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OCR for page 179
Scientific Criteria and
Performance Standards to Control Hazards
in Seafood
The word "seafood" encompasses a vast array of animals that include not only
various genera and species, but also various phylla such as mollusca (e.g., clams
and oysters), arthropoda (e.g., crabs and crayfish), and chordata (e.g., finfish).
This diversity manifests itself in life forms of different sizes, shapes, and func-
tions, each adapted to unique environments and roles within the ecosystem. More
than 350 species of fish are commonly consumed (FAO, 2002~. In a culinary
sense, this diversity is expressed as a broad spectrum of sensory attributes, product
forms, and preparations that are particular to seafood. Whether from traditional
harvest or aquaculture production, seafood presents some unique safety concerns
that arise from both the intrinsic characteristics of the animals and the environ-
mental conditions from which they are harvested. For example, for some species,
food safety issues are dependent on the harvest location and season. In addition,
as is the case with meat and poultry products, conditions and handling at harvest
and processing, as well as through distribution and final preparation, constitute
significant factors that enhance or reduce the risk of seafood-borne disease.
Because of these unique features, certain seafood may present a hazard to
public health. First, given the diversity of aquatic animals and environmental
conditions within the aquatic environment saltwater, freshwater, estuarine
water, tropical, polar, in-shore, off-shore, pristine, polluted it is not surprising
that specific animals and environmental conditions may result in products unsafe
for consumption. Interestingly, most seafood safety problems are present prior to
harvesting and are a consequence of the accumulation of natural contaminants in
the aquatic environment, such as the presence of Vibrio vulnificus in raw molluscan
shellfish or methyl mercury in various fish from certain waters (IOM, 1991~.
179
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180
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
Second, although the expansion of aquaculture production would seem to offer
opportunities for greater environmental control, concerns similar to those of land-
based muscle foods have emerged; such is the case with the presence of therapeutic
agents and human pathogens in seafood as a consequence of the production
environment and practices. Third, all these concerns are further complicated by
an increasing dependence on seafood products from some international waters,
which are subject to less surveillance by domestic authorities than are American
waters.
Additional factors that increase the risk of seafood as foodborne disease
vehicles relate to handling, distribution, and preparation. For example, unique
and notable characteristics of seafood consumption are that a significant portion
is consumed live (e.g., oysters, mussels, and clams), raw (e.g., sushi), or cooked
to a rare state (e.g., cod and mahi-mahi). Also, many recipes include consumption
of nonmuscle components such as eyes, eggs, and viscera (raw and cooked),
some of which may pose unique risks. In addition, the fact that seafood is the
largest commodity group with an extensive recreational element can have serious
public health implications. For example, recreational fishermen can thermally
abuse scombroid-susceptible species, leading to scombroid fish poisoning, an
acute illness associated with the consumption of certain fish having elevated
levels of biogenic amines. These elevated levels are a result of growth of certain
bacteria when temperature abuse of fish occurs during or after harvesting
(CFSAN, 2001~. Furthermore, vacationers have been known to ignore or mis-
understand posted advisories prohibiting the harvest of molluscan shellfish from
nonapproved waters, thus exposing themselves and their families to potentially
contaminated toxic shellfish. It is believed that some recreationally harvested
seafood enters commercial channels (e.g., when sold directly to restaurants),
which could also contribute to outbreaks attributed to commercially produced
seafood. The true extent to which this practice occurs is not known, but recent
undercover investigations have revealed illegal fish sales from recreational har-
vest exceeding six figure incomes for the culprits (Waters, 2002~. Bootlegging,
which is the sale of molluscan shellfish illegally harvested from closed areas, is
another issue with significant food safety implications, but the true extent of the
problem is not known.
Listeria monocytogenes and the debate over zero tolerance have not escaped
the seafood industry. As with other muscle protein foods, the concern with sea-
food is focused on ready-to-eat products. Especially problematic are products
such as fresh crabmeat and cold-smoked fish. The processes involved are tradi-
tional for the respective products, but are relatively uncommon for most meat-
type products. Fresh crabmeat, for instance, does have a terminal heat step that
destroys most foodborne pathogens, including Listeria, but it precedes the meat
removal step, which is traditionally done by hand. With respect to cold-smoked
fish, this product does not have a lethal heating step, therefore other parameters,
such as salt concentration, become important risk minimization steps.
