Document em6bYdnO2Xb8MewqmXLd1myqe

. Report to CMA - Special Project Advisory Group January, 1981 by Benzene Special Program Panel C. W, Smith, C. R. Stac* DO OONF tofn-h*- YZ0024290 CHARTER OF THE BENZENE PROGRAM PANEL Consistent with CMA practices and policies, the Benzene Program Panel will represent the interests of the members of the Chemical Manufacturers Association (CMA) before federal and state agencies in all matters relating to safety and health issues arising out of the production, rea'ction, release, packaging, repackaging, storage, transportation, handling or use of benzene. The Panel may support and direct research and studies to expand the data base on matters relating to benzene safety and health issues. The Panel functions as a special committee under CMA's bylaws. As such it is fully subject to the "qeneral principles applicable to the structure and operations of committees". The Panel is subject to CMA's advocacy policy and appropriate coordination and control by CMA's president, staff, and executive committee. DO 060498 00NFTDFNTTA1 YZ0024291 CHARTER OP THE PROTOCOL SUBGROUP OF THE TOXICOLOGY RESEARCH TASK GROUP OF THE BENZENE PROGRAM PANEL Operating within the charters of the Benzene Program Panel and the Toxicology Research Task Group (TRTG) the protocol subgroup will recommend to TRTG the protocol design for the toxicology research specified by TRTG and monitor its progress. CHARTER OF THE TOXICOLOGY RESEARCH TASK GROUP OF THE BENZENE PROGRAM PANEL The Toxicology Research Task Group (TRTG) operating within the charter of the Benzene Program Panel, will provide expert interpretation of available data on the toxicology of benzene and advise the Panel on appropriate research required to expand the toxicological base. TRTG will provide the necessary protocol design or protocol review and will conduct or make provisions for appropriate monitoring and auditing of funding toxicological research. Each company shall have one vote. DO 068499 OONFTDFNT TAI YZ0024292 CHARTER OF THE EPIDEMIOLOGY TASK GROUP OF THE BENZENE PROGRAM PANEL Within the Charter of the Benzene Program Panel (Bpp) the Epidemiology Task Group (ETG) will represent the Panel in the resolution of technical questions concerning the study under contract with Tabershaw Occupational Medicine Associates/ P.A. (TOMA) and will seek Benzene Program Panel responses to alternatives recommended by the TOMA. The ETG will provide stimulus to TOMA to expedite its obligations to complete this study appropriately and in a timely manner. The chairman of the Task Group, or his designee, will be the contact person for TOMA regarding the technical aspects of this epidemiology study. All contractural matters will be handled directly by CMA staff. The Task Group will cease to exist when TOMA has properly completed all obligations in its contract with the CMA for this study, or at the discretion of the members of the Panel. o0 oabfoo CONF10FNTTAV YZ0024293 OCCURRENCE AND USES Besides the small amount of benzene that occurs nat urally in petroleum, commercial production processes in the U.S. include the catalytic reforming of light naphtha (54% of production), dealkylation of toluene (22%) and steam cracxing of naphtha (19%). The remaining 5% is produced as a by-product of the cooking 'process in steel mills. About half the benzene in the U.S. goes into gasoline and the other half (1.4 x 10 gallons) goes into the manufacture of ethylbenzene (for styrene) cumene (for phenol), cyclohexane (for nylon), nitrobenzene (for anilene), dodecylbenzene (for detergents), aldyl-, chloro-, and bromo- benzenes, and maleic anhydride. These uses account for about 98% of benzene in the chemical industry. DO 068501 CONFTDFNTIAL. YZ0024294 OBJECTIVES AND ACTION PLANS In November 1976, representatives from seventeen companies recommended the formation of a group that would conduct a program to: 1) assess the data beifig used by NIOSH and OSHA in proposing workplace standards for benzene; 2) develop its own recommendations; 3) gather additional data and/or conduct special studies to substantiate establishment of a standard. The first objective mentioned above was met in industry's challenge to OSHA's proposed workplace standard. The Program Panel continues