Written Statement

Statement of Dr. Ronald E. Wyzga

EPRI

beforeto the

SenateCommittee on Environment and Public Works Committee

United States Senate

October 2, 2002


 

Table of Contents

 

Page #

Introduction

3

Summary

4

Scientific Issues

89

Conclusions

17

Appendix A

18

 

 

                       

 


Introduction

 

I am Dr. Ronald E. Wyzga.  I work for the Electric Power Research Institute (EPRI), in Palo Alto, California.  EPRI, a voluntarily-funded 501(c ) (3) non-profit organization operating in the public interest, is almost 30 years old and has an annual budget of approximately $350 million.  EPRI’s Environment Sector has an annual budget of approximately $50 million; this makes EPRI one of the largest privately-funded health and environmental research organizations in the world.  Within the Environment Sector, I am responsible for air quality research, including research on the health effects of air pollution.  The results of EPRI’s health and environmental research is published and made publicly available, usually through the peer-reviewed scientific literature.

 

I began my research career working on the relationship between health  and air pollution (specifically particulate matter) while a graduate student at the Harvard School of Public Health, and my doctoral dissertation in biostatistics in 1971 addressed this topic.  Since then I have been actively engaged in environmental health issues.  I have co-authored a book and published over 50 peer-reviewed papers.  I have served on and chaired subcommittees of the National Research Council (NRC), National Academy of Sciences.  I currently serve on the NRC Committee on Research Priorities for Airborne Particulate Matter.  I have also served on or chaired several EPA Science Advisory Board Committees, and I have been appointed a Fellow of the American Statistical Association.  The comments that I present today reflect my personal views and judgments as a scientist who has worked in this area for over thirty years.  These comments should not be construed to be the official opinion of my employer or of any associate.

 

 

 

Summary

 

  

There are a large number of scientific studies that report a link between air pollution and human health.  I have personally been involved in some, and EPRI has supported many more.  The majority of these studies link particulate matter with health effects; however, some of these studies do not show an association with health, and other studies implicate gaseous pollutants in addition to, or in place of particulate matter. In any consideration of the health and air pollution issue, it is important to keep in mind that air pollution is a complex mixture of many different types of gases and particles. Discerning specific causative agents is a challenge we in the scientific community are working to address.   Today I want to highlight some of the work that EPRI has recently been involved in to provide you with some of our latest results.

 

There have been several major facets to our research:

 

1.)                  It is important to understand which specific components of air pollution are associated with health impacts.  In studies undertaken to date, the strongest associations between air pollution and health are with particulate matter.  In studies which include particulate matter (PM) and other pollutants, such as ozone and carbon monoxide (CO), in their analyses, PM is most consistently associated with health responses; there are, however, some exceptions where other pollutants, especially carbon monoxide, are most highly associated with health responses. Very few studies have considered a comprehensive set of the pollutants, especially the different chemical constituents of particulate matter, in their analyses.    This is because monitoring programs currently only measure a small number of compounds.

 

    There are limited data on the toxicity of the different components of particulate matter.  Few toxicology experiments have been undertaken examining the different fractions of PM, but those that have been done have found differences in toxicity for the different fractions. Other results show that the total quantity of PM by weight does not explain biological responses.  Certain components in PM appear to explain the toxicity of PM more readily than total PM.

 

2.)                   The EPRI ARIES (Aerosol Research Inhalation Epidemiology Study) project was designed to examine the toxicity of the various components of PM and air pollution.  This study is unique in terms of the number of air quality parameters measured and the number of health effects examined.  This study, undertaken in Metropolitan Atlanta in conjunction with several universities, US Department of Energy, and others, characterized the air quality on a daily or more frequent basis for over one hundred air quality variables.  This characterization, accompanied by a suite of epidemiological studies, allowed us to examine the influence of the various components of air pollution on a variety of health outcomes. 

 

     In general, the ARIES study is finding that different components of air pollution are associated with respiratory effects than are associated with cardiovascular effects (heart-related effects).  More explanation of the preliminary results is given in the detailed testimony, but in summary, the respiratory effects appeared to be related to the gaseous pollutants (carbon monoxide, ozone, and nitrogen dioxide) and cardiovascular effects were appeared to be associated with PM-2.5 (particles 2.5 microns in size and smaller) and carbon monoxide.  However, the only fraction of PM-2.5 that showed any association with the cardiovascular effects were   particles containing organic and elemental carbon.  It is the
PM-2.5
PM2.5 fraction that has been at the center of attention as the potential cause of negative health impacts.  For total mortality, the pollutants most consistently associated with premature death are oxygenated hydrocarbons, substances that to date have had limited study.

