The FSMA focuses on prevention of food contamination as the first line of defense against food safety hazards. The Act requires that virtually all food processors, manufacturers, and packers analyze hazards and adopt risk-based preventive controls to manage product safety. Prior to the Act, such preventive controls were only required for juice, seafood, meat, and poultry under Hazard Analysis and Critical Control Points (HACCP) regulations, though many other firms follow its principles in their operations.

HACCP is a quality management system that looks at the operation as a whole. In an HACCP plan, firms must identify potential food safety hazards and where they might arise in their operation. Firms then must develop plans for monitoring these “critical control points” and responding if hazards are detected. HACCP plans also require a recordkeeping system to assist firms and inspectors in verifying that the system is under control. FDA is in the process of defining what will be required under the FSMA.

USDA’s Food Safety and Inspection Service (FSIS) issued one of the first U.S. HACCP rules in 1996. ERS research on the meat and poultry industries’ experience with these HACCP regulations may provide useful insights for FDA and industry. USDA’s regulations kept some conventional proscriptive sanitation and process requirements, such as proper hand-washing procedures and temperature controls, in effect along with the new, more flexible HACCP requirements.

Based on results from a 2002 nationwide survey and FSIS Salmonella product testing data, ERS researchers found that conventional proscriptive requirements were responsible for only a third of the decrease in positive pathogen test samples. Managerial decisions to invest in human and physical capital, food safety technology, and changes in firm organizational structure were responsible for the remainder.

These management decisions were influenced both by HACCP requirements and market forces. Nearly half the Salmonella reduction was tied to direct contractual relationships in which suppliers were paid a price premium, given a guaranteed quantity agreement, or provided other incentives for paying more attention to food safety. The study’s results suggest that HACCP is a more effective means of improving food safety than conventional proscriptive requirements.

Concern about potential impacts on small firms played a large role in congressional debates over the FSMA. In the ERS study of USDA’s HACCP rules, small plants producing specialty meat products had higher average HACCP-related costs than large plants producing commodity products. However, the study suggests that the costs to small firms would have been even higher if FSIS had specified fixed expenditures rather than allowed plants flexibility in creating their own HACCP plans.