food & Beverage • concept to delivery • present to future • foodprocessing.com

Tips for food safety in 2013

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Table of contents 3 food safety regulatory

outlook for 2013

5 rotary impingement Tank cleaning equals significant Water and cost savings

7 How concerned Are consumers About food safety scares?

9 paramount farms Keeps nuts safe, partners Happy

11 clean curtains provide protection & flexibility

13 Background on Biofilms

15 fdA’s HArpc is Like HAccp

Ad indexgamajet ...................................... 4www.gamajet.com

Bunting magnetics .................... 8www.buntingmagnetics.com

goff’s curtain Walls ................10www.goffscurtainwalls.com

rochester midland ................... 12www.rochestermidland.com

food safety regulatory outlook for 2013Like last year, FDA will continue to evolve, enact and enforce FSMA.By Eric Lindstrom, Keller and Heckman LLP

2013 will be a memorable year for food safety. Like last year, 2013 will be dominated by FDA’s implementation of the Food Safety Modernization Act (FSMA). The law comprehensively

changes the reactive U.S. food safety framework to a prevention-based system. USDA will have its own food safety initiatives, howev-er without the burden of implementing a new statutory framework.

FSMA was signed into law on Jan. 4, 2011, and it granted FDA new authority, including a mandate to require science-based preven-tive controls throughout the food supply chain. It also gave the agen-cy enhanced authority regarding inspection, compliance, outbreak response and recalls.

FSMA required FDA to implement many of its provisions by July 2012, but the agency has been unable to meet its deadlines. Never-theless, we expect FDA to propose the delayed regulations in 2013 – if it hadn’t already done so in the final days of 2012.

Among the regulations expected from FDA, those implement-ing the hazard analysis, risk-based preventative controls in Section 103 of FSMA will have the greatest impact. Under Section 103, each registered facility, with some exceptions, will be required to evalu-ate, identify and develop a written analysis of known or reasonably foreseeable hazards that could affect food manufactured, processed, packed or held at the facility. This includes hazards introduced un-intentionally and intentionally, as well as those that occur naturally. The facility must apply preventive controls to minimize or prevent each identified hazard and to assure FDA that the food will not be adulterated or misbranded for failure to declare a major food allergen.

Although Section 103 technically became effective in July 2012, FDA will expect compliance with these new requirements in time-frames that will be described in the forthcoming final rules.

We also expect FDA to propose regulations in 2013 to protect against intentional adulteration of food for which there is a high risk of intentional contamination that could cause serious adverse health effects or death (FSMA Section 106); to implement sanitary food transportation practices to ensure that food is not transported under conditions that may render the food adulterated (Section 111); and to create a foreign supplier verification program requiring importers to perform risk-based assessments that verify that the food imported complies with the Food, Drug and Cosmetic Act (Section 301).

We anticipate FDA will increasingly use its new powers under FSMA. A recent example was provided by FDA’s late-2012 response to Sunland Inc. Upon inspection of Sunland’s peanut processing

facilities, FDA found significant violations of Good Manufacturing Practices, the presence of salmonella and company records indicat-ing that over the three years prior to the inspection, Sunland had introduced into interstate commerce peanut products contaminated with salmonella.

Prior to FSMA, FDA would have been required to seek an injunc-tion in federal court to halt Sunland’s operations. However, FDA used its new power under Section 102 of FSMA to suspend Sun-land’s food facility registration, halting the company’s operations very quickly. Over the course of 2013, we expect to see FDA more frequently asserting its new authority, including mandatory recalls.

Another area of increasing FDA focus is the safety of energy drinks containing caffeine and other ingredients with potential stim-ulant properties. In late November, FDA responded to a letter from Senators Dick Durbin and Richard Blumenthal, stating that it plans to seek specialized outside expertise, most likely from the Institute of Medicine, to assess safety issues including the vulnerability of certain populations, such as young people. This could result in guidance or new regulatory requirements.

USDA’s Food Safety Inspection Service (FSIS) does not have a new food safety statute to implement, but it generally shares the cur-rent food safety approach of FDA regarding the products it regulates; namely, meat, poultry, catfish and processed egg products. FSIS’s primary goal is to keep the commercial supply of those products safe by, among other things, preventing foodborne illness outbreaks. The emphases are on salmonella, listeria monocytogenes and E. coli O157:H7, plus preventing intentional contamination and, when an outbreak does occur, responding quickly and effectively.

As an example of FSIS’s plans for illness prevention, the agency is requiring establishments producing not-ready-to-eat ground or otherwise comminuted chicken and turkey products to reassess their Hazard Analysis and Critical Control Points (HACCP) plans to pre-vent the occurrence of circumstances that led to several recent sal-monella outbreaks. FSIS will begin verifying that in early 2013. The agency also will focus a significant majority of its investigations and enforcement actions on food safety-related violations.

