Document J3n4BjpQdk78M2LQak3eddjQv
1CHEMSTAR
-- t HI HI CAL SELF f UIO10 HCKlicAL ADVOCACY AID R E St A R C H
A REPORT ON THE YEAR 1989-1990
CMA 030610
CONTENTS
Chairman's Remarks .............................................. / President's Overview ............................................... 2 The Business Councils............................................. 4 New Panels ...............................................................6 Continuing Panels ...................................................8 Completed Panels...................................................26 Financial Resources............................................... 28 Regulatory Affairs .................................................30 Research.................................................................. 32 Guidance ................................................................ 33 Management Services.............................................34
CMA 030611
CHAIRMAN'S REMARKS
HEMSTAR Panels now operate in diverse u ays to accomplish their goals. Efforts include three t response
Cto proposed or existing regulations: generation of research data to support regulators- positions; and. prom me sharing of safets techniques and education ofcompany personnel on safe handling, transport and storage of chemicals. This disersiry reflects a positive evolution from the original single-fin us concept of the panels to their ini-rent status as umiples organizations fulfilling many different needs of out industry.
The CHEMSTAR Business Councils -- a new tvpe of organization -- expand even further the scope of self-funded activities under the CMA umbrella. Distinct from the panels, which focus on specific chemical product concerns, the Councils are forums for companies to share information and de velop consistent approaches to business efficiencv improvements. As the Councils crow in number and focus, they should prov ide an excellent complement to the constructive activities of our companies ongo ing in the Panels and Standing Committees of CMA.
Impacts of the CHEMSTAR organizations are visible in a significantly growing group of improved regulatory situations and coop erative relationships with companies, and other industries m the US and abroad. The financial benefits that the organizations bring to our companies deserve notice and appre ciation. Our interests will continue to be served well by placing high priority on our awareness, recognition and commitment to active participation in CHEMSTAR activi ties.
E.illicit U Dl'ill L'lipnl t. Eionihtn Choiuntl Cmiipain Clniii mini, LHEXtSTAR Pi-Iu v Cummittcv
1
CMA 030612
PRESIDENT'S OVERVIEW
m he past decade was a rime of tremendous expansion for CHEMSTAR. During I9S9-90 the number of Panels X erew to a raortl-luyli of 51. Proliferation of research and advocacy projects accentuated the need for companies to inordinate their participation in division activities, and the CHE.VfSTAR Contacts were estab lished. Em iniiu new ventures -- Business Councils -- were developed as a forum for addressing business-related ias opposed to cliemii ai-spci ifio issues. And CHEMSTAR continued to develop an international flavor as i ompames from around the world sought to join or emulate programs initiated hv the Panels and Councils.
Helping the chemical industry stay \ table in the face of mounting regulations, and furthering the industry's emphasis on safet>, are goals of the CHEMSTAR groups. Panels save industry money by negotiating yyith agencies to eliminate unnecessary testing requirements and re porting burdens They also continue to be successful m negotiating appropriate testing programs. During the past year, the Bi ocides Panel yyas able to convince EPA that a consolidated approach to chrome and ar senic pesticide ey uluution. centered on in dividual testing of chromic acid and arse nic acid, would satisfy all outstanding data dey elopment needs. This is expected to save industry a minimum of So million. In De cember, the PCB Panel achieved a signifi cant victory when EPA issued a new noti fication and manifesting rule for handling PCB wastes underTSCA. This rule was ad vocated by the PCB Coalition as an alter native to a Congressional proposal to move esponsibilitv tor regulating the storage and disposal ot PCBs under RCRA. The shift to RCRA would have been costly to tndustry for compliance and cleanup. However, the EPA rule, while tightening government control over PCB wastes, will not cause a mu|or change in chemical industry prac tices. These advocacy activities consume a significant portion of panel resources (ftdT of time. 40C ot money). In all. CHEM STAR panels made 359 submissions to gov ernment agencies in I9S9-90 -- a 61r/r increase over the previous year.
Complementing the Panels, the new Busi ness Councils are designed to help the chemical industry in a different way. Through coordination with the ongoing duest'unded activ ities ot the Association, the coun cils give the industry a valuable capability to pursue specialized business interests while maintaining coordination, consistency, and efficiency across the broad spectrum of the industry 's issues and interests. The first council, on Total Quality, will help compa nies become more quality conscious and efficient. Other councils, with projects rang ing from improving internal quality audit and communication procedures to eliminat ing duplication ot effort on supplier and carrier audits, are anticipated.
More than ever, workshops and sympo sia were economical means of sharing in formation. The audiences included com pany personnel, agency officials and scien tists from a variety of disciplines. In No vember, the Crystalline Silica Panel held a workshop to discuss the preliminary results of an independent review of studies on the crystalline silica/lung cancer issue. In addition to the academicians. 100 industry representatives attended. Also in Novem ber. the Chlorine Dioxide Panel cospon sored a very successful international sym posium with EPA and the American Water Works Association Research Foundation. The sy mposium raised the aw areness of the 250 participants to the importance ot chlo rine dioxide tor the disinfection of potable drinking water in the L S. This symposium
CMA 0306X3
2
also caused ERA to ieus-.ess it-- original po sition on hanmna some uses ot chlorine dioxide. In addition, us a result ot it' annual Safety Seminars, the Hydrogen Fluoride Panel is developing several task groups to conduct more in-depth rev tevvs ot such top ics as protective clothing transportation, and sate storage systems
'Di\ersihc'd" became a word to describe CHEMSTAR activities during 1989-90, With the formation of the first Business Council -- Total Quality -- CHEMSTAR became the focus for an industry-vv tde initiate e to tmprov e the quality of goods and 'ere ices.
During 1989*90, cooperative efforts be tween CHEMSTAR and other parts of the Association increased. The Total Quality Council teamed with the Engineer ing and Operations Committee and the International Affairs Committee to prepare comments and testimony on the LS Gov ernment's role in the voluntary standards process. The Trimellttate Esters Panel and the Environmental Management Commit tee's Reporting Issues Task Group filed joint comments on proposals todehstterephthalic acid from SARA Section 313. In addition. Panel and Council representatives are lend ing their expertise to the development of several Responsible Care Codes, most notably those on Product Stewardship and Distribution.
Cooperative efforts between Panels have also become more common, in October, the 2-Ethy Ihexanol. isopmpanol.and PhthaI ate Esters Panels submitted joint comments to EPA on the Interim Pinal Rule on Pro cedures Governing Testing Consent Agree ments and Test Rules. In addition, the similai its ot their issues vv ill result in the merger ot the Ethy Ihesanoic Acid and 2-Ethylhexunol Panels into the Oso Process Panel early nest year.
The complexity ot some issues could, how ever. lead to the formation of segmented or separate Panels to handle specific topics. Members ot the Lubricant Additives Panel are considering establishing a separate group m consider engine testing criteria, and some i uhber additives and alkanolntmnes produc ers may form a panel to address mtrosami lives.
Companies, legislators, and regulators around the world continue to emphasize environmental concerns. Interest in the development of a cradle-to-grave environ mental management philosophy is increas ing. Individual states m the LS are exer cising their sovereignty in a Hurry of leg islation designed to be more restrictive than Federal laws. Internationally, the establish ment of a unified European market is ex pected by 1992. For all of these reasons, interest m the CHEMSTAR approach to issue and research management is expected to remain high. With more companies be coming aware of CHEMSTAR and the projects already underway, expanded membership in indiv tdual panels and coun cils is also anticipated. The Biocides Panel already has more than 35 members, and the Crystalline Silica Panel recently registered its 52nd member.
The number, variety and range of regu lations and issues are expected to con tinue expanding. As the number of panels and councils increases and these groups con tinue to become larger and more complex, the techniques for managing them will also evolve. CHEMSTAR will develop innova tive ways to keep the groups responsive on ever shortening timescales. These methods will then be linked to efficient mechanisms for informing all members and maintaining their active participation in the decision making process.
CHEMSTAR stands ready to meet the chal lenges of the 1990s.
June 1990
3
CMA 030614
THE BUSINESS COUNCILS
n October, the Board of Directors approved a new category of self-funded organizations under the Asso-
/ciation~the Business Councils. These councils may address research, data-gathering. program and advocacy uc tivities in those designated business set tor or business function areas that are part of. or significant to. chemi cal manufacturing interests. Within CMA. the CHEMSTAR Division was designated to provide management support for the Councils.
Member companies focusing on business areas closely allied with chemical manufac turing (such as chemical distribution) or on improvement of business performance (such as total quality management) can now form self-supporting groups to address these is sues under CMA auspices. A typical Coun cil w ill decide on short- and long-term goals, formulate strategies, establish necessary task groups, develop a budget and an agreement for cost sharing among members, recruit ad
ditional members, and establish net works with other interested organi zations.
Like the chemical-specific Pan els. the advantages of the Busi ness Councils are many. Council members benefit from the experiences of other members as innova tive approaches to solv ing generic problems arise from group dis
cussions. Companies develop a cohesive approach to legislative and regulatory issues in these specialized areas. The financial burden of research is lightened by sharing the costs and effort with other companies that have a vested interest in the results. And all activities are conducted under standard CMA procedures designed to protect against antitrust violations.
During the seven months since initiation of the Business Council concept, four groups have begun exploring formation. At year's end. the Total Quality Council is chartered and two others are in various stages of the approval process.
The Business Councils represent an impor tant new service offered by CMA. The CHEMSTAR Division welcomes the op portunity to explore topics for new Coun cils and invites contacts from CMA mem ber companies.
CMA 030615
4
TOTAL QUALITY COUNCIL
DATE CHARTERED I WO
CL RRENT T \Sk GROl PS ASQC Liaison Education International
Affairs Pubhcitv
chairman
Ru\ tiiond Atrehcr\ Quantum C hcMCiicjl
COLNCIL MANAGER Langley Spurlock
The Council formed to address quality man agement issues of concern to the chemical manufacturing industry. Activities include: integrating quality concepts within the chemical and related industries, advocating the interests of the chemical industry before quality standard-setting organizations (domestic and international) and related government agencies, and encouraging the development of educational and training programs on quality management.
In April the Council represented CMA at hearings before the National Institute of Stan dards Technology. CMA's testimony, along with a majority of more than 70 speakers, supported more government interaction in the existing voluntary standards develop ment and implementation system.
During the next year the Council seeks to become an active player in the voluntary standards system, both within the US and internationally.
5
Total Quality Coum.il Organizational Meeting CMA 030616
NEW PANELS
m m uring 1989-90, three new panels were requested and approved. Manufacturers and users ofan individual chemical -- Cohalt -- and two chemical categories -- Brominated Flame Retardants and Chlorinated
Pool Chemicals -- organized, in two instances (cohalt and chlorinated pool chemicalsi, manufacturers simplv had a proactive interest in worker safety and customer education in the areas of safe handling, transportation and storage techniques. The driving force for the Brominated Flame Retardants group was concern about the e.xtent and types of EPA-required testing under TSCA. All three panels are now fully organized and proceed ing toward their initial objectives.
Brominated Flame
Retardants
l.
J
DATE CHARTERED' I WO
CURRENT TASK GROUPS' Analytical Chemistry Executive Committee Toxicology Research Users' Group
CHAIRMAN: Don L>nam
Ethyl Corporauon
PANEL MANAGER Has Shah
The Brominated Flame Retardant Industry Panel, a group that formed in 1985 under the auspices of the Fire Retardant Chemi cals Association, became a CHEMSTAR Panel in January.
As part of CHEMSTAR. BFRIP submitted comments to EPA on the Twenty-Fifth Re port of the Interagency Testing Committee. The report recommends that EPA mandate the testing of several brominated flame re tardant chemicals for potential environmental and health effects. A proposed test rule from EPA is expected by late 1990. BFRIP mem ber companies responded individually to the request in the Twenty-Sixth ITC Report for information on seventeen additional bromi nated flame retardant chemicals.
Efforts continued on research initiated prior to the Panel's move to CMA. The Panel obtained EPA approval for sampling proto cols developed for selected BFRs under the Dioxin/Dibenzofuran TSCA Section 4 Test Rule. The Panel also submitted analytical protocols for these chemicals to EPA for approval. The Agency response is expected in August or September of 1990.
BFRIP decided to partially fund a research project at the University of North Carolina to investigate the atmospheric stability ot polybrominated dibenzodioxins and polybrominated dibenzofurans. Comple tion of this project is expected in two sears.
The Panel monitored European regulatory activities and established a liaison with EBFRIP, the European Brominated Flame Retardant Industry Panel, to coordinate US and European activities on BFRs, The Panel plans to present BFRIP-sponsored research at the Tenth International Conference on Dioxin in September 1990. to be held at the University of Bayreuth in the Federal Re public of Germany.
Panel member companies will continue to work with EPA as the Agency reviews ana lytical protocols submitted under the Dioxin/Dibenzofuran Test Rule. The Panel will respond to the proposed TSCA Section 4 test rule when it is published, and will continue to monitor both US and foreign regulatory activities.
