This year marks 25 years since FSIS issued its landmark final rule, “Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP),” issued in the summer of 1996.

“Food safety is an ever-evolving process,” said FSIS Administrator Paul Kiecker, who began his agency career as an inspector in a food processing establishment. “HACCP marked a dramatic change in food safety and how FSIS approached its mission of keeping food safe and role of inspecting processing establishments,” said Kiecker.

The PR/HACCP rule was designed to reduce the occurrence and numbers of pathogenic microorganisms, harmful bacterial, on meat and poultry products, reduce the incidence of foodborne illness associated with the consumption of meat and poultry products, and provide a new framework for modernization of the current system of meat and poultry inspection. The HACCP and sanitation requirements in the PR/HACCP final rule were partly motivated by the agency’s desire to better address the problem of harmful bacteria on raw meat and poultry products. Such bacteria, including Salmonella and E. coli O157:H7, were and are significant food safety hazards associated with meat and poultry products.

In 1993, the pathogens and outbreaks issue came to a head amidst an outbreak of E. coli O157:H7 that traced back to ground beef sold at a fast-food franchise (Jack in the Box) in the Pacific Northwest. In that outbreak, the pathogens led to the deaths of four children and serious lasting health issues for nearly 200 other consumers, the majority of whom were younger than 10 years old. The agency was already in the process of developing regulations to require HACCP at FSIS-inspected meat and poultry processing establishments. The regulations would require a systematic approach to food safety — identifying in food production and using preventative measures to avoid those hazards that could pose potential health risks to consumers.

These changes included requiring each establishment to develop and implement written sanitation standard operating procedures; FSIS established pathogen reduction performance standards for Salmonella, and recordkeeping procedures and requiring establishments to implement preventative food safety measures for their products.

Testing for targeted pathogens is a crucial verification step in assuring that the HACCP plans developed by the plants are working as intended. USDA-FSIS photo.

After the 1993 outbreak, FSIS officials and the public called for a more science-based inspection system, marking a significant shift in regulatory philosophy at USDA. Rather than attempting to only inspect finished products for biological, chemical and physical hazards, the HACCP regulations required establishments to avoid these hazards in the first place, emphasizing the preventative nature of the HACCP approach and policy.

The PR/HACCP final rule also changed and specifically defined the roles of the federal government and establishments in the food safety inspection process. Establishments have more flexibility to innovate and make establishment-specific decisions to improve food safety. Under the previous command-and-control based system, the inspector had responsibility for ‘‘approving’’ production-associated decisions. Under HACCP, industry is fully responsible for production decisions and execution. Under HACCP, FSIS personnel conduct inspection activities to verify that establishments comply with food safety standards, and they uphold a strong enforcement program to address noncompliance.

Paul Wolseley is an executive associate for regulatory operations in the FSIS Office of Field Operations. As one of the original HACCP facilitators with FSIS, he assisted with delivering HACCP training in the late 1990s.

“I had the privilege to see first-hand the most significant change at that time for both FSIS and the industry,” said Wolseley. “By moving away from a command-and-control methodology of conducting inspection to a science-based approach for controlling food safety hazards in meat and poultry products, we greatly enhanced our ability to protect public health,” said Wolseley. “The shift to HACCP paved the way for innovations that continue today.”

Another significant change to FSIS operations is the laboratories and microbial testing programs. Testing targeted pathogens is a crucial verification step in assuring that the HACCP plans developed by the plants are working as intended.

William Shaw is the FSIS executive associate for laboratory services. “The HACCP program was a paradigm shift for the agency,” said Shaw. “The need for verification led to the largest scale microbial testing program by the agency. It’s evolved into the FSIS annual sampling plan we issue today.”

HACCP has been an effective tool in ensuring that our nation’s food is safe. According to one study, Williams and Ebel, 2012, Salmonella contamination on broiler chickens (carcasses) decreased by 56 percent from 1995, before the HACCP final rule was announced, to 2000. The number of foodborne illness cases attributed to Salmonella on broilers was 190,000 lower in 2000 than in 1995.

In the years since 1996, FSIS has escalated its efforts to combat foodborne pathogens like E. coli O157:H7 and Salmonella. FSIS has also updated its HACCP regulations to cover more establishments and food products. In 2020, FSIS amended regulations for egg products inspection, requiring official plants to develop and implement HACCP procedures, bringing them into alignment with requirements for other FSIS-regulated products. “The evolution of our policies and inspection programs means FSIS can be more proactive instead of reactive when it comes to stopping an outbreak,” said Kiecker.

As a result of this evolving landscape, FSIS continues to promote and maintain the highest standards in the food production process and, today, its mission of protecting the public through food safety remains as essential as ever.

 — By Jack Connolly of the Digital And Executive Communications Staff

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