FDA's Evaluation of the
Seafood HACCP Program for
Fiscal Years 2004/2005

Summary

This evaluation covers the status of domestic seafood processors and importers and international seafood processors in Fiscal Years 2004 and 2005 in operating preventive controls under FDA's Hazard Analysis Critical Control Point (HACCP) Program. These Fiscal Years represent the seventh and eighth years of the seafood HACCP program.

This is the fourth such evaluation. The previous evaluations, beginning with the first issue in December 2000, included all the data collected since 1998, the first year of mandatory Seafood HACCP controls. Starting with this fourth evaluation, FDA will only report data collected since the previous evaluation. Interested parties can view the previous evaluations for data prior to the last two years. All four evaluations are available at Seafood HACCP.

Program Objective

HACCP is a science-based system of preventive controls for food safety that commercial seafood processors develop to identify potential food safety hazards and implement to keep them from occurring. The FDA Seafood 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 safe and wholesome fish and fishery products in the U.S. This is done by determining 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 procedural guidance to the field for ensuring compliance by domestic and foreign processors that distribute fish and fishery products in interstate commerce or export product to the United States (U.S.). Following the promulgation of 21 CFR 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 these processors implement a system of preventive controls, in addition to ensuring compliance with more traditional regulatory requirements, such as the Current Good Manufacturing Practice Regulation.

CP7303.842 provides supplemental coverage for products also 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. Historically, FDA has controlled imports by reviewing customs entries, conducting field exams, collecting samples for laboratory analysis, and placing products and processors with a history of problems on detention without physical examination. This surveillance program addresses the control of pathogens, filth, parasites, decomposition, aquaculture drugs, bio-toxins, and illegal food and color additives in imported fish and fishery products. These efforts continue under the present compliance 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 in the import control strategy. Under the HACCP system of controls, the importer and the foreign processor share the responsibility for seafood safety. Foreign processors that ship fish or fishery products to the U.S. must operate in conformance with the Seafood HACCP Regulation. In addition, importers are required to take steps to verify that their imported products are obtained from foreign processors that comply with the Seafood HACCP Regulation. This Compliance Program provides instructions for the inspection of importers to verify that the products they offer for entry are obtained from foreign processors that are in compliance with the requirements of the Seafood HACCP Regulation.

Discussion

On the domestic side, this evaluation reflects the implementation of seafood HACCP programs by processors. The data is based on observations by FDA and state inspectors, operating under contract or partnership agreements with FDA, during regulatory inspections. The data included in the tables in this report is based on actual inspections conducted during the fiscal year, not the total number of firms in the FDA inventory. Not all firms are inspected annually. The processors are prioritized for inspection based on a combination of the potential safety risks associated with the products and the compliance history of the processor. 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 153 processors in 20 countries that were visited by FDA investigators during FY 2004 and FY 2005. It also includes a summary of the implementation of seafood HACCP controls by U.S. importers.

Like the previous evaluations, this one lists the most significant elements of the program in tables and provides the percentage of processors that succeeded in accomplishing each of these elements in the last two years FY 2004 and 2005. The accompanying narrative addresses specific aspects of the data, 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 classified by FDA as NAI (signifying that no objectionable conditions were found during the inspection) and the number of firms classified as VAI (signifying that objectionable conditions were found but if corrected in a timely manner would not warrant regulatory or administrative action) were virtually equal in FY 2005 (See Figure 1). These figures have only changed slightly for the last three years.

The group of firms with an OAI classification (signifying that objectionable conditions were found that warrant regulatory or administrative action) has consistently been the smallest of the three percentages. Based on FDA's classification system, approximately 91% of firms were "in compliance" (NAI or VAI) in FY 2005. This percentage has not changed since FY 2003.

Overall, the domestic industry continues to make a slight improvement in their implementation of seafood HACCP systems, but the rate of progress has leveled off compared to the early years of the program. Of the eleven significant HACCP program elements, the implementation of six elements s improved during the FY 2004-2005 over the FY 2002-2003; the implementation of three of the key elements showed a slight decrease in compliance from one time period to the next; and the rate of compliance with the remaining two elements remained unchanged. The average increase in compliance was 2.3%; while for those elements that showed a decrease in compliance, the average drop was 1.3%. 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 85% (See Table 1).