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CONTROLS FOR HAZARDS IN SEAFOOD
DESCRIPTION OF THE SEAFOOD INDUSTRY
181
Although the United States seafood-processing sector includes approximately
5,000 firms (Fisheries Statistics and Economics, 2002), fewer than 20 percent of
these firms produce over 80 percent of the products. When the Food and Drug
Administration (FDA) issued the Procedures for the Safe and Sanitary Processing
and Importing of Fish and Fishery Products; Final Rule (the seafood HACCP
rule) (FDA, 1995), a significant objective was to apply it primarily to the process-
ing sector, even though many factors outside the processing plant contribute to
risks from seafood consumption. The processing sector is more identifiable,
accessible, and controllable than the harvesting, distribution, and transportation
sectors; moreover, it is more concentrated than retail or food service operations.
However, although the processing sector can be better monitored, the abundance
of small processing operations has added complexity to the implementation of,
and compliance with, the seafood HACCP rule. These smaller firms which are
a majority in the processing sector often have limited financial resources and
operations that are significantly influenced by seasonal fluctuations in supply and
demand. This situation has discouraged long-term investments and has created a
specialized industry that is dependent on imported products.
Current trends in international seafood commerce further add to the com-
plexity of the food safety aspects derived from seafood diversity and the unique-
ness of the industry. In 2000, the estimated total international trade in fishery
commodities, by volume (live weight equivalents) and including aquaculture,
was approximately 37 percent of the total world production (FAO, 2000~. In
terms of value, exports from developing countries in 2000 represented over 50
percent of total exports of fishery products (FAO, 2000~. International trade is
expected to increase in response to efforts by various industrialized nations to
supplement their dwindling domestic seafood resources. Supply is becoming the
most significant issue in the world of seafood commerce. The anticipated signifi-
cant shortfalls for the next decade may result in the reduced availability of sea-
food and elevated prices in industrialized countries, while serious shortages could
occur in regions of the world that are dependent on subsistence fisheries.
This situation could influence international decisions relative to seafood
safety, and because over 50 percent of domestic seafood consumption involves
imported products (Figure 5.1), it should be thoroughly considered when devel-
oping food safety regulations in the United States. Imports to the United States
exceed 80 percent for certain popular seafood products. FDA recently estimated
that over 8,500 importing firms are subject to surveillance in accordance with the
seafood HACCP rule.
A relatively recent additional development in world fisheries production is
an increase in dependence on aquaculture products, illustrated by the growth in
the volume of cultured shrimp, one of the most prominent aquaculture products in
the world (Figures 5.2 and 5.3~. There is a need to develop specific strategies to
OCR for page 182
182
o
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
5,000,000- ,
4,000,000 - ,
3,000,000- ,
a_
In,, 2,000,000- ,
° 1,000,000- ~
to
ct O- ~
o
—1 ,000,00a
—2,000,00
—3,000,00
~ Imports ~ Exports ~1 Trade balance
.....................................
. l . _ ,
l _
~—~ t
. _ ~ i ~ T I
North America South America
Europe Asia Africa/Oceania
Continent
FIGURE 5.1 United States trade in edible fishery products during 2000.
SOURCE: Fisheries Statistics and Economics Division (2001a, 2001b).
Wild harvest
3-
~n
~ 2
c'
. _
. _
Aquacultured
.O, 11 ~ I
_ 1 1 1 1 1
o
1988 1990 1992 1994 1996 1998
Year
FIGURE 5.2 World shrimp production, 1988-1998: wild vs. aquaculture.
SOURCE: FAO (2000).
OCR for page 183
CONTROLS FOR HAZARDS IN SEAFOOD
8-
7-
6-
5-
u'
o
4- ~
. _
m 3_
2-
183
1988 1990 1992 1994 1996 1998
Year
FIGURE 5.3 World volume and value of aquaculture production of shrimp, 1988-1998.
SOURCE: FAO (2000).
address the unique challenges presented by aquaculture production of seafood
(e.g., indigenous levels of Salmonella and use of unapproved antibiotics). For
example, recent evidence for residual chloramphenicol (an illegal antibiotic) in
aquaculture shrimp from various Asian farms and processing plants in China,
Vietnam, and Thailand resulted in major product recalls involving numerous
retail operations in the United States and Europe (Louisiana Department of Agri-
culture and Forestry, 2002; NFI, 2002a, 2002b). At one point the European Union
banned the import of cultured shrimp from China and neighboring countries with
shrimp aquaculture. Regulatory response in the United States was initiated by
state agencies and there was general confusion concerning the proper sampling
methods and analytical procedures for residual detection in the parts per billion
range.
