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Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 10 - Evidence - April 3, 2014


OTTAWA, Thursday, April 3, 2014

The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:30 a.m. to resume its study on prescription pharmaceuticals in Canada.

TOPIC: The nature of unintended consequences in the use of prescription pharmaceuticals.

Senator Kelvin Kenneth Ogilvie (Chair) in the chair.

[Translation]

The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.

[English]

My name is Kelvin Ogilvie, and I am from Nova Scotia and the chair of the committee. I will ask my colleagues to introduce themselves.

Senator Seidman: Judith Seidman from Montreal, Quebec.

Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.

Senator Eaton: Nicky Eaton, Ontario.

Senator Seth: Asha Seth, Ontario.

Senator Enverga: Tobias Enverga, Ontario.

Senator Nancy Ruth: Nancy Ruth, Ontario.

Senator Eggleton: Art Eggleton, Toronto, and deputy chair of the committee.

The Chair: I want to welcome our witnesses. Today, I will identify you as I call you to present. I remind us all we are in the fourth phase of the four-part study of prescription pharmaceuticals in Canada. In this section, we are dealing with unintended consequences.

We have two witnesses both appearing as individuals. I will start with Wendy Krkosek, Research Engineer, Centre for Water Resources Studies, Dalhousie University, and I will ask you to present first.

Wendy Krkosek, Research Engineer, Centre for Water Resources Studies, Dalhousie University, as an individual: Good morning and thank you, Mr. Chair and honourable senators, for inviting me today and providing me the opportunity to address the issue of unintended consequences of pharmaceutical use, specifically, environmental concerns and removal methods during waste water treatment.

There are currently more than 4,000 pharmaceuticals in daily use around the globe. Pharmaceuticals are designed to elicit a biological response, and these compounds can be grouped into classes with similar modes of action; however, each compound is unique and could elicit different responses in non-target organisms.

Pharmaceuticals can enter the environment from both human and animal sources through a variety of pathways; however, my focus today is on human use pharmaceuticals and their fate in waste water treatment.

When pharmaceuticals are ingested, they are often not fully metabolized within the human body, leading to excretion and discharge of both the pharmaceutical and its metabolites into the waste stream. These compounds enter waste water treatment facilities where they may be fully degraded, converted to metabolites and conjugates, transformed to other products through chemical or physical treatment, or they can pass through the treatment plant unchanged, leading to their discharge to a receiving water. Biosolids produced from waste water treatment can contain adsorbed pharmaceuticals, and subsequent land application of biosolids can be another environmental source of pharmaceuticals.

The concentration of pharmaceuticals entering waste water treatment plants is highly variable but generally in the parts per trillion or low parts per billion ranges. This is thousands of orders of magnitude lower than therapeutic doses, and, to put this into perspective, if ibuprofen was present at 40 micrograms per litre, or parts per billion, which would be considered a high concentration, you would need to drink 10,000 litres of waste water to obtain a dose of a single pill.

However, the concern is not one single dose to humans but a sustained low dose to aquatic species for which the drug was not intended. Furthermore, waste water discharges may contain hundreds of pharmaceuticals, some of which may have similar modes of action and may act to produce synergistic or additive effects, complicating the situation to aquatic species in the food chain.

The environmental fate is also dependent on the receiving water. For example, the Grand River in Ontario has numerous drinking water intakes and waste water discharges as water flows through communities like Guelph, Kitchener, Waterloo and Brantford, with ultimate discharge into Lake Erie. During periods of low flow, a large percentage of water in the Grand River may be treated waste water. Thus the concentration of pharmaceuticals present in the Grand River would vary during low and high flow periods. The situation for the Grand River would also be similar to the Saskatchewan River in Western Canada.

Thus the presence of pharmaceuticals in the environment is very site specific and dependent on many factors, including demographics of the population served, receiving water characteristics and the extent and characteristics of waste water treatment processes.

Pharmaceuticals are generally designed to have a low acute toxicity; however, they are also designed to affect specific biological pathways. These pathways and modes of action may also exist in non-target organisms. As a result, many pharmaceuticals are not acutely toxic to organisms at the concentrations found in the environment and traditional toxicity tests often do not provide adequate information.

The long-term sub-lethal effects could be a much greater concern. A Canadian research team, led by Dr. Karen Kidd from the University of New Brunswick, conducted a whole lake study at the Experimental Lakes Area in Northwestern Ontario on the impacts of low-level exposure to EE2, which is a synthetic estrogen commonly used in the birth control bill, on the fathead minnow. EE2 was spiked into the lake at environmentally relevant concentrations and results showed that chronic exposure led to significant impacts on the reproductive activity of fish populations.

To conduct an array of ecotoxicity studies on each and every pharmaceutical and reaction product is a large, time- consuming and costly task. Researchers have proposed methods to streamline the approach based on the modes of action of a particular pharmaceutical, and targeting tests on organisms that would have a similar biological pathway. There could also be a role for the pharmaceutical industry in this respect during drug development. Requirements could be put into place for the use of bioassays during the development process to reduce the potential impacts to non- target organisms. However, even with this type of database, the picture of potential impacts is not complete as it does not include the potentially additive or synergistic effects due to the presence of mixtures of pharmaceuticals.