6 CMA 030617
Chlorinated Pool Chemicals
DATE CHARTERED: 1989
CIRRENT TASK GROUPS. Transportation
chairman
Djvid Stocker Monsanto
Hazard Assessment
Chemical Company
Cobalt
DATE CHARTERED: 1989
CURRENT TASK GROUPS:
None
CHAIRMAN-
David Beboui
PANEL MANAGER: Susan Howe
The Hall Chemical Company
PANEL MANAGER. Barbara Francis
The Panel formed to promote safety prac tices worldwide in the processing, packag ing, warehousing, transportation and use of chlorinated pool chemicals.
Initially, the Panel produced a videotape that provides information on dealing with pool chemical emergencies. Additionally, a bulletin containing guidelines for safe han dling and storage of pool chemicals has been completed. Both the videotape and the bulletin are being widely distributed to emergency response personnel.
The Panel is preparing a transportation bul letin which should be available for distri bution in 1990. The Panel will continue to interact with code-setting organizations such as the National Fire Protection Association and intends to conduct laboratory research to aid code- and standard-setting agencies in better classifying pool chemicals.
The Panel formed to interact with regula tory agencies and other appropriate organi zations on cobalt safety, health, and envi ronmental issues. The first focus of the Panel was to assess current toxicological information for adequacy and to address the June 1990 International Agency for Research on Cancer review of cobalt and cobalt com pounds.
The Panel interacted with several interna tional organizations in sponsoring an ob server to the June 1990 IARC meeting. Through their combined efforts, they were able to provide IARC with valuable infor mation which was used in their assessment and classification of cobalt and cobalt com pounds as a Group 2B animal carcinogen, rather than as a Group 2A human carcino gen.
In the future, the Panel will address envi ronmental issues that affect cobalt, which in clude the ATSDR draft toxicity profile that is due to be published in the fall of 1990.
7 CMA 030618
CONTINUING PANELS
#<y orry-nine CHEMSTAR Panels are now officially approved hy CMA. At year' s end. three new groups aw ait M. official approval--Methyl Bromide. Nitrosamines. and Sodium Bromide. CHEMSTAR membership rosters during the year included 250 companies and 21 associations. Among the company members. 104 were members of CMA and 19 were non-US and non-Canadian. Participating companies and associations were represented on panels and task groups by approximately 340 persons with professional skills ranging from physical and biologi cal sciences, through engineering and industrial hygiene to legal and business areas.
Alkanolamines
DATE CHARTERED1982
CL RRENT TASK GROLP Toxicology Research
PANEL MANAGERJonathon Busch
Eduard Bentley Texaco Chemical
Company
ance for its own future testing. Plans are underway for the Panel to sponsordermal de velopmental studies on MEA and DEA. The Panel will monitor the efforts of certain Eu ropean firms that are conducting an oral de velopmental study on MEA. The Panel also plans to revise its status report on DEA as results of the NTP chronic dermal study on DEA become available.
The Panel provided EPA with unpublished health and safety studies and information on production, use, and exposure under TSCA Section 8(d). The Panel also monitored several studies sponsored by the National Toxicol ogy Program. These included range-finding oral and developmental studies on monoethanolamine (MEA). diethanolamine (DEA), and triethanolamine (TEA), andachronic dermal study on TEA. Following subchronic oral and dermal testing of DEA, NTP selected DEA for chronic dermal testing in rats and mice. The Panel preparedastatus report sum marizing the results of the subchronic testing of DEA by NTP.
The Panel formed to determine the toxico logical properties and environmental effects of alkanolamines in response to concern raised by a limited Japanese study implicating tri ethanolamine as a possible carcinogen in mice. However, results of subsequent published and unpublished studies in rats and mice have indicated that TEA is not carcinogenic.
Alkylphenols & Ethoxylates
DATE CHARTERED: 1987
CURRENT TASK GROUPS Environmental Survey Modeling Study Toxicology
CHAIRMAN. Richard Bennett Texaco Chemical
Company
PANEL MANAGER: Robert Romano
In cooperation with EPA. the Panel completed a voluntary national field exposure study of 30 rivers to determine the presence of nonylphenol and ethoxylates. In addition, the Panel signed aTSCA Section 4-consent order on4-nonyIphenol with EPA in February. The consent order requires physical/chemical, environmental fate, and aquatic acute and chronic testing of 4-nonylphenol.
The Panel will submit comments to the Ameri can Conference of Government Industrial Hygenists regarding the potential carcino genicity of TEA. The Panel will continue to monitor various research programs as guid
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 con cerns regarding the chemical fate and envi-
CM* 030619
8
ronmental effects of nony Iphenol. The Panel maintains liaison with the Soap and Deter gent Association on scientific and regulatory issues. Membership is open to manufactur ers. users, and formulators.
The Panel w ill continue to w ork w ith EPA on unaly zing the nony Iphenol tielddata. Results ultimately will be discussed at an open EPA/ Panel workshop. Testing under the consent order w ill continue through 1991. The expo sure assessment derived from the field study and the effects results from the aquatic btoassays will be used in risk assessments for nony Iphenol.
The Panel also supported a research pro gram on benzene-induced leukemogenesix in cooperation with API. The two-phase program investigates the effect of benzene and its metabolites on hematopoiesis in the mouse and man.
Since its formation, the Panel has pursued an active research and advocacy program. Responding to a NIOSH occupational study linking benzene exposure to leukemia, the Panel sponsored an industry epidemiology study in 1983. Also, in cooperation with API. the Panel established a research pro gram investigating subchronic toxicity, me tabolism and reproductive effects.
Biocides
DATE CHARTERED. 19X6
CL RRENT TASK GROLPS Antimicrobial Exposure
Assessment Arsenic Acid Executive Legislative Mercury Compounds Regulatory Scientific
PANEL MANAGER. Has Shah
B
CHAIRMAN Claude Wolf
Nako Chemical Company
Benzene
DATE CHARTERED 1976
CL RRENT T ASK CROLPToxicology Research
PANEL MANAGER: Carol Stack
CHAIRMAN Roger Daniel The Dow Chemical
Company
Panel activity focused on responding to pro posed benzene regulations. In August. EPA published final rules to reduce benzene air emissions from coke oven by-product re covery plants and benzene storage vessels. At the same time. EPA proposed regulations to curtail emissions from other stationary source categories, including waste opera tions and bulk transfer operations. The Panel worked closely with the CMA Hazardous Air Pollutants Work Group and the Ameri can Petroleum Institute Benzene Issues Group on comments that were submitted to EPA. The Agency issued final emission standards for these source categories in Vlarch.
In April, the Panel commented on proposed regulations for occupational exposure to benzene on Coast Guard-inspected vessels. The proposal adopted various aspects of the OSHA benzene standard, including the I ppm permissible exposure limit on exposure monitoring and medical surveillance. The Panel generally supported the proposed regulations and considered them to be flex ible and performance-oriented.
The Panel's immediate focus will be on re search: however, regulatory activities are expected to continue. Response to state ini tiatives is anticipated, particularly in Cali fornia where a "no significant risk level" has been proposed under Proposition 65 im plementation. The ACGIH TLV Committee also will recommend a lower workplace threshold limit value for consideration in 1990-91.
The Panel worked actively with EPA on implementation of the Federal Insecticide, Fungicide, and Rodenticide Act. The amended FIFRA requires EPA to reregister all pesticides by 1997 and imposes a strict schedule to meet that deadline. Under Phase 2 of the reregistration program, the Panel submitted comments and met with EPA and the Office of Management and Budget concerning EPA's proposed changes in data requirements for each product. The proposed changes expand significantly the amount of testing necessary to support the reregistration of products. As a result of Panel efforts. EPA significantly reduced the number of changed data requirements in its final guidance document. Under Phase 3, the Panel persuaded EPA to reduce the re quirements to summarize completed studies and report adverse effects. Furthermore, the Agency modified its summarization guid ance to permit an abbreviated format in certain situations.
In addition. EPA has agreed to require com panies to identify nominal, not minimum, concentrations on antimicrobial product la bels. The Panel also participated with other industry associations in discussions with EPA and OMB concerning the Label Data CallIn. The discussions resulted in clarification of information submission requirements and extended deadlines for registrants with large numbers of registrations. The Panel pro vided input to EPA on the Agency's newly developed Registration Booklet that out lines procedures for registrations, amend-
9 CMA 030620
menis. and other administrative requirements tor pesticide registrants.
The Legislative Task Group monitored leg islation in both houses of Congress on pesti cides. identity ing several areas of concern to Panel members. These include: food safety, pesticide exports, and proposed amendments to FIFRA that would modify the cancella tion and suspension prov ixions and increase registration maintenance fees.
The Panel continued to work with the Cali fornia Department of Food and Agriculture to minimize data requirements for industrial biocides under the Birth Defects Prevention Act. The Panel also monitored the implem entation of Proposition 65 and provided guid ance to Panel member companies on re sponses to regulations.
The Panel filed comments with Agriculture Canada on a proposed restructuring of pesti cide registration in Canada. The Panel's comments point out ways in which indus trial biocides differ from other pesticides and recommend appropriate distinctions in regulatory treatment.
The Antimicrobial Exposure Assessment Task Group submitted a final report to EPA in March on an antimicrobial exposure as sessment study conducted in response to a 1987 data call-in. The objective of the study was to measure exposure of applicators to active ingredients used in nonagricultural biocides under actual conditions of use. w ithin a specified array of application meth ods and use settings. The protocol for the study was approved by EPA, and the study was conducted tn accordance with good labo ratory and field practice requirements. The report concluded that dermal dosing levels, while applying biocides by various applica tion methods, were mostly below the typical dose rates reported for agricultural pesti cides applied by similar methods.
The Arsenic Acid Task Group, which is concerned with arsenic, chrome and copper compounds, continued to work with EPA on the Chromated Arsenical Reregistration Standard. The Task Group persuaded EPA to allow testing of arsenic acid and chromic acid as representative compounds, rather than to require testing of all formulated prod
ucts. and succeeded in reducing the amount of required testing under the various data call-ins and the Reregistration Standard. This reduction lowered the cost of testing from about S7 million to less than S1 million. As part of a negotiated program on ecological effects, the Task Group initiated aquatic and avian toxicity testing for arsenic acid and chromic acid. The testing is scheduled for completion by summer 1991. The Task Group will work with EPA in determining the health effects data needs and will con duct the testing necessary to support the reg istration requirements.
In an expansion of scope, the Task Group responded to the FIFRA Phase 2 Reregistra tion Guidance for copper and copper oxides used in wood preservatives. The Task Group will work with EPA to determine the data needs and will generate the required data to support the reregistration requirements. The Task Group also worked with the Consumer Product Safety Commission on a research project to determine the extent of release of arsenic from playground equipment. The Task Group reviewed the protocol for the project and provided comments to CPSC. The Commission is scheduled to issue its final report in fall 1990.
The Mercury Compounds Task Group initi ated aquatic toxicity, avian toxicity, skin sensitization, and subchronic dermal toxic ity testing with phenylmercuric acetate in re sponse to EPA reregistration requirements. All studies will be completed in 1991. The Task Group and EPA reached an agreement on phasing out the use of mercurial biocides to preserve indoor paints. The agreement responds to concerns that the presence of these chemicals in interior paint presents a health hazard. The agreement allows a phase out period for affected users, somewhat lim its the use of the products in exterior paints and coatings, and requires further scientific studies. Two Task Group member compa nies will conduct extensive research to ad dress the Agency 's concerns about the con tinued use of mercurial biocides in exterior applications.
The Panel formed in 1986 to respond to the California Department of Food and Agricul ture Data Call-In Notices on biocidal chemi cals registered in the state. The data call-ins
required that registrants submit data on chronic toxicity, oncogenicity, reproductive effects, teratogenicity, mutagenicity, and neurotoxicity. The Panel since has focused on a variety of issues impacting the biocides industry as a whole, and various task groups have addressed issues surrounding specific biocides.
The Panel will continue to focus on EPA's implementation of the FIFRA amendments, including data call-ins to be issued by No vember 1990. and new container, storage and disposal regulations. The Panel also will monitor EPA's export policy and pesticide labeling activities. California activities likely will include initiatives on the November 1990 ballot that may impact Panel biocide manufacturers. The Panel will submit comments to the Canadian government in connection with its ongoing revision of pes ticide registration procedures. The Panel plans to hold a conference on Canadian pes ticide regulations in fall 1990.
CMA 030621
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Butadiene
DATE CHARTERED1984
CLRRENTTASKGROLPS, Toxicology Research Industrial Hygiene Ethy lene/Propy lene OSHA Activities
CHAIRMAN'. Norman Morrow Ewon Chtfmit.ai
Americas
PANEL MANAGER Elizabeth Moran
The Panel joined with the International In stitute of Synthetic Rubber Producers to de velop comments and testimony for the up coming OSHA rulemaking on a workplace standard for butadiene. As part of this activ ity. the Panel explored alternative risk as sessment methodologies for butadiene, which use all available biological, mecha nistic. and species differences data in esti mating risk. The Panel is developing a re search program to better understand the bio logical effects of butadiene, and to allow more accurate estimation of the potential risk to humans.
