FSMA Animal Feed Compliance – September 17, 2018
September 17, 2018 marks a big day for all animal feed facilities subject to the Food Safety Modernization Act. Effective this day all sites must have implemented the cGMP requirements, small sites must be in compliant with the full rule and large businesses, which were to comply last September, will now be subject to routine Preventive Control inspections.
FDA delayed the start of routine PCAF regulatory inspections of large facilities last year and has done the same with small facilities this year. This is being done to allow the industry as a whole to continue to learn about the process and alter their programs to be more in sync with regulatory requirements and best practices. FDA is also focusing this time on education of the industry.
FDA has maintained a fairly transparent communication program throughout the implementation process and another example of that can be found here, Jenny Murphy Q & A, which again details the how and why of FDA’s approach to the Animal Feed rule.
It is important to note that delay of routine inspections does not remove the facility responsibility of compliance. FDA reserves the right to perform random inspections of small facilities and, if an event occurs warranting investigation, your site will be expected to be in compliance with the rule and you can be held to the new provisions.
The next phase of industry learning will begin as FDA begins their routine inspections and we continue to see what application of the rule looks like in practice. To assist the industry in compliance, FDA has published PCAF final guidance on compliance with CGMPs and the small entity compliance guide; and draft guidance on the hazard analysis and preventive control requirements, the supply-chain program, and the use of human-food byproducts as animal food.
Have questions about what steps you need to take to become compliant? With over 25 years of food and feed manufacturing experience Ranck & Associates can help you meet regulatory requirements while ensuring continuity with your business objectives. Please contact us today to set up a review of your program.