FDA moves food data faster

FDA registration site

A new electronic registration system is expected to cut the time required for upfront processing and long-term prevention and reaction measures in the Food and Drug Administration's food safety division.

FDA officials developed the registration system, which went online Oct. 16, to fulfill part of their responsibilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In the final regulations, published last month, all facilities that process food for use in the United States must register with the FDA.

Registration serves multiple purposes. First, it will create a database of facilities that the agency can search when, for example, a contamination occurs and officials need to contain the problem. The registration account also addresses how the FDA will identify groups importing food every time they use the Prior Notification System Interface, which will come online Dec. 12.

In the past, this type of registration would have occurred entirely through mail-in responses or in person. Now, FDA officials are pushing the private sector to use the Web-based registration as much as possible.

"No matter what [non-Web] form we get it in, we're going to hand-enter the data, so it's going to be a slower response," said Sebastian Cianci, a spokesman for the FDA's Center for Food Safety and Applied Nutrition. "We strongly recommend electronic means because we can send the registration information back immediately."

As of Nov. 11, more than 37,000 of the expected 425,000 registrations have come via the Web, Cianci said. More than 2,000 facilities registered via the Web within the first three days. All facilities must register by Dec. 12, and agency officials hope to avoid a crush of last-minute registrations, Cianci said.

FDA officials have worked closely with industry on the move to the new system, said Rick Jarman, vice president of food and environmental policy at the National Food Processors Association. Agency officials consulted industry leaders several times to test the system while it was still under development, he said.

FDA officials spent more than a year working on the system, including developing requirements for it, and ended up using several existing contractors and awarding a new $4.5 million contract to SRA International Inc., Cianci said.

The contractors developed the registration system specifically for the FDA, but the agency is using off-the-shelf reporting tools to pull information from the database.

Association officials are pleased that the system will allow central or distributed registration for companies with multiple facilities, Jarman said. It recognizes returning visitors and automatically fills in their basic information, he added.

"It became very clear that this was a fairly straightforward and logical system that they had designed," he said. Electronic submissions are "relatively new for the FDA. In many ways, they are breaking new ground with this."

The agency has spent much of this first month on education and awareness to teach people what they need to do to register. Officials may grant organizations some leeway to miss the deadline if agencies make it clear that they are trying to meet the requirements, Cianci said.

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Electronic notice

Although food handling, packaging and processing facilities can register with the Food and Drug Administration via the Internet or more traditional methods, the agency strongly encourages electronic registration because it is faster and more efficient.

Internet registration:

* Is available 24 hours a day, seven days a week, worldwide wherever the Internet is accessible.

* Will not allow registration to be submitted until all mandatory fields are completed.

* Provides automatic receipt of registration and the facility's registration number.

* Is publicly available at places such as libraries, Internet cafes and copy centers.

Paper registration:

* Is a much slower process. The FDA estimates it can process 1,800 paper registrations per day.

* Requires that forms be legible and complete, otherwise delays will occur.

* Is more labor-intensive. FDA workers enter the information on the forms and assign each facility a registration number in the order the forms are received.

Source: Food and Drug Administration