The Food Contact Notification Story
The story begins in 1956 and 1957 when Congress was considering the legislation that would ultimately become the Food Additives Amendment of 1958. During the legislative consideration in the 1950s, on behalf of The Society of the Plastics Industry, Inc. (SPI), Keller and Heckman LLP appeared before the House Interstate and Foreign Commerce Committee several times to urge that Congress not regulate "indirect additives," now more properly referred to as food-contact substances, under the same procedures being legislated to govern direct food additives.
Instead, Keller and Heckman advocated the enactment of a notification system and advanced a bill, H.R. 8112, for this purpose. Unfortunately, at the time, all of the focus was on chemicals added to foods and Congress ignored our pleas so that, from 1958 until 2000, to clear a food-contact substance, it was necessary to file a Food Additive Petition (FAP) and await full rulemaking action by the agency. Even though the law ordered FDA to act on such petitions within 90 days, with a possible extension of another 90 days, the fact is that the FDA took as much as five years to act on some petitions and almost none were handled in less than two years.
In 1996 and 1997, another opportunity to introduce remedial legislation finally presented itself because there was such widespread dissatisfaction with all elements of FDA's handling of FAPs. Keller and Heckman went forward then with a similar notification proposal and, happily, it was enacted in 1997. When we began, our proposal included the concept of fees to be charged for the notification process. While we were succeeding with our basic idea, some senators were philosophically opposed to FDA user fees at the time so this part of the legislation was not included in the final law.
Instead, the bill that became the Food and Drug Administration Modernization Act of 1997 (FDAMA) included the notification concept for food-contact substances, but did not call for user fees. In place of the user fee idea, it contained a rather strained and complicated provision stating that the notification program would only operate in fiscal years where at least $3,000,000 is appropriated for the program and that the budget for the Center for Food Safety and Applied Nutrition (CFSAN), equals or exceeds the amount appropriated in 1997, excluding new programs.
This budgeting provision notwithstanding, in 2000 FDA commenced the notification program, and turned it into a huge success. After the program's implementation, the agency more or less ignored the special budgeting question. Instead, the staff simply advised Keller and Heckman that the agency was including the funding in its regular budget so the money was provided.
This program has been of enormous benefit to industry because, for the most part, under it companies can file notifications that become effective in 120 days. Moreover, notifications provided companies a limited proprietary advantage over regulations and also reduce the administrative burden on FDA because no rulemakings are necessary for notifications. The issuance of effective notifications is made known on a special FDA web page. It is fair to say that industry, the agency, and everyone else concerned has been completely happy with the new program.
Now, suddenly, and not because the FDA staff is happy about it, the Department of Health and Human Services has sent to Congress a budget proposal that calls for a cessation of Food Contact Notifications (FCNs) and diversion of the funds used for this purpose to other programs relating to avian flu preparations and food security efforts. Unless the course is corrected, those who need to file for clearance of food-contact substances will be compelled to go back to filing FAPs. Since it is obvious that there will be little money for the handling of such FAPs, petitioners will undoubtedly be compelled to put up with delays of from two to five years for a clearance. In short, those who produce food-contact substances, or use them, will be sent back to the dark ages of FDA's 1950s-style regulation.
SPI is spearheading an allied-industry coalition to obtain the necessary funding to continue the FDA's FCN program in 2007. SPI's Food, Drug, and Cosmetic Packaging Materials Committee Executive Director Susan Howe has invited trade association representatives to its industry stakeholders meeting later this month. The coalition of associations will consider all options in the appropriate sequence, and final recommendations will be shared with all interested parties once they have been established.