SQF 10 and FSMA 204
How likely is SQF 10 to incorporate the FSMA 204 traceability requirements?
Maybe, but doubtful with the anticipated drastic changes that are upcoming with FDA/USDA and all food safety programs.
I don't think SQF 10 is going to have specific codes that mirror or call out FSMA 204. Rule 204 is too ingredient specific and exemption laden to be listed in the broad scope of SQF's "Food Manufacturing" scope that applies to so many broadly different businesses and facilities, especially given it is a US specific regulation and SQF correlates to Global Food Safety Initatives.
However, SQF makes countless references to a site being required to comply with local and country specific regulations. In product recall 2.6.3, references are made to complying with regulatory bodies outside of SQF and your certifier. If Rule 204 applies to your business and you're not fulfilling the requirements, I could see an auditor making it into a finding.
That said, last time my boss and I discussed, he found provisions written into the FY2025 Ag Bill that basically gutted FDA's ability to enforce Rule 204. It stated no funds are to be used to "implement, administer, or enforce" Rule 204 until FDA "completes at least 4 pilot projects using numerous products on the Food Traceability List, in coordination with farms and food industry members operating [various establishments] to measure the effectiveness of foodborne illness outbreak investigations conducted without requiring tracing to a single lot code and identify and evaluate the feasibility and effectiveness of low-cost tracing technologies." It also stated "extends the compliance date for such rule to at least two years after the date on which the pilot projects are successfully completed..."
BILLS-118-SC-AP-FY2025-Agriculture-FY245AgSubcommitteeMark.pdf - See page 123.
If this ag bill gets passed as it was written and approved out of committee, FDA will need to go back to the drawing board with a couple of pilot projects and then wait two more years to actually enforce. Hard for an SQF auditor to cite you for non-compliance with a law that is prohibited from being enforced.
How likely is SQF 10 to incorporate the FSMA 204 traceability requirements?
It already does with the vague "must comply with all relevant regulation" requirements. Why bother being more specific?
It already does with the vague "must comply with all relevant regulation" requirements. Why bother being more specific?
I have been told by an SQF auditor that they 'can' give you a point and reference that line if they push your eyewash station and it doesn't come on (I asked her why she was pushing my eyewash station paddles during the audit).
So based on that information, and the very small number of items on that 204 list, I wouldn't expect them to need to update the code for it.
Hi AtomicDancer,
As SQF Food Safety Code Edition 9 Section 2.4.1 Food Legislation is mandatory and requires sites to: 'comply with food safety legislation applicable in the country of manufacture and sale. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen, and additive labeling, labeling of identity preserved foods, any other criteria listed under food legislation, and to relevant established industry codes of practice.' I don’t see why SQF 10 would be much different as the code is intended to be universal and applicable worldwide. From SQFI: The SQF Program extends across the globe, with a community of 14,000+ certified sites in over 40 countries across 6 continents.
Also, the compliance date for the Food Traceability Rule is Tuesday, January 20, 2026 and SQF 10 is due to be published in July 2025.
Kind regards,
Tony
It would be difficult to specifically include especially in Module 2 except as Tony-C mentioned referencing federal regulation compliance. I have run into this with several huge customers asking for FDA registration and FSMA compliance information, we are a packaging manufacturer so we're not really even on the FDA's radar (with the exception of 21 CFR 176.170 Components of paper and paperboard in contact with aqueous and fatty foods). There's no need to make a change from the current requirement to be compliant with all local, state, and federal regulations.