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

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

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

EPA’s Enabling Legislation Is a very mixed bag of laws Dictate how we do our business and what we are capable of doing Are not always consistent with one another Often require science-based decisions e.g. SDWA 1996 requires use of best publicly available, peer reviewed science Depending on how you count there are 10 – 13 laws which provide EPA’s mandate Some laws require technology- based approaches rather than consideration of public health or eco risk. (e.g. CAA for some pollutants)

Legislative Authorities for Water 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) Sets water quality criteria and guidelines and technology-based standards for ambient waters Food Quality Protection Act (1996) A. At the onset of SDWA in the early 70’s, there was a big push to regulate everything. So NPDWR were made. B. These regulations were based more on the pure existence of a chemical and its suspected ability of result in health effects instead of what was actually in the drinking water. Mandated to set regulations for 25 contaminants every 3 years. (unrealistic) C. In 1996, Congress amended the Safe Drinking Water Act to emphasize sound science and risk-based standard setting, small water supply system flexibility and technical assistance, community-empowered source water assessment and protection, public right-to-know, and water system infrastructure assistance through a multi-billion-dollar state revolving loan fund. D. CWA is a 1977 amendment to the Federal Water Pollution Control Act (1972), which set the basic structure for regulating discharges of pollutants to waters of the US. Gives EPA authority to set effluent standards on a industry basis (technology-based); continued requirements for states to set water quality standards for all contaminants in surface waters. Other laws probably not related to ppcp include: Beaches Environmental & Coastal Health Act (BEACH Act) (2000); Coastal Zone Management Act; Endangered Species Act. FQPA may be relevant here as it deals with pesticides. FQPA amended FIFRA in 1996. Deals with pesticides – as pesticides are found in drinking water source waters, deals with SDWA . Highlights risks to children. Requires a new safety standard for all pesticides used on food – reasonable certainty of no harm. There are some pesticides which are also ppcp.

SDWA 1996 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 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 Emphasis on protecting sensitive populations Neither SDWA nor CWA allow EPA to require that effects data be generated or submitted. A. The 1996 amended SDWA requires EPA to publish a list of contaminants which are not subject to any proposed or promulgated NPDWR, are known to occur in public water systems, and which may require regulations under SDWA. Therefore, CCL. B. Names priority contaminants. Must determine regulatory status of 5 every 5 years. C. The 6 year review. Basically EPA must review every chemical with an existing MCL and check for a change in cancer classification or RfD. Must make determinations on 5 every 6 years. Done in stages. Stage I finalized December 1998. Stage II, May 2002. Unregulated contaminants rule requires drinking water systems to collect data on occurrence

Regulation under SDWA Regulate with NPDWR 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?

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 Set Standards NPDES Permits Nonpoint Source Program Restoring Polluted Waters - TMDLs Funding & Technical Assistance Wetlands Protection Watershed Approaches Implement Programs

Clean Water Act – WQ Approach 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) EPA has not yet developed criteria for ppcps as toxics. We could, given sufficient data and priority. States (and Tribes) have authority to designate uses of waters, develop standards for water, design programs (issue permits e.g.) to ensure that uses are met. EPA can disapprove standards, if they are not as protective and /or scientifically sound as EPA’s criteria.

Other CWA Approaches Effluent Guidelines for the Regulation of point sources (more on this) 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 CAFO rule dealt only with nutrients Animal feeding operations:1 animals confined and fed or maintained for 45 days in any 12 month period: 2 crops or vegetation are not part of the facility. Defines large, medium and small CAFOs CAFO rule estimated annual reduction of > 56 million pounds of phosphorous, > 110 million lbs sediment, > 911,000 lbs metals and reduced amounts of pathogens. Rule did not estimate reduction in ppcp Requires application for NPDES permits; chicken operations must apply for permits; must implement nutrient management plans; must submit annual report. Fish advisory program – EPA provides guidance to States and tracks their advisories. We did issue national advice on mercury in fish – jointly with FDA.

Effluent Guidelines & PPCPs -1 Pharmaceutical Manufacturing Industry (1998) Includes Mfg of pharmaceutically active ingredients as defined by FDA 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 The Effluent Guidelines for the Pharmaceutical Manufacturing Industry rule, finalized September 1998, regulates the discharge of pharmaceuticals and personal care products into navigable waters of the United States and into wastewater treatment plants by existing and new pharmaceutical manufacturing facilities. These effluent guidelines are national standards for wastewater discharges to surface waters and publicly owned treatment works (municipal sewage treatment plants). They are issued for categories of existing sources and new sources under Title III of the Clean Water Act. They are technology-based (i.e. they are based on the performance of treatment and control technologies); they are not based on risk or impacts upon receiving waters. But we do economic assessment. Different requirement for existing vs. new sources COD = chemical oxygen demand, VOC= volatile organic contaminants, BOD = biochemical oxygen demanding pollutants

Effluent Guidelines & PPCPs -2 Aquaculture (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 Aquaculture is really called Aquatic Animal Production Industry Effluent Guidelines Covered: Facilities that produce 100 K lb / yr in flow-through and recirculating systems that discharge at least 30 days / yr (trout, salmon, hybrid striped bass, tilapia) Facilities that produce 100 K lb / yr in net pens or submerged cages (salmon) Benefits caculated: reduce TSS by 500, 000lbs / yr; discharge BOD and nutrients by 300, 000 lbs /yr. PPCP reduction not calculater

What is EPA doing? 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 Literature Database being undated Peer-reviewed articles (1970’s – present) Searchable by author, title, keyword Contains over 400 citations Hard copies of articles cataloged Short summaries available for each article Database will be used to explore the utility of available data for evaluation of health effects

What is EPA doing? Office of Water cont… Drinking water project with USGS Use of PPCPs as indication of fecal contamination 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 Biosolids investigations Exploring occurrence of PPCPs in primary sludge

What is EPA doing? 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

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