Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Clean Matters

By Dan Okenu, Ph.D.
No Comments
Dan Okenu, Ph.D., Food Safety Manager, H-E-B

When my family and I eat out, food safety is always on our mind, especially for our three young children. So it is for millions of consumers across America who eat out every day, in view of the preponderance of food safety issues in the news and social media nowadays.

One very important question for retail food service businesses is how do consumers determine a safe quality food environment to spend their money and have fun with family and friends? A lot of these choices are made based on consumers’ perceptions of the food safety practices they see in the food service establishment. These customer observations may be made while in the comfort of their cars at drive-throughs, seated in the dining areas browsing over the menu or just standing over the service counter waiting for orders to be taken. Some customers would spy at the back of the house through those swing doors connecting the service area and the kitchen.

Food services with see through open kitchens are a delight to customers’ curiosity on how and where their food is prepared. Yet some pundits suggest that a visit to the restroom with a cursory look at its cleanliness is a close estimation of the establishment’s commitment to cleaning and sanitation, and perhaps, could be extrapolated to its food safety culture in general. Overall, the cleanliness of the food service environment, especially how we clean and what we clean with, as observed or perceived by guests play a pivotal role in determining their different levels of patronage namely first time visits, repeat visits and recommendations to family and friends. Apparently, these cleanliness predictors are associated with return-on-investment.

Figure 1: Dirty Cloth Towel in Dirty “Sanitizer” Solution
Figure 1: Dirty Cloth Towel in Dirty “Sanitizer” Solution

Many of you may have seen those food code compliant red buckets for sanitizer solutions only and the cloth towels for cleaning and sanitizing food contact and non-food contact surfaces in the restaurant. The major problem however is that more often than not, the sanitizer solution is just dirty water without active sanitizing chemicals, and thus cleaning/sanitizing with such a dirty “sanitizer” solution and a dirty cloth towel (see Fig. 1) is simply disgusting to customers. Such practice supports the spread of germs through cross-contamination from one contact surface to the other in the food service and food retail environments.

Other challenges that may be associated with this method of cleaning and sanitizing include the difficulty of preparing sanitizer solution that meets food code sanitizer concentration specification. For Chlorine-based sanitizers, it’s hard to maintain the required working concentration of 50 ppm to100 ppm in an open sanitizer bucket over a four hour period when it must be changed as stipulated by food code. This is because Chlorine dissipates over time in open containers. Moreover, organic debris in the dirty sanitizer solution can deplete free Chlorine in solution and thus lower the sanitizer strength. These factors would inadvertently lead to health inspection infringement and low inspection scores, if the sanitizer strength is tested by local health inspectors. In addition, low inspection scores may be obtained if team members forget to store the wet cloth towel in sanitizer solution when not in use, as required by the food code.

Thus, how we clean and what we clean with, not only matter to our guests but should also concern us as food business owners and food safety professionals. Indeed, such unreliable and unpleasant cleaning method may become the “smoking gun” during cases of customer claims based on foodborne illnesses purported to have been acquired after patronizing a restaurant, as may be authenticated by local health inspectors who tested the sanitizer strength during an inspection. In such instances, businesses will be compelled to settle customer claims without recourse to a more rigorous investigation to clearly identify frivolous claims and also explore the possibility that the foodborne illness may have been acquired from a different location.

Best practices: Where cleaning is a pleasure for your guests

Single use disposable no-rinse cleaning and sanitizing wipe (see Fig. 2) is clearly a better customer-friendly way to clean and sanitize in the food service environment. It is cost-effective, meets food code requirements, easy to dispense and use by team members and with robust aesthetic value that is most appealing to customers. Each wipe is engineered to effectively deliver quaternary ammonium chloride (quat sanitizer) at an efficacy range of 175 ppm to 200 ppm as required by food code. Wipes come with an easy-to-use quat test kit for demonstrating the sanitizer concentration to local health inspectors upon request, since quaternary ammonium chloride is a fairly stable compound that does not require several recurrent testing like Chlorine-based sanitizers. These wipes also contain an appropriate detergent that qualifies as a cleaning reagent and enables the cleaning of surfaces with one side of the wipe and sanitizing with the other side of the same wipe, thus maximizing usage to bring down cost.

Figure 2: No-rinse Cleaning & Sanitizing Wipes
Figure 2: No-rinse Cleaning & Sanitizing Wipes

The quat sanitizer in one of the most popular no-rinse sanitizing wipes brand kills up to 99.999 percent of common foodborne pathogens within 60 seconds of contact. These no-rinse sanitizing wipes are EPA approved for use on food contact surfaces and verified by NSF to meet public health and food safety standards. They are environmentally conscious as they conserve water, have less chemical residue and may be recycled as non-solid state materials.

