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FDA Releases Final Rule on Sanitary Transportation

Apr 06, 2016

The Food and Drug Administration submitted the final rule on the sanitary transportation of human and animal food to the Federal Register last week, and it was published today. The rule maintains several points that the dairy industry supported in the proposed rule and provides clarification on key points that IDFA and the National Milk Producers Federation requested in their joint comments filed in 2014.

The rule, required by the Food Safety Modernization Act, will regulate the transportation of human and animal food products to protect them from food-safety hazards during transport. It is intended to eliminate food safety risks, like improper refrigeration of food, inadequate cleaning of vehicles between loads and failure to properly protect food during transportation.

Points that were clarified or changed;

  • FDA has replaced the prescriptive temperature monitoring and recording devices with a more flexible approach;
  • The rule no longer applies to human food completely enclosed by a container (unless temperature control is necessary to preserve food safety) or human food byproducts that will be used in animal feed; and
  • FDA plans for the rule to include a wavier for shippers, carriers and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety program. The waiver only applies when the transporter is engaged in transportation operations involving Grade “A” milk and milk products.

IDFA is currently reviewing the final rule and will provide a more detailed summary in the coming weeks.  

Tiered Compliance Dates

Recognizing that small businesses may need more time to comply with the requirements, FDA has proposed tiered compliance dates based on company size. Small businesses must comply by April 6, 2018, and all other businesses will have to comply by April 6, 2017.

FDA will hold a webinar April 25 at 11 a.m. Eastern to review the rule.

IDFA also is scheduling a webinar on the rule with speakers from FDA and Hogan Lovells US LLP, IDFA’s outside legal counsel and FSMA experts. The presenters will focus on the applicability of the Sanitary Transport rule to dairy companies and explain the waiver for PMO milk and milk products. IDFA will announce a date and details for that webinar soon. 

For more information, contact Emily Lyons, IDFA director of regulatory affairs and counsel, at elyons@idfa.org or John Allan, IDFA vice president of regulatory affairs and international standards, at jallan@idfa.org.

 
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