FSIS program results indicate processors need to clean up their act
By Bryan Salvage, Editor
In an effort to enhance enforcement of sanitation and other food safety requirements, FSIS' Review and Assessment program made unannounced visits to 1,014 meat and poultry plants from September 1993 through February 1995. More than half of the critical deficiencies (those that directly affected food products) and major deficiencies (those that had a high probability of affecting products) uncovered were in sanitation.
The results of this program were compiled last autumn in a published report entitled "Final Report of the 1,000 Plant Review." Here is part of the program's background and some of its findings:
-- Reviewers completed more than 34,500 observations of operations and reported 2,555 serious (critical and major) deficiencies. Sixty percent of all deficiencies were in sanitation
More than 90 percent of these sanitation deficiencies were found in less than half of the plants reviewed. Eighty-six percent were found in fewer than 40 percent of the plants.
More than one-third (38 percent) of the plants reviewed, however, had no sanitation deficiencies, and 76 percent had two or fewer sanitation deficiencies.
-- Accelerated Deficiency Notices (ADN) were issued to 129 plants citing serious control problems. FSIS inspection officials required immediate corrections for the serious deficiencies in these plants, and directed plants to develop and follow action plans to prevent deficiencies in the future
The Review and Assessment (R&A) team scheduled a follow-up review for all 129 plants that received an ADN on the initial review. At the time the data were analyzed for this report, 14 follow-up reviews had been scheduled but not completed.
For the remaining 115 plants, 91 follow-up reviews were completed. Seventeen plants had closed and seven had been referred to R&A's Internal Assessments Division for in-depth program assessments.
During the 91 follow-up reviews, nine plants were issued a second ADN and referred to the Internal Assessments Division. Fifty-eight of the other 82 plants were under Progressive Enforcement Action (PEA), either at the time of the follow-up review or at some point between the reviews.
Other plants closed temporarily, presumably to make some type of permanent change. The average time between reviews was 88 days, with a range of 29 to 158 days.
Field inspection managers also assessed the plants to determine whether PEA should be implemented or strengthened. Inspection Operations carries out the PEA program to adjust the type and intensity of inspection and other regulatory measures appropriate for plant non-compliance. FSIS has integrated R&A findings into the PEA decision process.
Further analysis indicates dramatic short-term decreases in sanitation problems in plants where the ADN/PEA enforcement tools have been applied.
"Results of the 1,000 Plant Review were issued by FSIS to develop proposed regulations that require plants to follow Standard Operating Procedures for sanitation," the executive summary of the "Final Report of the 1,000 Plant Review" project states. The project also contributed to the agency's decision to step up progressive enforcement actions and supported PEA measures in plants."
What went down?
During plant visits, reviewers documented critical and major deficiencies.
"This project was a major component of FSIS initiatives to enhance enforcement of sanitation and other food safety requirements by identifying plants with poor controls, and requiring plants to develop and follow corrective action plans," according to the program's executive summary. "Nearly two-thirds of the plants selected for review were recommended by FSIS managers because of compliance concerns; the balance was randomly selected."
Recommended plants (656) were identified as candidates for review by inspection supervisors, the director, R&A, or whistle-blower complaints; and as a result of products being implicated in possible violations of laws or regulations.
Control plants (358) were randomly selected from all plants not on the recommended list. These plants served as a control group for analysis purposes. Control plants were selected at a rate of about one control plant for every two recommended plants.
For the 1,000 plant review project, Program Review Division officers conducted in-depth reviews of each plant selected, categorizing and reporting review observations in terms of the 10 processes from the FSIS Inspection System Guide.
These plant reviews covered 185 inspection tasks within the 10 processes associated with high and medium risk to public health and food safety.
Review officers recorded only deficiencies that were directly affecting products (critical) or had a high probability of affecting products (major). All findings were discussed with local inspection officials and plant managers who were available at the time of the review.
The R&A program
The R&A program includes two divisions and six branches that provide independent monitoring of FSIS functions and industry compliance. The R&A program conducts several activities that complement each other to help measure program effectiveness and enhance enforcement. These activities include:
-- On-site plant reviews to monitor regulatory effectiveness and identify plants needing additional regulatory oversight
-- Operation of a complaint tracking system to identify plants for review and activities requiring broader assessment
-- Close liaison with external oversight offices (Office of Inspector General and General Accounting Office) to provide information for setting work priorities and allocating review and assessment resources. ? Program assessments and special reviews to supplement Inspector General and GAO audits and probes
-- Special projects to further investigate findings from on-site reviews and program assessments
The bottom line
The executive summary concludes that review methods need to be improved to permit better analysis.
"The exercise of collecting and analyzing data on deficiency rates raises questions about the appropriate review methods for the future," the summary states. "Plant reviews that generate lists of deficiencies are not useful in drawing conclusions or in answering questions concerning what the findings mean."
Deficiency lists also raise difficult questions such as the safety of food produced under certain "deficient" conditions, and the number and type of deficiencies that can be allowed to occur on a repetitive basis. R&A is currently exploring new review methods with the objectives of:
-- Improving FSIS' ability to move beyond listing what problems exist and assess why they exist
-- Improving FSIS' ability to audit industry control systems and assess the level of protection provided
As a result of the review, FSIS has proposed regulations to require plants to develop and follow Standard Operating Procedures (SOPs) for sanitation.
"Sanitation SOPs are proposed as part of the HACCP (Hazard Analysis and Critical Control Point proposal) and pathogen reduction rule-making, and would provide a structured approach for plants to assure sanitary practices and for FSIS to monitor compliance," according to the executive summary.
FSIS is currently testing revised review methods based on the knowledge gained from this review. These revised methods allow measurement of the extent to which plants systematically prevent unsanitary practices and related food-safety hazards.