FDA Proposed Rule on the Sanitary Transportation of Human and Animal Food
Executive Summary: The Food and Drug Administration (FDA) is proposing to establish requirements for shippers, carriers by motor vehicles and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This applies to both interstate and intrastate commerce. This rule making is part of a larger effort to focus on prevention of food safety problems throughout the food chain and is part of the Agency's implementation of the Sanitary Food Transportation Act of 2005 and the FDA Food Safety Modernization Act of 2011 (FSMA).
Isolated incidents of insanitary transportation practices for human and animal food, outbreaks and illnesses caused by contamination of these foods during transport have resulted in concerns over the past decades about the potential that food can become contaminated during transportation. The goal of the proposed rule is to ensure that transportation practices do not create food safety risks. Practices that create such risk include failure to properly refrigerate food; inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation.
The proposed rule builds upon current safe food transport practices and is focused on ensuring that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices. It otherwise would allow the transportation industry to continue to use best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operations of vehicles and transportation equipment, that it has developed to ensure that food is transported under conditions and controls necessary to prevent contamination and other safety hazards.
The proposed rule would not cover shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. In addition, the requirements in the proposed rule would not apply to the transportation of fully packaged shelf-stable foods, live foods, animals, and raw agricultural commodities (RACs) when farms transport RACs.
Cost and Benefits: FDA estimates that the proposed rule would cover 83,609 firms and a total first year cost of $149.1 million (with an average of $1,784 per firm) and total annual cost is estimated to be $30.08 million (with an average of $360 per firm). FDA cites that they lack sufficient data to quantify potential benefits; nevertheless, improving food transportation systems could reduce the number of recalls, reduce the risks of adverse health effects related to such contaminated human and animal food and feed, and reduce the losses of contaminated human, animal, and feed ingredients and products.
Overall Provisions of the Proposed Rule:
- FDA seeks comments on “other” entities engaged in the transportation of food whose function in food transportation would be expected to affect the sanitary condition of food, and as such should be subject to the requirements of this rule.
- FDA tentatively concludes that the provisions in the proposed rule should be applicable to activities that are intrastate in character.
- This proposed rule sets forth sanitary transportation practices for shippers, carriers, and receivers who transport food that will be consumed or distributed in the United States.
- Additionally, this proposed rule would apply “in addition” not replace other FDA regulations that are applicable to food transportation. Including, cleaning of equipment requirements for current manufacturing practices (CGMP) for medicated animal feeds and addressing substances prohibited from use in animal food and feed.
Definitions: “Shipper” is defined to mean a person who initiates a shipment of food by motor vehicle or rail vehicle. This does not include licensed property brokers, per discussion with FDA staff.
Summary of the Major Provisions of the Proposed Rule: The proposed rule would define transportation as any movement of food in commerce by motor vehicle or rail vehicle. The proposed rule would also establish requirements for sanitary transportation practices applicable to shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations.
Specifically, the proposed rule would establish requirements for:
- Vehicles and transportation equipment;
- Transportation operations;
- Records; and
Vehicle and Transportation Equipment Requirements (Proposed Section 1906):
- 1. Requires that the design of the vehicles and transportation equipment used in transportation operations, the materials used in their manufacture and their workmanship to be suitable and that they are adequately cleanable for their intended use to prevent the food that they transport from becoming filthy, putrid, decomposed, or otherwise unfit for food.
- 2. Requires that vehicles and equipment be maintained in such a sanitary condition as to prevent food that they transport from becoming filthy, putrid, decomposed, or otherwise unfit for food.
- 3. Requires that vehicles and equipment used in transportation operations that can support the rapid growth of undesirable microorganisms, be so designed, maintained, and equipped to be able to maintain the food under temperature conditions that will prevent it from supporting such microbial growth.
- 4. Requires that each freezer and mechanically refrigerated cold storage compartment in vehicles or equipment for food that can support the rapid growth of undesirable microorganisms, be equipped with an indicating thermometer, temperature-measuring device, or temperature-recording device to show the temperature accurately within the compartment.
- 5. Requires that vehicles and equipment are stored in such a manner as to prevent the harboring of pest or becoming contaminated in any other way.
- 6. Recommends that cleaned and sanitized portable equipment with food-contact surfaces and utensils be stored in a location and manner that protects food-contact surfaces from contamination.
Transportation Operations (Proposed Section 1908):
- Shippers (Section 1908(b):
- 1. Requirements apply to all shippers, carriers, and receivers engaged in transportation operations unless specifically stated otherwise.
- 2. Requires that responsibility for ensuring that transportation operations are carried out in compliance with all requirements as proposed be assigned to competent supervisory personnel.
- Require that all transportation operations be conducted in a manner and under such conditions as are necessary to ensure food does not become filthy, putrid, decomposed, or otherwise unfit for food.
- Would require that persons take effective measures such as segregation or isolation to protect food from contamination during transportation operations of raw foods and non-food items in the same load.
- Would require that persons take effective measures such as segregation, isolation, or other protective measures such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations.
- Would require persons to ensure that food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation is transported in a manner, including temperature conditions to ensure the food does not become contaminated.
- 5. Requires that before loading food not completely enclosed by a container onto a vehicle or into transportation equipment, the shipper must visually inspect the vehicle or the transportation equipment provided by the carrier for cleanliness and determine the vehicle is in appropriate sanitary condition for the transport of food.