Historically, waste water treatment processes have been designed for bulk organics, solids and nutrient removal, and are not designed for trace organic removal, including pharmaceuticals. Despite this, existing treatment methods have been shown to reduce concentrations for some pharmaceuticals. Typical removal mechanisms include biodegradation, adsorption and transformation through disinfection. Removal varies in extent and type, based on the individual compound, the water quality, type of treatment and operational parameters. There are some general trends that have been observed for pharmaceutical removal. For example, ibuprofen is generally readily removed through biological processes, while antibiotics such as ciprofloxacin often have a high affinity for sorption to solids, and thus may become an issue in biosolids. Carbamazepine, which is an anti-epileptic drug, remains virtually unchanged through the treatment process. However, there is often large variability in removal between studies, and both within and between classes of compounds.

In addition to removal, some studies indicate higher concentrations of pharmaceuticals in treated waste water versus raw waste water, which is counterintuitive. Pharmaceuticals are sometimes excreted as metabolites or conjugates that can be transformed back to the parent compound during treatment. Adsorbed compounds can also be released during treatment to produce higher treated waste water concentrations, as has been observed for compounds like diclofenac.

The reactions of pharmaceuticals within waste water treatment through disinfection processes using chlorine, ozone or UV may lead to the creation of reaction products. Thus, removal of the parent compound may not indicate the removal of any potentially toxic metabolites or reaction products that have been formed. It is a very complex process to discover and characterize the toxicity of reaction products, a process that can take years.

There are two main ways that the release of pharmaceuticals and trace organics could be regulated. The first would be to limit the concentrations in effluent, and the second would be to limit and monitor the response of organisms in the receiving water and determine thresholds for action. In Canada, the Wastewater Systems Effluent Regulations, WSER, passed in 2012 will require all facilities over a specific size to treat to a secondary level standard, which generally refers to biological treatment. It is expected that one in four plants will be affected by these regulations, and the Canadian Council of Ministers of the Environment, CCME, estimated the costs of compliance in the ballpark of $10 billion to $13 billion. Secondary treatment will not lead to complete removal of pharmaceuticals.

Current sampling requirements of the new regulations cost approximately $50 per sample. The cost for testing a select number of pharmaceuticals would be upwards of $500 per sample. However, this assumes that there are a set number and list of pharmaceuticals that should be monitored and regulated, which to date has not been determined. Upgrading treatment plants for the removal of pharmaceuticals would require advanced treatment, and the cost to achieve this would be extremely high, given that upgrading Canada's facilities to only a secondary level will cost $10 billion to $13 billion.

Risk assessment and monitoring the response of organisms in the receiving water of the whole effluent, not single compounds, is another option. However, this comes at an increased cost, and there also needs to be a standard framework for evaluating response, which currently does not exist. With the greatly varying modes of action of the different pharmaceuticals, it is difficult to determine one response that would capture the toxicity of the whole effluent, and the question of which is deemed an acceptable response also arises. Are we only concerned with impacts to populations of fish, or do we also care about the impacts to bacteria and other organisms lower on the food chain?

In conclusion, pharmaceuticals excreted by humans enter the environment through waste water discharges. In general, waste water treatment is not designed for and does not lead to complete elimination of pharmaceuticals in the waste stream. In fact, in some situations, it can lead to increased concentrations due to conversion of metabolite and can also lead to the formation of reaction products through disinfection. The cost of designing treatment facilities specifically for their removal would be extremely high. A more likely approach is the use of site-specific risk assessments to determine whole effluent toxicity. This type of approach would also allow for future proofing for upcoming challenges of water scarcity and reuse.

To facilitate this approach, there needs to be a further consensus on what is deemed an acceptable response. Although much research has been done over the past 10 years on this topic, and we know now more than we ever have, there is still a lot more work required to understand the full extent and implications of this issue.

The Chair: Thank you. I will turn to Rebecca Klaper, Associate professor, School of Freshwater Sciences, University of Wisconsin-Milwaukee.

Rebecca Klaper, Associate Professor, School of Freshwater Sciences, University of Wisconsin-Milwaukee, as an individual: Thank you, honourable senators, for this opportunity to provide testimony to you on the concerns regarding the presence of pharmaceuticals in the environment and their potential environmental consequences.

I am associate professor at the School of Freshwater Sciences at the University of Wisconsin-Milwaukee, where my research over the last decade has focused on measuring the presence of pharmaceuticals and personal care products in freshwater systems and their potential impacts and, specifically, their impacts on the Great Lakes.

Pharmaceuticals have brought about radical changes in the way we treat ailments. We have now medications that allow us to change our physiology to impact everything from the ways in which our brains function, to hormones that are associated with reproduction. Many of the medications we take pass through our bodies either unaltered or slightly altered and end up in the waste stream, and waste water treatment facilities were not designed to remove these compounds, although they do remove them to some extent, as Dr. Krkosek was just explaining.

They also enter the environment through failing aging infrastructure, which we have in the United States, and I assume we also have in Canada, as well as through the use of waste biosolids as fertilizers and the use of pharmaceuticals in agriculture and urban settings. Agriculture has a huge consumption of pharmaceuticals, which is often underplayed.

Studies across the globe in the last two decades have indicated the presence of these compounds in our freshwater lakes and streams, which has brought growing concern not only from scientists but also from the public at large as more and more studies are published on the topic. The reason they have become a prominent issue only over the last decade is not due to their sudden appearance in the environment — the release of pharmaceuticals into the environment has occurred over decades — but is due to advancements in our technologies for measuring these compounds at the very low levels they are found in our freshwater systems. These technologies have allowed scientists such as me to measure low concentrations of these compounds that occur in the environment.

