US FDA - CFSAN FDA's Evaluation of The Seafood HACCP Program For 2002 - 2003

US FDA/CFSAN FDA's Evaluation of the Seafood HACCP Program for 2002/2003
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CFSAN/Office of Seafood
May 13, 2005
FDA's Evaluation of the

Seafood HACCP Program for
Fiscal Years 2002/2003
SUMMARY
This evaluation covers the status of domestic and international seafood processors and importers in Fiscal Years
2002 and 2003 in operating preventive controls under FDA's Hazard Analysis Critical Control Point (HACCP)
Program. These Fiscal Years essentially represent the fifth and sixth years of the seafood HACCP program.
This is the third such evaluation. The first, issued on December 8, 2000, evaluated progress through the first two
years of the program, calendar years 1998 and 1999. The second issued on September 30, 2002, evaluated
program progress through the third and fourth years, fiscal years 2000 and 2001.
Program Objective
HACCP is a science-based system of preventive controls for food safety that commercial seafood processors
develop and operate to identify potential problems and keep them from occurring. The FDA HACCP program
was designed to increase the margin of safety that U.S. consumers already enjoyed and to reduce those illnesses
that do occur to the lowest possible levels.
Compliance Programs Objective

The objective of these Compliance Programs is to ensure a safe and wholesome fish and fishery products supply
in the U.S., by ensuring compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its regulations
by: domestic establishments involved in the production, storage and distribution of fish and fishery products;
foreign fish and fishery processors that export their products to the U. S.; and U.S. importers of fish and fishery
products.
Domestic Seafood Products Compliance Program Background

The Domestic Seafood Products Compliance Program (CP7303.842) provides regulatory coverage of fish and
fishery products to ensure a safe and wholesome domestic seafood supply. It includes policy and procedural
http://www.cfsan.fda.gov/~comm/seaeval3.html (1 of 17)12/20/2006 10:43:52 AM

guidance for ensuring compliance by domestic processors that distribute fish and fishery products in interstate
commerce and foreign fish and fishery processors that export product to the United States (U.S.). Following the
promulgation of 21CFR Part 123, "Procedures for the Safe and Sanitary Processing and Importing of Fish and
Fishery Products" Final Rule (the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation),
the Agency is now performing HACCP compliance inspections of domestic and foreign fish and fishery
products processing facilities. These inspections ensure that fish and fishery products processors implement a
system of preventive controls, in addition to ensuring compliance with more traditional regulatory requirements,
such as Current Good Manufacturing Practice Regulations.
CP7303.842 provides additional coverage to products covered under the Molluscan Shellfish Evaluation
Program, CP7318.004, (i.e., oysters, mussels, clams and whole or roe-on scallops) and the Domestic Acidified
and Low Acid Canned Foods Compliance Program (LACF), CP7303.803A, (i.e., hermetically sealed low-acid
canned fish and fishery products and acidified fish and fishery products).
Imported Seafood Products Compliance Program Background

The Imported Seafood Products Compliance Program (CP 7303.844) provides regulatory coverage of imported
fish and fishery products to ensure a safe and wholesome supply of seafood entering the U.S. Historically, FDA
has controlled imports by reviewing customs entries, conducting field exams, collecting samples for laboratory
analysis, and placing products with a history of problems on detention without physical examination. This
program addresses the control of pathogens, filth, parasites, decomposition, animal drugs, bio-toxins, and illegal
food and color additives in imported fish and fishery products. These efforts continue under the present
program, and are an important component of the import control strategy.
With the promulgation of the Seafood HACCP regulation, there is now a second component of the import
control strategy. Under the HACCP system of controls the importer and the foreign processor share the
responsibility for safety. Foreign processors that ship fish or fishery products to the U.S. must operate in
conformance with the seafood HACCP Regulations. In addition importers are required to take positive steps to
verify that their imported products are obtained from foreign processors that comply with the Seafood HACCP
Regulation. This Compliance Program provides guidance for ensuring that importers have verified that the
products they offer for entry were obtained from foreign processors that are in compliance with the requirements
of the Seafood HACCP Regulation.
DISCUSSION
On the domestic side, this evaluation covers implementation of the program by U.S. fish and fishery products
processors, as observed during regulatory inspections by FDA and some states operating under contract or
partnership agreements with FDA. It should be noted that the data included in the tables in this report are based
on the number of inspections actually completed and not the total number of firms in the FDA inventory. Not all
firms are inspected annually; decisions on which firms to inspect are based on level of risk and compliance
history. This report also includes information about HACCP implementation by domestic processors of raw
molluscan shellfish, as observed during audits by FDA of inspections performed by state regulatory authorities
under the National Shellfish Sanitation Program.
On the international side, this report reviews the status of HACCP implementation by 176 processors in 20
countries that were visited by FDA inspectors during 2002 and 2003. It also covers progress by U.S. importers

