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In May of this year the FDA issued draft guidance on Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover.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This draft guidance document should be reviewed by all medicated feed manufacturers, licensed and unlicensed.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.
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
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.
First let us look at two definitions:
- 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.
- 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:
- 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.
- 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
- 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.
- 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.
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.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
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.
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!”
Last week I attended the 2018 FSPCA Lead Instructor Conference for instructors of FSMA Food Safety Courses. As in last years conference I always learn something new. Here are some highlights for Animal Food. Just a reminder that there are two more dates to remember in terms of compliance: Continue reading “What did I learn at this years FSPCA Instructor Conference?”
Today is the day we have all been working towards.
- If you are a CFD member who has participated in the CFD FSMA Program you are well on your way towards this compliance (assuming you are working on implementing the program we developed).
- If you have taken the FSPCA Preventive Controls for Animal Food Course (taught by CFD or others) you learned that today is the day you are required to be in compliance with training (Sub-Part A) and cGMP’s (Sub-Part B). The course explained many of the things you need to do.
- BUT IF
Continue reading “Small Business FSMA Compliance date has arrived”