Since these compounds occur at low concentrations, well below what has been studied as a therapeutic dose for humans and many medical studies, it is unclear what impacts they may have, particularly on wildlife and organisms in the environment and processes that are important within our ecosystems, not just at an organism level. In the absence of information on these impacts and due to the public outcry regarding the presence of these contaminants, the major focus to date has been the removal via waste water treatment plants and through pharmaceutical take-back programs. However, research has shown that these are not a complete solution at the present time. The question to pose is whether there is something that we should do as a society to address this issue and what options are the best to pursue.

The three main points I would like to emphasize today are that, first, it is unclear as to the overarching impacts of the presence of these compounds in the environment to organisms and the ecosystem. However, we do know that there are indications that select compounds have impacts at the low concentrations that we find them and, therefore, are currently of concern. Second, we need to determine the best treatment technologies for removing the chemicals of greatest concern, in addition to examining issues related to our infrastructure. Third, the entire system of creation, use, distribution and disposal of pharmaceuticals needs to be examined to determine the best methods to minimize their presence in the environment.

We have found in our own research that various commonly used medications from antibiotics, anti-depressants and diabetes medications commonly taken by the public have been making their way into the Great Lakes, specifically, Lake Michigan. The concentrations found range from nanograms to micrograms per litre of water, a very small concentration that is 100,000 to 1,000 times less than the thousands of milligrams taken each day by a person who is one of these medications. The argument in the past has been that the concentration is too small to make any impact in the environment. This has also been the basis of previous laws and regulation regarding levels in the environment and testing required for the approval process for the medications.

This brings me to my first point. Although these medications have been detected globally in waterways, the overarching impacts of the presence of these compounds in the environment to organisms and the ecosystem are still unclear. Our investments in determining these impacts as a society are lacking, which leads to questions regarding potential solutions and the best investments. What we do know today, however, is that there are indications that select compounds have impacts at low concentrations and, therefore, there is cause for concern.

Some of these medications can work at very low doses, especially in organisms such as fish that have smaller body size and may not metabolize and get rid of these compounds as easily as humans do. For example, in my lab we have found that small doses of fluoxetine, the active ingredient in Prozac, can cause changes in fish behaviours related to reproduction and cause a decline in reproduction in these fish. Other labs have found similar results with other antidepressant compounds and have also found there are differences in the uptake of metabolism in fish versus humans. Hormones also appear to act at a very low dose, and there are some indications that the presence of birth control pill medications and hormones used in agriculture may disrupt reproduction in fish species in the wild.

When we examined the toxicology databases and scientific literature for data on the impacts of chemicals at the concentrations we found in Lake Michigan, we were able to determine that for a subset of the medications detected we had enough information to determine there was cause for concern, going from the sewage outfall to 3 kilometres away for a dozen out of the 50 compounds we measured. However, for a large number of these chemicals, we have little data and we cannot determine the impact of the levels we see in our waterways, including the Great Lakes. In addition, each chemical is part of a larger mix of compounds detected. We have found, as have others, that although a chemical may not cause an impact alone at a low dose, when it occurs in a mixture, there can be a synergistic effect, where the sum of the exposure to two chemicals is greater than adding up the response of each chemical individually. Data on the impact of mixtures is sorely lacking.

This leads me to my second point. There currently is no one treatment technology that removes all the chemicals of concern to zero. A summary by the U.S. Environmental Protection Agency of all the water treatment technologies available shows that each treatment is able to remove a portion of the trace chemicals, but none of them totally removes all of the compounds. Since none of them remove all of the contaminants, how can we best invest in treatments without some knowledge of the chemicals that should be targeted for removal? The question is whether the best mechanism to address the issue of pharmaceuticals is investing and implementing more and better treatment technologies. We cannot be sure this will solve the problem and, unless we have data on the impacts of these chemicals to know if we are targeting the right compounds for removal and whether they have been removed to the point they no longer cause impact, we are working with incomplete information.

In addition, we cannot completely address the issue without considering emissions from production facilities, hospitals, leaks in our aging infrastructure, agricultural runoff and runoff from spreading of solid waste from treatment facilities. This begs for the evaluation of multiple control tactics, not just waste water advances.

This brings me to my final comment, which is that we need to consider multiple alternative mechanisms for minimizing environmental harm from these chemicals, which includes not only investigating novel waste treatment technologies, but also evaluating a regulatory framework to increase the sensitivity of testing for potential of environmental harm. We should find ways to encourage environment assessment as we create these products.

The potential for overprescription for humans and agriculture should be evaluated, and the disposal of these chemicals, whether it's individual pills or through biosolids, need to be addressed.

Through research investment and determining the impacts of pharmaceuticals in the environment, evaluation of our current infrastructure and considering behavioural changes in relation to prescription and use of these chemicals, we can better address this issue.

I am thankful that this committee of the Senate is focused on the topic of potential environmental impacts of pharmaceuticals, and I thank senators for allowing me the opportunity to provide this testimony. I will be happy to answer questions.

The Chair: I will open up the floor for questions.

Senator Eggleton: Thank you very much to both of you for coming today and providing your knowledge of these areas, which is helpful to us in doing our study.

I did also note your comment about the concern about antibiotics and how they're used. Maybe I'll start with that, because we are being told by a number of organizations, including the World Health Organization and the CDC in the United States that, in fact, we're in a crisis position in terms of antibiotic resistance. We also know that the vast majority of antibiotics are used on animals, not humans. In fact, the majority of the ones that are used on animals are not used to help the animal get over a problem. They're growth related.

Then we've also heard that there are other products, personal products, like hand soaps. In fact, the FDA is looking at that, too, because all of these things have some impact on the environment.

I wonder if you can express that in terms of the water systems or the leaching from landfill in terms of the concern over antibiotic resistance and how that's all working in terms of the environmental impact.