Interestingly, wipes can be easily dispensed in three different innovative customer-friendly ways. A fancy handheld red bucket with wipe-dispensing compartment and used wipe trash compartment for the front of the house makes cleaning and sanitizing a great pleasure for both guests and team members. Wipes can also be dispensed in front of the house using a specially designed service apron with wipe holding compartment for easy dispensing in an impressive manner that is not disruptive to guests of all age groups in the dining area.

Additionally, there’s a convenient wall mount that can be mounted near the cooking equipment at the back of the house or behind the service counter for easy reach. No-rinse sanitizing wipes may be used throughout the restaurant in buffet & dining rooms, table tops, host/hostess station, counter tops, laminated menus, beverage dispensers, condiment section, take out counters and other similar hard non-porous surfaces in front of the house. These wipes may also be used at the back of the house on food prep tables, counter tops, non-wood cutting boards, ice machines, food carts, exterior surfaces of food mixers, kitchen appliances, steam tables and other similar hard non-porous surfaces.

From my experience, the only down side is that wet wipes are not so effective in cleaning hot cooking equipment with large oil spills. Several wipes will be needed to do a good job while using heat-resistant gloves for hand protection against heat transferred unto the wipes during such cleaning.

Finally, the overall cost of using no-rinse sanitizing wipes comes with a significant cost savings when compared with the unreliable and inelegant method of using dirty cloth towels in red buckets of dirty sanitizer solution. It is evidently a wise business decision to get rid of the red sanitizer buckets and cloth towels, since these no-rinse sanitizing wipes are not only appealing to guests but may improve the bottom line. The use of no-rinse sanitizing wipes is clearly a better customer experience! A chain wide roll-out experience supports the use of independent third party for formal product testing and evaluation, developing SOP, proper team member training and cost-benefit analysis in any particular business environment. This will ensure appropriate use, regulatory compliance and overall benefits accrual when a business embraces these best practices that will ultimately enhance food safety, protect customers and safeguard the business brand while supporting business growth.

Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific
In the Food Lab

Molecular Diagnostics – Generations One (Pre-1995) and Two (1995-2005)

By Ravi Ramadhar
No Comments
Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific

While the first application of molecular methods for food could be attributed to the invention of the genetically modified corn plant, wide adoption of these technologies was ushered in through use in detecting food borne pathogens.

Generation 1 (Pre 1995) – Straight from research to food labs… not so fast

In the early 1990s, the amplification of specific gene targets and DNA using polymerase enzymes and thermal cycling (polymerase chain reaction, typically abbreviated as PCR) was gaining widespread use in the scientific research market. However, applications in clinical diagnostics and food testing were only just launching. 

The first generation of molecular food safety assays were direct application of similar techniques used in the research environment. As was typical for the research laboratory, a user would run the assay by use of a PCR machine and then transfer an aliquot to visualize on an agar or polymer gel. The DNA separated through the gel matrix relative to its size and negative charge. Subsequent staining of the gel, similar to staining a slide for gram staining, would display by a pattern of specific bands. The researcher would then interpret the results by the presence or absence of the bands. 

This workflow required a manual method of purifying DNA and setting up the PCR reaction as well as a subjective reading of the gels. Although this basic technique continues to be used in smaller experiments in today’s research lab, it was labor intensive, prone to errors and too cumbersome to lead to wide spread adoption in a food pathogen laboratory. Furthermore, another drawback to this early generation system was its reliance on non-specific and toxic dyes and required transferring of microliters volumes of liquids.

The major success of these early systems, however, demonstrated a core value of molecular technology: speed and specificity of nucleic acid (DNA) based methods. While the adoption in food slowly moved forward, advancements in both the research market and computing power would introduce a significant iteration for molecular methods in food testing – the introduction of automated results generation. 

Generation 2 (1995- 2005): The emergence of standardized food molecular and method workflow

Beginning in the late 1990s, the promise of molecular methods in food was further realized with the introduction of systems that simplified the assay set up and automated the results calling. The removal of these two barriers led to the wider adoption of molecular methods in food testing. 

Leveraging the wider availability of the desktop PC and available computing power, developers improved on generation 1 systems by automating the results interpretation. By training underlying software through algorithms to determine the presence or absence of a specific signal, the software could yield a non- subjective present/not present answer. This was a vast improvement over other methods such as immune assays or lateral flows, which relied on a user to interpret the presence or absence of a band. This advance, coupled with development of solid form reagents and removal of the requirement for transfer of the PCR reaction, provided the next core value of molecular methods: ease of use. However, like the first generation of molecular methods, generation two also relied on another non-specific dye that inserted itself in the DNA. This dye, SybrGreen, was a more specific dye for DNA, but relied on a non-specific melt curve and needed up to 3 hours for a detection cycle. 

