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FDA Submits Final FSMA Food Rules

On August 31, 2015, the US Food and Drug Administration (FDA) reported that the Food Safety and Modernization Act (FSMA) final preventive control rules for both human and animal food had been submitted to the Federal Register for publication. The final rules were required by the federal district court in Oakland to be submitted by August 30, 2015 based on a 2014 settlement with the Center for Food Safety and the Center for Environmental Health. The documents submitted to the Federal Register can be published several days after submission, with larger files requiring more time to be processed and displayed for public access.

FSMA is the most significant addition to the US food safety laws since the establishment of the Federal Food, Drug, and Cosmetic Act in 1938, over 70 years ago. President Obama signed FSMA into law on January 4, 2011.   At the time of adoption, FDA Commissioner Hamburg stated 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. It also allows FDA to focus on foods and food facilities that represent the highest risk to public health.   The final rules will be enforceable beginning in August 2016 for the majority of the human and animal food industries. There will be a delayed implementation timeline for companies meeting the small business definition that will be outlined in the final rules.

Our Foods Practice staff at ToxStrategies has been active in the commenting process for the proposed rules and will closely review the final rules as soon as they become available. Periodic updates will be posted on our website as we learn more about changes included within the final rules. If you have specific questions regarding FSMA, 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, click here.