Ms. Klaper: It's definitely of great concern. There are several researchers in Milwaukee addressing the issue of the presence of anti-bacterial resistance genes in natural populations of bacteria that are found in the Great Lakes and whether that ends up leading to issues down the line.

I think in the population as a whole, as you said, some of these medications are prescribed as prophylactics for livestock and end up making their way into our own food system because of that, and the bacteria do as well. It's definitely of great concern.

Antiseptics found in hand soaps, in addition to leading to potential antibacterial resistance, also have been shown to break down into dioxin-like compounds and so there is the additional problem of it creating a bigger problem than what you started out with. In fact, the State of Minnesota has banned the purchase of products that contain triclosan and triclocarban, the two main antiseptic compounds that are stuck into anti-bacterial products. The state is no longer purchasing anything that has those two compounds. I think other states, the EPA and FDA are also looking at those compounds as potential endocrine disrupters. The concern is justified, and people are trying to find a way to deal with that.

The Chair: Ms. Krkosek, do you wish to add anything?

Ms. Krkosek: No. I think my colleague answered that one quite well.

Senator Eggleton: Dr. Krkosek, you put in your submission that the cost of designing treatment facilities specifically for removal would be extremely high. I think you both said that, so it doesn't sound like that's the short-term solution; although, I take it there are some methods that could be used to mitigate to some degree.

I gather, from what both of you are saying, that you don't have to worry about all the medications, but there are some. In fact, Dr. Klaper, you said in your presentation that there are indications that select compounds impact at low concentrations and therefore are currently of concern.

How easy is it to identify those and who should be doing that? Is that government, the regulator? How can we get a handle on that? Which select compounds are the ones we should be looking at?

Ms. Krkosek: This is a challenging question and it comes back to what are the impacts we're looking at, and what are we deeming as acceptable responses?

In 2011 or 2012, the EU proposed 15 different pharmaceuticals to be added to their priority substances list. There was a lot of research that went into determining which of those compounds should be on that list. It came through that three of them were actually added. There were two hormones, EE2 and E2, which are both components of the birth control pill, and also diclofenac, which is an anti-inflammatory medication, added to the priority list, but I don't believe there have been any requirements yet for monitoring or regulation of those compounds.

Senator Eggleton: But they've been identified.

Ms. Krkosek: These compounds are of concern, and we should look further at these in the future.

Senator Eggleton: In terms of the water.

Ms. Krkosek: Yes, but there are a lot more out there as well, and that was one sort of EU perspective.

Ms. Klaper: In the United States, we have a similar list. It's the contaminants of concern list. I believe the hormones have been placed potentially on that list, but we have the additional problem where, without the effects information, those compounds are not regulated or put into a regular monitoring program. So we have the same kind of issue.

We do know that some of the psychopharmaceuticals, the antidepressants and anticonvulsants, act at a very low dose, and chances are they probably act similarly in humans, but we are usually looking at a different end point. So the low-dose effects we see in fish might mimic something we see in a human dose at the beginning. The hormones are known to act at very low doses.

We've identified at least two classes, but, as Dr. Krkosek mentioned, there are so many different pathways that trying to monitor for them all at this moment with the level of funding that's available for this type of topic is minimal.

Senator Eggleton: I read an article. It's a couple of years old, but it's from the Natural Resources Defense Council in the United States, and it actually outlined some thoughts on how we could improve. I won't go through all of them, but I will go through a couple.

It talked about improving drug designs. Drugs should be designed so that the active parent compound or its metabolites, if they are biologically active, do not persist in the environment.

It talked about tightening FDA approval processes, which in Canada would be Health Canada.

They also talked about disposal of pharmaceuticals more safely, the take-back kind of thing, which I take it is done in some parts of both countries but not everywhere. We had the pharmacists here. We're trying to get them to advertise it more. They'll take them back, but most people don't know about it.

Do you have any thoughts about those ways of helping the environment?

Ms. Klaper: The kind of redesigning the drug has been a movement. A ``green chemistry'' movement is what they call it, trying to consider the potential ramifications of all the products that go into the making of the pharmaceutical, as well as the effects afterwards. It's definitely a movement, but it hasn't caught fire. I think it is something that should be addressed in the future.

As far as the regulations, right now in the United States, where they stand for pharmaceutical companies going through our regulatory process, if a compound is not thought to occur at level of above one part per billion in the environment from models that the companies do, they're not required to do environmental testing on the chemicals. What we know from the research we were just discussing, the hormones and some of the psychopharmaceuticals act at a lower dose than that. It would be a good idea to revisit those.

As far as take-back programs go, they are important, but, as I said in my statement, that's a very small part of the larger issue of the way we prescribe medications and the way we deal with the waste from that prescription process.

Ms. Krkosek: I would echo the same sentiments. As we mentioned, because there is no way to really eliminate these compounds through waste water treatment, I think source control is an important part of the process. There is definitely a role to play in sort of the green chemistry, and possibly in more bioassays being developed at that level before the pharmaceuticals are approved, but we need to know what those responses are and what we are actually looking for.

Senator Eaton: In your view, should pharmaceutical pollutants be approached separately from the environmental pollution from personal care products? Is that part of your research, or is it strictly pharmaceuticals?

Ms. Krkosek: They are often linked together. In terms of source control, there are different issues.

On the pharmaceutical side, there can be some source control on drug development and things like that, and on use and prescriptions and ensuring that prescriptions are given at appropriate doses for appropriate uses. But on the personal care products side, that's consumer choice and I think that's a lot more difficult to control. There could be some mechanisms for source control on the development of those products as well.

