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 SPI
- Food, Drug, and * * * For Members Only * * * Table of Contents
The Society of the
Plastics Industry, Inc. Dear Ladies and Gentlemen: In this letter, we report on the latest language in the appropriation bill for the Food and Drug Administration's (FDA's) budget that will fund the new Food Contact Notification (FCN) program. As we describe more fully below, while the current language in the bill could postpone the program's implementation for a few months, it does earmark funds for the program, and we have been assured by FDA that the Agency has been working on draft regulations which could be released before the end of the year. The President initially vetoed the Agriculture Appropriations bill that contained this language, but we are hopeful that the same provision will be included in the budget ultimately worked out by Congress and the Administration. We also are happy to report that the jurisdictional problems between FDA and the Environmental Protection Agency (EPA) over antimicrobials which resulted in the Food Quality Protection Act (FQPA) have been generally resolved by a technical correction in the law which passed the Congress last week. This correction returns the jurisdiction of antimicrobials in most food-contact materials to FDA, allowing the Agency to work on a number of petitions that have been on hold for some time. Finally, we discuss the status of the nomination of Dr. Jane Henney as FDA commissioner, the publication of the final Endocrine Disruptor Testing Advisory Committee (EDSTAC) report, and the changes in some of the top leadership at EPA, as well as some other matters of interest to the Committee. 1. Congress Approves New Language to Fund the Food Contact Notification Program After several months of work, a resolution may finally have been reached over the funding that will be included in FDA's 1999 budget to implement the Food Contact Notification (FCN) program. You will recall that the funding bill had been caught in the fight over the overall federal budget. As most of you I am sure are aware, the situation regarding passage of the federal budget this year has been highly charged, with each party trying to jockey for the best political position before the November elections. Congress had approved a version of the fiscal year (FY) 1999 agriculture appropriations bill (H.R. 4101) that would have funded FDA during the coming year. The bill was vetoed by the President on October 8 because the administration felt that the level of aid in the bill for farmers was insufficient. After subsequent deliberation, Congress and the White House reached an accord on the budget on October 15, and agreed to an omnibus spending bill, which will wrap all the remaining appropriations bills into a single, enormous piece of legislation. This bill is currently scheduled for a vote in both the House and Senate on Tuesday, October 20. In the agreement reached between Congress and the White House, nearly $6 billion in additional aid to farmers was included, hopefully putting this issue to rest. Both Chambers are considering the same version of the omnibus spending bill; therefore, if passed without amendment, the bill would be sent directly to the President for his signature. We understand that the agriculture appropriations bill will be included in the omnibus spending legislation. Although language in the bill regarding aid to farmers has been altered, we do not expect that the language regarding the FCN program will be changed when the agriculture appropriations bill is added to the omnibus bill; however, the complete text of the bill is not yet available. We will update you on the status of the FCN funding provision as soon as the omnibus spending bill is released to the public. The specific language for the FCN program in the previous agriculture appropriations bill that was vetoed by the President included $500,000 for the program. The specific language is different from that reported to you in our last letter and different from the language originally passed by the House. However, after consultation with FDA, the Conference Committee decided on the following clause that will likely now be part of the agriculture appropriations to be included in the omnibus spending package: . . . an amount of $500,000 shall be made available for the development of systems, regulations, and pilot programs, if any, that would be required to permit full implementation, consistent with section 409(h)(5) of that Act, in fiscal year 2000 of the food contact substance notification program under Section 409(h) of such Act;This language falls short of mandating FDA to implement the program as promptly as FDAMA provided, because the new language postpones the full implementation of the program from April 1, 1999 to fiscal year 2000, which starts on October 1, 1999. From conversations with our contacts at FDA, we learned that FDA currently intends to implement the program in the Fall of 1999, provided, of course, that they obtain additional funding for the program next year. We assured our contacts at FDA that we will continue to do our best to obtain sufficient appropriations for the program and to work out a permanent solution to this vexing funding issue. We also learned that FDA has indeed been working on regulations and related documents for implementing the FCN program, relying in part on the draft regulations that we provided in May. Our sources now indicate that proposed regulations should be published by December of this year. FDA also may start pilot programs for the FCN program before October 1, 1999.
