U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
September 30, 2002

FDA's Evaluation of the
Seafood HACCP Program
For Fiscal Years 2000/2001

Letter from Center Director
FDA's Evaluation of the Seafood HACCP Program For Fiscal Years 2000/2001

Dear Colleague:

Attached is an evaluation of FDA's Hazard Analysis Critical Control Point (HACCP) Program for seafood for fiscal years 2000 and 2001. This is the second such evaluation.

The report demonstrates steady progress by the seafood processing industry in implementing the full range of preventive controls that became mandatory in December 1997, as measured against the 1998/1999 evaluation. For each of the four years the trend has been for the number of firms with no significant HACCP violations to increase and for the number of firms with HACCP violations warranting correction to decrease. This means that many firms have been correcting their deficiencies voluntarily. Firms with no significant violations now constitute the largest inspectional classification. The group of firms with HACCP violations that warrant regulatory or administrative action, a third inspectional classification, has consistently been the smallest, and has increased each year as some firms have failed the opportunity to make needed corrections. Based on FDA's historical classifications, in FY2001 approximately 85% of firms could be considered to be "in compliance."

Targeted inspections and education efforts aimed at improving those industry segments that were lagging behind in 1998 and 1999, in terms of implementation, appear to have been effective for some industry segments, but only partially effective for others.

HACCP is a science-based system of preventive controls for food safety that commercial food processors develop and operate to identify potential problems and keep them from occurring. The evaluation covers implementation of the HACCP program by about 4100 U.S. seafood processors, most of which are small businesses, and which process over 350 species of fish. It also covers implementation by U.S. molluscan shellfish processors, foreign seafood processors, and U.S. seafood importers.

In conclusion, this report shows that the seafood HACCP program has increased the margin of safety for American consumers. This state-of-the-art program is increasingly being adopted and properly implemented by a broad and diverse array of seafood processors. But this report also identifies segments of the industry that need continued focus and government oversight. FDA will continue its efforts in this regard in fiscal year 2003.

Sincerely yours,   Joseph A. Levitt Director, Center for Food Safety and Applied Nutrition

FDA's Evaluation of the
Seafood HACCP Program
For Fiscal Years 2000/2001

SUMMARY

This evaluation covers progress made in Fiscal Years 2000 and 2001 by domestic and international seafood processors and by importers in adopting preventive controls under FDA's Hazard Analysis Critical Control Point (HACCP) Program.  These Fiscal Years essentially represent the third and fourth years of the HACCP program. 

This is the second such evaluation.  The first, issued on December 8, 2000, evaluated progress through the first two years of the program, 1998 and 1999. 

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. 

On the domestic side, this evaluation covers implementation of the program by approximately 4100 U.S. seafood processors, as observed during regulatory inspections by FDA and some states operating under contract or partnership agreements with FDA.  It also includes information about 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, it reviews the status of HACCP implementation by 174 processors in 19 countries that were visited by FDA inspectors during 2000 and 2001.  It also covers progress by importers of foreign seafood products in ensuring that their foreign suppliers are complying with U.S. HACCP requirements.

Like the previous evaluation, 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.  Accompanying narrative addresses specific aspects of the data in the tables.  The previous evaluation included a full explanation of HACCP and the specific elements of the program as well as a relatively lengthy discussion on the significance and meaning of most of the percentages in the tables.   This evaluation builds on the previous one but does not repeat the explanation of HACCP or the meaning of each percentage. Rather, it discusses noteworthy trends and similar matters that are emerging, continuing, or reversing since the previous evaluation.

The seafood HACCP program raised the standard for compliance much higher than it had previously been for that industry. It is no longer sufficient that a particular lot of a processor's products be free of contaminants. Now, a seafood processor must have a system in place, consisting of several complex elements, that collectively makes it unlikely that contamination will occur in the future. 

