More updates…

Inspection Statistics:

This summer AFIA published the following statistics on inspections completed in FY2019 (October 2018 – September 2019):

 FY 2019 CGMP*FY 2020 Plan CGMPFY 2019 HA/PC*FY2020 Plan HA/PC
Domestic Inspections964
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 2019FY 2020 Plan
Sanitary Transportation9584
FSVP2875
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.

Training Opportunities:

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
  • cough
  • sore throat
  • runny or stuffy nose
  • muscle or body aches
  • headaches
  • fatigue (tiredness)
  • 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. 

To learn more about how and where to get a flu shot, contact your employer or visit: https://www.cdc.gov/flu/.

Flyer for the Workplace (PDF: 2.19MB)

“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 (barbsimeon@co-opfeed.com)

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 barbsimeon@co-opfeed.com and I will refer to the appropriate Elanco rep to help you out…

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.

Update from AFIA on FSMA Inspections

The following information was provided by AFIA on 3/13/19. Used with permission…

The Food and Drug Administration had a busy year in 2018 conducting inspections for the current good manufacturing practice (CGMP) and the hazard analysis and risk-based preventive controls portions of the Food Safety Modernization Act (FSMA) regulations. In this update, the American Feed Industry Association shares the latest data received through a Freedom of Information Act request.

Current Good Manufacturing Practice Inspections

In 2018, the data indicates that state and/or federal inspectors performed and/or completed 622 CGMP inspections in 47 different states, one U.S. territory (Puerto Rico) and four countries (Canada, Mexico, India and Indonesia). 

The majority of CGMP inspections (58 percent) occurred at feed manufacturers or integrated feed facilities. Ingredient suppliers, renderers, distributors and facilities classified as “other” also received inspections during the same time frame. 

Across the 622 inspections, 28 facilities received a FDA Form 483 (“Notice of Inspectional Observations”). Of the 28 forms issued, 14 were Voluntary Action Indicated (VAI, or minor issues), five were classified as No Action Indicated (NAI) and eight were not classified. One facility failed inspection, receiving an Official Action Indicated (OAI) notice. Issues related to pest control and housekeeping were mentioned on most of the FDA Form 483s, with the most common examples being spilled feed, bird droppings and nests, live and dead rodents, cat excrement and the presence of roaches. Although a facility may consider many of these observations irrelevant, the FDA considers them serious. There are no sanitation standards that specify the number of rodents or droppings that can be present at a feed facility, but AFIA cautions that numerous dead rodents or other sanitary issues may draw FDA’s ire. General sanitation standards apply to animal food establishments under the FSMA CGMPs

Hazard Analysis and Risk-Based Preventive Controls Inspections

Inspections for large-sized animal food facilities (i.e., those firms with more than 500 full-time equivalent employees) on the hazard analysis and risk-based preventive controls regulations began in late 2018. These large-sized firms have been required to be in compliance with the regulations since September 2017, however, the FDA delayed inspections while it trained investigators, allowing firms more time to gather documentation under the system. 

Through the FOIA request, AFIA has learned of seven hazard analysis and risk-based preventive controls inspections that occurred in 2018. The inspections were held in four states at feed manufacturing, integrated feed facilities and pet food facilities. From the seven inspections, six facilities received a FDA Form 483, which is a very high rate. It is believed this high rate of observations can be attributed to the fact that the FDA purposefully sought out these facilities as they may have had recent animal food safety incidents. As industry interprets receiving a FDA Form 483 as very serious, AFIA is in communication with FDA officials regarding this action to help ensure the reasons the agency issued a FDA Form 483 are truly adverse findings versus a simple method of documenting the findings from the inspection.   

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…