Ask The Expert

Air Monitoring Under FSMA

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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
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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
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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
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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.
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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
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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.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Food Safety Labeling – Putting Rare Steak On The Chopping Block

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Like most people, I enjoy a good steak.  

I have also found that, in recent years, my options for good, quality steaks have increased significantly, as food processors and restaurant chains look for ways to distinguish themselves and their products. Industry has moved toward more value-added products, such as mechanically tenderized steaks, using needles to soften the meat and even to inject marinade. Indeed, I think it would be safe to say that the vast majority of steaks now consumed in restaurants are mechanically tenderized.

The use of such technologies, however, creates additional food safety challenges not present in non-tenderized products. This is because, to the extent there is any possible pathogenic contamination present on the exterior of a steak, the process of mechanical tenderization can push that contamination deep into the product, where it becomes more difficult to destroy through cooking.

With that backdrop, the U.S. Department of Agriculture is now becoming more involved in helping educate end-users on the risks associated with mechanically tenderized products. In particular, USDA has published new proposed rules requiring meat processors to properly label any mechanically tenderized meat products they sell. These new rules will likely have two effects: (1) they may make mechanically-tenderized rare or medium rare steaks nearly impossible to sell; and (2) they may drive the vast majority of these products out of the food service market.  

Here’s why. In addition to requiring processors to label these products as “mechanically tenderized,” USDA will also require processors to include validated cooking instructions which, if followed, will ensure that any harmful pathogens in these products are destroyed. The question, then, for industry will be whether cooking mechanically tenderized steaks to the higher temperatures needed to kill foodborne pathogens will prevent them in most cases from being served “rare” or even “medium rare.”  

To justify its new rules, USDA has cited a number of recent outbreaks caused by mechanically tenderized steaks. According to USDA, since the year 2000, there have been a total of six E. coli O157:H7 foodborne illness outbreaks attributable to mechanically tenderized steaks served in restaurants and consumer homes. These six outbreaks, spanning 13 years, have included a total of 176 confirmed E. coli O157:H7 cases that resulted in 32 hospitalizations and 4 cases of HUS (acute renal failure).  

While you can decide for yourself whether such a substantial change in the labeling of steak products is warranted by the fewer than 15 cases reported annually since 2000, what we do know is that the labeling rules are changing fast, and serving mechanically-tenderized medium rare steaks in restaurants may no longer be a legal option. Time (and temperature), of course, will tell. Ultimately, this is because whether the term “medium rare” survives will depend upon the validation studies governing any new labeling. USDA’s rules will require validated instructions to include, at a minimum: (1) the method of cooking; (2) a minimum internal temperature validated to ensure that potential pathogens are destroyed throughout the product; (3) whether the product needs to be held for a specified time at that temperature before consumption; and (4) an instruction that the internal temperature should be measured by the use of a thermometer. 

In turn, processors will need to demonstrate to USDA that the instructions are also “scientifically supported,” meaning they must demonstrate that: (a) the cooking instructions can repeatedly achieve the desired minimum internal temperature and, if applicable, rest time; and (b) the minimum internal time and, if applicable, rest time achieved by the instructions will ensure that the product is fully cooked to a level designed to destroy any potential pathogens throughout the product. On the other side of the coin, even if processors could properly validate their cooking instructions, it may be that we see some major restaurant chains shift away from using these products altogether.

Indeed, once the new labeling requirements go into effect, then restaurants will have a difficult decision to make: comply with the labeling instructions, or ignore them?Responsible restaurant chains will, of course, determine that they need to comply with the instructional labels. This is because the instructions, themselves, anticipate (or, at least warn) that the product at issue could possibly contain pathogens and thus must be cooked to a predetermined temperature in order to render that product safe for consumption. If those instructions are ignored, however, and a customer becomes sick (or, even dies, as a result), that company could be exposed to significant punitive damages for disregarding a known risk. Thus, the only responsible course will be to either:  (1) refine internal policy to ensure that all such products are cooked to the recommended temperatures; or (2) to purchase steaks that are not mechanically or needle tenderized. There really will be no other options.

So, the most likely longer term result, in my opinion, may be that the restaurant industry will begin to move away from needle or mechanically-tenderized products, unless and until those products can be subjected to processing interventions (like irradiation) that will allow the end users to prepare and then serve them somewhere south of well-done.  

