EPA’s Regulatory Policies:Clean Water Act & Safe Drinking
Water ActOctavia Conerly, MSPH
Office of WaterU.S. Environmental Protection Agency
Washington, DC
Working Group on Pesticides in the Chesapeake WaterwaysMay 14, 2007
…to protect human health and the environment
Overview• Office of Water organization
• EPA regulatory framework
• Office of Water regulatory framework– Clean Water Act– Safe Drinking Water Act
…to protect human health and the environment
Office of the Assistant Administrator
Assistant Administrator,Benjamin Grumbles
Management & OperationsStaff
Water Policy Staff
Resources ManagementStaff
Communications Team
American Indian Environmental Office
Office of Ground Water & Drinking Water
Water Security Division
Drinking Water Protection Division
Office of Science & TechnologyDirector, Ephraim S. King
Office of Wastewater Management
Office of Wetlands, Oceans & Watersheds
Engineering & Analysis Division
Director, Mary T. Smith
Municipal Support DivisionAssessment & Watershed
Protection Division
Health & Ecological Criteria Division
Director, Edward Ohanian
Standards & Health Protection Division
Director, Denise Keehner
Water Permits DivisionOceans & Coastal
Protection Division
Wetlands Division
Senior Policy Advisor
Standards & Risk Management Division
Office of WaterOffice of Water
EPA Regulatory Framework• Clean Air Act (CAA)• National Environmental Policy Act (NEPA)• Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)• Food Quality Protection Act (FQPA)• Toxic Substances Control Act (TSCA)• Resource Conservation and Recovery Act (RCRA)• Clean Water Act (CWA)Clean Water Act (CWA)• Safe Drinking Water Act (SDWA)Safe Drinking Water Act (SDWA)• Others…
Example
• Reports of intersex fish
• What is EPA doing?
…to protect human health and the environment
Compounds of Emerging Concern in Water*
Pesticides
Pharmaceuticals and
Personal Care Products
Endocrine DisruptingCompounds
PFOA
PBDEs
Prions
Nanomaterials
*Not an exhaustive list.
Legislative Authorities for Water
• Clean Water Act (1977)– Sets water quality criteria and guidelines and technology-based standards for ambient water– Objective is to restore and maintain the
chemical, physical and biological integrity of the Nation’s waters
• Safe Drinking Water Act (1974), amended 1986, 1996
– Requires EPA to set maximum levels for contaminants in water delivered to users of public water systems.
SDWASDWA
Ground Ground WaterWater
Ground WaterGround Waterused as used as
Drinking WaterDrinking Water
Surface Water
Used as Drinking
Water
Surface Water Surface Water Used for Used for
Industrial Uses, Industrial Uses, Recreation, Recreation,
Wildlife Habitat, Wildlife Habitat, and Fishingand Fishing
CWACWA
Legislative Authorities for WaterLegislative Authorities for Water
Wastewater Wastewater DischargesDischarges
Water SystemsWater SystemsWastewater Wastewater
Treatment PlantsTreatment Plants
OW Statutory Framework (Cont’d)
A. Safe Drinking Water Act– Contaminant Candidate List (CCL)
• List published every 5 years• Prioritizes contaminants for possible
regulation and/or future research• Regulatory determinations for
5 contaminants from list every 5 years
– Six Year Review• National Primary Drinking Water Standards
are reviewed every 6 years• Any revisions to standards are based on new data
Does the contaminant adversely affect public health?
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?
