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S. HRG. 110–1247 

PHARMACEUTICALS IN THE NATION’S 

DRINKING WATER: ASSESSING POTENTIAL 

RISKS AND ACTIONS TO ADDRESS THE ISSUE 

HEARING 

BEFORE THE

SUBCOMMITTEE ON TRANSPORTATION SAFETY, 

INFRUSTRUCTURE SECURITY, AND WATER QUALITY 

OF THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

APRIL 15, 2008 

Printed for the use of the Committee on Environment and Public Works 

( 

Available via the World Wide Web: http://www.fdsys.gov 

(II) 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

BARBARA BOXER, California, Chairman 

MAX BAUCUS, Montana 

JOSEPH I. LIEBERMAN, Connecticut 

THOMAS R. CARPER, Delaware 

HILLARY RODHAM CLINTON, New York 

FRANK R. LAUTENBERG, New Jersey 

BENJAMIN L. CARDIN, Maryland 

BERNARD SANDERS, Vermont 

AMY KLOBUCHAR, Minnesota 

SHELDON WHITEHOUSE, Rhode Island 

JAMES M. INHOFE, Oklahoma 

JOHN W. WARNER, Virginia 

GEORGE V. VOINOVICH, Ohio 

JOHNNY ISAKSON, Georgia 

DAVID VITTER, Louisiana 

JOHN BARRASSO, Wyoming 

LARRY E. CRAIG, Idaho 

LAMAR ALEXANDER, Tennessee 

CHRISTOPHER S. BOND, Missouri 

BETTINA POIRIER, Majority Staff Director and Chief Counsel 

ANDREW WHEELER, Minority Staff Director 

SUBCOMMITTEE ON TRANSPORTATION SAFETY, INFRASTRUCTURE SECURITY, AND

WATER QUALITY

FRANK R. LAUTENBERG, New Jersey, Chairman 

BENJAMIN L. CARDIN, Maryland 

AMY KLOBUCHAR, Minnesota 

SHELDON WHITEHOUSE, Rhode Island 

BARBARA BOXER, California, (ex officio) 

DAVID VITTER, Louisiana 

CHRISTOPHER S. BOND, Missouri 

GEORGE V. VOINOVICH, Ohio 

JAMES M. INHOFE, Oklahoma, (ex officio) 

(III) 

C O N T E N T S 

Page 

APRIL 15, 2008 

OPENING STATEMENTS 

Lautenberg, Hon. Frank R., U.S. Senator from the State of New Jersey ........... 1 

Vitter, Hon. David, U.S. Senator from the State of Louisiana ............................ 2 

Boxer, Hon. Barbara, U.S. Senator from the State of California ........................ 3 

Klobuchar, Hon. Amy, U.S. Senator from the State of Minnesota ...................... 222 

Cardin, Hon. Benjamin L., U.S. Senator from the State of Maryland ................ 229 

Inhofe, James M., U.S. Senator from the State of Oklahoma .............................. 295 

WITNESSES 

Grumbles, Benjamin, Assistant Administrator for Water, U.S. Environmental 

Protection Agency ................................................................................................. 5 

Prepared statement .......................................................................................... 8 

Response to an additional question from Senator Cardin ............................ 23 

Responses to additional questions from: 

Senator Boxer ................................................................................................... 24 

Senator Inhofe .................................................................................................. 36 

Hirsch, Robert M., Associate Director For Water, U.S. Geological Survey ......... 196 

Prepared statement .......................................................................................... 198 

Responses to additional questions from: 

Senator Boxer ................................................................................................... 206 

Senator Cardin ................................................................................................. 213 

Senator Inhofe .................................................................................................. 214 

Sass, Jennifer, Senior Scientist, Natural Resources Defense Council ................ 232 

Prepared statement .......................................................................................... 234 

Responses to additional questions from: 

Senator Boxer ................................................................................................... 249 

Senator Cardin ................................................................................................. 254 

Senator Inhofe .................................................................................................. 255 

Goldhammer, Alan, Deputy Vice President, Regulatory Affairs, Pharmaceutical Research And Manufacturers Association ........................................... 259 

Prepared statement .......................................................................................... 262 

Responses to additional questions from: 

Senator Cardin ................................................................................................. 269 

Senator Inhofe .................................................................................................. 270 

Snyder, Shane, R&D Project Manager, Applied Research And Development 

Center, Southern Nevada Water Authority ....................................................... 273 

Prepared statement .......................................................................................... 275 

Response to an additional question from Senator Boxer .............................. 279 

Response to an additional question from Senator Cardin ............................ 279 

Responses to additional questions from Senator Inhofe ............................... 280 

Pringle, David, Campaign Director, New Jersey Environmental Federation ..... 284 

Prepared statement .......................................................................................... 286 

ADDITIONAL MATERIAL 

Letter; International Bottled Water Association (IBWA) ..................................... 296 

(1) 

PHARMACEUTICALS IN THE NATION’S DRINKING WATER: ASSESSING POTENTIAL RISKS 

AND ACTIONS TO ADDRESS THE ISSUE 

TUESDAY, APRIL 15, 2008 

U.S. SENATE, 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS, 

SUBCOMMITTEE ON TRANSPORTATION SAFETY, 

INFRASTRUCTURE SECURITY, AND WATER QUALITY, 

Washington, DC. 

The subcommittee met, pursuant to notice, at 3 p.m. in room 

406, Dirksen Senate Office Building, Hon. Frank R. Lautenberg 

(chairman of the subcommittee) presiding. 

Present: Senators Lautenberg, Boxer, Cardin, Klobuchar, and 

Vitter. 

OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, 

U.S. SENATOR FROM THE STATE OF NEW JERSEY 

Senator LAUTENBERG. This is a hearing on Pharmaceuticals in 

the Nation’s Water: Assessing Potential Risks and Actions, and we 

are pleased to bring the Committee to order. 

First, I want to say thanks to my colleague, the Chairperson of 

the Committee for her diligence in making sure that we are in constant activity reviewing our responsibilities and assessing what we 

can do to improve the environmental conditions as they exist in our 

Country. 

I want to welcome everyone to today’s critical hearing as we consider the impact of contaminants in our Nation’s water supply and 

the health hazards that they pose to our residents that is asserted, 

and we want to clear that up. 

Every day, all Americans across the Country rely on exactly the 

same thing, clean and safe water. When it comes to our drinking 

water, we have a reasonable expectation and that is that the water 

coming into our homes for ourselves and our families is clean and 

safe. That is why so many people were concerned about a news article that ran in March. The Associated Press ran a story that told 

America what many scientists already knew, that there were small 

amounts of drugs in the water that 41 million Americans drink 

every day. 

The study was conducted on water systems across the Country, 

including in my home State of New Jersey. While this story captured the public’s attention, there is more to it. The untold story 

is the absence of regulation by the Environmental Protection AgenVerDate Aug 31 2005 14:44 Sep 24, 2014 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\85529.TXT VERN
2 

cy and the many hundreds of unregulated chemicals that are permitted to flow into America’s water supply. 

There are more than 140 chemicals in our drinking water that 

flows in there without regulation or scrutiny, according to a study 

by the Environmental Working Group. These includes chemicals 

that are used in rocket fuel, gasoline additives, and pesticides. 

These are chemicals that have proven negative effects on people’s 

health. Even the EPA says that some of these chemicals can cause 

cancer. 

For some of these chemicals there is no health information on 

record in government materials. And yet all of these chemicals are 

unregulated. We drink them and they end up in our environment. 

We are already seeing the impacts of some of these contaminants 

in nature. For instance, it has been noted that we see in male fish 

carrying female eggs. What a contradictory thing that is in our ecological structure, our species structure. 

That is why I am concerned, and I know the public is concerned 

about the long-term impact of contaminated water. I know many 

people drink bottled water, but bottled water is not the solution. 

In fact, it may come as a surprise, but 40 percent of bottled water 

comes simply from the tap, 40 percent of the water. The cost is not 

to be ignored. It costs about a penny a gallon to get water from the 

tap. It costs $10 a gallon when it comes in a bottle. 

So it is essential that we work on this by increasing funding for 

protection from our crumbling water infrastructure, including our 

wastewater and drinking water facilities. Those facilities are responsible for cleaning up our water and they need the resources to 

do it. The EPA estimates that there is a $271 billion gap between 

what our wastewater treatment plants need and what they receive. 

We have to start closing that gap. 

And we need to continue to fund research on this issue. I was 

disappointed to see that the President’s budget cut the funding 

that we rely on to monitor our rivers and streams for contamination. The story that ran in the Associated Press focused on pharmaceuticals in the water, but I hope it is going to help us focus on 

the real problem, an EPA that has allows far too many unregulated 

contaminants in our water. 

I look forward to hearing from today’s witnesses about how we 

can better protect America’s water and the hundreds of millions of 

people who drink it every day. 

Now I will call on my Ranking Member, Senator Vitter, for his 

opening remarks. 

OPENING STATEMENT OF HON. DAVID VITTER, 

U.S. SENATOR FROM THE STATE OF LOUISIANA 

Senator VITTER. Thank you very much, Mr. Chairman. I will be 

very brief. 

I just want to thank all of our witnesses for coming and being 

part of this very important discussion. I know several of them have 

been focused on this issue both studying it, monitoring it, grading 

levels, and also trying to take proactive steps in mitigating that 

issue. I will be very eager to hear from them. 

And thank you for calling this important hearing. 

[The prepared statement of Senator Vitter follows:] 

3 

STATEMENT OF HON. DAVID VITTER, U.S. SENATOR

FROM THE STATE OF LOUISANA

Today the Senate Environment and Public Works Subcommittee on Transportation Safety, Infrastructure Security, and Water Quality will focus on pharmaceuticals in our nation’s waters. I thank the witnesses for being here. 

As we will hear from several of the witnesses today, the issue of pharmaceuticals 

in our nation’s waters is not a new one. I understand that the EPA first reported 

pharmaceuticals in US waters in 1975. 

With technological advances in the last few decades, there have been improvements in analytical methods that have led to the ability to detect trace concentrations in our waters to the parts per trillion (ppt). The ability to measure a tiny concentration of these compounds in the water does not necessarily mean that each of 

them will be harmful to people. It is likely that most of them would not have adverse health affects on the general population. Some studies have shown that pharmaceuticals measured in the water supply are at very low concentrations that are 

millions of times lower than a medical dose and at levels that do not pose an acute 

threat to public health. 

However, I do share concern about certain pharmaceuticals in drinking water supplies—endocrine disruptors, for example. There is research that suggests these impact aquatic species, and we should look very closely at any potential long term impacts on people. 

Unfortunately, there appears to be very little information about the chronic health 

effects of trace concentrations of pharmaceuticals in our waters on people, especially 

for those who are exposed to them for long periods of time. It is important that we 

better understand what the actual effects are on the public health in the long term. 

We need more health effects research on this topic before making sweeping regulatory changes. I look forward to hearing from the witnesses who have experience 

with the research that has been conducted to date. 

Senator LAUTENBERG. Thank you, Senator Vitter. 

Senator Boxer. 

OPENING STATEMENT OF HON. BARBARA BOXER, 

U.S. SENATOR FROM THE STATE OF CALIFORNIA 

Senator BOXER. Thank you, Senator. 

I just wanted to thank Senator Lautenberg for his extraordinary 

leadership on this and so many environmental issues. I am very 

proud to have the Subcommittee take the lead on this important 

matter, and I hope, Senator, you and Senator Vitter will get to the 

bottom of this. I will be here as long as I can. I have the technical 

corrections bill on the floor, so I will be going back and forth. 

But we are here today to conduct much-needed oversight on the 

presence of pharmaceuticals in our Nation’s water supplies. Clean, 

safe drinking water is essential to all of us. It is especially important to our children. 

The National Academy of Sciences has found that children drink 

more water and eat more food in proportion to their body weight 

compared to adults. In addition, children’s rapidly developing bodies, including their hormone systems that control their development, are very vulnerable. Pregnant women also undergo a host of 

similarly delicate changes. 

There are particular windows of vulnerability during our development when pregnant women and children may be especially susceptible to very low doses of some toxins. Some pharmaceuticals 

now being found in our water may affect our hormone systems. 

Many pharmaceuticals are designed to affect our bodies at very low 

levels. 

This all means that contaminants in water may have a more concentrated impact on pregnant women and children. It is because of 

the work by the United States Geological Survey, the Associated 

4 

Press and others, and I thank them for it, that we now know that 

some of our drinking water contains a mixture of pharmaceuticals. 

Notice I did not thank the EPA. Fish and wildlife that live in our 

waters are the familiar canaries in the coal mine. Scientific evidence is growing that small levels of contaminants, including pharmaceuticals, can damage reproduction and development in fish and 

wildlife. Our Chairman made that point about what is happening. 

