Document gbdVRMbLOvjNOvXGGYg8kGpRa

J mJmm mmm Vinyl W m Institute A Division of The Society of The Plastics Industry, fnc. March 16, 1987 TO: The Vinyl Institute Health, Safety & Environment Committee RE: Follow-Up Items From March 12-13th Meeting 1. Attached is the material Joe Ledvina gave me at the March 12-13th meeting for distribution. 2. Enclosed is an up-to-date committee roster for your files. 3. This morning Dennis Burgess (Assistant Technical Director of SPI) called to brief me on a meeting of the Science Advisory Board that he attended on March Sth and 6th. As you know, one of subjects on the Agenda for that meeting was the TCLP. Dennis indicated that Matt Strauss was at the SAB Meeting on behalf of EPA. The SAB reportedly expressed concern about a variety of TCLP issues - wastewater, biodegradation, and the generic landfill scenario. The SAB is now reviewing the conments that EPA received, along with a report from the Agency to SAB. (Dennis could not get a copy of this report). The SAB intends to complete their review and formally direct their comments to the EPA in August/September. In the meantime, and of importance, is the fact that Strauss indicated at the SAB Meeting that the Agency would indeed be reopening the comment period in the very near future. I will send you a copy of Dennis' memo on this subject as soon as I receive it. As soon as the notice is officially published in the Register, I will apprise you. MNS/pmb enclosures Meredith N. Scheck Assistant Director VVV 000004285 Wayne Interchange Plaza if 155 Route 46 West Vfeyne, NJ 07470 (201) 890-9299 Emergency and Continuous Exposure Guidance Levels for Selected Airborne Contaminants Volume 6 " Benzene and Ethylene Oxide Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council 00oo^a 6 * .'** bise S^^c^iwaJ *,rl fc.r.vo^Alirj^ac^'A ^ ----a-- .-....- serf n^orr : APPENDIX " -,v '" ' t-i EEGLs FOR CARCINOGENS -V* i rr. '"' : :? : "-? .-/' " rT r: **; ..Vr.**-.' s.sl5a 9 S': n; ?..*' .':- ' * . - . When a. substance under evaluation Is an animal or human carcinogen, a - separate quantitative risk assessment is undertaken in recognition of the fact /that even limited exposure to such agents can theoretically "> increase-the`risk of cancer>(Office of Science and Technology Policy,'- 1985):ri^|^'r-T.--T'^ ":?*'.4*? :r-*^^ - : :-? Estimating EEGLs for chemical carcinogens Is complicated. Vainio et al. (1985) extracted data from the first 38 volumes of IARC Monographs on chemicals and exposures for which some data on carcinogenicity in humans or. sufficient evidence of carcinogenicity in experimental animals existed. * In all,-288 chemicals, industrial processes, and complex mixtures fulfilled these criteria. For 30 m chemicals or mixtures of chemicals and nine industrial processes, there was sufficient evidence of carcinogenicity in humans; and for 63 chemicals and mixtures of chemicals and five industrial processes, there was evidence that these'exposures were probably carcinogenic to humans:""For 61 chemicals or groups of chemicals and six industrial ,b processes or occupationsno evaluation of carcinogenicity to humans " could be madel For 115 chemicals, there is sufficient evidence of carcinogenicity to experimental animals, but no epidemiologic data are available. Many experimental investigations involve high-dosage, longduration exposures Co compensate for the small number of animals that are used. Data on short-term or single exposures are virtually - nonexistent. Substances that are carcinogenic in one mammalian species are often carcinogenic in another; species differences in metabolic capacities sometimes account for less than perfect correlations. Further studies are needed to establish which species most closely approximate humans. It would not be surprising to find that this is different for different chemical classes. ' Quantitative data from humans ace -sparse^. In the absence of human data, it is usually assumed that carcinogenic risk derived from animal data is directly and at least quantitatively applicable to humans. Extrapolation from high-dose animal exposures to low-dose human exposures is often required, and this involves many uncertainties. The shape of tile dose-response curve at low doses is generally unknown, especially below the 1% tumor-response range. Repair rates, possible nonlinearities, and other factors Involved in low-dose studies are not available. Variations in personal habits. -69- VVV 000004287 disc, other exposures, intercurrent disease, and