Pharmaceuticals in our water an emerging concern

By Stacy Gittleman

We live in a time of accelerated advancements in medicine. Thankfully, new drugs are coming on the market all the time to manage once untreatable diseases such as cancer, diabetes, high blood pressure, anxiety and depression. Every other commercial on television it seems is for a new drug.

But as with anything beneficial in our 21st century world, we are becoming increasingly aware that everything we do, consume and discard, including taking our medicine, can have a negative impact on the environment. When we take drugs, whatever is not used by our body is excreted into the wastewater stream. And it is estimated that up to 90 percent of the medicines we ingest eventually gets flushed out of our systems. In our waste, they head to wastewater treatment plants which are not equipped or mandated by law to filter out and treat trace amounts of the thousands of chemical compounds found in pharmaceuticals before these waters head into the environment and ultimately, our drinking water supplies.

In recent years, threats to safe clean drinking water have showed up in the headlines. The Flint water crisis, now going on a decade, prompted the entire country to rid its entire water infrastructure of lead service lines by 2040. In June, it was announced that chemical giant 3M will pay out over $10 billion to municipalities across the nation whose water supplies have been poisoned by per- and polyfluorinated substances, known collectively as PFAS. The settlement, which could go as high as $12.5 billion, will be paid out over 13 years to the public water systems which will all now be testing for PFAS over the next three years, as mandated by the U.S. Environmental Protection Agency (EPA).

Right now, the presence of PFAS and lead – chemicals never intended for human consumption – are taking the front seat in terms of priorities for water resource managers across the nation in comparison to the presence of small amounts of medications. Even so, researchers for decades have been warning about the presence of steroids, pain relievers, and even caffeine in our water. Regulations to purify our waters from these substances are not even on the far horizon.

In 2008, the Associated Press published a story that was the result of a five-month investigation of the quality of drinking water in 24 metropolitan areas, including Detroit. The news agency discovered that 41 million Americans were vulnerable to drinking water laced with everything from antibiotics, anticonvulsants, mood stabilizers and sex hormones. Though these contaminants measured in parts per billion or trillion – far lower than a therapeutic dose – researchers in the last decade have proven that these tiny amounts are showing up in adverse health effects for aquatic life and may do the same in the long term for humans.

In recent years, several published studies are bringing the issue back into the spotlight around the presence of drugs in the Great Lakes.

The most recent study, “Persistent Contaminants of Emerging Concern in a Great Lakes Urban-Dominant Watershed,” was published in February 2022 by the Journal of Great Lakes Research and conducted by members of the Healthy Urban Waters research group at Wayne State University.

Between the spring of 2018 and the fall of 2019, researchers collected and sampled surface water and sediment at multiple locations in the Lake Huron to Lake Erie corridor to investigate more than 150 chemicals of emerging concern. Surface water was analyzed for pharmaceutical and personal care products, pesticides and PFAS. Sediment was analyzed for PFAS. Researchers detected 50 compounds at elevated levels, including synthetic sweeteners which were at 55.7 percent of the cumulative concentration of all compounds detected across sampling events, followed by pesticides (27.5 percent), pharmaceuticals (11.7 percent), and stimulants (3.5 percent), with 14 compounds consistently detected: artificial sweeteners such as acesulfame-potassium and sucralose; antibiotics such as sulfamethoxazole; acetaminophen, lidocaine, the high blood pressure medication atenolol, cholesterol treatments such as gemfibrozil, the contrast dye iohexol, caffeine and others.

According to the study, chemicals of concern primarily enter the environment from the effluent of wastewater treatment plants which are not designed, nor regulated, to remove these organic compounds. Contaminants also enter the waters from combined sewer overflows or runoff from agricultural and livestock sources which often use the antibiotics to treat their animals that are also used for humans.

The lead researcher in this study of these contaminants of emerging concern was Tracie Baker, an associate professor in the Department of Environmental and Global Health at the University of Florida with an affiliate appointment at Wayne State University. A triathlete who learned to swim at the age of four on the shores of Lake Erie and spent several years living in Michigan, Baker spent the last six years studying levels of contaminants in the Great Lakes.

