Document ddVoBpKzV46eEy748rmY5Nkq

* 1CHEMSTAR " CUBICAL SHI (MIL I HCIIICAI AIIUCACr AIM! SfAICI A REPORT ON THE YEAR 1988-1989 C M A 030576 1CHEMSTAR A REPORT ON THE YEAR 1988-1989 CONTENTS Chairmans Remarks Presidents Overview 1 New and Completed Panels 3 Continuing Panels 7 Financial Resources 21 Regulatory Affairs 23 Research 25 Guidance 26 Management Services 27 PRESIDENT'S OVERVIEW 1 hemical Self-funded Technical Advocacy and Research (CHEMSTAR) - the new name for our Cspecific chemical activities - reflects a concerted effort to enhance understanding of the Chemi cal Manufacturers Association's individual chemical panels and their accomplishments. The Board of Directors recently approved a broad plan aimed at raising the visibility of the panels and thereby increasing their effectiveness in serving the industry. The name change, however, is only the most visible part of the plan. The Board also asked each CMA member company to appoint a senior corporate contact who can serve as liaison for specific chemical issues and maintain azcareness of pertinent panel activities. Vsle hope that the contacts will become advocates within their companies for assignment of the full complement of personnel and financial resources to panel participation. To amplify its action, the Board encouraged conscious attempts to broadcast panel achievements and chemical-specific advocacy opportunities widely to the industry. Already the CMA publications, CMA Mews and Chemecology, have responded with feature articles on CHEMSTAR Panels. A long-term effort is underway to encourage more panel-sponsored workshops and seminars and to ensure frequent presen tations of panel outcomes and opportunities at CMA forums. Successes at All Levels The Board's actions are, after all, based on the many significant successes of the panels in an ever-ex panding regulatory environment over the years. The year 1988-89 was no exception in providing complex regulatory and research challenges. The panels nonetheless achieved major gains while addressing the multiple state, federal and interna tional statutes affecting individual chemicals. To illustrate: At the state level, the Biocides Panel saved industry nearly S3 million dollars in testing costs by negotiating an exemption from California Senate Bill 950 data call-in requirements for selected biocides. The exemption also re sulted in better coordination of data requirements between the California Department of Food and Agriculture and EPA. At the federal level, the Methvlenedianiline Panel saved individual companies thousands of dollars in compliance costs, and avoided unnecessary workplace restrictions and medical surveillance provisions by negotiating a workplace standard on MDA with labor unions and OSHA. The nego tiation process eliminated the need for costly comment filing and testi mony. At the international level, the Lubricant Additives Panel saved companies thousands of dollars in costs of compliance with Interna tional Maritime Organization marine transport regulations by completing a testing program on several classes of additives. The data were used by IMO for assignment of pollution categories to the chemicals, which in turn dictate transport and bulk cargo handling procedures. President Chemical Manufacturers Association : I CMA 030573 1 Because Cooperation i Works ... the key to panel effectiveness is | cooperation -- among companies I and with other associations, interest i groups and government agencies, j Each ot the successes above, and the other achievements highlighted ! in this report, have this essential J characteristic. Product stewardship, long a | chemical industry emphasis, also is receiving a large boost from coop erative arrangements among companies. Increasingly, existing panels are adding regular sessions for sharing of safe handling and transportation information to their schedules. The Phosgene and Titanium Dioxide Panels are prime examples. New panels, most recently Hydrogen Fluoride and Phenol, have formed for the express purpose of providing a torum for sharing safety information. The panels hold sessions aimed at bringing the latest experiences and safety techniques to the attention of key company personnel responsible for product handling. Even in Litigation ... bv selective participation in legal challenges, CHEMSTAR panels have helped shape, correct and clarify a variety of regulations. Intervening in legal actions as a means of cooperation with other industries or government agencies has improved the regulatory environment. The Dibenzofurans/ Dibenzodioxins Panel's intervention m a lawsuit on behalf of EPA against two environmental groups was rewarded with a favorable ruling by the Federal Court. EPA's right to set its own priorities in the face of citizen petitions under TSCA was affirmed, and the Agency and industry are less subject to im promptu, unmandated regulatory influences. Even outcomes of law suits initi ated by individual panels have had cooperative effects. For example, the favorable judgment in the Phthalate Esters Panel's litigation regarding inappropriate inclusion of three phthalates on the SARA Section 302 hazardous chemicals list saved panel companies from extensive reporting and labelling requirements. As a further cooperative benefit of the ruling, 37 other chemicals were removed from the list in addition to the phthalates in question. And Internationally ... cooperation in sponsoring atmos pheric research among companies of different countries has long been the principal purpose of the Fluorocar bon Panel. By cofunding projects with NASA and other U.S. and foreign government agencies, such as the Arctic Stratospheric Airborne Expedition conducted in January, the Panel contributes to the world-wide stratospheric research effort. As a result, Panel companies continue to hold respected positions in the inter national dialogue on regulation of chloro fluorocarbons. In product health effects testing, the Chlorobenzenes and Fluoroalkenes Panels this year entered cofunding arrangements with Japanese and Belgian companies, respectively. At year's end, the U.S. manufacturers of dinitrotoluenes requested a panel to cosponsor testing with the German manufac turer, Baver AG. In all these joint testing arrangements, the financial and personnel economies of coopera tion are major benefits to the partici pating companies. With People as Key Panels are the people who run them -- making the decisions, contributing their skills and planning for the future. The achievements of the panels then, are based in yet another cooperation: between individuals who represent the member companies. In 1988-89 over 300 people participated in panel activities. The representatives established and sustained the profes sional relationships that led to panel successes. The future promises more . .. more regulations at all government levels, more panels to address the regulations and more companv representatives to participate in the panels. At the state level, the need to address Proposition 65 remains, along with a variety of other regulations in California and other states. At the federal level, EPA has announced plans for increased testing requirements under TSCA. In addition, FIFRA, SARA and Clean Air Act regulations will impact a greater number of chemi cals than ever before. And at the international level, plans for intergovernment cooperation through the Organization for Economic Community Development are leading toward extensive testing of chemicals by companies world wide. To meet these challenges existing panels will need to expand their focuses and some new panels will have to be formed. A larger group of company experts will be required to address the complicated tasks ahead. With the experience already on hand to serve as a guide, we look forward to a successful coming year. June 1989 CMA 030579 NEW AND COMPLETED PANELS ! uring 1988-89, companies requested and received CMA approval for six new CHEMSTAR DPanels. Reasons for forming the panels varied from proposed or actual testing regulations to voluntary company decisions to share information on enhancing safety in manufacturing, transportation, and use of chemicals. All six panels are now fully organized and proceeding toward their initial objectives. Three panels completed their efforts. Two of these panels made provisions for transferring future issues to other groups with related concerns. Crystalline Silica DATE CHARTERED 1989 CLRRENT TASK CROATS Administrative Analytical Methods Science Review Regulatory and Legal PANEL MANAGER Elizabeth Gormlev CHAIRMAN [oseph Shapiro L'nimin Corporation The Panel formed to address the classification of crystalline silica as a probable human carcinogen by the international Agency for Research on Cancer. This classification makes crystalline silica users subject to the OSHA Hazard Communication Standard. In addition, the National Toxicology Program recently pro posed listing the chemical on its Sixth Annual Report on Carcinogens. The Panel filed for an extension of the comment period to await information from two literature critiques that Panel companies approved for funding. The Panel's first priority is to determine the adequacy of scientific . research on the health effects of crys talline silica. Panel members plan to monitor and respond to technical, regulatory, and legal issues as they appear. CMA 030580 3 Diisocyanates .'ATliJIARTlREE' 1988 ^LRRtsr TA^CROU", Industrial Hvgieni: Health Effects `A N t L M AN ACER ! Robert Romano j | chairman lames Chapman Moba\ Corporation Dinitrotoluenes n\rr auRitRtn 1989 *LRRL\r Toxicology I'VV-L M \\ \C,f R Barbara Francis CHAIRMAN Thomas Marriott Air Products and Chemicals, Inc, Hexamethylene Diisocyanate DATE CHARTERED 1988 CLRRENT TASKCROLP Toxicology PANEL MAX ACER Carol Stack CHAIRMAN Donald Lamb Mobay Corporation The Panel formed in response to an EPA proposal to regulate the isocy anate process as a hazardous air pollutant under the Clean Air Act j Section 112. In addition, the Agency announced preparation of Health Assessment Documents on toluene diisocyanate and methyl isocyanate. The State of California also announced its review of toluene diisocvanate with intent to list as a carcinogen under Proposition 65. The overall goal of the Panel is to develop and disseminate information on the safe handling of diisocyanates, including: toluene diisocvanate: methylenebisdiphenvl diisocvanate; hexamethvlene diisocvanate; and, methvlenebisdicyclohexvl diisocvanate. The Panel also will monitor impending regulations affecting the production or use ot diisocvanates and develop neces sary responses. The Panel is working with EPA to ensure that the Agency has all data necessary to make informed decisions during consideration of Clean Air Act regulations. The Panel formed to work with Bayer AG on a voluntary testing pro gram. Representatives of the U.S. EPA and F R.G. government agencies identi fied DNT as a possible subject for coop erative testing between companies in the two countries. The agencies' stated objectives were to promote sharing of the cost of research and to ensure the availa bility of adequate hazard data in both the U.S. and the F.R.G. The Panel and Bayer agreed to undertake a pilot pharmacoki netics prefect m response to the agencies' request. The pharmacokinetics study will begin in late 1989, Final reports will be submitted to agencies m both countries. The Panel intends to continue interacting with the agencies in an effort to assess the need for additional testing. The Panel formed to address the inclusion of HDI in the Interagency Testing Committee's priority list of chemicals for testing under TSCA Section 4. ITC designated the chemical for response bv EPA within 12 months, EPA's proposed test rule for HDI requires oncogenicity, mutagenicity, reproductive toxicity, developmental toxicity, and neurotoxicity studies. In addition, the proposal includes com parative pharmacokinetics and hydrolysis testing. The Panel provided information to the Agency following a public focus meeting in June. Afterward, the Panel submitted comments in response to the proposed test rule. 4 DMA 030581. Hydrogen Fluoride DATE CHARTERED 1988 C. RREsr ea-cgA'i:'- storage and Svstems Personal Protective Equipment Medical Treatment Responsible Care-Risk Communications Materials ot Construction CHAIRMAN S C Watkins \Ihed-5ignal Inc Mutual Aid-Emergency Response Transportation r\v i manager Elizabeth Gormlev j The Panel formed to provide a j forum for U.S. and Mexican producers ! and shippers to share information on i safety in the manufacture and transpor