 

3.)                  EPRI has initiated smaller ARIES-like studies in Baltimore and St. Louis to determine whether the results from Atlanta can be replicated elsewhere.   A major effort is also underway to launch a study very similar to ARIES in Chicago.

 

4.)                  A major toxicology effort will start soon in which the effects of coal combustion emissions will be investigated by exposing animals to  diluted, aged emissions from power plants.    This effort will provide important data to help evaluate different combinations of fuel type, control technologies, and burning configurations.  The results of this work will be particularly useful to help inform and complement the research underway at the National Environmental Respiratory Center in Albuquerque, which is also evaluating the toxicity of emissions from diesel and gasoline engines, as well as wood smoke. 

 

5.)                  EPRI has also been active in trying to understand the implications of alternative statistical methods used in the analyses of epidemiological data.  Given the recent discovery that the applications of statistical software have led to erroneous results in some pollution health studies, the EPA is delaying its review of particulate matter health effects.  Other statistical analyses require judgments that can impact their outcome.  It is important to understand these potential impacts.

 

6.)                  EPRI has undertaken studies to understand the nature of exposure to the various constituents of air pollution, including particulate matter and its major constituents.  We have found that there appears to be a better association between personal exposure to particulate matter and outdoor measured levels than there is for many of the gaseous pollutants. 

 

What is particularly important is that recent results suggest that there are short periods of time (in specific environments) when personal exposures to pollutants are much higher (by factors of 5 for PM and over 50 for carbonaceous particles) than the levels that we measure at our monitoring stations.  We also need to establish whether these short-term peak exposures are related to health responses. 

 

7.)                  Our joint study with Washington University of some 50,000 Veterans was designed to answer the question of whether there are long-term (chronic) effects associated with air pollution.  In this study we found that after adjusting for many other factors Veterans who lived in cities with higher levels of nitrogen dioxide and very high ozone levels died earlier than those living in cleaner cities.  We could find no such effect, however, when we examined particulate matter.

 


Scientific Issues

 

There is a clear association between air pollution and health in the US at pollution levels we have experienced in the 1990s and earlier.   Several different types of epidemiological studies, undertaken at a wide variety of locations, have found associations between air pollution and human health effects in the US.  Among the various pollutants examined, the strongest associations between air pollution and health are for particulate matter (PM).  Many of the earlier studies (pre 1990s) considered just one or a limited number of pollutants; in these studies, PM was frequently studied and found to be associated with health effects.  Later studies more frequently examined multiple pollutants.  Most of these studies also found associations between PM and health effects, although a subset of the studies found greater associations between health effects and other pollutants, especially carbon monoxide (CO).  In interpreting the results of these studies, several factors must be taken into account.   First, the pollution measurements used in these studies were made at outdoor monitoring sites; these are not necessarily representative of personal exposures to these pollutants   pollutants.  We now have some limited data on the differences between personal exposures and outdoor measurements. These differences are not the same for every pollutant measured, leading to possible statistical impacts on the results of the analyses of the relationships between air pollution and health.

   

    Second, studies can only consider pollutants for which measurement data are available, and only a few pollutants/substances are generally measured.  If the pollutant(s) that are truly responsible for health effects are not measured, then other pollutants that are measured and present at the same time as the responsible pollutants can be associated statistically with health effects. In such cases what we measure and use in our analyses could be a surrogate for something that is not measured.   In all of our study results we need to keep this in mind.  The only way to overcome this issue is to measure as many components of air pollution as possible, hopefully including the  true culprit (or culprits), which only detailed analyses can reveal.

 

There is as yet no accepted biological explanation for the link between the levels of pollution found in the US today and observed health responses.  Past research has focused on epidemiological studies—observational studies on humans going about their normal activities. .  Laboratory research, which has been limited to date, can focus on establishing the underlying biological mechanisms that can cause negative health effects.  Several possible biological explanations have been put forth to explain the results from epidemiological studies, and recent laboratory results support some of these hypotheses. For example, one study appeared to show that blood clotting can increase with exposure to higher levels of fine particulates. If this occurs, it could be an explanation for why some heart disease effects are related to fine particulate levels in epidemiological studies.   At this time, I believe that the most likely scenario is that a combination of explanations is responsible for the effects observed, with different mechanisms acting for different air pollution/PM components.  Different mechanisms may also be acting in susceptible individuals, such as asthmatics or those with hypertension.  Clearly, much more work is needed to gain insight into the mechanism(s) of PM action.

