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 SPI
- Food, Drug, and Cosmetic Packaging Materials Committee * * * For Members Only * * * Table of Contents
Dear Ladies and Gentleman: This letter provides you with information on a number of developments that are of interest to the packaging industry. First, we discuss the current status of the Food Contact Notification program and the efforts at FDA to improve review times of food additive petitions in general. The letter also addresses the possibility that the United States will impose 100% tariffs on plastic packaging imported from Europe. We also discuss recent developments at FDA concerning a number of starting materials for food-contact products, including acrylamide, butadiene, styrene, and diethylene glycol.
1. FDA to Issue Guidance Instead of Regulations for the Food- Contact Notification Program Previously, we reported to you that Congress appropriated $500,000 for the implementation of the Food-Contact Notification (FCN) program in last year's federal budget and postponed full implementation of the program until fiscal year 2000. Since that time, we have learned that FDA's Center for Food Safety and Applied Nutrition (CFSAN) is working on implementation of the program, but that the Center is now leaning toward issuing a guidance document for submitting notifications rather than promulgating formal implementing regulations. Officials at CFSAN's Office of Premarket Approval (OPA) believe that a guidance approach would give FDA more flexibility in handling submissions and that the FCN program could be made available in a more timely manner than if the Agency followed the notice and comment procedures necessary for a rulemaking. In developing the guidance, FDA is relying, in part, on the draft regulations that the FDCPMC provided last spring. FDA reportedly will announce the guidance and its intentions regarding the implementation of the FCN program in an upcoming Federal Register notice. The notice will ask for comments on all aspects of the program, particularly with regard to permanent funding through the use of licensing fees. Many of you will recall the tremendous difficulty we encountered during last year's budget process as we attempted to help FDA procure the funding necessary to begin the program. From the outset, the packaging industry was willing to pay reasonable fees to ensure the program functioned efficiently, but certain influential members of Congress opposed any provision in the law that contained fees. We now hope that the upcoming Federal Register notice will allow us a new opportunity to raise this issue and obtain permanent funding for the program so that it will be able to function in the broad manner that it was originally envisioned - to replace the petition process for food-contact materials. FDA intends to hold a public meeting to discuss the implementation of the program around the middle of March. We will let you know more about the meeting as details become available. We also are anxious to see what funding for the FCN program the President will ask for in this year's federal budget, which is due to Congress at the beginning of February. 2. OPA under Continued Pressure to Improve Petition Review Times with Fewer Resources FDA continues to work on improving its review time for food additive petitions and to implement the new requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA), but is hampered by limited resources. Staffing for the review of indirect additives at OPA has reached its lowest point since the 1970's. While vacancies created at the beginning of the year by the retirement of two Consumer Safety Officers (CSOs), Richard White and Dan Harrison, were filled, the new hires were assigned to George Pauli's division which works on policy matters and novel food technologies. This leaves the indirect additives staff with just six CSO's and two team leaders. At this point, the OPA staff is only devoting 15-20% of their time to indirect additive petition review. With the reduction of staff, and after considering the time needed to respond to Freedom of Information Act requests, Congressional inquiries, and other such items, submissions relating to food-contact materials are likely to receive even less attention. In other news regarding staffing at FDA of interest to the Committee, Associate Commissioner Bill Schultz, who worked with us in obtaining passage of the FCN program and other matters, will soon be leaving his position as Associate Commissioner of Policy at FDA to move to a new position at the Department of Justice. Reportedly, his former position at FDA will be not be filled, in keeping with Dr. Jane Henney's (the new Commissioner) wishes to reduce the staff at the Commissioner's office. Alan Rulis, previously head of OPA, and currently Acting Deputy Director for Programs at CFSAN, will lead OPA again due to a reorganization. 