Document ev8YOv44gxdO3wKgo1JeEdQqG

u JOSEPH E. KELLER JEROME H. HECKMAN CHARLES M. MEEHAN WILLIAM H. BOROHESANI, JR. ROBERT R. TIERNAN WAYNE V. BLACK DAVID L. HILL MARTIN W. BERCOVICI JOHN S. ELDRED CAROLE C. HARRIS MICHAEL P. MORRONE LARKY S. SOLOMON JOHN B. DUBECK CHRISTINE A.MEAOHER SHIRLEY S. FUJIMOTO PETER L.BB la CRUZ * LAWRENCE P. HALPRIN DEBORAH SHUR TRINKER C. DOUGLAS JARRETT EDWARD L.XORWSK ROBERT L. PLESHNER JONATHAN P. LEVINE SHEILA A. MILLAR LAW OPPICES Keixeh and Heckman USO 17TM street, n. w. suite 1000 WASHINGTON, D. C. @0030 April 22, 1981 TELEPHONE 303-437-1100 CABLE ADDRESS "KELMAN" WRITER'S DIRECT DIAL NUMBER (202) 457-1110 e A Up 'V Lr# i V * APR 27 19Q1 * OHIO BAN ONLY TO; All Members Of: ,:f;v!";or!:.ir.iiTAL cor:mi' SPI--VCM/PVC Mailing List -Plastic Bottle Institute -Plastic Beverage Container Division -AN Polymers Group -PET Safety Group -Food, Drug & Cosmetic Packaging Materials Committee -PVC Safety Group . -Public Affairs Committee Re: Status of Plastic Liquor Bottles at BATF Letter Highlights 1. The Bureau of Alcohol, Tobacco & Firearms (BATF) is now expected to deny (or indicate an intent to indefinitely delay action on) the SPI Petition for Generic Approval of Polyvinyl Chloride (PVC) to package liquor; its action will be premised on the Food and Drug Administration's (FDA) re fusal to give its blessing to the Petition. We are hopeful that BATF's action will help to focus Administration and Congressional interest on the Food and Drug Administra tion's refusal to affirm the safety of PVC food packaging. 001672.001 2- - Keller akd Hecsman 2. BATF continues to review a pending appli cation regarding the use of polyethylene terephthalate (PET) for packaging liquor. It appears that a policy decision has yet to be made on the question of what consti tutes an acceptable proof gain. 3. BATF is now giving some thought to the reg ulatory mechanics of approving plastic liquor bottles. One alternative could re quire completion of a rule making proceed ing before any plastic bottles are approved. Ladies and Gentlemen: On Friday, April 17, 1981, John Dubeck and I met with Ray Conrad, Bureau of Alcohol, Tobacco & Firearms (BATF), Act ing Chief of the Special Operations Branch in the Trade and Consumer Affairs Division (he is acting for Dorothy Lee while she recovers from an illness), Mike Dressier, a "Tax Special ist" in the Special Operations Branch of that Division, and Robert White, a "Tax Specialist" in the Research and Regula tions Branch of the Regulation and Procedures Division to dis cuss general issues relating to approval of plastics liquor packaging. At the outset, let us apologize for the fact that you will not find this report as clear cut and definitive as either you or we would like. The events that lead to the meeting may help to ex plain why we have nothing definite to report. A week or so ago, Mr. Tom George, Chief of the Regulation and Procedures Division at BATF called us on his own initiative so he could inform us about some vague "rule making plans." After think-, ing this rather puzzling contact over, we advised BATF that we would like to have a meeting so that we could better under stand the significance of this development. This request was initially rejected because we were told that no final deci sions had been made and there was nothing that BATF could tell us. We offered to meet with them anyway, even if only to share with them some of our background involving the regulation of plastics packaging. They agreed that such background could be useful as they consider whether there is a need for rule mak ing regarding plastic liquor bottles. 001672.002 -3 Reixer and Heckman PVC Liquor Bottles As you all know, the latest development with regard to PVC liquor bottles was a letter from Dick Ronk to BATF dated January 13, 1981. Despite the fact that it took the Food and Drug Administration (FDA) a year to write the letter, BATF has already decided that the FDA response is too nebulous to sup port BATF approval of PVC liquor bottles. We have now been told that BATF intends to deny, or inform us in writing that it intends to indefinitely delay action on the SPI Petition requesting generic approval of PVC for liquor packaging. While we would have preferred that the Petition be approved, BATF's response should help to focus Administration and Congressional interest on FDA's handling of PVC both for liquor bottles and food packaging and, hopefully, bring about formal FDA recognition of the safety of PVC food packaging. Accordingly, we advised BATF that we would like to receive the letter as soon as possible. PET Liquor Bottles Consistent with its tight-lipped policy regarding its review of an application for a polyethylene terephthalate (PET) liquor bottle, we did not receive any details regarding the status of this application, other than that some of the technical reviews are still not complete. We have no idea how many technical issues remain to be resolved; however, we did learn that there has been no policy decision made as yet re garding the degree of "proof gain" that will be considered acceptable. One minor difficulty concerns the fact that the FDA food additive regulation for PET only covers alcoholic bever ages up to 100 proof. Read literally, 100 proof liquor could not be packaged in PET because if any proof gain did occur, the bottle would not comply with the food additive regulation. We suggested that such an interpretation would be unduly re strictive and, in our opinion, was not required under the Fed eral Food, Drug and Cosmetic Act. 001672.003 - 4- Kjeuler and Heckman General Issues Regarding Plastics Liquor Bottles BATF's newfound concern regarding the regulatory mechanics for approving a plastic beverage container can be viewed optimistically as indicating that BATF anticipates approving such packaging in the near future. For those who thought that the near future might be a matter of weeks, the news is not heartening. Since we have no idea what the nature or scope of any potential rule making might be, it is impos sible for us to comment upon the significance of this develop ment. Conceivably, the rule making proceeding could be little more than a Federal Register Notice that specific plastic liquor packaging will be approved upon appropriate application by a distiller. The first such approval might then follow within thirty days. The most depressing possibility is that BATF could adopt a procedure comparable to FDA's food additive petition procedure, complete with the inordinate delays in volved therein. We vigorously suggested that the FDA model be avoided at all costs, and that BATF either continue to grant applications as in the past, or develop a rule which would allow simple registrations and preclude long delays. Since BATF said very little on this subject and com mitted to nothing, we can only report that BATF seemed willing to listen to (and perhaps even enjoyed) our horror stories re garding FDA-regulations. Ray Conrad, in particular, seemed genuinely interested in not repeating the regulatory mistakes of others. At this time, we have no idea whether BATF will indeed decide that a rule making proceeding is necessary. The June meeting of the SPI Food, Drug, & Cosmetic Packaging Materials Committee should be the best opportunity to find out more about BATF's plans since Alan Graham, Chief of the Commodity Classification Branch of the Trade and Consumer Affairs Divi sion of BATF has agreed to be a speaker on the program. The Commodity Classification Branch is responsible for the tech nical evaluation and approval of liquor packaging. If you should have any questions, or if we can be of any further assistance, please do not hesitate to contact us. 001672.004