The Panel added advocacy activities on three related chemicals: ethylene, propylene, and 4-v inyIcyclohe.vene. For ethylene and pro pylene. the major goal is to obtain delisting from the SARA Section 313 list. Petitions tiled by the Panel were denied, although EPA recognized that these chemicals are not directly toxic. To further bolster its legal position, the Panel filed comments jointly with the Cyclohexane and Fluorocarbon Panels opposing the proposed listing of CFCs on the SARA Section 313 list. The proposal was based upon indirect effects and specifi cally referenced the listing of ethylene and propy lene for similar effects. The third chemical. 4-VCH. is inadvertently produced during butadiene manufacture and use. and was listed by the Interagency Testing Com mittee for test rule development under TSCA Section 4. The Panel and IlSRP are working with EPA to develop a consent order that will address the 1TC concerns.
The Panel formed in the aftermath of EPA consideration of butadiene under TSCA Section 4( f). The Panel aimed to collect and evaluate information needed to assess safety, environmental, and health issues arising from production, storage, transportation, use. and disposal of butadiene. The Panel provided comments to the Agency on two risk assess ments and worked with the Agency in as sessing "short-term" releases of butadiene. EPA then referred butadiene to OSHA under TSCA Section 9(a>. for development of a workplace standard.
The Panel will continue to follow the devel opment of the OSHA workplace standard on butadiene. In addition, butadiene will be among the first chemicals regulated under the Clean Air Act amendments. The Panel has begun a study aimed at determining the fugitive emissions for butadiene, the results of which will be useful in CAA discussions. The Panel also will be active in negotiating and implementing consent order and volun tary testing on 4-VCH under TSCA Section 4. The Panel is still exploring ways to modify the EPA position on the listing of ethylene and propylene under SARA.
Butylated Hydroxytoluene
date chartered1977
CLRRENTTASK grolps None
PANEL MANAGER: Susan Howe
The Panel continued cooperative efforts with the European BHT Manufacturers Associa tion through meetings and information ex change. The Panel submitted information for inclusion in "Summary Ev aluation of the Mutagenicity/Genotoxicity of BHT." At the request of EBMA, the Panel also submitted its literature review. "Hemorrhagic Effects of Butylated Hydroxytoluene," for consid eration at the thirty-seventh meeting of the Joint FAO/'WHO Expert Committee on Food Additives.
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 filed com ments in response to an FDA proposal for interim regulations requiring testing to re solve safety questions. To date. FDA has not issued an interim regulation. The Panel submitted a Citizen Petition in 1986 request ing that FDA issue a regulation recognizing a prior sanction for use of BHT. The FDA has not yet announced a date for its decision on the Petition.
The Panel will submit environmental and health data to the International Maritime Organization for consideration under the MARPOL Annex III shipping regulations. The Panel also will cooperate with FDA in its continuing evaluation of BHT and may develop additional scientific information, if appropriate. In addition, the Panel is await ing the results of the EBMA-sponsored study. "The Role of Hepatocellular Injury m the Chronic Toxicity of BHT," and will main tain working relations with EBMA to facili tate the possible submission of the study to FDA.
11 CMA 03062
Chlorine Dioxide
D-VTE chartered 1488
ftRENT task crol PS. Communication
Technical Regulatory
Toxicology
CHAIRMAN Gregory Becker Drew Chemical Co
Health Advisory Report which is the basis tor the Drinking Water Standard. The Panel also will consider sponsoring a follow-up international symposium on chlorine diox ide in late 1991.
Chlorobenzenes
Cresols
DATE CHARTERED' 1984
CL RRENT TASK GROl'P, Advocacy
PANEL MANAGER: Barbara Francis
chairman
Kirby Boston Menchem Company
PANEL MAN ACER: Robert Romano
In response to FIFRA data call-in require ments. the Panel began a voluntary rabbit teratology study on sodium chlorite. The panel also began working with EPA on rereg istration of chlorine dioxide under FIFRA. The Panel worked closely with the EPA Office of Drinking Water on the upcoming standard for sodium chlorite. The Panel cosponsored a very successful symposium in November with EPA and the American Water Works Association Research Foun dation. By serving as a forum for scientific presentations, the symposium promoted the further use of chlorine dioxide as a disinfec tant of potable drinking water.
The Panel formed in anticipation of an EPA proposal to regulate chlorine dioxide under the Safe Drinking Water Act by 1991. In addition, the State of California contracted for a risk assessment on chlorine dioxide and sodium chlorite. The Panel aims to gather, review, generate, and disseminate informa tion on chlorine dioxide and its precursors, sodium chlorite and sodium chlorate. The Panel monitors and interacts with regulatory agencies and fosters scientific communica tions, Primary focuses of the Panel are gen eration. applications, health effects, safety, and test methods of chlorine dioxide.
Future Panel activities include completion and final audit of the sodium chlorite teratol ogy study. Panel representatives will con tinue to interact with EPA on FIFRA data call-ins and reregistration, and with the Of fice of Drinking Water. The Panel will undertake additional testing which EPA may require under FIFRA. The Panel will spend a significant amount of time reviewing and commenting on the EPA Chlorine Dioxide
DATE CHARTERED' 1974
CIRRENTTASKGROL PS Toxicology Research FIFRA Data Call-In 1,2.4-Trichlorobenzene
PANEL MANAGER: Carol Stack
CHAIRMAN: Jumes Bryant Siandurd Chlorine Chemical Co.. Inc
The Panel continues to sponsor research to meet testing requirements under TSCA Sec tion 4 and a FIFRA Data Call-In on paradichlorobenzene tPDCB). The Panel com pleted a 21 -day dermal study on PDCB. and acute toxicity studies on PDCB in Daphnia (freshwater invertebrate) and the bobwhite quail. A comparative pharmacokinetics study also was completed and report prepa ration is in progress.
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 continues to provide technical support for the advo cacy activities of the Chlorobenzenes Pro ducers Association, an affiliate of the Syn thetic Organic Chemical Manufacturers As sociation.
The Panel's TSCA testing program will continue with the conduct of dietary onco genicity studies in rats and mice on 1,2,4trichlorobenzene (TCB). Preliminary vola tility studies on TCB in dosed feed are in progress. The other primary activity will be compliance with the FIFRA Data Call-In on PDCB. An inhalation developmental toxic ity study on PDCB is in progress. Additional testing is anticipated following EPA review of submitted studies and Agency reevaluation of testing requirements.
The Panel completed testing of three cresol isomers incompliance with a TSCA Section 4 test rule and submitted the last final reports on reproductive effects in December.
The Panel formed in 1984 in response to the TSCA Section 4 test rule. Subsequently, the Panel has worked with the EPA Test Rules Development Branch. Office of Solid Waste, and the National Toxicology Program to en sure that logical and scientifically sound testing programs are conducted on cresols.
After submission of the reports required under the test rule, the Panel formed the Advocacy Task Group to maintain a liaison with EPA. The Task Group will alert the Panel to needs for further activities.
12
CMA 030623
Crystalline Silica
DATE CHARTERED 1989
CURRENT TASK CROL PS' Administrative
Analytical Methods Science Review
Regulatory and Legal
CHAIRMAN, Joseph Shapiro Inircun Corporation
Group is turning to other scientific questions as the science review nears completion. The Panel will continue to monitor and respond to other technical, regulatory, and legal is sues as they arise.
The Panel is conducting a voluntary subchronic toxicity study and a metabolite iden tification study to provide further informa tion on the effects of cumene. Results from these studies will be submitted to EPA in early 1991. The Panel will continue to inter act with EPA on hazard assessment issues.
PANEL MANAGER' Elizabeth Gortnlev
In conjunction with the Panel-sponsored science review, the Panel held the Silica/ Lung Cancer Issues Workshop in Novem ber. Over 100 industry representatives met to review and discuss the preliminary find ings of eight Panel-funded experts. Due in part to the success of the workshop, the Panel has achieved its goal of 50 members.
The Panel formed to address the 1987 Inter national Agency for Research on Cancer listing of crystalline silica as a "probable" carcinogen. [ARC classification as a prob able carcinogen automatically requires firms that mine minerals and manufacture prod ucts containing crystalline silica compliance to the OSHA Hazard Communication Stan dard. The Panel began with nine members, dedicated to bringing together the silica industry to speak with a united voice on scientific, regulatory and analytical concerns stemming from the 1 ARC Action. In another action, the National Toxicology Program proposed listing crystalline silica on its Sixth Annual Report on Carcinogens as "reasona bly anticipated to be a carcinogen." The Panel commented to NTP five times within its first year asking that NTP await the out come of the funded science review.
The Analytical Methods Task Group is plan ning an international workshop on methods for detecting and analyzing silica content. The w orkshop is scheduled for August 1991. The Regulatory/Legal Task Group will continue to follow the NTP listing proc esses. The Panel also will submit comments to OSHA on the use of automatic triggers and to the Mine Safety and Health Admini stration on permissible exposure limits for crystalline silica. The Science Review Task
Cumene
DATE CHARTERED' 1985
CURRENT TASK GROL PS. Health Effects Environmental Effects
PANEL MANAGER Barbara Francis
CHAIRMAN. Gene Hamilton
Georgia Gulf Corporation
In compliance with a TSCA Section 4 Test Rule issued in 1988. the Panel initiated test ing of health and env ironmental effects and environmental fate. The testing was com pleted in March, and the Panel decided to conduct further voluntary testing.
Through a judicial challenge, the Panel sought definition of "substantial" exposure limits by which the Agency can require test ing under TSCA Section 4(a)(1)(B). In April, the Court ruled that EPA did not justify the test rule for cumene because meaningful criteria for defining "substantial or significant" environmental release and human exposure had not been established. The Court remanded the test rule to EPA and directed the Agency to provide a rationale forits exposure findings. The Court declined to stay the rule largely because most of the first-tier testing under the rule had been completed.
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 objective is to collect information that will allow assessment of health and environmental effects arising from production, storage, use and disposal.
Cyclohexane
DATE CHARTERED' 1985
CURRENT TASK GROUP Toxicology Research
PANEL MANAGER' Jonathon Busch
CHAIRMAV Russell Cook Phillips Chemical
Company
The Panel is preparing for a final TSCA Section 4 test rule. EPA has delayed publi cation. This delay occurs in part because EPA has not developed criteria for defining substantial or significant exposure. Because of a recent court decision, the final test rule on cyclohexane will be delayed until EPA can develop an exposure definition which would apply generically to all chemicals subject to TSCA test rules. In preparation for the final test rule, the Panel reviewed bids from qualified laboratories to perform the research.
The Panel submitted comments to EPA op posing a SARA Section 313 listing petition filed by the National Resources Defense Council and the Governors of New Jersey, New York, and Vermont. The Panel's com ments outline reasons why cyclohexane does not meet any of the statutory requirements for 1 isting under Section 313. The Panel also undertook advocacy activities to affect amendments of the Clean Air Act.
Cyclohexane manufacturers formed the Panel to address the Interagency Testing Committee's intent to designate cyclohex ane for priority testing under TSCA Section 4. EPA formally designated the chemical for health effects testing in 1986.
The Panel will comment to EPA on the an ticipated TSCA final test rule and will spon-
13 CMA 030624
Mir required research as appropriate. The Panel also will work with the Butadiene Panel to develop specific language for rec ommended legislative action on SARA Section 313. The legislation would elimi nate unnecessary reporting and prevent chemicals that have only indirect health ef fects from being listed.
Diisocyanates
DATE CHARTERED WSK
CURRENT TASK GROL PS, Industrial Hygiene Health Effects
PANEL MANAGER' Robert Romano
CHAIRMAN James Chapman Moba\ Corporation
Rules Development Branch to develop ap propriate responses under TSCA Section 4 will continue. The Panel also will continue to interact and coordinate activities with SPI and the International Institute on Isocyanates.
Dinitrotoluenes
Dibenzofurans/ Dibenzodioxins
DATE CHARTERED' 1984
CURRENT TASK GROUPS. None
PANEL MANAGER: Elizabeth Gormlev
CHAIRMAN' Kenneth Burgess
The Dow Chemical Company
The Environmental Defense Fund and the National Wildlife Federation appealed the 1988 summary judgment of their lawsuit against EPA. In the suit, EDF and NWF sought to force the Agency to initiate a TSCA Section 6 rulemaking on dioxins. The Federal Court ruled in favor of the Agency's right to "set its own priorities" in the face of citizens' petitions. The Panel decided to continue lo participate as an intervenor on behalf of EPA in the appeal of this lawsuit.
The Panel formed w hen EDF and NWF filed the TSCA Section 21 Petition. In addressing .lie EPA response, 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 diben zodioxins as impurities and the reporting of production, processing, use. exposure, and disposal data.
The Panel is awaiting the outcome of the appeal. With conclusion of the lawsuit draw ing near, the Panel will monitor the dioxin issue and consider new activities.
The Panel participated in the EPA open meeting on the Health Assessment Docu ment for toluene diisocyanate. Panel pre sentations were, well received by the Agency. The Panel monitored the State of Califor nia's listing of toluene diisocyanate as a potential carcinogen under Proposition 65 regulations. The Panel worked closely with the Society of the Plastic Industry to inform the hundreds of users of TDI in California of their reporting and labelling requirements under Proposition 65. The Panel also worked closely with several other states on their upcoming Air Toxics Regulations. A draft model using Industrial Hygiene data to pre dict fugitive emissions has been prepared by the Panel. This model has significant ge neric applications for predicting fugitive emissions for many chemicals.
