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From: Food Quality & Safety magazine, December/January 2009

HACCP Programs and Practices Evolve

HACCP plans should be subject to regular revision

by Pascal Yvon, PharmD

Editor’s Note: This article is based on three webinars from The Microbiology Webinar Series, co-sponsored by AES-Chemunex, Inc. and Carpe Diem, A Wiley Company. Donald Schaffner, PhD, professor and extension specialist at Rutgers University’s School of Biological and Environmental Sciences, was the keynote speaker for both “Challenges in Implementing HACCP: Validation and Verification, Quantitative Risk Assessment: Is it the Next Step After HACCP?” and “Use of Predictive Microbiology to Support HACCP Decision Making.” The webinars also featured Pascal Yvon, PharmD, MBA, CEO of AES-Chemunex, Inc., and Rick Biros, publisher of Food Quality. Webinar archives are available at or

The risk of injury due to biological, chemical, and physical hazards in the food supply is a constant one. Food supplies in the United States and the rest of the world are continually challenged by a diverse array of food pathogens, the increasing variety of products and processes, and increased international trade. Even food manufacturers with the best quality assurance programs need to remain vigilant and can be negatively impacted by marketplace issues out of their control, the worst of which is the recall of a product that has caused or is thought to have caused illness or injury to consumers.

Economic losses can be devastating, especially when the exact cause of an outbreak takes weeks or months to pinpoint, as with the Salmonella Saintpaul outbreak early last year. On June 3, 2008, the Food and Drug Administration (FDA) began issuing warnings about the consumption of red round, red Roma, and red plum tomatoes, which were initially thought to be contaminated. It was not until mid to late July that the FDA ultimately determined that jalapeño and Serrano peppers grown, harvested, or packed in Mexico were the source of the contamination.

The Florida Tomato Growers Exchange estimates that U.S. tomato growers and shippers lost $130 to $140 million because of the outbreak. Such potential losses are sure to have companies implementing and updating their Hazard Analysis and Critical Control Points (HACCP) programs. HACCP is a scientific, systematic method of identifying specific hazards using risk assessment techniques throughout our food chain, from raw materials to final products.

Currently, the FDA and the Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) only mandate the use of HACCP programs for the juice, seafood, meat, and poultry processing industries in the United States. Failure to comply can result in a number of penalties, including legal action by the regulatory agencies. Although HACCP is vol- untary for all other food industries, it is certainly a priority for companies interested in protecting the food supply, public health, and their own reputations.

According to Donald W. Schaffner, PhD, a professor and extension specialist at the Rutgers University School of Biological and Environmental Sciences, quality assurance or quality control (QA/QC) departments should consider implementing a HACCP plan. Companies with a HACCP plan already in place should consider it flexible and subject to regular revision, so that they can anticipate and adapt to changes in the marketplace.

“QA/QC managers must continually think about unexpected threats, alternate procedures, new technologies, and other strategies to safeguard quality,” said Dr. Schaffner. “The challenge in implementing an effective HACCP plan, however, is to make sure it can withstand the test of validation and verification. Verification asks ‘Are you following the HACCP plan?’ Validation answers the question, ‘Will the plan work if you follow it correctly?’”

Validation and Verification

“We need to be concerned with validation and verification to make sure the HACCP plan is accurate and being implemented properly,” Dr. Schaffner added. “For example, if a HACCP plan says ‘Cook a product to at least 160ºF,’ and product is cooked to 161ºF, implementation of the HACCP plan has been verified.

If the plan says ‘Cook to at least 160ºF,’ and the product is cooked only to 159ºF, the plan is not verified and has not been implemented properly. If the plan says ‘Refrigerate a product to 45ºF to control Salmonella growth,’ this is valid for Salmonella control. However, if the plan says ‘refrigerate to 45ºF to control Listeria growth,’ this is invalid for Listeria control—since Listeria actually grows at 45°F—so the HACCP plan is not valid.”

When verifying a HACCP plan, there are a number of important questions to consider:

  • Are the critical control points (CCPs) in control and effective?
  • Is the HACCP system operating according to the HACCP plan?
  • Is the company complying with any required regulatory verification?
  • Has the company validated that the HACCP plan and all components are adequate to control hazards?

“If deficiencies are found, you will need to adjust the plan. For example, if you have too many CCPs, this can make it virtually impossible to implement the plan, and it should be adjusted accordingly,” Dr. Schaffner said.

Blake Christy, general manager of Buona Vita, Inc. (Bridgeton, N.J.), says he is constantly evaluating his HACCP plan. His company makes ready-to-eat meat products, including meatballs, meat loaf, sausages, and pizza toppings. When Christy joined Buona Vita 20 years ago, he brought with him a strong interest in food safety that came from his background in medical science.

“My HACCP program is morphed all the time—it’s a moving target. Something could change at any time, so it needs to be looked at constantly,” said Christy. His overall HACCP program is supervised by the head of QC and includes eight to 10 individual HACCP plans for various products and procedures.

