Compliance Date Approaching for FSMA Preventive Controls Rules
September 18, 2017 marks the next compliance date under the Preventive Controls for Human and Animal Food Rules of the 2011 Food Safety Modernization Act (FSMA). The U.S. Food and Drug Administration (FDA) will require larger animal food businesses and smaller human food businesses with fewer than 500 full-time employees to begin complying with preventive controls requirements that include the development and implementation of written Food Safety Plans. Small animal food businesses with fewer than 500 full-time employees must implement Current Good Manufacturing Practices (CGMP) established by the animal food rule and will be expected to comply with remaining preventive controls requirements next year on September 17, 2018.
Compliance with preventive controls and CGMPs may involve considerable time and effort to achieve. While FDA has stated that it does not plan to conduct routine inspections on these specific areas immediately, the agency has suggested that it may react in response to a food safety issue or complaint. In order to ensure your facility is prepared for compliance at all times, Registrar Corp provides important information regarding what will be expected of covered food facilities this September.
What does compliance look like?
For larger animal food and smaller human food businesses:
Food businesses complying with preventive controls will be required to develop and implement written Food Safety Plans that feature an analysis of known or reasonably foreseeable food hazards as well as the measures required to prevent or minimize their threat to public health. Within this plan, covered food facilities should document appropriate monitoring and verification of their specified preventive controls. Examples include appropriate controls for Salmonella, appropriate controls for potential mycotoxins and for nutrient deficiencies or toxicities, and evidence that scientifically validates proposed preventive measures.
As part of this plan, FDA requires any covered food facility that identifies hazards needing preventive controls to develop a written recall plan. The plan should establish detailed procedures that outline how the buyer of the food and the public will be notified of the recall and hazard in question. It should also outline the steps that will be taken to verify that the recall is being enacted and the method that will be used to properly dispose of the recalled food.
Food Safety Plans can be complicated, and FDA requires a “Preventive Control Qualified Individual,” defined by FDA as an individual with appropriate training or job experience to effectively carry out the requirements under these regulations, to develop them. Registrar Corp’s Regulatory Specialists possess the requisite qualifications to develop a Food Safety Plan for your facility.
For smaller animal food businesses:
Animal food facilities within this category will be required to implement and maintain CGMP standards outlined by FDA. These standards focus upon fundamental food safety practices in regard to the manufacture of animal food. Facilities will be required to ensure that daily operations limit possible food contamination from a variety of factors.
Staff in direct contact with food or food-contact surfaces should follow hygienic practices such as consistently washing hands and removing jewelry that could fall into batches of food. Facility grounds should be properly maintained and free from litter and waste to exclude pests. Additionally, the construction and layout of facilities should allow for proper cleaning, maintenance, and pest control, while taking measures to prevent potential contamination of food from factors such as condensation dripping off of pipes or fumes that need proper ventilation.
Not sure if your facility is properly following CGMP requirements? Registrar Corp’s Food Safety Specialists can perform a Mock FDA inspection that identifies potential food safety violations and educates facility staff on FDA expectations. Mock Inspections are included in Registrar Corp’s U.S. Agent service at no charge, aside from travel and lodging costs.
Registrar Corp assists companies with FDA compliance. Our Regulatory Specialists are knowledgeable and experienced in the various aspects of FSMA and can help your food facility take the necessary steps to meet FDA’s extensive food safety requirements. For more information, please call +1-757-224-0177. Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.