UNITED STATES ENVIROMiNTAL PROTECTICN A3ENCY Region II, New York, New York 10271 DATE SUBJECT FRCM September 12, 1988 Risk Assessment Review Deputy Regioni1 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 coninunity 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 Comsittee members listed on page 1 of the rev i ew. At t achment ------- August 1988 Highlights • Third Regional Risk Assessment Conference p. 1 • News from the Risk Assessment Forum ... p. 1 • Section 313 Risk Screening Guide p. 2 • OSWER Bulletin Board System p. 3 • Proposed Agenda for the Next Risk Assessment Meeting p. 5 I. Special Feature The Third Regional Risk Assessment Conference by Roy L Smith (FTS 597-9857) Region III hosted the Third Regional Risk Assessment Conference on June 27-29, 1988, in Philadelphia. EPA participation was impressive: 180 people attended, 100 of whom traveled from other Regional offices or from Headquarters. Everyone enjoyed the area's historic sites and fine food and judged the hotel facilities to be first-rate. The conference was further blessed with the finest June weather in the memory of any living Philadelphian. The conference had dual goals: (1) to present current information and research pertaining to risk assessment, and (2) to encourage the exchange of ideas among conference attendees. An ad hoc body of Regional scientists planned the event over a six-month period. This committee first designed a rough agenda with five major topics, then expanded each topic into a half-day session. One committee member volunteered to moderate each session, which included developing the agenda and recruiting speakers. The phone and E-mail charges from this process remain a well-kept secret. Despite an early start on a Monday morning, the conference was crowded. The first session took aim at the formidable dilemma of assessing exposure to pollutants in soil. Speakers described research into amounts of soil actually eaten by children, proportion of contaminants absorbed through the gut, effects of metal speciation on absorption, and prediction of soil toxicity by biomonitoring. This highly technical session showcased new research for those already familiar with soil exposure. The Monday afternoon session featured selected risk assessments performed by Regions, emphasizing precedent-setting work. These talks described risk from chemicals volatilized from tap water, PAH mixtures, and contaminated seafood. The status of Headquarters' draft guidance for fish tissue risk assessment was discussed, and Region V proposed a new approach for seafood consumption advisories. This session introduced agency scientists to the broad range of possibilities of risk assessment, and to precedents already set by other Regions. On Tuesday morning, we discussed risk-related organizational issues, including quality assurance, use of the new Regional positions, training, providing the (See Conference p.2) 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 II. Headquarters News From the Risk Assessment Forum By Una a C. Tuxen (FTS 475-6743) ARSENIC - In November 1987, the Risk Assessment Forum (Forum) completed a reassessment of the cancer risk associated with the ingestion of inorganic arsenic. The "Special Report on Ingested Inorganic Arsenic: Skin Cancer; Nutritional Essentiality" focused on arsenic-induced skin cancer, including some aspects of the pathology of arsenic-associated skin lesions, the genotoxicity of arsenic, metabolism, body burden and distribution, and the possibility of threshold effects. The Report, which was extensively peer-reviewed by outside experts, concluded that, based on the scientific data available and in keeping with the Agency's Risk Assessment Guidelines, the cancer potency (slope factor) for human ingestion of inorganic arsenic should be in the range of 3 to 7 x 10"5 (yg/L)"1. Based on its review of the Forum's Report, the Risk Assessment Council (Council) developed guidance for Agency decisions on the skin cancer risk from ingestion exposure to arsenic. The Council recommended that to facilitate implementation of the reassessment, and for the purposes of consistency in risk assessment, a single cancer potency value of 5 x 10-5 (jig/L)-1 be used. The Administrator requested Science Advisory Board (SAB) review of the Council's science policy statement at a February 1988 SAB meeting. The SAB's Environmental Health Committee advised the Council that the issue, as presented, was primarily a policy question and was beyond the scope of SAB activities. The SAB declined comment for these reasons. In a June 21, 1988, memorandum to all Assistant Administrators, the Administrator adopted the Council's recommendation that a single cancer potency value of 5 x 10"5 (ug/L)*t be used for ingested inorganic arsenic cancer risk assessments. Also, the memorandum states that "... the Council believes that the uncertainties which are currently unresolvable