Virtual Guest Speakers 

March 10:

Robert Yuhnke, Public Interest Lawyer
Topic: National Ambient Air Quality Standards
Virtual Lecture  (Real Audio format)
Transcript of Lecture
Other links
Discussion List   (Robert Yuhnke will participate from March 23 - March 30 (tentative)).

Short Biography of Robert Yuhnke

Biography: Robert Yuhnke is a graduate of Canisius College in Buffalo, New York, and Yale Law School.  After graduating from law school, he worked in the Pennsylvania Attorney General's office, enforcing the State's environmental laws.  He subsequently worked with the United States Department of Interior and, in 1980, joined the Environmental Defense Fund (EDF).  As counsel for EDF, he has brought numerous lawsuits to enforce the federal Clean Air Act, and he is a nationally respected expert in air pollution control law.

Virtual lecture

National Ambient Air Quality Standards and the American Lung Association case

This lecture is recorded in RealAudio format.  To download the free RealAudio Player, click here.

Transcript of lecture

David Getches:   Introduction (not transcribed).

Robert Yuhnke:

The National Ambient Air Quality Standards are the heart and core of the Clean Air Act. This is a provision of the law that was first enacted in 1970, in that watershed year of the environmental movement when Congress passed and sent to the President NEPA, and they made a major rewrite to the Clean Air Act, and in that rewrite to the Clean Air Act in 1970, created an obligation for the Federal Government to set standards for the first time to determine the levels of air quality that were to be considered safe for the public to breathe, and which were in turn to drive virtually all the other major elements of the Clean Air Act, except for the regulation of the air toxics.

The National Ambient Standards are a test that have to be met when a new source proposes to build in a locale, and if the new source cannot demonstrate that the National Standards will be met, it can't get a permit, and it can't build. The Ambient Standards affect whether or not industrial activity that is already ongoing has to install emission controls to meet those standards and to determine whether or not that industrial activity can be expanded in an area where the National Standards, the Health Standards, are already being violated. It has driven the design of our automobile engines and emission control systems. It has affected the choice of fuels and reformulation of fuels for automobiles, for stationary sources, such as power plants, and other major industries. It has resulted in changes to the way we design our cities. One of the major amendments to the Clean Air Act that I worked on in 1990 has to do with using the National Ambient Standards as a basis for setting design criteria to determine how we are going to design the transportation systems of the future for our metropolitan areas.

The overall consequence of the National Ambient Standards, according to a study that EPA completed a couple of years ago in attempting to cost out what we have spend to clean up the air in this country since 1970, it's in the order of one-third of a trillion dollars. That's not pocket change. That represents, I think, the largest private investment in achieving a publicly defined goal of any national program in the history of the United States. This has significantly transformed the face of American industry, the face of our cities, and the way we are going to be addressing the future.

What is it about these National Standards that gives them the power to drive this kind of change and major investment in a culture where often times it seems like industrial political might is dominant, and can drive many decisions without regard to their consequences? At the core of the National Ambient Standards is the duty to protect public health. When you look at the health issues that are associated with the protection provided by the National Standards, you can see that they truly represent the largest commitment of any national environmental program with regard to the overall impact on the public health of the people of this country.

Particulate matter, alone, which is one of the pollutants regulated by a National Ambient Standard, is estimated by health researchers at Harvard, Wilson & Spangler, who just produced a recent survey of the evidence of the health effect associated with particulate, will count for sixty to sixty-five thousand deaths per year in the United States. When you compare that with other major causes of death which we have spent a lot of time being concerned about, like aids for example, where the death rate is somewhere between twenty and twenty four-thousand per year, or breast cancer, where the death rate is about forty-five thousand per year, or twenty-five-thousand per year from drunk driving, particulate matter death toll clearly ranks at the top of the public health concerns of this Nation. When you look at the costs of these adverse health consequences, for example, in the EPA's review of the costs of health affects for particulate matter, which they performed last year as part of their review of National Standards with particulate, EPA estimated that the overall health costs of particulate are around 220 billion dollars per year, and that that results from the combination of the costs associated with lost lives, cost of medical care, for people with bronchitis, asthma, respiratory infections, other kinds of disease related to particulate, lost time on the job, kids who lose time from school. All of those costs represent a major cost to the American economy.

