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The draft guidance has been discussed in previous blogs and my PCQI training classes over the last few years.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 Industry was concerned that the list provided in the draft guidance would lead inspections to expect that each hazard be addresses.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and examples of certain hazards in animal food, including information on animal food recalls that occurred since the draft guidance published.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

Re-evaluation of your feed safety plan is coming soon as CVM issues GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover

In my last series I discussed the main elements required by the Preventive Controls for Animal Food rule (21 CFR 507). At this point all animal feed manufacturers need to have a written plan in place. One criterion for re-evaluation of your plan is when “new Information” becomes available. That would include new FDA guidance.

In May of this year the FDA issued draft guidance on Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover. The introduction states that while the guidance does not significantly change the rules in place since the 1970’s (21 CFR 225) but it will result in the replacement of “prior guidance found in the Compliance Policy Guides Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover and 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds, (both of which we intend to withdraw after this guidance is finalized), but includes updates and additional information.”.

Comments on this new guidance are due by 8/8/2022 and can be made at the website linked here.

This guidance identifies adherence to 21CFR 225, 507 and the Sanitary Transportation of Food as factors in preventing the unsafe contamination of food across the food chain. It addresses several methods for carry-over prevention, specifically: physical cleanout, flushing and sequencing. All these methods should be discussed in your feed safety plan. The guidance discusses in some detail the various life cycle and intended use considerations that must also be addressed in your plans.

This draft guidance document should be reviewed by all medicated feed manufacturers, licensed and unlicensed. Should it be approved by the FDA, this will require that all medicated feed manufacturers re-evaluate their feed safety plans to ensure compliance with the updated guidance and make changes to any identified deficiencies.

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”

Step 7: 507.27 Holding and Distribution

(a) Animal food held for distribution must be held under conditions that will protect against contamination and minimize deterioration, including the following:

(1) Containers used to hold animal food before distribution must be designed, constructed of appropriate material, cleaned as necessary, and maintained to protect against the contamination of animal food; and

(2) Animal food held for distribution must be held in a way that protects against contamination from sources such as trash.

(b) The labeling for the animal food ready for distribution must contain, when applicable, information and instructions for safely using the animal food for the intended animal species.

(c) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute animal food must be examined prior to use to protect against the contamination of animal food from the container or vehicle when the facility is responsible for transporting the animal food itself or arranges with a third party to transport the animal food.

(d) Animal food returned from distribution must be assessed for animal food safety to determine the appropriate disposition. Returned animal food must be identified as such and segregated until assessed.

(e) Unpackaged or bulk animal food must be held in a manner that does not result in unsafe cross contamination with other animal food.

Click here when you are ready to share…