FDA Hosts Stakeholders Workshop on FCN Process

Date: Dec 01, 2002

The Food and Drug Administration (FDA) hosted a workshop October 15 to review ways to make the Food Contact Notification (FCN) system more efficient, and it heard suggestions for improvements from industry reps.

Timing issues dominate the industry's concerns about the FCN process. FDA's two-part review process begins with receipt of the FCN, starting the 120-day clock in motion as the notification is forwarded to reviewers who assess toxicology, chemistry, and environmental impacts of the food contact substance. If FDA accepts the FCN after this "phase-I" review, FDA sends an acknowledgement letter, and the notification moves to phase-II. If not, the notifier receives a deficiency letter and can either withdraw the notification or respond to the deficiency. If the response cures the deficiency, the notification moves to phase-II review.

The wrinkle is FDA may reset the 120-day clock, depending on the nature and amount of extra information in the response, delaying final action.

Late notice to the notifier by FDA of questions after the phase-I review -and inconsistencies in setting deadlines for notifiers to respond to FDA requests for additional information - create difficulties, especially if upstream suppliers or third-party laboratories must provide the requested data in a short time.

In addition to incorporating a ten-day response time into its FCN Administrative Guidance, workshop participants suggested FDA adopt a consistent policy of sending deficiency notices electronically (via fax and/or e-mail), not simply by mail.

Also criticized were situations in which FDA has disclosed data marked "confidential" in an FCN. FDA should provide notice to the affected party prior to releasing trade-secret information. FDA representatives said FDA is not bound to provide notice if it determines data is not confidential. There is disagreement regarding the legal basis for this position.

FDA pointed out some common administrative and other deficiencies in FCNs, including deficiencies in presenting chemical, toxicological, and environmental assessment information. Topping the list on the administrative end were forms completed improperly, failure to organize the FCN properly, and failure to provide the requisite number of copies (or providing illegible copies).

Some FCNs lack proper chemistry information, e.g., identifying a substance by trade name, rather than by CAS name, IUPAC name, or common name, or failing to ensure the substance's structure matches the name. Impurities must be listed, along with specifications, including purity, residuals, analytical methods, and data. A complete description of use is required, including levels, food types, and temperatures, plus data on the technical effect of the substance. Where appropriate, detailed migration testing information "making sure that test conditions match the intended use" is essential.

FDA noted failures to submit exposure estimates and to summarize properly, concisely, and completely the scientific basis for a safety decision based on that exposure estimate. Also, notifiers at times fail to calculate EDIs (estimated daily intake) correctly. Notifiers seeking to justify alternative approaches to estimating risk must provide a convincing scientific case, looking at all available toxicological data. Again, organizing safety data properly can be effective.

FCNs must contain either an environmental assessment (EA) or a claim of categorical exclusion from the need to prepare an EA. FCNs will be rejected if the environmental component is missing or deficient.

Environmental deficiencies range from failing to address environmental aspects at all, to citing the wrong categorical exclusion, to failing to discuss the potential impact on solid-waste strategies.

The FCN process offers a faster way for companies to make safe, new food-contact packaging products available to the public. Hopefully, business and FDA can work together to resolve issues and improve efficiencies so these objectives are met fully.

Reproduced with the permission of Paper, Film & Foil CONVERTER magazine (312.726.2802). Copyright © 2002 by Intertec Publishing. All rights reserved.

Sheila A. Millar, a partner with Keller and Heckman LLP, counsels both corporate and association clients. Contact her at 202/434-4143; millar@khlaw.com; PackagingLaw.com.