Document M4GkDgjzpLNYRKrXevMD4vxvM

<! frfffl! - **> : : j jin hi: i l : i ;' il ! : ! ; Ii -ft ! : i <t iwwui 1CHEMSTAR 'zz titutii uif iiim Min in mmu m imuci PANEL AND COUNCIL DETAILS * A REPORT ON THE YEAR 1993-1994 iar*tmm .3.- f//v ;r1A 030849 The CHEMSTAR Vision "To be the most effective provider of technical and management services for specific issue groups within the chemical industry. To have our groups be the best in the world at addressing advocacy, research, education, communication, and evaluation issues in their focus areas." 1CHEMSTAR Panel and Council Details Panel/Council Page Panel/Council Page Acetone....................................................................................... 2 Alkanolamines........................................................................... 2 Alkvlphenols and Ethoxylates................................................ 2 American Plastics......................................................................3 Aryl Phosphates.................................................... Atmospheric Research.............................................................4 Biocides...................................................................................... 5 Brominated Flame Retardants................................................. 6 Butadiene....................................................................................7 Butylated Hydroxytoluene.......................................................8 Carbon Disulfide.......................................................................8 Carrier Assessment....................................................................8 Chemical Distributors.............................................................. 9 Chlorinated Pool Chemicals................................................... 9 Chlorine Chemistry.................................................................. 9 Chlorine Dioxide................................................................... 10 Chlorobenzenes..................................................................... 11 Cobalt..................................................................................... 11 Cresols.................................................................................... U Crystalline Silica................................................................... 11 Cumene................................................................................... 12 Cyclohexane.............................................................................13 Dibenzofurans/Dibenzodioxins........................................... 13 Diisocyanates......................................................................... 14 Dinitrotoluenes...................................................................... 14 Ethylenebis(stearamide)....................................................... 15 Ethylene Dichloride [Completed]......................................... 15 Ethylene Glycol..................................................................... 15 Ethylene Glycol Ethers........................................................ 15 Ethylene Oxide...................................................................... 16 Fluoroalkenes......................................................................... 17 Hexamethylene Diisocyanate.................................................17 Hydrazine............................................................................... 17 Hydrogen Fluoride................................................................ 18 Hydroquinone........................................................ t............. 18 Inorganic Acid Mists............................................................. 18 Isopropanol............................................................................. 19 Ketone4s................................................................................... 19 Laboratory and Research Chemicals................................... 20 Maleic Anhydride....................................................................20 Metal Catalysts........................................................................20 Methyl Bromide Industry.......................................................21 Nitrosamines (Completed].....................................................21 Olefins...................................................................................... 21 a-Olefins..................................................................................22 Oleylamine.............................................................................. 22 Oxo Process............................................................................. 23 Petroleum Additives............................................................... 24 Phenol....................................................................................... 25 Phosgene...................................................................................26 Phthalate Esters.......................................................................26 Polychlorinated Biphenyls.....................................................27 Propylene Glycol Ethers........................................................27 Propylene Oxide......................................................................28 Rubber Additives.....................................................................28 Sodium Bromide.....................................................................28 Specialty Acrylates/Methacrylates....................................... 29 Terephthalates.......................................................................... 29 Titanium Dioxide....................................................................29 Toluenediamines...................................................................... 30 Total Quality............................................................................ 30 Tris(chloroalkyl)phosphates...................................................30 Vinyl Chloride......................................................................... 31 Vinylidene Chloride............................................................... 32 Water Additives....................................................................... 32 CMA 030SS1 CHEMS1M A Report on the rear 1993-199A Acetone Panel HISTORY The Acetone Task Group formed under the Ketones Panel in 1990 to address regulatory concerns of manufacturers, processors, and users. Task Group mem bers decided to form a separate Panel because of the com plexity and diversity of acetone issues. ACCOMPLISHMENTS: By submitting information on toxicity and environmental concentrations, the Acetone Panel successfully advocated the removal of acetone from the Arizona Department of Environmental Quality's pro posed list of hazardous air pollutants. After the Panel presentation at an ACGIH Committee Meeting in March 1993. and at the specific request of ACGIH members, the Panel developed a review of available human data on acetone. The Panel report, "The Local and Systemic Health Effects of Acetone," was provided to ACGIH Com mittee members for consideration in the acetone thresh old limit value review. The Acetone Panel also submitted a petition requesting EPA to reclassify acetone as a vola tile organic compound of negligible reactivity. In con junction with that petition, the Panel provided EPA with acetone reactivity data developed by Dr. William Carter of the University of California at Riverside. Throughout the year, the group continued its communication with the EPA IRIS Work Group on establishing a reference dose for acetone, and with the National Sanitation Foundation on its accreditation of acetone as a potable water solvent. PLANS: The Panel will proceed with the scheduled-controlled operant behavior (SCOB) neurotoxicity testing pro gram, which was agreed upon during the settlement ne gotiations in January, and will be outlined in a final con sent order in the fall. In addition, the Acetone Panel will continue its communications with ACGIH regarding the acetone TLV review process. The Acetone Toxicology Research Task Group will develop a dossier for Phase 4 of the OECD SIDS program and address misinformation included in some publicly available databases. ACCOMPLISHMENTS: The Panel completed a num ber of studies on monoethanolamine and diethanolamine under its voluntary research program. Completed research includes an in vitro dermal absorption study and studies on developmental toxicity in both rats and rabbits. Vol untary research in progress includes a pharmacokinetic study of DEA. The Panel initiated a literature review covering the use, chemical and physical properties, toxicology, and phar macokinetics of alkanolamines. Once completed, the lit erature review will be published. Efforts also were initi ated by the Panel to publish results of its voluntary re search program. In 1993, EPA issued a proposed rule that would establish an RQ of 100 pounds for DEA. The Panel submitted com ments to EPA indicating that the Agency incorrectly cal culated the RQ, and that available scientific data support an RQ of 5,000 pounds. The Panel expects a response from EPA on the RQ issue in late 1994. PLANS: The Panel plans to: continue voluntary research activities; submit completed research studies to the Na tional Toxicology Program; publish research results in various peer-reviewed journals; publish a literature re view of alkanolamines; develop a scientific position state ment on the health effects of alkanolamines; continue ad vocating an increase in the RQ of DEA; and, monitor and respond to new regulatory developments. Alkylphenols and Ethoxylates Panel HISTORY: 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 about the chemical fate and environmental effects of nonyiphenol. The Panel main tains liaison with the Soap and Detergent Association on scientific and regulatory issues. Alkanolamines Panel HISTORY: The Panel formed to address toxicology is sues associated with alkanolamines. Current Panel ef forts are focused on voluntary research, publishing data, and regulatory advocacy. ACCOMPLISHMENTS: The Panel completed all test ing under TSCA Section 4 for nonyiphenol. In April, the Panel participated in an OECD-sponsored Risk Reduc tion Workshop hosted by the Swedish EPA. The Panel held a facilitated planning session in which communica tion and research needs were identified as further priori- A Rep An CHA 030852 A Report on the Year 1993-1994 CHEMSTM ties. The Panel continued to work with the state of North Carolina and the Wisconsin Department of National Re sources on alkylphenols and ethoxylates on water treatability issues. PLWS: The Panel will continue to educate the l:.S. regu latory community on the results of Panel research. A risk assessment of APEs will be performed by the Panel by late 1994 The Panel also will continue to work with the Swedish EPA and agencies of other European countries. Biodegradation and treatability studies will be investigated by the Panel to assist North Carolina and other states in assessing potential risks of these chemicals to the envi ronment. The Panel will continue to identify research and communication needs. In addition, the Panel has developed an information package on APE. American Plastics Council HISTORY: The Council formed in 1991 to develop tech nically and economically sound programs for the respon sible use. recovery and conservation of plastics and their component raw materials that address public interests and concerns, and to communicate the benefits of plastics and their use to key publics. GOALS: To assure that plastics are the preferred materi als by actively demonstrating they are the responsible choice in a more environmentally conscious world. The strategic elements to fulfill this mission include: informing opinion leaders and the public about plas tics' advantages in resource conservation and the progress the industry continues to make; developing programs and alliances to implement this strategy; and, supporting integrated approaches to waste manage ment: supporting increased plastics recycling that is economically and environmentally responsible and sustainable; developing meaningful measures of environmen tal performance, including better methodologies for determining recycling rates; and, working to ensure the energy value of plastics is captured where practical. STRUCTURE: The APC operates as a joint initiative with The Society of the Plastics Industry. Inc., and its purpose is to encourage efficient resource management throughout the life-cycle of plastics products. To meet these goals. 24 of the nation's leading plastics resin mono mer producers and representatives of the broader plastics processor community have come together with direct in volvement by chief executive officers, president and se nior executives. Council members have made a substan tial commitment and pledged significant resources to achieve this goal. These top executive have joined forces in this effort be cause industry believes it has the responsibility not only to respond to public needs with its products but also to respond to public values through its actions. The APC has an integrated organization, directed by the APC Board of Directors and implemented by ten func tional committees in Federal Government Affairs, State Government Affairs, Advertising, Communications, Pack aging, Durables, Product Benefits, Process Technology. Business Impact/Information Management and Plastics Mobilization, as well as two ad hoc task forces, West Coast and Energy Recovery. The technical committees' (Packaging, Durables, Prod uct Benefits. Process Technology, Business Impact/Infor mation Management) functions are to research and de velop economically sound integrated resource manage ment technologies and implement these solutions in a timely manner. Some of those efforts include: continu ing to develop technology to determine the optimum level for mechanical recycling of plastics; furthering the de velopment of advanced recycling technology systems; conducting life-cycle analyses of plastic products; and compiling and/or developing energy recovery data. The Advertising and Communications Committees dia logue with and communicate to the public, policy mak ers, educators and other target audiences to convey the resource management benefits that demonstrate plastics' positive role in society and the environment. This com munication will help build public support for industrysponsored solutions and position plastics as an efficient use of natural resources. CHCMSTM A Report an the Year 1993-1394 The Government Affairs Committees work with legisla tors and regulators to ensure an appropriate government role in providing responsible integrated resource man agement programs. The Federal and State Government Affairs Committees focus on local, state and federal gov ernment officials to broaden the current public policy debate to include effective solutions such as recycling, advanced recycling and energy recovery. The Plastics Mobilization Committee develops a core group of motivated downstream industry representatives committed to speak as a credible voice on critical resource management public policy issues. The Committee tar gets key local industry personnel with a concerned com munity viewpoint and focuses their efforts at the local, state and federal levels. Aryl Phosphates Panel HISTORY: Before coming to CMA, the manufacturers were part of an ad hoc committee which formed to re spond to inclusion of the chemical category in the Sec ond Report of the Interagency Testing Committee in 1978. When EPA announced its intention to initiate rulemaking underTSCA Section 4, the members disbanded the Com mittee and reformed as a CHEMSTAR Panel. ACCOMPLISHMENTS: In March 1993, EPA provided the Panel with a draft enforceable consent agreement for the aryl phosphate TSCA Section 4 test program. In many significant areas, the Agency's draft agreement coincided with the Panel's September 1992 proposed testing pro gram, which was submitted under EPA's open season ini tiative. PLANS: The Panel will initiate the consent order nego tiations with EPA soon. Additional Panel activities in clude sponsoring the negotiated testing program and re sponding to other regulatory concerns. Atmospheric Research Panel HISTORY: The Council formed to address issues con cerning the impact of chemical industry emissions on re gional and global atmospheric change. Activities include: identifying and resolving scientific uncertainties about ef fects of increased concentrations of chemicals in the at mosphere; obtaining research data that will assist in de veloping chemical industry positions on such issues as Clean Air Act implementation and global climate change, and. providing a scientific foundation for the industry's position in the debates on a global effort to control green house gases. ACCOMPLISHMENTS: The Council continued its re search program to increase understanding of the impact of chemical emissions and volatile products on global cli mate change. The Council decided to become a major co-funder of a project to develop an assessment model for the chemical industry. As part of this project, a work shop was held in Cambridge. Massachusetts on three-di mensional chemical transport assessment modeling in September. The Council also contributed funding for; an international workshop by NIST on chemical kinetics; a project by the International Global Atmospheric Chemis try for the development of global emissions inventories; and. a project to update estimations of hydroxyl radical reaction rate constants. PLANS: The Council will double its efforts to "work with the scientific community to develop a consensus re port by the end of 1996 to characterize the indirect ef fects on global change of short-lived atmospheric emis sions from the products and processes of the chemical industry." This effort will include refining estimates of direct Global Warming Potential as well as appropriate measures of indirect effects. The Science Task Group will continue to sponsor and monitor the 3-D modeling effort and the IGAC inventory of emissions that will help to evaluate the potential indirect effects of chemical indutstry emissions on climate change. Council members will continue to seek expanded mem bership and secure additional research funding, in prepa ration for addressing an issue that will remain on scien tific and regulatory agendas into the next century. The Council remains committed to the belief that it can have a significant impact at the most fundamental level of policy development through involvement with the scien tific community and through the generation and commu nication of scientific research. 