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 October 22, 1999 (202) 434-4110 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: Our main focus of this letter is to provide you with an update on the current state of appropriations for the Food and Drug Administration’s (FDA) Food Contact Notification Program and a discussion of FDA’s plans for implementing the program once the President signs off on the Bill. In addition, we are bringing you up-to-date on California’s deposit bill, news relating to the Food Irradiation Coalition’s petition for irradiation of ready-to-eat foods, and other matters of interest to the Committee. Table of Contents
The Senate and House of Representatives have now passed their versions of the Agriculture Appropriations Bill, including $6 million in appropriations for the FDA’s Food Contact Notification (FCN) program. Thus, Congressional action is complete, and the bill now awaits signature by the President. Some of you have expressed concern with the delay in signature by the president. There is some speculation on the Hill that the President simply is not signing any appropriation bills until he has settled with Congress over the ones that are very controversial. (See your local paper for details on this debate.) To the best of our knowledge, the Agriculture Appropriations Bill is not controversial and, more importantly, contains provisions for farm relief, etc. that the President strongly supports. In short, we do expect him to sign in the near future. Once the President signs off on the bill, we expect FDA to send us a letter indicating its intent to accept notifications (instead of petitions) quite promptly. However, it likely will urge those who wish to file to talk with the Agency before doing so. This is the mechanism we believe FDA will use pending publication within a couple of months of revised Guidances on how the system will work, what will be required, etc. In short, once the bill is signed, we anticipate that FDA will be open for the filing of notifications, provided there is discussion with the Agency first; during these discussions, anyone who wishes to file a notification should plan to be able to discuss such subjects as exposure estimates, toxicological considerations, if any, etc. Although we understand that this report may lack the details some of you desire, our intent is simply to share with you what we know and, thereby, provide you with a potential head start on any preparations you might care to make. For example, if you are anticipating filing a Food Additive Petition in the immediate future, we recommend delaying submission for a week or so until the signing takes place and then arrange a conference with FDA to discuss the possibility of filing an FCN instead. The "who to call" and similar information is expected to be in the post-signing letter mentioned above, so we do not have that information now. Thereafter, it obviously will be important to see what is in the Guidance documents, so you can be sure we will be active in this regard. Moreover, FDA plans to have staff members appear at public meetings being held around the country, including the December SPI FDCPMC meeting, so you will be hearing lots more about the new era. One final note. You may have been reading in the trade press that we will have to lobby to obtain appropriations for the program from Congress on an annual basis hereafter. In our opinion, this is not true. It is, of course, true that all government operations have to be funded by Congressional appropriations and, to this extent, the FCN system will have to be funded like all of FDA's activities. However, as things stand, the Agency is now planning to consider the funding for the program as part of its base budget from now on. Thus, at least as long as Commissioner Henney is in office and Joe Levitt is Director of the Center for Food Safety and Nutrition, the money will be requested in the normal budgeting process, no special appropriations effort will be needed, and the question of user fees is, for now, moot. Consequently, unless the President does not sign the Agriculture Appropriations Bill (a very unlikely prospect), we now have the FCN program and need not anticipate the need for seeking special appropriations or legislation authorizing any sort of fees for premarket notification.
On October 26, 1999, FDA will hold a training session for members of the pharmaceutical industry to discuss the contents of FDA’s guidance for industry entitled "Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation." The purpose of the training is to clarify the Agency’s recommendations on container closure systems information that applicants should provide in support of applications for human drugs and biologics. Thus, the session will be of interest to all who submit Drug Master Files on packaging. Deborah Ziffer of our office will be attending the session and preparing a report to be included in the next letter to the Committee.
Responding to critics’ concerns that innovator pharmaceutical companies take advantage of the current citizen petition process in an attempt to delay marketing of generic drugs, FDA is taking steps to limit the scope of subjects for which citizen petitions can be filed. The not yet issued draft rule, which was submitted to the Office of Management and Budget for approval last September, is understood to include provisions for increasing the Agency’s options for handling citizen petitions.
At the behest of the Food Irradiation Coalition, of which SPI is a part, Senators Richard Lugar (R-Ind.) and Tom Harkin (D-Iowa) sent a letter to Health and Human Services Secretary Donna Shalala urging that FDA place the coalition’s petition for irradiation of ready-to-eat foods on its expedited review track for processes that are designed to decrease the risk of foodborne illness. The letter stated that irradiation "has proven both safe and effective, and holds the promise of helping to significantly reduce the risk of foodborne illness in this country." Further, "because of the substantial human health consequences involved," the United States Department of Agriculture (USDA) should work closely with FDA during the review process to avoid duplicative efforts and facilitate expeditious review. USDA Secretary Dan Glickman also received a copy of the letter. While the discussion of irradiation has been centering on the food irradiation issues, the food industry is beginning to push for more discussion of the irradiated food packaging questions, too; members attending the December meeting may expect to hear more about the subject then.
On October 8, 1999, the Governor of California approved California S.B. 332, which broadens the state’s deposit law to increase deposit rates and expand the types of containers subject to the law. The law itself will take effect January 1, 2000; however, the labeling requirements in the bill will not take effect until January 1, 2001. * * * As always, if you have any comments or if we can provide further information on any of the issues discussed above, please do not hesitate to contact me, Ralph Simmons, or Deborah Ziffer. Sincerely yours, Jerome H. Heckman Back to Top More About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . Terms and Conditions of Use |
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 © Copyright 2005 The Society of the Plastics Industry.
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