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.
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 the FDA that a company has achieved compliance, a food company needs only to understand what the FDA inspectors will expect 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 US, there will be just a handful of basic requirements.
Indeed, if you are a food company, and if you source your ingredients domestically, you will only be required to show: (1) that you have a written food safety plan; (2) that you have records to prove that you are following your written food safety plan; and (3) that you have 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 the FDA (when the 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. Finally, 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.” More on that later.
As noted, the real 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, the FDA can immediately trace the product back upstream, and then quickly identify, contain and then solve any potential problems.
So long as your program enables you to accurately and quickly accomplish these goals, the FDA will likely characterize your program as compliant.
Next, as noted above, 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 to perform some type of microbiological testing to verify the effectiveness of their programs and the quality of the products they are shipping. Oh, and 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 attempts to capture the “essence” of what FSMA requires, I would not be doing my job as a lawyer if I didn’t 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 the 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. Put simply: 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.