of foreign fish and fishery products in ensuring that their foreign suppliers are complying with U.S. HACCP
requirements.
Like the previous evaluations, this one lists in tables the most significant elements of the program and provides
the percentage of processors in each program year that succeeded in accomplishing each of these elements. The
accompanying narrative addresses specific aspects of the data in the tables, including noteworthy trends and
issues that are emerging, continuing, or reversing since the previous evaluation.
Firms are classified by FDA as "no action indicated" (NAI), "voluntary action indicated" (VAI) or "official
action indicated" (OAI) as a result of the most recent inspection. Traditionally FDA considers a firm "in
compliance" when the most recent inspection was classified NAI or VAI.
The percentage of firms inspected classified by FDA as NAI (signifying that no objectionable conditions were
found during the inspection) increased each year before 2002. Conversely, the number of firms inspected
classified VAI (signifying that objectionable conditions were found but if corrected in a timely manner would
not warrant regulatory or administrative action) decreased each of these years (See Figure 1). The inverse
relationship between the NAI and VAI rate changes meant that many VAI firms were correcting their
deficiencies voluntarily. In FY2002 and 2003, however, there was a reversal of this trend. The NAI percentage
decreased somewhat from its peak in FY2001, while the VAI percentage increased from its low point in FY
2001. This phenomenon does not mean that firms are no longer making voluntary corrections between one
inspection and the next, but that the percentage of the inspected firms doing so has dropped somewhat. This
trend could be accounted for by the fact that FDA no longer inspected 100% of the domestic seafood firms,
forcing the Agency to concentrate its inspectional resources on the higher risk (i.e. typically more complex) and
previously noncompliant firms, thereby skewing the data. FDA will continue to monitor the situation and further
study will be warranted if the trend continues.
The OAI classification (signifying that objectionable conditions were found that warrant regulatory or
administrative action) has consistently been the smallest of the three percentages. The last two years reflects a
decrease over the previous three years, indicating that some firms have made the needed corrections as a result
of past regulatory action or because they otherwise recognized the need to do so.
Based on FDA's historical classification system, in FY 2003 approximately 91% of firms were "in
compliance" (NAI or VAI). This is a significant increase over the 85% compliance rate of 2001, especially if, as
suggested above, FDA's inspectional coverage has shifted to potentially more problematic firms.
Overall, the domestic industry continues to make progress in implementing HACCP systems, but the rate of
progress has tapered off compared to the early years of the program. Of eleven significant HACCP program
elements, eight showed improvement during the FY 2002-2003 time period over the FY 2000-2001 time period,
three showed a slight decrease from one time period to the next, and one remained the same. For those that
showed some improvement, the average increase was 2.6%; while for those that showed some decrease, the
average drop was 1.7%. Collectively, for firms with HACCP plans the average increase on the nine individual
program elements that relate to plan content and implementation from one time period to the next was 1%,
resulting in a combined average success rate on each individual element of 84% (See Table 1).
Since the first evaluation, FDA has targeted inspections and education efforts at those industry segments that
have lagged behind in implementation. In FY2002 and 2003 FDA prioritized firms for inspections and training
that process smoked fishery products and scombroid species, (i.e., those species of fish that can form
scombrotoxin if time/temperature abused), because these segments lagged behind others in FY2000 and 2001

(See Table 2). This resulted in smoked product firms showing progress on all nine significant HACCP plan
content and implementation elements from FY2001 to 2003. Also firms that process scombroid fish species
progressed in seven of the nine elements.
Processors of raw molluscan shellfish showed improvement in five of seven elements for which data is available
for that commodity between FY2001 and 2003 (See Table 3). Raw molluscan shellfish processors out-
performed processors of other high risk fishery products in six of the seven elements. However, in identification
of critical limits the shellfish industry lagged significantly behind other high-risk industry segments.
Data on foreign processors that ship seafood to the United States are obtained during FDA inspection trips to
foreign countries. As in previous years, the focus has been on processors in developing countries that would not
be expected to be subject to the same kind of domestic HACCP requirements as their U.S. counterparts. Foreign
inspections also tend to target high risk processors, for which compliance is generally more challenging. In all
but one element foreign processor percentages were lower in FY2003 than 2001. However, comparison from
year to year is difficult, because the foreign data involves visits to different countries and different processors
from year to year, rather than return visits to the same processors.
Importers of foreign fish and fishery products into the United States are obligated to take "affirmative steps" to
determine that their foreign suppliers are complying with U.S. requirements. Seafood importers made progress
on all three program elements that relate to them between FY2000 and 2001; however, that was not the case
between FY2001 and 2003. In fact, the most significant element, implementation and documentation of
affirmative steps, dropped by ten percentage points between FY2001 and 2003. As with foreign processors only
a small percentage of the U.S. seafood importers are inspected each year and so comparison between years may
not be appropriate. Nonetheless, as was the case in FY2001, most percentages for 2003 show that importers as a
whole still have much progress left to make. Low inspection frequency is a likely contributing factor.
RESULTS
Domestic Industry Progress
(a) "Compliance Rate"
The attached graph (Figure 1) shows the trends in the percent of inspections conducted each year from FY1998
through FY2003 that were assigned to each of the three FDA inspectional classifications. These classifications
are: "No Action Indicated" (NAI), signifying that no objectionable conditions were found during the inspection;
"Voluntary Action Indicated" (VAI), signifying that objectionable conditions were found but if corrected in a
timely manner would not warrant regulatory or administrative action; and, "Official Action Indicated" (OAI),
signifying that objectionable conditions were found that warrant regulatory or administrative action. In the
HACCP program, a firm that is classified OAI is generally one for which FDA has documented significant
deviations from the regulation, and that has failed to take appropriate "voluntary" action. Historically, firms
classified NAI and VAI have been classified "in compliance."
For the first four years of HACCP implementation, the percentage of NAI firms increased each year and the
percentage of VAI firms decreased, indicating that many of the VAI firms voluntarily corrected their
deficiencies. During the first three years of the program, VAI constituted the largest inspectional classification.
In FY2001 that distribution shifted to NAI; however, in FY2002 the distribution shifted back and VAI returned