Those factors, the health consequences, the fact that the public became particularly aware of those consequences back in the late 1960 and early 70's when this law was the focus of Congressional attention, and the continuing public awareness of the need to address these concerns to the implementation of that law over the last almost thirty years, have been the underpinnings of how these standards have supported a program that has required this kind of change in our culture, and the kind of public and private investment that we have made to address these issues. When you look at the overall health issues associated with air pollution, most people do not think of it in terms of the deaths. Most people think of it in terms of their own personal experience with pollution.

One of the things that we have lost sight of over the last thirty years as we continue to make major progress toward achieving these standards, and now that the air, for example, in Denver has actually achieved all of the National Ambient Air Quality Standards, we forget the fact that back in the late 60's early 70's, cities like Denver were violating the National Standards as much as one hundred sixty to one hundred eighty days per year, so that one day out of two, or one day out of three, the air was not healthy to breathe, that the consequence for that was that many people, thousands, on any given day, would be ending up either at the hospital emergency room door, in their doctor's office, or having to stay home because of the consequences that they experienced on an immediate, day-to-day basis. It didn't just affect the elderly, and the young, although they were affected the most, but it affected even adults who otherwise thought they were healthy, and found that they had a hard time functioning in the pollution environment that existed in those days. That experience of a nation of cities all across the nation, where millions of people were being affected at least two or three days out of every week by pollution and often more, drove Congress, in 1970, to attack this issue with a level of commitment that is not seen in most environmental statutes.

Some of the background to the Congressional action in 1970 is important. It's not only this experience of people being confronted with pollution almost on a daily basis, but the pollution levels then were so severe in many cases, that the public health agencies in cities like New York, or Philadelphia, or Washington, D.C., or Chicago, were calling public health alerts, and there were frequent broadcasts on the radio, and television, advising people to stay home, particularly the elderly, and to stuff towels around their windows to make sure the pollution didn't come in, to keep the kids off the street, so that the kids were kept in doors, or sent to school, after school, so that they weren't out playing in the pollution. This was the kind of thing that affected almost everyone's lives in a very immediate way and Congress had first addressed this threat to the public well-being in l967, with an amendment to the Act that required the States, for the first time, to set public health standards. This was something that had not been done before.

Pollution control, prior to the 1967 amendments, that were called the Air Quality Act of 1967, were really aimed at the very first rudimentary efforts to put pollution controls on automobiles, which were known to be the major source of the problems in our cities, at least the primary source, if soon not the exclusive source, but definitely the primary source, and to begin the very early efforts of trying to control industrial sources of pollution, but there had not been any concept of setting standards for determining what levels of air quality had to be achieved. In 1967, Congress directed the States to do that for the first time, and set in motion a procedure that would involve public hearings, involve experts in this field, involve the federal government at the level of trying to accumulate all the research evidence of what the public health consequence of air pollution were, and using that information to make that available to the States to make choices about the cleanness of the air to be achieved. But by 1970, three years after that first statute was passed, only two metropolitan areas of the United States had gotten to the point of actually adopting the standards, and beginning to explore what was needed to meet those standards, and so this program had essentially failed to make any significant progress, and the public concern about this issue was rising dramatically.

I had a personal experience in the Fall of 1970 at Thanksgiving time, during a break from my law school career, driving down from Connecticut to Washington, D.C. to visit friends, and the entire drive down the east coast was under a pall of pollution so thick that on the New Jersey Turnpike, people had their headlights on. It was not because there were any clouds in the sky, or any fog. There was no atmospheric moisture to account for what was happening. It was a cloud of pollution of such an intensity that you could barely see the cars on the other side of the Turnpike. It was like driving through a fog bank. That phenomenon hovered over the east coast blanketing New York City, Philadelphia and Baltimore for five days. It caused such severe health consequences that it became the final impetus for the support that ultimately materialized and almost a unanimous vote in the Congress in the 1970's to amend the Clean Air Act.

