April 6, 1999
(202) 434-4110
heckman@khlaw.com

The Society of the Plastics Industry, Inc.
Food, Drug, and Cosmetic Packaging Materials Committee

Re: Comments on the Implementation of the Premarket Notification Program for Food-Contact Substances;
Our File No. SP08253-001

Dear Ladies and Gentlemen:

Enclosed with this letter is a copy of the comments that we filed with the Food and Drug Administration (FDA) on behalf of The Society of the Plastics Industry, Inc.'s, (SPI) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) regarding the implementation of the premarket notification (PMN) program for food-contact substances. (FDA's Docket No. 99N-0235 ("Premarket Notification for Food Contact Substances"). These comments address the issues raised by FDA in its Federal Register notice announcing the March 12, 1999 stakeholders meeting and the three draft guidance documents that the Agency released shortly before the meeting.¹ In addition, the comments supplement the presentations made by Dr. Don Naragon, Chairman of the FDCPMC, Dr. Lester Borodinsky, Technical Advisor to the FDCPMC, and myself at the stakeholders meeting.

While we tried to address most of the major issues that we thought were of concern to the Committee in the comments that were submitted last Friday, we realize that we may not have included everything all of us wanted to say. The reason why we did not solicit input from the full Committee before the comments were filed is because FDA, unfortunately, provided a very short comment period between the publication of the Federal Register notice and the March 22, 1999 deadline. Although FDA officials stated that they would keep the comment period open for a short time after the published cutoff date, we did not want too much time to elapse after the meeting before submitting our comments. Even so, there will be ample additional opportunities to put further ideas forth since the current state of the Docket is such that FDA cannot really do anything final without proposing more formal regulations and perhaps additional guidance documents. When it takes this step, it must also provide another opportunity for comment under the basic procedural regulations that bind it.

The comments that we submitted Friday on behalf of SPI did reflect the input of the members of the Legislative and PMN Working Group Committees that attended a March 24, 1999 meeting at SPI to discuss the pertinent issues. An e-mail draft of the final comments was then provided to those who attended that meeting. Some of the issues raised at the meeting are not covered in Friday's submission. This is because it was agreed that there should be more time to explore any innovative ideas more fully and to discuss such points with the entire Committee to determine what each of you believe would be most desirable. For example, one of the issues raised was the concept of seeking a data compensation system for toxicology studies similar to the one that some of you may be familiar with under the pesticides law (the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)). Under this proposal, notifiers would have to pay compensation to a company that performed a study if they relied upon the data to demonstrate the safety of their food-contact substance in a food-contact notification. Currently, submitters of food additive petitions, which of course are not proprietary, can rely on studies performed by other manufactures without having to pay compensation for the data. Obviously, such a system would cut both ways, so we will look forward to hearing from you as to whether such a system would be advantageous. With the anticipated new requirements for genotox data to be filed in some food-contact substance notifications, this could be a matter of interest and consequence. We have raised this issue informally with FDA, and will share any reaction we get after Dr. Mitchell Cheeseman, who is heading up the implementation of the PMN program, has had a chance to think it over and discuss it internally at the Agency.

We do hope you find the comments generally in order and in keeping with the objectives of the Committee. Please, however, do give us your reactions, further comments, and any questions that occur to you.

Sincerely yours,

Jerome H. Heckman

Comments on the Implementation of the Premarket Notification Premarket Notification for Food-Contact Substances [Docket No. 99N-0235]

¹64 Fed. Reg. 8577 (February 22, 1999). Copies of the draft guidance documents for chemistry, toxicology, and administrative information for implementation of the PMN program are available on FDA's website and Keller and Heckman's website.