Tag Archives: FSMA

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.

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.

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

Two New Proposed Rules. In about a year, it’s HACCP for everybody!

By Rick Biros
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Rick Biros, President/Publisher, Innovative Publishing Co. LLC

Some of the most boring press conferences are when coaches face the press after a game. Most of the questions coming from the press corps are not well thought out. It’s like they are just asking questions just because they can. While the coaches are required to be accessible to the press, I appreciate it when they put some personality and thought into their answers. One time, former Chicago Bears coach Mike Dikta confronted a reporter with “What’s the difference between a three-week-old puppy and a sportswriter? In six weeks, the puppy stops whining.”

The reason some of us watch these press conferences is for the remote possibility the coach actually says something interesting or even better, when they break down under the weight of all the really stupid questions. There was a Coors Light commercial series with coaches completely losing it. Football fans might remember former Indianapolis Colts coach Jim Mora whining “Playoffs?”  See video 

Bill Parcells, former head coach of the New York Giants was classic. Parcells had no patience for stupidity and used to yell at reporters, “That’s a really stupid question. Next question!”

Dr. Margaret Hamburg, Commissioner and Michael Taylor, Deputy Commissioner from FDA held a press conference Friday, January 4 announcing two new proposed food safety rules that I had the pleasure of attending. Hamburg said “This is a very big step in direction of creating a comprehensive prevention-based food safety system.”

The first rule proposed would require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. The rule would also require them to have plans for correcting any problems that arise. A.K.A. HACCP. 

In the past, FDA enforced HACCP in seafood and juice. USDA enforced HACCP in meat and poultry. In about a year, it’s HACCP for everybody! Here’s the link to the rule: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm

The second proposed rule proposes enforceable safety standards for the production and harvesting of produce on farms. FDA is targeting the five pathways of microbiological contamination: water, worker hygiene, soil materials, animals and packing houses – http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm

We are now in a 120-day review period for the two proposed rules. Taylor said, it typically takes the agency about a year to review the comments and issue the final rule.  So, we are looking at HACCP being the law of the land in all segments of the food industry in 2014.

The question food companies need to ask is not what will FDA’s HACCP rule look like in 2014, but how good is our HACCP plan now? Hamburg said the preventive controls rule is basic common sense food safety. Use 2013 as the year to revisit your HACCP plan. When was it last revised? What type of records are you keeping? Simply, if you have a good HACCP plan in place now, regulatory compliance should not be difficult. 

In the press conference, Hamburg said that additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically-produced food, and accreditation standards to strengthen the quality of third-party food safety audits overseas.

Unlike many coaches after a game, Hamburg and Taylor did a good job communicating their points. However, it was the consumer press with their questions that brought to mind how well composed Hamburg and Taylor stayed handling questions such as “How many foodborne illnesses will be prevented if these rules are carried out,” “How much does this cost,” and the best one, “How will FDA make sure farms will prevent wildlife from contaminating fields?” They remained cool and politely answered the questions. I guess they have more patience than me.

That last question made me think, how would Bill Parcells answer that? Picture this old grouchy guy who doesn’t care what anybody thinks of him rephrasing the question: “You want me to tell you how my agency will make sure farms are preventing wildlife from walking through or flying over the fields?? Next question!”

FST Soapbox

The Fiscal Cliff’s Impact on Food Safety Management and FSMA

By Timothy Lozier
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One of the key areas that stands to lose in the fiscal cliff lies in food safety. We may be looking at a food chain that is less safe in 2013 that it is now.

The fiscal cliff is a series of tax cuts that are set to expire at the end of the year. It also would mean that spending cuts would take effect, which would have an impact specifically on Food Safety in the United States.

One of the key areas that stands to lose in the fiscal cliff lies in food safety. If we indeed fall off this fiscal cliff, there will be an 8 percent cut in spending for plant and animal health inspections, equaling about $70 million in cut funding. The Food Safety and Inspection Service agency could stand to lose about a billion dollars from their budget. We are also looking at about $3 million in spending cuts on inspectors. This means less food inspectors in the field, and as a result, less inspections. We are looking at a food chain that is less safe in 2013 that it is now.