tation ot, and emergency response pro cedures for, hydrogen fluoride. The Panel will monitor regulatory activities bv government agencies and respond when necessary. In September, the Panel spon sored a Safety Seminar to alert com pany personnel to new safety technol ogy and techniques. The Seminar will | be an annual event. The Panel also has j established liaison with the Comite ! Technique Europeen du Fluor of the i Conseil Europeen des Federations de ' ITndustrie Chimique in order to share i safetv information with European i manufacturers. Phenol r>XTE L H XRTf-'RtP 1988 CLRKrAI (",ROL !' Regulatory AML M \N \GER Susan Howe CMA1RM \N Edwin Fraini Dow Chemical ISA The Panel formed to promote greater safety in the production, trans portation and use of phenol. Member companies exchange non-proprietary satetv information on topics such as transportation training, tank car han dling, exposure treatment, sampling svstems, emergency response proce dures, and waste disposal. Health and environmental concerns about phenol are addressed by the Regulatory Task Group, The Panel plans to sponsor research programs, symposia, and workshops on sate handling. In the near future, the Panel also will develop criteria and present awards recognizing worker safety excellence at phenolproducing plants. Arsenic (Completed Panel) date chartered 1981 clRRENT T.ASX UROL PS None PANEL MANAGER Has Shah CHAIRMAN Donald McGraw i Kuppers Company i The Panel received a draft final report from Consultants in Epidemiol ogy and Occupational Health on the analysis of epidemiologic data on Anaconda smelter workers. The purpose of this Panel-sponsored analysis was to assess whether the risk of respiratory cancer death was dependent upon a worker's highest arsenic exposure assignment category The analysis of the data, while raising questions about the original study, appears to support a threshold model for carcinogenicity. After review, the Panel accepted the draft report. The Panel formed to address the impact of OSHA and EPA regulations on manufacturers and users of arsenic, and to sponsor appropriate research. The Panel completed its advocacy and research goals and decided to sunset in May. j ; 1 1 I CMA 030582 Epoxy Resins (Completed Panel) Octylphenol (Completed Panel) PATE CHARTERED 1^81 CLRRtMTA^kCROLr Toxicology Research L'VTE CHARTERED W83 CURRENT TASK CROC ['S \one maw.lk Has Shah chairman Harold Flegenheimer Interchem, Inc f'WEL \U\ \C,ER Henrv Sauer CHAIRMAN Ronald Keener Rohm and Haas Company \o new activities were under taken by the Panel this year. Previous Panel activities included the collection and evaluation of production, use, exposure, environmental release, and health effects information on epoxy diluents represented in the category, "glvcidol and its derivatives." In 1984, the Panel submitted this information to EPA in response to the Agency's Ad vance Notice of Proposed Rulemaking seeking guidance on the selection of representative chemicals for testing of this chemical category. In 1978, the Interagency Testing Committee designated the category for priority consideration by the Agency under TSCA Section 4. The ITC recom mended testing for carcinogenicity, mutagenicity, teratogenicity, other toxic effects, and epidemiology. The Panel decided to disband in March and merged its activities with the Epoxy Resins System Task Force of the Society of Plastics Industry. The Panel decided to terminate following EPA's acceptance of a series ot aquatic studies sponsored by the Panel under a voluntary negotiated agreement with the Agency. The Panel formed in 1983 in response to EPA's request for testing under TSCA Section 4. In 1982, the Interagency Testing Committee desig nated octylphenol for priority testing under TSCA Section 4 and recommended studies on health and environmental effects and chemical fate. Further interests of octylphenol producers will be pursued by the Alkylphenols and Ethoxvlates Panel, which formed recently to respond to EPA concerns under tSCA about nonylphenol and related chemicals. In addition, the EPA Office of Water Regulations and Standards expressed interest in regulating alkylphenols, including octylphenol. Panel companies joined producers of nonvlphenol and alkylphenol ethoxylates in the new panel in order to provide a coordinated industry response to this Agency effort. 6 CMA 03058 CONTINUING PANELS orty-seven CHEMSTAR Panels are now officially approved by CMA, Each sanctioned panel Foperates under a charter which defines its scope within the framework of the Association's ge neric interests. Panel membership rosters during 1988-89 included 223 companies and 13 asso ciations. Among the company members, 104 were members ofCMA and 19 were non-U.S. and nonCanadian. Participating companies and associations were represented on panels and task groups by ap proximately 340 persons with professional skills ranging from physical and biological sciences, through engineering and industrial hygiene, to legal and business areas. Besides the association members, the panels maintained liaison with a total of 45 other associations. L. Alkanolamines PATE (Jl.ARTFRED 1982 (_LRREXTTA;XCROir Toxicology Research I'WtL MAS ACER Henrv Sauer C HA1RMA.N Edward Bentley Texaco Chemical Company Alkylphenols and Ethoxylates D\TE CHARTERED 1987 CLRREM TASK GROL PS Environmental Survey Modeling Study Toxicology PANEL MA.SACER Henrv Sauer OLVIRM AS lav Amell GAP Corporation \'o new activities were undertaken by the Panel this year. EPA, under TSCA Section 8(d), required manufacturers and importers of triethanolamine and dietha nolamine to provide information on pro duction, use, and exposure and to submit lists and copies of unpublished health and safety studies. Also, the National Toxicology Program initiated two-year chronic studies of triethanolamine using skin painting with rats and male mice. The Panel formed to determine the toxicological properties and environ mental effects of alkanolamines in response to concern raised by a Japanese study implicating triethanolamine as a possible carcinogen. The Panel sponsored toxicology studies on the chemical and tentatively planned research on other alkanolamines. The Panel will monitor the NTP research programs as guidance for its own future testing. The Panel provided EPA with the results of two voluntary studies on environmental monitoring and model ing. The studies were sponsored to investigate the presence of nonvlphenol ethoxylate species in the discharge of municipal sewage treatment plants, receiving waters, and sediments at two selected river sites. The Exposure Analyses Modeling System was applied to these data to investigate differing environmental conditions and waste treatment plant types. In cooperation with EPA, the Panel also developed a protocol for a national environmental monitoring survey. The Panel then initiated the survey, and notified the Agency of its inten tions to negotiate a consent order under TSCA Section 4 for testing nonylphenol. The Panel formed to determine the health and environmental effects of alkylphenols and ethoxylates in manufacture and use. Initial efforts focused on responding to EPA concerns regarding the chemical fate and environmental effects of non ylphenol. The Panel maintains liaison with the Soap and Detergent Associa tion on scientific and regulatory issues. Membership is open to manufacturers, users, and formula- tors. CMA 030584 / Results from the voluntary national environmental monitoring program will be available in early 1990. The Panel also plans to execute a consent order and complete chemical fate and environmental effects testing with nonylphenol bv early 1990. ; Aromatic Diamines . a t ch \:<rr rep 1987 ..LRRENT TAunCROLI' | Toxicologv Research "'N[ 1 MANAGER Carol Stack CHAIRMAN Robert Smith Ethvl Corporation The Panel investigated potential areas ot research to clarify differences in the biological activity of substituted aromatic diamines. Panel toxicologists and CUT scientists conferred on the development of a testing program. The Panel formed to develop a strategy acceptable to EPA for achiev ing PMN approvals without a long term bioassav on each new product. Currently, very limited structureactivity data exist to refute the Agency's assumption that all substituted aro matic diamines are potentially carcino genic. The Panel is planning research to explore how substitution on the j aromatic diamine ring affects carcino genic potential. Benzene HUE i_H \R TERED 1976 VLRRENT rwkl.ROll1 Toxiculogv Research \\ti M IN UXR Carol Stack tv CHAIRMAN Roger Daniel Dow Chemical USA Panel member companies worked closely vv ith the CMA Hazardous Air Pollutants Work Group in developing comments on an EPA proposal for limiting benzene emissions from four stationary source categories. These cate gories include: ethylbenzene/stvrene plants; storage vessels; coke oven by product facilities; and fugitive emissions. The proposals reflect the Agency's new approach to standard-setting under the Clean Air Act. EPA described four alternative approaches to determining a safe and acceptable level of risk in the proposal. The chosen approach may have a large impact on future standard- setting. Final rules are expected to be published by fall 1989. The Panel also submitted benzene emissions data to EPA for use in redefin ing model plant emissions estimates and evaluating the present level of risk. The Agency requested information on process and storage tank emissions, controls, and fugitive emissions. Subse quently, the Panel responded to an Agency request for information on addi tional benzene source categories to assist the determination of whether Clean Air Act Section 112 regulation is necessary. The Agency is under a court order to make a decision in August 1989. Since its formation, the Panel has pursued an active research and advocacy program. Responding to a NIOSH occu pational study linking benzene exposure to leukemia, the Panel sponsored an industry epidemiology study in 1983. Also, in cooperation with the American Petroleum Institute, the Panel established a research program examining subchronic toxicity, metabolism and reproductive effects. Although Panel attention will remain focused on Clean Air Act regulations, further mechanistic research on benzene-induced leukemogenesis is contemplated in conjunction with API. Biocides DAI t CHARTERED 1986 CURRENT TCRCCTS Legislative Scientific Assessment Regulatorv Exposure Specific Chemicals ''VNEL MAN VGER Has Shah CHAIRMAN Jane Yuster Trov Chemical Corporation In the fall, the Panel identified concerns with the proposed FIFRA Amendments being considered by Congress. The Panel worked with the CMA Government Relations Commit tee in supporting industry-accepted proposals for modifying the reauthori zation Amendments. When Congress passed the legislation, these modifica tions were incorporated. EPA solicited Panel comments on its draft Instruction Booklet, containing general information on applying for registration of pesticides in the U.S. The Panel reviewed the draft and sub mitted comments to the Agency on the Booklet's guidance to those seeking pesticide registrations, expenmental use permits, and tolerances. EPA has promised to incorporate these com ments. The Panel filed comments with the Office of Management and Budget on the EPA requests for approval of the draft Reregistration Phase 2 Guidance document. In its comments, the Panel asked OMB to disapprove the Agency's request. The Panel felt that the Agency dramatically underestimated the eco nomic impact of the reregistration re quirements, and was attempting to revise substantive regulations without following appropriate notice and comment procedures. OMB agreed with the Panel's view and asked the Agency to revise the Document. The revised Document eliminated most industry concerns. The Exposure Assessment Task Force began developing antimicrobial exposure data for various end-use patterns as required by a FIFRA antimi crobial data call-in issued by EPA. The study is expected to be completed in the fall. The Task Force also obtained an interim waiver from the Agency in con ducting post-application exposure assessments for metal working fluids, based on technical difficulties in con ducting the assessments. The Panel filed comments with OSHA on the Hazard Communication Standard for Formaldehyde, supporting 8 CMA 030585 a proposed administrative stav of the provisions. The Agencv granted a ninemonth stay ot the standard based on all i comments received. During this period, OSHA will propose to revoke certain paragraphs ot the standard and invite comments