as the largest classification. This most recent trend could be accounted for by the fact that FDA no longer
inspected 100% of the domestic seafood firms, forcing the Agency to concentrate its inspectional resources on
the higher risk (i.e. typically more complex) and previously noncompliant firms, thereby skewing the data. FDA
will continue to monitor the situation and further study will be warranted if the trend continues.
The OAI classification has consistently been the smallest, but increased each of the first four years as some
firms failed the opportunity to make needed corrections. In the FY 2002-2003 time frame the percentage of OAI
firms dropped significantly from the percentages in the previous three years. This drop indicates that some OAI
firms have corrected their deficiencies as a result of past regulatory action or because they otherwise recognized
the need to do so. As Figure 1 indicates, the overall "compliance" rate (NAI plus VAI) for FY2003 was about 91
percent.
FIGURE 1
(b) Success on Individual Elements: Domestic Industry Overall

As shown by the data in Table 1, a significant majority of inspected processors continue to be successful on
most of the individual elements of the program. For those firms that had a plan, the overall average rate of
success in implementing individual HACCP program elements increased slightly from 83% in FY2001 to 84%
in FY2003 (line 14). In other words, for any of nine HACCP program elements involving the HACCP plan and
its implementation, the average likelihood that a processor fully succeeded in implementing it was 84% in
FY2003.
There have been some significant changes in industry success with individual program elements from FY2001
to FY2003. Inspected firms that do not need a HACCP plan (because no food safety hazards were reasonably
likely to occur) decreased from 31% of firms in FY2001 to 26% in FY2003 (line 2). This trend could be
accounted for by the fact that FDA no longer inspected 100% of the domestic seafood firms, forcing the Agency
to concentrate its inspectional resources on the higher risk (i.e. typically more complex) and previously
noncompliant firms, thereby skewing the data.
As was the case in FY 2001, in FY2003 the percentage of inspected firms that needed a HACCP plan but did
not have one (line 3) is quite high. The percentage increased slightly from 15% in FY2001 to 18% in FY 2003.
This problem persists despite the fact that this program element was prioritized for FDA field regulatory follow-
up. FDA is investigating the causes of this trend. It may be that many of these firms are warehouses that had not
been previously inspected. A significant number of additional warehouses have been shifted recently to FDA's
seafood HACCP inventory for inspection planning purposes. Firms without required HACCP plans were
prioritized for follow-up inspections in FY2004.
The adequate identification of critical limits by processors (line 6) has progressed steadily since FY1998 and
increased 5% between FY2001 and 2003. This steady trend upward is encouraging because the establishment of
adequate critical limits represents some of the most sophisticated scientific thinking associated with the
development of a HACCP system (i.e., involving the performance of cook studies, research, etc.).
Steady progress has been made in industry adoption of adequate sanitation controls and HACCP-type sanitation
monitoring and record keeping for sanitation (line15). Although the 54% success rate appears low, this item
represents an extremely strict standard. Any sanitation infraction or sanitation monitoring deficiency would
cause the firm to be marked deficient for this item. The 54% rate represents better than 100% improvement from
the baseline year of FY1998.
(c) Success on Individual Elements: Specific Domestic Industry Sectors
Table 2 presents the seafood HACCP inspection data sorted by industry segment and by food safety hazard. The
data in Table 2 differ from those in Table 1 in that they show success by inspected processors in controlling the
single hazard identified in the particular line item in the table. By contrast, Table 1 shows the success of
inspected processors in controlling all hazards that might be relevant to their operations. For that reason, it is
difficult to compare an industry sector's performance in Table 2 to the industry as a whole in Table 1. The better
comparison would be an industry sector's performance in Table 2 against performance by the other industry
sectors in Table 2.
When the data are viewed by industry segment and food safety hazard, the improvements seen in FY2001, in
those segments of the industry to which educational and inspectional activities were refocused in FY2000 to
correct lagging implementation, generally continued in FY2002 and 2003. FDA initiated actions in FY2000 to

