UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Region II, New York, New York 10278 DATE: September 20, 1990 SUBJECT; Risk Assessment Review FROM: szvns Deputy Regional A William J. P.E. nistrator William Farland, Ph.D. y / /TV, Director (//C Office of Health and Environmental 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 Network. 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 fourth 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 further issues, contact one of the committee members listed on page 1 of the Review. Attachment ------- August 1990 Highlights The Plight of the Dolphin p. 1 Risk Assessment Methodologies: Comparing State and EPA Approaches . p. 1 ORD Electronic Bulletin Board System .... p. 3 Region II - CHEMINDX Database p. 3 Region IX - A New Risk Communication Training Aid p. 4 I. Special Features The Plight of the Dolphin by H. George Keeler (FTS 255-2252) This is the eighth in a series of articles describing activities of the Regional Scientist Program operated by the Regional Operations Staff, Office of Technology Transfer and Regulatory Support (OTTRS)/Office of Research and Development. Most activities of the Regional Scientists can be categorized as supporting each Regional Office's functions dealing with the ORD budget planning system, participating in the Regional Applied Research Effort (RARE), providing technical assistance, and expediting technology transfer of new ORD products. As insipid as this may sound, new and exciting challenges do confront the Regional Scientists as was recently the case in Region VI. Starting in January 1990, the marine mammal stranding networks (organized groups making weekly shoreline inspections) in the Gulf States noted an increased mortality rate in dolphins compared to the four previous years. Mr. Myron Knudson, Director of the Water Management Division, was aware that the National Oceanographic and Atmospheric Administration had initiated an investigation into the matter and requested that ORD play an active role in assessing the problem and in keeping both Regions IV and VI informed of any new developments. The first major incident occurred in East Matagorda Bay, Texas, where almost thirty dolphin carcasses were discovered within a few days. The animals were necropsied by Dr. George Miller from the Naval Oceans Systems Center in San Diego. Initially the deaths were thought to be attributable to severe cold weather in the region. Subsequently, dolphins continued to strand from the Florida panhandle to Texas throughout February and March at above normal rates. A total of 264 animals was recovered during the three-month period with 161 of those being in the Texas coast. The totals for these months were the highest on record. The investigation of the current strandings, which is quite thorough, is organized into seven separate areas. Four of the areas concern population biology and include: population abundance and trends: stock identification; age structure of stranded animals; and food habits. The other areas relate to extent and causes of mortality and include studies of biotoxins; con- taminants; pathology (including bacteriology and virol- ogy); and efforts to recover stranded animals. see Plight p.2 Risk Assessment Review Committee Bill Farland - ORD, FTS 382-7317 Sally Edwards - Region I, FTS 835-3696 Maria Pavlova - Region II, FTS 264-7364 Marian Olsen - Region II, FTS 264-5682 Suzanne Wuerthele - Region VIII, FTS 330-1714 Dana Davoli - Region X, FTS 399-2135 Risk Assessment Methodologies: Compering State and EPA Approaches by Bob Cantilll (FTS 382-5546) Ed Ohanian (FTS 382-7571) During the biannual meeting of the Federal-State Toxicology and Regulatory Alliance Committee (FSTRAC) held on April 19 to 20, 1990, the U.S. Environmental Protection Agency conducted a special workshop to discuss current risk assessment method- ologies (see the December 1989 issue of the Risk Assessment Review for more detailed information on the FSTRAC program). The Risk Assessment Workshop brought EPA and the states together to address various technical issues stemming from present risk assessment methodologies for drinking water contaminants. Both state and federal regulatory agencies perform risk assessment every day, but, because of different regu- latory mandates and associated responsibilities, they often have varying perspectives on risk issues. State representatives had the opportunity to hear first-hand the discussion of the issues related to revising the 1986 Guidelines for Carcinogen Risk Assessment and the . Guidelines for the Health Risk Assessment of Chemical Mixtures, as well as developing non-cancer risk