This case challenges the HAACP (Hazard Analysis and Critical Points) that was implemented by the Department of Agriculture (DOA) to replace the traditional visual inspection of meat in slaughter houses and meat processing plants. As the hazards from contaminated processed meat, especially ground meat, came to public attention in the 1980s, there was pressure on DOA to replace the visual inspection of meat with more efficient and effective bacterial testing for detecting contamination. At the same time, the U.S. was endorsing ISO international standards, which are based on process controls rather than just final product inspection. Consistent with this approach, DOA developed HAACP and promulgated administrative rules to require meat processors to comply with its provisions.
(Quoting from the case) . . . "the rule requires all meat and poultry processors to develop and implement a system of preventive controls to ensure the safety of their products. First, a meat processor must analyze its processing procedures and identify the critical points at which health hazards can be controlled. The plant must then (1) establish maximum and minimum limits for the temperature, humidity, pH, and chlorine levels of meat at those critical points; (2) monitor the levels of those measurements; and (3) take corrective action if their levels deviate from their limits."
"To evaluate the overall effectiveness of a meat processor's HAACP plan, the FSIS [Food Safety and Inspection Service] tests the level of Salmonella in a plant's finished product. If the level of Salmonella in a processor's product does not remain below a certain point--dubbed a "performance standard" by the FSIS--its HAACP plan is considered ineffective. In other words, the FSIS uses Salmonella as an "indicator organism" that measures a HAACP plan's effectiveness against not just Salmonella, but all pathogens. According to the FSIS, it chose Salmonella as its indicator organism because (1) it is the most common bacterial cause of food-borne illness; (2) FSIS baseline data showed that Salmonella colonizes in a variety of mammals and birds, and occurs at frequencies which permit changes to be detected and monitored; (3) current methodologies can recover Salmonella from a variety of meat and poultry products; and (4) intervention strategies aimed at reducing fecal contamination and other sources of Salmonella on raw product should be effective against other pathogens."
"The FSIS has established a three-step procedure to test whether a processor's HAACP plan is meeting the performance standards. First, the FSIS takes samples from a processor's finished product for 53 consecutive days. Id. If more than five of these 53 samples test positive for Salmonella, the plant is required to take immediate action to remedy its failure. The FSIS then conducts another round of tests. If more than five of the second set of samples test positive for Salmonella, the plant must this time reassess its HAACP plan and "take appropriate corrective action." A third round of tests is then administered. Failure of this third series of tests constitutes failure to maintain sanitary conditions and failure to maintain an adequate HAACP plan ... for that product, and will cause FSIS to suspend inspection services. Such suspension will remain in effect until the establishment submits to the FSIS Administrator or his/her designee satisfactory written assurances detailing the action taken to correct the HACCP system and, as appropriate, other measures taken by the establishment to reduce the prevalence of pathogens."
Plaintiff's meat processing facility failed some of the third series of tests, and, after negotiation and delays to allow compliance, DOA took steps to close the plant. Plaintiff then brought this proceeding to enjoin the enforcement of the HACCP rules as unauthorized by the enabling legislation and thus invalid. The court engaged in a Chevron analysis and first took a hard look at the enabling statutes, the Federal Meat Inspection Act ("FMIA"), 21 U.S.C. 601 et seq. The court found that the statute did allow DOA to use the Salmonella assay as an index for insanitary conditions, and that such insanitary conditions were a legitimate reason to close the plaintiff's meat processing facility. However, plaintiff further argued that its plant was not insanitary and that the contamination that was measured was due to the processing of contaminated carcasses. (Ironically, such contamination would not be detected through the traditional inspection process.) DOA conceded that it was possible for a meat plant to be perfectly sanitary and to fail HACCP because of prior contamination of the meat by earlier processing in other facilities. DOA argued, however, that it is plaintiff's duty to assure that the processed carcasses are not contaminated.
The court found that the statutory authority for HACCP was based on finding insanitary conditions at plaintiff's plant and there was no authority to use HACCP methodology to close plaintiff if the meat plant met the statutory standards for sanitation. At the court put it: "Chevron does not allow the USDA to deem a sanitary plant insanitary." Thus the court enjoined the closing of plaintiff's facility, finding that the plant was clean but the meat was contaminated, and that DOA was without authority to use HACCP to require plaintiff to assure the cleanliness of it the meat it processed. It is likely that this case will see further review by the courts as it seems to call the entire HACCP process into question. From a tort liability perspective, failing HACCP and the using the court to force the DOA to let you keep the plant open looks like a great way to trigger punitive damages if anyone is injured by contaminated beef - no jury is going to accept that a meat grinder has no responsibility to refuse known contaminated carcasses.
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