Ms. Klaper: I would agree with those statements.

Senator Eaton: When you talk about investigating novel waste treatment technologies, I'm thinking of cattle, I'm thinking of gardening products, I'm thinking of the fact that if we take drugs they go through our digestive systems and out. We can't change that.

How much investigation are you doing with things like plants and swamp waters to filter water? Have you seen the things they're doing in England where they use plants and water to filter?

Ms. Krkosek: Wetlands are definitely a form of waste water treatment used in a variety of communities. There have been studies done on the removal of these types of compounds through wetlands, and they are the same types of processes. It doesn't remove everything. There are absorption processes and biodegradation processes that are happening, but, again, it's not complete removal through that type of a process. It definitely helps, but it's not complete removal.

Ms. Klaper: I would also say that's not necessarily an answer for a large urban area, which is where you end up getting a lot of waste. There is no place to put a wetland big enough to treat the volume of waste that goes through there.

Senator Eaton: I was thinking of farms and smaller communities. Do you have percentages of what enters the water system that is people throwing out their pills and or going through people's digestive systems? We can stop or discourage people from throwing their pills down the toilet, but there are other things we can't stop.

Ms. Klaper: That's really the million-dollar question. A lot of people are trying to answer that. It's a very difficult question to answer. From a monitoring standpoint, trying to monitor the breakdown product of what happens in the human body, but what happens is it goes to the treatment plant and the bacteria end up sometimes changing the compound back to the way it was originally. It's hard to track what's coming in —

Senator Eaton: That's raw and what's coming through digestion.

Ms. Klaper: Exactly. There have been people who have tried to model those two and have come to the conclusion that a lot of it is probably us taking our medications.

I don't know what the take-back programs are like in the United States. I participated in one in Milwaukee where we actually counted pills that came back, and we're in the process of publishing that. People hold on to their medications for a very long time. I think a lot of people don't flush them down the toilet. They're still sitting in their medicine cabinet. The oldest medication that came back that year was from 1963. I don't know how common it is to dump down the toilet.

Senator Eaton: Is there a difference between flushing medication down the toilet and putting it in the landfill? Does it act the same way in the landfill as it would flushed down the toilet?

Ms. Krkosek: It would enter a different process. If it's dumped down the toilet it goes through a waste water treatment process before discharge to water.

In a landfill, depending on the landfill, most modern landfills are lined and they have a leachate collection system which often has some form of treatment as well, but it would be a different treatment because you're dealing with a totally different waste stream.

Senator Eaton: So there's not one that's safer than the other?

Ms. Krkosek: Not necessarily. They're very different streams, and I'm not very familiar with the literature on treatment of pharmaceuticals during landfill leachate.

Senator Stewart Olsen: Thank you, ladies, for coming. That's very informative. It raises a lot of questions, I agree with Senator Eggleton, but I'm just going to concentrate on a couple.

Rural areas in Canada are where a lot of us get our drinking water, and a lot us get our drinking water from wells and use septic systems. Have you done any studies on the safety of water individually in wells? I know that it's all the same water table, same aquifers and everything, but would that be safer, in your opinion? I don't know if there's a study.

Ms. Krkosek: That's also a very complicated question. Aquifers are very complicated places. It depends on whether it's a shallow or a deep aquifer, and whether there are contributions from surface water, and whether you would have water filtering through a riverbank, perhaps, into an aquifer. In situations like that, where you're exposed to surface water sources, there could be potential for these contaminants coming from that way. But if you have a deeper aquifer that's not connected to the surface, the chance of having these compounds is a lot lower.

From a waste water treatment perspective on site, there are some studies done on septic systems and they are the same types of processes that we've talked about, and it's not complete removal of all of these compounds.

Senator Stewart Olsen: Have you done the same studies on salt water as you have done on fresh water? I'm interested mainly because of the fish and because of fish farming. Do you sample close to fish farms, or do you think it would be a good idea to do more frequent sampling around fish farms?

Ms. Klaper: I haven't in particular, due to our location on the Great Lakes, but there are colleagues of mine who do regular sampling out in saltwater systems, and we see the same kind of presence and potential impacts in saltwater systems that we do in freshwater systems.

With regard to fish farms, I guess it's a two-part question. There are a lot of medications used in fish farms, and people have monitored some of the antibiotics and hormones and things coming off of fish farms, and they do end up going into the water system. But it is possible that those fish farms, if they're located downstream from a waste water treatment facility or an agricultural run-off area, are also receiving some input.

Senator Seidman: Thank you very much, Dr. Klaper and Dr. Krkosek, for really good presentations that give us a lot to think about, from your professional expertise, which is very critical here.

You both talked about the synergistic effect and the importance of recognizing that when it comes to these pharmaceuticals, and then you both also talked about measuring and surveillance. I'd like to ask you a bit about those particular aspects, if I might.

There are various entry points of these pharmaceuticals to our environment, and the waste water treatment plants are only one, as you've said. There are also leaching into groundwater via landfill and storm water overflow.

In your view, based on your experience in the United States, Dr. Klaper especially, should there be some kind of environmental surveillance through our environmental agency to measure the impact on these three access points?

Ms. Klaper: The global answer, I would say, is yes. I would say we definitely need some more monitoring tools for the impacts of these events, as you're talking about.

I think in the United States the U.S. Geological Survey performs that function somewhat, but they're not able to do it for every stream. As Dr. Krkosek was saying, it's very site specific as to the types of contaminants you're going to get at each location. Even having a broad monitoring program, where you're looking at potential major inputs in locations maybe that have a diverse type of make-up of compounds I think would be a good first step for monitoring programs.

