UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF rrn c im* SOLID WASTE AND TLD ~ D J?Q|4 EMERGENCY RESPONSE OSWER Directive 9200.1-120 MEMORANDUM SUBJECT: Human Health Evaluation Manual, Supplemental Guidance: Update of Standard Default Exposure Factors , FROM: Dana Stalcup, Acting DirectorV^^^ ' Assessment and Remediation Division Office of Superfund Remediation and Technology Innovation TO: Superfund National Policy Managers, Regions 1-10 Purpose The mission of the Superfund program is to protect human health and the environment consistent with the Comprehensive Environmental Response, Compensation and Liability Act, as amended, (CERCLA) and as implemented by the National Oil and Hazardous Substances Pollution Contingency Plan. The purpose of this directive is to update the Interim Final Standard Exposure Factors Guidance (1991), which is reflected in the attached table and is to be used: • in the CERCLA remedial investigation and feasibility study process (e.g., assessing baseline health risks, developing preliminary remediation goals, evaluating risks of remedial alternatives), • to evaluate health risks in the CERCLA removal program, and • in the process of five-year reviews of selected remedies. This guidance update supplements the Risk Assessment Guidance for Superfund: Human Health Evaluation Manual, Part A (RAGS, Part A) that was issued October 13, 1989. This guidance supersedes and replaces certain portions of OSWER Directive 9285.6-03, issued March 25, 1991 and updates the Risk Assessment Guidance for Superfund. Part E, issued July 2004 (RAGS, Part E). Other cleanup programs in the Office of Solid Waste and Emergency Response (OSWER) are welcome and encouraged to adopt the recommended exposure factors, much as they have historically adopted other aspects of the Risk Assessment Guidance for Superfund (RAGS). Internet Address (URL) • http;//www.epa.gov Recycled/Recyclable • Printed with Vegetable OH Based Irks on 100% Postconsumer, Process Chlorine Free Recycled Paper ------- Background In September 2011, EPA's National Center for Environmental Assessment, Office of Research and Development (ORD/NCEA) issued a substantive update to its exposure assessment recommendations. Exposure Factors Handbook- 20II Edition, referred to as EFH 2011 herein, provides information and recommendations on various physiological and behavioral factors commonly used in assessing exposure of adults and children to environmental chemicals. ORD/NCEA's recommended values for exposure factors are based on the results of studies deemed to be the most up-to-date and scientifically sound, based upon data available up to July 2011, and incorporates revisions made to the Child-Specific Exposure Factors Handbook, which was last updated and published in 2008. EFH 2011 is not a Superfund-specific document; rather, it provides a summary of the latest developments in exposure science and provides recommendations for a broad range of EPA programs. Following the publication of EFH 2011, regional risk assessors received inquiries from other EPA program offices, states, the regulated community, and other interested parties regarding the applicability of the ORD/NCEA's recommendations for use in human health risk assessments. During the October 2011 to August 2012 period, the OSWER Human Health Regional Risk Assessors Forum (OHHRRAF) reviewed the recommendations in EFH 2011 in the context of the default exposure factors used in the Superfund program and to derive Regional screening levels. As a result of a consensus-driven process, the OHHRRAF identified several Superfund-specific default exposure factors that warranted updating, based upon recommendations from ORD/NCBA in EFH 2011. This guidance incorporates and adopts the updates recommended by the OHHRRAF. Objective This guidance has been developed to reduce variability and uncertainty in the exposure assumptions used by Regional Superfund staff to characterize exposures to human populations for human health risk assessments. Implementation This guidance supplements the Risk Assessment Guidance for Superfund: Hitman Health Evaluation Manual (RAGS), Part A through