New FDA Regulations for Sanitary Food Transport Take Affect This Week

by anthonylewis213

Will a shift in procedures and burden-of-proof change your plans for 2015 and beyond?

FDA_FSMA_act1The Food Safety Modernization Act (FSMA) is the first significant overhaul in 70 years took effect August 30th. It governs preventive controls for human and animal food and affects the way food is transported.

The rule would affect shippers, carriers and receivers alike. It was proposed “as a part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005,”*. It is designed as a preventative tool rather than a reactionary one.

Why is the change needed?

While Salmonella, Escherichia coli and Listeria outbreaks continue to have negative effects on public health and put consumers on edge, the technology and political climate have changed since these regulations were first introduced. Live product and shipment tracking, the Internet, foreign suppliers, food packaging and processing have all made significantly since the 1940s and so should regulations.

The CDC documents trends in foodborne illness caused by bacteria—which illnesses are decreasing and which are increasing with the goal of reducing foodborne illness. While only tracking about 15% of the US population, they still estimate that Foodborn specific illnesses amount to about 48 million people falling ill, including 128,000 hospitalizations and 3,000 deaths (Source CDC).

While such existing rules as The Carmack Amendment and HACCP procedures attempt to address these outbreaks, it is important to understand how the new rules will further affect your processes and even shift the liability from shipper to carrier.

How does this affect your business?

As a shipper, carrier, freight intermediary, or receiver, you should already be compliant with previous regulations and guidelines as part of your company’s standard operating procedures. However, it is important to understand the effect of the new regulations on your policies, contracts and general business practices as these can have a on both your brand and your legal stance.

What do you need to provide?

As a shipper As a carrier
Shippers must specify to carriers, in writing, what are the carrier’s vehicle and equipment sanitary requirements. This includes

  • Design requirements
  • Cleaning procedures
  • Temperature control requirements
  • Inspection, verification, and record-keeping requirements
  • Show shippers & receivers they have maintained temperature controls
  • Provide info about previous cargo hauled in bulk & how vehicles were cleaned
  • Personnel required to develop, implement  & document procedures describing how they will comply with these requirements
  • Personnel required to also train in sanitary transportation practices & document their training

Much of what is listed here should be pretty standard, not contracting with FDA-compliant carriers will be essential to satisfying customer requirements and minimizing exposure to liability. Those not in compliance with these rules will be considered “adulterated” and open to risk or litigation.

A shifting burden of proof

The Carmack Amendment established a uniform, national liability system for interstate carriers and allows a carrier to require all claims for loss or damage by a shipper be made in writing within nine months from the date of the loss. It also allows a carrier to limit its liability if all prerequisites have been met.

Unlike the Carmack Amendment, this FDA ruling would link a carrier’s failure to adhere to shipper-defined standards with adulteration and damages. Although not necessarily the intent, a property broker could be considered a shipper defined under the regulations as “a person who initiates a shipment of food by motor vehicle or rail vehicle.” The FDA also had sought comments on whether any “other persons engaged in the transportation of food” should be subject to the requirements. This suggests the possibility that the FDA could revise the proposed rules to expressly include brokers.

This means that the burden of proof in a cargo claim could be shifted from shipper to a carrier to show it complied with the shipper’s requirements in the event of loss or damage to the shipment.

What is the timeline for implementation?

60 days. That is the period, for large companies, in which this act will become effective after the final rule has been issued and published in the Federal Register. That means October 30th is coming quickly. For smaller companies who are not also shippers, receivers or carriers, have more than 500 employees and a revenue not greater than $25.5 annual receipts, you may have up to 2 years.

Below is a quick timeline for reference:

FSMA Timeline

Click to Enlarge FSMA Timeline

Check with Infitrak to see where and when you qualify.

Using available tools to anticipate risk

The proposed act obligates those who store and transport food to use sanitary transportation practices to ensure food safety and reduce risks. It ensures that food being transported is safe for human and animal consumption and covers adequate cleaning of vehicles between loads, proper refrigeration of food and protection of those foods during transportation. These preventive controls for human and animal food include foreign supplier verification programs.

Changes to the FDA’s rule governing hazard analysis and risk-based preventive controls will require companies to self-monitor more than ever before.

How do I assure compliance today to meet the regulations of tomorrow?

To limit your exposure to litigation or fines and help assure the safe and transport of foods, carriers, shippers, receivers and transportation intermediaries should start taking steps today to comply or facilitate compliance with the regulations. This includes updating business policies and SOPS, transport agreements and related shipping documents.

As an Infitrak customer, we can not only help you to meet these requirements through training and documentation, but can also supply you with systems that store your documents, monitor your vehicles and storage facilities, and provide you a competitive advantage.

For more information on Infitrak or on these new rules, contact Jean Bedard at jbedard@infitrak or .