UNITED STATES ENVIRCT^CNTAL PROTECTION AGENCY Region II, Nev York, New York 10271 DATE : January 13, 1989 SUBJECT: Risk Assessment Review JZ ' FRCM: wrri i ğm/j .'^tJj^ynsk i Deputy RegionaI Administrator .KiUum Peter Preuss Director Office of Regulatory Support and Scientific Assessment Attached is a copy of the Risk Assessment Review, a bimonthly publication that is a cooperative effort between the Office of Research and Development and the Regional Risk Assessment Ne two rk. The Review serves as a focal point for information exchange among the EPA risk assessment community on both technical and policy issues related to risk assessment. It is currently in its second year of publication, and we are pleased at the positive feedback we've received on the Review's usefulness to staff across the Agency. Thanks to all of you who continue to contribute articles and are involved with production efforts. If you have an article to contribute or any suggestions for future issues, contact one of the Cooxsittee members listed on page I of the review. At t achment ------- December 1988 Highlights Updates for Risk Communication Project List p. 1 Forum Colloquium on Metals Bioavailability p. 1 Risk Assessment Forum Activities p. 2 BEIR IV Report on Radon Available p. 2 Fourth Risk Assessment Meeting Seattle, WA p. 4 Seventh Symposium on Methods for Environmental Quantitative Risk Assessment p. 4 I. Special Features Updates for Risk Communication Project List by Ann Fisher (FTS 382-5500) The October 1988 Risk Assessment Review listed the members of the Intra-Agency Risk Communication Workgroup. It also updated the October 1987 list of risk communication projects in the "problem-specific consulting and analysis" category. Below is an update of the skills-building activities. The contact person listed for a topic can provide more information about its current status. Call Ann Fisher (FTS 382-5500) or Derry Allen (FTS 382-4012) for general information about the Agency's Risk Communication Program (RCP). Forthcoming issues of RAR will update the other two components of the RCP. The entire list is available on the E-mail Risk Assessment/Risk Management Bulletin Board. (Once in E-Mail, type "PRPOST" at the > prompt and "RISK" when asked for a category.) Risk Communication Training Activities Ongoing 1. Risk and Decision Making - introductory course on the assessment, management, and communication of risk. It began in the fall of 1987, and 3000 EPA staffers have attended so far. (Mary Setnicar, FTS 382-2747) 2. Risk Communication Training - second level course. About 50 people have been through three "dry runs," leading to improvements for the final version. Facilitator training is planned for early 1989. States have expressed interest in using the course. (Derry Allen, FTS 382-4012) 3. Risk Communication Training - four-hour course for Superfund site managers, based on case study results in Region I. First offered May 1988 and periodically thereafter. (Sally Edwards, FTS 835- 2993) 4. Community Environmental Risk Training - The University of Texas is developing a manual and "train-the-trainers" course for public officials to use in communicating with communities about toxic chemicals in a local environment. Such chemicals might be in Superfund sites or revealed by Title III of SARA. (Ann Fisher, FTS 382-5500; Dorothy McManus, FTS 475-8600; Mike Stahl, FTS 382- 3790). Risk Assessment Review Committee Peter Preuss - ORD, FTS 382-7669 Sally Edwards - Region I, FTS 835-3387 Maria Pavlova - Region II, FTS 264-0764 Marian Olsen - Region II, FTS 264-5682 Suzanne Wuerthele - Region VIII, FTS 564-1714 Dana Davoli - Region X, FTS 399-2135 5. Putting Environmental Risks in Perspective - booklet explaining in everyday terms how risk assessment yields a risk estimate at the community level. Comparison of risk estimates for several environmental issues, especially as related to a) Superfund, b) Title III, and c) risks the individual can mitigate. Initiated 8/88, with OSWER. (Ann Fisher, FTS 382-5500; Dorothy McManus, FTS 475- 8606) Proposed 6. Risk Communication Manual - to draw from existing specialized risk communication materials and develop a general manual for communicating about environmental risks. (Derry Allen, FTS 382- 4012) 7. Risk Communication Training for Young People - to work with junior-high students in developing computer modules about various environmental risks; potentially to work with National Geographie s initiative to improve pupils' understanding of geography and related issues. (Ann