1. 1 EPA Regulatory Authority and PPCPs Octavia Conerly Health and Ecological Criteria Division Office of Water Office of Water October 26, 2005 October 26, 2005

2. 2 USEPA Disclaimer The contents of this presentation are the expressed opinions of the author and do not necessarily reflect the opinions of the USEPA.

3. 3 Presentation Outline EPA’s Enabling Legislation EPA’s Enabling Legislation Office of Water’s Major Legislative Authorities Office of Water’s Major Legislative Authorities – Safe Drinking Water Act – Clean Water Act OW PPCP Related Work (What is EPA doing?) OW PPCP Related Work (What is EPA doing?) Opportunities for Collaboration Opportunities for Collaboration

4. 4 EPA’s Enabling Legislation Is a very mixed bag of laws Is a very mixed bag of laws Dictate how we do our business and what we are capable of doing Dictate how we do our business and what we are capable of doing Are not always consistent with one another Are not always consistent with one another Often require science-based decisions Often require science-based decisions – e.g. SDWA 1996 requires use of best publicly available, peer reviewed science

5. 5 Legislative Authorities for Water Safe Drinking Water Act (1974), amended 1986, 1996 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. Clean Water Act (1977) Clean Water Act (1977) – Sets water quality criteria and guidelines and technology- based standards for ambient waters Food Quality Protection Act (1996) Food Quality Protection Act (1996)

6. 6 SDWA 1996 Contaminant Candidate List (CCL) Contaminant Candidate List (CCL) – EPA publishes its regulatory agenda – There are no PPCPs on the current CCL – they could be added to CCL3 The Six Year Review -- of existing NPDWR The Six Year Review -- of existing NPDWR – There are no existing PPCP regulations; if they were developed would need to consider the following. Use of best available, peer reviewed, publicly available science Use of best available, peer reviewed, publicly available science Emphasis on protecting sensitive populations Emphasis on protecting sensitive populations Neither SDWA nor CWA allow EPA to require that effects data be generated or submitted. Neither SDWA nor CWA allow EPA to require that effects data be generated or submitted.

7. 7 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

8. 8 Clean Water Act Framework Protecting, 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

9. 9 Clean Water Act – WQ Approach Water Quality Standards Water Quality Standards – States designate use for water – Water Quality Criteria (conditions supporting designated uses); EPA publishes national criteria (risk 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 approves – Antidegradation (keeping good-quality waters in good condition)

10. 10 Other CWA Approaches Effluent Guidelines for the Regulation of point sources (more on this) Effluent Guidelines for the Regulation of point sources (more on this) Combined Animal Feeding Operations Rule 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 Fish Advisory program Guidance, voluntary programs Guidance, voluntary programs

11. 11 Effluent Guidelines & PPCPs -1 Pharmaceutical Manufacturing Industry (1998) Pharmaceutical Manufacturing Industry (1998) – Includes Mfg of pharmaceutically active ingredients as defined by FDA Mfg of pharmaceutically active ingredients as defined by FDA Only cosmetics containing pharmaceutically active ingredients Only cosmetics containing pharmaceutically active ingredients – 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

12. 12 Effluent Guidelines & PPCPs -2 Aquaculture (2004) Aquaculture (2004) – Covers large facilities Flow through, re-circulating or net pens Flow through, re-circulating or net pens Directly discharge waste water Directly discharge waste water Produce 100,000 lbs fish / year Produce 100,000 lbs fish / year – Requirements include Best Management Plans Best Management Plans Prevent discharge of spilled drugs and pesticides; minimize discharge of feed Prevent discharge of spilled drugs and pesticides; minimize discharge of feed Limit discharge of wastewater from harvest or transport Limit discharge of wastewater from harvest or transport

13. 13 What is EPA doing? Office of Water Office of Water – Building a PPCP Literature Database to actively track data – Coordinating with ORD and EPA Regional office on research areas (analytical methods, health effects, treatment) – Participating in PPCP workgroups, attending conferences and tracking PPCP research – Looking at options for CCL to handle contaminants that may have occurrence data but no relevant health effects data

14. 14 What is EPA doing? Office of Water cont… Office of Water cont… – Drinking water project with USGS Use of PPCPs as indication of fecal contamination Use of PPCPs as indication of fecal contamination PPCPs are found many miles downstream from POTWs – hope to measure efficacy of drinking water treatment PPCPs are found many miles downstream from POTWs – hope to measure efficacy of drinking water treatment FY 06, USGS beginning in-house development of methods for PPCPs not covered in current capabilities FY 06, USGS beginning in-house development of methods for PPCPs not covered in current capabilities – Biosolids investigations Exploring occurrence of PPCPs in primary sludge Exploring occurrence of PPCPs in primary sludge

15. 15 What is EPA doing? Office of Research and Development Office of Research and Development – Extramural STAR grants – In-house research (e.g. - endocrine disrupting compounds (EDCs), analytical methods development – Scientific leadership Held ‘Pharmaceuticals in the Environment’ workshop in August 2005 Held ‘Pharmaceuticals in the Environment’ workshop in August 2005

16. 16 What is EPA doing? In general, In general, – Focusing on: Collecting information to evaluate the possibility of prioritizing PPCP contaminants Collecting information to evaluate the possibility of prioritizing PPCP contaminants Developing analytical methods Developing analytical methods Collaborating with other Agencies and workgroups to reduce duplicative efforts Collaborating with other Agencies and workgroups to reduce duplicative efforts