Senator Seidman: Dr. Krkosek, I believe it was you who said that there is no standard framework for evaluating the response in our environment. Could you please elaborate on that?

Ms. Krkosek: Yes. Because there are so many compounds and they have so many modes of actions and biological pathways, and because there are lots of different organisms in the receiving water, it's really challenging to determine what impacts these compounds are having singly and as mixtures on all of the different organisms at different levels.

So it's a very complicated issue and, at this point, there is a lot of research going on into a variety of these different aspects. From what I have seen so far, there hasn't been one perceived approach moving forward in determining what the impacts are that we need to measure and what the compounds are that we really need to focus on, because it is a really complicated issue.

Senator Seidman: So, the surveillance aspect and the measurement aspect are critical.

Dr. Klaper, you said evaluating our regulatory framework to increase the sensitivity of testing for potential of environmental harm is one proposal, because we need to consider multiple alternative mechanisms.

I'm sure, Ms. Krkosek, you agree with that. We are a Senate committee; we are trying to understand the proposals and make recommendations. How can the regulatory framework become more sensitive to this and further the process in alleviating some of these problems?

Ms. Klaper: I would think requiring some environmental testing to be done regardless of the anticipated models of the concentration that might go out in the environment. We do have standard ecological assays where you could, at least on a gross level, tell whether reproduction has changed in a fish, for example, whether over a chronic period of time there's going to be some impact. Those chronic effects are really important.

As was mentioned, the acute toxicity is not really the issue. The issue is the low-level exposures over a longer period of time.

For instance, in the United States there has been a huge focus — and in Canada as well due to the work of Karen Kidd and others — on endocrine disruption and endocrine disruption screening. We have some batteries of tests that have gone towards not only human-type assays but fish as well that answer some of the questions about endocrine disruption.

There is some development of assays that are critical, but it seems like having some ecological testing that is required for the drug development phase seems logical.

Ms. Krkosek: In my testimony I talked about the waste water system effluent regulations which were put into place last year. Earlier versions of those regulations had components of ecological effects monitoring within the regulations, but those were taken out in the final version.

I can't remember the exact details on what was involved in the ecological effects monitoring, and I know that acute toxicity is still a component, but there was a little bit more to it in the earlier phases.

Within the Canadian Council Ministers of the Environment, which was the original study done on the municipal waste water strategy, there was a component on receiving water risk assessment. So that was there originally, but I'm not sure what the reason was that that was taken out. However, it is an extra cost that's added to the compliance of an already very expensive program; but there was something there originally, and I do agree that that's something that would be worthwhile.

Senator Seth: Thank you for such a great informative session. What has been going on is very complex, no-win situation.

Recently you have told us about two dangerous pharmaceutical chemicals, EE2, which is synthetic estrogen, and another which is antidepressant medication drugs. If it is chronically used, it has an effect on the reproductive system of the fish. Are there the same reproductive effects on human beings? Have you done any trials of that?

Ms. Klaper: Fish are often used as a model, especially for development of humans. We have very similar pathways. So one of our questions in our lab is, how could this impact the behaviour of humans at very low doses, and also how does it impact human development if, let's say, a mother is taking a medication such as an antidepressant? We do have some of those questions.

People get concerned about drinking water, in particular, if some of these chemicals are coming back through our drinking water. The levels that are coming back are very low and, to be honest, for a lot of the chemicals, the pharmaceuticals and personal care products we're using in our daily lives, the exposure is our own fault. We're taking our medication, we're rubbing lotions on ourselves, and that's our major exposure route for a lot of these things.

Senator Seth: Can you discuss about the research currently under way with respect to potential new technology for the waste water treatment? Can you tell us about that?

Ms. Krkosek: Sure. Traditionally there is a very standard conventional approach to waste water treatment. Recent advances in waste water treatment have looked at a variety of different options, some of which include membranes, so a physical screening; and membranes do have a better success rate at the removal of pharmaceuticals, but they are also a very expensive technology. For waste water treatment you can't use a very small pore-size membrane because of the amount of stuff that's in that waste water. The cost associated with a lot of these new technologies is also prohibitive in a lot of senses for actual implementation.

Some of these new technologies do show promise in the removal, but it's going to be a long time before every treatment plant adopts these technologies.

Senator Enverga: Thank you for your presentations.

With regard to sewage and controlled waste management, there is control of the municipal, provincial and federal. I mean, have you seen anything that would hinder your work or make it better? Have you seen any policies that we should introduce to make those three more compatible with each other?

Ms. Klaper: The take-back events — in the United States, anyway — are often at a municipality level. In fact, our sewage district has been very involved in some of our take-back events. They bump up against our federal regulations for controlled medications where it has to go to a law-enforcement official. I don't know if you have the same regulations here.

There's been some stopping and starting as far as how effective that can be as a control not just for environmental effects, but also the medications falling into the hands of people that are selling them illegally or taking them and overmedicating themselves. It's hard to just go and drop off things. So trying to lay a framework where there's an easier mechanism for those take-back events would be one thing.

As far as the treatment technology, it is more at a municipal level, but the funding for infrastructure changes and for some of the larger policy changes that need to happen have to happen at a larger level for those municipalities to justify the expense to create new infrastructure and to create new technologies and monitoring programs.

It really is a large interplay between the larger and the smaller.

Ms. Krkosek: I can speak to how waste water treatment works at the provincial and federal level, and that is that it's regulated on a provincial basis. Environment Canada, at the federal level, has set the standards through the new regulations.

