GFI#245 is Final and RAQ (Recently asked Questions)

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The draft guidance has been discussed in previous blogs and my PCQI training classes over the last few years.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 Industry was concerned that the list provided in the draft guidance would lead inspections to expect that each hazard be addresses.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and examples of certain hazards in animal food, including information on animal food recalls that occurred since the draft guidance published.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.

FDA Provides Update on FSMA Inspections

The following is an update on the number and type of inspections of Animal Food Facilities have been completed by the FDA as of July 11, 2019. The remaining planned inspections are slated to occur between now and the fall (end of Federal Fiscal Year).
1.) CGMP by FDA – 136 complete of 250 planned
2.) CGMP under state contract – 222 complete of 371 planned
3.) HA/PC by FDA 51 of 150 planned
4.) HA/PC under state contract 12 of 68 planned
5.) FSVP by FDA two of 25 planned
6.) Sanitary Transpiration – 20 of 45 planned
Inspection findings continue to to include (in no particular order):
1.) Lack of keeping accurate records
2.) not maintaining equipment and buildings in a clean and orderly manner
3.) Improper labeling feed intended to be reworked
4.) Ineffective pest control.

Free Sanitary Transportation of Animal Food Training

More free videos for training on the Sanitary Transportation of Animal Feed have been posted to the Free Training Video page.

#4 – Sanitary Transportation of Animal Feed – Target Audience is Transportation Companies hauling grains and animal food.  

If your third party carriers are reluctant to haul grains and feed due to the regulation that went into effect in April this 9 minute video will tell them what they need to know. Please feel free to send them to this site for this important training.

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Sanitary Transportation of Human and Animal Food Training Update

Following the FSPCA Preventive Controls for Animal Food Training, I give a short introduction to the Sanitary Transportation of Human and Animal Food rule. This is one of four FSMA rules the Animal Feed Industry must comply with. In July I learned that the FDA was creating web based training on this rule and that training has been released this week.

Who should take this training?

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Inaugural FSPCA Lead Instructor Conference Feedback

On July 13 – 14 I attended the first FSPCA Annual Conference for Lead Instructors of the Preventive Controls for Human and Animal Food courses. The conference included a series on presentations and panel discussions focusing on Industry needs for information, training and support to implement the Food Safety Modernization Act. If I tried to convey all I learned in this blog post you would likely not read it so here are the highlights:

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International Database for the Transport of Feed

The thing I value most about teaching the FSPCA Preventive Controls for Animal Food course is what I learn from participants. In the most recent class I was privileged to have two students from an international third party certification company. During discussions on Receiving cGMP’s and the Sanitary Transportation of Animal Food, the inevitable questions on what are acceptable clean out protocols for materials previously hauled and what is strictly prohibited. The student referred us here:

International Database Transport for Feed

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Sanitary Transportation of Human and Animal Food

21 CFR Part 1 and 11 – Sanitary Transportation of Human and Animal Food Final Rule was released April 6, 2016.

The following paraphrases information published by the FDA on April 5, 2016 at

This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect feed.

* Remember “food” includes “animal feed” and I have changed the word “food” to “feed”

Key Requirements

  • Vehicles and Transportation Equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the feed that it transports to become unsafe.
  • Transportation Operations:The measures taken during transportation to ensure feed safety, such as adequate temperature controls (if required for feed safety), protection of feed from contamination by non-feed items in the same load or previous load, and protection of feed from cross contamination. This section defines roles in the transportation operations for Shipper, Loader, Carrier and Receiver all with different responsibilities.
  • Training:Training of carrier personnel in sanitary transportation practices and documentation of the training.
  • Records:Maintenance of records of written procedures, agreements and training (required of carriers).

This applies to inbound and outbound shipments. If you arrange the freight on inbound shipments or if your company delivers feed on company vehicles there are compliance requirements.

Compliance Dates:  April, 2018

Exempt from the Rule (this is a narrow list of exemptions that could apply in the feed industry)

  • Shippers, receivers, or carriers engaged in feed transportation operations that have less than $500,000 in average annual revenue
  • Transportation activities performed by a farm
  • Transportation of human food byproducts transported for use as animal feed without further processing
  • Transportation of feed that is completely enclosed by a container except a feed that requires temperature control for safety
  • Transportation of live food animals, except molluscan shellfish

Bottom Line: If you transport Bulk Feed, you need to address this rule in your SOP’s.