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RegulatorySupply ChainFDAFSMATransportation

Driving the FSMA Train Forward… Looking Ahead to Implementation

April 7, 2017

This feature ensures that you are staying abreast of the latest trends and most up-to-date issues facing our food industry. The last article focused on the Food Safety Modernization Act (FSMA) Preventive Controls rule, the passing compliance date and expectations around proper execution of the rule. Next up is the compliance date for the final rule on Sanitary Transportation of Human and Animal Food in April.

Sanitary Transportation Rule: What’s Expected
The Sanitary Transportation rule was issued with the primary goal of advancing the U.S. Food and Drug Administration (FDA)’s efforts to protect food as it is distributed throughout the supply chain, keeping it safe from contamination during transportation. The prevention of practices that create food safety risks during transport is a key objective. Steps of increased concern during transportation include the cleaning of vehicles between loads, keeping cold food properly refrigerated and properly protecting food from cross-contamination.

The Sanitary Transportation rule establishes requirements for shippers, loaders, carriers (motor or rail vehicles) and receivers involved in the transportation of human or animal food. The requirements do not apply to transport by ship or air. The requirements include specific expectations around vehicles and equipment, training, records, operations and waivers.

More information is available on FDA’s website (www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461513.htm), including online courses that were developed to meet the training requirements for this rule. Guidance was also published and posted in July 2016 to assist the industry in compliance with the final rule. According to industry comments, the transportation industry should not expect huge changes in how it normally does business. While there are specific requirements as described above, the expectation from the regulatory community is the maintenance of best practices.

The Future of Regulatory Rollout
If new changes in regulatory expectations were not enough, a new administration in the White House brings even more questions around expectations and FSMA compliance. As compliance dates for the various FSMA regulations continue to roll out, many are wondering what will happen to FSMA under the new administration. Will FDA have resources for FSMA enforcement? Will guidance documents still roll out?

The food industry has invested so much in FSMA already that it would seem foolish to abandon these best practices, as they benefit all stakeholders in the food supply chain. Regardless of your politics, the food industry will still be held accountable for complying with the new FSMA requirements. While guidance is still pending on rules such as Foreign Supplier Verification, the expectation is that we continue to push ahead and be ready to execute by the compliance dates.

FDA is avowing an “educate while we regulate” approach. Such a tactic is good news; it will help the industry learn about the specifics of the regulations as the agency itself approaches the inspection and enforcement phases.

There are still positions that need to be filled in the White House that are imperative for FSMA to move forward. This could take time, as many other issues, including trade policy differences, are top of mind in Washington.

Food safety does not appear to be on the White House radar. But who in Congress could afford to vote against food safety in the eyes of their constituencies? While the timelines for rollout and compliance for FSMA remain in effect, there is always the chance for change on the horizon. These changes could include additional extensions or even additional small company exemptions. Nevertheless, our focus now should be continuing to keep food safety as the top priority in our companies, on our farms and in our stores and restaurants.

Food safety is a serious issue, and FSMA was put in place to help us control and reduce hazards and risks that can cause harm or illness. Stay focused. Share with your comrades in the industry and get involved. Many industry groups are working hard to dig through the rules and create best practices and tools for ease of compliance.

Times are changing and, with them, the regulatory landscape. How you perform will depend on your willingness to invest in understanding the spirit of the rules and begin building your platform for success.

 

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