One success and significant outcome from generation two systems was establishing the standard steps for a molecular method workflow applied to food testing. 

Figure 1: Standard steps of a molecular food testing assay
Figure 1: Standard steps of a molecular food testing assay

This workflow incorporated four major steps: first, an enrichment step increased the number of target organisms to a level matched to the method’s sensitivity; next, an aliquot of the enrichment would be used to make the DNA accessible, either thru DNA extraction or dilution of a crude cell lysate; thirdly, the PCR amplification step, followed; finally by the detection and generation of automated result calling-presence or absence. 

One key outcome of using automated generation software was establishing the importance of including an in-sample positive reaction control. This positive control enabled labs to verify the correct performance of the PCR reaction and established the ability to rely on the results generated. 

While ease of use enabled the wider adoption of molecular methods for pathogens, the amplification and detection was still slow and prone to interference by food matrixes. The limited use of melt curves and a single dye limited the application to single targets and, by pushing the boundaries of the technology, an internal positive control. Attempts to increase melt curve analysis beyond single targets were fraught with false positive and negative results as the software algorithms could not effectively distinguish multiple signals. The state of food pathogen testing using molecular testing would be further changed with the advent of real-time quantitative PCR (qPCR), and the pace of innovation in food testing would begin its rapid accent.

Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)
In the Food Lab

5 Food Safety Testing Trends for 2014

By Thomas R. Weschler
No Comments
Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

With public concern about food safety growing, and the increasing globalization of the food supply chain, it is a critical and challenging time in the food microbiology diagnostics business. There are a number of dynamics at play that present both opportunities and minefields for players in this field. As in any market, those well informed and positioned will benefit. 

Data from two new reports from Strategic Consulting, Inc. (SCI) – Food Micro, Eighth Edition: Microbiology Testing in the Global Food Industry and Food Contract Lab Report (FCLR) – point to five major trends for 2014:

1. Increasing food microbiology testing worldwide: 

Food safety testing at food processing facilities around the world is increasing for a number of reasons. Public concern is a key driver, and every time the public reads about another food recall, the concern grows. Active media coverage of food safety issues is a prime catalyst. 

Also driving growth in food safety test volumes are increasing regulations in many countries and regions. The Food Safety Modernization Act (FSMA) in the U. S., and a heightened food safety action plan for China are just two examples, albeit critical ones given the volume of food production in the two countries. 

Not surprisingly, food processing companies are proactively increasing testing efforts in order to avoid the huge costs associated with food recalls, to their bottom lines, their brand names, and to avoid litigation. 

Growth in food micro testing will not be even across all geographic regions, however. Testing in North America and Asia will grow rapidly but Europe should see slower growth.

2. Growing use of rapid microbial methods: 

Thirty years ago, all microbiology testing utilized traditional methods for analysis. Beginning in 1980, newer microbiology methods have been introduced that are easier to use and faster, and as a result, more cost effective overall. 

Many food plants have embraced rapid microbial methods (RMMs) as the best way to meet their increased testing needs, but not uniformly across all geographies. While the use of RMMs is increasing everywhere, it’s quite striking how different the regions are in the level of their adoption of RMMs.

3. Booming business for food contract testing labs:  

As food micro testing increases, there are a number of factors driving the analysis of those tests out of food plants and into contract testing laboratories. 

In today’s world, running a food plant lab requires significant expertise, documentation, and investment. More and more food plants are finding the effort and investment prohibitive and outside the food plant’s core competencies. With many contract labs located near to food factories, they have been able to provide excellent service and value to food companies. 

Contract labs have also been willing to take on the increasing expectation that food testing laboratories be accredited. This alone has been a tipping point for many food companies in letting go of their food plant labs. 

Again, regions vary in use of contract test labs, with North American companies rapidly adopting the practice, while European and Asian companies showing more mixed uptake.

4. Increasing environmental testing, especially for pathogens 

Environmental testing is done by many food plants to validate their factory is under control. In the US, the evolving FSMA regulation will impact environmental testing. In fact, FSMA will require the 80 percent of US food plants governed by the FDA to have FSMA versions of HACCP plans, and to document that these food safety plans are actually working. 

As a result, FSMA will be driving an increase in environmental testing, especially pathogens, in plants governed by FDA. This is not to say that FDA plants weren’t doing environmental testing before, but that there will be an increased emphasis on more of this testing in the future.

5. Rising concern over Salmonella 

Salmonella is a major pathogen of concern. By SCI’s research, it is the most frequently tested pathogen, yet it still has not met the CDC’s target guidelines. While outbreaks of other major pathogens have been reduced, Salmonella has remained stubbornly at historic levels. 

