FAQs &
Resources
Find out everything you need to know about the Food Traceability Final Rule by checking out the latest resources, useful links and the most frequently asked questions.
Download Brochure: Everything You Need to Know About FSMA 204
Download our FREE introductory guide which outlines everything you need to know about FSMA 204.
FSMA 204
Compliance Checklist
No matter what stage you occupy on the food supply chain, we can help you get started with our 7-Step Compliance Checklist.
Introducing The FSMA 204 Food Traceability Resource
The FSMA 204 Food Traceability Resource was set up by a group of industry experts to help businesses in the United States prepare for The Food Traceability Rule.
It does this by providing access to clear and up-to-date information, helping businesses understand what they need to do to comply and providing expert compliance and food traceability support every step of the way.
FAQs
Find answers to the most frequently asked questions regarding food traceability and FSMA 204 in our resource section
What is the Food Safety Modernization Act (FSMA)?
The Food Safety Modernization Act (FSMA) is a law in the United States that regulates the production and distribution of food. FSMA tackles the ongoing issue of foodborne illness, a significant public health burden that is largely preventable.
The Food Safety Modernization Act is transforming the nation’s food safety system by shifting the focus of food safety from reactive measures to a preventative approach. FSMA is enforcing new proactive safety measures and increasing transparency throughout the food supply chain.
The Food Safety Modernization Act was signed into law by President Barack Obama in January 2011 and is being implemented by the FDA.
Why is the Food Safety Modernization Act being implemented?
FSMA was set up in response to dramatic changes to the global food system and our understanding of foodborne illness, as well as the realization that foodborne illness is both a significant public health burden, and that it is largely preventable.
Approximately 48 million people get sick from a foodborne illness in the United States (1 in 6 people) every year, with 128,000 requiring hospitalisation and 3,000 deaths annually. This is according to the U.S. Centers for Disease Control and Prevention (CDC).
What is FSMA 204?
FSMA 204, known as the ‘FDA Food Traceability Rule’ or ‘FDA Food Traceability Final Rule’, is a section within the Food Safety Modernization Act that focuses on food traceability and establishing a foundation for end-to-end traceability. “FSMA 204” is informal shorthand for the FDA’s 2022 final rule, Requirements for Additional Traceability Records for Certain Foods, issued under Section 204(d) of the Food Safety Modernization Act (FSMA).
The FDA Food Traceability Rule sets additional food traceability recordkeeping responsibilities for businesses who manufacture, process, pack, or hold foods that are featured on the Food Traceability List. These foods include soft cheeses, shell eggs, fresh-cut fruits and vegetables, fish and seafood, nut butters and ready-to-eat deli salads. These recordkeeping requirements are beyond those outlined in existing regulations.
FSMA 204 aims to more quickly identify the source of an outbreak of a contaminated batch of food and allow more efficient recall, to prevent further spread.
What impact will FSMA 204 have on the food industry?
FSMA 204 is a highly-anticipated FDA requirement that impacts organizations throughout the entire domestic food supply chain and foreign companies producing food for the US.
By mandating comprehensive food traceability requirements, the FDA Traceability Rule affects every level of the supply chain from farmers and suppliers to caterers and the hospitality sector.
By what date do organizations need to comply?
The Food Traceability Rule has already come into effect.
However, the compliance date for all persons is July 20, 2028.