age at lrst exposure contribute additional uncertainties in predicting human effects, - Mathematical models suggest greater precision Chan exists. The role of short-term exposures in producing cancer is not clear. On the one hand, any exposure to s carcinogen has the potential to add to the probability of carcinogenic effects, and such exposure should be avoided or at least minimized. Nitrosoureas, for example, are carcinogenic after a single exposure, and hydrazines and other alkylating agents might also have this capacity. On the other hand, the effects of long or repeated exposures could greatly overshadow - brief exposures (up to 24 h). Industrial accidents involving brief exposures to vinyl chloride or benzidine might be in that category. A familiar example of strong relation of cancer risk to duration of exposure is tobacco-smoking. Exposure to tobacco products for a day or less, although not carrying zero risk, carries much less risk than chronic smoking and will not be likely to add significantly to the risk of tobacco-related cancer. .. The following mathematical approach la applicable fox EEG1 . - . - t - * computations for carcinogens. 1. If an exposure d (usually in parts per million in air) has been computed that, following a lifetime of exposure, is estimated to produce some "acceptable* degree of excess risk of cancer--say, 1 x 10` --this has been called a "virtually safe dose" (VSD). Dose d, If not already computed by a regulatory agency, will be computed by COT in accordance with generally accepted procedures used by the major regulatory agencies--i.e., with the multistage no-threshold models for carcinogenesis and the appropriate body weight/surface area adjustments for extrapolating from an animal species to humans. 2. If carcinogenic effect is assumed to be a linear function of the total (cumulative) dose, then for a single 1-day human exposure an acceptable dose (to yield the same total lifetime exposure) would be d x 25,600 (there being approximately 25,600 days in an average lifetime) , and the allowable one-day (24 h) dose rate would be d x 25,600. 3. Because of uncertainties about which of several stages In the carcinogenic process a material might operate in and because of the likely youth of military persons, it can be shown from data of Crump and Howe (1984) that the maximal additional risk than these considerations contribute is a factor of 2.8. As a conservative approach, the acceptable dose Is divided by 2.8, i.e., : y- If a Jifetime excess risk, R, is established by D0D (for example at 1 x 10 , as has been suggested by the International Council on -70- OOG0042SB VVV tf. Radiation Protection for nuclear power plant workers) appropriate EEGL-based risk would be then the . *" d x 25 J>00 * R_ _ 2.8 risk at d (In the example given here, the risk at d was no more chan 1 x If R is 1 x 10`4, then R(risk at d) - 10*4/10"6 - 100. 4. If a further element of conservatism is required (for example, if animal data need to be translated to human risk) , an additional safety factor can be used as a divisor. The assumption that the carcinogenic response is directly proportional to total dose is likely not to hold for all materials and all tissues that these materials affect. Appropriate mathematical models need to be developed for materials that have other mechanisms for the induction or promotion of cancer. Thus, if a proto-oncogene needs to go through several mutations before It is "turned on" to producing frank cancer cells, the material that leads to the final imitation might show a higher-degree dose-response function than the ' ; ^ material producing the first-stage mutation. Knowledge of mechanisms * that produce different dose-response curves should, in the future, lead to better material- and mechanism-specific risk-assessment computations. -- REFERENCES Crump, K.S., and R.8. Howe. The multistage model with a time-dependent dose pattern. Applications to carcinogenic risk assessment. Risk Analysis 4:163-176, 1984. Office of Science and Technology Policy. 1985. Chemical carcinogens. A review of the science and its associated principles. Fed. Regist. 