The Clean Air Act of 1970 started off as the National Ambient Fair Standards Act, which was submitted to the Congress by President Nixon, who was responding to what he perceived to be a widespread public outcry for action to solve this public health problem. When Congress was debating the Clear Air Act in 1970, one of the issues that was raised was, "how do we know we can meet these standards? How do we know we are not going to shut down virtually all of industry in this country? How do we know that we are going to be able to build automobiles that can achieve these standards?" And there were no answers to that. There were no emission controls on automobiles that were perceived to be anywhere near adequate. The only emission controls had been developed at that time or in response to standards set in 1968. The first cars were tested for compliance with those standards in 1970 by the Federal Agency. At that time it wasn't yet called EPA. Most of the cars failed those tests, even though Detroit had supposedly designed the cars to meet those very first standards (that would have required very modest reduction in tailpipe emission.)

The automobile industry came into the Congress and said, "if you make us try to control cars to the levels that the 1978 Amendment would have required," (which was across the board 90% reduction in of all the emissions of concerns, which included carbon monoxide, hydrocarbons, and nitrogen oxide), the auto industry experts were telling the Congress, "you are going to shut down the automobile industry. We are not going to be able to produce an automobile that could meet those standards." Congress, in one of the most courageous steps, I think, that one can probably find in the history of environmental law, or may many other statutory programs, Congress said to the automobile industry, you are going to have to do this, there is no choice. The American people are not going to accept the quality of air that is damaging their lives, causing disease in their children, causing old people to die ahead of their times. This is not an acceptable outcome. Embedded in the Clear Act was the notion, or the policy, that the pubic health came first, and that the public health was the primary goal, not to be compromised by economic, or technological feasibility consideration. Now, this is not a concept that you will find in most other environmental statutes, but it was driven by the political reality, the public health consequences, and the technological uncertainties of the era of 1970.

The consequence of that policy we now benefit from today. The fact that Denver now meets all of the National Ambient Air Quality Standards, is a product of that choice by Congress in 1970 to demand that industry, whoever it is that's responsible for pollution, bear the cost, not only of installing pollution controls, but of the technological development needed to create new technologies that were not envisioned in 1970, even by engineers working in the back rooms of the design centers in Detroit, and for public policy to say that the public health and the environment had to be the ultimate objectives here. In that debate in 1970, there are some very critical comments, particularly by Senator Muskie, who is the author of the 1970 Amendments, who is responsible for, he was the Chairman of the Environment Subcommittee, the Senate responsible for producing this bill, and for managing it through the floor debates. Senator Muskie set out a challenge to the American industry, saying essentially, our job here at Congress is to say what must be accomplished, and your job is to figure out how to do it. If you can't do it, and if it looks like we are going to start shutting down industries, you have to come back to us, the elected representatives of the people, and explain your case, but we are not going to take no for an answer. So, it was, in a sense, a game of political chicken on the part of Congress, confronting American industry with a challenge that has since largely been met. It is a challenge that it is important to keep in mind as we began to love forward now in the next century to our generation's challenge, or your generation's challenge, which is global warming. This lesson of technology forcing, which is the way the Supreme Court characterized this policy in the landmark case of 1976 of Union Electric v. EPA, that policy of technology forcing proved the creativity of American industry, and of their ability to respond to political goals, and environmental objectives that were defined clearly, and set out as an objective that they had to meet if they were going to continue to survive economically.

Now, as we look toward the future, there are some important decisions that EPA, in the 1990's, is making with regard to how this part of the Clean Air Act is to be carried out. The first standards set under the Clean Air Act by EPA were set just four months after the law was passed, April 1971, based upon what were called criteria documents that had been issued by the Federal agencies prior to the 1971 Amendments, so that the scientific analysis on which the first standards were based had already been done, and that was the research that Congress was looking at when it decided that these issues were urgent, and demanded a political response that was equal to that urgency. And those first standards, because they were based upon scientific evidence that had been out in the public domain for a number of years, that the States had been looking at, and arguing about, and that industry had been engaged in a dialogue around, didn't result in any significant litigation.

