By Guest Author: David C. Kennedy, Ph.D.
The Answer is YES!!!
FSMA mandates a “science-based” approach to food testing. This does not require that Chromatography be used, but in practice, much of the modernization of food testing methods has been driven by the use of new and improved chromatographic (HPLC, GC, and Sample Preparation) applications with the use of advanced instrumentations (UHPLC, Mass spectroscopy, etc). Therefore, improved chromatographic solutions can greatly assist food testing laboratories to reach their method improvement goals and make sure that they are ready for FSMA.
The Food Safety and Modernization Act (FSMA), passed by Congress in 2011, is the first major legislative reform of the Food and Drug Administration (FDA) in over 70 years. It represents a major paradigm shift in the regulatory approach to food safety from “reaction” to “prevention”. Owing to the ongoing globalization of the food supply, the Act has a strong focus on insuring supply chain safety and security. Another underlying focus of the Act is the emphasis on a “science-based” approach to food safety. FDA has already implemented many new regulations in response to the requirements of FSMA, but there are still many more to come. For those organizations and individuals subject to FDA regulations, the looming question is: “What’s next? and What does FSMA mean to me”?
Public Law 111-353 (aka FSMA) consists of 41 statutory sections contained within 89 pages of fine print. Nowhere in this document will you find such terms as GC, HPLC, UHPLC or LC/MS. In fact, if you read the entire Act from end-to-end you won’t find a single mention of the word “chromatography”. However, you will find frequent reference to such terms as “science-based standards”, “science-based strategies” and “science-based documents”. In addition, from an analytical chemistry standpoint, FDA frequently uses the term “scientifically valid method” to define their regulatory interpretation of FSMA requirements. But, so far, still no mention of chromatography. Are we then forced to conclude that FSMA has nothing to do with chromatography and vice versa? On the contrary. My premise – and the theme of this series – is that FSMA and chromatography are intimately related. Stated another way, I believe that the modernization of food safety being sought for in the Act is strongly connected with current and future contributions from the science of chromatography.
However, the association is not obvious and if we want to make the essential connection between chromatography and FSMA, we will have to dig deeper. In future postings I want to build the case for the essential role that chromatography must play in the successful implementation of FSMA. This journey will take many twists and turns, but I believe that as we connect the dots, the picture will become clear. Next time I want to continue the story by taking up the essential concept of “scientifically valid methods”.
So….. Yes…. FSMA Does Equal Chromatography.
Since FSMA mandates a “science-based” approach to food testing and modernization of food testing methods has been driven by the use of new and improved chromatographic (HPLC, GC, and Sample Preparation) applications and advanced instrumentations (mass spectroscopy). FSMA does equal Chromatography.
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About David C. Kennedy, Ph.D.
David C. Kennedy is a Phenomenex Business Development Manager.
He is a graduate of Iowa State University with a BS degree in chemistry and a PhD degree in analytical chemistry. His professional career has spanned over 45 years with a focus on food safety and environmental monitoring. He has had sequential assignments in industrial R&D, contract testing laboratories, and in the manufacture of analytical instrument and consumables.