Robert B. Gravani, Ph.D.

The Application of HACCP Principles in the Development of New Food Products

FoodTechSource: HACCP is certainly an area of growing importance.

Robert Gravani, Ph.D.: Especially with all the outbreaks and the recalls we have been experiencing in the past ten years. It has really heightened people’s interest in the whole area. We have a really interesting team here at Cornell: a good basic research team, and groups like mine working out in the industry. Our goal is to share information and prevent problems from occurring, to provide the food industry with facts and perspectives on new technologies and the way things might be done differently to reduce the risk of foodborne illnesses and food contamination.

FTS: One of your specialties is developing and implementing HACCP plans during new product development. Is this to create foods that are inherently safer? Or to develop a safer R&D program?

Gravani: A little of both. The way HACCP works is there are seven basic principles involved. It is a management tool designed to build safety into the product and the process by which it is produced. So most of the time there is an existing product and an existing process. A HACCP team composed of people in production and sanitation and food microbiology and engineering—people who have broad and generous knowledge in certain areas of the processing environment and the basic sciences that go along with it—sit down and figure out exactly what the hazards are for a particular product and a particular process, and develop a plan which attempts to eliminate those hazards. HACCP is very product and process specific so even though there might be some generic plans out there that may give you some indication of what you might want to look for, each product or process is different, and these principles need to be really applied each time for each product or process.

FTS: That’s what the team does?

Gravani: Right. They identify the hazards that are involved in producing a product, then look at whether these hazards are reasonably likely to occur and cause an illness. Then they identify points in the process that could control these hazards, and then go through a series of other steps to make sure they are monitored and the boundaries of safety that are assigned are actually met and so forth.

FTS: Can you walk us through the process as it would apply to product development?

Gravani: Sure. While HACCP is applied generally to existing products, it can also be very nicely applied to the product development process. As R&D scientists are conceptualizing and formulating a new product, they can begin to say, “Well, what are the hazards involved with this particular product and the process by which we think we are going to produce it?” Then they begin to apply the steps during the conceptualization of what they think the processing will entail. That’s really important because it can alter the way they may want to produce the product. People have different views of what steps are involved in the product development process. Applying HACCP during product development helps with risk assessment.

FTS: So, the first part of the R&D process would be to develop principles for that process?

Gravani: The seven principles of HACCP are pretty well set down, So what we want to do is apply those principles to the product development process. In other words, as the new product is being developed, people are assessing raw ingredients and they’re putting them together in various shapes and forms; that they could impact food safety. For example, the ingredients they’re adding, could potentially eliminate a hazard—I’m thinking now of what’s called “hurdle technologies”—you might want to add a microbial inhibitor; you might have a product that’s acidic, so that’s going to provide another barrier; you might have a product that has low water activity that would prevent some other organisms from growing. So in other words, as you are going through the process of developing this product you are applying certain principles of microbiology to reduce the risk of certain problems while at the same time looking at how to apply the HACCP principles—particularly in hazard analysis...what hazards might be inherent in ingredient X or Y or Z, and how to reduce the risk of those ingredients, let’s say. Or, what process step are we going to use to knock off or kill the organisms that may be present—those kinds of things. It’s just applying the concept of HACCP early in the process, while the conceptualization is being developed for that particular product.

“By applying
HACCP early on
you can cure
problems that,
after you buy
millions of
dollars worth of equipment, may be expensive
to fix.”

FTS: What are the benefits of doing it this way?

Gravani: Well, certainly your whole team is involved in the process and hopefully you can address some of the microbiological or chemical or physical concerns at that point. And you might be able to take some steps early on to change an ingredient or add a kill step or add an additive that would provide another hurdle. You are taking care of a situation as it develops instead of trying to figure out what to do after you’ve got this product in your hand. It’s very proactive. That’s the whole idea: that HACCP is proactive systematic. By being up front and early in the development of a product you can cure some of these issues that after you build the plant and buy millions of dollars worth of equipment may be expensive to fix.

FTS: Just to clarify, HACCP is not mandatory throughout the entire food industry, correct?

