See correction: Federal Register, March 3, 1994
[Federal Register: January 28, 1994]
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Part II
Department of Health and Human Services
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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 impor