How do I stay informed about what is happening at the FDA?

This question was asked at the CFD Nutrition and FSMA Conference in December. I get emails from several areas of the FDA. To signup for FDA email notifications, go to:

You will enter your email and create a password in order to make you selections and update them based on your changing professional interests… There is 27 Topic Areas to choose from. Including:

  • Animal Veterinary Health
  • Food & Nutrition
  • Guidance Documents
  • Recalls and Safety Alerts
  • News & Events

The other area relevant to our industry is OSHA. The following link allows you to read or sign up for OSHA QuickTakes – “OSHA’s online newsletter provides the latest news about enforcement actions, rulemaking, outreach activities, compliance assistance, and training and educational resources.”

Do you need a refresher training?

Several of you have called to say that you have had inspections recently. Inspection activity has indeed resumed now that most COVID restrictions have been lifted.

  • Do you have questions following an inspection?
  • Do you need to update your Feed Safety Plan based on the requirement to do so at least every three years?
  • Do you need PCQI Refresher training?

The only Part 2 PCQI training of Animal Food through FSPCA is Virtual and costs $345 or more. If you are interested in attending a class in person at CFD, click here to put your name on a wait list. I would be happy to schedule a class in the coming months.

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The draft guidance has been discussed in previous blogs and my PCQI training classes over the last few years.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 Industry was concerned that the list provided in the draft guidance would lead inspections to expect that each hazard be addresses.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.

4. What if I need a Preventive Control?

First let us look at two definitions:

  1. 21 CFR 507.3 defines a “Hazard Requiring a Preventive Control” as
    • A known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in an animal food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the animal food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
  2. 21 CFR 507.3 defines a “Preventive Control” as
    • Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.

If your Feed Safety Plan identifies a Hazard Requiring a Preventive Control, you will need to use one of 4 classifications of Preventive Controls to control the hazard. These are: Process Control, Sanitation Control, Supply Chain Applied Control or Other Control. The FSPCA Preventive Controls for Animal Food course defines each of these in detail.

In a livestock feed mill the most common type of preventive control is the Process Control. This is a series of steps that are required that will minimize the risk of the hazard occurring. There are four required components to a process control:

  1. Monitoring requires written procedures defining the specific steps to be taken to prevent the hazard from occurring. Employees responsible for monitoring the process must be trained in the importance of the procedures in controlling the identified hazard.
  2. Corrective Actions and Corrections define the specific steps that must be taken should the process fails to control the hazard. This must describe actions that must be taken to ensure that:
    • Appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control;
    • Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur;
    • All affected animal food is evaluated for safety; and
    • All affected animal food is prevented from entering into commerce if you cannot ensure the affected animal food is not adulterated
  3. Validation answers the question… Am I doing the right thing to control the hazard? This requires the documentation of scientific and technical evidence that supports the process selected will control the hazard, when the process is properly implemented.
  4. Verification of Monitoring, Corrective Actions, and Implementation and Effectiveness answers the question… Am I doing it correctly? Are the preventive controls in the Food Safety Plan being properly implemented in a way to control the hazard?

All of these components of the Process Preventive Control must be documented and are subject to the records requirements of the rule.

Sanitation Controls, Supply Chain Applied Controls and Other Controls require some, but not all, of these management components. There is no substitute for the training provided by the FSPCA preventive Controls for Animal Food course to clearly understand the requirements of the rule.

Preventive Controls for Animal Food

Over the past several months we have reviewed requirements for CGMP’s. Next we will review the requirements for Hazard Analysis and Preventive Controls. If you do not have a PCQI on staff or one available to your mill, CFD is offering a class that qualifies individuals as a Preventive Controls Qualified Individual.

When: August 4, 2021 from 8:00 am to 5:30 pm

Where: CFD 380 Broome Corporate Parkway, Conklin NY 13748

Format: Live and in person… Part 2 of the 2-part blended course for Animal Food.

Cost: $300

Details and Registration Link can be accessed here.

Over the next several months, like CGMP’s I will provide an overview of the requirements for Hazard Analysis and Preventive Controls.

Roles and Responsibilities:

FSMA requires all animal food facility workers to be: Qualified Individuals defined as “a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.

FSMA requires that an animal food facility must identify a Preventive Controls Qualified Individual defined as “a Qualified Individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system.”

While this person does not need to be an employee of the facility, they play a major hold in the process of performing the facilities Hazard Analysis, writing and implementing the facilities Feed Safety Plan and overseeing the plan implementation and any identified Preventive Controls.

If your facility does not have a PCQI, act now! If you are a PCQI in need of refresher on the rule requirements, this course is also available to refresh your training.