The Panel formed to develop and dissemi nate information on the safe handling of diisocyanates, including: toluene diisocy anate. methylenebtsdiphenyl diisocyanate, hexamethylene dnsocyanate. and methylene bis-dicyclohexyl diisocyanate. Monitoring impending regulations affecting the produc tion or use of diisocyanates and developing responses as needed are also key Panel ac tivities.
The Panel will continue to work with the EPA Office of Air Quality Planning and Standards on the TDI Health Assessment Document, and wuh the State of California on implementation of Proposition 65. Work will continue between the Panel and several states as state Air Toxic Regulations are being developed The Panel also will ad dress some of the 43 isocy anates listed by the ITC in the intent to designate category of its 26th list to the EPA Administrator. Negoti ating between the Panel and the EPA Test
DATE CHARTERED1989
CURRENT TASK GROUPToxicology
PANEL MANAGER: Barbara Francis
CHAIRMANThomas Mamot Air Products and Chemicals. Inc,
As part of a voluntary agreement with the EPA and agencies of the Federal Republic of Germany, the Panel is conducting a pharma cokinetics study. The results of this study will be submitted to the government agen cies in 1991. In addition, the US member companies provided environmental release information on 2.6- and 2,4-dinitrotoluene to the EPA.
The Panel formed to permit US manufactur ers to work with Bayer AG on a voluntary testing program. Representatives of the l S EPA and FRG agencies identified DNT as a possible subject for cooperative testing by companies in both countries. The agencies' stated objectives were to promote sharing of the cost of research and to ensure the availa bility of adequate hazard data in both coun tries. The Panel member companies and Bayer AG agreed to undertake a pilot phar macokinetics project in response to the agen cies' request.
The Panel will complete the pharmacokinet ics study and will continue to interact with EPA and the FRG agencies in assessment of results.
14 CMA 030625
Ethylene Dibromide
Ethylene Dichloride
DATE CHARTERED. 1982
DATE CHARTERED1974
CLRRENT TASK GROLPS:
CHAIRMAN:
None
Vernon White Greal Lakes Chemical
PANEL MANAGER
Corporation
Robert Romano
CLRRENT TASK GROLPS None
PANEL MANAGER Has Shah
Ethylene Glycol
DATE CHARTERED1986
CHAIRMAN: Vacant
CLRRENT TASK GROLP: Toxicology Research
PANEL MANAGERCarol Stack
CHAIRMAN Dennis Macaulev
L'mon Carbide
Corporation
OSHA has not yet issued a final rule revising the federal Occupational Standard for ethyl ene dibromide. The Panel therefore had no need to meet this year.
The Panel formed to address the OSHA Standard with the goal of ensuring that rea sonable regulations are adopted. Once the rule is issued, the Panel will review the re quirements and evaluate the effects on the industry.
No new activities were undertaken by the Panel this year.
The Panel formed to address federal and state agencies in all safety and health issues arising out of the production, distribution, and use of EDC. Initially, the panel focused on evaluating scientific literature, identify ing data gaps, and undertaking additional toxicological studies to improve the research data base. The Panel voluntarily sponsored studies of chronic inhalation, metabolism, and teratogenicity.
The Panel will monitor agency activities and take action as appropriate.
The Panel is in the last phase of a voluntary research program to supplement the toxico logical data base on ethylene glycol. The Panel completed an oral developmental tox icity study in rats and established a no-ob served effect level. A comparative pharma cokinetics study in female mice also has been completed and the final report is being prepared.
The Panel formed to augment the toxico logical data base on ethylene glycol. In par ticular, the Panel has focused on investigat ing the potential for developmental toxicity and pharmacokinetics research in mice and rats.
The Panel will meet this fall to consider future activities. Focus will be on further research needs, the impact of completed work on ethylene glycol risk assessment, and communication of the research findings to customers and within member compa nies.
15 CMA 030626
Ethylene Oxide
DATE CHARTERED, 1481
Cl RREM T ASK GROl PS Scientific Industrial Hygiene Em ironmental Toxicology Economic Risk Assessment
chairman, Ronald \an Msnen
l mon C'jrbide Corporation
PANEL MANAGER. Robert Romano
The Ethylene Oxide Industry Council and Chemical Industry Institute of Toxicology cofunded an EO pharmacokinetics physio logical modeling study being conducted at CUT. The EOIC also tracked the reauthori zation of the Clean Air Act. which could affect EO production facilities. The results of the EOIC screening study for fugitive emissions were accepted by EPA and w ill be used by the Agency in its Fugitive Emissions Regulation. In addition. EOIC worked with ATSDR to determine the fate of the SARA Section 110 EO toxicological profile report. The Panel feels that ATSDR development of the profile is inappropriate since EO is not found at waste sites. The Panel also spon sored a very successful "EO Information Exchange" workshop on environmental and safety issues related to EO production.
The Panel formed to evaluate the results of an animal study that may affect OSHA and EPA regulatory proceedings on EO. The EOIC addresses many regulatory and scien tific activities in an effort to provide both agencies with enough information to make reasonable and scientifically sound deci sions on regulatory controls.
The CUT pharmacokinetics physiological modeling study will continue, as well as a broad review of all EO epidemiology data. To better aid EPA. the EOIC has decided to sponsor an EO industry-wide fugitive emis sions bagging study to further quantify EO emtssions for SARA Section 313 reporting and risk assessment. The EOIC plans to meet with ATSDR to discuss additional
concerns with the EO toxicological profile. A second "Information Exchange" work shop focusing on transportation of EO is planned by the Panel.
2-Ethylhexanol
CHARTER DATE: 1986
CURRENT TASK GROUPS: Toxicology Research Butyraldehyde Butyraldehyde
Environmental Butyraldehyde Toxicology
CHAIRMAN: Richard Wise Union Carbide
Corporation
PANEL MANAGER: Has Shah
In October, the Panel along with the Iso propanol and Phthalate Esters Panels filed joint comments on the EPA Interim Final Rule on Procedures Governing Testing Con sent Agreements and Test Rules. The Final Rule was published by the Agency in May 1989.
The survey was submitted to EPA in Sep tember because the 1TC had recommended health and ecological effects testing of bu tyraldehyde under TSCA Section 4 if sig nificant worker and general population ex posure to the chemical were demonstrated. Based on very low workplace, general popu lation, and environmental exposure levels found, the Panel concluded that health and environmental effects studies are not war ranted. The Agency's independent assess ment of the exposure levels was similar to that of the Task Group. The EPA Exposure Assessment Branch has transmitted these conclusions to the Test Rule Development Branch which will make the decision on the TSCA Section 4 rule. The Task Group will respond when EPA publishes its recommen dation.
The Panel formed to address the TSCA Sec tion 4 test rule issued by EPA at the request of the National Toxicology Program. NTP requested this testing when budget cuts forced the cancellation of its two-year rat and mouse bioassay. The final rule was published in August.
The Panel will continue to monitor the prog ress of the oncogenicity and pharmacoki netic studies.
The Toxicology Research Task Group con tinued to monitor the progress of the onco genicity studies at BASF in Germany. The in-life portion of the mouse oncogenicity study was completed in May, and the rat on cogenicity study will be completed in Sep tember 1990. The Panel initiated dermal and oral pharmacokinetic studies in November. The data will be used in toxicity studies to de termine the potential health risks associated with human exposure. The study is expected to be complete by December 1990.
The Butyraldehyde Task Group developed and conducted a survey to gather informa tion concerning the production and use of bu tyraldehyde in the United States and worker, general population, and environmental ex posure levels. The survey included all pro ducers and several major users of the chemi cal.
16 CMA 030427
Fluoroalkenes
DATE CHARTERED1987
a RRENT TASK GROl PSSpecific Chemicals
Producers Specific Chemicals
Toxicology
PANEL MANAGER. Jonathon Busch
CHAIRMAN Roland Slahl E I Ju Pont de Nemours tk. Co
The Panel complied with a TSCA Section 4 rule requiring testing of four fluoroalkene monomers for mutagenicity, subchronic tox icity, and oncogenicity. The monomers are vinyl fluoride, vinylidene fluoride, hexafluoropropene, and tetrafluoroethene. The Panel submitted final reports to EPA for review on all completed studies. Oncogen icity testing of vinylidene fluoride and vinyl fluoride is still in progress.
The Panel presented comments at an EPA TSCA Section 4 Public Program Review on fluoroalkenes. At the review, industry and Agency scientists discussed the results of lower tier testing conducted under the fluoro alkenes test rule. On the basis of the Panel's comments, the Agency rescinded the heri table translocation assay requirement for hexafluoropropene and vinyl fluoride.
The manufacturers of the fluoroalkene mono mers originally formed an ad hoc coalition to address the tTC's 1980 designation of fluoro alkenes for priority testing consideration under TSCA Section 4. The coalition reor ganized as a panel under the auspices of C\1A after the test rule was final.
The Panel is awaiting the Agency's decision on whether an oncogenicity study for hexafluoropropene and a mouse-specific lo cus study for vinyl fluoride will be required. The Agency's decision will depend on re sults of lower tier testing. Lower tier testing includes a mouse micronucleus test with hexafluoropropene: and an alkaline elution study and an unscheduled DNA synthesis study with vinyl fluoride which are in prog ress. The mouse specific locus test require ment for vinyl fluoride will be rescinded if
both the alkaline elution test and the un scheduled DNA synthesis tests are negative.
The Panel plans to sponsor required tests and will interact with EPA in the evaluation of testing requirements.
Fluorocarbons
DATE CHARTERED: 1973
CL RRENT TASK GROLPS: Scientific Review Effects External Affairs Recognition
CHAIRMANS. Robert Orfeo Allied-Signal Inc.
PANEL MANAGER: Elizabeth Gormley
In keeping with a decision to end Panel ac tivities in 1990. the Panel sought tocomplete the research projects in progress and prepare to terminate in an orderly fashion. The only new funding was in support of several work shops on biological and ultraviolet (UV-B) effects issues.
The Panel formed to fund research to deter mine the environmental fate of CFCs. To date, the Panel has supported projects to talling more than S25 million. Sponsored studies have addressed atmospheric chemis try, atmospheric measurements, modeling and trend analysis. The Panel focus has broadened in recent years to include the monitoring of developments in the climate/ greenhouse and biological effects research areas.
A report listing the investigators and sum marizing the results of all the projects funded by the Panel, and a brochure outlining the history of the Panel, will be published as the final tasks. Panel member companies will elsewhere pursue efforts to develop safe, ef ficient alternatives to CFCs.
Glycol Ethers
DATE CHARTERED: 1980
CURRENT TASK GROUPS
Toxicology Research SARA Section 313
CHAIRMAN Richard Wins
Delisting
Union Carbide Chemicals and Plastics
PANEL MANAGER:
Company [nc
Carol Stack
The Panel's research and advocacy activi ties continued to focus on ethylene glycol butyl ether (EGBE). diethylene glycol butyl ether (DGBE) and its acetate (DGBA), and triethylene glycol ether methyl ether (TGME). A voluntary research program on EGBE is in progress. The program includes in vitro hemolysis studies in rat and human red blood cells, and the development of a physiologically based pharmacokinetics model for EGBE risk assessment. The Panel also contracted with a public relations firm which produced an information brochure, "Dissolving the Myths about EGBE and Health," which reviewed the health effects data base and existing regulations on EGBE.
The Panel completed studies required under a TSCA Section 4 Test Rule on DGBE/ DGBA. DGBE was tested for mutagenicity, subchronic toxicity/fertility effects, and neurotoxicity. A comparative pharmacoki netics study on DGBE and DGBA also was completed. A developmental neurotoxicity study was included in the final test rule pend ing EPA program review of the Tier 1 test ing. EPA decided not to require the study, as Tier 1 test results were uniformly negative.
The Panel successfully negotiated a consent order in lieu of a TSCA Section 4 test rule on the methylene glycol ethers. The member of the class subject to testing is TGME. EPA and the Panel did not agree on the need for inclusion of developmental neurotoxicity testing in the consent order therefore EPA subsequently issued a test rule requiring the study. All testing requirements under the consent order have been met. Final reports on mutagenicity testing and developmental toxicity studies were submitted to EPA. Final study reports on neurotoxicity and subchronic dermal studies are in preparation and will be
17 CMA 030623
submitted to EPA in October Plans are being made tor initiation of' the TGVIE de velopmental neurotoxicity study later this vear.
The Panel met with NIOSH to discuss an external peer review draft of'a criteria docu ment on ethylene glycol ethers. NIOSH had selected the Panel as a peer reviewer and Panel scientists provided extensive com ments on the document. The Panel w/as successful in convincing NIOSH to issue a separate criteria document for EGBE. based on distinguishing toxicological characteris tics. The Panel also argued that the NIOSH recommended exposure level for EGBE was unnecessarily low. NIOSH's schedule calls for publication of the criteria documents by the end of the year.
Panel toxicologists met with the scientific review panel of the Research Institute for Fragrance Materials to discuss the glycol ethers data base and assist RIFM in identify ing research needs to ensure safe use of glycol ethers in fragrances. Panel members also prov ided comments on a Cosmetics In gredients Review on EGBE. A CIR Panel is responsible for scientific determinations on the safety of cosmetic components.
