A Guide to the Food Safety Modernization Act FSMA

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, and 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 require 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. Having a designation as a qualified facility exempts the facility from 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, its 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:

• • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
    • • This is the animal food rule.
    • • Who? Animal food manufacturers and their ingredient suppliers
    • • When? The initial compliance date was on September 2016
    • • In the same way that food for human consumption must be made in a safe manner, the diverting of human food to animal food and the production of animal food must be done safely.

• • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
    • • This is the import rule.
    • • Who must be compliant? Importers of ingredients or food for humans or animals
    • • When? The initial compliance date was on May 30, 2017
    • • To see descriptions of other compliance dates, reference this FDA document here

• • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
    • • This is the produce rule.
    • • Who must be compliant? Raw agricultural commodity farmers
    • • When?
        • • Produce growers with more than $500,000 in annual sales must have been compliant as of November 2017.
        • • Small businesses with annual sales between $250,000 and $500,000 must have been compliant in November 2018.
        • • Very small businesses with annual sales between $25,000 and $250,000 must be compliant in November 2019.
        • • Due to high risk, sprout growers must have been compliant in November 2016, with small and very small sprout growers compliant in November 2017 and 2018, respectively.
        • • Covered growing (excluding sprouts) has compliance dates ranging from 2018-220 depending on the size of the farm.

    • • Many commodities are exempt from parts of the rule due to the nature of the specific crop being grown. Growers may have different compliance dates for parts of the rule such as testing, water quality standards, and recordkeeping; labeling; or retention of records supporting eligibility for a qualified exemption.

foodready.ai is a food safety software and consulting company. Our software has a HACCP builder, food traceability, you can create your own checklists to manage your HACCP plan or track other items, ingredients, tasks, or events. With our Enterprise program you will have access to food safety quality assurance professionals who can help you with GFSI, SQF, GMP, SOP, BRC, CGMP, HACCP, gap analysis, or prepare for audits like the Costco audit, the Whole Foods audit, Publix audit, Kroger audit, Safeway audit, Meier audit, HEB audit and more.