September 19, 2016 marked the day when larger businesses must comply with new standards set forth by the FDA’s Food Safety Modernization Act (FSMA). The first year of compliance will affect the larger businesses, generally those with 500 or more employees.
The Sanitary Transport Rule aims to minimize food safety risks during transport and will apply to persons involved in the transportation of food by motor or rail carrier, including shippers, carriers, receivers, loaders and even brokers. Larger facilities will be required to protect against intentional adulteration intended to cause wide-scale public harm.
The rule is applicable to intrastate as well as interstate commerce and imposes vehicle and equipment standards, temperature and cross-contamination controls, and training and record-keeping requirements.
The Sanitary Transport rule does not apply to transportation operations of entities with less than $500,000 in average annual revenue, to foods that are completely enclosed by a container (unless the foods require temperature controls for safety) or to transportation involving certain animal food, food contact substances, compressed food gases, live animals and food that is trans-shipped or imported for future export.
As with all new regulations, questions remain about FDA’s expectations in the coming years, as well as how those uncertainties may impact business operations. As implementation nears, it is important to examine these challenges and understand key considerations regarding likely implementation challenges and potential enforcement risks.