Animal Feed Safety Information
Information and resources related to the Food Safety Modernization Act (FSMA)
The following update was received this week from AFIA regarding FSMA inspections. While it is difficult to get an exact count, it appears about two dozen inspections have occurred in CFD member states as of December 22, 2017. We can expect this to increase in 2018.
Continue reading “AFIA Update as CGMP Inspections Continue for Large and Small-sized Firms”
American Feed Industry Association (AFIA) is very active in FSMA education and outreach. They continually survey members to learn more about ongoing FSMA inspections. CFD’s membership in AFIA affords us the opportunity to share their findings. The following are excerpts of information they recently shared. I hope you find it helpful as you prepare for your facility inspection.
Continue reading “AFIA Shares what its members have learned from CGMP Inspections…”
Today is the day we have all been working towards.
Continue reading “Small Business FSMA Compliance date has arrived”
It has been my opinion that inspections of small businesses (less than 500 employees) would not be likely in the near term. After all FDA has their hands full with large businesses and state cooperative agreements are not yet in place. Today, AFIA sent an update and they said…
Continue reading “Inspections expected to begin next month for small businesses”
FDA Released a Food Safety Plan Builder Tool – DO NOT USE THIS!
In August of 2016 the FDA released Draft Guidance for Industry Current Good Manufacturing Practice. I have written previously that AFIA submitted 13 pages of comments on the 36 page document and that I was reluctant to discuss this draft document because of some of the things it contains. It is a year later and the compliance deadline is upon us (September 2017) but the guidance is still in draft form! It does not look like anything will change so it is time to move on…
Continue reading “FDA Draft Guidance for Industry Current Good Manufacturing Practice”
I am a lead instructor for this course (Certificate#2ca42a12). Below are chapter summaries from this very important training. This training is recognized by the FDA as one way to become a Preventive Controls Qualified Individual (PCQI). As an instructor I feel it is an excellent way to become fully versed in the rule and obtain training necessary t implement the rule. I encourage owners, operators, agents in charge of a facility and the person to be designated as the facility PCQI to attend this training.
This class is highly interactive and each chapter has exercises and in some cases small group activities. You will not complete a FSP for your facility during this class but you will gain the knowledge on how to do so when you return to your facility.
Regulatory Overview and Introduction to the Rule – This chapter goes over Sub Parts A, D and F in detail. It addresses important definitions and roles, the training requirements of the rule, exemptions and records requirements.
Current Good Manufacturing Practice – This chapter defines the purpose and importance of cGMP’s. It explains the basic requirements of the 8 cGMP’s, which are the baseline standards required to manufacture safe feed. They provide the foundation on which you will write you Food Safety Plan (FSP).
Animal Food Safety Hazards are described in this chapter. The hazard analysis process is described defined what to consider in this process, how to identify hazards by species and a general awareness of the biological, chemical (including radiological) and physical hazards in animal food.
Food Safety Plan is defined in terms of required and optional elements. Example FSP’s are included in the curriculum. re described in this chapter.
Hazard Analysis, and Preventative Controls Determination – in this chapter you will learn how to conduct a facility specific hazard analysis including how to the access the severity and probability of a hazard and to determine if a hazard requires a Preventive Control.
Required Preventive Control Management Components – this chapter describes the steps you must take to manage the Preventive Control if you have one.
Defines in great detail Process Controls, Sanitation Controls and the Supply Chain Applied Control.
Recall Plans – defined with examples.
There are many organizations offering PCQI training throughout the country and this will grow over time. If you are considering attending training, make sure it is for the Animal Food Industry and that it is certified by FSPCA. Not all training is certified.
As of July 2017, we are starting to see opportunities to take this training virtually via your computer. I have taught a class virtually and I do not recommend it for the following reasons:
Unless you have extensive HACCP background or a third party certification at your facility I do not recommend this method of delivery.
The sub parts of this rule that you need to comply with are based on the activities you perform in your business:
| Sub Part | Title | Manufacture / Process / Pack | Hold | BY |
| A | General Provisions (training) | YES | YES | 9/17/17 |
| B | Current Good Manufacturing Practice | YES | YES | 9/17/17 |
| C | Hazard Analysis and Risk- Based Preventive Controls | YES | NO | 9/17/18 |
| D | Withdrawal of a Qualified Facility Exemption | NA | NA | NA |
| E | Supply Chain Program | YES | NO | 9/17/18 |
| F | Records (as they apply to above) | YES | YES | As above |
In order to gain compliance with FSMA you should consider writing standard operating procedures (SOP’s) that demonstrate or document your compliance with cGMP’s.