Document BRyvppbXeXzopVGV90j7wnqpj

J ii t ! ,t A REPORT ON THE YEAR 1986-1987 4 SPECIAL PROGRAMS A ,-- ? . *- =. _V "V TV - W\. v . ^Wf| - -T psg?^ - ... *.,< / T" kVa . n j', '-J ' - 41 - *. #V*I. 'i*-** ,; *f .''A*l. -T. - ^*. `vk -ji-**'*\J*"Vii*... ' l,~ - f a :v-r?g w^: v--jj'i-' ' -T^, j jjj m* SPECIAL PROGRAMS The Biomedical and Environmental Special Pro grams provide a mecharaan for companies that wish to jointly conduct research and/or advocacy on spe cific chemicals. Research is conducted to collect scientific information which will promote the health and safety of those insolved in the manufacture, processing use and dispo sal of chemicals. All final reports and other sipnficant findings of CMA-managed research programs are released to the public. Advocacy is conducted to facilitate external commu nications (not designed solely for information ex change) that relate to existing or develops regula tions. legislation or litigation. THE PROGRAMS Alkanolamines Arsenic Benzene Biocides Butadiene Butyizted Hydroxy- toluene Chlorobenzenes Crcsols Cumene Cyclohexane Dibenzofurans/ Dibenzodioans Epoxy Resins Ethylene Dibromide Ethylene Dichloride Ethylene Glycol Ethylene Oxide Ethythexanoic Acid 2-Ethyihexanol Fluorocarbons Glycol Ethers Hydroqumone/ Quinone Isopropanoi Ketones Lubricant Additives Metal Catalysts MethylenedamUne Naphthnates Octytpbenoi Oteyiamine Phosgme Phosphorus Phthalate Esters Polychlorinated Biphenyls Rubber Additives Toluenediamines Titamum Dioxide Trtmeilitate Esters Vinyl Chloride Vmyiidene Chloride Water Additives CONTENTS 1 Overview 3 New Programs 5 Continuing Programs 17 Financial Resources 19 Regulatory Affairs 21 Research 22 Guidance 23 Division Staff CMA 030517 OVERVIEW cceleration - aptly describes the feelings of panel members and Division staff this year while Aconfronting the waves of new regulatory activity. If last year gave glimpses of the regulatory future for individual chemicals, this year provided action-packed previews. In particular; mas sive new testing programs are on the horizon. Coming events for Special Programs were much in evi dence among federal and state laws, such as SARA and California's Proposition 65. TSCA and FIFRA data call-ins on large numbers of chemicals and broad-scale concerns under TSCA about the health and environmental effects of structurally related chemicals likewise indicated that more and larger testing will be required soon. All the while, the main feature -- comments on current regulations and ongoing testing of products -- moved panels faster toward regulatory resolution. In short, the year presented all of the challenges that we expected . . . and more. Fast Times To cope with the expanding regula tions, Special Program panels met more frequently with agency staffs, filed more comments, presented more testimony and initiated more research. Adding to the action were new pro grams that required intensive member company resources for planning and organizing in their start-up phases. Not surprisingly, financial and person nel commitments by member compa nies to existing and new programs were considerable. Direct contact hours by the Special Programs Divi sion staff, a measure of program ac tivity, were up by 9% over last year. Further additions to the resource-consuming load were the es sential activities of coordination and coalition building. This year, more than ever, the focus was on coordina tion of industry positions among vari ous panels, among panels and CMA committees, and among panels and other associations. The efforts of many company personnel, with a vari ety of skills, ensured that consistendy strong industry positions are being de veloped to address multi-chemical reg ulations under TSCA, RCRA, FIFRA, the Safe Drinking Water Act and the Clean Air Act. Likewise, panel members de voted much effort to building coali tions with trade associations and envi ronmental groups in interactions with EPA, OSHA, the Department of State ___ _ 1 and the United Nations Environment Programme. Some of these coalitions have already produced sensible, costeffective solutions to regulations, and others are nearing this goal. Media coverage of Special Program chemicals was unabated. Television, radio and press interests in various chemicals resulted in a large number of inter views by panel members as well as Division staff. In addition, panels con structed many press releases to ad dress the well-publicized concerns. While some long-standing issues re main controversial, most concerns were relieved through presentations of credible data by thoroughly prepared industry spokesmen. Panels now are focusing more frequently on planning and training of spokesmen for media coverage. Managing At High Speed The Special Programs Division took several vital steps to support the mul tiple directions of the programs. High priority remained on coordination of panel activities with other groups in side and outside CMA. The Associate Directors continued their roles as principal coordinators for Special Programs interests with the Health and Safety Committee and the Envi ronmental Management Committee. In addition, other Division staff undertook assignments as coordinators for Special Programs concerns with CMA task groups addressing RCRA. SARA and state regulations. The new assignments reflect the wider importance of specific chemical issues in the scheme of regulations addressed by agencies and the Associ ation. The Division coordinators en sure that impending regulations come to the attention of all potentially af fected panels as soon as possible, with suggestions on actions to take. Coordinators also make sure that ap propriate standing committees are aware of the effects of current or upcoming regulations on specific chemicals and the panels' proposed responses. Dovetailing of the Associ ation's generic and specific chemical comments on regulations is a prime objective. As always the Division was strongly assisted by the CMA Legal Department in antitrust, research, and regulatory areas. To ensure that antitrust pro tection is consistently maintained, CMA attorneys counselled panel chair men, as well as Division staff on pro per procedures and reviewed all panel comments, reports, agendas, and min utes as part of routine protective measures. In research, CMA counsels increasingly supported Division staff in negotiating effective contracts with laboratories and consultants. Rapid, informative communication of important regulatory and scientific developments also was a prime effort for the Division. The Special Pro grams Newsletter, now in its third year of publication, still receives ac claim from its audience for coverage of panel activities and new influences on specific chemicals. Hie "Spot light'' article in each issue ensures that overall accomplishments of indi vidual panels are regularly summa rized and publicized. The Special Programs Alerts continue as quick means of informing panel members and others when a time-sensitive re sponse is needed to protect company interests. Alert subjects vary from the pressing need to submit data or com ments to an agency, to the need to join other companies in a combined response to upcoming regulatory deadlines. Valuable input for CMA standing committees also came from responses to Alerts. All the while, CMA News, ChemEcology and the Presi dent's Letter performed their usual important roles in publicizing activ ities of Special Programs to a wide audience. The Special Programs Leadership Session, begun experimentally last year, became a full-fledged component in the Division's array of services. The Sessions are one-dav workshops, held primarily for new panel and task group leaders. The goals are to pro vide advice from peers and an indus try training specialist on persuasive leadership; to provide an overall view of CMA; and, to foige a bond between leaders with like interests. Ratings by this year's participants were high, and as a result, another Session is in the planning stage. Looking Forward We are certain that 1987-88 will at least equal and probably exceed this year's formidable pace. A stimulus to this prediction was the appearance this year of several regulations with testing and reporting requirements for large numbers of chemicals. Sections of SARA now have potential for caus ing large-scale testing of many chemi cals some of which are the focuses of Special Programs. We expect increased activity by the affected panels first in collecting, analyzing and submitting data, and later in planning and spon soring research. The Clean Air Act. RCRA and the continuing implementa tion of Proposition 65 also seem probable as generators of new Special Programs, as well as contributors to existing panel activities. And . . in the midst of all this action, testing under TSCA Section 4 test rules will be initiated for more Special Programs chemicals than ever before. Based on past experiences and good planning, we have confidence that our successes will continue into June 1987 2 CMA 030519 NEW PROGRAMS uring 1986-87, four new Special Programs were requested and approved. Manufacturers and Dusers of three individual chemicals -- Ethylene Glycol, 2-Ethylhexanol and Isopropa nol -- and one chemical category -- Aromatic Diamines -- organized programs to address testing needs. Impetus for formation of the new programs differed among the groups. In the first instance, manufacturers simply had a proactive interest in expanding the toxicological data base on their product. In the next two cases, the companies faced upcoming mandated testing requtements under TSCA. The driving force for the fourth program was a concern about the extent and types of EPA-required testing of new products in a category. All four panels are now fully organized and pro ceeding toward their initial objectives. AROMATIC DIAMINES R. Smith Ethyl Corporation Derr Chartered.1987 Current Tmk Group) Toxicology Research Program Manager. C. Stack/K. Rosica CMma Manufacturers of aromatic diamines are developing new products with various sub stituents on the aromatic ring. As pan of the TSCA Premanufacture Notification pro cess, EPA has required that each of the new products be tested for carcinogenicity because of structural similarities to 2.4toiuenediamine. a known rodent carcino- ln February. CMA responded rabiy to a request from the manufac turers to establish a special program for addressing the problem of extensive pre marketing testing requirements. The Panel's primary goal is to develop a strategy acceptable to EPA for achieving