FDA Cuts Deadwood Proposals, but Keeps the Roots

Date: Jun 01, 2003

The U.S. Food and Drug Administration (FDA) wants to withdraw 84 proposed actions and rules that were never made final, and which it considers no longer to be priorities. The Agency's action - part of the regulatory reform strategy initiated by Health and Human Services Secretary, Tommy Thompson - represents an effort to clarify the status of old projects, simplify and streamline the rulemaking process and focus efforts on relevant pending projects.

But the effort could result in some confusion. FDA is trying to hold on to several of the policy statements underlying the proposed actions that it is now ready to jettison- except the Agency has not identified which statements it will retain.

The proposals marked for withdrawal cover almost every program area administered by FDA, including food, drugs (human and animal) and even cosmetics. The vast majority are related to food or food-contact materials. The Agency wants to withdraw 30 proposals dealing with food products, many of which concern labeling issues, 18 proposals to affirm specified ingredients as "generally recognized as safe" (GRAS) for use in food or food-contact materials and four proposals dealing with substances used in food packaging or products otherwise intended to contact food.

All of the projects marked for withdrawal date back at least five years and, in some cases, a quarter century! In many cases, FDA says that it has carried out alternative measures in related regulations that obviate the need for the proposal. Other proposals are simply no longer priorities, given the Agency's need to focus its resources on more critical responsibilities. Finally, some proposals rely on methods and approaches that, given the amount of time that has elapsed, are no longer appropriate.

Of particular interest to packaging people is the FDA's intent to withdraw its proposals on the following:
    • Advanced Notice of Proposed Rulemaking on Acrylonitrile Copolymers Intended for Use in Contact with Food (Docket No. 77N-0078, published in the Federal Register, March 11, 1977).

    • Proposed Maximum Residue Limits and Maximum Daily Levels of Exposure for Ethylene Oxide, Ethylene Chlorohydrin and Ethylene Glycol (Docket No. 77N-0424, published in the Federal Register, June 23, 1978).

    • Proposal to Permit the Use of Vinyl Chloride Polymers in Food Packaging (Docket No. 84N-0334, published in the Federal Register, Feb. 3, 1986).

The effect of the withdrawal is not always clear. In particular, the Agency advises that, in some cases, the preambles of the targeted proposals "may still reflect the current position of FDA on the matter addressed." Further, "withdrawal of a proposal is not intended to affect whatever utility the preamble statements may currently have as indications of FDA's position on a matter at the time the proposal was published."

Also, withdrawals of rulemakings dealing with GRAS substances should not be viewed rejecting the conclusion that the subject substance is GRAS. Substances can be sold for use in food or food packaging as GRAS without any prior approval or clearance from FDA.

The GRAS affirmation process (and its successor, the GRAS notification process) is intended only as a mechanism to seek FDA's input on the determinationit is a strictly voluntary procedure. Thus, FDA's withdrawal of a proposal is not an indication that it has determined the substance not to be GRAS, but on the contrary, that the Agency just does not need to consider the matter further.

Comments from the public on the initiative in general, and on the withdrawal of specific proposals in particular, will be accepted by the Agency until July 21. A list of each of the proposed rules to be withdrawn was published in the April 22 Federal Register.

Used with permission. Copyright FOOD & DRUG PACKAGING, June, 2003.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.