FDA Reauthorization Legislation Approved By Senate

Press Release

The United States Senate today approved the Prescription Drug User Fee Act, S.1082, commonly referred to as the FDA Reauthorization bill. The bill as passed includes an amendment offered by U.S. Senator Dick Durbin (D-IL) that will strengthen the nation's food safety system. The U.S. Food and Drug Administration (FDA), one of the federal agencies charged with safeguarding the U.S. food supply, has come under fire recently in the wake of nationwide recalls and quarantines of tainted pork, spinach, peanut butter and pet food. Today the Senate approved the FDA Reauthorization bill by a vote of 93 to 1.

"With the passage of today's legislation, we have begun to address the growing food safety concerns across our nation. My colleague, Congresswoman DeLauro, will be working to include this measure in the House version of the bill and we will be working together to ensure that the House and Senate include it in the final version when they go to conference on the bill," said Durbin.

Durbin's amendment establishes an early warning and notification system for human food, as well as pet food, establishes fines for companies that don't promptly report contaminated products, improves inspections/monitoring of imports, and provides better, more uniform pet food safety standards. Durbin's amendment was accepted last Wednesday as part of the FDA Reauthorization bill last week by a vote of 94-0.

Some of the new responsibilities given to the FDA under Durbin's amendment include:

# Establishing an early warning and notification system for human food as well as pet food products. The legislation directs the FDA to work with professional organizations, veterinarians, and others to disseminate information about pet food contamination and in cases of both pet and human food, to keep up to date, comprehensive, searchable recall lists on their website.

# Improving FDA's ability to detect problems, and alert consumers of contaminants by creating an adulterated food registry for imported and domestically produced food. The amendment requires the FDA to establish a registry to collect information on cases of potentially dangerous food adulteration to improve risk-based surveillance of food safety and improve the speed at which consumers and firms are notified. Importers and domestic processors and manufactures of food would have to submit information pertaining to actual or suspected adulteration of food. The submission would be made to the FDA for inclusion in a centralized database through an electronic portal. The sources of the recent human and pet food contamination were wheat gluten and rice protein concentrate that originated in China. Neither shipment was inspected by FDA; in fact, FDA inspects fewer than 1.5% of imports. A database would give FDA better information on which to base inspections.

# Requiring companies to maintain records and make them accessible to FDA as part of an investigation. This provision would prevent delays that could keep contaminations from being traced as quickly as possible. In the case of the recalled peanut butter this past winter, an FDA report showed that inspectors were denied documents when they requested them. The bill would clarify that when FDA conducts inspections, it will have timely access to those documents needed to safeguard the food supply.

# Establishing uniform federal standards and better labeling of pet food. The guidances and practices that today govern the pet food industry are implemented on a voluntary basis by manufacturers and state departments of agriculture. However, there is no requirement for states to adopt these practices and they don't have the force of federal guidelines. Inspections are not coordinated state to state and some states have different standards than others.

Senator Durbin and Congresswoman Rosa DeLauro (D-CT) have been actively engaged on food safety issues for over a decade. This Congress they introduced legislation that calls for the development of a single food safety agency and the implementation of a food safety program to standardize American food safety activities (The Safe Food Act - S. 654 and H.R. 1148 in the Senate and House respectively). Currently, there are at least 12 different federal agencies and 35 different laws governing food safety. With overlapping jurisdictions, federal agencies often lack accountability on food safety-related issues.

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