Kathy Hardee, Esq.
Co-Chair Food & Ag, Polsinelli PC
The new food safety rules under the Food Safety Modernization Act (FSMA) are causing a lot of anxiety among food manufacturers around the country. The deadlines for complying with the new rules are just around the corner. While large manufacturers with more than 500 employees became subject to the rules a year ago, everyone else is expected to comply by the following deadlines.
Human Food Manufacturers: The human food preventative controls rules come into effect as follows:
- Very small businesses: These are businesses which average less than approximately $1M in annual sales – comply by 9/17/2018.
- Small businesses: These are businesses which don’t meet the definition of very small businesses but have fewer than 500 employees – comply by 9/17/2017.
- Larger businesses: These are all other businesses and they became subject to the requirements last September –9/17/2016.
There are certain portions of the rule referred to as supplier chain verification which do not come into play until a somewhat later deadline.
Animal Food Manufacturers: The animal food rule contains two different sections which have different deadlines, one for new current good manufacturing practices (cGMPs) and one for the preventative controls.
- Very small businesses: These are businesses which average less than approximately $2.5M in annual sales – cGMPs – comply by 9/17/2018.
- Preventative Controls – comply by 9/17/2019.
- Small businesses: Businesses which do not meet the definition of very small businesses but have fewer than 500 employees –
- cGMPs – comply by 9/17/2017.
- Preventative Controls – comply by 9/17/2018.
- Larger businesses: All others –
- cGMPs – comply by 9/17/2016.
- Preventative Controls – comply by 9/17/2017.
Fortunately, the FDA has repeatedly emphasized that they intend to work with manufacturers to help them come into compliance. But the FDA will expect to see substantial compliance after these deadlines.
The FSMA rules apply to all manufacturers who are “registered facilities” under the FDA. Generally, this includes everyone except meat, poultry or egg processors (if that is their only product), retail food establishments and a few other small exceptions.
FSMA requires that facilities design a food safety plan. In creating that plan, the facility must first conduct a risk based hazard analysis. Once those potential hazards are identified and the relative risk of each is determined, preventative controls should be designed to eliminate or minimize the risk of hazards. The food safety plan must be managed by conducting monitoring activities, taking corrective actions where necessary and conducting verification. Records must be created at every step and made available to the FDA upon request.
To learn more of the details of what is expected of food manufacturers under the new FSMA rules, join us for a webinar on Thursday, August 24th, 2017. Click here to register for the webinar.
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