REVIEW OF CURRENT FOOD SAFETY CRITERIA FOR SEAFOOD
Current Food Safety Criteria
FDA and the U.S. Environmental Protection Agency (EPA) have established
various food safety criteria that address the intrinsic nature of seafood (e.g.,
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84
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
scombrotoxicity) or characteristics of the environment from which it was har-
vested (e.g., paralytic shellfish toxin, methyl mercury, fecal coliforms). The
current list of regulations intended to ensure the safety of seafood that is harvested
or cultured domestically or is imported reflects the extreme and unique diversity
of this food group. Among these regulations are microbiological criteria associ-
ated with specific microorganisms, such as Salmonella and Clostridium botuli-
num, and with product categories, such as ready-to-eat products and molluscan
shellfish.
The traditional approach used by FDA to develop performance standards for
food safety can be a somewhat slow and lengthy process or it can be a precipitous
one resulting from the agency's need to react to a sudden crisis. Irrespective of
how they are developed, once seafood safety criteria are in place, there is no
mechanism for periodic review to modify or rescind them. This poses a challenge
because the previously mentioned increasing dependence on international sea-
food sources and aquaculture products is introducing new regulatory challenges
not fully anticipated in prior regulations.
As reliance on international supply and demand for seafood items continues
to increase in terms of both product volume and diversity, food safety issues will
become more challenging and varied. Therefore, the committee concludes that
food safety regulations will need periodic review by the regulatory agencies to
remain up-to-date (i.e., to be aligned with current science, commercial practice,
and public health objectives) in such an evolving situation. These reviews should
be conducted by the regulatory agencies and include discussions that address not
only the safety issues associated with the products and their sources, but also the
capacity of regulators to communicate the food safety risks and to enforce com-
pliance within the existing regulatory frameworks in both the domestic and inter-
national settings. The reviews must prioritize the issues in need of more immediate
attention, based on the application of risk assessment.
The HACCP System for Seafood Safety Control
Concerns within industry, government, and consumer groups about the need
to improve seafood safety began in the 1980s and eventually culminated in the
federally mandated seafood HACCP rule. This rule was initially proposed on
January 28,1994 (FDA, 1994) and published in final form on December 18,1995
(FDA, 1995), with an implementation date of December 18, 1997. As a regula-
tion based on HACCP, the seafood HACCP rule was based on identification and
implementation of preventive critical control points (CCPs), with processors
responsible for development and maintenance of the program. (Processor is
defined in the HACCP rule as any person engaged in commercial, custom, or
institutional processing of fish or fishery products, either in the United States or
in a foreign country; persons engaged in the production of foods that are to be
used in market or consumer tests are also included. Persons who only harvest or
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CONTROLS FOR HAZARDS IN SEAFOOD
185
transport seafood, without otherwise engaging in processing, are not covered by
these regulations [FDA, 19941.)
The seafood HACCP system differs from that in the meat and poultry indus-
try in that government inspections are not performed on a continuous, on-site
basis. One reason for this is that such a program is difficult to justify due to the
wide variety of species, variable sources, and diverse product forms characteris-
tic of the seafood industry. Most importantly, however, organoleptic inspections
of freshly harvested marine species would be of little significance in terms of
product safety. Moreover, because such performance standards as specific patho-
gen reductions are not included in the seafood HACCP rule, verification testing is
not part of the FDA inspection. Seafood safety concerns are not dominated by
any single pathogen or contaminant. Data reported by the Centers for Disease
Control and Prevention (CDC, 2000) indicate that from 1993 through 1997,
seafood was the vehicle of transmission in 6.8 percent of the total foodborne
disease outbreaks during this period, but involved less than 3 percent of the total
cases. The percentage of outbreaks associated with shellfish was 1.7 percent, and
fish (species other than shellfish) were associated with 5.1 percent of the out-
breaks. Most of the outbreaks associated with fish were the result of chemical
hazards such as ciguatoxin and scombrotoxin (CDC,2000~. It is important to note
that the seafood HACCP rule did not replace existing regulations and that, there-
fore, it must be implemented along with Good Manufacturing Practices (GMP)
(21 C.F.R. part 110) as foundational prerequisites. Required monitoring and
recording of sanitation control procedures (21 C.F.R. part 123) are also pre-
requisites for implementing a HACCP plan.
Although the National Marine Fisheries Service of the U.S. Department of
Commerce conducts a fee-for-service National Seafood Inspection Program
derived from the Agricultural Marketing Act of 1946, the inspection is voluntary.
In addition, these inspections are designed to ensure compliance with minimum
sanitation practices and product-grade standards, not with the HACCP rule.