On Nov. 30, two FDA final rules were published and became ef-fective immediately, permitting the irradiation of unrefrigerated raw meat, to control pathogens. Previously, only refrigerated or frozen meats could be irradiated. It is unclear to what extent companies will utilize these new food safety options.

Eric Lindstrom is counsel with law firm Keller and Heckman LLP, 415-948-2811 or lindstrom@khlaw.com.

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Tank cleaning has always been viewed as a necessary evil for manufacturers. During the cleaning process, a significant amount of resources (time, chemicals, water, electricity and

labor) is required between batches not only to appease FDA stan-dards but to ensure a reliable, uncontaminated, quality batch is pro-duced. Although these repeating expenditures have a significant ef-fect on the bottom line, there are food and beverage manufacturers that continue to rely on outdated yet standardized technology for cleaning, not realizing the potential opportunity for substantial cost reductions and revenue recovery through CIP optimization.

To understand how to optimize a cleaning process, one must first understand the basics of cleaning. Herbert Sinner, a former chemical engineer for Henkel, first summarized the basic principles of clean-ing in 1959. His summary, now referred to as the Sinner’s Circle, de-scribes the four factors that can be manipulated in any cleaning sce-nario: Temperature, Chemical Action, Time and Mechanical Force.

When the effectiveness of any factor is reduced, it must be com-pensated with the increase of one or multiple other factors. Washing dishes is an effective example of how the four factors interact. Hot water (temperature) is going to remove stuck on food better than cold. Adding soap (chemical action) makes the process even easier, and you can either soak a dish overnight (time) or scrub the dish clean (mechanical force). When cleaning tanks, it is impera-tive to examine not only the effectiveness of the clean-ing process but the efficiency as well, especially in such a competitive market.

Sinner’s Circle can be easily applied to tank cleaning as a way to compare the ef-ficiency of processes. The most common tank cleaning processes are: wetting (static spray balls), rotary wetting (rotary spray balls), boiling out, manual cleaning and rotary impingement cleaning. Ro-tary wetting and wetting are more easily understood as a “cascading method.” By applying massive amounts of cleaning so-lution to the tank interior, the residue even-tually erodes off. This results in a significant amount of time and effluent consumption and a minimal reliance on temperature and mechanical force (the average force from a spray ball, rotary or static, is approximately .01 lbs). The effectiveness of this cleaning process is accurately described as “fair,” often resulting in additional manual cleaning (scrubbing and scraping). The boiling out method offers a similar cleaning at an even slower rate, with even more efflu-ent and temperature, and no mechanical action. Manual cleaning,

on the other hand, offers a reasonable amount of mechanical force, with minimal effluent but often results in ineffective cleaning, due to human error. Also, with safety in mind, lower temperatures must be utilized therefore increasing time. Rotary impingement cleaning utilizes the most mechanical force than any other process, therefore reducing time and cleaning solution drastically. Additionally, a re-peatable and reliable result is assured.

How rotary impingement works Rotary impingement tank cleaning machines combine pressure and flow to create high impact cleaning jets. Cleaning occurs at the point at which the concentrated stream impacts the surface. It is this im-pact and the tangential force that radiates from that point which blasts contaminants from the surface, scouring the tank interior. In conjunction with this impact, these machines are engineered to ro-tate in a precise, repeatable and reliable, 360-degree pattern. This full-coverage, indexing pattern ensures the entire tank interior is cleaned, every time. This combination of impact in a controlled in-dexing manner results in an economic homerun, because impact is a one-time investment; chemicals, temperature and time are continual, never-ending expenditures.

Following are three specific incidences in which rotary impinge-ment tank cleaning was used to optimize an outdated clean-

ing solution. Example 1: Rotary Impingement vs.

Fill and Drain One of the largest hot dog manufacturers

was seeking a solution to the abundance of waste water the facility produced. A major-ity of the focus was spent trying to alter the manufacturing process, which result-ed in minimal savings. Eventually they upgraded their entire CIP process, and the final water savings were staggering.

The company utilized a fill and drain cleaning process to clean a series of four

ribbon blenders which were used to mix pro-cessed meat. Cleaning was required daily, be-

tween each batch. The effectiveness of the clean, when dealing with such meats remained the primary

concern. The residue, a buildup of oil and fats, and the se-ries of blind spots due to the tank design, caused even more

difficulties for the company to clean. Like most food and beverage companies, their cleaning process proved effective enough, thus the cleaning method remained the same for many years. The process in-cluded filling the tanks with water and agitating the blenders. This

rotary impingement Tank cleaning equals significant Water and cost savingsBy Gamajet

Mechanicalforce Time

Temperature Chemicalaction

Sinner’s Circle

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was then followed by manually cleaning the blades and under part of the agitator as well as any visually missed spots. Total cleaning time resulted in 4 hours per tank, 5,840 hours of downtime per year. The water consumption was approximately 18,000 gallons per tanks, 26,280,000 gallons per year (a cost of nearly $150,000).

