According to the FDA, "We lack sufficient data to quantify the potential benefits of the proposed rule."
On February 5, 2014, the Food and Drug Administration (FDA) published a proposed rule (here) concerning the Sanitary Transportation of Human and Animal Food. The proposed rule establishes sanitary transportation practices "for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food." This proposed rule is part of the FDA's implementation of the Food Safety Modernization Act of 2011 (FSMA) and fits into the FDA's overall effort to focus on prevention of food safety problems throughout the food supply chain.
Background: The proposed rule establishes requirements for vehicles and transportation equipment; transportation operations; training; records creation, retention and production; and sets a procedure for obtaining waivers. The FDA references a "historical account" of unsanitary transportation practices and outbreaks that "resulted in concerns that food can become contaminated during transportation." The FDA recounts reports in the late 1980s of trucks carrying food fromthe Midwest to both the East and West Coasts and returning with garbage for Midwest landfills. Those reports led to the Sanitary Food Transportation Act of 1990 (1990 SFTA) and Department of Transportation (DOT) regulations to discourage "garbage backhauls." After an outbreak of salmonellosis in 1994, Congress passed the 2005 SFTA, a broader food transportation safety law extending beyond preventing food contamination from nonfood sources during transportation. In April of 2010, the FDA issued guidance (here) to provide the industry with broadly applicable recommendations for controls to prevent food safety problems during transport.
Adulteration and Prohibited Acts: The FSMA requires the FDA to establish criteria and definitions for determining when food should be considered "adulterated" under the Food Drug and Cosmetic Act (FDCA). Under the FDCA and the proposed rule, transporting food under conditions that fail to comply with sanitary food transportation regulations will render the food subject to being declared "adulterated" irrespective of whether the food, in fact, poses any risk to human health. The proposed rule references parallel provisions to proposals in the FDA's current good manufacturing practices (cGMP) regulations under 21 CFR Part 110.
The rule further makes clear that failure to comply by a shipper, a motor or rail carrier,or a receiver engaged in transportation operations is a "prohibited act" under 21 U.S.C. 331 of the FDCA which exposes violators to civil and criminal enforcement. Chapter 9, Subchapter III of the FDCA sets forth the provisions that render failure to comply a prohibited act subject to civil and criminal penalties.
Carrier: § 1.904 of the proposed rule defines "carrier" as "a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food." Under this definition the carrier is responsible for all functions even if performed by other persons, such as a driver that is either employed or contracted by a trucking firm to operate the vehicle.
Shipper: § 1.904 of the proposed rule defines the term "shipper" as a person who initiates a shipment of food by motor vehicle or rail vehicle. This definition makes clear that the shipper is expected to be knowledgeable about all factors concerning the food, e.g., its packaging and holding temperature requirements, relevant to its sanitary transport. In the FDA's view, "placing these responsibilities on a single person will help to avoid any confusion regarding who is responsible" for meeting the requirements of the rule.
Equipment Design: Proposed § 1.906(a) would require that the design of vehicles and equipment be suitable and "adequately cleanable for their intended use."
Required Procedures: §1.908(d)(6)(i) requires written procedures for cleaning, sanitizing and inspecting vehicles and § 1.910 establishes a requirement for training. Carriers would be required to provide training that "provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the carrierunder this proposed rule."
Records - Creation/Retention/Production: § 1.912(a) requires shippers to retain written records that demonstrate what procedures are in place and that document steps taken to ensure compliance. Among the records that must be retained are previous cargoes and intervening sanitary measures. Records must be retained "for a period of 12 months beyond when the shipper is subject to any requirement to provide such information."
Exporters and Foreign Transportation: The proposed rule sets forth sanitary transportation practices for shippers, carriers, and receivers who transport food that will be consumedor distributed in the United States and brings the provisions of the FDA's cGMP and the Food Code to bear on the transportation industry.
The proposed rule's compliance and recordkeeping requirements extend to a "person outside of the United States, such as an exporter, who ships food to the United States in an international freight container by oceangoing vessel or in an air freight container, and arranges for the transfer of the intact container in the United States... if that food will be consumed or distributed in the United States." When the FDA determines that shipper failed to comply with the requirements of this rule, food may be considered adulterated under the FDA and refused admission into the United States.
Additional Requirements for High-Risk Foods: FSMA further requires that the FDA designate a class of foods as high-risk for which additional record keeping requirements will be appropriate, including retaining records for a longer time period. On February 4, 2014, the FDA published notice seeking comments and scientific data concerning the Designation of High-Risk Foods for Tracing (here). The comment period ends April 7, 2014. It is not clear when the proposed rules will be issued but this is an important step in the rule making process.
Waivers and Exclusions: The FDA provides a procedure for obtaining waivers and has tentatively determined to waive the requirements for NCIMS Grade "A" Milk Safety Program. The proposed rule does not apply to those with operations with less than $500,000 in annual sales or certain classes of food, such as fully packaged shelf-stable foods, live food animals and certain raw agricultural commodities.
Effective Date: The FDA proposes that any final rule becomes effective 60 days after publication in theFederal Register. The FDA would require compliance one year thereafter, but in two years for small businesses. The comment period for the proposed rule ends May 31, 2014.
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