Gravani: That’s right. The FDA has seafood HACCP regulations. And the USDA has a meat and poultry HACCP regulations. And the FDA is formulating some fruit juice HACCP regulations, but those are in the works. So, there’s two formal and one on the way. But for other segments of the food industry there is no mandatory HACCP requirement or regulation. Although many companies in the food industry are using HACCP now as a food safety assurance technique. And there are food service establishments and retail food stores who have very actively engaged HACCP plans in place.

FTS: Do you need to develop a HACCP plan and present it to the FDA prior to going to market with the product?

Gravani: HACCP plans aren’t approved by the agency. But basically what has to happen is there’s a training component in both of those regulations: a company needs to have one person who’s been through an approved certified training program so they understand the principles and can sit down and develop a reasonable HACCP plan. And that seems to be working reasonably well. So that person, in the case of meat and poultry and in the case of most certified programs, gets three days of intensive education so that they learn how to develop a HACCP plan, then they go back and work on it for their particular operation.

FTS: If you are not under mandatory HACCP you do not need to develop one, though, right?

Gravani: Correct. But most people know that it’s the right thing to do so they’re moving in that direction. It’s also the most current state-of-the-art system we have for preventing illnesses and injuries in food product. So what’s happening out there now...let’s say I make an ingredient for a company. That company is going to require me to have a HACCP plan just because they want to be sure my ingredient is being produced and processed under conditions that would render it safe and wholesome. So in many segments of the industry, in a voluntary sense, buyers are requiring their suppliers to have HACCP plans. The HACCP system is being pushed back in the food chain so that suppliers of ingredients have HACCP plans, and their suppliers of packaging materials, etc., have plans, We’re seeing a good part of the food industry moving in that direction to ensure safety.

FTS: How much does a supplier need to reveal?

Gravani: Many of the larger companies are going to what’s called the select supplier system. In other words, instead of buying products on the spot market where their purchasing folks buy based on price, a lot of the science and R&D people are saying look, we’d rather pay a little bit higher price if we can be assured of consistently high microbiological quality. So, in a select supplier program they will say to one or two suppliers, look we’ll give you X percent of our business if you can deliver this consistently. And they know the quality level because they go out and do third-party audits of plants, check product in a random fashion to determine whether or not its meeting specifications, and they select the suppliers they have the most confidence in. And I think it behooves both buyers and sellers to think about this kind of system; certainly, those suppliers who can’t comply, I’m not sure I want to deal with. The price of safety is certainly worth paying.

FTS: It avoids lawsuits.

Gravani: Sure. On the other hand I don’t know anyone who goes to work every morning saying, “gee I wonder how many people I can poison today.” They work very hard at preventing these kinds of problems.

FTS: For major companies who are not required to have HACCP, what made them begin to require it internally?

“In many
segments
of the industry,
buyers are now
requiring their
ingredients
suppliers
to have
HACCP plans.”

Gravani: Sometimes we forget, but HACCP was invented by industry. It’s something the Pilsbury company did in the late 1960s for a NASA grant to provide safe foods for space travel. In the early ’70s when it was presented to the industry, the FDA said hey that sounds like a good idea, let’s apply this to low acid can food products. And they actually contracted with Pilsbury to perform training of the FDA inspectors so they’d learn more about the technology and the techniques. It evolved from there. In 1985 the National Academy of Sciences published a book affectionately known as the Green Book which really addressed the whole issue of traditional inspections, quality assurance, quality control, etc. It looked at HACCP and found it to be a very unique approach in that it provides much better assurance of safety than traditional quality control techniques. And with that, the Pilsburys of the world were ready to embrace HACCP. It got people thinking of it in a slightly different way. Now, when people come to my courses, I say why are you here and they say, the people we sell to say they’re going to come in and audit us to make sure we have a bona fide HACCP plan that works.

FTS: Where do you go to get certified?

Gravani: There is an international HACCP alliance out of Texas A&M University made up of a board and a number of people from various segments of the industry. They have put together guidelines for certification. And what they do is certify both instructors and courses. So the proposed course must go through a peer review to ensure it meets certain HACCP standards. I happen to be a reviewer also, so I see lots of proposed courses coming across my desk and those that don’t meet the requirements get rejected. So that’s how you become a certified course. Then instructors need to go through a training program, have experience, so on and so forth.

