A new rule issued by the FDA, which will require those transporting human and animal food to follow best practices in sanitary transportation, is the sixth of the seven Proposed rules under the Food Safety and Modernization Act (FSMA) (P.L. 111-353) to be finalized. This action by the FDA was first proposed in February of 2014 and is part of a “larger effort to focus on prevention of food safety problems throughout the food chain.” The seventh Final rule under the FSMA is expected to be issued later this year (Final rule, 81 FR 20092, April 6, 2016).
Purpose and background. Both FSMA and the Sanitary Food Transportation Act of 2005 (SFTA) required the FDA to issue regulations to dictate that shippers, carriers by motor vehicle or rail vehicle, receivers, and others involved in the transportation of food to use sanitary practices to guard against conditions that would result in adulterated food. In February of 2014, the FDA released a Proposed rule to this aim, which included a description of practices focused on food refrigeration, cleaning of transport vehicles, and the proper protection of food during transport. It also was created in order to focus on scenarios in which there is the greatest risk of contamination during transport (see FDA proposes requirements to ensure food safety during transport, February 5, 2014; Proposed rule, 79 FR 7006, February 5, 2014).
Summary. The Final rule covers the sanitary transportation of food by establishing criteria that must be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others involved in the transportation of food. The FDA defined transportation in this rule as “any movement of food in commerce by motor vehicle or rail vehicle.” The rule established requirements for the identified entities in the following areas: (1) vehicle and transportation equipment; (2) transportation operations; (3) training; (4) records; and (5) waivers. In general, the rule was built on the existing best practices in the industry and is meant to allow a certain degree of flexibility in its implementation, so as to allow the industry to continue using such best practices.
Proposed rule modifications. Due to feedback received during the comment period after the issuance of the Proposed rule on this subject, the FDA revised some portions of the Proposed rule. These modifications include the:
- simplification of definitions of parties covered by the rule;
- amendment of the definition of “transportation operations;”
- replacement of language indicating that the purpose of the rule was both food safety and additional non-safety concerns including spoilage and quality defects;
- removal of prescriptive requirements for temperature monitoring devices and continuous temperature monitoring and replacement of those requirements with a more flexible approach;
- addition of a requirement that states if a person becomes aware of potential unsafe practices, the person must take an appropriate course of action;
- revision of requirements that make clear that the account of the type of vehicle used in transport is relevant to the applicable sanitary provisions; and
- revision of provisions to clarify that the determinations of the appropriate transportation operations is the responsibility of the shipper.
Seven rules. The issuance of this rule marks the finalization of the sixth Final rule out of a total of seven that were proposed under FSMA. To date, besides this Final rule, the FDA has finalized guidelines for preventive controls for human food and animal feed, produce safety, foreign suppliers, and the accreditation for third-party certification parties (see Top five ‘food fights’ in 2015, December 18, 2015; Final rule, 80 FR 55908, September 17, 2015; Final rule, 80 FR 56170, September 17, 2015; Final rule, 80 FR 74354, November 27, 2015; Final rule, 80 FR 74226, November 27, 2015; Final rule, 80 FR 74570, November 27, 2015). The seventh Final rule, which will issue regulations that focus on mitigation strategies to reduce the intentional adulteration of food, is schedule to be published later in 2016. According to the FDA, the seven rules under FSMA “will work together to strengthen the food safety system and better protect public health.”
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