Panel manufacturers of EGME and EGEE and their acetates are tracking regulatory developments within OSHA. The Admini stration formally issued a call for informa tion on these chemicals, but has yet to pro pose workplace standards.
The Panel formed to develop an adequate toxicity data base on ethylene-based glycol ethers, provide information to users and government agencies on the safety of the chemicals, and promote scientifically sound regulatory action.
The Panel will complete mandatory testing under TSCA. and then voluntary testing will once again dominate the Panel's research activities. In advocacy efforts, the Panel will pursue delisting efforts, as they relate to SARA and the CAA. and will monitor state activities.
Hexamethylene Diisocyanate
DATE CHARTERED 1988
CURRENT TASK GROUP: Toxicology Research
PANEL MANAGER Carol Stack
CHAIRMAN Donald Lamb Moba> Corporation
The Panel prepared for the publication by EPA of a TSCA Section 4 Test Rule on hexamethylene diisocyanate by identifying candidate testing laboratories and request ing proposals and bids. In addition, the Panel monitored progress on final test rule development within EPA.
The Panel formed to address the inclusion of HDI on the ITC priority list of chemicals for testing under TSCA Section 4, ITC desig nated the chemical for response within 12 months. EPA responded by proposing onco genicity, mutagenicity, reproductive toxic ity, developmental toxicity, neurotoxicity, comparative pharmacokinetics and hydroly sis testing.
The Panel sponsored evaluations of air emis sions data on glycol ethers as part of an effort toward delisting members of the glycol ethers category from SARA Section 313. The Panel has explored the possibility of filing a delisting petition with EPA. The category of glycol ethers also appears on the list of toxic air pollutants in the House and Senate ver sions of the Clean Air Act Amendments. The Panel anticipates filing petitions for delisting members of the category when the legislation is passed.
EPA projected publication of the final test rule in summer 1990. Publication however has been delayed as the result of a Court directive requiring EPA to develop criteria to support a "substantial or significant" ex posure finding under TSCA Section 4(a)(1)(B). Because EPA based testing re quirements for HDI solely on this finding, the Agency currently is developing expo sure standards. EPA will then judge testing needs accordingly.
In state activities, the Panel filed comments in response to the listing of ethylene glycol methyl ether I EGME) and ethyl glycol ethyl ether (EGEE) as reproductive toxins under California Proposition 65 implementation. The Panel also responded to a call for infor mation on glycol ethers by the California Air Resources Board. In Louisiana, the Panel w as successful in limiting inclusion of gly col ethers on a list of toxic air pollutants to only those of toxicological concern.
18 CMA 030629
Hydrogen Fluoride
DATE CHARTERED1988
CURRENT TASK GROUPS. Materials of Construction Medical & Toxicology
CHAIRMAN S, C. Watkins Allied-Signal Inc
Mutual Aid
Personal Protective Equipment
CAER/Risk Communication
Storage Systems
Transportation
PANEU MANAGER: Elizabeth Gormley
The Panel approved mission statements and long- and short-term goals tor each of its newly established task groups and asked them to develop resource materials in their issue areas. In August, the Panel held its annual Safety Seminar to focus on new safety technology and techniques. In April, the Panel Chairman attended a meeting of the Comite Technique Europeendu Fluor of the Conseil Europeen des Federations de ['In dustrie Chimique and gave a presentation on the goals and activities of the Panel. This was part of a Panel effort to leant more about this group and look to areas of collaboration. The Panel agreed to co-fund a toxicology study with CEFIC and the Dutch govern ment. The Panel also monitored Congres sional and state activity on issues affecting hydrogen fluoride transportation and use.
The Panel formed to provide a forum for producers and shippers to share information on safety in the manufacture and transporta tion of, and emergency response procedures for. hy drogen fluoride. The Panel is made up of US and Mexican members.
The Panel will decide whether to expand its efforts and membership to address pending regulatory and legislative activities at the local, state, and federal levels.
Hydroquinone
DATE CHARTERED1984
CURRENT TASK GROUPToxicology Research
PANEL MANAGER Jonathon Busch
CHAIRMANRobert Brothers
Eastman Kodak Company
The Panel completed the required testing program for hydroquinone under TSCA Sec tion 4. The testing program included an evaluation of pharmacokinetics and poten tial neurotoxicity, developmental toxicity, and reproductive toxicity. All required data and reports were submitted to EPA. The Panel prepared a Research Summary Report outlining the findings and conclusions of the studies. If EPA accepts the Panel-sponsored research, then the Panel will have achieved its research objectives. The Panel also par ticipated in peer review of the NTP carcino genicity bioassays of hydroquinone with rats and mice.
The Panel formed in response to a proposed TSCA Section 4 test rule published by EPA in 1984. Subsequently, the Panel submitted extensive comments to the Agency and pre sented data at the rulemaking hearing. In addition, the Panel voluntarily sponsored a study to assess potential developmental ef fects from exposure to hydroquinone.
The Panel plans to publish the findings of its research program m a scientific journal. The Panel also will cooperate with the Non prescription Drug Manufacturers Associa tion and the Cosmetic. Toiletry, and Fra grance Association by providing these trade groups with summaries and final reports of the Panel-sponsored research. The Interna tional Agency tor Research on Cancer iden tified hydroquinone as a priority chemical for review in 1941 The completed Panel research will be submitted to 1ARC for use in its evaluation.
Isopropanol
DATE CHARTERED1987
CURRENT TASK GROUP: Toxicology Research
PANEL MANAGER: Barbara Francis
CHAIRMAN James Quance Exxon Chemical
Company
In compliance with a TSCA Section 4 Test Rule issued in December, the Panel initiated testing for health effects. Testing require ments include: subchronic toxicity, repro ductive toxicity, developmental toxicity and neurotoxicity, mutagenicity, oncogenicity and pharmacokinetics.
The Panel formed to address health effects concerns about isopropanol raised by the ITC in its 19th Report to the EPA Adminis trator. The Panel's objective is to collect in formation that will aid in the assessment of health effects arising from production, stor age, transportation and use of isopropanol.
The Panel will monitor studies required under the TSCA Section 4 test rule and will con tinue to interact with EPA regarding inter pretation and evaluation of the test results.
19 CMA 030630
i
Ketones
DATE CHARTERED 1980
will conduct advocacy on acetone, methvl ethyl ketone and methyl isobutyl ketone, as appropriate.
Metal Catalysts
DATE CHARTERED: 1984
Cl RRENT TASK GROl PS. Toxicology Research Acetone Task Group
lJ XNEL MANAGER Barbara Francis
CHAIRMAN James Quunce FAKon Chemical
Company
In an effort to resolve the TSCA Section 4 testing issue, the Panel submitted informa tion to EPA from a survey of current worker exposure to mesityl oxide. The survey re sults demonstrated that significant reduc tions in worker exposure have occurred.
In January, the Panel formed the Acetone Task Group to address US and foreign regu latory issues. The Task Group submitted comments and successfully petitioned the State of Louisiana's Air Quality Office to remove acetone from its list of one hundred toxic air pollutants.
The Panel submitted comments to ATSDR on isophorone in response to the Agency's identification of priority data needs for iso phorone and three other chemicals. Based on the negligible potential for human exposure to isophorone at National Priority List sites, and because many of the research needs have been filled through voluntary studies, the Panel is advocating that isophorone be given a low priority for further ATSDR action.
The Panel formed to address EPA activities on methyl isobutyl ketone, methyl ethyl ketone, isophorone. and mesityl oxide under TSCA Section 4. The Panel negotiated test ing programs with the Agency to augment the data base on these chemicals. In addi tion. the Panel was actively involved in discussions with the Agency on testing needs for MO and filed a petition for review of the final test rule.
The Panel will continue to negotiate with EPA in an attempt to resolve the mesityl oxide testing issue through a consent agree ment. The Panel will also continue to inter act with ATSDR regarding isophorone. and
Lubricant Additives
DATE CHARTERED1985
CL RRENT TASK GROUP: Environmental Research
PANEL MANAGER: Carol Stack
CHAIRMAN. Charles Keller Exxon Chemical
Company
The Panel continued to monitor activities related to marine transport of lubricant addi tives. In addition, the Panel considered forthcoming implementation of MARPOL Annex III. as well as data requirements under proposed EEC existing chemicals regula tions. additives handling procedures, and sulfonates sensitization testing.
The Panel organized to address anticipated international marine pollution control regu lations. An immediate concern was the need to generate marine aquatic toxicity data to support proper pollution categories for bulk shipments and to investigate the efficient stripping of unloaded tankers.
The Panel was largely successful in meeting its original goals, and is in the process of deciding where to focus resources in the future.
CURRENT TASK GROUPS, Environmental Regulations
Industrial Hygiene RCRA
w,n,jm Deenns
Gulf Chemical and Metallurgical Company
PANEL MANAGER: Susan Howe
The Panel held a joint meeting with the Japan Catalyst Manufacturers Association. Each group gave a short presentation of its activities and future courses of action. In a roundtable discussion, the groups exchanged specific concerns of the catalysts industries. The Task Groups developed advocacy posi tions in response to several proposed regula tions which impact the metal catalysts indus try, The RCRA Task Group successfully commented to EPA on the proposed thirdthird land ban of certain hazardous wastes.
The Panel formed to collect and evaluate information necessary to assess safety. envi ronmental, and health issues arising from the production, storage, transportation, use and disposal of metal- containing catalysts in in dustrial processes. The Panel has focused on a research program to characterize the toxic ity profiles of metal catalysts, with particular emphasis on nickel-containing materials.
The Panel is continuing liaison with the Nickel Producers Environmental Research Association and the European Catalysts Manufacturers Association. The Industrial Hygiene Task Group is working with NiPERA to prepare a response to the Ameri can Conference of Governmental Industrial Hygienists proposal to lower the Threshold Limit Values for all nickel compounds. The Environmental Regulations Task Group is addressing pending regulations concerning the export of wastes and hazardous wastes, especially spent metal catalysts which are frequently exported for recycle.
CMA 030631
20
Methylenedianiline
Naphthenates
Oleylamine
DATE CHARTERED. 1982
DATE CHARTERED1983
DATE CHARTERED 1984
Cl RRENT TASK GROLPS: Risk Assessment,
Medical & Toxicology Analytical and Industrial
Hygiene
CHAIRMAN: Roger Daniel Dovv Chemical
ISA
Cl RRENT TASK GROl PS: None
PANEL MANAGER Has Shah
CHAIRMAN Michael Scott
Mooney Chemicals. Inc,
CURRENT TASK GROUPS None
PANEL MANAGER: Susan Howe
CHAIRMANLincoln Metcalfe Akzo Chemicals Inc,
PANEL MANAGER: Elizabeth Moran
The Panel submitted comments and testified at the OSHA hearing on the proposed workplace standard for MDA. The testi mony addressed two major issues: the need for a level of MDA in liquid and solid mix tures below which the labeling and other provisions do not apply, and the need for physician judgment in decisions involving medical removal following abnormal clini cal findings in mandated tests.
The Panel formed in response to the ITC recommendation that 4,4'-methylenedianiline be considered for priority testing under TSCA Section 4. In 1983, EPA decided that no additional testing was necessary, but designated MDA as the first '`significant risk" chemical under TSCA Section 4(f), Ultimately, in 1985, the Agency referred the chemical to OSHA under the authority of TSCA Section 9. The Panel participated in the first negotiation of a workplace standard for MDA under the Occupational Safety and Health Act.
The Panel is awaiting the final rule for a workplace standard on MDA, which is ex pected to be published in 1990.
No new activities were undertaken by the Panel this year.
The Panel formed as a result of an ITC recommendation to EPA that calcium, co balt, and lead naphthenates be considered for priority testing under TSCA Section 4. Subsequently, the Panel expanded its scope to address EPA concerns in the pesticides area.
The Panel will decide on a course of action when it receives the EPA evaluation of its dermal absorption study. The study was part of a voluntary testing program developed by the Panel and the Agency in lieu of a TSCA Section 4 test rule.
The Panel completed the first tier of the required testing program for the TSCA Sec tion 4 test rule. The results of the mutagen icity studies in either the detection of gene mutations in somatic cells in culture assay, or in the in vivo mammalian bone marrow cytogenetics assay, indicated that oleyla mine is not mutagenic. The developmental toxicity studies showed that oleylamine is not embryotoxic. fetotoxic or teratogenic in rats or rabbits.
The Panel formed in response to the pro posed test rule underTSCA Section4 requir ing pharmacokinetics, genetic effects, sub chronic toxicity (including neurotoxi-city and reproductive tract effects), and terato genicity data.
Due to the test data and the Panel's success ful cooperation with EPA in shaping the final test rule, the Panel will not need to conduct additional mutagenicity studies under the second tier requirements. Addi tionally, the Panel will not have to conduct third tier studies or an oncogenicity study. The original research objectives of the Panel have now been achieved, so future activities of the Panel will depend on EPA's further evaluation of the research findings.
