Final Guidance from FDA was issued on 7/8/2022 (click this link to download the document): GFI #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
The draft guidance has been discussed in previous blogs and my PCQI training classes over the last few years. Now that this guidance is final, I highly recommend you read this document and potentially reanalyze your Feed Safety Plan in response to some of the changes. Significant changes in the final guidance are as follows:
- Appendix E: “Aid to Identifying Animal Food Hazards” has been removed. Industry was concerned that the list provided in the draft guidance would lead inspections to expect that each hazard be addresses. Removing this appendix clarified that not all the hazard examples in the guidance are applicable to all animal food or all facilities. Facilities should use the hazard information in Chapter 3 of the guidance as they consider whether particular hazards are known or reasonably foreseeable for their animal food.
- This document provides more concrete examples of when a facility may or may not be required to reanalyze their food safety plan. See section 5.8.6 Reanalysis starting on page 119.
- This document contains more information, resources, and examples of certain hazards in animal food, including information on animal food recalls that occurred since the draft guidance published. This was likely in response to removing Appendix E. Section 2.8 References for Chapter 2 on Page 24 contains links to various resources. As you review the entire document you will see references to many recalls that should be used in evaluating known and reasonably foreseeable hazards in your facility.
If there is any interest in assembling a work group to review this document and the Draft #272 I wrote about in July, I would be open to organizing one. Please email me with any interest in doing so. It could be done in person or virtually via zoom.
A RAQ (Recently Asked Question):
“Can a trailer that hauls bulk commodities such as corn or soymeal also be used to haul hazardous waste?” The short answer is “probably not” but it depends on the “waste” and the “cleaning protocol” that was used after the haul. On this website under “HELPFUL LINKS” you will find a link to the International Database for Transport for Feed. Under “FREE TRAINING VIDEOS” #5 shows you how to use this database and interpret the results. Basically, you search for the material in the previous haul, to identify the cleaning regiment required prior to hauling a feed product. It will tell you if the previous haul prohibits hauling feed. Since this retrieves results from several international standards, which may differ, it would be prudent to use the most restrictive result.