Document ev2o0L9QmrEdvnYmxZKw3nmmE

Law Offices Keller a.nx> Heckman lOOl G Street, N.W. Suite soo West Washington, D.C. 20001 Telephone (202) 434-4100 Telex 4 e&SSi "KELMAJN" Telecopier (202) 434-4040 Boulevard Lovii 5chmidt 07 B-lO-kO BnuctBLt Telephone 32(2) 732 52 O Telecopier 32(2) 732 53 02 JOECRN C. MCkLCft wCROmc M. HCCKMAN WILLIAM M EORONCSANI, J* MALCOLM O. MACARTMU* W4YWC V. LACR TERRCNCC D. VONC* MARtlH W. HCACOVlO JOHN . CLOftCD W<CUAH 4.. MOVACS CAAOLC C. MAAAIS RAVNONO A. KOWALSKI* miChacl f. morronC MARK fOK EVENS JJOCHAMN SAVKIiCKVA*ltOS JOHN 0 DUSCCK *TCA C. K 4.A CAVE eHMtSTlMC M. OlU MCLVm S. OAOtCM iHtRLCV , fVJlMOTO LAVINCNCC a. MALPRIN July 27, 1993 KALRH A, SIMMO*S RCTER A, tUlECR C. OOUOLAl IA4MCTT SMCILA A. MILLER ALTAIC* J. huro OCOROC G. MISMO CamCM C, OOOCC DAVlO 1, READER S, CRA* TAUTfCRT MAMA A. SICVCMS MICHACL A. ECNNCT THOMAS R. MOUNTEC* DAVIO <3 EARVAOl* CATHCAIMC A. NtCLSCM KIM* ANNE MOHTCITH CLLIOT ECLILOI MARK C. iTtKOff JCAM-AMCHAAC MOHTPORTn JOSTIM M. McQARtHt JCFFACV t. 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TUAMCfl WAITCA'S OlACCT DIAL MUMtCR (202) 434-4110 To: SPI Food, Drug and Cosmetic Packaging Materials Committee Re: FDA Request for Data and Samples of Vinyl ' Chloride Polymer Coatings RESPONSE REQUESTED BY SEPTEMBER 15, 1993 Dear Committee Member: Following up on our letters of May 20 and September 21, 1992, this letter is a reminder and a bit of a warning that we are still very much in need of additional information to respond to the Food and Drug Administration's (FDA's) April 27, 1992 request for data on the composition of, and residual vinyl chloride monomer (RVCM) levels in, can coatings prepared with vinyl chloride polymers. At this point we have received written responses from ALCOA and Union Carbide, to whom we are very grateful. Although we appreciate the oral responses we received from a few additional companies, to prepare an adequate response to FDA's request we need written comments from as many company producers or users of vinyl chloride polymer coatings as possible. We respectfully urge those committee members who have not yet responded in writing to complete the enclosed questionnaire no later than IS. 1993. even if only to advise us that you do not manufacture, formulate, or use vinyl chloride polymers or coatings made from them. Your timely response will enable us to provide FDA with a more complete picture of the industry's stance. Without a well-founded response, we fear that FDA will ban the use of vinyl chloride polymers as components of coatings. Aside from the immediate commercial impact this would have, a ban may be misunderstood and adversely affect the public's perception of other vinyl products. RECEIVED see 5-1613 AUG 0 3 1993 SE&T/HSE-AS INFORMATION SERVICES SPI Food, Drug and Cosmetic Packaging Materials Committee July 27, 1993 Page 2 Keller and Heckman By way of background, in response to FDA's 1986 proposed rule, The Society of the Plastics Industry, Inc* (SPI) and other commenters suggested that the Agency adopt the American Society of Testing and Materials' (ASTM) procedure for testing for the level of RVCM in vinyl chloride polymer products. While FDA generally agrees with this suggestion, the Agency has since concluded that difficulties in using the ASTM method to test coatings make it necessary to develop a different approach for assuring that a given vinyl coating complies with the proposed rule.17 In his April 27, 1992 letter (copy enclosed), Dr. Alan Rulis, Director of FDA's Center for Food Safety and Applied Nutrition Office of Premarket Approval proposed several alternatives regarding the regulation of vinyl chloride polymer coatings. The most attractive of these proposals may lead to the elimination of the RVCM limit on finished vinyl chloride polymer coatings regulated by 21 C.F.R. 175.300. To evaluate the merit of this proposal, FDA asked to review data from tests conducted by industry on the levels of RVCM in can coatings. If the data industry provides demonstrate that RVCM is not detected with a method sensitive to 1 part per billion (ppb), the Agency will consider eliminating the proposed RVCM limit. FDA also asked SPI's members to provide information on "the range of VCPcontaining formulations that are being used commercially as can coatings." Specifically, FDA is asking for information on all types of coatings currently produced with any vinyl chloride polymers. Alternatively, if FDA does not receive enough data to remove the RVCM limit for coatings, FDA proposes to modify its "purgeand-trap method" so that it can be used to determine the 17 The difficulties arise because application of the ASTM method relies upon analyzing vinyl chloride in the headspace above a totally dissolved sample. FDA has apparently had difficulty in assuring that all vinyl chloride polymer coatings will dissolve in their entirety. Furthermore, to apply their intended compliance