Holyfield and De La Hoya move over. This is not your usual heavyweight bout. It’s the food industry versus Listeria monocytogenes, and there’s no room at ringside for those who can’t stomach an all-out brawl.

Although this ubiquitous, foodborne illness-causing patho-gen has emerged as a top concern for most companies in the food manufacturing supply chain, recent regulatory action has centered on manufacturers of certain ready-to-eat (RTE) meat and poultry products, such as hotdogs and deli meats. For these RTE food manufacturers, its gloves-off time.

“If you want to be a contender,” says Michael Cramer, vice president of food safety and quality assurance with Specialty Brands, Inc., the RTE foods manufacturer based in Ontario, CA, “you have to be vigilant. The product has to be safe when it leaves your facility, you can’t expect the consumer to make it safe. If you want to beat Listeria monocytogenes, you’ve got to aggressively put into action a battle plan that includes good sanitation and sanitary equipment and facilities design, multi-hurdle microbial intervention strategies and technology, and a proactive environmental monitoring and testing program.”

This is the winning strategy that Specialty Brands, which manufactures several well-known lines of frozen RTE products—Jose Ole, Posada and Butcher Boy Brands Mexican foods; Rotanelli’s frozen Italian foods; and Fred’s for Starters appetizers—is using to score a KO against Listeria monocytogenes in its six manufacturing plants nationwide. These facilities, located in Riverside, CA; Albuquerque, NM; Lampasas, TX; Carthage, MO; Piedmont, MO; and New Rochelle, NY, manufacture more than 200 million pounds a year of branded and contract private label frozen prepared foods with an emphasis on Mexican, coated appetizers, filled Italian and meat products.

With a state-of-the-art headquarter facility that includes a complete research and development (R&D) center boasting more than 10,000 square feet of laboratory and test kitchen space in Ontario, Specialty Brands also has established dedicated quality assurance (QA) labs in the plants. Each laboratory employs fully trained microbiologists who conduct testing to verify the safety of ingredients, manufacturing environment and finished products.

In addition to operating under strict Hazard Analysis & Critical Control Points (HACCP) plans in which scientific standards are applied to assure critical process controls for potential microbiological, chemical and physical hazards, from ingredient receiving through finished goods shipment, Specialty Brands’ innovative total food protection system also heavily emphasizes sanitation as a key to reducing the potential of the incidence of undesirable microorganisms in its plants or products. Plant environment and equipment are cleaned and sanitized daily following written Standard Sanitation Operating Procedures (SSOPs). Cleanliness is monitored before production using visual evaluation, state-of-the-art bioluminescence technology and generic microbial swabs. Recently, the company introduced an expanded environmental hygiene monitoring and testing program to combat Listeria monocytogenes.

Ready to Rumble
Cramer recently updated Specialty Brands’ program to accommodate new tighter regulations put out by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS). FSIS Directive 10,240.4, Verification Procedures for the Listeria monocytogenes Regulation and Microbial Sampling of Ready-to-Eat Products for the FSIS Verification Testing Program, took effect Oct. 6, 2003. The interim final rule requires manufacturers of medium- and high-risk RTE meat and poultry products to develop written programs to control Listeria monocytogenes and to verify the effectiveness of those programs through testing. The rule establishes three risk-based alternatives for categorizing RTE products and encourages plants to install new technologies to eliminate or reduce the growth of Listeria monocytogenes. The rule also states that establishments must share testing data and plant generated information relevant to their controls with the agency.

The three alternative approaches available to RTE manufacturers include employing a post-lethality treatment and an antimicrobial agent or process (Alternative 1); employing either a post-lethality treatment, or an antimicrobial agent or process (Alternative 2); or employ sanitation measures only (Alternative 3). All of Specialty Brands’ products are rated “Alternative 2” by the company in accordance with FSIS final rule, which means they use an antimicrobial process–freezing– in their product development cycle. However, even with the freezing, which inhibits growth of organisms, Cramer’s goal is zero tolerance for any organisms, which is why he’s implemented such an aggressive environmental monitoring system at the company’s six plants.

“Prevention is the primary means of protecting our products and we have very strict sanitation and Good Manufacturing Practices (GMP) requirements to avoid product contamination. However, detection of this ubiquitous organism is also important. It’s in everyone’s best interest if all ready-to-eat manufacturers implement aggressive testing programs,” he says. The cost of a single Listeria outbreak can be staggering to the company responsible but it also has repercussions across the industry. “Eating habits of consumers change, safety rules are reevaluated, and activist groups push for tighter regulations.”

The FSIS’s ruling caused Cramer to add direct-contact surface testing for Listeria monocytogenes to his already extensive environmental monitoring program. He had avoided direct contact testing in the past, waiting to see what the USDA’s ruling would be, but he’s comfortable with the new regulations. “It’s a fine guideline for food manufacturers,” he says. He’s pleased that the rule gives manufacturers an opportunity to determine if contact surface contamination poses a hazard and to deal with it before a problem occurs.

Cramer likes the scientific approach the rule takes in identifying and dealing with Listeria. “You have to use science when you address these things. You can’t just go on gut feel or instinct.” A good scientific approach involves understanding your plant’s history with Listeria, and frequent random testing to ensure that every potential hazard receives prompt attention. “If your testing program is effective, you can identify indicators of Listeria well before they come in contact with the product.”

