5.) What should a Recall Plan include?

According to the rule a Recall Plan is required when you have a hazard that requires a Preventive Control. 21 CFR 507.38 states:

  • (a) For animal food with a hazard requiring a preventive control you must:
    • (1) Establish a written recall plan for the animal food; and
    • (2) Assign responsibility for performing all procedures in the recall plan
  • (b) The written recall plan must include procedures that describe the steps to perform the following actions as appropriate to the facility:
    • (1) Directly notify direct consignees about the animal food being recalled, including how to return or dispose of the affected animal food;
    • (2) Notify the public about any hazard presented by the animal food when appropriate to protect human and animal health;
    • (3) Conduct effectiveness checks to verify the recall has been carried out; and
    • (4) Appropriately dispose of recalled animal food, e.g., through reprocessing, reworking, diverting to another use that would not present a safety concern, or destroying the animal food.

Recalls may be due to feed safety concerns or feed quality issues; they may be mandatory or voluntary.  During PCQI training Chapter 10 taught us the 3 classes of recalls and the requirements of each type of recall. Simply stated, a recall plan is a well thought out series of steps and pre-assigned responsibilities to carry out the steps before the recall occurs. The plan should be practiced periodically, referred to as a “mock recall”. When a real recall occurs, all employees understand their responsibilities and can quickly and decisively carry out the plans step to implement the recall with little or no issues or safety concerns.

A solid plan will define details of each step in the recall process and person responsible for each item

  • Scope of recall by identifying the feed involved, the hazard associated with the feed, including the likely class the recall will fall under.
  • Regulatory agency communication, who needs to be notified: federal and/or state, when they need to be notified and how they will be notified.
  • Recall initiation
  • Customer notification
  • Information and data compilation
  • Document gathering
  • Securing inventory of affected lot(s) in your control
  • Product disposition
  • Documentation

Recalls may be short and simple, for example, one lot of bulk feed delivered to one customer. The issues may be identified early, and all the feed may be able to be retrieved without adverse consequences to any animal.

Recalls may be lengthy and more complex. Maybe the feed was bagged and sold to multiple customers and/or resellers. Maybe the issue was not recognized until all the feed is delivered into commerce and it is more difficult to locate all the feed involved.  

Whatever the situation, a well-designed and practiced plan will make the recall proceed more efficiently than one that must be defined as the situation unfolds.

An example plan is included in the materials distributed during training, I encourage you to make it your own.

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.

3. What should be included in my implementation records?

When an inspector knocks there are certain documents they will ask to see. Some are required by the rule and others depend on the results of your Hazard Analysis and the requirements of the Feed Safety Plan you wrote and implemented. The first “record” you must produce is your written Feed Safety Plan signed by the Owner, Operator, Agent in Charge. We have discussed that extensively.

What other documents and records will be required and/or important to have?

21 CFR 507.4 (b) (2) requires that all employees “Receive training in the principles of animal food hygiene and animal food safety, including the importance of employee health and personnel hygiene, as appropriate to the animal food, the facility and the individual’s assigned duties.” 21 CFR 507.4 (d) requires that “records that document training required by paragraph (b)(2) of this section must be established and maintained and are subject to the recordkeeping requirements in subpart F of this part”. This means these records must be written. Every inspected mill I have spoken to has indicated that inspectors have asked to see training records. Training in animal feed safety and training on Standard Operating Procedures (SOPs) related to their job.

Documentation that your Preventive Controls Qualified Individual (PCQI) has completed Hazard Analysis and Preventive Controls training is also important. Although this training is not required, if your PCQI is not trained, you must be able to prove they are otherwise qualified as a PCQI.

Although records documenting the implementation of CGMP’s are not required by the rule. The next most frequently requested records inspectors ask for are those related to Pest Control. CGMP’s are the minimum standards that must be in place to produce safe animal food and pest control is one of the most difficult of those standards to achieve. It is important to document your success with this requirement.

If your Feed Safety Plan identifies the need for a Preventive Control you will have many required records. When your plan does not require a Preventive Control make sure you have strong justification for that determination in your plan. Records that document your Hazard Analysis and the hazards you considered are important. Tools such as the CFD Hazard Analysis Tool (CFD HAT) would support those decisions and will strengthen your plan.

Other records to support you plan may include:

  • Mycotoxin testing SOP’s and records of test results.
  • Sequencing SOP’s and records that prove the efficacy of those procedures.
  • Medicated Feed SOP’s medication usage and inventory reconciliation records
  • Mixer efficiency tests
  • Scale certifications

This list is not all encompassing but it is important to understand that the more records you have that verify and support your compliance the better your inspection will go.

2. When and why, would I need to reanalyze my plan?

A food safety system changes with time. Periodic reanalysis is needed to verify that the whole system works. The rule requires that you reanalyze your plan:

  1. At least every three (3) years. Even if your plan has not identified any preventive controls, at least every three years you must review your plan to ensure it accurately reflects your operations.
  2. New information becomes available about potential hazards associated with the food. This requirement recalls the need to keep up to date on the levels of Mycotoxins in grains across growing seasons, Changes may require you to increase the frequency of testing and may allow for a decrease in the frequency of testing.  Keeping up to date with industry recalls and incidents of illness or injury will allow you to quickly respond to new threats.
  3. Corrective action and correction, when appropriate. One thing is sure in this industry is that everyday something unexpected will happen. A mill manager once described his job as that of a “short order cook”. When things change frequently you must have processes in place to adjust, fix and repair things when they go wrong. But when this is normal, when things are usually going wrong, it is time to reanalyze your plan and validate and verify its effectiveness.  
  4. Preventive control ineffective. If you have put a preventive control in place to prevent a feed safety issue and the issue to still occurring or is recurring, it is necessary to reanalyze the plan to validate and verify it is appropriate.
  5. Significant change in product or process. You must reanalyze your plan if you decide to make feed for a new species of animal, a feed for an animal in a lifecycle you have not previously produced. Reanalyze your plan if you decide to start pelleting feed or if you install a new piece of equipment that operates differently than the previous equipment.

When you are implementing a preventive control or having issues with its effectiveness…

When you identify corrective actions or are constantly making corrections…

There are two things you need to ask…

Am I doing the right thing? Perform Validation that the process or preventive control is the right thing to do to prevent the problem. Validation requires the use of solutions that are scientifically based and proven solutions.

Am I doing it correctly? Verification requires that you prove the hazard is being prevented. If a process is put into place to prevent a hazard, you must prove that the hazard is not present. Merely trust it is working is not acceptable.

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…