FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

What You Need to Know About FSMA

What is FSMA?

The Food Safety Modernization Act was a piece of legislation that went into effect in 2016. It shifted the focus of food safety from responding to foodborne illness outbreaks towards preventing foodborne illness outbreaks. FSMA updates the requirements for many food businesses who fall under FDA Jurisdiction. FSMA has six major sections:

  1. Preventive Controls for Human Food (Part 117) - Requires processors of human food to develop risk-based systems focused on food safety through prevention. This includes,

  2. Foreign Supplier Verification - Ensures imported food is produced to FDA standards.

  3. Sanitary Transportation Aims to protect food in transportation

  4. Intentional Adulteration (Part 121) - Aims to protect from terrorist acts of contaminating the nation's food supply by establishing "Food Defense" requirements.

  5. Preventive Controls for Animal Food (Part 507) - Requires processors of animal food to develop risk-based systems focused on food safety through prevention.

  6. Produce Safety (Part 112) - Increases the standards of processing produce.

What Businesses Does FSMA apply to?

  • Human food processors

  • Animal food processors

  • Food transporters /shippers

  • Farms

  • Food Importers

  • Food Warehouses / Food Storage facilities

When Does FSMA Take Effect?

FSMA is being rolled out over the course of several years. Smaller businesses have been given longer timeframes for compliance. See the image below for compliance dates.

Timeline of FSMA Compliance Dates

Timeline of FSMA Compliance Dates

Selected FSMA Implementation Dates

Deadline for Preventive Controls for Human Food

  • Very Small Businesses (<$1mm sales/Yr) - 9/17/2018

  • Small Business (<500 employees) - 9/18/2017

  • Large Business (>$1mm sales/yr and >500 employees) - 9/19/2016

Deadline for Intentional Adulteration (Human food):

  • Very Small Businesses - July 26, 2021

  • Small Businesses - July 27, 2020

  • Large Businesses - July 26, 2019


What are the FSMA requirements for my business?

All content on this website is FSMA-aligned and all articles have been updated to reflect FSMA provisions. You can learn about the major provisions of FSMA by reading this summary or browse by category to understand the specific requirements for your business.

The requirements imposed by FSMA have also been integrated into the FDA regulations, so feel free to dive into the Code of Federal Regulations and find your answers.

What is the difference between FSMA and the FDA Regulation?

FSMA is a law that was passed by congress. This updated the FDA regulation, which is a set of rules put forth by the FDA. If your business practices are aligned with the latest version of the FDA regulations, then your business is also FSMA aligned

This website is FSMA-aligned so you don't have to worry about additional FDA requirements.

What are the record keeping requirements for FSMA?

The record keeping requirements for FSMA are outlined in our summary of Part 117 Subpart F

What is a PCQI?

A PCQI is a preventive-controls-qualified-individual. This is someone who has been trained in the risk-based practices required by FSMA. There are many PCQI courses available in-person and online.

All businesses except those exempt from Part 117 Subpart C - Hazard Analysis and Risk Based Preventive Controls are required to have a PCQI to do the following:

  • Prepare the food safety plan and review as necessary

  • Supervise daily production on site.

The PCQI can be a permanent employee for the food processor but is not required to be.