“Plus, we are always looking at how food safety affects food quality. It’s a fine line,” said Christy, who likes to set his standards higher than USDA requirements in order to allow for slight deviations. “If the USDA requires us to cook our meatballs to 155°F, I set our internal standard to 160. This ensures safety without compromising quality,” he added.

“In addition to updating the HACCP program whenever a new procedure or system is put in place, we conduct an annual review or revalidation. This includes talking with other people in the plant, like maintenance workers, shipping and receiving, workers from all three shifts. They can give us valuable information about potential cross contamination, because we sometimes don’t always see what is going on.” Christy’s revalidation typically takes about a week.

U.S. regulations require revalidation (or reassessment) at least annually or whenever any changes occur that could affect the accuracy of the hazard analysis or the effectiveness of the HACCP plan. Some changes that impact microbial risk and may trigger reassessment include:

  • Using new raw materials/ingredients or new suppliers;
  • Different product formulation (e.g., viscosity, water activity, pH);
  • New processing methods and/or packaging materials;
  • Significant increase in production volume;
  • Changes to the finished product distribution system;
  • HACCP plan is found inadequate;
  • Compliance to plan is difficult;
  • New pathogen or foodborne disease linked to product;
  • Recalls of similar foods from competitors; and
  • Customer complaints.

“When reviewing your HACCP plan, you need to ask ‘Are you accomplishing what you need to accomplish?’ When answering, critically evaluate what is working and not working, then document your findings in a report and implement appropriate changes,” said Dr. Schaffner. He suggests reviewing all audit reports, reviewing the hazard analysis, identifying new potential hazards, evaluating the HACCP plan’s effectiveness against new hazards, and verifying CCPs.

Random Assessments

Random USDA inspections or assessments make sure that food manufacturers are complying with government regulations and industry standards. “The USDA is in our plant right now conducting a comprehensive food safety assessment,” Christy said. “I welcome it; it’s like a free audit that will make us a stronger, safer facility.”

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.

“The final step, risk characterization, is the component that risk managers will use to inform their decisions, so it is critical that the preceding components—hazard identification, exposure analysis, and dose response analysis, if included—be completed with the highest accuracy and diligence,” he added.

Christy’s current HACCP plan has some elements of QRA, because he has always strived to be ahead of the curve when implementing food safety procedures. When he first got into the food business, Christy began to read up on the Code of Federal Regulations and started to develop his own internal food safety program. “When the HACCP regulations were implemented, we already had our framework in place, it was just random. We had the pieces to the puzzle; we just had to put it into a plan. Many small companies thought HACCP would be just a new road bump regulation like wearing a hairnet or gloves. They didn’t realize it would be a new global approach to handling food products,” said Christy.

“Even today, many new, smaller food companies don’t realize it’s not enough to have a great recipe. That’s the easy part of the business. Food safety is the critical part of the business,” added Christy, who often directs new companies to use the USDA-FSIS Web site ( “Food safety can be a very confusing thing, but it doesn’t need to be. The FSIS Web site has excellent templates and is a valuable tool for setting up a HACCP framework.”

Predictive Microbiology and Modeling

Further supporting HACCP decision-making and risk evaluation, predictive microbiology/modeling is an emerging tool for protecting the integrity of the food supply. It uses mathematical models or equations that predict behaviors of foodborne microorganisms when exposed to different environments, taking into account temperature, water activity, pH, and so on. Models can be used to estimate microbial growth, inactivation, or survival in culture media or food products.

“Models for inactivation have been around for almost a century, dating back to the development of the ‘12 D bot cook’ used to assure the safety of canned foods. Models for growth and survival, on the other hand, have been available for about 20 years,” Dr. Schaffner said.

Commonly used modeling tools include the USDA Agricultural Research Service’s predictive modeling program and the predictive modeling information portal, the ComBase predictor developed by the Institute for Food Research, and the American Meat Institute’s integrated lethality spreadsheet.

“USDA-FSIS recognizes the benefits of using predictive modeling, but it recognizes there are some drawbacks: Models may not reflect all variables, may not include the effect of natural flora, usually do not account for the effects of heat shock and adaptation of microorganisms, and model variability may not be known or not correct,” said Dr. Schaffner. “While the FDA does not have a formal policy, it has an extensive history of model use for thermal processing of LACF [low acid canned foods]. Also, FDA has used and is using modeling to make other policy decisions.”

Recognized by many national governments and the Codex Alimentarius, the HACCP system has become a principal food safety program around the world, particularly during the past decade. HACCP’s preventative approach to food safety makes it especially appealing; companies need to implement all prudent strategies that protect reputations, public health, and their bottom lines.

New techniques such as predictive microbiology and QRA will support the further implementation of HACCP by improving HACCP decision making. Informal polling of webinar attendees supports this belief. Half of webinar attendees who responded to polls during the events said that companies in their industry were starting to use or already regularly use predictive modeling, and 66% of the respondents said they planned to learn more about predictive modeling. The majority indicated that microbial modeling and quantitative risk assessment were relevant to their industry, with 48% saying it was very important, 24% saying it was somewhat important, and 26% saying it was something to consider for the future.

Dr. Yvon is the CEO of AES-Chemunex, Inc. Reach him at



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