Tom Harkin: “As my colleague, the distinguished Chairman of the Subcommittee may know, I have been advised that the Food and Drug…”

“As my colleague, the distinguished Chairman of the Subcommittee may know, I have been advised that the Food and Drug Administration Modernization Act of 1997 (FDAMA) authorized a new streamlined pre-market notification system for food packaging materials. The current regulatory process involves significant delays, resulting in lost sales and decisions not to bring new products to market that would improve food safety and protect the public health. The new notification system will substantially reduce the length of the FDA review process and allow the introduction of advanced packaging materials. The Agency will still, however, receive all of the information needed to establish the safety of packaging materials and will continue to be able to keep unsafe materials off the market. I also have been advised that FDAMA requires that certain funding criteria be met for the program to take effect as scheduled on April 1, 1999. The Act calls for funding of the pre-market notification program at a level of $1.5 million in FY 1999. I note that the counterpart legislation passed by the House Appropriations Committee currently provides for the sum of $500,000. It is my hope that the distinguished Chairman of the Subcommittee will further address this issue in conference in order for the FDA to implement this important reform as intended by Congress.”