After thorough evaluation, it was suggested the company upgrade their entire CIP process, starting with rotary impingement tank cleaning machines.

The new process included a Gamajet steam-operated pump power-ing five directional Gamajet V rotary impingement tank cleaning de-vices. The steam pump allowed for the necessary increase in pressure, as well as the hot water needed to clean oils. Steam was also preferred because the plant already had a steady source of steam and the steam pump is highly energy efficient. The pump allowed for the five Gamajet rotary impingement machines to operate at 15 gpm and 120 psi with 180-degree water. The cleaning process included a 5 minute pre-rinse to rid the tank of any bulk residue, a 10 minute wash and then a 5 minute final rinse. This process took 20 minutes for each tank, which was nearly 90% faster than the previous method, saving them 5,354 hours per year. The water usage was reduced by 92%, 1,500 gallons per tank verses the 18,000 gallons per tank previously. This resulted in the savings of 24 million gallons of water per year, and over $100,000 per year, on water alone. In addition, dangerous manual cleaning was eliminated.

Example 2: Rotary Impingement vs. Manual Cleaning Manual cleaning is a surprisingly common method. Facilities all

over the world are grabbing their hoses, pressure washers and scrub brushes, while locking and tagging out, for their CIP process. Al-though nearly every other process is automated, many companies still rely on manual cleaning as an effective way, not only to clean,

but to validate the cleaning process as well. Human error aside, no manual clean can ever be absolutely replicated. In

addition, margins for error are non-existent. A facility in San Francisco, CA was

utilizing manual cleaning to its fullest extent. The

company manufactures a wide range of sauces and was experiencing significant revenue loss to their tank cleaning procedure and they were under significant pressure to provide a more validatable clean and eliminate confined space entry. Their process included 4 kettles with dual agitators and the sauces were burnt onto the tanks. The cleaning process included 2 hours of manual cleaning every day. The manual cleaning included confined space entry, scraping and scrub-bing which had a significant effect on their tank downtime and water usage. The tank cleaning downtime was 2,920 hours per year and the water usage was 3,504,000 gallons per year which was costing them a total of $16, 293.00 per year.

The solution included two Gamajet PowerFLEX rotary impinge-ment tank cleaning devices, positioned precisely around the agitator to ensure thorough cleaning. The machines operate at 90 psi and 40 gpm per machine with 150-degree water, no chemicals. Cleaning includes a 5 minute pre rinse for the bulk residue, a 10 minute re-circulated wash and a final 5 minute rinse. Total cleaning time per tank is now 20 min-utes. The pre-rise of 5 minutes is the length of one-half cycle, and test-ing proved this to be sufficient for cleaning, however in cases where the residue has burnt on longer an entire cycle is requested for cleaning, fol-lowed by the final rinse. This ensures that every area of the tank is passed twice, and satisfies the plant sanitarian. As a result, the facility saves 2,434 hours total in tank downtime per year by cleaning 83% faster. They have also been able to lower the usage of water to 2,336,000 gallons per year, saving them $10,861.80 per year. Production was increased by nearly 10% and confined space entry was completely eliminated.

A quick history into spray balls and other “cascading” devices: Spray balls and rotary spray devices are, to this day, the most com-mon used tank cleaning devices. Static spray balls were introduced in the 1950’s with the development of CIP. They work in a way that the wash fluid is discharged from numerous holes.

This diffuses the energy of the fluid and, therefore, impact is min-imal, often as little as .01 lbs of force. The cleaning action thus results from a sheeting or cascading action with minimal impact from the turbulence as the cleaning solution (chemicals) cascades down the tank walls over long durations.

In one of the worlds largest ketchup manufacturing companies, the Gamajet was used in to clean ketchup from a blender.

The NPD Group (www.npd.com) provides consumer and retail information for a wide range of industries. The research firm has deep roots in food and

foodservice, helping clients to identify new business opportunities and guide product development, marketing, sales, merchandising and other functions.

How concerned are you about tHe safety of tHe u.s. food supply? (% of adults wHo are…)

2010average

2011average

Jan-august 2012 average

extremely concerned 10 9 9

Very concerned 16 16 16

somewhat concerned 29 28 29

slightly concerned 31 31 30

not at all concerned 14 15 15

Source: The NPD Group/Food Safety Monitor

How concerned Are consumers?Shoppers are only slightly concerned about the safety of the U.S. food supply despite frequent food safety outbreaks, reports NPD.

Even with frequent food safety outbreaks and recalls, concern levels about the safety of the U.S. food supply remain relatively constant – although there are temporary spikes when news of

an outbreak occurs, according to The NPD Group (www.npd.com), a Chicago-based market research firm.