Inspections, whether of domestic or imported products, are carried out for quality
purposes, not for safety.
Application of Food Safety Criteria in HACCP
FDA has been responsible for developing an extensive list of seafood regula-
tions (see Appendix C). Many of these regulations consist of food safety criteria
categorized as tolerances, action levels, and guidelines with the underlying
purpose of protecting public health through adherence to GMPs and the preven-
tion of product adulteration and misbranding. While public health is a common
goal for all criteria, the specific scientific basis for each of them differs, depend-
ing mainly on the availability of data about a hazard. As examples, the tolerance
for methyl mercury content in fish (1.0 ppm) is based on the level necessary for
consumer safety, the labeling requirement for sulfite residues (10 ppm) is based
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86
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
on the lower limit of analytical capability, and the fecal coliform standard for
shellfish harvesting waters is based on the potential presence of microbial and
viral pathogens. Apart from scientific data, there are other factors that have been
considered when establishing seafood safety criteria, such as the perception of
risk by the public or the availability of technologies that reduce the hazard to a
level of public protection deemed appropriate by FDA. Although the final deci-
sion regarding development or modification of a food safety criterion resides
with FDA, the rule-making process requires periods of review by and comment
from the various stakeholders, which unavoidably make it a slow process.
As mentioned previously, all food safety criteria established prior to the
seafood HACCP rule remain in place within the current regulatory system; thus,
in addition to HACCP, processors are obligated to produce seafood that comply
with all relevant food safety criteria. In most cases these criteria are not useful for
inclusion as critical limits for CCPs in HACCP plans; however, they can be used
as verification criteria in situations where end-product testing may be warranted.
The National Advisory Committee on Microbiological Criteria for Foods
(NACMCF), an advisory body to federal food safety agencies, specifically
addressed the issue of microbial criteria with the following statement: ". . . the
use of microbiological testing is seldom an effective means of monitoring CCPs
because of the time required to obtain results. In most instances, monitoring of
CCPs can best be accomplished through the use of physical and chemical tests
and through visual observations. Microbiological criteria do, however, play a role
in verifying that the overall HACCP system is working" (NACMCF, 1998~.
Although the NACMCF statement is focused specifically on microbiological
criteria, the same rationale could apply for many of the food safety criteria the
regulatory agencies have developed for chemical hazards. Although EPA and
FDA have established limits for some chemical contaminants, direct monitoring
with analytical tests for chemical contaminants in seafood is often impractical as
a CCP because the variability in concentration for some of these contaminants
among geographic areas is significant and required sampling would be impracti-
cal. As an alternative, the geographical variability in contaminant concentration
indicates that the potential exists for reducing exposure through restrictions of
harvesting sites (IOM, 1991~. As the FDA Fish and Fisheries Products Hazards
and Controls Guide states, such a CCP could be described as follows: "No fish
may be harvested from an area that is closed to commercial fishing by foreign,
federal, state, or local authorities; and no fish may be harvested from an area that
is under a consumption advisory by federal, state, or local regulatory authority
based on a determination by the authority that fish harvested from the waters are
reasonably likely to contain contaminants above the federal tolerances, action
levels, or guidance levels" (CFSAN, 2001~.
Chemical hazards that are not of environmental origin (i.e., biogenic amines,
such as histamine) require a different control strategy. Elevated biogenic amine
levels, a potential food safety hazard in some finfish such as tuna, mackerel, and
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CONTROLS FOR HAZARDS IN SEAFOOD
187
mahi-mahi, are produced as a result of the growth in fish of certain indigenous
bacteria during improper cooling or storage conditions. FDA has established an
action level of 50 ppm histamine in any edible portion of the fish (CFSAN,2001~.
Monitoring of histamine levels in each fish received at a processing plant is
impractical, expensive, and not a viable method of control by seafood processors.
In contrast, review of the harvest records time and temperature associated
with each lot of fish is deemed an acceptable alternative. If this control alternative
is used, harvest vessel records for each lot must include the following informa-
tion: "1) Icing on-board the harvest vessel was performed in accordance with the
vessel's cooling rate study that validates cooling to 50°F [10°C] or below within
6 hrs of death regardless of maximum exposure temperature, or placement in ice
within 12 hrs of death if the maximum exposure temperature does not exceed
83°F [28.3°Cj; 2) method of capture; 3) date and time of landing; 4) estimated
time of death; 5) method of cooling; 6) date and time cooling began; 7) sea and air
temperature if exposure temperatures exceeds 83°F [28.3°Cj; 8) adequacy of ice
during on-board holding" (CFSAN, 2001~.
