The Food Safety Modernization Act (FSMA) is the first major update of federal food safety laws since 1938. With its implementation on April 6th, 2017 many looming compliance and regulatory questions have come to the table. We've outlined the top 10 questions about this new regulation.
1. What is the FSMA?
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them.
2. What changes were made from the proposed rule?
- The definition of "transportation operations" has been changed to exclude: transport of foods enclosed by a container, all transportation activities performed by a farm, transport of human food byproducts for use as animal food without further processing, the transport of human food byproducts for use as animal food, transport of food contact substances, and transport of live food animals.
- "Loaders" have been added as a covered party. A loader is a person who physically loads food onto a motor or rail vehicle.
- The shipper and carrier can agree to a temperature monitoring mechanism for foods that require control for safety.
- Primary responsibility for determining appropriate transportation operations now rests with the shipper.
See the full list of changes on the FDA website.
3. What is the Sanitary Transportation of Human and Animal Food Rule?
This act went into effect in 2005 and requires that the FDA prescribe sanitary transportation practices to ensure that any food transported by a motor vehicle or rail is not transported in any way that might tamper with the food.
4. What are examples of sanitary transportation practices that will be required under the Sanitary Transportation of Human and Animal Food?
- Prior to loading, loaders are required to determine that a vehicle is in the right condition to transport food, meaning good physical condition, no infestation, etc.
- If you transport foods that required time or temperature control, ensure the maintenance of the transportation cold chain during operations, such as pre-cooling, loading and unloading operations, and the actual transportation itself.
- Both the shipper and carrier should maintain written procedures that detail sanitation and temperature processes - meaning, there must be proof that the procedures are followed.
5. How will the FDA implement and enforce the Sanitary Transportation of Human and Animal Food?
The DOT will be inspecting vehicles during safety inspections by the DOT or state personnel. The FDA states it will take action when agency efforts to work with a company fail to result in compliance.
Inspections will essentially ask - what did you do to get the product from point A to point B successfully, safely, and cleanly?
6. What are the consequences for noncompliance?
This ruling is rather strict in its compliance to keep food from becoming adulterated. The FDA is requiring registration, certification, and prior notice for all non-U.S. farms, carriers, and shippers involved in food transportation. Without it, the FDA is allowed to seize, hold, or destroy any products.
See the full enforcement here.
7. Is there any training available from the FDA?
Carriers must provide basic sanitary transportation practice training to their personnel. The FDA does provide training to meet this requirement, but they will only cover the basics. Services are beginning to develop around this that will bring you high quality training that goes above and beyond the basic requirements.
You are responsible for training all employees involved in the transportation process and you must document this training effectively. Even temporary employees should be trained in this area - with tenured employees, your goal should be to build a culture surrounding the compliance of this act.
8. What is the deadline for all adjustments to be made?
Recognizing that businesses, especially small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.
- Small Businesses - 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 (April 6th, 2018).
- Other Businesses - a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule (April 6th, 2017).
9. Who is exempt from the rule?
Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue.
- Transportation activities performed by a farm
- Transportation of food that is transshipped through the United States to another country
- Transportation of food that is imported for future export and that is neither consumed or distributed in the United States
- Transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products) and food contact substances
- Transportation of human food byproducts transported for use as animal food without further processing
- Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety
- Transportation of live food animals, except molluscan shellfish
10. Where can I learn more?