to be concerned with expansion of the benzene toxicological data base and the development of industry guidelines for workplace standards. Oo ^0Mp TDFnTm, YZ0024295 CM* BENZENE PROGRAM PANEL Paul D. Halley AMOCO CHEMICALS CORP. 200 E. Randolph Dr. Chicago, Illinois 60680 B. J. Knauff ARCO CHEMICAL COMPANY 1500 Market St. P.O. Box 7258 CS-2907B Philadelphia, Pa. 19101 J. P. McCarthy Vice President and Manager Administrative Services KOPPERR COMPANY 1201 Koppers Bldg. Pittsburgh, Pa. 15219 Dr. John D. Behun MOBIL OIL CORP. 150 E. 42nd St. New York, N.Y. 10017 Stanley T. Wagner ARCO CHEMICAL COMPANY 1500 Market St. P.O. Box 7258 Philadelphia, Pa. 19101 Dr. Norman S. Salomons ASHLAND CHEMICAL COMPANY P.O. Box 2219 Columbus, Ohio 43216 Dr. A. E. Moffitt, Jr. BETHLF,,rv STEEL CORPORATION B-238 ' -.in Tower Rethlt iem, Pa. 18016 David L. McWhorter COSDRN OIL & CHEMICAL COMPANY P.O. BOX 1311 Big Sprinq, Texas 79720 Harry M. Keating MONSANTO COMPANY 800 N. Lindbergh Blvd. St. Louis, Mo. 63166 A. Merrill Schnitzer PHILLIPS PETROLEUM COMPANY Senece Bulldinq Bartlesville, Ok. 74004 Ian W. E. Harris POLYSAR LIMITED P.O. Box 52 Port Huron, Michiqan 48060 Dr. Curtis w. Smith, Chairman SHELL CHEMICAL COMPANY 1 Shell Plaza Room 1806 Houston, Texas 77001 Roger L. Daniel DOW CHEMICAL U.S.A. Building B-101 Pre port, Texas 77541 Carl W. Umland EXXON CHEMICAL COMPANY P.O. Box 3272 Houston, Texas 77001 Dr. S. N. Boyd, Jr. E. I. du PONT de NEMOURS & COMPANY Chemicals, Dyes, & Pigments Dept. B-6210 1007 Market St. Wilminqton, De. 19898 John A. Burqess GULF OIL CHEMICALS COMPANY P.O. Box 3766 Room 3070 Houston, Texas 77001 Dr. C. W. Stallard Director Corporate Health Services STANDARD OIL COMPANY (OHIO) 815 Cuyahoga Bulldinq Cleveland, Ohio 44115 Howard A. Kirsch TEXACO CHEMICAL P.O. Box 430. Bellaire, Texas 77401 Dr. H. Michael D. Utidjian UNION CARBIDE CORP. 22nd Floor 270 Park Ave. New York, N.Y. 10017 John R. We inert USS CHEMICALS DIVISION OF UNITED STATER STEEL CORP. 600 Grant St. Room 2B1 3 Pittsburgh, P . 15230 on 06RF03 CONST OF NT t YZ0024296 CMA PROTOCOL SUBGROUP OF THE TOXICOLOGY RESEARCH TASK GROUP OF THE BENZENE PROGRAM PANEL Dr. Charles E. Holdsworth* Toxicologist AMERICAN PETROLEUM INSTITUTE 2101 L Street 8t. N.w. Washington, D.C. 20037 Dr. R. A. Kuna Toxicoloqist EXXON CHEMICAL COMPANY P.O. Box 235 East Millstone, N.J. 08873 Dr. Charles o. Ward GULF SCIENCE & TECHNOLOGY 4400 Fifth Ave. P.O. Box 3240 Pittsburgh, Pa. 15230 Dr. Peter H. Craig MOBIL OIL CORPORATION Toxicology Division P.O. Box 1026 Princeton, N.J. 08540 Dr. F. Ben Thomas SHELL CHEMICAL COMPANY 1 Shell Plaza Ro m 1018 P.O. Box 4320 Houston, Texas 77210 Dr. Paul J. Garvin, Jr. STANDARD OIL COMPANY (INDIANA) 200 E. Randolph Dr. MC3B01 Chicago, Illinois 60601 Non voting) liaison with API oo 068S04 CONFTDFNTTAl YZ0024297 CMA BENZENE TOXICOLOGY RESEARCH TASK GROUP Charles E. Holdsworth, Ph.D. Toxicologist AMERICAN PETROLEUM INSTITUTE 2101 L Street, N.W. Washington, D.C. 20037 Dr. Charles O. Ward GULP SCIENCE C. TECHNOLOGY 4400 Fifth Ave. P.O. BOX 3240 Pittsburgh, Pa. 15230 Dr. Seward Ridlon ARCO CHEMICAL COMPANY 500 S. Ridqeway Ave. Glenoid n, Pa. 19036 Dr. Bernard A. Schwetz DOW comical u.s.a. Buil^mq 1803 Midland, Michiqan 48640 Dr. R. A. Kuna Toxicologist EXXON CHEMICAL COMPANY P.O. BOX 235 Bast Millstone, N.J. 08873 Dr. R. A. Scala EXXON CHEMICAL COMPANY P.O, Box 235 East Millstone, N.J. 08873 Peter E. Berteau, Ph.D. Senior Toxicology Specialist MONSANTO COMPANY 800 N. Lindberqh Blvd. - G2wn St. Louis, Mo. 63166 Dr. F. Ben Thomas SHELL CHEMICAL COMPANY 1 Shell Plaza P.O. Box 4320 Room 1018 Houston, Texas 77210 Dr. M. B. Slomka, Chairman SHELL OIL COMPANY 1 Shell Plaza Houston, Texas 77001 Dr. A. Michael Kaplan Hask 11 Laboratory E. I. du PONT de NEMOURS & COMPANY Elkton Road Newark, De. 19711 00 068505 OONFIDFNTTAL YZ0024298 CMA BENZENE PROGRAM PANEL EPIDEMIOLOGy TASK GROUP Stanley T. Wagner ARCO CHEMICAL COMPANY 1500 Market St. P.O. Box 7258 Philadelphia, Pa. 19101 David L. McWherter COSDEN OIL 6 CHEMICAL COMPANY P.O. Box 1311 Biq Bprinq, Texas 79720 Paul D. Halley STANDARD OIL COMPANY (INDIANA) 200 B. Randolph Dr. Chicago, Illinois 60601 Dr. H. M. D. Utidjian UNION CARBIDE CORP. 22nd Floor 270 Park Ave. New York, N.Y. 10017 Roqer