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04-19-2009
AP IMPACT:
Tons of Released Drugs Taint US Water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD
Associated Press Writers
 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.
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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
04/19/09 21:10 © Copyright The Associated Press
Water Pollution
Water pollution is the contamination of water bodies such as lakes, rivers, oceans, and groundwater caused by human activities, which can be harmful to organisms and plants that live in these water bodies.
It occurs when pollutants are discharged directly into water bodies without treating it first.
Water pollution is a major problem in the global context. It has been suggested that it is the leading worldwide cause of deaths and diseases, and that it accounts for the deaths of more than 14,000 people daily.
In addition to the acute problems of water pollution in developing countries, industrialized countries continue to struggle with pollution problems as well.
In the most recent national report on water quality in the United States, 45 percent of assessed stream miles, 47 percent of assessed lake acres, and 32 percent of assessed bay and estuarine square miles were classified as polluted.
Water is typically referred to as polluted when it is impaired by anthropogenic contaminants and either does not support a human use, like serving as drinking water, and/or undergoes a marked shift in its ability to support its constituent biotic communities, such as fish.
Natural phenomena such as volcanoes, algae blooms, storms, and earthquakes also cause major changes in water quality and the ecological status of water. Water pollution has many causes and characteristics.
Clean Water Act
In the USA, concern over water pollution resulted in the enactment of state anti-pollution laws in the latter half of the 19th century, and federal legislation enacted in 1899.
The Refuse Act of the federal Rivers and Harbors Act of 1899 prohibits the disposal of any refuse matter from into either the nation's navigable rivers, lakes, streams, and other navigable bodies of water, or any tributary to such waters, unless one has first obtained a permit.
The Water Pollution Control Act, passed in 1948, gave authority to the Surgeon General to reduce water pollution. However, this law did not lead to major reductions in pollution.
Growing public awareness and concern for controlling water pollution led Congress to carry out a major re-write of water pollution law in 1972.
The Federal Water Pollution Control Act Amendments of 1972, commonly known as the Clean Water Act (CWA), established the basic mechanisms for controlling point source pollution.
The law mandated the United States Environmental Protection Agency (EPA) to publish and enforce wastewater standards for industry and municipal sewage treatment plants. The Act also continued requirements that EPA and states issue water quality standards for surface water bodies.
Congress included authorization in the Act for major public financing to build municipal sewage treatment plants. The 1972 CWA, however, did not require similar regulatory standards for non-point sources.
In 1987, Congress expanded the coverage of the CWA with enactment of the Water Quality Act.
These amendments defined both municipal and industrial stormwater discharges as point sources and required these facilities to obtain discharge permits.
The 1987 law also re-organized the public financing of municipal treatment projects and created a non-point source demonstration grant program.
Further amplification of the CWA included the enactment of the Great Lakes Legacy Act of 2002
GLOBAL WATER POLLUTION
Estimates suggest that nearly 1.5 billion people lack safe drinking water and that at least 5 million deaths per year can be attributed to waterborne diseases. With over 70 percent of the planet covered by oceans, people have long acted as if these very bodies of water could serve as a limitless dumping ground for wastes.
Raw sewage, garbage, and oil spills have begun to overwhelm the diluting capabilities of the oceans, and most coastal waters are now polluted.
Beaches around the world are closed regularly, often because of high amounts of bacteria from sewage disposal, and marine wildlife is beginning to suffer.
Perhaps the biggest reason for developing a worldwide effort to monitor and restrict global pollution is the fact that most forms of pollution do not respect national boundaries.
The first major international conference on environmental issues was held
in Stockholm, Sweden, in 1972 and was sponsored by the United Nations (UN).
This meeting, at which the United States took a leading role, was controversial because many developing countries were fearful that a focus on environmental protection was a means for the developed world to keep the undeveloped world in an economically subservient position.
The most important outcome of the conference was the creation of the United Nations Environmental Program (UNEP).
UNEP was designed to be ?the environmental conscience of the United Nations,? and, in an attempt to allay fears of the developing world, it became the first UN agency to be headquartered in a developing country, with offices in Nairobi, Kenya.
In addition to attempting to achieve scientific consensus about major environmental issues, a major focus for UNEP has been the study of ways to encourage sustainable development increasing standards of living without destroying the environment.
