Document MMDZjZZKGox1VnjJXBq64erx

<.0 1\{- * 1 py F f */r,/r L M I N E R A L S & C H E M I C A L S D I V I S I O NE N 0 R L H A R D M I N E R A L S & C H E M I C A L S C O R P O R A T I O N 1 MENLO PARK EDISON, N6W JERSEY 08617 CABLE ADDRESS: MICDR ?i / - 'y ?# March 9, 1979 Mr. Frederick F. Roesch, Executive Vice President Whittaker, Clark & Daniels, Inc. 1000 Coolidge Street South Plainfield, NJ 07080 Dear Mr. Roesch: Enclosed is a copy of the cover letter outlining our initial response to the proposed Talc Exposure Criterion Document. This letter was sub mitted to Dr. Romero, along with extensive documentation and answers to the questions from N.I.O.S.H. This is an important issue for the talc industry, and one where cooperative effort may be essential. JMZ/mlp enc. PLAINTIFFS EXHIBIT WCD-172 WCD 001598 MINERALS & CHEMICALS DIVISION ENGELHARD M-NERALS A CHEMICALS CORPORATION M E N L . O P A R K O S O N , N E W J E R S E Y o 8 , : ? R O B E R T M.Mf.iuvAi VU t P H l S l I d Hi January 22, 1979 Mr. Anthony Romero, Criteria Document Manager Division of Criteria Documentation and Standards Development, NIOSH, Room 8A-37 5600 Fishers Lane Rockville, Maryland 20852 Dear Mr. Romero: Our critique of the first draft of the "Criteria for a Recommended Standard - Occupational Exposure to Talc" dated October 1978 is submitted with this letter. It is based on an intensive review by Engelhard's staff and by qualified independent authorities. From a careful study of the draft Criteria Document and its supporting documents, it is readily apparent that the pertinent facts regarding the hazard or lack of hazard from workplace exposure to talc have yet to be properly defined. This is especially true for the non-asbestiform, quartz-free talc which is mined and processed in our Vermont operations. In addition, there is no justification for including asbestos-free talc in the hazardous labeling and posting proposals in the draft document. The studies relied upon in the draft Criteria Document do not accurately measure the exposure effects or define the type of talc under examination. In the absence of reliable information derived from soundly designed studies that state accurately measured exposure effects of precisely defined talcs on physiological changes, it is both premature and unwarranted to recommend a new exposure limit.* In addition, no basis is presented for a 0.1 mg/in limit that equates the hazard of talc with that of free silica (alpha quartz) and implies that talc is twice as toxic as coal dust (TLV 0.2 rng/ni ). There Is no evidence that anyone who uses existing good practices when working with asbestos-free, quartz-free talcs, Is in any danger. On the contrary, the data underlying the reports of Wegman and Selevan, when fairly analyzed, fully supports Engelhard1s position that the existing exposure limits are more than adequate. WCD 001599 MINERALS & CHEMICALS DIVISION Mr. Anthony Romero, Criteria Document Manager Division of Criteria Documentation and Standards Development, NIOSH, Room 8A-37 January 22, 1979 Page 2 We urge NIOSH, with the full cooperation of Engelhard and other producers and users of talc, to initiate thorough, properly designed studies to establish conclusively the nature and extent of any hazards, and thereby determine appropriate safe occupational exposure limits for talc. Rather than publish a Talc Criteria Document which is sure to be challenged, we ask that you lead a cooperative effort to produce a standard that leaves little room for argument and one which results in the definition of truly safe levels of exposure, thus affording appropriate protection to talc workers. In the absence of definitive toxicity, epidemiological and workplace studies, no change can be Justified in the present limit for talc exposure. Attached for your study are our detailed comments and recommendations in support of our critique. The first of these presents our responses to the thirteen questions which were addressed to the official external reviewers. The other attachments deal with certain key references and other issues we feel NIOSH will need to consider further. We also ask that NIOSH consider two matters not dealt with in the questionalre, but needed to evaluate the impact and utility of any proposed workplace procedure. 1. Given the diversity of workplaces where talc is used, cannot a procedure be developed for exempting locations where the total amount of talc will be small, and the incidence of airborne talc episodic. If exemption is not practical, then we would urge that a variety of procedures be permitted allowing flexibility in attaining workplace goals. 2. Everyone would benefit if NIOSH would devise a reasonably simple, foolproof system for measuring and characterizing the actual pure talc in the environment rather than measuring gross particulate quantities in the air and applying some assumptions v WCD 001600 MINERALS & CHEMICALS DIVISION &b Hr. Anthony Romero, Criteria Document Manager Division of Criteria Documentation and Standards Development, NIOSH, Room 8A-37 January 22, 197*9 Page 3 as to the identity of the material collected. It is unrealistic for asbestos-free talc to take the rap for other materials present in one degree or another. We need a consensus on the measuring techniques to be applied, especially where NIOSH is recommending radical, but certainly warranted, alterations from past sampling methods. We appreciate the opportunity you have given us to present our views and analysis of the Criteria Document. Please let us have copies of the next draft as soon as it is available, and let us know what the schedule is for subsequent reviews and discussions. We assure you of Engelhard*s continuing desire to cooperate in all possible efforts to maintain safe, healthy working conditions in all its operations. Robert M. Mcllwaih Vice President - Administration /fj Att WCD 001601 INDEX TO APPENDIGES ATTACHED TO THE CRITIQUE OP FIRST DRAFT "CRITERIA FOR A RECOMMENDED STANDARD- - OCCUPATIONAL EXPOSURE TO TALC" DATED OCTOBER 1978 A - Responses to External Review Questions B - Critique of Medical Assessment Section by Dr. R. C. Kory C - Critique of Sputum Cytology as a Diagnostic Procedure by Dr. J. W. Clayton D - Critique of Fine et al Reference by Dr. H, A. Lewis E - Critique of Fine et al Wegroan et al References by R. L. Kolesar and T. D. Oulton F - Critique of Selevan et al Reference G - Critique of Animal Toxicity Section by Dr. J. W. Clayton January 22 t 1979 MINERALS & CHEMICALS DIVISION ENGELHARD MINERALS & CHEMICALS CORPORATION MENLO PARK, EDISON, N. J. 08817 WCD 001602