Baker studies how levels of pharmaceuticals and other contaminants affect the quality of life of the zebrafish minnow. Baker said that close to 80 percent of the minnow’s genes mimic the functions of human genes that are involved in disease. With a rapid incubation and reproductive cycle, scientists can easily observe how chemicals in their environment impact the health of these fish up to four generations per year. Baker said despite environmental progress over the decades, she, and the fish, find themselves swimming in a “soup of contaminants.”

Baker said that the ability to effectively remove contaminants like pharmaceuticals and illicit drugs from wastewater varies greatly depending on the treatment plant and filter technology that is available.

“Some treatment plants are around 100 years old and were built in a time when medications in the water were not an issue or concern,” Baker said.  “Advanced filter techniques are very expensive to treat and clean water at that large scale.  Wastewater is being tested for some contaminants but is not usually tested for many of the contaminants of emerging concern. So yes, our results have shown that there continues to be medications and other household and personal care products in the Detroit River and Great Lakes.”

Baker added that federal regulatory agencies can – and should – set limits on categories of chemicals they deem as hazardous to the environment and human health. She said that when a pharmaceutical company applies for new drug approval, it must submit an estimate of how much that drug will end up in the environment.

“Pharmaceutical companies use modeling that takes into account how many people they think will use the drug, how it will pass through the body, and how it will degrade in water. If the estimate is over one part per billion, the FDA can request for a more thorough evaluation of how the drug will affect aquatic life. Most companies report less than that quantity, so the number of regulations on any one specific drug are low,” she said.

Another set of published studies in the last decade has been led by Rebecca Klaper, dean and professor at the School of Freshwater Sciences and director of the Great Lakes Genomic Center at the University of Wisconsin-Milwaukee. Beginning in 2013, she and a team of researchers published findings which examined water from Milwaukee’s public drinking water supplies pulled from Lake Michigan. They found 27 different chemicals of emerging concern, including antibiotics, caffeine, antifungal drugs and other consumer products.

Klaper focuses her work on the behavior of juvenile fathead minnows, common in Lake Michigan, in controlled laboratory environments, when exposed to contaminants such as estrogen hormones and drugs used to treat diabetes II, depression, and anxiety which were detected in Lake Michigan. Like zebra minnows, their brain organ development mimics that of humans.

What was most concerning to the team was the high presence of metformin, a drug used to treat type 2 diabetes. According to the National Institutes of Health, the cumulative concentration of metformin and its byproducts in wastewater and aquatic environments can lead to ailments such as lactic acidosis – which prevents organ tissue from receiving proper levels of oxygen, and vitamin B12 deficiency in aquatic life. Specifically, Klaper discovered that metformin was causing endocrine disruption in adult male fish.

“Prior to the study, we were not expecting metformin to stick around for such a long period of time, or for the drug to be detectable in such a big water body,” Klaper said. “That started to get the wheels spinning for other (researchers) who began to measure for metformin around the globe. Now, it’s one of the top drugs that is measured, and it is present in waterways all over the world.”

Klaper said that while the pharmaceutical industry has funded their own research and claims that metformin breaks down in the environment, scientists such as herself are finding the opposite. “It is not really breaking down in a way that can be properly handled by a wastewater treatment plant and still shows up in wastewater effluent.”

She continued: “What it’s doing to fish is similar to what it is doing to humans, but these are humans who have been prescribed the drug to their benefit. But it is affecting these fish in lower concentrations, not the prescribed therapeutic concentrations.”

During the years following the publishing of these studies, Klaper said researchers have collected even more data on the presence of a bevy of drugs in our waters, but all this data just leads to more questions.

“It has been confirmed that yes, there are low concentrations of many pharmaceuticals in our water,” she said. “Even though they are at low levels that may not have a negative impact on human health, they are having adverse effects on aquatic organisms in the environment. These are not levels that would be considered therapeutic to humans, and it is not all drugs which are being detected. But which drugs do we need to test our waters for? Which do we need to have the most concern about, and how do we best evaluate the effects for these drugs? These questions remain unanswered.”

Klaper has also studied the effects of antidepressants on aquatic life.

To counter the nation’s mental health crisis, antidepressants are the most prescribed class of medications in the United States, at the rate of approximately 250 million prescriptions per year.