In addition to recent high profile outbreaks and recalls, there is also the growing concern about antibiotic resistant Salmonella strains. At some point it is seems likely that Salmonella, or at least some serotypes of Salmonella, will be treated in the same manner as E. coli O157, that is, as an adulterant, and as such, not acceptable at any level in food. For all of these reasons and more, Salmonella will factor more heavily in food safety discussions going forward.  

SCI’s food microbiology research reports are based on extensive interviews with QA/QC managers in food processing facilities around the world, and one-on-one discussions with food safety experts from academia, government and industry, as well as diagnostic test manufacturers. For more information click here.

Rick Biros, President/Publisher, Innovative Publishing Co. LLC
Biros' Blog

Bill 2491 – NIMBY Pesticides and GMOs

By Rick Biros
No Comments
Rick Biros, President/Publisher, Innovative Publishing Co. LLC

Kauai is the 4th largest island of Hawaii.  It is lush and green with a 12-month growing season. Kauai is also where many of the outdoor scenes were filmed for Jurassic Park, the movie where a science experiment ran amok.

Syngenta is the inventor and primary patent holder of the pesticide Atrazine. Syngenta’s host country Switzerland as well as the rest of the European Union prohibits the use of Atrazine. The CDC website says one of the primary ways that Atrazine can affect your health is by altering the way that the reproductive system works. Studies of couples living on farms that use Atrazine for weed control found an increase in the risk of pre-term delivery. According to the CDC, Atrazine caused liver, kidney, and heart damage in animals; it is possible that Atrazine could cause these effects in humans, although this has not been examined.

In 2006 and 2008, dozens of children and teachers at Waimea Canyon Middle School on Kauai were sickened and sent to local hospitals. Syngenta denied that the adjacent fields of experimental GMO corn and the related pesticide spraying was the culprit. The Hawaii State Teachers Association filed a temporary restraining order against Syngenta to force them to stop spraying next to the school. Once Syngenta stopped spraying those fields and since then there have been no further incidents. Atrazine and other chemicals have been found in the drainage ditches leading from the fields into coastal waters and residents on the west side of Kauai reported massive sea urchin die offs in coastal areas. Obstetricians, pediatricians and other local physicians have expressed concerns about what they believe to be unusually high levels of normally rare birth defects and certain types of cancers. Parents report their children have higher than normal incidents of nose bleeds and respiratory problems. All this has been reported in his blog by Gary Hooser, a Kauai council member who co-introduced Bill 2491, late last year. 

According to Hooser, Bill 2491 contains three basic provisions:

  1. Pesticide and GMO disclosure;
  2. Buffer zones around schools, hospitals and homes; and 
  3. A county sponsored and paid for comprehensive study of health and environmental impact. 

The Kauai County Council passed into law Bill 2491 after they overrode a veto from Kauai’s mayor. Bill 2491 does not ban pesticides nor does it ban GMOs, it simply requires disclosure according to Hooser. The mayor of Kauai is not the only local to oppose Bill 2491. Opponents say the studies that the county will pay for (through higher taxes), are redundant to EPA, USDA and FDA activities regarding the use of both GMO plants and pesticides.

On January 10th, DuPont, Syngenta and Dow filed suit trying to overturn Bill 2491 as being invalid. In a joint statement that was published in the Wall Street Journal they said “It (the bill) arbitrarily targets our industry with burdensome and baseless restrictions on farming operations by attempting to regulate activities over which counties in Hawaii have no jurisdiction.”

I don’t think the bill “arbitrarily” targets the pesticide and GMO industry. I think it specifically targets the pesticide and GMO industry and that local governments should have the ability to regulate pesticides and agricultural activity. It’s their backyard, it’s their health, their commerce (or lack there of), it’s their lives and they are willing to finance it. Simply, it’s their decision!

Bill 2491 almost seems like a local zoning law, however, and a lot of anti-GMO consumer activist groups have jumped on the Bill 2491 bandwagon and it has become a battle ground for the GMO companies who will not yield any ground to additional regulations for fear that the local movement on GMO zoning will snowball on them. Perhaps this is why Bill 2491 is dubbed “The Pesticide Bill” by the local media, but The Huffington Post calls the same bill the “GMO Bill.” 

General Mills, Post and Kellogg’s have all announced non-GMO versions of their core brands of cereals. Why? Because there is a market for them! The organic market continues to gain market share, with food processors and retailers helping accelerate the growth. Kauai happens to have a fairly large organic farming community, which is at risk from cross contamination from experimental GMO plants that are being sprayed with pesticides to determine the amount of pesticides needed. This is a point that even Hooser failed to point out.

I am not opposed to all GMOs and feel they offer certain benefits (drought resistance for example) that should be utilized when appropriate. However, the use of GMOs for the sole purpose of selling more pesticides is not something I support. And if I felt threatened by them, I’d like to have the ability, with the consensus of my community, to prevent them from being used in or very near my backyard.