FTS: How long does it take to become certified?

Gravani: It’s just one course. Three days.

FTS: What is the most important part of a HACCP plan?

Gravani: The most important pieces are the early principles: HACCP Principles 1, 2, and 3 are the ones you want to look after in the product development process. As you look at product design, certainly Principle 1, regarding hazard analysis, is a very important component of product design. When you look at Principle 2 on identifying critical control points—that’s also a piece of the product design as well as a piece of the process control. The same is true for critical limits, Principle 3 of HACCP. It’s partially related to product design while being an equally important component of process control. Then as you get into Principles 4 and 5 there’s less emphasis on product design and more emphasis on process control. Certainly the verification and record keeping is almost totally process control. So, really, the hazards and the critical control points and critical limits are the three key areas related to the design of the product.
   That’s how you begin to look at it. You say, What hazards would be present in this product flow diagram I’ve created as I developed my product. Then you begin to determine whether those hazards are really likely to occur in the finished product.

FTS: Is HACCP evolving as advancements are made in food technology and safe ingredients, etc.?

Gravani: Yes. One of the keys of HACCP is that it is an evolutionary process. Just go back to look at HACCP in the early ’70s; there were basically three principles. Now there are seven. Why? because as people began implementing this system they realized there needed to be more things coming into place to address the hazards and the controls. There are a lot of new technologies out there. We’re looking at risk assessments, microbiological modeling... There are new processing technologies, like pulsive light and high pressure processing, which have some interesting ramifications for product quality and safety. Certainly some prerequisite programs—which take place outside of the HACCP plan that could reduce conditions in the plant that might support growth of organisms—are certainly being looked at. Ozonation of water in various processing operations, along with other intervention strategies, are being actively researched to see if they have any potential merit for incorporation into a variety of processes.

FTS: If there’s more HACCP, why are we seeing more outbreaks?

Gravani: HACCP is an interesting concept. We can prevent known hazards; we cannot protect against unknown threats. HACCP reduces the risk of illness or injury, it does not eliminate the risk. Plus, most of the problems we are seeing with Listeria, for instance, in processed meat products...we know how to kill this organism, that’s not the problem. The problem occurs between the process and the package, usually for a variety of reasons. This organism is present on condensate, it’s present on pieces of equipment, it can develop in nooks and crannies, it can be aerosolized by high pressure hoses in the plants...you can spread it around, and what we need to do to reduce the problems is implement very strong proactive cleaning and sanitizing programs. Those kinds of things are very important. HACCP is a good system, it just needs to be addressed properly. You need to have good prerequisite programs done on a daily basis outside the HACCP plan to make sure the plant facility and sanitary design, the product flow through the plant, etc,. is really taken into account and monitored carefully.

FTS: When developing a new product, do you design HACCP around the plant as well? Is it plant-specific?

Gravani: It’s product and process specific: you address it line by line, product by product, plant by plant. You might have a huge processing plant producing dozens of different products, with each one having its own HACCP plan. Some of these products are going to be line extensions: a different flavor or a different color; That’s okay as long as that new ingredient doesn’t introduce any unique hazards into this situation. You can lump plans as long as they’re like. But if there’s any new hazards that might crop up, you’ve got to address those in the HACCP plan.

FTS: Do you need separate plans for separate plants?

Gravani: That depends. Is the process exactly the same? That’s one of the things you look at. Let’s suppose a large bakery has a different type of oven or a different type of conveyor system than a smaller operation producing the same product; those have to be taken into consideration. They may indeed be the same but they may indeed be different depending upon the specific process. Any time you change something you want to go reevaluate the HACCP plan.

FTS: So, you need to take the plant facilities into consideration?