on a proposal to apply the general Hazard Communication Standard to formaldehyde. The Arsenic Acid Task Force completed glove and protective ' clothing permeability studies on arsenic acid and inorganic arsenical wood preservatives. The results showed no measurable permeation of arsenic or chromium through the tested materials. In August, EPA issued Guidance tor the Reregistration of Wood Preservative Products Containing Arsenic, Chro mium, and Chromated Arsenical Com pounds as the Active Ingredients. The Task Force responded by identifying ; serious concerns, including overlapping data call-ins, inappropriate test material 5 designations, and unsuitable labeling requirements. The Agency has not yet ! responded to the Task Force's requests i tor modification of the standard, | The Panel formed m 1986 in response to the California Department ! of Food and Agriculture Data Call-In I .Notices on biocidal chemicals regis tered in the state. The DCI required ; that registrants submit data on chronic toxicity, oncogenicity, reproductive effects, teratogenicity, mutagenicity, and j neurotoxicity. The Panel's goal is to address issues associated with this regulation and anv other regulatory actions affecting biocides, i The Panel will continue monitor ing FIFRA legislative activities, and will work with the California DFA to clarify data call-ins issued under the Birth Defect Prevention Act, and monitor California Proposition 63 activities. Panel task forces will monitor federal 1 and state activities that may specifically impact their focuses. i Butadiene PATF CHARTERED i_ lRRENT TVER l Roll"- Toxicology Research Industrial Hygiene Environmental ASH MANAGER-. Robert Toro and Robert Romano CHAIRMAN lames Bonin Shell Chemical Companv The Panel sponsored a fugitive emissions study in response to the EPA announcement of an intent to list 1,3butadiene as a hazardous air pollutant under the Clean Air Act. The objective of the study was to measure and quantify emissions tor SARA Section 313 report ing and risk assessment. The study has become a model in the field of quantify ing fugitive emissions. Results showed that actual emissions are at least 80% less than earlier Agency estimates. The Panel also maintained liaison with OSHA on the butadiene workplace standard under review. In a subsidiary activity, the Panel submitted petitions for delisting ethylene and propylene under SARA Section 313. The Panel formed in the aftermath of an EPA consideration of butadiene under T5CA Section 4(0. The Panel aimed to collect and evaluate informa tion needed to assess safety, environ mental, and health issues arising from production, storage, transportation, use, and disposal of butadiene. The Panel provided comments to the Agency on two risk assessments and worked with the Agency in assessing "short-term" releases of butadiene. EPA then referred butadiene to OSHA under TSCA Section 9(a). The Panel will present the final results of the fugitive emissions report to EPA and will follow the development of the OSHA workplace standard. In addition, the Panel plans to develop research strategies and monitor ongoing research pertaining to butadiene, including both animal and epidemiology studies. Butylated Hyaroxytoluene date chartered 1977 CURRENT TASK GROUPS None "ANIL MANAGER Susan Howe CHAIRMAN John Zora \eville-5vmhese Organics The Panel followed up on its Citizen Petition tiled in 1986 which requested that the FDA issue a regula tion recognizing a prior sanction for use of butylated hydroxytoluene. To sup plement the Petition, the Panel pro vided information to FDA on a compre hensive research program undertaken by the European BHT Manufacturers Association. The data from this research program will aid in evaluating the potential for human carcinogenicity. The FDA has not yet announced a date for its decision on the Petition The Panel organized to conduct research and advocacy necessary to support the continued use of BHT in food additive applications. In 1978, the Panel filed comments in response to an FDA proposal for interim regulations requiring testing to resolve safety ques tions. To date, FDA has not issued an interim regulation. The Panel will cooperate with the FDA in its current evaluation of BHT and may develop additional scientific information, if appropriate. The Panel also will continue its advocacy on BHT through its liaisons with the European BHT Manufacturers Association and the U.S. FDA. CHA 030586 9 Chlorine Dioxide DATE CHARTER 1988 CLRRENTTAAxGROLi'A Communication Technical Regulatory chairman Toxicology vv.lliam Scott P-WEL MW \(,ER Robert Romano Albright & Wilson Americas Chlorobenzenes RATE lELXRTERED 1974 1.LRRENT rvsKL.ROLP Toxicology Research ['WEI MANAGER Carol Stack CHAIRMAN James Brvant Standard Chlorine Chemical Co,. Inc. Cresols date CHARTERED 1984 clrrent taskgrolp Toxicology Research PANEL MANAGER Barbara Francis chairman lohnnv Walbrick Merichem Cumpanv The Panel completed a literature survey on the toxicological effects of chlorine dioxide and sodium chlorite. To comply with a 1988 FIFRA data callin on chlorine dioxide and sodium chlorite, the Panel sponsored full, raw data reviews on an 85-week bioassav in mice conducted in Japan, and on a rat teratology study conducted at Ohio State University. The Panel formed in anticipation of an EPA proposal to regulate chlorine dioxide under the Safe Drinking Water Act by 1991. In addition, the State of California contracted for a risk assess ment on chlorine dioxide and sodium chlorite. The Panel aims to gather, review, generate, and disseminate in formation on chlorine dioxide and its precursors, sodium chlorite and sodium chlorate. The Panel monitors and interacts with regulatory agencies and fosters scientific communications. Primary focuses of the Panel are gen eration, applications, health effects, safety, and test methods. Future Panel activities include sponsoring a teratology study in rabbits for submission to EPA. Panel represen tatives will continue to interact with FIFRA and Office of Drinking Water staff on research issues. The Panel will cosponsor with EPA an international symposium on chlorine dioxide in Denver, Colorado in November 1989. The Panel sponsored research to meet testing requirements under TSCA Section 4 and a FIFRA Data Call-In. The Panel completed the following studies: reproduction and fertility studies on 1,2and 1,4-dichlorobenzene and 1,2,4,5tetrachlorobenzene; 90-day subchronic feeding studies on 1,2,4-trichlorobenzene in rats and mice; acute toxicity studies on 1,2,3- and 1,2,4-trichlorobenzene in marine and freshwater organisms; and, hvdrolvsis studies on 1,2-dichlorobenzene and 1,2,4,5-tetrachlorobenzene. The Panel submitted the final reports to EPA. In 1987, the EPA Office of Pesti cides Programs issued a data call-in on 1.4- dichlorobenzene. Some required studies are in progress and others are in the planning stage. Studies in progress include: acute toxicity to a freshwater invertebrate and fowl; a 21-day dermal study in rats; and, a comparative phar macokinetics study. The Panel formed to sponsor voluntary research on chlorobenzenes. The focus on research remains, but now the emphasis is on completing mandated research on health and environmental effects. The Panel continues to provide technical support for the advocacy activities of the Chlorobenzenes Produc ers Association, an affiliate of the Synthetic Organic Chemical Manufactur ers Association. The Panel's TSCA testing program will continue with the chronic studies of 1.2.4- trichlorobenzene The other primary activity will be the studies of 1.4- dichlorobenzene required under FIFRA. The Panel will consider conduct ing an epidemiology study of workers exposed to this chemical. The Panel has nearly completed testing of three cresol isomers in com pliance with a TSCA Section 4 test rule. Draft reports on mutagenicity testing and reproductive effects are currently being reviewed for submission to EPA later this year. Since its formation, the Panel has worked with the Agency's Test Rules Development Branch, Office of Solid Waste, and the National Toxicology Program to ensure that logical and sci entifically sound testing programs are conducted on cresols. After submission of all reports required under the test rule, the Panel will maintain liaison with EPA to track and assist analyses of the data by Agency scientists. Cumene DATE CHARTERED 1985 CLRRENT TASK CROC PS, Toxicology Research Mutagenicity PANEL MANACER Barbara Francis Georgia Gulf Corporation In compliance with a TSCA Section 4 Test Rule issued in July 1988, the Panel initiated testing of health effects, environmental effects, and chemical fate. Because Tier I mutagen icity tests voluntarily submitted to EPA by the Panel were negative, no highertier mutagenicity or oncogenicity testing is required under the Rule. The Panel expects most of the required testing to be completed in 1990. Through a judicial challenge, the Panel is seeking definition of "substan tial" exposure limits by which the Agency can require testing under TSCA Section 4(a)(1)(B). The case was argued in the New Orleans, Louisiana Court of Appeals in June 1989, and a decision is expected in the near future. The issue 10 CMA 030587 ! presented has possible ramifications for all chemicals in which testing might be required solely on the basis of "substan tial human or environmental expo sure," The Panel formed as a result of i the Interagency Testing Committee's , designation of cumene for priority ; testing. The Panel's objective is to collect information that will allow tor the assessment of health and environ mental effects arising out of the produc tion, storage, use, and disposal of cumene The Panel will continue to sponsor testing and interact with EPA scientists in the assessment of possible further testing needs. Cyclohexane date chartered 1985 CLRRENT Tank CROC PS Toxicology Research User Exposure Survey PANEL MANAGER Henrv Sauer chairman Russell Cook Phillips Chemical Company EPA denied the Panel's petition to delist cyclohexane from toxic chemical release reporting under SARA Section 313. The Agency denied the petition due to the contribution of cyclohexane releases to total industrial air emissions from volatile organic I compounds. The Panel also obtained proposals from qualified laboratories to j conduct health effects testing. Manufacturers formed the Panel to address the Interagency Testing Committee's intent to designate cvclohexane for priority testing under TSCA Section 4 EPA formally desig nated the chemical for health effects testing in 1986. 1 The Panel will work with the ; Butadiene Panel to develop specific i language for recommended legislative ; action on SARA Section 313. The language will aid in clarifying the VOC ! issue and will eliminate the need for ! unnecessary reporting. The Panel also is preparing for the TSCA Section 4 test rule expected from EPA in December. Dibenzofurans/ Dibenzodioxins PUECIURTF^EP LQ84 CL RRENT TAbk v. i<t. 