References: 
1. CDC’s website with Atrazine information, http://www.atsdr.cdc.gov/PHS/PHS.asp?id=336&tid=59

Ask The Expert

Air Monitoring Under FSMA

No Comments

The proposed FSMA rule on Preventive Controls for Human Food is making HACCP an integral part of all food manufacturing and mentions air as a potential source of contamination, but does not specify frequency. How can you take a risk-based approach in incorporating air monitoring into your HACCP plan? This week’s Ask the Expert focuses on Air Monitoring and Media Prep.

Q: An auditor recommended a specific air monitor. How do I decide if it’s really the right instrument for our facility? How do I start evaluating systems? How do I get up and running once I buy something?

A: To select the right air monitor you need to consider the needs of your facility, such as whether you need to test only ambient air or also compressed air. You also need to consider the different types of air sampling technologies, such as open versus closed systems, impaction versus centrifugal samplers and viable versus non-viable particle monitoring.

The first thing to consider is your facility. Does your facility use compressed air or compressed gas? Compressed air can be considered to be in direct or indirect product contact if it is used for mixing ingredients, cutting, sparging, drying, transporting ingredients through your processing systems, or in packaging. Thus, the microbiological content of the compressed air directly impacts product quality, and you will need to do compressed gas monitoring. Organisms in the environment can also impact your product, leading to the need for ambient air monitoring as well. Some air monitors are dedicated instruments that can only do either ambient or compressed gas testing. Others are designed primarily for ambient air monitoring but compressed gas adaptors are available as an accessory.

Another consideration is the mechanism by which air is collected and monitored. Many systems operate by impaction air sampling, in which air is drawn through a perforated lid to impact on the agar in a Petri dish. Another configuration is the centrifugal air sampler, in which the head of the air sampler spins and air impacts on a circular agar strip. To choose the right model for your facility, consider whether it is an open system (using a standard agar plate configuration) or a closed system with agar plates/strips that must be purchased from the instrument vendor. Here there is no right or wrong choice; it simply depends on a balance of the quality, ease of use, cost and variety of available media. You should also ask the vendor about the biological efficiency of their instrument. Biological efficiency considers the instrument’s ability to recover organisms. Another question to ask is the impact of using the instrument on the airflow in the facility – some are designed to be less disruptive than others.

In many facilities, viable air monitoring is enough. However, in facilities making product for sensitive populations – such as infant formulas or meal replacement beverages for the elderly or infirm – the manufacturing environment must be much cleaner, and air monitoring may also include non-viable particle monitoring. Here, you need to think about the sizes and number of particles you need to detect, whether you need a portable instrument, and any clean room regulations you may need to meet.

The final consideration in choosing equipment is ensuring the vendor will support you with adequate training and in the maintenance and repair of the instruments.

In addition to purchasing equipment, you need to decide where and how frequently to monitor. The proposed FSMA rule on Preventative Controls for Human Food seeks to make HACCP an integral part of all food manufacturing and mentions air as a potential source of contamination, but does not specify frequency. As a result, you must take a risk-based approach in incorporating air monitoring into your HACCP plan.

Q: We use a lot of culture media – both broth and agar. Our employees in our media kitchen hate breathing in all the dust and cleaning up the mess. We even have one staff member who has recently complained of health issues as a result of her time in the media kitchen. Is there anything we can do to make the job of media prep safer and easier?

A: Media prep is a messy job. Powdered media generates a lot of dust, which is messy and makes it hard to breathe. Making media can also lead to health issues – some media components may be toxic, while others can eventually lead to allergic reactions. There are products on the market that make media prep cleaner, safer and even a little faster.

The best alternative to the mess of powdered media is granulated media. The unique formulation of granulated media means much lower dust. That makes media prep less messy and cleanup is much easier. Lower dust also means less inhalation, making media prep less unpleasant and a lot safer by reducing the operator’s exposure to toxic or allergenic media components. Granulated media is also easier to handle – granulated media flows better, pours more easily, and falls right to the bottom of the flask instead of sticking to the sides of the vessel, and it goes into solution faster.

Safety of your employees is important, but you also want to make sure your media will provide you reliable recovery of organisms. This is not just a matter of the formulation of the media, but how reliably and reproducibly it is manufactured. Are the media components uniformly distributed in the bottle? And how does the manufacturer perform quality control testing? One sure way to know the media are of a high quality is if the vendor complies with ISO 11133. This ISO standard describes the quality assurance or culture media for microbiological analysis of food for humans and animals, as well as for water testing.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

What To Expect When Expecting

By Shawn K. Stevens
No Comments
Shawn K. Stevens, Food Industry Counsel

Childbirth and FDA inspections have a lot in common. Both are, in their most basic form, a natural part of life, both can be exceptionally strenuous while occurring and both, when finished, typically result in the highest form of extreme happiness and joy. But, more on that in a moment.