Science is telling us to be careful. What are Federal agencies 

doing to prevent potentially dangerous exposures to pharmaceuticals in our drinking water? There is an answer, very little. 

EPA in particular has failed to adequately address this problem. 

EPA has failed to require the needed testing to determine the effects of these chemicals at low levels. 

In 1996, Congress told the EPA in the Safe Drinking Water Act 

and the Food Quality Protection Act to develop a program to identify and address chemicals that harm the natural balance of hormones in our body. Those are called endocrine-disrupting chemicals. Yet EPA is now nearly 6 years behind the scheduled established in a court settlement to list the endocrine-disrupting chemicals it will test. And EPA still has not even established all of the 

tests needed to detect these chemicals, much less evaluate the 

chemicals using those tests. 

EPA now says it is not prepared to require drinking water systems to monitor for pharmaceuticals or to set standards for pharmaceuticals in tap water because it doesn’t have the data showing 

harmful effects from low levels of exposure. So it is a real circular 

reasoning, isn’t it? You don’t do what Congress tells you. You don’t 

have the information, and when the pharmaceuticals show up and 

the AP does a front page story, you say, gee whiz, we would love 

to say something, but we don’t have enough information. 

This lack of data is in large part a result of EPA’s failure to ensure that companies that make these chemicals complete the testing needed to evaluate these effects. Because of these problems, 

EPA has not set a drinking water standard for a single pharmaceutical. In fact, EPA hasn’t even proposed to set a single health 

standard for any pharmaceutical in drinking water. 

The result of these failures is that millions of Americans turn on 

their kitchen taps and drink low levels of pharmaceuticals in their 

water every single day. The agency also should be doing much 

more to prevent these pharmaceuticals from getting into our water 

in the first place. For example, EPA should better address the disposal of pharmaceuticals and the releases of these chemicals from 

factories, farms, sewage treatment plants, and sewage sludge. 

Now, a White House working group that was supposed to address the pharmaceuticals in the environment and the related antibiotic resistance issues has missed its deadline to issue recommendations. The White House has insisted on keeping many 

records of this working group secret, which is unacceptable. All of 

the documents should be released to the public now. 

The Associated Press story published in March documenting 

widespread drinking water contamination with pharmaceuticals 

highlights the importance and impact of the public right to know. 

I am sitting next to the man who brought community right to know 

to environmental legislation. And Mr. Chairman, this is a classic 

5 

case in point. When people are told about contaminants in the 

water, they will start asking questions and maybe we will get 

something done. 

So in closing, I want to lay out five steps that I urge the Bush 

administration to take starting today. One, immediately release all 

of the secret records of the White House Working Group on Pharmaceuticals in the Environment; two, immediately start an accelerated testing process for pharmaceuticals and other toxic chemicals 

for the endocrine-disrupting effects, and you are late on that by 

years; three, immediately move forward with the process of establishing rules and programs to ensure the safe disposal of waste 

pharmaceuticals; and four, immediately ask water companies to 

voluntarily test their water for pharmaceuticals and disclose the results. 

Americans a right to expect that their government is ensuring 

that they can turn on their taps and have water that is safe, safe 

for their kids, safe for perhaps a sick grandma. And they have a 

right to know what is in their drinking water. We must protect 

those who are the most vulnerable, our children, pregnant women, 

and infants from this problem. It is our moral duty. 

Again, thank you very much, Senator Lautenberg, for your leadership. 

Senator LAUTENBERG. Thank you, Senator Boxer. 

And now our panel of witnesses are prepared to testify: Mr. Benjamin Grumbles, the Assistant Administrator for the Environmental Protection Agency’s Office of Water; Dr. Robert Hirsch, Associated Director for Water at the U.S. Geological Survey. I thank 

you both for joining us here. 

And now, Mr. Grumbles, if you would. Limit your testimony 

please to within 5 minutes, if we can do that. 

STATEMENT OF BENJAMIN GRUMBLES, ASSISTANT ADMINISTRATOR FOR WATER, U.S. ENVIRONMENTAL PROTECTION 

AGENCY 

Mr. GRUMBLES. Thank you, Mr. Chairman. It is always an honor 

to appear before the Committee. I am Benjamin Grumbles, Assistant Administrator for Water at the U.S. EPA. 

We are very concerned about this information. We are not 

alarmed in the sense of a risk to human health, but it does raise 

a big red flag and we are concerned and we are taking additional 

steps. We are taking this very seriously. 

America’s water supplies continue to be among the safest in the 

world, and we are committed to working with all our partners, including Congress, to ensure that it stays that way. Emerging contaminants are exactly that. They use the phrase emerging because 

there isn’t enough information yet to make a clear determination 

that there is a clear and present danger from them, but they cause 

concern. So that is why over the last several years, we and our 

Federal partners have been making extra efforts. We recognize that 

we need to continue to do that. 

Mr. Chairman, EPA has a four-pronged action plan to respond to 

the growing concerns about pharmaceuticals in water. The first is 

to continue to strengthen the science. We are fully committed to 

doing that. We are working with other Federal agencies. We are 

6 

asking the right questions. We are dramatically expanding the 

scope of the surveys and the studies that the U.S. EPA and other 

Federal agencies are doing to see what we know and to close the 

gaps between what we know and what we should know before we 

can take additional steps. 

We are conducting studies of fish tissue, and of sewage treatment 

plants, influent and the effluent to measure for the occurrence of 

pharmaceuticals. What we have found to date and also what the 

AP story has found, is that at truly tiny amounts, there are trace 

levels of pharmaceuticals in water, truly tiny trace amounts. 

The second part of our four-pronged action plan is to increase 

public understanding and improve risk communication. It is very 

important for the public to know they shouldn’t be rushing away 

from tap water to purchase bottled water based on alarmist headlines. When you translate it into the parts-per-trillion, it is the 

equivalent of having an aspirin-size pill in not one, but 100 Olympic-size swimming pools. It is important to provide the context. 

It is also important to be diligent and to take this matter very 

seriously, but improved risk communication is a key component of 

that, and that is why we have a website. That is why we are coordinating with others in the public sector and other policymakers 

to get this issue on the radar screen and to communicate clearly 

and effectively so the public can understand the extent of the risk. 

The third prong of our action plan is building partnerships for 

stewardship, working with other agencies, but also working with 

the public sector in a variety of ways. Specifically, EPA has several 

take-back pilot programs that we have been carrying out across 

this entire Country, not just over the last few weeks or months, but 

over the last several years—voluntary take-back programs of noncontrolled substances at pharmacies, working with institutions, 

universities, and working with communities. In the Great Lakes 

this month, there is a week where there will be voluntary takebacks of unused pharmaceuticals at various communities throughout the Great Lakes. It is important to increase product stewardship and pollution prevention through partnership programs, and 

that is a key component. 

The fourth component of our action plan is the regulatory tools, 

using the regulatory tools that we have when we get the appropriate amount of information, and when it is appropriate to take 

regulatory steps. We are taking that very seriously. We have developed three methodologies under the Clean Water Act last year, 

three methods for detection and measurement. We are carrying out 

a very important Public Health Service study right now under the 

Clean Water Act, the Effluent Guidelines Program, in hospitals 

and long-term care facilities, to determine what disposal practices 

they are using and to improve those disposal practices. We are 

committed to completing that study and to increasing the stewardship at hospitals. 

The other regulatory tool is under the Safe Drinking Water Act, 

and that is the contaminant candidate listing process. Mr. Chairman, we have a draft list of contaminants candidates for listing. 

We are taking additional comments. I have written to various organizations, every State in this Country, and every water utility, askVerDate Aug 31 2005 14:44 Sep 24, 2014 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\85529.TXT VERN
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ing them for their thoughts about adding pharmaceuticals to that 

list for potential regulation under the Safe Drinking Water Act. 

Mr. Chairman, in conclusion, we are taking several steps. I personally am going to be meeting with representatives of States, cities, utilities, the pharmaceutical industry and environmental 

groups in the coming weeks. We are looking at expanding our various studies. We are committed to taking action and to working 

with you to continue to ensure America’s drinking water supplies 

are among the safest in the world. 

I would be happy to answer questions from you and your colleagues. 

[The prepared statement of Mr. Grumbles follows:] 

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Senator LAUTENBERG. Thank you very much, Mr. Grumbles. 

Dr. Hirsch, please. 

STATEMENT OF ROBERT M. HIRSCH, ASSOCIATE DIRECTOR 

FOR WATER, U.S. GEOLOGICAL SURVEY 

Dr. HIRSCH. Mr. Chairman and members of the Subcommittee, 

thank you for the opportunity to provide the views of the U.S. Geological Survey on pharmaceuticals in the environment. I am Robert 

Hirsch, the Associate Director for Water at the USGS. 

The observed presence of pharmaceuticals in the environment 

has prompted public interest regarding potential adverse ecological 

effects and potential contamination of drinking water. The interest 

has already increased public awareness of the ways we handle and 

dispose of our medications and has resulted in interest by industries in treatment technologies and best management practices that 

are most effective at removing pharmaceuticals and other trace organic chemicals from our waters and our solid and liquid wastes. 

The USGS studies a wide range of chemicals of emerging environmental concern. Human and veterinary pharmaceuticals are 

only one class of chemicals in a group of contaminants that enter 

the environment via human and animal waste. These contaminants 

include many chemicals used in our homes, businesses and industries, including detergents, fragrances, fire retardants, disinfectants, plastics and insect repellants. 

Many of these chemicals are a new focus for environmental research because they are used in relatively small quantities and 

therefore were not expected to be of significant environmental concern. Recent findings have demonstrated that, for example, the 

manner in which we handle and dispose of our wastes can concentrate those chemicals in some environmental settings to levels 

that may be an ecological or health concern, and that pharmaceuticals have been entering the environment for as long as we 

have used them. 

In 1999, the USGS broadened its water quality science programs 

by initiating research on pharmaceuticals and other human and 

animal waste-related chemicals. By 2002, a USGS study had documented the presence of pharmaceuticals and other waste-associated 

chemicals in the Nation’s streams, and this report largely defined 

the issue in the United States. 

Since 2002, the USGS has published more than 160 reports that 

provide additional information on the occurrence of pharmaceuticals in various environmental settings, the sources of these 

chemicals to the environment, and to a lesser degree, the potential 

environmental health effects. 

The ecological effects of some pharmaceuticals found in the environment have been documented in the scientific literature. For example, it was not a surprise when antibiotics, which are designed 

to act as anti-bacterials, were found to have adverse effects on soil 

microorganisms at environmentally relevant concentrations. 

Testing also has found that some pharmaceuticals do not cause 

adverse effects in some organisms tested. In one study, three freshwater invertebrates were exposed to an anti-convulsant drug commonly found in the environment. Only one of the three species 

demonstrated an adverse effect. Significant uncertainty remains reVerDate Aug 31 2005 14:44 Sep 24, 2014 Jkt 000000 PO 00000 Frm 00200 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\85529.TXT VERN
197 

garding the effects of long-term exposure to levels found in environmental settings. 

Similarly, the potential human health effects of long-term exposure at the low levels of pharmaceuticals are not well understood 

and they do warrant continued study. 

The USGS has developed the capability to analyze for approximately 70 pharmaceuticals in environmental samples. We have collected and analyzed samples from approximately 1,500 sites across 

the Nation. Our current research focuses on four key priorities: 

one, assessing chemical loads of various sources, including wastewater treatment plants, animal feeding operations, landfills and 

other industrial facilities; two, evaluating ecological effects, for example fish endocrine disruption in streams enriched with 

wastewaters or anti-microbial resistance in setting where antibiotics are released to the environment; three, assessing the occurrence of pharmaceuticals in waters that are a source of drinking 

water and, to a lesser extent, in treated drinking water; and four, 

defining the comparative performance of varying water and wastewater treatment processes to remove pharmaceuticals and other 

chemicals. 

The USGS works with a number of Federal partners, including 

collaborations with the U.S. EPA, the CDC, NOAA and the Fish 

and Wildlife Service. As co-chair, along with U.S. EPA and the 

Food and Drug Administration, of the Federal Interagency Work 

Group on Pharmaceuticals in the Environment, we have seen increased coordination of Federal research, including discussions 

with the FDA to use their information from the drug approval process to prioritize the thousands of pharmaceuticals for environmental study. 

Similarly, results of USGS studies of environmental occurrence 

are used by many scientists to guide health-effect studies to assure 

that actual environmental conditions are being tested. 

We welcome the opportunity to provide any further information 

or assistance to the Subcommittee. Thank you, Mr. Chairman, for 

the opportunity to present this testimony. I will be pleased to answer any questions you or other members of the Subcommittee 

might have. 

[The prepared statement of Dr. Hirsch follows:] 

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Senator LAUTENBERG. Thank you very much, both of you. 

Mr. Grumbles, a recent environmental working group study 

showed that there are over 140 contaminants in our water supply 

that are unregulated and that EPA has not set safety standards 

for. In your comments, I heard you talk about the lack of data 

about some of these materials that we find in our water. Some of 

these chemicals, such as MTBE, gasoline additive, we note that 

that is a matter of great concern and can potentially cause cancer. 

That is acknowledged by the EPA. 

So how do you classify materials like this, chemicals like this, as 

cancer threats and then not propose any regulation about them? 

Mr. GRUMBLES. Mr. Chairman, I think the Committee and your 

counterparts in the House got it right in 1996, when you laid out 

a new process, an entirely new process under the Safe Drinking 

Water Act to use the best available science to focus on occurrence 

and health effects and if there were meaningful opportunities to reduce risk based on contaminants in the water supplies. 

We have been working through that new process. We think it 

works. It takes time. It takes a lot of time and effort. We are systematically reviewing hundreds and hundreds of chemicals for potential listing under the Safe Drinking Water Act. MTBE and others are good examples of ones where we are required to go through 

risk assessment, to develop based on the best available peer-reviewed science we have, and then go through a screening process. 

I can tell you, for pharmaceutical we are very interested in the 

potential listing of pharmaceuticals under the contaminant candidate listing process. We have not to date done so with one exception, nitroglycerin, but it is a proposed list and we are seeking additional comment from the public and from the scientific sector on 

the information, the data, the risks, and if there is a meaningful 

opportunity to reduce risk. If there is, then we would propose them 

for listing using the statutory criteria under the Safe Drinking 

Water Act. 

Senator LAUTENBERG. Yes, but if these materials can be identified as cancer-causing in some instances, how do you determine 

what the pace of review should be? Is there some numerical sequence that just says, OK, we will go down these lists and see what 

we find and when we get to list item 34, that, oh, yes, this one may 

be real dangerous. How do you determine what to go to first? 

Mr. GRUMBLES. For us, the science should drive the result and 

the greater the risk, then the greater the likelihood of taking action 

or regulatory action under the Safe Drinking Water Act. There are 

a variety of factors that we look at. We also in the new process that 

we have developed under the contaminant candidate listing, are 

seeking greater consultation from the science advisory boards in 

the scientific community. 

When there are specific threats or cancer risks, that gets our attention. That gets our attention to put a higher priority on the 

process. 

Senator LAUTENBERG. On the process. How about the product? 

Mr. GRUMBLES. Well, the process is—— 

Senator LAUTENBERG. You say it gets your attention. Well, OK. 

Mr. GRUMBLES. It gets our attention to go through and make a 

decision after we get an appropriate amount of information on the 

217 

type of risk to human health, and that involves a risk assessment. 

We need to also make determinations based on the level of occurrence. Do they occur at a frequency and at a level that is of concern 

to public health? And then the Administrator is charged with making the determination as to whether or not there is a meaningful 

opportunity to reduce risk. 

Senator LAUTENBERG. If we take something like MTBE, MTBE 

was said to cause cancer in animals many years ago. What do we 

way about MTBE’s presence in our drinking water? 

Mr. GRUMBLES. I think it is important. You are making a good 

distinction, too, that MTBE is not a pharmaceutical. There are a 

lot of potential chemicals in water that should receive review and 

they are receiving review by the agency. We are concerned as well 

about pharmaceuticals, but our higher focus has been on other 

chemicals and microbes. 

MTBE, our research and development office is carrying out and 

completing its risk assessment. I am not sure what the timeframe 

is for that, but they need to gather additional information on the 

risk so that we can then make a determination. 

We do have some standards or guidelines on MTBE, but it is not 

through the MCL process. It takes into account concerns about 

odor and taste, other aspects of drinking water. 

Senator LAUTENBERG. No, we are talking about MTBE is said to 

be cancerous in animals. It was done in 1994. So what are we discussing now about an evaluation? 

Mr. GRUMBLES. Well, we think MTBE is a pollutant that needs 

to be kept out of the environment, so we use various regulatory 

tools to prevent the pollution in the first place; in terms of safe 

drinking water or potential MCL regulation, setting a maximum 

contaminant level under the Safe Drinking Water Act. Where we 

are on MTBE is that the agency is carrying through on the additional research involved in the risk assessment for risk to human 

health, which is part of the criterion under the Safe Drinking 

Water Act. 

Senator LAUTENBERG. So is it appropriate to say that there is no 

cause for concern about human health, even though EPA itself said 

that it could cause cancer in animals? This now is 14 years ago. 

At what point do you say, wow, this stuff is bad for you? 

Mr. GRUMBLES. Well, I say it after I get the complete results 

from the scientific experts at the agency, in coordination with others. Certainly, Mr. Chairman, we are concerned about potential 

threats from environmental contamination by MTBE. But in terms 

of the data and information, I am not qualified to make some judgment about the risk to human health. We are concerned. We do 

have a risk assessment process underway. 

Senator LAUTENBERG. Your concern is not comforting, I can tell 

you that. Action is what we are trying to get here. 

I will call on my colleague, Senator Vitter, now for his questions, 

and we will come back again. 

Senator VITTER. Thanks, Mr. Chairman. 

Mr. Grumbles, I take it from your testimony you think the appropriate focus is on a somewhat broader issue than the topic of this 

hearing. This hearing is called Pharmaceuticals in the Nation’s 

Waters. I assume you think we need to be concerned with a numVerDate Aug 31 2005 14:44 Sep 24, 2014 Jkt 000000 PO 00000 Frm 00221 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\85529.TXT VERN
218 

ber of things that may be in the Nation’s waters, whether they are 

pharmaceuticals or other contaminants, figuring out if they are a 

danger to human health in the amounts in which they may appear 

in the Nation’s waters. Is that fair to say? 

Mr. GRUMBLES. Yes. 

Senator VITTER. OK. Based on what we know so far, are pharmaceuticals as a class of more concern than all the other stuff that 

you are also looking at? How would you make that distinction? 

How do you prioritize the scientific work with regard to pharmaceuticals versus other possible contaminants? 

Mr. GRUMBLES. I start by reiterating that America’s water supplies are among the safest in the world. One of the greatest buys 

for Americans today is municipal tap water because of the cost and 

the safety and cleanliness of it. 

We always face challenges and for years and to this day, the biggest challenges continue to be various types of microbial or industrial chemicals of concern. Pharmaceuticals and personal care products are certain types of chemical that are an emerging concern. 

We are concerned. We are not alarmed. We have known for years 

as a scientific agency that there are truly tiny trace amounts of 

pharmaceuticals in water. 

We feel it is very important to be aggressive, to be aggressive in 

stepping up the amount of research and product stewardship. The 

pharmaceutical industry and municipal water utilities need to do 

more, just as we are doing more. One of the key messages from the 

U.S. EPA is pollution prevention and product stewardship. 

That is why though the guidance issued in January 2007 that 

HHS, EPA and the Office of National Drug Control Policy issued 

is important because it has the basic message of the toilet should 

not be a trash can. You should not dispose of unwanted or unused 

pharmaceuticals by flushing them down the toilet. There are a 

handful of exceptions, controlled substances, that specifically on the 

label say flush in the toilet because of concerns about security and 

getting into the hands of those in violation of the Controlled Substances Act. But the general message should be product stewardship, don’t flush it down the toilet, and properly dispose of it. 

Sometimes that means securing it, like in kitty liter or coffee 

grounds, and putting it in a bag and disposing of it in the trash. 

We think it is very important. We look to work with the Committee to encourage stewardship across this Country in terms of 

voluntary take-back programs that comply with the Controlled 

Substances Act, but that also get the pharmacies more involved, 

and encourage the pharmaceutical industry to use a life-cycle analysis and take ownership in helping to return unused or unwanted 

pharmaceuticals so they don’t get into the sewer systems or in the 

water supplies of this Country. 

Senator VITTER. OK. Thank you. 

To followup on the Chairman’s question, and he was specifically 

using the MTBE example, I take it that a big issue there, or in a 

lot of these cases, is in what amounts we find any of this in any 

water, and whether a true trace amount is a danger to human 

health. Is that correct? I assume dosage is a huge part of this 

whole discussion and research. 

219 

Mr. GRUMBLES. That is exactly right, Senator. One of the reasons 

why one of the prongs of our action plan is risk communication, is 

to help increase public understanding of the context of the risks involved. The dose makes the poison, essentially. The dose is the critical factor. While we should be concerned about the pharmaceuticals in water, we should also remember that these are showing up in truly trace amounts and that we don’t have any evidence 

to date of a risk to human health. 

That doesn’t mean we should stop looking. It doesn’t mean we 

should stop doing the research, and there is a lot of research that 

needs to be done, and actions as well. In my office, we are focused 

on looking at regulatory tools and also increasing public and private stewardship of the products. The dose makes the poison. It is 

the level and that is one of the key components to keep in mind. 

When you are talking about industrial chemicals or microbials, 

one of the reasons why over the last several years we have issued 

final rules under the Safe Drinking Water Act is to get at those 

known, clear risks like protozoa or other types of bacteria or viruses that can show up in surface water or groundwater, or industrial chemicals or disinfection byproducts as a result of 

chlorination. Those have been our priorities. Pharmaceuticals are 

an emerging concern and a growing priority for us, but at this 

point the scientific jury is still out on just how great a risk it presents to public health. 

Senator VITTER. OK. 

Dr. Hirsch, sort of following up on that, you said in your testimony that the effects of long-term exposure to the low levels of 

pharmaceuticals found in the environment on human health are 

not understood and warrant continued study. Looking to USGS in 

particular, what do you think would be the most productive things 

for you all to do with regard to that study? 

Dr. HIRSCH. I will say two things. One of the things that really 

we try to focus on is trying to understand the relevant levels that 

we would expect to find in the environment. We look across a range 

of environments from those that we would expect to see some of the 

highest concentrations, and also places where we would expect to 

see the lowest, to help inform the agencies that have responsibility 

for testing and regulation in this area, particularly EPA, but also 

the Food and Drug Administration, to understand what those environmentally relevant levels are so that the testing can be done at 

those levels. 

We also do ecological effects research in our Biological Division, 

where we do look at the effect of a variety of chemicals, including 

these, the pharmaceuticals, on a variety of aquatic organisms, not 

for purposes of understanding human health, although it may be 

relevant there, and can be extended to that, but directly to understand the effects on certain kinds of species to see whether, for example, there is endocrine disruption and reproductive effects on 

various species. Those are areas that we are working on. 

Senator VITTER. OK. Thank you very much. 

Thank you, Mr. Chairman. 

Senator LAUTENBERG. Senator Boxer. 

Senator BOXER. Thank you. 

220 

Mr. Grumbles, you say the toilet shouldn’t be a trash can for unused medications. At the same time you are saying that, the White 

House Office on National Drug Control Policy says the FDA advises 

the following drugs be flushed down the toilet. 

So look, you don’t know what your other hand is doing. I understand they are looking at it a different way. Get together. Get together. After this AP story scared everybody, including you, you 

said you are concerned, don’t come up here and say don’t use the 

toilet to flush your drugs down when you have a whole other arm 

of your very own Administration telling people to flush the drugs 

down the toilet. 

There are a lot of words here between the two of you. Not much 

is getting done. Let’s face it. And conflicting messages are going 

out. 

Mr. Grumbles, you said very nicely that you really are concerned. 

I appreciate that. I really do. Then why is it that your budget 

slashed funding for EPA endocrine-disruptive chemical testing program that Dr. Hirsch said is so important? Why did you cut it 35 

percent? And why did Mr. Johnson come up here and say he was 

fine with the cuts across the board, whatever they were for EPA? 

Mr. GRUMBLES. Two points or two responses. One, I acknowledged, Madam Chair, that on the guidance that we issued, which 

is not cast in stone, it can be revised; the guidance we issued we 

said there are some specific pharmaceuticals that on the label say 

flush them down the toilet. It is because of the Controlled Substances Act. The Federal agencies did work together and we are 

committed to working with the pharmaceutical industry to remove 

some of those from the list so that they don’t continue to say flush 

it down the toilet. 

Senator BOXER. OK, sir, sir, sir. I am just making a point in evidence, that while you said, and I have your testimony here, you 

said it. You didn’t couch it. You said don’t use the toilet as a trash 

can. At the same time, another entity is saying flush these down 

the toilet. 

Now, what I am suggesting is, I understand the reasons they are 

saying it. Believe me, I do. I understand why oxycontin is so dangerous you don’t want it lying around. I understand. I get it. But 

there has to be a way for agencies to get together. When a story 

like this breaks, why is it necessary for Senator Lautenberg to 

have to call a meeting of the Subcommittee? Why aren’t you working day and night on this? Why aren’t you saying to me today, we 

have had a meeting with the FDA, we are working together, we are 

coming to you as Chairman and Subcommittee Chair, we are going 

to work together. 

I am with you on a voluntary program. Let’s do it. But this is 

what is going on and why people do get upset with their government. 

So if we could get on to the budget cuts, if we could. Because we 

will work together with you to square this away. 

Mr. GRUMBLES. Thank you. 

Senator BOXER. But if you could please tell us about these budget cuts in this very important program that Dr. Hirsch said we are 

doing the work. How does he do the work when you are giving him 

a 35 percent cut? 

221 

Mr. GRUMBLES. In putting together a $7 billion budget, there are 

tough decisions that have to be made. 

Senator BOXER. Obviously. 

Mr. GRUMBLES. Another example is there are programs that have 

worked well, that we initiated funding in, that have matured or 

have graduated into being self-sustaining programs on the funding 

such as the work with healthy hospitals. 

Senator BOXER. I am talking about a 35 percent cut to the endocrine-disrupter chemical program, just answer this, where you were 

supposed to start the work in 1999. You haven’t listed anything. So 

I do not understand how you can propose and live with a 35 percent cut in this program that Dr. Hirsch says is important. 

Mr. GRUMBLES. What I know is that the agency has proposed 

listing 73 pesticides and we are moving forward with that program. 

They did get off to a slow start. What I don’t know, Madam Chairman, and I am not in a position to give you the specifics on, but 

I know that we will followup with specifics describing the 35 percent cut or how it was made. 

Senator BOXER. I think it speaks for itself, with open checkbook 

for Iraq, open checkbook for them, but we can’t find a few dollars 

here to protect the public from what could be a threat to pregnant 

women and children. That is rather stunning. 

Mr. Grumbles, your testimony refers to the White House-convened Pharmaceuticals in the Environment Working Group. This 

group was supposed to make recommendations last December. Has 

that happened? 

Mr. GRUMBLES. My understanding is that the schedule is to 

make recommendations to develop a research strategy by the end 

of this year. 

Senator BOXER. Have they made the documents public? It is my 

understanding they have made no documents public. 

Mr. GRUMBLES. I am not sure what the status is. 

Senator BOXER. Do you think they should make their documents 

public, this working group, the Pharmaceuticals in the Environment Working Group? Will you provide this Committee with all 

EPA records related to the Pharmaceuticals in the Environment 

Working Group within 10 days? 

Mr. GRUMBLES. I can’t answer the specifics, Madam Chair, because I don’t know what documents we are talking about. What I 

know is that the group—— 

Senator BOXER. Any and all documents that this group worked 

on. We have a job here to do, oversight. Will you make those documents available to us? Because no one else can get them. 

Mr. GRUMBLES. Well, I think the right entity to ask that question 

is the Office of Science Technology Policy because they are the ones 

overseeing it. 

Senator BOXER. No. I am just asking for the EPA records. I am 

not asking you for others. You are one of the co-chairs of that working group, not you personally. 

Mr. GRUMBLES. Not me personally. 

Senator BOXER. Not you personally, but EPA. 

Mr. GRUMBLES. Madam Chair, what I would commit to you is 

that EPA in terms of its role and in its involvement in that task 

force, when I get back from the hearing, I will talk with those who 

222 

are, the Research and Development Office and others in the agency 

that are involved in this, to try to provide whatever we can that 

reflects our involvement in this. 

Senator BOXER. What reason would there be to not make those 

documents available to Senator Lautenberg, Senator Vitter and 

myself, Senator Klobuchar? Is there a national security reason 

here? What is the story? 

Mr. GRUMBLES. I don’t know that there is a reason. I also know 

that the work group is committed to making information available, 

developing that research strategy that will help inform the agencies and benefit the public. 

Senator BOXER. OK. My time is up on this round, so let me just 

say I look forward to receiving those documents, otherwise we will 

have to consider getting them a different way. I am sorry I went 

over my time. 

Senator LAUTENBERG. We are joined by Senator Klobuchar. 

OPENING STATEMENT OF HON. AMY KLOBUCHAR, 

U.S. SENATOR FROM THE STATE OF MINNESOTA 

Senator KLOBUCHAR. Thank you very much, Senator Lautenberg. 

I appreciate it, because I am going to manage the bill at 4 o’clock, 

and if I could just have a few minutes here. 

I thank our witnesses for being here. Obviously, this is something of great concern to our State, the State of Minnesota, which 

is the land of 10,000 lakes, and actually have even more lakes than 

that. 

The fact is that small quantities of drugs, including antibiotics, 

sex hormones, caffeine and anti-seizure medications have been 

found in drinking water supplied to over 40 million Americans 

across the Country. My concern is that instead of engaging in action, that the EPA is once again dragging its feet. 

Senator KLOBUCHAR. I just have one or two questions before I 

have to leave, Mr. Grumbles. Right now, my first question would 

be that local water treatment plants are not required to test for 

pharmaceuticals. Is that correct? 

Mr. GRUMBLES. That is correct, in the sense that if pharmaceuticals are not listed or regulated under the Federal Safe Drinking Water Act, they are not required under the Safe Drinking 

Water Act to monitor for it, to test for them. 

Senator KLOBUCHAR. And do you think that this is a good idea 

that they are not being tested? 

Mr. GRUMBLES. I think that we should look very seriously, very 

carefully at using our tools under the Safe Drinking Water Act. As 

we gather the necessary information to make those decisions on 

whether to list some pharmaceuticals for potential regulation or 

monitoring, we should do everything we can to encourage water 

utilities to share with their consumers, their public, any information they have that would be relevant to them. 

Senator KLOBUCHAR. Is it true that the testing is only $1,000? 

Mr. GRUMBLES. I don’t know from a personal standpoint. I have 

seen that as one of the items. We are encouraging, and I appreciate 

Chairman Boxer’s suggestion. We as an agency, the Water Office, 

is encouraging water utilities to be more vigilant and to test. I have 

seen personally that they are increasingly, and they want to gather 

223 

more information and know about the potential for emerging contaminants in their product, their water supply. 

Senator KLOBUCHAR. I know in your written testimony you focused on the research that EPA is starting to do in this area. One 

of the things I was thinking as I read that is that it might be better to spend some of these funds to help local communities develop 

drinking water systems that may eliminate such contaminants. 

I will tell you that in Minneapolis, a new ultra-filtration plant 

opened in 2005, and when a second plant is completed in the next 

3 years, Minneapolis will be the largest city in the Country to have 

all its water processed by ultra-filtration. We like to say we have 

the best drinking water in the Country. We actually bottle our 

Minneapolis drinking water. 

This is cutting edge, and we are able to meet the standards. I 

think it is harder for some of our smaller towns in our State and 

across the Country to meet these kinds of standards. 

Mr. GRUMBLES. If I could say that it is important to continue to 

develop the technology. It can be expensive at times, but that is an 

important area for further research. The other one that we are focused on, the actions we are taking are providing financial and 

technical assistance to some communities or institutions to develop 

better practices for proper disposal, whether that is hospitals or 

other types of institutions. That, too, is in the name of pollution 

prevention and will go a long way as we continue to gather information about the degree of risk to aquatic life or even human 

health. 

Senator KLOBUCHAR. I will have to tell you when I read that AP 

article about how your position is there needs to be more searching 

and more analysis. 

Mr. GRUMBLES. Not paralysis. 

Senator KLOBUCHAR. Searching and more analysis. 

Mr. GRUMBLES. We understand that there needs to be action. 

Right now, it is focused on building partnerships for stewardship 

and looking very closely at potential regulatory tools. We have used 

some enforcement tools. We just recently reached a supplemental 

environmental project in an enforcement context with a wastewater 

treatment facility. As part of a supplemental environmental 

project, they were putting more effort into proper disposal of pharmaceuticals and increasing public awareness about proper disposal 

of pharmaceuticals. That was in the context of a Clean Water Act 

enforcement action. 

Senator KLOBUCHAR. What kind of actions were you taking before this story came out? I am just kind of curious because it was 

news to a lot of us that even though it is small traces—— 

Mr. GRUMBLES. I know personally 2 years ago I sent around a 

memorandum to all the EPA offices and the regions to increase our 

efforts in the National Water Program. I know that the Research 

and Development Office at EPA has been carrying out extensive research over the years, over the last six or 7 years, on this front. 

We have been gathering information not just about the cuttingedge technologies, but also several years ago we started sampling 

for sewage sludge. 

Senator KLOBUCHAR. But still, you have been doing all this, but 

then suddenly we hear about all these things in the water. What 

224 

I am concerned about, have you listed these things? Have you 

made this public? Because for a lot of us, as I said, and a lot of 

citizens in this Country, this was news to them. It really shouldn’t 

take a newspaper article to get this story out. 

Mr. GRUMBLES. We have shared information, but what we have 

yet to do is make some conclusion that there is a risk to human 

health and that the other factors under the Safe Drinking Water 

Act have been triggered by the presence of these tiny trace 

amounts. 

Senator KLOBUCHAR. When are you going to make this finding? 

Mr. GRUMBLES. There are various programs. We are, as I was 

mentioning earlier, we have a contaminant candidate listing process under the Safe Drinking Water Act. It is open. We proposed 

candidates for contaminant listing. There was only one pharmaceutical on that list, and it really was not listed as a pharmaceutical per se. 

The comment period closes in the coming weeks, on the 21st of 

May. In the meantime, what we have done is we have written to 

potentially interested stakeholders or officials, State and local 

water officials, saying should we add some pharmaceuticals to that 

list. So that is one example of a potential regulatory listing process. 

Senator KLOBUCHAR. Again, I have to go or I will turn into a 

pumpkin here. My concern here is just that you have talked a lot 

about potential listing and things you can do. Meanwhile, we know 

some things that work. I brought up this filtration system. I think 

you know that works. Shouldn’t we be focused more on results to 

do everything we can to make our water safe? That is what I am 

urging you to do here because I am concerned there hasn’t been 

enough action. 

Thank you. 

Mr. GRUMBLES. Thank you. 

Senator LAUTENBERG. We have a few questions that members 

here want to ask, so we will continue for a bit. I will start, Mr. 

Grumbles, by confirming that the Clean Water State Revolving 

Fund is the place that problems get cleared up. Is that not correct? 

Mr. GRUMBLES. It is an important tool. It is not the only tool. I 

think the non-point source program is another tool. There are other 

programs and tools. 

Senator LAUTENBERG. This is an important part of the mechanism for cleaning up, is it not, the State revolving fund? 

Mr. GRUMBLES. For protecting the environment, it is an important part. 

Senator LAUTENBERG. Yes. So how do we justify a cut in the 

budget proposal of 20 percent for the next budget? How does that 

strike with the work that remains to be done? 

Mr. GRUMBLES. It is entirely consistent with the Administration’s 

vision of the State revolving fund, and that is that eventually over 

time it would be self-sustaining. 

Senator LAUTENBERG. Do you believe that? Do you believe that 

giving it a good hefty 20 percent cut is going to lead to its self-funding? 

Mr. GRUMBLES. I think it needs to be coupled with several 

things. That is where the four pillars of sustainability come in to 

play. But also, Mr. Chairman, I think that Congress needs to enact 

225 

a water enterprise bond initiative, some innovative financing to 

bring additional funding. 

Senator LAUTENBERG. But for now, there is not enough work to 

be done that a 20 percent cut would not impair? 

Mr. GRUMBLES. We know there are needs. We also know that 

States and localities need to step up and full-cost pricing needs to 

be an important part of the equation. 

Senator LAUTENBERG. Yes, but does it matter that there is a 20 

percent cut? 

Mr. GRUMBLES. No, we think that there are other tools that need 

to be used as well. 

Senator LAUTENBERG. I want you to be more precise. Does it 

matter if there is 20 percent cut in the State Water Revolving 

Fund? 

Mr. GRUMBLES. We think that the cut is—— 

Senator LAUTENBERG. What do you think? You are a professional. What do you think? 

Mr. GRUMBLES. Well, I support the Administration’s budget on 

this. 

Senator LAUTENBERG. OK. So whatever the Administration’s 

budget does, you are Johnny OK with that? 

Mr. GRUMBLES. Mr. Chairman, the position of the agency and my 

position as well heading up the National Water Program—— 

Senator LAUTENBERG. But how do you feel about it? Are you 

being mechanical about this? 

Mr. GRUMBLES. I feel that now is a great opportunity for the 

Congress to not just focus on the SRF, to continue to support the 

SRF, and we agree that is important, too, but to use new tools and 

the broader tools to change the paradigm. 

Senator LAUTENBERG. So in your view, the fact that right now at 

this point in time, with the work that your department has, that 

a 20 percent cut in resource doesn’t really mean a heck of a lot. 

Mr. GRUMBLES. No, Mr. Chairman. I would say that it is important to step up and increase efforts in a variety of programs and 

ways. 

Senator LAUTENBERG. If you only had two words you could issue, 

yes or no, which one would you pick, Mr. Grumbles? 

Mr. GRUMBLES. Would you repeat the question? 

Senator LAUTENBERG. It is a very serious question. You are a 

professional. You know what goes on there. You understand what 

kind of risk there is. 

Mr. GRUMBLES. Is a 20 percent cut in the SRF acceptable? 

Senator LAUTENBERG. We will let you go with that. I would rather put it my way and say, would you recommend a 20 percent cut? 

Do you personally, you a professional, Mr. Grumbles, do you professionally think that a 20 percent cut is in order in the State revolving fund, with the work you have ahead of you? 

Mr. GRUMBLES. Given the budgetary pressures that we have on 

our other programs, that it is entirely consistent with our agenda 

and our priorities, so yes there needs to be an increase in other efforts. 

Senator LAUTENBERG. Thank you very much, Mr. Grumbles. I appreciate your illuminating comment. 

226 

Dr. Hirsch, the USGS has conducted studies on the amount of 

contaminants in our water from pesticides to antibiotics to pharmaceuticals. Do you believe that improving our wastewater treatment 

infrastructure would effectively reduce concentrations of those contaminants? 

Dr. HIRSCH. We have been doing some work with State and local 

agencies in fact, some in New Jersey and some in New York in particular, looking at both wastewater and drinking water facilities 

and trying to understand how much of these chemicals are removed in either the wastewater process or the drinking water 

treatment processes. We find that there are significant differences 

in the effectiveness of these facilities based on the kinds of processes they use. 

So clearly, as in the previous questions about Minnesota, comments about Minnesota, that some of these technologies are probably a part of resolution of the potential concerns over pharmaceuticals in our water supply. 

Senator LAUTENBERG. So, again being very specific, would improving our wastewater treatment infrastructure, might it substantially reduce the concentration of contaminants? 

Dr. HIRSCH. I think it would be correct to say it might. I think 

there are a tiny handful of studies that are beginning to point in 

that direction. 

Senator LAUTENBERG. OK. Thank you. You are both good 

landscapers. You caught the hedges. 

[Laughter.] 

Senator Vitter. 

Senator VITTER. Thank you, Mr. Chairman. 

I just wanted to very briefly followup on two points. One is just 

a statement. I think if we look at the record, just to clarify, when 

Mr. Grumbles was talking about this issue of not using the toilet 

as a trash can and flushing things down the toilet, he specifically 

said in his original statement that there were some exceptions to 

that rule and there were some pharmaceuticals that the current 

science says should be flushed down the toilet because of other 

overarching concerns. So I just wanted to clarify that, which I 

think you will find in the record. 

The second point goes to Senator Klobuchar’s comments, and I 

would ask both witnesses to answer in turn. I assume there are 

tens of thousands or more of pharmaceuticals or other agents that 

we could mandate testing for today. I assume that there are tens 

of thousands or more of these agents that we could mandate an absolute zero tolerance policy for in terms of water cleanup. 

Would you consider it the right policy to mandate that now with 

regard to every entity pharmaceutical or other contaminant out 

there, to mandate testing and to mandate zero tolerance for all of 

those things based on the knowledge and the science we have? 

Dr. HIRSCH. Let me start by just saying I think it is clear that 

it is highly unrealistic to test for every chemical in our environment and the costs would be enormous. The question of the kinds 

of stewardship things that Ben Grumbles talked about—I think we 

have to ask the tradeoffs of those expenditures. Just an analysis 

of about 70 pharmaceuticals in a single water sample costs about 

$2,500. To be meaningful, you would have to do it repeatedly 

227 

through the course of the year at every single facility in the Nation. 

Particularly for smaller communities, that is an enormous amount 

of money and we simply don’t know what the meaning of those results would be, to say that there is one part per trillion of this and 

two parts per trillion of that. 

So I think there is a need for prudence about what needs to be 

mandated testing and what needs to be an action level in a regulatory sense. This is a subject matter that is still very new both in 

terms of developing of testing for the presence of it and the testing 

of the effects. 

Senator VITTER. It seems to me that before we test, we have to 

know what the significance of the test result is going to be, what 

it means to human health or doesn’t mean to human health. And 

therefore, it needs to start with that science. Would you agree with 

that basic premise? 

Dr. HIRSCH. I think there is a need for there to be a feedback 

in this process. One needs to begin to know something about what 

is present in the environment in order to help the targeting of the 

research on effects, and then the effects work can feed back to determining things that ought to be widely tested for. I think there 

needs to be a flow of information in both directions. 

I would comment that the task force that some of you have been 

asking about, that is precisely the things that are going on in that 

OSTP task force, which is the trading back and forth of information 

among the various agencies as to the quantities of various chemicals that are being introduced, and what we are learning about 

their presence. It is helping all of us to better target our work. 

Mr. GRUMBLES. I would just simply add that I agree with everything Bob said. But I also would say, I do worry about the tradeoffs. When you go to mandate testing and monitoring for a risk 

that may be a much smaller risk, there may be some significant 

tradeoffs. 

A perfect example is coastal recreational waters. Mr. Chairman, 

I know how committed you are and your leadership in that area. 

We know that bacteria in coastal waters, different types of pathogens, are real and present danger, a risk to human health. So that 

is an area that deserves priority—priority testing and continued increase in the criteria and standards under the Clean Water Act. 

That is a good example of an area for priority. The SRF is an important tool in helping to reduce pollution that ultimately gets to 

the beach, but it is not the only tool. 

We have increased our enforcement efforts, Mr. Chairman, 

against sewer overflows, particularly in coastal communities, because we see the writing on the wall that that can add risk to 

human health at the beach. So I agree with the comment that Bob 

made about the tradeoffs if you mandate testing at this point for 

all these different types of pharmaceuticals. 

Senator VITTER. OK. Thank you. 

Senator BOXER. Well, I don’t know if a day at the beach has anything to do with all of this. You just throw up straw men. Your job 

is to protect human health at the beach, at the drinking water tap. 

It is not one or the other. That is the problem. 

I agree with you, Dr. Hirsch, to be prudent is key here. And to 

be prudent is to protect our children and our pregnant women and 

228 

to do the work that is necessary. This Administration has not followed the law, and in your own admission, haven’t listed anything. 

Now, just for the record, you don’t need to know every detail and 

every answer before you decide to list certain of these unregulated 

contaminants so that people know what they are drinking. And 

sadly, you could sit here when the Associated Press did your work, 

the Associated Press did your work, and your work, and they are 

telling us what is in the water. And Dr. Hirsch said, well, it is really, we do need to know what is present before we can do anything 

else. Yes, let’s find it out. 

Well, you find it. You said it’s important in your own testimony. 

And yes, if you think this is important and you are concerned, then 

we need to have some of this testing to find out. 

Now, has EPA, Mr. Grumbles, required drinking water systems 

to monitor drinking water for any pharmaceuticals, not 70, not 80, 

maybe some of the ones we know are more present in the water? 

Have you required drinking water systems to monitor drinking 

water for even one pharmaceutical through the agency’s unregulated contaminant monitoring rules? Have you done that? 

Mr. GRUMBLES. Not yet. 

Senator BOXER. You haven’t done it. Do you plan to do it? 

Mr. GRUMBLES. We may. We are seriously considering that. 

Senator BOXER. When are you going to do that? 

Mr. GRUMBLES. Well, Madam Chair, I don’t know because we 

need to gather more information on that, but we are taking that 

very seriously. 

Senator BOXER. I am glad you are taking it seriously, but I don’t 

see anything happening. I don’t. I don’t see it. You are cutting a 

program 35 percent. Your program was also cut 12 percent. It is 

unbelievable to me, Mr. Chairman, what is going on. 

Mr. Grumbles, your testimony states, ‘‘Useful information should 

be shared with the public in a timely way as it is generated. It is 

important to communicate with the public so that they can help 

shape effective public policy in this area and make informed 

choices.’’ Are you saying with all those words that the public has 

a right to know when pharmaceuticals have been found in their 

drinking water? 

Mr. GRUMBLES. If you mean ‘‘right to know’’ in terms of a defined 

term of art under some statute, I don’t know what that means. 

Senator BOXER. You don’t know what I mean by the public’s 

right to know what is in their water? You don’t understand? 

Mr. GRUMBLES. I don’t know if you are meaning to say under 

EPCRA or some other specific statute. 

Senator BOXER. I am asking you, be a person, be a human, throw 

away the bureaucratic hat that you have had on for a lot of this. 

As a human being, I don’t know whether you are a dad or uncle 

or whatever your circumstances. I am a grandma and a ma. Do you 

think our families have a right to know what is in their drinking 

water? 

Mr. GRUMBLES. I agree with that completely. The quarterly reporting requirements under the Safe Drinking Water Act about 

contaminants is very important. 

Senator BOXER. Good. Then get to work under the authorities 

you have and let’s start testing for those pharmaceuticals that the 

229 

Associated Press found were found in larger quantities in the 

water. 

Now, would you agree that water utilities and Federal agencies 

should publicly disclose test results when they know about pharmaceuticals or other contaminants in the drinking water? 

Mr. GRUMBLES. I think they should disclose information that is 

useful to the public. Are you asking that just any raw data they 

have that they don’t know what it means or if it is inaccurate or 

it hasn’t been QA/QC’d I don’t know. What I do know is that—— 

Senator BOXER. I said test results. In other words, what I am 

getting at it, you see, I believe the public is really smart. And I believe moms and dads really understand what it means to drink safe 

water and water that makes them sick. They get it. 

The White House is keeping their working group secret. You 

have done nothing under the law. I don’t mean you personally, but 

how long have you been in your position? 

Mr. GRUMBLES. Since November, 2004. 

Senator BOXER. OK. We haven’t moved forward on anything that 

we were supposed to on the Endocrine Disrupter Act, cutting funding instead. 

So I don’t want to keep on going here, but I guess I want to say 

to my Chairman of this very important Subcommittee and to his 

Ranking Member, it is the saddest of all things for me to see two 

people sitting here who are really smart, and to know that their 

work is being done by the Associated Press. There is something 

wrong in this Country when the Environmental Protection Agency 

can only sit here and say, well, yes, we made these budget cuts and 

we support them; we don’t think it matters; and gee, these are 

tough times, so if we are going to protect your beaches, Senator 

Lautenberg, we can’t really do everything we want in other areas. 

Unacceptable. That is not what the law requires of you. 

So I hope today, after seeing some of us being a little more upset 

than others here, that you will immediately go back, have a meeting with the FDA, get your act together, try to come up with some 

voluntary way to dispose of these so we don’t see this showing up 

in the drinking water. Let’s work together with this Committee. We 

are ready, willing and able to work with you on that. Let’s start 

listing some of these unregulated chemicals here so people know 

what they are drinking. 

You can do many, many things, and so far what I hear from you 

is, I am concerned; I am deeply concerned; it will take time; I will 

look it over. It is not enough for me. I hope that our Subcommittee 

Chair will call you back in a few weeks so we can see the progress 

that you have made. I look forward to getting the documents from 

the White House. 

Thank you. 

Senator LAUTENBERG. Thank you. 

We are joined by Senator Cardin, who wanted to make a statement. 

OPENING STATEMENT OF HON. BENJAMIN L. CARDIN, 

U.S. SENATOR FROM THE STATE OF MARYLAND 

Senator CARDIN. Very briefly, Mr. Chairman, because I know you 

want to get on to the next panel. 

230 

Let me ask unanimous consent that my entire statement can be 

made part of the record. 

Senator LAUTENBERG. Without objection. 

[The prepared statement of Senator Cardin follows:] 

STATEMENT OF HON. BENJAMIN L. CARDIN, U.S. SENATOR

FROM THE STATE OF MARYLAND

Mister Chairman, thank you for holding this hearing today. 

While we have made considerable strides in cleaning up our Nation’s drinking 

water by significantly reducing large-scale sources of pollution, technological advances in our ability to monitor the concentrations of contaminants in our Nation’s 

waters have led to the some disturbing findings. 

Trace amounts of pharmaceuticals, insecticides, herbicides, cleaning products, as 

well as chemicals associated with perfume fragrances are being found in the drinking water supplies of at least 41 million Americans, according to an investigation 

by the Associated Press released last month. 

Although these chemicals are found at exceedingly low concentrations, typically 

less than one part in a billion, the bioaccumulative properties of some of the chemicals, suggest that over time, these chemicals may buildup in the tissue of aquatic 

wildlife and humans and pose health risks. As a consequence, even though these 

chemical concentrations may be sufficiently low to label the levels as ‘‘trace’’ 

amounts, the repercussions of these compounds on long-term human health remain 

unclear. 

Federal officials continue to investigate the effects on human health of the endocrine disruptors found in water. The effects of these pharmaceutical compounds include possible links to neurological problems in children and increased incidence of 

some cancers. U.S.G.S. scientists are investigating a wide range of fish health problems in Chesapeake Bay and its watershed. 

The Potomac River, which serves as the source of drinking water for millions of 

people who live, work and visit the National Capitol Region, has had serious problems with fish health in recent years. Several studies of the Potomac and Shenandoah rivers, including those by scientists of the USGS, have revealed inter-sex 

fish, a wide range of ‘‘abnormalities in which both male and female characteristics 

are present within the same fish.’’ 

According to an August 2007 E-magazine article, the abnormalities include nine 

male smallmouth bass from the upstream Potomac River from Washington near 

Sharpsburg, Maryland that developed female eggs inside their sex organs. Inter-sex 

bass were also found in a study 3 years earlier, after fish kills about 170 miles upstream in the South Branch of the Potomac in Hardy County, West Virginia. The 

USGS has recently documented the occurrences of these disorders, but its research 

is in its infancy. 

In addition to the examination of samples of fish physical anomalies and fish tissue condition, the USGS is also sampling water chemistry and sediments within the 

rivers from which the fish samples have been taken. The chemistry includes evaluating concentrations of hormones, pharmaceuticals, personal care products, and pesticides. The concentrations of various chemicals and chemical mixtures may help explain the fish conditions found in the Potomac. Finding the causes of the fish health 

conditions and what various species of fish respond to, is a complex problem and 

will take some years to address adequately. 

The urgency of the situation was noted by the EPA’s director of America’s water 

programs, Ben Grumbles, who said, ‘‘We recognize it is a growing concern, and we’re 

taking it very seriously.’’ 

But the Bush administration budget does not reflect that level of seriousness. 

Under the President’s fiscal year budget request, EPA’s budget for Science and 

Technology faces a cut. In fact, when adjusted for inflation, EPA’s R&D funding 

would fall to the lowest level in more than two decades in real terms. And EPA’s 

budget cuts are not alone. 

The U.S. Geological Survey, who has as part of its mission to provide water information that benefits the Nation’s citizens, is also facing major budget cuts. 

The USGS Programs that are primarily responsible for providing chemical data 

to help explain fish conditions are the Toxic Substances Hydrology Program, and the 

National Water Quality Assessment Program. These two water quality programs 

are both scheduled for substantial funding reductions or redirections in fiscal year 

2009. 

Specifically, the USGS National Water-Quality Assessment program will be cut by 

nearly $11 million. (-$10.9 million)—The 2009 budget request for the National 

231 

Water-Quality Assessment (NAWQA) program is $54.1 million and 328 FTE, a program decrease of $10.9 million and 72 FTE from 2008 enacted. The Toxic Substances Hydrology program is slashed by $2.8 million in the President’s budget request. That represents a 21 percent reduction in critical funding at 

a time when our needs are obviously great. My amendment to the Budget Resolution for fiscal year 9, which Madame Chairman co-sponsored, increased funding for 

this important research work to move forward. 

I look forward to learning more about this serious problem. I hope to hear testimony that explains why the President’s budget priorities do not match with the apparent urgency of this problem. I further want to learn what studies are necessary 

to better understand the impact of these trace chemicals on not only aquatic life, 

but humans as well—more specifically, ‘‘Who is at greatest potential risk?’’ and ‘‘Is 

there a coordinated effort between USGS and EPA with HHS to relate the fish abnormalities and chemical concentrations to human impacts?’’ Finally I’d like to better understand what are the most effective steps citizens, local water treatment facilities, and the Federal Government can do to ensure that our drinking water is 

free of potentially harmful ‘‘trace’’ levels of herbicides, insecticides, hormones, and 

pharmaceuticals. 

Thank you Mister Chairman. 

Senator CARDIN. Let me make an observation. That observation 

is following up on Senator Boxer’s comments. We have a responsibility to make sure that we do everything to keep people safe. I 

look at this water that I am about to drink, and I have confidence 

that it is safe, but I think there are certain questions that should 

have been answered that have not been answered about how this 

water has been inspected to make sure that the contaminants that 

have been reported are not adversely affecting our health. We don’t 

have the answers to these questions and that is what concerns me. 

I live in this area. The Chesapeake Bay is very important. The 

Potomac River serves as the source of drinking water for millions 

of people in this region. The USGS studies have shown that fish 

in the Potomac and the Shenandoah suffer from abnormalities that 

could be linked to the types of pollutants that we are talking about, 

even though they are in small quantities. We see a single fish that 

has the attributes of both sexes. We are not exactly sure why that 

is happening, but it would be good to have more focus on trying to 

answer these questions. 

So Mr. Chairman, I thank you very much for holding this hearing. During the appropriation process, you and I both serve on the 

Budget Committee, I offered an amendment, and I am proud to 

have the support of my colleagues here, to increase the funding so 

that we can provide the money necessary to do the studies as our 

responsibility. 

I just hope we would have a sense of urgency, to be able to answer questions that are being posed by our constituents, reasonable 

questions as to whether these traces of contaminants that have 

been discovered from pharmaceutical products and other types of 

products, whether they have a risk factor and whether we understand that, and whether we have done the right testing to make 

sure that we have done everything possible to keep them safe. That 

should be our responsibility and I would urge this Committee to 

continue its oversight role and insist that the appropriate studies 

are done. We certainly are making the resources available. Let’s 

make sure the agency provides the answer. 

With that, Mr. Chairman, I thank you for your patience. 

Senator LAUTENBERG. Thanks very much. 

We thank you for your testimony. This record will be kept open 

for probably a week or two so that we can submit questions and 

232 

ask that you respond as promptly as you can. Thank you very 

much for your testimony. 

And now we call the second panel finally to the desk. We apologize for being so long in getting to you, but we had great interest 

in the subject, and it is obvious by the questions that were asked. 

Thank you all for being here. The fact that we are so tardy in 

getting to you doesn’t indicate a lack of interest and the fact that 

I am the Chairman and only member of the Committee at this moment. We appreciate the work that you have done in preparing 

your testimony. I would ask that you try to limit it to 5 minutes 

if you can. 

Dr. Sass, you are the first in line. We call on you. Thank you for 

being here. 

STATEMENT OF JENNIFER SASS, SENIOR SCIENTIST, 

NATURAL RESOURCES DEFENSE COUNCIL 

Ms. SASS. Thank you. Good afternoon and thank you for the opportunity to testify on the health concerns and policy proposals addressing pharmaceuticals in the Nation’s waterways and drinking 

water sources. 

I am Jennifer Sass, a Senior Scientist in the Health Program at 

the Natural Resources Defense Council. I have a doctorate degree 

in molecular and developmental biology and a post-doctoral certificate in environmental toxicology. I have worked at NRDC on a environmental health issues for over 7 years. 

As this Committee is aware, the Associated Press recently reported on the presence of pharmaceuticals, including antibiotics, 

anti-convulsants, anti-depressants, steroids and reproductive hormones in the drinking water serving millions of people. Although 

the levels reported to contaminate our waterways are much lower 

than therapeutic doses, it would be naive to think of them as safe, 

knowing that the agents are chemically reactive in our bodies and 

that we are exposed daily over a full lifetime to multiple compounds in unknown combinations. 

When a medical professional prescribes a drug, they consider the 

patient’s health status, age, gender, nutritional status, and any 

other drugs that may cross-react. For example, a pregnant woman 

would not knowingly expose her fetus to chemicals that cause birth 

defects such as anti-seizure drugs. A doctor would not knowingly 

prescribe toxic chemotherapy agents to a healthy person. And yet 

all these things and more are in our Nation’s drinking water. 

Pharmaceuticals and personal care products end up in the environment through waste from human or animal excretion, improper 

disposal such as flushing down a toilet, or leaching from municipal 

landfills. However they get there, they are contaminating our waterways and tap water. 

There are two categories of pharmaceuticals that raise particular 

concern to us: antibiotics and endocrine-or hormone-disrupting 

chemicals. Large animal feeding operations generate a large 

amount of antibiotic-contaminated waste that enters waterways 

and contributes to antibiotic-resistant pathogens. This means that 

when a person gets sick, the antibiotic that their doctor may reach 

for may not work. 

233 

The traditional toxicology dogma has been the dose makes the 

poison. But for endocrine-or hormone-disrupting chemicals, the timing of the exposure may be much more important than the dose. 

Exposures to endocrine-disrupting chemicals during critical windows of development such as infancy and adolescence have been 

shown to have permanent effects. Some of these effects such as infertility or cancer may not arise until adulthood, even though the 

exposure occurred during early life. 

For example, pre-birth exposure to DES, diethylstilbestrol, increased cancer risk for the daughters born to mothers that took it 

during pregnancy. Yet since pharmaceuticals that mimic estrogens 

are excreted as waste by-products from the use of birth control 

pills, menopause treatments and cancer therapies, they end up in 

our drinking water. 

Endocrine-disrupting steroids used in livestock operations also 

contribute to widespread environmental contamination. The U.S. 

Geological Survey found a high incidence of intersex fish in the Potomac watershed, and it was associated with sites of intense farming and high human population density. Male smallmouth bass in 

those areas had eggs in their testes. 

Despite the various safeguards that EPA could have taken to develop a robust picture of the problem, the agency has taken advantage of none. For example, the Safe Drinking Water Act requires 

EPA every 5 years to publish a list of currently unregulated contaminants that should be considered for potential regulation. For 

these lists, EPA has identified 130 potential chemicals, and none 

are pharmaceuticals or personal care products. 

Since 1999, EPA has required community water systems to monitor for a list of unregulated contaminants. That list contains no 

pharmaceuticals. The Safe Drinking Water Act requires community 

water systems to mail each of their customers an annual report on 

the level of contaminants in the drinking water that they supply. 

EPA has not required utilities to inform their customers when 

pharmaceuticals or personal care products are found. 

And Congress mandated EPA to address endocrine-disrupting 

chemicals in drinking water. It has not been 12 years since this 

mandate, and the endocrine disrupter screening program has not 

yet tested its first chemical. 

In addition to addressing the above failures, we need to address 

the unnecessary use of antibiotics and steroid hormones to tackle 

the problem at its source. We need to invest in our wastewater and 

drinking water infrastructures and find ways to monitor and treat 

for chemical contaminants that present the biggest health risks. 

We must also continue to reduce the amount of toxic chemicals 

used in products and promote the development and use of safer alternatives. 

Thank you for inviting me to testify before you today. NRDC 

looks forward to working with the Committee and Subcommittee to 

address these important issues, and I would be happy to answer 

any questions. 

[The prepared statement of Ms. Sass follows:] 

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Senator LAUTENBERG. Thank you, Dr. Sass. 

Dr. Goldhammer, we are pleased to have you here, the Deputy 

Vice President of Regulatory Affairs for the Pharmaceutical Industry Association, also known as PhRMA. Welcome. 

STATEMENT OF ALAN GOLDHAMMER, DEPUTY VICE PRESIDENT, REGULATORY AFFAIRS, PHARMACEUTICAL RESEARCH AND MANUFACTURERS ASSOCIATION 

Mr. GOLDHAMMER. Thank you very much, Mr. Chairman. 

Today, my focus will be on four key areas: where do these trace 

amount of pharmaceuticals come from; is there any impact on 

human health; do they have any impact on aquatic life; and the activities or pharmaceuticals in the environment, or as we call it, the 

PIE Task Force. 

Pharmaceuticals are found in the environment primarily because 

trace amounts of medicines pass through the human body without 

being completely metabolized. They make their way through to surface waters, through municipal wastewater treatment systems. 

These concentrations of pharmaceuticals in the environment are 

extremely low. In fact, we probably would not be here today were 

it not for the development of improved analytical testing permitting 

the detection of these trace amounts in surface waters. The concentrations of pharmaceuticals in drinking water are generally at 

trace levels in the parts-per-trillion range. To put this in context, 

one part-per-trillion is about one penny in $10 billion. On average, 

the pharmaceuticals detected in U.S. drinking water are present at 

only 18 parts-per-trillion. 

It is currently not possible to prevent medicines from entering 

the environment. Wastewater treatment plants were designed to 

mimic natural biodegradation process and to reduce, not eliminate, 

pollutants present in domestic wastewater. Compounds including 

pharmaceuticals, consumer products and household cleaning agents 

are expected to be present at trace amount levels in discharges 

from wastewater treatment plants. 

Pharmaceuticals are rigorously tested prior to their approval by 

regulatory agencies. Numerous years are spent studying their efficacy and safety in animal studies and directly in human clinical 

trials. As part of this effort, the time course of absorption into the 

body, metabolism, and ultimately excretion are measured. 

Unmetabolized medicine and their byproducts that are excreted 

find their way into the environment. 

Scientific studies from several countries, including the United 

States, conducted to date suggest that these small quantities of 

pharmaceuticals are unlikely to be harmful to human health. For 

example, dietary exposure to hormones such as the estrogen that 

naturally occurs in milk and soy products is much higher than the 

exposure to residues of any estrogen-like pharmaceutical in water. 

Trace levels of antibiotics found in surface waters are far below 

concentrations necessary to develop antibiotic resistance in microbes. 

Even though much research has been done over the past decade, 

there are still understandable questions raised by the public about 

possible impacts from the presence of these molecules. PhRMA and 

its member companies are committed to working with experts to 

260 

openly consider and help answer these questions. We believe that 

environmental impacts are already addressed through current regulations. An environmental assessment or EA is part of the drug 

registration process to evaluate the potential for environmental impacts of a human pharmaceutical. Substances entering the environment at less than one part-per-billion are typically excluded, although an EA for these substances based on extraordinary circumstances may be required. Data on environmental fate, transport, and potential effects may be developed and submitted as part 

of this regulatory process. 

While there is speculation that the potential might exist for 

pharmaceuticals to impact wildlife, the scientific community believes that pharmaceuticals will not result in short-term toxicity. 

This consensus is based on the documented low concentrations of 

pharmaceuticals in the environment and a substantial quantity of 

acute toxicity data. PhRMA supports this view. 

The mere presence of a substance in water does not mean harm 

will result. The critical factors are the concentration present in the 

water and whether that concentration is a high enough level to 

cause an effect. If the concentration is not high enough, that compound is simply likely to be a part of the vast background of chemicals both natural and synthetic present in natural environments 

such as soil and water. 

PhRMA is committed to understand the environmental significance of trace concentration of pharmaceuticals in the environment. 

We developed the PhATE model to predict concentration of pharmaceuticals in a variety of water sources. This model is now being 

used by researchers in Korea, Japan and Canada to predict environmental concentrations of pharmaceuticals in the surface water 

of those countries. Representatives from our PIE Task Force have 

published dozens of articles in the peer-reviewed scientific literature evaluating the fate and effects of pharmaceuticals in the 

environment. 

We developed the PhACT data base to summarize all published 

English-language peer-reviewed literature about the effects of 

pharmaceuticals on aquatic life, as well as treatment data for pharmaceuticals in wastewater and drinking water. Our representatives 

have participated in and led numerous scientific conferences over 

the past 5 years. 

Although a minor contributor to the environment, unused medicines that are flushed down toilets or poured down sinks can find 

their way into the environment. In March, 2008, PhRMA joined the 

American Pharmacist Association and the U.S. Fish and Wildlife 

Service in launching the SMARxT Disposal Program aimed at educating the public about not flushing or pouring any unused medicines down the drain. This program is designed to raise public 

awareness and promote the proper disposal of unused medicines. 

PhRMA remains committed to the ongoing study of trace 

amounts of prescription pharmaceuticals in the environment. Our 

PIE Task Force will continue to work with interested stakeholders 

to explore the scientific issues associated with pharmaceuticals in 

the environment, and we will also partner with interested parties 

to better communicate the message about responsible disposal of 

unused medicines. 

261 

As the available science demonstrates and PhRMA concurs with, 

trace amounts of pharmaceuticals in the environment are unlikely 

to pose any human health or environmental risks. 

[The prepared statement of Mr. Goldhammer follows:] 

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Senator LAUTENBERG. Thank you very much. 

We are fascinated by the volume of important data that the two 

of you have put into a relatively short timeframe, so we appreciate 

that. 

Dr. Snyder, the Research and Development Project Manager at 

the South Nevada Water Authority. We welcome you, sir. 

STATEMENT OF SHANE SNYDER, R&D PROJECT MANAGER, APPLIED RESEARCH AND DEVELOPMENT CENTER, SOUTHERN 

NEVADA WATER AUTHORITY 

Mr. SNYDER. Good afternoon. My name is Dr. Shane Snyder, and 

I am the Research and Development Project Manager for the 

Southern Nevada Water Authority. 

I am appearing today on behalf of the American Water Works 

Association, the AWWA, whose membership provides drinking 

water to more than 80 percent of the American people. We commend this Committee for its concern over our Nation’s drinking 

water, and I appreciate the opening comments. Clearly, we share 

a common objective, which is to ensure that Americans continue to 

have safe and sustainable drinking water. 

Personally, I have conducted research related to trace pharmaceuticals in water for more than a decade, and have served as the 

principal investigator for numerous research projects related to 

pharmaceuticals in U.S. water supplies. My work in this field has 

been transparent, and I have authored more than 50 peer-reviewed 

scientific publications related to trace contaminants in water during my career. I presented the findings of my study at more than 

20 venues in the past year alone. 

I would like to make it perfectly clear that I am a scientists. I 

am not a policymaker. My intent today is to provide you with an 

objective scientific perspective and offer my professional insight regarding pharmaceuticals in water. 

Contrary to recent stories that characterize pharmaceuticals in 

water as an entirely new issue, pharmaceuticals were first reported 

in U.S. waters by the EPA more than 30 years ago. Since that pioneering effort, pharmaceuticals have been detected at diminishingly minute concentrations. This is not simply due to greater contamination of our Nation’s water supplies. This is a reflection of 

improved sensitivity and modern analytical technology. 

My research team has analyzed hundreds of water samples from 

across the United States only through the voluntary effort of this 

Nation’s water utilities. While it is true that we detected some 

pharmaceuticals in U.S. drinking waters, it is important that we 

place these concentrations into perceivable contexts. Consider that 

the highest concentration of any pharmaceutical my team detected 

in U.S. drinking water and placed in terms of time would be equivalent to 1 second in 750 years, in distance, a half-inch from the 

Earth’s surface to the moon. That is the highest concentration we 

detected. 

Now, I am not providing this analogy to dilute the importance of 

this issue, not at all. Nor am I implying that these levels are safe 

or unsafe. But it is difficult for all of us, myself included, to perceive nanograms per liter. To illustrate this point further, consider 

this: If my studies had been constrained by the ability to find pharVerDate Aug 31 2005 14:44 Sep 24, 2014 Jkt 000000 PO 00000 Frm 00277 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\85529.TXT VERN
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maceuticals in drinking water at parts-per-billion levels instead of 

parts-per-trillion, we would not have detected one pharmaceutical 

in any of our studies. 

Given the powerful analytical tools today, it is certain that all 

water on Earth will have detectable levels of some unregulated contaminants. This raises a critical question: Are we going to make decisions about monitoring and treatment based on our ability to find 

contaminants, or based upon the protection of public health? Again, 

I am not a policymaker. However, I can tell you with absolute certainty that if we regulate contaminants solely upon detection, we 

are embarking on a futile journey without end. 

The reason is simple. Over the past several decades, analytical 

methodology has evolved from detection limits at parts-per-million 

to today’s method detection limits in parts-per-trillion, to tomorrow’s parts-per-quadrillion. We already have laboratories that can 

measure things in parts-per-quadrillion. That is about 1 second in 

several million years. 

Utilities must have meaningful numerical targets for monitoring 

and treatment that are based upon the protection of human health. 

The detection of pharmaceuticals alone does not imply risk. Just as 

one cannot assume safety if they are not detected. It is of paramount importance that we consider the topic of pharmaceuticals in 

drinking water holistically. From the limited evaluation that my 

team has made, it does not appear that any of the trace pharmaceuticals we have detected in drinking water pose a risk to human 

health. However, our study is simply the beginning. 

My team has also evaluated conventional and advanced water 

treatment technologies in relation to removing pharmaceuticals 

from water. Clearly, some technologies are better than others. 

However, I urge you to consider all the costs, including environmental impacts from increased energy consumption, greenhouse 

gas emissions, and waste and byproduct issues that follow these 

advanced processes. 

If we should embark into treatment, it is clear that the treatment before release into the environment makes the most sense to 

protect both the environment and the public health. We encourage 

more studies related to health effects and further studies toward 

the development and implementation of sustainable technology to 

treat water. 

Again, I commend this Committee for your sincere concern regarding pharmaceuticals in U.S. drinking waters. I look forward to 

your questions and comments, and I invite you to contact myself 

and the AWWA for more information. We are certain that only by 

working together in a cohesive and collaborative manner can we 

continue to lead the world in providing our citizens with safe and 

sustainable drinking water. 

Thank you. 

[The prepared statement of Mr. Snyder follows:] 

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LAUTENBERG. Thank you very much, Dr. Snyder. 

Now, we have an opportunity to hear from a fellow New 

Jerseyan who is here as a witness. David Pringle has been very active on environmental issues in New Jersey, and helped my State 

lead the way on protecting the environment. We welcome you here, 

Mr. Pringle, as I use the formality here, but welcome David. It is 

nice to see you. 

STATEMENT OF DAVID PRINGLE, CAMPAIGN DIRECTOR, NEW 

JERSEY ENVIRONMENTAL FEDERATION 

Mr. PRINGLE. Thank you. I am David Pringle, Campaign Director 

for the Garden State Chapter of Clean Water Action. Our primary 

focus nationally is on water policy and has been since our founding. 

I am also the State Assembly Speaker’s appointee to the Drinking 

Water Quality Institute in New Jersey that sets drinking water 

standards, and I chair the Public Health Committee. 

New Jerseyans, more than most because of our population density, literally live on top of and right next to our drinking water. 

As a result, we face more risks in terms of supply shortages, even 

though we have the kind of wet weather that parts out west do not, 

and we have contamination issues. 

You have my written testimony, and to avoid repetition I really 

want to focus on the parts of my testimony that have been less addressed today and that frankly I think are the most important, 

which is that the Nation’s current regulatory framework is not 

really set up to address this problem. I will also make some recommendations on how this Committee can help fix that situation. 

Common sense dictates it is not a good idea to drink somebody 

else’s medicine, but that is what we are doing today because of agricultural runoff, human waste, industrial discharge, and using 

manure as fertilizer. As a result, as we have heard, hundreds of 

different kinds of organic compounds are getting out into our waters. This is not just a drinking water issue. It is a Clean Water 

Act issue as well. Pharmaceuticals, while it is only part of the problem, is a big part of the problem because they are designed to be 

biologically active. And this isn’t just about human medication. A 

big part of this situation is the veterinary and agricultural aspects 

of it. 

New Jersey has been on the forefront of these issues. Because or 

our population density, we faced the problem sooner, but we have 

had a lot of great work done. USGS, the New Jersey office there, 

has led some of the work in documenting the occurrences there, in 

collaboration with our own State DEP, the Centers for Disease 

Control, and several of our State universities have done a lot of the 

documenting of the occurrence and improving the technology so 

that we can find these issues and study the health effects. 

One study alone documented 600 unregulated contaminants in 

the State’s water supplies. While the levels are relatively low, 

again, current conventional treatment doesn’t remove them. They 

are designed to be biologically active. We know very little about 

their health and ecological effects, yet field studies are already 

starting to document ecological impacts on a Noah’s ark of wildlife. 

The Nation’s regulatory framework is not set up to address this 

problem. It is too costly. It takes too long, and it looks at too narVerDate Aug 31 2005 14:44 Sep 24, 2014 Jkt 000000 PO 00000 Frm 00288 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\85529.TXT VERN
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row of the problems. This is going to get worse as we rightfully reuse water more, given the water wars we are seeing and as medical 

breakthroughs hopefully continue. So we really have to get on top 

of it. 

As Barker Hamill, the Director of the New Jersey Bureau of Safe 

Drinking Water said, there are thousands upon thousands of 

chemicals out there. Even adding one more substance to the regulatory list can be a lengthy, costly and frustrating process. 

I will give you one example. In Toms River, New Jersey, there 

is a probable cancer cluster there. The leading suspect is a contaminant that was found in the 1980’s at a Superfund site, a few 

feet from a drinking water supply. It wasn’t a priority pollutant. 

It wasn’t looked at or addressed under Superfund. Ten years later, 

they find it in the drinking water. Ten years after that, we are still 

reviewing it. We have spent over $5 million on this one contaminant. There is still no standard, yet we are re-treating the water 

anyway. That is just one contaminant, when there are hundreds 

out there. How much are we going to spend continuing this chemical by chemical, only looking at a very narrow field of health impacts without any coordination between various agencies? 

The FDA is regulating pharmaceuticals, but they are looking at 

it from an acute basis, not a chronic one. EPA isn’t even looking 

at that. The other programs have a variety of flaws in them. They 

are not looking at cumulative or synergistic effects. They are too 

focused on just carcinogenic effects. They are not looking enough at 

the most vulnerable populations, the sick, the elderly, the young, 

women of childbearing age. 

And our wastewater systems and our drinking water treatment 

plants are not set up to address this new-age type of contamination. The sewer systems were basically set up in the Victorian era, 

and the drinking water systems are more a function from the last 

70 years. We are not ready to handle the problem. 

So I implore the Committee to take this issue very seriously. I 

am very happy this hearing is happening today. We need to restore 

the $10 million in cuts from the Bush administration for NAWQA. 

There is a series of other smaller cuts on monitoring that are critical. The State revolving fund needs to be refinanced this year. 

This is a bipartisan issue. On this one, the House Democrats cut 

$250 million that hope this Committee will restore. 

I would like to just close by emphasizing one point. We really 

need to be preventive here. We need to take a precautionary approach because these chemicals are designed to be biologically active. I hope that we look to fund aggressively programs like we are 

doing in New Jersey. There are pilot projects where they are looking at activated carbon to reduce this, and also looking at when is 

the appropriate time to trigger this, to move away from chemical 

to chemical, and look more at a treatment technique-kind of situation where if you know you have a significant level of treated 

wastewater in your water supply or if you have an organic problem, that is a good indicator that you have other problems and we 

should be aggressive in treating them. 

Thank you. 

[The prepared statement of Mr. Pringle follows:] 

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Senator LAUTENBERG. I thank all of you for your comments and 

your contribution. 

One of the things that I find perplexing is the fact that I listened 

to Dr. Goldhammer with respect, and I wonder whether or not 

there is any risk because these are infinitesimally small amounts 

of trace chemicals. I think Dr. Snyder, you also said something 

similar. Do we dismiss it? 

Dr. Sass, I ask you, do you think the fact that there is—and I 

didn’t mean to start with you, Dr. Goldhammer, and leave you— 

but I want to execute this in a particular style, not any of you. 

[Laughter.] 

Senator LAUTENBERG. Dr. Sass, do you think that the fact that 

the quantities are so minute that worry can be put aside and say 

that it really doesn’t matter what is in the water, because there is 

so little of it—millions, billions. There was a quadri-that I heard 

introduced for the first time. What do you think, Dr. Sass? 

Ms. SASS. Well, we don’t have to guess at this. We know that 

many biological particles in the body normally act at those levels. 

The endocrine or hormone system is an example of one that is designed to act in these smaller than parts-per-trillion levels; immune system molecules and molecules that direct neural or brain 

development are active at these low levels. 

So what we need to do is understand what a fine and sensitive 

balance these systems are and make sure that we are not interfering with it. So we don’t have to guess whether compounds, even 

at those levels, could have an effect on human health. We know 

they could have an effect on human health. 

Your question is to understand what we know with certainty, 

and I think what we need to do is take a look at the animal data, 

take a look at the laboratory data and take a look at the wildlife 

data, and then use our intelligence to allocate our resources wisely, 

to prevent problems before they happen. 

We have a saying in science that if we wait for the epidemiology 

or we wait for the human evidence, then we are waiting for something to occur literally at epidemic proportions, and that is a failure of public health. 

Senator LAUTENBERG. Dr. Goldhammer, do we dismiss risk altogether because the fact that these quantities are trace amounts? Is 

it possible they don’t affect human health or animal health in any 

way to be concerned about? 

Mr. GOLDHAMMER. I don’t think we can ever say risk gets down 

to zero. I think we would be fooling ourselves to say that everything out there is with zero risk. I think in this case, though, we 

have with respect to human pharmaceuticals, a significant amount 

of data that gets submitted to the FDA with regard to what the 

dosage is that the doctor prescribes for the patient. That dose is orders of magnitude greater than what these trace amounts are that 

are found in the environment. 

We have a lot of toxicity data on these compounds from that 

work as well. The best available evidence today suggests that it is 

unlikely that these pose a human health risk and even an environmental risk. 

293 

I think as my statement made clear, though, that we do need to 

continue to work and study these issues. PhRMA stands ready to 

cooperate with our PIE Task Force in this regard. 

Senator LAUTENBERG. Let me ask you this, how about a fetus, 

embryonic stage. Is there more risk there in the development of a 

child, where suddenly—not suddenly becoming, that these things 

have reached a different proportionality in their occurrence—but is 

it better understanding of childhood auto-immune diseases, et 

cetera? Or are we to believe, for instance, that in the State of New 

Jersey, David Pringle, where it is now said that one in 94 male 

children will be born autistic. Now, that number has continued to 

increase. I watch these things very carefully. Is there danger to the 

health of a pregnant woman, the mother who is carrying that embryo? Do we say that all people are equal and it doesn’t matter 

what the amounts of pharmaceutical material, even including more 

than pharmaceuticals or was described as other chemicals? What 

about that? 

Mr. GOLDHAMMER. I think these are all good areas for further 

study. I think that work needs to be done across the board. It is 

not just a question of the burden of these very trace amounts of 

pharmaceuticals, but I think, as was noted by Dr. Snyder, if we 

want to go out with current technology and look for a given chemical, I think chances are very good it will be found in the environment at these parts-per-trillion or even lower amounts. 

The question we have to ask ourselves is—— 

Senator LAUTENBERG. But putting that aside, you know, accepting that as a condition of existence, Dr. Snyder you are referred to, 

what do you think about that? Could it affect, these minuscule 

amounts, could that have a different effect on an embryo or a 

mother carrying a child? Yes? 

Mr. SNYDER. Absolutely. We know that some of our population is 

more susceptible than others. This isn’t the field of which my study 

is involved. What I can say is that my concern would be that pharmaceuticals become more of a priority than chemicals we know 

have documented impacts to humans such as disinfection byproducts, which are in parts-per-billion. 

I concur that we need more research, and the utilities of this 

Country demand it. 

Senator LAUTENBERG. Well, I don’t want to make judgments on 

what you intended, Dr. Goldhammer, but is there any concern by 

the industry at all about these discharges into the water, however 

they get there? I mean, the fact is that we know that there are 

trace amounts of all kinds of things that are detectable in the 

water. Does the industry, even though they report regularly on the 

materials that they produce and that they put into the market, 

does the industry have any concern about the volume of these 

things that we might see, or the presence of these things that we 

might see in drinking water? 

Mr. GOLDHAMMER. No, I think it is fair to say we do have a concern. Our PIE Task Force was established over 10 years ago to exactly address that very point. Our data base of published papers 

in this area now runs over 1,200 papers. Our group meets on a 

very regular basis to look at the science. We are collaborating with 

294 

a number of external groups to try to advance the science in this 

area. We take our product stewardship extremely seriously. 

I think what we can say is from the available toxicity data that 

we generate during the course of all of our studies indicates at this 

point in time that there is unlikely to be a human health effect. 

Can I say it is zero? No, I can’t say it is zero. 

Senator LAUTENBERG. It is somewhere between unlikely and 

zero? Because it is obviously a matter of growing concern. As we 

know from other research that is being done, that there is an everincreasing presence of these materials in the water through whatever stream. 

David Pringle, we have New Jersey studies with utility companies who are looking at new treatment options. Have any of these 

pilot projects been so effective because even if here we don’t hear 

the alarm that many us feel, and I am one of those. I have 10 

grandchildren and I want them to be healthy and well. As a consequence, I want everybody’s grandchildren to be healthy and well 

because I just can’t select out mine. So I worry about these things. 

What do you see, Mr. Pringle? 

Mr. PRINGLE. We know that Victorian-era treatment technologies 

that we currently employ are not set up to address this problem. 

And so, it depends on how you look at the question. New Jersey 

is putting forward several different pilot projects. There are two 

that are in the design stages now that will be online this summer, 

one in Fair Lawn and the other in Pennsauken-Merchantville primary groundwater systems to put in granulated activated carbon 

to start looking at how effective it is at removing these kinds of 

compounds. Those two systems were picked because they have organic problems. We are just starting to work out some of the details—how often do you have to replace the filter, and what combination of treatment systems work, and those kind of things. 

The scientific literature is out there and we know that that kind 

of technology is much better than what we currently have on the 

ground. How effective, how expensive, when to use it, those are 

some of the questions we need to employ. 

But we also need to look at this as an opportunity to move away 

from yesterday’s generation and move to alternatives like fulfilling 

the vision of the Clean Water Act, which was ultimately a zero-percent discharge. Why do we use water as a vehicle to dispose of 

waste? Why aren’t we using more closed-loop systems? 

Senator LAUTENBERG. Well, I hate to answer that question, but 

convenience has overtaken us. I grew up in an industrial city in 

New Jersey, Patterson, New Jersey. Companies were invited to 

come there, establish their operations there so they could discharge 

their effluent into the river. Well, we have one big toxic river that 

we are now trying to clean up that runs through the city. 

I would ask any of you to respond. Can you think of any advantage that we obtain by cutting money for either State revolving 

funds or other research that EPA does? No one? What a surprise. 

Thank you all very much for your testimony. We will keep the 

record open and supply questions if necessary and ask that you respond quickly. 

With that, this hearing is concluded. Thank you. 

[Whereupon at 4:55 p.m., the subcommittee was adjourned.] 

295 

STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR

FROM THE STATE OF OKLAHOMA

Mr. Chairman, thank you for calling this hearing today on Pharmaceuticals in the 

Environment. I’m sure you would agree that Americans enjoy one of the safest 

drinking water supplies in the world, as well as reliable pharmaceutical drug supplies. Over the years, science has helped answer many questions and provide remarkable cures for common viruses to complex diseases. At the same time, science 

often creates many new and challenging questions. It has moved us to a point where 

we can now detect contaminants in our water all the way down to the parts per 

trillion. Those emerging contaminants have caused the public to rightly question, 

is our drinking water safe? I believe the answer is yes, as we will hear in testimony 

today. 

A few weeks ago, the Associated Press reported on emerging traces of pharmaceuticals in several municipal drinking water systems, spurring public concern and 

this hearing. Although, we should note that this is not a new issue. In fact, this 

subject has been studied for nearly 40 years, even before the Safe Drinking Water 

Act was signed into law. However, that doesn’t discount the public concern created 

over the media report. 

Mr. Chairman, I sent a letter to EPA requesting that they first respond to the 

public, ensuring their health and safety is not immediately at risk. I also asked that 

the Administrator convene an advisory committee or working group comprised of all 

relevant Federal agencies, interested public and industry to review the emerging 

scientific data and identify possible mitigation practices to reduce overall disposal 

of pharmaceuticals. I appreciate EPA’s timely response on both requests and am 

happy to know there is no immediate health risk. I am also happy to hear that the 

administration is currently reviewing cross jurisdictional guidelines to find a better 

way for drug disposal. I look forward to hearing from our government panel. 

We will also hear testimony today from Dr. Alan Goldhammer from Pharmaceutical Research and Manufacturers of America, or PhRMA, who has done extensive research on pharmaceuticals in the environment. PhRMA has developed a watershed-based model to estimate concentrations of active pharmaceutical ingredients 

discharged into surface waters through everyday consumption of medicines. 

Through that base model, industry, in cooperation with USGS, has further developed human health risk data on 26 active pharmaceutical ingredients. A significant 

amount of time and money between the Federal Government and private industry 

has produced favorable studies suggesting that the public is indeed safe. I appreciate the time and effort by all in this area. 

I’m also pleased to have Dr. Shane Snyder from Southern Nevada Water Authority here to discuss his research on both the concerns that were raised by the media, 

as well as whether current scientific findings warrant expensive treatment mandates. Dr. Snyder has published several manuscripts and book chapters on endocrine disrupters and pharmaceuticals in water and we are happy to have him here 

today. 

Before we get started, anytime we discuss issues surrounding drinking water, I 

must take the opportunity to remind the committee that we need to improve our 

nation’s drinking water facilities by reauthorizing the States Revolving Loan Fund 

programs, both drinking and waste water. This committee has the responsibility to 

ensure clean, safe, and affordable water for our country by providing the necessary 

resources to our states and local governments. 

I hope this hearing provides clarity to the status of public health and safety, while 

recognizing that current treatment facilities are already under enormous compliance 

pressure. 

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