The first standards that really prompted judicial review of actions taken under this provision of the Clean Air Act resulted from the 1977 amendments to the act, which required EPA to take some action on reviewing the standards that had been first set in 1991, and also, in response to a court case that was won by NRDC in 1976, requiring EPA to set a national standard for lead, which the Federal agency had otherwise declined to do. The lead history is an interesting example of how this law has forced change.

The first decision by EPA to address the health affects associated with lead was made back in 1974, but it wasn't focused primarily on the health effects of lead themselves. When you go back and look at the scientific understanding of the health consequence of lead in 1974, it was extremely primitive. We now know that lead has the effect of interfering with the function of the central nervous system, and its most damaging long terms effect, at levels below what are physically toxic, for purposes of actually causing physiological responses, below that level, it interferes with brain functions, so as to keep children from being able to learn, and has the potential for preventing a whole generation from intellectually maturing. And while that is now something that we can understand, clearly, in 1974, that was not understood at all.

EPA took an action in 1974 to begin what is known, now, in retrospect, as the lead phase down program, to take lead out of fuel. The main reason for that was that the lead in fuel, which was a routine component of virtually all gasoline, except for that make by Amoco, as of the early 70's, all other gasoline contained lead, the lead was, at that time, seen as a major contaminant of the emission control devices that were being installed on automobiles, the catalysts, that were designed to break up nitrogen oxides and hydrocarbons in the tailpipe, before those components of the exhaust gases from the engine made it out into the atmosphere, and the lead would poison the catalyst, by essentially coating the surface of the baffles in the catalyst, and kept the catalyst from performing its functions. So, the controls that were being designed to control these other pollutants, all of which had standards set for them in 1971, were not going to work if lead continued to be part of the fuel supply.

So EPA started that process of phasing down lead out of gasoline, and that decision was challenged by the fuels industry. The lead petitioner was the Ethyl Corporation, which was the largest producer of leaded fuels in the country at that time, and that case was taken to the D.C. Circuit Court of Appeals, where the D.C. Circuit, for the first time, had to grapple with this question of how the Clean Air Act was going to be implemented in the face of very poor evidence of what the health consequences were of some of these pollutants. In that case, EPA defended its decision to begin this phase-down of leaded gasoline on both the grounds that this was necessary so that the vehicle controls would work, but also that it was necessary to protect against the health consequence of lead, which at that time were very poorly known. So, the kind of documentation that we would think of now as being available to show how dangerous exposure to lead in the atmosphere is, wasn't even part of the agency record at that time.

There was virtually no evidence that there was central nervous system damage associated with lead exposure, and in what I think is one of the most significant cases in the history of pollution control, the D.C. Circuit, in a split vote, I believe that it was six to five, but it might have been five to four, but it was by one vote in a full panel review of the agency's position, affirmed what EPA had done, and affirmed it on the grounds that the Agency's obligation under the Clean Air Act was to put health first, and to take into account, as best it could, the uncertainties about the health consequences of the pollutants being regulated, and that the Court said, instead of adopting the industry view, which was, "you can't regulate us, you can't impose, on industry, cost of reducing pollution until we know that those costs are actually going to produce some health benefits, and here we don't know that. There is no certain evidence that, by taking lead out of the atmosphere, the health of anybody is going to improve," and the Courts said no, we don't need that level of proof. Under the policy Congress adopted in the Clean Air Act, what we need from the Administrator of EPA is a rational basis for concluding that there might be adverse health consequences from allowing millions of American to be exposed to this contaminant in the ambient air. The responsibilities that Congress gave to the Administrator was to protect the public health, and to do it in a way that prevents harm before it happens, and if that means making decisions based upon uncertainties about what the health consequences of a particular contaminant are, and the Administrator has a rational basis for believing that there might be significant adverse health consequences, that is enough to sustain the decision to regulate.