With the recent arrival of the Food Safety Modernization Act (FSMA), Congress has tasked FDA with the enormous responsibility of substantially improving the overall safety of our national food supply. To accomplish this goal, the new law imposes significant new legal (and, by extension) regulatory requirements on the food industry, and gives FDA a wide-range of incredible new powers and authority to enforce the new standards.  In turn, FDA will begin using those new powers in future food safety inspections to ensure that all food companies have implemented comprehensive, science-based written food safety plans, and have satisfied the long list of additional new mandates.

So, what can we expect when expecting?

Well, there is a great deal of apprehension in the industry. We all know that FDA is coming, but many companies are not quite sure what will happen when FDA finally arrives. Not a single company has yet to experience its first “FSMA inspection” and, as a result, the industry is, in part, begging for some help on how to better prepare for the arrival of this new, perhaps life-changing, event.  

We are here to help.

The first, and most important, step in getting ready for your first FSMA inspection is appropriately managing the broad range of emotions you will likely feel. Rather than being apprehensive, or resisting the inevitable, I recommend that my clients “embrace” the inescapable conclusion that FDA is coming to their facility. Like childbirth, the presence of FDA is now, or will soon become, and integral a part of their life. And, whether they like it or not, they have to prepare.

The second thing I tell my clients is that it’s okay to be at least a little apprehensive. It’s okay not to know what to expect. And, we’re here to help on that front too.

We understand, of course, that an FDA inspection can be a long and laborious process. For some, it will be downright excruciating. For others, it will instill a complete and total sense of helplessness.  

Although we all anticipate and hope that the process will end quickly and without complication, sometimes things can and will go wrong. There may be yelling, and we may even be asked, when things become really tense, to control our breathing. And, of course, sometimes, the process takes longer than we expected, and sometimes emergencies will happen. In these cases, stress builds, apprehension grows and panic, even if only briefly, may set in. Before it is over, you might even experience some chaos and, perhaps, a bit of confusion.

But, eventually, the tension subdues. And, like the incredible and indescribable joy and adulation that accompanies the arrival of a new life, so too is the overwhelming happiness that exists when the FDA compliance officers leave your facility — and are walking to their cars.

So, the first and most important lesson to master when you are truly “expecting” is to embrace the process, understand that it is a fact of life, know that it will eventually happen, and that it’s okay to be just a little bit scared. The second lesson you should embrace is to begin planning for the arrival of that inevitable day now. And, we stand ready to help there too.

In our next post, we will begin to explore why FDA is coming, and what FDA will “expect” when it arrives.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

When FDA Comes Knocking…

By Shawn K. Stevens
No Comments
Shawn K. Stevens, Food Industry Counsel

When you made the decision to work in the food industry, you also agreed to shoulder the incredible and important responsibility of feeding a nation. Put another way, you have given your own personal commitment, on a daily basis, to ensure that the food you are producing is as safe and wholesome as it can be.

In addition to this tremendous commitment and responsibility, you also agreed, whether you like it or not, to subject yourself to intense regulation and oversight by the U.S. Food and Drug Agency (“FDA”). Thus, if you have not yet had the opportunity to become intimately familiar with FDA, chances are that in the coming months and years, you will. Put simply, FDA is coming.

So, what does that mean?  That . . . “they’re coming…”

As you might recall, the phrase began its life as a line in a very scary 1982 movie called Poltergeist. And, in many respects, it encompasses what we are (or, will be) experiencing in the future as a regulated industry with the FDA in our mirror.

With food safety awareness increasing nationally among consumers and the media, and with the recent passage of the FDA’s Food Safety Modernization Act, FDA has been directed (and has consequently pledged) to begin inspecting food processors more often, more closely and more intimately. For this reason, whether you like it or not, you need to embrace the fact that in the coming months and years you will be closely … well, “haunted” by FDA.

Now that we have established that FDA is coming, what can (or should) we do about it? Well, just like in Poltergeist, locking the doors won’t help. Neither will closing the widows, dropping the shades, or completely ignoring the problem. And, no matter what, don’t go into the basement.

But, there are a number of things that can (and should) be done. Understanding that your next FDA inspection is unavoidable, and it will happen, it is absolutely critical to begin a dialogue today on what to expect, and how you should react, when it does.

Thus, in the following series of coming posts, we will walk you through the FDA inspection process, help you understand what to expect when it occurs, and give you advice on how to best respond.  We will examine closely the reasons why FDA may visit your facility, the purposes for which it is there, the things it will expect to see, and what you should be doing now to get ready.