In a study titled “Environmental Concentrations of The Selective Serotonin Reuptake Inhibitor Fluoxetine Impact Specific Behaviors Involved in Reproduction, Feeding And Predator Avoidance In The Fish Pimephales Promelas (Fathead Minnow),” published in 2014 in the journal Aquatic Toxicology, Klaper discovered that when exposed to fluoxetine (Prozac) at the rate of one part per billion, male minnows ignored females in a laboratory setting. Their reproduction decreased and they also had a slower time capturing prey.

When the dose was increased, but still at levels found in some wastewater, Klaper reported that females produced fewer eggs and males became aggressive, killing females in some cases.

The next steps in this field of research are to examine the impacts of chemical compounds, or what happens when a multitude of these drugs interact with other contaminants in the water and within organisms. And this only leads to more questions. “Mixtures are a big deal,” Klaper said. “It is common that not just one compound is found in the body of a fish, but it’s found in conjunction with other pharmaceuticals all acting on the same biological pathway. What happens when a low enough concentration of one medication that does not cause a harmful impact combines with another one or two chemicals? Will that have a bigger effect? So, trying to evaluate a potential environmental impact from all sorts of combinations is very difficult, and even more difficult is to determine how or which to regulate.”

But, compared to things like mercury, lead and PFAS forever chemicals, the presence of pharmaceuticals is not high on the priority list to target and regulate. Despite all the research findings, there are few mechanisms at the federal level to regulate the levels of pharmaceuticals in drinking water via the Clean Water Act or the Safe Drinking Water Act.

“As of right now, there has been no determination that the low levels of pharmaceuticals being detected have caused toxicity in humans. So, therefore, the EPA has not concerned themselves with setting regulations on them,” Klaper said.

Michael Murray, an adjunct associate professor for the School for Environment and Sustainability at the University of Michigan, agrees with Klaper’s view. Unlike toxic substances that were never intended for consumption, it is unlikely that pharmaceuticals will receive the regulation status such as lead or forever chemicals that have been found in our drinking water.

Murray explained that it is improbable that pharmaceutical companies will face the same litigation such as PFAS manufacturers just because remnants of their products wind up flowing from the tap.

“A class action lawsuit involving the pharmaceutical industry will be unlikely,” Murray said. “This is because a chemical first must be listed as a chemical of concern by the EPA before it could be regulated for count levels in our drinking water. The situation with pharmaceuticals is different from that of PFAS because drugs are designed for human consumption. Chemicals of concern which are regulated by maximum contaminant levels are typically industrial chemicals that cause environmental contamination. So, it is hard to envision a time when the EPA would develop maximum contaminant levels for the thousands of pharmaceuticals on the market that may show up in our drinking water. Even though we know they are present, they would have to show up in very high levels – and levels that would have to be individually determined for each drug – before the EPA would even consider regulating them. Right now, it can be assumed that the EPA has higher priorities on the chemicals in our waterways that it is looking at in terms of regulation.”

Murray said research is lagging on how trace levels of drugs are affecting human health. But there is data on how it is impacting aquatic life.

“For years, there has been concern about endocrine disrupting chemicals, such as hormones, coming out of the effluent of wastewater treatment plants. If there would be any area to establish regulations, it would be at the wastewater effluent level. But wastewater treatment plants were never designed to treat water for the presence of pharmaceuticals. But advanced techniques such as reverse osmosis are highly energy intensive and extremely expensive for the incremental reduction of pharmaceutical levels that would result.”

Such advanced techniques have yet to reach U.S. shores, but they are being tested out in Europe. In June, a town in Sweden announced that they would be piloting a filtration technique in one town that would eliminate up to 80 percent of five detected medications. This may one day help support the European Commission’s more stringent rules about not just identifying but cleaning up pharmaceuticals in wastewater, part of the European Green Deal to clean up air, land and water from legacy contaminations by 2050. There are laws being introduced for wastewater treatment that will require pharmaceutical companies in Europe to pay for more advanced filtration systems. According to an October 2022 press release from the European Commission, as 92 percent of toxic micro-pollutants found in EU wastewaters come from pharmaceuticals and cosmetics, a new Extended Producer Responsibility scheme will require producers to pay for the cost of removing them.