Fisher, FTS 382-5500) Forum Colloquium on Metals Bioavailability By Suzanne Wuerthele (FTS %64-T7t4) On December 7th and 8th the Risk Assessment Forum held a colloquium on "Assessing the Bioavailability of Lead and Other Metals." As with other colloquia, this meeting was called to exchange scientific information and to identify and summarize the current issues on the topic for referral to the Forum. There is also an opportunity for colloquia to recommend that the Forum study certain issues, if appropriate, which this colloquium will do. This colloquium is not designed to resolve issues or develop "answers" to the questions presented. Rather, it is intended to provide a forum for Agency staff to discuss current approaches to assessing bioavailability, to review the current knowledge base, and to identify key areas for further research. Thus, it is just the first step in Forum discussion and analysis of this issue, and no scientific conclusions were expected or reached. The Forum and the Risk Assessment Council will discuss whether or not the Forum does additional work. Risk assessors are well aware of the controversy over how much soil a child ingests. Paul White (ORD/OHEA, FTS 382-2584) described experiments underway to measure children's soil ingestion with the use of tracer elements. Lisa Ratcliff and Marlene Berg (FTS 382- 4781) described OSWER's current efforts to develop 1 ------- soil ingestion rates guidance, which will include an attempt to reconcile more than eight different values currently published in documents issued at different times by different EPA offices. OSWER is also working on developing an RfD for lead. Suzanne Wuerthele (Rjgion VIII, FTS 564-1714) summarized her poll of Regional risk assessors on metals issues. Regions asked (1) for a summary of the current science on metals, particularly lead; (2) for guidance from headquarters on issues such as "acceptable" blood lead values, soil ingestion rates, bioavailability of various metals, analytical methods and the appropriate use of clinical data at Superfund sites; (3) for an RfD for lead; and (4) that the Forum recommend research into these areas. Representatives of several groups presented method- ologies for assessing exposure and bioavailability: Jeff Cohen (OAQPS, FTS 629-5282) described models for estimating blood lead under various exposure scenarios. A biokinetic model, which takes age-specific intakes and absorption as well as pharmacokinetic data into account currently appears to be most useful for estimating blood leads up to about 35 iig/dl. Jeff believes this model can help regional risk assessors and has invited our questions. Raleigh Farlow, a contractor working with Region X, described the risk assessment approach being used at the Bunker Hill site in Kellog, Idaho. In this approach, a baseline exposure for a "typical" population is first established, then incremental exposures associated with activities such as eating local fish or ingesting large amounts of soil are identified. Contact Dana Davoli (FTS 399-2135) for further information. Stephanie Irene (OSW, FTS 382-5219) described an ongoing animal study designed to measure bioavailability of cadmium from soil and water. OSW is planning similar studies for selenium, mercury, nickel, paradichlorobenzene and benzo(a)pyrene. The possibility of using information from these studies to validate the MINTAQ model (see below) was discussed. Several Program Office representatives attended to describe their current efforts on the topic of lead. Carl Mazza (OTS, FTS 382-3822) discussed possible reg- ulation of lead under TSCA (e.g., mandatory recycling of batteries, and removal of lead and cadmium from certain products) and Alan Rubin (OWRS, FTS 475- 7311) described OWRS's approach to tracing dispersal pathways and calculating risks associated with lead in sewage sludges. Jeanne Briskin (FTS 382-5456) des- cribed the rationale for ODW's proposed MCL for lead. An important question is whether different chemical species of metals (e.g., lead carbonate or lead sulfide) might have different bioavailabilities when ingested by children eating contaminated soils. The answer to that question obviously has significant implications for cleanups at large Superfund and other sites. Some epidemiological data suggesting different bioavail- abilities (i.e., different blood lead values at sites with similar soil lead concentrations) is being examined by Rob Elias (ECAO, FTS 629-4167). Studies using comparable lead analyses are being evaluated, but it