NPD’s Food Safety Monitor, which continually tracks consumer awareness and concern about food safety issues, shows that for the period from January through August 2012, on average, 60 percent of U.S. con-sumers were somewhat or slightly concerned about the safety of the U.S. food supply, 25 percent were extremely or very concerned and 15 percent not concerned at all. The food safety concern levels in 2012 are on par with previous years.

On a biweekly basis, when the Food Safety Monitor survey is con-ducted, there are fluctuations in the percentages of consumers who are not or are concerned about the safety of the U.S. food supply based on whether or not there is a food safety issue in the news, but the annual averages remain relatively constant.

Every other week a representative sample of approximately 500 U.S. adults is asked a series of questions related to food safety, and NPD then issues the results in its monthly report.

The NPD Group Food Safety Monitor tracks consumer awareness and concern about food safety issues including salmonella, E. coli, mad cow disease, foot and mouth disease, acrylamide, trans fats, mercury in fish, avian bird flu and listeria. Consumers also are surveyed about their eating intentions of foods, including fast food burgers, chicken, ham, steak, fish/seafood, breakfast cereals, butter, milk, cookies and more.

Since November 2007, the Food Safety Monitor survey includes this question: “How concerned are you about the safety of the U.S. food sup-ply?” See the answers in the accompanying table.

There are spikes and then a leveling off with specific food safety outbreaks, according to NPD. For example, this past summer, in July and August, there were outbreaks and product recalls involving listeria contamination. In mid-July, a California-based onion plant recalled all

onions processed at its plant because of listeria contamination. Since a wide variety of products use the plant’s chopped, slivered and peeled onions, there were subsequent recalls of ready-to-eat and ready-to-cook foods issued by supermarkets and manufacturers.

In mid-August, pre-sliced apples distributed by a New Jersey plant to fast-food and grocery chains across the country were among packaged products being recalled due to possible contamination with listeria bacteria.

Listeria is a bacteria that causes food poisoning and is especially dan-gerous to the elderly, people with weakened immune systems and preg-nant women. Awareness of and concern about listeria peaked during the time the outbreaks were widely reported and then leveled off when the news subsided.

“The impact of a food recall on consumer attitudes and perceptions often depends on the amount of news coverage received, or the severity of the situation in terms of numbers sickened or dead as a result,” says Darren Seifer, NPD food and beverage industry analyst. “Recalls, unfor-tunately, have become more commonplace, but consumers are creatures of habit. It takes a lot for us to change what we eat.”

Click here for the full version of this white paper.

Paramount Farms Inc., the world’s largest pistachio proces-sor, likes to pride itself on being first and foremost a grower organization. Grower profitability is the No. 1 priority. To

maintain that focus, Paramount has built one of the most modern and efficient processing facilities in their industry.

Their plant and farm operation, based in Lost Hills, Calif., is de-signed to meet specific corporate goals. These include processing their partners’ pistachios at the optimal time while maximizing quality and grower profitability, efficient truck turn times (three-hour aver-age) and 24-hour pack-out information available after truck delivery.

This philosophy has worked, as more than half of California’s pis-tachio growers have chosen to partner with Paramount Farms. How-ever, Paramount, which also is one of the world’s largest suppliers of almonds, is always looking at how it can improve.

They grow, harvest, package, distribute, and export from multiple facilities. Paramount’s engineering and quality managers are always looking for ways to increase production to meet growing consumer demand, while exceeding the industry standard in food safety.

Since 2001, Paramount has partnered with Bunting Magnetics Co., based in Newton, Kansas, to provide the most current, accurate, consistent, and trouble-free metal detection technology and equip-ment available. This critical equipment provides final inspection be-fore product is packaged.

“The need to eliminate metal as well as foreign objects is criti-cal,” stated Bobby Castanon, Packaging Technician for Paramount Farms. “We needed to detect this as close to the entrance of the pack-age as possible.”

The metal detection equipment is used at two vital points in the processing flow: inspection after weighing on the scales and prior to packaging. They are used in conjunction with bagging machines as well as for boxes and large bags.

Paramount has put Metron CR 05 and LCR metal detection ma-chines, which are one-piece collar-style detectors, at the beginning of the processing flow on their gravity or vacuum/pressure conveying lines. Both these products allow Paramount to satisfy their inspec-tion levels to meet ISO 9001 and HACCP standards.

“In-line metal detectors were needed and it was important that we were able to detect as small as 1.5 FE, 2.0 Non-Fe and 2.5 S.S,” Castanon said. “It was also important that it is operator friendly and would work in our environment. We needed low maintenance ma-chines that would be easily repairable for quicker up-time.”

Overall, Paramount has incorporated over a dozen Bunting met-al detectors into its facility as part of the inspection protocol. The Quicktron 03 “R” is a “cowbell” gravity unit, which gives Paramount

extreme sensitivity with precise reject components to maintain mini-mal loss of good product. Any reject event is quickly examined by Paramount’s Quality Control team to find the contamination and determine its origin, if possible.

