogens. Foot traffic over the affected areas can introduce pathogens 
to the processing room and cause product contamination. Insanitary 
toilet facilities can also increase the potential for contamination of 
employees' hands and, ultimately, the product (Refs. 64 and 74).
    FDA is proposing to require at Sec. 123.10(c) that the toilet 
facilities be inspected, and the inspection be documented, to ensure 
that they function properly and are in a sanitary condition at least 
every day. Ordinarily this inspection should be performed before each 
day's operation to ensure that the facility is ready at the beginning 
of the day.
    In Sec. 123.10(a)(17), the agency is proposing to require that the 
processor ensure that no pests are present in the processing area. 
Pests, such as rodents, birds, and insects carry a variety of human 
disease agents, which they can introduce to the processing environment 
(Refs. 63, 64, 73, and 84). Additionally, their feces constitutes filth 
which can contaminate the food. A daily inspection of the processing 
facility, as proposed in Sec. 123.10(c), serves to assess the 
effectiveness of the processor's pest control activities and redirect 
them where necessary.
    In Sec. 123.10(a)(18), the agency is proposing to require that the 
processor ensure that the plant is designed to minimize risk of 
contamination of the food. Proper construction is essential if the 
other sanitary measures that FDA is proposing to require are to be 
successful. It includes the isolation of incompatible operations, such 
as the handling of raw materials and the processing of cooked products 
(Refs. 71, 74, 87, and 88). A periodic inspection of the facility for 
structural defects, product flow, and general building condition is 
necessary to ensure that these attributes do not pose an increased 
potential for product contamination. In Sec. 123.10(c)(3), the agency 
is proposing to require that such controls be performed and documented 
with sufficient frequency to ensure control.
    FDA is proposing to require at Sec. 123.10(b) that processors 
maintain sanitation control records that document the occurrence and 
findings of the inspections required by Sec. 123.10(a) as well as the 
frequency required by Sec. 123.10(c). FDA is also proposing to require 
that the problems found during these inspections be corrected, and the 
corrections recorded in accordance with proposed Sec. 123.10(d). Such 
corrections are essential to the proper working of the HACCP system. 
The records that are produced are subject to the recordkeeping 
requirements of proposed Sec. 123.8, including being subject to 
inspection by FDA investigators. FDA has tentatively concluded that 
HACCP-type preventive controls, including recordkeeping, will ensure 
that the hazards caused by insanitation are controlled by design. 
Recordkeeping is the key to an HACCP-type system. The agency's access 
to these records is essential to ensuring that the system is working.
    In addition to these proposed requirements, FDA is encouraging 
processors in Sec. 123.10(e) to have a written standard operating 
procedure for sanitation. The details of many sanitation procedures can 
differ from plant to plant depending upon the type of operation and 
other conditions. For example, how a piece of equipment should be 
cleaned can differ from plant to plant. In one plant, it may be 
necessary to disassemble all or part of the equipment in order to clean 
it. In other plants, breaking down the equipment may not be necessary. 
Likewise, different cleaning compounds may be needed from one plant to 
another in order to solve specialized problems such as buildups of 
mineral deposits. FDA is therefore encouraging each processor to study 
its own plant and develop a procedure that is tailored to that 
processor's needs and circumstances.
2. Evisceration of Raw Fish
    In 1988, following botulism outbreaks traced to consumption of 
kapchunka, FDA published compliance policy guide (CPG) 7108.17 for 
salt-cured, air-dried, uneviscerated fish (53 FR 44949 November 7, 
1988). In this CPG, FDA stated that the processing and sale of smoked 
and salted uneviscerated fish products pose a potential health hazard, 
and that it would consider such products to be adulterated under 
section 402(a)(4) of the act in that they have been prepared, packed, 
or held under insanitary conditions whereby they may have been rendered 
injurious to health (Ref. 175). FDA issued this CPG in an effort to 
prevent further outbreaks, as well as other potential health hazards, 
related to the consumption of ungutted fish products. The agency 
recognized only two exceptions: (1) Small species, such as anchovies 
and herring pieces (sprats), provided that they are processed by a 
method that will ensure a water-phase salt content of at least 10 
percent, a water activity below 0.85, or a pH of 4.6 or less; and (2) 
fish that are fully cooked before further processing.
    As previously noted, C. botulinum, as well as other microorganisms, 
are naturally present in the intestinal tract of both fresh-water fish 
and marine fish. Therefore, it is essential not only to remove the 
viscera but to do so in a manner that does not contaminate the fish 
flesh with viscera contents. It is the viscera that can contain the 
majority of the hazardous microorganisms (e.g., C. botulinum and L. 
monocytogenes) that pose the potential health hazard (Refs. 165 through 
167). After the viscera is removed, it must be discarded immediately to 
a segregated area, using a method that minimizes the potential for 
contamination or cross-contamination of utensils, equipment, raw 
materials, and other processed products.
    Uneviscerated fish that have been smoked, smoke-flavored, or 
salted, and that are intended to be filleted after processing, pose the 
same potential health hazard as those products sold as uneviscerated 
whole fish. The potential health hazard is created when the viscera is 
removed after processing. As the fish are being filleted, the viscera 
may be cut, and its contents may spill out, contaminating the processed 
fish. As a result, the opportunity arises for C. botulinum spore 
outgrowth and toxin production as well as for growth of other food 
spoilage microorganisms in these types of products.
    Therefore, the agency is proposing to require in Sec. 123.10(f) 
that, subject to the same limitations that were set forth in the CPG: 
(1) All fish for smoking or salting be eviscerated prior to processing, 
and (2) the process of evisceration must be performed in an area that 
is segregated and separate from other processing operations.

H. Imported Seafood

    As stated earlier, imports make up over half of the seafood 
consumed in this country, in sharp contrast to meat and poultry, which 
are primarily domestically produced. Many of the hazards that can 
affect imported seafood are likely to occur before it enters the United 
States. These hazards include those that can be acquired from the 
environment before harvest and those that are process-induced. 
Detection of these hazards is the focus of the current regulatory 
system, and thus FDA tries to ensure safety by testing imported 
product.
    However, product testing places a substantial burden on the agency. 
The system currently is overburdened because of limits on the number of 
government personnel available to collect and analyze samples of 
imported product. In addition, FDA is concerned because this system 
does not promote industry responsibility and accountability the way an 
HACCP-based problem prevention system would. Given when most problems 
with imported seafood occur, these problems can be more efficiently 
controlled if the seafood is subject to HACCP controls before it is 
offered for import into this country than if the product is simply 
tested at the time that it is offered for sale. Therefore, FDA has 
tentatively concluded that these HACCP regulations should cover 
imported products in the same manner, to the extent possible, that they 
cover domestic products.
    Accordingly, FDA is proposing to make importers subject to the 
general provisions of subpart A. Thus, FDA is proposing in 
Sec. 123.11(a) to require that products that are offered for import be 
produced under the same HACCP and sanitation controls that it is 
proposing to apply to domestically produced seafood. FDA is proposing 
to require that importers adopt an HACCP plan that includes the 
criteria for how they will decide to purchase and then handle seafood 
while it is under their control. They must also establish ways to 
determine that these requirements are being met.
    More specifically, the plan must include hazard analysis, critical 
control points, and critical limits for each type of product imported 
as well as a copy of each supplier's HACCP plan for those products, as 
required in Sec. 123.11(b). Under proposed Sec. 123.11(b), these plans 
must be available on file at the importer's U.S. place of business. As 
stated above, the agency is developing a hazard analysis book to assist 
importers, as well as processors, in designing their individual plans.
    Because of the proposed requirement of Sec. 123.11(b) that 
importers must have on file an HACCP plan from each of their foreign 
suppliers, foreign processors who wish to offer their products for 
import into the United States after the implementation of this 
regulation will have to operate under valid HACCP plans and sanitation 
control procedures and furnish copies of those plans to the U.S. 
importers. The foreign processors should maintain appropriate 
monitoring records, as dictated by the principles of HACCP already 
discussed. These records should be kept at the foreign processors' 
places of business.
    Importers will be required under proposed Sec. 123.11(c) to take 
affirmative steps to monitor that their suppliers are in fact operating 
under their HACCP plans. Thus, under this proposal, the importer will 
need to take such steps as: (1) Obtaining records from the foreign 
processors' facilities; (2) obtaining certification from foreign 
governments that the suppliers are operating under valid HACCP plans or 
obtain certification lot by lot; (3) visiting the facilities to inspect 
them on a regular basis; or (4) taking some similar type of action, 
e.g., end product testing.
    For example, importers of swordfish may specify to their suppliers 
that the mercury level in the swordfish that they purchase cannot 
exceed FDA's action level of 1 part per million methyl mercury. The 
importers may decide to require certificates of analysis for methyl 
mercury on a regular basis from their suppliers as a means of ensuring 
that the swordfish that they offer for import into the United States is 
not adulterated.
    Section 123.11(d) provides an option for those importing from a 
country that has an active memorandum of understanding (MOU) or similar 
agreement with FDA. If the MOU is current, and if there is equivalency 
between the inspection system of the foreign country and the U.S. 
system, the importer will be able to rely on the MOU in lieu of the 
actions required under Sec. 123.11(c). An active MOU must accurately 
reflect the current situation between the signing parties and be 
functioning and enforceable in its entirety. It is the importer's 
responsibility to determine whether the MOU is in fact active, and 
whether it covers the products that the importer intends to receive 
from that country.
    Finally, the agency strongly encourages importers (as reflected in 
proposed Sec. 123.11(e)) to require their suppliers to obtain HACCP 
training such as is required in Sec. 123.9.
    Proposed Sec. 123.12 provides that there must be evidence that 
seafood offered for import has been produced in accordance with part 
123, subpart A. As stated previously, FDA is including this requirement 
to ensure that there is equivalent treatment of imported and domestic 
products. FDA can ensure that domestic product is being produced in 
accordance with the HACCP plan and the sanitation controls in 
Sec. 123.10 through direct observation and review of records. Similar 
inspection of foreign processors would be prohibitively expensive. 
However, FDA tentatively finds that mere reliance on the existence of 
an HACCP plan is not enough, and that additional evidence of compliance 
must be provided. FDA tentatively finds that this evidence can be 
provided by the means listed in proposed Sec. 123.12(a).
    One of the ways that the agency contemplates obtaining this 
evidence would be by inspecting, at the importers' U.S. place of 
business, the importers' and foreign suppliers' HACCP plans, sanitation 
procedures, and records associated with the importers' plans. If these 
records demonstrate that the foreign processor and the importer are 
operating in accordance with adequate HACCP plans, agency will have 
assurance that the food is not adulterated under section 402(a)(4) of 
the act.
    FDA also intends to pursue MOU's with countries that demonstrate 
that their inspection systems are and continue to be substantially 
equivalent to those in the United States (proposed Sec. 123.12(a)(2)). 
The existence of an active MOU between FDA and the country of origin 
covering the seafood products being offered for import will provide 
assurance that these products covered by the MOU are being produced 
under appropriate conditions.
    If there is no MOU, the agency will take into consideration, for 
purposes of verifying the compliance of imported seafood, knowledge 
that a foreign country has an advanced seafood inspection system that 
provides for plans that are HACCP based, as provided in proposed 
Sec. 123.12(a)(3). The existence of such a regulatory system and its 
enforcement will provide assurance about the conditions under which 
products exported from that country are being produced.
    Proposed Sec. 123.12(a)(4) provides that inspection of foreign 
processors by the agency or other organization designated by FDA may 
also be used to establish compliance with these regulations.
    Finally, the agency intends to use other measures as it finds 
appropriate to make determinations about the acceptability of the 
product being offered for import, including but not limited to end 
product testing, as in proposed Sec. 123.12(a)(5).
    If assurances do not exist, as described in Sec. 123.12(a), that 
the product has been produced under an HACCP plan and under sanitation 
controls that are equivalent to those required of domestic processors, 
the agency will deny entry to the products as provided in proposed 
Sec. 123.12(b) because the product will appear to be adulterated (see 
section 801(a) of the act).

I. Raw Molluscan Shellfish

    FDA is proposing to require in part 123, subpart C that processors 
of raw molluscan shellfish include in their HACCP plans how they 
control the origin of the molluscan shellfish that they process. 
Proposed Sec. 123.28 requires that these controls include obtaining raw 
shellfish only from approved growing waters through harvesters or 
processors licensed by a shellfish control authority. FDA is proposing 
to require that processors maintain records to document that each lot 
of raw molluscan shellfish meets these requirements. Under this 
proposal, these records will constitute HACCP records subject to the 
requirements of proposed Sec. 123.8.
    The agency is also proposing to establish a system of tagging or 
other labeling that provides information about the origin of all 
shellstock and shucked molluscan shellfish received by a processor. FDA 
is proposing to amend Sec. 1240.60 (21 CFR 1240.60) to provide for such 
a tagging system.
    Raw molluscan shellfish are molluscan shellfish that have not been 
subject to a treatment sufficient to kill pathogens of public health 
significance. Shellfish that have been subjected to any form of 
treatment, such as steam, hot water, or dry heat, for a short period of 
time before shucking to facilitate removal of the meat from the shell 
are still considered to be raw.
    Molluscan shellfish consumed raw or partially cooked pose unique 
public health risks. They probably cause the majority of all seafood-
related illnesses in the United States (Refs. 6; and 7, p. 330). The 
safety of raw molluscan shellfish directly reflects the cleanliness of 
its aquatic environment. Of all edible species of fish, molluscan 
shellfish are unique in that they are nonmotile, filter feeding 
organisms. They pump large quantities of water through their bodies 
during the normal feeding process (Refs. 7, p. 331; and 90, p. c-4). 
The positive relationship between harvesting areas contaminated by 
sewage pollution and shellfish-borne enteric disease has been 
demonstrated many times (Refs. 7, p. 76; 91 and 92). During feeding, 
the shellfish may concentrate pathogenic microorganisms, deadly toxins 
associated with naturally occurring marine plankton (Ref. 93), or forms 
of agricultural and industrial pollution (Ref. 94). Among the 
pathogenic microorganisms is the Norwalk virus, probably the most 
common cause of seafood-borne illness. This virus commonly occurs in 
waters contaminated by sewage effluent (Refs. 7, p. 76; 91, 92, and 
95).
    Before the adoption of the current public health controls in the 
United States, shellfish commonly transmitted many serious communicable 
diseases. Consumption of raw or undercooked seafood from polluted 
waters can be a mode of transmission for typhoid fever, infectious 
hepatitis, and cholera (Ref. 67). These diseases are still commonly 
associated with raw shellfish consumption in lesser developed countries 
(Ref. 7, p. 73). However, the incidence of these diseases in the United 
States has been largely controlled under section 361 of the PHS Act (42 
U.S.C. 264). This statute was enacted to prevent the introduction, 
transmission, and spread of communicable disease. Under provisions of 
the PHS Act, FDA is empowered to accept assistance from the States to 
protect public health. Accordingly, FDA participates in a Federal/State 
cooperative program called NSSP.
    Established in 1925, the NSSP provides water quality criteria for 
assessing the safety of shellfish growing areas. These criteria are 
applied by the States under the authority of their own laws. The NSSP 
``Manual of Operations'' provides the basis (Refs. 90 and 96) for State 
regulation in 23 shellfish-producing States and 6 nations. Each 
participating State or nation classifies and monitors its shellfish 
growing waters, controls harvesting, inspects shellfish packing and 
shucking facilities, and issues certificates to individual shellfish 
processors that meet the State or foreign government's shellfish 
control criteria.
    To assist themselves in the implementation of their shellfish laws, 
the States have formed the ISSC. The ISSC is an organization of State 
officials, representatives of Federal agencies, and representatives of 
the shellfish industry. It provides guidance to the States and provides 
a forum for them to discuss their problems in attempting to ensure the 
sanitary control of shellfish handling and production (Ref. 97, p. 3).
    FDA evaluates State and international shellfish sanitation programs 
(Ref. 98, part I, p. 2). When it finds that the program is consistent 
with the NSSP, FDA accepts the State's or country's shipper 
certifications. FDA publishes the ``Interstate Certified Shellfish 
Shippers List'' monthly, in which it lists the approximately 2,000 
shellfish dealers that have been certified by participating States.
    While FDA continues to believe in the cooperative partnership that 
it has established with the States, there is evidence that this system 
is not protecting the public health as well as it might (Refs. 7, p. 
331; 99, p. iii; and 100). Problems can originate anywhere. As 
explained in the discussion above of the term ``lot of molluscan 
shellfish,'' the water from which shellfish are harvested plays a 
significant role in determining their safety. If they are harvested 
from unclassified or polluted waters, shellfish can be a vector of 
communicable disease. Problems can also occur as a result of conditions 
under which the shellfish are held on the harvest vessel, in the 
processing plant, or by subsequent handlers or repackers of shucked 
products.
    Given the current situation, FDA has tentatively determined that it 
is necessary for it to take steps to strengthen and provide additional 
support for the existing cooperative program. Thus, FDA is proposing 
two measures.
    First, FDA is proposing to add Sec. 1240.60(b), which will require 
that all shellfish offered for transport or transported in interstate 
commerce bear a tag that lists the date, place, type, and quantity of 
shellfish, and by whom it was harvested, including the harvester's 
identification number. FDA is proposing this requirement because it has 
determined that a tag is the only means by which the agency can ensure 
that it will be possible to determine whether the shellfish have been 
taken from safe water. FDA is proposing to require that the place where 
the shellfish were harvested be listed because it will enable a 
processor who receives the shellfish, or a regulatory official who 
inspects them, to determine whether they were taken from safe water.
    FDA is proposing to require that the date when the shellfish were 
harvested be listed because, as discussed above, the shifting 
conditions in shellfish harvesting waters make shellfish safety 
virtually a day-to-day proposition. Therefore, when the shellfish are 
harvested becomes a critical factor.
    FDA is proposing that the type of shellfish e.g., oysters, clams, 
mussels, or scallops, and quantity be shown on the tag or bill of 
lading to ensure that the tag is applied only to the product to which 
it was initially affixed. Information on type and quantity of shellfish 
describes that product. FDA is proposing to require that the person by 
whom the shellfish were harvested be listed because that person has the 
most direct knowledge of where and when the shellfish were harvested 
and should be readily identifiable in case there are problems with the 
shellfish, so that quick action can be taken to meet the effect of any 
problem.
    Finally, FDA is proposing that the harvester identification number 
issued by the shellfish control authority be included to provide a 
means to confirm the harvester's identity and to obtain the harvester's 
local address in case of an illness investigation or followup to 
tagging and labeling discrepancies.
    FDA is proposing this tagging requirement under section 361 of the 
PHS Act. Under this section, the Surgeon General and, by delegation, 
FDA, is authorized to make and enforce such regulations as in FDA's 
judgment are necessary to prevent the introduction, transmission, or 
spread of communicable disease. FDA tentatively finds that requiring a 
tag is a measure necessary to prevent the spread of communicable 
diseases because the tag will readily permit identification of those 
raw shellfish that were harvested from properly classified waters, and 
thus that will not be vectors of communicable disease in interstate 
commerce, and those that were not harvested from properly classified 
waters and thus that may be vectors of disease.
    Under the PHS Act, FDA is also authorized to provide for such 
measures which in its judgment may be necessary to enforce the 
regulations that it adopts to prevent the spread of communicable 
diseases (section 361(a) of the PHS Act). Therefore, FDA is proposing 
to provide in Sec. 1240.60(b) for the seizure and destruction of any 
shellfish that are not properly tagged. Without the assurances provided 
by the tag, the shellfish may bear a microorganism that may render them 
injurious to health. Thus, they are unfit for consumption and must be 
removed from the food supply.
    FDA recognizes that all shellfish-producing States have laws that 
require the tagging of shellfish. This proposal is intended to support 
those laws, not supersede them. The proposed tagging requirement is 
necessary for two reasons. First, there is no assurance that untagged 
shellfish come from safe waters. Illegal harvesting of molluscan 
shellfish from contaminated or unclassified waters is known to occur 
(Ref. 7, p. 331). It is also known that illegally harvested shellfish 
find their way into commercial channels. States and FDA find untagged 
or improperly tagged shellfish during their inspections of shellfish 
processors under the cooperative program (Refs. 101 through 109). FDA 
frequently lacks a basis for taking action against untagged shellfish 
(Ref. 110). Proposed Sec. 1240.60 will provide a basis. Second, State 
tagging requirements and sanctions are not uniform, and the sanctions 
provided under some State laws have little deterrent effect (Refs. 102, 
103, and 109). The establishment of a Federal sanction will provide 
illegal harvesters with sure knowledge that if their catch enters 
interstate commerce and comes to the attention of FDA, it will be 
destroyed.
    If Sec. 1240.60(b) is adopted, as a practical matter, product 
identification will begin at the harvesting site. FDA is proposing to 
amend Sec. 1240.60 to require that the first handler of live molluscan 
shellfish, be it the licensed harvester, licensed aquaculturist, or 
certified shellfish shipper, affix a tag to each container of 
shellfish. The tag will then provide the means for processors to ensure 
that the shellfish that they buy is from properly classified water.
    Moreover, the tag will provide all information that is necessary to 
trace the product to its source, e.g., date of harvest, location of 
harvest, quantity and type of shellfish, and the harvester's name and 
identification number assigned by the shellfish control authority. The 
product traceability that results will enhance epidemiological 
investigations in the event of shellfish-borne illness. It will also 
facilitate prompt remedial actions necessary to reestablish public 
health controls.
    The safety concerns about shucked molluscan shellfish are 
substantially the same as those discussed above for in-shell molluscan 
shellfish. Because shucked shellfish are packaged in a container that 
can be labeled, the agency is proposing to require in Sec. 1240.60(c) 
that for these shellfish, a label may be substituted that bears 
information equivalent to that found on the tag. Another reason for 
allowing labeling in lieu of a tag is the fact that one bag of 
unshucked molluscan shellfish bearing a single tag can typically be 
processed into more than one container of shucked molluscan shellfish.
    The second measure that FDA is proposing is based on its experience 
with the NSSP and the ISSC. FDA has tentatively concluded that the 
system for protecting the safety of shellfish can be significantly 
strengthened if the agency were to require that certain limited steps 
be taken as part of the processing of shellfish that are intended for 
interstate commerce. FDA believes that these measures, like the 
proposed tagging requirement, will serve to strengthen the Federal-
State cooperative program as well as the shellfish safety programs of 
each of the States and countries that participate in NSSP.
    Many of the pathogens in shellfish, such as the Norwalk virus, are 
virtually undetectable. Moreover, from a technical and practical 
perspective, end product testing cannot be used in the processing of 
shellfish to ensure that they are not contaminated with one of the 
myriad of possible domestic, industrial, and agricultural contaminants 
that have been found in shellfish harvesting areas. Therefore, State 
classification of growing waters is a necessary first step to ensure 
the safety of shellfish. These classifications, as detailed in NSSP, 
address all actual and potential pollutants in deciding whether an area 
is suitable for harvesting (Ref. 90, pp. c-5 and c-6).
    FDA is proposing in Sec. 123.28(a) that each processor of shellfish 
have an HACCP plan that ensures that the molluscan shellfish that it 
processes come only from areas that have been classified by a shellfish 
control authority as satisfactory for harvesting. As noted above, the 
safety of molluscan shellfish consumed raw or partly cooked is 
predicated on the cleanliness of the growing area waters from which 
they are obtained. Ensuring that shellfish come from properly 
classified growing areas is where shellfish safety begins.
    Under proposed Sec. 123.28(b), processors are to process only 
shellfish that originate from growing waters that have been approved 
for harvesting by a shellfish control authority as shown by product 
tags or labels with specific information that establishes that they 
were harvested from appropriate waters. FDA is proposing this 
requirement under both section 361 of the PHS Act, to prevent the 
spread of communicable disease, and sections 402(a)(1), 402(a)(4), and 
701(a) of the act to ensure that the food does not contain any added 
substances that may render it injurious to health and is not prepared, 
packed, or held under insanitary conditions whereby it may be rendered 
injurious to health.
    Under proposed Sec. 123.28(b)(2) and (b)(3), the shellstock tag 
from a licensed harvester or certified processor, or the bill of lading 
accompanying bulk shipments, will contain the information required 
under proposed Sec. 1240.60(b) and thus document whether the shellfish 
are from an acceptable source.
    The proposed requirement Sec. 123.28(b) that only shellfish drawn 
from such acceptable sources can be processed will place a premium on 
properly tagged products from shellfish dealers that States or nations 
that participate in NSSP have certified.
    The agency is further proposing to require in Sec. 123.28(c) that 
shucked products be subject to the same requirements that apply to 
shellstock. FDA is doing so because the safety of shucked shellfish 
products, like shellstock, depends on the quality of the water where 
they are grown. Therefore, the same requirements are needed.
    FDA is further proposing to require in Sec. 123.28(d) that the 
processor maintain records that document that each lot of shellfish 
meets the tagging or labeling requirements in Sec. 123.28 (b) or (c) 
(see Refs. 104 and 108). The information that FDA is proposing to 
require to be maintained in records simply reflects these requirements. 
Permanent records are needed to demonstrate that processors are 
controlling the origin of the shellfish they process. In addition, 
permanent records will facilitate epidemiological investigations by 
allowing complete product traceability to the source of origin.
    The protection of shellfish consumers also requires that domestic 
and imported products be treated equally. While imported raw molluscan 
shellfish are subject to the same standards as domestic shellfish with 
regard to adulteration and misbranding, Federal law does not require 
that imported shellfish come from waters that were classified by a 
public health authority. This double standard is unfair to domestic 
processors, and both ISSC and industry representatives have urged the 
Federal Government to address this problem (Refs. 111 and 112). While 
virtually all States have chosen to reject imported shellfish that are 
not tagged as coming from classified waters (Ref. 113), it is known 
that such shellfish nonetheless enter interstate commerce (Ref. 107). 
Untagged imports originating from uncertified producers compromise the 
effectiveness of seafood safety programs (Ref. 7, p. 73) and product 
traceability. Therefore, FDA is proposing that all raw shellfish 
products either from domestic or foreign origin must comply with the 
requirements in part 123 and Sec. 1240.60.
    Thus, if Sec. 123.28(b), for example, is adopted, it will mean that 
only those molluscan shellfish that are harvested in a foreign country 
that has a program that incorporates the type of measures set out in 
the NSSP for approving growing waters will be appropriate for 
processing. Such a program will need to include measures that provide 
for water classification, monitoring, and other related activities if 
it is to ensure that the growing waters that it approves are safe, and 
thus that the shellfish that are drawn from such waters are not 
adulterated. FDA has found that the best way to establish that a 
foreign country's program meets this standard is through the 
development of an MOU between the agency and that country. Currently, 
such agreements exist with Australia, Canada, Chile, England, Iceland, 
Japan, Republic of Korea, Mexico, and New Zealand.
    In summary, FDA anticipates that these proposed requirements will 
improve the safety of raw molluscan shellfish by establishing uniform 
requirements for domestic and imported products and prohibiting 
interstate movement of shellfish that is not properly tagged to 
demonstrate that it came from an appropriate harvesting area.
    The effectiveness of State shellfish sanitation programs and the 
NSSP will be strengthened by the proposed mandatory tagging, labeling, 
and recordkeeping requirements, which will allow complete product 
traceability to its source of origin. Should illnesses occur, product 
traceability will facilitate a rapid determination of when a problem 
occurred and allow immediate remedial actions to restore public health 
controls. Also, requiring proper tagging or labeling will place a 
premium on State and foreign shellfish sanitation and processor 
certification programs.