isn't clear yet whether they are also comparable with respect to other parameters (e.g., socioeconomic status) that could account for observed differences in blood lead. Dave Brown (Athens ERL, FTS 250-3310) described the MINTAQ model for calculating the chemical behavior of metals in soils or other chemical medium. If capable of describing the behavior of metals in the gastrointestinal tract, this model might be useful for predicting bioavailability. Recommendations for research into the data gaps and a request for clarification of the Agency's position on metals issues will be delivered to the Risk Assessment Forum. The Forum will review these suggestions and make recommendations about further study by the Forum or other appropriate groups (e.g., ORD). II. Headquarters News from the Risk Assessment Forum by Unda C. Tuxen (FTS 475-6743) Exposure Guidelines - in 1986, during the Science Advisory Board (SAB) review of EPA's proposed Guidelines for Estimating Exposures, the SAB recom- mended that additional guidelines be developed to address general principles for measurement of pollutant concentrations and, in addition, the limitations of such measurements for exposure assessment. As a result, draft exposure measurement guidelines were developed that supplement the 1986 guidelines by outlining principles and criteria relating to selecting data sources, sampling methods, selecting and validating analytical methods, evaluating and describing uncertainty in measurement data, and quality assurance/quality control considerations, among other things. The draft-proposed Guidelines for Exposure-Related Measurements were sent to the Risk Assessment Forum. Risk Assessment Council, and the Science Advisory Board for review and recommendations. All three groups welcomed the guidelines. These proposed guidelines were published in the Federal Register (53 FR 48830-48853) on December 2, 1988. The public comment period ends March 2, 1989. Risk Assessment Guidelines Implementation - This program is scheduled to travel to several regions and laboratories in Winter/Spring 1989. The preliminary schedule is listed on p. 3. BEIR IV Report on Radon Now Available by Frederick Hodge (FTS 475-9650) /Health Risks of Radon and Other Internally Deposited Alpha-Emitters. BEIR IV authored by the Committee on the Biological Effects of Ionizing Radiation, Board on Radiation Effects Research, Commission on Life Sciences. National Research Council, published by the National Academy Press, Washington, DC, 1988.] 2 ------- Risk Assessment Guidelines Implementation - Preliminary Schedule Guidelines Place Date Course(s) Contact Boston March" Exposure Sara Levinson Region 1 Assessment 8-833-1718 - Workshop New York February" Manager's Man an Olsen Region II Seminar 8-264-5682 February * Carcinogen- icity Workshop March * Chemical Mixtures Workshop April" Developmental Toxicity Workshop May* Mutagenicity Workshop May* Exposure Assessment Workshop "* Atlanta January 17 Developmental Elmer Akin Region IV Toxicity 8-257-2643 Workshop March * Carcinogen- icity Workshop April * Mutagenicity Workshop Chicago January 19 Carcinogen- David Dolan Region V icity Workshop 8-886-6195 Kansas City February * Chemical Jaci Region VII Mixtures Schlachter Workshop 8-757-2815 March * Carcinogen- icity Workshop San Francisco Week of Developmental Arnold Den Region IX January 23 Toxicity 8-454-0906 Workshop February Exposure 13-14 Assessment Workshop" Seattle February Exposure Pat Cirone Region X 9-10 Assessment 8-399-1597 Workshop" March * Carcinogen- icity Workshop RTP, N.C. January Exposure Mike Davis ECAO/ 18-19 Assessment 8-629-4162 OAOPS Workshop" January 30 Mutagenicity Fred Workshop Hauchman 8-629-5339 " Tentatively scheduled, subject to availability of resources. To obtain further information on status, call CONTACT listed. * Exposure Assessment Course - Two-day course on exposure assessment, including guidelines. Biological Effects of Ionizing Radiation (BEIR) committees are composed of experts in their field and are appointed and governed by the Board on Radiation Effects Research of the Commission on Life Sciences, National Research Council, National Academy of Sciences. Historically, the EPA has used previous BEIR Reports as the basis of their risk estimates in writing federal standards for the various radiation hazards to the U.S. population. The National Research Council was established by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. The National Academy of Sciences operates under the authorization of the charter