An Important Part of Food Safety Certification
As Director of Quality Assurance at FoodReady, I many times make site visits to our enterprise clients so I can prepare them for a safety certification or food safety audit, while there I am often asked the question – What is FSMA? Why is it necessary for our food supply?
FSMA is the federal Food Safety Modernization Act, signed by President Obama in January of 2011. The purpose is to ensure the U.S. food supply is safe by shifting the focus from responding to hazards in our nation’s food supply to preventing them (fda.gov/Food/GuidanceRegulation/FSMA/). According to data from the Centers for Disease Control (CDC) 1 in 6 people in the United States or around 48 million people get sick each year from unsafe food.
Before I started my career as a PCQI, certified in HACCP, SQF, I experienced food poisoning (something I wouldn’t wish on anyone) and now I absolutely know why a good Hazard Analysis and Critical Control Points (HACCP) plan, (SQF) certification Safe Quality Food, Good Manufacturing Practices (GMP) or recall plan is so vital to a food manufacturer, packaging manufacturer, co-packer, restaurant, grocery store, deli or startup. We all want to be successful and now more than ever a bad review due to someone experiencing an illness due to poor food safety practices can be a business killer. Getting the proper food safety certification really pays off financially.
Think about that for a moment and let me get back to explaining what FSMA is. FSMA primarily governs manufacturers and their ingredient suppliers at home in the United States and ingredients imported from overseas, which in turn supplies restaurants, grocery stores like Costco, Whole Foods, Kroger, Walmart, commercial kitchens and delicatessens , so the FSMA really is the start of where our safe food comes from.
First off there are seven foundation rules with FSMA, all under the jurisdiction of the FDA. All seven rules were published from September 2015 to May 2016 with unique compliance dates. At FoodReady we have focused on the rule for the manufacture of human food. The preventive controls for human food final rule requires a written food safety plan, record-keeping, a recall plan, and oversight by a PCQI which stands for Preventive Controls Qualified Individual.
Final rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Who is governed by FSMA? Human food manufacturers and whoever supplies the ingredients.
When is compliance?
All facilities should be compliant by now, but let’s break it down.
The initial compliance date was in September 2016 for large businesses. The FDA categorizes large businesses as “other businesses” and they have more than 500 employees.
Small businesses (less than 500 employees) had a compliance date of September 2017.
Very small businesses are qualified facilities (less than 500 employees and less than $1,000,000 in annual sales and holdings), or subject to the Pasteurized Milk Ordinance. All of these have compliance dates after September of 2016.
Very small businesses are qualified facilities. Having a designation as a qualified facility exempts the facility from the hazard analysis, preventive controls and supply chain requirements. The business is still required to follow Good Manufacturing Practices, provide attestations in support of their status, provide evidence of oversight and compliance in their location, maintain records, and provide evidence of status annually.
Even though a qualified facility is not required to conduct a hazard analysis and identify preventive controls for those hazards, the qualified facility is required to state how they are controlling hazards in their process. In other words, what is the qualified facility doing to make their product safe for the consumer? If a very small business believes they are a qualified facility, their status records must already now be in place.
Businesses subject to the Pasteurized Milk Ordinance (PMO) had a compliance date of September 2018. These grade A milk processors come into compliance after the next revision of the PMO is published. The PMO will include elements of preventive control requirements.
Here listed is the summary of FSMA:
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