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FSMA: Frequently Asked Questions

Helen Timothy
April 21, 2021

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President Barack Obama signed the Food Safety Modernization Act (FSMA) into law on January 4, 2011. Congress created FSMA to give the Food and Drug Administration (FDA) new powers to regulate and monitor how food is developed, grown, harvested, processed, and manufactured. 

FSMA is the first significant piece of legislation to address food safety since 1938. Additionally, FSMA is the first act to address food defense and intentional adulteration. 

Though the legislation is nearing its tenth birthday, questions remain. Here are a few frequently asked questions and their answers. 

Q: What is the purpose of FSMA?

A: According to data from the Centers for Disease Control and Prevention (CDC), each year foodborne diseases are responsible for almost 50 million Americans getting ill (1 in 6), nearly 130,000 hospitalizations, and 3,000 deaths. It is an entirely preventable public health burden. The government created FSMA to transform the nation's food safety system from one of reaction to pro-action. Instead of responding to food safety crises, FSMA aims at preventing them.

Q: What are the details?

A: There are seven major rules in implementing FSMA. The FDA recognizes that ensuring the safety of the nation's food supply is a shared responsibility. The rules are designed to set clear expectations and outline specific actions to be taken to prevent contamination. The seven rules are: 

  1. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)

  2. Accredited Third-Party Certification 

  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventative Controls for Human Food)

  4. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventative Controls for Animal Food)

  5. Sanitary Transportation of Human and Animal Food (Sanitary Transportation)

  6. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier)

  7. Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense)

Q: FSMA has been around for a decade - where can I go to find updates?

A: The FDA has an excellent website that details any new information surrounding FSMA (temporary policies, revised guidance, new dashboards, etc.). The webpage details all updates from 2011 to today. Find it here

Q: Where can I go to find more information?

A: The FDA is an excellent first place to visit, especially their FAQ page here. Additionally, TraceGains has several resources:

  • FSMA Checklist for Wineries here

  • A Step-by-Step Guide to Implementing a HACCP Plan here

  • Foreign Supplier Verification Program Guide here

  • FSMA for Dietary Supplements FAQ here

  • FSMA for Food & Beverage FAQ here

Navigating the ins and outs of FSMA is a tremendous investment for any organization. Protect that investment with TraceGains Supplier Management. Streamline supplier qualification and sourcing, automate scorecarding, collect and digitize supplier documents, extract data from those documents, and organize it into supplier performance dashboards and reports. Read more about Supplier Management here