“I have been completely satisfied with the performance and reli-ability of the Bunting products,” Castanon said. “They are used to stop the machine as well as cowbell reject to keep our machines run-ning.”

Paramount, which retails its products under the Wonderful and Sunkist labels, processes its two products in a number of ways. Vari-ous flavors or forms can be added such as honey, sugar, salt, cinna-mon, roasted, raw or sliced. Within these different processing areas, moisture content can also vary. So, it is crucial that the metal detec-tors are all food grade and made of stainless steel construction as well as designed for harsh environments. The heavy duty diverter is wear resistant against abrasive products.

“Our epoxy filled search head and special construction of the control cabinet make it impossible for water to penetrate,” stated Rod Henricks, Bunting’s Product Manager for Metal Detection. “It prevents the threat of water penetrating the search head from high pressure wash-down effectively eliminating moisture or sweat accu-mulating while the unit is not in use. The solid head helps to stabilize and eliminate noise interference.”

The metal detectors need to be able to quickly adjust and com-pensate for any product effect. While each product is learned and stored in the controls by code, the operator for Paramount can easily select the current product and ensure compliance. Various colored test sticks are used hourly and randomly to check metal detector cali-bration.

Paramount has found other features which have been beneficial, such as the ease of cleaning of the reject mechanics and lack of main-tenance of electronics. Also, the automatic product learning, basic sensitivity adjustments and the built-in memory cards which are available on the main control board make it user-friendly for opera-tors to store and save data for safekeeping. Finally, Paramount has found the touch panel displays make navigation simple with only a four-level navigation which is password protected for security pur-poses.

“For us, we pay attention to detail. Our quality assurance pro-gram is committed to virtually eliminating foreign material,” Cas-tanon said. “We are the only nut supplier in the United States to receive ISO 9001 certification and have a deeply rooted commitment to total customer satisfaction. These metal detectors help us maintain that commitment.”

paramount farms Keeps nuts safe, partners HappyBy Bunting Magnetics Co.

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buntingmagnetics.com(800) 835-2526

©2013 Bunting® Magnetics Co.

Rejection is Good

Ensure product safety with integration into vacuum fillers

MeatLine 05Metal Detector

BUNTING

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clean curtains provide protection & flexibilityBy Goff’s Enterprises Inc.

A chronic sanitation problem for processors dur-ing washdown is preventing splashing to near-by active processing lines and operations. With

plant utilization being a strategy to maximize invest-ment in the facility, tightly located processes are very common. To avoid plant shutdown and contamination to other lines, Goff’s designed Clean Curtains to pro-vide processors with protection and flexibility.

Goff’s designed these Clean Curtains partitions to fit in with the sanitation needs of the processing envi-ronment. The curtains are constructed with a 40 mil USDA-grade PVC material that is non-porous and sheds water, solutions and soils easily. The seams are heat-sealed vertically to prevent the trapping of con-taminants. Curtain panels are clear from top to bottom for visibility to make a brighter working area. The Clean Curtain panels overlap to prevent wash breakthrough, yet allow traffic to pass easily from one area to the next.

Goff’s Clean Curtains slide back and forth on a 304 stainless steel track and trolley system. They have a 1.625-in. diameter roller tube and a 0.25-in. track flange for easy installation. They come with Delrin Ball rollers and integrated hooks. The track can be mounted suspended or angle-suspended and is available in stan-dard stainless steel or polished.

“One of the main advantages of our Clean Curtains is that plants can avoid shut down and reduce process line down time,” states Marcus Mohwinkel, Vice President of Sales & Marketing for Goff’s Enterprises. “The other main benefit is improving overall plant sanitation by prevent-ing cross contamination between lines during wash down cycles.”

Goff’s Clean Curtains are custom made to any layout and come complete with mounting hardware. The curtains are ideal for the meat, poultry, seafood, dairy, dry goods, prepared foods, beverage and pharmaceutical industries.

There are other curtain walls for uses away from food production. Curtain walls separate and maximize useable space while creating a retractable barrier for confining dust, dirt and contaminants as well as controlling heat and cold loss.

Some other products that can isolate one working area, especially during cleaning, from others include:

• Climate Curtains are a flexible way to control temperature. You can dramatically reduce temperature loss with double paneled vinyl curtain walls, lined with Thinsulate Ultra Insulation from 3M, that provide flexible, climate control isolation.

• Sound Curtains & Screens provide maximum performance with noise control. They’re designed to contain and absorb harmful industrial strength noises.

• Welding Curtains & Screens are available in custom sizes. They are made to stand up to the harshest shop environments.

• Strip Doors control traffic flow and contaminants. They let people and industrial equipment through, while blocking dirt, dust, noise and temperature-controlled air. They are for internal and external use and come in both custom and stock sizes.

• High Performance Vinyl and Mesh Doors are custom made for high speed use for internal and exterior openings. They’re made with wind load-rated solid vinyl and mesh.