PMN approvals without the need for a long-term bioassay on each new product. At present, very limited structure-activity data exist to refute EPAs assumption that all substituted aromatic diamines are po tentially carcinogenic. The Panel is planning research to address the question of how substitution on the aromatic diamine ring affects carcinogenic potential. ETHYLENE GLYCOL 0. Macauley Union Carbide Corporation Date ramm<, 1986 Current Tmk Group, Toxicology Research C. Stack The Program was formed to clarify and expand the toxicological data base on eth ylene glycol. Panel-sponsored research was initiated recently. Pharmacokinetics and material balance studies in rats, and a dermal developmental toxicity study in mice, are being conducted at the Bushy Run Research Center. When the final reports are available, the Panel will review the results of the studies and decide where to direct future research, fossible projects include exten sion of the pharmacokinetics program to include mice, and conduct of oral teratolo gy studies in rats and mice to establish No Observed Effect Levels. CMA 030520 3 2-ETHYLHEXANOL Chairmans R. Wise Inion Carbide Corporation Dale auncmt 1986 Current Ttmk Groups Toxicology Research Proemn Managers E. Moran Budget cuts forced the National Tbxicoiogy Program to cancel a two-year rat and mouse bioassay planned for 2-ethyihexanoi. NTP requested that EPA require in dustry to sponsor this testing by issuing a test rule under TSCA Section 4. EPA agreed to develop a proposed rule in six months, with a final rule to be published six months later. The Panel formed to address the pend ing test rule. The Panel developed a bioassay test program including additional dose groups and measurements in order to understand the biological effects of 2-EH. EPA rejected the Panel s program and will publish a final rule soon requiring only traditional bioassay testing. The Panel will conduct the testing re quired under the rule and will interact with EPA on a second proposed test rule. The second rule may include pharmacoki netics, teratology and reproductive effects testing. A use and exposure survey is be ing conducted by the Panel to aid devel opment of relevant test protocols and to ensure that only necessary additional test ing is required. ISOPROPANOL Chair--rate J. Quance Exxon Chemical Americas One ChMrtered198" Csirrent Tank Groups Toxicology Research Program Managers K. Rosica The Panel is actively involved with EPA in developing a negotiated consent agree ment for health effects testing of isopropanol under TSCA Section -t. In re sponse to intent-to-designate status with the inter- agency Testing Committee, the Panel proposed a testing program to EPA and awaits reactions from the Agency, if negotiations succeed, this will be among the first consent agreements effected un der the new EPA procedural rules for Sec tion 4. The Panel formed to address concerns raised by the ITC in its 19th Report to the EPA Administrator. Designation for testing of isopropanol was included in the 20th Report released in May. 4 CMA 030521 CONTINUING PROGRAMS orty Special Programs are now officially approved by CMA Each sanctioned program oper Fates under a charter which defines its scope within the framework of the Association s gener ic interests. At year's end, four new groups await official approval -- Alkylphenols and Ethoxylates, Chlorine Dioxide, Fluoroalkenes, and Specialty Acrylates and Methacrylates. Special Prog rams membership rosters during the year included 185 companies and nine associations. Among the company members, 83 were members of CMA and 15 were non-U.S. and non-Canadian. Participating companies and associations were represented on panels and task groups by approximately 290 per sons with professional skills ranging from physical and biological sciences, through engineering and industrial hygiene to legal and business areas. ALKANOLAMINES Chairman: Bentley Texaco Chemical Company Date Chartered: 1982 Current Toll Group Toxicology Research Program Manager; H. Sauer Summaries of panel-sponsored pharmaco kinetics studies on triethanolamine are to be published in Brownings'. "Toxicology and Me tabolism of Industrial Solvents." When the Panel presented these results to the National Toxicology Program, the NTP staff stated that the data will be used in shaping future re search efforts. The Panel formed to sponsor toxicology studies on triethanolamine in order to re spond to concern raised by a Japanese study that implicates this chemical as a possible carcinogen. The Panel has tentatively planned research on other alkanola mines and is monitoring additional NTP research programs on triethanolamine, including 90-day subchronic dermal testing. Recently, the NTP completed a 90-day subchronic dermal testing with triethanola mine and now has the chemical under review for further testing. The Panel is following these efforts as a guide to its own future testing. ARSENIC Chairman: D. McGtaw Hoppers Company Dale Chartered; 1981 Current Tank Groups: None Program Manageri H. Shah The Panel convened a meeting with repre sentatives of OSHA and EPA at which Dr. Adam Taub of the University of Uppsala pres ented his epidemiologic research findings on Swedish smelter workers Taubs study and earlier Panel-sponsored studies investigated whether a threshold exists for respiratory can cer related to the extent of exposure to arse nic. While the study showed that men hired before 1938 had almost twice the risk of those hired from 1938 to 1936. Taub s analy sis gave no dear evidence of an exposure threshold. The Panel then hired a consulting firm to conduct alternative exhaustive anal yses of the epidemiologic data to resolve the threshold issue. The Panel was formed to address the im pact of OSHA and EPA regulations on various companies manufacturing or using arsenic, and to sponsor appropriate research. In gen eral. the Panel has accomplished its goals and objectives. Any additional frnel activities will depend on whether the epidemiological anal yses indicate an arsenic threshold for respira tory cancer. BENZENE Chairman: R. Daniel Dow Chemical ISA Date Chartered. 1976 Current Taak Group Toxicology Research Program Manager; C Suck In March 1986. the Panel was active in OSHA hearings on the proposed reduction of the workplace standard for occupational expo sure to benzene. In June, the Pane) filed post-hearing comments and submitted a clos ing brief to OSHA The proposal, if adopted, would reduce the permissible exposure limit from K) ppm TWA8 to I ppm. with an "action level" of 0.5 ppm. The action level serves as a trigger for medical surveillance and air monitoring requirements. The Panel also ac tively opposed a legal challenge to EPAs final rule on benzene fugitive emissions and the Agency's decision to forego final rules on ben zene emissions from ethylbenzene/styrene op erations, storage vessels, and maleic anhy dride production facilities. A decision is ex pected soon on the case pending in the IS. Court of Appeals. District of Columbia. Since its initiation, the Panel has pursued an active research and advocacy program. Re sponding to a NIOSH occupational study Unk ing benzene exposure to leukemia, the Panel initiated an industry epidemiology study that was completed in 1983. Also, in cooperation with the American Petroleum Institute, a joint animal toxicology research program was es tablished that produced studies examining benzene subchronic toxicity, metabolism, and possible reproductive effects. The Panel actively participated in the 19" OSHA proceedings to lower the current workplace standard and was a party in the 5 CMA 030522 subsequent legal challenge of the I ppm PEL established by OSHA in I978. The 10 ppm standard was upheld in a landmark Supreme Court decision in 1980. An OSHA Final Rule is anticipated in June 198". The Panel will review the provisions of the rule and then decide on future activities. BIOCIDES Chairman: J 'rtister Troy Chemical Corporation Date Chartered: 1986 Ciurenr Task Groups: Regulators Litigation Scientific Specific Chemicals Program Manager: H. Shah The Panel continued to address testing is sues associated with the California Depart ment of Pood and Agriculture Data Call-in on biocidal chemicals. The Panel also ex panded its focus to address or monitor the following issues at the federal level: EPA Antimicrobial Data Call-In: EPA Pesticide Inerts Policy: F1FRA Registration Fees: and, FIFRA reauthorization. For the Antimicro bial Data Call-In. the Panel submitted comments outlining legal, technical, and economic problems. Specific end-use ex posure assessment groups were formed by the Panel to develop the protocol for as sessment. In addition, the Panel filed comments on EPA's proposed rule estab lishing fees for various pesticide registra tion activities. The Panel continued the attempt to persuade regulators at state and federal levels to distinguish industrial biocides from agricultural biocides when establishing regulatory controls. The Panel stated that the potential for human expo sure to industrial biocides is limited and markets for these chemicals are small. Thus, extensive regulation has a much greater economic impact on these manu facturers and is unwarranted. The Panel was formed in 1986 when the California Department of Food and Agricul ture issued Data Call-In Notices on biocidal chemicals registered in the state. The notice required that registrants submit data on chronic toxicity, oncogenicity, re productive effects, teratogenicity, mutagen icity and neurotoxicity. Manufacturers of many affected chemicals formed the Panel to address issues associated with this regu lation and any other regulatory actions affecting biocides. The Panel will remain active in shaping the EPA Antimicrobial Data Call-In. The new Liugation Task Force will address sig nificant legal issues. The Panel also will monitor developments in the EPA Inerts folicy and other aspects of FIFRA reau thorization. The Panel s specific chemical task forces affected by the California Data Call-In may sponsor research as necessary. An EPA Special Data Call-In will cause the Arsenic Acid Task Forte to sponsor both glove and protective clothing permeability and teratology studies. BUTADIENE ChAinDMfe J. Bonin Shell Chemical Company Date Chartered: 1984 Current Task Groups- Toxicology Research Environmental Industrial Hygiene Program Manager; R. Romano in January, the Panel submitted comments to OSHA on the Advance Notice of Proposed Rulemaking for 1.3-butadiene. The Panel then sponsored