granted to it by Congress in 1863, which established it as a private, non-profit, self-perpet- uating society of distinguished scholars dedicated to furthering science and technology. The Academy is not a federal agency nor is it connected to the federal government. It operates strictly through contracts from federal agencies. The present BEIR Report, BEIR IV, was jointly funded by the Environmental Protection Agency and the Nuclear Regulatory Commission. BEIR IV describes hazards from radon progeny and other alpha-emitting radionuclides that humans may inhale or ingest from their environment. Based on a new analysis of epidemiological data collected on four groups of underground miners, original risk estimates for lung cancer from the inhalation of radon decay products are presented. The report also provides risk estimates for radium, thorium, polonium, uranium, and man-made radionuclides such as plutonium and other transuranic elements. However, the largest and most important part of the report deals with health effects of exposure to radon and its progeny, primarily because of a need to characterize the lung cancer risk associated with exposure to radon and its short-lived daughters in indoor domestic environments. To fit the miner data, the committee developed a model in which the risk varies in a complex fashion with age and time since exposure. Based on a review of information on radon dosimetry in the lung, the committee recommended that the model developed from the miner data be applied directly to the case of indoor exposures of the general public. It also recommended that a multiplicative interaction between smoking and radon be assumed. The estimate of lifetime risk due to constant lifetime exposure to radon progeny was estimated to be 350 deaths/106 person-WLM* (excess lifetime lung cancer mortality). This falls within the range of risk estimates which EPA has used in recent guidance and rulemaking (230-920 deaths/106 person-WLM). "Working Level Month (WLM) is a unit of exposure to radon progeny. It is defined as the exposure resulting from the inhalation of air with a concentration of 1 working level of radon daughters lor 170 working hours. A Working Level (WL) is any combination of short-lived radon progeny in 1 liter of air that will result in the ultimate of emission 1 3x10s MeV of alpha energy. To a close approximation. 1 WL is also the alpha energy released from the decay of progeny in equilibrium with 100 picocuries of 222 Ra. 3 ------- The differences between risks in mining and domestic environments ard the interaction between smoking (a major synergistic contributor) and exposure to radon progeny are not fully resolved. The NAS and EPA are in the process of establishing a panel to look at the extrapolation of risk estimates of radon-induced lung cancer in underground aniners to residential radon exposures to the general population. In addition to a rather sophisticated presentation and discussion of radon risk estimates, BEIR IV also summarizes clinical and epidemiological evidence, the results of animal studies, research on alpha-particle damage at the cellular level, metabolic pathways for internal alpha-emitters, dosimetry and microdosimetry of radionuclides deposited in specific tissues, and the chemical toxicity of some low specific activity alpha- emitters. Copies of the 8E1R IV Report are available for $32.50 (paperbouod) and $42.50 (hardbound) from the National Academy Press, 2102 Constitution Ave., NW, Washington, DC, 20418. (II. Around the Regions Fourth Regional Risk Assessment Meeting The fourth Regional Risk Assessment Conference, which is being hosted by Region 10, will be held on May 9-12, 1989, in the Sheraton Hotel in Seattle. A block of rooms is reserved at the hotel for out-of- town participants. Information on the room reservations will be sent to all regions as soon as the agenda is finalized. The exchange of information afforded by these conferences is extremely valuable in enhancing EPA's expertise in risk assessment. In order to assure that EPA regions have input into this information exchange, we are asking that representatives from each region present a talk on risk assessment issues which are relevant to their program. Please send your suggestions for topics to Pat Cirone (FTS 399-1597) by January 30, 1989, so that the agenda can be finalized by February 15. Preliminary Agenda May 9 Regional Human Health Risk Assessment Issues Chairperson: QanaOavoli, Region 10, FTS 39&-2135 1. Panel discussions on: ~ NESHAPS Rule on