assessment guidelines. The FSTRAC Risk Assessment Workshop brought several issues to light. One such issue was the complexity of risk assessments due to such factors as hazard assessment, dose-response evaluation, exposure assessment and risk characterization. Workshop partici- pants discussed whether differences between animals and humans affect the usefulness of biomarkers and concluded that more research is needed to evaluate the use of biomarkers as endpoints and as indicators of exposure. Also, participants discussed whether com- pounds should be regulated more strictly for one exposure route if that compound poses a risk via another route. Participants also discussed the assumptions and limitations of EPA's existing method for calculating the Reference Dose (RfD). The limitations associated with the use of the No-Observed-Adverse-Effect Level (NOAEL), uncertainty factors, and risk at levels higher than the RfD were some of the issues identified by workshop participants as needing further attention. Research currently being conducted to address these issues focuses on incidence and effect modeling, severity modeling, and analyzing probability and density distribution of RfD values. Workshop speakers described see Methodologies p.2 1 ------- Plight (Continued from p. 1) Services for the investigation are being provided by a variety of agencies, institutions and other groups and individuals. Assistance has been provided by: Armed Forces Institute of Pathology; Cooperative Institute for Marine and Atmospheric Sciences; Florida Department of Natural Resources; Greenpeace; Kansas State University; Oak Ridge National Laboratory; Sea World, Orlando, Florida; Texas A&M University; the laboratories of the Southeast Fisheries Science Center, and others. Since there was a concern that the deaths may be associated with environmental pollution, ORD's Narragansett laboratory was asked to join in the investigations. Dr. Ramona Haebler was selected to head up the Agency's efforts. To date, chemical residue analysis of tissue samples from these animals has been constrained by the fact that the research effort was unscheduled and discretionary funds were not available. As a result, I champion support for this study (S50K) from interested parties in Region IV, the coastal states, and other ORD and Agency Operating Program Offices. A collaborative study regarding a previous mass mortality of Bottle-nosed dolphins in the Atlantic during 1987-1988 was conducted by ERL-Narragansett, ERL- Duluth and the Smithsonian Institution. Preliminary findings showed that the tissue from these dolphins contained a broad range of anthropogenic substances including polychlorinated biphenyls and polybrominated flame retardants. There was evidence of biomagnification in the food chain with the highest concentration of the compounds being found in the fatty tissue of this mammalian species. When the females lactate there is a substantial transfer of these compounds to their young. It is hypothesized that although the organic constituents may not be the direct cause of the mortalities, they may well be contributing to the suppression of the immune systems, leaving them highly susceptible to infections. This limited information leads to the conclusion that there is a problem in the near coastal waters of the U.S. that, in time, could result in increasing the mortality rate of young Bottle-nosed dolphins to a level where the elimination of that species from its habitat is possible. It is therefore imperative that we not only carry out the Gulf of Mexico study but continue to monitor and use this species as an indicator of the health of our marine environment. Should you have idle discretionary funds that could be utilized to support this important eco-toxicity investiga- tion, call Dr. Haebler at FTS 838-6154. Methodologies (continued from p. 1) proposed novel approaches to noncancer risk assess- ment; for example, the benchmark approach, which uses the upper 95% confidence limit of the dose-response curve, rather than the NOAEL, to calculate the RfD. The states were encouraged to provide input to EPA regarding the RfD by identifying problems or missing data in EPA's Integrated Risk Information System (IRIS), suggesting chemicals for the RfD Work group to discuss, or sending any toxicity studies or other research projects on any of the existing IRIS files to EPA's RfD Work Group. At the workshop, state representatives provided their perspective on the inhalation Reference Concentration (RfC). The RfC may be more precise than the oral RfD, since it incorporates physiological and chemical-specific data. Concerns were aired