Final GFI#245 Hazard Analysis and Risk Based Preventive Controls for Food for Animals – this presentation will review the major changes from the draft version as they relate to a multi-species feed mill. How does this final version impact your Feed Safety Plan.
New Draft GFI #272 – Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover – what does it say and how does this impact the implementation of 21 CFR Part 225? How does this help in writing your Feed Safety Plan?
General Q&A on FSMA.
Presentation Topics & Individual Sessions begin at 11:00 am
12:00 to 1:00 Lunch will be provided
What Are Mycotoxins – Richie Shepardson from NutriQuest
A review of Mycotoxins: what they are and where they come from. This will give us the basis to discuss mycotoxins and how we can monitor control and manage them in the mill and on the farm.
Testing for Mycotoxins – Mark Enninga from Envirologics
We will learn a little about real-time testing capabilities at the mill and discuss strategies that can fit into cGMPs and Food Safety Plans
Variability in Feedstuffs – Cliff Ocker from Rock River Lab
An in depth look at ingredient variability and a discussion on what that means for formulation and mixing at the mill.
2022 Crop Toxin Loads – Katelynn Robbins from Biomin
An initial look at the 2022 crop toxin loads and we will send you home with a sample kit for you own corn to help us build up the 2022 database.
Feed Quality summary/discussion and a tour of CFD – Dr. Eric Reid
Individual Sessions with Barbara Simeon to review Feed Safety Plans, FDA inspection results and discuss individual questions on FSMA.
Cost: $100 (session fee above waived)
Times: One hour on a First Come First Serve basis with priority on time selection given to those attending in person.
Pre-Requisite: Provide an electronic copy of your Feed Safety Plan and/or Inspection Results no later than December 1, 2022 to [email protected]. Also include any specific questions you might have so that I can research the information.
(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.
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 following information was provided by AFIA on 3/13/19. Used with permission…
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
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).
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
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.
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.
The following is the bottom line on methods for reporting combustible dust… It is an excerpt from a longer article published AFIA on 1/15/19 and is used with permission…
“EPA and industry agree on the following approach for combustible dust reporting:
The EPA agrees that there are two simple, reasonable options to complete the Tier II form for combustible dust, which ensures emergency planners have the relevant information they need about potential combustible concerns at a feed or grain operation. Depending on the nature or size of your feed or grain operation:
Reporting Option #1 – If combustible dust is likely present at any level below the 10,000-pound threshold. If a facility has a reasonable basis to conclude that it has some volume of combustible dust, but it is below the 10,000-pound threshold, then a facility should:
(1) check the “combustible dust” box in the “physical hazards” column; and (2) check the “below reporting thresholds” box in the last column (the “additional reporting information” column) of the Tier II form.
Reporting option #1 is likely most appropriate for most facilities. EPA has concluded that there is no obligation for a facility to provide any further information if the “below reporting thresholds” is checked.
Reporting Option #2 – If combustible dust is likely above the 10,000-pound threshold If a facility has a reasonable basis to estimate that it may have combustible dust above the 10,000 -pound threshold, then it should:
(1) check the box in the “physical hazards” column; and (2) complete the “inventory” column using an estimation method or calculations based on the facility’s best professional judgment.
This option may be more applicable for those facilities that collect and store combustible dust in a bin or container.
Reminder: Certain local or state jurisdictions may require additional reporting
While the EPA agrees with industry on the two options for reporting above, facilities may be subject to additional local or state Tier II reporting requirements for combustible dust. You may need to check your county or state requirements to determine whether this may be the case and complete your Tier II report accordingly.”