address implementation gaps identified in the 1998/1999 report, including increased emphasis on the control of
pathogens by processors of cooked, ready to eat fishery products, breaded and stuffed fishery products, and
smoked fishery products, and control of scombrotoxin by processors of scombroid species. Those actions
continued in FY 2002 and FY 2003, especially for processors of smoked fishery products and scombroid
species. The actions included various industry education initiatives and a focusing of regulatory inspections
toward the problem areas. As an apparent consequence, improvement occurred from FY2001 to 2003 for the
control of pathogens by inspected processors of smoked fishery products and for the control of histamine by
processors of scombroid species. Success by processors of smoked fishery products increased in 8 of 9 elements
by an average of 7%; and for scombroid species success increased in 7 of 9 elements by an average of 4%.
Notwithstanding the recent progress by the scombroid species processing industry, the Agency continues to
engage in significant activity to encourage further improvements by that sector. Because of concerns by the
industry that FDA's recommended critical limits are impractical for large and long line caught tunas, FDA is
conducting research in this area. The goal of this research is to ensure that FDA's recommendations are as
practical as possible, while still being sufficiently protective of the public health.
However, progress in the control of pathogens in cooked, ready to eat seafood was mixed between FY 2001 and
FY 2003. Success rates for 3 elements improved by an average of 2% and worsened for 5 elements by an
average of 2%.
One industry segment for which success is lagging behind is the aquaculture fish sector, with respect to the
control of aquaculture drugs. In fact success rates are decreasing for this hazard. In FY 2001, FDA first reported
this trend, but could not identify the cause. The trend remains puzzling. However, because of the relatively
small number of aquaculture processors (89 inspected in FY2001, and 78 in FY2003), the data are subject to
greater variability and uncertainty than data for other segments. FDA will continue to analyze the data for
explanations in the trend and take corrective measures as necessary to reverse it.
Success rates also remained relatively low relative for the control of pathogens by processors of cured and dried
fishery products. Adequacy of preventive controls by processors of cured fishery products worsened from
FY2001 to 2003 by an average of 5%. Adequacy of these controls by processors of dried fishery products
worsened by an average of 2%. Like aquaculture firms, the numbers of inspected firms in these categories have
been small (64 and 33, respectively in FY2003). Therefore, the percentages are quite volatile from year to year
and may be misleading.
In FY2002 and 2003 problems were mostly related to the implementation of HACCP plans, rather than to the
adequacy of the plans, themselves. In particular, implementation of monitoring procedures and maintenance of
monitoring records were the most problematic. In past evaluations FDA discussed how it expected that in the
early stages of the program, industry problems would focus on hazard identification and the drafting of adequate
HACCP plans, and then shift toward implementation of those plans. The data suggest that this shift is occurring.
TABLE 1
Domestic Industry Progress - Focusing on Program Elements
Adoption of HACCP and Sanitation Preventive Controls by Regulatory Provision (1998 - 2003)
Mandatory HACCP/Sanitation Provision 1998 1999 2000 2001 2002 2003
(%) (%) (%) (%) (%) (%)

HACCP plan present when needed or HACCP plan not

1 79 84 88 88 90 91
needed - all firms inspected
2 No HACCP plan needed - all firms inspected 32 30 30 32 31 26
3 HACCP plan present when needed - all firms that need a plan 68 78 82 85 82 82
Adequate identification of hazards in plan - all firms with
4 66 83 86 86 89 87
plan
Adequate identification of Critical Control Points in plan - all
5 ND 86 81 84 85 86
firms with plan
Adequate identification of Critical Limits in plan - all firms
6 67 66 75 77 80 82
with plan
Adequate identification of monitoring procedures in plan - all
7 67 76 78 79 77 79
firms with plan
Adequate identification of corrective actions in plan - all
8 76 83 86 87 91 89
firms with plan
9 Meet training requirement - all firms inspected 84 85 86 85 86 89
Adequate implementation of HACCP monitoring procedures
10 72 78 77 77 77 76
- all firms with a plan
11 Adequate HACCP monitoring records - all firms with a plan 71 69 68 70 71 73
Adequate corrective actions taken after critical limit
12 deviations or no corrective actions needed - all firms with a 81 86 92 91 93 92
plan
Adequate corrective action records when corrective actions
13 72 88 95 95 95 94
taken or no corrective actions needed - all firms with a plan
Overall average of items 4-8, and 10-13, covering success with
14 9 individual plan and implementation elements-- all firms 64 79 82 83 84 84
with a plan
Adequate sanitation controls (All GMPs and all sanitation
15 21 34 47 50 51 54
monitoring & record keeping) - all firms inspected
16 No significant GMP violations - all firms inspected 48 56 65 67 66 67
Adequate HACCP-type sanitation monitoring - all firms
17 44 77 76 77 77 78
inspected
18 Adequate sanitation monitoring records - all firms inspected 43 58 69 74 71 79
Adequate sanitation corrections taken when sanitation
19 deficiencies noted or no sanitation corrections needed - all ND 94 91 92 91 92
firms inspected
Adequate sanitation correction records when sanitation
20 corrections taken or no sanitation corrections needed - all 72 89 87 92 91 92
firms inspected

