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.

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.

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!

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.