FDA Announces Three Waivers to Sanitary Transportation Rule
By way of background, on April 5, 2016, FDA released a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA). Click here for a complete copy of the final rule. Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for entities in the food industry. In short, the final rule establishes sanitary transportation practices for covered entities addressing: (1) vehicles and transportation equipment; (2) transportation operations; (3) training; (4) records; and (5) waivers. Companies generally must comply with the new requirements by April 2017. Small businesses have until April 2018 to comply.
Today, the FDA announced the publication of three waiversto the final Sanitary Transportation rule. The waivers are for businesses whose transportation operations are subject to separate State-Federal controls. They include:
Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products.
Food establishments authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers. (Examples include restaurants, supermarkets and home grocery delivery services.)
Businesses transporting molluscan shellfish (such as oysters, clams, mussels or scallops) that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority.
These waivers were contemplated and described in both the proposed and final rule. In FDA’s view, these waivers will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.