on a scientific basis are best accounted for in the risk management portion of the decision-making process. Specifically, on a case- specific basis, the Council recommends that risk managers reach their judgments in light of the knowledge that: 1. Ingested inorganic arsenic is a class A carcinogen resulting in an increased incidence of skin cancers. (See Forum p.2) 1 ------- Conference (Continued from p.1) deluge of information mandated by SARA Title III, and EPA-state communication. Animated discussions followed all the presentations. The most noteworthy of these was a sharp exchange between Headquarters and Regions regarding quality assurance. Headquarters scientists urged improvements in the quality and consistency of EPA's risk assessments; Regional scientists fretted that decisions would be delayed or second-guessed. The discussion suggested a need for more communication before going further with quality assurance. On Tuesday afternoon, attendees heard about proposed reductions in the carcinogenic potency slopes of 2,3,7,8-TCDD, arsenic, and methylene chloride, chemicals which have loomed large in Regional risk assessments. Listeners were conscious of implications to past and future Regional decision-making. Each proposal relied on new or re-evaluated chemical- specific information, interpreted under little-used but important flexibility provisions in the EPA Risk Assessment Guidelines. We also had a glimpse of RiskTools, a PC-based risk assessment program under development by the Office of Health and Environmental Assessment. The program requested expert input, then performed the exposure assessment and risk characterization calculations, permitting the expert to see immediately the effects of different input assumptions. The last session, Wednesday morning, centered on the development of ecological risk assessment. Attendees heard about projects to rank risk to ecosystems across programs in Regions I, III, and X (the "Cross-Media" projects), and the efforts of Headquarters program offices (including Office of Policy, Planning and Evaluation; Office of Pesticides and Toxic Substances, Office of Research and Development, Office of Solid Waste and Emergency Response, and the Environmental Research Laboratory in Athens, Georgia) to develop guidance for ecological risk assessment. One of the major accomplishments of this session was to introduce these groups to one another, perhaps reducing future wheel-reinvention. The conference was judged a success on many levels, and in need of improvement on others. It achieved its goal of bringing EPA scientists and managers up to date on a variety of topics, and also provided some unforeseen Region-Headquarters dialogue. EPA's science policy makers found time to attend, and to talk with Regional policy fulfillers. Their dialogue will hopefully continue, and influence the evolution of Agency thinking. Some things will be better next time. The conference should have been longer or have had a less ambitious agenda. There was too little time for discussion and no time for informal meetings among those interested in particular subsets of the risk assessment process. Some sessions ran overtime, shortening breaks and removing what small chance existed for impromptu discussion. The Fourth Risk Assessment Conference, by the way, is tentatively scheduled for Seattle in May, 1989. Contact Pat Cirone (FTS-399-1597) with suggestions, or for information. A proposed agenda and more information is provided on p. 5 of this review. I thank the dedicated people who prepared and presented the conference. The session chairs, Jim Baker (then of Region VIII, now of Jacobs Engineering in Pasadena, CA), Pat Cirone (Region X), Milt Clark (Region V), Bruce Molholt (Region III), and Bill Muszynski (Region II) were superb. The other planning committee members, who freely gave their time and ideas, were Marian Olsen (Region II), Elmer Akin (Region IV), Bob Fenemore (Region VII), Suzanne Wuerthele (Region VIII), Arnold Den (Region IX), and Dana Davoii (Region X). Stan Laskowski (Region III) located funds for the conference, and delivered a fine keynote address. Jayne Dahm (Region III), contract wizard, obtained world-class facilities at government rates. Thanks are also due to more than thirty speakers for excellent talks and the prior hard work. Pencil in Seattle for next May, and start thinking about travel plans. We'll see you there! FOfUtn (Continued from p.1) 2. Only a fraction of the arsenic-induced skin cancers are fatal. 3. The non-fatal skin cancers remain of some concern. 4. The dose-response curve for the skin cancers may be sublinear, in which case the cancer potency in this Report will overestimate the risks. 5. Arsenic may cause cancer in internal organs. 