Department of Pesticide Regulation Risk-Assessment Guidance Documents
Priority-Setting and Initiating Risk Assessment
Process for Human Health Risk Assessment Prioritization and Initiation (DPR 2004a)
Final Notice on Active Ingredients Prioritized for Risk Assessment Initiation (DPR 2007)
Prioritization and Status of Active Ingredients for Risk Characterization: Report #52 (DPR 2011a)
Final Recommendations Regarding the List of Active Ingredients Prioritized for Risk Assessment Initiation (Schreider 2014)
DPR Risk-Assessment Guidance
Guidance for Evaluating Genetic Toxicology Studies (DPR 2000)
Guidance for Benchmark Dose (BMD) Approach – Continuous Data (DPR 2004b)
Guidance for Benchmark Dose (BMD) Approach – Quantal Data (DPR 2004c)
A Guide to Pesticide Regulation in California (DPR 2011b)
DPR Risk Assessment Guidance – default uncertainty factors, NOEL and RfC (DPR 2011c, undergoing revision)
Exposure-Assessment Guidance
Guidance for the Preparation of Human Pesticide Exposure Assessment Documents (Thongsinthusak et al. 1993, undergoing revision)
Interim Guidance for Selecting Default Inhalation Rates for Children and Adults (Andrews and Patterson 2000, undergoing revision)
Worker Health and Safety Branch Policy on the Estimation of Short-term, Intermediate-term, Annual, and Lifetime Exposures (Andrews 2001)
Guidance for Determination of Dislodgeable Foliar Residue (Edmiston et al. 2002)
Guidance for Dietary Exposure Assessment (DPR 2009)
Methods for Calculating Short-term Exposure Estimates (Frank 2009a)
Exposure Assessment Policy and Procedure – Default Transfer Coefficients (Frank 2009b, undergoing revision)
Surrogate Handler Exposure Estimates for Use in Assessments by the California Department of Pesticide Regulation (Beauvais et al. 2007, undergoing revision)
Air Monitoring and Methods
Examples of DPR’s recommendations for an ambient monitoring study and ARB’s protocol:
Use Information and Air Monitoring Recommendations for 1,3-Dichloropropene, Methyl Bromide, Chloropicrin, and Methyl Iodide (Oros and Neal 2010)
Sampling Protocol for 1,3-Dichloropropene, Methyl Bromide and Methyl Iodide Ambient Air Monitoring (Adler 2011)
Examples of DPR’s recommendations for an application-site study and ARB’s protocol:
Use Information and Air Monitoring Recommendation for Chlorthal-Dimethyl (Mullane 2010)
Sampling Protocol for Chlorthal-Dimethyl (Dacthal) Application Study (Aston 2011)
Modeling procedures to estimate fumigant air concentrations for exposure assessment:
Development of Sub-chronic Air Concentration Estimates Associated with a Single Fumigant Application (Barry 2008a)
Screening Level Air Concentration Estimates for Worker Health and Safety Exposure Analysis (Barry 2008b)
Example Risk Assessments
Chloropicrin
Risk Characterization Document (RCD) (DPR 2012)
RCD – Exposure Assessment Document (Beauvais 2012)
RCD – OEHHA comments on 2011 draft RCD/EAD and DPR responses (OEHHA 2012)
Chloropicrin as a Toxic Air Contaminant (TAC) – Executive Summary (DPR 2010a)
TAC – Part A (Exposure Assessment) (DPR 2010b)
TAC – Part B (Human Health Risk Assessment) (DPR 2010c)
TAC – OEHHA Findings (Fan and Marty 2009)
TAC – Scientific Review Panel Findings (SRP 2010)
TAC – Decision by DPR Director (Warmerdam 2010)
Methyl Iodide
Risk Characterization Document (2010) Volume I – Health Risk Assessment (DPR 2010d)
Appendices to Volume I (DPR 2010e)
Volume II – Exposure Assessment (DPR 2010f)
Volume III – Environmental Fate (DPR 2010g)
Volume IV (Part 1) – Responses to External Peer Review Panel (DPR 2010h)
Volume IV (Part 2) – Responses to Public Comments (DPR 2010i)
Carbaryl
Dietary Risk Characterization Document (DPR 2010j)
EPA Guidance Documents
DPR also noted that it uses the following EPA guidance documents. The committee did not review these documents.