9.4 A Repo t i t i CMA 030854 A ffeoorf on tha 'fiat 1993-1994 CHEMSTAH Biocides Panel HISTORY: The Panel was termed in 1986 to respond to the California Department of Food and Agriculture data call-in notices on biocidal chemicals registered in the state. The DCIs required that registrants submit data on chronic toxicity, oncogenicity, reproductive effects, teratogenic ity, mutagenicity, and neurotoxicity. The Panel since has focused on a variety of issues impacting the biocides in dustry as a w hole, and v anous task groups hav e addressed issues surrounding specific biocides. ACCOMPLISHMESTS: The Panel has developed a comprehensive educational program, along with support ing written materials, for presentation to pesticide regu latory personnel. The program was presented to the staff of EPA's Office of Pesticide Programs on two separate days in December. In April, the Panel presented the pro gram to the staff of CalEPA's Department of Pesticide Regulation, and in June to Canadian officials from Agri culture Canada. Health Canada, and Env ironment Canada. The presentations to the various regulatory personnel in cluded discussions of biocide application methods, uses, exposure patterns, effluent treatments and other issues of importance in the regulation of biocides. The Panel is optimistic that the information provided to EPA. CalEPA, and Canadian officials will enable each of these jurisdic tions to employ more appropriate data requirements and to arrive at more timely registration decisions for indus trial biocides. reregistration. EPA. in its efforts to meet both registra tion and reregistration deadlines, has been increasingly receptive to Panel suggestions. The Panel, in conjunc tion with other industry trade associations, and in response to an EPA request, has been working to develop revised procedures for implementing the data compensation provisions of FIFRA. Revisions are needed because regis trants that have spent large sums of money on data to obtain and support registrations often are unaware of follow-on registrants, and thereby have not obtained com pensation that may be due them for the follow-on registrant's reliance on their data. The Panel also has com mented on a number of regulatory proposals that impact pesticides, including the proposal to add 25 or more in dustrial biocides to the Toxics Release Inventory and pro posed regulations regarding pesticide containers and resi due removal. The Panel also is involved in activity to persuade OPP to either discontinue or substantially re vise its policy regarding water hazard evaluation and risk modeling for industrial biocides undergoing reregistra tion. EPA is drafting revisions to the regulations which govern pesticide registration data requirements under 40 C.F.R. Part 158. In an effort to influence this process and ensure that data requirements for industrial biocides are appro priate. the Panel has provided suggested industrial bio cide data requirements to EPA. Panel representatives w ill discuss the suggested requirements with EPA staff throughout the drafting period. In the legislative area, the Panel has joined with other industry trade associations to develop a legislative pro posal that distinguishes antimicrobials from other pesti cides and streamlines pesticide registration procedures. The proposed legislation is under consideration for intro duction as an amendment to FIFRA reauthorization leg islation in the current session of Congress. The Panel is also working with other trade associations to respond to EPA's request for statutory authority for additional fees to fund the pesticide reregistration process. Industry groups believe that EPA's request is inflated and plan to provide Congress with more realistic funding informa tion. In the regulatory area. Panel representatives have contin ued to meet with EPA officials to discuss ways to stream line the pesticide regulatory process for registration and D-S The Panel is continuing its monitoring of state regulatory and legislative activities that impact the biocides indus try. States continue to seek additional revenues through increased registration fees and other forms of revenue col lection, including assessments for groundwater cleanup based on pesticide sales. Many of these activities have imposed unreasonable burdens on biocides manufactur ers. In addition, a number of states have proposed legis lation that would require decreased use of pesticides by state agencies or mandate that many pesticides, includ ing industrial biocides, be applied only by certified ap plicators. The Panel has commented to a number of states where either the proposed legislation or regulations would impose inadvertent or unwarranted burdens on the bio cides industry or biocide users. The Panel currently is monitoring activities in 17 states and has targeted a num ber of states including Wisconsin, New York, and Penn sylvania for advocacy activities. CM A 03'" CHEMSTM A Report on the Year 1393- 1994 The Antimicrobial Exposure Assessment Task Force con tinues to be active in ensuring that follow-on registrants of industrial biocides for which reregistration was in part supported by the Antimicrobial Exposure Assessment Study proside adequate compensation to the Task Force for such reliance The Task Force is negotiating with one follow-on registrant and has requested information from EPA that will enable it to determine whether there are other registrants relying on Task Force data from which compensation offers have not been received. The Arsenic Acid Task Force continues to develop data to support the reregistration of arsenical wood preserva tives. The Task Force completed an aqueous availability study, determining the leach rates of metals from arsemcal-treated woods in a variety of leaching media, and sub mitted it to EPA. The Task Force was the first registrant group to perform this type of testing and has made the testing protocol available to other registrants that must generate this type of leaching data. The Formaldehyde Task Force completed the determina tion of formaldehyde levels in the headspaces of paint cans containing various formaldehyde donor biocides. An evaluation of formaldehyde off-gassing from a room painting study is in progress. Results from these studies will help paint manufacturers to decide whether label warnings are required on paint containers. PLANS: The Panel will continue its legislative activities throughout this session of Congress. In addition to its involvement in FIFRA reauthorization activities, the Panel also will monitoring Clean Water Act reauthorization, toxic use reduction, and pesticide export restrictions. The Panel also will continue to monitor state legislative and regulatory actions and to undertake advocacy to protect industrial biocide interests where necessary. A high level of activity in the regulatory arena is expected throughout the next year. The Panel will continue its participation in developing and implementing improved data compensation procedures. Further, the Panel will continue its efforts to streamline registration procedures and to ensure that EPA adopts appropriate registration data requirements for industrial biocides. Brominated Flame Retardants Panel HISTORY; The Panel originally formed in 1985 under the auspices ot the Fire Retardant Chemicals Association, and became a CF1EMSTAR panel in 1990. The Panel formed to address: the inclusion of brominated flame re tardants in EPA's proposed analytical test rule on dioxins and furans; the publication of pyrolysis studies demon strating that brominated dibenzodioxins and dibenzofurans may form from brominated diphenyl ox ides; and. the Interagency Testing Committee's recom mendations for health and environmental effects of cer tain brominated flame retardants. ACCOMPLISHMENTS: In 1991. EPA published a pro posed test rule requiring health, environmental, and chemi cal fate testing on five brominated flame retardants with an estimated testing cost of SI 1-19 million. The Panel submitted extensive comments on the proposed rule. In 1992. EPA announced an opportunity for negotiation on all pending TSCA Section 4 test rules, and solicited test proposals on these rules from industry. In response to the EPA request, the Panel submitted a science-based tiered testing approach with an estimated testing cost of $6 mil lion. EPA concluded its evaluation of the proposal in 1993 and announced that it will enter into a negotiated testing plan on the five brominated flame retardants. Negotia tions have not yet been initiated by the EPA. An addi tional twenty-two brominated flame retardants had been under consideration for testing by EPA. In November, the TSCA Interagency Testing Committee issued its 33rd Report removing these twenty-two compounds from con sideration due to their relatively low production and use levels. The Panel has continued to work with the Organization for Economic Cooperation and Development and the World Health Organization in compiling accurate infor mation on brominated flame retardants. Panel represen tatives participated in a July WHO meeting where the En vironmental Health Criteria document for polybrominated diphenyl oxide was finalized. The Panel continues to participate in a review of Environmental Health Criteria Documents on Polybrominated Diphenyl Oxides, Tetrabromobisphenol A and Derivatives, and Other Bro minated Flame Retardants. The Panel continued to play an important role in evaluating reports on brominated flame retardants developed under the OECD Risk Reduc tion Program, and in December submitted comments on the Draft Status Report. Panel representatives met with A Ret CMA 030856 A Report on the Year 1993 1994 CHCMSTAR the EPA to discuss the OECD Risk Reduction Program, and responded to an OECD survey requesting informa tion on specific aspects of'the pilot program. The Panel sponsored a project to evaluate reports detect ing the existence of polybrominated diphenyl ethers in env ironmental samples. The Technical Committee is pre paring a recommendation to the Panel for additional test ing to evaluate the bioavailabilitv and bioconcentration potential of brominated diphenyl ethers. The Panel has continued to address issues such as bromine recycling and the use of brominated flame retardants in electronics equipment, and is considering proposals to perform a benefits analysis on brominated flame retardants. The Panel published a newsletter in April to provide a current information to customers, users, and others with an inter est in brominated flame retardants. The newsletter has been a huge success with copies distributed in the U.S., Europe. Israel and Japan. Member companies completed sponsored testing to determine levels of polybrominated dibenzodioxins and dibenzofurans in commercial samples of eight brominated flame retardants under the TSCA Section 4 Dioxins and Furans Analytical Test Rule. ing this fall. The Panel will continue to monitor U.S. and international regulatory and env ironmental issues related to brominated flame retardants and will undertake addi tional projects as appropriate. Butadiene Panel HISTORY: The Panel formed following EPAs consider ation of butadiene under TSCA Section 4( f). The Panel collects and evaluates information needed to assess safety, environmental, and health issues arising from production, storage, transportation, use. and disposal of butadiene ACCOMPLISHMENTS: The Panel completed a com prehensive review of the SI.5 million butadiene research program. As a result of the review, the research program was refocused to include examination of a reproductive end point. The new program has a decreased focus on the mutation and biomarker endpoints in recognition of research being conducted by other parties. In addition, the Panel completed the major studies on 4vinylcyclohexene required under a TSCA Section 4 Con sent Order. The Panel discussed current issues and activities related to brominated flame retardants at several workshops and conferences: OrgaBrom '93 in Jerusalem, Israel. July 1993: a Panel sponsored workshop in Crystal City, Virgina. September 1993: a workshop sponsored by the Panel in conjunction with the Fire Retardant Chemical Associa tion in Tucson. Arizona, October 1993 a workshop spon sored by the Panel in conjunction with the Fire Retardant Chemical Association of Japan in Osaka and Tokyo, Ja pan, May 1994; and the Business Communication Con ference in Stamford. CT in May 1994. PLANS: The Panel will monitor EPA activities in re sponse to the TSCA Section 4 testing proposal, and will continue to work with OECD and WHO in their efforts to compile information on brominated flame retardants. The Panel will address environmental fate issues, and spon sor a project to assess the benefits of brominated flame retardants. The Panel will hold a workshop in October 1994 in Lon don, UK, in conjunction with the European Brominated Flame Retardant Industry Panel, and will make presenta tions at the Fire Retardant Chemical Association's meet The Butadiene Panel merged with the Olefins Panel to form the new Olefins Panel. The new Panel will cover advocacy and research needs for all chemicals of interest to ethylene manufacturing. At present these chemicals include ethylene, propylene, butadiene and 4v inylcyclohexene. PLANS: The new Olefins Panel will reorganize to ad dress issues of concern to ethylene manufacturers. For butadiene, the Panel will await the final rule for the OSHA workplace standard on butadiene which is expected.in late 1994. The Panel will continue its research activities and begin to apply the research results to risk assessment. In addition, the Panel will complete the final test required by a consent order on 4-vinylcyclohexene. In the advocacy arena, the Panel will begin discussions with regulatory agencies on the appropriate cancer risk assessment approaches for butadiene, and will continue to monitor and comment on the Clean Air Act Rulemakings involving butadiene, including modifica tions (section 112G) and Mobile Sources rulemakings. -- D-7 CMA 030357 CHEMSTAR A Report on the Year 1993-1994 Butylated Hydroxytoluene Panel HISTORY: The Panel was organized to conduct the re search and advocacy necessary to support the continued use of BHT in food additive applications. In 1978, the Panel tiled comments in response to an FDA proposal for intertm regulations requiring testing to resolve safety questions. To date. FDA has not issued an interim regu lation. The Panel submitted a Citizen Petition in 1986 requesting that FDA issue a regulation recognizing a prior sanction for use of BHT. In 1991. the Panel submitted additional information that contained a review of studies previously submitted and information regarding the EBMA's Chronic Toxicity Study of BHT. The Role of Hepatocellular Injury in the Chronic Toxicity of BHT, and again requested that FDA issue a regulation acknowledg ing the prior sanction status of BHT. To date, the FDA has made no decisions regarding the Petition. ACCOMPLISHMENTS: The Panel continued coopera tive efforts with the FDA, the International Life Sciences Institute, and the European BHT Manufacturers Associa tion through information exchange. PLANS: The Panel will continue to cooperate with the FDA in its evaluation of BHT and will maintain liaison with EBMA and ILSI through information exchange. that CS, should be deleted from the upcoming reproduetiv e and developmental endpoint test rule based on NTP\ activ dies. The Panel has been following OSHA reform legislation with a focus on the provision which would reinstate the 1989 Air Contaminants Standard which was vacated by the court. The Panel has worked with a consortium of trade associates and convinced OSHA to support a modi fication to this provision which preserves settlement ar guments arising from the law suit. Both the House and Senate bills currently contain the modified wording. The Panel submitted comments opposing the listing of H,S under EPCRA 313 and is currently working w ith the American Petroleum Institute and American Forest Prod ucts Association to convince EPA to withdraw H.S from the final rule. The Panel commented on the EPA docu ment "Principals of Neurotoxicity Risk Assessment." The Panel also commented on the proposed Universal Treat ment Standard for CS, under RCRA land disposal restric tion rules. The Panel met with EPA and provided data that show that the UTS forCS, is not feasible for the vis cose process. Most recently, the Panel provided data to ACGIH as it begins development of a Threshold Limit Value for CS,. Carbon Disulfide Panel HISTORY: Companies manufacturing carbon disulfide and using it to produce rayon and cellulose fibers by the viscose process joined together in 1976 as the Inter-Industry Committee on Carbon Disulfide. In 1991, this group became a CHEMSTAR Panel. The Panel's mis sion is to interact with regulatory