Document gaVgJazMEOLKx5Kq5RJ1jJVgq

The Society of the Plastics Industry, Inc. 355 Lexington Avenue New York, New York 10017 (212)573 9400 July 7, 1980 TO: THE PVC SAFETY GROUP Gentlemen: Based on the ballots returned to the S?I office which represented a majority of the member companies, the new officers of the PVC Safety Group for the period June 1, 1980 to May 31, 1981 are as follows: Chairman - Dr. A. Ross Adams Air Product^ & Chemicals P. 0. Box 53%^.^ ..;,. Allentown, PA "18105 Vice Chairman - Monte Eaymon Tenneco Chemicals, Inc. P. 0. Box 365 Piscataway, HJ 08854 Treasurer - Gregg Lazarchik PPG Industries One Gateway Center Pittsburgh, PA 15222 Members of the Steering Committee for three year terms commencing May 31, I960, are: Tenneco Chemicals Borden Chemical Corporation PPG Industries Very truly yours. JRL:gp j ~ 'J John R. Lawrence Technical Director A - - 0 *1 RECEIVED h.s. & e support INFORMA h ;,m 5 l:'r '. I ''. The Society of the Plastics Industry, Inc. 355 Lexington Avenue New York, New York 10017 (212)573 9400 July 7, 1930 TO: THE PVC SAFETY GROUP FROM: John R. Lawrence Technical Director RE: NCI REPORT(wC 54386) On June 28 the Board of Scientific Counsellors operating under the National Toxicology Program reviewed the dioctyl adipate plasticizers study (NCI Report #C54386) . This report concludes that the materials are carcinogenic to male mice under the conditions of test exposures. ^ Since these findings are now public information, it behooves all users of the materials to consider any hazards to workers or consumers who may be in contact with the materials. From a regulatory pers pective it is felt that the first agency that may feel compelled to act on this report is the Food and Drug Administration because of the zero risk mandate of the Delaney Clause. In reviewing this with the PVC Safety Group's Chairman, Dr. Ross Adams, we concluded that the Group should be informed of these findings immediately and respond to the following questions: . (1) Do you believe that there is a need for an emergency meeting of the Group with interest in this area? (2) Are there toxicology data available which might refute the findings of the NCI study? We would appreciate your answers to either or both of these questions as soon as possible. If there is to be a meeting on this subject we will plan on scheduling it for early August and notify you accordingly. see - 15 - EPAt USDA And FDA Jointly Issue Regulations Prohibiting PCB-Containing Equipment tn Food Packaging Materials Plants The United States Department of Agriculture's (USDA) Food Safety and Quality Service (FSQS), FDA and EPA published proposed rides in the Federal Register on May 9, relating to products containing polychlorinated biphenyls (PCB's). The EPA and FSQS proposals are directed towards pesticide and USDA inspected establishments and are not directly relevant to our general interests. FDA's proposal, however, is of great concern to SPi members. The major thrust of the FDA regulations is that transformers and con densers in plants that manufacture food, feed, and food packaging materials con taining PCB's (except for condensers weighing less than three pounds) must either be removed or retro-fitted to replace the PCB-containing dielectric by a safe replacement. To the extent that accidents have occurred in food and feed manufacturing plants leading to PCB contamination, this retro-fitting require ment may be justified. On the other hand, applying this requirement to plants that manufacture plastics food packaging materials where no problems have ever arisen (and . where none seem likely to occur) appears to be another example of regulatory over-kill. A major question which needs "To^be addressed by these proposals concerns the definition of a food packaging-materials plant. Many plants manufacture intermediates, some of which may ultimately be used in plas tics packaging materials. Others manufacture plastics for general purposes, and among these purposes may be their use for food packaging. The question as to whether such plants will be considered to be food packaging materials manufac turing plants needs resolution. Plans are being made to advance the industry's position on this matter in formal comments. In a related matter, there is still no word fpdm EPA on SPTs requested exemption for colorants containing 50 ppm or greater PCB's. In the absence of such an exemption, these colorants would be prohibited under rules published on May 31, 1979, in accordance with the Toxic Substances Control Act (TSCA). If it should become necessary, even though the initial exemption request is still pend ing, we are preparing to obtain a one-year renewal of the exemption request. /' QSHA Requests Information On Vinyl Chloride And Polyvinyl Chloride On December 18, 1979, OSHA published a Federal Register Notice re questing information on health effects of vinyl chloride and polyvinyl chloride. According to OSHA staff, this request was merely for purposes of providing a complete record of related research carried out since 1975 and should not be re garded as an Advance Notice of Proposed Rule Making. 4 - 16 - Despite such reassurances, however, this Notice was not taken lightly by the PVC Safety Group, since the "update" would put the Agency in a position to reevaluate the adequacy of OSHA's current standard for vinyl chloride, could serve to support a rule making on PVC dust, and could have political impact in many other ways, e.g., on our current efforts to completely clear PVC with FDA and obtain a BATF blessing for the reinstatement of the PVC liquor bottle. It is our understanding that OSHA's Notice was prompted by particular concerns with regard to cancer at sites other than the liver, evidence of animal toxicity at lower levels of exposure to vinyl chloride monomer (VCM) and the possible carcinogenicity of PVC dust. OSHA also purports to have information demonstrating that vinyl chloride is both mutagenic and fetatoxic in humans and that exposure to PVC dust may effect the respiratory and central nervous sys tems. \ In addition to the publication of the Request for Information (RFI), OSHA held a "Conference to Reevaluate the Toxicity of , . . Vinyl Chloride, Polyvinyl Chloride and Structural Analogues" on March 20 and 21, 1980, which we attended. In general, this symposium provided no information not previously known to both OSHA and industry. We are, therefore, hopeful that the Agency's concerns will be resolved without need Cor further regulatory action. Nonethe less, responsive to the RFI, the PVC Safety Groug^filed extensive comments based on the papers presented at the symposium. ^ ^ '.... Hazard Assessment Issued on Styrene We recently learned that the National Institute of Occupational Safety and Health (NIOSH) has issued a hazard assessment on styrene, recommending a time-weighted average (TWA) of 25 ppm and a 100 ppm ceiling. The extensive ness of this document is significant since the Institute does not usually make specific recommendations on safe exposure levels for a substance under review. From what we have learned through talking with NIOSH staffers, the Agency itself is confused about the final form that this document will take and uncertain about the impact it will have at OSHA. Not having seen a copy of the assess ment, we are unable to go into much more detail at this point; by the time of our meeting we should know more about the specifics. / Meanwhile, we are still awaiting formal release of NIOSH's criteria document on styrene. Unexpectedly, NIOSH Director Dr. Anthony Robbins re quested a meeting with the Reinforced Plastics/Composites (RP/C) Institute of SPI on February 21, 1980. For some time now, industry has asked for such a meeting but was repeatedly refused. We were therefore uncertain about what to expect from this overture, although we suspected that it might be related to the formal release of NIOSH's criteria document for styrene. - 17 - The outcome of this meeting was not quite what we had expected. In essence, NIOSH was more interested in what the RP/C Institute is doing in terms of studies than in discussing exactly what the Agency itself was planning to do. While industry representatives were left with the impression that the Criteria Document is "ready to go," NIOSH officials left the details about its release (Le., how and when) much in doubt. Although we learned little about the status of the Criteria Document as a result of our session, the meeting proved beneficial in other ways. The staff was exceedingly interested in the progress of the mortality study and in the technology investigations being conducted by industry. In fact, SPI representa tives were asked to supply the technology study reports to NIOSH as soon as they are completed. Additionally, the industry has been able to show NIOSH that it is acting responsibly vis-a-vis worker health.