FSMA Update
Are Your Actions Lined Up With Your Words?
If an important customer stopped into your facility today and asked to see your Food Safety Plan on a scale of 1 to 10 with one being a full blown panic attack and ten being a state of bliss what would be your number? How about if we substituted FDA inspector for important customer? Would that change your number?
Most of the readers of this update have completed their initial Hazard Analysis as required under FDA FSMA. The Hazard Analysis makes up a substantial part of your firm’s food safety plan, especially when you have determined that there are no hazards that require a preventive control.
Here’s an important question. How confident are you that the procedures you have claimed to be following are in fact in place and are being consistently followed. As an example, feed mills will often state in their hazard analysis that they use incoming ingredient receiving inspections to minimize the hazards of foreign materials. If a customer or inspector stood at your receiving pit while a load of corn was being dumped are you sure that they would observe your employee follow the steps that are outlined in an operating procedure or that at least follows standard industry practices?
We recommend that your PCQI (Preventive Controls Qualified Individual) and other supervisory personnel reinforce the importance of the animal food safety procedures with employees through observation and training.
Housekeeping and Pest Control
Updates from the American Feed Industry Association (AFIA) and recent inspection experiences continue to note that the most common deficiencies observed during inspections involve pest control issues and housekeeping shortcomings. Control of birds is presenting a challenge for many mills. Bird nesting and the amount of bird feces observed around exposed feed and other potential contamination are key indicators of an issue. Keep doors, windows and other wall openings closed when feasible. Work with your pest control company or contact a firm that specializes in bird control.
You should have a housekeeping program in place. An effective program includes a list of priority areas, a schedule and what cleaning methods are to be used. There should be a sign off indicating who did the work and a system of follow up inspections to verify that the program is working. Plant cleanliness is the easiest CGMP to evaluate for both you, your customer and an inspector.
Mycotoxin Testing
Mycotoxins are a class of chemical hazard common in the feed and grain industry. When this hazard is identified within a firm’s hazard analysis, it is expected that mycotoxin testing will be conducted as appropriate. The Preventive Controls Qualified Individual for Animal Food training manual notes that “Any raw materials susceptible to natural toxins, most commonly mycotoxins, must be evaluated
and used in such a way that both human and animal health is protected.” Here is a link to the publically-available manual. The regulation referenced for that statement is 21 CFR 507.25(b)(2) which addresses Plant Operations and raw material receiving practices.
The weather experienced in many parts of the country this past season created conditions where the mycotoxin DON (deoxynivalenol) otherwise known as vomitoxin infected grains, especially corn, wheat, and barley. Here is a link to the 2018 Neogen Capstone report for your reference. Neogen provides a weekly update on conditions as the harvest season progresses and is one resource that can be used to monitor what is happening with mycotoxins.
A mycotoxin risk management plan is a vital part of your food safety program. The FDA or State Inspector will inquire about your program and how you evaluate mycotoxins. On site testing is the most effective and practical approach. On site testing provides real time results and enables immediate action regarding load refusals or other decisions relating to the disposition of the contaminated ingredient.
Other evaluation approaches include requiring testing and certification from the supplier. One type of product and supplier where this may be feasible is in your purchasing of distillers from an ethanol plant. You can also send samples to a lab for testing. The turnaround time for the testing is such that you wouldn’t be able to hold the ingredient until your results came back.
The question that you must be able to answer is “What are you doing to ensure that your feed products are not contaminated with unsafe levels of mycotoxins.?”
Employee Training
When is the last time you discussed food safety issues with employees? The regulations state that employees must be trained in animal food safety practices and hygiene issues. There is no requirement for refresher training. With that limited requirement in mind, please be sure to check and see if you have hired new employees since you conducted your initial training sessions. This training should be part of your new employee orientation process.
There is an observation among emergency responders that “people rise to the level of their training”. The movies might show the hero figuring things out on the fly, but in real life most people are as capable as their training and education. An ongoing promotion and education in the realm of food safety will help employees to continue to do what you want them to do and will enable them to confidently answer questions that might be thrown at them during the course of an inspection.