a tour of two butadiene plants for OSHA staff. In preparation for the proposed rule, the Panel sponsored an indus trial hygiene survey of butadiene producers. This survey will be expanded to include crude butadiene producers and stand-alone termi nals. Exposure data from the survey also will be used in updating workplace risk as sessments. In March, the Panel participated in EPAs National Air Pollution Control Tech niques Advisory Committee hearing on the "intent to list butadiene as a Clean Air Act Section 112 hazardous air pollutant. The Panel stressed that realistic data should be used in esumaung butadiene fugitive emis sions. In the aftermath of an EPA TSCA SecUon 4(f) consideration, the Panel formed to collect and evaluate informauon needed to assess the safety, environmental and health issues arising from production, stor age. transportation, use or disposal of 1,3butadiene. The Panel provided comments to EPA on two risk, assessments, and worked with the Agency in assessing the 'short-term'' releases of butadiene. The EPA has referred butadiene under TSCA Section 9(a) to OSHA. The Panel will review and comment on the "intent to fist" proposal expected soon from EPA. In the coming year, the Panel also will actively follow development of the listing decision by the ERA and OSHA workplace standard. BUTYLATED HYDROXYTOLUENE CAutiraftftr J. Zora Neville-Synthese Organics Date Chartered: 1977 Current Task Groups: None Program Manager: H. Shah In June, the Joint Expc Food Additives of the Food and Agricultur al Organization/Worid Health Organization lowered the temporary acceptable daily in take level for BHT. Additionally, JECFA re quested information on the hepatocarcinogenicity of BHT in rats and the hemorrha gic effect of BHT in susceptible species. The Panel will generate the requested in formation with European manufacturers of BHT. As a first step, the Panel is review ing current literature on the hemorrhagic effect, and European manufacturers are de veloping information to help understand the mechanism of hepatocarcinogemcity. In December, the Panel filed a Citizen Petition with FDA requesting that the Commissioner issue a regulation recogniz ing a prior sanction for the use of BHT. The Panel has monitored scientific evalua tion of BHT safety in food products for 6 CHA 030523 the past decade. Submission of the Petition represents a request by the Panel that the FDA officially recognize the safety of BHT under the framework for regulation of food ingredients set forth in the Federal food. Drug and Cosmetic Act. The Program was, in fan, begun to con duct research and advocacy necessary to support continued use of BHT in food ad ditive applicauons. In 19"'. FDA pub lished a proposal for interim regulations requiring testing to resolve safety ques tions on BHT. The Panel filed comments on the FDA proposal in I978. The Panel will cooperate with FDA in its current evaluation of BHT and may devel op addiuonal scientific information, if ap propriate. The Panel also will continue its relationship with European manufacturers m developing information requested by JECFA CHLOROBENZENES chairman: J Bryant Standard Chlorine Chemical Co.. Inc. DM Chartered: 1974 Current Talk Group: Toxicology Research arntnan Program Manager: C. Stack EPA issued a TSCA Section 4(a) Final Rule in July requiring health effects testing for chlorobenzenes. The Panel complied by initiating studies on 1.2- and U-dichlorobenzene, 1,2.4-trichlorobenzene, and 1.2.4,5-tetrachlorobenzene. In a separate rulemaking published in April 1986, EPA required environmental effects testing of dichlorobenzenes and trichlorobenzenes, but the Agency has yet to finalize the test standards for the testing. The Panel con tinued providing technical support to the Chlorobenzenes Producers Association, an affiliate of the Synthetic Organic Chemical Manufacturers Association. in particular, the fond and CPA have focused on regulatory proposals for 1,4dichlorobenzene. tositive findings in an NTP study prompted the Panel, in coor dination with CUT. to investigate the rela tionship of tumor types found in bioassavs to human risk assessment. The Program was formed to sponsor re search on chlorobenzenes. The Panel has completed investigations on the mutagenic potential of these chemicals, as well as re search on developmental toxicity. The Panel's TSCA testing program will extend through January 1991. Panelsponsored research on 1,4-dichlorobenzene will begin in the coming year. CRESOLS Chairman: J. Walbridc Merichem Company Date Chartered: 1984 Current Talk Group Toxicology Research Pwigmn Manager: K. Rosica The Panel submitted comments to EPA in June on the proposed standards for tesung required on cresols under TSCA Section 4. Under this rulemaking, testing will be initiated once the standards are fi nalized. The panel-sponsored testing, spanning a two-year period, will inwfve genetic, reproductive and developmental effects studies. Since coming to CMA. the Panel has worked with EPA's Test Rules Development Branch and Office of Solid Waste, and the National Toxicology Program to ensure that logical and scientifically sound testing programs are conducted on cresols. Panel membership now includes foreign import ers as well as domestic producers. Initiation of the testing is anticipated shortly. CUMENE Chairman- G. Van Getder Shell Chemical Company Date Chartered: 1984 Current Talk Group!: Toxicology Research Mutagenicity Chatman Program Managers: K Rosica/C. Suck The Panel completed an extensive ge netic testing program on cumene and will soon submit the results to EPA The Agen cy will use these data in developing a final test rule under TSCA Section 4. The testing was undertaken to clarify results of pre vious tests which were considered to be technically invalid. The Program was formed because of the November 1984 Interagency Testing Com mittee designation of cumene for priority testing. The Panel s objective is to ensure that ERA has sufficient data to make an in formed decision on health and environ mental effects testing. Final TSCA rulemaking is expected by the end of 1987. Initiation of environ mental and health effects testing under the rule is planned for 1988. CYCLOHEXANE flulHMHt R. Cook Phillips Chemical Company Date Chartered: 1985 Current Tank Groupai Toxicology Research User Exposure Survey H. Sauer A Panel survey of the U.S. producers and major users indicates that cyclohexane basically is used in closed systems with monitored workplace exposures near I ppm TWAS. The OSHA standard is 300 ppm TWA8. Now the Bute! is surveying smaller users to obtain more complete information on potential exposure risk. The Panel was CMA 030524 7 unsuccessful in negotiating a consent order testing agreement with EPA. Manufacturers formed the Program in 1985 to address the ITC intem-to-destgnate cyclohexane for priority testing under "RCA Section 4. The chemical was formally designated in 1986. Despite EPAs determination that muta genicity data are adequate and negative, it appears that EPA will require full health effects testing, including carcinogenicity, because cyclohexane is produced m large volume The Panel is preparing to com ment on the proposed TSCA test rule. DIBENZOFURANS/ DIBENZODIOX3NS Chairman- k. Burgess The Dow Chemical Company Date Chartered: 1984 Current Task Groupi Technology- Program Manager-. C. Suck Panel activities included, comments on EPAs Health Assessment Document on . Dibenzofurans and Toxicity Equivalence Factor scheme for risk assessment: and, involvement in an international informa tion exchange on dioxins and related chemicals sponsored by the NATO Commit tee on the Challenges of Modem Society. EPA, and the Panel as an intervenor, received a favorable federal court decision in a lawsuit filed by environmental groups. The suit sought reversal of EPAs denial of a petition to initiate TSCA Section 6 rulemaking on dioxins and furans. The de cision. handed down in March, affirmed era's "right to set its own priorities" and held that the burden rests with the peti tioner to demonstrate that a rule is re quired to protect against an unreasonable health or environmental risk. The Program was formed in 1984 when the Environmental Defense Fund and the National Wildlife Federation submitted a petition to EPA under TSCA Section 21 which requested regulation of all sources and media containing furans or dioxins. EPA shortly will publish a final rule un der TSCA Sections 4 and 8 that will re quire analyses of h chemicals for the presence of dibenzofurans and dibenzodioxins as impurities. The .Agency also will issue a rule under TSCA Section 8 that will require submission of production, process, use. exposure, and disposal data on chem ical products made from 12 precursor chemicals to determine if there is a need for analysis of the products. The Panel submitted comments on the proposed rule in February 1986. Future Panel activities will address the anticipated TSCA rules and possible actions related to the court decision. Continued participation in the CCMS project is planned. EPOXY RESINS Chairman.- H. Flegenheimer lmeithem. Inc. Date Chartered: 1981 Current Teak Group Toxicology Research H. Shah No new activities were undertaken by the Panel this year. Earlier, the Panel col lected and evaluated production, use, ex posure. environmental release and health effects information on epoxy diluents rep resented in the category, "gtycidol and its derivatives." In 1984, the Panel submined this information to EPA in response to the Agency's Advance Notice of Proposed Rulemaking, which sought guidance on how to select representative chemicals from this large and complex category. The Interagency Testing Committee des ignated the category for priority considera tion by EPA under TSCA Section 4 in 1978. Testing for carcinogenicity, muta genicity. teratogenicity, other toxic effects and epidemiology were recommended. The Panel still awaits a response from EPA. ETHYLENE DIBROMIDE Chairman: V VChite Great Lakes Chemical Corporation Date Chattered: 1982 Current Task Groups: None Program Manager: R. Romano The Panel is waiting to review an OSHA final rule revising the Federal Occupational Standard for EDB. The rule is imminent, but since it has not been issued, the Panel has had no need to meet this year. The Program was formed to address the OSHA standard and its goal is to ensure that reasonable regulations are adopted. Once the OSHA rule is issued, the Panel will review the requirements and deter mine the effects on the industry. ETHYLENE DICHLORIDE Program Manager: R. Romano The Panel participated in the EPA Clean Air Act Section 112 NAPCTAC hearing last fall. The hearing addressed the Agency's generic Hazardous Organic NESHAP and "intent to list" eight chemicals, including EDC. The Panel opposed EPAs fugitive emissions estimates and questioned health data used to evaluate EDC. The Panel's concerns with EPA Safe Drinking Water Act regulations were incorporated into general comments, filed by the Environmental Management Committee s Safe Drinking Water Act Task Group. The Program was formed to voluntarily sponsor an EDC toxicology study. The Pane) has focused on evaluating current literature, identifying data gaps, and un dertaking additional toxicological studies to improve the EDC data base. In addi tion, the Panel has sponsored research studies on chronic inhalation, metabolism, and teratogenicity. 