# STATEMENT OF

DR. ROBERT M. HIRSCH

ASSOCIATE DIRECTOR FOR WATER

U.S. GEOLOGICAL SURVEY

### U.S. DEPARTMENT OF THE INTERIOR

BEFORE THE

## COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

SUBCOMMITTEE ON TRANSPORTATION SAFETY, INFRASTRUCTURE SECURITY AND WATER
QUALITY

April 15, 2008

Mr. Chairman and Members of the Subcommittee, thank you for the
opportunity to provide the views of the U.S. Geological Survey,
Department of the Interior, on pharmaceuticals in the environment. 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 waste
treatment technologies and best management practices that are most
effective at removing pharmaceuticals and other trace organic chemicals
from surface and ground waters and 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 new group of contaminants that enter the environment via
human and animal wastes. 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. In recent
years, they have been detected increasingly in the environment at very
low levels (less than one part per billion). Despite these extremely low
levels, investigation is warranted to determine if there are any
potential adverse environmental and human health effects. Research and
monitoring by the USGS and others have demonstrated that

\(1\) the manner in which we handle and dispose of our wastes can
concentrate these chemicals in some environmental settings to levels
that may be an ecological health concern, and

\(2\) pharmaceuticals have been entering the environment for as long as
we have used them.

In 1998, the USGS broadened its water-quality science programs by
initiating research on pharmaceuticals and other human- and animal-waste
related chemicals. We were spurred by the findings of European
colleagues, who, looking for a pesticide, detected a heart medication in
the North Sea (Buser et al., 1998). The realization that chemical-use
and waste-handling practices had resulted in detectable concentrations
of a drug in such a large water body suggested the need for further
research. By 2002, a USGS study (Kolpin et al., 2002; Barnes et al.,
2002; and Buxton and Kolpin, 2002) had documented the presence of
pharmaceuticals and other waste-associated chemicals in the Nation's
streams, and largely defined this issue in the United States.

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

-   Document the occurrence, concentration, and mixtures of these
    chemicals in various environmental compartments, including stream
    water, well water, stream sediment, and soil amended with manure and
    biosolids (the solid byproduct of wastewater treatment plants);

-   Demonstrate the comparative contributions from various sources,
    including wastewater treatment plants, livestock production and
    animal feedlot wastes, aquaculture, onsite septic systems, combined
    sewer overflows, and other industrial discharges; and

-   Demonstrate that some of these chemicals are assimilated by
    organisms (Kinney et al., 2008) or cause adverse ecological health
    effects (Vajda et al., 2008).

The bibliography of USGS reports that support these findings on
pharmaceuticals and other emerging contaminants in the environment is
available on the Internet at:
[*http://toxics.usgs.gov/bib/bib-Emerging.html*](http://toxics.usgs.gov/bib/bib-Emerging.html).

A recent example of USGS research is described in a series of reports on
the levels and mixtures of human- and animal-waste related chemicals
that are found in wastewaters, biosolids, and manures, and the soils to
which they are applied for fertilization, as well as the earthworms
found in those soils (Kinney et al., 2006a, 2006b, and 2008).

USGS investigations at a conventional drinking water treatment facility
in New Jersey described the changes in pharmaceutical concentrations
from the source water through multiple stages of the treatment process
(Stackelberg et al., 2004, 2007). Additional investigations like this
one will inform decisions on improving existing and developing new
treatment works that are more efficient at removing these compounds from
source waters (the sources of drinking water).

Two USGS papers, anticipated to be published in the coming weeks in the
peer-reviewed journal *Science of the Total Environment,* summarize the
occurrence of these chemicals in ground water (Barnes et al., in press)
and in raw (untreated) sources (streams and wells) of drinking water
(Focazio et al., in press). The paper surveying source waters includes
results from 74 sites near drinking water intakes in 25 states and
Puerto Rico. All data from these reports will be made available to the
public in accompanying data reports available on the USGS web site.

The ecological effects of some pharmaceuticals found in the environment
have been documented in scientific literature For example, it was not a
surprise when antibiotics, which are designed to act as antibacterials,
were found to have adverse effects on soil microorganisms at
environmentally relevant concentrations (Thiele-Bruhn and Beck, 2005).
Testing also has found that some pharmaceuticals do not cause adverse
effects on some organisms tested. In one study, three freshwater
invertebrates were exposed to an anticonvulsant drug commonly found in
the environment. Only one of the 3 species demonstrated an adverse
effect (Oetken et al., 2005). Furthermore, evidence suggests that
chemical mixtures can act collectively to cause adverse effects, even
when each component is below its individual effect level (Brian et al.,
2007). These are examples of an increasing body of scientific knowledge
on potential adverse health effects. Significant uncertainty remains
regarding the effects of long-term exposure to levels found in
environmental settings.

