[Pharmwaste] Tons of released drugs taint US water - article about manufacturing

Tenace, Laurie Laurie.Tenace at dep.state.fl.us
Mon Apr 20 09:02:53 EDT 2009


AP IMPACT: Tons of released drugs taint US water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD , 04.19.09, 01:33 PM EDT 
  
http://www.forbes.com/feeds/ap/2009/04/19/ap6308336.html - 


U.S. manufacturers, including major drugmakers, have legally released at
least 271 million pounds of pharmaceuticals into waterways that often provide
drinking water - contamination the federal government has consistently
overlooked, according to an Associated Press investigation.

Hundreds of active pharmaceutical ingredients are used in a variety of
manufacturing, including drugmaking: For example, lithium is used to make
ceramics and treat bipolar disorder; nitroglycerin is a heart drug and also
used in explosives; copper shows up in everything from pipes to
contraceptives.

Federal and industry officials say they don't know the extent to which
pharmaceuticals are released by U.S. manufacturers because no one tracks them
- as drugs. But a close analysis of 20 years of federal records found that,
in fact, the government unintentionally keeps data on a few, allowing a
glimpse of the pharmaceuticals coming from factories in Ohio and other
states.

As part of its ongoing PharmaWater investigation about trace concentrations
of pharmaceuticals in drinking water, AP identified 22 compounds that show up
on two lists: the EPA monitors them as industrial chemicals that are released
into rivers, lakes and other bodies of water under federal pollution laws,
while the Food and Drug Administration classifies them as active
pharmaceutical ingredients.

The data don't show precisely how much of the 271 million pounds comes from
drugmakers versus other manufacturers; also, the figure is a massive
undercount because of the limited federal government tracking.

To date, drugmakers have dismissed the suggestion that their manufacturing
contributes significantly to what's being found in water. Federal drug and
water regulators agree.

But some researchers say the lack of required testing amounts to a 'don't
ask, don't tell' policy about whether drugmakers are contributing to water
pollution.

"It doesn't pass the straight-face test to say pharmaceutical manufacturers
are not emitting any of the compounds they're creating," said Kyla Bennett,
who spent 10 years as an EPA enforcement officer before becoming an ecologist
and environmental attorney.

Pilot studies in the U.S. and abroad are now confirming those doubts.

Last year, the AP reported that trace amounts of a wide range of
pharmaceuticals - including antibiotics, anti-convulsants, mood stabilizers
and sex hormones - have been found in American drinking water supplies.
Including recent findings in Dallas, Cleveland and Maryland's Prince George's
and Montgomery counties, pharmaceuticals have been detected in the drinking
water of at least 51 million Americans.

Most cities and water providers still do not test. Some scientists say that
wherever researchers look, they will find pharma-tainted water.

Consumers are considered the biggest contributors to the contamination. We
consume drugs, then excrete what our bodies don't absorb. Other times, we
flush unused drugs down toilets. The AP also found that an estimated 250
million pounds of pharmaceuticals and contaminated packaging are thrown away
each year by hospitals and long-term care facilities.

Researchers have found that even extremely diluted concentrations of drugs
harm fish, frogs and other aquatic species. Also, researchers report that
human cells fail to grow normally in the laboratory when exposed to trace
concentrations of certain drugs. Some scientists say they are increasingly
concerned that the consumption of combinations of many drugs, even in small
amounts, could harm humans over decades.

Utilities say the water is safe. Scientists, doctors and the EPA say there
are no confirmed human risks associated with consuming minute concentrations
of drugs. But those experts also agree that dangers cannot be ruled out,
especially given the emerging research.


Two common industrial chemicals that are also pharmaceuticals - the
antiseptics phenol and hydrogen peroxide - account for 92 percent of the 271
million pounds identified as coming from drugmakers and other manufacturers.
Both can be toxic and both are considered to be ubiquitous in the
environment.

However, the list of 22 includes other troubling releases of chemicals that
can be used to make drugs and other products: 8 million pounds of the skin
bleaching cream hydroquinone, 3 million pounds of nicotine compounds that can
be used in quit-smoking patches, 10,000 pounds of the antibiotic tetracycline
hydrochloride. Others include treatments for head lice and worms.