 

Particulate matter is a complex mixture and its composition varies over time and place.    Some of these major components (e.g., organic matter) contain hundreds of chemical compounds.  The most important fractions of PM are carbon-containing particles and sulfate in the Eastern US, with carbon-containing particles being more important in urban areas.  In the Western US, nitrates are more important and sulfates are generally less important.

 

There are limited data on the toxicity of the different components of particulate matter.   Several PM components have been hypothesized to play a role in toxic responses, including acid aerosols, metals, sulfates, nitrates, ultrafine particles (very tiny particles much smaller than the PM-2.5 particles), bioaerosols (including pollen and mold spores), diesel exhaust particles, and organic compounds.  Toxicological and human exposure evidence suggests that acid aerosols do not contribute much to the adverse respiratory outcomes observed in epidemiological studies; however, acid components have not been assessed thoroughly with respect to potential cardiovascular effects.  Metals have been shown in multiple studies to cause cell injury and other effects. .  Particle size, specifically the ultrafine fraction, may also be important in the development of health effects.  A number of studies have investigated the effects of ultrafine particles and have found lung inflammation and other respiratory effects, although it appears that chemical composition may play a key role in the responses observed.  Cardiovascular and systemic effects of ultrafine particles have been investigated to only a limited extent.  Bioaerosols are not considered to account for the reported health effects of ambient PM as their concentrations are very low and health effects can occur at times when bioaerosol concentrations are low.   Toxicological evidence is accumulating to suggest that diesel PM can exacerbate the allergic response to inhaled allergenic material.

 

Finally, the organic compounds associated with PM have been little-studied from a toxicological perspective, although they represent a substantial portion of the mass of ambient PM (10-60% of total dry mass).  Other fractions of PM, including sulfates and nitrates, appear to be of less concern. 

 

In a recent draft report, the Netherlands Aerosol Programme concluded:  “Based upon current toxicological and human clinical knowledge: water, sea salt, ammonium sulfate, ammonium nitrate, and probably non-crystalline crustal material too, can be considered an inert part of PM-10 at the ambient concentrations in the Netherlands.”  This report has not yet been finalized, and the conclusions are still under discussion.

 

In order to more fully understand which components of PM are responsible for the health effects observed, additional toxicological studies must be conducted.  Studies, which examine the toxicity of emissions from various sources of pollution, can be informative in identifying those pollutants (and sources) most highly associated with health responseseffects. 

 

The EPRI ARIES study was designed to examine the toxicity of the various components of PM and air pollution. This study is unique in terms of the number of air quality constituents measured and the number of health effects examined.  The best way to increase our understanding of the types of PM and air pollution that may be responsible for the health effects observed in other studies is to undertake a study in which all of the potentially relevant fractions of PM are measured. .  Traditionally we only measure what is required because of local, state or federal regulations. On occasion a research study may measure a larger array of air pollutants, but it is rare to have a large number of constituents measured systematically over an extended period of time.  ARIES addresses this need through detailed air quality characterization for a period of over two2 years and through undertaking several epidemiological studies to relate air quality characteristics to health effects.  Appendix A provides further details about ARIES, as well as provisional results..     

 

Extensive daily - and in some cases continuous - measurements were made for all of the particle size fractions and constituents about which concerns have been raised.  At the same time, several epidemiological studies were undertaken to examine the potential health effects of the various constituents. Initial results from the analytical team focused upon the subset of air pollution measures tied to the major existing hypotheses about the pollution/ health relationship. Results based upon the first year’s data have been published in peer-reviewed journals; two years of data have now been analyzed and manuscripts based upon analyses of 2 two years worth of data are now under preparation for peer review.  The draft results are very informative, and I would like to share them with you.    

 

These results are complex and reflect a methodology that examined pollutants individually.  Analyses which consider several pollutants simultaneously are planned and may help identify the pollution components that are of greatest concern.

  

·       Several pollutants are statistically significantly associated with daily mortality of those over 65 years old; they include PM-2.5, PM-10, CO (carbon monoxide), and oxygenated hydrocarbons.  When alternative statistical models were applied, the results were most consistent for oxygenated hydrocarbons, a measure pollutant that has not previously been considered in air pollution health studies.

 

Results are available for several morbidity (disease) measures including emergency room admissions to Atlanta area hospitals, unscheduled physician visits to a health maintenance organization (HMO), and responses of defibrillator devices implanted in patients with erratic heart rhythms.  Preliminary analyses of heart rate variability considered only PM-2.5 and not its components nor gases. Based on these limited data, PM-2.5 was found to be associated with statistically-significant changes in heart rate variabilitys.

 

·       Lung and respiratory problems were related to PM-10 and to pollutant gases including ozone, nitrogen dioxide, and carbon monoxide. 