21 CMA 030632
phenol
Phosgene
Phthatate Esters
DATE CHARTERED1988
DATE CHARTERED1972
DATE CHARTERED: 1973
Cl RRENT TASK GROL PS Regulatory Toxicology Research
panel manager
Susan Howe
CHAIRMAN, Edwin Fraim
Dow Chemical ISA
Panel members shared information on safe handling procedures and safety in transpor tation. exposure treatments, sampling sys tems. safety incidents, and transportation emergency response. In addition, the Panel completed development of the criteria for the Pro-Active Safety Index -- a standard company survey methodology for assessing worker safety at manufacturing facilities. The Regulatory Task Group greatly ex panded in scope after ATSDR identified priority data needs for phenol in its pilot test program under SARA Section 110 for chemi cals found at National Priority List waste sites.
The Panel formed to promote greater safety in the production, transportation and use of phenol. Member companies exchange nonpropnetary safety information on topics such as transportation training, tank car handling, exposure treatment, sampling systems, emer gency response procedures, and waste dis posal. Health and environmental concerns about phenol are addressed by the Regula tory Task Group,
The Panel plans to use the Pro-Active Safety Index in self-assessments by member com panies. The results of company surveys will be compared by a third party and the Panel will present awards to the most successful members, in recognition of worker safety excellence at phenol-producing plants. The first annual awards ceremony will be held in September 1990. The Regulatory Task Group will continue to monitor regulatory activities that may specifically impact phe nol production, and will comment when ap propriate.
Cl RRENT TASK GROl PS Engineering and Safety
Practices Regulatory Industrial Hygiene Medical and Toxicology
aVfc
CHAIRMAN W E Irby
Mobav Corporation
PANEL MANAGERRobert Romano
The Panel's fugitive emissions field study convinced EPA that the Agency's SOCMI fugitive emissions predictors are inappro priate for estimating emissions from phos gene manufacturing sites and possibly from other chemical processes. The Panel contin ued its sponsorship of research at New York Medical College on treatment methods for accidental exposure to phosgene. The re search has moved on to canine in-life studies and has identified several medications that are effective in treatment of phosgene expo sure.
The Panel formed to improve industry's ability to safely manufacture, handle, and use phosgene. Predicting and controlling ambient concentrations of phosgene from accidental releases has become an important Panel objective.
The proceedings of the Panel-sponsored international symposium, "Remote Moni toring: Current Technology and Future De velopments Applicable to Air Toxics. In cluding Phosgene," will be published in 1990. The Panel will continue information ex change among member companies on safety techniques, and cooperation with EPA. In particular, the Panel will monitor increasing regulatory interest in phosgene. The Panel also plans to develop a phosgene mitigation data base and a field testing program to assess mitigation devices.
CURRENT TASK GROL PS: Toxicology Research Environmental Research Food and Drug
Applications
CHAIRMAN. James Samory Aristech Chemical
Corporation
Phthalic Anhydride
California Issues
FDA Toxicology Research
PANEL MAN AGERS: Elizabeth Moran Marian Stanley
This year, the Panel was very active in com menting on a number of regulations affect ing phthalate esters. In most cases, the com ments resulted in changes to the proposals.
Under SARA Section 110, ATSDR pub lished a proposed Decision Guide which will be used to determine testing needed on di-2ethylhexyl phthalate (DEHP) and other listed chemicals. DEHP was used as an example in the proposed rule. The Panel commented on the DEHP information, emphasizing that the chemical has been extensively tested and animal test results plus low levels of envi ronmental exposure lead to the conclusion that no further testing should be required. Furthermore, many studies identified by ATSDR as needed are not feasible to con duct. The Panel also commented on the draft dibenzyl phthalate toxicological profile, and the tentative testing needs included in the profile.
DEHP was listed under CERCLA Section 102 with a Reportable Quantity of one pound. The Panel submitted comments in support of an Agency proposal to raise this value and succeeded in raising the RQ to 100 pounds.
The Panel commented on a California Pro posed Maximum Contaminant Level for DEHP in drinking water. Although DEHP is not expected to be present in drinking water above the proposed PMCL, the Panel's comments were aimed at making the PMCL consistent with the no significant risk level set under Proposition 65.
22 CMA 030633
In continuation of the Panel's cooperative program of information exchange with the CEFIC Plasticizers Sector Group, the Panel hosted the second joint meeting of the two groups in June 1990. The two groups plan to continue meeting annually, and will pursue some joint projects during the next year.
The Panel formed in 1972 to address envi ronmental issues. In 1976, the Interagency Testing Committee listed the alkyl phthalate category for test rule development under TSCA Section 4. The ITC also included health effects testing in its concerns follow ing the release by NTP of bioassay results on DEHP and di-2-ethylhexyl adipate. In 198081, 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 re sults were submitted to the Agency along with a proposal for further environmental testing. In 1988. the Panel and EPA agreed on an environmental testing program which is being conducted under a consent order.
The Panel is exploring alternative risk as sessment strategies for DEHP. In one strat egy. the Panel is exploring use of a new risk assessment modeling procedure. The proce dure uses results of mode of action studies in a two stage model of Moolgavkar and Knudson, rather than the linear multistage model which uses only bioassay data.
Reproductive and developmental toxicity of phthalate esters appears to be the least well understood of all the research questions fac ing the Panel. To further understanding, the Panel has contracted with an expert in this area, to review and analyze the published and unpublished literature. The outcome of the review will be a published article, in a peer reviewed journal. The work in particu lar will be used to support the Panel's advo cacy in California.
In federal advocacy, the Panel will work with ATSDR and EPA to avoid inappropri ate or unnecessary testing requirements on DEHP, DBP and other phthalates under SARA 110. The Panel also will comment on revised EPA water quality criteria for DEHP and DEHA. which are expected to be pro posed in late 1990. The Panel is planning to publish results of environmental effects test
ing to provide better data to states develop ing regulations (especially water regula tions). Finally, the Panel will address the inclusion of phthalates in the air toxics title ot C A A amendments, and develop a strategy for deleting phthalic anhydride from the air toxics list.
Polychlorinated Biphenyls
DATE CHARTERED: 1981
CURRENT TASK GROUPS:
CHAIRMAN.
None
John Craddock Monsanto Company
PANEL MANAGER. Elizabeth Gormley
In December, EPA issued a new notification and manifesting rule under TSCA for man agement of PCB wastes. The Panel, work ing within a consensus group of industry or ganizations and environmental groups, had long advocated publication of this rule as the best way to address Congressional concerns about mismanagement of PCB wastes, par ticularly by commercial storers and dispos ers. The Panel worked with the Natural Resource Defense Council. Environmental Defense Fund, National Electrical Manu facturers Association, and the Edison Elec tric Institute/Utility Solid Waste Activities Group. This consensus group successfully argued that a rule be issued under TSCA Section 6. alongside other PCB specific regu lations rather than under RCRA as Congress had contemplated. The group convinced Congress that a RCRA rule would be costly and potentially confusing without the bene fit of significant improvement in addressing the stated concerns.
The Panel formed to represent the interests of the industry during implementation of the TSCA Section 6 regulations for the control of PCBs, mitigation of transformer fires, and
retention of electrical equipment containing PCBs.
The Panel will continue to monitor new and existing PCB issues relating to SARA, EPA drinking water criteria issues, and the cleanup of accidental and old spills, including RCRA and Superfund proposals. Panel actions to address individual state PCB regulatory ac tivities are expected to increase in the com ing year.
Rubber Additives
1
DATE CHARTERED:
1979
CURRENT TASK GROUPS: Toxicology Research MBT MBT Joint Test Sponsors/
I CHAIRMAN: Bernard Hill
Monsanto
Importers of Rubber Articles Company
PANEL MANAGER: Susan Howe
The Panel completed most of the studies on 2-mercaptobenzothiazole required under the TSCA Section 4 Test Rule. The reproduc tive effects studies will be completed bv fall 1990. The Panel is now preparing a lay man's summary of each of the studies per formed under the Test Rule. This will be used to disseminate the test results to the joint test sponsors/importers of rubber ar ticles containing MBT.
The Panel formed to support research that would expand the rubber additives safety and health issues data base. To date, the Panel has collected information on approxi mately 65 chemicals classified as rubber additives, and has sponsored more than $800,000 in research.
The Panel will continue to collaborate with the German consortium, WTR, in efforts to monitor, review, and sponsor health and safety studies on rubber additives. Panel members are working to establish a dialogue between the ITC and industry in developing a sufficient database for rubber additives listed as priority chemicals by ITC.
23 CMA 030634
Specialty Acrylates/ Methacrylates
DATE CHARTERED: 1987
CURRENT TASK C'.ROL PS
CHAIRMAN.
Scientific Issues Membership Regulatory Issues
Georjean Adams Minnesota Minina and Manufacturing Compans
Titanium Dioxide
date chartered. 1977
CLRRENTTASKGROLPS. None
PANEL MANAGER. Jonathon Busch
CHAIRMAN: Jerry Blacker SCM Corporation
tions in states that have added, or plan to add. titanium dioxide to their hazardous sub stances lists and will petition for delisting where necessary.
panel manager. Manan Stanley
The Panel reached agreement with EPA on revisions in some of the more restrictive pro visions of the TSCA Section 5 consent orders for new acrylates. Prior to the agreement, manufacturers were required to label all new acrylates and methacrylates as potential car cinogens based upon structure-activity rela tionships to existing chemicals. This and other provisions of the orders restricted distri bution and impeded successful marketing. In addition, the Panel was successful in reaching an agreement with the Agency concerning existing consent orders. Member companies were able to replace the restrictive language in their existing consent orders with the new ne gotiated language.
In January 1989, EPA published a Notice of Proposed Rulemaking setting the ReportableQuantityforTiCIjat 1 lb. InAugust.the Agency published another NPR raising the RQ for Ticino 100 lbs. The Panel submitted comments to the Agency in both instances requesting that EPA set the RQ at 1000 lbs. in the Agency's final rule under CERCLA designating TiCl4 as a hazardous substance. The EPA response to the Panel's comments is expected m November 1990.
The Panel submitted an epidemiology study on TiClj workers to the National Cancer Institute. The Panel also submitted scien tific comments to the publisher Van Nos trand Reinhold and as a result was success ful in having the hazard rating for titanium dioxide lowered in Dangerous Properties of Industrial Materials, Sax and Lewis (eds.).
The Panel formed to address EPA concerns about new and existing specialty acrylates and methacrylates. The Panel's major em phasis is on working with the Agency to remove restrictions on the development and marketing of new products. Current Panel membership consists of producers, importers, formulators. and users of these chemicals.
The Panel continued information-sharing sessions in which member company repre sentatives discuss case histories of acciden tal releases and safety problems encountered with TiClr The companies hope to enhance worker and community safety by sharing key experiences and improvements made to control releases.
The Panel has begun to conduct the first tier of toxicological tests in the three-stage research program agreed upon with the EPA. The Panel will continue working with EPA to remove distribution restrictions on these important new chemical products.
The Panel formed to address concerns about the potential hazards confronting workers in complex atmospheres created during formu lation operations w ith titanium dioxide.
The Panel plans to monitor proposed regula tions on mining wastes and to assess the impact of those regulations on the titanium dioxide industry The Panel has tentative plans to submit a S ARA Section 313 delist ing petition to EPA tor carbonyl sulfide, and will address other issues such as SARA Sec tion 110 actions and TiCI4 airborne release modeling. The Panel also will track regula-
24 CMA 030635
Trimellitate Esters
Vinylidene
mil) Chloride
Water Additives
DATE CHARTERED: 1983
DATE CHARTERED' 1974
DATE CHARTERED: 1985
CURRENT TASK GROUP Toxicology Research
PANEL MANAGER Elizabeth Moran
CHAIRMAN: Dean Finney
Eastman Chemical Company
The Panel completed a battery of environ mental and health effects tests on tri-2-ethylhexyl trimellitate as parr of a Negotiated Testing Agreement under TSCA Section 4. In 1990. the Panel added terephthalic acid to the scope of its activities. The Panel submit ted comments in support of the proposed delisting of terephthalic acid from SARA 313. In its proposal. EPA indicated that delisting would await additional testing under TSCA Section 4. The Panel opposed linking delisting to a TSCA Section 4 testing re quirement.
The ITC designated the trimellitate ester for priority testing under TSCA Section 4 in 1982. The recommended testing included metabolism, subchronic, mutagenicity, and environmental effects testing. The produc ers immediately formed a special task group under the Phthalate Esters Panel and subse quently formed the Panel to pursue a nego tiated testing agreement. The Panel reached an agreement with EPA in 1984.
When EPA completes its review, the Panel will work with Agency scientists to interpret the test data and to determine the need for additional testing.
CURRENT TASK GROUPS: None
PANEL MANAGER Jonathon Busch
CHAIRMAN, Zeb Bell
PPG Industries, Inc
The Panel continued its efforts to have EPA withdraw the proposed TSCA Section 4 test rule. The Office of AirQuality Planning and Standards has stated that further testing of VDC is unnecessary. Nonetheless, the EPA Test Rules Development Branch will not withdraw the rule until ATSDR has evalu ated and published the final Toxicological Profile on VDC under SARA Section 110. The Panel submitted comments to ATSDR on VDC as part of its continuing effort to assist the Agency in evaluating the chemi cal. The Panel also submitted comments to ATSDR on 1,2-dichloroethene. a by-prod uct of VDC production.
The Panel formed to sponsor research on the potential toxicologic effects and pharma cokinetics of VDC. The objective was to develop data for ensuring the safety of work ers involved in the manufacture, handling, and use of the chemical, as well as the safety of communities surrounding production fa cilities.
