According to the Food and Drug Administration (FDA), food borne illnesses each year make 48 million people sick. Out of that group, hospitalization happens for 128,000 people and 3,000 people die. FDA hopes that the successful implementation of FSMA (the Food Safety Management Act) will help reduce food borne illness — which it considers largely a preventable public health problem — in the food & beverage industry. 

FSMA has five key areas of concern:

  • Preventive controls across the US food supply to prevent these problems
  • Inspections using innovative inspection methods to ensure industry compliance
  • New tools with respect to food imports, including accrediting third-party auditors to certify that foreign food businesses conform to US food safety requirements
  • Recall authority over all US food although FDA expects its requests for voluntary recalls to work in most cases; FDA now has increased power to detain products that are potentially a problem and can suspend registrations of offending facilities
  • Cooperation between all levels of government’s food safety agencies and to improve training of food safety officials at all levels of government

That all sounds more like food producers than food & beverage establishments. How does the law affect my business? Restaurants are not subject to most provisions of the law — but there’s a big caveat to that statement. If you directly import food from outside the US to cook and then sell in your establishment, then you are subject to the food import rules.

And if I’m not an importer, why should I care about these rules? It is wise for all food chain businesses to understand the basics of the new food safety rules. After all, you want to know that the people from whom you buy food to sell in your restaurant are following safe food practices.

So, what are the final rules as they relate to food chain businesses (not farmers or food producers)? 

To assist food chain businesses, the FDA issued these final rules:

  • Food facilities must put in place procedures to identify and minimize human food hazards. 
  • Importers must certify that growers produced the imported food under the same production safety rules as US food producers. 
  • FSMA requires the transport of food to comply with food safety sanitation requirements. 
  • FSMA requires foreign and domestic food facilities to fix vulnerabilities in their processes to prevent terrorist acts intending widespread harm.

When do businesses have to comply?  FDA staggered operational compliance deadlines over several years following the date FDA published the final rules. If you are a very small business (defined as less than $1 million per year in annual sales of human food), the compliance date is within three years after the final rules. If you are a small business (fewer than 500 employees), the compliance date shrinks to two years after issuance of the final rules.

FDA issued additional compliance date extensions and clarifications which are outside the scope of this post.  

How do we know if the growers of imported food followed USFDA rules? You would request a third-party certification that the growers followed USFDA food safety rules.

Food safety training is available to assist you with FSMA compliance.  FDA acknowledges it has a role in facilitating the training that food industry businesses must obtain to comply with FSMA. Toward that end, FDA created the Alliances which are public-private entities funded by FDA. Training is currently available through the Alliances.  

  • Food Safety Preventive Controls Alliance, started in 2011, coordinated by Illinois Institute of Technology’s Institute for Food Safety and Health.
  • Sprout Safety Alliance, started in 2012, coordinated by Illinois Institute of Technology’s Institute for Food Safety and Health.

The FDA anticipates that the only food safety training through the Alliances and developed through cooperative agreements are the only ones that FDA will recognize. So, if you are thinking of developing your own training course, FDA recommends that you work with the Alliances to make sure the training is consistent and thorough.

Where can I get additional information on FSMA? FDA has produced several Fact Sheets to facilitate compliance with the final rules and to foster understanding of the rules.  You will find Fact Sheets on accrediting third-party auditors, foreign supplier verification programs, protecting food against adulteration, preventive controls for human food, preventive control for animal food, sanitary transportation for human and animal food, and standards for produce safety.

In addition, FDA published several presentations on its website including the overview of FSMA and the proposed rules.

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