L. Daniel DOW CHEMICAL COMPANY Building 101 Pr eport, Texas 77541 William E. Faverweather E. I. du PONT de NEMOURS & CO. Wilmington Trust 508 Wilminqton, De. 19898 Gerry Raabe MOBIL OIL CORPORATION 150 E. 42nd St. New York N.Y. 10017 Clar nee Buckley MONSANTO COMPANY WG-Krummrich Plant Sauget, Illinois 62201 Harry M. Keating MONSANTO COMPANY B00 N. Lindbergh Blvd. St. Loui8, MO. 63166 Judith A. Zaek MONSANTO COMPANY 800 N. Lindberqh Blvd. C2SH St. Louis, Mo. 63166 DO 06R506 CONF TDFNTT Al YZ0024299 AUDITING CMA recommends that all Program Panels consider third-party auditing of research projects that may be of particular interest to federal regulatory agencies, such as studies designed to test for potential mutagenicity, carcinogenicity, or reproductive effects. The Benzene Program Panel arranged for Dr, Bob West of Bob West Associates to monitor and audit the recently completed male and female reproduction studies. This and other research projects were also closely monitored by members of the Task Groups and the CMA Program Administrator. The Epidemiology Task Group made arrangements with Tabershaw Occupational Medicine Associates {TOMA) to conduct a data audit of information provided for the benzene epidemiology study. This audit will be conducted prior to analysis of the data base. DO 068507 C0NFTDFNTTA1 YZ0024300 ADVOCACY OSHA, EPA, and the Consumer Product Safety Commission have been attempting to develop regulations for benzene for several years. These efforts have been resisted by CMA ind other trade associations as being extreme and unsubstantiated by the existent scientific data base. As a result no regulation other than the formalization of the ANSI values of an 8 hour TWA of 10 ppm and a 15 minute ceiling of 25 ppm have been promulgated. OSHA In response to OSHA's efforts to develop new workplace standards, industry was successful in obtaining a stay-of-execution of an emergency temporary standard, and in voiding most features of a permanent standard by the Fifth Circuit Court in New Orleans. The Supreme Court upheld the decision of the Fifth Circuit Court when it was challenged by OSHA. The Supreme Court decision challenged OSHA's "no threshold" carcinogen policy which requires that carcino gens, such as benzene, be banned or regulated at the lowest feasible level. The Court placed the burden of proof on OSHA to establish that the present workplace standard presented a significant risk that would be reduced by the new standard. Studies underway by CMA, API, NYU, CUT, and Jefferson Medical Colleqe should provide much more information to aid in benzene risk assessment. In the future, CMA will try to work with OSHA to develop a reasonable benzene regulation dealing with exposure, monitoring, medical surveillance, and safe workplace practices. EPA Under injunction by NRDC, EPA has been attempting to develop a standard under Section Tl2 (for carcinogens) of the Clean Air Act to control emissions of benzene from stationary sources. EPA developed three reports; a study of environmental exposure, a study of health effects, and a risk assessment prepared by the Cancer Assessment Group that were reviewed by the EPA Science Advisory Board. CMA sponsored a study of environmental exposure by Foster D. Snell and industry provided comments which produced some changes in the EPA reports. On August 21, 1980, EPA held a hearing on proposed rules for emission of benzene associated with the manufac ture of maleic anhydride. CMA and API presented com ments on health effects and CMA (under EMC committee) commented on environmental emissions. Exposures to ambient benzene in areas surrounding maleic anhydride plants are 068508 00NFTDFNT TAl YZ0024301 well below 10 ppb. The risk of d v loping adverse health effects at these exposure levels is negligible and EPA may abandon this approach to regulation of benzene, in addition, benzene emissions are controlled by other regulations pertaining to volatile organic chemicals. CONSUMER PRODUCT SAFETY COMMISSION On May 19, 1978, the CPSC proposed a rule banning any products where benzene was added intentionally, and limiting the benzene concentration in products in commerce to no more than 0.1%. CMA, API, and other trade associations presented comments to the effect