Farmworker and Conservation Comments on Chlorpyrifos Revised Human Health Risk Assessment Earthjustice Farmworker Justice Natural Resources Defense Council Pesticide Action Network California Rural Legal Assistance Foundation Farm Labor Organizing Committee Pineros y Campesinos Unidos del Noroeste United Farm Workers April 30, 2015 EPA-HQ-OPP-2008-0850 TABLE OF CONTENTS INTRODUCTION .......................................................................................................................... 1 EXECUTIVE SUMMARY ............................................................................................................ 1 I. LEGAL AND REGULATORY BACKGROUND .............................................................7 A. The Overlapping Statutes Regulating Pesticide Use ...............................................7 B. EPA’s 2001 and 2006 Chlorpyrifos Determinations Failed to Address Serious Health Impacts to Children and Other Bystanders. ....................................9 C. Petitions and Litigation to Obtain EPA Action on Evidence of Chlorpyrifos Health Risks. ..........................................................................................................11 II. THE RHHRA FINDS THAT CHLORPYRIFOS CAUSES NEURODEVELOPMENTAL DAMAGE TO CHILDREN EXPOSED IN UTERO AND RETAINS A TENFOLD FQPA SAFETY FACTOR, BUT FAILED TO CONSIDER WHETHER A LARGER SAFETY FACTOR IS WARRANTED DUE TO THE DEMONSTRATED PRENATAL TOXICITY FROM EXPOSURES LOWER THAN EPA’S REGULATORY ENDPOINT. ...................................................13 A. EPA Accurately Finds That The Extensive Scientific Record Establishes That Prenatal Chlorpyrifos Exposures Result In Neurodevelopmental Impairments. ..........................................................................................................14 B. EPA Accurately Finds That The Neurodevelopmental Effects Are The Most Sensitive Endpoint Related To Chlorpyrifos Toxicity. ..........................................16 C. EPA Appropriately Retains a 10X FQPA Safety Factor For Data Completeness Based on Critical Gaps in the Toxicity Database Related to Neurodevelopmental Effects in Children, But it Erroneously Failed to Consider Whether the Demonstrated Prenatal Toxicity Warrants a Larger FQPA Safety Factor Because of The Severity of the Adverse Effects And The Uncertainty as to the Exposure Levels at Which They Occur. .......................17 D. EPA Acted Arbitrarily And Contrary to its Own Findings and the Scientific Evidence by Continuing to Use 10% Cholinesterase Inhibition as The Limit in the RHHRA Even Though Neurodevelopmental Effects Occur at Lower Doses and Therefore are the Most Sensitive Endpoint. .........................................23 III. EPA CANNOT REDUCE THE TRADITIONAL SAFETY FACTORS BASED ON A DOW MODEL THAT IS DESIGNED TO PREDICT 10% CHOLINESTERASE INHIBITION......................................................................................................................28 A. The Dow Model is Tailored to 10% Cholinesterase Inhibition While EPA Has Found That the Human Health Endpoint of Greatest Concern is Early i Life Exposures Leading To Neurodevelopmental Effects, Which Occur at Lower Doses. .........................................................................................................30 B. The Dow Model has Serious Scientific Limitations, Lacks Proper Validation, and was met With Serious Criticisms by EPA’s SAP, Which Have Not Been Addressed Through a Subsequent Peer Review. ...................................................32 C. Dow’s Model Relies on Deliberate Human Dosing Studies That EPA’s Advisors Have Criticized on Scientific and Ethical Grounds, and EPA Has Failed to Subject to Thorough Review Under the Controlling Regulations. .........36 IV. EPA IS FAILING TO PROTECT CHILDREN AND OTHER BYSTANDERS FROM CHLORPYRIFOS. ................................................................................................42 A. Chlorpyrifos Causes Poisonings of Children and Other Bystanders Every Year. .......................................................................................................................43 B. EPA Fails to Account for all Drift Exposures and Affords Insufficient Protection From Inhalation Exposures...................................................................45 C. The Buffers Are Far Too Small to Prevent Harmful Pesticide Drift Exposure. ....46 D. EPA Fails To Account For Exposure To Dust.......................................................49 E. The RHHRA Erroneously Ignores Volatilization Exposures. ...............................50 V. THE RHHRA REVEALS UNACCEPTABLE RISKS TO WORKERS THAT MUST BE PREVENTED AND UNDERESTIMATES THE EXTENT OF THE RISKS THAT ARE