J. Guideline for Cooked, Ready-to-Eat Fishery Products

    FDA is proposing a guideline in Appendix A for cooked, ready-to-eat 
fishery products. These products possess an elevated microbiological 
risk relative to most other seafood products because they are cooked as 
part of processing and do not normally receive any additional cooking 
by consumers before consumption. Consequently, to be safe, these 
products must be essentially pathogen-free by the time they leave the 
processing facility. Immediate refrigeration at proper temperatures to 
prevent the growth of pathogens is also essential for these products, 
which are not shelf-stable.
    The guideline addresses critical control points that apply to these 
products as a class and that thus will typically be identified in the 
HACCP plans of most processors of cooked, ready-to-eat products. The 
guideline also addresses ways of controlling hazards at each critical 
control point. Processors of cooked, ready-to-eat products that are 
also smoked and smoke-flavored fishery products should apply the 
controls set forth in Appendix 1. If FDA adopts that regulation, it 
will codify it in reserved subpart B of part 123.
    This guideline is not relevant to most of the cooked, ready-to-eat 
products that are processed as low acid canned foods under part 113. 
However, the recommendations in Appendix A, section 4. a., b., and d. 
for cooling, processing after cooking, and refrigerated storage, will 
apply to those low acid canned foods that are cooked, processed, and 
then cooked again.
    The guideline provides information on how to control the growth of 
S. aureus during the processing step between cooks. It also addresses 
the control of microbiological hazards that can occur within the 
processing environment for cooked, ready-to-eat products. It does not 
address nonprocessing hazards, because they are not relevant to this 
class of products. FDA intends to publish separate guidance that will, 
among other things, address nonprocessing hazards. Likewise, this 
guideline will not address the nonsafety hazards, such as decomposition 
that is not associated with human illness and economic adulteration, 
that FDA has suggested in proposed Sec. 123.6(c) should be covered by 
the HACCP plan. These hazards will also be covered in the separately 
published guidance. Economic adulteration, for example, is addressed in 
Appendix D.
    FDA has tentatively decided to address the processing controls for 
cooked, ready-to-eat products in a guideline, rather than by 
regulation, to permit flexibility in the face of changing processing 
technologies and knowledge. As stated earlier in this preamble, the 
guidelines are intended to advise processors about what FDA believes 
will be acceptable in a HACCP plan. The agency acknowledges, however, 
that there are basic processing norms to which conscientious processors 
adhere, and that these norms are not likely to change for the 
foreseeable future. FDA therefore invites comments on whether any or 
all of the guideline on the cooked, ready-to-eat products ought to be 
codified as requirements in part 123 if it is adopted as a final 
regulation.
1. Thermal Processing: Cooking and Pasteurization Processes and 
Equipment
    The proposed guideline in Appendix A, section 4 advises processors 
on how to ensure that: (1) Their cooking and pasteurization processes 
are adequate to inactivate pathogens; and (2) their cooking and 
pasteurization equipment is adequate to deliver their cooking and 
pasteurization processes. A cooking process is, in essence, the 
temperature and time at that temperature that will both kill pathogens 
and create a marketable product. A pasteurization process is the 
temperature and time at temperature that is necessary to reduce the 
numbers of pathogens to the point where they will not cause harm over 
the shelf life of a refrigerated product. It is essential that C. 
botulinum type E not survive the pasteurization process for cooked, 
ready-to-eat products that are packed in hermetically sealed containers 
and held at refrigerated temperatures (Ref. 52). Such containers are 
typically vacuum or modified atmosphere packaged and thus can provide a 
good environment for the growth of C. botulinum type E.
    To meet the requirements in part 123, subpart A, processors must 
have assurance that their cooking and pasteurization processes are 
adequate to inactivate pathogens and must document this assurance in 
their HACCP records. This approach is similar to that in the 
regulations for low acid canned foods, which require that processors of 
those products know that their thermal processes are adequate to 
destroy C. botulinum. The low acid canned food regulations do not 
specify to processors what their time/temperature parameters must be in 
order to destroy those pathogens. There are simply too many variables 
and possibilities with regard to thermal processing parameters for this 
kind of specificity in those regulations to be practical or 
appropriate. Rather, the regulations require that processors use a 
thermal process that is at least equivalent to one established by a 
competent process authority, i.e., a third party who has the expertise 
to determine the parameters of a thermal process that will destroy 
pathogens (Ref. 85).
    This approach has served the consuming public, the agency, and the 
industry well over the years. FDA is therefore recommending in proposed 
Appendix A, section 4. a.1. and b.1. that processors utilize the 
services of process authorities to establish the parameters of their 
cooking and pasteurization processes.
    A process authority could be a private individual, a member of 
academia, or an agency of government. Processors can find competent 
process authorities through their trade associations, local Sea Grant 
extension offices, or State universities.
    The procedures that are used in establishing a cooking or 
pasteurization process should be generally recognized and accepted. 
Such procedures may include thermal death time, heat penetration, and 
inoculated pack studies, as necessary, to establish the minimum process 
necessary to destroy pathogens. In cases where the cooking process or 
pasteurization process is standardized and not unique to a specific 
processor, articles in journals; Federal, State, or local regulations 
and guidelines; or other appropriate vehicles could provide process 
parameters (Ref. 52). Whatever the source, processors must retain the 
documentation from the process authority that the process will be 
effective as part of their HACCP records, in accordance with proposed 
Sec. 123.8(c).
    The process established by a process authority should include 
values for those aspects of the process that can affect the destruction 
of pathogens. The most notable of these are cooking times and 
temperatures. Others may include the initial internal temperature of 
the cooking medium before the cooking, the product size and species, 
and the viscosity of formulated products such as soups.
    FDA is already aware that the cooking processes necessary to create 
a marketable product for several types of cooked, ready-to-eat products 
are many times more lethal than necessary to inactivate pathogens (Ref. 
114). The products are the several types of crabs listed in the 
guidelines at proposed Appendix A, section 4.a.4. FDA has tentatively 
concluded that, for these products, the adequacy of both the cooking 
process and cooking equipment can be assumed.
    It is likely that other products could be added to this list. The 
agency invites comments on this point. Comments should be accompanied 
by data that will enable the agency to determine that the minimum 
cooking process necessary to achieve a marketable product, e.g., heat 
penetration data and data on the range of cooking processes (times and 
temperatures) applied to that product, will produce a safe product.
    The same general principles also apply to the design of the cooking 
and pasteurization equipment. It is necessary that this equipment be 
designed and operated so that every unit of product receives the 
established minimum cooking or pasteurization process proposed 
(Appendix A, section 4. a.2. and b.2.) (Ref. 85). FDA recommends that 
the equipment be evaluated for design and operation by a process 
authority who is familiar with the dynamics of temperature distribution 
in processing equipment. In some instances, temperature distribution 
studies may be necessary to establish the adequacy of the equipment. In 
other instances, existing literature should be sufficient. Processors 
must obtain and retain documentation that the equipment will provide 
the minimum process as part of their HACCP records in accordance with 
Sec. 123.8.
2. Container Integrity
    The proposed guidelines advise in Appendix A, section 3. c. and d. 
that HACCP plans prepared in accordance with part 123, subpart A will 
normally identify finished product container sealing for pasteurized 
products and postpasteurizing cooling as critical control points. 
Contamination with C. botulinum type E during the postpasteurization 
cooling step is a special food safety hazard that must be controlled 
for pasteurized products. Two potential causes of recontamination are 
poor container seams and contaminated cooling water. Consequently, the 
guidelines, at Appendix A, section 5, recommend controls that 
processors can utilize that are likely to meet the requirements of 
subpart A. Appendix A, section 5.a. advises processors how to inspect 
finished product containers of pasteurized products for container 
integrity to ensure a consistently reliable hermetic seal. At proposed 
Appendix A, section 5.b., the guidelines advise about testing for the 
presence of sanitizer in cooling water.
    Seam inspections should determine whether the seams conform to the 
manufacturer's guidelines. Additionally, because of variations from 
seaming head to seaming head, from closing machine to closing machine, 
and over time for any one machine or head, FDA recommends that 
processors conduct inspections for each machine and head at least every 
4 hours. Visual seam inspections are not adequate to fully assess the 
integrity of the seam. Physical testing and, in the case of double 
seams, seam teardown and measurement, are necessary parts of the 
inspection, as presently required for low acid canned foods in part 
113.
    The presence of sanitizer in cooling water provides a control for 
the risk of microbiologically contaminated water being drawn into the 
can. A vacuum created by a collapse in the cooling vat of the steam 
head in the container, generated during the heating step, can draw in a 
minute amount of cooling water and any pathogens contained in that 
cooling water. Seams are in a particularly stressed condition at that 
time. Sanitizer strength levels should be checked periodically because 
there is a tendency for variation in strength to occur, particularly in 
batch-type systems.
3. Time and Temperature
    The guidelines advise, in proposed Appendix A, section 3. e., f., 
g., and h., that HACCP plans prepared in accordance with subpart A of 
part 123 will normally identify cooling after cooking, processing after 
cooking, final product cooling, and refrigerated storage, as critical 
control points. The potential exists for some pathogenic microorganisms 
to survive the cooking process, regardless of the controls that are in 
place at that step. Likewise, despite a processor's efforts to minimize 
recontamination of the cooked product with pathogens, the potential 
exists for some pathogens to be reintroduced. For these reasons, it is 
imperative that exposure of the product after the cooking process to 
temperatures that permit the growth of pathogens be kept to a minimum, 
since larger numbers are frequently associated with a greater potential 
for disease.
    To control hazards as required by part 123, subpart A, the process 
must take steps to restrict time/temperature abuse of the cooked 
product to the point that pathogens such as Salmonella spp. do not 
enter the rapid (logarithmic) phase of growth. By restricting pathogen 
growth to the slow (lag) phase, pathogen numbers should remain constant 
or increase only slightly.
    Proposed Appendix A, section 6.a. provides a way to control the 
growth of pathogens immediately after cooking. It advises that, after 
cooking, the product should be cooled from 140  deg.F (60  deg.C) to 70 
 deg.F (21.1  deg.C) within two hours. This time/temperature 
combination is based on the upper limit for growth (i.e., 140  deg.F) 
and the lower limit for rapid growth (i.e., 70  deg.F) of such 
mesophilic pathogens as Salmonella spp. and S. aureus, and the typical 
length of the lag phase for the former microorganism (Refs. 23, 85, and 
115). However, 70  deg.F (21.1  deg.C) will not fully control the 
growth of psychrotrophic pathogens. Consequently, further cooling from 
70  deg.F (21.1  deg.C) to 40  deg.F (4.4  deg.C) within 4 additional 
hours is advisable, based on the minimum growth temperatures of such 
psychrotropic pathogens as L. monocytogenes, Salmonella spp., and S. 
aureus, and the lag time of Salmonella spp. (Refs. 23, 78, and 79).
    These cooling recommendations are generally consistent with those 
of the Food Safety and Inspection Service (FSIS) of USDA (Ref. 115) and 
the National Food Processors Association (NFPA) (Ref. 78). FDA invites 
comments on the specifics in App. A, section 6.a.
    In those instances where further processing takes place before the 
achievement of the 70  deg.F (21.1  deg.C) or the 40  deg.F (4.4 
deg.C) temperatures, further reduction in temperature need not take 
place. There is no need for production delays when in-process storage 
times are normally less than the 2 or 6 hours needed to achieve each of 
these temperatures.
    The time/temperature parameters employed to control the 
microbiological hazards associated with cooling after cooking can be 
confirmed by a program of routine time and temperature monitoring 
(Appendix A, section 6.a.1.). Real time documentation of this 
monitoring should be done to facilitate management and regulatory 
review.
    Alternately, the ability of the firm's processing procedures to 
consistently achieve the appropriate time/temperature parameters can be 
confirmed through scientifically conducted time/temperature studies 
that take into consideration the range of processing variations 
encountered at the firm. Examples of processing variations include 
product size, e.g., the range of shrimp sizes that the firm typically 
processes; the temperature of the cooling medium, e.g., the highest 
temperature normally experienced in the firm's cooling unit; and the 
amount of product normally placed in the cooling unit.
    In some instances in-process time/temperature monitoring may be 
impractical or needlessly redundant, particularly in continuous 
processing systems. A scientifically conducted study is especially 
appropriate for such situations, where it can be assured that in all 
plausible situations the time/temperature parameters will be met. 
Documentation and retention of the conduct and results of this study is 
required by Sec. 123.8.
    Appendix A, section 6.b. advises how processors can ensure that 
microbiological hazards associated with postcooking processing can be 
controlled. It advises that products not be exposed to ambient 
temperatures of 40  deg.F (4.4  deg.C) or higher for more than 4 hours 
during postcooking processing, again based on the minimum growth 
temperature of such psychrotropic pathogens as L. monocytogenes and on 
the normal lag phase of such mesophilic pathogens as Salmonella spp. 
The agency recognizes that, for many products, manipulation of the 
product after cooking, while undesirable from the standpoint of 
microbiological recontamination, is necessary for many cooked, ready-
to-eat products. It is often impractical to perform this manipulation 
under refrigerated conditions. Consequently, the product will be 
exposed to some combination of time and temperature that may allow for 
microbiological growth. The recommended conditions will minimize the 
growth of pathogenic microorganisms and the production of heat stable 
toxins (e.g., staphylococcal enterotoxin).
    The ability of the firm's processing procedures to consistently 
achieve its time/temperature parameters can be confirmed by monitoring 
the length of time that the product is exposed to such ambient 
temperatures. Documentation of time/temperature monitoring must be in 
accordance with Sec. 123.8. to facilitate management and regulatory 
review.
    Appendix A, section 6.c. advises how processors can ensure that 
microbiological hazards associated with final product cooling can be 
controlled. Following the manipulation of the product during 
postcooking processing, it will be necessary for the processor to cool 
the product to a temperature that will not support the further growth 
of mesophilic or psychrotropic pathogens. This result can be achieved 
by cooling the finished product to an internal temperature of 40  deg.F 
(4.4  deg.C) within 4 hours of either placing it in the finished 
product container or completing pasteurization. Again, the 
recommendation is based on the minimum growth temperature of such 
psychrotropic pathogens as L. monocytogenes and on the normal lag phase 
of such mesophilic pathogens as Salmonella spp. Of specific concern to 
the pasteurization process is the reduction of the internal temperature 
of the product to a level that will not support the growth of any 
surviving spores of C. botulinum, type E.
    The ability of the firm's processing procedures to consistently 
achieve its time/temperature parameters can be confirmed by a program 
of routine time and temperature monitoring designed to address the 
particulars of the firm's processing system. Real time documentation of 
this monitoring should be done to facilitate management and regulatory 
review.
    Alternately, the firm's ability to consistently meet its parameters 
can be confirmed through scientifically conducted time/temperature 
studies that take into consideration the range of processing variations 
encountered at the firm. Examples of these processing variations 
include container size, the temperature of the cooling medium, and the 
amount of product normally placed in the cooling unit. In many 
instances, in-process time/temperature monitoring may be impractical 
and expensive for sealed finished product containers. A scientifically 
conducted study is especially appropriate in such situations, where it 
can be assured that in all plausible situations the time/temperature 
constraints will be met. Documentation of the conduct and results of 
the study is required under proposed Sec. 123.8 to facilitate 
management and regulatory review.
    Temperature control during refrigerated storage is best achieved 
through the use of temperature indicating and recording devices and 
recordkeeping, as stated in Appendix A, section 6.d.2. (Ref. 85). 
However, FDA recognizes that some processors may desire to manually 
monitor the temperature of the refrigeration unit, using only a 
temperature-indicating device and a logbook. When coupled with a high 
temperature alarm or a maximum-indicating thermometer, the agency feels 
that this practice represents an acceptable alternative.
    The guideline advises, in Appendix A, section 3.i., that HACCP 
plans prepared in accordance with subpart A of part 123 will normally 
identify distribution as a critical control point. Distribution of 
perishable products encompasses the same hazards as associated with 
refrigerated storage. For this reason, in Appendix A, section 6.e., the 
agency is recommending a critical limit of an internal temperature 
maximum of 40  deg.F (4.4  deg.C) and is encouraging the shipper and 
consignee to arrange for appropriate control measures.
    The agency recognizes that distribution patterns vary considerably 
from single shipments to pooled and multiple delivery shipments, from 
iced shipments to refrigerated shipments, and from shipments on the 
consignee's truck to shipments on the shipper's truck to common carrier 
shipments. Each mode presents different opportunities and impediments 
for control.
4. Temperature Monitoring Equipment
    Processors must monitor and control the temperature of their 
refrigeration units in order to ensure that microorganisms of public 
health concern do not increase in numbers. Likewise, processors must 
control the times and temperatures of their thermal processes in order 
to ensure that the minimum thermal process is consistently delivered to 
the product. The guidelines address the outfitting of cooking, 
pasteurization, and refrigeration equipment with temperature indicating 
and recording devices (Appendix A, sections 4. a.2.ii. and b.2.ii., and 
section 6.d.2., respectively). A temperature-recording device provides 
a complete history of the temperature throughout the thermal process by 
continuously recording it on a chart. As has been demonstrated for low 
acid canned foods, the chart itself provides an excellent HACCP record 
for the benefit of both processor and regulator. For this record to be 
meaningful, it is critical that the temperature-recording device sensor 
be installed so as to accurately represent the temperature of the 
heating or cooling medium.
    Temperature-recording devices are easily jarred and rendered 
inaccurate. They can be calibrated and corrected against a temperature-
indicating device (e.g., a thermometer) quite easily, however. 
Processors should do so at least at the beginning and end of each 
production day in order to determine whether the instrument was 
accurate throughout the day's production. In this situation, the 
temperature-indicating device serves as reference instrument since it 
is much more reliable. Consequently, the temperature-recording device 
should never show a higher temperature than the temperature-indicating 
device.
    Temperature-indicating devices are generally reliable and need only 
be calibrated upon installation and annually thereafter. Calibration 
should be against a standardized (i.e., traceable to the National 
Bureau of Standards) thermometer that is not subject to the rigors of 
the processing environment (Ref. 85). Temperature-indicating devices 
must often be read under less than ideal plant conditions, so they 
should be installed in a location that facilitates easy reading. As 
with the temperature-recording device, the sensor on the temperature-
indicating device should be installed so as to accurately represent the 
temperature of the heating or cooling medium.
5. Corrective Actions
    Appendix A, section 8. advises processors about corrective action 
steps that they should consider to comply with the proposed corrective 
action requirements in Sec. 123.7 of subpart A. Because the evaluation 
of critical limit failures relating to the cooking step and the 
terminal heat treatment step of cooked, ready-to-eat products may well 
require an understanding of the technical aspects of thermal process 
calculations, Appendix A, section 8. recommends additional controls to 
those required by Sec. 123.7 in this regard. Of primary importance is 
the recommendation that any corrective action other than processing to 
eliminate the hazard or destruction must be assessed by a competent 
process authority. For this purpose, a process authority may be a 
representative of the firm or may be an outside source, so long as the 
process authority has a scientific background that is adequate to make 
the assessment.
6. Sanitary Zones
    Section 123.10 of subpart A establishes requirements for all 
processors for sanitation within the processing environment. In 
addition to these requirements, this guideline recommends in Appendix 
A, section 8. that processors of cooked, ready-to-eat products 
establish sanitary zones in their facilities. The agency invites 
comments on the merits of this concept and on whether it should be 
codified in the regulations.
    The importance of good sanitation in the processing of cooked, 
ready-to-eat products cannot be overemphasized. While, as has been 
stated earlier, plant sanitation has no real bearing on human food 
safety for many foods, the safety of cooked, ready-to-eat products can 
be easily jeopardized by pathogens that are introduced through poor 
sanitation practices. Consequently, FDA is recommending that processors 
establish sanitary zones around areas where products that have already 
been cooked are being handled or stored. The primary purpose of a 
sanitary zone is to physically separate insanitary objects from cooked 
products. Sanitary zones can also minimize the likelihood of airborne 
contamination through proper filtration and positive air pressure in 
the zone.
    A sanitary zone is a separation of operations by location, 
partition, air flow, or enclosed systems. In most cases, it requires 
procedural changes to minimize the risk of contamination but not large-
scale structural changes. Canada has successfully incorporated the 
concept of sanitary zones for seafood processing as part of its HACCP-
based inspection program (Ref. 116).

K. Guideline For Scombroid Toxin Forming Species

    FDA is proposing a guideline in Appendix B for handling of the 
species in which scombroid toxin can form. This problem is primarily, 
but not exclusively, associated with members of the family Scombridae. 
The fish involved contain significant levels of naturally occurring 
free histidine in their flesh, which certain bacteria can decarboxylate 
into histamine. Significant histamine levels occur when the fish are 
exposed after death to times and temperatures that permit the growth of 
these bacteria. Histamine can result in a mild to severe allergic 
response in humans. Scombrotoxin poisoning is one of the three most 
common seafood-related illnesses (Ref. 5, p. 24). The scombrotoxic 
species that have been associated with foodborne illness include tuna, 
bluefish, mahi, mackerel, sardines, herring, kahawai, anchovies, and 
marlin.
    This HACCP guidance is intended to maximize the use of controls to 
ensure proper handling of scombrotoxic species and thus to minimize the 
possibility of a problem. It also recognizes the often complex pathways 
of movement and ownership through which such fish may pass. Failure to 
ensure safe handling at any point in the chain may render the fish 
injurious to health.
    There is a basis for concern about the safety of the fish as soon 
as histamine begins to form. Once the histamine-forming process has 
begun, it is like a chain reaction. Lowering the temperature of, or 
freezing, the fish will slow or arrest the process, but only cooking 
and prevention of recontamination can stop it (Refs. 9 and 117).
    The guideline describes a HACCP system that emphasizes reliance 
upon accurate recordkeeping to show continuity of proper handling. 
Accurate knowledge of the time/temperature history of the fish is very 
important in determining the likelihood that the fish are unsafe or may 
become unsafe. The guideline also calls for more stringent processor 
controls to be applied to lots for which records are inadequate. While 
this guideline is designed to prevent problems, nothing in it should be 
construed as meaning that the agency will not take regulatory action if 
it finds decomposed fish.
    The guideline in Appendix B, section 2. identifies receipt of raw 
materials, which include imported shipments, as a critical control 
point for processors of scombroid toxin forming species. Time/
temperature abuse by the fisherman can result in decomposition and the 
resultant production of histamine.
    Decomposition can also occur before the fish are removed from the 
harvest water if the fish dies in capture nets or on long lines. In 
such an event, the degree of decomposition will reflect the sea 
temperature, time in the water, and particular species (Ref. 118). It 
is not uncommon to encounter water temperatures of 80  deg.F to 90 
deg.F in tropical waters, which can produce rapid decomposition.
    Thus, rapid cooling of fish when they are captured is very 
important to prevent initiation of the process by which histamine is 
produced. Fish subjected to 68  deg.F for periods as short as one day, 
a practice which can happen in warm climates on fishing vessels, will 
yield high levels of histamine, even if the fish are later stored at 
refrigerated temperatures (Ref. 117).
    For these reasons, the guideline advises that processors of fish 
and fishery products from scombroid toxin forming species must ensure 
that their raw materials are essentially free of decomposition and 
histamine as a result of time/temperature abuse that occurred before 
the processor received them. The guideline provides for three 
interrelated controls for the processor to apply with regard to raw 
materials. For the first processor that takes ownership after harvest, 
these are: (1) Time/temperature records from the harvesting vessel 
(Appendix B, section 3.a.1.); (2) organoleptic examination of the fish 
from the harvesting vessel for decomposition (Appendix B, section 
3.a.2.); and (3) histamine analysis, if warranted by the time/
temperature history of the fish as revealed by the time/temperature 
record from the vessel or by the results of the organoleptic 
examination (Appendix B, section 3.a.3.), or both. Time/temperature 
records from the vessel indicate whether entire lots from the vessel 
may be suspect, and thus in need of a histamine examination, because of 
unusual events on the vessel. Such records would not normally reveal, 
however, whether there are individual fish in the lot that may have 
decomposition. An organoleptic examination for decomposition serves to 
screen individual fish. It also serves as a way to verify the time/
temperature records from the vessel with regard to an entire lot. If 
organoleptic examination reveals an unusually high number of fish with 
decomposition, the entire lot should be considered suspect and 
subjected to histamine analysis.
    Appendix B, section 3.a.1. provides for how the first processor can 
take measures to determine whether the fish were properly harvested and 
handled on board the harvesting vessel. Certification of the mode of 
capture, including information on the time between physical capture and 
bringing the fish on board, handling techniques, and the use of 
temperature logs onboard the vessel that record that time/temperature 
history of the fish (for example, catch date and time, means and rate 
of cooling, storage temperature, and refrigerated brine or seawater 
temperature) provide documentation to the processor and to regulatory 
authorities that the fish were properly handled. Such records on the 
handling of the fish should be part of an HACCP system and can be used 
in the specific HACCP plans of processors.
    The harvester's goal should be to bring the fish to an internal 
temperature of 40  deg.F (4.4  deg.C) or below as soon as possible 
after the fish dies to minimize the risk of histamine production. 
Cooling fish below 59  deg.F (15  deg.C), and preferably below 50 
deg.F (10  deg.C), greatly reduces the growth of populations of the 
bacteria that are most likely to cause histamine formation (Ref. 7, p. 
95). Once bacterial growth has begun, temperature at or below 41  deg.F 
(5  deg.C) halts bacterial growth, although enzymatic histamine 
formation may slowly continue (Ref. 7, p. 95). Consequently, in 
proposed Appendix B, section 3.a.1., the agency is recommending a 
slightly lower flesh temperature of 40  deg.F (4.4  deg.C) or below. 
This temperature is consistent with recommendations of safe 
temperatures in other sections of the proposed regulation. Nonetheless, 
FDA specifically invites comments on the appropriateness of this 
temperature.
    Appendix B, section 3.a.1. recommends that the time/temperature 
history from the vessel be on a lot-by-lot basis and defines a lot as a 
discrete storage compartment on the vessel in keeping with industry 
practice. A lot typically reflects a day's catch. Because a boat's 
catch can be subject to varying conditions and treatment from day-to-
day, the time/temperature records should be specific to each lot.
    If the time/temperature records suggest that, for a particular lot, 
the conditions on the vessel were likely to cause, or significantly 
contribute to, the formation of histamine in the fish, or if no 
adequate time/temperature records exist for that lot, the guideline 
provides that a representative sample of fish from the lot be analyzed 
for histamine Appendix B, section 3.a.2.ii.B.). The samples should be 
collected on a statistically valid sample schedule because variations 
in time/temperature abuse are likely at various points in a ship's 
hold.
    The second control, organoleptic examination by the processor for 
decomposition, should be performed regardless of what the time/
temperature records show (Appendix B, section 3.a.2.). First, 
decomposition is a form of adulteration under 403(a)(3) of the act. 
Second, as indicated earlier, an organoleptic examination provides a 
screening mechanism for individual fish. It is possible for the 
conditions on the vessel to be good but for some fish to develop 
decomposition anyway. Third, also as stated earlier, an examination for 
decomposition provides a way to verify the time/temperature records.
    FDA recognizes that an organoleptic examination of each fish can be 
highly impractical. Consequently, the guideline calls for an 
examination of a representative number of fish to achieve a 95 percent 
certainty that the total number of fish in the lot that exhibit 
decomposition does not exceed 2.5 percent. (The significance of 2.5 
percent is addressed in the preamble discussion of Appendix B, section 
3. a.2.iii. and a.2.iv.) Using this approach, the number of fish 
examined will be reasonably close to the total number of fish, so that 
the goal of screening individual fish is preserved to the maximum 
extent practicable. Additionally, FDA expects that this representative 
sample will be large enough so as to provide a sufficient verification 
of the time/temperature records for the entire lot.
    Appendix B, section 3.a.2.i. provides that no fish flesh that 
exhibits any organoleptically detectable decomposition should be used 
for food. Aside from the clear violation of 402(a)(3) of the act 
presented by such decomposition, the public health risk presented by 
decomposition in scombrotoxin forming species is unacceptable. While 
the existence of decomposition does not mean that scombrotoxin is 
present, it does mean that a process has begun that can lead to the 
presence of scombrotoxin over the shelf life of the fish or fishery 
product.
    In some instances, e.g., large fish such as tuna, isolated parts of 
the fish will exhibit decomposition but other parts will be free of 
decomposition. FDA recognizes that it is possible to remove those parts 
of a fish that have decomposition and salvage the remainder. Appendix 
B, section 3.a.2.i. provides for such reconditioning so long as a 
histamine examination is performed on the flesh that is free of 
decomposition. FDA believes that a histamine test is prudent under such 
circumstances to verify that scombrotoxin forming processes are not at 
work in that flesh.
    The guideline also provides for how the processor should use 
organoleptic examination and time/temperature records in tandem to 
determine whether fish or fishery products from scombroid forming 
species are fit for further processing or should first be subject to a 
histamine examination. If no decomposition is found, and the time/
temperature records show that conditions on the vessel were unlikely to 
cause, or significantly contribute to, the formation of histamine in 
the fish, all the fish from that lot may be further processed or 
directly entered into commerce (Appendix B, section 3.a.2.ii.). If, as 
stated earlier, the time/temperature records are inadequate or indicate 
conditions that could cause histamine, the processor should always 
conduct a histamine analysis on a representative sample regardless of 
the decomposition findings.
    If decomposition is found in less than 2.5 percent of the lot, and 
the time/temperature records show that conditions on the vessel were 
unlikely to cause, or significantly contribute to, the formation of 
histamine in the fish, Appendix B, section 3.a.2.iii. provides that the 
decomposed fish should be removed in accordance with the procedure 
outlined in Appendix B, section 3.a.2.i., but that it is not necessary 
to subject the lot to a histamine examination. The agency has 
tentatively concluded that decomposition below 2.5 percent is not 
significant in terms of the acceptability of the entire lot. Under the 
best conditions, it is possible that some fish in a large lot will 
experience some minimal decomposition. Under these circumstances, so 
long as the fish with decomposition are culled from the lot, there is 
no reason to suspect that the lot has been subject to unusual 
conditions that could cause histamine or scombrotoxin to form. The 
agency is aware that the canned tuna industry uses the 2.5 percent 
value to determine whether special handling of a lot is warranted (Ref. 
119). The canned tuna industry has concluded, just as FDA tentatively 
concludes, that levels above 2.5 percent represent likely exposure of 
the fish in a lot to conditions that are out of the ordinary and 
potentially dangerous.
    For these reasons, if the processor finds decomposition in more 
than 2.5 percent of the fish from a lot, those fish must be removed 
from the lot, and a histamine examination needs to be performed on a 
representative sample of the remaining fish in that lot (Appendix B, 
section 3.a.2.iv.).
    It is important to recognize that where the time/temperature 
records are inadequate for all the fish on a vessel, or show poor 
conditions for all the fish from a vessel, histamine analyses should be 
performed on representative samples from each lot on the vessel. 
Although an appropriate number of fish for sampling could possibly be 
provided from a single lot, the results would not be representative of 
the vessel as a whole.
    Appendix B, section 3.a.3. describes how fish should be disposed of 
depending on the results of a histamine examination. In keeping with 
current policy, the agency expects that any fish that is found to have 
histamine above a defect action level or other regulatory level or 
limit for histamine established by FDA will not be used for food. 
Moreover, the agency expects, as reflected in Appendix B, section 
3.a.3.i., that a finding of histamine over such level or limit in any 
fish in a lot from the vessel will result in the destruction of that 
entire lot, regardless of the percentage of decomposition that was 
organoleptically detected or the conditions on the vessel as indicated 
by the time/temperature records. Such a histamine finding strongly 
indicates that neither the records from the vessel nor the 
decomposition test (if the results were below 2.5 percent) are 
reliable. Histamine may be present in the absence of organoleptically 
detectable decomposition.
    Similarly, the agency expects, as reflected in Appendix B, section 
3.a.3.ii., that a finding of histamine below the action level, but 
higher than is normally found in fresh fish (Refs. 120 and 121), in any 
fish in a lot will result in the immediate cooking of all the fish in 
the lot to ensure that scombrotoxin will not form over the shelf life 
of the fish. Cooking stops the histamine forming process once it has 
started. Without this cooking, any elevated temperatures later in the 
distribution system or in the home can result in a rapid elevation of 
histamine levels to hazardous levels (Ref. 117, p. 341).
    Appendix B, section 3.b. addresses raw materials controls that can 
be exercised by subsequent processors, i.e., those other than the first 
processor to take possession of scombroid toxin forming fish and fish 
products from a harvester. Assuming that the first processor has met 
its responsibilities with regard to raw materials as explained above, 
and has not caused a problem through improper handling during 
processing, subsequent processors should determine whether 
decomposition occurred during transfer from the previous processor. 
Consequently, the guideline provides, at Appendix B, section 3.b.1., 
that subsequent processors that do processing other than simply 
storing, should subject a representative sample of fish or fish 
products from each lot to an organoleptic examination. Any finding of 
decomposition in that sample should lead to organoleptic examination of 
the entire lot. If decomposition is found in more than 2.5 percent of 
the fish in the lot, the processor should perform a histamine 
examination on a representative sample of fish from the lot. These 
gradations are consistent with the expectations reflected in the 
guidelines for first processors.
    FDA has tentatively concluded these measures need not be taken by 
those who only store fish and fishery products. While time/temperature 
abuse can occur during storage, and thus scombroid toxin forming 
species must be  held  at  appropriate  temperatures (40  deg.F (4.4 
deg.C) or below), the hazard of scombrotoxin in the finished product 
can be controlled by those who own the product or manipulate it during 
processing.
    As suggested above, time/temperature abuse can occur during 
processing as well as before the raw materials are received. It is 
important that processors identify critical control points and suitable 
controls that will protect fish and fish products that can form 
scombrotoxin from time/temperature abuse. As the guideline for 
scombrotoxin states in Appendix B, section 5., many of the controls for 
time and temperature in the guideline for cooked, ready-to-eat products 
should be applicable to the processing of scombrotoxin forming species. 
Such handling conditions are necessary to control histamine production. 
In addition, Appendix B, section 4. provides that products that are 
undergoing processing not be exposed to ambient temperatures of 40 
deg.F (4.4  deg.C) or higher for more than 4 hours during that 
processing. The agency recognizes that for many products, manipulation 
under unrefrigerated conditions is necessary. The processor must be 
aware, however, that during such periods the product will be exposed to 
conditions that can lead to histamine formation. Appendix B, section 4. 
describes how to minimize this possibility.
    To comply with Appendix B, section 4., the processor should monitor 
the length of time that the product is exposed to ambient temperatures 
of 40  deg.F or higher. Documentation of the time/temperature 
monitoring controls will facilitate management and regulatory review.

L. Guideline for Product Integrity

1. Economic Adulteration
    Economic adulteration occurs when a consumer is misled about the 
worth, amount, or identity of a food product and, therefore, 
unknowingly pays for value not received. Economically deceptive 
practices in the representation of a food's value may occur in a number 
of ways. Sections 402(b) and 403 of the act define the conditions and 
practices that result, respectively, in the economic adulteration and 
misbranding of a food. In addition, the Fair Packaging and Labeling 
Act, 15 U.S.C. 1451 et seq., requires that food packages and their 
labeling provide consumers with accurate information about the identity 
and net quantity of the contents, so that consumers can make fair value 
comparisons among products.
    While any food may be subjected to economic adulteration or to 
misbranding, fish and fishery products present distinctive 
characteristics and processing procedures that make them more 
susceptible to abusive economic practices than most foods. The great 
variety of finfish, shellfish, and crustacean species, as well as the 
multiplicity of products prepared from them, including fabricated 
surimi-based products that imitate actual seafoods, provide ample 
opportunity for both inadvertent and deliberate economic adulteration 
and misbranding practices that result in economic loss to the consumer.
    Most important among the characteristics that make seafoods 
vulnerable to abuse is the similar appearance of many finfish, in the 
whole, raw state, in the form of fillets, or as ingredients. Unlike the 
situation with the limited types of red meats and fowl, it is very 
difficult for most consumers to detect the substitution of an 
economically inferior species for a more valuable one that is declared 
on the label or in labeling (e.g., the substitution of rockfish for red 
snapper).
    Irrespective of the relative economic value of the substitute 
species, section 403(a)(1) of the act states that a food shall be 
deemed to be misbranded if its labeling is false and misleading in any 
particular. More specifically, a food is misbranded under section 
403(b) of the act if it is offered for sale under the name of another 
food. If the substituted fish is less valuable than the species 
represented on the label or labeling, the product is also adulterated 
under section 402(b)(2) of the act, which states that a food shall be 
deemed to be adulterated if any substance has been substituted wholly 
or in part therefor. Consequently, it is a clear violation of the act 
when a finfish, shellfish, or crustacean is not correctly identified on 
its label or in its labeling.
    Furthermore, the misidentification of species may also have adverse 
public health consequences. Should an illness or outbreak occur from a 
seafood product, it is essential for proper diagnoses and treatment 
that public health investigators not be prevented from quickly 
identifying the exact cause or agent responsible in the food, and from 
tracing it back to the correct source of the food to prevent further 
sale and consumption.
    For example, in a seafood related incident that occurred in 1982, 
in New York, two men became ill shortly after eating a fish dinner in a 
restaurant. Species substitution caused investigators to erroneously 
suspect that the illnesses were caused by ciguatoxin because the food 
was identified as being red snapper, a species which could cause that 
illness. The food actually was mahi, a fish which is often associated 
with scombroid poisoning (Ref. 122). Scombroid poisoning is associated 
with high levels of histamine.
    FDA found that the fish mislabeled as red snapper had been shipped 
from Ecuador and processed in Panama. Had the fish been labeled as 
mahi, it would not have been permitted entry into the United States 
because FDA had an automatic detention for mahi from Ecuador at the 
time because of problems with high levels of histamine.
    Another instance involving species substitution resulting in a 
negative public health consequence occurred in Hawaii in 1987. Fifty 
illnesses, 32 of which required medical attention, were attributed to 
the consumption of limpets misbranded as ``Baby Abalone.'' The symptoms 
displayed were those of a histamine-type reaction. Because abalone is 
not one of the species expected to form histamine, substituting limpets 
for abalone put consumers at risk from a food that they had not 
intended to eat. Thus, accurate identification of species is essential 
to public health protection and prompt accurate diagnosis and treatment 
of illness when that protection fails.
    Processing practices traditionally used in the seafood industry 
also are easily abused to increase a product's weight, in the form of 
ice or water. For instance, frozen fillets, shrimp, crab legs, and 
other products are normally protected from dehydration (freezer burn) 
while frozen by the application of a light glaze of ice. A packer then 
includes added product in the package to compensate for the weight of 
the glaze. Excessive amounts of glaze, however, not compensated for in 
this manner, can deliberately be used to increase the apparent weight, 
and therefore the apparent value, of the product delivered. Percentage 
weight increases from overglazing are most dramatic for foods with high 
surface area to volume ratios, such as shrimp. Overglazing is a 
practice that violates section 402(b)(4) of the act because a substance 
has been added to increase a food's weight or to make it appear of 
greater value than it is.
    A similar type of fraud frequently results from oversoaking fish 
and shellfish meats in dip solutions. Dip solutions are customarily 
used to retard the natural loss of moisture (drip loss) from products 
such as scallops, which are particularly susceptible to drip loss. 
However, exposure to the dip may deliberately be prolonged to add 
weight in the form of water. Dip solutions may contain chemicals, such 
as sodium tripolyphosphate, that can greatly enhance the amount of 
water absorbed by the scallops. The net effect of such practices is to 
mislead the consumer into purchasing added water at scallop prices.
    Seafoods generally represent a high dollar value per unit weight 
compared with other foods, particularly crab, lobster, shrimp, and 
certain shellfish. Thus, even relatively modest percentage weight 
increases from abusive glazing or water uptake from dip solutions 
represent a substantial loss of value to the consumer.
    For the same reason, the potential fraudulent profit from similar 
practices of adding less valuable ingredients, such as breading on 
shrimp and fish sticks or water to shucked oysters, to increase the 
size or weight of products are enticing to unscrupulous processors.
    The agency believes that economic adulteration occurs with 
sufficient frequency in various seafood products to result in 
substantial losses to the consumer. Evidence of such economic 
adulteration usually comes to light indirectly, as a result of 
investigations that are carried out for other purposes.
    Fourteen and one-half percent of the samples of seafoods reported 
in 1986 as having adverse findings by eight FDA district offices were 
so listed because of product misrepresentation (Ref. 123).
    Similarly, FDA found that in fiscal years 1991 and 1992, 14.8 and 
11.7 percent, respectively, of all consumer complaints involved 
complaints of economic problems (Ref. 60).
    Imported seafood products also are subject to significant levels of 
economic misrepresentation. In 1992, approximately 13 percent of all 
detentions of imported seafood involved some form of misbranding, such 
as false or misleading labeling, short fill, short weight, standard of 
identity, and omitted labeling (Ref. 124).
    Specific data on species substitution are available from The 
National Seafood Inspection Laboratory (NSIL) of NMFS, Department of 
Commerce. Data gathered for the 3-year period of 1990-1992 by the 
laboratory in conducting species verification tests requested by 
industry show that 59 percent of the samples labeled as cod, 57 percent 
of the product labeled as haddock, 56 percent of the product labeled as 
flounder or sole, and 51 percent of the product labeled as red snapper 
were not the species claimed on the label. While these data cannot be 
regarded as representative of industry-wide misbranding practices 
because the testing was not random, the results indicate a remarkably 
high incidence of species substitution. Moreover, these findings are 
consistent with other surveys (Ref. 35, p. 45).
    For example, a survey conducted in Florida to determine the extent 
of retail species substitution in the case of red snapper found that 64 
percent of the fish fillets labeled for retail sale as red snapper were 
misbranded (Ref. 125). The prevalence of misbranding just this one 
desirable species is underscored by the observation: ``If all of the 
red snapper sold in the United States were genuine, the seas would long 
since have been swept absolutely clean of this species'' (Ref. 126, p. 
41).
    While most States' regulations follow FDA nomenclature policy and 
regulations, misbranding practices are exacerbated by the failure of 
some States to require these common names for some species sold within 
the State. Red snapper again provides a case study in the extent of 
variation in acceptable nomenclature allowed for a species. Although 
not permitted when sold in interstate commerce, California regulations 
allow 12 species of rockfish to be labeled as ``Pacific red snapper'' 
within the State. Similarly, Oregon and Washington regulations also 
allow rockfish to be called ``snapper'' (Ref. 126, p. 305). Moreover, 
an even greater variety of imported species may be misrepresented as 
``red snapper.''
    Many in the seafood industry believe that economic abuse is one its 
most significant problems. A survey conducted by the National Fisheries 
Institute found that the Institute's membership supported mandatory 
inspection as a means of overcoming practices that pose a threat to the 
reputation of processors and packers adhering to scrupulous practices 
in the representation of their products (Ref. 127). General agreement 
was found to exist among processors, distributors, and importers, as 
well as retailers and restaurateurs, that abusive economic practices 
are widespread, including overglazing and overbreading of fishery 
products, inaccurate net weight measurement, and the substitution of 
inferior species for more valuable fish.
    In a similar industry study by the Southeastern Fisheries 
Association, members ranked problems with economic fraud (such as 
species identification, overglazing, and the use of phosphates) above 
all other seafood industry problems, except vessel handling practices 
(Ref. 128).
2. Recommended Adoption of HACCP-Based Methods
    Although the agency recognizes that HACCP was developed primarily 
to address safety, FDA believes that the proposed requirement in 
Sec. 123.6, for seafood processors to adopt HACCP methods to ensure the 
safety of seafoods provides an opportunity for processors to develop 
and apply effective control point procedures that they can use to 
ensure that seafoods comply with the provisions of sections 402(b) and 
403 of the act, The Fair Packaging and Labeling Act, the seafood 
standards of identity promulgated in 21 CFR, and applicable compliance 
policy guides issued by the agency (Compliance Policy Guides 7108.01, 
7108.03, 7108.04, 7108.12, 7108.13, 7108.14, 7108.21, and 7108.23). 
Consequently, the agency is proposing in Appendix D to establish a 
guideline for HACCP-based procedures to avoid economic adulteration and 
misbranding of seafoods. Following this guideline will enable 
processors to develop procedures and records that will establish that 
they are not engaged in any practices that would render their products 
economically adulterated. Clearly, however, guidelines cannot prevent 
economic fraud.
    The following guideline for product integrity lists critical 
control points covering raw material receipt, processing, and labels 
and labeling that processors and importers can incorporate in their 
HACCP plans. The agency believes that proper control begins with 
verification of the raw materials received by a processor. Therefore, 
in Appendix D, section 2.a., the agency is suggesting that, as part of 
their HACCP plan, processors and importers should include critical 
control points beginning with the receipt of raw materials. Ensuring 
that raw materials meet critical limits (e.g., correct species 
identification, net weight, additive identification) at the point they 
enter a processor's or importer's control is crucial.
    There are a number of ways to ensure that species are properly 
identified. Physical examination, as indicated in Appendix D, section 
2.a.1. is the typical method of determining the identity of a species. 
The agency believes that most seafood processors and importers are 
knowledgeable about the species that they handle and would have 
personnel available at the point of receipt who could monitor the 
incoming shipments for species substitution. Expert consultation is 
another option for correctly identifying species.
    Processors or importers can also check the identity of seafood by 
employing laboratory services, as provided for in Appendix D, section 
2.a.2. Protein chromatography is a laboratory method that can 
accurately establish the species of fish and fishery products (Ref. 
50). Another option, Appendix D, section 2.a.3., is to receive raw 
materials certified by suppliers under either limited or general and 
continuing guaranties (section 303(c)(2) of the act (21 U.S.C. 
333(c)(2)) and 21 CFR 7.12 and 7.13).
    In Appendix D, section 2.b., the agency points out that processors 
must ensure that the labels, labeling, and invoices of their finished 
products accurately list weight, count, size, and product identity, as 
well as the content of valuable constituents (i.e., that ingredient 
that the consumer identifies as providing the reason to purchase the 
product, for example, the shrimp in breaded shrimp). The content of the 
valuable constituents must be maintained as required by FDA's standards 
of identity regulations (21 CFR part 161, including: oysters, Pacific 
salmon, canned wet packed shrimp in transparent or nontransparent 
containers, frozen raw breaded shrimp, frozen raw lightly breaded 
shrimp, and canned tuna) or in accordance with FDA's compliance policy 
guides.
    More specifically, as in Appendix D, section 2.b.1., the species 
must be correctly identified by its common or usual name and be so 
represented on the label and labeling. To assist processors and 
consumers, FDA has developed both printed and database versions of the 
``FDA Fish List'' to provide such guidance. Also specific requirements 
for such labeling are listed in Standards of Identity and the Common or 
Usual Name regulations (21 CFR, parts 161 and 102).
    Appendix D, sections 2.b.2. through b.5. are based on section 
402(b) of the act. Under Appendix D, section 2.b.2., the processor 
needs to ensure that valuable constituents of the product are not 
omitted or abstracted. For example, breaded shrimp must contain the 
required weight ratio of shrimp to breading. Similarly, shrimp must be 
of the size and/or weight specified on the label or labeling.
    Under Appendix D, section 2.b.3., the processor needs to ensure 
that no substance is substituted wholly or in part for a valuable 
constituent. For example, substitution of crab flavored surimi cannot 
be used in whole or in part instead of crab meat in a product labeled 
as crab cake.
    Under Appendix D, section 2.b.4., the processor needs to ensure 
that damage or inferiority is not concealed in any manner. This means, 
for example, that bleaching or coloring of product to conceal its true 
nature or condition of wholesomeness is not acceptable.

