EPA/Office of Water’s
Strategy for
Contaminants of Emerging Concern
Octavia Conerly
Health and Ecological Criteria Division
Office of Water
U.S. Environmental Protection Agency
Washington, DC
…to protect human health and the environment
Overview
• Contaminants of emerging concern
• Reason for concern
• EPA’s four-pronged strategy
• Unique challenges ahead
…to protect human health and the environment
Contaminants of Emerging Concern in Water*
Pharmaceuticals
and Personal Care
Products
PFOA
Nanomaterials
Pesticides
Prions
Endocrine
Disrupting
Compounds
PBDEs
*Not an exhaustive list.
Pharmaceuticals of Concern
• Pharmaceuticals
• Prescription & overthe-counter
therapeutic drugs
• Veterinary medicine
• Detected in Water
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Steroids/Hormones
Antibiotics
Antidepressants
Analgesics
Antimicrobials
Statins
Antiepileptics
Antineoplastics
Is there concern for Human Health?
• 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 gets older.
• Associated risks to humans and the environment are
uncertain. However, demonstrated presence has
generated Congressional and public concern.
EPA’s 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 EPA’s regulatory tools when sufficient information exists
1. Strengthening our Scientific
Knowledge: Methods Development
• Analytical methods are lacking for most emerging
contaminants
• 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/waterscience/methods/method/other.html
• Working 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 Communication
• General EPA PPCP website -- focus on research:
www.epa.gov/ppcp/
• OW to improve website with additional information
on PPCPs in water efforts
3. Building Partnerships for Stewardship
• ONDCP/EPA/HHS issued drug disposal guidelines (2/07)
• Pharmaceuticals in the Environment (PiE) Workgroup 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 (>$100K) 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 Region 9
Various Stewardship Efforts
• Federal efforts
– “Do not flush” guidelines (2/07)
• EPA/ONDCP/DHHS
– Drug Take-Back Pilot Studies
• EPA/OCHPEE
– Universal Waste Rule
• EPA/OSW
Building Partnerships (Cont.)
• Letters to all States (state environmental & public health dept.
directors)
• Stakeholder listening sessions on PPCPs in water
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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
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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
4. Using Regulatory Tools
• If sufficient information exists, we will take action
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Health Services Study
Contaminant Candidate List (CCL3)
Unregulated Contaminant Monitoring Rule (UCMR)
Ambient Water Quality Criteria for Human Health and
Aquatic Life
– Drinking Water Health Advisories
– National Primary Drinking Water Regulations
– Six-Year Review
EPA Statutory Framework
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Safe Drinking Water Act
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Contaminant Candidate List (CCL)
Six Year Review
Health Advisories
Unregulated Contaminant Monitoring Rule (UCMR)
Clean Water Act
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Human Health and Aquatic Life Criteria
Water Quality Standards
Effluent Guidelines for point sources
Concentrated Animal Feeding Operations (CAFOs)
Food Quality Protection Act
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Endocrine Disruptors Screening Program (EDSP)
Resource Conservation and Recovery Act
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Universal Waste Rule
Toxics and Substances Control Act
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Premanufacture Notices (PMNs), High Production Volume (HPV) chemicals
Federal Insecticide, Fungicide and Rodenticide Act
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Pesticide Registration and Re-registration
Regulatory Determination
Does the contaminant adversely affect
public health?
Regulate with
NPDWR
Is the contaminant known or likely to occur in
PWSs with a frequency and at levels posing a
threat to public health?
Will regulation of the contaminant present a
meaningful opportunity for health risk reduction?
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
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