regarding the need to revise existing drinking water regulations to account for potential inhalation exposure that may occur during showering and bathing. New regulations also would be affected by the RfC. It was recommended that EPA produce oral RfDs and inhalation RfCs together, using a consistent set of pharmacokinetic and pharmacodynamic assumptions; if this is not possible, EPA could provide information that allows consistent assessment. Workshop participants learned that EPA's Office of Health and Environmental Assessment (OHEA) is revising the 1986 Guidelines for Carcinogen Risk Assessment, with the goal of improving the structure of the guidance so that the risk assessor has every tool available for assessing and characterizing the risk from carcinogens. During the Risk Assessment Workshop, Dr. William Farland, Director of OHEA, described the issues being addressed for each step of the risk assessment: hazard identification and classification, dose-response modeling, exposure assessment, and risk character- ization. Several of the state participants provided practical input for the current EPA hazard classification scheme. For example, it was suggested that pharmaco- kinetic data be included in the minimum data sets for making the classification determination, especially for potential Group E (non-carcinogenic) chemicals. State representatives also described their concern over the lack of regulatory guidelines or standards for short- term exposures, which could result from spills or unrecognized groundwater contamination. Workshop participants discussed a method for estimating risk from short-term exposure to carcinogens. FSTRAC's Toxicol- ogy/Risk Assessment Subcommittee will be preparing a summary paper outlining issues related to short-term exposures. The subcommittee has asked for input from interested persons. A representative from the EPA Work Group that is updating the 1986 Guidelines for the Health Risk Assessment of Chemical Mixtures discussed assess- ment of risks from exposure to complex mixtures. Such assessments possess many challenges because of the lack of data, and difficulty in applying toxicity tests to real-life conditions. Guideline revisions are focusing on issues such as whether additivity is a reasonable assumption, similarity between mixtures, how to deal with carcinogens, and the role of metal speciation in the composition of mixtures in the environment. A large portion of the Guidelines is dedicated to communicating to the risk manager the assumptions, uncertainties, and "expert judgment" used to arrive at the final assessment. State participants explained that they often regulate mixtures as a single entity, for lack of another way. Any evidence of carcinogenicity for any of a mixture's components is enough to merit labeling the whole mixture carcinogenic - some states regulate the mixtures based on the most toxic component present. 2 ------- Several other issues came up at the workshop. One topic was the role played by the Office of Drinking Water Health Advisories (HAs) in state risk assessments. HAs are short guidance documents that summarize health effects information for drinking water contaminants, usually for chemicals that are not otherwise regulated by ODW. These HAs are helpful to state regulators because they provide guidance to state and local personnel in the absence of other guidance from EPA. EPA is con- sidering several issues related to HAs, such as how to handle complex mixtures, vehicle effects observed in gavage studies, and risk assessment of disinfectants and their by-products. State representatives at the workshop also described the issue of regulating substances for which there are no EPA standards or HAs. In the case of one chemical, methyl-t-butyl ether, one state developed a risk assessment based on aesthetic appearance, taste and smell, as well as health effects. The states suggested that EPA consider a policy to address odor and taste thresholds in human health effects assessments. At the end of the workshop, participants agreed that FSTRAC will continue to be an extremely useful forum for addressing these risk assessment issues of mutual interest. Continued information sharing and discussion among FSTRAC members helps keep state and federal regulators and risk assessors aware of each other's needs and concerns. The EPA Office of Drinking Water is preparing a report summarizing the Risk Assessment Workshop discussions. This report, titled "Risk Assessment Methodologies: Comparing State and EPA Approaches," will be available in the fall of 1990. For information on the report, or on joining FSTRAC, contact Dr. Edward