As noted before, the option to apply the current standard on histamine (i.e., a
histamine limit of 50 ppm) in the HACCP plan does exist; however, this is
seldom practical. If a concentration of 50 ppm of histamine were used as the
critical limit in tuna processing operations, an argument could be made that all
histamine-susceptible fish would have to be tested to ensure compliance with the
HACCP plan. Given the current analytical methods for histamine determination,
this would require excessive time and additional product handling that could
further jeopardize product quality and safety. Even if more rapid or less expen-
sive histamine analytical methods for use in a commercial setting were forth-
coming, the utility of such tests would be limited by the viability of the sampling
plan parameters (number and size of samples) required to obtain statistically
meaningful data. Consequently, in keeping with the preventive character of
HACCP, the processor will customarily choose preventive options that are the
least costly and disruptive to plant operations and will thus avoid after-the-fact
analyses or end-product testing as verification tools for a particular hazard. In the
case of histamine, therefore, processors will typically opt for preventing high
histamine levels through the already described option: control of abusive han-
dling conditions that lead to histamine formation in fish and recording of time
and temperature parameters in the vessel and at the plant. These records can be
further supplemented with sensory screening for early signs of temperature abuse
and evidence of adequate refrigeration. When appropriate, specific analytical
tests are performed as part of HACCP verification; in this case, verification may
include the periodic analysis of histamine concentrations in fish showing signs of
temperature abuse. If the process is under control, the expectation is that such
histamine analyses would indicate levels of less than 50 ppm.
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
The Scientific Basis, Public Health Impact, and
Economic Feasibility of Safety Criteria
HACCP has been acclaimed as an appropriate, science-based, food safety
assurance system by the food science community (IOM, 1991; NRC, 1985a,
1985b), although it has not yet been universally applied in the food industry. For
some groups, implementation of HACCP raises concerns about reduced govern-
ment oversight of food processing. For example, a report issued by the General
Accounting Office (GAO, 2001) suggested that FDA's oversight of seafood firms
did not sufficiently protect consumers against foodborne disease. Despite these
controversies, recent reports suggest that HACCP has played a role in reducing
some of the nation's notifiable foodborne illnesses (CDC,2002~. As described in
Chapters 2 and 4, and because of the many confounding factors, a relationship
between HACCP implementation and reduction of illness attributable to specific
food groups cannot be fully established from the available data. However,
HACCP has had a very distinct impact on the seafood industry, primarily through
enhanced awareness and understanding of potential seafood safety hazards from
production and processing through preparation and consumption. Since enact-
ment of the seafood HACCP rule, extensive education and training programs for
industry personnel have been made available through the Seafood HACCP Alli-
ance (SHA, 2001) and other programs. This training has been among the most
beneficial developments in assisting industry managers to recognize food safety
as an integral aspect of their operations in promoting change (Gall, 1999~. A
recent FDA progress report for 2002 reveals that the continuing increase in
compliance with seafood HACCP programs has increased the margins of safety
for American consumers, and that areas of concern are better identified for fur-
ther government oversight and for emphasis by education programs (Office of
Seafood, 2002~.
Further benefits from mandatory HACCP will depend not only on continuing
education, but also on continuing technical innovations. An example that clearly
illustrates this point is the attempt to reduce illness caused by consumption of raw
oysters. Despite the impact of HACCP, foodborne illness from consumption of
raw oysters remains a major and serious seafood safety concern. The principal
culprit is the pathogenic bacterium V. vulnificus. Infections caused by this micro-
organism are relatively rare (approximately 40 reported cases of primary septice-
mia per year) and usually involve consumers with preexisting liver diseases or
immunodeficient conditions, but the fatality rate is high approximately 50 per-
cent of total reported cases (Mead et al., 1999; Personal communication,
M. Glatzer, FDA, December 2002~. The oyster industry and the respective regu-
latory authorities, working through the Interstate Shellfish Sanitation Conference
(ISSC), have determined that in addition to consumer education programs, alter-
native processing technologies such as high hydrostatic pressure are needed to
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CONTROLS FOR HAZARDS IN SEAFOOD
189
reduce the recurrent illnesses due to V. vulnificus and the related species
V. parahaemolyticus (ISSC, 2002a).
The ISSC is modeled after the Interstate Milk Shippers Conference, which
allows participation of state and federal regulatory authorities as well as con-
sumer and industry representatives. The combined expertise and interests of the
ISCC participants result in a unique approach, detailed in their Model Ordinance
for oyster processing. Among other requirements, this Model Ordinance requires
implementation of new postharvest treatments that hopefully will progressively
reduce the average annual reported illnesses attributed to raw oysters (ISSC,
2002a). The reduction goals, 40 percent by 2005 and 60 percent by 2007, were
considered reasonable based on the decisions of the ISSC committees and board,
which involved industry and state and federal agencies. Certain states that do not
meet the required reductions in V. vulnificus illnesses stipulated in a mandated
schedule of annual declines face regulatory consequences that include reduced
production and seasonal closure of harvestable waters (Table 5.1~.