M. Additional Guidance--FDA Fish and Fishery Products Hazards and 
Controls Guide Including Specific Guidance on Smoked Fishery Products

    As an adjunct to its rulemaking to require HACCP procedures in the 
seafood industry, FDA is drafting an extensive guidance for processors 
to use in understanding and implementing HACCP principles for their 
operations. This guidance will provide information that processors and 
importers can use in the development of their HACCP plans. This 
information consists largely of an identification of hazards that can 
affect the safety of seafood and a review of control measures that can 
keep the hazards from actually occurring, or that can at least minimize 
the likelihood of their occurrence.
    FDA has included selected portions of the draft HACCP guidance as 
Appendix 1 to this proposal, so as to better inform the public about 
how this guidance will be structured and about the kinds of assistance 
that will be available to processors and importers who implement HACCP. 
The agency emphasizes, however, that this guidance is a work-in-
progress and still being developed by FDA. Nonetheless, the agency 
seeks comment on the need for this guidance and the usefulness of the 
format the agency proposes to adopt.
    In addition, FDA is including in Appendix 1 specific guidance on 
time-temperature and salinity parameters and other matters for use in 
the HACCP plans of processors of smoked and smoke-flavored fishery 
products. While FDA is seeking comment on the guidance generally, it 
particularly seeks comment on the guidance on smoked and smoke-flavored 
fishery products. Material relevant to the safe processing of smoked 
and smoke-flavored fishery products is found in various sections of the 
HACCP guidance because this general guidance is primarily organized by 
hazard rather than by commodity type. However, the agency has gathered 
the materials relating to smoked and smoke-flavored fishery products 
into a single section of the guidance to facilitate use of this 
guidance by this industry, and to facilitate obtaining public comment 
on it. As stated above, FDA seeks public comment on the appropriateness 
of the materials relating to smoked and smoke-flavored fishery products 
as guidance, on their validity as guidelines, and on whether they 
should be made mandatory by incorporating them into any final 
regulation that results from this rulemaking.
    While no known outbreaks of botulism attributed to smoked fish have 
been reported since 1963, FDA believes that the failure by 
manufacturers to obtain information about the composition of hot- and 
cold-process products represents a potential health hazard. Without 
analytical results from the testing for water-phase salt and sodium 
nitrite levels, a manufacturer cannot determine whether the fish have 
been adequately processed to inhibit C. botulinum spore outgrowth and 
toxin production. The agency's concerns are underscored by the 
diversity of processing temperatures and salt levels used in the 
manufacture of these products, particularly the lower range 
temperatures and water-phase salt levels (Ref. 24).
    Finally, as stated above, the use of modified atmosphere and vacuum 
packaging with smoked and smoke-flavored fish products is also a source 
of concern. These types of packaging provide an anaerobic environment 
in which C. botulinum spores can grow out and produce botulin, the 
causative agent in botulism. When consumed, the toxin attacks the 
central nervous system and may cause death if untreated within 3 to 6 
days.
    For all these reasons, FDA has tentatively concluded that some type 
of guidance that defines the procedures for the safe processing of 
smoked and smoke-flavored fish is necessary.
    Historically, fish have been smoked in order to preserve them. 
Today, the primary reason for smoking is to impart certain taste and 
texture qualities to the fish. There are essentially two types of 
smoked fish: (1) Those that are subjected to a ``cold process'' that 
leaves the fish soft and moist, with a delicate smoke flavor, such as 
lox, and (2) those that are subjected to a ``hot process'' that 
produces a less moist, firmer product with heavier smoke flavor, such 
as smoked whitefish.
    The processing of these fish basically involves: (1) Cleaning and 
gutting followed by (2) immersion in a brine solution or dry salt in 
order to salt them, (3) drying in a cool temperature to avoid bacterial 
growth, (4) smoking in a smoking chamber at a temperature and for a 
time necessary to achieve the desired ``cold process'' or ``hot 
process'' effect, and (5) packaging and cooling. The taste and texture 
qualities attributable to ``cold process'' smoked fish require much 
lower temperatures during the smoking phase of the process than those 
attributable to ``hot process.'' Salted fish may not be smoked at all.
    As with virtually all fish, the species used to make smoked fish 
are exposed during their lives to C. botulinum, a spore- forming 
bacterium that is ubiquitous in the marine and freshwater environment. 
Type E is the predominant type of C. botulinum found in fish, other 
aquatic animals, water, and sediment, although other types such as A, 
proteolytic and nonproteolytic B, C, D, and F also have been found in 
fish (Refs. 148 through 152). The concentration of C. botulinum spores 
that may be expected in and on a naturally contaminated fish is 
unknown, although it is reported to vary from one spore per 16 g of 
fish to one spore per 200 g (Refs. 153 and 180).
    Under certain conditions, C. botulinum can produce a toxin that 
causes botulism, a disease that attacks the central nervous system of 
humans and can cause death within 3 to 6 days of ingestion if not 
properly treated (Ref. 193). C. botulinum's ability to form spores 
means that in a dormant state, it can survive environments that are 
otherwise hostile to it. C. botulinum is ``anaerobic,'' meaning that 
air constitutes a hostile environment. When conditions become 
favorable, that is, when no air is present, the spores experience 
``outgrowth'' during which toxin can be produced. In fish, C. botulinum 
spores are found in the intestines and can also adhere to the surface 
of fish.
    For these reasons, C. botulinum can be found in the environment of 
most any fish processor and cannot be totally eliminated using 
reasonable means. Moreover, even though a fish might be cleaned, 
gutted, and air packaged, some risk will still exist because C. 
botulinum spores can find their way into muscle tissue during 
processing. Muscle tissue below the surface of the fish can provide an 
anaerobic environment where outgrowth and toxin production can occur if 
time and temperature permit.
    Although the processing procedures in Appendix 1 are based on 
studies of the time-temperature and salinity conditions required to 
prevent the outgrowth of botulinum spores, these practices are also 
effective in the elimination of risk from other pathogenic bacteria 
such as L. monocytogenes. L. monocytogenes is a pathogenic bacterium 
that is widespread in the environment and that is commonly isolated 
from surface waters and other environmental samples. Thus the 
likelihood of finding this pathogen on the exterior surfaces and 
viscera of fish is high. Since 1983, several large outbreaks of human 
listeriosis have been linked to the consumption of contaminated foods 
(Refs. 130, 131, and 132), thereby demonstrating the etiologic 
importance of foodborne transmission of this disease in humans.
    Although listeriosis is a relatively rare illness (approximately 
2,000 reported cases per year in the United States), the exceptionally 
high mortality rate, as high as 34 percent, makes this illness one of 
the leading fatal foodborne diseases in the United States. The highest 
incidence of listeriosis generally occurs in neonates, the elderly, 
pregnant women, and individuals suffering from compromised immune 
systems. However, there are instances in which apparently healthy 
individuals have contracted listeriosis (Refs. 130 and 133).
    The incidence of Listeria species (including L. monocytogenes) in 
frozen raw and cooked seafood products is reportedly as high as 61 
percent (Ref. 136). Indeed, numerous seafood products have been shown 
to support growth of L. monocytogenes (Refs. 137 and 138). L. 
monocytogenes is capable of prolific growth on smoked salmon stored at 
4  deg.C, even when test inocula as low as 6 organisms per gram (g) are 
applied to the surface of fish samples (Ref. 139). Seafoods other than 
smoked or smoke-flavored fish have been epidemiologically linked to two 
outbreaks and one sporadic case of listeriosis (Ref. 140). Furthermore, 
several cooked seafood products have been recalled from the market in 
North America because of contamination with L. monocytogenes, but these 
crises did not involve smoked or smoke- flavored fish products.
    A recent survey of smoked fish and smoked fish products in Iceland 
has shown that 29 percent of samples tested were contaminated with 
Listeria species, including L. monocytogenes (Ref. 141). Another survey 
revealed that 8.9 percent and 13.6 percent of hot- and cold-smoked 
fish, respectively, were contaminated with L. monocytogenes (Ref. 142). 
Cold-smoked fish may pose a significant health risk, particularly when 
stored for extended periods. When raw salmon was inoculated with known 
populations of L. monocytogenes and smoked at 78.8 to 86  deg.F (26 to 
30  deg.C) for 6 hours, and the finished product stored at 39.2 and 50 
deg.F (4 and 10  deg.C) for up to 30 days, investigators observed 
substantial increases in L. monocytogenes populations at both 
incubation temperatures (Ref. 143). No known cases of listeriosis have 
been linked to smoked seafood consumption in the United States.
    In contrast, studies have shown that properly controlled hot-
smoking processes effectively eliminate L. monocytogenes contamination 
(Ref. 144). In raw trout inoculated with high doses of L. 
monocytogenes, stored for 12 hours in a marinade containing 10 percent 
NaCl, and then subjected to a hot-smoke process (dried for 30 minutes 
at 140  deg.F (60  deg.C), cooked at 230  deg.F (110  deg.C) until an 
internal temperature of 149  deg.F (65  deg.C) was maintained for 20 
minutes, and finally smoked for 45 minutes at 140  deg.F), L. 
monocytogenes did not survive the smoking process. However, when fish 
were inoculated after smoking and stored at 46.4 to 50  deg.F (8 to 10 
deg.C), a significant increase in L. monocytogenes populations was 
observed after up to 20 days of storage. These findings further 
emphasize the importance of preventing the contamination of processed 
fish.
    Studies have also shown the importance of controlling the salt 
concentration in smoked fish. Although L. monocytogenes can survive in 
environments containing up to 20 percent NaCl (Ref. 145), it has been 
demonstrated that the organism becomes increasingly more sensitive to 
NaCl when it is exposed to heat processing (Ref. 146).
    Because of the prevalence of L. monocytogenes in the environment, 
it may be impossible to completely eliminate the organism from all 
foods. However, use of the sanitary practices and processing practices 
proposed in this document should prevent cross-contamination and growth 
of the organism in smoked and smoke-flavored seafoods.
    Smoking fish is a delicate process, involving a number of 
interrelated variables including times, temperatures, and exposure to 
smoke, salt, and sodium nitrite, when used. However, FDA believes that, 
by its very nature, this process involves certain inherent risks, risks 
that, if not attended to, can have very significant consequences.
    For example, the times/temperatures involved in the ``hot process'' 
can injure but not kill C. botulinum spores while killing spoilage 
microorganisms. Thus, during the period when the spoilage 
microorganisms are becoming reestablished, surviving C. botulinum 
spores would be presented with an optimum growth environment because of 
the lack of competition. Yet, because of the absence of spoilage 
microorganisms, spoilage odors that would warn consumers away from 
potentially dangerous products would not be present. Botulism toxin 
alone is not detectable by sensory examination.
    In addition, because of the number and types of steps involved, the 
processing of smoked fish involves an unusual amount of handling of the 
product relative to other seafood processing procedures. Increased 
handling presents increased opportunities for contamination during the 
process than would otherwise be the case.
    The finished product also is inherently more risky than most other 
seafood products because it is a ready-to-eat product that is generally 
not cooked before eating. However, the present evidence indicates that 
smoked fish has caused no more cases of botulism in the United States 
than any other type of seafood product. In contrast, fresh fillets that 
are not smoked are intended to be cooked before consumption. Cooking is 
lethal to bacteria and will deactivate botulism toxin. Thus, smoked 
fish products usually do not get the benefit of an additional 
processing step that protects against most bacteriological risks.
    In addition to these inherent characteristics, FDA believes that 
smoked fish present special risks because both domestic and foreign 
processors are now using vacuum packaging to a substantial extent--much 
more so than are other segments of the seafood industry. A 1988-1989 
FDA and New York State survey of domestic processing plants, for 
example, showed that 45 percent of the firms visited vacuum-packaged 
smoked fish. However, there is no evidence to show a linkage between 
vacuum packaging of smoked fish and illness in the 5 years since this 
survey was completed.
    An economic incentive for use of vacuum packaging is the extended 
shelf-life of the product, made possible by the anaerobic environment 
in the package that prevents the growth of some spoilage microorganisms 
and slows the growth of others. Because this anaerobic environment 
cannot prevent spoilage altogether, vacuum-packaged products must still 
be refrigerated.
    Unfortunately, the anaerobic environment greatly favors the 
outgrowth of any C. botulinum spores that may be present over the 
development of telltale spoilage microorganisms. Thus, C. botulinum 
outgrowth can occur before spoilage if a vacuum-packaged product is 
temperature abused, i.e., not refrigerated. Moreover, as discussed 
elsewhere in this document, the growth of L. monocytogenes and C. 
botulinum type E and nonproteolytic type B is possible even at 
refrigeration temperatures below 40  deg.F (4.4  deg.C). FDA believes 
that strict controls are needed to overcome this risk.
    In 1970, FDA issued a final rule for smoked fish in response to 
outbreaks of botulism attributed to vacuum-packaged smoked fish 
products (35 FR 17401, November 13, 1970). Among other things, the rule 
attempted to control the risk of botulism by setting conservative 
processing parameters for time, temperature, and salinity that would 
minimize the opportunity for C. botulinum spore outgrowth. These 
parameters were based on the relatively limited research that had been 
conducted up to that time with one species of fish. Many processors 
claimed that these parameters would have resulted in a product that was 
too salty and too dry in texture to be marketable.
    The rule was overturned in court due to procedural problems (United 
States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 
1977)). However, in rethinking this rule after the remand, FDA decided 
that research was needed into the relationships among time, 
temperature, and salinity to develop processing parameters that would 
provide safety without producing an undesirable product that consumers 
would not buy.
    This research has been successfully conducted by FDA, the National 
Marine Fisheries Service, and the industry. FDA has prepared the time, 
temperature, and salinity parameters in the Hazard Assessment Guide 
based on the results of this research.
1. Need for Guidance
    FDA routinely inspects smoked fish processing establishments for 
sanitary conditions using the guidance in 21 CFR part 110, ``Current 
Good Manufacturing Practice in Manufacturing, Packing, or Holding Human 
Food'' (Ref. 196) and in the FDA Inspection Operations Manual, Chapter 
5, Establishment Inspection and section 616.6 Smoked Fish inspection 
methods (Ref. 197). In addition to the Establishment Inspection Reports 
(EIR's) discussed in section G, EIR's for smoked fish processing 
establishments over the past few years (1985 to the present) show 
evidence that the use of manufacturing procedures are not in line with 
CGMP's. The EIR's also show that processing parameters and controlled 
processing and storage techniques, commonly recognized as appropriate 
in the industry (Ref. 182) are not being used (Ref. 169).
    Typical observations by FDA officials in these inspections include: 
(1) Live flies in production areas providing a vehicle for 
contamination and recontamination of products; (2) standing water in 
production rooms providing a medium for microbial growth and 
contamination from splashed water; (3) utensils not sanitized prior to 
use; (4) open bags of raw materials in storage areas exposing products 
to flying insects and potential microbial contamination; (5) smoke 
racks encrusted with pieces of fish from previous processes, thus 
providing an opportunity for microbial growth; (6) refrigerators being 
used for both raw and finished products, thus providing an environment 
for microbial growth through cross-contamination between unprocessed 
and processed products; (7) overcrowded fish in brine tanks, whereby 
some fish are not fully submerged in brine, resulting in lower and 
uneven levels of salt uptake that would not be effective in inhibiting 
spore outgrowth; (8) salinity and microbiologic testing not performed 
on products; (9) low minimum water-phase salt levels (0.88 to 1.79 
percent) that would not inhibit C. botulinum spore outgrowth and toxin 
production; and (10) poor employee practices that foster microbial 
contamination, including spitting into sinks adjacent to sinks used to 
thaw product, not washing or sanitizing hands, and street clothes in 
contact with product (Ref. 169). (See also Ref. 200.)
    As part of its Fiscal Year (FY) 91 Domestic Fish and Fishery 
Products Inspection Assignment, FDA conducted food safety inspections 
of smoked fish establishments. These inspections revealed a continuing 
pattern of problems in these facilities. In over half of these 
inspections FDA found violations that required action, ranging from 
minor violations, which are normally handled by informing the firm's 
official during the inspection, to more serious violations that 
prompted some form of official agency action (Ref. 200).
    In addition, several States, working through AFDO, have expressed 
concern that a potential health hazard exists with smoked and smoke-
flavored fish products and have stated that a Federal regulation is 
necessary for uniform regulation of the production and distribution of 
these foods (Refs. 170 and 189). AFDO is an organization of Federal, 
State, and local regulatory officials with membership representing all 
50 states, as well as FDA and other Federal agencies. AFDO's Central 
States Regional organization held a meeting in 1988, attended by public 
health officials from 6 states in which the smoked fish industry is 
concentrated, Canada, and NMFS, to discuss a Federal regulation 
governing the processing, storage, and distribution of smoked and 
smoke-flavored fish products. In December, 1989, AFDO first passed a 
resolution requesting that FDA expedite the rulemaking process to 
establish uniform Federal regulations to ensure that safe smoked fish 
processing methods are utilized for fish products sold in the United 
States. In December, 1990, AFDO passed resolution 8, which strongly 
encouraged FDA to ``accelerate the promulgation of smoked fish CGMP's 
so that concerned States can move forward with their efforts to ensure 
the safety of smoked fish'' (Ref. 170). FDA recognizes the need to 
address the hazards associated with smoked and smoke-flavored fishery 
products and therefore is setting forth the procedures in Appendix 1 in 
the interest of protecting the public health.
    The need for some type of agency guidance on smoked fish is also 
evidenced by several other factors. First, the 1970 final rule, which 
covered only hot-process smoked and smoke-flavored fish and the 
processing parameters that they required, is still being used as a 
guideline by some States. These earlier parameters could result in 
commercially undesirable products. These parameters ought to be updated 
with the current technological understanding and processing flexibility 
for both hot and cold smoked products. The guidance in this document 
can provide the basis on which such updating can occur.
    Second, the manufacture or sale of cold-processed fish products is 
not permitted in at least two States because there are no regulations 
or regulatory guidelines for these products (Ref. 170). There is some 
pressure, however, to permit the sale of these products. The Canadian 
Government, for example, has urged these States, Minnesota and 
Michigan, to permit the sale of these products so that Canadian 
products may be exported to the United States (Ref. 170). Some type of 
guidance that helps to define the processing parameters and techniques 
that reduce human health risks from cold-process smoked and smoke-
flavored fish products would provide State, as well as federal, public 
health officials with the tools necessary to evaluate the safety of 
cold processed products manufactured in the United States, as well as 
those imported into the United States.
    Third, in 1988 FDA conducted a survey of processing parameters used 
by fish smoking plants in the United States. Seventy five percent of 
the firms surveyed did not do final product testing to ascertain 
whether their products met commonly recognized (Ref. 182) parameters 
for their products (Ref. 24). The information collected in this survey 
augmented information obtained from the New York State Department of 
Agriculture and Marketing (Ref. 24), which had conducted a similar 
survey of fish smoking establishments in that State at approximately 
the same time. A total of 64 establishments were surveyed by FDA and 
New York State, representing over 90 percent of the smoked fish 
manufacturers in the United States. Among the species of fish included 
in the survey were chubs, bluefish, trout, carp, salmon, whitefish, and 
herring. Processing information was collected from manufacturers, and 
samples were collected for laboratory analysis.
    The following chart summarizes the results of these surveys and 
compares them to proposed processing parameters: 

                                                             1988-1989 Domestic Survey Data                                                             
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Characteristic                       FDA                          New York                                      Proposal                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cold-Smoked Products:                                                                                                                                   
    Temperature range.......  38 to 180  deg.F..............  34 to 90  deg.F...............  50  deg.F for 24 hours or 90  deg.F for 20 hours.         
    Water-phase salt........  1.33 to 18.1 percent..........  1.4 to 7.4 percent............  2.5 to 3.5 percent.\1\                                    
    Nitrite range...........  3.75 to 994 ppm...............  ..............................  100 to 200 ppm.                                           
    Percentage of firms that  40 percent....................  50 percent....................  ..........................................................
     do not know water-phase                                                                                                                            
     salt level.                                                                                                                                        
Hot-Smoked Products:                                                                                                                                    
    Temperature range.......  90 to 210  deg.F..............  128 to 240  deg.F.............  145  deg.F.                                               
    Water-phase salt........  0.88 to 27.5 percent..........  1.3 to 7.0 percent............  3.0 percent.\1\                                           
    Nitrite range...........  15 to 239 ppm.................  ..............................  ..........................................................
    Percentage of firms that  39 percent....................  72 percent....................  ..........................................................
     do not know water-phase                                                                                                                            
     salt level.                                                                                                                                        
    Total number of firms     76 percent....................  74 percent....................  ..........................................................
     that do not test their                                                                                                                             
     products (for 1 or more                                                                                                                            
     processing parameter).                                                                                                                             
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Actual level depends on other processing factors.                                                                                                    

    Oven temperatures for hot processing ranged from 90 to 240  deg.F 
(32 to 116  deg.C) and from 38 to 125  deg.F (4.4 to 52  deg.C) for 
cold processing. Water-phase salt content in hot-process products 
ranged from 0.88 to 27.5 percent and in cold-process products from 1.33 
to 18.1 percent. Twenty-eight firms (43.7 percent) vacuum packed cold-
process products, but 60.7 percent of those firms did not test final 
products for water-phase salt content or for residual sodium nitrite. 
Twenty-five firms (39.1 percent) vacuum packed hot-process products, 
but 68 percent of those firms did not test final products for water-
phase salt content or for residual sodium nitrite. Seventy-five percent 
of the firms surveyed did not test final products for water-phase salt 
content or for residual sodium nitrite, where used. Since this survey 
was conducted, the frequency of FDA inspections of smoked fish 
establishments has been increased over 50 percent each year.
    Therefore, FDA is providing guidance on the appropriate parameters 
for processing smoked fishery products in Appendix 1 to this document.
    The guidance addresses critical control points that apply to these 
products as a class and that will typically be identified in the HACCP 
plans of most processors of smoke and smoke-flavored products. The 
guidance also addresses ways of controlling hazards at these critical 
control points.
    The key processing parameters that must be controlled to ensure the 
safety of these products involve time, temperature, and salinity. While 
a range of time-temperature-salinity (TTS) values will provide a safe 
product, there are now known safety minimums for these values that have 
been developed through years of research. Processors whose TTS values 
fall below these minimums do not produce a safe product and shift much 
of the burden of preventing botulism toxin outgrowth to those who take 
possession of these products after they leave the processing plant, 
including the ultimate consumer. This burden includes, among other 
things, maintaining strict temperature control at 40  deg.F or lower 
even though it is known that many commercial and home refrigerators are 
unable to maintain this temperature (Ref. 201).
    These TTS minimums are known to produce a marketable product, 
because there are processors that operate in conformance with them. 
Moreover, because they are minimums, these values allow for the 
production of a variety of products, such as different types of lox 
with varying amounts of saltiness, to suit different tastes.
    These minimum TTS values provide the only scientifically valid way 
developed to date of ensuring that no botulism toxin will be produced 
over the shelf life of the product under proper refrigeration 
conditions or under conditions of moderate temperature abuse. The 
minimum values, coupled with the sanitation practices proposed in this 
document, should also ensure against the presence of detectable L. 
monocytogenes.
    These minimum TTS values are being issued at this time as proposed 
guidance to ensure maximum flexibility. If these values are reflected 
in the HACCP plans that are required by proposed subpart A of 21 CFR 
part 123, and are being effectively implemented by the processor, the 
agency is likely to find that the plan and its implementation are 
adequate with regard to those critical limits and critical control 
points. The same holds true for the other types of controls recommended 
in the guidance.
    The agency is requesting comment on this approach, and on the 
following alternatives:
    (1) Issue all or part of the materials relating to smoked and 
smoke-flavored fishery products in Appendix 1 as regulations, rather 
than guidance. Given the public health concerns associated with these 
products and the scientific basis for the TTS minimums, it may well be 
appropriate to issue them as regulations. Such regulations would take 
into account advances in knowledge and technology by allowing 
processors to use alternative processing parameters so long as these 
alternatives were scientifically demonstrated to produce an equivalent 
level of safety. (Section 11 of the guidance relating to smoked and 
smoke-flavored fishery products in Appendix 1 contains such a feature.)
    (2) Issue a performance standard as a regulation, while leaving the 
materials in Appendix 1 as guidelines on how processors could meet the 
performance standard. The likely performance standard would be, as 
suggested above (and included in section 11 of the guidance relating to 
smoked and smoke- flavored fishery products in Appendix 1): (a) for 
botulism, zero toxin production in the product during a time period 
through--and slightly beyond--the shelf life of the product, 
demonstrated through inoculated pack studies under normal and moderate 
abuse conditions; and (b) no detectable L. monocytogenes in the final 
product.
    (3) Maintain the guidance relating to smoked and smoke-flavored 
fishery products in the FDA Fish and Fishery Products Hazards and 
Controls Guide and control safety through the HACCP requirements for 
all seafood in proposed subpart A.
    FDA requests comment on which of these alternatives is most likely 
to ensure that smoked fish will be safe and is most consistent with the 
agency's obligations under the act. In the absence of a regulation or 
guideline, how can the agency best ensure that the results of the 
research that it has conducted will be available for use by the 
industry? FDA solicits comments on these and the matters raised above.

N. Verification Issues

    As described in section IV.A. of this document, one of the NACMCF's 
seven HACCP principles involves verification that the HACCP system is 
working. NACMCF recommends that HACCP plans include procedures for 
verification of the HACCP system (Ref. 34, p. 200). FDA advises 
processors to consider adopting this recommendation, but has not 
proposed to require it because the agency expects verification to occur 
through: (1) A firm's consistency with the controls and limits to be 
provided by FDA in the HACCP guidance described in section VII.C. and 
M. of this document; (2) third-party technical assistance provided 
through trade associations, universities and government agencies; and 
(3) review of all HACCP monitoring records by trained individuals 
before distribution of product (see proposed Sec. 123.8(b)); the 
proposed corrective action requirements (see proposed Sec. 123.7), 
especially the provision for assessment of HACCP plans as a consequence 
of deviations (Sec. 123.7(a)(4)); the recommended use of process 
authorities for cooked, ready-to-eat products (see Appendix A); the 
proposed general training requirements (see proposed Sec. 123.9); and 
inspector review during routine agency inspections. FDA invites comment 
on whether this approach is adequate to ensure that the NACMCF 
verification principle is being properly addressed, both for individual 
firms and for the overall HACCP program.
    For individual firms, NACMCF specifically discourages the sole 
reliance on end-product sampling for verification purposes (Ref. 34, p. 
201). FDA also has questions concerning the efficacy of end-product 
sampling as the only way to measure the success of HACCP. These caveats 
notwithstanding, FDA invites comment on what tests should be used to 
measure success, both in terms of individual firms and the program as a 
whole, and how frequently such tests should be administered.

VIII. Other Approaches to HACCP

    This preamble has described in great detail the HACCP system that 
is being proposed and the reasoning behind each proposed provision. 
While the agency is inviting comment on the merits of each provision, 
FDA also invites comment on the overall system, including whether some 
other approach to HACCP or some variation of the proposed approach 
might be preferable. Variations on the proposed approach include, but 
are not limited to: (1) Requiring HACCP only for higher risk seafood 
products; (2) exempting small firms from HACCP requirements; (3) 
staggering the effective date for implementation based on size of firm 
or risk; and (4) deleting or altering some of the requirements in this 
proposal in order to facilitate implementation and lower costs. A brief 
discussion of each of these variations follows:

A. Higher Risk Only

    An alternative to requiring HACCP for all commercial seafood 
products would be to require it for products or processes that have 
been linked to significant numbers reported seafood-borne illnesses. As 
section II.B. of this document explains in detail, many of the reported 
illnesses from seafood involve raw molluscan shellfish and certain 
species of finfish that can accumulate scombrotoxin and ciguatoxin. 
Other seafood products cause illness but are not as commonly reported. 
FDA invites comment on whether this proposed regulation should apply 
only to molluscan shellfish and the species responsible for 
scombrotoxin and ciguatoxin poisonings.
    A variation on this approach would be to have the proposed 
regulation apply to those species and processes with a higher potential 
for harm, even if actual illnesses from them cannot be documented from 
the foodborne illness reporting system. As described earlier in the 
preamble, the fact that the system is not recording illnesses from a 
particular food does not mean that illnesses are not occurring. Also, 
potential for harm need not always be measured in terms of the number 
of illnesses that are actually occurring. For example, some problems, 
like botulism, may occur infrequently, but when they do, the 
consequences can be devastating. Based on the potential for harm, other 
candidates for inclusion would be: (1) Hot-process smoked and hot-
process smoke-flavored fish, cold-process smoked and cold-process 
smoke- flavored fish, because of the hazards of botulism and listeria; 
(2) cooked, ready-to-eat products, because of the microbiological 
hazards associated with products that are not intended to be cooked by 
the consumer; (3) low acid canned foods, because of the hazard of 
botulism and general complexity of the processing operation; (4) raw, 
ready-to-eat products, because of the risk of parasites; and (5) 
species that require a judgment as to appropriate location of harvest 
to avoid unsafe pesticide or industrial contaminant levels.
    FDA also invites comment on the effect of using a modified approach 
on the regulation of imports, especially with regard to the types of 
products described in item (5) above.

