Use of Microbial Data for Hazard Analysis and Critical Control Point Verification—Food and Drug Administration Perspective

Abstract

This paper examines the role that the microbiologist and microbiological testing play in implementing hazard analysis and critical control point (HACCP) programs. HACCP offers a more comprehensive and science-based alternative for controlling food safety hazards compared with traditional sanitation programs based upon good manufacturing practices. Controlling hazards under an HACCP program requires a systematic assemblage of reliable data relating to the occurrence, elimination, prevention, and reduction of hazards. These data need to be developed in a transparent environment that will ensure that the best scientific methodologies have been employed in developing the needed data. The two mechanisms used in HACCP to assess the adequacy of the database are validation studies and the verification assessments. Microbiological testing is an important mechanism for collecting data used in developing and implementing an HACCP plan. Microbial sample data can help establish standard operating procedures (SOPs) for sanitation, assess the likelihood of the occurrence of hazards, establish critical limits, and assess the validity of the HACCP plan. The use of a performance standard to assess whether microbiological hazards have been reduced to an acceptable level creates an especially important use for microbial analysis. Microbial testing is also useful in implementing an HACCP plan by helping to monitor the effectiveness of sanitation SOPs, the compliance of incoming ingredients with safety criteria, the safety of product being held for corrective action, and the safety of the finished product. The verification audits demonstrate that all control measures have been applied as designed in the HACCP plan. Although auditing HACCP records is the primary means of verification, microbial sampling can play an important role as well.

The establishment of critical control points at the washing and air chilling stages in poultry meat production using multivariate statistics

“…There are several uses of the microbiological testing in HACCP systems: prerequisite programs, assessment and monitoring of critical control points, validation and verification (Kvenberg & Schwalm, 2000). Poultry carcasses usually have very high levels of contamination on the skin.…”

Effectiveness and performance of HACCP-based programs

“…Proponents of the former ''inspect as you go'' approach argue that some form of product monitoring is still required to verify the implementation of HACCP-based programs (Allen, 2001;Kvenberg & Schwalm, 2000). Audits which include a visit to the facility and review of records can only confirm that the procedures and processes of the manufacturing system are being implemented as planned.…”

Global biosecurity in a complex, dynamic world

“…In response to the growing need for better food surveillance, the FDA implemented the hazard analysis and critical control point (HACCP) program for prevention of food-borne diseases, which involves monitoring food distribution at critical control points where contamination is most likely to occur [103,104]. In 2005 the Food Safety and Inspection Service (FSIS) of the USDA established the Food Emergency Response Network (FERN), which will work with the FDA and its HACCP program to integrate a laboratory network across the U.S. that can quickly respond to food-related emergencies [105].…”