UNITED STATES ENVIROhMENTAL PROTECTION AGENCY Region II, New York, New York 10278 DATE SUBJECT FRCM March 22, 1988 Risk Assessment Review JZ ¦ rm i aim/J . y n s k i Deputy Regiona1 Administrator 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 twork. 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 Committee members listed on page 1 of the review. At t achmen t ------- February 1988 Highlights o More on EPA's New Risk Communication Program p. 1 o News from the Risk Assessment Council and Forum p. 3 o New Approach for the Establishment of Fish Consumption Advisories p. 7 ® Volatilization of PCB's From Soil p. 8 « Quartz Hill Ecological Risk Assessment ... p. 8 • Next Meeting of Regional Risk Assessors . p. 10 I. Special Feature: MORE ON EPA'S NEW RISK COMMUNICATION PROGRAM Risk communication can help in achieving EPA's mission to reduce environmental risk. This is in part because people tend to worry about some risks that are relatively small, while at the same time not worrying about other risks that are much larger. It takes an effort in terms of time and resources to reduce both large and small risks. Risk communication can help people put various risks in perspective, so that they can understand the trade-offs that must be made in reducing any particular cause of risk. Some of these trade-offs include actions individuals can choose to manage their own risks. Other trade-offs involve regulatory action. Because the public ultimately drives the EPA's regulatory agenda, improved understanding of relative risks is likely to result in pressure for the Agency to address the largest environmental risks. The increased need for careful attention to risk communication as part of EPA's risk management strategies has led to many new risk communication activities across the Agency. The Office of Policy, Planning and Evaluation (OPPE) is managing a Risk Communication Program to assure coordination among the diverse risk communication efforts across the programs and regions, so that we can learn as much as possible about how to make these efforts more effective. Substantive input from the programs and regions is essential to making the Risk Communication Program serve its purpose well. Sometimes this input can be as simple as sharing workplans and reports on studies. Other times the input includes contributing dollar and staff resources to a study initiated by OPPE but designed to assist a program or region. The last two issues of the Risk Assessment Review described why risk communication is so important and gave details about two of the four functions under the Risk Communication Program. (These two functions were facilitating and evaluating the effectiveness of actual risk communication activities and developing improved methods for communicating risks.) This issue covers the outreach and clearinghouse function, and the next one will cover risk communication training. CLEARINGHOUSE The most important part of the outreach and clearinghouse function for EPA staff is the Risk Assessment Review Committee Peter Preuss - ORD, FTS 382-7669 Sally Edwards - Region I, (617) 565-2993 Maria Pavlova - OTS, FTS 382-3801 Marian Olsen - Region II, FTS 264-5682 Susan Deihl - Region IV, FTS 257-5065 Suzanne Wuerthele - Region VIII, FTS 564-1743 Dana Davoli - Region X, FTS 399-2135 clearinghouse component. One example of this is the annotated list of risk communication and risk training projects that is maintained on the E-Mail Risk Assessment/Risk Management Bulletin Board. Anyone who missed the last two issues of the Risk Assessment Review or wants an immediate preview about risk training can consult this list. (Once in E-Mail, type "PRPOST" at the > prompt, and "RISK" when asked for a category. Occasionally the list is removed for updating.) Clearinghouse activities also include a risk communication hotline. The number is FTS 382-5606. The person answering the hotline will respond directly to questions or refer the caller to whoever on EPA's staff can provide the needed expertise in risk communication. Sometimes the hotline provides information about external experts at universities or consulting firms. The main purpose of the hotline is to provide assistance to EPA program offices and regions. However, we also try to answer questions raised by those in state and local government, universities, and private organizations that are working on risk communication problems. The Risk Communication Program maintains a library as part of its clearinghouse component. The library includes both professional and popular press articles about various risk communication activities at EPA and elsewhere, with an emphasis on the evaluation of how well the risk communication efforts achieved their objectives. The library includes unpublished reports on risk communication studies and descriptions of studies that are underway. It also maintains a file on conferences and workshops related to risk communication. OUTREACH The issues raised in the first paragraph indicate that a greater level of understanding of risk issues is needed if we are going to have informed public input and individual decisions for risk management. Several activities have been initiated that will contribute to this understanding. These include a series of "invitation only" conferences for key opinion leaders from government, industry, public interest groups, and the media, focusing on specially written case studies; a major conference on risk communication in January 1986; partial support and participation in a series of workshops with the media on reporting of risk issues; partial sponsorship of the new Center for Risk Management at Resources for the Future; and 1 ------- preparation and dissemination of papers, articles, and reports on risk communication. EPA also has worked with other agencies through the Task Force on Environmental Cancer and Heart and Lung Disease to conduct a conference on the role of government in communicating about health and environmental risks (January 1987) and one on evaluating risk communication efforts (June 1988). It has been suggested that EPA should reach out to civic and professional groups and the educational establishment as a way to raise the general awareness level and understanding of risk issues. Because this will potentially absorb many resources, we are working through the 14-agency Interagency Task Force on Environmental Cancer and Heart and Lung Disease on a small project to outline what the federal government is doing and might do in this area. The project list below briefly describes clearinghouse and outreach activities that are complete, ongoing, or proposed. A contact name