[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
__________
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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
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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
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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:]
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Senator Lautenberg. I thank all of you for your comments
and your contribution.
One of the things that I find perplexing is the fact that I
listened to Dr. Goldhammer with respect, and I wonder whether
or not there is any risk because these are infinitesimally
small amounts of trace chemicals. I think Dr. Snyder, you also
said something similar. Do we dismiss it?
Dr. Sass, I ask you, do you think the fact that there is--
and I didn't mean to start with you, Dr. Goldhammer, and leave
you--but I want to execute this in a particular style, not any
of you.
[Laughter.]
Senator Lautenberg. Dr. Sass, do you think that the fact
that the quantities are so minute that worry can be put aside
and say that it really doesn't matter what is in the water,
because there is so little of it--millions, billions. There was
a quadri-that I heard introduced for the first time. What do
you think, Dr. Sass?
Ms. Sass. Well, we don't have to guess at this. We know
that many biological particles in the body normally act at
those levels. The endocrine or hormone system is an example of
one that is designed to act in these smaller than parts-per-
trillion levels; immune system molecules and molecules that
direct neural or brain development are active at these low
levels.
So what we need to do is understand what a fine and
sensitive balance these systems are and make sure that we are
not interfering with it. So we don't have to guess whether
compounds, even at those levels, could have an effect on human
health. We know they could have an effect on human health.
Your question is to understand what we know with certainty,
and I think what we need to do is take a look at the animal
data, take a look at the laboratory data and take a look at the
wildlife data, and then use our intelligence to allocate our
resources wisely, to prevent problems before they happen.
We have a saying in science that if we wait for the
epidemiology or we wait for the human evidence, then we are
waiting for something to occur literally at epidemic
proportions, and that is a failure of public health.
Senator Lautenberg. Dr. Goldhammer, do we dismiss risk
altogether because the fact that these quantities are trace
amounts? Is it possible they don't affect human health or
animal health in any way to be concerned about?
Mr. Goldhammer. I don't think we can ever say risk gets
down to zero. I think we would be fooling ourselves to say that
everything out there is with zero risk. I think in this case,
though, we have with respect to human pharmaceuticals, a
significant amount of data that gets submitted to the FDA with
regard to what the dosage is that the doctor prescribes for the
patient. That dose is orders of magnitude greater than what
these trace amounts are that are found in the environment.
We have a lot of toxicity data on these compounds from that
work as well. The best available evidence today suggests that
it is unlikely that these pose a human health risk and even an
environmental risk.
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.
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