Guidelines for Mutagenicity Risk Assessment (EPA 1986)
Guidelines for Developmental Toxicity Risk Assessment (EPA 1991)
Guidelines for Reproductive Toxicity Risk Assessment (EPA 1996)
Guidelines for Neurotoxicity Risk Assessment (EPA 1998)
Review of the Reference Dose and Reference Concentration Processes (EPA 2002)
Guidelines for Carcinogen Risk Assessment (EPA 2005)
REFERENCES
Adler, N. 2011. Sampling Protocol for 1,3-Dichloropropene, Methyl Bromide and Methyl Iodide Ambient Air Monitoring. Air Resource Board, California Environmental Protection Agency. November 11, 2011 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/tacpdfs/2011_ambient_protocol_final.pdf [accessed October 9, 2014].
Andrews, C. 2001. Worker Health and Safety Branch Policy on the Estimation of Short-term, Intermediate-term, Annual, and Lifetime Exposures. HSM-01014. Memorandum to Gary Patterson, Chief, Medical Toxicology Branch, from Chuck Andrews, Chief, Worker Health and Safety Branch, Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. October 1, 2001 [online]. Available: http://www.cdpr.ca.gov/docs/whs/memo/hsm01014.pdf [accessed October 9, 2014].
Andrews, C., and G. Patterson. 2000. Interim Guidance for Selecting Default Inhalation Rates for Children and Adults. HSM-00010. Memorandum to Worker Health and Safety Branch Staff, and Medical Toxicology Branch Staff, from Chuck Andrews, Chief, Worker Health and Safety Branch, and Gary Patterson, Chief, Medical Toxicology Branch, Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. December 1, 2000 [online]. Available: http://www.cdpr.ca.gov/docs/whs/memo/hsm00010.pdf [accessed October 9, 2014].
Aston, S. 2011. Sampling Protocol for Chlorthal-Dimethyl (Dacthal) Application Study. Air Resource Board, California Environmental Protection Agency. March 22, 2011 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/tacpdfs/chlorthal_dimethyl/chlorthal_dimethyl_2011.pdf [accessed October 9, 2014].
Barry, T. 2008a. Development of Sub-chronic Air Concentration Estimates Associated with a Single Fumigant Application. Memorandum to Randy Segawa, Environmental Program Manager, from Terrell Barry, Research Scientist, Environmental Monitoring Branch, Department of Pesticide Regulation. September 5, 2008 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/ehapreps/analysis_memos/2077_1_Segawa.pdf [accessed October 9, 2014].
Barry, T. 2008b. Screening Level Air Concentration Estimates for Worker Health and Safety Exposure Analysis. Memorandum to Randy Segawa, Environmental Program Manager, from Terrell Barry, Research Scientist, Environmental Monitoring Branch, Department of Pesticide Regulation. August 21, 2008 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/ehapreps/analysis_memos/2071_segawa.pdf [accessed October 9, 2014].
Beauvais, S. 2012. Estimation of Exposure of Persons in California to Pesticide Products That Contain Chloropicrin. HS-1880. Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. January 23, 2012 [online]. Available: http://www.cdpr.ca.gov/docs/risk/rcd/exposure_2012.pdf [accessed October 9, 2014].
Beauvais, S., S. Powell, and W. Zhao. 2007. Surrogate Handler Exposure Estimates for Use in Assessments by the California Department of Pesticide Regulation. HS-1826. Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. September 2007 [online]. Available: http://www.cdpr.ca.gov/docs/whs/pdf/hs1826.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2000. Guidance for Evaluating Genetic Toxicology Studies. Draft, August 2, 2000.
DPR (Department of Pesticide Regulation). 2004a. Process for Human Health Risk Assessment Prioritization and Initiation. Department of Pesticide Regulation, California Environmental Protection Agency. July 1, 2004 [online]. Available: http://www.cdpr.ca.gov/docs/risk/raprocess.pdf [accessed February 12, 2014].
DPR (Department of Pesticide Regulation). 2004b. Guidance for Benchmark Dose (BMD) Approach – Continuous Data. DPR MT-2. Department of Pesticide Regulation, California Environmental Protection Agency [online]. Available: http://www.cdpr.ca.gov/docs/risk/bmdcont.pdf [October 9, 2014].
DPR (Department of Pesticide Regulation). 2004c. Guidance for Benchmark Dose (BMD) Approach – Quantal Data. DPR MT-1. Department of Pesticide Regulation, California Environmental Protection Agency [online]. Available: http://www.cdpr.ca.gov/docs/risk/bmdquant.pdf [October 9, 2014].
DPR (Department of Pesticide Regulation). 2007. Final Notice on Active Ingredients Prioritized for Risk Assessment Initiation. Department of Pesticide Regulation, California Environmental Protection Agency. September 17, 2007 [online]. Available: http://www.cdpr.ca.gov/docs/risk/final_notice.pdf [accessed February 12, 2014].