agencies and other ap propriate organizations on safety, health and environmen tal issues involving carbon disulfide. ACCOMPLISHMENTS: The Panel has been advocat ing an appropriate reference concentration for CS, with EPA. To support this activity, the Panel completed a com prehensive literature rev tew and analyzed the best data to support a "no effect" level in humans. The Panel met with EPA to discuss its findings and has supplied data and comments. In addition, the Panel met with the Na tional Toxicology Program to discuss research plans for CS,. The Panel obtained an outline of the plan and proto cols from NTP and submitted them to EPA advocating PLANS: The Panel will continue discussion with EPA and NTP on the testing of carbon disulfide and on the development of an appropriate reference concentration. The Panel will follow OSHA reform legislation closely, and ensure that the provisions of the settlement agree ment are incorporated into any new legislation. Also, the Panel will continue to monitor EPA's activities in devel oping TSCA test rules on carbon disulfide. The Panel will continue its reanalysis of the NIOSH data to support both a TLV and reference concentration and present its findings to EPA and ACGIH. Carrier Assessment Council HISTORY: The Council formed to address carrier assess ment issues of concern to the CMA membership. A ma jor goal of the Council is to help interested CMA mem bers meet the carrier safety provisions (3.1 and 3.2) of the Distribution Code of Management Practices. These provisions require that CMA members; establish a pro cess for qualifying carriers of all modes and types; evalu- o*i CMA if c 4 Report on the Year 1993-1994 CXEMSTM ate carrier', for safety fitness and regulatory compliance; and, provide feedback and suggestions for improvement to carriers on their safety performance. Activities to ac complish this goal include developing assessment proto cols. promoting their use and working with the Distribu tion Committee to optimize assessment protocol value to chemical shippers and carriers. KCCOMPLISHMENTS: The Council completed devel opment of the Highway Carrier Assessment Protocol and completed pilot field testing of the final protocol. As sessment protocol developments were initiated for rail, barge and container vessel modes. Active participation of the carriers is a hallmark of all protocol development. Work on these three protocols was 90T completed as of May 31. The Highway Protocol was referred to the CMA Distribution Committee Implementation Work Group, and Council members are working to ensure a smooth transi tion from the development to the implementation phase. Final drafts of the remaining protocols are being utilized by the Distribution Committee to facilitate use planning. PLANS: The Council will complete rail, barge and con tainer vessel assessment protocols in July 1994, Chemical Distributors Council HISTORY: The Council formed to address issues of con cern to chemical distributor members of CMA. Council acttv tties include: collecting, evaluating and disseminat ing information on issues that affect chemical distribu tion; and advocating the interests of the chemical distribu tor sector. The Council maintains a strong interaction with the National Association of Chemical Distributors through that Association's formal membership in the Council. ACCOMPLISHMENTS: The Council developed the Re sponsible Care1 Product Stewardship Code Assessment Protocol for Distributors. Although primarily developed for use by distributors, the protocol can be been useful in assessing manufacturers' in-house distribution operations PLAXS: After wider dissemination of the Chemical Dis tributors Self-assessment Protocol developed in 1992 and the new implementation aid for the Product Stewardship Code, the Council will terminate operations. Chlorinated Pool Chemicals Panel HISTORY: The Panel formed to promote safety prac tices worldwide in the processing, packaging, warehous ing. transportation, and use of chlorinated pool chemi cals. Panel members include producers of calcium hy pochlorite and chlorinated isocyanurates worldwide. ACCOMPLISHMENTS: The Panel submitted its re search report on chloroform releases from swimming pools to the California Air Resources Board. The Trans portation Task Group's bulletin on the transportation of calcium hypochlorite and chlorinated isocyanurates was finalized and prepared for publication. The Panel contin ued to research the "self-reactive" classification recom mended by the U.N. Expert Committee on the Transport of Dangerous Goods and discussed the issue with the U S. Department of Transportation. PLANS: The Panel will continue to work with DOT on the classification of specific pool chemicals. The trans portation bulletin soon will be available for distribution to shippers of pool chemicals and personnel responsible for in-transit storage. In addition, the Panel will continue distribution of its training videotapes for fire and emer gency response personnel and guidelines for safe han dling and storage of pool chemicals. The group will pro ceed with monitoring various fire and building code regu lations and other requirements affecting chlorinated pool chemicals. Chlorine Chemistry Council HISTORY: The Council was formed to promote public understanding of chlorine and chlorine-related products. Council activities contribute to the public policy debate on these chemicals; heighten public awareness of the ben efits of these products; and facilitate risk-benefit analy ses through collection and development of solid scien tific data on health, safety and environmental issues. The Council conducts advocacy, outreach, product stew ardship and scientific data development in close coordi nation with two related trade associations, the Chlorine Institute and the Vinyl Institute. The Council member ship includes producers and users of chlorine and chlo rine-related products, as well as organizations and com panies in interested industries. The Council also encour- D- CnA 03 CHEMSTAR A Report on the Year 1993-1994 ages other organizations and associations, nationally and internationally to address chlorine and chlorine-related public issues. ACCOMPLISHMENTS: This year three key issues on the federal level required comprehensive advocacy and outreach efforts. The Council was effective in prevent ing anti-chlorine prov lsions in the Clinton administration s executive order on recycled paper and forestalling pro posed Clean Water Act provisions which were aimed at banning chlorine chemistry. EPA's Dioxin Reassessment is being addressed by coalitions of other interested par ties. a scientific review and a very proactive outreach/ education program to the media and key policy influencers. Seven state initiatives which would have in appropriately affected chlorine chemistry were deflected during the year. The CCC-sponsored work by a panel of scientists on an "Interpretative Review of the Potential Effects of Chlorinated Materials on Human Health and the Environment" was in the August v olume of the Jour nal of Regulatory Toxicology and Pharmacology. PLANS: The Council's public policy goals and current key objectives were defined in July 1994 and compre hensive action plans are being developed and imple mented. A major outreach/communications effort will be maintained on these issues. State government rela tions and grassroots programs are being significantly up graded to state of the art programs. The Council's portfo lio of science programs will expand with those of its glo bal partner associations coordinated by the International Group of Chlorine Chemistry Associations. The Council is also w orking to enhance stewardship of chlorine chem istry by all industry sectors consistent with Responsible Care . Chlorine Dioxide Panel HISTORY: The Panel formed in anticipation of an EPA proposal to regulate chlorine dioxide under the Safe Drink ing Water Act by 1993. In addition, the state of Califor nia contracted for a risk assessment on chlorine dioxide and sodium chlorite. The Panel aims to gather, review, generate, and disseminate information on chlorine diox ide and its precursors, sodium chlorite and sodium chlo rate. The Panel monitors and interacts with regulatory agencies and fosters scientific communications. Primary focuses ot the Panel are generation, applications, health effects, safety, and test methods of chlorine dioxide. ACCOMPLISHMENTS: The Panel completed all Phase 1 requirements for EPA's FIFRAdata call-in. The Panel also completed all testing required for FIFRA Phase IV Reregistration. The Panel continued to work closely with the EPA Office of Drinking Water on the upcoming Dis infection Disinfection By-Product Rule standards for chlo rine dioxide and sodium chlorite. The Panel is conduct ing a two generation reproductive study on sodium chlo rite in rats via drinking water. The rangefinder portion of the study is underway, the definitive study will be com pleted next year. At the Spring planning meeting the Panel developed and accepted a new organization structure. The structure consists of tour new task groups with specific goals and objectives. The group has worked closely with WHO and is tracking the chlorite issues from an interna tional perspective. The Panel's final studies have been sent to the state of California for its sodium chlorite "datacall-in". The Panel sent comments to the EPA in regard to its draft proposal that would add chlorine dioxide to the SARA Section 313 reporting list. The Panel has ex ecuted the Data Ownership Contract forToxicology Stud ies generated by the Panel, and all studies have been dis tributed to each participating member. The data is confi dential under FIFRA, and all parties must abide by the provisions of the signed agreement. The data is compensable under FIFRA. PLANS: Panel representatives will continue to interact with EPA on the FIFRA data call-in and reregistration. The Panel will undertake additional testing which EPA may require under FIFRA Reregistration Phase V. The Panel will review and comment on EPA's Chlorine Diox ide Health Advisory Report which is the basis for the up coming Drinking Water Standard. Interaction with EPA on its negotiated test rule approach for the Disinfection By-Product Rule which includes chlorine dioxide and sodium chlorite, will be a major Panel focus through 1994 and 1995. The Panel's two-generation reproductive study should be complete by October 1995. The Panel has fo cused very actively in tracking chlorine dioxide in the international arena: this will be a big pan of 1995 Panel activities. The Panel will also seek to obtain sodium chlo rite data to assist EPA in preparing water quality criteria for chlorine dioxide. o-io A Rat iCl Ci CMA 030860 A Report on the feat 1393-1994 CHBASTAR Chlorobenzenes Panel HISTORY: The Panel formed to sponsor voluntary re search on chlorobenzenes. The focus on research remains, but now the emphasis is on completing mandated research on health and environmental effects. The Panel contin ues to provide technical support for the advocacy activi ties of the Chlorobenzenes Producers Association, an af filiate of the Synthetic Organic Chemical Manufacturers Association. ACCOMPLISHMENTS: The Panel continued to spon sor research to meet 1,2.4-tnchlorobenzene (TCB) onco genicity testing requirements under TSCA Section 4, The Panel also sponsored research to address a FIFRA data call-in on p-dichlorobenzene <PDCB). PLANS: The Panel's TSCA testing program will be com pleted in June 1994, when the final reports on the TCB dietary oncogenicity studies in rats and mice are submit ted to EPA. Acute and subchronic neurotoxicity studies on PDCB required under the FIFRA data call-in have been completed Final reports will be submitted to EPA in Sep tember 1994. There are presently no plans for future re search. Cobalt Panel HISTORY: The Panel formed to interact with regulatory agencies and other appropriate organizations on cobalt safety, health, and environmental issues. The Panel first focused on the 1990 IARC review of cobalt and cobalt compounds. Panel interaction with the Cobalt Develop ment Institute provided valuable information for use in the IARC review. affecting cobalt. Panel members will continue to interact with the ACGIH BEI Committee, and will maintain work ing relations with CDI, Cresols Panel HISTORY: The Panel formed in 1984 in response to a TSCA Section 4 test rule. Testing required under the test rule was completed in 1990, and after evaluation of the test data in its Risk Management process, EPA decided to take no further action on cresols, but referred the three cresoi isomers to OSHA and NIOSH for their consider ation. The Panel has worked with the EPA Chemical Test ing Branch. Office of Solid Waste, and the National Toxi cology Program to ensure that logical and scientifically sound testing programs are conducted on cresols. ACCOMPLISHMENTS: In July, the Panel submitted comments to the Carcinogen Risk Assessment Verifica tion Endeavor Workgroup urging it to re-review the IRIS Database's classification of cresols as "possible human carcinogens." As a follow-up to the July comments, the Panel made a presentation to members of the CRAVE Workgroup and the EPA Office of Health and Environ mental Assessment in February. The Panel's presentation summarized the reasons why existing studies do not sup port a carcinogen classification for the cresols isomers, EPA has indicated that cresols will likely be reconsidered by the IRIS Workgroup in late 1994. PLANS: The Panel will continue to monitor cresols regu latory issues and interact with the agencies, as appropri ate. ACCOMPLISHMENTS: The Panel presented oral testi mony to the ACGIH Biological Exposure Index Commit tee, and submitted comments to the EPA on the proposed assignment of reportable quantities to broad generic cat egories of chemicals. The Panel addressed environmen tal issues related to cobalt compounds, and has continued to cooperate with the Cobalt Development Institute through meetings and information exchange. PLANS: The Panel will continue to monitor North Ameri can and European regulatory and environmental issues Crystalline Silica Panel HISTORY: The Panel formed to address the 1987 Inter national Agency for Research on Cancer listing of crys talline silica as a '`probable" carcinogen. Classification as a probable carcinogen automatically requires U. S. firms to comply with OSHA Hazard Communication Standard cancer labelling requirements. The Panel began with nine members, dedicated to bringing together the silica indus try to speak with a strong united voice on scientific, regu latory and analytical concerns stemming from the IARC classification. 0-11: CMA 030361 CWMSTM A Report on the Year 1993-1394 ACCOMPLISHMENTS: The Panel continued to have a membership of over 40 organizations. The Panel, along w ith the American Mining Congress, the International Diutomite Producers Association and the California Mining Association, completed a focused review of crystalline silica literature and risk assessments performed to date. The Panel also co-funded a separate epidemiology review and a toxicology review. The three science reviews formed the basis of input to the States of California and North Carolina. These States are attempting to develop recommendations for "acceptable" levels of environmen tal exposure to silica. The Panel also sponsored a paper on the public policy issues of further regulating crystal line silica, that has been submitted for publication. In April the Panel co-sponsored with Johns Hopkins University an international conference on crystalline silica health effects in Baltimore, Maryland. The Panel also submitted comments to NIOSH on its recommended crys talline silica exposure limit in its draft Respirable Coal Dust Criteria Document. The proceedings of the Panel's 1992 international sym posium on methods for detecting and analyzing crystal line silica content were published in a peer-reviewed jour nal in February. The four Panel sponsored, state-of-theart reviews of analytical methods used to detect and quan tify crystalline silica in bulk samples are still awaiting publication. The Science and Technical Advisory Group turned its attention to determining the cystalline silica content of ambient air. PLANS: The Panel will continue to urge that public policy decisions concerning crystalline silica be based on a bal anced review of the scientific literature concerning both cancer and non-cancer issues. The Panel will follow closely efforts in California, and within EPA, to: increase regulatory requirements; and, perform quantitative risk assessments of crystalline silica. The Panel also is com mitted to maintaining industry input as policy makers wrestle with generic issues relating to risks and exposure to substances, including crystalline silica. The Panel will track development of a new NIOSH criteria document for crystalline silica, any new OSHA or MSHA Permis sible Exposure Limits or ACGIH Threshold Limit Values and discussion of silica in revisions to EPA's PM 10 regu lations. Comments will be submitted as necessary. The Panel will consider a cooperative pilot project to deter mine the range of airborne respirable crystalline silica in the general environment. As other opportunities arise, the Panel will express con cern to Congress, agencies and the administration on the use of automatic triggers for labeling decisions. The Panel will maintain efforts to expand the membership and in crease financial resources to respond to expanding issues. Cumene Panel HISTORY: The Panel formed as a result of the Inter agency Testing Committee's designation of cumene for priority testing under TSCA Section 4. The Panel's ob jective is to collect information that will allow assess ment of health and