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EPA Regulatory Authority and EPA Regulatory Authority and PPCPsPPCPs

Octavia Conerly Octavia Conerly

Health and Ecological Criteria DivisionHealth and Ecological Criteria Division

Office of WaterOffice of Water

October 26, 2005October 26, 2005

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USEPA DisclaimerUSEPA Disclaimer

The contents of this presentation are the expressed The contents of this presentation are the expressed opinions of the author and do not necessarily opinions of the author and do not necessarily

reflect the opinions of the USEPA.reflect the opinions of the USEPA.

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Presentation OutlinePresentation Outline

• EPA’s Enabling LegislationEPA’s Enabling Legislation

• Office of Water’s Major Legislative AuthoritiesOffice of Water’s Major Legislative Authorities– Safe Drinking Water ActSafe Drinking Water Act

– Clean Water ActClean Water Act

• OW PPCP Related Work (What is EPA doing?)OW PPCP Related Work (What is EPA doing?)

• Opportunities for CollaborationOpportunities for Collaboration

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EPA’s Enabling LegislationEPA’s Enabling Legislation

• Is a very mixed bag of lawsIs a very mixed bag of laws

• Dictate how we do our business and what we Dictate how we do our business and what we are capable of doingare capable of doing

• Are not always consistent with one another Are not always consistent with one another

• Often require science-based decisionsOften require science-based decisions– e.g. SDWA 1996 requires use of best publicly e.g. SDWA 1996 requires use of best publicly

available, peer reviewed scienceavailable, peer reviewed science

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Legislative Authorities for WaterLegislative Authorities for Water

• Safe Drinking Water ActSafe Drinking Water Act (1974), amended 1986, (1974), amended 1986, 19961996– Requires EPA to set maximum levels for contaminants in Requires EPA to set maximum levels for contaminants in

water delivered to users of public water systems.water delivered to users of public water systems.

• Clean Water ActClean Water Act (1977) (1977)– Sets water quality criteria and guidelines and technology-Sets water quality criteria and guidelines and technology-

based standards for ambient watersbased standards for ambient waters

• Food Quality Protection ActFood Quality Protection Act (1996) (1996)

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SDWA 1996SDWA 1996

• Contaminant Candidate List (CCL)Contaminant Candidate List (CCL)– EPA publishes its regulatory agenda EPA publishes its regulatory agenda – There are no PPCPs on the current CCL – they could be added to CCL3 There are no PPCPs on the current CCL – they could be added to CCL3

• The Six Year Review -- The Six Year Review -- of existing NPDWRof existing NPDWR– There are no existing PPCP regulations; if they were developed would There are no existing PPCP regulations; if they were developed would

need to consider the following. need to consider the following.

• Use of best available, peer reviewed, publicly available Use of best available, peer reviewed, publicly available sciencescience

• Emphasis on protecting sensitive populationsEmphasis on protecting sensitive populations• Neither SDWA nor CWA allow EPA to require that Neither SDWA nor CWA allow EPA to require that

effects data be generated or submitted.effects data be generated or submitted.

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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 SDWARegulation under SDWA

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Clean Water Act Framework Clean Water Act Framework Protecting, Restoring U. S. WatersProtecting, Restoring U. S. Waters

Technology-Based Approach

Effluent limitation guidelines for point sources (available, affordable technology)

Water Quality-Based Approach

•EPA develops water quality criteria guidance

•States develop enforceable water quality standards using criteria

NPDES Permits

Nonpoint Source Program

Restoring Polluted Waters - TMDLs

Funding & Technical Assistance

Wetlands Protection

Watershed Approaches

Set Standards

Implement Programs

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Clean Water Act – WQ ApproachClean Water Act – WQ Approach

• Water Quality Standards Water Quality Standards – States designate use for water States designate use for water

– Water Quality Criteria (conditions supporting Water Quality Criteria (conditions supporting designated uses); EPA publishes national criteria (risk designated uses); EPA publishes national criteria (risk assessments)assessments)• Chemical criteria Chemical criteria

• Biological Criteria (apply to aquatic life designated uses)Biological Criteria (apply to aquatic life designated uses)

– States set standards; EPA approvesStates set standards; EPA approves

– Antidegradation (keeping good-quality waters in good Antidegradation (keeping good-quality waters in good condition)condition)

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Other CWA ApproachesOther CWA Approaches

• Effluent Guidelines for the Regulation of point Effluent Guidelines for the Regulation of point sources (more on this)sources (more on this)