8 CMA G30b25 The Panel will continue to work with the EPA Office of Air Quality Planning and Standards to ensure that the proposal to regulate EDO emissions is realistic. EPA's intent to list" decision is due shortly. The Panel will review the proposal and provide comments. The Panel will also track Safe Drinking Water Act regulations of EDC in the coming year. ETHYLENE OXIDE Chairman: R \an Mvnen Inion Carbide Corporation Date Chartered: 1981 Current Task Groups.Scientific Toxicology industrial Hygiene Economic Environmental Risk Assessment Chairman Program Manager: R. Romano In October, the Ethylene Oxide Industry Council presented testimony at the EPA NAPCTAC hearing. The testimony focused on concerns with the Agency s "intent to list" EtO as a hazardous air pollutant un der the Clean Air Act Section 112. The EOIC Environmental Task Group has worked closely with the EPA Office of Air Quality Planning and Standards to docu ment EtO emissions. The EOIC also en tered into the NRDC vs. EPA "intent to list lawsuit as an amicus. The EOIC Industrial Hygiene Task Group conducted a workplace survey of EtO producers. The survey results plus other nsk assessment data will be provid ed to OSHA to assist development of EtO Short Term Exposure Limit. The Task Group also is sponsoring research to es tablish a STEL equivalency reference meth od for EtO monitoring. In support of these activities, the EOIC prepared an in-depth hazard assessment on EtO that was published by CRC Publications in December. The Clean Air Act Section 112 Hazard Air Pollutant listing decision is expected soon from EPA. The EOIC plans to review and comment on the outcome, in addi- uon. the EOIC will address the OSHA pro posed STEL due next spnng, through com ments and participation in hearings. Also, the EOIC will track closely the implemen tation of California's Proposition 65. since EtO is included in the priority list of chemicals to be regulated. The EOIC was formed to evaluate the results of an animal study that may affect OSHA and EPA regulatory programs. In volved in many regulatory and scientific activities, the EOIC Committees and Task Groups have worked to provide both Agen cies with information to make reasonable and scientifically sound decisions on regu latory controls. 2-ETHYLHEXANOIC ACID Chairman: R. Gerwe Tennessee Eastman Company Date Chartered: 198-4 Current Taak Group: Toxicology Research Program Manager. H. Sauer The Panel asked for judicial review of EPA's finding that EHA "may present an unreasonable risk" within the context of TSCA testing provisions. The Panel feels that the requirements are not supported by "substantial evidence." The Ui. Court of Appeals denied the Panel's request for a stay of the testing pending completion of review proceeding. The Panel, therefore, initiated the TSCA testing program recently in order to meet testing deadlines in the final rule. In 1984. the fTC designated 2-ethvihexanoic acid for priority tesung under TSCA Section *. Following this designation, the Program was formed and began submitting data to EPA that documented the use and manufacturing processes associated with EHA Since EHA is used solely as a chemi cal intermediate, and is manufactured and processed in closed systems, the Panel has focused on demonstrating that there is no significant human exposure. The TSCA testing program should be completed by June 1988. Studies include oral and dermal pharmacokinetics testing, oral subchronic testing, and oral devel opmental toxicity studies. The fudicial re view decision is still of concern to the Panel, due to the precedent-setting nature of the ERA testing decision. Also, the deci sion may affect any additional testing im posed by EPA FLUOROCARBONS Chairman: R. Orieo Allied-Signal Corporation Date Chartered: m Current Taak Group* Atmospheric Sciences Effects External Affairs Oilman Program Manager E. Connies' The international regulatory community is showing increasing concern over the role that chlorofluorocarbons play in mod ifying the stratospheric ozone layer and contributing to the greenhouse' effect. The United Nations Environment Program me is developing a protocol to regulate CFC production under the Convention for the Protection of the Ozone Laver. In April, a tentative agreement was reached for developed countries to: cap production of some CFCs at 1986 levels by 1990: re duce production by 20% two years later: and. consider further reductions up to 50%. A firm agreement, for discussion by UNEP's diplomatic conference, is expectl in September 1987. The l'.S. Congress. ERA, and Department of State actively favor an eventual 95% phase-out. Produc tion levels for developing countries are still being drafted. Settlement of a suit filed by the Natural Resources Defense Council against EPA in 1984 was postponed to allow completion of the UNEP protocol. EPA now has until December 1987 to announce whether additional regulations are needed. A Final Rule is to be announced by August 1988. Meanwhile, Congress continues to focus attention on this issue by hosting hearings and introducing bills, in May. Chairman S. Robert Orfeo testified at a House of Rep resentatives hearing about research that the Panel cosponsored with NASA NOAA and NSF on ozone changes in Antarctica. The Program was formed to fond re search on the environmental effects of CFG. To date, the Panel has supported over S19 million of research. Sponsored studies have addressed: atmospheric chemistry: atmospheric measurements: modeling: and. trend analysis. Since 1974, the Panel's efforts have largely centered CMA 030526 9 on the ozone depletion theory. In recent years the program has broadened to in clude monitoring developments in the cli mate/greenhouse and bio-effects areas. In the coming year the Panel plans to fund research on: the mechanisms of the Antarctic ozone depletion phenomenon: heterogeneous and new chemistry: and. fu ture and present day atmospheres. The Panel also will provide seed money for de velopment of a Network for the Detection of Stratospheric Change. GLYCOL ETHERS Chairman: R. Wise Union Carbide Corporation Date Chartered; 1980 Current Task Groups.Toxicology Research Industrial Hygiene Program Manager: C. Stack Response to TSCA Section 4 rulemaking dominated Panel activities. EM published a proposed test role on triethylene glycol ethers in May 1986 and a proposed nile on diethylene glycol butyl ether in August. The Panel filed comments in response to both proposals. The Panel then initiated the mutagenicity testing on DGBE that was proposed by EPA. In December. OSHA responded to EPA's TSCA Section 9(a) referral of 2-methoxyethanol. 2-ethoxyethanol and their ace tates. OSHA preliminarily concluded that occupational exposures at the current per missible exposure limits may present a sig nificant health risk, and that adoption of a revised occupational standard is economi cally and technologically feasible. OSHA initiated rulemaking by publishing an ANPR in April. The Program was established to develop an adequate toxicity data base, provide in formation to users and government agen cies on the safety of the chemicals, and promote scientifically sound regulatory ac tion. The Panel has addressed these issues and continues to build on its accomplish ments. A series of panel-sponsored sub chronic and teratology studies on various glycol ethers served as indicators of com parative toxicity. EPA recently informed the Panel of in terest in imitating the consent agreement process for testing of TGEs. The Panel will be a principal party in the discussions. Fu rore Panel activities also include ftirther tesung of DGBE. when EPA issues the final rule, and response to the OSHA ANPR. HYDROQUINONE/QUINONE Chairman: R. Brothers Eastman Kodak Company Date Chartered: 198-4 Current Twit Group; Toxicology Research Program Manager: H. Sauer The final EPA test role for hvdroquinone under TSCA Section 4 re quires oral and dermal pharmacokinetics studies, developmental toxicity, two-gener ation reproductive testing and neurotoxicity studies. The Panel worked closely with EPA to develop and update fi nal test standards, in addition, the Panel recommended to EPA that hvdroquinone be deleted from the listing of acutely toxic chemicals under SARA Title 111 because the relevant animal effects data do not satisfy the proposed listing criteria. The Program was formed in response to the proposed TSCA Section 4 test rule published by EPA in 1984. Subsequently, the Panel submitted extensive comments to EPA and participated in the rulemaking hearing. The Panel also voluntarily spon sored a study to assess the potential developmental effects from exposure to hvdroquinone. Panel comments describing these results were submitted to EPA. The Panel's testing program under TSCA Section 4 will begin after final test stan dards are published. The testing program is scheduled to be completed within 29 months from the effective date of the test guidelines. KETONES J. Quance Exxon Chemical Americas Date Chartered: 1980 Current Task Groups. Toxicology Research Progrui Manager: C. Stack Chairman The producers challenged EPAs Final Test Rule on Mesityl Oxide under TSCA Section 4. Legal proceedings in the Fifth Circuit Court of Appeals dominated the Panel's activities over the past year. The MO producers also filed a District Court suit challenging EPAs denial of a petition to withdraw the rule: however, the Court granted a request for a stay of the pro ceedings until the Appeals Court case is decided. The decision in the mesityl oxide case is expected to have a major impact on foture TSCA Section 4 rulemakings. Three major issues in the case are: 1) Is EPA re quired