Latest News

FSMA Compliance Deadline for Large Companies Has Arrived

The first major compliance deadline for larger businesses (>500 employees) to comply with the Food Safety Modernization Act (FSMA) Preventive Control rules for human and animal foods has arrived.  FSMA was “a call for a new, prevention-oriented safety system.”  This new focus on prevention requires food facilities to have written food safety plans encompassing both Good Manufacturing Practices and applicable Hazard Analysis and Preventive Controls.

As of September 19, businesses involved in the production of human foods must comply with both the Hazard Analysis and Preventive Controls regulations as well as adhere to the current Good Manufacturing Practices published in 21 CFR Part 117 Subpart B.  Animal food businesses are only required to comply with current Good Manufacturing Practices described in 21 CFR Part 507 Subpart B.   This is a new era for food safety regulation and is being met with some expected angst and trepidation.  However, FDA has communicated that while the expectation is for businesses to be in compliance, the focus of FDA will continue to be on education and training to assist businesses in compliance.  Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, states, “We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.”  FDA’s goal is to continue to publish guidance documents to assist businesses understand expectations and will continue to engage industries.  A culture of food safety is being built, with emphasis on practices and procedures recognized to minimize the risk of safety issues.  However, FDA is quick to point out if safety issues are observed, they will take swift action.

Compliance with FSMA will be an evolving process.  Our Foods & Consumer Goods Practice staff at ToxStrategies is very knowledgeable regarding the requirements of FSMA and are available to provide assistance.  Ms. Jodi Miller, a Senior Scientist on our staff, is a recognized Preventive Control Qualified Individual Lead Instructor for both human and animal foods.  Ms. Miller is available to provide personalized PCQI training as well as a fundamentals of FSMA course.  If you need assistance implementing or complying with FSMA, or would like more information on FSMA training, please contact Jodi Miller, Senior Scientist at (937) 681-9476 or Candace Doepker, Ph.D., Food and Consumer Products Practice Leader at (513) 206-9929.   For additional information on FSMA compliance, click here.