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Remarks for Benjamin H. Grumbles
Assistant Administrator for Water
U.S. Environmental Protection Agency
at the Carolina Environmental Program 2006 Symposium
Safe Drinking Water: Where Science Meets Policy
Chapel Hill, North Carolina

March 16, 2006

I want to thank the organizers for inviting me to speak here today. I only regret that my schedule did not permit me to attend the sessions being presented. From reviewing the agenda and associated abstracts, I can see that many of them are very relevant to issues that we are dealing with at EPA and of interest to me personally. At EPA we are continually reminded that we need to use good science to make good decisions. In part, this is because our Administrator, Stephen Johnson, is the first career scientist to head the Agency. But, more importantly, it's because we know it's the right thing to do.

Clean and safe water are key ingredients to keeping people healthy. 100 years ago this nation still suffered through major outbreaks of disease and endemic illness from contaminated drinking water. Advances in water treatment throughout the last century had a tremendous effect on improving public health in the United States . Some studies have estimated that access to clean water was responsible for reducing mortality by half in major cities. Reductions in mortality for children and infants were greater - as much as three-quarters.

Today, although we still see some outbreaks, we are fortunate to have one of safest water supplies in the world. Unfortunately, for much of the world's population, illness and mortality from unsafe sources of drinking water are not a thing of the past. Here in the U.S. , we will never return to those days of the early 1900's, but we know there is still work to be done to maintain the gains we have made in the face of new and continuing challenges.

We cannot lose sight of the successes we have had in protecting public health, but we likewise must not lose sight that we still face challenges, including aging infrastructure, emerging contaminants, availability of water, and watershed protection.

The subject matter for your conference – Where Science Meets Policy – is an important one. Certainly science has been critical for helping us to understand where drinking water is threatened and how it should be treated to make it safe.

But there are some important questions in understanding how we can make the best marriage of science and policy. For example, what is the appropriate role of science in policy making? How can policy makers sift through numerous and sometimes conflicting studies? When it comes to building a case for a policy decision or regulations, how do we know when we have enough science to make a decision? And are there some things that we must do because we believe they are true, but cannot prove?

A few years back James Gleick noted in his book, Faster - The Acceleration of Just About Everything , that the “real time transmission of data has been a twentieth century obsession, fed by a parade of new technologies”. Our world would appear to be getting smaller and, although it could just be a function of getting older, for me at least, it does feel like time is rapidly accelerating.

New information comes at us fast and furious from many different directions. There are thousands of science journal articles published annually. Researchers are competing for research funding and therefore have a stake in ensuring that their findings are relevant and seek an outlet.

Competition amongst news outlets is even more intense. Although the news cycle is much shorter than it was even 10 years ago, every time findings from a new science study are published, policy makers are asked to respond. Even the public can be confused from the onslaught of information.

For example, how many of you here have been confused by conflicting advice about what we should or should not eat to avoid adverse health effects? I can understand the frustrations of many women who read this lead paragraph in an article published a little over a month ago in the Washington Post:

“Low-fat diets do not protect women against heart attacks, strokes, breast cancer or colon cancer, a major study has found, contradicting what had once been promoted as one of the cornerstones of a healthy lifestyle.”

A follow up article cited Jacques Rossouw, who runs the Women's Health Initiative as saying:

"I can see how a lot of women might be confused. People would like very clear results with a very clear health message, and, unfortunately, these results are not very clear."

One of my big challenges is working to develop a process for regulatory and policy affairs that can operate outside the influence of media and political pressure, so that we are not reacting to the big news story of the day, but are instead evaluating science and making decisions that address the greatest threats and allow for the greatest risk reduction.

Science vs. Policy

So, what are science and policy anyway? A visit to the dictionary tells me that science is knowledge or a system of knowledge covering general truths or the operation of general laws especially as obtained and tested through the scientific method and concerned with the physical world and its phenomena. And policy is a plan or course of action, as of a government, political party, or business, intended to influence and determine decisions, actions, and other matters.

They are not the same and we shouldn't confuse the two. Michael Leavitt, our previous Administrator and now Secretary for the Department of Health and Human Services, underscored the need to differentiate science and policy with a specific En Libra principle: “Science for facts and process for priorities.” It's important to understand that we must focus on the best available science to help inform policy, but science will not necessarily define the policy. Policy must take other factors into consideration. For example, in the Safe Drinking Water Act, we are required to take economic factors into considerations as we set drinking water standards. A good example is the drinking water standard for arsenic.

