Under FSMA Section 201, the FDA is required to significantly increase the frequency of its domestic and foreign inspections. “FDA inspectors are limited, and they can only spend so much time in plants during routine inspections. But by looking at records, they can identify areas for further investigation,” Dr. Henry said. As Taylor noted in his Orlando speech in February, the FDA may want not just the certificate of a third-party audit, but also the entire audit itself. “This will be a very significant lift for everybody when this program becomes implemented and measured by what the enforcement actions are taken for non-compliant facilities,” Dr. Henry predicted.
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The key concept is “business continuity” of the entire supply chain—from field to restaurant or retail grocer. “The challenge for industry now is validating the integrity of the food safety systems being used to supply their upstream supply chain,” Dr. Henry said. Instead of relying on third parties to certify ingredients, companies will need to be more aggressive and invest more time and money, especially if the external supply chain is important to their brand. “They really need to make sure they know what’s going on and not assume all is well, especially with FDA inspections picking up,” he said.
While most large companies may be able to undertake the extra effort, FSMA requirements could overpower small- and mid-sized companies so that they are unable to compete, said Benjamin England, chief executive of FDAImports.com, a firm that represents importers seeking to navigate U.S. import and other regulations.
“The costs to small- and mid-sized importers will likely become severe in coming years, regardless of any exemptions that FDA might hand out to them,” England told the Food and Drug Law Institute’s annual conference in May. “These companies simply don’t have the relations with foreign suppliers necessary to implement the statutory language. This will cost U.S. jobs, reduce competition, and produce more very large food companies, which is not necessarily better when it comes to food safety,” he added.
One of the main ways this can happen is through product detention. Running afoul of FSMA requirements can result in products being placed on the FDA Import Alert list, said Rick D. Quinn, an attorney with FDAImports.com. The Import Alerts, also called FDA automatic detention lists, instruct import inspectors, investigators, and compliance officers to automatically detain or detain without physical inspection all imports of affected products from the listed manufacturer, shipper, grower, or even geographic area. Once a product or company is placed on the list, it can be very challenging to convince the FDA that the violation has been corrected.
“FSMA imposes many new requirements on importers and food companies, so there will be many more opportunities for companies to be put under import alerts,” Quinn told Food Quality.
Ted Agres is based in Laurel, Md. Reach him at firstname.lastname@example.org.