FSMA: Still alive?

The other question that comes into play is whether the ever-delayed Food Safety Modernization Act (FSMA) is going to continue its path to law. We all know the delays that the FSMA has encountered since its introduction and passing in 2010. Now that the election is over, the administration seems more committed to the law than ever before.

However, this does not mean that we will see much movement in the coming year. The Office of Management and Budget has stated they plan to release the rules of the FSMA in early 2013, with a 60 day period of public comment. Once that is completed, FDA will take about a year or so to incorporate any public’s comment into the final rule. After that, other agencies will need to review these rules and approve them to actually make it into law.

So, it’s a year for FDA, and a year for other agencies – provided we don’t have any issues (which we will), we’re looking at 2015. More realistically, we’re looking for 2016-2017 timeframe for the FSMA to become a law.

That’s if we don’t see cuts stemming from a fiscal cliff disaster. The Obama Administration seems committed, stating “…We are working as expeditiously as possible to implement the food safety legislation we fought so hard for. When it comes to rules with this degree of importance and complexity, it is critical that we get it right.”

Law or not, food manufacturers are acting now

But whatever the result of government legislation and laws to be enacted for Food Safety Management, organizations are taking the necessary steps today to build processes that foster safer and higher quality food management. The Global Food Safety Initiative’s various schemes (BRC, SQF, IFS, etc.) are currently the gold standard for food safety in the industry today. Companies that are implementing these schemes are taking a proactive stance on food safety, and demonstrating a commitment to promoting safe quality foods in their operations.

Look at Canada

Canada seems to be on the right track these days. Just last month the Canadian government passed their food safety bill into law, which is a sister bill to the FSMA. The new law, which comes in the aftermath of a massive E. coli outbreak at a local farm, has many similar elements to what the U.S. is trying to do with the FSMA. The “Safe Food for Canadians” Act entails:

  • Better traceability in the food system, making it easier to recall products if safety issues arise somewhere in the food chain.
  • New record-keeping requirements for regulated facilities and more powers for inspectors to compel the production of documents in usable formats.
  • Tougher penalties for those who violate established safety standards, increasing maximum fines from $250,000 to up to $5 million, or even higher at the court’s discretion.
  • Registration for all importers, to add a greater degree of certainty to the food safety system.
  • More authority for the Canadian Food Inspection Agency (CFIA) to certify exporters, if required by other countries to facilitate trade.

There’s obviously more to the bill, but the highlights emphasize a tighter control and enhanced visibility to an organization’s Food Safety Management System, and their supply chain.

Take aways

Food Safety is under threat in the United States – spending and budget cuts are going to make a harder environment for promoting Food Safety;

The FSMA is still alive, but there’s a long road before we see any results on the dinner table;

GFSI still remains the key compliance area holding Food Safety processes together; and

Canada has made some movement into promoting Food Safety at the Federal level.

I sincerely hope that 2013 gives us a better view on Food Safety Management than it seems to be right now. But if not, it’s up to the producers to promote their continued commitment to adhering to the compliance standards that help them to operate a safe environment and produce the safest possible products for the food and beverage industry.