Future Event: Join me at the 2021 Northeast Agribusiness and Feed Alliance Annual Meeting on August 31, 2021 at Turning Stone. Gary Huddleston (AFIA) and I will present a breakout session on “Safety for the Employee, the Animal and the Consumer”

What I learned at the FSPCA Lead Instructors Conference this month…

  • Inspection FY 2020:
FDA OnlyCGMPHA/PCSanitary TransportationFSVP
FY2020 Domestic Animal Food InspectionsPlanned: 180 Completed: 91 50%Planned: 360 Completed: 7 22%Planned: 84 Completed: 30 36%Planned 75 Completed: 67 89%
The numbers presented at the conference included only FDA inspections:

The time period for the completed inspections was from October 1, 2019 – September 30, 2020, Since inspections were paused in March these were conducted during primarily the first 6 months of this period. The numbers are not surprising, except for FSVP, with almost 90% of the plan inspections completed. This is because the FSVP regulation allows for remote or desk inspections. The others require on-site inspections so COVID-19 had a bigger impact on these types of inspections. Many inspection violations were simply due to the facility not having a Feed Safety Plan and/or conducting the required hazard analysis.

FDA continues to respond to Mission Critical Food Safety Issues. When inspections resumed in July of 2020, FDA developed an Advisory Rating System. They look at the COVID risk in the facilities location and the location of inspectors. Although they did not provide a great deal of information on this process; they have made the unprecedented decision to give advance notice of inspections. They will call approximately 5 days in advance with scripted questions to determine the facilities readiness to safely conduct the inspection.

They are also conducting voluntary Remote Risk Assessments. If you were previously inspected on-site, you may be asked if you would like to participate in a remote assessment of your work towards resolving open issues.

  • The future of training

This conference was for Lead Instructors of Food Safety Training Courses provided by FSPCA (Food Safety Preventive Controls Alliance). Therefore, there was much discussion on training and the opportunities FSPCA has provided to conduct remote training and the rules associated with doing so.  As much as I would love to conduct zoom trainings there is much that needs to be done to gain compliance with the virtual training rules. I have consistently heard from CFD members it is very hard to get things like this done when they are in the mill. I think it would be very hard for students to comply with these new rules as well. As the vaccine has already begun to be distributed, we should be able to resume in-person training in the Spring. I will begin discussions with CFD on the criteria for an in person class.

  • New Tool:  

As I discussed last month, In October FSPCA released this “Abbreviated Guide to Creating a Livestock Food Safety Plan Under the Preventive Controls for Animal Food (PCAF) Rule”. This plan is just an example of a plan for a facility manufacturing Medicated and Non-medicated Feed for Swine and Broilers. Click on the title to view and download the public version of the document.

  • Virtual Office Hours

One idea presented is that instructors are offering virtual office hours. I think this is a fantastic idea and I will be working next week to arrange a schedule for virtual office hours in 2021.  

Coming next month… “A tale of Two Inspections”.  

New Format for FSPCA Preventive Controls for Animal Food Course

FSPCA has announced a new format for delivery of the PCAF Course that is one way to become a Peventive Controls Qualified Individual under the Food Safety Modernization Act. This course is now available in two parts:

Part 1 is delivered on line and requires between 7 and 12 hours to complete.

Part 2 is delivered in a 1 day instructor led classroom setting

Click HERE to learn more. I have developed a few videos to explain the changes and determine if this format is right for you. If you wish you could refresh your understanding of what you learned but don’t want to take the full course again… You can take Part 1 and/OR Part 2 , depending on your needs. CFD will no longer offer the full instructor led course but it will be available elsewhere.

The first PART 2 BLENDED COURSE ON THE EAST COAST IS SEPTEMBER 25, 2019 at Cooperative Feed Dealers.


Preventive Controls for Animal Food
Penn State Extension will be offering a Preventive Controls for Animal Food workshop at the Penn State Extension Mercer County Office in
Mercer, PA on January 29-31.

Upon completion of the entire 2.5 day course, attendees will met the
requirements to be considered as a preventive controls qualified
individual. Current good manufacturing practices, conducting a hazard
analysis, and preventive controls for animal foods will be covered
during the workshop. The audience for this workshop includes
facilities that process, manufacture, pack, or hold animal feed or pet

Register online with any major credit card (MasterCard, Visa, Discover or American Express) at
Registration deadline is January 22.

FSMA Compliance is NOW!

It is hard to believe that 3 years has past since the rules for FSMA were finalized. But today is Monday, September 17, 2018 and this date is significant!

  • All food facilities must be in compliance with CGMP’s. If you or someone you know is planning on filing for an exemption based on the size of the facility it is important to understand that there is no exemption from CGMP’s.
  • Small business must have or be actively engaged in performing a Hazard Analysis to identify Known and Reasonably Foreseeable Hazards. They than must make a determination if they require a preventive control to mitigate those hazards to an acceptable hazard.

Continue reading “FSMA Compliance is NOW!”

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.

Continue reading “Free Sanitary Transportation of Animal Food Training”