By now our readers will be well aware of the new laws that FDA has put into effect recently under FSMA (the Food Safety Modernization Act). As an organization, Safe Food Alliance has made it our duty to stay up to date on the latest updates to FSMA, since its inception, and keep our readers informed. In this article we bring you an update on the latest developments in this new set of regulations.
Following the issuance of the 6 final rules in 2015 which apply to the food industry, the FDA indicated their plans to release guidance documents which would help the industry with compliance with these new rules. Over the last few months in 2016 several guidance documents have been released in draft form, giving us some insight into the way that FDA will enforce these new rules and what they will expect food processors to do in order to be considered in compliance with the rules.
The Small Entity Compliance Guide provides useful information for small operations in implementing the new regulation in their facility. The guidance which helps processors understand specific labeling and supply chain requirements under FSMA addresses certain required disclosure statements and will be of interest to processors who sell intermediate products for further processing.
“Hazard Analysis and Risk-Based Preventive Controls for Human Food” is 185 pages in length and describes the process of developing a food safety plan under FSMA. In large part the process described is, in our opinion, very much based on the HACCP approach with some specific items that are unique to FSMA. Some of the material covered is found in the PCQI training that Safe Food Alliance offers, and some of it is supplemental information. However buried at the bottom of the page on FDA’s web site you can find two separately-published items (Appendix 1 and Appendix 3) which may be the most useful of all. Appendix 1, “Potential Hazards for Foods and Processes” specifically lists potential hazards associated with certain food categories.
Appendix 3, “Bacterial Pathogen Growth and Inactivation”, provides information such as time, temperature, and pH, as well as other parameters to help processors manage pathogen risk – including time/temperature combinations which can be used to control Listeria and other pathogens. These data are based on peer-reviewed research conducted over time (a sample is shown below).
| Internal Product Temperature (°F) | Internal Product Temperature (°C) | Lethal Rate | Time for 6D Process (minutes) | |
|---|---|---|---|---|
| 145 | 63 | 0.117 | 17.0 | |
| 147 | 64 | 0.158 | 12.7 | |
| 149 | 65 | 0.215 | 9.3 | |
| … | ||||
Excerpt from table 3-D Inactivation of Listeria monocytogenes.
“Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities” is 40 pages long, and assists food processors in understanding how FDA classifies various activities. This is intended to help processors determine where they fall under the regulations, and may be of key interest to our customers who operate hullers or dehydrators. However in our estimation there isn’t a lot of new information here, it simply spells out in more detail what we already knew.
We look forward to more from FDA in the coming year, and as always we will continue to keep our readers updated with regard to the latest regulatory developments under FSMA. Feel free to contact us if there’s anything we can help you with – whether it’s laboratory, training and consulting, or audits!