to provide substantial evidence of human exposure in order to find that a chemical may present an unreasonable health risk? 2) Can EM consider use of a chemical as a confined industrial interme diate to support a test rule? 3) Is expo sure to a material used in herbicide manu facture a legitimate concern in this con text. or should the chemical be excluded from coverage under TSCA' The Program was formed to address EPA activities on methyl isobutyl ketone, methyl ethyl ketone, isophorone, and mesityl oxide under TSCA Section 4. The Panel negotiated testing programs with EPA to address the Agency's concerns about the first three ketones. Results were submitted to EPA and Agency scientists have expressed satisfaction with the data. Oral arguments in the MO case are scheduled in July. A decision will follow shortly. The Panel may be required to start testing if EPA finalizes the test stan dards for the test role before the decision, unless the Court allows a stay. Because regulatory activities on other ketones are pending, the Panel will continue to moni tor activities on methyl isobutyl ketone, methyl ethyl ketone, and isophorone. LUBRICANT ADDITIVES Chairman C. Keller Exxon Chemical Company Date Chartered: 1980 Current Task Group: Environmental Research MARPOL Efficient Stripping Program Manager: C. Stack The Panel completed ar aquatic toxicity testing program on several classes of lubri cant additives and submitted the data to the Group of Experts on the Scientific As pects of Marine Pollution. GESAMP pre pares hazard profiles on bulk chemicals in marine transport. The profiles are used by the International Maritime Organization s Bulk Chemicals Handling Subcommittee as the basis for assignment of pollution categories. The categories figure promi nently in recently implemented 1MO regu lations governing disposal of tanker resi dues. Research also was completed to show that lubricant additives, although viscous, can be efficiently stripped from ship tank surfaces. The Panel worked closely with the I'.S. Coast Guard on the efficient stopping issue and the assignment of ap propriate pollution categories. Liaison with the European Additives Technical Commit tee and CEF1C continues. The Program was organized to address anticipated international marine pollution control regulations. An immediate concern was the need to generate marine aquatic toxicity data to support proper shipping classification. Another topic that has brat addressed by the Panel is the classification of mixtures. The 1M0 Subcommittee assigned, for the most pan. unfavorable pollution cate gories to lubricant additives based on con servative GESAMP hazard profiles. The Panel, therefore, is addressing GESAMP s concerns and deciding on further testing. A Coast Guard position paper addressing the efficient stripping issue will be presented to the 1MO Subcommittee shortly. If ap proved. the Panel will develop protocols for the required ship tank testing. METAL CATALYSTS Chairman: B Knight tinted Catalysts. Inc. Date Chartered. I98-* Current Task Group: Toxicology Research Industrial Hvgiene RCRA Program Manager: H. Shah The Panel approved a toxicology re search program on nickel catalysts. The program, which includes testing 'generic'' catalysts in two cell transformation sys tems at two laboratories, will begin in September 1987. The Panel also began ex ploring with Dr. Carlo Tamburro of the University of Louisville the feasibility of establishing an occupational health surveil lance system for catalyst workers. Tamburro has successfully developed such a system for other chemicals used in in dustrial settings. The Program was formed to collect and evaluate information necessary to assess safety, environmental and health issues arising out of the production, storage, transportation, use and disposal of metalcontaining catalysts as heterogeneous cata lysts in industrial processes. The Panel's objectives include a research program to characterize the toxicity profiles of metal catalysts. Results from the cell transformation studies will help in determining the need for testing, if any. m the near future. Long-range tesung plans will be developed after the Panel has received final reports from the National Toxicology Program's ongoing long-term inhalation studies on nickel compounds, and EPA's ongoing re analysis of exposure data from previous epidemiology studies. These reports are anticipated in 1989. MFTHYLENEDLAN1UNE R. Daniel Dow Chemical ISA Due Chartered: 1982 Current Task Group: Risk Assessment Medical and Toxicology Analytical and Industrial Hygiene Avfnfli MMiftri E. Moran The frnel is participating in negotiation of a workplace standard for MDA under the Occupational Safety and Health Act. The negotiations are the fitst of their kind and involve a 15-person Mediated Rulemaking Committee. The Committee is comprised of three industry representa tives. three union representatives, and rune government agency representatives. The CMA representative. Roger Daniel, is also the Panel Chairman. The other two indus try representatives were appointed by trade associations that also are members of the Panel The Committee has met monthly to dis cuss toxicology, risk assessment, workplace practices, medical surveillance and eco nomic impact. The Panel developed data on economic impact and prepared com ments on toxicology and risk assessment. Although some areas of disagreement re main, the Committee has developed a workplace standard that meets the needs of OSHA. industry, and labor unions. The Committee Report is due to be published this July. The Program was formed in response to the HC recommendation that 4.9 -methylenedianiline be considered for health and environmental effects testing under TSCA Section A. In 1983, EPA decided that no additional testing was necessary, but desig nated MDA as the first "significant risk" chemical under TSCA Section a (f). Ulti mately in 1985, EPA announced its deci sion to refer MDA to OSHA. under referral authority provided by TSCA Section 9. Following publication of the Mediated Rulemaking Report, OSHA will have 30 days to issue the workplace standard as a proposed rule. Although OSHA is not com mitted to adopt the Committee-developed standard, the proposed rule is not expec ted to deviate much from the recommen dations in the Report. Barring objections to the proposal, the final rule will be pub lished by the end of 1987. The Panel will comment on the proposed rule only if it differs from the mediated standard. CMA 030528 11 NAPHTHENATE METAL SOAPS Chairman; M. Scon Mooney Chemicals. Inc. Date Chartered: 1983 Current Task Groups None Program Manager- H. Shah Chairman In .April, the Panel received from Shell Oil Company the final report of a study under taken by Shell. U K., to evaluate the toxi city potential of an oil addiuve product that contained calcium naphthenate and calcium carbonate in mineral oil. The study results were submitted to EPA by Shell and the Panel. The Program was formed as a result of an ITC recommendation that calcium, co balt and lead naphthenates be considered for testing under TSCA Section a for ef fects on human health and the environ ment. Since then the Panel has expanded its scope of activities to include addressing EPA concerns in the pesticide area. The Panel will decide on a course of ac tion when it receives EPA's evaluation of a dermal absorption study that the Panel conducted. The study' was part of a volun tary testing program that the Panel worked with EPA to develop. The Panel also awaits a response from the Agency on its com ments concerning the need for additional testing of copper and zinc naphthenates under FIFRA OCTYLPHENOL Chairman: R. Keener Rohm and Haas Company Date Chartered: 1983 Current Task Groups: None Program Manager: H. Sauer Under a TSCA Section 4 agreement, the Panel submitted a final report to EPA on the results of an environmental effects study which involved early-life-stage rain bow trout. The study confirmed a maxi mum acceptable toxicant concentration range and identified the no-observed effect level. In 1982. the ITC designated octylphenol for priority consideration bv EPA under TSCA Section a and recommended studies on health and environmental effects and chemical fate. The Program was formed to respond to ERA'S request for this informa tion. The Panel will sponsor a chronic life cy cle test with rainbow trout to complete the series of studies under a voluntary ne gotiated testing agreement with EPA Re cently, the EPA Office of Solid Waste ex pressed an interest in regulating the dies of chemicals to which octylphenol belongs. The Pand plans to join with producers of nonyiphenol and alkyiphenol ethoxylates to form a new Special Program for a coordi nated industry response to EPA regulation of the class. OLEYLAMINE ChMirmmai L Metcalfe Akzo Chemie America Dme Chartered: 198a Current Task Groups: None Program Managed H. Shah Discussions with EPA continued in this year on the proposed test rule for oleylamine under TSCA Section a. The Agency now is alert to the complex problems in volved in testing this chemical due to its highly corrosive nature and cytotoxicity. EPA therefore, requested suggestions from the Panel on a feasible research program for subchronic and mutagenicity testing. The Panel has provided these suggestions and awaits the Agency's response. The Program was formed in response to EPA's TSCA proposed rule requiring data on olevlamine in the areas of pharmacoki netics, genetic effects, and teratogenicity. The Panel will continue working with EPA in developing a scientifically sound testing program. PHOSGENE Chairman: V. Irby Bayer USA Inc. Date Chartered. 19-' Current Task Groups: Engineering and Safet) Practices Industrial Hygiene Medical and Toxicology Regulatory. Program Manager: R. Romano The first year of the Panel-sponsored research project on treatment methods for accidental exposures to phosgene was completed at Johns Hopkins University The research shows several promising leads. The Panel, therefore, approved con tinuation of the research for another year. In addition, the Panel continued exploring feasibility of a program for evaluating dif ferent means of controlling phosgene re leases. Enhancing the ability to model a phosgene release is a complementary goal. The Panel also submitted comments to EPA on the Phosgene Health Assessment Document. In April, members of the Pan el's Regulatory Task Group briefed staff of the EPA Office of Air Quality, Planning and Standards at an information exchange meet ing. The CMQP5 is quickly gathering informa tion in preparation for proposing a hazardous air pollutant regulation in the near future. The Program was formed to improve in dustry's ability to safely manufacture, handle and use phosgene. Predicting and controlling ambient concentrations of phosgene from ac cidental releases has become an important Rand objective. The Find wifi continue information ex change and cooperation with OAQPS. In aidtion, the Panel wifi dosdy monitor other in creasing regulatory interest in phosgene Besides continuing research on exposure treatments, the Panel also plans to devel op a phosgene mitigation data base and a field testing program to assess mitigation devices. 