As of June 6, 2016, the FDA's final rule on the sanitary transportation of food officially came into play. Larger carriers, shippers, and receivers were expected to have their compliance plans ready, while smaller companies—those with fewer than 500 employees and less than $27.5 million in annual revenue—were given an extra two years from the rule's publication date to comply with the new requirements.
This final 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 around 240 submissions by transportation companies, food safety organizations, and consumer advocacy groups. The aim of this regulation is to ensure proper refrigeration during food transport, maintain cleanliness and sanitation of vehicles and storage areas, and protect food during transit.
There are some 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 would apply specifically when they're transporting Grade A milk and milk products. Retail and food service operations holding valid permits would also be exempt when engaged in transportation activities as receivers or shippers and carriers in cases where food is handed directly to consumers after being transported from the establishment.
The rule applies to all FDA-regulated human food and animal (including pet) food, with certain exceptions like compressed food gases, live animals, transportation performed by farms, and food in fully enclosed and non-Temperature Control for Safety (TCS) packaging. Although the FDA hasn't provided exact figures on how this rule will impact food safety, they estimate the initial cost for the first year to be $162.7 million, with an annual recurring cost of approximately $93.5 million.
**Key Requirements Under the Rule**
**Vehicles and Transportation Equipment:** All vehicles and equipment used in food transport (excluding exemptions) must be designed and constructed to allow for thorough cleaning. This includes bins, bulk containers, pallets, pumps, loading systems, totes, and other similar items.
**Transportation Operations:** Responsibility for ensuring safe food transport falls on designated supervisors or management teams. Specific duties include maintaining temperature control, segregation of products, and basic hygiene practices such as handwashing.
For **shippers**, they must outline the necessary conditions for safe food transport in writing, including cleaning protocols and temperature controls, and confirm the vehicle and equipment have been appropriately cleaned and sanitized. Pre-cooling of refrigerated units is also a responsibility before transport begins.
**Receivers** and **shippers** must provide hygienic loading and unloading points for carrier staff when food isn't fully contained. **Carriers** must ensure the transportation method itself is sanitary, pre-cool refrigerated units as directed by shippers, and prove compliance with temperature standards upon request.
**Information Exchange:** Clear communication channels must be established among shippers, carriers, and receivers. Details regarding previous cargo and cleaning actions are crucial for preventing contamination. Sharing this information can help avoid cross-contact and cross-contamination risks.
**Training:** Carriers are required to undergo training if they agree to take responsibility for transportation operations. While the FDA doesn't specify the duration or exact topics for the training, its primary goal is to increase awareness of food safety practices.
**Record Keeping:** Both shippers and carriers must keep detailed records. Shippers need to retain evidence of providing safe transport instructions to carriers for at least a year, which can be stored off-site. Carriers must document agreements with shippers concerning safe transport information for one year post-agreement and maintain records of employee training for 12 months after the individual stops handling food transport.
The FDA expects this rule to impact roughly 83,609 businesses. While the exact effects on food safety remain uncertain, the administration aims to enhance food safety during transportation by regulating temperature control, vehicle cleanliness, and the overall protection of food throughout the transport process.
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