and phone number are included, so that you can find out more about a specific study. For more information on the Risk Communication Program in general, call its hotline number, FTS 382- 5606. PROJECT LIST: CLEARINGHOUSE, OUTREACH AND GENERAL PUBLIC EDUCATION Ongoing/ Completed 1. Hotline for Regions and Program Offices: To serve as an up-to-date resource for information on risk communication research, skill building, implementation, and evaluation: FTS 382-5606 (in place 4/87) 2. Risk Assessment Review includes articles about Agency activities in risk assessment, risk management, and risk communication. (Peter Preuss, FTS 382-7315 or William Muszynski, FTS 264-0396) 3. E-mail updates of Agency's risk communication activities. (Elaine Danyluk, FTS 382-5606) 4. "Tidewater" conferences for key public opinion leaders from government, industry, public interest groups, media, etc, focusing on case studies ("Dinitrochickenwire") on risk assessment and risk management. (Pam Stirling, FTS 382-2747) 5. National Conference on Risk Communication, Washington, D.C., January 1986: proceedings published, Fall 1987. (Derry Allen, FTS 382-4012) 6. Seminars for the press on risk communication (with Georgetown University and other universities). Six held so far, with more planned. (OPPE and Public Affairs). (Derry Allen, FTS 382-4012) 7. Integrated Environmental Management Program (OPPE): various special risk assessment/ management/communication efforts at Philadelphia. Baltimore, Santa Clara. Denver, Kanawha Valley, Regions I. Ill, X, and the Commonwealth of Pennsylvania (ongoing). (Dan Beardsley, FTS 382- 2747) 8. Comparative Risk Project: report widely circulated, publicized and discussed; follow-up conference planned for April 1988. (Derry Allen, FTS 382- 4012) 9. Article comparing results from Comparative Risk Project with rankings of environmental problems by the public, examining reasons for and implications of differences; accepted for publication in Risk Analysis. (Derry Allen, FTS 382-4012). 10. Article on New York State radon risk communication study for Science, Technology and Human Values. (Ann Fisher, FTS 382-5500) 11. Center for Risk Management (at Resources for the Future). EPA's agency-wide contribution is providing approximately one-third of the funding (with the rest coming from foundations and industry). Functions include research, analysis, education and outreach on risk management and risk communication. Initiated April 1987. (Ann Fisher, FTS 382-5500) 12. Interagency workshops on risk communication, sponsored by the Task Force on Environmental Cancer and Heart and Lung Disease (composed of 14 federal agencies and chaired by EPA). The first workshop was held in January 1987. The second will focus on evaluating risk communication and is planned for June 1988. (Derry Allen, FTS 382- 4012, Ann Fisher, FTS 382-5500, Maria Pavlova, FTS 382-3580) 13. National Conference on Environmental Gridlock, Princeton, NJ, November 1987. Report being drafted. (Margaret Randol, FTS 264-4535). 14. National Institute of Chemical Studies: OPPE helped plan and participated in a risk communication conference in Charleston, WV, March 1987. (Derry Allen, FTS 382-4012) 15. Texas Risk Communication Project: Multiple sponsors included Texas Chemical Council and EPA's Region VI. A two-day workshop was held October 16-17, 1987, focusing on a communications package that can be used for presenting chemical risks to diverse audiences. (Ellen Greenay or Tim Underwood, FTS 255-6735) 16. EPA speakers and panels on risk communication at various conferences, including Society for Risk Analysis (11/86, 11/87), Public Relations Society of America (11/86), APCA (10/87, 6/88), Hazardous Materials Spills Conference, Environmetrics 87, etc (OPPE, ODW, OSWER). Contact: Ann Fisher, FTS 382-5500 2 ------- II. From Headquarters NEWS FROM THE RISK ASSESSMENT COUNCIL By Don Barnes (FTS 382-4126) 1. Risk assessment for the ingestion of inorganic arsenic -- or "Just how bad is arsenic, anyway?" "Ask Napoleon!" In 1987 the Risk Assessment Forum produced a report on the hazard identification and dose-response assessment of ingested inorganic arsenic. This update of a 1984 Agency assessment confirmed the association between the ingestion of the chemical and the risk of skin cancer. Based upon a reanalysis of the exposure information of the human studies that were the basis of the assessment, the report presented a potency which was about 10-fold lower than the 1984 estimate. The Risk Assessment Council adopted the report. In addition the Council addressed the science policy issue of how the Agency should view the skin cancer response vis a vis its view of other cancer (e.g., internal organ) responses. After examining a series of considerations (e.g., skin cancers are generally easily detected, simply treated, and rarely fatal), the Council recommended that, as a matter of science policy, the Agency modify the potency estimate downward by an additional 10-fold factor. The Council forwarded the Forum report, which now includes the Council recommendation, to the Science Advisory Board (SAB), asking for a review of the science policy recommendation. The Executive Committee of the SAB expressed some unease in addressing the policy issue but referred the matter to the SAB's Environmental Health Committee for their views on whether the SAB should accept the request to review the policy recommendation. The Environmental Health Committee discussed the issue at their meeting in late January and is preparing a response to the Executive Committee at this time. A number of Regions have situations in which inorganic arsenic plays a significant role. Therefore, they are following developments with interest. 