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

The Then and Now of Food Safety

By Rick Biros
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Rick Biros, President/Publisher, Innovative Publishing Co. LLC
I just finished reading “Steve Jobs,” the biography by Walter Isaacson, on my iPad, of course! Jobs would have celebrated his 57th birthday on February 24. 
Jobs did not invent many things, but he was a master at putting together ideas, art and technology in ways that invented the future. He was instrumental in changing how we interact with all sorts of content, how we listen to music, interact with our phones, read books and consume content. We still listen to music. We still talk on the phone. We still read books and we still consume content. We just do it differently now. 
Think then and now. What’s the same and what’s different in your life?  
Then, again, think then and now. What’s the same and what’s different in food safety? There are still food safety challenges but how are they different?
In 1993, in the Pacific Northwest part of the US, three children died from eating hamburgers contaminated with E.coli O157; one more child died from being exposed to the bacteria through cross contamination in a day care facility. Sixty people had liver failure as a result of the contaminated food.  
The E. coli O104 bean sprout outbreak in Europe last summer showed us that Mother Nature continues to challenge food safety professionals with new strains of pathogens, this time even more deadly. The statistics from this outbreak are more than 10 times greater than what happened in 1993 in Seattle with more than 60 people dead and over 600 affected by liver failure.
In 1994, the World Trade Organization was established to help countries have improved access to export markets. They identified the need to ensure confidence in the safety of the food supply.  “Quality assurance systems such as Hazard Analysis Critical Control Point (HACCP) system will encourage the food industry and government alike to control food production by concentrating on the critical factors to ensure food quality and safety.”1
Now, we have increased world trade in the food industry, yet today, U.S. food companies tell us that one of their biggest fears is contaminants coming into their facility from foreign suppliers. We’ve got more trade but with even more food safety challenges, though the WTO had hoped to avoid such an issue.
The genesis of Food Quality 
In December 1994, I launched the first trade magazine focused on food quality assurance, Food Quality. We printed 22,000 copies and dropped them in the mail, hoping people would read it. The premiere issue had Moses in a lab coat carrying two tablets with HACCP chiseled on them. I wrote a Publisher’s Column for every issue. Some were pretty good such as “Playing With Fire” which I wrote in December 2003, which warned about the potential of Bovine Spongiform Encephalopathy (BSE) or Mad Cow Disease coming into the North American meat supply because of the continued use of feed with ruminant additives. The column was published 10 days prior to the first case of BSE was reported in the U.S. and was later recognized by the American Business Publication Editors with an award. (Food Quality is now published by Wiley, and since 2009, I am no longer affiliated with it.)
In the 18 years since Food Quality’s premiere, pathogens and contaminants continue to rear their ugly heads with a trail of death and injury in their wake. Have things gotten any better?  
Yes. I believe food safety technology has advanced significantly empowering the industry with the ability to detect contaminants, faster and more accurately. Food safety awareness in the food industry as well as education has increased. Food safety professionals have earned the respect from the C-level suite and are seeing increased support. That’s a big step forward from 1994, however, food safety is a marathon with no finish line in sight and there is still much more work to be done!   
In a conversation I had with Dr. David Acheson this summer, we discussed the state of the food industry and several new food safety “game changers” that will affect the industry. 
  1. Here in the US, the Food Safety Modernization Act (FSMA) is changing the way FDA will monitor and enforce food safety standards and controls. Most of the food industry is unprepared for FSMA. FDA will no longer be an annoying gnat that a food company can just swat away.  
  2. The bean sprout outbreak in Europe last summer was a game changer. What’s the next strain? When will it hit and how hard? 
  3. GFSI supplier audits are all the rage but are they the foolproof tool that food companies can put blind faith into? Perhaps not. The cantaloupe incident last year showed us that. GFSI audits can be good tools when used right. But there is a lot more to supplier controls that food companies need to prepare for… trust but verify!
