Document bVdwaDv0KbrJemvR022w0KRg

JOSEPH E. KELLER JEROME H. HECKMAN CHARLES M MEEHAN WILLIAM H.BOHGHESANI, JR, ROBERT R.TIERNAN WAYNE V. BLACK DAVID L. HILL MARTIN W. BEHCOVICI PETER M. NEMKOV JOSEPH E*HADLEY CAROLE C. HARRIS PETER THOMAS SMITH MICHAEL F. MORRONE LARRY S. SOLOMON LAW OFFICES Kelleh and Heckmant 1130 1TTB STREET, E, W, SUITE tOOO WASHINGTON, D. C. 20036 April 2, 1976 No. 19 W. A. K. APR 01976 TELEPHONE BOS 896-2100 CABLE ADDBESS "EELMAN" TO: All Members of VCM/PVC Mailing Lists Ladies and Gentlemen: The major purpose of this letter is to bring you up-to-date regarding this week's Occupational Safety and Health Administration (OSHA) developments since, as you know, April 1, 1976 was the date when the full requirements of OSHA's Vinyl Chloride Standard went into effect. In addition, we do have a few comments regarding the situation at the Food and Drug Administration (FDA). With respect to the Environmental Protection Agency (EPA), through Mr. Ruckelshaus' office, contact is being maintained with the Agency but there is nothing substantive to report at this time. OSHA In anticipation of the April 1, 1976 end to the provision providing for the discretionary use of respira tors by workers exposed to levels of more than 1 ppm but less than 25 ppm vinyl chloride monomer, and predicated on the lack of availability of suitable respiratory pro tection equipment, a number of companies requested that the Occupational Safety and Health Administration (OSHA) grant them temporary variances from the Standard for Occupational Exposure to Vinyl Chloride. It has now be come apparent that the "unavailability of suitable equipment" argument has been mooted, at least until next Fall. ASI 000015162 April 2, 1976 Page Two More specifically, in yesterday's Federal Regis ter, the Mining Enforcement and Safety Administration (MESA) of the Department of the Interior announced a retroactive extension to September 30, 1976 vis-a-vis the previously established December 31, 1975 deadline for development and use of an end-of-service-life indicator for canister and cartridge respirators in vinyl chloride service. Failure in the development of the requisite indicator had, at least in theory, made use of canister and cartridge respirators inadequate for compliance with the OSHA Stand ard during 1976; only air-supplied respiratory protective devices were approved. With MESA on its own motion having extended the deadline for the end-of-service-life indicator requirement, the resultant canister and cartridge mask availability will probably make it possible for OSHA to deny or delay action on all requests for variances. At least thus far, to the best of our knowledge, none of them have been granted so the wearing of respiratory protection devices by personnel exposed above the 1 ppm TWA level is now mandatory. FDA Before discussing anything else, we are anxious to correct an error in our last letter. On the first page of that communication, we erroneously indicated that Dr. John Stafford of Imperial Chemical Industries, Ltd. had replaced Barry Barnes as Chairman of the European Council of Chemical Manufacturers' Federations (CEFIC) Committee for the Toxicity of Vinyl Chloride. While Dr. Stafford was our visitor, and has assumed some of Barry Barnes' duties at ICI, the new Chairman of the CEFIC vinyl chloride committee is Dr. Werner Freiesleben of Wacker Chemical in West Germany. We apologize to our good friends in Europe and hope this note will serve to "correct the record" adequately. We are continuing to stay in touch with the FDA Staff as the review of the submitted Comments proceeds. The technical review has not yet been fully completed so no draft of final Regulations has been started. Conse quently, the target date for a final Regulation, i.e. in the second quarter of this year, while not unattainable, begins to look somewhat more improbable. 