Document vVKMmZpdEb7ZjpqLvZoV8B7Qb

JOSEPH E KELLER JEROME H HECKMAN Charles m meehan WILLIAM H BORGHESAN1, JR, ROBERT R TIERNAN MALCOLM D MACARTHUR WAYNE V BLACK DAVID L HILL MARTIN W 0EPCOVICI JOHN S ELORED CAROLE C HARRIS MICHAEL F MOARONE LARRY S SOLOMON JOHN 5 DUBECK LAW OFFICES Keller and Heckman 1130 17TM STREET, N. W. SUITE lOOO CHRISTINE A MEAGHER SHIRLEY S rUJIMOTO PETER L. D( LA CRUZ LAWRENCE P HALPRIN DEBORAH SHUR TRINKER C, DOUGLAS JARAETT EDWARD L KORWEK ROBERT L FLESHNER JONATHAN P. LEVINE SHEILA A MILLAR RUSSELL H FOX LEE M WEINER ANGELENA C LC BLANC WASHINGTON, . C- 20036 (202) 457*1100 November 12, 1982 telecopier (202:206'76SZ CABLE address KELMAN WRITER'S DIRECT DIAL NUMBER (202) 457-1110 Stephen Higgins Acting Director Bureau of Alcohol, Tobacco and Firearms Department of the Treasury 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20226 Re: Use of Polyvinyl Chloride (PVC) for Manufacturing Plastic Liquor Bottles Dear Mr. Higgins On November 3, 1982, the Department of Treasury released an Environmental Assessment of polyethylene terephthalate (PET) for use in liquor bottles. Page 13 of the Assessment contains a response to Comments that we filed on behalf of our client. The Society of the Plastics Industry, Inc., that polyvinyl chloride (PVC) also be approved for liquor bottle use. The reply states that ATF does not intend to address the use of PVC for manufacturing liquor bottles until there is clear evidence that FDA sanctions the use of PVC for such an application. We are writing at this time to request that you address a new in quiry to the Commissioner of Food and Drugs regarding the status of PVC for packaging distilled spirits. FDA last commented to ATF regarding this issue in a letter dated January 13, 1981, from Richard J. Ronk, Deputy Director, Bureau of Foods. In that letter FDA indicated that it was reassessing its policies regarding indirect additives largely because of the recent court decision involving acrylo nitrile bottles (Monsanto v. Kennedy, 613 F.2d 947 (D.C. Cir. UCC 028926 Stephen Higgins November 12, 1982 Page 2 Keller and Heckman 1979)). On April 2, 1982, FDA announced a significant new policy regarding "constituents" in packaging materials. 47 Fed. Reg. 14464. The notice specifically refers to residual vinyl chloride monomer as the type of "constituent" that would be covered by the policy. The Notice also stated that FDA would implement the policy on a case-by-case basis as administrative needs required. On August 31, 1982 Gerard L. McCowin, Director, Division of Food and Color Additives, Bureau of Foods, wrote to me stating, "we wish to develop proposals, utilizing the constituents policy, to initiate final action on the food-contact use of ...vinyl chloride polymers." In this connection, Mr. McCowin asked for information on residual vinyl chloride levels and markets for PVC to enable FDA to make calculations from an actual data base rather than by using estimates. We have now provided FDA with information (a) showing the industry can provide PVC bottles suitable for packaging distilled spirits with a residual vinyl chloride level that does not exceed 10 parts per billion and (b) demonstrating that migration of vinyl chloride to the contents of such bottles will not exceed the upper limit established by the application of the constituents policy. Thus, in our opinion, FDA should now be in a very sound position to make a clear statement that the use of PVC bottles with an appropriately low residual vinyl chloride level is suitable for packaging distilled spirits. As you may be aware, ATF already has a substantial amount of data in its files regarding the suitability of PVC as a liquor container. A petition requesting that ATF approve polyvinyl chloride (PVC) for liquor bottle use was filed by SPI on January 22, 1980. On June 5, 1981, you requested the submission of new sample bottles for storability testing. The requested samples were hand-delivered to Dr. Charles Midkiff at ATF National Laboratory on August 24, 1981. In light of this background, we would hope that you will have everything necessary to make a suitability determination regarding PVC for use as a liquor bottle once FDA affirms the satisfactory status of this plastic from a health standpoint. UCC 028927 Stephen Higgins November 12, 1982 Page 3 Keller and Heckman We would greatly appreciate your prompt attention to this matter. Very truly yours, 'Jerome H. Heckman cc: Dr. Arthur Hull Hayes, Commissioner of Food and Drugs Dr. Sanford Miller, Director, Bureau of Foods Mr. Richard Ronk, Deputy Director, Bureau of Foods ucc 028928