Although some may consider this a “ghost” of challenge, we hope that we can provide greater transparency to FDA inspection process. With a little help, and some basic planning, there is no doubt in my mind you will survive.

FST Soapbox

EQMS and HACCP – Friends or Foes?

By Kelly Kuchinski
No Comments

How quality processes can allow companies to take a more preventative approach to product recalls.

HAACP4 300x281 EQMS and HACCP Friends or Foes?I recently spoke to a friend who was a plant manager at a food manufacturing company, and he is all too familiar with today’s manufacturing challenges and product quality issues. We discussed how quality processes allow companies to take a more preventative approach to product recalls. He agreed that if quality and regulatory requirements are met before a product leaves the facility, organizations can be sure that they are providing safe product to their customers. The ability to identify issues before a product is distributed can also reduce additional costs associated with product recalls and the impact on a brand’s reputation and sales.

We then discussed how important HACCP was to his team. Hazard Analysis and Critical Control Points (HACCP) is a process control system that identifies where hazards might occur during the food production process and puts actions into place to prevent such hazards from occurring. By monitoring and controlling each step of the process, there is less chance for contamination or other hazards to occur.

He shared a story on his first experience implementing a HACCP plan at his previous facility. He noticed key areas where sanitation standards were not being met so he identified necessary corrective actions required to keep finished product safe. The process of monitoring these changes was difficult to manage and was draining the already limited resources in the plant.

During a team meeting, he brought up the issue and the QA Director mentioned that they were using a quality management system that managed workflow processes. They discussed how CAPA and complaint management were key processes that they were using in the QA area and it would easily support corrective actions associated with HACCP.

Within a few days, they were able to setup the system to support his team and automate the process. The most notable difference in using the QMS software was the time savings and reduction in recording errors. The system provided an interface that was easy to use and provided drop down menus for easier navigation through the system, unlike the cryptograms needed to use their ERP system.

As we finished up our call, we agreed that the true benefit of a quality system is visibility. We can now monitor potential hazards in the facility, manage outside supplier and third party manufacturers, and track compliance with regulatory requirements across the enterprise using one centralized system.  It is this visibility across the organization and its supplier network that allows organizations to tie in multiple quality controls, regulatory requirements and HACCP processes to automate and maintain the record of any change and preventative action to ensure consistency and safety of all finished products.

With companies encountering spikes in unforecasted demand, new levels of regulatory scrutiny, and fewer resources than ever before, my friend and I agreed that EQMS systems are more crucial than ever to help manage the complexities of quality process and allow issues to be resolved when they are identified early on.

About the Blogger:

Kelly Kuchinski, Industry Solutions Director at Sparta Systems, has 20 years of product management and marketing experience with a focus on consumer packaged goods, chemicals, life sciences and technology. Prior to joining Sparta Systems, Kelly focused on developing products and solutions to support companies across multiple industries to enhance functionality, increase efficiencies and reduce costs. She held product management and marketing positions at Merck Chemical, GS1, Checkpoint Systems and GE Capital. Kelly has an MBA from LaSalle University and received her Six Sigma Green Belt certification while at GE Capital.

Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
In the Food Lab

APEC Food Safety Cooperation Forum

By Janie Dubois, Ph.D.
No Comments
Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)

Efforts are ongoing in many regions to improve food safety; while the objective is obviously linked to public health outcomes, it is the business of food trade that really drives the funding for these activities. The reasoning is pretty simple: If efforts are made to meet the food safety requirements established based on risk (usually by developed nations) in order to enter or stay in trade markets, then the domestic population also benefits from safer foods. It is a win-win situation.

The Asia Pacific Economic Cooperation (APEC) Food Safety Cooperation Forum (FSCF) drives one such effort. The FSCF was established in 2007 to encourage the use of international food safety standards and recognized best practices to improve public health and facilitate trade among APEC member economies. The Forum also promotes information sharing and capacity building activities to accelerate the adoption of these standards and practices. The Forum is currently co-chaired by Australia and China. 

Why should we be involved in these initiatives? It is clear that it benefits the health of the U.S. population to improve the safety of food in the entire APEC region because we import it with minimal inspection (at least until FSMA rules come into effect). The U.S. imports just under $25 billion worth of fresh and processed fruits and vegetables, snack foods and red meats from the region. Once again, if we help the region adopt international standards, it also benefits their domestic population. Economically, we also benefit because the trade goes both ways and the region received over 70 percent of U.S. agricultural exports with soybeans, red meat, coarse grains and wheat adding up to ~$44.5 billion in 2012. The adoption of international standards reduces the likelihood that economies will impose their own standards, such as maximum limits (MLs) for example, that are not based on risk and may be hard to achieve using recognized good practices; these may be perceive as non-tariff trade barriers or reasons for devaluating crops from certain countries. 