'I Ps None panel manager Elizabeth Gormlev chairman Kenneth Burgess The Dow Chemical Company The Environmental Defense Fund and the National Wildlife Federation appealed the 1988 summary judgement of their lawsuit against EPA. In the suit, EDF and WVF had sought to force the Agency to initiate a TSCA Section 6 rulemaking on dioxins. The Federal Court ruled in tavor of the Agency's right to "set its own priorities" in the face of citizens' petitions. The Panel is monitor ing the appeal because it intervened in support of the Agency in the lawsuit. The Panel formed when EDF and NWF filed the TSCA Section 21 Petition. In addressing the EPA response, the Panel commented to the Agency on proposed rules under TSCA Sections 4 and 8. Final rulemakings on the two sec tions require analyses of chemicals for the presence of dibenzofurans and diben zodioxins as impurities and reporting of production, processing, use, exposure, and disposal data. Future activities for the Panel include monitoring the recommendations of the EPA Science Advisory Board on the Agencv's risk specific dose docu ment. The Panel also will continue monitoring the Court of Appeals challenge in the EDF/NWF v EPA suit. Future activities are dependent upon the Court's decision. Ethylene Dibromide DATE CHARTERED 1982 CIRRENT TASK CROATS None PANEL MANAGER Robert Romano chairman Vernon White Great Lakes Chemical Corporation The Panel formed to address the OSHA Standard with the goal ot ensuring that reasonable regulations are adopted. Once the rule is issued, the Panel will review the requirements and evaluate the effects on industry. ; i Ethvlene Dichloride rUTE CHARTERED 1974 CLRREM T \'k CROLP'? \one PWEl MAN kCER Henry Sauer Dovs Chemical Compam The Panel continued monitoring the EPA review of ethylene dichloride under the Clean Air Act "intent-to-hst" category as a hazardous air pollutant. The Panel also submitted recommenda tions to ATSDR for improving the draft Toxicological Profile for the chemical under SARA Section 110. In addition, the Panel submitted recommendations to OSHA on the final standard for per missible exposure limits for workplace exposure. The Panel formed to address Federal and State agencies m all safety and health issues arising out of the production, distribution, and use ot EDC. Initially, the Panel focused on evaluating scientific literature, identitving data gaps, and undertaking addi tional toxicological studies to improve the research data base. The Panel voluntarily sponsored studies of chronic inhalation, metabolism, and teratogenicity. EPA's "intent to list" decision is due shortly. The Panel will review the proposal and provide comments. The Panel will continue to work with the EPA Office of Air Quality Planning and Standards to ensure that the proposal to regulate EDC emissions under the CAA is based on sound scientific data. The Panel also will track Safe Drinking Water Act regulations and the SARA Toxicological Profile in the coming year. OSHA has not vet issued a final rule revising the Federal Occupational Standard tor ethylene dibromide. The Panel therefore had no need to meet this year. CMA 030588 11 Ethylene Glycol DATE CHARTERED 1986 CURRENT TASK GROUP Toxicology Research "AXELMANACER Carol Stack CHAIRMAN Dennis Macaulev Union Carbide Corporation As part of the third year of a voluntary research program, the Panel completed an oral (gavage) develop mental toxicity study in mice and established a no-observed-effect level in this species . The Panel also completed a material balance and pharmacokinet ics study in rats following single intravenous, peroral or percutaneous administration of ethvlene glycol. In addition, the Panel conducted a systematic review of the health effects data base on diethylene glycol, which summarized findings from acute, mut agenicity, reproduction, developmental toxicity, subchronic, and chronic studies. The Panel provided these findings to the NTP Division of Toxicology Research and Testing, for consideration in assessing research needs. NTP and the Panel independ ently decided not to pursue a testing program on the chemical at this time. The Panel formed to augment the toxicological data base on ethylene glycol. In particular, the Panel focused on investigating the potential for developmental toxicity and pharma cokinetics research in mice and rats. Research in these two areas will continue. A pharmacokinetics study in female mice is underway and an oral (gavage) developmental toxicity study m rats is scheduled to begin in July. Ethylene Oxide DATE CHARTERED 1981 CURRENT TASK CROC I'1 Scientific Industrial Hygiene Environmental Toxicology Economic Risk Assessment CHAIRMAN Ronald Van Mvnen Union Carbide Corporation .'ANEL MANAGER Robert Romano 2-Ethylhexanoic Acid nATE CHARTERED 1984 CURRENT TASK CROUP Toxicology Research RANEL MANAGER Henry Sauer chairman Roderick Gervve Tennessee Eastman Company The Ethvlene Oxide Industry The Panel obtained a judicial Council completed a fugitive emissions review of the final test rule for 2- study with EPA. The study has become ethylhexanoic acid under TSCA Section a model in the field of quantifying 4. Although the Court upheld EPA's fugitive emissions. The objective of the position, the review clarified the study was to measure and quantify Agency's broad discretion to require fugitive emissions at production facilities testing on the basis of little information for use in SARA Section 313 reporting on either health effects or significant and risk assessments. Results show that human exposure. The testing program actual emissions are at least 90% less required under TSCA Section 4 was than the Agency's previous estimates. completed by the Panel. Several scientific papers on the results of The Panel formed following the this study were presented at international ; Interagency Testing Committee's conferences. The results also were designation of 2-ethylhexanoic acid for shared with interested CMA Environ priority testing under TSCA Section 4. mental Management Committee task The Panel submitted data to the Agency groups for use in developing industry documenting the uses and manufactur wide policies on emissions. ing processes associated with the The Panel formed to evaluate the t chemical. Since EHA is used solely as a results of an animal study that may affect chemical intermediate and is manufac OSHA and EPA regulatory proceedings, i tured and processed in a closed system, The EOIC addresses many regulatory the Panel has focused on demonstrating and scientific activities in an effort to that there is no significant human expo provide both agencies with enough infor sure. mation to make reasonable and scientifi The Panel will contribute to the cally sound decisions on regulatory Agency's review of health assessment controls. guidelines for suspect developmental The Panel is evaluating the toxicants. The Panel also is planning a feasibility of conducting a pharmacoki risk assessment. netics physiological modeling study. , This summer, the Toxicology Task Group will attempt to identify laborato 2-Ethylhexanol ries that can perform the study. A decision by EPA on a Clean Air DATE CHARTERED Act Section 112 hazardous air pollutant i 1986 listing is expected in December 1989. The EOIC will review and comment on the outcome. In addition, because j CURRENT TASK CROUPS j Toxicology Research j Butvraldehyde ethylene oxide is included in the priority i list of chemicals to be regulated, EOIC ; PANEL MANAGER' Has Shah will track closely and comment on the implementation of California Proposition i chairman Richard Wise Union Carbide Corporation 65. ! The Panel initiated a two-year i oncogenicity study in mice and rats required under a TSCA Section 4 test rule. On a voluntary basis, the Panel also completed a developmental toxicity evaluation of 2-EH in rats. There was no evidence of developmen tal toxicity at any dose level tested. In addition, the Panel voluntarily initiated 12 CMA 030589 pharmacokinetics studv on 2-EH, but terminated it due to problems encoun tered in determining the purity ot radio-labelled 2-EH. In order to assist EPA in assessing exposure to butvraldehvde, the Panel formed a Butyraldehyde Task Force. The Interagency Testing Committee rec ommended health and ecological effects testing on butvraldehvde if there is significant worker and general popula tion exposure to the chemical. The Panel tormed to address a TSCA Section 4 test rule issued by EPA 1 at the request of the National Toxicol ogy Program. \TP requested this testing when budget cuts torced the cancellation of its two-year rat and mouse bioassav on 2-EH The final rule \ was published in August. ; The Panel will continue to monitor the progress of the oncogen icity studv and will decide if a pharma cokinetics study should be repeated. Fluoroalkenes tort CHARTER 1987 cLRREXT Txsn lSOU'S Specific Chemicals Producers \ Specific Chemicals Toxicology j l'AN[ 1. MAX ACER Barbara Francis CHAIRMAN Roland Stahl I E I du Pont de Nemours & Co. ! The Panel is conducting tests required under TSCA Section 4. EPA , required testing of four fluoroalkene monomers in the areas of mutagenicity, subchromc toxicity, and oncogenicity. The monomers are vinvl fluoride, vinvlidene fluoride, hexafluoro- i propene, and tetrafluoroethene. The Panel submitted final reports for all completed studies to EPA for review. Oncogenicity testing of vinvlidene fluoride and vinvl fluoride is underwav. In July, the Panel presented comments at a Fluoroalkenes Public Program review concerning triggered mutagenicity and oncogenicity testing under the tinal test rule. The Panel is awaiting the Agency's decision on whether an oncogenicity study will be ! required for HFP, and mouse-specific ! locus assay for vinyl fluoride. ' The manufacturers originally formed a coalition to address the ITC's I 1480 designation of fluoroalkenes for i priority testing consideration under j TSCA Section 4. The coalition reorgan ized as a panel under the auspices of CMA after the test rule was final. The Panel will continue to sponsor required tests and will interact with EPA in the evaluation of testing requirements. Fluorocarbons LnrECiur<rtKtD 1972 CLRREM TA-\ C.ROi;"'. Atmospheric Sciences External Affairs Effects a f\\tL MAX ACER Elizabeth Gormlev LH.AiRM.AN 5 Robert Orfeo Allied-Signal Corporation The Panel completed a written review of the science of chlorofluorocarbons in the atmosphere, which included the results of the Arctic and Antarctic missions and the Ozone Trends Panel report. Based on current scientific infor mation, the Panel concluded that a complete phase-out of chlorofluorocarbons is warranted However, the extent of CFC reduction and broad global participation in the phase-out are more important than timing. The Panel funded the preparation of a monograph on biological health effects, which was submitted to UNEP, and co-funded the Airborne Arctic Stratospheric Experiment. The Panel has been focusing attention on how to im prove the current network measuring UVB radiation reaching the earth's sur face. Other Panel activities included hosting a workshop and funding research on the factors which control UVB penetration to ground level, including the role of cloud cover and the design of new instrumentation. The Panel formed to fund research to determine the environmental fate of CFCs. To date, the Panel has supported more than S24 million of research. Sponsored studies have addressed at mospheric chemistry, atmospheric meas urements, modelling, and trend analysis. The Panel's focus has broadened in recent years to include monitoring developments ot research in the climate/ greenhouse and biological effects areas. The Panel also has played an important role in funding the development of more sophisticated equipment, such as the microwave instrument used to detect chlorine monoxide In the coming year the Panel will focus its efforts on completing its work in progress as industry turns its attention to developing alternatives to CFCs. Glycol Ethers DATE CHARTERED 1980 CLRRENTTASA CROLP Toxicology Research PANEL MANAGERS Carol Stack and Robert Toro CHAIRMAN Richard Wise Lmon Carbide Corporation The ethylene glycol ethers that continued to dominate the Panel's research activities were ethylene glycol monobutyl ether, diethvlene glycol butyl ether and its acetate, and trieth ylene glycol monomethyl ether. Studies to investigate the hemolytic mechanism(s) of EGBE in rats are in progress, and similar in vitro studies are planned to evaluate human effects. The Panel also contracted with a public relations firm to produce a brochure on EGBE which dispels some of the misun derstandings concerning the chemical and human health. In response to a TSCA Section 4 test rule on DGBE/DGBA, the Panel initiated a 90-day subchronic and fertility study on DG8E, a neurotoxicity study on DGBE, and dermal pharma cokinetics studies on DGBE and DGBA. The subchronic and neurotoxicity studies have been completed. Technical problems forced delays with the phar macokinetics studies; however, the studies will be underway again shortly. The Panel negotiated a consent order in lieu of a TSCA Section 4 test rule to perform health effects testing on triethylene glycol monoethvl ether. The purpose of this three-year testing program is to characterize the genotoxicity, developmental toxicity, subchronic toxicity, and subchronic neuro toxicity of the chemical. In another TSCA Section 4 activity, EPA issued a final test rule requiring developmental neurotoxicity testing on TGME. The Panel will initiate the test after EPA publishes its receipt of TGME develop mental toxicity data. The Panel's regulatory activities include tracking an OSHA rulemaking on 2-methoxvethanol, 2-ethoxvethanol and their acetates. An OSHA Notice of Proposed Rulemaking is anticipated. The Panel also commented on the listing of these glycol ethers as repro ductive toxicants under California Proposition 65 regulations. The Panel formed to develop an adequate toxicity data base, provide information to users and government CMA 030590 13 agencies on the safety of the chemicals, and promote scientifically sound regulatory action. The Panel addresses these issues and continues to build on its accomplishments. The