The latest Food Safety Modernization Act updates for global companies

November 19, 2018

The Food Safety Modernization Act (FSMA) may be a U.S.-based regulation, but it has enormous implications for suppliers overseas who might wish to do business with a U.S. company. Adherence to FSMA is mandatory to U.S. companies, yes, but it also applies to any non-U.S. company exporting food products to the U.S.

When it was signed into law in 2011, FSMA shifted the focus of the U.S. food industry from crisis response to crisis prevention, and since has been a driver of food safety culture around the world. In 2018, many of the mandatory compliance dates for FSMA’s rules have come and gone, so at this point, companies have moved on from establishing protocols that make them FSMA-compliant and are now focusing on maintaining and improving these plans.

Still, some suppliers, particularly those outside of North America, are in the process of better understanding how FSMA affects them.

The next big FSMA rule to take effect is the one against intentional adulteration of food. It’s meant to guard against the risks posed by individuals messing with the food, for economic or even terroristic reasons. It requires U.S. companies and foreign exporters to the U.S. to address public health hazards that people with bad intentions could intentionally introduce to the company’s regular processes.

Under this rule, companies will have to develop a food defense plan, under which they will conduct vulnerability assessments, enact preventive strategies, monitor food defense, take corrective actions and verify that the plan functions. The first compliance date for this rule is coming soon — July 2019.

Foreign suppliers doing business with U.S. food companies will have to comply with this rule, as they do with other FSMA rules, like its Preventive Controls Rule, if they plan to continue exporting to the U.S.

Many of these companies may be subjected to U.S. Food and Drug Administration (FDA) inspections. Within the first year of FSMA, the FDA says it was directed to inspect at least 600 foreign facilities to identify potential food safety problems and ensure compliance with the FSMA rules. These inspections are different from audits — they don’t assess the effectiveness of the food safety system used by the facilities inspected, but they determine whether the system meets U.S. standards.

For more information on FSMA, see the rest of our blog posts on the matter here.


Category: Food Safety, Dietary Supplements, Food & Beverage, Milling & Grain, Public Health, Adulteration, Allergens, Microbiology, Pathogens, Seafood Testing, Bacterial Sequencing, Environmental Monitoring