Regulate with NPDWR
Regulation under SDWA
Research Assessment ManagementResearch Assessment ManagementEPA Scientific Research/Data Collection
Risk Assessment
RiskManage-
mentDecisions
Dose-ResponseAssessment
• Animal Toxicology• Clinical Studies• Epidemiology• Cell/Tissue Experiments• Computational Methods• Monitoring/ Surveillance
ResearchNeeds
HazardIdentification
ExposureAssessment
RiskCharacteri-
zation
TreatmentTechnology
Costs/Benefits
Risk Management
CollaborationCollaboration
External Inputinto Research/ Assessment
• Other Federal Agencies• States/Local• Academia• Industry• Public Interest/Environmental Groups
OW Statutory Framework (Cont’d)
Safe Drinking Water Act cont…– Health Advisories
• Guidance values based on
non-cancer health effects for
different durations of exposure
• Provide technical guidance for
Regions, States and other public
health officials
– Unregulated Contaminant Monitoring Rule• Monitors for unregulated contaminants
OW Statutory Framework (Cont’d)
B. Clean Water Act• Water Quality Standards
– States designate use for water – Water Quality Criteria (conditions supporting designated
uses); EPA publishes national criteria (risk assessments)• Chemical criteria
• Biological Criteria (apply to aquatic life designated uses)
– States set standards; EPA approves– Antidegradation (keeping good-quality waters in good
condition)
OW Statutory Framework (Cont’d)• Effluent Guidelines for the regulation of point sources
– Pharmaceutical Manufacturing Industry (1998)– Aquaculture Rule for large CAAP facilities (2004)
• Combined Animal Feeding Operations Rule– Rule deals with nutrients – but results in less overall
contamination of surface waters– Discharge permits required for “large” CAFOs
• Fish Advisory program• Guidance, voluntary programs
Effluent Guidelines• Pharmaceutical Manufacturing Industry (1998)
– Includes • Mfg of pharmaceutically active ingredients as defined
by FDA• Only cosmetics containing pharmaceutically active
ingredients are included – Regulation is based on performance of treatment / control
technologies (rather than risk)– Limits on Biochemical Oxygen Demand, Chemical
Oxygen Demand, Volatile Organic Contaminants, Total Suspended Solids, pH
Effluent Guidelines• Aquaculture (June 2004)
– Covers large facilities • Flow through, re-circulating
or net pens• Directly discharge waste
water• Produce 100,000 lbs fish/year
– Requirements include • Best Management Plans• Prevent discharge of spilled drugs and pesticides;
minimize discharge of feed• Limit discharge of wastewater from harvest or transport
Various Stewardship Efforts
• Federal efforts– “Do not flush” guidelines (2/20/07)
• EPA/ONDCP/DHHS
– Drug Take-Back Pilot Studies• EPA/OCHP
– Universal Waste Rule• EPA/OSW
…to protect human health and the environment
White House OSTP Toxics and Risks Subcommittee (Interagency Workgroups)
• Pharmaceuticals in the Environment (PiE) Workgroup – Participating Agencies
• EPA/FDA/USGS (Co-leads), CDC, NIEHS, NOAA, USDA, FWS
– Goals• Develop 2 strategies delineating data gaps/priorities/areas of collaboration
– Research strategy for human and veterinary pharmaceuticals in the environment (12/2007)
– Research strategy for antibiotics in the environment; focusing on the question of antibiotic resistance (12/2008)
• Endocrine Disruption in the Environment Workgroup– Participating Agencies
• EPA (Lead), NIEHS, DOI, NOAA, FDA, CDC, NSF, ATSDR, NCI, DOE, DOD, USDA, The Smithsonian Institution
– Goals• Develop a planning framework for Federal research related to human health
and ecological effects of endocrine disrupting compounds• Identify research gaps and develop a coordinated plan to address priority
research needs
EPA Research and Studies
• Office of Research and Development– NCER: STAR Grants Program– Research targeted at development of new chemical
analysis methods, improved waste treatment, aquatic effects and new approaches for prioritizing chemicals for monitoring
– Endocrine Disruptors Research Program
EPA Research and Studies cont…• Office of Water
– National Pilot Study of PPCPs in Fish Tissue• Principle Goals
– The purpose of the study is to investigate the occurrence of PPCP chemicals in fish tissue from effluent-dominated streams at five locations in various parts of the U.S.
• Study Design– Collecting fish samples from 5 effluent dominated streams
from various locations across the country– Collecting 18 to 24 fish in the vicinity of wastewater treatment plant discharges– Validated analytical methods available for 37 PPCP compounds (24 pharmaceuticals, 13 personal care products)
EPA Research and Studies cont…• Office of Water cont…
– Publicly Owned Treatment Works Study• Principal Goals
– Establish baseline for POTW raw wastewater characteristics and characterize performance of an expanded list of pollutants for various treatment technologies
– Priority (toxic), conventional and non-conventional pollutants
• Study Design– Sample 9 POTWs with secondary treatment or better – Sample influent and effluent– Collect available information and identify data gaps – Identify emerging pollutants of interest– Develop/refine analytical methods
EPA Research and Studies cont.• Office of Water cont…
– National Targeted Biosolids Survey• Purpose
– Gather information to update assessment of risks from pollutants in sewage sludge
• Study Design– Random selection of 75 POTWs– Sampling for presence and concentration of metals, 9 chemicals, and up to 59 PPCPs and flame retardants– Currently developing methods for identification and
quantitation of three classes of PPCPs and estrogen-related compounds that persist in biosolids.
Opportunities for Collaboration
• Data sharing with various agencies (e.g.-USGS, CDC, FDA, USDA)– Occurrence and health effects data
– To develop water quality standards/criteria– To develop drinking water regulations – To assess increasing antibiotic resistance– To develop effluent guidelines
• Technology sharing– Methods development– Treatment
• External input into EPA assessments