FDA Making Progress on FSMA Implementation; Six Elements 'Key' for Importer Compliance
The Food and Drug Administration has yet to publish several major rules related to implementation of the Food Safety Modernization Act, but has made a lot of progress, said Domenic Veneziano, director of FDA’s new Office of Enforcement and Import Operations, at the Food Chemical News’ Complying with FSMA’s Food Import Regulations conference Dec. 4 in Washington, D.C. Proposed rules on the Foreign Supplier Verification Program and Third-Party Accreditation have been submitted for Office of Management and Budget approval, and these programs, among others, will serve as important tools given FDA’s resource constraints, he said.
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Success of implementation will also depend on new strategies to work internally and with partners, Veneziano said. To this end, senior officials at FDA’s food program have developed an operational strategy that will be used to guide newly-created FSMA operations teams (FOT). FDA has also created six major teams on preventative standards, inspection and compliances, importers, federal integration, fees, and reports and studies.
While FDA is still working out the specifics of FSMA, Veneziano identified six key elements of compliance that will put importers in a good position to implement of FSMA, the Food and Drug Administration Safety and Innovation Act (FDASIA), and any other rule the FDA may put out. They include:
Knowing the supply chain. "FSMA is all about responsibility and accountability of everyone along the supply chain," said Veneziano, so importers should know who they’re doing business with. This includes the manufacturer and its compliance status, and specifics on audits of manufacturers. Also important is knowledge of who is serving as the importer of record (IOR), and whether the IOR knows the intended use of the product. Importers should also know whether the IOR participates in voluntary programs such as C-TPAT and ISA, as well as the upcoming Voluntary Qualified Import Program, he said.
Another important consideration is whether the filer is on dual mode or paperless filing. Dual mode filers do not get priority for expedited releases, Veneziano said.
Understand Section 801. Importers must understand Section 801 of the Federal Food Drug & Cosmetics Act (FD&C Act), which covers import alerts and refusals, Veneziano said. Once FDA establishes the appearance of a violation, all future shipments are subject to import refusal. In this global world, information on potential violations can come from anywhere, he said, including foreign governments.
Know your rights.The owner or consignee has the right to a hearing should FDA decide products are subject to import refusal, Veneziano said. This hearing can be in the form of a meeting with FDA, and not just submission of lab data. Importers have 10 days from the time of detention to request a hearing, subject to extension, he said. If no hearing is requested, FDA will not rescind refusal of the product unless it determines it made a mistake.
Understand the import alert system. It is important to understand how to get off import alert, he said. Currently, the import alert system notifies the owner of the goods, consignee, and filer. The importer of record is ultimately held responsible, so it is up to them to notify others, including the manufacturer, that the product has been placed on import alert, Veneziano said.
Know required data elements. Importers should know required data elements and keep up to date with new legislation, Veneziano said. They need to know what’s coming down the road with FSMA and FDASIA, which have different requirements. Recordkeeping and registration requirements are also important to know, he said.
Know FDA contact info. Finally, importers should be familiar with the district office where the goods are entered, and have contact information on hand, Veneziano said. Headquarters contacts are also important to know, as the Office of Enforcement and Import Operations has a rotational duty officer available to answer questions. By giving this duty officer the entry number for the goods in question, FDA can look up the shipment, determine what the issues are, and refer the importer to the appropriate district office. The duty officer is reachable at (301) 796-0356.