Since the first evaluation, FDA has focused field resources and educational outreach at those industry segments that have lagged behind in implementation. In FY 2004 and 2005, FDA prioritized firms that process high risk products, which included scombrotoxin forming species, (i.e., those species of fish that can form scombrotoxin if time/temperature abused) and cooked ready-to-eat products or inspections and training because these segments of the industry lagged behind others in FY 2002 and 2003. The firms that process scombrotoxin forming fish species improving in their implementation in eight of the nine elements. However, cooked ready-to-eat seafood processors only showed progress in five of the nine elements. Despite these improvements, processors in these segments of the seafood industry continue to lag behind others in their implementation of seafood HACCP controls.

Processors of raw molluscan shellfish showed improvement in six of seven elements, based on available data for that commodity, between FY 2003 and 2005 (See Table 3). Raw molluscan shellfish processors out-performed processors of other high risk fishery products in only three of the seven elements.

Data on foreign processors that ship seafood to the United States is obtained during inspection of domestic importers and surveillance sampling activities. FDA has targeted processors of high risk products for facility inspections. The countries where these processors are located may or may not have requirements that are equivalent to FDA's, or provide sufficient oversight by local government agencies. In eight elements, foreign processor compliance percentages were higher in FY 2005 than in 2003. However, as stated in previous evaluations, comparisons from year between years are difficult because the data is compiled from inspections located in other countries and processors rather than return visits to the previously inspected processors.

Importers of fish and fishery products into the United States are required to take "affirmative steps" to determine that their foreign suppliers are operating in compliance with U.S. requirements. Seafood importers improved in two of three program elements that relate to them in FY 2003 through FY 2005. In fact, the most significant element, implementation and documentation of affirmative steps, improved by five percent during that time period. As with foreign processors, only a small percentage of the U.S. seafood importers are inspected each year, so comparison between years may not be appropriate. Nonetheless, as was the case in FY 2003, FY 2005 data shows that importers, as a whole, still have much progress left to make. Low rate of inspection is a likely contributing factor. FDA is in the process of taking steps to improve importer performance. These steps will be discussed in the recommendations section.

Results

Domestic Industry Progress

(a) "Compliance Rate"

The attached graph (Figure 1) shows the percent of inspections in FY 2004 and FY 2005 that were assigned to each of the three FDA inspectional classifications. These classifications are: "No Action Indicated" (NAI), "Voluntary Action Indicated" (VAI), and "Official Action Indicated" (OAI). 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 FY 2001, that distribution shifted to NAI; in FY 2002, the distribution shifted back to VAI as the largest classification group. Since FY 2003, NAI and VAI inspections have been leveling off to where they became equal percentages in FY 2005.

The OAI classification has consistently been the smallest category, but its size increased in each of the first four years as some firms failed the opportunity to make needed corrections. In the FY 2002-2003, the percentage of OAI firms dropped significantly from the percentages in the previous three years. This drop implies that some OAI firms have corrected their deficiencies either as a result of past regulatory action or because they otherwise recognized the need to do so. This decrease in numbers continued in FY 2004-2005. As Figure 1 indicates, the overall "compliance" rate (NAI plus VAI) for FY 2005 was about 91 percent.

Figure 1
Seafood HACCP Compliance as a Factor of NAI, VAI, and OAI Rates 2004-2005

(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 84% in FY 2003 to 85% in FY 2005 (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 85% in FY 2005.

Inspected firms that did not need a HACCP plan (because no food safety hazards were reasonably likely to occur) decreased from 31% of firms in FY 2001 to 26% in FY 2003 (line 2). This trend could be attributed to the fact that FDA ceased to inspect 100% of all the domestic seafood firms and was forced to concentrate its inspectional resources on the higher risk (i.e. typically more complex) and previously noncompliant firms first. This may have caused skewing of the data. Since FDA could only inspect processors of low risk products (that are more likely not to require a plan) as their remaining resources permitted, the percentage of firms that did not need a plan for the products inspected remained at 26% in FY 2005.

