May 6, 1999

The Honorable Thad Cochran
Chairman, Subcommittee on Agriculture, Rural Development And Related Agencies
Committee on Appropriations
United States Senate
SD 136 Dirksen Senate Office Building
Washington, DC 20510-6150

Mr. Chairman:

The Society of the Plastics Industry, Inc. (SPI) appreciates this opportunity to submit these comments to the Senate Appropriations Committee Subcommittee on Agriculture, Rural Development, and Related Agencies in support of full funding for the implementation by the Food and Drug Administration (FDA) of the recently enacted Food-Contact Notification (FCN) program.1/

The FCN program, passed as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA)2/, will significantly reduce the time and cost currently involved in marketing a new food packaging material. The program will promote the development of new packaging materials, including new products that will improve food safety and protect public health. In addition, the more efficient FDA clearance of new food packaging materials will benefit the packaging industry, which is an important sector of the national economy, employing thousands of workers across the United States in a wide range of industries including plastics, metals, paper, and chemicals. Improving the process for bringing new packaging materials to market also supports the much larger consumer products industry.

In the budget for the current fiscal year, Congress included the following language in the FDA section of the Omnibus Spending bill: "an amount of $500,000 shall be made available for the development of systems, regulations, and pilot programs, if any, that would be required to permit full implementation, consistent with section 409(h)(5) of that Act in fiscal year 2000 of the food contact substances notification." We understand that FDA has used this money to begin developing guidance and procedures to implement the FCN program at the beginning of the FY 2000, provided that sufficient monies are appropriated to administer the program in the FY 2000 budget.

SPI supports funding for FDA in the amount specified in FDAMA, $3 million dollars. SPI is concerned that, without adequate and consistent funding for the FCN program, FDA will not have the resources to administer the program as intended by both industry and the Agency. It is extremely important that the FCN program be implemented in the manner envisioned, so that it replaces the petition process for food-contact materials. To ensure that this program operates as intended, FDA must be assured that it can rely on having the resources to conduct appropriate reviews within 120 days. Therefore, we urge this Subcommittee to support appropriation of the funds that were authorized in FDAMA for this purpose.

The President's FY 2000 budget contains provisions to fund the review of direct food additives, indirect additives (i.e., food-contact substances), and medical devices through the use of industry-paid fees. As in the past, SPI and its member companies support such fees if they are reasonable in amount and if they are dedicated to administering the FCN program and expediting the review of food-contact substances. We understand that the Administration intends to submit a legislative proposal to authorize fees for these programs. While the specifics of the fee proposal have not been made available to the public, the plastics industry's support is contingent upon the fees being reasonable, i.e., in the range of a maximum of $3,000 per notification.

An appropriate fee system would guaranty ongoing funding for this program, and provide FDA with the certainty it needs to designate the appropriate resources to administer the FCN program. SPI believes it is reasonable for industry to help defray the cost of this type of Agency action, which represents a direct benefit to the companies filing the notifications. In this respect, the FCN program is quite distinct from FDA's regulatory oversight activities, which should continue to be supported by general tax revenues.

While funding this program through fees may become a reality in the future, it is imperative that FDA receive the necessary funding for this program in FY 2000. Industry has worked diligently to help bring about enactment of the notification program and to make it a reality through the funds appropriated last year. In turn, FDA has made preparations to implement the program at the beginning of FY 2000. We urge this Subcommittee to ensure these efforts are not wasted by making certain that the $3 million identified in FDAMA is appropriated so that FDA has adequate resources to administer the FCN program this year.

We again thank the Subcommittee for the opportunity to submit these comments on behalf of The Society of the Plastics Industry, Inc. We would be happy to answer any questions or provide information to the Subcommittee that would assist you in making these important decisions regarding the Food-Contact Notification program. Please let us know if we can be of assistance.

Sincerely,

Lewis R. Freeman, Jr.
Vice President for Government Affairs
The Society of the Plastics Industry, Inc.


1/ The Society of the Plastics Industry, Inc., is a trade association of over 2,000 members representing all segments of the plastics industry in the United States. SPI's business units and committees are composed of plastics processors, raw material suppliers, machinery manufacturers, moldmakers, and other industry-related groups and individuals. Founded in 1937, SPI serves as the "voice" of the plastics industry.

2/ P.L. 105-115, § 309; codified at 21 U.S.C. § 348(h); Federal Food, Drug, and Cosmetic Act § 409(h).

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