In comparison, in the United States, laws are lagging scientific findings. Every five years, the EPA adds to its chemicals of emerging concern list based on studies and comment sessions open to the public according to the Safe Drinking Water Act and the Clean Water Act. But just because chemicals make it to the list does not mean they will be subjected to any proposed drinking water regulations. It just means that they have been detected and measured in public water systems.

The EPA in an email stated: “When it comes to drinking water, EPA’s assessment of pharmaceuticals has not identified any that meet the criteria for regulation under the Safe Drinking Water Act, to date.”

Since 1998, the EPA published five such lists. For the fifth Contaminant Candidate List, published in 2022, the EPA implemented improvements to the process to identify those contaminants with the greatest potential for public health concern, and short listed the following pharmaceuticals to be included on the list: estrogen drugs including 17‐alpha‐ethynyl estradiol, 2-aminotoluene, carbaryl, and antidepressants including desvenlafaxine, fluconazole, lithium and quinoline.

Contaminants listed may require future regulation under the Safe Drinking Water Act (SDWA). Once listed, the SDWA directs the EPA to consider the health effects of these unregulated contaminants as the agency makes decisions to place contaminants on the list. The EPA uses this list to identify priority contaminants for regulatory decision making and information collection.

Public water systems are not required to make any changes or adjustments to their treatment activities according to what chemicals get published onto this list. If the EPA decides to regulate a contaminant on the list in the future, the EPA will start a separate rule making process with opportunity for public comment.

The EPA stated that it will continue to consider new information on pharmaceuticals as it becomes available for future contaminant candidate lists.

Additionally, under the Safe Drinking Water Act, the EPA every five years has issued Unregulated Contaminant Monitoring Rules with requirements for water systems to monitor for unregulated contaminants to gather nationally representative data on the frequency and level of these contaminants in drinking water.

Released in 2017, the EPA’s third Unregulated Contaminant Monitoring Rule required monitoring for 30 contaminants between 2013 and 2015. The EPA surveyed public water systems serving more than 100,000 people, including 320 systems that served between 10,001 to 100,000 people, and 480 systems serving 10,000 or fewer people in locations across the country. The systems were monitored for seven hormones, including those used in birth control pills and steroids.

The Safe Water Drinking Act also guides the EPA on how to determine whether a contaminant included on the Contaminant Candidate List warrants regulation. A decision to create a National Primary Drinking Water Regulation for a certain contaminant, such as a drug, depends if that chemical would have to meet the following criteria based on peer-reviewed studies: There must be proof that if in drinking water, that drug may have adverse human health effects; the contaminant’s appearance is occurring at widespread levels and frequencies within a public water system to make it a public health concern; and that regulation of that contaminant would result in meaningful reductions of health risks.

To date, the EPA has yet to identify any drug that has fallen into these criteria under the Safe Drinking Water Act.

Officials at the Michigan Department of Environment, Great Lakes and Energy (EGLE) declined an interview with Downtown Newsmagazine because there are no state or federal regulations concerning pharmaceutical residues in drinking water for the agency to enforce. EGLE spokesperson Jeff Johnston in an email stated that without set laws, individual wastewater and drinking water systems are responsible for how they choose to address treatment or testing for pharmaceutical contaminants.

“While studies are examined at a federal level, EGLE has been working on education to help get unwanted medications diverted to incineration facilities for proper disposal in adherence with Part 115 of the Natural Resources and Environmental Protection Act, which was amended in 2014 to include the creation of waste diversion centers across the state,” explained Johnston. “This allowed for the collection and diversion of household hazardous waste from landfill disposal to environmentally preferable management methods,” Johnston stated. “Since the amendment, the number of takeback locations across Michigan has grown to include collections hosted by retail pharmacies, health care providers, police stations, and drug abuse prevention centers. Though EGLE does not host any collection centers, it educates on safe disposal on our website, which has attracted nearly 19,000 visitors since it was launched in 2022.”

Johnston continued: “This topic is worthy of more study. EGLE’s Drinking Water and Environmental Health Division emerging contaminants team has been considering the issue and the challenges of addressing the wide class of contaminants involved.”

Water resources officials agree that tackling the problem must occur further upstream, with better medication prescribing, disposal and recovery practices.