EPA has set a health goal for arsenic in drinking water at zero because it is a carcinogen. Our maximum contaminant level is set as close to that goal as is feasible for large water systems. In evaluating arsenic, we determined that it was feasible for large systems to reduce concentrations in drinking water to 3 parts per billion (ppb). The Safe Drinking Water Act allows the Administrator to move above the feasible level if justified by the costs.

We determined that most of the water systems affected by arsenic were smaller systems, which can face affordability challenges due to economies of scale. After careful consideration of costs and benefits, particularly for small systems, we determined that the costs would not justify the benefits obtained at 3 ppb. Therefore, we made a policy decision to establish a final MCL of 10 ppb, which we believe maximizes health risk reduction at a cost justified by the benefits.

When setting policy, our job is to be clear about our rationale for selecting that policy, particularly when it deviates from what science alone would suggest.

Regulating Contaminants

As I noted earlier, one of the challenges we have is sifting through all the information to determine where action is really needed. I empathize with researchers who want to be relevant. A scientist may carry out a cell culture study that shows adverse effects upon exposure to a contaminant, and may posit that, based on this finding, EPA should issue national drinking water regulations for that specific contaminant. However, it is impractical to believe that EPA can regulate every contaminant, particularly if they do not frequently occur in public water systems.

In determining whether a contaminant should be regulated the law directs us to consider whether the contaminant will have an adverse effect on health and occurs, or is likely to occur, in public water systems - taking into consideration both the frequency of occurrence and concentrations. These are essentially science questions. However, the law also directs us to ask a question which considers science, but it essentially a policy question – would regulation, in the sole judgment of the Administrator, provide a meaningful opportunity for health risk reduction for persons served by a public water system based on best available public health information? EPA needs to consider all three questions when making a regulatory determination.

But before we can determine whether a contaminant should be regulated, we need to develop a process that can objectively assess information to help us identify the highest priority contaminants on which we need to focus our research efforts. I want to spend a few minutes talking about how EPA has regulated contaminants in the past and how we are approaching it for the future.

In the past, EPA primarily regulated the contaminants that Congress required it to regulate by naming them in the statute. For example, the 1996 Amendments to the Act named a number of regulations that EPA was required to address – including changes to the 50 ppb standard for arsenic in drinking water. However, the Amendments also established a new framework for how the Agency would select future contaminants for regulation.

The law requires EPA to publish, and periodically update, a Contaminant Candidate List, or CCL, of unregulated chemical and microbial contaminants that are known or anticipated to occur in public water systems, may have adverse health effects, and may require regulation. On a second, staggered cycle, we are required to evaluate available information for those contaminants to determine whether or not to proceed with a regulation.

The first CCL, published in 1998, was developed based upon a review by technical experts of readily available information for four priority areas in drinking water research (occurrence, health effects, treatment, and analytical methods). The first list contained 50 chemical and 10 microbial contaminants/groups. We completed the first regulatory determination process in July 2003 and determined that there was enough information to decide that 9 of the contaminants did not need to be regulated. The remaining contaminants were carried onto a second CCL which was published last year.

However, after developing the first CCL, we recognized that we needed a more robust and transparent process for identifying and narrowing potential contaminants for future CCLs. We requested advice, first from the National Research Council and later from the National Drinking Water Advisory Council, on developing such a process. Both the NRC and the NDWAC recommended a broader, more comprehensive screening process to assist EPA to identify those contaminants for which further research would be appropriate.

We are currently preparing to implement some of the recommendations for developing our third CCL list, which we are kicking off later this year. Our challenge is that there are thousands of chemicals and we must narrow them down to identify the ones where regulation could present a meaningful opportunity to protect public health.

Our general approach will be to consider a “universe” of contaminants, which we estimate will number in the thousands. We will then consider available data to develop a Preliminary CCL which includes contaminants that occur, or have the potential to occur in drinking water AND cause, or may cause, adverse health effects. Finally, we will further consider the health effects – looking at the potency and severity – and the occurrence – looking at the magnitude, prevalence, and persistence/mobility – to develop a final CCL. We're developing screening tools that will be able to objectively review data and prioritize the contaminants.

We will still seek input from experts and stakeholders to identify contaminants that should be included in the contaminant Universe and the Preliminary CCL. But we are hopeful that our iterative, adaptive management approach will allow us to focus our efforts on the contaminants that are most critical to regulate for public health protection rather than those that are generating the greatest media attention.