This unique approach requires adequate industry performance without man-
dating a specific process or performance standard, but by establishing a public
health objective. The flexibility of this approach reflects a regulatory shift from
establishing a specific standard to requiring that processors choose and validate
technologies appropriate to their specific operations. In fact, their choice of strat-
egy must result in a measurable and improved performance through an increase
TABLE 5.1 Abbreviated Table of Compliance for Source States as Specified
in the Interstate Shellfish Sanitation Conference's Vibrio vulnificus
Management Plan
Deadline Postharvest Treatmenta illness Reductionsb
December 2004 25% capacity
2005-2006 40% (average)
December 2006 50% capacity
2007-2008 60% (average)
>2008 If the 60% illness reduction rate is not collectively achieved by 2008,
additional controls can be imposed including harvest restrictions or
closures relative to water temperatures and special labels designating
product to be shucked by a certified oyster dealer.
a Postharvest treatment "capacity" will be based on all oysters intended for raw, half-shelled market
during the months of May through September harvested from source states, to include the capacity of
all operational plants and the capacity of plants under construction.
b illness reductions will be based on the average illnesses rate for years 1995-1999 of 0.306/million
persons, using data from California, Florida, Louisiana, and Texas. Adjustments in methodology can
be adopted based on further reviews.
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
in the capacity to implement processing alternatives and through a reduction in
illnesses. The capacity is defined as the actual documented ability to perform in
terms of having appropriate procedures and facilities for the implementation of a
particular processing alternative to reduce V. vulnificus in raw oysters. The reduc-
tion in illnesses, in turn, is determined using an annual average based on reported
illnesses. This is a unique and challenging approach that focuses on encouraging
innovation within a mandated HACCP format.
In the absence of an initial risk assessment, FDA and state regulatory agencies
have used a nondetectable level (i.e., essentially zero tolerance) as the benchmark
for performance (performance standard) for V. vulnificus in oysters intended for
raw consumption (ISSC, 2002b). This measure currently recognizes the fact that
some postharvest treatments can be applied to raw oysters for food safety pur-
poses. Oysters thus treated may not only be exempt from a public advisory or
warning statement, but may also be accompanied with a product declaration such
as "processed for added safety" (ISSC,2002b). The decision to allow or mandate
the use of specific product labels or statements rests with individual state authori-
ties. In time, use of recent Vibrio risk assessments (FAO, 2001; FAD/WHO,
2002) might support the establishment of science-based microbiological perfor-
mance standards for V. vulnificus that ensure a reasonable level of public health
protection while allowing flexibility and innovation in the application of post-
harvest treatments. For example, a risk assessment may conclude that the use of
treatments resulting in levels and types of V. vulnificus equivalent to those found
in oysters during the less problematic winter season reduces this hazard to a
tolerable level of risk.
As another alternative to zero tolerance, FDA may consider use of risk
assessments to establish food safety objectives that specify the level of this hazard
at the point of consumption; however, as discussed extensively in Chapter 3, the
use of food safety objectives is a new concept that has not been fully explored
and, in some cases, may encounter opposition.
One of the attractive elements of the current HACCP-based system is the
increased involvement of industry in determining appropriate food safety control
strategies for hazards associated with specific commodities and processes. While
there is opportunity for a greater level of industry participation, most seafood
processors still request advice from FDA to direct their decisions and practice.
Given the diversity within the seafood industry, FDA determined that specific
guidance would be necessary to assist industry to productively focus its HACCP
plan development and implementation efforts. Anticipating this need, FDA issued
a special guide, the Fish and Fisheries Products Hazards and Control Guide,
commonly referred to as "the Guide," to help implement HACCP in the seafood
industry (CFSAN,2001~. The Guide contains all FDA performance standards for
food safety that are relevant to seafood, as well as guidance in process controls
for seafood-borne safety hazards.
