COMMENTS OF DR. DONALD NARAGON
Chairman
The Society of the Plastics Industry, Inc. (SPI)
Food, Drug, and Cosmetic Packaging Materials Committee

Prepared for Presentation

At the Food and Drug Administration's Stakeholders
Meeting on Premarket Notification

March 12, 1999
Bethesda, Maryland

Good Morning.

I am Dr. Don Naragon, a senior scientist with Bayer Corporation in Pittsburgh, Pennsylvania. Bayer is a research-based company with major businesses in health care, life sciences and chemicals and employees over 26,000 people. Bayer Corp. is a member of the worldwide Bayer group that is based in Leverkusen, Germany. I am a member of Bayer Corp.'s regulatory affairs group with responsibility for food-contact compliance topics for the Pittsburgh-based chemicals divisions.

However, today I come before you as Chairman of the Food, Drug, and Cosmetics Packaging Materials Committee (FDCPMC) of the Society of the Plastics Industry, Inc. (SPI). The SPI is a national trade association of the plastics industry with over 2,000 member companies nationwide. SPI represents every facet of this industry: manufacturers of plastics, raw materials, products, machinery and molds. About 100 of these member companies are members of the FDCPMC.

The mission of the FDCPMC is, in part, to foster the use of good science and good public policy in the regulation of the food, drug and cosmetics packaging and other plastic food contact applications. As an objective, SPI'' FDCPMC seeks and encourages the use of good science, reasonableness, and uniformity in regulatory matters and laws affecting the plastics food, drug and cosmetic packaging industry.

Today, I would like to thank the Food and Drug Administration for holding this stakeholder workshop. We look forward to working with the FDA and are very heartened by the excellent work that has been done by the FDA staff on the Draft Administrative document, Draft Toxicological document, and the Draft Chemistry document. In general, the drafts are fair, reasonable and a good start in the implementation of the FCN process.

A major focus of the Food Safety Initiative is the reduction in illness caused by food-borne pathogens. The FDA Premarket Notification program is expected to play a role in reducing food-borne pathogens and keeping foods fresher, longer, by encouraging development of new packaging and new food handling techniques.

Under the current system, a major negative disincentive has been the length of time required from the submission of a food additive petition until the completion of an evaluation of the petition by the FDA. This very lengthy process inhibits new products and new applications of currently permitted products; and, inhibits approach and discussion with the FDA in those cases where it is not a legal requirement to obtain a clearance from FDA.

The FDA Premarket Notification program will encourage the development of new products and new uses of currently complying materials. It will also encourage more communication with FDA on food contact products in the market place. To be of the most value, the FDA must adhere to the 120-day review time frame. With the submitter specific provisions of the Premarket Notification program, reasonable notification costs and filing fees are expected, and SPI supports reasonable fees. In the Federal Register notice, it was noted that one of the four copies required for a submission of a Premarket Notification may be provided electronically. SPI would like to encourage the Agency to permit those who wish to do so, to submit the notification solely by electronic means.

Packaging suppliers must document the safety and FDA compliance of their products to their customers. We are pleased to see the acknowledgement of a receipt of a Premarket Notification within 30 days has been included in the Administration Draft document. However, to promote the widest use of the FDA Premarket Notification program, a "standard operating procedure" is needed to notify the submitter that the review period has successfully closed, and the notification has become effective. We also believe it is important for the FDA to state, as noted in the Administrative and Chemistry documents, when a Premarket Notification is not required and will not be accepted by the FDA. This concept and reference is needed for customer assurance by the regulated community.

In conclusion, the FDCPMC looks forward to continuing to work with the FDA on the implementation of the Premarket Notification program. And, as stated at the beginning of these comments, the FDCPMC is very encouraged by the work that has been done by the staff in drafting the three information documents. On behalf of the SPI's FDCPMC - Thank You.

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