In striving to meet this new standard, FDA expects steady industry improvement from year to year, and this is what occurred through the first years of the program.  For each of the years, the trend has been for the numbers of firms classified by FDA as NAI (i.e., "No Action Indicated," signifying that no objectionable conditions were found during the inspection) to increase and for the number of firms classified VAI (i.e., "Voluntary Action Indicated," signifying that objectionable conditions were found but were not sufficient to warrant regulatory or administrative action) to decrease.  This means that many VAI firms are correcting their deficiencies voluntarily. In the first three years of the program VAI constituted the largest inspectional classification. In 2001, that had shifted to NAI, an important shift.  The OAI classification (i.e., "Official Action Indicated," signifying that objectionable conditions were found that warrant regulatory or administrative action) has consistently been the smallest, and has increased each year as some firms have failed the opportunity to make needed corrections. Based on FDA's historical classifications, in FY 2001 approximately 85% of firms could be considered to be "in compliance."

Overall, the domestic industry continues to make steady progress in implementing HACCP systems, but the rate of progress is reduced from previous years. Of nine significant HACCP program elements, the percentage of processors that succeeded increased on seven of them between 1998 and 1999; it increased on six elements between 1999 and 2000; and it increased on five elements between 2000 and 2001. The percentage of the industry that succeeded on any given element increased on average by seven percent between 1998 and 1999; while it increased by three percent between 1999 and 2000, and by one percent between 2000 and 2001 (See Table 1).  Targeted inspections and education efforts aimed at improving those industry segments that were lagging behind in 1998 and 1999, in terms of implementation, appear to have been effective for firms that make cooked, ready-to-eat products and breaded/stuffed products, but have been only partially effective so far for firms that make smoked products and that process "scombroid species," i.e., those species of fish that form scombrotoxin if time/temperature abused (See Table 2).  FDA continues to prioritize these firms for regulatory inspections and training. Processors of raw molluscan shellfish showed good progress, based on 1999 and 2001 data (See Table 3).

Data on foreign processors that ship seafood to the United States are obtained during FDA inspection trips to foreign countries.  So far, 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.  While the success rate per element for these processors is, overall, below the U.S. average, a number of elements show dramatic improvement from the first foreign inspections in 1999, and the overall trend is favorable. However, the foreign data involves visits to different countries and different processors from year to year, rather than return visits to the same U.S. processors. This makes comparison from year to year difficult.

Importers of foreign seafood products into the United States made progress on every element between 2000 and 2001 and show substantial progress since 1998.  On the other hand, most percentages for 2001 show that importers as a whole still have much progress left to make before their performance can be regarded as mature under this program.

DOMESTIC INDUSTRY PROGRESS

(a)  "Compliance Rate"

The attached graph (Figure 1) shows the trends in the percent of inspections conducted each year from 1998 through 2001 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 regulations, and that has failed to take appropriate "voluntary" action. Historically, firms classified NAI and VAI have been considered "in compliance."

For each of the four years, the trend has been for the number of NAI firms to increase and for the number of VAI firms to decrease. This means 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 2001, that shifted to NAI, an important shift. The OAI classification has consistently been the smallest, and has increased each year as some firms have failed the opportunity to make needed correction. As Figure 1 indicates, the overall "compliance" rate (NAI plus VAI) for 2001 was about 85 percent.

FIGURE 1
Seafood HACCP Compliance as a Factor of
 NAI, VAI, AND OAI Inspection Classification Rates

(b)  Success on Individual Elements:  Domestic Industry Overall

As shown by the data in Table 1, a significant majority of processors continue to do well on most of the individual elements of the program. The percentage of firms that had a HACCP plan when one was needed or did not need a plan (because no hazards were reasonably likely to occur) increased from the 1999 level of 84% to 88% in 2000, but then remained constant in 2001 (line 14).  For those firms that had a plan, the overall average rate of success in implementing individual HACCP program elements increased from 79% in 1999 to 82% in 2000 and then improved slightly for 2001, at 83%. In other words, for any of nine program elements, the average likelihood that a processor fully succeeded in implementing it was 83% in 2001.

Dramatic progress in program elements was not evident in 2001, when the data is viewed industry wide. Instead, increases of 1 to 3% were the norm.  Four years into the HACCP program, it may be that processors that are most willing and able to achieve compliance have done so, thus accounting for an apparent slowing in the rate of progress from year to year. The previously described increase in the OAI rate seems to confirm that regulatory action may be necessary to correct much of the remaining noncompliance.