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Worried About Biofilm?We have you covered.Intermittent hits in your environmental testing are a good indication of a biofilm problem. RMC can identify biofilm contamination with our patented detection kit and provide a unique biofilm remediation program to control biofilm formation in your food processing plant. Our remediation program and patented test kit offer:

Click here for a free test.

Brand protection

Reduced food safety risk

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Easy interpretation

Precise location of biofilm

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Biofilms are a significant survival mechanism that microbes use to survive in ecosystems. They are also critical to Earth’s ecosystems both on the macro and micro scales for organic

nutrients, mineral deposition and utilization in ecological cycles. A biofilm is similar to a “microbial forest” that enables a number of bacterial species to resist predation by other microbes like protozoa while enduring harsh environmental conditions and cycles.

Like forests, biofilms are dynamic with various phases: establish-ment, population and growth of this forest with impacts upon other microbes and biological entities. In biofilm study and research, the past 20 years have given us an appreciation for this dynamic, complex entity.

biofilm formation in food plantsBiofilm formation in food plants is a dynamic and vital function in order for either beneficial or harmful bacteria to survive. Consider a food plant to be a dynamic ecosystem on steroids. The whole adapta-tion of biofilm formation, destruction or damage and renewal is ac-celerated in a typical food plant due to the nature of food processing, food plant sanitation and environmental hygiene.

Biofilm-producing microbes have adapted to the plant environs based on a number of criteria. These criteria include ingredients and product matrix, plant design and its environmental deficiencies, pro-cessing line and equipment designs coupled with the adverse control measures these biofilm-producing microbes encounter. Some spoil-age/pathogenic microbes may not be the direct biofilm producers, but have developed a symbiotic relationship with the actual biofilm producing strains. In other plant dynamics, this occurs when spoil-age and pathogenic strains have adapted to rapidly create biofilms.

This accelerated process still includes the same dynamics found in nature. After “proper” sanitation all vestiges of biofilm have been removed from either a food contact or environmental surface. Native microflora in your plant’s ecosystem restores its survivability by seek-ing to form a biofilm. Food ingredients and usually water/moisture (except for properly maintained dry processing operations) are intro-duced immediately during production.

The diagram insert (above right) clearly shows the phases of bio-film formation. After a conditioning phase, specific genes in bacteria use their surface appendages (flagella, fimbriae, and pili) to secrete the biofilm foundation chemistry, the EPS (Extracellular Polysac-charides). The EPS or “slime” is what forms the “living cement” that helps to build the biofilm making it increasingly difficult to remove.

Within 8 to12 hours, if sanitation has not occurred, the third phase of biofilm growth and maturation begins. EPS is copiously produced now, protecting the very cells that are producing the bio-

film and also the visiting spoilage and pathogenic strains that con-tribute benefits to this microbial community. For up to 24 hours, these biofilms are considered to be young or immature.

However, as time progresses without a sanitation step, the bio-film undergoes continual growth, complexity, and the dynamics of sloughing occur. This is particularly found in food plants on envi-ronmental surfaces which will not be typically cleaned and sanitized in a 24 hour time frame. The sloughing of cells found in water lines, AC drip pans, drains, etc., can and will create the sporadic spikes in environmental swabbing, food contact swabbing or product samples. Sloughed cells are also the way the biofilm spreads and grows in a plant ecosystem. The small sloughed biofilm fragments can re-attach elsewhere, and start a new larger biofilm community on a non-food contact surface, an equipment component, or in poorly cleaned equipment.

Impact of biofilms on food safety programsOf course, in many instances the microbes within undetected or untreated biofilms on environmental or food contact surfaces that cross-contaminate products or ingredients are spoilage microbes that can adversely affect food quality. However, for one’s HACCP program, food safety can be adversely impacted when those biofilms contain pathogens, particularly those having Salmonella spp., Liste-ria monocytogenes, E. coli or the Bacillus species.

Due to the ubiquity and hardiness of Listeria monocytogenes (Lm), many studies have been undertaken on how Lm strains can form bio-films. In control measures below, we will cite some interesting studies on how these control modalities can be successively implemented.

Backgroundon BiofilmsBy Rochester Midland Co.

The surface composition is a key criterion as to how readily and tenaciously a biofilm can form either on a food contact or environmen-tal surface. Porous surfaces like cinder block, granite or marble read-ily form Listeria containing biofilms and are more difficult to remove. Stainless steel grades 304 and 316 are considered an optimal surface for biofilm removal. If there are improper sanitation procedures or hy-gienic design, Listerial based biofilms will readily form [1].

Conveyor belts are in direct or indirect food contact zones, but in most cases they are also critical for control of biofilm formation and their removal. A recent study by Texas Tech using Listerial biofilms showed that acetal or polypropylene mesh type belts had the best biofilm formation rates, less so with a non-weave type belt. Stainless steel in this study had the least but it depended upon the surface area of the belt with a weave having faster and more tenacious biofilm for-mation than a single loop stainless belt [2]. Consequently, any surface type or design that is conducive for biofilm formation is also more difficult to remove or control that biofilm from forming.

