FSMA Sanitary Transportation Rule Finalized


The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) final rule on Sanitary Transportation of Human and Animal Food was published in the April 6, 2016, Federal Register and advances FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance date for some firms begins one year after publication of the final rule. Most renderers are likely already in compliance, according to the National Renderers Association (NRA), particularly if they are certified in the North American Rendering Industry Code of Practice administered by the Animal Protein Producers Industry (APPI). The final rule is available at www.gpo.gov/fdsys/pkg/FR-2016-04-06/pdf/2016-07330.pdf.

This rule is one of seven foundational rules proposed since January 2013 under FSMA to create a modern, risk-based framework for food safety. 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. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law. Specifically, the rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers. 

Who is Covered?
With some exceptions, the final rule applies to shippers, receivers, loaders, and carriers who transport food, including food for animals, in the United States (US) by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It also applies to persons (e.g., shippers) in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or distributed in the United States.

The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter US distribution. Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or US border.

Key Requirements
Specifically, the rule establishes requirements for the following.

Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure they do not cause the food transported to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.

Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready-to-eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact (i.e., the unintentional incorporation of a food allergen).

Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.

Records: Maintenance of records of written procedures, agreements, and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

Industry Comments Heard
NRA is pleased that the final rule was revised in several important sections in response to comments NRA submitted on behalf of renderers, and that the APPI Code of Practice was mentioned specifically by FDA as a tool for compliance. 

On page 20092 under the summary of the major provisions of the rule, FDA states: “We made several revisions to this final rule, in response to comments that we received regarding the proposed rule, to affirm that the use of current sanitary food transportation best practices as described in these comments, e.g., the ‘‘Rendering Industry Code of Practice’’ and ‘‘Model Tanker Wash Guidelines For the Fruit Juice Industry,’’ will allow industry to meet the requirements of this rule. Some of these best practices have been provided to the Agency as industry documents submitted with comments in the proposed rule, while others were described in the comments or the public meetings we held for the proposed rule.”

Below are some of the main points of the rule impacting rendering, which include many of NRA’s recommendations.

In response to comments about the proposed rule’s provision for transportation equipment used in operations involving food materials destined for animal consumption, FDA responded that “…we would not regard a transportation vehicle used to haul materials destined for rendering, e.g., viscera, offal, trimmings from slaughter operations, to be operating under insanitary conditions, given that the vehicle’s intended use is to haul materials that will undergo further processing to make them suitable for animal consumption. We also would not regard rendering materials in transport to be adulterated for the same reason. However, we note that those engaged in transport of materials destined for rendering should consider whether previous cargo that could cause the material to be unsafe due to potential chemical contamination is a relevant consideration.”

FDA also addressed the rendering industry’s comments about the proposed rule’s requirement for proper temperature control of “food” during transport to prevent the “rapid growth of undesirable microorganisms”: “We would not regard an unrefrigerated transportation vehicle used to transport bulk materials destined for rendering to be in violation of this rule because the vehicle’s intended use is to transport materials that do not require temperature control because they will undergo a subsequent heat processing treatment to destroy pathogens. We also would not regard rendering materials in transport, e.g., viscera, offal, trimmings from slaughter operations, to be adulterated for the same reason.”

FDA further commented in the final rule that they “agree that it would not be necessary to provide temperature control during the transportation of ingredients destined for rendering because these materials will eventually be treated with high heat to destroy pathogens. As we have previously stated, we have revised this final rule so that it focuses entirely on food safety issues. For this reason, control of temperature during transportation would not be required by the rule if such control is not necessary to ensure its safety, e.g., where its only purpose is to minimize decomposition of the food.”

Renderers will be required to identify the vehicle’s previous cargo from shippers supplying raw materials to a rendering operation, as stated on page 20150 of the final rule: “While we recognize that materials destined for rendering will receive a heat treatment to destroy pathogens, we are not exempting carriers from the requirement that they identify the vehicle’s previous cargo to the shipper supplying raw materials to a rendering operation because the shipper might wish to determine whether the bulk vehicles carried some previous cargoes that could contaminate the raw material in a way that would not be addressed by the heat processes of the rendering operation (e.g., heat stable chemical contaminants). We are retaining this provision to allow the shipper to obtain this information from the carrier, if the shipper deems it necessary for the purposes of ensuring that his product does not become unsafe during transportation.”

Requirements for shippers to ensure that a previous cargo does not make the food unsafe is addressed on page 20151: “…we have revised this rule at § 1.908(b)(4) to require the shipper to develop written procedures adequate to ensure that a previous cargo does not make the food unsafe. These procedures may describe actions that the shipper may take to provide this assurance (e.g., cleaning the vehicle, using a dedicated vehicle), or they can include actions that the carrier in accordance with § 1.908(e) or another party covered by this regulation may take to provide this assurance (e.g., cleaning the vehicle, providing a dedicated vehicle).”

NRA also asked FDA in its comments to the proposed rule that 21 Code of Federal Regulations Part 11 (electronic records and signatures) not be the standard required for records under this rule. FDA agreed that redesigning large numbers of existing electronic records and recordkeeping systems would create a substantial burden without measurable benefit so electronic records are exempt from the onerous requirements of part 11. FDA also made this change to the “Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals” final rule last year.

However, records do need to meet standards as stated on page 20155: “Although we are not specifying that part 11 applies, we expect parties covered by this rule to take appropriate measures to ensure that records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

Compliance Dates
Small businesses, which are businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts, would have to comply two years after the publication of the final rule, which was April 6, 2016. A business that is not small and not otherwise excluded from coverage would have to comply one year after the publication of the final rule.


June 2016 RENDER | back