FDA Considering U.S. Agent Notification in Final FSVP Regulations
The final regulations on the Foreign Supplier Verification Program will provide more clarity on the responsibility of U.S. agents for fulfilling program requirements, said Food and Drug Administration (FDA) officials at a Jan. 14 webinar hosted by the National Customs Brokers & Forwarders Association of America (NCBFAA). Foreign entities will be able to designate a representative that is not the Bioterrorism Act U.S. agent for FSVP purposes, they said. The agency is also considering a system where that U.S. agent or representative must give consent to be identified as such under the FSVP.
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Under the July 29 FSVP proposed rule, the “importer” tasked with fulfilling the program’s requirements could be the “U.S. agent or representative” of a foreign entity if there is no U.S. importer of consignee (see 13072628). In comments submitted Nov. 14 on the FSVP proposal, NCBFAA expressed concern that the “U.S. agent” required by the Bioterrorism Act for communication with a foreign entity, and more recently for food facility registration, would be saddled with FSVP compliance as well. There is currently no mechanism for U.S. agents to be notified when they are designated by a foreign entity. If FDA means to add another layer of liability for U.S. agents, then it at least needs to come up with a notification system, NCBFAA said (see 13111523).
The language making the “U.S. agent or representative” in some cases liable for FSVP compliance was put in the Food Safety Modernization Act by Congress, said Domenic Veneziano, director-Division of Import Operations. FDA is going to clarify in its final FSVP regulations that the Bioterrorism Act U.S. agent won’t necessarily be the “U.S. agent or representative” for FSVP purposes, said Veneziano during the webinar. “We are going to provide some clarification language in the rule,” he said. “It doesn’t necessarily have to be a U.S. agent. It could be a [representative] of the foreign entity.”
“Clearly we’re talking about an entity in the United States that is capable of conducting the foreign supplier verification activities,” added Brian Pendleton, acting director of compliance at FDA’s Center for Food Safety and Applied Nutrition. “It wouldn’t make sense for someone to do that who is not,” he said. “I think the intent of the statute is that there needs to be someone in the United States that understands the issues concerning the importation of that food, and is able to conduct these verification activities that FDA can in turn verify are being conducted, so there is this entity in the United States that can provide this additional component of food safety protection.”
FDA is also considering a notification system so the FSVP “U.S. agent or representative” isn’t unknowingly designated as such. “We have had a lot of questions and some concerns by those who are concerned that they might be named the U.S. agent or representative by the foreign owner, and not be told of that,” said Pendleton. “Essentially, they would be subjected to the FSVP requirements and not even know that they were designated as the agent or representative,” he said. “We are considering how we might address that, for example possibly by saying that a designation of a person or an entity as the U.S. agent or representative of the foreign owner or consignee would not be valid unless that foreign owner has documented the consent of that person to be the agent or representative.”
Comments on FDA’s proposed FSVP rule are currently due Jan. 27.