(Oct. 1) Only half the number of worldwide food facilities originally estimated as needing to register under Food and Drug Administration bioterrorism regulations have done so, officials say.

The Bioterrorism Act of 2002 requires all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA. The deadline for registration was Dec. 12.

As of Sept. 17, the FDA said the agency had received 221,450 registrations. Of that number, the FDA said 118,963 were foreign and 102,487 were domestic.

However, the FDA had originally expected 420,000 registrations, of which it anticipated half to be domestic.

“It is certainly one of the possibilities that we overestimated,” said Sebastian Cianci, spokesman for the FDA.

However, Cianci said it was important for all domestic and foreign facilities to register if they have not done so.

In a Sept. 22 statement, the FDA said it hopes the educational focus of the agency since the Dec. 12 deadline has not caused companies to delay registering.

Stricter enforcement of the prior-notice provision, including scrutiny of inaccurate or absent registration numbers, will begin Nov. 2, Cianci said.

The agency issued a compliance policy guide in December to provide direction on the agency’s strategy for enforcing the interim final rule on prior notice. The compliance guide noted that the FDA’s focus on education will switch to harder enforcement Nov. 2.

For foreign facilities, the FDA enforces the registration requirement through the prior-notice process by requiring the registration number of the foreign food manufacturer and shipper as part of the prior notice.

Domestic facilities should register in case of food security threats and traceback investigations, Cianci said. They too are in technical violation of the law if they fail to register, he said.

In statistics released by the FDA, the agency said Mexico has submitted 7,300 registrations of the nearly 119,000 foreign food facilities registered. Canada recorded 9,363, China had 9,680, France 8,764, and Japan had 15,546 facilities registered.