It also is critical that the hygienic design of the equipment unit in question lack the voids and crevices that make proper biofilm detec-tion difficult if not impossible. Some older or worn equipment must be either removed or refurbished to remove the growth niches due to poor hygienic design.

biofilm control measures for food safetyThe key control measure with respect to biofilms is the plant’s overall sanitation program both for environmental and food contact sur-faces. This must be not only comprehensive including both cross-contamination vectors derived not only from direct and indirect food contact zones (zones 1 & 2) but from adjacent environmental vectors like drains, flooring, walls, air handling units including drip pans, and overhead fixtures (zones 3 & 4).

Since a biofilm’s EPS utilizes a cocktail of physical and chemi-cal bonding interactions to adhere to and protect that adhesion to a surface, an appropriate level of energy is needed to remove that ado-lescent or mature biofilm. This requires thermal energy (rinse water temperature or surface temperature) and mechanical energy (rinse water pressure and mechanical agitation like scrubbing).

It also requires the appropriate chemical energy within the properly selected cleaner to assist in removing that biofilm. For example, since the immature or mature biofilm contains carbohydrates, and proteins, you usually need to utilize a chlorinated alkaline product delivered either as a foam or gel product for non-pipeline open surface sanitation. The same type of formulated product in a low foaming formulation is needed for a true closed pipeline type CIP system or for a COP tank. COP tanks are an excellent approach to remove biofilms from small parts like pipe or valve fitting, gaskets and O-rings.

Unfortunately, in some instances, either the SSOP overlooks the proper application of the appropriate mechanical energy to assist in strip-ping the biofilm from its surface, or the sanitation operator is pressed for time and relies on the chemical energy or an easy mechanical energy ven-ue like high pressure rinsing to remove the biofilm. While high pressure has a role to assist in biofilm removal on problematic equipment, it can also create dangerous pathogen containing aerosols that re-contaminate equipment while also damaging the equipment.

Other forms of mechanical energy or agitation need to be applied to reduce the need for high pressure removal of the biofilms like non-abrasive scrub pads, soft bristle nylon brushes (manual) or automated systems, like belt cleaning nylon rotary brushes or Brite Belt pads.

In some instances, you cannot properly or efficiently apply even a CIP cleaner to attain the minimal flow velocity of 5 ft/sec for water or food pipelines. In these cases, utilization of an approved disinfectant use level of an oxidizing biocide like Peracetic acid (liquid or foam versions) or Chlorine dioxide solutions can be excellent ways for purge disinfection flushes of pipeline systems [3]. These are followed by a wa-ter flush that can contain approved food contact sanitizer use concen-tration levels. The maturity and severity of the biofilm in these pipeline systems will dictate both the use-concentration range and the duration of the application.

There are other modalities being utilized both to remove and assist in controlling the rate of biofilm formation on food contact or even environmental surfaces. Use of ultrasonication during operation on a critical food contact surface and during the sanitation procedure have been known to remove more soil, biofilm, and microbes like Lm than sanitation without the ultrasonication [4]. Even for drain sanitation, the use of ultrasonication in concert with foaming Peracetic acid has shown marked improvement in removing Lm based biofilms in PVC drain pipes [5]. Furthermore, other studies by equipment manufactur-ers employing coating surfaces with silver halides or other surfaces with polyethylene films containing amines that get charged by chlorine san-tizers, have shown to reduce adhesion and slow biofilm formation [6].

Utilization of automated foamed QAC on flooring and drains for wet applications coupled with pellet or powder based QAC or Hydrogen Peroxide systems can markedly control biofilm formation, especially Lm containing biofilms on floors and drains in RTE food plants [7].

A coordinated program of proper equipment or plant hygienic design, coupled with the appropriate sanitation procedures using the appropriate chemistry, and physical/mechanical agitation approach-es, will control and slow down biofilm from forming on both food contact and environmental surfaces.

references1. Silva, et al., Journal Food Protection, Vol. 71 (7) Nov. 2008, pg 1379-1385, Adhesion to and Viability of Listeria monocytogenes on Food Contact

Surfaces.

2. Pitchiah, et al., Food Protection Trends, Vol. 28, Nov. 2008, Biofilm Formation of Listeria monocytogenes on various Conveyor belt surfaces.

3. Martin, et al., Journal Food Protection, Vol. 68 (3) March 2005, p 494-498, Elimination of Listeria monocytogenes Biofilms by Ozone, Chlorine

& Hydrogen Peroxide.

4. Lunden, et al., Journal Food Protection, Vol. 72 (2) February 2009, p 408-411, Pilot Scale Continuous Ultrasonic Cleaning Equipment Reduces

Listeria monocytogenes levels on Conveyor belts.

