In 2018 FDA published a document titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” commonly known as Appendix 1 to FSMA.
Originally this document consisted of 233 pages and was divided into three organizational sections. The first section explained biological food safety hazards, second chemical hazards and the third one outlined the three known group of hazards related to process and the facility. The old version of the Appendix allowed the users to search for hazards using product’s common names.
Due to the complexity of the document the first draft of the Appendix was considered hard to navigate and misleading. Some of the information pertaining to food sector categories was inaccurate. For example, the Appendix required to consider vegetative pathogens in products that received exceptionally lethal process where those types of food (such as cooked sauces) almost never are associated with vegetative pathogens. The appendix also omitted several chemical hazards such as heavy metals or mycotoxins in certain types of fruits and vegetables.
In January 2023, FDA released the new version of Appendix 1 with significant changes. The content was reduced to 97 pages and foods were grouped into 16 food groups (from bakery items to food sweeteners). Physical and process related hazards were removed from the document and FDA adjusted the methods for searching the Appendix for relevant hazard information. The new version of Appendix 1 lists “inherent” food safety hazards related to food groups. Process and facility related hazards were included in a separate document.
When using Appendix 1, biological hazards are identified by tying in the name of a food group. For chemical hazards the authors included instructions referring the user to the appropriate table outlining those hazards. Appendix 1 requires the user to identify chemical hazards based on components of the food. This means that multicomponent foods will have a lot more of inherent chemical hazards. Bakery items and Snacks have no separate tables for chemical hazards, and you need to search all sub ingredients to have a full understanding on what are chemical agents specific to those products.
Aside from Appendix 1 with inherent hazards included in the 97-page document, FDA published “Process and Facility Related Hazards Checklist”. This 1-page document contains the list of biological, chemical and physical hazards that may originate from the process and are site specific. For biological hazards it requires to consider the potential of pathogen presence due to an infective lethality process, the growth of pathogens due to inadequate time / temperature controls at a process (such as cooling), pathogens growth due to improper formulation that may affect pH and water activity, potential for growth of pathogens due to lack of container integrity in modified atmosphere packing, or improper temperature controls in perishable foods that may cause pathogen growth. It also contains the potential for cross contamination with environmental pathogens such as Listeria Monocytogenes or Salmonella from production environment that is relevant to RTE foods handled after a process step. Under chemical hazards the user must consider mis formulation with high concentration of color, flavor enhancers or preservatives, allergen cross contact from common equipment, and process generated toxic substances in plant-based food operations. Finally, physical hazards originating from structures or equipment such as metal, glass, wood or hard plastic.
The updated Appendix 1 is considered the most comprehensive resource for hazard identification in FDA regulated products covered under Preventive Controls regulation. FDA investigators are trained on using those resource documents when conducting regulatory inspections of FDA regulated food facilities. Those of you that took the PCQI course with BD Food Safety Consultants LLC are familiar with Appendix 1. The new version of PCQI curriculum (2.0) requires that both documents are used when teaching participants the technique of hazard identification. For more information on the Appendix 1 or to register to PCQI training please contact us at https://bdfoodsafety.com/contact-us/