Residues are often released into the environment when manufacturing equipment
is cleaned.

A small fraction of pharmaceuticals also leach out of landfills where they
are dumped. Pharmaceuticals released onto land include the chemo agent
fluorouracil, the epilepsy medicine phenytoin and the sedative pentobarbital
sodium. The overall amount may be considerable, given the volume of what has
been buried - 572 million pounds of the 22 monitored drugs since 1988.

In one case, government data shows that in Columbus, Ohio, pharmaceutical
maker Boehringer Ingelheim Roxane Inc. discharged an estimated 2,285 pounds
of lithium carbonate - which is considered slightly toxic to aquatic
invertebrates and freshwater fish - to a local wastewater treatment plant
between 1995 and 2006. Company spokeswoman Marybeth C. McGuire said the
pharmaceutical plant, which uses lithium to make drugs for bipolar disorder,
has violated no laws or regulations. McGuire said all the lithium discharged,
an annual average of 190 pounds, was lost when residues stuck to mixing
equipment were washed down the drain.


Pharmaceutical company officials point out that active ingredients represent
profits, so there's a huge incentive not to let any escape. They also say
extremely strict manufacturing regulations - albeit aimed at other chemicals
- help prevent leakage, and that whatever traces may get away are handled by
onsite wastewater treatment.

"Manufacturers have to be in compliance with all relevant environmental
laws," said Alan Goldhammer, a scientist and vice president at the industry
trade group Pharmaceutical Research and Manufacturers of America.

Goldhammer conceded some drug residues could be released in wastewater, but
stressed "it would not cause any environmental issues because it was not a
toxic substance at the level that it was being released at."

Several big drugmakers were asked this simple question: Have you tested
wastewater from your plants to find out whether any active pharmaceuticals
are escaping, and if so what have you found?

No drugmaker answered directly.

"Based on research that we have reviewed from the past 20 years,
pharmaceutical manufacturing facilities are not a significant source of
pharmaceuticals that contribute to environmental risk," GlaxoSmithKline said
in a statement.

AstraZeneca spokeswoman Kate Klemas said the company's manufacturing
processes "are designed to avoid, or otherwise minimize the loss of product
to the environment" and thus "ensure that any residual losses of
pharmaceuticals to the environment that do occur are at levels that would be
unlikely to pose a threat to human health or the environment."

One major manufacturer, Pfizer Inc., acknowledged that it tested some of its
wastewater - but outside the United States.

The company's director of hazard communication and environmental toxicology,
Frank Mastrocco, said Pfizer has sampled effluent from some of its foreign
drug factories. Without disclosing details, he said the results left Pfizer
"confident that the current controls and processes in place at these
facilities are adequately protective of human health and the environment."

It's not just the industry that isn't testing.

FDA spokesman Christopher Kelly noted that his agency is not responsible for
what comes out on the waste end of drug factories. At the EPA, acting
assistant administrator for water Mike Shapiro - whose agency's Web site says
pharmaceutical releases from manufacturing are "well defined and controlled"
- did not mention factories as a source of pharmaceutical pollution when
asked by the AP how drugs get into drinking water.

"Pharmaceuticals get into water in many ways," he said in a written
statement. "It's commonly believed the majority come from human and animal
excretion. A portion also comes from flushing unused drugs down the toilet or
drain; a practice EPA generally discourages."

His position echoes that of a line of federal drug and water regulators as
well as drugmakers, who concluded in the 1990s - before highly sensitive
tests now used had been developed - that manufacturing is not a meaningful
source of pharmaceuticals in the environment.

Pharmaceutical makers typically are excused from having to submit an
environmental review for new products, and the FDA has never rejected a drug
application based on potential environmental impact. Also at play are
pressures not to delay potentially lifesaving drugs. What's more, because the
EPA hasn't concluded at what level, if any, pharmaceuticals are bad for the
environment or harmful to people, drugmakers almost never have to report the
release of pharmaceuticals they produce.

"The government could get a national snapshot of the water if they chose to,"
said Jennifer Sass, a senior scientist for the Natural Resources Defense
Council, "and it seems logical that we would want to find out what's coming
out of these plants."

