Regulatory Developments

FDA Announces Three Waivers To Sanitary Transportation Rule

April 7, 2017

On April 6, 2017, the U.S. Food and Drug Administration (FDA) published three waivers to the now final Sanitary Transportation rule mandated by the FDA Food Safety Modernization Act (FSMA) for businesses whose transportation operations are subject to separate state-federal controls in the Federal Register. 82 Fed. Reg. 16733. The waivers 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 (e.g., restaurants, supermarkets, and home grocery delivery services); and
     
  • 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.

FDA reviewed comments on the waivers after they were included in the proposed rule 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. The waivers became effective on April 6, 2017.


 
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