FSMA 204 is “published:” What You Need to Know

Guest blogger Julie McGill, Vice President of Supply Chain Strategy and Insights, shares insights about the release of the Final Rule for FSMA 204. 

The rule has been "published", but what does that actually mean?

On Monday, November 7, 2022, the FDA updated the website for FSMA Proposed Rule for Food Traceability, noting that the final rule had been published:

The road to FSMA 204 the final rule has been a long one, and there was significant feedback from food industry stakeholders. The FDA added an FAQs section to its website as it received a number of questions from stakeholders, including during public meetings, through the Food Safety Modernization Act Technical Assistance Network (FSMA TAN), and during other outreach engagements. 

The FAQs are based on the proposed rule and its references and were intended to address some of the most frequently asked questions as an aid to those who were considering providing feedback during the comment period.

So where are we in the process? 

September 23, 2020: The FDA published the proposed rule with requirements for additional traceability records for certain foods. 

November 2020: The FDA held a series of virtual one-day public meetings to discuss the proposed rule, FSMA 204 “Requirements for Additional Traceability Records for Certain Foods” issued under the FDA Food Safety Modernization Act (FSMA), and to support the public's evaluation and commenting process on the proposed rule. 

February 22, 2021: With the overwhelming response from the food industry, the public comment period for the proposed rule was extended until February 22, 2021.

November 7, 2022: The final rule was published to the Office of the Federal Register (OFR). 

Mid-November (TBD): Publication is managed by the OFR and the FDA anticipates publication within one or two weeks after the submission date (11/7/22).

FDA Rules and Regulations 

As required by law, the Food and Drug Administration publishes regulations in the Federal Register, the federal government's official publication for notifying the public of many kinds of agency actions. Federal regulations are either required or authorized by statute.  

The final rule explains the regulatory requirements (also known as the "codified" portion), the impact of these requirements on the industry or the public, and responds to the comments on the proposed rule.  

Once the FDA completes a proposed or final rule, but before it is published in the Federal Register, it may be reviewed by other parts of the federal government. In addition, they may consult with non-HHS agencies when working on a rulemaking that has a broader impact. For FSMA 204, the FDA engaged with various industry stakeholders, associations, and standards organizations. 

What You Need to Know About FSMA 204 Compliance

FSMA 204 compliance will require process and operational changes, rigorous data collection, and collaboration with your supply chain partners. Having a solution in place to manage all of this, and ensure compliance is key to your success. 

1. Tech-Enabled traceability is essential for competitive food businesses and provides business value beyond compliance and consumer protection
2. Companies are at risk if they do not understand their role and approach to capturing and sharing enhanced traceability data for high-risk foods
3. The proposed traceability timelines are feasible with aggressive action on the planning and development of digital traceability programs
4. Advanced traceability record keeping is here to stay, this is only the beginning

Choosing a FSMA 204 Compliance Partner

What steps are you taking to ensure FSMA 204 readiness? Schedule time with one of our experts to discuss key components of the FSMA 204 rule and how your brand can strategically prepare for the finalized regulation. We are the leading industry experts in tech-enabled food traceability and your first choice for FSMA 204 compliance support.

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