2. Congress Passes Technical Correction for FQPA that Returns the Regulation of Most Antimicrobials to FDA Congress has finally passed a technical correction that will resolve some of the jurisdictional conflicts between EPA and FDA created by the Food Quality Protection Act of 1996 (FQPA). In previous letters we described the problems raised by FQPA and our efforts toward obtaining a resolution. The bill, H.R. 4679, which is now awaiting the President's signature, returns to FDA much of the jurisdiction it exercised before FQPA with regard to antimicrobials in food packaging and other food-contact materials. It also codifies the informal practice followed by FDA prior to FQPA with regard to the use of antimicrobials on raw agricultural commodities (RACs) in food processing establishments. In addition, the correction establishes that ethylene oxide and propylene oxide are unambiguously subject to EPA jurisdiction when applied to food regardless of the purpose of such application and regardless of whether the food is a RAC or a processed food. The new law immediately restores FDA's authority to review a number of food additive petitions which have been on hold since August of 1996. Unfortunately, however, this law does not solve all of the complications regarding the regulation of antimicrobials in or on food and food-contact substances created by FQPA. Specifically, it does not amend the definition of "pesticide" (except arguably to make it more inclusive with respect to ethylene and propylene oxides). As a result, even though jurisdictional responsibility will be restored to FDA for the safety of many antimicrobial residues in food, EPA still will be required to register the products as pesticides for such use. In addition to the legislative fix, EPA and FDA reportedly have reached an agreement on an amendment to EPA's pesticide regulation that has been anticipated for more than a year. At this time, however, it is not clear whether the legislative action will encourage the agencies to move forward with this rulemaking or cause them to lose interest. The anticipated regulatory amendments would modify the definition of "pest" to expand the exclusion for microorganisms in or on foods and food packaging, and would have the effect of superseding all of the provisions in the technical corrections bill except for the classification of ethylene oxide and propylene oxide. Assuming H.R. 4679 becomes law and the regulatory definition of pest is not amended by regulation, an interesting discrepancy between Sections 408 and 409 of the Federal Food Drug and Cosmetic Act could arise. As discussed above, FDA would have responsibility for issuing food additive regulations, including Threshold of Regulation submissions, GRAS notifications, and food-contact notifications, when available, which accomplish the legal effect of preventing residual levels of antimicrobials from causing food to be adulterated. The criteria for issuing such regulations are contained in Section 409 of the Act, which includes the Delaney Clause prohibition on approving substances shown to cause cancer by ingestion. Even after appropriate clearances have been established with FDA, however, EPA still must register the product as a pesticide. Moreover, EPA may not approve a pesticide that presents unreasonable adverse effects on the environment. A human dietary risk for pesticide residues in or on any food that is inconsistent with the standard under Section 408 of the Act is automatically an unreasonable adverse effect on the environment. Under Section 408, there is no Delaney Clause, but there is a need for EPA to consider exposure from non-dietary sources (except occupational) and to consider the need for additional safety factors to protect children. Thus, it is possible that FDA, completely in accord with Section 409, could issue a food additive regulation for residues of a pesticide that EPA, completely in accord with Section 408, would be prohibited from registering for use as a pesticide. Thus, the rulemaking that EPA and FDA have been discussing to amend the definition of "pest" to exclude microorganisms from the definition when they are on food packaging must be completed in order to fully correct the complications inadvertently created by FQPA.
3. Henney Nomination Reported Out of Labor Committee but Stalled on Senate Floor On September 23, the Senate Labor Committee reported to the full Senate the nomination of Dr. Jane Henney to fill the vacant FDA Commissioner position. The vote came after heavy scrutiny of Dr. Henney's past record at FDA by certain members of the Committee. Although Dr. Henney's nomination has been placed on the Senate calendar for a floor vote, Senator Don Nickles (R-Ok.) has put a hold on the Henney nomination, which will most likely prevent the nomination from being voted on before the Senate adjourns. A Nickles spokesperson stated that Nickles, along with other Senators who have not yet been identified, are upset about Dr. Henney's earlier role at FDA. Some believe that Dr. Henney has a history of regulating matters at FDA beyond what Congress is willing to authorize, specifically regarding her previous work on the regulation of tobacco and the abortion pill, RU-486.
