WASHINGTON, April 5, 2016 - Vehicle design and maintenance, temperature controls, training, and recordkeeping are key aspects of a new rule from the Food and Drug Administration addressing food transportation.

“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,” FDA said in announcing the new regulations, required by the Food Safety Modernization Act of 2011.

George Kimbrell, a senior attorney with the Center for Food Safety, which forced FDA through litigation to issue its FSMA rules by specific dates, was pleased that FDA met the latest deadline. Kimbrell said CFS would be “carefully analyzing” the regulations to determine whether they are, in the group’s view, in compliance with FSMA. 

Some firms will have to comply with parts of the new rule within a year; others will have more time. For instance, small businesses will get two years after publication to comply with training requirements for carriers, while all other businesses will have one year.

One major change from the proposed to the final rule is the removal by FDA of “prescriptive requirements for temperature monitoring devices and continuous monitoring of temperature during transport.” The agency decided instead to adopt “a more flexible approach that allows the shipper and carrier to agree to a temperature monitoring mechanism for shipments of food that require temperature control for safety.”

“We agree with the comments that ask us to clarify that a deviation from the shipper’s temperature specifications does not necessarily and automatically cause the food to be unsafe, and, therefore, adulterated,” FDA said in the rule, which is due for publication in the April 6 Federal Register.

An “inconsequential failure by a carrier to meet the shipper’s temperature control specifications” does not necessarily mean that the food has become adulterated, FDA said. However, any person subject to the regulations who “becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation . . . 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.”

FDA also removed a provision from its proposal that would have required the carrier to demonstrate temperature control to the receiver for every shipment that requires it. Instead, the carrier would only have to do that “if the shipper or receiver requests it, which is consistent with industry best practices and would likely only be done in situations in which it is suspected that there has been a material failure of temperature control.”

The agency rejected suggestions that it exempt food transportation within the same company from the rule’s requirements. “The fact that shippers, loaders, carriers, and/or receivers may be operating within a unified corporate/legal entity or sanitary food transportation system does not necessarily ensure that all of the involved parties are operating in compliance,” FDA said in the rule.

The rule stuck with proposed language to exclude the transport of live animals from the definition of “transportation operations” and thus, from the rule’s requirements.

In comments on the proposal, CFS had said that the stress of transportation, including variations in temperature, “is linked to the presence of foodborne illness pathogens. Stressed animals are more likely to shed pathogens in large numbers, and studies show that long-distance transport may increase fecal shedding of disease agents.”

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FDA recognized that the stress of transportation “may increase the shedding of pathogenic bacteria in the manure of animals,” but said it was unaware of scientific information establishing that “this leads directly to an increased level of pathogenic bacteria in food products originating from animals coming from FSIS-inspected slaughter facilities that could be controlled by establishing requirements through this rulemaking.”

CFS argued, however, that the Food Safety and Inspection Service “does not adequately address” risks from transport of live animals. “Even if FSIS could address the risks, FDA cannot pass its statutory duty to regulate sanitary transportation onto FSIS to regulate at a later stage in the food system.”

FDA also revised the final rule “to provide that all transportation activities performed by a farm are not subject to this rule.” At the same time, the agency agreed with commenters that “issuing a guidance document on farm transportation operations may be useful in setting forth good transportation practices, given the diverse practices that occur within this sector.”

FDA plans to publish waivers from the rule for the following:

  • “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 only applies when Grade A milk and milk products—those produced under certain sanitary conditions—are being transported. FDA acknowledges that controls for such transportation operations already exist under the NCIMS program, with state enforcement and FDA oversight.
  • “Food establishments holding valid permits issued by a relevant regulatory authority, such as a state or tribal agency, when engaged as receivers, 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.


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