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CONTROLS FOR HAZARDS IN SEAFOOD
191
The Guide was complemented with a national education program, the Sea-
food HACCP Alliance, which involved academic and regulatory expertise in
every state, plus numerous international training efforts based on a cadre of
qualified trainers (SHA, 2001~. This Alliance also developed a "Compendium of
Fish and Fishery Processes, Hazards, and Controls" that can be accessed via the
Internet for detailed information on HACCP programs for various seafood com-
modities, processes, and hazards (SHA, 1997~.
The Guide (CFSAN, 2001) provides recommendations for identifying CCPs,
setting critical limits, monitoring CCPs, and setting corrective actions for various
seafood species and processes. The Guide is a significant and innovative contri-
bution that benefits field inspectors, the seafood industry, and consumers. How-
ever, in many cases, in the absence of other guidance, the recommendations made
in the Guide are interpreted by industry and field inspectors as legal require-
ments, despite the fact that the introduction in the Guide specifically states, "The
controls and practices provided in this guidance are recommendations and guid-
ance to the fish and fishery products industry. This guidance provides informa-
tion that would likely result in a HACCP plan that is acceptable to FDA. However,
it is not a binding set of requirements" (CFSAN, 2001~.
The recommendations and general guidance provided by the Guide (in addi-
tion to established and specified standards) do not limit its utility and impact,
except in some instances when the scientific basis for the recommendations con-
tained therein is not readily evident. For example, FDA recommendations to use
packaging film with elevated oxygen transmission rates (i.e., breathable film) to
avert potential germination and growth of C. botulinum in reduced-oxygen pack-
aging of fresh, refrigerated fishery products may be based on the best currently
available science (CFSAN, 2001~. However, the description of and accessibility
to such packaging materials is not readily evident or well communicated.
Likewise, the Guide does not consider the commercial and regulatory impli-
cations of some of the recommendations it contains. For example, in some cases,
while the recommendations for recording the details on harvesting conditions,
such as time of fish death and duration of handling until iced storage, are science-
based (CFSAN, 2001), documenting these details can pose impractical situations
for the fishermen. In another example, avoidance of potentially toxic fish is based
on excluding designated ciguatoxic-prone waters. (Certain tropical reef waters
support food chains that progressively accumulate toxins generated by plankton
along the food chain; large predator fish at the top of the food chain, in turn,
become toxic to humans.) While this approach appears reasonable and scientifi-
cally valid, designated waters are often not properly mapped, and many fish are
highly mobile so that geographic limits may be meaningless. Such problems do
not indicate a weakness in the regulatory approach, but rather a need for continu-
ous attention to advance and improve the Guide for use by both the inspectors and
the commercial sector.
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
The committee recognizes that the Guide is an innovative and useful docu-
ment that effectively assists seafood processors with the development of their
HACCP plans. To improve its utility, the committee recommends that FDA
consider introducing a more transparent and collaborative process (i.e., one that
allows routine and structured involvement by the respective users and beneficia-
ries) in further developing the Guide. In keeping with its recommendations about
flexibility of the regulatory process made in Chapter 3, the committee further
recommends that the progress, utility, and impact of the Guide be enhanced
through the addition of programs and actions to better communicate relevant
changes in science, commerce, and public health objectives and to facilitate their
incorporation into the Guide.
In addition, the committee recommends that general guidance for all prod-
ucts and processes in the Guide be complemented by FDA with more transparent
and detailed scientific justification, citing reasons, sources, and limitations for the
respective seafood safety criteria, in an accessible format. The intent should be to
offer explanations that can support decisions in accordance with the best avail-
able science and to help focus appropriate responses to the needs for scientific
research, technical innovations, and modifications of regulatory requirements.
To attain the above, and in accordance with the Federal Advisory Committee
Act, the committee further recommends that FDA appoint a Hazards and Con-
trols Guide Advisory Committee that has balanced and qualified representation
from third-party expertise. This committee should routinely convene to critique
the Guide and prepare submissions for changes and interpretations based on
current science and commercial practices, and suggest priorities for scientific,
commercial, and regulatory attention.
When situations involving questionable seafood safety issues have emerged,
some processors have sought assistance from a third party or processing authority
to help validate or verify specific seafood-processing methods or variances from
traditional methods. The term "processing authority" may refer to private con-
sultants, academics, or other experts. However, there are no current FDA guide-
lines for establishing the credentials of processing authorities, or for conducting
process validations or verifications required for a HACCP plan to be accepted by
FDA. In particular, the validation of modern, rapid microbiological methods and
the design of appropriate sampling plans need adequate FDA guidance.