So, if you like selling or serving (or, I suppose, eating) steaks that can be cooked medium rare, you may want to watch these new rules closely. In in the end, “medium rare” may become much more rare you think.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Brand Protection Requires More Than Wishful Thinking

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

We have learned in recent years that, if you work in the food industry, it’s not a matter of “if” your products will be associated with a recall, it’s really a matter of “when.”

Indeed, lurking somewhere in the darkest corner of a hot box, in the silent throes of a sales cooler, or in a case-ready package being staged for delivery, there are a few colonies of pathogenic bacteria waiting patiently for their chance to wreak havoc in our business and lives.

For more than a decade, our firm has worked closely helping the meat industry with crisis management, regulatory response and complex litigation following large-scale outbreaks and recalls. The unfortunate reality from a business perspective is that, in a disturbing number of instances, when outbreaks and recalls occur, the companies that are involved cease to exist.

Watching innumerable outbreaks unfold over the years, our firm has gained a deep understanding about the science of food safety, the epidemiology of foodborne illness outbreaks and the legal consequences of food product recalls.

We have also gained far-reaching experience analyzing why recalls occur in the first instance, and how they, in many instances, could have been avoided.

While all companies want their customers to believe that their products are as safe as possible, and try to communicate this fundamental message through their brand, in today’s world success requires more than just a good advertising campaign. In order so sell food safely, a company needs to demonstrate it can process a safe product. In order to process a safe product, the company needs to invest in making it a reality.

Food safety, unfortunately, doesn’t just “happen” by itself.

In addition to facilitating their own third party audits, and also ensuring they are maintaining regulatory compliance, companies should also be auditing their operations from a brand protection standpoint. When I conduct Brand Protection Audits on behalf of my clients, I can usually accomplish what I need in just a single day. I like to interview employees, learn about the company’s food safety culture, and review food safety training and operational materials. I will also assess a company’s written food safety plans, identify hidden gaps that create additional exposure, and suggest improvements that will avoid criticism by lawyers or media in the event of an outbreak or recall. Moreover, many companies are surprised to find out that their policies are not actually being executed as written.

In addition, companies can lessen their exposure (and, thus better protect their brand) in other ways as well. Working together, we can easily develop stronger and more effective supplier specifications and indemnity agreements that provide added protection, as well as ensuring that existing insurance coverage is sufficient to cover potential liabilities. We also work closely with companies to develop crisis plans and conduct mock recall training, in as close to a real-world scenario as possible, to improve their ability to trace, contain and effectively manage potential problems.

Finally, we help our clients respond to FDA Warning Letters (and 483s), as well as FSIS issued NRs (so as to avoid criticisms months or years later from a judge or jury), and also prepare for and respond to both routine and for cause Food Safety Assessments. Many companies simply do not realize that what they say today can (and always will) be used against them tomorrow.

With that said, merely creating the “image” that you care about food safety is no longer enough. History has taught us that by taking a few additional proactive steps right now, such as auditing the true depth and survivability of your brand (i.e., the Brand Protection Audit), companies can significantly and strengthen the trust in, and longevity of, their most important assets – their image and their brand.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech
Ask The Expert

Ensuring Microbial Safety of Compressed Air

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Karen P. Cronholm, Director, Regional Marketing, for EMD Millipore’s BioMonitoring Group, says that “Compressed air contains water vapor, particulate matter, oil vapor and droplets, and microorganisms,” and this is a critical area that wasn’t paid much attention to until recently.

The new FSMA standard has created a great opportunity for their products, Cronholm explains. Of the first two sets of rules proposed under the Food Safety Modernization Act announced in January 2013, the Preventive Controls rule focuses on production and distribution sources and covers environmental testing of compressed air.

The requirements for microbial air monitoring do not only apply to ambient air but also to compressed gasses used in the aseptic environment. While FDA has increased the scrutiny and placed more responsibility on the food and beverage companies, there is still much ambiguity on the safety rules as there are a number of compressed air testing standards and guidelines, such as ISO® 8573, 21 CFR part 120 & 123, and the Safe Quality Food Program (SQF; which is being increasingly used by F&B companies to ensure compliance and safety).

“There is increased interest in compressed air monitoring as required by FSMA, and there is also a lot of education needed around compressed air; how to specify air particle counts; what are the types of filtration; how to test, what to test, how frequently to test etc,” Cronholm adds.