Panel will continue respond ing to EPA-mandated test rules under TSCA Section 4 and is supporting testing required under the TGME consent order. Producers of the glycol ethers of concern to OSHA will respond to the NPR when it issues. The Panel also will continue monitoring air and water regulations in California. Hydroquinone date chartered 1984 CURRENT TASK CROCR Toxicology Research panel manager, Henry Sauer CHAIRMAN Robert Brothers Eastman Kodak Company The Panel completed pharma cokinetics, neurotoxicity and develop mental toxicity studies as part of requirements under a TSCA Section 4 test rule. The Panel also participated in peer review of the National Toxicology Program carcinogenesis studies with rats and mice. The Panel formed in response to a proposed TSCA Section 4 test rule published by EPA in 1984. Subse quently, the Panel submitted extensive comments to the Agency and presented data at the rulemaking hearing. In addition, the Panel voluntarily spon sored a study to assess the potential de velopmental effects from exposure to hydroquinone. Two-generation reproductive effects testing with rats will be com pleted and the results submitted to EPA before January 1990. Isopropanol date chartered 1987 CURRENT TASK CROC P Toxicology Research PANEL MANAGER Robert Toro CHAIRMAN James Quance Exxon Chemical Americas The Panel developed a research plan for the determination of isopropanol pharmacokinetics in rats and mice, in anticipation of a test rule under TSCA Section 4. Pharmacokinetics studies will be conducted with the rat under the proposed test rule and the Panel will voluntarily conduct a second study with the mouse. Data obtained in these studies should be useful in extrapo lating toxicity data relating isopropanol to specific toxicity endpoints. The Panel formed to address concerns regarding isopropanol raised by the ITC in its 19th Report to the EPA Administrator. The ITC formally designated the chemical for testing under TSCA Section 4 in 1987. The Panel will continue interacting with EPA to resolve any technical problems related to the test rule. The rule is expected in late 1989. Ketones DATE chartered 1980 CURRENT TASK CROUP Toxicology Research PANEL MANAGER Robert Toro CHAIRMAN: James Quance Exxon Chemical Americas The Panel presented oral and written comments addressing health effects and feasibility issues raised in the OSHA proposed rule to amend existing air contaminant standards for acetone. The Panel also submitted petitions to delist methyl ethyl ketone and methyl isobutyl ketone under SARA Section 313. In anticipation of a mesityl oxide rule making under TSCA Section 4, the Panel reevaluated exposure to MO as a sitelimited intermediate in production facilities. The Panel will submit expo sure data to EPA from companies producing MO as a by-product. The Panel formed to address EPA activities on MIBK, MEK, isophorone, and MO under TSCA Section 4. The Panel negotiated testing programs with the Agency to augment the data base on those chemicals. In addition, the Panel was actively involved in discussions with the Agency on testing needs for MO and filed a petition for review of the final test rule. The Panel will respond to the reopening of the MO rulemaking. The Panel also is conducting a review of the EPA IRIS database on ketones and will work with the Agency to update it. Lubricant Additives DATE CHARTERED 1980 CLRRENTTASK CROUP Environmental Research PANEL MANAGER Carol Stack CHAIRMAN Charles Keller Exxon Chemical Company The Panel completed an aquatic toxicity testing program and submitted the results to the Group of Experts on the Scientific Aspects of Marine Pollution for evaluation. The purpose of the program was to provide GE5AMP with adequate data on several classes of lubricant additives for use in assessing potential hazards caused by the chemicals in a marine environment. GESAMP used the results of the testing program to develop appropriate hazard ratings. The IMO Bulk Chemi cal Handling Committee used the ratings to assign the additives to pollution categories. The Panel also partially completed an investigation of the efficient stripping of additives from cargo tanks. Technical difficulties and practical considerations forced closure of this part of the program. The Panel organized to address anticipated international marine pollution control regulations. An immediate concern was the need to generate marine aquatic toxicity data to support proper pollution categories for bulk shipments and to investigate the efficient stripping of unloaded tankers. The Panel reached its initial goals and now is investigating other regula tory arenas where joint company involvement may be beneficial. 14 CMA 030591 Metal Catalysts Methylenedianiline Naphthenates PAH CHARTERED 1984 DATE 1 HARIFRED 1982 DATE CHARTERED 1983 ARREST T \-~k C RL'IP'- ToML'olotfv Research ) Industrial Hu aiene RCRA 'ANcl. ACER i_P AIRMAN Susan Howe \\ dliam Deerine Gulf Chemical and Metallurgical The Panel completed a research program for testing nickel catalysts in i two-cell transformation systems. The | results indicated that nickel catalysts do not induce cell transformation in these 1 test systems. i The Panel formed to collect and evaluate information necessary to assess safety, environmental, and health issues arising from the production, ! storage, transportation, use, and j disposal of metal-containing catalysts | used as heterogeneous catalysts in industrial processes. The Panel has focused on a research program to characterize the toxicity profiles of metal catalysts. Long-range testing plans will be developed after the Panel receives final reports from studies being conducted by EPA and the National Toxicology Program. EPA is conducting a reanalysis of exposure data from previ ous epidemiology studies and the NTP | is conducting long-term inhalation 1 studies on nickel compounds. These reports are anticipated in the fall of 1989 and in 1991, respectively- The Panel will continue its liaison with the Nickel Producers Environmental Re search Association and European : Catalysts Manufacturers Association. i L KRtN T T VsR UROL RA Risk Assessment Anaivtical and Industrial Hygiene Medical and Toxicology RAVEL MAX AGER Elizabeth Moran CHAIRMAN Roger Daniel Dow Chemical L'SA The Panel participated in the negotiation of a workplace standard for MDA under the Occupational Safety and Health Act. The negotiations were the first of their kind and involved a 15person Mediated Rulemaking Committee comprised of three industry representa tives, three union representatives, two government laboratory representatives, and seven government agency represen tatives. The Panel Chairman, Roger Daniel, and two other Panel members represented the industry. The Panel developed data on economic impact and submitted comments on toxicology and risk assessment. A proposed OSHA workplace standard based upon the negotiated agreement was published in May. Although some disagreement remains, the proposed standard meets the needs of OSHA, industry, and labor unions. The Panel formed in response to the Interagency Testing Committee recommendation that 4,4-methylenedianiline be considered for priority testing under TSCA Section 4. In 1983, EPA decided that no additional testing was necessary, but designated MDA as the first "significant risk" chemical under TSCA Section 4(f). Ultimately, in 1985, the Agency referred the chemical to OSHA under the authority of TSCA Section 9. The Panel filed comments follow ing publication ot the proposed workplace standard addressing two major issues which did not reflect the mediated standard. One issue was the lack of a de minimus level for MDA in mixtures which would not be subject to the standard. The second issue involved medical surveillance provisions and pay protection for workers removed for medical reasons The final rule should be published in late 1989, barring any objections to the proposal. CURRENT TASK CROUPS None PANEL MANAGER Has Shah CHAIRMAN Michael Scott Moonev Chemicals. Inc No new activities were under taken by the Panel this year. The Panel formed as a result of a recommendation that calcium, cobalt, and lead naphthenates be considered for priority testing under TSCA Section 4. The Panel has expanded its scope of activities to address EPA concerns in the pesticides area. The Panel will decide on a course of action when it receives the EPA evaluation of a dermal absorption study. The study was part of a volun tary testing program developed by the Panel and the Agency. Oleylamine DATE CHARTERED 1984 CLRRENT TASK GROUPS None PANEL MANAGER, Susan Howe CHAIRMAN Lincoln Metcalfe Akzo Chemie America After EPA issued final test stan dards for the TSCA Section 4 test rule in December, the Panel submitted study plans to the Agency and contracted with laboratories to conduct testing . Testing requirements issued under the final rule include: jri vivo mammalian bone marrow cytogenetics; detection of gene mutations in somatic cells in culture; and, developmental toxicity studies in rabbits and rats. Due to Panel presentations of data and com ments to EPA, the final rule requires substantially less testing than the proposed rule. The Panel formed in response to the TSCA Section 4 proposed rule requiring pharmacokinetics, genetic effects, subchronic toxicity (including neurotoxicity and reproductive tract effects), and teratogenicity data. The Panel will monitor mutagen icity and developmental effects studies. CMA 030592 15 The Panel also will work with EPA to determine it additional studies are necessary to characterize the toxicity potential ot olevlamine. Phosgene r'\TF CM \RTl RtP 1972 cl rrf\t Engineering and Satetv Practices Regulatorv iVkIndustrial Hygiene Medical and Toxicology ''wn, masacfr Robert Romano CHAIRMW w E Irbv Baver USA, Inc in May, the Panel and EPA entered into a cooperative study of fugitive emissions at production facilities. Results of the study show that actual emissions are at least 99.9% less than the Agency's previous estimates. The study results are extremely important and will benefit the industry at large by serving as models for determining or estimating emissions at various types of facilities. Task groups of the CMA Environ mental Management Committee plan to use the study in developing broad industry policies on fugitive emissions. The Panel also initiated a research project at the New York Medical College on treatment methods for accidental exposures to phosgene. The research already has several promising results. The proceedings of the Panelsponsored international symposium, "Remote Monitoring: Current Technol ogy and Future Developments Appli cable to Air Toxics, Including Phos gene," will be published this fall. The Panel continued exploring means to evaluate methods of controlling phosgene releases. A literature search and a preliminary dispersion model were used to advance this effort. The Panel's ultimate goal is to conduct a field evaluation of the model. The Panel formed to improve industry's ability to safely manufacture, handle, and use phosgene. Predicting and controlling ambient concentrations of phosgene from accidental releases has become an important Panel objective. The Panel will continue informa tion exchange and cooperation with EPA, and will monitor other areas of increasing regulatory interest in phos gene. The Panel also plans to develop a phosgene mitigation data base and a held testing program to assess mitigation devices. Phthalate Esters DMfc CHAPTERED 1973 CLRRENTT-VSKCROU^ Toxicology Research Food and Drug Applications Phthalic Anhydride Environmental Research FDA Toxicology Research California Phthalic Anhvdnde Toxicology Research CHAIRMAN James Santory Aristech Chemical Corporation PANEL MANAGERS Elizabeth Moran and Robert Toro The Panel was successful in obtaining two favorable decisions from EPA which greatly reduced reporting requirements under SARA Section 313. First was recognition by the Agency that DEHA-containing plastic wrap meets the definition of an article, which makes the wrap exempt from the reporting require ment. Second, EPA confirmed that solutions containing less than 1.0% DEHA are exempt from reporting. The Agency had published incorrectly a 0.1% cutoff level for the chemical. The Panel's new Phthalic Anhy dride Task Group convinced EPA to remove PA from the T5CA Section 4 test rule requested by the Office of Solid Waste. The Panel demonstrated to the Agency the technical infeasibility of the required test. The PATG also filed a petition to remove PA from the SARA Section 313 list. The California Task Group developed an exposure