Tech Tip: FSMA Overview

August 26, 2021

Video Transcript

Many times in NEOGEN® technical service will receive calls related to food safety modernization act. And really "What is it?", "How does it applies to what I'm doing today?" and "What might I need to change from a compliance standpoint?"

Just to talk a little bit about some of that history, the FSMA or Food Safety Modernization Act was signed into law in 2011, and in subsequent years rules were released that would allow individual food companies in order to demonstrate compliance with the Food Safety Modernization Act. There's a variety of different rules, each touching on a specific area of food safety. We'd like to talk a little bit about each one.

The major fundamental shift in philosophy was really just one away from what we call HACCP, which some of you in the seafood and juice industry know well, or Hazard Analysis Critical Control Points to now what is called HARPC which is Hazard Analysis and Risk-Based Preventive Controls. The fundamental philosophical difference is that looking at what some of those risks are and then doing our best to project upstream further into the supply chain in order to be able to prevent them from happening in the first place. With that, multiple rules were released that would allow individuals to maintain compliance with Food Safety Modernization Act, which I'd like to go through those individual rules now and what they mean to individual industries.

A large piece of FSMA resides in the first preventive controls rule. That preventive controls rule specifies all sorts of items related to:

  • How to identify individual hazards in a particular facility or in a particular food type
  • How to control those hazards where possible further upstream to prevent them from entering into the finished product
  • How one would go about selecting methodology, validating that that methodology for detection of that hazard is valid and appropriate.
  • How individuals are trained to execute those methods or in this case, for NEOGEN test kits
  • Whether or not they're sufficiently sensitive and you can justify that to an auditor
  • Whether they're fit for purpose in your particular food type, and then
  • Whether or not you have analysts who participate in proficiency programs to demonstrate proficiency in those methods.

It's very all-encompassing related to how to identify hazards how to detect them should they occur and then how to how to identify and properly justify the methods selected for their detection that they're being executed properly and giving good data. It's also the first time that food safety law specifically mentioned the monitoring of food allergens. So it allowed many of our clients to really sort of take a deep inward look about what sorts of hazards that they have available in terms of food allergens, and how they might go about controlling them.

There's also a produce safety rule which specifies for the safe production, growth, harvesting, transport, and storage of produce. There's the sanitary transport rule, which specifies how individuals can certify that their shipping vessels have been properly cleaned and sanitized. There is outside certification that specifies the certification of outside bodies to audit to food safety modernization needs. So to ensure compliance within food safety modernization, there are multiple audit bodies capable of and are certified in order to audit to those standards. There's also mention of certification or accreditation of laboratories who perform outside services. We've seen a large spike in ISO 17025 laboratories for food testing, even within individual food companies that we hadn't seen in the past. In addition there's the food defense rule, which is intended to prevent issues of economic and intentional adulteration that can be problematic when it comes to both safety and value of products that are manufactured. Then lastly with a foreign supplier verification rule, allows individuals to ensure that any suppliers outside of the U.S. are compliant with U.S. standards, as suppliers are imported and then used in finished goods.

Now we fully recognize this can be somewhat daunting if you haven't lived and breathed in this world for the past decade like many of us have. If you ever have any questions, by all means please feel free to reach out. We'd be more than happy to talk with you and if we don't know the answers we can certainly work within our network of professionals within the regulatory industry and food industry to help to get you pointed in the right direction.


Category: Beverage, Prepared Food & Ingredients, Produce, Food Service, Tech Tips