6. Arsenic is a possible but not proven nutritional requirement in animals. There are no direct data on the essentiality of arsenic in humans." A Forum publication containing the full text of the Administrator's memorandum on the Council's policy recommendations is being prepared for printing. Announcement of its availability will be made in a future issue of the Risk Assessment Review. Section 313 Risk Screening Guide David Klauder (FTS 382-3628) In a previous article (March 22. 1988, Risk Assessment Review), background was provided on the development of The Risk Screening Guide by the Office of Toxic Substances. As described earlier, this manual is intended to provide guidance to those who will be evaluating Section 313 emissions data for the purpose of making statements about the potential for health and/or ecological effects. Specifically, it suggests steps that can be taken to answer two key issues of concern regarding Section 313 emissions data. • How can one respond effectively to health and ecological inquiries from the public? • How can the releases of greatest potential concern from a public health or environmental standpoint be 2 ------- identified from the thousands of forms submitted so that these critical cases can be further investigated? Concerning the first issue, this manual offers guidance in responding to risk-related questions that the public will likely ask when the data are made available (e.g., "How dangerous for my health are these specific releases?"). General strategies for handling inquiries, tracking phone calls, assembling resources, and disseminating information are presented. To address the second issue, the manual describes an approach for using Section 313 data as a supplement to existing federal, state and local programs to set priorities for follow-up data collection. The approach should also provide the user with an understanding of what kinds of information need to be collected in order to do a more detailed quantitative risk assessment. While health officials want to be responsive to every site that poses a potential problem and every question from a concerned citizen, it would be impossible to treat them all equally. Therefore, this manual presents an approach to prioritize those chemicals or sites that appear to pose the most immediate or serious concerns. The Risk Screening Guide (Interim Final) contains a set of appendices which comprise a directory of resources including EPA Region and state Section 313 contacts, guidance on estimating likely rates of release for certain chemical uses, and a toxicity ranking matrix for Section 313 chemicals. In addition, a hard copy version of Roadmaps, a supplementary Section 313 chemical information directory, is attached to the guidance manual. Roadmaps also exists as a menu-driven PC data base on five floppy diskettes. This tool was designed by the Office of Toxic Substances as a pointer to pertinent Section 313 chemical-specific information including health and ecological effects data, federal and state regulations and standards, and state air and water program contacts. A final version of The Risk Screening Guide is to be prepared and widely distributed prior to EPA's release of the 1987 emissions data to the public in the spring of 1989. The current version of the guidance manual (September 1, 1988, Interim Final) is under field test in the EPA Regions, selected state and local governments, and in community service organizations. The final document will reflect comments and suggestions for improvement from participants in the field test. For further information on what risk-related conclusions can and cannot be drawn from Section 313 data alone or for copies of The Risk Screening Guide (Interim Final), contact Dr. David S. Klauder, TS-778, U.S. EPA, 401 M St., S.W., Washington, D.C.. (202) 382-3628. The OSWER Bulletin Board System - Update for the Risk Conference Larry J. Zaragoza (FTS 475-9829) In order to better serve the needs of Agency risk assessment specialists, the Risk Conference of the OSWER bulletin board is making several changes. First, information of general interest on risk-related issues that should or will be available to the public is to be moved to the main board. This will complement information from other risk related areas such as the activities of the Contract Lab Program. Second, the risk conference will have a membership requirement that all members be Federal employees. Contractors who wish to access the board will need the name and password of their sponsor in order to access the conference. This modification should aid in targeting material in this conference for the regional risk assessment contacts and risk assessment specialists that exist within the Agency. We would like to encourage users to place questions on the Risk Conference. General and specific questions can either be directed to the members of the conference (public message) or can be directed to the System Operator (SYSOP). The SYSOP has the ability to redirect questions to specific specialists. Currently, Peter Tong and