B. Exempting Small Firms

    FDA invites comment on whether small firms should be exempt from 
the proposed regulation. Even if exempted, these firms would still be 
subject to the requirements of current food safety law and to 
inspection by FDA and State authorities.
    As stated earlier in this preamble, small operations are the norm 
in the seafood industry. A significant majority of processors have 
total revenues of under 1 million dollars. If small firms are to be 
exempted, FDA invites comment on the criteria that should be used for 
exempting them, including how a small firm should be defined for 
purposes of an exemption.
    The implementation of HACCP may be more burdensome for small firms 
than for large firms. Large firms tend to have quality control 
personnel already in place. In addition, many regulatory requirements 
are less burdensome for a large firm in proportion to output than they 
are for a small firm. On the other hand, FDA is taking steps, such as 
the preparation of its HACCP guidance, to minimize the cost of these 
regulations for small businesses. Thus, such an exemption may not be 
needed.
    The agency also points out that, because many large firms already 
have quality control systems, an exemption for small business would 
appear to result in requiring HACCP for that segment of the industry 
(i.e., large firms) that needs it the least. Large processors, 
moreover, tend to process relatively low risk products, such as breaded 
fish and shrimp and raw fish blocks. Many high-risk processors, such as 
processors of cooked, ready-to-eat products, tend to be small, and 
processors of raw molluscan shellfish tend to be very small.
    Nonetheless, an exemption for small business could be limited to 
those small businesses that produce low risk products, and FDA invites 
comment on this approach. As stated earlier, however, the criteria for 
determining low as well as high risk are not clear, due largely to the 
limitations of the U.S. foodborne illness reporting system. Moreover, a 
case can be made that risk also relates to the margin for error in a 
processing operation and to the consequences of failure as well as to 
the actual occurrence of illness.
    With these points in mind, FDA invites comment on how to define 
``low risk.'' FDA also invites comment on what the nature of the 
exemption should be. Should a firm be exempt from all or part of the 
HACCP requirements? As circumstances change, a HACCP-based analysis of 
risk by a firm might reveal that the firm has become a high risk 
processor rather than a low risk processor. In addition, FDA invites 
comment on whether such an exemption should be obtained by petitioning 
the agency.
    Finally, even if an exemption were to be adopted in the final rule 
based on the comments received, the agency would still encourage 
voluntary adoption of HACCP systems by exempted firms. The advantages 
that HACCP is expected to provide in terms of consumer confidence, 
control of process, and access to international markets warrant 
adoption of this system.
    FDA also invites comment on the effect of a small business 
exemption on the regulation of imports. How would HACCP be applied to 
imports under a tiered approach? Would it be possible to treat domestic 
and imported products equally under such an approach?

C. Staggered Phase-in

    The proposed regulations include an effective date of 1 year from 
the publication of a final rule. FDA has explained the reasoning behind 
this proposed effective date and has invited comment on it elsewhere in 
this preamble. In addition, comments are invited on the merits of a 
staggered phase-in instead of a single implementation date for all 
affected entities.
    The two most obvious ways of accomplishing a staggered phase-in 
would be to differentiate on the basis of size or on the basis of risk. 
Differentiating on the basis of size would presumably allow small 
businesses to have a longer time or times for implementation than would 
be allowed for larger firms. As suggested earlier, large firms are 
probably much more able to implement a HACCP system than are small 
firms. Theoretically, the longer lead time for small firms would allow 
the private sector to develop an infrastructure that could help small 
firms implement HACCP. Such an infrastructure could include process 
authorities (see the preamble discussion on cooked, ready-to-eat 
products), testing facilities, and consulting services from trade 
associations, academia, and others.
    As an additional consideration, FDA will likely learn lessons from 
its experiences in implementing the regulation that it could apply to 
the benefit of those that would have to implement it at a later date. 
For example, FDA is considering whether it should make the first review 
of HACCP plans by agency investigators a nonregulatory evaluation to 
facilitate plan development by the processor (although the overall 
inspection of the plant would be regulatory). The agency invites 
comment on this approach. Presumably, the more experience the agency 
has, the better this evaluation will be.
    On the other hand, as noted above, small firms are involved in the 
processing of higher risk products. How does this fact bear on the 
possibility of longer implementation times for small firms?
    Differentiation solely on the basis of risk appears to be more 
complex than differentiation on the basis of size. If high risk 
products were to be phased in first, it would appear that those with 
the most complex plans to develop and implement would receive the 
shortest lead time, while those with the simplest plans would receive 
the longest lead time.
    Also, the criteria for determining risk would have to be carefully 
considered. FDA asks for comment on whether a staggered start should 
begin with raw molluscan shellfish and certain species of finfish that 
can accumulate scombrotoxin and ciguatoxin, or whether other criteria 
should apply, as discussed previously.
    FDA invites comment on all these matters. FDA also invites comment 
on the effect of a phase-in approach on the regulation of imports. How 
could this approach be applied to imported products?

D. Deleting or Modifying Aspects of This Proposal, or Taking Some Other 
Step, to Reduce the Burden of Implementation

    As has already been explained in this preamble, FDA has proposed 
only the basics of HACCP in order to keep the regulatory burden to a 
minimum. Several features of HACCP included within the NACMCF's seven 
principles, such as flow charts and the establishment of ``HACCP 
teams,'' are noted in this preamble, but FDA has not proposed to 
require them. Nonetheless, FDA acknowledges that, theoretically, there 
are a number of ways in which this proposal could be scaled back even 
further. FDA invites comments on whether such scaling back would be 
desirable, and, if so, how it could be done. Possible areas for scale-
back include, but are not limited to:
    (1) Requiring only negative, rather than positive records. Negative 
records note only deviations from critical limits and how they are 
corrected. If a critical control point is under control, no record is 
made. Admittedly, FDA has reservations about such an approach. For 
example, it is virtually impossible for firms or for FDA to spot trends 
that could lead to problems if only negative records are being kept. 
Nonetheless, FDA invites comment on this approach.
    (2) Developing generic plans by FDA that list critical control 
points and contain other information for various industry segments.
    (3) Deleting some or all of the proposed specific sanitation 
requirements.
    (4) Requiring HACCP only for the domestic industry. The HACCP 
requirements would become the basis for negotiating agreements with 
other countries relating to the equivalency of regulatory programs.
    (5) Deleting or modifying the proposed training requirements.
    (6) Requiring HACCP for processing hazards only. The Canadian HACCP 
system does not involve species-related safety hazards.
    (7) Exempting warehouses.
    (8) Although only in guidelines (Appendix B, Scombroid Toxin-
Forming Species), sanctioning the receipt by a processor from a 
harvester of an assurance of good handling practices, rather than 
detailed time/temperature records. Such an assurance, without further 
verification, would be acceptable only from harvesters with histories 
of delivering acceptable products.
    These four alternative approaches to implementing these regulations 
are not necessarily mutually exclusive. Comments are invited on them in 
combination as well as on them individually.

E. Information and Consumer Awareness

    In addition to requesting comment on alternative approaches to 
HACCP, FDA is taking the opportunity to invite comment on the general 
subject of complementary risk reduction activities, primarily directed 
toward postprocessing handling. Elsewhere in this document, FDA invited 
comment on the advisability of applying HACCP or alternative regulatory 
approaches to commercial entities that are not directly subject to 
these proposed regulations, i.e., harvesting vessels, common carriers, 
and retail establishments (although not necessarily doing so as part of 
this rulemaking). In addition, FDA seeks comment on appropriate 
education and information that should be directed toward consumers and 
recreational fishermen. The commercial application of HACCP principles 
can mitigate somewhat the effects of poor consumer handling practices 
by helping to ensure that a safe product reaches the home, but no such 
program can prevent illnesses caused by improper home handling. 
Similarly, HACCP practiced by processors can have no effect on 
recreational fishermen who consume their own catch.
    Education has always been an important part of FDA's comprehensive 
seafood safety program, but the agency believes that more can be done. 
Recent FDA education projects include the initiation of a seafood 
hotline, which has been consulted by over 26,000 individuals on a wide 
range of seafood safety issues since it began in October 1992. (The 
hotline can be reached by calling toll-free, 1-800-FDA-4010.) FDA also 
recently developed brochures aimed at advising certain medically 
compromised populations that they should not eat molluscan shellfish 
without adequate cooking. FDA invites comment on other types of 
education and information activities that might be useful, including 
more information that might be made available through grocery stores, 
pharmacies, and other establishments, through the media, and through 
other means, including labeling. FDA is considering the merits of 
labeling information for consumers of molluscan shellfish, and will 
address this issue in proceedings separate from these regulations. FDA 
notes that several states have already mandated, or are in the process 
of mandating, point- of-purchase information for raw molluscan 
shellfish.
    The agency also invites comment on whether FDA should consider 
proposing to require handling instructions for consumers on the 
labeling of seafood. The Department of Agriculture has proposed such 
requirements for meat and poultry (58 FR 58922, November 4, 1993).
    FDA has a longstanding program to control the levels of 
microorganisms of public health concern in seafood. This program 
includes compliance policies on such levels, including zero levels 
(i.e., none detectable based upon official methods) for such pathogens 
as Listeria monocytogenes in cooked, ready-to-eat products and 
Salmonella in all foods. These proposed regulations require control of 
microbial pathogens through HACCP principles, including specific 
sanitation controls. Even so, FDA recognizes that no system can reduce 
all risks to zero. Because all foods in the home, including seafood, 
are subject to mishandling and cross contamination from other sources, 
FDA invites comment on the general subject of handling instructions. 
Should FDA decide to propose handling instructions, it would do so as a 
regulatory proposal separate from the proposed HACCP requirements for 
seafood.

IX. Paperwork Reduction Act

    This proposed rule contains requirements for information 
collections which are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1980. The title, 
description, and respondent description of the information collection 
are shown below with an estimate of the annual reporting and 
recordkeeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Procedures for the Safe Processing and Importing of Fish and 
Fishery Products.
    Description: The information requirements in this proposed rule are 
essentially monitoring and recordkeeping requirements encompassing 
critical control points in the production and inspection of fish and 
fishery products as established in the HACCP plans of processors and 
importers. The specific information collected and the frequency of 
collection will depend on such factors as the species and the 
processing conditions. It will include observations of processing 
parameters such as the time and temperature of processing and storage; 
the condition of raw materials; the results of chemical and 
microbiological tests; the sanitation conditions in a processing 
facility; the corrective actions taken in response to processing 
deviations, etc. Records identifying production lot codes and date of 
manufacture will also be maintained. Records will be maintained by the 
processing facility or at an importer's place of business for 1 year 
after the date of preparation in the case of refrigerated products and 
at least 2 years for frozen products.
    This information will be used by FDA investigators during regularly 
scheduled inspections of processing plants, or at the time of entry of 
imports, to determine whether products were processed under sanitary 
conditions and processed, packaged, stored, and distributed using HACCP 
control techniques to avoid hazards that might cause the products to be 
adulterated. The information will also be used when necessary to trace 
and remove potentially hazardous products from the marketplace.
    Records of processing conditions will also provide a means for 
processors to monitor the quality of their products and to alert them 
when a deviation from the critical limits established in the HACCP plan 
has occurred that may create a potential public health hazard in the 
final product.
    The figures provided below reflect an FDA estimate of the annual 
hours of monitoring and recordkeeping based upon currently available 
data and assumptions about the effects of the requirements in proposed 
part 123. The estimate is based on data used to develop cost estimates 
for the economic impact analysis required by Executive Order 12866 and 
thus is subject to the same types of uncertainties described elsewhere 
in this preamble. For example, the agency has anecdotal evidence that 
the burden on firms that are operating under a mandatory HACCP system 
established by the State of Alaska is more nominal. Consequently, FDA 
acknowledges the possibility that the estimates provided here are 
conservatively high, indicating recordkeeping burdens that are higher 
than would customarily be the case. FDA specifically invites comments 
on this point.
    Description of Respondents: Businesses. 

          Estimated Annual Reporting and Recordkeeping Burden           
------------------------------------------------------------------------
                        Average annual burden                           
 Number of respondents      per respondent          Total burden all    
                               (hours)            respondents (hours)   
------------------------------------------------------------------------
4,349.................              650                  2,826,850      
------------------------------------------------------------------------

    The agency has submitted a copy of this proposed rule to OMB for 
its review of this information collection. Interested persons are 
requested to send comments regarding this burden estimate or any other 
aspect of this collection of information, including suggestions for 
reducing this burden to FDA's Dockets Management Branch (address 
above), and to the Office of Information and Regulatory Affairs, OMB 
rm. 3208, New Executive Office Bldg., Washington, DC 20503, Attn: Desk 
Officer for FDA.

X. Economic Impact

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 compels agencies to use cost-benefit analysis as 
a component of decisionmaking. The Regulatory Flexibility Act requires 
regulatory relief for small businesses where feasible. FDA finds that 
this proposed rule constitutes a major rule under both Executive Order 
12866 and the Regulatory Flexibility Act. A summary of the preliminary 
regulatory impact analysis (PRIA), which may be obtained from Dockets 
Management Branch (address above), is presented below.
    Executive Order 12866 requires Federal agencies to justify the need 
for regulations by demonstrating that the problem that the regulation 
is designed to remedy cannot be adequately addressed by measures other 
than Federal regulation. In its review of such alternatives, FDA finds 
that the current system (periodic inspection plus sampling of a small 
proportion of seafood), coupled with the uncertainty in estimating the 
illnesses related to seafood, has not adequately ensured consumers that 
a minimum level of safety has been established. Although the tort 
system is not able to provide remedies for unsafe seafood, the price 
system provides some differentiation between products based on brands 
and retail reputation. However, the price system works in conjunction 
with current Federal regulation which signals consumers as to a minimum 
level of seafood safety. As is argued in the preamble, countless public 
arguments and attempts at legislation imply that the minimum levels 
that some consumers believe they are getting (those that do not search 
for higher levels) is probably higher than the actual levels of seafood 
safety.
    The tort system fails because consumers are often unable to trace 
either the source of their foodborne illness to seafood, and even where 
that is possible, it is often difficult to trace seafood to a specific 
company.

A. Regulatory Options

    FDA has evaluated multiple options to address the compelling public 
interest in further ensuring seafood safety. These options include: (1) 
Maintaining the existing approach--``snapshot'' inspections and 
sampling; (2) significantly increasing the frequency of both snapshot 
inspections and sampling under the existing approach; (3) beginning a 
voluntary HACCP program in addition to the existing approach; (4) 
beginning mandatory HACCP for high risk products only, in addition to 
the existing approach; (5) beginning mandatory HACCP for all seafood 
(the proposed approach); (6) beginning a more comprehensive mandatory 
HACCP program than that proposed, similar to the Model Seafood 
Surveillance Project (MSSP), which would include all CGMP's, quality 
factors, and economic fraud as critical control points; and (7) 
beginning a mandatory water-to-table HACCP program which would include 
all vessels, carriers, and retail food operators.
    The existing approach does not adequately address the compelling 
public interest in further ensuring seafood safety because sampling the 
large volume of seafood with FDA's limited resources cannot detect many 
violative products. Increasing the frequency of sampling and 
inspections is also unlikely to resolve this problem without 
significant increases in funding. These options are discussed 
extensively in the preamble to the proposed regulations and in the 
PRIA. The third option, voluntary HACCP, has been in existence at NOAA 
and has very few participants. The forth option, risk-based HACCP, has 
been evaluated in the PRIA in several forms, including HACCP only for 
the highest risk products from a historical perspective and HACCP only 
for those products with the potential for catastrophic risk. For 
example, one possibility evaluated under this option would be to 
implement HACCP solely for molluscan shellfish, which NAS and other 
groups have concluded constitute most of the risk from seafood. The 
sixth option is more costly than the proposed option and includes more 
reliance on CGMP's. Finally, the last option involves mandatory HACCP 
for nearly 1 million establishments.
    The options evaluated in the PRIA have both lower and higher costs 
than the proposed option. However, the benefits of all options are not 
equal to the proposed option. FDA has quantified net benefits of some 
of the high risk options and has found them to have been positive net 
benefits for those costs and benefits which have been quantified.
    These options are not all equal in terms of costs and benefits. 
They differ significantly from one another in this regard, as well as 
from the option that FDA has selected to propose as new part 123. They 
are also not equal in their ability to meet all the regulatory 
objectives stated in the preamble, including effective treatment of 
imports and an appropriate alignment of industry and government 
responsibilities. FDA seeks comment on the costs and benefits as well 
as on the general pros and cons of all the stated options and on any 
options that the agency may have overlooked. It is extremely important 
that FDA's evaluation of regulatory options be as thorough as possible 
for purposes of developing a final rule, and that the agency be able to 
fully articulate the distinctions among them and the significance of 
those distinctions.

B. Costs

    There is no single source of data that FDA has found to be entirely 
satisfactory for developing a preliminary estimate of the costs of the 
proposed regulations. Consequently, FDA has considered two sources of 
information, each with its own strengths and weaknesses. The results 
provide a range of possibilities, and FDA invites comment on them.
    The first source is U.S. seafood processors that have actually 
implemented HACCP systems. The number of such firms may exceed 100. 
Understandably, many firms are reluctant to make public detailed 
information about the costs of operation; consequently, the information 
available to FDA from this source is incomplete. On the other hand, 
there is enough information from which some preliminary conclusions can 
be drawn that are relevant to an economic assessment.
    The second source is a study of the costs of implementing a form of 
HACCP that was developed by the Department of Commerce for the 
congressionally mandated MSSP. That study was performed by an 
independent contractor for the National Fisheries Education and 
Research Foundation, Inc., and commissioned under a grant from NMFS. 
While these data are the most detailed available, fitting them to the 
proposed regulations required extensive adjustments and extrapolations. 
Thus, these data also fail to eliminate the considerable uncertainty of 
the results as they relate to these proposed regulations.
1. Costs: Actual Industry Experience
    FDA has some information relevant to the actual costs of 
implementing HACCP experienced by a number of seafood firms. While this 
information is neither detailed nor complete enough to definitively 
answer the question of how much the proposed regulations will cost the 
industry, it does provide insight into the costs of the proposed 
regulations.
    This information includes responses to a 1991 evaluation 
questionnaire from four of the eight firms that participated in the 
FDA/NOAA seafood HACCP pilot in 1990-1991 (Ref. 40). It also includes 
information more recently provided to FDA from seven firms through the 
assistance of NFPA, and from two trade associations. The trade 
associations, the NFI and the New England Fisheries Development 
Association (NEFDA) provided FDA with summary information about member 
firms that were implementing HACCP systems. NEFDA has operated a HACCP 
pilot with member firms through a Federal grant. The two trade 
associations provided information on 16 firms. The seven firms that 
provided information about themselves through NFPA operate a total of 
44 processing plants, so FDA has information on at least 64 plants 
(Ref. 129).
    The firms represent a good cross section of processing operation 
types, including canned, fresh, frozen, smoked/salted, and cooked, 
ready-to-eat products as well as molluscan shellfish. The majority of 
firms were involved in HACCP as participants in either pilot programs, 
the NOAA fee-for-service program, or the State of Alaska program, and 
therefore have been subject to some form of third party verification of 
their HACCP systems. Virtually all of them developed HACCP plans, and 
the majority of these included critical control points for quality or 
economic fraud or both in addition to safety. In this respect, the 
majority of firms implemented a more extensive form of HACCP than is 
being proposed by FDA.
    Presumably, start-up costs for HACCP are normally higher than 
operating costs in subsequent years. The majority of firms that could 
estimate their own start-up costs indicated costs in the $1,000 to 
$5,000 range. The remaining minority appear to be roughly equally 
divided between lower and higher costs. A few firms indicated costs in 
the $20,000 or higher range. These may be firms that decided to hire 
additional personnel in order to install or implement HACCP.
    It should be noted that the cost figures that come from firms that 
operate more than one plant are for the total costs of their plants 
collectively; in order to calculate the average start-up cost per plant 
for these firms, their costs would have to be divided by the number of 
plants.
    Nearly twice as many firms did not hire additional personnel or did 
not anticipate hiring additional personnel as a result of operating 
HACCP systems as those who did or felt the need to do so. The 
overwhelming majority of firms reported that they believed that the 
advantages they derived from HACCP were worth the costs to them in 
terms of better control over their operations, better sanitation, and 
greater efficiencies, such as reduced waste. Virtually all foresaw 
long-term benefits from operating under HACCP.
    FDA notes that there are several uncertainties with this data. The 
first is that FDA does not know the extent of previous HACCP-type 
activities in these firms so that they may have different incremental 
costs than the industry average. In addition, these firms may have been 
relatively larger firms so that they may not be fully representative of 
the industry. Also, FDA does not know whether or not these firms would 
necessarily be in full compliance with the proposed regulations so that 
additional costs might have to be expended.
2. Costs: MSSP Study
    The MSSP study provides FDA with survey data from which detailed 
cost estimates have been made in the PRIA, subject to numerous 
uncertainties. As this is the largest and only randomly selected data 
base available to FDA, the PRIA relied primarily on estimates based on 
these data. The contractor in the MSSP study sent teams into 130 
processing plants, none of which were operating under HACCP systems, to 
project the costs to each plant to implement and operate a form of 
HACCP chosen for that study.
    In areas where FDA had better data than that used in the contractor 
reports, the agency has used information available from its field 
surveys on current practices or conditions in the industry in general, 
and it has substituted that information for the information gathered 
from the sample plants in the contractor reports. Where gaps in the 
contractor estimates exist that could not be filled in by information 
from FDA field surveys, a number of assumptions have been made for the 
purposes of this economic assessment. FDA views the cost estimates 
extrapolated from the contractor reports and other sources as 
preliminary and requests comments on them.
    From FDA's 1992 official establishment inventory, FDA has estimated 
that there are 4,846 domestic seafood manufacturing plants that will be 
affected by the proposed rule. Thirty-three percent of the first year 
costs can be attributed to expenditures necessary to comply with the 
HACCP-based sanitation provisions of the proposed rule. Another 36 
percent are attributable to monitoring and recordkeeping requirements. 
In addition, approximately 31 percent of the first year costs are for 
equipment such as temperature indicators, temperature recorders, and 
can seam tear-down machines. Additional costs are for HACCP training, 
consulting by processing authorities, writing HACCP plans, instituting 
operational changes, responding to critical limit deviations, and 
analytical testing. The average expected cost of the proposed rule per 
domestic manufacturing plant is estimated to be $23,900 in the first 
year ($24,000 for small plants, $23,400 for large plants) and $15,000 
in the following years ($14,700 for small plants and $15,700 for large 
plants). Total costs of the proposed rule for domestic manufacturers 
are estimated to be $117 million in the first year and $65 million in 
the following years.
    In addition, FDA estimates that 924 importers will bear start-up 
costs of approximately $8 million, and 1,571 repackers and warehouses 
will bear annual recurring costs of $14 million. Therefore, based on 
these data, FDA estimates domestic costs for this rule to be $139 
million in the first year and $79 million in succeeding years. 
Discounted domestic costs are estimated to be $676 million over 10 
years (6 percent). FDA also estimates that 8,125 foreign processors 
will have initial costs of $96 million and recurring costs of $44 
million.
    Should smoked fish products be required to bear refrigeration 
statements on their labels, the maximum possible cost to this industry 
segment would be estimated to be $2.5 million for a label redesign for 
all products. A label redesign would be likely only in the case of 
extensive refrigeration instructions. If a simple statement such as 
``keep refrigerated'' were to be required, then the cost to the smoked 
fish industry would be approximately $168,000 because approximately 75 
percent of the products currently bear such statements.
    These estimates are considerably higher than the estimates from 
data submitted to FDA from seafood plants as discussed above. These 
differences may be attributable to several factors. For example, the 
MSSP-based estimates also include estimated costs of compliance by 
processors with pre-existing sanitation requirements in part 110 and 
costs of complying with guidelines that are appended to these proposed 
regulations. Although these costs are not inherent to the operation of 
a HACCP system, they represent one-third of the total MSSP-based 
estimates. As indicated earlier in this document, compliance with 
CGMP's for sanitation has been a continuing problem across the 
industry. For this reason, FDA is proposing specific sanitation 
requirements in subpart A of part 123.
    Moreover, the estimate of costs associated with complying with 
guidelines in the appendices may be overstated because, in actuality, 
FDA may find industry practices other than those stated in the 
guidelines to be acceptable. The guidelines are intended to provide the 
industry with information on how it could implement HACCP, not how it 
must do so.
    Costs to importers and to foreign processors that ship to the 
United States were also estimated. In the absence of reliable data for 
estimating costs to foreign processors, FDA estimated the number of 
plants that export seafood to the United States and based their costs 
of implementing HACCP on MSSP- generated data on the costs to U.S. 
plants.
    It is important to recognize that many of the United States major 
seafood trading partners are using, or have opted for, HACCP programs. 
For example, the EC will soon require HACCP or an equivalent system 
from over 100 nations that export to it. Consequently, with the current 
trend toward HACCP worldwide, the costs to many foreign processors of 
implementing HACCP may be incurred regardless of whether FDA issued 
these proposed regulations. Moreover, in the near future, U.S. 
importers subject to this proposed rule should have little difficulty 
finding products produced under HACCP. FDA specifically invites comment 
on the estimated costs of the proposed regulations to importers and 
foreign processors, e.g., whether they are high due to the worldwide 
move toward HACCP or whether they are low due to other factors that 
have not been considered, and the potential effect on U.S. consumers of 
requiring that imports be produced under HACCP systems.
    The PRIA presumes that most of the cost of compliance of the 
proposed regulations will be passed on to consumers. Estimating the 
magnitude of these price increases is difficult. U.S. consumers spent 
about $16.5 billion on domestically produced seafood in 1991 (Ref. 42). 
If the domestic industry passed on all of the estimated annual costs to 
consumers, prices for domestically produced seafood would increase by 
less than 1 percent in the first year and less than one-half of 1 
percent in succeeding years. Price changes of such magnitude are 
unlikely to have a major impact on general seafood purchases. However, 
some regional price increases may considerably exceed this. In 
addition, this estimation of change in price does not address potential 
concentration effects. It is worth noting that the contractor that 
performed the MSSP study estimated a range of cost increases from 
negligible to 1.3 percent, depending on the type of product.
    The effect on prices of imported products is impossible to 
estimate. While the PRIA uses MSSP data and a number of assumptions to 
estimate possible costs to foreign processors of complying with the 
proposed regulations, those costs will be spread among the consumers 
from all nations to which these processors export. FDA is unable to 
estimate what percentage of these costs would be passed on to U.S. 
consumers.
    On the other side of the ledger, the MSSP-based estimates were not 
able to include costs associated with some features of the proposed 
rules because data were lacking. An inventory of these features is 
provided in the PRIA, and FDA invites comment on possible costs 
associated with them. They include prevention of cross contamination by 
the separation of food contact surfaces, storage at 40  deg.F of 
cooked, ready-to-eat products and products that are made in whole or in 
part of scombroid toxin forming species, and the costs of following the 
approach presented in the guidelines at Appendix B for scombroid toxin 
forming species.

C. Benefits

    This proposed action will reduce the amount of illness that derives 
from consumption of seafood (safety benefits) and may have significant 
nutrition benefits that result from increased consumption of seafood. 
The increased consumption will result from a decrease in consumer 
anxiety associated with the consumption of seafood. In addition, there 
may be significant cost savings (benefits) in other areas as a result 
of adoption of this proposed rule.
    The existence of a national, mandatory, HACCP-based inspection 
system for seafood should have a beneficial, although nonquantifiable 
effect on both the industry and the Federal government. FDA knows from 
experience that continuing concerns about the adequacy of the current 
Federal regulatory system for seafood place a financial stress on 
industry, which must constantly defend itself from criticism, and on 
regulatory agencies such as FDA, which must divert resources in order 
to respond to the Congress and the media. While public interest in food 
safety is healthy and desirable, the extreme interest in seafood 
safety, which has manifested itself in over 10 congressional hearings 
and over 20 pieces of legislation in the past 5 years, demonstrates how 
a system that is less than fully adequate from the public's standpoint 
can cause a steady diversion of both public and private resources that 
is likely to continue in the absence of a system that overcomes current 
inefficiencies and shortcomings.
    Finally, there will be an additional benefit to firms wishing to 
export seafood to those countries which require federally monitored 
HACCP. The latter two benefits have not been quantified, and FDA 
requests comments on how this might be done.
    The agency followed three steps to quantify the safety benefits of 
HACCP for processors: (1) Identify all significant hazards associated 
with seafood safety and establish the baseline number of incidents of 
each hazard in the U.S. population; (2) estimate the reduction in the 
number of incidents of each hazard that HACCP is expected to 
accomplish; and (3) quantify the benefit of the reduced illnesses and 
deaths. In all three steps, FDA acknowledges that there is substantial 
uncertainty.
    First, to establish a baseline number of illnesses, FDA reviewed 
both reported data to the CDCP, which provides a lower bound on the 
actual number of cases, and an earlier FDA risk assessment that 
estimated an upper-bound number of cases. Using information about the 
probable amount of underreporting for each type of illness, FDA 
constructed a likely baseline number for each type of illness by 
inflating these numbers between zero and 1,000 times the amount 
reported. Thus, for example, while it is likely that nearly all cases 
of neurotoxic shellfish poisoning (NSP) are reported to CDCP, it is 
likely that Campylobacter jejuni is underreported by approximately 100 
times the actual number of cases. This approach for estimating cases 
yielded an estimated 33,000 cases of illness from seafood per year. 
However, FDA acknowledges that even a reasonably precise estimate of 
the number of illnesses cannot be determined with the existing 
foodborne disease reporting mechanisms in this country.
    In the second step, FDA used a panel of internal experts to 
determine the number of illnesses the proposed regulations are likely 
to reduce.\1\ For example, it is not likely to reduce any cases of NSP 
because they are primarily associated with recreational fishing. On the 
other hand, it is likely to reduce over 50 percent of scombroid 
poisoning because most of the mishandling of seafood comes either at 
the catch or processing stages. This action will not reduce any cases 
that are a result of consumer or retailer mishandling but, as explained 
earlier in this document, problems at the retail level are addressed 
through mechanisms outside of this proposed regulation. FDA has 
estimated that between 5,000 and 19,000 cases of seafood illness and 
death will be reduced by the proposed action annually.
---------------------------------------------------------------------------

    \1\Memorandum to Richard A. Williams, Jr., November 17, 1993.
---------------------------------------------------------------------------

    In the third step, FDA used economic valuation techniques to 
quantify the effect of reducing the range of cases of seafood illness. 
This technique combines costs of illness, such as hospital costs, with 
the costs of pain and suffering in a reduced health state to estimate 
the cost of each hazard. Thus, for example, NSP, with very mild 
symptoms, has a low cost per case ($270), whereas Vibrio vulnificus, 
with a high probability of death, has a very high cost ($1.3 million 
per case). Using this methodology, the total safety benefits of the 
proposed option are valued between $15 and $75 million per year.
    FDA has also evaluated the potential health benefits associated 
with increased consumption of seafood. Because of the negative 
publicity concerning water pollution and seafood safety, consumer 
perception of seafood safety may overestimate actual risk. In addition, 
contamination scares cause drastic short-term drops in consumer demand 
for seafood products and undoubtedly contribute to the chronic level of 
consumer concern about seafood safety. Thus, safety concerns about 
seafood are a likely factor preventing wider consumer acceptance of 
seafood as part of the U.S. diet.
    If this proposal is finalized, consumer concerns about seafood 
safety may be reduced which may, in turn, lead to increased consumption 
of seafood. FDA has evaluated the possibility that consumers may switch 
from higher fat flesh protein, such as meat and poultry, to seafood. 
The resulting reduced dietary fat in the diet of the general population 
would result in reduced incidence of coronary heart disease and cancer. 
Using the same methodology employed in an earlier analysis of the 
Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535), FDA 
analyzed the benefits of a 1- and 5-pound per capita increase in 
consumption of seafood. These were estimated to decrease deaths by 673 
and 2,782, respectively, over a 10-year period. The resulting benefits 
are valued at $3 and $14 billion.