environmental effects arising from pro duction, storage, use, and disposal of cumene. ACCOMPLISHMENTS: The Panel completed the test ing mandated underTSCA Section 4 and conducted a vol untary subchronic inhalation study on rats to assess ef fects seen in the first subchronic study. After reviewing the data. EPA concluded that the TSCA Section 4 test data support a low hazard concern for cumene and that, based on current hazard and exposure information, cumene is of low risk to humans. In 1990. through the legal challenge of a test rule, the Panel sought definition of "substantial" exposure limits by which the Agency can require testing under TSCA Section4(a)( l)(B). In 1990, the Court ruled that EPAdid not justify the test rule for cumene because meaningful criteria for defining "substantial or significant" environ mental release and human exposure had not been estab lished. The Court remanded the test rule to EPA and di rected the Agency to provide a rationale for its exposure findings. The Agency published the "B" Policy in May 1993. PLANS: The Panel has volunteered cumene for Phase 4 of the OECD SIDS program and plans to submit a dos sier in the near future. The Panel will continue to interact with EPA and other agencies on hazard and risk assess ment issues. Manuscripts of the testing data are being prepared and submitted for publication in peer-reviewed journals. The Panel continues efforts to have the cumene test rule data evaluated by IRIS. D-1X CMA 030862 A Report on the Year 1993-1994 emtSTAR Cyclohexane Panel HISTORY: The Panel formed in response to the Inter agency Testing Committee's "intent-to-designate" cyclo hexane tor priority testing under TSCA Section 4. Dur ing the past year. Panel efforts have focused on negotia tion and litigation activities, ACCOMPLISHMENTS: A proposed TSCA Section 4 test rule on cyclohexane was published by EPA in 1987. Between 1987 and 1992. EPA postponed issuance of the final test rule. During this period, the Panel submitted background information on the use. production, release, and safety of cyclohexane. In 1992. EPA launched an "open-season'' initiative in which the Agency solicited from industry testing proposals for chemicals with pend ing TSCA test rules. The Panel responded by submitting a testing proposal on cyclohexane and by stating its in tent to negotiate with EPA. In February 1993. the Panel initiated negotiations with EPA for a TSCA Section 4 enforceable consent agree ment. As part of the negotiation process, the Panel sub mitted a written testing proposal and gave an oral presen tation to EPA describing the studies it was prepared to conduct. The Panel's testing proposal included numer ous protocol enhancements beyond the standard EPA test ing guidelines. The Panel offered to conduct all of the studies in EPA's 1987 proposed test rule, with the excep tion of two oncogenicity studies. The Panel presented toxicology, exposure, and release data indicating that there was no scientific basis for conducting oncogenicity stud ies on cyclohexane. Based on the Panel's written and oral comments, EPA accepted the Panel's testing proposal and further agreed to delete the oncogenicity study re quirement from the testing program. Unnecessary onco genicity testing would have cost cyclohexane producers an estimated 2 million dollars. After review of future emissions data and data from the completed testing pro gram, EPA may revisit the need for oncogenicity testing in a future rulemaking. By the end of the fiscal year, the Panel and EPA had resolved all major negotiation issues and were near settlement on a final consent agreement. During the past year, the Panel also was involved in liti gation activity. In May 1993, EPA issued its new TSCA 4(a)( 1 )(B) policy outlining quantitative criteria for an ex posure finding to justify chemical testing. The Panel re sponded by filing a petition for review of the "B policy" with the U S. Court of Appeals. Tenth Circuit. In films the petition for review, the Panel's intent was to preserve its legal right to challenge the B policy if and when a final test rule on cyclohexane was promulgated. The Panel's intent also was to stay the judicial challenge until negotiations with EPA on a consent agreement were com plete. As anticipated, the Court dismissed the Panel's pe tition on grounds it was not ripe for review; however, the Court noted that the Panel may renew its challenge when the B policy is specifically applied in a test rule. This was the Panel's desired outcome because it preserves the right of the Panel and other industry groups to legally challenge the B policy in the event a TSCA Section 4 test rule is issued. PLANS: The Panel expects to successfully complete TSCA consent agreement negotiations with EPA. The Panel will make final decisions regarding placement of studies with laboratories and will make other preparations as necessary for initiating its testing program. Olbenzofurans/Dibenzodioxins Panel HISTORY: The Panel formed when the Environmental Defense Fund and National Wildlife Federation filed a TSCA Section 21 Petition. In addressing the EPA re sponse, the Panel commented to the Agency on proposed rules under TSCA Sections 4 and 8. Final rulemakings on the two sections require analyses of chemicals for the presence of dibenzofurans and dibenzodioxins as impu rities and the reporting of production, processing, use. exposure, and disposal data. ACCOMPLISHMENTS: The Panel funded an independant analysis of the original data used to prepare the NIOSH epidemiology study of workers exposed to 2,3,7,8-TCDD (dioxin). The last phase of the project is being co-funded with the CMA Chlorine Chemistry Coun cil (CCC). The Panel worked cooperatively with the CCC to set up a Dioxin Work Group, within the Council, to address di oxin related activities, particularly those surrounding the EPA reassessment of the toxicity of dioxins. PLANS: The Panel will oversee the reanalysis of the NIOSH study data through completion. The Panel will then reassess whether to terminate its activities. 0-l3,i CMA 030863 CHEMSTM A Report on the few 1933-1394 Diisocyanates Panel HISTORY: The Panel formed to develop and dissemi nate information on the safe handling of diisocyanates, including: TDI, MDI. hexamethylene dusocyanate. and, methylenebis-dicyclohexyl diisocyanate. Monitoring im pending regulations affecting the production or use of di isocyanates and developing responses as needed also are key Panel activities. ACCOMPLISHMENTS: The Panel worked with EPA to ensure that all necessary data are available to make informed decisions during implementation of Clean Air Act Title III. The Maximum Achievable Control Tech nology Task Group explored the effect of the proposed Hazardous Organic National Emissions Standards for Hazardous Air Pollutants (HON) on member companies' operating procedures, and the Panel commented on the proposed HON Rule. Following the issuance of the Early Reduction Rule, the Panel filed a judicial challenge to remove methylenediphenyl diisocyanate (MDI) from the high pollutant risk list. The Panel submitted a petition to EPA to raise the Reportable Quantity for MDI and awaits a formal response from the Agency. As a follow-up to the Agency's Risk Management-! assessment of the iso cyanates and in preparation for the RM-2 process, the Panel developed a position paper on the pulmonary ef fects of MDI. The Emergency Response Preparedness Guidelines for MDI and TDI were completed under the Panel's sponsorship. The TSCA Nomenclature Task Group interacted with EPA to address optimum definition of the dominant nomenclature for MDI and TDI products on inventory lists world-wide. These discussions resulted in the publication of an instruction manual, "Nomenclature for Diisocyanates TDI, MDI and Derivatives," sponsored by the Panel and the Polyurethane Division of The Soci ety of the Plastics Industry, Inc. The manual contains the Task Group's recommendations for TDI and MDI and their derivatives for inclusion in the 1994 correction of the TSCA Inventory. Panel comments were submitted to the state of Michigan on its proposed Occupational Health Standard for Isocyanates. PLANS: The Panel will submit comments to EPA on Section 112(g) of the Clean Air Act. Members will con tinue to work with the states on various initiatives, such as California's Proposition 65 implementation, the Michi gan Occupational Health Standard for Isocyanates, and various state air toxic regulations, as they develop. The Panel awaits the Court's decision on the judicial challenge to the Early Reduction Rule. If the ruling is in the Panel's favor, efforts to delist MDI from EPA's high pollutant nsk list under the Rule will continue. Also impending is EPA's completion of the adjustment of the RQ for MDI to 5,000 pounds. The Panel will continue to interact with EPA and its Canadian and European counterparts on imple mentation of the Nomenclature Task Group's recommen dations for MDI and TDI products for uniform correc tion of inventory lists worldwide. Conversations between the Panel and the Interagency Testing Committee on ap propriate research information for the isocyanates will continue. The Panel will become an active participant in EPA's Risk Management-2 process for isocyanates. As a volunteer in Phase 4 of the OECD High Production Vol ume Existing Chemicals Voluntary Testing Program, the Panel will submit a Screening Information Data Set dos sier on MDI to the US Representative in June 1994. Other Panel initiatives will be to communicate the industry's interests in issues such as Hazardous Waste Identifica tion, TSCA Section 5 restrictions, and Toxic Use Reduc tion to the EPA. The Panel also will continue to interact and coordinate activities with the Society of the Plastics Industry, the Polyurethane Foam Association, the Inter national Isocyanate Institute, and the European Isocyan ates Producers Association. Dinitrotoluenes Panel HISTORY: The Panel initially formed to conduct research on dinitrotoluenes. Under a voluntary research agree ment with EPA and German regulatory agencies, the Panel conducted a pharmacokinetics study. The pharmacoki netics study was completed in 1991 and results have been submitted to the various regulatory agencies. Panel mem ber companies are awaiting the outcome of EPA's evalu ation of the data. Current Panel activities focus on regu latory advocacy. ACCOMPLISHMENTS: During the past year, the TSCA Interagency Testing Committee designated 2,4-DNT for dermal absorption testing. The Panel submitted techni cal comments advocating that dermal absorption testing of 2,4-DNT is unnecessary. The Panel is waiting for ITC's response. 0-14) - A Re, ft ft CHA 030864 A Haport an tha faar 1993-1994 CHemTAK PLANS: The Panel intends to internet with German and U.S. agencies as results of its voluntary testing are as sessed. The Panel also plans to monitor ITC dermal ab sorption testing requirements. Future plans include pub lishing research results. Ethylene Glycol Panel HISTORY: The Panel formed in 1986 to augment the ethylene glycol toxicological data base. The Panel then completed a voluntary testing program, focusing on de velopmental toxicity and pharmacokinetics research in mice and rats. Ethylenebis(stearamide) Panel HISTORY: One of the sixty-two chemicals assigned to Phase 3 of the OECD High Production Volume Existing Chemicals Voluntary Testing Program is N,N'-1,2ethanediylbis-octadecanamide, also known as N.N'-ethylene-bts(stearamide) (EBS). Manufacturers of EBS formed the Panel to voluntarily collect, generate, and evaluate information required to complete a Screening Information Data Set (SIDS) dossier for evaluating envi ronmental and health toxicity potentials of this chemical. ACCOMPLISHMENTS: The Panel developed a SIDS dossier for EBS and worked with EPA to ensure that all available data and data gaps are identified for consider ation in the OECD process. PLANS: Following notification of the recommendations agreed upon during the Phase 3 OECD SIDS Review Meeting in Paris, the Panel will consider the recommen dations concerning EBS and then take appropriate action.. Ethylene Bichloride Panel (Completed) HISTORY: The Panel formed to address federal and state agencies in all safety and health issues arising from the production, distribution, and use of ethylene dichloride. ACCOMPLISHMENTS: During its time as a CHEMSTAR group, the Panel evaluated scientific literature, iden tified data gaps, and, in an effort to improve the research data base, completed a voluntary testing program which included chronic inhalation, metabolism, and teratoge nicity studies. The Panel also responded to regulatory issues affecting EDC from various federal and state agen cies, such as ATSDR, EPA, OSHA, and California EPA. PLANS: The Panel completed its tasks and agreed to terminate operations. No other group has been identified which will address EDC issues. ACCOMPLISHMENTS: As a result of the Ethylene Gly col Panel's advocacy efforts, EPA issued a proposed rulemaking in November to adjust the reportable quantity (RQ) for ethylene glycol from the statutory CERCLA default of one pound to 5,000 pounds, based on a review of EG toxicity and environmental data. In addition, the Panel was successful in correcting the classification of ethylene glycol in the proposed Section 112(g) rulemak ing before that NPRM was published. The Panel also submitted extensive comments to the Agency for Toxic Substances and Disease Registry (ATSDR) on its techni cal report on ethylene and propylene glycol. The Toxi cology Research Task Group completed two research projects, an in vitro skin penetration study and a plasma metabolite identification study, and is in the midst of hav ing several research projects published, including a per spective of ethylene glycol developmental toxicity. PLANS: The Ethylene Glycol Toxicology Research Task Group will continue its investigation into the mechanism of EG developmental toxicity by conducting a whole em bryo culture assay on EG and a study to determine the relationship between developmental toxicity effects and the onset of metabolic acidosis. The Panel will monitor the status of the RQ rulemaking within EPA and the final technical report from ATSDR. In addition, the Panel will provide input into ACGIH during its review process of ethylene glycol's TLV values. The Panel will develop an appropriate strategy for disseminating available EG data to interested parties. Ethylene Glycol Ethers Panel HISTORY: The Panel formed to develop an adequate toxicity data base on ethylene-based glycol ethers, pro vide information to users and government agencies on the safety of the chemicals, and promote scientifically sound regulatory action. CMA 030865 CHCMSTM A ffepart aa tht fear 1993-1994 ACCOMPLISHMENTS: Results of several year's worth of voluntary and required toxicology testing were high lighted this past year, with papers presented at an interna tional symposium and a number of publications published or pending. A primary focus of the last year, the Interna tional Symposium on Health Hazards of Glycol Ethers, was cosponsored by the U.S.. Netherlands, and France and held in Nancy. France in April. Four members of the Toxicology Research Task Group gave oral and written presentations on ethylene glycol butyl ether, diethylene glycol butyl ether and triethylene glycol ethers. The Panel also prepared informational packages describing its re search and advocacy programs for members of the inter national audience. A number of papers given at the sym posium will also be published in the peer-reviewed lit erature. Completed research over the past year included further refinements to a physiologically-based pharmacokinetic model of EGBE and a unique human exposure protocol to assess the nature of dermal uptake from vapors. The latter study responds to earlier reports that the skin could potentially be a much greater route of exposure than gen eral biological considerations would predict. The Panel sponsored active involvement in an ECETOC Technical Committee developing an Indicative Limit Value for a European Union occupational standard on EGBE. A representative of the Panel's TRTG participated in meetings throughout the year and all of the Panel's sponsored research on EGBE was supplied for the effort. An ECETOC Special Report has been published and trans mitted to the Scientific Expert Committee of the Euro pean Union. The Panel worked with the U.S. Department of Transpor tation to submit a paper to the United Nations Committee on the Transport of Dangerous Goods. The paper pro poses to change the United Nations and DOT classifica tion of ethylene glycol butyl ether from its current Pack ing Group HI Poisonous Substance class to non-regulated. This precedent-setting paper utilizes acute toxicity data in an alternative species, more relevant to human assess ment. The UN Committee will meet in July, 1994 to take action on the proposal. The Panel conducted a second and final effort to defeat a bill on glycol ethers proposed by Senator Tom Hayden in California. In its evolution, the bill's provisions ranged from criminalizing the use of certain members of the class to directing Cal-OSHA to carry out redundant and need less reviews. The Panel continued efforts to clarify and correct the in appropriate use of the term "glycol ethers'' in articles and statements characterizing toxicology, use and exposure information on the more than 30 different commercial products included in the chemical category. These ef forts included letters to the editor and other responses to popular press, trade and scientific journals, and the mass media. The Panel continue to seek avenues for relief from inap propriate regulatory actions listing glycol ethers as a cat egory of chemicals. Such regulations include those implementating