TABLE 2
Domestic Industry Progress - Focusing on Program Elements
Adoption of HACCP and Sanitation Preventive Controls by Regulatory Provision (2002 - 2003)
Hazard Adequate
Plans Hazards CCP(s) CL(s) Monitoring CA Monitoring Proper Proper
CA Properly
and Properly Properly Properly Properly Properly Properly Monitoring CA
Implemented
Implement Identified Identified Identified Identified Identified Implemented Records Records
Overall
02 03 02 03 02 03 02 03 02 03 02 03 02 03 02 03 02 03 02 03
Pathogens-all
70 71
firms with a plan
Cooked ready-to-
87 90 85 86 80 81 75 79 91 91 79 75 70 71 91 91 94 94
eat firms
Smoked seafood
81 91 85 92 72 77 71 74 91 92 72 76 61 69 90 91 94 94
firms
Cured seafood
87 82 72 88 72 79 66 79 94 88 78 82 69 70 94 100 97 100
firms
Dried seafood
83 100 83 91 74 91 78 86 91 100 78 91 65 95 91 100 100 95
firms
Breaded/Stuffed
86 95 89 92 87 86 85 90 92 94 87 86 84 87 97 97 99 98
seafood firms
Parasites-all
98 98
firms with a plan
Cured seafood
94 94 97 94 97 91 97 100 97 97 97 94 100 100 100 100 100 100
firms
Nonscombroid
finfish species 98 98 98 97 98 99 98 98 100 99 98 99 98 97 99 99 99 99
firms
Ciguatera-all
100 100
firms with a plan
Nonscombroid
finfish species 99 99 99 98 98 98 98 98 99 98 98 100 98 100 99 100 99 100
firms
Histamine-all
86 84
firms with a plan
Scombroid
96 95 90 91 83 85 81 80 92 89 75 75 70 73 95 93 96 96
species firms
Environmental
chemicals-all 97 96
firms with a plan
Aquacultured
95 91 98 96 98 93 91 98 98 93 95 91 98 91 100 96 100 98
fish firms
Crustacean firms 100 99 100 99 100 99 100 99 100 99 99 98 98 98 99 99 99 99
Nonscromboid
98 96 96 96 96 96 94 96 98 97 94 97 93 95 98 98 98 98
finfish firms
Aquacultured
drugs-all firms 99 98
with a plan
Acquatulured
95 83 98 91 98 85 95 85 95 89 91 87 93 87 100 93 100 94
fish firms

Food additives-
all firms with a 95 98
plan
Crustacean firms 98 99 98 99 98 99 97 99 100 100 94 96 93 98 98 100 99 100
Physical hazards-
all firms with a 97 98
plan
Mixed fishery
93 97 94 98 97 99 96 99 99 99 99 99 100 99 99 99 99 99
products firms
Breaded/Stuffed
95 100 98 100 97 99 97 99 96 100 98 100 98 98 100 100 100 99
seafood firms
Domestic Molluscan Shellfish

Industry Progress
Tables 1 and 2 do not contain data for processors of raw molluscan shellfish (i.e., oysters, clams, mussels). That
is because State shellfish control authorities inspect these processors under the National Shellfish Sanitation
Program (NSSP) and the results are not compiled into FDA's National Seafood HACCP Inspection Database.
The NSSP is a Federal/State cooperative arrangement for the regulation of the raw molluscan shellfish industry.
State regulatory authorities inspect these processors and FDA audits each State regulatory program. As part of
this audit, each year FDA shellfish specialists accompany State inspectors on a number of their inspections. A
total of 180 accompanied inspections were performed in FY2003.
During these inspections, the FDA shellfish specialists completed an inspection form that contains data similar
to that contained in the National Seafood HACCP Inspection Database. Table 3 compares the data collected in
this manner in FY2001 and 2003, and also compares the data for the molluscan shellfish industry in FY2003
against two other industry segments with similarly elevated food safety risks, the cooked ready-to-eat segment
and the scombroid seafood segment, in the same year. Like the data in Table 1, the data in Table 3 are organized
in a way that helps FDA identify program elements that may be the source of performance problems so that
regulatory attention might be directed toward those aspects of the program.
On average, molluscan shellfish processors performed better in the development and implementation of HACCP
plans than did the other high risk processors to which they were compared. Additionally, improvement was seen
between FY2001 and 2003 in 5 of the 7 programs elements examined. The superior performance of molluscan
shellfish processors in plan development can likely be accounted for, at least in part, by the detailed, prescriptive
nature of the NSSP, to which these processors are obliged to comply. In particular, the NSSP Model Ordinance
provides many of the HACCP plan elements for processors of molluscan shellfish, including some mandatory
critical limits. Also noteworthy is the fact that molluscan shellfish processors are inspected by State Shellfish
Control Authorities between two and four times per year (depending upon the nature of their business). It is
likely that this high level of regulatory contact has helped accelerate the plan development and implementation
process.