The Panel will continue to work with ATSDR and EPA to achieve reasonable regulations based on sound scientific information.
CURRENT TASK GROUPS: Specific Chemicals Exposure Toxicology
CHAIRMAN. Paul Carlson
Calgon Corporation
PANEL MANAGER Robert Romano
The Panel has focused on filling data gaps for ultimate certification under the consen sus Water Additives Standards. The Panel began addressing data needs for the follow ing chemicals: polydiallyldimethylammonium chloride (PDADMAC), copolymers of epichlorohydnn and dimethylamine (EPI/ DMA), and polyacrylamide (PAM), The Panel formed a task group for each of these chemicals which will perform an exposure assessment and sponsor tests. The toxico logical tests to be performed will include Ames, rat micronucleus, rat teratology, and 90-day subchronic.
The Panel formed to address regulations of direct and indirect potable water additives. The objectives are to monitor regulatory policies, improve communication, review toxicology data, develop advocacy positions, ensure that any water additives program is designed and administered in a cost-effec tive manner, and ensure that water additives are used in a manner that does not compro mise public health, safety, or the environ ment.
The Panel will continue to work with all organizations that are developing water ad ditive certification programs. The Panel also will participate in American Water Works Association activities where these programs will be discussed further and de fined. The Panel will officially meet with each of the three certification agents and their toxicology staffs in 1990. Certification packages for the three chemicals will be developed for use by each member com pany. with ultimate certification by the agent of their choice.
25 CMA 030636
COMPLETED PANELS
he manufacturers ofaromatic diamines. 2-ethylhexanoic acid, and vinyl chloride disbanded their groups this
Jyear The aromatic diamines manufacturers discovered that they have diverse product lines and diverging research goals: 2-ethylhe.xanoic acid manufacturers reconstituted the group to include chemicals involved in the oxo process: and the vinyl chloride group completed its research goals.
Aromatic Diamines
DATE CHARTERED, 1987
CURRENT TASK GROUP: Toxicology Research
PANEL MANAGER: Carol Stack
chairman
Robert Smith Eth\I Corporation
2-Ethylhexanoic Acid
DATE CHARTERED1984
CURRENTTASK GROUP: Toxicology Research
PANEL MANAGER. Has Shah
Vinyl Chloride
DATE CHARTERED1973
CHAIRMANRoderick Gerwe Eastman Kodak
Company
CURRENT TASK GROUP: Research Coordinator
PANEL MANAGER Susan Howe
CHAIRMANWilliam Gal'fey Monsanto Company
No new activities were undertaken by the Panel this year. Previous activity included the investigation of research to identify dif ferences in biological activity of substituted aromatic diamines.
The Panel formed to develop a strategy ac ceptable to EPA for achieving PMN approv als without a long-term bioassay on each new product. Currently, very limited struc ture-activity data exist to refute the Agency's assumption that all substituted aromatic di amines are potentially carcinogenic.
The Panel decided to terminate in March. Diversity in the aromatic diamines product lines among Panel members and consequent divergences in research interests did not permit development of a program that could adequately address all Panel members' needs.
The Panel decided to merge with the 2-EthyIhexanol Panel and its Butyraldehyde Task Group to form a panel including chemicals involved in the oxo process. The merger will enable the reconstituted panel to address issues on a broader range of chemicals that are starting materials, intermediates, or the end products of the oxo process.
The Panel formed following the Interagency Testing Committee's designation of 2-ethylhexanoic acid for priority testing under TSCA Section 4. The Panel submitted data to EPA documenting the uses and manufac turing processes associated with the chemi cal. Since EHA is used solely as a chemical intermediate and is manufactured and proc essed in a closed system, the Panel focused on demonstrating that there is no significant human exposure. EPA published a final test rule for EHA in 1986. The required testing was completed by the Panel in 1988 and final reports were submitted to the Agency for review.
Panel activities included the update of the 1974 Panel-sponsored epidemiologic study on vinyl chloride workers. Activities also included the unsuccessful attempts to deter mine what proportion of the non-angiosarcomas and biliary tract tumors were really misdiagnosed angiosarcomas.
The Panel formed to accumulate and assess health and safety data on vinyl chloride monomer. After funding several animal studies, emphasis on research shifted from toxicological investigations to early diagno sis and clinical management of injuries. Sub sequently, the Panel has focused on epi demiologic studies of workers. The Panel completed its research goals and decided to terminate activities in 1990.
Future activities involving EHA will be conducted under the reconstituted panel and will depend upon the EPA response to data submitted under the test rule.
CMA 030637
26
Table 1
CHEMSTAR PANELS FINANCIAL STATUS
For the Twelve Months Ended May 31. 1990
Panels
Acrylates/Methacry lates Alkanolamines Aik ylphenols/Ethoxy latex Aromatic Diamines Arsenic Benzene Biocides Brominated Flame Retardants Butadiene Butylated Hydroxytoluene Chlorinated Pool Chemicals Chlorine Dioxide Chlorobenzenes Cobalt Cresols Crystalline Silica Cumene Cyclohexane Dibenzofurans/Dibenzodioxins Dinitroluenes Epoxy Resins Ethylene Dtbromide Ethylene Dichloride Ethylene Glycol Ethylene Oxide Ethylhexanol Ethylhexanoic Acid Fluoroalkenes Fluorocarbons Glycol Ethers Hexamethylene Diisocyanate Hydrofluoric Acid Hydroquinone/Quinone Isocyanates Isopropanol Ketones Lubricant Additives Metal-Containing Catalysts Methylenedianiline Naphthenates Oleylamme Phenol Phosgene Phthalate Esters Polychlorinated Biphenyls Potable Water Additives Rubber Additives Titanium Dioxide Trimellitate Esters Vinyl Chloride Vinylidene Chloride
Balance June 1. 1989
S284.900 39,100
372.300 1.100 3.300
447,300 781.800
0 114.900 36.700
0 (13.100) 466.200
0 330,600
19,800 434,000
4.100 13.700
0 400
0 (3.800) 203.900 235.100 562,500 38.900 422.500 2.358.400 728.700 11,800
7.200 86.600 88,600 221.400 (54,800) 37.100 66.200 50.600
100 100,000 30.000 221.100 859.100 109.700
6,600 111.400 24.300
18.800 31.100 (21.900)
$9.888,500
Contribution Receipts
S5 70.000 0
376,300 0 0 0
774.900 41.100
393.900 20.000 100.000 163,000
454.800 40,000 68.900 154.000
696.600 80.000 37.500
251,600 0 0
10.800 44.700 30.900 1.072.400
3.700 352.600 150,000 620.200
0 32.800
0 90.000 844.600 415.000
5,100 67.000 52.000
0 26.000 56.500 71.200 1.010,900 13.000 442.000 486.600 31.000 30.000
0 85,000
SI 0.266.600
27
Interest Revenue
547,000 3,000
29.000 100 100
37.100 68,600
100 11,000 2.600
1,400 1.200 39,900
900 14,100 4.900 36.700 2.500
1.300 9.600
0 0 300 14,900 15.700 97,900 3.500 33.600 150.100 46.900 400 600 4.900 4.000 38,700 11.100 3.200 3.300 5.700 0 4,900 2.300 18.600 98.700 8.500 7,600 19.600 1.000 1.700 2.500 2,700
S914,000
Expenditures
SI 07.800 19.600
289,800 1.200 2.800
85.700 789.500
19.300 367,900
27.000 80,600 119,800 277.700 19.300 369,300 110.100 814.100 67.100 42.300 106,100
400 0
2.400 158.600 170,800 381.300
4.000 469,100 1.587,900 804.300
11.800 18.200 71,300 127.200 426.000 164.300 11.900 107,000 55.000
100 118.500 56.900 118.300 609.100 72.500 29.800 394.900 46.500
8.400 7.600 22.000
$9,773,200
Balance
May 31.1990
S794.100 22.500
487.900 0
600 398.700 835.800
21,900 151.900 32.300 20.800 31.300 683.200 21.600 44.300 68.600 353.200
19,500 10.200 155,100
0 0 4.900 104,900 110.900 1.351.500 42.100 339.600 1.070.600 591.500 400 22,400 20,200 55.400 678,700 207,000 33.500 29,500 53.300 0 12.400 31.900 192,600 1.359.600 58,700 426.400 222.700 9.800 42,100 26.000 43.800
511.295.900
CMA 030638
FINANCIAL RESOURCES
ach panel is required to maintain a CASH COMPENSATING BALANCE which recognizes that CMA signs all contracts on behalfof the panels and assumes thefinancial liabilityfor panels meeting their contractual commitments. The balance permits timely honoring offinancial commitments. The combined compensating balance for all CHEMSTAR Panels at the beginning of Fiscal Year '89-90 w as about SIO million. Compensat ing balances on May 31.1990 totalled about SI l million. On this date. CMA hadfinancial liabilities totalling about SIO million under 215 executed contracts on behalf of the various panels. INTEREST on the unexpended cash balance provides supplemental revenue for each CHEMSTAR Panel. This year, panels earned a combined total ofS9l4 thousand in interest income. EXPENDITURES ofCHEMSTAR Panels are based on budgets approved by each panel. In Fiscal Year '8990. panels spent a collective total of $9.8 million for research, consultants, legal counsel and panel management.
Figure 1
CHEMSTAR PANELS Financial Allocations
RESEARCH 60%
ADVOCACY 40%
FY 1987-88
FY 1988-89 25%
B"
CMA 03063?
28
Figure 2
CHEMSTAR PANELS Submissions to Government Agencies
400 C/5 300 z 0
35
00
1 200
a: D
C/5
100 0 '80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90
YEAR
29 CMA 0306-40
REGULATORY AFFAIRS
mn 1989-90, 44 CHEMSTAR panels directly addressed regulatory issues. Panels as usual submitted A. comments on pending regulations and research data to a wide variety offederal, state and international agencies.
Greatest attention amongfederal agencies went to EPA. TSCA Section 4 testing is the principal concern of 21 panels. Panels ever morefrequently addressed FIFRA concerns. Otherfederal agencies that panels inter acted with during the year were the Occupational Safety and Flealth Administration, National Toxicology Program, and the Food and Drug Administration.
Stare agencies commanded much greater attention. The California Department ofFood and Agriculture attracted the most activity' due to Proposition 65 implementation and data call-ins on industrial chemicals. In the international area, the United Nations Environment Programme, Organization for Economic Cooperation and Development, US Department of State, and the Food and Agriculture Organization/World Health Organization were principal focuses.
Figure 3
CHEMSTAR DIVISION Staff Time Allocations
Advocacy
Research
cm 030641
39
Research Meetings: Biocides Panel Butadiene Panel Chlorinated Pool Chemicals Panel
Figure 4
CHEMSTAR PANELS Summary of Research Expenditures
Epidemiology
$70,000
Environmental
Toxicology
Exposure Surveys
Risk Assessment
^^^150^00^
Atmospheric Clinical
31:
________________ $55,000
wjmmmjoJ
}}
I$540,000
$4,000,0001
$600,000 |
CMA 030642
RESEARCH
Mjorty CHEMSTAR Panels sponsored someform ofresearch. The trend this year was towardfewer, hut larger. A- projects.
Health effects studies were a majorfocus. Toxicological research involved subchronic/chronic, mutagen icity. teratogenicity, oncogenicity and pharmacokinetic studies. Direct effects on humans were investigated by several panels through epidemiology and clinical research. Risk assessments and exposure surveys were other forms ofresearch undertaken by nearly a quarter ofall CHEMSTAR Panels. Environmental studies continued this sear with larger budgets, reflecting greater interest in air and water regulations, in particular.
Testing required under TSCA Section 4 was initiated by several CHEMSTAR Panels. Mainly, the tests are large-scale efforts lasting several years. The testing schemes include many decision points where EPA and industry scientists must interpret data and decide on next steps.
As in the past, some Panels undertook studies simply because ofresearch findings rather than direct regu lators concerns. "Proactive" research continues to be a significant part of CHEMSTAR Panels' scientific efforts.
Ftgure5
CHEMSTAR DIVISION Summary of Contracts Managed
300
250
200
5 150 <
50
0
'80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90
YEAR
CMA 0306-43
GUIDANCE
HEMSTAR Policy Committee Purpose: The Committee ensures that all CHEMSTAR Panels and Business
CCouncils are conducted in a manner consistent with Association policy, and with the CHEMSTAR Guidelines: counsels with the panels and councils regarding new and revised operating needs: and, reviews and makes recommendations on advocacy activities when requested by a panel, council or staff.
CHEMSTAR Policy Committee
CHAIRMAN' Earnest W. Deavenport, Jr. Eastman Kodak Company
VICE CHAIRMAN Ernest Drew Hoechst-Celanese Corporation
v*
Geraldine V. Cox Vice President-
Technical Director CMA
STAFF EXECUTIVE. Langley A. Spurlock Director. CHEMSTAR CMA
Division
33
Gary C. Herrman Vice President-
Treasurer CMA
David F. Zoll Vice President-
General Counsel CMA
CMA 030644
MANAGEMENT SERVICES
j issues, objectives and locations of effort grow, management of the CHEMSTAR Panels and Business
ACouncils becomes ever more challengingforpanel, council and task group chairmen. This vear .as in the past a broad array of CMA services was employed to ensure that panels and the new council receive adecpiate support for their operations.