One of the most difficult steps to perform in the establishment of standards for food safety is to assess the risk associated with particular foods for specific populations. Acute response and disease states are easier to spot and link to potential causes, but chronic conditions and responses triggered by combined risk factors are much more challenging, especially when they involve factors that are not food such as underlying diseases, genetic predisposition or environmental exposure. A very large project is active in the APEC FSCF to empower developing economies to perform risk analyses that will support their adoption of standards. Of course, it immediately comes to mind that risk assessment requires access to reliable data, an element that is non-trivial in a developing country environment. How does one measure exposure to a chemical or microbial risk when there are not enough trained analysts, not enough infrastructures or when the tests used are not fit for that purpose? THE APEC FSCF created the Partnership Training Institute Network in 2010 to stimulate a collaborative approach engaging industry, academia and governments to raise the capacity in the region. 

The impact of capacity building activities is often more far-reaching than meets the eye. A better understanding of the health and economic reasons behind international standards favors their adoption in countries that are modifying existing or adopting new standards. In turns, harmonization facilitates trade, trade improves the local economy and economic stability favors better health outcomes for the population. Beyond the big picture, there are very tangible benefits. In my line of work for example, we train laboratory analysts to perform tests in order to enable them to monitor their domestic food supply, which in time enables them to perform risk assessments that enable them to participate in international standards setting discussions, but it also benefits exporters to these markets by reducing the likelihood of unreliable results that could initiate shipment refusals or economic depreciation of shipments. International capacity building in food safety is a win-win situation.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

To Test Or Not To Test?

By Shawn K. Stevens
No Comments
Shawn K. Stevens, Food Industry Counsel

In recent years, the federal government has become increasingly aggressive in its investigation of foodborne illness outbreaks, its inspections of food processing facilities, and its food safety enforcement activities. Notably, the federal government’s recent full-court, food safety press has been driven, in large part, by the increased visibility and awareness of food safety in the media and among consumers.

As FDA has been given additional food safety authority in recent years, the USDA has stepped up its game as well. Not wanting to be left behind, perhaps, USDA has begun focusing more aggressively on possible connections between slaughter establishments and outbreaks or positive regulatory ground beef samples. Under the Systems Tracking E. coli O157:H7 – Positive Suppliers (STEPS) framework, for instance, USDA will often take action against slaughter establishments that repeatedly appear in the STEPS system. This can take many forms, ranging from intensified environmental pathogen sampling to a Food Safety Assessment (FSA) for cause.

If USDA decides to conduct environmental pathogen sampling to “test” a company’s preventative controls or its compliance with the regulations, that company is always welcome to take its own “companion” or “sister” samples. With that said, I do not believe there is any benefit to actually doing it.

If an USDA environmental sample tests positive, the agency will not care whether a companion sample tests negative. Contamination is not always distributed evenly, and testing sensitivities will often vary. Thus, FSIS will in all instances treat its own result as a “positive finding.”

The same general rules apply with respect to environmental sampling, whether being conducted by USDA or FDA, for other pathogens like Salmonella or Listeria. In the event of a positive, the government will likely not care about a negative companion sample collected by the company, and will rely on its own results. Moreover, what happens if the agency sample tests negative, and the companion sample collected by the company tests positive? I have seen it happen many times.

Thus, here too, I do not see any compelling benefit, nor do I counsel my clients, to always collect companion samples. Moreover, if they elect not to do so, it also avoids the complexities of determining whether to hold, test or even destroy companion samples in the event a governmental sample ultimately tests negative.

With that said, if a company thinks that it may someday want to take companion samples when USDA or FDA performs its own environmental testing, I would strongly urge that the company adopt a written policy governing the specific circumstances under which such samples will be taken. This, of course, would apply to both FSIS environmental and finished product sampling.

Such a policy should clearly define the limited circumstances under which companion samples will be collected, and state that those samples will ONLY be tested in the event of a FDA or USDA positive. In this regard, the policy should articulate that the company will rely upon the governmental findings (and it really has no choice), while at the same time setting forth the justification for performing companion testing (i.e., in the event of a finished product regulatory positive to assist in the determination of the ultimate source). The policy should also make clear, however, that if the FDA or USDA sample tests negative, the companion sample will be discarded within a set period of time (i.e., 24 hours).

If a company adopts such a policy, and then closely follows that policy, it should be able to avoid any second-guessing from the agency (or a trial lawyer in a future lawsuit) if a subsequent issue arises or a recall later occurs. Moreover, assuming the policy provides the underlying justification for the protocol to be followed (which it should), I also think any moral obligation to test a companion sample in the event of an agency negative simply falls away.

Increasingly, companies will find themselves in circumstances where the federal government is demanding to take environmental or finished product samples. Think twice, in those circumstances, about whether a “companion” sample is really your friend.