PURPOSE

MONITORING

The principal purpose of the Monitoring Plan of the 1998 FSIS National Residue Program (NRP) is to gather information on the occurrence of residue violations in passed carcasses from normal-appearing animals, and thereby serve as a transition to a HACCP-based residue program in 1999. In addition to using the information to develop its future public health programs, FSIS is also able to accomplish the following:

1. Providing Information to Industry and Consumers - The NRP enables FSIS to inform industry and consumers of residue problems and potential problems. Industry can use this information to reduce residue violations by improving their QA/QC and/or HACCP programs.
   
   
2. Identification and Follow-up of Violations - FDA and EPA set upper tolerances on allowed concentrations of residues of (respectively) drugs and pesticides in foods under the authority of the Federal Food, Drug, and Cosmetic Act. Any meat tissue containing drug or pesticide residues that are in excess of these tolerances, or else that have not been allowed for any use in that food animal, are considered to be in violation of the FFDCA. In cases where violative residues are detected in animals sold for human consumption, FSIS notifies the producer, and any parties involved in offering these animals for sale. These firms are subject to follow-up enforcement testing until compliance is demonstrated. If any product found to be violative has been held in retention at the abattoir by the USDA Inspector, it will be condemned. If product has already been distributed and an imminent hazard exists from the violation, the product may be recalled. In addition, Food and Drug Administration (FDA) and cooperating state agencies may make on-site visits to these firms. Typically, an educational visit by the state is the first step in attempting to correct a residue problem. If the problem is not corrected, subsequent visits, made by FDA, could result in enforcement action, including prosecution.
   
   
3. Deterrence - Publication of residue violation findings has a deterrent effect against continued violations within a given industry.

Special projects are designed to acquire information about the occurrence of specific residues in livestock and poultry, where lack of precise slaughter data makes it impossible to design a statistically based sampling plan for the animal population of concern. Thus, compound/slaughter class pairs that were initially slated for inclusion in the monitoring plan, but did not meet its statistical criteria, were instead investigated under the special projects category. Compounds for which no tolerance information is available were also included in this category.

COMPOUND SELECTION

MONITORING

This selection was made in two phases. The first phase consisted of selection of the compounds and compound classes of greatest public health and regulatory concern. Compounds and compound classes considered were: antibiotics, chlorinated hydrocarbons/organophosphates sulfonamides, arsenicals, halofuginone, carbadox, ivermectin, other avermectins, certain mycotoxins, phenylbutazone, veterinary tranquilizers, levamisole, beta agonists, florfenicol, tilmicosin, dexamethasone, neomycin, heavy metals, nitrosamines, and fluoroquinolones. Of these, the first seven (antibiotics, chlorinated hydrocarbons/organophosphates, sulfonamides, arsenicals, halofuginone, carbadox, and ivermectin) were selected for inclusion in this sampling program. Based on the consensus of the ad hoc committee levamisole, which had been sampled in previous years, was not included in the 1998 FSIS NRP. A brief justification for cycling out levamisole, as well as a discussion of the decision not to include mycotoxins, is provided in Section 2.

The second phase consisted of apportioning sampling for the selected compounds and compound classes among 27 defined slaughter classes (including eggs). This was accomplished using an ordinal decision matrix. For each compound or compound class, each slaughter class was scored under a range of categories that together indicated the overall public health and regulatory concern represented by that compound/slaughter class pair. These categories were: (1) contribution of the slaughter class to the domestic U.S. meat and poultry supply; (2) non-uniform consumption of the slaughter class; (3) international considerations; (4-6) historical data on residue occurrences; (7) regulatory intelligence information; (8) industry HACCP and QA/QC practices; and (9) compound toxicity. The magnitude of the scores obtainable in each category were weighted according to that category's importance. Each compound/slaughter class pair was scored in each category, using consistent standards. Totals for each compound/slaughter class pair were calculated and ranked. The ranked scores were used as a tool to select among four different sampling options: very high regulatory concern (480 analyses/year); high regulatory concern (300 analyses/year); moderate regulatory concern (230 samples/year); low regulatory concern (90 samples/year). Statistically, if the true violation rate is 1%, these sampling numbers yield probabilities of detecting a violation of 99%, 95%, 90%, and 60% (85% at a 2% violation rate), respectively. Sampling frequencies assigned to each compound/slaughter class pair are given in Section 7.

SPECIAL PROJECTS

No special projects were scheduled for 1998.