Document dZvQ5O6936VxnJdg30Ygq8o6

OSHH : Ac JOSCAM C. KCLLCA JCKOMC H. HCCKMAM CHAALCS M. MCCHAM WILUAM M. OftOMC&AMI. JM. MALCOLM 0. MACAMTMUM WAYNt V. BLACK MARTIN W. SCNCOV'CI JOHN S. CLDRCO CAftOLC C. MAAftlft MICMACL r. MORROWC jOmh a. oubcck RCTCR L. u CRU* CHAISTINCA. MCAOHCR SMIALCY S. rUJlMOTO LAWRCMCt A. MAUAAIH COWARO L. KOHWIK TCAACHCC O. UOHCS MANY MANTHA MCNAMARA mark r* cvcms RALPH A. SIMMONS C. OOUOL`4 JAAACTT ACTCA A. SUSSCR SNIIU^ Mli.LAN , RUSSCLl. M, I'OX JAN M. WAMSTCO ILCNC Rli.CfL MCtUCA SUSAN T CCNTI SUSAN U. SLUM MAAK C. HAy^S SANOAA J>. OCNMIS PATRICK J. HMNO* c. AOAM LYCHS s. CRAIO T*lVP*JT QAVIO H. J#TTM `AOMlTTEO IN VtROlNIA ONLY AOMITTCO IN PENNSYLVANIA ONLY LAW QFFICES Keller and Heckman 1150 IT*" STREET, N.W. SUITE lOOO WASHINGTON. D.C. 20036 (202) 030-5600 hfcCEIVED SEP 41986 scientific staff DANIEL S. OIXLCR OURWAAO r. OOOCCN CHARLES V. SflCOC* T CLCX A B999I TELECOPIER 1202) 2-7e<2 DR.R.T. GOTTESMAN cable adorcss -kclman- WAITCft'S OlACCT OIAL NUM8CR September 3, 1986 (202) 956-5641 Roy T. Gottesman, Ph.D. The Vinyl Institute Wayne Interchange Plaza II 155 Route 46 Wet Wayne, New Jersey 07470 Re: OSHA Regulation of PVC Resins and Compounds Dear Roy: Enclosed is a letter we sent to John Miles at the Occupational Safety and Health Administration (OSHA) concerning the labeling of vinyl chloride polymers and copolymers. We will try to obtain some reading from OSHA before the Vinyl Institute Executive Board meeting next week. In the interim, if you have any comments or questions please let me know. Cordially yours. cc: Robert D. Luss, Esq. Charles E. O'Connell Lewis R. Freeman, Jr. Margaret Rogers Peter L. de la Cruz SPI-03038 >QM| M NCC' WILLIAM M lOMHlUNI. JA MALCOLM O MAATMW WATMt V lkAf MARTIN (COVtCl johns clOmco CAAOlC C maaa.a MlCMAKL t MOAAONC JOHN DWACCA A(TC L Mtt C*u> AMlALCTA TUJ'MOTO LAA(NCt MALAIM COWAAO L KOAWCA TfAACMCt 0 JON C A NAK lUNtHA MC MAMAA A NIH AON (V|NI *AL*M A IIMMONA C OOWOLAAJAAAJTT KTf" a AWAACA III A A MILL A A AVAACLL M AO* JIN M WAMATCO lUlAN T CONTI tUAAN J ILUH MAM C MATCA RjNONA J A OC MM IA NATAlC* j HUID* C AOAM L(T(MA A CAAlO TNjTfCIt OAVIO M JfTT" AOMlTTCO IM viaoimia Omla **ADM'TT(e IM AIMMATIVAMIA ONL> law orriCEs Keller and Heckman 11*0 17'* STREET. N.W. SUITE lOOO WASHINGTON. D.C. COOOO (coc) ose-&eoo August 29, 1986 AC'CMTiAc ATArr OamiCl t 0<k.C* OUATMAAO 9 DOrOCN CmaAlCS V MtMl TCLO TCLtCOMICA (too ? CAAlCAOOACSS "HClmam WAlTCA OlACCt OlAL MWMACA (202) 956-5641 Mr. John B. Miles, Jr. Director Directorate of Field Operations Occupational Safety and Health Administration U.S. Department of Labor 200 Constitution Avenue, N.W. Washington, D.C. 20210 Re: OSHA Regulation of Vinyl Chloride Polymers and Copolymers Dear John: This letter follows our meeting on July 11, 1986 with you, Roy Gibbs and Gail Brinkerhoff. I requested the meeting to discuss the labeling of polyvinyl chloride (PVC) homopolymer and copolymer resins and compounds under the Agency's vinyl chloride standard and hazard communication standard. You had just returned to the office from extended travel the previous day and had not had an opportunity to personally review these issues. Mr. Gibbs and Mr. Brinkerhoff expressed some preliminary staff views. The basic issue was whether vinyl chloride polymer and copolymer resins or compounds must be labeled as a carcinogen under the Occupational Safety and Health Administration's (OSHA) vinyl chloride standard. As detailed in my letter of June 18, 1986, we believe that the cancer warning label is required under the vinyl chloride standard only when workers handling PVC products are exposed to vinyl chloride monomer at or above the action level of 0.5 parts per million (ppm). Our position was derived from industry discussions with the OSHA SPI-03039 Mr. John B. Miles, Jr. August 29, 1986 Page 2 Keller and Heckman staff at the time the standard was promulgated, the Agency's interpretations of the term "fabricated product," and the Secretary's litigation position on the applicability of the training requirements under the vinyl chloride standard. Further, since the hazard communication standard requires carcinogen labeling only when the residual level of a carcino genic component is 0.1% or greater, it follows that our inter pretation of the vinyl chloride standard is much more stringent than that imposed on other carcinogens under the hazard communication standard. As I understood Messrs. Gibbs and Brinkerhoff's pre liminary comments, PVC resin or compound would always have to carry the carcinogen warning label under the vinyl chloride standard regardless of the residual vinyl chloride level or potential for worker exposure. This appeared to based on a zero-threshold approach to carcinogen regulation. Obviously, this directly conflicts with the 0.1% level in the hazard communication standard as well as the intent and prior enforce ment actions of the Agency over the last decade under the vinyl chloride standard. Fundamentally, we are only asking that OSHA treat vinyl chloride the same as other carcinogens. Our prior correspondence reviewed the OSHA vinyl chloride standard and subsequent regulatory developments in some detail. In addition, we noted that neither the Food and Drug Administration (FDA) nor the Environmental Protection Agency (EPA) operate under the zero-threshold approach raised during our meeting. PVC is "prior sanctioned" for food contact uses and earlier this year FDA published a proposal reaffirming the safety of PVC for all food contact applications. 