3. Study Addresses Delays in OPA Reviews A recent report confirmed that toxicology reviews represent a bottleneck in the review of food additive petitions at OPA. The study entitled "Resource Evaluation of the FDA Food Additive Petition Process" was conducted by The Research Triangle Institute (RTI) at the behest of the Department of Health and Human Services. OPA officials reportedly were not surprised to learn the contents of the RTI study; however, the underlying conclusions in the report may help focus work to reduce the current petition backlog at FDA. Specifically, the RTI report stated that toxicology is the factor in petition review that places the greatest demands on OPA staff, and there are insufficient staff resources available to complete the toxicology reviews within the desired time frame. OPA officials commented that the number of toxicology reviewers does not tell the entire story because this does not account for time toxicologists spend on tasks that are not petition-related. To improve performance, OPA officials are working to prioritize petitions for review, and will ask toxicology reviewers to try to detect potential problems earlier in the evaluation process. OPA is also trying to develop a "teamwork" approach to toxicology reviews and has revised the supervisory sign-off system to limit the number of times a toxicology memorandum is reviewed to only those occasions where significant input is needed from a supervisor. Toxicology is not the only area being reevaluated after the publication of the RTI study. For instance, OPA officials are working to involve the Office of Chief Counsel earlier in the petition review process, so that post-OPA review time is cut down. Finally, OPA officials stated that their office responds to over 2,000 letters a year requesting explanation of regulations and that OPA is the only group within CFSAN that responds to its own Freedom of Information Act requests. 4. FDA Announces Expedited Review for Food Additive Petitions that Impact Food Safety FDA has developed and published new guidance on how the Agency will expedite the review of food additive petitions for substances with the potential to significantly decrease human pathogens or their toxins in food. Specifically, expedited review will be given to petitions for products that decrease pathogens such as E.coli, Salmonella, Campylobacter, Cyclospora, and Listeria. These petitions must still meet the same standards as other petitions, but they will be reviewed ahead of other pending petitions on a fast track. This new policy may adversely affect the review of petitions for food-contact materials by diverting staff currently reviewing those petitions to the expedited review process. Confirming our concern, Center officials have stated that the new expedited review process may delay other work at OPA. 5. US Threatens 100% Tariffs on Plastic Packaging Imported from Europe The United States is intending to levy punitive tariffs against $88 million worth of plastic packaging materials imported from Europe, U.S. Trade Representative Charlene Barshefsky told the World Trade Organization (WTO) in early January. The tariffs on packaging are part of the tariffs on $520 million worth of European imports that will be used in the intense trade war between Europe and the United States over bananas. Plastic packaging will be the largest category of goods selected for the punitive tariffs, followed by pastries and batteries. By March 3, and possibly as soon as February 1, imported packaging will be subject to 100% tariffs, effectively doubling the price unless a compromise can be reached. The WTO previously ruled that European restrictions on banana imports violate WTO rules. 6. FDA Establishes VSD for Acrylamide We recently learned from informal contacts with FDA that the Agency has reached a decision on a virtually safe dose (VSD) for acrylamide; however, the result is somewhat startling. FDA apparently has set the unit risk for acrylamide at 0.72 (mg/kg b.w./day)-1. This translates to a VSD of 27 parts per trillion (ppt) in the diet (as many of you know, FDA sets unit risks, from which we actually calculate the VSD). This is a very high potency; 10 times more potent than acrylonitrile and more potent than vinyl chloride, which means that several pending petitions involving acrylamide may have difficulty unless they can demonstrate residual monomer at very low exposure levels. 7. National Toxicology Program Calls for Public Comment on the Listing or Delisting of Certain Substances in the Ninth Edition of the Report on Carcinogens The National Toxicology Program (NTP) requested public comment on the listing or delisting of certain substances of potential interest to the plastics industry in the Report on Carcinogens (Ninth Edition). The following substances are under consideration by NTP: ethyl acrylate, ethylene oxide, isoprene, methyl-t-butyl ether, and nickel compounds. Ethyl acrylate is recommended for delisting from the Report. The listings for ethylene oxide and nickel compounds are proposed to be changed to reflect a rating of "known to be a human carcinogen." NTP further recommended that isoprene and methyl-t-butyl ether be listed in the Report as "reasonably anticipated to be a human carcinogen." Comments to NTP on these proposed listings are due by February 14, 1999. The Report on Carcinogens, updated biannually, is a federally maintained list of all substances either known to be or reasonably anticipated to be human carcinogens to which a significant number of people in the United States are likely to be exposed, as determined by scientific data reviewed by NTP. The Report, however, does not present risk assessments of cancer potential and therefore a substance's listing in the Report does not establish that the substance or its level of exposure presents a risk to people in their daily lives. For purposes of the Report, the listing "known to be a human carcinogen" indicates those substances for which scientific data from human studies illustrate a causal link between exposure to the substance and human cancer. The category "reasonably anticipated to be a human carcinogen" indicates those substances for which there is limited evidence of carcinogenicity in humans but sufficient evidence of carcinogenicity in tested animals. 