Putting on the Gloves: An Organized Approach
Over the years Cramer has built and honed an aggressive environmental monitoring program for Specialty Brands’ six plants, referred to as the Environmental Site Program (ESP). “I liked calling it ESP because we use the data to predict the acceptability of our sanitation program,” notes Cramer. Using a complex tracking system built with the support of the company’s information technology team, Specialty Brands created a comprehensive set of Excel spreadsheets that allows Cramer to randomly monitor and track every Listeria test result that occurs inside the company’s six plants. The spreadsheets identify trouble spots early on, track percentages of positive Fraser broths overall, and most importantly, create documentation verifying that potential hazards have been dealt with and corrected. “With a spreadsheet program like Excel, you can log data results, calculate the number and percentage of positive tests and document your actions taken, all in one document,” he states.

To organize his testing program, Cramer had the plant quality assurance (QA) managers break each plant down into three categories: non-contact sites, which include walls, floors, drains, pipes or any surface that doesn’t have contact with products but may harbor pathogens; indirect contact sites, such as table legs, control panels or broom handles that have close proximity to products or that might be used by someone who handles the products; and direct contact sites, such as conveyor belts, fill hoppers and scoops that come into direct contact with the product. Each category is broken into separate target areas, which are then numbered for testing. Those numbered areas are loaded into that plant’s spreadsheet and a random number-generating feature spits out which areas are to be tested each week. Cramer sends notices to the plants notifying them of their test sites, secure in the knowledge that every site has an equal opportunity to be tested. “It’s very helpful,” he says. “We don’t have to pull the numbers out of a hat to be sure that it is random.”

The test swabs from each plant site are sent to Food Safety Net Services in San Antonio, TX. “We do not conduct any pathogen testing in our plants, not even for environmental swabs because the process involves enrichment of the organism and we just won’t take any chances of the organisms getting into the manufacturing environment,” explains Cramer.

The swabs are enriched in Fraser broth for 24 to 48 hours and confirmed on Gram stain as needed. Reported results are recorded on the spreadsheet. Fraser negatives indicate the surface is clean and are noted as zeros in the spreadsheet. Fraser positives, which indicate that conditions are right for an organism to grow, are noted as “ones” in the spreadsheet. When a Fraser positive shows up, the swab area is identified, recleaned and examined for possible damage or harborage areas. If the positive is in an indirect or direct contact zone, after being cleaned and sanitized the area is retested three times a day for three days—before the morning shifts begin, three to four hours into first shifts and three to four hours into the second. The Specialty Brands’ program requires that nine consecutive Fraser negatives occur to prove the problem area has been dealt with effectively.

All of the corrective actions, from the cleaning to the repeated swabs, are noted in the spreadsheet’s comment area. “That’s an important part of the process,” Cramer notes. “You can’t just have lots of data that points to a problem, you must have documentation showing how you addressed the problem and proof that your actions were effective.”

If the area has three additional Fraser positives within the nine consecutive tests the equipment is taken out of operation, broken down, cleaned and examined for possible sanitation issues or damage, such as scratched surface where biofilms can form or difficult-to-clean welds or hollow areas.

“It’s an aggressive approach,” Cramer admits of his program and the actions the company takes to respond to potential Listeria growth. “When you take equipment out of service, the line can’t run. But better the line doesn’t run than you send out suspect products.”

Once the equipment is returned to service swabs continue to verify that corrective actions were effective. If the program dictates that product sampling is required, the product from the line tested is placed on QA hold, from clean-up to clean-up on the line tested, until acceptable results are received. All of these additional actions are documented in the spreadsheet as well. The spreadsheets provide Cramer with enough data to see at a glance which sites might be trouble areas or require extra attention and what areas show a history of problems, enabling him to target potential hazards long before they get out of control.

Cramer also relies on daily equipment testing using ATP bioluminescence technology to identify presence of organic material and eliminate potential growth spots. Surfaces are swabbed daily, swabs are treated with a chemical that comes with the swab and put into a device that measures light to identify the presence of organic material or biofilm that might allow the growth of bacteria. Surfaces that produce positive bioluminescence results are recleaned and then resanitized. “You have to reclean it before it’s sanitized because you can’t sanitize a surface that has organic materials on it.”

If repeated positives appear, the equipment is examined for scratches or crevices that make it difficult to clean properly. The daily testing helps identify problem areas before bacteria growth can occur. “We take food safety very seriously and we are proud of that,” he says. “In some companies, food safety is just lip service but we walk the walk, beginning with our president and through our operations associates.”

Going for the Knockout
Cramer’s constant efforts to identify and battle pathogen growth give the company confidence that Listeria monocytogenes won’t be a problem for Specialty Brands. While his vigilance is what makes the system run smoothly, Cramer credits his championship team of food safety and quality assurance managers and plant personnel and his many industry partnerships with helping him put the most effective program together. Along with guidance and advice from trade association members, The HACCP Consulting Group helped him understand and interpret the regulations, Food Safety Net Services provided analytical services and the National Meat Association gave him guidance on regulatory issues. “We are a mid-sized company and we don’t have these kinds of in-house resources,” he says. “Our partnerships have brought us an awful lot of peace of mind.”

As for the ongoing match against Listeria monocytogenes, Cramer is looking for a decision—in the earliest round possible. “The industry can’t afford to go 15 rounds with this or any other foodborne pathogen that poses a high risk to consumers. We’ve got to continue to collaborate—among ourselves as food companies, with research organizations and trade associations, and with third party experts—to develop further the most effective ways we can find to eliminate the incidence of microbial contamination.”

Sarah Fister Gale is contributing editor withFood Safety Magazine. She has written for a variety of business publications, including Inc. Magazine.