Endocrine disruption is one adverse health effect of concern because it
may occur as a result of exposure to very low levels of hormonally
active chemicals. One form of endocrine disruption observed in
environmental settings affects fish reproductive systems, where fish
have been found to be "feminized" by exposure to a range of chemicals
that act similar to the natural hormone estrogen. Some ways in which
feminization is observed in fish include: (1) elevation in the percent
of fish populations that are female, (2) changes in behavioral
characteristics, such as nesting behavior, or (3) the presence of male
fish with female characteristics, such as the presence of female egg
cells in testes or of a female egg protein in their blood. A recent
study (Kidd et al., 2007) demonstrated that the addition of
ethinylestradiol (one of the active ingredients in birth control pills)
at observed environmental concentrations to an experimental lake in
Canada caused feminization and near extinction of fathead minnows in the
lake.

A wide range of hormonally active chemicals can contribute to endocrine
disruption, including actual biogenic hormones, synthetic hormones
(pharmaceuticals, such as ethinylestradiol), and other chemicals that
mimic or block hormone function (including certain pesticides,
detergents, metals, and other industrial chemicals). These chemicals
have been found together in waters affected by human and animal wastes
and can occur together in various environmental settings. This
reinforces why these chemicals must be studied together and not as
separate classes of contaminants.

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. The USGS has collected information on the occurrence,
concentrations, and mixtures of pharmaceuticals and other waste-related
chemicals in source waters used for drinking water and, to a much more
limited extent, in finished (treated) drinking water. Information
provided to the Food and Drug Administration (FDA) as part of the drug
approval process can be useful in identifying more potent
pharmaceuticals as the target of future research on possible effects of
pharmaceuticals in the environment. However, whether or not there are
adverse human health effects from cumulative lifetime exposures to the
low concentrations and complex mixtures of pharmaceuticals found in the
environment remains a research priority, particularly the effects on
sensitive subpopulations such as children, women of child-bearing years,
the elderly, and people with suppressed immune systems.

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. About a
quarter of these sites were sampled in nationally-designed targeted
surveys implemented by the USGS to assess the occurrence of
pharmaceuticals across a wide range of environmental settings. The
majority of the 1,500 sites were sampled as parts of studies conducted
by the USGS in cooperation with State and local governments. These
cooperative studies were designed to provide information for local
resource managers on conditions in their area, and the findings are
available to the public.

California provides an example of an extensive State program. The USGS
California Water Science Center, in collaboration with the California
Water Boards, has designed and implemented the Groundwater Ambient
Monitoring and Assessment (GAMA) Project to assess the quality of
California\'s ground water. The Priority Basin Program, a part of GAMA,
will sample approximately 2,500 wells in about 120 ground-water basins
in California over an 8-year period (2004-2012). From May 2004 through
December 2007, we have sampled about 1,400 wells for a very large suite
of constituents, both natural and human-generated, including
pharmaceuticals. About 1,000 wells are being evaluated for the presence
of pharmaceuticals.

The USGS is continuing to conduct research on pharmaceuticals in the
environment. Our research priorities will continue to include assessing:

-   Chemical loads of various sources including wastewater treatment
    plants, Animal Feeding Operations, landfills, and other industrial
    facilities,

-   Ecological effects, including fish endocrine disruption in streams
    enriched with wastewaters and antimicrobial resistance in settings
    where antibiotics are released to the environment,

-   The occurrence of pharmaceuticals in waters that are the source of
    drinking water and, to a limited degree, in treated drinking water,
    and

-   The comparative performance of varying water and waste treatment
    processes to remove pharmaceuticals and other chemicals.

The USGS conducts research on pharmaceuticals in the environment with a
number of partner Federal agencies, including the U.S. Environmental
Protection Agency (USEPA), Centers for Disease Control and Prevention,
Fish and Wildlife Service, and National Oceanic and Atmospheric
Administration. The USGS, USEPA, and FDA co-chair the Federal
Interagency Work Group on Pharmaceuticals in the Environment, under the
auspices of the Committee on Environment and Natural Resources of the
National Science and Technology Council. The Work Group has further
increased coordination of Federal research. The USGS is working with our
partner Federal agencies, including the FDA, to prioritize
pharmaceuticals for environmental study.

Thousands of pharmaceuticals are used for human therapies and veterinary
purposes. The USGS is focusing environmental research on chemicals that
are more likely to be of environmental concern, to increase the
efficiency of research within the existing limited resources available.
Similarly, investigations of adverse health effects must consider the
actual levels and mixtures of chemicals that organisms are exposed to in
the environment. Results of USGS studies of environmental occurrence are
used by many scientists to guide both human and ecological
health-effects 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, and I will be pleased to answer
questions you and other Members might have.

**REFERENCES:**

Barnes KK, Kolpin DW, Meyer MT, Thurman EM, Furlong ET, Zaugg SD, and
Barber, LB, 2002, Water-quality data for pharmaceuticals, hormones, and
other organic wastewater contaminants in U.S. streams, 1999-2000: U.S.
Geological Survey Open-File Report 02-94.
<http://toxics.usgs.gov/pubs/OFR-02-94/>

Barnes KK, Kolpin DW, Furlong ET, Zaugg SD, Meyer MT, Barber LB, (in
press), A national reconnaissance for pharmaceuticals and other organic
wastewater contaminants in the United States: I) Ground water. *Science
of the Total Environment*

Brian JV, Harris CA, Scholze M, Kortenkamp A, Booy P, Lamoree M, Pojana
G, Jonkers N, Marcomini A, and Sumpter JP, 2007, Evidence of estrogenic
mixture effects on the reproductive performance of fish. *Environmental
Science and Technology,* *41*(1), 337-344.