E, Where numerical values differ from those presented in Part A or E, the factors presented in this guidance should be considered updates to the older values. As new data become available, this Directive may be modified accordingly. This report can be found at wwvv.cpa.gpy/oswer/riskassessmeni/sup_erfiind_hh_cxposurc.htm Please contact Richard Kapuscinski at (703) 305-7411 if you have questions or concerns. Attachment ------- cc: Mathy Stanislaus, OSWER Barry Breen, OSWER Lawrence M. Stanton, OSWER/OEM Barnes Johnson, OSWER/ORCR David Lloyd, OSWER/OBLR Reggie Chcatham, OSWER/FFRRO Carolyn Hoskinson, OSWER/OUST Elliott Gilberg, OECA/OSRE Dave Kling, OECA/FFEO John Michaud, OGC/SEWRLO OSRT! Managers Regional Superfund Branch Chiefs, Regions 1-10 Lisa Price, Superfund Lead Region Coordinator, Region 6 OSWER/OSRTI Human Health Regional Risk Assessors Forum ------- CITATIONS U.S. Environmental Protection Agency (EPA). 201 1. Exposure Factors Handbook 201 1 Edition (Final). National Center for Environmental Assessment, Office of Research and Development, Washington D.C. Currently available on-line at U.S. Environmental Protection Agency (EPA). 2009. Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment). EPA 540-R-070-002, OSWER 9285.7-82. Office of Superfund Remediation and Technology Innovation. Washington, DC. January. Currently available on-line J£Oj/^ U.S. Environmental Protection Agency (EPA). 2008. Child-Specific Exposure Factors Handbook. PA/600/R-06/096F. National Center for Environmental Assessment, Office of Research and Development. Washington D.C. September. Currently available on-line at U.S. Environmental Protection Agency (EPA). 2004. Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment), Final. Office of Superfund Remediation and Technology Innovation. Washington, DC. July. Currently available on-line at ^ U.S. Environmental Protection Agency (EPA). 2001. Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part D, Standardized Planning, Reporting and Review of Superfund Risk Assessments), Final. December. Currently available on- line at htt2i//v^wj.m!^^ U.S. Environmental Protection Agency (EPA). 2001. Comprehensive Five- Year Review Guidance. OSWER 9355. 7-03B-P, EPA 540-R-0 1-007. Office of Emergency and Remedial Response. Washington, DC. June. Currently available on-line at http:/yw\vvv._epa.gov/superfund/acconij)/5\'car/index.htni U.S. Environmental Protection Agency (EPA). 1991. Risk Assessment Guidance for Superfund (RAGS), Volume 1: Human Health Evaluation Manual (Part C, Risk Evaluation of Remedial Alternatives), Interim. Publication 9285.7-01C. Office of Emergency and Remedial Response. Washington, DC. October. Currently available on-line at http://w\¥w.epa.gov/os\veiynskassessmeiit/ragscjindex.htnT. U.S. Environmental Protection Agency (EPA). 1991. Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part B, Development of Risk-based Preliminary Remediation Goals), Interim. EPA 540-R-070/003. Publication 9285.7-01B. Office of Emergency and Remedial Response. Washington, DC. December. Currently available on-line at hUp://\vwwjgpa,gQV/QS_w ------- Attachment 1. Recommended Default Exposure Factors (2014) Symbol Definition (units) Previous Default Value Currently Recommended Value Source of current recommendation Source of previous recommendation Ingestion and Dermal Contact Rates IRWC IRWa IRSC IRSa IR,W I ROW SAsc SA« SAB,, SA« SAwa AFC AFa AFOW BWC BWa BWW Resident Drinking Water Ingestion Rate - Child (L/day) Resident Drinking Water Ingestion Rate - Adult (L/day) Resident Soil Ingestion Rate - Child (mq/day) Resident Soil Ingestion Rate - Adult (mg/day) Indoor Worker Soil Ingestion Rate (mg/day) Outdoor Worker Soil Ingestion Rate (mg/day) Resident skin surface area - child (cm2) Resident skin surface area - adult (cm2) Worker skin surface area - adult (cm2) Resident Water Surface area - child (cm2) Resident Water Surface area - adult (cm2) Resident soil adherence factor - child (mg/cm2) Resident soil adherence factor - adult (mg/cm2) Worker soil adherence factor - adult (mg/cm2) Resident Body Weight - child (kg) Resident Body Weight - adult (kg) Worker Body