Leadership Training
The annual CHEMSTAR Leadership Ses sion was held in November, and attended by ten panel leaders. The Sessions are designed to assist chairmen in resolving the dilemmas of leading diverse and changing organiza tions. Sessions are invitational, one-day workshops primarily held for new panel and task group chairmen. Participation by expe rienced chairmen also is welcome and sought. At the Sessions, a training specialist from a CMA member company provides advice on persuasive leadership, and peers share expe riences in dealing with related problems. Because participant ratings continue to be high, another Session is planned for fall 1990.
Communications
Ensuring industry awareness of panel activi ties and other important specific chemical regulatory and research developments re mained a high priority for the CHEMSTAR Division, CHEMSTAR NEWS, a quarterly publication with a circulation of 1.500, is the Division's principal means of reaching a broad industry segment. The NEWS points out upcoming regulatory impacts on specific chemicals, summarizes recent actions of various panels, lists panel reports and agency submissions, and highlights significant changes in panel membership. Through the "Spotlight" article in each issue, the accom plishments of individual panels are summa rized. This year, the Chlorobenzenes. Viny lidene Chloride. Ethylhexanoic Acid, and Oleylamine Panels were featured.
34
CMA 030645
The CHEMSTAR Alerts, published as needed, are the Division's means of quickly informing panel members and others in the industry when a time-sensitive response is needed on a chemical-specific issue. Sub jects in Alerts vary from a pressing need to submit information to an agency, to the need for joining other companies in a response to a regulatory deadline. In 1989-90. the Divi sion issued two Alerts -- one on Reportable Quantities under SARA Title III Section 302 and CERCLA Section 102; and the other on OSHA regulation of nitrosamines.
DIRECTOR, CHEMSTAR DIVISION
Langley A. Spurlock, Ph.D,, CAE
Dr. Spurlock completed his eighth year as Director of the CHEMSTAR Division in June. He is responsible for oversight of all panels and councils, and for management of the Total Quality Council.
Division Staff
The CHEMSTAR Division responded to this year's increase in panel activities by ex panding the management staff and assigning new responsibilities to existing managers. Marian Stanley filled a newly created posi tion as Panel Manager, bringing the manag ing staff to eleven persons, all with technical degrees.
Jonathon Busch also joined the managing staff this year as Senior Panel Manager, replacing Henry Sauer who was promoted to Director of CMA's National Chemical Re sponse and Information Center. Bob Toro resigned in April. In recognition of her superior achievements, Elizabeth Gormley was promoted to Associate Director within the CHEMSTAR Division. Likewise, Bar bara Francis was promoted to Senior Panel Manager because qf her excellent accom plishments.
In further recognitions, at year's end, Lan gley Spurlock was promoted to CMA Dep uty Technical Director and CHEMSTAR Division Director. Has Shah and Carol Stack were then promoted to the newly cre ated positions of Director. CHEMSTAR Pan els.
Dr. Spurlock is a Certified Association Ex ecutive, awarded by the American Society of Association Executives. Before joining CMA, he held an appointment in the US Government Senior Executive Service at the National Science Foundation. During his tenure at NSF he served as Senior Staff As sociate for Operations, Directorate for Mathe matical and Physical Sciences, Special As sistant to the Director, Office of Planning Resources Management, and as Oversight Coordinator and Special Assistant to the Director, Office of Audit and Oversight. Previously, Dr. Spurlock received an ap pointment as US Department of Health, Edu cation and Welfare Fellow, and served as Special Assistant in the Immediate Office of the Secretary of HEW. Earlier, he was As sistant to the President at the American Council on Education. Before coming to Washington, Dr. Spurlock held an appoint ment as Associate Professor of Chemistry at Brown University and earlier was Assistant Professor of Chemistry at Temple Univer sity. Previously he served as Senior Re search Chemist in the General Chemical and Agricultural Chemical Divisions of Allied Corporation. Dr. Spurlock received a Ph.D. in Organic Chemistry from Wayne State University.
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DIRECTORS, CHEMSTAR PANELS
Hasmukh C. Shah, Ph.D., D.A.B.T.
Carol R. Stack, Ph.D.
Dr. Shah joined CMA and the CHEMSTAR Division in 1979. He is responsible for the management of the Biocides. Brominated Flame Retardants. Ethylene Dichloride. Ethylhexanoic Acid. 2-Ethylhexanol. and Naphthenates Panels.
Dr. Shah is a Board Certified Toxicologist. Before coming to CMA. he was the Director of the Toxicology and Biomedical Sciences Department of Equitable Environmental Health. He was also the Project Director for the National Institute for Occupational Safety and Health's criteria document project, and for the "Profiles on Occupational Hazards for Criteria Document Priorities." Earlier, at the Stanford Research Institute, Dr. Shah was a Project Coordinator, and he served as a Senior Toxicologist. Previously, he was a Visiting Fellow Scientist at the National Institute for Environmental Health Sciences. Dr. Shah received a Ph.D. in Pharmacology and Toxicology from the University of Rhode Island.
Dr. Stackjoined CMA and the CHEMSTAR Division in 1980 and was promoted to Asso ciate Director in 1985. She is currently re sponsible for management of the panels on benzene, chlorobenzenes, ethylene glycol, glycol ethers, lubricant additives, and hexamethylene diisocyanate.
Before joining CMA. Dr. Stack was em ployed in the Toxicology and Biomedical Sciences Department at Equitable Environ mental Health where she served as an Assis tant Project Director responsible for the preparation of NIOSH multi-chemical crite ria documents. Earlier, she served as Visit ing Scientist at the Neurological Institute in Bogota, Colombia, where she investigated central auditory pathways in echolocating birds. Dr. Stack received a Ph.D. in Biology from New York University.
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ASSOCIATE DIRECTORS
Elizabeth Festa Gormley, B.A.
Engineering Professor at George Washing ton University and teaches courses m envi ronmental management and program man agement. He received a Ph.D. in Environ mental Sciences and Engineering from Pur due University.
SENIOR PANEL MANAGERS
Jonathon Busch, MBA
Vis. Festa Gormley joined CV1A and the CHEMSTAR Division in 1983. She is re sponsible tor the management ot the Fluoro carbons. dibenzofurans/dibenzodioxins, polychlorinated biphenyls, hydrogen fluo ride, and crystalline silica panels.
Prior to joining CMA. she was Section Staff Executive with the National Electrical Manu facturers Association, where she was re sponsible for the Nuclear Magnetic Reso nance Imaging Section with the Diagnostic Imaging and Therapy Systems Division. Previously, Ms. Festa Gormley worked in the Endocrine Biochemistry section of the National Institute of Arthritis and Metabolic Disease at the National Institutes of Health, and held the position of Research Chemist at both CENTEC Corporation and Radian Cor poration. She was also a recipient of a National Science Foundation Assistantship, Ms. Festa Gormley earned a B.A. In Chem istry from Albertus Magnus College.
Robert R. Romano, Ph.D.
Dr. Romano joined CMA in 1980 as a man ager in the Environmental Division where he w as responsible for the water and air pro grams. In February 1985. he joined the CHEMSTAR Division as an Associate Di rector. He continued this year as manager of the programs on chlorine dioxide, diisocy anates. ethylene dibromide, ethylene oxide, phosgene and water additives. Recently he also assumed management of the Alkylphenols and Ethoxylates Panel.
Dr. Romano came to CMA from the US Nuclear Regulatory Commission, where he worked as an Associate Project Director. Previously he worked on a school fluorida tion project for the Indiana State Board of Health. He has also taught at Del Mar Col lege and American University. Presently, Dr. Romano is an adjunct Environmental
Elizabeth J. Moran, Ph.D., D.A.B.T.
Dr. Moran joined CMA and the CHEM STAR Division in 1981. She continued this year as manager of the panels on butadiene, methylenediamline, phthalate esters, spe cialty acrylates/methacrylates, and trimellitate esters.
Dr. Moran is a biochemist and Board Certi fied Toxicologist. She is currently on the Editorial Board of the Journal of Toxicology and Environmental Health, and on the coun cil of the American College of Toxicology. Before coming to CMA. she was a program manager at JRB Associates. Earlier, Dr. Moran directed the Flavor Safety Program at International Flavors and Fragrances, Inc., where she was responsible for toxicological testing on new chemicals. Previously, Dr. Moran conducted lipid nutrition research at the US Department of Agriculture and was a visiting professor at the University of Mary land. Dr. Moran received a Ph.D. in Bio chemistry from the University of Maryland.
Mr. Busch joined CMA and the CHEM STAR Division in April 1990, He is respon sible for the management of panels on alkanolamines, cyclohexane, hydroquinone. titanium dioxide, tluoroalkenes, and vinylidene chloride. He also has been in volved in activities of the newly formed Methyl Bromide and Sodium Bromide Pan els.
Prior to joining CMA, Mr. Busch was a Senior Associate with ICF-CIement Associ ates, a health and environmental sciences consulting firm. Previously, he was Senior Science Analyst with the Cosmetic Toiletry and Fragrance Association.
Mr. Busch holds an M.B.A. degree in Fi nance from George Mason University and a B.S. degree in Biology from Virginia Poly technic Institute and State University.
Barbara O. Francis, MBA
Ms. Francis joined CMA and the CHEM STAR Division staff in March 1989. She is responsible for the management of the pan els on cumene, cresols, dinitrotoluenes. ketones, chlorinated pool chemicals and isopropanol.
Before joining CMA. Ms. Francis was with Interspan Inc., a management consulting firm. Previously, she held the position of product planner for Hoechst Celanese, Inc. and also served as a translator for the US Air Force in Europe. Ms. Francis holds an M.B.A. from Virginia Polytechnic Institute and State University and a B.S. in biology and chemistry from Bishop's University in Quebec, Canada.
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Susan R. Howe, M.S.
\(s. Howe joined CMA and the CHEMSTAR Division staff in June 1989. She is re sponsible for the management of the butylated hydroxytoluene, cobalt, metal catalysts, nitrosamines. oleylamine, phenol, rubber additives and vinyl chloride panels.
Before coming to CMA. Ms. Howe was a Product Safety Representative for the Mobay Corporation. Previously, she was a Regula tory Specialist with Ruetgers-Nease Chemi cal Company. Ms. Howe holds an M.S. degree in Food Science and a B. A. in Sci ence from the Pennsylvania State Univer sity.
PANEL MANAGER
Marian K. Stanley, MBA
Ms. Stanley joined CMA and the CHEMSTAR Division staff in May 1990. She is responsible for the management of the panel on Specialty Acrylates/Methacrylates. She also manages the Phthalate Esters Environ mental and Toxicology Research Task Groups.
Legal Counsel
The panels and councils were strongly as sisted by the CMA Legal Department in antitrust, contract, research and regulatory areas. Reflecting the importance and com plexity of their issues, a CMA attorney is assigned full-time to the affairs of CHEMSTAR. To ensure that antitrust protection is consistently maintained, CMA attorneys counseled panel and council chairmen, as well as Division staff on proper procedures. As usual, staff attorneys reviewed all panel and council comments, contracts, reports, agendas, and minutes as part of routine pro tective measures. In research, the assigned CMA counsel intensively supported Divi sion managers in drafting and negotiating the nearly 250 contracts awarded this year to laboratories and consultants. In advocacy, the CMA counsel supervised the activities of outside counsels retained by the panels and councils. The CMA counsel provided ad vice on regulatory activities and ensured that member company legal counsels were in formed of significant developments.
ASSISTANT
GENERAL COUNSEL
Marilyn D. Browning, J.D.
Ms. Browning joined the CMA Legal De partment in 1987 as the staff attorney for CHEMSTAR Panels and Councils. Ms. Browning reviews and provides counsel for drafting of all substantive panel and council documents including contracts, regulatory comments, legislative correspondence and testimony, filings in litigation, and press re leases. In addition, she counsels panel and council members and staff on antitrust pre vention and supervises their outside attor neys. She also serves as counsel to the Chemical Control Task Group of the CMA International Affairs Committee.
Before coming to CMA, Ms. Browning was in private practice with Augustine and Kern Ltd. of Chicago, representing private and corporate clients. Prior to her legal career, Ms. Browning owned and managed a serv ice agency specializing in fashion advertis ing. Earlier she was an instructor of grades K-9. Ms. Browning is a member of the Illi nois and District of Columbia Bars. She holds a B.S. from the University of Illinois and a J.D. from the Illinois Institute of Tech nology, Chicago Kent College of Law.
Prior to joining CMA. Ms. Stanley was a Technical Project Manager with Squibbmark. Previously, she was employed as both a development and analytical chem ist at Union Carbide Corporation.
Ms. Stanley holds an MBA in Pharmaceuti cal Studies from Fairleigh Dickinson Uni versity. and a B.S. in Chemistry from Pratt Institute.
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DIVISION MANAGERS
From left to rvjht: F.ltzahcth (jot mles. Susan How e. F.lnahclli Moran. Hasniukh Shall. Carol Stack, l.atriles Spurlock. Bill hara Front is Jonathon Bust h. Manan Shinies. and Rohm t Romano
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