The committee recognizes that the use of processing authorities is consistent
with the seafood HACCP rule (FDA, 1995~. However, the committee recom-
mends that the issues of expert capability and process confidentiality be further
addressed by FDA in the light of food safety considerations. A transparent and
structured protocol must also be developed by FDA to guide process validations.
This protocol must address criteria for distinguishing the creditability of process-
ing authorities, sampling plans, experimental designs, and appropriate method-
ologies. Validation and verification guidelines, including recommendations for
adequate analytical methods and sampling plans, should accompany the recom-
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CONTROLS FOR HAZARDS IN SEAFOOD
193
mended controls in the Guide. Similarly, a regulatory protocol is necessary to
recognize the application of analytical methodologies such as new rapid test
procedures that can be utilized in process validation and in routine verification.
In addition, the committee recommends more timely and continuous com-
munications to ensure awareness, understanding, and consistent application of
the Guide. The intent of this recommendation is broad and includes FDA's
intraprogram activities, state and federal partnerships, individual firms, and the
responsible authorities in countries exporting to the United States. Efforts to
enhance communications should include any reports and recommendations from
the recommended Hazards and Controls Guide Advisory Committee.
The magnitude of concerns about current HACCP governance for seafood
safety is further compounded in international commerce. The regulatory response
to the volume and diversity of seafood trade could set the tone for international
commerce and regulation of other foods. FDA's new approach regarding inter-
national commerce considers all seafood processors equal and challenges each
nation to demonstrate the capability of its respective authority for seafood safety.
A similar approach has been introduced by Canada (CFIA, 2002) and the Euro-
pean Union (EEC, 1991~. Although these regulations require recognition of "com-
petent authorities" and responsible criteria and standards, some nations' efforts to
scrutinize other nations' competence and commercial performance appear to be
defensive and have been perceived as trade barriers (sham Prasidh, 1999~. The
Codex Alimentarius offers some cooperation among national authorities, but its
recommendations often lack the necessary details to address the issues raised by
specific countries or products. As mentioned earlier, this situation must be
addressed by FDA in anticipation of the increasing U.S. dependence on seafood
imports.
The committee recommends that FDA give immediate attention to the appli-
cation of the Guide to ensure food safety equivalence in international seafood
commerce. Moreover, the committee recommends that FDA clarify the intent of
the Guide and its content to U.S. trading partners. In addition, the committee
recognizes that screening limited quantities of seafood products at points of entry
is not consistent with the preventive concept of HACCP; therefore, FDA should
establish more regulatory oversight prior to receiving foreign seafood products at
points of entry into the United States.
Also, with a continuing reliance on a science-based approach, there is a need
for more scientific collaboration among nations and for more extensive sharing of
information on seafood safety issues applicable in the respective nations. The
committee suggests that a scientific program with international participation and
support could incorporate the concerns of the authorities regarding specific
products, so that agreements regarding appropriate seafood safety standards are
reached. This approach could be driven by collaborative research in support of
the Codex Alimentarius. Similar efforts have already been made in the area of
joint Food and Agriculture Organization of the United Nations (FAO)/World
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
Health Organization (WHO) microbiological risk assessments (FAD/WHO,
2002~. The United States, through EPA and FDA, and using the Guide as a
model, could initiate an international seafood safety exchange program. This
international program could include research and training to address common
concerns about such hazards as Salmonella and Listeria in fresh seafood and
methyl mercury tolerances, and develop recommendations for best practices such
as Best Aquaculture Practices. The Best Aquaculture Practices could be similar
to Good Agncultural Practices for produce and other land-based crops (CFSAN,
1998), and consistent with Good Manufactunng Practices. The Best Aquaculture
Practices could be developed collaboratively and could be recognized as the
international prerequisite for the expanding aquaculture production around the
world.
In summary, the committee recognizes that limitations in supply are becom-
ing one of the most significant issues in the world of seafood commerce, and that
trends in the United States reflect a growing dependence on international sources,
particularly with regard to aquaculture products. Regulatory decisions and pnon-
ties to address seafood safety must account for this situation.
Therefore, with an awareness of existing international seafood safety
programs and efforts (e.g., within Codex Alimentanus, FAD/WHO, and others),
the committee recommends that FDA initiate an International Seafood Safety
Exchange Program to foster and generate support for international collaboration
in seafood safety research and training. A common topic for initial consideration
could be the development of Best Aquaculture Practices. The existing FDA Fish
and Fishery Products Hazards and Controls Guide could be used as a proven
format.
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Representative terms from entire chapter:
seafood safety