2. Examining Assumptions in Risk Subcommittee (EARS) -- or "He who has ears, let him hear!" The Risk Assessment Council has established a subcommittee to take a close look at some of the assumptions which are inherent in the way the risks are generally assessed. Lists of such assumptions have been generated in the last few years by groups both inside and outside the Agency. The goal of the subcommittee, chaired by Ken Sexton, Director of the Office of Health Research in the Office of Research and Development, is to identify those assumptions (both in the toxicity and exposure areas) which have the greatest impact on the estimates of risk. These assumptions will be examined in some detail, considering alternatives and the possibfe compounding of conservativeness which results. The subcommittee will report back to the Council at its meeting in May. In addition to their near-term results, their efforts should also provide useful guidance for the preparation of longer-term research activities. NEWS FROM THE RISK ASSESSMENT FORUM By Linda C. Tuxen (FTS 475-6743) NEW FORUM MEMBERS - The Risk Assessment Council has appointed several new members from Regional Offices, EPA Laboratories, and Headquarters to the 1988 Risk Assessment Forum. The Forum is pleased that membership is more representative of offices beyond Headquarters and enthusiastically welcomes all its new members. The new Forum members are: lla Cote (OAQPS/RTP), Lee Mulkey (Athens Lab), Roy Smith (Region III), Mike Callahan (EAD/OHEA/Hq), and Elizabeth Bryan (ERD/OTS/Hq). In 1987, the Risk Assessment Council recommended that the Forum's membership be enlarged from 10 to 13 to allow more exposure expertise. This was approved by the Administrator and the Forum's Charter was amended to reflect this change. Consistent with this, three of the new members are experts in the field of exposure analysis and assessments. REPRODUCTIVE EFFECTS GUIDELINES - Proposals for two new risk assessment guidelines will soon be published in the FEDERAL REGISTER for public comment. "Proposed Guidelines for Assessing Female Reproductive Risk" and "Proposed Guidelines for Assessing Male Reproductive Risk," were developed by interoffice work groups that report to the Risk Assessment Forum. Following Risk Assessment Council review, the proposals have been forwarded tp the Administrator and to Science Advisory Board for review. These proposed guidelines describe the procedures that EPA would follow in evaluating potential toxicity to the human female and male reproductive systems. ARSENIC - A notice of availability of the Risk Assessment Forum's report on ingested inorganic arsenic was published in the FEDERAL REGISTER on January 22, 1988 (53 FR 1835). The notice announces that EPA has asked the Science Advisory Board to review the Risk Assessment Council's policy statement that recommends modification of the Forum's skin cancer risk estimate and sets a March 15, 1988 deadline for any public comments. To obtain a single copy of the Forum document (Document Number EPA-625/3-87/013A) contact: ORD Publications Office, CERI-FRN, U.S. Environmental Protection Agency, 26 Martin Luther King Drive, Cincinnati, Ohio 45268, Telephone: (513) 569- 7562 (FTS 684-7562). The document will be distributed from the Cincinnati office only. RISK ASSESSMENT FORUM COLLOQUIA - The Risk Assessment Forum has scheduled several colloquia on risk assessment issues of Agency-wide interest. These discussions are undertaken to identify issues for later in-depth study by the Forum or some other Agency group, and to obtain input across Agency programs on 3 ------- the issue. Recent colloquia are described below, along with information about future events. • Showering Risk Colloquium - On January 12, 1988 the Forum sponsored an all-day colloquium on the evaluation of risks from showering with water contaminated with volatile organic chemicals (VOCs). The objective of the colloquium was to determine whether the Forum should study risks from showering and other uses of VOC-contaminated water. The meeting was chaired by Suzanne Wuerthele of Region VIII, and was attended by scientists from Headquarters, Regional offices and other Agencies. The colloquium chair and attending Forum members will develop recommendations regarding future study of the topic by the Forum or some other Agency group. • RfD Apportionment Colloquium - On January 26, 1988 the Risk Assessment Forum sponsored a half- day colloquium on the issue of reference dose (RfD) apportionment. The meeting was well attended, with representatives from many EPA program offices. Colloquium participants focused on issues relating to apportioning the RfD among media and matrices and to identifying decision criteria on apportionment to meet the regulatory needs of different EPA offices. These issues are of interest because the Agency studies exposure from all sources to avoid exposure in excess of the RfD. RfD apportionment involves reserving a portion of the total RfD that will then be fractionated among different media where exposure may result. Forum members attending the colloquium will develop a "sense of the meeting" statement and make recommendations to the Forum. • Colloquia scheduled for February and March are listed below. TOPIC DATES/TIME/PLACE Quantitative Low Dose February 26, 1988, 9:00-4:30 p.m. Extrapolation - New Methods Headquarters, Room 1, North WIC Soil Exposure Assessment March 23,1988, 9:00-4:30 p.m. Headquarters, Room 1, North WIC THYROID NEOPLASIA - A Risk Assessment Forum Technical Panel draft report entitled "Thyroid Follicular Cell Carcinogenesis: Mechanistic and Science Policy Considerations" proposes a new approach to EPA analysis of carcinogenic agents that induce thyroid neoplasia Specifically, the report proposes that carcinogenesis in thyroid follicular cells be analyzed as a threshold phenomenon, and that end points other than neoplasia can be used for cancer risk for chemicals that induce thyroid follicular cell neoplasia. The draft report has been forwarded by the Risk Assessment Council Chairman to the Agency's Science Advisory Board (SAB) for revitew. The Council also recommended that an appropriate chemical be identified to use as a case study of the principles and procedures set forth in the report. Dr. Richard Hill of OTS chaired this project. The scientific analysis and policy recommendations in this report are based in the main on laboratory studies in which thyroid tumors in animals exposed to chemical substances were linked to disruption of the normal function of the thyroid and pituitary glands. These findings were largely described in a 1986 Office of Pesticide Programs report, which was favorably reviewed by the FIFRA Scientific Advisory Panel (SAP) and independent outside reviewers. The Forum analysis enlarges upon some of the issues developed in the OPP paper and provides analyses of additional topics. The science policy proposal for chemicals that induce thyroid follicular cell neoplasia builds upon guidance in the EPA cancer guidelines. The guidelines call for use of mechanistic and other relevant information in making choices about the models to be used in extrapolating from high to low exposures. The thyroid neoplasia report proposes that under clearly specified conditions, human risk for thyroid follicular cell neoplasia should be evaluated in accordance with risk assessment principles for analyzing "threshold" phenomena, as is done with reproductive or neurologic effects. This method is proposed in lieu of linear extrapolation methods which generally have been employed by the Agency