  4. HACCP is not just for meat, dairy, seafood vertical industries anymore. Thanks to FDA, it will be applicable across the food industry. Yes, many verticals have the same level of knowledge about HACCP that the meat industry had in 1998; i.e. HACCP = Have a Cup of Coffee and Pray!
  5. Severe drought in Texas and the Southwest and unusually wet summers in the Mid-Atlantic sections of the U.S. affects not only agriculture but also food processing. How will this affect supply and quality, and what other impact will climate change have on food safety?   
The food industry certainly has its challenges ahead and there is a growing need for information, education and knowledge, on a global scale.  
Food Safety Tech: A new digital platform
With that said, I am happy to premiere Food Safety Tech, a new digital platform for knowledge and information of food safety, food quality, food business and food sustainability! The goal is to not only provide you with the information you need, but to provide it in one convenient place. While the task at hand of informing the food industry is still the same as it was in 1994, the way we deliver content is more in line with the way people consume content now.  
Using a core team of food industry subject matter experts, editors with both life science and journalism degrees coupled with decades of B2B publishing, events and management experience, we have built Food Safety Tech from the ground up as a new media online solution balancing both the readers’ informational needs along with advertisers marketing objectives.  
When I say subject matter experts, I’m not kidding! Food Safety Tech has some the best names in the industry advising us on editorial topics and direction:
  • David Acheson, MD, Managing Director – Food and Import Safety, Leavitt Partners
  • Gary Ades, Ph.D., President G&L Consulting Group, LLC
  • Jeff Bloom, Executive VP, The Dairy Practices Council
  • Patrick Brown, Senior Director of Food Safety, Rite Aid Corporation
  • Marcos Cantharino, Global Business Director, DuPont Qualicon
  • Mark Carter, CEO, QC Laboratories
  • Jeffery Cawley, VP Industry Leadership, Northwest Analytics
  • Ben Chapman, Ph.D. Asst. Professor, Food Safety Specialist, North Carolina State University
  • Larry Cohen, Food Safety Director, Saputo Cheese U.S.A. 
  • Philip Elliot, Ph.D, Food Safety, Global Quality Assurance, W.K. Kellogg Institute
  • Larry Epling, Divisional QA/Food Safety Manager – FPP, Perdue Farms, Inc.
  • Bryan Farnsworth, VP, Quality Management, Hormel Foods Corporate Services, LLC
  • Jennifer McEntire, Senior Director, Leavitt Partners
  • Steven Niedelman, Lead Quality System & Compliance Consultant, King & Spaulding
  • Kathleen O’Donnell, Chief Scientist, Wegmans Food Markets, Inc.
  • Doug Powell, Ph.D, Professor Food Safety, KSU
  • Mansour Samadpour, President, IEH Laboratories
  • Donald W. Schaffner, Ph.D., Rutgers, The State University of New Jersey
  • Jhana Senxian, President and CEO, Sustainability Guild International, LLC
  • Bill Snyder, Sr. VP, Supply Chain, Hormel Foods Corporate Services, LLC
  • John Surak, Ph.D., Consultant
  • R. Craig Wilson, Assistant VP, GMM, Food Safety and Quality Assurance, Costco Wholesale
With a digital delivery, we are not confined to North America as we were with print. We expect to see the discussions take on a global perspective. There are several benefits of the digital platform and a key attribute is reader engagement.  For example, if you agree or disagree with my opinions in my blog, or any other article on Food Safety Tech, then share them in the comments section.   
Also, you can join in the lively discussions and polls in Food Safety Tech’s LinkedIn group. Currently, there are several discussions with polls including “Is attorney, Bill Marler, a friend or foe to the food industry?” Click to comment and/or to vote. 
You can find us (and friend us) on Facebook and Twitter, where I’ll be tweeting Food Safety Tech eNewsletters and content. 
We encourage you to become an active member of the Food Safety Tech community.  If you are so inclined to write and would like to contribute an article, please contact us through the links at the bottom on the page.  
In order to continue to receive content for Food Safety Tech, please click on this link and become a member of the Food Safety Tech community. Forward to friends as well!
Lastly, Food Safety Tech is more than an eMagazine. We are developing educational webinars as well as conferences. Look for announcements in the next several weeks about our first conference on Supply Chain Vulnerabilities in the Food Industry.
Thank you for the time and attention.  I’m looking forward to the next leg of the journey (with no finish line) and hope that our efforts educate and entertain you along the way. By doing so, Food Safety Tech can fulfill it’s mission to contribute to a safer, better and more sustainable global food supply.
All the best!
Rick Biros