September 1, 2004
by Lynn Petrak
Amid security concerns, processors act to ensure overall quality.
If an ounce of prevention is worth a pound of cure, then the dairy industry has long understood the true weight of food safety. From the development of refrigerated transportation to the first pasteurization techniques in the early part of the 20th century to today’s sophisticated system of controls and evaluation, the measures taken by dairy processors have consistently been proactive.
Food safety remains a major top-of-mind issue for dairy industry leaders, farmers, manufacturers, distributors and marketers alike, as well as for government officials, retail and foodservice operators, not to mention consumers themselves. The issues may vary over time, focusing on different pathogens like Salmonella, E. coli and Listeria, and headline-grabbing events like domestic cases of bovine spongiform encephalopathy (BSE). But quality and safety are never very far from the top of the list of processor concerns and investments.
The dairy industry has focused on safety as a priority over the years for a number of reasons, among them the fact that the perishability of its product has always led to a greater scrutiny of its operations. “Fortunately, if there is one thing you can say about dairy, it is that the industry has built so many precautions in its processing and distribution systems that you would be hard-pressed to find another area in the food industry where any more attention is focused on safety,” says Bill Haines, vice president of product innovation for Dairy Management Inc., (DMI), Rosemont, Ill.
Likewise, Cary Frye, vice president
of regulatory affairs for the International Dairy Foods Association (IDFA), Washington, D.C., says collaborative efforts have been effective in the safety area. “My opinion is that the industry has really made great strides. I see more sophisticated systems, I see plants with ISO,” she says. “I see customer and consumer-driven reasons for adding quality parameters and I see more self-audits to ensure that food safety every single day is an important part of the system.”
Dairy processors, who live daily under a host of regulations and standards, agree with the assessment that the industry has been successful because of its commitment to safety. “From a food-safety standpoint, the dairy industry is very regulated and protected. Our view is that everything we do is about the customer — anything that would compromise the customer is at the top of our list of concerns,” says Carl Schroeder, vice president of manufacturing for Maplewood, Minn.-based Schroeder Dairy Co. “We have to work on food safety every day. It is never done and it never ends.”
As Schroeder notes, while there are many firewalls in place in the production and distribution chain to guard against problems ranging from harmful microbes to spoilage, the battle for food safety is far from over. Statistics from the Atlanta, Ga.-based Centers for Disease Control and Prevention (CDC) peg the number of annual food-related illnesses at 76 million, hospitalizations at 325,000 and deaths at 5,000. One of the largest illness outbreaks in U.S. history, still discussed today, is the 1985 incident of Salmonella typhimurium linked to post-pasteurized milk that sickened more than 170,000 people.
Occasional and largely isolated outbreaks still occur, some linked to raw milk and others to other types of dairy products or tied to cross-contamination. Although tainted meat and poultry products have garnered much of the attention and have spurred major recalls over the past decade, dairy products are still considered vulnerable.
Practices Make Perfect
Ironically, while the dairy industry has grown more advanced over the years, technology may have spurred new vulnerabilities. The Food and Drug Administration (FDA), in fact, is currently reviewing good manufacturing practices (GMPs) for food and beverage companies, which were last revised in 1986.
“Since food GMPs are an integral part of the nation’s control over food safety problems, it is essential that they adequately address the needs of today’s food processes and foodborne hazards,” acting FDA commissioner Dr. Lester M. Crawford said in a speech last May. “We believe this effort, like our work on current good manufacturing practices for medical products, will improve the safety of these products and create new opportunities for introducing better manufacturing techniques.”
When the FDA decided to revise GMPs, it assembled a panel of food-safety experts to assess current risks and hazards in the food and beverage industry. In its recently released report, “Good Manufacturing Practices for the 21st Century: Food Processing,” the panel noted refrigerated foods pose some of the highest risks for food safety problems. The experts cited the dairy industry as among the four leading segments facing the greatest food safety issues, with specific concerns relating to training and biofilms.
Currently, dairy industry leaders are submitting comments to the FDA, which is expected to issue final changes on GMPs within a year. For its part, IDFA is assembling a member task force to provide FDA with industry insight and make its own recommendations for any potential changes.
“The industry could see new regulations relating to virtually every aspect of the plant environment, including employee hygiene, process controls and facility maintenance,” says Allen Sayler, senior director of regulatory affairs and international standards for IDFA.
Processors are keeping an eye on FDA’s actions on GMPs as well. Stonyfield Farm, Londonderry, N.H., for example, conducts annual employee training on GMPs and recently began a new audit program, in addition to other proactive activities. “In 2004, Stonyfield Farm created the position of director of corporate and regulatory compliance to serve as the food-safety champion and coach for the company,” adds Alton Bradshaw, who holds that new title and role within the company.
