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

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. 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

4. 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)

5. 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 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.

6. 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 Stage II, May 2002.
Unregulated contaminants rule requires drinking water systems to collect data on occurrence

7. 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?

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

9. 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.

10. 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.

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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