Benzene - Pesticides - Fish Consumption Risks vs Benefits 2. Guest Speaker: Dose-Response 3. Bioavailability 4. Indoor Air May 10 Headquarters and Genera/ Issues Chairperson: Amoid Den, Region 9, FTS 454-0906 t. Guest Speaker: National Toxicology Program 2. Revisions to Cancer Guidelines 3. Developmental Toxicity Guidelines 4. Male and Female Reproductive Guidelines 5. Systemic Non-Cancer Guidelines 6. Revisions to Qioxin Toxicity Equivalence Factors 7. Inhalation RFDs May 11 Regional Ecological Risk Assessment Issues Chairperson: Elmer Akin, Region 4, FTS 257-2234 Co-Chairperson: Jon Rauscher, Region 6, FTS 255-6710 1. Guest Speaker: Perspective on Ecological Risk Assessment 2. Status Reports and Discussion of Agency-wide ecology topics: - Superfund Environmental Evaluation Manual - Ecological Assessment Manual - Ecotoxicity Subcommittee of Risk Assessment Council - EcoRisk Technical Support Center - Sediment Quality Criteria - Superfund Bio assessment Workgroups 3. Regional Case Studies 4. Open discussion of ecological research needs and other regional items of interest May 12 (1/2 day} Administrative Issues Related to Risk Assessment Chairperson: Bill Muszynski, Region II (Contact Marian Olsen, FTS 264-5682) 1. Overview - Lead Region Activities 2. Risk Assessment Training 3. Peer Review Process and Quality Assurance of Risk Assessments 4. Risk Communication 5. Next Regional Meeting and Wrap up EPA Laboratories are invited to present their programs in the poster sessions which will be held throughout the 3 f 2 days Contact: Pat Cirone (FTS 399-1597) IV. Announcements Seventh Symposium on Methods tor Environmental Quantitative Risk Assessment The U S Environmental Protection Agency and the Center for Environmental Epidemiology of the University of Pittsburgh will sponsor the Seventh Symposium on Methods of Environmental Quantitative Risk Assess- 4 ------- ment on April 3 - 5, 1989. The Symposium will be held at the auditorium of the graduate School of Public Health of the University of Pittsburgh. The symposium will include the following topics: I. Recent Developments in Multistage Models of Carcinogenesis. ~ II. Biologically Motivated Models for Cancer Risk. III. The Role of Biologic Markers in Quantitative Risk Assessment. IV. Methods for Modeling Reproductive and Other Non-Cancer Health Effects. V. Future Directions for Research in Quantitative Risk Assessment. The registration fee for the Symposium is $125 and attendance will be limited. For more information concerning the symposium, please contact the Center for Environmental Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA 15261. The phone number is (412) 624-1559. Carcinogen Risk Assessment Course Offered by Society for Risk Analysis The Society for Risk Analysis will be offering a course on Carcinogen Risk Assessment on April 3 - 5, 1989 at One Washington Circle Hotel in Washington, DC. The course will cover the risk assessment process, the use of scientific data in risk assessment, risk initiatives in federal agencies, and risk management. Special emphasis will be given to new developments in the areas of biologically-based modeling, pharmaco- kinetics and biomarkers. The agenda for the meeting is: Monday, April 3,1989 I. OVERVIEW OF RISK ASSESSMENT Lecture 1 8:30 - 9:45 Risk Analysis: An Introduction Roy Albert, University of Cincinnati Lecture 2 10 :15 - 11.30 The Risk Analysis Process Betty Anderson, ICF/Clement II. THE USE OF SCIENTIFIC DATA IN RISK ASSESSMENT Lecture 3 12:45 - 2:00 Epidemiology Mimi Yu, Univ. Southern California School of Medicine Lecture 4 2:00 - 3:15 Reproductive Risk Mildred Christian, Argus Research Lecture 5 3:45 - 5:00 Neurological Risk of Lead Lester Grant, USEPA Tuesday, April 4,1989 III. RISK INITIATIVES IN EPA Lecture 6 8:30 - 9:45 Risk Analysis at EPA Bill Farland, USEPA IV. SPECIAL ISSUES IN RISK ASSESSMENT Lecture 7 10:15 - 11:30 Exposure Assessment C. C. Travis, Oak Ridge National Laboratory Lecture 8 12:45 - 2:00 Biomarkers, Bernard Goldstein Robert Wood Johnson Medical School Lecture 9 2:00 - 3:15 Promotion as a Factor in Risk Assessment James Trosko, Michigan State University Lecture 10 3:45 - 5:00 Pharmacokinetics and Inter-species Extrapo- lation C. C. Travis, Oak Ridge National Laboratory Wednesday, April 5,1989 Lecture 11 8:30 - 9:45 Acceptable Risk Chris Whipple, EPRI Lecture 12 10:15 - 11:30 Risk Management Lester Lave, Carnegie-Mellon Lecture 13 12:45 - 2:00 Risk Communication Vince Covello, Columbia University The registration fee is $500 for non-government employees and $350 for government employees. The registration fee includes a one-year society membership with journal subscription, a complimentary cooy of the new textbook. Carcinogen Risk Assessment, a wine and cheese reception, and daily morning and afternoon refreshment breaks. Hotel accommodations are available at the One Washington Circle Hotel. One Washington Circle, NW, Washington, DC. A block of rooms are available at a special Society of Risk Analysis rate of $105 per night. For room reservations, please call the hotel at 1-800- 424-9671 or direct dial at (202) 972-1680 by March 16. 