50: 10372-10442. Vainio, H., K. Hemninki, and J. tfilbourn, 1985. Data on the carcinogenicity of chemicals in the IARC Monographs programme. Carcinogenesis 6:1853-1665. -71- V'VV' 000004289 TABLE I BENZENE CHLORINE ETO HC1 HF VCM CRITERIA LEVELS FROM THE LITERATURE FOR SELECTED CHEMICALS PEL/TLV STEL IDLH*(K1)J 10ppm(30mg/$3)PEL lOppm lppm 7 3 lppm(3mg/m ) (ceiling) lppm (a lppm(2mg/m ) lppm TLV NIOSH PEL TLV PEL TLV 50ppm 25ppm None 3ppm(9mg/|rp3) None r* None 5ppm(NIOSH) 2,000ppm 25ppm 800ppm 5ppm(7mg/m^) (ceiling) 5ppm (ceiling) PEL TLV None None lOOppm 3ppm(2.5mg/m3)PEL 3ppra (ceiling) TLV 6ppm(5mg/u ) None 20ppm 1,0ppm(3mg/m^lPEL 5.0ppm(15mg/ni )TLV 5ppm None None Found NRC/EEG*(2) 1,000ppm 3ppm 20ppm NOTES: (1) IDLH is defined by NIOSH as the 30 minute maximum concentration from which one could escape without escape imparing symptoms or any irreversible health effects. (2) NRC/EEG - These are the levels proposed, or recommended by the National Research Council, committee on Emergency Exposure Guidelines. There are considered as a ceiling limit for a one time exposure, not to exceed 60 minutes. Comments: In general ceiling limits are "not to be exceeded" limits for industrial workers. They would be conservative estimates for the normal population. HF, HC1, and Chlorine are all detectable and potentially irritating at levels of 1/(B to 2 times the PEL/TLV. X 009/PED16 VVV 000004290 V HEALTH, SAFETY & ENVIRONMENT COMMITTEE Charleston Marriott Hotel North Charleston, South Carolina Board Room I Thursday December 18, 1986 9:00 a.m. Attendees: W. C. Holbrook, Chairman J. King J. Kachtick J. Ledvina F. Borrelli N. Blackman C. Graybill M. Scheck - BFGoodrich - Occidental Chemical - Occidental Chemical - Vista Chemical - Georgia Gulf - Borden Chemical - PPG Industries - Vinyl Institute Companies Not Represented: Air Products and Chemicals Dow Chemical Company CertainTeed Corporation Approval of Minutes of October 8, 1986 Meeting Mr. King motioned that the minutes of the previous committee meeting be approved without correction. The motion was seconded by Mr. Kachtick and approved by voice vote by those present. Legal Update On behalf of counsel, Ms. Scheck updated the committee on the legal status of the VCM standard. Ms. Scheck disseminated a report prepared by Mr. de la Cruz as well as copies of the November 20, 1986 General Counsel Report to the Vinyl Institute Executive Board. THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 355 Lexington Avenue New York. N.Y. 10017 (212) 503-0600 VVV 000004291 Health, Safety & Environment Committee Meeting Minutes December 18, 1986 Page Two RCRA Update: TCLP Mr. King noted that responses to his questionnaire on sending samples to an outside laboratory for analysis were "mixed". Of those who responded, one company responded in the affirmative, two in the negative, and two willing to go along with the majority of responders. As part of the discus sion on individual company experiences, it was noted that results of using the TCLP on products differ substantially and that there have been numerous problems in trying to use the specified method to achieve verifiable results. Two companies noted that they have received customer inquiries and suggested that other companies may soon receive similar requests. RCRA VI Task Force Mr. Kachtick noted that the task group assigned at the October 8th meeting to provide input to the Vinyl Institute Legal Committee for filing of com ments met in Houston. Kachtick noted that with the assistance of Bailey Barton of Borden, material was provided to the Legal Committee. Addition ally, Kachtick noted that there is no indication that further assistance is needed. Enforcement Update Mr. Kachtick noted that Texas Air Control Board staff has been considering the viability of working on a proposed matrix that would correlate air violation and fines per violation. Messrs. King, Ledvina, Graybill and Holbrook updated the committee in pending legal activity. PVC Waste Disposal Subcommittee Mr. Ledvina reviewed the background on the issue of vinyl chloride in groundwater near landfills. Additionally, he noted that the survey questionnaire on the issue was disseminated to VCSA members and that the results of the survey were presented at the October 1986 Annual Meeting of the VCSA. Ledvina further noted that the results of the survey do not point to the need for more work on the issue at this time. EPA Survey Mr. King reviewed the background of a discussion at the December 10th Vinyl Institute Executive Board Meeting relative to the preparation of an industry survey on the industry performance record under NESHAPS and the increasing cost penalties. Ms. Scheck noted that the Executive Board agreed that a meeting with EPA policymakers would be a worthwhile project to be under taken. After lengthy discussion,, the committee uniformly agreed that VVV 000004292 