in assessing carcinogenic substances. In the case of the thyroid gland, EPA scientists would use metabolic, toxicological, and other ancillary data on preneoplastic endpoints to identify NOAELs and LOAELs as estimates of potency, rather than using data on tumor incidence as is customary for carcinogenic compounds. A notice of availability of the draft document and a date for the SAB meeting on this topic will be published in future FEDERAL REGISTER notices. EMERGENCY PLANNING AND COMMUNITY RIGHT-TO-KNOW NEEDS ASSESSMENT AND EDUCATIONAL RESOURCE DEVELOPMENT By Maria Pavlova (FTS 382-3801) The provisions of Title III of SARA require programs to prepare Federal, State and local decision-makers, citizens' groups, and individuals to understand emerging information about the presence of toxic substances and to use this information as a basis for action where necessary. The Office of Toxic Substances (OTS) is developing a public education and communication program to improve understanding of toxic substances, to provide a context for interpreting the potential impact of new information on a community, and to allow for more informed public participation on toxic substance related issues. The needs assessment project will provide information regarding the current state of public knowledge and opinion, credible messages, and delivery channels needed to develop educational programs. The goals of the project are: 4 ------- • To identify state and public awareness and understanding of the presence of toxic substances in communities, • To identify public needs and wants for information related to toxic substances and associated risks, and • To provide educational materials and a context for understanding toxic chemicals and their potential effects targeted to different audiences within local communities. The program will include the following activities: 1. Assessing public needs and identifying channels and intermediaries for message delivery, 2. Identifying and evaluating existing educational materials, 3. Developing messages and new or modified educational materials, 4. Pretesting educational materials and identifying dissemination channels, and 5. Developing and recommending how to organize communication programs on toxic substances including design and evaluation. The needs assessment will be designed to reveal how specific segments of the public, opinion leaders, and potential intermediaries (i.e., citizens in affected communities, environmentalists, teachers, health professionals, local officials, and members of interested organizations) think about issues related to environmental risks, and specifically about the presence of toxic substances in their communities. Areas of inquiry will include: • Knowledge and awareness of the existence and risks of toxic substances, • Misconceptions, unwarranted anxiety, apathy and other obstacles to the productive application of information about toxic substances, • Concerns, interests and desires for information, • Sources of information perceived as credible by specific segments of the public, • Interest in community involvement and potential participation concerning toxic substances, and • Characteristics of specific target audiences which influence communication (i.e., attitudes, knowledge, demography, interest, and relationship to the problem). A series of focus groups will be convened to assess knowledge levels and information needs about risks from toxic substances. The results from the focus groups will be used to get feedback about tools and techniques EPA is preparing for the toxic release inventory users and to develop informational materials. An inventory of Public Education Materials related to toxic substances and associated risks is being prepared. These educational materials will be used to explain the meaning and implications of toxic substances and to enhance public understanding in local communities of terms such as emission, risk, toxicity, dose, exposure and health effects. We want to include any materials that you have produced, used or recommended to the public. A copy of the Inventory will be available in early Spring of 1988. TITLE III RISK SCREENING GUIDE By David Klauder (FTS 382-3628) As one component of the Emergency Planning and Community Right-to-Know Act (Title III) of 1986, the Office of Toxic Substances (OTS) is managing the development of a Risk Screening Guide designed to assist Regional, state, and local health and environmental officials to respond to risk-related questions concerning routine releases of certain toxic chemicals. Under Section 313 of Title III, certain industries are required to report to EPA and the states annual releases into air, water, and land, including publicly owned treatment works, landfills, and off-site disposal of each chemical on a list of toxic chemicals. For calendar year 1987 these emission estimates are to be submitted on or before July 1, 1988. EPA is required to establish a national data base to make these emissions data available to the public. OTS has undertaken a program to assist Federal, state, and local decision-makers, citizens' groups, and individuals in identifying and using appropriate tools for interpreting Section 313 emissions data. One component of this program is a project to develop a Risk Screening Guide to assist first-line responders in answering questions regarding toxicity, exposure, and risk. Two steering committees have been set up to provide guidance to this project: an external committee with representation from EPA Regional, state and local governments and public interest groups, and an internal cross-program EPA committee. The primary responsibility of the external steering committee, the Section 313 Risk Screening Workgroup, is to generate sample risk-related questions which could reasonably be expected to be asked by concerned citizens when the emissions data are publicly available and to describe the technical needs for responding to these questions. The internal steering committee, the Section 313 Expression of Risk Workgroup, will provide guidance on matching available risk screening tools with the expressed technical needs. After three meetings of the internal and one of the external steering committees, an outline of the Risk Screening Guide is under development. The body of the Guide is expected to be in question-and-answer format. The responses to many of the questions will point the user to additional information available for a more in-depth response, e.g., (1) qualitative and possibly semi-quantitative risk screening methods 5 ------- suitable for use on the Section 313 emissions data in order to identify follow-up