May 13, 2005
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.
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 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.
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.
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.
Seafood HACCP Compliance as a Factor of NAI, VAI, AND OAI Inspection Classification Rates 1998 - 2003
(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.
|Mandatory HACCP/Sanitation Provision||1998
|1||HACCP plan present when needed or HACCP plan not needed - all firms inspected||79||84||88||88||90||91|
|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|
|4||Adequate identification of hazards in plan - all firms with plan||66||83||86||86||89||87|
|5||Adequate identification of Critical Control Points in plan - all firms with plan||ND||86||81||84||85||86|
|6||Adequate identification of Critical Limits in plan - all firms with plan||67||66||75||77||80||82|
|7||Adequate identification of monitoring procedures in plan - all firms with plan||67||76||78||79||77||79|
|8||Adequate identification of corrective actions in plan - all firms with plan||76||83||86||87||91||89|
|9||Meet training requirement - all firms inspected||84||85||86||85||86||89|
|10||Adequate implementation of HACCP monitoring procedures - all firms with a plan||72||78||77||77||77||76|
|11||Adequate HACCP monitoring records - all firms with a plan||71||69||68||70||71||73|
|12||Adequate corrective actions taken after critical limit deviations or no corrective actions needed - all firms with a plan||81||86||92||91||93||92|
|13||Adequate corrective action records when corrective actions taken or no corrective actions needed - all firms with a plan||72||88||95||95||95||94|
|14||Overall average of items 4-8, and 10-13, covering success with 9 individual plan and implementation elements-- all firms with a plan||64||79||82||83||84||84|
|15||Adequate sanitation controls (All GMPs and all sanitation monitoring & record keeping) - all firms inspected||21||34||47||50||51||54|
|16||No significant GMP violations - all firms inspected||48||56||65||67||66||67|
|17||Adequate HACCP-type sanitation monitoring - all firms inspected||44||77||76||77||77||78|
|18||Adequate sanitation monitoring records - all firms inspected||43||58||69||74||71||79|
|19||Adequate sanitation corrections taken when sanitation deficiencies noted or no sanitation corrections needed - all firms inspected||ND||94||91||92||91||92|
|20||Adequate sanitation correction records when sanitation corrections taken or no sanitation corrections needed - all firms inspected||72||89||87||92||91||92|
|Pathogens||All firms with a plan||70||71|
|Cooked ready-to-eat firms||87||90||85||86||80||81||75||79||91||91||79||75||70||71||91||91||94||94|
|Smoked seafood firms||81||91||85||92||72||77||71||74||91||92||72||76||61||69||90||91||94||94|
|Cured seafood firms||87||82||72||88||72||79||66||79||94||88||78||82||69||70||94||100||97||100|
|Dried seafood firms||83||100||83||91||74||91||78||86||91||100||78||91||65||95||91||100||100||95|
|Breaded/Stuffed seafood firms||86||95||89||92||87||86||85||90||92||94||87||86||84||87||97||97||99||98|
|Parasites||All firms with a plan||98||98|
|Cured seafood firms||94||94||97||94||97||91||97||100||97||97||97||94||100||100||100||100||100||100|
|Nonscombroid finfish species firms||98||98||98||97||98||99||98||98||100||99||98||99||98||97||99||99||99||99|
|Ciguatera||All firms with a plan||100||100|
|Nonscombroid finfish species firms||99||99||99||98||98||98||98||98||99||98||98||100||98||100||99||100||99||100|
|Histamine||All firms with a plan||86||84|
|Scombroid species firms||96||95||90||91||83||85||81||80||92||89||75||75||70||73||95||93||96||96|
|All firms with a plan||97||96|
|Aquacultured fish firms||95||91||98||96||98||93||91||98||98||93||95||91||98||91||100||96||100||98|
|Nonscromboid finfish firms||98||96||96||96||96||96||94||96||98||97||94||97||93||95||98||98||98||98|
|Aqua-cultured drugs||All firms with a plan||99||98|
|Acquatulured fish firms||95||83||98||91||98||85||95||85||95||89||91||87||93||87||100||93||100||94|
|Food additives||All firms with a plan||95||98|
|Physical hazards||All firms with a plan||97||98|
|Mixed fishery products firms||93||97||94||98||97||99||96||99||99||99||99||99||100||99||99||99||99||99|
|Breaded/Stuffed seafood firms||95||100||98||100||97||99||97||99||96||100||98||100||98||98||100||100||100||99|
Domestic Molluscan Shellfish
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.
|Mandatory HACCP/Sanitation Provision||Molluscan Shellfish 2001||Molluscan Shellfish 2003||Cooked, Ready-to-Eat 2003||Scombroid Species 2003|
|Adequate identification of all relevant hazards in plan - all firms with a plan||96||97||90||95|
|Adequate identification of Critical Control Points (all relevant hazards) in plan - all firms with a plan||96||96||86||91|
|Adequate identification of Critical Limits (all relevant hazards) in plan - all firms with a plan||82||78||81||85|
|Adequate identification of monitoring procedures (all relevant hazards) in plan - all firms with a plan||81||93||79||80|
|Adequate implementation of HACCP monitoring procedures (all relevant hazards) - all firms with a plan||90||93||75||75|
|Adequate HACCP monit91oring records (all relevant hazards) - all firms with a plan||90||95||71||73|
|Adequate corrective actions taken after critical limit deviations or no corrective actions needed (all relevant hazards) - all firms with a plan||93||84||89||93|
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.
|Mandatory HACCP Provision
* 2002-Insufficient Data
|HACCP plan present when needed or no HACCP plan needed - all firms inspected||100||87||86||82|
|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 with a plan||50||61||55||73|
|Adequate identification of Critical Control Points (all relevant hazards) in plan - all firms with a plan||50||70||80||73|
|Adequate identification of Critical Limits (all relevant hazards) in plan - all firms with a plan||53||66||61||60|
|Adequate identification of monitoring procedures (all relevant hazards) in plan - all firms with a plan||36||68||65||64|
|Adequate identification of corrective actions (all relevant hazards) in plan - all firms with a plan||47||96||94||82|
|Meet training requirement - all firms inspected||100||100||95||93|
|Adequate implementation of monitoring procedures (all relevant hazards) - all firms with a plan||39||79||72||71|
|Adequate HACCP monitoring records (all relevant hazards) - all firms with a plan||ND||90||91||56|
|Adequate corrective actions taken after critical limit deviations or no corrective actions needed (all relevant hazards) - all firms with a plan||ND||82||94||87|
|Adequate corrective action records when corrective actions taken or no corrective actions needed (all relevant hazards) - all firms with a plan||ND||92||97||89|
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.
|Special Requirements for Imported Products||1998
|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|
|3||Adequate affirmative steps accomplished in practice and documented||50||48||55||58||52||48|
|4||Affirmative steps accomplished in practice and documented by product category|
|Cooked Ready to eat||57||50||40||55||67||62|
*ID = Insufficient Data
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.
|Vacuum packaged hot smoked fish||Low water phase salt||VAI||No|
|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 fish||Listeria monocytogenes||OAI||Voluntary product destruction|
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.
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.
- Continue to prioritize all manufacturers of high risk fishery products, particularly processors of scombroid species and cooked ready-to-eat products, for annual inspection.
- Prioritize processors and importers of aquaculture products increased inspection and training.
- Issue the fourth edition of the Fish & Fisheries Products Hazards and Control Guidance to facilitate compliance by processors of scombroid products.
- 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.