FDA Final Rule on the Sanitary Transportation of Food Compliance Gains Momentum

On June 6, 2016, the FDA's final rule on the sanitary transportation of food came into effect. While larger carriers, shippers, and receivers are expected to have their compliance plans ready, smaller businesses (those with fewer than 500 employees and less than $27.5 million in annual revenue) have an additional two years from the rule's publication date to comply with the regulations.

This rule, the sixth of seven rulemakings under the Food Safety Modernization Act (FSMA), was developed based on the Sanitary Transportation of Food Act of 2005 and feedback from over 240 submissions by transportation companies, food safety organizations, consumer advocacy groups, and others.

The aim of this rulemaking is to ensure:

1. Proper refrigeration during the transportation of perishable goods,
2. Adequate cleanliness and sanitization of vehicles and storage areas,
3. Sufficient protection for food during transit.

There are proposed waivers for carriers, shippers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade 'A' Milk Safety Program. These exemptions apply when they're transporting Grade A milk and milk products. Retail and food service operations with valid permits are also exempt when they handle transportation as receivers, or as shippers and carriers where food is directly given to consumers after transport.

Foods covered under this ruling include all FDA-regulated human and animal food, with some exceptions such as compressed food gases, live animals, transportation performed by farms, and food fully enclosed in packaging that doesn't require Temperature Control for Safety (TCS).

While the FDA hasn't provided exact figures or projections regarding the impact of this rule on food safety, they estimate the first-year cost to be around $162.7 million, with an annual ongoing cost of approximately $93.5 million.

Key Requirements Under This Rule

Vehicle and Equipment Cleanliness

All vehicles and equipment used in food transport (excluding exempt items) must be designed and made of materials that can be thoroughly cleaned. This includes bins, bulk containers, pallets, pumps, loading systems, totes, and other transport equipment.

Transportation Practices

Ensuring safe food transport involves assigning responsibility to supervisors or management teams. Key responsibilities for shippers, receivers, and carriers include:

Shippers: Must provide written instructions to carriers regarding safe transport conditions, such as cleaning protocols and temperature control. Shippers are also responsible for inspecting vehicles and equipment to confirm proper cleaning and sanitation. Additionally, they must verify that pre-cooling has occurred when necessary.

Shippers and Receivers: Must offer convenient handwashing facilities for carrier employees when food isn't entirely contained in sealed packaging. Both parties are also responsible for safely loading and unloading food products.

Carriers: Must transport food using sanitary methods. They should pre-cool refrigerated units as requested by shippers and demonstrate compliance with temperature requirements when prompted.

Information Sharing

Clear communication channels must be established between shippers, carriers, and receivers. Disclosing previous cargo details and cleaning practices is critical to preventing contamination. For instance, sharing information about potential allergen cross-contact between previous and upcoming loads helps maintain food safety.

Training

Carriers must undergo training if they agree to take responsibility for transportation operations. Although the FDA doesn't specify the duration or content of the training, the focus is on raising awareness about food safety procedures rather than teaching specific tasks.

Record Keeping

Both shippers and carriers are required to maintain records. Shippers need to keep documents proving they've communicated safe transport instructions to carriers for at least 12 months, though these records can be stored offsite. Carriers must retain agreements with shippers regarding safe transport information for 12 months post-agreement and also document employee training related to food transport, keeping these records for 12 months after the individual stops performing those duties.

This rule is expected to impact approximately 83,609 businesses. While its precise effects on food safety remain uncertain, the FDA aims to enhance safety during food transport by regulating temperature control, cleaning standards, and protection during transit.