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CFSAN/Office of Scientific Analysis and Support
August 3, 2004
FDA is preparing to revisit regulations on current good manufacturing practices in order to determine appropriate revisions to ensure a safe and wholesome food supply. A review of past recalls provides valuable information for FDA in its consideration of GMP regulations. Information gathered from recalls describes physical, chemical, and microbiological hazards that may occur during the production of food and will be useful in determining universal preventive controls to prevent, reduce, control, or eliminate foodborne hazards.
A recall is a firm's removal or correction of a marketed product which FDA considers to be in violation of the laws it administers. The relative level of health hazard attributed to each recalled product by FDA is reflected in an assigned recall classification number (i.e., I, II, or III). A class I recall is defined as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II recalls involve situations in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Finally, Class III recalls entail situations in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. For each recall action, the Agency works with the recalling firm to develop a recall strategy and to monitor the recall process. Among other things, this strategy determines whether public warnings should be issued, the level in the distribution chain to which recalls are extended, and the extent to which checks are performed by the firm and/or FDA to ensure that consignees have received notification about the recall and have taken appropriate actions.
For every recall or recall action, the FDA maintains a record with information pertaining to each recalled product. Details captured in the recall record include the reason for the recall, the strategy employed by the manufacturer or distributor to remove the product from distribution, and the actions FDA took in processing the recall. Additionally, each recall record contains information pertaining to adverse events, if any, that were reported by consumers to either the firm or the FDA following consumption of the product. Data collected on food recalls can be used to identify common problems and trends occurring in the food industry, and can be used to inform the public and the food industry of frequently occurring hazards so that steps can be taken to prevent further occurrences.
For this study, we reviewed FDA recall records for recall actions that were classified I or II for fiscal years 1999 through 2003 to identify those recalls that took place because of a GMP-related problem. By GMP-related problem, we mean those types of problems that could have been prevented by GMP-type preventive measures. GMP-type preventive measures include, but are not limited to, proper equipment sanitation, adequate training of employees, review of product labels for accuracy and agreement with the product formulation, and adequate preventive maintenance of equipment. Class III recalls were excluded since these recalled products are not likely to have caused adverse health consequences. In addition, only recall actions involving food products were reviewed; cosmetic and other non-food related recalls were excluded from the study. Recall actions that occurred as a result of a labeling or packaging problem have also been included in this analysis since packaged food products are required to have a label.
Each record was reviewed to determine the following information: the product recalled; the general recall category (i.e. labeling, microbiological contamination, foreign object); number of adverse events, if any, reported by consumers who ate the product; the entity responsible for first detecting the problem with the product; the nature of the problem that led to the recall; the processor level problem; and the recall classification (I or II).
In addition to the summary of the recall information, a separate literature review was conducted to identify the most common food safety issues encountered at the processor level in the food manufacturing industry.1 The following list of processor level problems was identified and wherever possible used to identify the root cause of the recalls. The most commonly identified of these processor level problems is also shown in Figure 1 of the results section:
All recalls were evaluated by two scientists to determine if the root cause of the recall was GMP-related or not GMP-related. The recalls were carefully reviewed in order to extract the reason the product was recalled, including the specific processor level problems listed above. Information on whether the recall was a microbiological, allergen, color, sulfite, or other problem was also captured. In addition, a simple random sample of 25% of the reviewed recall actions was selected to be reviewed a second time by senior food scientists at FDA with experience in food processing in order to confirm that the information from the recall was captured correctly. The random sample was generated using Research Randomizer.2 Data were then entered into a database and analyzed using SAS software.3
We reviewed a total of 1307 food recall actions, of which 648 (50%) were Class I and 659 (50%) Class II. Of these recalls, we found that 1146 recalls (88%) occurred because of a GMP-related problem (including labeling problems). Of the GMP-related recalls (N=1146), bakery products and fishery/seafood products had the largest number of recalls between 1999 and 2003 (Table I).
| Industry | # of recall actions | Percent |
|---|---|---|
| Bakery products | 217 | 18.94% |
| Fishery/seafood products | 135 | 11.78% |
| Bean/vegetable products | 88 | 7.68% |
| Multiple food dinner products | 85 | 7.42% |
| Non-chocolate candy products | 75 | 6.54% |
| Fruit products | 66 | 5.76% |
| Ice cream products | 62 | 5.41% |
| Chocolate products | 50 | 4.36% |
| Snack food products | 48 | 4.19% |
| Beverage/beverage base products | 38 | 3.32% |
| Cheese products | 29 | 2.53% |
| All other products | 253 | 22.07% |
| Total | 1146 | 100% |
Thirty four percent (34%) of the recalls involved undeclared allergenic ingredients (such as peanut, tree nuts, egg, milk, soy, wheat, fish, or crustacea) and 28% of the recalled products contained an undeclared, uncertified, or unapproved color such as tartrazine or ponceau 4R. Recall actions were generally categorized as involving labeling problems (65%), microbiological contamination (17%), unapproved color additives (8%), poisonous substances (3%), and foreign objects (3%).
The majority of specific processor-level problems related to the root causes of recalls were due to incorrect packaging/labeling (Figure 1). Ineffective employee training and failure to follow established SOPs for processing also contributed to many recalls between 1999 and 2003. In 4% of the recalls, a specific processor level problem could not be determined from the record.
Figure 1: Recall actions by specific processor-level problems*
(N=1146)
* One or more processor level problems may be associated with each recall action
The recalls were also reviewed to determine the first entity to discover the problem with the recalled product. While 68% of the recalls were due to problems discovered by FDA, state and local agencies, or other officials (such as the Department of Defense and Canadian Food Inspection Agency), 18% were first discovered by consumers (reported as complaints or adverse events to FDA or firms), and only 14% by the manufacturing firms. There were 149 illnesses or injuries reported with these recalls. The reported injuries are most likely an under-representation of the true number of illnesses/injuries since outbreak related illnesses are not included and food related illnesses/injuries are not required to be reported to FDA.
Between 1999 and 2003, 88% of 1307 food related class I and class II recall actions most likely occurred due to a GMP-related problem. This report shows the segments of the food industry involved, the first entity to discover the problem with the recalled product, and the GMP-related problem that led to a recall. This information collected from recent recalls can provide useful direction in modernizing GMP regulations.
Public Meetings on Current Good Manufacturing Practice Regulations
