regulatory perspective: epa/ow’s strategy for contaminants of emerging concern

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Regulatory Perspective: EPA/OW’s Strategy for Contaminants of Emerging Concern. Diana M. Eignor Health and Ecological Criteria Division Office of Water U.S. Environmental Protection Agency Washington, DC 2008 Watershed Science and Technical Conference West Point, N.Y. September 2008. - PowerPoint PPT Presentation


  • Regulatory Perspective: EPA/OWs Strategy for Contaminants of Emerging Concern

    Diana M. EignorHealth and Ecological Criteria DivisionOffice of WaterU.S. Environmental Protection AgencyWashington, DC

    2008 Watershed Science and Technical ConferenceWest Point, N.Y.September 2008

    to protect human health and the environment

  • OverviewContaminants of emerging concern

    Reason for concern

    EPAs four-pronged strategy

    Unique challenges ahead

    to protect human health and the environment

  • PFOAPBDEsPrionsNanomaterials*Not an exhaustive list.

  • Pharmaceuticals of ConcernPharmaceuticalsPrescription & over-the-counter therapeutic drugsVeterinary medicine

    Detected in Water Steroids/HormonesAntibioticsAntidepressantsAnalgesics AntimicrobialsStatinsAntiepilepticsAntineoplastics

  • Is there Concern?Some studies have documented occurrence in low levels in source and finished drinking water. Pharmaceuticals are designed to be biologically active at low levels. An increase in the use of pharmaceuticals is anticipated as the US population grows older.Associated risks to humans and the environment are uncertain. However, demonstrated presence has generated Congressional and public concern.

  • EPAs Four-Pronged Strategy

    1) Strengthening our Scientific KnowledgeIdentifying potential contaminants of concern in surface water and drinking waterIdentifying information gaps and targeting collection of needed effects, dose, concentration, methods, and occurrence information2) Improving Public Understanding and Risk CommunicationProviding information to help the public understand the issues and inform policy choices3) Building Partnerships for StewardshipWorking to prevent pharmaceuticals from entering water4) Using Regulatory ToolsUsing EPAs regulatory tools when sufficient information exists

  • 1. Strengthening our Scientific Knowledge: Methods DevelopmentAnalytical methods are lacking for most contaminants of emerging concernOST developed and released methods for analysis of ~100 pharmaceuticals, personal care products, steroids, and hormones in water, soil, sediment, and biosolids.Methods 1694, 1698 and 1699 at on drinking water analytical methods

  • Strengthening our Scientific Knowledge: Occurrence EPA is conducting studies to understand the potential occurrence of pharmaceuticals in wastewater effluent, biosolids, and fish tissue:Publicly Owned Treatment Works (POTW) Study (12/09)Pilot Study of PPCPs in Fish Tissue (10/08)Expanded Fish Tissue Study (12/10)National Targeted Sewage Sludge Survey (9/08)Grants (ongoing)

  • 2. Improving Public Understanding and Risk CommunicationGeneral EPA PPCP website -- focus on research:

    Launched new website (August 6, 2008) -- focused on PPCPs in water:

  • 3. Building Partnerships for StewardshipONDCP/EPA/HHS issued drug disposal guidelines (2/07)Pharmaceuticals in the Environment (PiE) and EDC in the Environment Workgroups to coordinate federal research effortsOther stewardship efforts supported by EPA include:Grant to ARCHS in St. Louis ($150K) for take-back of non-controlled, unused medicines at pharmaciesGrant to University of Maine ($150K) for mail-back of unused medicines w/law enforcement involvementGreat Lakes Earth Week Challenge--grants funding 24 collection events (medicines, e-waste or both) -- 1M pill goal far exceededGrant to Albany Medical Center in NY (>$100K) to identify ways to better manage pharmaceutical waste and educate health professionalsCalifornia Statewide No Drugs Down the Drain campaign planned for October 4 11, 2008 supported by EPA Region 9World Health Organization (WHO) Task Force on PPCPs in Drinking Water plan to address various human health issues

  • Various Stewardship EffortsFederal effortsDo not flush guidelines (2/07)EPA/ONDCP/DHHSDrug Take-Back Pilot StudiesEPA/OAUniversal Waste RuleEPA/OSW

  • Building Partnerships (Cont.)Letters to all States (state environmental & public health dept. directors)Stakeholder listening sessions on PPCPs in waterEnvironmental/NGOs (5/7/08)Drinking water/Wastewater Utilities (5/13/08)State Associations (5/14/08)Agricultural Associations (6/4/08)Major Stakeholders Recommendations/Concerns Human Health Effects need better understanding of effectsRisk Communication need consistent, clear, concise messageTake Back Programs need more funding/supportDrug Disposal Policy need to revisit and clarifyMonitoring programs need funding

  • 4. Using Regulatory ToolsIf sufficient information exists, we will take actionHealth Services StudyInformation Collection Request (ICR) releasedWhite Paper addressing Developing Aquatic Life Criteria for CECsAmbient Water Quality Criteria for Human Health and Aquatic LifeContaminant Candidate List (CCL3)Unregulated Contaminant Monitoring Rule (UCMR)Drinking Water Health Advisories Six-Year Review

  • EPA Statutory FrameworkSafe Drinking Water Act Contaminant Candidate List (CCL)Six Year Review Health AdvisoriesUnregulated Contaminant Monitoring Rule (UCMR)Clean Water Act Human Health and Aquatic Life Criteria Water Quality Standards Effluent Guidelines for point sourcesConcentrated Animal Feeding Operations (CAFOs) Food Quality Protection ActEndocrine Disruptors Screening Program (EDSP)Resource Conservation and Recovery Act Universal Waste RuleToxics and Substances Control ActPremanufacture Notices (PMNs), High Production Volume (HPV) chemicalsFederal Insecticide, Fungicide and Rodenticide ActPesticide Registration and Re-registration

  • Unique Challenges AheadNature of available data (adverse effect vs beneficial effect)Limited access to toxicological data for human pharmaceuticalsAbsence of chronic, low-dose exposure data Lack of drug interactions (mixtures) dataApplication of available risk assessment methodsIntersex fish human health connectionAvailable analytical and removal methods

  • Next Steps

    Collaborate with Federal/non-Federal, and international partners in targeting timely research, monitoring, testing and risk analyses efforts to fill data gaps to support criteria development and regulatory actions

  • Contact Information



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