standard expressed in units of concentration (5 parts per billion), FDA will need to determine the mass of the dissolved coating, which FDA cannot readily determine for "unknown" coated articles. In addition, the weight of RVCM in the coating of a single can is so small that the solvent from several cans will need to be combined, leading to opportunities for losses. see 5-1619 SPI Food, Drug and Cosmetic Packaging Materials Committee July 27, 1993 Page 3 Keller and Heckman compliance of vinyl chloride polymer coatings. FDA will require cans with samples of a variety of vinyl chloride polymer coatings, as well as the information requested above regarding the range of commercial can coatings currently available, to examine this alternative. Finally, FDA noted the possibility that it might prohibit the use of vinyl chloride polymer coatings in food-contact applications if industry does not provide a sufficient amount of the information outlined above. Thus, the Agency could decide to eliminate the use of vinyl chloride polymer can coatings for food-contact applications. In light of vinyl chloride's lengthy regulatory history and the public's perception of vinyl.chloride in general, regulatory condemnation of a particular product may have important repercussions for other vinyl chloride products as well. We hope to avoid the imposition of a ban or the establishment of an unreasonable compliance method by providing FDA with data showing a suitably low level of RVCM in vinyl chloride polymers. Toward this end, we circulated this material and spoke with a number of companies that provided information and data. However, we are still faced with substantial data gaps and weaknesses. To make it easier for companies to provide information, we have prepared a questionnaire for use by resin manufacturers, coating formulators, and manufacturers of coating substances. The questionnaire includes more background on FDA's request and explains precisely what data are needed. If you have already provided information as a result of our previous surveys, please contact us so that we may discuss remaining data needs. In any case, please fill out the applicable section of the questionnaire and return it to us by September 15. 1993. Only the composite data will be submitted to FDA; all proprietary and trade secret data will be kept strictly confidential. Please also let us know of any other companies that may be involved in the manufacture of relevant products so that we may contact them as well. ** * see SPI Food, Drug and Cosmetic Packaging Materials Committee July 27, 1993 Page 4 Keller and Heckman Thank you in advance for your assistance in providing the necessary information. If you have any questions about the questionnaire or FDA's request, please contact Dr. Lester Borodinsky (202/434-4154) in our office. Cordially yours. Jerome H. Heckman Enclosures cc: Larry Thomas Lewis R. Freeman, Jr. Hugh Patrick Toner Meredith Scheck (for Vinyl Institute Distribution) Maureen Healey see QUESTIONNAIRE The Food and Drug Administration (FDA) has asked industry for additional data regarding the composition of, and residual vinyl chloride levels in, finished coatings to assure that coating formulations comply with the residual vinyl chloride monomer (RVCM) limits in FDA's 1986 proposed rule governing the use of polyvinyl chloride (PVC) food-contact materials. (See attached April 27, 1992 letter from Dr. Alan Rulis, Chief of FDA's Division of Food and Color Additives.) It is to be hoped that such data will allow FDA to conclude that the residual levels are low enough to eliminate the need for a residual monomer limit on the finished coatings. If such residual data are either not available or demonstrate that the levels in some coatings are high enough to require controls, FDA has alternatively requested samples of coated cans for the development of a compliance method. The third alternative stated by the Agency, should data and/or samples not be forthcoming, would be to ban the use of vinyl chloride polymers as components of coatings. This questionnaire is designed to facilitate the collection of the relevant available data on formulations and RVCM levels of current food-contact applications of can coatings that contain vinyl chloride polymers. The goal of the survey is to collect and share this information with FDA to ensure that the safe use of these materials can be continued without the need to supply FDA with coating samples for a further round of testing. To help us prepare an adequate response to FDA's request, we would appreciate it if you, in addition to filling out the questionnaire, would provide us with the names of other firms that may be involved in the manufacture of relevant products so that we may contact them. To ensure that we will be able to provide the most recent and consistent data available, please utilize data from 1992, if possible. If you are unable to report data from 1992, indicate the year(s) for which the data are applicable. The questionnaire has been divided in parts that reflect the various segments of the coating industry: (1) manufacturers of vinyl chloride polymer resins; (2) coating formulators that incorporate one or more vinyl chloride polymer resins into formulations; and (3) manufacturers that apply the coatings to metal substrates to produce either finished food-contact articles or coated metal stock that is subsequently fashioned into finished food-contact articles. Please respond only to that part of the questionnaire that is relevant to your company. 