51 Fed. Reg. 4,173-41,188 (Feb. 3, 1986). FDA's key specification is a limitation on the amount of residual vinyl chloride monomer permitted in various vinyl chloride polymers and copolymers. The limitations ensure that the levels of vinyl chloride monomer in food contact articles are so low as to pose no health problem. Similarly, EPA's Clean Air Act regulations do not prohibit emissions but seek to minimize them to safe levels. 40 C.F.R. 60.61 et seq. Likewise, EPA has proposed a maximum contaminant level JMCL) under the Safe Drinking Water Act. 50 Fed. Reg. 46,902, 46,930 (Nov. 13, 1985) (proposed Section 40 C.F.R. 141.61). A zero-threshold approach in applying the S PI-03040 Mr. John B. Miles, Jr. August 29, 1986 Page 3 Keller and Heckman PVC labeling requirements would not only be inconsistent with OSHA's prior actions but would also conflict with the regula tory posture taken by FDA and EPA. During the course of our discussion, Mr. Gibbs raised a question concerning the so-called "meat worker's asthma" that at one time was alleged to be caused by the hot wire cutting of PVC film. I am enclosing with this letter the "Final Report for Study of Respiratory Effects in the Retail Food Industry" prepared by the Occupational Health Program at the Harvard School of Public Health (Oct. 4, 1984). The study concludes that there is no statistically significant difference in the pulmonary function between workers who were exposed to hot wire PVC film cutting and those who are not. This is consistent with a number of earlier studies which the authors cite in the beginning of the article. While those earlier studies may have had certain uncontrolled variables, the enclosed study con trolled for those variables and reached the same conclusions as the earlier studies. A separate study by the Southwest Research Institute on the effects of exposure to hydrogen chloride (HCL) further demonstrates that thermal decomposition presents no health threat. Another issue raised during the meeting was the sig nificance of studies involving implanted PVC particles. A memorandum discussing this subject is attached. It demon strates that PVC is not an animal carcinogen and that available epidemiological data are insufficient to classify PVC as a human carcinogen. We trust that the enclosed memo will resolve any questions raised by the Registry of Toxic Effects of Chemical Substances (RTECS). We plan to take independent steps to have the RTECS references to PVC corrected. If OSHA did adopt a zero-threshold position that would require the labeling of PVC as a carcinogen regardless of the amount of residual vinyl chloride monomer, that position would be inconsistent with the basic statutory direction given to OSHA by Congress. Indeed, the Supreme Court stated that the "legislative history also supports the conclusion that Congress was concerned, not with absolute safety, but with the elimina tion of significant harm." Industrial Union Department, AFLCIO v. American Petroleum Institute, 448 U.S. 607, 646 (1980) (benzene case). OSHA has already gone on record to indicate that the training requirements of the vinyl chloride standard SPI-03041 Mr. John B. Miles, Jr. August 29, 1986 Page 4 Keller and Heckman are not applicable when workers handling PVC are not exposed to levels above 0.5 ppm. The Secretary of Labor characterized this situation as "processes which could not result in hazardous exposure to vinyl chloride . . . ." See Secretary of Labor v. Hooker Chemical Co. (OSHRC Docket No. 78-4862). In addition, the courts have long recognized the discretion of regulatory officials to deal appropriately with de minimis situations that present no public health or safety concerns. See, e.g., Monsanto Co. v. Kennedy, 613 F.2d 947, 955 (D.C. Cir. 1979) and cases cited therein. We trust that this additional material, as well as an opportunity to thoroughly consider our earlier submissions, will permit you to provide an opinion letter confirming that: (1) PVC itself is not a hazardous chemical under the hazard communication standard, and (2) vinyl chloride homopolymer and copolymer resins and compounds do not trigger the labeling and training provisions of the vinyl chloride standard when no exposure to vinyl chloride monomer at or above the action level is anticipated. If you are not disposed to take this course of action, we request the opportunity to meet with both the Assistant Secretary for Occupational Safety and Health and the Associate Solicitor for Occupational Safety and Health. If such a meet ing is necessary, the attendees will include representatives from the Vinyl Institute and its member companies with appro priate scientific and management background to discuss these matters fully. I trust that such a meeting will not be necessary, but did wish to advise you that this topic is of great significance to our industry. I look forward to hearing from you. If you have any comments or need additional information, please let me know. Sincerely, Enclosures Peter L. de la Cruz SP1-03042