provisions of the Clean Air Act and Re portable Quantities requirements under CERCLA. A pe tition to EPA on RQs is still pending Agency action. PLANS: The Panel will continue a focus on international activities and pursue a coordinated industry program with the Ethylene Glycol Ethers Sector Group of CEFIC. Panel members plan to meet with representatives of the Group this year and will also work to include members of an ad hoc Japanese consortium in the discussions. Voluntary research on EGBE will continue to be supported in the area of human risk assessment and species-specific mecha nisms of hemolysis. Ethylene Oxide Panel HISTORY: The Panel formed to evaluate the results of an animal study that may affect OSHA and EPA regula tory proceedings on ethylene oxide. The EOIC addresses many regulatory and scientific activities in an effort to provide agencies with enough information to make rea sonable and scientifically sound decisions on regulatory controls. ACCOMPLISHMENTS: The Ethylene Oxide Industry Council and Chemical Industry Institute of Toxicology continued cofunding a pharmacokinetics physiological modeling study being conducted at CUT. The study re sults will be very helpful in conducting ethylene oxide risk assessments, specifically mutagenicity risk assess ment. The EOIC continued working with the EPA on J C'riA 030866 A Report on the Year 1993-1994 CMMSTM ethylene oxide risk assessment. The EOIC worked with IARC as it revisited ethylene oxide. The epidemiology studies of ethylene oxide do not agree with the results of the animal studies and recent EOIC sponsored meta-analysis further illustrates this point. This point was carried to IARC during its ethylene oxide review. The final Haz ardous Organic NESHAPS was issued this past winter and the EOIC assessed how ethylene oxide may be af fected. The EOIC is sponsoring an ethylene oxide flame propagation study in two and twelve-inch lines. The EOIC Safety Task Group has had several information exchanges on ethylene oxide stewardship. vinylidene fluoride, hexafluoropropene, and tetrafluoroethene. PLANS: The Panel will respond to any issues regarding the results of its TSCA testing program, and will monitor other regulatory issues on fluoroalkenes. Hexamethylene Diisocyanate Panel HISTORY: The Panel formed to address the inclusion of HDI on the Interagency Testing Committee priority list of chemicals for testing under TSCA Section 4. PLANS: The CUT pharmacokinetics physiological mod eling study will continue, into its fourth year. The Toxi cology Task Group will review several ethylene oxide re productive studies and evaluate ethylene oxide carcino genicity risk assessment. In August the Group will host with CUT a joint planning meeting on mutagenicity risk assessment with EPA representatives, industry toxicolo gists and academicians. A scientific paper on the CUT research will be published this year. An international sym posium cosponsored with CIIT and EPA on mutagenicity risk assessment is planned for 1995. The ethylene oxide flame propagation study will continue through 1994. with a final report due in January, 1995. "Information Ex change" workshops focusing on safety and handling of ethylene oxide and on toxicology issues are planned for 1995. The Environmental task group will summarize the final HON Standards as it effects ethylene oxide manu facturing and use. They will also evaluate ethylene oxide exposure for ultimate use in risk assessment. The Indus trial Hygiene task group will publish an article on ethyl ene oxide protective clothing research. Fluoroalkenes Panel HISTORY: The manufacturers of fluoroalkene mono mers originally formed an ad hoc coalition to address the Interagency Testing Committee's 1980 designation of fluoroalkenes for priority consideration underTSCA Sec tion 4. The coalition reorganized as a CHEMSTAR panel when EPA issued the final test rule. ACCOMPLISHMENTS: In 1992, the Panel completed the requirements for the TSCA Section 4 test rule, which included mutagenicity, subchronic toxicity, and oncoge nicity on four fluoroalkene monomers -- vinyl fluoride, ACCOMPLISHMENTS: The Panel continued to wait for EPA to issue the final TSCA Section 4 test rule on HDI. In the meantime, the group commented on EPA's proposed rulemaking to adjust the reportable quantity for HDI from a statutory one-pound limit to 100 pounds. In addition, the Panel responded to the inclusion of HDI on EPA's proposed Toxics Release Inventory expansion list. PLANS: The Panel will proceed with the required test ing program when EPA issues the final rule. In addition, the Panel intends to contact DOT regarding HDI classifi cation under Hazardous Material Transportation Rule 181. The Panel will continue to track other regulatory issues affecting HDI. Hydrazine Panel HISTORY: The Panel formed to support hydrazine-re lated product stewardship activities. Panel members have reviewed and evaluated published and unpublished lit erature on the health effects of hydrazine in order to main tain a current, accurate point of reference for discussion of the safe use of hydrazine products. ACCOMPLISHMENTS: The Panel submitted comments to ACGIH on the proposal to lower the Threshold Limit Value for hydrazine from 0.1 ppm to 0.01 ppm. In re sponse, ACGIH has postponed the decision for another year so that its TLV Committee may further consider re search results. The Panel cooperated with the EPA in its Risk Management Review of hydrazine through meet ings and submission of other pertinent information. The Panel also and submitted a petition to the EPA for recon sideration of the weighting factor for hydrazine under the Early Reduction Rule. The Panel submitted analytical 1-17) CMA 030867 CHEMSTAH A Report an the Year 1993-1994 methods for analyzing hydrazine in water and soil to the EPA for consideration in the drafting of a proposed haz ardous waste identification rule under RCRA. and sup ported a petition for a new classification of hydrazine by DOT for 'less than 37<7r hydrazine", PLANS: The Panel will continue its product stewardship activities, and will work with regulatory agencies and other concerned organizations on matters relating to health and safety aspects of hydrazine. Hydrogen Fluoride Panel HISTORY: The Panel formed to provide a forum for U.S. and Mexican producers and shippers to share informa tion on safety in the manufacture, handling and transpor tation of, and emergency response procedures for, anhy drous hydrogen fluoride and hydrofluoric acid. ACCOMPLISHMENTS: The Panel expanded to include users and suppliers of raw materials as members and broadened its focus to include advocacy activities. The Management Group and Advocacy/Communications Task Group led the Panel's participation in EPA's Congressionally-mandated program to prepare a study of the indus try. The Panel also submitted to EPA an independent study of transportation incidents involving anhydrous HF. The Panel commented extensively on ATSDR's Draft Toxi cology Profile on HF. Members of the Medical & Toxi cology Task Group also worked with the CMA Health and Safety Committee to develop comments on ATSDR's draft protocols for emergency medical treatment of HF exposure victims, PLANS: The Panel will track a lawsuit filed against the California South Coast Air Quality Management District that banned specific uses of HF. The technical task groups will work toward completion of their recommended guide lines for industry safety practices. The Panel will con tinue to hold its Annual Meeting and Safety Seminar, Hydroquinone Panel HISTORY: The Panel formed in response to a TSCA Section 4 test rule published by EPA in 1984. The cur rent focus of the Panel is voluntary research. In 1990, the Panel completed a TSCA Section 4 testing program for hydroquinone. All required data and reports have been submitted to EPA. and the Panel has prepared a Research Summary Report outlining the findings and conclusions of the various studies. Completed TSCA Section 4 stud ies include evaluations of developmental toxicity, repro ductive toxicity, subchronic neurotoxicity, and pharma cokinetics. ACCOMPLISHMENTS: The Panel initiated a volun tary research program to further evaluate the health ef fects of hydroquinone. Voluntary research currently in progress includes PBPK modeling and studies on epide miology, protein binding dosimetry, oxidative stress in the kidney, comparative enzymology, and in vitro metabo lism. To disseminate results of its research program, the Panel published a number of abstracts and scientific articles, and gave poster presentations at various scientific con ferences. The Panel also provided various trade groups, including the Nonprescription Drug Manufacturers As sociation, the Cosmetic Ingredient Review, and the Cos metic, Toiletry, and Fragrance Association, with summa ries and final reports of its studies. PLANS: The Panel plans to continue publishing results of its TSCA and voluntary research programs in appro priate scientific journals. The Panel also will monitor hy droquinone issues being considered by the European Union, OECD, Japan, EPA, NTP, IARC, the Food and Drug Administration, and the Nonprescription Drug Manufacturers Association. Inorganic Acid Mists Panel HISTORY: Manufacturers and users of sulfuric acid formed the Panel to address the International Agency for Research on Cancer's classification of occupational ex posure to strong inorganic acid mists, including sulfuric acid, as carcinogenic to humans. Occupational exposures to strong inorganic acid mists have occurred in a variety of occupational settings such as isopropanol and ethanol manufacturing, metal plating, steel pickling, soap manu facture, metal smelting, and cell houses. ACCOMPLISHMENTS: The Panel co-sponsored an in dependent scientific review of epidemiology studies on occupational exposure to inorganic acid mists. The re view was co-sponsored with the European Sulfuric Acid CHA 030868 A Report on the Year 1393-1994 CmCTM Association (ESA), a CEF1C Sector Group. The review targeted the human cancer studies reviewed by IARC and included more recent studies. Applicable rodent and genotoxicity data were also evaluated. A draft report has been provided to the Panel. A final report and publica tion of an article in a scientific, peer-reviewed journal are anticipated. The Panel also is supporting the development of a method for measuring airborne sulfuric acid mist levels in occu pational settings. Current methods are inadequate in that there is positive interference from particulate sulfate salts which can lead to calculations of high workplace expo sures. PLANS: Other objectives of the Panel are the develop ment of data for input into the exposure and risk assess ment process and possible participation in and conduct of additional feasibility and epidemiology studies. The Panel will monitor NIOSH's interest in the conduct of new occupational human health studies and the updating of previous studies. up studies to the Section 4 work to evaluate findings for risk assessment data. For example, an in vitro skin pen etration study as a human exposure paradigm for risk as sessment is underway. Completed studies include a 90day vapor inhalation neurotoxicity follow-up study in female Fischer 344 Rats and an alpha 2u-globulin study. Final reports have been submitted to EPA. Panel repre sentatives gave poster presentations on these two com pleted add-on studies at the Annual Meeting of the Soci ety of Toxicology in March. EPA has issued the final Significant New Alternatives Policy Rule. The Panel com mented on the proposed rule in June. The final rule clari fies that all "oxygenated organic solvents," including es ters, ethers, alcohols and ketones, are acceptable substi tutes in the following use sectors: metals cleaning; elec tronics cleaning; precision cleaning; adhesives, coatings and inks; and, aerosol solvents. Additionally, the Panel has reviewed the Section 4 test results with the Michigan Scientific Advisory Panel in a successful effort to encour age the Advisory Panel to recommend an interim Initial Threshold Screening Level for isopropanol to the Michi gan Air Toxics Commission. Isopropanol Panel HISTORY: The Panel formed to address health effects concerns about isopropanol raised by the Interagency Testing Committee in its 19th Report to the EPA Admin istrator. The Panel's objective is to collect information to aid in the assessment of health risks arising from produc tion, storage, transportation, and use of isopropanol. ACCOMPLISHMENTS: The Panel is testing isopro panol for health effects in compliance with a TSCA Sec tion 4 test rule issued in 1989. Testing requirements in clude: subchronic toxicity, reproductive toxicity, devel opmental toxicity and neurotoxicity, mutagenicity, phar macokinetics, and oncogenicity. The developmental tox icity, mutagenicity, pharmacokinetics, subchronic neuro toxicity, developmental neurotoxicity, reproductive, and 18-month mouse oncogenicity studies were completed and submitted to EPA. The final report of the two-year rat oncogenicity study will be submitted to the Agency in July. Manuscripts of all other completed studies have been submitted to peer-reviewed journals for publication. A single manuscript for the two oncogenicity studies is in preparation. The Panel is conducting several follow PLANS: The Panel will continue to conduct add-on stud ies to the TSCA test rule as well as interact with EPA on interpretation and evaluation of the Section 4 test results. Sponsorship of one additional study, an in vivo dermal absorption study in rats, is anticipated. The Panel plans a comprehensive risk assessment of isopropanol and will work with IRIS on its database. Results of all completed studies will be published in peer-reviewed journals. The Panel also plans to complete a SIDS dossier for submis sion to OECD in January 1995. The Panel will continue its efforts to impact the following issues: Design for the Environment; Michigan Air Toxics Regulations; and. the Canadian National Pollutant Release Inventory. Work with EPA to correct the TRI database for isopropanol will continue. Ketones Panel HISTORY: The Panel formed to address EPA activities on MEK, MIBK, MO, and isophorone and has recently decided to include issues relating to secondary butanol. The Panel has negotiated testing programs with EPA to supplement the data base on MO, MEK, MIBK and iso phorone. CMA 03086? CHEMSTAR A Raport on the raar 1993-1994 ACCOMPLISHMENTS: The Panel litigated against the inclusion of MIBK in the Neurotoxicity Endpoint Test Rule and worked with other litigants to negotiate a settle ment agreement with the Agency which was signed in April. After a consent agreement is signed, the Panel in tends to conduct the neurotoxicity testing program for MIBK agreed upon in the settlement. As part of a joint CMA/EPA/SOCMA pilot project, the Panel submitted information to support EPA's efforts to accurately characterize risk for chemicals under evalua tion in the Agency's Risk Management Program. In March, the Panel submitted comments in response to EPA's proposal to list wastes generated during the pro duction of carbamates as hazardous wastes. The Agency identified MEK and MIBK as constituents of concern and proposed to add MIBK to Appendix VIII of the RCRA regulation. The Panel submitted comments and devel oped a protocol for testing in response to the Interagency Testing Committee's designation of secondary butyl al cohol for dermal absorption testing. Also, the Panel, to gether with the Oxo Process Panel, has formed a Task Group to address Clean Air Act issues, such as voluntary regulatory negotiations, pending Maximum Acheivable Control Technology standards, and EPA's proposed "clus ter" rules. The Task Group has begun preparation of a "white paper" on oxygenated solvents. PLANS: The Panel will continue to address a variety of voluntary and regulatory initiatives regarding ketones. Ar eas of interest include the EPA OPPT Printing Industry Design for the Environment initiative, the Architectural and Industrial Maintenance Coatings and the Wood Fur niture regulatory negotiations. Additionally, the Panel continues to diseuss areas of mutual interest with the CEFIC Oxygenated Solvents Producers Association. LaboratoryandResearch Chemicals Panel HISTORY: The Panel formed to address issues unique to the laboratory and research chemicals industry. Panel fo cuses are: commenting on regulatory and legislative pro posals affecting the industry; advocating the interests of the industry before domestic and international organiza tions and government agencies; developing protocols and contracting for research; and, developing and sponsoring educational programs to implement objectives of the Panel. ACCOMPLISHMENTS: This former Business Council elected to become a Panel in order to expand its member ship beyond CMA member companies. The Panel then participated in the CMA-sponsored American National Standards Institute (ANSI) labelling standards process to ensure that needs of small packagers were appropriately addressed. The ANSI labelling standards revisions are nearing completion and for the first time the standards recognize small package considerations. PLANS: The Panel will continue evaluating cost-effec tive ways to help the laboratory and research chemicals industry implement Responsible Care, with particular focus on the Product Stewardship and Distribution Codes. Projects to develop input into other standards setting or ganizations and regulatory agencies on packaging and transportation issues are being initiated. Also, the Panel will provide a forum for ensuring that CMA standing com mittees develop positions and work products that reflect the special considerations of small chemical packagers. Maleic Anhydride Panel HISTORY: The Panel formed in 1993 to jointly promote the principles and practices of Responsible Care with primary emphasis on Product Stewardship. The Panel plans to accomplish this by providing health, safety and environmental information to guide maleic anhydride users and transporters. ACCOMPLISHMENTS: The Panel's immediate prior ity is to provide consensus non-proprietary information to guide maleic anhydride users and transporters. To this end, the Panel has contracted to produce two videos. The first will cover health and safety issues and the second will deal with shipping and unloading maleic anhydride. It is expected that the videos will be completed by late Summer. 