Ohanian, Chief, Health Effects Branch (WH-550D), Office of Drinking Water, U.S. EPA, 401 M Street, S.W., Washington, D.C. 20460 or FTS 382-7571. II. Headquarters ORD Electronic Bulletin Board System (BBS) Open by Jose Perez (FTS 684-7272) The Office of Research and Development (ORD) has created the ORD Bulletin Board System (BBS) to foster communication and technology transfer among EPA staff, state and local officials and staff, researchers, and the private community. The BBS is located in Cincinnati, Ohio, and operated by ORD's Center for Environmental Research Information (CERI). A major feature of the BBS is an on-line, text-searchable database of every ORD publication produced since 1976 (more than 15,000 citations). Each citation includes title, authors, abstract, ordering information and much more. The BBS also offers such features as messages, bulletins of new information, public domain files, and currently has five specialty areas (conferences: water, regional operations, expert systems, biotechnology, and QA/QC). The BBS is open to everyone with immediate access to almost all its features. The BBS is straightforward to use and on-line help is available for those new to BBS systems. To access the ORD BBS, call (513) 569-7610 or FTS 684-7610. Or contact Jose Pงrez of CERI (EMAIL - EPA8111, FTS 684-7272 for additional information.) III. Around the Regions Region II CHEMINDX A Chemical Database for the SARA Program In September 1987 the Pesticides and Toxic Substances Branch located in Region ll's Environmental Services Division in Edison, New Jersey developed a chemical database on a PC in d-BASE III + to support the SARA Title 313 inspection program. The program identified the SARA Title 313 chemicals that were also regulated by other EPA programs. Because of the scope of the program the CHEMINDX database was transferred to a mainframe computer using the software package FOCUS. A description of the CHEMINDX program is provided below. What is CHEMINDX? CHEMINDX is a multi-user, menu-driven, centralized database containing chemical-specific information on over 8,000 chemicals and over 33,000 synonyms. CHEMINDX has information on regulator status, health effects, hazardous qualities, and emergency response for chemicals that are of interest to the various EPA programs. CHEMINDX information is derived from a number of EPA programs (SARA Title 313, RCRA, CERCLA, etc.) as well as non-EPA programs (OSHA, ACGIH, and DOT). Information can be retrieved by using any of several registry numbers such as CAS, RCRA, SHG, PMN, or DOT numbers, as well as by the chemical name. CHEMINDX provides chemical specific regulatory information. For example, under which regulatory and/or statute is a particular chemical of interest, regulated or monitored. In the future, the system will further refine the regulation/statute classifications with chemicals that have been delisted or are under proposal. CHEMINDX can create cross-reference listings of chemicals that are regulated by multiple EPA programs, e.g., chemicals that are regulated by other than the RCRA and SARA statutes. CHEMINDX can provide instruction on the appropriate emergency response for chemical spills based on DOT emergency guidelines. CHEMINDX can provide health-related information based on OSHA and ACGIH information, such as maximum exposure limits. 3 ------- CHEMINDX Segment Summary CHEMINDX is composed of several segments which contain specific data elements: e The REGULATION segment consists of fields describing the various EPA statutes and regulations: Clean Water Act (CWA) Clean Air Act (CAA) Safe Drinking Water Act (SDWA) Resource Conservation and Recovery Act (RCRA) Superfund Amendments and Reauthorization Act (SARA) Toxic Substances Control Act (TSCA) Federal Insecticide. Fungicide and Rodenticide Act (FIFRA) The HEALTH segment consists of: SARA Title 313 carcinogenic profiles (e.g., chronic or acute toxicity) from IRIS, ACGIH, NTP and IARC carcinogenic characteristics. The EMERGENCY segment (based on the DOT guidebook) consists of: Fire or explosion hazards Health hazards Emergency actions First aid measures Spill and leak response The OSHA segment contains information on OSHA and ACGIH health effects (e.g., chemical exposure levels and limits, such as short-term exposure levels, and time-weighted averages (TWA)j The DOT segment contains hazardous information on chemicals: Flammability Reactivity Heath rankings based on National Fire Protection Association (NFPA) DOT toxic liquids RCRA U, P, D, F, K hazardous chemical classifications System Access To access the system, Dial into the EPA communications network via either a data link or