Will Congress Pay For Faster FDA Clearance of Packaging Materials?

George Misko, Partner, Keller & Heckman

As you may recall, the Food and Drug Administration Modernization Act of 1997 (FDAMA), enacted into law this past Fall, includes a new pre-market notification system for food-contact substances that may drastically reduce the time and resources involved in obtaining FDA clearance for the use of some packaging materials. (See Regulatory Update, January 1998.)

The law is scheduled to go into effect in April, 1999; however, there's a catch: Congress must appropriate sufficient funds to FDA to run the program.

Show Me The Money

When the legislation was introduced in Congress, industry had agreed with FDA to pay reasonable fees to fund the program. But, because of opposition to user fees by some in Congress, the law was changed so that the system would be paid for from FDA's general funds, with Congress to provide a special appropriation to avoid diversion of other Agency resources.

Unfortunately, the appropriation for the 'Food-Contact Notification' (FCN) system was not included in the President's budget, which was sent to Congress on February 2, 1998. While FDA requested the Administration to include funding for the FCN system in its budget, this item, along with other requests, was cut by the Office of Management and Budget (OMB), which - totally ignoring Congress's previous rejection of user fees - suggested that this is exactly how the system should be funded.

Strictly speaking, FDA would still be required to start the program, even if no money is appropriated, provided that the overall funding for the Center for Food Safety and Applied Nutrition (CFSAN) meets a certain level. This twist arises from the funding provision in FDAMA, which states that the FCN program shall not operate unless Congress has appropriated $1.5 million in 1999 ($3 million in the fiscal years thereafter), or the amount specified in the President's budget request, whichever is less.

Since the Presiden's budget request of nothing is less than $1.5 million, FDA will be required to implement the system, even if no further funds are appropriated.

Of course, Agency officials will not be happy about having to do this without additional funds, and such a lack of funding will buttress the arguments of some within FDA who already want to limit severely the application of the program, making it the exception, rather than the rule, for FDA clearance of food-contact substances. Thus, we should make every effort to find the appropriate funding.

Add Your Voice

If money is to be appropriated, it must come at Congress's own direction, and that is not likely to happen unless Congressional representatives hear from their constituents in the packaging industry on how important it is to find proper funding.

Several companies and allied trade associations - such as The Society of the Plastics Industry, the Can Manufacturers Institute, the American Forest and Paper Association, the Flexible Packaging Association and the Adhesive Manufacturers Association-are working together to garner support on Capitol Hill for full funding of the provision, but they need your help to succeed.

In the next few weeks, the Appropriations Committees will decide what FDA programs to fund. The success of achieving funding for the FCN system will largely depend on a strong showing of support by the constituents of committee members and others.

Urge your Congressmen to include funds for the FCN system. Call us if you would like more information on how to reach your representatives.

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