At the time of UNEP's creation in 1972, only 11 countries had environmental agencies. Ten years later that number had grown to 106, of which 70 were in developing countries.
On a remote patch of ocean, the crew of the research ship JOIDES Resolution have lowered a massive drill bit through 3 miles of pipe to the seafloor below.
Scientists hope to learn how the Earth responded to climate change 50 million years ago.
CAUSES OF POLLUTION
Many causes of pollution including sewage and fertilizers contain nutrients such as nitrates and phosphates. In excess levels, nutrients over stimulate the growth of aquatic plants and algae.
Excessive growth of these types of organisms consequently clogs our waterways, use up dissolved oxygen as they decompose, and block light to deeper waters.
This, in turn, proves very harmful to aquatic organisms as it affects the respiration ability or fish and other invertebrates that reside in water.
Pollution is also caused when silt and other suspended solids, such as soil, washoff plowed fields, construction and logging sites, urban areas, and eroded river banks when it rains.
Under natural conditions, lakes, rivers, and other water bodies undergo Eutrophication, an aging process that slowly fills in the water body with sediment and organic matter.
When these sediments enter various bodies of water, fish respirationbecomes impaired, plant productivity and water depth become reduced, and aquatic organisms and their environments become suffocated.
Pollution in the form of organic material enters waterways in many different forms as sewage, as leaves and grass clippings, or as runoff from livestock feedlots and pastures.
When natural bacteria and protozoan in the water break down this organic material, they begin to use up the oxygen dissolved in the water. Many types of fish and bottom-dwelling animals cannot survive when levels of dissolved oxygen drop below two to five parts per million.
When this occurs, it kills aquatic organisms in large numbers which leads to disruptions in the food chain.
Three last forms of water pollution exist in the forms of petroleum, radioactive substances, and heat. Petroleum often pollutes waterbodies in the form of oil, resulting from oil spills. The previously mentioned Exxon Valdez is an example of this type of water pollution.
These large-scale accidental discharges of petroleum are an important cause of pollution along shore lines. Besides the supertankers, off-shore drilling operations contribute a large share of pollution. One estimate is that one ton of oil is spilled for every million tons of oil transported.
This is equal to about 0.0001 percent. Radioactive substances are produced in the form of waste from nuclear power plants, and from the industrial, medical, and scientific use of radioactive materials. Specific forms of waste are uranium and thorium mining and refining.
The last form of water pollution is heat. Heat is a pollutant because increased temperatures result in the deaths of many aquatic organisms. These decreases in temperatures are caused when a discharge of cooling water by factories and power plants occurs.
Agriculture, including commercial livestock and poultry farming, is the source of many organic and inorganic pollutants in surface waters and groundwater.
These contaminants include both sediment from erosion cropland and compounds of phosphorus and nitrogen that partly originate in animal wastes and commercial fertilizers.
Animal wastes are high in oxygen demanding material, nitrogen and phosphorus, and they often harbor pathogenic organisms.
Wastes from commercial feeders are contained and disposed of on land; their main threat to natural waters, therefore, is from runoff and leaching.
Control may involve settling basins for liquids, limited biological treatment in aerobic or anaerobic lagoons, and a variety of other methods.
Wastewater Treatment
Raw sewage includes waste from sinks, toilets, and industrial processes.
Treatment of the sewage is required before it can be safely buried, used, or released back into local water systems.
In a treatment plant, the waste is passed through a series of screens, chambers, and chemical processes to reduce its bulk and toxicity.
The three general phases of treatment are primary, secondary, and tertiary.
During primary treatment, a large percentage of the suspended solids and inorganic material is removed from the sewage.
The focus of secondary treatment is reducing organic material by accelerating natural biological processes.
Tertiary treatment is necessary when the water will be reused; 99 percent of solids are removed and various chemical processes are used to ensure the water is as free from impurity as possible.
Important Terms
Aquifers - natural rock formations, which contain ground water.
Eutrophication - The process of slowly filling in a water body with sediments and organic matter.
Non point source - delivers pollutants indirectly through environmental changes. One way in, which this occurs, is through run-off.
Pathogens - or disease producing organism
Point source - occurs when harmful substances are emitted directly into a body of water. One way in which this occurs, is when someone throws a coke can into a body of water.
Pollution - to make foul or unclean; dirty.
Sediments - minerals or organic matter deposited by water, air, or ice...matter which settles to the bottom a liquid.
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