Ajit Ghorpade, an environmental engineer who worked for several major
pharmaceutical companies before his current job helping run a wastewater
treatment plant, said drugmakers have no impetus to take measurements that
the government doesn't require.

"Obviously nobody wants to spend the time or their dime to prove this," he
said. "It's like asking me why I don't drive a hybrid car? Why should I? It's
not required."


After contacting the nation's leading drugmakers and filing public records
requests, the AP found two federal agencies that have tested.

Both the EPA and the U.S. Geological Survey have studies under way comparing
sewage at treatment plants that receive wastewater from drugmaking factories
against sewage at treatment plants that do not.

Preliminary USGS results, slated for publication later this year, show that
treated wastewater from sewage plants serving drug factories had
significantly more medicine residues. Data from the EPA study show a
disproportionate concentration in wastewater of an antibiotic that a major
Michigan factory was producing at the time the samples were taken.

Meanwhile, other researchers recorded concentrations of codeine in the
southern reaches of the Delaware River that were at least 10 times higher
than the rest of the river.

The scientists from the Delaware River Basin Commission won't have to look
far when they try to track down potential sources later this year. One mile
from the sampling site, just off shore of Pennsville, N.J., there's a pipe
that spits out treated wastewater from a municipal plant. The plant accepts
sewage from a pharmaceutical factory owned by Siegfried Ltd. The factory
makes codeine.

"We have implemented programs to not only reduce the volume of waste
materials generated but to minimize the amount of pharmaceutical ingredients
in the water," said Siegfried spokeswoman Rita van Eck.

Another codeine plant, run by Johnson & Johnson subsidiary Noramco Inc., is
about seven miles away. A Noramco spokesman acknowledged that the Wilmington,
Del., factory had voluntarily tested its wastewater and found codeine in
trace concentrations thousands of times greater than what was found in the
Delaware River. "The amounts of codeine we measured in the wastewater, prior
to releasing it to the City of Wilmington, are not considered to be hazardous
to the environment," said a company spokesman.

In another instance, equipment-cleaning water sent down the drain of an
Upsher-Smith Laboratories, Inc. factory in Denver consistently contains
traces of warfarin, a blood thinner, according to results obtained under a
public records act request. Officials at the company and the Denver Metro
Wastewater Reclamation District said they believe the concentrations are
safe.

Warfarin, which also is a common rat poison and pesticide, is so effective at
inhibiting growth of aquatic plants and animals it's actually deliberately
introduced to clean plants and tiny aquatic animals from ballast water of
ships.

"With regard to wastewater management we are subject to a variety of federal,
state and local regulation and oversight," said Joel Green, Upsher-Smith's
vice president and general counsel. "And we work hard to maintain systems to
promote compliance."

Baylor University professor Bryan Brooks, who has published more than a dozen
studies related to pharmaceuticals in the environment, said assurances that
drugmakers run clean shops are not enough.

"I have no reason to believe them or not believe them," he said. "We don't
have peer-reviewed studies to support or not support their claims."


Associated Press Writer Don Mitchell in Denver contributed to this report.


The AP National Investigative Team can be reached at investigate (at) ap.org


Laurie Tenace
Environmental Specialist
Waste Reduction Section
Florida Department of Environmental Protection
2600 Blair Stone Rd., MS 4555
Tallahassee FL 32399-2400
P: 850.245.8759
F: 850.245.8811
Laurie.Tenace at dep.state.fl.us 

Mercury: http://www.dep.state.fl.us/waste/categories/mercury/default.htm 

Unwanted Medicine:
http://www.dep.state.fl.us/waste/categories/medications/default.htm



The Department of Environmental 

Protection values your feedback as a customer. DEP Secretary Michael W. Sole is committed to continuously assessing and 

improving the level and quality of services provided to you. Please take a few minutes to comment on the quality of 

service you received. Copy the url below to a web browser to complete the DEP 

survey: http://survey.dep.state.fl.us/?refemail=Laurie.Tenace@dep.state.fl.us Thank you in advance for completing the survey.


More information about the Pharmwaste mailing list