In my last post I talked about two different inspections. I hope these “tales” encouraged you (neither was as “bad” as the mills expected); I hope these “tales” inspired you (to be “ready” for your inspection). Are you ready? What have you done? Over the next few months, I will recap the requirements of the FSMA rule. I hope I can encourage and inspire you to get ready for your inspection. Instead of me telling you what you need to do, I want you to tell me what you have done…
The original CFD FSMA project helped you to “say what you do”, by writing Standard Operating Procedures, the focus was on Current Good Manufacturing Practice. In my training classes I highlighted some of the best practices I have seen various mills do to comply with CGMP’s. Over the past few years, I am confident you have come up with some great ideas.
Every two weeks, I will post the text of one CGMP. I hope you will use each 2-week period to focus on your compliance with this part of the rule. Read it and think about your compliance. What have you done, what do you need to do better than briefly share one or two ideas of ways you comply with this CGMP. Here is the schedule:
I will summarize responses (anomalously of course) in an update to each post.
2/21 507.14 Personnel
3/07 507.17 Plant and Grounds
3/21 507.19 Sanitation
4/04 – Happy Easter!
4/11 507.20 Water Supply and Plumbing
4/25 507.22 Equipment and Utensils
5/09 507.25 Plant Operations
5/23 507.27 Holding and Distribution
507.14 Personnel – Management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices as necessary to protect against the contamination of animal food (21 CFR 507.14(a)).
Persons working in direct contact with animal food may include employees, contractors, and visitors. Methods for conforming to hygienic practices and maintaining cleanliness include: maintaining adequate personal cleanliness; washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination; removing or securing jewelry and other objects that could fall into animal food, equipment, or containers; storing clothing and personal belongings in areas other than where animal food is exposed or where equipment or utensils are cleaned; and taking any other precautions necessary to protect against contamination of animal food, animal food contact surfaces, or animal food-packaging materials (21 CFR 507.14(b)).
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.
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.
This summer AFIA published the following statistics on inspections completed in FY2019 (October 2018 – September 2019):
FY 2019 CGMP*
FY 2020 Plan CGMP
FY 2019 HA/PC*
FY2020 Plan HA/PC
964 311 FDA 676 State
589 180 FDA 409 State
221 178 FDA 56 State
455 360 FDA 95 State
# of Violations (Form 483)
85 75 VAI* 9 OAI*
44 28 VAI 16 OAI
* Current Good Manufacturing Practice * VAI (Voluntary Action Required) * OAI (Official Action Required) * HA/PC (Hazard Analysis and Preventive Controls
FY 2020 Plan
Expect that inspections will be stacked meaning they will combine CGMP and HA/PC with FSVP, Sanitary Transportation of Food, Medicated Feed CGMP, BSE and VFD inspections as applicable to the facility. The more types of inspections your facility is subject to may increase the likelihood of inspection.
With most of our member feed mills being on NY and PA, it is worth noting that NY Department of Agriculture did not contract with the FDA to perform inspections, but PA Department of Agriculture did contract to do both CGMP and HA/PC. In my opinion, PA members may expect inspections sooner if they have not already been visited but it may take some time for NY to see significant inspections…
Then Came COVID-19:
As we all know by late March of 2020 everything changed as COVID-19 forced the world to “pause”. Our industry is of course essential and had to do its part to keep moving as if the world was “normal”. The FDA briefly halted inspections other than for cause indicating immediate threat to health and safety. Inspections resumed on a very limited basis in July 2020. All inspections are being scheduled so precautions can be taken during the visits. Some work is being done virtually to limit direct contact.
What is next???
Next month, I will attend a virtual conference of FSPCA Lead Instructors for FDA recognized courses in CGMP’s, HA/PC and FSVP. We expect presentations from many sources including the FDA. As with everything else the focus will be on the impact of COVID-19. I will certainly share what I learn. If you have any questions regarding the impact of the virus on your operations, please reach out to me, so I can try to get answers. There will be a breakout session specifically for Animal Food. There will also be a presentation to provide us as lead instructors more information on opportunities for virtual training as the pandemic plays out in the next year.
Winter 2021 may be an opportunity to provide a virtual (or very small in person) Part B of the Blended Hazard Analysis and Preventive Controls for Animal Food. If you, or any of your Feed Safety Team, needs this training, please let me know. If you have taken Part A, you normally must complete Part B within 6 months. This window has been extended due to lack of course availability.
New tools have been released:
In October FSPCA released an “Abbreviated Guide to Creating a Livestock Food Safety Plan Under the Preventive Controls for Animal Food (PCAF) Rule”. I am in the process of reviewing this guidance and the included example feed safety plan. More information will be forthcoming.
Finally, some reminders from the FDA…
Facility Registration Deadline is December 31, 2020
Have questions on Facility Registration? See my post on November 8th for an FDA FAQ document to get answers…
Getting a flu shot is more important this season than ever before!
November 18, 2020
The FDA wants to remind the millions of men and women on the front lines of growing, processing, preparing, selling and delivering food for both people and animals, to get their seasonal flu shot.
The Centers for Disease Control and Prevention and the healthcare community are preparing for flu viruses and the virus that causes COVID-19 that will spread this fall and winter. Both are contagious respiratory illnesses, but they are caused by different viruses. One of the most important differences is that there is a vaccine already available that can protect you against the flu. While getting a flu shot will not protect against COVID-19, a flu shot will protect you by reducing your risk of flu illness, hospitalization, and possibly death. Protecting yourself from the flu will also help save medical resources for the care of COVID-19 patients. People who have flu often feel some, or all, of these symptoms:
fever or feeling feverish/chills
runny or stuffy nose
muscle or body aches
some people may have vomiting and diarrhea, though this is more common in children than adults.
The best time to get a flu shot is now before the flu begins spreading in your community. It takes about two weeks after getting a vaccine for antibodies to develop in the body and provide protection.
The same factors that contribute to workplace and community spread of COVID-19– including prolonged close contact with coworkers, congregate housing, shared transportation, and frequent community contact among workers—likely contribute to the spread of the flu.
When an essential worker gets a flu shot, they protect themselves, their families, co-workers, and their communities. Healthy workers help to ensure the availability of a safe and nutritious food supply.
The FDA has published these FAQ’s . Please read if you have any questions on registration. This process is also used to make required attestations for small facilities claiming to be “exempt” from FSMA otherwise known as a qualified facility.
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…
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 AMhere to help – Barbara Simeon (email@example.com)
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.
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 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 firstname.lastname@example.org and I will refer to the appropriate Elanco rep to help you out…