What’s happening with FSMA? Here’s what we know. The compliance dates have not changed and thus far there has not been any word that the dates will be extended. Large firms (more than 500 employees) have about 6 months to come into compliance with the new current good manufacturing requirements. FDA’s guidance documents have yet to be released. It is expected that the documents will be completed sometime this summer. That doesn’t leave much time for the large firms to make use of the guidance information to prepare the procedures and guidelines that will meet the CGMP regulations.
Within the next year and one-half, those large firms will be required to have completed their hazard analysis, written their food safety plans and have implemented the steps to control significant hazards. The American Feed Industry Association is working with the University of Minnesota to identify known hazards in order to provide a starting point for mills to conduct their own hazard analysis. The Food Safety Preventive Controls Alliance (FSPCA) is also working on hazard analysis and has established a technical assistance network to help small to medium-sized companies with compliance questions and technical assistance.
The FSPCA is also tasked by FDA with developing the curriculum that lead trainers will use to train individuals to become Preventive Controls Qualified Individuals (PCQI). A PCQI is qualified through training or experience to conduct hazard analyses and to write the Food Safety Plan. It is expected that the training will offered starting in June, 2016.
Here are some steps you can take now to move toward compliance with FSMA.
1. Evaluate your housekeeping program. Is it working to keep your mill clean to the extent that you would be able to demonstrate to an inspector that animal food contamination will not occur as a result of poor housekeeping practices?
2. Evaluate your preventive maintenance program. Are preventive equipment and facility maintenance practices scheduled and can you show an inspector what your program includes and that the maintenance and inspection practices are being done?
3. Look at the Current Good Manufacturing Practices that your mill is currently required to follow. If your mill is licensed and registered as a medicated feed mill, there is a comprehensive set of CGMPs that you are already required to follow. If you manufacture medicated feed, but are not required to be licensed, you are required to meet a reduced set of CGMPs. The medicated feed mill requirements will still be enforced in addition to the new CGMPs required under FSMA.
4. Review the new CGMPs that will be required under FSMA. You will find that you are already complying with many of the practices, but may not have documentation to prove that you are in compliance. Procedures need to be implemented to meet the elements required within the CGMPs. This is what needs to be in place by mid September, 2016 for the large companies and by mid September, 2017 for most feed mills.
We don’t recommend heading to far beyond this point into the Hazard Analysis and Food Safety Plan part of the requirements until the guidance documents are released, hazards information is developed by the AFIA and others and the PCQI training begins.
OSH Solutions is here to help guide you through the process. Please let us know if you have any questions or would like assistance with any part of the steps listed above.
