On April 6, 2016, the Food and Drug Administration (FDA) published the final rule for the sanitary transportation of human and animal food.  The rule aims to prevent food contamination during transportation by requiring covered entities involved in transporting human and animal food to follow recognized best practices for sanitary transportation.  The rule seeks to prevent unsanitary practices such as the failure to properly refrigerate food, the inadequate cleaning of vehicles between loads, and the failure to properly protect food. 

The rule implements the Sanitary Food Transportation Act of 2005 (SFTA) as well as the requirement in section 111 of the Food Safety Modernization Act (FSMA). The rule is the sixth rule of seven major rules to be finalized that implement the core principles of FSMA to strengthen the food safety system and protect public health.  The final rule builds on the Preventive Controls for Human Food and Animal Food rules, the Produce Safety rule, Foreign Supplier Verification program rule and the Accreditation of Third-Party Certification rule, all of which FDA finalized last year. The seventh rule, which focuses on mitigation strategies to protect food against intentional adulteration, is expected to be finalized later this year.

Covered Entities  

The regulation will apply to food transported within the United States by motor or rail vehicle, regardless of whether the food is offered for or enters interstate commerce. Shippers, loaders, carriers, and receivers engaged in transportation operations of food imported by motor or rail vehicle and consumed or distributed in the United States are also subject to the final rule.  The rule also applies to  persons, e.g., shippers, in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.  The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution.  Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.

Key Provisions

The rule establishes the following key provisions:

  • Vehicles and transportation equipment must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food. Ultimately, the rule seeks to regulate the design and maintenance of these vehicles and equipment to make sure that they do not cause the transported food to become unsafe.
  • Measures must be taken during transportation of food to ensure food safety. Specifically there must be adequate temperature controls, prevention of the contamination of ready to eat food through the contact with raw food, protection of food from non-food item contamination by non-food items in the same or previous load, and protection of food from cross-contact with allergens.
  • Records of written procedures, agreements, and training (required of carriers) must be maintained. The time period to retain these records depends on the type of record and when the covered activity occurred, but would not exceed 12 months.
  • Training is required for carrier personnel in sanitary transportation practices and the training must be documented. The training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.

Waivers

The agency intends to publish waivers 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. This waiver applies only when Grade A milk and milk products—those produced under certain sanitary conditions—are being transported.
  • Food establishments holding valid permits issued by a relevant regulatory authority, such as a state or tribal agency, when engaged as receivers, or as shippers and carriers in operations in which food is relinquished to customers after being transported from the establishment. Examples of such establishments include restaurants, supermarkets, and home grocery delivery operations. FDA acknowledges that controls for such transportation operations already exist under the Retail Food Program, with state, territorial, tribal and local enforcement and FDA oversight.

The FDA also received comments asking for a waiver for transportation operations for molluscan shellfish for entities that hold valid state permits under the National Shellfish Sanitation Program. The agency continues to review comments on this request, and will issue a determination in the near future.

Exemptions

The following activities are exempt from the final rule:

  • Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue;
  • Transportation activities performed by a farm;
  • Transportation of food that is transshipped through the United States to another country;
  • Transportation of food that is imported for future export and that is neither consumed or distributed in the United States;
  • Transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances;
  • Transportation of human food byproducts transported for use as animal food without further processing;
  • Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety; and
  • Transportation of live food animals, except molluscan shellfish.

The FDA will provide opportunities to help the industry understand and comply with the final rule. The FDA will issue guidance to assist industry in complying with the final rule. The FDA FSMA Food Safety Technical Assistance Network is already available as a central source of information to assist industry with the implementation of FSMA.  Also, on April 25, 2016, the FDA will host a webinar about the finalized rule.

Businesses would be required to comply with the new regulation by April 06, 2017, which gives these businesses one year after publication of the final rule to meet the requirements. Smaller businesses[1] have two years to comply with the new requirements.  Given the one-year timeframe to enactment, companies should evaluate whether they are exempt from these new requirements or whether they hold valid permits that would enable them to apply for a waiver.  Companies should inspect their transport vehicles to see whether they currently comport to FDA’s requirements.  Unless they are exempt from the requirements of this rule, companies should begin to implement compliance policies, standard operating procedures, and training programs for personnel, in order to ensure that they will be in compliance with FDA’s newly-issued requirements when the deadline hits one year from now.  Of course, companies must also be mindful of the other FSMA final rules and deadlines; the first FSMA implementation deadline is on the horizon as the compliance dates for the requirements of the Preventive Controls for Human Food rule begin this September for some companies. Furthermore, the compliance dates start in January 2017 for some farms under the Produce Safety rule and  in late May 2017 for some companies under the Foreign Supplier Verification program rule.  Companies have some time before the Accreditation of Third-Party Certification rule is implemented, as the FDA does not intend to implement the third-party auditor program until after publication of the Model Accreditation Standards final guidance and the final rule user fee rule, both of which are yet to be published.  Keep checking The Health Law Pulse for updates regarding the Accreditation of Third-Party Certification rule and compliance dates.

[1] Small businesses are defined as those businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts.