Pharmaceuticals in Drinking Water

1. Pharmaceuticals in Drinking Water NARUC Summer Committee Meetings July 20-23, 2008 Portland, OR Paul G. Foran VP, Regulatory Programs American Water

2. American Water is the largest water and wastewater services provider in North America, headquartered in Voorhees, NJ. American Water serves over 15.6 million people in 32 states and Ontario, Canada, and employs nearly 7,000 water professionals. American Water owns or operates over 870 water treatment plants & wells and 270 wastewater facilities. The company conducts over one million water quality tests each year for over 100 regulated parameters, and up to 50 types of water-related tests each day.

3. Where are we today: • What we currently know about the impacts of pharmaceuticals and personal care products (PPCPs) in our water supplies, USEPA plans and suggestions for action was summarized in hearings before the Transportation Safety, Infrastructure Security and Water Quality Subcommittee of the Environment and Public Works Committee of the United States Senate on April 15, 2008 • Testimony before the subcommittee can be accessed at the following web link: http://epw.senate.gov/public/index.cfm?FuseAction=Hearings.Hearing&Hearing_ID=30641a14-802a-23ad-4b51-a10dd439793f

4. The following persons testified at the subcommittee hearings and their comments are representative of a range of views about the issue: Benjamin H. Grumbles Dr. Alan Goldhammer Deputy Administrator for Water Deputy Vice President, Regulatory Affairs USEPA Pharmaceutical Research & Manufacturers Testifying on behalf of USEPA of America (PHRMA) Testifying on behalf of PHRMA Dr. Robert H. Hirsch Associate Director For Water David Pringle U.S. Geological Survey Campaign Director Testifying on behalf of the USGS New Jersey Environmental Federation Testifying on behalf of the N.J. Environmental Federation & Clean Water Action Dr. Shane Snyder Research & Development Project Manager Dr. Jennifer Sass Southern Nevada Water Authority Senior Scientist Testifying on behalf of the American Water Works Association National Resources Defense Counsel (NRDC) (AWWA) Testifying on behalf of the NRDC Some of the materials in this presentation are derived from their testimony, which is available in full through the web links on the previous page.

5. Pharmaceuticals in Water: Health Effects & Monitoring • “Studies have shown that pharmaceuticals are present in some of our nation’s water bodies. Further research suggests that there may be some ecological harm when certain drugs are present. To date, no evidence has been found of human health effects from pharmaceutical and personal care products in the environment. This includes drinking water sources.” • Source: USEPA Website • “The bottom-line conclusion is that the concentrations of pharmaceuticals we studied are orders of magnitude lower than would pose a public health threat.” • Benjamin Grumbles, Senate Subcommittee Hearing, April 15, 2008 • “In the absence of reliable data indicating potential risks associated with pharmaceuticals in water at the very low levels at which they have been detected, it would be inappropriate to require monitoring and/or treatment that could carry significant cost … Focus should be on contaminants with known significant health risks.” • Benjamin Grumbles, Senate Subcommittee Hearing, April 15, 2008

6. Why Now? • “Water professionals have the technology today to detect more substances – at lower levels – than ever before. These compounds are being found at levels 1,000 times lower than where drinking water standards are typically set.” • Source: AWWA website 04/15/2008

7. Upcoming American Water Works Association Report • “Based upon our four-year study of the health relevance of trace pharmaceuticals, using the highest concentrations found and the most conservative safety factors to protect susceptible populations such as infants and pregnant women, our report will demonstrate that one could safely consume more than 50,000 eight-ounce glasses of this water per day without any health effects. While the report will not be published until later this year, I can tell you that the bottom-line conclusion is that the concentrations of pharmaceuticals we studied are orders of magnitude lower than would pose a public health threat.” • Source: Testimony of Dr. Shane Snyder before Senate Subcommittee April 15, 2008 (Study referred to is being conducted by the American Water Works Association Research Foundation)

8. Perspectives: National Resources Defense Council • “Although the levels reported to contaminate our waterways are much lower than therapeutic doses, it would be naïve to think of this as ‘safe’, knowing that the agents are chemically reactive in our bodies, and that we are exposed daily over a life-time to multiple compounds in unknown combinations … Some additional elements of a solution may include reducing the unnecessary prophylactic uses of antibiotics and steroid hormones in agriculture, and excessive uses in humans, to tackle the problem at its source. There is no question that we will also need to invest in our waste water and drinking water infrastructure, and to monitor and treat for the chemical contaminants that present the biggest health risks, and that can be removed or reduced using cost-effective methods. Bottom line: our tap water is still the safest choice of drinking water available, but this problem won’t fix itself.” • Source: Dr. Jennifer Sass’ summary of her testimony before the Senate Subcommittee hearings on April 15, 2008 (Summary appears on NRDC website) (emphasis supplied)

9. Key Points of NRDC Position • The problem should be tackled at the source, not just at the water and wastewater treatment level • Monitoring and treatment requirements should be applied based on which contaminants pose the greatest risk to public health, and • That can be removed or reduced using cost effective methods. • Tap water is still the safest choice for drinking water available.

