SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
November 11, 1997 Newsletter

* * * For Members Only * * *

To: SPI Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentleman:

We are delighted to inform you that a final version of S.830, The Food and Drug Administration Modernization Act of 1997, which includes the statutory language to make possible a Premarket Notification (PMN) system for food contact substances, has been passed by the Senate and the House of Representatives, and is now awaiting a Presidential signature to become law. Late Sunday night, the House, by voice vote, joined the Senate (which had acted on Saturday), and passed S.830 with the language that was adopted by a joint conference committee to reconcile the differences in the House and Senate versions of the bill. It is widely expected that the President will sign the bill in the next few days.

S.830, as many of you know from our previous letters, contains the PMN system language that will supplement, and is expected to largely replace, the current food additive petition process with a simpler, faster notification system. As passed, the PMN law provides that a manufacturer or supplier of a food contact substance may submit a notification to FDA prescribing the conditions under which the substance may be safely used. Unless FDA makes a determination that the substance has not been shown to be safe, the notifying party can market the substance for food contact applications within 120 days. This clearly will be a vast improvement over the 2-to-4 years FDA often takes to approve a food additive petition.

The new system will become effective on April 1, 1999. However, as described below, the legislation provides that the PMN system will only be implemented provided that the Center for Food Safety and Nutrition (CFSAN) has been appropriated an annual amount equal to 3 million dollars for this program. The program must be reauthorized after six years.

Despite the success in getting the PMN proposal passed as part of S.830, this achievement was far from certain just a few days ago. As many of you know from our last letter, the substance of the PMN provision has always enjoyed broad support from both parties in

Congress and from FDA. However, serious differences arose during the legislative process on how best to fund the program. The original language that was introduced, which was agreed upon with FDA, provided that the PMN system would be funded by reasonable fees paid by the parties submitting notifications. This language, however, was unacceptable to several members of Congress, particularly in the House of Representatives, resulting in different versions of the bill being passed - the Senate bill contained the fee provision and the House bill contained no fee provision. FDA and its Congressional supporters were opposed to the unfunded measure becoming law, and Donna Shalala, Secretary of Health and Human Services, intimated that the bill could be vetoed if it did not contain an acceptable funding provision. At the time of our last letter, we had reason to believe that the House would concede to the Senate language and the final bill would contain the fees. But this solution never came to pass.

We then had the unenviable task of trying to find a compromise between FDA, which was advocating that the PMN system be dropped entirely unless it included fees and, on the other side, certain members of Congress who absolutely refused to pass a bill that included a call for fees of any type. Unless a compromise could be reached, we knew that the PMN system would be dropped from the bill, and we would have no chance of getting the system changed in this legislative session. During this time of uncertainty, many of you responded to our requests and used your company contacts on the Hill to let the conference committee members know how important this legislation is to your businesses. Your help was invaluable in reaching the final compromise.

After two weeks of swiftly changing negotiations, an uneasy alliance was formed and the bill was reported out of the joint conference with totally new funding language. As mentioned above, the new language provides that the PMN system will become effective on April 1, 1999. During the last six months of fiscal year 1999 (ending September 30), FDA will receive $1.5 million to fund the program; in subsequent years FDA will receive $3 million annually. Provisions are made to increase this amount if, during the course of the program, it turns out that these numbers are insufficient. The funding issue will continue to be important, however, because the final language of the bill provides that FDA does not have to implement the program unless Congress has appropriated at least the amount identified above for the program.

The text of the conference committee report and the text of the bill as reported out of the conference committee are available on the Internet at http://www.house.gov/commerce/. The legislative history that was included in the Senate Labor and Human Resources Committee Report on S.830 can be seen on our web site http://www.khlaw.com.

Our next task will be to begin working with FDA to develop the regulations that will implement the new law; to ensure that the system will be as efficient as possible while still providing the information necessary to demonstrate that the materials are safe for their intended use. As always, we will be calling for your input regarding the substance of these regulations and how they affect your particular business. After you have a chance to review the new law, if you have any questions or comments please do not hesitate to let us know.

Cordially yours,

Jerome H. Heckman

(202) 434-4110
heckman@khlaw.com

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