Now, that was really a major threshold in the development of pollution law in this country. Courts were rarely pushed to that limit again by EPA. EPA has not relied significantly on that authority to address the uncertainties in the health affects database to make a decision to regulate a contaminant. That case has served as an underpinning for the whole regulatory approach that has since evolved out of the National Ambient Standards provision of the Clean Air Act. So, finally, four years later, when the Agency was under a court to set a national standard for lead, keeping in mind that the first case, the Ethyl case, was only with regard to taking lead out of gasoline, but it wasn't looking at the total exposure to lead in the ambient in the air in all sources, including stationary sources, when the Agency finally looked at the question of setting a National Ambient Standard, it had more data, and, within that intervening period of time, the evidence of damage to the central nervous system had begun to emerge from the research projects of the medical communities. So, there was clear evidence that that was a potential effect, although the level at which that effect occurred was still highly uncertain. At that point, EPA was confronted with the question of, "how do we apply this statute in the case where we don't know what the safe level of air is, the safe level, in that case, of lead in the ambient air. We don't really know the level at which children might be adversely affected. We know that the levels at which children are being exposed in the ambient air does cause interference with central nervous system functions. Those were levels up in the range of concentration that produced blood lead concentrations of forty to sixty deciliters, and that those concentrations were known to have adverse health effects. So, the Agency was confronted, for the first time, with really trying to apply a provision of the act that reflects, in legislative language, this policy that Congress enacted in l977, of putting public health first and being technology forcing. The language is the requirement of the national standards to protect the public health with an adequate margin of safety. So, the issue there, and virtually all the litigation, and all the standard-setting by EPA under this provision since then, has focused on this language. What does it mean to protect public health with an adequate margin of safety?

In l978, when the agency was making this decision on lead, the Assistant Administrator for Air was David Hawkins, who I am sure David knows, and he is a contemporary of ours, having come out of the environmental community, he was one of the chief air quality lawyers for the Natural Resources Defense Council in the early 70's, and had been responsible for the some of the major litigation in the early 70's to force implementation of the Clean Air Act, but in the Carter Administration in 1978, he was sitting in the chair of the person responsible for actually making these standard-setting decisions, which, ultimately, is the decision of the Administrator, and as we've learned over time, it is very much a decision of the President. Just because Congress says that the Administrator will make this decision, doesn't means that the buck stops there. But Hawkins was the man responsible for pulling all this together, and putting together the theories, trying to make this part of the act work.

So, the Agency adopted a theory that said, we must at least set the standard at a level below the level where we know there are observed adverse health affects, otherwise margin of safety doesn't mean anything. So that was the theory the Agency took in applying the statute to the lead tax in 1978, and then, again, when it reviewed the Ozone Ambient Standard in 1979, and that theory was then challenged by industry in the lead industry in the Lead industries case in the D.C. Circuit, which is probably one of the readings that you had, where the Court, for the first time, reviewed the application the statutory test, and adopted the EPA's interpretation, saying the margin of safety test, at a minimum, means that you have to prevent known adverse health consequences. And then, once you have done that, what the Court said, was that the margin of safety, which is a level of protection beyond what is known, is within the realm of the agency's discretion, and is virtually unlimited, that Congress has imposed no limits on the Administrator's exercise of that discretion, to determine how large or how wide that margin of safety will be. But the starting point is the threshold of known adverse effects. That was the rule that the Agency applied consistently down through it subsequent reviews of the other standards, which were required, as a result of the 1977 Amendments, to be reviewed every five years for their adequacy, so that any new developments in the science, in what we knew about the health consequences of these pollutants, would get factored into the standard setting process. When we come down to 1987, we have the last of those decisions where that approach was clearly applied, in the review of the particulate matter standard.