000015163 AS I April 2, 1976 Page Three It is our understanding that the joint Task Force set up between FDA and EPA to explore jurisdictional prob lems relative to water distribution systems matters, among others, has been somewhat active but we have no hard intelligence on what, if anything, is being accomplished. Since this "group" is considering many other problems than the one of direct concern to us, i.e. jurisdiction over PVC potable water piping systems, we believe it fair to say that issue has not really been joined on this question. We are providing input on the subject and will let you know when we have anything firm to convey. With respect to PVC pipe, we have learned that EPA scientists have submitted a paper for publication in the American Water Works Association Journal which details the results obtained in the EPA tests using a closed loop in its Cincinnati laboratories, and the results of field studies in five communities. These results have already been filed in the FDA Docket but it is anticipated that the publication will now present details about the pro cedures and open them to peer scrutiny. Our advice is generally to the effect that EPA has concluded that installed PVC systems pose no public health problem with respect to vinyl chloride migration but the Agency intends to add vinyl chloride to its regular list of substances for which it monitors the water supply. *** As in the past, we shall continue to inform you as fully and promptly as we are able with respect to all the various aspects of the VCM/PVC matter. AS I 000015164 RULES AND REGULATIONS 13919 Health, Education, and Welfare adopted special procedures for testing and ap proval of respirators used against ex posure to vinyl chloride <39 FR 45012), ALso adopted, with a delayed effective date, was a requirement that any can ister or cartridge used to protect em ployees against exposure to this sub stance have an ead-of-service-life in dicator. Section UJOSia) of Title 30, Code of Federal Regulations, provides that after December 31,1975, a cartridge or canister without an end-of-servicelife indicator will not be considered ap proved for use by employees exposed to vinyl chloride. The purpose of the amendment set forth below is to extend the December 31, 1975, deadline date until September 30, 1976. This action is considered neces sary because there are no respirators with an end-of-service-life Indicator presently approved for use against ex posure to vinyl chloride, and It is essen tial that the currently approved respira tory devices continue to be available for this purpose. While the Indicator is an additional safety feature, the extension is not expected to adversely affect worker health provided currently approved res piratory equipment is used as directed. The Government has received only one application for approval of a respirator with an end-of-service-life indicator. When approval Is issued, the manufac turer will require, and the extension will provide, sufficient lead time for the pro duction of the respirators necessary to supply exposed workers. The Occupational Safety and Health Administration of the Department of Labor, which Is charged with the en forcement of occupational standards, has advised that It concurs with the granting of this extension of time. Under the circumstances, the Depart ment finds that good cause exists for omitting notice of proposed rulemaking and opportunity for public participation In the rulemaking which extends the date. Therefore, 1 11.205 Is amended as set forth below, effective December 31, 1975. Dated: March 26,1976, William L. Fishes, Assistant Secretary of the Interior. Dated: January 28,1976. I PR DOC.7G-93S1 Plied 3-31-76;B;45 Am) Title 3^--Mineral Resources CHAPTER I--MININS ENFORCEMENT AND SAFETY ADMINISTRATION, DEPART MENT OF THE INTERIOR PART 11--RESPIRATORY PROTECTIVE DEVICES; TESTS FOR PERMISSIBILITY; FEES Respiratory Protection Against Exposure to Vinyl Chloride; Extension of Time On December 30, 1074, the Secretary of the interior and the Secretary of 11.205 David Mathews, Secretary of Health, Education, and Welfare. [Amended] In the last sentence of paragraph (a) of { 11.205, the date reading "Decem ber 31. 1975", Is changed to read "Sep tember 30, 1976." (Ska. 202(b). 304, 80S. S3 Stat. 7S3, 734, 803 (30 U.C. 842(h), 844. 967); see*. 9, 3, 5, 38 3tit. 370, as Amended; 37 Stat. 861 (30 O.8.C. 3. 3, 7); AC. 8(g), 84 Stat. 1800 (29 U.S.C. 667(g)).) [FR Doc.76-8296 Tiled 3-31-76;8;43 Am) FE0E8AI REGISTER, VOL 41, NO. 84--THURSDAY; APRIL 1, 1976 ASI 000015165