Tag Archives: food safety tech

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ImEpik and Food Safety Tech Partner on Agreement for PCQI Online Training

By Food Safety Tech Staff
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EDGARTOWN, MA, Feb. 27, 2019 – Innovative Publishing Co., Inc., publisher of Food Safety Tech, has entered into a reseller agreement with ImEpik, an online training company that serves food manufacturers globally. Food Safety Tech will serve as a reseller of ImEpik’s PCQI online training course as per training that is required under FSMA.

“I’m pleased to announce our partnership with ImEpik, as it allows us to expand our efforts in giving the industry access to resources that are critical to food safety education and training,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo.

“Our ten-module online training program ensures that Preventive Control Qualified Individuals are proficient in the standards that are required under FSMA,” said Laura Lombard, CEO of ImEpik. “Providing compliance training in an online capacity also saves our ‘students’ time and money, as they can take the course any time and anywhere, without having to travel away from their job.”

As part of the partnership, the training will be offered at a reduced rate for professionals who also register to attend the Food Safety Consortium Conference & Expo, an annual industry event held October 1–3 in Schaumburg, IL.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

About IMEPIK

IMEPIK is a market-driven, and research-based online training company, facilitates food safety training for food manufacturers around the world. With an emphasis on accessible and innovative training, ImEpik offers a unique advantage in providing effective training for you, your employees, your association members, or your clients to ensure food safety compliance and best practices. We offer Preventive Controls courses that include the “standardized curriculum” recognized by the FDA.

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Food Safety Tech, Food Safety Consortium Conference & Expo Announce Partnership with Alliance for Advanced Sanitation

By Food Safety Tech Staff
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EDGARTOWN, MA, Jan. 18, 2019 – Innovative Publishing Co., the publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo, has announced a partnership with the Alliance for Advanced Sanitation. Angela Anandappa, Ph.D., director of the organization, will also be joining the Food Safety Tech and Food Safety Consortium Advisory Board. As part of this role, Anandappa will be a key resource on topics related to sanitation and will serve as chairperson for the Sanitation track at the Food Safety Consortium Conference & Expo, ensuring the presentations are relevant, accurate and balanced.

Angela Anandappa, Alliance for Advanced Sanitation
Angela Anandappa, director, Alliance for Advanced Sanitation

“The collaboration with Angela Anandappa and the Alliance for Advanced Sanitation is a significant enhancement to the Food Safety Consortium Conference & Expo,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo. “Angela brings a wealth of experience in food safety and molecular diagnostics, especially in her role developing programs that tackle hygienic design and sanitation issues.”

As a partner organization, members of the Alliance for Advanced Sanitation will also receive a discount to attend the Food Safety Consortium Conference & Expo in October.

“I look forward to working with Rick and his team at Food Safety Tech and the Consortium event to help industry further understand the issues we face in sanitation, the advances necessary for success and how we can share best practices,” said Anandappa, who is also a research assistant professor with the Department of Food Science and Technology at the University of Nebraska-Lincoln.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

About the Alliance for Advanced Sanitation

The Alliance for Advance Sanitation’s research, extension and teaching activities engage university of Nebraska–Lincoln faculty and address the needs and interests of the private sector partners. The overall goal of these activities is to develop improved sanitation practices that can be implemented by the food processing and affiliated industries. The Alliance’s mission is to create a safer food supply through advanced sanitation approaches and practices.

Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

Food Safety Consortium Sneak Peek – Food Defense Rule

By Sangita Viswanathan
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Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

The Food Safety Modernization Act is the first instance of codified food defense regulations. This discussion is a hard look at the proposed food defense requirements and examining what compliance may look like. 

At the upcoming Food Safety Consortium, to be held November 17-18 in Schaumburg, IL, Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association (GMA), will address the key takeaways associated with the proposed regulation.

Following this presentation, Sarah Sunday from Kraft will talk about challenges the industry will face in implementing the rule as written and how the industry currently addresses food safety.

In a chat with Food Safety Tech, Cooksey provides a sneak-peek into her presentation.

FST: How are Food Defense requirements evolving under proposed FSMA rules?

Cooksey: GMA led industry in developing comments on the proposed Food Defense rule earlier this year, specifically focusing two things: one, food defense is different from preventive controls and two, food defense cannot be prescriptive—it needs to be tied to a facility-specific risk evaluation. While FDA has not yet re-proposed new food defense language as part of the supplementals released on September 29 of this year, we have good reason to believe that FDA has shifted some of its positions in light of our comments. We also believe another opportunity to submit comments on a food defense supplemental proposal, similar to what was done with Preventive Controls, would be a valuable use of time for both the industry and the Agency as they move towards issuance of a final food defense rule in May of 2016.

FST: What are some things that companies need to keep in mind to be prepared to comply with these requirements?

Cooksey: While this is the first time food defense is being proposed as a regulation, there are already some existing training materials available to industry to begin developing food defense plans. Since the requirement to have someone specially trained in food defense will likely be part of the final rule, GMA recommends that companies start early and take advantage of the available materials already available. GMA and the GMA Science and Education Foundation are planning to release additional materials and courses in 2015.

FST: Who should attend this discussion, and how would they benefit from it?

Cooksey: Security specialists at the facility and corporate level regulatory affairs staff who oversee food defense and/or FSMA within their companies should attend. Also, food quality assurance and food safety managers will need to know how the food defense plan will work in combination with food safety plans.

Click here for more information on the Food Safety Consortium, and learn from over 75 of the Food Industry’s top food safety SMEs.

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.

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.

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.