telephone modem, Log onto TSO Log onto FOCUS by typing FOCUS At the FOCUS prompt > Type EX CHEMINDX Chemical information can be accessed by either supplying one of several registry numbers, such as CAS, RCRA, PMN, SHG or DOT or by the chemical name. Once the chemical has been identified by using any of the section criteria above, the chemical data can be presented along both program (e.g., EPA programs and statues such as TSCA, SARA, CAA, CWA, SDWA, FIFRA, and RCRA) and topic lines (e.g., health, hazardous, toxicity, carcinogen and water-related information). When CHEMINDX is used in conjunction with the TRI data, there is an opportunity for the region to define inspection targets (including multi-media inspections) based on a risk assessment of the potential harm to the community considering toxicity and volume of chemicals emitted, mechanism of exposure (air and water) and size of population exposed. For further information on CHEMINDX, contact George Nossa, of Region H's Information System Branch at FTS 264-9850 or Ernest Regna of Region It's Pesticides and Toxic Substances Branch at FTS 340-6765. Contact: Ernest Regna (FTS 340-6765) Region IX A New Risk Communication Training Aid A new publication, Public Meeting: Typical Questions & Sample Responses, was recently developed as a response to many requests from students of the Risk & Decision Making and Risk Communication and Public Involvement Courses. Of the over 1,000 state and federal students who have attended the courses, managers and staff alike have continually asked for examples of "good" answers to difficult public meeting questions. While verbal examples have been given during the training, and "good" answers vary depending on the situation, students were still in need of a more permanent reference guide. As a result, a publication was developed to serve as a training aid for our Risk Courses, and as a guide to assist staff in preparing for future discussions with the public. Our purpose in developing this guide was to give students a document that illustrates through examples, the process which they must consider to develop their own "good" answers. In the guide, applications of the seven cardinal rules of risk communication are cited along with ideas for understanding public needs, a critical skill for preparing effective responses. Earlier drafts of the publication were shared with our state and regional staffs. Their responses were very positive, and we would like to offer the final version to the other regional offices and Headquarters Program Offices. We invite comments and suggestions and plan to expand the guide based on the responses we receive. For additional information on the 19-page guide which contains responses to 19 typical public meeting questions, please contact Alvin Chun, Region IX at FTS 556-6529 or Arnold Den at FTS 556-6472. Contact: Alvin Chun (FTS 556-6529) IV. Announcements NACHO Environmental Health Project Short Course on Lead Poisoning September 30, 1990 The National Association of County Health Officials' (NACHO's) Environmental Health Project will sponsor a 4 ------- short course on "Addressing Childhood Lead Poisoning: Breaking the Cycle of the Lead Epidemic" on Sunday, September 30, from 1:00 p.m. to 5:00 p.m. The course will be held at the American Public Health Association 118th annual meeting to be held in New York City at the Sheraton Center Hotel, Georgian Ballroom A. The presentation is co-sponsored by the American Public Health Association's Environmental Section, Association of Occupational and Environmental Clinics, NACHO and the Agency for Toxic Substances and Disease Registry. The short course will cover recent findings in childhood lead poisoning and their practical implications for those working to protect the public's health. Topics to be covered include: Historical perspectives and the current and emerging issues surrounding the lead epidemic, Sources, routes of exposure, and high and low level health effects of lead exposures, including the implications of recent evidence for public health, Impact of recent findings of low level health effects on existing lead screening programs, exploring options for implementing new programs, and innovative approaches for screening, Clinical manifestations, perinatal effects, clinical interventions, and how health departments can advise private physicians, Updated recommendations for the investigation and diagnosis of environmental exposures, including home visits, sampling and analytical methods, and least cost alternatives of abatement and amelioration of lead in the home, and Strategies for enhancing community and physician knowledge regarding the issues surrounding the lead epidemic. For further information, please contact Jennifer Morrone, NACHO, 440 1st Street, N.W., Washington, D.C. 20001 or call at (202) 783- 5550. 