Feds Mull Regulating Drugs in Water

December 23, 2009

AP News

By Jeff Donn

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 health.

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

- 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 amazing.”

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 Association.

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 plants.

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 said.

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BPA Tied to Impotence in Men

November 11, 2009

ABCNews

By Joseph Brownstein

While environmental groups have sounded the alarm about the presence of bisphenol-A, or BPA, in products such as infant formula, baby bottles and other plastics, a new study provides some of the first evidence that the chemical can be harmful to humans, linking it to sexual dysfunction in men in high doses.

Researchers looked at 550 factory workers in China, some of whom were exposed to BPA as part of their job, and found that men who worked with BPA were four times more likely than their counterparts who did not work with the chemical to report some level of sexual dysfunction.

“The study certainly provides the human evidence to confirm animal studies, but one study is not going to answer any questions,” said Dr. De-kun Li, the study’s lead author and a reproductive and perinatal epidemiologist at Kaiser Permanente’s Division of Research in Oakland, Calif.

Li noted that while BPA’s presence has been confirmed in a number of consumer products, all studies before now had only shown harm in nonhuman populations.

“Up to this point, it’s largely, basically animal studies,” said Li, explaining that little has been done about BPA because of a lack of studies in people.

“There has been no human studies, at least in the context of the male reproductive system, so this has been dismissed by some critics,” he said of the potential harms BPA may pose.

But Li acknowledged that the current study will likely do little to change policy, since the levels of BPA were much higher than those encountered by the average person in his or her daily life. The average worker exposed to BPA had levels roughly 50 times higher than the average person.

“At this point … we don’t know the safety of the lower level,” he said, but noted that people do not need to worry too much. “We don’t have to be alarmed and go crazy.”

In the study, 15.5 percent of men exposed to BPA complained of erectile dysfunction more than half of the time, while only 4.4 percent of men not exposed to BPA had the same complaint. Meanwhile, 13.9 percent of men with BPA exposure on the job complained of difficulty ejaculating, while only 2.5 percent of men without the on-the-job BPA exposure had the same complaint.

While previous reports on BPA have relied heavily on animal studies, none have promoted a ban on the substance.

The National Toxicology Program, part of the National Institutes of Health, considers BPA to be a substance of “some concern” — the third level of a five-part scale ranging from “serious concern” to “negligible concern.”

“There are insufficient data from studies in humans to reach a conclusion on reproductive or developmental hazards presented by current exposures to BPA, but there is limited evidence of developmental changes occurring in some animal studies at doses that are experienced by humans. It is uncertain if similar changes would occur in humans, but the possibility of adverse health effects cannot be dismissed,” the agency writes about BPA in its factsheet.

It is unclear exactly how BPA would cause sexual dysfunction, according to Dr. Michele Marcus, a professor and interim chair in the department of epidemiology and environmental health at Emory University’s Rollins School of Public Health. One possible explanation, she said, is that BPA, a known endocrine disruptor, can mimic estrogen and block some effects of testosterone.

Avoiding BPA ‘Would Be My Advice,’ Doctor Says

Because his study does not provide answers for the average person looking to know if BPA will do him or her harm, Li said any steps would be strictly precautionary.

“It’s certainly based on everybody’s risk tolerance level,” he said, adding that avoiding BPA “would be my advice. It’s unlikely the regulatory agencies will do anything yet, because they would like to see the evidence from human studies.”

“If there’s credible evidence of the potential of harm, why not look for a safer alternative?” said Kathy Gerwig, vice president for workplace safety and environmental stewardship officer at Kaiser Permanente.

Gerwig said that while BPA has not been proven harmful, there were steps consumers could take if they wanted to reduce their BPA exposure.

“If you’re going to buy a rigid plastic bottle, look for one that is BPA-free,” she said.

Second, Gerwig recommended avoiding canned foods, which contain BPA in the linings, something she said would be advantageous because it promoted eating fresh foods.

Third, she said, “It’s a smart decision to stay away from heating foods in the microwave in plastics.”

Industrial Scale

Given the high levels of BPA industrial workers were exposed to in the study, many may be tempted to dismiss the much lower levels of exposure the average person experiences.

But paradoxically, lower levels may be more harmful, explained Dr. David Ozonoff, a professor of environmental health at the Boston University School of Public Health.

“These are hormone-like chemicals, and your body is used to responding to hormones at really low levels,” he said.

He compared it to two friends in a crowded bar trying to speak, who cannot do so because of the noise. In those circumstances, the noise may be cancelled out, while in a quieter room, that message may be heard and listened to.

For a signal that has the potential to be disruptive, said Ozonoff, a signal that can be “heard” can be more dangerous than a large number of signals that can be dismissed as static.

“That’s one of those things that we worry about,” he said.

Ozonoff said the study is still open to interpretation, and further studies will need to be done for any conclusions to be drawn about the potential harmfulness of BPA.

However, he concluded, “There’s nothing about this that should give any comfort to someone that thinks BPA is OK.”

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