D. Small Business Impact

    The proposed rule will have a substantial impact on small seafood 
processors as defined by the Regulatory Flexibility Act. Eighty percent 
of the seafood processors covered by this proposed regulation are 
small, where small is defined for nonshrimp firms as less than $1 
million in annual gross revenue and less than $2 million for shrimp 
firms. The provisions of this rule, such as monitoring and 
recordkeeping, are largely fixed costs (costs which do not vary 
significantly with the amount of the product produced) which will 
impose larger per unit costs on small rather than on large businesses. 
In addition, small firms may have as many critical control points as 
large firms because critical control points tend to be related to the 
complexity of the operation, not the size of the business. However, it 
may be that smaller firms are less complex than large firms, although 
the agency does not have sufficient data to determine if this is so.
    In some cases the increase in cost will be large enough to cause 
some firms to go out of business. For example, estimates of firm 
failure have been as low as 2 percent (96 firms) of all firms (from the 
Canadian experience) to 334 firms (estimated for compliance with MSSP). 
However, FDA does not have enough information to estimate the number of 
firms that will close if the proposed rule becomes final.
    There are several factors that affect the ability of small 
processors to comply with the proposed regulations. First, the basic 
HACCP requirements proposed in subpart A of part 123 deliberately 
include only the essentials of HACCP in order to keep fixed costs to a 
minimum. Second, FDA is developing considerable guidance in the form of 
a hazard guide and model HACCP plans to enable small processors to 
implement an effective HACCP system at the lowest possible cost. Third, 
FDA is also aware that academia and trade associations are available to 
assist processors to implement HACCP. Finally, for those small 
processors that have very simple operations requiring few critical 
control points, an inherent feature of HACCP is that it adjusts to the 
complexity and risks of an operation.
    While any closure is regrettable, the agency strongly believes that 
firms that are unable to identify the likely hazards associated with 
their products and take reasonable preventive controls to prevent those 
hazards from occurring should not be selling food in interstate 
commerce. As described in the preamble, FDA is keenly interested in 
keeping the costs of implementing HACCP to a minimum and is issuing 
guidance documents and model HACCP plans to facilitate such 
implementation.
    FDA is specifically requesting comment in areas where costs and 
benefit estimates are either very uncertain or potentially large. FDA 
will utilize answers received on these comments along with all other 
comments to help formulate the final rule.
1. Costs
    FDA specifically requests comments on:
    (1) The expected cost to retrofit plants as necessary for the 
proper operation of HACCP controls (e.g., enhance refrigerator 
capacity, water supply changes, etc.).
    (2) The cost of taking corrective actions to respond to critical 
limit deviations on an annual basis. FDA has estimated an average of 
$1,000 per firm to take such actions as discarding product, buying new 
equipment, and changing the processing practice.
    (3) The cost of training employees. FDA has estimated that there 
will be a cost per plant of $900 to train an employee to manage HACCP. 
This will include the cost of training, travel expenses, and loss of 
several days of productivity for that employee. Not all of these costs 
may be borne by manufacturers, however, because some training may be 
sponsored by academia, trade associations, and others.
    (4) The cost of ensuring that cooking and pasteurizing equipment 
and processes are achieving the desired safety results (i.e., 
destroying microbiological pathogens). This ensurance may be obtained 
by having equipment and processes that are equivalent to those found 
effective by a processing authority. FDA estimated that this would cost 
$1,000 per plant in the first year and, on average, half that amount in 
the following years as processors change their processes and equipment. 
This cost may be offset, however, by reliance on literature that 
contains the necessary information from a processing authority.
    (5) The cost of temperature indicators and thermometers for plants 
who do not now have this equipment. FDA estimated that the cost would 
be $1,000 per plant, initially, with replacement as necessary.
    (6) The cost of creating a HACCP plan from the guidance provided by 
FDA. FDA estimated that it will take processors with simpler processes 
24 hours of managerial time to adapt the guidance into a HACCP plan. 
FDA estimated that it will take processors with more complex processes 
72 hours of managerial time to adapt the guidance into a HACCP plan.
    (7) FDA requests comment on the recordkeeping burden associated 
with the proposed sanitation requirements in Sec. 123.10 (b) and (c). 
If possible, such estimates should be provided in terms of hours spent 
and translated into dollars if staff compensation rates are known.
    In addition, FDA was unable to provide cost estimates of the 
following provisions and requests specific comments on these areas:
    (1) Section 123.10(a)(7), prevention of cross-contamination by the 
separation of food-contact surfaces;
    (2) Section 123.10(a)(14), storage at 40  deg.F or below;
    (3) Appendix A.6., cooling after cooking;
    (4) Appendix B., scombroid toxin forming species;
    (5) Appendix 1., specifically, the guidance on smoked and smoke-
flavored fishery products;
    (6) Increased short-term recall potential, if any, due to 
heightened industry awareness;
    (7) Increasing time spent escorting Federal inspectors, 
particularly in the initial phases;
    (8) The cost of restricting catch in certain areas and seasons if 
processors find it necessary.
2. Benefits
    (1) FDA is reprinting two tables from the PRIA and requests 
comments on both the baseline number of illnesses due to seafood and 
the likelihood that HACCP for processors will reduce those illnesses. 
The baseline number of illnesses reflects an estimate of all cases 
(from any source, including recreational harvest, retail, and consumer 
mishandling). FDA considers the estimates in both tables as preliminary 
estimates.

          Table 1.--Significant Hazards Associated With Seafood         
       [All Seafood Sources Combined--Recreational and Commercial]      
------------------------------------------------------------------------
                                     Reported   Upper-bound   Estimated 
             Hazards                  cases        cases        cases   
                                    (annual)     (annual)     (annual)  
------------------------------------------------------------------------
Anasakis.........................          1          100          100  
Campylobacter jejuni.............          2          200          200  
Ciguatera........................        800        8,000          800  
Clostridium botulinum............          4            4            4  
Clostridium perfringens..........          7           70           70  
Diphyllobothrium latum...........      (\1\)        1,000        1,000  
Giardia..........................          3           50           30  
Hepatitis A virus................          9.2      6,700           92  
Neurotoxic shellfish poisoning...         48           48           48  
Norwalk virus....................         12.4     30,000       12,400  
Other Vibrios....................         43       10,000       10,000  
Paralytic shellfish poisoning....         13.4         13.4         13.4
Salmonella nontyphi..............          2        2,750          200  
Scombrotoxin.....................        796       21,500        7,960  
Shigella.........................          7          100           70  
Vibrio vulnificus................         24           48          48   
                                  --------------------------------------
    Total........................      1,772       80,389      33,035   
------------------------------------------------------------------------
\1\Unknown.                                                             


    Table 2.--Projected Number of Cases Averted Using HACCP Approach    
------------------------------------------------------------------------
                                       FDA best                         
                                       estimate    Number of   Number of
              Hazards                   of the       cases       cases  
                                       number of    averted     averted 
                                         cases     (lower)*    (upper)**
------------------------------------------------------------------------
Anasakis............................         100          10        75  
Campylobacter jejuni................         200         100       150  
Ciguatera...........................         800          50       100  
Clostridium botulinum...............           4           0         1  
Clostridium perfringens.............          70          53        70  
Diphyllobothrum latum...............       1,000         250       750  
Giardia.............................          30           0         7.5
Hepatitis A virus...................          92          15        46  
Neurotoxic shellfish poisoning......          48           0         0  
Norwalk virus.......................      12,400       1,000     6,200  
Other Vibrios.......................      10,000       1,000     5,000  
Paralytic shellfish poisoning.......          13           0         0  
Salmonella nontyphi.................         200         100       150  
Scombrotoxin........................       7,960       3,980     5,970  
Shigella............................          70          18        35  
Vibrio vulnificus...................          48           0        24  
                                     -----------------------------------
    Total...........................      33,035       6,575   18,679   
------------------------------------------------------------------------
*Estimates by Klontz and Altekruse.                                     
**Estimates by Archer.                                                  
\1\Memorandum to Richard A. Williams, Jr., November 16, 1993.           

    (2) FDA also specifically requests comments on the number of cases 
of illness included in the baseline estimate (33,035) that may be due 
to factors outside the processors' control, such as those due to 
recreational harvests (that are not eventually sent to processors), 
those due to restaurants and supermarkets, and those due to consumer 
mishandling.
    (3) As mentioned above, FDA has also estimated potential benefits 
associated with increased seafood consumption. These benefits will only 
be realized if the price increase resulting from this rule does not 
offset the effect of increased demand for seafood which will result 
from reduced consumer anxiety. FDA requests specific comment on the 
likelihood that seafood consumption will be increased as a result of 
this rule.
    (4) FDA has identified but not quantified benefits to seafood 
exporters as well as reduced public anxiety associated with the safety 
of seafood. FDA requests comments on these benefits (including how to 
quantify them) as well as other potential benefits such as how HACCP 
will help firms gain better control over their operations, better 
sanitation and greater efficiencies such as reduced product waste.

E. Tribal Governments

    FDA is aware that some tribal governments are involved in the 
processing of seafood for interstate commerce. The agency expects that 
the proposed regulations will apply to them in such cases. Executive 
Order 12875 of October 26, 1993, requires, among other things, 
consultation with tribal governments before the formal promulgation of 
regulations containing unfunded Federal mandates. While FDA does not 
believe that the proposed regulations would impose an unfunded Federal 
mandate, the agency wishes to foster consultation on matters that might 
significantly affect tribal communities. Consequently, FDA specifically 
requests comment on the economic effect of the proposed regulations on 
tribal governments.

F. Availability of PRIA/RFA

    FDA acknowledges considerable uncertainty in both cost and benefit 
estimates of the proposed regulations and requests comment on all 
aspects of the PRIA and the RFA. The full PRIA/RIA is available at the 
Dockets Management Branch (address above).

XI. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

XII. Request for Comments

    Interested persons may, on or before April 28, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.



XIII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

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1991.

List of Subjects

21 CFR Part 123

    Fish, Fishery products, Imports, Reporting and recordkeeping 
requirements, Seafood.

21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supply.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR chapter I be amended as follows:
    1. Part 123 is added to read as follows:

PART 123--FISH AND FISHERY PRODUCTS

Subpart A--General Provisions

Sec.
123.3  Definitions.
123.5  Current good manufacturing practice (sanitation).
123.6  Hazard Analysis Critical Control Point (HACCP) plan.
123.7  Corrective actions.
123.8  Records.
123.9  Training.
123.10  Sanitation control procedures.
123.11  Obligations of importers.
123.12  Imports--determination of compliance.

Subpart B--[Reserved]

Subpart C--Raw Molluscan Shellfish

123.20  General.
123.28  Source controls and records.

Appendix A to Part 123--Cooked, Ready-to-eat Fishery Products
Appendix B to Part 123--Scombroid Toxin Forming Species
Appendix C to Part 123--[Reserved]
Appendix D to Part 123--Product Integrity

    Authority: Secs. 201, 402, 403, 406, 409, 701, 704, 721, 801 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 
346, 348, 371, 374, 379e, 381); secs. 301, 307, 361, 1702 of the 
Public Health Service Act (42 U.S.C. 241, 242l, 264, 300u-1).

Subpart A--General Provisions


Sec. 123.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act and in part 110 of this chapter 
are applicable to such terms when used in this part. The following 
definitions shall also apply:
    (a) Certification number means a unique combination of letters and 
numbers assigned by a shellfish control authority to a molluscan 
shellfish processor.
    (b) Cooked, ready-to-eat fishery product means 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.
    (c) Critical control point means 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.
    (d) Critical limit means the 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.
    (e) Fish means fresh or saltwater finfish, molluscan shellfish, 
crustaceans, and other forms of aquatic animal life other than birds or 
mammals.
    (f) Fishery product means any edible human food product derived in 
whole or in part from fish, including fish that has been processed in 
any manner.
    (g) Harvester means a person who has an identification number 
issued by a shellfish control authority for commercially taking 
molluscan shellfish by any means from a growing area.
    (h) Importer means a person, or his representative in the United 
States, who is responsible for ensuring that goods being offered for 
entry into the United States are in compliance with all laws affecting 
the importation.
    (i) Lot of molluscan shellfish means a collection of shellstock or 
containers of shellstock of no more than 1 day's harvest from a single, 
defined growing area harvested by one or more harvesters.
    (j) Molluscan shellfish means any edible species of fresh or frozen 
oysters, clams, mussels and scallops or edible portions thereof, except 
when the scallop product consists entirely of the shucked adductor 
muscle.
    (k) Potable water means water which meets the U.S. Environmental 
Protection Agency's Primary Drinking Water Regulations as set forth in 
40 CFR part 141.
    (l) Process control instrument means an instrument or device used 
to monitor conditions during processing at a critical control point.
    (m) Processing means, with respect to fish or fishery products, 
handling, storing, preparing, heading, gutting, shucking, freezing, 
changing into different market forms, manufacturing, preserving, 
packing, labeling, or holding. Practices such as heading or gutting 
intended solely to prepare a fish for holding on board a harvest vessel 
are excluded. This regulation does not cover the operation of a retail 
establishment.
    (n) Processor means any person engaged in commercial, custom, or 
institutional processing of fish or fishery products, either in the 
United States or in a foreign country. Persons engaged in the 
production of foods that are to be used in market or consumer tests are 
also included. Persons who only harvest or transport seafood, without 
otherwise engaging in processing, are not covered by these regulations.
    (o) Shall is used to state mandatory requirements.
    (p) Shellfish control authority means a Federal or State health 
authority, or foreign government health authority, legally responsible 
for the administration of a program that includes classification of 
molluscan shellfish growing areas, enforcement of harvesting controls, 
and certification of molluscan shellfish processors.
    (q) Shellstock means raw, in-shell molluscan shellfish.
    (r) Should is used to state recommended or advisory procedures or 
to identify recommended equipment.
    (s) Shucked shellfish means molluscan shellfish that have one or 
both shells removed.
    (t) Tag means a record of harvesting information attached to a 
container of shellstock by the harvester or processor.


Sec. 123.5  Current good manufacturing practice (sanitation).

    (a) The criteria in part 110 of this chapter apply in determining 
whether the facilities, methods, practices, and controls used to 
process fish and fishery products are safe, and whether these products 
have been processed under sanitary conditions.
    (b) The purpose of subpart A of this part is to set forth 
requirements specific to the processing of fish and fishery products.


Sec. 123.6  Hazard Analysis Critical Control Point (HACCP) plan.

    (a) Every processor and importer shall have and implement a written 
HACCP plan that is specific to:
    (1) Each location where fish and fishery products are processed by 
that processor; and
    (2) Each kind of fish and fishery product processed by the 
processor. The plan may group kinds of fish and fishery products 
together if the hazards, critical control points, critical limits, and 
procedures required to be identified in paragraph (b) of this section 
are identical for all fish and fishery products so grouped.
    (b) The HACCP plan shall:
    (1) Identify the safety hazards that are reasonably likely to occur 
and that thus must be controlled for each fish and fishery product, 
including, as appropriate:
    (i) Natural toxins;
    (ii) Microbiological contamination;
    (iii) Chemical contamination;
    (iv) Pesticides;
    (v) Drug residues;
    (vi) Decomposition;
    (vii) Parasites;
    (viii) Unapproved direct and indirect food and color additives; and
    (ix) Physical hazards;
    (2) Identify the critical control points for each of the identified 
hazards;
    (3) Identify the critical limits that must be met at each of the 
critical control points;
    (4) Identify the procedures, and frequency thereof, including the 
use of consumer complaints received by the processor or importer, that 
will be used to control and monitor each of the critical control points 
to ensure compliance with the critical limits. Such procedures shall 
include the calibration of process control instruments and validation 
of software for computer control systems as appropriate;
    (5) Provide for a recordkeeping system that will document the 
monitoring of the critical control points. The records shall contain 
the actual values obtained during monitoring. The records shall also 
include consumer complaints that relate to the operation of critical 
control points or possible critical limit deviations.
    (c) In addition, the HACCP plan should:
    (1) Identify other consumer hazards not related to the safety of 
the product, including, but not necessarily limited to:
    (i) Decomposition not associated with human illness; and
    (ii) Economic adulteration.
    (2) Provide for control of these hazards in the manner described by 
paragraphs (b)(2) through (b)(5) of this section.
    (d) Failure of a processor or importer to have and implement an 
HACCP plan that complies with this section or to operate in accordance 
with the requirements of this part, shall render the products of that 
processor or importer adulterated under section 402(a)(4) of the 
Federal Food, Drug, and Cosmetic Act.


Sec. 123.7  Corrective actions.

    (a) Any critical limit deviation shall require:
    (1) Segregation and holding of the affected product, at least until 
the requirements of paragraphs (a)(2) and (a)(3) of this section are 
met;
    (2) Immediate review by an individual or individuals who have been 
trained in accordance with Sec. 123.9, to determine the acceptability 
of the lot in question for distribution, based on a judgment as to 
whether the deviation may have rendered the product in that lot 
injurious to health or otherwise adulterated;
    (3) Corrective action, when necessary, with respect to the affected 
product and the critical control point at which the deviation occurred;
    (4) Timely assessment by an individual or individuals who have been 
trained in accordance with Sec. 123.9, to determine whether the process 
or Hazard Analysis Critical Control Point (HACCP) plan needs to be 
modified to reduce the risk of recurrence of the deviation; and
    (5) Modification when necessary as it applies to the process or 
HACCP plan.
    (b) 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 shall determine whether 
corrective action as described by paragraph (a) of this section is 
appropriate and, if so, it shall take such action.
    (c) All actions required by paragraphs (a) and (b) of this section 
shall be documented in records that are subject to the requirements of 
Sec. 123.8.


Sec. 123.8  Records.

    (a) Records required by this part that involve observations or 
measurements during processing or related activities, including 
corrective actions taken in accordance with Sec. 123.7, shall include 
the identity of the product, product code, and date of activity that 
the record reflects. Processing and other information shall be entered 
at the time that it is observed. Each record shall be signed by the 
operator or observer, except that corrective action records need only 
be signed in accordance with paragraph (b) of this section.
    (b) Records required by this part shall be reviewed, signed, and 
dated by an individual who has been trained in accordance with 
Sec. 123.9, before distribution of the product for completeness and 
compliance with the established critical limits.
    (c) The records required by this part shall be retained at the 
processing facility or the importer's place of business in the United 
States for at least 1 year after the date they were prepared in the 
case of refrigerated products and for at least 2 years after the date 
they were prepared in the case of frozen or preserved products. Records 
that relate to the general adequacy of equipment or processes being 
used by a processor, including the results of scientific studies and 
evaluations, shall be retained at the processing facility for at least 
2 years after their applicability to the product being produced at the 
facility. If the processing facility is closed between seasonal packs, 
the records may be transferred to some other reasonably accessible 
location during the period of closure.
    (d) All records required by this part, including HACCP plans 
required in Sec. 123.6 and consumer complaints that may be related to a 
critical limit deviation, shall be available for review and copying at 
reasonable times by duly authorized officers and employees.
    (e) Tags as defined in Sec. 123.3(t) are not subject to the 
requirements of this section.


Sec. 123.9  Training.

    Each processor and importer shall employ at least one individual 
who has successfully completed a prescribed course of instruction in 
the application of Hazard Analysis Critical Control Point (HACCP) 
principles to fish and fishery product processing at a program of 
instruction approved by the Food and Drug Administration. At a minimum, 
this individual shall be responsible for developing and modifying the 
plan as required by Sec. 123.6, evaluating critical limit deviations 
and corrective actions as required by Sec. 123.7, and performing record 
review as required by Sec. 123.8(b).


Sec. 123.10  Sanitation control procedures.

    (a) Every processor and importer who takes physical possession of 
fish or fishery products and engages in the processing of such fish or 
fishery products, including storing such products, shall perform 
sanitation inspections and ensure at a minimum that, to the extent 
applicable to the operations conducted by the processor or importer, 
the following conditions apply:
    (1) Water that directly comes into contact with a product or with 
food contact surfaces, or is used in the manufacture of ice, is derived 
from a safe and sanitary source or is being treated to render it of 
safe and sanitary quality.
    (2) There are no cross connections between the potable water system 
and any nonpotable system.
    (3) All food contact surfaces of plant equipment and utensils, 
including equipment used for ice production and storage, are so 
designed and of such material and workmanship as to be easily 
cleanable, and are maintained in a sanitary condition. Such surfaces 
shall be constructed of nontoxic materials and designed to withstand 
the environment of its intended use and the action of the food, 
cleaning compounds, and sanitizing agents.
    (4) All utensils and surfaces of equipment that contact food during 
processing are cleaned and sanitized with effective cleaning and 
sanitizing preparations with the following frequency:
    (i) Cleaned at the end of the day's operations;
    (ii) Cleaned and sanitized at least every 4 hours during the 
processing of cooked, ready-to-eat fishery products; and
    (iii) Sanitized before the beginning of the day's operations.
    (5) Gloves and outer garments that contact food or food contact 
surfaces are made of an impermeable material and are maintained in a 
clean and sanitary condition.
    (6) Employees' hands, gloves, outer garments, utensils and food 
contact surfaces of equipment that come into contact with waste, the 
floor, or other insanitary objects, do not contact fish or fishery 
products without first being adequately cleaned and sanitized.
    (7) Where applicable, employee's hands, gloves, outer garments, 
utensils and food contact surfaces of equipment that come into contact 
with raw product shall not contact cooked product or ice used on cooked 
product, without first being adequately cleaned and sanitized.
    (8) Hand washing and hand sanitizing facilities are:
    (i) Located in all processing areas in which good sanitary practice 
requires employees to wash and sanitize their hands; and
    (ii) Equipped with hand-cleaning and effective sanitizing 
preparations and single service towels or suitable hand drying devices.
    (9) Food, food contact surfaces, and food-packaging materials shall 
be protected from adulteration with lubricants, fuel, pesticides, 
cleaning compounds, sanitizing agents, metal fragments, or other 
chemical or physical contaminants.
    (10) Toxic compounds shall be identified, held, used, and stored in 
a manner that protects against contamination of food, food-contact 
surfaces, or food-packaging materials.
    (11) Food, food-contact surfaces, and food-packaging materials 
shall be protected from contaminants that may drip, drain, or be drawn 
into the food.
    (12) Compressed gases that contact food or food contact surfaces of 
equipment shall be filtered or treated in a way that ensures that they 
will not contaminate the food with unapproved indirect food additives 
or other chemical, physical, or microbiological contaminants.
    (13) Unprotected cooked, ready-to-eat fishery products, smoked 
fishery products, raw molluscan shellfish, and raw fish and fishery 
products shall be physically separated from each other during 
refrigerated storage.
    (14) Refrigeration units that store raw materials, in-process, or 
finished fish or fishery products that are cooked, ready-to-eat, 
smoked, or made in whole or in part from scombroid toxin forming 
species shall be operated at a temperature of 40  deg.F (4.4  deg.C) or 
below.
    (15) Any person who, by medical examination or supervisory 
observation, is shown to have, or appears to have, an illness, open 
lesion, including boils, sores, or infected wounds, or any other source 
of microbial contamination by which there is a reasonable possibility 
that food, food-contact surfaces, or food-packaging materials will 
become contaminated, shall be excluded from any operations that may be 
expected to result in such contamination until the condition is 
corrected.
    (16) Adequate, readily accessible toilet facilities that provide 
for proper sewage disposal shall be available and maintained in a 
sanitary condition and in good repair.
    (17) No pests are in any area of a food plant.
    (18) The plant is designed to minimize the risk of contamination of 
the food, food-contact surfaces, and food-packaging material.
    (b) Each processor shall maintain sanitation control records that 
document that the steps required under paragraph (a) of this section 
are performed with requisite frequency.
    (c) Sanitation control measures shall be taken on a daily basis, 
and the sanitation control records shall be prepared according to the 
requirements of paragraph (a) of this section, except that:
    (1) The hand sanitizer strength and sanitary practices of the 
processing employees, especially as these relate to hand washing and 
sanitizing practices and the potential for cross contamination, shall 
be checked and recorded at least every 4 hours during processing.
    (2) All utensils and food-contact surfaces of equipment shall be 
inspected immediately after each cleaning and sanitizing operation 
under paragraph (a)(4)(ii) of this section. Each such cleaning and 
sanitizing shall be documented, and such documentation shall at a 
minimum record the time of each cleaning, the concentration of the 
sanitizer, and the condition of the equipment.
    (3) The requirements of paragraphs (a)(1), (a)(2), (a)(3), 
(a)(8)(i), (a)(12), and (a)(18) of this section shall be performed and 
documented with such frequency as is necessary to ensure control.
    (4) The requirement of paragraph (a)(14) of this section shall be 
ensured by the continuous monitoring of the refrigeration unit with an 
accurate process control instrument. The instrument shall be checked 
and the measurements documented with such frequency as is necessary to 
ensure control.
    (d) Where deviations from the requirements of paragraph (a) of this 
section are noted during these inspections, appropriate corrective 
actions shall be taken and documented on the sanitation control record.
    (e) Every plant should have a written standard operating procedure 
(SOP) for assuring the maintenance of proper sanitary conditions and 
practices during processing that is specific to each fish and fishery 
product produced at that location. The SOP should include, at a 
minimum, requirements as described in paragraph (a) of this section.
    (f)(1) All fish to be smoked or salted shall be eviscerated and 
free of residual viscera, except for:
    (i) Small species of fish, such as anchovies and herring sprats, 
provided that they are processed in a fashion so that they contain a 
water-phase salt level of at least 10 percent, a water activity below 
0.85, or a pH of 4.6 or less; and
    (ii) Fish that are fully cooked before further processing.
    (2) Evisceration shall be conducted in an area that is segregated 
and separate from other processing operations. Evisceration shall be 
performed with minimal disturbance of the intestinal tract contents. 
The fish, including the body cavity, shall be washed thoroughly with a 
vigorous water spray or a continuous water flow system.


Sec. 123.11  Obligations of importers.

    This section sets forth the specific obligations of importers of 
fish and fishery products into the United States.
    (a) An importer of fish or fishery products shall have and 
implement a Hazard Analysis Critical Control Point (HACCP) plan in 
accordance with Sec. 123.6 that describes how the fish will be 
prepared, packed, or held while it is in the control of the importer.
    (b) The importer of fish or fishery products shall have on file the 
HACCP plans of each of its foreign processors.
    (c) The importer shall take affirmative steps to ensure that the 
fish and fishery products that it offers for import were produced under 
the HACCP plan that it has in its possession and subject to the 
sanitation controls listed in Sec. 123.10. Such steps may include, but 
would not be limited to:
    (1) Obtaining from the foreign processor the HACCP monitoring 
records that relate to the specific fish or fishery products being 
offered for import.
    (2) Obtaining a certificate from a foreign government inspection 
authority certifying that the firm is operating under a valid HACCP 
plan or certification on a lot-by-lot basis.
    (3) Regularly inspecting its suppliers' facilities to ensure that 
they are being operated in compliance with the applicable HACCP plan 
and Sec. 123.10.
    (4) Periodic end-product testing by the importer or a private 
laboratory hired by the importer; or
    (5) Other such verification measures as appropriate.
    (d) An importer's obligation under paragraph (c) of this section 
will be satisfied if the importer imports product from a country that 
has an active memorandum of understanding (MOU), or similar agreement, 
with FDA that documents the equivalency of the inspection system of the 
foreign country with the U.S. system. The active MOU will be expected 
to accurately reflect the current situation between the signing parties 
and be functioning and enforceable in its entirety.
    (e) Importers should encourage foreign processors to obtain HACCP 
training similar to that required by Sec. 123.9.


Sec. 123.12  Imports--determination of compliance.

    (a) There must be evidence that seafood that is offered for import 
has been produced under conditions that comply with subpart A of this 
part. Such evidence can be provided by:
    (1) Examination, at the U.S. importer's place of business, of the 
importer's Hazard Analysis Critical Control Point (HACCP) plan, the 
foreign processor's HACCP plan and sanitation procedures and records 
associated with the importer's plan that demonstrate that the plan and 
procedures were followed.
    (2) An active memorandum of understanding (as defined in 
Sec. 123.11(d)) with an exporting country that provides that the 
country will impose regulatory controls equivalent to those established 
in this part for domestic processors.
    (3) Evidence that an exporting country has in place and is 
enforcing an HACCP-based regulatory system.
    (4) Inspection of foreign processors by FDA or some other 
organization designated by FDA.
    (5) Any other measures that FDA deems appropriate, including, but 
not limited to, end-product testing.
    (b) If assurances do not exist that the product has been produced 
under an HACCP plan and sanitation controls that are equivalent to 
those required of domestic processors, the product will appear to be 
adulterated and will be denied entry.

Subpart B--[Reserved]

Subpart C--Raw Molluscan Shellfish


Sec. 123.20  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for processing fresh or frozen molluscan 
shellfish.


Sec. 123.28  Source controls and records.

    (a) In order to meet requirements of subpart A of this part as they 
apply to microbiological contamination, natural toxins, and related 
hazards, processors shall include in their Hazard Analysis Critical 
Control Point (HACCP) plans how they are controlling the origin of the 
molluscan shellfish they process.
    (b) Processors shall only process molluscan shellfish that 
originate from growing waters approved for harvesting by a shellfish 
control authority. To meet this requirement, processors shall only 
receive shellstock:
    (1) From a harvester that is licensed or a processor that is 
certified by a shellfish control authority; and
    (2) That has affixed a tag on each container of shellstock received 
by the processor that bears, at a minimum, the information required in 
Sec. 1240.60(b) of this chapter.
    (3) Bulk shellstock shipments may be identified by a bill of lading 
or similar document that contains the same information.
    (c) The same requirements that apply to shellstock shall apply to 
shucked molluscan shellfish received by a processor except that, in 
lieu of a tag, the body of the container of shucked molluscan shellfish 
shall bear a label that complies with Sec. 1240.60(c) of this chapter.
    (d) Processors shall maintain records that document that each lot 
of molluscan shellfish meet the requirements of paragraphs (b) and (c) 
of this section.
    (1) For shellstock these records shall document:
    (i) The date of harvest;
    (ii) The location of harvest by State and site;
    (iii) The quantity and type of shellfish;
    (iv) The date of receipt by the processor; and
    (v) The name of the harvester and identification number.
    (2) For shucked shellfish these records shall document:
    (i) The date of receipt;
    (ii) The quantity and type of shellfish; and
    (iii) The name and certification number of the shipper.

Appendix A to Part 123--Cooked, Ready-to-Eat Fishery Products

    1. General guidelines for cooked, ready-to- eat fishery 
products.
    2. Definitions in Appendix A.
    3. Critical control points.
    4. Thermal processing critical control points.
    5. Container integrity critical control points.
    6. Time and temperature critical control points.
    7. Temperature monitoring equipment.
    8. Corrective actions.
    9. Sanitary zones.

1. General Guidelines for Cooked, Ready-to-Eat Fishery Products

    This Appendix provides guidance on how to meet the requirements 
of 21 CFR part 123, subpart A for the processing of cooked, ready-
to-eat fishery products. Cooked, ready-to-eat fishery products are 
those that are 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. This guidance 
involves processing procedures that are common to most of these 
products for the control of the microbiological hazards to which 
they are particularly susceptible. The guidance does not apply to 
environmental or other hazards that might occur before the processor 
takes possession of the product or raw materials. (Guidance on these 
hazards may be found in a separate guidance document for all fish 
and fishery products to be issued by FDA.) This guidance also does 
not apply to cooked, ready-to-eat fishery products covered by 21 CFR 
part 123, subpart B.

2. Definitions in Appendix A

    a. Cooking process means the application of sufficient heat for 
a sufficient period of time to a fish or fishery product to 
coagulate the protein throughout the product.
    b. Hermetically sealed package means a container that is 
designed and intended to be secure against the entry of 
microorganisms.
    c. Microorganisms of public health significance means bacteria, 
fungi, and viruses capable of producing illness if they or their 
toxins are ingested by humans.
    d. Pasteurization means a process applied to a fish or fishery 
product after that fish or fishery product has been placed in a 
final, hermetically sealed package, which involves the application 
of sufficient heat or other processes for a sufficient period of 
time to result in the reduction of microorganisms of public health 
concern to levels that, under normal conditions of storage, are 
unlikely to cause disease.
    e. Process authority means a person having expert knowledge of 
commercial processing of fish and fishery products based on a 
combination of education, training and experience.
    f. Raw materials means fish and fishery products that are 
received for processing and include fishery products that have been 
processed elsewhere and that are received for further processing.
    g. Temperature-indicating device means a mercury-in-glass 
thermometer or equivalent device, such as a resistance temperature 
device or thermocouple.
    h. Temperature-recording device means a device that is capable 
of providing a continuous record of the temperature conditions being 
monitored.

3. Critical Control Points

    Hazard Analysis Critical Control Point (HACCP) plans prepared in 
accordance with 21 CFR part 123, subpart A will typically identify 
and address the following critical control points:
    a. Cooking;
    b. Pasteurization;
    c. Finished product container sealing for pasteurized products;
    d. Post-pasteurization cooling;
    e. Cooling after cooking;
    f. Processing after cooking;
    g. Final product cooling;
    h. Refrigerated storage; and
    i. Distribution.
    In accordance with 21 CFR part 123, subpart A, processors shall 
identify in their HACCP plans how they will control hazards at 
critical control points. The measures in sections 4. through 6. of 
this Appendix are suitable for HACCP plans.

4. Thermal Processing Critical Control Points

a. Cooking

    1. The Cooking Process. The processor must be able to 
demonstrate to itself and to FDA that its cooking process ensures 
the destruction of vegetative cells of microorganisms of public 
health concern. This may be accomplished by having a cooking process 
that is at least equivalent to a process established by a process 
authority. To demonstrate equivalence, a processor should have on 
file in its Hazard Analysis Critical Control Point (HACCP) records a 
document that:
    i. Describes the results of a scientific evaluation, conducted 
by a process authority, of the adequacy of the cooking process; and
    ii. Identifies and establishes values for key aspects of the 
process or of the product that may affect the adequate destruction 
of microorganisms of public health concern. At a minimum, these 
values should include cooking times and temperatures.
    Such a document may consist of, but should not be limited to, a 
letter from a process authority, articles in scientific journals, or 
Federal, State, or local government regulations or advisories. 
Failure to have documentation that the cooking process will achieve 
its goal will violate 21 CFR 123.8 and will mean that the product 
produced by the processor will be produced under insanitary 
conditions whereby it may be rendered injurious to health.
    2. Cooking Equipment Design.
    i. The processor must be able to demonstrate to itself and to 
FDA that its cooking equipment can deliver the cooking process that 
ensures the destruction of vegetative cells of microorganisms of 
public health concern. One way to accomplish this is for the 
processor to have on file in its HACCP records a document that 
describes the results of a scientific evaluation, conducted by a 
process authority, of the design and operation of the type of 
equipment and the operational procedures used by the processor. The 
engineering specifications for the equipment used by the processor 
(e.g., pipe sizes, flow rates, loading configuration, and, whenever 
a steam process is used, venting parameters) should meet or exceed 
those for the equipment evaluated by the process authority. Failure 
to have documentation that the cooking equipment will achieve its 
goal will violate 21 CFR 123.8 and will mean that the product 
produced by the processor will be produced under insanitary 
conditions whereby it may be rendered injurious to health.
    ii. Cooking equipment should be equipped with both a 
temperature-indicating device and temperature-recording device. The 
temperature-indicating device should be the reference instrument for 
determining conformance to the established process temperatures.
    3. Records.
    Monitoring records made by the processor should record both the 
actual values that are occurring for those key aspects of the 
process identified by the process authority in section 4.a.1. of 
this Appendix and the actual values that are occurring for 
operational procedures identified by the process authority in 
section 4.a.2.i. of this Appendix.
    4. Special Considerations.
    For the cooking of blue crab (Callinectes sapidus), dungeness 
crab (Cancer magister), or king crab (Paralithodes camtschatica), 
the known lethality of the cooking process necessary to make the 
product generally acceptable for human consumption, or to enable 
further processing, is sufficient so that the adequacy of the 
process and the equipment can normally be assumed.

b. Pasteurization

    1. The Pasteurization Process. The processor must be able to 
demonstrate to itself and to FDA that its pasteurization process 
ensures the adequate reduction of numbers of viable spores of 
microorganisms of public health concern. One way to accomplish this 
is to have a pasteurization process that is equivalent to a process 
established by a process authority. To demonstrate equivalence, a 
processor should have on file in its HACCP records a document that:
    i. Describes the results of a scientific evaluation conducted by 
a process authority of the adequacy of the pasteurization process; 
and that
    ii. Identifies and establishes values for those key aspects of 
the process, or of the product, that may affect the adequate 
reduction in numbers of microorganisms of public health concern. At 
a minimum, these values should include pasteurization times and 
temperatures.
    Such document may consist of, but should not be limited to, a 
letter from a process authority, articles in scientific journals, or 
Federal, State or local government regulations or advisories. 
Failure to have documentation that the pasteurization process will 
achieve its goal will violate 21 CFR 123.8 and will mean that the 
product produced by the processor will be produced under insanitary 
conditions whereby it may be rendered injurious to health.
    2. Pasteurization Equipment Design.
    i. The processor must be able to demonstrate to itself and to 
FDA that its pasteurization equipment can deliver the pasteurization 
process that ensures the adequate reduction of viable spores of 
microorganisms of public health concern. One way to accomplish this 
is to have on file a document that describes the results of a 
scientific evaluation conducted by a process authority, of the 
design and operation of the type of equipment used by the processor. 
The engineering specifications for the equipment used by the 
processor (e.g., pipe sizes, flow rates, loading configuration) 
should meet or exceed those for the equipment evaluated by the 
process authority. Failure to have documentation that the 
pasteurization equipment will achieve its goals will violate 21 CFR 
123.8 and will mean that the product produced by the processor will 
be produced under insanitary conditions whereby it may be rendered 
injurious to health.
    ii. Pasteurization equipment should be equipped with both a 
temperature-indicating device and temperature-recording device. The 
temperature-indicating device should be the reference instrument for 
determining conformance to the established process temperatures.
    3. Records. Monitoring records made by the processor should 
record the actual values that are occurring for those key aspect of 
the process identified by the process authority in section 4.b.1.ii 
of this Appendix.