While the overall trend is still toward improvement, it is worth noting that this trend is not seen on all elements.  For example, line 3 indicates that no progress was made in 2001 in reducing the number of firms that needed a HACCP plan but did not have one. This is despite the fact that this program element was prioritized for FDA field regulatory follow-up.  The causes of this trend have not as yet been identified. These firms will be prioritized for follow-up inspections in 2003.  

(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 processors in controlling the single hazard identified in any particular line item in the table. By contrast, Table 1 shows the success of 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, significant improvements can be seen in 2000 and 2001 in those segments of the industry to which educational and inspectional activities were refocused in 2000 to correct lagging implementation that was noted in 1998 and 1999. FDA initiated actions in 2000 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 seafood and smoked seafood, and control of scombrotoxin by processors of scombroid species. Those actions included various industry education initiatives and a focusing of regulatory inspections toward the problem areas.  As an apparent consequence, improvement occurred, for example, in HACCP plans for the control of pathogens by processors of cooked, ready to eat seafood and smoked seafood, and for the control of histamine by processors of scombroid species.

This progress notwithstanding, performance of the scombroid species processing sector remains among the lowest in the seafood industry when compared against other sectors in Table 2. This appears to be in large part due to a delay by the industry in either adopting appropriate harvest vessel controls to prevent histamine formation before the fish reach the first processor, or in engaging in histamine testing (as an alternative to harvest vessel controls).  An increase in the frequency of reported problems between 1999 and 2000 in one aspect of the HACCP plan, identification of critical control points, appears after further analysis to mostly be the result of problems with secondary processors, including many repackers and warehouses. It is likely that at least some of these repackers and warehouses were visited for the first time during 2000, as the emphasis had previously been on manufacturers.

The Agency continues to engage in significant regulatory action and educational programs directed toward all scombroid species processors to encourage improvement. Additionally, because of concerns by the industry that FDA's recommended critical limits cannot be met for large tunas, or long line caught tunas, FDA is conducting research in this area. The goal is to provide recommendations that are as practical as possible, while still being sufficiently protective of the public health.

Performance by the smoked fish processing sector also remains among the lowest in the seafood industry. This is likely because control of the Clostridium botulinum hazard is still one of most complex and controversial controls in the seafood HACCP program. In fact, one of the elements of the HACCP plan, identification of proper corrective action, showed a decline in performance from 2000 to 2001.  This industry segment saw the heaviest concentration of regulatory action, including injunction, in 2001 and 2002. Recent educational efforts have also addressed this industry segment.

One industry segment that had been performing quite well, the aquacultered fish sector (with respect to the control of aquaculture drugs) experienced an increase in reported problems generally, but especially in those program elements related to the development of proper HACCP plans. The cause of that trend is not known. However, because of the relatively small number of aquaculture processors (89 inspected in 2001), the data are subject to greater variability and uncertainty than data for other segments. The Agency will closely monitor the data for 2002 and determine at that time whether special corrective measures are warranted.

Despite the general improvement in the HACCP plans themselves, increases in reported problems were noted in 2000 and 2001 in a couple of elements relating to the implementation of HACCP plans. For example, reported problems increased significantly for implementation of monitoring procedures and/or maintenance of monitoring records for pathogen control by processors of smoked seafood and for aquaculture drug control by processors of aquaculture seafood.  This phenomenon may be explained by a shift in emphasis by investigators from a review of HACCP plans to an evaluation of the implementation of the plan, as firms have made progress in plan development. As such, the trends likely do not represent a worsening of conditions, but rather increased scrutiny. In addition, as mentioned above, the data on aquaculture processors is subject to significant variability and uncertainty.

One industry segment not given special emphasis as a result of the 1998/1999 evaluation report, breaded and stuffed seafood, experienced increased problems in 2000. In particular, problems were noted in the identification of critical control points and monitoring procedures in HACCP plans. An increase in inspection emphasis in 2001 may have helped these two elements to rebound, with increases in that year of 7% and 9%, respectively.

DOMESTIC MOLLUSCAN SHELLFISH INDUSTRY PROGRESS

Tables 1 and 2 do not contain data from 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, under which 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 255 accompanied inspections were performed in 2001.  This number represents more than 10% of the total number of these kinds of processors nationwide. 