8. Update on FDA Risk Assessments for Butadiene and Styrene In our last report to the Committee, we informed you that the risk assessment for butadiene was nearing completion and that FDA had decided recently to suspend action on petitions involving styrene while the Agency reviewed its carcinogenic potential. We now can report that, as an interim measure while the full review of styrene proceeds, FDA is calculating a "worst-case" virtual safe dose (VSD) for styrene that may allow many pending petitions to move forward. We understand that this temporary VSD should be completed in the early part of this year. In addition, in expectation of the butadiene VSD being completed in the near future, petitions involving butadiene also are beginning to be reviewed again at OPA. 9. Further Developments Concerning DEG We informed you previously that FDA was suspending the review of all food additive petitions involving diethylene glycol (DEG) as a starting material or as an impurity. This action was being taken because of concerns at the Agency regarding an old Japanese study that suggested that DEG may be a carcinogen. FDA requested that petitioners provide more information on the study. We now have learned that neither FDA nor the petitioners were able to obtain data on the study. In light of this fact, FDA will re-calculate potential exposure to DEG to discount the DEG that is bound in the polymer matrix and thus not available to cause exposure. Our sources tell us that this will enable nearly all of the pending petitions involving DEG to be cleared. 10. Finalization of GRAS Notification Procedure Languishes, but Procedure Is Being Used Citing the need to direct resources to other priorities, such as the Food Safety Initiative, OPA has failed to finalize its generally recognized as safe (GRAS) notification procedure rule, deferring this final action to some unspecified point in the future. The new rule, completion of which was scheduled for the summer of 1998, will replace the GRAS affirmation petition process with a notification procedure that will be faster, more efficient, and less burdensome than the present approach. The proposal would give FDA a deadline of 90 days to object to a GRAS notification. Companies currently can avail themselves of the new notification process by following the procedures set forth in the proposed rule, although FDA is not bound by the 90-day time constraint until the rule is finalized. A few notifications have been filed (and responded to by FDA within 180 days in some cases), but, to our knowledge, the system has been used only for direct food additives so far, although food-contact materials are not expressly excluded from the GRAS notification program. In responding positively to GRAS notifications, FDA is providing letters stating only that the Agency "has no questions at this time" about the company's GRAS determination. Although this may not be the most helpful language for customer assurance purposes, it does reflect the favorable conclusion of FDA's review of the notification. 11. Consortium Developing Ways to Expand List of Materials Permitted by FDA for Packaging Food to Be Irradiated At a November 18 meeting, the Consortium for the Expansion of 21 C.F.R. §179.45 ("Packaging materials for use during the irradiation of prepackaged foods") decided to petition FDA to allow electron-beam (e-beam) and X-ray radiation under Section 179.45(b). Since the current regulation allows for only gamma source radiation of food packaging materials, the consortium ultimately plans to amend §179.45 to include e-beam and X-ray radiation. The consortium was created under the auspices of the National Center for Food Safety and Technology (NCFST), a joint activity of FDA, industry, and the Illinois Institute of Technology. The consortium activity comes on the heels of a paper written by NCFST's Dr. George Sadler on polymer irradiation, which is entitled "The Effect of Low Ionization Density Radiation on Packaging Polymers: A Case for Broader Sanction Under 21 C.F.R. §179.45." Dr. Sadler submitted the report to Patricia Hansen at OPA. Based, in part, on Hansen's response to the Sadler paper, the consortium agreed to pursue the following possible courses of action: (1) petition FDA for e-beam and X-ray radiation under Section 179.45; (2) submit a request for a Threshold of Regulation exemption for the use of certain polymers, including polystyrene, olefin polymers complying with 21 C.F.R. § 177.1520, and polyethylene terephthalate (PET) to package food for irradiation; (3) petition the Agency to add new polymers to Section 179.45(b); and (4) petition FDA for certain additives to be included in Section 179.45(b).
As always, should you have any questions or comments regarding any of these subjects, please do not hesitate to let us know. Cordially yours, 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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