In FY 2003, the percentage of inspected firms that failed to have a HACCP plan when one was needed (line 3) was quite high, 18%. Firms without required HACCP plans were prioritized for follow-up inspections in FY 2004. These prioritized efforts resulted in the percentage decreasing significantly from 18% in FY 2003 to 14% in FY 2005.

Steady progress has been made in industry's adoption of adequate sanitation controls and HACCP-based sanitation monitoring and record keeping (line15). Although the 52% success rate has decreased 2% in FY 2005 from FY 2003, this item represents an extremely strict standard. Any sanitation infraction or sanitation monitoring deficiency causes a firm to be marked deficient for this item.

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

Table 2 presents the seafood HACCP inspection data sorted by an industry category and the food safety hazard. Table 2 differs from those in Table 1 in that Table 2 shows success in controlling the single hazard identified. Table 2 lists the overall industry success in controlling a single food hazard, which is followed by a breakdown of the individual successes of each industry category where that hazard is likely to occur. By contrast, Table 1 shows the success of inspected processors in controlling all hazards that might be relevant to their operations. These differences make it difficult to compare an industry sector's performance in Table 2 to the industry as a whole in Table 1. A more meaningful comparison is to compare a sector's performance in Table 2 against the performance of the other sectors in Table 2.

When the data is viewed by industry category and food safety hazard, the improvements in compliance shown by FY 2005 reflect the adjustment in inspectional priorities in FY 2003 to correct lagging implementation. As an apparent consequence, improvement occurred from FY 2003 to 2005 for the control of histamine by processors of scombrotoxin forming species. Success by processors of scombrotoxin forming species increased in 8 of 9 elements. However, cooked ready-to-eat was not as successful and increased in only 5 of 9 elements between FY 2004-2005.

Notwithstanding, the recent progress by the scombrotoxin forming species processing industry, FDA continues to engage in significant activity to encourage further improvements by that sector. FDA is currently exploring the possibility of a "Histamine Outreach Project" that may involve other government agencies, academia, and the private sector to provide education in the importance of histamine controls (adequate cooling) from harvest on. Several approaches are under consideration including video and print information and training sessions directed at processors, importers, and fishermen.

One segment of industry which has lagged behind is the primary processors of aquacultured seafood with respect to the control of aquaculture drugs. In fact, success rates are decreasing for control of this hazard. However, as reported in previous evaluations, because of the small number of aquaculture processors inspections (78 inspected in FY 2003, and 79 in FY 2005), the data is subject to greater variability and uncertainty than data for other segments. In FY 2001, FDA first reported this trend, but could not identify the cause. This trend has reversed itself in FY 2004-2005, with an improvement in 7 of 8 elements. However, FDA will continue to analyze the data for explanations in the trend.

Success rates also remained relatively low for the control of pathogens by processors of cured and dried fishery products. The adequacy of controls by processors of cured fishery products increased from FY 2003 to 2005 by an average of 5%, which is the opposite of FY 2001-2003. Adequacy of controls implemented by processors of dried fishery products worsened by an average of 6%. As with primary processors of aquacultured seafood, the numbers of inspected firms in these categories have been small (64 and 33, respectively, in FY 2003, 64 and 31, respectively, in FY 2005). Therefore, the percentages are quite volatile and may be misleading.

In FY 2002 and 2003, problems were mostly related to the implementation of HACCP plans, rather than to the adequacy of the plans themselves. This trend continued in FY 2004 and 2005. In particular, the implementation of monitoring procedures and the maintenance of monitoring records appeared the most problematic. FDA has discussed in previous evaluations 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 as the program progressed. The data continues to suggest that this shift has occurred.

