SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
July 30, 1998 Newsletter

* * * For Members Only * * *

1. Final Push Begins to Convince Congress to Appropriate the Necessary Funds to Implement the Food-Contact Notification Program

2. Testimony Given in Support of the FCN Program at the CFSAN Priority Meeting

3. Update on the Status of Petitions Involving Butadiene and Styrene at FDA

4. Biomaterials Liabilty Exemption Legislation Expected to Be Voted on in House; Senate Action Uncertain

5. Henney Nominated for FDA Commissioner Post; Awaits Senate Confirmation Hearing

6. CFSAN Developing System to Aid in Petition Management and Review

7. Endocrine Disruptor Report Released After Much Debate

8. European Union Considers Single Food Regulatory Agency

9. In Brief

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

Dear Ladies and Gentlemen:

A crucial time is fast approaching in our effort to obtain funding for the Food-Contact Notification (FCN) program. Both Houses of Congress have now approved separate versions of the bill that will fund FDA in 1999, and neither bill contains funds that will ensure the implementation of the notification program. We still have an opportunity to have these funds included in the final bill that will come out of conference. More detail on how you can help as well as a full discussion of our recent efforts are contained herein.

This letter also discusses several other important developments that have occurred since our last letter, including an update on the current situation at FDA regarding petitions involving butadiene and styrene. In addition, we discuss some recent progress regarding the biomaterials liability exemption legislation, interest in the EU regarding a single Community-wide food safety agency, and the recent nomination of Jane Henney for the now long-vacant FDA Commissioner post.

1. Final Push Begins to Convince Congress to Appropriate the Necessary Funds to Implement the Food-Contact Notification Program

Since our last letter to the Committee, both the House of Representatives and the Senate have passed versions of the Agriculture Appropriations Bill, which will fund the Food and Drug Administration (FDA) during the 1999 fiscal year (FY). Despite the hard work of many people here in Washington, neither bill contains language that would fully fund the newly enacted Food-Contact Notification (FCN) system¹. The Food and Drug Administration Modernization Act of 1997², Section 309 (Pub. L 105-115, 111 Stat. 2296)³. Nevertheless, we are very hopeful that, with your help, we will be able to convince Congress to include the necessary funds for the FCN program in the final appropriations bill that will be reported out of the joint conference committee after Congress' August recess. Leading up to that time in the second week of September, it is important that you show your support on this matter to your contacts in Congress. We describe how you can be of assistance later in this letter, but first we bring you up-to-date on the most recent developments.

The House of Representatives passed their version of the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bill, 1999 (H.R. 4101) on June 24, 1998. As a general matter, the funds in the bill for FDA are a little more than last year, but still are $7 million less than the Agency requested and do not include the $128 million that was requested in the Administration's budget in the form of user fees. Fortunately, the appropriation is high enough to trigger user fees for the review of new drug applications under the Prescription Drug User Fee Act (PDUFA), which was reauthorized as part of FDAMA. We had some concern that, if the funding for FDA failed to meet this trigger, our efforts to obtain money for the FCN program would be eclipsed in the ensuing battle with the drug companies over the fee plan. Even though we will not have to fight this battle, we still were not successful in getting the House to include full funding for the FCN program. What the House did include was a statement in the Committee Report that provides $500,000 for the program. Specifically, the report states:

The Food and Drug Administration Modernization Act authorized a new pre-market notification system for food packaging materials. The current lengthy review process has resulted in significant lost sales to stakeholder companies. The outdated system causes decisions to not bring new products to market. The Committee provides $500,000 to begin the development of the new approval process system.

H.Rept. 105-588. Obviously, the amount of funding is not what is identified in FDAMA, but how FDA would react to partial funding and whether the Agency would consider drafting the regulations and beginning to implement the program with these funds alone is not clear.

The Senate passed its own version of the appropriations bill on July 16, 1998 (the bill was passed as H.R. 4101 with the substituted language of S.2159 as amended). While support for the FCN program came from many Senators, no monetary figure was included in the bill or in the accompanying Committee Report. Instead, the Appropriations Subcommittee adopted an amendment offered by Senator Robert Byrd (D-WV) supporting the program. The language included in the Subcommittee report as a result of this amendment does not mention money and states simply that:

The FDA Modernization Act of 1997 (FDAMA) streamlined the regulatory process for approving food contact materials under a Premarket Notification (PMN) system. The Committee is aware of the need to implement the provision in order to spur innovative, new, and improved food packaging materials that can keep food fresher, safer, and extend its shelf life.