12 CMA 030529 PHOSPHORUS (Closed Program) Chairman: W Carpenter Monsanto Company Date Chartered: 1985 Current Task Groups: None Program Manager: R. Romano Cham man The Program, which terminated in Feb ruary. was organized to advise the Depart ment of State during development of a I S. position on the international treaty to control chemical warfare agents. The Panel focused on the potential impact of treaty provisions on the production, distribution in commerce, and use of phosphorus com pounds. In this capacity, the ftnei held briefings for DOS and Department of Defense personnel and sent representatives to international meetings. Early in 1987. the list of substances af fected by the treaty expanded to include over fifty different chemicals, many of which were not phosphorus-based. The program was therefore dosed and the ad visory function transferred to the Chemical Warfare Disarmament Work Group of CMA's Health and Safety Committee. The Work Group continues to provide DOS with advice for industry on potential ef fects of various controls and requirements for inspection and reporting. PHTHALATE ESTERS Chairman: D Finney Eastman Chemical Company Date Chartered: m Current Taak Cinijai Toxicology Research Environmental Research industrial Relations Uaison Food and Drug Applications FDA Toxicology Research Program Manager: E. Moran The Panel worked with EPA in evaluat ing the health effects testing program that was completed as pan of a Negotiated Testing Agreement under TSCA Section 4. As part of this effort, the Panel sponsored a two-day symposium m Washington on the mechanism of action and species differ ences in the carcinogenic response of phthalate esters and related compounds. The objective was to put into perspective for FDA. EPA and CPSC, the relevance of rodent bioassay results to man. The pro ceedings of the symposium. "Recent Ad vances in Phthalate Esters Research." were published in the Journal of Toxicology and Industrial Health. The Panel submitted comments on the inclusion of three phthalate esters on the Acute Hazards List of SARA Title HI. Sec tion 502. Emergency Planning and Com munity Right-to-Know. As a result, EPA proposed to remove the phthalate esters from the list. The Panel also filed com ments with the NTP requesting removal of di-2-ethyihexyl phthalate from the Fifth Annual List of Carcinogens. Removal would be based upon the likelihood that di-2ethyihexyi phthalate. although a rodent carcinogen, is not a carcinogen in man. NTP has not announced a decision. The Program was formed to address environmental issues. In 1976, the alkyl phthalate category was placed on the first rrc list for test rale development under TSCA Section 4. Following the release of results on an NTP bioassay on DEHP and di-2-ethylhexyi adipate. EPA included health effects testing in its concerns. In 1980-81, the Panel worked with ERA to de velop the first Negotiated Testing Agree ment in lieu of a TSCA Section 4 test rale. The environmental portion of the testing was completed in 1984 and the results were submitted to the Agency along with a proposal for further environmental testing. Unfortunately, the decision in a lawsuit made it impossible for EPA to act on the Panel's proposal. In 1981. FDA became interested in the indirect food additive uses of DEHA and DEHP. in light of the NTP data. In 1985, FDA became concerned about the levels of DEHP reported in some foods. This year, 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 in the range of laboratory control samples. The Panel also designed and now is conducting studies on the pharmacokinetics and liver effects of di-2-ethylhexyt adipate. This program arose from FDA questions on a DEHA bioassay. DEHA continues as an in direct food additive while the Panel con ducts research. in January. EPA expressed an interest m discussing additional environmental testing on phthalate esters. The Panel currently is planning a program that will indude embryolarval and adsorption/desorption studies on nine chemicals. A consent agreement s ex pected to be signed with EPA in late 198". In addition to this testing the Rand will work dosdy with EPA in developing the next phase of the health effects testing program. in other regulatory activities, implementa tion of SARA. Cafifomias Proposition 65. and the Office of Solid Waste rule under RCRA will all require Panel positions, comments to agencies and further cooperation with other Special Programs and CMA Committees. POIYCHLORINAIED BIPHENYLS E. Gormiey The Pand continued addressing PCB dis posal and storage requuemaits as part of the Consensus Group which indudes the Environ mental Defense Fluid. Natural Resources Defense CoundL Edison Bectnc institute. Na tional Electrical Manufacturers Association and the Hazardous waste Iteatment Council. Con gress and ERA bebeve that the requirements belong under the RCRA The Consensus Group, however, stressed that the necessary storage and disposal controls can best be moMpreated into TSCA with all other PCB regulations. The Consensus Group sees se vere complications in movement of PCB controls into RCRA hazardous waste rales. in April, the Consensus Group success fully persuaded ERA to issue a policy for cleanup of accidental PCB spills. The EPA policy provides guidance on cleanup in a variety of settings. The Group onginally submitted a spill deanup proposal to the Agency in May 1985. The Pand now is as- CMA 030530 13 sessing the polio' and considering addi tional comments. The Program was formed to represent the interests of the industry during imple mentation of the "RCA Section 6 regula tions for control of PCBs. The Panel thus far has addressed inadvertent generauon of PCBs. mitigation of transformer fires and retenuon of electrical equipment con taining PCBs. as well as disposal and stor age requirements and cleanup of acciden tal spills. The Panel plans to continue focusing on PCB waste disposal issues and monitoring the spill cleanup policy. Tracking and commenung on the 1ARC review of PCBs, the implications of California Proposition 65. and the listing of PCBs for action under SARA are also planned priorities. RUBBER ADDITIVES Chairman: B. Hill Monsanto Company Date Chartered: 1979 Current Task Groups: Toxicology Research Program Miiufcr K. Rosica OMfcnan The Panel reviewed the draft results of NTP-sponsored chronic studies on 2-mercaptobenzothiazoie. Written and oral com ments wae presented to NTP's Science Advi sory Board in March. The Panel currently is considering further efforts to darify the in conclusive finding of the reports. A Panelsponsored voluntary pharmacokinetics testing program on MBT and its disulfide is near completion. The results will be submitted to EPA The data indicate that the two chemicals are very similar in toms of absorption, distri bution. metabolism and excretion. The Panel formed to support research that would expand the robber additives data base on safety and health issues. To date, the ftnei has collected information on approximately 65 chemicals that are classified as robber ad ditives. and has sponsored over 850,000 in research. The Panel will collaborate with the Ger man consortium. Will in continuing efforts to monitor, review and sponsor heath aid safety studies on robber additives. The two groups will cosponsor health studies in the coming year. The Panel also will respond to a TSCa Section h final test role on MBT which is expected by the end of 1987. TITANIUM DIOXIDE Oll^imar J. Blacker SCM Corporation Due Chartered-- 19" Current Task Group* None Program Manager H. Shah Chairman The Panel continued monitoring the Du font epidemiology study on titanium dioxide and titanium tetrachloride. The final report is expected by September 1988. Based on a preliminary analysis of data, it appears that titanium dioxide and titanium tetrachloride do not pose significant adverse health risks for wrtes. The Panel was formed to address concerns about potential hazards to workers in the complex atmosphere generated during formu lation operations with titanium dioxide. The fond plans to comment on ERAs proposed role to add titanium dioxide to the list of substances identified in the Preliminary Assessment information Rule. The Rule would require manufacturers and importers to sub mit production volume, end use. and expo sure data to EPA for risk assessment In the comments, the fond will maintain that ERA already has appropriate information for risk assessment and thus it is unnecessary to in dude titanium dioxide in the Rule. The member companies plan to file peti tions for delisting titanium dioxide from the SARA Title 111 Toxic Qiemicals List. The Pand also will trade state regulations that have added or plan to add titanium dioxide to their toxic chamcab lists. In a oomptementary effort, the fond will continue to work with the National Cancer Institute on its pro posal for an epidemiology study at other tita nium dioxide plana. The fond wifi step up efforts, based on epidemiology study results, to prevent fartha listings and petition for ddisting where necessary. TOLUENEDIAMINES Chairman: Vacant Date Chartered: mo Current Task Grou/sToxicology Survey Program Manager: C. Stack The Pand continues to monitor activities within EPA and OSHA on toluenediamines. There has been little ac tion within dther Agency over the past year. Through the Panel. TDA manufactur ers received a Chemical Advisory issued by the EPA Chemical Control Branch. Manu facturers. in turn, complied with the Agen cy's request to distribute copies to their customers. Although EPA is cooperating informally with OSHA under TSCA Section 9 on work place exposure control. OSHA has not made known its intent in this matter. The Pand awaits the Agency's decision. The Propin was formed in 1982 to ad dress aspects of an Advance Notice of Pro posed Rulemaking issued by ERA on phenylenediamines. The