5. Container Integrity Critical Controls Points

a. Finished Product Container Sealing

    Finished product containers must be inspected, and the results 
recorded, for container integrity to assure a consistently reliable 
hermetic seal. FDA recommends that:
    1. Visual seam inspection of one container from each seaming 
head occur every 30 minutes; and
    2. Testing by qualified personnel of one container from each 
seaming head occur at least every 4 hours. As applicable, these 
tests should be performed in accordance with 21 CFR 113.60(a)(1) and 
(a)(2).

b. Post-pasteurization Cooling

    Container cooling water must contain a measurable residual of 
chlorine or other sanitizer. Tests to determine the presence of a 
measurable residual of chlorine or other sanitizer in the container 
cooling water should be made, and the results recorded, at 
sufficient frequency to ensure control.

6. Time and Temperature Critical Control Points

a. Cooling After Cooking

    After cooking, the product must be rapidly cooled to minimize 
recontamination. Continuous cooling from 140  deg.F (60  deg.C) to 
achieve an internal temperature of 70  deg.F (21.1  deg.C) or below 
within 2 hours and an internal temperature of 40  deg.F (4.4  deg.C) 
or below within an additional 4 hours, unless processing after 
cooking, as described in section 6.b. of this Appendix, occurs 
during either of these time periods, will effectively minimize 
recontamination. Other time/temperature parameters may also be 
effective. Processors should ensure that the cooling parameters are 
met by either:
    1. Monitoring. Monitoring and recording internal product 
temperatures at least every 2 hours; or
    2. Studies.
    i. Conducting or obtaining a study that establishes that 
appropriate cooling temperatures are always met under prescribed 
processing conditions. The study should establish the limits of 
significant variables that could affect the rate of cooling. These 
variables may include product size, ambient air temperature, and 
amount of product in the cooler. An adequate study should consist of 
at least three processing runs under the prescribed processing 
conditions; and
    ii. Monitoring and recording the prescribed processing 
conditions as identified by the study in section 6.a.2.i. of this 
Appendix at least every 2 hours.

b. Processing After Cooking

    Products that will receive processing after cooking should not 
be exposed to ambient temperatures of 40  deg.F (4.4  deg.C) or 
higher for longer than a cumulative total of 4 hours after cooking. 
If they are exposed to such temperatures for more than 4 hours, 
unacceptable recontamination is the likely result. Processors are 
required to regularly monitor and record the length of time that the 
product is exposed to temperatures above 40  deg.F (4.4  deg.C) 
under 21 CFR 123.8. FDA recommends that such monitoring and 
recording be done at least every 2 hours.

c. Final Product Cooling

    To avoid microbiological hazards for perishable finished 
products, the internal temperature of the finished product should be 
40  deg.F (4.4  deg.C) or below within 4 hours of either placement 
in a finished product container or the completion of pasteurization. 
Processors should either conduct:
    1. Monitoring. Monitor and record internal product temperatures 
at least every 2 hours; or
    2. Studies.
    i. Conduct or obtain a study that establishes that the internal 
temperature of the finished product will always be 40  deg.F (4.4 
deg.C) or below within 4 hours of either placement in a finished 
product container or completion of pasteurization under prescribed 
processing conditions. The study should establish the limits of 
significant variables that could affect the rate of cooling. These 
variables may include product size, ambient air temperature, and 
amount of product in the cooler. An adequate study should consist of 
at least three processing runs under the prescribed processing 
conditions; and
    ii. Monitoring and recording the prescribed processing 
conditions as identified by the study in section 6.c.2.i. of this 
Appendix at least every 2 hours.

d. Refrigerated Storage

    1. In-process products. Refrigeration units that are being used 
to store in-process products or finished products shall operate at a 
temperature of 40  deg.F (4.4  deg.C) or below in accordance with 21 
CFR 123.10(a)(14).
    2. Temperature devices. Units should be equipped with both a 
temperature-indicating device and a temperature-recording device. In 
lieu of a temperature-recording device, a processor may equip a 
refrigeration unit with a high temperature alarm or a maximum-
indicating thermometer and maintain a temperature log that notes 
temperature with such frequency as is necessary to achieve control.

e. Distribution

    All perishable finished products should be distributed in a 
manner that ensures that the internal temperature is maintained at 
40  deg.F (4.4  deg.C) or below.

7. Temperature Monitoring Equipment

    Where reference is made in this Appendix to temperature-
indicating devices and temperature-recording devices, the following 
conditions should apply:

a. Temperature-Indicating Devices

    Temperature-indicating devices should be installed where they 
can be easily read and located to ensure that they accurately 
measure the warmest temperature of the refrigeration equipment and 
the coldest temperature of the heating equipment, as appropriate. 
Temperature-indicating devices should be calibrated at the routine 
operating temperature of the refrigeration, cooling, or heating 
equipment against a known accurate standard thermometer upon 
installation and at least once a year thereafter, or more 
frequently, if necessary, to ensure their accuracy. Records required 
to be maintained under 21 CFR 123.8 of accuracy checks for 
temperature-indicating devices should specify the date, standard 
used, method used, results, and person performing the test. A 
temperature-indicating device that has a divided fluid column or 
that cannot be adjusted to the standard should be immediately 
repaired or replaced.

b. Temperature-Recording Devices

    Temperature-recording devices should be installed where they can 
be easily read and the sensors for such devices should be installed 
to ensure that they accurately measure the warmest temperature of 
the refrigeration equipment and the coldest temperature of the 
heating equipment, as appropriate. Computerized storage of 
temperature data may be used in place of recorder thermometer charts 
if the use of such a system has been validated and can be shown to 
be substantially equivalent to the use of a temperature-recording 
device. Each temperature-recording device should be checked for 
accuracy at the beginning and end of each production day and 
adjusted as necessary to agree as nearly as possible with the 
reference temperature-indicating device. A record of these accuracy 
checks should be maintained that specifies the time, date, 
temperatures indicated by both devices before adjustment, corrective 
action taken, where applicable, and person performing the accuracy 
check.

8. Corrective Actions

    Under 21 CFR 123.7, whenever a deviation occurs at a critical 
control point, the processor shall segregate and hold the product 
until a review can be made to determine the effect of that 
deviation, and shall take corrective action as necessary. For 
cooked, ready-to-eat products, when a deviation occurs at a cooking 
or pasteurization critical control point, the processor should meet 
the requirements of Sec. 123.7 either by destroying the product; by 
fully reprocessing, where possible, that portion of the production 
involved, keeping full records of the reprocessing conditions; or by 
setting aside that portion of the product involved for further 
evaluation as to any potential public health significance. Such an 
evaluation should be made by a process authority and should be in 
accordance with procedures recognized by process authorities as 
being adequate to detect any unacceptable hazard to public health. 
Unless this evaluation demonstrates that the product had been given 
a thermal process that rendered it free of microorganisms of 
potential public health significance or, in the case of 
pasteurization, that resulted in the adequate reduction in numbers 
of microorganisms, the product set aside should be either fully 
reprocessed to correct the deficiency or destroyed. A record should 
be made of the evaluation procedures used and the results. Either 
upon completion of full reprocessing or after the determination that 
no significant public health hazard exists, that portion of the 
product involved may be shipped in normal distribution. Otherwise, 
the portion of the product involved should be destroyed.

9. Sanitary Zones

    In addition to the requirements of 21 CFR 123.10, sanitary zones 
should be established around areas in which cooked product is 
handled or stored. In such areas, objects and employees that have 
come into contact with waste, raw product, or other insanitary 
objects are excluded. Packaging material, equipment, employees, and 
in-process materials that enter a sanitary zone should be treated in 
a manner that will minimize the risk of the introduction of 
microorganisms. Air handling systems should be designed to minimize 
the risk of airborne contamination and to provide positive air 
pressure in the sanitary zone relative to the surrounding areas.

Appendix B to Part 123--Scombroid Toxin Forming Species

1. General guidelines for Scombroid Toxin Forming Species.
2. Critical control points.
3. Receipt of raw materials critical control point.
4. Processing critical control point.
5. Additional critical control points.

1. General Guidelines for Scombroid Toxin Forming Species

    This Appendix provides guidance on how to meet the requirements 
of 21 CFR part 123, subpart A for fish and fishery products that 
consist in whole or in part of scombroid toxin forming species. 
These include tuna, bluefish, mahi mahi, mackerel, sardines, 
herring, kahawai, anchovies, marlin, and other species, whether or 
not of the family Scombridae, in which significant levels of 
histamine may be produced in the fish flesh by decarboxylation of 
free histidine as a result of exposure of the fish after capture to 
temperatures that permit the growth of mesophilic bacteria. The 
guidance focuses on preventing the formation of scombrotoxin, which 
can be harmful to humans, as a consequence of improper handling 
after capture, i.e., time and temperature abuse.

2. Critical Control Points

    Every processor who engages in processing other than, or in 
addition to, storing of fish or fishery products that consist in 
whole or in part of scombroid forming species, must ensure that 
neither decomposition leading to histamine formation, nor histamine 
formation, has occurred before receipt of such fish or fishery 
products. Processors must also ensure that neither decomposition 
leading to histamine formation, nor histamine formation, occurs as a 
result of inadequate handling practices by the processor. In order 
to prevent these hazards from occurring, Hazard Analysis Critical 
Control Point (HACCP) plans prepared in accordance with 21 CFR part 
123, subpart A will typically identify and address the receipt of 
raw materials, as well as processing, as critical control points. In 
accordance with 21 CFR part 123, subpart A, processors shall 
identify in their HACCP plans how they will control hazards at 
critical control points. This appendix provides guidance on how to 
do so with respect to scombroid toxin forming species.

3. Receipt of Raw Materials Critical Control Point

a. First Processor

    1. On-board handling. The first processor to take ownership 
after harvest of fish and fishery products of scombroid toxin 
forming species should ensure that vessels supplying such fish have 
in place measures to ensure that the fish were rapidly brought to, 
and maintained at, an internal temperature of 40  deg.F (4.4  deg.C) 
or below, and were not held for a period of time sufficient to allow 
histamine formation to begin at the temperature at which they were 
held. The processor may determine the time and temperature history 
of the fish by requiring certification of the fishing method and on-
board handling practices, and a time/temperature log from the 
harvesting vessel. The time/temperature log should record, for each 
lot of fish, the date of harvest, fishing method, temperature of the 
harvest water, and temperature history of the fish relating to the 
lowering of the internal temperature. The temperature history of the 
fish may be documented by controlling and recording the key aspects 
of the cooling and storage operation (e.g., refrigerated brine or 
seawater temperature, fish size, and container packing). For 
purposes of this guideline, a lot of fish is the fish in a vessel 
storage compartment (i.e., well, tote, or other container). The log 
should be sufficient to enable the processor to determine whether 
the fish were subject to conditions in the water after capture, on 
the harvesting vessel, or in storage, that could cause, or 
significantly contribute to, the formation of histamine in the fish.
    2. Sampling and examination. The first processor, as described 
in section 3.a.1. of this Appendix, should subject a representative 
sample of fish in each lot from the vessel to an external 
organoleptic examination for decomposition and should record the 
results of the examination. A representative sample should provide 
at least 95 percent confidence that decomposition does not exist in 
more than 2.5 percent of the fish in the lot. If the number of fish 
from a vessel is small enough to permit an examination of each fish, 
e.g., because the weight of each fish is typically greater than 10 
pounds, the processor is encouraged to examine each fish.
    i. Any fish that exhibits decomposition should either be 
rejected and not used for food, or reconditioned according to the 
processor's established procedures. Reconditioning should include, 
at a minimum, removal of all parts of the fish that exhibit any 
decomposition, organoleptic reexamination of the remaining fish 
flesh, and the performance of a histamine analysis on the remaining 
fish flesh.
    ii. If no decomposition in any fish in a lot is detected through 
organoleptic examination, the following should apply:
    A. If the time/temperature log as described in section 3.a.1. of 
this Appendix indicates that the conditions on the vessel were 
unlikely to cause, or significantly contribute to, the formation of 
histamine in the fish, all the fish from that lot may be further 
processed or enter commerce.
    B. If the time/temperature log as described in section 3.a.1. of 
this Appendix indicates that the conditions on the vessel were 
likely to cause, or significantly contribute to, the formation of 
histamine in the fish in a lot, or if no adequate time/temperature 
log is available, a histamine analysis should be made on a 
representative sample of fish from that lot.
    iii. If decomposition is detected in less than 2.5 percent of 
the fish from a lot, the following should apply:
    A. If the time/temperature log as described in section 3.a.1. of 
this Appendix indicates that the conditions on the vessel were 
unlikely to cause, or significantly contribute to, the formation of 
histamine in the fish in a particular lot, those fish from that lot 
found to have decomposition should be treated in accordance with 
section 3.a.2.i. of this Appendix. Other fish from that lot may be 
further processed or enter commerce.
    B. If the time/temperature log as described in section 3.a.1. of 
this Appendix indicates that the conditions on the vessel were 
likely to cause, or significantly contribute to, the formation of 
histamine in the fish in a particular lot, or if no adequate time/
temperature log is available, the processor should perform a 
histamine analysis on a representative sample of organoleptically 
acceptable fish from that lot. (However, if the processor elects to 
perform a histamine analysis on a representative sample of each lot 
of fish from the vessel before conducting an organoleptic analysis 
for decomposition because, for example, the processor received the 
fish in a frozen state, the histamine analysis does not have to be 
repeated based on results of subsequent organoleptic analysis.)
    iv. If decomposition is detected in more than 2.5 percent of the 
fish from a particular lot, the processor should perform a histamine 
analysis on a representative sample of organoleptically acceptable 
fish from that lot.
    3. Histamine Findings.
    i. If any fish from a particular lot is found to have histamine 
above a defect action level or other regulatory level or limit for 
histamine established by FDA, the fish in that lot may not be used 
for food.
    ii. If any fish from a particular lot is found to have histamine 
below the defect action level or other regulatory level or limit for 
histamine established by FDA but above levels expected of fresh 
fish, the fish from that lot should enter commerce only if first 
immediately cooked to prevent histamine from increasing to 
unacceptable levels.

b. Subsequent Processors

    1. Processor evaluations. All subsequent processors who take 
ownership of fish and fish products of scombroid toxin forming 
species and who engage in processing other than, or in addition to, 
storage, should subject a representative sample each lot of such 
fish and fishery products to organoleptic evaluation for 
decomposition to determine whether decomposition occurred during 
transfer from the previous processor. Any fish that exhibits 
decomposition should be treated in accordance with section 3.a.2.i. 
of this Appendix.
    2. Decomposition. A finding of any organoleptically detectable 
decomposition should result in the organoleptic examination of the 
entire lot. If decomposition is detected in more than 2.5 percent of 
the fish in the lot, the processor should perform a histamine 
analysis on a representative sample of fish from the lot. The 
results should be treated in accordance with section 3.a.3. of this 
Appendix.
    4. Processing Critical Control Point.
    Products that are undergoing processing should not be exposed to 
ambient temperatures of 40  deg.F (4.4  deg.C) or higher for more 
than a cumulative total of 4 hours. Processors should ensure that 
this requirement is met by monitoring and recording, at least every 
2 hours, the length of time that the product is exposed to 
temperatures of 40  deg.F (4.4  deg.C) or higher.
    5. Additional Critical Control Points.
    The guidelines relating to cooked ready to eat fish and fishery 
products specified by Appendix A, sections 6 and 7 should also be 
applied to scombroid toxin forming species, where applicable.

Appendix C to Part 123--[Reserved]

Appendix D to Part 123--Product Integrity

    1. General guidelines for product integrity.
    2. Product integrity critical control points.

1. General Guidelines for Product Integrity

    This Appendix provides guidance on how a processor can use an 
HACCP-based approach to ensure that all fish and fishery products 
are in compliance with the economic adulteration and misbranding 
provisions of the Federal Food, Drug, and Cosmetic Act (sections 
402(b) and 403, respectively). This guidance applies to controlling 
economic factors including the identity of species, weight, count 
and size, and the percentage of valuable constituents. These factors 
must be accurately represented on the label and labeling of a food.

2. Product Integrity Critical Control Points

    Hazard Analysis Critical Control Point (HACCP) plans prepared in 
accordance with subpart A of 21 CFR part 123 will typically include 
the following critical control points, as appropriate, that can be 
used to ensure the economic integrity of the product:

a. Receipt of Raw Material

    A processor must ensure that the fish and fishery products that 
it receives are correctly identified as to species at the point of 
receipt into its processing facility. Methods used for 
identification upon receipt may include, but are not limited to:
    1. Exams. Physical examination of the seafood species by 
qualified personnel;
    2. Evaluations. Laboratory evaluation (e.g., protein 
chromatography); and
    3. Acceptance of species identity as certified by a supplier 
under either a Limited or a General and Continuing Guaranty, as 
provided for by section 303(c)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 CFR 7.12 and 7.13).

b. Labeling-Economic Value

    A processor must ensure that the finished product labels, 
labeling, and invoices accurately represent the weight, count, and 
size of the product, as well as the presence and amount of any 
valuable constituents. An example would be the handling of shrimp 
and breading material to make breaded shrimp. The processor must 
ensure that the shrimp has not been adulterated by the addition of 
water, and that the valuable constituents are present at levels that 
are consistent with FDA standards of identity (21 CFR part 161) and 
compliance policy guides. The processor thus should provide for 
monitoring of the level of the valuable constituents throughout 
receipt, processing, and distribution to ensure that:
    1. Identification. The species is correctly identified by its 
common or usual name and is so represented on the label and 
labeling. Guidance in selecting the correct common or usual name of 
a species is provided by the FDA Fish List. Specific requirements 
are given in 21 CFR 101.18 and 21 CFR part 161.
    2. Valuable constituents. The valuable constituents of the 
product are not omitted or abstracted from the product (e.g., 
breaded shrimp contains the required weight ratio of shrimp to 
breading and, if appropriate, shrimp of the size and weight 
specified on the label or labeling).
    3. Substitution. No substance is substituted wholly or in part 
for the valuable constituent (e.g., through added water or glazing, 
or substitution of crab flavored surimi for crab meat in a product 
labeled as crab cake).
    4. Damage or inferiority. Damage or inferiority is not concealed 
in any manner (e.g., through bleaching or coloring of product to 
conceal its true nature or condition of wholesomeness).
    5. Product adulteration. No substance is added to, or mixed 
with, the product to increase its bulk or weight or to reduce its 
quality, or make it appear of better or greater value than it is 
(e.g., through adding water to a product by chemical or other 
means).

PART 1240--CONTROL OF COMMUNICABLE DISEASES

    2. The authority citation for 21 CFR part 1240 continues to read as 
follows.

    Authority: Secs. 215, 311, 361, 368 of the Public Health Service 
Act (42 U.S.C. 216, 243, 264, 271).

    3. Section 1240.3 is amended by revising paragraph (p) to read as 
follows:


Sec. 1240.3  General definitions.

* * * * *
    (p) Molluscan shellfish. Any edible species of fresh or frozen 
oysters, clams, mussels, and scallops or edible portions thereof, 
except when the scallop or scallop product consists entirely of the 
shucked adductor muscle.
    4. Section 1240.60 is amended by revising the section heading; by 
designating the existing text as paragraph (a) and adding the word 
``molluscan'' before the word ``shellfish'' the two times that it 
appears; and by adding new paragraphs (b) and (c) to read as follows:


Sec. 1240.60  Molluscan shellfish.

* * * * *
    (b) All unshucked raw molluscan shellfish, that is all unshucked 
molluscan shellfish that has not been subject to a treatment sufficient 
to kill pathogens of public health significance, shall bear a tag that 
discloses the date and place they were harvested, type and quantity of 
shellfish, and by whom they were harvested, including the number 
assigned to the harvester by the shellfish control authority. Any raw 
molluscan shellfish that are found by FDA in interstate commerce 
without such a tag or label, or with a tag or label that does not bear 
all the required information, will be subject to seizure and 
destruction.
    (c) Shucked molluscan shellfish shall be subject to the same 
requirements as apply to molluscan shellfish that has not been shucked 
as provided in paragraph (b) of this section, except that, in lieu of a 
tag, the body of the container of shucked molluscan shellfish, shall 
bear a label that identifies the name, address, and certification 
number of the processor of the molluscan shellfish.

    Dated: January 21, 1994.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
    Note: The following appendix will not appear in the annual Code 
of Federal Regulations.

Appendix 1--FDA Fish Fishery Products Hazard and Controls Guide 
Including Guidance on Smoked Fish

    FDA is in the process of developing guidance to, among other 
things, assist the seafood industry develop and implement HACCP 
systems. The guidance will be titled the ``FDA Fish and Fishery 
Products Hazard and Controls Guide.'' When a draft of the entire 
Guide is completed in the near future, FDA will publish a notice of 
availability in the Federal Register and invite public comment. FDA 
will revise the draft as warranted and then issue the first edition 
of the Guide.

I. The Information Presented

    The selected portions of the draft Guide that are provided below 
are:
    Example 1. The Table of Contents.
    Example 2. One page each from the ``Vertebrate'' and 
``Invertebrate Hazard and Control Lists.'' Together, these lists 
contain about 350 species of commercially marketed fish. Each list 
is in the form of a chart that directs the reader to one or more of 
the 10 numbered hazard and control descriptions elsewhere in the 
Guide for species-related hazards. For purposes of the Guide, 
species-related hazards are those that can occur in the environment 
or during harvest. Processors should find in the appropriate list 
the species they handle, then turn to those numbered hazard and 
control descriptions that are relevant to that species.
    Example 3. A sample of a species-related hazard and control 
description (Species-related Hazard and Control #1 (Chemical 
Contamination)). Each description explains a hazard and the measures 
available to control it, with an emphasis on HACCP controls such as 
critical control points, critical limits, monitoring procedures and 
frequencies, recordkeeping, and corrective actions. Some 
descriptions contain several control options.
    Example 4. One page from the ``Process-related Hazards and 
Controls List.'' For purposes of this Guide, process-related hazards 
are those that can occur because of the nature of the processing 
procedures and the finished product form. This list includes 20 
types of finished products (e.g., cooked shrimp) and directs the 
reader to one or more of the 22 process-related hazard and control 
descriptions, which are located in the next part of the Guide.
    The process-related hazard and control descriptions are 
numbered. Some of them are further subdivided into lettered 
portions. Where the reader need only refer to a portion of a 
process-related hazard and control description, the list directs the 
reader to that portion by referring to a lettered part of the 
description. See below.
    Example 5. A sample of a process-related hazard and control 
description (``Process-related Hazard and Control #11'' (pathogen 
survival during pasteurization)). As with the species-related 
descriptions discussed above, each process-related description 
explains a hazard and the measures available to control it, with an 
emphasis on HACCP controls. Some of these descriptions are 
subdivided. For example, ``Process-related Hazard and Control No. 
8,'' which is about temperature abuse, is subdivided into ``8a: 
Histamine,'' ``8b: Pathogens,'' and ``8c: Decomposition.'' Where the 
list in 4. above directs a reader to a number-letter combination, 
e.g., ``8b,'' it is to one of the subdivided portions of a 
description, in this case to the ``Pathogens'' material in Process-
related Hazards and Controls #8.
    Example 6. A consolidated section for smoked and smoke-flavored 
fishery products.
    Example 7. A model HACCP plan. This is essentially a fill-in-
the-blank model. Processors can use the materials in the hazards and 
controls descriptions and this model plan, to develop much if not 
all of their HACCP plans, depending on their circumstances.
    It must be remembered that these materials reflect a work in 
progress and are published to provide the public with a preview of 
the document. When the entire document is made available to the 
public in the near future, the selected portions published here may 
have been revised.
    To help processors and other interested persons to understand 
the guidance presented in the consolidated section on smoked fishery 
products, FDA will explain that guidance in the section that 
follows.

II. Smoked Fishery Products

    Research conducted since FDA proposed the 1970 final rule shows 
that less stringent processing temperatures and lower water-phase 
salt content, with or without use of other inhibiting factors such 
as sodium nitrite, can provide an adequate margin of safety for hot-
process products held in refrigerated storage (40  deg.F (4.4 
deg.C) or lower). FDA has considered this research, and based on it, 
the agency is proposing a guidance setting forth what it tentatively 
finds are the minimum time, temperature, and salinity requirements 
to make a safe and marketable smoked fish product. Proposed TTS 
parameters are found in example 6 of this appendix.
    A. Raw Materials/Handling of Unprocessed Fish.
    The presence of microorganisms, including C. botulinum and L. 
monocytogenes, cannot be avoided in fresh-water fish and marine fish 
because they are present in the aquatic environment. Under certain 
conditions, the potential exists for the outgrowth of C. botulinum 
spores and toxin production (Refs. 148 through 152), as well as for 
an increase in the L. monocytogenes population (Ref. 143).
    To minimize microbial growth, fresh fish should be maintained at 
refrigerated temperatures close to 38  deg.F (3.3  deg.C) (Refs. 173 
and 175). Although certain strains of C. botulinum are capable of 
growth at temperatures as low as 38  deg.F (3.3  deg.C), favorable 
growth media are necessary for a significant growth rate to occur at 
this temperature. For example, it has been shown that C. botulinum 
Type E requires 31 to 35 days before outgrowth and toxin production 
occurs in a beef stew media held at 38  deg.F. However, outgrowth 
and toxin production in a cooked meat medium held at 41  deg.F does 
not occur until after 56 days, demonstrating that less favorable 
growth media can significantly lower the rate of growth. Even in 
those cases where C. botulinum does grow and produce toxin, the 
laboratory conditions are generally more ideally suited to growth 
than those found in nonexperimental situations where less favorable 
growth environments prevail. Thus, while the growth of C. botulinum 
is not completely inhibited at 40  deg.F (4.4  deg.C), under the 
less than ideal conditions for its growth that are generally 
encountered in the processing of smoked fish, FDA has tentatively 
concluded that maintaining fresh fish at a maximum temperature of 40 
 deg.F, only 2 degrees above the temperature of complete growth 
inhibition, before and during processing will provide adequate 
protection against C. botulinum outgrowth. Moreover, 40  deg.F (4.4 
deg.C) is consistent with the maximum temperature FDA has proposed 
in various guidelines, such as the Unicode (now called the Food 
Code) (53 FR 16472, May 9, 1988). Therefore, under proposed 
Sec. 123.10(a)(14), all raw fish that is to be smoked must be 
refrigerated until needed for processing (Ref. 175).
    Similarly, fish that are initially frozen need to remain in the 
frozen state until needed for processing (Refs. 161 and 25). When 
frozen fish are needed for processing, the thawing procedure must be 
carried out in a way that minimizes the opportunity for microbial 
growth (Refs. 161 and 171). The method used to thaw the fish must 
provide an environment that will inhibit the growth of C. botulinum 
and other microorganisms that pose a potential health hazard (Refs. 
171 and 172). Thus, the fish should be thawed in a way that ensures 
that the internal temperature at the core of the fish does not 
exceed 40  deg.F (4.4  deg.C) (Refs. 171 and 172). Therefore, 
section 4.a. of Example 6 of this appendix, the agency suggests that 
this procedure be used in the thawing process.

B. Manufacturing Operations

    Reduction of the potential health hazard from C. botulinum spore 
outgrowth and toxin production in smoked and smoke-flavored fish 
relies on the interrelationship of processing time, processing 
temperature, water-phase salt concentration in the loin muscle, and 
smoke (or constituents of smoke) deposition, combined with 
refrigerated storage (40  deg.F (4.4  deg.C) or lower) (see proposed 
Sec. 123.10(a)(14)) (Ref. 173). At one time, smoking and associated 
brining may have been an effective preservation method. With the 
changes in processing techniques that have occurred since the advent 
of refrigeration and in response to consumers' demands for products 
with certain organoleptic qualities, however, smoked fish products, 
either hot- or cold-process, have become perishable products that 
must be refrigerated and cannot be considered preserved foods (Ref. 
173). The changes that have occurred, both in processing techniques 
and in organoleptic qualities, have resulted in products that are 
more moist and contain less salt. As a result, the two critical 
processing factors that affect the overall preservation and safety 
of the product have been altered. The processing time-temperature 
parameters have been decreased, and the water-phase salt content has 
been reduced (Ref. 173). Therefore, these products need to be 
maintained at refrigerated temperatures (40  deg.F (4.4  deg.C) or 
lower) or frozen immediately after processing to ensure the overall 
quality of these products (Ref. 173).
    1. Brining/dry salting. Salt, as a preservative in smoked and 
smoke-flavored fish, is somewhat limited in its effectiveness 
because of the variability in salt uptake by fish flesh, even among 
fish in the same brining tank. Ventral muscle, which is thin, 
absorbs high levels of salt, while the thicker dorsal muscles absorb 
less salt, limiting the effectiveness of salt as a deterrent against 
spore outgrowth in that part of the fish. Equilibration techniques, 
such as two-stage brining, reduce variation in salt content within a 
fish and increase the preservative effect (Ref. 176).
    It is possible that salt-tolerant microorganisms of public 
health concern (such as strains of Staphylococcus) may grow during 
brining or after the dry salting process. Therefore, FDA is 
providing in section 5.c. and 5.e. in example 6 of this appendix 
that the brining and dry salting of fish be carried out at 
refrigerated temperatures, i.e., 40  deg.F (4.4  deg.C) or lower. 
Doing so will ensure that the environment in which brining is done, 
and in which fish are held after dry-salting, will inhibit the 
growth of salt-tolerant microorganisms that can cause a potential 
health hazard (Ref. 173).
    FDA recognizes that when fish are initially added to the brine, 
the temperature of the brine may increase. It is essential to this 
process that the brine be returned to refrigerated temperatures 40 
deg.F (4.4  deg.C) or lower to reduce the opportunity of microbial 
growth and to ensure the overall quality of the product during the 
brining process (Refs. 175 and 182). Therefore, the agency is 
suggesting in section 5.d. of Example 6 of this appendix that the 
temperature of the brine not exceed 60  deg.F (16  deg.C) at the 
start of brining.
    To minimize the variation in salt content of the fish, the 
agency is recommending in section 5.f. of Example 6 of this appendix 
that only fish of the same species and of similar size and similar 
weight be brined in the same tank (Refs. 171 and 199). Because reuse 
of brine solutions is a possible route of microbial contamination of 
raw fish, the agency is providing in section 5.g. of Example 6 of 
this appendix that brines not be reused unless they have been 
processed in some way to return them to a microbiological quality 
equivalent to the original, unused brine made with potable water and 
food-grade salt. The agency is also providing in section 5.h. of 
Example 6 of this appendix that a processor may rinse the brined 
fish with fresh water to remove any unwanted excess salt on the 
exterior of the fish.
    2. Drying. Fish that are to be processed as smoked or smoke-
flavored fish are dried after brining to remove excess water and 
prevent dripping during smoking. The drying process, usually of 
several hours in duration, provides another opportunity for 
microbial growth. Therefore, to minimize the opportunity for 
microbial growth by reducing those conditions that would provide a 
favorable environment for such growth, the agency is providing in 
section 5.i. of Example 6 of this appendix that the presmoking 
drying step should be conducted in a refrigerated room (Ref. 46).
    3. Smoking. Smoke deposition, like water-phase salt content, is 
very difficult to control. Constituents of smoke called ``inhibitory 
compounds'' (such as phenolic compounds) are reported to have a 
bactericidal effect (Ref. 177). Factors that affect the quantity of 
inhibitory compounds deposited on the fish surface and the degree of 
penetration by those compounds into the fish are the humidity in the 
smoking chamber, the temperature of smoking, and the air flow in the 
smoking chamber (Ref. 178). Decreased levels of inhibitory compounds 
reduce the preservative effect of the smoke and make dependence on 
these compounds inadvisable (Ref. 178). In general, smoked products 
are not shelf stable and must be either refrigerated at a 
temperature of 40  deg.F (4.4  deg.C) or lower or frozen immediately 
after processing (Refs. 43, 45, and 178).
    To promote uniform deposition of smoke, heat exposure, and 
dehydration, and to ensure that on completion of these processes, 
the fish do not contain any raw or wet sections that would create an 
environment favorable for microbial growth and spoilage, the agency 
is providing in section 5.j. of Example 6 of this appendix that fish 
should be arranged in the smokehouse chamber or oven so that they 
are not overcrowded or touching each other, and that only fish of 
like size and weight should be included in a single batch of fish 
for smoking.
    Liquid smoke, a solution of wood smoke that, when diluted, may 
be used to impart a smoke flavor to fish products, is often used as 
an alternative to generated smoke. Liquid smoke has been reported to 
have similar antibacterial properties to, and some advantages over, 
generated smoke (Ref. 26). It is easier to apply uniformly, and the 
inhibitory compounds penetrate further into the fish flesh (Ref. 
26). Liquid smoke, generated smoke, or a combination of liquid smoke 
and generated smoke needs to be applied to all surfaces of fish to 
be smoked. Liquid smoke may be applied to the product before, at the 
commencement of, or during the process, while generated smoke needs 
to be applied to the fish during the first half of the process and 
longer if necessary (Refs. 178 and 179). If a combination of liquid 
smoke and generated smoke is used, the method for use of liquid 
smoke may be followed, and the generated smoke may be applied at any 
stage of the process (Ref. 26). The agency is providing for the use 
of liquid smoke alone or in combination with generated smoke in 
section 3.c.2. of Example 6 of this appendix to impart smoke flavor 
and antibacterial properties to the products.
    4. Use of sodium nitrite. Use of sodium nitrite in smoked and 
smoke-flavored fish products is limited to the species listed in 
Sec. 172.175 (21 CFR 172.175) and to chubs in Sec. 172.177 (21 CFR 
172.177). Section 172.175 permits the use of sodium nitrite as a 
preservative and color fixative in cured, smoked sablefish, salmon, 
and shad. However, it requires that the level of sodium nitrite in 
the final product not exceed 200 ppm. Use of sodium nitrite 
substantially reduces the level of salt necessary to inhibit 
outgrowth of C. botulinum type A and type E spores, although the 
levels vary because of the difference in heat resistance between the 
two types of spores (Ref. 179). The quantity of sodium nitrite 
necessary to achieve inhibition is affected by both the level of 
contamination and the resistance of the spores (Refs. 179 and 180). 
Refrigeration of the finished product at temperatures of 40  deg.F 
(4.4  deg.C) or below is necessary to retain the inhibitory 
characteristic gained through use of sodium nitrite (Ref. 179). 
Therefore, in accordance with the provisions of Secs. 172.175 and 
172.177, the agency is proposing to provide for the use of sodium 
nitrite in the processing and packaging of smoked and smoke-flavored 
fish in section 5.a. and section 5.b. of Example 6 of this appendix.
    5. Vacuum- and modified atmosphere-packaging. Vacuum packaging 
and other types of modified atmosphere-packaging (those in which the 
air in the package or container is replaced by one or more gases, in 
various concentrations, before the package is sealed) extend the 
shelf life of foods markedly. However, the anaerobic environment 
created in these types of packaging favors the outgrowth of C. 
botulinum spores and subsequent toxin production, and it inhibits 
growth of aerobic microorganisms that might otherwise serve as 
organoleptic indicators of spoilage (Refs. 180 and 182). 
Consequently, use of vacuum- or modified atmosphere-packaging 
demands strict adherence to temperature-controlled storage and 
distribution to reduce the opportunity for spore outgrowth and toxin 
production and to reduce the potential growth of other 
microorganisms of public health significance (such as L. 
monocytogenes).
    Two methods of reducing the potential public health hazard of 
vacuum or modified atmosphere packaged smoked, smoke-flavored, and 
salted fish products are: (1) To store and distribute the products 
frozen or, alternatively, (2) to use in-package heat processing 
followed by refrigeration. At freezer temperatures, outgrowth of 
spores of C. botulinum types B, E, and F is retarded (Refs. 171, 
173, and 180). Type A does not grow below 50  deg.F (10  deg.C) 
(Refs. 179 and 180). Storage and distribution in the frozen state 
reduces the possibility that temperature abuse will occur.
    In-package heat processing, sometimes referred to as ``heat 
pasteurization,'' at temperatures in the range of 185  deg.F (85 
deg.C) for 85 minutes to 198  deg.F (92  deg.C) for 55 minutes, 
inhibits outgrowth and toxin production by type E spores (Ref. 185). 
Longer exposure to processing temperatures is required for more heat 
resistant spores, such as types B and A (Ref. 185). In a study 
examining this method of packaging, samples of hot-process salmon 
steaks were injected with spores of nonproteolytic strains of C. 
botulinum types B and E (Ref. 185). The steaks were vacuum packaged, 
heat pasteurized, then incubated using different time-temperature 
combinations. The results of this research showed that closely 
controlled in-package heat processing extends the shelf life of the 
product, inactivates nonproteolytic C. botulinum types B, E, and F 
and other vegetative pathogens, and maintains product quality 
attributes. However, this process is more suitable for pieces, 
fillets, and steaks than for whole eviscerated fish because this 
process causes the flesh to separate from the backbone (Ref. 185).

