U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
Proposed Seafood HACCP Rule
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FN94-01 PROPOSED SEAFOOD HACCP RULE 02/10/94
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.
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 (insert date 90 days after date of
publication in the FEDERAL REGISTER). 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 guideance 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. l). 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. l). 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. l) 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
insure 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 ( 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 xF 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 a 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. l). 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 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
become 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
he appropriateness, and thus providing a rational basis, for
FDA's proposed course of action.
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About 300 pages of proposed regulations follow this
introductory material. Users wanting full text of this
material should download the self-extracting compressed
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HACCPREG.EXE
Download this file using Y modem or X modem protocol.
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