If you recall from my opening comments, the particulate matter pollutant has associated with it the greatest public health consequences of any human exposure to environmental contaminants that we know of in the United States. When EPA confronted new data in 1987, with regard to what was known about the health consequences of the particulate matter, it said, "because these health consequences are so severe, and potentially all-encompassing, effecting hundreds of millions of Americans, we have to take a very cautious approach here." What they did was to revise the standards in 1987, so as to focus in on a smaller size particle. Prior to 1987, the standard had focused on particles of virtually unlimited size, and in 1987, they said, we are going to focus on particles only smaller than 10 microns in size, because those are the one that not only gets into nose and throat, but penetrate below that, into the upper respiratory tract, into the bronchial tubes, and the smaller particles, smaller than, say, two to 3 microns in size, are the one that can penetrate into the smallest sacks, the alveoli, in the lungs. So, the Agency said, we are going to focus more on these small particles, and we are going to revise the standard, so that we encompass all the known evidence of levels of exposure at which the public is harmed.

Then, the following year, in 1988, for the first time, and this was under the Reagan Administration, when the Agency was reviewing the National Standard for sulfur dioxide, they said, "we have evidence showing that people exposed to short terms peaks of sulfur dioxide of five to ten minutes for a part per million or greater can be adversely affected, and the population that would experience these effects were asthmatics, who would experience asthma attacks when they were exposed to these plumes of SO2, but for the first time, the agency abandoned its traditional interpretation of what "protecting public health with an ample margin of safety" meant, and proposed, in 1988, not to strengthen the standard, so as to protect people who were experiencing asthma attacks as a result of these SO2 exposure.

At that time, they offered a number of rationales, one of which was that people could take medicine that would protect them, and therefore, why should polluters have to clean up their pollution, and that people could protect themselves by staying away from these sources, because they were stationary sources, they weren't diverse and moving around, like automobiles. Mostly importantly, the Agency suggested that, although up to three hundred-thousand people might be suffering from these asthma attacks, caused by SO2, they didn't think it was enough people to bother to require protection, and this was the first Ambient Standard review that was conducted with a full scale regulatory impact analysis. One of the things that the Lead Industries case decided, back in 1978, was an industry claim that the agency had to look at the cost of pollution control when setting standards under Section 109 of the Act. The Court said no, Congress focused EPA's attention on protecting public health only. That is the only factor that is relevant to the decision to select the level of health protection. There is no other factor that can be weighted against that as a basis for citing to minimize protection. But, in 1987, under the Reagan Administration, the agency developed a cost analysis that was more comprehensive and thicker than the health effects analysis. Of course, they said we are not considering these costs, that's not allowed by the statute, so we generated this 150 or 180-page document to access the cost, but obviously we are not intending to use that for any purpose. That analysis drew into question whether or not the health benefits of protecting these asthmatics from having asthma attacks, which, of course, involve the heath consequences of experiencing these asthma attacks, which in some cases could be very extreme, very debilitating, keeping people from undertaking a normal daily activity, as EPA admitted, sometimes requiring emergence medical intervention, either in the doctor's office, or the emergency room, requiring medication. So, these were not minor or insignificant health consequences, but the question was whether or not the cost that the industry would have to bear to control the major sources of pollution....

So, this brought into question the whole seventeen years or eighteen years of interpretation of the Clean Air Act that had come before, because the agency was starting to bring in other factors to determine what the level of health protection should be, and they refused to make a final decision on that, because they knew that there would be a legal challenge, which they wanted to avoid. So, ultimately, there had to be two cases brought in the District Court to force the Agency onto a schedule to make a final decision about whether or not to carry forward with their refusal to strengthen the health standards for SO2. That decision was finally made in l996, sixteen years after the first Clean Air Act deadline for the review of the SO2 standards, which was supposed to been completed in 1980. The Agency adopted, as it final decision, the rationale put forward in the Reagan Administration, even though, by 1994, this was now the Clinton Administration, and said, in less clear terms than was proposed in 1988, that there were not enough people being harmed by this pollutant in order to justify regulation.