C. Specific Processing Conditions

    The various processing techniques used to produce smoked and 
smoke-flavored fish are affected by the interrelationship of the 
smoking, the method of smoke application, the time-temperature 
combinations used, and the water-phase salt content. A critical 
factor in determining alternative processing methods is the type of 
packaging utilized, specifically whether the product is air-packaged 
or vacuum-packaged. The following discussion sets out the various 
processing procedures that the agency has tentatively concluded will 
ensure the safety of hot-process smoked and smoke-flavored fish, and 
cold-process smoked and smoke-flavored fish.
    1. Hot-process smoked and smoke-flavored fish. a. Air-packaged. 
Research data and industry practice show that a lower minimum water-
phase salt content (3.5 percent or lower), in combination with lower 
processing temperatures (lower than 180  deg.F (82  deg.C)) than 
cited in the 1970 final rule for hot-process products are effective 
in inhibiting spore outgrowth and toxin production when the products 
are not vacuum-packaged and are held at refrigerated temperatures 
(40  deg.F (4.4  deg.C) or lower) (Refs. 24, 163, and 177). Research 
studies from the National Marine Fisheries Service and testimony 
presented at a public hearing held by the New York State Department 
of Agriculture and Markets on May 3, 1989, to establish a CGMP for 
the manufacture of smoked and smoke-flavored fish products, show 
that C. botulinum type E is inhibited in air-packaged smoked fish 
products when the water-phase salt content is at least 3.0 percent, 
and the processing internal temperature of the product is maintained 
at a minimum of 145  deg.F (63  deg.C) for at least 30 minutes (Ref. 
180). In light of these findings, FDA is setting forth these 
processing parameters in Example 6 of this appendix to provide 
guidance on the safe manufacturing of these products.
    The agency is setting forth the following minimum T-T-S 
parameters for air-packed, hot-process smoked and smoke-flavored 
fish in section 5.a.1. of Example 6 of this appendix: Heating at an 
internal temperature of 145  deg.F (63  deg.C) for 30 minutes with a 
water-phase salt content of 3.0 percent in the finished product.
    b. Vacuum-packaged/modified atmosphere. For vacuum-packaged 
products, National Marine Fisheries Service research shows that 
processing temperatures in the range of 145 to 175 deg. F (63 to 80 
deg.C) for hot-process smoked fish will inhibit C. botulinum type E 
when the water-phase salt content is greater than 3.5 percent (Refs. 
26, 173, and 180). Based on this evidence, New York's CGMP included 
a procedure for processing vacuum-packaged smoked fish that 
specifies heating the fish to an internal temperature of 145  deg.F 
(63  deg.C) for 30 minutes, with a water-phase salt content of 3.5 
percent (Ref. 25).
    The use of sodium nitrite in combination with sodium chloride 
significantly inhibits the outgrowth and toxin production of C. 
botulinum type E. Research data show that when the water-phase salt 
content and sodium nitrite content are at least 3.1 percent and 100 
ppm, respectively, and the internal temperature of the fish is not 
less than 145  deg.F, the inhibitory effect on C. botulinum growth 
and toxin production greatly increases (Refs. 173 and 179). At 
higher processing temperatures, e.g., 180  deg.F (82  deg.C), a 
water-phase salt content of 3.0 percent or more inhibits toxin 
formation by C. botulinum type E (Ref. 163).
    Based on this information, the agency is setting forth the 
following T-T-S parameters for vacuum-packaged hot-process smoked 
and smoke-flavored fish in section 5.a.2. of Example 6 of this 
appendix: (1) Heating at an internal temperature of at least 145 
deg.F (63  deg.C) for 30 minutes with a minimum water-phase salt 
content of 3.5 percent in the finished product, or (2) heating at an 
internal temperature of at least 145  deg.F (63  deg.C) for 30 
minutes, with a minimum water-phase salt content of 3.0 percent, and 
a sodium nitrite content of 100 to 200 ppm (as permitted by the food 
additive regulations in Sec. 172.175) in the finished product, or 
(3) as described in Sec. 172.177 for smoked chub containing sodium 
nitrite.
    The agency points out that these processing parameters for 
vacuum-packaged hot-process smoked and smoke-flavored fish are 
minimums. Unless the comments on Example 6 of this appendix convince 
the agency otherwise, fish that have been processed at a lower 
temperature or with a lower water-phase salt level could provide the 
basis for regulatory action on the grounds that the product has been 
processed under conditions whereby it may have been reduced 
injurious to health and thus could represent a hazard for consumers.
    2. Cold-process smoked and smoke-flavored fish. Cold-process 
smoked and smoke-flavored fish, by virtue of the temperatures used 
in processing, are not cooked because they are processed at 
temperatures lower than those that coagulate protein, i.e., 100 
deg.F (38  deg.C) or lower. Because these temperatures are not high 
enough to inactivate C. botulinum spores, and because they provide a 
favorable environment for other food spoilage microorganisms, other 
inhibitive factors, such as higher salt content and sodium nitrite 
(where permitted by food additive regulations in Sec. 172.175) need 
to be used.
    The time and temperature relationship in the processing of cold-
smoked and smoke-flavored fish is a critical factor in yielding a 
microbiologically safe and high quality finished product (Ref. 182). 
Modern establishments that cold-smoked fish generally process 
between 40  deg.F (5  deg.C) and 100  deg.F (38  deg.C) for 18 to 24 
hours (Refs. 171 and 182). Based on the research data that are 
available and the requirements in the New York CGMP, the agency is 
proposing the following requirements for air-packaged and vacuum-
packaged/modified atmosphere cold-process smoked and smoke-flavored 
fish (Refs. 25, 180, and 184).
    a. Air-packaged products. The agency is providing in section 
5.a.3. of Example 6 of this appendix that air-packed, cold-process 
smoked and smoke-flavored fish should have a minimum water-phase 
salt content of: (1) 3.5 percent, or (2) 3.0 percent and contain 100 
to 200 ppm of sodium nitrite in the finished product, or (3) 2.5 
percent in the finished product if the product is frozen immediately 
after processing and cooling and is kept frozen throughout holding 
and distribution. The agency is providing that the finished product 
that contains a water-phase salt content of 2.5 percent should be 
frozen immediately and kept frozen to ensure the microbiological 
safety of the product, as well as to maintain the shelf-life of the 
finished product.
    As stated above, because these products are not cooked and 
contain a low water-phase salt content, these products may present a 
potential public health hazard because they provide an ideal 
environment for the outgrowth of C. botulinum spores and toxin 
production. Therefore, based on the discussion above, the agency is 
suggesting that air-packaged cold-process smoked and smoke-flavored 
fish be processed under one of the following sets of conditions: (1) 
A maximum 20-hour drying and smoking period with the temperature in 
the smoking chamber not exceeding 90  deg.F (32  deg.C) (section 
5.a.3.i. of Example 6 of this appendix), or (2) a maximum 24-hour 
drying and smoking period with the temperature in the smoking 
chamber not exceeding 50  deg.F (10  deg.C) (section 5.a.3.ii. of 
Example 6 of this appendix) except that sablefish needs to be heated 
to a temperature not to exceed 120  deg.F (49  deg.C) for a period 
not to exceed 6 hours (section 5.a.3.iii. of example 6 of this 
appendix) (Refs. 25, 180, and 184).
    b. Vacuum-/modified atmosphere-packaged products. FDA is 
providing in section 5.a.4. of Example 6 of this appendix that cold-
process smoked and smoke-flavored fish to be vacuum- or modified 
atmosphere-packaged should have a minimum water-phase salt content 
of: (1) 3.0 percent and contain 100 to 200 ppm of sodium nitrite in 
the finished product, or (2) 3.5 percent in the finished product 
when no sodium nitrite is used. The agency is also providing that 
vacuum-/modified atmosphere-packaged cold-process smoked and smoke-
flavored fish should be processed under one of the following sets of 
conditions: (1) A maximum 20-hour drying and smoking period with the 
temperature in the smoking chamber not exceeding 90  deg.F (32 
deg.C) (section 5.a.3.i. of Example 6 of this appendix), or (2) a 
maximum 24-hour drying and smoking period with the temperature in 
the smoking chamber not exceeding 50  deg.F (10  deg.C) (section 
5.a.3.ii. of Example 6 of this appendix) (Refs. 25, 180, and 184).
    The agency again points out that these processing parameters for 
vacuum-/modified atmosphere-packaged cold-process smoked and smoke-
flavored fish are minimums. Failure to adhere to these parameters 
could provide the basis for regulatory action because the product 
that results may be injurious to health and thus could represent a 
hazard to consumers.
    The agency believes that the proposed processing requirements 
for cold-process smoked and smoke-flavored products, air-packed and 
vacuum- or modified atmosphere-packaged, will produce a safe and 
commercially acceptable product. However, because less data and 
information are available for these products than for hot-process 
products, the agency is requesting specific comments, data, and 
information about these processing parameters and any alternative 
processing parameters that should be included in the guideline.
    3. Cooling and storage of finished products. Rapid cooling and 
storage at temperatures of 40  deg.F (4.4  deg.C) or below are 
essential for all smoked, smoke-flavored, and salted fish products 
to minimize microbial growth. The exceptions are cold-process air-
packaged products that contain a water-phase salt content of 2.5 
percent, which should be frozen immediately after processing and 
remain frozen throughout distribution because of the lower water-
phase salt content and lower processing temperatures that may 
provide an opportunity for food spoilage microorganisms to flourish 
during storage (see section 5.a.3. of Example 6 of this appendix) 
and the discussion above).
    Outgrowth of C. botulinum spores, types A and proteolytic B, and 
toxin production are inhibited at temperatures of 50  deg.F (10 
deg.C) and lower. Spore types E and nonproteolytic B are completely 
inhibited at temperatures of 38  deg.F (3.3  deg.C) and lower (Refs. 
174 and 185 through 188).
    At section 6 of Example 6 of the appendix, the agency is 
recommending specific time/temperature controls for processing after 
smoking. These proposed controls are the same as those proposed for 
after cooking in the cooked, ready-to-eat section of this document 
(Appendix A, section 6). A full discussion of the controls is 
provided in section VII.J.3. of this document.
    4. Alternative processing parameters. As this preamble 
indicates, FDA has tentatively concluded that the TTS processing 
parameters reflected in this appendix are the minimum necessary to 
ensure that these products are free from botulinum toxin over their 
shelf life. FDA has also tentatively concluded that the T-T-S 
parameters, coupled with good sanitation practices, will also render 
these products listeria free. Nonetheless, the agency does not wish 
to discourage the development and use of alternative procedures that 
are capable of achieving the same outcome.
    Consequently, section 11 of Example 6 of this appendix calls for 
the use of alternative processing parameters when the user can 
demonstrate the following: (1) For botulism, zero toxin production 
slightly beyond the expected shelf life of the product, demonstrated 
through inoculated pack studies under normal and moderate abuse 
conditions and (2) for listeria, no detectable L. monocytogenes in 
the final product. The data demonstrating these outcomes would have 
to be available to FDA to enable the agency to determine whether 
they have been achieved.
    Example 6 of this appendix states that those data should be part 
of a processor's HACCP records. FDA asks for comment on whether a 
third-party scientific expert, or processing authority, should be 
involved in the development of the data that demonstrate the 
effectiveness of the alternative procedure.
    5. Use of vacuum- and modified atmosphere-packaging. As 
explained above, vacuum- or modified atmosphere-packaged smoked, 
smoke-flavored, and salted fish products represent an increased 
public health hazard over conventionally packaged products because 
these types of packaging provide the ideal environment for spore 
outgrowth and toxin production. Based on the discussion above, the 
agency states in section 3 of Example 6 of this appendix that these 
types of packaging should be used only when: (1) As provided in 
section 5.a.2. of Example 6 of this appendix the product is a hot-
process smoked or smoke-flavored product, is vacuum-packed or 
modified atmosphere-packed, and contains at least 3.5 percent water-
phase salt in the finished product, or 3.0 percent salt and 100 to 
200 ppm of sodium nitrite in the finished product (section 4.a.1. of 
Example 6 of this appendix); (2) as provided in section 5.a.4. of 
Example 6 of this appendix, the product is a cold-process smoked or 
smoke-flavored product, is vacuum-packed or modified atmosphere- 
packed, and contains at least 3.5 percent water-phase salt in the 
finished product or 3.0 percent salt and 100 to 200 ppm of sodium 
nitrite.
    The agency is providing in Appendix C, section 8.a. that all 
vacuum- or modified atmosphere-packaging should be conducted within 
the processing plant where the product is manufactured (Ref. 180). 
FDA considers this limitation appropriate to prevent any 
postprocessing contamination of the product from bacterial pathogens 
and to ensure that the fish will be packaged immediately after 
processing to protect its overall quality.
    6. Process monitoring. Section 7 of Example 6 of this appendix, 
the agency is recommending specifications for temperature indicating 
and recording devices where they are recommended elsewhere in this 
appendix. These proposed specifications are the same as those 
proposed in Appendix A for cooked, ready-to-eat fishery products 
(Appendix A, section 7). A full discussion of these controls is 
provided in section VII.J.4. of the preamble to this document. 
Temperature indicating and recording devices are specifically 
recommended in section 5.j. and 5.k. of Example 6 of this appendix 
for the control of the smoking temperature.
    At section 5.b. of Example 6 of this appendix, the agency is 
recommending specific controls to ensure that the appropriate water-
phase salt and sodium nitrate levels are achieved. The significance 
of these attributes has already been discussed in this document. In 
section 5.b. of Example 6 of this appendix, the agency recommends 
that a processor perform or obtain a study that shows that under 
certain processing conditions the desired water phase salt or sodium 
nitrite level will reliably be achieved. The processor should 
monitor those processing conditions identified by the study as 
having an impact on the ability of the product to achieve the 
desired level. The study should provide critical limits for each of 
the relevant processing conditions (e.g. maximum fish size, minimum 
soak time, minimum salt to product ratio).
    Because of the existence of numerous variables that affect the 
ability of fish to uniformly take up salt and sodium nitrite, it may 
be appropriate for a processor to perform periodic finished product 
water phase salt or sodium nitrite analyses as a verification step. 
The purpose of such analyses would be to identify any variables that 
have an impact on salt or nitrite absorption that were not 
identified by the study.
    7. Corrective actions. At section 9 of Example 6 of this 
appendix, the agency is recommending corrective action procedures. 
These proposed procedures are the same as those proposed in the 
cooked, ready-to-eat section of this document (Appendix A, section 
8). A full discussion of the procedures is provided in section 
VII.J.5 of the preamble to this document.
    8. Sanitary zones. At section 10 of Example 6 of this appendix, 
the agency is recommending the institution of sanitary zones. This 
proposed control procedure is the same as that proposed in the 
cooked, ready-to-eat section of this document (Appendix A, section 
9). A full discussion of the control procedure is provided in 
section VII.J.6 of the preamble to this document.
    To further ensure the safety of the product during distribution 
and storage, FDA is considering adopting specific package labeling 
requirements for smoked and smoke-flavored fish products to reduce 
the opportunity of temperature abuse of the finished product. The 
agency requests comments on whether it should require that the label 
of all shipping containers and retail packages state that the 
product is perishable, and, more specifically, that the product must 
be kept refrigerated. FDA tentatively finds that such labeling is 
extremely important to ensuring the safe handling of these products, 
and, therefore, it considers it likely that it will require this 
labeling in the final rule. The agency requests comment on whether 
it should do so. The agency also requests comment on whether, if it 
decides to require such a label statement, the statement should 
specify a temperature at which the product should be refrigerated 
(e.g. 40  deg.F (4.4  deg.C) or below). The agency is also 
considering requiring that the label of all frozen smoked products 
state that the product must remain frozen, that if the product needs 
to be thawed, it must be thawed at refrigerated temperatures, and 
that the product must not be refrozen.
    FDA has authority to adopt these labeling requirements under 
sections 201(n), 403(a), and 701(a) of the act because these 
sections require the inclusion of facts on the food label that are 
material with respect to consequences that may result from use of 
the product under conditions of use prescribed in the label or that 
are otherwise customary or usual. The agency requests comments on 
whether it is necessary to do so.

EXAMPLE 1.--FDA Fish And Fishery Products Hazards And Controls Guide

Table of Contents

    Section I:
    Status
    Purpose
    HACCP
    This Guide and How to Use It
Section II:
    Table 1--Vertebrate Hazard and Control List
    Table 2--Invertebrate Hazard and Control List
    Species Related Hazards and Controls Nos. 1-10
    No. 1 (Safety)--Chemical contamination other than methyl mercury
    No. 2 (Safety)--Methyl mercury
    No. 3 (Safety)--Natural toxins
    3a Paralytic shellfish poisoning (PSP)
    3b Neurotoxic shellfish poisoning (NSP)
    3c Diarrheic shellfish poisoning (DSP)
    3d Amnesic shellfish poisoning (ASP)
    3e Ciguatera food poisoning (CFP)
    3f Clupeotoxin
    3g Chondrichthytoxin
    3h Tetrodotoxin
    3i Gempylotoxin
    No. 4 (Nonsafety)--Filth, extraneous materials or noxious 
substances
    No. 5 (Nonsafety)--Decomposition
    No. 6 (Safety)--Histamine
    No. 7 (Safety)--Food and color additives
    No. 8 (Nonsafety/safety): Parasites
    No. 9 (Safety)--Animal drugs
    No. 10 (Safety)--Pathogenic Microorganisms
Section III:
    Table 3--Process Related Hazards and Controls List
    Process Related Hazards and Controls Nos. 1-22
    No. 1 (Nonsafety)--Filth in dry ingredients
    No. 2 (Nonsafety)--Processing of dead crustaceans and mollusks
    No. 3 (Nonsafety)--Temperature abuse during raw material storage
    No. 4 (Safety)--Excessive water activity
    No. 5 (Safety)--Inadequate salt, sugar, and/or nitrite 
concentration
    No. 6 (Safety)--Pathogen survival during cook
    No. 7 (Safety)--Cross-contamination
    No. 8 (Safety/nonsafety)--Temperature abuse during processing of 
cooked products and raw molluscan shellfish
    No. 9 (Safety/nonsafety)--Temperature abuse during processing of 
noncooked products
    No. 10 (Safety)--Microbiological growth in batter
    No. 11 (Safety)--Pathogen survival during pasteurization
    No. 12 (Safety): Recontamination after pasteurization
    No. 13 (Safety/nonsafety)--Temperature abuse during final 
cooling
    No. 14 (Safety/nonsafety)--Temperature abuse during finished 
product storage
    No. 15 (Safety/Nonsafety)--Temperature abuse during finished 
product distribution
    No. 16 (Safety)--Metal inclusion
    No. 17 (Safety)--Food and color additives
    No. 18 (Nonsafety)--Short weight
    No. 19 (Nonsafety)--Species substitution
    No. 20 (Nonsafety)--Grade size misrepresentation
    No. 21 (Nonsafety)--Incorrect proportions
    No. 22 (Nonsafety)--Over breading
Section IV:
    Finished Product Standards for Use in Verification
Section V:
    Smoked and Smoke-Flavored Fishery Products
    Cooked, Ready-to-Eat Fishery Products
    Scombroid Toxin Forming Species
Section VI:
    Model HACCP Plan

                          Example 2.--Section II                        
              [Table 1--Vertebrate Hazard and Control List]             
------------------------------------------------------------------------
                                                      Safety  Non safety
       Market names            Scientific names      hazards  hazards\1\
------------------------------------------------------------------------
Aholehole................  Kuhlia spp.               .......        4, 5
Alewife/river herring....  Alosa spp.                      1     4, 5, 8
Alfonsino/red bream......  Beryx spp.                .......        4, 5
                           Trachichthodes spp.       .......        4, 5
Amberjacks/yellowtail....  Seriola spp.                3e, 6     4, 5, 8
Anchovy/anchoveta........  Anchova spp.               1, 3f,        4, 5
                           Anchoviella spp.                6        4, 5
                           Cetengraulis spp.            1, 6        4, 5
                           Engraulis spp.               1, 6        4, 5
                           Stolephorus spp.             1, 6        4, 5
Aquaculture species......  Aquatic species,            1, 7,     4, 5, 8
                            (Including                  8, 9            
                            invertebrates, fishes,                      
                            amphibians and                              
                            reptiles)                                   
Angelfish................  Holacanthus spp.               3e        4, 5
                           Pomacanthus spp.          .......        4, 5
Argentine/queenfish......  Argentina elongata        .......        4, 5
Barracouta...............  Thrysites atun            .......        4, 5
Barracuda................  Sphyraena spp.                 3e        4, 5
Bass.....................  Ambloplites spp.             1, 9     4, 5, 8
                           Micropterus spp.             1, 9     4, 5, 8
                           Morone spp.                  1, 9     4, 5, 8
                           Stereolepis gigas            1, 9     4, 5, 8
                           Synagrops bellus             1, 9     4, 5, 8
Bass, sea................  Acanthistius                    8     4, 5, 8
                           Brasilianus               .......     4, 5, 8
                           Centropristis spp.        .......     4, 5, 8
                           Dicentrachus labrax       .......     4, 5, 8
                           Lateolabrax               .......     4, 5, 8
                           Japonicus                 .......     4, 5, 8
                           Paralabrax spp.           .......     4, 5, 8
                           Pranthias furcifer        .......  ..........
                           Polyprion spp.            .......  ..........
------------------------------------------------------------------------
\1\See Table of Contents for key to hazards.                            
Reminder: See process hazard tables beginning on p. 70 for hazards that 
  apply to your product.                                                


                                 TABLE 2.--Invertebrate Hazard and Control List                                 
----------------------------------------------------------------------------------------------------------------
        Market names                 Scientific names            Safety hazards\1\       Non safety hazards\1\  
----------------------------------------------------------------------------------------------------------------
Abalone......................  Haliotis spp.................  1, 3a, 3b, 3c, 3d.......  4, 5                    
Aquacultured invertebrates...  All species (Coelenterates,    1, 3a, 3b, 3c, 3d, 7, 9,  4, 5, 8                 
                                Molluscs, Crustacea, and       10.                                              
                                Echinoderms).                                                                   
Arkshell.....................  Anadara subcrenata Arca spp..  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Carpet Shell...........  Tapes spp....................  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Bentnose...............  Macoma nasuta,...............  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Butter.................  Saxidomus spp................  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Calico.................  Macrocallista maculata.......  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Clovis.................  Tapes virginea...............  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Geoduck................  Panopea spp..................  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Hard...................  Arctica islandica,             3a, 3b, 3c, 3d, 10......  4, 5                    
                                Meretricinae spp. Venus                                                         
                                mortoni.                                                                        
Clam, Hardshell/Quahog.......  Protothaca thaca.............  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Littleneck.............  Protothaca staminea            1, 3a, 3b, 3c, 3d, 10...  4, 5                    
                                Protothaca tenerrima, Tapes                                                     
                                philippinarum.                                                                  
Clam, Manila.................  Tapes semidecussata..........  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
Clam, Pismo..................  Tivela stultorum.............  1, 3a, 3b, 3c, 3d, 10...  4, 5                    
----------------------------------------------------------------------------------------------------------------
\1\See Table of Contents for key to hazards.                                                                    
Reminder: See process hazard tables beginning on p. 70 for hazards that apply to your product.                  

Example 3

Species-Related Hazards and Controls No. 1

Hazard No. 1 (Safety)--Chemical Contamination Other Than Methyl Mercury

    Contamination of Raw Material at Receipt with Pesticides, 
Radioactivity, Toxic Elements, and Industrial Chemicals, Derived 
From the Harvest Area.

Hazard Statement

    Fish and molluscan shellfish may be harvested from waters that 
are exposed to varying amounts of environmental contaminants. 
Industrial chemicals, pesticides, and many toxic elements may 
accumulate in fish at levels that can cause public health problems. 
Concern for these contaminants primarily focuses on fish and 
shellfish harvested from fresh water, estuaries, and near-coastal 
waters rather than from the open ocean. Pesticides and herbicides 
used near aquaculture operations or for other purposes may 
contaminate fish and fishery products.
    Federal tolerances or action levels are established for some of 
the most toxic and persistent contaminants that are found in fish 
and fishery products shipped in interstate commerce. (These 
contaminants and their corresponding limits are listed below.) When 
products exceed these limits, FDA can seize the contaminated fish 
and fishery products.
    States often use the limits for deciding whether to issue 
consumption advisories or to close or classify waters for 
harvesting. Molluscan shellfish waters are controlled by the State 
Shellfish Control Agency (SSCA) or the equivalent in foreign 
countries that have Memoranda of Understanding with the United 
States that permit them to export molluscan shellfish to this 
country. If local or regional contaminants are not covered by 
federal limits, contact local health departments to decide if 
contaminant levels in fish and fishery products are of public health 
concern.
    The control measures provided in this section are appropriate 
for the control of methyl mercury contamination in fish, where such 
contamination is the result of industrial contamination in a harvest 
area. Recommended controls for the problem of open ocean species, 
such as swordfish and shark, concentrating methyl mercury from their 
diet and its diffuse presence in the environment are provided in the 
``Mercury'' hazard section.

Critical Control Point: Receiving

    There are five options for control at this critical control 
point.

Option 1

    Where the firm receives wild caught fish, other than molluscan 
shellfish, directly from the fisher or from a supplier that has 
credible knowledge of the harvest area location (e.g., a tender or 
related company that pools fish from various fishers), the following 
applies:

Control Measures

    1. Find out the harvest area location for each lot or batch from 
the fisher upon receipt.
    2. Find out whether the harvest area is closed to fishing by 
foreign, Federal, State or local health authorities due to known 
instances of chemical contamination.
    3. Reject fish that have been caught in a closed area.

Example

    ABC Fish Co. has contacted the State Department of Health and 
learned that the Long River is closed to commercial harvest above 
Lookout Point, including its tributaries, due to the presence of 
chlordecone (KeponeTM). The species affected are croaker, 
bluefish, and striped bass. ABC Fish Co., which processes these 
species, will reject any of the listed species originating from the 
area.

Frequency

    1. For finding out the location: each lot or batch.
    2. For finding out whether the harvest area is closed: before 
accepting fish from a new area and after that at least quarterly.
    3. For rejecting fish: each lot or batch that does not meet the 
critical limit.

Critical Limits

    Zero tolerance for fish (i.e., accept no fish) harvested from 
areas closed by foreign, State, or local health authorities due to 
chemical contamination.

Records

    A record for each lot or batch that shows the harvest area for 
the fish. Record may be the receipt from the fisher, if it shows the 
harvest area, or it may be a notation on another record of the 
location of harvest for each lot or batch. The description of the 
location should be clear enough to show that the fish were harvested 
from an area that is open to harvesting. Longitude and latitude may 
be necessary (e.g., for open ocean harvesting).

Corrective Actions

    Destroy or recall product that fails to meet the critical limit.
    Any critical limit deviation should cause a timely assessment by 
management to: Decide whether the process or HACCP plan needs 
changing to reduce the risk of recurrence of the deviation, and to 
take appropriate followup action.

Option 2

    Where the firm receives raw fish, other than molluscan 
shellfish, directly from the aquacultural or maricultural producer 
or from a supplier that has credible knowledge of the harvest area 
location (e.g., a tender or related company that pools fish from 
various aquaculturists), the following applies:

Control Measures

    1. Find out the harvest area location for each lot or batch of 
aquacultured fish.
    2. Find out the potential for chemical contamination before 
receipt of the product. This can be done by obtaining or reviewing 
the results of analysis of soil, water, and raw fish samples, as 
needed. Monitor agricultural and industrial practices in the 
aquacultural or maricultural production area.
    3. Reject fish that have been grown in an area where uses of 
agricultural or industrial chemicals are likely to have caused 
contamination of the growing and harvesting environment or where 
soil, water, or fish sample results show chemical contamination.

Example

    ABC Fish Co., which receives pond-raised catfish from the Long 
River delta area, screens potential pond sites either directly or by 
obtaining results of the aquaculturists' analyses of soil and water 
samples.
    The samples are analyzed for pesticides, PCB's, dioxins, and 
petrochemicals. Either ABC Fish Co. representatives visit each pond 
to assess the potential for ongoing chemical contamination, or 
information is obtained from the U.S. Department of Agriculture 
Extension Service about the use of pesticides and herbicides near 
each pond. Where there is a potential for pond contamination, annual 
samples are collected and analyzed for the same contaminants. Fish 
that come from contaminated or suspect ponds are rejected.

Frequency

    1. For finding out the location: each lot or batch.
    2. For learning the potential for contamination: before 
accepting fish from a new growing area, and annually, after that if 
there is a potential for ongoing contamination of the growing area.
    3. For rejecting fish: each lot or batch that does not meet the 
critical limit.

Critical Limits

    Zero tolerance for fish (i.e., accept no fish) produced in an 
area where uses of agricultural or industrial chemicals are likely 
to have caused contamination of the growing and harvesting 
environment.

Records

    Record that shows the production area for each lot of raw 
material. Records describing the assessed risk of chemical 
contamination for all producers.

Corrective Actions

    Destroy or recall product that fails to meet the critical limit.
    Any critical limit deviation should cause a timely assessment by 
management to: Learn whether the process or HACCP plan needs 
modification to reduce the risk of recurrence of the deviation, and 
take appropriate followup action.

Option 3

    Where the firm receives fish, other than molluscan shellfish, 
from someone other than the fisher, aquacultural producer, or a 
supplier that has credible knowledge of the harvest area location 
(e.g., a transportation company that pools fish from various fishers 
or aquaculturists), the following applies:

Control Measures

    1. Periodically monitor the incoming fish for environmentally 
persistent organochlorine pesticides which have the potential to be 
present in the fish. These should include, but are not limited to: 
DDT and its degradation products (DDE, TDE), chlordane, and 
heptachlor, also similar chlorinated industrial chemicals, such as 
PCB's and dioxins. Sampling should represent all suppliers (i.e., 
three samples per supplier per year).
    2. Reject all shipments from suppliers that provide fish that 
exceed the critical limits unless convincing evidence can be 
obtained that only acceptable harvest or growing areas are now being 
used.

Example

    ABC Fish Co. receives brown shrimp from an interstate seafood 
transportation company. The carrier, which buys the shrimp directly 
from the fishers, makes no effort to learn the harvest location. ABC 
Fish Co. collects three samples per supplier per year and sends them 
to a contract laboratory for pesticide screening. When positive test 
results are obtained, the firm stops using that supplier.

Frequency

    1. For sampling incoming fish: three times per supplier per 
year.
    2. For rejecting fish: each lot or batch that does not meet the 
critical limit.

