Category: Inspections

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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.

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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/

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A Tale of Two Inspections

I recently spoke with two feed mills that I have worked with in different capacities over the years. Each has recently had a FSMA inspection. Without divulging the identity of either mill I would like to summarize the key parts of each inspection:

#1 – FDA conducted this inspection just prior to the March 2020 COVID pause.

  • Our FDA Investigator was very thorough. He first read through all our programs and then toured the Mill Operations. 
  • Next, he came back and started going through records to match up with what we said we were doing in our programs.
  • He was very meticulous in matching up employee training records and what our CGMP program said we would train for. 
  • He then looked for records to see if the individual that was trained had filled out documentation according to our plan.
  • He concentrated on our CGMPs and their supporting pre-requisite programs. 
  • He focused in detail on our pest control program. Looking for trending reports and recommendations by our pest control technician and our own internal walkthroughs.  He did his own physical inspection and found no issues.
  • He was also very interested in all training that was done by our company.
  • He looked at “Sanitary Transportation”: training records, testing, and certificates of completion.
  • He looked at our Hazard Analysis, Flowcharts, and Feed Safety Program and no deficiencies noted.
  • “All in All… it was not a bad experience.” 

#2 – PA Department of Agriculture conducted this inspection in December 2020 on behalf of the FDA. It was a combined inspection for VFD, non-licensed medicated feed and CGMP’s. It did not include Hazard Analysis and Preventive Controls. 

  • For the VFD inspection he selected 3 random orders and went over the paperwork in detail.
  • For the non-licensed medicated feed inspection, he reviewed all our required medication logs.
  • He had notes from a previous state inspection and went over the issues identified in that previous inspection to determine if recommendations were corrected.
  • He asked a long list of questions about CGMP’s and took notes on my answers.
  • He then toured the entire facility from top to bottom to confirm we are doing what we say we are doing. 
  • He focused on housekeeping and pest control. We do pest control ourselves and he was looking for records.
  • He was very interested in any, and all logs we keep.
  • He asked about training since we have had several new employees recently.
  • Although it was not the purpose of this inspection, he asked if we had begun our Hazard Analysis and if we are working on our Feed Safety Plan. He indicated that the state has contracted with FDA for a very limited number of these inspections, but we can expect one in the next couple of years.
  • He was here for about 4 ½ hours.
  • “We have not received our report yet, but I feel it went better than I had anticipated”.

It is difficult to comment on the differences in the inspections because the purpose of each was different. There are similarities and for the most part they included all the elements that we were told to expect from an inspection. Both mills felt like the “educate while they regulate” was indeed what they were doing. They hope this information is helpful.

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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”.  

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“I am NOT from the Government, AND I AM here to help” – Barbara Simeon

Not to get “political” in these “overly political” times but, I will modify a quote from President Ronald Regan – “I am NOT from the Government, AND I AM here to help”.  

It is my pleasure to return to CFD as a part-time consultant to support members and customers navigate the requirements of the FDA, as it relates to FSMA. As you may know, I returned to my previous position at a local non-profit as their Finance Manager, a little over a year ago. While I still hold this position as my full-time career, I have remained in touch with several members. I have helped a few by answering questions and assisting in the preparation and review of Feed Safety Plans. After discussion with the Board, Lon and Eric, I am reprising my role primarily updating the CFD FSMA website and publishing this newsletter. I am committed to keeping YOU up to date on all things FSMA by working with AFIA, staying connected via the FDA and focusing on your needs.

I hope you will take a moment to read through this update and reach out to me, so I know how to help moving forward…  

I will pick up in 2020 where everything starts… with COVID-19. We all look forward to the day when our lives no longer revolve around this pandemic. As I read though the many industry updates over the last 6 months, COVID-19 looms large. As many parts of our world paused, agriculture pushed forward along with the first responders, medical professionals and other essential services. That is not to say there has been no impact to the industry. This industry has had more than its fair share of hard time but is uniquely positioned and steadfastly determined to weather this storm. Here is some valuable information I would like to share.

1.) Northeast Agribusiness and Feed Alliance (NEAFA) posted a webinar on stress management held on April 29th. If you have not seen it I recommend finding a quite corner, a cup of coffee, put your feet up and watch it. Kudos to NEAFA for addressing the social emotional health aspects of these times even before it was the buzz.

2.) AFIA (American Feed Industry Association) continues to be on the front lines of information dissemination from Washington. That has certainly been difficult during these times. As the pandemic has unfolded, there has been good and bad information shared. I am particularly impressed by a document published in collaboration by the FDA and OSHA. The Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic. It is a well thought out document with good guidance on protecting your employees and the safety of the food supply. This pandemic has been and continues to be an event that requires reanalysis of your Feed Safety Plan. COVID-19 is not transmissible through food. It is unlikely to be transmitted from contact surfaces. This does not mean it is not a threat to food safety. As outlined in the middle of page 11 through page 12, you must consider the very real impact the pandemic has had on supply chain interruptions and your trained workforce. Should you experience a case of COVID-19 in your workforce, your ability to produce feed could be significantly reduced and even eliminated should the virus spread to key employees. While hiring a temporary workforce is feasible, the lack of trained staff is a risk that needs to be well thought out. Page 13 – 15 details the 8 CGMP’s and things you should consider in mitigating the risk. If it hasn’t happened yet, and I hope it hasn’t, the latest increase in numbers nationally and locally should give you great pause.