1994. PLANS: The Panel is also planning to publish a compre hensive brochure that can accompany the videos. Metal Catalysts Panel HISTORY: The Panel formed to collect and evaluate in formation necessary to assess safety, environmental, and health issues for metal-containing catalysts used in in dustrial processes. The Panel originally focused on a re- D-20) Aik Me c l < t CMA 030870 A Report on the Year 1993-1994 cmiSTAK search program to characterize the toxicity profiles of metal catalysts, with particular emphasis on nickel-con taining materials. Over the last several years. Panel fo cus has changed with an increase in advocacy activities in the areas ot industrial and environmental regulatory concerns. ACCOMPLISHMENTS: The Panel continued to inter act with the ACGIH on the proposal to lower the Thresh old Limit Values for all nickel compounds to 0.05 mg/ m3. Industry commenters were successful in persuading ACGIH to keep nickel in the 'intend to change" category for another year. The Panel worked extensively with the EPA in its efforts to revise the definition of solid waste under RCRA subtitle C. Comments and discussion pa pers were submitted on several occasions, and meetings were held with EPA officials. The Panel continued to cooperate with the Nickel Producers Environmental Re search Association, the Chrome Coalition, and the Euro pean Catalysts Manufacturers Association (ECMA), through meetings and information exchange. The Panel is involved jointly with NiPERA, the Nickel Development Institute, the National Association of Metal Finishers. Inco United States. Inc., and the International Metals Reclamation Company. Inc., in litigation challeng ing EPA's National Primary Drinking Water Regulation for Nickel. As a result of the litigation, EPA has agreed to take a voluntary remand of the standard. Closure is expected in the near future. PLANS: The Panel will continue liaison with NiPERA, NiDI, ISRI. NAMF, the Chrome Coalition, and ECMA. Issues that will be of prime importance to the Panel are the nickel litigation, the EPA proposal on solid waste, and various actions under the Clean Air Act Amendments. The Panel will continue to monitor and evaluate issues of in terest to the industry, and will undertake additional projects as appropriate. Methyl Bromide Industry Panel ACCOMPLISHMENTS: The Panel continues to con duct testing to satisfy pesticide reregistration and other data call-in requirements. Testing is ongoing in numer ous areas including product chemistry, ecological effects, environmental fate, toxicology, and residue analyses. In the latter area of residue studies, the Panel completed residue analyses on almost 50 different crop commodi ties and worked with a dozen other organizations to complete work on another 20 crops. A number of food processing studies also have been completed. PLANS: The Panel will continue to fulfill pesticide data call-in requirements and will complete a dietary assessment and tolerance petition for submission to EPA in 1994. Nitrosamines Panel (Completed) HISTORY: In January of this year, the Panel officially terminated its activities. The Panel originally formed to identify and address impending federal and interna tional regulatory actions that potentially impact nitro samines. Products of interest to member companies include: rubber additives, secondary amines, cosmet ics components, soaps, detergents, and surfactants. ACCOMPLISHMENTS: In 1993 the Panel completed a chapter on N-nitrosamines in "Patty's Industrial Hy giene and Toxicology," and met with OSHA, NIOSH, EPA, and the National Safety Council (NSC) to dis cuss concerns about potential exposures in the work place. Over the years the Panel has interacted with numerous regulatory agencies to alleviate concerns about potential workplace exposure to nitrosamines. Advocacy efforts were also directed at proposed regu lations to lower levels of nitrosamines in drinking wa ter. Panel members have sponsored projects and par ticipated in seminars to better assess and communi cate information on the properties and risks of N-nitrosamine containing compounds. Olefins Panel HISTORY: The producers of ethylene and propylene formed the Panel in 1992 to conduct advocacy on en vironmental regulations from an engineering view point. Regulations on benzene and butadiene, which are inadvertently generated in the production of C, C4 olefins, were a major focus. The Panel is particu larly concerned with the regulation of olefins plants under the Clean Air Act Amendments. Because ole fins plants are intermediate between petroleum refin- -n) CMA 030971 CHCMSTAR A Report on the Year 1993-1994 ing and traditional chemical synthesis facilities in their operations, they require specifically focused regulations. diene and 4-vinylcyclohexene activities will be incorpo rated into the new Panel. ACCOMPLISHMENTS: The Panel focused on environ mental advocacy by obtaining a separate source category for olefins plants under the Clean Air Act. Based on this separation, these plants are excluded from the Hazardous Organic NESHAP which was published in March. In ad dition, the Panel commented on the ACT for control of NOx emissions from process heaters and convinced EPA to create a separate category for pyrollysis furnaces. The separate category recognizes differences in NOx emis sions and allows states to regulate emissions from pyrollysis furnaces differently from other types of indus trial furances. In addition, the Panel conducted a very successful research and advocacy program on ethylene and propylene. The program was developed and funded jointly with the So ciety of the Plastics Industry. The concern about ethyl ene and propylene was based on their metabolism to eth ylene oxide and propylene oxide, respectively. The ox ides are animal carcinogens. The Panel sponsored scien tific studies on ethylene which showed that, although a small amount of ethylene oxide was produced, ethylene was unlikely to cause cancer due to this small amount of metabolism. Based upon the Panel's research, which was presented to IARC scientists, ethylene and propylene were not designated carcinogens. The Panel began a coordination effort with the Lower Ole fins Sector Group at CEFIC. The two groups are work ing together following the IARC review to determine data needs for ethylene and propylene. In addition, the two groups are discussing coordinated advocacy efforts. The Panel merged with the Butadiene Panel to form the new Olefins Panel. The new Panel will cover advocacy and research needs for all chemicals of interest to ethyl ene manufacturing. At present these chemicals include ethylene, propylene, butadiene, and 4-vinylcyclohexene. a-Otefins Panel HISTORY: Manufacturing companies formed the Panel to collect, generate and evaluate information required to complete Screening Information Data Sets for several al pha-olefins. The SIDS information will be used for evalu ating environmental and health toxicity potentials of these chemicals. The Panel will conduct other testing as ap propriate. ACCOMPLISHMENTS: The Panel developed dossiers for 1-hexene. 1-octene, 1-decene, 1-dodecene, and 1tetradecene. The Panel also framed structure activity re lationship based-testing recommendations to fill data gaps for the series. These U.S. recommendations were ap proved by the OECD at a meeting in Paris in March 1993. The referenced chemicals are included in the second phase of the OECD High Production Volume Existing Chemi cals Voluntary Testing Program. PLANS: The Panel is awaiting the results of a reproduc tive/ developmental toxicity screening test for 1-hexene following OECD Guideline 421 and a combined repeat dose toxicity study with reproductive/developmental screening for 1-tetradecene following OECD Guideline 422. The Panel intends to sponsor an aquatic screening testing package for 1-tetradecene in the near future. Upon completion of testing and collection of exposure infor mation, the Panel plans to participate in a SIDS Assess ment Review of C6, C8, CIO, C12, and C14a-01efins. Oleylamine Panel HISTORY: The Panel formed in response to the proposed test rule for oleylamine under TSCA Section 4 requiring pharmacokinetics, genetic effects, subchronic toxicity (in cluding neurotoxicity and reproductive effects), and ter atogenicity data for this chemical. PLANS: The new Olefins Panel will reorganize to ad dress all issues of concern to the industry. An Environ mental Task Group was formed to address environmental issues, including Clean Air Act regulations. In addition, a research and advocacy plan will be developed jointly with CEFIC on ethylene and propylene. Finally, the buta ACCOMPLISHMENTS: In June 1994, the Panel re ceived information about the EPA Risk Management 1 meeting to evaluate the results of studies conducted by the Panel in fulfilling the requirements of the TSCA Sec tion 4 Test Rule for Oleylamine. The Agency's decision was to drop oleylamine from further review, based on a 0-22: A Re 0) CMA 030872 A Report on the Ytar r993-1994 CHEMSTAR low level of concern for health and environmental effects. Additionally, requirements for third-tier mutagenicity and oncogenicity testing were not implemented in light of the Agency staff's conclusions on mutagenicity tests. In September 1994, the Panel agreed to participate in the OECD Existing Chemicals Voluntary Testing Program to investigate the potential human health and environmen tal effects of oleylamine. The Panel has prepared and submitted a Screening Information Data Set dossier which includes an evaluation of existing data and an identifica tion of any data gaps. PLANS: The Panel plans to complete a toxicokinetics research project in late 1994. At the completion of this study, members will assess the data and determine the Panel's future course of action. Oxo Process Panel HISTORY: The Panel formed from a merger of the Ethylhexanoic Acid Panel, and the 2-Ethylhexanol Panel along with its Butyraldehyde Task Group. In addition to these three chemicals, the Panel-addresses issues pertain ing to ethyl and butyl acetate, amyl, butyl and isobutyl alcohols, propionaldehyde and isobutyraldehyde. This consolidated approach enables members to address issues on a broad range of chemicals that are starting materials, intermediates, or end products of the same industrial pro cess. ACCOMPLISHMENTS: The Panel litigated against in clusion of isobutyi and butyl alcohol, butyl and ethyl ac etate, and n-amyl acetate in the Neurotoxicity Endpoint Test Rule and worked with other litigants to negotiate a settlement agreement with the Agency which was signed on April 28,1994. Although the consent agreements have not yet been signed, the Oxo Process Panel has begun neurotoxocity testing on isobutyl alcohol, butyl acetate and ethyl acetate. The remainder of the neurotoxicity test ing program will be initiated after signing of the consent agreements. Due to information presented by Panel toxicologists at the March 1994 TLV Subcommittee Meeting, ACG1H agreed to postpone the decision to reduce the TLV for butyl acetate from 150 ppm to 20 ppm until March 1995. This decision was based largely on the understanding that the Panel would attempt to characterize workplace expo sure to butyl acetate. The Panel's Butyl Acetate Task Group intends to conduct air monitoring studies this Fall at six furniture manufacturers' facilities in the hopes of provid ing information to ACGIH that supports retaining the cur rent TLV. To further its proactive approach, the Panel has volun teered to prepare dossiers on a number of Oxo Process chemicals for the OECD Existing Chemicals Testing pro gram. The chemicals that have been accepted into the OECD program include butyl and isobutyl alcohols, 2ethylhexanoic acid and butyraldehyde, as well as 2ethylhexyl alcohol for which credit is being shared with Sweden. As part of a joint CMA/EPA7SOCMA pilot project, the Panel submitted information on n-butanol to support EPA's efforts to accurately characterize risk for chemicals under evaluation in the Agency's RM Program. Representatives of the Panel attended the June 1993 meeting of the North Carolina Scientific Advisory Board on Toxic Air Pollut ants to urge consideration of further information regard ing the toxicity of 1-butanol prior to setting an Acceptable Ambient Level(AAL) for the chemical. After the Panel's presentation, the Air Toxics Board agreed that a more ap propriate basis for establishing an AAL should be selected. In response to an ITC request, the Panel's Butyraldehyde Task Group submitted information on butyraldehyde con cerning the potential for worker exposure and environ mental releases. On February 24, 1994, the Panel submit ted comments to EPA in response to the Agency's pro posed test rule for health effects testing on ethyl acetate. The Panel is preparing manuscripts on the 2-EH oncoge nicity and subchronic studies for submission to peer-re view journals Finally, the Panel, together with the Ketones Panel, has formed a Task Group to address Clean Air Act Issues that impact solvents. Issues include voluntary regulatory ne gotiations, such as the Wood Furniture and the Architec tural and Industrial Maintenance initiatives, pending MACT standards and EPA's proposed "cluster" rules. The Task Group has begun preparation of a "white paper" on CMA 030873 CHCMSTM A Report on m Year 7993-1994 regulated solvent emissions and intends to interact with other associations to identify issues of common concern. PLANS: The Panel will continue to address a variety of voluntary and regulatory initiatives regarding oxo pro cess chemicals and is currently preparing for its upcom ing combined Panel and TRTG Planning Session. The Panel intends to develop a long-range strategic plan for the oxo process chemicals. Other areas of interest for the Panel include participation in the EPA OPPT Printing Industry Design for the Environment Initiative and fur ther developing a cooperative, mutually beneficial rela tionship with CEFIC's Oxygenated Solvents Producers Association in order to further develop an international approach to oxo process chemicals' advocacy. Petroleum Additives Panel HISTORY: The Panel formed to pursue research and ad vocacy interests of active developers, manufacturers or users of additives used to enhance the performance of automotive and industrial petroleum fuels or lubricants. The Panel's mission included development of a product approval protocol for engine oil testing and addressing health, regulatory, and environmental issues affecting the additives industry, ACCOMPLISHMENTS: The Health, Environmental and Regulatory Task Group, in conjunction with the Euro pean Additives Technical Committee, is conducting an aquatic toxicity research program on nineteen classes of lubricant additives. The data will be used to support Eu ropean environmental labeling requirements and U.S. regulations. The Task Group also is participating in Phase 2 of the OECD HPV Existing Chemicals Voluntary Test ing Program, specifically addressing data needs on zinc dialkyldithiophosphates. Testing will be completed and updated dossiers submitted to EPA in September 1994. Additionally, the Task Group is reviewing an EPA final rule on fuels and fuel additives registration which requires health effects testing of combustion and evaporative emis sions. Through the efforts of the Product Approval Protocol Task Group (PAPTG), the Panel developed a CMA Product Approval Code of Practice for engine oil testing that be came operational in March 1992. Registration Systems, Inc., provides industry oversight, administrative and ad visory services related to operation of the Code. RSI has registered over 8000 candidate engine oil tests. Using the submitted test reports, RSI has analyzed the results and provided periodic reports to industry on engine testing precision and accuracy. In March, five heavy-duty (diesel) engine tests were in cluded in the Code. In addition, the Task Group com pleted development of a template for introduction of new tests into the Code, and developed a procedure for proac tive analysis of the candidate database. The Task Group also completed work on a system to annually benchmark and measure engine test quality improvement, timeliness in identification and quantification of engine test prob lems, and test equipment calibration costs. These activi ties were introduced at an industry management meeting in December 1993. The Task Group has also held meet ings with U.S. and European stakeholders in the testing, licensing and certification process. Another major event was the introduction of engine test ing laboratories into the Code compliance process. Ten laboratories committed to conduct all CMA-scheduled engine tests according to those practices of the Code for which the test laboratories are responsible. This includes calibration and assignment of engine test stands, test reg istration, and reporting of test results to the CMA Moni toring Agency, Also in the compliance area, fifteen test sponsors successfully completed their first year of Code practice by completing an audit and submitting the re sults to CMA. All fifteen companies were found to be in compliance. The