WASHINGTON -- Under a tighter-than-usual deadline, the Food and Drug Administration is preparing to issue draft regulations related to food industry security by early January 2003 as part of the Bioterrorism Preparedness and Response Act of 2002.
The FDA's Center for Food Safety and Applied Nutrition has established working groups to craft the language to be used in the new law.
"We were given 18 months to go through the whole writing process prior to approval and publishing. For any of you who have dealt with government agencies before, that is record time," noted Robert Brackett, director of CFSAN, which is leading the FDA's contribution to the multi-agency effort.
Passage of the legislation has put pressure on agencies like FDA because final implementation of the law is scheduled for Dec. 12, 2003 -- and certain key provisions will take effect even if they fail to meet the deadline.
One group in particular is responsible solely for enhancing interdepartmental communication between the FDA and the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, and the Environmental Protection Agency, among others. All are already part of the Food Threat Preparedness Network, formed right after Sept. 11, as "an informal discussion group" on security-related issues.
"The initiative also includes meeting with consumer groups, and industry and other federal agencies to try and get input before we start writing; it involves conference calls with all 50 states to make sure all geographic [regions] have input into the legislation," said Brackett.
The law means changes for the food industry. One clause will require manufacturers and processors to register facilities with the government, as well as to maintain more specific production and shipping records, according to Brackett. There are many new areas of responsibility the FDA is delving into. Under the law, the FDA can now hold product and ban importers for repeat violations. Additionally, refused shipments will be marked to prevent port shopping, he said.
"This wasn't so much because we thought imports were any more or less of a hazard than domestic products, but because of the volume of product that's coming into the country," said Brackett, noting that five million line entries for imported food, cosmetics and supplements were recorded in fiscal 2001. The number is somewhat deceiving to a layman's eyes because the term "line entry" refers to batches or groups of items shipped together, and does not reflect the fact that there may be 20,000 individual consumer units in that group -- each one for retail sale, according to an FDA spokesman.
Back-office operations are also in need of modernization. For example, the agency must devote extensive resources in the coming months to develop and expand its laboratory capabilities. The FDA has established stronger networks of compatible lab space for crisis times, such as last year's anthrax attacks when there was "a tidal wave of samples that flooded into our labs," Brackett recalled.
"The one thing FDA is good at is emergencies," he said. Today, the agency is working with the industry and other agencies to develop mock crises to ensure the system can handle peak testing periods.
"They're used to handling traditional foodborne disease organisms," he said. "Many of our labs have to be upgraded to now deal with organisms we've never had to deal with before."
An administrative issue in need of attention looks at how the FDA can process sensitive information and share it with the industry without compromising security. Brackett said FDA staffers have developed thorough threat assessments on various aspects of food security, only to have the completed documents declared classified by higher-ups.
"It was quickly decided to classify them because they are a roadmap for terrorists. So many of the documents that the staff wrote they can no longer read until they get clearance. We're not used to operating like that," he said.
Many of the assessments were developed to help the industry identify some of the threats. An ancillary problem involving the whole question of how to approach the classification issue involves determining how FDA can still get the information to the industry "without somebody who would like to damage the industry from getting a hold of it," he said.
The FDA earlier published suggested guidelines for the industry, specifically for processors and importers. The documents are now undergoing revision to include retailers, he said, noting they are available from the FDA's Web site, fda.gov.
