New US Legislation - The “REAL” Story on FSMA Preventive Controls for Human Foods (PCHF)

eFOOD-Lab_International_01_2016

The “REAL” Story on FSMA Preventive Controls for Human Foods (PCHF) 16 1/2016 eFOOD-Lab international New US Legislation Background: The US Food & Drug Administration (FDA) regulation on “Preventive Controls for Human Foods (PCHF)” will require all food processors outside the United States that are exporting food additives, food ingredients or finished foods for consumption by US consumers will have to demonstrate complete compliance with this regulation. Author: Allen R. Sayler, CFRS With the September 17th, 2015 formal release by the US FDA of the FSMA “Preventive Controls for Human Foods (PCHF)”, the life of food processing plants, food brokers and exporters of food ingredients changed forever. The regulation is 928 pages long, but the actual requirements that directly impact food plants is much shorter (approximately 40 page). In addition, there were significant new or modified requirements compared to the January 2013 proposed regulation and its September 2014 update. In order to demystify this regulation and its impact on food processing plants, we have created a “Primer” that in a few pages summarizes the September 17, 2015 PCHF regulation. FDA has committed to publishing a “Guideline” sometime in 2016 to also provide added clarity, but its availability may be too late for food processing plants that have to be in compliance by September 17 2016. It is strongly recommended that these plants conduct a thorough review of this “Primer” and contact Allen Sayler at CFSRS (asayler@cfsrs.com) for more information, answers to specific questions or for details on a follow-up webinar (planned for early 2016) to discuss the fine points of this regulation. Timelines The enforcement date by FDA for the various sizes and types of food plants is listed below: 1. September 17, 2016 – plants (large) owned by companies with more than 500 total processing employees 2. September 17, 2017 – plants (small) owned by companies with less than 500 total processing employees but exceeding $1 million in gross food sales per year on a 3-year average. 3. September 17, 2018 – plants (very small) averaging more than $500,000 but less than $1 million in gross food sales per year on a 3-year average. a. Very small plants averaging less than $500,000 in gross food sales per year on a 3-year average are “qualified facilities” and do not have to comply with most of the Preventive Controls for Human Foods regulation, but they need to provide supporting financial information to FDA by December 17, 2018, and then every two (2) years after demonstrating they do not exceed the $500,000 per year gross food sales limit. b. G rade “A” dairy plants making Grade “A” dairy products. Otherwise, Grade “A” dairy plants making non-Grade “A” dairy foods (ice cream, cheese, butter, dry powders) will have to be ready for an FDA enforcement inspection based on #1, #2 or #3 above. Food plant's food safety plan The PCHF regulation requires that each food plant have a written food safety plan available at all times for an FDA inspection. Other written programs and their records must be produced within twenty-four (24) hours of the beginning of the FDA PCHF


eFOOD-Lab_International_01_2016
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