Document 0JVwQoVqa0xo128Jy7zkg9ZdJ

INC CHEMICALS GROUP Five Executive Mall, Swvdaiford Road, Wayne, Pa, 19037 8 April 1976 Mr. David Hostetter Consolidated Molded Products Warner St. and Greenwood Ave. Scranton, Pa. 18501 ' Res STA-FLOW 2025 B Clear 50 Lot 212-5 Dear Mr. Hostetter: We have been informed by Mr. Edward Ott that on behalf of your concerned employees you have raised a question about the cancer warning label on the referenced lot of STA-FLOW PVC compound. Thia particular lot of STA-FLOW was manufactured by Air Products in 1975, and it was Labeled in accordance with the then prevailing OSHA standard on vinyl chloride, since that time, we have received an Interpretation from OSHA to the effect that PVC resins and compounds with extremely low residual levels of vinyl chloride monomer are exempt from the standard if further processing is not likely to result in worker exposure to vinyl chloride above the action level without regard to the use of engineering controls. We have checked our quality control records on STA-FLOW Lot 212-5, and we find that the residual monomer level is low enough to exempt it from the standard. Accord ingly, the cancer warning label is not required, and may be removed or obliterated. As e result of recent improvements in our manufacturing and quality control techniques, we are now able to produce routinely STA-FLOW products that are exempt from the OSHA standard. If you have any other questions we would be happy to respond further. nns*Rwr! bcc: A. R. Adams J. T Barr E. Ott AP66b20f 72 To From INTEROFFICE MEMORANDUM Distribution R. H. Schenck Subject PVC Date 27 December 1975 Public Relations (Location, Organization, or DapinmanO (Location, Organization, or Dtptrtmtnt) Distribution A* R. Adams J. T. Barr R. Fleming G. J. Mantel The SPZ has arranged with Kill ft Xnowlton (its public relations firm) to brief industry representatives on the pvc--VCM situation and to prepare them for making public responses. Ross Adams has designated the author and recipients o this memo as APCI's representatives. The first briefing session will be in Kew Fork on January 8 and 9. I realize this is extremely short notice, but would you please call Don White of Kill 6 Knowlton (212)697-5600 and advise him of youravailability those days. .v RB5*swc R. H. Schenck 1320) AP00020173 CHEMICALS GROUP Fiv* E*cutiv* Mall. Swd*fo'd Raid. Wyo. Fa. 19087 18 December 1975 Hearing Clerk Food and Drug Administration Department of Health, Education and Welfare Room 4-65 56Q0 Fishers Lane Rockville, Maryland 20852 Re: Docket No. 75 N-0190--Vinyl Chloride Polymers in Contact With Food; Notice of Proposed Rulemaking, 40 Fed. Reg. 40529, September 3, 1975 Dear Miss Peterson: Pursuant to Section 4 of the Administrative Procedure Act, as amended, 5 U.S.C. Section 553(c), the above-referenced Food and Drug Administration Notice of Proposed Rulemaking, and its subsequent Notices extending the time for the filing of Comments in this proceeding (40 Fed. Reg. 50277, October 29, 1975 and informal notice given on December 4, 1975), Air Products and Chemicals, Inc. (hereinafter referred to as "Air Products") hereby respectfully submits its Comments with regard to the proposed amendments to Part 121 of the Food and Drug Administration's Regulations set forth in the September 3, 1975 Notice. AP00020174 t % A ChtwCai*- Miss Peterson 18 December 1975 Page 2 Air Products supports and concurs with the Comments submitted by The Society of the Plastics Industry, Inc. ("SPI"), but wishes to draw special attention to those aspects of the proposed amendments to Part 121 most important to it. Spe cifically, Air Products objects to the proposed amendment to 29 CFR Section 121.2521 relating to vinyl chloride-propylene copolymers. As shown by the data attached hereto and incorporated herein by reference, there is no reasonable expectation that vinyl chloride monomer will migrate from food packaging material conforming to existing 21 CFR Section 121.2521 to ood. simulating solvents under exaggerated test conditions. A fair evaluation of this data leads to the conclusion that vinyl chloride-propylene copolymer food packaging conforming to the proposed regulation set forth in Exhibit A to the Comments of the SPI is safe, and that there is no basis under section 409 of the Act (21 U.S.C. 348) for revoking or amending Pood Additive Regulation 21 CFR Section 121.2521. A series of blow-molded one pint bottles made of a vinyl chloride-propylene copolymer compound conforming to AP00020175 Miss Peterson 18 December 1975 Page 3 121.2521 were tested for extraction of vinyl chloride monomer in food simulating solvents (water, dilute acetic acid, 50% ethanol and heptane) using test methods with a lower detection limit of 0.020 ppm. No vinyl chloride monomer was detected in the solvents contained in sample bottles containing less than 1 ppm residual vinyl chloride. Since the compounds tested are suitable for both bottle and sheet applications, the test results are applicable to both. in view of the foregoing, the Pood and Drug Administration is respectfully urged to take the action requested by the SPI in Section VIZ of the SPI Comments, and the FDA is specifically urged to withdraw the proposed amendment to 29 CFR Section 121.2521 relating to vinyl chloride-propylene copolymers. Very truly yours RHS*swc I Attorney bees A. R. Adams j. T. Barr j. Mantell Jerome Heckman Ralph Harding AP00020176