Health, Safety & Environment Committee Meeting Minutes December 18, 1986 Page Three recent enforcement activities relative to NESHAPS was but one part of the problem. It was noted that when one considers the TCLP and the use of the California list among other regulatory initiatives, that the industry is being "nitpicked". It was suggested that rather than pursuing a survey on NESHAPS alone, that a strategy session involving HSE and Legal Committee representatives should be pursued at the earliest possible time. It was noted that such could occur on the afternoon of the 13th, if schedules permitted. HOC; Land Ban Disposal Mr. Holbrook noted that EPA published in the December 11, 1986 Federal Register a proposed rule on "Hazardous Waste Management System: Land Dispos al Restrictions". He said that the proposed rule states that it was not EPA's intention to include PVC, but that they are specifically seeking comments on this approach. Holbrook urged and the committee agreed that the Vinyl Institute should plan to testify at the January 14th Agency public hearing and file written comments by the January 28th deadline. Following a review of the proposal and a lengthy discussion the Committee: a. decided that the Vinyl Institute, represented by the Health, Safety and Environment Committee Chairman, W.C. Holbrook, should appear at the EPA public hearing; b. agreed that the Vinyl Institute should also submit written comments; c. decided that a subcommittee would meet on January 12th and 13th to prepare comments, and d. developed the following list of key points to serve as the basis of the Vinyl Institute comments: - enormous waste volume. - inadequate incineration capacity. - incineration generates additional hazardous waste and TDS. . - chlorine (from environmental view) is better in bound form. - safety uses of PVC. - studies show landfill disposal to be environmentally sound. - PVC not carcinogenic. - refer to previous industry comments on TCLP. - use and status of California list. wastewater Ms. Scheck will send a notice to the committee on the above and ask them to compile data on PVC and PVC sludge generation and disposal. (Note: This was done by separate memo dated January 5, 1987). Also, Scheck to notify Agency of Vinyl Institute intent to appear at the January 14th hear ing. Holbrook agreed to inquire regarding CMA position. VVV 000004293 Health, Safety & Environment Committee Meeting Minutes December 18, 1986 Page Four NESHAPS The committee discussed several items related to EPA NESHAPS' enforcement and guidance activities. Specifically discussed were the definition of EDC purification and the inclusion of crude intermediate storage tanks to 10 ppm. Holbrook noted that he has been trying to clarify with EPA the discrepancy that exists between #4B8 in the BID and the standard. He noted that Mr. Dimmick of EPA has sent him additional documentation which is currently being reviewed. The committee also discussed EPA's interpretation of a "process unit" and reviewed contacts between individual companies and the Agency. Lastly, committee members reviewed in a roundtable discussion, their company submissions to EPA on material required to be submitted under NESHAPS. CERCLA Mr. Blackman distributed and reviewed material that Mr. Barton had previously agreed to present relating to provisions of CERCLA. Committee members discussed their experiences with CERCLA. Mr. Kachtick noted that a CMA workshop on CERCLA and Right-To-Know is scheduled to be held on January 28, 1987. The committee agreed that at a future meeting the agenda will include a roundtable discussion on the provisions of "federally permitted". Proposition 65 Mr. Ledvina noted that the Governor of California is slated to release the required material under the recently adopted Proposition 65 in March 1987. The committee noted that at the present time, interpretations regarding the provisions of the adopted proposition differ significantly and, therefore, the impact is uncertain. Committee members agreed that this subject be included on the agenda for the next meeting. New Meeting/Adjournment It was agreed that unless otherwise necessary, the next full committee meeting will begin at 12 noon on March 12th and conclude at 12 noon on March 13th. The first choice location was Key West, Florida or Fort Lauderdale. The second choice noted for a future meeting was San Antonio, Texas. There being no other business, the meeting was adjourned at 2:00 p.m. Respectfully submitted, VVV 000004294 v