·        

 

·       Heart disease responses were much more likely to be related to PM-2.5, carbon monoxide, and nitrogen dioxide.

 

·       Organic compounds were associated with several cardiovascular effects.

 

·       When the components of PM-2.5 were considered, the only ones found to be significant were elemental and organic carbon. 

 

 

·       There was little evidence of any health effects tied to acid aerosols.

 

·       No associations were found between any health effect and total soluble metals; additional analyses are planned to look at individual metals.

 

·       No associations were found with ultrafine particles. . Since the concentrations of these particles appear to change so rapidly over time and space, it is doubtful that the ARIES study could shed much light on the effects of these particles.  Nevertheless, their concentrations are unrelated to the concentrations of other particle fractions; hence it is unlikely that ultrafine particles can explain the association seen with other particles.

 

·       No cardiovascular or respiratory effects were associated with sulfates. 

 

ARIES did not look at sources of pollution directly.  We did, however, undertake a source-attribution analysis of the organic compounds in Atlanta.  Cardiovascular effects were found in the winter months only in this study.  In the winter months, organic compound concentrations were tied principally to wood smoke, although diesel emissions were also a contributor.  Diesel emissions were also a major contributor to organic compounds in the summer months when no cardiovascular effects were related to these compounds. 

 

There is a great need for additional studies which focus upon the specific components of particulate matter and examine their relationship to human health.  The ARIES study will provide an important piece of evidence in understanding which fractions of PM and of air pollution are the most important in affecting human health.  ARIES results are from one metropolitan area, Atlanta.  Atlanta is a logical place for a study; it has high pollution levels, many sources of pollution, and no unique sources of pollution that would yield a unique result.  Nevertheless it is important to undertake similar studies in other metropolitan areas.  We are now engaged in similar, although more limited, studies in St. Louis and Baltimore, where detailed monitoring is underway.  Much of this monitoring is funded by EPA’s supersites monitoring program.  Undertaking such studies is expensive because the air quality monitoring itself is costly; hence, governmental resources to undertake such studies are critical.  

 

Secondly, more laboratory studies are needed which examine specific fractions of particulate matter and its toxicity.  Since it would be very costly and time-consuming to test all specific compounds rigorously in laboratories, special protocols should be considered which examine the mixture of pollutants associated with specific sources.  For example, studies are now underway at the National Environmental Respiratory Center to examineing the toxicity of emissions  from several sources.  EPRI is planning some similar efforts, but clearly more research is needed.  There are a large variety of emissions from different sources, and we need to learn how these emissions interact with other pollution elements once they enter the environment at large.   

 

An ongoing committee of the National Research Council, of which I am a member, will issue a report  next year identifying the highest priority research needs to inform particulate matter-health policy issues.

 

The implications of the statistical methods used to investigate the relationship between health and air pollution need to be fully understood.   A recent announcement by researchers at Johns Hopkins University raised some issues about the the past use of one particular statistical approach and its related software. . Fortuitously, at a meeting of EPRI researchers with our advisors, it was decided to use alternative statistical methods in our research, and we have examined these methods thoroughly.  We have found that, on occasion, ARIES results, especially in the mortality analyses, can be influenced by changes in the statistical approach even when the alternative approaches are judged reasonable by statisticians.  For example, carbon monoxide (CO) was found to be statistically significantly associated with daily deaths of those over 65 years old with one approach but not with the other.  Fortunately most results were similar across the various approaches, but but because there are some differences. , iIt is important to articulate and understand these differences. 


 

Conclusions

 

1.                    Air pollution likely impacts the health of individuals in the US today.

2.                    Particulate matter is a likely candidate to explain these impacts.

3.                    Not all fractions of particulate matter appear to be equally toxic.

4.                    When health effects are associated with fine particles, our research points strongly to carbon-containing particles that contain carbon as the agents of concern; in most US cities, carbon-containing particles are also the largest particle component by weight.

5.                    Gaseous pollutants are still of concern and cannot be ignored.

6.                    There is a strong need to identify with more certainty those specific components of air pollution which cause health effects. 

7.                    We need to understand in more detail the personal exposure of susceptible individuals to the various air pollution components.  In particular, we need to identify when and where peak exposures occur and whether these peaks are important to health.

8.                    There is a great need to apply alternative statistical methods in analyzing data and to understand the influence of a specific method.

1.                    Decreasing the non-toxic part of particulate matter will not reduce health risks.

9.                     

 

 

 

 

 

Appendix A

 Fact sheet: Aries: Aerosol Research Inhalation Epidemiology Study