guideline, which will allow users of DEHP to determine dermal and inhalation exposures from consumer products containing this plasti cizer. Results of exposure determina tions provide guidance to California manufacturers and retailers on whether warnings will be required on their consumer products under the state's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The Panel formed in 1972 to address environmental issues. In 1976, the Interagency Testing Committee listed the alkyl phthalate category for test rule development under TSCA Section 4. The 1TC also included health effects testing in its concerns following the release by NTP of bioassay results on DEHP and di-2ethylhexyl adipate. In 1980-81, the Panel worked with EPA to develop the first Negotiated Testing Agreement in lieu of a TSCA Section 4 test rule. The testing was completed in 1984 and the results were submitted to the Agency along with a proposal for further environ mental testing. In 1988, the Panel and EPA agreed on an environmental testing program, which is being con ducted under a consent order. In light of the NTP data, in 1981 the FDA became interested in the indirect food additive uses of DEHA and DEHP and in 1985, expressed concern about the levels of DEHP reported in some foods. In response to these concerns, the Panel conducted a market survey in which milk, meat, and cheese samples from different regions of the country were analyzed for DEHP content. The level of DEHP in all test foods was within the range of labora tory control samples. The Panel also conducted studies on the pharmacokinetics and liver effects of di-2-ethylhexyl adipate. This program arose from FDA questions on a DEHA bioassay. DEHA remains as an indirect food additive while the Panel conducts research. The Consumer Product Safety Commission investigated exposure to DEHP from a large variety of consumer products in 1982. The Panel provided extensive comments to the Commission in order to narrow the scope of activi ties to children's products that are to be chewed or sucked. Users of the plasti cizer then were able to negotiate a voluntary standard to limit the amount of DEHP in their products. The Panel plans to sponsor research on the environmental effects of phthalate esters. In addition, the Panel will initiate a state advocacy program. The first phase of the program is to identify in three key states any upcom ing regulations and legislation that might involve phthalate esters. The Panel will then develop advocacy activities that will address the issues. If successful, the pilot program will be extended to additional states. The Panel's Proposition 65 advocacy activities focusing on discharge prohibitions also will continue. The Panel will explore alternative cancer risk assessment methods for DEHP. Toxicological Profiles will be available on DEHP (final) and DBP (draft) this year under SARA Title I. The Panel will interact with EPA and ATSDR on identification of research needs. Panel advocacy activities also will continue with FDA, and with EPA on pesticide inert ingredient regulations and safe drinking water standards. In the international arena, the Panel and the CEFIC Plasticizers 16 CMA 030593 j Technical Committee will jointly j sponsor a workshop on phthalate esters, and will cooperate in addressing new regulations. The Panel also plans to conduct advocacy under the new l Canadian Environmental Protection ; Act. The first focus will be on water ! qualify guidelines. Congressional efforts to move PCB regulations from TSCA to RCRA authority have subsided in recent months, but remain a possibility in the 101 st Congress. The Panel will continue to monitor this issue carefully. Specialty Acrylates/ Methacrylates date chartered, 1987 CLRREXT TASK CROC PS Scientific Issues Membership Regulatory Issues Polychlorinated ! Biphenyls : [nrtCilARTFREP 1981 current r\^ku,roup*? None 'WEL MANAGER Elizabeth Cormley CHAIRMAN John Craddock Monsanto Company The Panel continues to address PCB issues as part of a consensus group which includes the Edison Electric Institute Utility Solid Waste Activities Group, the National Electrical Manu facturers Association, the American Public Power Association, the Associa tion of American Railroads, the Environmental Defense Fund, and the Natural Resources Defense Council. In cooperation with industry, the Panel: encouraged Congress to allow EPA time to complete work on a notification and manifesting rule; provided j testimony and data to California's ! Science Advisory Panel on reproductive : toxicity and carcinogenicity; and, provided follow up to New Jersey regulators on spill cleanup issues. The services of toxicological consultants were employed in many of these j efforts. I The Panel formed to represent the j interests of the industry during imI plementation of the TSCA Section 6 regulations for the control of PCBs. To date, the Panel has addressed inadver tent generation of PCBs, mitigation of transformer fires, and retention of electrical equipment containing PCBs. ! In addition, the Panel has focused on ; disposal and storage requirements, and the cleanup of accidental spills. The Panel continues to monitor SARA activities and is awaiting the release by ATSDR of the revised Toxi cological Profile. EPA actions on the storage/disposal proposed rule and drinking water criteria issues also are being monitored. Panel actions to address individual state activities are expected to increase in the coming year. Rubber Additives PANEL MANACERS, Elizabeth Moran and Robert Toro DATE CHARTERED 1979 CURRENT TtekCROlP Toxicology Research CHAIRMAN Geor|ean Adams Minnesota Mining and Manufacturing Company The Panel reached agreement with r\\Ei manager Henrv Sauer CHAIRMAN Bernard Hill Monsanto Company EPA on a comprehensive research program covering all acrylates and methacrylates on the TSCA inventory. The agreement contains a three-stage program in which the Panel will conduct specific testing at each stage. In return, the Agency agreed to revi The Panel initiated testing of 2- sions in some of the more restrictive mercaptobenzothiazole under TSCA provisions of the TSCA Section 5 Section 4. Joint test sponsors included consent orders for the new chemicals. the Motor Vehicle Manufacturers Prior to the agreement, manufacturers Association and more than fifty other were required to label all new acrylates importers of rubber articles containing and methacrylates as potential carcino MBT. EPA audited and accepted the gens based upon structure-activity rela Panel's voluntary pharmacokinetics tionships to existing chemicals. This studies. and other provisions of the orders The Panel formed to support research restricted distribution and impeded that would expand the rubber additives successful marketing. In addition, EPA safety and health issues data base. To had considered issuing a comprehen date, the Panel has collected information sive test rule under TSCA Section 4 on approximately 65 chemicals classified which could have required extensive as rubber additives, and has sponsored toxicology testing on the existing more than 5800,000 in research. chemicals in the category. The Panel will continue to collaborate The Panel formed to address EPA with the German consortium, WTR, in concerns about new and existing efforts to monitor, review, and sponsor 1 specialty acrylates and methacrylates. health and safety studies on rubber The Panel's major emphasis is on additives. The two groups will co ; working with the Agency to remove sponsor health studies in the coming restrictions on the development and year. Most of the Panel's MBT studies j marketing of new products. Current under TSCA Section 4 will be completed : Panel membership consists of produc by October 1989. Reproductive effects ers, importers, formulators, and users studies will be completed by March 1991. of these chemicals. The Panel now will begin to conduct the first tier of toxicological tests. The Panel also will initiate discussions with EPA on the development of a generic acrylates Significant New Use Rule, which will eliminate the need for TSCA , Section 5(e) orders. i CMA 030594 17 Titanium Dioxide DATE CHARTERED 1977 CLRRENT TASK GROLTS None TANEL MANAGER Susan Howe Trimellitate Esters Vinyl Chloride DATE CHARTERED 1983 DATE CHARTERED 1973 cirrenttasrcroet Toxicology Research CURRENT TASK CROLP Research Coordinator CHAIRMAN Jerry Blacker 5CM Corporation PANEL AlANACER Elizabeth Moran CHAIRMAN Dean Finney Eastman Chemical Company PANEL MANACER Susan Howe CHAIRMAN William Gaffev Monsanto Company In January, EPA published a The Panel completed a battery of The Panel asked an independent Notice of Proposed Rulemaking re environmental and health affects tests on expert to clarify the results of aTanel- questing comments on its proposed tn-2-ethylhexyl tnmellitate as part of a sponsored epidemiologic study on designation of 232 chemicals as Negotiated Testing Agreement under vinyl chloride workers. The study extremely hazardous substances under TSCA Section 4. The Panel submitted showed excess mortality from tumors CERCLA. Titanium tetrachloride is results to EPA in 1986 and has been not previously associated with vinyl among the substances designated by awaiting a response from the Agency. chloride -- non-angiosarcomas -- and the Agency. The Panel submitted The ITC designated the trimellitate biliary tract tumors. Panel scientists comments on the Agency's proposed for priority testing under TSCA Section 4 : suspect that these tumors may actually regulation, which would affect the in 1982. The recommended testing be misdiagnosed angiosarcomas. The reportable quantity for this chemical. included metabolism, subchronic, mut expert encountered difficulties in The Panel specifically requested that agenicity, and environmental effects gathering histopathologic specimens for EPA establish an RQ of 1000 pounds in testing. The producers immediately , re-examining the cause of death associ its final rule designating TiCl4 as a formed a special task group under the ated with vinyl chloride. The Panel CERCLA hazardous substance. As an Phthalate Esters Panel and subsequently now is pursuing different means of alternative, the Panel asked that the one formed the Panel to pursue a negotiated gathering these specimens. pound statutory RQ be waived until testing agreement. The Panel reached an The Panel formed to accumulate and such time as the Agency adjusts the RQ agreement with EPA in 1984. assess health and safety data on vinyl on a scientific basis. The Panel awaits a When EPA completes its review, chloride monomer. After funding response from EPA. the Panel will work with Agency several animal studies, emphasis on The Panel continued its information- scientists in interpreting the test data and i research shifted from toxicological in sharing sessions in which member determining the need for additional vestigations to early diagnosis and company representatives discuss case testing. clinical management of injuries. histories involving accidental releases Subsequently, the Panel has focused on and safety problems encountered with epidemiologic studies of workers. TiCl4. The companies hope to enhance worker and community safety by sharing key experiences and improve ments made to control releases. , The Panel formed to address concerns about the potential hazards confronting workers in the complex atmosphere created during formulation operations with titanium dioxide. The Panel will continue to work with the National Cancer Institute on its proposal for an epidemiologic study on TiCI4 workers. Panel members re quested that NCI await the results of DuPont's ongoing efforts to collect ad- \ ditional smoking information on its ! worker cohort before determining j whether an additional epidemiology j study is necessary. i Member companies plan to monitor j the EPA proposal to regulate mining j wastes and assess its impacts on the I titanium dioxide industry. The Panel I also will track regulations in states that have added, or plan to add, titanium i dioxide to their hazardous substances lists and will petition for delisting 1 i ! where necessary. 