S. Rept. 105-212.

Even though neither of the bills contains the language that is necessary to ensure that the notification program will be implemented, they do provide a foothold toward ultimately getting the funding put in by the conference committee that will resolve the differences between the versions of the bill passed by the House and Senate. In fact, several people familiar with the budget process advise that, in their opinion, obtaining an appropriation for such a small amount of funds in this contentious year would only happen in the conference committee, if at all; so we are still optimistic that the funds will be appropriated.

Our efforts are now focused on this last chance to secure the funding for the program. To set the appropriate stage for negotiations and to provide a record that would support appropriating these funds in the final version of the bill, three Senators have submitted colloquies that were included in the Congressional Record. These mock conversations express the Senators' interest in the notification program and the importance of the funds. The first colloquy, between Senator Orrin Hatch (R-UT) and Senator Thad Cochran (R-MS), Chairman of the Appropriations Subcommittee, appeared in the Congressional Record on July 15, 1998 (Congressional Record, S8236). The second colloquy was between Mr. Cochran and Senator Tom Harkin (D-IA) it published on July 16, 1998 (Congressional Record, S8315). The text of both the colloquies is attached to this letter.

The Senate has already appointed its representatives to the Conference Committee. The appointees consist largely of the Agriculture Appropriations Subcommittee and a few members of the full Appropriations Committee. The Senate conferees are Senators Cochran, Specter, Bond, Gorton, McConnell, Burns, Stevens, Bumpers, Harkin, Leahy, Boxer, and Byrd. The House has not appointed its representatives. It now appears that the conferees will not meet before the August recess. The Senate is scheduled to adjourn later this week and the House will follow on August 10. Both Houses will return to work during the second week in September.

Even though Congress will be in recess, we expect that the Congressional staff will meet during the break to begin working out the differences between the two bills. Therefore, it is still important that they have support from your companies during the coming month. If you have not done so already, please contact the Members of the Conference Committee that represent your company or with whom you have any sort of other relationship. While the House has not formally named the members of the Conference Committee, traditionally, the appointees are the Members of the Appropriations Subcommittee, and we have no reason to think that this year will be otherwise. The phone and fax numbers for the Senate conferees and the likely appointees from the House are attached to this letter. It also would be beneficial for you to contact any other members of Congress with whom your company may have a connection so they can approach their colleagues to urge that these funds be appropriated. The message you should communicate is that "while we do appreciate the efforts that already have been made by Members in the House to secure $500,000 for the program and the efforts on the part of the Senate Subcommittee Members to state their support for implementing the program, we are afraid that FDA will choose not to implement the program unless the full $1.5 million that is called for in the Food and Drug Administration Modernization Act (FDAMA) is actually appropriated." If the Agency does not receive full funding, all of our efforts to achieve a simpler, more efficient regulatory program food packaging could be for nought.

If you should have any questions about how to proceed, or if we can assist you in making these contacts in any way, please let us know by telephone, fax, or e-mail so that we may respond to you as quickly as possible. As you do make contacts, preferably by phone calls, faxes and letters, in that order, it would be very helpful if you could inform us about them so we can let the Washington group of company representatives know where efforts have been made and might potentially be reinforced.

2. Testimony Given in Support of the FCN Program at the CFSAN Priority Meeting

In addition to our legislative push to obtain funds to implement the FCN program, we are also trying to persuade the Agency that a small investment in promulgating regulations and implementing the notification program will result in a savings of resources which the Agency can then devote to other programs. As part of this effort, Tom Brown (former acting head of the Indirect Additives Division at FDA and now a staff scientist at Keller and Heckman) and I testified at a meeting held by the Center for Food Safety and Applied Nutrition (CFSAN) on June 24 and 25. This meeting was called by the Center's new director, Mr. Joe Levitt, to solicit comment from interested parties as to what the Center's priorities should be in the coming year. In the Federal Register notice announcing this meeting and at the meeting itself, Mr. Levitt emphasized that the Center did not have the resources to accomplish all the responsibilities that it has been assigned in a reasonable time period. 63 Fed. Reg. 30242 (June 3, 1998. In addition, President Clinton has directed that the Center's first and foremost priority must be the implementation of the Food Safety Initiative (FSI). Thus, the Center is conducting a comprehensive review of all its programs to establish priorities and reasonable work expectations for the coming year. As part of this review, the Center held the June meeting to seek input from the public as to what the Center's priorities should be considering that the implementation of the FSI will be the primary focus.

