HACCP validation controversy

by Bernard Shire
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Fourteen years ago, the U.S. Dept. of Agriculture's Food Safety and Inspection Service completely revised its meat and poultry inspection requirements, mandating that meat and poultry plants use a Hazard Analysis Critical Control Point (HACCP) system to ensure its products were safe for people to eat. Since then, for the most part, the government inspection agency has dictated minor changes in the way the food safety system should be carried out.

But recently, FSIS has proposed compliance guidelines for meat and poultry processing companies to use to ensure their HACCP plans have been validated to USDA standards. And these are not just changes in how plants can comply with the HACCP regulations. They involve a major re-writing of HACCP, because they change what plants need to do in order to validate their plans, in order to comply with the HACCP regulations. 

Micro testing required 

Under the new proposal, plants, for the most part, will be required to do in-plant microbiological testing as the only way to validate their HACCP plan or plans. The proposed USDA guidelines are creating a major fight between USDA and the meat and poultry processing industry over what industry needs to do to ensure its food safety systems and plans are OK. One source told Meat&Poultry.com the FSIS proposal stems from the agency’s uneasiness with meat and poultry plants blindly following scientific processes for HACCP verification and validation, without understanding how these processes can be proven in their own plants. 

Until now, HACCP plans were validated in two ways: (1) Scientific support for in-plant processes and critical control points addressing the specific hazards in the process; or (2) Demonstrating the safety plan actually works in the plant. But in a letter to nine industry trade associations, FSIS Administrator Alfred Almanza said there is a widespread lack of understanding of HACCP validation that FSIS has found among establishments, whether large or small. He added prerequisite programs, in addition to HACCP itself, must be validated, because these programs are often used by companies supporting the idea a food safety hazard is not likely to occur in the manufacturing process.

In an interview with MEAT&POULTRY.com, David Theno, Ph.D., a food industry consultant, believes plants have the responsibility to verify what’s going on in their production and food safety processes. “I’m one of those people who believe if you, as a processor, are not doing everything you can in terms of best practices, then you shouldn’t be in business anymore,” Theno declares. “This really goes beyond FSIS asking for testing in plants. Plants are going to have to prove what they’re doing microbiologically,” he says. That doesn’t mean on-site laboratories. Theno formerly worked as senior vice president and chief product safety officer for San Diego-based Jack in the Box. Theno was hired by the company in 1993, not long after an E. coli outbreak linked to tainted burgers in some of the chain's stores made hundreds of people sick, and led to the deaths of several children.

“Obviously, they’re not asking people to bring pathogens into plants,” Theno says. “They want you to verify the process you’ve se-lected to ensure your product is safe. USDA wants to have an outside process validation, in an outside laboratory. This means standard microbiological effectiveness. Take the product to a lab, inoculate it. Do total plate counts, total coliforms,” he says.

Processes Meeting FSIS Guidelines Should Not Require Microbiological Testing

Dennis Johnson, an attorney with the Washington, D.C. law firm of Olsson Frank Weda, says in an interview with MEAT&POULTRY.com the disagreement is over whether the plant has documented the HACCP plan is actually working at the establishment. He uses as examples a plant using Appendix A, FSIS guidelines for meeting lethality performance standards as scientific support for its cooking process, which requires cooking at 160 degrees F for 10 seconds. “If that is done, tbe validation would be measuring the tem-perature to demonstrate it consistently meets the temperature in the plant operations. If that happens, there aren’t going to be any pathogens in the product,” Johnson says. “Or Appendix B, compliance guidelines for cooling heat treated meat and poultry products.”

While Johnson believes plants using these FSIS guidelines are not required to develop food safety data (through micro-testing) for valida-tion, Almanza disagrees. He says the guidance would be adopted so the process works “in the establishment’s unique processing environment.” 

Theno agrees using an FSIS recognized process is not enough today. “Say the water you’re using as part of your process isn’t hot enough. Or the concentration of the acetic acid is not correct. How would you know?” he asks. The only way to be sure is by micro-sampling. The proof is not to go back and redo all this science. That’s fine. But the proof in the pudding is what’s happening microbiologi-cally,” he says.

OFW’s Mr. Johnson does not think all of a plant’s incoming raw materials need to be sent to a lab to be tested. “Instead, if processes (like Appendix A or Appendix B) are well recognized, an establishment does not need to conduct micro testing. It can validate with “in-plant observations, measurements, test results or other information,” he says, quoting the HACCP regulation preamble. “As far as whether the plant is achieving what it set out to do, that’s the point of taking the temperatures, cooking the product for the proper time, and that’s what those records are for. If the inspector doesn’t believe what’s in the company measurements and records, that’s a whole other issue, isn’t it? he asks.

Johnson agrees if a new process, a new technology or new application is being used in a plant, more support could be required, and that could include micro testing. “But what’s being asked for under these guidelines is unnecessary, very costly to small and very small plants, and will not result in any greater food safety,” he says.

He believes it was a good idea for FSIS’ Mr. Almanza to submit the HACCP validation guidance material as a draft open to comment. “There will be many comments about this proposal from all the parties dealing with USDA,” he says. Comments will be taken by the agency through June 19.

Bernard Shire is M&P’s Washington correspondent, contributing editor and feature writer based in Lancaster, Pa. With a background in editing and writing for daily news publications, he also works as a food safety consultant and writer for Shire & Associates LLC.

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