Weight (kg) 1 2 200 100 50 100 2,800 5,700 3,300 6,600 18,000 0.2 0.07 0.2 15 70 70 0.78 2.5 200 100 50 100 2,373 6,032 3,527 6,365 19,652 0.2 0.07 0.12 15 80 80 U.S. EPA 201 la, Tables 3-15 and 3-33; weighted average of 90th percentile consumer-only ingestion of drinking water (birth to <6 years) U.S. EPA 201 la, Table 3-33; 90th percentile of consumer-only ingestion of drinking water (> 21 years) U.S. EPA 2011a (Table 5-1); "upper-bound values" accounting for both soil and dust ingestior U.S. EPA 199 la (pp. 6 and 15); EFH 2011 only provides a central tendency value U.S. EPA 199 la (pp. 9-10, 15); EFH 2011 values not provided U.S. EPA 199 la (pg. 15), same as adult resident; EFH 2011 value not provided U.S. EPA 201 la, Tables 7-2 and 7-8; weighted average of mean values for head, hands, forearms, lower legs, and feet (male and female, birth to < 6 years)(forearm and lower leg-specific data used when available, ratios for nearest available age group used elsewhere (per EPA 201 lb)) U.S. EPA 201 la, Tables 7-2 and 7-12; weighted average of mean values for head, hands, forearms, and lower legs (male and female, 21+ years)(forearm and lower leg-specific data used for males and female lower leg; ratio of male forearm to arm applied to female arm data). US EPA 2011a, Table 7-2; weighted average of mean values for head, hands, and forearms (male and female, 21+years) (similar assumptions for forearms as used in EPA2011b) U.S. EPA 201 la, Table 7.9; weighted average of mean values for male and female children <6 years. U.S. EPA 201 la, Table 7.9; weighted average of mean values for male and female adults, 21-78. U.S. EPA 2004 (Exhibit 3-5), RAGS Part E U.S. EPA 2004 (Exhibit 3-5), RAGS Part E U.S. EPA 201 la, Table 7-20 and Section 7.2.2; arithmetic mean of weighted average of body part- specific (hands, forearms, and face) mean adherence factors for adult commercial/industrial activities U.S. EPA 201 la, Table 8-1; weighted average of mean body weights (birth to <6 years) U.S. EPA 201 la, Table 8-3; weighted mean values for adults 21 - 78 U.S. EPA 201 la, Table 8-3; weighted mean values for adults 21 - 78 U.S. EPA 1989 (Exhibit 6-11) U.S. EPA 1989 (Exhibit 6-11) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 2002 (Exhibit 1-2) U.S. EPA 2002 (Exhibit 1-2) U.S. EPA 2002 (Exhibit 1-2) U.S. EPA 2004 (Exhibit 3-2) U.S. EPA 2004 (Exhibit 3-2) U.S. EPA 2002 (Exhibit 1-2) U.S. EPA 2002 (Exhibit 1-2) U.S. EPA 2002 (Exhibit 1-2) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) Exposure Frequency, Exposure Duration, and Exposure Time Variables ------- Attachment 1. Recommended Default Exposure Factors (2014) Symbol EFr EFW EFIW EFOW EDr EDC EDa EDW EDiw EDOW ETra ETrs ETW ET« ETrw ETrwc ETrwa Definition (units) Resident Exposure Frequency (days/yr) Worker Exposure Frequency (days/yr) Indoor Worker Exposure Frequency (days/yr) Outdoor Worker Exposure Frequency (days/yr) Resident Exposure Duration (yr) Resident Exposure Duration - child (yr) Resident Exposure Duration - adult (yr) Worker Exposure Duration - (yr) Indoor Worker Exposure Duration (yr) Outdoor Worker Exposure Duration (yr) Resident Air Exposure Time (hours/day) Resident Soil Exposure Time (hours/day) Worker Air Exposure Time (hr/hr) Worker Soil Exposure Time (hours/day) Resident Water Exposure Time (hours/day) Resident Water Exposure Time - child (hours/event) Resident Water Exposure Time - adult (hours/event) Previous Default Value 350 250 250 225 30 6 24 25 25 25 24 24 8 8 24 1 0.58 Currently Recommended Value 350 250 250 225 26 6 20 25 25 25 24 24 8 8 24 0.54 0.71 Source of current recommendation U.S. EPA 199 la (pg. 15); value not provided in EFH 2011 U.S. EPA 199 la (pg. 15); value not provided in EFH 2011 U.S. EPA 199 la (pg. 15); value not provided in EFH 2011 U.S. EPA 2002; value not provided in EFH 2011 EPA 201 la, Table 16-108; 90th percentile for current residence time. U.S. EPA 199 la, Pages 6 and 15 EDr (26 years) - EDc (6 years) U.S. EPA 199 la (pg. 15); EFH 2011 only provides a central tendency value U.S. EPA 199 la (pg. 15); EFH 2011 only provides a central tendency value U.S. EPA 199 la (pg. 15); EFH 2011 only