[Pharmwaste] Feds mull regulating drugs in water

DeBiasi,Deborah Deborah.DeBiasi at deq.virginia.gov
Tue Dec 22 14:31:39 EST 2009


AP Enterprise: Feds mull regulating drugs in water

By JEFF DONN, AP National Writer Jeff Donn, Ap National Writer 34 mins

Federal regulators under President Barack Obama have sharply shifted
course on long-standing policy toward pharmaceutical residues in the
nation's drinking water, taking a critical first step toward regulating
some of the contaminants while acknowledging they could threaten human

A burst of significant announcements in recent weeks reflects an
expanded government effort to deal with pharmaceuticals as environmental

* For the first time, the Environmental Protection Agency has listed
some pharmaceuticals as candidates for regulation in drinking water. The
agency also has launched a survey to check for scores of drugs at water
treatment plants across the nation.

* The Food and Drug Administration has updated its list of waste drugs
that should be flushed down the toilet, but the agency has also declared
a goal of working toward the return of all unused medicines.

* The National Toxicology Program is conducting research to clarify how
human health may be harmed by drugs at low environmental levels.

The Associated Press reported last year that the drinking water of at
least 51 million Americans contains minute concentrations of a multitude
of drugs. Water utilities, replying to an AP questionnaire, acknowledged
the presence of antibiotics, sedatives, sex hormones and dozens of other
drugs in their supplies.

The news reports stirred congressional hearings and legislation, more
water testing and more disclosure of test results. For example, an
Illinois law goes into effect Jan. 1 banning health care institutions
from flushing unused medicine into wastewater systems.

The EPA's new study will look for 200 chemical and microbial
contaminants at 50 plants that treat drinking water. The list includes
125 pharmaceuticals or related chemicals. This research will help
federal water officials decide if regulations are needed.

In the first move toward possible drinking-water standards, the EPA has
put 13 pharmaceuticals on what it calls the Contaminant Candidate List.
They are mostly sex hormones, but include the antibiotic erythromycin
and three chemicals used as drugs but better known for other uses.

They join a list of 104 chemical and 12 microbial contaminants that the
EPA is considering as candidates for regulation under the Safe Drinking
Water Act. No pharmaceutical has ever reached the list in its 12-year
history, but medicines now make up 13 percent of the target chemicals on
the latest list "based on their potential adverse health effects and
potential for occurrence in public water systems," the EPA said.

They take a place beside such better-known contaminants as the metal
cobalt, formaldehyde, the rocket fuel ingredient perchlorate, and the
disease germ E. coli.

"I think this does signal a change in the regulatory and research
approaches," said Conrad Volz, a University of Pittsburgh scientist
whose research raises questions about the risk of eating fish from
waters contaminated with sex hormones. "What's happening is pretty

Several scientists within and outside government tied the stronger focus
on human health to the Obama administration and the president's
appointment of Lisa Jackson, a highly regarded former head of the New
Jersey Department of Environmental Protection, to run the EPA.

"I think we are trying to be as aggressive as we can. We understand it's
a major national issue. We understand it's a major public concern," said
Peter Silva, the new water administrator at the EPA.

However, making the candidate list provides no assurance that a chemical
will reach full-blown regulation. In fact, no chemical on the list has
ever been made subject to a national water quality standard, EPA
officials acknowledge. They intend to make preliminary decisions on some
of the latest contaminants by mid-2012.

"They've made a lot of good first steps, so now were waiting to see
those carried through," said Nneka Leiba, a researcher at the
Environmental Working Group in Washington.

Water utilities and drug makers are wary of the federal moves. Difficult
scientific questions remain over the possible threat posed to humans by
minuscule concentrations in drinking water, where drugs are typically
found in parts per billion or trillion. That's way below medical doses.

However, some researchers fear that very small daily amounts of unwanted
drugs in water could do cumulative harm to people over decades, possibly
in combination with other drugs or in sensitive populations like
children or pregnant women. 

Alan Goldhammer, a vice president of the Pharmaceutical Research and
Manufacturers of America, said such trace amounts "really do not pose a
human health issue." 

"We do get concerned if we think that somebody is going to require that
the consumers spend money and not get any health benefit," added Tom
Curtis, a lobbyist for the Denver-based American Water Works

The U.S. Geological Survey first began taking notice of pharmaceutical
contamination several years ago. But until now the federal government
has focused on the presence of pharmaceuticals in rivers and streams. 

A recently released EPA study found more than 40 pharmaceuticals -
everything from antibiotics to heart medicine to antidepressants - at
nine publicly owned wastewater treatment plants. The drugs appeared in
concentrations measured in parts per billion and trillion. Many passed
right through the plants. 

Linda Birnbaum, who is director of the National Institute of
Environmental Health Sciences and also oversees the National Toxicology
Program, said some program research is focusing on how much
environmental pharmaceuticals can reach animal blood and tissues and how
that might compare with humans. 

Waste pharmaceuticals reach the environment when people take medicine
and excrete the unmetabolized portion. Millions of pounds of waste drugs
also escape into waterways from hospitals, drug plants and other
factories, farms and the drains of American homes, the AP has reported. 

On its new list, the FDA, which regulates medicines, says only 10 active
ingredients in controlled-substance drugs need to be flushed to keep
them away from children, abusers and pets. 

At the same time, the agency announced it is working with partners to
develop programs to return unused drugs instead of flushing them down
the drain. The agency wants "to encourage their development and future
use for all drugs," declared Dr. Douglas Throckmorton, deputy director
of the FDA's Center for Drug Evaluation and Research. Returned drugs are
usually incinerated, which destroys most active ingredients. Community
drug takeback programs have increased considerably since the AP's
PharmaWater reports. 

The recent announcements have been striking in their speed and breadth.
Just last year, Ben Grumbles, Silva's predecessor at the EPA Office of
Water under President George W. Bush, said only one pharmaceutical was
under consideration for the list of candidates for water standards. And
it was the heart medicine nitroglycerin, better known as an explosive. 

Yet some environmentalists say the government should take even bolder
action. "Identifying the nature and scope of the problem is not the same
thing as addressing the causes of the problem," said George Mannina, an
environmental lawyer in Washington. 

He said the EPA should do more to keep drugs out of the nation's water
supplies and not rely on expensive filtering systems at water treatment

Jon Holder, a vice president at Vestara, a seller of equipment to manage
waste drugs, said the EPA should be more aggressive about enforcing
hazardous waste laws that already apply to some drugs used by hospitals.

"We applaud the light that's being shined on it, but we also recognize
that the simple enforcement of existing law would go a long way," he


On the Net: 

EPA Contaminant Candidate List: 


FDA flush list:

Copyright (c) 2008

Deborah L. DeBiasi 
Email:   Deborah.DeBiasi at deq.virginia.gov (NEW!)
WEB site address:  www.deq.virginia.gov 
Virginia Department of Environmental Quality 
Office of Water Permit Programs 
Industrial Pretreatment/Whole Effluent Toxicity (WET) Program 
PPCPs, EDCs, and Microconstituents
Mail:          P.O. Box 1105, Richmond, VA  23218 
Location:  629 E. Main Street, Richmond, VA  23219 
PH:         804-698-4028 
FAX:      804-698-4032 

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