This guidance is intended for persons engaged in food transport, including persons who transport food (and store it during transport) as well as manufacturers or other persons who arrange for the transportation of food. The term “food” means articles used for food or drink for man or other animals, and components of any such article. (21 U.C.S. 231(f)).
We are issuing this guidance to provide all sectors of the food industry with broadly applicable recommendations for controls to prevent food safety problems during transport while we are implementing the Sanitary Food Transportation Act of 2005 (2005 SFTA; Pub. L. No. 109-59, 119 Stat. 1911). When those regulations are finalized, FDA will reassess the need for this guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
In 2005, Congress passed the 2005 SFTA, which in part created section 416 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350e). Section 416 of the act requires FDA to promulgate regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in food transport to ensure that food is not transported under conditions that may render the food adulterated. As part of our implementation of the 2005 SFTA, FDA issued an Advance Notice of Proposed Rulemaking in 2010 (the 2010 ANPRM) (Federal Register of April 30, 2010; 75 FR 22713) to obtain data and information from the public about certain food transportation issues. As discussed in the 2010 ANPRM, over the past few decades there have been several incidents in which food was contaminated during transport, or which demonstrated the potential for food to become contaminated during transportation.
Over the years, FDA has addressed the transportation of food in several regulations and guidance documents (see Appendix). However, each of these regulations and guidance documents is limited in scope – e.g., to a particular circumstance (such as decontamination of food transport vehicles that have been flooded or otherwise impacted by hurricanes, before being placed back in service to transport or store food (Ref. 1)) or to a particular segment of the food supply (such as fresh produce (Refs. 2 and 3)). This guidance differs from the prior regulations and guidance in that it provides all sectors of the food industry with broadly applicable recommendations.
In the 2010 ANPRM, we described a 2009 report developed by Eastern Research Group, Inc. (ERG), under contract to us, regarding the findings of a study designed to characterize current baseline practices in the sectors involved in food transportation and to identify current areas where food is at risk for adulteration (Ref. 4; the ERG report). The ERG report describes the results of a comprehensive literature review pertaining to food handling practices in the food transportation industry. The ERG report also presents the findings from an expert opinion elicitation study, which ERG conducted to identify the main problems that pose microbiological, chemical, and/or physical safety hazards to food during transportation and storage, and to determine the preventive controls needed to address each of the problems identified. The findings of the expert panel, as presented in the ERG report, are broadly consistent with agency policies, and we have incorporated many of their findings into our recommendations.
In our effort to assist the food transport industry in preventing food safety problems during transport while we are implementing the 2005 SFTA, we want them to be aware of the following problem areas where food may be at risk for physical, chemical, or biological contamination during food transport:
- Improper refrigeration or temperature control of food products (temperature abuse).
- Improper management of transportation units (or storage facilities used during transport) to preclude cross-contamination, including improper sanitation, backhauling hazardous materials, not maintaining tanker wash records, improper disposal of wastewater, and aluminum phosphide fumigation methods in railcar transit;
- Improper packing of transportation units (or storage facilities used during transport), including incorrect use of packing materials and poor pallet quality;
- Improper loading practices, conditions, or equipment, including improper sanitation of loading equipment, not using dedicated units where appropriate, inappropriate loading patterns, and transporting mixed loads that increase the risk for cross-contamination;
- Improper unloading practices, conditions, or equipment, including improper sanitation of equipment and leaving raw materials on loading docks after hours;
- Poor pest control in transportation units (or storage facilities used during transport);
- Lack of driver/employee training and/or supervisor/manager/owner knowledge of food safety and/or security;
- Poor transportation unit design and construction;
- Inadequate preventive maintenance for transportation units (or storage facilities used during transport), resulting in roof leaks, gaps in doors, and dripping condensation or ice accumulations;
- Poor employee hygiene;
- Inadequate policies for the safe and/or secure transport (or storage during transport) of foods, e.g., lack of or improper use of security seals;
- Improper handling and tracking of rejected loads and salvaged, reworked, and returned products or products destined for disposal; and
- Improper holding practices for food products awaiting shipment or inspection, including unattended product, delayed holding of product, shipping of product while in quarantine, and poor rotation and throughput.
To address some of the problems enumerated above, we recommend that persons engaged in food transport concentrate their efforts at this time on the following, broadly applicable preventive controls:
- Appropriate temperature control during transport;
- Sanitation, including:
- Monitoring and ensuring the sanitation and condition of transportation vehicles as appropriate;
- Pest control; and
- Sanitation associated with loading/unloading procedures;
- Appropriate packaging/packing of food products and transportation units (e.g., good quality pallets, correct use of packing materials);
- Good communications between shipper, transporter and receiver; and
- Employee awareness and training.
The following references are on display in Docket No. FDA-2010-N-0013 in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.