Other Ways

Although we believe that the listing and screening process I've described will help us to make better decisions, I can acknowledge that some people might believe that it represents an approach to delay decisions. Certainly there are cases where we have data to indicate that there may be a problem, even though we may not yet have all the information we need to determine to move forward with regulation.

I agree that, in the absence of enough information to justify mandating a federal regulation, it is unacceptable to do nothing. But given the financial impacts of regulation on both businesses and individual households, we cannot regulate without having sufficient data to answer those three critical questions I referred to earlier.

So, where does this leave us? We should not back ourselves into a corner whereby we believe that regulation is the sole solution to ensuring environmental and public health protection. We all have a responsibility to act as stewards of our environment. Indeed, environmental stewardship is a key priority for Administrator Johnson and myself. I'd like to talk about pharmaceuticals and personal care products (PPCPs) as an example of where I believe that stewardship activities can reduce potential risks in the absence of enough information to justify drinking water regulation.

PPCPs in the environment are principally a source problem. They don't occur naturally, they're introduced by man. We are focused on carrying out research across EPA to gather information on potential adverse environmental and public health effects from exposure to PPCPs, analytical methods for detection, and occurrence in wastewater, ambient water, fish tissue, and biosolids. But quite frankly, I believe we are years away from having the kind of information needed to justify regulating PPCPs in drinking water.

Which brings us back to the source. We're coordinating with federal partners and reaching out to industry and stakeholders to encourage voluntary actions to reduce loadings to the environment – basically reminding everybody that they are stewards of their environment. There are opportunities to reduce loadings by moving away from agricultural use of drugs that promote animal growth, promoting drug recycling programs, ensuring that drugs are properly managed in hospitals and health care facilities, and encouraging pharmaceutical companies to reduce impurities within their products that can enter the environment.

We will of course continue to include and evaluate PPCPs in our contaminant selection process and carry out research efforts to determine whether regulation is necessary, but we cannot lose sight of the fact that there is more than one way.

Identifying Research Needs

As I said earlier, we need the best science we can get to inform our policies and regulations at the federal and state levels. Basic research is very important, but it's also important for scientists to be responsive to specific research needs that have been identified. This can be a challenge for the researcher whose focus is very specific – we need scientists to be able to shift their focus to investigate areas where additional information is needed.

With respect to drinking water, we need research in many areas, including health effects of contaminants, source water protection, drinking water treatment, security of critical infrastructure, and methods to monitor for and detect intentional contamination of water systems. We are working closely with our Office of Research and Development to identify research needs in anticipation of decisions that will need to be made in the coming years.

One area where we know there is a need for science is in the area of innovation. Another visit to the dictionary tells me that innovation is creation (of a new device or process) resulting from study and experimentation, or basically, science. At EPA, we're very focused on how innovations can help us achieve greater environmental and public health protection.

One of my priority areas for the Office of Water is sustainable water infrastructure. The infrastructure we've built over the past 100 years is aging, and we risk impairments to water quality and public health protection if we fail to address them. For 2007, EPA's budget proposal includes a $7 million research initiative to evaluate promising innovative technologies to reduce the cost of operating, maintaining and replacing the wastewater collection and drinking water distribution systems that account for most of the infrastructure needs facing water utilities.

Additionally, research on low-technology treatment solutions can have benefits here and abroad. Our research efforts over the past few years to identify and test new technologies for treating arsenic in drinking water are paying off for small communities around the country as new vendors enter the market and drive down prices. Looking into the future, many are interested in identifying whether there are technologies that would allow for removal of multiple contaminants such that EPA could move away from a contaminant by contaminant approach to regulation. We look to science to show us the way to better policy.

Closing

As the Assistant Administrator for Water at the EPA, I know it's important to remember that when we're improving the quality of our nation's waters, we're largely doing it to protect public health. The public should be able to swim at the beach without being afraid of getting sick ... should be able to eat fish without being concerned about eating toxins as well ... and should be able to drink water without being concerned about contaminants that could affect their health.

Science provides us the foundation upon which we can build policy and regulation to ensure that the public can be confident in their environment and in their health. I know that sometimes our policies can disappoint because they must take other factors into consideration, but this does not diminish our respect for science or the researchers who carry out critically important work.

I want to thank Dr. Singer and the rest of the Steering committee for giving me the opportunity to speak to you tonight. I wish you well with the remainder of your meeting and with your ongoing environmental and public health stewardship efforts.

(Prepared by Veronica Blette of the Office of Groundwater and Drinking Water.)

 

 

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