Buser HR, Muller MD, Theobald N, 1998, Occurrence of the pharmaceutical
drug clofibric acid and the herbicide mecoprop in various Swiss lakes
and in the North Sea. *Environmental Science & Technology*, *32*,
188-192.

Buxton HT, and Kolpin DW, 2002, Pharmaceuticals, hormones, and other
organic wastewater contaminants in U.S. streams: U.S. Geological Survey
Fact Sheet FS-027-02, 2 p. <http://toxics.usgs.gov/pubs/FS-027-02/>

Focazio MJ, Kolpin DW, Barnes KK, Furlong ET, Meyer, MT, Zaugg, SD,
Barber, LB, Thurman, EM, (in press). A national reconnaissance for
pharmaceuticals and other organic wastewater contaminants in the United
States: II) Untreated drinking water sources. *Science of the Total
Environment*

Kidd KA, Blanchfield PJ, Mill KH, Palace VP, Evans RE, Lazorchak JM,
Flick RW, 2007, Collapse of a fish population after exposure to a
synthetic estrogen. *Proceedings of the National Academy of Sciences*,
*104*, 8897-8901.

Kinney CA, Furlong ET, Werner SL, Cahill JD, 2006a, Presence and
distribution of wastewater-derived pharmaceuticals in soil irrigated
with reclaimed water. *Environmental Toxicology and Chemistry*, *25*,
317-326.
<http://pubs.acs.org/cgi-bin/abstract.cgi/esthag/2008/42/i06/abs/es702304c.html>

Kinney CA, Furlong ET, Zaugg SD, Burkhardt MR, Werner SL, Cahill JD,
Jorgensen GR, 2006b, Survey of organic wastewater contaminants in
biosolids destined for land application. *Environmental Science &
Technology*, *40*, 7207-7215.
<http://www.setacjournals.org/perlserv/?request=get-abstract&doi=10.1897%2F05-187R.1>

Kinney CA, Furlong ET, Kolpin, DW, Burkhardt MR, Zaugg SD, Werner SL,
Bossio, JP, and Benotti, MJ, 2008, Bioaccumulation of pharmaceuticals
and other anthropogenic waste indicators in earthworms from agricultural
soil amended with biosolid or swine manure. *Environmental Science and
Technology*, *42* (6), 1863--1870.
<http://pubs.acs.org/cgi-bin/abstract.cgi/esthag/2006/40/i23/abs/es0603406.html>

Kolpin DW, Furlong ET, Meyer MT, Thurman EM, Zaugg SD, Barber LB, Buxton
HT, 2002, Pharmaceuticals, hormones, and other organic wastewater
contaminants in US streams, 1999-2000: A national reconnaissance.
*Environmental Science & Technology*, *36*, 1202-1211.
<http://pubs.acs.org/hotartcl/est/es011055j_rev.html>

Oetken M, Nentwig G, Loffler D, Ternes T, Oehlmann J, 2005, Effects of
pharmaceuticals on aquatic invertebrates. Part I. The antiepileptic drug
carbamazepine. *Archives of Environmental Contamination and Toxicology*
*49*, 353-361.

Stackelberg PE, Gibs J, Furlong ET, Meyer MT, Zaugg SD, and Lippincott
RL, 2007, Efficiency of conventional drinking-water-treatment processes
in removal of pharmaceuticals and other organic compounds. *Science of
the Total Environment*, v. 377, no. 2-3, p. 255-272.
<http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6V78-4NB2SFN-2&_user=696292&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000038819&_version=1&_urlVersion=0&_userid=696292&md5=782f1fc5e594b3d0e696dfd62bbf79fd>

Stackelberg PE, Furlong ET, Meyer MT, Zaugg SD, Henderson AK, and
Reissman DB, 2004, Persistence of pharmaceutical compounds and other
organic wastewater contaminants in a conventional
drinking-water-treatment plant. *Science of the Total Environment*, v.
329, no. 1-3, p. 99-113.

<http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6V78-4CC30H2-K&_user=696292&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000038819&_version=1&_urlVersion=0&_userid=696292&md5=efb0c0e5ad401e84e2a4511c9557f4cc>

Thiele-Bruhn S, and Beck I, 2005, Effects of sulfonamide and
tetracycline antibiotics on soil microbial activity and microbial
biomass. *Chemosphere*, vol. 59, pp. 4457-465.

Vajda, AM, Barber, LB, Gray, JL, Lopez, EM, Woodling, JD, and Norris,
DO, 2008, Reproductive disruption in fish downstream of an estrogenic
wastewater effluent: *Environmental Science & Technology* (published
on-line March 25, 2008).