In a much-awaited federal action, the FDA has released an update of its draft guidance for the Preventive Controls/Human Foods (PCHF) Rule, including the highly anticipated revised draft of Appendix 1: Known or reasonably foreseeable hazards (potential hazards), along with a revised draft Introduction.
Reflecting FDA’s current thinking on the most relevant food safety hazards in categories of current interest. Based on comments and concerns over specific hazard-commodity associations and the agency’s use of the Appendix during inspections, the FDA made significant changes including:
- Additional sections and descriptions to better explain the Appendix purpose, development, and intended use.
- Product category revisions to better reflect food ingredients rather than finished products.
- Replacement of process-related hazard tables with a discussion of those hazards.
- An updated discussion on food allergen hazards.
- Citations to scientific, technical, and regulatory information references, particularly for less-commonly known hazards identified for different food categories.
TAG sees to be of particular note in the new issuance of Appendix 1, the listings of potential biological and chemical hazards for 16 commodity types. The previous version had “multi-component foods” as a 17th category, but that is no longer included, likely due to the inherent variability in these kinds of products (e.g., sandwiches, entrees). The expectation is that firms should separately consider the ingredients in each of these products to determine potential hazards.
Also of note is FDA’s transference of information from tables to prose. We’ve been used to seeing this process-related hazard information listed in separate tables, shown by commodity. The new prose format simplifies this, suggesting that there are 14 process hazards that should be considered for all foods and controlled if identified as being reasonably foreseeable:
- Biological hazards
- Bacterial Pathogens
- Presence/growth/toxin production due to survival of a lethal treatment.
- Growth and/or toxin production due to poor time/temperature control.
- Growth and/or toxin production due to poor formulation control.
- Growth and/or toxin production due to reduced oxygen packaging.
- Presence due to ingredients added after process controls.
- Presence, growth, or growth with toxin production due to recontamination due to lack of container integrity.
- Environmental Pathogens – Presence due to recontamination from the processing environment.
- Chemical hazards
- Undeclared food allergens due to incorrect labelling.
- Unintended food allergen presence caused by cross-contact.
- Chemical hazards due to mis-formulation (e.g., sulfites, yellow #5).
- Process-contaminant hazards in certain plant-based foods (e.g., acrylamide).
- Physical hazards
- Metal
- Glass
- Hard plastic
Processors also need to be aware, however, that there may be other process-related hazards that need to be considered for their particular foods and manufacturing setting.
As specifically stated by FDA, “While Appendix 1 is a comprehensive starting point, each facility has the ultimate responsibility to identify the hazards relevant to food manufactured, processed, packed, or held at that facility, such as hazards that are associated with its facility-specific history even though they are not identified as known or reasonably foreseeable (“potential”) hazards.”
The issuance of the updated guidance also includes a revised introduction with an expanded glossary of terms and three new sections on training, references, and resources. The training section provides general information on training relevant to the PCHF rule, referencing certain sections of 21 CFR 117.4 and 21 CFR 117.180, along with the Food Safety Preventive Controls Alliance (FSPCA) standardized curriculum recognized as adequate by FDA. The section also includes a sample list of training topics for personnel other than the PCQI and qualified auditor, noting that these vary as appropriate to an individual’s assigned duties.
Even while the guidance is in draft mode, the new approaches are being incorporated into the revised FSPCA training curriculum, and you should expect that FDA will begin referencing the new guidance in inspections.
We recommend that you take the time to review your hazard analysis and make sure it is on track with the new guidance – and if not, make adjustments. If you are not sure you have time to do the review or need help with the guidance, give TAG a call.
With TAG having representation on the FSPCA Training Curriculum Revision Team, along with a number of certified PCHF Lead Instructors, we can assist in your hazard analysis and general PCHF compliance.
