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. 
Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

The Food Safety Modernization Act for Dummies (Part 2)

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

In my previous column, I introduced the novel concept that achieving compliance under FSMA can in many ways be really quite simple.

Indeed, in its most basic form, FSMA mandates only a handful of requirements. If you are a food company, and if you source your ingredients domestically, you will only be required to show that you have:

  1. A written food safety plan;
  2. Records to prove that you are following your written food safety plan; and
  3. A traceability system in place (or, stated differently, that you have records to demonstrate where your ingredients came from, the products in which your ingredients were used, and the customers to whom your resulting finished products were sold).

In turn, the key to actually demonstrating compliance to FDA (when FDA visits your facility to perform its first FSMA inspection), is to craft your FSMA materials so that they are aligned as closely as possible with what the FDA will “expect” to see.

The cornerstone of FSMA is the development of a written food safety plan. To create your written plan, you will need to conduct a food safety assessment within your facility, identify those food safety hazards that are reasonably likely to occur within your products, and then develop and implement controls (i.e., critical control points) designed to manage those hazards.

It is important to note that the controls you identify will need to be proven effective (i.e., validation), and you will need to create and maintain monitoring records that will prove that your controls are working as intended (i.e., verification). You will also need to develop prerequisite programs designed to ensure that you are following good manufacturing practices, that your employees are following hygienic practices, and that your facility remains clean. Although you can actually write the first draft of your plan, it will ultimately need to be approved by a “qualified individual.” We, of course, can help you there.

To establish compliance under FSMA, companies will also need to adopt a robust traceability system. From a food safety standpoint, it will be very important in the eyes of FDA that all companies be able to identify the source of their incoming ingredients, the specific products in which those ingredients were used, and the companies to whom the resulting finished products were sent. This way, if there is a downstream problem associated with a product, FDA can immediately trace the product back upstream, and then quickly identify, contain and solve any potential problems.

So long as your program enables you to accurately and quickly accomplish these goals, FDA will likely characterize your program as compliant.

Next, if you do decide to source any food ingredients from foreign suppliers, you will also need to ensure that those suppliers are complying with each of the FSMA requirements as well. You can demonstrate compliance under FSMA by having a copy of your supplier’s written food safety plan (developed by a qualified individual) in your file. I would also recommend having your foreign suppliers audited annually, and performing some type of microbiological testing to verify the effectiveness of their programs and the quality of the products they are shipping. Also remember, both your plan and your supplier’s plan will need to be reassessed any time there is a change in any manufacturing process, or at least once annually, whichever comes first.

Finally, although this column represents the essence of FSMA, I would not be doing my job as a lawyer if I did not at least offer the following disclaimer: There are at least a few finer rules contained within FSMA not specifically addressed in this column and, regardless of where they are hidden, all of the rules are and will be changing routinely. Thus, as you work to develop your plan, it will be critical to read the Act and ensure you understand each of the Federal requirements and FDA’s corresponding expectations.

But, we, of course, can help with that too. So, as you march forward toward compliance, rest assured, it really can be quite simple. Yes, you CAN develop a written food safety plan and chew gum at the same time … just don’t do it on the production floor.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

The Food Safety Modernization Act for Dummies (Part 1)

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

There has been a lot written in recent months about the perceived complexities of the Food Safety Modernization Act (FSMA). The new requirements are broad and onerous, stakeholders complain. The proposed rules will be burdensome and costly, experts predict. And FDA enforcement will be varied and inconsistent, others warn. And, yes, even I have been at least partially guilty (I will reluctantly admit) of adding my own voice to the growing chorus detailing all the unfavorable features of FSMA.

But, as I continued to think about the problem, I quickly began to realize that none of this commentary is overly helpful for the business owner simply trying to achieve compliance. Most companies don’t really care about listening to experts pontificate endlessly (which has been going on months and, in some instances, years). Instead, most companies just want to be told what they need to do. So, with that in mind, I thought it would be helpful if we started with a blank canvas, and approached FSMA from a different angle. FSMA for Dummies – or, compliance made simple.

To start out, let’s be clear, the general principles underlying FSMA are really quite easy to grasp. In its most basic form, FSMA requires companies to make safe food. Duh.

Second, food companies shouldn’t be misled about the difficulty of compliance. How a company goes about making safe food is, well, with just a few exceptions, left up to the company itself.

So far, so good? I hope so. It’s not very difficult.

Next, to actually demonstrate to FDA that a company has achieved compliance, a food company needs only to understand what the FDA inspectors will want to see when they show up at the company’s door. Here too, the answer is very simple. Generally speaking, if you process food products using ingredients sourced from suppliers in the U.S., there will be three basic requirements.

First, you will need to show FDA inspectors that you have a written food safety plan. Second, you will need to show the inspectors the records that you have created which prove you have been following your written food safety plan. And third, you will simply need to show the inspectors where your ingredients came from, the products in which those ingredients were used, and your customer to whom you shipped them. If you process foods using ingredients sourced from overseas, you will also need to have a folder in your file cabinet (or on your computer) called “foreign supplier verification program.” We will talk about what exactly FDA will want to see in that folder in our next column.

So, when it comes to FSMA, try to discount any forecasts of rough seas or dark clouds. Instead, embrace the idea that complying with FSMA can be very straightforward and easy.

And, with that footing, I will detail, in my next column, the basic steps companies can take to meet the three (or, maybe four) basic requirements listed above.