On the other hand, on average, processors of molluscan shellfish performed slightly worse in identification of
critical limits and taking appropriate corrective action than did the other processors to which they were
compared. It is worth noting that the processors covered under the "accompanied" inspections, as described
above, are only a representative sampling of the entire industry segment and tend to differ from year to year.
Consequently, comparisons from year to year carry some inherent uncertainty.
TABLE 3
Domestic Molluscan Shellfish Industry Progress - Focusing on Program Elements
Adoption of HACCP Preventive Controls by Regulatory Provision
Cooked,
Mandatory HACCP/ Molluscan Molluscan Scombroid Species
Ready-to-Eat
Sanitation Provision Shellfish 2001 Shellfish 2003 2003
2003
Adequate identification of
all relevant hazards in 96 97 90 95
plan - all firms with a plan
Critical Control Points (all
96 96 86 91
relevant hazards) in plan -
all firms with a plan
Critical Limits (all
82 78 81 85
monitoring procedures (all
81 93 79 80
Adequate implementation
of HACCP monitoring
procedures (all relevant 90 93 75 75
hazards) - all firms with a
plan
Adequate HACCP
monit91oring records (all
90 95 71 73
relevant hazards) - all
firms with a plan
Adequate corrective
actions taken after critical
limit deviations or no
93 84 89 93
corrective actions needed
(all relevant hazards) - all
firms with a plan

Foreign Industry Progress
FDA's seafood HACCP program applies to imported as well as domestically produced seafood. The majority of
all seafood consumed in the United States is imported, from about 159 countries. A number of these countries
have advanced regulatory systems for seafood, while others do not. FDA's traditional strategy is to review
entries of products being offered for import into the U.S., and on that basis, to select products for physical
examination at ports-of-entry. The examination is primarily directed toward determining whether the product
contains substances that would cause it to be adulterated under U.S. law. This examination would not
necessarily reveal whether the products were produced under HACCP-type preventive controls in the country of
origin. And, while it could be inferred that adulterated products were not processed under fully functioning
HACCP systems, the specific HACCP deficiency probably could not be identified without more information.
Consequently, FDA has developed new strategies to augment port-of-entry examination. The first strategy is a
requirement in the Seafood HACCP Regulation that U.S. importers take "affirmative steps" to help ensure that
imported seafood products have been processed in accordance with the U.S. HACCP requirements. Affirmative
steps may be basic, threshold indicators of performance, such as obtaining copies of foreign processors' HACCP
plans and records. Importers are not expected to be surrogate regulatory agencies. Nonetheless, the "affirmative
steps" requirement was novel and, FDA anticipated that it would take some time to be fully understood and
implemented by the entire importing community. FDA now inspects importers at their places of business to
determine whether they are meeting their "affirmative steps" obligation. That topic is covered in the next section
of this report.
The second strategy involves a significant increase in foreign regulatory inspections by FDA inspectors. So far,
these inspections have been directed towards developing countries that are major exporters of seafood. FDA
chose developing countries because they are less likely to be providing advanced, HACCP-based regulatory
feedback to their own processors than are highly developed countries. Countries with advanced regulatory
systems for seafood are generally implementing and enforcing HACCP-type systems for their products. Most
processors are implementing HACCP but have not perfected it yet. For that reason, education, both for the
industry and the local regulatory agencies, is a major component of these inspection activities.
In FY2002 and 2003, FDA sent inspection teams to eleven and seven countries respectively that are major
exporters of seafood to the United States. The trips had several purposes. First, FDA wished to engage in direct,
in-plant compliance inspections of foreign processors that are subject to U.S. HACCP requirements. Second,
FDA sought to develop contacts and relationships with the competent inspection authorities and industries in
these countries. Third, FDA wished to provide training and educational opportunities to both the industry and
government. During the FY2002 and 2003 visits, 106 and 70 seafood processors, respectively, were inspected
for compliance with U.S. HACCP requirements.
Table 4 provides the results of foreign inspections from 1999 through 2003. In the 1998/1999 and FY2000/2001
evaluation reports FDA attempted to compare results of foreign inspections to those of domestic inspections.

