Food Safety Modernization Law

The Food Safety Modernization Act signed into law January 2011 may finally get some teeth in 2015 and 2016 as we hit the deadlines for the FDA to publish new rules. Rules for preventative controls for both human and animal food are due August 30th, while produce safety regulations are due October 31st. Food transportation is scheduled for next March.

It is probably too early to accurately predict exactly what these rulings will include, but better process documentation, better labeling, and better temperature control records are a safe bet. Regulations are bound to be heavily influenced by existing legislation from around the world, existing rules for the transport of prescription drugs are a likely place to start.

Health Canada Guidelines for Temperature Control of Drug Products during Storage and Transportation call for continuous temperature monitoring of storage refrigerators and freezers with alerts when temperatures are out of spec. They also call for temperature data logging in transit to assess the impact of any so called “temperature excursions”; records must remain available for review for 1 year.

WHO Good Distribution Practice  calls for regularly calibrated sensors to monitor goods during storage and transit, as well as retention of data for 1 year beyond the shelf life of the goods.

Irish Medicines Board Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances is an exhaustive document that puts particular emphasis on temperature monitoring. Annually calibrated, high accuracy (+/- 0.5C) devices should monitor goods in storage and transit, be reviewed monthly, and reporting protocols should be in place for any deviations.