Yes, it is possible, even dummies can do FSMA.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Lawyers Are Like Pathogens

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

I’m often asked if I have heard the latest lawyer jokes. “No,” is my usual response. When it comes to attorneys, therearen’tmany jokes – mostly only true stories.

Unfortunately, the same holds true for food safety and the law. Few of the stories we read about today, whether they involve controlling new and emerging pathogens, complying with new food safety regulations, surviving the uptick in federal inspections and enforcement actions, or defeating an increasing number high-profile foodborne illness lawsuits, can be characterized as laughing matters.

The fact is, each of us has chosen to associate ourselves with an industry whose products quite literally affect the health and security of a nation. And with this choice, we subject ourselves to enormous responsibility, wide-ranging criticism, comprehensive regulation and continuous oversight.

Just hearken back to 1906, for instance, when Upton Sinclair published his controversial novel which was highly critical of the food industry. The federal government quickly responded with new legislation which, for the first time, would mandate continuous federal inspection in meat slaughter plants. On June 23, 1906, as the bill was debated, Senator Joseph Bailey (of Texas) was quoted as saying:

“Whatever may be said about the origin of this controversy and wherever the blame should be placed, there can absolutely be no doubt that nothing but a drastic [new] law can now rescue the beef industry . . . and give the public confidence in what they eat.”

Sound familiar? Well, shortly thereafter, Congress passed both the Wholesome Meat Act and the Pure Food and Drugs Act. These Acts (along with their successors) formed the basis of a national food safety policy which has fed our nation for more than a century.

And, one need only read the latest news stories and blogs to understand that the rules, regulations and policies that have been issued since continue to feed – in many ways – our regulatory and trial lawyers today. Thus, both lawyers and pathogens continue to persist.

So, what does this mean for the food industry? Well, despite creating one of the safest food supplies in the world, we will continue to be confronted with new and emerging challenges relating to food safety and naturally occurring pathogens. New challenges will trigger enhanced scrutiny, more regulation and additional laws. And, where there are laws, there will always be lawyers.

Recognizing there is no easy way to eliminate pathogens and attorneys (and the unique challenges they create), we will instead embrace our synergies, and work together to help you provide food that not only passes the scrutiny of the most astute consumer, but also the most obnoxious lawyer.

Next column: the Food Safety Modernization Act for Dummies – Compliance made simple.

Stay tuned!

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

The Food We Eat

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

The politics of food safety often leads to new rules and regulations driven mostly by passion and emotion rather than science and reason.

Our collective survival depends, quite literally, on the food we eat. Indeed, the safety of our food directly impacts our individual health, the well-being of our families, and (if we work in the food industry) the success and longevity of our careers. For this reason, each one of us, no matter what our own individual role, has an interest in making sure that the food we produce is as safe as it can be.

To date, the food industry has done an excellent job. Each year the U.S. food industry proudly distributes approximately 328.5 billion safe meals – and countless more safe snacks – to American consumers. Despite industry’s best efforts, however, the existence of naturally occurring pathogens in many foods remains a real part of our business and lives. Given limitations of science and, in no small part, consumer behavior, no one is immune. Every month, an estimated 4,000,000 Americans develop some type of food-borne illness; another 10,000 individuals will be hospitalized, and nearly 250 will die.

And, no matter how much we care about food safety, we must also recognize that foodborne illnesses will continue to thwart scientists and industry for a very long time. Additionally, given recent and substantial improvements in national foodborne illness outbreak surveillance, more foodborne illnesses are being identified, and more outbreaks are being reported. By extension, more outbreaks are being associated with an increasing number of foods, and more companies are – either directly or indirectly – being affected. Thus, if your company has not yet been associated with an emerging outbreak, faced a catastrophic foodborne illness claim, or announced a voluntary recall, chances are in the future it will.

Such increases in reported outbreaks and recalls, coupled with negative and frenzied media coverage, have also affected public and governmental perceptions of food safety. We now find ourselves operating in a world where the politics of food safety often lead to new rules and regulations driven mostly by passion and emotion rather than science and reason. And, as an increasing number of companies prove they are unable to accomplish the impossible (by guaranteeing, for instance, the removal of all pathogens from all products), we will continue to see more adverse media coverage, more governmental regulation and, by extension, more frustration. Just imagine, for a moment, a dog chasing its own tail.

With that said, however, there are things we can do break this cycle. We can and should embrace a robust food safety culture, closely monitor each of our suppliers, continuously refine our own GMPs, SSOPs and written food safety (or, HACCP) plans, and aggressively test incoming and outgoing product.

And, we need to stay apprised of new legislation and comment with a unified voice on the resulting regulations. Whether such initiatives involve adopting new requirements under the Food Safety Modernization Act, mandating new interventions, regulating additional in-plant validations, or requiring enhanced traceability from feedlot to fork, the ultimate success of industry (and, by extension, the consumer) will depend upon a commitment to stay both informed and actively engaged.

I look forward to working with FoodSafetyTech to provide timely insight on emerging trends in food safety, commenting on new laws and regulations, and offering expert counsel on what we can all do to anticipate new challenges, reduce risk and decrease regulatory exposure.

Ultimately, from an industry perspective, broader knowledge, thoughtful planning and aggressive engagement will be critical when it comes to ensuring – not only another safe meal – but our own collective survival.