So, at that point, the American Lung Association took that decision to the Court of Appeals, and argued that the statute required the Agency to make sure that standards at least protect against known adverse health affects. Here, we had a clear-cut record where the Agency had identified the adverse health effects, had estimated the numbers of people who would experience those health effects, and had said, despite of all of that, we are not going to protect them. And the record in this case has some interesting facts in it, which don't come through the Court's decision, but which we pointed out to the Court. For example, first of all, there's 20 thousand sources of SO2 in the United States. EPA estimated that there were 6, 200 of those, nationwide, that were large enough in size to create the kind of short term peak exposures that would cause asthmatics to experience asthma attacks. Third, that of those 6,200 sources, their plume impact zones, in other words, the area downwind from those sources where the pollutant concentrations will be high enough to cause these kind of asthma attacks, encompass 98.7% of the American population, so that, when the Agency was saying, there's not enough asthmatics who are going to be affected by this, what they were saying was that they all are going to be affected by it, so we are not really going to protect any them. There's only 2% left who weren't in the impact zone of these major SO2 sources.

What the Agency was relying upon, then, was an analysis where, basically a Monte Carlo analysis, where they said the likelihood that the plume concentration will be high enough when an asthmatic is outdoors and having an activity level that will allow the pollution to penetrate passed the throat into the deeper respiratory tract where these effects are triggered, is only going to happen to 300 thousand people a year, and of those 300 thousand, some of those asthmatics will not respond, because only 80% of the asthmatics will respond at a certain level, and 40% of the asthmatics will respond at a less intense pollutant level. So, EPA went through all these calculations to try to minimize the number of asthmatics that would be exposed, or experience adverse effects. It is close to the maximum number that could possibly be ever exposed, and have these kind of effects.

So, in taking this case to Court of Appeals, this was only the second time that an environmental challenge had been made to a national standard. The only other case was a challenge that had been taken back in 1980 to the EPA's decision to, actually, relax the protection under the ozone standard, and that case was not really a strong case, largely because the evidence in the record of that decision showed that the known adverse health effects of ozone were above the level that EPA was going to set the protection at. So, in other words, EPA had actually set a standard that was more protective than necessary to prevent the known adverse health affects. This was the first time that anybody was challenging a standard on the grounds that the Agency hadn't protected against known adverse effects. And you've read the opinion. The Court didn't ultimately reached that issue. They did agree with us that the Agency had failed to adequately justify its decision.

Basically, what the Court said was, there is case law here, saying that the statute has been interpreted to require protection against known adverse health affects. You have shown that there are adverse health effects here. You haven't explained how you can justify that under these historical precedents. So, in some ways, this was half a victory. The consequences of this decision are very ambiguous at the moment, but we are currently in negotiations with EPA as to whether or not they are going take this issue up with a serious commitment to providing protection or not, and I have some hope that they will. But the Court was obviously unwilling to allow the agency simply to adopt the rationale that they had adopted and declining to extend the protection, which was simply that this is not a big enough problem, there's not enough people being exposed, there's not enough areas around the country where this is an issue.

So, the next decision that EPA made on the National Ambient Standards is by far the most consequential one, and that was the decision, last year, to revise the national standard for particulate matter. That decision has clearly the most widespread public health consequence of any decision that EPA has made since the act was passed in the 1970's, and will have long term consequences for industry, for the development of our cities, for the future of automobile technology. And this is a case where the agency clearly cannot argue, and has not attempted to argue, that the public health consequences are too small to justify regulation. Carol Browner, on the contrary, went to the mat on this one, and under very strong pressure from the President not to adopt the standards that were ultimately adopted, nonetheless, convinced him that this was the right choice.

