— by Gabriella Agostinelli

As of June 25, at least 122 people have been confirmed to have contracted Hepatitis A after consuming a frozen fruit mix sold at Costco. Hepatitis A often spreads when “an infected food handler prepares food without appropriate hand hygiene.” At least 11 lawsuits have already been filed on behalf of persons who became ill.

If you import it, you are responsible for it.

This outbreak is newsworthy because it involves contaminated food products of foreign origin.  The mix, called Townsend Farms Organic Antioxidant Blend, included berries from the US, Argentina and Chile, as well as pomegranate seeds processed in Turkey. Townsend Farms has since reported that the outbreak has been traced to the pomegranate seeds. This report has prompted another company, Scenic Fruit Company of Oregon, to recall its Woodstock Organic Pomegranate Kernels simply because they also are sourced from Turkey, even though none of its product has tested positive for Hepatitis A and no illnesses have been linked to its product.

We can’t help but wonder whether these personal and business losses may have been avoided if federal regulators complied with federal law.  In January 2011, President Obama signed the Food Safety Modernization Act (FSMA) into law, an act enabling the FDA “to better protect public health by strengthening the food safety system.” Among its many functions, the law gave the FDA certain tools and authorities to make imported foods meet the same safety standards as foods produced in the US.

One of these tools is the Foreign Supplier Verification Program (FSVP), which obligates food importers to conduct risk-based foreign supplier verification activities to ensure imported food is not adulterated and that it is produced in compliance with the FDA’s preventive controls requirements and produce safety standards. These activities include “monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.” FSMA § 301.

The FSMA required the FDA to develop and implement these protocols by January 2012. As of today, no such protocols have even been proposed by FDA. The Center for Food Safety (CFS) brought suit against the FDA last August for failing to adhere to its deadlines. Last week, the court ordered FDA to complete its FSMA rule-making by June 30, 2015.

If FDA had adhered to the original deadline, the US importer of the Hepatitis A-tainted pomegranate seeds may have begun the food safety protocols that could have prevented the outbreak. The law contained a deadline for a reason — to expeditiously implement standards to enhance consumer safety.

Bear in mind, however, that civil liability is ultimately assigned to food producers in the event of an outbreak. Whenever a producer/manufacturer imports foreign ingredients, they are ultimately responsible for protecting against the risks of contamination, not the FDA. Food producers who import ingredients should not simply be waiting around for the FDA to implement these new protocols before taking action. Producers should take steps now to make sure they are using highest food safety standards possible. After all, even federally-compliant producers are susceptible to outbreaks.