[Senate Hearing 110-1247]
[From the U.S. Government Publishing Office]


                                                       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

                               __________


                               ----------
                         U.S. GOVERNMENT PRINTING OFFICE 

85-529 PDF                       WASHINGTON : 2014
------------------------------------------------------------------------
  For sale by the Superintendent of Documents, U.S. Government Printing 
  Office, Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; 
         DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, 
                       Washington, DC 20402-0001 


               COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                       ONE HUNDRED TENTH CONGRESS
                             SECOND SESSION

                  BARBARA BOXER, California, Chairman
MAX BAUCUS, Montana                  JAMES M. INHOFE, Oklahoma
JOSEPH I. LIEBERMAN, Connecticut     JOHN W. WARNER, Virginia
THOMAS R. CARPER, Delaware           GEORGE V. VOINOVICH, Ohio
HILLARY RODHAM CLINTON, New York     JOHNNY ISAKSON, Georgia
FRANK R. LAUTENBERG, New Jersey      DAVID VITTER, Louisiana
BENJAMIN L. CARDIN, Maryland         JOHN BARRASSO, Wyoming
BERNARD SANDERS, Vermont             LARRY E. CRAIG, Idaho
AMY KLOBUCHAR, Minnesota             LAMAR ALEXANDER, Tennessee
SHELDON WHITEHOUSE, Rhode Island     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         DAVID VITTER, Louisiana
AMY KLOBUCHAR, Minnesota             CHRISTOPHER S. BOND, Missouri
SHELDON WHITEHOUSE, Rhode Island     GEORGE V. VOINOVICH, Ohio
BARBARA BOXER, California, (ex       JAMES M. INHOFE, Oklahoma, (ex 
officio)                             officio)



                            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


  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 Agency 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:]

             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 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 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 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 non-controlled 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 take-backs 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, asking 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    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 regarding 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    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 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 number 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.
    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.
    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?
    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 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 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 
cutting-edge 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 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 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.
    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 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 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 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.
    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 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 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.
    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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    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 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.
    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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    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 pharmaceuticals 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    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 narrow of the problems. This is going to get worse as we 
rightfully re-use 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    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.
    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 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 ever-increasing 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.]

            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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                  