Now, the question is whether or not that the standards that Agency set fully carry out the policy implied in the duty to set a standard with an adequate margin of safety. And here, we are dealing with an issue which is less clear cut than the SO2 case, because we are dealing with the Agency's evaluation of the data for purposes of attempting to characterize that threshold at which adverse health effects are deemed to occur. In the SO2 case, the evidence of the levels of exposure at which asthmatics experience adverse health effects was fairly clear cut, and it was partly because of the fact that that evidence came out of exposure chambers, where asthmatics, young, relatively, otherwise healthy asthmatics, were put into exposure chambers in experimental situations in medical research labs exposed to SO2 under control conditions, so that all other variables could be excluded, and then their response at different levels of exposure were observed and recorded. That database is pretty compelling and left a very narrow margin of uncertainty about the level of exposure needed to cause these kind of adverse health effects. But, in the case of particulate matter, there are no exposure studies, there are no situations where people have been put into chambers in a lab, and their effects measured, and enough of them observed so that we can have a sense of what that threshold of adverse health effect is.

Instead, the database for particulate matter is based upon studies that have been made performed over twenty years. They include some individual studies that have been performed for a few weeks in a given city, to studies that have been based upon data collected from 151 cities nationwide, for following a cohort of 550 thousand people as part of a National Cancer Institute study/American Cancer Institute study. And, where the data points have a significant amount of scattering, the one thing that is clear about all of these studies is that increased exposure to particulate matter is associated with increased response by the exposed population in terms of various forms of adverse health consequences. So, there is not scattering of the data in the sense that there are some studies where pollution goes up, and health effects go down. There is nothing like that. It wasn't a situation where the EPA was having to resolve conflicting data. Instead, it was a situation where the agency was struggling to tease out of this data the point at which one could clearly say, adverse health consequences start here, and in that database, the first clear indicator of some adverse health consequences appears in the most sensitive study to begin at about nine micrograms per cubic meter of air.

As you know, EPA set the standard at fifteen micrograms. The difference between nine micrograms and fifteen micrograms, if you make an assumption that health affects starts at nine, because the most sensitive study showed statistically significant results beginning at nine micrograms, then what you come up with is an estimate that approximately 64 thousand people are going to die every year, and then on top of that, you might think of it as pyramid, with the deaths at the top of the pyramid, and below that, there's 120 thousand people who are going to experience pretty severe bronchial infections, and below that there's going to be million people who experience asthma attacks, and below that there might be 3 million people who experience less severe respiratory infections. So, it is a pyramid of health affects. If you take that pyramid, and build it on a base that starts at nine micrograms, then, at the top, you are going to be estimating, which the Agency did, that there will be approximately 64 thousand deaths per year from these exposures, and that setting the standard at fifteen only prevents fifteen thousand of those deaths.

So, the question that a number of us in the environmental community who focused on this rule making, and this was the focal point of my article that was in the reading packet, was how can the Agency justify a decision that would that would leave so many people at risk for such severe potential health consequences. And the agency, in its final decision, offers as justification the fact that, at fifteen micrograms, they have the strongest coherence of the data, which means that more studies agree about the adverse health consequences at fifteen micrograms than any other point below that. It's the point at which most studies show adverse health and consequences, and that the magnitude of those adverse consequences is pretty much consistent across studies. But, that doesn't explain why the Agency does not credit the studies which show adverse consequences below fifteen. This is an issue that I think will end up in front of Court of Appeals, again. It's in marked contrast to the choice that the Agency made with regard to particulate matter in 1987, where, at that time, based upon a database that was much smaller, that had more uncertainty associated with it because of the state of science, the Agency said, we have to set the standards at the bottom, which meant, in that case, at the level reflected by the study which shows the first compelling statistically evidence of adverse health consequences. They didn't offer any explanation about why they refused to apply that same approach to a much more compelling database ten years later of 1997. But this will raise, I think, some very interesting questions for the Court, and this going to be a much tricker case. As you saw in the SO2 decision, the Court said, we don't want to touch this science stuff, this is the Agency ball park, we are not going to wade into this, our job is to just to make sure that Agency made a rational decision. So, the question will be whether or not the petitioners can convince the Court that the Agency didn't make a rational decision in 1997, and the basic argument there, I think, is that the Agency didn't apply the logic that is applied in 1987 with regard to particulate, and that this comprise the fundamental to public health policy of the Clean Air Act, which requires that you set a margin of safety in the range where you know you have prevented adverse health affects.

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