- 6. Requires that a shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, specify in writing to the carrier, (except a carrier who transports the food in a thermally insulated tank) the temperature condition necessary during the transportation operation, including the pre-cooling phase, to ensure that the operation will maintain the temperature conditions.
- 7. Requires that a shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, verify that each freezer and mechanically refrigerated cold storage compartment or container has been pre-cooled in accordance with the information submitted by the shipper as required.
- 8. Requires the shipper to assume the requirements of providing demonstration to the receiver, if the shipper and carrier have agreed in writing, that the shipper is responsible for ensuring that the food was held under acceptable temperature conditions during transportation operations.
- Shippers and Receivers (Section 1098(c)):
- 1. Require that shippers and receivers provide vehicle operators who are expected to handle food not completely enclosed by a container during loading and unloading operations with access to a hand washing facility that is convenient and that provides running water.
- 2. Require shippers and receivers of food carry out loading and unloading operations under conditions that will prevent the food from supporting such microbial growth.
- Carriers (Section 1908(d):
- 1. Require carriers to supply a vehicle and transportation equipment that meets any requirements specified by the shipper in accordance with proposed rule and is otherwise appropriate to prevent food from becoming filthy, putrid, decomposed, or otherwise unfit for food.
- 2. Require carriers to establish requirements relevant to the maintenance of temperature control of foods.
- Require carrier to demonstrate to shipper and receiver (if requested) after the transportation move, to show that the carrier maintained temperature conditions consistent with those specified by the shipper. Unless the carrier and shipper have agreed in writing that, the “shipper” is responsible for monitoring the temperature conditions.
- 3. Require that before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for the transportation of food, a carrier must pre-cool each mechanically refrigerated freezer and cold storage compartment as specified by the shipper.
- 4. Require carrier that offers a bulk vehicle for food transportation to provide information to the shipper that identifies the three previous cargoes transported in the vehicle.
- 5. Require carrier that offers a bulk vehicle for food transportation to provide information to the shipper that describes the most recent cleaning of the bulk vehicle.
- 6. Require carriers to develop and implement specified written procedures subject to the records requirements.
- Require written procedures to specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in transportation of food.
- Require written procedures that describe how the carrier will comply with the provisions for temperature control.
- Require written procedures that describe how the carrier will comply with the provisions for the use of bulk vehicles as discussed earlier.
- Training (Section 1910):
- 1. Establish training requirements for carriers.
- Require carriers to provide training to personnel engaged in transportation operations 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 carrier under this proposed rule. This training would be required upon hiring and as needed thereafter.
- Require carriers to establish and maintain records that document required training of personnel. Such records would be required to include the date of the training, the type of training, and the person(s) trained.
- Records (Section 1912):
- Establish requirements for the retention and availability of records applicable to shippers and carriers engaged in transportation operations.
- Require shippers to retain records that demonstrate that they provide information as required in Section 1908 for a period of 12-months beyond when the shipper is subject to any requirement to provide such information.
- Require carriers to retain records of any written agreements and written procedures required by Section 1908 that describe cleaning, sanitizing, and inspection procedures for vehicles and transportation equipment for a 12-month period beyond when such agreements and procedures are in use in their transportation operations.
- Require carriers to maintain training records for a 12-month period beyond when the person identified in any such records continue to perform duties for which the training was provided.
- Require shippers and carriers make all records required by this proposed rule available to a duly authorized individual promptly upon oral or written request.
- Require all records by this proposed rule be kept as original records, true copies (photocopies, etc.), or electronic records.
- Provide that except for written procedures required by 1908(d)(6) (carriers procedures dealing with cleaning, sanitizing, temperature control, use of bulk vehicles), offsite storage of records is permitted after 6-months following the date the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review.
- Provide that all records subject to this proposed rule are subject to the disclosure requirements under part 20 (CFR part 20 Freedom of Information Act).
- Waivers Sections 1914-1934):
- Provides FDA the authority to waive a requirement with respect to any class of persons, vehicles, food, or nonfood products, if FDA determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and the waiver will not be contrary to the public interest.
- Provide that FDA will consider whether to waive a requirement on FDA’s own initiative or on the petition submitted.
- Provide that a petition requesting a waiver must describe the persons, vehicles, food, or nonfood products to which the waiver would apply.
- Establishes presumption that the information submitted in a petition requesting a waiver and comments submitted on such a petition does not contain information exempt from public disclosure under FOIA and would be made public as part of the docket associated with this request.
- Establish the Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM), of the Director of the Office of Compliance, CFSAN, or the Director of the Office of Surveillance and Compliance, CVGM, as the responsible official for responding to a request for a waiver from one or more requirements.
- Establish the general procedures applying to a petition requesting a waiver from one or more requirements.
- Provide that FDA, on its own initiative, determine that a waiver is appropriate; FDA will publish in the Federal Register a notice setting forth the waiver and the reasons for such waiver.
- Would specify that a waiver granted by FDA becomes effective on the date that notice of the waiver is published in the Federal Register.
- FDA would be able to modify or revoke a waiver if they determine that the waiver could result in transportation of food under conditions that would be unsafe.
- Establish procedures that apply if FDA determines a waiver should be modified or revoked.
- Potential Waivers
- Shippers and carriers who hold valid permits and are inspected under the National Conference on Interstate Mike Shipments (NCIMS) Grade “A” Milk Safety Program, only when engaged in transportation operations involving Grade A milk and milk products.
- Food establishments holding valid permits, only when engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.
Effective Date: The regulation would become effective one year after the date of publication of the final rule for all covered parties except for small businesses, which would be given two years to come into compliance.