DPR (Department of Pesticide Regulation). 2009. Guidance for Dietary Exposure Assessment. DPR MT-3 Version IV. Department of Pesticide Regulation, California Environmental Protection Agency. March 2009 [online]. Available: http://www.cdpr.ca.gov/docs/risk/dietary_updated.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010a. Evaluation of Chloropicrin as a Toxic Air Contaminant - Executive Summary. Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/exec_sum_0210.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010b. Evaluation of Chloropicrin as a Toxic Air Contaminant: Part A. Environmental Fate Review and Exposure Assessment. Department of Pesticide Regulation, California Environmental Protection Agency. January 2010 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/part_a_hs1846_0210.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010c. Evaluation of Chloropicrin as a Toxic Air Contaminant: Part B. Human Health Assessment. Department of Pesticide Regulation, California Environmental Protection Agency. February 4, 2010 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/part_b_0210.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010d. Methyl Iodide (Iodomethane): Risk Characterization Document for Inhalation Exposure, Volume I. Health Risk Assessment. Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/mei/mei_vol1_hra_final.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010e. Methyl Iodide (Iodomethane): Risk Characterization Document for Inhalation Exposure, Appendices to Volume I. (Health Risk Assessment). Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/mei/appendices_a-cfinal.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010f. Methyl Iodide (Iodomethane): Risk Characterization Document for Inhalation Exposure, Volume II. Exposure Assessment. Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/mei/mei_vol2_ea_final.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010g. Methyl Iodide (Iodomethane): Risk Characterization Document for Inhalation Exposure, Volume III. Environmental Fate. Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/mei/mei_vol3_ef_final.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010h. Methyl Iodide (Iodomethane): Risk Characterization Document for Inhalation Exposure, Volume IV-Part 1. Response to Scientific Review Committee Comments. Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/mei/mei_vol4_panel.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010i. Methyl Iodide (Iodomethane): Risk Characterization Document for Inhalation Exposure, Volume IV-Part 2. Response to Public Comments. Department of Pesticide Regulation, California Environmental Protection Agency. February 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/mei/mei_vol4_public.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2010j. Carbaryl (1-naphthyl methylcarbamate): Dietary Risk Characterization Document. Department of Pesticide Regulation, California Environmental Protection Agency. May 13, 2010 [online]. Available: http://www.cdpr.ca.gov/docs/risk/rcd/carbaryl.pdf [accessed October 9, 2014].
DPR (Department of Pesticide Regulation). 2011a. Prioritization and Status of Active Ingredients for Risk Characterization: Report No. 52. Department of Pesticide Regulation, California Environmental Protection Agency. July 15, 2011 [online]. Available: http://www.cdpr.ca.gov/docs/dept/prec/2011/prec_letter_report_52_20110916.pdf [accessed February 12, 2014].
DPR (Department of Pesticide Regulation). 2011b. A Guide to Pesticide Regulation in California. California Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA [online]. Available: http://www.cdpr.ca.gov/docs/pressrls/dprguide/dprguide.pdf [accessed October 6, 2014].
DPR (Department of Pesticide Regulation). 2011c. DPR Risk Assessment Guidance. September 22, 2011.
DPR (Department of Pesticide Regulation). 2012. Chloropicrin: Risk Characterization Document. Department of Pesticide Regulation California Environmental Protection Agency. November 14, 2012 [online]. Available:http://www.cdpr.ca.gov/docs/risk/rcd/chloropicrinrisk_2012.pdf [accessed October 9, 2014].
Edmiston, S., S. Powell, J. Spencer, and C. Curtis, 2002. Guidance for Determination of Dislodgeable Foliar Residue. HS-1600. Health and Safety Report, Revision No. 1. Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. February 20, 2002 [online]. Available: http://www.cdpr.ca.gov/docs/whs/pdf/hs1600.pdf [accessed October 9, 2014].
EPA (US Environmental Protection Agency). 1986. Guidelines for Mutagenicity Risk Assessment. EPA/630/R-98/003. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC. September 1986 [online]. Available: http://www.epa.gov/raf/publications/pdfs/MUTAGEN2.PDF [accessed October 10, 2014].
EPA (US Environmental Protection Agency). 1991. Guidelines for Developmental Toxicity Risk Assessment. EPA/600/FR-91/001. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC. December 1991 [online]. Available: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=23162 [accessed October 10, 2014].
EPA (US Environmental Protection Agency). 1996. Guidelines for Reproductive Toxicity Risk Assessment. EPA/630/R-96/009. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC. October 1996 [online]. Available: http://www.epa.gov/raf/publications/pdfs/REPRO51.PDF [accessed October 10, 2014].
EPA (US Environmental Protection Agency). 1998. Guidelines for Neurotoxicity Risk Assessment. EPA/630/R-95/00F. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC. April 1998 [online]. Available: http://www.epa.gov/raf/publications/pdfs/NEUROTOX.PDF [accessed October 10, 2014].