information-gathering priorities, (2) chemical hazard profiles, (3) existing federal and state chemical standards, (4) additional sources of data on environmental releases or ambient concentrations of Section 313 chemicals which might be linked to facility releases, (5) information on likely release patterns (duration, frequency, etc.) by industry type, and (6) a description of available quantitative risk assessment models including their data input requirements, appropriate for more detailed risk analyses and control option decision-making purposes. A draft Risk Screening Guide is expected to be completed in time to be presented at the five Title III data management and evaluation workshops for Regional, state, and local officials to be held in the Regions during May and June. Revisions in the draft Guide will be undertaken based upon the comments and recommendations offered by participants at these training workshops and from other "tool evaluation" projects currently under development. REVISED VERSION OF IRIS ON-LINE By Jacqueline Patterson (FTS 684-7574) The Integrated Risk Information System (IRIS), EPA's primary data base of risk assessment information, has been revised. IRIS is available to EPA personnel and state agencies on EPA's Electronic Mail (E-Mail) system. This spring IRIS should be available to those outside of EPA. IRIS contains summary risk assessment information on over 260 chemicals. The previous format of IRIS has been revised to assure greater consistency among sections and to reduce the amount of time needed to scroll through or download a file. The appearance of the chemical files has changed, but the types of information remain the same. The regulatory action sections have been expanded and 24 drinking water health advisories have been added. In addition, the background documents have been edited. When accessing IRIS, the user can determine the latest changes by reading the opening banner message and typing INFO MORE at the "Enter a Service code" prompt. Users should refer to Service Code 2 to find out which chemicals have been added or revised, and Service Code 3 for details about specific revisions to the chemical file. Comments and questions on IRIS are welcome; contact IRIS User Support, FTS 684-7254 or Jacqueline Patterson, ECAO-Cincinnati, FTS 684-7574. Paper copies of the background documents describing the Reference Dose and Carcinogen Assessment review process may also be obtained from IRIS User Support. ACCESS TO STARA DATA BASE NOW AVAILABLE By Jacqueline Patterson (FTS 684-7574) The STARA (Studies on Toxicity Applicable to Risk Assessment) data base is now available on the NCC/IBM mainframe using TSO. STARA contains quantitative and qualitative toxicity data at the dose group level. The data are from world-wide literature searches of scientific publications but include only those studies containing quantitative data useful for health risk assessment. Toxicity Files for 160 chemicals and Epidemiology Files for 30 chemicals are available. The Toxicity Files contain detailed data from laboratory animal studies and brief summaries of human clinical and epidemiologic studies. The Epidemiology Files contain detailed data from epidemiology studies including study population characteristics, exposure measures, statistical results, and descriptions of observed effects. This data base will be periodically updated and revised. For more information or a Users Guide, contact Richard Hertzberg, ECAO-Cincinnati, FTS 684-7582. III. Around The Regions Region III WEST VIRGINIA REGULATIONS BASED ON RISK- BASED SCREENING STUDY The West Virginia Air Pollution Control Commission has recently begun development of statewide regulations based on the results of a unique risk-based screening study of the Kanawha Valley, WV. This study, finished in 1987, resulted from a collaboration among Region III, EPA Headquarters (OPPE, OAR, and ORD), and the State. The Kanawha Valley was selected for study because its chemical-industrial complex ranks in size among the top five in the country. Residents and officials in the Valley have long been concerned about potential health impacts of the more than 500 organic chemicals routinely emitted in the Valley, only a few of which are controlled under the Federal Clean Air Act. EPA and WV jointly initiated the toxics screening study in 1985, to estimate the general nature and magnitude of health risks associated with long-term chemical exposures. The study evaluated potential exposures by four routes, with the primary focus on air exposure. The State's new regulations will control, through Best Available Technology (BAT), air emissions of several chemicals which the study suggested pose long-term risks to the public. The regulatory controls will complement those achieved by the Commission through voluntary reductions. Selection of chemicals (all class A and B carcinogens) and control levels will be based on the study's risk estimates. The resulting 6 ------- control priorities should be more accurate and equitable than those based on gross emissions alone. We are hopeful that the success of this effort may convince other state and local agencies to manage risks based on similar geographic analyses. Contact: Thomas A. Slenkamp (FTS 597-9861) Region IV RISK ASSESSMENT AND DECISION-MAKING TRAINING Region IV scheduled its second FY-88 presentation of the workshop "Risk Assessment and Decision Making" for March 1-2 in Atlanta. This was our first presentation with an all Region IV facilitator staff. We anticipated an attendance of about 34 persons, half from the states and half representing EPA project or unit managers. Facilitator training was also provided for appropriate state employees and all members of the Region's Risk Advisory Committee. Future plans call for this basic risk course to be given each quarter until all appropriate EPA employees have been reached. Also, some states have requested our assistance to their facilitators in providing the course at state locations. Contact: Elmer W. Akin (FTS 257-2234) Region V A NEW APPROACH FOR THE ESTABLISHMENT OF FISH CONSUMPTION ADVISORIES Many current fish consumption advisories are based upon the Food and Drug Administration's chemical contaminant action levels, which were not always developed using modern risk assessment techniques. Moreover, these action levels were not intended to apply to sport fisheries. A new method has been developed that provides a more rigorous scientific basis for developing fish consumption advisories for the Great Lakes region. Unlike previous approaches used by regulatory agencies, the proposed approach incorporates the dissemination of