Likewise, Sargento Foods Inc., Plymouth, Wis., recently added a new full-time food safety employee, who monitors GMPs, among other responsibilities. According to Barbara Gannon, vice president of corporate and marketing communications, the new position reflects the company’s overall efforts to deliver on safety. “At Sargento, we design our food-safety practices as a system — all must be in place and working properly to keep risks low,” she says.
Among its recent efforts, Sargento has increased employee training and is now linking GMP audit scores to bonuses.
Among its recent efforts, Sargento has increased employee training and is now linking GMP audit scores to bonuses.
Indeed, the major hallmarks of GMPs — training, audits, documentation and validation/evaluation — are already in place at many dairy plants. “Employee training is critical to the quality of finished products and we are putting more and more emphasis on training and hiring,” reports Schroeder, adding that Schroeder Co. also has updated food-safety practices in conjunction with renovations at its processing facility.
South Burlington, Vt.-based Ben & Jerry’s Homemade Inc., a wholly-owned and autonomous subsidiary of the international firm Unilever, also stresses the principles of GMPs.
“When it comes to food safety we focus on all aspects of public health. We begin with the employees with complete training for personal hygiene and product handling and allergen training and awareness,” says Chrystie Heimert, director of public relations. “GMPs are reviewed and updated as needed when new products and processes are implemented. New equipment, processes, and special ingredient handling requirements will prompt a review to determine if a revision is necessary. We also require all employees to be trained and pass a written exam annually.”
In addition to GMPs, many dairy processors have implemented hazard analysis critical control point (HACCP) programs, which are currently mandatory for juice production but remain voluntary for strictly dairy operations. Still, the program has proven a popular tool in the food safety front; all of the dairy processors mentioned above, for example, have HACCP programs in place, with at least one system dating to 1992.
According to Haines, implementing an official HACCP program is not a big stretch for dairies already running operations under tight controls. “HACCP is already pretty well incorporated in the industry. If you really read the Pasteurized Milk Ordinance (PMO), it really is about HACCP, although they don’t call it that,” he says.
Sayler concurs that HACCP is widely embraced by the industry as part of multi-hurdle approaches to safety. “HACCP itself is nothing new in the dairy industry, but we are seeing more comprehensive implementation. I think it is continuing along because it has proven itself as an excellent system for ensuring and building confidence on food safety,” he says.
Underscoring the importance of the key principles of HACCP, IDFA is continuing its successful certification program, which follows a HACCP model with requirements like written documentation, training and inspections.
To keep up to date on HACCP or to start up a new program, dairies can sign up for various seminars on the topic. At the University of Wisconsin-Madison, for example, the Wisconsin Center for Dairy Research in the school’s food science department conducts annual HACCP workshops. The most recent workshop in July attracted the stated limit of 45 participants.
“I think more and more suppliers are looking to have something in place. If they have one incident, it has repercussions for all of the industry,” says Marianne Smukowski, safety quality applications coordinator for the center, adding that HACCP is now expanding to all sectors of dairy production. “We are seeing more people in the artisan and farmstead type of cheeses who are coming in and taking dairy HACCP programs.”
Likewise, Brian Collis, principal of Collis Consulting Co., Winnipeg, Manitoba, Canada, has seen interest in voluntary HACCP systems steadily grow, both in the United States and north of the border. It is at the point now, he says, that the trend is more about refinements to the program. “What they have been doing in the past, they are now doing better,” Collis says. “What I am seeing are enhancements of the existing base of technology.”
Another trend, Collis says, is the shift toward HACCP as part of broader practices and approaches. “Over the last couple of years, HACCP has been integrated in a total quality management system in some of the bigger companies — it has become a subset of larger management programs,” he explains. “Companies are seeing that HACCP fits nicely in with the whole quality management stream, and are saying, ‘Why don’t we just use this as a reference point to build in other business processes’?”
Tools of the Trade
Within the parameters of GMPs and HACCP — and sometimes beyond them — dairy processors are pursuing and implementing a host of tools to help them in the battle for food safety. Pasteurization remains the most obvious, ubiquitous and venerable weapon in the industry arsenal, eliminating most harmful microbes from raw milk before they get a chance to become problematic.
In addition to pasteurization, sanitation has emerged a key component of safety programs, encompassing measures from clean-in-place equipment features to sophisticated disinfectants. That emphasis is sure to continue, especially in light of FDA’s recent report that listed poor plant and equipment sanitation among the top food safety problems faced by food manufacturers.