Oakland County Water Resources Commissioner James Nash said the county’s wastewater treatment plants and smaller facilities are following state and federal regulations, and until regulations are enacted from the federal government to filter out pharmaceuticals, wastewater professionals such as himself are in compliance and there is little they are involved with concerning pharmaceuticals in the water. Nash said everyone can play a part in preventing drugs from getting washed into the waterways by educating themselves on proper disposal methods of unused medications.

In Oakland County, for example, Operation Medicine Cabinet™ has had a multifold mission of keeping the community safer from misuse and abuse of prescription drugs as well as providing resources to properly dispose of unused medications. There are 37 Operation Medicine Cabinet drop off sites, including 13 sheriff’s office locations and 24 other law enforcement locations in the county.

Statewide, in 2021 alone, the U.S. Drug Enforcement Administration reported that Michigan collected nearly 23,000 pounds of unwanted prescription pills on its annual “Rx Takeback Day.” During this year’s 24th takeback event, Michigan collected 26,601 pounds.

“There has been a huge effort on drug collection and education on proper drug disposal in the state,” said Nash. “But in terms of permits and regulations to track and detect the minute amounts of drugs found in our water, we have little to do with this because we are not regulated to do so.”

Nash added that Oakland County’s wastewater treatment plants will occasionally monitor for the presence of diseases like hepatitis. At the height of the COVID pandemic, monitoring wastewater and sewerage was a useful technique in understanding the level of cases in certain communities, and predicting when case surges may occur.

He maintained: “But the levels of pharmaceuticals are at such trace levels, unless we discover that there is a pervasive presence of a certain drug, monitoring for trace amounts of pharmaceuticals in our wastewater is not something our office spends a lot of time or effort monitoring. According to federal regulations, we must conduct regular testing for substances such as lead or arsenic, and now PFAS (where we have been experiencing high levels in places like Kent Lake or in the Huron River). But as far as drugs, it’s just not something we are tasked with.”

From a drinking water management standpoint, Cheryl Porter, chief operating officer of Water and Field Services for the Great Lakes Water Authority (GLWA), stated that GLWA’s drinking water is compliant with state and federal drinking water regulations and monitoring requirements.

“The authority has a rigorous industrial pre-treatment program that controls contaminants, including PFAS, directly at their source before entering waste streams,” Porter stated. “Additionally, GLWA occasionally conducts unregulated monitoring sampling events for contaminants such as estrogen compounds and compounds often found in personal care products. The EPA then uses the data obtained to determine where these contaminants occur and whether they need to be regulated.”

Echoing the words of other water authority officials, Porter said that GLWA discourages the improper disposal of medications to help prevent potentially harmful ingredients from medications from making their way into water sources, even though its water and wastewater are treated.

In Ann Arbor, Brian Stieglitz, from the city’s wastewater treatment plant, said pharmaceuticals in water falls more in the jurisdiction of drinking water authorities.

“Usually it’s the drinking water side that drives wastewater regulations,” Stieglitz said. “We found that there are very, very low levels of pharmaceuticals and other drug substances in our source water, which we pull from the Huron River. You would have to drink about 1,000 gallons of our water to get the caffeine equivalent in one cup of coffee, for example. So, this is not really the focus from the wastewater side.”

One of the most prominent and early voices on raising awareness and studying this issue on a national and even global scale is Dana Kolpin, a research hydrologist with the Central Midwest Water Science Center of the U.S. Geological Survey.

Kolpin has been researching the presence of drugs in waterways since the 1990s. His paper “Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: A national reconnaissance,” was a pioneering study on chemicals of emerging concern in water sources.

“That paper was what I call the stream of reconnaissance,” Kolpin said. “That was a seminal paper which was heavily cited as it was one of the first studies to look at the presence of pharmaceuticals on a national scale.”

Kolpin said when this waste hits the treatment plants, they have no way of removing the drug from the water, nor are wastewater treatment plants in areas with smaller populations economically equipped to outfit their facilities with advanced technologies that would only incrementally move the needle to slightly reduce the counts of contaminants.

“The wastewater treatment plants are not out of compliance,” Kolpin noted. “They are doing exactly what they are regulated to do.”

