October 25, 1999

(202) 434-4110

heckman@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

Following up on last week's letter regarding the new Food and Drug Administration (FDA) food contact substance notification program, we are enclosing copies of two letters we just received from Dr. Alan Rulis, Director of the Office of Premarket Approval at FDA. The first letter is a general communication designed to advise all of those interested in food contact substances that FDA is planning to issue its guidance documents and be fully operative as far as notification processing is concerned by January 18, 2000. This same letter has been sent to the office of The Society of the Plastics Industry, Inc. (SPI) and other trade associations. The second letter is a form communication being sent to all parties with active petitions pending recommending that they contact FDA to determine whether they "may be eligible for notification" under Section 409 (h) of the Federal Food Drug and Cosmetic Act of 1938, as amended.

The basic "game plan" that FDA is trying to enunciate through these communications can be summarized as follows:

1. The program will be fully implemented by January 18, 2000, by which time the Agency expects to have the guidance documents first circulated last Winter and then the subject of a public meeting on March 12, 1999 issued in final form. It should be presumed that by January 18^th, the Office of Premarket Approval will be adequately staffed to handle the new notification workload.

2. With respect to pending petitions, all petitioners should now consider the matter of converting them to notifications. They will be permitted to do so immediately, provided FDA and petitioners agree this would be best depending on the individual circumstances. In other words, it will be possible to convert and have the notification time.

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