Document bv2YqywEg0KkpmRXgYK8n2K0

Hied . Signal LawD partm nt 'To M morandum 'Cfijui sI*xJ2 ~~ x&'v<&M0P Fe' *" ------------------ J. B. CHARM R. O GHERGHEL E. T. KUBU dwUjb&x*Lfrc P Re: FDA - PVC Proposal Enclosed is proposed PVC regulations and commentary by Keller and Heckman. The sections relevant to our operations are found on Page 4184 of the FEDERAL REGISTER proposal dated February 3, 1986. Item B, Col. 1, Page 4184, is directed to new regulation 21 CFR 177.1975 - Vinyl Chloride Polymer Resins, Rigid and Semi-rigid. The proposed regulation is found on-Page 4187. This regulation provides for the safe use of rigid and semi-rigid PVC -- the operative limitation being that the finished food contact articles contain a residual VCM (RVCM) level not in excess of 10 ppb by weight of the PVC. Item C, on Page 4184, and corresponding regulation 21 CFR 181.37 (Page 4188), provides for use of prior sanctioned PVC plasticized films, the operative limitation being that the RVCM content not exceed 5 ppb. I talked to Keller and Heckman and they advised me that the plasticized material has a limitation of 5 ppb versus 10 ppb for the semi-rigid or rigid, because the agency feels that the 5 ppb is reasonably achievable by the industry for plasticized PVC and 10 ppb is reasonably achievable for the rigid and semi-rigid. Rigid PVC is defined in ASTM D 883 as that having a modulus in excess of 100,000 psi and semi-rigid PVC has a modulus between 10,000 psi and 100,000 psi. Flexible or plasticized film would include anything below 10,000 psi. I am advised by Dr. D. Dixler of Keller and Heckman that the calculation of residual monomer should be made against the total weight of the film, not merely the PVC component. PR 0002581 If you have any reaction to the proposed regulations or Jerry Heckman's comments relative thereto, please advise me as soon as possible, so that we may make the March 4, 1986, deadline requested. in particular, do you have any comments on the proposed test for determining RVCM (see Item 4 of J. Heckman's letter)? y I am also enclosing for previous resins a copy of the letter from Keller and Heckman, which we have been using as a guideline to this point. PLH:plb Enclosures CC: D. P. Burnham w/enc. J. B. Oelkers " " A. J. Stewart " " H. W. Tenney " " Patrick L. Henry 2- - ASI-PR 0002582 ALLIED CHEMICAL CORPORATION LEGAL DEPARTMENT January 31, 1974 MR. W. S. FERGUSON With respect to the Department of labor request on vinyl chloride, we might consider (1) what information we might have to'offer; (2) whether this information might be coming in from other sources and (3) whether our financial interests in vinyl chloride warrant extensive direct involvement. ccs: Messrs. E. W. Callahan E. M. Dixon W. A. Knapp J. M. Quinnv^ ASI-PR 0002583