that the benzene content of solvents has been decreased and that the proposed level of regulation was extreme. A market survey sponsored by CPSC indicated that benzene is no longer being intentionally added to consumer products and that only 10% of the products surveyed contained over 0.1% benzene; none of the products contained more than 0,25% benzene. CPSC further states that "Since the commission has relied on much of the same underlying data as that used by OSHA on benzene, the commission needs to carefuly analyze the opinion in terms of CPSC regulations of benzene." The CPSC has extended the deadline for this issuance of a benzene ban or withdrawal of the rule until January 1981. The CMA Benzene Proqram Panel will continue to monitor this activity. RELATION TO OTHER TRADE ASSOCIATIONS In addition to CMA, other trade associations that participated in advocacy action on'benzene with OSHA include: American Petroleum Institute (API) American Iron and Steel Institute (AISI) Rubber Manufacturers Association (RMA) The CMA and API collaborated closely from the beginning with cross representation at their respective meetings. Retained outside attorneys were in close contact. Presen tations at the OSHA hearing were made independently, but Mr. Ed Warren of Kirkland and Ellis, under contract with the API, presented the case for producers and users to the Fifth Circuit Court and the Supreme Court. This collaboration worked well and contributed to the success of the venture. OUTSIDE CONSULTANTS Early in the program the group recognized the need for advice and assistance by outside consultants; therefore. Dr. I. Tabershaw and his organization and Mr. Andrew McDonald, DO 0AS509 GONF TDFNTT AL YZ0024302 Esq., of Wilmer, Cutler, and Pickering were brought into meetings early in the process. As an expert in occupational medicine. Dr. Tabershaw's knowledge of benzene and of other health experts in the field was most helpful. Mr. McDonald's advice as to possible legal maneuvers was essential. By bringing them into discussions early, they developed a firm understanding of the intracacies involved and provided important guidance as well. For the OSHA and EPA hearings, papers were presented from outstanding experts, mostly from universities. With orovth of experience in the panel, the consultant contract . Hr. Tabershaw has been cancelled. no 068510 OONFTDFNTTA! YZ0024303 i Report Title and Contract Number Survey of Benzene Emission Control Costs in the Chemical Industry (B 0.25 ECC-BAH) A Historical Prospective Mortality Study of Chemical Norkers Exposed to Benzene Determination of Time to Steady-State Level During Inhalation Exposure of Benzene by Rats a nice (B 2.0-HemIhl-B/D) Determination of the Concentration of Benzene and its Metabolites in the Blood of Rats and Mice at Various Exposure Concentrations (B 2.0-HemIhl-B/D) Determination of Material Balance of Benzen in Rats and Mice (B 2.0-HemIhl-B/D) A Dominant Lethal Inhalation Study in Rats with Benzene and A Female Fer tility Study in Rats w/Benzene (B 3.0 ff/dl-B/D) Audit of B 3.0 (B 5.0-Aud.-B/D-West) Agreement with API to Jointly Fund Benzene Inhalation Research Five-day Acute Benzene Inhalation Study 90-day Subchronic Benzene Inhalation Study Chronic Two-year Benzene Inhalation Study ^ Pulse dose Inhalation Study of Benzene o Toxicity Intermittent Exposure/Recovery Benzene y Inhalation Study X; Monitoring and Auditing of API/CMA X Jointly Funded Study (B 6.0) BENZENE Contractor Booz, Allen a Hamilton Contract Execution Date Nov. 21, 77 Tabershaw Occupational Medical Bio/dynamics, Inc. July 14, 78 April 16, 79 Bio/dynamics, Inc. April 16, 79 Bio/dynamics, Inc. Bio/dynamics, Inc. April 16, 79 Jan. 15, 80 Bob Nest Assoc., Inc. Hazleton Labs Bob Nest Assoc.r Inc. Jan. 21, 80 Nay 5, 80 May 21, 80 Nay 21, 80 Nay 21, 80 May 21, 80 Nay 21, 80 CONFTDFNTTAI K> $57,620 tot 1 for three B 2.0 Hem-Ihl-B/D Studl s U> present Level of Funding $60,000 Comments Released in 1978 167,300 In Progress 57,620* * Final report released December 17 Final report released December 17 * Final report rel ased December 17 180,000 Final report received 7,000 30,200 459,700 1,339,100 519,800 166,310 31,200 Final report receIved Administered by API Administered by API 12-22-80