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Smooth Sailing So Far For FDA’s New Bioterrorism Rules

April 24, 2008

4 Min Read
Smooth Sailing So Far For FDA’s New Bioterrorism Rules

Rules set by the U.S. Food and Drug Administration to reduce potential bioterrorism threats related to food delivery have not caused problems for retailers, store operators report.

?We?ve seen a couple of things here and there,? says James Watts, operations manager at Weaver Street Market in Carrboro, N.C. ?We had some wine held up in customs in October, and we?ve run into a couple of situations where coffee was out of stock because a container was awaiting inspection. But these things have always happened.?

One reason for the smooth sailing so far may be because compliance with the new rules is not yet complete. It may just be too soon for the rules? impact to be felt at the retail level, store operators say.

The rules require handlers of imported food and supplements products to register their facilities with the FDA and to notify the agency prior to food shipments arriving on U.S. soil. Two hours? advance notice is required if the shipment arrives at the border by truck, four hours? if shipments arrive by train or plane, and eight hours notice is required if the arrival is by ship. Retailers are exempt from the facilities registration and prior-notice reporting requirements.

The rules became effective Dec. 12, 2003. By that date, more than 400,000 facilities worldwide that handle food were supposed to have registered with the FDA. That has not happened to the extent that the agency had hoped, despite its attempts to make registration as easy as possible, says Kim Smith, director of legislative affairs at the National Nutritional Foods Association in Washington, D.C. The FDA rules allow food handlers to register online, at, via fax or through the mail.

?The problem overseas is probably the language barrier and the need for a U.S. agent,? Smith says. Small suppliers overseas may not be aware that they were supposed to register by mid-December in order to continue shipping products to stateside addresses.

The rules also require foreign food suppliers to have a designated U.S. agent with a physical location in this country. The registration cost for a foreign supplier is about $500, Smith says.

The FDA is using its discretion in enforcing the new rules, but that will change. In December the agency signed an agreement with U.S. Customs and Border Protection that allows it to commission thousands of border patrol officers to investigate and examine imported food shipments. Both agencies say there will be a multimonth, phase-in period during which they will concentrate on educating firms that have not yet registered or given prior notice of shipments arriving at U.S. borders or ports. But both agencies say they also will begin imposing escalating monetary penalties during that time. Ultimately, if shippers do not comply with the FDA rules, their shipments will be refused at the border.

The phase-in period will end Aug. 12. Whether bottlenecks in the supply chain begin to appear after that date, only time will tell.

But another new section of the FDA?s bioterrorism rules could impact retailers to a much greater extent than either the facilities registration or prior-notice rules. That?s the proposed section on recordkeeping. The idea behind the recordkeeping rule is to establish a paper trail from creator to retailer for every food product sold in the United States. For retailers, that means logging, in detail, every delivery they receive.

According to the FDA?s Web site, the proposed section would require retailers to log the name of the manufacturing firm; the responsible individual; address; phone number; fax number; e-mail address, if available; type of food, including brand name and variety; date received; lot number or other identifier; quantity and type of packaging; and the name, address, phone number and, if available, fax number and e-mail address of the transporter who delivered it. The records may be kept in paper or electronic form, but they must be available to the FDA on short notice.

According to Ed Steele, vice president of food, dietary supplement and cosmetic consulting for Rockville, Md.-based AAC Consulting, the proposed recordkeeping section was supposed to be finalized Dec. 12, 2003, along with the facilities registration and prior-notice rules. Now he expects the proposed section to be published in March. He also expects the rule will have a phase-in period of six to 18 months, depending on the size of the firm. ?Larger firms will have to comply sooner, smaller firms later,? he says.

Retailers would not, under the proposed recordkeeping section, be required to record individual sales made to consumers.

?Everyone in the [food] supply chain has to identify one before and one after, except retailers,? says Steele.

Larger retail chains that use supply-chain software will find the recordkeeping rules not so onerous; for them, it will be a matter of adding new database modules to their existing inventory-management systems. But for smaller stores, like Weaver Street Market, the implementation costs could be higher. ?We?d have to hire someone to do that job,? Watts says.

Nancy Nachman-Hunt is a free-lance writer and editor in Boulder, Colo.

Natural Foods Merchandiser volume XXV/number 3/p. 70, 74

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