comparative risk information to the public and thus permits fully informed decisions regarding the consumption of fish. The method translates the total calculated carcinogenic risk of chemical residues found in a particular fish species over various size ranges into point values for a single meal of fish. Therefore, a meal of fish is worth a specified number of points. The method is very similar to counting calories. The fish consumer selects a desired excess lifetime cancer risk that corresponds to a given number of total points of fish meals per year. The approach permits individuals to keep track of their fish consumption and potential risks and readily identify fish having reduced human health risks. This new advisory approach could also be extended to the regulation of commercial fisheries and could prevent the intermittent closing and reopening of some commercial fisheries. Reprints of this report, published in the September issue, Journal of Great Lakes Research, are available upon request. Contact: Milt Clark (FTS 886-3388) Region VI REGION VI PUBLIC WATER SUPPLY ENFORCEMENT PRIORITIES Region VI had the task of initiating enforcement actions against violators of chemical and radiological maximum contaminant levels (MCLs) in drinking water. Because we lacked resources to enforce against all 612 MCL violators, the first step was to prioritize the violations. To do this, we applied EPA risk assessment concepts. In the initial phase, the dose-response data presented a problem in that for carcinogens, at any concentration, a risk exists, whereas for non-carcinogens at concentrations below the threshold, there is no risk. At contaminant concentrations above the threshold, a risk exists for the sensitive portion of the population, but the distribution of the risk with concentration is not known. Since we were unable to reconcile the risks of carcinogens versus non-carcinogens, each group was treated independently. Because carcinogens are a health risk at any concentration, they were given a "level one" health effects priority. The non- carcinogens, with four exceptions, were given a "level two" health effects priority. One exception was to elevate nitrate to "level one" because the uncertainty factor is virtually one and because the effects can be manifested in a matter of days. Another exception was to place lead in "level one" because of the high priority it has been given by the Agency. The two remaining exceptions are selenium and fluoride which were given a "level three" health effects priority. Selenium was given this priority because of the uncertainty implicit in the proposal to raise the MCL from 0.010 milligrams per liter to 0.045 milligrams per liter and because the final Health Advisory has not been issued by the Office of Drinking Water. Fluoride was given a "level three" health effects priority because the MCL is based on two case histories involving water systems, populations, and water intake rates that are atypical in this Region. These three priority levels were used to characterize the contaminants by health effects only. To ultimately determine the enforcement priorities, additional factors were considered. These were: exposed population, risk factors for carcinogens, the extent to which the contaminant concentrations exceed the MCL for non- carcinogens, the complexity of treatment facilities, maintenance and operation, and other factors, including the ability of the customers to finance the required improvements. The result of melding these factors together was a priority list that generally includes the "level 1" priority contaminants at the top of the list, and the "level three" priorities at the bottom. Several fluoride violations were, 7 ------- however, included in the upper quartile and one nitrate violation in the lower quartile. The state agencies in Region VI reviewed the procedure and suggested some changes. The Region is currently using the list in selecting the drinking water system having the chemical and radiological MCL violations against which enforcement actions are initiated. Contact: Dr. Edgar Jeffrey (FTS 255-7155) Region IX ASBESTOS RISK Region IX assembled a panel of asbestos experts and an audience of well informed participants to assist the Region in addressing asbestos risk issues that have been raised related to several Superfund asbestos sites in Region IX. Three major topics were discussed at the all day workshop held on February 2, 1988: definition of asbestos (counting and analytical techniques), definition of background and risk characterization. The following recommendations were agreed to at the workshop: 1) Risk assessment, should be done based on the mass of respirable (3 micron diameter cutoff) fibers present. 2) Mass calculation should be done by summing the mass (fiber length and width) for all fibers, not by calculating an average volume. 3) Samples should be analyzed by both direct and indirect preparation methods, making sure the same filter type is used. 4) Background should be determined on a site-by- site basis. Contact: Arnold Den (FTS 454-0906) VOLATILIZATION OF PCBs FROM SOIL The inhalation pathway from contaminated soil should not be overlooked in a risk assessment, even for chemicals considered not to be very volatile. Recently, Region IX used an EPA model for assessing emissions from PCB-contaminated soil (Development of Advisory Levels for PCB Cleanup, ORD, May 1986.) This model predicts the maximum individual risk for exposure to volatilized PCB compounds as a function of soil contamination level. Region IX used the model to predict the potential risk from soil contaminated with an average of 200 ppm of PCBs. The predicted inhalation risk was in the range of 10E-4 to 10E-3. Later when preliminary air monitoring was conducted to verify the model prediction, the inhalation risk was found to be in the range of 10E-5 to 10E-4. Thus the model predicted actual risks within an order of magnitude. Contact: Rick Crume (FTS 454-7109) Region X OLD ARSENIC LACES WELLS In the spring of 1987, a case of peripheral neuropathy in Washington alerted the state health department to arsenic contamination in some of the drinking water wells in central Snohomish County. This patient had high levels of arsenic in his urine and his well water contained 25 parts per million (ppm) of arsenic (500 times EPA's Drinking Water Standard). Since the spring, 7 other individuals in this area who have elevated urinary arsenic have been diagnosed as having symptoms consistent with peripheral neuropathies. Tests of over 700 wells in the area have found that about 4% of the wells (34 wells) have arsenic levels above the drinking