UNACCEPTABLE. ..........................................................................58 A. EPA Must Cancel The Uses That Admittedly Expose Workers To Unacceptable Risks. ...............................................................................................58 B. EPA Cannot Lawfully Ignore Direct Spray Drift. .................................................60 C. EPA Underestimates Worker Risks By Making Unsupported Assumptions. .......67 D. EPA Overestimates the efficacy of Protective Clothing and Engineering Controls. .................................................................................................................71 VI. EPA MUST PREVENT HARMFUL DRINKING WATER CONTAMINATION. ........73 A. EPA appropriately finds that chlorpyrifos-oxon would be present in finished drinking water. .......................................................................................................74 VII. THE RHHRA FAILS TO ANALYZE AND PROTECT AGAINST ENVIRONMENTAL JUSTICE IMPACTS. .....................................................................76 A. Background ............................................................................................................76 ii CONCLUSION ............................................................................................................................. 82 APPENDICES 1. Chlorpyrifos-Only Incidents from California Pesticide Illness Surveillance Program. 2. NRDC, Map of Chlorpyrifos Usage by County with Demographics (2015). iii LIST OF EXHIBITS NO. TITLE 1. Dale Hattis et al., Chlorpyrifos Doses to Women of the Columbia University Cohort and Neurodevelopmental Impairment—A Bayesian-Inspired Uncertainty Analysis and Risk Projection Reflecting Inputs from Different Sources of Information (2015) 2. EPA, Exposure Factors Handbook (2011) 3. Dale Hattis, Chlorpyrifos Pharmacokinetics – Need and Opportunity for Calibration with Available Human Data from Known In Vivo Exposures (Feb. 16, 2011) (EPA-HQ- OPP-2010-0588-0024) 4. Soo-Jeong Lee et. al., Acute Pesticide Illnesses Associated with Off-Target Pesticide Drift from Agricultural Applications — 11 States, 119 Envtl. Health Persp. 1162 (2011). 5. Geoffrey M. Calvert et. al., Acute Pesticide Poisoning Among Agricultural Workers in the United States, 1998–2005, 51 Am. J. Indus. Med. 883 (2008) 6. Washington State Department of Health, Pesticide Data Report (June 2013), available at http://www.doh.wa.gov/Portals/1/Documents/Pubs/334-319.pdf 7. Katherine Mills and Susan Kegley, Pesticide Action Network North America, Air Monitoring for Chlorpyrifos in Lindsay, California (July 14, 2006) 8. Sean Gray et al., Environmental Working Group, Every Breath You Take: Airborne Pesticides in the San Joaquin Valley (Jan. 2001) 9. California Air Resources Board, Final Report for the 1996 Chlorpyrifos Monitoring in Tulare County (Apr. 13, 1998) 10. Asa Bradman et al., Determinants of Organophosphorus Pesticide Urinary Metabolite Levels in Young Children Living in an Agricultural Community, 8 Int. J. Envtl. Res. Public Health 1061 (2011) 11. Robert B. Gunier et al., Determinants of Agricultural Pesticide Concentrations in Carpet Dust, 119 Envtl. Health Persp. 970 (2011) 12. Margaret Reeves, Anne Katten, Martha Guzman, Fields of Poison: California Farmworkers and Pesticides (2002) 13. Bud Hover, Director, Washington State Dept. of Agriculture Pesticide Management Division, 2013 Annual Report to the Legislature (Feb. 2014, Revised March 2014) iv NO. TITLE 14. California Department of Pesticide Regulation Pesticide Illness Surveillance Program, Illness and Injuries Reported in California Associated with Pesticide Exposure Summarized by the Type of Activity and Type of Exposure (2012) 15. California Environmental Protection Agency Department of Pesticide Regulation, Summary of Results from the California Pesticide Illness Surveillance Program 2012, HS-1896 (Jan. 13, 2015) 16. Spray Drift Workgroup, Final Report to PPDC (Apr. 27, 2007) 17. Human Rights Watch, Tobacco’s Hidden Children (2014), available at http://www.hrw.org/sites/default/files/reports/us0514_UploadNew.pdf 18. William Kandel, USDA, A Profile of Hired Farmworkers, A 2008 Update (July 2008), available at http://www.ers.usda.gov/publications/err-economic-research- report/err60.aspx 19. Department of Labor, Report on Children in the Labor Force (2000), available at http://www.bls.gov/opub/rylf/pdf/chapter5.pdf 20. Quirina M. Vallejos et al., Migrant Farmworkers’ Housing Conditions Across an Agricultural Season in North Carolina, 54 Am. J. Indus. Med. 533 (2011) 21. Thomas A. Arcury et al., Migrant Farmworker Housing Regulation Violations in North Carolina, 55 Am. J. Indus. Med. 191 (2012), available at http://www.ncbi.nlm.nih.gov/pubmed/22237961 22. J. H. Raymer et al., Pesticide exposures to migrant