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

Next StepsCollaborate…Collaborate…Collaborate

• Collaborate with Federal/non-Federal partners in targeting research and testing to fill data gaps to support criteria development and regulatory actions

• Broaden collaboration with USGS on methods development and monitoring