Domestic Molluscan Shellfish Industry Progress

Tables 1 and 2 do not contain data for processors of raw molluscan shellfish (i.e., oysters, clams, mussels). State shellfish control authorities inspect processors in participating states under the National Shellfish Sanitation Program (NSSP) the results are not entered into FDA's National Seafood HACCP Inspection Database. The NSSP is a Federal/State cooperative program for the regulation of the raw molluscan shellfish industry. State regulatory authorities inspect these processors and FDA audits each participating State's regulatory program. As part of this audit, FDA shellfish specialists accompany State inspectors each year on a number of their inspections. A total of 107 accompanied inspections were performed in FY 2005. 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 by NSSP in FY 2003 and 2005, and also compares the FY 2005 data against two other segments of the seafood industry with similar elevated food safety risks, the cooked ready-to-eat segment and the scombrotoxin forming seafood segment for that same year. Like the data in Table 1, the data in Table 3 is organized in a way that helps FDA identify program elements that could be the source of performance problems so that regulatory priorities can be adjusted.

On average, molluscan shellfish processors performed better in the development and implementation of HACCP plans than the other high risk processors they were compared to. Additionally, improvement in compliance was seen between FY 2003 and 2005 in 4 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 requirements provide 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, one average, processors of molluscan shellfish performed slightly worse in identification of critical limits and taking appropriate corrective action, than the other seafood processors to which they were compared. It is worth noting that the shellfish processors covered under the FDA "accompanied" inspections are only a representative sample of the entire industry and may vary from year to year. Consequently, comparisons from year to year carry some inherent uncertainty.

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 approximately 159 countries. A number of these countries have advanced mandatory regulatory systems for seafood, while others do not. FDA's traditional strategy is to review entries of products being offered for importation into the U.S., and select products for examination at ports-of-entry. The examination is primarily directed toward determining whether the product is misbranded, decomposed, or contains substances that would cause it to be adulterated under U.S. law. This examination cannot reliably reveal if the foreign processors have adequate Seafood HACCP programs in place. And, while it could be inferred that some adulterated products were not processed under fully functioning HACCP systems, the specific HACCP deficiency cannot be identified without more information.

Consequently, FDA has implemented two additional strategies to augment port-of-entry examination. The first strategy is the requirement of the Seafood HACCP Regulation that U.S. importers take "affirmative steps" to help ensure that imported seafood products are safe and have been processed in accordance with U.S. Seafood HACCP requirements. Affirmative steps vary and FDA recognizes that importers may not have the technical expertise to evaluate a seafood processor's HACCP controls. Nonetheless, the "affirmative steps" requirement is a novel food safety control. FDA now inspects importers at their places of business to determine whether they are meeting their "affirmative steps" obligations. That topic is covered in the next section of this report.

The second strategy involves on-site Seafood HACCP inspections of foreign processors by FDA investigators. In FY 2004 and 2005, FDA sent inspection teams to ten countries each of those years. The trips had several objectives. FDA's primary mission was to evaluate the seafood HACCP programs of the selected processors. Additionally, FDA sought to develop contacts and relationships with the foreign competent authorities responsible for monitoring seafood processors and to provide training to both the competent authorities and industry, when requested. During the FY 2004 and 2005 visits, 81 and 72 seafood processors, respectively, were inspected for compliance with U.S. seafood HACCP requirements.

FDA's selection of countries and foreign processors for inspection is based on several factors. The agency considers emerging issues with regards to the seafood industry and/or to particular regions, the volume of products submitted for entry, the types of products exported to the U.S., and FDA surveillance sampling data. FDA normally selects countries that export significant volumes of products to the U.S., but also tries to include a limited number of countries that have not been previously visited by FDA in each year's trips if resources are available. Within the selected countries, processors that have submitted violative products have an increased priority for inspection followed by processors of high risk potential products that have not had products detained or refused by FDA. FDA may schedule include follow-up inspections of previously inspected foreign processors that have implemented modifications to their seafood HACCP programs at FDA's request.

