New standards promulgated by the Food Safety and Inspection Service pose new challenges to the poultry industry.

On February 4, the US Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) released an advance copy of new performance standards intended to help reduce Salmonella and Campylobacter in raw chicken parts and not-ready-to-eat (NRTE) comminuted (ground) chicken and turkey products.[1] In the document, FSIS recognizes that the presence of Salmonella and Campylobacter in raw poultry cannot be eliminated through the commercial production and slaughter practices currently employed in US industry. Rather, the performance standards are designed to minimize their incidence.

Specifically, the new Salmonella standards will require contamination rates of no more than 25% in comminuted chicken, 13.5% in comminuted turkey, and 15.4% in chicken parts. The Campylobacter standards will require contamination rates of no more than 1.9% for comminuted chicken and turkey, and 7.7% for chicken parts.

The frequency of sampling will be determined on the basis of production volume and history of sampling results. FSIS will sample product from the largest volume establishments once per week and will decrease incrementally the number of samples it collects from establishments producing less volume of product. FSIS may sample a small number of establishments up to six times per month.

Based on results of the sampling, FSIS will categorize establishments according to the criteria below and post on its website the category of all eligible establishments:

  1. Category 1. Consistent Process Control:

Establishments that have achieved 50% or less of the Salmonella or Campylobacter maximum allowable percent positive during all completed 52-week moving windows over the last three months.

  1. Category 2. Variable Process Control:

Establishments that meet the Salmonella or Campylobacter maximum allowable percent positive for all completed 52-week moving windows but have greater than 50% of the maximum allowable percent positive during any completed 52-weeks moving window over the last three months.

  1. Category 3. Highly Variable Process Control:

Establishments that have exceeded the Salmonella or Campylobacter maximum allowable percent positive during any completed 52-week moving window over the last three months.

  1. Passing. Establishments that meet the Campylobacter maximum allowable percent positive for NRTE comminuted chicken or turkey during all completed 52-week moving windows over the last three months.
  2. Failing. Establishments that have exceeded the Campylobacter maximum allowable percent positive for NRTE comminuted chicken or turkey during any completed 52-week moving window over the last three months.

While such publication activity could be considered an enforcement tool in its own right, the document also specifies that FSIS will schedule a Public Health Risk Evaluation (PHRE) or Food Safety Assessment (FSA) for establishments that

  • do not meet the pathogen reduction performance standards;
  • have produced products with repetitive Salmonella or Campylobacter serotypes of public health concern, or repetitive antibiotic resistant Salmonella; and
  • have Salmonella or Campylobacter pulsed-field gel electrophoresis (PFGE) (or whole genome-sequencing, as it becomes available) patterns matching those found in recent outbreaks or epidemiologically linked to illnesses.

FSIS will also conduct an assessment of an establishment’s Hazard Analysis Critical Control Point (HACCP) plan and Sanitation Standard Operating Procedures, focusing on the establishment’s planned corrective actions. If after 90 days the establishment has not gained process control (as determined by FSIS’s follow-up sampling and the results of the PHRE or FSA) and the establishment has not taken corrective actions, FSIS will likely take enforcement actions, such as issuing a Notice of Intended Enforcement (NOIE) or suspending inspection. At the same time, FSIS has stated that it would not issue a NOIE or suspend inspection based solely on the fact that an establishment did not meet a performance standard.

The apparent contradiction posed by such language illustrates FSIS’s willingness to aggressively assert enforcement authority in this area. In theory, FSIS remains constrained by the holding of the Fifth Circuit in Supreme Beef v. USDA, 275 F.3d 432 (2001) that blocked its attempt to suspend operations at an establishment that had allegedly failed to meet a Salmonella performance standard. Under the new performance standards, FSIS appears to now assert that the undefined concept of “inadequate process control” is a valid legal basis for such action. But the discussion of the issue in the performance standards does little to indicate what—other than failure to meet the performance standard itself—would constitute such inadequate control, nor does it link that assertion to any particular grant of statutory authority.

FSIS will begin the new program 90 days after the upcoming publication of the performance standards in the Federal Register.