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.

The FSMA rule on Sanitary Transportation of Human and Animal Food is part of the FDA’s effort to protect foods from farm to table by keeping them safe from contamination during transportation. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food.

These waivers are being published after being described in the proposed and final rule. FDA considered comments on the waivers and found that the waivers would not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.

More information regarding the Sanitary Transportation rule (including a discussion of the comments we received on these waivers), and any of the FSMA provisions, is available at FDA.gov.

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