10. Uncertainties • There are no commercial labs certified by the USEPA to do pharmaceutical testing. • There are no USEPA approved standardized testing/analytical methodologies. • Testing results have not been comparable between laboratories.

11. Split Samples in Illinois • The Governor in Illinois required testing of large systems. • For one Illinois American system, the IEPA and the Company took samples from the same sources and sent the samples to different major commercial labs for analysis. • Samples were split between two labs: • Both use different methodologies; neither are USEPA certified for pharmaceutical testing • Lab A tested for 62 compounds Induced antibiotics, pharmaceuticals, personal care products, wastewater indicators • Lab B tested for 35 compounds Included endocrine disrupting compounds, pharmaceuticals, wastewater indicators • Of the 97 compounds tested, only 10 were the same between the two labs.

12. Raw Water Results • Only 2 compounds were detected by both labs • 3 compounds were negative by both labs • 5 of 10 test results differed between the labs

13. Finished Water Results • Only 3 compounds were detected by both labs • 2 compounds were negative by both labs • 4 of 9 test results differed between the labs

14. Raw Water Results

15. Scale: How much is a “Trace” level • “For example, in looking at a number of studies, the maximum reported drinking water level for caffeine was 0.12 parts per billion. At that concentration, a person would have to drink almost 220,000 gallons of water before coming close to ingesting the amount of caffeine that one would get from a six ounce cup of coffee.” • Source: Testimony of Benjamin Grumbles, USEPA Assistant Administrator for Water before Senate Subcommittee hearings April 15, 2008 • “You would have to drink more than 100 million gallons of water containing one part-per-trillion of acetaminophen to get the amount that would be found in an Extra Strength Tylenol.” • Source: Dr. Mark LeChevallier, Director, Innovation & Environmental Stewardship, American Water • “Many common food items (soybeans, vegetables, coffee) naturally contain phytoestrogens at levels hundreds or thousands of times higher than even the highest levels reported for water.” • Source: AWWARF Webcast, Dr. Shane Snyder

16. Where are we? • To date some research has indicated the possibility for some harm to certain aquatic life, but no evidence has been found of human health effects from PPCPs • No monitoring or treatment regulations currently exist for PPCPs • Available monitoring and treatment methods are extremely expensive and energy intensive, and effectiveness at monitoring or removing all potential PPCPs has not been established • Reverse Osmosis, membranes, ozonation, ultra violet light • Water service is already highly energy intensive • In California, approximately 20% of energy production is used in connection with treatment and transportation of water • Significant carbon footprint, greenhouse gas and climate change issues

17. Where are we? • A research and technological basis does not currently exist upon which effective regulations can be developed or implemented • Insufficient health effects research to determine the impact of trace levels or to prioritize which PPCPs are most hazardous • Effective testing methodologies have not been finalized • Flawed testing methods can cause undue alarm and result in unnecessary costs • Laboratories and analysts have not been certified to do the tests • Performance testing of analysts and analytical methodologies is not available • “caveat emptor”

18. Can we agree? • Drinking water regulations for PPCPs should be: • based on sound health effects research • cost effective • result in significant improvements to human health • More research, both as to health effects and to monitoring and treatment technologies is needed with regard to the effects of PPCPs in the environment and water supply • The national standard setting process established by Congress through the SDWA and administered by the USEPA and state primacy agencies is the appropriate forum to develop monitoring and treatment requirements for PPCPs

19. Can we agree? • A “holistic” approach is necessary to address the issue of PPCPs, which includes programs to stop the problem at its source, public education as to appropriate disposal procedures, as well as health effects based monitoring and treatment processes. • Public information programs should be developed that can address public interest and concern about the potential presence of PPCPs in the environment and water supply, without unnecessarily alarming or undermining confidence in the quality of their drinking water supplies.

20. Broader Policy Issues: • As science continues to develop more powerful (and more expensive) detection and treatment technologies, how do we balance the “ability to detect”, with the need to monitor and treat? • What role does the cost of monitoring and treatment for ever smaller quantities of potential contaminants play in developing these requirements? • Who should bear these costs? • How do we balance the costs of controlling for ever smaller levels of potential contaminants against other public health and social needs?

21. Broader Policy Issues: • How do regulatory standards of “prudence” impact these issues? • How do we keep customers informed about detection of trace levels of potential contaminants without unnecessarily undermining confidence in their drinking water supplies, in the absence of information about health or environmental impacts? • How do we ensure a comprehensive approach that brings in all responsible parties and stakeholders, e.g. FDA, pharmaceutical industry, end users of pharmaceuticals, etc. • In 1998, FDA raised the level of a chemical for which the pharmaceutical industry would have to investigate environmental impacts from parts per trillion to parts per billion.