On April 5, the U.S. Food and Drug Administration (FDA) published the Sanitary Transportation of Human and Animal Food final rule
under the U.S. Food Safety Modernization Act (FSMA). The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. This final rule will affect many businesses in the produce supply chain including shippers, carriers and receivers.
Additionally covered by this rule are 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.
Specifically, the rule establishes the following requirements:
- sanitary design and use of motor and rail vehicles implemented to protect food during transportation,
- operational controls that must be used during transportation, such as adequate temperature controls and preventing contamination of ready to eat food from touching raw food,
- training of carrier personnel, and
- recordkeeping to demonstrate compliance with the rule.
It’s important to note this rule does not cover on-farm transportation. FDA is considering development of guidance for on-farm transportation and, of course, on-farm activities are covered under the Produce Rule.
To help industry members prepare, PMA in collaboration with the United Fresh Produce Association and other leading produce trade organizations have joined to provide a free webinar briefing by FDA on May 11
covering this new rule. This webinar will help produce industry members understand what businesses are covered by this new rule, what new regulatory obligations are and the implications for businesses along the supply chain.
FSMA implementation concerns
As we shift to the education and compliance phase of FSMA
implementation, PMA’s is continuing to work to advance produce safety in ways that are practical for members to implement. Of concern to the produce industry right now are differing standards faced by packinghouses depending upon whether they are located on-farm (Produce Safety Rule) or off-farm (Preventive Controls for Human Foods Rule). Despite the looming Sept. 19 compliance date with the Preventive Controls for Human Foods Rule, many produce businesses operating packinghouses remain uncertain which rule they are obliged to follow.
PMA and other leading produce associations and stakeholders have repeatedly requested that FDA not create a split regulatory system, whereby packinghouses performing exactly the same activities would be subject to different food safety requirements based simply on where a packinghouse is physically located. PMA is working to once again underscore the importance of this issue by requesting a meeting with FDA to discuss potential solutions and to urge the agency to provide produce industry members with the following:
- expedited issuance of draft guidance regarding which rule will apply to specific packinghouse-business situations and how off-farm packing facilities subject to the Preventive Controls for Human Foods Rule may comply by following the requirements of the Produce Safety Rule,
- development of produce packinghouse-specific compliance training for firms subject to the Preventive Controls for Human Foods Rule, and
- expedited release of the Produce Safety Alliance training curriculum.
FDA has acknowledged the unintended consequences faced by off-farm produce packinghouses. The agency has also publically stated it will issue guidance clarifying how off-farm produce packinghouses can comply under the Produce Safety Rule. Nonetheless, no such guidance has been issued, and produce businesses operating off-farm packinghouses remain in limbo.