Kolpin also contributed to the 2022 study, “Pharmaceuticals in the world’s rivers,” published by the National Academy of Sciences and winner of the prestigious Cozzarelli Prize from the World Health Organization. The study includes reporting on 1,052 sites along 258 rivers in 104 countries to reflect the environmental impact of 471.4 million people. In their analysis of 61 pharmaceutical ingredients, the authors found the highest levels of pharmaceutical pollution in sub-Saharan Africa, southern Asia and South America. The most prevalent drugs worldwide were carbamazepine, used to treat bipolar disorder and seizures; the diabetic drug metformin; and caffeine. In 25 percent of the sites, the concentrations of pharmaceuticals were above the levels considered safe for aquatic life or above thresholds of concern for the development of antibiotic resistance.

Though the results suggest that pharmaceutical pollution in rivers poses a global risk to human and environmental health, further research is needed to determine just which of the thousands of waterborne drugs pose the most risk, and just how much exposure is too much for the general population.

On the topic of unused drug collection in terms of a preventive practice for proper disposal, Kolpin said there is insignificant data or studies that reflect that this is decreasing levels of drugs in waterways.

But overall, Kolpin said it is good practice to both minimize taking medications as much as possible – such as avoiding overprescribing antibiotics or overdoing it with over-the-counter pain medications – and taking unused and expired medications to collection sites for proper disposal.

“I have not seen any studies that would show before and after levels of pharmaceuticals in wastewater effluent since drug take back programs have been activated – and they’ve been around since the early 2000’s – but we know these programs can help. There is still no hard data, no percentage points to measure what improvement there is, but I will always tell people, let’s start with the easiest part of the equation: stop flushing unused drugs down the toilet.”

Kolpin added that even using a once-advised method of mixing unused medicine with things like kitty litter and putting them in the trash eventually make their way into landfill leachate. And even though landfill facilities must treat leachate before it heads to a municipal wastewater treatment plant, the drugs will still not be completely filtered out at that juncture.

“We cannot just keep doing what we have been doing and put all the pressure on our wastewater treatment plants,” insisted Kolpin. “They are our last line of defense. The problem needs to be addressed way upstream, such as greener pharmaceutical choices, curbing the overprescribing certain drugs, and even overconsumption of caffeine. We need to educate the public that everything we consume has the potential to cause environmental contamination, so we need to be smarter with our choices.”

Can we regulate ourselves out of our medicated water woes?

Christian Doughton, a retired supervisory physical scientist who worked in the EPA’s National Exposure Research Laboratory and Lawrence Berkeley Laboratory, University of California, Berkeley before retiring in 2012, thinks too much politics and corporate greed are standing in the way from vigorous regulations.

In 1999, Doughton published one of the first comprehensive academic papers on the impact of pharmaceuticals and personal care products in the environment, entitled “Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?”

“This publication became a seminal article in the field of environmental science,” Doughton said. “It spawned other fields of important research that have had major impacts on better understanding of human and environmental health. It fostered a much more expansive understanding of humans’ impact on the environment. This can be readily seen by the fact that pharmaceuticals and personal care products quickly led to intense interest in ‘emerging’ contaminants in the environment.”

Doughton said putting regulations on contaminants after they have been used for decades is a somewhat backwards approach, as people need to be first educated on their responsibility to how they are contributing to the degradation of the environment, and corporations, due to greed and the fact that regulating agencies do not weigh in the long-term polluting effects of products when they come on the market.

“There is an interconnectedness between humans and the environment,” he explained. “More than any class of pollutants, pharmaceuticals and personal care products highlight the intimate, inseparable and immediate connection between the actions, activities and behaviors of individual citizens and the environment in which they live.”

Doughton’s tenure at the EPA, which included policy setting, led him to believe that the country’s environmental regulatory system is broken because of politics and a “social welfare” system for big corporations which are loosely regulated in order to turn a profit.

“In our economic system, the consumer generally has no idea how much any given product actually costs them, and this includes the true costs of what nearly every product they buy will only reveal themselves in the future – sometimes over the course of decades, such as oil and chemical spills, and in perpetuity, such as nuclear waste.” He continued: “Even worse is that every person pays at least part of the cost of all products purchased by others – products that they never use or plan to buy. In this way, we are all complicit in the destruction of the environment and our health.”