The agency has not done that in FY2002/2003 because there are several important distinctions between U.S. and
foreign inspections performed by FDA that make such comparisons difficult: 1) foreign inspections are
performed on different firms and in different countries from year to year, while domestic inspections are
performed on the same firms; 2) foreign inspections focus on products with an elevated food safety risk, while
domestic inspections cover products across the risk spectrum; 3) foreign inspections tend to focus on firms with
regulatory problems, while such firms make up only a relatively small portion of the those covered
domestically, and 4) foreign inspections are announced months in advance, whereas domestic inspections are
unannounced.
Although foreign seafood processors that ship to the United States are subject to the same U.S. regulatory
requirements as domestic firms, FDA expected that HACCP implementation in developing countries would lag
somewhat behind that in the United States. There were three reasons for this expectation. First, it is more
difficult for processors in developing countries to obtain necessary information in the form of training and
guidance in order to help them understand the principles and requirements involved. Second, as previously
stated, firms in developing countries may not be receiving regulatory feedback on HACCP principles from local
regulatory authorities. Third, local requirements may not be consistent with FDA's HACCP program. FDA's
strategy to help overcome these disadvantages is to continue its foreign inspection program and to continue
working with local regulatory officials to upgrade their understanding and capability. There is no good
substitute for domestic regulatory control and regular, consistent feedback on the adequacy of HACCP systems.
In FY2003 the success percentages on most program elements dropped from previous years. As previously
stated, it is not possible to determine whether this represents an actual decline by foreign processors or the result
of targeting countries and processors that the Agency has identified as having problems. FDA uses information
obtained through inspections of importers and from physical examinations at entry when designing foreign
inspection trips. FDA will continue to target countries and processors with identified problems on future
inspection trips.
TABLE 4
Foreign Producer Progress - Focusing on Program Elements
Adoption of HACCP Preventive Controls by Regulatory Provisions
1999 2000 2001 2003
Mandatory HACCP Provision
Foreign Foreign Foreign Foreign
* 2002-Insufficient Data
(%) (%) (%) (%)
HACCP plan present when needed or no HACCP plan needed -
100 87 86 82
all firms inspected
No HACCP plan needed - all firms inspected 0 13 16 15
HACCP plan present when needed - all firms that needed a plan 100 93 98 67
Adequate identification of all relevant hazards in plan - all firms
50 61 55 73
with a plan
Adequate identification of Critical Control Points (all relevant
50 70 80 73
hazards) in plan - all firms with a plan

Adequate identification of Critical Limits (all relevant hazards) in

53 66 61 60
plan - all firms with a plan
Adequate identification of monitoring procedures (all relevant
36 68 65 64
Adequate identification of corrective actions (all relevant
47 96 94 82
Meet training requirement - all firms inspected 100 100 95 93
Adequate implementation of monitoring procedures (all relevant
39 79 72 71
hazards) - all firms with a plan
Adequate HACCP monitoring records (all relevant hazards) - all
ND 90 91 56
firms with a plan
Adequate corrective actions taken after critical limit deviations or
no corrective actions needed (all relevant hazards) - all firms with ND 82 94 87
a plan
Adequate corrective action records when corrective actions taken
or no corrective actions needed (all relevant hazards) - all firms ND 92 97 89
with a plan
Importer Progress
As mentioned above, importers of seafood into the United States must comply with several special requirements
of the Seafood HACCP Regulation that are designed to ensure that the products they offer for entry are
processed under an acceptable HACCP system. Importers are required to formulate written verification
procedures that include product specifications and one or more "affirmative steps" to help ensure that the
product offered for entry has been processed under HACCP controls. They must also keep and make available
to FDA certain records that document compliance with these requirements. These records are examined during
unannounced inspections of importers by FDA inspectors at the importer's place of business.
Before the seafood HACCP program, FDA did not directly impose requirements on importers or conduct
unannounced inspections of importers, so there was no need to maintain an establishment inventory for
importers of fish and fishery products. Since the advent of seafood HACCP, the agency has been working to
develop such an inventory. FDA's best estimate of the number of seafood importers is 8500 firms. During
FY2002 and 2003 the agency performed 389 and 609 inspections of these businesses, respectively. For each
inspection, the FDA inspector completes a data form to provide detailed information about the inspection to the
National Seafood HACCP Database. The data from these inspections are displayed in Table 5. It is important to
note that, because of the relatively small number of importers inspected each year as compared to the estimated
total number of U.S. fishery products importers, many of the importers inspected even in 2003 were being