Fuels Detergent Performance (FDP) Task Group re sponded to the proposed Clean Air Act Section 211(1) rule making, which was issued in December 1993. Dr. Alan Millard, FDPTask Group chairman, testified at EPA's pub lic hearing on the rulemaking on January 11, 1994. In addition, the Task Group submitted extensive written com ments on the rulemaking on February 11, 1994. Overall, the Task Group agreed with the broad outlines of a per formance-based self-certification system, as proposed in the rulemaking, but noted several aspects of the rule which could be revised for a more practical and cost effective regulation, without sacrificing air quality benefits. In par ticular. the Task Group disagreed with the proposed fourfuel test matrix approach, and with API's concurrence, -.uggested the option of testing a single fuel that meets 0-24 AR Ph CHA 030874 A Report on the Yoor 1933- 1934 CKMSTAB specific seventy parameters. The Task Group and API also supported a single-tier certification system, rather than the two-tier system outlined by the Agency. To re spond to EPA's concern with the potentiality of underadditized gasoline, the Task Group co-sponsored a project with API to investigate vanations in fuel seventy param eters on deposit formations. Finally, in its comments, the Task Group noted that EPA should not purport to make detergent manufacturers "presumptively liable" for down stream violations. PLANS: The HERTG will decide if the testing require ments for fuel/fuel additives registration can be met by an industry testing consortium. Coordination with the American Petroleum Institute on this issue is anticipated. The current voluntary testing programs are expected to be completed by year end, at which time the Task Group will assess further testing needs. The PAPTG and its work groups and advisory groups will continue involvement in activities related to the Code of Practice operation. Work in progress includes benchmark ing of the Code, proactive analyses of the database on candidate oils (pilot program), and third-party auditing of company and test laboratory compliance during the second year of Code operation. Using the Code template as a model, the group will continue to meet with industry stakeholders both in the U.S. and abroad to advocate im provement in test development and improved test preci sion and accuracy. The FDP Task Group will await the final Section 211(1) rulemaking, which is scheduled to be issued by October 15, 1994. -Phenol Panel Regulatory HISTORY: The Phenol Regulatory Task Group formed to address regulatory, toxicology, and environmental is sues concerning phenol. During the past year. Regula tory Task Group efforts have focused on voluntary re search and regulatory advocacy. ACCOMPLISHMENTS: A voluntary pharmacokinet ics study sponsored by the Regulatory Task Group was completed. Results supported the conclusion that oral toxicity data on phenol may be used to extrapolate to the inhalation route of exposure. The final study report was submitted to EPA. The Agency will use the pharmacoki netic study to decide if inhalation testing of phenol is nec essary. The Regulatory Task Group is waiting for EPA's decision, EPA listed phenol as a proposed regulated substance un der the accidental release provisions of the Clean Air Act Section 112(r). The Regulatory Task Group subsequently submitted technical comments resulting in removal of phe nol from the final 112(r) list. In response to a proposal by the Ontario Ministry of Labour to lower the occupa tional exposure limit of phenol in Canada to t ppm, the Regulatory Task Group submitted safety data to the Ca nadian government supporting a 5 ppm limit. The Regu latory Task Group is waiting for a response on its com ments from Canadian officials. In response to EPA Re gion V listing phenol as a "bioaccumulative chemical of concern" in its Water Quality Guidance for the Great Lakes, the Regulatory Task Group submitted comments indicating phenol is inappropriately listed because phe nol does not persist in the aquatic environment and does not bioaccumulate. The Regulatory Task Group is wait ing for a response from EPA Region V on its request to delist phenol. EPA issued a proposed TSCA Section 4 test rule on phe nol. The Regulatory Task Group responded by submit ting comments stating that existing data on phenol makes much of the Agency's proposed testing unnecessary. As a cost-effective alternative to the extensive health effects testing program required by EPA in the proposed test rule, the Regulatory Task Group proposed a tiered testing ap proach that would address all of the Agency's data needs. The Regulatory Task Group is waiting for EPA to set a date to begin TSCA Section 4 consent agreement nego tiations. PLANS: The Regulatory Task Group plans to: prepare for its TSCA Section 4 consent agreement negotiations with EPA; address a proposed EPA HAPs TSCA test rule requiring acute inhalation data; and, respond to the list ing of phenol as a targeted substance under the Automo tive Pollution Prevention Program. The Regulatory Task Group is considering sponsorship of a study on the treat ment of phenol bums. The Regulatory Task Group also intends to publish its pharmacokinetic study in a scien tific, peer-reviewed journal. o-ai CMA 030875 CHEMSTM A Report on the Year 1933-1994 Phenol Panel Safety HISTORY: The Panel formed to promote greater safety in the production, transportation and use of phenol. Mem ber companies exchange non-proprietary safetv informa tion on transportation and handling issues. Education is sues are the focus of the Video Task Group, which is tar geting worker and customer safety. ACCOMPLISHMENTS: The Panel completed work on a self-contained training program on how to safely handle and transport phenol. The training program includes in structor and student workbooks, along with two separate instructional videotapes. The program targets custom ers. transporters, plant personnel and other downstream users and emphasizes first aid measures, personal protec ts e equipment, emergency response, plant handling and unloading procedures and precautions. The Panel completed the fourth annual member company self-assessment of worker safety and environmental per formance in phenol-producing plants. The Panel devel oped Pro-Active Safety Index was the tool used to com plete the self-assessment. At the awards ceremony in Oc tober, Georgia Gulf Corporation was recognized as both the industry leader and most improved for their record at their Pasadena. Texas facility. This years index was ex panded to include environmental factors along with worker safety in the evaluation, PLANS: The Panel will sponsor a customer safety semi nar in 1994-1995. Phosgene Panel HISTORY: The Panel formed to improve the industry's ability to safely manufacture, handle, and use phosgene. Predicting and controlling ambient concentrations of phosgene from accidental releases is an important Panel objective. ACCOMPLISHMENTS: The Panel completed the Bul letin on Phosgene Pulmonary Exposure Information. The basis of the bulletin was the research findings from the New York Medical College phosgene countermeasure research. The bulletin was provided to all Panel member medical staff. The Panel continued to sponsor studies in phosgene air dispersion modeling and mitigation. Most recently the phosgene mass coefficient was determined by the Panel; this coefficient will be used in the phosgene air dispersion model. The Panel examined several rules dealing with phosgene: The Protection of Stratospheric Ozone Rule and Listing 40CFR82; The Enhanced Moni toring Rule 40 CFR. part 5.1: and an English proposal to lower the TWA for phosgene in Europe to .02 ppm. The Panel continued to have special topic discussions on phos gene stewardship. Also the Panel reviewed several pub lications on phosgene safety and phosgene hazard/toxicity. PLANS: The Panel will continue its regular program of nonproprietary information exchanges among member companies on safety techniques. In addition, the Panel will continue monitoring increasing regulatory interest in phosgene. Modelling and mitigation work may con tinue into 1995. The Panel will continue to identify and explore additional health research projects on phosgene. The Panel at its recent Planning Meeting decided to reor ganize. The Panel added a new task group on Safety Prac tices and Guidelines to its present three existing task groups. The Panel wishes in 1995 to begin investigating how to establish safety practices and guidelines for phos gene manufacturing. Phthalate Esters Panel HISTORY: The Panel formed in 1972 to address envi ronmental issues. In 1976, the Interagency Testing Com mittee listed the alkyl phthalate category for test rule de velopment under TSCA Section 4. The ITC also included health effects testing as a concern following the release by National Toxicology Program of bioassay results on DEHP and di-2-ethylhexyl 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 sub mitted to the Agency along with a proposal for further environmental testing. In 1988, the Panel and EPA agreed on an environmental testing program under a consent or der. The testing was completed in 1991 and formally ac cepted by EPA in 1992. ACCOMPLISHMENTS: The Panel has worked with EPA to develop a sediment toxicity work plan that will assess phthalate esters as a class. EPA has worked with the Panel to refine the work plan and will conduct a por tion of the testing. D-H) A F CMA 030S76 A Report on tho Year 1993-1994 CHEMT/m Based on comments submitted by the Panel, di-n-octyl phthalate was removed from Arizona's list ot Hazardous Air Pollutants The Panel also commented on the HON resulting in EPA's decision to drop phthalate esters from the Synthetic Organic Chemical Manufacturers Industry category. It will instead regulate phthalate ester produc tion under the Phthalate Plasticizers category which is not scheduled for Maximum Acheivable Control Tech nology development until the end of the decade. The Panel had a productive year working on a wide vari ety of needs and responding to many diverse requests. Data from Panel-sponsored environmental effects testing has been prepared for publication in peer reviewed jour nals. Panel members critiqued Chemical Product Safety Cards for the World Health Organization. Posters were presented at the SETAC meeting in Houston and at SETAC Europe, Panel comments were submitted on the Great Lakes Initiative, the ATSDR Toxicological Profile on di ethyl phthalate, and the Texas Hazardous Waste Identifi cation Rule. The Panel challenged an article implying that DEHP has a hazard equivalent to that of PCBs when it is used as a dielectric fluid in lighting ballasts. As a result of the Panel's comments, the article was substan tially rewritten. PLANS: The Panel plans to work with CEFIC's Euro pean Council for Plasticisers and Intermediates to coor dinate testing and publication programs to foster harmo nization and reduce costs. The Panel will continue to provide input to NTP on a testing program it is designing which will include dibutyl phthalate. The Panel will start the in-lab portion of the sediment toxicity testing pro gram and make preparations for Phase II testing. A peti tion will be prepared and submitted to EPA requesting that DEHA be delisted from SARA 313. Polychlorinated Biphenyls Panel HISTORY: The Panel was formed to represent the inter ests of the industry during implementation of the TSCA Section 6 regulations for PCBs. Regulations evolved covering spills and disposal of PCBs, mitigation of trans former fires, the inadvertant generation of PCBs. and op eration of electrical equipment containing PCBs. ACCOMPLISHMENTS: The Panel continued its col laboration with the National Electrical Manufacturers As sociation and the Edison Electric Institute's Utility Solid Waste Activities Group as part of the PCB Industry Con sensus Group (ICG). The Industry Coalition pressed EPA to publish a proposed rulemaking to expedite PCB dis posal through more flexible and consistent rules. The Coalition continues to advocate presumptive numbers for the cleanup of old spills and withdrawal of the PCB anti dilution provisions of TSCA. The Coalition also reviewed the information on PCBs contained in the EPA IRIS data base and submitted additional information to IRIS. The Coalition supported presentation of its funded study of declining trends of PCBs in the environment and filed comments on EPA's proposed water quality guidance for the Great Lakes. The PCB Coalition dedicated a meeting in January for a strategy and planning session that included a historical and future review. PLANS: The Panel and the other members of the Indus try Coalition will implement its strategic plan and con tinue to focus on the progress of EPA's proposed disposal rulemaking and coordinate approaches to new EPA PCB cleanup rules. The Coalition will persist in its position that PCB disposal should continue to be governed by TSCA. The Coalition will follow-up on the comments submitted and activities surrounding the Great Lakes water quality and is planning comments on the EPA sediment quality criteria. The Panel will follow developments sur rounding the use of Toxicity Equivalency Factors (TEQ) by EPA. TEQ, originally suggested as a screening tool, is being applied to PCBs and other chemicals as a regula tory device at both the state and federal levels. The Panel filed comments as early as 1991 cautioning EPA about the limitations of applying TEQ in a regulatory frame work. Propylene Glycol Ethers Panel HISTORY: Manufacturers of propylene glycol ethers or ganized as a Panel to explore interest in a shared research program and work with government organizations inter ested in these materials. d-2i; CMA 030377 CHEMSTM A Report on tho loot 1993-1994 ACCOMPLISHMENTS: Responding to a TSCA Inter agency Testing Committee report, manufacturers of propvlene-based glycol ethers have established a working relationship with the ITC to clarify testing interests. The Panel sought and received a stay of the corresponding TSCA Section 8(a) and 8(d) reporting rules while the is sues are getting clarified. Liaison with the National Toxi cology Program has also been established to share infor mation on testing programs. The Panel successfully kept propylene glycol ethers out of both a California legisla tive initiative and an Arizona air regulation. Both situa tions involved confusion with the definitions and scien tific data for propylene glycol ethers. The Panel shared toxicology information with a Califomia-OSHA Advisory Board as they set priorities for occupational standard set ting. PLANS: The Panel plans to complete a toxicology re view and initiate a voluntary research program over the next year. They will continue to monitor and respond to government proposals at both a federal and state level. Propylene Oxide Panel MISSION: Manufacturers of propylene oxide organized as a Panel to improve emergency response, handling and transportation of propylene oxide and to address advo cacy issues such as reevaluation of workplace exposure limits and carcinogenicity potential. The Panel established the Emergency Response and Marine Transportation Task Groups to assess the emergency response needs and ca pabilities of the industry with emphasis on marine distri bution, ACCOMPLISHMENTS: The Panel sponsored an ob server to IARC workgroup meetings in February where the classification of propylene oxide was under review. As a result of the meetings, the current classification of propylene oxide was not changed. Panel task groups be gan to address safety and handling procedures related to manne transporation, and to assess U.S. emergency re sponse capabilities. PLANS: The Panel will continue to address safety and handling issues, and will further consider developing an emergency response network. The Panel plans to estab lish working relations with the European Propylene Ox ide Panel through information exchange. Panel mem bers will, as appropriate, monitor and evaluate research of interest to the industry as well as work with regulatory agencies and other concerned organizations in matters relating to propylene oxide. Rubber Additives Panel HISTORY: The Panel formed to support research that would expand the rubber additives safety and health is sues data base. To date, the Panel has collected informa tion on approximately 65 chemicals classified as rubber additives, and has sponsored more than S800.000 in re search. ACCOMPLISHMENTS: The Panel continued to coop erate with the EPA in its Risk Management review of 2mercaptobenzothiazole (MBT) through conversations with the RM1 project manager and members of the risk management team, and through submission of exposure and use information. The Panel submitted comments to the EPA on the proposed addition of MBT to the EPCRA Section 313 Toxics Release Inventory, and monitored MBT issues in Canada and Europe. PLANS: The Panel will continue to cooperate with the EPA in its review of 2-MBT, and will address environ mental issues and undertake additional projects as appro priate. Sodium Bromide Panel HISTORY: The Panel formed to address health, envi ronmental, and regulatory issues relating to sodium bro mide. Research has been the primary focus of the Panel. ACCOMPLISHMENTS: The Panel undertook no new activities this year. In 1990, the Panel initiated a volun tary study to evaluate the relative toxicities of bromine chloride and chlorine on various freshwater and saltwa ter species. The final study report was completed and submitted to EPA in 1991. EPA is using results of the aquatic toxicity research to develop water quality criteria for controlling discharges to water from facilities that use activated sodium bromide or bromine chloride as treat ment chemicals. 