[Pharmwaste] Fw: BNA on pharma mtg in vegas
greene.cynthia@epamail.epa.gov
greene.cynthia@epamail.epa.gov
Mon, 29 Aug 2005 08:35:12 -0400
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Report on Los Vegas conference
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No. 166 Page B-1
Monday, August 29, 2005
ISSN 1521-9402
Conference Report
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Water Pollution
New Approaches Urged to Limit Pollution
From Pharmaceuticals, Other Compounds
LAS VEGAS--Reducing pharmaceuticals and other
compounds that survive wastewater treatment and enter
the nation's streams, rivers, and surface waters will
likely require new regulatory approaches, including
changes to current hazardous waste laws, researchers
and regulators said at a conference Aug. 25.
An array of compounds, known as pharmaceuticals and
personal care products (PPCPs), are ubiquitous but
unregulated pollutants in U.S. waters, Environmental
Protection Agency officials said at the "Meeting on
Pharmaceuticals in the Environment." The three-day
meeting was sponsored by EPA at the agency's Las Vegas
laboratory.
The compounds began to draw wider interest from U.S.
researchers since the late 1990s, reflecting more
sensitive methods that detect trace levels of the
compounds in water at the parts-per-billion or even
parts-per-trillion level.
The regulatory and research challenges posed by PPCPs,
which include prescription and over-the-counter drugs
as well as fragrances, cosmetics, sunscreen,
veterinary drugs, and DEET insect repellent were the
focus of the conference.
Representatives from EPA, the Food and Drug
Administration, the Drug Enforcement Agency, the U.S.
Geological Survey, and the pharmaceutical industry
also outlined various regulatory challenges to
reducing the presence of pharmaceuticals and personal
care products in the environment.
Recommendations Offered
They and other conference participants offered
recommendations at the closing session Aug. 25,
including:
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Changes are needed to the Resource Conservation
and Recovery Act, which governs disposal of
industrial and bulk chemicals but has also been
applied to medical waste in health care
settings. Several speakers said Congress should
reconsider how provisions meant to ensure the
safe disposal of medical waste encourage the
flushing of pharmaceutical compounds in toilets
and drains for safety reasons. The RCRA
requirements, they said, hinder efforts by
consumers, hospitals, and other healthcare
operations to return unused drugs ultimately to
manufacturers or otherwise disposed away from
the wastewater stream.
(Embedded image moved to file: pic18588.gif)EPA
needs to develop regulatory guidance for
wastewater treatment plants on best treatment
technologies to attack many pharmaceuticals and
other compounds before the treated effluent is
returned to waterways. Researchers and EPA
officials agreed the agency needs to move
further along in developing accepted testing
methods for PPCPs. EPA's Office of Research and
Development has identified PPCPs as an emerging
issue and continues to support research on
detecting such compounds through its STAR grants
program, but agency officials said a coordinated
regulatory approach to such unregulated
compounds is probably years away, given strained
resources.
(Embedded image moved to file: pic06422.gif)The
Drug Enforcement Administration needs to change
current regulations, which bar the collection of
many controlled prescription drugs, including
painkillers. The "take-back" programs could
allow consumers to return unused, expired, or
poorly stored pharmaceuticals to manufacturers
for safe disposal, akin to the kinds of product
stewardship efforts already being run by
consumer electronics and other industries.
(Embedded image moved to file: pic24946.gif)Food
and Drug Administration regulations governing
the regulatory review of pharmaceuticals should
be revised to include a review of the
environmental effects of pharmaceuticals.
Currently, FDA does not typically require drug
manufacturers to conduct environmental
assessments when concentrations of the drug
entering the water are expected to fall below 1
part per billion.
(Embedded image moved to file: pic27506.gif)FDA
should also provide guidance that moves
consumers and health care professionals away
from the practice of flushing pharmaceuticals
and toward proper disposal, including
incineration, to take the products out of the
wastewater stream. The agency also should
consider whether certain regulations requiring
the safe disposal of pharmaceuticals in nursing
homes and other long-term care facilities
encourage the wide-scale flushing of such
medicines.