inspected for the first time. This factor should be taken into account when attempting to make comparisons
between years.
The above caveat notwithstanding, examination of the data suggests that importers generally made substantial
progress between FY1998 and 2001 in the preparation of written product specifications and written "affirmative
steps," but that this progress has slowed in FY2002 and 2003. On the other hand, importers have made little
progress in actually taking adequate, properly documented affirmative.
Importers of scombroid species have had and continue to have a particularly low success rate. This may be a
result of a lack of understanding by importers of the scombroid hazard and how it can be controlled. The lag in
compliance for importers of scombroid species mirrors the lag for domestic processors of this product.
TABLE 5
Domestic Industry Progress - Focusing on Importers
Special Requirements for Imported Products
1998 1999 2000 2001 2002 2003
Special Requirements for Imported Products
(%) (%) (%) (%) (%) (%)
1 Importers with written verification procedures 34 45 47 52 56 54
2 Adequate written verification procedures/product specification 74 77 87 96 96 97
Adequate affirmative steps accomplished in practice and
3 50 48 55 58 52 48
documented
Affirmative steps accomplished in practice and documented by
4
product category
Scombrotoxic Species 44 36 42 60 41 48
Smoked Fish 29 50 33 50 ID* ID*
Cooked Ready to eat 57 50 40 55 67 62
*ID = Insufficient Data
VERIFICATION SAMPLES
The Domestic Fish and Fishery Products Inspection Compliance Program require FDA Investigators to collect
HACCP verification samples from domestic seafood processors. These samples are used as a means of judging
the overall effectiveness of the HACCP system. The results of these samples enable FDA to make
determinations about the likelihood of the occurrence of particular safety defects in products that are produced
under HACCP preventive controls.

FDA evaluated sample data from FY2002 to include in this report. In FY2002, 480 HACCP verification
samples were collected. Five (1.0%) samples were violative for a food safety defect. The five violative samples
are described in Table 6. In 4 out of the 5 instances, FDA responded to the violative finding by taking an
appropriate regulatory action (i.e., warning letter, injunction) or the product was voluntary recalled or destroyed
by the firm. For one of the samples no regulatory action was taken, but the District has since been advised of the
situation for future follow up.
TABLE 6
Verification Samples
Product Analyses Classification Regulatory Action
Vacuum packaged hot smoked
Low water phase salt VAI No
fish
Paddlefish Roe Listeria monocytogenes OAI Warning Letter
Tuna Loins Elevated histamine level VAI Recalled product
Vacuum packaged hot smoke fish Low water phase salt OAI Injunction
Vacuum packaged cold smoked
Listeria monocytogenes OAI Voluntary product destruction
fish
In order to determine if there were circumstances observed during the associated inspection that could account
for the food safety defect in the sample FDA looked at the inspection history of the firms. The firms from which
the violative Listeria monocytogenes samples were collected and the firm from which the elevated histamine
sample was collected had histories of sanitation and HACCP issues that could have resulted in the violative
samples. The two firms from which the samples with low water phase salt were collected had a history of
HACCP deviations that could account for the violative finding.
RECOMMENDATIONS
This is the third biennial evaluation of the Seafood HACCP Program. In each of the six years of the industry
performance has improved. FDA has used the previous evaluations to make changes to the compliance
programs to focus inspection and training efforts on certain industry segments or specific food safety hazards.
These efforts have paid off as evidenced by the steady improvements over the years. However, despite increased
Agency efforts, certain industry segments continue to lag behind.
FDA recommends:
1. Continue to prioritize all manufacturers of high risk fishery products, particularly processors of

scombroid species and cooked ready-to-eat products, for annual inspection.

2. Prioritize processors and importers of aquaculture products increased inspection and training.
3. Issue the fourth edition of the Fish & Fisheries Products Hazards and Control Guidance to facilitate
compliance by processors of scombroid products.
4. Complete an evaluation of firms that need a HACCP plan but still do not have one and determine what
follow up action is needed to ensure compliance on this issue.
HACCP | Seafood
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Hypertext updated by jbh/cjm October 11, 2005

US FDA - CFSAN FDA's Evaluation of The Seafood HACCP Program For 2002 - 2003

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US FDA - CFSAN FDA's Evaluation of The Seafood HACCP Program For 2002 - 2003

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US FDA/CFSAN FDA's Evaluation of the Seafood HACCP Program for 2002/2003

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FDA's Evaluation of the

Compliance Programs Objective

Domestic Seafood Products Compliance Program Background

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Imported Seafood Products Compliance Program Background

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Domestic Industry Progress

(a) "Compliance Rate"

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(b) Success on Individual Elements: Domestic Industry Overall

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(c) Success on Individual Elements: Specific Domestic Industry Sectors

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HACCP plan present when needed or HACCP plan not

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Domestic Molluscan Shellfish

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Foreign Industry Progress

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Adequate identification of Critical Limits (all relevant hazards) in

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*ID = Insufficient Data

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scombroid species and cooked ready-to-eat products, for annual inspection.

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