0`Zi) 5 Ti CMA 030878 A Report on the Year 1993-1994 CHEMSTM PLANS: The Panel will monitor pertinent research con ducted by organizations outside of CM A. The Panel also will interact closely on sodium bromide issues with inter ested organizations and agencies, such as the Utility Wa ter Act Group and the EPA Office of Water. PLANS: The Panel will submit data to EPA on DMT as part of a voluntary CMA, SOCMA, EPA program on ex posure assessment. In addition, the Panel is awaiting the final test rule for TPA. The Panel will await development of a SIDS dossier on DMT by Italy and monitor the re view process. Specialty Acrylates/Methacrylates Panel HISTORY: The Panel formed to address EPA concerns about new and existing specialty acrylates and methacry lates. The Panel's major emphasis is on working with the Agency to remove restrictions on the development and marketing of new products. Panel membership consists of producers, importers, formulators. and users of these chemicals. ACCOMPLISHMENTS: The Panel has completed Phase l of its research program. The dermal bioassay is com plete. and the Panel is expecting a draft report by mid1995. EPA has published a proposed generic Significant New Use Rule for acrylates as a class. The Panel com mented on the proposed rule and awaits publication of the final rule. PLANS: Once the results of the dermal bioassay are avail able. the Panel will evaluate the need for further testing. Discussions will be held with EPA to ensure that the goals of the research program have been met. The Panel also will continue efforts with EPA to remove distribution re strictions on important new chemical products in this cat egory. Terephthalates Panel HISTORY: The Panel originally formed as a task group of the Trimellitates Panel to address the petition to delist terephthalic acid from the EPCRA 313 list. A test rule proposal on TPA and Interagency Testing Committee list ing of dimethyl terephthate (DMT) caused the producers to form the Terephthalates Panel, The mission of the Panel is to address research and advocacy issues on chemicals of interest to the Panel. ACCOMPLISHMENTS: Based on Panel comments, EPA deleted DMTs from the ITC list for test rule devel opment under TSCA Section 4, because these chemicals are covered by the OECD Voluntary Testing Program. Titanium Dioxide Panel HISTORY: The Panel formed in 1977 to address toxi cology and occupational issues associated with TiO, and its manufacture. ACCOMPLISHMENTS: During the past several years, the Panel submitted scientific data to NIOSH supporting the safety of titanium dioxide (TiO,). This submission was in response to NIOSH classifiying TiO, as a poten tial occupational carcinogen. The Panel's position is that TiO, is not a carcinogen, which is consistent with deter minations made by ACGIH, EPA. FDA. and IARC, as well as by an independent, international group of expert pathologists. This past year, the Panel sponsored volun tary research to evaluate the potential pulmonary effects of TiO,. The research was undertaken by the Panel to support its continuing advocacy efforts with NIOSH. During the past year, the Panel completed development of a new air dispersion model for titanium tetrachloride (TiCl4). Compared to older air dispersion models, the Panel's new software model more adequately predicts downwind dispersion and concentrations of TiCl4. Also in contrast to older air dispersion models, the new model can track dispersion of secondary reaction products. As part of the model development effort, a scientific back ground document and user-trainer manual were prepared. An international workshop of U.S.. Canadian, and Euro pean producers was held to train users on the new model. As in past years, the Panel continued to hold informa tion-sharing sessions in which member company repre sentatives discussed case histories of accidental releases and safety problems encountered with TiClv By sharing incident experiences, the Panel hopes to enhance worker and community safety. PLANS: The Panel's plans include: meeting with NIOSH to discuss Panel sponsored research: providing scientific data to NIOSH, OSHA, ACGIH, other interested orgam- o-zi) CMA 030879 CHEMSTM A Report on the Year 1393-1394 zations; participating in symposia on lung clearance mechanisms; voluntarily sponsoring and publishing stud ies on the potential health effects of TiO,: advocating an upward adjustment in the RQ for TiClt; monitoring CEFIC'S TiO, Sector Group; and, developing advocacy positions on proposed regulations. Toluenediamines Panel HISTORY; A Toluenediamines Panel was formed in 1980 to address an EPA Advance Notice of Proposed Rulemak ing on Phenylenediamines, including toluenediamines. EPA recommended carcinogenicity testing for TDA, but later in the rulemaking decided that testing was not re quired. Ultimately, EPA. under the authority granted by TSCA Section 9, referred the matter to OSHA for pos sible regulation. OSHA did not initiate rulemaking on TDA and, in the absence of other interests, the Panel ter minated in 1987. In 1991, EPA published the proposed end-point rule requiring testing for developmental and reproductive toxicity. 2,4-Toluenediamine was among the chemicals included in the proposed rule. The Panel was reactivated by manufacturers to address this rule. ACCOMPLISHMENTS: During 1991, the Panel devel oped chemical-specific comments which were transmit ted to EPA in response to the proposed end-point rule under TSCA Section 4 requiring testing for developmen tal and reproductive toxicity. Additionally, the Panel par ticipated in the EPA public meeting on the proposed rule. The Panel has since remained dormant pending issuance of the final rule. PLANS; Upon issuance of the final test rule, the Panel will work with EPA and conduct testing as required. Total Quality Council ACCOMPLISHMENTS: In February, the Council re leased the first of several documents developed as part of a joint project with CMA's Environment, Health, Safety & Engineering Committee. "Integrating Process Safety, Total Quality: A Matrix" depicts in graphic form the con nections between the 22 elements of the Responsible Care Process Safety Code, elements of ISO 9000, the Malcolm Baldrige National Quality Award, the OSHA Process Safety Management regulation 29 CFR 1910, and the Council's "Criteria for Continuous Improvement." Aimed at plant managers, the "Matrix'' shows how ac tivities begun in support of one initiative can satisfy re quirements of others. This will help avoid overlapping efforts and allow for management of all continuous im provement activity as a single, logical process. The "Ma trix" is in its second printing and will serve as a model for similar efforts on the other five Responsible Care codes. In March, CMA began to train staff and Committee lead ers in effective meeting management. This activity, strongly supported by the Council's CMA Support Group, seeks to improve the value of member participation in association activities by making the many committee, task group, etc. meetings more efficient and effective. In April, four years of work by the Council, other indus try leaders, standard setting organizations and the Gov ernment resulted in NIST establishing the National Vol untary Conformity Assessment Systems Evaluation pro gram. NVCASE will provide a basis for the U.S. Gov ernment to assure foreign governments that qualified U.S. conformity assessment bodies are competent to satisfy foreign regulatory requirements. Council action centered on preventing government duplication of efforts already underway in the private sector. Establishment of NVCASE reflects the importance of conformity assess ment activities to international trade efforts aimed at im proving access for U.S. goods and services to foreign mar kets. PLANS: The Council is increasing its support of CMA's implementation of a Quality Improvement Process through a number of projects. The Council will become more actively involved in promoting the U.S. voluntary standards system and will support development of internauonal environmental management standards using qual ity concepts. In addition, the Council will intensify ef forts to promote the use of total quality management methods to implement Responsible Care. Tris(chloroalkyl)phosphates Panel HISTORY: Manufacturers of tris(l-chloro-2propyljphosphate (TCIP) formed the Panel to collect, gen erate and evaluate information required to complete a SIDS dossier. The Panel is compiling the dossier to as- CMA 030880 4 Riparian (hi fur 1933-1994 CHCMSTMI sess environmental and health toxicity potentials of the TCIP, and will perform any toxicity testing required as part of this effort. ACCOMPLISHMENTS: The Panel has developed a Screening Information Data Set (SIDS) Dossier of avail able data on TCIP. Members have presented this infor mation to the U S. Environmental Protection Agency, the agency responsible for implementing the OECD High Pro duction Volume Existing Chemicals Voluntary Testing Program in the U.S.. and have proposed to further evalu ate specific ecological and reproductive toxicity endpoints not addressed in the available studies. TCfP is among the 62 chemicals assigned to Phase 3 of the OECD Program. The chemical had been previously listed with Intent-toDesignate by the Interagency Testing Committee and is the subject of reporting under TSCA Section 8(d). PLANS: Consistent with informal recommendations re ceived following the review of the SIDS Dossiers for Phase 3 chemicals at the September 1993 OECD Meet ing in Paris, the Panel plans to initiate a one-generation developmental screening test program (OECD Guideline 415) to complete the SIDS datagaps. The Panel will con tinue to work with the U.S. EPA to ensure that all avail able data are identified for consideration in voluntary and regulatory programs under OECD and TSCA. -Vinyl Chloride Panel Health ACCOMPLISHMENTS: In August, the Panel commis sioned CanTox Inc. to review the Priority Data Needs for Vinyl Chloride identified by the Agency for Toxic Sub stances and Disease Registry. The CanTox report con cluded that the potential hazards associated with vinyl chloride are well known and that further testing needs identified by ATSDR would not contribute any signifi cant new information to the toxicological database on the chemical. The Panel will use the CanTox report in its discussion with ATSDR and EPA on the need for addi tional testing. Also in August, the American Journal ofIndustrial Medi cine published the Panel's concerns about the 1991 pub lication entitled, "An Industry-Wide Epidemiologic Study of Vinyl Chloride Workers," by Wong et. al. These con cerns included the reporting of excess mortality due to brain cancer and emphysema in the Wong et. al. publica tion without a discussion of other factors that may affect the evaluation of these findings. Dr. Wong agreed with the Panel's concerns and published an article in the same journal indicating that the concerns raised by the Panel were not only important for the vinyl chloride epidemiol ogy study but also for occupational epidemiologic stud ies in general. In May. The Panel invited Dr. Richard Reitz, a consult ant, to present a seminar on predicting cancer risk from vinyl chloride exposure with a physiologically-based phar macokinetic (PB-PK) model. The risk assessment based on the PB-PK model predicted considerably fewer risks than would be calculated by non-pharmacokinetic proce dures. The Panel plans to meet with EPA to discuss the risk assessment of vinyl chloride using PB-PK and multi stage modeling before the Agency develops a risk num ber for vinyl chloride in the Integrated Risk Information System database. -Vinyl Chloride Panel Transportation HISTORY: The Panel was formed in 1971 by vinyl chlo ride manufacturers to develop and assess health and safety data on vinyl chloride monomer. The Panel expanded its scope of activities in 1991 to address safety issues in the transportation of vinyl chloride monomer. In 1992, the Panel formed the Vinyl Chloride Transportation Network to provide technical expertise and assistance by the in dustry and contractors to emergency responders at vinyl chloride railroad transportation incidents. Shippers of vinyl chloride are able to activate the network through CHEMTREC, CMA's hazardous materials hotline. VCNet is the first mutual-aid network to be formed under CHEMSTAR. ACCOMPLISHMENTS: In September, VCNet updated an Emergency Response Operation Manual to facilitate the operation of the mutual aid network among CHEMTREC, vinyl chloride manufacturers and users, "for-hire" contractors, and railroad emergency response teams. CMA 030881 CHCMSTM A Report on the Year 1993-1994 Abo in December, CHEMTREC conducted a VCNet emergency response drill to test the operation of VCNet. The drill demonstrated that VCNet can be successfully activated in case of an emergency involving vinyl chlo ride. Panel members, on a periodic basis, shared non-propri etary safe-handling and distribution incident information on vinyl chloride to promote safety and to protect envi ronmental quality during manufacturing and distribution. PLANS: VCNet will identify additional ''for-hire" con tractors to provide emergency response services when the shipper cannot be contacted by CHEMTREC or when the shipper cannot reach the incident site quickly. VCNet will continue to conduct periodic mock emergency re sponse exercises to ensure that CHEMTREC, "for-hire" contractor response teams, and company response teams are aligned and can act quickly in case of an emergency. The Panel will work with CMA's Interindustry Rail Group to recommend to the American Railroad Association that future vinyl chloride railcars be constructed in a manner that would make them adaptable to a capping kit. The Panel will continue its technical support for the Vinyl Chloride Safety Awareness Training Workshops to be held throughout the U.S. The Panel will prepare a media com munication brochure for VCNet and a video on the safe handling of vinyl chloride. Vinylidene Chloride Panel HISTORY: 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 the manufacture, handling, and use of the chemical, as well as the safety of commu nities surrounding production facilities. ACCOMPLISHMENTS: The Panel tracked the Califor nia Air Resources Board Compound Review for VDC, contained in CARB's Assessment of Indoor Concentra tions, Indoor Sources, and Source Emissions of Selected Volatile Organic Compounds. CARB did not include VDC in its recommendation for further research. WaterAdditives Panel HISTORY: The Panel formed to address regulations of direct and indirect potable water additives. The objec tives are to monitor regulatory policies, improve com munication, review toxicology data, develop advocacy positions, ensure that any water additives program is de signed 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. ACCOMPLISHMENTS: The Panel continued to work with the National Sanitation Foundation (NSF) in an ef fort to have NSF accept the water additives certification packages for the following chemicals: polydiailyldimethylammonium chloride (PDADMAC). copolymers of epichlorohydrin and dimethyfamine (EPI/ DMA), and polyacrylamide (PAM). The Spring of 1994. after several meetings with NSF and addressing many is sues. the certification packages were finally accepted. Two companies have now used these certification packages along with their own company application to receive NSF certification for one water additive. Other Panel member companies are also seeking this certification. Eventually all Panel members will have their own water additives certified by NSF and the accepted certification packages will be used to benefit each Panel member. The data in the certification packages is confidential and is to be used only for the certifications of Panel members. The data is compensable and can be purchased by non-Panel mem bers. PLANS: The Panel and Panel members will continue to work with NSF to receive water additives certification for all three chemistries. At their Spring 1994 Planning Meeting, the Panel identified a value in continuing the Panel after NSF certification. The Panel will continue to monitor water additive regulations world-wide, share in formation, be a forum to address other generic polyelec trolyte issues, maintain a centralized data compensation agents, and develop joint data on other water additive chemistries. PLANS: The Panel will continue to respond to potential regulations affecting vinylidene chloride. D-32 CMA 030882 The CHEMSTAR Mission CHEMSTAR will prov ide technical and management services to facilitate chemi cal industry coalitions of all types within the Responsible Care framework. We will add value to customers' efforts in: Advocacy ... by managing advocacy efforts so that customers can promote and defend their needs in a credible and ethical manner, integrated with CMA and other consensus industry policies and practices; Research ... by managing research projects to ensure the development of the highest quality information on health, safety, economics and the environ ment, and by serving as a technical resource; Education ... by managing the development of forums and materials in a variety of media for customers use in educating employees, government officials, academia, other industry organizations, and the public; Communication ... by managing the development and dissemination of mes sages that aid the understanding of customers' products and positions; Evaluation ... by managing the development and dissemination of industry benchmarkig tools; Litigation ... by providing a last-resort mechanism for cost-effective, indus try-supported resolution of contentious issues; and. Responsible Care ... by facilitating customers' development and imple mentation of Responsible Care programs.