Gravani: Absolutely. One of the things you do after you form your HACCP team is you begin to talk about the specifics of the product: sensitive ingredients, how is it going to be distributed, who is it going to be distributed to...you also then develop a flow diagram of how the process goes from essentially raw ingredients to finished product. And then you go verify that flow diagram in the plant. And that becomes the basis for your hazard analysis. So you do all these things before you get to the seven principles. And that’s important. Students always want to run and talk about which points in the process are critical control points. But the most important principle is the first one, and that’s conduct a hazard analysis. Because if you don’t identify a hazard that exists in that product process, guess what, you’re not going to protect against it.

“HACCP is product and process specific: you address it line
by line,
product
by product,
plant
by plant.”

FTS: How much of this is looking at how the product is going to be stored or what could possibly happen, like people eating uncooked hotdogs that were meant to be cooked first...

Gravani: That’s why we have user instructions on packages, why we have “use by” dates, etc.

FTS: Is misuse figured in?

Gravani: Well, it’s important that your label have proper instructions on it. The label has to be thorough, and contain refrigeration requirements, and the cook thoroughly requirements, and it must list any ingredients that might be of interest to sensitive individuals.

FTS: Is labeling part of HACCP?

Gravani: Certainly allergen control could be part of a HACCP plan or part of a prerequisite program, depending upon how a company views it. The labeling issue, especially in a plant that makes multiple products, some that contain allergens, is important. And again, if a HACCP team sits down and decides that the labeling step is critical to the safety of their product, they address it as a critical control point and they have to follow up and make sure that they are meeting the boundaries of safety that they set up for that particular point.

FTS: What ultimately do you see as the future of HACCP?

Gravani: Certainly I see the globalization of HACCP. Any country that wants to trade food across borders is certainly going to need to be actively involved in HACCP. We see that happening now. There are HACCP courses held literally around the world because companies and countries are realizing that’s an important parameter. Nobody wants to trade an unsafe food. I also see a movement toward voluntary implementation of HACCP throughout the food system. I see it being moved back down the system from buyers to suppliers. I see impetus now, given the produce problems that have been in the news the last few years, in packing houses developing HACCP. And I think many of the larger companies are moving toward a next generation HACCP, trying to improve it.

FTS: Is irradiation likely to impact HACCP? Are companies going to be less interested in sanitation prior to the irradiation kill step?

Gravani: I certainly hope not. Because the key to sanitation are the prerequisite programs, which are very extensive. They deal with things like raw materials control and sanitation in general—plant hygiene—standard procedures for received product, how they’re handled, and at what temperature they’re stored. Then you’ve got production controls; calibration programs for various warmers or coolers and any piece of equipment that needs to be calibrated. You’ve got production zone controls, metal control programs, glass control programs if you’re packaging, allergen control programs, chemical control programs—do you have cleaners and sanitizers in the plant? Then you look at the production equipment and sanitary design of equipment, traffic flow of people: can they go from the finished side to the raw side and back again—cross contamination? Then finally you look at all your distribution and transportation issues, what happens with storage after it’s processed; where does it go; how clean are the delivery trucks.You also have to consider crisis management plans; are recall plans in place and ready to go? How are consumer complaints followed up? And again this is a very thumbnail sketch. But all those are considered prerequisite to HACCP. So those need to be dealt with: environmental and operational conditions within the plant need to be addressed on a daily basis, some of which may be part of a company’s HACCP plan. An that’s the foundation on which it is built.
   In the early ’90s they developed a little model and you picture this as a pyramid with the foundation being all these prerequisite programs. Then the top piece being total management commitment, the lower left quadrant a very good working knowledge of biological chemical and physical hazards, the little triangle on the right would be a very effective training and education program for hourly employees, managers and light supervisors, and the triangle in the center is all the HACCP principles. Basically everybody needs to have all those components going for the process to work properly. And it’s all built on the strong foundation of these prerequisite programs.
   I like to use the analogy that it’s like building a skyscraper on the surface of a swamp. If you don’t have a good foundation of prerequisite programs, HACCP isn’t going to work. It’s going to fail. So you need to address those prerequisite programs first. And as you go you need to assess their success and say, hey, here’s a couple of areas we need to tighten up. Then you go in and apply HACCP. And then it works.
   Make sense to you?

FTS: When you put it that way...