Our testimony before the Center focused on the benefits of implementing the FCN program. We told the panel that the food-packaging industry is working diligently to obtain funds from Congress for the program and still is willing to pay fees for notifications if Congress chooses to authorize such fees in the future. Tom Brown's testimony focused on the savings in time and money that the Center could realize by implementing the program. He suggested that the Center consider a pilot study of the FCN program to measure its impact on Center resources. He added that the pilot study could be implemented without any real disruption in the current petition review process and review times could be closed tracked. A full copy of our comments was filed in the FDA Docket. Please let us know if you would like to receive a copy of our comments.

Other groups that testified at the meeting were the Independent Cosmetic Manufacturers and Distributors, the American Frozen Food Institute, the National Food Processors Association, the Grocery Manufacturers Association and the Center for Science in the Public Interest.

3. Update on the Status of Petitions Involving Butadiene and Styrene at FDA

As many of you know, for several years FDA has suspended its review of indirect additive petitions involving butadiene pending the completion of a safety evaluation by the Agency's Quantitative Risk Assessment Committee (QRAC). In response to an FDA's request, the FDCPMC Butadiene Task Group supplied exposure data to the Agency. We were recently notified that the Executive Secretary of FDA's Cancer Assessment Committee (CAC), Dr. Karen Ekelman, has completed a draft memorandum on butadiene which will be forwarded to Dr. Ron Lorentzen, the head of FDA's Quantitative Risk Assessment Committee (QRAC). With the draft memorandum under review by QRAC, a virtually safe dose (VSD)⁴ for butadiene may be assigned by September 1998. In the meantime, we expect that FDA is likely to act on some of the pending petitions involving butadiene, as it should be confident that the VSD will be high enough to cover all of the exposures of interest.

Unfortunately, however, pending petitions that involve both butadiene and styrene constituents may now be further delayed because the Agency recently decided to suspend action on petitions that involve styrene monomers and polymers. We were informed that an FDA staff member, who has subsequently left the Agency, completed an extensive review of all of the available toxicology data on styrene and prepared a memorandum recommending that FDA make a decision as to whether styrene is a carcinogen and assign a VSD⁵.

We understand that the Agency's evaluation of the possible carcinogenic aspects of styrene is proceeding along two paths. First, an outside contractor will review twenty (20) selected epidemiology studies on styrene. This process is expected to take at least one year. Once the contractor's work is completed, CAC will probably take an additional 6 to 12 months to review the results, and, if styrene is deemed a carcinogen, for QRAC to assign a VSD. Second, FDA is working to assign a "temporary worst case" VSD to styrene. In this regard, the Agency is continuing work on the draft memorandum noted above, and, more specifically, is determining a unit risk for styrene based on the "worst case" animal study results available and typical "worst case" assumptions, including an assumption that styrene is a carcinogen. The final memorandum will be presented to CAC for sign-off only, and not for full CAC review.

FDA staff chemists have indicated that nearly all of the pending petitions involving styrene as a constituent (in fact, all but two or three of the petitions) will be acceptable under the projected VSD, but acting on the remaining petitions, specifically the older petitions employing less sensitive analytical methodology for exposure data, may continue to be suspended until the Agency makes a final decision as to whether styrene is, in fact, a carcinogen. For these petitions, we expect that FDA will be willing to provide petitioners with an opportunity to submit additional migration data to satisfy the parameters of the designated unit risk.

In light of the number of pending petitions that are impacted by this situation, we understand that the styrene matter is a "medium-high priority" for the Agency and that, consequently, project funding and personnel have been specifically designated to ensure that the work associated with this matter will be done in a timely manner.