1. How do I conduct a Hazard Analysis?

A hazard analysis is the first step in the process of writing your feed safety plan. In the FSPCA Hazard Analysis and Preventive Controls course Chapter 3 discusses common animal feed safety concerns. But the hazard analysis process outlined in Chapter 5 requires a deeper dive. The hazard analysis required in your feed safety plan must be specific to your facility. The rule states:

21 CFR 507.33 (a)(1) You must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control;

Back in 2015 AFIA recognized that the industry needed help with this process. They worked with the University of Minnesota over a two-year period to publish the “Scientific Literature Database Food for Animals” (version 1.2 April 2017). This database identifies hazards in 16 animal species found in ingredients and finished animal foods. The database scope and inclusion criteria are literature written in English; published in the United States and Canada; and found in FDA recalls over the last 10 years; and other factors. 

CFD used the AFIA database and worked in collaboration with four member livestock feed mills to narrow the scope of the data to six species common to a livestock feed mill in our membership. The CFD Hazard Analysis Tool or “CFD HAT” was completed in 2018.

The rule requires that your hazard analysis evaluate 10 things:

  1. Formulation of the animal food
  2. Condition, function, and design of facility and equipment
  3. Raw materials and other ingredients
  4. Transportation practices
  5. Manufacturing/processing procedures
  6. Packaging and labeling activities
  7. Storage and distribution
  8. Intended or reasonably foreseeable use
  9. Sanitation, including employee hygiene
  10. Other relevant factors, such as temporal (weather-related) nature of some hazards

The CFD HAT begins your analysis of Raw Materials and Other Ingredients and the Intended or reasonably foreseeable use of the feed you manufacture. By evaluating hazards found in finished animal feeds, it also provides a window into the hazards that could originate from the manufacturing process. Use your process flow diagram to complete the process of hazard analysis.

The rule further requires:

21 CFR 507.33 (2) The hazard analysis must be written regardless of its outcome

It also requires that you document hazards that are known to our industry (Chapter 3) but do not rise to the level of a known and reasonably foreseeable hazard that is addressed in your feed safety plan.

For example, Bovine Spongiform Encephalopathy (BSE) is not prevalent in the United States and BSE is not cited in the source database for this analysis. It should still be documented as a hazard that was considered but not found to be Known and Reasonably foreseeable. A paragraph in your feed safety plan and copies of you last FDA Inspection reports (demonstrating compliance with 21 CFR Part 589.2000 and 21 CFR 589.2001) would fully demonstrate the mitigation of the hazard. Reference to the World Organization Resolution No. 26 (85th General Session of the World Assembly, May 2017) indicating the United States has a negligible risk of Bovine Spongiform Encephalopathy would also be appropriate. Therefore, it is not a Known or Reasonably Foreseeable Hazard. If your facilities BSE inspection was not successful, the hazard may be elevated to a Known or Reasonably Foreseeable Hazard and be addressed in your feed safety plan.

Pesticide Contamination is also a hazard that has not risen to the level of a known and reasonably foreseeable hazard. This week the FDA issued the FY 2019 Pesticide Report, Noting that it is “Consistent with Trends Over the Past 8 Years, Pesticide Residue Levels Remain Low“. The report can be found here: Pesticide Residue Monitoring Program Report for FY 2019. In your next update to your Feed Safety Plan a reference to this report would be appropriate.

If you would like more information on the CFD Hazard Analysis Tool (CFD HAT). Email [email protected].

Can I see your Feed Safety Plan?

Earlier this year I wrote a series of blogs on Current Good Manufacturing Practice. Compliance with these practices is the foundation for manufacturing safe animal feed. If you have not already been inspected by FDA for compliance with CGMP’s, inspections have resumed and you should expect one at any time. It is also likely that future inspections will include your compliance with Hazard Analysis and Preventive Controls. Are you ready for the question, “Can I see your Feed Safety Plan?”?

This document must be written, current and contain the following required elements:

  1. Hazard Analysis
  2. Reanalysis
  3. Implementation Records

If Your Hazard Analysis identifies a Hazard Requiring a Preventive Control, it also must include:

  1. Preventive Controls
  2. PC Management Components
    1. Monitoring
    2. Corrective Actions and Corrections
    3. Verification
      1. Validation
      2. Verification of Implementation and Effectiveness
  3. Recall Plan*

*Although the rule only requires a Recall Plan when you have a Hazard requiring a Preventive Control, I strongly encourage you to have a plan in place as a good business practice.

While the following background information is not required, it would be in your best interest to include the following elements to tell you safety story:

  • Food Safety Team members (identify your PCQI)
  • Facility Overview
  • Flow Diagram

Again, if you participated in the FSMA CGMP Program, all these optional components and a Recall Plan were included in your materials.

Over the next several months, I will post answers to the following questions:

  1. How do I conduct a Hazard Analysis?
  2. When and why, would I need to reanalyze my plan?
  3. What should be included in my implementation records?
  4. What if I need a Preventive Control?
  5. What should a Recall Plan include?

If you have a question you would like added to this list… email me at [email protected]

If you do not have a written plan or if you do not have a Preventive Controls Qualified Individual (PCQI) on staff in your facility to write this plan, consider training someone to be a PCQI. While there are no classes scheduled at CFD at the moment, there is a wait list for a class you can add your name to: https://fsma.cfd.coop/training/

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”

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.

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.

Do you know for sure?

Do you know for sure that your sequencing and flush procedures for medications work? How do you prove it? Many tell me… “it must work because I have never had a problem”… Is that still good enough?

Now that FSMA is here… it is not enough…

So how do you prove it? Elanco can help help… Rumensin has a micro tracer technology built into the product and Elanco provides the test kits for free. There are two types of kits…

1.) Mason Jar Kit – Give a simple YES or NO answer to the question “is there Rumensin in my feed?”. It’s easy to conduct and can be used to prove your sequencing and Flush procedure works!

2.) Rotary Test Kit – Goes a step further and will tell you how much Rumensin is in a feed. It is slightly more complicated to conduct but if you need the answer to how much is there this is a quick way to get the answer without waiting for the lab report.

If you are interested in learning more about this technology, email me at [email protected] and I will refer to the appropriate Elanco rep to help you out…

AFIA Reminds Members of Expectations for HA/PC Inspections, Clarifies Investigator Process with FDA

Most of the feed mills that subscribe to my posts are small facilities and not currently subject to inspections of Feed safety Plans.  This article published by AFIA reminds large facilities what to inspect when FDA knocks to do a Feed Safety Plan inspection. It has valuable information you need to consider as you continue to prepare your Feed safety Plan. In the coming months you may get a CGMP inspection. Remember while the FDA is not inspecting small facility feed safety plans you are required to have one in place. I have bolder the part that i have been preaching for almost 3 years now. Please read this important information…

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