Pand subsequently sub mitted comments to the Agency on sec tions of the ANPR related to toluenedia mines. Since that time, the Pand has re mained alert to ERA'S concerns and data requirements, and has supplied informa tion as needed. TRIMELUTATE ESTERS Chairman: D. Finney Eastman Chemical Company Dmac Chartered: mi Current Taak Otoupa: Toxicology Research E. Moran The fond completed the final study on tri-2-ethyihexyi trimdlitate that was pan of a negotiated testing agreement under TSCA Sec tion i. The study compared the short-term CMA 030531 liver effects of the trimellitate with the ef fects of two related chemicals -- di-2eihvihexyi phthalate and 2-ethylhexanol. Results were submitted to EPA in May. The ITC designated the trimellitate for priority testing under TSCA Section 4 in 1982 and recommended metabolism, sub chronic. mutagenicity and environmental effects testing. The producers immediately formed a special task group under the Phthalate Esters Panel, and then subse quently formed the Program to pursue a negotiated testing agreement. The testing agreement was reached with EPA in 1984. When EPA reviews the test data, the Panel will work with Agency scientists to aid in interpretation and in determination of any additional data needs. The Panel now awaits an EPA response. VINYL CHLORIDE ChMirmjui; VI Gaffey Monsanto Company One Chartered: I9'3 Current Taak Group* Research Coordinator Program Manager: H. Shah Oiatmmn The final report of the Panel-sponsored epidemiologic study of vinyl chloride work ers from 1942 to 1982 was completed and sent to pertinent government agencies in October. The study showed an excess in mortality from causes not previously associ ated with vinyl chloride -- non-angjosarooma and biliary tract tumors. It is uncertain whether the excess really was due to otha types of tumors or to angiosarcomas that were misdiagnosed as other liver and biliary cancers. The Panel was formed to support activi ties related to the accumulation and as sessment of health and safety data on vi nyl chloride monomer. After binding sever al animal studies, emphasis on research shifted from toxicological investigations to the early diagnosis and dimcal management of vinyl chloride-related miuries. In the mid1970s the emphasis further shifted to epidemiologic studies on vinyl chloride workers. The Panel currently is exploring the possibility of conducting a pathology re view of available tissue specimens and slides to clarify the epidemiologic findings. VINYLIDENE CHLORIDE Z. Bell PPG Industries. Inc. Date Chartered: 1974 Current Taak Group*: Toxicology Research Program Manager: R. Romano In August. EPA proposed a TSCA Section 4 test rule on VDC requiring a two-year bioassay. The Panel provided comments on the proposed rule focusing on the lack of finding needed by the Agency to require testing of this chemical under Section 4. Because the EPA Office of Air Quality Planning and Standards referred VDC to the Test Rule Development Branch, the Panel also concentrated on persuading this Office to withdraw its request. The Program was formed to sponsor in vestigations of the potential toxicologic ef fects and pharmacokinetics of VDC. Over the years, the Panel has also tracked sig nificant research projects that can help de fine potential health and environmental ef fects of VDC. The Panel will continue to meet with TRDB and OAQPS in efforts to educate both groups and convince them that an additional bioassay on VDC is unnecessary. water additives Chiimufl.* J Gallagher American Cyarumid Company Date Chartered; 1985 Current Taak Group*.None Program Manager: R. Romano mr* s CUnn The Panel held several discussions with the National Sanitation Foundation, the or ganization that received an EPA grant to establish a program for setting direct and indirect water additive standards. The Panel has numerous concerns with the NSF pro posed program. As a result the Panel has sought alternative programs. It appears that the American Wuer Works Association will develop a viable program of standards-setting that die Panel feds comfortable in support- 8The Program was formed to address regu lations of direct and indirect potable water additives. Die objectives are to monitor regu latory poboes. improve communication. re view available toxicology data, develop advo cacy positions, ensure that any wtuer additive program is designed and administered m a cost-effective manner, and ensure that water additives are used in a manner that does not compromise public health, safety, and the en vironment. Die Panel will continue to work with all organizations that are developing water addi tive standards programs in our attempt to find the best one. The Panel soon will partici pate in the annual AWWA meeting where this organization s standards program will be fur ther discussed and defined. 15 CMA 030532 TABLE 1 FINANCIAL STATUS For the Twelve Months Faded May 31, 1987 Program Balance June 1,1966 Contribution Receipts Interest Revenue Ejtpendlrures Baianer May 41,19*' 41kanolamines Aromatic Diamines Arsenic Benzene Biocides Butadiene Burylated Hvdroxvtoluene Chlorobenzenes Cresols Cumene Cyclohexane Dibenzofurans/Dibenzodioxins Epoxy Resins Ethylene Dibromide Ethviene Dichloride Ethylene Glvcol Ethylene Oxide Ethyihexanol Ethvlhexanoic Acid Fluorocarbons Glycol Ethers Hvdroquinone/Quinone Isopropanol Ketones Lubricant Additives Metal Catalysts Methvlenedianiline Naphthenates Octylphenol Olevlamine Phosgene Phosphorus Phthalate Esters Polychlorinated Biphenyls Rubber Additives Titanium Dioxide Toluenediamines Trimellitate Esters Vinyl Chloride Vinvlidene Chloride Water Additives Totals S 67.400 -0- 60.100 604,900 15,700 121,700 14,400 104.300 (14,200) 126.100 9.500 (8.400) 4,000 400 22.000 -0- 86,300 0- (19.600) 3.351,000 349,900 12,600 *0" 155,400 25.700 45.400 76,400 6,900 25,200 13.700 134.000 6.700 949.400 10.900 127.400 3.900 23.800 14.300 93.400 37.400 7,200 S6.665.200 S -010.000 9.000 0* 258.100 159,900 48.000 636,300 73,600 21,900 96,300 100,000 -0-0-0- 187,700 297,100 122,400 334,300 1.986.600 309.600 10.000 21.000 68,000 74,000 97,500 167,300 -0-012.500 151,700 1.800 337,700 60.000 92,300 20.000 -0* -0-0-055.500 S5.8I7.100 s 3,900 -0- 2.000 33.300 1.200 5.600 600 7,400 2,300 6,700 1.400 1.100 100 -0- 1.100 1.400 7.500 600 1.400 178,900 21.100 300 100 10.100 900 2.200 500 300 600 900 7,600 100 57.900 1.000 7.100 100 1.300 800 4.100 1.300 (200) S 374.200 S 2.700 2.100 46.900 66,300 170.800 164,300 35.600 379.700 60.800 80.000 55.200 38.400 1.500 300 9.300 46.700 156.100 70.000 115.800 2.263.400 212.300 28,900 14.100 96.200 79.300 74.200 263.100 3.200 26.300 11.900 167.200 8.600 303.100 56.000 89.000 8.600 2.200 7,800 45.400 45.200 52JOO 15,361,000 - S 68.700 '.900 24.200 571,600 104.200 119.900 2",400 368.700 900 74.700 52.000 54.300 2.600 100 13.700 142.400 234.800 52.200 200.300 3.253,100 468.300 (6.000) '.000 13'.300 21,300 70,900 (18,900) 4,000 (500) 15.200 126.100 *01.041.900 15.900 137,800 15.400 22,900 7.300 52.100 (6,500) 10.400 $7,495,500 6 CMA 030533 FINANCIAL RESOURCES U lac/] program is requked to maintain a CASH COMPENSATING BALANCE which recognizes that CMA signs all contracts on behalf of the panels and assumes the financial liability for panels meeting them contractual commitments. The balance permits timely honoring of financial com mitments. The combined compensating balance for all Speciid Programs at the beginning of Fiscal Year 86-87 was nearly $6.7 million. Compensating balances on May 31,1987 totalled approximately $7.5 million. On this date, CMA had financial liabilities totalling about $7.4 million under 195 exe cuted contracts on behalf of the various panels. INTEREST on the unexpended cash balance provides supplemental revenue for each Special Pro gram. This year, programs earned a combined total of approximately $374 thousand in interest in come. EXPENDITURES of Special Programs are based on budgets approved by each panel. In Fiscal Year 86-87, programs spent a collective total of $5.4 million for research, consultants, legal counsel and program management. Figure 1 SPECIAL PROGRAMS FINANCIAL ALLOCATIONS CMA 030534 17 Figure 2 SPECIAL PROGRAMS SUBMISSIONS TO GOVERNMENT AGENCIES Figure 3 SPECIAL PROGRAMS STATUS OF CHEMICALS UNDER TSCA SECTION 4 IMENTTO DESIGNATE DCKAUH) Cvrtohccw Ftithehne Esm PtOTOSED (LIE Butyl Hcniyt PlMhuttie FINAL &1E DiethvleneGivcoi Butyl Ether 2-Ethvlhennol Mcnaptotaro ihismie CreMb 2-EdiyllMamtt Aad MejhyKWde Tntthytene Glycol Etben VinvBdmt ailondf DibraoLwim. TET1NG COMPLETED Methyl Ethyl Ketone Methvl bobotyl Ketone Onylphend TNt-2-Ethyihejyt Plwhebte Ejien CMA 030535 REGULATORY AFFAIRS n all, 35 Special Programs worked directly on regulatory issues this year. J Panels, as usual, submitted comments on pending regulations and research data to a wide variety of federal, state and international agencies. Foremost in attention among federal agencies was EPA. TSCA Section 4 testing is a major emphasis of 24 panels (Figure 3). Environmental regulations that caused increased efforts were the Clean Air Act, Safe Drinking Water Act, and RCRA. In an emerging interest, panels increasingly addressed FIFRA concerns. During the year, other federal agencies that panels cooperated with were the Food and Drug Administration, Occupational Safety and Health Administration, National Toxicology Program, and the National Cancer Institute. Among state agencies, the California Department of Food and Agriculture commanded the most at tention because of Proposition 65 implementation and data call-ins on industrial chemicals. In the international area, the United Nations Environment Programme, U.S. Department of State, Internation al Maritime Organization, and the Food and Agriculture Oiganization/Wodd Health Organization were principal focuses. Figure 4 SPECIAL PROGRAMS STAFF TIME ALLOCATION NTP 3% DOS / 2% / State Agencies 2% ADVOCACY 19 CMA 030536 Tlie hunching of the ozonesonde at McMurdo Station (picture) is one example of panel-sponsored research. The Fluorocarbon Program Panel co-sponsored atmospheric measurements In the 1986 Ant arctic Ozone Campaigns with NASA, NOAA, NSE the British Antarctic Survey, and the Lauder Group. Fluorocarbon Program research funds also are used to sponsor chemical kinetics studies, atmospheric and climate modeling, biologi cal effects monitoring, and oth er studies related to the atmos pheric fate of chloroOuorocarbons. 