1989, and identify yourself as an SRA workshop attendee. 5 ------- For further information please contact Mary Oran, Conference Coordinator, Oak Ridge National Laboratory, P. 0. Box 2008, Bldg. 4500S, MS 6109, Oak Ridge, Tennessee 37831-6109. Mary can be contacted at (615) 574-8438 or FTS 624-8438. PCGEMS Training Workshop The University of Wisconsin, Center for Continuing Engineering Education, will be presenting a 5-day training workshop in Milwaukee from January 30 through February 3, 1989, on the Graphical Exposure Modeling System Micro Computer Version (PC- GEMS). PC-GEMS was developed by the Office of Toxic Substances, USEPA as an interactive information management tool designed to assist in a quick and meaningful analysis of environmental problems. PC- GEMS features work both independently and in concert with the more powerful counterparts on the mainframe. The system provides the following capabilities: Environmental Fate and Transport Modeling for Risk and Decisionmaking Courses Scheduled The following is the schedule for the Risk and Decision Making Courses through April: Region VI Region VII Region IX January 18-19 January 18-19 January 24 - 26 Region V - Region I Region VII - Region III - Region VI - Region IX - Region VII - Region V - Region IV - February 14-15 February 22 - 23 February 22 - 23 March 1 - 2 March 22 - 23 March 20 - 22 March 22 - 23 April 11-12 April 26 - 28 Contact: Mary Setnicar (FTS 382-2747) Contacts: Surface Water, Air, Groundwater and Soil, Jerome Puskin OAR-Rad. FTS 475-9640 Chemical Property Estimation, Linda Tuxen ORD-RAF FTS 475-6743 File Management. Dick Hill OPTS FTS 382-2897 Graphical Display of Modeled Analyses, Don Barnes SAB FTS 382-4126 Mapping, and Dean Hill NEIC FTS 776-8138 Selected GEMS data sites. Marian Olsen Region II FTS 264-5682 PC-GEMS provides a tool for planners, engineers, Roy Smith Region III FTS 597-6682 hydrogeologists and environmental specialists/scientists Elmer Akin Region IV FTS 257-2234 to manage and analyze: Dave Dolan Region V FTS 886-6195 Environmental Fate and Transport, Jill Lyons Region VI FTS 255-7208 Chemical Property Estimation, Bob Fenemore Region VII FTS 757-2970 Data Management, Arnold Den Region IX FTS 454-0906 Graphics, Dana Davoli Region X FTS 399-2135 Geographic Data Analysis and Mapping, and Statistical Analysis. Course speakers are: Russell Kinerson, Chief, Modeling Section Exposure Assessment Branch, U. S. Environmental Protection Agency, Office of Toxic Substances, Scott Rheingrover, General Science Corporation, Laurel, Maryland, Stuart Wollman, General Science Corporation, Laurel, Maryland, and Stephen J. Scott, University of Wisconsin - Milwaukee, Center for Continuing Engineering Education. The registration fee for the course is $995 for the 5- day training workshop and the enrollment is limited to 20 students. Further information concerning the course is available from Dr. Stephen J. Scott - Program Director, Civil/Environmental Engineering, Center for Continuing Engineering Education, College of Engineering and Applied Science, 929 North Sixth Street, Milwaukee, Wisconsin 53203. Dr. Scott can be contacted at (414) 227-3100. If you would like to receive additional copies of this and subsequent Reviews or to be added to the mailing list, contact: CERI Distribution 26 W. Martin Luther King Drive Cincinnati, OH 45268 Need Help? If your office needs help in finding information or assistance on a specific risk assessment problem, you can announce that need on the Risk Assessment/Risk Management Bulletin Board now available on E-Mail. Your colleagues from other offices who have information or advice will be able to contact you with assistance. For assistance in posting announcements or reading entries on the Bulletin Board, contact Electronic Mail User's Support at FTS 382-5629. Your colleagues from other offices who have information or advice will be able to contact you with assistance. 6 ------- |