18 CMA 030595 Vinylidene Chloride DATE CHAPTERED 1974 ALRRENT TASK GROUP Toxicology Research 'axel manager Barbara Francis Water Additives PATE CHARTERED 1985 CURRENT TASK CROUP1- Specific Chemicals c HAIRMAX Zeb Bell PPG Industries. Inc. PANEL MAX ACER Robert Romano chairman Paul Carlson Calgon Corporation The Panel continued its efforts to have EPA withdraw the proposed TSCA Section 4 test rule. The Office of Air Quality Planning and Standards has stated that further testing of VDC is unnecessary. Nonetheless, the EPA Test Rules Development Branch will not withdraw the rule until after ATSDR has evaluated and published the final Toxicological Profile on VDC under SARA Section 110. The Panel submitted comments to ATSDR in May as part of its continuing effort to assist the Agency in evaluating the chemical. The Panel formed to sponsor research on the potential toxicologic effects and pharmacokinetics of VDC. The objective was to develop data for ensuring the safety of workers involved in manufacture, handling and use, as well as the safety of communities surrounding production facilities. The Panel will continue to work with ATSDR and EPA to achieve reasonable regulations based on sound scientific information. The consensus Water Additives Standards are complete. By law, certifications of all additives must occur by mid-1990. Because certifying organi zations and procedures are not con firmed, the Panel continues to work with various organizations seeking to develop an acceptable certification program. The Panel also encouraged EPA to be an active party in developing the certifica tion process. In addition, the Panel is working with the American Water Works Association which, in the last phase of the process, will compile a list of all chemicals that are certified against the standards. The Panel formed a task group for each of the following chemicals: polydiallyldimethylammonium chloride j (PDADMAO; copolymers of epichlo- ` rohydrin and dimethylamine (EPI/ DMA); and, polyacrylamide (PAM), Each task group will perform an expo sure assessment and fill appropriate j toxicology gaps. j The Panel formed to address regula tions of direct and indirect potable water additives. The objectives are to monitor regulatory policies, improve communica tion, review toxicology data, develop advocacy positions, ensure that any water additive program is designed and administered in a cost-effective manner, and ensure that water additives are used in a manner that does not compromise public health, safety, or the environment. The Panel will continue to work with all organizations that are developing water additive certification programs. The Panel also will participate in American Water Works Association activities where the programs are further discussed and defined. CMA 030596 Table [ CHEMSTAR PANELS FINANCIAL STATUS For the Twelve Months Ended May 31, 1989 Panels Balance 6/1/88 Contribution Receipts Acrvlates/Methacrvlates Alkanolamines Alkvlphenols and Ethoxylates Aromatic Diamines Arsenic Benzene Biocides Butadiene Butylated Hvdroxytoluene Chlorine Dioxide Chlorobenzenes Cresols Crystalline Silica Cumene Cvclohexane Dibenzofurans/Dibenzodioxins Diisocyanates Epoxy Resins Ethylene Dibromide Ethvlene Dichioride Ethylene Glycol Ethylene Oxide Ethylhexanol Ethylhexanoic Acid Fluoroalkenes Fluorocarbons Glycol Ethers Hexamethvlene Diisocyanate Hydrogen Fluoride Hvdroquinone/Quinone Isopropanol Ketones Lubricant Additives Metal Catalysts Methylenedianiline N'aphthenates Oleylamine Phenol Phosgene Phthalate Esters Polychlorinated Biphenyls Rubber Additives Titanium Dioxide Trimellitate Esters Vinyl Chloride Vinylidene Chloride Water Additives TOTAL $ 51,600 72,100 162,300 1,000 20,700 562,300 313,800 164,700 22,600 29,700 421,000 311,600 -049,900 (3,200) 35,400 -02,200 -06,200 199,000 285,700 125,900 43,700 506,600 2,623,600 486,300 -0-075,300 (4,900) 36,200 86,000 107,100 50,400 900 85,700 -0150,500 745,200 27,300 16,400 27,100 18,700 39,500 (8,700) 11,700 $ 7,959,100 $ 353,800 -0- 269,300 -0-0-0- 1,036,800 136,400 40,000 38,000 673,400 287,400 36,000 890,800 64,800 60,000 150,000 -0-01,200 152,100 141,300 1,104,400 163,500 702,900 1,343,700 731,900 15,000 17,500 154,600 322,200 180,000 -038,000 -0-077,800 35,000 208,200 860,900 145,200 416,100 30,000 -0-015,000 16,000 $ 10,919,200 Interest Revenue $ 16,400 4,600 22,600 100 600 36,700 50,400 7,800 1,200 1,700 41,000 24,600 200 25,700 1,100 1,600 4,500 100 -0-015,600 25,700 50,600 900 42,800 182,800 52,200 600 600 9,800 (600) 900 4,900 6,200 4,000 -09,400 500 14,400 60,600 3,200 9,600 2,400 1,500 2,800 (1,700) 600 $ 741,200 Expenditures Balance 5/31/89 $ 136,900 37,600 81,700 -018,000 151,700 619,200 194,000 27,100 82,500 669,200 293,000 16,400 532,400 58,600 83,300 65,900 1,900 -0- 11,200 162,800 217,600 718,400 169,200 829,800 1,791,700 541,700 3,800 10,900 153,100 105,300 271,900 53,800 85,100 3,800 800 72,900 5,500 152,000 807,600 66,000 330,700 35,200 1,400 11,200 26,500 21,700 $ 9,731,000 $ 284,900 39,100 372,500 1,100 3,300 447,300 781,800 114,900 36,700 (13,100) 466,200 330,600 19,800 434,000 4,100 13,700 88,600 400 -0(3,800) 203,900 235,100 562,500 38,900 422,500 2,358,400 728,700 11,800 7,200 86,600 221,400 (54,800) 37,100 66,200 50,600 100 100,000 30,000 221,100 859,100 109,700 111,400 24,300 18,800 31,100 (21,900) 6,600 $ 9,888,500 20 DMA 030597 FINANCIAL RESOURCES ach panel is required to maintain a CASH COMPENSATING BALANCE which recognizes Ethat CMA signs all contracts on behalf of the panels and assumes the financial liability for panels meeting their contractual commitments. The balance permits timely honoring of finan cial commitments. The combined compensating balance for all CHEMSTAR Panels at the beginning of Fiscal Year'88-89 was about $8 million. Compensating balances on May 31,1989 totalled about $9.9 million. On this date, CMA had financial liabilities totalling about $11 million under 298 executed contracts on behalf of the various panels. INTEREST on the unexpended cash balance provides supplemental revenue for each CHEMSTAR Panel. This year, panels earned a combined total of approximately $740 thousand in interest income. EXPENDITURES of CHEMSTAR Panels are based on budgets approved by each panel. In Fiscal Year '88-89, panels spent a collective total of $9.7 million for research, consultants, legal counsel and panel management. Figure 1 CHEMSTAR PANELS Financial Allocations ADVOCACY FY 1987-88 Advocacy 44% Research 56% RESEARCH FY 1986-87 Advocacy 40% Research 60% CMA 030598 21 Figure 2 CHEMSTAR PANELS" Submissions to Government Agencies 1977 78 79 80 81 82 83 84 85 86 87 88 `89 Metal Catalysts Panel meeting with Japanese Metal Catalysts Industry Association 22 CMA 030599 REGULATORY AFFAIRS uring the year, 42 CHEMSTAR Panels focused their efforts on regulatory issues. Panels sub Dmitted comments on pending regulations, and research data, to many federal, state and interna tional agencies. Of all federal agencies, EPA received the greatest attention from panels. TSCA Section 4 is the chief concern of 21 panels. The emergence of environmental regulations of individual chemicals continued, causing increased panel attentions to the Clean Air Act, SARA, Safe Drinking Water Act, and RCRA. FIFRA concerns also accelerated as an area of panel activity. Among other federal agencies, the Agency j for Toxic Substances and Disease Registry, Food and Drug Administration, Occupational Safety and Health Administration, National Toxicology Program, and the National Cancer Institute once again caused panel actions. Among state agencies, the California Department of Food and Agriculture attracted the most panel activity. This attention was due to Proposition 65 implementation and data call-ins on industrial chemicals. Of the international agencies, the United Nations Environment Programme, U.S. Depart ment of State, International Maritime Organization, and the Food and Agriculture Organization/ World Health Organization were again significant panel focuses. Figure 3 CHEMSTAR DIVISION Staff Time Allocations CMA 030600 23 Phthalate Esters Panel Research Symposium Figure 4 CHEMSTAR PANELS Summary of Research Expenditures 24 CMA 030601 RESEARCH hirty-seven CHEMSTAR Panels sponsored research projects in 1988-89. Contracts for research Tincreased dramatically from the previous year to 298 separate agreements. Research efforts again included a strong emphasis on health effects studies. Toxicological re search involved subchronicjchronic, mutagenicity, teratogenicity, oncogenicity and pharmacokinetics studies. Several panels investigated direct effects on humans through epidemiology and clinical re search. Risk assessments and exposure surveys also were important, being undertaken by nearly a quarter of all panels. Environmental studies continued to expand this year, demonstrating a continued increase of interest in air and water regulations. Several panels initiated testing required under TSCA Section 4. In most cases, the testing programs are multi-year, large-scale efforts that include many decision points where government and industry scientists must interpret data and decide on next steps. Just as importantly some panels completed their required testing and received acceptance from EPA. As in previous years, some panels voluntarily sponsored research to fill data needs. "Proactive" research of this kind continues to be an important part of the CHEMSTAR Panels' scientific efforts. Figure 5 CHEMSTAR DIVISION Summary of Contracts Managed 1976 ;77 78 79 80 81 82 83 84 85 86 87 '88 '89 CMA 030602 25 GUIDANCE HEMSTAR Policy Committee Purpose: The Committee ensures that all CHEMSTAR Panels Care conducted in a manner consistent zoith Association policy, and with the CHEMSTAR Guidelines; counsels with the panels regarding new and revised operating needs; and, reviews and makes recommendations on advocacy activities on individual chemicals when requested by a panel or staff. CHEMSTAR Policy Committee Chairman - Earnest W. Deavenport, Jr. Eastman Kodak Company Vice Chairman * Ernest Drew Hoechst-Celanese Corporation Earnest W Deavenport, Jr. Ernest Drew Geraldine V. Cox Vice President-Technical Director CMA Gary C. Herrman Vice President-Treasurer CMA David F. Zoll Vice President-General Counsel CMA Geraldine V. Cox Gary C. Herrman David F. Zoll Staff Executive - Langley A. Spurlock Director, CHEMSTAR Division CMA Figure 6 Summaries of Principal Guidance Statements for the CHEMSTAR Panels CHEMSTAR PANEL OPERATING PRINCIPLES The Principles present the geneial statement of policies and procedures for operation of all CHEMSTAR Panels. They address: Panel Authorization Participant Financial Obligations Research Output CHEMSTAR GUIDELINES The Guidelines provide details of policies and procedures that are generally stated in the Operating Principles. This document is the primary reference for specific operations of panels and the CHEMSTAR Division. Topics covered include: Panel Initiation Procedures Membership Criteria Responsibilities of Panel and Task Group Participants Financial Administration and Budgeting Contracting Procedures Information Handling 26 CMA 030603 MANAGEMENT SERVICES A s issues, objectives and locations of effort multiply, management of the CHEMSTAR Panels becomes ever more challenging for panel and task group chairmen. This year, as in the past, a broad array of CMA services was employed to ensure that panels receive adequate support for their operations. CHEMSTAR Leadership Session Leadership Training The annual CHEMSTAR Lead ership Session was held in October, and attended by ten panel leaders. The Sessions are designed to assist chairmen in resolving the dilemmas of leading diverse and changing organi zations. Sessions are invitational, oneday workshops primarily held for new panel and task group chairmen. Participation by experienced chairmen also is welcome and sought. At the Sessions, a training specialist from a CMA member company provides advice on persuasive leadership, and peers share experiences in dealing with related problems. Because par ticipant ratings continue to be high, another Session is planned for fall 1989. Communications Ensuring industry awareness of panel activities and other important specific chemical regulatory and research developments remained a high priority for the CHEMSTAR Division. CHEMSTAR NEWS, a quarterly publication with a circula tion of 1,500, is the Division's princi pal means of reaching a broad industry segment. The NEWS points out upcoming regulatory impacts on specific chemicals, summarizes recent actions of various panels, lists panel reports and agency submissions, and highlights significant changes in panel membership. Through the "Spot light" article in each issue the accom plishments of individual panels are summarized. This year, the Titanium Dioxide, Ethylene Oxide, Specialty Acrylates/Methacrylates and Ketones Panels were featured. The CHEMSTAR Alerts, published as needed, are the Divi sion's means of quickly informing panel members and others in the industry when a time-sensitive response is