Earlier this week FDA released “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” This was officially published in the Federal Register on October 31, 2016. Food Fraud (or EMA) was not directly addressed. This only defines how to disclose hazards (or not). This does NOT provide insight on what hazards actually require a preventive control.
From our Food Fraud Initiative Report (FFIR): <LINK>
This guidance is one of many FDA/FSMA clarifications or statements that are be published in the future. The most important summary or conclusion is for industry to continue to watch for “request for comments” and to submit them. FSMA compliance is being defined by these public engagements.
The review of this guidance identifies the complexity of Food Fraud prevention within a Food Safety regulation. Whether Food Fraud is (or isn’t) a FSMA compliance requirement is an important question, but companies are not just trying to be FSMA compliant – companies are pursuing compliance with all laws and regulations. Food Fraud is a requirement over a range of laws including the Food, Drug & Cosmetics Act. For Food Fraud there are broader certifications or standards that cover the full spectrum of food fraud types as defined in the Global Food Safety Initiative (GFSI) Food Fraud requirements.
Overall conclusions are:
- This guidance does not – and was not intended to – provide new insight on FSMA compliance requirements related to Food Fraud.
- This guidance does not – and was not intended to – provide new insight on what “hazards” require a “preventive control.”
- This guidance demonstrates the complexity–or ambiguity–of addressing Food Fraud prevention in food safety or food defense laws and regulations.
- This does not address broader document fraud.
- When applied to Food Fraud prevention this guidance would seem to be expecting the criminal to confirm there is no criminal act.
Provide Your Comments
We have created an anonymous online survey where you can provide insight or comments. We will use those insights in our formal MSU public comments submitted to FDA. The five questions in the online survey are:
- Do you understand the guidance regarding what and how ‘hazards that require a preventive control’ must be documented?
- Do you have other questions about the guidance?
- Is this process different from what you currently report?
- Are there legal liability concerns with this requirement (e.g. increased legal liability due to the reporting)?
- Do you have other FSMA or FDA questions?
Provide Anonymous FDA ‘Request for Comments’ here:
FDA is making efforts to communicate early and often regarding FSMA implementation. The MSU FFI role is to quickly review and respond to the Food Fraud aspects of these documents. To include more insight we are starting to solicit anonymous feedback from the public. Please use this review for your internal needs or respond to our survey to have your voice heard. JWS.
FDA, Food and Drug Administration, (2016). Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry, Draft, [Accessed October 28, 2016], URL: http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM526490.pdf
FDA, US Food and Drug Administration, (2016). Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; 21 CFR Parts 1, 112, 117, and 507; Notification of availability; Federal Register notice publication, [Docket No. FDA-2016-D-2841], [Accessed October 28, 2016], URL: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-26245.pdf