5. Berrang, et al, Journal Food Protection, Vol. 71 (1) January 2008, pg 66-69, Effect of Chemical Sanitizers with and without Ultrasonication on

Listeria monocytogenes as a Biofilm within Polyvinyl Chloride Drain Pipes.

6. Goddard, & Hotchkiss, Journal Food Protection, Vol. 71 (10), October 2008, pg 2042-2047, Rechargeable Antimicrobial Surface Modification

of Polyethylene.

7. Ceylon, Erdogan, Silliker Laboratories. 2011. RPN 15202, July 14, 2011, Validation of Quaternary Ammonia and Hydrogen Peroxide Powder for

Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry Plants.

Click here for the full version of this white paper.

15

fdA’s HArpc is Like HAccpThe agency’s newest FSMA ruling requires all food processors to create risk-based preventive control plans.By Eric Lindstrom, Keller and Heckman LLP

On Jan. 4 of this year, FDA issued a proposed rule imple-menting the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety

Modernization Act (FSMA). The proposed rule applies to certain unintentional hazards – e.g., microbiological, chemical, physical or radiological hazards – that may occur at a food facility that manufac-tures, processes, packs or holds human food.

HARPC is similar in concept to hazard analysis and critical con-trol points (HACCP), which is required for foods such as seafood, juices and USDA-regulated meat and poultry. Importantly, HARPC is not applicable to those HACCP facilities or to any USDA-regulat-ed facilities, among others.

For several decades, current Good Manufacturing Practices (CGMPs) have provided the main food safety framework for most foods regulated by FDA. The CGMP regulations cover general practices to be followed to ensure that food is manufactured, processed, packed and held under sanitary conditions, and that such food is safe, clean and wholesome.

Of course, HARPC has the same goals, but the approach is quite different from CGMP, as HARPC ushers in a new preventative frame-work designed to identify specific potential threats to the food supply and take appropriate steps to counter them before any harm occurs.

FSMA section 103, the statutory basis for HARPC, provides im-portant background regarding the purpose and general framework of preventive controls. Section 103 generally requires the owner, opera-tor, or agent in charge of a food facility to prepare a written plan to:

• Evaluate the hazards that could affect food manufactured, pro-cessed, packed, or held by the facility.

• Identify and implement preventive controls.• Monitor the performance of those controls.• Develop corrective actions if preventative controls are not effective.• Verify that preventative controls are effective.The proposed rule implements each of those aspects of the re-

quired written plan, which are discussed in greater detail below. The first step is to evaluate the hazards that could affect the food.

FDA proposes that a written hazard analysis identify “known or reasonably foreseeable” hazards for each type of food subject to the regulation. Accordingly, a facility may need to conduct multiple haz-ard analyses, even for similar foods.

FDA provides the example of tea beverages packaged in both glass and plastic bottles at the same facility as presenting different hazard

profiles due to the risks of the different packaging. In addition, the hazard analysis must also evaluate whether the identified hazards are “reasonably likely to occur” and, if the hazards were to occur, the severity of the potential illness or injury.

Once the known or reasonably foreseeable hazards are identified, FDA proposes that preventive controls are implemented for the hazards that are reasonably likely to occur. The preventative controls should provide assurances that the identified hazards will be “significantly minimized or prevented” and that the food will not be adulterated or misbranded under the Food, Drug and Cosmetic Act. The types of preventive controls will vary, depending on the facility and the food it produces. FDA believes that most hazards would be addressed through process, food allergen and sanitation controls. Some of those controls will require the establishment of critical limits, such as a heat process, which must have controlled parameters of temperature and time.

After the preventative controls are established, FDA proposes that they be monitored to show consistent performance and that records documenting the monitoring procedures be maintained. Examples of monitoring activities include visual observation and measurement of temperature, time, pH and moisture level. The frequency of moni-toring must be sufficient to ensure that the preventive control is con-sistently performed and effective.

FDA also proposes to require that facilities establish written cor-rective action procedures to be used if monitoring reveals that the preventive controls are not properly implemented or in the event of an unanticipated problem.

FDA additionally proposes that facilities take steps to verify the proper functioning of the overall written plan, including:

• Validation of the preventive controls.• Verification that monitoring is being conducted.• Verification that appropriate corrective actions are taken.• Verification that the preventive controls are consistently implement-

ed and are effectively and significantly minimizing or preventing the identified hazards that are reasonably likely to occur.

FDA proposes that the final rule would be effective 60 days after pub-lication in the Federal Register, with compliance required one year after the effective date – except that businesses meeting the definition of “small business” or “very small business” would be expected to comply two or three years, respectively, after the effective date. Comments on HARPC may be submitted to FDA until May 16.

Eric Lindstrom is counsel with law firm Keller and Heckman LLP, 415-948-2811 or lindstrom@khlaw.com.