4. CFSAN Sets Program Priorities for 1999 and Beyond As we reported previously, on June 24 and 25, the Center for Food Safety and Applied Nutrition (CFSAN) held a public meeting to discuss the creation of program priorities. You may recall that Jerry Heckman and Tom Brown (now with our firm, but formerly head of FDA's Indirect Additives Branch in the Office of Premarket Approval) testified at the public meeting regarding the importance of fully funding and implementing the Food-Contact Notification (FCN) system. In a September 23 letter to the program's participants that summarized the themes of the public meeting, Dr. Joe Levitt, CFSAN Director, indicated that oral comments were received from 38 individuals representing 23 different organizations, including consumer groups, industry associations, and health professional associations. Dr. Levitt stated that four priority areas were most commonly identified by those giving input to the Center. The Food Safety Initiative (FSI) was identified by most to be CFSAN's top priority. Second was the need to reform the Center's food additive approval process to reduce the backlog of pending petitions and to increase the timeliness of high quality petition reviews. The third and fourth priorities were international harmonization, specifically in the development of international food safety standards by the Codex Alimentarius Commission, and the need for the Center's science base to be maintained at the highest level to ensure that regulatory decisions have the necessary scientific foundation. We are encouraged by Dr. Levitt's comments that the Center will make reducing the processing and review of food additive petitions a priority, and we hope that FDA views the FCN program as an important step toward achieving this goal.
Many of you may recall the discussion in our previous letters regarding the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), which has now issued a report setting out a plan that could cost industry millions of dollars to evaluate thousands of commercial pesticides and industrial chemicals for their potential to disrupt the hormone systems in humans and animals. EDSTAC was convened by EPA in 1996 to advise the Agency on how it should comply with Congressional mandates in the 1996 drinking water and pesticide safety laws. On October 5, EDSTAC presented the final report to EPA and released the document to the public. The report estimates that 87,000 chemicals need to be evaluated, including pesticides, commodity chemicals, naturally occurring estrogens (from plant and fungi sources), food additives, cosmetics, and nutritional supplements. Lynn Goldman, head of the Office of Prevention, Pesticides, and Toxic Substances at EPA and Chairperson of EDSTAC, stated recently that EPA plans to issue a public notice in November that will further explain how the Agency plans to implement the EDSTAC report. The EDSTAC report is scheduled to be reviewed in March 1999 by a special committee of EPA's Science Advisory Board. After this review, EPA will attempt to standardize and validate the recommended screening and testing methods. The testing will be costly, and there has been no determination of who will pay for it. In addition, there is concern that requiring such testing may create a barrier to international trade. A major issue is that none of the recommended tests have been validated, although a validation program is scheduled.
6. High-Ranking Officials Leaving EPA Carol Browner, Administrator of EPA, has announced that she will be leaving the Agency eventually to head up Vice President Gore's presidential campaign. Fred Hansen, Deputy Administrator at EPA, announced that he will be leaving the Agency in October to become head of Tri-Met, the regional public transportation authority in Portland, Oregon. Lynn Goldman, EPA's Assistant Administrator for Prevention, Pesticides, and Toxic Substances, also announced that she will be leaving the Agency by the end of the year. Recently, Goldman has been heavily involved with the implementation of the Food Quality Protection Act. Finally, Bill Jordan, who has been in charge of the antimicrobial division, will be changing jobs at EPA to become involved in the Agency's tolerance reassessment activities.
7. Collins Hearings Raise Issue of Civil Penalty Authority for FDA During the recent food safety hearings, Senator Susan Collins (R-Maine), Chairperson of the Senate Governmental Affairs Permanent Subcommittee on Investigations, raised the issue of possible legislation to give FDA civil penalty authority. The Collins hearings, as they have come to be called, began in May with a review of a General Accounting Office (GAO) report on the safety of imported food and in subsequent sessions have addressed foodborne illness issues, including the Guatemalan raspberries situation, proposals for imported food equivalency agreements between the United States and other countries, and problems with FDA's current imported food inspection system. The issue of granting FDA the authority to impose civil penalties, while mentioned in the context of imported food, could have a significant effect on all FDA-regulated industries because of the real possibility that FDA would move from a "health and safety" focus to an "enforcement" focus because of the allure of obtaining additional funds through fines. As many of you know, this issue was raised in legislation last year that was quashed, largely because of industry opposition.
As always, if you have any questions or comments about any of the issues discussed in this letter, we would be pleased to hear from you. Cordially yours, Ralph A. Simmons (202) 434-4120
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 © Copyright 2005 The Society of the Plastics Industry.
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