20 CHA 030537 RESEARCH hirty-three Special Programs sponsored some form of research. The trend this year was to Tward fewer; but larger, projects. Health effects studies were a major focus. Toxicological research involved subchronic/ chronic, mutagenicity, teratogenicity, oncogenicity and pharmacokinetics studies. Direct effects on hu mans were investigated by several programs through epidemiology and clinical research. Risk assess ments and exposure surveys were other forms of research undertaken by nearly a quarter of all Spe cial Programs. Environmental studies, including the atmospheric sciences, increased this year, reflect ing greater interest in air and water regulations, in particular. Testing required under TSCA Section 4 was initiated by several Special Programs. Mainly, the tests are large-scale efforts lasting several years. The testing schemes include many decision points where EPA and industry scientists must interpret data and decide on next steps. As in the past, some panels undertook studies simply because of research findings rather than di rect regulatory concerns. "Proactive" research of this kind continues to be a significant part of Spe cial Programs scientiBc efforts. Figure 5 SPECIAL PROGRAMS SUMMARY OF CONTRACTS MANAGED FOR THE SPECIAL PROGRAMS YEAR CMA 030538 21 GUIDANCE he Special Programs Policy Committee ensures that all Special Programs are conducted in a man Tner consistent with Association Policy, and with the Special Programs Guidelines; counsels nith Special Programs regarding new and revised operating needs; and, reviews and makes recommen dations on all advocacy programs on individual chemicals requested by a program panel or staff. SPECIAL PROGRAMS POLICY COMMITTEE MEMBERS Langley A. Spurlock Staff Executive CMA Chairman: Hany Corless ICl Amencas Inc. Figure 6 Vice Keith R. McKinnon The Dow Chemical Company Geraldine V. Cox Vice Presdent- Techmcal Director CMA Gary C. Henman David F. Zoil Nice Preadent-fteasurer Vice Prwtdent- CMA General Coumnsel CMA For l98~-88: ChMirmsn: Edwin L. Scenzet BASF Corporation Vice Chairman: Earnest W. Deavenport. Jr. Eastman kodak Company SUMMARIES OF PRINCIPAL GUIDANCE STATEMENTS FOR THE SPECIAL PROGRAMS SPECIAL PROGRAMS OPERATING PRINCIPLES The Principles present the general statement of policies and procedures for operation of all Special Programs. They address: * Participant Financial Obligations Policy Coordination Research Output SPECIAL PROGRAMS 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 opera tions of special programs and the Special Programs Division. Topics covered include: Program Initiation Procedures Membership Criteria Responsibilities of Panel and Task Group Participants Financial Administration and Budgeting Contracting Procedures 22 CMA 03053? DIVISION STAFF he Division staff managed more Special Programs during 1986-87 than ever before. The full Tstaff complement of seventeen persons did not increase during the year. The managing staff underwent no changes torn the previous year. DIRECTOR Langley A. Spurlock, Ph.D. Dr. Spurlock marked his fifth year as Director of the Biomedical and Environmental Special Programs Di vision. He is responsible for over sight of all Special Programs. Before joining CMA, Dr. Spurlock held an appointment in the U.S. Government Senior Executive Servce at the National Science Founda tion. During his tenure at NSF he served as Senior Staff Associate for Operations, Directorate for Mathe matical and Physical Sciences, Spe cial Assistant to the Director, Office of Planning and Resources Manage ment, and as Oversight Coordinator and Special Assistant to the Direc tor, Office of Audit and Overnight. Previously, Dr. Spurlock received an appointment as U.S. Department of Health, Education and Welfare Fel low, and served as Special Assistant in the Immediate Office of the Sec retary of HEW. Earlier, he was As sistant to the President at the American Council on Education. Be fore coming to Washington, Dr. Spurlock held an appointment as Associate Professor of Chemistry at Brown University and earlier was Assistant Professor of Chemistry at Temple University. Previously, he served as Senior Research Chemist in the General Chemical and Agri cultural Chemical Divisions of Al lied Corporation. Dr. Spurlock re ceived a Ph.D. in Organic Chemis try from Wayne State University, ASSOCIATE DIRECTORS Robert R. Romano, Ph.D. Dr. Romano joined CMA in 1980 as a manager in the Environmental Division where he was responsible for the water and air programs. In February 1985, he joined the Spe cial Programs Division as an Associ ate Director. He continued this year as manager of the programs on bu tadiene, ethylene dibromide, ethyl ene dichloride, ethylene oxide, phosgene, water additives, and vinyiidene chloride. Recently he also assumed management of the pro gram on chlorine dioxide. Dr. Romano came to CMA from the U.S. Nuclear Regulatory Com mission, where he worked as an As sociate Project Director. Previously, he worked on a school fluoridation project for Indiana Sate Board of Health. He has also aught at Del Mar College and American Universi ty. Presently, Dr. Romano is an ad junct Environmental Engineering Professor at George Washington University and teaches a course in environmental management. He re ceived a Ph.D. in Environmental Sciences from Purdue University. Carol R. Stack, Ph.D. Dr. Stack joined CMA and the Special Programs Division in 1980 and was promoted to Associate Di rector in 1985. She is currently re sponsible for management of the programs on ethylene glycol, glycol ethers, benzene, chlorobenzenes, ketones, lubricant additives, dibenzofurans/dibenzodioxins and toluenediamines. Before joining CMA, Dr. Stack was employed in the Toxicology and Biomedical Science Department at Equitable Environmental Health, where she served as an Assistant Project Director responsible for the preparation of NI05H multi-chemi cal criteria documents. Earlier, she served as Visiting Scientist at the Neurological institute of Bogota, Colombia, where she investigated central auditory pathways in echolocating birds. Dr. Sack received, a Ph.D. in Biology from New York University. PROGRAM MANAGERS Elizabeth Festa Gormley, BA. Ms. Fesu Gormley joined CMA and the Special Programs Division in 1983. She is responsible for the management of the fluorocarbons and polychlorinated biphenyls pro grams. Prior to joining CMA, she was Section Stan Executive with the Na tional Electrical Manufacturers Asso* CMA 030540 _ 23 ciation, where she was responsible for the Nuclear Magnetic Resonance Imaging Section with the Diagnostic Imaging and Therapy Systems Divi sion. Previously, Ms. Festa Gormley worked in the Endocrine Biochem istry section of the National Insti tute of Arthritis and Metabolic Dis ease 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 recipi ent of a National Science Founda tion Assistantship. Ms. Festa Gormley earned a BA in Chemistry horn Albertus Magnus College. Elizabeth J. Moran, Ph.D., DA.B.T. Dr. Moran joined CMA and the Special Programs Division in 1981. She continued this year as manager of the programs on phthalate esters, trimeilitate esters and methylenedianiline and assumed management of two new programs on 2-ethylhexanoic acid and spe cialty acrylates and methacrylates. Dr. Moran is a biochemist and Board Certified toxicologist. She is currently on the Editorial Board of the Journal of Toxicology and Envi ronmental 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 chemicals. Previously, Dr. Moran conducted lipid nutrition re search at the U.S. Department of Agriculture and was a visiting pro fessor at the University of Mary land. Dr. Moran received a Ph.D. in Biochemistry from the University of Maryland. Henry J. Sauer, MBA Mr. Sauer joined the Special Programs Division in May 1986. He had been Manager of the CMA En ergy and Engineering Section since 1984, and the Energy Committee Staff Executive since he joined CMA in 1977. At CMA he also served as Manager of the Solid Wastes Manage ment Committee; Manager of the En vironmental Management Committee Task Groups on New Source Perform ance Standards for Industrial Boilers and Process Emission Regulations; Manager of the Insurance Committee, and Manager of the Special Program on Benzene. He is responsible for management of the programs on cyclohexane, alkanolamines, hvdroquinone, ethyihexanoic acid, and oayiphenol. He is also actively in volved in management of the pro gram on fluorocarbons. Prior to joining CMA, Mr. Sauer had chemical industry experience in sales, marketing research, applications research and commercial develop ment. Just before joining CMA he was Development Manager, Fine Chemi cals Group, Great Lakes Chemical Corporation. Earlier, he was employed at PPG Industries as Mattering Re search Representative in the Industrial Chemical Division and the Coating; and Resins Division, and as Assistant to the Sales Manager and Technical Sales Representative. He previously served as First Lieutenant in the US. Army Corps of Engineers. Mr. Sauer holds an MBA from the University of Pittsburgh, and a BS. in Giemical Engineering from Carnegie Mellon University. Hasmukh C Shah, Ph.D., DA.B.T. Dr. Shah joined CMA and the Spe cial Programs Division in 1979. He is responsible for management of the programs on arsenic, biocides, butyteted hydroxytoiuene, metal cata lysts, titanium dioxide, vinyi chlo ride, oleylamine, and naphthenate metal soaps. Dr. Shah is a Board Certified toxi cologist. 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 National Institute for Occupational Safety and Health s criteria document project, and for the "Profiles on Oc cupational Hazards for Criteria Docu ment Priorities." Earlier, at the Stan ford Research 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 Sciences. Dr. Shah received a Phi), in Pharmacology and Toxicology from the University of Rhode Island. MANAGER Kathryn A. Rosica, B.S. Ms. Rosica joined CMA and the Special Programs Division staff in 1986. She is responsible for man agement of the programs on cresois, isopropanol, cumene, aromatic dia mines, and robber additives. She is also actively involved in management of the programs on phthalate esters and hvdroquinone. Before coming to CMA Ms. Rosica was a staff toxicologist for the Region I Supeifund Division of the NIIS Cor poration, where she prepared risk as sessments of hazardous waste sites in New England. Previously, she was em ployed as a toxicologist at General Electric Company, IQ Americas Inc. and S1SA Pharmaceuticals, Inc. Ms. Rosica holds a BB. in Toxicology from Northeastern University. 24 CMA 030541 DIVISION MANAGERS CMA 030542 Z5