water standard and 11 wells have levels above 1.0 ppm. A widespread source of this arsenic contamination of wells is suspected to be mineralization of natural deposits which produced arsenic-bearing ores in the area. However, some clusters of highly contaminated wells may also be affected by increased mobilization of arsenic as a result of mining activities. People with contaminated wells are now using bottled water and state and local officials are discussing the feasibility of constructing a public water supply. However, the cost of such a system may be prohibitive in an area as remote as this one. The state health department has alerted the local health agencies in Washington that wells in other parts of the state with similar geology may be contaminated with arsenic. Because previous studies (in Oregon) and results from Snohomish County suggest that arsenic levels in drinking water wells may vary seasonally as the water table varies, a subset of wells will be sampled monthly for a year. This should provide information as to whether one time sampling of a well is sufficient to indicate violations of the drinking water standard. More extensive sampling of wells in suspect geologic areas in the state may then be done. Contact: Dana Davoli (FTS 399-2135) QUARTZ HILL ECOLOGICAL RISK ASSESSMENT EPA Region X completed an ecological risk assessment for a proposed mining project at Quartz Hill in Alaska. The purpose of this risk assessment was to compare the two proposed alternatives for disposal of tailings generated during the mining operation and to characterize the uncertainty about the data and possible impacts. Decision analysis was used as a framework for describing this risk assessment because it allows for quantitative and qualitative estimates of risk. This process incorporates data or information from three levels: 1) experimental results from the project, 2) experimental results from other projects with similar characteristics, and 3) professional judgment based upon experience and knowledge of physical, chemical and biological phenomena. If the individual decisions 8 ------- are carefully displayed, the final product is better understood. The risk assessment was divided into five steps: 1) description of the ecosystem and the potential hazard, 2) selection of the sensitive populations (targets) and factors which may cause harm (agents), 3) effects assessment (concentration/response) estimates, 4) exposure assessment (spatial and temporal interaction of targets and agents), and 5) risk characterization (uncertainty analysis). The tailings disposal alternatives being evaluated are two bays (Smeaton Bay and Boca de Quadra) with similar biological communities but different physical and chemical characteristics. The agent of concern is copper. The targets include all aquatic organisms observed in either bay. The effects assessment was limited to a comparison to the EPA water quality criterion for copper due to lack of site-specific toxicity data. The probability of a response was therefore predicted as 1.00 if the copper concentration in the bay exceeded the water quality criterion (2.9 micrograms per liter) and 0.00 if it was less than the water quality criterion. The probability of exceeding the water quality criterion for copper is greater in the upper water column (above 100 meters) of Smeaton Bay than in the upper water column (above 100 meters) of Boca de Quadra. Since some of the most commercially valuable species (herring, salmon) are only found in the upper water column, the impacts are expected to be highest for Smeaton Bay fish populations than for Boca de Quadra fish populations. The uncertainty in these probability estimates is very high due to the limited measurements of the copper concentration and the limited measurements of abundances of aquatic organisms. Since this was only a statement of the likelihood of harm due to exposure to copper, it must not be treated as an absolute measure of impact. However, the uncertainty analysis showed that there is greater probability of impact in Smeaton Bay. Contact: Pat Storm (FTS 399-1597) IV. Announcements INTERNATIONAL SYMPOSIUM ON CHEMICAL MIXTURES: RISK ASSESSMENT AND MANAGEMENT An International Symposium on "Chemical Mixtures: Risk Assessment and Management" will be held on June 7 to 9, 1988 at the Omni Netherland Plaza Hotel in downtown Cincinnati, Ohio. The Symposium is being sponsored by the U. S. Environmental Protection Agency in cooperation with the American College of Toxicology, Mobil Oil Corporation, the Society for Risk Analysis, and the University of Cincinnati. Recently, the U. S. Environmental Protection Agency adopted guidelines for Health Risk Assessment of Chemical Mixtures. Assessment of risk from exposure to environmental pollutants typically has been conducted based on the co-individual constituents of the mixture (on a chemical-by-chemical basis). The need to evaluate potential effects of chemical mixtures on human health extends across all media. The goal of this symposium is to review the state-of-the-art techniques and approaches to quantifying the potential risks of exposure to chemical mixtures. This timely symposium is also being held to recognize the intense interest and pioneering efforts in this area of the late Jerry F. Stara, D.V.M., Ph.D. This memorial in his honor acknowledges the many scientific contributions made by Dr. Stara in the field of health risk assessment. Potential session titles include: • Emerging Methodologies • Specific Examples of Chemical Mixtures - Volatiles - Metals • Risk Assessment • Panel Discussions For further information or to register for the symposium, contact Kate Schalk or Cindi Altieri, Eastern Research Group, Inc., 6 Whittemore Street, Arlington, Massachusetts 02174, (617) 648-7809 or 7810 or 7800. There is no registration fee to attend the symposium. CONFERENCE ON TOXIC WASTES AND PUBLIC HEALTH: THE IMPACT OF SUPERFUND The Society for Occupational and Environmental Health (SOEH) is presenting the 1988 Annual Conference on Toxic Wastes and Public Health: the Impact of Superfund on April 25 to 27, 1988 at the Dupont Plaza Hotel in Washington, D. C. The conference will be co- sponsored by the Agency for Toxic Substances and Disease Registry and the National Institute of Environmental Health Sciences. Conference topics include: A panel of federal, state and local programs; Epidemiology, Health Effects, Registries and Risk Assessment: Issues, Methods and Reports on Findings; Toxicology and Basic Research: Panel on Future Directions; Protecting Hazardous Waste Workers: Health Issues; Exposure Assessment; Community Right to Know; Health Effects at Waste Sites: Legal Issues; and How Can We Improve the Public Health Impact of Superfund? The Conference Committee is co-chaired by Denny Dobbin of the National Institute of Environmental Health Sciences and Henry Falk from the Center for Environmental Health and Injury Control at the Centers for Disease Control. Advance Registration fees for the conference are $75.00 for SOEH members and $125.00 for non- members. On site registration fees are $125.00 for SOEH members and $175.00 for non-members. The registration deadline is April 15, 1988. For additional information on the conference please contact the Society of Occupational and Environmental Health at P. O. Box 42360, Washington, D. C. 20015- 0360. The Society can be reached at (301) 762-9319. 