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 1999 and 2001, and also compares the data for the molluscan shellfish industry in 2001 against two other industry segments with similarly elevated food safety risks, the cooked ready-to-eat segment and the smoked 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 generally 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, significant improvement was seen between 1999 and 2001 in five of the seven programs elements examined. The superior performance of molluscan shellfish processors in plan development can likely be accounted for 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 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 somewhat worse in taking appropriate corrective action than did the other processors to which they were compared. There was also a nine percent drop in the performance of the molluscan shellfish processing industry on this program element between 1999 and 2001. Although the causes of these trends have not as yet been identified, it is worth noting that the processors inspected under "accompanied" inspections as described above tend to differ from year to year. Consequently, the data do not generally reflect a worsening of performance by any specific processor from one year to the next.

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.  There are estimated to be about thirteen thousand foreign processors that export to the U.S. 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 regulations 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 2000 and 2001, FDA sent inspection teams to nine and ten countries respectively that are major exporters of seafood to the United States.  These numbers were significant increases from 1999, when four countries were visited. 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 2000 and 2001 visits, 85 and 89 seafood processors, respectively, were inspected for compliance with U.S. HACCP requirements.  Table 4 provides the results of these inspections from their first year in 1999 through 2001 and compares the 2000 and 2001 results against the results of domestic inspections for the same years.  There are several important distinctions between U.S. and foreign inspections performed by FDA that make comparisons between years and between domestic and foreign firms difficult: 1) foreign inspections are performed with different firms and in different countries from year to year, while domestic inspections are performed with essentially the same firms; 2) foreign inspections cover products with an elevated food safety risk, while domestic inspections cover products across the risk spectrum; and 3) foreign inspections are announced months in advance, whereas domestic inspections are unannounced. 

Although foreign seafood processors are subject to the same 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. On the positive side, foreign processors that ship to the United States from developing countries are clearly making an effort to learn the new requirements and comply with them.

As expected, in the aggregate, the foreign firms are behind their U.S. counterparts in most categories, although they did better in some.  In particular, performance was poorer by foreign processors in all areas of HACCP plan development except the identification of appropriate corrective actions.  This trend is likely the result of a relative lack of opportunity for guidance, training, and regulatory feedback on HACCP issues in developing countries.  Performance was also poorer by the foreign firms on the implementation of monitoring procedures. However, the foreign firms performed substantially better than did the domestic firms on the maintenance of HACCP monitoring records.  However, this trend may result from the generally abbreviated nature of foreign inspections, providing less time to the investigator to scrutinize monitoring records.

Most foreign firms visited in 2000 and 2001 had received the required HACCP training and had at least attempted to draft written HACCP plans. In fact, the percentages for these program elements were higher for the foreign processors than for the domestic processors, likely because of the necessity to pre-announce the foreign inspections. Nonetheless, there was clearly an understanding by the foreign processors that a HACCP plan was required if there were food safety hazards that were reasonably likely to occur, and that HACCP training was also required.

Notwithstanding the difference in the countries visited from year to year, there was substantial improvement by foreign processors as a group in a majority of program elements from 1999 to 2000/2001. The differences between 2000 and 2001 likely reflect different firms in different countries from one year to the next, as described previously.

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 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 regulations, 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 2000 and 2001 the agency performed 396 and 570 inspections of these businesses, respectively. For each inspection, the FDA inspector completes a data form to provide detailed information about the inspection in 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. seafood importers, many of the importers being inspected even in 2001 are 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 1998 and 2001.  On the other hand, many continue to experience problems with all three major provisions of the importer requirements: preparation of written product specifications; taking affirmative steps; and keeping appropriate records.  However, the data also indicate that these importers were reasonably successful at developing written verification procedures and product specifications when they attempted to do so. The most important hurdle to overcome for performance in this regard appears to be in educating importers on their responsibilities and ensuring that they take these responsibilities seriously. To help accomplish this goal, in 2001 FDA and the National Fisheries Institute held joint importer HACCP workshops in four major ports of entry.  All the workshops were well attended.

Overall, performance by importers increased from year to year, despite the fact that many were being inspected for the first time each year. However, the trends for the importers of the three selected products with elevated food safety risk (i.e. scombroid species, smoked seafood, and cooked, ready-to-eat seafood) was more erratic, with some years showing increases, and others showing decreases. This phenomenon was likely due to the fact that many were first time inspections.