11th Annual SETAC Meeting November 11-15,1990 The 11th Annual Society of Environmental Toxicology and Chemistry (SETAC) meeting will be held from November 11 to 15, 1990, at the Hyatt Regency-Crystal City, in Arlington, Virginia. The meeting will include a number of short courses including: Sunday, November 11, from 9:00 a.m. to 1:00 p.m. Methods in Aquatic Behavioral Toxicology, Testing the Toxicity of Field-Collected Freshwater Sediments, and Risk Communication Workshop: An Introduction to the Principles of Risk Communication. Sunday, November 11, from 2:00 p.m. to 6:00 p.m. Environmental Sciences and Good Laboratory Practice (GLP) Compliance Programs, ฎ Scientists and Engineers Providing Technical Support in Litigation, and Procedures for Regulating Bioconcentrate Toxicants. Monday, November 12, from 1:00 p.m. to 5:00 p.m. History of Aquatic Toxicology - the Making of a Profession. Special sessions at the meeting will include: A Plenary Session by Dr. Thomas Lovejoy, the Assistant Secretary for External Affairs at the Smithsonian Institution. Dr. Lovejoy will speak on global environmental concepts for the 90's. His keynote address will be followed by an international panel of distinguished environmental scientists who will discuss global environmental issues from their region's perspective. On November 13 and 14, 1990, a symposium on Utilization of Simulated Field Studies in Aquatic Ecological Risk Assessment will be held. The use of simulated field studies, such as mesocosms, in aquatic ecological risk assessment is a quickly evolving field of research. These studies represent the "highest tier" in assessing the potential impact of chemicals on aquatic ecosystems and play a vital role in effectively evaluating risk. This symposium will serve as a forum for the exchange of information on the design,. conduct, and interpretation of simulated field studies. On Thursday, November 15, the Surfactant Symposium will cover the subjects of the aquatic and terrestrial toxicology, laboratory and field fate studies, factors influencing bioavailability, analytical chemistry, field monitoring, field toxicity/ ecosystems, and hazard assessments. The Future of Environmental Journalism - a public forum cosponsored by the Society of Environmental Journalists and SETAC will be held on Wednesday, November 14, at 7:00 p.m. A panel of print and broadcast media journalists will discuss new approaches on reporting global environmental issues with audience participation. For additional information on the meeting, please contact SETAC at 1101 14th Street, N.W., Suite 1100, Wash- ington, D.C. 20005. National Minority Health Conference Focus on Environmental Contamination December 4-6, 1990 The Agency for Toxic Substances and Disease Registry will sponsor the National Minority Health Conference - Focus on Environmental Contamination from December 4 to 6, 1990 in Atlanta, Georgia. The conference will be held at the Westin Peachtree Plaza Hotel, located in downtown Atlanta. In 1988, ATSDR proposed a minority environmental health initiative to examine current science issues in three main areas: demographics, health perspectives (e.g., nutritional status, lifestyle and socioeconomic 5 ------- influences, and psychosocial impacts), and health communication/health education. With this conference ATSOR will bring together knowledgeable experts to discuss these areas. A conference registration fee of $50.00 will be charged and reservations must be submitted by November 15, 1990. For additional information on the conference, please contact the Conference Coordinator, Equity Associations, Inc., P. 0. Box 296, Knoxville, Tennessee 37901. For hotel information, please contact the Westin Peachtree Plaza, Reservations Department, P. 0. Box 56650, Atlanta, Georgia 30343-9986. Contacts: Jerome Puskin OAR-RAD FTS 475-9640 Linda Tuxen ORD-OHEA FTS 382-5949 Dorothy Patton ORD-RAF FTS 475-6743 Dick Hill OPTS FTS 382-2897 Don Barnes SAB FTS 382-4126 Dean Hill NEIC FTS 776-8138 Sally Edwards Region I FTS 835-3696 Marian Olsen Region II FTS 264-5682 Jeffrey Burke Region III FTS 597-1177 Elmer Akin Region IV FTS 257-2234 Milt Clark Region V FTS 886-3388 Jon Rauscher Region VI FTS 255-6715 Bob Fenemore Region VII FTS 757-2970 Suzanne Wuerthele Region VIII FTS 330-1731 Arnold Den Region IX FTS 556-6472 Dana Davoli Region X FTS 399-2135 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. 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 6 ------- |