3.) FDA Inspections were all but halted in March due to COVID-19. In July the FDA announced a plan to restart them and is working towards that end. In the next installment of this newsletter, I will provide an update on inspections held to date and what to expect moving forward.

4.) Last but certainly not least, a reminder… All Food Facilities (including animal food) must register as such with the FDA in even years between October 1 and December 31. As we stated in 2018, it remains CFD’s opinion that all CFD customers of pet, animal or human food products we sell are required to register. This Biennial registration renewal began back in 2012 so this should be the fifth time you have done so… but in these times with so much on our plates it begs a friendly reminder… 

CLICK HERE TO RENEW FDA REGISTRATION

If this is your first time registering, click here for a list of information you will need to collect in order to do so.

In closing, I look forward to working with each and everyone of you. I am asking that you reach out to me with: Your questions. Your concerns. Your needs. If you need FSPCA Preventive Controls for Animal Food Training, we are open to holding a class in 2021. It could be for a certificate or a refresher. If you have completed your feed safety plan, I am open to reviewing and commenting on the plans. If you have not yet completed your plan, let me know what issues you are having in doing so.  I AM here to help – Barbara Simeon ([email protected])

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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.
 

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AFIA posts about… FDA CPGs withdrawal…

FDA Withdraws CPGs Related to the Use of Rendered Products in Feed, Pet Food

AFIA published the following information on Tuesday April 30, 2019. It is re-posted with approval…

In response to a citizen petition, the Food and Drug Administration withdrew three compliance policy guides (CGP) today that dictate how certain animal-derived food materials can be used in animal food. The FDA said the action will “clarify” for animal food manufacturers the agency’s regulatory policies and expectations for the use of materials from dead or downer animals.

Since the CPGs were issued 40 years ago, FDA said its “knowledge of, experience with, and focus on preventing safety problems with animal food has increased.” Referencing the Food Safety Modernization Act, which placed sweeping new authorities and requirements on both the human and animal food industries, and its resulting 21 CFR Part 507 (the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”), animal food manufacturers, including renderers, are now required to do more than ever before to identify hazards, develop risk-based preventive controls and test and monitor their safe manufacturing protocols in their animal food safety plans.

Given the breadth and depth of FSMA, the FDA stated in its letter that the CPG on Rendered Animal Feed Ingredients (CPG Sec. 675.400) and the one on Canned Pet Food (CGP 690.300) are no longer necessary:

“We have determined that the CPGs that we have withdrawn are outdated because they do not inform animal food manufacturers of the part 507 regulation, a new, integral part of the animal food safety framework. Furthermore, they are incomplete because they highlight only one type of hazard (biological) that has been associated with tissues of animal origin. … since the two withdrawn CPGs were originally released, we have issued regulations and other more extensive guidance and draft guidance that are directly relevant to animal food safety.”

In addition, on the CPG on Uncooked Meat for Animal Food (CPG Sec. 690.500), the FDA said it “simply restates the adulteration provision” of the Federal Food, Drug and Cosmetic Act’s section 402(a)(5) and its ability to “take action on uncooked animal food products derived from ‘diseased animals or animals that died otherwise by slaughter’.”

The FDA reiterated that the use of rendered ingredients in many pet foods, including canned pet food, can provide a safe source of fat and protein. The American Feed Industry Association agrees that the rendering process is sophisticated and regulated to ensure that only quality animal food products are ever used, in accordance with all state and federal laws and regulations, and is one way the industry can be more sustainable.

The FDA’s actions today should not impact animal food manufacturers’ ability to produce safe feed and pet food for animals. The FDA still maintains the same authority it has had to take action against animal food products or manufacturers that could pose a threat to human or animal health.

What does this mean for you?

  • If you are an animal food manufacturing facility that uses rendered ingredients from dead or downer animals, you must ensure that any hazards these ingredients could pose are accounted for in your hazard analysis and animal food safety plans as part of 21 CFR Part 507.
  • If you do not use rendered ingredients from these animal sources, it is still a good policy to know your suppliers and validate your supply stream to ensure you are properly managing hazards and accounting for them in your animal food safety plans.
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Status of FDA Inspections during partial government shutdown

I subscribe to a free publication “FSN – Food Safety News” to keep as up to date as possible with Food Safety issues, incidents and recalls. This article appeared this morning…

FDA food investigations running at less than 50 percent of normal

By Dan Flynn on January 22, 2019

The Food and Drug Administration has “more than 200 food investigators” on the job “not counting support staff and supervisors” out of about 550 total professionals “when the agency is fully operational,” according to Commissioner Scott Gottlieb.

In a “tweet” Monday, the FDA commissioner said he was responding to questions about staffing levels for FDA’s Office of Human and Animal  Food Operations. It was one of the most detailed statements about food safety staffing that Gottlieb has made since the partial government shutdown began on Dec. 22.

Click here to read the entire article…

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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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