I know there's definitely some challenges at the provincial level on how to actually implement those new regulations and how enforcement should happen, and I think those are a lot of the discussions that are happening right now between the provinces.

I think the next few years are going to be really telling in terms of how that relationship unfolds.

Senator Enverga: I know you've been looking at the U.S. and Canada, basically, but have you ever checked what other countries are doing? Are they any better than us? Have we made any progress better than them? Could you let us know if you have seen those things happening in other countries?

Ms. Klaper: The Europeans have definitely been trying to address this issue as well. There are some medications in certain, select countries that have been taken out of circulation because of their potential effects.

Carbamazepine is one that is not prescribed any longer in certain countries, and there are behavioural changes. However, a lot of countries are in the same boat. We all have the same treatment problems and policy issues. We have medications that are ultimately beneficial in one way or another, otherwise they wouldn't be out in society. Trying to deal with the ramifications of everyone using these is a global problem.

Senator Enverga: Have we learned anything from any other country? Is there something that we should adopt that they have adopted there? Is there anything we should do to adopt some good qualities?

Ms. Krkosek: I'm not very familiar with the other policies, but everybody is working on this issue together and, through the research, everyone is looking at their neighbour in terms of what's being done and what should be done.

Senator Cordy: Thank you to the witnesses. This has been excellent testimony from both of you and we very much appreciate it.

We're on the cusp of learning a lot about it, because in reality it hasn't been long that we've been studying the implications of what's happening to our water system, so how far along are we going?

Dr. Klaper, you said it's unclear on overarching impacts, and Ms. Krkosek you said the picture of potential impacts isn't complete. First, are we starting to get there? How aware is the general public about what's going on? When I hear that the percentage of a contaminant in the water would be small, generally that's followed with ``but it won't impact human consumption.''

You've both spoken today about the impact on the fish in the water and, one would have to guess, the plant life. How far along are we? How clear is the picture becoming? You've presented a pretty clear picture today. Does the public have a good understanding of the impact on the water, the life within the water systems?

Ms. Krkosek: I can maybe take a stab at the second part of that question.

I think that public perception of this whole issue has been interesting over the past 10 years because people hear ``there are drugs in my water'' and they get very scared. There is some misconception on the levels of these compounds and the potential impacts that they would have on human health. People generally do get really scared when they hear there's anything in their water.

The focus is not necessarily a direct human health issue from the consumption of these drugs within the environment, but more on the ecological side. There could be more effort put towards educating the public on that aspect.

Ms. Klaper: As far as how clear the effects are, I think we're still at the beginning of trying to get a handle on how to study the impacts, but we've made some headway in the last 10 years that I've been involved in this field. More and more studies are coming out and people are generating ideas about how to deal with the hundreds of chemicals that might be out there, and looking at specific pathways that are important.

When we look at human health, we often are interested in the individual, but for fish, for example, we're interested in populations of fish. If you're interested in whether a population of fish is going to crash, you see whether reproduction changes. If we look at reproductive pathways and chemicals, it often provides us a lot of information. I think we're getting there.

Senator Cordy: I think you both made the point that it's often combinations. It's not just one drug, but how it combines with other drugs can affect life on the waterways.

It's changing somewhat, but when people have heard it's in the water they make a mad rush to buy bottled water. Have you examined bottled water? Is it any different than the water that's coming out of our taps in terms of the contaminants that may be in there?

Ms. Klaper: There have been a couple of studies looking at bottled water. A lot of the bottled water comes from municipalities that have the same issues with trace contaminants coming through. It's not necessarily a better solution and I think it's a misperception that it's cleaner, better water, not to mention it's in a plastic bottle that is leaching things into the water.

Ms. Krkosek: To add to that, in Canada bottled water is treated as a food product, not as a drinking water source. So the requirements for treatment and monitoring are not as strict as they are for a drinking water utility.

Senator Cordy: So the drinking water is not looked at as closely as bottled water because it's not —

Ms. Krkosek: It's not regulated as a drinking water. It's regulated as a food source.

Ms. Klaper: It's the opposite. Drinking water is regulated more than bottled water.

Senator Cordy: That's interesting. Thank you.

Senator Stewart Olsen: Listening to you, I begin to wonder if perhaps we shouldn't be putting more energy into treatment at the basic household level, rather than waiting until it gets into the main waste. If we had some kind of method, new housing developments could be mandated to put some kind of system in place. I know it would cost more, but in the end I think it might cost a lot less. Just because of the difficulties — and you've been studying this for 10 years — I'm wondering if maybe we shouldn't shift the focus. Rather than saying bring your pills back and let's do this, maybe we should be looking at individual households and some kind of system that would purify the waste. What are your thoughts on that?

Ms. Krkosek: I think it's a really great idea. Decentralizing waste water treatment is what we would call it, and having treatment at the household level.

One of the main challenges is that it puts the onus on the homeowner to ensure that everything is operating properly and from a human health perspective that could become a very big challenge.

Senator Stewart Olsen: I would say it would be complementary, but it is also a way of saying to people you that have to be very careful about what you're putting into the system.

Senator Enverga: We're talking about how to prevent people from dropping unused or expired medicines in the toilet, or something like that, but I was thinking that I see all these medicines with labels such as ``eat with food'' or ``take on a full stomach.'' It is maybe advisable to have them put a sticker that says do not throw in the water or the toilet, and maybe put a little picture that shows a dead fish floating or something like that? Would that be able to help us?