EPA (US Environmental Protection Agency). 2002. Review of the Reference Dose and Reference Concentration Processes. EPA/630/P-02/002F. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC [online]. Available: http://www.epa.gov/raf/publications/pdfs/rfd-final.pdf [accessed October 10, 2014].
EPA (US Environmental Protection Agency). 2005. Guidelines for Cancinogen Risk Assessment. EPA/630/P-03/001F. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC. March 2005 [online]. Available: http://www.epa.gov/raf/publications/pdfs/CANCER_GUIDELINES_FINAL_3-25-05.PDF [accessed October 10, 2014].
Fan, A.M., and M. Marty. 2009. Findings on the Health Effects on the Active Ingredient Chloropicrin. Memorandum to Gary T. Patterson, Chief, Medical Toxicology Branch, and Susan Edmiston, Chief, Worker Health and Safety Branch, Department of Pesticide Regulation, Sacramento, CA, from Anna M. Fan, Chief, Pesticide and Environmental Toxicology Branch, and Melanie Marty, Air Toxicology and Epidemiology Branch, Office of Environmental Health Hazard Assessment, Oakland, CA. November 24, 2009 [online]. Available: http://oehha.ca.gov/pesticides/peer/pdf/Chloropicrin_2009_Findings.pdf [accessed October 9, 2014].
Frank, J.P. 2009a. Method for Calculating Short-Term Exposure Estimates. HSM-09004. Memorandum to Worker Health and Safety Branch Staff, from Joseph P. Frank, Senior Toxicologist, Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. February 13, 2009 [online]. Available: http://www.cdpr.ca.gov/docs/whs/memo/hsm09004.pdf [accessed February 3, 2014].
Frank, J.P. 2009b. Exposure Assessment Policy and Procedure – Default Transfer Coefficients. HSM 09005. Memorandum to all Worker Health and Safety Branch Staff, from Joseph P. Frank, Senior Toxicologist, Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA. February 17, 2009 [online]. Available: http://www.cdpr.ca.gov/docs/whs/memo/hsm09005.pdf [accessed October 9, 2014].
Mullane, J. 2010. Use Information and Air Monitoring Recommendation for Chlorthal-Dimethyl. California Department of Pesticide Regulation. October 2010 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/recomm/chlorthal_dimethyl_recom2011.pdf [accessed October 9, 2014].
OEHHA (Office of Environmental Health Hazards Assessment). 2012. Comments on the 2011 Draft Risk Characterization Document for Chloropicrin [online]. Available: http://www.cdpr.ca.gov/docs/risk/rcd/oehha_comments.pdf [accessed October 9, 2014].
Oros, D.R., and R. Neal. 2010. Use Information and Air Monitoring Recommendations for 1,3-Dichloro-propene, Methyl Bromide, Chloropicrin, and Methyl Iodide. California Department of Pesticide Regulation. July 2010 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/recomm/1,3-d_mb_recomm10.pdf [accessed October 9, 2014].
Schreider, J. 2014. Final Recommendations Regarding the List of Active Ingredients Prioritized for Risk Assessment Initiation. Memorandum to Marylou Verder-Carlos, Assistant Director, from Jay Schreider, Senior Toxicologist, Medical Toxicology Branch, Department of Pesticide Regulation, California Environmental Protection Agency. February 18, 2014 [online]. Available: http://www.cdpr.ca.gov/docs/risk/priot_wkgrp.pdf [accessed April 24, 2014].
SRP (Scientific Review Panel). 2010. Findings of the Scientific Review Panel on “Evaluation of Chloropicrin as a Toxic Air Contaminant” as Adopted at the Panel’s February 24, 2010 Public Meeting [online]. Available: http://www.arb.ca.gov/srp/findings/2-24-10.pdf [accessed October 9, 2014].
Thongsinthusak, T., J. H. Ross, and D. Meinders. 1993. Guidance for the Preparation of Human Pesticide Exposure Assessment Documents. HS-1612. Department of Pesticide Regulation, California Environmental Protection Agency, Sacramento, CA [online]. Available: http://www.cdpr.ca.gov/docs/whs/pdf/hs1612.pdf [accessed October 9, 2014].
Warmerdam, M.A. 2010. Director’s Proposed Decision Concerning Chloropicrin as a Toxic Air Contaminant. Memorandum to Christopher Reardon, Chief Deputy Director, from Mary-Ann Warmerdam, Director, Department of Pesticide Regulation. April 15, 2010 [online]. Available: http://www.cdpr.ca.gov/docs/emon/pubs/tac/tacpdfs/chloropicrin/final_decision041510.pdf [accessed October 9, 2014].
