Regulatory Perspective: EPA/OW

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Regulatory Perspective EPA/OWs 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

to protect human health and the environment
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Overview

• Contaminants of emerging concern
• Reason for concern
• EPAs four-pronged strategy
• Unique challenges ahead

to protect human health and the environment
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PFOA
Prions
Nanomaterials
PBDEs
Not an exhaustive list.
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Pharmaceuticals of Concern

• Pharmaceuticals
• Prescription over-the-counter therapeutic drugs
• Veterinary medicine

• Detected in Water
• Steroids/Hormones
• Antibiotics
• Antidepressants
• Analgesics
• Antimicrobials
• Statins
• Antiepileptics
• Antineoplastics

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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.

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EPAs Four-Pronged Strategy

• 1) Strengthening our Scientific Knowledge
• Identifying potential contaminants of concern in
  surface water and drinking water
• Identifying information gaps and targeting
  collection of needed effects, dose,
  concentration, methods, and occurrence
  information
• 2) Improving Public Understanding and Risk
  Communication
• Providing information to help the public
  understand the issues and inform policy choices
• 3) Building Partnerships for Stewardship
• Working to prevent pharmaceuticals from entering
  water
• 4) Using Regulatory Tools
• Using EPAs regulatory tools when sufficient
  information exists

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1. Strengthening our Scientific Knowledge
Methods Development

• Analytical methods are lacking for most
  contaminants of emerging concern
• OST 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 www.epa.gov/watersc
  ience/methods/method/other.html
• Working on drinking water analytical methods

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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)

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2. Improving Public Understanding and Risk
Communication

• General EPA PPCP website -- focus on research
  www.epa.gov/ppcp/
• Launched new website (August 6, 2008) -- focused
  on PPCPs in water www.epa.gov/waterscience/ppcp/

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3. Building Partnerships for Stewardship

• ONDCP/EPA/HHS issued drug disposal guidelines
  (2/07)
• Pharmaceuticals in the Environment (PiE) and EDC
  in the Environment Workgroups to coordinate
  federal research efforts
• Other stewardship efforts supported by EPA
  include
• Grant to ARCHS in St. Louis (150K) for take-back
  of non-controlled, unused medicines at pharmacies
• Grant to University of Maine (150K) for
  mail-back of unused medicines w/law enforcement
  involvement
• Great Lakes Earth Week Challenge--grants funding
  24 collection events (medicines, e-waste or both)
  -- 1M pill goal far exceeded
• Grant to Albany Medical Center in NY (gt100K) to
  identify ways to better manage pharmaceutical
  waste and educate health professionals
• California Statewide No Drugs Down the Drain
  campaign planned for October 4 11, 2008
  supported by EPA Region 9
• World Health Organization (WHO) Task Force on
  PPCPs in Drinking Water plan to address various
  human health issues

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Various Stewardship Efforts

• Federal efforts
• Do not flush guidelines (2/07)
• EPA/ONDCP/DHHS
• Drug Take-Back Pilot Studies
• EPA/OA
• Universal Waste Rule
• EPA/OSW

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Building Partnerships (Cont.)

• Letters to all States (state environmental
  public health dept. directors)
• Stakeholder listening sessions on PPCPs in water
• Environmental/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 effects
• Risk Communication need consistent, clear,
  concise message
• Take Back Programs need more funding/support
• Drug Disposal Policy need to revisit and
  clarify
• Monitoring programs need funding

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4. Using Regulatory Tools

• If sufficient information exists, we will take
  action
• Health Services Study
• Information Collection Request (ICR) released
• White Paper addressing Developing Aquatic Life
  Criteria for CECs
• Ambient Water Quality Criteria for Human Health
  and Aquatic Life
• Contaminant Candidate List (CCL3)
• Unregulated Contaminant Monitoring Rule (UCMR)
• Drinking Water Health Advisories
• Six-Year Review

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EPA Statutory Framework

• Safe Drinking Water Act
• Contaminant Candidate List (CCL)
• Six Year Review
• Health Advisories
• Unregulated Contaminant Monitoring Rule (UCMR)
• Clean Water Act
• Human Health and Aquatic Life Criteria
• Water Quality Standards
• Effluent Guidelines for point sources
• Concentrated Animal Feeding Operations (CAFOs)
• Food Quality Protection Act
• Endocrine Disruptors Screening Program (EDSP)
• Resource Conservation and Recovery Act
• Universal Waste Rule
• Toxics and Substances Control Act
• Premanufacture Notices (PMNs), High Production
  Volume (HPV) chemicals
• Federal Insecticide, Fungicide and Rodenticide
  Act
• Pesticide Registration and Re-registration

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Unique Challenges Ahead

• Nature of available data (adverse effect vs
  beneficial effect)
• Limited access to toxicological data for human
  pharmaceuticals
• Absence of chronic, low-dose exposure data
• Lack of drug interactions (mixtures) data
• Application of available risk assessment methods
• Intersex fish human health connection
• Available analytical and removal methods

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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

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Contact Information

• Diana Eignor
• 202-566-1143
• eignor.diana_at_epa.gov
• www.epa.gov/waterscience/ppcp/