HACCP Programs and Practices Evolve

A new HACCP procedure is already in development at Christy’s plant as a result of this assessment. Buona Vita’s production process involves freezing the meatballs, packaging them, and placing them in cold storage. The current QC procedure is to have 24/7 electronic monitoring of the freezer. Phone alerts are sent if there are any deviations. In addition, twice a day, a QC person uses an infrared thermometer to take the temperature of a beam in the cold storage freezer, the floor, and a corrugated box containing product.

“During our assessment, the USDA asked, ‘How do you know the product is frozen?’ Common sense would suggest the meatballs are frozen if everything else is, but a HACCP plan needs to be bulletproof. We need to be able to validate that the meatballs are frozen to the correct temperature,” Christy said.

“Immediately, we added two new probes, one to monitor the air and one to stick into a meatball. We’ll do this daily for the next year and compare the results of the two new probes to our temperature readings for the beam, floor, and boxes. Working with the USDA, we hope to be able to validate that taking the temperature of the beam, floor, and boxes proves that the meatballs are frozen. Long term, we hope we won’t have to stick probes in meatballs daily,” Christy added.

Quantitative Risk Assessment

In the mid-1990s, some food microbiologists decided to go beyond HACCP and began applying risk assessment techniques for evaluating microbial risks to food. The process is still evolving, but the three primary components are:

• Quantitative risk assessment: This is a scientific process that asks how big the risk is and what factors control it.
• Risk communications: This is a social and psychological process that asks how you can talk about the risk with affected individuals, whether industry, government, or consumers.
• Risk management: This is a political process that asks what can be done about the risk.

All three components enable risk managers to determine acceptable levels of risk. Quantitative risk assessment has four key areas of analysis:

• Hazard identification: What microbe, food(s), and people are involved?
• Exposure assessment: What is the chance of exposure? How many cells will people be exposed to?
• Dose-response assessment: What is the human health effect of the exposure?
• Risk characterization: What is the complete picture of the assessed risk?

“During hazard identification, you want to link epidemiological data, what foods typically carry what pathogens which typically cause what illnesses in humans. You want to consider the impact on susceptible subpopulations: children, [the] elderly, pregnant women. What are the acute and/or chronic complications? What are the characteristics of the organism—spores, vegetative cells? Does the organism cause disease by infection or production of a toxin?” Dr. Schaffner said.

According to Dr. Schaffner, exposure analysis estimates the likelihood a pathogen might be consumed and what amount/dose will cause illness. Unlike a simple growth model that provides a simple point estimate, quantitative risk assessment uses Monte Carlo simulation. This technique uses variable numbers or random simulation like a roulette wheel. In a simple example, the initial number of organisms follows a Poisson distribution , the growth rate is normally distributed, and the product composition and storage temperature are fixed. Corporate risk managers can use the quantitative risk assessment (QRA) output as an aid to determining acceptable product shelf life.

Dose response analysis is an important part of government risk assessment, which translates exposure analysis output into a measure of human health. “Typically, the food industry completes an exposure assessment but does not do the dose response assessment. For the few companies starting to do dose response, they must consider its many caveats and limitations, especially relating to old data sets,” said Dr. Schaffner.