Table 4 provides a summary of observations made during the foreign inspections in FY 2004 and 2005. In the FY 1998/1999 and FY 2000/2001 evaluation reports, FDA attempted to compare results of foreign inspections to those of domestic inspections. The agency discontinued that process in FY 2002/ 2003 and has not done a comparison for FY 2004/2005. 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 the implementation of the seafood HACCP regulation in other countries would lag somewhat behind that in the United States. There were three reasons for this expectation. First, processors in other countries may not be able to readily obtain the necessary information, with regards to FDA's requirements, which will help them understand the principles involved. Second, as previously stated, firms in some foreign countries may not be receiving regulatory feedback on HACCP principles from local regulatory authorities. Third, local safety recommendations may not be consistent with FDA's, and without knowledge of FDA's safety recommendations, a foreign processor may be unable to meet our expectations. FDA's strategy to help overcome these disadvantages is to continue its foreign inspection program and to continue working with local regulatory officials to improve their understanding of our requirements. Unfortunately, there is no equivalent substitute for FDA's domestic seafood processing surveillance program which provides regular, consistent feedback on the adequacy of HACCP systems.

In FY 2005, the percentage of success for five program elements lagged significantly behind those of domestic processors. The identification of significant Hazards, Critical Control Points, Critical Limits, Monitoring Procedures, and Corrective Actions averaged fifteen percentage points lower for foreign processors from those of domestic processors. This may be attributed to some foreign processors and local competent authorities failing to understand or be aware of FDA's safety recommendations. It may also be in response to FDA's targeting of suspected non-compliant foreign processors for inspection. It is not possible to specifically identify the cause of the disparity. FDA plans to continue to target countries and processors with identified problems on future inspection trips.

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 which describe how they will ensure that the seafood products they import are safe, develop written product specifications addressing product safety issues, and implement one or more "affirmative steps" as a method of to help ensuring that their foreign sources have implemented seafood HACCP controls. They must maintain these records and provide them to FDA during inspections or upon request.

Prior to the Seafood HACCP Regulation, 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 currently estimates that there are several thousand seafood importers operating in the United States. During FY 2004 and 2005, the agency inspected 558 and 422 of these businesses, respectively. The investigators complete a data form, similar to the ones used for seafood processors, to provide detailed information about the inspection to the National Seafood HACCP Database. The data from these inspections is displayed in Table 5. It is important to note that, because of the relatively small number of importers inspected as compared to the estimated total number of seafood importers, many of the importers inspected, even in 2005, were being inspected for the first time. This factor should be taken into account when making comparisons between years.

The above caveat notwithstanding, earlier evaluations suggested that importers generally improved between FY1998 and 2001 in their preparation of written product specifications and written "affirmative steps". Since then, importers have made little progress in actually implementing and documenting adequate affirmative steps. Importers of scombrotoxin forming species have had, and continue to have, a particularly low success rate. The lag in compliance for importers of scombrotoxin forming species mirrors the lag domestic processors of these products exhibit.

Recommendations

This is the fourth biennial evaluation of the Seafood HACCP Program. In each of the eight years of seafood HACCP industry performance has improved. FDA has used the previous evaluations to make changes to the compliance programs and 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 are slow to improve.

FDA recommends:

1. Continue to prioritize all processors of high risk potential fishery products, particularly processors of scombrotoxin forming species and cooked ready-to-eat products, for annual inspection.
2. Increase the inspectional priority of processors and importers of aquaculture products.
3. Issue the fourth edition of the Fish & Fisheries Products Hazards and Control Guidance to facilitate compliance by processors of scombrotoxin forming species.
4. Work on developing strategic, measurable goals for industry segments that have traditionally lagged behind.
5. Increase the number of importer inspections to reflect a more accurate representation of the size of the industry.
6. Implement outreach programs to educate importers with regards to their responsibilities and the options available to them.
7. Develop a system that creates a follow-up mechanism for foreign inspections based on domestic importer inspectional findings.
8. Continue foreign inspections targeting processors of high risk products. Implement outreach programs for foreign competent authorities and industry groups to provide guidance in FDA's safety recommendations.
9. Continue to plan and implement the "Histamine (Scombrotoxin Forming) Outreach Project".