The technology to test needs to work with non-selective media. If you consider the food processing environment, Listeria monocytogenes is everywhere Cronholm says; “not just in the final product, but throughout the process. We have to adopt a Zone approach to testing, and closely check the process controls and process monitoring of the environment.”

“We offer a wide breadth and depth of air monitoring products, at a high quality and value price. There are both open and closed systems allowing for both active and passive air monitoring,” says Cronholm, referring to the RCS High Flow Touch system that offers “easy-to-handle, high-precision sampling for the effective monitoring of microorganisms in air and compressed gases.”

The RCS High Flow Touch Microbial Air Sampler is capable of fulfilling these requirements and furthermore assures easy operation for safe results. Some of the features include: RCS centrifugal based sampling; flow rate of 100 L/min; being portable, battery-driven, low weight instrument; validated system; maximum sampling efficiency; optimal design with aerodynamics diminishing air turbulence; sterility assurance – easy to disinfect, autoclave-able sampling head; and easy to handle – convenient operation by an integrated touch screen.

“With this technology you can test samples and get results in a minute. They are very rugged devices, and faster than technologies currently available in the market,” Cronholm describes.

For more information visit: EMD Millipore – RCS High Flow Touch System

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

Capacity Building in Food Safety

By Janie Dubois, Ph.D.
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Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
I’ll start this with a blunt and age-revealing truth: This is my first blog. This means I am more than happy to receive your “constructive advice” and suggestions for topics. This blog will appear monthly and focus on capacity building in food safety.
 
I would like to start by explaining what I do and through the months, introduce a number of initiatives and organizations involved in this field. The thing about food safety is that we all want it and there is a willingness to improve it; however, this objective can always benefit from more engagement and better knowledge of the tools that exist.
 
So back to me… I manage the International Food Safety Training Laboratory (IFSTL), a public-private partnership between the University of Maryland and the Waters Corporation. The Lab is the latest program at Joint Institute for Food Safety and Applied Nutrition (JIFSAN), which itself is a public-academic partnership between the University and the U.S. FDA. Why so complicated, you might wonder, because it takes a village… Put simply, what we do is deliver courses on laboratory methods fit for the purpose of demonstrating the safety of food. Why the village? Because one important reason for testing is to meet regulatory requirements put in place to ensure the health of populations and enforced through trade channels. We are lucky enough to be able to involve the regulators in the US (i.e. FDA, USDA and EPA) to explain why the rules are there, why some methods fit the purpose and others don’t, but also we ask them to explain what the health and economic consequences of failures to deliver safe food are. Then we needed teachers for hands-on laboratory work, and we needed some resources to make it happen. As I said, it takes a village.
 
The IFSTL is a resource for technical assistance and training identified in the FDA’s International Food Safety Capacity-Building Plan published in February 2013. Goal 4 of the Plan specifically addresses technical assistance and objective 4.4 further defines the vision for multilateral acceptance of fit-for-purpose laboratory methods. Personal experience has taught us that some laboratory analysts embrace the flexibility brought about by requiring methods to be equivalent instead of a rigid imposition of pre-defined methods, but others would rather simply be told what to do. The flexibility allows each laboratory to apply the methods that best fit their situation in terms of access to trained staff, to instrumentation, to test kits and to financial resources, while still fitting the purpose of the measurement. There are usually quite a few recommended validated methods and good reasons to select any of them. So for that topic only, there are lots of questions requiring not only technical expertise on instrumentation, but also on the requirements of the regulatory system and, let’s face it, tricks of the trade.
 
The selection of courses we offer is guided by input from FDA foreign posts informing us of needs observed in their region. The need may arise from a new regulatory requirement, from a change in agricultural production and exports or simply because training is not available in the region. We also receive input from the industry, primarily but not exclusively from members of the JIFSAN Advisory Council. Finally, we also receive requests from other countries either through technical assistance activities or directly from analysists. Generally, we prepare courses that are open to the public (of laboratory analysts) from the US and foreign countries for registration, and these courses always benefit from a heavy involvement from the U.S. regulatory agencies. In some cases, we develop and deliver private courses for industry that include aspects of their own laboratory quality control systems. In a nutshell, that’s what we do at the IFSTL.
 
In the coming months, I will talk about a number of initiative in food safety capacity building and I hope that it will encourage us to continue to work together to achieve the goal of providing safe food to the world.