• Combined Animal Feeding Operations RuleCombined Animal Feeding Operations Rule– Rule deals with nutrients – but results in less Rule deals with nutrients – but results in less

overall contamination of surface watersoverall contamination of surface waters– Discharge permits required for “large” CAFOsDischarge permits required for “large” CAFOs

• Fish Advisory programFish Advisory program• Guidance, voluntary programsGuidance, voluntary programs

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Effluent Guidelines & PPCPs -1Effluent Guidelines & PPCPs -1

• Pharmaceutical Manufacturing Industry (1998)Pharmaceutical Manufacturing Industry (1998)– Includes Includes

• Mfg of pharmaceutically active ingredients as defined by FDAMfg of pharmaceutically active ingredients as defined by FDA

• Only cosmetics containing pharmaceutically active ingredientsOnly cosmetics containing pharmaceutically active ingredients

– Regulation is based on performance of treatment / Regulation is based on performance of treatment / control technologies (rather than risk)control technologies (rather than risk)

– Limits on Biochemical Oxygen Demand, Chemical Limits on Biochemical Oxygen Demand, Chemical Oxygen Demand, Volatile Organic Contaminants, Total Oxygen Demand, Volatile Organic Contaminants, Total Suspended Solids, pHSuspended Solids, pH

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Effluent Guidelines & PPCPs -2Effluent Guidelines & PPCPs -2• Aquaculture (2004)Aquaculture (2004)

– Covers large facilities Covers large facilities • Flow through, re-circulating or net pensFlow through, re-circulating or net pens

• Directly discharge waste waterDirectly discharge waste water

• Produce 100,000 lbs fish / yearProduce 100,000 lbs fish / year

– Requirements include Requirements include • Best Management PlansBest Management Plans

• Prevent discharge of spilled drugs and pesticides; minimize Prevent discharge of spilled drugs and pesticides; minimize discharge of feeddischarge of feed

• Limit discharge of wastewater from harvest or transportLimit discharge of wastewater from harvest or transport

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What is EPA doing?What is EPA doing?

• Office of WaterOffice of Water– Building a PPCP Literature Database to actively track data Building a PPCP Literature Database to actively track data

– Coordinating with ORD and EPA Regional office on Coordinating with ORD and EPA Regional office on research areas (analytical methods, health effects, research areas (analytical methods, health effects, treatment)treatment)

– Participating in PPCP workgroups, attending conferences Participating in PPCP workgroups, attending conferences and tracking PPCP researchand tracking PPCP research

– Looking at options for CCL to handle contaminants that Looking at options for CCL to handle contaminants that may have occurrence data but no relevant health effects may have occurrence data but no relevant health effects datadata

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What is EPA doing?What is EPA doing?

• Office of Water cont…Office of Water cont…– Drinking water project with USGSDrinking water project with USGS

• Use of PPCPs as indication of fecal contaminationUse of PPCPs as indication of fecal contamination

• PPCPs are found many miles downstream from POTWs PPCPs are found many miles downstream from POTWs – hope to measure efficacy of drinking water treatment– hope to measure efficacy of drinking water treatment

• FY 06, USGS beginning in-house development of FY 06, USGS beginning in-house development of methods for PPCPs not covered in current capabilitiesmethods for PPCPs not covered in current capabilities

– Biosolids investigationsBiosolids investigations• Exploring occurrence of PPCPs in primary sludgeExploring occurrence of PPCPs in primary sludge

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What is EPA doing?What is EPA doing?

• Office of Research and DevelopmentOffice of Research and Development– Extramural STAR grantsExtramural STAR grants

– In-house research (e.g. - endocrine disrupting In-house research (e.g. - endocrine disrupting compounds (EDCs), analytical methods compounds (EDCs), analytical methods developmentdevelopment

– Scientific leadershipScientific leadership• Held ‘Pharmaceuticals in the Environment’ workshop in Held ‘Pharmaceuticals in the Environment’ workshop in

August 2005August 2005

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What is EPA doing?What is EPA doing?

• In general,In general,– Focusing on:Focusing on:

• Collecting information to evaluate the possibility of Collecting information to evaluate the possibility of prioritizing PPCP contaminantsprioritizing PPCP contaminants

• Developing analytical methodsDeveloping analytical methods

• Collaborating with other Agencies and workgroups to Collaborating with other Agencies and workgroups to reduce duplicative effortsreduce duplicative efforts