9 ------- SYMPOSIUM ON ASSESSING THE RISKS FROM TOXICS IN THE NORTHERN CALIFORNIA ENVIRONMENT What can science tell us? Friday, April 8 and Saturday, April 9, 1988 Sponsored by: California Academy of Sciences, U.S. Environmental Protection Agency, Northern California Chapter of the Society for Risk Analyses This two-day symposium brings scientists from the Science Advisory Board and the staff of EPA together with California scientists to discuss problems of risk assessment and risk management for toxic substances. Contact California Academy of Sciences (415) 750- 7217 SCHEDULE FOR RISK AND DECISION-MAKING COURSES The following is the schedule for the Risk and Decision Making Course through the end of May. February 24 and 25 February 29 and March 1 March 1 and 2 March 24 and 25 March 30 and 31 April 6 and 7 April 13 and 14 April 20 and 21 April 26 and 27 May 11 and 12 May 18 and 19 May 25 and 26 Region V Region VII Region IV Headquarters Headquarters Headquarters Headquarters Headquarters Headquarters Headquarters Headquarters Headquarters Contact: Pam Stirling, FTS 382-2747 SYMPOSIUM ON COMMUNICATION EVALUATING RISK What is your communication program trying to accomplish? Is your communication program working? What evaluation methods are most appropriate for your program? These and other questions will be addressed by the Workshop on Evaluation of Effective Risk Communication to be held on June 2 and 3,1988, at the Hyatt Regency Hotel in Washington, D.C. The Workshop is intended to provide guidance to communication practitioners on how to evaluate their programs. Dr. Vincent Covello of the National Science Foundation, Dr. Ann Fisher of the EPA Office of Policy Analysis, and Ms. Rose Mary Romano of the National Cancer Institute are the Workshops Co-chair- persons. The Workshop is being held under the auspices of the Interagency Group on Public Education and Communication, chaired by Dr. Maria Pavlova (EPA Region II, currently on detail to the Office of Toxic Substances), which is a sub-committee of the Task Force on Environmental Cancer and Heart and Lung Disease. Congress established the Task Force to promote interagency cooperation and coordination in reducing and preventing environmentally related diseases. Chaired by Lee Thomas, the Task Force now includes 15 federal agencies as members. The June 1988 Workshop is a continuation of the Workshop on the Role of Government in Risk Communication and Public Education, also sponsored by the Task Force and held in January 1987. The earlier Workshop focused on federal agency public education and risk communication programs that communicate information about health risks associated with exposure to toxic substances. The proceedings of that Workshop are now in press and should be available in the late spring. To provide the context for the June Workshop on Evaluation and Effective Risk Communication, papers have been commissioned from experts in both the theory and practice of evaluation. Drs. Peter Rossi and Richard Berk will review the purposes and procedures of evaluation research as an introduction to the field of evaluation and the methodology used in various problem situations. Ms. Elaine Bratik Arkin will discuss the application of evaluation in theory and methods to risk communication programs in order to "demystify" evaluation for practitioners and relate evaluation processes to problems faced by risk communication program planners. The agenda for the Workshop on Evaluation and Effective Risk Communication has been structured to facilitate interactions among speakers and attendees. Panels of practitioners will discuss how they used evaluation methods in their programs, how evaluation methods relate to risk communication programs, and typical problems in evaluation of risk communication programs. Small workshop sessions will feature discussion of evaluation methods, using case studies, and other practical aspects of evaluation, including obstacles, understanding OMB procedures, matching your needs with evaluators' capabilities, and deciding on the extent of evaluation. Market researchers and those who wish to share examples of evaluations of risk communication programs will be invited to sponsor poster sessions. Contact: Maria Pavlova, FTS 382-3801. NEXT MEETING OF REGIONAL RISK ASSESSORS Region III is sponsoring the next Regional Risk Assessment Conference, which will be held from the morning of June 27 to mid-day June 29 in Philadelphia. The conference will be at the Sheraton Society Hill at 1 Dock Street in Philadelphia. The Region has reserved a block of 70 rooms (at government rates for EPA employees). The government rate for food and lodging in Philadelphia is $107. To get this rate, you must reserve by April 1 (at 215-238- 6000). 10 ------- A group of scientists from different Regions is developing the conference agenda, a draft of which includes these topics: (1) examples of Regional human health risk assessments, (2) examples of Regional ecological risk assessments, (3) Headquarters' new directions in dose-response assessment, (4) examples of how different Regional programs use risk assessment, and (5) Regional risk assessment organizational structures. More details on the conference will be available soon. Contact: Roy L. Smith (FTS 597-9857) Contacts: Jerome Puskin, OAR-Rad., FTS 475-9640 Dorothy Patton, ORD, FTS 475-6743 Linda Tuxen, ORD, FTS 475-6743 Dick Hill, OPTS, FTS 382-2897 Don Barnes, OPTS, FTS 382-4126 Dean Hill, NEIC, FTS 776-8138 Marian Olsen, Region II. FTS 264-5682 Roy Smith, Region III. FTS 597-9857 Dave Dolan, Region V, FTS 886-6195 Jill Lyons. Region VI. FTS 255-7208 Bob Fenemore, Region VII, FTS 757-2970 Arnold Den, Region IX, FTS 454-0906 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 382-5639. Your colleagues from other offices who have information or advice will be able to contact you with assistance. 11 ------- ------- |