needed on a chemicalspecific issue. Subjects in Alerts vary CMA 030604 27 from a pressing need to submit infor Director mation to an agency, to the need for joining other companies in a response to a regulatory deadline. In 1988-89, Langley A. Spurlock, Ph.D., CAE the Division issued five Alerts on a diverse range of topics. Dr. Spurlock completed his seventh year as Director of the CHEMSTAR Division Staff Division in June. He is responsible for oversight of all panels. The CHEMSTAR Division re sponded to this year's increase in panel activities by expanding the management staff and assigning new responsibilities to existing managers. Susan Howe filled a newly created position as Senior Panel Manager, bringing the managing staff to ten persons, all with technical degrees. The total staff complement now is 24. Barbara Francis also joined the managing staff this year as Panel Manager, replacing Kathryn Rosica who was promoted to Associate Director in CMA's Health and Safety Division. In recognition of her superior achievements, Elizabeth Moran was promoted to Associate Di rector within the CHEMSTAR Division. Reflecting the Division's increased needs for accounting activities, the CMA Accounting Office created the position of Assistant Con Dr. Spurlock is a Certified Associa tion Executive, awarded by the American Society of Association Executives. Before joining CMA, he held an appointment in the U.S. Government Senior Executive Service at the National Science Founda tion. During his tenure at NSF he served as Senior Staff Associate for Operations, Directorate for Mathematical and Physical Sciences, Special Assistant to the Director, Office of Planning and Re sources Management, and as Oversight Coordinator and Special Assistant to the Director, Office of Audit and Oversight. Previously, Dr. Spurlock received an appointment as U.S. Department of Health, Education and Welfare Fellow, and served as Special Assistant in the Immediate Office of the Secretary of HEW. Earlier, he was Assistant to the President at the American Council on Education. Before coming to Washing ton, Dr. Spurlock held an appointment as Associate Professor of Chemistry at troller for the CHEMSTAR Division. The position was filled by Elizabeth Bergan. Brown University and earlier was j Assistant Professor of Chemistry at Temple University. Previously he served as Senior Research Chemist in the General Chemical and Agricultural Chemical Divisions of Allied Corpora tion. Dr. Spurlock received a Ph.D. in Organic Chemistry from Wayne State University. 28 CMA 03060 Associate Directors Hasmukh C. Shah, Ph.D., D.A.B.T. Elizabeth J. Moran, Ph.D. Dr. Moran joined CMA and the CHEMSTAR Division in 1981. She continued this year as manager of the panels on methylenedianiline, phthalate esters, specialty acrylates/ methacrylates, and tnmellitate esters. Dr. Moran is a biochemist and Board Certified Toxicologist. She is currently on the Editorial Board of the Journal of Toxicology and Environ mental Health. Before coming to CMA she was a program manager at JRB Associates. Earlier, Dr, Moran directed the Flavor Safety Program at International Flavors and Fragrances, Inc., where she was responsible for toxicological testing on new chemi cals. Previously, Dr. Moran con ducted lipid nutrition research at the U.S. Department of Agriculture and was a visiting professor at the University of Maryland. Dr. Moran received a Ph.D. in Biochemistry from the University of Maryland. Dr. Shah joined CMA and the CHEMSTAR Division in 1979. He is responsible for management of the programs on biocides, 2-ethylhexanoic acid, and naphthenates. Dr, Shah is a Board Certified Toxicologist. Before coming to CMA, he was the Director of the Toxicology and Biomedical Sciences Department of Equitable Environmental Health. He was also the Project Director for the Na tional Institute for Occupational Safety ; and Health's criteria document project, and for the "Profiles on Occupational Hazards for Criteria Document Priori ties." Previously, at the Stanford Re search Institute, Dr. Shah was a Project Coordinator, and served as a Senior Toxicologist. He previously was a Visiting Fellow Scientist at the National Institute for Environmental Health Sci ences. Dr. Shah received a Ph.D. in [ Pharmacology and Toxicology from the ! University of Rhode Island. j Carol R. Stack, Ph.D. Robert R. Romano, Ph.D. j Dr. Stack joined CMA and the Dr. Romano joined CMA in 1980 as a manager in the Environ- i j CHEMSTAR Division in 1980 and was promoted to Associate Director in 1985. She is currently responsible for manage mental Division where he was responsible for the water and air ment of the panels on benzene, chlo robenzenes, ethylene glycol, glycol programs. In February 1985, he joined the CHEMSTAR Division as an Associate Director. He continued this ethers, lubricant additives, and hexamethylene diisocyanate. Before joining CMA, Dr. Stack was year as manager of the programs on ethylene dibromide, ethylene oxide, phosgene and water additives. employed in the Toxicology and Bi omedical Sciences Department at Equitable Environmental Health where Recently he also assumed manage she served as an Assistant Project ment of the panels on chlorine dioxide EHrector responsible for the preparation and diisocyanates. of NIOSH multi-chemical criteria Dr. Romano came to CMA from the U.S. Nuclear Regulatory Commis documents. Earlier, she served as Visiting Scientist at the Neurological sion, where he worked as an Associ Institute in Bogota, Colombia, where she ate Project Director. Previously he worked on a school fluoridation investigated central auditory pathways in echolocating birds. Dr. Stack received a project for Indiana State Board of Ph.D. in Biology from New York Health. He has also taught at Del Mar University. College and American University. Presently, Dr. Romano is an adjunct Environmental Engineering Professor at George Washington University and teaches a course in environmental management. He received a Ph.D. in Environmental Sciences from Purdue University. CMA 030606 29 Senior Panel Managers Elizabeth Festa Gormley, B.A. Ms. Festa Gormley joined CMA and the CHEMSTAR Division in 1983. She is responsible for the management of the fluorocarbons, dibenzofurans/ dibenzodioxins, polychlorinated biphenyls, hydrogen fluoride, and crystalline silica panels. Prior to joining CMA, she was Section Staff Executive with the National Electrical Manufacturers Association, where she was respon sible for the Nuclear Magnetic Resonance Imaging Section with the Diagnostic Imaging and Therapy Systems Division. Previously, Ms. Festa Gormley worked in the Endo crine Biochemistry section of the Na tional Institute of Arthritis and Metabolic Disease at the National Institutes of Health, and held the position of Research Chemist at both the CENTEC Corporation and Radian Corporation. She was also a recipient of a National Science Foundation Assistantship. Ms. Festa Gormley earned a B.A. in Chemistry from Albertus Magnus College. Process Emission Regulations, Manager of the Insurance Committee, and Man ager of the CHEMSTAR Panel on Benzene. He is responsible for manage ment of the panels on alkanolamines, alkylphenols and ethoxylates, cyclohexane, ethylene dichloride, ethvlhexanoic acid, hydroquinone, and rubber additives. He also is actively involved in management of the panel on fluorocarbons. Before coming to CMA, Mr. Sauer had chemical industry experience in sales, marketing research, applications research and commercial development. Just before joining CMA, he was the Develop ment Manager, Fine Chemicals Group, Great Lakes Chemical Corporation. Earlier he was employed at PPG Indus tries as Marketing Research Representa tive in the Industrial Chemical Division, and as Assistant to the Sales Manager and Technical Sales Representative in the Coatings and Resins Division. He previ ously served as First Lieutenant in the U.S. Army Corps of Engineers. Mr. Sauer holds an M.B.A. from the Univer sity of Pittsburgh, and a B.S. in Chemical Engineering from Carnegie Mellon University. Susan R. Howe, M.S. Ms. Howe joined CMA and the CHEMSTAR Division staff in June 1989. She is responsible for the management of the butylated hydroxytoluene, metal catalysts, olevlamine, phenol, titanium dioxide, and vinyl chloride panels. Before coming to CMA, Ms. Howe was a Product Safety Representative for the Mobay Corporation. Previ ously, she was a Regulatory Specialist with Ruetgers-Nease Chemical Company. Ms. Howe holds an M.S. degree in Food Science and a B.A. in Science from The Pennsylvania State University. Henry J. Sauer, MBA ; j | ! I ; I Mr. Sauer joined the CHEM STAR Division in 1986. He had been Manager of the CMA Energy and Engineering Section since 1984, and the Energy Committee Staff Executive since he joined CMA in 1977. At CMA he also has served as Manager of the Solid Wastes Managem nt Committee, Manager of the Environmental Management Committee Task. Groups on New Source Performance Standards for Industrial Boilers and j | ! j j ' CMA 030607 Panel Managers Legal Counsel Assistant General Counsel Barbara O. Francis, MBA Ms. Francis joined CMA and the CHEMSTAR Division staff in March 1989, She is responsible for the man agement of the panels on cumene, cresots, fluoroalkenes, dinitrotoluenes, and vmyhdene chloride. Before joining CMA, Ms. Francis was with Interspan Inc. Previously, she was a product planner for Hoechst Celanese, Inc. Ms. Francis holds an M.B.A. from Virginia Polytechnic Institute and State University and a B.S. in biology and chemistry from Bishop's University in Quebec, Canada. Robert Toro, M.S. Mr. Toro joined CMA and the CHEMSTAR Division staff in May 1988. He is responsible for manage ment of the panels on isopropanol and ketones. He also manages the Phthalate Esters and Glycol Ethers Environmental Research Task Groups, and the Specialty Acrylates/Meth acrylates Scientific Issues Task Group. Before coming to CMA, Mr. Toro was the Quality Assurance Director of Tegeris Laboratories. Previously, he was employed as a toxicologist and Quality Assurance Officer at Gillette Medical Evaluation Laboratories. Mr. Toro received a M.S. in physiology from the University of Maryland. The panels were strongly assisted by the CMA Legal Department in antitrust, contract, research and regula tory areas. Reflecting the importance and complexity of panel issues, a CMA attorney is assigned full-time to the affairs of CHEMSTAR Panels. To ensure that antitrust protection is consistently maintained, CMA attorneys counselled panel chairmen, as well as all Division staff on proper procedures. As usual, staff attorneys reviewed all panel com ments, contracts, reports, agendas, and minutes as part of routine protective measures. In research, the assigned CMA counsel intensively supported Division managers in drafting and negotiating the nearly 300 contracts let this year with laboratories and consult ants. In advocacy, the CMA counsel supervised the activities of outside coun sels retained by the panels. The CMA counsel provided advice on regulatory activities and ensured that member company legal counsels were informed of significant developments. Marilyn D. Browning, J.D. Ms. Browning joined the CMA Legal Department in 1987 as the staff attorney for CHEMSTAR Panels. This year she received a promotion and now represents CHEMSTAR Panels as assistant general counsel. Ms. Browning reviews and provides counsel in production of all substan tial panel documents including con tracts, regulatory comments, legisla tive correspondence and testimony, filing in litigation, and press releases. In addition, she counsels panel mem bers and staff on antitrust prevention and supervises outside attorneys who serve individual panels. She also serves as counsel to the Chemical Control Task Group of the CMA International Affairs Committee. Before coming to CMA, Ms. [ Browning was in private practice with Augustine and Kern Ltd. of Chicago, . representing private and corporate clients. Prior to her legal career, Ms. j Browning owned and managed a service agency specializing in fashion advertising. Earlier, she was an in structor of grades K-9. Ms. Browning I is a member of the Illinois and District j of Columbia Bars. She holds a B.S. j from the University of Illinois and a j J.D, from the Illinois Institute of Techj nology, Chicago Kent College of Law. CMA 030608 31 DIVISION MANAGERS Cbckwise, from bwer left to right: Elizabeth Moran, Elizabeth Gormley, Hasmukh Shah, Carol Stack, Henry Sauer, Langley Spurlock, Susan Howe, Robert Romano, Robert Toro, Barbara Francis 32 CMA 030609