FSMA Rule Seven: Sanitary Transportation of Human and Animal Food

Inside FDA's February 27 public meeting for FSMA rule number seven: Sanitary Transportation of Human and Animal Food. FDA

On January 31 the United States Food and Drug Administration (FDA) proposed the seventh and final rule to be made under The Food Safety Modernization Act (FSMA).

Rule Number Seven: Sanitary Transportation of Human and Animal Food

Transportation practices resulting in food adulteration has been a concern for the United States leading to several Congress enacted laws over the past few decades.

The newest weapon to combat this issue is the Sanitary Transportation of Human and Animal Food Rule which will require shippers, carriers and receivers who transport human and animal food either by motor or rail vehicles to follow appropriate sanitary transportation practices.

By establishing criteria to properly protect food from adulteration FDA hopes to ensure transportation practices minimize and prevent food safety risks.

“This proposed rule will help reduce the likelihood of conditions during transportation that can lead to human or animal illness or injury,” said FDA deputy commissioner for food and veterinary medicine Michael R. Taylor. “We are now one step closer to fully implementing the comprehensive regulatory framework for prevention that will strengthen the FDA’s inspection and compliance tools, modernize oversight of the nation’s food safety system, and prevent foodborne illnesses before they happen.”

Proposed Rule Requirements

Vehicle Cleanliness, Equipment Cleanliness and Transportation Operations: This rule includes requirements for shippers, transporters and employees responsible for the transit of food to follow specific guidelines to prevent food adulteration including:

  • Ensuring vehicle cleanliness prior to loading food not completely enclosed by its container such as fresh produce boxes and crates.
  • Diligently monitor vehicle temperature to avoid temperature danger zones for products such as meat, poultry and seafood as well as prevent microbial spoilage for products such as pasteurized juice.
  • Shippers verify transportation vehicle is at proper temperature prior to food products being loaded for shipment.
  • Upon request transporters demonstrate to shippers and receivers proper temperature control was utilized during transit.
  • Transporters will be required to provide shippers and receivers detailed information about previously transported products and sanitization steps to clean the vehicles in between jobs.
  • Transporters will be required to develop and implement written procedures to provide aforementioned information to shippers and receivers. They are also required to provide information of their practices in regard to cleaning, sanitizing and inspecting vehicles and transportation equipment.

Transportation companies required to follow this rule are allowed to continue the use of their current best practices procedures including cleaning, inspection, maintenance, loading and unloading of product and operation of vehicles and equipment to prevent adulteration of food.

Records: Records are to be kept by both shipper and transporter:

  • Shippers will be required to specify to transporters, in writing, proper sanitary requirements for both the vehicle and equipment used during transport as well as temperature requirements food must be kept under to avoid adulteration. Shippers will also be required to maintain their own records showing this information was supplied to transporters.
  • Transporter’s cleaning, sanitizing and inspection processes are subject to record keeping.

Training: Specific requirements will be established for transporters to follow to properly train food handling employees and maintain records the training was completed.

Waivers: If a particular handling practice is determined to not create adulterated products FDA will have specific procedures to follow when allowing and/or revoking a waiver.

Costs, Compliance and Exclusions

Cost: FDA estimates 83,609 firms within food transportation and food facilities including United States Department of Agriculture (USDA) will be covered by the newly proposed rule. FDA estimates a cumulative first year cost to be $149.1 million and total annual costs at approximately $30.08 million.

Compliance: After publication of the final rule FDA feels one year for businesses other than small business and two years for small business to be enough time to become compliant under the new rule.

Exclusions: New rule requirements exclude transportation services grossing $500,000 or less in annual sales as well as transportation of fully packaged shelf-stable foods, live food animals, and raw agricultural commodities when transported by farms.

Important Information

FDA held a public meeting for this proposal February 27 at the Hilton Chicago in Chicago and two more are scheduled: March 13 at the Sheraton Park Hotel in Anaheim and March 20 at FDA Center for Food Safety and Applied Nutrition in College Park, Maryland. 

Public comment deadline is currently set for May 31.

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