Potential Health Effects
EPA officials and various researchers said human
health effects from a lifetime of consuming low levels
of PPCPs in drinking water are unlikely, but they
cautioned that such research is in its infancy. The
compounds can be pulled into intake systems for public
water systems that pull from rivers and other sources
that contain treated wastewater.
Failed septic tanks and "straight piping" residential
systems that pipe waste directly to rivers also
contribute to the levels of PPCPs in waters,
researchers said.
Researchers speaking at the three-day conference said
it is not well-understood how the trace levels of such
"micro-contaminants," or the interaction of the
various compounds, might affect humans or the
environment. Traditionally, the epidemiological
studies conducted on pollutants during the past few
decades have never accounted for potential effects
from the additional exposures from such
micro-contaminants.
Thousands of PPCPs are probably carried into rivers,
streams, and surface waters given the thousands of
distinct ingredients used in tens of thousands of
personal care products and pharmaceuticals, EPA
researchers said. Christian Daughton, chief of EPA's
environmental chemistry branch at EPA's National
Exposure Research Laboratory, said Aug. 23 that
detailed research on the effects of such compounds
downstream from wastewater plants remains in its
infancy.
"A lot of the research has grown exponentially in the
last five years," Daughton said. But detailed
literature is lacking on how trace levels of most of
the compounds might affect fish and other organisms.
There is "vast literature" on the effects of
antibiotics and steroidal hormones on such organisms
because those have long been studied, "but primarily
for everything else, there is very little that is
known," he said.
"To give you an idea of the scope of the chemicals
involved, we're not just talking about human and
veterinary drugs available by prescriptions or over
the counter," Daughton said. Other PPCPs of concern
include new classes of diagnostic agents used in
medicine, fragrances, and inert ingredients used in
the formulation of consumer products, Daughton said.
Risk From Unregulated Pollutants
Daughton said scientists and regulators have focused
for the past 40 years on the risks of traditional
"priority" pollutants that may be either acutely toxic
or carcinogenic. But it is becoming increasingly
obvious that those regulated pollutants make up only a
small portion of chemicals that may contribute to the
overall risks for humans and the environment, Daughton
said.
Carcinogens and other "archetypal" pollutants
currently regulated "are only one piece of the risk
puzzle," Daughton said.
"What portion of the overall risk is contributed by
unregulated pollutants and can that risk be assessed
in a truly holistic manner without knowing the actual
exposure universe" humans may in fact be exposed to,
he said.
The known chemical "universe" comprises some 26
million organic and inorganic chemicals, and of those,
9 million are commercially available worldwide,
Daughton said. Of those 9 million, about 250,000 "are
inventoried or regulated worldwide," meaning only
about 3 percent of commercially available chemicals
are substantially tracked or regulated around the
globe, he said.
Reducing PPCP Levels
Others at the conference said more research was needed
to determine the cumulative ecological impacts of
PPCPs on fish and other aquatic organisms. Of
particular interest among the PPCP class of compounds
are chemicals known to disrupt or alter sexual
development in animals, as well as various plant and
animal steroids that can affect hormonal development.
Charlotte Smith, president of PharmEcology Associates,
which assists healthcare facilities in reducing and
managing pharmaceutical waste, said Aug. 24 that EPA
in particular needs to focus more attention on
encouraging the development of pharmaceutical
"take-back" programs that allow consumers to return
unused drugs to the manufacturer or other entity for
proper disposal.
Today, most consumers and even many health care
workers simply place such drugs in household trash,
where they are ultimately sent to landfills, Smith
said. Those compounds ultimately drain from the
landfills and join other compounds in the "leachate"
liquid that drains from trash to the bottom of
landfills, and some of the liquid goes either into
wastewater treatment or can leach into wells located
near the landfill, other researchers said.
Other consumers may dispose such pharmaceuticals in
sinks or toilets in an effort to protect them from
falling in the hands of children or harming others,
researchers said.