other members of the Toxics Integration Branch (Superfund) address a number of risk-related questions by phone. It is our hope that we will be able to address questions using the risk conference more efficiently through a combination of phone and bulletin board responses. As such, we would like to encourage users to leave information requests so that they might be directed to Peter and other OSWER staff who can offer their experience and expertise. It should also be noted that other offices may be brought in to better address some questions. The figure provided on the next page is a sample PC screen for accessing the bulletin board using CROSSTALK. The initial settings may require some adjustment for your needs. For example, if you are in one of the regions, the first digit 9 in the phone number (NU) should be replaced with 4 digits 8202 or 8301. In addition, should you have a 1200 baud modem rather than a 2400 baud modem, in which case the baud rate (SP) would require adjustment. User support for Crosstalk questions can be obtained from the Washington Information Center at 202-488-5900. User support for questions related to the bulletin board should be directed to Environmental Management Support Incorporated at 301-589-5318. Suggestions relating to the contents of the risk conference should be directed to Larry Zaragoza at 202-475-9829 or through a message on the bulletin board system. Finally, we are in the process of upgrading the system so that more lines will be available and busy signals unlikely. Pat Mundy Office of Emergency and Remedial Response Office of Solid Waste and Emergency Response Larry J. Zaragoza Office of Program Management and Technology Office of Solid Waste and Emergency Response 3 ------- Sample Status Screen for accessing the bulletin board system CROSSTALK - XVI STATUS SCREEN NAme OSWERBBS LOaded C:OSWERBBS.XTK ^Umber95898366 CApture Off Communication Parameters Filter settings SPeed 2400 PArity None Duplex Full DEbug Off LFauto Off DAta 8 STop 1 EMulate VT-100 TAbex Off BLankex Off POrt 1 MOde Call INfilter Off Outfitter On Key Settings SEnd control settings ATten Esc COmmand ETX ("C) CWait None SWitch Home BReak End LWait None Available command files 1) OSWERBBS 2) E-Mail Research on Risk Communication from Tufts University Center for Environmental Management By Margaret Chu (FTS 382-7335) Risk communication - the way in which people learn and express concern about environmental hazards, such as a contaminated water supply or a waste dump site - - has recently emerged as an important environmental issue with far-reaching social and political effects. Research sponsored by the Office of Research and Development (ORD) of the U. S. Environmental Protection Agency at the Center for Environmental Management is looking at the various factors that play a role in the processing of risk information, and will suggest effective strategies for government, industry and community response to environmental risks. In Phase I of the research, Ors. Sheldon Krimsky and Alonzo Plough, both of the Tufts University Urban and Environmental Policy Department, conducted extensive review of the literature of 5 cases where citizens were involved in environmental-risk situations. The five case studies are: (1) The release of genetically modified organisms into the environment: The Case of Ice Minus, (2) A Natural Environmental hazard: The Case of Radon, (3) Pesticide Residues in Food: The Case of EDB, (4) An Industrial Plant: The case of the ASARCO/Tacoma Copper Smelter Tacoma, Washington, and (5) A Hazardous Waste Site: The Case of Nyanza. The outcome of the five case studies will be published in the book "Environmental Hazards: Communicating Risks as a Social Process" scheduled for October 1988 release. Please contact Kurt Fischer (CEM) at (617) 381-3466 for ordering information, or place orders from the Auburn House Publishing Company at 1- 800-223-BOOK. In Phase II of their research, Krimsky and Plough will test the effectiveness of citizen-derived risk communication. Using radon as a case, the project will test a citizen- derived risk communication model. The model involves developing risk information that is based on community interests and guided by citizen perceptions, using personal narratives in conjunction with technical information. Current approaches to risk communication focus on the timeliness and clarity of the message, and seek to improve the scientific literacy of the target group by teaching people about comparative risk assessment. However, this tends to overlook the fact that people do not make decisions on a cognitive basis alone, but need time to absorb the information, to "reckon with the risk." In this phase of the study, focus groups, made up of representatives of risk groups, will be guided by experts, facilitators and others to identify the key issues and produce an approach to risk notification. The approaches developed by these experts, and by the public, will be compared for the amount of trust citizens place in the process. The researchers also hope to determine how well citizens understand the risk, how well citizens are able to act on the information, and overall satisfaction with the process. The next phase of the research will apply the findings to further develop the model for effective risk communication under SARA Title III. For further information, please contact the EPA Technical Monitor Dr. Margaret Chu at FTS 382-7335. 