1 5 16 '2 2 Since FDA is in need of the residual VCM data in relation to a rulemaking procedure, any data reported to FDA must be of a quality comparable to that needed for a Food Additive Petition. Therefore, if you have data on residual VCM in finished coatings in your files, please provide a complete report of the data, including the samples used in the test, the analytical method employed, and data obtained, including any data used to calibrate the method. The report should also contain copies of appropriate instrumental output. To help us provide the necessary data, we would appreciate your response to the attached questionnaire by September_15_t 1993. Be assured that all proprietary and trade secret data will be kept completely confidential. Only composite composition data will be submitted to FDA. If any request is made for individual company data, a highly unlikely event, the company will be notified so that it can provide the data to FDA by means of a confidential filing, or simply refuse to file it. If you should have any questions about this matter, please contact Dr. Lester Borodinsky (202-434-4154) at Keller & Heckman. All completed questionnaires should be sent to the attention of Dr. Borodinsky, at the following address: Keller & Heckman 1001 G Street, N.W. Suite 500 West Washington, DC 20001 2 SCC 5-i/o- Part I: Resin Manufacturers Provide the information requested for each vinyl chloride polymer resin manufactured by your company. If data on residual vinyl chloride monomer (VCM) are available, please include a report of the data, including instrumental output and data to validate the analyses. Identity and Composition of Resin^ Estimate of Percentage of Food Packaged in Cans Coated with Coating from your Company's Company's Resin (by Food Type)^ If Available, Residual VCM level in Finished Coatings sex If Indicate whether the resin is a solution vinyl resin or a vinyl chloride polymer dispersion. In addition, indicate the composition of the polymer if a copolymer. 2f The percentage relating to your company's product(s) should reflect the amount of food in cans that employ coatings that contain vinyl chloride polymers. Relevant Food types are Aqueous (Aq), Acidic (Ac), Alcoholic (Al), and Fatty (F). Part II: Coating Formulatora Provide the information requested for each vinyl chloride polymer coating formulation manufactured by your company. If data on residual vinyl chloride monomer (VCM) are available, please include a report of the data, including instrumental output and data to validate the analyses. Identity and Composition of Coating Formulation^ j Estimate of Percentage of Food j Packaged in Cans Coated with | Your Company's Coating (by Food Type)^ If Available, Residual VCM level in Finished Coatings 1/ Indicate the complete composition of the coating formulation. Indicate whether the resin is a solution vinyl resin or a vinyl chloride polymer dispersion. In addition, indicate the composition of the polymer if it . is a copolymer. 2/ The percentage relating to your company's product(s) should reflect the amount of food in c.n cans that employ coatings that contain vinyl chloride polymers. Relevant Food types are Aqueous (Aq), Acidic (Ac), Alcoholic (Al), and Fatty (F). see Part III: Manufacturers of Coated Substrates Provide the information requested for each vinyl chloride polymer coating formulation used by your company. If data on residual vinyl chloride monomer (VCM) are available, please include a report of the data, including instrumental output and data to validate the analyses. Identity and Composition of Coating Formulation^ To the Extent Feasible, Estimate of Percentage of Food Packaged in Your Company's Coated Products (by Food Type)^ 1 | If Available, Residual VCM level in Finished Coatings 1/ Indicate the complete composition of the coating formulation, if known. In addition, indicate whether the vinyl chloride polymer resin(s) used in the formulation(s) is a solution vinyl resin or a vinyl chloride polymer dispersion, if known. Also, indicate the thickness and approximate density of the finished coating. 2/ The percentage relating to your company's product(s) should reflect the amount of food in cans that employ coatings that contain vinyl chloride polymers. Relevant Food types are aqueous (Aq), acidic (Ac), alcoholic (Al), and Fatty (F). see