"The resources need to be committed for this effort
from all aspects of EPA," Smith said. "We need the
offices of water, solid waste; all these offices need
to be involved," she said.
The array of changes needed to clear the way for
large-scale take-back programs led much of the
discussion among researchers, industry
representatives, and other conference participants who
broke into small groups on Aug. 24 to recommend policy
changes.
Jan Baxter, an EPA Region 9 official, said at the
conclusion of the conference Aug. 25 that most
participants from her group "viewed take-back
[efforts] as the most promising approach" to reduce
levels of pharmaceuticals entering public sewers and
wastewater treatment plants.
The preferable approach would allow consumers to
return unused pharmaceuticals to pharmacies, Baxter
said.
Barriers to Take-Back Efforts
Vickie Seeger, of the Drug Enforcement
Administration's Office of Diversion Control, said
Aug. 24 that DEA regulations likely discourage such
take-back programs. Under the Controlled Substances
Act of 1970, DEA largely prevents the transfer and
thus potential misuse of many "controlled"
prescription drugs ranging from oxycontin and morphine
to steroids, Seeger said.
"The DEA can't allow you to take your drugs back just
anywhere," she said, and current DEA regulations would
prevent the collection and disposal of controlled
substances at community-sponsored collection sites
similar to those offered for hazardous waste, she
said. To comply with current law, such collections
would require the presence of law enforcement
officials to take possession and maintain precise
records of the volume and type of each controlled
substance returned, she said.
"It's not that we don't want take-back [efforts],
we're not completely against it," Seeger said. "But we
don't have a regulatory system" that allows for
consumers to participate in such efforts, she said.
Al Alwan, an EPA official from Region 5, also led a
small group of other participants in a discussion on
possible policy recommendations. He said Aug. 25 that
any policy changes at EPA, including more regulatory
interest in PPCPs, will take time, given that research
on the health effects from exposure to the trace
compounds is in its earliest stages.
The low levels of contaminants detected suggests EPA
should take a cautious approach on regulatory action
until more research is conducted and the agency and
other researchers develop agreed-upon monitoring and
detection methods, he said.
"This is a long-term [issue] not an emergency issue"
for EPA regulators, Alwan said. Researchers do not
currently have a range of tools for measuring the
impacts from exposure to such trace levels of
compounds over a lifetime for humans or for organisms
in the environment, he said.
Alwan, who also led a smaller group of participants in
a policy discussion Aug. 24, said his group agreed
that the lack of an EPA-approved chemistry method to
address such chemicals is a major obstacle to
conducting research that can be compared from lab to
lab.
Alwan said the agency also needs to work with
wastewater treatment operations, pharmaceutical
manufacturers, and other groups to begin conducting
monitoring of the compounds to determine the universe
of PCCPs that may exist in various downstream areas.
"For monitoring, we [at EPA] really don't monitor
these new chemicals. We basically monitor the
chemicals that are regulated and really the states are
doing most of that monitoring" of specific listed
contaminants that may affect water quality, he said.
Reducing Disposal Routes in Wastewater
Researchers at the conference said, however, that
there were several issues regarding the compounds
about which there is general agreement, including the
source of most of the pharmaceuticals.
The disposal of over-the-counter and prescription
drugs into drains and toilets is probably only a small
part of the problem, researchers said, because most
PPCPs enter the wastewater system because they are
washed off during bathing or excreted by the human
body into drains and collected by sewer systems.
"Patient use is still the primary pathway by which
pharmaceutical compounds enter the environment," Mary
Buzby, a representative from the Pharmaceutical
Research and Manufacturers of America, said at the
conference Aug. 24.
Many pharmaceuticals, researchers said, are only
partially metabolized by humans before the compounds
are swept into sewage systems. The compounds often
survive the biodegradation process of wastewater
treatment and thus are passed downstream, where they
could impact waterborne organisms and can be drawn
into water treatment intake pipes for drinking water.