 Critical Limits

    All limits are for the edible portion of the fish product, and 
are based on wet weight:
     Aldrin plus dieldrin, chlordane, endrin, heptachlor 
plus heptachlor epoxide, and chlordecone (KeponeTM): 0.3 ppm in 
edible portion (except chlordecone in crabmeat 0.4 parts per 
million(ppm)) (CPG 7141.01);
     DDT plus TDE plus DDE: 5 ppm (CPG 7141.01);
     Mirex: 0.1 ppm (CPG 7141.01);
     Toxaphene: 5.0 ppm in edible portion (CPG 7141.01);
     PCB's: 2 ppm [CPG 7108.19 and CFR 109. 30 (A)];
     Methyl mercury: 1 ppm (CPG 7108.07).

Records

    Records of analytical results from the firm's own laboratory or 
contract laboratory(s).

Corrective Actions

    Destroy or recall product that fails to meet the critical limit.
    Any critical limit deviation should cause a timely assessment by 
management to: Learn whether the process or HACCP plan needs 
changing to reduce the risk of recurrence of the deviation, and take 
appropriate followup action.

Option 4

    Where the firm receives inshell molluscan shellfish, the 
following applies:

Control Measures

    1. Find out the harvest area location from the harvester's tag 
on the containers of shellfish for each lot or batch of shellfish.
    2. Check the harvester's state commercial fishing license or 
compare the dealer's certification number to those listed in the 
most current edition of the ``Interstate Certified Shellfish 
Shippers List (ICSSL).'' If the dealer is not listed, check for 
certification with the SSCA or equivalent.
    3. Find out whether the harvest area is closed (i.e. classified 
as prohibited) to fishing by a SSCA or equivalent due to chemical 
contamination.
    4. Reject molluscan shellfish harvested from a closed (i.e., 
classified as prohibited) area, or delivered by an unlicensed 
harvester or uncertified dealer, or those not properly tagged.

Example

    The ABC Fish Co. distributes clams, muscles, and oysters to 
restaurants. The shellfish are received from other processors. The 
firm examines the labels of the containers in each lot to learn the 
name, address, and certification number of the last processor. This 
information is compared to the ICSSL to confirm that the product is 
from a certified processor. Containers from uncertified processors 
and inadequately labeled containers are rejected. Contact the State 
Department of Health to confirm certification for unlisted 
processors.

Frequency

    1. For finding out the location: each lot or batch.
    2. For checking licenses and certification: each lot or batch.
    3. For finding out whether the harvest area is closed: before 
accepting shellfish from a new area and as often after that as 
necessary to ensure accuracy.
    4. For rejecting molluscan shellfish: each lot or batch that 
does not meet the critical limit.

Critical Limits

    Zero tolerance for molluscan shellfish (i.e., accept no 
molluscan shellfish) harvested from areas closed (i.e. classified as 
prohibited) by a SSCA or equivalent due to chemical contamination.
    Zero tolerance for molluscan shellfish (i.e., accept no 
molluscan shellfish) delivered by a harvester that is unlicensed or 
a processor that is not certified by a SSCA or equivalent.
    Zero tolerance for molluscan shellfish (i.e., accept no 
molluscan shellfish) that do not bear a tag on each container that 
contains the following information, at a minimum: harvester's name, 
address, the harvester number assigned by the SSCA or equivalent; 
date of harvest; location of harvest by state and site; type and 
quantity of shellfish. Bulk shipments should be identified by a 
bill-of-lading that contains the same information.

Records

    A record for each lot or batch that shows the information from 
the harvester tag or bill of lading, including: name of harvester, 
address, identification number, the date of harvest, location of 
harvest by state and site, quantity and type of shellfish.

Corrective Actions

    Destroy or recall product which fails to meet the critical 
limit.
    Any critical limit deviation should cause a timely assessment by 
management to: learn whether the process or HACCP plan needs 
changing to reduce the risk of recurrence of the deviation, and take 
appropriate followup action.

Option 5

    Where the firm receives shucked molluscan shellfish, the 
following applies:

Control Measures

    1. Find out the name, address, and certification number of the 
last processor from the containers of shucked molluscan shellfish in 
each lot or batch.
    2. Compare the dealer's certification number to those listed in 
the most current edition of the ``Interstate Certified Shellfish 
Shippers List'' (ICSSL), which is published monthly. If the dealer 
is not listed, check for certification with the SSCA or equivalent.
    3. Reject molluscan shellfish not from a dealer certified by a 
SSCA or equivalent, packed in containers not bearing the name, 
address, and certification number of the last processor.

Example

    ABC Fish Co. receives shucked oysters from other processors. The 
firm examines the labels of the containers in each lot to learn the 
name, address, and certification number of the last processor. This 
information is compared to the current ICSSL to confirm that the 
product is from a certified processor. Containers from uncertified 
processors and inadequately labeled containers are rejected. The 
firm contacts the State Department of Health to confirm 
certification for unlisted processors.

Frequency

    1. For finding the certification number: each lot or batch.
    2. For finding out if the processor is certified: each lot or 
batch.
    3. For rejecting uncertified molluscan shellfish: each batch 
that does not meet the critical limit.

Critical Limits

    Zero tolerance for molluscan shellfish (i.e., accept no 
molluscan shellfish) from an uncertified processor.
    Zero tolerance for molluscan shellfish (i.e., accept no 
molluscan shellfish) packed in containers that do not list the name, 
address, and certification number of the last processor.

Records

    Record for each lot or batch that shows the date of receipt, 
type and quantity of shellfish, and name and certification number of 
the last processor.

Corrective Actions

    Destroy or recall product that does not meet the critical limit.
    Any critical limit deviation should cause a timely assessment by 
management to: Learn whether the process or HACCP plan needs 
changing to reduce the risk of recurrence of the deviation, and take 
appropriate followup action.

Example 4

Section III

                          Table 3.--Process-Related Hazards and Controls List Products                          
----------------------------------------------------------------------------------------------------------------
               Finished product                          Safety hazards                  Nonsafety hazards      
----------------------------------------------------------------------------------------------------------------
Cooked crustacean meat, cooked crustacean      3b\1\, 6\2\, 7, 8b, 13b, 14b, 15b  2\4\, 3c\1\, 8c, 13c, 14c,    
 sections, whole crustaceans (except shrimp).   16\3\, 17.                         15c, 18, 19                  
Cooked shrimp................................  6, 7, 8b, 13b, 14b, 15b, 16\3\,    3c, 8c, 13c, 14c, 15c, 18, 20 
                                                17.                                                             
Surimi-based analog products.................  6, 7, 8b, 13b, 14b, 15b, 16, 17..  1, 8c, 13c, 14c, 15c, 18, 21  
Pasteurized crustacean meat and pasteurized                                                                     
 surimi-based analog products (in addition to                                                                   
 hazards identified above).                                                                                     
                                               11, 12...........................  ..............................
Coldsmoked fish (including spreads and dips).  3a\5\b, 5, 7, 9a\5\b, 13a\5\b,     3c, 9c, 13c, 14c, 15c, 18, 19 
                                                14a\5\b, 15a\5\b, 16\3\, 17.                                    
Hotsmoked fish (including spreads, dips,       3a\5\, 5, 6, 7, 8a\5\b, 13a\5\b,   3c, 8c, 13c, 14c, 15c, 18, 19 
 sausages, and jerkies).                        14a\5\b, 15a\5\b, 16\3\, 17.                                    
----------------------------------------------------------------------------------------------------------------
\1\This hazard applies only if a cooked raw material or molluscan shellfish is used.                            
\2\This hazard does not apply to blue crab (Callinectes sapidus), dungeness crab (Cancer magister), or king crab
  (Paralithodes spp.) and golden crab (Lithodes aequispina).                                                    
\3\This hazard applies only to those products that are mechanically produced.                                   
\4\This hazard applies only to live raw material.                                                               
\5\This hazard applies only for scombriod-type species. See Vertebrate Hazard List (Hazard 6-Histamine).        

Example 5

Process-Related Hazard and Control No. 11

Hazard No. 11 (Safety)--Pathogen Survival During Pasteurization

Hazard Statement

    Survival of Clostridium botulinum (C. botulinum type E) or other 
microorganisms of public health concern, through the pasteurization 
process is a food safety hazard for cooked, ready-to-eat products 
packed in hermetically sealed containers and held refrigerated. 
Pasteurization is a process applied to a fish or fishery product 
after that fish or fishery product has been placed in a final, 
hermetically sealed package. The process involves the application of 
sufficient heat (or other processes) for a sufficient time to cause 
the reduction of microorganisms of public health concern to levels 
that, under normal conditions of storage, are unlikely to cause 
disease. C. botulinum type E is a pathogenic microorganism that may 
be found in fish and fishery products.
    Botulism is a severe type of food poisoning caused by the 
ingestion of foods containing the potent neurotoxin formed during 
the growth of C. botulinum. C. botulinum type E can grow and produce 
toxin at temperatures as low as 3.3  deg.C (38  deg.F), and must, 
therefore, be eliminated from the hermetically sealed container 
during the pasteurization process. Pasteurized products that are 
stored, distributed, and displayed in the frozen state, and are so 
labeled, are not similarly at risk, and need not be subjected to the 
constraints of these control measures.
    For there to be assurance that the pasteurization step 
effectively eliminates the microorganisms of public health 
significance (e.g., C. botulinum type E), a minimum acceptable 
process should be scientifically established. This requires expert 
knowledge of thermal process calculations. Procedures used in 
establishing the minimum thermal process should be those that are 
generally recognized and accepted. Sometimes, thermal death time, 
heat penetration, and inoculated pack studies will be necessary to 
establish the minimum process. In other instances, existing 
literature is sufficient to provide the processor with a minimum 
process.
    In either case, characteristics of the process and/or the 
product will necessarily affect the ability of the cook step to 
effectively eliminate the microorganisms of public health 
significance. Such factors should be considered in the establishment 
of the process. Where control of those factors is necessary to 
consistently achieve that goal, the process authority should specify 
these to the processor.
    It is necessary that the pasteurizing equipment be designed and 
operated so that every unit of product receives the established 
minimum process. This will require that a competent process 
authority, who is thoroughly familiar with the dynamics of heat 
transfer in processing equipment, evaluate the design and operation 
of the type of equipment used by the processor. Sometimes 
temperature distribution studies will be necessary to establish the 
adequacy of the equipment. In other instances existing literature 
will be sufficient to establish the adequacy of the equipment.

Critical Control Point: Pasteurization Control Measures

    1. Make sure that the pasteurization process that is being used 
was designed to ensure an appropriate reduction in the numbers of 
viable microorganisms of public health concern. The adequacy of the 
pasteurization process should be established by a process authority. 
The pasteurization process that is being used should meet any 
factors of the process or of the product that are identified by the 
process authority as critical to achieving pathogen destruction. At 
a minimum, these critical factors should include pasteurizing times 
and temperatures.
    2. Make sure that the pasteurization equipment being used is 
properly designed and operated to deliver the process established by 
the process authority. The engineering specifications of the 
equipment being used (e.g., pipe sizes, flow rates, loading pattern) 
should meet or exceed that of the equipment evaluated by a process 
authority.
    3. Deliver the pasteurization process in a way that there is no 
deviation from the minimum established pasteurization critical 
factors.
    4. Monitor the pasteurization temperature with a temperature 
recording device (i.e., temperature recorder). The temperature 
recorder should be installed where it can be easily read and the 
sensor for the device should be installed to ensure that it 
accurately measures the coldest temperature of the pasteurizing 
equipment. The temperature recorder must show a continuous record of 
the process. Computerized storage of temperature data may be used 
for a temperature recorder chart if the use of such a system has 
been validated and can be shown to be equivalent to the use of a 
temperature recorder.
    5. Check the accuracy of each temperature recorder at the 
beginning and end of each production day and adjust it as necessary 
to agree as nearly as possible with a temperature indicating device 
(mercury-in-glass thermometer or equivalent device). The thermometer 
should be installed where it can be easily read and placed to ensure 
that it accurately measures the coldest temperature of the 
pasteurizing equipment.
    6. Calibrate the thermometer at the pasteurizing temperature 
against an accurate standard thermometer. This should be done when 
the thermometer is installed and at least once a year after that, or 
more frequently, if necessary, to ensure its accuracy.
    7. Monitor the length of the pasteurization cycle.
    8. Monitor other critical factors (e.g., initial temperature, 
container size, product formulation) at the start of each shift or 
when the product changes during a shift.

Example

    The ABC Crab Co. produces pasteurized crabmeat. The 
pasteurization process being used has been established by the 
university extension service (a process authority). The process 
provided by the extension service includes limits on how to stack 
the canned product into the pasteurizer, the process temperature, 
and the length of time needed to achieve proper pasteurization.
    The pasteurization equipment being used by ABC Crab Co. is at 
least equivalent to that described by the information received from 
the extension service. It is equipped with both a mercury-in-glass 
thermometer and a recording thermometer. The recording thermometer 
is compared to the mercury-in-glass thermometer during each 
pasteurization cycle. It is adjusted as necessary to meet the 
critical limit. The mercury-in-glass thermometer is calibrated at an 
independent laboratory every 6 months. The temperature of each 
pasteurization cycle is controlled to meet the critical limits using 
the mercury-in-glass thermometer and the length of each cycle is 
controlled using a wall clock. The loading of the cans is checked 
before starting each batch.

Frequency

    1. For making sure that the pasteurization process was properly 
established: before using a pasteurization process.
    2. For making sure that the pasteurizing equipment is properly 
designed: before using pasteurizing equipment.
    3. For properly delivering the process: each lot or batch.
    4. For monitoring the temperature: each lot or batch.
    5. For checking the accuracy of the temperature recorder: at the 
beginning and end of each production day.
    6. For calibrating the thermometer: at installation and at least 
annually after that.
    7. For monitoring the length of the pasteurizing cycle: each lot 
or batch.
    8. For monitoring other critical factors: as often as necessary 
to achieve control.

Critical Limits

    Zero tolerance for product produced with a deviation from the 
minimum established pasteurization process, including such critical 
factors as time, temperature, initial temperature, container size, 
and product formulation.
    The temperature-indicating device should agree within 1  deg.C 
(2  deg.F) of the National Institute of Standards and 
Technology (NIST) traceable thermometer.
    The temperature recording device should be adjusted to agree as 
nearly as possible, but never to be higher, than the temperature 
indicating device.

Records

    A record that describes the results of a scientific evaluation, 
conducted by a process authority, of the adequacy of the 
pasteurizing process. Such document may consist of, but is not 
limited to, a letter from a process authority, articles in 
scientific journals, or Federal, State, or local government 
regulations or advisories.
    A record that describes the results of a scientific evaluation, 
conducted by a process authority, which applies to the design and 
operation of the type of equipment used by the processor.
    A record for each lot or batch that shows the results of the 
pasteurization process. The records should include: the time of day 
that the pasteurization temperature is achieved; the time of day 
that the pasteurization cycle ends; the time of day that the product 
is placed in the water; and, as appropriate, the product size, belt 
speed (continuous pasteurizer), the temperature at the time that the 
processing starts, and any other factors of the process or of the 
product that are identified by the process authority as being 
critical to achieving pathogen reduction.
    Temperature recorder charts or computerized temperature data 
storage. A record of calibration for thermometers that specify the 
date, standard against which the thermometers were compared (NIST-
traceable thermometer), procedure used, results, and person 
performing the test.
    A record of accuracy checks for the temperature recorder that 
specifies the time, date, temperatures shown by the thermometer and 
temperature recorder before adjustment, the corrective action taken, 
and person performing the accuracy check.
    Records of process evaluation by the process authority, where 
deviations from critical limits occurred.

Corrective Actions

    When there has been a failure to maintain appropriate 
temperature, time, or other critical factors of the process or of 
the product, within the critical limits, the affected product should 
be:
     destroyed;
     reprocessed to eliminate the hazard, keeping full 
records of the processing conditions; or,
     segregated and held until an evaluation can be made to 
determine the effect of a deviation. The evaluation should be made 
by a process authority following recognized procedures. Unless the 
evaluation shows that the product has received adequate 
pasteurization, the product should be destroyed or reprocessed to 
eliminate the hazard.
    Indicating or recording thermometers that cannot be adjusted to 
within the critical limits should be repaired or replaced. A 
thermometer that has a divided fluid column should be immediately 
repaired or replaced.
    Any critical limit deviation should cause a timely assessment by 
management to: Learn whether the process or HACCP plan needs 
changing to reduce the risk of recurrence of the deviation, and take 
appropriate followup action.

Example 6

General Guidance for Smoked and Smoke-Flavored Fishery Products

    1. General guidance for smoked and smoke-flavored fishery 
products
    2. Definitions
    3. Critical control points
    4. Thawing
    5. Brining and smoking
    6. Post-smoking
    7. Temperature monitoring equipment
    8. Packaging
    9. Corrective actions
    10. Sanitary zones
    11. Alternative parameters

1. General guidance for smoked and smoke-flavored fishery products

    This section provides consolidated guidance on how to meet the 
requirements of subpart A of 21 CFR part 123, for the processing of 
smoked and smoke-flavored fishery products. This guidance involves 
processing procedures for the control of the microbiological hazards 
to which these products are particularly susceptible. The guidance 
does not apply to finnan haddie, smoked cod fillets, smoked scotch 
kippers, or other smoked fish that are cooked before being consumed, 
because these products will be heated to destroy any potential 
toxins or pathogens. The guidance also does not apply to smoked 
fishery products that are packaged in hermetically sealed 
containers, processed to destroy spores of nonproteolytic C. 
botulinum types B, E, and F, and stored and distributed 
refrigerated, in the same container. These products are covered by 
Appendix A relating to Cooked, Ready-to-Eat fishery products. In 
addition, the guidance does not cover environmental or other hazards 
that might occur before the processor takes possession of its 
product or raw materials. (Guidance on these hazards may be found in 
a separate guidance document for all fish and fishery products 
issued by FDA.)

2. Definitions

    a. Cold-process smoked or cold-process smoked-flavored fish 
means the finished food prepared by subjecting forms of smoked fish 
and smoke-flavored fish to heat for a period of time that does not 
coagulate the protein.
    b. Hot-process smoked or hot-process smoke-flavored fish means 
the finished food prepared by subjecting forms of smoked fish and 
smoke-flavored fish to sufficient heat for a sufficient period of 
time to coagulate protein throughout the fish.
    c. Liquid smoke means an aqueous solution of wood smoke which, 
when suitably diluted, may be used to impart a smoke flavor to fish 
products.
    d. Loin muscle means the longitudinal quarter of the great 
lateral muscle of the fish that is free from skin, scales, visible 
blood clots, bones, gills, and from the nonstriated part of such 
muscle, which part is known anatomically as ``the median superficial 
muscle.''
    e. Modified atmosphere-packaging means the food-packaging 
technique in which the air in a package or container is replaced by 
one or more gases, in various concentrations, before sealing. The 
purpose of this type of packaging is to extend the refrigerated 
shelf life of the product by limiting microbial growth or 
detrimental chemical changes in the food.
    f. Smoked-flavored fish means fish that is prepared by treating 
it with salt (sodium chloride) and then imparting to it the flavor 
of smoke by other than the direct action of smoke, such as immersing 
it in a solution of liquid smoke. This paragraph does not alter the 
labeling requirements under Sec. 101.22 of this chapter.
    g. Smoked fish means fish that is prepared by treating it with 
salt (sodium chloride) and then subjecting it to the direct action 
of smoke from burning wood, sawdust, or similar material.
    h. Sodium nitrite content means the concentration in parts per 
million of sodium nitrite in the loin muscle of the finished product 
as determined by the method of analysis for sodium nitrite in the 
``Official Methods of Analysis of the Association of Official 
Analytical Chemists,'' 15th ed. (1990).
    i. Vacuum-packaged means the food-packaging technique in which 
the air in a package or container is removed before sealing.
    j. Water-phase salt content means the percent salt (sodium 
chloride) in the finished product as determined by the method of 
analysis for water-phase salt on the ``Official Methods of Analysis 
of the Association of Official Analytical Chemists,'' 15th ed. 
(1990). It is measured in the loin muscle of whole, dressed fish and 
in the thickest part of cuts of fish.

3. Critical Control Points

    Hazards Analysis Critical Control Point (HACCP) plans prepared 
in accordance with subpart A of 21 CFR part 123, will typically 
identify and address the following critical control points:
    a. Raw material thawing
    b. Brining or dry salting
    c. Drying
    d. Smoking
    e. Cooling after smoking
    f. Post-smoke processing, if any
    g. Final product cooling
    h. Refrigerated storage
    i. Distribution
    In accordance with subpart A of 21 CFR part 123, processors 
shall identify in their HACCP plans how they will control hazards at 
critical control points. The measures in sections 4 through 11 of 
this guidance are suitable for HACCP plans.

4. Thawing

    Thawing should be carried out in as rapid a manner as possible, 
so that the internal temperature at the core of the fish does not 
exceed 40  deg.F (4.4  deg.C).

5. Brining and smoking

    a. Products covered by this guidance should be subjected to one 
of the following processes:
    (1) Hot-process smoked or hot-process smoke-flavored fish to be 
air packaged needs to be heated to a continuous internal temperature 
of at least 145  deg.F (63  deg.C) throughout each fish for a 
minimum of 30 minutes, and brined to contain not less than 3.0 
percent water-phase salt in the finished product (except that smoked 
chub containing sodium nitrite as provided for in Sec. 172.177 of 
this chapter must be processed as described in that section); or
    (2) Hot-process smoked or hot-process smoked-flavored fish to be 
vacuum packaged, modified atmosphere packaged, or controlled 
atmosphere packaged, needs to be heated to a continuous internal 
temperature of at least 145  deg.F (63  deg.C) throughout each fish 
for a minimum of 30 minutes. It also needs to be brined to contain 
not less than 3.5 percent water-phase salt in the finished product. 
However, where sodium nitrite is present at not less than 100 parts 
per million (as permitted by Secs. 172.175 and 172.177 of this 
chapter) the water-phase salt content in the finished product should 
not be less than 3.0 percent; or
    (3) Cold-process smoked fish and cold-process smoke-flavored 
fish to be air-packaged should be brined or dry salted to contain at 
least 3.5 percent water-phase salt in the finished product. However, 
when such fish contains not less than 100 parts per million sodium 
nitrite, it should contain not less than 3.0 percent water-phase 
salt in the finished product. When cold-process smoked fish or cold-
process smoked-flavored fish to be air-packaged is frozen 
immediately after smoking and cooling, and remains frozen throughout 
subsequent storage and distribution, it should contain not less than 
2.5 percent water-phase salt in the finished product. Cold smoked 
and cold smoke-flavored fish to be air packaged should be processed 
under one of the following sets of conditions:
    (i) The temperature in the smoking chamber does not exceed 90 
deg.F (32  deg.C) during a drying and smoking period that does not 
exceed 20 hours, or
    (ii) The temperature in the smoking chamber does not exceed 50 
deg.F (10  deg.C) during a drying and smoking period that does not 
exceed 24 hours.
    (iii) For sablefish, the temperature in the smoking chamber does 
not exceed 120  deg.F (49  deg.C) during a drying and smoking period 
that does not exceed 6 hours; or
    (4) Cold-process smoked fish and cold-process smoke-flavored 
fish, to be vacuum packaged, modified atmosphere packaged, or 
controlled atmosphere packaged should be brined to contain at least 
3.0 percent water-phase salt in the finished product and not less 
than 100 parts per million of sodium nitrite (where permitted by 
Secs. 172.175 and 172.177 of this chapter) and should be processed 
as described in section 5(a)(3)(i) or (a)(3)(ii) of this Appendix. 
If sodium nitrite is not used, the water-phase salt content in the 
finished product should be at least 3.5 percent.
    b. Brining and dry salting operations should be conducted in a 
manner that will consistently result in the water phase salt content 
or sodium nitrite level (where permitted by Secs. 172.175 and 
172.177 of this chapter) recommended by section 5.a. of this 
Appendix. This should be achieved by conducting or obtaining a study 
that establishes that the appropriate salt content or sodium nitrite 
level is always met under prescribed processing conditions. The 
study should establish the limits of significant variables that 
could affect the ability of the product to reach the appropriate 
levels. These variables may include product size, product condition, 
soak time, soak temperature, salt-to-water ratio, and product-to-
brine ratio. An adequate study should consist of at least three 
processing runs under the prescribed processing conditions. In this 
case, the processor should monitor and record the prescribed 
processing conditions identified by the study at least every 2 
hours.
    c. The brining of all fish should take place in a refrigerated 
area at 40  deg.F (4.4  deg.C) or lower.
    d. The temperature of the brine should not exceed 60  deg.F 
(15.6  deg.C) at the start of brining. The temperature of the brine 
at the start of the each brining process should be determined and 
recorded.
    e. For dry salting, the fish should be returned to a 
refrigerated area of 40  deg.F (4.4  deg.C) or lower immediately 
after the application of the salt.
    f. Different species of fish and fish of dissimilar size and 
weight should not be mixed in the same brining tank.
    g. Brines should not be reused unless they are subject to a 
process that effectively returns them to a microbiological condition 
equivalent to the original, unused brine made with potable water and 
food-grade salt.
    h. Fish may be rinsed with potable water after brining.
    i. Drying of a product to be cold-smoked should be carried out 
in a refrigerated area at 40  deg.F (4.4  deg.C) or below.
    j. Smoking operation.
    (1) Fish should be arranged without overcrowding and without 
touching each other within the smokehouse oven or chamber to permit 
uniform smoke absorption, heat exposure, and dehydration. Fish 
smoked in the same smoke chamber load should be of relatively 
uniform size and weight.
    (2) Liquid smoke, generated smoke, or a combination of liquid 
smoke and generated smoke needs to be applied to all surfaces of the 
product. Liquid smoke may be applied to the product before, at the 
beginning, or during the process. If only generated smoke is to be 
used, it needs to be applied to the fish during the first half of 
the process. If a combination of liquid smoke and generated smoke is 
used, the generated smoke may be applied at any stage of the 
process.
    k. Each smoking chamber should be equipped with a temperature 
recording device to indicate the temperature of the air and of the 
fish within the smoking chamber. Additionally, each chamber should 
be equipped with a temperature indicating device to indicate the 
temperature of the air within the smoking chamber.
    l. During hot-smoking or cold-smoking, a temperature recording 
device should be used to monitor both the internal temperature of 
the fish and the ambient temperature of the smoking chamber. The 
internal temperature readings should be obtained by inserting probes 
from the temperature recording device into the thickest flesh 
portion of three or more of the largest fish in the smoking chamber. 
The temperature from the slowest heating fish should be considered 
the processing temperature.

6. Post-Smoking

    a. Cooling after smoking. After smoking, the product needs to be 
rapidly cooled to minimize recontamination. Continuous cooling from 
140  deg.F (60  deg.C) to achieve an internal temperature of 70 
deg.F (21.1  deg.C) or below within 2 hours and an internal 
temperature of 40  deg.F (4.4  deg.C) or below within an additional 
4 hours, unless processing after smoking as described in section 
6.b. of this Appendix, occurs during either of these time periods, 
will effectively minimize recontamination. Other time/temperature 
parameters may also be effective. Processors should ensure that the 
cooling parameters are met by either:
    (1) Monitoring. Monitoring and recording internal product 
temperatures at least every 2 hours; or
    (2) Studies.
    i. Conducting or obtaining a study that establishes that 
appropriate cooling temperatures are always met under prescribed 
processing conditions. The study should establish the limits of 
significant variables that could affect the rate of cooling. These 
variables may include product size, ambient air temperature, and 
amount of product in the cooler. An adequate study should consist of 
at least three processing runs under the prescribed processing 
conditions; and
    ii. Monitoring and recording the prescribed processing 
conditions as identified by the study in section 6.a.2.i. of this 
Appendix at least every 2 hours.
    b. Processing after smoking. Products that will receive 
processing after smoking should not be exposed to ambient 
temperatures of 40  deg.F (4.4  deg.C) or higher for longer than a 
cumulative total of 4 hours after smoking. If they are exposed to 
such temperatures for more than 4 hours, unacceptable 
recontamination is the likely result. Processors are required to 
regularly monitor and record the length of time that the product is 
exposed to temperatures above 40  deg.F (4.4  deg.C) under 21 CFR 
123.8. FDA recommends that such monitoring and recording be done at 
least every 2 hours.
    c. Final product cooling. To avoid microbiological hazards for 
perishable finished products, the internal temperature of the 
finished product should be 40  deg.F (4.4  deg.C) or below within 4 
hours of placement in a finished product container. Processors 
should either conduct:
    (1) Monitoring. Monitor and record internal product temperatures 
at least every 2 hours; or
    (2) Studies.
    i. Conduct or obtain a study that establishes that the internal 
temperature of the finished product will always be 40  deg.F (4.4 
deg.C) or below within 4 hours of placement in a finished product 
container under prescribed processing conditions. The study should 
establish the limits of significant variables that could affect the 
rate of cooling. These variables may include product size, ambient 
air temperature, and amount of product in the cooler. An adequate 
study should consist of at least three processing runs under the 
prescribed processing conditions; and
    ii. Monitoring and recording the prescribed processing 
conditions as identified by the study in section 6.c.2.i. of this 
Appendix at least every 2 hours.
    d. Refrigerated storage.
    (1) In-process products. Refrigeration units that are being used 
to store in-process products or finished products must operate at a 
temperature of 40  deg.F (4.4  deg.C) or below in accordance with 21 
CFR 123.10(a)(14).
    (2) Temperature devices. Units should be equipped with both a 
temperature-indicating device and a temperature-recording device. In 
lieu of a temperature-recording device, a processor may equip a 
refrigeration unit with a high temperature alarm or a maximum-
indicating thermometer and maintain a temperature log that notes 
temperature with such frequency as is necessary to achieve control.
    e. Distribution. All perishable finished products should be 
distributed in a manner that ensures that the internal temperature 
is maintained at 40  deg.F (4.4  deg.C) or below.

7. Temperature Monitoring Equipment

    Where reference is made in this Appendix to temperature-
indicating devices and temperature-recording devices, the following 
conditions should apply:
    a. Temperature-indicating devices. Temperature-indicating 
devices should be installed where they can be easily read and 
located to ensure that they accurately measure the warmest 
temperature of the refrigeration equipment and the coldest 
temperature of the smoking equipment, as appropriate. Temperature-
indicating devices should be calibrated at the routine operating 
temperature of the refrigeration, cooling, or smoking equipment 
against a known accurate standard thermometer upon installation and 
at least once a year thereafter, or more frequently, if necessary, 
to ensure their accuracy. Records of accuracy checks for 
temperature-indicating devices required to be maintained under 21 
CFR 123.8 should specify the date, standard used, method used, 
results, and person performing the test. A temperature-indicating 
device that has a divided fluid column or that cannot be adjusted to 
the standard should be immediately repaired or replaced.
    b. Temperature-recording devices. Temperature-recording devices 
should be installed where they can be easily read and the sensors 
for such devices should be installed to ensure that they accurately 
measure the warmest temperature of the refrigeration equipment and 
the coldest temperature of the smoking equipment, as appropriate. 
Computerized storage of temperature data may be used in place of 
recorder thermometer charts if the use of such a system has been 
validated and can be shown to be substantially equivalent to the use 
of a temperature-recording device. Each temperature-recording device 
should be checked for accuracy at the beginning and end of each 
production day and adjusted as necessary to agree as nearly as 
possible with the reference temperature-indicating device. A record 
of these accuracy checks should be maintained that specifies the 
time, date, temperatures indicated by both devices before 
adjustment, corrective action taken, where applicable, and person 
performing the accuracy check.

8. Packaging

    a. Vacuum- or modified atmosphere-packaging should be conducted 
only within the facilities in which the product is produced.
    b. Permanently legible code marks should be placed on each 
finished product package and shipping container. These marks should 
identify the plant where the product was packed and the date of 
packing.

9. Corrective Action

    Under 21 CFR 123.7, whenever a deviation occurs at a critical 
control point, the processor is required to segregate and hold the 
product until a review can be made to determine the effect of that 
deviation and take corrective action as necessary. For smoked and 
smoke-flavored fishery products, when a deviation occurs at a 
brining or smoking critical control point, the processor should meet 
the requirements of Sec. 123.7 either by destroying the product; by 
fully reprocessing, where possible, that portion of the production 
involved, keeping full records of the reprocessing conditions; or by 
setting aside that portion of the product involved for further 
evaluation as to any potential public health significance. Such an 
evaluation should be made by a process authority and should be in 
accordance with procedures recognized by process authorities as 
being adequate to detect any unacceptable hazard to public health. 
Unless this evaluation demonstrates that the product had been 
rendered safe for its intended use, the product set aside should be 
either fully reprocessed to correct the deficiency or destroyed. A 
record should be made of the evaluation procedures used and the 
results. Either upon completion of full reprocessing or after the 
determination that no significant public health hazard exists, that 
portion of the product involved may be shipped in normal 
distribution. Otherwise, the portion of the product involved should 
be destroyed.

10. Sanitary Zones

    In addition to the requirements of 21 CFR 123.10, sanitary zones 
should be established around areas in which a smoked product is 
handled or stored. In such areas, objects and employees that have 
come into contact with waste, raw product, or other insanitary 
objects are excluded. Packaging material, equipment, employees, and 
in-process materials that enter a sanitary zone should be treated in 
a manner that will minimize the risk of the introduction of 
microorganisms. Air handling systems should be designed to minimize 
the risk of airborne contamination into sanitary zones and to 
provide positive air pressure in the sanitary zone relative to the 
surrounding areas.

11. Alternative Parameters

    A processor of smoked or smoke-flavored fishery products may use 
parameters other than those provided in Appendix C, section 5.a., if 
those parameters will achieve the following, as demonstrated by 
adequate scientific studies:
    (1) For botulism, zero toxin production in the product through a 
time period slightly beyond the shelf life of the product, 
demonstrated through inoculated pack studies under normal and 
moderate abuse conditions, and
    (2) For listeria, no detectable Listeria monocytogenes in the 
final product. A processor using alternative parameters should have 
on file, subject to the requirements of 21 CFR 123.8(d), a 
description, including the results of, the scientific studies.

Example 7

Section VI

Model HACCP Plan

Establishment Name-----------------------------------------------------
Establishment Address--------------------------------------------------
Mailing Address--------------------------------------------------------

Date and Authorization of HACCP Plan(s) Activation:

Product----------------------------------------------------------------
Critical Control Point-------------------------------------------------
    1. What is the hazard at this critical control point?
    2. Describe your control measures.
    3. What is your frequency of control?
    4. What are your critical limits?
    5. What records are kept of control measures?
    6. What corrective action will you take when the product fails 
to meet the critical limits?

[FR Doc. 94-1592 Filed 1-21-94; 4:31 pm]
BILLING CODE 4160-01-P