I know we have a lot of these pills, and they're all expired. How do we ask people to not throw them in the water? Do not throw them in the regular garbage. Labelling might work. What do you think of that?

Ms. Klaper: I think that is a great idea. As you mentioned with the prescription bottles, it seems like it wouldn't be a big of deal for Walgreen's or someone to put a little stamp on there. But you need to provide information for people about what you do with the medications afterwards. At the take-back events I've been to, people bring in all sorts of things.

You'd have to label an awful lot of things. We've gotten big jars of vitamins. I'm not as worried about vitamins going down the toilet. If they are out there in nature, they would potentially get eaten up by the critters out there that need the vitamins as well. They're natural compounds.

We also have shampoos and all sorts of random things coming back. You might have a little more difficulty with the unprescribed medications.

Senator Enverga: The labelling might help.

Ms. Klaper: It's a great idea and it would be relatively easy to add that to a label, I would think.

Senator Seth: What happens to these expired medications? Are we not supposed to give them back to the pharmacists? How do they dispose of them?

Ms. Klaper: I'm not sure what happens in Canada. In the United States there are select places for incineration of those medications. There is a plant in Indiana, and one in New Hampshire. During the events, or if pharmacists are responsible in that community for taking it back, it all gets shipped to those incinerators and gets burned. That's how it's disposed of.

Some organizations are trying to develop alternative ways of disposal practices that are basically on-site destruction, and I'm only guessing that those would be acid or something else that would destroy the chemical.

Senator Seth: Another alternative method is, just like you get the vaccine and vaccines are sent back to the health department — those all go back — why not send these expired medications also to the pharmaceutical companies and they should be able to dispose of them? Previously, it used to be that we used to throw it in the garbage. It was very dangerous. Now it is a special box where it all goes. No one else is distributing infectious disease. Why can't we do these small things?

Ms. Klaper: I agree. It goes to my third point about changing the behaviour, closing that loop, and sending it back and having the pharmaceutical company be responsible for the waste. It would be an interesting concept.

The Chair: On that last point, we heard from the pharmaceutical associations that there are very strict regulations with regard to the handling of returned pharmaceuticals for obvious reasons. You might want to rethink the idea of sending them back to the pharmaceutical companies, because they sell those pharmaceuticals. The idea of the regulator is to ensure that any returned material is actually destroyed, so there are very significant regulations with regard to collecting unused pharmaceuticals. We had testimony to that effect.

I'd like to thank you both very much. You're putting these things into an overall perspective. There are several levels to that perspective that you have described here today.

Dr. Klaper, I thought you made an interesting point when you said, ``After all, the original pharmaceutical we consume in some large quantity'' and when we identify it in the environment, it's in the nano-gram or microgram level. So we have to put it in perspective in terms of the human issue. On the other hand, there are the environmental organisms where their susceptibility might be at a much lower level than ours.

Second, you both referred to the synergistic potential of these at low levels. That's also an issue at the macro level in the pharmaceuticals. We are studying unintended consequences, and one of those unintended consequences is taking large amounts, relative to what you're speaking about, together because they have been prescribed, because you have multiple symptoms. We have been trying to pursue a way to get a much higher level of reports of the reactions to pharmaceuticals as a means of identifying this.

If we just think about that, if it's very difficult, up until now at least, for us to get any significant response — meaning the collecting of data — on the adverse reaction from a pharmaceutical in a deliberately prescribed medication to an individual, then the idea of how we survey the environment and get an overall consequence — it puts it in perspective in terms of the magnitude of the problem which you have expanded upon today. At the same time, we have to keep it in perspective in terms of what we're dealing with.

With regard to the issue of this, and if you think about what's going on in the world today with the massive computing capabilities emerging — cloud computing and so on — it may well be that some of these very large environmental issues may be able to be factored into data within those systems and somehow interrelated in terms of looking at the overall consequences. Again, as you have mentioned, the consequence in one micro-ecosystem may be very different than another. So we have all those complications.

The final thing I wanted to mention picks up on what I think Senator Eaton asked about; namely, the idea about the individual treatment. I am aware of technologies, particularly one being developed in Canada that's now actually being rolled out, that deals with the treatment of waste in what are called ``isolated communities.'' An individual household is an isolated community. A ship is an isolated community. In fact, a hotel is also. With their technology, in the particular product I understand they're rolling out now, one unit handles about 250 people daily.

I bring it up because their water treatments — and there are other treatments being developed in small levels that deal with various oxidative treatments, whether ozone or other forms, that actually destroy chemicals very well. Some of these kinds of processes are leading to almost complete — you can never eliminate completely. Once, we would have considered a nano-gram quantity nothing. Today, you're looking at that in terms of considering it as an environmental issue and how they interact at that level. So I'm not suggesting they can eliminate everything, but they are going beyond those levels in terms of the elimination of material.

It may well be that, if these kinds of processes that started this level — because it's not unimaginable to say that if a company can deal with a product that will deal with 250 people, they might be able to sell at the local garden store a unit that will handle a domestic unit or so on. Then, from the experience they learn there, they move forward. Of course, in time, humans seem to have a way of answering most of the questions.

On behalf of the committee, I want to thank you for describing your work, because the information you are gathering will be extremely important in terms of informing how various technologies might well apply or be adapted to the very issues you are identifying and being able to move forward. However, what is really important is to get it back and keep it in perspective as we move forward, collecting the data that you have identified, and ultimately dealing with the potential synergistic impacts.

On behalf of the committee, I want to thank you both for providing us with a fascinating view on this topic that we have been covering.

(The committee adjourned.)