Smukowski agrees that sanitation has become a focal point for many in the industry and that technology has spurred strides in that area. “Cleaning and sanitation has always been a big issue, but I am seeing a shift in that it is being done on the first shift rather than the third shift,” she says. “You have more experienced people and more management on first shift.”
In his consulting work with dairies, Collis has also noted sanitation evolving as a cornerstone of safety. “Sanitation and personnel training are the most critical aspect of moving the HACCP system forward and a lot of companies are going in and making those areas better,” he says. “Suppliers are always coming in with innovative ways to try to control environmental contaminants.”
For their part, processors say they understand the significance of sanitation and its role in everyday safety. “Besides actively sharing best practices within the industry, we consider effective equipment sanitation and proper scheduling our most effective defense,” relates Heimert, adding that Ben & Jerry’s typically partners with ingredient suppliers and equipment manufacturers to improve sanitary design.
Schroeder Co. also regularly evaluates the latest sanitation offerings. “We are always looking for ways to improve the environmental conditions,” Schroeder says. “Some examples of measures we have invested in recently include a captive uniform program uniforms, sanitizing sprays in walkways and increased floor, walls and ceiling cleaning.”
Companies that supply equipment and materials for sanitation purposes to dairy companies continually offer new products. Biomist Inc., Park Ridge, Ill., for example, recently launched a new Biomist® Power Disinfecting system that allows operators to power-spray a disinfectant solution of concentrated alcohol, alleviating flammability issues associated traditional alcohol use.
On the equipment side, Sani-Matic Inc., introduced two new cleaning and sanitation systems in 2003, including a multi-tank CIP washer and portable Ultra Flow system that provides faster equipment cleaning and sanitizing; both systems have programmable controls and stainless steel wetted parts. Other innovations focus on the efficacy of sanitation measures. Weber Scientific, Hamilton, N.J., for instance, recently introduced a rapid cleaning validation and sanitation monitoring device called SpotCheck, used to detect invisible glucose and lactose residue on surfaces.
Meanwhile, processors can also work with suppliers on comprehensive programs, such as St. Paul, Minn.-based Ecolab Inc. The company’s integrated “EcoShield” intervention system includes an array of customized tools, such as livestock disease interventions, advanced sanitation technologies, personnel hygiene programs, food surface treatments and food irradiation, depending on the type of operation. Ecolab also provides a complete diagnostic evaluation of a company’s sanitation program.
While keeping things clean is essential in a plant environment, so too is regular testing and evaluation. Over the past several years, dairy processors have increasingly relied on testing to help enhance the safety and quality of their products.
Tests that determine the presence of pathogens have grown more sophisticated over the years, with some results available within hours rather than the previous standard of days. “Rapid testing is big. Companies are doing environmental testing because they want to know right away whether there is any type of problem,” says Smukowski.
According to Haines, DMI has helped sponsor research projects on rapid testing in recent years and may soon evaluate new products along those lines. “There are some companies that have done very well with this technology, for E. coli and other pathogens,” he says, adding with a note of caution, “These rapid methods are useful for monitoring — they raise the red flag — but they may not be for regulatory compliance. You may have to back them up with traditional methods.”
Silliker Laboratories, Homewood, Ill., is one of the largest laboratory services in the country dedicated to food safety and offers the latest testing technology on a variety of fronts for food and beverage processors. In its labs around the country, Silliker regularly tests dairy processor samples for Salmonella, Listeria and other microbes.
Most recently, for the dairy business, the company has been working on new tests used for routine monitoring or when operators suspect a potential problem with their pasteurizing equipment. The current approved test will no longer be valid by FDA standards after October 1.
In its place, Silliker will use a PasLite test developed by Charm Sciences Inc., which detects and quantifies alkaline phosphatase levels for the monitoring of pasteurization processes. That test was selected for use in Silliker’s labs because of its reliability and cost effectiveness, according to Kathy Alamo, operations manager for the company’s Dairy Center in Modesto, Calif.
“We find most of the industry has gone with the Charm PasLite test and we try to work with our clients as much as possible,” Alamo says, adding that the test can be used for quality control as well as a diagnostic tool for detecting potential pasteurization problems.
Other companies have designed advanced detection systems as well. DuPont Qualicon, Wilmington, Del., for example, has added a new Bax® system PCR assay for detecting Enterbacter sakazakii, an emerging pathogen that has been associated with milk-based powdered infant formulas.
Back in the plant, processors also have various testing systems in place. Ben & Jerry’s regularly tests for harmful microorganisms as well as for various allergens, which are an issue in the production of ice cream. “Allergens are monitored with the use of neogen test kits,” Heimert says, “and a well-equipped analytical laboratory verifies ingredients, finished products and any unusual consumer complaints with gas chromatography or other advanced analytical test methods.”