4 ------- III. Around the Regions Region X Region li Bioassessment Work Group A Bioassessment Work Group has been formed in Region II to provide Superfund Site Managers with technical support in the assessment of ecological and environmental effects at sites within the Region. The group offers expertise in evaluating potential biological receptors, extent of contamination, environmental fate, migration pathways, and overall environmental impacts of pollutants at sites, it also assesses potential ecological impacts of proposed remedial and removal actions. The Bioassessment Work Group is comprised of staff from Region li s Environmental Services, Water Management, Emergency and Remedial Response Divisions and Office of Policy and Management, as well as representatives from the National Oceanographic and Atmospheric Administration, the Department of Interior and involved state agencies. The group is chaired by Roland Hemmett, Chief of the Environmental Services Division's Ambient Monitoring Section. The Region II group is patterned after Region Ill's bioassessment group, which has been operating for about two years. Regions I, IV, VIII, and IX are in the process of establishing similar work groups. For further information or to seek input on a specific site, contact the group's coordinator, Mark Sprenger, at FTS 340-6998 or (201) 906-6998. Contact: Mark Sprenger (FTS) 340-6998 Regional Risk Assessment Meeting, Seattle Washington, May 1989 The next regional risk assessment meeting is tentatively scheduled for May, 1989 in Seattle, Washington. The following is a proposed agenda for the meeting and we would appreciate any comments or suggestions for other topics you might wish to discuss at the next meeting. PROPOSED AGENDA DAY 1 Headquarters Guidance and Scientific State of Art Examples: RCRA-CERCLA Interphase Thyroid Neoplasia Superfund Research Centers IRIS Update Technical Centers DAY 2 Regional Human Health Risk Assessment Issues Examples: Acceptable Risk: NESHAP Rule on Benzene Bioavailability: Metals in Soil Dose Response Estimates for Lead in Soil Region IV The third presentation of the Risk Assessment and Decision Making Workshop in Region IV was held August 23-25, 1988. All lecturers and facilitators were regional staff members with expertise in risk assessment, risk management, and risk communication. In addition to regional staff attendees, the seven Office of Research and Development (ORD) laboratories/programs in Region IV were invited to send a participant to foster ORD/regional interaction. Five sent technical or managerial persons from their organizations. Facilitators from seven of the eight states in Region IV were trained during the March Workshop. The state of Florida will present the workshop on site in September with the assistance of two Region IV facilitators. A Public Health Evaluation (PHE), a risk assessment, has been conducted by Region IV staff for a National Priorities List site in Tennessee as part of the Remedial Investigation (Rl) performed inhouse. The Rl document containing the PHE is now under review. Contact: Elmer Akin (FTS 257-3454) DAY 3 Regional Ecological Risk Assessment Issues Examples: Sediment Criteria Short Term Bioassays DAY 4 AM Training and Administration Chaired by Lead Region Examples: State Risk Assessment Procedures Risk Communication Training Please submit ideas to P. Cirone or D. Davoli at E-Mail box EPA9050. Contact: Dana Davoli (FTS 399-2135) 5 ------- IV. Announcements Contacts: Schedule for Risk and Oec/sion-Mafring Courses The following is the schedule for the Risk and Decision Making Courses through September. Headquarters Region IV Region VII Region VII* Region VII Headquarters Region VI Headquarters Region IX Region VIII (Utah) August 17-18 August 23 - 25 August 24 - 25 September 6 September 7 - 8 September 13-14 September 14 - 15 September 21 - 22 September 27 - 29 September 28 - 29 " Special seminar for clericals. Contact: Pam Stirling (FTS 382-2747) Jerome Puskin OAR-Rad. FTS 475-9640 Linda Tuxen ORD-RAF FTS 475-6743 Dick Hill OPTS FTS 382-2897 Don Barnes SAB FTS 382-4126 Dean Hill NEIC FTS 776-8138 Marian Olsen Region II FTS 264-5682 Roy Smith Region III FTS 597-9857 Elmer Akin Region IV FTS 257-3454 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 Dana Davoli Region X FTS 399-2135 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. 6 ------- |