provides a central tendency value The whole day The whole day The work day The work day The whole day U.S. EPA 201 la, Table 16-28; weighted average of 90th percentile time spent bathing (birth to <6 years) U.S. EPA 201 la, Tables 16-30 and 16-31; weighted average of adult (21 to 78) 90th percentile of time spent bathing/ showering in a day, divided by mean number of baths/showers taken in a day. Source of previous recommendation U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) U.S. EPA 1991a (pg. 15) The whole day The whole day The work day The work day The whole day U.S. EPA 2004 U.S. EPA 2004 Miscellaneous Variables; values not provided in EFH 2011 ATr ATW ATiw ATOW Averaging time - resident (days/year) Averaging time - composite worker (days/year) Averaging time - indoor worker (days/year) Averaging time - outdoor worker (days/year) 365 365 365 365 365 365 365 365 U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) U.S. EPA 1989 (pg. 6-23) ------- Attachment 1. Recommended Default Exposure Factors (2014) Symbol LT IRfeh IRproduce Definition (units) Lifetime (years) Fish Ingestion Rate (mg/day) Consumption of homegrown produce (g/day) Previous Default Value 70 5.4 x 104 42 (fruit); 80 (veg) Currently Recommended Value 70 ** ** Source of current recommendation U.S. EPA 1989 (pg. 6-22), pending additional input from NCEA Recommend using site-specific values Recommend using site-specific values Source of previous recommendation U.S. EPA 1989 (pg. 6-22) U.S. EPA 1991a (pg. 15) U.S. EPA 1990 References for Cited Sources: U.S. EPA 1989. Risk assessment guidance for Superfund. Volume I: Human health evaluation manual (Part A). Interim Final. Office of Emergency and Remedial Response. EPA/540/1-89/002. U.S. EPA 1990. Exposure Factors Handbook. Office of Health and Environmental Assessment. EPA/8-89/043, March 1990. U.S. EPA 1991a. Human health evaluation manual, supplemental guidance: "Standard default exposure factors". OSWER Directive 9285.6-03. U.S. EPA 1991b. Risk Assessment Guidance for Superfund. Volume I: Human Health Evaluation Manual (Part B. Development of Risk-Based Preliminary Remediation Goals). Office of Emergency and Remedial Response. EPA/540/R-92/003. December 1991 U.S. EPA. 1996a.Soil Screening Guidance: User's Guide. Office of Emergency and Remedial Response. Washington. DC. OSWER No. 9355.4- 23 http://www.epa.gov/superfund/health/conmedia/soil/index.htmtfuser U.S. EPA. 1996b. Soil Screening Guidance: Technical Background Document. Office of Emergency and Remedial Response. Washington. DC. OSWER No. 9355.4- 17Ahttp://www.epa.gov/superfund/health/conmedia/soil/i ntrotbd.htm U.S. EPA. 1997a. Exposure Factors Handbook. Office of Research and Development, Washington, DC. EPA/600/P-95/002Fa. U.S. EPA 2000. Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds. Part I: Estimating Exposure to Dioxin-Like Compounds. Volume 3— Properties, Environmental Levels, and Background Exposures. Draft Fi U.S. EPA. 2001. WATER9. Version 1.0.0. Office of Air Quality Planning and Standards. Research Triangle Park. NC. U.S. EPA 2002. Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites. OSWER 9355.4-24. December 2002.http://www.epa.gov/superfund/health/conmedia/soil/index.htm U.S. EPA 2004. Risk Assessment Guidance for Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment) Final. OSWER 9285.7-02EP.July 2004. Document and website http://www.epa.gov/oswer/riskassessment/rags U.S. EPA. 2005. Guidance on Selecting Age Groupsfor Monitoring and Assessing Childhood Exposures to Environmental Contaminants. EPA/630/P-03/003F. November. 2005. U.S. EPA 2009. Risk Assessment Guidance for Superfund Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment) Final. OSWER 9285.7-82.2009. U.S. EPA 2011a. Exposure Factors Handbook: 2011 Edition. EPA/ 600/ R-090/052F. September 2011. EPA. 2011b. "Regional Screening Levels (Formerly PRGs), User's Guide." November. On-Line Address: http://www.epa.gov/reg3hwmd/risk/human/rb-concentration table/usersguide.htm Users are directed to the Exposure Factors Handbook (2011) as a source for specific age-group exposure factors as described in EPA, 2005. ------- |