Foreign facilities falling behind on FSMA, consultant says

Ben England, principal in the consultancy FDAImports.com​, said many operators of food facilities in China seemed unaware of the requirement and the approaching deadline.

“Chinese food companies are simply not aware of impending FSMA regulations, including the new food facility biennial registration requirements,”​ he told NutraIngredients-USA.

“But this is not unique to China,”​ England said, who recently completed a training trip in that country, where FDAImports has a subsidiary. “I was in Mexico two weeks before China and they had the exact same confusion there, and they are just south of the border.”​

First phase of biennial requirement​

The 2003 Bioterrorism Act required food facilities, including those overseas that are producing goods exported to the US, to register with FDA.  Under FSMA, those registrations must be updated by Dec. 31 in the first go round of what is now a biennial requirement.

Part of the paperwork for bringing product into the US will include a review of those registrations.  If a shipment is on the dock on Jan. 3 without a new registration, it may be refused entry.

“Nobody knows what the FDA will do.  Better to be compliant, is what we are telling our suppliers,”​ said Gabriela Zalman, purchasing manager for ingredient supplier PL Thomas.

England said the original registrations in 2003 gave a company a way to bring its registration up to date and “cure” an import refusal.  He said a similar situation could occur with this first phase of re-registrations, though no one knows for sure.

Attorney Marc Ullman of the firm Ullman, Shapiro and Ullman was more definitive.  With up-to-date documentation, he said, “You can’t sell.”​

“This is a world wide problem,” said England. ​“If you’re buying from a foreign supplier, they need to be moving on this.”

England said inevitably the re-registrations will pile up close to the Dec. 31 deadline.  Companies likely will be scrambling to locate the necessary information such as credentials and passwords.

“They did it one time and they probably did it about 10 years ago.  The person who did probably left the company about 5 years ago,”​ he said.

It pays to make sure your suppliers are registered​

Neither Ullman nor Zalman painted as dire a picture as did England.  But then again, they both view the picture from North America, where the regulations are (presumably) better understood. But they both agreed that companies bringing in product from foreign sources need to be highly proactive to avoid having an interruption.

“Many of the manufacturers we are already working with are already registered before and are familiar with the process so it’s not a big issue. Some are asking for help so we are helping them,”​ Zalman said.

“It took a while for everyone to realize that FDA was serious first time around (in 2003).  There might be a period where there are a few hiccups,”​ Ullman said.

“But for the US-based customers on the receiving it is generally in their best interests to make sure their suppliers are registered so that they can get the raw material they need. If they are shut down, you are shut down,”​ he said.