Evaluation and testing aren’t just relegated to the detection of contaminants. Another industry trend relating to safety has been the growing use of third-party audits and evaluations. In fact, periodic audits and inspections of facilities and raw material suppliers are one of the recommendations put forth in FDA’s report on improving GMPs.
Some audits are also tied into the 3-A certification of dairy plant equipment, while others are done as an assurance to a manufacturer’s customers. Through its certification program, IDFA also sponsors checkups of facilities to ensure best practices and proper controls.
Although the use of evaluation has been done for years, there has been a notable shift to the use of outside experts. “In the last 10 years, versus the last 50, processors are using independent sources to do third party audits. It came along with the management of HACCP,” Haines says.
Collis, who conducts on-site audits as part of his consulting work, says that business realities are driving the latest spate of independent evaluations. “The bottom line is that customers are becoming very demanding. Having third-party audits is just a fact of life now,” he says. “Food service and retail companies are saying, ‘If you do business with us, here are some of the conditions you have to meet.’” Ingredient suppliers are also increasingly subject to third party audits, he adds.
Many independent audits focus on recordkeeping, which is another key suggestion in the improvement of best practices espoused by FDA and other safety experts. The recent clamor over BSE affecting the beef industry has focused even more attention on the notion of accurate recordkeeping and, ultimately, traceability throughout the chain.
“It means not only better recordkeeping but that you have a system in place to follow every drop of milk in the system. If there is a problem that appears at the end of the supply chain, you can go back to the cow,” notes Haines, adding that such a task may sound daunting but is realistic. “A lot of that information is in place, it just needs to be linked.”
As processors and industry leaders work on preventative and evaluative measures, they must also keep their eye on emerging challenges. One recent issue is the possibility of a link between Mycobacterium paratubuculoris (MAP) found in post-pasteurized milk and Crohns’s disease in humans.
In an ongoing study, food safety researchers at Marshfield Clinic Laboratory in Marshfield, Wis., have been evaluating samples of whole pasteurized milk for the bacterium as part of their efforts to aid in the development of a rapid detection method for MAP.
It is a topic that industry leaders are tracking closely. “Should there be any evidence that the organism is linked to Crohn’s disease in humans, we would have to be sure that pasteurization would remove it,” Haines says. “To date, research shows that standard pasteurization in the U.S. effectively eliminates MAP in milk, although it is a very difficult organism to work with.”
IDFA also has been involved in ruling out any link, Frye says. “Almost four years ago, IDFA established a paratuberculosis task force, which did initial research,” she says, noting the study was done in conjunction with a leading USDA researcher in Ames, Iowa.
“We went in with a totally open mind,” Frye says. “There is a lot of information and data, but the simple takeaway is that pasteurization as practiced and validated in the U.S. does eliminate MAP from raw liquid milk.” The final results of the study are expected to be published in a peer-reviewed journal this fall.
On the issues-management front, IDFA has also been active working on behalf of the industry with the government on the topic of Listeria monocytogenes.
“We have the final risk assessment that clearly shows some dairy products are high risk and others are low risk. High-risk products will continue to be a focus of regulatory enforcement and testing and we will support that,” notes Frye. “On the other side, IDFA is asking for regulatory action limit for low-risk foods.” In that scenario, she explains, products like hard cheese and ice cream would be evaluated for risk based on a limit of 100 organisms per gram, thus enabling an appraisal by criteria rather than by a category definition.
Meanwhile, although BSE has proven to be more of a beef industry issue, it was a dairy cow that was diagnosed with BSE in Washington state in December 2003, the first case found in the United States. Still, education efforts put forth by industry organizations like IDFA, DMI, the National Milk Producers Federation and the U.S. Dairy Export Council along and individual processing companies, showing that dairy products pose no safety risk to humans, were effective. “When we heard about the diagnosis in December, we put our joint industry crisis management plan into action,” recalls Marci Cleary, IDFA’s senior communications manager. “We went out immediately with information to our members and to dairy farmers and the industry only received a few media calls because we had the message out that milk does not contain or transmit BSE. The answer was definitive and the issue was put to bed.”
Haines concurs. “We had to make sure that it didn’t spill over into the dairy business. We have a good issues response program and linking to state and regional dairy programs gives us tools to get information out in a hurry, whether it’s on safety or economic issues,” he says. “We did get a few calls on BSE but the dairy industry did not seem to suffer any adverse consumer reaction to it.”
As any food or beverage processor knows, issues and crises relating to food safety can crop up virtually any time, which is why programs and tools are in place at various organizations and companies. As Haines points out, the stakes are high when it comes to the safety and security of the food supply: “Maintaining consumer confidence in dairy products is one of five key strategic areas in our organization.” df