Existing Research Detailed
Mike Myer, a researcher with the U.S. Geological
Survey, said researchers are in the earliest stages of
developing analytical methods for assessing the
environmental fate and transport of PPCPs. There are
still only a few such methods that can detect such
compounds at such low concentrations, he said,
including several approaches used for USGS research
that focus on such chemicals in water, soil and
sediment.
USGS researchers since 2002 have developed specific
analytical methods for measuring a total of 158
compounds that have traveled through wastewater
treatment and are found downstream, Myer said. The
compounds have a wide variety of uses and include
prescription and nonprescription drugs, the DEET
insecticide, and caffeine (86 DEN A-11, 5/5/05
(Embedded image moved to file: pic13030.gif)a0b0v4j2f5
).
Other USGS methods have also been used to identify 83
compounds in sediment. Myer said he was finalizing an
extraction method for identifying antibiotics that
should be able to detect another 10 compounds in that
medium.
Sampling for PPCPs at such low levels is challenging
because many of the compounds sought by researchers
are the same as those consumed by researchers, such as
caffeine, or contained in personal or cosmetic
products the researchers may use, Myer said.
"You have to be extra careful when you collect samples
to make sure you're not contaminating" what is being
collected, he said.
One of the more complex research challenges on PPCPs
is that the types of compounds found in effluent
differ depending on the types and the overall mix of
industries found in different regions of the country,
according to Bobbye Smith, of EPA's Region 9 office
and the regional science liaison to EPA's Office of
Research and Development.
"The reason why pharmaceuticals and personal care
products are an issue and why we're talking about it
today is because of the experience of what is
happening out in the regions," Smith said. EPA's
regional offices believe the issue of PPCPs should be
a priority for researchers given how little is known
about the compounds and their effects, she said.
The issue has "bubbled up to the top" of priority
science needs compiled by EPA's regional offices in
recent years, Smith said.
Within EPA's Region 1 office in New England, for
example, researchers are working on analytical methods
for detecting steroid hormones in treated wastewater
from 40 wastewater treatment plants, Smith said. In
the Mid-Atlantic Region 3, the discovery of "intersex"
fish in the Potomac River has led to a coordinated
effort between EPA regional officials and Virginia
researchers to determine the potential source, she
said.
Such research is leading to the development of
genomic-based or molecular biology-based tools that
could have further utility in research on a wider
array of PPCPs, the EPA official said. Such tools are
aimed at examining gene expression in the fish to
determine whether it has been exposed to certain
endocrine disruptors that can augment the reproductive
organs of organisms.
Also within Region 3, researchers are focusing on the
effects of veterinary pharmaceuticals, particularly
those that have antimicrobial effects that may alter
antibiotic resistance in various organisms, Smith
said.
Endocrine Disruptor Research
Smith said EPA's Region 8 office, in conjunction with
the agency's water office, is funding a study on the
potential link between effluent from wastewater
treatment plants and any endocrine disrupting effects
in the white sucker fish.
In Region 9, researchers are participating in a study
of wastewater effluent focusing primarily on the
efficacy of a "new generation" of exposure assays
aimed at better understanding the measurable effects
such compounds might have on organisms, Smith said.
Region 10's focus has primarily been on the
application of veterinary pharmaceuticals, with a
particular focus on how those compounds may affect
various aquaculture farming operations. Researchers in
the region also have been studying the effects of
concentrated animal feeding operations and the effects
of their waste, on water in Idaho, she said.
For that region, "another area they've been trying to
evaluate is the potential impact of large cruise ships
on the local waters," Smith said. While there "is a
huge dilution factor" given the ships are discharging
waste into the Pacific Ocean, "the question is, is
this practice good or not," Smith said.
Taken together, research in the EPA regions should
help other researchers and policymakers get somewhat
closer to answering questions about PPCPs and their
effects on the environment, she said.
"We know we have detected pharmaceuticals in the
environment. But the question is, Does it matter? Is
it important?" Smith asked.
"Are the concentrations that are currently detectable
a problem, or not? That's the gorilla in the closet,
because we really don't know the answer to that
question."(Embedded image moved to file: pic16413.gif)
End of article graphic
By Dean Scott
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