Thursday, May 29, 2008

FDA Won’t Meet Deadline for Food Safety Registry

(GovExec.com – Anna Edney, CongressDaily)

The Food and Drug Administration will not meet the September deadline that Congress imposed last year to have a registry up and running to help the agency track food contamination and better understand where to focus its limited resources. FDA’s decision to operate the system using its so-called business enterprise system – which is still under construction – has hampered the implementation of the registry, according to a document the agency placed in an online database of all federal rule-making Tuesday.

The document did not explain what the enterprise business system is, and FDA did not respond to inquiries about the system. A search of the agency’s Web site also produced no mention of the system before Tuesday’s announcement. The document states only that FDA believes the system is the most effective and cost-efficient way to implement the registry.

Congress required the food adulteration registry in a comprehensive bill that reauthorized the agency’s user fee programs and gave FDA more authority to oversee the safety of pharmaceuticals, devices and food. Lawmakers allowed FDA one year from the bill’s September passage to jumpstart the registry. But now, FDA expects to implement the portal, dubbed the Reportable Food Registry, around spring 2009 at the earliest. Under the registry, food firms and federal, state and local public health officials would be required to report tainted food incidents to the electronic portal. FDA uses a disconnected reporting system operated through the agency’s district offices around the country.

FDA has talked about using risk-based inspection methods because funding has not kept pace quickly enough for the agency to inspect food facilities at regular intervals.

Lawmakers felt a comprehensive registry would produce data necessary to maximize a risk-based approach, although draft legislation proposed by House Energy and Commerce Committee Democrats would go further by requiring food plant inspections every four years, without wiggle room for risk adjusting. A similar draft measure being crafted by Senate Health, Education, Labor and Pensions Committee Democratic staff would allow for a risk-based approach if funds run low. Full story here.