Wednesday, May 4, 2016

Important Points in FSMA Final Rule on Sanitary Transportation of Human and Animal Food

Earlier this month, FDA issued the FSMA Final Rule on Sanitary Transportation of Human and Animal Food.  What are some interesting points you should know?

This rule defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle” and establishes requirements for sanitary transportation practices applicable to shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations.  The rule address vehicles and transportation equipment; transportation operations; training; records; and waivers.

The goal is to ensure that practices are in place that prevents food from becoming adulterated during transport from such issues as failure to control temperatures or cross contamination or cross contact (allergens) from inadequate cleaning.  

The rule makes the shipper responsible for compliance to the rule.  The shipper is defined as the one who arranges for the transportation of food by the carrier. The shipper could be the manufacturer or a freight broker. By rule, the shipper  must develop and implement procedures for required parameters such as temperature control and cleanliness of the vehicle. The shipper can transfer some of this responsibility to the ‘loader’ or the ‘carrier’ based upon contractual agreement. They must have documentation to demonstrate this.

The rule is not prescriptive in that FDA does not establish mandatory procedures; rather it allows industry to use best practices to do this. So there are no regulatory requirements for continuous temperature monitoring, or the sharing of documentation for each load, or how a truck should be cleaned. Rather, it requires the shipper determine what is best in order for that food to be transported without becoming adulterated.

While there are some exemptions from the rule for food that is transported, such as farm activities, most other transport is covered including intra-company transport and food destined for food banks.

What about food that arrives and is out of temperature?  According to the rule "An inconsequential failure by a carrier to meet the shipper's temperature control specifications will not necessarily create a per se presumption that the affected food has become adulterated. However, if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action to ensure that the food is not sold or otherwise distributed, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Failure to take such action may render the food adulterated."

For Loaders, those who put product onto the trucks, they must check the vehicle for sanitary condition and ensure proper temperature control prior to loading.

For receivers, those who unload the product, they must ensure that the product was not temperature abused and intact. 

Carriers, those transporting product, must meet conditions established by the shipper – to include having the right equipment to meet sanitary and temperature requirements. The must also provide cleaning as required.

When carriers have responsibilities put on them by the shippers, their employees must be trained about potential food safety problems and basic sanitary practices. This must be documented.

Here is a link to the final rule.

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