FDA to Soon Detain Goods on "Belief," Require New Info for PNs, Etc.

Starting July 4, Prior Notice Must Say if Another Country Declined Food

He stated that starting July 4, 2011, if a food was refused entry in another country, this must be reported in the Prior Notice to FDA. Acknowledging that it might be difficult for a customs broker to know this fact, he suggested they put in place a process to ask the importer.

The official also said that this Prior Notice provision is proving to be a challenge for FDA to implement. This is because it requires technology changes to FDA’s system, but the agency cannot legally spend money on new projects under continuing resolution budget funding. Therefore, it has been trying to prepare the ground work to implement the change whenever the funding comes, in the hope it will be able to meet the July deadline.

Soon FDA Will be Able to Detain Products Based on “Belief” not “Evidence”

According to the official, another important but often overlooked FSMA change is the lowered threshold for FDA to detain products. Within 120 days of enactment, FDA must issue an interim final rule lowering the threshold for administrative detention to a “reason to believe that such article is adulterated or misbranded” (from “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals”). He said that the old standard was too high and impeded FDA’s ability to detain food it suspected.

If Foreign Facility Refuses Inspection, FDA Can Deny Entry of Food

He reminded the trade that under the FSMA, FDA is able to deny entry to imported food from a foreign facility that refused to allow FDA investigators to enter for inspection.

He also noted that meeting the FSMA’s requirements for increased foreign and domestic inspection of facilities will be a challenge for FDA due to a lack of resources to conduct them.

Study on Protection of U.S. Food Supply Will Lead to Regulations

FDA is also required to conduct a vulnerability assessment of the U.S. food supply against intentional adulteration and put together a classified report. According to the FDA official, this study would lead to regulations and guidance 18 months after FSMA’s enactment on protecting the food supply against intentional adulteration.

FDA Must Work with DHS to Better Identify Smuggled Food

FDA must also coordinate with the Department of Homeland Security to develop a strategy by July 4, 2011 to better identify food smuggled into the U.S.

FDA Has to Open More Foreign Offices

In addition, FDA has to come up with strategy for opening more foreign offices to improve the safety of food imported into the U.S. and increase capacity in other countries. This would be done through sharing of reports, training, bilateral agreements to coordinate efforts, etc.

(The official also discussed, but did not add new information on, the major import provisions of the FSMA such as the foreign supplier verification program, the voluntary qualified importer program (VQIP), the accreditation of third-party auditors, and certification of high-risk foods. He also reminded the trade to submit comments on these FSMA import provisions by April 29, 2011.)

(See ITT’s Online Archives 04/08/11 news, 11040822, for BP summary of FDA saying that imports, controls and inspection are among its top FSMA priorities.

See ITT’s Online Archives or 03/31/11 news, 11033124, for BP summary of FDA seeking input from importers on major FSMA provisions such as the 2012 Supplier Verification System.

See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA.)